11–18–09 Wednesday Vol. 74 No. 221 Nov. 18, 2009
Pages 59473–59890
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Contents Federal Register Vol. 74, No. 221
Wednesday, November 18, 2009
Agriculture Department NorthPoint Energy Solutions Inc., 59532 See Food and Nutrition Service Environmental Protection Agency Centers for Disease Control and Prevention RULES NOTICES Carbofuran; Order Denying FMC’s Objections and Requests Meetings: for Hearing, 59608–59686 Board of Scientific Counselors, National Institute for PROPOSED RULES Occupational Safety and Health (BSC, NIOSH), Approval and Promulgation of Air Quality Implementation 59567–59568 Plans: California; Motor Vehicle Inspection and Maintenance Children and Families Administration Program, 59496–59497 NOTICES Proposed Authorizations of State Hazardous Waste Award One Expansion Supplement Grant, 59560 Management Program Revisions: Oregon, 59497–59501 Coast Guard NOTICES RULES Meetings: Drawbridge Operation Regulations: FIFRA Scientific Advisory Panel, 59533–59536 Delaware River, Between Tacony, PA and Palmyra, NJ, Pesticide Products: 59476–59477 Registration Applications for a New Active Ingredient Three Mile Slough, Rio Vista, CA, 59477–59478 Flutriafol, 59536–59537 PROPOSED RULES Pesticide Registrations: Meetings: Xylene, 59537–59538 Implementation of 1995 Amendments to International Convention on Standards of Training, etc., 59502– Executive Office of the President 59503 See Presidential Documents NOTICES Certificates of Alternative Compliance: Export–Import Bank Offshore Supply Vessel GRANT CANDIES, 59580–59581 Offshore Supply Vessel TERREL TIDE, 59580 NOTICES Meetings: Economic Impact Policy, 59538 National Offshore Safety Advisory Committee, 59581– 59582 Federal Aviation Administration RULES Commerce Department Class D and Class E Airspace; Amendment: See Foreign-Trade Zones Board New Orleans NAS, LA, 59475 See International Trade Administration Class E Airspace; Amendment: See National Oceanic and Atmospheric Administration Mankato, MN, 59475–59476 PROPOSED RULES Defense Department Airworthiness Directives: See Navy Department Airbus Model A300 B2 and A300 B4 Series Airplanes et al., 59483–59488 Education Department Boeing Model 747–100, 747–100B, 747–100B SUD, 747– RULES 200B, 747–300, 747SR, and 747SP Series Airplanes, Race to the Top Fund, 59688–59834 59488–59491 NOTICES Bombardier Model CL–600–2B19 (Regional Jet Series 100 Applications for New Awards (FY 2010): and 440) Airplanes, 59480–59483 Business and International Education Program, 59527– Proposed Establishment of Class E Airspace: 59531 Bryce Canyon, UT, 59492–59494 Race to the Top Fund, 59836–59872 Monterey, CA, 59491–59492 NOTICES Employment and Training Administration Meetings: NOTICES RTCA Special Committee 206/EUROCAE WG 76 Plenary; Requests for Certification of Compliance: AIS and MET Data Link Services, 59601–59602 Rural Industrialization Loan and Grant Program, 59586– Noise Compatibility Program (NCP): 59587 Louisville International Airport, Louisville, KY (SDF), 59602 Energy Department NOTICES Federal Communications Commission Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 59531–59532 Agency Information Collection Activities; Proposals, Application to Export Electric Energy: Submissions, and Approvals, 59538–59539 Constellation NewEnergy, Inc., 59532–59533 E911 Location Accuracy, 59539–59540
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Federal Deposit Insurance Corporation PROPOSED RULES NOTICES Total Inward Leakage Requirements for Respirators; Public Determination of Insufficient Assets to Satisfy Claims Meeting, 59501–59502 Against Financial Institution in Receivership, 59540– 59541 Health Resources and Services Administration NOTICES Federal Election Commission Meetings: NOTICES Advisory Committee on Heritable Disorders in Newborns Meetings; Sunshine Act, 59541 and Children, 59564
Federal Maritime Commission Homeland Security Department NOTICES See Coast Guard Agreements Filed, 59541 See Transportation Security Administration Ocean Transportation Intermediary Licenses: See U.S. Customs and Border Protection Applicants, 59541–59542 Reissuance, 59542 Housing and Urban Development Department Revocations, 59542 NOTICES Funding Availability (NOFA) for HUD’s Fiscal Year (FY) Federal Reserve System 2009 HOPE VI Main Street Grants Program, 59582 NOTICES HUD’s Fiscal Year (FY) 2009 NOFA for Section 202 Meetings; Sunshine Act, 59541 Supportive Housing for the Elderly: Technical Correction, 59582 Federal Trade Commission HUD’s Fiscal Year (FY) 2009 NOFA for Section 811 Housing for Persons with Disabilities (Section 811 NOTICES Program): Granting of Request for Early Termination of the Waiting Technical Correction, 59582–59583 Period under the Premerger Notification Rules, 59542– 59544 Indian Health Service NOTICES Food and Drug Administration Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 59544–59545 Agency Information Collection Activities; Proposals, Loan Repayment Program for Repayment of Health Submissions, and Approvals, 59545–59549, 59553– Professions Educational Loans, 59561–59564 59560 Filing of Color Additive Petitions: Interior Department Sauflon Pharmaceuticals Ltd., 59560 See National Park Service Meetings: Anti-Infective Drugs Advisory Committee; Admendment, International Trade Administration 59570–59571 NOTICES Risk Evaluation and Mitigation Strategies for Certain Antidumping: Opioid Drugs, 59568–59569 Brass Sheet and Strip from Germany, 59523 Memorandum of Understanding Between Food and Drug Countervailing Duty: Administration and Waterfront Media, 59571–59578 Polyethylene Terephthalate Film, Sheet, and Strip (PET Request for Comments and for Scientific Data and Film) from India, 59526 Information: Acrylamide in Food, 59579 International Trade Commission NOTICES Food and Nutrition Service Investigations: NOTICES Probe Card Assemblies, 59584–59585 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59520–59523 Labor Department See Employment and Training Administration Foreign-Trade Zones Board NOTICES NOTICES Agency Information Collection Activities; Proposals, Applications for Subzone: Submissions, and Approvals, 59585–59586 Foreign-Trade Zone 119—Minneapolis, MN, 59523–59524 Foreign-Trade Zone 175—Cedar Rapids, IA, 59524 National Aeronautics and Space Administration RULES Health and Human Services Department Patents and Other Intellectual Property Rights, 59476 See Centers for Disease Control and Prevention NOTICES See Children and Families Administration Meetings: See Food and Drug Administration NASA Advisory Council; Science Committee; Planetary See Health Resources and Services Administration Science Subcommittee, 59587 See Indian Health Service See Indian Health Service National Highway Traffic Safety Administration See National Institutes of Health PROPOSED RULES See Substance Abuse and Mental Health Services Petition for Approval of Alternate Odometer Disclosure Administration Requirements, 59503–59508
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National Institutes of Health Securities and Exchange Commission NOTICES NOTICES Agency Information Collection Activities; Proposals, Self-Regulatory Organizations; Proposed Rule Changes: Submissions, and Approvals, 59557–59558 Chicago Board Options Exchange, Inc., 59592–59594 Government-Owned Inventions: New York Stock Exchange LLC, 59596–59599 Availability for Licensing, 59560–59561 NYSE Amex LLC, 59599–59601 Meetings: NYSE Arca, Inc., 59590–59592, 59594–59596 Advisory Committee to the Director, NIH, 59571 Center for Scientific Review, 59567, 59569–59570 Substance Abuse and Mental Health Services Eunice Kennedy Shriver National Institute of Child Administration Health and Human Development, 59565 National Cancer Institute, 59569 NOTICES National Center for Complementary and Alternative Agency Information Collection Activities; Proposals, Medicine, 59566 Submissions, and Approvals, 59549–59553 National Center for Research Resources, 59565–59566 National Heart, Lung, and Blood Institute, 59569–59570 Surface Transportation Board National Institute of Biomedical Imaging and NOTICES Bioengineering, 59564–59565 Trackage Rights Exemption: National Institute of Dental and Craniofacial Research, Union Pacific Railroad Co., 59602–59603 59565 Thrift Supervision Office National Institute of Diabetes and Digestive and Kidney NOTICES Diseases, 59566 Agency Information Collection Activities; Proposals, National Institute of Neurological Disorders and Stroke, Submissions, and Approvals, 59603–59604 59567 Applications: Northwest Bancshares, Inc., Warren, PA, 59604 National Oceanic and Atmospheric Administration Appointment of Receiver: RULES Home Federal Savings Bank, Detroit, MI, 59604 Fisheries of the Exclusive Economic Zone Off Alaska: Reallocation of Halibut in Gulf of Alaska, 59479 Transportation Department PROPOSED RULES See Federal Aviation Administration 2010 Annual Determination for Sea Turtle Observer See National Highway Traffic Safety Administration Requirement, 59508–59519 See Surface Transportation Board NOTICES See Transportation Security Administration Applications: Endangered Species; File No. 14510, 59525–59526 Transportation Security Administration Marine Mammals; Photography Permit, 59524–59525 PROPOSED RULES Meetings: Aircraft Repair Station Security, 59874–59890 Gulf of Mexico Fishery Management Council, 59526– 59527 Treasury Department See Thrift Supervision Office National Park Service NOTICES NOTICES Accessibility to Department of Treasury Conducted National Register of Historic Places: Programs and Activities by Individuals with Pending Nominations and Related Actions, 59583–59584 Disabilities: Weekly Listing of Historic Properties, 59583 Public Comments, 59603 U.S. Customs and Border Protection Navy Department NOTICES NOTICES Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals, 59579–59580 U.S. Naval Academy Board of Visitors, 59527 Custom Brokers User Fee Payment (2010), 59581
Nuclear Regulatory Commission Veterans Affairs Department NOTICES RULES Environmental Impact Statements; Availability, etc.: Servicemembers’ Group Life Insurance—Dependent Naval Medical Research Center, Bethesda, MD, 59588– Coverage, 59478–59479 59590 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59604–59605 Postal Service PROPOSED RULES Unpaid and Shortpaid Information Based Indicia Postage Separate Parts In This Issue Meters and PC Postage Products, 59494–59496 Part II Presidential Documents Environmental Protection Agency, 59608–59686 PROCLAMATIONS Special Observances: Part III America Recycles Day (Proc. 8453), 59473–59474 Education Department, 59688–59834
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Part IV Reader Aids Education Department, 59836–59872 Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. Part V To subscribe to the Federal Register Table of Contents Homeland Security Department, Transportation Security LISTSERV electronic mailing list, go to http:// Administration, 59874–59890 listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
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CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.
3 CFR Proclamations: 8453...... 59473 14 CFR 71 (2 documents) ...... 59475 1245...... 59476 Proposed Rules: 39 (3 documents) ...... 59480, 59483, 59488 71 (2 documents) ...... 59491, 59492 33 CFR 117 (2 documents) ...... 59476, 59477 34 CFR Ch. II ...... 59688 38 CFR 9...... 59478 39 CFR Proposed Rules: 111...... 59494 40 CFR 180...... 59608 Proposed Rules: 52...... 59496 271...... 59497 42 CFR Proposed Rules: 84...... 59501 46 CFR Proposed Rules: 10...... 59502 11...... 59502 12...... 59502 15...... 59502 49 CFR Proposed Rules: 580...... 59503 1520...... 59874 1554...... 59874 50 CFR 679...... 59479 Proposed Rules: 222...... 59508
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Federal Register Presidential Documents Vol. 74, No. 221
Wednesday, November 18, 2009
Title 3— Proclamation 8453 of November 13, 2009
The President America Recycles Day, 2009
By the President of the United States of America
A Proclamation Every day, Americans who recycle conserve valuable resources while reduc- ing our Nation’s carbon footprint. The reprocessing of materials is funda- mental to our future prosperity, as recycling helps preserve our natural environment and sustain our economy. Recycling in the United States is a $236 billion industry, employing 1.1 million workers nationwide in 56,000 businesses. On America Recycles Day, we celebrate the individuals, commu- nities, local governments, and businesses that recycle their waste and contin- ually think of innovative ways to use materials that might otherwise be discarded. Recycling improves our daily lives and helps to protect our planet for the future. Through recycling, we conserve energy, consume less of our precious natural resources, decrease the amount of waste deposited in land- fills, and reduce greenhouse gas emissions. Communities across America also benefit by avoiding the pollution associated with the extraction of raw materials and their processing into finished products. If we are to manage materials and products on a life-cycle basis, we must responsibly use and reuse our resources. Curbside recycling, electronics collection drives, community composting programs, and other similar meth- ods contribute to the success of our efforts. Our Nation’s health and prosperity depends on the productive and sustainable use of our environment. By recommitting ourselves to recycling, we have the opportunity to secure our long-term success and ensure a bright future for the next generation of Americans. NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim November 15, 2009, as America Recycles Day. I call upon the people of the United States to observe this day with appropriate programs and activities, and I encourage all Americans to continue their recycling efforts throughout the year.
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IN WITNESS WHEREOF, I have hereunto set my hand this thirteenth day of November, in the year of our Lord two thousand nine, and of the Independ- ence of the United States of America the two hundred and thirty-fourth.
[FR Doc. E9–27860 Filed 11–17–09; 8:45 am] Billing code 3195–W9–P
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Rules and Regulations Federal Register Vol. 74, No. 221
Wednesday, November 18, 2009
This section of the FEDERAL REGISTER airspace designations are published in Procedures (SIAP) at Mankato Regional contains regulatory documents having general paragraph 5000 and 6002, respectively, Airport, Mankato, MN. The FAA is applicability and legal effect, most of which of FAA Order 7400.9T signed August taking this action to enhance the safety are keyed to and codified in the Code of 27, 2009, and effective September 15, and management of Instrument Flight Federal Regulations, which is published under 2009, which is incorporated by Rule (IFR) operations at Mankato 50 titles pursuant to 44 U.S.C. 1510. reference in 14 CFR Part 71.1. The Class Regional Airport. The Code of Federal Regulations is sold by D and Class E airspace designations DATES: Effective 0901 UTC, February 11, the Superintendent of Documents. Prices of listed in this document will be 2010. The Director of the Federal new books are listed in the first FEDERAL published subsequently in the Order. Register approves this incorporation by REGISTER issue of each week. Accordingly, pursuant to the reference action under 1 CFR Part 51, authority delegated to me, the subject to the annual revision of FAA geographic coordinates for the Class D Order 7400.9 and publication of DEPARTMENT OF TRANSPORTATION and Class E airspace areas at New conforming amendments. Orleans NAS, Alvin Callender Field, Federal Aviation Administration FOR FURTHER INFORMATION CONTACT: LA, as published in the Federal Register Scott Enander, Central Service Center, October 16, 2009 (74 FR 53161), (FR 14 CFR Part 71 Operations Support Group, Federal Doc. E9–24626; page 53162, column 2), Aviation Administration, Southwest [Docket No. FAA–2009–0405; Airspace are corrected as follows: Region, 2601 Meacham Blvd., Fort Docket No. 09–ASW–12] § 71.1 [Amended] Worth, TX 76137; telephone (817) 321– Amendment of Class D and Class E * * * * * 7716. SUPPLEMENTARY INFORMATION: Airspace; New Orleans NAS, LA ASW LA D New Orleans NAS, Alvin History AGENCY: Federal Aviation Callender Field, LA [Corrected] Administration (FAA), DOT. By removing ‘‘(Lat. 29°49′31″ N., long. On September 3, 2009, the FAA 90°02′06″ W.) and substituting (Lat. published in the Federal Register a ACTION: Final rule; correction. ° ′ ″ ° ′ ″ 29 49 38 N., long. 90 01 36 W.) notice of proposed rulemaking to amend SUMMARY: This action corrects the * * * * * Class E airspace at Mankato, MN, geographic coordinates of a final rule ASW LA E2 New Orleans NAS, Alvin reconfiguring controlled airspace at that was published in the Federal Callender Field, LA [Corrected] Mankato Regional Airport, Mankato, Register October 16, 2009, amending By removing ‘‘(Lat. 29°49′31″ N., long. MN. (74 FR 45574, Docket No. FAA– Class D and Class E airspace at New 90°02′06″ W.) and substituting (Lat. 29°49′38″ 2009–0677). Interested parties were Orleans NAS, Alvin Callender Field, N., long. 90°01′36″ W.) invited to participate in this rulemaking LA. * * * * * effort by submitting written comments DATES: Effective December 17, 2009. The on the proposal to the FAA. No Issued in Fort Worth, Texas, on October 30, comments were received. Class E Director of the Federal Register 2009. approves this incorporation by reference airspace designations are published in Anthony D. Roetzel, paragraph 6005 of FAA Order 7400.9T action under 1 CFR Part 51, subject to Manager, Operations Support Group, ATO the annual revision of FAA Order signed August 27, 2009, and effective Central Service Center. September 15, 2009, which is 7400.9 and publication of conforming [FR Doc. E9–27515 Filed 11–17–09; 8:45 am] amendments. incorporated by reference in 14 CFR BILLING CODE 4910–13–P Part 71.1. The Class E airspace FOR FURTHER INFORMATION CONTACT: designations listed in this document Scott Enander, Central Service Center, will be published subsequently in the Operations Support Group, Federal DEPARTMENT OF TRANSPORTATION Order. Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Federal Aviation Administration The Rule Worth, TX 76137; telephone (817) 321– This action amends Title 14 Code of 14 CFR Part 71 7716. Federal Regulations (14 CFR) Part 71 by SUPPLEMENTARY INFORMATION: [Docket No. FAA–2009–0677; Airspace amending Class E airspace at Mankato, Docket No. 09–AGL–17] MN, adding additional controlled History airspace extending upward from 700 On October 16, 2009, the FAA Amendment of Class E Airspace; feet above the surface for SIAPs at published in the Federal Register a final Mankato, MN Mankato Regional Airport, Mankato, rule amending Class D and Class E AGENCY: Federal Aviation MN, for the safety and management of airspace at New Orleans NAS, Alvin Administration (FAA), DOT. IFR operations. Callender Field, LA (74 FR 53161, ACTION: Final rule. The FAA has determined that this Docket No. FAA–2009–0405). regulation only involves an established Subsequent to publication, an error was SUMMARY: This action amends Class E body of technical regulations for which discovered in the geographic airspace at Mankato, MN. Additional frequent and routine amendments are coordinates for the airport’s Class D and controlled airspace is necessary to necessary to keep them operationally Class E airspace area. This action accommodate Area Navigation (RNAV) current. Therefore, this regulation: (1) Is corrects that error. Class D and E Standard Instrument Approach not a ‘‘significant regulatory action’’
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under Executive Order 12866; (2) is not (Lat. 44°13′12″ N., long. 93°54′45″ W.) Chief Counsels and determines best a ‘‘significant rule’’ under DOT Within a 4.2-mile radius of Mankato methods and practices for providing Regulatory Policies and Procedures (44 Regional Airport and within 1.8 miles each legal advice, assistance, and functional FR 11034; February 26, 1979); and (3) side of the Mankato VOR/DME 167° radial guidance inherent in rendering legal does not warrant preparation of a extending from the 4.2-mile radius to 7 miles services. regulatory evaluation as the anticipated south of the VOR/DME; and within 2.7 miles each side of the Mankato VOR/DME 326° DATES: Effective Date: November 18, impact is so minimal. Since this is a radial extending from the 4.2-mile radius to 2009. routine matter that will only affect air 7 miles northwest of the VOR/DME. This traffic procedures and air navigation, it Class E airspace is effective during the FOR FURTHER INFORMATION CONTACT: is certified that this rule, when specific dates and times established in Robert F. Rotella, Office of the General promulgated, will not have a significant advance by a Notice to Airmen. The effective Counsel, NASA Headquarters, economic impact on a substantial date and time will thereafter be continuously telephone (202) 358–2066, fax (202) number of small entities under the published in the Airport/Facility Directory. 358–4341. criteria of the Regulatory Flexibility Act. * * * * * SUPPLEMENTARY INFORMATION: NASA The FAA’s authority to issue rules Paragraph 6005 Class E Airspace areas Policy Directive NPD 2000.1F, regarding aviation safety is found in extending upward from 700 feet or more ‘‘Authority to Take Certain Actions for Title 49 of the U.S. Code. Subtitle 1, above the surface of the earth. The General Counsel,’’ serves as the Section 106, describes the authority of * * * * * delegation from, and governs such the FAA Administrator. Subtitle VII, delegated authority by, the General Aviation Programs, describes in more AGL MN E5 Mankato, MN [Amended] Counsel to the various designated detail the scope of the agency’s Mankato Regional Airport, MN Agency counsel to carry out such duties authority. This rulemaking is (Lat. 44°13′22″ N., long. 93°55′10″ W.) and responsibilities. NPD 2000.1 promulgated under the authority Immanuel-St. Joseph’s Hospital, MN provides greater implementation details Point In Space Coordinates described in Subtitle VII, Part A, ° ′ ″ ° ′ ″ of the delegation as compared to 14 CFR Subpart I, Section 40103. Under that (Lat. 44 09 48 N., long. 93 57 40 W) part 1245, subpart 5. Accordingly, 14 section, the FAA is charged with That airspace extending upward from 700 CFR part 1245, subpart 5 is superfluous prescribing regulations to assign the use feet above the surface within a 7-mile radius and can be eliminated. of Mankato Regional Airport, and within 2 of airspace necessary to ensure the miles each side of the 047° bearing from the List of Subjects in 14 CFR Part 1245 safety of aircraft and the efficient use of airport extending from the 7-mile radius to 8 airspace. This regulation is within the miles northeast of the airport; and within 4 Authority delegations (Government scope of that authority as it amends miles each side of the 020° bearing from the agencies), inventions and patents. controlled airspace at Mankato Regional airport extending from the 7-mile radius to ■ Under the authority, 42 U.S.C. 2473, Airport, Mankato, MN. 11 miles north of the airport; and within a 14 CFR Part 1245 is amended as follows: 6-mile radius of the point in space serving List of Subjects in 14 CFR Part 71 Immanuel-St. Joseph’s Hospital. PART 1245—PATENTS AND OTHER Airspace, Incorporation by reference, * * * * * INTELLECTUAL PROPERTY RIGHTS Navigation (air). Issued in Fort Worth, Texas, on October 30, ■ 1. The authority citation for Part 1245 Adoption of the Amendment 2009. continues to read as follows: Anthony D. Roetzel, ■ Authority: 42 U.S.C. 2457 In consideration of the foregoing, the Manager, Operations Support Group, ATO Federal Aviation Administration Central Service Center. Subpart 5—[Removed and Reserved] amends 14 CFR Part 71 as follows: [FR Doc. E9–27514 Filed 11–17–09; 8:45 am] PART 71—DESIGNATION OF CLASS A, BILLING CODE 4910–13–P ■ 2. Remove and reserve Subpart 5, B, C, D, AND E AIRSPACE AREAS; AIR consisting of §§ 1245.500 through TRAFFIC SERVICE ROUTES; AND 1245.504. NATIONAL AERONAUTICS AND REPORTING POINTS Charles F. Bolden, Jr., SPACE ADMINISTRATION ■ 1. The authority citation for 14 CFR Administrator. Part 71 continues to read as follows: [Notice (09–098)] [FR Doc. E9–27687 Filed 11–17–09; 8:45 am] Authority: 49 U.S.C. 106(g), 40103, 40113, 14 CFR Part 1245 BILLING CODE 7510–13–P 40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. RIN 2700–AD45 § 71.1 [Amended] Patents and Other Intellectual Property DEPARTMENT OF HOMELAND SECURITY ■ 2. The incorporation by reference in Rights 14 CFR Part 71.1 of the Federal Aviation AGENCY: National Aeronautics and Coast Guard Administration Order 7400.9T, Airspace Space Administration. Designations and Reporting Points, ACTION: Final rule. 33 CFR Part 117 signed August 27, 2009, and effective September 15, 2009: SUMMARY: NASA is amending its [Docket No. USCG–2009–0976] regulations by removing a subpart Paragraph 6002 Class E Airspace Drawbridge Operation Regulation; designated as surface areas. concerning authority and delegations to take certain actions relating to patents Delaware River, Between Tacony, PA * * * * * and other intellectual property rights. and Palmyra, NJ AGL MN E2 Mankato, MN [Amended] The NASA General Counsel establishes AGENCY: Coast Guard, DHS. Agency-wide legal policies and Mankato Regional Airport, MN ACTION: Notice of temporary deviation ° ′ ″ ° ′ ″ procedures in conjunction and (Lat. 44 13 22 N., long. 93 55 10 W.) from regulations. Mankato VOR/DME coordination with the various Center
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SUMMARY: The Commander Fifth Coast except vessel openings will be provided 0967 and are available online by going Guard District has issued a temporary with at least four hours advance notice to http://www.regulations.gov, inserting deviation from the regulations given to the bridge operator at (856) USCG–2009–0967 in the ‘‘Keyword’’ governing the operation of the Tacony- 829–3002 or via marine radio on box and then clicking ‘‘Search.’’ This Palmyra Bridge (Route 73), across the Channel 13. The drawbridge will open material is also available for inspection Delaware River, mile 107.2 between the in the event of an emergency. Vessels or copying at the Docket Management townships of Tacony, PA and Palmyra, that can pass under the bridge without Facility (M–30), U.S. Department of NJ. The deviation is necessary to a bridge opening may do so at all times. Transportation, West Building Ground facilitate the resurfacing of the bridge There are no alternate routes for vessels Floor, Room W12–140, 1200 New Jersey roadway. This deviation reduces the transiting this section of the Delaware Avenue, SE., Washington, DC 20590, vertical clearance of the bridge in the River. between 9 a.m. and 5 p.m., Monday closed position by three feet and The Coast Guard has coordinated the through Friday, except Federal holidays. restricts operation of the draw span. restrictions with the Delaware River FOR FURTHER INFORMATION CONTACT: If DATES: Pilots Association and will inform the This deviation is effective from you have questions on this rule, call or other users of the waterways through 9 p.m. on November 16, 2009, until 5 e-mail David H. Sulouff, Chief, Bridge our Local and Broadcast Notices to a.m. on December 23, 2009. Section, Eleventh Coast Guard District; Mariners of the closure periods for the ADDRESSES: Documents mentioned in telephone 510–437–3516, e-mail bridge so that vessels can arrange their this preamble as being available in the [email protected]. If you have transits to minimize any impact caused docket are part of docket USCG–2009– questions on viewing the docket, call by the temporary deviation. 0976 and are available online by going Renee V. Wright, Program Manager, In accordance with 33 CFR 117.35(e), to http://www.regulations.gov, inserting Docket Operations, telephone 202–366– the drawbridge must return to its regular USCG–2009–0976 in the ‘‘Keyword’’ 9826. box and then clicking ‘‘Search.’’ They operating schedule immediately at the are also available for inspection or end of the designated time period. This SUPPLEMENTARY INFORMATION: Caltrans copying at the Docket Management deviation from the operating regulations requested a time extension to the Facility (M–30), U.S. Department of is authorized under 33 CFR 117.35. temporary change to the operation of the Transportation, West Building Ground Dated: November 6, 2009. California Route 160 Drawbridge, mile Floor, Room W12–140, 1200 New Jersey Waverly W. Gregory, Jr., 0.1, Three Mile Slough, near Rio Vista, CA. Reference docket USCG–2009– Avenue, SE., Washington, DC 20590, Chief, Bridge Administration Branch, by between 9 a.m. and 5 p.m., Monday direction of the Commander, Fifth Coast 0896. The drawbridge navigation span through Friday, except Federal holidays. Guard District. provides a vertical clearance of 12 feet FOR FURTHER INFORMATION CONTACT: If [FR Doc. E9–27635 Filed 11–17–09; 8:45 am] above Mean High Water in the closed- to-navigation position. The drawbridge you have questions on this rule, call or BILLING CODE 9110–04–P e-mail Terrance Knowles, opens on signal as required by 33 CFR Environmental Protection Specialist, 117.5. Navigation on the waterway is Fifth Coast Guard District; telephone DEPARTMENT OF HOMELAND commercial and recreational. 757–398–6587, e-mail SECURITY The drawbridge will be secured in the [email protected]. If you closed-to-navigation position from 8 have questions on viewing the docket, Coast Guard a.m. through 4 p.m. Monday through call Renee V. Wright, Program Manager, Friday, from November 18, 2009 Docket Operations, telephone 202–366– 33 CFR Part 117 through November 20, 2009, to allow 9826. [Docket No. USCG–2009–0967] Caltrans to replace the industrial SUPPLEMENTARY INFORMATION: The staircase leading to the control house. Burlington County Bridge Commission, Drawbridge Operation Regulation; At all other times during this period, who owns and operates this bascule Three Mile Slough, Rio Vista, CA and on November 11, 2009, Veterans drawbridge, has requested a temporary Day Holiday, the drawbridge will open AGENCY: Coast Guard, DHS. deviation from the current operating on signal as required by 33 CFR 117.5. regulations set out in 33 CFR 117.5 and ACTION: Notice of temporary deviation This temporary deviation has been 117.716(b) to facilitate the resurfacing of from regulations. coordinated with commercial and recreational waterway users. There is no the bridge roadway. SUMMARY: The Commander, Eleventh The Tacony-Palmyra Bridge (Route anticipated levee maintenance during Coast Guard District, has issued a 73) at mile 107.2, across the Delaware this deviation period. No objections to temporary deviation from the regulation River, between Tacony, PA and the proposed temporary deviation were governing the operation of the California Palmyra, NJ, has a vertical clearance in raised. Route 160 Drawbridge across Three Mile the closed position to vessels of 53 feet Slough, mile 0.1, near Rio Vista, CA. Vessels that can transit the above mean high water (MHW). This The deviation is necessary to allow drawbridge, while in the closed-to- clearance will be reduced for safety Caltrans to conduct drawbridge navigation position, may continue to do netting by approximately three feet to 50 maintenance. This deviation allows the so at any time. feet above MHW. bridge to remain in the closed-to- Under this temporary deviation, the In the event of an emergency the navigation position during the resurfacing repairs will restrict the drawbridge can be opened with 4 hours maintenance period. operation of the draw span on the advance notice. following dates and times: DATES: This deviation is effective from In accordance with 33 CFR 117.35(e), Closed-to-navigation each day from 9 8 a.m. on November 18, 2009 through 4 the drawbridge must return to its regular p.m. to 5 a.m., from 9 p.m. on November p.m. on November 20, 2009. operating schedule immediately at the 16, 2009 to 5 a.m. on November 24, ADDRESSES: Documents mentioned in end of the designated time period. This 2009; and from 9 p.m. on November 30, this preamble as being available in the deviation from the operating regulations 2009 to 5 a.m. on December 23, 2009; docket are part of docket USCG–2009– is authorized under 33 CFR 117.35.
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Dated: November 4, 2009. attaining the age of 18 and until muscles. Heartbeats are to be J.R. Castillo, completion of education or training (but distinguished from transient cardiac Rear Admiral, U.S. Coast Guard, Commander, not after attaining the age of 23) is contractions; respirations are to be Eleventh Coast Guard District. pursuing a course of instruction at an distinguished from fleeting respiratory [FR Doc. E9–27638 Filed 11–17–09; 8:45 am] approved educational institution. Under efforts or gasps.’’ Model Act section BILLING CODE 9110–04–P Public Law 107–14, stillborn children (1)(b). We do not include in § 9.1(k) the were not eligible for coverage under portion of the Model Act definition that SGLI as insurable dependents. Effective describes what indicates death because DEPARTMENT OF VETERANS October 10, 2008, section 402 of the a child who is not stillborn but later AFFAIRS Veterans’ Benefits Improvement Act of dies, is already a dependent covered 2008, Public Law 110–389, amended 38 under SGLI. Therefore, nuanced 38 CFR Part 9 U.S.C. 1965(10) to include a service distinctions are unnecessary. Pursuant member’s stillborn child as an insurable RIN 2900–AN39 to Congressional intent, our definition dependent under the SGLI program. fully complies with the Model Act. We are adding to 38 CFR 9.1 a new Servicemembers’ Group Life Administrative Procedure Act Insurance—Dependent Coverage paragraph (k) to define the term ‘‘member’s stillborn child’’ as a Because this final rule merely AGENCY: Department of Veterans Affairs. member’s natural child whose death interprets a statutory term, it is an ACTION: Final rule. occurs before expulsion, extraction, or interpretive rule exempt from the prior delivery and: (1) Whose fetal weight is notice-and-comment and delayed- SUMMARY: The Department of Veterans 350 grams or more; or (2) if the fetal effective-date requirements of 5 U.S.C. Affairs (VA) is amending its weight is unknown, whose duration in 553(b). Servicemembers’ Group Life Insurance utero was 20 or more completed weeks (SGLI) regulations in order to of gestation, calculated from the date the Unfunded Mandates implement sec. 402 of the Veterans’ last normal menstrual period began to The Unfunded Mandates Reform Act Benefits Improvement Act of 2008. the date of expulsion, extraction, or of 1995 requires, at 2 U.S.C. 1532, that Section 402 of the Veterans’ Benefits delivery. Our definition of the term agencies prepare an assessment of Improvement Act of 2008 extended excludes a fetus or child extracted for anticipated costs and benefits before SGLI dependent coverage to an insured purposes of an abortion. issuing any rule that may result in an member’s stillborn child. This final rule Our definition is consistent with expenditure by State, local, and tribal defines the term ‘‘member’s stillborn Congressional intent that VA issue governments, in the aggregate, or by the child.’’ regulations that define the term private sector, of $100 million or more DATES: Effective Date: November 18, ‘‘stillborn child’’ consistently with the (adjusted annually for inflation) in any 2009. 1992 recommended reporting one year. This rule would have no such Applicability Date: VA will apply this requirements of the Model State Vital effect on State, local, and tribal rule to deaths occurring on or after Statistics Act and Regulations (Model governments, or the private sector. Act) as drafted by the Centers for October 10, 2008, the date of enactment Paperwork Reduction Act of the Veterans’ Benefits Improvement Disease Control and Prevention’s Act of 2008. National Center for Health Statistics. S. This final rule contains no provisions Rep. No. 110–449, at 41 (2008); Joint constituting a collection of information FOR FURTHER INFORMATION CONTACT: Greg under the Paperwork Reduction Act (44 Hosmer, Senior Attorney-Advisor, Explanatory Statement on Amendment U.S.C. 3501 et seq.). Department of Veterans Affairs Regional to Senate Bill, S. 3023, as Amended, 154 Office and Insurance Center (310/290B), Cong. Rec. S10,445, S10,452 (daily ed. Executive Order 12866 Oct. 2, 2008). Congress did not intend P.O. Box 8079, Philadelphia, the term ‘‘stillborn child’’ to cover the Executive Order 12866 directs Pennsylvania 19101, (215) 842–2000, deaths of fetuses or children at any agencies to assess all costs and benefits ext 4280. (This is not a toll free gestational age or under every of available regulatory alternatives and, number.) circumstance. S. Rep. No. 110–449, at when regulation is necessary, to select SUPPLEMENTARY INFORMATION: The 41. The Model Act recommends a state regulatory approaches that maximize Veterans’ Survivor Benefits reporting requirement of fetal deaths net benefits (including potential Improvements Act of 2001, Public Law involving fetuses weighing 350 grams or economic, environmental, public health 107–14, established a program of family more, or if weight is unknown, of 20 and safety, and other advantages; insurance coverage under completed weeks or more of gestation, distributive impacts; and equity). The Servicemembers’ Group Life Insurance calculated from the date the last normal Executive Order classifies as a (SGLI) through which the dependents of menstrual period began to the date of ‘‘significant regulatory action,’’ SGLI-insured service members could delivery. Model Act section 15. The requiring review by the Office of also be insured. Section 4 of Public Law Model Act defines ‘‘fetal death’’ to mean Management and Budget (OMB) unless 107–14 amended section 1965 of title ‘‘death prior to the complete expulsion OMB waives such review, any 38, United States Code (U.S.C.), which or extraction from its mother of a regulatory action that is likely to result defines various terms for SGLI purposes, product of human conception, in a rule that may: (1) Have an annual to define the term ‘‘insurable irrespective of the duration of effect on the economy of $100 million dependent’’ as a member’s spouse or a pregnancy and which is not an induced or more, or adversely affect in a material member’s child (as defined in 38 U.S.C. termination of pregnancy. The death is way the economy, a sector of the 101(4)(A)). Section 101(4)(A) defines the indicated by the fact that[,] after such economy, productivity, competition, term ‘‘child’’ in part as an unmarried expulsion or extraction, the fetus does jobs, the environment, public health or person who: (1) Is under the age of 18 not breathe or show any other evidence safety, or State, local, or tribal years; (2) became permanently of life, such as beating of the heart, governments or communities; (2) create incapable of self support before pulsation of the umbilical cord, or a serious inconsistency or otherwise attaining the age of 18; or (3) after definite movement of voluntary interfere with an action taken or
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planned by another agency; (3) (B) Ff fetal weight is unknown, specifications for groundfish in the GOA materially alter the budgetary impact of duration in utero is 20 completed weeks (74 FR 7333, February 17, 2009). Under entitlements, grants, user fees, or loan of gestation or more, calculated from the § 679.81(c)(1), 170 mt of halibut PSC is programs or the rights and obligations of date the last normal menstrual period allocated to catcher/processor and recipients thereof; or (4) raise novel began to the date of expulsion, catcher vessel rockfish cooperatives in legal or policy issues arising out of legal extraction, or delivery. the Central GOA. The website at http:// mandates, the President’s priorities, or (2) The term does not include any www.alaskafisheries.noaa.gov/ the principles set forth in the Executive fetus or child extracted for purposes of sustainablefisheries/goarat/ Order. an abortion. 09rppallocations.xls lists this amount. VA has examined the interagency, * * * * * The remaining 1,830 mt of halibut PSC economic, legal, and policy implications [FR Doc. E9–27644 Filed 11–17–09; 8:45 am] is allocated to vessels using trawl gear of this final rule and has determined BILLING CODE 8320–01–P not in a rockfish cooperative. that it is not a significant regulatory As of November 9, 2009, the action under the Executive Order Administrator, Alaska Region, NMFS because it merely interprets existing law DEPARTMENT OF COMMERCE (Regional Administrator), has and does not raise any novel legal or determined that rockfish cooperatives in policy issues and will have little to no National Oceanic and Atmospheric the Central GOA have not used 139 mt effect on the economy. Administration of the allocation. Therefore, in Regulatory Flexibility Act accordance with § 679.21(d)(5)(iii)(B)(1), NMFS is reallocating 139 mt of halibut The Secretary hereby certifies that 50 CFR Part 679 PSC from rockfish cooperatives in the this final rule will not have a significant [Docket No. 09100091344–9056–02] economic impact on a substantial Central GOA to the last seasonal number of small entities as they are RIN 0648–XS89 apportionment for vessels using trawl gear in the GOA. defined in the Regulatory Flexibility Fisheries of the Exclusive Economic Act, 5 U.S.C. 601 et seq. This final rule Therefore, the harvest specifications Zone Off Alaska; Reallocation of for halibut PSC are revised as follows: will directly affect only individuals and Halibut in the Gulf of Alaska will not directly affect small entities. 31 mt to rockfish cooperatives in the Therefore, pursuant to 5 U.S.C. 605(b), AGENCY: National Marine Fisheries Central GOA and 1,969 mt to vessels this final rule is exempt from the initial Service (NMFS), National Oceanic and using trawl gear. and final regulatory flexibility analysis Atmospheric Administration (NOAA), Classification requirements of sections 603 and 604. Commerce. This action responds to the best ACTION: Temporary rule; reallocation. Catalog of Federal Domestic Assistance available information recently obtained The catalog of Federal Domestic SUMMARY: NMFS is reallocating the from the fishery. The Assistant Assistance Program number and the title projected unused amount of halibut Administrator for Fisheries, NOAA for this regulation is 64.103, Life prohibited species catch (PSC) from (AA), finds good cause to waive the Insurance for Veterans. rockfish cooperatives in the Central Gulf requirement to provide prior notice and opportunity for public comment List of Subjects in 38 CFR Part 9 of Alaska (GOA) Rockfish Pilot Program to vessels using trawl gear in the GOA. pursuant to the authority set forth at 5 Life insurance, Military personnel, This action is necessary to provide the U.S.C. 553(b)(B) as such requirement is Veterans. opportunity to vessels using trawl gear impracticable and contrary to the public Approved: October 6, 2009. to harvest available GOA groundfish interest. This requirement is John R. Gingrich, total allowable catch (TAC) under impracticable and contrary to the public Chief of Staff, Department of Veterans Affairs. existing PSC limits. interest as it would prevent NMFS from responding to the most recent fisheries ■ For the reasons stated in the preamble, DATES: Effective 1200 hrs, Alaska local time (A.l.t.), November 15, 2009, data in a timely fashion and would the Department of Veterans Affairs is delay the reallocation of projected amending 38 CFR part 9 as follows: through 2400 hrs, A.l.t., December 31, 2009. unused amounts of halibut PSC in the PART 9—SERVICEMEMBERS’ GROUP GOA. NMFS was unable to publish a FOR FURTHER INFORMATION CONTACT: LIFE INSURANCE AND VETERANS’ notice providing time for public Steve Whitney, 907–586–7269. GROUP LIFE INSURANCE comment because the most recent, SUPPLEMENTARY INFORMATION: NMFS relevant data only became available as ■ 1. The authority citation for part 9 is manages the groundfish fishery in the of November 9, 2009. revised to read as follows: GOA according to the Fishery The AA also finds good cause to Authority: 38 U.S.C. 501, 1965–1980A, Management Plan for Groundfish of the waive the 30-day delay in the effective unless otherwise noted. Gulf of Alaska (FMP) prepared by the date of this action under 5 U.S.C. North Pacific Fishery Management 553(d)(3). This finding is based upon ■ 2. Section 9.1 is amended by adding Council under authority of the the reasons provided above for waiver of paragraph (k) to read as follows: Magnuson-Stevens Fishery prior notice and opportunity for public § 9.1 Definitions. Conservation and Management Act. comment. * * * * * Regulations governing fishing by U.S. Authority: 16 U.S.C. 1801 et seq. (k)(1) The term member’s stillborn vessels in accordance with the FMP Dated: November 12, 2009 child means a member’s natural child— appear at subpart H of 50 CFR part 600 (i) Whose death occurs before and 50 CFR part 679. Emily H. Menashes, expulsion, extraction, or delivery; and The 2009 allocation of halibut PSC to Acting Director, Office of Sustainable (ii) Whose— vessels using trawl gear in the GOA is Fisheries, National Marine Fisheries Service. (A) Fetal weight is 350 grams or more; 2,000 metric tons (mt) as established by [FR Doc. E9–27668 Filed 11–13–09; 4:15 pm] or the final 2009 and 2010 harvest BILLING CODE 3510–22–S
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Proposed Rules Federal Register Vol. 74, No. 221
Wednesday, November 18, 2009
This section of the FEDERAL REGISTER • Federal eRulemaking Portal: Go to FAA–2009–1068; Directorate Identifier contains notices to the public of the proposed http://www.regulations.gov. Follow the 2009–NM–042–AD’’ at the beginning of issuance of rules and regulations. The instructions for submitting comments. your comments. We specifically invite purpose of these notices is to give interested • Fax: (202) 493–2251. comments on the overall regulatory, persons an opportunity to participate in the • Mail: U.S. Department of economic, environmental, and energy rule making prior to the adoption of the final rules. Transportation, Docket Operations, M– aspects of this proposed AD. We will 30, West Building Ground Floor, Room consider all comments received by the W12–140, 1200 New Jersey Avenue, SE., closing date and may amend this DEPARTMENT OF TRANSPORTATION Washington, DC 20590. proposed AD based on those comments. • Hand Delivery: U.S. Department of We have lengthened the 30-day Federal Aviation Administration Transportation, Docket Operations, M– comment period for proposed ADs that 30, West Building Ground Floor, Room address MCAI originated by aviation 14 CFR Part 39 W12–40, 1200 New Jersey Avenue, SE., authorities of other countries to provide Washington, DC, between 9 a.m. and 5 adequate time for interested parties to [Docket No. FAA–2009–1068; Directorate p.m., Monday through Friday, except submit comments. The comment period Identifier 2009–NM–042–AD] Federal holidays. for these proposed ADs is now typically For service information identified in 45 days, which is consistent with the RIN 2120–AA64 this proposed AD, contact Bombardier, comment period for domestic transport Inc., 400 Coˆte-Vertu Road West, Dorval, ADs. Airworthiness Directives; Bombardier Que´bec H4S 1Y9, Canada; telephone We will post all comments we Model CL–600–2B19 (Regional Jet 514–855–5000; fax 514–855–7401; receive, without change, to http:// Series 100 & 440) Airplanes e-mail [email protected]; www.regulations.gov, including any Internet http://www.bombardier.com. AGENCY: personal information you provide. We Federal Aviation You may review copies of the Administration (FAA), DOT. will also post a report summarizing each referenced service information at the substantive verbal contact we receive ACTION: Notice of proposed rulemaking FAA, Transport Airplane Directorate, about this proposed AD. (NPRM). 1601 Lind Avenue, SW., Renton, Washington. For information on the Discussion SUMMARY: We propose to adopt a new availability of this material at the FAA, airworthiness directive (AD) for the On February 5, 2009, we issued AD call 425–227–1221 or 425–227–1152. products listed above that would 2009–04–11, Amendment 39–15817 (74 supersede an existing AD. This Examining the AD Docket FR 7789, February 20, 2009). That AD proposed AD results from mandatory required actions intended to address an You may examine the AD docket on unsafe condition on the products listed continuing airworthiness information the Internet at http:// (MCAI) originated by an aviation above. www.regulations.gov; or in person at the Note 1 of AD 2009–04–11 stated that authority of another country to identify Docket Operations office between 9 a.m. and correct an unsafe condition on an we were differing from Canadian and 5 p.m., Monday through Friday, Airworthiness Directive CF–2008–35, aviation product. The MCAI describes except Federal holidays. The AD docket the unsafe condition as: dated December 22, 2008, by not contains this proposed AD, the including or requiring certain actions The heating capability of several Angle Of regulatory evaluation, any comments that have planned compliance times Attack (AOA) transducer heating elements received, and other information. The that would allow enough time to removed from in-service aircraft have been street address for the Docket Operations provide notice and opportunity for prior found to be below the minimum requirement. office (telephone (800) 647–5527) is in Also, it was discovered that a large number public comment on the merits of those the ADDRESSES section. Comments will of AOA transducers repaired in an approved actions. We were considering further maintenance facility were not calibrated be available in the AD docket shortly rulemaking at that time to address the accurately. after receipt. unsafe condition. Since then, we have Inaccurate calibration of the AOA FOR FURTHER INFORMATION CONTACT: determined that further rulemaking is transducer and/or degraded AOA transducer Wing Chan, Aerospace Engineer, necessary and are proposing to mandate heating elements can result in early or late Systems and Flight Test Branch, ANE– a one-time inspection of certain angle of activation of the stall warning, stick shaker 172, FAA, New York Aircraft attack (AOA) transducers, replacement and stick pusher by the Stall Protection Certification Office, 1600 Stewart Computer (SPC). of transducers having certain serial Avenue, Suite 410, Westbury, New York numbers, repetitive inspections of the * * * * * 11590; telephone (516) 228–7311; fax inrush current for certain AOA The unsafe condition is reduced (516) 794–5531. transducers, and replacement of controllability of the airplane. The SUPPLEMENTARY INFORMATION: inaccurately calibrated AOA proposed AD would require actions that transducers. are intended to address the unsafe Comments Invited condition described in the MCAI. We invite you to send any written Relevant Service Information DATES: We must receive comments on relevant data, views, or arguments about Bombardier has issued Service this proposed AD by January 4, 2010. this proposed AD. Send your comments Bulletin 601R–27–154, dated December ADDRESSES: You may send comments by to an address listed under the 1, 2008. The actions described in this any of the following methods: ADDRESSES section. Include ‘‘Docket No. service information are intended to
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correct the unsafe condition identified detail the scope of the Agency’s Bombardier, Inc. (Formerly Canadair): in the MCAI. authority. Docket No. FAA–2009–1068; Directorate We are issuing this rulemaking under Identifier 2009–NM–042–AD. FAA’s Determination and Requirements the authority described in ‘‘Subtitle VII, of This Proposed AD Comments Due Date Part A, Subpart III, Section 44701: (a) We must receive comments by January This product has been approved by General requirements.’’ Under that 4, 2010. the aviation authority of another section, Congress charges the FAA with country, and is approved for operation promoting safe flight of civil aircraft in Affected ADs in the United States. Pursuant to our air commerce by prescribing regulations (b) The proposed AD supersedes AD 2009– bilateral agreement with the State of for practices, methods, and procedures 04–11, Amendment 39–15817. Design Authority, we have been notified the Administrator finds necessary for Applicability of the unsafe condition described in the safety in air commerce. This regulation (c) This AD applies to Bombardier Model MCAI and service information is within the scope of that authority CL–600–2B19 (Regional Jet Series 100 & 440) referenced above. We are proposing this because it addresses an unsafe condition airplanes, serial numbers 7003 and AD because we evaluated all pertinent that is likely to exist or develop on subsequent, certificated in any category, that information and determined an unsafe products identified in this rulemaking are equipped with Thales angle of attack condition exists and is likely to exist or action. (AOA) transducers having part number (P/N) develop on other products of the same 45150340 or C16258AA. Regulatory Findings type design. Subject We determined that this proposed AD Differences Between This AD and the (d) Air Transport Association (ATA) of MCAI or Service Information would not have federalism implications America Code 27: Flight controls. under Executive Order 13132. This We have reviewed the MCAI and proposed AD would not have a Reason related service information and, in substantial direct effect on the States, on (e) The mandatory continued airworthiness general, agree with their substance. But the relationship between the national information (MCAI) states: we might have found it necessary to use Government and the States, or on the The heating capability of several Angle Of different words from those in the MCAI distribution of power and Attack (AOA) transducer heating elements to ensure the AD is clear for U.S. responsibilities among the various removed from in-service aircraft have been operators and is enforceable. In making levels of government. found to be below the minimum requirement. Also, it was discovered that a large number these changes, we do not intend to differ For the reasons discussed above, I substantively from the information of AOA transducers repaired in an approved certify this proposed regulation: maintenance facility were not calibrated provided in the MCAI and related 1. Is not a ‘‘significant regulatory accurately. service information. action’’ under Executive Order 12866; Inaccurate calibration of the AOA We might also have proposed 2. Is not a ‘‘significant rule’’ under the transducer and/or degraded AOA transducer different actions in this AD from those DOT Regulatory Policies and Procedures heating elements can result in early or late in the MCAI in order to follow FAA (44 FR 11034, February 26, 1979); and activation of the stall warning, stick shaker policies. Any such differences are 3. Will not have a significant and stick pusher by the Stall Protection highlighted in a NOTE within the economic impact, positive or negative, Computer (SPC). proposed AD. This [Canadian] directive mandates a on a substantial number of small entities periodic inspection of the inrush current to Costs of Compliance under the criteria of the Regulatory verify the AOA heating capability and Flexibility Act. replacement of the inaccurately calibrated Based on the service information, we We prepared a regulatory evaluation estimate that this proposed AD would AOA transducers. of the estimated costs to comply with The unsafe condition is reduced affect about 613 products of U.S. this proposed AD and placed it in the registry. controllability of the airplane. The required AD docket. actions also include a one-time inspection for The actions that are required by AD certain AOA transducers and replacement of 2009–04–11 and retained in this List of Subjects in 14 CFR Part 39 transducers having certain serial numbers. proposed AD take about 1 work-hour Air transportation, Aircraft, Aviation per product, at an average labor rate of Restatement of Requirements of AD 2009– safety, Incorporation by reference, 04–11, With No Changes $80 per work hour. Based on these Safety. figures, the estimated cost of the (f) Unless already done, do the following currently required actions is $80 per The Proposed Amendment actions: (1) For airplanes equipped with a product. Accordingly, under the authority We estimate that it would take about transducer having accumulated more than delegated to me by the Administrator, 7,500 total flight hours as of March 9, 2009 1 work-hour per product to comply with the FAA proposes to amend 14 CFR part (the effective date of AD 2009–04–11): the new basic requirements of this 39 as follows: Within 250 flight hours after March 9, 2009, proposed AD. The average labor rate is measure the inrush current of both AOA $80 per work-hour. Based on these PART 39—AIRWORTHINESS transducers in accordance with Part A of the figures, we estimate the cost of the DIRECTIVES Accomplishment Instructions of Bombardier proposed AD on U.S. operators to be Service Bulletin 601R–27–153, Revision A, $49,040, or $80 per product. 1. The authority citation for part 39 dated December 16, 2008. continues to read as follows: (i) If both AOA transducers are found to Authority for This Rulemaking have an inrush current of 1.60 amps or more, Authority: 49 U.S.C. 106(g), 40113, 44701. Title 49 of the United States Code repeat the measurement thereafter at § 39.13 [Amended] intervals not to exceed the applicable interval specifies the FAA’s authority to issue specified in Table 1 of this AD. Do the rules on aviation safety. Subtitle I, 2. The FAA amends § 39.13 by measurement in accordance with Part A of section 106, describes the authority of removing Amendment 39–15817 (74 FR the Accomplishment Instructions of the FAA Administrator. ‘‘Subtitle VII: 7789, February 20, 2009) and adding the Bombardier Service Bulletin 601R–27–153, Aviation Programs,’’ describes in more following new AD: Revision A, dated December 16, 2008.
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TABLE 1—REPETITIVE MEASUREMENT INTERVALS
If the last inrush current measurement of the serviceable AOA transducer is— Then repeat the measurement—
More than or equal to 1.90 amps ...... Within 2,000 flight hours after the last measurement. More than or equal to 1.80 amps but less than 1.90 amps ...... Within 1,500 flight hours after the last measurement. More than or equal to 1.70 amps but less than 1.80 amps ...... Within 1,000 flight hours after the last measurement. More than or equal to 1.60 amps but less than 1.70 amps ...... Within 500 flight hours after the last measurement.
(ii) If one AOA transducer is found to have (B) Within 1,000 flight hours after the corresponding requirements of paragraphs an inrush current below 1.60 amps, and the measurement required by paragraph (f) of (f)(1) and (f)(2) of this AD. other AOA transducer is found to have an this AD, replace both degraded AOA inrush current of 1.60 amps or more: Do the transducers with new or serviceable New Requirements of This AD: Actions and actions required by paragraphs (f)(1)(ii)(A) transducers in accordance with Part C of the Compliance and (f)(1)(ii)(B) of this AD. Accomplishment Instructions of Bombardier (g) Unless already done, do the following (A) For the AOA transducer having an Service Bulletin 601R–27–153, Revision A, actions. inrush current of 1.60 amps or more: Repeat dated December 16, 2008. Until the (1) For airplanes equipped with a the measurement thereafter at intervals not to replacement is done, dispatch with two transducer having accumulated 7,500 or exceed the applicable interval specified in degraded AOA transducers is allowed, fewer flight hours as of March 9, 2009, except Table 1 of this AD. Do the measurement in provided that the applicable Limitations transducers that have been measured in accordance with Part A of the section of the airplane flight manual (AFM) accordance with paragraph (f)(1) of this AD: Accomplishment Instructions of Bombardier is revised to include the following statement Do the actions specified in paragraph (f)(1) of Service Bulletin 601R–27–153, Revision A, or a copy of this AD is inserted into the this AD before the transducer accumulates dated December 16, 2008. applicable Limitations section of the AFM. 7,500 total flight hours, or within 500 flight (B) For the AOA transducer having an ‘‘Dispatch is allowed if: hours after the effective date of this AD, inrush current below 1.60 amps (‘‘degraded’’ (a) Operations are not conducted in visible whichever occurs later. transducer): Within 1,000 flight hours after moisture (including standing water and (2) Within 900 flight hours after the March 9, 2009, replace that transducer in slush) in any form, effective date of this AD, inspect AOA accordance with Part C of the (b) Operations are not conducted in known transducers having P/N 45150340 or Accomplishment Instructions of Bombardier or forecast icing conditions, C16258AA to determine the serial numbers. Service Bulletin 601R–27–153, Revision A, (c) Both Ice Detection Systems are (i) If the serial number is not identified in dated December 16, 2008. At the applicable operative; and, paragraph 1.A.(1) of Bombardier Service time specified in Table 1 of this AD if the (d) Operations are conducted in day VMC Bulletin 601R–27–154, dated December 1, degraded transducer was replaced with a conditions only.’’ 2008, no further action is required by this serviceable transducer, or within 2,000 flight After the replacement has been paragraph. hours after replacement if the degraded accomplished, the statement or the copy of (ii) If the part number and serial number transducer was replaced with a new this AD may be removed from the AFM. At are identified in one of the tables in transducer, do the measurement for that the applicable time specified in Table 1 of paragraph 1.A.(1) of Bombardier Service replacement transducer and repeat the this AD, if the degraded transducer was Bulletin 601R–27–154, dated December 1, measurements thereafter at intervals not to replaced with a serviceable transducer; or 2008, and have the suffix ‘‘A,’’ no further exceed the applicable interval specified in within 2,000 flight hours after replacement action is required by this paragraph. Table 1 of this AD. Do the measurement in with a new transducer: Do the measurement Note 1: Bombardier Service Bulletin 601R– accordance with Part A of the for that replacement transducer and repeat 27–154, dated December 1, 2008, references Accomplishment Instructions of Bombardier the measurement thereafter at intervals not to Thales Avionics Service Bulletins 45150340– Service Bulletin 601R–27–153, Revision A, exceed the applicable interval specified in 31–004 and C16258A–27–002, both dated dated December 16, 2008. Table 1 of this AD. Do the measurement in November 28, 2008, as additional sources of (iii) If both AOA transducers are found to accordance with Part A of Accomplishment information for part and serial number have an inrush current below 1.60 amps, do Instructions of Bombardier Service Bulletin information. the action specified in paragraph (f)(1)(iii)(A) 601R–27–153, Revision A, dated December (iii) If the part number and serial number or (f)(1)(iii)(B) of this AD. 16, 2008. are identified in a table in paragraph 1.A.(1) (A) Before further flight, replace one of the (2) If, during any repetitive measurement of Bombardier Service Bulletin 601R–27–154, degraded AOA transducers with a new or required by paragraphs (f)(1)(i), (f)(1)(ii), and dated December 1, 2008, before further flight, serviceable transducer; and replace the other (f)(1)(iii) of this AD, any AOA transducer is replace the AOA transducer with a new or degraded transducer with a new or found to have an inrush current below 1.60 serviceable transducer, in accordance with serviceable transducer within 1,000 flight amps, before further flight, replace that the Accomplishment Instructions of hours after the measurement required by transducer in accordance with Part C of the Bombardier Service Bulletin 601R–27–154, paragraph (f)(1) of this AD; in accordance Accomplishment Instructions of Bombardier dated December 1, 2008. with Part C of the Accomplishment Service Bulletin 601R–27–153, Revision A, (3) As of the effective date of this AD, no Instructions of Bombardier Service Bulletin dated December 16, 2008. At the applicable person may install a replacement AOA 601R–27–153, Revision A, dated December time specified in Table 1 of this AD, if the transducer having P/N 45150340 or P/N 16, 2008. At the applicable time specified in degraded transducer was replaced with a C16258AA with a serial number identified in Table 1 of this AD, if the degraded transducer serviceable transducer; or within 2,000 flight paragraph 1.A.(1) of Bombardier Service was replaced with a serviceable transducer; hours after replacement if the degraded Bulletin 601R–27–154, dated December 1, or within 2,000 flight hours after replacement transducer was replaced with a new 2008, unless the serial number has the suffix if the degraded transducer was replaced with transducer: Do the measurement for that ‘‘A.’’ a new transducer: Do the measurement for replacement transducer as specified in FAA AD Differences that replacement transducer and repeat the paragraph (f)(1)(ii)(B) of this AD and repeat measurement thereafter at intervals not to the measurement thereafter at intervals not to Note 2: This AD differs from the MCAI exceed the applicable interval specified in exceed the applicable interval specified in and/or service information as follows: No Table 1 of this AD. Do the measurements in Table 1 of this AD. Differences. accordance with Part A of the (3) Actions done before March 9, 2009, in Accomplishment Instructions of Bombardier accordance with Bombardier Service Bulletin Other FAA AD Provisions Service Bulletin 601R–27–153, Revision A, 601R–27–153, dated October 17, 2008, are (h) The following provisions also apply to dated December 16, 2008. acceptable for compliance with the this AD:
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(1) Alternative Methods of Compliance ACTION: Notice of proposed rulemaking Examining the AD Docket (AMOCs): The Manager, New York Aircraft (NPRM). Certification Office (ACO), ANE–170, FAA, You may examine the AD docket on the Internet at http:// has the authority to approve AMOCs for this SUMMARY: We propose to adopt a new www.regulations.gov; or in person at the AD, if requested using the procedures found airworthiness directive (AD) for the Docket Operations office between 9 a.m. in 14 CFR 39.19. Send information to ATTN: products listed above that would Program Manager, Continuing Operational and 5 p.m., Monday through Friday, supersede an existing AD. This Safety, FAA, New York ACO, 1600 Stewart except Federal holidays. The AD docket proposed AD results from mandatory Avenue, Suite 410, Westbury, New York contains this proposed AD, the continuing airworthiness information 11590; telephone (516) 228–7300; fax (516) regulatory evaluation, any comments (MCAI) originated by an aviation 794–5531. Before using any approved AMOC received, and other information. The on any airplane to which the AMOC applies, authority of another country to identify street address for the Docket Operations notify your principal maintenance inspector and correct an unsafe condition on an office (telephone (800) 647–5527) is in (PMI) or principal avionics inspector (PAI), aviation product. The MCAI describes the ADDRESSES section. Comments will as appropriate, or lacking a principal the unsafe condition as: inspector, your local Flight Standards District be available in the AD docket shortly Office. The AMOC approval letter must Following the occurrence of cracks on the after receipt. MLG [main landing gear] rib 5 RH [right- specifically reference this AD. FOR FURTHER INFORMATION CONTACT: Dan hand] and LH [left-hand] attachment fitting (2) Airworthy Product: For any requirement Rodina, Aerospace Engineer, in this AD to obtain corrective actions from lower flanges, DGAC [Direction Ge´ne´rale de a manufacturer or other source, use these l’Aviation Civile] France AD 2003–318(B) International Branch, ANM–116, actions if they are FAA-approved. Corrective [parallel to part of FAA AD 2006–12–13] was Transport Airplane Directorate, FAA, actions are considered FAA-approved if they issued to require repetitive inspections and, 1601 Lind Avenue, SW., Renton, are approved by the State of Design Authority as terminating action * * *[.] Washington 98057–3356; telephone (or their delegated agent). You are required Subsequently, new cases of cracks were (425) 227–2125; fax (425) 227–1149. discovered during scheduled maintenance to assure the product is airworthy before it SUPPLEMENTARY INFORMATION: is returned to service. checks by operators of A300B4 and A300– (3) Reporting Requirements: For any 600 type aeroplanes on which the Comments Invited terminating action * * * [was] embodied. reporting requirement in this AD, under the We invite you to send any written provisions of the Paperwork Reduction Act This condition, if not corrected, could affect (44 U.S.C. 3501 et seq.), the Office of the structural integrity of those aeroplanes. relevant data, views, or arguments about Management and Budget (OMB) has * * * * * this proposed AD. Send your comments to an address listed under the approved the information collection The proposed AD would require actions ADDRESSES section. Include ‘‘Docket No. requirements and has assigned OMB Control that are intended to address the unsafe Number 2120–0056. FAA–2009–1067; Directorate Identifier condition described in the MCAI. Related Information 2009–NM–071–AD’’ at the beginning of DATES: We must receive comments on your comments. We specifically invite (i) Refer to MCAI Canadian Airworthiness this proposed AD by January 4, 2010. comments on the overall regulatory, Directive CF–2008–35, dated December 22, 2008; Bombardier Service Bulletin 601R–27– ADDRESSES: You may send comments by economic, environmental, and energy 154, dated December 1, 2008; and any of the following methods: aspects of this proposed AD. We will Bombardier Service Bulletin 601R–27–153, • Federal eRulemaking Portal: Go to consider all comments received by the Revision A, dated December 16, 2008; for http://www.regulations.gov. Follow the closing date and may amend this related information. instructions for submitting comments. proposed AD based on those comments. Issued in Renton, Washington, on • Fax: (202) 493–2251. We have lengthened the 30-day comment period for proposed ADs that November 6, 2009. • Mail: U.S. Department of address MCAI originated by aviation Ali Bahrami, Transportation, Docket Operations, M– authorities of other countries to provide Manager, Transport Airplane Directorate, 30, West Building Ground Floor, Room adequate time for interested parties to Aircraft Certification Service. W12–140, 1200 New Jersey Avenue, SE., submit comments. The comment period [FR Doc. E9–27625 Filed 11–17–09; 8:45 am] Washington, DC 20590. • for these proposed ADs is now typically BILLING CODE 4910–13–P Hand Delivery: U.S. Department of 45 days, which is consistent with the Transportation, Docket Operations, M– comment period for domestic transport 30, West Building Ground Floor, Room DEPARTMENT OF TRANSPORTATION ADs. W12–40, 1200 New Jersey Avenue, SE., We will post all comments we Washington, DC, between 9 a.m. and 5 Federal Aviation Administration receive, without change, to http:// p.m., Monday through Friday, except www.regulations.gov, including any Federal holidays. 14 CFR Part 39 personal information you provide. We For service information identified in will also post a report summarizing each this proposed AD, contact Airbus SAS— substantive verbal contact we receive [Docket No. FAA–2009–1067; Directorate EAW (Airworthiness Office), 1 Rond Identifier 2009–NM–071–AD] about this proposed AD. Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 Discussion RIN 2120–AA64 96; fax +33 5 61 93 44 51; e-mail: On May 31, 2006, we issued AD Airworthiness Directives; Airbus Model [email protected]; 2006–12–13, Amendment 39–14639 (71 A300 B2 and A300 B4 Series Airplanes; Internet http://www.airbus.com. You FR 33994, June 13, 2006). That AD A300 B4–600, B4–600R, and F4–600R may review copies of the referenced required actions intended to address an Series Airplanes; and Model C4–605R service information at the FAA, unsafe condition on the products listed Variant F Airplanes (Collectively Called Transport Airplane Directorate, 1601 above. A300–600 Series Airplanes) Lind Avenue, SW., Renton, Washington. Since we issued AD 2006–12–13, the For information on the availability of European Aviation Safety Agency AGENCY: Federal Aviation this material at the FAA, call 425–227– (EASA), which is the Technical Agent Administration (FAA), DOT. 1221 or 425–227–1152. for the Member States of the European
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Community, has issued EASA proposed AD, as listed in the following Costs of Compliance Airworthiness Directive 2009–0081, table: Based on the service information, we dated April 6, 2009 (referred to after this estimate that this proposed AD would as ‘‘the MCAI’’), to correct an unsafe REVISED PARAGRAPH IDENTIFIERS affect about 155 products of U.S. condition for the specified products. registry. The MCAI states: Corresponding Requirement in requirement in The actions that are required by AD Following the occurrence of cracks on the AD 2006–12–13 this proposed 2006–12–13 and retained in this MLG [main landing gear] rib 5 RH [right- AD proposed AD take about 76 work-hours hand] and LH [left-hand] attachment fitting per product, at an average labor rate of Paragraph (e) ...... paragraph (f). lower flanges, DGAC [Direction Ge´ne´rale de $80 per work hour. Required parts cost l’Aviation Civile] France AD 2003–318(B) Paragraph (f) ...... paragraph (g). [parallel to part of FAA AD 2006–12–13] was Paragraph (g) ...... paragraph (h). about $10,270 per product. Based on issued to require repetitive inspections and, Paragraph (h) ...... paragraph (i). these figures, the estimated cost of the as terminating action, the embodiment of Paragraph (i) ...... paragraph (j). currently required actions is $16,350 per Airbus Service Bulletins (SB) A300–57–0235 Paragraph (j) ...... paragraph (k). product. and A300–57–6088 * * *. Paragraph (k) ...... paragraph (l). We estimate that it would take about Subsequently, new cases of cracks were Paragraph (l) ...... paragraph (m). 3 work-hours per product to comply discovered during scheduled maintenance with the new basic requirements of this checks by operators of A300B4 and A300– We have also revised paragraph (i) of proposed AD. The average labor rate is 600 type aeroplanes on which the this NPRM to clarify the compliance $80 per work-hour. Based on these terminating action SBs were embodied. This times for airplanes that have not had the figures, we estimate the cost of the condition, if not corrected, could affect the modification required by paragraph (i) structural integrity of those aeroplanes. proposed AD on U.S. operators to be of this NPRM accomplished before July $37,200, or $240 per product. To address and correct this condition, 18, 2006. We added the phrase, ‘‘Except Airbus developed an inspection programme as required by paragraph (l) of this AD,’’ Authority for This Rulemaking for aeroplanes modified in accordance with SB A300–57–0235 or A300–57–6088. This to paragraph (i) of this NPRM. We have Title 49 of the United States Code inspection programme was required to be determined that this change will neither specifies the FAA’s authority to issue implemented by DGAC France AD F–2005– increase the economic burden on any rules on aviation safety. Subtitle I, 113, original issue and later revision 1 operator nor increase the scope of the section 106, describes the authority of [parallel to part of FAA AD 2006–12–13]. AD. the FAA Administrator. ‘‘Subtitle VII: A new EASA AD 2008–0111, superseding We have also revised paragraph (o) of Aviation Programs,’’ describes in more DGAC France AD F–2005–113R1, was issued this AD to specify that no reporting is detail the scope of the Agency’s to reduce the applicability. For aeroplanes required. already compliant with DGAC France AD F– authority. 2005–113R1, no further action was required. FAA’s Determination and Requirements We are issuing this rulemaking under Since EASA AD 2008–0111 issuance, of This Proposed AD the authority described in ‘‘Subtitle VII, Airbus reviewed the inspection programmes This product has been approved by Part A, Subpart III, Section 44701: of SB A300–57A0246 and SB A300–57A6101 the aviation authority of another General requirements.’’ Under that to introduce repetitive inspections including country, and is approved for operation section, Congress charges the FAA with a new inspection technique for holes 47 and promoting safe flight of civil aircraft in 54 and to reduce inspections threshold and in the United States. Pursuant to our intervals from 700 Flight Cycles (FC) to 400 bilateral agreement with the State of air commerce by prescribing regulations FC until a revised terminating action is made Design Authority, we have been notified for practices, methods, and procedures available. of the unsafe condition described in the the Administrator finds necessary for MCAI and service information safety in air commerce. This regulation Required actions include contacting referenced above. We are proposing this is within the scope of that authority Airbus for repair instructions, if AD because we evaluated all pertinent because it addresses an unsafe condition necessary, and doing the repair. You information and determined an unsafe that is likely to exist or develop on may obtain further information by condition exists and is likely to exist or products identified in this rulemaking examining the MCAI in the AD docket. develop on other products of the same action. Relevant Service Information type design. Regulatory Findings Airbus has issued Mandatory Service Differences Between This AD and the We determined that this proposed AD Bulletin A300–57A0246, including MCAI or Service Information would not have federalism implications Appendixes 1 and 2, Revision 03, dated We have reviewed the MCAI and under Executive Order 13132. This March 11, 2009; and Mandatory Service related service information and, in proposed AD would not have a Bulletin A300–57A6101, including general, agree with their substance. But substantial direct effect on the States, on Appendixes 1 and 2, Revision 03, dated we might have found it necessary to use the relationship between the national March 11, 2009. The actions described different words from those in the MCAI Government and the States, or on the in this service information are intended to ensure the AD is clear for U.S. distribution of power and to correct the unsafe condition operators and is enforceable. In making responsibilities among the various identified in the MCAI. these changes, we do not intend to differ levels of government. Changes to Existing AD substantively from the information For the reasons discussed above, I provided in the MCAI and related certify this proposed regulation: This proposed AD would retain service information. 1. Is not a ‘‘significant regulatory certain requirements of AD 2006–12–13. We might also have proposed action’’ under Executive Order 12866; Since AD 2006–12–13 was issued, the different actions in this AD from those 2. Is not a ‘‘significant rule’’ under the AD format has been revised, and certain in the MCAI in order to follow FAA DOT Regulatory Policies and Procedures paragraphs have been rearranged. As a policies. Any such differences are (44 FR 11034, February 26, 1979); and result, the corresponding paragraph highlighted in a NOTE within the 3. Will not have a significant identifiers have changed in this proposed AD. economic impact, positive or negative,
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on a substantial number of small entities Applicability A new EASA [European Aviation Safety under the criteria of the Regulatory (c) This AD applies to the airplanes, Agency] AD 2008–0111, superseding DGAC Flexibility Act. certificated in any category, identified in France AD F–2005–113R1, was issued to We prepared a regulatory evaluation paragraph (c)(1) and (c)(2) of this AD; except reduce the applicability. For aeroplanes already compliant with DGAC France AD F– of the estimated costs to comply with airplanes on which Airbus Modification 11912 or 11932 has been installed. 2005–113R1, no further action was required. this proposed AD and placed it in the (1) Airbus Model A300 B2–1C, B2K–3C, Since EASA AD 2008–0111 issuance, AD docket. B2–203, B4–2C, B4–103, and B4–203 Airbus reviewed the inspection programmes List of Subjects in 14 CFR Part 39 airplanes. of SB A300–57A0246 and SB A300–57A6101 (2) Airbus Model A300 B4–601, B4–603, to introduce repetitive inspections including Air transportation, Aircraft, Aviation B4–620, B4–622, B4–605R, B4–622R, and a new inspection technique for holes 47 and safety, Incorporation by reference, F4–605R airplanes. 54 and to reduce inspections threshold and Safety. Subject intervals from 700 Flight Cycles (FC) to 400 FC until a revised terminating action is made The Proposed Amendment (d) Air Transport Association (ATA) of available. America Code 57: Wings. Accordingly, under the authority Required actions include contacting Airbus Reason for repair instructions, if necessary, and delegated to me by the Administrator, doing the repair. the FAA proposes to amend 14 CFR part (e) The mandatory continuing 39 as follows: airworthiness information (MCAI) states: Restatement of Requirements of AD 2000– Following the occurrence of cracks on the 05–07: MLG [main landing gear] rib 5 RH [right- PART 39—AIRWORTHINESS (f) You are responsible for having the DIRECTIVES hand] and LH [left-hand] attachment fitting lower flanges, DGAC [Direction Ge´ne´rale de actions required by this AD performed within the compliance times specified, unless the 1. The authority citation for part 39 l’Aviation Civile] France AD 2003–318(B) [parallel to part of FAA AD 2006–12–13] was actions have already been done. continues to read as follows: issued to require repetitive inspections and, Repetitive Inspections Authority: 49 U.S.C. 106(g), 40113, 44701. as terminating action, the embodiment of Airbus Service Bulletins (SB) A300–57–0235 (g) Perform a detailed inspection and a § 39.13 [Amended] and A300–57–6088 * * *. high-frequency eddy current (HFEC) Subsequently, new cases of cracks were inspection to detect cracks in Gear Rib 5 of 2. The FAA amends § 39.13 by the main landing gear (MLG) attachment removing Amendment 39–14639 (71 FR discovered during scheduled maintenance checks by operators of A300B4 and A300– fittings at the lower flange, in accordance 33994, June 13, 2006) and adding the 600 type aeroplanes on which the with the Accomplishment Instructions of any following new AD: terminating action SB’s were embodied. This applicable service bulletin listed in Table 1 Airbus: Docket No. FAA–2009–1067; condition, if not corrected, could affect the and Table 2 of this AD, at the time specified Directorate Identifier 2009–NM–071–AD. structural integrity of those aeroplanes. in paragraph (g)(1) or (g)(2) of this AD. After To address and correct this condition, April 12, 2000 (the effective date of AD Comments Due Date Airbus developed an inspection programme 2000–05–07, amendment 39–11616), only the (a) We must receive comments by January for aeroplanes modified in accordance with service bulletins listed in Table 2 of this AD 4, 2010. SB A300–57–0235 or A300–57–6088. This may be used. Repeat the inspections inspection programme was required to be thereafter at intervals not to exceed 1,500 Affected ADs implemented by DGAC France AD F–2005– flight cycles, until the actions specified in (b) The proposed AD supersedes AD 2006– 113, original issue and later revision 1 paragraph (i), (j), or (l) of this AD are 12–13, Amendment 39–14639. [parallel to part of FAA AD 2006–12–13]. accomplished.
TABLE 1—REVISION 01 OF SERVICE BULLETINS
Revision Model— Airbus Service Bulletin— level— Dated—
A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4–622R, F4– A300–57–6087 ...... 01 March 11, 1998. 605R, F4–622R, and A300 C4–605R Variant F airplanes. A300 B2 and A300 B4 series airplanes ...... A300–57–0234 ...... 01 March 11, 1998.
TABLE 2—OTHER REVISIONS OF SERVICE BULLETINS
Model— Airbus Service Bulletin— Revision level— Dated—
A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4– A300–57A6087 ...... 02, including Appendix 01 ... June 24, 1999. 622R, F4–605R, F4–622R, and A300 C4–605R Variant F airplanes. 03, including Appendix 01 ... May 19, 2000. 04, including Appendix 01 ... February 19, 2002. A300 B2 and A300 B4 series airplanes ...... A300–57A0234 ...... 02 ...... June 24, 1999. 03, including Appendix 01 ... September 2, 1999. 04, including Appendix 01 ... May 19, 2000. 05, including Appendix 01 ... February 19, 2002.
(1) For airplanes that have accumulated (2) For airplanes that have accumulated within 1,500 flight cycles after March 9, 20,000 or more total flight cycles as of March less than 20,000 total flight cycles as of 1998, whichever occurs later. 9, 1998 (the effective date of AD 98–03–06, March 9, 1998: Inspect prior to the Note 1: For the purposes of this AD, a amendment 39–10298): Inspect within 500 accumulation of 18,000 total flight cycles, or flight cycles after March 9, 1998. detailed inspection is defined as: ‘‘An
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intensive visual examination of a specific Repair for Any Crack Found During Terminating Modification for Repetitive structural area, system, installation, or Inspections Required by Paragraph (g) of Inspections Required by Paragraphs (g) and assembly to detect damage, failure, or This AD (j) of This AD irregularity. Available lighting is normally (h) If any crack is detected during any (i) Except as required by paragraph (l) of supplemented with a direct source of good inspection required by paragraph (g) of this this AD, prior to the accumulation of 21,000 lighting at intensity deemed appropriate by AD, prior to further flight, accomplish the total flight cycles, or within 2 years after the inspector. Inspection aids such as mirror, requirements of paragraph (h)(1) or (h)(2) of October 20, 1999 (the effective date of AD magnifying lenses, etc., may be used. Surface this AD, as applicable. 99–19–26, amendment 39–11313), whichever (1) If a crack is detected at one hole only, cleaning and elaborate access procedures occurs later: Modify Gear Rib 5 of the MLG and the crack does not extend out of the attachment fittings at the lower flange in may be required.’’ spotface of the hole, repair in accordance accordance with the Accomplishment with the Accomplishment Instructions of the Note 2: Accomplishment of the initial Instructions of the applicable service bulletin detailed and HFEC inspections in accordance applicable service bulletin in Table 2 of this AD. in Table 3 of this AD. After July 18, 2006 (the with Airbus Service Bulletin A300–57A0234 (2) If a crack is detected at more than one effective date of AD 2006–12–13), only or A300–57A6087, both dated August 5, hole, or if any crack at any hole extends out Revision 04 of Airbus Service Bulletin A300– 1997, as applicable, is considered acceptable of the spotface of the hole, repair in 57–6088, and Revisions 04 and 05 of Airbus for compliance with the initial inspections accordance with a method approved by the Service Bulletin A300–57–0235 may be used. required by paragraph (g) of this AD. Manager, International Branch, ANM–116, Accomplishment of this modification Transport Airplane Directorate, FAA, or the constitutes terminating action for the European Aviation Safety Agency (EASA) (or repetitive inspection requirements of its delegated agent). paragraphs (g) and (j) of this AD.
TABLE 3—SERVICE BULLETINS FOR TERMINATING MODIFICATION
Model— Airbus Service Bulletin— Revision level— Dated—
A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4– A300–57–6088 ...... 01, including Appendix 01 ... February 1, 1999. 622R, F4–605R, F4–622R, and A300 C4–605R Variant F airplanes. 02 ...... September 5, 2002 04 ...... December 3, 2003. A300 B2 and A300 B4 series airplanes ...... A300–57–0235 ...... 01, including Appendix 01 ... February 1, 1999. 03 ...... September 5, 2002 04 ...... March 13, 2003. 05 ...... December 3, 2003.
Note 3: Accomplishment of the Restatement of Requirements of AD 2006– the applicable service bulletin listed in Table modification required by paragraph (i) of this 12–13: 4 of this AD. Perform the inspections at the AD prior to April 12, 2000, in accordance Additional Repetitive Inspections applicable time specified in paragraph (j)(1), with Airbus Service Bulletin A300–57–6088 (j)(2), (j)(3), or (j(4) of this AD. Repeat the (j) For airplanes on which the modification or A300–57–0235, both dated August 5, 1998; inspections thereafter at intervals not to specified in paragraph (i) or (l) of this AD has as applicable; is acceptable for compliance not been done before July 18, 2006 (the exceed 700 flight cycles until the terminating with the requirements of that paragraph. effective date of AD 2006–12–13, amendment modification required by paragraph (l) of this 39–14639), perform a detailed and an HFEC AD is accomplished. Accomplishment of the inspection to detect cracks of the lower inspections per paragraph (j) of this AD flange of Gear Rib 5 of the MLG at holes 43, terminates the inspection requirements of 47, 48, 49, 50, 52, and 54, in accordance with paragraph (g) of this AD.
TABLE 4—SERVICE BULLETINS FOR REPETITIVE INSPECTIONS
Model— Airbus Service Bulletin— Revision level— Dated—
A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4– A300–57A6087 ...... 04, including Appendix 01 ... February 19, 2002. 622R, F4–605R, F4–622R, and C4–605R Variant F air- planes. A300 B2–1A, B2–1C, B2K–3C, B2–203, B4–2C, B4–103, A300–57A0234 ...... 05, including Appendix 01 ... February 19, 2002. and B4–203 airplanes.
(1) For Model A300 B2–1A, B2–1C, B2K– accumulation of 18,000 total flight cycles, or flight cycles as of July 18, 2006: Prior to the 3C, B2–203, B4–2C, B4–103, and B4–203 within 700 flight cycles after July 18, 2006, accumulation of 11,600 total flight cycles, or airplanes; Model A300 B4–601, B4–603, B4– whichever occurs later. within 700 flight cycles after July 18, 2006, 620, B4–622, B4–605R, B4–622R, F4–605R, (3) For Model A300 B4–2C, B4–103, and whichever occurs later. F4–622R, and C4–605R Variant F airplanes; B4–203 airplanes that have accumulated less and Model C4–605R Variant F airplanes that than 18,000 total flight cycles as of July 18, Crack Repair have accumulated 18,000 or more total flight 2006: Prior to the accumulation of 14,500 (k) If any crack is detected during any cycles as of July 18, 2006: Within 700 flight total flight cycles, or within 700 flight cycles inspection required by paragraph (j) of this cycles after July 18, 2006. after July 18, 2006, whichever occurs later. AD, prior to further flight, accomplish the (2) For Model A300 B2–1A, B2–1C, B2K– (4) For Model A300 B4–601, B4–603, B4– requirements of paragraphs (k)(1) and (k)(2) 3C, and B2–203 airplanes that have 620, B4–622, B4–605R, B4–622R, F4–605R, of this AD, as applicable. accumulated less than 18,000 total flight F4–622R, and C4–605R Variant F airplanes (1) If a crack is detected at only one hole, cycles as of July 18, 2006: Prior to the that have accumulated less than 18,000 total and the crack does not extend out of the
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spotface of the hole, repair in accordance of the spotface of the hole, repair in Gear Rib 5 of the MLG attachment fittings at with Airbus Service Bulletin A300–57A0234, accordance with a method approved by the the lower flange. Except as provided by Revision 05, including Appendix 01, dated Manager, International Branch, ANM–116, or paragraph (m) of this AD, do the modification February 19, 2002 (for Model A300 B2–1A, the EASA (or its delegated agent). in accordance with the applicable service B2–1C, B2K–3C, B2–203, B4–2C, B4–103, bulletin in Table 5 of this AD. This action and B4–203 airplanes); or A300–57A6087, Terminating Modification for Repetitive terminates the repetitive inspections Revision 04, including Appendix 01, dated Inspections Required by Paragraphs (g) and February 19, 2002 (for Model A300 B4–601, (j) of This AD for Certain Airplanes requirements of paragraphs (g) and (j) of this B4–603, B4–620, B4–622, B4–605R, B4– (l) For airplanes on which the terminating AD. 622R, F4–605R, F4–622R, and C4–605R modification in paragraph (i) of this AD has (1) Prior to the accumulation of 21,000 airplanes); as applicable. not been accomplished before July 18, 2006: total flight cycles, or within 2 years after (2) If a crack is detected at more than one At the earlier of the times specified in October 20, 1999, whichever is later. hole, or if any crack at any hole extends out paragraphs (l)(1) and (l)(2) of this AD, modify (2) Within 16 months after July 18, 2006.
TABLE 5—SERVICE BULLETINS FOR TERMINATING MODIFICATION
Revision Model— Airbus Service Bulletin— level— Dated—
A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4–622R, F4– A300–57–6088 ...... 04 December 3, 2003. 605R, F4–622R, and C4–605R Variant F airplanes. A300 B2–1A, B2–1C, B2K–3C, B2–203, B4–2C, B4–103, and B4– A300–57–0235 ...... 04 March 13, 2003. 203 airplanes. 05 December 3, 2003.
(m) Where the applicable service bulletin in accordance with a method approved by bulletins listed in Table 6 of this AD, are in paragraph (l) of this AD specifies to the Manager, International Branch, ANM– considered acceptable for compliance with contact Airbus for modification instructions; 116, or the EASA (or its delegated agent). the corresponding action specified in or if there is a previously installed repair at Actions Accomplished per Previous Issues of paragraphs (g) through (m) of this AD. any of the affected fastener holes; or if a crack Service Bulletins is found when accomplishing the (n) Actions accomplished before July 18, modification: Prior to further flight, modify 2006, in accordance with the service
TABLE 6—PREVIOUS ISSUES OF SERVICE BULLETINS
Airbus Service Bulletin— Revision level— Dated—
A300–57–0235 ...... 02, including Appendix 01 ...... September 27, 1999. 03 ...... September 5, 2002. A300–57–6088 ...... 02 ...... September 5, 2000. 03 ...... March 13, 2003.
No Reporting (iii) On the outboard side, the lower flange, Mandatory Service Bulletin A300–57A0246, (o) Although the service bulletins the vertical web and around the fastener Revision 03, dated March 11, 2009; or Airbus holes at locations 43, 47 to 50, 52 and 54. Mandatory Service Bulletin A300–57A6101, identified in Tables 1, 2, 3, 4, 5, and 6 of this (2) Do the inspection required by Revision 03, dated March 11, 2009; as AD specify to submit certain information to paragraph (p)(1) of this AD at the later of the applicable. the manufacturer, this AD does not include times in paragraphs (p)(2)(i) and (p)(2)(ii) of (5) If any crack is detected during any of such a requirement. this AD. the inspections required by paragraphs (p)(1), New Requirements of This AD (i) Within 400 flight cycles after the (p)(3), and (p)(4) of this AD, before further accomplishment of the actions required by flight, contact Airbus for a repair solution, (p) Unless already done, do the following paragraph (i) or (l) of this AD, as applicable. and do the repair. actions. (ii) Within 400 flight cycles or 4 months FAA AD Differences (1) At the applicable time specified in after the effective date of this AD, whichever paragraph (p)(2) of this AD, perform a occurs first. Note 4: This AD differs from the MCAI detailed inspection for cracking at the (3) If no cracking is detected during the and/or service information as follows: No locations specified in paragraphs (p)(1)(i), inspection required by paragraph (p)(1) of differences. (p)(1)(ii), and (p)(1)(iii) of this AD, in this AD, before further flight, perform a Other FAA AD Provisions accordance with the Accomplishment fluorescent penetrant inspection (FPI) at Instructions of Airbus Mandatory Service holes location 47 and 54, in the right-hand (q) The following provisions also apply to Bulletin A300–57A0246, Revision 03, dated and left-hand MLG rib 5 attachment fitting this AD: March 11, 2009; or Airbus Mandatory Service lower flange, in accordance with the (1) Alternative Methods of Compliance Accomplishment Instructions of Airbus (AMOCs): The Manager, International Bulletin A300–57A6101, Revision 03, dated Mandatory Service Bulletin A300–57A0246, Branch, FAA, has the authority to approve March 11, 2009, as applicable. Revision 03, dated March 11, 2009; or Airbus AMOCs for this AD, if requested using the (i) The bottom flange and vertical web in Mandatory Service Bulletin A300–57A6101, procedures found in 14 CFR 39.19. Send the area between the wing rear spar/gear rib Revision 03, dated March 11, 2009; as information to ATTN: Dan Rodina, 5 attachment and the forward reaction-rod applicable. Aerospace Engineer, International Branch, pick-up lug. (4) Thereafter, at intervals not to exceed ANM–116, Transport Airplane Directorate, (ii) On the inboard side, around the 400 flight cycles, repeat the detailed and FPI FAA, 1601 Lind Avenue SW., Renton, fastener holes at locations 43, 47 to 50, 52, inspections, in accordance with the Washington 98057–3356; telephone (425) and 54. Accomplishment Instructions of Airbus 227–2125; fax (425) 227–1149. Before using
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any approved AMOC on any airplane to (2) Airworthy Product: For any requirement to assure the product is airworthy before it which the AMOC applies, notify your in this AD to obtain corrective actions from is returned to service. principal maintenance inspector (PMI) or a manufacturer or other source, use these Related Information principal avionics inspector (PAI), as actions if they are FAA-approved. Corrective appropriate, or lacking a principal inspector, actions are considered FAA-approved if they (r) Refer to MCAI EASA Airworthiness your local Flight Standards District Office. Directive 2009–0081, dated April 6, 2009, are approved by the State of Design Authority The AMOC approval letter must specifically and the service information in Table 7 of this reference this AD. (or their delegated agent). You are required AD.
TABLE 7—SERVICE INFORMATION
Airbus Service Information— Revision level— Dated—
Service Bulletin A300–57–0235 ...... 04 ...... March 13, 2003. 05 ...... December 3, 2003. Service Bulletin A300–57–6088 ...... 04 ...... December 3, 2003. Service Bulletin A300–57A0234 ...... 02 ...... June 24, 1999. 03, including Appendix 01 ...... September 2, 1999. 04, including Appendix 01 ...... May 19, 2000. 05, including Appendix 01 ...... February 19, 2002. Service Bulletin A300–57A6087 ...... 02, including Appendix 01 ...... June 24, 1999. 03, including Appendix 01 ...... May 19, 2000. 04, including Appendix 01 ...... February 19, 2002. Mandatory Service Bulletin A300–57A0246 ...... 03 ...... March 11, 2009. Mandatory Service Bulletin A300–57A6101 ...... 03 ...... March 11, 2009
Issued in Renton, Washington, on joint that is modified. This proposed AD Examining the AD Docket November 6, 2009. results from a structural review of You may examine the AD docket on Ali Bahrami, affected skin lap joints for widespread the Internet at http:// Manager, Transport Airplane Directorate, fatigue damage. We are proposing this www.regulations.gov; or in person at the Aircraft Certification Service. AD to prevent fatigue cracking in certain Docket Management Facility between 9 [FR Doc. E9–27631 Filed 11–17–09; 8:45 am] lap joints, which could result in rapid a.m. and 5 p.m., Monday through BILLING CODE 4910–13–P depressurization of the airplane. Friday, except Federal holidays. The AD DATES: We must receive comments on docket contains this proposed AD, the this proposed AD by January 4, 2010. DEPARTMENT OF TRANSPORTATION regulatory evaluation, any comments ADDRESSES: You may send comments by received, and other information. The Federal Aviation Administration any of the following methods: street address for the Docket Office • Federal eRulemaking Portal: Go to (telephone 800–647–5527) is in the 14 CFR Part 39 http://www.regulations.gov. Follow the ADDRESSES section. Comments will be instructions for submitting comments. available in the AD docket shortly after [Docket No. FAA–2009–1066; Directorate • Fax: 202–493–2251. receipt. Identifier 2009–NM–028–AD] • Mail: U.S. Department of FOR FURTHER INFORMATION CONTACT: Ivan RIN 2120–AA64 Transportation, Docket Operations, M– Li, Aerospace Engineer, Airframe 30, West Building Ground Floor, Room Branch, ANM–120S, FAA, Seattle Airworthiness Directives; Boeing W12–140, 1200 New Jersey Avenue, SE., Aircraft Certification Office, 1601 Lind Model 747–100, 747–100B, 747–100B Washington, DC 20590. Avenue, SW., Renton, Washington SUD, 747–200B, 747–300, 747SR, and • Hand Delivery: U.S. Department of 98057–3356; telephone (425) 917–6437; 747SP Series Airplanes Transportation, Docket Operations, M– fax (425) 917–6590. AGENCY: Federal Aviation 30, West Building Ground Floor, Room SUPPLEMENTARY INFORMATION: Administration (FAA), Department of W12–140, 1200 New Jersey Avenue, SE., Comments Invited Transportation (DOT). Washington, DC 20590, between 9 a.m. ACTION: Notice of proposed rulemaking and 5 p.m., Monday through Friday, We invite you to send any written (NPRM). except Federal holidays. relevant data, views, or arguments about For service information identified in this proposed AD. Send your comments SUMMARY: The FAA proposes to this proposed AD, contact Boeing to an address listed under the supersede an existing airworthiness Commercial Airplanes, Attention: Data ADDRESSES section. Include ‘‘Docket No. directive (AD) that applies to certain & Services Management, P.O. Box 3707, FAA–2009–1066; Directorate Identifier Boeing Model 747 series airplanes. The MC 2H–65, Seattle, Washington 98124– 2009–NM–028–AD’’ at the beginning of existing AD currently requires repetitive 2207; telephone 206–544–5000, your comments. We specifically invite inspections to detect cracking in certain extension 1, fax 206–766–5680; e-mail comments on the overall regulatory, fuselage skin lap joints, and repair if [email protected]; Internet economic, environmental, and energy necessary. This proposed AD would https://www.myboeingfleet.com. You aspects of this proposed AD. We will expand the inspection area in the may review copies of the referenced consider all comments received by the existing AD, add a modification of service information at the FAA, closing date and may amend this certain lap joints, and add certain post- Transport Airplane Directorate, 1601 proposed AD because of those repair inspections of the lap joints. Lind Avenue, SW., Renton, Washington. comments. Accomplishing the modification would For information on the availability of We will post all comments we end the repetitive inspections required this material at the FAA, call 425–227– receive, without change, to http:// by the existing AD for the length of lap 1221 or 425–227–1152. www.regulations.gov, including any
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personal information you provide. We for Groups 1, 2, 4, 5, and 7 through 10 instructions are included for Groups 3 will also post a report summarizing each airplanes. For airplanes on which any and 6 airplanes and recommends substantive verbal contact we receive crack is found during the external contacting Boeing for modification about this proposed AD. surface high frequency eddy current instructions. (HFEC) inspection, the related Discussion investigative action is doing an open- FAA’s Determination and Requirements On May 31, 1994, we issued AD 94– hole HFEC inspection before further of the Proposed AD 12–04, Amendment 39–8932 (59 FR flight for further cracking; and for We have evaluated all pertinent 30277, June 13, 1994), for certain Boeing airplanes on which any crack is found, Model 747 series airplanes. That AD during that inspection, the corrective information and identified an unsafe requires repetitive inspections to detect action is repairing the crack before condition that is likely to develop on cracking in certain fuselage skin lap further flight. other airplanes of the same type design. joints, and repair, if necessary. That AD The compliance time for For this reason, we are proposing this was prompted by the results of accomplishing the new Area 2 AD, which would supersede AD 94–12– extensive pressure fatigue tests inspections is before the accumulation 04 and would retain the requirements of conducted by the manufacturer. We of 22,000 total flight cycles, or within the existing AD. This proposed AD issued that AD to detect and repair 3,000 flight cycles after the last HFEC would also require accomplishing the fatigue cracking in certain lap joints, inspection of the area (as specified in actions specified in the service which will ensure safe operation of the Boeing Model 747 Supplemental information described previously, airplanes that have exceeded their Structural Inspection Document), or except as discussed under ‘‘Differences economic design goal. within 1,000 flight cycles from the date Between the Proposed AD and Service Actions Since Existing AD Was Issued on Revision 2 of the service bulletin, Information.’’ whichever occurs latest. Since we issued AD 94–12–04, the The compliance time for Differences Between the Proposed AD manufacturer has conducted a structural accomplishing the inspections in and Service Information review of affected skin lap joints for Section 41 at stringer 6 for Groups 2, 4, widespread fatigue damage, and has 8, and 9 airplanes not affected by Boeing Revision 3 of the service bulletin identified additional inspection and Service Bulletin 747–53–2253 is within specifies to contact the manufacturer for modification requirements. It was 10,000 flight cycles after doublers are instructions on how to repair or modify determined that it is necessary to installed per Boeing Service Bulletin certain conditions, but this proposed inspect lap joints with an upper skin 747–53–2272. These requirements are AD would require those conditions be thickness of 0.09 inch in addition to the specified in AD 2008–10–15, done in one of the following ways: areas inspected in accordance with the Amendment 39–15522 (73 FR 29042, • Using a method that we approve; or existing AD. For Model 747SP airplanes, May 20, 2008). • the skin lap joints in Section 44 are also For areas on which a lap joint repair Using data that meet the included in those inspections. It was was installed and the repair doubler is certification basis of the airplane, and determined that lap joints in Sections 41 greater than or equal to 40 inches long, that have been approved by an and 42 with an upper skin thickness of Revision 3 of the service bulletin Authorized Representative for the 0.071 inch or less should be modified; describes procedures for repetitive Boeing Commercial Airplanes and post-repair inspections are internal surface HFEC inspections for Delegation Option Authorization necessary. cracks. The compliance time for Organization whom we have authorized accomplishing the initial inspection is to make those findings. Revised Service Information within 15,000 flight cycles after the Revision 3 of the service bulletin We have reviewed Boeing Alert repair was installed. recommends that the modification be Service Bulletin 747–53A2367, Revision Revision 3 of the service bulletin done before the accumulation of 30,000 2, dated October 30, 2008 (‘‘Revision 2 specifies repeating the applicable total flight cycles or within 3,000 flight of the service bulletin’’); and Boeing inspection at intervals not to exceed Service Bulletin 747–53A2367, Revision 3,000 flight cycles, or at intervals not to cycles after the release date of Revision 3, dated January 15, 2009 (‘‘Revision 3 exceed 1,500 flight cycles for airplanes 2 of the service bulletin, ‘‘whichever is of the service bulletin’’). We referred to that have accumulated 30,000 total earlier.’’ However, the manufacturer has Boeing Service Bulletin 747–53–2367, flight cycles or more. For Group 7, 8, informed us that an error was made in dated December 18, 1991 (‘‘the original and 9 airplanes, the inspections of the that compliance time and it should issue of the service bulletin’’); and lap joints in Section 46 at stringer 4 left, specify ‘‘whichever occurs later.’’ The Boeing Service Bulletin 747–53–2367, between body stations 1720 and 1740, correct compliance time is specified in Revision 1, dated January 27, 1994 and between body stations 1960 and paragraph (j) of this AD. (‘‘Revision 1 of the service bulletin’’); as 1980, are repeated at intervals not to Changes to Existing AD the appropriate sources of service exceed 1,500 flight cycles. information for accomplishing the For all airplanes, the compliance time This proposed AD would retain all actions required by AD 94–12–04. for accomplishing the lap joint requirements of AD 94–12–04. Since Revisions 2 and 3 of the service modification is before the accumulation that AD was issued, the AD format has bulletin retain the procedures described of 30,000 total flight cycles, or within been revised, and certain paragraphs in the original issue of the service 3,000 flight cycles from the date of have been rearranged. As a result, the bulletin and Revision 1 of the service Revision 2 of the service bulletin, corresponding paragraph identifiers bulletin; however, those revisions add whichever is later. Accomplishing this have changed in this proposed AD, as procedures for a new inspection area modification eliminates the need for the listed in the following table: (Area 2) in Sections 41, 42, 44, and 46. repetitive inspections for the length of Revisions 2 and 3 of the service bulletin lap joint that is modified. also add procedures for a modification Revision 3 of the service bulletin also of the lap joints in Sections 41 and 42 specifies that no lap joint modification
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REVISED PARAGRAPH IDENTIFIERS promoting safe flight of civil aircraft in Affected ADs air commerce by prescribing regulations (b) This AD supersedes AD 94–12–04, Corresponding for practices, methods, and procedures Amendment 39–8932. Requirement in requirement in the Administrator finds necessary for AD 94–12–04 this proposed Applicability AD safety in air commerce. This regulation is within the scope of that authority (c) This AD applies Boeing Model 747–100, 747–100B, 747–100B SUD, 747–200B, 747– Paragraphs (a), (b), and (c) Paragraph (g). because it addresses an unsafe condition 300, 747SR, and 747SP series airplanes, that is likely to exist or develop on certificated in any category, as identified in We have also revised paragraph products identified in this rulemaking Boeing Service Bulletin 747–53A2367, (g)(2)(i) of this AD (paragraph (c)(1) of action. Revision 3, dated January 15, 2009. AD 94–12–04) to remove reference to Subject Chapter 53–30–03 of the Boeing 747 Regulatory Findings Structural Repair Manual (SRM). We have determined that this (d) Air Transport Association (ATA) of Instead, that paragraph instructs proposed AD would not have federalism America Code 53: Fuselage. operators to contact the FAA for repair implications under Executive Order Unsafe Condition instructions. We have also added a new 13132. This proposed AD would not (e) This AD results from a structural review Note 1 to specify that guidance on have a substantial direct effect on the of affected skin lap joints for widespread repairing any subject cracking can be States, on the relationship between the fatigue damage. The Federal Aviation found in Chapter 53–30–03 of the national Government and the States, or Administration is issuing this AD to prevent Boeing 747 SRM. on the distribution of power and fatigue cracking in certain lap joints which responsibilities among the various could result in rapid depressurization of the Costs of Compliance levels of government. airplane. There are about 209 airplanes of the For the reasons discussed above, I Compliance affected design in the worldwide fleet. certify that the proposed regulation: (f) You are responsible for having the This proposed AD would affect about 69 1. Is not a ‘‘significant regulatory actions required by this AD performed within airplanes of U.S. registry. action’’ under Executive Order 12866; the compliance times specified, unless the The actions that are required by AD 2. Is not a ‘‘significant rule’’ under the actions have already been done. 94–12–04 and retained in this proposed DOT Regulatory Policies and Procedures Restatement of Requirements of AD 94–12– AD take about 14 work hours per (44 FR 11034, February 26, 1979); and 04, With Revised Service Information airplane, at an average labor rate of $80 3. Will not have a significant per work hour. Based on these figures, economic impact, positive or negative, Repetitive Inspections the estimated cost of the currently on a substantial number of small entities (g) For airplanes identified in Boeing required actions is $1,120 per airplane, under the criteria of the Regulatory Service Bulletin 747–53–2367, dated per inspection cycle. Flexibility Act. December 18, 1991: Prior to the accumulation The new proposed Area 2 inspections We prepared a regulatory evaluation of 22,000 full pressure flight cycles (or, if the would take about 477 work hours per of the estimated costs to comply with external skin panel of an affected lap joint has been replaced, prior to the accumulation airplane, depending on airplane this proposed AD and placed it in the of 22,000 full pressure flight cycles since skin configuration, at an average labor rate of AD docket. See the ADDRESSES section replacement), or within 1,000 landings after $80 per work hour. Based on these for a location to examine the regulatory July 13, 1994 (the effective date of AD 94– figures, the estimated cost of the new evaluation. 12–04), whichever occurs later, perform an actions specified in this proposed AD external surface high frequency eddy current List of Subjects in 14 CFR Part 39 for U.S. operators is between $38,160 (HFEC) inspection of the skin around the and $2,633,040, or between $2,400 and Air transportation, Aircraft, Aviation upper row of fasteners, in accordance with $3,840 per airplane, per inspection safety, Incorporation by reference, the Accomplishment Instructions of Boeing Safety. Service Bulletin 747–53–2367, dated cycle. December 18, 1991; Revision 1, dated January The new proposed modification The Proposed Amendment 27, 1994; Boeing Alert Service Bulletin 747– would take about 171 work hours per 53A2367, Revision 2, dated October 30, 2008; airplane, at an average labor rate of $80 Accordingly, under the authority or Boeing Service Bulletin 747–53A2367, per work hour. Required parts cost per delegated to me by the Administrator, Revision 3, dated January 15, 2009. As of the airplane would be minimal. Based on the FAA proposes to amend 14 CFR part effective date of this AD, only Revision 3 of these figures, the estimated cost of the 39 as follows: the service bulletin may be used. new actions specified in this proposed (1) If no crack is found, repeat the PART 39—AIRWORTHINESS AD for U.S. operators is $943,920, or inspection thereafter at intervals not to DIRECTIVES exceed 3,000 full pressure flight cycles until $13,680, per airplane. the inspections required by paragraph (h) of Authority for This Rulemaking 1. The authority citation for part 39 this AD are done. continues to read as follows: (2) If any crack is found, accomplish Title 49 of the United States Code Authority: 49 U.S.C. 106(g), 40113, 44701. paragraphs (g)(2)(i) and (g)(2)(ii) of this AD. specifies the FAA’s authority to issue (i) Prior to further flight, perform an open rules on aviation safety. Subtitle I, § 39.13 [Amended] hole HFEC inspection to detect cracking in Section 106, describes the authority of 2. The FAA amends § 39.13 by the upper row fastener holes between the the FAA Administrator. Subtitle VII, removing Amendment 39–8932 (59 FR adjacent frames, in accordance with the Aviation Programs, describes in more Accomplishment Instructions of Boeing 30277, June 13, 1994) and adding the Service Bulletin 747–53–2367, dated detail the scope of the Agency’s following new AD: authority. December 18, 1991; Revision 1, dated January We are issuing this rulemaking under Boeing: Docket No. FAA–2009–1066; 27, 1994; Boeing Alert Service Bulletin 747– Directorate Identifier 2009–NM–028–AD. 53A2367, Revision 2, dated October 30, 2008; the authority described in Subtitle VII, or Boeing Service Bulletin 747–53A2367, Part A, Subpart III, Section 44701, Comments Due Date Revision 3, dated January 15, 2009. Prior to ‘‘General requirements.’’ Under that (a) The FAA must receive comments on further flight, repair any crack found, in section, Congress charges the FAA with this AD action by January 4, 2010. accordance with a method approved by the
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Manager, Seattle Aircraft Certification Office requires compliance within the specified SUMMARY: This action proposes to (ACO), FAA. compliance time after the effective date of establish Class E airspace at Monterey Note 1: Guidance on repairing cracking can this AD. Peninsula Airport, Monterey, CA. be found in Chapter 53–30–03 of the Boeing (l) Where Boeing Service Bulletin 747– Additional controlled airspace is 53A2367, Revision 3, dated January 15, 2009, 747 Structural Repair Manual. necessary to accommodate aircraft using (ii) Repeat the inspection required by specifies to contact Boeing for repair or modification instructions: Before further a new Area Navigation (RNAV) paragraph (g) of this AD thereafter at Required Navigation Performance (RNP) intervals not to exceed 3,000 full pressure flight, repair or modify using a method flight cycles until the inspections required by approved in accordance with the procedures Standard Instrument Approach paragraph (h) of this AD are done. specified in paragraph (m) of this AD. Procedure (SIAP) at Monterey Peninsula Airport. The FAA is proposing this New Requirements of This AD Alternative Methods of Compliance (AMOCs) action to enhance the safety and Repetitive Inspections/Investigative and (m)(1) The Manager, Seattle ACO, has the management of aircraft operations at Corrective Actions authority to approve AMOCs for this AD, if Monterey Peninsula Airport, Monterey, (h) For all airplanes: Do initial and requested using the procedures found in 14 CA. repetitive HFEC inspections for cracks of lap CFR 39.19. Send information to ATTN: Ivan DATES: Comments must be received on joints in Sections 41, 42, 44, and 46, by doing Li, Aerospace Engineer, Airframe Branch, or before January 4, 2010. all the actions, including all applicable ANM–120S, FAA, Seattle ACO, 1601 Lind related investigative and corrective actions, Avenue, SW., Renton, Washington 98057– ADDRESSES: Send comments on this specified in the Accomplishment 3356; telephone (425) 917–6437; fax (425) proposal to the U.S. Department of Instructions of Boeing Service Bulletin 747– 917–6590. Or, e-mail information to 9-ANM- Transportation, Docket Operations, M– 53A2367, Revision 3, dated January 15, 2009, [email protected]. 30, West Building Ground Floor, Room except as provided by paragraph (l) of this (2) To request a different method of W12–140, 1200 New Jersey Avenue, SE., AD. Do the inspections at the applicable compliance or a different compliance time Washington, DC 20590. Telephone (202) times specified in paragraph 1.E. of Boeing for this AD, follow the procedures in 14 CFR Service Bulletin 747–53A2367, Revision 3, 39.19. Before using any approved AMOC on 366–9826. You must identify FAA dated January 15, 2009, except as required by any airplane to which the AMOC applies, Docket No. FAA–2009–1030; Airspace paragraph (k) of this AD. Do all applicable notify your principal maintenance inspector Docket No. 09–AWP–8, at the beginning related investigative and corrective actions (PMI) or principal avionics inspector (PAI), of your comments. You may also submit before further flight. Accomplishing the as appropriate, or lacking a principal comments through the Internet at inspections required by this paragraph ends inspector, your local Flight Standards District http://www.regulations.gov. the repetitive inspections required by Office. The AMOC approval letter must FOR FURTHER INFORMATION CONTACT: paragraph (g) of this AD. Do the actions specifically reference this AD. required by paragraph (h) of this AD until the (3) An AMOC that provides an acceptable Eldon Taylor, Federal Aviation modification required by paragraph (j) of this level of safety may be used for any repair Administration, Operations Support AD is done. required by this AD, if it is approved by an Group, Western Service Center, 1601 (i) For areas on which a lap joint repair was Authorized Representative for the Boeing Lind Avenue, SW., Renton, WA 98057; installed and the repair doubler is greater Commercial Airplanes Delegation Option telephone (425) 203–4537. than or equal to 40 inches long: Do initial Authorization Organization who has been SUPPLEMENTARY INFORMATION: and repetitive internal HFEC inspections for authorized by the Manager, Seattle ACO, to cracks, as required by paragraph (h) of this make those findings. For a repair method to Comments Invited AD, by doing all the applicable actions, be approved, the repair must meet the including applicable corrective actions, certification basis of the airplane, and the Interested parties are invited to specified in the Accomplishment approval must specifically refer to this AD. participate in this proposed rulemaking Instructions of Boeing Service Bulletin 747– (4) AMOCs approved previously in by submitting such written data, views, 53A2367, Revision 3, dated January 15, 2009, accordance with AD 94–12–04 are approved or arguments, as they may desire. except as provided by paragraph (l) of this as alternative methods of compliance with Comments that provide the factual basis AD. Do the inspection and corrective actions the corresponding requirements of this AD. at the times specified in paragraph 1.E. of supporting the views and suggestions Boeing Service Bulletin 747–53A2367, Issued in Renton, Washington, on presented are particularly helpful in Revision 3, dated January 15, 2009, except as November 6, 2009. developing reasoned regulatory required by paragraph (k) of this AD. Ali Bahrami, decisions on the proposal. Comments Terminating Action Manager, Transport Airplane Directorate, are specifically invited on the overall Aircraft Certification Service. regulatory, aeronautical, economic, (j) Before the accumulation of 30,000 total flight cycles or within 3,000 flight cycles [FR Doc. E9–27632 Filed 11–17–09; 8:45 am] environmental, and energy-related after the effective date of this AD, whichever BILLING CODE 4910–13–P aspects of the proposal. occurs later: Modify the applicable lap joints Communications should identify both in Sections 41 and 42 by doing all the actions docket numbers (FAA Docket No. FAA specified in the Accomplishment DEPARTMENT OF TRANSPORTATION 2009–1030 and Airspace Docket No. 09– Instructions of Boeing Service Bulletin 747– AWP–8) and be submitted in triplicate 53A2367, Revision 3, dated January 15, 2009, Federal Aviation Administration to the Docket Management System (see except as required by paragraph (l) of this ADDRESSES section for address and AD. Accomplishing this modification 14 CFR Part 71 terminates the repetitive inspection phone number). You may also submit requirements of this AD for the length of lap [Docket No. FAA–2009–1030; Airspace comments through the Internet at joint that is modified. Docket No. 09–AWP–8] http://www.regulations.gov. Commenters wishing the FAA to Exceptions to Boeing Service Bulletin 747– Proposed Establishment of Class E 53A2367, Revision 3 acknowledge receipt of their comments Airspace; Monterey, CA on this action must submit with those (k) Where Boeing Service Bulletin 747– comments a self-addressed stamped 53A2367, Revision 3, dated January 15, 2009, AGENCY: Federal Aviation specifies compliance times ‘‘from the date on Administration (FAA), DOT. postcard on which the following statement is made: ‘‘Comments to FAA the original issue of this service bulletin [12/ ACTION: Notice of proposed rulemaking Docket No. FAA–2009–1030 and 18/91],’’ and ‘‘from the date on Revision 2 of (NPRM). this service bulletin [10/30/08],’’ this AD Airspace Docket No. 09–AWP–8’’. The
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postcard will be date/time stamped and listed in this document will be Airspace Designations and Reporting returned to the commenter. published subsequently in this Order. Points, signed August 27, 2009, and All communications received on or The FAA has determined that this effective September 15, 2009 is before the specified closing date for proposed regulation only involves an amended as follows: comments will be considered before established body of technical Paragraph 6002 Class E Airspace taking action on the proposed rule. The regulations for which frequent and Designated as Surface Areas proposal contained in this action may routine amendments are necessary to be changed in light of comments keep them operationally current. * * * * * received. All comments submitted will Therefore, this proposed regulation; (1) AWP CA, E2 Monterey, CA [New] be available for examination in the is not a ‘‘significant regulatory action’’ Monterey Peninsula Airport, CA public docket both before and after the under Executive Order 12866; (2) is not (Lat. 36°35′13″ N., long. 121°50′35″ W.) closing date for comments. A report a ‘‘significant rule’’ under DOT ILS Localizer summarizing each substantive public Regulatory Policies and Procedures (44 (Lat. 36°34′58″ N., long. 121°49′55″ W.) contact with FAA personnel concerned FR 11034; February 26, 1979); and (3) Within a 5-mile radius of the Monterey with this rulemaking will be filed in the does not warrant preparation of a Peninsula Airport, and within 3 miles each docket. regulatory evaluation as the anticipated side of the localizer east course extending impact is so minimal. Since this is a from the 5-mile radius of Monterey Peninsula Availability of NPRMs routine matter that will only affect air Airport to 10 miles east of the Runway 28R An electronic copy of this document landing threshold, and within 3 miles each traffic procedures and air navigation, it side of the localizer east course extending may be downloaded through the is certified that this proposed rule, from the 10-mile arc to 15.2 miles east of the Internet at http://www.regulations.gov. when promulgated, would not have a Runway 28R landing threshold. This Class E Recently published rulemaking significant economic impact on a airspace area is effective during the specific documents can also be accessed through substantial number of small entities dates and times established in advance by a the FAA’s Web page at http:// under the criteria of the Regulatory Notice to Airmen. The effective dates and www.faa.gov/airports_airtraffic/ Flexibility Act. times will thereafter be continuously air_traffic/publications/ The FAA’s authority to issue rules published in the Airport/Facility Directory. airspaceamendments/. regarding aviation safety is found in * * * * * You may review the public docket Title 49 of the U.S. Code. Subtitle 1, Issued in Seattle, Washington, on containing the proposal, any comments Section 106, describes the authority for November 5, 2009. received, and any final disposition in the FAA Administrator. Subtitle VII, Robert E. Henry, person in the Dockets Office (see the Aviation Programs, describes in more Acting Manager, Operations Support Group, ADDRESSES section for the address and detail the scope of the agency’s Western Service Center. phone number) between 9 a.m. and 5 authority. This rulemaking is [FR Doc. E9–27661 Filed 11–17–09; 8:45 am] p.m., Monday through Friday, except promulgated under the authority BILLING CODE 4910–13–P Federal holidays. An informal docket described in subtitle VII, part A, subpart may also be examined during normal I, section 40103. Under that section, the business hours at the Northwest FAA is charged with prescribing DEPARTMENT OF TRANSPORTATION Mountain Regional Office of the Federal regulations to assign the use of the Aviation Administration, Air Traffic airspace necessary to ensure the safety Federal Aviation Administration Organization, Western Service Center, of aircraft and the efficient use of Operations Support Group, 1601 Lind airspace. This regulation is within the 14 CFR Part 71 Avenue, SW., Renton, WA 98057. scope of that authority as it would [Docket No. FAA–2009–1011; Airspace Persons interested in being placed on establish additional controlled airspace Docket No. 09–ANM–19] a mailing list for future NPRM’s should at Monterey Peninsula Airport, contact the FAA’s Office of Rulemaking, Monterey, CA. Proposed Establishment of Class E (202) 267–9677, for a copy of Advisory Airspace; Bryce Canyon, UT Circular No. 11–2A, Notice of Proposed List of Subjects in 14 CFR Part 71 Rulemaking Distribution System, which Airspace, Incorporation by reference, AGENCY: Federal Aviation describes the application procedure. Navigation (air). Administration (FAA), DOT. ACTION: Notice of proposed rulemaking The Proposed Amendment The Proposal (NPRM). The FAA is proposing an amendment Accordingly, pursuant to the to Title 14 Code of Federal Regulations authority delegated to me, the Federal SUMMARY: This action proposes to (14 CFR) part 71 by establishing Class E Aviation Administration proposes to establish Class E airspace at Bryce airspace designated as surface areas at amend 14 CFR part 71 as follows: Canyon Airport, Bryce Canyon, UT. Monterey Peninsula Airport, Monterey, Controlled airspace is necessary to CA. Controlled airspace is necessary to PART 71—DESIGNATION OF CLASS A, accommodate aircraft using a new Area accommodate aircraft using the new B, C, D, AND E AIRSPACE AREAS; AIR Navigation (RNAV) Global Positioning RNAV (RNP) SIAP at Monterey TRAFFIC SERVICE ROUTES; AND System (GPS) Standard Instrument Peninsula Airport. This action would REPORTING POINTS Approach Procedure (SIAP) at Bryce Canyon Airport, Bryce Canyon, UT. The enhance the safety and management of 1. The authority citation for 14 CFR FAA is proposing this action to enhance aircraft operations at Monterey part 71 continues to read as follows: Peninsula Airport, Monterey, CA. the safety and management of Class E airspace designations are Authority: 49 U.S.C. 106(g), 40103, 40113, Instrument Flight Rules (IFR) aircraft 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– operations at Bryce Canyon Airport. published in paragraph 6002, of FAA 1963 Comp., p. 389. Order 7400.9T, signed August 27, 2009, DATES: Comments must be received on and effective September 15, 2009, which § 71.1 [Amended] or before January 4, 2010. is incorporated by reference in 14 CFR 2. The incorporation by reference in ADDRESSES: Send comments on this 71.1. The Class E airspace designation 14 CFR 71.1 of the FAA Order 7400.9T, proposal to the U.S. Department of
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Transportation, Docket Operations, M– Internet at http://www.regulations.gov. when promulgated, would not have a 30, West Building Ground Floor, Room Recently published rulemaking significant economic impact on a W12–140, 1200 New Jersey Avenue, SE., documents can also be accessed through substantial number of small entities Washington, DC 20590. Telephone (202) the FAA’s web page at http:// under the criteria of the Regulatory 366–9826. You must identify FAA www.faa.gov/airports_airtraffic/ Flexibility Act. Docket No. FAA–2009–1011; Airspace air_traffic/publications/ _ The FAA’s authority to issue rules Docket No. 09–ANM–19, at the airspace amendments/. regarding aviation safety is found in You may review the public docket beginning of your comments. You may Title 49 of the U.S. Code. Subtitle I, containing the proposal, any comments also submit comments through the Section 106, describes the authority for received, and any final disposition in Internet at http://www.regulations.gov. the FAA Administrator. Subtitle VII, person in the Dockets Office (see the FOR FURTHER INFORMATION CONTACT: Aviation Programs, describes in more ADDRESSES section for the address and Eldon Taylor, Federal Aviation detail the scope of the agency’s phone number) between 9 a.m. and 5 Administration, Operations Support authority. This rulemaking is p.m., Monday through Friday, except Group, Western Service Center, 1601 promulgated under the authority federal holidays. An informal docket Lind Avenue, SW., Renton, WA 98057; described in Subtitle VII, Part A, may also be examined during normal telephone (425) 203–4537. Subpart I, Section 40103. Under that SUPPLEMENTARY INFORMATION: business hours at the Northwest Mountain Regional Office of the Federal section, the FAA is charged with Comments Invited Aviation Administration, Air Traffic prescribing regulations to assign the use of the airspace necessary to ensure the Interested parties are invited to Organization, Western Service Center, Operations Support Group, 1601 Lind safety of aircraft and the efficient use of participate in this proposed rulemaking airspace. This regulation is within the by submitting such written data, views, Avenue, SW., Renton, WA 98057. Persons interested in being placed on scope of that authority as it would or arguments, as they may desire. establish controlled airspace at Bryce Comments that provide the factual basis a mailing list for future NPRM’s should Canyon Airport, Bryce Canyon, UT. supporting the views and suggestions contact the FAA’s Office of Rulemaking, presented are particularly helpful in (202) 267–9677, for a copy of Advisory List of Subjects in 14 CFR Part 71 developing reasoned regulatory Circular No. 11–2A, Notice of Proposed decisions on the proposal. Comments Rulemaking Distribution System, which Airspace, Incorporation by reference, are specifically invited on the overall describes the application procedure. Navigation (air). regulatory, aeronautical, economic, The Proposal The Proposed Amendment environmental, and energy-related aspects of the proposal. The FAA is proposing an amendment Accordingly, pursuant to the Communications should identify both to Title 14 Code of Federal Regulations authority delegated to me, the Federal docket numbers (FAA Docket No. FAA (14 CFR) part 71 by establishing Class E Aviation Administration proposes to 2009–1011 and Airspace Docket No. 09– airspace extending upward from 700 amend 14 CFR part 71 as follows: ANM–19) and be submitted in triplicate feet above the surface at Bryce Canyon to the Docket Management System (see Airport, Bryce Canyon, UT. Controlled PART 71—DESIGNATION OF CLASS A, ADDRESSES section for address and airspace is necessary to accommodate B, C, D, AND E AIRSPACE AREAS; AIR phone number). You may also submit aircraft using the new RNAV (GPS) TRAFFIC SERVICE ROUTES; AND comments through the Internet at SIAP at Bryce Canyon Airport. This REPORTING POINTS http://www.regulations.gov. action would enhance the safety and Commenters wishing the FAA to management of (IFR) operations at Bryce 1. The authority citation for 14 CFR acknowledge receipt of their comments Canyon Airport, Bryce Canyon, UT. part 71 continues to read as follows: on this action must submit with those Class E airspace designations are published in paragraph 6005 of FAA Authority: 49 U.S.C. 106(g), 40103, 40113, comments a self-addressed stamped 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– postcard on which the following Order 7400.9T, signed August 27, 2009, 1963 Comp., p. 389. statement is made: ‘‘Comments to FAA and effective September 15, 2009, which Docket No. FAA–2009–1011 and is incorporated by reference in 14 CFR § 71.1 [Amended] Airspace Docket No. 09–ANM–19’’. The 71.1. The Class E airspace designation listed in this document will be 2. The incorporation by reference in postcard will be date/time stamped and 14 CFR 71.1 of the FAA Order 7400.9T, returned to the commenter. published subsequently in this Order. The FAA has determined that this Airspace Designations and Reporting All communications received on or Points, signed August 27, 2009, and before the specified closing date for proposed regulation only involves an established body of technical effective September 15, 2009 is comments will be considered before amended as follows: taking action on the proposed rule. The regulations for which frequent and routine amendments are necessary to proposal contained in this action may Paragraph 6005 Class E airspace areas be changed in light of comments keep them operationally current. extending upward from 700 feet or more received. All comments submitted will Therefore, this proposed regulation; (1) above the surface of the earth is not a ‘‘significant regulatory action’’ be available for examination in the * * * * * public docket both before and after the under Executive Order 12866; (2) is not closing date for comments. A report a ‘‘significant rule’’ under DOT ANM UT E5 Bryce Canyon, UT [New] summarizing each substantive public Regulatory Policies and Procedures (44 Bryce Canyon Airport, UT contact with FAA personnel concerned FR 11034; February 26, 1979); and (3) (Lat. 37°42′23″ N., long. 112°08′45″ W.) with this rulemaking will be filed in the does not warrant preparation of a That airspace extending upward from 700 docket. regulatory evaluation as the anticipated feet above the surface within 8 miles each impact is so minimal. Since this is a side of the 047° and 227° bearing from the Availability of NPRMs routine matter that will only affect air airport, extending 18 miles northeast and An electronic copy of this document traffic procedures and air navigation, it 15.9 miles southwest of the airport. may be downloaded through the is certified that this proposed rule, * * * * *
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Issued in Seattle, Washington, on postage payment. Mailers print indicia of failure to comply with rules and November 5, 2009. directly on a mailpiece or on a label that regulations contained in the DMM, Robert E. Henry, is affixed to a mailpiece. submission of false or fictitious Acting Manager, Operations Support Group, Postage meters are devices that allow information, and entering a series of Western Service Center. download, storage, and accounting of unpaid or shortpaid mailpieces and/or [FR Doc. E9–27663 Filed 11–17–09; 8:45 am] postage through the device. Meters print packages in the mailstream. BILLING CODE 4910–13–P indicia that may be IBI or non-IBI, to As part of the Postal Service’s ongoing indicate postage payment. IBI are effort to increase effectiveness, enhance digitally generated indicia that include financial control, and reduce costs, an POSTAL SERVICE a two-dimensional barcode. PC Postage automated process will be implemented products are software-based and by using mail processing equipment and 39 CFR Part 111 Internet-based solutions for managing ancillary information systems to detect postage accounts and postage payment. and capture unpaid and shortpaid IBI Unpaid and Shortpaid Information- Mailers purchase postage using a postage on mailpieces, including pieces Based Indicia Postage Meters and PC computer and print indicia using with postage generated from Click-N- Postage Products desktop or label printers. PC Postage Ship service. This automated process products print IBI indicating postage will supplement and enhance our TM AGENCY: Postal Service . payment and may print directly onto current manual process. ACTION: Proposed rule. mailpieces, shipping labels, and USPS- approved customized labels. PC Postage Unpaid IBI Postage SUMMARY: The Postal Service is revising products are offered by USPS and Mailpieces with unpaid IBI postage the Mailing Standards of the United USPS-approved commercial providers. are those for which postage is not paid States Postal Service, Domestic Mail IBI postage meters and PC Postage due to the use of counterfeited, ® Manual (DMM ), to implement revenue products, available from authorized replicated, duplicated, falsified, or assurance procedures for information- providers, allow customers to set up and otherwise modified IBI. based indicia (IBI) postage generated manage postage accounts via a secure Shortpaid IBI Postage from postage evidencing systems. An host site, purchase postage via a credit automated process will be implemented card or automated clearing house (ACH) Mailpieces with shortpaid postage are to detect mailpieces with unpaid or transaction, and print postage on those for which the total of the postage shortpaid IBI postage. This automated envelopes, shipping labels, or affixed to a mailpiece is not equal to or process will supplement and enhance customized labels for all mail classes greater than the amount due for the current procedures. except Periodicals and Bound Printed applicable price category and associated DATES: We must receive your comments Matter. criteria such as weight, shape, and zone. on or before December 18, 2009. The Postal Service will use mail The Postal Service will analyze captured data to verify its validity and ADDRESSES: Mail or deliver written processing equipment and ancillary comments to the Manager, Mailing information systems to detect and use this information to identify cases Standards, U.S. Postal Service, 475 capture data for mailpieces with unpaid where unpaid or shortpaid IBI postage L’Enfant Plaza SW., Room 3436, or shortpaid IBI postage from postage exist. Any mailpiece identified with an Washington DC 20260–3436. You may evidencing systems. The Postal Service unpaid or shortpaid IBI may be subject inspect and photocopy all written will analyze this data to ensure its to the following actions: Collection of comments at USPS Headquarters validity and confirm whether sufficient the unpaid or shortpaid postage, debit Library, 475 L’Enfant Plaza SW., 11th postage was paid. In cases where from the customer’s account, revocation Floor N, Washington DC, between 9 a.m. deficient postage is confirmed, the of the customer’s account privileges, and 4 p.m., Monday through Friday. Postal Service will notify the respective and/or civil and criminal fines and PC Postage or postage meter provider to penalties pursuant to existing federal FOR FURTHER INFORMATION CONTACT: C. take corrective measures to recover the law. Customers will work with their PC Scot Atkins, 703–280–7841 or Carol A. appropriate postage. Postage or postage meter providers to Lunkins, 202–268–7262. IBI printed either on a shipping label address shortpaid and unpaid IBI SUPPLEMENTARY INFORMATION: This or directly on a mailpiece are to be used postage disputes and appeals. The PC proposed rule includes mailing as originally printed and are not to be Postage or postage meter provider will standards for postage printed using IBI counterfeited, replicated, duplicated, work with the Postal Service to resolve ® postage meters and PC Postage falsified, or otherwise modified. In such appeals. products including postage generated addition, the IBI postage affixed to a Although we are exempt from the from Click-N-Ship® service. These mailpiece must be equal to or greater notice and comment requirements of the technologies provide convenience and than the amount due for the applicable Administrative Procedure Act [5 U.S.C ease of use for printing and payment of price category and associated criteria of 553(b), (c)] regarding proposed postage. However, sufficient revenue such as weight, shape, and zone. rulemaking by 39 U.S.C. 410 (a), we assurance procedures and practices Counterfeiting, replicating, duplicating, invite public comments on the must be implemented to ensure all falsifying, or otherwise modifying IBI following proposed revisions to Mailing required postage is paid. and not affixing the applicable amount Standards of the United States Postal Postage meters and PC Postage of postage result in a loss of revenue for Service, Domestic Mail Manual (DMM), products are collectively identified as the Postal Service, because postage is incorporated by reference in the Code of ‘‘postage evidencing systems.’’ A not paid for the pieces mailed. This Federal Regulations. See 39 CFR 111.1. postage evidencing system is a device or deficiency not only affects the Postal List of Subjects in 39 CFR Part 111 system of components a customer uses Service but our customers as well to print evidence that postage required because rising costs may result in price Administrative practice and for a mailing has been paid. Postage adjustments. procedure, Postal Service. evidencing systems print indicia, such USPS® may deny a customer use of a Accordingly, 39 CFR part 111 is as meter imprints or IBI, to indicate postage evidencing system in the event proposed to be amended as follows:
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PART 111—[AMENDED] entering a series of unpaid or shortpaid 8.0 Insufficient or Omitted Postage mailpieces and/or packages in the 8.1 Insufficient Postage 1. The authority citation for 39 CFR mailstream. The customer must make part 111 continues to read as follows: the postage evidencing system and 8.1.1 Definition Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, transaction records available and [Revise the first sentence of 8.1.1 by 401, 403, 404, 414, 416, 3001–3011, 3201– surrender the system to the provider, 3219, 3403–3406, 3621, 3622, 3626, 3632, adding a reference to information-based 3633, and 5001. the USPS, or the USPS agent when indicia as follows:] notified to do so. 2. Revise the following sections of Except Express Mail, Registered Mail, * * * * * Mailing Standards of the United States nonmachinable First-Class Mail, and mail paid with information-based Postal Service, Domestic Mail Manual 4.3 Postage Payment (DMM) as follows: indicia (IBI), all other mail that is 4.3.1 Paying for Postage received at either the office of mailing * * * * * or office of address without enough 600 Basic Standards for All Mailing [Revise the first sentence of 4.3.1 as postage is marked to show the total Services follows:] (rounded off) deficiency of postage and fees due.* * * * * * * * The value of the postage indicia on each mailpiece must be equal to or * * * * * 604 Postage Payment Methods greater than the amount due for the [Add new 8.1.8, Information-based * * * * * applicable price category and associated Indicia Mailpieces With Insufficient criteria such as weight, shape, and zone Postage as follows:] 4.0 Postage Meters and PC Postage or another amount permitted by mailing Products (‘‘Postage Evidencing standards to qualify for existing prices. 8.1.8 Information-Based Indicia Systems’’) Mailpieces With Insufficient Postage *** 4.1 Basic Information * * * * * The total of the postage affixed to a mailpiece must be equal to or greater * * * * * [Add new 4.3.6, Shortpaid than the amount due for the applicable Information-based Indicia as follows:] 4.1.2 Product Categories price category and associated criteria * * * The primary characteristics of 4.3.6 Shortpaid Information-Based such as weight, shape, and zone. When postage meters and PC Postage products Indicia USPS determines during any phase of are described below. processing that mailpieces bearing an * * * * * Mailpieces bearing shortpaid information-based indicia (IBI) are [Revise item ‘‘b’’ of 4.1.2 as follows:] information-based indicia (IBI) postage shortpaid mailpieces, the Postal Service b. PC Postage products are software- are those for which the postage will notify the respective PC Postage or based and Internet-based solutions for indicated in the IBI is not equal to or postage meter provider to take necessary managing postage accounts and postage greater than the postage for the actions to recover revenue loss for the payment. Mailers purchase postage applicable price category and associated total amount of postage due from the using a computer and print indicia criteria such as weight, shape, and zone. customer’s PC Postage or postage meter using desktop or label printers. PC Mailpieces bearing shortpaid IBI postage account. The customer may appeal the Postage products print information- are treated as having insufficient decision through the PC Postage or based indicia (IBI) indicating postage postage (see 8.1.8). Customers who postage meter provider. If the customer payment and may print directly onto repeatedly deposit mail with shortpaid repeatedly deposits mailings with mailpieces, shipping labels, and USPS- postage will be subject to revocation of shortpaid postage, the PC Postage or approved customized labels. PC Postage the privilege to use a postage evidencing postage meter account privileges may be products are offered by the USPS and system. revoked and/or the customer may be USPS-approved commercial providers. subject to the applicable civil and [Add new 4.3.7, Unpaid Information- PC Postage products are typically criminal fines and penalties pursuant to based Indicia as follows:] offered by providers through existing Federal law. subscription service agreements. Some 4.3.7 Unpaid Information-Based 8.2 Omitted Postage components of PC Postage systems may Indicia be purchased as authorized by the 8.2.1 Handling Mail With Omitted USPS. Mailpieces bearing unpaid Postage [Delete item ‘‘c’’ of 4.1.2 in its information-based indicia (IBI) are those [Revise the first sentence of 8.2.1 by entirety.] for which postage is not paid due to the adding a reference to information-based * * * * * use of counterfeited, replicated, indicia as follows:] duplicated, falsified, or otherwise Except mail paid with information- 4.2 Authorization To Use Postage modified IBI. Counterfeited, replicated, Evidencing Systems based indicia, mail of any class and/or duplicated, falsified, or otherwise indicating extra services that is received * * * * * modified IBI are not acceptable as at either the office of mailing or office [Revise title and text of 4.2.4 as payment of postage and are treated as of address without postage is endorsed follows:] omitted postage (see 8.2.3). Customers ‘‘Returned for Postage’’ and is returned 4.2.4 Denial of Authorization To Use who repeatedly deposit mail with forms to the sender without an attempt at of nonpayment will be subject to USPS may deny use of a postage delivery. * * * revocation of the privilege to use a evidencing system in the event of failure * * * * * postage evidencing system. to comply with rules and regulations [Add new 8.2.3, Handling Mail With contained in the DMM, submission of * * * * * Unpaid Information-based Indicia as false or fictitious information, and for follows:]
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8.2.3 Handling Mail With Unpaid December 2, 2009. The purpose of this encryption, and be free of any defects or Information-Based Indicia notice is to provide the public an viruses. The total of the postage affixed to a opportunity to review and comment on Docket: All documents in the mailpiece must be equal to or greater the additional modeling data, which electronic docket are listed in the than the amount due for the applicable were described in the proposed http://www.regulations.gov index. price category and associated criteria rulemaking notice and are further Although listed in the index, some such as weight, shape, and zone. When described below. information is not publicly available, Readers should note that only the USPS determines during any phase i.e., CBI or other information whose comments about the new modeling data of processing that mailpieces bearing an disclosure is restricted by statute. discussed in this document and related information-based indicia (IBI) are Certain other material, such as issues will be considered during the unpaid due to the use of counterfeited, copyrighted material, is not placed on comment period. Issues related to the replicated, duplicated, falsified, or the Internet and will be publicly August 19, 2009 proposed rule that are otherwise modified IBI, the USPS will available only in hard copy form. not directly affected by the data notify the PC Postage or postage meter Publicly available docket materials are referenced in this Notice of Data provider to take necessary actions to available either electronically in http:// Availability are not open for further reclaim revenue loss for the total www.regulations.gov or in hard copy at comment. amount of omitted postage. The EPA Region IX, 75 Hawthorne Street, customer may appeal the decision DATES: EPA will accept comments on San Francisco, California. To inspect the through their PC Postage or postage the modeling data and related issues hard copy materials, please schedule an meter provider. The PC Postage or until December 2, 2009. appointment during normal business postage meter account may be revoked ADDRESSES: Submit your comments, hours with the contact listed in the FOR and/or the customer may be subject to identified by Docket ID No. EPA–R09– FURTHER INFORMATION CONTACT section. applicable civil and criminal fines and OAR–2009–0470, by one of the FOR FURTHER INFORMATION CONTACT: penalties pursuant to existing Federal following methods: Jeffrey Buss, EPA Region IX, (415) 947– law. 1. Federal eRulemaking Portal: 4152, [email protected]. http://www.regulations.gov. Follow the * * * * * SUPPLEMENTARY INFORMATION: on-line instructions. We will publish an appropriate Throughout this document, the terms amendment to 39 CFR part 111 to reflect 2. E-mail: [email protected]. 3. Mail or deliver: Jeffrey Buss (Air-2), ‘‘we’’, ‘‘us’’, and ‘‘our’’ refer to EPA. these changes if our proposal is On August 19, 2009 (74 FR 41818), adopted. U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San EPA proposed to approve state Stanley F. Mires, Francisco, CA 94105–3901. implementation plan (SIP) revisions Chief Counsel, Legislative. Instructions: All comments will be submitted by the California Air [FR Doc. E9–27628 Filed 11–17–09; 8:45 am] included in the public docket without Resources Board (CARB) on June 5, 2009 relating to the State’s basic and BILLING CODE 7710–12–P change and may be made available online at http://www.regulations.gov, enhanced vehicle I/M program (‘‘2009 including any personal information I/M Revision’’) contingent upon provided, unless the comment includes California’s submittal of revisions to the ENVIRONMENTAL PROTECTION enhanced program performance AGENCY Confidential Business Information (CBI) or other information whose disclosure is standard evaluations to address a 40 CFR Part 52 restricted by statute. Information that different attainment year for the you consider CBI or otherwise protected Western Mojave Desert 8-hour ozone [EPA–R09–OAR–2009–0470; FRL–8978–2] should be clearly identified as such and nonattainment area and to address should not be submitted through California’s base-year program Approval and Promulgation of Air performance. Quality Implementation Plans; http://www.regulations.gov or e-mail. As explained in the August 19, 2009 California; Motor Vehicle Inspection The http://www.regulations.gov portal is proposal, these revisions to California’s and Maintenance Program; Proposed an ‘‘anonymous access’’ system, which enhanced program performance Rule—Notice of Data Availability and means EPA will not know your identity standard evaluation were necessary for Request for Comment or contact information unless you provide it in the body of your comment. two reasons. First, the submitted AGENCY: Environmental Protection If you send e-mail directly to EPA performance modeling evaluation for Agency (EPA). without going through http:// the Western Mojave Desert 8-hour ozone ACTION: Notice of data availability www.regulations.gov, your e-mail nonattainment area was based on the (NODA) and request for comment. address will be automatically captured State’s choice of 2020 as the horizon and included as part of the comment year, based on the attainment deadline SUMMARY: The EPA is providing notice that is placed in the public docket and for 8-hour ozone nonattainment areas that it has placed in the docket for the made available on the Internet. If you classified as ‘‘severe-17.’’ 1 Because EPA proposed rulemaking concerning submit an electronic comment, EPA interprets CAA section 181(b)(3) as California’s June 5, 2009 Motor Vehicle recommends that you include your disallowing state requests to reclassify Inspection and Maintenance (I/M) name and other contact information in ozone nonattainment areas to ‘‘severe- program submittal additional modeling the body of your comment and with any 17,’’ we noted that the State must data relevant to the proposed disc or CD–ROM you submit. If EPA submit a revised modeling evaluation rulemaking, published on August 19, cannot read your comment due to 2009. The August 19, 2009 notice technical difficulties and cannot contact 1 By letter dated February 14, 2008, CARB established a 30-day comment period on you for clarification, EPA may not be requested reclassification of the Western Mojave Desert 8-hour ozone nonattainment area to ‘‘severe- EPA’s proposal, which ended on able to consider your comment. 17.’’ Western Mojave Desert is currently classified September 18, 2009. EPA is reopening Electronic files should avoid the use of as a ‘‘moderate’’ nonattainment area for the 8-hour the comment period to end on special characters, any form of ozone standard. 40 CFR 81.305.
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based on a more appropriate horizon contained in the 2009 I/M Revision, we DATES: Comments on this proposed rule year for this area. 74 FR 41818–41823. believe that California has now must be received by December 18, 2009. Second, CARB did not provide base demonstrated that the California I/M ADDRESSES: Submit your comments, year modeling evaluations for the six program would achieve greater percent identified by Docket ID No. EPA–R10– areas in the State that are subject to the emissions reductions (relative to the no RCRA–2009–0766, by one of the enhanced I/M requirements in 40 CFR I/M scenario) for VOC and NOX in each following methods: part 51, subpart S. The six areas are the of the six areas in the year before the • http://www.regulations.gov: Follow South Coast Air Basin, San Joaquin attainment year than would the EPA the on-line instructions for submitting Valley, Western Mojave Desert, model enhanced I/M program in 2002. comments. Sacramento Metro, Coachella Valley, Moreover, the modeling results for the • E-mail: [email protected]. and Ventura County. We noted that a California I/M program in 2002 show • Mail: Nina Kocourek, U.S. base year modeling run is required to that the California program achieved Environmental Protection Agency, allow for a more definitive conclusion greater percent emissions reductions Region 10, Office of Air, Waste & Toxics that the California enhanced I/M (relative to the no I/M scenario) for VOC (AWT–122), 1200 Sixth Avenue, Suite program obtained the same or lower and NOX in each of the six areas than 900, Seattle, Washington 98101. emission levels as the EPA model the EPA model enhanced I/M program Instructions: Direct your comments to program by January 1, 2002, and that the in 2002. Thus, in view of the results of Docket ID No. EPA–R10–RCRA–2009– program will maintain this level of both the base year and horizon year 0766. EPA’s policy is that all comments emission reduction (or better) through modeling results, we believe that the received will be included in the public the applicable 8-hour ozone attainment analyses submitted by CARB on October docket without change and may be deadlines, as required by 40 CFR 28, 2009 support the conclusion that the made available online at http:// 51.351(f). Based on our preliminary California I/M program will maintain a www.regulations.gov, including any modeling analyses and evaluation of the greater percent emissions reduction in personal information provided, unless data provided in CARB’s submittal, all six subject areas (relative to the no the comment includes information however, we noted that we expect these I/M scenario) than would the Federal claimed to be Confidential Business revised modeling evaluations will I/M program in the base year, thereby Information (CBI) or other information satisfy the regulatory requirements. 74 meeting the enhanced I/M performance whose disclosure is restricted by statute. FR 41818–41823. In our proposed rule, standard in 40 CFR 51.351(f) and Do not submit information that you we indicated that we would notify the supporting full approval of the 2009 public of any additional information consider to be CBI or otherwise I/M Revision. EPA is today providing that is provided to address these issues. protected through http:// notice and opportunity to comment on Publication of this NODA is intended to www.regulations.gov, or e-mail. The these revised modeling evaluations, serve this purpose. http://www.regulations.gov website is On October 28, 2009, CARB submitted which are available in the docket for the an ‘‘anonymous access’’ system, which the revised enhanced I/M performance proposed action. means EPA will not know your identity modeling analyses described above. We Dated: October 30, 2009. or contact information unless you placed the analyses in the docket on Enrique Manzanilla, provide it in the body of your comment. October 29, 2009. Specifically, CARB Acting Regional Administrator, Region IX. If you send an e-mail comment directly to EPA without going through http:// submitted (1) revised enhanced program [FR Doc. E9–27669 Filed 11–17–09; 8:45 am] www.regulations.gov, your e-mail performance standard evaluations for BILLING CODE 6560–50–P the Western Mojave Desert area based address will be automatically captured on a horizon year of 2018, and (2) 2002 and included as part of the comment base year performance modeling ENVIRONMENTAL PROTECTION that is placed in the public docket and evaluations for the six areas in the State AGENCY made available on the Internet. If you that are subject to the enhanced I/M submit an electronic comment, EPA requirements in 40 CFR part 51, subpart 40 CFR Part 271 recommends that you include your S (the South Coast Air Basin, San name and other contact information in the body of your comment and with any Joaquin Valley, Western Mojave Desert, [EPA–R–10–RCRA–2009–0766; FRL–8977– Sacramento Metro, Coachella Valley, 2] disk or CD–ROM you submit. If EPA and Ventura County). We find that cannot read your comment due to selection of year 2018 by California as Oregon: Proposed Authorization of technical difficulties and cannot contact the ‘‘year before the attainment year’’ for State Hazardous Waste Management you for clarification, EPA may not be Western Mojave Desert for enhanced Program Revision able to consider your comment. performance modeling purposes is Electronic files should avoid the use of acceptable on the presumption that AGENCY: Environmental Protection special characters or any form of CARB will amend its voluntary Agency (EPA). encryption, and be free of any defects or reclassification request from ‘‘severe- ACTION: Proposed rule. viruses. For additional information 17’’ to ‘‘severe-15.’’ We interpret section about EPA’s public docket, visit the EPA 181(b)(3) to allow for voluntary SUMMARY: Oregon has applied to EPA for Docket Center homepage at http:// reclassification by a state to the latter, final authorization of certain changes to www.epa.gov/epahome/dockets.htm. but not the former. its hazardous waste program under the Docket: All documents in the docket We have also reviewed the submitted Resource Conservation and Recovery are listed in the http:// modeling data and find that the inputs Act, as amended (RCRA). EPA has www.regulations.gov index. Although to the MOBILE6.2 model accurately reviewed Oregon’s application and has listed in the index, some information is reflect the California I/M program. preliminarily determined that these not publicly available, e.g., CBI or other Based on the modeling results for changes satisfy all requirements needed information whose disclosure is Western Mojave Desert submitted on to qualify for final authorization, and is restricted by statute. Certain other October 28, 2009, together with the proposing to authorize the State’s material, such as copyrighted material, performance standard modeling results changes. will be publicly available only in hard
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copy. Publicly available docket described in the authorization requirements on the regulated materials are available either application. Oregon will have community because the regulations for electronically in http:// responsibility for permitting Treatment, which Oregon will be authorized are www.regulations.gov or in hard copy Storage, and Disposal Facilities (TSDFs) already effective under State law and during normal business hours at the within its borders, except in Indian are not changed by the act of U.S. Environmental Protection Agency, country (18 U.S.C. 1151), and for authorization. Region 10, Office of Air, Waste & carrying out the aspects of the RCRA Toxics, Mailstop AWT–122, 1200 Sixth program described in its revised D. What Happens if EPA Receives Avenue, Suite 900, Seattle, Washington program application, subject to the Comments on This Action? 98101, contact: Nina Kocourek, phone limitations of the Hazardous and Solid If EPA receives comments on this Waste Amendments of 1984 (HSWA). number: (206) 553–6502; or the Oregon action, we will address those comments New Federal requirements and Department of Environmental Quality, in a later final rule. You may not have prohibitions imposed by Federal 811 SW Sixth Avenue, Portland, another opportunity to comment. If you regulations that EPA promulgates under Oregon, 97204, contact: Scott Latham, want to comment on this authorization, the authority of HSWA, and which are phone number: (503) 229–5953. you must do so at this time. FOR FURTHER INFORMATION CONTACT: not less stringent than existing Nina Kocourek, U.S. Environmental requirements, take effect in authorized E. What Has Oregon Previously Been Protection Agency, Region 10, Office of States before the States are authorized Authorized for? Air, Waste & Toxics (AWT–122), 1200 for the requirements. Thus, EPA will Sixth Avenue, Suite 900, Seattle, implement those requirements and Oregon initially received final Washington 98101, phone number: prohibitions in Oregon, including authorization on January 30, 1986, (206) 553–6502, e-mail: issuing permits, until the State is effective January 31, 1986 (51 FR 3779), [email protected]. granted authorization to do so. to implement the RCRA hazardous waste management program. EPA SUPPLEMENTARY INFORMATION: C. What Will Be the Effect if Oregon Is granted authorization for changes to Authorized for These Changes? A. Why Are Revisions to State Oregon’s program on March 30, 1990, Programs Necessary? If Oregon is authorized for these effective on May 29, 1990 (55 FR changes, a facility in Oregon subject to 11909); August 5, 1994, effective States which have received final RCRA will have to comply with the October 4, 1994 (59 FR 39967); June 16, authorization from EPA under RCRA authorized State requirements in lieu of 1995, effective August 15, 1995 (60 FR section 3006(b), 42 U.S.C. 6926(b), must the corresponding Federal requirements 31642); October 10, 1995, effective maintain a hazardous waste program in order to comply with RCRA. December 7, 1995 (60 FR 52629); that is equivalent to, consistent with, Additionally, such persons will have to September 10, 2002, effective September and no less stringent than the Federal comply with any applicable Federal 10, 2002 (67 FR 57337); and June 26, program. As the Federal program requirements, such as, for example, 2006 effective June 26, 2006 (71 FR changes, States must change their HSWA regulations issued by EPA for 36216) . programs and ask EPA to authorize the which the State has not received changes. Changes to State programs may authorization, and RCRA requirements F. What Changes Are We Proposing? be necessary when Federal or State that are not supplanted by authorized statutory or regulatory authority is State-issued requirements. Oregon EPA is proposing to authorize modified or when certain other changes continues to have enforcement revisions to Oregon’s authorized occur. Most commonly, States must responsibilities under its State program described in Oregon’s official change their programs because of hazardous waste management program program revision application, submitted changes to EPA’s regulations codified in for violations of this program, but EPA to EPA on October 21, 2009 and deemed Title 40 of the Code of Federal retains its authority under RCRA complete by EPA on October 26, 2009. Regulations (CFR) parts 124, 260 sections 3007, 3008, 3013, and 7003, EPA has made a preliminary through 268, 270, 273, and 279. which includes, among others, the determination that Oregon’s hazardous authority to: waste program revisions, as described in B. What Decisions Have We Made in • this proposed rule, satisfy the This Proposed Rule? Conduct inspections; require monitoring, tests, analyses, or reports; requirements necessary to qualify for EPA has preliminarily determined • Enforce RCRA requirements; final authorization. The following table that Oregon’s application to revise its suspend, terminate, modify or revoke identifies equivalent and more stringent authorized program meets all of the permits; and State regulatory analogues to the Federal statutory and regulatory requirements • Take enforcement actions regardless regulations for those regulatory established by RCRA. Therefore, we are of whether the State has taken its own revisions for which Oregon is seeking proposing to grant Oregon final actions. authorization. The referenced analogous authorization to operate its hazardous The action to approve these revisions State authorities were legally adopted waste program with the changes would not impose additional and effective as of June 25, 2009.
Federal Register Analogous state authority Description of Federal requirements CL 1 (Oregon Administrative reference Rules (OAR 340–* * * )
Land Disposal Restrictions: Treatment Variance for Radioactively Contaminated Bat- 67 FR 62618, 11/21/2002 .. –100–0002. teries, CL 201. NESHAP: Standards for Hazardous Air Pollutants for Hazardous Waste Combus- 67 FR 77687, 12/19/2002 .. –100–0002. tors—Corrections, CL 202. Hazardous Waste Management System; Identification and Listing of Hazardous 68 FR 44659, 7/30/2003 .... –100–0002. Waste; Used Oil Management Standards, CL 203. NESHAP: Surface Coating of Automobiles and Light-Duty Trucks, CL 205 ...... 69 FR 22601, 4/26/2004 .... –100–0002.
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Federal Register Analogous state authority Description of federal requirements CL 1 (Oregon Administrative reference Rules (OAR 340–* * * )
Non-wastewaters from Dyes and Pigments, CL 206 ...... 70 FR 9138, 2/24/2005 ...... –100–0002. Non-wastewaters from Dyes and Pigments Correction, CL 206.1 ...... 70 FR 35032, 6/13/2005 .... –100–0002. Uniform Hazardous Waste Manifest, CL 207 2 ...... 70 FR 10776, 3/4/2005 ...... –100–0002. Uniform Hazardous Waste Manifest Correction, CL 207.1 3 ...... 70 FR 35034, 6/16/2005 .... –100–0002. Methods Innovation; SW–846, CL 208 ...... 70 FR 34538, 6/14/2005 .... –100–0002. Methods Innovation; SW–846 Correction, CL 208.1 ...... 70 FR 44150, 8/1/2005 ...... –100–0002. Mercury Containing Equipment, CL 209 ...... 70 FR 45508, 8/5/2005 ...... –100–0002. Headworks Exemption, CL 211 ...... 70 FR 57769, 10/4/2005 .... –100–0002. NESHAP: Phase I Final Replacement Standards, CL 212 ...... 70 FR 59402, 10/12/2005 .. –100–0002. Burden Reduction Rule, CL 213 3 ...... 71 FR 16862, 4/4/2006 ...... –100–0002; –104–0021(1), (2) and (3); –105– 0140(1), (2), (3), (4) and (5). CFR Corrections Rule 1, CL 214 ...... 71 FR 40254, 7/14/2006 .... –100–0002. CRT Exclusion, CL 215 ...... 71 FR 42928, 7/28/2006 .... –100–0002. 1 CL (Checklist) is a document that addresses the specific changes made to the Federal regulations by one or more related final rules pub- lished in the Federal Register. EPA develops these checklists as tools to assist States in developing their authorization application and in docu- menting specific State regulations analogous to the Federal regulations. For more information see EPA’s RCRA State Authorization Web page at http://www.epa.gov/epawaste/osw/laws-regs/state/index.htm. 2 Concurrent with the incorporation by reference of this rule package on June 18, 2009, the Environmental Quality Commission repealed a State-only hazardous waste manifest rule (OAR 340–102–0060) that had previously been authorized by EPA. The State took this action to avoid any potential conflict with the Federal Uniform Hazardous Waste Manifest Rules (CL 207 and 207.1) which are incorporated by reference into Or- egon’s hazardous waste rules and effective State law as of June 25, 2009. 3 State rule contains some more stringent provisions. For identification of the more stringent State provisions refer to the authorization revision application and the Attorney General’s statement for this proposed rule, as well as see discussion below in Section G of this rule.
G. Where Are the Revised State Rules priorities on routine inspections for will continue to implement and issue Different From the Federal Rules? Performance Track member facilities. permits for HSWA requirements for The State also adopted rules which which Oregon is not yet authorized. This section discusses differences deleted those portions of the rule that between the revisions Oregon proposed I. What Is Codification and Is EPA referenced Federal Performance Track to its authorized program and the Codifying Oregon’s Hazardous Waste member facilities. The effect of deleting Federal regulations. EPA’s preliminary those references is that the State’s rules Program as Authorized in This determination is that the State does do not allow any special or Proposed Rule? have more stringent requirements administrative benefits for Performance Codification is the process of placing related to the Federal Burden Reduction Track member facilities. Therefore, the the State’s statutes and regulations that Rule (70 FR 16862, April 4, 2006). State’s rules found at OAR 340–104– comprise the State’s authorized In 1999, EPA initiated a new Federal 0021(1), (2) and (3); OAR 340–105– hazardous waste program into the Code program, National Environmental 0140(1), (2), (3), (4) and (5) are more of Federal Regulations. This is done by Performance Track. This was a stringent than those corresponding referencing the authorized State rules in voluntary program designed to Federal counterparts found at 40 CFR 40 CFR part 272. EPA is reserving the recognize facilities that had a sustained 264.15(b)(4) and (5); 40 CFR 264.174; 40 amendment of 40 CFR part 272, Subpart record of compliance and implemented CFR 264.195(e)(1); 40 CFR 265.15(b)(4) MM for codification to a later date. high quality environmental management and (5); 40 CFR 265.174; 40 CFR J. How Would Authorizing Oregon for systems. EPA provided exclusive 265.195(d); and 40 CFR 265.201(e). regulatory and administrative benefits to These Revisions Affect Indian Country the Performance Track member H. Who Handles Permits After the (18 U.S.C. 1151) in Oregon? facilities. The State of Oregon did not Authorization Takes Effect? Oregon is not authorized to carry out participate in the Federal National Oregon will continue to issue permits its hazardous waste program in Indian Environmental Performance Track for all the provisions for which it is country, as defined in 18 U.S.C. 1151. Program. In May 2009, EPA terminated authorized and administer the permits it Indian country includes: (1) All lands the Federal National Performance Track issues. If EPA issued permits prior to within the exterior boundaries of Indian Program (74 FR 22742, May 14, 2009); authorizing Oregon for these revisions, reservations within or abutting the State therefore there are no current Federal these permits would continue in force of Oregon; (2) Any land held in trust by Performance Track member facilities. until the effective date of the State’s the U.S. for an Indian tribe; and (3) Any However, EPA did not remove the issuance or denial of a State hazardous other land, whether on or off an Indian Federal rules applicable to the waste permit, at which time EPA would reservation, that qualifies as Indian Performance Track member facilities modify the existing EPA permit to country. Therefore, this action has no from its regulations, and if EPA’s expire at an earlier date, terminate the effect on Indian country. EPA will Performance Track Program were existing EPA permit for cause, or allow continue to implement and administer reinstated these Federal rules would the existing EPA permit to otherwise the RCRA program on these lands. continue to be applicable to future expire by its terms, except for those member facilities. facilities located in Indian Country. EPA K. Statutory and Executive Order The State incorporated by reference will not issue new permits or new Reviews the Federal Burden Reduction Rule (70 portions of permits for provisions for This proposed rule seeks to revise the FR 16862, April 4, 2006), which which Oregon is authorized after the State of Oregon’s authorized hazardous included special allowances to lower effective date of this authorization. EPA waste program pursuant to section 3006
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of RCRA and imposes no requirements information; search data sources; on small entities and welcomes other than those currently imposed by complete and review the collection of comments on issues related to such State law. This proposed rule complies information; and transmit or otherwise impacts. with applicable executive orders and disclose the information. 4. Unfunded Mandates Reform Act statutory provisions as follows: An Agency may not conduct or sponsor, and a person is not required to 1. Executive Order 12866 Title II of the Unfunded Mandates respond to, a collection of information Reform Act (UMRA) of 1995 (Pub. L. Under Executive Order 12866 (58 FR unless it displays a currently valid OMB 104–4) establishes requirements for 51735, October 4, 1993), the Agency control number. The OMB control Federal agencies to assess the effects of must determine whether the regulatory numbers for EPA’s regulations in Title their regulatory actions on State, local, action is ‘‘significant’’, and therefore 40 of the CFR are listed in 40 CFR part and tribal governments and the private subject to OMB review and the 9. sector. Under section 202 of the UMRA, requirements of the Executive Order. EPA generally must prepare a written The Executive Order defines 3. Regulatory Flexibility Act statement, including a cost-benefit ‘‘significant regulatory action’’ as one The Regulatory Flexibility Act (RFA) analysis, for proposed and final rules that is likely to result in a rule that may: generally requires Federal agencies to with ‘‘Federal mandates’’ that may (1) Have an annual effect on the prepare a regulatory flexibility analysis result in expenditures and final rules economy of $100 million or more, or of any rule subject to notice and with ‘‘Federal mandates’’ that may adversely affect in a material way, the comment rulemaking requirements economy, a sector of the economy, under the Administrative Procedure Act result in expenditures to State, local, productivity, competition, jobs, the or any other statute unless the agency and tribal governments, in the aggregate, environment, public health or safety, or certifies that the rule will not have a or to the private sector, of $100 million State, local, or tribal governments or significant economic impact on a or more in any one year. Before communities; (2) create a serious substantial number of small entities. promulgating an EPA rule for which a inconsistency or otherwise interfere Small entities include small businesses, written statement is needed section 205 with an action taken or planned by small organizations, and small of the UMRA generally requires EPA to another agency; (3) materially alter the governmental jurisdictions. For identify and consider a reasonable budgetary impact of entitlements, purposes of assessing the impacts of number of regulatory alternatives and grants, user fees, or loan programs, or today’s proposed rule on small entities, adopt the least costly, most cost- the rights and obligations of recipients small entity is defined as: (1) A small effective or least burdensome alternative thereof; or (4) raise novel legal or policy business defined by the Small Business that achieves the objectives of the rule. issues arising out of legal mandates, the Administration’s size regulations at 13 The provisions of section 205 do not President’s priorities, or the principles CFR 121.201; (2) a small governmental apply when they are inconsistent with set forth in the Executive Order. EPA jurisdiction that is a government of a applicable law. Moreover, section 205 has determined that this proposed rule city, county, town, school district, or allows EPA to adopt an alternative other is not a ‘‘significant regulatory action’’ special district with a population of less than the least costly, most cost-effective, under the terms of Executive Order than 50,000; and (3) a small or least burdensome alternative if the 12866 and is therefore not subject to organization that is any not-for-profit Administrator publishes with the rule OMB review. enterprise which is independently an explanation why the alternative was owned and operated and is not not adopted. Before EPA establishes any 2. Paperwork Reduction Act dominant in its field. As part of the regulatory requirements that may This proposed action does not impose State’s rule development process, the significantly or uniquely affect small an information collection burden under State of Oregon prepared a ‘‘Department governments, including tribal the provisions of the Paperwork of Environmental Quality (DEQ) Chapter governments, it must have developed Reduction Act, 44 U.S.C. 3501 et seq., 340, Proposed Rulemaking Statement of under section 203 of the UMRA a small because this proposed rule does not Need and Fiscal and Economic Impact’’ government agency plan. The plan must establish or modify any information or which included an analysis on impacts provide for notifying potentially recordkeeping requirements for the to small businesses. The State affected small governments, enabling regulated community and only seeks to concluded that there are no economic or officials of affected small governments authorize the pre-existing requirements fiscal impacts resulting from DEQ’s to have meaningful and timely input in under State law and imposes no proposed rulemaking. See the Oregon the development of EPA regulatory additional requirements beyond those Environmental Quality Commission proposals with significant Federal imposed by State law. Agenda, dated June 19, 2009, Action intergovernmental mandates, and Burden means the total time, effort, or Item N—Hazardous Waste Omnibus informing, educating, and advising financial resources expended by persons Rulemaking, Attachment E, for the DEQ small governments on compliance with to generate, maintain, retain, or disclose ‘‘Impact to Small Business Analysis’’ the regulatory requirements. Today’s or provide information to or for a http://www.deq.state.or.us/about/eqc/ proposed rule contains no Federal Federal agency. This includes the time agendas/2009/ mandates (under the regulatory needed to review instructions; develop, 2009juneEQCagenda.htm. I certify that provisions of Title II of the UMRA) for acquire, install, and utilize technology this proposed rule will not have a State, local, or tribal governments or the and systems for the purposes of significant economic impact on a private sector. It imposes no new collecting, validating, and verifying substantial number of small entities enforceable duty on any State, local or information, processing, and because the proposed rule will only tribal governments or the private sector. maintaining information, and disclosing have the effect of authorizing pre- Similarly, EPA has also determined that and providing information; adjust the existing requirements under State law this proposed rule contains no existing ways to comply with any and imposes no additional requirements regulatory requirements that might previously applicable instructions and beyond those imposed by State law. significantly or uniquely affect small requirements; train personnel to be able EPA continues to be interested in the government entities. Thus, today’s to respond to a collection of potential impacts of the proposed rule proposed rule is not subject to the
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requirements of sections 202 and 203 of 9. National Technology Transfer and Authority: This proposed action is issued the UMRA. Advancement Act under the authority of sections 2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act, 5. Executive Order 13132: Federalism Section 12(d) of the National as amended, 42 U.S.C. 6912(a), 6926, 6974(b). This proposed rule does not have Technology Transfer and Advancement Dated: October 27, 2009. federalism implications. It will not have Act of 1995 (‘‘NTTAA’’), Public Law Michelle L. Pirzadeh, substantial direct effects on the States, 104–113, 12(d) (15 U.S.C. 272), directs Acting Regional Administrator, Region 10. on the relationship between the national EPA to use voluntary consensus [FR Doc. E9–27615 Filed 11–17–09; 8:45 am] standards in its regulatory activities government and the States, or on the BILLING CODE 6560–50–P distribution of power and unless to do so would be inconsistent responsibilities among various levels of with applicable law or otherwise impractical. Voluntary consensus government, as specified in Executive DEPARTMENT OF HEALTH AND standards are technical standards (e.g., Order 13132 (64 FR 43255, August 10, HUMAN SERVICES 1999). This rule proposes to authorize materials specifications, test methods, pre-existing State rules. Thus, Executive sampling procedures, and business 42 CFR Part 84 Order 13132 does not apply to this practices) that are developed or adopted proposed rule. In the spirit of Executive by voluntary consensus bodies. The [Docket Number NIOSH–0137] Order 13132, and consistent with EPA NTTAA directs EPA to provide RIN 0920–AA33 policy to promote communications Congress, through OMB, explanations between EPA and State and local when the Agency decides not to use Total Inward Leakage Requirements governments, EPA specifically solicits available and applicable voluntary for Respirators consensus standards. This proposed comment on this proposed rule from AGENCY: National Institute for State and local officials. rulemaking does not involve technical Occupational Safety and Health standards. Therefore, EPA is not 6. Executive Order 13175: Consultation (NIOSH) of the Centers for Disease considering the use of any voluntary Control and Prevention (CDC), and Coordination With Indian Tribal consensus standards. Governments Department of Health and Human Services (HHS). Executive Order 13175, entitled 10. Executive Order 12898: Federal ‘‘Consultation and Coordination with Actions To Address Environmental ACTION: Notice of proposed rulemaking; Indian Tribal Governments’’ (59 FR Justice in Minority Populations and Low notice of public meeting. Income Populations 22951, November 9, 2000), requires EPA SUMMARY: The National Institute for to develop an accountable process to Executive Order (EO) 12898 (59 FR Occupational Safety and Health ensure ‘‘meaningful and timely input by 7629, February 16, 1994) establishes (NIOSH) of the Centers for Disease tribal officials in the development of Federal executive policy on Control and Prevention (CDC), will hold regulatory policies that have tribal environmental justice. Its main a public meeting concerning the implications.’’ This proposed rule does provision directs Federal agencies, to proposed rule that was published in the not have tribal implications, as specified the greatest extent practicable and Federal Register on Friday, October 30, in Executive Order 13175 because EPA permitted by law, to make 2009. The proposed rule proposes to retains its authority over Indian environmental justice part of their establish total inward leakage (TIL) Country. Thus, Executive Order 13175 mission by identifying and addressing, requirements for half-mask air-purifying does not apply to this proposed rule. as appropriate, disproportionately high particulate respirators approved by EPA specifically solicits additional and adverse human health or NIOSH. The proposed new comment on this proposed rule from environmental effects of their programs, requirements specify TIL minimum tribal officials. policies, and activities on minority performance requirements and testing to 7. Executive Order 13045: Protection of populations and low-income be conducted by NIOSH and respirator Children From Environmental Health populations in the United States. EPA manufacturers to demonstrate that these and Safety Risks has determined that this proposed rule respirators, when selected and used will not have disproportionately high correctly, provide effective respiratory EPA interprets EO 13045 (62 F.R. protection to intended users against 19885, April 23, 1997) as applying only and adverse human health or environmental effects on minority or toxic dusts, mists, fumes, fibers, and to those regulatory actions that concern biological and infectious aerosols (e.g. health or safety risks, such that the low-income populations. This proposed rule does not affect the level of influenza A(H5N1), severe acute analysis required under section 5–501 of respiratory syndrome (SARS) the EO has the potential to influence the protection provided to human health or the environment because this rule coronavirus, and Mycobacterium regulation. This action is not subject to tuberculosis). EO 13045 because it approves a State proposes to authorize pre-existing State program. rules which are equivalent to, and no DATES: Meeting: A public meeting on the less stringent than existing Federal proposed rule will be held on December 8. Executive Order 13211: Actions That requirements. 3, 2009. Details concerning those Significantly Affect Energy Supply, List of Subjects in 40 CFR Part 271 meetings are in the SUPPLEMENTARY Distribution, or Use INFORMATION section below. This proposed rule is not subject to Environmental protection, Comments: As established in the Executive Order 13211, ‘‘Actions Administrative practice and procedure, proposed rule of October 30, 2009 (74 Concerning Regulations that Confidential business information, FR 56141), all written comments must Significantly Affect Energy Supply, Hazardous materials transportation, be received on or before December 29, Distribution, or Use’’ (66 FR 28355, May Hazardous waste, Indians—lands, 2009. 22, 2001) because it is not a ‘‘significant Intergovernmental relations, Penalties, ADDRESSES: You may submit comments, regulatory action’’ as defined under Reporting and recordkeeping identified by RIN: 0920–AA33, by any Executive Order 12866. requirements. of the following methods:
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• Federal eRulemaking Portal: http:// when his/her presentation is scheduled Seafarers, 1978’’ that published in the www.regulations.gov. Follow the to begin, the remaining participants will Federal Register on November 17, 2009. instructions for submitting comments. be heard in order. After the last As stated in that document, the • E-mail: [email protected]. scheduled speaker is heard, participants proposed amendments seek to more Include ‘‘RIN: 0920–AA33’’ and ‘‘42 who missed their assigned times may be fully incorporate the requirements of the CFR Part 84’’ in the subject line of the allowed to speak limited by time International Convention on Standards message. available. Attendees who wish to speak of Training, Certification and • Mail: NIOSH Docket Office, Robert but did not submit a request for the Watchkeeping for Seafarers, 1978, as A. Taft Laboratories, MS–C34, 4676 opportunity to make a presentation may amended (STCW Convention), as well Columbia Parkway, Cincinnati, OH be given this opportunity after the as the Seafarer’s Training, Certification 45226. scheduled speakers are heard, at the and Watchkeeping Code (STCW Code) Instructions: All submissions received discretion of the presiding officer and in the requirements for the credentialing must include the agency name and limited by time available. of United States merchant mariners. docket number or Regulatory This meeting will also be using DATES: Public meetings will be held on Information Number (RIN) for this Audio/LiveMeeting Conferencing, the following dates: rulemaking, RIN: 0920–AA33. All remote access capabilities where • Tuesday, December 1, 2009, in comments received will be posted interested parties may listen in and Miami, FL from 9 a.m. until noon; without change to http://www.cdc.gov/ review the presentations over the • Wednesday, December 2, 2009, in niosh/docket, including any personal internet simultaneously. Parties NY from 9 a.m. until noon; information provided. remotely accessing the meeting will • Wednesday, December 9, 2009, in Docket: For access to the docket to have the opportunity to comment New Orleans, LA from 9 a.m. until read background documents or during the open comment period. To noon; • comments received, go to http:// register to use this capability, please Friday, December 11, 2009, in www.cdc.gov/niosh/docket. contact the National Personal Protective Seattle, WA from 9 a.m. until noon; • Wednesday, January 20, 2010, in FOR FURTHER INFORMATION CONTACT: Technology Laboratory (NPPTL), Policy and Standards Development Branch, Washington, DC from 10 a.m. until 1 Jonathan V. Szalajda, NIOSH, National p.m. Personal Protective Technology Post Office Box 18070, 626 Cochrans Written comments and related material Laboratory (NPPTL), Post Office Box Mill Road, Pittsburgh, PA 15236, may also be submitted to Coast Guard 18070, 626 Cochrans Mill Road, telephone (412) 386–5200, facsimile personnel specified at those meetings Pittsburgh, Pennsylvania 15236, (412) 386–4089. This option will be for inclusion in the official docket for telephone (412) 386–5200, facsimile available to participants on a first come, this rulemaking. The comment period (412) 386–4089, e-mail [email protected]. first serve basis and is limited to the first 50 participants. for the NPRM closes on February 16, SUPPLEMENTARY INFORMATION: The 2010. All comments and related Department of Health and Human Dated: November 6, 2009. material submitted after the meeting Services published a proposed rule on James Stephens, must either be submitted to our online the Total Inward Leakage Requirements Associate Director of Science, Centers for docket via http://www.regulations.gov for Respirators on Friday, October 30, Disease Control and Prevention. on or before February 16, 2010 or reach 2009 (74 FR 56141). [FR Doc. E9–27388 Filed 11–17–09; 8:45 am] the Docket Management Facility by that NIOSH will hold a public meeting on BILLING CODE 4163–19–P date. the proposed rule at the following time ADDRESSES: The public meetings will be and location: December 3, 2009, held at the following locations: beginning at 8:30 a.m. EST and ending DEPARTMENT OF HOMELAND • Tuesday, December 1, 2009, at the at 4 p.m. EST, or after the last public SECURITY Marriott Miami Airport Hotel, 1201 NW commenter has spoken, whichever is LeJeune Road, Miami, FL 33126 from 9 earlier, at the Marriot Inn and Coast Guard a.m. until noon; Conference Center UMUC, 3501 • Wednesday, December 2, 2009, at University Boulevard E., Adelphi, MD 46 CFR Parts 10, 11, 12, and 15 the Marriott New York LaGuardia 20783. [Docket No. USCG–2004–17914] Airport Hotel, 102–05 Ditmars Blvd, Requests to make presentations at the East Elmhurst, NY 11369 from 9 a.m. public meeting should be mailed to the RIN 1625–AA16 until noon; NIOSH Docket Office, Robert A. Taft • Wednesday, December 9, 2009, at Laboratories, MS–C34, 4676 Columbia Implementation of the 1995 the Renaissance Arts Hotel, 700 Parkway, Cincinnati, OH 45226. Amendments to the International Tchoupitoulas Street, New Orleans, LA Requests may also be submitted by Convention on Standards of Training, 70130 from 9 a.m. until noon; telephone (513) 533–8611, facsimile Certification and Watchkeeping for • Friday, December 11, 2009, at the (513) 533–8285, or e-mailed to Seafarers, 1978 Marriott Seattle Airport Hotel, 3201 [email protected]. AGENCY: Coast Guard, DHS. South 176th Street, Seattle, WA 98188 All requests to present should contain ACTION: Notice of public meetings; from 9 a.m. until noon; • Wednesday, January 20, 2010, at the name, address, telephone number request for comments. and relevant business affiliations of the United States Coast Guard Headquarters presenter, and the approximate time SUMMARY: The Coast Guard announces a Building, Room 2415, 2100 Second requested for the presentation. Oral series of public meetings to receive Street, SW., Washington, DC 20593 from presentations should be limited to 15 comments on a notice of proposed 10 a.m. until 1 p.m. Note: A minutes. rulemaking (NPRM) entitled government-issued photo identification After reviewing the requests for ‘‘Implementation of the 1995 (for example, a driver’s license) will be presentations, NIOSH will notify the Amendments to the International required for entrance to the building. presenter that his/her presentation is Convention on Standards of Training, Live Webcasts (audio and video) of the scheduled. If a participant is not present Certification and Watchkeeping for four public meetings to be held in
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Miami, FL, New York, NY, New as the Seafarer’s Training, Certification DEPARTMENT OF TRANSPORTATION Orleans, LA, and Seattle, WA, will also and Watchkeeping Code (STCW Code) be broadcast online. The Web site for in the requirements for the credentialing National Highway Traffic Safety viewing those Webcasts can be found at of United States merchant mariners. Administration http://www.stcwregs.us. The Webcasts You may view the NPRM in our will enable those using this feature only online docket, in addition to supporting 49 CFR Part 580 to view the proceedings and not to make documents prepared by the Coast [Docket No. NHTSA–2009–0174; Notice 1] remarks to those participating in the Guard, and comments submitted thus meetings in person. However, a far by going to http:// Petition for Approval of Alternate verbatim record of these public www.regulations.gov. Once there, click Odometer Disclosure Requirements meetings will be provided in the docket. on the ‘‘Read Comments’’ box. In the You may submit written comments ‘‘Enter Keyword or ID’’ box, insert AGENCY: National Highway Traffic identified by docket number USCG– ‘‘USCG–2004–17914’’ and click search. Safety Administration (NHTSA), DOT. 2004–17914 before or after the meetings Click the ‘‘Open Docket Folder’’ button ACTION: Notice of initial determination. using any one of the following methods: in the ‘‘Actions’’ column. If you do not (1) Federal eRulemaking Portal: have access to the internet, you may SUMMARY: The State of Texas has http://www.regulations.gov. view the docket online by visiting the petitioned for approval of alternate (2) Fax: 202–493–2251. Docket Management Facility in Room requirements to certain requirements (3) Mail: Docket Management Facility W12–40 on the ground floor of the under Federal odometer law. NHTSA (M–30), U.S. Department of Department of Transportation West has initially determined that Texas’s Transportation, West Building Ground Building, 1200 New Jersey Avenue, SE., alternate requirements satisfy Federal Floor, Room W12–140, 1200 New Jersey Washington, DC 20590, between 9 a.m. odometer law, with limited exceptions. Avenue, SE., Washington, DC 20590– and 5 p.m., Monday through Friday, Accordingly, NHTSA has preliminarily 0001. except Federal holidays. We have an decided to grant Texas’s petition, on the (4) Hand delivery: Same as mail agreement with the Department of condition that before NHTSA makes a address above, between 9 a.m. and 5 Transportation to use the Docket final determination, Texas amends its p.m., Monday through Friday, except Management Facility. program to meet all the requirements of Federal holidays. The telephone number We encourage you to participate in Federal odometer law or demonstrates is 202–366–9329. this rulemaking by submitting that it meets the requirements of Federal To avoid duplication, please use only comments either orally at the meetings law. This notice is not a final agency one of these four methods. Our online or in writing. If you bring written action. docket for this rulemaking is available comments to the meetings, you may DATES: Comments are due no later than on the Internet at http:// submit them to Coast Guard personnel December 18, 2009. www.regulations.gov under docket specified at the meeting to receive ADDRESSES: You may submit comments number USCG–2004–17914. written comments. These comments [identified by DOT Docket ID Number FOR FURTHER INFORMATION CONTACT: If will be submitted to our online public NHTSA–2008–0116] by any of the you have questions on this proposed docket. All comments received will be following methods: rulemaking, call or e-mail Mr. Mark posted without change to http:// • Federal eRulemaking Portal: Go to Gould, Maritime Personnel www.regulations.gov and will include http://www.regulations.gov. Follow the Qualifications Division, U.S. Coast any personal information you have online instructions for submitting Guard, telephone 202–372–1409, e-mail: provided. comments. [email protected]. If you have Anyone can search the electronic • Mail: Docket Management Facility: questions on viewing or submitting form of comments received into any of U.S. Department of Transportation, 1200 material to the docket, call Ms. Renee V. our dockets by the name of the New Jersey Avenue SE., West Building Wright, Program Manager, Docket individual submitting the comment (or Ground Floor, Room W12–140, Operations, telephone 202–366–9826. signing the comment, if submitted on Washington, DC 20590–0001. behalf of an association, business, labor SUPPLEMENTARY INFORMATION: • Hand Delivery or Courier: West union, etc.). You may review a Privacy Building Ground Floor, Room W12–140, Background and Purpose Act notice regarding our public dockets 1200 New Jersey Avenue SE., between The Coast Guard published a notice of in the January 17, 2008, issue of the 9 a.m. and 5 p.m. ET, Monday through proposed rulemaking (NPRM) in the Federal Register (73 FR 3316). Friday, except Federal holidays. Federal Register on November 17, 2009, Information on Service for Individuals • Fax: 202–493–2251. entitled ‘‘Implementation of the 1995 With Disabilities Instructions: For detailed instructions Amendments to the International For information on facilities or on submitting comments and additional Convention on Standards of Training, services for individuals with disabilities information on the rulemaking process, Certification and Watchkeeping for or to request special assistance at the see the Public Participation heading of Seafarers, 1978.’’ In the NPRM, we public meetings, contact Mr. Mark the SUPPLEMENTARY INFORMATION section stated our intention to hold public Gould at the telephone number or of this document. Note that all meetings and to publish a notice e-mail address indicated under the FOR comments received will be posted announcing the location and date. This FURTHER INFORMATION CONTACT section of without change to http:// document is the notice of those this notice. www.regulations.gov, including any meetings. personal information provided. Please In the NPRM, we seek to more fully Dated: November 12, 2009. see the Privacy Act heading below. incorporate the requirements of the J.G. Lantz, Privacy Act: Anyone is able to search International Convention on Standards Director of Commercial Regulations and the electronic form of all comments of Training, Certification and Standards, U.S. Coast Guard. received into any of our dockets by the Watchkeeping for Seafarers, 1978, as [FR Doc. E9–27639 Filed 11–17–09; 8:45 am] name of the individual submitting the amended (STCW Convention), as well BILLING CODE 9110–04–P comment (or signing the comment, if
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submitted on behalf of an association, alternate odometer disclosure safeguards for the protection of business, labor union, etc.). You may requirements under TIMA. The Texas purchasers with respect to the sale of review DOT’s complete Privacy Act Department of Transportation proposes motor vehicles having altered or reset Statement in the Federal Register a paperless electronic title transfer odometers. See Public Law 92–513, published on April 11, 2000 (65 FR scheme. Texas’ program is similar to the section 401, 86 Stat. 947, 961–63 (1972). 19477–78) or you may visit http:// Commonwealth of Virginia’s alternate The Cost Savings Act required that the DocketInfo.dot.gov. odometer disclosure program, which, transferor of a motor vehicle provide a Docket: For access to the docket to after notice and comment, NHTSA written vehicle mileage disclosure to the read background documents or approved on January 2, 2009. 74 FR 643, transferee, included several provisions comments received, go to http:// 650 (January 7, 2009). Similar to relating to tampering with odometers www.regulations.gov or the street Virginia’s, Texas’s proposal does not and provided for enforcement. See address listed above. Follow the online implicate the provisions of federal Public Law 92–513, section 408, 86 Stat. instructions for accessing the dockets. odometer law related to leased vehicles, 947 (1972).6 In general, the purpose for FOR FURTHER INFORMATION CONTACT: disclosures by power of attorney where the disclosure was to assist purchasers Andrew DiMarsico, Office of the Chief the title is held by a lien holder, or to know the true mileage of a motor Counsel, National Highway Traffic transactions involving at least one out- vehicle. Safety Administration, 1200 New Jersey of-State party. A major shortcoming of the odometer Avenue, SE., Washington, DC 20590 As discussed below, NHTSA’s initial provisions of the Cost Savings Act was (Telephone: 202–366–5263) (Fax: 202– assessment is that the Texas program that they did not require that the 366–3820). satisfies the requirements for approval odometer disclosure statement be on the SUPPLEMENTARY INFORMATION: under Federal odometer law, if Texas title. In a number of States, they were amends its program to or shows that its on separate documents that could be I. Introduction program provides for a transferee to altered easily or discarded and did not Federal odometer law, which is obtain a paper title that complies with travel with the title. See 74 FR 644. largely based on the Motor Vehicle the requirements of TIMA,3 incorporates Consequently, the disclosure statements Information and Cost Savings Act (Cost the ‘‘brand’’ requirement in its did not deter odometer fraud employing Savings Act) 1 and Truth in Mileage Act electronic titling process (the brand altered documents, discarded titles, and of 1986 (TIMA),2 contains a number of states whether the odometer reflects the title washing. Id. provisions to limit odometer fraud and actual mileage, reflects the mileage in Congress enacted TIMA in 1986 to assure that the purchaser of a motor excess of the designated odometer limit address the Cost Savings Act’s vehicle knows the true mileage of the or differs from the actual mileage and shortcomings. It amended the Cost vehicle. Under regulations promulgated should not be relied upon) 4 and Savings Act to prohibit States from pursuant to provisions in the Cost requires dealers to satisfy their licensing vehicles after transfers of Savings Act, the transferor (seller) of a obligation under Federal law to retain ownership unless the new owner motor vehicle must provide a written copies of odometer disclosure (transferee) submitted a title from the statement of the vehicle’s mileage, statements that they issue or receive.5 seller (transferor) containing the seller’s signed and dated by the transferor, to This notice proposes that NHTSA signed and dated statement of the the transferee (buyer) at the time of sale. conditionally grant the Texas petition, vehicle’s mileage, as previously This written statement is generally subject to its resolution of these three required by the Cost Savings Act. See referred to as the odometer disclosure concerns to NHTSA’s satisfaction. Public Law 99–579, 100 Stat. 3309 (1986); 74 FR 644 (Jan. 7, 2009). TIMA statement. Further, under TIMA, vehicle II. Statutory Background titles themselves must have a space for also prohibits the licensing of vehicles, the odometer disclosure statement and NHTSA recently reviewed the for use in any State, unless the title States are prohibited from licensing statutory background of Federal issued to the transferee is printed using vehicles if the odometer disclosure odometer law in its consideration and a secure printing process or other secure statement on the title is not signed and approval of Virginia’s petition for process, indicates the vehicle mileage at dated by the transferor. In addition, alternate odometer disclosure the time of transfer and contains titles must be printed by a secure requirements. See 73 FR 35617 (June 24, additional space for a subsequent printing process or other secure process. 2008) and 74 FR 643 (January 7, 2009). mileage disclosure by the transferee TIMA also contains specific disclosure The statutory background of the Cost when it is sold again. Id. Other provisions on transfers of leased Savings Act and TIMA, and the provisions created similar safeguards for vehicles. Federal law also contains purposes behind TIMA, are discussed at leased vehicles. document retention requirements. length in NHTSA’s Final Determination TIMA’s requirements respecting the granting Virginia’s petition. 74 FR 643, 6 Section 408 stated: disclosure of motor vehicle mileage 647–48. A brief summary of the (a) Not later than 90 days after the date of statutory background of Federal enactment of this Act, the Secretary shall prescribe when vehicles are transferred or leased rules requiring any transferor to give the following apply in a State unless the State has in odometer law and the purposes of TIMA written disclosure to the transferee in connection effect alternative requirements approved follows. with the transfer of ownership of a motor vehicle: by NHTSA. A State may petition In 1972, Congress enacted the Cost (1) Disclosure of the cumulative mileage NHTSA for the approval of alternate Savings Act, among other things, to registered on the odometer. prohibit tampering of odometers on (2) Disclosure that the actual mileage is unknown, odometer disclosure requirements that if the odometer reading is known to the transferor apply in lieu of the Federal odometer motor vehicles and to establish certain to be different from the number of miles the vehicle requirements. has actually traveled. Seeking to implement an electronic 3 See Section 408(d)(2)(A)(i) of the Cost Savings Such rules shall prescribe the manner in which vehicle title transfer system, the State of Act, as added by TIMA, recodified at 49 U.S.C. information shall be disclosed under this section 32705(b)(3)(A)(i) and 49 CFR 580.4. Texas has petitioned for approval of and in which such information shall be retained. 4 See Section 408 of the Cost Savings Act, (b) It shall be a violation of this section for any recodified at 49 U.S.C. 32705, and 49 CFR 580.5(e). transferor to violate any rules under this section or 1 Public Law 92–513, 86 Stat. 947, 961 (1972). 5 See Section 408 of the Cost Savings Act, to knowingly give a false statement to a transferee 2 Public Law 99–579, 100 Stat. 3309 (1986). recodified at 49 U.S.C. 32705, and 49 CFR 580.8. in making any disclosure required by such rules.
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TIMA added a provision to the Cost 408(f)(2) of the Cost Savings Act context of paper titles, under TIMA, the Savings Act, allowing States to have (recodified in 1994 to 49 U.S.C. title must be set forth by means of a alternate requirements to those required 32705(d)) provides that NHTSA ‘‘shall secure printing process or protected by under TIMA respecting the disclosure of approve alternate motor vehicle mileage ‘‘other secure process.’’ 9 Id. mileage, with the approval of the disclosure requirements submitted by a Another purpose was to create a Secretary of Transportation. It amended State unless [NHTSA] determines that record of the mileage on vehicles and a Section 408 of the Cost Savings Act as such requirements are not consistent paper trail. 74 FR 648. The underlying follows: with the purpose of the disclosure purposes of this record and paper trail (f)(1) The requirements of subsections (d) required by subsection (d) or (e) as the were to enable consumers to be better and (e)(1) respecting the disclosure of motor case may be.’’ (Subsections 408(d), (e) of informed and provide a mechanism vehicle mileage when motor vehicles are the Cost Savings Act were recodified to through which odometer tampering can transferred or leased shall apply in a State 49 U.S.C. 32705(b) and (c)). In light of be traced and violators prosecuted. unless the State has in effect alternate motor this provision, we now turn to our TIMA’s requirement that new vehicle mileage disclosure requirements interpretation of the purposes of these applications for titles include the prior approved by the Secretary. The Secretary owner’s signed mileage disclosure may promulgate regulations establishing subsections, as germane to Texas’s 7 procedures for the consideration and petition. statement on his or her title creates a approval of such alternate requirements. Our Final Determination granting permanent record that is easily checked (2) The Secretary shall approve alternate Virginia’s petition for alternate by subsequent owners or law motor vehicle mileage disclosure odometer disclosure requirements, after enforcement officials. This record requirements submitted by a State unless the notice and comment, identified the provides critical snapshots of the Secretary determines that such requirements purposes of TIMA germane to petitions vehicle’s mileage at every transfer, are not consistent with the purpose of the for approval of certain alternate which are the fundamental links of this disclosure required by subsection (d) or (e), 8 as the case may be. odometer disclosure requirements. 74 paper trail. FR 643, 647–48 (January 7, 2009). These Finally, the general purpose of TIMA In 1988, Congress amended section purposes are summarized below. was to protect consumers by assuring 408(d) of the Cost Savings Act to permit One purpose of TIMA was to assure that they received valid representations the use of a secure power of attorney in that the form of the odometer disclosure of the vehicle’s actual mileage at the circumstances where the title was held precluded odometer fraud. 74 FR 647. time of transfer based on odometer by a lienholder. The Secretary was To prevent odometer fraud facilitated by disclosures. Id. required to publish a rule to implement disclosure statements that were separate IV. The Texas Petition the provision. See Public Law 100–561 from titles, TIMA required mileage section 40, 102 Stat. 2805, 2817 (1988), disclosures to be on a secure vehicle Because it seeks to implement an which added Section 408(d)(2)(C). In title instead of a separate document. electronic title transfer system, Texas 1990, Congress amended section These titles also had to contain space for petitions for approval of alternate 408(d)(2)(C) of the Cost Savings Act. the seller’s attested mileage disclosure odometer disclosure requirements. The The amendment addressed retention of and a new disclosure by the purchaser scope of its petition is limited; Texas powers of attorneys by States and when the vehicle was sold again. This does not request alternate disclosure provided that the rule adopted by the discouraged mileage alterations on titles requirements for leased vehicles, Secretary not require that a vehicle be and limited opportunities for obtaining disclosures of odometer statements by titled in the State in which the power new titles with lower mileage than the power of attorney, such as for vehicles of attorney was issued. See Public Law actual mileage. Id. subject to a lien, or transactions 101–641 section 7(a), 104 Stat. 4654, A second purpose of TIMA was to involving at least one out-of-State party. 4657 (1990). prevent odometer fraud by processes Texas proposes maintaining In 1994, in the course of the and mechanisms making the disclosure electronic records of titles in the Texas recodification of various laws pertaining of an odometer’s mileage on the title a Department of Transportation (TxDOT), to the Department of Transportation, the condition of the application for a title, Division of Vehicle Title and Cost Savings Act, as amended, was and a requirement for the title issued by Registration (VTR) computer system. repealed, reenacted and recodified the State. 74 FR 647. This provision was According to Texas’s petition, the without substantive change. See Public intended to eliminate or significantly ‘‘title’’ will reside as an electronic Law 103–272, 108 Stat. 745, 1048–1056, reduce abuses associated with lack of record with the TxDOT, but that ‘‘hard’’ 1379, 1387 (1994). The odometer statute control of the titling process. Id. copies of the title can be generated if is now codified at 49 U.S.C. 32701 et Third, TIMA sought to prevent needed. seq. In particular, Section 408(a) of the alterations of disclosures on titles and to The petition also states that the Cost Savings Act was recodified at 49 preclude counterfeit titles through proposed system would require sellers U.S.C. 32705(a). Sections 408(d) and (e), secure processes. 74 FR 648. In to accurately disclose vehicle mileage which were added by TIMA (and later furtherance of these purposes, in the and allow buyers to record, view and amended), were recodified at 49 U.S.C. acknowledge receipt of the disclosure 32705(b) and (c). The provisions 7 Texas’s petition does not address disclosures in through a secure on-line transaction pertaining to approval of State alternate leases or disclosures by power of attorney. In view motor vehicle mileage disclosure of the scope of Texas’s petition, Texas will continue 9 Congress intended to encourage new requirements were recodified at 49 to be subject to current federal requirements as to technologies by including the language ‘‘other leases and disclosures by power of attorney, and we secure process.’’ The House Report accompanying U.S.C. 32705(d). do not address the purposes of the related TIMA noted that ‘‘‘other secure process’ is intended III. Statutory Purposes provisions. to describe means other than printing which could 8 Since Virginia’s program did not cover securely provide for the storage and transmittal of As discussed above, the Cost Savings disclosures in leases or disclosures by power of title and mileage information.’’ H.R. Rep. No. 99– Act, as amended by TIMA in 1986, attorney, the purposes of Sections 408(d)(2)(C) and 833, at 33 (1986). ‘‘In adopting this language, the 408(e) of the Cost Savings Act, as amended, were Committee intends to encourage new technologies contains a specific provision on not germane and were not addressed in the notice which will provide increased levels of security for approval of State alternate odometer approving the Virginia program. See 74 FR 647 n. titles.’’ Id. See also Cost Savings Act, as amended disclosure programs. Subsection 12. by TIMA, § 408(d), recodified at 49 U.S.C. 32705(b).
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with TxDOT using the TexasOnline ownership transaction. Meanwhile, the authorization number and the dealer Authentication Service (TOAS). TOAS VTR system would automatically check number. is described as a secure identity the odometer reading entered by the Texas’s petition asserts that its verification service that establishes transferor against VTR odometer proposed alternate odometer disclosure electronic signatures by authenticating records. If the odometer reading entered is consistent with Federal odometer law. individuals against a database. TOAS by the transferor is lower than in the As advanced by TxDOT, Texas’s allows TexasOnline to collect user data, State’s records, the transaction will be alternative ensures that a fraudulent which it matches four personal data immediately rejected. elements and two forms of identification odometer disclosure can readily be Once transferees log on to submitted by the user against the detected and reliably traced to a TexasOnline and are authenticated, TexasOnline Authentication Database particular individual by providing a TOAS will transfer them to the TxDOT (TOAD) 10 to authenticate and verify the means for TxDOT to validate and VTR system where they can select identity of the user. TOAD data authenticate the individuals through the elements include: A Texas driver ‘‘vehicle transfer of ownership’’ and electronic signatures of both parties. As license or identification card number; enter the unique transaction number described above, the parties’ electronic current driver license or identification obtained from the transferor. The signatures are established and their card audit number; date of birth; and the transferee must enter the correct identities authenticated through the four last four digits of the individual’s social transaction number to continue. Once TOAD data elements, Texas driver’s access is obtained, the transferee would security number. license, driver’s license audit number, verify the sales price and odometer A purchaser or seller cannot access date of birth and last four digits of social reading entered by the transferor. If all the proposed electronic title system security number. TOAS then verifies the the data entered by the transferor is unless the purchaser’s or seller’s identity of the transferor and transferee identity, and status as a Texas resident, verified and acknowledged as correct by the transferee, ownership of the vehicle through the submission of the required holding a valid Texas driver’s license or information. To conduct any identification card, is authenticated by would pass to the transferee and an transaction, both the transferor and TOAS. Therefore, the Texas petition electronic title record would be transferee will have to authenticate their asserts that out-of-state parties would be established by the VTR system. The unable to initiate an electronic title VTR system would then contact the identity by submitting the correct data transfer in an on-line transaction with transferor and request that the elements. TxDOT. transferor’s original paper title be Texas also asserts that its proposal Under Texas’s proposal, completing a mailed to the VTR for destruction.12 provides a level of security equivalent to motor vehicle sale would require that If the transferee does not agree with that of a disclosure on a secure title the seller (transferor) and the purchaser the information entered by the document and provides an on-line (transferee) perform several steps. First, transferor, then the VTR system will authentication for identity management the seller’s identity must be reject the transaction. The transferor solution in lieu of an actual signature on authenticated using TOAS. Once will have the opportunity to correct the the title. Furthermore, Texas states that authenticated, the seller can access the sales price and odometer reading for the the electronic odometer disclosure TxDOT VTR Registration and Titles rejected transaction. The transferee provided by the transferor will be System (VTR system). The seller then would then re-verify the information to available to the transferee at the time selects a ‘‘transfer of ownership’’ ensure the accuracy. A second ownership of the vehicle is transferred. transaction and enters the Vehicle Identification Number (VIN). The discrepancy would result in The Texas petition maintains that the vehicle’s information is automatically cancellation of the electronic electronic record and signature populated on the screen. The transferor transaction. components of the proposal comport is prompted to enter the vehicle sales Texas’s petition states that the same with the Electronic Signatures in Global price and odometer reading.11 After process, along with additional and National Commerce Act (E-Sign), 15 entering this data, the VTR system will safeguards, will be used in dealer U.S.C. 7001 et seq. Current State law provide the transferor with a unique assignments and reassignments of permits the creation of electronic transaction number. The transferor must vehicle ownership. According to Texas, certificates of title, but requires a paper provide the unique transaction number such safeguards include requiring the certificate of title for all transfers of to the transferee to complete the dealership to notify VTR of the vehicle ownership. Tex. Transp. Code transaction. employees authorized to do titling Ann. § 501.117. If its proposal were The transaction would remain in activities for the dealership.13 This approved, Texas could pass pending ‘‘pending’’ status until the transferee authorization will be stored in the legislation that would implement an logs on to complete the transfer of TxDOT VTR system. To complete a electronic title system. transaction, the authorized employee 10 Currently, TexasOnline permits users to will be required to enter his or her V. Analysis perform several services online, such as renewal of driver licenses, voter registration address changes, Under TIMA, NHTSA ‘‘shall approve 12 and ordering driving records. The term ‘‘electronic According to the Texas petition, the previous alternate motor vehicle mileage signature’’ means an electronic sound, symbol or title, regardless if it were electronic or paper, would process, attached to or logically associated with a be superseded by the ‘‘new’’ electronic title. The disclosure requirements submitted by a contract or other record and executed or adopted by ‘‘old’’ title is invalidated in the VTR system and State unless [NHTSA] determines that a person with the intent to sign the record. 15 would be unable to transfer title in Texas. such requirements are not consistent U.S.C. 7006(5) (2004). 13 Texas does not address the dealer retention 11 Texas does not address the brand requirement. requirements as set forth in 49 CFR 580.8(a), which with the purpose of the disclosure Under the Cost Savings Act, a person transferring requires dealers and distributors to retain a copy of required by subsection (d) or (e) as the ownership must provide written disclosure that the odometer disclosure statements that they issue and case may be.’’ The purposes are actual mileage is unknown, if the transferor knows receive for five years. It is unclear whether Texas’s discussed above, as is the Texas that the odometer reading is different from the program includes a mechanism for the dealer or number of miles the vehicle has actually traveled. distributor to retain a copy of any odometer alternative. We now provide our initial See 49 CFR 590.5(e). disclosure statement involved in a transaction. assessment whether Texas’s proposal
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satisfies TIMA’s purposes as relevant to electronic version of the title until the creating a paper trail since the VTR its petition.14 transferee requests it. system will have histories of odometer One purpose is to assure that the form Under the VTR system, all subsequent disclosures for each title transfer. These of the odometer disclosure precludes transfers may be performed through the electronic records will create the odometer fraud. In this regard, NHTSA on-line process. Each time an on-line electronic equivalent to a paper based has initially determined that Texas’s transfer occurs, the VTR system stores system that will be readily available to proposed alternate disclosure the electronic version of the title, and law enforcement. The one exception is requirements satisfy this purpose. issues a paper title only upon request. that the program does not require Under Texas’s proposal, it appears that Since the title remains in electronic dealers to retain a copy of all odometer the ‘‘title’’ will reside as an electronic form under State care and custody, the disclosures that they issue and receive. record with the TxDOT, but a hard copy likelihood of an individual altering, Finally, TIMA’s overall purpose is to of the title will be generated upon tampering or counterfeiting the title is protect consumers by assuring that they request. Texas’s proposed system will, significantly decreased. These electronic receive valid representations of the therefore, continue to have the odometer records are maintained in a secure vehicle’s actual mileage at the time of disclosure on the virtual ‘‘title’’ itself, as environment and any attempted transfer based on odometer disclosures. required by TIMA, and not as a separate alteration would be detected by the Here, Texas’s proposed alternate document. As to TIMA’s requirement system. Finally, if a transferee requests disclosure requirements include several that the title contain a space for the a paper title, the VTR will issue a paper characteristics that would assure that transferor to disclose the vehicle’s title, but the Texas submission does not representations of a vehicle’s actual mileage, NHTSA does not believe the state that the paper title will comply mileage would be as valid as those proposed Texas electronic title is with TIMA requirements, which it must. found in current paper title transfers, inconsistent with the space Another purpose of TIMA is to create with one exception. These requirement. The agency, however, a record of the mileage on vehicles and characteristics include identity and expects that hard copies of these a paper trail. The underlying purposes residency authentication, an automatic electronic titles will provide a separate of this record trail are to enable system check of the reported mileage space for owners to execute a proper consumers to be better informed and against previously reported mileage, and odometer disclosure in keeping with provide a mechanism through which transferee verification of the data TIMA and current practice. odometer tampering can be traced and reported by the transferor.17 In addition, Another purpose of TIMA is to violators prosecuted. In NHTSA’s by providing rapid access to records of prevent odometer fraud by processes preliminary view, the proposed past transfers, the scheme proposed by and mechanisms making the disclosure electronic title transfer system will Texas could potentially provide of an odometer’s mileage on the title a create a scheme of records equivalent to superior deterrence to odometer fraud condition of the application for a title the current ‘‘paper trail’’ now assisting when compared to the current paper and a requirement for the title issued by law enforcement in identifying and title system. The one exception is that the State. NHTSA has initially prosecuting odometer fraud. Under the Texas’s alternate disclosure determined that Texas’s proposed Texas proposal, creation of a paper trail requirements do not require the process satisfies this purpose. The starts with the establishment of the transferor to state whether the odometer proposed on-line title transfer process electronic signatures of the parties. Due reflects the actual mileage or if the requires disclosure of odometer to the system’s procedures for validating actual mileage is unknown. See 49 CFR information before the transaction can and authenticating the electronic 580.5(e). This statement is referred to as be completed. If the transaction is signature of each individual through the ‘‘brand.’’ successful, the VTR system will retain TOAS and TOAD, the electronic an electronic title, which includes a signatures of the transferor and VI. NHTSA’s Initial Determination record of the transaction and the transferee are reliable, readily detectable For the foregoing reasons, NHTSA odometer disclosure information. Once and can easily be linked to particular preliminarily grants Texas’s proposed the transaction is complete, transferors individuals.16 Because the electronic alternate disclosure requirements on the are instructed to mail the existing title signature consists of data elements such condition that Texas amends its to the VTR for destruction.15 as the Texas driver license or program to enable transferees to obtain Another purpose of TIMA is to identification card number, driver a paper copy of the title that meets the prevent alterations of disclosures on license or identification card audit requirements of TIMA, requires dealers titles and to preclude counterfeit titles number, date of birth and last four digits to retain a copy of all odometer through secure processes. The agency of the individual’s social security disclosures that they issue and receive, has initially determined that VTR’s number, the VTR system can validate and requires disclosure of the brand, or alternate disclosure requirements and authenticate individual electronic demonstrates that these requirements appear to be as secure as current paper signatures. This authentication process are met. This is not a final agency titles. Electronic recording of odometer also allows the VTR system to trace the action. NHTSA invites public comments readings and disclosures decreases the individuals involved in the transaction. within the scope of this notice. Should likelihood of any subsequent odometer This capacity maintains the purposes of NHTSA decide to issue a final grant of disclosure being altered by erasures or Texas’ petition, it would likely reserve other methods. As we understand 16 Electronic signatures are generally valid under the right to rescind that grant in the Texas’s proposal, once the transaction is applicable law. Congress recognized the growing event that information acquired after completed, the VTR system stores an importance of electronic signatures in interstate commerce when it enacted the Electronic Signatures in Global and National Commerce Act 17 Further protection is provided by the VTR 14 Texas would continue to be subject to all (E-Sign). See Public Law 106–229, 114 Stat. 464 system itself. The system automatically cross federal requirements that are not based on Section (2000). E-Sign established a general rule of validity references the odometer reading entered by the 408(d) of the Cost Savings Act as amended, for electronic records and electronic signatures. 15 transferor against the odometer reading on the VTR recodified at 49 U.S.C. 32705(b). U.S.C. 7001. It also encourages the use of electronic system. If the odometer reading entered by the 15 If the transferor does not return the existing signatures in commerce, both in private transferor is lower than the mileage recorded in the title to VTR, the existing title will be invalid once transactions and transactions involving the Federal VTR system, the VTR system will immediately the vehicle transfers to the transferee. government. 15 U.S.C. 7031(a). reject the transaction.
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that grant were to indicate that, in Will The Agency Consider Late operating in state and Federal waters in operation, Texas alternate requirements Comments? the Atlantic Ocean, Gulf of Mexico, and do not satisfy applicable standards. We will consider all comments that Pacific Ocean that would be required to take observers upon NMFS’ request. The Request for Comments Docket Management receives before the close of business on the comment purpose of observing identified fisheries How Do I Prepare and Submit closing date indicated above under is to learn more about sea turtle Comments? DATES. To the extent possible, we also interactions in a given fishery, evaluate will consider comments that Docket existing measures to reduce or prevent Your comments must be written and sea turtle takes, and to determine in English. To ensure that your Management receives after that date. If Docket Management receives a comment whether additional measures to address comments are filed correctly in the prohibited sea turtle takes may be Docket, please include the docket too late for us to consider it in developing the final rule, we will necessary. Fisheries identified through number of this document in your this process would remain on the AD, comments. consider that comment as an informal suggestion for future rulemaking action. and therefore required to carry observers Your comments must not be more upon NMFS’ request, for 5 years. than 15 pages long (see 49 CFR 553.21). How Can I Read the Comments DATES: Comments must be received by We established this limit to encourage Submitted by Other People? December 18, 2009. you to write your primary comments in ADDRESSES: a concise fashion. However, you may You may read the comments received Send comments on the attach necessary additional documents by Docket Management at the address proposed rule by any one of the to your comments. There is no limit on given under ADDRESSES. The hours of following methods. (1) Electronic Submissions: Submit all the length of the attachments. the Docket are indicated above in the same location. electronic comments through the Please submit two copies of your You also may see the comments on Federal eRulemaking portal: http:// comments, including the attachments, the Internet. To read the comments on www.regulations.gov (follow to Docket Management at the address the Internet, go to http:// instructions for submitting comments). given under ADDRESSES. www.regulations.gov, and follow the (2) Facsimile: (301) 713–0376, You may also submit your comments instructions for accessing the Docket. Attention: 2010 Sea Turtle Annual to the docket electronically by logging Please note that even after the Determination. onto the Dockets Management System comment closing date, we will continue (3) Mail: Chief, Marine Mammal and Web site at http://dms.dot.gov. Click on to file relevant information in the Sea Turtle Conservation Division, Office ‘‘Help & Information,’’ or ‘‘Help/Info’’ to Docket as it becomes available. Further, of Protected Resources, NMFS, 1315 obtain instructions for filing the some people may submit late comments. East-West Highway, Silver Spring, MD document electronically. Accordingly, we recommend that you 20910. Instructions: All comments received How Can I Be Sure That My Comments periodically check the Docket for new are a part of the public record and will Were Received? material. generally be posted to http:// Issued on: November 6, 2009. If you wish Docket Management to www.regulations.gov without change. notify you upon its receipt of your O. Kevin Vincent, All personal identifying information (for comments, enclose a self-addressed, Chief Counsel. example, name, address, etc.) stamped postcard in the envelope [FR Doc. E9–27157 Filed 11–17–09; 8:45 am] voluntarily submitted by the commenter containing your comments. Upon BILLING CODE 4910–59–P may be publicly accessible. Do not receiving your comments, Docket submit confidential business Management will return the postcard by information or otherwise sensitive or mail. DEPARTMENT OF COMMERCE protected information. NMFS will accept anonymous comments (enter How Do I Submit Confidential Business National Oceanic and Atmospheric ‘‘N/A’’ in the required fields, if you Information? Administration wish to remain anonymous). If you wish to submit any information Attachments to electronic comments under a claim of confidentiality, you 50 CFR Part 222 will be accepted in Microsoft Word, should submit three copies of your [Docket No. 0906181067–91356–01] Excel, WordPerfect, or Adobe PDF file complete submission, including the formats only. information you claim to be confidential RIN 0648–XP96 Send comments on the information collection requirements or any other business information, to the Chief 2010 Annual Determination for Sea aspects of the collection of information Counsel, NHTSA, at the address given Turtle Observer Requirement above under FOR FURTHER INFORMATION to the Chief of the Marine Mammal and CONTACT. In addition, you should AGENCY: National Marine Fisheries Sea Turtle Conservation Division, Office submit two copies, from which you Service (NMFS), National Oceanic and of Protected Resources, at the have deleted the claimed confidential Atmospheric Administration (NOAA), ADDRESSES above, and e-mail to business information, to Docket Commerce. [email protected], or fax to Management at the address given above ACTION: Proposed rule. (202) 395–7285. under ADDRESSES. When you send a See SUPPLEMENTARY INFORMATION for a comment containing information SUMMARY: The National Marine listing of all Regional Offices. claimed to be confidential business Fisheries Service (NMFS) publishes its FOR FURTHER INFORMATION CONTACT: information, you should include a cover proposed Annual Determination (AD) Kristy Long, Office of Protected letter setting forth the information for 2010, pursuant to its authority under Resources, 301–713–2322; Ellen Keane, specified in our confidential business the Endangered Species Act (ESA). Northeast Region, 978–282–8476; information regulation (49 CFR Part Through this proposed AD, NMFS Dennis Klemm, Southeast Region, 727– 512). would identify commercial fisheries 824–5312; Elizabeth Petras, Southwest
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Region, 562–980–3238; Kim Maison, Section 9 of the ESA prohibits the take occurring; to evaluate whether existing Pacific Islands Region, 808–944–2257. (including harassing, harming, measures are minimizing or preventing Individuals who use a pursuing, hunting, shooting, wounding, takes; and to determine whether telecommunications device for the killing, trapping, capturing, or collecting additional measures are needed to hearing impaired may call the Federal or attempting to engage in any such implement ESA take prohibitions and Information Relay Service at 1–800– conduct), including incidental take, of conserve turtles. 877–8339 between 8 a.m. and 4 p.m. endangered sea turtles. Pursuant to Process for Developing an Annual Eastern time, Monday through Friday, section 4(d) of the ESA, NMFS has Determination excluding Federal holidays. issued regulations extending the SUPPLEMENTARY INFORMATION: prohibition of take, with exceptions, to Pursuant to 50 CFR 222.402, the threatened sea turtles (50 CFR 223.205 Assistant Administrator for Fisheries, Availability of Published Materials and 223.206). Section 11 of the ESA NOAA (AA), in consultation with Information regarding the Marine authorizes the issuance of regulations to Regional Administrators and Fisheries Mammal Protection Act (MMPA) List of enforce the take prohibitions. NMFS Science Center Directors, develops a Fisheries (LOF) may be obtained at may grant exceptions to the take proposed annual determination http://www.nmfs.noaa.gov/pr/ prohibitions with an incidental take identifying which fisheries are required interactions/lof/ and information statement or an incidental take permit to carry observers, if requested, to regarding Marine Mammal Stock issued pursuant to ESA section 7 or 10, monitor potential interactions with sea Assessment Reports may be obtained at respectively. To do so, NMFS must turtles. NMFS provides an opportunity http://www.nmfs.noaa.gov/pr/sars/ or determine that the activity that will for public comment on any proposed from any NMFS Regional Office at the result in incidental take is not likely to determination. The determination is addresses listed below: jeopardize the continued existence of based on the best available scientific, NMFS, Northeast Region, 55 Great the affected listed species. In some commercial, or other information Republic Drive, Gloucester, MA 01930– cases, NMFS has been able to make this regarding sea turtle-fishery interactions; 2298; determination because the fishery is sea turtle distribution; sea turtle NMFS, Southeast Region, 263 13th conducted with modified gear or strandings; fishing techniques, gears Avenue South, St. Petersburg, FL 33701; modified fishing practices that NMFS used, target species, seasons and areas NMFS, Southwest Region, 501 W. has been able to evaluate. However, for fished; or qualitative data from logbooks Ocean Blvd., Suite 4200, Long Beach, some Federal fisheries and most state or fisher reports. Specifically, this CA 90802–4213; or fisheries, NMFS has not granted an determination is based on the extent to NMFS, Pacific Islands Region, exception primarily because we lack which: Protected Resources, 1601 Kapiolani information about fishery-turtle (1) The fishery operates in the same Boulevard, Suite 1100, Honolulu, HI interactions. Therefore, any incidental waters and at the same time as sea 96814–4700. take of sea turtles in those fisheries is turtles are present; Purpose of the Sea Turtle Observer unlawful as it has not been exempted (2) The fishery operates at the same Requirement from the ESA prohibition on take. time or prior to elevated sea turtle The most effective way for NMFS to strandings; or Under the ESA, 16 U.S.C. 1531 et seq., learn more about sea turtle-fishery (3) The fishery uses a gear or NMFS has the responsibility to interactions in order to minimize or technique that is known or likely to implement programs to conserve marine prevent take is to place observers aboard result in incidental take of sea turtles life listed as endangered or threatened. fishing vessels. In 2007, NMFS issued a based on documented or reported takes All sea turtles found in U.S. waters are regulation (50 CFR 222.402) to establish in the same or similar fisheries; and listed as either endangered or procedures through which each year (4) NMFS intends to monitor the threatened under the ESA. Kemp’s NMFS will identify, pursuant to fishery and anticipates that it will have ridley (Lepidochelys kempii), specified criteria and after notice and the funds to do so. leatherback (Dermochelys coriacea), and opportunity for comment, those The AA uses the most recent version hawksbill (Eretmochelys imbricata) sea fisheries in which the agency intends to of the annually published MMPA List of turtles are listed as endangered. place observers (72 FR 43176, August 3, Fisheries (LOF) as the comprehensive Loggerhead (Caretta caretta), green 2007). These regulations specify that list of commercial fisheries for (Chelonia mydas), and olive ridley NMFS may place observers on U.S. consideration. The LOF includes all (Lepidochelys olivacea) sea turtles are fishing vessels, either recreational or known state and Federal commercial listed as threatened, except for breeding commercial, operating in U.S. territorial fisheries that occur in U.S. waters. The colony populations of green turtles in waters, the U.S. exclusive economic classification scheme used for fisheries Florida and on the Pacific coast of zone (EEZ), or on the high seas, or on on the LOF would not be relevant to this Mexico and breeding colony vessels that are otherwise subject to the process. Unlike the LOF process, an populations of olive ridleys on the jurisdiction of the U.S. annual determination may also include Pacific coast of Mexico, which are listed NMFS and/or interested cooperating recreational fisheries likely to interact as endangered. Due to the inability to entities will pay the direct costs for with sea turtles on the basis of the best distinguish between populations of vessels to carry observers. These include available information. green turtles away from the nesting observer salary and insurance costs. NMFS consulted with appropriate beach, NMFS considers green turtles NMFS may also evaluate other potential state and Federal fisheries officials and endangered wherever they occur in U.S. direct costs, should they arise. Once other entities to identify which waters. While some sea turtle selected, a fishery will be eligible to be fisheries, both commercial and populations have shown signs of observed for five years without further recreational, should be considered in recovery, many populations continue to action by NMFS. This will enable NMFS the annual determination. Although the decline. to develop an appropriate sampling comments and recommendations Incidental take, or bycatch, in fishing protocol to investigate whether, how, provided to NMFS by states were based gear is one of the main sources of sea when, where, and under what upon the best available information on turtle injury and mortality nationwide. conditions incidental takes are their fisheries, NMFS received more
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recommendations for fisheries to identified in the AD and vessels in those include green, hawksbill, Kemp’s ridley, include on the 2010 AD than is feasible particular fisheries: leatherback, and loggerhead turtles. The to propose at this time based on the four (1) The requirements to obtain the waters off the U.S. East Coast represent previously noted criteria (50 CFR best available scientific information; important residential, migrating, and 222.402(a)). (2) The requirement that observers be foraging habitat for several of these The AD is not an exhaustive or assigned fairly and equitably among species. Further, the Southeastern U.S. comprehensive list of all fisheries with fisheries and among vessels in a fishery; is a major sea turtle nesting area for documented or suspected takes of sea (3) The requirement that no loggerheads and, to a lesser extent, turtles; there are additional fisheries individual person or vessel, or group of green and leatherback turtles. that NMFS remains concerned about. persons or vessels, be subject to Four species, green, Kemp’s ridley, For these additional fisheries, NMFS inappropriate, excessive observer leatherback, and loggerhead turtles, may already be addressing incidental coverage; and occur seasonally in southern New take through another mechanism (e.g., (4) The need to minimize costs and England and mid-Atlantic continental rulemaking to implement modifications avoid duplication, where practicable. shelf waters north of Cape Hatteras, to fishing gear and/or practices) or will Vessels where the facilities for North Carolina. The occurrence of these consider adding them to future annual accommodating an observer or carrying species in these waters is temperature determinations based on the four out observer functions are so inadequate dependent. In general, turtles move up previously noted criteria (50 CFR or unsafe (due to size or quality of the coast from southern wintering areas 222.402(a)). equipment, for example) that the health as water temperatures warm in the Notice of the final determination will or safety of the observer or the safe spring. The trend is reversed in the fall be published in the Federal Register operation of the vessel would be as water temperatures decrease. By and made in writing to individuals jeopardized, would not be required to December, turtles have passed Cape permitted for each fishery identified for take observers under this proposed rule. Hatteras, returning to more southern monitoring. NMFS will also notify state Nonetheless, per Magnuson-Stevens waters for the winter. Hard-shelled agencies and provide notification Fishery Conservation and Management species are typically observed as far through publication in local Act (MSA) regulations for observers (50 north as Cape Cod, Massachusetts, newspapers, radio broadcasts, and other CFR 600.746), a vessel that would whereas more cold-tolerant leatherbacks means, as appropriate. Once included in otherwise be required to carry an are observed farther north in northern the final determination, a fishery will observer, but is inadequate or unsafe for Gulf of Maine waters in the summer and remain eligible for observer coverage for purposes of carrying an observer and for fall. five years to enable the design of an allowing operation of normal observer Green turtles are found in inshore and appropriate sampling program and to functions, is prohibited from fishing nearshore waters from Texas to ensure collection of sufficient scientific without observer coverage. However, Massachusetts, the U.S. Virgin Islands, data for analysis. If NMFS determines observation techniques using alternative that more than five years are needed to and Puerto Rico. While foraging and platforms apart from the fishing vessel, developmental habitats also occur in the obtain sufficient scientific data, NMFS but still requiring the cooperation of will include the fishery in the proposed wider Caribbean, important feeding fishermen, may be employed in such areas in Florida include the Indian River AD again prior to the end of the fifth instances as appropriate. Failure to year. As part of the 2010 AD, NMFS has Lagoon, the Florida Keys, Florida Bay, comply with the requirements under Homosassa, Crystal River, Cedar Key, included, to the extent practicable, this rule may result in civil or criminal information on the fisheries or gear and St. Joseph Bay. The bays and penalties under the ESA. sounds of North Carolina also provide types to be sampled, geographic and Observer programs designed or seasonal scope of coverage, and any important foraging habitat for green carried out in accordance with 50 CFR turtles, which can occur in those areas other relevant information. After 222.404 would be required to be publication of a final AD, a 30–day in relatively high densities. consistent with existing observer-related In the Atlantic, hawksbills are most delay in effective date for implementing NOAA policies and regulations, such as observer coverage will follow, except for common in Puerto Rico and its those under the Fair Labor and those fisheries where the AA has associated islands and in the U.S. Virgin Standards Act (29 U.S.C. 201 et seq.), determined that there is good cause Islands. In the continental U.S., the the Service Contract Act (41 U.S.C. 351 pursuant to the Administrative species is recorded from all the Gulf et seq.), Observer Health and Safety Procedure Act to make the rule effective States and along the east coast as far regulations (50 CFR 600), and other without a 30–day delay. north as Massachusetts, but sightings relevant policies. north of Florida are rare. Hawksbills are Implementation of Observer Coverage Fisheries not included on the 2010 observed in Florida on the reefs off Palm in a Fishery Listed on the 2010 Annual AD may still be observed under a Beach, Broward, Miami-Dade, and Determination different authority than the ESA (e.g., Monroe Counties. Texas is the only The design of any observer program MMPA, MSA). other U.S. state where hawksbills are for fisheries identified through the AD Additional information on observer sighted with any regularity. process, including how observers would programs in commercial fisheries can be Kemp’s ridleys are distributed be allocated to individual vessels, found on the NMFS National Observer throughout waters of the Gulf of Mexico would vary among fisheries, fishing Program’s website: http:// and U.S. Atlantic coast, from Florida to sectors, gear types, and geographic www.st.nmfs.gov/st4/nop/; links to New England. The major nesting area regions and would ultimately be individual regional observer programs for Kemp’s ridleys is in Tamaulipas, determined by the individual NMFS may also be found on this website. Mexico, but some nesting also occurs Regional Office, Science Center, and/or Sea Turtle Distribution along the Texas coast. observer program. During the program The second largest nesting aggregation design, NMFS would be guided by the Atlantic Ocean and Gulf of Mexico of loggerheads in the world occurs in following standards for distributing and Sea turtle species found in waters of the southeastern U.S. Loggerheads occur placing observers among fisheries the Atlantic Ocean and Gulf of Mexico throughout the Atlantic and Gulf of
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Mexico, spending significant time in along the west coast for foraging. The November of each year, with the highest coastal areas. general distribution of olive ridleys concentration of strandings between Adult leatherbacks are capable of along the U.S. west coast is unknown at June and September; strandings are not tolerating a wide range of water this time. regularly observed in the winter and temperatures, and have been sighted Sea turtles occur throughout the early spring. along the entire continental coast of the Pacific Islands Region including the On the U.S. West Coast, strandings are United States as far north as the Gulf of State of Hawaii and the U.S. territories infrequent compared to the Atlantic and Maine and south to Puerto Rico, the of Guam, American Samoa, and the Gulf of Mexico coasts predominantly U.S. Virgin Islands, and into the Gulf of Commonwealth of the Northern Mariana due to oceanographic features (e.g., Mexico. The central east coast of Florida Islands (CNMI). Green and hawksbill currents) and species abundance and represents a small, but growing, nesting turtles are most common in nearshore distribution. Between 2003 and 2007, area for leatherbacks in the western waters while leatherbacks, loggerheads, the STSSN in California documented North Atlantic. and olive ridleys occur in offshore strandings of three species: green, pelagic waters. Stock structure and leatherback, and olive ridley turtles. U.S. Pacific Ocean population dynamics for some species Green turtles represent the highest Leatherback sea turtles are found in this region are poorly understood. number of strandings. Strandings were consistently off the U.S. west coast, Sea Turtle Strandings documented in all months except April; usually north of Point Conception, data indicate a peak in strandings California. Green turtles, loggerhead, NMFS reviewed data collected by the between July and October. and olive ridley sea turtles are rarely Sea Turtle Stranding and Salvage In Oregon and Washington, very few observed in the west coast EEZ, but Network (STSSN) between 2003 and strandings were recorded between 2003 records show that all species have 2007 to identify stranding trends and and 2007. Green, loggerhead, and olive stranded in California and the Pacific inform development of this proposed ridley turtle strandings were recorded Northwest. Leatherbacks are known to rule. Cold stunned, captive-reared, and from December to March, with no migrate to central and northern post-hatchling turtles were not included strandings documented from April California from their natal beaches in in the data reviewed. through November. Prior to 2003, the Western Pacific to feed on jellyfish. Between 2003 and 2007, the STSSN stranded leatherback turtles were During aerial surveys conducted since along the U.S. Atlantic and Gulf coasts recorded in Oregon and Washington. the early 1990s, leatherbacks were most collectively documented strandings of In the Pacific Islands region, often spotted off Point Reyes, south of six species: loggerhead, Kemp’s ridley, strandings occur throughout the year, Point Arena, in the Gulf of the green, leatherback, hawksbill, and olive primarily green turtles and secondarily Farallons, and in Monterey Bay. ridley turtles, with loggerheads hawksbills in Hawaii, Guam, American Leatherback turtles usually appear in consistently representing the highest Samoa, and CNMI. Monterey Bay and California coastal number of strandings. For the purposes waters during August and September of this review, the U.S. Atlantic and Addition of Fisheries on the 2010 and move offshore in October and Gulf of Mexico coastline is divided into Annual Determination November. Other observed areas of three regions: (1) Gulf, including all NMFS is proposing to include 19 summer leatherback concentration Gulf of Mexico waters from TX through fisheries (17 in the Atlantic Ocean and include northern California and the the FL gulf coast, (2) Southeast Atlantic, Gulf of Mexico and 2 in the Pacific waters off Washington through northern including U.S. Atlantic waters from FL Ocean) on the 2010 AD. These 19 Oregon, offshore from the Columbia east coast through NC, and (3) Northeast fisheries, described below and listed in River plume. Atlantic, including all U.S. Atlantic Table 1, represent several gear types, Green, loggerhead, and olive ridley waters from VA through ME. Of the including trawl, gillnet, trap/pot, and sea turtles are generally found in waters three regions, the Southeast Atlantic pound net/weir/seine. temperatures above 18 C, which is consistently records the highest level of As described above, the most recent warmer than the waters off most of strandings during any given month, LOF is used as the universe of California, Oregon, and Washington. each year. In each region, as well as commercial fisheries included on the Two small populations of green turtles collectively, loggerhead sea turtles AD. The fishery name, definition, and occur in the southern California Bight represent the highest number of annual number of vessels/persons specified on utilizing the warm water outflows from strandings, followed by Kemp’s ridley the AD are taken from the most recent power plants in San Diego Bay and and leatherback turtles in the Atlantic final LOF. Additionally, the fishery Alamitos Bay in Long Beach, California. and green turtles in the Gulf. descriptions below include a particular In the eastern Pacific, loggerheads have Based on the data reviewed, fishery’s current classification on the been reported as far north as Alaska, strandings have occurred in each month MMPA LOF (i.e., Category I, II, or III); and as far south as Chile. Occasional of the year, in all three regions; Category I and II fisheries are required sightings are reported from the coasts of however, distinct trends are notable to carry observers if requested by NMFS. Washington and Oregon, but most within each region. In the Gulf and As noted previously, NMFS also has records are of juveniles off the coast of Southeast Atlantic regions, strandings authority to observe fisheries in Federal California. Based upon limited observer consistently occur in every month of the waters under the MSA, under which records, loggerheads travel into the year. In the Gulf region, the highest NMFS has collected sea turtle bycatch southern California Bight during El concentration of strandings occurs from information. Nino events (or warm water conditions March to August, with a notable peak in similar to an El Nino). The majority of April and May. In the Southeast Trawl Fisheries fishery interactions with loggerheads Atlantic region, the highest Interactions with trawl fisheries are of during El Nino conditions have concentration of strandings occurs from a particular concern for sea turtles, since occurred during the summer. Olive March to November, with a notable peak forced submergence in any type of ridleys have been recorded stranded all in May and June. In the Northeast restrictive gear could lead to lack of along the U.S. west coast. Olive ridleys Atlantic region, strandings oxygen and subsequent death by are believed to use warm water currents predominately occur between May and drowning. Metabolic changes that can
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impair a sea turtle’s ability to function Atlantic Shellfish Bottom Trawl Fishery fishery and the mid-Atlantic flynet can occur within minutes of a forced The Atlantic shellfish bottom trawl fishery as defined on the LOF. The Mid-Atlantic bottom trawl fishery submergence (Lutcavage et al., 1997). fishery (estimated 972 vessels/persons) (estimated ≤1,000 vessels/persons), as Trawls that are not outfitted with encompasses the calico scallop trawl, defined on the LOF, uses bottom trawl turtle excluder devices (TEDs) may crab trawl, Georgia/South Carolina/ gear to target species including, but not result in forced submergence. Currently, Maryland whelk trawl, Gulf of Maine/ limited to, bluefish, croaker, monkfish, Mid-Atlantic sea scallop trawl, and Gulf only trawl fisheries capable of catching summer flounder (fluke), winter of Maine northern shrimp trawl (71 FR shrimp and operating south of Cape flounder, silver hake (whiting), spiny 2006, January 4, 2006). This fishery Charles, VA, and in the Gulf of Mexico dogfish, smooth dogfish, scup, and as well as trawl fisheries targeting extends from Maine through Florida. black sea bass. The fishery occurs year- summer flounder south of Cape Charles, The fishery is managed through Federal round from Cape Cod, MA, to Cape VA, are required to use TEDs. and interstate fishery management plans Hatteras, NC, in waters west of 72 30’ (FMPs). NMFS’ Strategy for Sea Turtle W. long. and north of a line extending This fishery is classified as Category Conservation and Recovery in Relation due east from the North Carolina/South III on the MMPA LOF; however, to Atlantic Ocean and Gulf of Mexico Carolina border. The gear is managed by portions of the fishery have been Fisheries (‘‘Strategy’’), a gear-based several state and Federal FMPs. observed at low levels under MSA The Mid-Atlantic flynet fishery approach to addressing sea turtle authority and by the Georgia bycatch, has identified trawl gear as a (estimated 21 vessels/persons), as Department of Natural Resources (GA defined on the LOF, is a multi-species priority given our knowledge of the DNR). level of bycatch in this gear and the fishery composed of nearshore and Since 2004, 16 sea turtle takes were offshore components that operate along availability of technology that allows reported by NMFS trained observers in sea turtles to escape the trawl net, the east coast of the mid-Atlantic United the Atlantic sea scallop trawl fishery. States. Flynets typically range from 80– minimizing injury and mortality. The Takes of sea turtles in scallop trawl gear Strategy is currently evaluating 120 ft (24–36.6 m) in headrope length, have been observed during the months with wing mesh sizes of 16–64 in (41– mitigation measures for trawl fisheries from June through October. One of the 163 cm), following a slow 3:1 taper to that overlap with sea turtles. Several 16 sea turtles captured in scallop trawl smaller mesh sizes in the body, fisheries that NMFS proposes to include gear was decomposed indicating it was extension, and codend sections of the on the 2010 AD may be considered for not killed as a result of the scallop trawl net. The nearshore fishery operates from sea turtle conservation measures under gear in which it was observed. Fourteen October to April inside of 30 fathoms the Strategy in a future rulemaking to of the non-decomposed turtles were (180 ft; 55 m) from New Jersey to North implement the prohibition of take and loggerhead sea turtles, while one was Carolina. This nearshore fishery targets to help conserve and recover sea turtles. not identified to species. Atlantic croaker, weakfish, butterfish, Several states included trawl fisheries In addition, loggerhead sea turtle harvestfish, bluefish, menhaden, striped in their responses to NMFS’ request for bycatch in the mid-Atlantic sea scallop bass, kingfish species, and other finfish information and recommendations for trawl fishery, one component of the species. Flynet fishing is no longer the 2010 AD. Massachusetts noted that Atlantic shellfish bottom trawl fishery, permitted in Federal waters south of summer flounder trawlers are known to was estimated for 2004 and 2005. The Cape Hatteras to a line extending from interact with sea turtles. New York average annual bycatch estimates of the NC/SC border in order to protect recommended considering bottom otter loggerhead sea turtles in 2004 and 2005 weakfish stocks. The offshore trawl fisheries given that this is one of in mid-Atlantic sea scallop trawl gear component operates from November to the top gear types in terms of pounds ranged from 81 to 191 turtles, April outside of 30 fathoms (180 ft; 55 landed in Long Island Sound, Peconic depending on the estimation m) from the Hudson Canyon off New Bay, and along the South Shore. New methodology used (Murray 2007). GA York, south to Hatteras Canyon off Jersey suggested focusing observer DNR conducted a limited observer North Carolina. These deeper water program in the trawl fishery targeting coverage in areas where trawl gear fisheries target bluefish, Atlantic whelk in the late 1990s; 7 turtles (3 overlaps with sea turtle observations. mackerel, Loligo squid, black sea bass, Kemp’s ridleys, 2 greens, and 2 Maryland reported that interactions and scup (72 FR 7382, February 15, loggerheads) were taken in 28 observed 2007). Illex squid are also targeted between bottom otter trawl gear as well tows. NMFS is particularly interested in offshore (70–200 fathoms [420–1,200 ft; as beam trawl gear and sea turtles are observing this fishery in waters off of 128–366 m]) during summer months possible in the Atlantic Ocean (0–3 Massachusetts and south as sea turtles from May to September. miles (0–4.8 km)) and there have been more commonly occur in this area. The Mid-Atlantic bottom trawl fishery reports of sea turtles captured in trawl NMFS proposes to include this and the Mid-Atlantic flynet fishery are gear. North Carolina ranked trawls fishery on the 2010 AD based on currently classified as Category II on the operating in ocean waters as their top documented interactions with sea MMPA LOF, which authorizes NMFS to priority based on NMFS’ four criteria. turtles in this and other bottom trawl observe these fisheries for marine South Carolina noted that both trynets fisheries and the need to obtain more mammal interactions, and to collect and whelk trawls are of concern. information on the interactions in this information on sea turtles should a take Georgia, Florida, and Alabama all noted fishery. occur on an observed trip. Between trawl fisheries as well. Mississippi 2003 and 2007, observer coverage as highlighted skimmer trawls in their Mid-Atlantic Bottom Trawl Fishery reported in the Marine Mammal Stock response to NMFS’ request for Bottom otter trawl nets include a Assessment Report (SAR) ranged from a recommendations. Therefore, based on variety of net types, including flynets, low of 1% to a high of 18.61% the information provided by states and which are high profile trawls. The depending on target species; see the best available scientific information, ‘‘Mid-Atlantic bottom trawl fishery’’ as Appendix III of the draft 2009 SAR for NMFS proposes to include the following described in this proposed AD includes additional details (NMFS, 2009). It trawl fisheries on the 2010 AD. both the mid-Atlantic bottom trawl should be noted that the mid-Atlantic
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bottom trawl fishery is defined slightly NMFS proposes to include this needed to make well informed differently in the SARs (which use 70° fishery on the 2010 AD to more management decision on what actions W as a boundary) than it is defined here adequately observe this gear type in may be necessary to manage this fishery and in the LOF. NMFS will consider areas and during times where it overlaps to minimize and prevent sea turtle takes changing this definition in a future LOF. with sea turtle distribution. and further sea turtle conservation and Since 2003, NMFS has documented recovery. 50 sea turtle takes (excluding severely Southeastern U.S. Atlantic, Gulf of The Southeastern U.S. Atlantic, Gulf decomposed animals) in bottom otter Mexico Shrimp Trawl Fishery of Mexico shrimp trawl fishery is trawl gear in the mid-Atlantic. These The Southeastern U.S. Atlantic, Gulf classified as Category III on the MMPA takes occurred primarily between of Mexico shrimp trawl fishery LOF, but mandatory observer coverage October and February, but takes were (estimated ≤18,000 vessels/persons) under MSA authority began in 2007. also reported May through September. targets shrimp using various types of The fishery is currently observed at In 2007, the observer program created trawls; NMFS would focus on the approximately 1% of total fishery effort. new codes to document the different net component of the fishery that uses NMFS is proposing to include the types used, including flynets. Seven of skimmer trawls for the 2010 AD. Southeastern U.S. Atlantic, Gulf of the takes were recorded on trips where Skimmer trawls are used primarily in Mexico shrimp trawl fishery, to focus flynets were indicated as the specific inshore/inland shallow waters (typically observer coverage in the component of net type used. Loggerhead turtles were less than 20 ft (6.1 m)) to target shrimp. the fishery that uses skimmer trawls, on the predominant species observed The skimmer trawl has a rigid ‘‘L’’- the 2010 AD. taken, but leatherback turtles were also shaped or triangular metal frame with Gillnet Fisheries documented. An estimate of the average the inboard portion of the frame annual bycatch of loggerhead sea turtles attached to the vessel and the outboard Sea turtles are vulnerable to in mid-Atlantic bottom otter trawl gear portion attached to a skid that runs entanglement and drowning in gillnets, during 1996–2004 was completed in along the seabed. especially when the gear is left 2006. The analysis defined the mid- Skimmer trawl use increased in untended. The main risk to sea turtles Atlantic as the region from the shoreline response to TED requirements for from capture in gillnet is forced below 41° 30’ N./66° W. to the southern shrimp bottom otter trawls. Skimmer submergence. Entanglement in gillnets extent of the NEFSC observer data trawls currently have no TED can also result in severe abrasions on collection, around 35° 00’ N. lat. and 75° requirement but are subject to tow time entangled turtles. Large mesh gillnets 30’ W. long. Estimated average annual limits of 55 minutes from April 1 to (e.g., 10–12 in. (25.4–30.5 cm) stretched bycatch of loggerhead turtles in mid- October 31 and 75 minutes from mesh) have been documented as Atlantic bottom otter trawl gear during November 1 to March 31. Skimmer effective at capturing sea turtles. 1996–2004 was 616 animals (Murray, trawls are used in North Carolina, Additionally, sea turtles have been 2008). Florida (Gulf Coast), Mississippi, and documented as entangled in smaller NMFS proposes to include this Louisiana. There are documented takes mesh gillnets. fishery on the 2010 AD to more of sea turtles in skimmer trawls in North Several states (i.e., CA, NY, NJ, DE, adequately observe this gear type where Carolina, and anecdotal reports MD, VA, NC, AL) recommended and when it overlaps with sea turtle elsewhere. In North Carolina, there were including gillnet fisheries on the 2010 distribution. 150–200+ active vessels per year from AD. California recommended two small 2000–2002 and in Louisiana, skimmer mesh gillnet fisheries. New York Mid-Atlantic Mid-water Trawl trawls accounted for 37% of the shrimp recommended considering sink gillnets (including pair trawl) Fishery catch and 63% of the total shrimp and runaround gillnets, particularly The Mid-Atlantic mid-water trawl trawling effort from 1999–2004. those operating off the South Shore and fishery (estimated 620 vessels/persons) Louisiana skimmer trawl effort averaged Peconic Bay. During the time sea turtles primarily targets Atlantic mackerel, about 60,750 trips per year over that are present in New York waters, gillnets chub mackerel, and miscellaneous other period, ranging from about 81,700 trips are one of the top gear types in terms of pelagic species. This fishery consists of in year 2000 to 49,000 trips in year pounds landed along the South Shore. both single and pair trawls, which are 2004. No effort information is available New Jersey recommended observing designed, capable, or used to fish for for Mississippi and Florida. gillnet fisheries operating in areas that pelagic species with no portion of the Skimmer trawl effort overlaps with overlap with sea turtle sightings. gear designed to be operated in contact sea turtle distribution, and as noted Delaware identified gillnet gear as a with the bottom. The fishery for Atlantic above, takes have been reported. concern based on the potential for mackerel occurs primarily from Although subject to tow times, the interactions. Maryland noted that southern New England through the mid- magnitude and impact of turtle takes in potential for sea turtle takes exists in Atlantic from January to March and in this fishery are not understood, and no gillnet fisheries operating within coastal the Gulf of Maine during the summer observer program currently exists for bays and tidal tributaries, but no takes and fall (May to December). this portion of the shrimp fishery. Given have been documented. Virginia noted The Mid-Atlantic mid-water trawl the extent this gear is used, NMFS that there are state regulations for fishery is currently classified as thinks it is important to better gillnets in an effort to conserve and Category II on the MMPA LOF, which understand these interactions. protect sea turtles in their waters. North authorizes NMFS to observe this fishery NMFS is considering including Carolina ranked large mesh commercial for marine mammal interactions, and to skimmer trawls under the Atlantic gillnets operating in estuarine waters as collect information on sea turtles should Ocean and Gulf of Mexico Sea Turtle a top concern. Alabama noted gillnets in a take occur on an observed trip. During Strategy, which may result in a their response to NMFS’ request for 2003–2007, estimated observer coverage regulation to require TEDs or other recommendations. In addition, NMFS’ year-round in this fishery was 3.5%, protections for sea turtles for all trawl Strategy for Sea Turtle Conservation and 12.16%, 8.4%, 8.9%, and 3.85%, gears as appropriate. Observer coverage Recovery in Relation to Atlantic Ocean respectively (NMFS 2009); no sea turtle to understand the scope and impact of and Gulf of Mexico Fisheries has takes were observed. turtle takes by this gear will also be identified gillnet gear as a high priority.
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Therefore, based on the information gillnets are up to 6,000 ft (1,829 m) long Long Island Inshore Gillnet Fishery provided by states and the best available and are set at the surface. The mesh size The Long Island Sound inshore gillnet scientific information, NMFS proposes depends on target species and is fishery (estimated 20 vessels/persons) to include the following gillnet fisheries typically 6.0–6.5 in (15–16.5 cm). When includes all gillnet fisheries setting nets on the 2010 AD. targeting yellowtail and barracuda, the ≥ west of a line from the north fork of the CA Halibut, White Seabass and Other mesh size must be 3.5 in (9 cm); when eastern end of Long Island, NY (Orient targeting white seabass, the mesh size Species Set Gillnet Fishery (>3.5 in ≥ Point to Plum Island to Fishers Island) mesh) must be 6 in (15.2 cm). From June 16 to Watch Hill, RI (59 FR 43703, August to March 14 not more than 20 percent, The CA halibut, white seabass, and 25, 1994). Target species include, but by number, of a load of fish may be are not limited to bluefish, striped bass, other species set gillnet fishery white seabass with a total length of 28 (estimated 58 vessels/persons) targets weakfish, and summer flounder. in (71 cm). A maximum of ten white This fishery is classified as Category halibut, white seabass, and other species seabass per load may be taken, if taken from the U.S.-Mexico border north to III on the MMPA LOF and NMFS has in gillnet or trammel nets with meshes not previously required vessels Monterey Bay using 200 fathom (1,200 from 3.5–6.0 in (9–15 cm) in length. The ft; 366 m) gillnet with a stretch mesh operating in this fishery to carry an fishery operates year-round, primarily observer. NMFS has previously size of 8.5 in (31.6 cm). Net soak south of Point Conception with some duration is typically 8–10, 19–24, or 44– observed this fishery at extremely low effort around San Clemente Island and levels; no sea turtle takes were observed. 49 hours at a depth ranging from 15–50 San Nicolas Island. This fishery is a fathoms (90–300 ft; 27–91 m) with most NMFS proposes to include this fishery limited entry fishery with various gear in the 2010 AD because sea turtles are sets from 15–35 fathoms (90–210 ft; 27– restrictions and area closures managed 64 m). No more than 1500 fathoms known to occur in the same areas where by the California Department of Fish the fishery operates and takes have been (9,000 ft; 2,743 m) of gill or trammel net and Game (CDFG). may be fished in combination for CA documented in similar gear types. This fishery is classified as Category halibut and angel shark. Fishing occurs II on the MMPA LOF, which authorizes Mid-Atlantic Gillnet Fishery year-round, with effort generally NMFS to observe this fishery for marine increasing during summer months and The Mid-Atlantic gillnet fishery mammal interactions, and to collect declining during last the 3 months of (estimated 7,596 vessels/persons) targets information on sea turtles should a take the year. The central CA portion of the monkfish, spiny dogfish, smooth fishery from Point Arguello to Point occur on an observed trip. This fishery dogfish, bluefish, weakfish, menhaden, Reyes has been closed since September, was observed in 2003 and 2004, with spot, croaker, striped bass, large and 2002, following a ban on gillnets 10.4% and 11.0% coverage, small coastal sharks, Spanish mackerel, inshore of 60 fathoms (360 ft; 110 m). respectively. No sea turtle takes were king mackerel, American shad, black Set gill nets have been prohibited in observed during 2003 or 2004. NMFS drum, skate spp., yellow perch, white state waters south of Point Arguello and proposes to include this fishery on the perch, herring, scup, kingfish, spotted within 70 fathoms (420 ft; 128 m) or one 2010 AD because it operates in the same seatrout, and butterfish. The fishery mile (1.6 km), whichever is less, around waters that turtles are known to occur uses drift and sink gillnets, including the Channel Islands since 1990. The and this gear type is known to result in nets set in a sink, stab, set, strike, or California Department of Fish and Game the incidental take of sea turtles based drift fashion, with some unanchored (CDFG) manages the fishery as a limited on documented takes in similar drift or sink nets used to target specific entry fishery with gear restrictions and fisheries. species. The dominant material is area closures. Chesapeake Bay Inshore Gillnet Fishery monofilament twine with stretched This fishery is classified as Category mesh sizes from 2.5–12 in (6.4–30.5 II on the MMPA LOF, which authorizes The Chesapeake Bay inshore gillnet cm), and string lengths from 150–8,400 NMFS to observe this fishery in state fishery (estimated 45 vessels/persons) ft. (46–2,560 m). This fishery operates waters for marine mammal interactions, targets menhaden and croaker using year-round west of a line drawn at 72° and to collect information on sea turtles gillnet gear with mesh sizes ranging 30’ W. long. south to 36° 33.03’ N. lat. should a take occur on an observed trip. from 2.75–5 in (7–12.7 cm), depending and east to the eastern edge of the EEZ This fishery was observed at about on the target species. The fishery and north of the North Carolina/South 17.8% in 2007 and 5% in 2008. No sea operates between the Chesapeake Bay/ Carolina border, not including waters turtle takes were observed during 2007 Bridge Tunnel and the mainland. The where inshore gillnet fisheries (i.e., or 2008. NMFS proposes to include this fishery is managed under the Interstate Chesapeake Bay, North Carolina, Long fishery on the 2010 AD because it FMPs for Atlantic Menhaden and Island Sound inshore gillnet fisheries) operates in the same waters that turtles Atlantic Croaker. operate in bays, estuaries, and rivers. are known to occur and this gear type This fishery is classified as Category This fishery includes any residual large is known to result in the incidental take II on the MMPA LOF, which authorizes pelagic driftnet effort in the mid- of sea turtles based on documented NMFS to observe this fishery in state Atlantic and any shark and dogfish takes in similar fisheries. waters for marine mammal interactions, gillnet effort in the mid-Atlantic zone and to collect information on sea turtles described. The fishing effort is CA Yellowtail, Barracuda, and White should a take occur on an observed trip. prosecuted right off the beach (6 ft [1.8 Seabass Drift Gillnet Fishery (mesh size NMFS has previously observed this m]) or in nearshore coastal waters to >3.5 in. and <14 in.) fishery at extremely low levels. NMFS offshore waters (250 ft [76 m]). The CA yellowtail, barracuda, and proposes to include this fishery on the Gear in this fishery is managed by white seabass drift gillnet fishery (24 2010 AD because sea turtles are known several Federal FMPs and Interstate vessels/persons) targets primarily to occur in the same areas where the FMPs managed by the Atlantic States yellowtail and white seabass, and fishery operates, takes have been Marine Fisheries Commission (ASMFC). secondarily barracuda, with target previously documented in similar gear, Fisheries are primarily managed by species typically determined by market and the fishery operates during a period TACs; individual trip limits (quotas); demand on a short-term basis. Drift of high sea turtle strandings. effort caps (limited number of days at
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sea per vessel); time and area closures; (9–228.6 m), with some nets deeper than spatially with areas utilized by sea and gear restrictions and modifications. 800 ft (244 m). turtles, often at relatively high densities. This fishery is classified as Category This fishery is managed by the Additionally, the likelihood of I on the MMPA LOF, which authorizes Northeast Multispecies (Groundfish) significant injury or mortality to sea NMFS to observe this fishery in state FMP. This fishery is also managed by turtles when taken by this gear is high. and federal waters for marine mammal the Atlantic Large Whale Take NMFS recently conducted a limited interactions, and to collect information Reduction Plan (ALWTRP) and the observer program in the southern on sea turtles should a take occur on an Harbor Porpoise Take Reduction Plan flounder gillnet fishery in Core Sound, observed trip. During 2003–2007, (HPTRP) to reduce the risk of which was previously unobserved. estimated observer coverage year-round entanglement of right, humpback, and Several sea turtles (green, Kemp’s in this fishery was 1%, 2%, 3%, 4%, fin whales, and harbor porpoises, ridley, and loggerhead) were observed and 6%, respectively (NMFS, 2009). respectively. The fishery is primarily taken in the fishery. Take levels were Since 2003, 12 takes (excluding severely managed through TAC limits; highly variable, but generally high, with decomposed animals) of loggerhead, individual trip limits (quotas); effort many observed trips taking no sea leatherback, green, and Kemp’s ridley caps (limited number of days at sea per turtles, and other trips having as many turtles were documented by observers vessel); time and area closures; and gear as five takes. A more extensive, longer- between May and December. From restrictions. term observer program is needed to This fishery is classified as Category 1995–2006, the average annual bycatch adequately assess the extent and impact I on the MMPA LOF, which authorizes estimate of loggerheads in U.S. mid- of the all components of the inshore NMFS to observe this fishery in state Atlantic sink gillnet gear was 350 turtles North Carolina gillnet fishery on sea and Federal waters for marine mammal (Murray 2009). The mid-Atlantic was turtles. Therefore, NMFS is proposing to interactions and to collect information defined in this analysis as west of 70° include this fishery on the 2010 AD. on sea turtles should a take occur on an W. long. from the shoreline of Cape Cod observed trip. During 2003–2007, Southeast Atlantic Gillnet Fishery southward to the southern limit of the estimated observer coverage year-round The Southeast Atlantic gillnet fishery observer data collection program ° in this fishery was 3%, 6%, 7%, 4%, (779 estimated vessels/persons) targets (approximately 33 N. lat.), extending 7%, respectively (NMFS, 2009). Five sea finfish including, but not limited to, westward to the coastline (Murray, turtle takes were observed during this king mackerel, Spanish mackerel, 2009). NMFS proposes to include this time. NMFS proposes to include this whiting, bluefish, pompano, spot, fishery on the 2010 AD to focus observer fishery on the 2010 AD to focus observer croaker, little tunny, bonita, jack coverage during times and in areas coverage during times and in areas crevalle, cobia, and striped mullet. This where sea turtles are known to occur. where sea turtles are known to occur, fishery does not include gillnet effort Northeast Sink Gillnet Fishery particularly in waters off Massachusetts targeting sharks as part of the and waters south of this area. Southeastern U.S. Atlantic shark gillnet The Northeast sink gillnet fishery fishery. This fishery uses gillnets set in ≤ North Carolina Inshore Gillnet Fishery (estimated 6,455 vessels/persons) sink, stab, set, or strike fashion. The targets Atlantic cod, haddock, pollock, The NC inshore gillnet fishery (94 fishery operates in waters south of a line yellowtail flounder, winter flounder, vessels/persons) targets species extending due east from the North witch flounder, American plaice, including, but not limited to, southern Carolina-South Carolina border and windowpane flounder, spiny dogfish, flounder, weakfish, bluefish, Atlantic south and east of the fishery monkfish, silver hake, red hake, white croaker, striped mullet, spotted seatrout, management council demarcation line hake, ocean pout, skate spp, mackerel, Spanish mackerel, striped bass, spot, between the Atlantic Ocean and the redfish, and shad. This fishery uses sink red drum, black drum, and shad. This Gulf of Mexico. The majority of fishing gillnet gear, which is anchored gillnet fishery includes any fishing effort using effort occurs in Federal waters since (bottom-tending net) gear fished in the any type of gillnet gear, including set South Carolina, Georgia, and Florida lower one-third of the water column. (float and sink), drift, and runaround prohibit the use of gillnets, with limited The dominant material is monofilament gillnet for any target species inshore of exceptions, in state waters. twine with stretched mesh sizes from 6– the COLREGS lines in North Carolina. Fishing for king mackerel, Spanish 12 in (15–30.5 cm) and string lengths This fishery is managed under state and mackerel, cobia, cero, and little tunny in from 600–10,500 ft (183–3,200 m), ASMFC interstate FMPs, applying net Federal waters is managed under the depending on the target species. Large and mesh size regulations, and seasonal Coastal Migratory Pelagic Resources mesh (10–14 in [25–35.6 cm]) sink area closures in the Pamlico Sound FMP. None of the other target species gillnets, either tied down or set upright Gillnet Restricted Area (PSGNRA). are Federally-managed under the MSA. without floats using a polyfoam core Gillnet fisheries operating in inshore In state waters, state and ASMFC floatline, are used when targeting and inland waters of North Carolina are Interstate FMPs apply. monkfish. The fishery operates from the currently not observed except in a This fishery is classified as Category U.S.-Canada border to Long Island, NY, limited area. An ESA section 10(a)(1)(B) II on the MMPA LOF, which authorizes at 72° 30’ W. long. south to 36° 33.03’ permit requires monitoring the Pamlico NMFS to observe this fishery in state N. lat. (corresponding with the Virginia/ Sound summer flounder gillnet fishery. and federal waters for marine mammal North Carolina border) and east to the However, extensive gillnet activity interactions, and to collect information eastern edge of the EEZ, including the occurs throughout the inshore and on sea turtles should a take occur on an Gulf of Maine, Georges Bank, and inland waters of North Carolina (e.g., observed trip. NMFS has previously Southern New England, and excluding Core Sound/Cape Fear area, Roanoke observed this fishery at moderate levels, Long Island Sound or other waters and Albemarle Sounds); effort in some primarily focused on target catch and where gillnet fisheries are classified as areas has never been observed, but other bycatch species other than sea turtles. Category III on the MMPA LOF. Fishing areas have had limited coverage, which NMFS proposes to include this fishery effort occurs year-round, peaking from was authorized under the MMPA (this on the 2010 to focus observer coverage May to July primarily on continental fishery is listed as Category II on the during times and in areas where sea shelf regions in depths from 30–750 ft MMPA LOF). Gillnet activity overlaps turtles are known to occur.
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Trap/Pot Fisheries and east of the fishery management levels; no sea turtle takes have been Turtles are known to become demarcation line between the Atlantic documented by fishery observers. entangled in the end lines (also called Ocean and the Gulf of Mexico (50 CFR However, the NMFS STDN has vertical lines) of trap/pot gear and there 600.105), including state waters. The documented 9 leatherback have been anecdotal reports that sea fishery is managed under state FMPs. entanglements in trap/pot gear targeting This fishery is classified as Category turtles may interact with the trap/pot sea bass in Massachusetts during the II on the MMPA LOF, which authorizes itself. Turtles entangled in trap/pot gear month of August from 2003 to 2008 NMFS to observe this fishery for marine may drown or suffer injuries (and (STDN, unpublished data). From 2003– mammal interactions, and to collect potential subsequent mortality) due to 2008, the STDN documented 1 green, 4 information on sea turtles should a take constriction by the rope or line. Takes loggerhead, and 8 leatherback turtle occur on an observed trip. NMFS has of both leatherback and hard-shelled sea takes in trap/pot gear targeting whelk in not observed this fishery, but has MA, VA, and NJ during May, June, July, turtles have been documented in this documented 3 sea turtle takes in blue gear type. NMFS Northeast Region August, and October. crab trap/pot gear in Virginia during the NMFS is proposing to include this established the Northeast Atlantic Sea months of May and June. One of the Turtle Disentanglement Network fishery in the 2010 AD to target observer events involved a leatherback and two coverage more specifically to obtain (STDN) in 2002 to respond to involved loggerheads (STDN, entanglements in vertical lines information on sea turtle interactions unpublished data). NMFS proposes to and how sea turtles may be interacting associated with trap/pot gear. include this fishery on the 2010 AD to Several states included trap/pot with trap/pot gear, particularly in target observer coverage more waters off of Massachusetts and waters fisheries in their responses to NMFS’ specifically to obtain information on sea request for information and south of this area, as sea turtles more turtle bycatch and how sea turtles may commonly occur in these areas. recommendations for the 2010 AD. be interacting with trap/pot gear. Massachusetts listed pots (lobster, fish, Northeast/Mid-Atlantic American whelk) as a gear type known to interact Atlantic Mixed Species Trap/Pot Fishery Lobster Trap/Pot Fishery with sea turtles. New York The Atlantic mixed species trap/pot recommended that fish, lobster, and fishery (unknown number of vessels/ The Northeast/Mid-Atlantic American crab pots be considered. Maryland persons) targets species including, but lobster trap/pot fishery (estimated ranked the commercial crab pot fishery not limited to, hagfish, shrimp, conch/ 13,000 vessels/persons) targets that operates April through December as whelk, red crab, Jonah crab, rock crab, American lobster primarily with traps, having a high possibility for interacting black sea bass, scup, tautog, cod, while 2–3 percent of the target species with sea turtles and a greater possibility haddock, pollock, redfish (ocean perch), is taken by mobile gear (trawls and for injury compared to other gear types white hake, spot, skate, catfish, and dredges). The fishery operates in in Maryland state waters. Maryland also stone crab. This fishery as defined on inshore and offshore waters from Maine ranked several other commercial pot the MMPA LOF also includes American to New Jersey and may extend as far fisheries (e.g., conch and fish) with a eel as a target species; however, there is south as Cape Hatteras, NC. lower potential to interact with sea also a Category III American eel trap/pot Approximately 80 percent of American turtles. Maryland noted reports of sea fishery listed on the LOF. Therefore, lobster is harvested from state waters; turtles getting their heads caught in the NMFS does not consider American eel therefore, the ASMFC has the primary gear while eating bait out of the trap/ to be a target species in the Atlantic regulatory role. The fishery is managed pot. Delaware included conch and blue mixed species trap/pot fishery and will in state waters under the ASMFC crab trap/pot fisheries as having correct this oversight in a future LOF. Interstate FMP and in Federal waters potential interactions with sea turtles The fishery includes all trap/pot under the Atlantic Coastal Fisheries where effort overlaps with sea turtle operations from the Maine-Canada Cooperative Management Act. distribution. Both South Carolina and border south through the waters east of This fishery is classified as Category Florida included trap/pot fisheries in the fishery management demarcation I on the MMPA LOF, which authorizes their recommendations and noted the line between the Atlantic Ocean and the NMFS to observe this fishery in state potential for using an alternative Gulf of Mexico (50 CFR 600.105), but and Federal waters for marine mammal platform program to observe this gear does not include the following trap/pot interactions, and to collect information type. fisheries (as defined on the MMPA on sea turtles should a take occur on an Therefore, NMFS proposes to include LOF): Northeast/Mid-Atlantic American observed trip. NMFS has previously the following four trap/pot fisheries, lobster trap/pot; Atlantic blue crab trap/ observed this fishery at extremely low focusing on those fisheries or pot; Florida spiny lobster trap/pot; levels; no sea turtle takes have been components of fisheries operating south Southeastern U.S. Atlantic, Gulf of observed. However, NMFS STDN has of Massachusetts, as sea turtles more Mexico stone crab trap/pot; U.S. Mid- documented 27 leatherback turtle commonly occur in this area, on the Atlantic eel trap/pot fisheries; and the entanglements in this fishery operating 2010 AD. Southeastern U.S. Atlantic, Gulf of in ME, MA, and RI. These Mexico golden crab fishery (68 FR 1421, entanglements have occurred between Atlantic Blue Crab Trap/Pot Fishery January 10, 2003). The fishery is June and October (STDN, unpublished The Atlantic blue crab trap/pot managed under various Interstate and data). fishery (estimated ≤16,000 vessels/ Federal FMPs. NMFS is proposing to include this persons) targets blue crab using pots This fishery is classified as Category fishery in the 2010 AD to target observer baited with fish or poultry typically set II on the MMPA LOF, which authorizes coverage more specifically to obtain in rows in shallow water. The pot NMFS to observe this fishery in state information on sea turtle bycatch and position is marked by either a floating and Federal waters for marine mammal how sea turtles may be interacting with or sinking buoy line attached to a interactions, and to collect information trap/pot gear, particularly in waters off surface buoy. The fishery occurs year- on sea turtles should a take occur on an of Massachusetts and waters south of round from the south shore of Long observed trip. NMFS has previously this area, as sea turtles more commonly Island at 72 30’ W. long. in the Atlantic observed this fishery at extremely low occur in these areas.
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Pound Net/Weir/Seine Fisheries historical data from Virginia, Pound net gear includes a leader posted Pound net, weir, and seine fisheries approximately 100 haul seine trips perpendicular to the shoreline and may use mesh similar to that used in occur. extending outward to the ‘‘heart,’’ The fishery is managed under the gillnets, but the gear is prosecuted which funnels the fish into the pound, Interstate FMPs for Bluefish and for differently from traditional gillnets. For where the catch accumulates. This Atlantic Striped Bass of the Atlantic example, pound net leaders have a mesh fishery includes all pound net effort in Coast from Maine through North component similar to a gillnet; sea Virginia State waters, including waters Carolina, and is subject to Bottlenose turtles have been documented entangled inside the Chesapeake Bay. The fishery Dolphin Take Reduction Plan in pound net leaders. Pound net leaders is managed under Interstate FMPs for implementing regulations. Atlantic Croaker and Spot. in the Virginia portion of the This fishery is classified as Category Chesapeake Bay are subject to The Virginia pound net fishery is II on the MMPA LOF, which authorizes currently classified as Category II on the requirements designed to reduce sea NMFS to observe this fishery for marine turtle bycatch. Purse seines and weirs MMPA LOF, which authorizes NMFS to mammal interactions, and to collect observe this fishery for marine mammal also have the potential to entangle and information on sea turtles should a take drown sea turtles. interactions, and to collect information occur on an observed trip. NMFS has on sea turtles should a take occur on an Several states included pound net/ previously observed this fishery at low weir/seine fisheries in their responses to observed trip. Loggerhead, Kemp’s levels; no sea turtle takes have been ridley, leatherback, and green turtles NMFS’ request for information and observed. NMFS proposes to include recommendations for the 2010 AD. have been observed taken in this this fishery on the 2010 AD based on fishery. Between 2002 and 2004, Massachusetts listed pound nets/weirs suspected interactions with sea turtles as a gear type known to interact with sea approximately 2,650 surveys of leaders given the nature of the gear and fishing were completed in the Virginia pound turtles. Maryland noted that sea turtles methodology in addition to effort have been documented alive and net fishery; 27 takes of sea turtles were overlapping with sea turtle distribution. recorded during the survey. uninjured in the pounds, but none have In the Chesapeake Bay, the fishery NMFS currently requires the use of a been documented in pound net leaders. operates at the same time as historically modified pound net leader in certain Virginia recognized both historical elevated sea turtle strandings. observations of interactions in this areas of the VA Chesapeake Bay to fishery as well as current regulations in Mid-Atlantic Menhaden Purse Seine reduce entanglements of sea turtles in the fishery (69 FR 24997, May 5, 2004; Fishery this gear type (71 FR 36024, June 23, 71 FR 36024, June 23, 2006). North The Mid-Atlantic menhaden purse 2006). This fishery operates at the same Carolina noted pound nets operating in seine fishery (22 estimated vessels/ time as historically elevated sea turtle estuarine waters in their persons) targets menhaden and thread strandings. NMFS proposes to include recommendations. herring using purse seine gear. Most sets this fishery on the 2010 AD to assess Therefore, based on the information occur within 3 mi (4.8 km) of shore with interactions between pound net gear provided by states and the best available the majority of the effort occurring off and sea turtles and to evaluate the scientific information, NMFS proposes North Carolina from November to effectiveness of the modified gear. to include the following four pound net/ January, and moving northward during Because some vessels in this fishery weir/seine fisheries on the 2010 AD. warmer months to southern New may be too small to carry observers, NMFS would consider observing the Mid-Atlantic Haul/Beach Seine Fishery England. The fishery is managed under the Interstate FMP for Atlantic fishery using both traditional methods The Mid-Atlantic haul/beach seine Menhaden. In the Chesapeake Bay, this as well as an alternative platform. fishery (estimated ≤221 vessels/persons) fishery operates to a limited extent U.S. Mid-Atlantic Mixed Species Stop targets striped bass, mullet, spot, during a period of high sea turtle Seine/Weir/Pound Net (except the NC weakfish, sea trout, bluefish, kingfish, strandings (May and June). roe mullet stop net) Fishery and harvest fish using seines with one This fishery is classified as Category end secured (e.g., swipe nets and long II on the MMPA LOF, which authorizes The Mid-Atlantic mixed species stop seines) and seines secured at both ends NMFS to observe this fishery for marine seine/weir/pound net fishery (estimated or those anchored to the beach and mammal interactions, and to collect 751 vessels/persons) targets several hauled up on the beach. The beach information on sea turtles should a take species, including, but not limited to, seine system also uses a bunt and a occur on an observed trip. NMFS weakfish, striped bass, shark, catfish, wash net that are attached to the beach recently began observing the fishery at menhaden, flounder, gizzard shad, and and extend into the surf. The beach low levels. NMFS proposes to include white perch. The fishery uses fixed or seines soak for less than 2 hours. The this fishery on the 2010 AD to focus staked net gear (pound net, weir, staked fishery occurs in waters west of 72° 30’ observer coverage in times and areas of trap) from Nantucket Sound to W. long. and north of a line extending sea turtle distribution and learn more Chesapeake Bay (60 FR 31681, June 16, due east from the North Carolina-South about the interactions between this 1995); the Virginia pound net and the Carolina border. Fishing on the Outer fishery and sea turtles. NC roe mullet stop net fisheries are not Banks, NC, occurs primarily in the included as part of this fishery. spring (April to June) and fall (October Virginia Pound Net Fishery This fishery is classified as Category to December). In the Chesapeake Bay, The Virginia pound net fishery III on the MMPA LOF and has never this gear has been historically fished in (estimated 41 vessels/persons) targets been observed. However, sea turtle takes the southwest portion of the Bay with species including, but not limited to, have been documented in pound net some effort in the northwest portion. croaker, menhaden, mackerel, weakfish, gear in NY, MD, VA, and NC by NMFS, Effort begins to increase in early May, and spot, using stationary gear in STSSN, and other researchers. NMFS peaks in early/mid-June, and continues nearshore Virginia waters, primarily in proposes to include this fishery on the into July. During this time, based on the Chesapeake Bay and its tributaries. 2010 to better understand the nature
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and extent of these interactions in the Table 1 – State and Federal Commercial mid-Atlantic. Fisheries included on the 2010 Annual Determination
Fishery Years Eligible to Carry Observers
Trawl Fisheries Atlantic shellfish bottom trawl 2010–2014 Mid-Atlantic bottom trawl 2010–2014 Mid-Atlantic mid-water trawl (including pair trawl) 2010–2014 Southeastern U.S. Atlantic, Gulf of Mexico shrimp trawl 2010–2014 Gillnet Fisheries CA halibut, white seabass and other species set gillnet (>3.5 in mesh) 2010–2014 CA yellowtail, barracuda, and white seabass drift gillnet (mesh size >3.5 in. and <14 in.) 2010–2014 Chesapeake Bay inshore gillnet 2010–2014 Long Island inshore gillnet 2010–2014 Mid-Atlantic gillnet 2010–2014 North Carolina inshore gillnet 2010–2014 Northeast sink gillnet 2010–2014 Southeast Atlantic gillnet 2010–2014 Trap/pot Fisheries Atlantic blue crab trap/pot 2010–2014 Atlantic mixed species trap/pot 2010–2014 Northeast/mid-Atlantic American lobster trap/pot 2010–2014 Pound Net/Weir/Seine Fisheries Mid-Atlantic haul/beach seine 2010–2014 Mid-Atlantic menhaden purse seine 2010–2014 U.S. mid-Atlantic mixed species stop seine/weir/pound net (except the NC roe mullet stop net) 2010–2014 Virginia pound net 2010–2014
Classification vessels in a fishery at any given time burden of the collection of information, The Chief Counsel for Regulation of and each vessel within an observed including through the use of automated fishery has an equal probability of being the Department of Commerce certified collection techniques or other forms of requested to accommodate an observer. to the Chief Counsel for Advocacy of the information technology. Send comments Therefore, the potential indirect costs to Small Business Administration that this on these or any other aspects of the individual fishers are expected to be rule would not have a significant collection of information to (enter office minimal because observer coverage ADDRESSES economic impact on a substantial name) at the above, and e- would only be required for a small _ number of small entities. The factual mail to David [email protected], or percentage of an individual’s total basis leading to the certification is set fax to (202) 395–7285. annual fishing time. In addition, 50 CFR forth below. Notwithstanding any other provision 222.404(b) states that an observer will NMFS has estimated that of the law, no person is required to not be placed on a vessel if the facilities respond to, nor shall any person be approximately 65,940 vessels for quartering an observer or performing participating in 19 fisheries listed in subject to a penalty for failure to comply observer functions are inadequate or with, a collection of information subject Table 1 would be eligible to carry an unsafe, thereby exempting vessels too observer if requested. However, NMFS to the requirements of the Paperwork small to accommodate an observer from Reduction Act, unless that collection of would only request a fraction of the this requirement. As a result of this total number of participants to carry an information displays a currently valid certification, an initial regulatory OMB Control Number. observer based on the sampling protocol flexibility analysis is not required and This proposed rule has been identified for each fishery by regional was not prepared. observer programs. As noted throughout This proposed rule would amend an determined to be not significant for the this proposed rule, NMFS would select existing collection-of-information that purposes of Executive Order 12866. vessels and focus coverage in times and was approved by the Office of An environmental assessment (EA) areas where fishing effort overlaps with Management and Budget (OMB) under was prepared under the National sea turtle distribution. Due to the OMB control number 0648–0593. This Environmental Policy Act (NEPA) for unpredictability of fishing effort, NMFS requirement will be submitted to OMB regulations to implement this observer cannot determine the specific number of for approval. This proposed rule would requirement in 50 CFR part 222, subpart vessels that would be requested to carry add an estimated 853 participants and D. The EA concluded that implementing an observer. an estimated maximum 60 burden hours these regulations would not have a If a vessel is requested to carry an to the associated information collection. significant impact on the human observer, fishers will not incur any Public comment is sought regarding: environment. This proposed rule would direct economic costs associated with whether this proposed collection of not make any significant change in the carrying that observer. Potential indirect information is necessary for the proper management of fisheries included on costs to individual fishers required to performance of the functions of the the AD, and therefore, this proposed take observers may include: lost space agency, including whether the rule would not change the analysis or on deck for catch, lost bunk space, and information shall have practical utility; conclusion of the EA. If NMFS takes a lost fishing time due to time needed to the accuracy of the burden estimate; management action, for example, process bycatch data. For effective ways to enhance the quality, utility, and requiring fishing gear modifications monitoring, however, observers will clarity of the information to be such as TEDs, NMFS would first rotate among a limited number of collected; and ways to minimize the prepare an environmental document as
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required under NEPA and specific to the fisheries interacting with sea turtles trawl gear, 2004–2005, and in sea that action. through information collected from scallop dredge gear, 2005. U.S. Dep. This proposed rule would not affect observer programs. Commer., Northeast Fish. Sci. Cent. Ref. species listed as threatened or This proposed rule would not affect Doc. 07–04; 30 p. Available from: endangered under the Endangered the land or water uses or natural National Marine Fisheries Service, 166 Species Act (ESA) or their associated resources of the coastal zone, as Water Street, Woods Hole, MA 02543– critical habitat. The impacts of specified under section 307 of the 1026. numerous fisheries have been analyzed Coastal Zone Management Act. Murray, K.T. 2009. Characteristics in various biological opinions, and this Literature Cited and magnitude of sea turtle bycatch in US mid-Atlantic gillnet gear. proposed rule would not affect the Lutcavage, M. E. and P.L. Lutz. 1997. conclusions of those opinions. The Endangered Species Research 8:211– Diving Physiology. In: P.L. Lutz and J. 224. inclusion of fisheries on the AD is not Musick (eds.) The Biology of Sea considered to be a management action National Marine Fisheries Service. Turtles. ERC Press, Boca Raton, F.L. 432 2009. Draft 2009 Marine Mammal Stock that would adversely affect threatened pp. or endangered species. If NMFS takes a Assessment Reports for the Atlantic Murray K.T. 2008. Estimated average Ocean and Gulf of Mexico. http:// management action, for example, annual bycatch of loggerhead sea turtles requiring modifications to fishing gear www.nmfs.noaa.gov/pr/pdfs/sars/ (Caretta caretta) in U.S. Mid-Atlantic ao2009_draft_appendices.pdf and/or practices, NMFS would review bottom otter trawl gear, 1996–2004 the action for potential adverse affects to (Second Edition). US Dept Commer, Dated: November 13, 2009. listed species under the ESA. Northeast Fish Sci Cent Ref Doc. 08–20; Janes W. Balsiger, This proposed rule would have no 32 p. Acting Assistant Administrator for Fisheries, adverse impacts on sea turtles and may Murray K.T. 2007. Estimated bycatch National Marine Fisheries Service. have a positive impact on sea turtles by of loggerhead sea turtles (Caretta [FR Doc. E9–27674 Filed 11–16–09; 8:45 am] improving knowledge of sea turtles and caretta) in U.S. Mid-Atlantic scallop BILLING CODE 3510–22–S
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Notices Federal Register Vol. 74, No. 221
Wednesday, November 18, 2009
This section of the FEDERAL REGISTER 703–305–2746 or via e-mail to wichq- USDA published a final rulemaking contains documents other than rules or [email protected]. Comments will also on the SFMNP on December 6, 2006 (71 proposed rules that are applicable to the be accepted through the Federal FR 74618), that contained an estimated public. Notices of hearings and investigations, eRulemaking Portal. Go to http:// information collection burden based on committee meetings, agency decisions and www.regulations.gov, and follow the the rule’s requirements for program rulings, delegations of authority, filing of petitions and applications and agency online instructions for submitting operation and administration. The statements of organization and functions are comments electronically. initial SFMNP information collection examples of documents appearing in this All written comments will be open for burden was approved by the Office of section. public inspection at the office of the Management and Budget (OMB) for 3 Food and Nutrition Service during years, effective January, 2007, under regular business hours (8:30 a.m. to 5 RIN 0584–0541. The Department is now DEPARTMENT OF AGRICULTURE p.m. Monday through Friday) at 3101 soliciting comments on the accuracy Park Center Drive, Room 522, and reasonableness of this estimated Food and Nutrition Service Alexandria, Virginia 22302. burden since the original SFMNP rulemaking. Agency Information Collection All responses to this notice will be Activities: Proposed Collection; summarized and included in the request Burden Estimate Comment Request—Senior Farmers’ for Office of Management and Budget 1. Reporting Market Nutrition Program (SFMNP) approval. All comments will be a matter of public record. Affected Public: Respondents include AGENCY: Food and Nutrition Service FOR FURTHER INFORMATION CONTACT: State agencies, local agencies, (FNS), USDA. Requests for additional information or individuals/households (participants), ACTION: Notice. copies of this information collection and authorized SFMNP farms (farmers, should be directed to Sandra Clark, farmers’ markets, roadside stands, and SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this Chief, Policy and Program Development CSA programs). notice invites the general public and Branch at 703–305–2746. Estimated Number of Respondents: other public agencies to comment on SUPPLEMENTARY INFORMATION: The total estimated number of this proposed information collection. Title: Senior Farmers’ Market respondents is 970,906. This includes: This is a revision of a currently Nutrition Program. State agencies, local agencies, approved collection for the Senior Form Number: FNS 683A. individuals/households (participants), and authorized SFMNP farms (farmers, Farmers’ Market Nutrition Program OMB Number: 0584–0541. farmers’ markets, roadside stands, and (SFMNP). Expiration Date: 1/31/2010. CSA programs). DATES: Written comments must be Type of Request: Revision of a Estimated Number of Responses per received on or before January 19, 2010. currently approved collection. Respondent: 1. ADDRESSES: Comments are invited on: Abstract: Section 4231 of the Food, Estimated Total Annual Responses: (a) Whether the proposed collection of Conservation and Energy Act of 2008 1,934,836. information is necessary for the proper (Pub. L. 110–246, also known as the Estimated Time per Response: .17. performance of the functions of the Farm Bill) reauthorized the SFMNP The estimated time of response varies agency, including whether the through FY 2012; a prior law (the Farm from 15 minutes to 40 hours depending information shall have practical utility; Security and Rural Investment Act of on respondent group. (b) the accuracy of the agency’s estimate 2002 (Pub. L. 107–171)) gave the Estimated Total Annual Burden on of the burden of the proposed collection Department of Agriculture the authority Respondents: 15,273,240 minutes of information, including the validity of to promulgate regulations for the (254,554 hours). See the table below for the methodology and assumptions that operation and administration of the estimated total annual burden for each were used; (c) ways to enhance the Senior Farmers’ Market Nutrition type of respondent. quality, utility, and clarity of the Program (SFMNP). These regulations are information to be collected; and (d) published at 7 CFR part 249. The 2. Recordkeeping ways to minimize the burden of the purposes of the SFMNP are to provide Estimated Number of Recordkeepings: collection of information on those who resources in the form of fresh, 963,930. are to respond, including use of nutritious, unprepared, locally grown Respondents include: State and local appropriate automated, electronic, fruits, vegetables, honey and herbs from agencies. mechanical, or other technological farmers’ markets, roadside stands, and Estimated Average Number of collection techniques or other forms of community supported agriculture (CSA) Recordkeepings per Respondent: 1. information technology. programs to low income seniors; to Estimated Time per Recordkeeping: 8 Comments may be sent to: Sandra increase the domestic consumption of hours. Clark, Chief, Policy and Program agricultural commodities by expanding Estimated Total Annual Burden on Development Branch, Food and or aiding in the domestic farmers’ Respondents: 243,224. Nutrition Service, U.S. Department of markets, roadside stands, and CSA The estimated time of response varies Agriculture, 3101 Park Center Drive, programs; and to develop or aid in the from 15 minutes to 40 hours depending Room 528, Alexandria, VA 22302. development of new and additional on respondent group. Comments may also be submitted via farmers’ markets, roadside stands, and Estimated Total Annual Reporting/ fax to the attention of Margarita Ray at CSA programs. Recordkeeping Requirements: 497,778
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hours. See the table below for estimated total annual burden for each type of respondent.
VerDate Nov<24>2008 16:30 Nov 17, 2009 Jkt 220001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1 mstockstill on DSKH9S0YB1PROD with NOTICES 59522 Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices hrs Annual burden .5 881 .25 240,921 .25 240,921 0 800 response Estimated hrs/ 5 245 2 98 response Total annual 12 10 120 12 ...... 1,934,836 ...... 497,778 annually Reports filed ...... 963,930 ...... 243,224 9 1 49 10 490 49 9 1 1 ...... 1,351 5,870 1 .17 5,870 0 1 7,763 0 ...... 5,870 ...... 5,870 1,960 40 49 9 1 49 1 49 2 49 98 49 1 685 ...... 963,685 ...... 240,921 Estimated spondents number of re- . 970,906 ...... 970,906 ...... 254,554 2 49 98 49 1 ...2 980 490 490 1 ....1 587 587 1 ....0 963,685 963,685 1 .....1,960 40 49 49 1 ...... 3 147 49 49 1 ...... 15 180 12 12 1 ...... 0 963,685 963,685 1 ...... 1 49 49 49 1 ...... 1,960 40 49 49 1 Affected Public: Farms (Farmers/Markets/Roadside stands/CSAs) Affected Public: INDIVIDUALS/HOUSEHOLDS (Applicants for Program Benefits) Affected Public: STATE & LOCAL AGENCIES (Including Indian Tribal Organizations and U.S. Territories) Affected Public: STATE & LOCAL AGENCIES (Including Indian Tribal Organizations and U.S. Territories) Regulation section Title Forms Subtotal ...... (Reporting Requirements) ...... Subtotal 1,35 ...... (Reporting Requirements) ...... 963, Subtotal ...... (Reporting Requirements) ...... GRAND SUBTOTAL ...... 5,87 Subtotal ...... (Recordkeeping Requirements) ...... TOTAL BURDEN ...... (Reporting & Recordkeeping) ...... 963,930 1,934,836 ...... Reporting 249.3(e) ...... 249.4 Local Agency Applications ...... 249.10(e) State Plan ...... 249.10(f) Monitoring/review of outlets ...... 249.10(h) Coupon/CSA management system ...... 249.11 Coupon reconciliation ...... 249.12 Financial management system ...... 249.17(b)(2) ...... Prior Approval for costs per 7 CFR 3016.22 ...... 249.18(b) State agency corrective action plans ...... 249.23(b) Audit responses ...... Financial/recipient reports ...... 49 ...... 4 Reporting 5 12 249.6(a)(3) ...... 1 Certification data for seniors ...... 1 1 Reporting 49 249.10(b) ...... Farmer applications & agreements ...... 5 5,87 Recordkeeping 16 249.9 ...... 249.10(b) Nutrition education ...... 249.10(e) Authorized outlet agreements ...... 249.11 Summary of authorized outlet monitoring ...... 249.16(a) Record of financial expenditures ...... 249.23(a) Fair hearings ...... Record of program operations ...... 49 4 1 49
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Dated: November 10, 2009. requires the Department to gather and distribute photo-electronic industrial Julia Paradis, analyze a significant amount of automation sensors, safety systems, and Administrator, Food and Nutrition Service. information pertaining to the company’s automatic identification products [FR Doc. E9–27600 Filed 11–17–09; 8:45 am] sales practices, manufacturing costs and (classified under HTSUS 8541.40) for BILLING CODE 3410–30–P corporate relationships, which is the U.S. market and export. At full complicated due to the manner in capacity the plant can manufacture up which the inputs for making brass sheet to 50,000 units annually. Activity under DEPARTMENT OF COMMERCE and strip are purchased and the FTZ procedures would include processes by which brass sheet and strip manufacturing, testing, inspection, and International Trade Administration are sold. Furthermore, the respondent, packaging. Components to be purchased Wieland, has proposed that the from abroad (representing about 30% of A–428–602 Department use an alternative cost the value of the finished sensors) would methodology to account for the Brass Sheet and Strip from Germany: include plates/sheets/film/foil of volatility in the material costs that Notice of Extension of Time Limit for polycarbonates, fasteners, parts of affects our analysis and requires an Preliminary Results of Administrative circuit breakers, and electrical examination of a significant amount of Review conductors (duty rate range: 2.6–8.5%). data. Given the number and complexity The application indicates that SICK AGENCY: Import Administration, of issues in this case, and in accordance would also admit foreign-origin photo- International Trade Administration, with section 751(a)(3)(A) of the Act, we electronic sensors and related Department of Commerce. are extending the time period for issuing components to the proposed subzone for EFFECTIVE DATE: November 18, 2009. the preliminary results of review by 120 domestic distribution and export. days. Therefore, the preliminary results FOR FURTHER INFORMATION CONTACT: FTZ procedures could exempt SICK are now due no later than March 31, Dennis McClure or George McMahon at from customs duty payments on the 2010. The final results continue to be foreign components used in export (202) 482–5973 and (202) 482–1167, due 120 days after the date of respectively; AD/CVD Operations, production. On domestic shipments, the publication of the preliminary results. company would be able to elect the duty Office 3, Import Administration, We are issuing and publishing this International Trade Administration, rate that applies to finished photo- notice in accordance with sections electronic sensors (free) for the foreign U.S. Department of Commerce, 14th 751(a)(3)(A) and 777(i)(1) of the Act. Street and Constitution Avenue, NW, inputs noted above. Subzone status Washington, DC 20230. Dated: November 10, 2009. would further allow SICK to realize John M. Andersen, logistical benefits through the use of SUPPLEMENTARY INFORMATION: Acting Deputy Assistant Secretary for weekly customs entry procedures. Background Antidumping and Countervailing Duty Customs duties could possibly be Operations. On April 27, 2009, the Department of deferred or reduced on foreign status Commerce (the ‘‘Department’’) initiated [FR Doc. E9–27670 Filed 11–17–09; 8:45 am] production equipment. The application an administrative review of the BILLING CODE 3510–DS–S indicates that the savings from FTZ antidumping duty order on brass sheet procedures would help improve the facility’s international competitiveness. and strip from Germany with respect to DEPARTMENT OF COMMERCE Wieland–Werke AG (Wieland). See In accordance with the Board’s regulations, Pierre Duy of the FTZ Staff Initiation of Antidumping and Foreign-Trade Zones Board Countervailing Duty Administrative is designated examiner to evaluate and Reviews and Request for Revocation in [Docket 49–2009] analyze the facts and information presented in the application and case Part, 74 FR 19042 (April 27, 2009). Foreign-Trade Zone 119—Minneapolis, The period of review (POR) is March record and to report findings and MN; Application for Subzone SICK, Inc. 1, 2008, through February 28, 2009. The recommendations to the Board. (Photo-Electronic Industrial Sensors); Public comment is invited from preliminary results of this review are Bloomington, MN currently due no later than December 1, interested parties. Submissions (original 2009. An application has been submitted to and 3 copies) shall be addressed to the the Foreign-Trade Zones Board (the Board’s Executive Secretary at the Extension of Time Limits for Board) by the Greater Metropolitan Area following address: Office of the Preliminary Results Foreign Trade Zone Commission Executive Secretary, Room 2111, U.S. Section 751(a)(3)(A) of the Tariff Act (Minneapolis, Minnesota), grantee of Department of Commerce, 1401 of 1930, as amended (the Act), requires FTZ 119, requesting special-purpose Constitution Avenue, NW., Washington, the Department to make a preliminary subzone status for the photo-electronic DC 20230–0002. The closing period for determination within 245 days after the industrial sensor manufacturing facility receipt of comments is January 19, 2010. last day of the anniversary month of an of SICK, Inc. (SICK), located in Rebuttal comments in response to order or finding for which a review is Bloomington, Minnesota. The material submitted during the foregoing requested. Section 751(a)(3)(A) of the application was submitted pursuant to period may be submitted during the Act further states that if it is not the provisions of the Foreign-Trade subsequent 15-day period to February 1, practicable to complete the review Zones Act, as amended (19 U.S.C. 81a– 2010. within the time period specified, the 81u), and the regulations of the Board A copy of the application will be administering authority may extend the (15 CFR part 400). It was formally filed available for public inspection at the 245–day period to issue its preliminary on November 10, 2009. Office of the Foreign-Trade Zones results by up to 120 days. The SICK facility (300 employees/ Board’s Executive Secretary at the We determine that completion of the 55,207 sq.ft./3.2 acres) is located at 6900 address listed above and in the preliminary results of this review within West 110th Street, Bloomington ‘‘Reading Room’’ section of the Board’s the 245–day period is not practicable for (Hennepin County), Minnesota. The Web site, which is accessible via the following reasons. This review facility is used to manufacture and http://www.trade.gov/ftz.
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For Further Information Contact: cabs, 90,000 drivetrain units, 140,000 Board’s Executive Secretary at the Pierre Duy at [email protected] or tons of foundry products, and $150 address below. The closing period for (202) 482–1378. million of service parts and their receipt is January 19, 2010. Dated: November 10, 2009. components. Components and materials Rebuttal comments in response to sourced from abroad (representing 13 to Andrew McGilvray, material submitted during the foregoing 18% of the value of the finished period may be submitted during the Executive Secretary. products) include: putty and caulking subsequent 15-day period to February 1, [FR Doc. E9–27681 Filed 11–17–09; 8:45 am] compounds; glues and adhesives; self- 2010. BILLING CODE 3510–DS–P adhesive plates; articles of plastic (incl. A copy of the application will be tubes, hoses, fittings, stoppers and lids); available for public inspection at the articles of rubber (incl. belts, tubes, Office of the Executive Secretary, DEPARTMENT OF COMMERCE hoses, grommets, plugs, mountings, Foreign-Trade Zones Board, Room 2111, Foreign-Trade Zones Board sheets, strips); tires; floor coverings and U.S. Department of Commerce, 1401 mats; mirrors; gaskets; washers; Constitution Avenue, NW., Washington, [Docket 50–2009] paperboard; safety glass; iron tubes; DC 20230–0002, and in the ‘‘Reading pipes and fittings; chain; fasteners; Room’’ section of the Board’s Web site, Foreign-Trade Zone 175—Cedar springs; articles of copper; articles of which is accessible via http:// Rapids, IA; Application for Subzone; steel; base metal mountings; sign plates; www.trade.gov/ftz. Deere & Company (Agricultural internal-combustion engines and parts; For Further Information Contact: Tractors and Related Components pumps; air conditioner components; Diane Finver at [email protected] Manufacturing); Waterloo, IA refrigerators; filters; spraying machines; or (202) 482–1367. agricultural machinery and parts; An application has been submitted to Dated: November 12, 2009. the Foreign-Trade Zones Board (the valves; bearings; transmission shafts; electric motors; generators; clutches; Andrew McGilvray, Board) by the Cedar Rapids Airport Executive Secretary. Commission, grantee of FTZ 175, brakes; ignitions; electromagnetic couplings; gears; flywheels; pulleys; [FR Doc. E9–27683 Filed 11–17–09; 8:45 am] requesting special-purpose subzone antennas; windshield wipers; electrical BILLING CODE 3510–DS–P status for the agricultural tractors, cabs, lighting or signaling equipment; engines and components manufacturing loudspeakers; heaters; defrosters; facilities of Deere & Company (Deere), alarms; radios; clocks; resistors; DEPARTMENT OF COMMERCE located in Waterloo, Iowa. The switches; relays; lamps; wires; cables; application was submitted pursuant to National Oceanic and Atmospheric seats; locks and keys; discs; tapes and the provisions of the Foreign-Trade Administration media storage; motor vehicle parts and Zones Act, as amended (19 U.S.C. 81a- accessories; gauges; measuring RIN 0648–XS95 81u), and the regulations of the Board instruments; geophysical instruments (15 CFR part 400). It was formally filed and appliances; desk equipment and Marine Mammals; Photography Permit on November 12, 2009. parts (duty rates—free to 12.2%). Application No. 15128 The Deere facilities (approximately FTZ procedures could exempt Deere AGENCY: National Marine Fisheries 4,000 employees) consist of 6 sites on from customs duty payments on the Service (NMFS), National Oceanic and approximately 1,437.58 acres in foreign components used in export Waterloo, Iowa: Site 1 (1,002.41 acres, production. The company anticipates Atmospheric Administration (NOAA), 2,000,000 enclosed square feet) tractor that some 30 to 35 percent of the Commerce. and cab assembly operations located at facilities’ shipments will be exported. ACTION: Notice; receipt of application. 3500 E. Donald Street; Site 2 (257.63 On its domestic sales, Deere would be SUMMARY: Notice is hereby given that acres, 3,000,000 enclosed square feet) able to choose the duty rates during Robert Pilley, Leighside, Bridge Road, drivetrain, foundry & service parts customs entry procedures that apply to Leighwoods, Bristol, BS8 3PB, United operations located at 400 and 2000 its finished products (duty rates range Kingdom, has applied in due form for a Westfield Ave.; Site 3 (26.22 acres, between free and 8.6%) for the foreign permit to conduct commercial/ 276,480 enclosed square feet) Ryder inputs noted above. FTZ designation educational photography of bottlenose warehouse and servicing facility located would further allow Deere to realize dolphins (Tursiops truncatus). at 2280 Northeast Drive; Site 4 (25 acres, scrap benefits and certain logistical 166,000 square feet) Waterloo benefits through the use of customs DATES: Written, telefaxed, or e-mail warehouse located at 1519 W. Airline procedures. Customs duties also could comments must be received on or before Hwy.; Site 5 (20.37 acres, 242,240 possibly be deferred or reduced on December 18, 2009. square feet) FirstCo warehouse located foreign status production equipment. ADDRESSES: The application and related at 3470 W. Airline Hwy.; and Site 6 The request indicates that the savings documents are available for review (105.95 acres, 1,137,213 enclosed square from FTZ procedures would help upon written request or by appointment feet) Engine Works facility located at improve the plant’s international in the following offices: 3801 W. Ridgeway Ave. The facilities competitiveness. Permits, Conservation and Education are used for the manufacture, testing, In accordance with the Board’s Division, Office of Protected Resources, warehousing and distribution of: regulations, Diane Finver of the FTZ NMFS, 1315 East-West Highway, Room Medium and large row crop tractors Staff is designated examiner to evaluate 13705, Silver Spring, MD 20910; phone (wheel and track versions); cab and analyze the facts and information (301)713–2289; fax (301)713–0376; and assemblies; marine and industrial diesel presented in the application and case Southeast Region, NMFS, 263 13th engines; drivetrain components; wheel record and to report findings and Avenue South, Saint Petersburg, Florida assemblies; cast iron forgings; and, parts recommendations to the Board. 33701; phone (727)824–5312; fax and components for these products. The Public comment is invited from (727)824–5309. Deere facilities annually can produce up interested parties. Submissions (original Written comments or requests for a to 45,000 tractors and engines, 45,000 and 3 copies) shall be addressed to the public hearing on this application
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should be mailed to the Chief, Permits, NMFS is forwarding copies of this individuals requesting a hearing should Conservation and Education Division, application to the Marine Mammal set forth the specific reasons why a F/PR1, Office of Protected Resources, Commission and its Committee of hearing on this particular request would NMFS, 1315 East-West Highway, Room Scientific Advisors. be appropriate. 13705, Silver Spring, MD 20910. Those Dated: November 13, 2009. Comments may also be submitted by individuals requesting a hearing should P. Michael Payne, facsimile at (301)713–0376, provided set forth the specific reasons why a Chief, Permits, Conservation and Education the facsimile is confirmed by hard copy hearing on this particular request would Division, Office of Protected Resources, submitted by mail and postmarked no be appropriate. National Marine Fisheries Service. later than the closing date of the Comments may also be submitted by [FR Doc. E9–27676 Filed 11–17–09; 8:45 am] comment period. facsimile at (301)713–0376, provided BILLING CODE 3510–22–S Comments may also be submitted by the facsimile is confirmed by hard copy e-mail. The mailbox address for submitted by mail and postmarked no providing e-mail comments is later than the closing date of the DEPARTMENT OF COMMERCE [email protected]. Include comment period. in the subject line of the e-mail Comments may also be submitted by National Oceanic and Atmospheric comment the following document e-mail. The mailbox address for Administration identifier: File No. 14510. providing e-mail comments is [email protected]. Include RIN 0648–XR86 FOR FURTHER INFORMATION CONTACT: Patrick Opay or Kate Swails, (301)713– in the subject line of the e-mail Endangered Species; File No. 14510 comment the following document 2289. identifier: File No. 15128. AGENCY: National Marine Fisheries SUPPLEMENTARY INFORMATION: The FOR FURTHER INFORMATION CONTACT: Service (NMFS), National Oceanic and subject permit is requested under the Amy Hapeman or Carrie Hubard, Atmospheric Administration (NOAA), authority of the Endangered Species Act (301)713–2289. Commerce. of 1973, as amended (ESA; 16 U.S.C. SUPPLEMENTARY INFORMATION: The ACTION: Notice; receipt of application. 1531 et seq.) and the regulations subject permit is requested under the governing the taking, importing, and SUMMARY: Notice is hereby given that authority of section 104(c)(6) of the exporting of endangered and threatened NMFS Southwest Fisheries Science Marine Mammal Protection Act of 1972, species (50 CFR 222–226). Center, 3333 North Torrey Pines Court, as amended (16 U.S.C. 1361 et seq.), the The purpose of the proposed research La Jolla, CA 92037–1023, has applied in regulations governing the taking and project is to initiate a baseline study of due form for a permit to take green importing of marine mammals (50 CFR the status of sea turtles in the San (Chelonia mydas), loggerhead (Caretta part 216). Section 104(c)(6) provides for Gabriel River and Alamitos Bay in Long caretta), olive ridley (Lepidochelys photography for educational or Beach, California. Researchers would olivacea), and leatherback (Dermochelys commercial purposes involving non- also opportunistically take samples and coriacea) sea turtles for scientific endangered and non-threatened marine potentially track sea turtles incidentally research. mammals in the wild. taken in coastal power plants off Mr. Pilley requests a two-year DATES: Written, telefaxed, or e-mail California and that strand live in the photography permit to film bottlenose comments must be received on or before marine environment. The applicant dolphin strand feeding events in the December 18, 2009. would study abundance, size ranges, estuaries and creeks of Bull Creek and ADDRESSES: The application and related growth, sex ratio, health status, diving around Hilton Head, South Carolina. documents are available for review by behavior, local movements, habitat use, Filmmakers plan to use four filming selecting ‘‘Records Open for Public migration routes, and contaminant platforms: a static remotely operated Comment’’ from the Features box on the levels. Researchers would track the camera placed on the mudflats, a radio- Applications and Permits for Protected movements of healthy turtles released controlled camera helicopter, a radio- Species (APPS) home page, https:// off the coast of California to determine controlled camera glider, and a radio- apps.nmfs.noaa.gov, and then selecting their movements locally and/or controlled camera boat. Up to 128 File No. 14510 from the list of available offshore. Researchers would annually dolphins annually may be approached applications. These documents are also capture, measure, weigh, photograph/ and filmed. Filming will occur over 14 available for review upon written video, flipper tag, passive integrated days and be completed by November request or by appointment in the transponder tag (PIT), tissue biopsy, 2010. Footage will be used to create a following offices: blood sample, scute scrape, lavage, 6–part television series, Earthflight, for Permits, Conservation and Education ultrasound, oral swab, cloacal swab, the British Broadcasting Corporation Division, Office of Protected Resources, inject tetracycline, and release up to 35 and Discovery Channel. The premise of NMFS, 1315 East-West Highway, Room green, six loggerhead, and six olive the series is to follow migratory bird 13705, Silver Spring, MD 20910; phone ridley sea turtles during captures as part species around the world, with a bird’s- (301)713–2289; fax (301)713–0376; and of the San Gabriel and Los Alamitos Bay eye perspective. Southwest Region, NMFS, 501 West California project. Fifteen of the 35 In compliance with the National Ocean Blvd., Suite 4200, Long Beach, green sea turtles would have a sonic Environmental Policy Act of 1969 (42 CA 90802–4213; phone (562)980–4001; transmitter attached, five of the green U.S.C. 4321 et seq.), an initial fax (562)980–4018. sea turtles would have a satellite determination has been made that the Written comments or requests for a transmitter attached, five would have a activity proposed is categorically public hearing on this application sonic transmitter and camera attached, excluded from the requirement to should be mailed to the Chief, Permits, and five would have a sonic transmitter prepare an environmental assessment or Conservation and Education Division, and time depth recorder attached. One environmental impact statement. F/PR1, Office of Protected Resources, of the loggerhead sea turtles and two of Concurrent with the publication of NMFS, 1315 East-West Highway, Room the olive ridley sea turtles would also this notice in the Federal Register, 13705, Silver Spring, MD 20910. Those have a satellite transmitter attached.
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Researchers would also annually an administrative review of the liquidation of the relevant entries measure, weigh, photograph/video, countervailing duty (CVD) order on PET during this review period. Failure to flipper tag, PIT tag, tissue biopsy, blood Film from India covering one producer/ comply with this requirement could sample, scute scrape, lavage, exporter of subject merchandise, Jindal result in the Secretary’s presumption ultrasound, oral swab, cloacal swab, Poly Films Limited of India (Jindal), for that reimbursement of the antidumping inject tetracycline, transport, and release the period January 1, 2008, through duties occurred and the subsequent up to ten green, one olive ridley, and December 31, 2008. See Initiation of assessment of double antidumping three loggerhead sea turtles taken in Antidumping and Countervailing Duty duties. power plant entrainments. Three of the Administrative Reviews and Requests Notification Regarding Administrative loggerheads, the one olive ridley, and for Revocation in Part, 73 FR 50308 Protective Orders one of the loggerhead sea turtles would (August 26, 2008) (Initiation Notice). On also have a satellite transmitter October 26, 2009, Jindal filed a timely This notice also serves as a reminder attached. Researchers would also have withdrawal from its request for a to parties subject to administrative authority to salvage, necropsy, and countervailing duty administrative protective orders (APO) of their sample animals that die as a result of review, in accordance with 19 CFR responsibility concerning the return or entrainment. 351.213(d)(1). Jindal is the only destruction of proprietary information Researches would also annually respondent in this review. Petitioners1 disclosed under APO in accordance measure, weigh, photograph/video, did not file a request for a review. with 19 CFR 351.305, which continues flipper tag, PIT tag, tissue biopsy, blood to govern business proprietary Rescission of Review sample, scute scrape, lavage, information in this segment of the ultrasound, oral swab, cloacal swab, The Department’s regulations at 19 proceeding. Timely written notification transport, and release up to four green, CFR 351.213(d)(1) provide that the of the return/destruction of APO one olive ridley, one loggerhead, and Department will rescind an materials or conversion to judicial two leatherback sea turtles that strand in administrative review if the party that protective order is hereby requested. the marine environment. One of the requested the review withdraws its Failure to comply with the regulations green, the olive ridley, and the request for review within 90 days of the and terms of an APO is a violation loggerhead would have a satellite date of publication of the notice of which may be subject to sanctions. transmitter attached. The leatherbacks initiation of the requested review, or This notice is issued and published in would have a camera attached. withdraws its request at a later date if accordance with section 777(i)(1) of the Researchers would also have authority the Department determines that it is Tariff Act of 1930, as amended (the Act), to authority to salvage, necropsy, and reasonable to extend the time limit for and 19 CFR 351.213(d)(4). sample animals that die as a result of withdrawing the request. Jindal Dated: November 10, 2009. stranding. The applicant requests a five submitted its request within the 90 day John M. Andersen, limit set by the regulations. Since no year permit. Acting Deputy Assistant Secretary for Dated: November 12, 2009. other parties requested a review of Antidumping and Countervailing Duty Jindal, the Department is rescinding, the P. Michael Payne, Operations. administrative review of the [FR Doc. E9–27679 Filed 11–17–09; 8:45 am] Chief, Permits, Conservation and Education countervailing duty order on PET Film Division, Office of Protected Resources, BILLING CODE 3510–DS–S National Marine Fisheries Service. from India for the period January 1, 2008, through December 31, 2008, for [FR Doc. E9–27677 Filed 11–17–09; 8:45 am] Jindal. BILLING CODE 3510–22–S DEPARTMENT OF COMMERCE Assessment Rates National Oceanic and Atmospheric The Department will instruct U.S. DEPARTMENT OF COMMERCE Administration Customs and Border Protection (CBP) to International Trade Administration assess countervailing duties on all RIN: 0648–XS94 appropriate entries. Jindal shall be (C–533–825) assessed countervailing duty rates equal Gulf of Mexico Fishery Management to the cash deposit of the estimated Council; Public Meeting Polyethylene Terephthalate Film, countervailing duties required at the Sheet, and Strip (PET Film) from India: AGENCY: National Marine Fisheries time of entry, or withdrawal from Rescission of Countervailing Duty Service (NMFS), National Oceanic and warehouse, for consumption, in Administrative Review Atmospheric Administration (NOAA), accordance with 19 CFR Commerce. 351.212(c)(1)(i). The Department will AGENCY: Import Administration, ACTION: Notice of a public meeting. International Trade Administration, issue appropriate assessment Department of Commerce. instructions directly to CBP within 15 SUMMARY: The Gulf of Mexico Fishery FOR FURTHER INFORMATION CONTACT: Elfi days of publication of this notice. Management Council will convene a Blum, AD/CVD Operations, Office 6, Notification to Importers meeting of its Ecosystem Scientific and Import Administration, International Statistical Committee. This notice serves as a final reminder Trade Administration, U.S. Department DATES: The Ecosystem and Statistical to importers for whom this review is of Commerce, 14th Street and Committee meeting will begin at 1 p.m. being rescinded of their responsibility Constitution Avenue, NW, Washington on Monday, December 7, 2009 and under 19 CFR 351.402(f)(2) to file a DC 20230; telephone: (202) 482–0197. conclude by 12 p.m. on Tuesday, certificate regarding the reimbursement December 8, 2009. The meeting will be SUPPLEMENTARY INFORMATION: of antidumping duties prior to webcast over the internet. A link to the Background 1 Dupont Teijin Films, Mitsubishi Polyester Film webcast will be available on the On August 25, 2009, the Department of America, and Toray Plastics (America), Inc. Council’s web site, http:// of Commerce (the Department) initiated (collectively, Petitioners). www.gulfcouncil.org.
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ADDRESSES: The meeting will be held at DEPARTMENT OF DEFENSE public. Accordingly, the Secretary of the the Crowne Plaza, 5303 W. Kennedy Navy has determined in writing that the Blvd., Tampa, FL 33609. Department of the Navy meeting shall be partially closed to the public because the discussions during Council address: Gulf of Mexico Notice of Partially Closed Meeting of Fishery Management Council, 2203 the executive session from 11 a.m. to 12 the U.S. Naval Academy Board of p.m. will be concerned with matters North Lois Avenue, Suite 1100, Tampa, Visitors FL 33607. coming under sections 552b(c)(5), (6), AGENCY: Department of the Navy, DOD. and (7) of title 5, United States Code. FOR FURTHER INFORMATION CONTACT: Dr. Dated: November 6, 2009. Karen Burns, Ecosystems Management ACTION: Notice. Specialist, Gulf of Mexico Fishery A. M. Vallandingham SUMMARY: The U.S. Naval Academy Lieutenant Commander, Judge Advocate Management Council; telephone: (813) Board of Visitors will meet to make such 348–1630. General’s Corps, U.S. Navy, Federal Register inquiry, as the Board shall deem Liaison Officer. SUPPLEMENTARY INFORMATION: The necessary into the state of morale and [FR Doc. E9–27682 Filed 11–17–09; 8:45 am] Ecosystem and Statistical Committee discipline, the curriculum, instruction, BILLING CODE 3810–FF–P will begin developing a conceptual physical equipment, fiscal affairs, and framework for advancing an ecosystem academic methods of the Naval approach for fishery management. They Academy. The executive session of this DEPARTMENT OF EDUCATION will also explore the use of ecological meeting from 11 a.m. to 12 p.m. on attributes in the Allowable Biological December 7, 2009, will include Office of Postsecondary Education; Catch Control Rule. There will also be discussions of disciplinary matters, law Overview Information; Business and an evaluation on the efficacy of various enforcement investigations into International Education (BIE) Program; models and approaches to determine allegations of criminal activity, and Notice Inviting Applications for New how recovering red snapper interact personnel-related issues at the Naval Awards for Fiscal Year (FY) 2010 with vermilion snapper and groupers Academy, the disclosure of which and future data and research needs for would constitute a clearly unwarranted Catalog of Federal Domestic these models. invasion of personal privacy. For this Assistance (CFDA) Number: 84.153A. reason, the executive session of this Dates: Applications Available: Copies of the agendas and other meeting will be closed to the public. November 18, 2009. related materials can be obtained by Deadline for Transmittal of calling (813) 348–1630 or can be DATES: The open sessions of the meeting will be held on Monday, December 7, Applications: January 8, 2010. downloaded from the Council’s ftp site, Deadline for Intergovernmental 2009, from 8 a.m. to 11 a.m. The closed ftp.gulfcouncil.org. Review: March 9, 2010. session of this meeting will be the Although other non-emergency issues executive session held from 11 a.m. to Full Text of Announcement not on the agendas may come before the 12 p.m. on December 7, 2009. and Statistical Committee for I. Funding Opportunity Description ADDRESSES: The meeting will be held in discussion, in accordance with the Purpose of Program: The BIE Program Magnuson-Stevens Fishery the Bo Coppedge Room of Alumni Hall, U.S. Naval Academy, Annapolis, MD. provides grants to enhance international Conservation and Management Act, business education programs and to those issues may not be the subject of The meeting will be handicap accessible. expand the capacity of the business formal action during these meetings. community to engage in international Actions of the and Statistical Committee FOR FURTHER INFORMATION CONTACT: economic activities. will be restricted to those issues Lieutenant Commander David S. Priorities: This notice includes two specifically identified in the agendas Forman, USN, Executive Secretary to competitive preference priorities and and any issues arising after publication the Board of Visitors, Office of the one invitational priority that are of this notice that require emergency Superintendent, U.S. Naval Academy, explained in the following paragraphs. action under Section 305(c) of the Annapolis, MD 21402–5000, (410) 293– Competitive Preference Priority: In Magnuson-Stevens Fishery 1503. accordance with 34 CFR 75.105(b)(2)(ii), Conservation and Management Act, SUPPLEMENTARY INFORMATION: This these priorities are from the regulations provided the public has been notified of notice of meeting is provided per the for this program (34 CFR 661.10 and the Council’s intent to take action to Federal Advisory Committee Act, as 661.32). For FY 2010, these priorities address the emergency. amended (5 U.S.C. App.). The executive are competitive preference priorities. Special Accommodations session of the meeting from 11 a.m. to Under 34 CFR 75.105(c)(2)(i) we award 12 p.m. on December 7, 2009, will up to an additional five points under These meetings are physically consist of discussions of law each priority to an application that accessible to people with disabilities. enforcement investigations into meets that priority. Requests for sign language allegations of criminal activity, new and These priorities are: interpretation or other auxiliary aids pending administrative/minor Competitive Preference Priority I: should be directed to Tina O’Hern at the disciplinary infractions and nonjudicial Applications that propose projects that Council (see ADDRESSES) at least 5 punishments involving the Midshipmen provide innovation and improvement of working days prior to the meeting. attending the Naval Academy to include international education curricula to but not limited to individual honor/ serve the needs of the business Dated: November 13, 2009. conduct violations within the Brigade, community, including the development Tracey L. Thompson, and personnel-related issues. The of new programs for nontraditional, Acting Director, Office of Sustainable discussion of such information cannot mid-career, or part-time students. Fisheries, National Marine Fisheries Service. be adequately segregated from other Competitive Preference Priority II: [FR Doc. E9–27690 Filed 11–17–09; 8:45 am] topics, which precludes opening the Applications that propose projects to BILLING CODE 3510–22–S executive session of this meeting to the internationalize curricula at junior and
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community colleges, and at account in developing this notice IV. Application and Submission undergraduate and graduate schools of inviting applications. A list of foreign Information business. languages and world regions identified 1. Address to Request Application Invitational Priority: For FY 2010, by the Secretary as areas of national Package: Tanyelle Richardson, there is one invitational priority for this need may be found on links on the International Education Programs program. Under 34 CFR 75.105(c)(1) we following Web sites: http://www.ed.gov/ Service, U.S. Department of Education, do not give an application that meets about/offices/list/ope/policy.html 1990 K Street, NW., room 6017, this invitational priority a competitive http://www.ed.gov/programs/iegpsbie/ Washington, DC 20006–8521. or absolute preference over other legislation.html. Telephone: (202) 502–7626 or by e-mail: applications. Also included on these Web sites and [email protected]. This priority is: links are the specific recommendations If you use a telecommunications Invitational Priority: the Secretary received from Federal device for the deaf (TDD), call the Applications that focus on language agencies. Federal Relay Service (FRS), toll free, at instruction in any of the following II. Award Information 1–800–877–8339. seventy-eight (78) languages selected Individuals with disabilities can Type of Award: Discretionary grants. from the U.S. Department of Education’s obtain a copy of the application package Estimated Available Funds: The list of Less Commonly Taught in an accessible format (e.g., braille, Administration has requested Languages (LCTLs): large print, audiotape, or computer $102,335,000 for the Title VI Akan (Twi-Fante), Albanian, diskette) by contacting the program International Education and Foreign Amharic, Arabic (all dialects), contact person listed in this section. Language Studies: Domestic Programs Armenian, Azeri (Azerbaijani), Balochi, 2. Content and Form of Application for FY 2010, of which we intend to Bamanakan (Bamana, Bambara, Submission: Requirements concerning allocate $2,152,000 for new awards Mandikan, Mandingo, Maninka, Dyula), the content of an application, together under this program. The actual level of Belarusian, Bengali (Bangla), Berber (all with the forms you must submit, are in funding, if any, depends on final languages), Bosnian, Bulgarian, the application package for this congressional action. However, we are Burmese, Cebuano (Visayan), Chechen, program. inviting applications to allow enough Chinese (Cantonese), Chinese (Gan), Page Limit: The application narrative time to complete the grant process if Chinese (Mandarin), Chinese (Min), is where you, the applicant, address the Congress appropriates funds for this Chinese (Wu), Croatian, Dari, Dinka, selection criteria that reviewers use to program. Georgian, Gujarati, Hausa, Hebrew evaluate your application. You must Estimated Range of Awards: $50,000– (Modern), Hindi, Igbo, Indonesian, limit the application narrative [Part III] $95,000. Japanese, Javanese, Kannada, Kashmiri, to no more than 40 pages, using the Estimated Average Size of Awards: Kazakh, Khmer (Cambodian), Kirghiz, following standards: $86,080. Korean, Kurdish (Kurmanji), Kurdish • A ‘‘page’’ is 8.5″ x 11″, on one side Maximum Award: We will reject any (Sorani), Lao, Malay (Bahasa Melayu or only, with 1″ margins at the top, bottom, application that proposes a budget Malaysian), Malayalam, Marathi, and both sides. Page numbers and an exceeding $95,000 for a single budget Mongolian, Nepali, Oromo, Panjabi, identifier may be outside of the 1’’ period of 12 months. The Assistant Pashto, Persian (Farsi), Polish, margin. Secretary for Postsecondary Education Portuguese (all varieties), Quechua, • Double space (no more than three may change the maximum amount Romanian, Russian, Serbian, Sinhala lines per vertical inch) all text in the through a notice published in the (Sinhalese), Somali, Swahili, Tagalog, application narrative, except titles, Federal Register. Tajik, Tamil, Telugu, Thai, Tibetan, headings, footnotes, quotations, Estimated Number of Awards: 25. Tigrigna, Turkish, Turkmen, Ukrainian, references, captions, and all text in Urdu, Uyghur/Uigur, Uzbek, Note: The Department is not bound by any charts, tables, figures, and graphs. These Vietnamese, Wolof, Xhosa, Yoruba, and estimates in this notice. items may be single-spaced. Charts, Zulu. Project Period: Up to 24 months. tables, figures, and graphs in the Program Authority: 20 U.S.C. 1130–1130b. application narrative count toward the III. Eligibility Information Applicable Regulations: (a) The page limit. 1. Eligible Applicants: Institutions of • Use a font that is either 12 point or Education Department General higher education that have entered into larger or no smaller than 10 pitch Administrative Regulations (EDGAR) in agreements with business enterprises, (characters per inch). However, you may 34 CFR parts 74, 75, 77, 79, 80, 81, 82, trade organizations, or associations that use a 10 point font in charts, tables, 84, 85, 86, 97, 98, and 99. (b) The are engaged in international economic figures, and graphs. regulations in 34 CFR parts 655 and 661. activity—or a combination or • Use one of the following fonts: Note: The regulations in 34 CFR part 86 consortium of these enterprises, Times New Roman, Courier, Courier apply to institutions of higher education organizations, or associations—for the New, or Arial. An application submitted only. purposes of pursuing the activities in any other font (including Times Areas of National Need: In authorized under this program. Roman and Arial Narrow) will not be accordance with section 601(c) of the 2. Cost Sharing or Matching: Section accepted. Higher Education Act of 1965, as 613(d) of the HEA, (20 U.S.C. 1130a(d)) The page limit does not apply to Part amended (HEA), 20 U.S.C. 1121(c), the provides that the applicant’s share of I, the Application for Federal Assistance Secretary has consulted with and the total cost of carrying out a program face sheet (SF 424); the supplemental received recommendations regarding supported by a grant under the BIE information form required by the the national need for expertise in Program must be no less than 50 percent Department of Education; Part II, the foreign languages and world regions of the total cost of the project in each budget information summary form (ED from the head officials of a wide range fiscal year. The non-Federal share of the Form 524); or Part IV, the assurances of Federal agencies. The Secretary has cost may be provided either in-kind or and certifications. The page limit also taken these recommendations into in cash. does not apply to a table of contents.
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However, the page limit does apply to accordance with the instructions in this Assistance (SF 424), the Department of all of the application narrative section section. Education Supplemental Information for [Part III]. If you include any attachments a. Electronic Submission of SF 424, Budget Information—Non- or appendices not specifically requested Applications. Construction Programs (ED 524), and all in the application package, these items Applications for grants under the BIE necessary assurances and certifications. will be counted as part of your Program—CFDA number 84.153A must You must attach any narrative sections application narrative [Part III] for be submitted electronically using e- of your application as files in a .DOC purposes of the page limit requirement. Application, accessible through the (document), .RTF (rich text), or .PDF You must include your complete Department’s e-Grants Web site at: (Portable Document) format. If you response to the selection criteria in the http://e-grants.ed.gov. upload a file type other than the three application narrative. We will reject your application if you file types specified in this paragraph or We will reject your application if you submit it in paper format unless, as submit a password protected file, we exceed the page limit. described elsewhere in this section, you will not review that material. 3. Submission Dates and Times: qualify for one of the exceptions to the • Your electronic application must Applications Available: November 18, electronic submission requirement and comply with any page limit 2009. submit, no later than two weeks before requirements described in this notice. Deadline for Transmittal of the application deadline date, a written • Prior to submitting your electronic Applications: January 8, 2010. statement to the Department that you application, you may wish to print a Applications for grants under this qualify for one of these exceptions. copy of it for your records. • program must be submitted Further information regarding After you electronically submit electronically using the Electronic Grant calculation of the date that is two weeks your application, you will receive an Application System (e-Application) before the application deadline date is automatic acknowledgment that will accessible through the Department’s e- provided later in this section under include a PR/Award number (an Grants site. For information (including Exception to Electronic Submission identifying number unique to your dates and times) about how to submit Requirement. application). While completing your electronic • your application electronically, or in Within three working days after application, you will be entering data paper format by mail or hand delivery submitting your electronic application, online that will be saved into a if you qualify for an exception to the fax a signed copy of the SF 424 to the database. You may not e-mail an electronic submission requirement, Application Control Center after electronic copy of a grant application to please refer to Section IV. 7. Other following these steps: us. Submission Requirements of this notice. (1) Print SF 424 from e-Application. Please note the following: (2) The applicant’s Authorizing 4. Other Submission Requirements of • You must complete the electronic Representative must sign this form. this notice. We do not consider an submission of your grant application by (3) Place the PR/Award number in the application that does not comply with 4:30:00 p.m., Washington, DC time, on upper right hand corner of the hard- the deadline requirements. the application deadline date. E- copy signature page of the SF 424. Individuals with disabilities who Application will not accept an (4) Fax the signed SF 424 to the need an accommodation or auxiliary aid application for this program after Application Control Center at (202) in connection with the application 4:30:00 p.m., Washington, DC time, on 245–6272. process should contact the person listed the application deadline date. • We may request that you provide us under FOR FURTHER INFORMATION Therefore, we strongly recommend that original signatures on other forms at a CONTACT in section VII of this notice. If you do not wait until the application later date. the Department provides an deadline date to begin the application Application Deadline Date Extension accommodation or auxiliary aid to an process. in Case of e-Application Unavailability: individual with a disability in • The hours of operation of the e- If you are prevented from electronically connection with the application Grants Web site are 6:00 a.m. Monday submitting your application on the process, the individual’s application until 7:00 p.m. Wednesday; and 6:00 application deadline date because e- remains subject to all other a.m. Thursday until 8:00 p.m. Sunday, Application is unavailable, we will requirements and limitations in this Washington, DC time. Please note that, grant you an extension of one business notice. because of maintenance, the system is day to enable you to transmit your Deadline for Intergovernmental unavailable between 8:00 p.m. on application electronically, by mail, or by Review: March 9, 2010. Sundays and 6:00 a.m. on Mondays, and hand delivery. We will grant this 5. Intergovernmental Review: This between 7:00 p.m. on Wednesdays and extension if— program is subject to Executive Order 6:00 a.m. on Thursdays, Washington, (1) You are a registered user of e- 12372 and the regulations in 34 CFR DC time. Any modifications to these Application and you have initiated an part 79. Information about hours are posted on the e-Grants Web electronic application for this Intergovernmental Review of Federal site. competition; and Programs under Executive Order 12372 • You will not receive additional (2)(a) E-Application is unavailable for is in the application package for this point value because you submit your 60 minutes or more between the hours program. application in electronic format, nor of 8:30 a.m. and 3:30 p.m., Washington, 6. Funding Restrictions: We reference will we penalize you if you qualify for DC time, on the application deadline regulations outlining funding an exception to the electronic date; or restrictions in the Applicable submission requirement, as described (b) E-Application is unavailable for Regulations section of this notice. elsewhere in this section, and submit any period of time between 3:30 p.m. 7. Other Submission Requirements: your application in paper format. and 4:30:00 p.m., Washington, DC time, Applications for grants under this • You must submit all documents on the application deadline date. program must be submitted electronically, including all information We must acknowledge and confirm electronically unless you qualify for an you typically provide on the following these periods of unavailability before exception to this requirement in forms: The Application for Federal granting you an extension. To request
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this extension or to confirm our U.S. Department of Education, Application Control Center at (202) 245– acknowledgment of any system Application Control Center, 6288. unavailability, you may contact either Attention: (CFDA Number 84.153A), (1) the person listed elsewhere in this LBJ Basement Level 1, 400 Maryland V. Application Review Information notice under FOR FURTHER INFORMATION Avenue, SW., Washington, DC 20202– 1. Selection Criteria: The selection CONTACT (see VII. Agency Contact) or (2) 4260. criteria for this program are in 34 CFR the e-Grants help desk at 1–888–336– You must show proof of mailing 661.31 and are as follows: (a) Need for 8930. If e-Application is unavailable consisting of one of the following: the project (25 points); (b) plan of due to technical problems with the (1) A legibly dated U.S. Postal Service operation (20 points); (c) qualifications system and, therefore, the application postmark. of the key personnel (10 points); (d) deadline is extended, an e-mail will be (2) A legible mail receipt with the budget and cost effectiveness (15 sent to all registered users who have date of mailing stamped by the U.S. points); (e) evaluation plan (25 points); initiated an e-Application. Extensions Postal Service. and (f) adequacy of resources (5 points). referred to in this section apply only to (3) A dated shipping label, invoice, or 2. General: For FY 2010, applications the unavailability of e-Application. receipt from a commercial carrier. are randomly divided into groupings. Exception to Electronic Submission (4) Any other proof of mailing International business and outreach Requirement: You qualify for an acceptable to the Secretary of the U.S. experts, organized into panels of three, exception to the electronic submission Department of Education. will review each application. Each requirement, and may submit your If you mail your application through panel reviews, scores, and ranks its application in paper format, if you are the U.S. Postal Service, we do not applications separately from the unable to submit an application through accept either of the following as proof applications assigned to the other e-Application because— of mailing: panels. However, ultimately, all • You do not have access to the (1) A private metered postmark. applications, without being divided into Internet; or (2) A mail receipt that is not dated by groups, will be ranked from the highest • You do not have the capacity to the U.S. Postal Service. to the lowest score for funding upload large documents to e- If your application is postmarked after purposes. the application deadline date, we will Application; and VI. Award Administration Information • not consider your application. No later than two weeks before the 1. Award Notices: If your application application deadline date (14 calendar Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before is successful, we notify your U.S. days or, if the fourteenth calendar day Representative and U.S. Senators and before the application deadline date relying on this method, you should check with your local post office. send you a Grant Award Notification falls on a Federal holiday, the next (GAN). We may notify you informally, c. Submission of Paper Applications business day following the Federal also. holiday), you mail or fax a written by Hand Delivery. If your application is not evaluated or statement to the Department, explaining If you qualify for an exception to the not selected for funding, we notify you. which of the two grounds for an electronic submission requirement, you 2. Administrative and National Policy exception prevents you from using the (or a courier service) may deliver your Requirements: We identify Internet to submit your application. If paper application to the Department by administrative and national policy you mail your written statement to the hand. You must deliver the original and requirements in the application package Department, it must be postmarked no two copies of your application, by hand, and reference these and other later than two weeks before the on or before the application deadline requirements in the Applicable application deadline date. If you fax date, to the Department at the following Regulations section of this notice. your written statement to the address: We reference the regulations outlining Department, we must receive the faxed U.S. Department of Education, the terms and conditions of an award in statement no later than two weeks Application Control Center, the Applicable Regulations section of before the application deadline date. Attention: (CFDA Number 84.153A), this notice and include these and other Address and mail or fax your 550 12th Street, SW., Room 7041, specific conditions in the GAN. The statement to: Tanyelle Richardson, Potomac Center Plaza, Washington, GAN also incorporates your approved Business and International Education DC 20202–4260. application as part of your binding Program, U.S. Department of Education, The Application Control Center commitments under the grant. 1990 K Street, NW., room 6017, accepts hand deliveries daily between 3. Reporting: At the end of your Washington, DC 20006–8521. FAX: 8:00 a.m. and 4:30:00 p.m., Washington, project period, you must submit a final (202) 502–7860. DC time, except Saturdays, Sundays, performance report, including financial Your paper application must be and Federal holidays. information, as directed by the submitted in accordance with the mail Note for Mail or Hand Delivery of Paper Secretary. If you receive a multi-year or hand delivery instructions described Applications: If you mail or hand deliver award, you must submit an annual in this notice. your application to the Department— performance report that provides the b. Submission of Paper Applications (1) You must indicate on the envelope most current performance and financial by Mail. and—if not provided by the Department—in expenditure information as directed by If you qualify for an exception to the Item 11 of the SF 424 the CFDA number, the Secretary under 34 CFR 75.118. electronic submission requirement, you including suffix letter, if any, of the Grantees are required to use the may mail (through the U.S. Postal competition under which you are submitting electronic data instrument, International Service or a commercial carrier) your your application; and Resource Information System (IRIS), to (2) The Application Control Center will application to the Department. You mail to you a notification of receipt of your complete both the annual and final must mail the original and two copies grant application. If you do not receive this reports. The Secretary may also require of your application, on or before the grant notification within 15 business days more frequent performance reports application deadline date, to the from the application deadline date, you under 34 CFR 75.720(c). For specific Department at the following address: should call the U.S. Department of Education requirements on reporting, please go to:
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http://www.ed.gov/fund/grant/apply/ fedregister. To use PDF, you must have established program authorized by the appforms/appforms.html. Adobe Acrobat Reader, which is Energy Independence and Security Act 4. Performance Measures: The available free at this site. of 2007 (Pub. L. 110–140) and funded purpose of the BIE program is to provide Note: The official version of this document under the American Recovery and funds to institutions of higher education is the document published in the Federal Reinvestment Act (Pub. L. 111–5). The that enter into agreements with trade Register. Free Internet access to the official program provides grants to states, associations or businesses for one or edition of the Federal Register and the Code territories, local governments and both of the following purposes: to of Federal Regulations is available on GPO Native American tribal governments to improve the academic teaching of the Access at: http://www.gpoaccess.gov/nara/ fund programs that reduce energy use business curriculum at institutions of index.html. and fossil fuel emissions and increase higher education and to conduct Delegation of Authority: The Secretary energy efficiency. The information outreach activities that expand the of Education has delegated authority to collected will be used to track the capacity of the business community to Daniel T. Madzelan, Director, recipients’ activities, their progress in engage in international economic Forecasting and Policy Analysis for the achieving program objectives, and funds activities. Office of Postsecondary Education, to expended (including expenditure rates). The Department will use the perform the functions and duties of the The information will also enable DOE to following BIE measures to evaluate its Assistant Secretary for Postsecondary provide timely information on program success in meeting this objective: Education. activities and accomplishments to OMB, Performance Measure 1: The number Congress and the public. The of outreach activities that are adopted or Dated: November 12, 2009. President’s pledge of transparency and disseminated by grantees within a year, Daniel T. Madzelan, accountability in the expenditure of divided by the total number of BIE Director, Forecasting and Policy Analysis. ARRA funds makes this information outreach activities conducted in the [FR Doc. E9–27686 Filed 11–17–09; 8:45 am] especially important. current reporting period. BILLING CODE 4000–01–P This information collection request Performance Measure 2: Percentage of contains: (1) OMB No. ‘‘New’’; (2) BIE projects judged to be successful by Information Collection Request Title: the program officer, based on a review DEPARTMENT OF ENERGY ‘‘Energy Efficiency and Conservation of information provided in annual Block Grant (EECBG) Program Status performance reports. Proposed Agency Information Report;’’ (3) Type of Review: Regular Efficiency Measure: Cost per high- Collection; Comment Request; Energy Submission; (4) Purpose: To collect quality, successfully completed BIE Efficiency Conservation Block Grant information on the status of grantee project. Program activities, expenditures, and results, to The Department will use information ensure that program funds are being AGENCY: provided by grantees in their U.S. Department of Energy. used appropriately, effectively, and performance reports submitted via IRIS ACTION: Notice. expeditiously; (5) Annual Estimated as the source of data for these measures. Number of Respondents: 2,357; (6) SUMMARY: The Department of Energy Reporting screens for institutions can be Annual Estimated Number of Total (DOE) invites public comment on a viewed at: http://www.ieps-iris.org/iris/ Responses: 28,284; (7) Estimated Time proposed collection of information that pdfs/BIE.pdf. Required per Response: local DOE is developing for submission to the governments/tribal governments—2 VII. Agency Contact Office of Management and Budget hours; states/territories—3 hours; (8) For Further Information Contact: Ms. (OMB) pursuant to the Paperwork Annual Estimated Number of Burden Tanyelle Richardson, International Reduction Act of 1995. Hours: 85,524; and (9) Annual Education Programs Service, U.S. DATES: Comments regarding this Estimated Reporting and Recordkeeping Department of Education, 1990 K Street, proposed information collection must Cost Burden: $3,985. NW., room 6017, Washington, DC be received on or before January 19, Comments are invited on: (a) Whether 20006–8521. Telephone: (202) 502–7626 2010. If you anticipate difficulty in the proposed collection of information or by e-mail: submitting comments within that is necessary for the proper performance [email protected]. period, contact the person listed in of the functions of the agency, including If you use a TDD, call the FRS, toll ADDRESSES as soon as possible. Any whether the information shall have free, at 1–800–877–8339. extension of the comment period will be practical utility; (b) the accuracy of the applicable to all interested parties. agency’s estimate of the burden of the VIII. Other Information ADDRESSES: Written comments may be proposed collection of information, Accessible Format: Individuals with sent to Johanna Zetterberg, U.S. including the validity of the disabilities can obtain this document Department of Energy, EE–2K/Forrestal methodology and assumptions used; (c) and a copy of the application package in Building, 1000 Independence Ave., SW., ways to enhance the quality, utility, and an accessible format (e.g., braille, large Washington, DC 20585 or by fax at 202– clarity of the information to be print, audiotape, or computer diskette) 586–1233, or by e-mail at collected; and (d) ways to minimize the on request to the program contact [email protected]. burden of the collection of information person listed under FOR FURTHER on respondents, including through the FOR FURTHER INFORMATION CONTACT: INFORMATION CONTACT in section VII of use of automated collection techniques Requests for additional information or this notice. or other forms of information copies of the information collection Electronic Access to This Document: technology. You can view this document, as well as instrument and instructions should be Comments submitted in response to all other documents of this Department directed to Jody Barringer at this notice will be summarized and/or published in the Federal Register, in [email protected]. included in the request for OMB text or Adobe Portable Document SUPPLEMENTARY INFORMATION: The approval of this information collection; Format (PDF) on the Internet at the Energy Efficiency and Conservation they also will become a matter of public following site: http://www.ed.gov/news/ Block Grant program is a newly record.
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Authority: Title V, Subtitle E of the Energy No. EA–275–A and has requested a ten- DEPARTMENT OF ENERGY Independence and Security Act (EISA), year term. Public Law 110–140. [OE Docket Nos. EA–247–C and 248–C] The electric energy which NorthPoint Issued in Washington, DC, on November 5, proposes to export to Canada would be 2009. Application To Export Electric Energy; surplus energy purchased from electric Cathy Zoi, Constellation NewEnergy, Inc. utilities, Federal power marketing Assistant Secretary, Energy Efficiency and agencies and other entities within the AGENCY: Office of Electricity Delivery Renewable Energy. United States. Each of the international and Energy Reliability, DOE. [FR Doc. E9–27597 Filed 11–17–09; 8:45 am] transmission facilities to be utilized by ACTION: Notice of Application. BILLING CODE 6450–01–P NorthPoint has previously been SUMMARY: Under two separate authorized by a Presidential permit applications, Constellation NewEnergy, issued pursuant to Executive Order DEPARTMENT OF ENERGY Inc. (Constellation) has applied for 10485, as amended, and are appropriate authority to transmit electric energy [OE Docket No. EA–275–B] for open access transmission by third from the United States to Mexico and parties. from the United States to Canada Application To Export Electric Energy; Procedural Matters: Any person pursuant to section 202(e) of the Federal NorthPoint Energy Solutions Inc. desiring to become a party to these Power Act. AGENCY: Office of Electricity Delivery proceedings or to be heard by filing DATES: Comments, protests, or requests and Energy Reliability, DOE. comments or protests to this application to intervene must be submitted on or ACTION: Notice of Application. should file a petition to intervene, before December 18, 2009. comment, or protest at the address ADDRESSES: Comments, protests, or SUMMARY: NorthPoint Energy Solutions provided above in accordance with requests to intervene should be Inc. (NorthPoint) has applied to renew §§ 385.211 or 385.214 of the Federal addressed as follows: Office of its authority to transmit electric energy Energy Regulatory Commission’s Rules Electricity Delivery and Energy from the United States to Canada of Practice and Procedures (18 CFR Reliability, Mail Code: OE–20, U.S. pursuant to section 202(e) of the Federal 385.211, 385.214). Fifteen copies of each Department of Energy, 1000 Power Act. petition and protest should be filed with Independence Avenue, SW., DATES: Comments, protests, or requests DOE on or before the date listed above. Washington, DC 20585–0350 (FAX to intervene must be submitted on or Comments on the NorthPoint 202–586–8008). before December 18, 2009. application to export electric energy to FOR FURTHER INFORMATION CONTACT: ADDRESSES: Comments, protests or Canada should be clearly marked with Ellen Russell (Program Office) requests to intervene should be Docket No. EA–275–B. Additional 202–586–9624 or Michael Skinker addressed as follows: Office of copies are to be filed directly with (Program Attorney) 202–586–2793. Electricity Delivery and Energy Douglas F. John and Elizabeth A. SUPPLEMENTARY INFORMATION: Exports of Reliability, Mail Code: OE–20, U.S. Zembruski, John & Hengerer, 1730 electricity from the United States to a Department of Energy, 1000 Rhode Island Ave., NW., Suite 600, foreign country are regulated by the Independence Avenue, SW., Washington, DC, 20036 and General Department of Energy (DOE) pursuant to Washington, DC 20585–0350 (FAX 202– Counsel of SaskPower—Law, Land and sections 301(b) and 402(f) of the 586–8008). Regulatory Affairs, 2025 Victoria Ave., Department of Energy Organization Act FOR FURTHER INFORMATION CONTACT: Regina, Saskatchewan, Canada S4P 0S1. (42 U.S.C. 7151(b), 7172(f)) and require Ellen Russell (Program Office) 202–586– A final decision will be made on this authorization under section 202(e) of 9624 or Michael Skinker (Program application after the environmental the FPA (16 U.S.C. 824a(e)). Attorney) 202–586–2793. impacts have been evaluated pursuant On November 13, 2001, DOE issued SUPPLEMENTARY INFORMATION: Exports of to the National Environmental Policy Order No. EA–247 authorizing electricity from the United States to a Act of 1969, and a determination is Constellation to transmit electric energy foreign country are regulated by the made by DOE that the proposed action from the United States to Mexico as a Department of Energy (DOE) pursuant to power marketer for a two year period. will not adversely impact on the sections 301(b) and 402(f) of the DOE has twice renewed Constellation’s reliability of the U.S. electric power Department of Energy Organization Act authority to export. The most recent supply system. (42 U.S.C. 7151(b), 7172(f)) and require authorization, in Order No. EA–247–B, authorization under section 202(e) of Copies of this application will be will expire on April 8, 2010. On October the FPA (16 U.S.C.824a(e)). made available, upon request, for public 27, 2009, Constellation applied to DOE On April 8, 2003, DOE issued Order inspection and copying at the address to renew the authorization contained in No. EA–275 authorizing NorthPoint to provided above, by accessing the Order No. EA–247–B for an additional transmit electric energy from the United program Web site at http://www.oe. five-year term. States to Canada as a power marketer energy.gov/permits_pending.htm, or by On November 26, 2001, DOE issued using existing international electric e-mailing Odessa Hopkins at Order No. EA–248 which authorized transmission facilities for two years. On [email protected]. Constellation to transmit electric energy December 10, 2004, DOE issued Order from the United States to Canada as a Issued in Washington, DC, on November No. EA–275–A, which renewed power marketer. That Order was also 12, 2009. NorthPoint’s authority for a five-year twice-renewed and will expire on April period, effective April 8, 2005. That Anthony J. Como, 8, 2010. On October 27, 2009, authorization will expire on April 8, Director, Permitting and Siting, Office of Constellation applied to DOE to renew 2010. On November 2, 2009, NorthPoint Electricity Delivery and Energy Reliability. the authorization contained in Order filed an application with DOE to renew [FR Doc. E9–27656 Filed 11–17–09; 8:45 am] No. EA–247–B for an additional five- the export authority contained in Order BILLING CODE 6450–01–P year term.
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The electric energy which ENVIRONMENTAL PROTECTION • Delivery: OPP Regulatory Public Constellation proposes to export to AGENCY Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Mexico and Canada would be surplus [EPA–HQ–OPP–2009–0851; FRL–8800–1] energy purchased from electric utilities, Potomac Yard (South Bldg.), 2777 S. Federal power marketing agencies and FIFRA Scientific Advisory Panel; Crystal Dr., Arlington, VA. Deliveries other entities within the United States. Notice of Public Meeting are only accepted during the Docket Each of the international transmission Facility ’s normal hours of operation AGENCY: Environmental Protection facilities to be utilized by Constellation (8:30 a.m. to 4 p.m., Monday through Agency (EPA). has previously been authorized by a Friday, excluding legal holidays). ACTION: Special arrangements should be made Presidential permit issued pursuant to Notice. for deliveries of boxed information. The Executive Order 10485, as amended, SUMMARY: There will be a 4–day meeting Docket Facility telephone number is and are appropriate for open access of the Federal Insecticide, Fungicide, (703) 305–5805. transmission by third parties. and Rodenticide Act Scientific Advisory Instructions: Direct your comments to Procedural Matters: Any person Panel (FIFRA SAP) to consider and docket ID number EPA–HQ–OPP–2009– desiring to become a party to these review Draft Framework and Case 0851. If your comments contain any proceedings or to be heard by filing Studies on Atrazine, Human Incidents, information that you consider to be CBI comments or protests to this application and the Agricultural Health Study: or otherwise protected, please contact Incorporation of Epidemiology and should file a petition to intervene, the DFO listed under FOR FURTHER Human Incident Data into Human comment, or protest at the address INFORMATION CONTACT to obtain special Health Risk Assessment. provided above in accordance with instructions before submitting your DATES: The meeting will be held on §§ 385.211 or 385.214 of the Federal comments. EPA’s policy is that all February 2 – 5, 2010, from Energy Regulatory Commission’s Rules comments received will be included in approximately 8:30 a.m. to 5 p.m. the docket without change and may be of Practice and Procedures (18 CFR Comments. The Agency encourages made available on-line at http:// 385.211, 385.214). Fifteen copies of each that written comments be submitted by www.regulations.gov, including any petition and protest should be filed with January 19, 2010 and requests for oral personal information provided, unless DOE on or before the date listed above. comments be submitted by January 26, the comment includes information Comments on the Constellation 2010. However, written comments and claimed to be Confidential Business application to export electric energy to requests to make oral comments may be Information (CBI) or other information Mexico should be clearly marked with submitted until the date of the meeting, whose disclosure is restricted by statute. Docket No. EA–247–C. Comments on but anyone submitting written Do not submit information that you the Constellation application to export comments after January 19, 2010 should consider to be CBI or otherwise electric energy to Canada should be contact the Designated Federal Official protected through regulations.gov or e- clearly marked with Docket No. (DFO) listed under FOR FURTHER mail. The regulations.gov website is an EA–248–C. Additional copies are to be INFORMATION CONTACT. For additional ‘‘anonymous access’’ system, which filed directly with Joseph Donovan, instructions, see Unit I.C. of the means EPA will not know your identity SUPPLEMENTARY INFORMATION. Senior Counsel, Constellation Energy or contact information unless you Nominations. Nominations of provide it in the body of your comment. Resources, LLC on behalf of candidates to serve as ad hoc members If you send an e-mail comment directly Constellation NewEnergy, Inc., 111 of FIFRA SAP for this meeting should to EPA without going through Market Place, Suite 500, Baltimore, MD be provided on or before November 30, regulations.gov, your e-mail address 21202. A final decision will be made on 2009. will be automatically captured and this application after the environmental Special accommodations. For included as part of the comment that is impacts have been evaluated pursuant information on access or services for placed in the docket and made available to the National Environmental Policy individuals with disabilities, and to on the Internet. If you submit an Act of 1969, and a determination is request accommodation of a disability, electronic comment, EPA recommends made by DOE that the proposed action please contact the DFO listed under FOR that you include your name and other will not adversely impact on the FURTHER INFORMATION CONTACT at least contact information in the body of your reliability of the U.S. electric power 10 days prior to the meeting to give EPA comment and with any disk or CD-ROM supply system. as much time as possible to process you submit. If EPA cannot read your Copies of these applications will be your request. comment due to technical difficulties made available, upon request, for public ADDRESSES: The meeting will be held at and cannot contact you for clarification, inspection and copying at the address the Environmental Protection Agency, EPA may not be able to consider your comment. Electronic files should avoid provided above, by accessing the Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. the use of special characters, any form program Web site at http:// Crystal Dr., Arlington, VA 22202. of encryption, and be free of any defects www.oe.energy.gov/ _ Comments. Submit your comments, or viruses. permits pending.htm, or by e-mailing identified by docket identification (ID) Docket: All documents in the docket Odessa Hopkins at number EPA–HQ–OPP–2009–0851, by are listed in the docket index available [email protected]. one of the following methods: at http://www.regulations.gov. Although Issued in Washington, DC, on November • Federal eRulemaking Portal: http:// listed in the index, some information is 12, 2009. www.regulations.gov. Follow the on-line not publicly available, e.g., CBI or other Anthony J. Como, instructions for submitting comments. information whose disclosure is • Mail: Office of Pesticide Programs restricted by statute. Certain other Director, Permitting and Siting, Office of (OPP) Regulatory Public Docket (7502P), material, such as copyrighted material, Electricity Delivery and Energy Reliability. Environmental Protection Agency, 1200 is not placed on the Internet and will be [FR Doc. E9–27655 Filed 11–17–09; 8:45 am] Pennsylvania Ave., NW., Washington, publicly available only in hard copy BILLING CODE 6450–01–P DC 20460–0001. form. Publicly available docket
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materials are available either in the 4. Describe any assumptions and 3. Seating at the meeting. Seating at electronic docket at http:// provide any technical information and/ the meeting will be open and on a first- www.regulations.gov, or, if only or data that you used. come basis. available in hard copy, at the OPP 5. If you estimate potential costs or 4. Request for nominations to serve as Regulatory Public Docket in Rm. S– burdens, explain how you arrived at ad hoc members of FIFRA SAP for this 4400, One Potomac Yard (South Bldg.), your estimate in sufficient detail to meeting. As part of a broader process for 2777 S. Crystal Dr., Arlington, VA. The allow for it to be reproduced. developing a pool of candidates for each hours of operation of this Docket 6. Provide specific examples to meeting, FIFRA SAP staff routinely Facility are from 8:30 a.m. to 4 p.m., illustrate your concerns and suggest solicits the stakeholder community for Monday through Friday, excluding legal alternatives. nominations of prospective candidates holidays. The Docket Facility telephone 7. Explain your views as clearly as for service as ad hoc members of FIFRA number is (703) 305–5805. possible, avoiding the use of profanity SAP. Any interested person or or personal threats. organization may nominate qualified Nominations, requests to present oral 8. Make sure to submit your comments, and requests for special individuals to be considered as comments by the comment period prospective candidates for a specific accommodations. Submit nominations deadline identified. to serve as ad hoc members of FIFRA meeting. Individuals nominated for this SAP, requests for special seating C. How May I Participate in this meeting should have expertise in one or accommodations, or requests to present Meeting? more of the following areas: Risk oral comments to the DFO listed under Assessment; Human Epidemiology You may participate in this meeting (particularly occupational and FOR FURTHER INFORMATION CONTACT. by following the instructions in this environmental epidemiology); Mode of FOR FURTHER INFORMATION CONTACT: unit. To ensure proper receipt by EPA, Action Analysis (particularly those with Myrta R. Christian, DFO, Office of it is imperative that you identify docket MOA framework experience); Human Science Coordination and Policy ID number EPA–HQ–OPP–2009–0851 in Relevance Framework; (7201M), Environmental Protection the subject line on the first page of your Pharmacokinetics (particularly animal Agency, 1200 Pennsylvania Ave., NW., request. to human extrapolation); Exposure Washington, DC 20460–0001; telephone 1. Written comments. The Agency Assessment of Pesticides (both number: (202) 564–8498; fax number: encourages that written comments be residential & agricultural worker). (202) 564–8382; e-mail address: submitted, using the instructions in Nominees should be scientists who have [email protected]. ADDRESSES, no later than January 19, sufficient professional qualifications, 2010, to provide FIFRA SAP the time including training and experience, to be SUPPLEMENTARY INFORMATION: necessary to consider and review the capable of providing expert comments I. General Information written comments. Written comments on the scientific issues for this meeting. are accepted until the date of the Nominees should be identified by name, A. Does this Action Apply to Me? meeting, but anyone submitting written occupation, position, address, and This action is directed to the public comments after January 19, 2010 should telephone number. Nominations should in general. This action may, however, be contact the DFO listed under FOR be provided to the DFO listed under FOR of interest to persons who are or may be FURTHER INFORMATION CONTACT. Anyone FURTHER INFORMATION CONTACT on or required to conduct testing of chemical submitting written comments at the before November 30, 2009. The Agency substances under the Federal Food, meeting should bring 30 copies for will consider all nominations of Drug, and Cosmetic Act (FFDCA), distribution to FIFRA SAP. prospective candidates for this meeting 2. Oral comments. The Agency FIFRA, and the Food Quality Protection that are received on or before this date. encourages that each individual or Act of 1996 (FQPA). Since other entities However, final selection of ad hoc group wishing to make brief oral may also be interested, the Agency has members for this meeting is a comments to FIFRA SAP submit their not attempted to describe all the specific discretionary function of the Agency. request to the DFO listed under FOR entities that may be affected by this The selection of scientists to serve on FURTHER INFORMATION CONTACT no later action. If you have any questions FIFRA SAP is based on the function of than January 26, 2010, in order to be regarding the applicability of this action the panel and the expertise needed to included on the meeting agenda. to a particular entity, consult the DFO address the Agency’s charge to the Requests to present oral comments will listed under FOR FURTHER INFORMATION panel. No interested scientists shall be be accepted until the date of the meeting CONTACT. ineligible to serve by reason of their and, to the extent that time permits, the membership on any other advisory B. What Should I Consider as I Prepare Chair of FIFRA SAP may permit the committee to a Federal department or My Comments for EPA? presentation of oral comments at the agency or their employment by a meeting by interested persons who have When submitting comments, Federal department or agency except the not previously requested time. The remember to: EPA. Other factors considered during request should identify the name of the the selection process include 1. Identify the document by docket ID individual making the presentation, the availability of the potential panel number and other identifying organization (if any) the individual will member to fully participate in the information (subject heading, Federal represent, and any requirements for panel’s reviews, absence of any conflicts Register date and page number). audiovisual equipment (e.g., overhead of interest or appearance of lack of 2. Follow directions. The Agency may projector, 35mm projector, chalkboard). impartiality, independence with respect ask you to respond to specific questions Oral comments before FIFRA SAP are to the matters under review, and lack of or organize comments by referencing a limited to approximately 5 minutes bias. Although financial conflicts of Code of Federal Regulations (CFR) part unless prior arrangements have been interest, the appearance of lack of or section number. made. In addition, each speaker should impartiality, lack of independence, and 3. Explain why you agree or disagree; bring 30 copies of his or her comments bias may result in disqualification, the suggest alternatives and substitute and presentation slides for distribution absence of such concerns does not language for your requested changes. to the FIFRA SAP at the meeting. assure that a candidate will be selected
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to serve on FIFRA SAP. Numerous consisting of seven members who are Research and Development (ORD), will qualified candidates are identified for appointed by the EPA Administrator solicit comment on the strengths and each panel. Therefore, selection from nominees provided by the National weaknesses of these types of decisions involve carefully weighing a Institutes of Health and the National epidemiology studies in addition to number of factors including the Science Foundation. FIFRA, as advice on the appropriate way to use candidates’ areas of expertise and amended by FQPA, established a such studies in the atrazine human professional qualifications and Science Review Board consisting of at health risk assessment. This case study achieving an overall balance of different least 60 scientists who are available to is also the first step in EPA’s atrazine scientific perspectives on the panel. In the SAP on an ad hoc basis to assist in science re-evaluation plan as described order to have the collective breadth of reviews conducted by the SAP. As a to the November 3, 2009 FIFRA SAP experience needed to address the peer review mechanism, FIFRA SAP previously (http://www.epa.gov/scipoly/ Agency’s charge for this meeting, the provides comments, evaluations and sap/meetings/2009/ Agency anticipates selecting recommendations to improve the 110309meeting.html). approximately 10 ad hoc scientists. effectiveness and quality of analyses A case study is also included to FIFRA SAP members are subject to made by Agency scientists. Members of illustrate an analysis of reported human the provisions of 5 CFR part 2634, FIFRA SAP are scientists who have incident cases using diazinon; a Executive Branch Financial Disclosure, sufficient professional qualifications, pesticide that has historically been used as supplemented by the EPA in 5 CFR including training and experience, to in residential settings. part 6401. In anticipation of this provide expert advice and Additionally, a case study concerning requirement, prospective candidates for recommendation to the Agency. the collaborative work by scientists from OPP, ORD, and the National Cancer service on the FIFRA SAP will be asked B. Public Meeting to submit confidential financial Institute (NCI) and the National Institute information which shall fully disclose, Data from epidemiology studies and of Environmental Health Sciences among other financial interests, the human incident reports contain (NIEHS) on the Agricultural Health candidate’s employment, stocks and valuable information about human Study (AHS) will be presented to: bonds, and where applicable, sources of exposure and response to pesticides. Compare the exposure algorithms used research support. The EPA will evaluate This information can contribute to a by OPP and the AHS, and; consider the candidates financial disclosure form weight of evidence analysis in the temporal relationships for multi- to assess whether there are financial characterization of human health risks. chemical exposure in the AHS. The conflicts of interest, appearance of a Epidemiology and incident data do, purpose of on-going work to compare lack of impartiality or any prior however, pose challenges with respect the OPP and AHS exposure algorithms involvement with the development of to characterizing human health risks. is to better understand differences and the documents under consideration EPA is convening a meeting of the similarities in the two approaches to (including previous scientific peer FIFRA Scientific Advisory Panel (SAP) estimating worker exposure. Evaluation review) before the candidate is to discuss science issues related to using of temporal relationships for multi- considered further for service on FIFRA epidemiology and human incident data chemical exposure in the AHS will in human health risk assessment. The SAP. Those who are selected from the involve information on the timing of Office of Pesticide Programs (OPP) will pool of prospective candidates will be uses and combined uses of pesticides, solicit comment on a draft framework asked to attend the public meetings and with particular emphasis on pesticides for implementing such data into human to participate in the discussion of key which share the same mode of action. health risk assessment in addition to issues and assumptions at these The Agency will solicit advice on types several case studies that illustrate meetings. In addition, they will be asked of evaluations conducted to date and scientific issues to be addressed at the to review and to help finalize the those being proposed with the third case SAP meeting. OPP’s draft framework meeting minutes. The list of FIFRA SAP study. describes a weight of the evidence The FIFRA SAP’s advice will provide members participating at this meeting evaluation that uses the best available the Agency with input on approaches to will be posted on the FIFRA SAP science on mode of action, exposure, integrate diverse types of experimental website at http://epa.gov/scipoly/sap or pharmacokinetics, animal and human toxicology and epidemiology data. The may be obtained from the OPP data from both in vivo and in vitro SAP input will be considered in Regulatory Public Docket at http:// studies in addition to models such as characterizing atrazine’s human health www.regulations.gov. physiologically-based pharmacokinetic risks which will be presented to the II. Background models when available. Three case SAP in September 2010. studies to be evaluated by the SAP are A. Purpose of FIFRA SAP intended to illustrate the draft C. FIFRA SAP Documents and Meeting FIFRA SAP serves as the primary framework and to highlight key science Minutes scientific peer review mechanism of challenges with incorporating EPA’s background paper, related EPA’s Office of Prevention, Pesticides epidemiology or human incident data supporting materials, charge/questions and Toxic Substances (OPPTS) and is into a risk assessment. The Agency will to FIFRA SAP, FIFRA SAP composition structured to provide scientific advice, solicit comment on the weight of the (i.e., members and ad hoc members for information and recommendations to evidence approach for evaluating and this meeting), and the meeting agenda the EPA Administrator on pesticides integrating the exposure, laboratory will be available by early January. In and pesticide-related issues as to the animal, and human information. addition, the Agency may provide impact of regulatory actions on health A case study on the evaluation of additional background documents as the and the environment. FIFRA SAP is a several epidemiology studies materials become available. You may Federal advisory committee established concerning atrazine will be presented. obtain electronic copies of these in 1975 under FIFRA that operates in These epidemiology studies are either documents, and certain other related accordance with requirements of the ecologic or retrospective cohort studies documents that might be available Federal Advisory Committee Act. FIFRA in design. OPP, in collaboration with electronically, at http:// SAP is composed of a permanent panel EPA’s Office of Water and Office of www.regulations.gov and the FIFRA
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SAP homepage at http://www.epa.gov/ Docket Facility telephone number is Pennsylvania Ave., NW., Washington, scipoly/sap. (703) 305–5805. DC 20460–0001; telephone number: FIFRA SAP will prepare meeting Instructions: Direct your comments to (703) 305–9096; e-mail address: minutes summarizing its docket ID number EPA–HQ–OPP–2009– [email protected]. recommendations to the Agency 0184. EPA’s policy is that all comments SUPPLEMENTARY INFORMATION: approximately 90 days after the received will be included in the docket meeting. The meeting minutes will be without change and may be made I. General Information posted on the FIFRA SAP website or available on-line at http:// A. Does this Action Apply to Me? may be obtained from the OPP www.regulations.gov, including any Regulatory Public Docket at http:// personal information provided, unless You may be potentially affected by www.regulations.gov. the comment includes information this action if you are an agricultural producer, food manufacturer, or List of Subjects claimed to be Confidential Business Information (CBI) or other information pesticide manufacturer. Potentially Environmental protection, Pesticides whose disclosure is restricted by statute. affected entities may include, but are and pests. Do not submit information that you not limited to: • Crop production (NAICS code 111). Dated: November 10, 2009. consider to be CBI or otherwise • Animal production (NAICS code Frank Sanders, protected through regulations.gov or e- mail. The regulations.gov website is an 112). Director, Office of Science Coordination and • Food manufacturing (NAICS code Policy. ‘‘anonymous access’’ system, which means EPA will not know your identity 311). • Pesticide manufacturing (NAICS [FR Doc. E9–27671 Filed 11–17–09; 8:45 am] or contact information unless you code 32532). BILLING CODE 6560–50–S provide it in the body of your comment. This listing is not intended to be If you send an e-mail comment directly exhaustive, but rather provides a guide to EPA without going through ENVIRONMENTAL PROTECTION for readers regarding entities likely to be regulations.gov, your e-mail address AGENCY affected by this action. Other types of will be automatically captured and entities not listed in this unit could also [EPA–HQ–OPP–2009–0184; FRL–8795-5] included as part of the comment that is be affected. The North American placed in the docket and made available Industrial Classification System Pesticide Product; Registration on the Internet. If you submit an (NAICS) codes have been provided to Applications for a New Active electronic comment, EPA recommends assist you and others in determining Ingredient Flutriafol that you include your name and other whether this action might apply to contact information in the body of your AGENCY: Environmental Protection certain entities. If you have any comment and with any disk or CD-ROM Agency (EPA). questions regarding the applicability of you submit. If EPA cannot read your ACTION: Notice. this action to a particular entity, consult comment due to technical difficulties the person listed under FOR FURTHER and cannot contact you for clarification, SUMMARY: This notice announces receipt INFORMATION CONTACT. of applications to register pesticide EPA may not be able to consider your products containing new active comment. Electronic files should avoid B. What Should I Consider as I Prepare ingredients not included in any the use of special characters, any form My Comments for EPA? currently registered products pursuant of encryption, and be free of any defects 1. Submitting CBI. Do not submit this to the provisions of section 3(c)(4) of the or viruses. information to EPA through Federal Insecticide, Fungicide, and Docket: All documents in the docket regulations.gov or e-mail. Clearly mark Rodenticide Act (FIFRA), as amended. are listed in the docket index available the part or all of the information that DATES: Comments must be received on at http://www.regulations.gov. Although you claim to be CBI. For CBI or before December 18, 2009. listed in the index, some information is information in a disk or CD-ROM that ADDRESSES: Submit your comments, not publicly available, e.g., CBI or other you mail to EPA, mark the outside of the identified by docket identification (ID) information whose disclosure is disk or CD-ROM as CBI and then number EPA–HQ–OPP–2009–0184, by restricted by statute. Certain other identify electronically within the disk or one of the following methods: material, such as copyrighted material, CD-ROM the specific information that is • Federal eRulemaking Portal: http:// is not placed on the Internet and will be claimed as CBI. In addition to one www.regulations.gov. Follow the on-line publicly available only in hard copy complete version of the comment that instructions for submitting comments. form. Publicly available docket includes information claimed as CBI, a • Mail: Office of Pesticide Programs materials are available either in the copy of the comment that does not (OPP) Regulatory Public Docket (7502P), electronic docket at http:// contain the information claimed as CBI Environmental Protection Agency, 1200 www.regulations.gov, or, if only must be submitted for inclusion in the Pennsylvania Ave., NW., Washington, available in hard copy, at the OPP public docket. Information so marked DC 20460–0001. Regulatory Public Docket in Rm. S– will not be disclosed except in • Delivery: OPP Regulatory Public 4400, One Potomac Yard (South Bldg.), accordance with procedures set forth in Docket (7502P), Environmental 2777 S. Crystal Dr., Arlington, VA. The 40 CFR part 2. Protection Agency, Rm. S–4400, One hours of operation of this Docket 2. Tips for preparing your comments. Potomac Yard (South Bldg.), 2777 S. Facility are from 8:30 a.m. to 4 p.m., When submitting comments, remember Crystal Dr., Arlington, VA. Deliveries Monday through Friday, excluding legal to: are only accepted during the Docket holidays. The Docket Facility telephone i. Identify the document by docket ID Facility’s normal hours of operation number is (703) 305–5805. number and other identifying (8:30 a.m. to 4 p.m., Monday through FOR FURTHER INFORMATION CONTACT: information (subject heading, Federal Friday, excluding legal holidays). Tamue L. Gibson, Registration Division Register date and page number). Special arrangements should be made (7505P), Office of Pesticide Programs, ii. Follow directions. The Agency may for deliveries of boxed information. The Environmental Protection Agency, 1200 ask you to respond to specific questions
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or organize comments by referencing a ENVIRONMENTAL PROTECTION Crystal Dr., Arlington, VA. The hours of Code of Federal Regulations (CFR) part AGENCY operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday or section number. [EPA–HQ–OPP–2006–0145; FRL–8799–3] iii. Explain why you agree or disagree; through Friday, excluding legal suggest alternatives and substitute Xylene; Addendum to the holidays. The Docket Facility telephone number is (703) 305–5805. language for your requested changes. Reregistration Eligibility Decision iv. Describe any assumptions and AGENCY: Environmental Protection II. Background provide any technical information and/ Agency (EPA). A. What Action is the Agency Taking? or data that you used. ACTION: Notice. Section 4 of the Federal Insecticide, v. If you estimate potential costs or SUMMARY: This notice announces EPA’s Fungicide, and Rodenticide Act (FIFRA) burdens, explain how you arrived at decision to modify certain provisions directs EPA to reevaluate existing your estimate in sufficient detail to and risk mitigation measures that were pesticides to ensure that they meet allow for it to be reproduced. specified in the 2005 Reregistration current scientific and regulatory vi. Provide specific examples to Eligibility Decision (RED) for the standards. In 2005, EPA issued a RED illustrate your concerns and suggest pesticide xylene, an aquatic herbicide for xylene under section 4(g)(2)(A) of alternatives. used in irrigation canals. EPA FIFRA. In response to a notice of availability published in the Federal vii. Explain your views as clearly as conducted this reassessment of the xylene RED in response to comments Register of May 22, 2006 (71 FR 14511) possible, avoiding the use of profanity received during the public comment (FRL–7766–3), the Agency received or personal threats. period. Based on new information substantive comments and information viii. Make sure to submit your received, and in a continuing effort to from commenters. The Agency’s comments by the comment period mitigate risk, the Agency has made response to comments is available for deadline identified. certain modifications to the xylene RED. viewing in the docket. The amended xylene RED reflects changes resulting FOR FURTHER INFORMATION CONTACT: II. Registration Applications from Agency consideration of the Tracy L. Perry, Pesticide Re-evaluation comments received on provisions of the EPA received applications as follows Division (7508P), Office of Pesticide RED, as well as efforts by the Agency to Programs, Environmental Protection to register pesticide products containing appropriately mitigate overall risk. The Agency, 1200 Pennsylvania Ave., NW., active ingredients not included in any addendum to the RED for xylene Washington, DC 20460–0001; telephone previously registered products pursuant concludes EPA’s reregistration number: (703) 308–0128; fax number: to the provision of section 3(c)(4) of eligibility decision-making process for (703) 308–7070; e-mail address: FIFRA. Notice of receipt of these this pesticide. [email protected]. applications does not imply a decision The xylene addendum includes: A by the Agency on the applications. SUPPLEMENTARY INFORMATION: summary of additional usage 1. File Symbol: 4787–LL. Applicant: I. General Information information provided by the Bureau of Cheminova A/S, c/o Cheminova, Inc., Reclamation and other stakeholders; a 1600 Wilson Blvd., Suite 700, Arlington, A. Does this Action Apply to Me? summary of the conclusions from VA 22209. Product name: Cheminova This action is directed to the public revised human health risk assessments; Flutriafol Technical. Active ingredient: in general, and may be of interest to a Agency reconsideration of the need for Flutriafol at 80%. Proposal wide range of stakeholders including removing the existing exemption from a tolerance; the addition of an ecological classification/Use: None. For the environmental, human health, farm data requirement; revised ecological manufacturing use formulation into worker and agricultural advocates; the mitigation measures; and an updated end-use products for foliar use on chemical industry; pesticide users; and members of the public interested in the Label Table, which summarizes specific soybeans to control soybean rust and on labeling language required on product apples to control scab and powdery sale, distribution, or use of pesticides. Since others also may be interested, the labels. Based on studies from the open mildew. Agency has not attempted to describe all literature and other information, the 2. File Symbol: 67760–TL. Applicant: the specific entities that may be affected Agency has determined that crops Cheminova A/S, c/o Cheminova, Inc. by this action. If you have any questions irrigated with xylene-treated water may Product name: Topguard Fungicide. regarding the applicability of this action bear finite residues of xylene, albeit, at Active ingredient: Flutriafol at 11.80%. to a particular entity, consult the person very low levels. Therefore, it is Proposal classification/Use: None. For listed under FOR FURTHER INFORMATION appropriate to retain the existing foliar use on soybeans to control CONTACT. tolerance exemption for xylene to soybean rust and on apples to control address any potential residues in food. B. How Can I Get Copies of this scab and powdery mildew. The Agency has determined, based on Document and Other Related additional usage information and List of Subjects Information? revised assessments, that use of xylene EPA has established a docket for this does not present dermal risks of concern Environmental protection, Pesticides action under docket identification (ID) for occupational workers. As the and pest. number EPA–HQ–OPP–2006–0145. potential for inhalation exposures to Dated: November 2, 2009. Publicly available docket materials are workers is uncertain at this time, given Lois Rossi, available either in the electronic docket the lack of data, the Agency is requiring Director, Registration Division, Office of at http://www.regulations.gov, or, if only additional personal protective Pesticide Programs. available in hard copy, at the Office of equipment (i.e., half-face respirator with Pesticide Programs (OPP) Regulatory an organic vapor-removing cartridge) for [FR Doc. E9–27307 Filed 11–17–09; 8:45 am] Public Docket in Rm. S–4400, One workers who apply or otherwise handle BILLING CODE 6560–50–S Potomac Yard (South Bldg.), 2777 S. xylene. In order to mitigate potential
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risks of concern for nontarget aquatic days of the date this notice appears in FOR FURTHER INFORMATION CONTACT: organisms, the Agency is requiring that the Federal Register. Judith B. Herman, OMD, 202–418–0214. treated canal water either be used to For additional information about the Jonathan J. Cordone, irrigate crops or be held for 96 hours information collection(s) send an e–mail prior to release into receiving water Senior Vice President and General Counsel. to [email protected] or contact Judith– bodies. In addition, as there are [FR Doc. E9–27627 Filed 11–17–09; 8:45 am] B.Herman, 202–418–0214. currently a limited number of aquatic BILLING CODE 6690–01–P SUPPLEMENTARY INFORMATION: herbicides registered for use in OMB Control No: 3060–XXXX. irrigation canals, the Agency has Title: Sections 1.49 and 1.54, determined that xylene may continue to FEDERAL COMMUNICATIONS Forbearance Petition Filing be used within all states identified COMMISSION Requirements. under the Bureau of Reclamation Act, Form No.: N/A. provided that the appropriate state Notice of Public Information Type of Review: New collection. registrations are also in place. Collection(s) Being Reviewed by the Respondents: Business or other for– profit. B. What is the Agency’s Authority for Federal Communications Commission, Comments Requested Number of Respondents: 10 Taking this Action? respondents; 10 responses. Section 4(g)(2) of FIFRA, as amended, November 13, 2009. Estimated Time Per Response: 640 directs that, after submission of all data SUMMARY: The Federal Communications hours. Frequency of Response: On occasion concerning a pesticide active ingredient, Commission, as part of its continuing reporting requirement, recordkeeping ‘‘the Administrator shall determine effort to reduce paperwork burden requirement and third party disclosure whether pesticides containing such invites the general public and other requirement. active ingredient are eligible for Federal agencies to take this Obligation to Respond: Required to reregistration,’’ before calling in product opportunity to comment on the obtain or retain benefits. Statutory specific data on individual end-use following information collection(s), as authority for this information collection products and either reregistering required by the Paperwork Reduction is contained in 47 U.S.C. Sections 151, products or taking other ‘‘appropriate Act of 1995, 44 U.S.C. 3501–3520. An 154(i), 154(j), 155(c), 160, 201 and regulatory action.’’ agency may not conduct or sponsor a collection of information unless it 303(r). List of Subjects displays a currently valid control Total Annual Burden: 6,400 hours. Total Annual Cost: N/A. Environmental protection, Pesticides number. No person shall be subject to any penalty for failing to comply with Privacy Act Impact Assessment: N/A. and pests, xylene. Nature and Extent of Confidentiality: a collection of information subject to the The Commission is not requesting that Dated: November 5, 2009. Paperwork Reduction Act (PRA) that the respondents submit confidential Richard P. Keigwin, Jr., does not display a valid control number. information to the Commission. Director, Pesticide Re-evaluation Division, Comments are requested concerning (a) Respondents may, however, request Office of Pesticide Programs. whether the proposed collection of confidential treatment for information [FR Doc. E9–27643 Filed 11–17–09; 8:45 am] information is necessary for the proper they believe to be confidential under 47 BILLING CODE 6560–50–S performance of the functions of the CFR 0.459 of the Commission’s rules. Commission, including whether the Need and Uses: The Commission is information shall have practical utility; requesting OMB approval of this new (b) the accuracy of the Commission’s information collection request in order EXPORT-IMPORT BANK OF THE burden estimate; (c) ways to enhance to obtain the full three year clearance UNITED STATES the quality, utility, and clarity of the from them. The Commission is information collected; and (d) ways to estimating 6,400 total annual burden Economic Impact Policy minimize the burden of the collection of hours. This notice is to inform the public information on the respondents, Under section 10 of the that the Export-Import Bank of the including the use of automated Communications Act of 1934, as United States has received an collection techniques or other forms of amended, telecommunications carriers application to guarantee approximately information technology. may petition the Commission to forbear $20 million in commercial bank DATES: Persons wishing to comments on from applying to a telecommunications financing for the export of this information collection should carrier any statutory provision or approximately $22 million of U.S. iron submit comments on January 19, 2010. Commission regulation. When a carrier ore mining equipment to Ukraine. The If you anticipate that you will be petitions the Commission for U.S. exports will enable the Ukrainian submitting comments, but find it forbearance, section 10 requires the company to produce approximately 10 difficult to do so within the period of Commission to make three million metric tons of iron ore pellets time allowed by this notice, you should determinations with regard to the need per year during the 7-year repayment advise the contact listed below as soon for the challenged provision or term of the loan. Available information as possible. regulation. If the Commission fails to act indicates that this new Ukrainian iron ADDRESSES: Direct all PRA comments to within one year (extended by three ore production will be consumed in the Nicholas A. Fraser, Office of additional months, if necessary) the Ukraine, Europe (Eastern, Western and Management and Budget (OMB), via fax petition is ‘‘deemed granted’’ by Central), China, and India. Interested at (202) 395–5167, or via the Internet at operation of law. These determinations parties may submit comments on this [email protected] and require complex, fact–intensive transaction by e-mail to to Judith B. Herman, Federal analysis, e.g., ‘‘whether forbearance [email protected] or by mail Communications Commission (FCC). To from enforcing the provision or to 811 Vermont Avenue, NW., Room submit your PRA comments by e–mail regulation will promote competitive 1238, Washington, DC 20571, within 14 send them to: [email protected]. market conditions.’’
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Under the new filing procedures, the or via e-mail to [email protected]. The accuracy compliance at the county- Commission requires that petitions for Commission’s contractor will receive level, the Bureau’s September 2008 forbearance must be ‘‘complete as filed’’ hand-delivered or messenger-delivered Public Notice seeking comment on these and explain in detail what must be paper filings for the Commission’s proposals, as well as the subsequent included in the forbearance petition. Secretary at 236 Massachusetts Avenue, voluntary commitments by Verizon The Commission also incorporates by NE., Suite 110, Washington, DC 20002. Wireless and Sprint Nextel to reference its rule, 47 CFR 1.49, which The filing hours at this location are 8 implement their proposed accuracy states the Commission’s standard a.m. to 7 p.m. All hand deliveries must standards in connection with separate ‘‘specifications as to pleadings and be held together with rubber bands or transactions approved by the documents.’’ Precise filing requirements fasteners. Any envelopes must be Commission in 2008. are necessary because of section 10’s disposed of before entering the building. We also seek to refresh the record strict time limit for Commission action. Commercial overnight mail (other than given that in response to the Bureau’s Also, commenters must be able to U.S. Postal Service Express Mail and September 2008 Public Notice, several understand clearly the scope of the Priority Mail) must be sent to 9300 East parties proposed alternative timeframes petition in order to comment on it. Hampton Drive, Capitol Heights, MD for implementation of revised location Finally, standard filing procedures 20743. U.S. Postal Service first-class, accuracy standards, and approximately inform petitioners precisely what the Express, and Priority mail should be a year has passed since some of those Commission expects from them in order addressed to 445 12th Street, SW., proposals were made. For example, in to make the statutory determinations Washington, DC 20554. In addition to addition to the timetables proposed by that the statute requires. filing comments with the Secretary, a APCO, NENA, Verizon Wireless, Sprint, copy of any comments on the and AT&T, T–Mobile and the Rural Federal Communications Commission. Cellular Association suggested that Marlene H. Dortch, Paperwork Reduction Act information collection requirements contained several of the benchmarks proposed by Secretary, Office of the Secretary, Office of AT&T should be extended by two years. Managing Director. herein should be submitted to the Federal Communications Commission We request that interested parties [FR Doc. E9–27723 Filed 11–17–09; 8:45 am] via e-mail to [email protected] and to refresh the record on these proposed BILLING CODE 6712–01–S Nicholas A. Fraser, Office of timeframes for implementation in light Management and Budget, via e-mail to of the passage of time and any other [email protected] or via relevant developments in the industry FEDERAL COMMUNICATIONS or economy. COMMISSION fax at 202–395–5167. FOR FURTHER INFORMATION CONTACT: Comment Filing Procedures [PS Docket No. 07–114; DA 09–2397] David Siehl, Public Safety and Interested parties may file comments Homeland Security Bureau, (202) 418– E911 Location Accuracy on the above-referenced petition on or 1313, [email protected]. For before November 20, 2009, and reply AGENCY: Federal Communications additional information concerning the comments may be filed on or before Commission. Paperwork Reduction Act information December 4, 2009. All comments should ACTION: Notice. collection requirements that this reference the appropriate petition(s) and document contains, send an e-mail to PS Docket No. 07–114. SUMMARY: In this document, the Federal [email protected] or contact Judith Boley All comments may be filed using: (1) Communications Commission seeks to Herman at (202) 418–0214. The Commission’s Electronic Comment refresh the record in the proceeding SUPPLEMENTARY INFORMATION: By this Filing System (ECFS), (2) the Federal regarding service rules for wireless Public Notice, DA 09–2397, released Government’s eRulemaking Portal, or (3) Enhanced 911 (E911) Phase II location November 6, 2009, the Public Safety and by filing paper copies. See Electronic accuracy and reliability. The Public Homeland Security Bureau (Bureau) Filing of Documents in Rulemaking Notice seeks comment on whether, seeks to refresh the record in the above- Proceedings, 63 FR 24121 (1998). since the most recent activity in the referenced docket addressing location • Electronic Filers: Statements in docket, subsequent developments in the accuracy standards for wireless E911 support of or in opposition to the industry and technology may have calls. In light of the passage of time Petition and replies to such statements affected parties’ positions on the issues since the most recent activity in this may be filed electronically using the raised. The intended effect of this docket, we seek comment on whether Internet by accessing the ECFS: http:// document is to provide an updated subsequent developments in the www.fcc.gov/cgb/ecfs or the Federal record for the Commission to fully industry and technology may have eRulemaking Portal: http:// consider what service rules concerning affected parties’ positions on the issues www.regulations.gov. Filers should location accuracy and reliability might raised. follow the instructions provided on the be adopted. Recent developments in this website for submitting comments. DATES: Comments are due November 20, proceeding include the vacatur and • For ECFS filers, in completing the 2009. Reply Comments are due remand of the Commission’s 2007 transmittal screen, filers should include December 4, 2009. Report and Order in this proceeding, the their full name, U.S. Postal Service ADDRESSES: All filings must be submission by the Association of Public mailing address, and the rulemaking addressed to: Marlene H. Dortch, Office Safety Communications Officials- number. Parties may also submit an of the Secretary, Federal International (APCO), the National electronic statement in support of or in Communications Commission, 445 12th Emergency Number Association opposition to the Petition and/or replies Street, SW., Washington, DC 20554. (NENA), Verizon Wireless, Sprint thereto by Internet e-mail. To get filing Parties must also serve one copy with Nextel Corporation, and AT&T of instructions, filers should send an e- the Commission’s copy contractor, Best written ex parte letters recommending mail to [email protected] and include the Copy and Printing, Inc. (BCPI), Portals new E911 accuracy requirements for following words in the body of the II, 445 12th Street, SW., Room CY–B402, both handset-based and network-based message: ‘‘get form.’’ A sample form and Washington, DC 20554, (202) 488–5300, technologies in order to achieve E911 directions will be sent in response.
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• Paper Filers: Parties who choose to These matters shall be treated as DATES: The Board made its file by paper must file an original and ‘‘permit-but-disclose’’ proceedings in determination on November 12, 2009. four copies of each filing. accordance with the Commission’s ex FOR FURTHER INFORMATION CONTACT: If parte rules. Persons making oral ex parte Filings can be sent by hand or you have questions regarding this presentations are reminded that messenger delivery, by commercial notice, contact Thomas P. Bolt, Counsel, memoranda summarizing such overnight courier, or by first-class or Legal Division, (703) 562–2046 or presentations must contain summaries overnight U.S. Postal Service mail [email protected]; Shane Kiernan, Senior of the substance of the presentations (although the Commission continues to Attorney, Legal Division, 703) 562–2632 experience delays in receiving U.S. and not merely a listing of the subjects discussed. More than a one- or two- or [email protected], FDIC, 3501 N. Postal Service mail). All filings must be Fairfax Drive, Arlington, VA 22226 addressed to: Marlene H. Dortch, Office sentence description of the views and of the Secretary, Federal arguments presented generally is SUPPLEMENTARY INFORMATION: On July Communications Commission, 445 12th required. Other requirements pertaining 11, 2008, IndyMac Bank, F.S.B., Street, SW., Washington, DC 20554. to oral and written presentations are set Pasadena, California (‘‘IndyMac Bank’’) Parties must also serve one copy with forth in section 1.1206(b) of the (FIN # 10007) was closed by the Office the Commission’s copy contractor, Best Commission’s rules. of Thrift Supervision and the Federal Copy and Printing, Inc. (BCPI), Portals This document contains proposed Deposit Insurance Corporation (‘‘FDIC’’) II, 445 12th Street, SW., Room CY–B402, new information collection was appointed as its receiver. In Washington, DC 20554, (202) 488–5300, requirements. The Commission, as part complying with its statutory duty to or via e-mail to [email protected]. of its continuing effort to reduce resolve the institution in the method • The Commission’s contractor will paperwork burdens, invites the general that is least costly to the deposit receive hand-delivered or messenger- public and the Office of Management insurance fund (see 12 U.S.C. delivered paper filings for the and Budget (OMB) to comment on the 1823(c)(4)), the FDIC effected a pass- Commission’s Secretary at 236 information collection requirements through receivership. Accordingly, the Massachusetts Avenue, NE., Suite 110, contained in this document as required FDIC organized IndyMac Federal Bank, Washington, DC 20002. The filing hours by the Paperwork Reduction Act of FSB, Pasadena, California (‘‘IndyMac at this location are 8 a.m. to 7 p.m. All 1995, Public Law 104–13. In addition, Federal’’), a new federal savings bank hand deliveries must be held together the Commission notes that pursuant to for which the FDIC was appointed as with rubber bands or fasteners. Any the Small Business Paperwork Relief conservator. IndyMac Bank’s assets envelopes must be disposed of before Act of 2002, Public Law 107–198, see 44 were transferred to IndyMac Federal entering the building. U.S.C. 3506(c)(4), we previously sought under an agreement whereby the specific comment on how the • Commercial overnight mail (other amount (if any) realized from the final Commission might ‘‘further reduce the than U.S. Postal Service Express Mail resolution of IndyMac Federal after information collection burden for small and Priority Mail) must be sent to 9300 payment in full of IndyMac Federal’s business concerns with fewer than 25 East Hampton Drive, Capitol Heights, obligations was to be paid to the employees.’’ MD 20743. IndyMac Bank receivership. On March • For further information regarding this 19, 2009, IndyMac Federal was placed U.S. Postal Service first-class, proceeding, contact David Siehl, Public Express, and Priority mail should be in receivership and substantially all of Safety and Homeland Security Bureau, its assets were sold. The amount addressed to 445 12th Street, SW., (202) 418–1313, [email protected]. Washington, DC 20554. realized from the resolution of IndyMac • People with Disabilities: To request Federal Communications Commission. Federal is insufficient to pay all of its materials in accessible formats for Thomas J. Beers, liabilities, and therefore there will be no people with disabilities (Braille, large Division Chief, Policy, Public Safety and amount to pay to the IndyMac Bank print, electronic files, audio format), Homeland Security Bureau. receivership. send an e-mail to [email protected] or call [FR Doc. E9–27666 Filed 11–17–09; 8:45 am] Section 11(d)(11)(A) of the FDI Act, the Consumer & Governmental Affairs BILLING CODE 6712–01–P 12 U.S.C. 1821(d)(11)(A), sets forth the Bureau at 202–418–0530 (voice), 202– order of priority for distribution of 418–0432 (tty). amounts realized from the liquidation or Documents submitted in PS Docket FEDERAL DEPOSIT INSURANCE other resolution of an insured No. 07–114, including each petition, CORPORATION depository institution to pay claims. will be accessible via the Commission’s Under the statutory order of priority, ECFS (at: http://www.fcc.gov/cgb/ecfs) Determination of Insufficient Assets To administrative expenses and deposit by listing 07–114 in the ‘‘Proceeding’’ Satisfy Claims Against Financial liabilities must be paid in full before search field. These documents also will Institution in Receivership any distribution may be made to general be available for public inspection and AGENCY: Federal Deposit Insurance unsecured creditors or any lower copying during business hours at the Corporation (FDIC). priority claims. The FDIC has FCC Reference Information Center, ACTION: Notice. determined that the assets of IndyMac Portals II, 445 12th St., SW., Room CY Bank are insufficient to make any A257, Washington, DC 20554. The SUMMARY: The FDIC, by its Board of distribution on general unsecured documents may also be purchased from Directors, has determined that claims and therefore, such claims, BCPI, telephone (202) 488–5300, insufficient assets exist in the asserted or unasserted, will recover facsimile (202) 488–5563, TTY (202) receivership of IndyMac Bank, F.S.B., nothing and have no value. The FDIC 488–5562, e-mail [email protected]. Pasadena, California and the has also determined that the assets of Document DA 09–2397 can also be receivership of IndyMac Federal Bank, IndyMac Federal are insufficient to downloaded in Word or Portable FSB, Pasadena, California to make any make any distribution on general Document Format (PDF) at: http:// distribution to general unsecured unsecured claims and therefore, such www.publicsafety.fcc.gov/pshs/releases/ claims, and therefore such claims will claims, asserted or unasserted, will index.htm. recover nothing and have no value. recover nothing and have no value.
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Dated at Washington, DC, this 12th day of SUPPLEMENTARY INFORMATION: You may By Order of the Federal Maritime November, 2009. call 202–452–3206 beginning at Commission. By Order of the FDIC Board of Directors. approximately 5 p.m. two business days Tanga S. FitzGibbon, Federal Deposit Insurance Corporation. before the meeting for a recorded Assistant Secretary. Valerie J. Best, announcement of bank and bank [FR Doc. E9–27647 Filed 11–17–09; 8:45 am] Assistant Executive Secretary. holding company applications BILLING CODE 6730–01–P [FR Doc. E9–27593 Filed 11–17–09; 8:45 am] scheduled for the meeting; or you may BILLING CODE 6714–01–P contact the Board’s Web site at http:// www.federalreserve.gov for an electronic FEDERAL MARITIME COMMISSION announcement that not only lists Ocean Transportation Intermediary FEDERAL ELECTION COMMISSION applications, but also indicates procedural and other information about License Applicants Sunshine Act Notices the meeting. Notice is hereby given that the Board of Governors of the Federal Reserve following applicants have filed with the AGENCY: Federal Election Commission. System, November 13, 2009. Federal Maritime Commission an DATE AND TIME: Tuesday, November 17, Robert deV. Frierson, application for license as a Non-Vessel- 2009, at 10 a.m. Deputy Secretary of the Board. Operating Common Carrier and Ocean PLACE: 999 E Street, NW., Washington, [FR Doc. E9–27695 Filed 11–16–09; 11:15 Freight Forwarder—Ocean DC. am] Transportation Intermediary pursuant to section 19 of the Shipping Act of 1984 STATUS: This meeting will be closed to BILLING CODE 6210–01–S as amended (46 U.S.C. Chapter 409 and the public. 46 CFR 515). ITEMS TO BE DISCUSSED: Persons knowing of any reason why Compliance matters pursuant to 2 FEDERAL MARITIME COMMISSION the following applicants should not U.S.C. 437g. receive a license are requested to Audits conducted pursuant to 2 Notice of Agreement Filed contact the Office of Transportation U.S.C. 437g, 438(b), and Title 26, U.S.C. Intermediaries, Federal Maritime Matters concerning participation in The Commission hereby gives notice Commission, Washington, DC 20573. civil actions or proceedings or of the filing of the following agreement arbitration. under the Shipping Act of 1984. Non-Vessel-Operating Common Carrier Internal personnel rules and Interested parties may submit comments Ocean Transportation Intermediary procedures or matters affecting a on the agreement to the Secretary, Applicants particular employee. Federal Maritime Commission, Ship Beyond, Inc., 263 E. Redondo PERSON TO CONTACT FOR INFORMATION: Washington, DC 20573, within ten days Beach Blvd., Gardena, CA 90245. Judith Ingram, Press Officer, Telephone: of the date this notice appears in the Officer: Jimmy Lee, President (202) 694–1220. Federal Register. Copies of the (Qualifying Individual) agreement are available through the Seafair International Logistics, LLC, 910 Mary W. Dove, Commission’s Web site (http:// W. Philips Street, #220, Ontario, CA Secretary of the Commission. www.fmc.gov) or by contacting the 91762. Officers: Hengyi (Kelvin) Gu, [FR Doc. E9–27549 Filed 11–17–09; 8:45 am] Office of Agreements at (202)-523–5793 Manager (Qualifying Individual), Tao BILLING CODE 6715–01–M or [email protected]. Lu, Member Agreement No.: 011223–044. Daudry Business Group, Corp., dba Title: Transpacific Stabilization Adam Logistics, 6713 NW 84th Ave., FEDERAL RESERVE SYSTEM Agreement. Miami, FL 33166. Officer: Darcy G. Parties: American President Lines, Perez, President (Qualifying Sunshine Act Meeting Ltd. and APL Co. PTE Ltd.; (operating Individual) Inter-American Movers and Forwarders, AGENCY HOLDING THE MEETING: Board of as a single carrier); China Shipping Container Lines (Hong Kong) Company LLC, 3032 N.W. 72nd Avenue, Miami, Governors of the Federal Reserve FL 33122. Officers: Terence A. System. Limited and China Shipping Container Lines Company Limited (operating as a Rignault, Director (Qualifying TIME AND DATE: 11:30 a.m., Monday, single carrier); CMA CGM, S.A.; COSCO Individual), Alejandro Jerez, November 23, 2009. Container Lines Company Ltd; Managing Member PLACE: Marriner S. Eccles Federal Evergreen Line Joint Service Agreement; Non-Vessel-Operating Common Carrier Reserve Board Building, 20th and C Hanjin Shipping Co., Ltd.; Hapag-Lloyd and Ocean Freight Forwarder Streets, N.W., Washington, D.C. 20551. AG; Hyundai Merchant Marine Co., Transportation Intermediary STATUS: Closed. Ltd.; Kawasaki Kisen Kaisha Ltd.; Applicants Mediterranean Shipping Company; MATTERS TO BE CONSIDERED: The Ultimate Freight Management & Nippon Yusen Kaisha; Orient Overseas 1. Personnel actions (appointments, Logistics, Inc., 9215 Hall Road, Container Line Limited; Yangming promotions, assignments, Downey, CA 90241. Officers: Charles Marine Transport Corp.; and Zim reassignments, and salary actions) Chen, President (Qualifying Integrated Shipping Services, Ltd. involving individual Federal Reserve Individual), Yi Li, CFO System employees. Filing Party: David F. Smith, Esq.; Royalty Logistics, Inc., 6356 NW 99 2. Any items carried forward from a Sher & Blackwell LLP; 1850 M Street, Ave., Miami, FL 33178. Officers: previously announced meeting. NW.; Suite 900; Washington, DC 20036. Doumit Shmouni, President FOR FURTHER INFORMATION CONTACT: Synopsis: The amendment adds A.P. (Qualifying Individual), Diane Michelle Smith, Director, or Dave Moller-Maersk A/S as a party to the Aboukhalil, Secretary Skidmore, Assistant to the Board, Office agreement. Prime Movers Inc., 242 South Coastal of Board Members at 202–452–2955. Dated: November 13, 2009. Highway 17, Midway, GA 31320.
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Officers: Olugbenga A. Awe, CEO International Cargo Freight Forwarder, Name: T.E.E. Transportation Services, (Qualifying Individual), Akinwole A. Inc., 105–20 Liberty Ave., Ozone Park, LLC. Awujo, Treasurer NY 11417. Officers: Edul Ahmad, Address: 4027 Joe Street, Charlotte, Power Freight Systems, Inc., 7447A CEO (Qualifying Individual), Steve NC 28206. Morton Ave., Newark, CA 94560. Massiah, Vice President Date Revoked: November 6, 2009. Officers: Sandra K. Thoroughman, World Express & Connection Inc, 63 Reason: Surrendered license Dir. Of Int’l Services (Qualifying Hook Road, Bayonne, NJ 07002. voluntarily. Individual), Malcom Winspear, Officers: Raya Bakhirev, General License Number: 020611NF. President Manager (Qualifying Individual), Name: Pro Cargo Solutions, Inc. Pangaea Logistics, Inc., 45–09 104th Aleksandr Solovyev, President Address: 2324 Pennsylvania Ave., Ste. Logistics Management Solutions, L.C., Street, Corona, NY 11368. Officers: #3, Lomita, CA 90717. One City Place, Suite 415, Saint Anthony C. Vozzolo, President Date Revoked: October 12, 2009. Louis, MO 63141. Officers: Gregory L. (Qualifying Individual), David S. Reason: Surrendered license Umstead, Company Officer Fine, Vice President voluntarily. K&K Global LLC, 6820 Ravens Crest (Qualifying Individual), Dennis F. Drive, Plainsboro, NJ 08536. Officer: Schoemehl, President License Number: 018275NF. Katsiaryna Dzemyaniuk, President PJC Express Inc., 16611 Living Rock Name: Global Fritz Logistics Service (Qualifying Individual) Court, Chino Hills, CA 91709. Co., Ltd. JBH Worldwide LLC dba JBH Officers: Ching C. Lei, Secretary Address: 15155 El Selinda Dr., Worldwide, 701 Tennent Road, (Qualifying Individual), Paul H. Tsui, Hacienda Heights, CA 91745. Manalapan, NJ 07726. Officer: Jay President Date Revoked: October 30, 2009. Reason: Surrendered license Horowitz, President (Qualifying Dated: November 13, 2009. voluntarily. Individual) Tanga S. FitzGibbon, JCC International Enterprises Inc., State Assistant Secretary. Sandra L. Kusumoto, Road #190 Km. 3.4 Sabana Abajo [FR Doc. E9–27648 Filed 11–17–09; 8:45 am] Director, Bureau of Certification and Ward, Carolina, PR 00984. Officer: Licensing. Liza Vilanova, President (Qualifying BILLING CODE 6730–01–P [FR Doc. E9–27650 Filed 11–17–09; 8:45 am] Individual) United Logistics Corp, 3650 Mansell BILLING CODE 6730–01–P FEDERAL MARITIME COMMISSION Rd., #400, Alpharetta, GA 30022. Officers: Wei Wen Li, Secretary Ocean Transportation Intermediary FEDERAL MARITIME COMMISSION (Qualifying Individual), Chuanxiang License Revocations Li, President Ocean Transportation Intermediary The Federal Maritime Commission License Reissuance Ocean Freight Forwarder—Ocean hereby gives notice that the following Transportation Intermediary Ocean Transportation Intermediary Notice is hereby given that the Applicants licenses have been revoked pursuant to following Ocean Transportation Mariela N. Lopez-Torres, 665 NW 85th section 19 of the Shipping Act of 1984 Intermediary license has been reissued Place, Apt. 103, Miami, FL 33126. (46 U.S.C. Chapter 409) and the by the Federal Maritime Commission Sole Proprietor regulations of the Commission pursuant to section 19 of the Shipping Blue Supply Chain Solutions, LLC, 4061 pertaining to the licensing of Ocean Act of 1984 (46 U.S.C. Chapter 409) and Windward Cove Lane, Apison, TN Transportation Intermediaries, 46 CFR the regulations of the Commission 37302. Officers: Corey P. Bonner, Part 515, effective on the corresponding pertaining to the licensing of Ocean Chief Manager (Qualifying date shown below: Transportation Intermediaries, 46 CFR Individual), Dana D. Reeves, Secretary License Number: 021721NF. Part 515.
License No. Name/address Date reissued
013253N ...... Total Service Line Corporation dba Total Shipping Line Corp., 12140 E. Artesia October 14, 2009. Blvd., #208, Artesia, CA 90701.
Sandra L. Kusumoto, Hart-Scott Rodino Antitrust period provided by law and the Director, Bureau of Certification and Improvements Act of 1976, requires premerger notification rules. The grants Licensing. persons contemplating certain mergers were made by the Federal Trade [FR Doc. E9–27649 Filed 11–17–09; 8:45 am] or acquisitions to give the Federal Trade Commission and the Assistant Attorney BILLING CODE 6730–01–P Commission and the Assistant Attorney General for the Antitrust Division of the General advance notice and to wait Department of Justice. Neither agency designated periods before intends to take any action with respect FEDERAL TRADE COMMISSION consummation of such plans. Section to these proposed acquisitions during 7A(b)(2) of the Act permits the agencies, the applicable waiting period. Granting of Request for Early in individual cases, to terminate this Termination of the Waiting Period waiting period prior to its expiration Under the Premerger Notification and requires that notice of this action be Rules published in the Federal Register. Section 7A of the Clayton Act, 15 The following transactions were U.S.C. 18a, as added by Title II of the granted early termination of the waiting
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ET Req ETDate Trans No. status Party name
Transaction Granted Early Termination
05–OCT–09 ...... 20090758 G Adobe Systems Incorporated. G Omniture, Inc. G Omniture, Inc. 07–OCT–09 ...... 20090780 G Aurora Equity Partners III, LP. G HLTH Corporation. G Porex Corporation. 20090786 G American Securities Partners V. L.P. G GenTek Inc. G GenTek Inc. 08–OCT–09 ...... 20090768 G AstraZeneca plc. G Nektar Therapeutics. G Nektar Therapeutics. 09–OCT–09 ...... 20090707 G Alamo Group Inc. G Henry Crown and Company. G Bush Hog, LLC. 20090764 G SAS Rue La Boetie. G Societe Generale. G The TCW Group, Inc. 20090794 G SteelRiver Infrastructure Fund North America LP. G Dominion Resources, Inc. G Hope Gas, Inc. G The Peoples Natural Gas Company. 20090796 G Comcast Corporation. G William A. Capraro, Jr. G CIMCO Communications, Inc. G Capraro Development, LLC. 20100002 G Institutional Venture Partners XII, L.P. G Twitter, Inc. G Twitter, Inc. 13–OCT–09 ...... 20090738 G Syniverse Holdings, Inc. G VeriSign, Inc. G VeriSign ICX Corporation. 20090739 G NYSE Euronext. G NYFIX, Inc. G NYFIX, Inc. 20090791 G J&F Participacoes S.A. G Lonnie A. ‘‘Bo’’ Pilgrim. G Pilgrim’s Pride Corporation. 20090795 G Adage Capital Partners, L.P. G AMAG Pharmaceuticals, Inc. G AMAG Pharmaceuticals, Inc. 14–OCT–09 ...... 20090325 G Pfizer Inc. G Wyeth. G Wyeth. 15–OCT–09 ...... 20090763 G Abbott Laboratories, Inc. G Visiogen Inc. G Visiogen Inc. 19–OCT–09 ...... 20100006 G Exterran Partners, LP. G Exterran Holdings, Inc. G Exterran Energy Solutions, L.P. 20100009 G Great Hill Equity Partners III, LP. G LECG Corporation. G LECG Corporation. 20100011 G Prospect Acquisition Corp. G William J. McMorrow. G Kennedy-Wilson, Inc. 20100012 G Blackstone Capital Partners (Cayman III) V L.P. G Jorge Paulo Lemann. G Busch Entertainment Corporation. 20100013 G Blackstone Capital Partners (Cayman III) V L.P. G Eugenie Path Sebastien EPS, SA. G Busch Entertainment Corporation. 20100020 G Sanofi-Aventis. G Fovea Pharmaceuticals, S.A. G Fovea Pharmaceuticals, S.A. 20100030 G Berkshire Fund VII, L.P. G GOBP Holdings, Inc. G GOBP Holdings, Inc. 21–OCT–09 ...... 20090767 G Raytheon Company. G BBN Technologies Holding Corp. G BBN Technologies Holding Corp.
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ET Req ETDate Trans No. status Party name
20090769 G Intuit Inc. G Mint Software Inc. G Mint Software Inc. 23–OCT–09 ...... 20100025 G Clayton, Dubilier & Rice Fund VIII, L.P. G Appointive Distributing Trust B u/a Samuel Johnson, 1988 T#1. G JohnsonDiversey Holdings, Inc. 20100036 G Emerson Electric Co. G Avocent Corporation. G Avocent Corporation. 26–OCT–09 ...... 20090788 G Oak Hill Capital Partners Ill, L.P. G ODN Holding Corporation. G ODN Holding Corporation. 20100022 G Macquarie Group Limited. G Fox-Pitt Kelton Cochran Caronia, Waller LLC G Fox-Pitt Kelton Cochran Caronia Waller LLC. 27–OCT–09 ...... 20100024 G GrainCorp Limited. G United Malt Holdings LP. G Malt U.K. Holdco Limited. G Malt Luxco S.a.r.l. G Malt U.S. Holdco, Inc. 20100037 G Iconix Brand Group, Inc. G Seth Gerszberg. G Yakira, L.L.C. 20100038 G Iconix Brand Group, Inc. G Marc Ecko. G Yakira, L.L.C. 20100041 G Macquarie Group Limited. G Lincoln National Corporation. G Delaware Management Holdings, Inc. 28–OCT–09 ...... 20090501 G AOl Bedding Super Holdings, LLC. G Thomas H. Lee Equity Fund V, L.P. G THL–SC Bedding Company. 20090691 G Bayer AG. G Athenix Corp. G Athenix Corp. 20090792 G Abbott Laboratories. G Evalve, Inc. G Evalve, Inc. 20100035 G ViaSat, Inc. G WildBIue Holding, Inc. G WildBlue Holding, Inc. 29–OCT–09 ...... 20090405 G Schering-Plough Corporation. G Merck & Co., Inc. G Merck & Co., Inc.
For Further Information Contact: DEPARTMENT OF HEALTH AND Proposed Collection: Title: Office of Sandra M. Peay, Contact Representative, HUMAN SERVICES Urban Indian Health Programs (OUIHP) or Renee Hallman, Contact Uniform Data System (UDS). Type of Representative, Federal Trade Indian Health Service Information Collection Request: Initial Commission, Premerger Notification request and four year extension, for data Request for Public Comment: 60-Day Office, Bureau of Competition, Room H– collection to ensure compliance with Proposed Information Collection: legislative mandates and report to 303, Washington, DC 20580, (202) 326– Office of Urban Indian Health Congress and policymakers on program 3100. Programs Uniform Data System accomplishments. Form Number(s): By Direction of the Commission. AGENCY: Indian Health Service. New data collection. There are currently Donald S. Clark, no form numbers. Reporting formats are ACTION: Notice. Secretary. contained in the UDS Instruction [FR Doc. E9–27413 Filed 11–17–09; 8:45 am] SUMMARY: In compliance with Section Manual. Need and Use of Information BILLING CODE 6750–01–M 3506(c)(2)(A) of the Paperwork Collection: The Uniform Data System Reduction Act of 1995 which requires (UDS) contains the annual reporting 60 day advance opportunity for public requirements for the cluster of primary comment on proposed information health care and case management/ collection projects, the Indian Health outreach and referral grantees funded by Service (IHS) is publishing for comment the IHS. The UDS includes reporting a summary of a proposed information requirements for grantees of the OUIHP. collection to be submitted to the Office The authorizing statute is Title V of of Management and Budget (OMB) for Public Law 94–437, of the Indian Health review. Care Improvement Act, as amended. IHS
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will collect data in the UDS which will appropriate for monitoring and The table below provides: Types of be used to ensure compliance with the evaluating performance and reporting data collection instruments, Number of legislative mandates and report to on annual trends. Affected Public: Title respondents, Response per respondent, Congress and policymakers on program V funded Urban Indian health programs. Total annual responses, Average burden accomplishments. To meet these Type of Respondents: Title V Urban hour per response, and Total annual objectives, the OUIHP requires a core set Indian health programs. burden hours. of data collected annually that is
Responses Data collection instrument(s) Number of per respond- Total annual Average burden hour per response * Total annual respondents ent responses burden hours
Universal Report ...... 34 1 34 8.00 (480 min) ...... 272 American Indian/Alaska Native Re- 34 1 34 8.00 (480 min) ...... 272 port.
Total ...... 68 ...... 544 * For ease of understanding, burden hours are also provided in actual minutes.
There are no Capital Costs, Operating DEPARTMENT OF HEALTH AND collection of information to OMB for Costs, and/or Maintenance Costs to HUMAN SERVICES review and clearance. report. Request for Comments: Your written Food and Drug Administration Infectious Disease Issues in comments and/or suggestions are Xenotransplantation—(OMB Control invited on one or more of the following [Docket No. FDA–2009–N–0291] Number 0910–0456)—Extension points: (a) Whether the information Agency Information Collection The statutory authority to collect this collection activity is necessary to carry information is provided under sections out an agency function; (b) whether the Activities; Submission for Office of Management and Budget Review; 351 and 361 of the Public Health agency processes the information Service (PHS) Act (42 U.S.C. 262 and collected in a useful and timely fashion; Comment Request; Infectious Disease Issues in Xenotransplantation 264) and the provisions of the Federal (c) the accuracy of public burden Food, Drug, and Cosmetic Act that estimate (the estimated amount of time AGENCY: Food and Drug Administration, apply to drugs (21 U.S.C. 301 et seq.). needed for individual respondents to HHS. The PHS guideline recommends provide the requested information); (d) ACTION: Notice. procedures to diminish the risk of whether the methodology and transmission of infectious agents to the assumptions used to determine the SUMMARY: The Food and Drug xenotransplantation product recipient estimate are logical; (e) ways to enhance Administration (FDA) is announcing and to the general public. The PHS the quality, utility, and clarity of the that a proposed collection of guideline is intended to address public information being collected; and (f) information has been submitted to the health issues raised by ways to minimize the public burden Office of Management and Budget xenotransplantation, through through the use of automated, (OMB) for review and clearance under identification of general principles of electronic, mechanical, or other the Paperwork Reduction Act of 1995. prevention and control of infectious technological collection techniques or DATES: Fax written comments on the diseases associated with other forms of information technology. collection of information by December xenotransplantation that may pose a Send Comments and Requests for 18, 2009. hazard to the public health. The Further Information: Send your written collection of information described in comments and requests for more ADDRESSES: To ensure that comments on this guideline is intended to provide to information on the proposed collection the information collection are received, sponsors general guidance on the or requests to obtain a copy of the data OMB recommends that written following topics: (1) The development collection instrument(s) and comments be faxed to the Office of of xenotransplantation clinical instructions to: Ms. Betty Gould, Information and Regulatory Affairs, protocols, (2) the preparation of Reports Clearance Officer, 801 OMB, Attn: FDA Desk Officer, FAX: submissions to FDA, and (3) the Thompson Avenue, TMP, Suite 450, 202–395–6974, or e-mailed to _ conduct of xenotransplantation clinical Rockville, MD 20852; call non-toll free oira [email protected]. All trials. Also, the collection of (301) 443–7899; send via facsimile to comments should be identified with the information will help ensure that the (301) 443–9879; or send your e-mail OMB control number 0910–0456. Also sponsor maintains important requests, comments, and return address include the FDA docket number found information in a cross-referenced system to: [email protected]. in brackets in the heading of this Comment Due Date: Your comments document. that links the relevant records of the xenotransplantation product recipient, regarding this information collection are FOR FURTHER INFORMATION CONTACT: Liz best assured of having full effect if xenotransplantation product, source Berbakos, Office of Information animal(s), animal procurement center, received within 60 days of the date of Management (HFA–710), Food and Drug this publication. and significant nosocomial exposures. Administration, 5600 Fishers Lane, The PHS guideline describes an Dated: November 10, 2009. Rockville, MD 20857, 301–796–3792, occupational health service program for Yvette Roubideaux, [email protected]. the protection of health care workers Director, Indian Health Service. SUPPLEMENTARY INFORMATION: In involved in xenotransplantation [FR Doc. E9–27540 Filed 11–17–09; 8:45 am] compliance with 44 U.S.C. 3507, FDA procedures, caring for BILLING CODE 4165–16–M has submitted the following proposed xenotransplantation product recipients,
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and performing associated laboratory that have presented problems in human recipients, products, source animals, testing. The guideline also describes a to human transplantation and are animal procurement centers, and public health need for a national therefore thought to share certain nosocomial exposures. Respondents to xenotransplantation database, which is characteristics with viruses that may this collection of information are the currently under development by the pose potential risks in sponsors of clinical studies of PHS. The PHS guideline is intended to xenotransplantation. These investigational xenotransplantation protect the public health and to help characteristics include long latency products under investigational new ensure the safety of using periods and the ability to establish drug applications (INDs) and xenotransplantation products in persistent infections. Several also share xenotransplantation product humans by preventing the introduction, the possibility of transmission among procurement centers, referred to as transmission, and spread of infectious individuals through intimate contact source animal facilities. There are an diseases associated with with human body fluids. Human estimated 12 respondents who are xenotransplantation. The PHS guideline immunodeficiency virus (HIV) and sponsors of INDs that include protocols also recommends that certain specimens Human T-lymphotropic virus are for xenotransplantation in humans. and records be maintained for 50 years human retroviruses. Retroviruses Other respondents for this collection of beyond the date of the contain ribonucleic acid that is reverse- information are an estimated 18 source xenotransplantation. These include: (1) transcribed into deoxyribonucleic acid animal facilities that provide source Records linking each (DNA) using an enzyme provided by the xenotransplantation product material to xenotransplantation product recipient virus and the human cell machinery. sponsors for use in human with relevant health records of the That viral DNA can then be integrated xenotransplantation procedures. These source animal, herd or colony, and the into the human cellular DNA. Both 18 source animal facilities keep medical specific organ, tissue, or cell type viruses establish persistent infections records of the herds/colonies as well as included in or used in the manufacture and have long latency periods before the the medical records of the individual of the product (3.2.7.1); (2) aliquots of onset of disease, 10 years and 40 to 60 source animal(s). The total annual serum samples from randomly selected years, respectively. reporting and recordkeeping burden is animal and specific disease The human hepatitis viruses are not estimated to be approximately 156 investigations (3.4.3.1); (3) source retroviruses, but several share with HIV hours. The burden estimates are based animal biological specimens designated the characteristic that they can be on FDA’s records of for PHS use (3.7.1); animal health transmitted through body fluids, can records (3.7.2), including necropsy establish persistent infections, and have xenotransplantation-related INDs and results (3.6.4); and (4) recipients’ long latency periods, e.g., approximately estimates of time required to complete biological specimens (4.1.2). The 30 years for Hepatitis C. In addition, the the various reporting and recordkeeping retention period is intended to assist PHS guideline recommends that a tasks described in the guideline. FDA health care practitioners and officials in record system be developed that allows does not expect the level of clinical surveillance and in tracking the source easy, accurate, and rapid linkage of studies using xenotransplantation to of an infection, disease, or illness that information among the specimen increase significantly in the next few might emerge in the recipient, the archive, the recipient’s medical records, years. source animal, or the animal herd or and the records of the source animal for In the Federal Register of July 10, colony after a xenotransplantation. The 50 years. The development of such a 2009 (74 FR 33260), FDA published a recommendation for maintaining record system is a one-time burden. notice requesting public comment on records for 50 years is based on clinical Such a system is intended to cross- the proposed collection of information. experience with several human viruses reference and locate relevant records of No comments were received.
TABLE 1.—REPORTING RECOMMENDATIONS
PHS Guideline Section Description
3.2.7.2 Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations.
3.4 Standard operating procedures (SOPs) of source animal facility should be available to review bodies.
3.5.1 Include increased infectious risk in informed consent if source animal quarantine period of 3 weeks is shortened.
3.5.4 Sponsor to make linked records described in section 3.2.7 available for review.
3.5.5 Source animal facility to notify clinical center when infectious agent is identified in source animal or herd after xenotransplantation product procurement.
TABLE 2.—RECORDKEEPING RECOMMENDATIONS
PHS Guideline Section Description
3.2.7 Establish records linking each xenotransplantation product recipient with relevant records.
4.3 Sponsor to maintain cross-referenced system that links all relevant records (recipient, product, source animal, animal procurement center, and nosocomial exposures).
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TABLE 2.—RECORDKEEPING RECOMMENDATIONS—Continued
PHS Guideline Section Description
3.4.2 Document results of monitoring program used to detect introduction of infectious agents which may not be apparent clinically.
3.4.3.2 Document full necropsy investigations including evaluation for infectious etiologies.
3.5.1 Justify shortening a source animal’s quarantine period of 3 weeks prior to xenotransplantation product procurement.
3.5.2 Document absence of infectious agent in xenotransplantation product if its presence elsewhere in source animal does not preclude using it.
3.5.4 Add summary of individual source animal record to permanent medical record of the xenotransplantation product re- cipient.
3.6.4 Document complete necropsy results on source animals (50-year record retention).
3.7 Link xenotransplantation product recipients to individual source animal records and archived biologic specimens.
4.2.3.2 Record base-line sera of xenotransplantation health care workers and specific nosocomial exposure.
4.2.3.3 and 4.3.2 Keep a log of health care workers’ significant nosocomial exposure(s).
4.3.1 Document each xenotransplant procedure.
5.2 Document location and nature of archived PHS specimens in health care records of xenotransplantation product re- cipient and source animal.
FDA estimates the burden of this collection of information as follows:
TABLE 3.—ESTIMATED ANNUAL REPORTING BURDEN1
PHS Guideline No. of Annual Frequency Total Annual Hours per Section Respondents per Response Responses Response Total Hours
3.2.7.22 1 1 1 0.5 0.5
3.43 12 0 .17 2 0.08 0 .16
3.5.14 12 0.08 (0–1) 1 0 .25 0.25
3.5.45 12 1 12 0.5 6.0
3.5.54 18 0.06 (0–1) 1 0 .2 0 .2
Total 7.11 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 No animal facility or sponsor has ceased operations in the last 3 years, however, we are using 1 for estimation purposes. 3 FDA’s records indicate that an average of two INDs are expected to be submitted per year. 4 To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence. 5 Based on an estimate of 36 patients treated over a 3-year period, the average number of xenotransplantation product recipients per year is estimated to be 12.
TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
PHS Guideline No. of Annual Frequency Total Annual Hours per Section Recordkeepers per Recordkeeping Records Record Total Hours
3.2.72 1 1 1 16 16 .0
4.33 12 1 12 0 .83 9.96
3.4.24 12 11 132 0.25 33 .0
3.4.3.25 18 4 72 0.3 21.6
3.5.16 12 0.08 (0–1) 1 0 .5 0 .5
3.5.26 12 0.08 (0–1) 1 0 .25 0.25
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TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
PHS Guideline No. of Annual Frequency Total Annual Hours per Section Recordkeepers per Recordkeeping Records Record Total Hours
3.5.4 12 1 12 0 .17 2.04
3.6.47 12 2 24 0.25 6 .0
3.77 18 1 .33 24 0 .08 1.92
4.2.3.28 12 25 300 0 .17 51 .0
4.2.3.26 12 0 .08 (0–1) 1 0.17 0 .17
4.2.3.3 and 4.3.26 12 0.08 (0–1) 1 0 .17 0.17
4.3.1 12 1 12 0 .25 3.0
5.29 12 3 36 0 .08 2.88
Total 148.49 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA estimates one new sponsor annu- ally. 3 FDA estimates there is minimal recordkeeping burden associated with maintaining the record system. 4 Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are approximately 6 sentinel animals per herd x 1 herd per facility x 18 facilities = 108 sentinel animals. There are approximately 24 source animals per year (see footnote 7 of this table); 108 + 24 = 132 monitoring records to document. 5 Necropsy for animal deaths of unknown cause estimated to be approximately 4 per herd per year x 1 herd per facility x 18 facilities = 72. 6 Has not occurred in the past 3 years and is expected to continue to be a rare occurrence. 7 On average two source animals are used for preparing xenotransplantation product material for one recipient. The average number of source animals is 2 source animals per recipient x 12 recipients annually = 24 source animals per year. (See footnote 5 of table 3 of this document.) 8 FDA estimates there are approximately 12 clinical centers doing xenotransplantation procedures x approximately 25 health care workers in- volved per center = 300 health care workers. 9 Twenty-four source animal records + 12 recipient records = 36 total records.
Because of the potential risk for cross- OMB control numbers as follows: (1) experience with xenotransplantation, species transmission of pathogenic ‘‘Current Good Manufacturing Practice that any xenotransplantation product persistent virus, the guideline for Finished Pharmaceuticals,’’ 21 CFR subject to FDA regulation within the recommends that health records be 211.1 through 211.208, approved under next 3 years will most likely be retained for 50 years. Because these OMB control number 0910–0139; (2) regulated as a biological product.) records are medical records, the ‘‘Investigational New Drug However, FDA recognized that some of retention of such records for up to 50 Application,’’ 21 CFR 312.1 through the information collections go beyond years is not information subject to the 312.160, approved under OMB control approved collections; assessments for PRA (5 CFR 1320.3(h)(5)). Also, because number 0910–0014; and (3) information these burdens are included in tables 1 of the limited number of clinical studies included in a license application, 21 through 4. with small patient populations, the CFR 601.2, approved under OMB In table 5 of this document, FDA number of records is expected to be control number 0910–0338. (Although it identifies those collection of insignificant at this time. Information is possible that a xenotransplantation information activities that are already collections in this guideline not product may not be regulated as a encompassed by existing regulations or included in tables 1 through 4 of this biological product (e.g., it may be are consistent with voluntary standards document can be found under existing regulated as a medical device), FDA which reflect industry’s usual and regulations and approved under the believes, based on its knowledge and customary business practice.
TABLE 5.—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS
PHS Guideline 21 CFR Section (unless other- Section Description of Collection of Information Activity wise stated)
2.2.1 Document off-site collaborations 312.52
2.5 Sponsor ensures counseling patient + family + contacts 312.62(c)
3.1.1 and 3.1.6 Document well-characterized health history and lineage of source animals 312.23(a)(7)(a) and 211.84
3.1.8 Registration with and import permit from the Centers for Disease Control and 42 CFR 71.53 Prevention
3.2.2 Document collaboration with accredited microbiology labs 312.52
3.2.3 Procedures to ensure the humane care of animals 9 CFR parts 1, 2, and 3 and PHS Policy1
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TABLE 5.—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS—Continued
PHS Guideline 21 CFR Section (unless other- Section Description of Collection of Information Activity wise stated)
3.2.4 Procedures consistent for accreditation by the Association for Assessment and AAALAC International Rules of Accreditation of Laboratory Animal Care International (AAALAC International) Accreditation2 and NRC and consistent with the National Research Council’s (NRC) Guide Guide3
3.2.5, 3.4, and 3.4.1 Herd health maintenance and surveillance to be documented, available, and in 211.100 and 211.122 accordance with documented procedures; record standard veterinary care
3.2.6 Animal facility SOPs PHS Policy1
3.3.3 Validate assay methods 211.160(a)
3.6.1 Procurement and processing of xenografts using documented aseptic conditions 211.100 and 211.122
3.6.2 Develop, implement, and enforce SOP’s for procurement and screening proc- 211.84(d) and 211.122(c) esses
3.6.4 Communicate to FDA animal necropsy findings pertinent to health of recipient 312.32(c)
3.7.1 PHS specimens to be linked to health records; provide to FDA justification for 312.23(a)(6) types of tissues, cells, and plasma, and quantities of plasma and leukocytes collected
4.1.1 Surveillance of xenotransplant recipient; sponsor ensures documentation of sur- 312.23(a)(6)(iii)(f) and veillance program life-long (justify >2 yrs.); investigator case histories (2 yrs. (a)(6)(iii)(g), and 312.62(b) After investigation is discontinued) and (c)
4.1.2 Sponsor to justify amount and type of reserve samples 211.122
4.1.2.2 System for prompt retrieval of PHS specimens and linkage to medical records 312.57(a) (recipient and source animal)
4.1.2.3 Notify FDA of a clinical episode potentially representing a xenogeneic infection 312.32
4.2.2.1 Document collaborations (transfer of obligation) 312.52
4.2.3.1 Develop educational materials (sponsor provides investigators with information 312.50 needed to conduct investigation properly)
4.3 Sponsor to keep records of receipt, shipment, and disposition of investigative 312.57 and 312.62(b) drug; investigator to keep records of case histories 1 The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (http://www.grants.nih.gov/grants/olaw/references/ phspol.htm). (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document pub- lishes in the Federal Register.) 2 AAALAC International Rules of Accreditation (http://www.aaalac.org/accreditation/rules.cfm). (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) 3 The NRC’s ‘‘Guide for the Care and Use of Laboratory Animals’’ (1996).
Dated: November 12, 2009. Paperwork Reduction Act (44 U.S.C. text message support; (2) a recovery- David Horowitz, Chapter 35). To request a copy of these oriented social networking site; and (3) Assistant Commissioner for Policy. documents, call the SAMHSA Reports a family program. Approximately 200 [FR Doc. E9–27658 Filed 11–17–09; 8:45 am] Clearance Officer on (240) 276–1243. adolescent respondents will be asked to complete 4 data collection forms (some BILLING CODE 4160–01–S Project: Recovery Services for repeated) during 5 interviews (baseline Adolescents and Families—New and 4 follow-ups) over a 12 month DEPARTMENT OF HEALTH AND The Substance Abuse and Mental period after enrollment or discharge HUMAN SERVICES Health Services Administration’s from treatment. Approximately 200 (SAMHSA) Center for Substance Abuse collateral respondents (i.e., a parent/ Substance Abuse and Mental Health Treatment will conduct a data collection guardian/concerned other) will be asked Services Administration on the helpfulness of recovery support to complete 7 data collection forms (some repeated) during 5 interviews Agency Information Collection services for young people and their (baseline and 4 follow-ups) over a 12 Activities: Submission for OMB families after leaving substance abuse month period after their adolescent’s Review; Comment Request treatment. Specifically, the Recovery Services for Adolescents and Families enrollment or discharge from treatment. Periodically, the Substance Abuse and (RSAF) project is evaluating a pilot test Approximately 15 to 20 project staff Mental Health Services Administration of the following recovery support respondents, including Project (SAMHSA) will publish a summary of services for young people and their Coordinators, Telephone Support information collection requests under families find the following recovery Volunteers, a Social Network Site OMB review, in compliance with the support services helpful: (1) Telephone/ Moderator, Family Program Clinicians,
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and a Support Services Supervisor, will gathered as part of this instrument in project’s social networking site. It is be asked to complete between 2 and 5 support of performance measurement administered at each of the follow-up data collection forms at varying for SAMHSA programs. It is timepoints by project staff. intervals during the delivery of recovery administered by project staff at each of • Self-Evaluation Questionnaire support services. Across all the follow-up timepoints. (SEQ). The SEQ contains 40 multiple respondents, a total of 28 data collection • Supplemental Assessment Form choice items that ask the collateral forms will be used. Depending on the (SAF 0309). The SAF contains 72 about feelings and symptoms of anxiety. time interval and task, information questions that are a combination of It is administered at each of the follow- collections will take anywhere from multiple choice, yes/no, and open- up timepoints by project staff. about 5 minutes to 2 hours to complete. ended formats. Content areas include: • Family Environment Scale (FES). A description of each data collection race, happiness with parent or caregiver The FES contains 18 yes/no items that form follows: in several life areas, participation in measure family cohesion and conflict. It prosocial activities, receipt of and is administered at each of the follow-up Adolescent Participant satisfaction with telephone support • timepoints by project staff. Global Appraisal of Individual services, and usage of and satisfaction • Relationship Happiness Scale Needs—Initial (GAIN–I 5.6.0 Full). The with the project’s social networking site. (Caregiver Version). The Relationship GAIN is an evidence-based assessment It is administered by project staff at each Happiness Scale contains 8 items that used with both adolescents and adults of the follow-up timepoints. ask the collateral about happiness with and in outpatient, intensive outpatient, his/her relationship with the adolescent partial hospitalization, methadone, Collateral Participant (Parent/ respondent in various life areas. It is short-term residential, long-term Guardian) administered at each of the follow-up residential, therapeutic community, and • Global Appraisal of Individual timepoints by project staff. correctional programs. There are over Needs—Collateral Monitoring—Initial 1,000 questions in this initial version (GCI). The GCI contains over 200 items Project Coordinator that are in multiple formats, including in this initial version that are in • Eligibility Checklist. The Eligibility multiple choice, yes/no, and open- multiple formats, including multiple Checklist contains 12 yes/no items that ended. Eight content areas are covered: choice, yes/no, and open-ended. The are used to determine whether or not an Background, Substance Use, Physical following content areas are covered: adolescent meets inclusion/exclusion Health, Risk Behaviors and Disease relationship to the adolescent criteria for the project and is eligible to Prevention, Mental and Emotional respondent, background, and the be approached for informed consent. It Health, Environment and Living adolescent’s background and substance is completed prior to informed consent Situation, Legal, and Vocational. Each use, environment and living situation, by project staff. section contains questions on the and vocational information. There are • recency of problems, breadth of questions on the recency of problems, Telephone Support Volunteer symptoms, and recent prevalence as breadth of symptoms, and recent Notification Form. This form contains a well as lifetime service utilization, prevalence as well as lifetime service participant’s name and contact recency of utilization, and frequency of utilization, recency of utilization, and information. It is completed by project recent utilization. GPRA data are frequency of recent utilization. It is staff and given to volunteers to notify gathered as part of this instrument in administered at baseline by project staff. them when someone is assigned to support of performance measurement • Global Appraisal of Individual receive telephone support. • for SAMHSA programs. It is Needs—Collateral Monitoring— Family Program Notification Form. administered at intake into treatment by Monitoring (GCM 5.3.3). The GCM This form contains a participant’s name. clinical staff and used as baseline data contains over 200 items in this follow- It is completed by project staff and given for the project. up version that are in multiple formats, to clinicians to notify them when • Global Appraisal of Individual including multiple choice, yes/no, and someone is assigned to the family Needs—Monitoring 90 Days (GAIN–M90 open-ended. The following content support group. 5.6.0 Full). The GAIN is an evidence- areas are covered: relationship to the • Follow-Up Locator Form— based assessment used with both adolescent respondent, background, and Participant (FLF–P). The FLF–P adolescents and adults and in the adolescent’s background and contains over 50 items that are a outpatient, intensive outpatient, partial substance use, environment and living combination of yes/no, multiple choice, hospitalization, methadone, short-term situation, and vocational information. and open-ended formats. At the time of residential, long-term residential, There are questions on the recency of informed consent, data are gathered by therapeutic community, and problems, breadth of symptoms, and project staff about an adolescent’s correctional programs. There are over recent prevalence as well as lifetime contact information, personal contacts, 500 questions in this follow-up version service utilization, recency of criminal justice contacts, school/job that are in multiple formats, including utilization, and frequency of recent contacts, hang-out information, Internet multiple choice, yes/no, and open- utilization. It is administered at each of contacts, and identifying information in ended. Eight content areas are covered: the follow-up timepoints by project order to locate and interview that Background, Substance Use, Physical staff. adolescent over multiple follow-up Health, Risk Behaviors and Disease • Supplemental Assessment Form— intervals. Prevention, Mental and Emotional Collateral (SAF—Collateral). The SAF • Follow-Up Locator Form— Health, Environment and Living contains 72 questions that are a Collateral (FLF–C). The FLF–C contains Situation, Legal, and Vocational. Each combination of multiple choice, yes/no, over 50 items that are a combination of section contains questions on the and open-ended formats. Content areas yes/no, multiple choice, and open- recency of problems, breadth of include: knowledge about the ended formats. Data are gathered about symptoms, and recent prevalence as adolescent’s participation in prosocial a collateral’s contact information, well as lifetime service utilization, activities, receipt of and satisfaction personal contacts, and job contacts in recency of utilization, and frequency of with telephone support services, and order to locate and interview that recent utilization. GPRA data are usage of and satisfaction with the collateral over multiple follow-up
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intervals. It is administered at the time telephone support ends for each participant end involvement in the of informed consent by project staff. adolescent. family support program. • • Follow-Up Contact Log. The Volunteer/Staff Survey (Telephone • Volunteer/Staff Survey—See Follow-Up Contact Log is open-ended Support Volunteer)—See Volunteer/ Volunteer/Staff Survey (Project and provides space for all data collected Staff Survey (Project Coordinator) Coordinator) above. during attempted and completed follow- above. Support Services Supervisor up contacts, over the phone and in- Social Network Site Moderator person, to be recorded. It is completed • Adolescent Telephone Support • Social Networking Moderator Log. throughout the follow-up time period. Quality Assurance Checklist. This • The Social Networking Moderator Log Volunteer/Staff Survey. The checklist contains 43 items that ask the Volunteer/Staff Survey contains 10 contains 11 fields for the moderator to record usage data for the project’s social supervisor to rate how well a telephone items in fill-in-the-blank, yes/no, and support volunteer delivered required multiple choice formats. Items ask about networking site. The moderator tracks number of visits to the site, number of service components to adolescents. background, demographic information, Volunteers are rated on a scale of 1 and role in the project. It is completed unique visitors, messages posted, chat room attendance, and problems with through 5 in the following areas: once by all volunteers and staff at the substance use since last call (no use), start of the project. users. This form is completed weekly by project staff. substance use since last call (use), Telephone Support Volunteer • Volunteer/Staff Survey—See substance use since last call (still using), substance use since last call (stopped • Telephone Support Case Review Volunteer/Staff Survey (Project Coordinator) above. using), attendance at 12-step meetings, Form. The Telephone Support Case recovery-related activities, activities Review Form contains multiple rows Family Program Clinician related to global health, follow-up since that allow a volunteer to record 5 pieces • Family Program Progress Notes. last call, closing the call, overall, general of data about adolescents that they make The Family Program Progress Notes clinical skills, and overall difficulty of phone calls to: initials, treatment form is open-ended and provides space session. This form is completed for each discharge status/date, weeks since for all data collected during attempted reviewed recording of a telephone treatment discharge, date of last and completed family program contacts session by a supervisor. telephone session, and number of to be recorded. This form is completed • Social Networking Quality completed telephone sessions since by the clinician throughout the time Assurance Checklist. This checklist discharge. This allows the volunteer and family members are active in the family contains 17 items that ask the supervisor to monitor the progress of support program. supervisor to rate how well a social active cases. The form is completed by • Family Program Attendance Log. networking site moderator delivered the volunteers every week. The Family Program Attendance Log is required service components to • Telephone Support Call Log. The used to record 6 pieces of information adolescents. The moderator is rated on Telephone Support Call Log is open- about each attempted session: Session a scale of 1 through 5 in the following ended and provides space for all data number, scheduled date, was the areas: group discussions, administrative collected during attempted and session rescheduled (yes/no), was the tasks, overall, and general skills. This completed support contacts to be family member a no-show (yes/no), did form is completed for each review of the recorded. The form is completed by the the family member attend the session social networking site by a supervisor. volunteer throughout the period of (yes/no), and comments. This form is • Family Program QA Checklist. This telephone support. completed by the clinician throughout checklist contains 72 items that ask the • Adolescent Telephone Support the time family members are active in supervisor to rate how well a family Documentation Form. The Adolescent the family support program. Telephone Support Documentation • Family Program Case Review program clinician delivered required Form contains 22 items that are asked Report. The Family Program Case service components to family members. of an adolescent during a telephone Review Report contains multiple rows The clinician is rated on a scale of 1 support contact by a volunteer. The that allow a clinician to record through 5 in the following areas: initial form is used to record yes/no and open- information that allows the clinician meeting motivational strategies, ended responses to questions asking and supervisor to monitor the progress domestic violence precautions, about substance use and recovery- of active cases. Areas asked about functional analysis of substance use, related activities. The volunteers include: family program procedures positive communication skills, use of complete the form every time there is a delivered, date of last session, and positive reinforcement, time out from telephone support session with an weeks in family program. This form is positive reinforcement, allowing the adolescent. completed by the clinician weekly identified patient to experience the • Telephone Support Discharge Form. throughout the time family members are natural consequences of substance use, The Telephone Support Discharge Form active in the family support program. helping concerned significant others’ contains 10 fields to record the • Family Program Discharge Form. enrich their own lives, maintaining the following information at the end of an The Family Program Discharge Form identified patient in recovery-oriented adolescent’s participation in telephone contains 9 fields to record the following systems of care, and general. This form support: adolescent name, today’s date, information at the end of participation is completed for each reviewed volunteer name, notification date, in the family program: caregiver name, recording of a family session by a telephone support intake date, today’s date, adolescent name, supervisor. telephone support discharge date, notification date, clinician name, family • Volunteer/Staff Survey—See reason for discharge, number of program intake date, family program Volunteer/Staff Survey (Project completed sessions, referral for more discharge date, reason for discharge, and Coordinator) above. intervention, and successful contact for number of completed sessions. This The following table is a list of the more intervention. This form is form is completed by the clinician each hour burden of the information completed by volunteers when time family members of a given collection by form and by respondent:
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DETAILED INFORMATION ON FORMS GROUPED BY RESPONDENT
Responses Total Instrument/form Number of per respond- Total Hours per annualized hour respondents ent responses response burden *
Adolescent Participant
GAIN–I 5.6.0 Full ...... 200 1 200 2 400
GAIN–M90 5.6.0 Full ...... 200 4 800 1 800 SAF ...... 200 5 1,000 .25 250
Subtotal ...... 200 ...... 2,000 ...... 1,450
Collateral (Parent/Guardian/Concerned Other) Participant
Collateral-I ...... 200 1 200 .25 50 Collateral-M ...... 200 4 800 .25 200 Collateral SAF ...... 200 5 1,000 .25 250 Self-Evaluation Questionnaire ...... 200 5 1,000 .16 250 Family Environment Scale (Cohesion and Conflict Scales) ...... 200 5 1,000 .08 80 Relationship Happiness Scale (Caregiver) ...... 200 5 1,000 .08 80
Subtotal ...... 200 ...... 5,000 ...... 910
Project Coordinator
Eligibility Checklist ...... 4 50 200 .25 50 Locator—Participant ...... 4 50 200 .32 64 Locator—Collateral ...... 4 50 200 .25 50 Follow-Up Contact Log ...... 4 50 200 .16 32 Telephone Support Volunteer Notification Form ...... 4 50 200 .16 32 Family Program Notification Form ...... 4 50 200 .16 32 Volunteer/Staff Survey ...... 4 1 4 .25 1
Subtotal ...... 4 ...... 1,204 ...... 261
Telephone Support Volunteer
Telephone Support Case Review Form ...... 8 450 3,600 .25 900 Telephone Support Call Log ...... 8 25 200 .16 32 Telephone Support Documentation Form ...... 8 450 3,600 .5 1,800 Telephone Support Discharge Form ...... 8 25 200 .16 32 Volunteer/Staff Survey ...... 8 1 8 .25 2
Subtotal ...... 8 ...... 7,608 ...... 2,766
Social Network Site Moderator
Social Networking Moderator Log ...... 1 52 52 .5 26 Volunteer/Staff Survey ...... 1 1 1 .25 .25
Subtotal ...... 1 ...... 53 ...... 26 .25
Family Program Clinician
Family Program Progress Notes ...... 4 650 2,600 .16 416 Family Program Attendance Log ...... 4 50 200 .08 16 Family Program Case Review Form ...... 4 650 2,600 .25 650 Family Program Discharge Form ...... 4 50 200 .16 32 Volunteer/Staff Survey ...... 4 1 4 .25 1
Subtotal ...... 4 ...... 5,604 ...... 1,115
Support Services Supervisor
Telephone Support QA Checklist ...... 1 12 12 1 12 Social Networking QA Checklist ...... 1 12 12 .5 6 Family Program QA Checklist ...... 1 12 12 1 12 Volunteer/Staff Survey ...... 1 1 1 .25 .25
Subtotal ...... 1 ...... 37 ...... 30 .25
Total ...... 418 ...... 21,506 ...... 6,558 .50
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ANNUALIZED SUMMARY TABLE
Total Respondents Number of Total annualized hour respondents responses burden *
Adolescent ...... 200 2,000 1,450 Collateral ...... 200 5,000 910 Project Coordinator ...... 4 1,204 261 Telephone Support Volunteer ...... 8 7,608 2,766 Social Network Site Moderator ...... 1 53 26 .25 Family Program Clinician ...... 4 5,604 1,115 Support Services Supervisor ...... 1 37 30 .25
Total ...... 418 21,506 6,558 .50
Written comments and DATES: Submit written or electronic validity of the methodology and recommendations concerning the comments on the collection of assumptions used; (3) ways to enhance proposed information collection should information by January 19, 2010. the quality, utility, and clarity of the be sent by December 18, 2009 to: ADDRESSES: Submit electronic information to be collected; and (4) SAMHSA Desk Officer, Human comments on the collection of ways to minimize the burden of the Resources and Housing Branch, Office information to http:// collection of information on of Management and Budget, New www.regulations.gov. Submit written respondents, including through the use Executive Office Building, Room 10235, comments on the collection of of automated collection techniques, Washington, DC 20503; due to potential information to the Division of Dockets when appropriate, and other forms of delays in OMB’s receipt and processing Management (HFA–305), Food and Drug information technology. of mail sent through the U.S. Postal Administration, 5630 Fishers Lane, rm. Service, respondents are encouraged to 1061, Rockville, MD 20852. All Experimental Study of Nutrition Facts submit comments by fax to: 202–395– comments should be identified with the Label Formats—(Section 903(d)(2)(C) of 5806. docket number found in brackets in the the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(C))) (OMB Dated: November 12, 2009. heading of this document. Control Number 0910–NEW) Elaine Parry, FOR FURTHER INFORMATION CONTACT: Director, Office of Program Services. Denver Presley, Jr., Office of Information I. Description [FR Doc. E9–27641 Filed 11–17–09; 8:45 am] Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Nutrition information is required on BILLING CODE 4162–20–P Rockville, MD 20857, 301–796–3793. most packaged foods and this SUPPLEMENTARY INFORMATION: Under the information must be provided in a DEPARTMENT OF HEALTH AND PRA (44 U.S.C. 3501–3520), Federal specific format as defined in 21 CFR HUMAN SERVICES agencies must obtain approval from the 101. 9. When FDA was determining Office of Management and Budget which Nutrition Facts label format to Food and Drug Administration (OMB) for each collection of require, the agency undertook consumer [Docket No. FDA–2009–N–0532] information they conduct or sponsor. research to evaluate alternatives (Refs. 1, ‘‘Collection of information’’ is defined 2, and 3). More recently, FDA Agency Information Collection in 44 U.S.C. 3502(3) and 5 CFR conducted qualitative consumer Activities; Proposed Collection; 1320.3(c) and includes agency requests research on the format of the Nutrition Comment Request; Experimental or requirements that members of the Facts label on behalf of the agency’s Study of Nutrition Facts Label Formats public submit reports, keep records, or Obesity Working Group (OWG) (Ref. 4), provide information to a third party. which was formed in 2003 and tasked AGENCY: Food and Drug Administration, Section 3506(c)(2)(A) of the PRA (44 with outlining a plan to help confront HHS. U.S.C. 3506(c)(2)(A)) requires Federal the problem of obesity in the United ACTION: Notice. agencies to provide a 60-day notice in States (Ref. 5). In addition to conducting consumer research, in response to the SUMMARY: The Food and Drug the Federal Register concerning each Administration (FDA) is announcing an proposed collection of information, OWG plan FDA issued two Advance opportunity for public comment on the before submitting the collection to OMB Notices of Proposed Rulemaking proposed collection of certain for approval. To comply with this (ANPRM) requesting comments on information by the agency. Under the requirement, FDA is publishing notice format changes to the Nutrition Facts Paperwork Reduction Act of 1995 (the of the proposed collection of label. One ANPRM requested comments PRA), Federal agencies are required to information set forth in this document. on whether and, if so, how to give publish notice in the Federal Register With respect to the following greater emphasis to calories on the concerning each proposed collection of collection of information, FDA invites Nutrition Facts label (Ref. 6) and the information, and to allow 60 days for comments on these topics: (1) Whether other requested comments on whether public comment in response to the the proposed collection of information and, if so, how to amend the agency’s notice. This notice solicits comments on is necessary for the proper performance serving size regulations (Ref. 7). In 2007, an experimental study of Nutrition Facts of FDA’s functions, including whether FDA issued an ANPRM requesting label formats. the information will have practical comments on whether the agency utility; (2) the accuracy of FDA’s should require that certain nutrients be * Total Annualized Hour Burden = Total estimate of the burden of the proposed added or removed from the Nutrition Responses × Hours per Response. collection of information, including the Facts label (Ref. 8).
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FDA conducts consumer research modifications to the Nutrition Facts overall healthfulness and (2) ability to under its broad statutory authority, set label format. The study is part of the use the Nutrition Facts label to, for forth in section 903(b)(2) of the Federal agency’s continuing effort to enable example, calculate calories and estimate Food, Drug, and Cosmetic Act (the act), consumers to make informed dietary serving sizes needed to meet objectives. to protect the public health by ensuring choices and construct healthful diets. To help understand consumer reactions, that foods are ‘‘safe, wholesome, The proposed study will use a Web- the study will also collect information sanitary, and properly labeled,’’ and in based experiment to collect information on participants’ background, including section 903(d)(2)(C) of the act, to from a sample of adult members in an but not limited to use of the Nutrition conduct research relating to foods, online consumer panel established by a Facts label and health status. drugs, cosmetics, and devices in contractor. The study plans to randomly The study results will be used to help carrying out the act. assign each of 3,600 participants to view FDA is proposing to conduct an Nutrition Facts labels from a set of the agency to understand whether experimental study to quantitatively Nutrition Facts labels that vary by the modifications to the Nutrition Facts assess consumer reactions to potential format, the type of food product, and the label format could help consumers to options for modifying the Nutrition quality of nutritional attributes of the make informed food choices. The results Facts label format. The purpose of the product. The study will focus on the of the experimental study will not be study is to help enhance FDA’s following types of consumer reactions: used to develop population estimates. understanding of consumer (1) Judgments about a food product in FDA estimates the burden of this comprehension and acceptance of terms of its nutritional attributes and collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Annual Frequency Total Annual Hours per Portion of Study Respondents per Response Responses Response Total Hours
Cognitive interview screener 96 1 96 0.083 8
Cognitive interview 12 1 12 1 12
Pretest invitation 1,000 1 1,000 0.033 33
Pretest 150 1 150 0.20 30
Experiment invitation 24,000 1 24,000 0.033 792
Experiment 3,600 1 3,600 0.20 720
Total 1,595 1There are no capital costs or operating and maintenance costs associated with this collection of information.
To help design and refine the hours + 720 hours). Thus, the total Restaurants,’’ Journal of Nutrition Education questionnaire to be used for the estimated burden is 1,595 hours. FDA’s and Behavior, 39: 157–163, 2007. experimental study, we plan to conduct burden estimate is based on prior 5. U.S. Food and Drug Administration, cognitive interviews by screening 96 experience with research that is similar Calories Count: Report of the Working Group adult consumers in order to obtain 12 to this proposed study. on Obesity, 2004 (http://www.fda.gov/Food/ LabelingNutrition/ReportsResearch/ participants in the interviews. Each II. References screening is expected to take 5 minutes ucm081696.htm). (0.083 hours) and each cognitive The following references have been 6. 70 FR 17008, April 4, 2005. 7. 70 FR 17010, April 4, 2005. interview is expected to take 1 hour. placed on display in the Division of 8. 72 FR 62149, November 2, 2007. The total for cognitive interview Dockets Management (see ADDRESSES), activities is 20 hours (8 hours + 12 and may be seen by interested persons Dated: November 12, 2009. hours). Subsequently, we plan to between 9 a.m. and 4 p.m., Monday David Horowitz, conduct pretests of the questionnaire through Friday. Assistant Commissioner for Policy. 1. Levy A., S. Fein, and R. Schucker, before it is administered in the study. [FR Doc. E9–27720 Filed 11–17–09; 8:45 am] We expect that 1,000 invitations, each ‘‘Nutrition Labeling Formats: Performance BILLING CODE 4160–01–S taking 2 minutes (0.033 hours), will and Preference,’’ Food Technology, 45: 116– need to be sent to adult members of an 121, 1991. 2. Levy A., S. Fein, and R. Schucker, ‘‘More online consumer panel to have 150 of Effective Nutrition Label Formats Are Not them complete a 12-minute (0.20 hours) Necessarily Preferred,’’ Journal of the pretest. The total for the pretest American Dietetic Association, 92: 1230– activities is 63 hours (33 hours + 30 1234, 1992. hours). For the experiment, we estimate 3. Levy A., S. Fein, and R. Schucker, that 24,000 invitations, each taking 2 ‘‘Performance Characteristics of Seven minutes (0.033 hours), will need to be Nutrition Label Formats,’’ Journal of Public sent to adult members of an online Policy and Marketing, 15: 1–15, 1996. 4. Lando A. and J. Labiner-Wolfe, ‘‘Helping consumer panel to have 3,600 of them Consumers to Make More Healthful Food complete a 12-minute (0.20 hours) Choices: Consumer Views on Modifying questionnaire. The total for the Food Labels and Providing Point-of-Purchase experiment activities is 1,512 hours (792 Nutrition Information at Quick-Service
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DEPARTMENT OF HEALTH AND User Fee Cover Sheet; Form FDA Respondents to this collection of HUMAN SERVICES 3397—(OMB Control Number 0910– information are new drug and biologics 0297)—Extension manufacturers. Based on FDA’s database Food and Drug Administration system for fiscal year (FY) 2008, there Under sections 735 and 736 of the [Docket No. FDA–2009–N–0251] are an estimated 255 manufacturers of Federal Food, Drug, and Cosmetic Act products subject to the user fee Agency Information Collection (the act) (21 U.S.C. 379g and 379h), the provisions of PDUFA. However, not all Activities; Submission for Office of Prescription Drug User Fee Act of 1992 manufacturers will have any Management and Budget Review; (PDUFA) (Public Law 102–571), as submissions, and some may have Comment Request; User Fee Cover amended by the Food and Drug multiple submissions in a given year. Sheet; Form FDA 3397 Administration Modernization Act of The total number of annual responses is 1997 (Public Law 105–115), the Public based on the number of submissions AGENCY: Food and Drug Administration, Health Security and Bioterrorism received by FDA in FY 2008. CDER HHS. Preparedness and Response Act of 2002, received 3,107 annual responses that ACTION: Notice. which includes the Prescription Drug include the following submissions: 147 User Fee Amendments of 2002 (Public new drug applications; 13 biologics SUMMARY: The Food and Drug Law 107–188), and most recently by the Administration (FDA) is announcing license applications; 1,813 that a proposed collection of Food and Drug Administration manufacturing supplements; 987 information has been submitted to the Amendments Act of 2007 (Public Law labeling supplements; and 147 efficacy Office of Management and Budget 110–85), FDA has the authority to assess supplements. CBER received 810 annual (OMB) for review and clearance under and collect user fees for certain drug responses that include the following the Paperwork Reduction Act of 1995. and biologics license applications and submissions: 9 biologics license supplements. Under this authority, applications; 743 manufacturing DATES: Fax written comments on the pharmaceutical companies pay a fee for supplements; 48 labeling supplements; collection of information by December certain new human drug applications, and 10 efficacy supplements. Based on 18, 2009. biologics license applications, or the previous submissions that were ADDRESSES: To ensure that comments on supplements submitted to the agency for received, the rate of these submissions the information collection are received, review. Because the submission of user is not expected to change significantly OMB recommends that written fees concurrently with applications and in the next few years. The estimated comments be faxed to the Office of supplements is required, review of an hours per response are based on past Information and Regulatory Affairs, application by FDA cannot begin until FDA experience with the various OMB, Attn: FDA Desk Officer, FAX: the fee is submitted. Form FDA 3397, submissions, and the average is 30 202–395–6974, or e-mailed to the user fee cover sheet, is designed to minutes. [email protected]. All provide the minimum necessary FDA is revising Form FDA 3397 in the comments should be identified with the information to determine whether a fee following ways: (1) By including an OMB control number 0910–0297. Also is required for review of an application, additional question regarding include the FDA docket number found to determine the amount of the fee redemption of a priority review in brackets in the heading of this required, and to account for and track voucher; (2) by deleting the exclusion document. user fees. The form provides a cross- for certain applications submitted under FOR FURTHER INFORMATION CONTACT: Liz reference of the fee submitted for an section 505(b)(2) of the act (21 U.S.C. Berbakos, Office of Information application by using a unique number 355(b)(2)); and (3) by making several Management (HFA–710), Food and Drug tracking system. The information minor editorial changes. Administration, 5600 Fishers Lane, collected is used by FDA’s Center for In the Federal Register of June 8, 2009 Rockville, MD 20857, 301–796–3792, Drug Evaluation and Research (CDER) (74 FR 27145), FDA published a 60-day [email protected]. and Center for Biologics Evaluation and notice requesting public comment on SUPPLEMENTARY INFORMATION: In Research (CBER) to initiate the the proposed collection of information. compliance with 44 U.S.C. 3507, FDA administrative screening of new drug No comments were received on the has submitted the following proposed applications, biologics license information collection. collection of information to OMB for applications, and supplemental FDA estimates the burden of this review and clearance. applications. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of Annual Frequency Total Annual Hours per Form Respondents per Response Responses Response Total Hours
FDA 3397 255 15.36 3,917 0.5 1,959 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: November 12, 2009. SUPPLEMENTARY INFORMATION: Under the Cosmetic Act (the act) (21 U.S.C. 351) David Horowitz, PRA (44 U.S.C. 3501–3520), Federal provides that drugs and devices Assistant Commissioner for Policy. agencies must obtain approval from the (including human blood and blood [FR Doc. E9–27719 Filed 11–17–09; 8:45 am] Office of Management and Budget components) are adulterated if they do BILLING CODE 4160–01–S (OMB) for each collection of not conform with current good information they conduct or sponsor. manufacturing practice (CGMP) assuring ‘‘Collection of information’’ is defined that they meet the requirements of the DEPARTMENT OF HEALTH AND in 44 U.S.C. 3502(3) and 5 CFR act. Establishments manufacturing HUMAN SERVICES 1320.3(c) and includes agency requests biological products including human or requirements that members of the blood and blood components must Food and Drug Administration public submit reports, keep records, or comply with the applicable CGMP provide information to a third party. regulations (parts 211, 606, and 820 (21 [Docket No. FDA–2009–N–0545] Section 3506(c)(2)(A) of the PRA (44 CFR parts 211, 606, and 820)) and Agency Information Collection U.S.C. 3506(c)(2)(A)) requires Federal current good tissue practice (CGTP) Activities; Proposed Collection; agencies to provide a 60-day notice in regulations (part 1271 (21 CFR part Comment Request; Biological the Federal Register concerning each 1271)) as appropriate. FDA regards BPD Products: Reporting of Biological proposed collection of information, reporting and HCT/P deviation Product Deviations and Human Cells, including each proposed extension of an reporting to be an essential tool in its Tissues, and Cellular and Tissue- existing collection of information, directive to protect public health by Based Product Deviations in before submitting the collection to OMB establishing and maintaining Manufacturing; Form FDA 3486 and for approval. To comply with this surveillance programs that provide Addendum 3486A requirement, FDA is publishing notice timely and useful information. of the proposed collection of Section 600.14, in brief, requires the AGENCY: Food and Drug Administration, information set forth in this document. manufacturer who holds the biological HHS. With respect to the following product license, for other than human ACTION: Notice. collection of information, FDA invites blood and blood components, and who comments on these topics: (1) Whether had control over a distributed product SUMMARY: The Food and Drug the proposed collection of information when the deviation occurred, to report Administration (FDA) is announcing an is necessary for the proper performance to the Center for Biologics Evaluation opportunity for public comment on the of FDA’s functions, including whether and Research (CBER) or to the Center for proposed collection of certain the information will have practical Drugs Evaluation and Research (CDER) information by the agency. Under the utility; (2) the accuracy of FDA’s as soon as possible but not to exceed 45 Paperwork Reduction Act of 1995 (the estimate of the burden of the proposed calendar days after acquiring PRA), Federal agencies are required to collection of information, including the information reasonably suggesting that a publish notice in the Federal Register validity of the methodology and reportable event has occurred. Section concerning each proposed collection of assumptions used; (3) ways to enhance 606.171, in brief, requires a licensed information including each proposed the quality, utility, and clarity of the manufacturer of human blood and blood extension of an existing collection of information to be collected; and (4) components, including Source Plasma; information, and to allow 60 days for ways to minimize the burden of the an unlicensed registered blood public comment in response to the collection of information on establishment; or a transfusion service notice. This notice solicits comments on respondents, including through the use who had control over a distributed the information collection requirements of automated collection techniques, product when the deviation occurred, to relating to the reporting of biological when appropriate, and other forms of report to CBER as soon as possible but product deviations (BPDs) and human information technology. not to exceed 45 calendar days after acquiring information reasonably cells, tissues, and cellular and tissue- Biological Products: Reporting of suggesting that a reportable event has based product (HCT/P) deviations, and Biological Product Deviations and occurred. Similarly § 1271.350(b), in Form FDA 3486 and Addendum 3486A. Human Cells, Tissues, and Cellular and brief, requires non-reproductive HCT/P DATES: Submit written or electronic Tissue-Based Product Deviations; Form establishments described in § 1271.10 to comments on the collection of FDA 3486 and Addendum 3486A (OMB report to CBER all HCT/P deviations information by January 19, 2010. Control Number 0910–0458)—Extension relating to a distributed HCT/P that ADDRESSES: Submit electronic Under section 351 of the Public relates to the core CGTP requirements, comments on the collection of Health Service Act (PHS Act) (42 U.S.C. if the deviation occurred in the information to: http:// 262), all biological products, including establishment’s facility or in a facility www.regulations.gov. Submit written human blood and blood components, that performed a manufacturing step for comments on the collection of offered for sale in interstate commerce the establishment under contract, information to the Division of Dockets must be licensed and meet standards, agreement or other arrangement. Form Management (HFA–305), Food and Drug including those prescribed in the FDA FDA 3486 is used to submit BPD reports Administration, 5630 Fishers Lane, rm. regulations, designed to ensure the and HCT/P deviation reports. 1061, Rockville, MD 20852. All continued safety, purity, and potency of Respondents to this collection of comments should be identified with the such products. In addition under information are the licensed docket number found in brackets in the section 361 of the PHS Act (42 U.S.C. manufacturers of biological products heading of this document. 264), FDA may issue and enforce other than human blood and blood FOR FURTHER INFORMATION CONTACT: regulations necessary to prevent the components, licensed manufacturers of Elizabeth Berbakos, Office of introduction, transmission, or spread of blood and blood components including Information Management (HFA–710), communicable diseases between the Source Plasma, unlicensed registered Food and Drug Administration, 5600 States or possessions or from foreign blood establishments, transfusion Fishers Lane, Rockville, MD 20857, countries into the States or possessions. services, and establishments that 301–796–3792. Further, the Federal Food, Drug, and manufacture non-reproductive HCT/Ps
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regulated solely under section 361 of the information when a BPD report has been addendum. CBER further estimates that PHS Act as described in § 1271.10. The reviewed by FDA and evaluated as a it would take between 10 to 20 minutes number of respondents and total annual possible recall. The additional to complete the addendum. For responses are based on the BPD reports information requested includes calculation purposes, CBER is using 15 and HCT/P deviation reports FDA information not contained in the Form minutes. received in fiscal year (FY) 2008. The FDA 3486 such as: (1) Distribution Activities such as investigating, number of licensed manufacturers and pattern, (2) method of consignee total annual responses under 21 CFR notification, (3) consignee(s) of products changing standard operating procedures 600.14 include the estimates for BPD for further manufacture, (4) additional or processes, and follow-up are reports submitted to both CBER and product information, (5) updated currently required under 21 CFR parts CDER. Based on the information from product disposition, and (6) industry 211, (approved under OMB control industry, the estimated average time to recall contacts. This information is number 0910–0139), part 606 (approved complete a deviation report is 2 hours. requested by CBER through e-mail under OMB control number 0910–0116), The availability of the standardized notification to the submitter of the BPD part 820 (approved under OMB control report form, Form FDA 3486, and the report. This information is used by number 0910–0073), and part 1271 are ability to submit this report CBER for recall classification purposes. approved under OMB Control No. 0910– electronically to CBER (CDER does not At this time Addendum 3486A is being 0543 and, therefore, are not included in currently accept electronic filings) used only for those BPD reports the burden calculation for the separate further streamlines the report submitted under § 606.171. CBER requirement of submitting a deviation submission process. estimates that 5 percent of the total BPD report to FDA. CBER has developed an addendum to reports submitted to CBER under FDA estimates the burden of this Form FDA 3486. The web-based § 606.171 would need additional addendum 3486A provides additional information submitted in the collection of information as follows:
ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR FDA Form No. of Annual Frequency Total Annual Hours per Section Number Respondents per Response Responses Response Total Hours
600.14 3486 51 7 .78 397 2.0 794
606.171 3486 1,533 28.78 44,125 2.0 88,250
1271.350(b) 3486 84 2.64 222 2 .0 444
3486A2 77 28.65 2,206 0 .25 551.5
Total 90,039.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Five percent of the number of respondents (1,533 x 0.05 = 77) and total annual responses to CBER (44,125 x 0.05 = 2,206).
Dated: November 12, 2009. Volume 74, Number 144 and allowed Guidelines, the National Heart, Lung, David Horowitz, 60-days for public comment. No public and Blood Institute (NHLBI) will Assistant Commissioner for Policy. comments were received. The purpose conduct a national public awareness [FR Doc. E9–27716 Filed 11–17–09; 8:45 am] of this notice is to allow an additional campaign to help parents understand BILLING CODE 4160–01–S 30 days for public comment. that risk for cardiovascular disease (CVD) begins in childhood, and to 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping engage them in encouraging healthy DEPARTMENT OF HEALTH AND Requirements: habits in their children to promote heart HUMAN SERVICES health and reduce their children’s CVD Final Rule requires that the agency risk now and as they grow. Currently, National Institutes of Health inform the potential persons who are to little is known about parental respond to the collection of information knowledge, attitudes, and behaviors Submission for OMB review; Comment that such persons are not required to related to heart health in children. Request; Parental Knowledge, respond to the collection of information Serving as a baseline for evaluation of Attitudes, and Behaviors Related to unless it displays a currently valid OMB NHLBI’s outreach activities related to Pediatric Cardiovascular Health control number. This information is the campaign, this study seeks to learn SUMMARY: Under the provisions of required to be stated in the 30-day the following: (a) Parents’ awareness of Section 3507(a)(1)(D) of the Paperwork Federal Register Notice. cardiovascular disease risk factors in Reduction Act of 1995, the National Proposed Collection: Describe the children and knowledge of what to do Heart, Lung, and Blood Institute proposed information collection activity for risk reduction, (b) parents’ level of (NHLBI), the National Institutes of as follows. Include: Title: Parental efficacy toward taking action to promote Health has submitted to the Office of Knowledge, Attitudes, and Behaviors cardiovascular health and reduce risk Management and Budget (OMB) a Related to Pediatric Cardiovascular factors, and (c) parents’ behaviors request to review and approve the Health; Type of Information Collection related to cardiovascular health. The information collection listed below. Request: New; Need and Use of findings will provide valuable This proposed information collection Information Collection: Coinciding with information that will enable NHLBI to was previously published in the Federal the release of the Integrated Pediatric identify the gaps in knowledge and Register on Wednesday, July 29, 2009, Cardiovascular Risk Reduction awareness and target specific
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information in communications with Dated: October 30, 2009. information they conduct or sponsor. parents. NHLBI will also be able to Amy Pianalto, ‘‘Collection of information’’ is defined determine parents’ efficacy related to Technical Writer, Office of Communications in 44 U.S.C. 3502(3) and 5 CFR the actions needed to promote their and Legislative Activities, NHLBI, National 1320.3(c) and includes agency requests children’s heart health, allocating Institutes of Health. or requirements that members of the resources for the campaign to provide [FR Doc. E9–27688 Filed 11–17–09; 8:45 am] public submit reports, keep records, or support to overcome perceived barriers; BILLING CODE 4140–01–P provide information to a third party. Frequency of Response: One-time Section 3506(c)(2)(A) of the PRA (44 survey; Affected Public: Individuals or U.S.C. 3506(c)(2)(A)) requires Federal households; and Type of Respondents: DEPARTMENT OF HEALTH AND agencies to provide a 60-day notice in Parents and caregivers of children ages HUMAN SERVICES the Federal Register concerning each 0–7. The annual reporting burden is as proposed collection of information follows: Estimated Number of Food and Drug Administration before submitting the collection to OMB Respondents: 1,175; Estimated Number [Docket No. FDA–2009–N–0535] for approval. To comply with this of Responses per Respondent: 1; requirement, FDA is publishing notice Average Burden Hours Per Response: Agency Information Collection of the proposed collection of .167; and Estimated Total Annual Activities; Proposed Collection; information set forth in this document. Burden Hours Requested: 196.23. There Comment Request; ‘‘Real Time’’ With respect to the following are no Capital Costs, Operating Costs, Surveys of Consumers’ Knowledge, collection of information, FDA invites and/or Maintenance Costs to report. Perceptions, and Reported Behavior comments on these topics: (1) Whether Request for Comments: Written Concerning Foodborne Illness the proposed collection of information comments and/or suggestions from the Outbreaks or Food Recalls is necessary for the proper performance public and affected agencies should of FDA’s functions, including whether address one or more of the following AGENCY: Food and Drug Administration, the information will have practical points: (1) Evaluate whether the HHS. utility; (2) the accuracy of FDA’s proposed collection of information is ACTION: Notice. estimate of the burden of the proposed necessary for the proper performance of collection of information, including the SUMMARY: The Food and Drug the function of the agency, including validity of the methodology and Administration (FDA) is announcing an whether the information will have assumptions used; (3) ways to enhance opportunity for public comment on the practical utility; (2) Evaluate the the quality, utility, and clarity of the proposed collection of certain accuracy of the agency’s estimate of the information to be collected; and (4) information by the agency. Under the burden of the proposed collection of ways to minimize the burden of the Paperwork Reduction Act of 1995 (the information, including the validity of collection of information on PRA), Federal agencies are required to the methodology and assumptions used; respondents, including through the use publish notice in the Federal Register (3) Enhance the quality, utility, and of automated collection techniques, concerning each proposed collection of clarity of the information to be when appropriate, and other forms of information and to allow 60 days for collected; and (4) Minimize the burden information technology. of the collection of information on those public comment in response to the who are to respond, including the use notice. This notice solicits comments on ‘‘Real Time’’ Surveys of Consumers’ of appropriate automated, electronic, ‘‘Real Time’’ surveys of consumers’ Knowledge, Perceptions, and Reported mechanical, or other technological knowledge, perceptions, and beliefs Behavior Concerning Foodborne Illness collection techniques or other forms of concerning foodborne illness outbreaks Outbreaks or Food Recalls—Federal information technology. or food recalls. Food, Drug, and Cosmetic Act/Section Direct Comments to OMB: Written DATES: Submit written or electronic 903(d)(2)(C)—(OMB Control Number comments and/or suggestions regarding comments on the collection of 0910–NEW) the item(s) contained in this notice, information by January 19, 2010. I. Description especially regarding the estimated ADDRESSES: Submit electronic FDA communicates with consumers public burden and associated response comments on the collection of time, should be directed to the: Office about food recalls directly, on its own information to http:// Web site, and through various mass of Management and Budget, Office of www.regulations.gov. Submit written Regulatory Affairs, media channels, such as television and comments on the collection of [email protected] or by newspapers, during a foodborne illness information to the Division of Dockets fax to 202–395–6974, Attention: Desk outbreak or food recall. In these Management (HFA–305), Food and Drug Officer for NIH. To request more communications, FDA typically Administration, 5630 Fishers Lane, rm. information on the proposed project or identifies the implicated food, the 1061, Rockville, MD 20852. All to obtain a copy of the data collection symptoms of the foodborne illness at comments should be identified with the plans and instruments, contact: Amy issue, any subpopulations at elevated docket number found in brackets in the Pianalto, National Heart, Lung, and risk of infection or illness, and heading of this document. Blood Institute, NIH, 31 Center Drive, protective measures individuals can or Building 31A, Room 4A10, Bethesda, FOR FURTHER INFORMATION CONTACT: should take. The purpose of these MD 20892; or call non-toll-free number Denver Presley Jr., Office of Information communications is to provide 301–594–2093 or e-mail request, Management (HFA–710), Food and Drug consumers with information so they can including your address, to Administration, 5600 Fishers Lane, protect themselves from potential health [email protected]. Rockville, MD 20857, 301–796–3793. risks associated with an outbreak or Comments Due Date: Comments SUPPLEMENTARY INFORMATION: Under the food recall. Consumers also get regarding this information collection are PRA (44 U.S.C. 3501–3520), Federal information about an outbreak or recall best assured of having their full effect if agencies must obtain approval from the from other sources, including other received within 30 days of the date of Office of Management and Budget federal and state agencies, industry, this publication. (OMB) for each collection of consumer groups, and the mass media,
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which may or may not relay FDA’s incident and that they are taking outbreak or recall; and (4) how public announcements. appropriate actions. Results from the consumers can protect themselves. FDA Existing data show that many information collection will indicate to plans to conduct the surveys soon after consumers do not take appropriate FDA whether the agency should adjust the onset of an outbreak or recall and protective actions during a foodborne its communications to help consumers whenever the agency suspects that: (1) illness outbreak or food recall (Refs. 1 react appropriately. Messages are not reaching consumers; and 2). For example, 41 percent of U.S. FDA conducts research and and/or (2) consumers do not understand consumers say they have never looked educational and public information the messages; and/or (3) consumers are for any recalled product in their home programs relating to food safety under to not taking appropriate actions in (Ref. 2). Conversely, some consumers its broad statutory authority, set forth in response to the messaging. Collecting overreact to the announcement of a section 903(b)(2) of the Federal Food, information quickly during a foodborne foodborne illness outbreak or food Drug, and Cosmetic Act (21 U.S.C. 393 illness outbreak or food recall is recall. In response to the 2006 fresh, (b)(2), to protect the public health by important because erroneous bagged spinach recall which followed a ensuring that foods are ‘‘safe, perceptions or misinterpreted multistate outbreak of E coli 0157: H7 wholesome, sanitary, and properly information about an outbreak or recall infections (Ref. 3), 18 percent of labeled,’’ and in section 903(d)(2)(C), to can impede consumer adoption of consumers said they stopped buying conduct research relating to foods, recommended protective behaviors. other bagged, fresh produce because of drugs, cosmetics and devices in carrying Criteria for selecting a particular the spinach recall (Ref. 1). Existing out the act. foodborne illness outbreak or food recall research also suggests that many FDA plans to survey U.S. consumers for a survey will include a qualitative consumers may not have correct using a web-based panel of U.S. assessment of the salience of some or all knowledge about products subject to a households to collect information on of the following: the geographical given recall. For example, in a survey consumers’ ‘‘real time’’ knowledge, dispersion of the event, the number of conducted 2 months after the onset of perceptions, beliefs, and self-reported illnesses or deaths associated with it, the 2006 spinach recall, one third of behaviors for up to five foodborne the relative familiarity of the food respondents did not know that, in illness outbreaks or food recalls a year. product, the complexity of consumer addition to bagged spinach, fresh loose Moreover, because the information precaution instructions, and the spinach was part of the recall, while 22 environment during certain foodborne presence of national media focus. percent believed that frozen spinach illness outbreaks or food recalls evolves was subject to the recall (it was not) as new information emerges, the agency The agency will use the survey results (Refs. 1 and 3). In order for FDA to plans to field up to three waves of to help adjust its communication protect the public health during independent surveys per event (i.e., strategies and messages for foodborne foodborne illness outbreaks or food outbreak or recall). The surveys will illness outbreaks or food recalls, when recalls, the agency needs timely query consumers on topics such as: (1) needed. The results will not be used to information collected from consumers The products that are subject to the develop population estimates. as the events unfold to ensure that outbreak or recall; (2) the implicated FDA estimates the burden of this consumers understand the extent of the pathogens; (3) the food vehicle of the collection of information as follows:
TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN1
No. of Annual Frequency Total Annual Hours per Portion of Study Respondents per Response Responses Response Total Hours
Screener 30,000 1 30,000 .0055 165
Pretest 40 1 40 .167 7
Survey 15,000 1 15,000 .167 2,505
Total 2,677 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Approximately 30,000 respondents of it will take a respondent 10 minutes 1. Cuite, C., S. Condry, M. Nucci, and W. a web-based consumer panel will be (0.167 hours) to complete the survey, for Hallman, ‘‘Public Response to the screened, (3 waves (independent a total of 2,505 hours. Thus, the total Contaminated Spinach Recall of surveys) for each of 5 incidents; 2,000 2006,’’Publication number RR–0107–013, estimated annual reporting burden is New Brunswick, New Jersey: Rutgers, the respondents per wave). We estimate that 2,677 hours. FDA’s burden estimate is State University of New Jersey, Food Policy it will take a respondent 20 seconds based on prior experience with Institute, 2007. (0.0055 hours) to complete the screening consumer surveys that are similar to 2. Hallman, W., C. Cuite, and N. Hooker, questions, for a total of 165 hours. We these. ‘‘Consumer Responses to Food Recalls: 2009 will conduct a pretest of the first survey National Survey Report,’’ Publication number with 40 respondents; we estimate that it II. References RR–0109–018, New Brunswick, New Jersey: will take a respondent 10 minutes Rutgers, the State University of New Jersey, (0.167 hours) to complete the pretest, for The following references have been Food Policy Institute, 2009. 3. Acheson, D., ‘‘Outbreak of Escherichia a total of 7 hours. Fifteen thousand placed on display in the Division of Dockets Management (see ADDRESSES) coli 0157 Infections Associated With Fresh (15,000) respondents will complete the Spinach—United States, August-September surveys (3 waves (independent surveys) and may be seen by interested persons 2006,’’ 2007, (http://first.fda.gov/cafdas/ for each of 5 incidents; 1,000 between 9 a.m. and 4 p.m., Monday documents/Acheson_Spinach_Outbreak_ respondents per wave). We estimate that through Friday. 2006_FDA_pres.ppt).
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Dated: November 12, 2009. DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND David Horowitz, HUMAN SERVICES HUMAN SERVICES Assistant Commissioner for Policy. National Institutes of Health [FR Doc. E9–27659 Filed 11–17–09; 8:45 am] Food and Drug Administration BILLING CODE 4160–01–S Government-Owned Inventions; [Docket No. FDA–2009–C–0543] Availability for Licensing DEPARTMENT OF HEALTH AND Sauflon Pharmaceuticals Ltd.; Filing of AGENCY: National Institutes of Health, HUMAN SERVICES Color Additive Petition Public Health Service, HHS. ACTION: Notice. Administration for Children and AGENCY: Food and Drug Administration, Families HHS. SUMMARY: The inventions listed below are owned by an agency of the U.S. Administration on Children, Youth and ACTION: Notice. Government and are available for Families; Notice To Award One licensing in the U.S. in accordance with Expansion Supplement Grant SUMMARY: The Food and Drug 35 U.S.C. 207 to achieve expeditious Administration (FDA) is announcing commercialization of results of AGENCY: Family and Youth Services that Sauflon Pharmaceuticals Ltd. has federally-funded research and Bureau, ACYF, ACF, HHS. filed a petition proposing that the color development. Foreign patent additive regulations be amended to applications are filed on selected ACTION: Notice to award one expansion provide for the safe use of disodium 1- inventions to extend market coverage supplement grant. amino-4-[[4-[(2-bromo-1- for companies and may also be available oxoallyl)amino]-2- for licensing. CFDA Number: 93.592. sulfonatophenyl]amino]-9,10-dihydro- ADDRESSES: Licensing information and Legislative Authority: The Family 9,10-dioxoanthracene-2-sulfonate (CAS copies of the U.S. patent applications Violence Prevention and Services Act, Reg. No. 70209–99–3) as a color additive listed below may be obtained by writing 42 U.S.C. 10401 through 10421, as in contact lenses. to the indicated licensing contact at the extended by the Department of Health Office of Technology Transfer, National and Human Services Appropriations FOR FURTHER INFORMATION CONTACT: Institutes of Health, 6011 Executive Act, 2009, Public Law 111–8. Raphael A. Davy, Center for Food Safety Boulevard, Suite 325, Rockville, Total Amount of Award: $225,000. and Applied Nutrition (HFS–265), Food Maryland 20852–3804; telephone: 301/ and Drug Administration, 5100 Paint 496–7057; fax: 301/402–0220. A signed Project Period: September 30, 2009– Branch Pkwy., College Park, MD 20740– Confidential Disclosure Agreement will September 29, 2010. 3835, 301–436–1272. be required to receive copies of the SUMMARY: This notice announces the patent applications. SUPPLEMENTARY INFORMATION: award of an expansion supplement Under the Federal Food, Drug, and Cosmetic Act A Novel Treatment for Malarial grant to one grantee under the Family Infections and Youth Services Bureau (FYSB)/ (sec. 721(d)(1) (21 U.S.C. 379e(d)(1))), Family Violence Prevention and notice is given that a color additive Description of Invention: The Services Program. The expansion petition (CAP 8C0287) has been filed by inventions described herein are supplement award is made to the Sauflon Pharmaceuticals Ltd., 49–53 antimalarial small molecule inhibitors Pennsylvania Coalition Against York St., Twickenham, Middlesex, TW1 of the plasmodial surface anion channel Domestic Violence, Harrisburg, PA, a 3LP, United Kingdom. The petition (PSAC), an essential nutrient acquisition technical assistance provider, to support proposes to amend the color additive ion channel expressed on human their capacity to provide technical regulations in 21 CFR part 73, subpart erythrocytes infected with malaria support and training to State and local D, Medical Devices to provide for the parasites. These inhibitors were domestic violence advocates and social safe use of disodium 1-amino-4-[[4-[(2- discovered by high-throughput service agencies. These efforts will bromo-1-oxoallyl)amino]-2- screening of chemical libraries and analysis of their ability to kill malaria allow FYSB to support collaborative sulfonatophenyl]amino]-9,10-dihydro- parasites in culture. Two separate work to enhance the capacity of 9,10-dioxoanthracene-2-sulfonate (CAS Temporary Assistance to Needy classes of inhibitors were found to work Reg. No. 70209–99–3) as a color additive synergistically in combination against Families (TANF) and other Federal in contact lenses. programs to provide assistance to PSAC and killed malaria cultures at eligible victims of domestic violence. The agency has determined under 21 markedly lower concentrations than CFR 25.32(l) that this action is of a type separately. These inhibitors have high FOR FURTHER INFORMATION CONTACT: that does not individually or affinity and specificity for PSAC and Marylouise Kelley, Ph.D., Director, cumulatively have a significant effect on have acceptable cytotoxicity profiles. Family Violence Prevention and the human environment. Therefore, Preliminary in vivo testing of these Services Program, 1250 Maryland neither an environmental assessment compounds in a mouse malaria model is Avenue, SW., Suite 8216, Washington, nor an environmental impact statement currently ongoing. DC 20024. Telephone: 202–104–5756 E- is required. Applications: Treatment of malarial mail: [email protected]. infections. Dated: November 10, 2009. Dated: November 10, 2009. Advantages: Novel drug treatment for Laura M. Tarantino, malarial infections; Synergistic effect of Maiso L. Bryant, Director, Office of Food Additive Safety, these compounds on PSAC. Acting Commissioner, Administration on Center for Food Safety and Applied Nutrition. Development Status: In vitro and in Children, Youth and Families. [FR Doc. E9–27629 Filed 11–17–09; 8:45 am] vivo data can be provided upon request. [FR Doc. E9–27667 Filed 11–17–09; 8:45 am] Market: Treatment of malarial BILLING CODE 4160–01–S BILLING CODE 4184–32–P infection.
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Inventor: Sanjay A. Desai (NIAID) ratios of expression for the two (2) This program announcement is subunits were determined for IL–12, IL– subject to the appropriation of funds. Publications 23, and IL–27. This notice is being published early to 1. M Kang, G Lisk, S Hollingworth, Applications: Tumor treatment; Anti- coincide with the recruitment activity of SM Baylor, SA Desai. Malaria parasites viral therapy; Anti-inflammatory the IHS, which competes with other are rapidly killed by dantrolene therapy. Government and private health derivatives specific for the plasmodial Advantages: Increased expression and management organizations to employ surface anion channel. Mol. Pharmacol. stability of in vitro expressed IL–12, IL– qualified health professionals. 2005 Jul;68(1):34–40. 23 and IL–27 cytokines. This program is authorized by Section 2. SA Desai, SM Bezrukov, J Development Status: In vitro data and 108 of the Indian Health Care Zimmerberg. A voltage-dependent data in animal models can be provided Improvement Act (IHCIA) as amended, channel involved in nutrient uptake by upon request. 25 U.S.C. 1601 et seq. The IHS invites red blood cells infected with the malaria Market: Infectious Diseases; Cancer; potential applicants to request an parasite. Nature. 2000 Aug Inflammatory Diseases. application for participation in the LRP. 31;406(6799):1001–1005. Inventors: George N. Pavlakis and Patent Status: International Patent Barbara K. Felber (NCI). II . Award Information Patent Status: International PCT Application No. PCT/US09/50637 (HHS The estimated amount available is Patent Application No. PCT/US09/ Reference No. E–202–2008/0–PCT–02) approximately $17,488,854 to support 043481 filed 11 May 2009 (HHS filed 15 Jul 2009. approximately 391 competing awards Licensing Status: Available for Reference No. E–192–2008/1–PCT–02). Licensing Status: Available for averaging $44,740 per award for a two licensing. year contract. One year contract Licensing Contact: Kevin W. Chang; licensing. Licensing Contact: Kevin W. Chang, continuations will receive priority 301–435–5018; [email protected]. consideration in any award cycle. Collaborative Research Opportunity: Ph.D.; 301–435–5018; [email protected]. Applicants selected for participation in The NIAID Office of Technology the FY 2010 program cycle will be Development is seeking statements of Collaborative Research Opportunity: The Center for Cancer Research, Human expected to begin their service period capability or interest from parties no later than September 30, 2010. interested in collaborative research to Retrovirus Section, is seeking further develop, evaluate, or statements of capability or interest from III. Eligibility Information parties interested in collaborative commercialize antimalarial drugs that 1. Eligible Applicants target PSAC or other parasite-specific research to further develop, evaluate, or transporters. Please contact Dana Hsu at commercialize delivery of cytokines of Pursuant to Section 108(b), to be 301–496–2644 for more information. the IL–12 family in cancer and other eligible to participate in the LRP, an indications. Please contact John D. individual must: Optimized Expression of IL–12 Hewes, Ph.D. at 301–435–3121 or (1) (A) Be enrolled— Cytokine Family [email protected] for more (i) In a course of study or program in Description of Invention: The IL–12 information. an accredited institution, as determined family of cytokines (IL–12, IL–23, and Dated: November 9, 2009. by the Secretary, within any State and IL–27) has an important role in Richard U. Rodriguez, be scheduled to complete such course of inflammation and autoimmune diseases. Director, Division of Technology Development study in the same year such individual IL–12 is produced by macrophages and and Transfer, Office of Technology Transfer, applies to participate in such program; dendritic cells in response to certain National Institutes of Health. or bacterial and parasitic infections and is [FR Doc. E9–27633 Filed 11–17–09; 8:45 am] (ii) In an approved graduate training a powerful inducer of IFN-gamma BILLING CODE 4140–01–P program in a health profession; or production. IL–23 is proposed to (B) Have a degree in a health stimulate a subset of T cells to produce profession and a license to practice in IL–17, which in turn induce the DEPARTMENT OF HEALTH AND a state; and production of proinflammatory HUMAN SERVICES (2) (A) Be eligible for, or hold an cytokines that lead to a protective appointment as a Commissioned Officer response during infection. IL–27 Indian Health Service in the Regular or Reserve Corps of the appears to have duel functions as an Public Health Service (PHS); or initiator of TH1-type (cellular Loan Repayment Program for (B) Be eligible for selection for service immunity) immune responses and as an Repayment of Health Professions in the Regular or Reserve Corps of the attenuator of immune/inflammatory Educational Loans PHS; or responses. Announcement Type: Initial. (C) Meet the professional standards The present inventions provide CFDA Number: 93.164. for civil service employment in the IHS; methods for improved expression of Key Dates: January 15, 2010 first or multimeric proteins by engineering award cycle deadline date, September (D) Be employed in an Indian health different ratios of the subunit expression 30, 2010 entry on duty deadline date. program without service obligation; and units in a cell or upon expression from (E) Submit to the Secretary an a multi-promoter plasmid having I. Funding Opportunity Description application for a contract to the LRP. different strength promoters. The The Indian Health Service (IHS) The Secretary must approve the contract inventors have improved the levels and estimated budget request for Fiscal Year before the disbursement of loan efficiency of expression of the IL–12 (FY) 2010 includes $17,488,854 for the repayments can be made to the family of cytokines, which includes IL– IHS Loan Repayment Program (LRP) for participant. Participants will be 12, IL–23, and IL–27, by adjusting the health professional educational loans required to fulfill their contract service transcription and translation of the (undergraduate and graduate) in return agreements through full-time clinical alpha and beta subunits that comprise for full-time clinical service in Indian practice at an Indian health program site the heterodimeric proteins. Optimal health programs. determined by the Secretary. Loan
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repayment sites are characterized by well as upon the needs of American 2. Content and Form of Application physical, cultural, and professional Indians and Alaska Natives. Submission isolation, and have histories of frequent (a) Medicine: Allopathic and Applications must be submitted on staff turnover. All Indian health Osteopathic. the form entitled ‘‘Application for the program sites are annually prioritized (b) Nurse: Associate, B.S., and M.S. Indian Health Service Loan Repayment within the Agency by discipline, based Degree. Program,’’ identified with the Office of on need or vacancy. (c) Clinical Psychology: Ph.D. only. Management and Budget approval Any individual who owes an (d) Social Work: Masters level only. number of OMB #0917–0014, Expiration obligation for health professional (e) Chemical Dependency Counseling: Date 02/29/2012. service to the Federal Government, a Baccalaureate and Masters level. State, or other entity is not eligible for (f) Dentistry. 3. Submission Dates and Times the LRP unless the obligation will be (g) Dental Hygiene. Completed applications may be completely satisfied before they begin (h) Pharmacy: B.S., Pharm.D. submitted to the IHS Loan Repayment service under this program. (i) Optometry: O.D. Program, 801 Thompson Avenue, Suite Section 108 of the IHCIA, as amended (j) Physician Assistant, Certified. 120, Rockville, Maryland 20852. by Public Laws 100–713 and 102–573, (k) Advanced Practice Nurses: Nurse Applications for the FY 2010 LRP will authorizes the IHS LRP and provides in Practitioner, Certified Nurse Midwife, be accepted and evaluated monthly pertinent part as follows: Registered Nurse Anesthetist (Priority beginning January 15, 2010, and will ‘‘(a)(1) The Secretary, acting through the consideration will be given to continue to be accepted each month Service, shall establish a program to be Registered Nurse Anesthetists.). thereafter until all funds are exhausted known as the Indian Health Service Loan for FY 2010. Subsequent monthly Repayment Program (hereinafter referred to (l) Podiatry: D.P.M. (m) Physical Rehabilitation Services: deadline dates are scheduled for Friday as the ‘‘Loan Repayment Program’’) in order of the second full week of each month. to assure an adequate supply of trained Physical Therapy, Occupational health professionals necessary to maintain Therapy, Speech-Language Pathology, Applications shall be considered as accreditation of, and provide health care and Audiology: M.S. and D.P.T. meeting the deadline if they are either: services to Indians through, Indian health (n) Diagnostic Radiology Technology: (a) Received on or before the deadline programs.’’ Certificate, Associate, and B.S. date; or (b) Sent on or before the deadline Section 4(n) of the IHCIA, as amended (o) Medical Technology: Associate, date. (Applicants should request a by the Indian Health Care Improvement and B.S. legibly dated U.S. Postal Service Technical Corrections Act of 1996, (p) Public Health Nutritionist/ postmark or obtain a legibly dated Public Law 104–313, provides that: Registered Dietitian. receipt from a commercial carrier or (q) Engineering (Environmental): B.S. ‘‘Health Profession’’ means allopathic U.S. Postal Service. Private metered (Engineers must provide environmental medicine, family medicine, internal postmarks are not acceptable as proof of engineering services to be eligible.). medicine, pediatrics, geriatric medicine, timely mailing.). obstetrics and gynecology, podiatric (r) Environmental Health (Sanitarian): Applications received after the medicine, nursing, public health nursing, B.S. dentistry, psychiatry, osteopathy, optometry, monthly closing date will be held for (s) Health Records: R.H.I.T. and consideration in the next monthly pharmacy, psychology, public health, social R.H.I.A. work, marriage and family therapy, funding cycle. Applicants who do not chiropractic medicine, environmental health (t) Respiratory Therapy. receive funding by September 30, 2010, and engineering, and allied health (u) Ultrasonography. will be notified in writing. profession, or any other health profession. 2. Cost Sharing or Matching 4. Intergovernmental Review For the purposes of this program, the Not applicable. term ‘‘Indian health program’’ is defined This program is not subject to review in Section 108(a)(2)(A), as follows: 3. Other Requirements under Executive Order 12372. (A) The term ‘‘Indian health program’’ Interested individuals are reminded 5. Funding Restrictions means any health program or facility that the list of eligible health and allied Not applicable. funded, in whole or in part, by the health professions is effective for Service for the benefit of Indians and applicants for FY 2010. These priorities 6. Other Submission Requirements administered— will remain in effect until superseded. All applicants must sign and submit (i) Directly by the Service; to the Secretary, a written contract (ii) By any Indian Tribe or Tribal or IV. Application and Submission agreeing to accept repayment of Indian organization pursuant to a Information educational loans and to serve for the contract under— 1. Address To Request Application (I) The Indian Self-Determination Act, applicable period of obligated service in Package or a priority site as determined by the (II) Section 23 of the Act of April 30, Application materials may be Secretary, and submit a signed affidavit 1908, (25 U.S.C. 47), popularly known obtained online at http:// attesting to the fact that they have been as the Buy Indian Act; or www.loanrepayment.ihs.gov/ or by informed of the relative merits of the (iii) By an urban Indian organization calling or writing to the address below. U.S. PHS Commissioned Corps and the pursuant to Title V of this act.’’ In addition, completed applications Civil Service as employment options. Section 108 of the IHCIA, as amended should be returned to: IHS Loan V. Application Review Information by Public Laws 100–713 and 102–573, Repayment Program, 801 Thompson authorizes the IHS to determine specific Avenue, Suite 120, Rockville, Maryland 1. Criteria health professions for which IHS LRP 20852, Telephone: 301/443–3396 The IHS has identified the positions contracts will be awarded. The list of [between 8 a.m. and 5 p.m. (EST) in each Indian health program for which priority health professions that follows Monday through Friday, except Federal there is a need or vacancy and ranked is based upon the needs of the IHS as holidays]. those positions in order of priority by
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developing discipline-specific 2. Administrative and National Policy to exceed $35,000 a year plus tax prioritized lists of sites. Ranking criteria Requirements assistance. All additional funding must for these sites may include the Applicants may sign contractual be made in accordance with the priority following: agreements with the Secretary for two system outlined below. Health (a) Historically critical shortages years. The IHS may repay all, or a professions given priority for selection caused by frequent staff turnover; portion of the applicant’s health above the $20,000 threshold are those (b) Current unmatched vacancies in a profession educational loans identified as meeting the criteria in 25 health profession discipline; (undergraduate and graduate) for tuition U.S.C. 1616a(g)(2)(A) which provides (c) Projected vacancies in a health expenses and reasonable educational that the Secretary shall consider the profession discipline; extent to which each such (d) Ensuring that the staffing needs of and living expenses in amounts up to $20,000 per year for each year of determination: Indian health programs administered by contracted service. Payments will be (i) Affects the ability of the Secretary an Indian Tribe or Tribal health made annually to the participant for the to maximize the number of contracts organization receive consideration on an purpose of repaying his/her outstanding that can be provided under the LRP equal basis with programs that are health profession educational loans. from the amounts appropriated for such administered directly by the Service; Payment of health profession education contracts; and (ii) Provides an incentive to serve in loans will be made to the participant (e) Giving priority to vacancies in Indian health programs with the greatest within 120 days, from the date the Indian health programs that have a need shortages of health professionals; and contract becomes effective. The effective for health professionals to provide (iii) Provides an incentive with date of the contract is calculated from health care services as a result of respect to the health professional the date it is signed by the Secretary or individuals having breached LRP involved remaining in an Indian health his/her delegate, or the IHS, Tribal, contracts entered into under this program with such a health professional urban, or ABuy-Indian@ health center section. shortage, and continuing to provide Consistent with this priority ranking, entry-on-duty date, whichever is more primary health services, after the in determining applications to be recent. completion of the period of obligated In addition to the loan payment, approved and contracts to accept, the service under the LRP. participants are provided tax assistance IHS will give priority to applications Contracts may be awarded to those payments in an amount not less than 20 made by American Indians and Alaska who are available for service no later percent and not more than 39 percent of Natives and to individuals recruited than September 30, 2010, and must be the participant’s total amount of loan in compliance with any limits in the through the efforts of Indian Tribes or repayments made for the taxable year Tribal or Indian organizations. appropriation and Section 108 of the involved. The loan repayments and the IHCIA not to exceed the amount 2. Review and Selection Process tax assistance payments are taxable authorized in the IHS appropriation (up Loan repayment awards will be made income and will be reported to the to $32,000,000 for FY 2010). In order to only to those individuals serving at Internal Revenue Service (IRS). The tax ensure compliance with the statutes, facilities which have a site score of 70 assistance payment will be paid to the Area Offices or Service Units providing IRS directly on the participant’s behalf. or above during the first and second additional funding under this section LRP award recipients should be aware quarters and the first month of the third are responsible for notifying the LRP of that the IRS may place them in a higher quarter of FY 2010, if funding is such payments before funding is offered tax bracket than they would otherwise available. to the LRP participant. One or all of the following factors may have been prior to their award. Should an IHS Area Office contribute be applicable to an applicant, and the 3. Contract Extensions to the LRP, those funds will be used for applicant who has the most of these Any individual who enters this only those sites located in that Area. factors, all other criteria being equal, program and satisfactorily completes his Those sites will retain their relative will be selected. or her obligated period of service may ranking from the national site-ranking (a) An applicant’s length of current apply to extend his/her contract on a list. For example, the Albuquerque Area employment in the IHS, Tribal, or urban year-by-year basis, as determined by the Office identifies supplemental monies program. IHS. Participants extending their for dentists. Only the dental positions (b) Availability for service earlier than contracts may receive up to the within the Albuquerque Area will be other applicants (first come, first maximum amount of $20,000 per year funded with the supplemental monies served). consistent with the national ranking and (c) Date the individual’s application plus an additional 20 percent for Federal withholding. site index within that Area. was received. Should an IHS Service Unit VII. Agency Contacts 3. Anticipated Announcement and contribute to the LRP, those funds will Award Dates Please address inquiries to Ms. be used for only those sites located in Jacqueline K. Santiago, Chief, IHS Loan that Service Unit. Those sites will retain Not applicable. Repayment Program, 801 Thompson their relative ranking from the national VI. Award Administration Information Avenue, Suite 120, Rockville, Maryland site-ranking list. For example, Chinle 20852, Telephone: 301/443–3396 Service Unit identifies supplemental 1. Award Notices [between 8 a.m. and 5 p.m. (EST) monies for pharmacists. The Chinle Notice of awards will be mailed on Monday through Friday, except Federal Service Unit consists of two facilities, the last working day of each month. holidays]. namely the Chinle Comprehensive Once the applicant is approved for Health Care Facility and the Tsaile PHS participation in the LRP, the applicant VIII. Other Information Indian Health Center. The national will receive confirmation of his/her loan IHS Area Offices and Service Units ranking will be used for the Chinle repayment award and the duty site at that are financially able are authorized Comprehensive Health Care Facility which he/she will serve his/her loan to provide additional funding to make (Score = 44) and the Tsaile PHS Indian repayment obligation. awards to applicants in the LRP, but not Health Center (Score = 46). With a score
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of 46, the Tsaile PHS Indian Health panel; (2) a discussion of the Advisory DEPARTMENT OF HEALTH AND Center would receive priority over the Committee’s final draft of the report on the HUMAN SERVICES Chinle Comprehensive Health Care use and storage of newborn screening Facility. Residual Blood Spots; (3) an update on the National Institutes of Health development of the Newborn Screening Dated: November 6, 2009. Information Clearinghouse; and (4) National Institute of Biomedical Yvette Roubideaux, presentations on the continued work and Imaging and Bioengineering; Notice of Director, Indian Health Service. reports of the Advisory Committee’s Meeting [FR Doc. E9–27721 Filed 11–17–09; 8:45 am] subcommittees on laboratory standards and Pursuant to section 10(d) of the BILLING CODE 4165–16–P procedures, follow-up and treatment, and Federal Advisory Committee Act, as education and training. amended (5 U.S.C. App.), notice is Proposed Agenda items are subject to hereby given of a meeting of the DEPARTMENT OF HEALTH AND change as priorities dictate. You can locate National Advisory Council for HUMAN SERVICES the Agenda, Committee Roster and Charter, presentations, and meeting materials at the Biomedical Imaging and Bioengineering. The meeting will be open to the Health Resources and Services home page of the Advisory Committee’s Web public as indicated below, with Administration site at http://www.hrsa.gov/ attendance limited to space available. heritabledisorderscommittee/. Advisory Committee on Heritable Web cast: The meeting will be Web cast. Individuals who plan to attend and Disorders in Newborns and Children; Information on how to access the Web cast need special assistance, such as sign Notice of Meeting will be available one week prior to the language interpretation or other reasonable accommodations, should In accordance with section 10(a)(2) of meeting, January 14, 2010, by clicking on the notify the Contact Person listed below the Federal Advisory Committee Act meeting date link at http:// events.SignUp4.com/ACHDNC0110. in advance of the meeting. (Pub. L. 92–463), notice is hereby given The meeting will be closed to the of the following meeting: Public Comments: Members of the public can present oral comments during the public public in accordance with the Name: Secretary’s Advisory Committee on comment periods of the meeting, which are provisions set forth in sections Heritable Disorders in Newborns and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Children. scheduled for both days of the meeting. Those individuals who want to make a as amended. The grant applications Dates and Times: January 21, 2010, 8:30 and/or contract proposals and the a.m. to 5 p.m. comment are requested to register online by January 22, 2010, 8:30 a.m. to 3 p.m. Tuesday, January 19, 2010 at http:// discussions could disclose confidential Place: Washington Marriott at Metro events.SignUp4.com/ACHDNC0110. Requests trade secrets or commercial property Center, 775 12th Street, NW., Washington, will contain the name, address, telephone such as patentable material, and DC 20005. number, and any professional or business personal information concerning Status: The meeting will be open to the affiliation of the person desiring to make an individuals associated with the grant public with attendance limited to space oral presentation. Groups having similar applications and/or contract proposals, availability. Participants are asked to register interests are requested to combine their the disclosure of which would for the meeting by going to the registration comments and present them through a single constitute a clearly unwarranted Web site at http://events.SignUp4.com/ invasion of personal privacy. ACHDNC0110. The registration deadline is representative. The list of public comment Tuesday, January 19, 2010. Individuals who participants will be posted on the Web site. Name of Committee: National Advisory need special assistance, such as sign Written comments should be e-mailed via e- Council for Biomedical Imaging and language interpretation or other reasonable mail no later than Tuesday, January 19, 2010 Bioengineering; NACBIB, January, 2010. accommodations should indicate their needs for consideration. Comments should be Date: December 11, 2009. on the registration Web site. The deadline for submitted to Feven Habteab, Meetings Open: 9 a.m. to 1 p.m. special accommodation requests is Friday, Coordinator, Conference and Meetings Agenda: Report from the Institute Director, January 15, 2010. If there are technical Management, Altarum Institute, 1200 18th other Institute Staff and presentations of working group reports. problems gaining access to the Web site, Street, NW., Suite 700, Washington, DC Place: Bethesda Marriott Suites, 6711 please contact Feven Habteab, Meetings 20036, telephone: 202 828–5100; fax: 202 Coordinator at [email protected]. Democracy Boulevard, Independence Room 785–3083, or e-mail: Purpose: The Secretary’s Advisory (2nd Level), Bethesda, MD 20817. Committee on Heritable Disorders in [email protected]. Closed: 1 p.m. to 3:30 p.m. Newborns and Children (Advisory Contact Person: Anyone interested in Agenda: To review and evaluate grant Committee) was established to advise and obtaining other relevant information should applications and/or proposals. guide the Secretary regarding the most write or contact Alaina M. Harris, Maternal Place: Bethesda Marriott Suites, 6711 appropriate application of universal newborn and Child Health Bureau, Health Resources Democracy Boulevard, Independence Room screening tests, technologies, policies, and Services Administration, Room 18A–19, (2nd Level), Bethesda, MD 20817. guidelines and programs for effectively Parklawn Building, 5600 Fishers Lane, Contact Person: Anthony Demsey, PhD, reducing morbidity and mortality in Rockville, Maryland 20857, Telephone (301) Director, National Institute of Biomedical Imaging and Bioengineering, 6701 newborns and children having or at risk for 443–0721, [email protected]. More Democracy Boulevard, Room 241, Bethesda, heritable disorders. The Advisory Committee information on the Advisory Committee is also provides advice and recommendations MD 20892. available at http://mchb.hrsa.gov/ concerning the grants and projects authorized Any interested person may file written under the Public Health Service Act, 42 heritabledisorderscommittee. comments with the committee by forwarding U.S.C. 300b-10, (Heritable Disorders Dated: November 12, 2009. the statement to the Contact Person listed on Program) as amended in the Newborn Alexandra Huttinger, this notice. The statement should include the Screening Saves Lives Act of 2008. name, address, telephone number and when Agenda: The meeting will include: (1) A Director, Division of Policy Review and applicable, the business or professional presentation of the External Review Coordination. affiliation of the interested person. Workgroup’s preliminary report on the [FR Doc. E9–27660 Filed 11–17–09; 8:45 am] Information is also available on the nomination of Alpha-Thalassemia BILLING CODE 4165–15–P Institute’s/Center’s home page: http:// (Hemoglobin H) disease to the Advisory www.nibib1.nih.gov/about/NACBIB/ Committee’s uniform newborn screening NACBIB.htm, where an agenda and any
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additional information for the meeting will DEPARTMENT OF HEALTH AND The meetings will be closed to the be posted when available. HUMAN SERVICES public in accordance with the Dated: November 12, 2009. provisions set forth in sections National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Jennifer Spaeth, as amended. The grant applications and Director, Office of Federal Advisory Eunice Kennedy Shriver National the discussions could disclose Committee Policy. Institute of Child Health & Human confidential trade secrets or commercial [FR Doc. E9–27713 Filed 11–17–09; 8:45 am] Development; Notice of Closed property such as patentable material, BILLING CODE 4140–01–P Meeting and personal information concerning Pursuant to section 10(d) of the individuals associated with the grant Federal Advisory Committee Act, as applications, the disclosure of which DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted HUMAN SERVICES hereby given of the following meeting. invasion of personal privacy. The meeting will be closed to the National Institutes of Health Name of Committee: National Center for public in accordance with the Research Resources Special Emphasis Panel; National Institute of Dental & provisions set forth in sections ARRA STRB DEC. MTG.–1. Date: December 7–11, 2009. Craniofacial Research; Notice of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and Time: 8 a.m. to 5 p.m. Closed Meeting the discussions could disclose Agenda: To review and evaluate grant confidential trade secrets or commercial applications. Pursuant to section 10(d) of the property such as patentable material, Place: National Institutes of Health, One Federal Advisory Committee Act, as Democracy Plaza, 6701 Democracy and personal information concerning amended (5 U.S.C. App.), notice is Boulevard, Bethesda, MD 20892 (Telephone individuals associated with the grant hereby given of the following meeting. Conference Call). applications, the disclosure of which Contact Person: Barbara J. Nelson, PhD, The meeting will be closed to the would constitute a clearly unwarranted Scientific Review Officer, Office of Review, public in accordance with the invasion of personal privacy. National Center for Research Resources, 6701 provisions set forth in sections Name of Committee: National Institute of Democracy Blvd. Room 1080, 1 Democracy 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Child Health and Human Development Plaza, Bethesda, MD 20892, 301–435–0806, as amended. The grant applications and Special Emphasis Panel, Functions and [email protected]. the discussions could disclose Development of the Mirror Neuron System. Name of Committee: National Center for confidential trade secrets or commercial Date: December 8, 2009. Research Resources Special Emphasis Panel; Time: 1 p.m. to 4:30 p.m. property such as patentable material, ARRA STRB DEC. MTG.–2. Agenda: To review and evaluate grant Date: December 7–11, 2009. and personal information concerning applications. Time: 8 a.m. to 5 p.m. individuals associated with the grant Place: National Institutes of Health, 6100 Agenda: To review and evaluate grant applications, the disclosure of which Executive Blvd., Room 5B01, Bethesda, MD applications. would constitute a clearly unwarranted (Telephone Conference Call). Place: National Institutes of Health, invasion of personal privacy. Contact Person: Marita R. Hopmann, PhD, Bethesda, MD (Telephone Conference Call). Scientific Review Officer, Division of Contact Person: Barbara J. Nelson, PhD, Name of Committee: National Institute of Scientific Review Eunice Kennedy Shriver Scientific Review Officer, Office of Review, Dental and Craniofacial Research Special National Institute of Child Health and National Center for Research Resources, 6701 Emphasis Panel; Review PAR–07–332 T32. Human Development, NIH, 6100 Building, Democracy Blvd., Room 1080, 1 Democracy Date: January 13, 2010. Room 5B01, Bethesda, MD 20892, (301) 435– Plaza, Bethesda, MD 20892, 301–435–0806, 6911, [email protected]. Time: 12 p.m. to 1 p.m. [email protected]. Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance Name of Committee: National Center for Program Nos. 93.864, Population Research; applications. Research Resources Special Emphasis Panel; 93.865, Research for Mothers and Children; Place: National Institutes of Health, 6701 ARRA STRB DEC. MTG.–3. 93.929, Center for Medical Rehabilitation Date: December 7–11, 2009. Rockledge Drive, Bethesda, MD 20892 Research; 93.209, Contraception and (Telephone Conference Call). Time: 8 a.m. to 5 p.m. Infertility Loan Repayment Program, National Agenda: To review and evaluate grant Contact Person: Mary Kelly, Scientific Institutes of Health, HHS) applications. Review Officer, Scientific Review Branch, Dated: November 12, 2009. Place: National Institutes of Health, National Inst of Dental & Craniofacial Jennifer Spaeth, Bethesda, MD (Telephone Conference Call). Research, NIH 6701 Democracy Blvd., room Contact Person: Carol Lambert, PhD, 672, MSC 4878, Bethesda, MD 20892–4878, Director, Office of Federal Advisory Committee Policy. Scientific Review Officer, Office of Review, 301–594–4809, [email protected]. National Center for Research Resources, 6701 [FR Doc. E9–27711 Filed 11–17–09; 8:45 am] (Catalogue of Federal Domestic Assistance Democracy Blvd., 1 Democracy Plaza, Room BILLING CODE 4140–01–P Program Nos. 93.121, Oral Diseases and 1076, Bethesda, MD 20892, 301–435–0814, Disorders Research, National Institutes of [email protected]. Health, HHS) Name of Committee: National Center for DEPARTMENT OF HEALTH AND Research Resources Special Emphasis Panel; Dated: November 12, 2009. HUMAN SERVICES ARRA STRB DEC. MTG.–4. Jennifer Spaeth, Date: December 7–11, 2009. National Institutes of Health Time: 8 a.m. to 5 p.m. Director, Office of Federal Advisory Agenda: To review and evaluate grant Committee Policy. National Center for Research applications. [FR Doc. E9–27712 Filed 11–17–09; 8:45 am] Resources; Notice of Closed Meetings Place: National Institutes of Health, BILLING CODE 4140–01–P Bethesda, MD (Telephone Conference Call). Pursuant to section 10(d) of the Contact Person: Carol Lambert, PhD, Federal Advisory Committee Act, as Scientific Review Officer, Office of Review, amended (5 U.S.C. App.), notice is National Center for Research Resources, 6701 hereby given of the following meetings. Democracy Blvd., 1 Democracy Plaza, Room
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1076, Bethesda, MD 20892, 301–435–0814, Boulevard, Bethesda, MD 20892 (Telephone and Hematology Research, National Institutes [email protected]. Conference Call). of Health, HHS) Contact Person: Robert Wellner, PhD, (Catalogue of Federal Domestic Assistance Dated: November 12, 2009. Program Nos. 93.306, Comparative Medicine; Scientific Review Officer, Review Branch, 93.333, Clinical Research; 93.371, Biomedical DEA, NIDDK, National Institutes of Health, Jennifer Spaeth, Technology; 93.389, Research Infrastructure, Room 757, 6707 Democracy Boulevard, Director, Office of Federal Advisory 93.306, 93.333; 93.702, ARRA Related Bethesda, MD 20892–5452, (301) 594–4721, Committee Policy. [email protected]. Construction Awards., National Institutes of [FR Doc. E9–27708 Filed 11–17–09; 8:45 am] Health, HHS) (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, BILLING CODE 4140–01–P Dated: November 12, 2009. Endocrinology and Metabolic Research; Jennifer Spaeth, 93.848, Digestive Diseases and Nutrition Director, Office of Federal Advisory Research; 93.849, Kidney Diseases, Urology DEPARTMENT OF HEALTH AND Committee Policy. and Hematology Research, National Institutes HUMAN SERVICES [FR Doc. E9–27710 Filed 11–17–09; 8:45 am] of Health, HHS) BILLING CODE 4140–01–P Dated: November 12, 2009. National Institutes of Health Jennifer Spaeth, National Center for Complementary & Director, Office of Federal Advisory DEPARTMENT OF HEALTH AND Committee Policy. Alternative Medicine; Notice of Closed Meeting HUMAN SERVICES [FR Doc. E9–27709 Filed 11–17–09; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P Pursuant to section 10(d) of the Federal Advisory Committee Act, as National Institute of Diabetes and DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is Digestive and Kidney Diseases; Notice hereby given of the following meeting. of Closed Meetings HUMAN SERVICES The meeting will be closed to the National Institutes of Health Pursuant to section 10(d) of the public in accordance with the Federal Advisory Committee Act, as National Institute of Diabetes and provisions set forth in sections amended (5 U.S.C. App.), notice is Digestive and Kidney Diseases; Notice 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., hereby given of the following meetings. of Closed Meeting as amended. The grant applications and The meetings will be closed to the the discussions could disclose public in accordance with the Pursuant to section 10(d) of the confidential trade secrets or commercial provisions set forth in sections Federal Advisory Committee Act, as property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., amended (5 U.S.C. App.), notice is and personal information concerning as amended. The grant applications and hereby given of the following meeting. individuals associated with the grant the discussions could disclose The meeting will be closed to the applications, the disclosure of which public in accordance with the confidential trade secrets or commercial would constitute a clearly unwarranted provisions set forth in sections property such as patentable material, invasion of personal privacy. and personal information concerning 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: National Center for individuals associated with the grant as amended. The grant applications and Complementary and Alternative Medicine applications, the disclosure of which the discussions could disclose confidential trade secrets or commercial Special Emphasis Panel; Omics and Variable would constitute a clearly unwarranted Responses to CAM (R21, R01). invasion of personal privacy. property such as patentable material, and personal information concerning Date: December 15, 2009. Name of Committee: National Institute of individuals associated with the grant Time: 12 p.m. to 2 p.m. Diabetes and Digestive and Kidney Diseases applications, the disclosure of which Agenda: To review and evaluate grant Special Emphasis Panel; DEM Training Grant would constitute a clearly unwarranted applications. Conflict Review. invasion of personal privacy. Place: National Institutes of Health, Two Date: December 16, 2009. Democracy Plaza, 6707 Democracy Time: 1 p.m. to 5 p.m. Name of Committee: National Institute of Boulevard, Bethesda, MD 20892 (Telephone Agenda: To review and evaluate grant Diabetes and Digestive and Kidney Diseases Conference Call). applications. Special Emphasis Panel; CRRT Effects on Place: National Institutes of Health, Two Pharmacokinetics in Critically Ill Patients. Contact Person: Martina Schmidt, PhD, Democracy Plaza, 6707 Democracy Date: December 16, 2009. Scientific Review Officer, Office of Scientific Boulevard, Bethesda, MD 20892 (Telephone Time: 3 p.m. to 3:45 p.m. Review, National Center for Complementary Conference Call). Agenda: To review and evaluate grant & Alternative Medicine, NIH, 6707 Contact Person: Robert Wellner, PhD, applications. Democracy Blvd., Suite 401, Bethesda, MD Scientific Review Officer, Review Branch, Place: National Institutes of Health, Two 20892, 301–594–3456, DEA, NIDDK, National Institutes of Health, Democracy Plaza, 6707 Democracy [email protected]. Room 757, 6707 Democracy Boulevard, Boulevard, Bethesda, MD 20892 (Telephone (Catalogue of Federal Domestic Assistance Bethesda, MD 20892–5452, (301) 594–4721, Conference Call). [email protected]. Contact Person: Lakshmanan Sankaran, Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, Name of Committee: National Institute of PhD, Scientific Review Officer, Review Diabetes and Digestive and Kidney Diseases Branch, DEA, NIDDK, National Institutes of National Institutes of Health, HHS) Special Emphasis Panel; R24 Seed Health, Room 755, 6707 Democracy Dated: November 9, 2009. Boulevard, Bethesda, MD 20892–5452, (301) Application Review. Jennifer Spaeth, Date: December 17, 2009. 594–7799, [email protected]. Time: 1 p.m. to 3 p.m. (Catalogue of Federal Domestic Assistance Director, Office of Federal Advisory Agenda: To review and evaluate grant Program Nos. 93.847, Diabetes, Committee Policy. applications. Endocrinology and Metabolic Research; [FR Doc. E9–27707 Filed 11–17–09; 8:45 am] Place: National Institutes of Health, Two 93.848, Digestive Diseases and Nutrition BILLING CODE 4140–01–P Democracy Plaza, 6707 Democracy Research; 93.849, Kidney Diseases, Urology
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DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND 93.333, Clinical Research, 93.306, 93.333, HUMAN SERVICES HUMAN SERVICES 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National National Institutes of Health National Institutes of Health Institutes of Health, HHS) Dated: November 12, 2009. National Institute of Neurological Center for Scientific Review; Notice of Jennifer Spaeth, Disorders and Stroke; Notice of Closed Meetings Director, Office of Federal Advisory Meeting Pursuant to section 10(d) of the Committee Policy. Federal Advisory Committee Act, as [FR Doc. E9–27705 Filed 11–17–09; 8:45 am] Pursuant to section 10(a) of the amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P Federal Advisory Committee Act, as hereby given of the following meetings. amended (5 U.S.C. App.), notice is The meetings will be closed to the hereby given of a meeting of the public in accordance with the DEPARTMENT OF HEALTH AND Muscular Dystrophy Coordinating provisions set forth in sections HUMAN SERVICES Committee (MDCC). 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Centers for Disease Control and as amended. The grant applications and The meeting will be open to the Prevention public, with attendance limited to space the discussions could disclose available. Individuals who plan to confidential trade secrets or commercial Board of Scientific Counselors, property such as patentable material, attend and need special assistance, such National Institute for Occupational and personal information concerning as sign language interpretation or other Safety and Health (BSC, NIOSH) individuals associated with the grant reasonable accommodations, should applications, the disclosure of which In accordance with section 10(a)(2) of inform the Contact Person listed below would constitute a clearly unwarranted the Federal Advisory Committee Act in advance of the meeting. invasion of personal privacy. (Pub. L. 92–463), the Centers for Disease Name of Committee: Muscular Dystrophy Name of Committee: Center for Scientific Control and Prevention (CDC) Coordinating Committee. Review Special Emphasis Panel; Member announces the following meeting for the Date: November 30, 2009. Conflict Applications; CMBK and UKGD. aforementioned committee: Time: 8 a.m. to 3:30 p.m. Date: December 2, 2009. Time and Date: 8:30 a.m.–3:45 p.m., Agenda: The 2009 meeting of the MDCC Time: 2 p.m. to 5 p.m. December 2, 2009. will focus on Federal funding for muscular Agenda: To review and evaluate grant Place: Holiday Inn Capitol, 550 C Street, dystrophy, activities of the Paul Wellstone applications. SW., Washington, DC 20024. Place: National Institutes of Health, 6701 Cooperative Muscular Dystrophy Research Status: Open to the public, limited only by Rockledge Drive, Bethesda, MD 20892 the space available. The meeting room Centers, plans to review the Action Plan for (Telephone Conference Call). the Muscular Dystrophies, and activities of accommodates approximately 50 people. Contact Person: Najma Begum, PhD, Teleconference available toll-free; please dial MDCC member agencies and organizations. Scientific Review Officer, Center for (866) 423–5960, Participant Pass Code An agenda will be posted prior to the Scientific Review, National Institutes of 2988491. meeting on the MDCC Web site: http:// Health, 6701 Rockledge Drive, Room 2186, Purpose: The Secretary, the Assistant www.ninds.nih.gov/find_people/groups/ MSC 7818, Bethesda, MD 20892, 301–435– Secretary for Health, and by delegation the mdcc/index.htm. 1243, [email protected]. Director, Centers for Disease Control and Place: Hyatt Regency Bethesda, One Name of Committee: Center for Scientific Prevention, are authorized under Sections Bethesda Metro Center, Bethesda, MD 20814. Review Special Emphasis Panel; RFA–OD– 301 and 308 of the Public Health Service Act Contact Person: John D. Porter, PhD, 09–007: ARRA AREA Grants Panel 09. to conduct directly or by grants or contracts, Date: December 7, 2009. Executive Secretary, Muscular Dystrophy research, experiments, and demonstrations Time: 8 a.m. to 6 p.m. relating to occupational safety and health and Coordinating Committee, National Institute Agenda: To review and evaluate grant to mine health. The Board of Scientific of Neurological Disorders and Stroke, NIH, applications. Counselors shall provide guidance to the 6001 Executive Boulevard, NSC 2172, Place: Palomar Hotel, 2121 P Street, NW., Director, National Institute for Occupational Bethesda, MD 20892, (301) 496–5739, Washington, DC 20037. Safety and Health on research and prevention [email protected]. Contact Person: Carole L. Jelsema, PhD, programs. Specifically, the Board shall Any interested person may file written Chief and Scientific Review Officer, Center provide guidance on the Institute’s research comments with the committee by forwarding for Scientific Review, National Institutes of activities related to developing and the statement to the Contact Person listed on Health, 6701 Rockledge Drive, Room 4176, evaluating hypotheses, systematically MSC 7850, Bethesda, MD 20892, (301) 435– this notice. The statement should include the documenting findings and disseminating 1248, [email protected]. name, address, telephone number and when results. The Board shall evaluate the degree Name of Committee: Center for Scientific to which the activities of the National applicable, the business or professional Review Special Emphasis Panel; Emergency Institute for Occupational Safety and Health: affiliation of the interested person. Medical Services for Children. (1) Conform to appropriate scientific (Catalogue of Federal Domestic Assistance Date: December 10, 2009. standards, (2) address current, relevant Program Nos. 93.853, Clinical Research Time: 1 p.m. to 4 p.m. needs, and (3) produce intended results. Related to Neurological Disorders; 93.854, Agenda: To review and evaluate grant Matters To Be Discussed: Agenda items Biological Basis Research in the applications. include NIOSH Implementation of National Neurosciences, National Institutes of Health, Place: National Institutes of Health, 6701 Academies Program Recommendations for Rockledge Drive, Bethesda, MD 20892 HHS) Traumatic Injuries, Construction Research, (Virtual Meeting). and Health Hazard Evaluations; Future Dated: November 13, 2009. Contact Person: Jacinta Bronte-Tinkew, Directions for Evaluation of NIOSH Research Jennifer Spaeth, PhD, Scientific Review Officer, Center for Programs; Future Meetings and Closing Scientific Review, National Institutes of Remarks. Director, Office of Federal Advisory Health, 6701 Rockledge Drive, Room 3164, Agenda items are subject to change as Committee Policy. MSC 7770, Bethesda, MD 20892, (301) 435– priorities dictate. [FR Doc. E9–27706 Filed 11–17–09; 8:45 am] 1503, [email protected]. Contact Person for More Information: BILLING CODE 4140–01–P (Catalogue of Federal Domestic Assistance Roger Rosa, Executive Secretary, BSC, Program Nos. 93.306, Comparative Medicine; NIOSH, CDC, 395 E Street, SW., Suite 9200,
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Patriots Plaza Building, Washington, DC Submit written comments to the the risks and how these products should 20201, telephone (202) 245–0655, fax (202) Division of Dockets Management (HFA– be used. 245–0664. 305), Food and Drug Administration, On March 3, 2009, FDA held a The Director, Management Analysis and meeting with affected sponsors to Services Office, has been delegated the 5630 Fishers Lane, rm. 1061. Rockville, authority to sign Federal Register notices MD 20852. Submit electronic comments discuss how the REMS could be pertaining to announcements of meetings and to http://www.regulations.gov. All designed to manage the risks while also other committee management activities for comments should be identified with the minimizing burdens to the health care both the CDC and the Agency for Toxic docket number found in brackets in the system. FDA presented a high-level Substances and Disease Registry. heading of this document. overview, regulatory background, and Dated: November 6, 2009. A live webcast of this meeting will be the proposed elements of the REMS Elaine L. Baker, viewable at http://ConnectLive.com/ followed by questions and comments from the sponsors. At this meeting, FDA Director, Management Analysis and Services events/fda120409 on the day of the Office, Centers for Disease Control and meeting. A video record of the meeting encouraged sponsors to work Prevention. will be available at the same Web collectively to develop a proposed [FR Doc. E9–27623 Filed 11–17–09; 8:45 am] address for 1 year. REMS. The FDA presentations and minutes from this meeting are available BILLING CODE 4163–18–P FOR FURTHER INFORMATION CONTACT: on the agency’s Web site at http:// Theresa (Terry) Martin, Center for Drug www.fda.gov/Drugs/DrugSafety/ Evaluation and Research, Food and DEPARTMENT OF HEALTH AND InformationbyDrugClass/ Drug Administration, 10903 New HUMAN SERVICES ucm163660.htm. In May, FDA held Hampshire Ave., Bldg. 51, rm. 6196, meetings with other affected Food and Drug Administration Silver Spring, MD 20993, 301–796– stakeholders including health care 3448, FAX: 301–847–8753, or professionals, patient advocates, and [Docket No. FDA–2009–N–0143] Patrick Frey, Center for Drug pharmacy groups. FDA then held a Risk Evaluation and Mitigation Evaluation and Research, Food and public meeting on May 27 and 28, 2009, Strategies for Certain Opioid Drugs; Drug Administration, 10903 New where FDA heard from members of the Notice of Public Meeting Hampshire Ave., Bldg. 51, rm. 6350, public on what the REMS should look Silver Spring, MD 20993, 301–796– like for these products, how to minimize AGENCY: Food and Drug Administration, 3844, FAX: 301–847–8443, e-mail: the burden on the health care HHS. [email protected]. community and patients, and how FDA ACTION: Notice of public meeting. should evaluate the REMS to determine SUPPLEMENTARY INFORMATION: whether it achieves its objectives. SUMMARY: The Food and Drug I. Background Nearly 100 members of the public spoke Administration (FDA) is announcing a at the meeting, and many others have meeting with sponsors of certain opioid On February 6, 2009, the Food and submitted written comments to the drug products regarding the Drug Administration (FDA) sent letters docket (Docket No. FDA–2009–N–0143). development of Risk Evaluation and to manufacturers of certain opioid drug For additional background information Mitigation Strategies (REMS) for these products, indicating that these drugs about this issue see 74 FR 17967, April products. Other members of the public will be required to have a Risk 20, 2009. are invited to attend and observe. The Evaluation and Mitigation Strategy REMS is intended to ensure that the (REMS) to ensure that the benefits of the II. Purpose of Meeting benefits of these drugs continue to drugs continue to outweigh the risks. A The purpose of this meeting is for outweigh certain risks. FDA has table of opioid products that will be FDA to hear from sponsors of long- encouraged affected sponsors to work required to have REMS is available on acting opioids and extended-release collectively to develop a proposed the agency’s Web site at http:// opioid products on the development of REMS. The purpose of this meeting is to www.fda.gov/Drugs/DrugSafety/ the REMS for these products and their hear from sponsors about the status of InformationbyDrugClass/ views about the specific features of the the development of a proposed REMS ucm163654.htm. Copies of this REMS. Other members of the public are and their views regarding the specific document may be requested from invited to attend the meeting as features of the REMS for these products. Theresa (Terry) Martin (see FOR FURTHER observers. Because this is a meeting To promote transparency of the REMS INFORMATION CONTACT). The affected between FDA staff and the sponsors, development process, other members of opioid drugs include brand name and only FDA staff will be permitted to the public are invited to attend the generic products and are formulated question the sponsors at the meeting. meeting as observers. Additional with the active ingredients fentanyl, However, interested persons who attend opportunities for public input will be hydromorphone, methadone, morphine, the public meeting will be given an provided before FDA finalizes the oxycodone, and oxymorphone. The opportunity to provide suggestions for elements of the REMS. REMS would be intended to ensure that questions for FDA staff to ask the DATES: The meeting will be held on the benefits of these drugs continue to sponsors, at FDA’s sole discretion. December 4, 2009, from 9 a.m. to 1 p.m. outweigh the risks associated with: (1) Index cards will be provided for this To ensure consideration at the meeting, Use of high doses of long-acting opioids purpose. There will be additional submit comments by November 27, and extended-release opioid products in opportunities for public input before 2009. Register to attend the meeting by non-opioid-tolerant and inappropriately FDA finalizes the elements of the REMS. November 27, 2009. See section III of selected individuals; (2) abuse; (3) this document for information on how misuse; and (4) overdose, both III. Attendance and Registration to register for the meeting. accidental and intentional. REMS for Registration: Register by e-mail to ADDRESSES: The public meeting will be these opioids would likely include [email protected]. Provide held at the Holiday Inn Washington- elements to assure safe use to ensure complete contact information for each College Park, 10000 Baltimore Ave., that prescribers, dispensers, and attendee, including name, title, College Park, MD 20740. patients are aware of, and understand, affiliation, address, e-mail, and phone
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number. Registration requests should be DEPARTMENT OF HEALTH AND The meeting will be closed to the received by November 27, 2009. HUMAN SERVICES public in accordance with the Registration is free and will be on a first- provisions set forth in sections come, first-served basis. Early National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., registration is recommended because as amended. The grant applications and National Cancer Institute; Notice of seating is limited. FDA may limit the the discussions could disclose Closed Meeting number of participants from each confidential trade secrets or commercial organization based on space limitations. Pursuant to section 10(d) of the property such as patentable material, Registrants will receive confirmation Federal Advisory Committee Act, as and personal information concerning once they have been accepted. Onsite amended (5 U.S.C. App.), notice is individuals associated with the grant registration on the day of the meeting hereby given of the following meeting. applications, the disclosure of which would constitute a clearly unwarranted will be based on space availability on The meeting will be closed to the invasion of personal privacy. the day of the event starting at 8 a.m. public in accordance with the provisions set forth in sections Name of Committee: Center for Scientific If you need special accommodations Review Special Emphasis Panel; Addictions, because of disability, please contact 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and Drugs, and Violence. Theresa (Terry) Martin (see FOR FURTHER Date: November 24, 2009. the discussions could disclose INFORMATION CONTACT) at least 7 days Time: 3 p.m. to 5 p.m. confidential trade secrets or commercial before the meeting. Agenda: To review and evaluate grant property such as patentable material, applications. In addition, a live webcast of this and personal information concerning Place: National Institutes of Health, 6701 meeting will be viewable at http:// individuals associated with the grant Rockledge Drive, Bethesda, MD 20892 ConnectLive.com/events/fda120409 on applications, the disclosure of which (Telephone Conference Call). the day of the meeting. A video record would constitute a clearly unwarranted Contact Person: Michael Micklin, PhD, of the meeting will be available at the invasion of personal privacy. Scientific Review Officer, Center for same Web address for 1 year. Scientific Review, National Institutes of Name of Committee: National Cancer Health, 6701 Rockledge Drive, Room 3136, IV. Comments Institute Initial Review Group; Subcommittee MSC 7759, Bethesda, MD 20892, (301) 435– A—Cancer Centers. 1258, [email protected]. In addition, any person may submit Date: December 10–11, 2009. This notice is being published less than 15 written or electronic comments to the Time: 8 a.m. to 12:10 p.m. days prior to the meeting due to the timing Agenda: To review and evaluate grant Division of Dockets Management (see limitations imposed by the review and applications. funding cycle. DATES and ADDRESSES). Submit a single Place: Residence Inn Bethesda, 7335 (Catalogue of Federal Domestic Assistance copy of electronic comments or two Wisconsin Avenue, Bethesda, MD 20814. Program Nos. 93.306, Comparative Medicine; Contact Person: Gail J Bryant, MD, paper copies of any mailed comments, 93.333, Clinical Research, 93.306, 93.333, Scientific Review Officer, Resources and except that individuals may submit one 93.337, 93.393–93.396, 93.837–93.844, Training Review Branch, Division of paper copy. Comments are to be 93.846–93.878, 93.892, 93.893, National Extramural Activities, National Cancer Institutes of Health, HHS) identified with the docket number Institute, 6116 Executive Blvd., Room 8107, found in brackets in the heading of this MSC 8328, Bethesda, MD 20892–8328, (301) Dated: November 12, 2009. document. Received comments may be 402–0801, [email protected]. Jennifer Spaeth, seen in the Division of Dockets (Catalogue of Federal Domestic Assistance Director, Office of Federal Advisory Management between 9 a.m. and 4 p.m., Program Nos. 93.392, Cancer Construction; Committee Policy. Monday through Friday. 93.393, Cancer Cause and Prevention [FR Doc. E9–27704 Filed 11–17–09; 8:45 am] Research; 93.394, Cancer Detection and V. Transcripts Diagnosis Research; 93.395, Cancer BILLING CODE 4140–01–P Treatment Research; 93.396, Cancer Biology Transcripts of the meeting will be Research; 93.397, Cancer Centers Support; available for review at the Division of 93.398, Cancer Research Manpower; 93.399, DEPARTMENT OF HEALTH AND Dockets Management and on the Cancer Control, National Institutes of Health, HUMAN SERVICES Internet at http://www.regulations.gov HHS) National Institutes of Health approximately 30 days after the Dated: November 12, 2009. meeting. A transcript will also be made Jennifer Spaeth, National Heart, Lung, and Blood available in either hard copy or on CD– Director, Office of Federal Advisory Institute; Notice of Closed Meetings ROM, upon submission of a Freedom of Committee Policy. Information request. Written requests [FR Doc. E9–27715 Filed 11–17–09; 8:45 am] Pursuant to section 10(d) of the are to be sent to Division of Freedom of BILLING CODE 4140–01–P Federal Advisory Committee Act, as Information (HFI–35), Office of amended (5 U.S.C. App.), notice is Management Programs, Food and Drug hereby given of the following meetings. Administration, 5600 Fishers Lane, rm. DEPARTMENT OF HEALTH AND The meetings will be closed to the 6–30, Rockville, MD 20857. HUMAN SERVICES public in accordance with the provisions set forth in sections Dated: November 12, 2009. National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., David Horowitz, as amended. The grant applications and Assistant Commissioner for Policy. Center for Scientific Review; Notice of Closed Meeting the discussions could disclose [FR Doc. E9–27718 Filed 11–17–09; 8:45 am] confidential trade secrets or commercial BILLING CODE 4160–01–S Pursuant to section 10(d) of the property such as patentable material, Federal Advisory Committee Act, as and personal information concerning amended (5 U.S.C. App.), notice is individuals associated with the grant hereby given of the following meeting. applications, the disclosure of which
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would constitute a clearly unwarranted Dated: November 12, 2009. Contact Person: Jean D. Sipe, PhD, invasion of personal privacy. Jennifer Spaeth, Scientific Review Officer, Center for Scientific Review, National Institutes of Name of Committee: National Heart, Lung, Director, Office of Federal Advisory Committee Policy. Health, 6701 Rockledge Drive, Room 4106, and Blood Institute Special Emphasis Panel; MSC 7814, Bethesda, MD 20892, 301/435– Ancillary Studies in Clinical Trials. [FR Doc. E9–27703 Filed 11–17–09; 8:45 am] 1743, [email protected]. Date: December 4, 2009. BILLING CODE 4140–01–P (Catalogue of Federal Domestic Assistance Time: 8 a.m. to 5 p.m. Program Nos. 93.306, Comparative Medicine; Agenda: To review and evaluate grant 93.333, Clinical Research, 93.306, 93.333, applications. DEPARTMENT OF HEALTH AND 93.337, 93.393–93.396, 93.837–93.844, Place: Ritz Carlton Hotel, 1150 22nd Street, HUMAN SERVICES 93.846–93.878, 93.892, 93.893, National NW., Washington, DC 20037. Institutes of Health, HHS) Contact Person: Chang Sook Kim, PhD, National Institutes of Health Scientific Review Officer, Review Branch, Dated: November 12, 2009. DERA, National Heart, Lung, and Blood Center for Scientific Review; Notice of Jennifer Spaeth, Institute, 6701 Rockledge Drive, Room 7190, Closed Meetings Director, Office of Federal Advisory Bethesda, MD 20892, 301–435–0287, Committee Policy. Pursuant to section 10(d) of the [email protected]. [FR Doc. E9–27696 Filed 11–17–09; 8:45 am] Federal Advisory Committee Act, as Name of Committee: National Heart, Lung, BILLING CODE 4140–01–P and Blood Institute Special Emphasis Panel; amended (5 U.S.C. App.), notice is Program Project in Respiratory Muscle hereby given of the following meetings. Failure. The meetings will be closed to the DEPARTMENT OF HEALTH AND Date: December 10, 2009. public in accordance with the HUMAN SERVICES Time: 10 a.m. to 2 p.m. provisions set forth in sections Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Food and Drug Administration applications. as amended. The grant applications and Place: National Institutes of Health, 6701 the discussions could disclose [Docket No. FDA–2009–N–0664] Rockledge Drive, Bethesda, MD 20892 confidential trade secrets or commercial Anti-Infective Drugs Advisory (Telephone Conference Call). property such as patentable material, Contact Person: William J Johnson, PhD, Committee; Amendment of Notice Scientific Review Officer, Review Branch/ and personal information concerning DERA, National Heart, Lung, and Blood individuals associated with the grant AGENCY: Food and Drug Administration, Institute, 6701 Rockledge Drive, Room 7178, applications, the disclosure of which HHS. Bethesda, MD 20892–7924, 301–435–0725, would constitute a clearly unwarranted ACTION: Notice. [email protected]. invasion of personal privacy. Name of Committee: National Heart, Lung, Name of Committee: Center for Scientific SUMMARY: The Food and Drug and Blood Institute Special Emphasis Panel; Review Special Emphasis Panel; ARRA Administration (FDA) is announcing an NHLBI Programs of Excellence in AREA Special Emphasis Panel 08. amendment to the notice of meeting of Nanotechology. Date: December 4, 2009. the Anti-Infective Drugs Advisory Date: December 11, 2009. Time: 8 a.m. to 5 p.m. Committee. This meeting was Time: 8:30 a.m. to 3 p.m. Agenda: To review and evaluate grant announced in the Federal Register of Agenda: To review and evaluate contract applications. October 26, 2009 (74 FR 55057). The proposals. Place: Ritz Carlton Hotel, 1150 22nd Street, NW., Washington, DC 20037. amendment is being made to reflect a Place: Ritz Carlton Hotel, 1150 22nd Street, change in the Location portion of the NW., Washington, DC 20037. Contact Person: Edwin C. Clayton, PhD, document. There are no other changes. Contact Person: Youngsuk Oh, PhD, Scientific Review Officer, Center for Scientific Review Officer, Review Branch/ Scientific Review, National Institutes of FOR FURTHER INFORMATION CONTACT: DERA, National Heart, Lung, and Blood Health, 6701 Rockledge Drive, Room 5095C, Minh Doan, Center for Drug Evaluation Institute, 6701 Rockledge Drive, Room 7182, MSC 7844, Bethesda, MD 20892, (301) 402– and Research (HFD–21), Food and Drug 1304, [email protected]. Bethesda, MD 20892–7924, 301–435–0277, Administration, 5600 Fishers Lane, (for [email protected]. Name of Committee: Center for Scientific express delivery, 5630 Fishers Lane, rm. Review Special Emphasis Panel; RFA–OD– Name of Committee: National Heart, Lung, 09–007: ARRA AREA Grants Panel 05. 1093), Rockville, MD 20857, 301–827– and Blood Institute Special Emphasis Panel; Date: December 7, 2009. 7001, FAX: 301–827–6776, e-mail: Translational Programs in Lung Diseases. Time: 8 a.m. to 5 p.m. [email protected], or FDA Date: December 17, 2009. Agenda: To review and evaluate grant Advisory Committee Information Line, Time: 8 a.m. to 5 p.m. applications. 1–800–741–8138 (301–443–0572 in the Agenda: To review and evaluate grant Place: The Fairmont Washington, DC, 2401 Washington DC area), code 3014512530. applications. M Street, NW., Washington, DC 20037. Place: Doubletree Hotel Bethesda Please call the Information Line for up- Contact Person: Dana Jeffrey Plude, PhD, to-date information on this meeting. (Formerly Holiday Inn Select), 8120 Scientific Review Officer, Center for Wisconsin Avenue, Bethesda, MD 20814. Scientific Review, National Institutes of SUPPLEMENTARY INFORMATION: In the Contact Person: Shelley S Sehnert, PhD, Health, 6701 Rockledge Drive, Room 3176, Federal Register of October 26, 2009, Scientific Review Officer, Review Branch/ MSC 7848, Bethesda, MD 20892, 301–435– FDA announced that a meeting of the DERA, National Heart, Lung, and Blood 2309, [email protected]. Anti-Infective Drugs Advisory Institute, 6701 Rockledge Drive, Room 7206, Name of Committee: Center for Scientific Committee would be held on December Bethesda, MD 20892–7924, 301–435–0303, Review Special Emphasis Panel; RFA–OD– [email protected]. 9, 2009. On page 55057, in the second 09–007: ARRA AREA Grants Panel 11. column, the Location portion of the (Catalogue of Federal Domestic Assistance Date: December 7, 2009. Program Nos. 93.233, National Center for document is changed to read as follows: Time: 8:30 a.m. to 5 p.m. Location: Hilton Washington DC Sleep Disorders Research; 93.837, Heart and Agenda: To review and evaluate grant Vascular Diseases Research; 93.838, Lung applications. North/Gaithersburg, The Ballrooms, 620 Diseases Research; 93.839, Blood Diseases Place: Hyatt Regency Bethesda, One Perry Pkwy., Gaithersburg, MD. The and Resources Research, National Institutes Bethesda Metro Center, 7400 Wisconsin hotel telephone number is 301–977– of Health, HHS) Avenue, Bethesda, MD 20814. 8900.
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This notice is issued under the 109, Bethesda, MD 20892, 301–451–5870, DEPARTMENT OF HEALTH AND Federal Advisory Committee Act (5 [email protected]. HUMAN SERVICES U.S.C. app. 2) and 21 CFR part 14, Any interested person may file written relating to the advisory committees. comments with the committee by forwarding Food and Drug Administration the statement to the Contact Person listed on Dated: November 12, 2009. this notice. The statement should include the [Docket No. FDA–2009–N–0667] David Horowitz, name, address, telephone number and when [FDA 225–09–0013] Assistant Commissioner for Policy. applicable, the business or professional [FR Doc. E9–27693 Filed 11–17–09; 8:45 am] affiliation of the interested person. Memorandum of Understanding BILLING CODE 4160–01–S In the interest of security, NIH has Between the Food and Drug instituted stringent procedures for entrance Administration and Waterfront Media onto the NIH campus. All visitor vehicles, AGENCY: Food and Drug Administration, DEPARTMENT OF HEALTH AND including taxicabs, hotel, and airport shuttles HHS. HUMAN SERVICES will be inspected before being allowed on ACTION: campus. Visitors will be asked to show one Notice. National Institutes of Health form of identification (for example, a SUMMARY: The Food and Drug government-issued photo ID, driver’s license, Office of the Director, National Administration (FDA) is providing or passport) and to state the purpose of their Institutes of Health; Notice of Meeting notice of a memorandum of visit. understanding (MOU) between FDA and Information is also available on the Pursuant to section 10(a) of the Waterfront Media. The purpose of the Institute’s/Center’s home page: http:// Federal Advisory Committee Act, as MOU is to extend the reach of FDA www.nih.gov/aboutldirector/acd.htm, where amended (5 U.S.C. App.), notice is Consumer Health Information and to an agenda and any additional information for provide consumers with better hereby given of a meeting of the the meeting will be posted when available. Advisory Committee to the Director, information and timely content NIH. (Catalogue of Federal Domestic Assistance concerning public health and safety Program Nos. 93.14, Intramural Research The meeting will be open to the topics, including alerts of emerging Training Award; 93.22, Clinical Research safety issues and product recalls. public, with attendance limited to space Loan Repayment Program for Individuals DATES: available. Individuals who plan to from Disadvantaged Backgrounds; 93.232, The agreement became effective attend and need special assistance, such Loan Repayment Program for Research October 14, 2009. as sign language interpretation or other Generally; 93.39, Academic Research FOR FURTHER INFORMATION CONTACT: reasonable accommodations, should Enhancement Award; 93.936, NIH Acquired Jason Brodsky, Consumer Health notify the Contact Person listed below Immunodeficiency Syndrome Research Loan Information Staff, Office of External in advance of the meeting. Repayment Program; 93.187, Undergraduate Relations (HFI–40), Food and Drug Name of Committee: Advisory Committee Scholarship Program for Individuals from Administration, 5600 Fishers Lane, to the Director, NIH. Disadvantaged Backgrounds, National Rockville, MD 20857, 301–827–6251, e- Date: December 4, 2009. Institutes of Health, HHS) mail: [email protected]. Time: 8:30 a.m. to 5 p.m. Dated: November 5, 2009. SUPPLEMENTARY INFORMATION: In Agenda: Among the topics proposed for Jennifer Spaeth, accordance with 21 CFR 20.108(c), discussion are: (1) NIH Director’s Report; (2) which states that all written agreements NIH Director’s Council of Public Director, Office of Federal Advisory Representatives Liaison Report; and (3) other and MOUs between FDA and others Committee Policy. shall be published in the Federal business of the Committee. [FR Doc. E9–27411 Filed 11–17–09; 8:45 am] Place: National Institutes of Health, Register, the agency is publishing notice Building 31, Conference Room 6, 9000 BILLING CODE 4140–01–M of this MOU. Rockville Pike, Bethesda, MD 20852. Dated: November 12, 2009. Contact Person: Penny W. Burgoon, PhD, Senior Assistant to the Deputy Director, David Horowitz, Office of the Director, National Institutes of Assistant Commissioner for Policy. Health, 1 Center Drive, Building 1, Room BILLING CODE 4160–01–S
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[FR Doc. E9–27630 Filed 11–17–09; 8:45 am] BILLING CODE 4160–01–C
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DEPARTMENT OF HEALTH AND considered the request and is extending allowing for a 60-day comment period. HUMAN SERVICES the comment period for the notice This notice allows for an additional 30 entitled ‘‘Acrylamide in Food; Request days for public comments. This process Food and Drug Administration for Comments and for Scientific Data is conducted in accordance with 5 CFR [Docket No. FDA–2009–N–0393] and Information,’’ until January 25, 1320.10. 2010. The agency believes that this DATES: Written comments should be Acrylamide in Food; Request for extension allows adequate time for received on or before December 18, Comments and for Scientific Data and interested persons to submit comments 2009. Information; Extension of Comment without significantly delaying action by ADDRESSES: Period the agency. Interested persons are invited to submit written comments on AGENCY: Food and Drug Administration, II. Request for Comments the proposed information collection to HHS. Interested persons may submit to the the Office of Information and Regulatory ACTION: Notice; request for comments Division of Dockets Management (see Affairs, Office of Management and and scientific data and information; ADDRESSES) electronic or written Budget. Comments should be addressed extension of comment period. comments on this document. Submit a to the OMB Desk Officer for Customs single copy of electronic comments or and Border Protection, Department of SUMMARY: The Food and Drug two paper copies of any mailed Homeland Security, and sent via Administration (FDA) is extending to comments, except that individuals may electronic mail to January 25, 2010, the comment period submit one paper copy. Comments are [email protected] or faxed for the notice entitled ‘‘Acrylamide in to be identified with the docket number to (202) 395–5806. Food; Request for Comments and for found in brackets in the heading of this SUPPLEMENTARY INFORMATION: U.S. Scientific Data and Information,’’ that document. Received comments may be Customs and Border Protection (CBP) appeared in the Federal Register of seen in the Division of Dockets encourages the general public and August 26, 2009 (74 FR 43134). In the Management between 9 a.m. and 4 p.m., affected Federal agencies to submit notice, FDA requested comments and Monday through Friday. written comments and suggestions on scientific data and information on Dated: November 10, 2009. proposed and/or continuing information acrylamide in food. The agency is taking David Horowitz, collection requests pursuant to the this action in response to a request for Assistant Commissioner for Policy. Paperwork Reduction Act (Pub. L. 104– an extension to allow interested persons 13). Your comments should address one additional time to submit comments. [FR Doc. E9–27692 Filed 11–17–09; 8:45 am] BILLING CODE 4160–01–S of the following four points: DATES: Submit written or electronic (1) Evaluate whether the proposed comments by January 25, 2010. collection of information is necessary ADDRESSES: Submit electronic DEPARTMENT OF HOMELAND for the proper performance of the comments and scientific data and SECURITY functions of the agency/component, information to http:// including whether the information will www.regulations.gov. Submit written U.S. Customs and Border Protection have practical utility; comments and scientific data and (2) Evaluate the accuracy of the information to the Division of Dockets Agency Information Collection agencies/components estimate of the Management (HFA–305), Food and Drug Activities: Application for Allowance in burden of the proposed collection of Administration, 5630 Fishers Lane, rm. Duties information, including the validity of 1061, Rockville, MD 20852. the methodology and assumptions used; AGENCY: U.S. Customs and Border FOR FURTHER INFORMATION CONTACT: Protection, Department of Homeland (3) Enhance the quality, utility, and Lauren Posnick Robin, Center for Food Security. clarity of the information to be Safety and Applied Nutrition (HFS– collected; and ACTION: 30-Day notice and request for (4) Minimize the burden of the 317), Food and Drug Administration, comments; Revision of an existing collections of information on those who 5100 Paint Branch Pkwy., College Park, information collection: 1651–0007. MD 20740, 301–436–1639. are to respond, including the use of SUPPLEMENTARY INFORMATION: SUMMARY: U.S. Customs and Border appropriate automated, electronic, Protection (CBP) of the Department of mechanical, or other technological I. Background Homeland Security has submitted the techniques or other forms of In the Federal Register of August 26, following information collection request information. 2009 (74 FR 43134), FDA published a to the Office of Management and Budget Title: Application for Allowance in notice with a 90-day comment period to (OMB) for review and approval in Duties. request comments and scientific data accordance with the Paperwork OMB Number: 1651–0007. and information on acrylamide in food. Reduction Act: Application for Form Number: CBP Form 4315. Comments on practices that Allowance in Duties. This is a proposed Abstract: Form 4315 is required by manufacturers have used to reduce extension and revision of an CBP in instances of claims of damaged acrylamide in food and the reductions information collection that was or defective imported merchandise on they have been able to achieve in previously approved. CBP is proposing which an allowance in duty is made in acrylamide levels will assist in FDA’s that this information collection be the liquidation of an entry. The development of guidance for industry extended with no change to the burden information is used to substantiate an on reduction of acrylamide levels in hours. This document is published to importer’s claim for such duty food products, should FDA decide to obtain comments from the public and allowances. issue guidance on this topic. affected agencies. This proposed Current Actions: There are no changes The agency has received a request for information collection was previously to the information collection. This a 60-day extension of the comment published in the Federal Register (74 submission is being made to extend the period for this notice. FDA has FR 45872) on September 4, 2009, expiration date.
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Type of Review: Extension (without SUPPLEMENTARY INFORMATION: to http://www.regulations.gov, inserting change). USCG–2009–0975 in the ‘‘Keyword’’ Background and Purpose Affected Public: Businesses. box, and then clicking ‘‘Search.’’ Estimated Number of Respondents: The offshore supply vessel TERREL FOR FURTHER INFORMATION CONTACT: If 12,000. TIDE will be used for offshore supply you have questions on this notice, call Estimated Number of Annual operations. The horizontal distance CWO2 David Mauldin, District Eight, Responses per Respondent: 1. between the forward and aft masthead Prevention Branch, U.S. Coast Guard, Estimated Time per Respondent: 8 lights may be 25′–9″. Placing the aft telephone 504–671–2153. If you have minutes. masthead light at the horizontal questions on viewing or submitting Estimated Total Annual Burden distance from the forward masthead material to the docket, call Renee V. Hours: 1,600. light as required by Annex I, paragraph Wright, Program Manager, Docket If additional information is required 3(a) of the 72 COLREGS, and Annex I, Operations, telephone 202–366–9826. contact: Tracey Denning, U.S. Customs Section 84.05(a) of the Inland Rules Act, SUPPLEMENTARY INFORMATION: and Border Protection, Office of would result in an aft masthead light Regulations and Rulings, 799 9th Street, location directly over the cargo deck, Background and Purpose NW., 7th Floor, Washington, DC 20229– where it would interfere with loading The offshore supply vessel GRANT 1177, at 202–325–0265. and unloading operations. CANDIES will be used for offshore Dated: November 13, 2009. The Certificate of Alternative supply operations. Full compliance Tracey Denning, Compliance allows for the horizontal with 72 COLREGS and Inland Rules Act Agency Clearance Officer, Customs and separation of the forward and aft will hinder the vessel’s ability to Border Protection. masthead lights to deviate from the maneuver within close proximity of [FR Doc. E9–27652 Filed 11–17–09; 8:45 am] requirements of Annex I, paragraph 3(a) offshore platforms and conduct of 72 COLREGS, and Annex I, Section helicopter operations. The forward BILLING CODE 9111–14–P 84.05(a) of the Inland Rules Act. masthead light may be located forward This notice is issued under authority of the helideck 10.37 meters above the DEPARTMENT OF HOMELAND of 33 U.S.C. 1605(c), and 33 CFR 81.18. hull. Placing the forward masthead light SECURITY Dated: November 4, 2009. at the height as required by Annex I, paragraph 2(a) of the 72 COLREGS J. W. Johnson, Coast Guard would result in a masthead light Commander, U.S. Coast Guard, Chief, location that would interfere with [Docket No. USCG–2009–0974] Inspections and Investigations Branch, by Direction of the Commander, Eighth Coast helideck operations. In addition, the horizontal distance Certificate of Alternative Compliance Guard District. between the forward and aft masthead for the Offshore Supply Vessel [FR Doc. E9–27637 Filed 11–17–09; 8:45 am] lights may be 32.845 meters. Placing the TERREL TIDE BILLING CODE 9110–04–P aft masthead light at the horizontal AGENCY: Coast Guard, DHS. distance from the forward masthead ACTION: Notice. DEPARTMENT OF HOMELAND light as required by Annex I, paragraph SECURITY 3(a) of the 72 COLREGS would result in SUMMARY: The Coast Guard announces an aft masthead light location directly that a Certificate of Alternative Coast Guard over the aft cargo deck where it would Compliance was issued for the offshore interfere with loading and unloading supply vessel TERREL TIDE as required [Docket No. USCG–2009–0975] operations. by 33 U.S.C. 1605(c) and 33 CFR 81.18. Furthermore, the sidelights may be Certificate of Alternative Compliance DATES: The Certificate of Alternative placed 2.417 meters above the forward for the Offshore Supply Vessel GRANT masthead light. Placing the sidelights Compliance was issued on October 15, CANDIES 2009. lower than the forward masthead light as required by Annex I, paragraph 2(g) ADDRESSES: AGENCY: Coast Guard, DHS. The docket for this notice is of 72 COLREGS and Annex I, paragraph available for inspection or copying at ACTION: Notice. 84.03(g) of the Inland Rules Act, would the Docket Management Facility (M–30), subject them to interference from the U.S. Department of Transportation, SUMMARY: The Coast Guard announces that a Certificate of Alternative deck lights and obstruction by the West Building Ground Floor, Room helideck. W12–140, 1200 New Jersey Avenue, SE., Compliance was issued for the offshore supply vessel GRANT CANDIES as The Certificate of Alternative Washington, DC 20590, between 9 a.m. Compliance allows for the vertical required by 33 U.S.C. 1605(c) and 33 and 5 p.m., Monday through Friday, placement of the forward masthead light CFR 81.18. except Federal holidays. You may also to deviate from requirements set forth in find this docket on the Internet by going DATES: The Certificate of Alternative Annex I, paragraph 2(a) of 72 COLREGS. to http://www.regulations.gov, inserting Compliance was issued on October 28, In addition, the Certificate of USCG–2009–0974 in the ‘‘Keyword’’ 2009. Alternative Compliance allows for the box, and then clicking ‘‘Search.’’ ADDRESSES: The docket for this notice is horizontal separation of the forward and FOR FURTHER INFORMATION CONTACT: If available for inspection or copying at aft masthead lights to deviate from the you have questions on this notice, call the Docket Management Facility (M–30), requirements of Annex I, paragraph 3(a) CWO2 David Mauldin, District Eight, U.S. Department of Transportation, of 72 COLREGS. Furthermore, the Prevention Branch, U.S. Coast Guard, West Building Ground Floor, Room Certificate of Alternative Compliance telephone 504–671–2153. If you have W12–140, 1200 New Jersey Avenue, SE., allows for the placement of the questions on viewing or submitting Washington, DC 20590, between 9 a.m. sidelights to deviate from requirements material to the docket, call Renee V. and 5 p.m., Monday through Friday, set forth in Annex I, paragraph 2(g) of Wright, Program Manager, Docket except Federal holidays. You may also 72 COLREGS and Annex I, paragraph Operations, telephone 202–366–9826. find this docket on the Internet by going 84.03(g) of the Inland Rules Act.
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This notice is issued under authority Districts’’ published in the Federal information or they may participate in of 33 U.S.C. 1605(c), and 33 CFR 81.18. Register as T.D. 00–18 on March 15, person by coming to Room 1303, U.S. Dated: November 4, 2009. 2000 (65 FR 14011). Coast Guard Headquarters Building, J. W. Johnson, Section 1893 of the Tax Reform Act of 2100 Second Street, SW., Washington 1986 (Pub. L. 99–514) provides that DC 20593. As there are a limited Commander, U.S. Coast Guard, Chief, Inspections and Investigations Branch, by notices of the date on which the number of teleconference lines, public Direction of the Commander, Eighth Coast payment is due for each broker permit participation will be on a first come Guard District. shall be published by the Secretary of basis. Written comments should be sent [FR Doc. E9–27636 Filed 11–17–09; 8:45 am] the Treasury in the Federal Register by to Commander P.W. Clark, Designated no later than 60 days before such due BILLING CODE 9110–04–P Federal Officer of NOSAC, Commandant date. Please note that section 403 of the (CG–5222), 2100 Second Street, SW., Homeland Security Act of 2002, 6 Washington, DC 20593–0001; or by fax DEPARTMENT OF HOMELAND U.S.C. 101 et seq., (Pub. L. 107–296) and to 202–372–1926. This notice is SECURITY Treasury Department Order No. 100–16 available on our online docket, USCG– (see Appendix to 19 CFR Part 0) 2009-xxxx, at http:// Customs and Border Protection delegated general authority vested in the www.regulations.gov. Secretary of the Treasury over customs FOR FURTHER INFORMATION CONTACT: Customs Brokers User Fee Payment revenue functions (with certain for 2010 Commander P.W. Clark, Designated specified exceptions) to the Secretary of Federal Officer of NOSAC, or Mr. Jim AGENCY: Customs and Border Protection, Homeland Security. Magill, Assistant Designated Federal Department of Homeland Security. This document notifies customs Officer, telephone 202–372–1414, fax brokers that for calendar year 2010, the ACTION: General notice. 202–372–1926. due date for payment of the user fee is SUPPLEMENTARY INFORMATION: Public SUMMARY: This document provides January 25, 2010. participation is welcome and the public notice to customs brokers that the Dated: November 3, 2009. may participate in person by coming to annual fee of $138 that is assessed for Daniel Baldwin, Room 1303, U.S. Coast Guard each permit held by a broker, whether Assistant Commissioner, Office of Headquarters Building, 2100 Second it may be an individual, partnership, International Trade. Street, SW., Washington DC 20593 or by association, or corporation, is due by [FR Doc. E9–27598 Filed 11–17–09; 8:45 am] contacting CDR P.W. Clark at 202–372– January 25, 2010. Customs and Border BILLING CODE 9111–14–P 1410 for call in information. Notice of Protection (CBP) announces this date of this meeting is given under the Federal payment for 2010 in accordance with Advisory Committee Act, 5 U.S.C. App. the Tax Reform Act of 1986. DEPARTMENT OF HOMELAND 2. DATES: Payment of the 2010 Customs SECURITY Broker User Fee is due Monday, January Agenda of Meeting 25, 2010. Coast Guard The agenda for the December 8, 2009 FOR FURTHER INFORMATION CONTACT: [USCG–2009–0992] Committee meeting is as follows: Russell Morris, Broker Compliance (1) Roll call of Committee members Branch, Trade Policy and Programs, National Offshore Safety Advisory and the public participating in the Office of International Trade, (202) 863– Committee teleconference. 6543. (2) Approval of minutes from the AGENCY: Coast Guard, DHS. SUPPLEMENTARY INFORMATION: November 5, 2009. ACTION: Notice of open teleconference (3) Subcommittee’s Final Report on Background meeting. proposals for MARPOL Annex II, A.673 CBP Dec. 07–01 amended section standards for existing Offshore Supply SUMMARY: This notice announces a 111.96 of title 19 of the Code of Federal Vessels (OSVs). teleconference meeting of the National Regulations (19 CFR 111.96) pursuant to (4) Committee discussion and vote on Offshore Safety Advisory Committee the amendment of section 13031 of the Subcommittee’s Final Report for (NOSAC) to discuss items listed in the Consolidated Omnibus Budget MARPOL Annex II, A.673. agenda as well as other items that Reconciliation Act (COBRA) of 1985 (19 (5) Review of and possible NOSAC NOSAC may consider. This meeting U.S.C. 58c) by section 892 of the action to approve a recommendation to will be open to the public. American Jobs Creation Act of 2004, to re-establish the Diving Subcommittee establish that effective April 1, 2007, an DATES: The teleconference call will take and discussion on a proposed task annual user fee of $138 is to be assessed place on Thursday, December 8, 2009, statement to study the matter of medical for each customs broker permit and from 2 p.m. to 4 p.m. EST. This meeting treatment of injured divers while national permit held by an individual, may close early if all business is working on the OCS. partnership, association, or corporation. finished. Written material and requests (6) Review of background information Customs and Border Protection (CBP) to make oral presentations should reach and possible NOSAC action related to regulations provide that this fee is the Coast Guard on or before December minimizing offshore lifts on the OCS. payable for each calendar year in each 4, 2009. Requests to have a copy of your (7) Period for Public Comment. broker district where the broker was material distributed to each member of (8) Confirmation of the date/time for issued a permit to do business by the the committee should reach the Coast the next NOSAC Meeting (Thursday, due date which is published in the Guard on or before December 4, 2009. April 8, 2009 in New Orleans). Federal Register annually. See 19 CFR ADDRESSES: The Committee will meet, 24.22(h) and (i)(9). Broker districts are via telephone conference, on December Procedural defined in the General Notice entitled, 8, 2009. Members of the public wishing This meeting is open to the public. ‘‘Geographical Boundaries of Customs to participate may contact CDR P.W. Please note that the meeting may close Brokerage, Cartage and Lighterage Clark at 202–372–1410 for call in early if all business is finished. At the
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Chair’s discretion, members of the Assistance (CFDA) number for the number); e-mail public may make oral presentations HOPE VI Main Street Grants program is [email protected]. Persons with during the meeting. If you would like to 14.878. Applications must be submitted hearing or speech impairments may make an oral presentation during the electronically through Grants.gov. access these numbers via TTY by calling teleconference, please notify the DFO no FOR FURTHER INFORMATION CONTACT: the Federal Information Relay Service at later than December 4, 2009. Written Questions regarding specific program 800–877–8339. material for distribution to Committee requirements should be directed to the Dated: November 12, 2009. members should reach the Coast Guard agency contact identified in the program no later than December 4, 2009. NOFA. Questions regarding the 2009 David H. Stevens, Assistant Secretary for Housing—Federal Minutes General Section should be directed to the Office of Departmental Grants Housing Commissioner. Minutes from the meeting will be Management and Oversight at 202–708– [FR Doc. E9–27673 Filed 11–17–09; 8:45 am] available for the public review and 0667 (this is not a toll-free number) or BILLING CODE 4210–67–P copying 30 days following the the NOFA Information Center at 1–800– teleconference meeting. HUD–8929 (toll-free). Persons with Information on Services for Individuals hearing or speech impairments may DEPARTMENT OF HOUSING AND With Disabilities access these numbers via TTY by calling URBAN DEVELOPMENT the Federal Information Relay Service at For information on facilities or 1–800–877–8339. services for individuals with disabilities [Docket No. FR–5300–C–19] Dated: November 6, 2009. or to request special assistance at the HUD’s Fiscal Year (FY) 2009 NOFA for meeting, contact Mr. Jim Magill at 202– Sandra B. Henriquez, Section 811 Housing for Persons With 372–1414 as soon as possible. Assistant Secretary for Public and Indian Housing. Disabilities (Section 811 Program); Dated: November 10, 2009. [FR Doc. E9–27680 Filed 11–17–09; 8:45 am] Technical Correction J.G. Lantz, BILLING CODE 4210–67–P Director of Commercial Regulations and AGENCY: Office of the Assistant Standards. Secretary for Housing—Federal Housing [FR Doc. E9–27634 Filed 11–17–09; 8:45 am] DEPARTMENT OF HOUSING AND Commissioner, HUD. BILLING CODE 9110–04–P URBAN DEVELOPMENT ACTION: Notice; technical correction. [Docket No. FR–5300–C–21] SUMMARY: On September 1, 2009, HUD DEPARTMENT OF HOUSING AND HUD’s Fiscal Year (FY) 2009 NOFA for URBAN DEVELOPMENT posted its Notice of Funding Section 202 Supportive Housing for Availability (NOFA) for Section 811 [Docket No. FR–5300–N–24] the Elderly; Technical Correction Housing for Persons with Disabilities (Section 811 Program) for Fiscal Year Notice of Availability: Notice of AGENCY: Office of the Assistant 2009. The technical corrections to the Funding Availability (NOFA) for HUD’s Secretary for Housing—Federal Housing Fiscal Year (FY) 2009 HOPE VI Main Commissioner, HUD. NOFA are available on the Grants.gov Street Grants Program ACTION: Notice; technical correction. Web site at http://www.grants.gov. The CFDA number for Section 811 Housing AGENCY: Office of the Assistant SUMMARY: On September 1, 2009, HUD for Persons with Disabilities (Section Secretary for Public and Indian posted its Notice of Funding 811 Program) is 14.181. The technical Housing, HUD. Availability (NOFA) for Section 202 correction contains program ACTION: Notice. Supportive Housing for the Elderly for clarifications and a deadline change. Fiscal Year 2009. The technical The original deadline of November 16, corrections to the NOFA are available SUMMARY: HUD announces the 2009 for Section 811 Housing for on the Grants.gov Web site at http:// availability on its website of the Persons with Disabilities grant www.grants.gov. The CFDA number for applicant information, submission applications under this NOFA has been deadlines, funding criteria and other Section 202 Supportive Housing for the extended; the application deadline date requirements for HUD’s HOPE VI Main Elderly is 14.157. The technical is December 17, 2009. Street Grants program NOFA for correction contains program FY2009. Approximately $4 million is clarifications and a deadline change. FOR FURTHER INFORMATION CONTACT: For made available through this NOFA by The original deadline of November 13, questions concerning these technical the Department of Housing and Urban 2009 for Section 202 Supportive corrections, please contact Marvis Development Appropriations Act, 2009 Housing for the Elderly grant Hayward, Program Manager, Office of (Pub. L. 111–8, approved March 11, applications under this NOFA has been Housing Assistance and Grants 2009) for HUD’s HOPE VI Main Street extended; the application deadline date Administration, Office of Housing, Grants program. The notice providing is December 14, 2009. Department of Housing and Urban information regarding the application FOR FURTHER INFORMATION CONTACT: For Development, 451 Seventh Street, SW., process, funding criteria and eligibility questions concerning these technical Washington, DC 20410; telephone 202– requirements is available on the corrections, please contact Alicia 402–2255 (this is not a toll-free Grants.gov Web site at: https:// Anderson, Project Manager, Office of number); e-mail apply07.grants.gov/apply/ Housing Assistance and Grants [email protected]. Persons forms_apps_idx.html. A link to Administration, Office of Housing, with hearing or speech impairments Grants.gov is also available on the HUD Department of Housing and Urban Web site at http://www.hud.gov/offices/ Development, 451 Seventh Street, SW., may access these numbers via TTY by adm/grants/fundsavail.cfm. The Washington, DC 20410; telephone 202– calling the Federal Information Relay Catalogue of Federal Domestic 402–5787 (this is not a toll-free Service at 800–877–8339.
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Dated: November 12, 2009. MASSACHUSETTS DEPARTMENT OF THE INTERIOR David H. Stevens, Norfolk County Assistant Secretary for Housing—Federal National Park Service Housing Commissioner. Canton Corner Historic District, Roughly Washington St. from Pecunit St. to SW. of [FR Doc. E9–27678 Filed 11–17–09; 8:45 am] National Register of Historic Places; Dedham St., and Pleasant St. from Notification of Pending Nominations BILLING CODE 4210–67–P Washington St. to Reservoir Rd., Canton, and Related Actions 09000697, LISTED, 9/09/09 Nominations for the following DEPARTMENT OF THE INTERIOR Plymouth County properties being considered for listing Hatch Homestead and Mill Historic District, National Park Service or related actions in the National 385 Union St., Marshfield, 09000698, Register were received by the National National Register of Historic Places; LISTED, 9/11/09 Park Service before October 31, 2009. Weekly Listing of Historic Properties NEW YORK Pursuant to § 60.13 of 36 CFR part 60 written comments concerning the Pursuant to (36 CFR 60.13(b,c)) and Cayuga County significance of these properties under (36 CFR 63.5), this notice, through Hutchinson Homestead, 6080 Lake St., the National Register criteria for publication of the information included Cayuga, 09000478, LISTED, 9/09/09 evaluation may be forwarded by United herein, is to apprise the public as well Jefferson County States Postal Service, to the National as governmental agencies, associations Register of Historic Places, National and all other organizations and Hubbard, Hiram, House, 34237 NY 126, Park Service, 1849 C St., NW., 2280, individuals interested in historic Champion, 09000699, LISTED, 9/09/09 Washington, DC 20240; by all other preservation, of the properties added to, carriers, National Register of Historic or determined eligible for listing in, the Nassau County Places, National Park Service, 1201 Eye National Register of Historic Places from Manhasset Monthly Meeting of the Society of St. NW., 8th floor, Washington, DC September 7 to September 11, 2009. Friends, 1421 Northern Boulevard, For further information, please Manhasset, 09000700, LISTED, 9/09/09 20005; or by fax, 202–371–6447. Written or faxed comments should be submitted contact Edson Beall via: United States NORTH CAROLINA Postal Service mail, at the National by December 3, 2009. Register of Historic Places, 2280, Harnett County J. Paul Loether, National Park Service, 1849 C St., NW., Dunn Commercial Historic District, Roughly Chief, National Register of Historic Places/ Washington, DC 20240; in person (by Bounded by Harnett St., Cumberland St., National Historic Landmarks Program. appointment), 1201 Eye St., NW., 8th Clinton Ave. & Fayetteville Ave., Dunn, CALIFORNIA floor, Washington, DC 20005; by fax, 09000702, LISTED, 9/09/09 202–371–2229; by phone, 202–354– Amador County Rowan County 2255; or by e-mail, Kirkwood Lake Tract, 1/2 mile N. of CA 88 [email protected]. Griffith-Sowers House, 5050 Statesville on the Eldorado National Forest, Pioneer, Boulevard, Salisbury vicinity, 09000703, Dated: November 10, 2009. 09001054 LISTED, 9/09/09 J. Paul Loether, FLORIDA Chief, National Register of Historic Places/ NORTH DAKOTA Citrus County National Historic Landmarks Program. Grant County KEY: State, County, Property Name, Address/ Etna Turpentine Camp Archaeological Site, Boundary, City, Vicinity, Reference Evangelisch Lutheraner Dreieinigkeit Address Restricted, Inverness, 09001055 Gemeinde (Evangelical Lutheran Trinity Number, Action, Date, Multiple Name GEORGIA Church), 63rd St., SW section 15 Township ALABAMA 135 Range 90, New Leipzig vicinity, Carroll County Covington County 09000530, LISTED, 9/09/09 Bowdon Historic District, Roughly centered along GA 166 and GA 100, Bowdon, J.W. Shreve Addition Historic District, 115– OREGON 300 6th Ave, 302–425 College St., 403–505 09001056 E. Three Notch St., Andalusia, 09000692, Clackamas County Cherokee County LISTED, 9/09/09 Upper Sandy Guard Station Cabin, 4.5 mi. E. Ball Ground Historic District, Old Canton Rd. Mobile County of jct. FS Rds. 18 and 1825, Mt. Hood and GA 372, Ball Ground, 09001057 Garrison, Charles Denby, Sr., House, Co. Rd. National Forest, Government Camp 55, approx. 1 mi. NW. of jct. AL 158, vicinity, 09000705, LISTED, 9/09/09 ILLINOIS Prichard, 09000693, LISTED, 9/09/09 Multnomah County Jo Daviess County ARIZONA Hotel Alma, 1201–1217 SW Stark St., Chapman, John, Village Site, Address Restricted, Hanover, 09001058 Maricopa County Portland, 09000706, LISTED, 9/09/09 Town and Country Scottsdale Residential (Downtown Portland, Oregon MPS) LOUISIANA Historic District, Bounded by 72nd Place Memorial Coliseum, 1401 N. Wheeler Ave./ Washington Parish on the W., 74th St. on the E., Oak St. on 300 N. Winning St., Portland, 09000707, the N., and Monte Vista on the S., Moore, Bouey, Homestead, 19068 Moore Rd., Scottsdale, 09000694, LISTED, 9/08/09 LISTED, 9/10/09 Franklinton, 09001059 CONNECTICUT [FR Doc. E9–27620 Filed 11–17–09; 8:45 am] MARYLAND BILLING CODE P Windham County Anne Arundel County Quinebaug River Prehistoric Archeological Queenstown Rosenwald School, (Rosenwald District, Between Rt. 169 and the Schools of Anne Arundel County, Quinebaug River, Canterbury, 09000696, Maryland MPS) 430 Queenstown Rd., LISTED, 9/07/09 Severn, 09001060
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Baltimore County Union County INTERNATIONAL TRADE East Monument Historic District, N. All Souls Church, 724 Park Ave., Plainfield COMMISSION Washington St. on the W; Amtrak rail line City, 09001078 [Investigation No. 337–TA–621] on the N. to E. St.; S. to Monument and E. NEW YORK to Highland Ave.; Baltimore, 09001061 In the Matter of Certain Probe Card MICHIGAN Albany County Assemblies, Components Thereof and Baraga County Norman Vale, (Mexico MPS) 6030 Nott Rd., Certain Tested Dram and Nand Flash Guilderland, 09001079 Memory Devices and Products Dodd Ford Bridge, (Iron and Steel Bridges in Containing Same; Notice of Minnesota MPS) Co. Rd. 147 over Blue Cortland County Earth River, Shelby, 09001070 Commission Final Determination of No Stage Coach Inn, 2548 Clarks Corners Rd., Violation of Section 337; Termination Lake County Lapeer, 09001080 of Investigation Idlewild Historic District (Boundary Kings County Increase), Bounded generally by US 10 on AGENCY: U.S. International Trade the N.; 72nd St. on the S.; Nelson Rd. on Congregational Church of the Evangel, 1950 Commission. the E.; and extending W. of Forman Rd., Bedford Ave., Brooklyn, 09001081 ACTION: Notice. Yates, 09001062 Ocean Parkway Jewish Center, 550 Ocean Pkwy., Brooklyn, 09001082 SUMMARY: Notice is hereby given that Macomb County the U.S. International Trade Madison County Wolcott Mill, 63841 Wolcott Rd., Ray, Commission has determined that there 09001063 Chittenango Pottery, 11–13 Pottery St., is no violation of section 337 of the Manistee County Chittenango, 09001083 Tariff Act of 1930, as amended (19 Orchard Beach State Park, 2064 N. Lakeshore Nassau County U.S.C. 1337), in the above-captioned Rd., Manistee, 09001064 investigation. The Commission has DuPont-Guest Estate, S. side of Northern terminated the investigation. Presque Isle County Blvd. between Cotillion Ct. & DuPont Ct., FOR FURTHER INFORMATION CONTACT: Hoeft, P.H., State Park, 5001 US 23 N., Brookville, 09001084 Michael Liberman, Esq., Office of the Rogers, 09001065 New York County Onaway State Park, 3622 MI 211 N., North General Counsel, U.S. International Allis, 09001066 Westbeth, 55 Bethune St., New York, Trade Commission, 500 E Street, SW., 09001085 Washington, DC 20436, telephone (202) Washtenaw County 205–3116. Copies of non-confidential Queens County Detroit Financial District, Bounded by documents filed in connection with this Woodward & Jefferson and Lafayette & Church-in-the-Gardens, The, 50 Ascan Ave., investigation are or will be available for Washington Blvd., Detroit, 09001067 Forest Hills, 09001086 inspection during official business Wayne County Sullivan County hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. Koebel, Charles J. and Ingrid V. (Frendberg), Jewish Center of Lake Huntington, 13 Co. Rd. House, 203 Cloverly Rd., Grosse Pointe International Trade Commission, 500 E 116, Lake Huntington, 09001087 Farms, 09001068 Street, SW., Washington, DC 20436, Michigan Bell and Western Electric Wayne County telephone (202) 205–2000. General Warehouse, 882 Oakman Blvd., Detroit, Preston-Gaylord Cobblestone Farmhouse, information concerning the Commission 09001069 (Cobblestone Architecture of New York may also be obtained by accessing its NEBRASKA State MPS) 7563 Lake Rd., Sodus, Internet server at http://www.usitc.gov. The public record for this investigation Wayne County 09001088 may be viewed on the Commission’s Wayne Commercial Historic District, S. Main, Request for REMOVAL has been made for the following resources: electronic docket (EDIS) at http:// N. Main and 2nd St., Wayne, 09001071 edis.usitc.gov. Hearing-impaired NEW JERSEY KENTUCKY persons are advised that information on Bergen County Jefferson County this matter can be obtained by contacting the Commission’s TDD New York, Susquehanna & Western Railroad Meier, William G., Warehouse, (West terminal on (202) 205–1810. ALCO Type S–2 Locomotive #206, Louisville MRA) 2100 Rowan St., Maywood Station Museum, 271 Maywood Louisville, 83002704 SUPPLEMENTARY INFORMATION: This Ave., Maywood Borough, 09001072 National Tobacco Works Warehouse, (West investigation was instituted on December 19, 2007, based on a Essex County Louisville MRA) 101–113 S. 24th St., complaint filed by FormFactor, Inc. Anderson Park, SE. corner of Bellevue and Louisville, 83002712 [FR Doc. E9–27621 Filed 11–17–09; 8:45 am] (‘‘FormFactor’’) of Livermore, California. North Mountain Ave., Montclair, 09001073 The complaint alleged violations of Hunterdon County BILLING CODE P section 337 of the Tariff Act of 1930 (19 Case-Dvoor Farmstead, 111 Mine St., Raritan, U.S.C. 1337) in the importation into the 09001074 United States, the sale for importation, and the sale within the United States Morris County after importation of certain probe card Montville Schoolhouse, 6 Taylortown, assemblies, components thereof, and Montville, 09001075 certain tested DRAM and NAND flash Vreeland, Nicholas, Outkitchen, (Dutch Stone Houses in Montville MPS) 52 memory devices and products Jacksonville Rd., Towaco, Montville, containing same by reason of 09001076 infringement of certain claims of U.S. Whippany Burying Yard, NJ 10, Hanover, Patent Nos. 5,994,152 (‘‘the ’152 09001077 patent’’); 6,509,751 (‘‘the ’751 patent’’);
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6,615,485; 6,624,648 (‘‘the ’648 patent’’); substituting the following: ‘‘Respondent copy of this ICR, with applicable 7,168,162 (‘‘the ’162 patent’’); and Micronics’ accused products do not supporting documentation; including 7,225,538. The complaint named infringe claims 1–3, 12, 24, and 25 of among other things a description of the Micronics Japan Co., Ltd.; MJC U.S. Patent No. 6,509,751 in violation of likely respondents, proposed frequency Electronics Corp.; Phicom Corporation; 35 U.S.C. 271(a). Respondent Phicom’s of response, and estimated total burden and Phiam Corporation as respondents (old) Type B and Type C accused may be obtained from the RegInfo.gov (collectively, ‘‘Respondents’’). products infringe claims 1–3, 12, 24, Web site at http://www.reginfo.gov/ Subsequently, the ’162 patent was and 25 of U.S. Patent No. 6,509,751 in public/do/PRAMain or by contacting terminated from the investigation. violation of 35 U.S.C. 271(a); Phicom’s Darrin King on 202–693–4129 (this is On December 5, 2008, respondents new Type B and Type C accused not a toll-free number)/e-mail: Phicom Corp. and Phiam Corp., products do not infringe.’’ [email protected]. Interested (collectively, ‘‘Phicom’’) jointly filed a (2) With respect to the ’152 patent: parties are encouraged to send motion for partial summary (a) to strike the ID’s statement ‘‘Since comments to the Office of Information determination that claims 20 and 34 of three bases for no violation of claim 21 and Regulatory Affairs, Attn: OMB Desk the ’648 patent are invalid as indefinite have been determined, no analysis of Officer for the Department of Labor— under 35 U.S.C. 112. On February 11, the invalidity arguments related to ETA, Office of Management and Budget, 2009, the ALJ granted the motion in an anticipation and obviousness of the Room 10235, Washington, DC 20503, ID (Order No. 46). The ID determined dependent claims will be made,’’ see ID Telephone: 202–395–7316/Fax: 202– that claims 20 and 34, and any asserted at 191, and to take no position with 395–5806 (these are not toll-free claims depending therefrom, are respect to the validity of the dependent numbers), E-mail: invalid. Complainant FormFactor filed a claims of the ’152 patent. [email protected]. petition for review of Order No. 46, (3) To affirm and adopt the ALJ’s Comments and questions about the ICR which Respondents and the other findings contained in the final ID listed below should be received 5 days Commission Investigative Attorney under review except insofar as they are prior to the requested OMB approval (‘‘IA’’) opposed. On March 11, 2009, the inconsistent with the Commission date. Commission determined to review Opinion to be issued later. The OMB is particularly interested in Order No.46. The Commission also determined to comments which: The evidentiary hearing in this affirm ALJ Order No. 46 with certain • Evaluate whether the proposed investigation was held from February modifications as will be detailed in the collection of information is necessary 24, 2009, through March 6, 2009. On Commission’s Opinion. for the proper performance of the June 29, 2009, the ALJ issued an Initial The Commission has determined that functions of the agency, including Determination on Violation of Section there is no violation of section 337 in whether the information will have 337 and Recommended Determination this investigation, and has terminated practical utility; • on Remedy and Bond, finding no the investigation. Evaluate the accuracy of the violation of section 337. All parties to The authority for the Commission’s agency’s estimate of the burden of the this investigation, including the IA, determination is contained in section proposed collection of information, filed timely petitions for review of 337 of the Tariff Act of 1930, as including the validity of the various portions of the final ID, as well amended (19 U.S.C. 1337), and sections methodology and assumptions used; • as timely responses to the petitions. 210.41–.42, 210.50 of the Commission’s Enhance the quality, utility, and On September 17, 2009, the Rules of Practice and Procedure (19 CFR clarify of the information to be Commission determined to review the 210.41–.42, 210.50). collected; and final ID in part, and issued a Notice to • Minimize the burden of the that effect. 74 FR 47822 (September 17, Issued: November 12, 2009. collection of information on those who 2009). In the Notice, the Commission set By order of the Commission. are to respond, including through the a schedule for the filing of written Marilyn R. Abbott, use of appropriate automated, submissions on the issues under review, Secretary to the Commission. electronic, mechanical, or other including certain questions posed by the [FR Doc. E9–27612 Filed 11–17–09; 8:45 am] technological collection techniques or Commission, and on remedy, the public BILLING CODE 7020–02–P other forms of information technology, interest, and bonding. The parties have e.g., permitting electronic submissions briefed, with initial and reply of responses. submissions, the issues under review DEPARTMENT OF LABOR Agency: Employment and Training and the issues of remedy, the public Administration. interest, and bonding. Office of the Secretary Title of Collection: Jobs for America’s On review, the Commission has Job Seekers Challenge. determined as follows. Submission for OMB Emergency OMB Control Number: Pending. (1) With respect to the ’751 patent: Review: Comment Request Frequency of Collection: This is a one- (a) to reverse the ALJ’s determination time data collection. that Japanese Patent Application November 12, 2009. Affected Public: State Workforce Publication H10–31034 to Amamiya et The Department of Labor has Agencies, businesses, non-profit al. (RX–166) does not anticipate the submitted the following information organizations, other State government asserted claims of the ’751 patent under collection request (ICR), utilizing entities, workforce investment boards, 35 U.S.C. 102; emergency review procedures, to the One Stop Career Center staff, and the (b) to reverse in part the ID’s Office of Management and Budget public. conclusion that, inter alia, Phicom’s (OMB) for review and clearance in Estimated Time per Respondent: A accused products do not infringe claims accordance with the Paperwork maximum of 10 minutes per Phase One 1–3, 12, 24, and 25 of U.S. Patent No. Reduction Act of 1995 (Pub. L. 104–13, respondent, of whom 1,000 are 6,509,751, see ID at 197, and, 44 U.S.C. Chapter 35) and 5 CFR estimated to respond. For Phase Two, a accordingly, to modify the ID’s 1320.13. OMB approval has been maximum of 10,000 respondents are conclusion of law at issue by requested by November 23, 2009. A estimated (crowdsourcing portion) at 10
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minutes total for an estimated rating of tasks in a reasonable amount of time, by November 30, 2009 would waste two tools each. and the level of satisfaction the user felt. federal Recovery Act and State Total Estimated Number of Phase 3 will begin on January 18, resources. Many States and local areas Respondents: A maximum of 11,000 2010. In this final phase, DOL, ETA, and are individually searching for job respondents are expected. the White House will communicate the matching and job search solutions to Total Estimated Annualized Burden top tools in each category with the meet the significantly increased number Hours: 1,833 hours. entire workforce development of job seekers in need of assistance in Total Estimated Annualized Cost community and job seekers through a One Stop Career Centers nationwide as Burden: $0. variety of mediums, including: a result of the historic downturn in the Description: (1) Posting an announcement of the nation’s economy. The U.S. Department of Labor’s (DOL) top ranking tools on key Web sites Employment and Training including; Darrin A. King, Administration (ETA), in conjunction a. DOL.gov Departmental Clearance Officer. with the White House and IdeaScale, is b. Doleta.gov [FR Doc. E9–27697 Filed 11–17–09; 8:45 am] launching the Jobs for America’s Job c. White House OSTP blog BILLING CODE 4510–FN–P Seekers Challenge. Using an online d. Workforce3one.org platform designed by IdeaScale, the e. Other sites Challenge will allow toolmakers and (2) Highlighting free tools on ETA’s DEPARTMENT OF LABOR developers to present their free online http://www.CareerOneStop.org portal, job tools to workforce development which already houses a variety of tools Employment and Training experts and jobseekers for discussion, for the workforce system; Administration rating, and voting. The tools that receive (3) Hosting Webinars featuring the top Request for Certification of the most votes will be shared broadly ranking tools on Workforce3one.org; Compliance—Rural Industrialization with the workforce investment system (4) Utilizing other communication Loan and Grant Program and jobseekers, and listed on outlets such as national associations and government Web sites like http:// Intergovernmental organizations like the AGENCY: Employment and Training www.CareerOneStop.org, http:// National Association of State Workforce Administration, Labor. www.Workforce3One.org, and http:// Agencies, the National Association of ACTION: Notice. www.DOLETA.gov. This is not an Workforce Boards, the National opportunity to apply for government Governor’s Association, the National SUMMARY: The Employment and funding and ETA will not make any Association of Counties, and the Training Administration is issuing this funds available to any party pursuant to Association of Community Colleges. notice to announce the receipt of a this announcement. As a result of the Challenge, the ‘‘Certification of Non-Relocation and The Challenge will consist of three workforce development system will Market and Capacity Information phases. Phase 1 will run from November quickly boost its capacity to meet the Report’’ (Form 4279–2) for the 30, 2009 to December 18, 2009. In this job information needs of the following: phase, toolmakers and developers will significantly increased number of Applicant/Location: Custom Poultry submit information on their free online customers requiring service in the Processing, LLC/West Union, Iowa. job search and job matching tools. These current economic recovery effort. Principal Product/Purpose: The loan, tools must be free to the job seeker, but guarantee, or grant application is to Why Are We Requesting Emergency enable a new business venture to can be licensed by the workforce system Processing? at the State or local level provided the acquire and alter an existing building companies offer a short-term demo or In today’s tight employment market for poultry processing and also purchase other platform that allows the tools to be that has experienced a 10.2 percent and install poultry processing reviewed free of charge. Submissions unemployment rate that is the highest in equipment. The NAICS industry code will be accepted from businesses, 26 years, the publicly funded workforce for this enterprise is: 311615 Poultry nonprofits organizations, entrepreneurs, investment system has a major Processing. and State and local workforce agencies. responsibility to maximize unemployed DATES: All interested parties may submit The tools will be organized into one or workers’ opportunities for rapid comments in writing no later than more of the following categories: reemployment by quickly connecting December 2, 2009. Copies of adverse • General job boards, listing sites, and them to the full scope of available jobs. comments received will be forwarded to aggregators We know the workforce system is the applicant noted above. • working hard to connect workforce Niche job boards ADDRESSES: Address all comments • system customers to the best job search Career advancement tools concerning this notice to Anthony D. • resources available. However, as a result Web based career exploration sites Dais, U.S. Department of Labor, • of technological innovations, new job Web 2.0/social media sites Employment and Training search tools have been launched and specializing in job searches or job Administration, 200 Constitution new tools are emerging daily that help postings Avenue, NW., Room S–4231, • Other job tools job seekers find jobs and target their Washington, DC 20210; or e-mail Phase 2 will run from January 4 to search to the most relevant employment [email protected]; or transmit via January 15, 2010. During this phase, opportunities. workforce development experts and job Expedited or Emergency approval of fax (202) 693–3015 (this is not a toll-free seekers will review and vote on the this data collection will enable the number). submitted job search and matching Department of Labor (DOL), FOR FURTHER INFORMATION CONTACT: tools. Reviewers will be encouraged to Employment and Training Anthony D. Dais, at telephone number consider a tool’s usability based on how Administration (ETA), and the White (202) 693–2784 (this is not a toll-free effective the tool is in providing House to respond aggressively to the number). accurate results, how efficient it is in record unemployment rates. Failure to SUPPLEMENTARY INFORMATION: Section completing job search and matching start the Challenge and do the collection 188 of the Consolidated Farm and Rural
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Development Act of 1972, as established 623220 Residential Mental Health and NATIONAL AERONAUTICS AND under 29 CFR Part 75, authorizes the Substance Abuse Facilities. SPACE ADMINISTRATION United States Department of Agriculture DATES: All interested parties may submit to make or guarantee loans or grants to [Notice (09–097)] finance industrial and business comments in writing no later than December 2, 2009. Copies of adverse activities in rural areas. The Secretary of NASA Advisory Council; Science Labor must review the application for comments received will be forwarded to Committee; Planetary Science financial assistance for the purpose of the applicant noted above. Subcommittee; Meeting. certifying to the Secretary of Agriculture ADDRESSES: Address all comments AGENCY: that the assistance is not calculated, or concerning this notice to Anthony D. National Aeronautics and Space Administration. likely, to result in: (a) A transfer of any Dais, U.S. Department of Labor, employment or business activity from Employment and Training ACTION: Notice of meeting. one area to another by the loan Administration, 200 Constitution SUMMARY: applicant’s business operation; or, (b) Avenue, NW., Room S–4231, The National Aeronautics and An increase in the production of goods, Space Administration (NASA) Washington, DC 20210; or e-mail materials, services, or facilities in an announces a meeting of the Planetary [email protected]; or transmit via area where there is not sufficient Science Subcommittee of the NASA demand to employ the efficient capacity fax (202) 693–3015 (this is not a toll-free Advisory Council (NAC). This of existing competitive enterprises number). Subcommittee reports to the Science unless the financial assistance will not FOR FURTHER INFORMATION CONTACT: Committee of the NAC. The Meeting have an adverse impact on existing Anthony D. Dais, at telephone number will be held for the purpose of soliciting competitive enterprises in the area. The (202) 693–2784 (this is not a toll-free from the scientific community and other Employment and Training number). person’s scientific and technical Administration within the Department information relevant to program of Labor is responsible for the review SUPPLEMENTARY INFORMATION: Section planning. and certification process. Comments 188 of the Consolidated Farm and Rural DATES: Thursday, December 3, 2009, should address the two bases for Development Act of 1972, as established 8:30 a.m. to 5:30 p.m., and Friday, certification and, if possible, provide under 29 CFR Part 75, authorizes the December 4, 2009, 8:30 a.m. to 12:30 data to assist in the analysis of these United States Department of Agriculture p.m. MST. issues. to make or guarantee loans or grants to ADDRESSES: University of Colorado, Signed at Washington, DC, this 10th of finance industrial and business November 2009. Laboratory for Atmospheric and Space activities in rural areas. The Secretary of Physics, Conference Room A200, 1234 Jane Oates, Labor must review the application for Innovation Drive, Boulder, CO 80303. Assistant Secretary for Employment and financial assistance for the purpose of FOR FURTHER INFORMATION CONTACT: Training. certifying to the Secretary of Agriculture Ms. Marian Norris, Science Mission [FR Doc. E9–27610 Filed 11–17–09; 8:45 am] that the assistance is not calculated, or Directorate, NASA Headquarters, BILLING CODE 4510–FN–P likely, to result in: (a) A transfer of any Washington, DC 20546, (202) 358–4452, employment or business activity from fax (202) 358–4118, or one area to another by the loan DEPARTMENT OF LABOR [email protected]. applicant’s business operation; or, (b) SUPPLEMENTARY INFORMATION: Employment and Training An increase in the production of goods, The Administration materials, services, or facilities in an meeting will be open to the public up area where there is not sufficient to the capacity of the room. The agenda Request for Certification of demand to employ the efficient capacity for the meeting includes the following Compliance—Rural Industrialization of existing competitive enterprises topics: Loan and Grant Program unless the financial assistance will not —Planetary Science Division Update have an adverse impact on existing —Mars Exploration Program Update AGENCY: Employment and Training Administration, Labor. competitive enterprises in the area. The —Analysis Group Reports Employment and Training ACTION: Notice. —Review and Assessment of Current Administration within the Department Process for Adding Co-Investigators SUMMARY: The Employment and of Labor is responsible for the review and Interdisciplinary Scientists to Training Administration is issuing this and certification process. Comments Long-Duration Missions notice to announce the receipt of a should address the two bases for —Status and Future of the Planetary ‘‘Certification of Non-Relocation and certification and, if possible, provide Data System Market and Capacity Information data to assist in the analysis of these It is imperative that the meeting be Report’’ (Form 4279–2) for the issues. held on these dates to accommodate the following: scheduling priorities of the key Applicant/Location: Dave’s Place, Signed at Washington, DC, this 10th of November 2009. participants. Attendees will be LLC/Keokuk, Iowa. requested to sign a register. Principal Product/Purpose: The loan, Jane Oates, guarantee, or grant application is to Assistant Secretary for Employment and Dated: November 12, 2009. enable a new business venture to Training. P. Diane Rausch, renovate and convert a former nursing [FR Doc. E9–27611 Filed 11–17–09; 8:45 am] Advisory Committee Management Officer, care facility into one that provides BILLING CODE 4510–FN–P National Aeronautics and Space intermediate care and rehabilitation for Administration and Space Administration. persons with mental illness. The NAICS [FR Doc. E9–27626 Filed 11–17–09; 8:45 am] industry code for this enterprise is: BILLING CODE P
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NUCLEAR REGULATORY completed initial decommissioning of ventilation equipment, and 4 to 6 inches COMMISSION the Facility (excluding Building 150) in of soil adjacent to the building were Bethesda, Maryland, in 2000. The removed by Navy personnel and [NRC–2009–0504; Docket No. 030–29462] NMRC was authorized to use licensed disposed of as radioactive waste. In Notice of Availability of Environmental materials under Naval Radioactive 2002, following the initial Assessment and Finding of No Materials Permit 19–32398–41NP in decommissioning of the NMRC, the Significant Impact Related to the accordance with the Navy’s Master Navy initiated additional Approval for the Department of the Materials License No. 45–23645–01NA. decommissioning of Building 150 and Navy To Issue an Amendment to a In the conduct of that initial the underground storage tanks (UST). Materials Permit for the Unrestricted decommissioning action the Navy Remediation activities included removal Release of Building 150 at the Naval requested authorization to postpone of the USTs, removal of contaminated Medical Research Center in Bethesda, decommissioning activities at Building soil adjacent to Building 150, scabbling Maryland, Under Byproduct Materials 150. Additionally, two underground of concrete surfaces within Building License No. 45–23645–01NA storage tanks (USTs) were discovered 150, and removal of rubble and drain during the decommissioning of the lines within the Facility. AGENCY: Nuclear Regulatory NMRC, and remediation of the USTs Need for the Proposed Action Commission. were added to the Navy’s ACTION: Issuance of Environmental decommissioning work plan for The Navy is requesting approval of Assessment and Finding of No Building 150. this permitting action because it has Significant Impact for Permit Building 150 was constructed in the ceased conducting licensed activities at Amendment. early 1950s as a facility for the the Facility, and seeks the unrestricted irradiation of animals to determine the use of its Facility and the termination of FOR FURTHER INFORMATION CONTACT: effects of ionizing radiation on the organ the permit. NRC is fulfilling its Orysia Masnyk Bailey, Health Physicist, and cellular systems. The radiation responsibilities under the Atomic Decommissioning Branch, Division of source used for these studies consisted Energy Act to make a timely decision on Nuclear Materials Safety, Region I, 475 of 2,500 curies of cobalt-60 in ceramic a proposed license amendment for Allendale Road, King of Prussia, slugs arranged in circles. AEC License decommissioning that ensures Pennsylvania 19406; telephone (864) No. 19–02891–03 was issued on October protection of the public health and 427–1032; fax number (610) 680–3497; 2, 1957, authorizing the use of cobalt-60 safety. or by e-mail: for this research. License No. 19–02891– Environmental Impacts of the Proposed [email protected]. 03 expired on March 31, 1963. Action Building 150 is located on the SUPPLEMENTARY INFORMATION: grounds of the NMRC. The Facility The historical review of licensed I. Introduction consists of a 1,100 square foot building, activities conducted at the Facility with approximately one foot thick shows that such activities involved use The U.S. Nuclear Regulatory of the following radionuclides with half- Commission (NRC) is considering reinforced concrete walls. The building was divided into two radiation exposure lives greater than 120 days in unsealed allowing the Department of the Navy form: cobalt-60. The Navy conducted a (Navy) to issue an amendment to a rooms and a control room. The building is covered with a 10 inch thick overhead final status survey in January 2004. This materials permit in accordance with survey covered the areas of use at the NRC Byproduct Materials License No. reinforced concrete slab. The control room is separated from the two Facility. The Navy elected to 45–23645–01NA. The NRC approval radiation rooms by a 3 feet 10 inch thick demonstrate compliance with the would authorize the Navy to release, for radiation shield, constructed of radiological criteria for unrestricted unrestricted use, Building 150 at the reinforced barite concrete which is 45 release as specified in 10 CFR 20.1402 Naval Medical Research Center in pounds heavier per cubic foot then by using the screening approach Bethesda, Maryland. The Navy regular reinforced concrete. Radiation described in NUREG–1757, requested this action by letter July 11, room 1, where the sources were stored, ‘‘Consolidated NMSS Decommissioning 2008. The NRC has prepared an was further shielded by a 3 foot thick Guidance,’’ Volume 2. The Licensee Environmental Assessment (EA) in barite concrete wall. used the radionuclide-specific derived support of this proposed action in Several minor contamination concentration guideline levels (DCGLs), accordance with the requirements of incidents occurred during routine developed there by the NRC, which Title 10, Code of Federal Regulations maintenance between 1951 and 1962, comply with the dose criterion in 10 (CFR), Part 51 (10 CFR part 51). Based probably caused by cracks in the CFR 20.1402. These DCGLs define the on the EA, the NRC has concluded that ceramic slugs. In April 1962, one of the maximum amount of residual a Finding of No Significant Impact NMRC employees was found to be radioactivity on building surfaces, (FONSI) is appropriate with respect to internally contaminated with cobalt-60 equipment, and materials, and in soils, the proposed action. The proposed during routine internal personnel that will satisfy the NRC requirements action will be taken following the monitoring. Investigation disclosed that in subpart E of 10 CFR part 20 for publication of this FONSI and EA in the widespread contamination was present unrestricted release. The Navy’s final Federal Register. on the ground surrounding the building. status survey results were below these II. Environmental Assessment The cause of the contamination was DCGLs and are in compliance with the determined to be a failure of the source As Low As Reasonably Achievable Identification of Proposed Action capsule seals. Building 150 and (ALARA) requirement of 10 CFR The proposed action would approve surrounding grounds were originally 20.1402. The NRC thus finds that the the Navy’s July 11, 2008, request to decommissioned in 1963. The sources Navy’s final status survey results are release Building 150 at the Naval were transferred by Atlantic Research acceptable. Medical Research Center (NMRC) in Corporation, under AEC License No. Based on its review the staff has Bethesda, Maryland (the Facility) for 45–02808–02, to Oak Ridge National determined that the affected unrestricted release. The Navy Laboratory. Building 150 internals, roof, environment and any environmental
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impacts associated with the proposed the proposed action will not Licensing and Related Regulatory action are bounded by the impacts significantly impact the quality of the Functions;’’ evaluated by the ‘‘Generic human environment, the NRC staff 4. NUREG–1496, ‘‘Generic Environmental Impact Statement in concludes that the proposed action is Environmental Impact Statement in Support of Rulemaking on Radiological the preferred alternative. Support of Rulemaking on Radiological Criteria for License Termination of Agencies and Persons Consulted Criteria for License Termination of NRC- NRC–Licensed Nuclear Facilities’’ Licensed Nuclear Facilities;’’ (NUREG–1496) Volumes 1–3 NRC provided a draft of this 5. NRC License No. 45–23645–01NA (ML042310492, ML042320379, and Environmental Assessment to the inspection and licensing records; ML042330385). The staff finds there Radiological Health Program in the Air 6. NMRC Historical Site Assessment were no significant environmental and Radiation Management (HAS) Volume I of II, dated June 15, impacts from the use of radioactive Administration of the Maryland 1999 (ML082280739); material at the Facility. The NRC staff Department of the Environment for 7. NMRC Historical Site Assessment reviewed the docket file records and the review on August 13, 2009. On (HAS) Volume II of II, dated June 15, final status survey report to identify any September 14, the State of Maryland 1999 (ML082280809); non-radiological hazards that may have responded by email. The State agreed 8. NMRC Radiological impacted the environment surrounding with the conclusions of the EA, and Decontamination and Decommissioning the Facility. No such hazards or impacts otherwise had no comments. (D&D) Plan, Revision 1, dated August to the environment were identified. The The NRC staff has determined that the 17,1999 (ML082280784 and NRC has identified no other radiological proposed action is of a procedural ML082280814); or non-radiological activities in the area nature, and will not affect listed species that could result in cumulative 9. Radiological Decontamination and or critical habitat. Therefore, no further Decommissioning (D&D) Final Status environmental impacts. consultation is required under Section 7 The NRC staff finds that the proposed Survey Report, dated April 2000 of the Endangered Species Act. The (ML082280117 and ML082280147); release of the Facility for unrestricted NRC staff has also determined that the use and the termination of the Navy’s 10. Radiological Decontamination and proposed action is not the type of Decommissioning (D&D) Final Status materials permit is in compliance with activity that has the potential to cause 10 CFR 20.1402. Based on its review, Survey Report, dated June 16, 2000 effects on historic properties. Therefore, (ML082280738 and ML082280755); the staff considered the impact of the no further consultation is required 11. Radiological Decontamination and residual radioactivity at the Facility and under Section 106 of the National Decommissioning (D&D) Final Status concluded that the proposed action will Historic Preservation Act. not have a significant effect on the Survey Report, dated August 2000 quality of the human environment. III. Finding of No Significant Impact (ML082280309, ML082280317, ML082280334, and ML082280287); Environmental Impacts of the The NRC staff has prepared this EA in 12. NRC letter dated February 29, Alternatives to the Proposed Action support of the proposed action. On the basis of this EA, the NRC finds that 2000, ‘‘Decommissioning Plans for Due to the largely administrative there are no significant environmental Naval Medical Research Center’’ nature of the proposed action, its impacts from the proposed action, and (ML003687082); environmental impacts are small. that preparation of an environmental 13. Department of the Navy Letter Therefore, the only alternative the staff impact statement is not warranted. dated July 6, 2005, ‘‘Decommissioning considered is the no-action alternative, Accordingly, the NRC has determined of the Former Naval Medical Research under which the staff would leave that a Finding of No Significant Impact Center (NMRC), Bethesda, MD’’ things as they are by simply denying the is appropriate. (ML051940414); amendment request. This no-action 14. Department of the Navy letter alternative is not feasible because it IV. Further Information dated October 22, 2007, ‘‘Building 150 conflicts with 10 CFR 30.36(d), Documents related to this action, and Underground Storage Tank requiring that decommissioning of including the application for license Decommissioning Project, National byproduct material facilities be amendment and supporting Naval Medical Center, Bethesda, MD’’ completed and approved by the NRC documentation, are available (ML073060430); and after licensed activities cease. The electronically at the NRC’s Electronic 15. Department of the Navy Letter NRC’s analysis of the Navy’s final status Reading Room at http://www.nrc.gov/ dated July 11, 2008, ‘‘Naval Medical survey data confirmed that the Facility reading-rm/adams.html. From this site, Research Center (NMRC), Bethesda meets the requirements of 10 CFR you can access the NRC’s Agencywide Decommissioning Documentation’’ 20.1402 for unrestricted release and for Document Access and Management (ML082270292). permit termination. Additionally, System (ADAMS), which provides text denying the Navy’s request to terminate If you do not have access to ADAMS, and image files of NRC’s public its permit would result in no change in or if there are problems in accessing the documents. The documents related to current environmental impacts. The documents located in ADAMS, contact this action are listed below, along with environmental impacts of the proposed the NRC Public Document Room (PDR) their ADAMS accession numbers. action and the no-action alternative are Reference staff at 1–800–397–4209, 301– therefore similar, and the no-action 1. NUREG–1757, ‘‘consolidated NMSS 415–4737, or by e-mail to alternative is accordingly not further Decommissioning Guidance;’’ [email protected]. These documents considered. 2. Title 10, Code of Federal may also be viewed electronically on Regulations, Part 20, Subpart E, the public computers located at the Conclusion ‘‘Radiological Criteria for License NRC’s PDR, O 1 F21, One White Flint The NRC staff has concluded that the Termination;’’ North, 11555 Rockville Pike, Rockville, proposed action is consistent with the 3. Title 10, Code of Federal MD 20852. The PDR reproduction NRC’s unrestricted release criteria Regulations, Part 51, ‘‘Environmental contractor will copy documents for a specified in 10 CFR 20.1402. Because Protection Regulations for Domestic fee.
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Dated at Region I, 475 Allendale PA, King subsidiary of Grail Partners, LLC, is the Additional information regarding the of Prussia, PA this 10th day of November Fund’s investment manager, and Fund, the Shares, the Fund’s investment 2009. American Beacon Advisors, Inc. objective (including other non-primary For the Nuclear Regulatory Commission. (‘‘ABA’’) is the Fund’s sub-adviser.6 In investments and investments permitted James P. Dwyer, addition, Lazard Asset Management for temporary defensive purposes), Chief, Commercial & R&D Branch, Division LLC, Templeton Investment Counsel, investment strategies, policies, and of Nuclear Materials Safety, Region I. LLC, and The Boston Company Asset restrictions, risks, fees and expenses, [FR Doc. E9–27651 Filed 11–17–09; 8:45 am] Management, LLC (collectively, ‘‘Other creations and redemptions of Shares, BILLING CODE 7590–01–P Sub-Advisers’’) each is a sub-adviser to availability of information, trading rules the Fund and each is affiliated with a and halts, and surveillance procedures, broker-dealer. The Exchange states that among other things, can be found in the SECURITIES AND EXCHANGE the Shares will conform to the initial Registration Statement and in the COMMISSION and continued listing criteria under Notice, as applicable.9 NYSE Arca Equities Rule 8.600 and that II. Discussion and Commission’s [Release No. 34–60975; File No. SR– the Fund will be in compliance with Findings NYSEArca–2009–83] Rule 10A–3 under the Act.7 The Commission has carefully Self-Regulatory Organizations; NYSE The Fund’s investment objective is reviewed the proposed rule change and Arca, Inc.; Order Granting Approval of long-term capital appreciation. It seeks finds that it is consistent with the a Proposed Rule Change To List and to achieve its investment objective by requirements of Section 6 of the Act 10 Trade Shares of the Grail American investing at least 80% of its net assets and the rules and regulations Beacon International Equity ETF (plus the amount of any borrowings for investment purposes) in common stocks thereunder applicable to a national November 10, 2009. and securities convertible into common securities exchange.11 In particular, the Commission finds that the proposal is On September 18, 2009, NYSE Arca, stocks of issuers based in at least three consistent with Section 6(b)(5) of the Inc. (‘‘NYSE Arca’’ or ‘‘Exchange’’), different countries located outside the Act,12 through its wholly owned subsidiary, United States. The Fund will primarily which requires, among other NYSE Arca Equities, Inc. (‘‘NYSE Arca hold securities of large capitalization things, that the Exchange’s rules be 8 Equities’’), filed with the Securities and companies that have last sale reporting designed to promote just and equitable Exchange Commission (‘‘Commission’’), in the countries in which it invests and principles of trade, to remove pursuant to Section 19(b)(1) of the will primarily invest in countries in the impediments to and perfect the Securities Exchange Act of 1934 Morgan Stanley Capital International mechanism of a free and open market and a national market system, and, in (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 a Europe Australasia Far East Index. general, to protect investors and the proposed rule change to list and trade Creations and redemptions of Fund public interest. shares (‘‘Shares’’) of the Grail American Shares will generally be in-kind, with a The Commission finds that the Beacon International Equity ETF specified cash component. Authorized proposal to list and trade the Shares on (‘‘Fund’’) under NYSE Arca Equities Participants or the investors on whose the Exchange is consistent with Section Rule 8.600. The proposed rule change behalf the Authorized Participants are 11A(a)(1)(C)(iii) of the Act, which sets was published in the Federal Register acting (‘‘Investors’’), however, may forth Congress’ finding that it is in the on October 9, 2009.3 The Commission deliver in connection with creations or public interest and appropriate for the received no comments on the proposal. receive in connection with redemptions protection of investors and the This order grants approval of the cash in lieu of one or more in-kind maintenance of fair and orderly markets proposed rule change. securities. Specifically, in connection with creations or redemptions, an to assure the availability to brokers, I. Description of the Proposal Authorized Participant or Investor may dealers and investors of information The Exchange proposes to list and transact in cash, in whole or in part, at with respect to quotations for and trade the Shares of the Fund pursuant the sole discretion of the Fund; transactions in securities. Quotation and to NYSE Arca Equities Rule 8.600, provided, however, that the cash last sale information for the Shares will which governs the listing of Managed amount delivered or received shall not be available via the Consolidated Tape Fund Shares.4 The Shares will be exceed 10% of the value of the in-kind Association (‘‘CTA’’) high-speed line, offered by Grail Advisors’ ETF Trust creation or redemption basket, unless and the Exchange will disseminate the (‘‘Trust’’), a statutory trust organized the Authorized Participant or Investor is Portfolio Indicative Value (‘‘PIV’’) at under the laws of the State of Delaware subject to legal restrictions with respect least every 15 seconds during the Core and registered with the Commission as to delivery or receipt of one or more Trading Session through the facilities of an open-end management investment securities in the in-kind creation or the CTA. In addition, the Fund will company.5 Grail Advisors, LLC redemption basket, or the Fund is in a make available on its Web site on each (‘‘Manager’’), a majority owned temporary defensive position. The business day before commencement of creation unit size for the Fund will be trading of the Core Trading Session the 13 1 15 U.S.C. 78s(b)(1). 50,000 Shares. Disclosed Portfolio that will form the 2 17 CFR 240.19b–4. 3 See Securities Exchange Act Release No. 60773 6 The Exchange represents that, while ABA is not 9 See supra notes 3 and 5. (October 2, 2009), 74 FR 52288 (‘‘Notice’’). affiliated with a broker-dealer, the Manager is 10 15 U.S.C. 78f. 4 See NYSE Arca Equities Rule 8.600. affiliated with a broker-dealer, Grail Securities, 11 In approving this proposed rule change the 5 The Exchange states that the Trust is registered LLC. Commission has considered the proposed rule’s under the Investment Company Act of 1940 (‘‘1940 7 17 CFR 240.10A–3. impact on efficiency, competition, and capital Act’’) and that, on April 29, 2009, the Trust filed 8 The Fund considers companies with market formation. See 15 U.S.C. 78c(f). with the Commission pre-effective Amendment No. capitalizations of more than $1 billion to be large 12 17 U.S.C. 78f(b)(5). 3 to its registration statement on Form N–1A under capitalization companies. Thus, at least 50% of the 13 The Exchange represents that the Fund will the Securities Act of 1933 (15 U.S.C. 77a) and under Fund’s assets invested in securities of companies disclose on the Fund’s Web site for each portfolio the 1940 Act relating to the Fund (File Nos. 333– will be in companies with market capitalizations of security or other financial instrument of the Fund 148082 and 811–22154) (‘‘Registration Statement’’). more than $1 billion. the following information: Ticker symbol (if
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basis for its calculation of the net asset each sub-adviser to the Fund has such situations are detected, value (‘‘NAV’’), which will be represented that they have implemented surveillance analysis follows and determined as of the close of the regular a ‘‘fire wall’’ between it and its investigations are opened, where trading session on the New York Stock respective broker-dealer affiliate(s) with appropriate, to review the behavior of Exchange (ordinarily 4 p.m. Eastern respect to access to information all relevant parties for all relevant Time) on each business day. In addition, concerning the composition and/or trading violations. The Exchange may a basket composition file, which changes to the Fund’s portfolio.15 obtain information via the Intermarket includes the security names and share Finally, the Commission notes that the Surveillance Group (‘‘ISG’’) from other quantities required to be delivered in Reporting Authority that provides the exchanges that are members of ISG.17 In exchange for Fund Shares, together with Disclosed Portfolio must implement and addition, the Exchange also has a estimates and actual cash components, maintain, or be subject to, procedures general policy prohibiting the will be publicly disseminated daily designed to prevent the use and distribution of material, non-public prior to the opening of the New York dissemination of material non-public information by its employees. Stock Exchange via the National information regarding the actual (3) Prior to the commencement of Securities Clearing Corporation. The components of the portfolio.16 trading, the Exchange will inform its Fund’s Web site will also include The Exchange has represented that ETP Holders in an Information Bulletin additional quantitative information the Shares are equity securities subject of the special characteristics and risks updated on a daily basis relating to to the Exchange’s rules governing the associated with trading the Shares. trading volume, prices, and NAV. trading of equity securities and will Specifically, the Information Circular Information regarding the market price trade on the NYSE Arca Marketplace will discuss the following: (a) The and trading volume of the Shares will be from 4 a.m. to 8 p.m. Eastern Time in procedures for purchases and continually available on a real-time accordance with NYSE Arca Equities redemptions of Shares and that Shares basis throughout the day via electronic Rule 7.34 (Opening, Core, and Late are not individually redeemable; (b) services, and the previous day’s closing Trading Sessions). In support of this NYSE Arca Equities Rule 9.2(a), which price and trading volume information proposal, the Exchange has made imposes a duty of due diligence on its for the Shares will be published daily in representations, including: ETP Holders to learn the essential facts the financial sections of newspapers. (1) The Shares will conform to the relating to every customer prior to The Commission further believes that initial and continued listing criteria trading the Shares; (c) the risks involved the proposal to list and trade the Shares under NYSE Arca Equities Rule 8.600. in trading the Shares during the is reasonably designed to promote fair (2) The Exchange intends to utilize its Opening and Late Trading Sessions disclosure of information that may be existing surveillance procedures when an updated PIV will not be necessary to price the Shares applicable to derivative products (which calculated or publicly disseminated; (d) appropriately and to prevent trading include Managed Fund Shares) to how information regarding the PIV is when a reasonable degree of monitor trading in the Shares. The disseminated; (e) the requirement that transparency cannot be assured. The Exchange’s surveillance procedures are ETP Holders deliver a prospectus to Commission notes that the Exchange adequate to properly monitor Exchange will obtain a representation from the trading of the Shares in all trading 17 The Exchange represents that not all issuer of the Shares that the NAV per components of the Disclosed Portfolio for the Fund sessions and to deter and detect may trade on markets that are members of ISG, and Share will be calculated daily and that violations of Exchange rules and the Exchange may not have in place comprehensive the NAV and the Disclosed Portfolio applicable federal securities laws. The surveillance sharing agreements with such markets. will be made available to all market Exchange’s current trading surveillance The Commission notes that the Fund will be participants at the same time. investing primarily in securities of foreign large focuses on detecting securities trading capitalization companies with market Additionally, if it becomes aware that outside their normal patterns. When capitalizations of more than $1 billion and that are the NAV or the Disclosed Portfolio is subject to last-sale reporting. In addition, the Commission notes that though, an Authorized not disseminated daily to all market Fund; or (2) whether other unusual conditions or Participant may transact in cash, in whole or in circumstances detrimental to the maintenance of a participants at the same time, the part, with the Fund in connection with creations or fair and orderly market are present. Exchange will halt trading in the Shares redemptions, the cash amount delivered or received 15 until such information is available to all See supra note 6 and accompanying text. may not exceed 10% of the value of the in-kind Commentary .07 to NYSE Arca Equities Rule 8.600 creation or redemption basket, subject to certain market participants. Further, if the PIV requires that, if an investment adviser to the is not being disseminated as required, limited conditions. investment company issuing Managed Fund Shares The Commission further notes that the Fund, as the Exchange may halt trading during is affiliated with a broker-dealer, such investment an investment company registered under the 1940 the day in which the disruption occurs; adviser erect a ‘‘fire wall’’ between the investment Act, is subject to the diversification standards adviser and the broker-dealer with respect to access if the interruption persists past the day included in Section 5(b)(1) of the 1940 Act. The to information concerning the composition and/or Exchange represents that the Fund’s fundamental in which it occurred, the Exchange will changes to the investment company portfolio. policies, which may be changed only by a vote of halt trading no later than the beginning Commentary .07 also requires personnel, who make the holders of a majority of the Fund’s outstanding of the trading day following the decisions on the investment company’s portfolio voting securities, are as follows: (1) Regarding composition, must be subject to procedures interruption.14 The Exchange states that diversification, the Fund may not invest more than designed to prevent the use and dissemination of 5% of its total assets (taken at market value) in material nonpublic information regarding the open- securities of any one issuer, other than obligations applicable), name of security or financial end fund’s portfolio. See Commentary .07 to NYSE issued by the U.S. Government, its agencies and instrument, number of shares or dollar value of Arca Equities Rule 8.600. The Exchange represents instrumentalities, or purchase more than 10% of the financial instruments held in the portfolio, and that Grail Advisors, LLC is affiliated with a broker- voting securities of any one issuer, with respect to percentage weighting of the security or financial dealer, Grail Securities, LLC, and has implemented 75% of the Fund’s total assets; and (2) regarding instrument in the portfolio. a fire wall with respect to such broker-dealer concentration, the Fund may not invest more than 14 See NYSE Arca Equities Rule 8.600(d)(2)(D). regarding access to information concerning the 25% of its total assets in the securities of companies The Exchange states that trading in the Shares may composition and/or changes to the portfolio. The primarily engaged in any one industry or group of also be halted because of market conditions or for Exchange further represents that Grail Advisors, industries provided that (a) this limitation does not reasons that, in the view of the Exchange, make LLC, as the investment adviser of the Fund, and apply to obligations issued or guaranteed by the trading in the Shares inadvisable. These may each of the sub-advisers of the Fund, and their U.S. Government, its agencies and include: (1) The extent to which trading is not respective personnel, are subject to Investment instrumentalities, and (b) municipalities and their occurring in the securities comprising the Disclosed Advisers Act Rule 204A–1. agencies and authorities are not deemed to be Portfolio and/or the financial instruments of the 16 See NYSE Arca Equities Rule 8.600(d)(2)(B)(ii). industries.
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investors purchasing newly issued comments on the proposed rule change $5.00 generally, (2) not less than $2.50 Shares prior to or concurrently with the from interested persons. for index classes specifically listed in confirmation of a transaction; and (f) Rule 24.9.01(a), and (3) not less than $1 I. Self-Regulatory Organization’s trading information. for certain other index classes set forth Statement of the Terms of Substance of (4) The Fund will be in compliance in Rule 24.9.01 (e.g., 24.9.01(b) provides the Proposed Rule Change with Rule 10A–3 under the Act.18 This for $0.50 strike price intervals for approval order is based on the CBOE proposes to amend certain of its options based on one-one hundredth the Exchange’s representations. rules to allow the Exchange to list value of the DJIA, 24.9.01(h) provides For the foregoing reasons, the options on the Mini-Russell 2000 Index for $1 strike price intervals for Mini- Commission finds that the proposed (‘‘RMN’’ or ‘‘Mini-RUT’’), which is Nasdaq 100 Index (‘‘MNX’’ or ‘‘Mini- rule change is consistent with Section based on 1/10th the value of the Russell NDX’’) options). 6(b)(5) of the Act 19 and the rules and 2000 Index, at $1 strike intervals. The The Exchange now proposes that the regulations thereunder applicable to a text of the rule proposal is available on minimum strike price interval for RMN national securities exchange. the Exchange’s Web site (http:// options will be $1 or greater, if the strike www.cboe.org/legal), at the Exchange’s price is less than $200. The Exchange III. Conclusion Office of the Secretary and at the believes that $1 strike price intervals in It is therefore ordered, pursuant to Commission. this option series will provide investors Section 19(b)(2) of the Act,20 that the II. Self-Regulatory Organization’s with greater flexibility by allowing them proposed rule change (SR–NYSEArca– Statement of the Purpose of, and to establish positions that are better 2009–83) be, and it hereby is, approved. Statutory Basis for, the Proposed Rule tailored to meet their investment Change objectives. For the Commission, by the Division of For initial series, the Exchange would Trading and Markets, pursuant to delegated In its filing with the Commission, the authority.21 list at least two strike prices above and self-regulatory organization included two strike prices below the current Florence E. Harmon, statements concerning the purpose of, value of the RMN at or about the time Deputy Secretary. and basis for, the proposed rule change a series is opened for trading on the [FR Doc. E9–27604 Filed 11–17–09; 8:45 am] and discussed any comments it received Exchange. As part of this initial listing, BILLING CODE 8011–01–P on the proposed rule change. The text the Exchange would list strike prices of those statements may be examined at that are within 5 points from the closing the places specified in Item IV below. value of the RMN on the preceding day. SECURITIES AND EXCHANGE The Exchange has prepared summaries, As for additional series, the Exchange COMMISSION set forth in sections A, B, and C below, would be permitted to add additional [Release No. 34–60977; File No. SR–CBOE– of the most significant parts of such series when the Exchange deems it 2009–086] statements. necessary to maintain an orderly market, to meet customer demand or A. Self-Regulatory Organization’s Self-Regulatory Organizations; when the underlying RMN moves Statement of the Purpose of, and Chicago Board Options Exchange, substantially from the initial exercise Statutory Basis for, the Proposed Rule Incorporated; Notice of Filing and price or prices. To the extent that any Change Immediate Effectiveness of Proposal additional strike prices are listed by the To Permit $1 Strikes for RMN Options 1. Purpose Exchange, such additional strike prices This proposed rule change is based on shall be within thirty percent (30%) November 10, 2009. above or below the closing value of the Pursuant to Section 19(b)(1)1 of the a filing previously submitted by NASDAQ OMX PHLX, Inc. (‘‘Phlx’’) that RMN. The Exchange would also be Securities Exchange Act of 1934 (the permitted to open additional strike ‘‘Act’’) 2 and Rule 19b–4 thereunder,3 was recently approved by the Commission.6 prices that are more than 30% above or notice is hereby given that, on below the current RMN value provided November 6, 2009, the Chicago Board The purpose of the proposed rule change is to amend Rule 24.9, Terms of that demonstrated customer interest Options Exchange, Incorporated exists for such series, as expressed by (‘‘Exchange’’ or ‘‘CBOE’’) filed with the Index Option Contracts, by adding a new interpretation that would allow the institutional, corporate or individual Securities and Exchange Commission customers or their brokers. Market- (‘‘SEC’’ or ‘‘Commission’’) the proposed Exchange to list options on the RMN, which is based on 1/10th the value of Makers trading for their own account rule change as described in Items I and would not be considered when II below, which Items have been the Russell 2000 Index, at $1 or greater strike price intervals, if the strike price determining customer interest. In prepared by the Exchange. The 7 addition to the initial listed series, the Exchange filed the proposal as a ‘‘non- is less than $200. Strike price intervals for index Exchange may list up to sixty (60) controversial’’ proposed rule change options are set forth in Rules 5.5 and additional series per expiration month pursuant to Section 19(b)(3)(A)(iii) of 24.9 at three levels: (1) Not less than for each series in Mini-RUT options. the Act 4 and Rule 19b–4(f)(6) However, $1 strike price intervals may thereunder.5 The Commission is 6 See Exchange Act Release No. 60840 (October be listed on Mini-RUT options only publishing this notice to solicit 20, 2009), 74 FR 55593 (October 28, 2009) (SR– where the strike price is below $200. In Phlx–2009–77) (order approving proposal to permit addition, the Exchange proposes that it 18 See supra note 7. the listing of certain option series at $1 and $2.50 shall not list LEAPS on Mini-RUT 19 strike price intervals for strike prices below $200). 15 U.S.C. 78f(b)(5). options at intervals less than $2.50. 20 15 U.S.C. 78s(b)(2). CBOE’s current filing is solely concerned with $1 strike intervals for Mini-RUT options, which was The Exchange is also proposing to set 21 17 CFR 200.30–3(a)(12). the only multiply-listed option class addressed in 1 forth a delisting policy with respect to 15 U.S.C.78s(b)(1). SR–Phlx–2009–77. 2 Mini-RUT options. Specifically, the 15 U.S.C. 78a. 7 Currently, under Interpretation and Policy 3 17 CFR 240.19b–4. .01(a)(xlix) to Rule 24.9, the Exchange has authority Exchange would, on a monthly basis, 4 15 U.S.C. 78s(b)(3)(A)(iii). to list Mini-RUT options at $2.50 strike price review series that are outside a range of 5 17 CFR 240.19b–4(f)(6). intervals, if the strike price is less than $200. five (5) strikes above and five (5) strikes
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below the current value of the RMN and 24.9 as new Interpretations and Policy as the Commission may designate, if delist series with no open interest in .01(j). The Exchange is proposing to consistent with the protection of both the put and the call series having make this change because the investors and the public interest, it has a: (i) Strike higher than the highest previously referenced pending filings become effective pursuant to Section strike price with open interest in the put also overlap with the existing and 19(b)(3)(A) of the Act 13 and Rule 19b– and/or call series for a given expiration proposed lettering to Rule 24.9.01. 4(f)(6) thereunder.14 month; and (ii) strike lower than the Finally, the Exchange is proposing to The Exchange has requested that the lowest strike price with open interest in reduce the minimum strike price Commission waive the 30-day operative the put and/or call series for a given intervals for LEAPS on Mini-NDX delay and designate the proposed rule expiration month. options from $5 to $2.50 in order to change immediately operative, so that Notwithstanding the proposed conform CBOE’s listing ability with the Exchange may, for competitive delisting policy, customer requests to Phlx’s.9 reasons, list Mini-RUT options at the add strikes and/or maintain strikes in same $1 strike price intervals currently Mini-RUT options in series eligible for 2. Statutory Basis listed by Phlx. The Commission believes delisting shall be granted. The Exchange believes the proposed such waiver is consistent with the Further, in connection with the rule change is consistent with the protection of investors and the public proposed delisting policy, if the Securities Exchange Act of 1934 (the interest.15 Accordingly, the Commission Exchange identifies series for delisting, ‘‘Act’’)10 and the rules and regulations designates the proposed rule change the Exchange shall notify other options thereunder and, in particular, the operative upon filing with the exchanges with similar delisting requirements of Section 6(b) of the Commission. policies regarding eligible series for Act.11 Specifically, the Exchange At any time within 60 days of the listing, and shall work with such other believes the proposed rule change is filing of the proposed rule change, the exchanges to develop a uniform list of consistent with the Section 6(b)(5)12 Commission may summarily abrogate series to be delisted, so as to ensure requirements that the rules of an such rule change if it appears to the uniform series delisting of multiply exchange be designed to promote just Commission that such action is listed Mini-RUT options. and equitable principles of trade, to necessary or appropriate in the public It is expected that the proposed prevent fraudulent and manipulative interest, for the protection of investors, delisting policy for Mini-RUT options acts, to remove impediments to and to or otherwise in furtherance of the will be adopted by other options perfect the mechanism for a free and purposes of the Act. exchanges that list and trade Mini-RUT open market and a national market IV. Solicitation of Comments options. system, and, in general, to protect The Exchange also proposes to add investors and the public interest by Interested persons are invited to new Interpretation and Policy .16 to allowing the Exchange to list Mini-RUT submit written data, views, and Rule 5.5, Series of Option Contracts options at $1 strike price intervals. arguments concerning the foregoing, Open for Trading, which would be an including whether the proposed rule internal cross reference stating that the B. Self-Regulatory Organization’s change is consistent with the Act. intervals between strike prices for Mini- Statement on Burden on Competition Comments may be submitted by any of RUT option series would be determined The Exchange does not believe that the following methods: in accordance with proposed new the proposed rule change will impose Electronic Comments Interpretation and Policy .01(k) to Rule any burden on competition that is not • 24.9. necessary or appropriate in furtherance Use the Commission’s Internet of the purposes of the Act. comment form (http://www.sec.gov/ Technical Changes rules/sro.shtml); or The Exchange is proposing to make C. Self-Regulatory Organization’s • Send an e-mail to rule- some lettering and numbering changes Statement on Comments on the [email protected]. Please include File to the Interpretations and Policies to Proposed Rule Change Received From Number SR–CBOE–2009–086 on the Rules 5.5 and 24.9, which are being Members, Participants, or Others subject line. amended substantively by this filing. No written comments were solicited Paper Comments Specifically, the Exchange is proposing or received with respect to the proposed • Send paper comments in triplicate to re-number existing Interpretation and rule change. Policy .13 to Rule 5.5 as new to Elizabeth M. Murphy, Secretary, Interpretation and Policy .15. The III. Date of Effectiveness of the Securities and Exchange Commission, Exchange is proposing to make this Proposed Rule Change and Timing for 100 F Street, NE., Washington, DC change because the Exchange has two Commission Action 20549–1090. pending filings that have been formally Because the foregoing proposed rule All submissions should refer to File submitted which overlap with the change: (i) Does not significantly affect Number SR–CBOE–2009–086. This file existing and proposed numbering to the protection of investors or the public Rule 5.5.8 Similarly, the Exchange is interest; (ii) does not impose any 13 15 U.S.C. 78s(b)(3)(A). proposing to re-letter existing significant burden on competition; and 14 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– 4(f)(6)(iii) requires the self-regulatory organization Interpretation and Policy .01(h) to Rule (iii) by its terms, does not become to submit to the Commission written notice of its operative for 30 days from the date on intent to file the proposed rule change, along with 8 See SR–CBOE–2009–022 (proposal to list and which it was filed, or such shorter time a brief description and text of the proposed rule trade S&P 500 Dividend Index options and change, at least five business days prior to the date proposing to add new paragraph .13 to Rule 5.5 and of filing of the proposed rule change, or such 9 new paragraph (h) to Rule 24.9.01 for S&P 500 See Commentary .02(c) to Phlx Rule 1101A, shorter time as designated by the Commission. The Dividend Index options), and SR–CBOE–2009–080 Terms of Option Contracts, providing that LEAPS Exchange has satisfied this requirement. (proposal to list and trade options on Equity-Based on Mini-NDX options shall be listed at intervals not 15 For purposes only of waiving the 30-day Volatility Index options and proposing to add new less then $2.50. operative delay of this proposal, the Commission paragraph .14 to Rule 5.5 and new paragraph (i) to 10 15 U.S.C. 78s(b)(1). has considered the proposed rule’s impact on Rule 24.9.01 for Equity-Based Volatility Index 11 15 U.S.C. 78f(b). efficiency, competition, and capital formation. See options). 12 15 U.S.C. 78f(b)(5). 15 U.S.C. 78c(f).
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number should be included on the Securities Exchange Act of 1934 (‘‘PIMCO’’ or ‘‘Adviser’’) is the subject line if e-mail is used. To help the (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 a investment adviser to each Fund.6 State Commission process and review your proposed rule change to list and trade Street Bank & Trust Co. is the custodian comments more efficiently, please use shares (‘‘Shares’’) of the following funds and transfer agent for the Funds. The only one method. The Commission will of the PIMCO ETF Trust (‘‘Trust’’) under Trust’s Distributor is Allianz Global post all comments on the Commission’s NYSE Arca Equities Rule 8.600 Investors Distributors LLC Internet Web site (http://www.sec.gov/ (Managed Fund Shares): PIMCO (‘‘Distributor’’), an indirect subsidiary of rules/sro.shtml). Copies of the Enhanced Short Maturity Strategy Fund; Allianz Global Investors of America submission, all subsequent PIMCO Government Limited Maturity L.P., PIMCO’s parent company. The amendments, all written statements Strategy Fund; PIMCO Intermediate Distributor is a registered broker- with respect to the proposed rule Municipal Bond Strategy Fund; PIMCO dealer.7 change that are filed with the Prime Limited Maturity Strategy Fund; The Exchange states that the Shares Commission, and all written and PIMCO Short Term Municipal Bond will be subject to the initial and communications relating to the Strategy Fund (each a ‘‘Fund’’ and, continued listing criteria under NYSE proposed rule change between the collectively, the ‘‘Funds’’). The Arca Equities Rule 8.600 applicable to Commission and any person, other than proposed rule change was published in Managed Fund Shares 8 and that the those that may be withheld from the the Federal Register on September 11, Shares will comply with Rule 10A–3 public in accordance with the 2009.3 The Commission received no provisions of 5 U.S.C. 552, will be comments on the proposal. On 6 The Exchange represents that the Adviser, as the available for inspection and copying in November 10, 2009, the Exchange filed investment adviser of the Funds, and its related the Commission’s Public Reference Amendment No. 1 to the proposed rule personnel, are subject to Investment Advisers Act 4 Rule 204A–1. This Rule specifically requires the Room on official business days between change. This order provides notice of adoption of a code of ethics by an investment the hours of 10 a.m. and 3 p.m. Copies the filing of Amendment No. 1, and adviser to include, at a minimum: (i) Standards of of such filing also will be available for approves the proposed rule change, as business conduct that reflect the firm’s/personnel inspection and copying at the principal modified by Amendment No. 1 thereto, fiduciary obligations; (ii) provisions requiring supervised persons to comply with applicable office of the Exchange. All comments on an accelerated basis. federal securities laws; (iii) provisions that require received will be posted without change; I. Description of the Proposal all access persons to report, and the firm to review, the Commission does not edit personal their personal securities transactions and holdings identifying information from The Exchange proposes to list and periodically as specifically set forth in Rule 204A– trade the Shares pursuant to NYSE Arca 1; (iv) provisions requiring supervised persons to submissions. You should submit only report any violations of the code of ethics promptly information that you wish to make Equities Rule 8.600, which governs the to the chief compliance officer (‘‘CCO’’) or, available publicly. All submissions listing of Managed Fund Shares. Each of provided the CCO also receives reports of all should refer to File Number SR–CBOE– the Funds will be an actively managed violations, to other persons designated in the code 2009–086 and should be submitted on exchange-traded fund. The Shares will of ethics; and (v) provisions requiring the 5 investment adviser to provide each of the or before December 9, 2009. be offered by the Trust. Pacific supervised persons with a copy of the code of ethics For the Commission, by the Division of Investment Management Company LLC with an acknowledgement by said supervised Trading and Markets, pursuant to delegated persons. In addition, Rule 206(4)–7 under the 1 Advisers Act makes it unlawful for an investment authority.16 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b–4. adviser to provide investment advice to clients Florence E. Harmon, unless such investment adviser has (i) adopted and 3 See Securities Exchange Act Release No. 60619 implemented written policies and procedures Deputy Secretary. (September 3, 2009), 74 FR 46820 (‘‘Notice’’). reasonably designed to prevent violation, by the 4 [FR Doc. E9–27606 Filed 11–17–09; 8:45 am] Amendment No. 1 reflects the following changes investment adviser and its supervised persons, of to the proposed rule change: (a) On November 3, BILLING CODE 8011–01–P the Advisers Act and the Commission rules adopted 2009, the Trust filed a Registration Statement on thereunder; (ii) implemented, at a minimum, an Form N–1A with the Commission (File Nos. 333– annual review regarding the adequacy of the 155395 and 811–22250); (b) with respect to the policies and procedures established pursuant to SECURITIES AND EXCHANGE PIMCO Enhanced Short Maturity Strategy Fund, subparagraph (i) above and the effectiveness of their COMMISSION such Fund will be restricted from investing in implementation; and (iii) designated an individual derivative instruments such as options contracts, (who is a supervised person) responsible for [Release No. 34–60981; File No. SR– futures contracts, options on futures contracts, and administering the policies and procedures adopted NYSEArca–2009–79] swap agreements (including, but not limited to, under subparagraph (i) above. credit default swaps and swaps on exchange-traded 7 The Funds have made application for an order funds); and (c) the respective creation unit sizes for granting certain exemptive relief to the Trust under Self-Regulatory Organizations; NYSE the following Funds will be changed: Arca, Inc.; Notice of Filing of the 1940 Act. In compliance with Commentary .05 (i) PIMCO Enhanced Short Maturity Strategy to NYSE Arca Equities Rule 8.600, which applies Amendment No. 1 and Order Granting Fund creation unit size will be reduced to 70,000 to Managed Fund Shares based on an international Accelerated Approval of a Proposed shares from 100,000 shares; or global portfolio, the Trust’s application for Rule Change, as Modified by (ii) PIMCO Government Limited Maturity exemptive relief under the 1940 Act states that the Amendment No. 1 Thereto, Relating to Strategy Fund creation unit size will be reduced to Funds will comply with the federal securities laws 90,000 shares from 100,000 shares; and in accepting securities for deposits and satisfying Listing of Five Fixed Income Funds of (iii) PIMCO Prime Limited Maturity Strategy redemptions with redemption securities, including the PIMCO ETF Trust Fund creation unit size will be reduced to 90,000 that the securities accepted for deposits and the shares from 100,000 shares. securities used to satisfy redemption requests are November 10, 2009. The creation unit sizes for each of the PIMCO sold in transactions that would be exempt from On August 27, 2009, NYSE Arca, Inc. Intermediate Municipal Bond Strategy Fund and registration under the Securities Act of 1933 (15 (‘‘NYSE Arca’’ or ‘‘Exchange’’), through the PIMCO Short Term Municipal Bond Strategy U.S.C. 77a). Fund will not change and will be 100,000 shares, 8 The Exchange states that a minimum of 100,000 its wholly owned subsidiary, NYSE respectively. Shares will be outstanding at the commencement of Arca Equities, Inc. (‘‘NYSE Arca 5 The Trust is a Delaware statutory trust that is trading on the Exchange, and the Exchange will Equities’’), filed with the Securities and registered under the Investment Company Act of obtain a representation from the issuer of the Shares Exchange Commission (‘‘Commission’’), 1940 (15 U.S.C. 80a) (‘‘1940 Act’’). See Registration that the net asset value (‘‘NAV’’) per Share will be Statement on Form N–1A for the Trust filed with calculated daily and that the NAV and the pursuant to Section 19(b)(1) of the the Commission on November 3, 2009 (File Nos. Disclosed Portfolio will be made available to all 333–155395 and 811–22250) (‘‘Registration market participants at the same time. See Notice, 16 17 CFR 200.30–3(a)(12). Statement’’). supra note 3.
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under the Act,9 as provided by NYSE for inspection and copying at the session on the New York Stock Arca Equities Rule 5.3. Additional principal office of the Exchange. All Exchange (ordinarily 4 p.m. Eastern information regarding the Trust, each of comments received will be posted Time) on each business day. The Funds’ the Funds, the Shares, the Funds’ without change; the Commission does Web site will also include additional investment objectives, strategies, not edit personal identifying quantitative information updated on a policies, and restrictions, risks, fees and information from submissions. You daily basis relating to trading volume, expenses, creation and redemption should submit only information that prices, and NAV. Information regarding procedures, portfolio holdings and you wish to make available publicly. All the market price and volume of the policies, distributions and taxes, submissions should refer to File Shares will be continually available on availability of information, trading rules Number SR–NYSEArca–2009–79 and a real-time basis throughout the day via and halts, and surveillance procedures, should be submitted on or before electronic services, and the previous among other things, can be found in the December 9, 2009. day’s closing price and trading volume Registration Statement and in the information for the Shares will be 10 III. Discussion and Commission’s Notice, as applicable. Findings published daily in the financial sections II. Solicitation of Comments of newspapers. The Commission has carefully The Commission further believes that Interested persons are invited to reviewed the proposed rule change and the proposal is reasonably designed to submit written data, views, and finds that it is consistent with the promote fair disclosure of information requirements of Section 6 of the Act 11 arguments concerning whether that may be necessary to price the and the rules and regulations Amendment No. 1 to the proposed rule Shares appropriately and to prevent thereunder applicable to a national change is consistent with the Act. trading when a reasonable degree of securities exchange.12 In particular, the Comments may be submitted by any of transparency cannot be assured. The Commission finds that the proposal is the following methods: Commission notes that the Exchange consistent with Section 6(b)(5) of the will obtain a representation from the Electronic Comments Act,13 which requires, among other issuer that the NAV per Share will be • Use the Commission’s Internet things, that the Exchange’s rules be calculated daily and that the NAV and comment form (http://www.sec.gov/ designed to promote just and equitable the Disclosed Portfolio will be made rules/sro.shtml); or principles of trade, to remove • Send an e-mail to rule- available to all market participants at impediments to and perfect the 15 [email protected]. Please include File mechanism of a free and open market the same time. Additionally, if it Number SR–NYSEArca–2009–79 on the and a national market system, and, in becomes aware that the NAV or the subject line. general, to protect investors and the Disclosed Portfolio is not disseminated daily to all market participants at the Paper Comments public interest. The Commission notes that the Shares must comply with the same time, the Exchange will halt • Send paper comments in triplicate requirements of NYSE Arca Equities trading in the Shares until such to Elizabeth M. Murphy, Secretary, Rule 8.600 to be listed and traded on the information is available to all market 16 Securities and Exchange Commission, Exchange. participants. Further, if the PIV is not 100 F Street, NE., Washington, DC The Commission finds that the being disseminated as required, the 20549–1090. proposal to list and trade the Shares on Exchange may halt trading during the All submissions should refer to File the Exchange is consistent with Section day in which the disruption occurs; if Number SR–NYSEArca–2009–79. This 11A(a)(1)(C)(iii) of the Act,14 which sets the interruption persists past the day in file number should be included on the forth Congress’ finding that it is in the which it occurred, the Exchange will subject line if e-mail is used. To help the public interest and appropriate for the halt trading no later than the beginning Commission process and review your protection of investors and the of the trading day following the comments more efficiently, please use maintenance of fair and orderly markets interruption.17 The Exchange represents only one method. The Commission will to assure the availability to brokers, that the Adviser is affiliated with a post all comments on the Commission’s dealers, and investors of information broker-dealer, Allianz Global Investors Internet Web site (http://www.sec.gov/ with respect to quotations for and Distributors LLC, and has implemented rules/sro.shtml). Copies of the transactions in securities. Quotation and a ‘‘fire wall’’ between it and its broker- submission, all subsequent last-sale information for the Shares will dealer affiliate with respect to access to amendments, all written statements be available via the Consolidated Tape information concerning the composition with respect to the proposed rule Association (‘‘CTA’’) high-speed line, and/or changes to each of the Funds’ change that are filed with the and the Exchange will disseminate the portfolios. Further, the Commission Commission, and all written Portfolio Indicative Value (‘‘PIV’’) at notes that the Reporting Authority that communications relating to the least every 15 seconds during the Core provides the Disclosed Portfolio must proposed rule change between the Trading Session through the facilities of implement and maintain, or be subject Commission and any person, other than the CTA. In addition, the Funds will to, procedures designed to prevent the those that may be withheld from the make available on a Web site on each use and dissemination of material non- public in accordance with the business day the Disclosed Portfolio that provisions of 5 U.S.C. 552, will be will form the basis for the calculation of 15 See NYSE Arca Equities Rule 8.600(d)(1)(B). available for inspection and copying in the NAV, which will be determined as 16 See NYSE Arca Equities Rule 8.600(d)(2)(D). the Commission’s Public Reference of the close of the regular trading 17 Id. Trading in the Shares may also be halted because of market conditions or for reasons that, in Room, 100 F Street, NE., Washington, the view of the Exchange, make trading in the 11 DC 20549, on official business days 15 U.S.C. 78f. Shares inadvisable. These may include: (1) The between the hours of 10 a.m. and 3 p.m. 12 In approving this proposed rule change the extent to which trading is not occurring in the Commission has considered the proposed rule’s Copies of the filing also will be available securities comprising the Disclosed Portfolio and/ impact on efficiency, competition, and capital or the financial instruments of the Funds; or (2) formation. See 15 U.S.C. 78c(f). whether other unusual conditions or circumstances 9 17 CFR 240.10A–3. 13 17 U.S.C. 78f(b)(5). detrimental to the maintenance of a fair and orderly 10 See supra notes 3 and 5. 14 15 U.S.C. 78k–1(a)(1)(C)(iii). market are present.
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public information regarding the actual on a portfolio of securities, the SECURITIES AND EXCHANGE components of each of the portfolios.18 characteristics of which are similar to COMMISSION The Exchange has represented that those to be invested by the Funds.20 The the Shares are equity securities subject [Release No. 34–60983; File No. SR–NYSE– Commission also notes that it has 2009–84] to the Exchange’s rules governing the received no comments regarding the trading of equity securities. In support proposed rule change. Further, the Self-Regulatory Organizations; New of this proposal, the Exchange has made Commission believes that the additional York Stock Exchange LLC; Order representations, including: investment restrictions with respect to Approving a Proposed Rule Change, (1) The Shares will conform to the as Modified by Amendment No. 1, initial and continued listing criteria the PIMCO Enhanced Short Maturity Strategy Fund and the decreased Amending NYSE Rule 36 To Permit the under NYSE Arca Equities Rule 8.600. Use of Personal Portable or Wireless (2) The Exchange’s surveillance creation and redemption unit sizes for Communication Devices Off the procedures are adequate to properly certain of the Funds, as described in Exchange Trading Floor and Outside monitor Exchange trading of the Shares Amendment No. 1 to the proposed rule Other Restricted Access Areas in all trading sessions and to deter and change,21 do not raise any novel detect violations of Exchange rules and regulatory concerns. The Commission November 10, 2009. applicable federal securities laws. believes that accelerating approval of (3) Prior to the commencement of this proposal should benefit investors I. Introduction trading, the Exchange will inform its by creating, without undue delay, On August 27, 2009, the New York ETP Holders in an Information Bulletin additional competition in the market for Stock Exchange LLC (‘‘NYSE’’ or of the special characteristics and risks Managed Fund Shares. ‘‘Exchange’’) filed with the Securities associated with trading the Shares. and Exchange Commission Specifically, the Information Bulletin V. Conclusion (‘‘Commission’’), pursuant to Section will discuss the following: (a) The 1 It is therfore ordered, pursuant to 19(b)(1) of the Securities Exchange Act procedures for purchases and 2 Section 19(b)(2) of the Act,22 that the of 1934 (the ‘‘Act’’) and Rule 19b–4 redemptions of Shares and that Shares thereunder,3 a proposed rule change, as proposed rule change (SR–NYSEArca– are not individually redeemable; (b) modified by Amendment No. 1,4 to 2009–79), as modified by Amendment NYSE Arca Equities Rule 9.2(a), which amend NYSE Rule 36 to permit the use imposes a duty of due diligence on its No. 1 thereto, be, and it hereby is, of personal portable or wireless ETP Holders to learn the essential facts approved on an accelerated basis. communication devices off the relating to every customer prior to For the Commission, by the Division of Exchange Trading Floor and outside trading the Shares; (c) the risks involved Trading and Markets, pursuant to delegated other restricted access areas, and make in trading the Shares during the authority.23 corresponding technical changes. The Opening and Late Trading Sessions Florence E. Harmon, proposed rule change was published for when an updated PIV will not be Deputy Secretary. comment in the Federal Register on calculated or publicly disseminated; (d) 5 [FR Doc. E9–27607 Filed 11–17–09; 8:45 am] September 28, 2009. The Commission how information regarding the PIV is received no comments regarding the disseminated; (e) the requirement that BILLING CODE 8011–01–P proposal. This order approves the ETP Holders deliver a prospectus to proposed rule change. investors purchasing newly issued Shares prior to or concurrently with the II. Background confirmation of a transaction; and (f) Currently, NYSE Rule 36 trading information. (Communications Between Exchange (4) The Funds will be in compliance and Members’ Offices) prohibits with Rule 10A–3 under the Act. members and member organizations (5) The Funds will not invest in non- from establishing or maintaining any U.S. equity securities. telephonic or electronic This approval order is based on the communication, including the usage of Exchange’s representations. any portable or wireless communication For the foregoing reasons, the devices (i.e. cellular phone, wireless Commission finds that the proposed pager, BlackBerryTM, etc.), between the rule change is consistent with the Act Floor, as defined in NYSE Rule 6, and and the rules and regulations any other location without prior thereunder applicable to a national Exchange approval. securities exchange. Notwithstanding the rule’s general 20 prohibition on the use of portable or IV. Accelerated Approval See, e.g., Securities Exchange Act Release Nos. 57514 (March 17, 2008), 73 FR 15230 (March 21, wireless communication devices, The Commission finds good cause, 2008) (SR–Amex–2008–02) (approving the listing current Rule 36 permits Floor brokers to pursuant to Section 19(b)(2) of the and trading of shares of the Bear Stearns Current use Exchange authorized and issued Act,19 for approving the proposal prior Yield Fund); 57626 (April 4, 2008), 73 FR 19923 portable phones on the Floor to to the thirtieth day after the date of (April 11, 2008) (SR–NYSEArca–2008–28) (approving the trading of shares of the Bear Stearns 1 publication of the Notice in the Federal Current Yield Fund on the Exchange pursuant to 15 U.S.C.78s(b)(1). 2 Register. The Commission notes that it UTP); and 57801 (May 8, 2008), 73 FR 27878 (May 15 U.S.C. 78a. 3 has approved the listing and trading on 14, 2008) (SR–NYSEArca–2008–31) (approving the 17 CFR 240.19b–4. 4 the Exchange of shares of other actively listing and trading of shares of twelve actively- Amendment No. 1, which the Exchange filed on September 17, 2009, superseded and replaced the managed funds of the WisdomTree Trust). managed exchange-traded funds based original filing in its entirety. 21 See supra note 4. 5 See Securities Exchange Act Release No. 60691 18 See NYSE Arca Equities Rule 8.600(d)(2)(B)(ii). 22 15 U.S.C. 78s(b)(2). (September 18, 2009), 74 FR 49431 FR 34609 19 15 U.S.C. 78s(b)(2). 23 17 CFR 200.30–3(a)(12). (‘‘Notice’’).
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communicate with both member firms Recently, the Exchange adopted Rule ‘‘Floor’’ under Exchange rules, the and non-members off the Floor, subject 6A, setting forth a definition of Trading Exchange will retain jurisdiction over to certain restrictions.6 Floor brokers Floor that is distinct from the definition its members in these areas. As such, in may not, however, use Exchange of Floor. Specifically, the Trading Floor its filing, the Exchange noted that it authorized and issued devices on the is an area within the area of the ‘‘Floor’’ would retain jurisdiction over its NYSE Amex Options Trading Floor (as that is defined as ‘‘the restricted-access members and member firm employees defined in NYSE Rule 6A).7 In addition, physical areas designated by the to regulate conduct that is inconsistent current Rule 36 permits Designated Exchange for the trading of securities, with Exchange Rules and the federal Market Makers (‘‘DMMs’’), subject to commonly known as the ‘Main Room’ securities laws and rules thereunder restriction, to maintain at their posts and the ‘Garage.’ ’’ 11 As such, the (e.g., trading ahead, insider trading, telephone lines to the off-Floor offices of Trading Floor’s restricted access market manipulation).13 the DMM unit or the unit’s clearing physical area also includes the areas The proposal would thus permit firm.8 Such telephone lines may only be outside the Blue Line that include the members and member firm employees used to enter options or futures hedging member and member organization to use their personal communications orders through the DMM unit’s off-Floor booths and/or trading desks. devices in the hallways, stairwells, office or the unit’s clearing firm, or III. Description of the Proposal lobbies or members-only areas of the through a member (on the Floor) of an Exchange premises that are adjacent to options or futures exchange. These lines The Exchange proposes to amend the Trading Floors of the Exchange, may not, however, be used for the NYSE Rule 36 to permit the use of NYSE Amex Options and/or NYSE purpose of transmitting to the Floor personal portable or wireless Amex Equities.14 The Exchange stated orders for the purchase or sale of communication devices outside of the specifically that such usage would be securities. DMMs are also permitted to Exchange’s Trading Floor and other permitted in the lobby areas of the use at their posts wired or wireless restricted access areas, provided such Exchange’s facilities at 11 Wall Street, 6 devices, including computer terminals usage is consistent with all other and 18 New Street, and 2, 12, 18 and 20 or laptops, that are registered with the Exchange Rules and federal securities Broad Street, as well as in the corridor Exchange to communicate with their laws and rules thereunder. Floor brokers in front of the interior elevator bank system algorithms.9 Under current Rule would still be limited to using only inside of 18 Broad Street.15 36, the use of all other portable or Exchange authorized and issued In its filing, the Exchange stated that wireless communication devices on the portable phones on the Exchange the purpose of the proposal is to provide Floor is prohibited. Trading Floor and DMMs would still Exchange members and member firm As noted in the foregoing paragraph, only be permitted to use registered employees with a reasonable and the restrictions on the use of portable or telephone lines and/or wired or wireless comfortable space inside the physical wireless communication devices in devices at their posts, and all such confines of the Exchange’s buildings current Rule 36 relate to what is and is devices and communications would and facilities within which they may not permissible on the Exchange Floor. continue to be regulated by the use their personal portable or wireless Under NYSE Rule 6, the term Floor is Exchange. communication devices, without defined as ‘‘the trading Floor of the The proposal would permit Exchange diminishing the ability to monitor and Exchange and the premises immediately members and member firm employees regulate their conduct.16 According to adjacent thereto, such as the various to use personal portable or wireless the Exchange, the current prohibitions entrances and lobbies of the 11 Wall communications devices in designated of Rule 36 and the broad definition of Street, 18 New Street, 8 Broad Street, 12 areas of the Exchange’s buildings and ‘‘Floor’’ under Rule 6 together Broad Street and 18 Broad Street facilities that fall within the technical effectively require members and Buildings, and also means the telephone definition of the Floor under Rule 6, but member firm employees to exit the facilities available in these locations.’’ 10 that are outside the Trading Floor, and Exchange premises in order to use their other restricted access points (i.e. where personal portable or wireless there are turnstiles or card swipe pads 6 All members and member firm employees who communications devices.17 In the use an Exchange authorized and issued portable that electronically release locked doors Exchange’s view, the distance afforded 12 phone must execute a written acknowledgement as to permit authorized entry). Because by allowing a DMM, for example, to use to the usage of the phone and authorizing the the lobby and other corridor areas where a personal portable or wireless Exchange to receive data and records related to usage of personal portable or wireless incoming and outgoing calls. See NYSE Information communication device outside the Memos 08–40 (August 14, 2008) and 08–41 (August communications will now be permitted turnstiles is, in essence, equivalent to 14, 2008) (concerning the use of Exchange still fall within the broader definition of requiring a DMM to leave the authorized and issued portable phones on the Floor). See also NYSE/NYSE Amex Information 11 In its filing, the Exchange noted that the NYSE 13 Memo 08–66 (December 22, 2008). Amex Options Trading Floor is within the restricted See Notice, supra note 5. 7 See Rule 36, Supplementary Material .20—.23. access perimeter that encompasses the NYSE 14 See supra note 11. In addition, while the NYSE 8 The role of DMMs and their obligations on the Trading Floor and thus member and member firm Amex Options Rules permit NYSE Amex Options Exchange are described in Securities Exchange Act employees would not be permitted to use such members to use personal communications devices Release No. 58845 (October 24, 2008), 73 FR 64379 devices in that space under the terms of the on the NYSE Amex Options Trading Floor, those (October 29, 2008) (SR–NYSE–2008–46). Notably, proposed Rule defining where such devices are rules prohibit NYSE Amex Options members from pursuant to this Release, the Exchange phased out permissible. In addition, pursuant to the definitions using those devices on the Trading Floor of the the specialist system and adopted a Designated of ‘‘Floor’’ and ‘‘Trading Floor’’ in NYSE Rules 6 Exchange. See NYSE Amex Options Rule 902NY. Market Maker (‘‘DMM’’) structure. and 6A, and corresponding Rules 6 and 6A—NYSE 15 See Notice, supra note 5. 9 See NYSE Rule 36.30. Amex Equities, the NYSE and NYSE Amex Equities 16 See Notice, supra note 5. 10 The Exchange also has issued interpretive Trading Floors overlap and thus references to 17 See Notice, supra note 5. In the filing, the guidance that the ‘‘Floor’’ also includes the areas Exchange’s Trading Floor includes the NYSE Amex Exchange acknowledged that there are other areas outside the ‘‘Blue Line’’ (member and member Equities Trading Floor. See Securities Exchange Act on the Exchange’s premises where personal organization booths adjacent to the trading Floor) Release No. 59479 (March 2, 2009), 74 FR 10325 communications devices may be used by members and ‘‘any area reserved primarily for members, (March 10, 2009) (SR–NYSE–2009–23). and member firm employees (e.g., the cafeteria in including members’ lounges and bathrooms.’’ See 12 In the filing, the Exchange represented that the 11 Wall Street), but represented that these areas are NYSE/NYSE Amex Information Memo 08–66 majority of the doors that require card swipe for either too far from the Trading Floor to be practical (December 22, 2008). entry are opaque. See also note 19 infra. or do not have adequate reception for such devices.
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Exchange’s premises to do the same.18 open market and a national market Trading Floor information that may Further, the Exchange represented that system, and in general, to protect raise concerns.27 any time or place advantage to using investors and the public interest.23 The Commission notes that the such devices outside restricted access The Exchange has proposed that Exchange retains jurisdiction over its areas is significantly reduced by the fact members and member firm employees members for their conduct in the new that a DMM has no line of sight 19 and be permitted to use personal portable or areas where the use of personal no ability to hear trading activity on the wireless communication devices off the communication devices will now be Floor and the speed of electronic trading Exchange Trading Floor and outside of permitted because these areas are still would likely render stale any restricted access areas (i.e. restricted within the broader definition of Floor information a DMM had prior to leaving access areas are areas where there are under NYSE Rule 6.28 The Commission his or her post on the Trading Floor.20 turnstiles or card swipe pads that further notes the Exchange’s In addition, noting that the proposed electronically release locked doors to representation that it will issue a Notice rule amendments specifically provide permit authorized entry),24 subject to to Members reminding members of their that the use of personal portable or compliance with all other Exchange obligations under Securities Exchange wireless communication devices by Rules and the federal securities laws Act Release Nos. 33–7288 and 34– Exchange members and member firm and rules thereunder. The proposal 37182, concerning the ‘‘Use of employees is subject to compliance with marks a departure from the Exchange’s Electronic Media by Broker-Dealers, all other Exchange Rules and federal current prohibition on the use of such Transfer Agents, and Investment securities laws and rules thereunder, the devices in areas that are in close Advisers for Delivery of Information.’’ 29 Exchange represented that it will issue proximity to the Trading Floor of the In these releases, among other things, a Notice to Members that will, among Exchange, and its stated policy that the Commission noted that the other things, remind Exchange members ‘‘best practice’’ is for ‘‘personal contacts substantive and liability provisions of and member firm employees of their made using portable communication the federal securities laws, as well as the obligations under the requirements of devices, whether Exchange issued or recordkeeping requirements of the Act Securities Exchange Act Release Nos. not, [to] be made outside the apply equally to electronic and paper 33–7288 and 34–37182, concerning the building.’’ 25 based media.30 ‘‘Use of Electronic Media by Broker- The Commission finds, however, that Based on the foregoing, the Dealers, Transfer Agents, and the proposal strikes a reasonable Commission therefore finds the Investment Advisers for Delivery of balance between the Exchange’s interest proposal to be consistent with the Act. Information.’’ 21 in providing a convenient and The Commission believes that the The Exchange also proposed comfortable space for Exchange proposal to permit the use of personal corresponding technical amendments to members and member firm employees communication devices in certain Rule 36.20. to use their personal portable specified areas adjacent to the Trading Floor, while not without any risk, is IV. Discussion communications devices inside Exchange buildings and its interest in tempered by the speed of electronic After careful review, the Commission minimizing the risk of misuse of such trading, the existence of access barriers finds that the proposed rule change is devices, which are not subject to the between the Trading Floor and the areas consistent with the requirements of the same surveillance as Exchange where use of personal communication Act and the rules and regulations authorized and issued devices. In devices will now be permitted, and the thereunder applicable to a national particular, the Commission notes the fact that the Exchange retains securities exchange. Specifically, the Exchange’s representation that any time jurisdiction over its members while they Commission finds that the proposed or place advantage to using personal are in these areas. The Commission rule change is consistent with Section portable communication devices outside expects, however, that the Exchange 22 6(b)(5) of the Act, which requires, restricted points of access to the Trading will monitor compliance with the new among other things, that the rules of a Floor is ‘‘significantly reduced by the rule and inform the Commission if it national securities exchange be fact that a Floor Broker or DMM has no encounters difficulties in implementing designed to prevent fraudulent and line of sight and no ability to hear and enforcing it or otherwise finds that manipulative acts and practices, to trading activity on the [Trading] Floor the new rule raises regulatory concerns. promote just and equitable principles of and the speed of electronic trading IV. Conclusion trade, to remove impediments to, and would likely render stale any It is therefore ordered, pursuant to perfect the mechanism of, a free and information a DMM had prior to leaving Section 19(b)(2) of the Act,31 that the his or her post on the Trading Floor.’’ 26 18 See Notice, supra note 5. As noted above, the Commission 19 The Commission notes that in at least one 27 See supra note 19. lobby area there is a line of sight to the Trading expects that the Exchange will, in the 28 See note 13 and accompanying text supra. Floor and a trading post, unlike other lobby areas exercise of its regulatory 29 See Securities Act Release No 7288 and where the doors to the Trading Floor are opaque. responsibilities, work to ensure that any Securities Exchange Act Release No. 37182 (May 9, See supra note 12. The Commission acknowledges, line of sight to the Trading Floor that 1996), 61 FR 24643 (May 15, 1996) (S7–13–96). however, that it would be difficult to see any 30 may exist does not allow access to Id. See also FINRA Regulatory Notice 2007–59 specific information on the post screens from this (December 7, 2007), concerning the supervision of lobby area. The Commission expects the Exchange electronic communications, which among other to monitor this to ensure that this remains the case 23 In approving this proposed rule change, the things, reminds member firms of their obligation to and that such line of sight to the Trading Floor is Commission has considered the proposed rule’s (1) have supervisory policies and procedures to not misused. impact on efficiency, competition and capital monitor all electronic communications technology 20 See Notice, supra note 5. formation. See 15 U.S.C. 78c(f). used by the firm and its associated persons to 21 See Securities Exchange Act Release Nos. 33– 24 As noted above, restricted access areas include conduct the firm’s business; and (2) ensure that 7288 and 34–37182 (May 9, 1996), 61 FR 24643 the areas outside the Blue Line that include member their use of electronic communications media (May 15, 1996) (S7–13–96). See also FINRA and member organization booths and/or trading enables them to make and keep records, as required Regulatory Notice 2007–59 (December 7, 2007), desks. by Commission and Exchange rules (e.g., Rules concerning the supervision of electronic 25 See NYSE/NYSE Amex Information Memo 08– 17a–3 and 17a–4 under the Act and NYSE Rule communications. 66 (December 22, 2008). 440). 22 15 U.S.C. 78f(b)(5). 26 See Notice, supra note 5. 31 15 U.S.C. 78s(b)(2).
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proposed rule change (SR–NYSE–2009– the usage of any portable or wireless As noted in the foregoing paragraph, 84), as amended, be, and hereby is, communication devices (i.e. cellular the restrictions on the use of portable or approved. phone, wireless pager, BlackBerryTM, wireless communication devices in For the Commission, by the Division of etc.), between the Floor, as defined in current Rule 36—NYSE Amex Equities Trading and Markets, pursuant to delegated Rule 6—NYSE Amex Equities, and any relate to what is and is not permissible authority.32 other location without prior Exchange on the Exchange Floor. Under Rule 6— Florence E. Harmon, approval. NYSE Amex Equities, the term ‘‘Floor’’ Deputy Secretary. Notwithstanding the general is defined as having the same meaning [FR Doc. E9–27608 Filed 11–17–09; 8:45 am] prohibition on the use of portable or given that term ‘‘under the Act.’’ The BILLING CODE 8011–01–P wireless communication devices, Exchange has issued interpretive current Rule 36—NYSE Amex Equities guidance that the ‘‘Floor’’ includes the permits Floor brokers to use Exchange trading Floor of the Exchange and the SECURITIES AND EXCHANGE authorized and issued portable phones premises immediately adjacent thereto, COMMISSION on the Floor to communicate with both such as the various entrances and member firms and non-members off the lobbies of the 11 Wall Street, 18 New [Release No. 34–60984; File No. SR– Floor, subject to certain restrictions.6 Street, 8 Broad Street, 12 Broad Street NYSEAmex–2009–57] Floor brokers may not, however, use and 18 Broad Street Buildings, the Self-Regulatory Organizations; NYSE Exchange authorized and issued devices telephone facilities available in these Amex LLC; Order Approving a on the NYSE Amex Options Trading locations, the areas outside the ‘‘Blue Proposed Rule Change, as Modified by Floor (as defined in Rule 6A—NYSE Line’’ (member and member Amendment No. 1, Amending Rule Amex Equities).7 In addition, current organization booths adjacent to the 36—NYSE Amex Equities To Conform Rule 36—NYSE Amex Equities permits trading Floor), and any area reserved With Proposed Amendments to Designated Market Makers (‘‘DMMs’’), primarily for members, including Corresponding NYSE Rule 36 To subject to restriction, to maintain at members’ lounges and bathrooms.10 Permit the Use of Personal Portable or their posts telephone lines to the off- Recently, the Exchange adopted Rule Wireless Communication Devices Off Floor offices of the DMM unit or the 6A—NYSE Amex Equities, setting forth the Exchange Trading Floor and unit’s clearing firm.8 Such telephone a definition of ‘‘Trading Floor’’ that is Outside Other Restricted Access Areas lines may only be used to enter options distinct from the definition of Floor. or futures hedging orders through the Specifically, the Equities Trading Floor November 10, 2009. DMM unit’s off-Floor office or the unit’s is an area within the area of the ‘‘Floor’’ I. Introduction clearing firm, or through a member (on and defined as ‘‘the restricted-access the Floor) of an options or futures physical areas designated by the On August 27, 2009, NYSE Amex LLC exchange. These lines may not, Exchange for the trading of securities, (‘‘NYSE Amex’’ or ‘‘Exchange’’) filed however, be used for the purpose of commonly known as the ‘Main Room’ with the Securities and Exchange transmitting to the Floor orders for the and the ‘Garage.’’’ As such, the Trading Commission (‘‘Commission’’), pursuant 1 purchase or sale of securities. DMMs are Floor’s restricted access physical areas to Section 19(b)(1) of the Securities also permitted to use at their posts include the areas outside the Blue Line Exchange Act of 1934 (the ‘‘Act’’) 2 and 3 wired or wireless devices, including that include the member and member Rule 19b–4 thereunder, a proposed rule computer terminals or laptops, that are organization booths and/or trading change, as modified by Amendment No. 4 registered with the Exchange to desks. In accordance with Rule 6A— 1, to amend Rule 36—NYSE Amex communicate with their system NYSE Amex Equities, the Equities Equities to permit the use of personal algorithms.9 Under Rule 36—NYSE Trading Floor does not, however, portable or wireless communication Amex Equities, the use of all other include the areas where NYSE Amex- devices off the Exchange Trading Floor portable or wireless communication listed options are traded, commonly and outside other restricted access devices on the Floor is prohibited. known as the ‘‘Blue Room’’ and the areas, and to make corresponding ‘‘Extended Blue Room’’ (the ‘‘NYSE technical changes. The proposed rule 6 All members and member firm employees who Amex Options Trading Floor’’).11 change was published for comment in use an Exchange authorized and issued portable the Federal Register on September 28, phone must execute a written acknowledgement as 10 See NYSE/NYSE Amex Information Memo 08– 2009.5 The Commission received no to the usage of the phone and authorizing the 66 (December 22, 2008). comments regarding the proposal. This Exchange to receive data and records related to 11 In the filing, the Exchange noted that the NYSE incoming and outgoing calls. See NYSE Information Amex Options Trading Floor is within the restricted order approves the proposed rule Memos 08–40 (August 14, 2008) and 08–41 (August change. access perimeter that encompasses the NYSE and 14, 2008) (concerning the use of Exchange NYSE Amex Equities Trading Floors and thus authorized and issued portable phones on the Floor, II. Background member and member firm employees would not be incorporated by reference in joint NYSE/NYSE permitted to use such devices in that space under Currently, Rule 36—NYSE Amex Amex Information Memo 08–66 (December 22, the terms of the proposal. In addition, while the Equities prohibits members and member 2008)). Exchange’s Options Rules permit NYSE Amex 7 See Rule 36—NYSE Amex Equities, organizations from establishing or Options members to use personal communications Supplementary Material .20—.23 devices on the NYSE Amex Options Trading Floor, maintaining any telephonic or 8 The role of DMMs and their obligations on the those rules prohibit NYSE Amex Options members electronic communication, including Exchange adopted pursuant to the merger of the from using those devices on the Equities Trading Exchange with the New York Stock Exchange are Floor of the Exchange. See NYSE Amex Options described in Securities Exchange Act Release No. 32 17 CFR 200.30–3(a)(12). Rule 902NY. In addition, pursuant to the 58845 (October 24, 2008), 73 FR 64379 (October 29, definitions of ‘‘Floor’’ and ‘‘Trading Floor’’ in Rules 1 15 U.S.C.78s(b)(1). 2008) (SR–NYSE–2008–46). See also Securities 6 and 6A—NYSE Amex Equities, and 2 15 U.S.C. 78a. Exchange Act Release No. 59022 (November 26, corresponding NYSE Rules 6 and 6A, the NYSE 3 17 CFR 240.19b–4. 2008), 73 FR 73683 (December 3, 2008) (SR– Amex Equities and NYSE Trading Floors overlap 4 Amendment No. 1, which the Exchange filed on NYSEALTR–2008–10). Notably, pursuant to these and thus references to the NYSE Amex ‘‘Equities September 17, 2009, superseded and replaced the releases, the Exchange phased out the specialist Trading Floor’’ include the NYSE Trading Floor. original filing in its entirety. system and adopted a Designated Market Maker See Securities Exchange Act Release No. 59480 5 See Securities Exchange Act Release No. 60692 (‘‘DMM’’) structure. (March 2, 2009), 74 FR 10109 (March 9, 2009) (SR– (September 18, 2009), 74 FR 49428 (‘‘Notice’’). 9 See Rule 36.30—NYSE Amex Equities. Continued
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III. Description of the Proposal areas of the Exchange premises that are no ability to hear trading activity on the The Exchange proposes to amend adjacent to the Equities and Options Floor and the speed of electronic trading Rule 36—NYSE Amex Equities to Trading Floors of the Exchange and the would likely render stale any 15 conform with proposed amendments to NYSE. The Exchange stated information a DMM had prior to leaving 21 corresponding New York Stock specifically that such usage would be his or her post on the Trading Floor. Exchange (‘‘NYSE’’) Rule 36.12 The permitted in the lobby areas of the In addition, noting that the proposed proposed amendments to Rule 36— Exchange’s facilities at 11 Wall Street, 6 rule amendments specifically provide NYSE Amex Equities would permit the and 18 New Street, and 2, 12, 18 and 20 that the use of personal portable or wireless communication devices by use of personal portable or wireless Broad Street, as well as in the corridor Exchange members and member firm communication devices outside of the in front of the interior elevator bank 16 employees is subject to compliance with Exchange’s Trading Floor and other inside of 18 Broad Street. In its filing, the Exchange stated that all other Exchange Rules and/or federal restricted access areas, provided such the purpose of the proposal is to provide securities laws, the Exchange usage is consistent with all other Exchange members and member firm represented that it will issue a Notice to Exchange Rules and federal securities employees with a reasonable and Members that will, among other things, laws and rules thereunder. Floor brokers comfortable space inside the physical remind Exchange members and member would still be limited to using only confines of the Exchange’s buildings firm employees of their obligations Exchange authorized and issued and facilities within which they may under the requirements of Securities portable phones on the Exchange use their personal portable or wireless Exchange Act Release Nos. 33–7288 and Trading Floor and DMMs would still communication devices, without 34–37182, concerning the ‘‘Use of only be permitted to use registered diminishing the ability to monitor and Electronic Media by Broker-Dealers, telephone lines and/or wired or wireless regulate their conduct.17 According to Transfer Agents, and Investment devices at their posts, and all such the Exchange, the current prohibitions Advisers for Delivery of Information.’’ 22 devices and communications would of Rule 36—NYSE Amex Equities and The Exchange also proposed to continue to be regulated by the the broad definition of ‘‘Floor’’ under change Rule 36.23—NYSE Amex Exchange. Rule 6—NYSE Amex Equities together Equities to refer to NYSE Amex Options The proposal would permit members effectively require members and Rule 902NY to clarify that the and member firm employees to use member firm employees to exit the Exchange’s Options Rules permit NYSE personal portable or wireless Exchange premises in order to use their Amex Options members to use personal communications devices in designated personal portable or wireless communications devices on the NYSE areas of the Exchange’s buildings and communications devices.18 In the Amex Options Trading Floor, but that facilities that fall within the technical Exchange’s view, the distance afforded such rule prohibits NYSE Amex Options definition of the Floor under Rule 6, but by allowing a DMM, for example, to use members from using those devices on that are outside the Trading Floor, and a personal portable or wireless the Equities Trading Floor of the other restricted access points (i.e., communication device outside the Exchange. The Exchange also proposed where there are turnstiles or card swipe turnstiles is, in essence, equivalent to corresponding technical amendments to pads that electronically release locked requiring a DMM to leave the Rule 36.20—NYSE Amex Equities. 13 doors to permit authorized entry). 19 Exchange’s premises to do the same. IV. Discussion Because the lobby and other corridor Further, the Exchange represented that areas where usage of personal portable any time or place advantage to using After careful review, the Commission or wireless communications devices such devices outside restricted access finds that the proposed rule change is will now be permitted still fall within areas is significantly reduced by the fact consistent with the requirements of the the broader definition of ‘‘Floor’’ under that a DMM has no line of sight 20 and Act and the rules and regulations Exchange rules, the Exchange will retain thereunder applicable to a national jurisdiction over its members in these 15 It is important to note that the NYSE Amex securities exchange. Specifically, the areas. As such, in its filing, the Options Trading Floor is within the restricted Commission finds that the proposed Exchange noted that it would retain access perimeter that encompasses the NYSE and rule change is consistent with Section jurisdiction over its members and NYSE Amex Equities Trading Floors and thus 6(b)(5) of the Act,23 which requires, member and member firm employees would not be member firm employees to regulate permitted to use such devices in that space under among other things, that the rules of a conduct that is inconsistent with the terms of the proposed Rule defining where such national securities exchange be Exchange Rules and/or federal securities devices are permissible. See proposed Rule 36.23— designed to prevent fraudulent and laws (e.g., trading ahead, insider NYSE Amex Equities. In addition, while the manipulative acts and practices, to 14 Exchange’s Options Rules permit NYSE Amex trading, market manipulation). Options members to use personal communications promote just and equitable principles of The proposal would thus permit devices on the NYSE Amex Options Trading Floor, trade, to remove impediments to, and members and member firm employees those rules prohibit NYSE Amex Options members perfect the mechanism of, a free and to use their personal communications from using those devices on the Equities Trading Floor of the Exchange. See NYSE Amex Options where the doors to the Trading Floor are opaque. devices in the in the hallways, Rule 902NY. See supra note 13. The Commission acknowledges, stairwells, lobbies or members-only 16 See Notice, supra note 5. however, that it would be difficult to see any 17 See Notice, supra note 5. specific information on the post screens from this NYSEALTR–2009–21) (adopting Rule 6A—NYSE 18 See Notice, supra note 5. In the filing, the lobby area. The Commission expects the Exchange Amex Equities.) Exchange acknowledged that there are other areas to monitor this to ensure that this remains the case 12 See Securities Exchange Act Release No. 60691 on the Exchange’s premises where personal and that such line of sight to the Trading Floor is (September 18, 2009), 74 FR 49431 (September 28, communications devices may be used by members not misused. 2009) (SR–NYSE–2009–84). As more fully and member firm employees (e.g., the cafeteria in 21 See Notice, supra note 5. explained in the Notice, NYSE Amex Equities 11 Wall Street), but represented that these areas are 22 See Securities Exchange Act Release Nos. 33– Rules, are substantially identical to NYSE Rules 1– either too far from the Trading Floor to be practical 7288 and 34–37182 (May 9, 1996), 61 FR 24643 1004. or do not have adequate reception for such devices. (May 15, 1996) (S7–13–96). See also FINRA 13 In the filing, the Exchange represented that the 19 See Notice, supra note 5. Regulatory Notice 2007–59 (December 7, 2007), majority of the doors that require card swipe for 20 The Commission notes that in at least one concerning the supervision of electronic entry are opaque. See also note 20 infra. lobby area there is a line of sight to the Trading communications. 14 See Notice, supra note 5. Floor and a trading post, unlike other lobby areas 23 15 U.S.C. 78f(b)(5).
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open market and a national market Trading Floor information that may areas. The Commission expects, system, and in general, to protect raise concerns.28 however, that the Exchange will investors and the public interest.24 The Commission notes that the monitor compliance with the new rule The Exchange has proposed that Exchange retains jurisdiction over its and inform the Commission if it members and member firm employees members for their conduct in the new encounters difficulties in implementing be permitted to use personal portable or areas where the use of personal and enforcing it or otherwise finds that wireless communication devices off the communication devices will now be that the new rule raises regulatory Exchange Trading Floor and outside of permitted because these areas are still concerns. restricted access areas (i.e. restricted within the broader definition of Floor V. Conclusion access areas are areas where there are under Rule 6—NYSE Amex Equities.29 turnstiles or card swipe pads that The Commission further notes the It is therefore ordered, pursuant to electronically release locked doors to Exchange’s representation that it will Section 19(b)(2) of the Act,32 that the permit authorized entry),25 subject to issue a Notice to Members reminding proposed rule change (SR–NYSEAmex– compliance with all other Exchange members of their obligations under 2009–57), as amended, be, and hereby Rules and the federal securities laws Securities Exchange Act Release Nos. is, approved. and rules thereunder. The proposal 33–7288 and 34–37182, concerning the For the Commission, by the Division of marks a departure from the Exchange’s ‘‘Use of Electronic Media by Broker- Trading and Markets, pursuant to delegated current prohibition on the use of such Dealers, Transfer Agents, and authority.33 devices in areas that are in close Investment Advisers for Delivery of Florence E. Harmon, 30 proximity to the Trading Floor of the Information.’’ In these releases, Deputy Secretary. Exchange, and its stated policy that among other things, the Commission noted that the substantive and liability [FR Doc. E9–27609 Filed 11–17–09; 8:45 am] ‘‘best practice’’ is for ‘‘personal contacts BILLING CODE 8011–01–P made using portable communication provisions of the federal securities laws, devices, whether Exchange issued or as well as the recordkeeping not, [to] be made outside the requirements of the Act apply equally to 31 DEPARTMENT OF TRANSPORTATION building.’’ 26 electronic and paper based media. The Commission further finds that the The Commission finds, however, that Federal Aviation Administration the proposal strikes a reasonable added reference in Rule 36.23 to NYSE balance between the Exchange’s interest Amex Options Rule 902NY is consistent 19th Meeting: RTCA Special in providing a convenient and with the Act because it ensures that Committee 206/EUROCAE WG 76 comfortable space for Exchange Rule 36.23 references a rule that Plenary: AIS and MET Data Link clarifies members’ obligations. The members and member firm employees Services Commission also finds the proposed to use their personal portable technical changes to Rules 36.20 to be communications devices inside AGENCY: Federal Aviation consistent with the Act. Administration (FAA), DOT. Exchange buildings and its interest in Based on the foregoing, the minimizing the risk of misuse of such ACTION: Notice of RTCA Special Commission therefore finds the Committee 206/EUROCAE WG 76 devices, which are not subject to the proposal to be consistent with the Act. same surveillance as Exchange Plenary: AIS and MET Data Link The Commission believes that the Services meeting. authorized and issued devices. In proposal to permit the use of personal particular, the Commission notes the communication devices in certain SUMMARY: The FAA is issuing this notice Exchange’s representation that any time specified areas adjacent to the to advise the public of a meeting of or place advantage to using personal Exchange’s Equities Trading Floor, the RTCA Special Committee 206/ portable communication devices outside NYSE Amex Options Trading Floor, and EUROCAE WG 76 Plenary: AIS and restricted points of access to the Trading the NYSE Trading Floor, while not MET Data Link Services. Floor is ‘‘significantly reduced by the without any risk, is tempered by the DATES: The meeting will be held fact that a Floor Broker or DMM has no speed of electronic trading, the line of sight and no ability to hear December 7–11, 2009 from 9 a.m. to 5 existence of access barriers between p.m. trading activity on the [Trading] Floor such Trading Floors and the areas where ADDRESSES: The meeting will be held at and the speed of electronic trading use of personal communication devices Gilruth Center, Brazos Room, Space would likely render stale any will now be permitted, and the fact that Center Blvd, Gate 5, Building 207, information a DMM had prior to leaving the Exchange retains jurisdiction over 27 Houston, TX 77058, 281–483–0304; his or her post on the Trading Floor.’’ its members while they are in these As noted above, the Commission Contact Person: Tom Evans, (P) 757– 864–2499, (C) 757–268–4852, (E) expects that the Exchange will, in the 28 See supra note 20. exercise of its regulatory 29 See note 14 and accompanying text supra. [email protected]. responsibilities, work to ensure that any 30 See Securities Act Release No 7288 and FOR FURTHER INFORMATION CONTACT: line of sight to the Trading Floor that Securities Exchange Act Release No. 37182 (May 9, RTCA Secretariat, 1828 L Street, NW., may exist does not allow access to 1996), 61 FR 24643 (May 15, 1996) (S7–13–96). Suite 805, Washington, DC 20036; 31 Id. See also FINRA Regulatory Notice 2007–59 (December 7, 2007), concerning the supervision of telephone (202) 833–9339; fax (202) 24 In approving this proposed rule change, the electronic communications, which among other 833–9434; Web site http://www.rtca.org. Commission has considered the proposed rule’s things, reminds member firms of their obligation to SUPPLEMENTARY INFORMATION: Pursuant impact on efficiency, competition and capital (1) have supervisory policies and procedures to formation. See 15 U.S.C. 78c(f). monitor all electronic communications technology to section 10(a)(2) of the Federal 25 As noted above, restricted access areas include used by the firm and its associated persons to Advisory Committee Act (Pub. L. 92– the areas outside the Blue Line that include member conduct the firm’s business; and (2) ensure that 463, 5 U.S.C., Appendix 2), notice is and member organization booths and/or trading their use of electronic communications media hereby given for a RTCA Special desks. enables them to make and keep records, as required 26 See NYSE/NYSE Amex Information Memo 08– by Commission and Exchange rules (e.g., Rules 66 (December 22, 2008). 17a–3 and 17a–4 under the Act and Rule 440— 32 15 U.S.C. 78s(b)(2). 27 See Notice, supra note 5. NYSE Amex Equities). 33 17 CFR 200.30–3(a)(12).
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Committee 206/EUROCAE WG 76 DEPARTMENT OF TRANSPORTATION Business Park Drive, Building G, Plenary: AIS and MET Data Link Memphis, TN 38118. Documents Services meeting. The agenda will Federal Aviation Administration reflecting this FAA action can be include: reviewed in person at this same Noise Compatibility Program (NCP); 14 location. 7 December—Monday CFR Part 150; Notice of Record of Approval (ROA) the Louisville SUPPLEMENTARY INFORMATION: The FAA 9 a.m. Opening Plenary International Airport, Louisville, KY has reviewed Noise Abatement • Chairmen’s remarks and Host’s (SDF) Measures (NA–2), (NA–3) and (NA–7) in comments accordance with 14 CFR Part 150. The AGENCY: Federal Aviation ROA contains the FAA’s decisions for 3 • Introductions, review and approve Administration (FAA), DOT. of the 7 NCP measures that were meeting agenda and approval of ACTION: Notice. previously deferred under LRAA’s 2003 previous meeting minutes NCP. The FAA has given its disapproval SUMMARY: The Federal Aviation • Schedule for this week to the Runway 17R offset approach Administration (FAA) announces its • Action Item Review request at LRAA. All other portions of findings on the noise compatibility the previously issued ROA remain in • Schedule for next meetings program update submitted by the effect. 1 a.m. Presentations Louisville Regional Airport Authority The following is a brief overview of (LRAA). the request: • Proposal for a MASPS/MOPS for On October 29, 2008, the LRAA AIS/MET Data Link Services—Gary On October 29, 2008, the LRAA submitted to the FAA Air Traffic provided the FAA Air Traffic Livack & Mark Mutchler Organization (ATO) a request with Organization with a letter and • To be determined supporting documentation for an offset supporting documentation requesting an approach to Runway 17R at Louisville 1 p.m. SPR offset approach to Runway 17R at International Airport (SDF). This Louisville International Airport (SDF). 8 December—Tuesday request was for a re-evaluation of noise This was additional information abatement measure NA–7, and submitted for re-evaluation of 9 a.m. Joint AIS and MET Subgroup associated measures NA–2 and NA–3, Meetings previously submitted but deferred noise submitted to the FAA for action in its abatement measures NA–2, NA–3, and 9 December—Wednesday 2003 NCP but were deferred. NA–7 in LRAA’s 2003 NCP The FAA ATO evaluated the offset 9 a.m. Joint AIS and MET Subgroup approach procedure provided by LRAA. Issued in Memphis, TN on November 3, 2009. Meetings After considerable review and evaluation, the procedure was Tommy L Dupree, 10 December—Thursday disapproved. The FAA ATO notified Acting Manager, Memphis Airports District LRAA of its determination on April 3, Office, Southern Region. 9 a.m. Joint AIS and MET Subgroup 2009. Subsequent to ATO’s [FR Doc. E9–27684 Filed 11–17–09; 8:45 am] Meetings determination, the FAA issued its BILLING CODE P 11 December—Friday Record of Approval (ROA) concerning the LRAA’s NCP update on August 4, 9 a.m. Joint AIS and MET Subgroup 2009, and disapproved noise abatement DEPARTMENT OF TRANSPORTATION Meetings measures NA–2, NA–3, and NA–7. Surface Transportation Board 10:30 a.m. Plenary Session In its evaluation, the FAA reviewed • the proposal under 14 CFR part 150 and [STB Finance Docket No. 35311] Other Business the Aviation Safety and Noise • Meeting Plans and Dates Abatement Act of 1979. Section 150.35 BNSF Railway Company—Trackage Rights Exemption—Union Pacific Attendance is open to the interested of Part 150 includes language stating that programs will be approved under Railroad Company public but limited to space availability. this part if program measures relating to With the approval of the chairmen, the use of flight procedures for noise Pursuant to a written supplemental members of the public may present oral control can be implemented within the trackage rights agreement dated January statements at the meeting. Persons period covered by the program and 1, 2009, BNSF Railway Company wishing to present statements or obtain without reducing the level of aviation (BNSF) has agreed to amend the existing information should contact the person safety provided or adversely affecting overhead trackage rights previously listed in the FOR FURTHER INFORMATION the efficient use and management of the granted to Union Pacific Railroad CONTACT section. Members of the public Company (UP) over BNSF’s Bieber line navigable airspace and air traffic control 1 may present a written statement to the systems. at Keddie, CA. committee at any time. According to BNSF, the purpose of DATES: Effective Date: The effective date the proposed transaction is to amend Issued in Washington, DC, on November of the FAA’s disapproval of the request the parties’ existing agreement to 12, 2009. for an offset approach to Runway 17R at accurately reflect the trackage rights Francisco Estrada C., Louisville International Airport is April received by UP under that agreement. RTCA Advisory Committee. 3, 2009. The effective date of FAA’s ROA of LRAA’s NCP update is August [FR Doc. E9–27662 Filed 11–17–09; 8:45 am] 1 This decision embraces Finance Docket No. 4, 2009. 32760 (Sub-No. 1) in which the original trackage BILLING CODE 4910–13–P FOR FURTHER INFORMATION CONTACT: rights were granted to UP in connection with UP’s acquisition of control of Southern Pacific Stephen Wilson, Community Planner, Transportation Company and were exempted by the Federal Aviation Administration, Board. Union Pacific/Southern Pacific Merger, 1 Memphis Airports District Office, 2862 S.T.B. 233 (1996).
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Specifically, BNSF states that the DEPARTMENT OF THE TREASURY Department of the Treasury. amendment deletes the existing Dan Tangherlini, agreement’s Exhibit A and replaces it Notice of Request for Public Comment Assistant Secretary for Management and with a new Exhibit A (map). BNSF also on the Accessibility to Department of Chief Financial Officer. states that the amendment provides that the Treasury Conducted Programs and [FR Doc. E9–27622 Filed 11–17–09; 8:45 am] UP will perform signal maintenance on Activities by Individuals With BILLING CODE 4810–25–P all signal facilities between BNSF’s Disabilities Bieber line (milepost 202.72) and wye AGENCY: Departmental Offices, Treasury. connections with UP’s Canyon DEPARTMENT OF THE TREASURY Subdivision. ACTION: Notice of request for public The transaction is scheduled to be comment. Office of Thrift Supervision consummated on December 2, 2009, the SUMMARY: Section 504 of the effective date of the exemption (30 days Privacy of Consumer Financial Rehabilitation Act of 1973 requires that after the exemption was filed). Information As a condition to this exemption, any programs and activities conducted by federal agencies be accessible to AGENCY: Office of Thrift Supervision employees affected by the trackage (OTS), Treasury. rights will be protected by the individuals with disabilities. The conditions imposed in Norfolk and Department of the Treasury invites the ACTION: Notice and request for comment. Western Ry. Co.—Trackage Rights—BN, public to comment on any barriers to the accessibility of its conducted SUMMARY: The proposed information 354 I.C.C. 605 (1978), as modified in collection request (ICR) described below Mendocino Coast Ry., Inc.—Lease and programs and activities by individuals with disabilities. has been submitted to the Office of Operate, 360 I.C.C. 653 (1980). Management and Budget (OMB) for DATES: Comments should be received on Pursuant to the Consolidated review and approval, as required by the Appropriations Act, 2008, Public Law or before December 30, 2009 to be assured of consideration. Paperwork Reduction Act of 1995. OTS 110–161, section 193, 121 Stat. 1844 is soliciting public comments on the (2007), nothing in this decision ADDRESSES: Comments may be proposal. authorizes the following activities at any submitted via electronic mail at solid waste rail transfer facility: [email protected], or via DATES: Submit written comments on or collecting, storing, or transferring solid mail addressed to the Director, Office of before December 18, 2009. A copy of waste outside of its original shipping Civil Rights and Diversity, 1500 this ICR, with applicable supporting container; or separating or processing Pennsylvania Avenue, NW., documentation, can be obtained from solid waste (including baling, crushing, Washington, DC 20220. RegInfo.gov at: http://www.reginfo.gov/ compacting, and shredding). The term FOR FURTHER INFORMATION CONTACT: public/do/PRAMain. ‘‘solid waste’’ is defined in section 1004 Lydia E. Aponte at (202) 622–8335 (not ADDRESSES: Send comments, referring to of the Solid Waste Disposal Act, 42 a toll-free-call), or by e-mail to the above the collection by title of the proposal or U.S.C. 6903. address. by OMB approval number, to OMB and This notice is filed under 49 CFR SUPPLEMENTARY INFORMATION: Request OTS at these addresses: Office of 1180.2(d)(7). If the notice contains false for Comments: Comments are requested Information and Regulatory Affairs, or misleading information, the concerning: (1) Any existing barriers to Attention: Desk Officer for OTS, U.S. exemption is void ab initio. Petitions to the access by individuals with Office of Management and Budget, revoke the exemption under 49 U.S.C. disabilities, and how they impede 725—17th Street, NW., Room 10235, 10502(d) may be filed at any time. The access to the program or activity; (2) Washington, DC 20503, or by fax to filing of a petition to revoke will not Any existing resources that may be used (202) 395–6974; and Information automatically stay the effectiveness of to address these barriers, and how they Collection Comments, Chief Counsel’s the exemption. Stay petitions must be could be employed; (3) The best ways to Office, Office of Thrift Supervision, filed by November 25, 2009 (at least 7 improve accessibility to Department of 1700 G Street, NW., Washington, DC days before the exemption becomes the Treasury programs and activities by 20552, by fax to (202) 906–6518, or by effective). e-mail to An original and 10 copies of all individuals with disabilities. Members of the public providing comments are [email protected]. pleadings, referring to STB Finance OTS will post comments and the related Docket No. 35311, must be filed with urged to keep comments succinct and responsive to these subjects. index on the OTS Internet Site at the Surface Transportation Board, 395 E http://www.ots.treas.gov. In addition, Street, SW., Washington, DC 20423– The Department of the Treasury: The Department of the Treasury is an interested persons may inspect 0001. In addition, a copy of each comments at the Public Reading Room, pleading must be served on Adrian L. Executive Department composed of the following bureaus: Departmental 1700 G Street, NW., by appointment. To Steel, Jr., Mayer Brown LLP, 1999 K make an appointment, call (202) 906– Street, NW., Washington, DC 20006– Offices; Internal Revenue Service; Office of the Comptroller of the Currency; 5922, send an e-mail to 1101. [email protected], or send a Board decisions and notices are Office of Thrift Supervision; Bureau of Engraving and Printing; United States facsimile transmission to (202) 906– available on our Web site at http:// 7755. www.stb.dot.gov. Mint; Bureau of Public Debt; Financial Management Service; Alcohol and FOR FURTHER INFORMATION CONTACT: For Decided: November 13, 2009. Tobacco, Tax and Trade Bureau; further information or to obtain a copy By the Board, Rachel D. Campbell, Financial Crimes Enforcement Network; of the submission to OMB, please Director, Office of Proceedings. Office of Inspector General; Special contact Ira L. Mills at, Jeffrey Herzig, Inspector General for the Troubled [email protected] (202) 906–6531, Clearance Clerk. Assets Relief Program; and the Treasury or facsimile number (202) 906–6518, [FR Doc. E9–27698 Filed 11–17–09; 8:45 am] Inspector General for Tax Regulations and Legislation Division, BILLING CODE 4915–01–P Administration. Chief Counsel’s Office, Office of Thrift
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Supervision, 1700 G Street, NW., Dated: November 12, 2009. DEPARTMENT OF VETERANS Washington, DC 20552. Ira L. Mills, AFFAIRS SUPPLEMENTARY INFORMATION : OTS may Paperwork Clearance Officer, Office of Thrift [OMB Control No. 2900–0377] not conduct or sponsor an information Supervision. collection, and respondents are not [FR Doc. E9–27672 Filed 11–17–09; 8:45 am] Proposed Information Collection required to respond to an information BILLING CODE 6720–01–P (Claim for Repurchase of Loan) collection, unless the information Activity: Comment Request collection displays a currently valid AGENCY: Veterans Benefits OMB control number. As part of the DEPARTMENT OF THE TREASURY approval process, we invite comments Administration, Department of Veterans on the following information collection. Office of Thrift Supervision Affairs. Title of Proposal: Privacy of ACTION: Notice. Consumer Financial Information. [AC–30: OTS No. H–4648] OMB Number: 1550–0103. SUMMARY: The Veterans Benefits Administration (VBA), Department of Form Number: N/A. Northwest Bancshares, Inc., Warren, Regulation requirement: 12 CFR part Veterans Affairs (VA), is announcing an 573. PA; Approval of Conversion opportunity for public comment on the Description: These information Application proposed collection of certain collections are required under section information by the agency. Under the 504 of the Gramm-Leach-Bliley Act Notice is hereby given that on Paperwork Reduction Act (PRA) of (Act), Public Law 106–102. Section 502 November 9, 2009, the Office of Thrift 1995, Federal agencies are required to of the Act prohibits a financial Supervision approved the application of publish notice in the Federal Register institution from disclosing nonpublic Northwest Savings Bank, Warren, concerning each proposed collection of personal information about a consumer Pennsylvania, to convert to the stock information, including each proposed to nonaffiliated third parties unless the form of organization. Copies of the extension of a currently approved institution satisfies various disclosure application are available for inspection collection, and allow 60 days for public requirements (i.e., provides a privacy by appointment (phone number: 202– comment in response to the notice. This notice and opt out notice) and the 906–5922 or e-mail notice solicits comments on information consumer has not elected to opt out of [email protected]) at the needed to repurchase a default loan. the disclosure. Section 504 requires the Public Reading Room, 1700 G Street, DATES: Written comments and Office of Thrift Supervision, as well as NW., Washington, DC 20552, and the recommendations on the proposed the Office of the Comptroller of the OTS Northeast Regional Office, collection of information should be Currency, Board of Governors of the Harborside Financial Center Plaza Five, received on or before January 19, 2010. Federal Reserve System, Federal Deposit Suite 1600, Jersey City, New Jersey ADDRESSES: Submit written comments Insurance Corporation, National Credit 07311. on the collection of information through Union Administration, Federal Trade Dated: November 10, 2009. the Federal Docket Management System Commission, and Securities and (FDMS) at http://www.Regulations.gov Exchange Commission to issue By the Office of Thrift Supervision. or to Nancy J. Kessinger, Veterans regulations as necessary to implement Sandra E. Evans, Benefits Administration (20M35), the notice requirements and restrictions. Federal Register Liaison. Department of Veterans Affairs, 810 Consumers use the privacy notice [FR Doc. E9–27545 Filed 11–17–09; 8:45 am] Vermont Avenue, NW., Washington, DC information to determine whether they BILLING CODE M 20420 or e-mail to want personal information disclosed to [email protected]. Please refer to third parties that are not affiliated with ‘‘OMB Control No. 2900–0377’’ in any the institution. Further, consumers use DEPARTMENT OF THE TREASURY correspondence. During the comment the opt-out notice mechanism to advise period, comments may be viewed online the institution of their wishes regarding Office of Thrift Supervision at FDMS. disclosure of their personal information. FOR FURTHER INFORMATION CONTACT: Institutions use the opt-out information Home Federal Savings Bank, Detroit, Nancy J. Kessinger at (202) 461–9769 or to determine the wishes of their MI; Notice of Appointment of Receiver FAX (202) 275–5947. consumers and to act appropriately. Type of Review: Extension of a SUPPLEMENTARY INFORMATION: Under the Notice is hereby given that, pursuant PRA of 1995 (Pub. L. 104–13; 44 U.S.C. currently approved collection. to the authority contained in section Affected Public: Business or other for- 3501–3521), Federal agencies must 5(d)(2) of the Home Owners’ Loan Act, obtain approval from the Office of profit. the Office of Thrift Supervision (OTS) Estimated Number of Respondents: Management and Budget (OMB) for each has duly appointed the Federal Deposit 68,378. collection of information they conduct Estimated Burden Hours per Insurance Corporation as sole Receiver or sponsor. This request for comment is Response: 80 hours for de novos and for Home Federal Savings Bank, Detroit, being made pursuant to Section acquisitions: 8 hours for institutions; Michigan (OTS No. 05171), on 3506(c)(2)(A) of the PRA. and .5 hours for customers. November 6, 2009. With respect to the following Estimated Frequency of Response: On Dated: November 10, 2009. collection of information, VBA invites comments on: (1) Whether the proposed occasion. By the Office of Thrift Supervision. Estimated Total Burden: 44,543 collection of information is necessary hours. Sandra E. Evans, for the proper performance of VBA’s Clearance Officer: Ira L. Mills, (202) Federal Register Liaison. functions, including whether the 906–6531, Office of Thrift Supervision, [FR Doc. E9–27547 Filed 11–17–09; 8:45 am] information will have practical utility; 1700 G Street, NW., Washington, DC BILLING CODE M (2) the accuracy of VBA’s estimate of the 20552. burden of the proposed collection of
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information; (3) ways to enhance the Abstract: Holders of delinquent Estimated Average Burden per quality, utility, and clarity of the vendee accounts guaranteed by VA Respondent: 30 minutes. information to be collected; and (4) complete VA Form 26–8084 to request Frequency of Response: One-time. ways to minimize the burden of the a repurchase of a loan that has been in collection of information on default for three months and the amount Estimated Number of Respondents: respondents, including through the use of the delinquency equals or exceeds the 60. of automated collection techniques or sum of two monthly installments. VA Dated: November 13, 2009. the use of other forms of information notifies the obligor(s) in writing of the By direction of the Secretary. technology. loan repurchased, and that the vendee Title: Claim for Repurchase of Loan, account will be serviced and maintained Denise McLamb, VA Form 26–8084. by VA. Program Analyst, Enterprise Records Service. OMB Control Number: 2900–0377. Affected Public: Business or other for- [FR Doc. E9–27714 Filed 11–17–09; 8:45 am] Type of Review: Extension of a profit. BILLING CODE P currently approved collection. Estimated Annual Burden: 30 hours.
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Part II
Environmental Protection Agency 40 CFR Part 180 Carbofuran; Order Denying FMC’s Objections and Requests for Hearing; Final Rule
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ENVIRONMENTAL PROTECTION I. General Information CWA—Clean Water Act CWS—Community Water System AGENCY A. Does this Action Apply to Me? DEEM–FCID—Dietary Exposure 40 CFR Part 180 In this document EPA denies Evaluation Model-Food Commodity objections and hearing requests by the Intake Database [EPA–HQ–OPP–2005–0162; FRL–8797–6] National Corn Growers Association, ECG—Electrocardiogram National Sunflower Association, EDWC—Estimated Drinking Water Carbofuran; Order Denying FMC’s National Potato Council, and FMC Concentration Objections and Requests for Hearing Corporation (‘‘Petitioners’’) concerning EPA—Environmental Protection Agency EPA’s final rule revoking all pesticide FACA—Federal Advisory Committee AGENCY: Environmental Protection tolerances for carbofuran. This action Act Agency (EPA). may also be of interest to agricultural FDA—Food and Drug Administration ACTION: Order. producers, food manufacturers, or FIFRA—Federal Insecticide, Fungicide, pesticide manufacturers. Potentially and Rodenticide Act SUMMARY: In this order, EPA denies affected entities may include, but are FFDCA—Federal Food, Drug, and objections to, and requests for hearing not limited to: Cosmetic Act on, a final rule revoking all pesticide • Crop production (NAICS code 111). FQPA—Food Quality Protection Act of tolerances for carbofuran under section • Animal production (NAICS code 1996 408(d) of the Federal Food, Drug, and 112). HSRB—Human Studies Review Board Cosmetic Act (FFDCA). The objections • Food manufacturing (NAICS code HUC–8—8-digit hydrologic unit code and hearing requests were filed on June 311). IRED—Interim Reregistration Eligibility 30, 2009, by the National Corn Growers • Pesticide manufacturing (NAICS Decision Association, National Sunflower code 32532). LD —Lethal Dose for 50% of a Association, National Potato Council, 50 This listing is not intended to be population and FMC Corporation (‘‘Petitioners’’). exhaustive, but rather provides a guide LOAEL—Lowest Observable Adverse DATES: This final order is effective for readers regarding entities likely to be Effect Level November 18, 2009. affected by this action. Other types of NAWQA—National Water Quality ADDRESSES: EPA has established a entities not listed in this unit could also Assessment Program docket for this action under docket be affected. The North American NHEERL—National Health and identification (ID) number EPA–HQ– Industrial Classification System Environmental Effects Laboratory OPP–2005–0162. To access the (NAICS) codes have been provided to NMC CRA—N-Methyl Carbamate electronic docket, go to http:// assist you and others in determining Cumulative Risk Assessment www.regulations.gov, and search for the whether this action might apply to NOAEL—No Observable Adverse Effect docket number. Follow the instructions certain entities. If you have any Level on the regulations.gov Web site to view questions regarding the applicability of NOIC—Notice of Intent to Cancel the docket index or access available this action to a particular entity, consult NRDC—National Resources Defense documents. All documents in the docket the person listed under FOR FURTHER Council are listed in the docket index available INFORMATION CONTACT. OP—Organophosphate in regulations.gov. Although listed in B. How Can I Access Electronic Copies ORD—Office of Research and the index, some information is not of this Document? Development publicly available, e.g., Confidential PAD—Population Adjusted Dose Business Information (CBI) or other In addition to accessing an electronic PCA—Percent Cropped Area information whose disclosure is copy of this Federal Register document PCT—Percent Crop Treated restricted by statute. Certain other through the electronic docket at http:// PDP—Pesticide Data Program material, such as copyrighted material, www.regulations.gov, you may access PND—Post-Natal Day is not placed on the Internet and will be this Federal Register document PNS—Peripheral Nervous System publicly available only in hard copy electronically through the EPA Internet PoD—Point of Departure form. Publicly available docket under the Federal Register listings at ppb—parts per billion materials are available in the electronic http://www.epa.gov/fedrgstr. You may ppm—parts per million docket at http://www.regulations.gov, also access a frequently updated PRZM–EXAMS—Pesticide Root Zone or, if only available in hard copy, at the electronic version of EPA’s tolerance Model-Exposure Analysis Model OPP Regulatory Public Docket in Rm. S– regulations at 40 CFR part 180 through System 4400, One Potomac Yard (South Bldg.), the Government Printing Office’s pilot RBC—red blood cell 2777 S. Crystal Dr., Arlington, VA. The e-CFR site at http://www.gpoaccess.gov/ RED—Reregistration Eligibility Decision Docket Facility is open from 8:30 a.m. ecfr. RfD—Reference Dose to 4 p.m., Monday through Friday, C. Acronyms SAP—Scientific Advisory Panel excluding legal holidays. The Docket SDWA—Safe Drinking Water Act The following is a list of acronyms Facility telephone number is (703) 305– USDA—United States Department of used in this order: 5805. Agriculture AChE—Acetylcholinesterase FOR FURTHER INFORMATION CONTACT: USGS—United States Geological Survey Jude aPAD—Acute Population Adjusted Dose Andreasen, Pesticide Re-evaluation WARP—Watershed Regression for BMD—Bench Mark Dose Pesticides Division (7508P), Office of Pesticide BMDL—Bench Mark Dose Level Programs, Environmental Protection CCA—Comparative Cholinesterase II. Introduction Agency, 1200 Pennsylvania Ave., NW., Assay A. What Action Is the Agency Taking? Washington, DC 20460–0001; telephone CNS—Central Nervous System number: (703) 308–9342; e-mail address: CRA—Cumulative Risk Assessment Exposure to the pesticide carbofuran [email protected]. CSFII—Continuing Survey of Food resulting from existing legal uses is SUPPLEMENTARY INFORMATION: Intakes by Individuals unsafe—unsafe for the general
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population, and particularly unsafe for Petitioners involved EPA’s decision on for granting a hearing and none of the infants and children. EPA reached this the appropriate level of the additional Petitioners’ objections has merit. There conclusion in 2006 after an exhaustive safety factor to protect infants and are numerous reasons for these multi-year review of the data on children, EPA’s estimate of carbofuran conclusions, but two related themes carbofuran as part of its effort to levels in drinking water, EPA’s running throughout EPA’s analysis are determine whether carbofuran should consideration of the time needed to the Petitioners’ failure to timely raise be reregistered under the Federal recover from exposure to carbofuran, issues or submit supporting documents Insecticide, Fungicide, and Rodenticide and EPA’s refusal to consider a human during the public comment process on Act (‘‘FIFRA’’), and whether the toxicity study conducted with the proposed rule and the Petitioners’ tolerances allowing carbofuran residues carbofuran. failure to object to how EPA, in the final on certain foods met the revised safety Today’s order denies all of the rule, resolved the issues the Petitioners standard in section 408 of the FFDCA. Petitioners’ objections and requests for did raise in the comment process. EPA This multi-year review included hearing. A principal flaw in the considers issues untimely raised to be multiple opportunities for public Petitioners’ objections is that they have waived—as EPA clearly warned at the participation, including no less than objected to EPA’s determination in the proposal stage—and finds recycled four formal public comment periods. final rule on the safety of carbofuran comments on the proposed rule to be Following EPA review of yet more based on the FIFRA registration irrelevant to the detailed determinations carbofuran data submitted by FMC, the amendments that FMC filed with EPA made in the final rule. The rulemaking carbofuran registrant, and the review of 45 days after the safety determination phase of the revocation process has a EPA’s science findings by the FIFRA was made. As such, the Petitioners’ purpose, and parties treat it lightly at Scientific Advisory Panel (SAP)—an objections are irrelevant, and thus their peril. Finally, EPA notes that an independent scientific peer review immaterial, to the determination EPA additional problem with the Petitioners’ panel—EPA again reached the same made in the final rule. FMC has the objections is that once the newly conclusion in its July 31, 2008 proposal statutory right under FIFRA to request proposed registration amendments are to revoke the carbofuran tolerances (73 amendment of its carbofuran stripped from the objections, it is not at FR 44864 (July 31, 2008)). In response registration. What Petitioners may not all clear that any remaining issues, even to this proposed revocation, FMC do is prolong the FFDCA tolerance if concluded in the Petitioners’ favor, submitted comments challenging many revocation process by challenging EPA’s would result in lowering carbofuran’s of EPA’s science findings and also safety determination based on proposed estimated risks—which EPA has requesting the cancellation of the FIFRA registration changes not before estimated as far exceeding the safety registration of carbofuran on several EPA at the time of its final revocation standard—to an acceptable level. For all crops and the restriction of where, and decision. of these reasons, the Petitioners’ It should be noted that EPA’s decision the manner in which, carbofuran could objections and hearing requests are on the carbofuran tolerances is not a be used in the United States on its denied. determination on FMC’s proposed remaining registered crop sites. Finding registration amendments. FMC may B. What Is the Agency’s Authority for FMC’s science arguments to be flawed continue to pursue these amendments Taking This Action? and its proposed amendments to the and also the re-establishment of carbofuran registration to be EPA is taking this action pursuant to carbofuran tolerances in light of the insufficient, EPA finalized the rule the authority in FFDCA section amendments. Further, FMC may seek revoking carbofuran tolerances on May 408(g)(2)(C), which requires the Agency administrative review, and potentially 15, 2009 (74 FR 23046 (May 15, 2009)). to issue a final order resolving the an administrative hearing, with regard objections to its final rule, issued Pursuant to the procedures of the to any adverse decision issued by EPA pursuant to 408(b)(1)(b), 408(b)(2)(A), FFDCA, on June 29, 2009 objections to on its proposed amendments. But that and 408(e)(1)(A). 21 U.S.C. the final revocation rule were filed by process must be played out in the 346a(b)(1)(b), (b)(2)(A), (e)(1)(A), the National Corn Growers Association, future, a future in which any decision (g)(2)(C).) National Sunflower Association, about the safety of carbofuran is made National Potato Council, and FMC prior to the re-introduction of III. Statutory and Regulatory Corporation (‘‘Petitioners’’). The carbofuran residues in food and water, Background Petitioners also requested a hearing on rather than concurrent with the In this Unit, EPA provides their objections. Coupled with these continued exposure of infants and background on the relevant statutes and objections, FMC filed on the same day children to levels of carbofuran residues regulations governing the Petitioners’ yet another series of proposed that EPA has found to be unsafe. objections and requests for hearing as amendments to its carbofuran Despite the fact that a central aspect well as on pertinent Agency policies registration. These proposed of the Petitioners’ objections is based on and practices. modifications contained new a flawed conception of the objection application and geographic restrictions process (i.e., the notion that the A. FFDCA/FIFRA and Applicable as well as an unprecedented non- objection process presents the Regulations governmental scheme for preventing the opportunity for a complete 1. In general. EPA establishes use of carbofuran in any one area of the reformulation of the matter in dispute, maximum residue limits, or country above a small percentage of that rather than a chance for a review of the ‘‘tolerances,’’ for pesticide residues in area’s agricultural acreage. The accuracy of EPA’s earlier food under section 408 of the FFDCA Petitioners relied on these proposed determination), EPA has undertaken a (21 U.S.C. 346a). Without such a carbofuran registration amendments as comprehensive analysis of the merits of tolerance or an exemption from the central to, and inextricably intertwined each of the Petitioners’ objections and requirement of a tolerance, a food with, their objection to EPA’s prior hearing requests. That analysis shows, containing a pesticide residue is determination in the final rule that as is exhaustively set out in Unit VI, that ‘‘adulterated’’ under section 402 of the carbofuran tolerances are unsafe. none of the Petitioners’ requests for FFDCA and may not be legally moved Specific challenges raised by the hearing meets the regulatory standard in interstate commerce (21 U.S.C. 331,
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342). Monitoring and enforcement of related substances, including dietary ‘‘with particularity the provisions of the pesticide tolerances are carried out by exposure under the tolerance and all regulation * * * deemed objectionable the U.S. Food and Drug Administration other tolerances in effect for the and stating reasonable grounds (‘‘FDA’’) and the U.S. Department of pesticide chemical residue, and therefore’’ (21 U.S.C. 346a(g)(2)(A); 40 Agriculture (‘‘USDA’’). Section 408 was exposure from other non-occupational CFR 178.25(a)). Objections and hearing substantially rewritten by the Food sources; requests must be filed within 60 days Quality Protection Act of 1996 EPA must also consider, in evaluating (Id.). The statute provides that EPA shall (‘‘FQPA’’), which added the provisions the safety of tolerances, ‘‘safety factors ‘‘hold a public evidentiary hearing if discussed below establishing a detailed which * * * are generally recognized as and to the extent the Administrator safety standard for pesticides, additional appropriate for the use of animal determines that such a public hearing is protections for infants and children, and experimentation data.’’ (21 U.S.C. necessary to receive factual evidence the process for establishing or revoking 346a(b)(2)(D)(ix).) relevant to material issues of fact raised tolerances (Pub. L. 104–170, 110 Stat. Risks to infants and children are given by the objections’’ (21 U.S.C. 1489 (1996)). special consideration. Specifically, 346a(g)(2)(B)). EPA regulations make EPA also regulates pesticides under section 408(b)(2)(C) states that EPA: the Federal Insecticide, Fungicide, and clear that hearings will only be granted Rodenticide Act (‘‘FIFRA’’) (7 U.S.C. Shall assess the risk of the pesticide where it is shown that there is ‘‘a 136 et seq.). While the FFDCA chemical based on—* * * genuine and substantial issue of fact;’’ authorizes the establishment of legal (II) Available information concerning the the requestor has identified evidence limits for pesticide residues in food, special susceptibility of infants and children ‘‘which, if established, will resolve one FIFRA requires the approval of to the pesticide chemical residues, including or more of such issues in favor of the pesticides prior to their sale and neurological differences between infants and requestor,’’ and the issue is children and adults, and effects of in utero ‘‘determinative’’ with regard to the relief distribution (7 U.S.C. 136a(a)), and exposure to pesticide chemicals; establishes a registration regime for requested (40 CFR 178.32(b)). After regulating the use of pesticides. FIFRA (21 U.S.C. 346a(b)(2)(C)(i)(II) and consideration of any objections, EPA regulates pesticide use in conjunction (III)). This provision also creates a must issue a final order stating the with its registration scheme by requiring presumptive additional safety factor for action taken in response to each EPA review and approval of pesticide the protection of infants and children. objection, including a determination as labels and specifying that use of a Specifically, it directs that ‘‘[i]n the case to whether any hearing is appropriate pesticide inconsistent with its label is a of threshold effects, * * * an additional (21 U.S.C. 346a(g)(2)(C)). The final order tenfold margin of safety for the pesticide violation of federal law (7 U.S.C. also establishes any revisions to the chemical residue and other sources of 136j(a)(2)(G)). In the FQPA, Congress final regulation EPA deems to be exposure shall be applied for infants integrated action under the two statutes warranted based on the objections. Id. and children to take into account by requiring that the safety standard EPA’s final order on the objections is potential pre- and post-natal toxicity under the FFDCA be used as a criterion subject to judicial review in the Court of in FIFRA registration actions as to and completeness of the data with respect to exposure and toxicity to Appeals, within 60 days of the pesticide uses that result in dietary risk publication of the order (21 U.S.C. from residues in or on food (7 U.S.C. infants and children’’ (21 U.S.C. 346a(h)(1)). 136(bb)), and directing that EPA 346a(b)(2)(C)). EPA is permitted to ‘‘use coordinate, to the extent practicable, a different margin of safety for the 4. Tolerance reassessment and FIFRA revocations of tolerances with pesticide pesticide chemical residue only if, on reregistration. EPA revoked the cancellations under FIFRA. (21 U.S.C. the basis of reliable data, such margin carbfuran tolerances to implement the 346a(l)(1)). will be safe for infants and children’’ Agency’s findings made during the 2. Safety standard for pesticide (Id.). The additional safety margin for reregistration and tolerance tolerances. Section 408(b)(2)(A)(i) of the infants and children is referred to reassessment processes. FFDCA requires EPA to modify or throughout this order as the ‘‘children’s The FQPA required that EPA reassess revoke a tolerance if EPA determines safety factor.’’ the safety of all pesticide tolerances 3. Procedures for establishing, that the tolerance is not ‘‘safe’’ (21 existing at the time of its enactment. (21 amending, or revoking tolerances. U.S.C. 346a(b)(2)(A)(ii)). Section U.S.C. 346a(q)). EPA was given 10 years 408(b)(2)(A)(ii) of the FFDCA defines Tolerances are revoked by rulemaking to reassess the approximately 10,000 ‘‘safe’’ to mean that ‘‘there is a under the unique procedural framework tolerances in existence in 1996. In this reasonable certainty that no harm will set forth in the FFDCA. Section 408(e) reassessment, EPA was required to result from aggregate exposure to the of the FFDCA, 21 U.S.C. 346a(e), review existing pesticide tolerances pesticide chemical residue, including authorizes EPA to modify or revoke all anticipated dietary exposures and all tolerances on its own initiative. under the new ‘‘reasonable certainty other exposures for which there is In issuing a regulation on its own that no harm will result’’ standard set reliable information.’’ This includes initiative, EPA must first publish a forth in section 408(b)(2)(A)(i). (21 exposure through drinking water and in notice of proposed rulemaking, and U.S.C. 346a(b)(2)(A)(i)). This residential settings, but does not include must generally provide at least 60 days reassessment was substantially occupational exposure. Section to allow the public to comment on the completed by the August 3, 2006 408(b)(2)(D) directs EPA, in making a proposed regulation. After considering deadline. Tolerance reassessment was safety determination, to: comments submitted during this generally handled in conjunction with a Consider, among other relevant comment period, EPA issues a final similar program involving reregistration factors—* * * rule. of pesticides under FIFRA. (7 U.S.C. (vi) Available information concerning Once EPA issues a final rule, any 136a–1). Reassessment and the aggregate exposure levels of person may file objections with EPA reregistration decisions were generally consumers (and major identifiable and, if desired, request an evidentiary combined in a document labeled a subgroups of consumers) to the hearing on those objections (21 U.S.C. Reregistration Eligibility Decision pesticide chemical residue and to other 346a(g)(2)). Objections must specify (RED).
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B. EPA’s Human Research Rule Whether the data are ‘‘new’’ or ‘‘old,’’ on comparison of human exposure to EPA decisions regarding the use of the Human Research rule forbids EPA the level of concern. from relying on data from any study human studies in pesticide regulatory A. Hazard Identification and Selection involving intentional exposure of decisions are governed by the Protection of Toxicological Endpoint for Subjects in Human Research final pregnant women, fetuses, or children 1. In General. Any risk assessment rule (‘‘Human Research rule’’), which subject to a very limited exception (40 begins with an evaluation of a significantly strengthened and CFR 26.1703, 1706). chemical’s inherent properties, and expanded protections for subjects of To aid EPA in making scientific and whether those properties have the human research (71 FR 6138 (February ethical determinations under the potential to cause adverse effects (i.e., 6, 2006)). The framework of the Human Human Research rule, the rule established an independent Human hazard identification). EPA then Research rule rests on the basic Studies Review Board (HSRB) to review evaluates the hazards to determine the principle that EPA will not, in its both proposals for new research (new most sensitive and appropriate adverse actions, rely on data derived from studies) and reports of completed effect of concern, based on factors such unethical research. The rule divides human research (old studies) on which as the effect’s relevance to humans and studies involving intentional dosing of EPA proposes to rely (40 CFR 26.1603). the likely routes of exposure. human subjects into two groups: ‘‘new’’ The rule directs that the HSRB shall be Once a pesticide’s potential hazards studies—those initiated after April 7, comprised of non-EPA employees ‘‘who are identified, EPA determines a 2006 (the effective date of the rule)— have expertise in fields appropriate for toxicological level of concern for and ‘‘old’’ studies—those initiated the scientific and ethical review of evaluating the risk posed by human before April 7, 2006. The Human human research, including research exposure to the pesticide. In this step of Research Rule forbids EPA from relying ethics, biostatistics, and human the risk assessment process, EPA on data from any ‘‘new’’ study, unless toxicology’’ (40 CFR 26.1603(a)). If EPA essentially evaluates the levels of EPA has adequate information to decides to rely on the results from ‘‘old’’ exposure to the pesticide at which determine that the research was research conducted to identify or effects might occur. An important aspect conducted in substantial compliance measure a toxic effect, EPA must submit of this determination is assessing the with the ethical requirements contained the results of its assessment to the HSRB relationship between exposure (dose) therein (40 CFR 26.1705). These ethical for evaluation of the ethical and and response (often referred to as the rules are derived primarily from the scientific merit of the research (40 CFR dose-response analysis). In evaluating a ‘‘Common Rule,’’ (40 CFR part 26), a 26.1602(b)(2)). chemical’s dietary risks EPA uses a rule setting ethical parameters for EPA has established the HSRB as a reference dose (RfD) approach, which studies conducted or supported by the federal advisory committee under the involves a number of considerations federal government. In addition to Federal Advisory Committee Act including: requiring informed consent and (FACA) to take advantage of ‘‘the • A ‘point of departure’ (PoD)—the protection of the safety of the subjects, benefits of the transparency and value from a dose-response curve that is among other things, the rule specifies opportunities for public participation’’ at the low end of the observable data that ‘‘[r]isks to subjects [must be] that accompany a FACA committee (71 and that is the dose that serves as the reasonable in relation to * * * the FR at 6156). The HSRB, as appointed by ‘starting point’ in extrapolating a risk to importance of the knowledge that may EPA, contains approximately 16 the human population; reasonably be expected to result [from distinguished experts in the fields of • An uncertainty factor to address the the study].’’ (40 CFR 26.1111(a)(2)). In bioethics, biostatistics, human health potential for a difference in toxic other words, a study would be judged risk assessment and human toxicology, response between humans and animals unethical if it did not have scientific primarily from academia (Ref. 10). used in toxicity tests (i.e., interspecies value outweighing any risks to the test extrapolation); subjects. IV. EPA’s Approach to Dietary Risk • An uncertainty factor to address the As to ‘‘old’’ studies, the Human Assessment potential for differences in sensitivity in Research Rule forbids EPA from relying EPA performs a number of analyses to the toxic response across the human on such data if there is clear and determine the risks from aggregate population (i.e., intraspecies convincing evidence that the conduct of exposure to pesticide residues. A short variability); and the research was fundamentally summary is provided below to aid the • The need for an additional safety unethical or significantly deficient with reader. For further discussion of the factor to protect infants and children, as respect to the ethical standards regulatory requirements of section 408 specified in FFDCA section 408(b)(2)(C). prevailing at the time the research was of the FFDCA and a complete EPA uses the chosen PoD to calculate conducted (40 CFR 26.1704). EPA has description of the risk assessment a safe dose or RfD. The RfD is calculated indicated that in evaluating ‘‘the ethical process, see http://www.epa.gov/ by dividing the chosen PoD by all standards prevailing at the time the fedrgstr/EPA-PEST/1999/January/Day- applicable safety or uncertainty factors. research was conducted’’ it will 04/p34736.htm. Typically in EPA risk assessments, a consider the Nuremburg Code, various To assess the risk of a pesticide combination of safety or uncertainty editions of the Declaration of Helsinki, tolerance, EPA combines information on factors providing at least a hundredfold the Belmont Report, and the Common pesticide toxicity with information (100X) margin of safety is used: 10X to Rule, as among the standards that may regarding the route, magnitude, and account for interspecies extrapolation be applicable to any particular study (71 duration of exposure to the pesticide. and 10X to account for intraspecies FR at 6161). Further, reflecting the The risk assessment process involves variability. Further, as required by concern that scientifically invalid data four distinct steps: (1) Identification of FFDCA section 408(b)(2)(C), in are ‘‘always unethical,’’ (71 FR at 6160), the toxicological hazards posed by a evaluating the dietary risks for pesticide the rule limits the human research that pesticide; (2) determination of the chemicals, an additional safety factor of can be relied upon by EPA to exposure ‘‘level of concern’’ for humans; 10X is presumptively applied to protect ‘‘scientifically valid and relevant data’’ (3) estimation of human exposure; and infants and children, unless reliable (40 CFR 26.1701). (4) characterization of human risk based data support selection of a different
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factor. In implementing FFDCA section between nerve cells in the brain or in not an adverse effect, but may indicate 408, EPA also calculates a variant of the the autonomic ganglia of the peripheral a potential for adverse effects on the RfD referred to as a Population Adjusted nervous system.’’ (Ref. 78 at 10). nervous system’’ (Id. at 28). The policy Dose (PAD). A PAD is the RfD divided AChE is an enzyme that breaks down states that ‘‘[a]s a matter of science by any portion of the children’s safety acetylcholine and terminates its policy, blood AChE data are considered factor that does not correspond to one stimulating action in the synapse appropriate surrogate measures of of the traditional additional uncertainty/ between nerve cells and target cells. potential effects on peripheral nervous safety factors used in general Agency When AChE is inhibited, acetylcholine system AChE activity in animals, for risk assessment. The reason for builds up prolonging the stimulation of central nervous system (‘‘CNS’’) AChE calculating PADs is so that other parts the target cell. This excessive activity in animals when CNS data are of the Agency, which are not governed stimulation potentially results in a lacking and for both peripheral and by FFDCA section 408, can, when broad range of adverse effects on many central nervous system AChE in evaluating the same or similar bodily functions including muscle humans’’ (Id. at 29). The policy notes substances, easily identify which cramping or paralysis, excessive that ‘‘there is often a direct relationship aspects of a pesticide risk assessment glandular secretions, or effects on between a greater magnitude of are a function of the particular statutory learning, memory, or other behavioral exposure [to a AChE-inhibiting commands in FFDCA section 408. For parameters. Depending on the degree of pesticide] and an increase in incidence acute assessments, the risk is expressed inhibition these effects can be serious, and severity of clinical signs and as a percentage of a maximum even fatal. symptoms as well as blood AChE acceptable dose or the acute PAD (i.e., EPA’s cholinesterase inhibition policy inhibition’’ (Id. at 30). Thus, the policy the acute dose which EPA has statement explains EPA’s approach to regards blood AChE data as concluded will be ‘‘safe’’). As discussed evaluating the risks posed by AChE- ‘‘appropriate endpoints for derivation of below in Unit V.C., dietary exposures inhibiting pesticides such as carbofuran reference doses or concentrations when greater than 100 percent of the acute (Ref. 78 at 10). The policy focuses on considered in a weight-of-the-evidence PAD are generally cause for concern and three types of effects associated with analysis of the entire database * * *’’ would be considered ‘‘unsafe’’ within AChE-inhibiting pesticides that may be (Id. at 29). Between AChE inhibition the meaning of FFDCA section assessed in animal and human measured in red blood cell (‘‘RBC’’) or 408(b)(2)(B). Throughout this document toxicological studies: (1) Physiological blood plasma, the policy states a general references to EPA’s calculated and behavioral/functional effects; (2) preference for reliance on RBC AChE safe dose are denoted as an acute PAD, AChE inhibition in the central and measurements because plasma is or aPAD, because the relevant point of peripheral nervous system; and (3) composed of a mixture of departure for carbofuran is based on an AChE inhibition in red blood cells and acetylcholinesterase and acute risk endpoint. blood plasma. The policy discusses how butyrylcholinesterase, and inhibition of 2. Acetylcholinesterase Inhibition. such data should be integrated in the latter is less clearly tied to inhibition Carbofuran is a member of the class of deriving an acceptable dose (RfD/PAD) of acetylcholinesterase in the nervous pesticides called N-methyl carbamates for a AChE-inhibiting pesticide. system (Id. at 29, 32). (NMCs). The primary toxic effect caused After clinical signs or symptoms, EPA has relied on a benchmark dose by NMCs, including carbofuran, is AChE inhibition in the nervous system (BMD) approach for deriving the PoD neurotoxicity resulting from inhibition provides the next most important from the available rat toxicity studies. A of the enzyme acetylcholinesterase endpoint for evaluating AChE-inhibiting BMD is a point estimate along a dose- (AChE). The toxicity profile of these pesticides. Although AChE inhibition in response curve that corresponds to a pesticides is characterized by rapid time the nervous system is not itself regarded specific response level. For example, a to onset of effects followed by rapid as a direct adverse effect, it is ‘‘generally BMD10 represents a 10% change from recovery (minutes to hours). Consistent accepted as a key component of the the background; 10% is often used as a with its mechanism of action, toxicity mechanism of toxicity leading to typical value for the response of concern data on AChE inhibition from laboratory adverse cholinergic effects’’ (Id. at 25). (Ref. 76). Generically, the direction of rats provide the basis for deriving the As such, the policy states that it should change from background can be an PoD for carbofuran. be treated as ‘‘direct evidence of increase or a decrease depending on the AChE inhibition is a disruption of the potential adverse effects’’ and ‘‘data biological parameter and the chemical normal process in the body by which showing this response provide valuable of interest. In the case of carbofuran, the nervous system chemically information in assessing potential inhibition of AChE is the toxic effect of communicates with muscles and glands. hazards posed by antiAChE pesticides’’ concern. Following exposure to Communication between nerve cells (Id.). Unfortunately, useful data carbofuran, the normal biological and a target cell (i.e., another nerve cell, measuring AChE inhibition in the activity of the AChE enzyme is a muscle fiber, or a gland) is facilitated peripheral nervous system tissues has decreased (i.e., the enzyme is inhibited). by the chemical, acetylcholine. When a only been relatively rarely captured by Thus, when evaluating BMDs for nerve cell is stimulated it releases standard toxicology testing, particularly carbofuran, the Agency is interested in acetylcholine into the synapse (or space) for the NMC compounds. For central a decrease in AChE activity compared to between the nerve cell and the target nervous system effects, however, more normal activity levels, which are also cell. The released acetylcholine binds to recent neurotoxicity studies ‘‘have termed ‘‘background’’ levels. receptors in the target cell, stimulating sought to characterize the time course of Measurements of ‘‘background’’ AChE the target cell in turn. As EPA has inhibition in * * * [the] brain, activity levels are usually obtained from explained, ‘‘the end result of the including brain regions, after acute and animals in experimental studies that are stimulation of cholinergic pathway(s) 90-day exposures’’ (Id. at 27). not treated with the pesticide of interest includes, for example, the contraction of AChE inhibition in the blood is one (i.e., ‘‘negative control’’ animals). smooth (e.g., in the gastrointestinal step further removed from the direct In addition to the BMD, a confidence tract) or skeletal muscle, changes in harmful consequences of AChE- limit was also calculated. Confidence heart rate or glandular secretion (e.g., inhibiting pesticides. According to the limits express the uncertainty in a BMD sweat glands) or communication policy, inhibition of blood AChEs ‘‘is that may be due to sampling and/or
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experimental error. The lower distributions of potential exposures in values for a particular pesticide and the confidence limit on the dose used as the the population for each route or RfD or PADs for that pesticide are BMD is termed the BMDL, which the pathway. For dietary analyses, the inputs to the DEEM–FCID computer Agency uses as the PoD. Use of the relevant sources of potential exposure to program to estimate exposure and risk. BMDL for deriving the PoD rewards carbofuran are from the ingestion of The DEEM–FCID computer program better experimental design and residues in food and drinking water. estimates exposure by combining data procedures that provide more precise The Agency uses a combination of on human consumption amounts with estimates of the BMD, resulting in monitoring data and predictive models residue values in food commodities. tighter confidence intervals. Use of the to evaluate environmental exposure of DEEM–FCID also compares exposure BMDL also helps ensure with high humans to carbofuran. estimates to appropriate RfD or PAD confidence (e.g., 95% confidence) that 1. Exposure from Food. The level of values to estimate risk. EPA uses the selected percentage of AChE human exposure to pesticide residues in DEEM–FCID to estimate exposure for inhibition is not exceeded. From the food is a function of both the pesticide the general U.S. population as well as PoD, EPA calculates the RfD and aPAD. residues in food and the amount of food for 32 subgroups based on age, sex, Specific to carbofuran and the other consumed. Data on the residues of ethnicity, and region. DEEM–FCID NMCs, EPA the FIFRA SAP has carbofuran in foods are available from a allows EPA to process extensive reviewed and supported the statistical variety of sources. One of the primary volumes of data on human consumption methods used to derive the BMD and sources of data comes from federally- amounts and residue levels in making BMDLs on multiple occasions (Refs. 34, conducted surveys, including the risk estimates. Matching consumption 35, 36). Pesticide Data Program (PDP) conducted and residue data, as well as managing In the Agency’s BMD analysis for by the USDA. Further, market basket the thousands of repeated analyses of carbofuran, EPA used a response level surveys, which are typically performed the consumption database conducted of 10% brain AChE inhibition; this by registrants, can provide additional under probabilistic risk assessment value represents the estimated dose residue data. These data generally techniques, requires the use of a where AChE is inhibited by 10%, provide a characterization of pesticide computer. compared to untreated animals. For the residues in or on foods consumed by the For carbofuran’s assessment, EPA last several years EPA has used the 10% U.S. population that closely used DEEM–FCID to calculate risk value to regulate AChE inhibiting approximates real world exposures estimates based on a probabilistic pesticides, including because they are sampled closer to the distribution. DEEM–FCID combines the organophosphorous pesticides (OPs) point of consumption in the chain of full range of residue values for each and NMCs. For a variety of toxicological commerce than field trial data, which food with the full range of data on and statistical reasons, EPA chose 10% are generated to establish the maximum individual consumption amounts to brain AChE inhibition as the response level of legal residues that could result create a distribution of exposure and level for use in BMD calculations. EPA from maximum permissible use of the risk levels. More specifically, DEEM– analyses have demonstrated that 10% is pesticide. In certain circumstances, FCID creates this distribution by a level that can be reliably measured in when EPA believes the information will calculating an exposure value for each the majority of rat toxicity studies; is provide more accurate exposure reported day of consumption per person generally at or near the limit of estimates, EPA will rely on field trial (‘‘person/day’’) in CSFII, assuming that sensitivity for discerning a statistically data (see below in Unit VI.E.1). all foods potentially bearing the significant decrease in AChE activity EPA relies on USDA’s Continuing pesticide residue contain such residue across the brain compartment; and is a Survey of Food Intake by Individuals response level close to the background (CSFII) for information on food at a value selected randomly from the (Refs. 34, 35). consumption by the US population as exposure data sets. The exposure well as 32 subgroups based on age, amounts for the thousands of person/ B. Estimating Human Dietary Exposure gender, ethnicity, and region. The latest days in the CSFII are then collected in Levels CSFII was conducted in 1994–1996 and a frequency distribution. EPA also uses Pursuant to section 408(b) of the 1998. The 1998 survey was a special DEEM–FCID to compute a distribution FFDCA, EPA has evaluated carbofuran’s survey required by the FQPA to taking into account both the full range dietary risks based on ‘‘aggregate supplement the number of children of data on consumption levels and the exposure’’ to carbofuran. By ‘‘aggregate survey participants. DEEM–FCID also full range of data on potential residue exposure,’’ EPA is referring to exposure contains ‘‘recipes’’ that convert foods as levels in food. Combining consumption to carbofuran by multiple pathways of consumed (e.g., pizza) back into their and residue levels into a distribution of exposure. EPA uses available data and component raw agricultural potential exposures and risk requires standard analytical methods, together commodities (e.g., wheat from flour, or use of probabilistic techniques. with assumptions designed to be tomatoes from sauce, etc.). This is The probabilistic technique that protective of public health, to produce necessary because residue data are DEEM–FCID uses to combine differing separate estimates of exposure for a generally gathered on raw agricultural levels of consumption and residues highly exposed subgroup of the general commodities rather than on finished involves the following steps: population, for each potential pathway ready-to-eat food. Data on residue (1) Identification of any food(s) that and route of exposure. For acute risks, could bear the residue in question for EPA then calculates potential aggregate information on the range and probability of possible each person/day in the CSFII; exposure and risk by using exposure and their associated risk values’’ (Ref. 77). (2) Calculation of an exposure level In capsule, a probabilistic pesticide exposure 1 for each of the thousands of person/days probabalistic techniques to combine analysis constructs a distribution of potential exposures based on data on consumption patterns in the CSFII database, based on the 1 Probabilistic analysis is used to predict the and residue levels and provides a ranking of the foods identified in Step #1 by randomly frequency with which variations of a given event probability that each potential exposure will occur. selecting residue values for the foods will occur. By taking into account the actual People consume differing amounts of the same from the residue database; distribution of possible consumption and pesticide foods, including none at all, and a food will contain residue values, probabilistic analysis for pesticide differing amounts of a pesticide residue, including (3) Repetition of Step #2 one thousand exposure assessments ‘‘provides more accurate none at all. times for each person/day; and
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(4) Collection of all of the hundreds periods of time, and for places that are fluctuate daily, seasonally, and yearly as of thousands of potential exposures of most interest for any particular a result of the timing of pesticide estimated in Steps ##2 and 3 in a pesticide. applications, the vulnerability of the frequency distribution. EPA relies on models it has developed water supply to pesticide loading The resulting probabilistic assessment for estimating pesticide concentrations through runoff, spray drift and/or presents a range of exposure/risk in both surface water and ground water. leaching, and changes in the weather. estimates. Typically EPA uses a two-tiered Concentrations are also affected by the 2. Exposure from water. EPA may use approach to modeling pesticide method of application, the location and field monitoring data and/or simulation concentrations in surface and ground characteristics of the sites where a water exposure models to generate water. If the first tier model suggests pesticide is used, the climate, and the pesticide concentration estimates in that pesticide levels in water may be type and degree of pest pressure. drinking water. Monitoring and unacceptably high, a more refined EPA uses the output of daily modeling are both important tools for model is used as a second tier concentration values from tier two estimating pesticide concentrations in assessment. The second tier model for modeling as an input to DEEM–FCID, water and can provide different types of surface water is actually a combination which combines water concentrations information. Monitoring data can of two models: The Pesticide Root Zone with drinking water consumption provide estimates of pesticide Model (PRZM) and the Exposure information in the daily diet to generate concentrations in water that are Analysis Model System (EXAMS). The a distribution of exposures from representative of the specific second tier model for ground water uses consumption of drinking water agricultural or residential pesticide PRZM alone. contaminated with pesticides. These practices in specific locations, under the A detailed description of the models results are then used to calculate a environmental conditions associated routinely used for exposure assessment probabilistic assessment of the aggregate with a sampling design (i.e., the is available from the EPA OPP Water human exposure and risk from residues locations of sampling, the times of the Models Web site: http://www.epa.gov/ in food and drinking water. year samples were taken, and the oppefed1/models/water/index.htm. 3. Aggregate Exposure Analyses. frequency by which samples were These models provide a means for EPA Using probabilistic analyses, EPA collected). Although monitoring data to estimate daily pesticide combines the national food exposures can provide a direct measure of the concentrations in surface water sources with the exposures derived for concentration of a pesticide in water, it of drinking water (a reservoir) using individual region and crop-specific does not always provide a reliable basis local soil, site, hydrology, and weather drinking water scenarios to derive for estimating spatial and temporal characteristics along with pesticide estimates of aggregate exposure. variability in exposures because application and agricultural Although food is distributed nationally, sampling may not occur in areas with management practices, and pesticide and exposures to pesticide residues are the highest pesticide use, and/or when environmental fate and transport therefore not expected to vary the pesticides are being used and/or at properties. Consistent with the substantially throughout the country, an appropriate sampling frequency to recommendations of the FIFRA SAP, drinking water is locally derived and detect high concentrations of a pesticide EPA also considers regional percent consumed and there can be significant that occur over the period of a day to cropped area factors (PCA) which take variations in pesticide levels in local several days. into account the potential extent of watersheds due to geographic, climatic, Because of the limitations in most cropped areas that could be treated with and other factors. To be protective of all monitoring studies, EPA’s standard pesticides in a particular area. The population subgroups, EPA uses approach is to use simulation water PRZM and EXAMS models used by EPA modeled estimates from vulnerable exposure models as the primary means were developed by EPA’s Office of watersheds in calculating aggregate to estimate pesticide exposure levels in Research and Development (ORD), and exposure. drinking water. Modeling is a useful are used by many international EPA’s standard acute dietary exposure tool for characterizing vulnerable sites, pesticide regulatory agencies to estimate assessment calculates total dietary and can be used to estimate peak pesticide exposure in surface water. exposure over a 24-hour period; that is pesticide water concentrations from EPA’s use of the percent cropped area consumption over 24 hours is summed infrequent, large rain events. EPA’s factors and the Index Reservoir scenario and no account is taken of the fact that computer models use detailed was reviewed and approved by the eating and drinking occasions may information on soil properties, crop FIFRA SAP in 1999 and 1998, spread out exposures over a day. This characteristics, and weather patterns to respectively (Refs. 30, 31). total daily exposure generally provides estimate water concentrations in In modeling potential surface water reasonable estimates of the risks from vulnerable locations where the pesticide concentrations, EPA attempts to model acute dietary exposures, given the could be used according to its label (69 areas of the country that are vulnerable nature of most chemical endpoints. Due FR 30042, 30058–30065 (May 26, to surface water contamination rather to the rapid recovery associated with 2004)). These models calculate than simply model ‘‘typical’’ carbofuran toxicity (AChE inhibition), estimated water concentrations of concentrations occurring across the 24-hour exposure periods may or may pesticides using laboratory data that nation. Consequently, EPA models not be appropriate. To the extent that a describe how fast the pesticide breaks exposures occurring in small, highly day’s eating or drinking occasions down to other chemicals and how it agricultural watersheds in different leading to high total daily exposure moves in the environment at these growing areas throughout the country, might be found close together in time, vulnerable locations. The modeling over a 30-year period. The scenarios are or to occur from a single eating event, provides an estimate of pesticide designed to capture residue levels in minimal AChE recovery would occur concentrations in ground and surface drinking water from reservoirs with between eating occasions (i.e., exposure water. Depending on the modeling small watersheds with a large events). In that case, the ‘‘24-hour sum’’ algorithm (e.g., surface water modeling percentage of land use in agricultural approach, which sums eating events scenarios), daily concentrations can be production. EPA’s models take into over a 24-hour period, would provide estimated continuously over long account that pesticide residues in water reasonable estimates of risk from food
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and drinking water. Conversely, to the exposure, EPA typically assumes that, The tolerance reassessment and extent that eating occasions leading to when the 99.9th percentile of acute FIFRA reregistration process for high total daily exposures are widely exposure is equal to or less than the carbofuran contained numerous separated in time (within one day) such aPAD, the level of concern for acute risk opportunities for public participation. that substantial AChE recovery occurs has not been exceeded. By contrast, These included public comment periods between eating occasions, then the where the analysis indicates that on the preliminary ecological risk estimated risks under any 24-hour sum estimated exposure at the 99.9th assessment (June–August 2005), the approach may be overstated. In that percentile exceeds the aPAD, EPA preliminary human health risk case, a more sophisticated approach— would generally conduct one or more assessment (September–November one that accounts for intra-day eating sensitivity analyses to determine the 2005), the revised combined risk and drinking patterns and the recovery extent to which the estimated exposures assessment (March–May 2006), and the of AChE between exposure events—may at the high-end percentiles may be interim Registration Eligibility be more appropriate. This approach is affected by unusually high food Document (RED) (August–November referred to as the ‘‘Eating Occasions consumption or residue values. To the 2006). EPA received over 200 comments Analysis’’ and it takes into account the extent that one or a few values seem to fact that the toxicological effect of a first ‘‘drive’’ the exposure estimates at the (plus a letter campaign supporting dose may be reduced or tempered prior high end of exposure, EPA would carbofuran with 2,896 signatories) to the to a second (or subsequent) dose. consider whether these values are 2006 RED. FMC submitted extensive Thus, rather than treating a full day’s reasonable and should be used as the comments throughout the process exposure as a one-time ‘‘bolus’’ dose, as primary basis for regulatory decision (including, but not limited to, a is typically done in the Agency’s making (Ref. 77). comment of 62 pages plus 13 assessments, the Eating Occasion attachments totaling over 900 pages on analysis uses the actual time of eating or V. Carbofuran Background and August 23, 2005, a letter with 20 drinking occasion, and amounts Regulatory History attachments on November 11, 2005, 46 consumed as reported by individuals to A. Tolerance Reassessment and pages of comments on January 26, 2006, the USDA CSFII. The actual CSFII- Pesticide Reregistration 78 pages of comments on February 17, recorded time of each eating event is 2006, a 15-page letter with 8 used to ‘‘separate out’’ the exposures In July 2006, EPA completed a refined attachments on May 22, 2006, over 200 acute probabilistic dietary risk due to each eating occasion; in doing so, pages on May 24, 2006, and other this ‘‘separation’’ allows the Agency to assessment for carbofuran as part of the submissions. Following issuance of the distinguish between each intake event tolerance reassessment program under RED in August 2006, FMC stated that and account for the fact that at least section 408(q) of the FFDCA and some partial recovery of AChE pesticide reregistration under section 4 they would be submitting new data to inhibition attributable to the first of FIFRA. The assessment was refute EPA’s ecological and human (earlier) exposure occurs before the conducted using Dietary Exposure health risk concerns, as well as EPA’s second exposure event. For chemicals Evaluation Model-Food Commodity benefits assessments. Twenty-three for which the toxic effect is rapidly Intake Database (DEEM–FCIDTM, submissions with studies and analyses reversible, the time between two (or Version 200–2.02), which incorporates were submitted in 2007, all of which more) exposure events permits partial to consumption data from the United EPA reviewed. FMC submitted 175 full recovery from the toxic effect from States Department of Agriculture’s pages of comments to the proposed the first exposure and it is this ‘‘partial (USDA’s) Nationwide Continuing tolerance revocations jointly with the recovery’’ that is specifically accounted Surveys of Food Intake by Individuals NPC, NCGA, NCC, and NSA on 9/29/09. for by the Eating Occasion Analysis. (CSFII), 1994–1996 and 1998, as well as The Agency has also met numerous More specifically, an estimated carbofuran monitoring data from times with FMC, growers, and other ‘‘persisting dose’’ from the first USDA’s Pesticide Data Program 2 (PDP), stakeholders regarding carbofuran. exposure event is added to the second estimated percent crop treated One particular aspect of the risk exposure event to account for the partial information, and processing/cooking assessment process that involved recovery of AChE inhibition that occurs factors, where applicable. The substantial public participation over the time between the first and assessment was conducted applying an opportunities was EPA’s review of the second exposures. The ‘persisting dose’ additional 500-fold safety factor that terminology, and this general approach included a 5X children’s safety factor, human toxicology studies performed were originally suggested by the FIFRA pursuant to section 408(b)(2)(C). That with carbofuran. In making a SAP in the context of assessing AChE refined assessment showed acute determination on whether these studies inhibition from cumulative exposures to dietary risks from carbofuran residues in met the standards of the Human OP pesticides (Ref. 33). food significantly above EPA’s level of Research rule, EPA, as required, sought the advice of the HSRB. The HSRB C. Selection of Acute Dietary Exposure concern (Ref. 14). Based in part on the review process includes the opportunity Level of Concern results of that assessment, EPA concluded that carbofuran failed to meet for the public both to submit written Because probabilistic assessments the revised safety standard in FFDCA comments and to make an oral generally are based on a realistic range section 408(b) and the standard for presentation to the HSRB. FMC gave of residue values to which the FIFRA reregistration.3 both written and oral comments at the population may be exposed, EPA’s HSRB meeting, which was held May 2– starting point for estimating exposure 2 USDA’s Pesticide Data Program monitors for 4, 2006. FMC also submitted written and risk for such aggregate assessments pesticides in certain foods at the distribution points comments on the final HSRB report on is the 99.9th percentile of the just before release to supermarkets and grocery the meeting. population under evaluation, which stores. 3 Although not relevant to this proceeding, in represents one person out of every 1000 addition to determining that use of carbofuran persons. When using a probabilistic resulted in unacceptable dietary risks, EPA standard for FIFRA registration based on method of estimating acute dietary concluded that use of carbofuran did not meet the unacceptable occupational and ecological risks.
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B. Draft Notice of Intent to Cancel Nebraska, ranged from 340% of the prohibited on much of the Eastern US Carbofuran Registrations aPAD for adults, to 3,900% aPAD for to protect vulnerable sources of In January 2008, EPA published a infants. EPA also determined that, based groundwater; use restrictions were draft Notice of Intent to Cancel (NOIC) on actual residue levels measured in imposed in other areas of the country, all carbofuran registrations, based in food in commerce, individual children preventing use within set distances to part on carbofuran’s dietary risks. As consuming typical amounts of a single prevent runoff into sources of surface mandated by FIFRA, EPA solicited food item received unsafe levels of water drinking water supplies. comments from the FIFRA Scientific carbofuran. For example, based on the On November 7, 2008, the Petitioners Advisory Panel (SAP) on its draft level of residues detected on in the food submitted additional information as a NOIC.4 As part of that process, EPA supply, a child between 3–5 years, who supplement to their September presented its dietary risk assessment of consumed 1⁄2 cup of cantaloupe, would comments. Specifically, they submitted carbofuran to the FIFRA SAP, and receive a dose ranging between 180% carbofuran use data that the Petitioners requested comment on key issues in the and 7,200% of the aPAD. Finally, the used in preparing its surface water risk assessment: The Agency’s approach proposal discussed a number of assessments. The information consisted to selecting the point of departure and sensitivity analyses the Agency had of a spreadsheet that contained all of the the children’s safety factor. FMC and the calculated in order to further data provided to the Water Panel by remaining Petitioners participated in characterize the potential risks to FMC, and a document that explained this meeting, making substantial children. Every one of these sensitivity the materials, methods, and procedures presentations to the SAP. As described analyses determined that estimated employed by the Panel to utilize this in the proposal, the Agency believes exposures significantly exceeded EPA’s data. that the Panel’s responses level of concern for children. On December 24, 2008, FMC unambiguously support the Agency’s EPA held a 60-day comment period submitted a petition requesting that EPA approach with regard to carbofuran’s on the proposed revocation rule. In the stay the effective date of the tolerance hazard identification and hazard proposed rule, EPA made clear that if revocations, and that EPA consider characterization (73 FR 44875 (July 31, any person had concerns with EPA’s additional information, including 2008)). In addition, EPA believes that, proposed revocation, those concerns further risk mitigation measure that the on balance, the application of a 4X must be raised during the comment registrant intended to implement, as children’s safety factor is consistent period to be preserved. Specifically, well as additional analyses that the with the SAP’s advice. Additional detail EPA stated: Petitioners’ experts were developing. on the SAP’s advice and EPA’s In addition to submitting comments in responses can be found at Ref. 83. E. Final Rule Revoking Carbofuran response to this proposal, you may also Tolerances C. Proposed Revocation of Carbofuran submit an objection at the time of the final rule. If you anticipate that you may wish to Tolerances On May 15, 2009, EPA published its file objections to the final rule, you must final rule, based on a revised risk Having considered the comments raise those issues in your comments on this assessment that addressed the voluntary from the SAP, EPA initiated the process proposal. EPA will treat as waived, any issue cancellations and label restrictions not originally raised in comments on this to revoke all carbofuran tolerances, submitted by the close of the September publishing a proposed revocation on proposal. Similarly, if you fail to file an objection to the final rule within the time 29 comment period. The only food uses July 31, 2008 (73 FR 44,864 (July 31, that remained registered after the 2008) (FRL–8378–8)). EPA proposed to period specified, you will have waived the right to raise any issues resolved in the final voluntary cancellations were revoke all of the existing tolerances for rule. After the specified time, issues resolved sunflowers, corn, potatoes, and residues of carbofuran on the grounds in the final rule cannot be raised again in any pumpkins. In response to the changes that aggregate exposure from all uses of subsequent proceedings on this rule. made on the labels, EPA revised its risk carbofuran fails to meet the FFDCA (73 FR at 44865). assessment to account for the reduced section 408 safety standard (Id). Based number of crops, the altered geographic on the contribution from food alone, D. Petitioners’ Comments on the restrictions, and the additional risk EPA calculated dietary exposures to Proposed Rule mitigation measures proposed as part of carbofuran exceed EPA’s level of The comment period for the proposed FMC’s comments. concern for all of the more sensitive rule closed on September 29, 2008. Having considered all comments subpopulations of infants and children. During the comment period, the received by the close of the comment At the 99.9th percentile, aggregate period, and based on its revised carbofuran dietary exposure from food Petitioners submitted comments and drinking water from contaminated challenging particular aspects of EPA’s analyses, EPA concluded that aggregate ground water was estimated to range risk assessment. For example, the exposures from all remaining uses of from 1100% of the aPAD for adults, to Petitioners challenged the basis for carbofuran were still unsafe for infants greater than 10,000% of the aPAD for EPA’s 4X children’s safety factor, and and children, and that revocation of the infants, the population subgroup with the method and assumptions on which remaining tolerances was warranted. the highest estimated dietary exposure EPA relied to estimate drinking water The final rule explained that, although (Ref. 12). Similarly, aggregate dietary concentrations. In addition, the the recent cancellation of several exposures from food and drinking water registrant, FMC Corporation, requested registered uses reduced the dietary risks from surface water, based on that EPA cancel the use on 22 of the to children, EPA’s analyses still showed contamination from use on corn in crops on which it was registered, that estimated exposures significantly including many of the foods posing the exceed EPA’s level of concern for 4 The draft NOIC was based on all of carbofuran’s highest risks to children. FMC also children. For example, EPA determined combined risks—dietary, occupational, and requested that EPA modify its labels to that the estimated risks could be as high ecological. Because some non-food use registrations include a number of additional as 9,400% of the aPAD for infants. A remain, EPA anticipates issuing the NOIC restrictions intended to mitigate the detailed description of the risk subsequent to undertaking the activities required to revoke the carbofuran tolerances to cancel these risks identified in EPA’s risk assessment supporting the final rule remaining uses. assessment. For example, use was follows.
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1. Toxicity. AChE inhibition in brain groups experience the highest levels of approach to comparing the relative and the PNS is the initial adverse dietary risk, protecting these groups sensitivity of brain and RBC AChE biological event which results from against the effects of carbofuran will, in inhibition would be to compare the exposure to carbofuran, and with turn, also protect other age groups. BMD10 estimates. However, BMD10 sufficient levels of inhibition leads to The Agency used a meta-analysis to estimates from the available RBC AChE other effects such as tremors, dizziness, calculate the BMD10 and BMDL10 for inhibition data are not reliable due to as well as gastrointestinal and pups and adults; this analysis includes lack of data at the low end of the dose cardiovascular effects, including brain data from studies where either response curve. As an alternative bradycardia (Ref. 15). Thus, AChE adult or juvenile rats or both were approach, EPA used the ratio of brain to inhibition provides the most exposed to a single oral dose of RBC AChE inhibition at the BMD50, appropriate effect to use in risk carbofuran. The Agency used a dose- since there are quality data at or near extrapolation for derivation of RfDs and time-response exponential model where the 50% response level such that a PADs. Protecting against AChE benchmark dose and half-life to reliable estimate can be calculated. EPA inhibition ensures that the other adverse recovery can be estimated together. This estimated the RBC BMD50 to brain effects associated with cholinergic model and the statistical approach to BMD50 potency ratio using EPA’s data toxicity, mentioned above, do not occur. deriving the BMD10 s, BMDL10 s, and for RBC (the only reliable RBC data in There are three studies available that half-life to recovery have been reviewed PND11 animals for carbofuran) and all compare the effects of carbofuran on and supported by the FIFRA SAP (Refs. available data in PND11 animals for eleven-day-old rats (i.e., post-natal day 34, 35, and 36). The meta-analysis brain. There is, however, an assumption 11 or PND11) rats with those in young approach offers the advantage over associated with using the 50% response adult rats (herein called comparative using single studies by combining level—namely that the magnitude of AChE studies) (Refs. 1, 2, 4, and 66). information across multiple studies and difference between RBC and brain AChE Two of these studies were submitted by thus provides a robust PoD. inhibition is constant across dose. In FMC, the registrant, and one was For AChE-inhibiting pesticides, EPA other words, EPA is assuming the RBC performed by EPA–ORD. An additional generally evaluates the effects of the and brain AChE dose response curves study conducted by EPA–ORD involved pesticide on both brain and RBC AChE. are parallel. There are currently no data PND17 rats (Ref. 63). Although it is not RBC AChE is used as a surrogate for to test this assumption for carbofuran. possible to directly correlate ages of effects on the PNS because data directly Comparing RBC BMD50 and brain juvenile rats to humans, PND11 rats are measuring effects on the PNS are BMD50 AChE inhibition, EPA calculated believed to be close in development to difficult to obtain. a BMD50 ratio of 4.1X. Accordingly, EPA newborn humans. PND17 rats are Using quality brain AChE data from concluded that a children’s safety factor believed to be closer developmentally to the three studies (two FMC, one EPA– of 4X would be protective of infants and human toddlers (Refs. 10, 22, and 23). ORD) conducted with PND11 rats, in children. Other studies in adult rats used in the combination, provides data to describe Using the BMDL10 of 0.03 mg/kg/day, Agency’s analysis included additional both low and high doses. By combining combined with the default 10X data from EPA–ORD (Refs. 54, 62, and the three studies in PND11 animals interspecies and intraspecies factors, 66). together in a meta-analysis, the entire along with the 4X children’s safety The studies in juvenile rats show a dose-response range is covered. The factor results in an aPAD = 0.000075 consistent pattern that juvenile rats are results of the BMD analysis for PND11 mg/kg/day for infants and children. The more sensitive than adult rats to the pup brain AChE data provide a BMD10 aPAD for youths and adults is effects of carbofuran. These effects of 0.04 mg/kg/day and BMDL10 of 0.03 calculated in the same manner, but EPA include inhibition in AChE in addition mg/kg/day—this BMDL10 of 0.03 mg/kg/ does not apply the 4X children’s safety to incidence of clinical signs of day provides the PoD (Ref. 70). factor, resulting in an aPAD of 0.0002 neurotoxicity such as tremors. This EPA, however, lacked adequate data mg/kg/day. pattern has also been observed for other on carbofuran’s effects on RBC AChE. 2. Acute Exposures from Food. The NMC pesticides, which exhibit the same Two studies required from FMC were estimated acute dietary exposure from mechanism of toxicity as carbofuran rejected as flawed. To account for the carbofuran residues in food alone (i.e., (Ref. 81). It is not unusual for juvenile lack of data in the PNS and/or a assuming no additional carbofuran rats, or indeed, for infants or young surrogate (i.e., RBC AChE inhibition exposure from drinking water), is below children, to be more sensitive to data) in pups at the low end of the EPA’s level of concern for the U.S. chemical exposures as metabolic response curve, and for the fact that Population and all population detoxification processes in the young RBC AChE inhibition appears to be a subgroups. Children 1 to 2 years of age are still developing. Because juvenile more sensitive point of departure (78% aPAD) were the most highly rats, called ‘pups’ herein, are more compared to brain AChE inhibition, exposed population subgroup when sensitive than adult rats, data from pups EPA determined that, consistent with food only was included. The major provide the most relevant information the statutory mandate, some portion of driver of the acute dietary exposure risk for evaluating risk to infants and young the statutory default 10X children’s (food only) for Children 1 to 2 years is children and are thus used to derive the safety factor needed to be retained. milk, at greater than 90% of the PoD. In addition, typically (and this is Because there are some carbofuran data exposure. the case for carbofuran) young children that characterize the toxicity in 3. Acute Exposures from Drinking (ages 0–5 years) tend to be the age juveniles, EPA concluded that the Water. EPA’s analyses show that those groups most exposed to carbofuran weight-of-the-evidence supports individuals-both adults as well as because they tend to ingest larger reducing the statutory factor of 10X to children—who receive their drinking amounts of food and water per their a value lower than 10X. This results in water from vulnerable sources are body weight than do teenagers or adults. a children’s safety factor that is less than exposed to levels that exceed EPA’s As such, the focus of EPA’s analysis of 10 but more than 1. level of concern—in some cases by carbofuran’s dietary risk from residues The modified children’s safety factor orders of magnitude. This primarily in food and water is on young children takes into account the greater sensitivity includes those populations consuming (ages 0 to 5 years). Since these age of the RBC AChE. The preferred drinking water from ground water from
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shallow wells in acidic aquifers overlaid from the aquifer, and the remaining two exposures ranged between 770% aPAD with sandy soils that have had crops values were chosen to reflect common for adults to 9400% aPAD for infants. treated with carbofuran. It could also pH values between the measured values. b. Surface Water. For the final rule, include those populations that obtain Based on EPA’s assessment, the EPA conducted additional refined their drinking water from reservoirs maximum 1-in-10-year peak carbofuran modeling based on the September 2008 located in small agricultural watersheds, concentrations in vulnerable ground label submitted by FMC. The modeling prone to runoff, and predominated by water for a single application on corn in addressed all of the domestic uses that crops that are treated with carbofuran, Wisconsin, at a rate of 1 pound per acre remain registered, and included certain although there is more uncertainty were estimated to range from a low of refinements to better understand the associated with these exposure less than 1 ppb based on a pH of 7 or impacts of varying pH. EPA also estimates. higher, to a high of 16 ppb, based on a conducted modeling to assess the a. Ground Water. In EPA’s revised pH of 6.5. impact of the proposed spray drift buffer assessment, ground water The results of EPA’s revised corn requirements and other spray drift concentrations were estimated for all modeling, based on a scenario in measures included on the September remaining crops on carbofuran labels, Wisconsin, are consistent with the label. and used two new Tier 2 scenarios. results of the PGW study developed by EPA estimated carbofuran Based on a new corn scenario, FMC in Maryland in the early 1980s. concentrations resulting from the use on representative of potentially vulnerable Using higher use rates than currently pumpkins by adjusting the estimated areas in the upper Midwest, EPA permitted, the peak concentration drinking water concentrations (EDWC) estimated 1-in-10-year concentrations measured in the PGW study was 65 ppb; from a previous run simulating melons for ground water source drinking water when scaled to current use rates, the in Missouri; adjustments accounted for × ¥3 μ of 16 to 1.6 10 g/L, for pH 6.5 and estimated peak concentration was 11 differences in application rate and row 7, respectively. A potato scenario ppb. EPA’s modeling is also consistent spacing. Two EDWCs were calculated representing use in the Northwest with a number of other targeted ground for pumpkins: One based on a 36-inch row spacing, representing pumpkins for estimated no measurable concentrations water studies conducted in the 1980s consumption (77.6 ppb); and a second of carbofuran in ground water. Other showing that high concentrations of based on a 60-inch row spacing, remaining uses were modeled using a carbofuran can occur in vulnerable representing decorative pumpkins (46.6 Tier 1 ground water model (Screening areas; the results of these studies as well Concentration in Groundwater) with ppb). as the PGW study are summarized in EPA had previously evaluated the estimated peak 90-day concentrations of References 13 and 67. 48–178 μg/L, depending on application corn rootworm rescue treatment at While there have been additional rate. Well setback prohibitions of 50 feet seven representative sites, representing ground water monitoring studies that were proposed on the September 2008 use in states with extensive carbofuran included carbofuran as an analyte since label for the flowable and granular usage at locations more vulnerable than that time, there has been no additional formulations in select counties in most in each state in areas corn is Kentucky (seven counties), Louisiana monitoring targeted to carbofuran use in grown. Using measured rainfall values, (one county), Minnesota (one county), areas where aquifers are vulnerable. and assuming typical rather than and Tennessee (one county). Analysis of However, data compiled in 2002 by maximum use rates, peak the impact of these setbacks for the use EPA’s Office of Water show that concentrations for the corn rescue on corn indicated that the setbacks carbofuran was detected in treated treatments simulated for Illinois, Iowa, would not reduce concentrations drinking water at a few locations. Based Indiana, Kansas, Minnesota, Nebraska, significantly at locations where on samples collected from 12,531 and Texas ranged from 16.6–36.7 ppb exposure to carbofuran in ground water ground water supplies in 16 states, (Ref. 47). Under the revised assessment is of concern because at acid pHs, carbofuran was found at one public to account for the September 2008 use carbofuran does not degrade sufficiently ground water system at a concentration restrictions, concentrations for corn, during the travel time from the of greater than 7 ppb and in two ground calculated including the proposed spray application site to the well to water systems at concentrations greater drift buffers in Kansas and Texas, substantially reduce the concentration. than 4 ppb (measurements below this decreased 5.1% and 4.7%, respectively, Exposure estimates for this limit were not reported). An infant from simulations with no buffer from assessment are drawn primarily from receiving these concentrations would the previous assessment (Ref. 47). In EPA’s modeling. To conduct its receive doses equivalent to 220% of the Kansas, the 1-in-10-year peak EDWCs modeling, EPA examined readily aPAD or 130% aPAD, respectively, decreased from 33.5 to 31.8 ppb when available data with respect to ground based on a single 8 ounce serving of a 300-foot buffer was added, and in water and soil pH to evaluate the spatial water. As this monitoring was not Texas, from 29.9 to 28.5 ppb with the variability of pH. Ground water pH targeted to carbofuran, the likelihood is addition of a 66-foot buffer. values can span a wide range; this is low that these samples capture peak For the sunflower use, 12 simulations especially true for shallow ground water concentrations. Given the lack of were performed for sunflowers, 9 in systems, where local conditions can targeted monitoring, EPA has primarily Kansas, and 3 in North Dakota. The greatly affect the quality and relied on modeling to develop estimates North Dakota scenario was used to characteristics of the water (higher or of carbofuran residues in ground water represent locations where sunflowers lower pHs compared to average values). sources of drinking water. are grown that are vulnerable to The ground water simulations reflect EPA compiled a distribution of pesticide movement to surface water variability in pH by modeling estimated carbofuran concentrations in while the Kansas scenario represents carbofuran leaching in four different pH water based on these estimates, which places that are not particularly conditions (pH 5.25, 6.5, 7.0, and 8.7), was used to generate probabilistic vulnerable, based on the limited rainfall representing the range in the Wisconsin assessments of the potential exposures and generally well-drained soils aquifer system. The upper and lower from drinking water derived from (hydrologic group B soils) that are found bound of pH values that EPA chose for vulnerable ground water sources. Based in that area. Estimated 1-in-10-year this assessment were measured values on these assessments, estimated concentrations ranged from 11.6 to 32.7
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μg/L. When simulating three throughout midwestern states to the distribution of values for the applications, one at plant and two foliar increase drainage in agricultural fields Nebraska corn rescue treatment was with a 14-day interval between the two (Ref. 13). Drains are common in the 22.3 ppb. Estimated dietary exposures foliar applications and a 66-foot buffer, upper Mississippi river basin (Illinois, based on these concentrations ratned the 1-in-10-year peak EDWC for North Iowa, and the southern part of from 340% of the aPAD for adults to Dakota was 22.4 μg/L. In contrast, the Minnesota), and the northern part of the 3900% of the aPAD for infants. More same three applications in Kansas with Ohio River Basin (Indiana, Ohio, and details on these assessments, as well as a 14-day interval between the foliar Michigan) (Ref. 58). Although it is not the assessments EPA conducted for applications and a 300-foot buffer possible to directly correlate the other crop scenarios, can be found in produced a 1-in-10-year peak EDWC of concentrations found in most of the References 12, 47, and 67. 20.5 μg/L. The 1-in-10-year peak studies with drinking water 4. Aggregate (food and water) EDWCs, assuming that carbofuran is concentrations, these studies confirm Exposures. EPA conducted a number of applied only at plant, were 14.0 and that carbofuran use under such probabilistic analyses to combine the 16.0 μg/L in Kansas and North Dakota circumstances can contaminate surface national food exposures with the respectively. EPA also evaluated the water, as tile drains have been identified exposures from the individual region impact of pH on carbofuran as a conduit to transport water and and crop-specific drinking water concentrations for sunflowers, resulting contaminants from the field to surface scenarios. Although food is distributed in a 10% decrease in 1-in-10-year peak waters. nationally, and residue values are therefore not expected to vary concentrations assuming high pH in the EPA conducted dietary exposure substantially throughout the country, reservoir. Spray drift buffers of 66 and analyses based on the modeling drinking water is locally derived and 300 feet decreased concentrations 4.7 scenarios for the proposed September consumed and concentrations of and 5.1% for corn and 10.0% and 2008 label. Exposures from all modeled pesticides in source water fluctuate over 16.0% for sunflowers, respectively, in scenarios substantially exceeded EPA’s time and location for a variety of comparison to previous labels that had level of concern (Ref. 12). For example, reasons. Consequently, EPA conducted no spray drift buffer requirements. a Kansas sunflower scenario, assuming several estimates of aggregate dietary Additional details on these assessments two foliar applications at a typical 1 lb can be found at Reference 84. risks by combining exposures from food active ingredient (a.i.) per acre use rate, These predicted carbofuran water and drinking water. These estimates applied at 14-day intervals, estimated a concentrations are similar or lower than showed that, because drinking water the peak concentrations reported in the 1-in-10-year peak carbofuran water exposures from any of the crops on the United States Geological Survey- concentration of 11.6 ppb. Exposures at label exceed safe levels, aggregate National Ambient Water Quality Survey the 99.9th percentile based on this exposures from food and water are (USGS–NAWQA) monitoring data. In modeled distribution ranged from 160% unsafe. Although EPA’s assessments addition, these data, which represent of the aPAD for youths 13 to 19 years, showed that, based on the Idaho potato concentrations in surface water prior to to greater than 2,000% of the aPAD for scenarios, exposures from ground water any treatment by a public drinking infants. This scenario is intended to be from use on potatoes would be safe, water system, are consistent with the representative of sites that are less surface water exposures from carbofuran results of the 2002 data on finished vulnerable than most on which use on potatoes far exceed the safety water compiled by EPA’s Office of sunflowers could be grown. By contrast, standard. More details on the individual Water. Based on samples collected from exposure estimates from a comparable aggregate assessments presented below, 1,394 surface water source drinking North Dakota sunflower scenario, as well as the assessments EPA water supplies in 16 states, carbofuran intended to represent more vulnerable conducted for other regional and crop was found at no public drinking water sites, estimated a 1-in-10-year peak scenarios, can be found in References 12 supply systems at concentrations concentration of 22.4 ppb. These and 13. exceeding maximum contaminant level concentrations would result in The results of aggregate exposures (MCL) of 40 ppb. However, carbofuran estimated exposures ranging between from food and from drinking water was found at one surface water public 450% aPAD for youths 13 to 19 years, derived from ground water in extremely water system in finished (i.e., post- to 5,500% aPAD for infants. Similarly, vulnerable areas (i.e., from shallow treatment) water at concentrations exposures based on a Washington wells associated with sandy soils and greater than 4 ppb (measurements below surface water potato scenario, and using acidic aquifers, such as are found in this limit were not reported). Sampling a 3 lb a.i. acre rate, ranged from 230% Wisconsin), ranged from 780% of the is costly and is conducted typically four of the aPAD for children 6 to 12 years aPAD for adults, to 9,400% of the aPAD times a year or less at any single to 890% of the aPAD for infants, with for infants. drinking water facility. The overall a 1-in-10-year peak carbofuran The results of aggregate exposure from likelihood of collecting samples that concentration of 7.2 ppb. Although food and water derived from one of the capture peak exposure events is, other crop scenarios resulted in higher least conservative surface water therefore, low. For chemicals with acute exposures, estimates for these two crops scenarios—Kansas sunflower, with two risks of concern, such as carbofuran, are presented here, as they are major foliar applications—ranged from 190% higher concentrations and resulting risk crops on which a large percentage of of the aPAD for adults to 2,100% aPAD is primarily associated with these peak carbofuran use occurs. For example, one for infants. These estimates reflect the events, which are not likely to be of EPA’s refined exposure analyses is risks only for those people in captured in monitoring unless the based on a Nebraska corn rootworm watersheds with characteristics similar sampling rate is very high. ‘‘rescue treatment’’ scenario, and to that used in the scenario, and There are few surface water field-scale assumes a single aerial application at a assuming that water treatment does not studies targeted to carbofuran use that typical rate of 1 lb a.i. per acre. The full remove carbofuran. The estimated water could be compared with modeling distribution of daily concentrations over concentrations are comparable to the results. Most of these studies were a 30-year period was used in the maximum peak concentrations reported conducted in fields that contain tile probabilistic dietary risk assessment. in monitoring studies that were not drains, which is a common practice The 1-in-10-year peak concentration of designed to detect peak, daily
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concentrations of carbofuran in the lowest exposure distributions, used for this person-day in the Total vulnerable locations. aggregate exposures at the 99.9th Daily Approach. More details on this assessment, as percentile ranged from 328% of the Peak inhibition occurs following each well as the assessments EPA conducted aPAD under the scenario for which occasion on which the infant consumed for other crop scenarios, can be found in infants rapidly metabolize carbofuran 8 fluid ounces of formula (6 a.m., 12 References 12, 47, and 67. For example, (e.g., 186 minute half-life), to a high of p.m., 4 p.m. and 8 p.m.); however, the in the proposed rule, EPA presented the 473% of the aPAD under the scenario maximum persisting dose occurs results from aggregate exposures for which infants metabolize carbofuran following the 9:30 p.m. eating occasion, resulting from a Nebraska surface water more slowly, (e.g., scenarios in which a based on a 186-minute half-life scenario based on a Nebraska corn 426 minute half life is assumed). parameter. This produces a maximum μ rootworm ‘‘rescue treatment.’’ Estimated Moreover, even accounting for the persisting dose of 0.1457 g ai/kg bw, or exposures from that scenario ranged estimated decreased risk from about 30% of the total daily exposure of μ from 330% of the aPAD for youths 13 accounting for carbofuran’s rapid 0.4158 g ai/kg bw derived above, or to 19 years to 3,900% of the aPAD for reversibility, the Agency remains expressed as a fraction of the level of infants. concerned about the risks from single concern, the maximum persisting dose As noted previously, EPA’s food and eating or drinking events, as illustrated amounts to about 194% of the aPAD (or water exposure assessments typically in the following example, based on an 30% of 554%). Note that with drinking sum exposures over a 24-hour period, actual food consumption diary from the water concentration at 4 ppb, an infant and EPA used this 24-hour total in CSFII survey. A 4-month old male non- consuming one 8 oz bottle of formula— developing its acute dietary risk nursing infant weighing 10 kg is prepared from powder and tap water assessment for carbofuran. Because of reported to have consumed a total of containing carbofuran at 4 ppb will the rapid nature of carbofuran toxicity 1,070 milliters (ml) of indirect water obtain exposures of approximately and recovery, EPA conducted an over eight different occasions during the 114% of aPAD. Since many infants analysis using information about dietary day. The first eating occasion occurred consume the equivalent of this amount exposure, timing of exposure within a at 6:30 a.m., when this 4 month old on a single eating occasion, accounting day, and half-life of AChE inhibition consumed 8 fluid ounces of formula for reversibility over multiple occasions from rats to estimate risk to carbofuran prepared from powder. The FCID food is not essential to ascertain that infants at durations less than 24 hours. recipes indicate that this particular food quite likely have obtained drinking Specifically, EPA has evaluated item consists of approximately 87.7% water exposures to carbofuran individual eating and drinking exceeding the level of concern based on water, and therefore, 8 ounces of occasions and used the AChE half-life to drinking water concentrations found in formula contains approximately 214 ml recovery information (herein called half- public drinking water supplies. life information) to estimate the residual (or grams) of indirect water; with the In this regard, it is important to note effects from carbofuran from previous powder (various nutrients, dairy, soy, EPA’s Eating Occasion Analyses exposures within the day. The oils, etc.) accounting for the remaining underestimate exposures to the extent carbofuran analyses are described in the 12.3%. This infant also reportedly that they do not take into account carry- 2009 aggregate (dietary) memo (Ref. 55). consumed a full 8-ounce bottle of over effects from previous days, and Using the two FMC time course formula at 12 p.m., 4 p.m., and 8 p.m. because drinking water pesticide studies in rat pups, EPA calculated half- that day. The food diary also indicates concentrations are randomly picked lives for recovery of 186 and 426 that the infant consumed about 1 from the entire 30-year distribution. As minutes (Refs. 24 and 25). The two tablespoon of water (14.8 ml) added to discussed previously, DEEM-FCID values provide an indication that half- prepare rice cereal at 10 a.m., about 2 [FN(TM)] is a single day dietary lives to recovery can vary among ounces of water (59.3 ml) added to pear exposure model, and the DEEM-based 1 juvenile rats. By extension, children are juice at 11 a.m., another ⁄2 tsp of water Eating Occasion Analysis accounts for expected to vary in their ability to (2.5 ml) to prepare more rice cereal at reversibility within each simulated recover from AChE inhibition where 8:30 p.m.; and finally, he consumed person-day. All of the empirical data longer recoveries would be associated another 4 ounces of formula (107 ml) at regarding time and amounts consumed with a potentially higher ‘‘persisting 9:30 p.m. (and corresponding exposures based on dose’’ (as described below). The infant’s total daily water intake the corresponding residues) from the This analysis had little impact on the (1,070 ml, or approximately 107 ml/kg/ CSFII survey are used, along with the exposures from food alone. However, day) is not overly conservative, and half-life to assess an equivalent accounting for drinking water represents substantially less than the persisting dose that produced the peak consumption throughout the day and 90th percentile value from CSFII on a inhibition expected over the course of using the half-life to recovery ml water/kg bodyweight (ml/kg/bw) that day. This is a reasonable information, risk is reduced by basis. As noted, carbofuran has been assumption for food alone; since the approximately 2–3X. Consequently, risk detected in finished water at time between exposure events across 2 estimates for which food and drinking concentrations of 4 ppb. For this 10 kg days is relatively high (compared to the water are jointly considered and body weight infant, an 8-ounce bottle of half-life)—most children (≤9 months) incorporated (i.e., Food + Drinking formula prepared from water containing tend to sleep through the night—and the Water) are also reduced considerably— carbofuran at 4 ppb leads to drinking time between dinner and breakfast the by a factor of two or more in some water exposures of 0.0856 micrograms following morning is long enough it is cases—compared to baseline. But even of active ingredient/kilogram of reasonable to ‘‘ignore’’ persisting effects though the risk estimates from aggregate bodyweight (μg ai/kg bw), or 114% of from the previous day. A single day exposure are reduced, they nonetheless the aPAD. Based on the total daily water exposure model will underestimate the still substantially exceed EPA’s level of intake of 1,070 ml/day (no reversibility), persisting effects from drinking water concern for infants and children. Using total daily exposures from water at 4 exposures (formula) among infants, and drinking water derived from the surface ppb concentration would amount to newborns in particular (<3 months), water from the Idaho potato surface 0.4158 μg ai/kg bw, or 555% of the since newborns tend to wake up every water scenario, which estimated one of aPAD; this is the amount that would be 2 to 4 hours to feed. Any carry over
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effects may be important, especially if that the cancellation of use on alfalfa values in a few exposures rather than exposures from the previous day are would reduce carbofuran residues in relatively lower values in a greater relatively high, since the time between milk by over 70%, even though many number of exposures. This is due to the the last feeding (formula) of the day and cows’ diet consists primarily of corn. fact that an acute assessment looks at a the first feeding of the subsequent day They assumed that residues would narrow window of exposure where there is short. A single day model also does decrease between 19% and 23% as a are unlikely to be a great variety of not account for the effect of seasonal result of the buffer requirements on the consumption sources. Thus, to the variations in drinking water September 2008 label, even though the extent that there is a high exposure it concentrations, which will make this label does not require the use of all of will be more likely due to a high residue effect more pronounced during the high the recommended ‘‘best management value in a single consumption event. use season (i.e., the time of year when practices’’ (e.g., no requirements Additionally worrisome in this regard is drinking water concentrations are high). regarding swath displacement), and that carbofuran is a highly potent (i.e., Based on these analyses, the Agency applicators do not universally use such has a very steep dose-response curve), concludes that the current exposure practices in the absence of any acute toxicant, and therefore any aPAD assessment methods used in the requirement. They assumed that average exceedances are more likely to have carbofuran dietary assessment provide ground water pH adequately greater significance in terms of the realistic and high confidence estimates characterizes the temporal and spatial potential likelihood of actual harm. For of risk to carbofuran exposure through heterogeneity common in most areas, all of these reasons, EPA determined food and water. despite the available evidence to the that the existing carbofuran tolerances contrary. Finally, they assumed that the F. Response to FMC Comments on the did not meet the FFDCA safety percent of the crop treated in any Final Rule standard, and should therefore be watershed would never exceed 5%, revoked. FMC’s comments raised a range of despite varying pest pressures, issues. Those issues are not summarized consultant recommendations, and VI. Response to Objections and here because FMC basically refilled individual grower decisions. Leaving Requests for Hearing many of its comments as objections aside that EPA believes most, if not all A. Overview without modifying them in response to of these assumptions are not supported Petitioners raised several objections EPA’s decision in the final rule. In by the available evidence described that correspond to four basic categories addition, FMA submitted a an alternate throughout the final rule, the probability of issues. The first category of objections risk analysis purporting to show that of all these assumptions always and hearing requests relates to aggregate carbofuran exposures to simultaneously holding true under real challenges to EPA’s selection of the children would be safe. However, FMC world conditions is unreasonably low, appropriate children’s safety factor. In failed to provide the data and details of and certainly does not approach the this category of issues, they raise that assessment to the Agency. They degree of certainty necessary for EPA to primarily two claims: (1) That EPA’s also failed to provide several critical conclude that children’s exposures will scientific basis for retaining a 4X safety components that served to support key be safe. inputs into that assessment; and for Determining whether residues will be factor is flawed, and (2) the statistical several of these, EPA was unable to safe for U.S. children is not a theoretical calculations supporting the 4X safety replicate the claimed results based on paper exercise; it cannot suffice to factor are flawed, and based on faulty the information contained in the hypothesize a unique set of assumptions. The second category of comments. In the absence of such circumstances that make residues ‘‘fit in issues relate to the manner in which critical components, the Agency was the box.’’ There must be a reasonable EPA conducted its assessment of the unable to accept the validity or utility certainty that under the variability that exposure from carbofuran through of the analyses, let alone rely on the exists under real world conditions, drinking water sources. In this regard, results. exposures will be ‘‘safe.’’ EPA’s all of their objections fall within three Nonetheless, based on the summary assessments incorporate a certain degree basic categories of issues: (1) EPA descriptions provided in the registrant’s of conservatism precisely to account for should have accounted for a more comments, EPA concluded that the risk the fact that assumptions must be made realistic percent of the crop treated analyses contained a critical flaw. The that may not prove accurate. This (PCT) in its surface water modeling; (2) commenters’ determination of safety consideration is highly relevant for EPA’s ground water concentration rests on the presumption that under real carbofuran, because as refined as EPA’s estimates are not based on the best world conditions, events will always assessments are, areas of uncertainty available data, but on obsolete data and occur exactly as hypothesized by the remain with regard to carbofuran’s risk overly conservative assumptions; and multiple assumptions in their potential. For example, a recent (3) FMC’s new label restrictions and assessment. For example, the comments epidemiological study reported that revised terms of registration will ensure assumed, despite all available evidence 45% of maternal and cord blood that drinking water concentrations will to the contrary, that children would not samples in a cohort of New York City not exceed 1.1 ppb. The third category be appreciably more sensitive to residents of Northern Manhattan and of issues relates to the manner in which carbofuran’s effects than adults. They the South Bronx between 2000 and EPA conducted its dietary risk assumed that carbofuran’s effects will be 2004, contained low, but measurable assessment. Under this category, the highly reversible, and that children will residues of carbofuran (Ref. 88). The objections and hearing requests raise be uniformly sensitive, such that the Agency is currently unable to account four primary issues: (1) Petitioners effects will be adequately accounted for for the source of such sustained challenge the way in which EPA’s risk by the assumption of a 150-minute half- exposures at this frequency. assessments accounted for individuals life, despite the fact that children are A further consideration is that the to recover from the effects of carbofuran not uniformly sensitive. They further risks of concern are acute risks to between exposures; (2) EPA should have assumed that there would be no carry children. For acute risks, the higher relied on the carbofuran human study over effect from the preceding day’s values in a probabilistic risk assessment and therefore use of the default 10X exposures for infants. They assumed are often driven by relatively high interspecies factor is inconsistent with
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the ‘‘best available data; (3) the import Petitioners’ claims do not present (1) A statement of the factual issues on tolerances by themselves are safe and genuine and substantial issues of fact which a hearing is requested and the EPA should have retained them even if and/or are immaterial to the relief requestor’s contentions on those issues; EPA believed tolerances associated with requested. (2) a copy of any report, article, or other the domestic uses were unsafe; and (4) On the merits, the majority of written document ‘‘upon which the Petitioners claim that the combined Petitioners’ objections are denied for objector relies to justify an evidentiary food and water exposures are safe, based substantially the same reasons given in hearing;’’ and (3) a summary of any on FMC’s drinking water estimates of a EPA’s final rule and response to other evidence relied upon to justify a 1.1 ppb maximum concentration, which comments. As noted, many of hearing. (40 CFR 178.27). are guaranteed by new label restrictions Petitioners’ objections are simply their The standard for granting a hearing submitted as part of objections. Finally, recycled comments which do not request is set forth in section 178.32. Petitioners raise one legal objection address the conclusions reached by EPA That section provides that a hearing will unaccompanied by a hearing request. in the final rule. To the extent a be granted if EPA determines that the They argue that EPA lacks authority to response is even needed to such a stale ‘‘material submitted’’ shows all of the limit issues and supporting information claim, it is provided in the final rule following: that can be raised in objections and and the response to comments. (1) There is a genuine and substantial issue hearing to those raised in earlier The remainder of this Unit is of fact for resolution at a hearing. An comments. organized in the following manner. Unit evidentiary hearing will not be granted on EPA denies each of the Petitioners’ VI.B describes in greater detail the issues of policy or law. objections as well as their hearing requirements pertaining to when it is (2) There is a reasonable possibility that requests. In the first instance, EPA appropriate to grant a hearing request. available evidence identified by the requestor denies Petitioners’ objections and their In Unit VI.C, EPA generally denies all of would, if established, resolve one or more of hearing requests because the objections Petitioners’ objections and hearing such issues in favor of the requestor, taking requests. Unit VI.D provides EPA’s into account uncontested claims or facts to are inextricably intertwined with the contrary. An evidentiary hearing will not proposed changes to carbofuran’s FIFRA response to the Petitioners legal be granted on the basis of mere allegations, registration that were not submitted objection that EPA lacks the legal denials, or general descriptions of positions until after publication of the final authority to limit the issues and and contentions, nor if the Administrator tolerance revocation rule. Objections to supporting information that can be concludes that the data and information EPA’s decision based on FIFRA raised in an objection and hearing to submitted, even if accurate, would be registration amendments proposed after those raised in comments on the insufficient to justify the factual EPA’s decision are irrelevant, and thus proposed rule. Units VI. G and I provide determination urged. Petitioners’ claims regarding EPA’s risk (3) Resolution of the factual issue(s) in the immaterial, to a challenge to EPA’s manner sought by the person requesting the decision (See Unit VI.C.). Secondly, an assessment. EPA’s conclusions on the hearing would be adequate to justify the individual analysis of Petitioners’ hearing requests and objections are action requested. An evidentiary hearing will objections and hearing requests leads to summarized in Unit VI.K. not be granted on factual issues that are not the same conclusion for the reasons EPA has adopted a 4-part format in determinative with respect to the action summarized below. Units VI.E through I. for explaining its requested. For example, a hearing will not be The Petitioners’ hearing requests fail ruling on each of the subissues EPA granted if the Administrator concludes that to meet the statutory and regulatory identified in the objections. First, the the action would be the same even if the requirements for holding a hearing. In Petitioners’ claim and any arguments or factual issue were resolved in the manner sought. most cases, EPA has denied the request evidence tendered to support that claim on the grounds that the objection is are described. Second, background (40 CFR 178.32(b)). irrelevant, and therefore immaterial, information on the claim is provided This provision essentially imposes with regard to EPA’s final tolerance including whether and how the claim four requirements upon a hearing revocation regulation. In particular, was presented in Petitioners’ comments requestor. First, the requestor must many claims are immaterial because and, if it was presented, EPA’s reasons show it is raising a question of fact, not they largely restate the claims in their for denying the claim in its final rule one of law or policy. Hearings are for combined comments on EPA’s proposed and response to comments. Third, EPA resolving factual issues, not for debating rule without challenging the substance explains its reasons for denying a law or policy questions. Second, the or even responding to EPA’s hearing on that claim. Finally, EPA requestor must demonstrate that there is explanations for the reasons that EPA explains its reasons for denying the a genuine dispute as to the issue of fact. declined to adopt the approaches or claim on the merits. If the facts are undisputed or the record otherwise make the revisions suggested is clear that no genuine dispute exists, by the Petitioners in their comments. B. The Standard for Granting an there is no need for a hearing. Third, the These claims are irrelevant to the Evidentiary Hearing requestor must show that the disputed determinations reached in the final rule. EPA has established regulations factual question is material—i.e., that it In several instances, EPA concluded governing objections to tolerance is outcome determinative with regard to that Petitioners evidentiary proffer was rulemakings and tolerance petition the relief requested in the objections. inadequate, because the data and denials and requests for hearings on Finally, the requestor must make a information submitted, even if accurate, those objections. (40 CFR Part 178; 55 sufficient evidentiary proffer to would be insufficient to justify the FR 50291 (December 5, 1990)). Those demonstrate that there is a reasonable factual determination urged, or to regulations prescribe both the form and possibility that the issue could be resolve one or more of the issues in their content of hearing requests and the resolved in favor of the requestor. favor. Further, in many cases, the standard under which EPA is to Hearings are for the purpose of evidence submitted constituted mere evaluate requests for an evidentiary providing objectors with an opportunity allegations and general denials and hearing. to present evidence supporting their contentions, which EPA regulations As to the form and content of a objections as the regulation states, expressly provide to be insufficient to hearing request, the regulations specify hearings will not be granted on the basis justify a hearing. In addition, many of that a hearing request must include: of ‘‘mere allegations, denials, or general
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descriptions of positions or if and to the extent the Administrator specific regulatory decision. In no sense, contentions.’’ (40 CFR 178.32(b)(2)). determines that such a public hearing is however, can it be claimed that EPA EPA’s hearing request requirements necessary to receive factual evidence erred, or that there is something are based heavily on FDA regulations relevant to material issues of fact raised objectionable, in its May 15, 2009 file establishing similar requirements for by the objections’’ (21 U.S.C. rule because EPA did not consider a hearing requests filed under other 346a(g)(2)(B)). This language grants EPA proposed revision to the terms of the provisions of the FFDCA (53 FR 41126, broad discretion to determine whether a carbofuran registration that had not yet 41129 (October 19, 1988)). FDA hearing is ‘‘necessary to receive factual been made. EPA need not shoot at a pioneered the use of summary evidence’’ to objections (H.R. Rep. No. moving target, much less a target that is judgment-type procedures to limit 104–669, at 49 (1996)). not in existence. Therefore, Petitioners’ hearings to disputed material factual objections are irrelevant, and thus C. General Denial of Objections and issues and thereby conserve agency immaterial, to the May 15, 2009 final Hearing Requests resources. FDA’s use of such procedures rule; they are based on hypothetical was upheld by the Supreme Court in Petitioners’ objections and hearing terms of carbofuran use not before the 1972, (Weinberger v. Hynson, Westcott requests are denied in their entirety as Agency as it made its determination in & Dunning, Inc., 412 U.S. 609 (1973)), irrelevant, and therefore immaterial, to that final rule. and, in 1975, FDA promulgated generic EPA’s determination in the May 15, Moreover, it is not as if Petitioners’ regulations establishing the standard for 2009 final rule that the carbofuran proposed terms for carbofuran use are evaluating hearing requests (40 FR tolerances were unsafe and could not be simple, straightforward use deletions 22950 (May 27, 1975)). It is these sustained under FFDCA section 408. In that could be immediately effectuated. regulations upon which EPA relied in that final rule, EPA assessed the risks While such a proposal is still irrelevant promulgating its hearing regulations in from carbofuran based on existing uses as a challenge to a prior EPA 1990. of carbofuran, as modified by all use determination, such a proposal might Unlike EPA, FDA has had numerous restrictions proposed by FMC. EPA lead EPA to expeditiously modify its occasions to apply its regulations on concluded that the carbofuran action. Rather, Petitioners have hearing requests. FDA’s summary of the tolerances substantially exceeded the proposed an unprecedented scheme thrust of its regulations, which has been FFDCA safety standard, particularly as involving FMC playing a role as a repeatedly published in the Federal to infants and children. middleman between EPA and growers Register in orders ruling on hearing Petitioners’ objections and hearing to ensure that carbofuran use in no one requests over the last 24 years, is requests as to that final rule disclose on area exceeds a certain percentage of the instructive on the proper interpretation their face their irrelevance to the cropped area. FMC has properly filed of the regulatory requirements. That conclusions reached in the May 15, proposed amendments to its FIFRA summary states: 2009 final rule. As Petitioners registration, which would incorporate summarize their objections on the first these new restrictions on carbofuran use A party seeking a hearing is required to page of their submission: and EPA will review these proposals meet a threshold burden of tendering evidence suggesting the need for a hearing.’ Petitioners disagree that the carbofuran consistent with the substantive and [] An allegation that a hearing is necessary to tolerances are unsafe and argue that the procedural requirements of FIFRA. At sharpen the issues’ or fully develop the facts’ available scientific data show that there is a such time as these new terms of does not meet this test. If a hearing request reasonable certainty of no harm to human registration are determined by EPA to fails to identify any evidence that would be health from the continued use of carbofuran meet the standard for registration, and the subject of a hearing, there is no point in for certain specific uses and related not before, would it be appropriate for holding one. tolerances under the terms for reregistration EPA to consider whether the tolerance proposed by Petitioners. A hearing request must not only contain revoked by the May 15, 2009 rule evidence, but that evidence should raise a (Objections at 1) (footnote omitted) should be re-established. material issue of fact concerning which a (emphasis added). As Petitioners’ Finally, Petitioners argue that it can meaningful hearing might be held. [] FDA footnote to this sentence reveals, raise its proposed terms of carbofuran need not grant a hearing in each case where however, the proposed terms for FIFRA an objection submits additional information use because EPA cannot limit them from or posits a novel interpretation of existing reregistration referenced by Petitioners putting forward new issues in a hearing. information. [] Stated another way, a hearing include significant terms submitted to As explained below, EPA believes is justified only if the objections are made in EPA on June 29, 2009, 44 days after Petitioners have misconstrued the law good faith and if they ‘‘draw in question in publication of the final rule revoking on this point. However, even assuming a material way the underpinnings of the carbofuran’s FFDCA tolerances. In fact, for the sake of argument that Petitioners regulation at issue.’’ Finally, courts have the body of Petitioners’ objections show are correct that new issues can be raised uniformly recognized that a hearing need not that FMC’s June 29, 2009 proposed at a hearing on objections, Petitioners be held to resolve questions of law or policy FIFRA registration amendments are admit that any newly raised issues must (49 FR 6672, 6673 (February 22, inextricably intertwined with the claims meet the standard of relevance. As 1984); 72 FR 39557, 39558 (July 19, made in the objections. Thus, explained above, however, objections 2007) (citations omitted)). Petitioners are actually not objecting to based on terms or FIFRA registration EPA has been guided by FDA’s the conclusions in EPA’s final rule; proposed after EPA’s final rule are application of its regulations in this rather, they are suggesting that EPA irrelevant to the correctness of EPA’s proceeding. Congress confirmed EPA’s might reach a different result in a determination in that final rule. authority to use summary judgment- different factual scenario. EPA has nonetheless evaluated each type procedures with hearing requests Objections, however, must be directed of Petitioners’ objections and hearing when it amended FFDCA section 408 in ‘‘with particularity [at] the provisions of requests and determined that there are 1996. Although the statute had been the regulation or order deemed alternate grounds for denying them. (See silent on this issue previously, the objectionable.’’ 21 U.S.C. 346a(g)(2). The Units VI.E through I). EPA has FQPA added language specifying that key here is that a party must file undertaken this analysis for all of the when a hearing is requested, EPA ‘‘shall particularized objections to—that is, objections despite the fact that it is not * * * hold a public evidentiary hearing identify some type of error in—a at all clear that those of Petitioners’
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claims which appear to be unrelated to discussed at length in the Final Rule, considered that the usual requirements FMC’s recently proposed registration the provisions of 408(g) are not to be applicable to informal rulemakings amendments would either individually viewed in isolation, but as part of a would remain applicable in this or collectively change EPA’s safety coherent statutory structure inextricably informal rulemaking. The proposal determination for the carbofuran linked to the FFDCA’s informal explicitly noted that ‘‘[i]f you anticipate tolerances given the relatively high level rulemaking procedures and section 553 that you may wish to file objections on of risk estimated for the carbofuran of the APA. Petitioners concede that the final rule, you must raise those tolerances in the final revocation rule. FFDCA section 408 establishes an issues in your comments on this Petitioners have certainly not provided informal rulemaking process (Obj at 62– proposal. EPA will treat as waived, any any road map as to how a safety finding 63). As an informal rulemaking, the issue not originally raised in comments could be made absent FMC’s recently- process is governed by section 553 of on this proposal’’ (73 FR 44,865 (July proposed registration amendments. The the APA and the case law interpreting 31, 2008)). failure to make such a showing is these requirements, except to the extent The fact that FFDCA section 408 in further justification for EPA’s denial of that section 408 provides otherwise.5 In certain limited circumstances Petitioners’ objections and hearing this regard, it is well established that the supplements the informal rulemaking requests. failure to raise factual or legal issues with a hearing does not fundamentally during the comment period of a alter the requirements applicable to D. Response to Petitioners’ Objection informal rulemakings. Nor, as discussed That EPA Lacks the Authority To Limit rulemaking constitutes waiver of the issues in further proceedings. E.g., below, does it convert this into a formal the Issues That May Be Raised in rulemaking, subject to the exception in Objections and Hearing Requests Forest Guardians v. U.S. Forest Service, 495 F.3d 1162, 1170–1172 (10th Cir. section 553. The FFDCA section 408 1. Response to Legal Issue. Petitioners 2007) (Claim held waived where establishes a unique statutory structure claim that EPA lacks the authority to commenters ‘‘failed to present its claims with multiple procedural stages, and restrict the issues that may be raised as in sufficient detail to allow the agency delegates to EPA the discretion to part of their objections. Specifically, to rectify the alleged violation’’); determine the implementation that best they challenge EPA’s interpretation that Nuclear Energy Institute v. EPA, 373 achieves the statutory objectives. the failure to raise issues or provide F.3d 1251, 1290–1291 (DC Cir. 2004) Accordingly, EPA interprets the notice information during the comment period (‘‘To preserve a legal or factual and comment rulemaking portion of the on the proposed rule bars consideration argument, we require its proponent to FFDCA section 408 process as an of such issues or evidence as part of have given the agency a ‘fair integral part of the FFDCA process, submitted objections or hearings. opportunity’ to entertain it in the inextricably linked to the administrative Petitioners make two arguments in administrative forum before raising it in hearing. The point of the rulemaking is support of this contention: (1) That the judicial forum.’’) Native Ecosystems to resolve the issues that can be neither FFDCA section 408(g) on its face Council v. Dombeck, 304 F.3d 886, 889– resolved, and to identify and narrow nor EPA’s regulations implementing 900 (9th Cir. 2002) (Purpose of any remaining issues for adjudication. FFDCA section 408(g) limit the issues requirement that issues not presented at Consequently the administrative hearing that can be raised in objections, or in administrative level are deemed waived does not represent an unlimited any hearing; and (2) that even though is to avoid premature claims and ensure opportunity to supplement the record, the rulemaking phase is governed by that agency be given a chance to bring particularly with information that was 553 of the Administrative Procedure Act its expertise to bear to resolve a claim); available during the comment period, (APA), the hearing must be held in Kleissler v. U.S. Forest Service, 183 F.3d but that commenters have chosen to accordance with APA sections 556 and 196, 202 (3d Cir. 1999) (Policy withhold. For example, as discussed at 557, which requires that the ‘‘exclusive underlying exhaustion requirement is greater length in Unit VI.E.2, both in record for decision must consist of that ‘‘objections and issues should first their comments, and again in their testimony and exhibits received at the be reviewed by those with expertise in objections, the Petitioners failed to hearing, as well as other papers filed in provide the underlying mathematical the contested subject area’’); National the hearing proceeding’’ (Obj at 64). On modeling that supported their claim that Association of Manufacturers v. U.S. this basis, the Petitioners conclude that the appropriate children’s safety factor DOI, 134 F.3d 1095, 1111 (DC Cir. 1998) all of the cases cited in the Final Rule was 1X, rather than 4X. Instead, they (‘‘We decline to find that scattered requiring parties to raise all issues and presented only summary results. references to the services concept in a information on which they intend to Similarly, although the Petitioners voluminous record addressing myriad rely in subsequent proceedings are claimed in their comments to have complex technical and policy matters inapplicable. conducted an alternate analysis showing suffices to provide an agency like DOI These arguments are premised on that aggregate carbofuran exposures to with a ‘fair opportunity’ to pass on the several fundamental misconstructions of children would be safe, they failed to the FFDCA section 408 and the APA. issue’’); Linemaster Switch Corporation provide the data and details of that None of the cases they cite address the v. EPA, 938 F.2d 1299, 1305–1306 (DC assessment to the Agency. They also specific question of whether and how Cir. 1991) (declining to consider in failed to provide several critical the requirements of section 553 of the challenge to final rule, data alluded to components that served to support key APA apply to FFDCA section 408. And in comments but not submitted during inputs into that assessment. for many of these cases, Petitioners the comment period, and information To read the statute otherwise would misquote the cases, misinterpret the submitted to EPA office that was not be to render the rulemaking portion of holdings, or misconstrue language taken developing the rule). the process entirely duplicative of the out of context. Moreover, EPA clearly stated in the hearing, and thus, ultimately Petitioners’ first argument, that proposed rule that the Agency meaningless. See, e.g., FDA v. Brown & neither section 408(g) nor EPA’s Williamson Tobacco, 529 U.S. 120, 132– 5 For example, section 408(d) allows the Agency regulations limit the issues that can be to proceed to a final rule after publication of a 133 (2000) (Court must interpret statute raised in objections or in any hearing, is submitted petition, rather than requiring as a symmetrical and coherent incorrect and misses the point. As publication of a proposal. regulatory scheme, and fit, if possible,
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all parts into a harmonious whole.) any and all objections; rather it means because they had failed in their original APW, AFL–CIO v. Potter, 343 F.3d 619, that Congress left the question of what petition to raise the claim asserted in 626 (2nd Cir. 2003) (‘‘A basic tenet of constitutes ‘‘reasonable grounds’’ for their objection (73 FR 42683, 42696 statutory construction * * * [is] that a EPA to resolve. (July 23, 2008)). EPA noted that text should be construed so that effect In construing that requirement, EPA although NRDC did argue in its petition is given to all its provisions, so that no gives weight to the fact that 408(g) is that EPA cannot make a safety finding part will be inoperative or superfluous, only one part of a larger, multi-stage, without completing the endocrine void or insignificant, and so that one administrative process, and that the screening program under FFDCA section will not destroy another statute does not support an section 408(p), it did not assert claims * * *’’), quoting Silverman v. Eastrich interpretation that this one phase be regarding the endocrine data and the Mulitple Investor Fund, 51 F.3d 28, 31 granted greater significance than the rest children’s safety factor. Citing its (3rd Cir. 1995). The equities of this of the process. Also relevant is that previous decision, EPA denied NRDC’s construction are particularly strong, Congress delegated broad discretion to objections and hearing requests as to the where, as here, the information was (or the Agency to determine whether a children’s safety factor (Id.). In that should have been) available during the hearing is ‘‘necessary’’ (21 U.S.C. same decision, EPA also denied a comment period. See, Kleissler, 183 346a(g)(2)(B)). Accordingly, EPA number of hearing requests on the F.3d at 202 (‘‘[A]dministrative believes that whether an objection states ground that requestor failed to proffer proceedings should not be a game or a ‘‘reasonable grounds’’ is to be measured supporting evidence; EPA opined that a forum to engage in unjustified against the context of the rulemaking, failure to offer evidence at an earlier obstructionism by making cryptic and and the provisions applicable to hearing stage of the administrative proceeding obscure reference to matters that ‘ought requests. could not be cured by suddenly to be’ considered and then, after failing Fundamentally, FFDCA section 408 submitting such evidence with a hearing to do more to bring the matter to the delegates broad discretion to EPA, both request. (See 73 FR 42683, 42710 (July agency’s attention, seeking to have that to determine how best to harmonize the 23, 2008) (‘‘Presumably Congress agency determination vacated’’) citing statutory process and to determine what created a multi-stage administrative Vermont Yankee Nuclear Power Corp. v. constitutes ‘‘reasonable grounds’’ for process for resolution of tolerance NRDC, 435 U.S. 519, 553–54 (1978). For objections. Consequently, the relevant petitions to give EPA the opportunity in example, one of Petitioners’ exhibits is question is whether EPA’s exercise of the first stage of the proceedings to the drinking water modeling that served discretion in requiring parties to present resolve factual issues, where possible, as the basis for the comments submitted all available factual issues and evidence through a notice-and-comment process, on the proposed rule. The documents during the rulemaking is reasonable. It prior to requiring EPA to hold a full is undeniably a reasonable exercise of are dated well before the close of the evidentiary hearing, which can involve discretion to ensure that the rulemaking comment period, and were clearly a substantial investment of resources by is not an opportunity for one party to available for submission along with the all parties taking part * * * waste the time and resources of all comments (Exhibit 15). Yet they were Accordingly, if a party were to withhold parties—both the government and other only provided to EPA as part of the evidence from the first stage of a rulemaking participants—by failing to Petitioners’ objections. tolerance petition proceeding and only raise all of their issues or withholding produce it as part of a request for a Contrary to Petitioners’ contention, information for the purpose of hearing on an objection, EPA might very EPA’s interpretation is entirely surprising the government at a later likely determine that such an untimely consistent with the FFDCA’s language point during the proceeding. See, e.g., submission of supporting evidence and structure. The fact that the statute Vt. Yankee, 435 U.S. at 553–554; United and regulations allow ‘‘any person’’ to States v. L.A. Tucker Truck Lines, 344 constituted an amendment to the file objections is immaterial. At issue is U.S. 33, 37 (1952) (‘‘courts should not Original petition requiring a return to not ‘‘who’’ may raise objections, but topple over administrative decisions the first stage of the administrative what issues may be raised as part of the unless the administrative body * * * proceeding (if, consideration of objections to justify a hearing. And on has erred against objection made at the information that was previously the relevant question, the statute is clear time appropriate under its practice’’). available is appropriate at all’’). that only certain issues—those of EPA has consistently interpreted The two cases Petitioners cite that are material fact—may be raised in section 408 in this fashion since the specific to section 408(d) do not alter objections to justify a hearing (21 U.S.C. 1996 amendments. For example, EPA this assessment. Neither of those cases 346a(g)(2)(B)). EPA’s regulations expand previously ruled that a petitioner could addressed the scope of the evidence that on this limitation, providing, among not raise new issues in filing objections could be properly raised as part of other requirements, that hearings will to EPA’s denial of its Original petition. objections to justify a hearing. Nor were not be held on legal or policy issues, nor See 72 FR 39318, 39324 (July 18, 2007) the courts examining the extent of EPA’s on the basis of mere allegations, nor (‘‘The FFDCA’s tolerance revocation authority to impose requirements on the where EPA concludes that the data and procedures are not some sort of ‘game,’ filing of objections under 408(g). Rather information submitted, even if accurate, whereby a party may petition to revoke these courts were evaluating the scope would be insufficient to justify the a tolerance on one ground, and then, of the FFDCA’s exclusive review factual determination urged (See 40 CFR after the petition is denied, file provisions, and whether the plaintiffs 178.32). It is true that FFDCA section objections to the denial based on an could bring a challenge to EPA policies 408(g)(2)(A) provides little guidance on entirely new ground not relied upon by and individual tolerance decisions the objections that a party may raise, EPA in denying the petition.’’). EPA without first exhausting the FFDCA’s requiring only that parties identify the reasoned that new issues were not petition process. Geertson Farms v. specific provisions challenged, and state cognizable because they ‘‘not an Johanns, 439 F.Supp.2d 1012, 1022– ‘‘reasonable grounds’’ for their objection to the ‘provisions of the * * * 1023 (N.D. Ca 2006); NY v. EPA, 350 objection. But the relative silence of the order [denying the petition]’ ’’ (Id.). F.Supp.2d 429, 442–443 (S.D.N.Y. statutory provision does not mean that Similarly, in a recent decision EPA 2004). This issue is not identical to the EPA is required to allow parties to raise denied NRDC’s request for a hearing questions at issue here: for example, the
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court in Geertson Farms held that the process (74 FR 23070 (May 15, 2009)); 346a(g)(2)(B), 346a(g)(2)(C). See also, plaintiffs’ procedural and policy Obj at 62). Hybrid rulemaking is not H.R. Rep. No. 104–669, at 49 (1996). decisions were properly raised initially formal rulemaking, which is the only The Supreme Court made clear in before the Agency through the petition rulemaking to which APA sections 556 Florida East Coast Railway v. FLRA, that process. 439 F.Supp2d at 442. Yet it is and 557 apply. Nevertheless, Petitioners the circumstances under which rules are undeniable that EPA’s regulations contend that once objections are raised, ‘‘required to be made on the record after preclude the reliance on policy or legal ‘‘Congress required the use of a formal opportunity for an agency hearing’’ are issues as a justification for an Agency rulemaking procedure involving an on- limited to those where Congress clearly hearing. the-record hearing for resolving factual indicates the intent to do so. 410 US Nor do the Petitioners’ other cases disputes.’’ (Obj at 62) Nothing in the 224, 241 (1973). The mere fact that compel a different result. The majority FFDCA section 408 or the APA supports statute offers an opportunity for an of the Petitioners’ cases concern FFDCA this interpretation. And the cases cited agency hearing is not sufficient to bring section 701(e), which differs in several in support of this argument are rulemaking under scope of this significant respects from FFDCA section inapposite or misconstrued. exemption. Id. See also, U.S. v. 408. Section 701(e) imposes no The APA section 553 on its face Allegheny-Ludlum Steel, 406 U.S. 742 requirements whatsoever on the party applies to all rulemakings except (1972); NRA v. Brady, 914 F.2d 475, 485 submitting the objection: ‘‘any person ‘‘[w]hen rules are required by statute to (9th Cir. 1990) (No oral hearing required may file objections * * * specifying the be made on the record after opportunity where statute required Secretary to ‘‘afford interested parties opportunity provisions of the order deemed for an agency hearing’’ (5 U.S.C. 553(c)). objectionable, stating the grounds for hearing’’ and Agency regulations Under this language, APA section 553 therefore * * *’’ 21 U.S.C. 371(e)(2). reserved right to determine whether oral will apply unless two requirements are This section also expressly provides that hearing warranted); Wisconsin Gas Co v. met: (1) The statute requires an FDA must hold a hearing upon request: FERC, 770 F.2d 1144, 1165–1168 (DC opportunity for a hearing as part of the ‘‘As soon as practicable after such Cir. 1985) (APA 556 hearing not rulemaking, and (2) the hearing is request for a public hearing, the required when statute only contained required to be ‘‘on the record.’’ FFDCA Secretary, after due notice, shall hold provisions requiring decision ‘‘after a section 408 hearings are neither such a public hearing for the purpose of hearing’’ and ‘‘substantial evidence’’ ‘‘required,’’ nor mandated to be ‘‘on the receiving evidence relevant and material standard of judicial review); AT&T v. record.’’ The case law is clear that to the issues raised by such objections.’’ FCC, 572 F.2d 17, 21–23 (2d Cir. 1978) 21 U.S.C. 371(e)(3). In the face of this statutes containing both characteristics (APA 556 hearing not required when language, it is unsurprising that the are the hallmark of formal rulemaking, statute only contained provisions courts held that FDA lacked discretion and that formal rulemaking is the rare requiring decision ‘‘after a hearing’’ and to deny a hearing. Further, under exception. AT&T v. FCC, 572 F.2d 17, ‘‘substantial evidence’’ standard of FFDCA section 701(e) the mere filing of 21–23 (2d Cir. 1978) (‘‘The APA judicial review) Philips Petroleum Co v. an objection automatically stays the requires trial-type hearings only ‘[w]hen FPC, 475 F.2d 842, 851–852 (10th Cir. effectiveness of the challenged rules (or adjudications) are required by 1973) (formal rulemaking not required provisions. ‘‘Until final action is taken statute to be made (or determined) on even though statute required ‘‘full upon such objections is taken by the the record after opportunity for an hearing’’ and Agency traditionally Secretary under paragraph (3), the filing agency hearing.’ ’’) (citations omitted); conducted trial-type adjudicative of such objections shall operate to stay Minden Beef Co v. Cost of Living hearing). the effectiveness of those provisions of Council, 362 F.Supp. 298 (D. Neb. 1973) Unless the statute providing for the order to which the objections are (examining whether statutory provision agency action prescribes ‘‘hearings on made.’’ 21 U.S.C. 371(e)(3). By contrast, that ‘‘[t]o the maximum extent possible, the record,’’ either in those exact words section 408 grants the Administrator the the President or his delegate shall or by using similar words to indicate discretion to stay the effectiveness of the conduct formal hearings * * *’’ makes that Congress specifically intended to regulation if objections are filed. 21 hearings mandatory, in determinating impose the full trial-type requirements U.S.C. 346a(g)(1). Indeed, the whether formal rulemaking required). of sections 556 and 557, the statute does Petitioners’ own cases specifically See also, e.g., Girard v. Klopfenstien, not fall within section 553’s exception. distinguish between section 701(e) and 930 F.2d 738, 741 (9th Cir. 1991) (‘‘The FL East Coast Railway, 410 US at 241. other FFDCA provisions. See Pactra APA does not apply because a While the absence of those words is not Industries v. Consumer Product Safety debarment hearing is not required by dispositive, ‘‘in the absence of these Commission, 555 F.2d 677, 685 (9th Cir. statute. The fact that the hearing is ‘on magic words, Congress must clearly 1977) (rejecting FDA argument that the record’ does not trigger an indicate its intent to trigger the formal, FFDCA section 701 should be read application of the formal adjudication on the record hearing provisions of the consistently with FFDCA sections 505 provisions of section 554 of the APA’’); APA.’’ City of West Chicago, Illinois v. and 507 to allow for summary judgment Smedberg Machine & Tool v. Donovan, NRC. 701 F.2d 632, 641 (7th Cir. 1983) procedures). 730 F.2d 1089, 1092–93 (7th Cir. 1984) (citations omitted). See also, e.g., Petitioners’ second argument is (holding section 554 inapplicable to a National Classification Committee v. equally incorrect.6 As an initial matter, proceeding that ‘‘gives the ICC. 765 F.2d 1146, 1150–1151 (DC Cir. the parties agree that FFDCA 408 adminsitrative law judge the discretion, 1985) (‘‘Thus under Florida East Coast, establishes a hybrid rulemaking rather than the obligation to conduct a there is a strong presumption that the procedure, with informal rulemaking review hearing.’’). As discussed below, procedural guarantees of section 553 of initiating, and frequently ending, the in contrast to other sections of the the APA are sufficient unless Congress FFDCA, such as section 701(e), FFDCA specifically indicates to the contrary’’ 6 As discussed below, it is not clear that a section 408 makes clear that a hearing citing Vermont Yankee Nuclear Power determination that a hearing, if held, must be held is not mandatory upon request, but that Corp v. NRC, 435 U.S. 519 (1978)); AT in accordance with APA sections 556 and 557 precludes EPA from exercising its discretion to EPA has broad discretion to determine & T v. FCC, 572 F.2d at 21–23 (‘‘The restrict the issues and evidence that may be raised whether a public hearing is necessary to words, ‘on the record’ have become, as at this final stage of the administrative process. receive factual evidence. See, 21 U.S.C. the District of Columbia Circuit has
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observed, a ‘touchstone test’ for the shall be made part of the record of the purposely in the disparate inclusion or applicability of the APA’s trial-type hearing, if relevant and material, subject exclusion’’). procedures’’); Philips Petroleum Co, 475 to the provisions of section [556] of the Equally significant is that the F.2d at 851–852 (‘‘The fact, as APA.’’). 21 U.S.C. 346(d)(5). Moreover, language of section 408 explicitly grants previously noted, that the Gas Act does the previous version of the statute EPA broad discretion to deny a hearing. not contain the words ‘on the record’ contained additional language Section 408(g)(2)(B) provides that EPA furnishes a strong argument in support consistent with the requirement of shall ‘‘hold a public evidentiary hearing, of the Commission’s contention that hearings subject to APA sections 556 if and to the extent the Administrator informal rulemaking satisfies the and 557; for example, the previous determines that such a public hearing is requirements of the APA’’); Minden Beef version of section 408(d)(5) repeatedly necessary to receive factual evidence Co, 362 F.Supp. at 306–307 (‘‘Requiring makes reference to ‘‘testifying at such relevant to material issues of fact raised ‘formal hearings’ is not identical with hearing.’’ A further consideration is that by the objections’’ (21 U.S.C. requiring that rules be made on the several other provisions of the FFDCA 346a(g)(2)(B)) (emphasis added). This record after opportunity for agency do explicitly reference APA sections language grants EPA the discretion to hearing.’’) What is notable is that, in all 554 or 556. Compare, 21 U.S.C. determine whether the issues raised in cases, the court required clear 333(g)(3) (‘‘A civil penalty * * * shall objections are ‘‘material’’ issues of fact. expression that Congress specifically be assessed by the Secretary by an order Further, even where evidence relevant intended to impose full trial-type made on the record after opportunity for to an issue of material fact is proffered requirements. a hearing provided in accordance with (essentially the standard set forth in 40 Thus the question is whether this subparagraph and section 554 of CFR 178.32), EPA construes the Congress indicated any intent to entirely title 5’’); 21 U.S.C. 342(f)(1)(C) statutory language as requiring it to hold remove the FFDCA section 408 process (requiring the Secretary, upon any a hearing only where it determines it is from the requirements of 553. The mere declaration of imminent hazard under necessary to receive proffered evidence. fact that FFDCA section 408 requires this section to ‘‘initiate a proceeding in In other words, the statute grants EPA some (or even many) of the procedures accordance with sections 554 and 556 of the discretion to determine that the applicable under section 556 and 557 title 5’’). The fact that Congress chose issues could be resolved entirely on the does not resolve the question. See, e.g., not to explicitly reference APA sections basis of the existing written record. See National Classification Committee v. 556 or 557 provides a strong indication Philips Petroleum, 475 F.2d at 848–849 U.S., 765 F.2d 1146, 1150–1151 (DC Cir. that they did not intend to impose such (Formal rulemaking under APA 556 not 1985) (Rejecting argument that formal a requirement on section 408 required even though statute required rulemaking required on grounds that proceedings. See, e.g., St Louis Fuel and that hearing be held, but ‘‘Commission ‘‘[u]nder Florida East Coast there is a Supply Co v. FERC, 890 F.2d 446, 449 has a very broad discretion in strong presumption that the procedural (DC Cir. 1989) (holding that formal determining the form of its guarantees of section 553 of the APA are hearing under APA 554 not required on proceedings’’). sufficient unless Congress specifically that grounds that ‘‘[w]e consider it EPA’s construction is confirmed by indicates to the contrary’’); Association significant that, unlike section 7193(c), the House Commerce Committee Report of National Advertisers v. FTC, 627 F.2d other prescriptions in the DOE accompanying the final bill, which 1151, 1165–1168 (DC Cir. 1979) (formal Organization Act expressly invoke the states: rulemaking not required, even though APA’’) (citations omitted). New subparagraph (g)(2)(B) allows an statute ‘‘did order use of procedures not Nor does any provision of FFDCA objector to request a public evidentiary required in informal rulemaking’’ such hearing. The Administrator would decide as rights to rebuttal and cross- section 408 include the requirement that whether [a] hearing were necessary to receive examination at public hearing.); the hearing be ‘‘on the record.’’ By factual evidence relevant to material issues of American Public Gas Association v. contrast, several other provisions of the fact raised by the objections. The Committee FPC, 567 F.2d 1016, 1065–1067 (DC Cir. FFDCA include that exact phrase. expects EPA to use this discretion fairly and 1977) (Formal rulemaking not required Compare, 21 U.S.C. 335a(i) (‘‘The to grant hearings to responsible parties on all sides. by statutory provisions requiring ‘‘full Secretary may not take action * * * hearing’’ and ‘‘substantial evidence’’ unless the Secretary has issued an order H.R. Rep. No. 104–669, at 49 (1996) standard of judicial review). for such action made on the record after (emphasis added). Notably, in an earlier In fact, the language and legislative opportunity for an agency hearing on version of the 1996 amendments, the history of section 408 provide clear disputed issues of material fact.’’); 21 House bill provided for a mandatory indication of Congressional intent not to U.S.C. 335b(b)(1)(A) (‘‘A civil penalty hearing during the notice-and-comment subject proceedings under these shall be assessed * * * by an order rulemaking stage of an EPA-initiated sections to APA sections 556 and 557. made on the record after an opportunity proceeding. [H.R. 1627, 104th Cong. FFDCA section 408 does not reference for an agency hearing * * *’’); 21 U.S.C. Section 405 (new FFDCA section APA sections 556 or 557 (see, e.g., 7 335(c)(b) (‘‘The Secretary may not take 408(e)(2)) (‘‘EPA shall provide an U.S.C. 136d(c)(2)). By contrast, the action * * * unless the Secretary has opportunity for a public hearing previous version of section 408 did issued an order for such action made on * * *’’) (emphasis added). This reference APA section 556, and the the record after opportunity for an requirement was dropped prior to deletion of this requirement provides agency hearing on disputed issues of enactment but the contrast with section clear evidence of Congressional intent material fact.’’) Under all rules of 408(g)(2)(B) confirms the discretionary not to exempt FFDCA from APA 553. statutory construction, those differences character of the latter. Prior to the 1996 amendments, section are presumed to be intentional. Russello If this were not sufficient indication 408(d)(5) of the original act, which v. United States, 464 U.S. 16, 23 (1983) of Congressional intent, further governed the conduct of hearings, (‘‘[W]here Congress includes particular evidence is provided by the fact that in specifically referenced APA 556. (‘‘Any language in one section of a statute and amending section 408, Congress chose report, recommendations, underlying omits it in another section of the same not to adopt the provisions of section data, and reasons certified to the Act, it is generally presumed that 701(e) that Petitioners cite in their Secretary by an advisory committee Congress acts intentionally and objections. Clearly, Congress could have
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adopted the same provisions found in show ‘reasonable grounds’). Further, required to be made on the record after FFDCA 701(e), or in any of the other although section 701 does not itself notice and opportunity for a hearing comparable FFDCA provisions contain the requirement that the hearing * * *’’ 33 U.S.C. 1369(c) (emphasis discussed above, but chose not to do so. be ‘‘on the record,’’ the legislative added).9 By contrast, FFDCA section EPA agrees that, when a hearing is history of this provision indicates that 408(i) merely provides that ‘‘[a]s to warranted, the FFDCA requires an Congress intended such hearings to be orders issued following a public evidentiary hearing that comports with ‘‘on the record.’’ Pactra, 555 F.2d at evidentiary hearing, the findings of the the procedures contemplated by 682–684 (detailing FFDCA section 701 Administrator with respect to questions 408(g)(2)(B). But that is not the same as legislative history). These characteristics of fact shall be sustained if supported by a requirement that section 553 be played a significant role in the court’s substantial evidence when considered inapplicable to the proceedings, or that decision that FDA lacked the authority on the record as a whole’’ (21 U.S.C. any hearing be held in accordance with to deny hearings under section 701(e) 346a(i)) (emphasis added). It is also APA sections 556 and 557.7 Rather, on the basis of summary judgment worth noting that the court expressly section 408’s provisions are consistent proceedings.8 However, as shown distinguished this case, which dealt with APA sections 553 (b) and (c), above, the legislative history of section exclusively with an adjudicatory which recognize the potential for 408 provides a clear indication of a proceeding, from those circumstances in hearings as part of informal rulemaking: contrary Congressional intent with which an agency proceeds through ‘‘Except when notice or hearing is respect to hearings under this section. rulemaking. 564 F.2d at 1262, n. 30. required by statute, * * * the agency Petitioner’s reliance on the In any event, even if section 556 did shall give interested persons an ‘‘substantial evidence’’ standard in apply to hearings under section 408, opportunity to participate in the rule FFDCA section 408(i) is equally Petitioners cannot avoid the case law making through submission of written misplaced. Incorporation of that under section 553 and EPA’s data, views, or arguments, with or standard into judicial review provisions interpretation of the interrelationship without the opportunity for oral alone has been consistently held to be between any hearing granted under presentation.’’ 5 U.S.C. § 553(b)(c) insufficient to indicate Congressional section 408(g)(2) and the rulemaking (emphasis added). intent to impose the full requirements of preceding it. Petitioners cite to the Finally, Petitioners’ citation to case APA sections 556 and 557 to a general evidentiary provision in section law interpreting FFDCA section 701(e) rulemaking. Wisconsin Gas Co v. FERC, 556(d) that provides that only irrelevant does not compel a different result. 770 F.2d at 1167 (‘‘The procedures or immaterial evidence may be excluded Petitioners claim that the provisions of required to develop this ‘substantial and argue that this generic standard FFDCA 701(e) are ‘‘near identical’’ to evidence’ are not necessarily the strict necessarily defines the scope of a those under section 408, and on this adversary procedures of sections 556 hearing regardless of the statutory basis, argue that, ‘‘by analogy’’ these and 557 of the Administrative scheme in which it is embedded. decisions compel an identical Procedures Act’’); Public Systems v. However, context matters. As the DC interpretation of the requirements of FERC, 606 F.2d 973, 979, n. 32 (DC Cir. Circuit noted, ‘‘the informal procedures FFDCA section 408 (Obj at 65). 1979) (substantial evidence requirement of section 553 of the APA and the more Petitioners are correct that section in Natural Gas Act ‘‘carries no formal requirements of sections 556 and 701(e) of the FFDCA has been held to implications for procedures to be 557 are not mutually exclusive.’’ be ‘‘one of those statutes, few in followed by the Commission in American Public Gas Association, 567 number, that does require rule-making compiling the record’’); American F.2d at 1067. Even the caselaw relied hearings to be on the record in Public Gas Association v. FPC, 567 F.2d upon by Petitioners does not suggest accordance with APA sections 556.’’ 1016, 1065–1067 (DC Cir. 1977) (‘‘In our that section 556(d)’s evidentiary Pactra, supra, 555 F.2d 677, 685 (9th view, however, this requirement [of the provision trumps all other Cir. 1977), citing Florida East Coast substantial evidence standard] in the considerations. Petitioners cite Railway, 410 U.S. at 237–38, (dictum). judicial review provision of the Act primarily to Catholic Medical Center, But in all other regards, Petitioners are does not dictate the procedure to be Inc. v. NLRB, 589 F.2d 1166, 1170 (2d incorrect. followed, or the nature of the hearing to Cir. 1978). In that case, the Second As previously discussed, there are be held). Circuit interpreted section 556(d) as several significant differences between The specific language of 408(i) defines specifying that ‘‘an agency thus may not the statutory language of FFDCA the standard for the reviewing court; it provide for the exclusion of evidence sections 701 and 408 that render does not describe the process by which not protected by a privilege or Petitioners’ citation to these cases the agency hearing is to be conducted. countervailing policy . * * *’’ Id. inapposite. Hearings are mandatory This is quite different from the language (emphasis added). Here, EPA has upon request under section 701, and the under 501(c) of the CWA, on which the interpreted its authority to impose such filing of objections operates to DC Circuit relied in holding that a countervailing policy. Moreover, automatically stay the provisions of the hearings pursuant to APA section 554 EPA’s interpretation is clearly within rule. Section 701(e)(2) requires only that were required. Marathon Oil v. EPA, the broad discretion granted it by the the objection ‘‘state the grounds 564 F.2d 1253, 1262–1265 (DC Cir. statute and the policy underlying the therefore,’’ rather than requiring the a 1977). The CWA section 501(c) states interpretation is a reasonable adaptation statement of ‘‘reasonable grounds.’’ See ‘‘[i]n any judicial proceeding * * * in of judicial practice with regard to issues Pactra at 684 (distinguishing FFDCA which review is sought of a not presented in notice and comment section 701(e) from 507(f) because the determination under this chapter rulemaking proceedings. Thus, latter requires hearing applicants to Petitioners’ technical and formalistic 8 Contrary to Petitioners’ allegation, the DC argument concerning section 556(d), 7 EPA’s regulations currently provide for a trial- Circuit has not ‘‘arrived at the same conclusion’’ which ignores the context of the section type adjudicatory hearing. These regulations were (Obj at 65). All of the discussion from Independent 408(g)(2) hearing provision, must be adopted under the preceding statutory provision, Cosmetic Manufacturers and Distributors v. U.S. and EPA has not yet undertaken any effort to revise Dept of Health, Education, and Welfare presented rejected. the regulations to take into account the revised in their objections is dicta from a dissenting Similarly unavailing is Petitioners’ provisions of section 408. opinion. 574 F.2d 553, 572 (DC Cir. 1978). argument concerning section 556(e)’s
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specification that the ‘‘exclusive record conducted to accurately reflect the use EPA’s policy is merely that the for decision’’ after a hearing is material under the registration, as modified by objections phase does not present an or testimony submitted in the hearing or FMC’s cancellation of uses and opportunity for parties to begin the hearing proceeding. Petitioners assert additional mitigation measures. The process entirely anew, by raising issues that this provision somehow removes same is true for the ‘‘new analysis of the or information that could have been any limitations on what can be various carbofuran labels;’’ the analysis fairly presented as comments on the submitted at the hearing because ‘‘that related to the labels submitted as part of proposed rule. Nor is the statute’s ‘exclusive record’ is independent of the September 2008 comments. The additional procedural step an excuse to whatever record may exist in the prior chlopyrifos studies were raised in withhold information that was clearly informal rulemaking * * *.’’ (Obj at 64). response to the Petitioners’ citation to a available at the time of the rulemaking. Yet the hearing record is not subset of chlorpyrifos data. They 2. Implications for FMC’s Submission ‘‘independent’’ of the rulemaking record acknowledge that the ‘‘new literature of New Registration Amendments as in that EPA regulations require that the citations’’ were provided to address one Part of their Objections. On June 29, rulemaking record be included in the of their contentions (Obj at 56). The sole 2009, in conjunction with their record of the hearing (40 CFR exception relates to EPA’s calculation of objections on the final rule, FMC 179.179.83(a)(1)). Once again, carbofuran-specific half-lives for use in Corporation submitted a request for EPA Petitioners’ argument fails because it the dietary risk assessment. As to amend its registration in several considers section 556 in isolation rather discussed in Unit VI.G.2, EPA does not regards. Some of the requested than taking into account the context of reject Petitioners’ challenge to EPA’s amendments were further mitigation the entire administrative proceeding in calculation of the 186-minute half-life measures intended to address which the hearing is embedded. on the basis that it is untimely.10 carbofuran’s dietary risks. The most Finally, Petitioners complain that A fair indication that EPA has not significant of these was a proposal EPA ‘‘raised a host of new issues and raised a host of new issues in the final intended to ensure that only 2% of any assertions for the first time in the Final rule is that, with the exception of the watershed would be treated with [rule],’’ and it would be inequitable for revised half-lives, Petitioners do not carbofuran. The proposal would require EPA to prevent them from raising challenge the substance of any of the that, within five days of applying the objections on these new assessments. allegedly ‘‘new’’ information. Indeed, as product, all applicators report to FMC Petitioners identify ten categories of discussed in the sections below, the following information: The location ‘‘new computations and contentions’’ Petitioners have in many instances that the product will be used, crop, use that they claim raise issues that go failed to address any of the explanations rate, application method, acreage, and beyond those addressed in their prior or revised analyses EPA presented in quantity applied. Based on this comments. With one exception, all of the final rule. information, FMC would track the these ‘‘new computations and Ultimately, Petitioners’ complaint percentage in each watershed. contentions’’ were revisions to analyses misses the point. EPA does not interpret ‘‘Whenever it appears that carbofuran conducted in response to Petitioners’ the statute and regulations to preclude has been applied to 1.75% of any comments. Indeed, some of these were the submission of any new information watershed,’’ the registrant would report revisions undertaken in response to as part of the objections phase. Such a that information immediately to EPA, Petitioners’ specific request; for position would in fact be inconsistent ‘‘cease further sales in any county that example, the ‘‘new’’ BMD analyses they with EPA’s own regulations and past overlaps with such a watershed for that identify were: (1) Corrections made in practice, which require that in order to use season, and shall attempt to recall response to an EPA error identified in support a hearing request, a party all unused carbofuran within such their comments; (2) an extrapolation of submit more than ‘‘mere allegations or counties by offering to repurchase such BMD50 s, using the dose-time-response denials’’ (40 CFR 178.32(b)(2)). Rather, unused product’’ (Exhibit 2). model, to develop a common point of EPA’s interpretation in this regard is Additionally, FMC requested that its comparison between all studies, which analogous to the determination of registration be amended to require that they had claimed was the appropriate whether a final rule is the logical ‘‘based on watershed boundaries, FMC approach; and (3) a calculation outgrowth of the proposal and the * * * prior to each use season, allocate generating a new dose-response model comments. For example, EPA does not to its distributors in a manner which in order to calculate the BMD50 s for reject Petitioners’ citation to new will attempt to ensure that no brain and RBC AChE inhibition, in studies in support of the contention that distributor receives more carbofuran for response to Petitioners’ claim that RBC AChE data are generally more sale than can be accommodated by the failure to do so was inappropriate (Refs. sensitive than PNS tissues on the 2% watershed area cap in any 24, 25, 85). Since these analyses were grounds that they are untimely. This is watershed supplied by that distributor.’’ done at their behest, they can hardly because these studies are simply more In addition, FMC proposed to add complain that they present new issues evidence supplementing the issue they geographic restrictions that would on which they had no opportunity to fairly raised in their comments, and are prohibit use in certain parts of the comment. The Agency’s underlying intended to rebut EPA’s response in the country. Specifically, they proposed to methodologies were the same as those final rule. Similarly, the submission of restrict the use of carbofuran on used for the proposed rule; the analyses new analyses relating to the ground potatoes to the three states: Idaho, were based on information provided by water pH in Exhibit 14 is not considered Oregon, and to select counties in the Petitioners and/or to address the untimely, as the issues they raise Washington. They proposed to restrict revisions requested as part of the relating to ground water pH were fairly use on Sunflowers to only Colorado, Petitioners’ comments. raised in comments and discussed Kansas, Nebraska, and South Dakota, as Regarding the remaining analyses: throughout the rulemaking. Ultimately, well as limited portions of North Dakota The ‘‘new exposure estimates for ground and Oklahoma. Under this proposal, use and surface water,’’ as well as the 10 The Petitioners’ claim that ‘‘EPA provided new on corn would be restricted to Colorado, ‘‘revised dietary risk and drinking water information concerning the raw data collected and Iowa, Illinois, Indiana, Kansas, records maintained by ORD in relation to its assessments’’ and ‘‘new assessment of toxicology studies’’ is inaccurate. EPA provided no Missouri, Nebraska, and limited the impact of buffers and setbacks’’ were new information on this topic in the final rule. counties in Wisconsin. Further, they
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proposed to add set-backs (i.e., areas administrative hearing. Therefore, the questions that are specific to FIFRA, where carbofuran could not be applied) commenters have made a good faith such as whether the steps proposed ranging between 100 and 1,000 feet from attempt to raise in these comments the could be adequately enforced, which drinking water wells, depending on the principal issues of which they are could affect the confidence that geographic area. Finally, as part of these aware’’ (Id.). everybody would, in fact, comply with amendments, FMC also requested that At this stage of the process, the statute all the steps, (e.g., who would EPA revise its registration to permit use requires the Petitioners to object to the investigate whether users have properly of carbofuran on pumpkins in Ohio, conclusions and provisions in EPA’s notified FMC of use of the product; Illinois, and Indiana, and to cancel the final rule, not to propose some new would users have to keep records to use on pumpkins in the southeastern alternate license that they claim would demonstrate to inspectors that they had United States. meet the statutory standards (21 U.S.C. appropriately reported use; how would As made clear in Unit VI.C., FMC’s 346a(g)(2)(A) (‘‘any person may file further sales in a county be prohibited); newly-proposed registration objections * * * specifying with and whether the steps themselves are amendments are irrelevant to the prior particularity the provisions of the appropriate tools from a policy determinations made in the final regulation * * * deemed perspective for dealing with risks tolerance revocation rule. Further, as objectionable’’). In fact, one might fairly associated with the use of a pesticide discussed in Unit VI.D., as a read their proposal as an admission that (e.g., is it appropriate to require users to consequence of the failure to raise these the existing license fails to meet the report use to a pesticide manufacturer; amendments measures as part of their statutory standards. is such reporting subject to approval comments on the proposal, EPA A further consideration is that the under the Paperwork Reduction Act; is considers that all issues arising question of whether these amendments it appropriate public policy to limit exclusively as a result of these proposed can be approved depends on whether sales in a watershed so that some amendments have been waived. There is the Agency eventually determines the growers may have preferential access to no evident reason that FMC could not amended registration meets the a product; would the scheme encourage have offered these amendments as part standards of FIFRA, which include early and potentially unnecessary of its September 2008 proposals. All of considerations beyond the dietary risks purchase of product by users; under the information on which they rely was evaluated under the FFDCA. Under what circumstances, if any, should EPA available in September of 2008. All of FIFRA, the Agency’s review of the approve label and license conditions the risk concerns that the amendments amendments is also subject to a that require the extra vigilance that were intended to address were statutorily mandated schedule would be required here of users, discussed at length in EPA’s proposed (established as part of the Pesticide distributors, and state and federal rule. Since 2006, EPA has clearly stated Regulatory Improvement Act (PRIA)). regulators). Even if this scheme were These are no small matters. In terms of its determination that carbofuran’s determined independently to meet the timing, FMC explicitly acknowledged in potential to leach into ground water and FFDCA safety standard, if ultimately its letter submitting the proposed to runoff into surface water caused EPA were unable to grant the amendments that the amendments were unacceptable dietary risks. EPA’s amendment based on the other subject to the PRIA review process, methodologies for evaluating these risks considerations that it must evaluate requesting that the actions be subject to have not changed since 2006. Indeed, under FIFRA, the unacceptable dietary the PRIA 8-month statutory deadline EPA deferred regulatory action for risks would still remain. Thus, whether several months, subsequent to the (which would establish a statutory this scheme could result in a Agency’s determination in 2006 that deadline of February 2010 for Agency determination that the dietary risks are carbofuran did not meet either the consideration of FMC’s application). It acceptable is not ultimately severable FIFRA or FFDCA standard, to allow the is not clear whether FMC is arguing that from the larger FIFRA process. Nor Petitioners time to generate data to its application be accorded a higher would it be appropriate to attempt to address the exact same issues these priority than other applications and be resolve FIFRA issues in a hearing under proposals are intended to address. In taken out of turn, or whether FMC is the FFDCA. their comments on the proposed rule, arguing that the consideration of the Petitioners provided some mitigation objections and request for hearing must Indeed it is questionable whether measures intended to address issues be delayed until the FIFRA review consideration of the proposed relating to the carbofuran’s leaching and process is completed. EPA rejects either amendments would be appropriate even runoff potential: Well set-backs, buffers, position; Petitioners cannot use this under Petitioners’ position that all geographic use restrictions, and aerial tolerance proceeding to evade FIFRA’s objections made in good faith may be application recommendations. statutory review scheme, or use that presented at this stage of the proceeding As previously discussed, EPA scheme to delay this tolerance (Obj at 61). For example, less than six provided clear notice in the proposed proceeding. months prior to their recent submission, rule that issues that that were not raised As noted, although FIFRA the Petitioners proposed voluntarily during the comment period would be incorporates the FFDCA dietary risk cancellation of all use on pumpkins considered waived in subsequent stages standard, FIFRA also requires the except in the Southeastern United of the administrative process (73 FR Agency to evaluate a much wider scope States, alleging that sales data 44,865). Petitioners were well aware of of issues in determining whether to demonstrated that carbofuran was this, as they commented that ‘‘EPA’s grant new license requirements. For needed in the Southeastern U.S. In requirement to raise all issues in the example, EPA must evaluate the impact response to this amendment, which was comments does not appear to be legally this proposal would have on worker and submitted as part of their comments on binding’’ (Ref. 18 at 118). Indeed they ecological risks. In addition, EPA must the proposed rule, EPA analyzed the acknowledged that they ‘‘agree that carefully evaluate the policy dietary risks based on this proposed use identifying disputed issues in the implications involved in authorizing pattern for the final rule. A request, comments is efficient and desirable, and Petitioners’ scheme. In this regard, it is mere months later, for additional use on may help to narrow the issues arising in worth noting that FMC’s scheme is a pumpkins in states with different subsequent objections and an novel one that raises significant policy geographic and weather conditions and
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cancellation of the use in the justify a hearing, as discussed in the safety factor—or no safety factor—‘‘will Southeastern U.S., may fairly be Units below. be safe for infants and children’’ (21 considered suspect—an action intended E. Response to Specific Issues Raised in U.S.C. 346a(b)(2)(C)). In determining to delay the revocation process by Objections and Hearing Requests whether a different factor is safe for forcing the Agency to conduct yet Relating to EPA’s Children’s Safety children, EPA focuses on the three additional analyses, rather than a good- Factor factors listed in section 408(b)(2)(C)— faith objection. the completeness of the toxicity To more fully understand Petitioners’ database, the completeness of the For all of these reasons, EPA has objection and hearing request with exposure database, and potential pre- determined that reliance on these regard to EPA’s choice of a 4X proposed amendments as a basis for children’s safety factor and EPA’s and post-natal toxicity. In examining raising objections to the final rule, or for responses, a little background is helpful. these factors, EPA strives to make sure requesting a hearing is not appropriate. Section 408 of the FFDCA imposes a that its choice of a safety factor, based Nevertheless, EPA evaluated the default additional safety factor for the on a weight-of-the-evidence evaluation, individual objections premised on the protection of infants and children, to does not understate the risk to children. newly requested terms and conditions take into account the fact that children (Ref. 79). The Agency’s approach to of registration. And in each case, the are frequently more sensitive to a evaluating whether sufficient ‘‘reliable’’ submitted materials relating to these pesticide’s effects than adults. This data exist to support the reduction or objections and hearing requests default 10X safety factor can only be removal of the statutory default 10X is independently failed to meet the revised if the Agency has ‘‘reliable data’’ described below in Figure 1. statutory and regulatory requirements to to demonstrate that the alternative BILLING CODE 6560–50–P
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BILLING CODE 6560–50–C evidence on carbofuran as to RBC AChE EPA has adequately accounted for all EPA has consistently required that inhibition in juveniles indicated that PNS effects in pups without the need for data comparing the AChE inhibition in effects on juveniles’ PNS might be the an additional children’s safety factor. young rat pups (typically PND11) and most sensitive endpoint, there was not They argue that brain data will adult rats be submitted on AChE- sufficient data to calculate a PoD (for adequately protect against PNS effects, inhibiting pesticides, such as use in determining the safe dose or based on the claim that the available carbofuran, to determine the extent of PAD) on these effects. Despite the data show that the brain is equally children’s potential sensitivity. The incompleteness of the toxicity database sensitive or more sensitive than PNS study measures the levels of AChE and the evidence indicating the tissue. In support of this objection, inhibition in both potentially relevant potential for pre- and post-natal toxicity Petitioners’ submit the evidence target tissues: The brain and either the at a very sensitive level, which indicate contained in Exhibits 4 and 6. Exhibit PNS or red blood cell (RBC), which the need to retain a children’s safety 4 consists of a report by Kendall serves as a surrogate for the PNS. EPA factor, EPA nonetheless determined Wallace, PhD, entitled ‘‘Expert Report: required these data from FMC for that, because there was limited reliable Carbofuran FQPA Safety Factor,’’ along carbofuran, and FMC on two occasions data in juveniles, a full statutory default with published studies conducted with submitted the studies. Both sets of data, 10X was not necessary to ensure that OP chemicals, and other NMC however, were rejected by EPA as children’s exposures would be ‘‘safe.’’ chemicals (Ref. 17, 51, 53, 54, 59, 61, 62, scientifically flawed because they EPA undertook a complex comparison 72). Exhibit 6 consists of a report by inaccurately measured the levels of RBC of the brain and RBC AChE data in Lucio Costa, PhD, entitled, ‘‘Expert AChE. juveniles and determined that the likely Report: Carbofuran’s FQPA Safety Despite the invalidity of the two FMC increased level of sensitivity for RBC Factor and Interspecies Uncertainty studies as to RBC AChE, EPA still has AChE inhibition is 4X. EPA thus Factor,’’ as well as published literature certain, limited RBC AChE data and concluded that using an additional studies conducted with chlorpyrifos and other PNS-related data on carbofuran children’s safety factor of 4X applied to disulfoton, both OP pesticides, and a from other studies. These other the PoD from data on brain AChE single study with propoxur, an NMC carbofuran data indicate the following: inhibition in juveniles would protect pesticide. (1) PNS-related effects (tremors) occur infants and children. i. Background. In the proposed in pups as a result of exposure to 1. Challenge to EPA’s Scientific Basis tolerance revocation, EPA presented its carbofuran at low doses; (2) juveniles for Retention of a 4X Children’s Safety rationale for retention of a children’s are more sensitive than adults to Factor. Petitioners object to EPA’s safety factor. carbofuran based on brain measures; (3) conclusion that the lack of peripheral As explained in Unit IV.A, EPA uses juveniles are more sensitive than adults tissue data justifies retention of any a weight of evidence approach to to carbofuran based on RBC AChE portion of the children’s safety factor. determine the toxic effect that will serve measures; and (4) the relative sensitivity Petitioners raise two claims in this as the appropriate PoD (or regulatory of juveniles compared to adults as to regard. First, they allege that a endpoint) for a risk assessment for RBC AChE is significantly greater the carbofuran PoD based on brain AChE is AChE inhibiting pesticides, such as relative sensitivity of juveniles adequately protective of PNS effects. carbofuran (Ref. 78). Neurotoxicity compared to adults as to brain AChE. It Second, they claim that RBC AChE resulting from carbofuran exposures can is also noteworthy that the data in adult inhibition data are not the best surrogate occur in both the central (brain) and rats showed RBC AChE was generally for PNS effects when brain data are peripheral nervous systems (PNS). In its more sensitive to carbofuran’s effects available, and therefore, these data are weight of the evidence analysis, EPA than brain AChE (RBC AChE inhibition not an ‘‘appropriate surrogate for PNS reviews data, such as AChE inhibition was higher than brain at every dose effects’’ and should not have been relied data from the brain, peripheral tissues except the lowest), although these data upon as the basis for retaining any and blood (e.g., RBC or plasma), in are of limited relevance, because they portion of the safety factor. In support addition to data on clinical signs and were conducted on adult animals rather of these points, Petitioners submit other functional effects related to AChE than pups, and adult responses are summaries of the testimony they intend inhibition. Based on these data, EPA frequently not predictive of children’s to offer at a hearing, along with copies selects the most appropriate effect on responses. However, because the of published studies that they allege which to regulate; such effects can available pup RBC AChE data from provide evidence of the points raised in include clinical signs of AChE EPA–ORD did not involve testing at the testimony. inhibition, central or peripheral nervous doses that produced a sufficiently low In essence, these two main issues tissue measurements of AChE inhibition level of inhibition, the data were not overlap, particularly with respect to the or RBC AChE measures (Id). Due to the sufficient to develop a PoD for juveniles evidence submitted. Petitioners rely on rapid nature of NMC pesticide toxicity based on RBC AChE. the same studies to support both points. it is difficult to document effects in the Accordingly, in making its children’s However, they are presented below PNS or even AChE inhibition in the safety factor determination for separately as discrete issues in the PNS and thus studies measuring AChE carbofuran, EPA was faced with three interest of clarity. Supplemental to these inhibition in the PNS are very rare for significant issues: (1) Sufficient data on two main points, EPA has identified NMC pesticides. Although RBC AChE carbofuran that are routinely-required three separate allegations made by inhibition is not adverse in itself, EPA’s for AChE-inhibiting pesticides to Petitioners in support of this objection, policy is to use it as a surrogate for measure PNS effects was not available; which are also analyzed individually in inhibition in peripheral tissues when (2) available data measuring the levels this section. peripheral data are not available. As of AChE inhibition in brain and RBC a. Objection/hearing request subissue: such, RBC AChE inhibition provides an indicated that juveniles were more Whether a carbofuran PoD based on indirect indication of adverse effects on sensitive than adults to carbofuran and pup brain AChE inhibition data alone is the nervous system (Id.). other carbofuran data indicated that adequately protective of PNS effects. There are laboratory data on PNS-related effects could occur in pups Petitioners argue that by establishing the carbofuran for cholinesterase activity in at low dose levels; and (3) although the PoD on pup brain AChE inhibition data, plasma, RBC, and brain from studies in
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multiple laboratory animals (rat, mouse, Finally, EPA explained that data from brain data, no additional safety factor dog, and rabbits). Among these are three other AChE inhibiting pesticides show would be necessary to account for studies that compare the effects of that direct measures of peripheral children’s increased sensitivity, because carbofuran on PND11 rats with those in nervous system (e.g., lung, heart, and ‘‘brain data are a better surrogate for the young adult rats (i.e., ‘comparative liver AChE) can be more sensitive than PNS than RBC data.’’ The comments AChE studies’) (Refs. 1, 2, 66). Two of brain AChE inhibition. To help also contended that RBC data are these studies were submitted by FMC illustrate, EPA gave an example of problematic in a number of regards, e.g., and one was performed by EPA–ORD. another chemical for which brain they are more variable. They also argued An additional study conducted by EPA– inhibition alone was not at all that EPA had generally relied ORD involved PND17 rats (Ref. 63). predictive of toxicity, to help explain exclusively on brain data for other NMC The studies in juvenile rats show a why the lack of carbofuran data was so pesticides, and that to require an consistent pattern that juvenile rats are significant. The example given was additional safety factor for carbofuran more sensitive than adult rats to the fenamiphos (an OP pesticide), where based on the lack of RBC AChE data was effects of carbofuran. These effects cholinergic toxicity (e.g., tremors, inconsistent with those other decisions. include inhibition of brain AChE in miosis, salivation) was observed In the final rule and response to addition to the incidence of clinical following inhibition of RBC, but not comments EPA responded to all of the signs of PNS neurotoxicity, such as brain, even up to maximally tolerated Petitioners’ claims, and tremors, at lower doses in the young doses (McDaniel and Moser, Ref. 53). comprehensively restated its reasoning rats. This pattern has also been observed Normally, EPA would regulate based that the lack of PNS inhibition data for other NMC pesticides, which exhibit on the most sensitive endpoint, which warranted retention of some portion of the same mechanism of toxicity as in this case would appear to be the the children’s safety factor for carbofuran (Ref. 81). The 2008 SAP, in effects on children’s PNS. However, as carbofuran (74 FR 68694–68695 (May its review of the carbofuran draft NOIC, discussed above, EPA lacked the 15, 2009)). In essence, EPA explained concurred with EPA that the brain information that would allow it to that Petitioners had not presented any AChE data clearly indicate that the establish a PoD (or regulatory endpoint) information that fundamentally altered juvenile rat is more sensitive than the based on the effects on children’s PNS. the available risk information before the adult rat (Ref. 36). EPA therefore established its PoD based Agency. Specifically, EPA concluded The Agency does not have any AChE on the AChE inhibition in pup brain. that, given that (1) the EPA–ORD data inhibition data for carbofuran in the Generally, by regulating based on pup clearly show that a surrogate measure of PNS tissue of adult or juvenile animals. data, EPA would directly account for the peripheral nervous system (RBC There is data on RBC AChE inhibition, any additional sensitivity that children AChE) in juvenile rats is more sensitive which is a surrogate for PNS tissue might have, because the safe levels to the effects of carbofuran than brain AChE inhibition, in adult animals at estimated from these data would be the AChE inhibition; (2) clinical signs both high and low doses, and RBC data levels at which infants and children consistent with toxicity to the in pups, but only at doses causing would be affected. In such peripheral nervous system were seen at greater than 50% AChE inhibition (a circumstances, EPA could reduce the very low doses of carbofuran; and (3) very high level of inhibition). In adults, children’s safety factor. data from other AChE inhibiting the data show that RBC is generally But because EPA lacked the data on pesticides show that direct measures of more sensitive to the effects of the PNS effects in pups at low doses of peripheral nervous system (e.g., lung, carbofuran than the brain, but that at the carbofuran, which are most analogous to heart, and liver AChE) can be more lowest dose tested, brain and RBC have the exposures that infants and children sensitive than brain AChE inhibition, similar sensitivity. In pups, the will receive from eating food with the Agency could not be confident that available data at higher doses show that, carbofuran residues, the Agency could assessing risk using brain AChE like adults, RBC is more sensitive than not be confident that assessing risk inhibition would be protective of brain. For example, the EPA–ORD using brain AChE inhibition would be potential effects in the peripheral studies showed that RBC AChE protective of potential effects in the PNS nervous system for infants and children. inhibition is more sensitive than brain for infants and children. Accordingly, ii. Denial of hearing request. EPA is AChE inhibition in both PND11 and EPA determined that, even though the denying Petitioners’ hearing request on PND17 pups at the lowest dose tested. Agency was relying on pup data, this subissue because the evidence However, the lowest dose (0.1 mg/kg) in consistent with the statutory mandate proffered, even if established, is both studies missed the lower portion of that an additional safety factor be insufficient to justify the factual the RBC AChE inhibition dose-response applied to account for children’s determination urged (40 CFR curve for pups. At the lowest dose, PND increased sensitivity in the absence of 178.32(b)(2)). The totality of the 11 pups had approximately 40% brain information affirmatively demonstrating evidence submitted fails to demonstrate and 53% RBC AChE inhibition while that no such safety factor is necessary, a reasonable possibility that exclusive PND17 pups had approximately 25% the Agency could not conclude that reliance on carbofuran brain data will brain and 50% RBC AChE inhibition. removal of the statutory default 10X be protective, largely because they have Consequently, the Agency does not have would be ‘‘safe for infants and failed to proffer any evidence on several RBC AChE inhibition data in pups at the children.’’ As some information was points that are critical to their argument. low doses (i.e., those that cause only available to characterize the effects on As such, the objection rests on 10% inhibition) that are relevant to risk infants and children, EPA concluded speculation and mere allegation, and a assessment to serve as a surrogate for that the full default 10X was hearing will not be granted on this basis PNS tissue data. unnecessary, and that it could safely (Id. See, e.g., 73 FR 42708 (July 23, EPA explained that additional reduce the factor to 4X. 2008); 57 FR 6667, 6671 (February 27, evidence for the sensitivity of the PNS Petitioners raised many of the same 1991)). to carbofuran’s effects comes from data assertions in their comments on EPA’s It is important to remember that to in pregnant rats exposed to carbofuran proposed rule that they raise in their obtain a hearing on EPA’s children’s that showed clinical signs that may be objections. For example, the Petitioners safety factor decision, Petitioners must indicative of peripheral toxicity. claimed that because EPA relied on pup proffer more than evidence on whether
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EPA erred, Petitioners must proffer that was specific to carbofuran’s effects the relative sensitivity between the evidence showing there is ‘‘reliable on the PNS was data in adult rats. No central and peripheral nervous systems data’’ supporting the children’s safety evidence was submitted to demonstrate varies depending on the chemical factor they urge. Without the latter, their that adult data are generally predictive involved, which cannot establish that objection is immaterial because the of responses in pups. Nor was any exclusive reliance on brain data as a default position is retention of an evidence submitted to support the general proposition will always be additional 10X safety factor. assumption that pups will respond to protective of PNS effects in pups. Nor Accordingly, EPA has evaluated low doses of carbofuran in the same way can it establish that reliance on the Petitioners’ proffers on its children’s as adults. Thus their evidentiary proffer brain data will be protective of the PNS safety factor claims in terms of whether is effectively based on mere speculation effects in the case of carbofuran. they are sufficient to provide the that adult data will be predictive of pup When data are not available for a ‘‘reliable data’’ needed to justify the 1X responses, which cannot justify a specific chemical, conclusions based on safety factor that Petitioners propose. hearing (40 CFR 178.32(b)(2)). As EPA other chemicals can only be For purposes of resolving whether the previously explained in the proposed scientifically supported if it has been statute requires the retention of a and final rules, responses in adult rats demonstrated that the conclusion is children’s safety factor, the critical issue are not necessarily predictive of, or always true. If, ‘‘in some cases,’’ the is whether sufficient data exists to relevant to, responses in juveniles since conclusion is not true, then in the determine the effects on children’s the metabolic capacity of juveniles is absence of data on the specific peripheral nervous systems from low less than that of adults (73 FR 44864, 74 chemical, the conclusion cannot be doses of carbofuran. None of the FR 23046). As such, juvenile rats can be made for that chemical, and uncertainty evidence submitted affirmatively more sensitive to some toxic agents. exists regarding the effects of the addresses this question. As discussed in Simply put, studies that only involve individual chemical. Since there are no more detail below, the only evidence adult animals, therefore, do not provide data on the effects of carbofuran in PNS proffered in support of this objection information on effects on the young, tissues or RBC data at low doses in was: (1) A subset of the available which is the focus of the children’s pups, even assuming that they were able carbofuran data from adult animals; and safety factor. No matter how much to prove that for the specific chemicals (2) data, primarily in adult animals, evidence Petitioners can amass showing identified, the CNS is sometimes more from other chemicals to demonstrate that brain AChE is protective of RBC sensitive than the PNS, significant that generally, reliance on brain data AChE in adult animals, that does not uncertainty would remain regarding will be protective of PNS effects, and relieve the uncertainty concerning carbofuran’s effects on the PNS. This is therefore EPA can assume that the same potential sensitivity of PNS tissues in because the only evidence specific to will hold true for carbofuran. However, juvenile animals, particularly when all the effects of carbofuran on the PNS at the Petitioners have failed to submit any of the existing carbofuran data shows low dose levels that can be used as a data to demonstrate that the effects seen that pups are more sensitive than adults comparison with the brain AChE levels in adults will be predictive of the effects to the effects of carbofuran, and that is the adult RBC data. This also affects the materiality of this in juveniles. They have also submitted clinical signs consistent with toxicity to objection. If the adult RBC AChE data no evidence specific to carbofuran that the PNS were seen in pups at very low are not considered, as Petitioners demonstrates the effects of low doses on doses of carbofuran. Accordingly, in the suggest, no carbofuran-specific data children’s peripheral nervous systems. absence of carbofuran data in pup PNS This is critical because the evidence exists to demonstrate the level of AChE tissues or a surrogate such as RBC data, they do proffer on other chemicals fails inhibition in the PNS of either adults or the Petitioners’ evidentiary proffer fails to establish that as a general matter, pups at the low dose levels relevant to to establish a reasonable possibility that reliance on brain data will always be risk assessment. Thus, even assuming this issue could be resolved in their protective of the effects on the PNS. The Petitioners could successfully establish favor. A hearing is not appropriate in majority of the evidence in other every point they raise in this regard, the such cases (40 CFR 178.32(b)(2)). chemicals actually proves that reliance fact still remains that a decision maker The central tenet of this objection is on brain data is frequently not would have no data that provides any that regulating based on the effects in protective of the effects on the PNS. information relating to the potential the CNS will ensure that the PNS is And the remainder of the evidence on effects of carbofuran on a child’s PNS. this point, taken in the light most protected. In this regard, Petitioners do Given that FFDCA section 408(b)(2)(C) favorable to the Petitioners, provides cite to studies in juvenile animals, but compels the application of a 10X safety all of them are conducted with factor in the absence of information to only equivocal support for Petitioners. 11 Such evidence, by itself, is insufficient chemicals other than carbofuran. account for the presumptive sensitivity to relieve the uncertainty that remains Moreover, the Petitioners’ evidence fails of children, the lack of any data bearing with respect to carbofuran, based on the to demonstrate that the PNS can never on carbofuran’s PNS effects would affirmative evidence in carbofuran- be more sensitive than the CNS, or even require the Agency to apply a 10X safety specific data, showing that reliance on that the PNS is typically less sensitive factor, rather than the 4X factor applied brain data may not be protective. And than the CNS. Rather, the evidence in the final rule. such evidence, that entirely fail to shows only that the CNS (brain) is A further flaw in the Petitioners’ address the points that the statute makes sometimes more sensitive, and evidence is that it is internally central to a determination of the sometimes less sensitive than the PNS, inconsistent. Notwithstanding their appropriate children’s safety factor, depending on the chemical involved. allegations (discussed in subissue b cannot justify a hearing. Because the data do not show a below) that RBC data are inherently When examined more closely, their consistent pattern, it indicates only that unreliable and should be discounted in overall evidentiary proffer is even less favor of brain data, the carbofuran adult impressive. As discussed, much of the 11 Most of the studies were conducted on OP RBC data are one of the primary pieces chemicals, and expressly caution against extending evidence was conducted in adult rats. the results to NMC chemicals such as carbofuran; of evidence proffered to support the Indeed the only evidence Petitioners a point also raised by Petitioners’ own experts (Ex claim that reliance on the carbofuran submitted in support of this objection 4, 6). pup brain data will protect against all
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potential PNS effects (Exhibit 4). As of concern due to carbofuran is nervous Petitioners have presented nothing that discussed in more detail below, the system AChE. Brain is a direct measure challenges the substance of EPA’s Report cites to the carbofuran data with of such toxic effects, while RBC not response. Consequently, these claims do adult rats to conclude that brain AChE linked to any biological function.’’ On not present a live controversy as to a inhibition correlated closely with RBC this basis, they conclude that brain material issue of disputed fact; both AChE inhibition. ‘‘This was further represents the most appropriate parties agree on the facts at issue, which substantiated by the study published by endpoint for risk assessment. is that the brain responds rapidly to McDaniel et al. (Ref. 54), where they Essentially this testimony fails to carbofuran. Moreover, a simple report that the ‘lowest dose of prove any dispute of material fact. EPA repetition of comments made on the carbofuran (0.10 mg/kg) significantly relied on the carbofuran pup brain proposal without more is insufficient to decreased brain ChE activity but not AChE inhibition data to establish warrant a hearing. See, e.g., 73 FR at RBC ChE or motor activity’ * * *’’ (Id. carbofuran’s PoD. The Petitioners have 42698–42699 (July 23, 2008) (denying at 4, 6). Yet having granted scientific not argued that PNS effects are several NRDC hearing requests because validity to the adult RBC data, they irrelevant. Indeed, their submissions the objections were based on EPA’s must also concede the relevance of the make clear that effects on the PNS are preliminary DDVP risk assessment, EPA–ORD carbofuran pup RBC data, appropriate considerations in a risk rather than the revised risk assessment which clearly demonstrate that at every assessment; the only point they dispute published with the final order); 53 FR dose tested, RBC AChE, and therefore is whether brain or RBC data best 53176 (December 30, 1988) (where FDA the PNS for which it is a surrogate, is account for those effects (Exhibits 4, 6). responds to a comment in final rule, more sensitive than the brain in juvenile Alternatively, if they intend to argue repetition of comment in objections rats exposed to carbofuran. They raise that RBC data entirely lacks any does not present a live controversy no challenge specific to the scientific scientific validity, this is contradicted in unless objector proffers some evidence validity of the EPA–ORD data, but rely several places by their other objections calling FDA’s conclusion into question); only on their generic challenge that RBC and their own submissions. As 62 FR 64102, 64105 (December 3, 1997) data are inherently less reliable than discussed above, the commenters rely (objector claimed that addition of brain data. No hearing is warranted on the adult carbofuran RBC data to ethoxyquin invalidated studies; hearing based on such evidence. See 49 FR 6672 support their claim that reliance on the denied because objector did ‘‘not (February 22, 1984) (challenge to one of pup brain data is adequately protective dispute FDA’s explanation in the final five related studies; in the absence of of PNS effects. Moreover, they explicitly rule as to why addition of ethoxyquin any additional data bearing on the acknowledge that reliance on RBC data did not compromise the CIVO studies, clinical study, the objection constitutes is scientifically valid in the context of and provided no information that would nothing more than an allegation); 68 FR the human data (Obj at 13). have altered the agency’s conclusion on 46403 (August 5, 2003) (hearing denied Consequently, the submitted materials this issue’’). because cited studies only contained are insufficient to justify the factual Petitioners’ second point—that brain equivocal statements supporting determinations urged, and therefore fail AChE inhibition correlates closely with objector’s position). to support a determination that an PNS inhibition, and demonstrates that Accordingly, the sum of their evidentiary hearing is warranted (40 reliance on brain data will be protective evidence is no more than mere CFR 178.32(b)(2)). of the PNS—is a disputed material issue speculation that the effects of (b) Testimony purporting to show that of fact that could warrant a hearing, carbofuran exposure in the CNS will be reliance on brain data is sufficiently except that none of the evidence protective of effects in the PNS. This protective of the PNS. The Petitioners submitted in support of this point falls far short of the ‘‘reliable data’’ on raise several arguments in this regard. presents a reasonable possibility that the the safety of infants and children First, they allege that, ‘‘brain responds Petitioners could establish the points needed to justify the entire removal of rapidly to carbofuran, which readily alleged. Consequently, they have failed the 10X children’s safety factor and thus passes blood/brain barrier’’ (Obj at 12– to demonstrate that a hearing is cannot justify a hearing (40 CFR 13). Petitioners’ primary point, however, warranted on this objection (40 CFR 178.21(b)(2)). See, e.g., 73 FR 42697 is that ‘‘the extent of brain inhibition by 178.32(b)(2)). (July 23, 2008) (denying hearing where carbofuran more accurately compares (c) Exhibit 4. This exhibit consists of the only evidence submitted was with the extent of PNS inhibition, and a report by Kendall Wallace, PhD, NRDC’s claim that if the DDVP two- therefore brain data are adequately entitled ‘‘Expert Report: Carbofuran generation rat reproduction study had protective’’ (Id.). In support of this FQPA Safety Factor,’’ along with been conducted pursuant to the 1998 claim, Petitioners cite to Exhibits 4 and published studies (Ref. 17, 51, 53, 54, guidelines it might have shown 6, containing a mixture of ‘‘expert 59, 61, 62, 72). The report argues that, endocrine effects at lower doses than testimony’’ and published studies. None ‘‘it is my opinion that for carbofuran, the doses at which DDVP’s of the information contained in these the evidence indicates that inhibition of cholinesterase effects were seen on exhibits is sufficient to establish a brain AChE is an appropriate surrogate grounds that this was mere speculation); reasonable possibility that this issue for PNS AChE inhibition and that there 57 FR 6667 (February 27, 1992) (hearing could be resolved in their favor. is reasonable certainty that a PoD for denied to an objector who challenged Petitioners’ first claim simply carbofuran based on brain AChE FDA’s rejection of a study for only reiterates points made in their inhibition is protective of any adverse containing partial histopathological data comments on the proposed rule. As CNS and PNS effects.’’ The only on the grounds that ‘‘[s]peculation explained in the final rule, EPA agrees carbofuran evidence directly cited in regarding data that do not exist cannot that the data show that the brain support of this allegation is data serve as the basis for a hearing’’). responds rapidly to carbofuran, and that conducted on adult animals, using RBC A detailed examination of Petitioners’ it readily passes the blood/brain barrier. AChE data, which they elsewhere try to evidence follows below. However, evidence regarding the speed discount. This assumes that adults and (a) Testimony intended to show that with which the brain reacts proves pups are similarly sensitive despite the brain is the appropriate endpoint. nothing with regard to the relative carbofuran-specific evidence to the Petitioners allege that the ‘‘critical effect sensitivity of PNS tissues (Ref. 85 at 46). contrary. No evidence is discussed or
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submitted to support this assumption. the chlorpyrifos data failed to prove conceding that this study shows that the This therefore constitutes a mere their claim. CNS tissues in adult rats are more allegation, which does not justify a Chen, et al. (Ref. 17), another study of sensitive to the effects of physostigmine hearing. chlorpyrifos, discussed whether plasma than the PNS tissues, the data in this None of the published studies or RBC AChE should be used to study is of limited relevance to the issue conducted with other chemicals cited in establish a regulatory endpoint in at hand, which is the effects in the Report provide more than equivocal humans and compared data from several juveniles. Thus it is ultimately support for the points above; in fact, in animal studies, some of which were insufficient to affirmatively support the several instances, the study results conducted with adults and some with Petitioners’ claim. support EPA rather than the pups. This is the only study in Exhibit In sum, based on the evidence Petitioners.12 The studies contained in 4 that contains data on pups. The results contained in this exhibit, EPA this exhibit fall into two general of one of the studies reported in Chen, concludes that there is not a reasonable categories. The first group of studies et al. shows that at the lowest doses, probability that the proffered evidence consists of a subset of the chlorpyrifos inhibition was greater in the heart, would resolve the issue in Petitioners’ literature—which is generally more which is part of the PNS, than in the favor, and that consequently no hearing relevant to the subissue discussed in the brain (56% and 41% respectively); note is warranted on this basis. First, all but next objection, arguing that RBC data that these are the data in adult rats one of the studies discussed in this are not a good surrogate for the PNS— reported in Nostrandt et al. (described exhibit were conducted with adult rather than demonstrating affirmatively above). Based on data from a animals, rather than pups. As such, they that brain is a protective surrogate for developmental study of chlorpyrifos by provide evidence of little relevance to the PNS. The second category of studies Hoberman (Ref. 37), Chen et al. reported the question of whether pups’ PNS are is one paper on physostigmine, a that the doses estimated to produce 50% more sensitive than the CNS. In the carbamate, that is discussed in the body inhibition in heart and brain actually absence of carbofuran PNS data, or pup of the report. All but one of these show that in 5-day old pups (both males RBC data, much of this evidence is studies was conducted using adult rats. and females), the heart is 2–3 times effectively mere speculation about Marable, et al. (Ref. 51) and Nostrandt more sensitive than brain. Thus, this whether adult data will be predictive of et al. (Ref. 59) are two of the study contradicts Petitioners’ claim that pup responses, which cannot justify a chlorpyrifos studies Petitioners brain data will be protective of PNS hearing (40 CFR 178.32(b)(1)). submitted as part of the comments on effects, since the PNS inhibition was (d) Exhibit 6. This exhibit consists of the proposed rule, and they contain greater than brain at the lowest doses in a report by Lucio Costa, PhD, entitled, little evidence to demonstrate that brain both adults and pups. And in fact, it ‘‘Expert Report: Carbofuran’s FQPA data correlate well with the PNS, and supports EPA’s concern that the absence Safety Factor and Interspecies thus are generally protective of the PNS. of data at low doses is significant Uncertainty Factor,’’ as well as Marable et al. involved chronic because the effects at low doses can published literature studies conducted exposures to adult dogs; in addition to differ significantly from those at higher with chlorpyrifos and disulfoton, both the fact that adult animals were used, doses. The data from Hoberman showed OP pesticides, and a single study with and therefore provide evidence of little that at higher doses, ranging from 30– propoxur, an NMC pesticide (Refs. 71, relevance to the question at issue, there 100 mg/kg, the levels of inhibition in 19, 20, 21, 61, 52, 41, 64, 16). According are significant differences between the the brain were higher than the levels in to Costa, these studies generally show results of chronic and acute exposures. the PNS (Ref. 37 at 16)—the exact that there was similar or greater AChE As a result of the repeated exposures, opposite of what occurred at the lowest inhibition in brain than in the PNS blood, brain and peripheral tissues were doses. tissues of heart, ileum, or the at steady state, which cannot occur from The second group of studies consists diaphragm, which Petitioners claim an acute exposure, and therefore this of data on NMC chemicals. McDaniel et proves that reliance on carbofuran pup study can provide no information on the al. (Ref. 53) and Padilla et al. (Ref. 62) brain AChE inhibition data will effects from acute exposures. Nostrandt were cited in support of the claim that necessarily be protective of all effects in et al. actually reported that, following a the difference in sensitivity between the the PNS (Exhibit 6 at 3). The exhibit single low dose of chlorpyrifos, brain brain and RBC is generally less for NMC also references a human incident study inhibition was less (not greater) than the chemicals. These studies were (Ref. 50) of carbamate poisoning in early inhibition obtained in heart which is conducted with adult animals, and so childhood and in adults, claiming that, part of the PNS (although higher do nothing to address the question ‘‘Lifshitz * * * showed that signs of inhibition was not seen in the before the Agency with respect to pups. adverse effects in the CNS, rather than diaphragm or retina, other parts of the These studies merely confirm the PNS, prevailed in young children at the PNS). At higher doses, the inhibition in existing carbofuran data in adults, low dose levels covered by the paper.’’ brain and peripheral tissues were more which shows that at the lowest dose EPA concludes that there is not a similar. Thus, this study contradicts the tested, brain and RBC are essentially the reasonable probability that the evidence Petitioners’ claim that brain data will be same. contained in this exhibit would resolve protective of all PNS effects. Petitioners Somani et al. (Ref. 72) is a study on the issue in Petitioners’ favor. The offer no explanation of how the another NMC chemical, physostigmine, results of these studies fail to in adult animals, cited to support the demonstrate the point for which resubmission of these studies addressed claim that ‘‘in adult rats, brain AChE is Petitioners cite them—that brain AChE EPA’s conclusion in the final rule that somewhat more sensitive than RBC or is always equally or more sensitive than 12 It is interesting to note that, in Exhibit 4, the peripheral AChE to inhibition by acute PNS AChE, and therefore exclusive expert actually faults EPA for comparing OP and doses of physostigmine.’’ As an initial reliance on brain data can be assumed NMC pesticides, saying ‘‘Although OP pesticides matter, it is unclear that this study to be protective. Consequently, the fact inhibit AChE, they are completely different from provides more than equivocal support that Petitioners can identify examples of carbofuran and other N-methylcarbamates * * *:’’ (Exhibit 4 at 4). Yet the Exhibit includes papers on for their claim; the study authors claim other chemicals, whether OPs or NMCs, effects of chlorpyrifos, an OP, and these papers are only that the brain ‘‘appears’’ to have that sometimes affect the brain more not discussed in the text of the Exhibit. the lowest values. However, even severely than the PNS does not prove
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that this will be the case with using pups of varying ages, whether The study presents no data on the dose carbofuran. Furthermore, in several of brain or peripheral tissues were most levels associated with the poisoning the cited examples the Petitioners inhibited depended on the age of the incidents, and in fact concludes that misinterpret the findings, which pups and the dose. Nevertheless, Carr there was ‘‘insufficient information to actually support EPA’s position. (2001) showed that brain inhibition compare the doses ingested by [adults As explained in EPA’s final rule, decreased as the age of the pups and children].’’ However, based on the Petitioners are relying on only a subset increased, even though inhibition in the symptomology reported (comas, stupor, heart tissues did not. In other words, the of the chlorpyrifos data. The data, when and severe hypotoxicity) it is likely that submitted material only supports a examined in total, do not support a the doses were high, not low, as the conclusion that brain is sometimes conclusion that brain data will always Report claims. Also, this study cannot inhibited by chlorpyrifos to the same be protective of PNS effects (74 FR be used to discount PNS effects in degree as the peripheral tissues, and in 23054–23055 (May 15, 2009)). But even children; a large percentage of the reality, the studies show that brain is children clearly showed PNS effects relying solely on the studies Petitioners often inhibited to a lesser extent than reference in this exhibit, it is clear that (myosis, diarrhea). In addition, because peripheral tissues. This cannot support this was a retrospective study of brain is not always inhibited to the same a conclusion that reliance exclusively degree as peripheral tissues, nor is it patients admitted to a hospital intensive on brain data will necessarily be care unit, given the severity of some of always protective of peripheral tissues. protective in the absence of some The data in Padilla et al. (Ref. 61) are the CNS symptoms, such as comas, it is additional carbofuran-specific evidence. not unlikely that even if the subjects the only chlorpyrifos data that support The results are similar for the a conclusion that reliance on the CNS also showed PNS symptoms, they were disulfoton studies. Schwab et al. (Ref. not reported. Finally, the study authors’ data will be protective of the PNS. 71) shows that after both a single dose However, the Padilla study involved conclusion was that in children, the and repeated doses, the brain and ‘‘clinical presentation [of carbamate chronic dosing of rats via the feed, and peripheral tissues were equally as such, cholinesterase measurements poisoning] differs from adult poisoning inhibited. However, these results are manifestations’’ (Ref. 50). Or in other reflected steady-state conditions. This contradicted by Costa et al. (Ref. 19) and words, that the effects in adults from study cannot provide information Costa and Murphy (1983), where the exposure to carbamates such as relevant to acute exposure. None of the results varied depending on the dosing carbofuran are not necessarily other chlorpyrifos studies referenced in and the brain area examined. In Costa predictive of the effects in children. It this exhibit support this conclusion. In and Murphy (Ref. 21), diaphragm is difficult to see how this study could Mattson et al. (Ref. 52), and Hunter et tissues were more inhibited than brain be fairly argued to support Petitioners’ al. (Ref. 41), following a single dose to tissues after a single dose of disulfoton, allegations. pregnant dams, heart and liver tissues while after repeated doses, brain and were more inhibited than brain tissues. diaphragm tissues were similarly In conclusion, the totality of the Similarly, in Richardson and Chambers inhibited. Thus, the relative sensitivity evidence in Exhibits 4 and 6 fail to (Ref. 64), where repeated doses were between CNS and PNS changes with support Petitioners’ contention. As administered to pregnant dams, at both repeated dosing, and these studies shown in Table 1 below, the majority of the low and high doses, the lung tissue provide no information on RBC the study results demonstrate that the was more inhibited than the brain tissue inhibition with which to compare the PNS is frequently more sensitive than in the one-day old pups. In Carr et al. other tissues. the CNS. The remainder, taken in the (Ref. 16), the results were more Finally, the Lifshitz study does not light most favorable to the Petitioners, equivocal; in a repeated dosing study support the claim for which it was cited. provide merely equivocal support.
TABLE 1—SUMMARY OF PETITIONERS’ STUDIES
Study design Relative inhibition Is CNS protective of PNS?
Chlorpyrifos Studies
Padilla et al. 2005 ...... Single dose, adults ...... RBC > brain ≈ diaphragm ...... Yes (same sensitivity). Mattsson et al. 2000 ...... Single dose, pregnant dams ...... RBC > heart > brain ...... No. Hunter et al. 1999 ...... Single dose, pregnant dams ...... Liver > brain ...... No. Blood not measured. Richardson and Chambers 2003 ... Repeated doses to pregnant Low dose, lung > serum ≈ brain > No. dams, measured pups at 1 day heart. old (not direct dose). High dose, lung > brain ≈ heart > serum. Note, serum has only ≈ 50% AChE, not true measure of AChE. Carr et al. 2001 ...... Repeated doses to pups ...... PND6: brain ≈ diaphragm > heart Not always, depending on age, ≈ lung > skeletal muscle ≈ dose, and brain region. serum. PND10: heart ≈ hindbrain ≈ dia- phragm ≈ lung > skeletal mus- cle > forebrain ≈ serum. PND16: heart ≈ lung > brain. PND20: heart > lung > brain. PND25: brain > PNS. Brain inhibition decreased with age, heart did not.
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TABLE 1—SUMMARY OF PETITIONERS’ STUDIES—Continued
Study design Relative inhibition Is CNS protective of PNS?
Nostrandt et al. 1997 (also cited in Acute dose, adults ...... RBC > heart > brain > diaphragm No. Chen et al. 1999). Hoberman 1998 as cited in Chen Repeated doses to pregnant RBC > heart > brain ...... No. et al. 1999. dams, measured in pups at 5 days old (not direct dose).
Disulfoton Studies
Schwab et al. 1981 ...... Single dose ...... heart ≈ ileum ≈ brain ...... Yes, similar sensitivity. Repeated doses ...... brain ≈ ileum > heart No blood measured Costa et al. 1981 ...... Single dose ...... Brain > ileum ...... Not always, depends on dosing Repeated doses ...... Forebrain > ileum > hindbrain ...... paradigm and brain region. Brain ≈ ileum ...... Not consistent within same study. Repeated doses ...... No blood measured. Costa and Murphy 1983 ...... Single dose ...... Diaphragm > brain ...... Not always, depends on dosing Repeated doses ...... Brain ≈ diaphragm ≈ plasma. paradigm. Note, plasma has only ≈ 50% AChE, not true measure of AChE.
Accordingly, Petitioners’ proffer is juvenile rats. There are no AChE data potential effects in the peripheral facially insufficient because there is no from peripheral tissues. Lack of nervous system for infants and children. reasonable possibility that it can peripheral AChE data is typical of For example, in the first FMC-sponsored establish a necessary element of NMCs due to the rapid reactivation of comparative ChE studies (Ref. 4) every Petitioners’ objection—that there are AChE. As a matter of science policy, the pup at the 0.3 mg/kg dose group ‘‘reliable data’’ that show it would be Agency typically uses AChE data from exhibited tremors. The range-finding safe for infants and children to remove blood, particularly RBCs, as a surrogate portion of the second FMC-sponsored entirely the 10X children’s safety factor. measure for the peripheral nervous comparative ChE study (Ref. 1) resulted iii. Denial of objection. The objections system (Refs. 76, 87). In the case of in tremors in rats exposed to 0.3 mg/kg do not address the fundamental issue carbofuran, RBC AChE data from two carbofuran (2⁄5 males and 2⁄5 females) that EPA is required by the statute to separate studies submitted by FMC are within 15 minutes post-dosing. resolve: Are there ‘reliable’ data to considered unreliable and unusable in Additional evidence for sensitivity of support reduction or removal of the human health risk assessment (Ref. 83). the PNS comes from carbofuran data in statutory 10X for protection of infants Data from EPA’s ORD includes high pregnant rats that showed clinical signs and children? The statute compels that quality RBC AChE data, but only high that may be indicative of peripheral EPA may only revise the 10X default doses were used in the ORD studies. toxicity. The California Department of safety factor if, ‘‘on the basis of reliable Data at the low end of the dose response Pesticide Regulation (CDPR) has data’’ EPA can conclude that the curve are not available for assessing the calculated a BMD10 and BMDL10 of 0.04 alternative safety factor will be ‘‘safe’’ effects in juvenile rats, which are the and 0.03 mg/kg/day, respectively, for (21 U.S.C. 346a(b)(2)(C)). The statute doses relevant for human health risk mouth smacking and chewing in also requires EPA to account for the assessment. Thus, because reliable data pregnant rats exposed to carbofuran. ‘‘completeness of the toxicity data’’ in are available to assess affects on the These signs are early indicators of making this determination (Id). In this CNS and some surrogate data are toxicity from some cholinesterase case, the Agency concluded that there available to assess the PNS, the Agency inhibitors (Ref. 56). This is notable for are sufficient data to reduce the 10X believes that the children’s safety factor two reasons. First, cholinergic toxicity safety factor but there is insufficient can be reduced. However, this factor (e.g., tremors, miosis, salivation) may be information to justify removing the cannot be completely removed since the observed following inhibition of blood, factor entirely. available carbofuran data show that RBC but not brain, cholinesterase. This was Similar to other AChE inhibiting AChE inhibition in pups is more the case with fenamiphos (an OP pesticides, carbofuran can affect both sensitive than brain AChE inhibition. pesticide), even up to maximally the central and peripheral nervous Given that (1) data from other AChE tolerated doses (Ref. 53). Second, the system. Because the relative sensitivity inhibiting pesticides show that direct BMDL10 from the mouth smacking and of the central and peripheral nervous measures of peripheral nervous system chewing in pregnant rats is similar to system varies among pesticides and the (e.g., lung, heart, and liver AChE) can be that being used by EPA for brain AChE children’s safety factor should account more sensitive than brain AChE in juveniles. The similarity of the CDPR for the most sensitive toxicity endpoint, inhibition; (2) a surrogate measure of the BMD in adults and EPA’s BMD in the Agency considers the availability of peripheral nervous system (RBC AChE) juveniles is striking because all of the data in both the central and peripheral is more sensitive in juvenile rats to available data show that pups are more nervous systems important in its safety carbofuran; and (3) clinical signs sensitive than adults to carbofuran factor evaluation. consistent with toxicity to the toxicity. This therefore suggests that As shown in Figure 1, above, there are peripheral nervous system were seen at behavioral effects and/or clinical signs several datasets that evaluate the effects very low doses, the Agency can not be may be occurring in juvenile animals at of carbofuran on the central nervous confident that assessing risk using brain lower doses, but which cannot be system (e.g., brain AChE inhibition) in AChE inhibition is protective of detected, in part due to the challenges
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with assessing clinical signs in juvenile to retain some portion of the adverse in itself, it is a surrogate for rats. As noted by the SAP, this presumptive 10X children’s safety inhibition in peripheral tissues. As ‘‘limitation reflects the limited range of factor, rather than remove it entirely. As such, RBC AChE inhibition provides an toxic signs detectable in very young explained above, EPA retained a portion indirect indication of adverse effects on pups (p. 54).’’ This provides further of the presumptive 10X children’s safety the nervous system (Id.). support that the lack of pup data at factor because of the absence of Petitioners raised many of the same lower doses is significant, because the sufficient data on PNS effects in issues raised in the objections in their Agency cannot fully evaluate the juveniles and the uncertainty created by comments on the proposed rule. For behavioral effects on juvenile animals. the limited data relevant to the PNS that example, they argued that, ‘‘as a matter Further support for the Agency’s showed greater sensitivity in juveniles. of science policy, brain AChE inhibition concern comes from other clinical In the previous subissue, Petitioners is the preferred endpoint over RBC reports of the effects of carbamate argued that in fact there is no AChE inhibition.’’ They also argued that poisoning in children. For example, uncertainty created by the lack of low no physiological function has been Lifshitz reported that all children dose RBC data and the finding of demonstrated for RBC, and RBC AChE presented with CNS symptoms (coma, sensitivity in the RBC AChE data inhibition is not itself an adverse effect. stupor), but CNS symptoms were because brain AChE data is protective of In the final rule, EPA responded to observed in only 54% and 23% of PNS effects. In this subissue, Petitioners each of their comments, but concluded children as reported by Zweiner and attempt to buttress their first argument that no information had been submitted Ginsburg (1988) and El-Naggar et al. by claiming that RBC AChE data are not to justify altering the Agency’s general 2009 (Refs. 91, 26). Peripheral an ‘‘appropriate surrogate’’ for PNS policy that reliance on RBC is muscarinic symptoms were the most effects, and should not have formed the appropriate as a surrogate for PNS commonly reported (73% and 100%) basis for retention of any portion of the effects in the absence of direct signs of toxicity in these latter two children’s safety factor. measurements in PNS tissues. reports. These markedly different Petitioners do not argue that RBC data ii. Denial of hearing request. This findings emphasize that conclusions are entirely irrelevant, but rather that subissue does not raise a dispute of cannot be unequivocally drawn from brain data are ‘‘preferred.’’ They raise material fact. There is no dispute only one study. several points in support of this regarding many of the facts raised in In addition, Petitioners’ own data contention; first, that ‘‘RBC AChE this objection: When data in the target show that effects can differ significantly inhibition data are only preferred for tissue are available, it is preferred over between high and low doses. In Chen, risk assessment purposes in two a surrogate. RBC AChE can be more for example, the data from Hoberman circumstances: (1) Where the PoD is set variable and less reliably measured at showed that at the lowest doses the using data from human studies where low response levels than brain AChE. levels of inhibition were higher in the only RBC data are available or (2) where RBC AChE inhibition can, in some PNS than in the brain, but at higher data from the relevant target tissues are cases, be more extensive than PNS doses, the levels were higher in the unavailable.’’ They allege that, despite AChE inhibition. Equally, there is no brain. the absence of carbofuran data in the dispute that no physiological function Thus, for a number of reasons, the PNS tissues, brain is preferred in this has been demonstrated for RBC, and Agency has concerns that children’s case because the brain is ‘‘target tissue’’ RBC AChE inhibition is not itself an PNS may be more sensitive to the effects from the nervous system, and because adverse effect. All of these points are of carbofuran than the CNS. This brain data are a ‘‘better predictor’’ of explicitly recognized in EPA’s concern is the basis for retention of a PNS effects than RBC. As further Cholinesterase policy and in the portion of the children’s safety factor. evidentiary support, they cite to tolerance revocation rulemaking record, The carbofuran RBC data in adult evidence from OP studies that RBC and relate purely to the ease or wisdom animals does not resolve this question. AChE can ‘‘in some cases’’ be inhibited of relying on these measures rather than There can be substantial differences in to a greater degree than either PNS or others, as opposed to the scientific response between pups and adults, and, brain AChE, and therefore reliance on invalidity of such data. The only point as noted, the data show clearly that RBC AChE data can overstate potential on which there is a dispute is, given that pups are more sensitive to the effects of PNS effects. They also argue that RBC there is no data in the target tissues of carbofuran. It is not unusual for juvenile AChE is more variable and less reliably the PNS, which data—brain or RBC—is rats, or indeed, for infants or young measured at low response levels, such ‘‘preferred.’’ The Petitioners expressly children, to be more sensitive to as 10% AChE inhibition. The evidence acknowledge this to be the issue: ‘‘There chemical exposures as metabolic in Exhibits 4 and 6 is also proffered in are other surrogate measures of PNS detoxification processes in the young support of this objection. AChE that could have been selected by are still developing. Because pups are i. Background. EPA’s well-established OPP, such as brain AChE’’ (Exhibit 4 at more sensitive than adult rats, data from policy when evaluating cholinesterase- 5). This is clearly a question of scientific pups provide the most relevant inhibiting compounds is to rely on data policy, since both EPA and the information for evaluating risk to infants in the target tissue where it is available Petitioners agree on the scientific and young children and are thus used (Ref. 76). As noted in the preceding validity and relevance of RBC AChE to derive the PoD. In addition, typically section, measures of AChE inhibition in inhibition data. As they expressly (and this is the case for carbofuran) the PNS are rarely collected for NMC acknowledged in their comments, the young children (ages 0–5) tend to be the pesticides. And in fact, there are no choice of which surrogate to use is a most exposed age groups because they carbofuran data measuring effects in matter of ‘‘science policy’’ (Ref. 18). tend to eat larger amounts of food per PNS tissues. But in the absence of target Indeed, Petitioners explicitly concede their body weight than do teenagers or tissue data, as a matter of science policy, the propriety of relying on RBC data adults. EPA typically uses RBC AChE ‘‘where data from the relevant target b. Objection/hearing request subissue: inhibition data as an indicator of tissues are unavailable, or when relying Reliance on RBC AChE inhibition data possible effects on AChE in the PNS for on human data, where RBC AChE as a surrogate for PNS effects. This number of reasons. (Ref. 76 at 32). inhibition data are the only data objection also challenges EPA’s decision Although RBC AChE inhibition is not available (Obj at 13). Hearings are not
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appropriate for debating questions of context of a statutory provision that (a) Exhibit 4. As discussed in the policy (40 CFR 178.32(b)(1)). expressly requires EPA to account for previous objection, this exhibit consists Nor does the proffered evidence missing data. EPA’s point in discussing of a report, along with published present any other issue that would the chlorpyrifos data—which Petitioners studies. The Report criticizes EPA for warrant a hearing. The evidence initially raised as relevant—was simply assuming that RBC AChE inhibition submitted in Exhibits 4 and 6 on this that it showed that because peripheral provides ‘‘a stronger and more point only relates to the question of tissues can be more sensitive than quantitative concordance with the whether brain data can sometimes central nervous system tissues, the sensitivity of AChE of the PNS to correspond more closely with PNS absence of data addressing carbofuran’s inhibition by carbofuran,’’ on the effects than RBC AChE data, rather than effects on the PNS is highly relevant. ground that EPA failed to cite to the question of whether the RBC data Whatever the chlorpyrifos data show evidence to support this inference are scientifically invalid. Or in other cannot resolve the extent of carbofuran’s (Exhibit 4 at 5). In the absence of such words, the submitted materials relate risks. As the Petitioners’ experts evidence, the report concludes that, only to the point that reliance on RBC themselves point out, ‘‘Even conceding ‘‘one cannot discount the plausibility data is unnecessarily conservative, that [EPA’s conclusion in the final rule that brain AChE may be a more because sometimes it overestimates the that peripheral tissues are often shown quantitative and representative potential PNS effects, rather than to the to be more sensitive than brain tissue surrogate measure of PNS sensitivity’’ factual question of whether RBC data following exposure to chlorpyrifos] may (Id). To support this allegation, the bears no relation whatsoever to PNS be true, it is still unclear how this report argues that the cited NMC data effects. Unless Petitioners can show that would be relevant to carbofuran * * *’’ show that the difference in sensitivity RBC AChE is not related to CNS effects (Exhibit 6 at 3). Accordingly, this between brain and RBC shown with generally or specifically for carbofuran, evidentiary submission fails to NMC chemicals is less than the or that brain AChE is protective of CNS demonstrate that a dispute exists on a differences seen with OP chemicals, effects generally or specifically for question of material fact. citing studies by Padilla et al. (Ref. 62) carbofuran, then the mere fact that RBC and McDaniel et al. (Ref. 54). In this AChE may be a conservative, or even Finally, their submission provides an regard, the Report actually misquotes very conservative, indicator of PNS inadequate basis on which to grant a McDaniel et al. The Report claims that effects is simply immaterial to the hearing; because evidence is not the paper concluded that there was a question of whether there are ‘‘reliable proffered on critical points, the stronger correlation between brain data’’ to justify removing the objection ultimately rests on allegation, AChE inhibition and motor activity. The presumptive 10X children’s safety factor speculation, and general denials (40 study actually concluded that there was in the absence of sufficient RBC AChE CFR 178.32(b)(2)). As discussed in little difference between brain AChE data. As shown in the discussion of preceding section, the majority of the inhibition and RBC AChE inhibitions subissue 1, the Petitioners’ evidence evidence comes from adult data, which (‘‘higher correlation for brain and motor does not demonstrate that reliance on are of limited relevance. Further, and activity compared to RBC were not juvenile brain data as a surrogate for more significantly, the evidence fails to significantly different.’’) (Ref. 54). In any effects in the juvenile PNS will demonstrate that brain data always—or event, the Report’s equivocal conclusion guarantee that the levels chosen on that even more frequently than not— that ‘‘one cannot discount the basis will be predictive of all PNS correlates more closely with PNS effects plausibility’’ that brain AChE might be effects from carbofuran, because the than RBC AChE data. Instead, the the most representative measure of PNS PNS effects occur only at the same or proffered evidence only demonstrates effect is, on its face, insufficient grounds higher doses than those that produce that whether brain or RBC data correlate to overcome the statutory presumption effects on the brain AChE—i.e., that the better with actual PNS effects can vary for retention of the additional 10X brain data ‘‘bound’’ all potential PNS depending on the chemical. This, children’s safety factor in the face of the effects. Nor, as discussed below, does therefore, cannot resolve the question as evidence of children’s additional any of Petitioners’ evidence support a to whether, in the case of carbofuran, sensitivity to carbofuran, and the lack of conclusion that RBC AChE is unrelated brain AChE data will necessarily carbofuran data in PNS tissues or in a to PNS effects. correspond more closely with the PNS. surrogate for such tissues, RBC AChE. Indeed, much of the evidence in the Finally, as also discussed in the Chen et al. (Ref. 17), which was Exhibit 4 and 6 Reports is ultimately an preceding section, Petitioners’ argument discussed at length in the earlier irrelevance, and thus fails to present a is internally inconsistent, because they objection, evaluated whether plasma or material factual dispute. Instead of rely on carbofuran adult RBC AChE data RBC AChE should be used to establish focusing the stated objection—RBC to support their argument that exclusive a regulatory endpoint; it did not AChE is inappropriate marker for CNS reliance on the brain data will be evaluate whether brain AChE would be effects—the Reports attempt to link protective of potential PNS effects in an appropriate surrogate for PNS effects. EPA’s children’s safety factor decision pups. No hearing is appropriate where It is true that the authors conclude that to findings concerning chlorpyrifos the proffered evidence fails to prove the ‘‘[i]nhibition of RBC AChE activity is (Exhibit 4 at 4). In fact, a fair portion of points for which it is offered, or offers consistently exhibited at lower dosages the Report in Exhibit 6 is dedicated to merely equivocal support (See, 73 FR of chlorpyrifos than those required to a rebuttal of EPA’s conclusion that the 42705 (July 23, 2008) (hearing denied result in clinical symptoms of OP majority of the more recent and more because published articles focus on an toxicity, or alterations in cognitive relevant chlorpyrifos evidence did not issue not applicable to the facts of the functional responses.’’ However, since support Petitioners’ contention. EPA, case at hand); 68 FR 46405–46406 the study authors ultimately concluded however, has been clear throughout the (August 5, 2003) (a hearing was denied rulemaking that the basis for retention that, ‘‘inhibition of RBC AChE activity because the cited studies only contained of a children’s safety factor has been the is an appropriate surrogate for equivocal statements)). absence of carbofuran data to determine measurement of chlorpyrifos exposure the levels of exposure that will be A detailed examination of Petitioners’ and provides a conservative endpoint protective of children’s PNS, in the evidence follows below: for establishing appropriate margins of
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safety for both adults and infants,’’ it is to support these claims. For example, here is straightforward. As a biomarker difficult to see how this could be argued the Report addresses EPA’s rejection of of exposure, blood AChE inhibition can to provide unequivocal support for the Bretaud study in goldfish on the be correlated with the extent of Petitioners’ objections. grounds that the ‘‘distribution of exposure. There is often a direct Exhibit 6. This exhibit consists of a carbofuran across fish and mammalian relationship between a greater report by Lucio Costa, PhD, entitled, tissues may be quite different,’’ by magnitude of exposure and an increase ‘‘Expert Report: Carbofuran’s FQPA criticizing EPA for failing to provide in incidence and severity of clinical Safety Factor and Interspecies ‘‘evidence or a citation to support this signs and symptoms as well as blood Uncertainty Factor,’’ as well as point’’ (Exhibit 6 at 1). But they cite to AChE inhibition. In other words, the published literature studies. The report nothing demonstrating the similarity of greater the exposure, the greater the discussed the results of several fish and mammalian tissues or amount of AChE inhibition that will be published studies that they claim otherwise supporting their proposed present in the blood and the greater the demonstrate that ‘‘where available, extrapolation across taxa; at this stage of potential for an adverse effect to occur. brain AChE inhibition data provide a the administrative process the RBC measures of AChE inhibition also superior surrogate’’ to RBC data because obligation is on the Petitioners to come provide: (1) Pharmacokinetic evidence ‘‘in some cases RBC AChE may forward with evidence to call EPA’s of absorption of the pesticide and/or its overestimate PNS AChE inhibition, conclusions into question. See, 73 FR active metabolite(s) into the while in other cases * * * RBC AChE 42683, 42706, July 23, 2008 (‘‘NRDC bloodstream and systemic circulation; inhibition may underestimate actual does no more than state ‘we are aware and (2) pharmacodynamic evidence of AChE inhibition in the PNS.’’ In support of no statistical test’ which would binding to AChE, the neural form of the of this allegation, the report references support EPA’s use of the Gledhill data. target enzyme. Because the interaction data from several studies conducted As EPA’s regulations make clear, a mere with AChE is widely accepted as a key with chlorpyrifos and disulfoton, both ‘denial’ of an EPA position is not event of the mechanism of toxicity for OP pesticides, and a single study with enough to satisfy the standard for anticholinesterase pesticides, inhibition propoxur, an NMC pesticide (Refs. 16, granting a hearing.’’); 53 FR 53176, of this AChE in the blood creates the 19, 20, 21, 41, 52, 61, 64, and 71). 53199, December 10, 1982 (‘‘Rather than presumption that a chemical also is According to the Report, these studies presenting evidence, [the objector] causing inhibition of neural AChE. generally show that there was similar or asserts that FDA did not adequately Chemicals are absorbed into the blood greater AChE inhibition in brain than in justify its conclusions. Such an and transported to the PNS. the PNS tissues of heart, ileum, or the assertion will not justify a hearing.’’). Pharmacokinetically, the blood diaphragm, which Petitioners claim The report also attempts to dismiss compartment and the PNS are ‘‘outside proves that reliance on carbofuran pup EPA’s conclusions by complaining that of’’ the central nervous system, i.e., brain AChE inhibition data is more EPA’s assessment fails to include ‘‘any separated from the CNS by the blood- predictive of all effects in the PNS. The analysis of the relationship between brain barrier. Thus, RBC measures of exhibit also references a human incident RBC AChE and PNS AChE.’’ This also, AChE activity are viewed as a better study (Ref. 50) of carbamate poisoning cannot justify a hearing. As has been surrogate for the effects on AChE in the in early childhood and in adults, previously noted, FMC, who bears the peripheral nervous system than are claiming that, ‘‘Lifshitz * * * showed statutory burden for producing such enzyme changes in the CNS. Because that signs of adverse effects in the CNS, data, has failed to provide data in the data on AChE inhibition in the PNS rather than PNS, prevailed in young PNS that would allow EPA to make the have rarely been gathered in animals, children at the low dose levels covered suggested comparison (See, 73 FR blood AChE inhibition measures are by the paper.’’ In its denial of the hearing request on 42683, 42699, July 23, 2008 (hearing generally the only information available the previous issue, EPA examined the denied where NRDC made no to assess the potential of chemicals to results of the studies in this exhibit at evidentiary proffer supporting its claim inhibit AChE in the peripheral nervous length, and demonstrated that the that each of the factors cited in EPA’s system. results of the studies failed to support risk assessment ‘‘poses a serious risk of Finally, based on the record, FMC a conclusion that brain data correlate understating the risks’’); 70 FR 21619, seemingly intended in the past for RBC more closely to PNS effects than RBC April 27, 2005 (objector questioned AChE to be used as a surrogate for data. Indeed, in most of these studies, exposure assessment and studies relied peripheral AChE inhibition. In 2005, brain AChE inhibition poorly reflected on for assessment; hearing denied FMC submitted a time course study the AChE inhibition in PNS tissues. For because no information presented); 72 with plasma and RBC AChE inhibition example, the Carr et al. study results, FR 39557, 39560, July 19, 2007 following acute exposure to carbofuran reproduced in Table 1 of Exhibit 6, (‘‘Although Public Citizen alleged that in adult rats. The title of this study is showed that for PND 10, 16, and 20 rat the studies that FDA evaluated do not ‘‘The toxicokinetics of peripheral pups, the heart tissue had the greatest support the safety of x-rays of 10 MeV cholinesterase inhibition from orally levels of inhibition, and that PND 16 or lower used for inspection of cargo administered carbofuran in adult male and 20 rat pups had greater levels of containers that may contain food, Public and female CD rats (Ref. 5).’’ Although inhibition in lung tissue than in the Citizen did not present any evidence this study is entitled ‘‘peripheral brain (Ref. 16 at 3). Further, since the that would have led to a different cholinesterase inhibition,’’ there are no study was conducted with serum, which conclusion concerning the safety of the actual measures of peripheral toxicity contains no RBC, it is unclear how this subject additive.’’). (e.g., liver, lung, heart). Instead, RBC study could prove that brain data are a iii. Denial of Objection. EPA’s well- and plasma ChEs are the only measures better indicator of PNS effects than RBC established policy when evaluating included. That report states that data. blood cholinesterase inhibition is to use ‘‘carbofuran reversibly inhibits The remainder of the report consists RBC AChE data as an indicator of cholinesterase activity by binding to of criticisms of EPA’s conclusions, and possible effects on AChE in the PNS; acetycholinesterase in red blood cells contentions that EPA was inconsistent, EPA adopted this policy for a number of * * * Carbamylation of cholinesterase without citation to biological evidence reasons (Ref. 76 at 32). EPA’s reasoning after the association of carbofuran leads
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to an accumulation of acetylcholine and was addressed was a sentence that is clear from both the proposed and inhibition of nerve function at the states, ‘‘One issue raised at the FIFRA final rules that the results of this study neuronal and neuromuscular synapse.’’ SAP meeting was whether ‘lip merely supplemented the Agency’s Based on this statement, FMC assumed smacking’ observed in the adult females bases for concern (73 FR 44871–44872; at the time of conducting and in the developmental toxicity study 74 FR 23073–23075). The Petitioners’ submitting this study that measures of were the result of PNS or CNS AChE complaint that the effects occurred at RBC AChE were relevant for predicting inhibition’’ (Ref. 18 at 82). In a footnote dose levels three times higher than PoD neurotoxicity and for use in risk to this allegation, the Petitioners stated and therefore do not quantitatively assessment. For all of these reasons, the ‘‘Moreover, it is impossible to tell from support the 4X children’s safety factor is Petitioners’ objection is denied. the study data whether this ‘‘lip equally immaterial. The record is clear c. Objection/hearing request subissue: smacking’’ was a PNS or a CNS effect.’’ that EPA relied on comparisons between ‘‘Lip-smacking’’ as CNS effect. (Ref. 18 at 82). The Petitioners’ the BMD50 estimated for pup brain and Petitioners object that EPA’s evidence of comments focused instead on the RBC AChE inhibition to derive the 4X ‘‘lip smacking’’ in a carbofuran adult contention that the study was irrelevant (73 FR 44871–44872; 74 FR 23073– developmental rat study does not because the dose levels in the study 23075). A hearing can only be based on support concern for potential PNS were higher than the dose levels at a genuine issue of disputed fact. Where effects because lip smacking is more which EPA was regulating for AChE a party’s factual allegations are properly correlated to CNS, rather than inhibition (Ref. 18 at 82). contradicted by the record, there is no PNS inhibition. In support, the EPA did not respond to the genuine dispute (40 CFR 178.32(b)(1)) Petitioners proffer testimony that relies Petitioners’ description of the (See, 73 FR 42683, 42701 July 23, 2008; on four published studies, none of discussion at the SAP, since it correctly 57 FR 6667, 6672, February 27, 1992) which was conducted with carbofuran. characterized the discussion. However (‘‘A hearing must be based on reliable The papers describe pharmacological EPA responded fully to the Petitioners’ evidence, not on mere allegations or on and physiological analyses of the bases comment regarding the dose levels in information that is inaccurate and of ‘‘purposeless chewing movements’’, the final rule and response to contradicted by the record.’’). ‘‘chewing jaw movements’’, ‘‘chewing comments. iii. Denial of objection. The motions and tongue protrusions’’, and ii. Denial of hearing request. There carbofuran developmental study does ‘‘tongue protrusion and gaping’’ seen in can be no legitimate argument that this not definitively resolve whether the rats dosed with either cholinergic or comment raised the issue in sufficient dopaminergic drugs. detail to allow Petitioners to object that effects described were the product of i. Background. In the proposed rule, ‘‘lip smacking’’ is more properly PNS or CNS AChE inhibition; because in addition to the data in pups showing correlated with CNS inhibition, and to only RBC AChE inhibition data were frank PNS effects (tremors), EPA supplement the objection with the collected it is not possible to determine discussed the results of another published literature studies they cite the degree of CNS inhibition. However, carbofuran study that appeared to be a here. See, e.g., Forest Guardians v. US as the Petitioners acknowledge, chewing possible consequence of PNS inhibition, Forest Service, 495 F.3d 1162, 1170– or oral fasciculations, which are the to provide further explanation of the 1172 (10th Cir. 2007) (Claim held movements EPA described at the SAP basis for EPA’s concern that carbofuran waived where comments ‘‘failed to meeting and in the proposed and final could cause adverse PNS effects. The present its claims in sufficient detail to rules, have often been reported as an proposed rule stated that ‘‘[t]here is allow the agency to rectify the alleged early sign of toxicity produced by indication in a toxicity study where violation’’); National Association of carbamates and OPs in rats (Exhibit 5 at pregnant rats were exposed to Manufacturers v. US DOI, 134 F.3d 2). Petitioners also acknowledge that carbofuran that effects on the PNS are of 1095, 1111 (DC Cir. 1998) (‘‘We decline ‘‘oral fasciculations’’ are indeed a concern; specifically, chewing motions to find that scattered references to the peripheral neuromotor response (Id.) or mouth smacking was observed in a services concept in a voluminous record (‘‘some of the toxicity is peripherally clear dose-response pattern immediately addressing myriad complex technical mediated or an effect on the PNS (for following dosing each day’’ (73 FR and policy matters suffices to provide example, muscle fasiculations and 44873, July 31, 2008). EPA explained an agency like DOI with a ‘fair tremors are due to inhibition of AChE at that the California Department of opportunity’ to pass on the issue.’’) For the motor endplate of the muscle)’’). Pesticide Regulation calculated a BMD05 the reasons discussed in Unit VI.C, EPA Nevertheless, Petitioners attempt to and BMDL05 of 0.02 and 0.01 mg/kg/ considers the objection and evidence confuse the issue by providing several day, and established the acute PoD untimely, and therefore waived. As different descriptions of oral based on this study. The Agency also such, this objection does not warrant a movements, from lip-smacking to mouth explained that ‘‘[t]hese BMD estimates hearing. smacking to mouth movements to are notable as they are close to the But in any event, this issue is not chewing movements, and claiming that values EPA has calculated for brain material. EPA’s decision to retain a 4X it is clear that these are all CNS effects. AChE inhibition and being used as the children’s safety factor did not rest As an initial matter, it is unclear PoD for extrapolating risk to children’’ exclusively, or even significantly—on whether all of the study authors in (73 FR 44873, July 31, 2008). The the effects observed in this Petitioners’ cited literature are referring similarities of the BMDs in adult and developmental study. Rather, EPA to the same phenomenon. It is therefore juvenile rats suggests that toxicity may retained the children’s safety factor unclear whether the oral movements be occurring in juvenile animals which based on the lack of data in the PNS from the carbofuran developmental cannot be detected due to the challenges and/or a surrogate at the low end of the study (which EPA described as ‘‘lip- with assessing clinical signs in juvenile response curve, and the fact that the smacking’’ and ‘‘fasiculations’’) are the rats. available pup RBC data at higher doses same responses described as ‘‘tongue The Petitioners did not raise the affirmatively indicate that the PNS protrusion,’’ ‘‘gaping,’’ ‘‘yawning,’’ and allegation contained in their objections appears to be significantly more ‘‘chewing movements’’ in the as part of the Petitioners’ comments. sensitive than the CNS (73 FR 44871– pharmacology papers Petitioners The context in which ‘‘lip smacking’’ 44872; 74 FR 23073–23075). Indeed, it reference. It is not unlikely that all of
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the different papers refer to somewhat solutions, clinical observations, final rule, and by ignoring the EPA’s different actions; Rupniak et al. (Ref. 68) standardization of brain and RBC AChE final rule on this subissue, Petitioners were able to produce ‘‘chewing jaw results in terms of amount per unit of have failed to lodge a relevant objection. movements’’ by chronic treatment with protein, and quality assurance records Both EPA and FDA precedent make haloperidol, a dopaminergic receptor of inspections for the carbofuran portion clear that when the agency substantively antagonist, which suggests that the of the study. However, no more specific responds to comments on the proposal, movements studied in that paper are not explanation was provided as how this the commenter may only keep that issue purely cholinergic. The fact that purportedly missing data rendered the alive in its objections by addressing the anticholinergics could block the data scientifically deficient. EPA agency’s substantive response. See, e.g., haloperidol-induced dopaminergic responded in full to these allegations in 73 FR 42701 (denying hearing because movements shows that this is not a the final rule and response to comments NRDC merely repeated its assertion that straightforward physiological response document. the study was not representative from dealing only with the cholinergic EPA’s regulations at 40 CFR part 160 its petition, rather than objecting to the system. For the same reason, this calls establish a set of principles that basis EPA asserted in its petition denial into question the contention that the provides a framework within which for concluding that the study was effects are exclusively CNS-related. laboratory studies are planned, representative). Similarly, the claim that the ‘‘the performed, monitored, recorded, Indeed, this entire objection is not masticatory response’’ is clearly a CNS reported, and archived. GLP helps material. The EPA–ORD data are the effect is equally misleading and assure EPA that the data submitted are only valid pup RBC data using inaccurate. The report in Exhbit 5 a true reflection of the results obtained carbofuran; in the absence of these data, claims that ‘‘[t]he masticatory response during the study and can therefore be EPA would have no data that would is considered a preliminary index of relied upon when making risk/safety provide relevant information on convulsive activity and convulsions assessments. The regulations are carbofuran’s effects on children’s PNS. have been demonstrated to be caused by applicable only to studies that support, Under such circumstances, EPA would changes in brain chemistry.’’ None of or are intended to support applications be required to retain the statutory the papers the Petitioners cited describe for ‘‘research or marketing permits’’ for default 10X, because there would be no this ‘‘masticatory response’’ in that way. pesticides regulated under FIFRA (40 ‘‘reliable data’’ on which to base any Instead, those papers all state that this CFR 160.1(a)). other factor. ii. Denial of hearing request. On response is seen at relatively low doses iii. Denial of objection. The mere fact of these anticholinesterases. By way of several grounds, a hearing on this that a study is not conducted in contrast, convulsions are seen at high subissue is not warranted. First, this accordance with EPA’s GLP regulations doses. The Exhibit also implies that the objection fails to identify a dispute of does not mean that the study is ‘‘masticatory’’ response and convulsions material fact. There is no dispute that scientifically invalid, or that EPA is are a continuum of the same the EPA–ORD studies were not prohibited from considering the study. phenomemon; however EPA is aware of conducted in strict accordance with The GLP regulations do not apply to no scientific support for this claim, and EPA’s GLP regulations. Nor have EPA–ORD generated data, but rather to Petitioners have provided none. Petitioners identified a substantive flaw Petitioners’ objection on this issue is in those studies that they believe studies conducted to ‘‘support therefore denied. resulted from the lack of compliance applications for research or marketing The Exhibit also implies that the with the regulations, or otherwise permits for pesticide products’’ (40 CFR ‘‘masticatory’’ response and convulsions challenged the scientific validity of 160.1(a)). Moreover, the regulations are a continuum of the same those studies. Thus, the only issue establish general practices; they do not phenomemon; however EPA is aware of presented is whether EPA should rely identify the only good laboratory no scientific support for this claim, and on otherwise scientifically valid studies practices that will result in scientifically Petitioners have provided none. that were not conducted in accordance valid data. Other laboratory protocols, d. Objection/hearing request subissue: with its GLP regulations. This is clearly such as that used by EPA–ORD are EPA’s analysis does not rely on Good a legal or policy issue. Hearings are not equally valid. In recognition of this fact Laboratory Practice (GLP)-compliant appropriate on such issues; issues of the regulations do not prohibit EPA studies. Petitioners object that EPA’s fact, not of law or policy are required to from considering studies that were not reliance on the ORD data is problematic justify a hearing (40 CFR 178.32(b)(1)). conducted in accordance with EPA’s because the data were not conducted in A further defect is that Petitioners GLP regulations, but merely provide accordance with EPA’s GLP regulations have submitted no evidence on this that EPA may refuse to consider such at 40 CFR part 160. point. In fact, this claim consists of studies to be ‘‘reliable’’ (40 CFR i. Background. The only data available nothing more than the bare statement 160.17(a)). on the effects of carbofuran on the pup that EPA’s analysis does not rely on Nor does compliance with EPA’s GLP PNS are RBC AChE inhibition data from GLP-compliant studies. A hearing will regulations guarantee the validity of the two studies conducted by EPA–ORD. not be granted on ‘‘mere allegations’’ or study’s results. The RBC data from These data unequivocally show that pup ‘‘general contentions’’ (40 CFR FMC’s carbofuran CCA studies, which RBC AChE is more sensitive than pup 178.32(b)(2)). To the extent the were conducted in accordance with brain AChE. EPA also used these data in Petitioners are relying on the EPA’s GLP regulations, were its calculations supporting the 4X information submitted as part of their unanimously determined to be children’s safety factor. In their comments on the proposed rule, this scientifically invalid by the FIFRA SAP comments on the proposed rule, does not cure the defect, since no (Ref. 36). Petitioners alleged that, ‘‘the Moser substantiating information or other Any claim that the conduct of the study may not meet minimum criteria evidence was presented in support of EPA–ORD studies raised questions as to for scientific acceptability.’’ They based their comments. Nor can simple their scientific validity is equally this on a claim that critical data were reiteration of a comment made on the baseless. EPA’s ORD data were reviewed unavailable for this study, including: A proposed rule justify a hearing. EPA by the FIFRA SAP, which concluded complete protocol, analysis of dosing responded to these comments in the that, ‘‘EPA–ORD has provided excellent
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data regarding RBC AChE inhibition by ii. Denial of hearing request. A surrogate tissue (i.e., RBC). EPA’s carbofuran’’ (Ref. 36 at 55). hearing is not appropriate on this hazard identification for carbaryl states: objection because it raises a legal or As EPA explained in response to the ‘‘Although the RBC BMDL10 for the more Petitioners’ comments, all of the policy claim, rather than a dispute as to sensitive PND 11 rat is numerically the information the Petitioners claimed was a material issue of fact. The claim that lowest (0.8 mg/kg) of the two compartments, missing had been previously made EPA acted inconsistently in assessing biologically the RBC BMDL10 is similar to the publically available as part of the SAP different pesticide chemicals is purely a brain BMDL10 (1.1 mg/kg). Since the brain is review of the carbofuran NOIC, and was legal issue. There is no factual dispute the target tissue for the NMCs, and the brain provided again in response to FMC’s that EPA established a children’s safety BMDL10 1.1 mg/kg is also protective of the surrogate and often more variable RBC ChE FOIA request. A complete study factor of 1X for carbaryl, and a safety measurements (BMDL 0.8 mg/kg), then the factor of 4X for carbofuran. The only 10 protocol, as well as a report of the brain BMDL10 of 1.1 mg/kg is the appropriate quality assurance (QA), technical, and dispute concerns whether EPA’s basis PoD for both children and adults in the data reviews of the study, were for distinguishing between the two is carbaryl risk assessment (Ref. 82).’’ available, which demonstrated that the reasonable, and this is a legal claim, on Thus, for carbaryl, biologically the RBC procedures and documentation are in which a hearing is not appropriate (40 and brain AChE inhibition were accordance with the National Health CFR 178.32(b)(1)). basically equivalent where brain AChE and Environmental Effects Laboratory In addition, the Petitioners make no inhibition is a direct measure in a target (NHEERL)/ORD Quality Assurance claim other than to reiterate the tissue and RBC AChE inhibition is used Management Plan. Concerning allegation made in their comments on as a surrogate for the peripheral nervous standardization of brain and RBC AChE the proposed rule, that EPA’s system. This is quite different from the in terms of protein concentration, the assessment of carbofuran is inconsistent situation with carbofuran where a Agency notes that this analysis has not with its assessment of carbaryl. significant difference was noted been performed or provided in all the Consequently, Petitioners’ objection on between RBC and brain AChE studies on the record, including those this subissue is irrelevant, and therefore inhibition, showing that RBC AChE sponsored by FMC. However, in the immaterial, with regard to EPA’s final inhibition (used as a surrogate for the Moser study (Ref. 56), the AChE activity tolerance revocation regulation because PNS) is more sensitive. was standardized in terms of tissue Petitioners ignored EPA’s extensive The approach used for carbaryl—i.e., weight per ml, so the amount of protein analysis of this issue in the final rule relying on the central estimate for was consistent across samples, which is and refiled their comments on the purposes of comparison across age an acceptable and widely used practice. proposal as if EPA’s determination in groups, and using biological Further, abnormal (or ‘‘clinical’’) the final rule did not exist. By ignoring compartments and the lower limits for observations were recorded when they the EPA’s final rule on this subissue, use as PoDs—is being used by EPA in occurred, although the animals could Petitioners have failed to lodge a its carbofuran risk assessment. In not be watched while they were in the relevant objection. Nor have they addition, this approach was used in the motor activity chambers. Finally, the proffered any evidence in support of NMC cumulative risk assessments registrant is correct that the dosing this claim. When EPA responds to a (CRA) and single chemical risk solutions for the comparative ChE study comment in the final rule, mere assessments for multiple OPs. Thus, the were not analyzed, but ORD performed reiteration of the comment in objections Agency is, in fact, being consistent in its this analysis for the adult studies in does not present a live controversy hazard identifications among the AChE- McDaniel et al. (Ref. 54), and the unless the objector proffers some inhibiting pesticides. preparation and stability of the evidence calling EPA’s objection into With regard to the carbaryl children’s carbofuran samples were confirmed question (See, e.g., 73 FR 42700–42701). safety factor, the available brain and therein. For these reasons, this objection iii. Denial of objection. Carbaryl was RBC dose-response data in PND11 pups is denied. evaluated no differently than include data from the lower end of the e. Objection/hearing request subissue: carbofuran. The different children’s dose-response curves. ORD’s Consistency of EPA’s approach to safety factors applied to each chemical comparative ChE data with carbaryl deriving the carbofuran children’s safety reflects the differences in the chemicals show that at the lowest dose at or near factor—i. Background. The Petitioners themselves, as reflected by the data. 20% inhibition in brain and RBC AChE argue that EPA’s approach to deriving It is typical EPA practice to use the were observed. Although not ideal, the carbofuran’s children’s safety factor is central estimate on the BMD as an carbaryl data provide information closer inconsistent with that Agency’s appropriate measure for comparing to the benchmark response of 10%, and approach in deriving the safety factors chemical potency and the lower limit on therefore allow for a reasonable for other NMC chemicals. Specifically, the central estimate (i.e., BMDL) as an estimation of the BMD10 and BMDL10. they point to carbaryl, which had a appropriate measure for extrapolating This is distinctly different from ORD’s safety factor of 1X. risk. In the case of carbaryl, the data with carbofuran in PND11 and Petitioners raised this issue in their Petitioners inappropriately focused on PND17 pups where the 50% or greater comments on the proposed rule. In the the BMDL10, instead of the BMD10. The RBC AChE inhibition was observed at final rule, EPA explained at length, the more appropriate comparison is the lowest dose. Accordingly, the basis for its conclusion that the between the BMD10; the carbaryl brain objection is denied. available data using carbaryl, provided BMD10 is 1.46 mg/kg compared with the 2. EPA’s Mathematical Modeling by the carbaryl registrant, supported a RBC BMD10 of 1.11 mg/kg. As such, the Underlying the Calculation of a 4X finding that a 1X children’s safety factor brain to RBC ratio is 1.3X. Therefore, for Children’s Safety Factor. Petitioners would be ‘‘safe’’ (74 FR 23058 and Ref. carbaryl, the brain and RBC AChE data argue that EPA committed numerous 85). EPA explained that the different are similarly sensitive. When the tissues errors in calculating the 4X children’s safety factors established for carbaryl are similarly sensitive, the Agency safety factor. First, Petitioners allege and carbofuran resulted from prefers to use data from the target tissue that, even assuming that RBC values are differences in the chemicals themselves, (i.e., central or peripheral nervous relevant, EPA’s conclusion that the as reflected by the available data (Id). system) rather than data from a RBC-related effects in the relevant
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studies were four times more sensitive EPA also compared the BMD50 ratios consumption patterns were likely.’’); than brain effects is not mathematically for PND17 pups (who are slightly less accord Community Nutrition Institute v. supportable. Referencing statistical sensitive than 11-day olds) in the EPA– Novitch, 773 F.2d 1356, 1363 (DC Cir. analyses performed by a contractor, they ORD study, to confirm that the observed 1985) (‘‘Mere differences in the weight claim that ‘‘[a]t most, the data support differences in sensitivity between RBC or credence given to particular scientific a 2X safety factor, based on actual and brain were not unique to the PND11 studies * * * are insufficient [to show difference between brain and RBC data. The result of EPA’s modeling a material issue of fact for a hearing].’’)). 13 (ranging between 1 and 1.9).’’ showed a BMD50 ratio of 3.3 between Second, Petitioners’ hearing request is Second, the Petitioners claim that brain and RBC in the PND17 pups. inadequate because they do not object to there are several technical errors in the In their comments on the proposed the basis EPA asserted in the final rule way EPA conducted the statistical rule, Petitioners presented essentially for rejecting this approach. Specifically, modeling that formed the quantitative the same arguments raised in this Petitioners do not challenge EPA’s support for the 4X children’s safety objection. They argued that a more conclusion that their suggested factor. They also object that the plausible and straightforward approach approach is fundamentally flawed in mathematical assumptions underlying would be to compare the RBC and brain several regards, nor proffer evidence in EPA’s modeling are not justified and fail AChE levels at the same time in the support of that challenge. Petitioners to support the 4X children’s safety same rat when these rats are exposed to also do not challenge EPA’s analyses, factor. In this regard, they allege that carbofuran. The comments claimed that showing that the results of their EPA’s children’s safety factor was based a statistical evaluation of the suggested approach are in fact on calculations that (i) are not based on experimental data on AChE inhibitions consistent with EPA’s conclusions. As a ‘‘within animal comparisons;’’ (ii) have in RBC and brain in rats due to consequence, Petitioners’ objections are been applied incorrectly and carbofuran exposure had been irrelevant, and therefore immaterial, inconsistently to the data, which performed by Sielken & Associates, with regard to EPA’s final tolerance exaggerated the difference; (iii) overstate which showed that the percentage revocation regulation. The statute, the evidence for higher relative RBC inhibition of RBC AChE in a rat is however, requires that objections be sensitivity; and (iv) treated carbofuran almost the same as the percentage filed on the final rule not the proposal. inconsistently as compared to other inhibition of brain AChE in the rat. By ignoring the EPA’s final rule on this NMCs. They claim that by removing the Although the results of the statistical subissue, Petitioners have failed to inconsistencies from EPA’s data, the analyses were summarized in the lodge a relevant objection. Prior FDA data yield a brain/RBC ratio of 1.3, comments, the underlying analyses decisions under its regulations are which confirms Petitioners’ approach. were not submitted. instructive here. Objections and hearing In the final rule, EPA provided a These five allegations are addressed requests were filed in response to a food detailed explanation of its rationale for separately below. additive regulation covering the rejecting the Petitioners’ approach (74 In support of these claims, the irradiation of poultry. (62 FR 64102 FR 23055; Ref. 85). Petitioners offer allegations on the (December 3, 1997)). The objector ii. Denial of hearing request. EPA is points above, referencing two argued that the addition of an anti- denying Petitioners’ request for a memoranda from Drs. R. Sielken and C. oxidant (ethoxyquin) to irradiated hearing on this objection for two Valdez-Flores (Exhibits 7, 8, 9) that chicken prior to the chicken’s use in reasons. First, as in its comments, generally describe and summarize the animal feeding studies compromised the Petitioners failed to submit the analyses and modeling they conducted. studies because the ethoxyquin would underlying modeling conducted in The full analyses underlying these have decreased the level of lipid support of its assertions. Petitioners’ memoranda were not included with the peroxides in the chicken to levels found consultant merely asserts that the objections. in chicken that had not been irradiated. results are as presented in his The FDA noted, however, that it had a. Objection/Hearing Request Subissue: summarized testimony. In the absence considered the question of ethoxyquin’s Use of Within-Animal Brain to RBC of the underlying scientific analyses, effect on lipid peroxide levels in the Inhibition Comparisons To Derive the these are effectively no more than mere final rule and determined that while Children’s Safety Factor allegations or general contentions. ethoxyquin can retard the normal Hearings will not be granted on this i. Background. In the proposed rule, oxidation of chicken fat to peroxides, basis alone. (40 CFR 178.32(b)(2); see EPA explained its approach to deriving ethoxyquin cannot reverse oxidation also 73 FR 42702 (July 23, an alternate to the default 10X that has already occurred. FDA denied 2008)(denying NRDC’s hearing request children’s safety factor. This safety the hearing request reasoning that on objection that EPA’s risk assessment factor was calculated using the ratio of because the objector did ‘‘not dispute was inadequate because EPA lacked RBC and brain AChE inhibition, using FDA’s explanation in the final rule as to data on how pest strips were used in the data on administered dose for the why addition of ethoxyquin did not their homes, because ‘‘NRDC provided PND11 animals from the EPA–ORD compromise the CIVO studies, and no factual information to support its studies and the FMC studies combined. provided no information that would claim’’); 68 FR 46403, 46406–46407 In other words, EPA estimated the have altered the agency’s conclusion on (August 5, 2003) (FDA denied a hearing BMD this issue * * * there is no factual issue 50 for PND11 animals for RBC and involving a challenge to FDA’s reliance that can be resolved by available and brain from each quality study and used on consumption pattern data because specifically identified reliable the ratio from the combined analysis, the objector ‘‘did not present any evidence’’ (62 FR 64105). See also 53 FR resulting in a BMD50 ratio of 4.1X. EPA specific information to dispute P & G’s 53176, 53191 (December 30, 1988) (FDA estimated the RBC to brain potency ratio consumption pattern data; instead, denied a hearing request noting that using EPA’s data for RBC (the only [objector] simply asserted that other reliable RBC data in PND11 animals for given FDA’s prior conclusion that the carbofuran) and all available data in 13 EPA corrected a technical error identified in studies relied upon by the objector were PND11 animals for brain. EPA’s Petitioners’ comments, which resulted in a revised unreliable, the ‘‘burden shifted to [the approach yields a ratio of about 4 fold. ratio of 2.6X, for the final rule. objector] to maintain the viability of its
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objection by proffering some Petitioners’ suggested reliance purely on the BMD50 s for brain and blood relied information that called into question the the average degree of inhibition on an assumption that the magnitude of agency’s conclusion on this matter.’’)). provides no information that the difference between RBC and brain Similarly, here, Petitioners have not corresponds to a practical basis for AChE inhibition is constant across dose. challenged the basis EPA asserted for regulation. In other words, EPA assumed that the rejecting their suggested within-animal Finally, the range of ratios of effects RBC and brain AChE dose curves are analyses, nor have they proffered any that the Petitioners propose as an parallel, even though there are no data information calling into question EPA’s alternative is consistent with range of to test this assumption (73 FR 44873). In conclusion. potencies that EPA has calculated at their comments, the Petitioners iii. Denial of objection. EPA notes that these higher doses, so the Petitioners’ criticized EPA for this assumption, and the Petitioners recommended this results do not ultimately contradict recommended using ‘‘within animal approach of comparing the degree of EPA’s assessment, which is intended to comparisons’’ to avoid having to make inhibition for each animal as part of account for the effects at lower doses. this assumption. In the final rule, EPA their presentation to the carbofuran Briefly, if the dose-responses for RBC explained that its decision to rely on SAP. EPA also addressed this approach, and brain inhibition were linear, ratios comparisons of BMD50 s rather than comparing RBC to brain in the same of inhibition would equal ratios of BMD10 s was because the RBC data for animals, at the SAP and in the BMDs. However, these dose-responses 10% inhibition levels was insufficient responses to the SAP report (Ref. 83). It are not at all linear; rather the available to allow the Agency to generate the is notable that the SAP did not endorse data demonstrate that brain and blood necessary estimates. EPA agreed that the this approach (Id.). dose-responses have somewhat different dose-response curves were not parallel EPA’s analyses of the Petitioners’ shapes. Thus, estimates of relative at these lower doses, (i.e., that the approach identified several significant effects at particular, relatively high, relationship between BMD50 s and deficiencies. First, the comparison doses will not determine the estimated BMD10 s was not linear) but that EPA suggested by the Petitioners would ratios at lower doses. This is because the lacked any data that would allow it to require that EPA ignore existing data. dose-response curves begin to level off make any other assumption. EPA This is because only EPA’s study of as they reach maximal inhibition (i.e., nevertheless rejected the Petitioners’ PND 11 animals contains both brain and no more inhibition is possible), so, at suggested approach of relying on RBC data, so the comparisons suggested high doses, there is almost no difference within-animal comparisons, because, as by the commenter can only be made between the ratio of brain and RBC described in the preceding objection, it using that dataset. However, the dose inhibitions. Except at the lowest dose, is intrinsically flawed and scientifically levels in that study were so high that the which produced 50% AChE inhibition, invalid. lower portion of the dose-response where the ratio is slightly greater than ii. Denial of hearing request. A curve was missed. At these higher 2, the remaining ratios are only slightly hearing on this subissue is not doses, there is little difference between greater than 1. Given the inevitable appropriate because Petitioners’ request the levels of brain and RBC inhibition. statistical noise in these measures, it is is based on mere allegations, general This phenomenon—i.e., that the relative clear that the ratios expected from EPA’s contentions, and speculation (40 CFR sensitivity of RBC compared to brain modeling are substantially similar to the 178.32(b)(2)). No evidence has been appears smaller at higher doses—is also results the Petitioner finds in its submitted on any of the issues raised in shown in multiple chlorpyrifos studies comparison between individuals. this objection. Petitioners have provided where blood or peripheral measures of Accordingly, the Petitioners’ suggested no evidence that supports their AChE inhibition are more sensitive than comparisons at higher doses provide no assertion that EPA’s assumption that the brain at low to mid doses, but the evidence of what occurs at lower doses; dose-response curves will remain tissues appear to be similar at higher and thus provides no evidence that parallel at lower doses overestimates the doses. demonstrates that EPA’s modeling ratios. In the absence of data at the low Second, the Petitioners’ approach is results at lower doses is inaccurate. end of the dose-response curve, which fundamentally flawed. The Petitioners’ b. Objection/hearing request sub Petitioners were required to have suggested alternative relies exclusively issue: Scientific validity of EPA’s developed, there is just as great a on comparisons between the degree of approach. The Petitioners object that likelihood that EPA’s assumption inhibition in the treated animals EPA’s approach has not been underestimates the ratios. Petitioners without any regard to the doses at established as scientifically valid. They have not cited to any data from other which the effects occurred. For claim that data for other carbamates carbamates to support their contention example, one animal may have shown, suggests that BMD50 s for the carbamates that BMD50 s tend to diverge more than on average, 10% inhibition in the brain, tend to diverge more than the dose BMD10 s; the objection fails to even when it demonstrated 20% RBC levels used to select the PoD (i.e., the identify the carbamate chemicals that inhibition. Under this approach, what BMD10 s). In addition, they criticize purportedly support this claim. Further, would be relevant would simply be the EPA’s approach for incorrectly the claim is untimely, as it was not ratio of 1:2. But the Agency believes it assuming that the relationship between raised as part of their comments on the is critical to focus on the ratios of BMD50 s and BMD10 s is linear, which proposed rule. For the reasons potency, which is the ratio of the doses they claim overstates the potential discussed in Unit VI.D, EPA will not in the data that cause the same level of differences. They claim that these issues consider such information in support of AChE inhibition. The Agency’s could be avoided by adopting their a request to justify a hearing. approach of comparing potencies is suggested approach of using within- In addition, a hearing on this more directly relevant for regulatory animal comparisons to determine the objection is denied on the ground of purposes than comparisons of average relative sensitivity of RBC and brain materiality (40 CFR 178.32(b)(1)). In the inhibition. This is because dose AChE. The evidence submitted in absence of EPA’s assumption, EPA corresponds more directly to potential support of this subissue is the summary would have no basis for deriving an exposures, which is what EPA regulates presented in the objection. alternate children’s safety factor. Thus, (i.e., how much pesticide residue does i. Background. In the proposed rule, EPA would have to raise the children’s a child ingest). By comparison, the EPA explained that its comparisons of safety factor from 4X to the statutory
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default of 10X, rather than to lower the 2008 SAP concluded that ‘[w]hat the RBC data in PND11 animals for factor as the Petitioners seek. As Panel observed at the low end [of the carbofuran) and all available data in discussed at length in the preceding dose-response curve] made it tempting PND11 animals for brain. objection subissue, the Petitioners’ to assume linearity at this part of the In their comments on the proposed suggested alternative of within-animal dose-response curve’’ (Ref. 36 at 55). rule, Petitioners claimed that EPA’s comparisons is scientifically invalid, Regarding the Petitioners’ claim that decision to combine data for different and provides no useful basis for data for other carbamates suggests that strains of rats, sexes, experiments, regulatory action. Accordingly, if BMD50 s for the carbamates tend to laboratories, dates, dose preparations, Petitioners establish that available diverge more than the dose levels used rat ages, and times between dosing and information does not support EPA’s to select the PoD (i.e., the BMD10 s). EPA AChE measurement, is problematic, assumption that the dose-response cannot confirm the accuracy of this claiming that these differences in study curves are parallel, then EPA is left with allegation, as Petitioners have provided design severely limit the validity of no valid scientific information to neither data nor any explanation of a EPA’s comparisons. Further, they determine the correct dose-response biological basis to support this claim. alleged that differences in data and curve at lower doses, or to establish a Nor is EPA able to substantiate this methods EPA used to estimate its BMD10 (21 U.S.C. 346a(b)(2)(C)). claim based on the information BMD50 (brain) and BMD50 (RBC) caused Because deviation from a 10X children’s currently available. However, there is no EPA to overestimate the difference safety factor requires some ‘‘reliable a priori reason to expect such a between brain and RBC, and thereby data’’ on the shape of the dose response systematic divergence between ratios of invalidating any comparison of the curve for RBC AChE, Petitioners’ BMD50’s and ratios of BMD10 s for blood estimates. Specifically, Petitioners were objection on EPA’s low dose-response and brain, based either on biology or the concerned that the datasets from the six curve assumptions, in combination with mathematical relationship between studies EPA used for brain differ not the failure to provide a valid alternate BMD50’s and BMD10 s. It is actually far only because they were from different approach would result in a higher more probable that the variation from studies, but also because the data were children’s safety factor, and a chemical to chemical (due both to real taken at different times ranging from 15 conclusion that EPA has underestimated variation among chemicals and to minutes to 4 hours after dosing. carbofuran’s risks. statistical sampling noise) would be EPA responded to these comments in iii. Denial of objection. EPA disagrees large enough to make a conclusive full during the rulemaking (74 FR that its approach is not scientifically determination from data difficult. 23055–23057 (May 14, 2009); Ref. 85). valid. The models used to develop the c. Objection/hearing request sub Petitioners referenced these comments BMD estimates have been repeatedly issue: Combining data from different in their objections, but presented no reviewed and approved by the SAP toxicological studies—i. Background. In further argument or evidence on any of (Refs. 34, 35). The most recent occasion its risk assessment, EPA relied on all of these points. Because Petitioners was the February 2008 carbofuran SAP, the valid data from the available studies originally raised this claim also with which concluded that ‘‘[t]he dose- to calculate the estimates that served as respect to the derivation of EPA’s PoD, response analysis done by the Agency the PoD, and to calculate the estimates even though they only raise it in this for the EPA–ORD PND11 study was of BMD50 s that serves as quantitative objection here, the Agency responds to appropriate and led to a very uncertain support for derivation of the 4X both points below. BMD10 * * * This [assumed dose- children’s safety factor. ii. Denial of hearing request. The response] curve fit well in the region For purposes of the PoD, the Agency Petitioners have not met the where there were data, but there was no used a meta-analysis that combined requirements for a hearing on this way to validate it at low doses’’ (Ref. 36 valid data from all available studies to subissue. Petitioners have not at 54). calculate the BMD10 and BMDL10 for challenged the basis EPA asserted for EPA acknowledges that it lacks pups and adults; this analysis includes rejecting their suggested within-animal information to confirm its assumption brain data from studies where either analyses, and have therefore failed to that the dose-response curves remain adult or juvenile rats or both were lodge a relevant objection. Both EPA parallel at lower doses. EPA believes exposed to a single oral dose of and FDA precedent make clear that this is the most reasonable assumption, carbofuran. The quality brain AChE data when the agency substantively responds given the absence of information at low from the three studies (2 FMC, 1 EPA– to comments on the proposal, the doses, since it neither presumes that ORD) conducted with PND11 rats, in commenter may only keep that issue RBC inhibition will increase or decrease combination, provides data to describe alive in its objections by addressing the at lower doses. Contrary to Petitioners’ both low and high doses. By combining agency’s substantive response (40 CFR naked assertion that EPA’s approach the three studies in PND11 animals 178.32(b)(3)). Nor have they proffered overestimates the difference, there is no together in a meta-analysis, the entire any evidence that calls the substance of inherent reason to expect that EPA’s dose-response range is covered. EPA’s conclusions into question. A assumption would overestimate or EPA also combined studies in hearing is not warranted on the basis of underestimate the difference between calculating the 4X children’s safety mere denials or contentions (40 CFR BMD50 s and BMD10 s. If indeed data factor. EPA derived the ratio of RBC and 178.32(b)(2)). See 73 FR 42698–42699 were to show that EPA’s assumption brain AChE inhibition using the data on (When an objector does not challenge overestimated the difference—and administered dose for the PND11 EPA conclusions in the section Petitioners have submitted none—it animals from the EPA–ORD studies and 408(d)(4)(iii) order but rather challenges would only be as a result of the animal the FMC studies combined. In other some prior conclusion that was biology, as there is no indication in the words, EPA estimated the BMD50 for superseded by the section 408(d)(4)(iii) mathematical modeling that it PND11 animals for RBC and brain from order, the objector has not raised a live overestimates the difference in any way. each quality study and used the ratio controversy as to an issue material to The mathematical relationship between from the combined analysis, resulting in the section 408(d)(4)(iii) order); 53 FR BMD50 s and BMD10 s certainly provides a BMD50 ratio of 4.1X. EPA estimated 53176, 53191 (December 30, 1988) (FDA no hint that there might be a bias. In this the RBC to brain potency ratio using denied a hearing request noting that regard, it is notable that the February EPA’s data for RBC (the only reliable given FDA’s prior conclusion that the
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studies relied upon by the objector were and males provide BMDL10 s of 0.009 any differences in the way in which the unreliable, the ‘‘burden shifted to [the mg/kg/day and 0.014 mg/kg/day, studies were conducted did not impact objector] to maintain the viability of its respectively. When the datasets were the validity of EPA’s analyses. For objection by proffering some combined, inclusion of the 30-minute example, one of Petitioners’ complaints information that called into question the timepoint from MRID no. 47143705 was that it was inappropriate to agency’s conclusion on this matter.’’)). decreased the BMDL10 from 0.033 mg/ combine studies because the data in the Second, this objection is not material. kg/day to 0.030 mg/kg/day. studies were taken at different times, In the case of carbofuran, EPA used a Although the Petitioners complain ranging from 15 minutes to 4 hours after sophisticated analysis of multiple that EPA’s approach of combining data doses. EPA responded to the allegation studies and datasets to develop the PoD across multiple studies is scientifically that this was problematic by conducting for the carbofuran risk assessment. inappropriate, the Petitioners the analysis that the Petitioners claimed Instead of this analysis, EPA could themselves combined the results of should have been done to support this. simply have followed the general analysis from four datasets in the As explained in the final rule, although approach laid out in its BMD policy information presented with their EPA disagreed with the Petitioners’ (Ref. 100), which is used in the majority comments and referenced in their contention that this was necessary or of risk assessments. Under this general objections. Indeed, it is notable that appropriate, EPA conducted the approach, EPA would regulate using the most of the criticisms raised by the Petitioners’ suggested analysis, and used most sensitive effect, study, and/or Petitioners also apply equally to the the dose-time-response model to dataset. If the Agency chose not to Petitioners’ own analysis, as described extrapolate BMD50 s to develop a combine the data in its analyses, as the in more detail in EPA’s Response to common point of comparison between commenters’ suggested, data collected at Comments document (Ref. 85). all studies. Specifically, EPA or near the peak time of effect (i.e., 30 The Petitioners are also incorrect that extrapolated the PND11 brain analysis minutes) would in fact provide the more differences in the data available for to estimate BMD50 for 40 minutes after relevant datasets. If this more simple brain and RBC are so great as to dosing for comparison with the existing approach were taken, in accordance invalidate comparisons of the BMD PND11 RBC BMD50, and extrapolated with BMD guidance, EPA would select estimates. EPA used all the data the PND11 RBC BMD50 to 15 minutes the lowest BMDL10. Assuming the available in each case, and used a after dosing for a range of assumed commenters’ values were used, EPA hierarchical model to account for recovery half-lives, for comparison to would have selected a PoD of 0.009 mg/ variability of the BMD among the existing PND11 brain BMD50. The kg/day, instead of the 0.03 mg/kg/day laboratories for the brain endpoint, results are provided in (Refs. 24, 25). In that EPA is currently using in its risk which the SAP has explicitly reviewed either approach, the estimate of the RBC assessment. A lower PoD of 0.009 mg/ and approved numerous times (Refs. 34, to brain potency ratio in PND11 animals kg/day would significantly increase 35, 36). is increased, and EPA’s safety factor carbofuran’s level of estimated risk. The Petitioners are correct that data would correspondingly increase to iii. Denial of objection. In general, from both sexes were combined for reflect that larger difference. For EPA believes that consideration of all brain but only male data were used for example, when the PND11 brain BMD50 available data is the scientifically more RBC. However, EPA first performed an is extrapolated to 40 minutes, the RBC defensible approach, rather than the evaluation of the differences between to brain potency ratio grows to 4.7 (Ref. selective exclusion of reliable data. The the sexes. EPA combined data from 24 at 46), and when the PND11 RBC Agency’s Draft BMD Guidance says the males and females only after showing BMD50 is extrapolated to 15 minutes, following: ‘‘Data sets that are that they did not respond differently.14 using a range of estimates for the statistically and biologically compatible The only remaining study to examine recovery half-life of the RBC endpoint, may be combined prior to dose response AChE activity in RBC in PND11 the RBC to brain potency ratio ranges modeling, resulting in increased animals, after FMC’s flawed studies from 4.2 to 4.6 (Ref. 24). The Petitioners’ confidence, both statistical and were eliminated, contained only male approach would therefore support a biological, in the calculated BMD’’ (Ref. animals. Both BMD50 s for brain and children’s safety factor of 5X rather than 76). The SAP has reviewed and RBC in adults were based on 15 the 4X EPA is currently applying in its approved EPA’s practice of combining minutes, the minimum time interval risk assessments. Nevertheless, EPA data from studies numerous times (Refs. after dosing when a sample was taken, continues to believe that its current use 34, 35, 36). Most recently, as part of the in each dataset.15 This is also true for of a 4X factor reflects the most reliable carbofuran SAP, the SAP was fully the brain endpoint in PND11 animals. interpretation of existing quality data. aware that the Agency was planning to However, the only study available of the Although it is true that EPA’s BMD50 derive BMD estimates from data sets RBC endpoint in PND11 animals was for brain was based on data from 6 using different strains of rats (Ref. 36). conducted at 40 minutes after dosing, datasets while the RBC BMD50 was Accordingly, the Agency’s carbofuran and did not include a recovery time based on a single study, this is because analysis has included all available, valid course study. scientifically acceptable RBC data are data in its analysis. EPA believes that its decision to only available from a single study. As By contrast, the Petitioners’ suggested combine data for purposes of its BMD discussed, the fact that EPA used all analysis ignores relevant, scientifically 50 estimates supporting the children’s available data sets in its modeling does valid data. Their analysis left out the 30- safety factor is equally appropriate, and not affect the validity of its modeling minute data from MRID no. 47143705 (Ref. 76). (Ref. 2), but provided no rationale as to For all of the foregoing reasons, this 14 See pp. 34–35 in the brain document dated why it would be appropriate to October 25, 2007 for adults, pp. 47–48 in the same objection is denied. selectively exclude data from the time document for PND11 animals; p. 15 in the RBC d. Objection/hearing request sub frame in this study most relevant to the document dated October 23 for adults. issue: Technical Flaws in EPA’s risk assessment (i.e., peak AChE 15 See Oct. 5, 2007 reports, page 8 (for the values statistical comparisons. In their of the time interval) and page 63 (setting the inhibition). The Petitioners’ analysis of parameter delta to the minimum non-zero value for objections, Petitioners claim to have the individual datasets from this study that interval) in the RBC report, and page 9, and found a number of technical errors and showed that at 30 minutes the females page 45 for the corresponding report for Brain. inconsistencies in how the modeling
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was conducted. Correcting for these Petitioners have provided little detail account for EPA’s analyses, the errors, they claim, shows that the BMDs in their objections on the issues they objections are contradicted by the for brain and RBC data are essentially intend to raise in their testimony; in record, and accordingly, fail to the same, which was consistent with the most instances, they simply allege that demonstrate a factual dispute (40 CFR results of modeling conducted by the EPA’s modeling was incorrect. But as 178.32(b)(1)). See 73 FR 42698–42699 Petitioners when evaluating the the objections reference the Petitioners’ (Denying NRDC hearing where objection individual animal data. Specifically, comments on the proposed rule, EPA reiterated claims premised on Petitioners allege that the approach EPA assumes that they intend to raise only conclusions in EPA’s preliminary risk used to estimate BMD50 s for carbofuran the points previously discussed in their assessment, rather than objecting to is inconsistent with its ‘‘meta-analysis’’ comments. EPA’s conclusions in the revised approach of combining studies. The ii. Denial of hearing request. The assessment prepared for the petition Petitioners also argued that EPA’s Petitioners’ request for a hearing on the denial); 49 FR 6672 (February 22, 1984) modeling failed to account for issues raised in this objection is denied (no hearing if claim based on significant difference in study on two bases. First, Petitioners have not demonstrably false premise); 57 FR 6667 methodologies (e.g., time to sacrifice challenged the substance of EPA’s (February 27, 1992) (‘‘A hearing must be following dosing). For example, EPA’s response to their comments or based on reliable evidence, not on mere BMD50 (Brain) is calculated at 15 submitted evidence that calls the allegations or on information that is minutes after exposure starts whereas substance of EPA’s conclusions into inaccurate and contradicted by the EPA’s BMD50 (RBC) is calculated at 40 question. As previously explained, their record’’). minutes after exposure starts. EPA’s failure to challenge the actual basis of Second, as in their comments, BMD50 (brain) is based on 6 studies EPA’s final rule affects the materiality of Petitioners failed to submit the whereas EPA’s BMD50 (RBC) is based on the objection and hearing request (40 underlying modeling they claim to have 1 study, and the dose-time-response CFR 178.32(b)(3)). See 73 FR 42698– conducted in support of their modeling methodology for combined 42699 (When an objector does not objections. Petitioners’ consultants studies and EPA’s BMD50 (brain) is challenge EPA conclusions in the merely assert that the results are as different than the dose-time response section 408(d)(4)(iii) order but rather presented in their summarized modeling methodology for a single challenges some prior conclusion that testimony. In the absence of the study and EPA’s BMD50 (RBC). was superseded by the section underlying scientific analyses, these are Petitioners also allege that EPA applied 408(d)(4)(iii) order, the objector has not effectively no more than mere allegation its dose-time-response model raised a live controversy as to an issue or general contentions. Hearings will inconsistently between the brain and material to the section 408(d)(4)(iii) not be granted on this basis. (40 CFR RBC calculations, alleging that the order) 53 FR 53176, 53191 (December 178.32(b)(2); see also 68 FR 46403, power was fixed to 1.00 for brain, but 30, 1988) (FDA denied a hearing request 46406–46407 (August 5, 2003) (FDA estimated for RBC.’’ They also criticize noting that given FDA’s prior denied a hearing involving a challenge the modeling on the grounds that EPA conclusion that the studies relied upon to FDA’s reliance on consumption did not: (1) Account for differences by the objector were unreliable, the pattern data because the objector ‘‘did between the combined datasets; (2) ‘‘burden shifted to [the objector] to not present any specific information to develop a protocol supporting its maintain the viability of its objection by dispute P & G’s consumption pattern approach; (3) clearly document its proffering some information that called data; instead, [objector] simply asserted method; (4) accurately document model into question the agency’s conclusion that other consumption patterns were parameters; (5) rely on a plausible dose- on this matter.’’)). Further, Petitioners likely.’’); accord Community Nutrition response model, or (6) report its data have not rebutted, or even Institute v. Novitch, 773 F.2d 1356, 1363 accurately or transparently. They further acknowledged, the additional analyses (DC Cir. 1985) (‘‘Mere differences in the allege that ‘‘removing all of these EPA undertook at their suggestion, and weight or credence given to particular inconsistencies in methodology results discussed in the final rule, which scientific studies * * * are insufficient in a ratio of 1.3, which corresponds with ultimately provided further support for [to show a material issue of fact for a the ratio that the Petitioners claim to EPA’s position. For example, in hearing].’’). have obtained based on their within response to the complaint that EPA iii. Denial of Objection. For all of the animal comparisons. should have generated a new dose- reasons discussed in the final rule and Petitioners have provided neither response model in order to calculate the Response to Comments documents, this further details of their concerns than the BMD50 s for brain and RBC, EPA objection is denied. A summary of explanation above, nor any other conducted the suggested calculation, EPA’s bases, which were discussed in evidence to support this objection. and under that analysis, the result is the detail in both the final rule and i. Background. EPA addressed all of same as that EPA originally calculated. Response to Comments document, is the commenters’ claimed Similarly, in response to the complaint presented below. inconsistencies in its final rule and that EPA should have used the dose- Consistency of EPA approach. In their Response to Comments document (74 time-response model to extrapolate comments, the Petitioners’ explained FR 23055–23056; Ref. 85 at 61–62). For BMD50 s to develop a common point of that the alleged inconsistency with the majority of these claimed flaws and comparison between all studies, EPA which they were concerned was that inconsistencies, EPA explained that the conducted that analysis and described it ‘‘EPA attempts to extrapolate a BMD10 to Petitioners had misunderstood EPA’s in the final rule (74 FR 23055–23056 a BMD50 without refitting the data. That analyses, or that the Petitioners’ were (May 15, 2009)). The result of this is, EPA uses the dose-response model incorrect. However in response to reanalysis supported a higher children’s obtained for the BMD10 rather than certain allegations, EPA conducted new safety factor than EPA’s 4X. But rather obtaining a new model for BMD50.’’ analyses to determine whether the than challenge the new analysis, They claimed this was ‘‘especially suggested alternative approaches would Petitioners simply repeat the assertions troublesome since EPA has expressly make any significant difference in EPA’s made in their comments. Because the stated that the model obtained for modeling outcomes. objections on these points fail to BMD10 (RBC) is unreliable.’’
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The Petitioners’ allegation on this Although it is true that EPA’s BMD50 rankings of carbamates proposed by the point is incorrect. The model itself does for brain was based on data from 6 SAP in its assessment of the NMCs not need to change in order to develop datasets while the RBC BMD50 was (which also considered the rate of a BMD50. Whether one wants to estimate based on a single study, this is because recovery) also showed aldicarb having the BMD10 or the BMD50, one would use scientifically acceptable RBC data are approximately twice the potency of the same underlying model. EPA simply only available from a single study. As carbofuran. They further alleged that the developed a mathematical expression to discussed in the preceding objection children’s safety factor for carbaryl was adjust parameter values for that fitted response, the fact that EPA used all inconsistent with the safety factor model so that, for any given benchmark available data sets in its modeling does applied to carbofuran. Finally, the response level (in particular, for 10% or not affect the validity of its modeling Petitioners compared the aPAD, aRfD, 50% inhibition), the corresponding (Ref. 76). and uncertainty factors for oxamyl, BMD could be estimated as a parameter Inconsistent application of model. aldicarb, and carbaryl, concluding that in that model. The same expression EPA did not apply its model these were inconsistent with EPA’s makes it possible to compute a BMD for inconsistently; the difference to which conclusions for carbofuran. any given response level from estimates the Petitioners refers results from the EPA responded to these comments in based on any other response level. differences between the available data. both the final rule and the Mathematically, it is not necessary to In order to generate an estimate of the accompanying response to comments refit the model to the data to estimate power parameter, data at both extremes document (74 FR 23058 (May 15, 2009)). different BMD levels. of the dose-response curve are In their objections, Petitioners have However in response to the necessary. Despite the comparatively not identified any specific facts that comments, EPA conducted their greater amount of brain inhibition data, they believe demonstrate inconsistency. suggested calculation, and the ratio of the brain data did not provide They merely allege that the ‘‘relative brain to RBC BMD50 s in this new information at both extremes of the potency of carbofuran as compared to analysis is the same as the ratio EPA curve. A value of 1.00 is the standard other N-methyl carbamates does not calculated by using the mathematical default in this situation for all the NMC correspond with OPP’s aPAD for expression (Refs. 24, 25). Both provide dose-response analyses. Moreover, carbofuran relative to those same a ratio of brain to RBCs BMD50 of 4X. despite the limited information at the compounds.’’ Specifically, in the just cited documents extremes of the dose-response curve for ii. Denial of hearing request. A above, the values are for PND11 brain estimating power in the brain data, a hearing is denied on this subissue BMD50 are 0.35 (Ref. 24 at 40) and for power parameter of 1.00 is consistent because there is no disputed factual RBC, 0.086 (Ref. 25 at 20), resulting in with the available brain data. By matter for resolution at a hearing. There a ratio of 4.09. contrast, because the available RBC data is no dispute concerning the children’s With regard to the EPA’s purported provides the necessary information at safety factors that EPA applied to the statement that the BMD10 model is higher doses, the power in the RBC data other carbamates, nor how EPA derived unreliable, the Petitioners misconstrued could be directly estimated and was those safety factors. Thus, the only EPA’s statement. EPA stated that it significantly less than 1.0. question is whether it was reasonable cannot reliably estimate the RBC BMD10 EPA is unable to comment on the for EPA to account for the fact that other and BMDL10 in pups because it lacks analyses referenced in the Petitioners’ chemicals had a greater amount of data at low doses, not because its model objections as they failed to provide toxicity data, and therefore greater is unreliable. Given the greater amount them. However, EPA has previously uncertainty, in determining the of data, the estimate for the BMD50 is explained the reasons for rejecting the appropriate children’s safety factor, substantially better supported, and thus, suggested analysis based on brain RBC when the statute requires EPA to less uncertain, than the estimate of the comparisons within the same animal. account for ‘‘the completeness of the BMD10. This is discussed at length in the final data’’ (21 U.S.C. 346a(b)(2)(C)). This Differences in study methodologies. rule and response to comments, as well question requires the application of a Both BMD50 s for brain and RBC in as Unit VI.E.2.a of this Order. legal standard to undisputed facts. adults were based on 15 minutes, the f. Objection/hearing request sub issue: Hearings are not appropriate on minimum time interval after dosing Consistency in approach between questions of law or policy (40 CFR when a sample was taken, in each carbofuran and other NMC chemicals— 178.32(b)(1)). See, 73 FR 42706–42707) dataset.16 This is also true for the brain i. Background. In their comments on the (denying NRDC hearing request when endpoint in PND11 animals. However, proposed rule, the Petitioners argued the only question raised was whether a the only study available of the RBC that EPA’s approach to deriving human study using only adult males endpoint in PND11 animals was carbofuran’s children’s safety factor was met the regulatory requirement of conducted at 40 minutes after dosing, inconsistent with its approach to ‘‘scientifically valid and relevant data’’. and did not include a recovery time deriving the safety factors for other FDA has repeatedly confirmed that the course study. NMC pesticides. They identified only application of a legal standard to As noted in the previous objection three specific chemicals: Aldicarb, undisputed facts is a question of law for response, EPA used the dose-time- oxamyl, and carbaryl. With respect to which a hearing is not required. (See, response model to extrapolate BMD50 s aldicarb they argued that although the e.g., 68 FR 46403, 46406 n.18, 46408, to develop a common point of relative potency of carbofuran is less 46409 (August 5, 2003) (whether facts in comparison between all studies. Using than aldicarb, the uncertainty factors the record show there is a reasonable that approach would support a assigned by EPA presuppose that certainty of no harm is a question of children’s safety factor of 5X rather than carbofuran is ten times more toxic that law; whether a particular effect is a the 4X EPA has applied. aldicarb. They claim that the aldicarb ‘‘harm’’ is a question of law)). data show that by all objective measures In addition, Petitioners have not 16 See Oct. 5, 2007 reports, page 8 (for the values of toxicity, aldicarb is nearly twice as challenged the substance of EPA’s of the time interval) and page 63 (setting the acutely toxic as carbofuran across all response to their comments, but simply parameter delta to the minimum non-zero value for that interval) in the RBC report, and page 9, and species tested. They further claim that reiterated their comments on the page 45 for the corresponding report for Brain. an alternative approach to relative proposed rule. Accordingly, a hearing is
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not warranted, as the objection is approach to the assessment of accepted by the HSRB for both scientific subissue is irrelevant, and therefore carbofuran. validity and ethical conduct. This is not immaterial, with regard to EPA’s final The Petitioners’ assertions regarding the case for carbofuran. As discussed tolerance revocation regulation (40 CFR aldicarb were based on an earlier below in Unit VI.G, the HSRB 178.32(b)(3)). See 73 FR 42698–42699 assessment. At the time the Agency concluded that the carbofuran study (July 23, 2008) (When an objector does conducted the assessment to which the was not sufficiently scientifically robust not challenge EPA conclusions in the commenters refer, the Agency was for use in the risk assessment. section 408(d)(4)(iii) order but rather unaware of the difference in sensitivity Therefore, there is less uncertainty in challenges some prior conclusion that between PND17 and PND11 animals. the aldicarb and oxamyl risk was superseded by the section Since EPA became aware of the assessments since quality data are 408(d)(4)(iii) order, the objector has not differences, EPA has required the available in humans and the raised a live controversy as to an issue aldicarb registrant to conduct a CCA interspecies factor can be reduced or material to the section 408(d)(4)(iii) study in PND11 rats; the Agency removed for these chemicals. There are order; 53 FR 53176, 53191 (December anticipates the receipt of this study and no comparable data for carbofuran. 30, 1988) (where FDA responds to a the companion range-finding and time Accordingly, this objection is denied. comment in the final rule, repetition of course studies in 2009. In the absence F. Objections to EPA’s Drinking Water the comment in objections does not of these data, EPA will apply the Exposure Assessments. present a live controversy unless the statutory default children’s safety factor Petitioners raise separate objections to objector proffers some evidence calling to account for the additional sensitivity EPA’s estimates of drinking water FDA’s conclusion into question)). of PND11 animals, because the Agency exposures from contaminated ground Nor have they submitted evidence lacks any ‘‘reliable data’’ that could be water and to the estimates from that calls the substance of EPA’s used to derive a reduced factor that EPA contaminated surface water. In each conclusions into question. Petitioner’s could determine will be ‘‘safe for infants objection, Petitioners argue that, based entire argument concerning this issue is and children.’’ on newly proposed restrictions a single conclusory sentence. A hearing With regard to the carbaryl children’s submitted as part of their objections, the will not be granted on ‘‘mere safety factor, the available brain and exposure estimates will be significantly allegations’’ or ‘‘general contentions.’’ RBC dose-response data in PND11 pups lower than EPA’s estimates in the final (40 CFR 178.32(b)(2)) (See 53 FR 53176, include data from the lower end of the rule. 53199 (December 30, 1998)) (‘‘Rather dose-response curves. ORD’s 1. Objections relating to groundwater than presenting evidence, [the objector] comparative AChE data with carbaryl exposure estimates. Petitioners raise asserts that FDA did not adequately show that at the lowest dose 20% or several challenges to the ground water justify its conclusions. Such an near 20% inhibition in brain and RBC concentration estimates in the final rule. assertion will not justify a hearing.’’). AChE was observed. Although not ideal, They allege that EPA’s estimates are not iii. Denial of objection. Although it is the carbaryl data provide information based on the best available data, but on unclear which precise chemicals the closer to the benchmark response of obsolete data and overly conservative Petitioners believe demonstrate that 10%, which allows for a reasonable assumptions that are inappropriate EPA was inconsistent, the only ones on estimation of the BMD10 and BMDL10. because use has been prohibited in all which any allegations were arguably This is distinctly different from ORD’s areas like those seen in these data. The presented were those identified in their data with carbofuran in PND11 and objection also claims that the comments on the proposed rule: PND17 pups where 50% or greater RBC requirements in the new registration aldicarb, carbaryl, and oxamyl. AChE inhibition was observed at the proposals to require setbacks from all Accordingly, EPA denies this objection lowest dose. drinking water wells ranging between for the same reasons that EPA explained Petitioners’ other comparisons are 100 and 1,000 feet will ensure that all in its final rule and comment responses. equally inapposite. The LD50, BMDL10, potential groundwater exposures will be In their comments, the Petitioners and relative potency factor from the below the level of concern. In support cumulative risk assessment are each provided information on the oral LD50 of this objection three analyses were measures of chemical potency. Thus, in rat and the BMDL10 for AChE in rat submitted in Exhibits 12, 13, and 14. brain or human RBC. The comments these calculations provide reasonable a. Objection/hearing request subissue: also provided uncertainty factors for the comparisons of the relative potency of Reliance on the results of the three NMCs, the respective aRfD 17 or aldicarb, carbofuran, and oxamyl. prospective ground water study (PGW) aPAD 18 and the cumulative risk However, the Petitioners’ allegations and historical monitoring to validate assessment oral potency factor. The were based on comparisons of the groundwater exposure estimates. The aPAD, aRfD, and uncertainty factors, Petitioners object that EPA should not LD50 and BMDL10, values provided are not completely accurate. which are not measures of potency and have relied for validation on their PGW The allegations and the supporting should not be interpreted as such (Ref. study or historical monitoring data. information contained in Petitioners’ 79). The magnitude of the uncertainty They argue that these data are from a comments were inaccurate. For factors is intended to account for period when use was an ‘‘order of uncertainty in the available data for a example, the LD50 values in the oxamyl magnitude greater.’’ Additionally they RED were 3.1 mg/kg (male) and 2.5 mg/ particular chemical. For example, it is allege that all areas like those seen in kg (female), rather than 30 mg/kg as the standard practice to apply a 10X the PGW have now been removed from Petitioners claimed. Further, the uncertainty factor for extrapolation from the carbofuran label, and so the study Agency’s recent hazard assessments of animals to humans when ethically and results do not accurately reflect current carbaryl and aldicarb are each scientifically sound human data are not risks. In support of this objection, consistent with EPA policies and available for the pesticide of interest. Petitioners reference their comments on practice, as well as with the Agency’s And this explains the difference in the the proposed rule, and Exhibit 12. uncertainty factors applied to the three i. Background. In the proposed rule, 17 aRfD is the acute reference dose. chemicals. Deliberate dosing studies in EPA relied on a drinking water 18 aPAD is the acute RfD adjusted for the human subjects conducted with aldicarb assessment that used both monitoring Children’s Safety Factor. and oxamyl were reviewed and data for carbofuran and modeling
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methods (Refs. 13, 42, 44, 47, 67). Tennessee (1 county). Analysis of the fact that EPA scaled the PGW modeling Regarding the potential exposure from impact of these setbacks for the use on to reflect the lower current use rates. contaminated groundwater, the Agency corn indicated that the setbacks would The Petitioners present no challenge to concluded that drinking water taken not reduce concentrations significantly the methods EPA used to scale the study from shallow wells is highly vulnerable at locations where exposure to results; indeed, it is likely that their to contamination in areas where carbofuran in ground water is of contractor used the same or similar carbofuran is used around sandy, highly concern because at acid pHs, carbofuran methodology. Equally, the objection that acidic soil, although sites that are less does not degrade sufficiently during the EPA relied on ‘‘historical monitoring vulnerable (e.g., deeper aquifer, higher travel time from the application site to data from a period when carbofuran use organic matter) could still be prone to the well to substantially reduce the was an order of magnitude larger’’ is have concentration exceeding concentration. simply incorrect (Ref. Obj at 40). The acceptable exposures. EPA concluded EPA concluded that the results of the monitoring results EPA cited in the final that the results of its modeling were revised corn modeling were consistent rule were from the 1980s, but the consistent with the results of the with the PGW. Using higher use rates targeted monitoring studies were available monitoring data, including a than currently permitted, the peak conducted with the same or lower use PGW study conducted by FMC in the concentration measured in the PGW rates as those permitted under the 1980s, when scaled to reflect the current study was 65 ppb; when scaled to current labeling (74 FR 23085, May 15, lower rates of application (73 FR 44881). current use rates, the estimated peak 2009). Such a submission is insufficient In their comments, the Petitioners concentration was 11 ppb. The final rule to justify a hearing (See, 73 FR 42696 complained that EPA’s reliance on the explained that EPA’s modeling is also (July 23, 2008)(denying hearing where PGW was inappropriate because that consistent with a number of other objector incorrectly claimed that EPA study no longer reflected current targeted groundwater studies conducted had failed to rely on DDVP-specific conditions. Petitioners also summarized in the 1980s showing that high information in making its children’s the results of their ‘‘National Leaching concentrations of carbofuran can occur safety factor determination); 57 FR 6667 Assessment’’ which used PRZM and in vulnerable areas; the results of these (February 27, 1992) (‘‘A hearing must be ‘‘databases specifically created to studies as well as the PGW study are based on reliable evidence, not on mere provide access to all necessary inputs summarized in References 13 and 67 (74 allegations or on information that is for a national scale PRZM modeling.’’ FR 23079). inaccurate and contradicted by the They claimed that after accounting for ii. Denial of hearing request. For this record.’’) the use prohibitions on their September hearing request, the Petitioners have Further, the Petitioners’ 2008 label, the maximum 1-in-10 year failed to proffer evidence, which would, misrepresentation of EPA’s analyses peak concentrations in all potential if established, resolve a material issue in also affects the materiality of the hearing carbofuran use areas is 1.2–1.3 ppb, their favor. First, Petitioners’ request (40 CFR 178.32(b)(3)). Even if while expected concentrations in most evidentiary proffer does not support Petitioners were able to successfully areas covered by this assessment are their contention, and consequently, EPA refute the validity of the PGW study, it below 1.0 ppb. Neither the ‘‘National is unable to conclude that there is a would not affect the validity of the Leaching Assessment’’ nor the reasonable possibility that the issue additional monitoring data cited in the ‘‘National Pesticide Assessment Tool’’ could be resolved in its favor (40 CFR final rule (74 FR 23079 (May 15, 2009)), upon which the assessment appears to 178.32(b)(2)). Petitioners’ own experts on which EPA also relied to validate its have been based, were submitted to EPA relied on the PGW to validate the monitoring. See, 49 FR 6672 (February as part of the Petitioners’ comments. modeling submitted in support of this 22, 1984) (challenge to one of five In the final rule, EPA revised the objection and to demonstrate the safety related studies; in the absence of any assessment conducted for the proposed of the tolerances. The Executive additional data bearing on the clinical rule in response to the FMC comments Summary of the National Carbofuran study, the objection constitutes nothing submitted during the comment period, Leaching Assessment states more than an allegation). which requested cancellation of the use Finally, the evidentiary proffered with on a number of crops and imposed a ‘‘[a] model validation study was conducted respect to the Petitioners’ allegation that number of restrictions intended to in which the results of a prospective all areas with conditions similar to address the potential for groundwater groundwater monitoring (PGW) study those found in the PGW have been contamination. These restrictions conducted for cabofuran in Maryland from removed from the label is insufficient to 1981–1983 were compared to the model included use prohibitions in certain simulations that most closely matched the warrant a hearing (40 CFR 178.32(b)(2)). states, and well setbacks. Taking these PGW study site in terms of location, soil To the extent this allegation is based on into account, ground water texture, organic carbon content, and pH. The the information presented as part of the concentrations were estimated for all annual peak concentrations during the 2008 comments, this claim was rebutted remaining crops on carbofuran labels, simulation are on the order of 9 to 11 ppb, in EPA’s final rule, by the modeling using two new Tier 2 scenarios. Based which are similar to the measured based on the Wisconsin corn scenario, on a new corn scenario in Wisconsin, concentrations in the PGW study (9 to 10 ppb and by the lack of any underlying representative of potentially vulnerable after adjusting for application rate). The analyses to support of Petitioners’ areas in the upper Midwest where use validation provides context that the model comments. As explained in the final remained, EPA estimated one-in-ten predictions are reasonable.’’ rule, the information provided is year concentrations for ground water (Exhibit 12 at 7). See, e.g., 57 FR 33244 insufficient to allow EPA to confirm the source drinking water of 16 to 1.6 × (July 27, 1992) (Studies cited by NRDC Petitioners’ contention that there is no 10¥3 ppb, for pH 6.5 and 7, do not provide a basis for the hearing overlap between use and all potentially respectively. Well setback prohibitions because they ‘‘support the [FDA] vulnerable ground water (74 FR 23061– of 50 ft were proposed on the new label conclusion in question.’’). 23062 (May 15, 2009)). for the flowable and granular Second, this objection is premised on The evidence submitted along with formulations in select counties in inaccurate factual statements that are this objection does not cure this defect. Kentucky (7 counties), Louisiana (1 directly contradicted by the record. For The only evidence proffered in this county), Minnesota (1 county), and example, the objection disregards the regard is the Petitioners’ comments on
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the proposed rule, and the new analysis submitted were all on a nation-wide 1980s. Using higher use rates than submitted in Exhibit 12. As previously scale, which does not provide the level currently permitted, the peak discussed, mere reiteration of comments of detail necessary to verify the concentration measured in the PGW made in response to the proposed rule combination of paramaters (e.g., soil study was 65 ppb; when scaled to does not provide an adequate basis for textures, pH) at locations identified as current use rates, the estimated peak a hearing, unless the objector proffers vulnerable. Further, the maps provided concentration was 11 ppb. EPA’s some evidence calling EPA’s conclusion by the Petitioner do not represent all modeling is also consistent with a into question. Consequently, Petitioners’ carbofuran use patterns. For example, number of other targeted ground water submission on this issue is irrelevant Figure IV–2 on page 42 of the studies conducted in the 1980s showing and therefore immaterial, with regard to Petitioners’ comments does not address that high concentrations of carbofuran EPA’s final tolerance revocation (40 CFR the granular use patterns and proposed can occur in vulnerable areas; the 178.32(b)(3)). The analysis in Exhibit 12 label prohibitions. In addition, as a results of these studies as well as the appears to be the National Leaching general matter, none of the previously PGW study are summarized in Assessment described in Petitioners’ submitted assessments provided a References 13 and 67. For example, a comments, but modified to account for comprehensive analysis of the study in Manitoba, Canada assessed the the proposed amendments submitted as distribution of soil and water pHs for movement of carbofuran into tile drains part of the objections. As noted the Midwest, Northwest or any other and ground water from the application previously, neither the National region of the country where carbofuran of liquid carbofuran to potato and corn Leaching Assessment nor the model on use would be permitted on the fields. The application rates ranged which it was based was submitted as September 2008 label, or have the between 0.44–0.58 pounds a.i./acre, and part of the comments. Because the Petitioners provided such an analysis the soils at the site included fine sand, National Leaching Assessment was with their objections. loamy fine sand, and silt loam, with pH available during the comment period Further, the available scientific ranging between 6.5–8.3. Concentrations but was withheld, this information is information does not support their of carbofuran in ground water samples considered to be untimely and the contentions. EPA examined readily ranged between 0 (non-detect) and 158 Petitioners have waived the right to rely available data with respect to ground ppb, with a mean of 40 ppb (Refs. 13 on it. For the reasons discussed in Unit water and soil pH in order to evaluate and 67). VI.D, EPA therefore will not consider it the spatial variability of pH. Data from Finally, as discussed above, to the as an appropriate basis for justifying a the USGS and other readily available extent this objection relies on untimely hearing on its final rule. See 73 FR sources do not necessarily encompass information and analyses, and on the 42683, 42696 (July 23, 2008); 72 FR the entire range of ground water pH newly submitted registration 39318, 39324 (July 18, 2007). Further, values present within a state. This is amendments, the objection is denied as for the reasons discussed in Unit VI.C, especially true for shallow ground water irrelevant and immaterial. b. Objection/hearing request subissue: EPA has determined that objections and systems, where local conditions can Accounting for FMC’s label mitigation hearing requests based on the newly greatly affect the quality and measures. Petitioners object that EPA’s proposed amendments, as well as characteristics of the water. Also, pH in risk assessment relies on ‘‘unrealistic evidence or analyses premised on those a water body can be higher or lower and overly conservative assumptions amendments, are irrelevant, and than the tabulated average values. In addition, average ground water pH about potential concentrations,’’ and therefore immaterial, to EPA’s values for a given area do not truly fails to account for FMC’s label determination in the May 15, 2009 final characterize the area’s temporal and mitigation measures. They claim that rule that the carbofuran tolerances were especially spatial heterogeneity. This maximum concentrations of carbofuran unsafe and could not be sustained under can be seen by comparing differences in in groundwater are expected to be below FFDCA section 408. Petitioners are pH values between counties within a 1.1 ppb, based on the new proposed actually not objecting to the conclusions state, and by the fact that even within geographic restrictions and well in EPA’s final rule; rather, they are a county individual wells will setbacks. They allege that, ‘‘only suggesting that EPA might reach a consistently yield ground water with permeable soils (e.g., greater than 90% different result in a different factual either above- or below-average pH sand and less than 1% organic matter) scenario. Objections, however, must be values for that county. The ground with acidic soils and water conditions, directed ‘‘with particularity [at] the water simulations in Reference 84, and shallow water tables (e.g., less than provisions of the regulation or order Appendix I reflect variability in pH by 30 feet) are vulnerable to carbofuran deemed objectionable’’ (21 U.S.C. modeling carbofuran leaching in four applications.’’ They also claim that 346a(g)(2)). different soil and subsurface pH vulnerable groundwater only exists iii. Denial of objection. EPA denies conditions (pH 5.25, 6.5, 7.0, and 8.7), along eastern seaboard, and in select this objection on several bases. Based on representing the range in the aquifer counties in the United States, where use the information available, and even system in that area. This range also has already been prohibited. They argue accounting for the September 2008 approximates the pH range of natural that further confirmation is provided by geographic restrictions, the Agency waters in general. The results of the the available NAWQA data, which show cannot confirm the Petitioners’ claim ground water simulations for corn use that detections of carbofuran are rare, that use has been prohibited in all areas showed that a relatively small (0.5) and occur only at low levels except in with conditions similar to the PGW decrease in pH from 7 to 6.5 resulted in areas where use is now prohibited. study. Based on the information that an increase in the 1-in-10-year peak Finally, Petitioners allege that in the was timely submitted, the only concentrations of carbofuran in ground specific regions where carbofuran will information provided was in map water of 4 orders of magnitude. continue to be used under the revised format. While maps are useful for The results of EPA’s revised corn label, groundwater pH data collected interpreting results, maps alone are modeling, based on a new scenario in under the USGS NAWQA program insufficient for a thorough evaluation of Wisconsin, are consistent with the demonstrate that the average pH is the Petitioners’ claim, in part because of results of the PGW study developed by approximately 7.25, and in most the maps’ spatial resolution. The maps the registrant in Maryland in the early regions, moving two standard deviations
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away from average, which they claim areas possess sandy soil texture’’ and sustained under FFDCA section 408 (40 would capture 95% of all observed that ‘‘low pH conditions are not found CFR 178.32(b)(3)). Petitioners are values, results in pHs that are still in carbofuran use areas allowed under actually not objecting to the conclusions greater than 6.0. According to the the registrant’s amended label’’ (Ref. 18 in EPA’s final rule; rather, they are Petitioners, under such conditions the at 33–34). They described, but did not suggesting that EPA might reach a combination of hydrolysis and drinking submit analyses they claimed to have different result in a different factual water well setbacks would ensure that conducted to demonstrate this. The scenario. Objections, however, must be any carbofuran that might reach ground summary consisted primarily of maps directed ‘‘with particularity [at] the water sources would degrade to only de depicting areas identified as vulnerable. provisions of the regulation or order minimis concentrations less than or On December 24, 2008, FMC again deemed objectionable’’ (21 U.S.C. equal to 1.1 ppb. requested that EPA amend their 346a(g)(2)). In addition, for the reasons In support of this objection, registration to include additional discussed in Unit VI.D, EPA has Petitioners cite the analyses submitted restrictions intended to further mitigate determined that the new risk mitigation as part of their comments, and the new carbofuran’s risks to groundwater. measures are not appropriately analyses in Exhibits 12, 13, and 14. In response to the September 2008 considered at this stage of the Exhibits 12 and 13 contain the revised proposed label restrictions submitted as administrative process, and will not modeling of the estimated groundwater part of the comments, EPA revised its grant a hearing on this basis. concentrations from carbofuran use, risk assessment to take into account the Petitioners’ objections provide no based on the label restrictions proposed new geographic restrictions, as well as further clarification as to what is meant as part of the objections. Exhibit 14 the proposed risk mitigation measures. by their claim that EPA’s assessment consists of a statistical summary of Based on its revised assessment, EPA relied on ‘‘unrealistic and overly groundwater pH statistics from the explained in the final rule that it conservative assumptions.’’ Therefore, USGS NAWQA database. Means, disagreed that the criteria on the this objection, and the attendant hearing standard deviations, and numbers of September 2008 label defined 100% of request, is denied based on Petitioners’ groundwater measurements in the the conditions where ground water failure to state with ‘‘particularity * * * database are summarized by state and sources would be vulnerable to the basis for the objection * * *’’ (40 land use within each state. carbofuran leaching. EPA noted that no CFR 178.25(a)(2)). As Petitioners raised i. Background. In the proposed rule comprehensive analysis had been similar allegations in their comments, EPA concluded that drinking water provided that evaluated how the EPA has assumed that they intended to taken from shallow wells is highly Petitioners had reached this conclusion. incorporate all of the issues raised in the vulnerable to contamination in areas As discussed in greater detail in EPA’s comments on the proposed rule. where carbofuran is used around sandy, Response to Comments, the information To the extent this objection relies on acidic soil, although sites that are less provided as part of the Petitioners’ the September 2008 mitigation vulnerable (e.g., deeper groundwater, comments—primarily maps depicting measures, EPA denies the hearing less coarsely textured soils) could still areas identified as vulnerable—was not request because the evidentiary proffer be prone to have concentrations sufficient to allow the Agency to in support of this objection is exceeding acceptable exposures (73 FR evaluate their claim (Ref. 84). insufficient to warrant a hearing. The 44881–44883 (July 31, 2008)). EPA also EPA also disagreed that the record is clear on its face that EPA did described the available NAWQA commenters provided sufficient account for the mitigation measures in monitoring data, and explained the information to support their general its revised risk assessment supporting reasons that the monitoring data tends claim that only high pH conditions (pH the final rule. A hearing can only be to underestimate exposure for acute above 7) existed in all the areas in based on a genuine issue of disputed risks, such as those carbofuran presents, which carbofuran could be used under fact (40 CFR 178.32(b)(1)). Where a and so are not sufficiently robust to be FMC’s September 2008 revised label. party’s factual allegations are used as an input into a quantitative risk EPA presented its assessment of the contradicted by the record, there is no assessment or to serve as a lower bound newly submitted label in its Response to genuine dispute (73 FR 42701–42702 (73 FR 44880–44881 (July 31, 2008)). Comments document and these issues (July 23, 2008) (Denying NRDC’s hearing As part of their comments on the were addressed in substantial detail request where EPA had revised its proposed rule, FMC requested that EPA there (Ref. 84). residential exposure assessment to amend their registration to include a EPA did not evaluate the mitigation address the issue complained of); 57 FR number of geographic use restrictions measures proposed in the December 24, 6667, 6668 (February 27, 1992) (‘‘A and migitation measures intended to 2008 submission. The mitigation hearing must be based on reliable address the risks to groundwater. In measures in that submission were evidence, not on mere allegations or on their comments, Petitioners claimed that incorporated into the measures information that is inaccurate and ‘‘[g]roundwater sources are vulnerable proposed by the Petitioners as part of contradicted by the record.’’)). to carbofuran leaching only under their objections on June 30, 2009. The objection also suffers from a certain conditions, namely where ii. Denial of hearing request. EPA is further defect; many of the allegations in permeable soils (e.g., areas with soils denying the hearing requested on this this objection merely reiterate points greater than 90% sand and less than 1% objection because, in large measure, if Petitioners had raised in their earlier organic matter), acidic soil and water not entirely, it rests on the newly comments. For example, EPA addressed conditions, and shallow water tables submitted mitigation measures the claim that the NAWQA data from predominate (e.g., where ground water accompanying Petitioners’ objections. 1993–2006 rarely show detections of is less than 30 feet).’’ The commenters As discussed in Unit VI.C, EPA has carbofuran, and that in ‘‘almost every claimed that these conditions are rare in determined that these objections do not instance’’ the observed concentrations areas where carbofuran would be used warrant a hearing because they are are low. EPA also addressed the claim under the new label proposed as part of irrelevant, and therefore immaterial, to that only areas with permeable soils their comments. They further asserted EPA’s determination in the May 15, (e.g., areas with soils greater than 90% that in ‘‘most states where carbofuran is 2009 final rule that the carbofuran sand and less than 1% organic matter), used, less than 2% of the entire surface tolerances were unsafe and could not be acidic soil and water conditions, and
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where shallow water tables predominate parlance, the samples were not collected targeted to carbofuran use in areas (e.g., where ground water is less than 30 randomly. The maps in Exhibit 14 where aquifers are vulnerable, and the feet) present significant risks of clearly demonstrate that the study locations of sampling and the sampling leaching. As previously discussed, mere samples were not randomly distributed frequencies generally are not sufficient reiteration of comments made in across the state but were primarily in to capture peak concentrations of the response to the proposed rule does not the southern and eastern portions of pesticide in a watershed or aquifer provide an adequate basis for a hearing, each state, even though carbofuran use where carbofuran is used. Capturing unless the objector proffers some is not restricted to those portions of the these peak concentrations is particularly evidence calling EPA’s conclusion into states. In other words, no evidence was important for assessing risks from question (40 CFR 178.32(b)(3)). See, e.g, provided that would allow the Agency carbofuran because the toxicity end- 73 FR 42701–42702 (July 23, 2008); 53 to determine the percentage of the point of concern results from single-day FR 53176 (December 30, 1988). carbofuran use area represented by the exposure (acute effects). Pesticide The evidence submitted in Exhibits 95% of the samples the Petitioners’ concentrations in ground water are 12–14 does not cure these defects. As a analysis addressed. Nor was any generally the result of longer-term preliminary matter, much of this information provided to document the processes and less frequent sampling evidence is untimely. The analyses in significance of the remaining 5% of the can often adequately characterize peak Exhibits 12 and 13 appear to be the samples that were not captured by their ground water concentrations. However, National Leaching Assessment analysis; for example, although this may such data must be targeted at vulnerable described in Petitioners’ comments, but have only represented 5% of the aquifers in locations where carbofuran modified to account for the proposed samples, it is not clear whether this 5% applications are documented in order to amendments submitted as part of the relates to only 5% of the areas where capture peak concentrations. As a objections. As noted previously, neither carbofuran may be used, or whether it consequence, monitoring data tends to the National Leaching Assessment nor actually represent a far greater underestimate exposure for acute the model on which it was based was percentage of the use area. endpoints. submitted as part of the comments. iii. Denial of objection. EPA denies EPA also disagrees that the Certainly, there is no justification for this objection on several bases. Petitioners’ criteria of soils composed of Petitioners’ refusal to provide the The contention that the NAWQA 90% sand and less than 1% organic analyses that were available during the monitoring data—or indeed any matter, and wells of less than 30 feet comment period. Because the National available carbofuran monitoring data— define all of the conditions under which Leaching Assessment was available provide an adequate basis for ground water sources are vulnerable to during the comment period but was concluding that concentrations will carbofuran leaching. No comprehensive withheld, this information is considered remain low in the areas where use is analysis was provided evaluating how to be untimely and the Petitioners have now permitted is incorrect. The they reached this conclusion. Although waived the right to rely on it. NAWQA program focuses on ambient the Petitioners proposed these criteria as Accordingly, as discussed in Unit VI.D, water rather than on drinking water restrictions on the carbofuran label, the because this evidence was not presented sources, is not specifically targeted to spatial extent of the label restrictions as part of the Petitioners’ comments, the high use area of any specific was not provided. Moreover, as EPA considers that the evidence pesticide, and is sampled at a frequency discussed in greater detail in EPA’s submitted in support of this objection is (generally weekly or bi-weekly during Response to Comments, the information not appropriately considered as a basis the use season) insufficient to provide provided as part of the Petitioners’ for justifying a hearing on the final rule. reliable estimates of peak pesticide comments (primarily maps depicting See 73 FR 42683, 42696 (July 23, 2008); concentrations in surface water. For areas identified as vulnerable) was not 72 FR 39318, 39324 (July 18, 2007). And example, significant fractions of the data sufficient to allow the Agency to in the absence of this evidence, this may not be relevant to assessing evaluate their claim (Ref. 84). For portion of the objection consists of mere exposure from carbofuran use, as there example, the percent sand, one of the allegations and denials, which do not may be no use in the basin above the criteria used in this analysis, varies warrant a hearing (40 CFR 178.32(b)(2)). monitoring site. Unless ancillary usage significantly across a field and the But even assuming that the evidence data are available to determine the whole range of soil textures may occur was appropriately considered, the amount and timing of the pesticide at a county-level. The national map evidence is insufficient, even if applied, it is difficult to determine provided purports to represent this established, to justify the factual whether non-detections of carbofuran parameter and several others aggregated determination urged (40 CFR were due to a low tendency to move to together to identify vulnerable locations. 178.32(b)(3)). Nothing in Exhibits 12–13 water or from a lack of use in the basin. This national-scale map does not provides any information that As a consequence, the data do not provide the level of detail needed to substantively differs from the support relying on the non-detections as verify the combination of paramters at information summarized in the a lower bound, or relying on the locations identified as vulnerable. comments. Second, even assuming that detections as an upper bound. The While the assertion that soils with 90 the analysis in Exhibit 14 is valid, on its program, rather, provides a good percent sand are the most vulnerable to face the submission states that the understanding on a national level of the leaching is in part true, it is misleading. analysis only addresses 95% of the occurrence of pesticides in flowing While many states have only small areas samples chosen by the study; no water bodies that can be useful for of sandy soils, several of the states in information was provided to explain screening assessments of potential which carbofuran would continue to be how the samples relate to the state or drinking water sources, especially for used under the Petitioners’ proposals other geographic area in which those assessments concerned with have quite extensive areas. For example, carbofuran would be used. This is chronic, rather than acute toxicants. according to the Petitioners’ own important because NAWQA samples While there have been additional assessment of states with high amounts were not evenly distributed across most groundwater monitoring studies that of carbofuran application (Ref. 6), Texas states, but tended to be concentrated in included carbofuran as an analyte, there had 4.2% of soils classified ‘‘as sand’’, particular regions; in statistical has been no additional monitoring Michigan had 21.3% and Nebraska had
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26.3%. In addition, the Petitioners’ Finally, the pH in various wells may or estimates of carbofuran in ground water. statements imply that soils that are may not be statistically independent. Under more acidic conditions, the sandy textured define the universe of Samples taken across the landscape are hydrolysis half-life increases from 28 soil textures that are vulnerable to usually spatially correlated up to a days at pH 7 to years or more at pHs less leaching. It is possible that more fine- certain distance. Beyond that distance, than 6. Further, the results of EPA’s textured soils, for example sandy loams they are statistically independent. corn ground water simulations or silt loams, could also be sufficiently Unfortunately, this was not determined (bounded by the high and low pH permeable to result in carbofuran as part of this analysis. While pH is values of the aquifer system underlying leaching as it has not been established clustered across the state, there is the scenario location) showed that a how much of a reduction in leaching considerable spatial variability in pH relatively small (0.5) decrease in pH might occur as texture becomes finer. conditions for both the subsurface and from 7 to 6.5 resulted in an increase by Furthermore, finer textured soils tend to surface environments. This is especially 4 orders of magnitude in the 1-in-10- have more cracks and root channels and true for shallow ground water systems, year peak concentration of carbofuran. thus are more prone to preferential flow. where local conditions can greatly affect The ground water simulations reflect Petitioners’ claims regarding pH the quality and characteristics of the variability in pH by modeling concentrations are also incorrect. As an water. This can be seen by comparing carbofuran leaching in four different pH initial matter, their analysis fails to differences in pH values between conditions (pH 5.25, 6.5, 7.0, and 8.7), prove that pH values in all use areas counties within a state, and noting that representing the range in the Wisconsin aquifer system. The upper and lower will ensure that concentrations are even within a county individual wells bound of pH values that EPA chose for below the level of concern because the will consistently yield ground water this assessment were measured values analysis in Exhibit 14 is based on a with either above- or below-average pH from the aquifer, and the remaining two flawed statistical analysis. The values for that county. Furthermore, values were chosen to reflect common methodology on which the Petitioners even if the statistical calculations was pH values between the measured values. relied—the use of the mean minus two correct, by definition this evidence Estimated 1-in-10-year peak ground standard deviations—to estimate the 5th would not support a determination that groundwater concentrations would water concentrations at pH 7 are percentile (i.e., 95% of the samples ¥ never exceed 1.1 ppb, as 5 percent of the 1.6×10 3 ppb; however, the estimated 1- above the value) of the distribution of samples would result in concentrations in-10-year peak ground water ground water pHs in a state depends that are higher. concentration at pH 6.5 is 16 ppb, strongly on the shape of the In conducting its modeling for the nearly 4 orders of magnitude greater. distribution. This method relies on three final rule, EPA examined readily EPA explained that, because of assumptions: 1) That the data is available data with respect to ground carbofuran’s sensitivity to pH, the randomly sampled, 2) that the samples water and soil pH to evaluate the spatial Agency had concerns that any given set are normally distributed (i.e., a bell- variability of pH in Wisconsin. As part of mitigation measures would not shaped distribution), and 3) that the of the final rule, EPA explained that successfully protect groundwater source samples are independent (i.e., the ground water pH values can span a wide drinking. Data indicate that pH varies sampling locations do not share range; this is especially true for shallow across an agricultural field, and also common characteristics and are not ground water systems, where local with depth (Ref. 49). In particular, the clustered). The maps in Exhibit 14 conditions can greatly affect the quality pH can be different in groundwater than clearly demonstrate that the study and characteristics of the water (higher in the overlying soil. The upper bound samples were not randomly collected or lower pHs compared to average of the carbofuran concentrations across each state but were primarily in values). As noted even within counties estimated by EPA at pH 6.5 is much the southern and eastern portions of the in the same state, wells will consistently greater than the concentrations the states, even though carbofuran use is not yield ground water with either above- or Petitioners reported in their objections. restricted to those portions of the states. below-average pH values for that EPA’s complete assessment of the 2008 For example, Figure 1 in Exhibit 14 county. Thus, EPA concluded that revised label can be found in its clearly shows that the vast majority of average ground water pH values for a Response to Comments document and the wells sampled in North Dakota and given area do not truly characterize the these issues were addressed in more South Dakota are in the eastern half of (temporal and especially spatial) detail there (Ref. 84). the state, and in Nebraska in the heterogeneity common in most areas. For all of these reasons, the objection southern and eastern parts. Therefore The actual significance of using a single is therefore denied. the wells sampled will not be pH even if it is a 95th percentile value, c. Objection/hearing request subissue: representative of the full distribution of which as described above was not Consistency with groundwater wells in the state. On the second demonstrated to be accurately concentration in NMC–CRA. Petitioners assumption, the analysis provided by calculated, is not clear. For this reason, object that EPA’s estimates in the final the Petitioners did not determine EPA bracketed potential exposure using rule are inconsistent with the whether the distribution was normal; a range of pH values. groundwater concentration estimates the accuracy of percentiles at the tails of As further explained in the final rule, EPA developed for the NMC (CRA). the distribution, such as the 95th the considerable spatial variability in However, they do not identify any percentile, are very sensitive to the pH conditions for both the subsurface specific inconsistency, they simply accuracy of this assumption. and surface environments is significant make the general allegation. They allege Environmental data are usually not because the pH has a large effect on the that, by contrast, their assessment, normally distributed; log-normal persistence of carbofuran. This is which estimated maximum distribution is more typical (Ref. 60). If demonstrated by the results of the concentrations of 1.1 ppb, is consistent the shape of the distribution is not ground water modeling simulations with the NMC CRA. known, a non-parametric or ‘empirical’ from the South-Central Wisconsin i. Background. The NMC CRA estimation of the percentiles is better scenario, which show that what might examined carbofuran at two sites, because it does not depend on the same appear as relatively small variations in northeastern Florida and the Delmarva assumption of normal distribution. soil pH can have a significant impact on Peninsula. In Florida, concentrations
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were found to be below levels of concentration. A hearing is not reason for its assumption that 100% of concern because of high pH, but in warranted where the claim is clearly PCA in a watershed is treated is due to Delmarva, both in corn and in melon contradicted by the record (40 CFR the large uncertainties in the actual PCT scenarios EPA estimated that 90% of 178.32(b)(2)). See, e.g., 57 FR 6667 on a watershed-by-watershed basis. EPA daily concentrations could be as high as (February 27,1992) (‘‘A hearing must be developed an extensive discussion of 20.5 and 25.6 ppb, respectively. In the based on reliable evidence, not on mere the uncertainties in PCT and how they proposed and final rules, EPA cited the allegations or on information that is impact drinking water exposure modeling conducted for the NMC to inaccurate and contradicted by the assessment in its proposed rule (73 FR support its estimates. In addition, EPA record.’’); 49 FR 6672 (February 22, 44885 (July 31, 2008)), and in a used the same methodology used to 1984) (hearing denied where claim was background document previously develop the estimates for the NMC CRA, based on demonstrably false premise). provided to the SAP considering the to conduct the modeling for the iii. Denial of objection. As discussed draft carbofuran NOIC (Ref. 45). The additional crops and locations on which in the final rule and response to data are generally not available on the carbofuran use occurs. comments document, the Petitioners’ scale necessary to allow for reliable Although the Petitioners alleged that results are not consistent with the estimates of pesticide use in a their estimates were consistent with the estimates developed for the NMC CRA. watershed. Such data are generally NMC CRA in their comments on the The NMC CRA examined carbofuran at available only on a statewide basis, and proposed rule, they did not identify any two sites, northeast Florida and the if such estimates are used to account for specific inconsistency between EPA’s Delmarva Peninsula. In Florida, PCT, it will underestimate the risks for groundwater estimates for the proposed concentrations were found to be below some drinking water facilities in the rule and its estimates for the NMC CRA. levels of concern because of high pH, state, as these estimates represent only ii. Denial of hearing request. EPA but in Delmarva, both in corn and in a state-wide average. In some cases this denies the request for a hearing on this melon scenarios EPA estimated that underestimate can be substantial, subissue because there is no disputed 90% of daily concentrations could be as because usage may not be evenly factual matter for resolution. There is no high as 20.5 and 25.6 ppb, respectively. distributed across the landscape; due to dispute as to the methodology EPA used These values are greater than the 1 ppb differences in factors like pest pressure, to conduct its modeling in either that Petitioners claim is the maximum local consultant recommendations, and assessment. Petitioners have not expected 1-in-10-year peak weather, it may be much higher in some identified any specific inconsistency concentration. areas. Further, temporal uncertainties between EPA’s groundwater exposure 2. Objections relating to surface water can result in changes in use that might assessment conducted for this rule and exposure estimates—a. Objection/ be driven by weather, changes in insect the assessment conducted for the NMC hearing request subissue: Use of percent resistance over time, and changes in CRA. Instead, they rely on mere of the crop treated (PCT) in surface agronomic practices. To date, methods allegations and denials. As EPA’s water modeling. The Petitioners object that account for this uncertainty, given regulations make clear, a mere ‘‘denial’’ to the assumption in the surface water the nature of the available data, have not of an EPA position is not sufficient to assessments in the final rule that 100% been developed. EPA explained that as satisfy the standard for granting a of the crops in a watershed will be a consequence, the Agency could not hearing (40 CFR 178.32(b)(2)). Moreover treated with carbofuran. The Petitioners accurately estimate a drinking-water the question of whether EPA’s argue that actual carbofuran sales data watershed scale PCT that, when used in assessments are consistent requires the on a county basis from 2002-present a quantitative risk assessment on a application of a legal standard to demonstrate that the current carbofuran national or regional basis, standing undisputed facts, and is thus a legal or PCT is less than 4.25%. Using this PCT, alone, provides the necessary level of policy question. Hearings are not and taking into account the recently certainty to allow the Agency to appropriate on questions of law or submitted ‘‘no application buffers,’’ the confidently conclude that exposures policy (40 CFR 178.32(b)(1)). (73 FR Petitioners allege that the modeling in will meet the FFDCA section 408 safety 42696–42697) (denying a hearing on Exhibit 15 demonstrates that carbofuran standard. EPA also described the results EPA’s decision to reduce the children’s concentrations in surface water will not of a sensitivity analysis conducted using safety factor, in the absence of data from exceed 1.1 ppb, ‘‘which is below the a low PCT estimate. the endocrine screening program, on the level of concern.’’ In their comments on the proposed ground that the objection constituted a In support of this objection, the rule, the Petitioners criticized the legal issue). FDA has repeatedly Petitioners reference county level sales Agency for this assumption, arguing that confirmed that the application of a legal data that were submitted to the Agency because carbofuran is used on such a standard to undisputed facts is a on November 7, 2008, after the close of low percentage of crops nationally that question of law for which a hearing is the comment period. They also it is unrealistic to assume that such a not required. (See, e.g., 68 FR 46403, reference the use tracking system large percentage of any individual 46406 n.18, 46408, 46409 (August 5, proposed in their recent registration watershed would be treated. To support 2003) (whether facts in the record show amendments (Exhibit 2) and the their claims that the PCT would there is a reasonable certainty of no modeling contained in Exhibit 15. generally be below 4%, they referenced harm is a question of law; whether a i. Background. To conduct an county-level ‘‘use’’ data, but failed to particular effect is a ‘‘harm’’ is a assessment of a pesticide’s potential to provide either the data or methodology question of law)). contaminate surface water, EPA on which they relied until after the Neither does the claim that their estimates the percentage of farmland in close of the comment period. modeling is consistent with the NMC a watershed on which a particular crop In the final rule, EPA explained at CRA justify a hearing on this question. is grown (e.g, corn); this is referred to length the reasons that the information As EPA explained in the final rule, the as the percent cropped area (PCA). EPA provided during the comment was values estimated in the modeling then assumes that 100% of the cropped insufficient to allow the Agency to conducted for the NMC CRA are greater area is treated with the pesticide that is reliably estimate a lower PCT for than the 1 ppb that FMC claims is the the subject of the assessment. In the carbofuran. EPA did not review the maximum expected 1-in-10-year peak proposed rule, EPA explained that the information submitted after the close of
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the comment period. However, based on the comment in objections does not Agency assumes that 100% of the the information that could be gleaned present a live controversy unless the cropped area (or 100% PCT) is treated from the description in the comments, objector proffers some evidence calling with the pesticide. EPA also makes this EPA explained that the data on which FDA’s conclusion into question)). assumption due to the large they relied did not appear to be ‘‘use’’ An additional flaw in this objection is uncertainties in the actual PCT on a data, but sales data, and that both the that the proffered evidence is untimely watershed-by-watershed basis. EPA data and methodology failed to support and insufficient. Neither the proposed included an extensive discussion of the the claims made in the Petitioners’ registration amendments nor the uncertainties in PCT and how they comments. The Agency also described evidence submitted as part of this impact drinking water exposure the results of a sensitivity analysis objection, including the modeling in assessment in its proposed rule (73 FR conducted to determine the impact that Exhibit 15, was provided to the Agency 44834) and in a background document PCT could have on the risk assessment, during the comment period. The provided to the SAP considering the which demonstrated that even assuming modeling in Exhibit 15 was available, draft carbofuran NOIC (Ref. 45). Because that a low percentage of a watershed is because it was summarized in usage is often not evenly distributed treated with carbofuran, exposures will Petitioners’ comments; however the across the landscape, due to differences still be unsafe for infants. underlying modeling was withheld. in factors like pest pressure, local ii. Denial of Hearing Request. To the Equally, there is no evident reason that consultant recommendations and extent Petitioners’ objection is limited to the sales data could not have been weather, it may be much higher in some submitted as part of the Petitioners’ EPA’s refusal to use a 4% PCT in areas. Further, temporal uncertainties comments. Petitioners relied on this estimating drinking water can result in changes in use that might data to perform analyses completed in concentrations, EPA has concluded that be driven by weather, changes in insect 2006–2007, for purposes of the January the objection does not warrant a hearing resistance over time, and changes in 2008 SAP review of the draft carbofuran because the Petitioners’ objection on agronomic practices. To date, methods NOIC, so the information was available this subissue is irrelevant, and therefore that account for this uncertainty, given long before their comments needed to be immaterial, with regard to EPA’s final the nature of the available data, have not filed. Accordingly, as discussed in Unit been developed. Consequently, EPA tolerance revocation. The Petitioners VI.D, this information is not cannot accurately estimate a drinking- have not responded to EPA’s appropriately considered as a basis for water watershed scale PCT that, when explanation in the final rule of the justifying a hearing on its final rule. used in a quantitative risk assessment reasons that the information and Moreover, as explained below, because on a national or regional basis, standing methodology on which they relied to no evidence was submitted in support alone, provides the necessary level of estimate a 4% PCT was flawed. As of the newly proposed use tracking certainty to allow the Agency to discussed in the final rule, EPA had system, reliance on that proposal to confidently conclude that exposures assumed that the data on which they support a low PCT constitutes nothing will meet the FFDCA section 408 safety were relying was sales data, and so the more than an allegation. This is not an standard. resubmission of the information sent in adequate basis on which to grant a In most cases, EPA agrees that it is after the close of the comment period hearing (40 CFR 178.32(b)(2)). Finally, unlikely that 100% of the crop will be only confirms that the Agency’s analysis to the extent this objection relies on treated with a single pesticide in most was correct; it does not rebut EPA’s Petitioners’ recently proposed risk watersheds, particularly in larger substantive concern that such mitigation measures, as discussed in watersheds. However, for small information is insufficient to support Units VI.C and D, objections and watersheds, it is reasonable to assume the conclusions the Petitioners assert. In hearing requests based on these new that an extremely high percentage of the essence, the Petitioners ignored EPA’s risk mitigation measures are not crops in the watershed may be treated. extensive analysis of this issue in the appropriately considered at this stage of Moreover, EPA has an obligation to final rule and simply refiled their the administrative process, and are evaluate all legally permitted use comments on the proposal as if EPA’s denied as immaterial (40 CFR practices under the label, and to ensure determination in the final rule did not 178.32(b)(3)). that all such use meets the requisite exist. The statute, however, requires that iii. Denial of objection. While the statutory standards, not simply to base objections be filed on the final rule not Agency typically uses PCT in its decisions on the practices the the proposal. By ignoring EPA’s final developing estimates of pesticide majority might typically use. The rule on this issue, Petitioners have residues in food, this is entirely September 2008 proposed label, failed to lodge a relevant objection. different than developing estimates of submitted during the comment period, When an objector does not challenge the percent of a watershed that is treated imposes no restriction on the EPA’s conclusions in the final rule, but for purposes of estimating drinking application of carbofuran related to merely reiterates comments made on the water exposures. Food is generally whether a particular percent of the proposed rule, without submitting some randomly distributed for sale across the watershed has been treated. Thus, even evidence that calls EPA final rule nation without regard to where it is with the restrictions on FMC’s conclusions into question, the objector grown. This tends to even out any PCT September 2008 labels, it remains has not raised a live controversy as to variations that may arise on local levels. legally permissible for 100% of the an issue material to the final rule (See By contrast, the source of water watershed to be treated with carbofuran. 73 FR 42698–42699 (July 23, 2008) consumption (and consequently Nor is EPA aware of an enforceable (denying several NRDC hearing requests exposure) is localized, either in a mechanism to ensure that farmers because the objections were based on private well or a community water applying pesticide to their individual EPA’s preliminary DDVP risk system. The PCT in any watershed will fields will have the ability to assessment, rather than the revised risk therefore directly impact the residues to indendently determine whether a assessment published with the final which people living in that watershed particular percentage of the watershed order); 53 FR 53176, 53191 (December will be exposed. has been treated. There are significant 30, 1988) (where FDA responds to a For this reason, among others, for practical difficulties inherent in comment in the final rule, repetition of drinking water exposure estimation, the implementing such label directions, as
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they force individual growers to have explained what is meant by negative provided as part of the objections were continual knowledge of the variances of usage estimates. aggregated for all crops, including crops the behavior of other farmers across the The Agency agrees that county-level on which use is no longer allowed, such entire watershed. While for small use data would be useful in generating as cotton or alfala; the data were not watersheds that involve only one or two reasonable estimates of PCT that might collected based on the individual crops. farms it might be feasible for neighbors be appropriately used in drinking water No explanation is provided to indicate to independently coordinate assessments. However, no usage data how the Petitioners divided the quantity applications with respect to adjacent have been provided. Rather, the sold between the amount used on fields, for larger watersheds or for Petitioners only provided county-level cotton, on alfalfa, and on all other crops. smaller watersheds with multiple farms, use estimates for Illinois, although they Since part of the purpose of the the practical difficulties increase have not submitted the analyses that Petitioners’ assessment is presumably to significantly. And as explained below in presumably are the basis for the show that eliminating the use on the Unit VI.F.2.D, significant questions estimates. County-level estimates to cancelled crops, such as alfalfa, will remain regarding the efficacy of support other risk assessments have not sufficiently reduce any risks, it is Petitioners’ proposed use tracking been submitted by the Petitioners. critical to know how they determined system. Further, the Petitioners have provided the amount used on alfalfa as opposed However, in the final rule, EPA limited characterization of the source to other crops, and it is difficult to conducted a sensitivity analysis to data, noting that these data were derived imagine how this could be done with explore the impact of the PCT from FMC billings and ‘‘EDI data’’, but any accuracy. For example, one could assumption on dietary risk using an they did not provide either the billings assume that the chemical is used on assumed 10% PCT, a figure proposed or the EDI data, nor explain how they equal proportion of all crops, but there previously by FMC (74 FR 23065– were collected. is no basis for such an assumption. It 23066). The results of that analysis There are two major problems in might not matter if all EPA were demonstrated that even at these low equating sales information with use interested in was the total amount used information: (1) Mapping the point and percentages, which may significantly in an area, but this is not useful for time of sale to the point and time of use underestimate exposures, particularly in purposes of assessing the risk on a and (2) allocating the amount sold small watersheds, carbofuran exposures smaller scale, such as in the present across the crops on which it can be from drinking water contribute case. used. The submission did not explain significantly to children’s dietary risks. The method the Petitioners used to how either of these two problems was EPA conducted a similar sensitivity generate use estimates from the sales resolved. analysis for the final rule, discussed data does not account for the The first problem is highlighted by uncertainties described above nor for below in Unit VI.F.3, which the fact that for some county/crop/year the potential for use to be locally demonstrates that even assuming that a combinations in the submitted tables, concentrated due to pest pressures. The low percentage of a watershed is treated, estimated usage is negative. Use of a method that is summarily described as exposures will still be unsafe for infants. pesticide clearly cannot be negative, but having been used to allocate county- Since EPA’s 2006 determination that sales at a particular point and time can level usage estimates to watersheds carbofuran does not meet the safety be negative because buyers can return appears to be similar to a method that standard, FMC has submitted three unused product. The fact that some has been used by others to calculate assessments that relied in part on what usage estimates are negative suggests ‘‘best-estimate’’ county-level PCT (Ref. they refer to as ‘‘county-level usage that buyers are returning carbofuran 73) to map nationwide pesticide usage. data’’ (Refs. 29, 74, and 89). Based on product purchased in an earlier time However, these methods are not the information provided with the period or from another location. But if appropriate for calculating PCTs for objections, the original source of the farmers are returning carbofuran surface drinking water sources or ‘‘county-level usage data’’ is sales data, purchased in a previous time period, watersheds that drain to community apparently collected at the distributor any assessment must also account for water systems, because they do not level. The Petitioners claim to have the possibility that they also could use adequately account for the uncertainty augmented these sales data in an stocks purchased previously. Thus, use in the data at the appropriate spatial unspecified manner, by incorporating in a given year may be greater than sales scale. This methodology produces an information from the distributors, which in that year. Similarly, if farmers are estimate that is a measure of central was used to allocate carbofuran usage at returning carbofuran purchased in tendency and, as such, roughly half the the county level. In their comments on another location, it must be recognized estimated values will underestimate the the proposed rule, the Petitioners that they could be using carbofuran PCT. Furthermore, because pesticide provided maps representing county purchased in another location. Thus, use varies from year to year, and can in level and watershed-scale use estimates, use in any given county or watershed some cases be patchy, with high levels but did not provide the actual usage could be greater than sales in that of use in small areas and little use in estimates in any clearly understandable locality. That is, regardless of whether most areas, the underestimates of PCT format. the issue is use over space, time, or can be substantial in small watersheds. The Petitioners did submit these sales both, the results are that usage will be As previously noted, methods for data as part of their objections, but have underestimated in some localities. calculating PCT that account for these provided only a limited description of Further, zeroing out the negative values uncertainties have not been developed. how these data were collected and no will not result in appropriate estimates; Accordingly, EPA denies this objection. description of how they were actually the negative usage estimates merely b. Objection/hearing request subissue: analyzed or validated; what was make the problem manifest. Even total Results of FMC modeling. The characterized as ‘‘careful and proven sales at a point in time may Petitioners claim that the prior surface techniques to capture this data’’ were underestimate actual use. water assessments submitted to the not described. The method used to The second problem arises with the Agency demonstrated that carbofuran attribute carbofuran sales to counties allocation of product sales across the concentrations in surface water were not was not described. Nor have they crops on which it can be used. The data expected to exceed 1.1 ppb. They claim
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that these studies provide further raised. Because Petitioners ignored provided during the comment period, confirmation of the results of the new EPA’s extensive analysis of this issue in and to the extent that the detailed modeling conducted to support their the final rule, they have essentially information EPA identified as lacking in objections, which also concluded that refiled their comments on the proposal the final rule has still not been concentrations would be less than 1.1 as if EPA’s determination in the final provided, the evidence submitted in ppb. In support of this objection, the rule did not exist. The statute, however, Exhibit 15 is not appropriately Petitioners reference the previously requires that objections be filed on the considered as a basis for justifying a submitted studies, along with the final rule, not on the proposal (21 U.S.C. hearing on its final rule. And in the modeling provided in Exhibit 15. The 346a(g)(2)). By ignoring the EPA’s final absence of this evidence, this objection modeling in Exhibit 15 appears to be the rule on this subissue, Petitioners have consists of mere allegations and general modeling that was originally failed to lodge a relevant objection. denials, which are inadequate to justify summarized in their comments, but that Petitioners’ resubmission of the exact a hearing (40 CFR 178.32(b)(2)). the Petitioners withheld. The modeling same information does nothing to call Further, to the extent that this was also supplemented to account for EPA’s conclusion into question, which objection relies on the ‘‘no application the newly proposed registration is what is required to maintain their buffers,’’ or the proposed use tracking amendments submitted as part of the claim at this stage of the proceeding. system newly submitted as part of their objections. When an objector does not challenge objections to support the models’ i. Background. In their comments, the EPA conclusions in the final rule, but assumption of a low PCT, the hearing Petitioners alleged that the results of merely reiterates comments made on the request is denied as irrelevant, and their modeling showed that proposed rule without submitting some therefore immaterial, to EPA’s concentrations of carbofuran in surface evidence that calls EPA final rule determination in the May 15, 2009 final water would not exceed 1.1 ppb. The conclusions into question, the objector rule, for the reasons discussed in Unit comments referenced two surface water has not raised a live controversy as to VI.C. Petitioners are actually not assessments that they had submitted to an issue material to the final rule. (See objecting to the conclusions in EPA’s the Agency prior to the proposed 73 FR 42700–42701 (July 23, 2008) final rule; rather, they are suggesting tolerance revocation: a surface water (hearing request denied where NRDC that EPA might reach a different result assessment based on an Indiana failed to challenge EPA’s conclusion in a different factual scenario. Community Water System (CWS) (Refs. that challenged study is consistent with Objections, however, must be directed 89 and 90) and an assessment based on several other studies, but merely ‘‘with particularity [at] the provisions of the Watershed Regressions for reiterated assertions from its original the regulation or order deemed Pesticides (WARP) model. They also petition that the study is not objectionable’’ (21 U.S.C. 346a(g)(2). summarized additional surface water representative); 53 FR 53176, 53191 And, as explained below, because no modeling that had been conducted to (December 30, 1988) (where FDA evidence was submitted in support of support their comments on the responds to a comment in the final rule, the newly proposed use tracking system, proposed rule, a Nationwide repetition of the comment in objections reliance on that proposal to support a Community Water System Assessment does not present a live controversy low PCT constitutes nothing more than (Ref. 57), but did not submit the actual unless the objector proffers some an allegation. This is not an adequate modeling, or identify or describe in evidence calling FDA’s conclusion into basis on which to grant a hearing (40 CFR 178.32(b)(2)). detail the model on which they relied. question)). In the final rule, EPA explained the iii. Denial of objection. To the extent flaws in all of the Petitioners’ With respect to the modeling this objection relies on Petitioners’ assessments that caused the Agency to submitted in Exhibit 15, this evidence is newly submitted registration reject the studies’ conclusions. For the untimely. The modeling submitted in amendments, the objection is denied as two assessments that had actually been Exhibit 15 appears to be a fuller immaterial. EPA also denies the submitted to the Agency, EPA was able description of Petitioners’ National CWS remaining objections because, based on to definitively explain the flaws. With Assessment, which was described but its review of the submitted modeling, respect to the Nationwide CWS not provided as part of their comments EPA has concluded all of the modeling modeling that was summarized in their on the proposed rule. The modeling also has substantial flaws that render the comments, EPA evaluated the modeling has been revised to account for the model results invalid. EPA has based on the information it was able to newly proposed risk mitigation previously reviewed these assessments, glean from the description provided in measures. However, even with the and provided a detailed explanation of the comment discussion. greater detail provided, the information the reasons for the Agency’s ii. Denial of hearing request. A contained in Exhibit 15 still fails to conclusions, most recently, in the final hearing is denied on this subissue address many of the deficiencies EPA rule and the associated response to because EPA has concluded that identified in the final rule. For example, comments (74 FR 23060–23064, Ref. Petitioners’ objection on this issue is although some further detail has been 84). EPA’s reasoning is summarized irrelevant, and therefore immaterial, provided of how the Petitioners briefly below. with regard to EPA’s final tolerance modeled the vegetated buffer strip, the revocation regulation (40 CFR complete information EPA would need Indiana CWS Assessment 178.32(b)(3)). In the final rule, and in to assess the modeling was not EPA has previously reviewed the other rulemaking documents, EPA provided; the material provided is Indiana surface water assessment, and provided a detailed explanation of the insufficient to understand how the has provided comments on that bases for its conclusions that the simulations were performed or how the submission (Ref. 45), many of which previously submitted assessments were simulations were parameterized. Nor were reiterated at length in the final rule invalid (74 FR 23062–23064 (May 15, have the Petitioners submitted the and response to comments documents 2009)). Petitioners have not challenged inputs used in modeling estimated (74 FR 23062–23064, Ref. 84). The EPA’s explanation, nor explained how concentration from spray drift. As Petitioners originally submitted this the resubmission of the same studies discussed in Unit VI.D, because the study to demonstrate that ‘‘EPA’s addressed the substantive issues EPA modeling in Exhibit 15 was not standard index reservoir scenario
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overestimates surface water local conditions of each CWS in Indiana were developed and how they are used concentrations compared with expected by modifying the soil and weather data by the Agency has been vetted with the concentrations in actual Indiana CWS and altering the ratio of watershed FIFRA SAP (Refs. 30 and 31). The where carbofuran is used.’’ The Index drainage area to the reservoir capacity Agency has developed PCAs for four Reservoir is designed to be used as a (Ref. 89). EPA agrees that soil and major crops—corn, soybeans, wheat, screen, and as such, represents weather data can be modified to reflect and cotton—and uses a default PCA watersheds more vulnerable than most conditions at local watersheds. based on all agricultural land for of those that support a drinking water However, EPA disagrees that altering characterizing other crops. The Agency facility. It is thus protective of most the ratio of watershed drainage area to has also calculated regional default drinking water on a national basis. That, the reservoir capacity (i.e., the DA/NC) PCAs for use in characterizing regional however, does not mean that EPA is a reasonable modification. differences in drinking water exposure. believes this scenario overestimates The DA/NC parameter is associated EPA limited further development of concentrations for all drinking water with increased concentrations in PCAs for additional crops in response to reservoirs. EPA agrees that it is an drinking water reservoirs to a certain the FIFRA SAP peer review, which appropriate refinement to simulate local point. The Petitioners adjusted their concluded that the data were not and regional watersheds, and has in fact EDWCs for each drinking water facility available at the appropriate scale to do done so (Refs. 44, 46, 47, 48, and 84). by a factor representing the ratio of the so. The Petitioners’ assessment However, for the reasons discussed DA/NC for each reservoir divided by the estimated PCAs for specific watersheds below, EPA does not believe that the DA/NC for the Index Reservoir (which in Indiana, but did not provide Petitioners’ assessment demonstrates is 12). EPA does not believe this is sufficient detail in their descriptions of that carbofuran concentrations will not appropriate for two reasons. First, the how they calculated those PCAs to exceed 1.1 ppb in Indiana surface water relationship between concentrations enable EPA to assess their validity. sources of drinking water. Even and the DA/NC is not strictly linear. Regarding the statement that the Small DA/NCs imply a small watershed accepting the Indiana surface water concentrations estimated for the study combined with a large reservoir. As the assessment at face value, the estimated locations in Indiana are significantly DA/NC increases, the relative watershed 1-in-10-year peak concentrations at less than EPA estimates, EPA has size increases, and thus the runoff some facilities were as high as 6.88 determined that the Petitioners included volume going into the reservoir also μg/L, and these concentrations an adjustment factor to account for the increases. This is also means the substantially exceed the 1.1 ppb percent of a crop that is treated with reservoir’s ability to dilute the runoff concentration the Petitioners now claim carbofuran. As previously discussed, decreases; the result is that represent reasonable estimates. EPA does not believe that it is concentrations increase with an increase appropriate to base its aggregate risk The study also fails to support the in the DA/NC. However, at some point, Petitioners’ other conclusions. The the runoff volume exceeds the reservoir estimates on PCT within watersheds. study was originally intended to capacity, and rather than increasing the This is because data and/or methods are demonstrate two points: (1) That the pesticide concentration, the excess not available that would allow EPA to vulnerability of the Indiana CWS runoff flows out of the reservoir, develop PCT at the watershed scale with ‘‘brackets’’ the Index Reservoir, and (2) carrying the pesticide with it. Thus, the necessary level of confidence to that the concentrations they estimated because pesticide concentrations are not allow EPA to make a safety finding. The for these locations are significantly less linearly related to the DA/NC, it is not PCT factors that the Petitioners applied than EPA estimates. Regarding the appropriate to multiply the model would generate significantly lower vulnerability of the CWS, the output by a linear DA/NC adjustment concentrations than those estimated by assessment describes their approach for factor. Secondly, the PRZM model, EPA. modifying the parameters of the Index which is used to simulate the watershed WARP Assessment Reservoir scenario to represent 15 for the Index Reservoir, is a field-scale reservoir-based watersheds in Indiana model. As the watershed size (and the EPA has reviewed the WARP cropped in corn. The study indicates the DA/NC) increases, assumptions upon assessment previously and has provided Petitioners have included data that, which PRZM relies (namely: uniformity comments on the submission (Refs. 45 based on EPA’s review of these of soils, equal and simultaneous and 86). The WARP model has not been submissions, are not available at the movement of runoff to the reservoir, and fully evaluated for quantitative use in appropriate scale to determine all site- uniform weather across the watershed) exposure estimation by the Agency, specific parameters. The Petitioners no longer hold and the model becomes although it has been preliminarily modified some of the parameters based less valid for simulating the runoff reviewed by the SAP (Ref. 32). EPA on available data to represent more processes. The geometry of the Index used WARP to select monitoring sites localized conditions that are more or Reservoir was chosen partly to avoid for the herbicide atrazine, based on less vulnerable than for the Index these two limitations (Ref. 43). predicted vulnerability of watersheds to Reservoir. From the description, the The study authors also calculated atrazine runoff within the corn/sorghum Petitioners’ approach is similar to the their own PCA values 19 for this growing regions. EPA presented its methods that EPA uses to develop new assessment. EPA uses the maximum approach to the FIFRA SAP in scenarios, in that soil and weather data PCA calculated for any HUC8 (8-digit December 2007. The SAP report are varied in order to represent different hydrologic unit code) watershed in concluded that ‘‘WARP appears to be a locations. However, for other exposure estimates. HUC8s are logical approach to identify the areas of parameters, EPA believes the cataloging units for a watershed high vulnerability to atrazine exposure,’’ modifications are inconsistent with developed by the USGS and are used as endorsing EPA’s use of this tool only for fundamental assumptions upon which surrogates for drinking water atrazine, and for the limited purpose of the modeling is based. In previous watersheds. The process by which PCAs designing a monitoring program. The submissions to the Agency, FMC has SAP noted that the most important described that they have made 19 The PCA is the fraction of the drinking water explanatory variable with WARP was modifications to scenarios to reflect watershed that is used to grow a particular crop. use intensity, which underscores the
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importance of having the most accurate The Agency also disagrees that the estimate county level use estimates from data for this parameter. differences between the Petitioners’ and the sales data was not provided. The WARP is a regression model EPA estimates are only due to county level estimates used in the developed by the USGS to estimate Petitioners’ use of county-level use assessment for 2002 to 2004 for Illinois concentrations of the pesticide atrazine estimates. Most importantly, the were provided in a table. These in rivers and streams. As a regression Petitioners relied on estimates of 1-in- estimates for each county were averaged model, it is based on monitoring data 10-day concentrations, rather than the 1- over the 3 years for input to the model. from 112 USGS NAWQA monitoring in-10-year peak concentrations A summary description of how locations. WARP does not directly estimates used routinely by EPA. 1-in- watershed-scale use estimated from estimate daily concentrations, but 10-day concentrations are not the county level use data was provided, but predicts the percent of the time in a measurement endpoint EPA uses for because the sales data for the individual randomly selected year that human health risk assessment and are crops and the method that was used to concentrations of the pesticide are less not appropriate for estimating drinking generate county level estimates were not than a specified value, with a specified water exposure. The Agency uses 1-in- available, the validity of this assessment level of confidence. USGS attempted to 10-year peak concentrations for cannot be evaluated. screening level assessments, and the full develop an approach to estimate annual Nationwide CWS Assessment time series for other pesticides, and time series (typically 30 years) of daily concluded that ‘‘further data collection concentration values for refined EPA has previously reviewed the and model development may be assessments. EPA’s reliance on the 1-in- Petitioners’ ‘‘Nationwide CWS necessary to determine whether the 10-year peak concentration has been Assessment’’ and provided a response to model should be used for areas for reviewed and approved by the FIFRA the submission as part of the final rule which fewer historical data are available SAP (Ref. 30). and Response to comments (Ref. 45). As * * * Because of the relative simplicity A concentration that occurs 1-in-10 a preliminary matter, this assessment of the time-series model and because of days occurs 350 times as often as a 1- only included use intensity for the inherent noise and unpredictability in-10-year event. Using this value reservoir-based systems, and excluded of pesticide concentrations, many instead of the one EPA used would use intensity for all stream- or river- limitations of the model need to be result in significantly lower estimates of based systems from their assessment. considered before the model can be pesticide water concentration and Therefore, this assessment provides no human exposure. For example, EPA’s used to assess long-term pesticide evidence to demonstrate that carbofuran estimate of the 1-in-10-year peak exposure risks’’ (Ref. 92). can be safely used in stream or river- concentration from the simulation of based community water systems. The Petitioners had previously relied corn in Kansas with a 300 ft buffer was Similar to the Indiana CWS study on their WARP assessment to support 31.8 ppb. By contrast, EPA’s estimate of discussed above, this study relied on the conclusion that the ‘‘maximum 1-in- the 1-in-10-day concentration from the county-level usage estimates to estimate 10-day estimated concentrations of same simulation was 4.5. Use of the 1- use intensity. The National CWS carbofuran at the 90th percentile level in-10 day concentration to assess dietary Assessment concluded that a use in Illinois, Indiana, Iowa, and Nebraska risk would be inconsistent with the intensity below 2.1 lbs a.i/mi2 would * * * will be less than or equal to SAP’s advice and EPA’s typical practice, 0.3687 ppb.’’ This is erroneous. WARP as well as with EPA’s statutory assure that surface water concentrations does not provide direct estimates of requirement to protect human health. will be below the level of concern. return frequency, i.e., 1-in-10 days, but EPA disagrees with the Petitioners’ To evaluate the study, it is therefore rather percentiles of the expected claim that ‘‘the extreme nature of a 1- important to understand how the use distribution of measurements. This may in-10-year event would result in intensities were derived. The be similar but not identical to the return dilution effects that cancel out any Petitioners’ methods have been poorly frequency expressed as a percentile, increased loading.’’ The Index Reservoir described, but EPA has been able to depending on the number of scenario has been validated against piece together a general sense of the measurements used to support the monitoring collected at the site it was methods from the various reports regression. EPA lacked the information designed to represent, Shipman City provided to EPA. To summarize, the necessary to determine whether the Lake in Illinois (Ref. 43). This Petitioners relied on sales data to contractor calibrated the model assessment showed that the 1-in-10-year generate the use intensity estimates, but correctly. However, taking the event EPA modeled was similar in the method used to generate the county- conclusion at face value, the value the magnitude to the peak value of the level use estimates from the sales data Petitioners predicted using WARP, pesticide concentrations shown in 5 is not described. The actual county level 0.3687 ppb, appears to represent the years of monitoring data collected at use estimates used in the use intensity maximum of the estimated values of the that site. The 1-in-10-year peak calculations were not provided. There is annual 90th percentile among all the concentration calculated for that a limited description indicating only sites evaluated. Such a site would be pesticide (not carbofuran), using the that the county level use estimates were expected to have higher concentrations Index Reservoir was 33 ppb, while the apportioned to different crops, but the than 0.3687 ppb about 37 days a year peak value from 5 years of monitoring method used to do this was not (10% of the year). Generally, the 90% was 34 ppb. provided. The Petitioners appear to prediction intervals tend to be about EPA cannot determine the validity of have used an objective method to group plus or minus an order of magnitude. the use intensities assumed for the the county-level use estimates into 5 Thus, roughly 5% of such sites could Petitioners’ assessment. The source of classes, but the method is only briefly have about 37 days a year greater than county level use data appears to have described. Thus, because EPA cannot about 3.7 ppb, or over 3-fold higher than been sales data at the distributor level, determine how use intensity was the 1.1.ppb concentrations the similar to the data provided in the estimated, the Agency cannot determine Petitioners now claim will be the Petitioners’ November 7, 2008 if the conclusions made in the National maximum concentrations in surface submission. However, as previously CWS Assessment are justified by the water. explained, the method chosen to underlying data.
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In the absence of this information, estimated exposures will substantially In support, they claimed that EPA is unable to substantiate the study exceed safe levels. These results are ‘‘carbofuran was once used at several conclusion that 75% of the permissible described in more detail in Unit V.E. of nurseries and strawberry farms in the use areas have a carbofuran use this order, the final rule, and Reference Zollner Creek watershed at estimated intensity below 2.1 lbs a.i/mi2—even 84, Appendix I. For all of these reasons, application rates of up to 15 lbs. a.i./ assuming that reliance on only 75% of the objection is denied. acre (5 times higher than the maximum the use areas would be protective, and c. Objection/hearing request subissue: rate on the current label, and 15 times nothing has been submitted to Challenges to EPA use of NAWQA higher than the most common use substantiate that conclusion. Use monitoring data. The Petitioners object rates)’’ (Id at 56). intensity maps that were provided with to EPA’s discussion in the final rule of In the final rule, EPA explained that the Petitioners’ comments appear to the extremely high concentrations it had not relied solely on Zollner Creek indicate that carbofuran use varies year detected in Zollner Creek in Oregon. concentrations to validate its modeling. by year, and it is not clear for which They argue that reliance on these EPA again described the results of all year or years, the Petitioners are relying concentrations to confirm the results of available modeling, which included the to support their claim that use intensity EPA’s modeling is not supportable detections at Zollner Creek, but also will be below 2.1 lbs a.i/mi2. No further because Zollner Creek is a small isolated included results from all other NAWQA support for this claim was provided creek, not a drinking water source, and sites, SDWA post-treatment monitoring, with the Petitioners’ objections, even that because of its size, is not and the results of field studies. Based on though EPA presented its conclusions in representative of potential drinking all of these data, EPA concluded that the the final rule. water anywhere else. They also argue results of the revised modeling As noted, the National CWS that the majority of the concentrations conducted for the final rule was Assessment assumed that a use intensity in the NAWQA data, including those consistent with the available monitoring below 2.1 lbs a.i/mi2 would assure that detected at Zollner Creek, are extremely data. surface water concentrations will be low—below the 1.1 ppb they claim is ii. Denial of hearing request. This below the level of concern. EPA agrees supported by their modeling. They also subissue does not meet the standard for that using lower rates of carbofuran will contend that the higher observed a hearing. The objections regarding result in lower exposure. But EPA does concentrations in the NAWQA Zollner Creek are not material. EPA did not agree that it has been demonstrated monitoring data are the result of use not rely in on the concentrations that a use intensity below 2.1 lbs a.i./ patterns that are no longer permitted, detected at Zollner Creek to provide mi2 will assure that surface water and that allowed a much higher use rate significant support its assessment. concentrations will be below the than is currently permitted. In the final rule, EPA was clear that applicable level of concern. The i. Background. In the proposed rule, it considered the levels seen at Zollner National CWS Assessment does not EPA described the available monitoring Creek to be a rare circumstance: justify such a finding, nor has any other data that characterized carbofuran While available monitoring from other assessment that has been submitted to concentrations in surface water. EPA portions of the country suggests that the date. The Agency modeled use rates for described that the highest circumstances giving rise to high carbofuran on corn based on the label concentrations of carbofuran are concentrations of carbofuran may be rare, proposed in September 2008, which are reported from a sampling station on overall, the national monitoring data indicate the rates at which farmers are legally Zollner Creek, which EPA that EPA cannot dismiss the possibility of allowed to apply carbofuran, and the acknowledged ‘‘is not directly used as a detectable carbofuran concentrations in some results clearly demonstrate that drinking water source’’ (73 FR 44883). surface waters under specific use and environmental conditions. estimated exposures will substantially USGS monitoring at Zollner Creek from exceed safe levels. The results of EPA’s 1993 to 2006 detected carbofuran (74 FR 23081). The final rule was clear assessments are described in more detail annually in 40–100% of the samples. that EPA placed greater reliance on the in Unit V.E. of this order, the final rule EPA stated that although the majority of concentrations detected in Safe and in Reference 111. the concentrations detected were in the Drinking Water Act (SDWA) post- EPA is equally unable to confirm the sub-part per billion range, treatment monitoring, showing study’s claim that the no-application concentrations have exceeded 1 ppb in concentrations ranging between 4 and 7 buffers on the September 2008 labels 8 of the 14 years of sampling (Id.). The ppb (74 FR 23079–23080). EPA also will adequately mitigate the risks ‘‘in maximum measured concentration was discussed the results of the UK tile areas with historical use intensities 32.2 ppb, observed in the spring of drain studies as supplemental greater than 2.1 lbs a.i./sq. mi.’’ On the 2002. EPA compared its modeling confirmation of its modeling (74 FR September 2008 labels, FMC included results to the concentrations seen in all 23082). buffers of 300 feet on water bodies in of the USGS monitoring, Safe Drinking Petitioners’ contentions regarding the Kansas, and 66 feet around water bodies Water Act (SDWA) monitoring, and to NAWQA monitoring also fail to present in other places, but EPA cannot evaluate the results of the available field scale a genuinely-disputed issue of material how these buffers relate to areas where studies. EPA concluded that the fact. In both the proposed and final carbofuran use intensities exceeded a concentrations estimated in its rules, EPA acknowledged the large specific value, for all of the reasons modeling were consistent with the percentage of non-detections and low stated above. EPA did, however, model results of all of the available monitoring concentration levels in the majority of the effects from the buffers proposed on and studies (73 FR 44883–44884). the NAWQA monitoring data, and the September 2008 labels and found In their comments on the proposed repeatedly explained the reasons that that these buffers reduce exposure by rule, the Petitioners alleged that these data cannot serve as lower or 5.1% (33.5 to 31.8 ppb) for corn in comparisons between EPA’s modeling upper bounds (73 FR 44882–44883; 74 Kansas with a 300-foot spray drift buffer concentrations and Zollner Creek FR 23081). Petitioners do not dispute and 4.7% (29.9 to 28.5 ppb) for corn in detections were inappropriate because those conclusions, or submit evidence Texas with a 66-foot spray drift buffer. they were based on ‘‘older data [that] are to rebut them. When an objector does However, even with the buffers, EPA’s not reflective of future carbofuran use not challenge EPA conclusions in the analyses clearly demonstrate that areas and/or intensities’’ (Ref. 18 at 55). final rule, but merely reiterates
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comments made on the proposed rule, To further characterize carbofuran amend its existing registration to without submitting some evidence that concentrations in surface water (e.g., incorporate a requirement intended to calls EPA final rule conclusions into streams or rivers) that may drain into ensure that no more than 2% of any question, the objector has not raised a drinking water reservoirs, EPA analyzed watershed will be treated with live controversy as to an issue material the extensive source of national water carbofuran. Petitioners allege that these to the final rule. (See 73 FR 42700– monitoring data for pesticides, the new use restrictions will ensure that 42701 (denying hearing request where USGS NAWQA program. The NAWQA drinking water concentrations will not NRDC failed to object to the basis EPA program focuses on ambient water exceed 1.1 ppb. In support, the asserted in its petition denial for rather than on drinking water sources, is objection presents a June 30, 2009 letter rejecting their original challenge). not specifically targeted to the high use describing the restrictions, along with Finally, no evidence has been submitted area of any specific pesticide, and is proposed revisions to the carbofuran to support the contention that all of the sampled at a frequency (generally labels. higher concentrations exclusively result weekly or bi-weekly during the use i. Background. On June 30, FMC from uses or higher use rates that are no season) insufficient to provide reliable requested that EPA amend its longer permitted. Hearings will not be estimates of peak pesticide registration to incorporate a requirement granted on mere allegations (40 CFR concentrations in surface water. For that, within five days of applying the 178.32(b)(2)). example, significant fractions of the data product, all applicators report to FMC iii. Denial of objection. Data compiled may not be relevant to assessing the following information: the location in 2002 by EPA’s Office of Water show exposure from carbofuran use, as there that the product will be used; crop, use that carbofuran was detected in treated may be no use in the basin above the rate, application method, acreage, and drinking water at a few locations. Based monitoring site. Unless ancillary usage quantity applied. Based on this on samples collected from 12,531 data are available to determine the information, FMC would track the ground water and 1,394 surface water amount and timing of the pesticide percentage in each watershed. source drinking water supplies in 16 applied, it is difficult to determine ‘‘Whenever it appears that carbofuran states, carbofuran was found at no whether non-detections of carbofuran has been applied to 1.75% of any public drinking water supply systems at were due to a low tendency to move to watershed,’’ the registrant would report concentrations exceeding 40 ppb (the water or from a lack of use in the basin. that information immediately to EPA, MCL). Carbofuran was found at one The program, rather, provides a good ‘‘cease further sales in any county that public ground water system at a understanding on a national level of the overlaps with such a watershed for that concentration of greater than 7 ppb and occurrence of pesticides in flowing use season, and shall attempt to recall in two ground water systems and one water bodies that can be useful for all unused carbofuran within such surface water public water system at screening assessments of potential counties by offering to repurchase such concentrations greater than 4 ppb drinking water sources. unused product’’ (Exhibit 3). In (measurements below this limit were The national monitoring data indicate addition, FMC requested that its not reported). Sampling is costly and is that EPA cannot dismiss the possibility registration be amended to require that conducted typically four times a year or of detectable carbofuran concentrations ‘‘based on watershed boundaries, FMC less at any single drinking water facility. in some surface waters under specific * * * prior to each uses season, allocate The overall likelihood of collecting use and environmental conditions. Even to its distributors in a manner which samples that capture peak exposure given the limited utility of the available will attempt to ensure that no events is, therefore, low. For chemicals monitoring data, there have been distributor receives more for carbofuran with acute risks of concern, such as relatively recent measured for sale than can be accommodated by carbofuran, higher concentrations and concentrations of carbofuran in surface the 2% watershed area cap in any resulting risk is primarily associated water systems at levels above 4 ppb and watershed supplied by that distributor.’’ with these peak events, which are not levels of approximately 1 to 10 ppb ii. Denial of hearing request. EPA likely to be captured in monitoring measured in streams representative of denies this hearing request on two unless the sampling rate is very high. those in watersheds that support grounds. First, discussed in VI.C, Unlike drinking water derived from drinking water systems (Ref. 81). Based Petitioners’ objections and hearing private ground water wells, drinking on this analysis, and since monitoring requests are denied as irrelevant, and water from public water supplies programs have not been sampling at a therefore immaterial, to EPA’s (surface water or ground water source) frequency sufficient to detect daily-peak determination in the May 15, 2009 final will generally be treated before it is concentrations that are needed to assess rule that the carbofuran tolerances were distributed to consumers. An evaluation carbofuran’s acute risk, the available unsafe and could not be sustained under of laboratory and field monitoring data monitoring data, in and of themselves, FFDCA section 408. Petitioners are indicate that carbofuran may be are not sufficient to establish that the actually not objecting to the conclusions effectively removed (60–100%) from risks posed by carbofuran in surface in EPA’s final rule; rather, they are drinking water by lime softening and drinking water are below thresholds of suggesting that EPA might reach a activated carbon; other treatment concern. Nor can the non-detections in different result in a different factual processes are less effective in removing the monitoring data be reasonably used scenario. Objections, however, must be carbofuran (Ref. 81). The detections to establish a lower bound of potential directed ‘‘with particularity [at] the between 4 and 7 ppb, reported above, carbofuran risk through this route of provisions of the regulation or order represent concentrations in samples exposure. Nevertheless, these results are deemed objectionable’’ (21 U.S.C. collected post-treatment. As such, these consistent with the results of EPA’s 346a(g)(2)). Further, as discussed in levels are of particular concern to the surface water modeling (Refs. 12, 47, Unit VI.D, this objection is untimely, Agency. An infant who consumes a 67). For all of these reasons, the because it was not raised in comments. single 8-ounce serving of water with a Petitioners objection is denied. Neither this specific proposal, nor any concentration of 4 ppb, as detected in d. Objection/hearing request subissue: other proposal regarding a potential the monitoring, would receive New label restrictions and revised terms tracking system, was presented to EPA approximately 130% of the aPAD from of registration. As discussed in Units by the close of the September 29, 2008 water consumption alone. VI.C and D, FMC submitted a request to comment period. EPA therefore
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considers this issue waived, and will distributors in particular watersheds with each individual NMC chemical in not consider this as an appropriate basis rests on an assumption that farmers order to more accurately account for the for justifying a hearing on its final rule. always purchase products from a likelihood of pesticide co-occurrence at However, there is a further equally distributor within their watershed. It a single drinking water facility. Thus, material defect in this hearing request. also assumes that growers and the only question is whether EPA’s basis The Petitioners have submitted no distributors will accept FMC’s offer to for adopting a different approach evidence to support their allegation that repurchase unused stock of the between the assessment of a single these proposed requirements would be products, rather than seeking to chemical’s aggregate exposure and the effective in ensuring that carbofuran stockpile the product for use in the next assessment of the cumulative exposures would be applied to no more than 2% growing season. from several chemicals is reasonable. of any watershed. The only submission In the absence of any evidence to This question requires the application of was the description provided in the demonstrate the efficacy of these a legal standard to undisputed facts. June 30 letter (Exhibit 3), and repeated proposed restrictions, any objection Hearings are not appropriate on above. However, this vague description based on these proposed amendments questions of law or policy (40 CFR leaves several critical questions constitute no more than mere 178.32(b)(1)); (73 FR 42706–42707 (July unanswered. For example, the critical allegations or denials. Hearings will not 23, 2008)). FDA has repeatedly component of this proposal is a post-use be granted on such a basis (40 CFR confirmed that the application of a legal reporting scheme, with a five-day delay 178.32(b)(2)). standard to undisputed facts is a between use and reporting. Even iii. Denial of objection. For the question of law for which a hearing is assuming that one accepts that reporting reasons discussed above, even if it were not required. (See, e.g., 68 FR 46403, an address would allow for complete appropriate to consider the proposed 46406 n.18, 46408, 46409 (August 5, identification of the location within an registration amendments, EPA is unable 2003) (whether facts in the record show individual watershed—a point on which to conclude that those amendments there is a reasonable certainty of no no evidence has been submitted—no would ensure that concentrations of harm is a question of law; whether a evidence, or even an explanation, has carbofuran in drinking water derived particular effect is a ‘‘harm’’ is a been provided to demonstrate how this from surface water will not exceed 1.1 question of law)). after-the-fact reporting requirement will ppb. Accordingly, the objection is In addition, Petitioners have not prevent application to greater denied. challenged the substance of EPA’s percentages of the watershed. For e. Objection/hearing request subissue: smaller watersheds, as discussed in the Consistency with NMC surface water response to their comments or final rule, application to only one or two estimates. Petitioners object to EPA’s submitted evidence that calls the farms may be sufficient to substantially surface water exposure estimates on the substance of EPA’s conclusions into exceed 2% of the watershed. In such ground that they are inconsistent with question (40 CFR 178.32(b)(3)). cases, since applicators are only the estimates EPA developed for Consequently, the Petitioners’ objection required to report within five days after purposes of the NMC CRA. Petitioners on this issue is irrelevant, and therefore application, it is likely that FMC would further claim that their revised surface immaterial, with regard to EPA’s final not be informed until after the 2% cap water assessment is consistent with the tolerance revocation regulation because had been exceeded. Further, there will EPA estimates in the NMC cumulative Petitioners ignored EPA’s extensive inevitably be some delay between risk assessment. The evidence proffered analysis of this issue in the final rule FMC’s attempt to repurchase the for this objection consists of the and essentially resubmitted their product and the reports suggesting (or modeling in Exhibit 15. comments on the proposal as if EPA’s confirming) that the cap either has been i. Background. In comments on the determination in the final rule did not or will shortly be exceeded. Given the proposed rule, the Petitioners exist. The statute, however, requires that inevitable delay, it is not unlikely that complained that as part of the NMC objections be filed on the final rule, not further application would occur before CRA, EPA relied on actual ‘‘county-or on the proposal (21 U.S.C. 346a(g)(2)). FMC could even attempt to repurchase multi-county level pesticide use By ignoring the EPA’s final rule on this the product. No details whatsoever have information, based on agricultural subissue, Petitioners have failed to been provided regarding the timing or chemical use surveys’’ to develop its lodge a relevant objection. Both EPA mechanism by which this would occur. estimates of potential exposure, rather and FDA precedent make clear that Further, this program operates in the than assuming 100% PCT.’’ In the final when the agency substantively responds absence of any enforceable use rule, EPA provided a lengthy and to comments on the proposal, the restriction, and no description of the detailed explanation of the reasons that commenter may only keep that issue means by which this would be enforced its approach to assessing individual alive in its objections by addressing the is provided. Although the company chemicals and its approach to assessing agency’s substantive response. See 73 would ‘‘attempt to recall the product’’ or the cumulative risks of multiple FR 42698–42699 (When an objector make it less available by ‘‘attempting’’ to chemicals differed (74 FR 23067–23068 does not challenge EPA conclusions in direct sales to particular (May 15, 2009)). the section 408(d)(4)(iii) order but rather distributorships, in the absence of some ii. Denial of hearing request. To the challenges some prior conclusion that mechanism to prevent sales or use, such extent Petitioners base this objection on was superseded by the section as a permitting process, there is no real the concerns raised in their comments, 408(d)(4)(iii) order, the objector has not assurance that these voluntary measures EPA denies the hearing request on this raised a live controversy as to an issue would be effective (Exhibit 3). This is subissue because there is no disputed material to the section 408(d)(4)(iii) further complicated by the extremely factual matter for resolution at a order; 53 FR 53176, 53191 (December low percentages contemplated by this hearing. There is no dispute that EPA 30, 1988) (where FDA responds to a proposal. assumed 100% PCT for carbofuran in its comment in the final rule, repetition of Additionally, this scheme rests on a surface water modeling, nor that EPA the comment in objections does not variety of assumptions that no evidence developed lower estimates in the NMC present a live controversy unless the has been submitted to substantiate. For CRA, that accounted for the percent of objector proffers some evidence calling example, the proposal to restrict sales to the crop that was likely to be treated FDA’s conclusion into question)).
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To the extent this objection is simply of the practices permitted under the reasonable for a single chemical an allegation that the results of the label will affect drinking water assessment to incorporate conservative modeling are consistent with the surface exposures, because all are legally assumptions to reflect reasonable worst- water estimates in EPA’s NMC risk allowed, and farmers may choose any of case exposure estimates. But in a assessment, the hearing request also them based on their particular cumulative risk assessment, the suffers from a fatal flaw. The modeling individual local conditions. This means incorporation of such conservative is based on the assumption the recently that even if growers, on a national or assumptions would imply multiple proposed label restrictions are effective, regional basis, do not frequently use a simultaneous reasonable worst-case and that the PCT will be 2%. Because particular practice, EPA must still exposure estimates for each individual the objection and hearing request are evaluate whether aggregate exposures chemical. This is so unlikely that the inextricably intertwined with the from that practice would be safe because results would no longer represent even Petitioners’ newly submitted proposed the practice is legally permissible and a reasonable worst-case estimate of the FIFRA registration amendments, the may be used due to local conditions. likely risks. Consequently, some of the objection and hearing request are denied Thus, for example, even if most growers conservative assumptions appropriately as irrelevant, as discussed in Unit VI.C. tend to apply the chemical only to a used in the single chemical risk Further, as discussed, no evidence was portion of the field, or typically only assessments are not appropriate or submitted to support the assumption apply one-half of the maximum reasonable for use in a cumulative risk that the newly submitted use tracking application rate, EPA must determine assessment, and vice versa. proposal will be effective. The only whether use by all or some growers on As a result, EPA chose in the NMC to evidence submitted in this regard is the the entire field or at the maximum rate work with those data that most closely results of the modeling in Exhibit 15, in a local watershed would result in reflect ‘‘representative’’ exposures, and which as previously discussed is unsafe drinking water concentrations. developed ‘‘representative’’ estimates of untimely, and therfore provides an By contrast, it is not feasible to PCT in regional watersheds. However, inappropriate basis for a hearing. This conduct the identical analysis for a to be clear, the PCT values used in the evidence, therefore, on multiple cumulative assessment of related NMC assessment do not represent grounds is insufficient to support a chemicals. Since the potential estimates of 50% of watersheds, or even reasonable possibility that the issue will combinations of variations in pesticide the ‘‘average’’ watershed; rather, they be resolved in the Petitioners’ favor. No use practices for the group of pesticides represent values that are expected to be hearing is warranted under such to be assessed are essentially infinite, as likely to be accurate as not, based on circumstances (40 CFR 178.32(b)(2)). even with computer modeling it would a random selection of watersheds. A iii. Denial of objection. While it is true be impossible to model or evaluate all comparable example is the statistic that that in the NMC assessment EPA used of the combinations allowed under the the average American family has PCT numbers to estimate the cumulative labels. EPA therefore needed to narrow approximately 2 children; this may or exposure from the contamination of its evaluation of the possible may not be true for any individual such pesticides in surface water, this combinations to those deemed ‘‘likely’’ family, but there is an equally good was done in order to more accurately to occur. In contrast to the single chance that it will be accurate for any account for the likelihood of pesticide chemical assessment, a cumulative randomly selected family, as that it will co-occurrence at a single drinking water assessment is intended to develop a not be accurate. For the cumulative facility. But this does not mean that use snapshot in time of what is likely assessment, EPA is able accept this level of PCT is appropriate in conducting an occurring at the moment. Moreover, the of uncertainty in these estimates, assessment of aggregate exposure from purpose of a cumulative assessment is precisely because it has confidence that carbofuran residues in surface water. to identify major sources of risk that aggregate exposures from the individual This difference in approach between the could potentially accrue due to the chemicals will be safe, based on the assessment of a single chemical’s concurrent use of several pesticides that level of conservatism in the single aggregate exposure, and the assessment act through a common mechanism of chemical assessments. But given the of the cumulative exposures from toxicity. Thus, EPA is primarily statute’s mandate to ensure a several chemicals, stems from the interested in the subset of circumstances ‘‘reasonable certainty of no harm,’’ EPA differences in the purpose and scope of in which residues from such pesticides could not rely on the approach used the two assessments. These differences occur concurrently (or co-occur). under the cumulative assessment in the inevitably require the application of In addition, one of the important absence of the more conservative single- different methodologies. attributes of a cumulative risk chemical assessment that evaluates the In evaluating the acute risks assessment is that its scope and full range of exposures permitted by the associated with a single chemical’s complexity can potentially lead to registration. contamination of drinking water, EPA inflated estimates of risk due to Nevertheless, as discussed in the final must consider all of the variations compounding conservatisms, which rule, in response to FMC’s concerns permitted under the label. Drinking would reduce the interpretability and EPA performed a sensitivity analysis of water exposures are driven by uniquely ultimately the utility of the assessments. an exposure assessment using a PCT in local factors; not only is the source of Because many data sets need to be the watershed to determine the extent to drinking water local (i.e., a person combined, reducing the impact and which some consideration of this factor drinks water from his or her local water likelihood of compounding conservative could meaningfully affect the outcome system, not from a combination of water assumptions and over-estimation bias of the risk assessment. The results systems from across the United States), becomes very important in constructing suggest that, even at levels below 10% but the likelihood and degree of a reasonable cumulative risk CT, exposures from drinking water contamination of any particular, local assessment. derived from surface waters can drinking water source, whether it is a When little or no information is contribute significantly to the aggregate reservoir or well, varies widely based on available to inform potential sources of dietary risks, particularly for infants and local conditions (e.g, from local pest exposure, such as a reasonable or children. Accordingly, these pressures, weather). Given this local maximum watershed scale PCT, it is assessments suggest that use of a variability, EPA must evaluate how all both scientifically and legally reasonably conservative PCT estimate,
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even if one could be developed, would immaterial, as discussed in Unit VI.C. that the ‘‘given the similarity between not meaningfully affect the carbofuran Petitioners are actually not objecting to these states and the other High Plains risk assessment, as aggregate exposures the conclusions in EPA’s final rule; states, it is reasonable to extend the would still exceed 100% of the aPAD. rather, they are suggesting that EPA observations from Colorado (CO), f. Objection/hearing request subissue: might reach a different result in a Nebraska (NE), and North Dakota (ND)’’ Natural surface water pH conditions. different factual scenario. Objections, (Exhibit 16 at 4). Although the ‘High The Petitioners contend that the low however, must be directed ‘‘with Plains’ states all have extensive areas of PCT levels guaranteed by the recent particularity [at] the provisions of the grassland, they also have extensive proposed use tracking system, along regulation or order deemed geographic soil and climatic with natural surface water pH objectionable’’ (21 U.S.C. 346a(g)(2)). In differences—e.g. the Black Hills and conditions in the areas where use is addition, for the reasons discussed in Badlands (SD), Sand Hills (NE), Flint permitted under the revised label will Unit VI.D, any hearing request premised Hills, Cheyenne Bottoms and Quivira ensure potential exposures are de on the new mitigation measures is wetlands (KS), Red Hills and Cross minimis. In support they reference the considered untimely, and not Timbers region (OK). These differences analysis in Exhibit 16, which they claim appropriately considered at this stage of are not surprising since the distance demonstrates that the NAWQA USGS the administrative process as a basis for from the Canadian border in ND to OK data show that average surface water pH granting a hearing under the FFDCA. is over 1000 miles. Consequently it is is above 7.5 and that ‘‘in most regions, EPA is also denying the requested not reasonable to extend observations moving 2 standard deviations away hearing on the grounds that the from CO, NE, and ND to KS, OK, and from average (which would capture evidence, even if established, is SD. 95% of all observed values) results in insufficient to justify the action urged g. Objection/hearing request subissue: pHs that are still greater than 7.5.’’ (40 CFR 178.32(b)(3)). The analyses Effect of existing drinking water i. Background. In the proposed rule, presented in Exhibit 16, as the treatment systems. The Petitioners EPA explained that the variation in pH Petitioners explicitly acknowledge, only contend that a review of drinking water across the landscape was a significant capture 95% of the values; five percent treatment systems in areas under uncertainty in EPA’s analysis. The of exposures are not, per se, de minimis. revised labels indicates that the majority proposal stated, that ‘‘while it is well Second, just as with the groundwater of the ‘‘total population in affected established that carbofuran will degrade pH analyses presented in Exhibit 14, no states obtain their drinking water from at higher rates when the pH is above 7, information was provided to explain surface water sources subject to lime and lower rates when below pH 7, due how the samples relate to the state or softening or activated charcoal filters. to the high variation of pH across the other geographic area in which They allege that ‘‘60% of the total country for many of the scenarios, a carbofuran would be used. This is population in affected states’’ will have neutral pH (pH 7) default value was important because NAWQA samples their water treated by methods that will used to estimate water concentrations were not evenly distributed across most substantially reduce or entirely remove (73 FR 44883). Petitioners raised no states, but tended to be concentrated in carbofuran concentrations. For the issue regarding surface water pH in their particular regions; in statistical remaining 40%, they claim that a comments. parlance, the samples were not collected significant portion use ground water ii. Denial of hearing request. EPA randomly. In other words, no evidence sources, which are already protected by denies this hearing request because the was provided that would allow the the Petitioners’ other mitigation objection, as well as the proffered Agency to determine the percentage of measures, and the remainder are evidence is untimely. EPA clearly the carbofuran use area represented by protected by the Petitioners’ proposed described the potential impact that pH the 95% of the samples the Petitioners’ use reporting scheme. In support of this could have on its estimates, and noted analysis addressed. Nor was any objection, Petitioners rely on the that this was a significant uncertainty in information provided to document the analysis in Exhibit 17. its assessment. None of the analyses in significance of the remaining 5% of the i. Background. In the proposed rule, Exhibit 16 were provided as comments samples that were not captured by their EPA explained that one of the more on the proposed rule. Nor were any of analysis; for example, although this may significant uncertainties in EPA’s the issues inherent in this objection have only represented 5% of the analysis was that EPA failed to account raised as comments on the proposal. samples, it is not clear whether this 5% for the potential effect of treatment in Since the proposed rule was clear that relates to only 5% of the areas where removing carbofuran from finished the issue was relevant, and the NAWQA carbofuran may be used, or whether it drinking water before it is delivered to data were available, Petitioners could actually represents a far greater the consumer supply system. EPA have conducted these analyses and percentage of the use area. Because this explained that an evaluation of raised the issue as part of their information, even if established, would laboratory and field monitoring data comments. Consequently EPA has provide an insufficient basis on which indicate that carbofuran may be determined that the evidence submitted EPA could reasonably conclude that the effectively removed (60–100%) from in support of this objection is not drinking water exposures would be drinking water by lime softening and appropriately considered as a basis for ‘‘safe,’’ this issue is not determinative. activated carbon; other treatment justifying a hearing on its final rule. iii. Denial of objection. For the processes are less effective in removing And in the absence of this evidence, the reasons presented above, the Petitioners’ carbofuran (Ref. 81). Although the objection consists of mere allegations objection is denied. Further, there are Agency was aware of the mitigating and general denials, which do not several significant defects with the effects of specific treatment processes, warrant a hearing (40 CFR 178.32(b)(2)). analysis in Exhibit 16. First, the analysis the processes employed at public water Further, to the extent the objection and was based on statewide averages, which supply utilities across the country vary the evidence in Exhibit 16 rely on use ignores the fact that pH is not evenly significantly both from location to tracking system and risk mitigation distributed, but randomly clustered. location and throughout the year, and proposals submitted as part of their Second NAWQA contained no data for therefore EPA was unable to objections, this hearing request is Kansas (KS), Oklahoma (OK), and South quantitatively incorporate this factor denied as irrelevant, and therefore Dakota (SD); Petitioners simply assert into its drinking water exposure
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estimates. For example, lime softening in individual states will remain is denied. A further consideration is that would likely reduce carbofuran unprotected. In Colorado, only 24% of treatment does not necessarily remove concentrations. That process is used in the population obtains their drinking all residues. As previously noted, in 3 to 21% of drinking water treatment water from groundwater, and in Illinois, both the proposed and final rules EPA systems in the United States (Ref. 14). only 33% of the population obtains discussed the SDWA monitoring Activated carbon has been shown to their drinking water from groundwater. detections between 4 and 7 ppb, which also reduce carbofuran concentrations, Sixteen percent of Colorado’s represent concentrations in samples but is used in 1 to 15% of drinking population is not de minimis. collected post-treatment. As such, these water treatment facilities (Id.). Consequently, even if the analysis were levels are of particular concern to the Petitioners noted this discussion in their accurate, it would not provide a Agency. An infant who consumes a comments, and relied on it to support sufficient basis on which to conclude single 8-ounce serving of water with a their argument that their drinking water that exposures from drinking water concentration of 4 ppb, as detected in exposure assessments were would be ‘‘safe.’’ the monitoring, would receive conservative, because they did not A further consideration in this regard approximately 130% of the aPAD from account for the effect of treatment (Ref. is that drinking water exposures are water consumption alone. An infant 18 at 46–55). However they submitted driven by uniquely local factors; not who consumes a single 8-ounce serving no comments raising any of the issues only is the source of drinking water of water with the higher detected or evidence presented in this objection. local (i.e., a person drinks water from concentration of 7 ppb, as detected in ii. Denial of hearing request. EPA his or her local water system not from the monitoring, would receive denies this hearing request on the a combination of water systems from approximately 220% of the aPAD from grounds that both the objection and the across the United States), but the water consumption alone. proffered evidence are untimely. EPA likelihood and degree of contamination clearly described the potential impact of any particular, local drinking water G. Objections to EPA’s Dietary Risk that treatment could have on its source, whether it is a reservoir or well, Assessment estimates. None of the analyses in varies widely based on local conditions Petitioners raise two related Exhibit 17 were provided as comments (e.g., from local pest pressures, objections to the way in which EPA on the proposed rule. Nor were any of weather). Examining a population evaluated the aggregate dietary the issues inherent in this objection across an entire state—let alone across exposures to carbofuran residues. First raised as comments on the proposal. several states—is an entirely they raise several technical challenges Since the proposed rule clearly inappropriate basis on which to to the way in which EPA calculated the identified the issue, and the USGS data conclude that drinking water exposures two recovery half-lives that were used were available, the Petitioners could will be safe. in the risk assessment supporting the have conducted these analyses, or at The evidence submitted therefore final rule to account for the potential for least raised the issue, as part of their does not support their contention that individuals to recover from the effect of comments. Consequently, as discussed 60% of the population in ‘‘affected ingesting carbofuran residues between in Unit VI.D, EPA has determined that states’’ obtain their drinking water from exposures. Second, they object to the the evidence submitted in support of public systems that use the treatment fact that in the final rule EPA included this objection is not appropriately processes effective at mitigating both aggregate exposure estimates that considered as a basis for justifying a carbofuran residues. For example, did not account for the potential for hearing on its final rule. In the absence Exhibit 17 shows that a major Chicago individuals to recover from the effects of this evidence, the objection consists surface water drinking water system, between exposures as well as estimates of mere allegations and general denials, which serves a population of 9,000,000, that did account for such recovery. In which do not warrant a hearing (40 CFR has neither lime softening processes nor support the Petitioners cite to Exhibits 178.32(b)(2)). Further, to the extent the filters. Petitioners have submitted no 9 and 10. Exhibit 9 is a memorandum objection and the evidence in Exhibit 17 evidence that this population is prepared by Robert Sielken and Ciriaco rely on the new registration proposals protected. The fact that a small Valdez-Flores. Exhibit 10 is a published submitted in June 2009 as part of their population remains unprotected is not literature study by Elsa Reiner that objections, this evidence as well is outweighed by the fact that a larger presents data on the rates of deemed both immaterial and untimely. population in another community or spontaneous reactivation of As discussed in Units VI.C and D, the state is protected. Their own evidence phosphorylated and carbamylated new risk mitigation measures are not also shows that only 26 of 141 of cholinesterases. appropriately considered at this stage of community water systems use lime 1. Objection/hearing request subissue: the administrative process, and no softening/filters (Exhibit 17 at 4–9), Inclusion of exposure estimates that do hearing is warranted on this basis. which supports the conclusion in the not incorporate recovery in final rule. EPA is also denying this hearing final rule that approximately 20% The Petitioners object to the fact that the request on the grounds the Petitioners’ facilities have appropriate treatment. final rule presented aggregated exposure evidentiary proffer is insufficient to See 57 FR 33244 (7/27/92) (Studies estimates that did not incorporate the justify the factual issue urged (40 CFR cited by NRDC do not provide a basis anticipated recovery from carbofuran’s 178.32(b)(2)). The analysis in Exhibit 17 for the hearing because they ‘‘support effects between exposures, in addition is based on the percentage of the total the [FDA] conclusion in question.’’); 57 to those that did account for recovery. population across all states combined, FR 6667 (2/27/1992) (‘‘A hearing must They claim that recovery time should be not the percentage of the local be based on reliable evidence, not on included in EPA’s ‘‘primary’’ risk populations served by an individual mere allegations or on information that assessment. surface water source—or even the is inaccurate and contradicted by the i. Background. As discussed in Unit percentage within each state. Even record.’’); 49 FR 6672 (2/22/84) (no V, EPA’s standard acute dietary assuming that the 60% figure could hearing if claim based on demonstrably exposure assessment calculates total legitimately be translated to a state-by- false premise). dietary exposure over a 24-hour period; state basis, their own analysis shows iii. Denial of objection. For the that is consumption over 24 hours is that some percentage of the population reasons discussed above, this objection summed and no account is taken of the
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fact that eating and drinking occasions addition, they submitted an aggregate is not material. As documented in the may spread out exposures over a day. dietary risk assessment they had final rule, EPA would still have This total daily exposure generally conducted using a 150-minute half-life concluded that revocation of all provides reasonable estimates of the input. They submitted no explanation tolerances were warranted on the risks from acute dietary exposures, for using only the 150-minute half-life grounds that, even accounting for given the nature of most chemical rather than also including estimates recovery, aggregate exposures are not endpoints. Due to the rapid recovery based on the 300-minute half-life that ‘‘safe.’’ Even though accounting for associated with some chemical toxicity EPA has used for the proposed rule. recovery resulted in a 2–3X reduction in (e.g., AChE inhibition), 24-hour In the final rule EPA explained that it exposure estimates, many of EPA’s exposure periods may or may not be had conducted a revised Eating estimates for aggregate exposures ranged appropriate. To the extent that a day’s Occasion analysis to evaluate the impact between 2700% aPAD and 9400% aPAD eating or drinking occasions leading to of carbofuran’s rapid reversibility on its for infants. Accounting for recovery high total daily exposure might be risk estimates (74 FR 23086 (May 15, does not, therefore, demonstrate that found close together in time, or to occur 2009)). EPA concluded that aggregate exposures will be safe for from a single eating event, minimal incorporating Eating Occasion Analysis infants. Of greater significance in this AChE recovery would occur between and the 186-minute or 426-minute regard is EPA’s finding that infants are eating occasions (i.e., exposure events). recovery half-lives for carbofuran did at risk from a single exposure. Recovery In that case, the ‘‘24-hour sum’’ not significantly change the risk is only relevant, by definition, where approach, which sums eating events estimates for food exposures alone (74 the risk is derived from multiple over a 24-hour period, would provide FR 23086 (May 15, 2009)). EPA exposures over time. reasonable estimates of risk from food concluded that risk estimates based on iii. Denial of objection. The reason for and drinking water. Conversely, to the combined food and drinking water not simply adopting the assessment extent that eating occasions leading to exposures are reduced considerably—by incorporating recovery time was that the high total daily exposures are widely a factor of two or more in some cases, Agency has concerns that other aspects separated in time (within 1 day) such but nonetheless still substantially of its exposure model tends to that substantial AChE recovery occurs exceed EPA’s level of concern for understate exposure. If the assessment between eating occasions, then the infants and children. EPA also using recovery time had suggested that estimated risks under any 24-hour sum explained that the Agency remains carbofuran risks may be acceptable, EPA approach may be overstated. In that concerned about the risks from single would have had to further examine how case, a more sophisticated approach— eating or drinking events. Finally, EPA exposure was assessed. However, one that accounts for intra-day eating noted that the Eating Occasion Analyses because both the assessment based on and drinking patterns and the recovery underestimate exposures to the extent 24-hour exposure and the one of AChE between exposure events—may that they do not take into account carry- incorporating recovery time showed be more appropriate. This approach is over effects from previous days, and carbofuran exposures to be well over the referred to as the ‘‘Eating Occasions because drinking water concentrations safe level, EPA concluded that its Analysis’’ and it takes into account the are randomly picked from the entire 30- exposure assessment was reasonable. As fact that the toxicological effect of a first year distribution (Id at 23087). explained in the final rule, dose may be reduced or tempered prior ii. Denial of hearing request. EPA is incorporating Eating Occasion Analysis to a second (or subsequent) dose. denying this hearing request on two and the 186-minute or 426-minute In the proposed rule, EPA conducted grounds. First, the objection fails to recovery half-lives for carbofuran an Eating Occasion analysis based on present a disputed issue of material fact. resulted in a reduction in the risk two half-lives: 150 minutes and 300 The record is clear that EPA did estimates for which food and drinking minutes (73 FR 44887 (July 31, 2008)). incorporate recovery into its analysis; water are jointly considered (i.e., Food These half-lives were not specific to indeed, one of Petitioners’ objections + Drinking Water) by a factor of two or carbofuran, but were calculations relates to the manner in which EPA more in some cases. But even though derived for the NMC Cumulative Risk incorporated recovery into its risk the risk estimates from aggregate Assessment. EPA concluded that assessment (Obj at 30–33). Rather, their exposure are reduced, they nonetheless incorporating these analyses into the only challenge is that the final rule still substantially exceed EPA’s level of risk assessment had little impact on the should have only presented risk concern for infants and children. Using risk estimates from exposures from food estimates that accounted for recovery. drinking water derived from the surface alone, but that risk estimates from The sole issue is whether it was water from the Idaho potato surface combined exposures from food and reasonable for EPA to have also water scenario, which estimated one of water were reduced by approximately communicated aggregate risks that did the lowest exposure distributions, 2–3X (Id). However, because many of not account for recovery, when (1) aggregate exposures at the 99.9th EPA’s risk concerns stemmed from a EPA’s estimates showed that accounting percentile ranged from 328% of the single exposure (e.g., one meal) and for recovery demonstrated that EPA’s aPAD under the scenario for which because, even when recovery was standard 24-hour estimates were not infants rapidly metabolize carbofuran accounted for, aggregate exposures far substantially overstated; (2) EPA’s (e.g., 186-minute half-life), to a high of exceeded safe levels, EPA concluded approach to accounting for recovery 473% of the aPAD under the scenario that ‘‘risks to carbofuran is indeed not underestimates some risks; and (3) for which infants metabolize carbofuran substantively overestimated using * * * EPA’s risk assessments concluded that more slowly (e.g., scenarios in which a the 24-hour approach’’ (Id). infants received unsafe exposures from 426-minute half life is assumed). Either In their comments, Petitioners a single meal (eating occasion). This is way, the tolerances are unsafe. complained that EPA had failed to a policy issue, and hearings are not Moreover, even accounting for the incorporate recovery into their risk appropriate on such (40 CFR estimated decreased risk from assessment. They further argued that 178.32(b)(1)). accounting for carbofuran’s rapid EPA should calculate the per capita Second, the fact that EPA relied on reversibility, for which recovery 99.9th percentile based on all person 24-hour aggregate exposures in addition between exposures is irrelevant. The minutes rather than all person-days. In to analyses that accounted for recovery Agency remains concerned about the
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risks from single eating or drinking concern, the maximum persisting dose the first feeding of the subsequent day events, as illustrated in the following amounts to about 194% of the aPAD (or is short. A single day model also does example, based on an actual food 30% of 554%). Note that with drinking not account for the effect of seasonal consumption diary from the CSFII water concentration at 4 ppb, an infant variations in drinking water survey. A 4-month old male non- consuming one 8 oz bottle of formula— concentrations, which will make this nursing infant weighing 10 kg is prepared from powder and tap water effect more pronounced during the high reported to have consumed a total of containing carbofuran at 4 ppb will use season (i.e., the time of year when 1,070 milliters (ml) of indirect water obtain exposures of approximately drinking water concentrations are high). over eight different occasions during the 114% of aPAD. Since many infants Based on these analyses, the Agency day. The first eating occasion occurred consume the equivalent of this amount concludes that the current exposure at 6:30 a.m., when this 4 month old on a single eating occasion, accounting assessment methods used in the consumed 8 fluid ounces of formula for reversibility over multiple occasions carbofuran dietary assessment provide prepared from powder. The FCID food is not essential to ascertain that infants realistic and high confidence estimates recipes indicate that this particular food quite likely have obtained drinking of risk to carbofuran exposure through item consists of approximately 87.7% water exposures to carbofuran food and water. water, and therefore, 8 ounces of exceeding the level of concern based on In summary, there are several factors formula contains approximately 214 ml drinking water concentrations found in that may cause EPA’s exposure/risk (or grams) of indirect water; with the public drinking water supplies. model to either understate or overstate powder (various nutrients, dairy, soy, The approach discussed above is used exposure/risk. It is unreasonable to oils, etc.) accounting for the remaining to evaluate the extent to which the present risks only incorporating factors 12.3%. This infant also reportedly Agency’s 24-hour approach to dietary that tend to reduce exposure/risk consumed a full 8-ounce bottle of risk assessment overestimates risk from estimates (e.g., recovery time), as formula at 12 p.m., 4 p.m., and 8 p.m. carbofuran exposure. The results of both Petitioners suggest. EPA’s approach of that day. The food diary also indicates approaches indicate that the risk from evaluating the impact that these factors that the infant consumed about 1 carbofuran is indeed not substantively may have on the risk assessment is an tablespoon of water (14.8 ml) added to overestimated using the current appropriate method of taking all prepare rice cereal at 10 a.m., about 2 exposure models and the 24-hour relevant factors into account. ounces of water (59.3 ml) added to pear approach. Petitioners’ objection to EPA’s policy juice at 11 a.m., another 1⁄2 tsp of water In this regard, it is important to note decision to present acute risks in terms (2.5 ml) to prepare more rice cereal at EPA’s Eating Occasion Analyses of 24-hours of exposure is therefore 8:30 p.m.; and finally, he consumed underestimate exposures to the extent denied because EPA’s policy approach another 4 ounces of formula (107 ml) at that they do not take into account carry- here is reasonable. 9:30 p.m. over effects from previous days, and 2. Objection/hearing request subissue: The infant’s total daily water intake because drinking water concentrations Technical challenges to EPA’s (1,070 ml, or approximately 107 ml/kg/ are randomly picked from the entire 30- calculated half-lives. Petitioners day) is not overly conservative, and year distribution. As discussed contend that EPA’s calculation of represents substantially less than the previously, DEEM–FCID is a single day carbofuran half-lives of 186 minutes and 90th percentile value from CSFII on a dietary exposure model, and the DEEM- 426 minutes were flawed, and that the ml water/kg bodyweight (ml/kg/bw) based Eating Occasion Analysis data instead support the use of a 150- basis. As noted, carbofuran has been accounts for reversibility within each minute half-life. Petitioners identify detected in finished water at simulated person-day. All of the three specific challenges: (1) Because concentrations of 4 ppb. For this 10 kg empirical data regarding time and one of the time course studies showed body weight infant, an 8-ounce bottle of amounts consumed (and corresponding that the time-to-peak effect was one formula prepared from water containing exposures based on the corresponding hour, EPA’s assumption that the time- carbofuran at 4 ppb leads to drinking residues) from the CSFII survey are to-peak effect in each study was 15 water exposures of 0.0856 micrograms used, along with the half-life to assess minutes is incorrect; (2) EPA included of active ingredient/kilogram of an equivalent persisting dose that the control rats in its modeling, which bodyweight (μg ai/kg bw), or 114% of produced the peak inhibition expected distorts the estimated recovery half-life the aPAD from that bottle alone. Based over the course of that day. This is a because it incorporates AChE from on the total daily water intake of 1,070 reasonable assumption for food alone; animals that were not dosed and did not ml/day (no reversibility), total daily since the time between exposure events need to recover; (3) Biochemically, the exposures from water at 4 ppb across 2 days is relatively high recovery half-lives of all NMC chemicals concentration would amount to 0.4158 (compared to the half-life)—most should be the same, which supports the μg ai/kg bw, or 555% of the aPAD; this children (>9 months) tend to sleep use of a 150-minute half-life. In support is the amount that would be used for through the night—and the time of these claims, Petitioners offered a this person-day in the Total Daily between dinner and breakfast the summary of written testimony from Drs. Approach. following morning is long enough it is Sielken and Valdez-Flores (Exhibit 9) Peak inhibition occurs following each reasonable to ‘‘ignore’’ persisting effects and a published study (Exhibit 10). occasion on which the infant consumed from the previous day. A single day i. Background. In the proposed rule, 8 fluid ounces of formula (6 a.m., 12 exposure model will underestimate the EPA relied on half-lives of 150 minutes p.m., 4 p.m. and 8 p.m.); however, the persisting effects from drinking water and 300 minutes (73 FR 44887). These maximum persisting dose occurs exposures (formula) among infants, and values were calculated for the NMC following the 9:30 p.m. eating occasion, newborns in particular (<3 months), cumulative risk assessment and so were based on a 186-minute half-life since newborns tend to wake up every intended to encompass the half-lives for parameter. This produces a maximum 2 to 4 hours to feed. Any carry over all of the NMC pesticides. persisting dose of 0.1457 μg ai/kg bw, or effects may be important, especially if In the final rule, EPA calculated half- about 30% of the total daily exposure of exposures from the previous day are lives specific to carbofuran to ensure 0.4158 μg ai/kg bw derived above, or relatively high, since the time between that its analyses accurately reflected expressed as a fraction of the level of the last feeding (formula) of the day and carbofuran’s risk. Using the two FMC
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time course studies in rat pups EPA in this case, the Petitioners never be argued to support the Petitioners’ calculated half-lives for recovery of 186 commented on the 300-minute estimate half-life of 150-minutes. and 426 minutes (Id). The two values EPA used in the proposal, nor raised iii. Denial of objection subissue. All of were derived from two different studies any issue to challenge the reliance on a Petitioners’ claims are incorrect. using rat pups of the same age (Refs. 24, longer half-life to account for the Appropriate time to peak effect. The 25); the two values provide an variation in children’s sensitivity. For Petitioners claim that the time to peak indication that half-lives to recovery can the reasons discussed in Unit VI.D, they effect in the study with MRID 47143704 vary among juvenile rats. By extension, have therefore waived any objection to (Ref. 2) should have been 1 hour instead children are expected to vary in their use of a 300-minute half-life. of the 15 minutes EPA calculated. ability to recover from AChE inhibition Accordingly, the question of whether Petitioners chose this value simply by where longer recoveries would be the Petitioners’ half-life of 150-minutes choosing the data point with the highest associated with a potentially higher or EPA’s estimated half-life of 186- level of inhibition. But this approach is ‘‘persisting dose.’’ minutes is immaterial, since the lower flawed in a number of regards: First as ii. Denial of hearing request. The issue amount of recovery associated with the a practical matter, using the same of the appropriate half-lives for longer 300-minute half-life would be criteria on which the Petitioners rely, carbofuran is not material. Petitioners expected to have a far greater impact the time to peak effect in MRID have proffered no evidence to show that than the use of a 186-minute half-life. 46688913 (Ref. 3) is 15 minutes. reliance on a 150-minute half-life rather EPA is also denying the hearing Petitioners have presented no basis for than a 186-minute half-life would make request because the evidentiary proffer excluding those results. a significant difference to their in support of this objection is More significantly, the Petitioners’ estimates. By contrast, in the risk inadequate. Petitioners have not approach fails to account for the assessment supporting the final rule, provided the underlying analyses variability of the estimated AChE EPA’s estimates show that the use of a conducted in support of their calculated activity at each time point. As a point 150-minute or 186-minute half-life half-lives. The remainder of Exhibit 9 of background, the level of the highest makes little or no difference. For consists of contentions that EPA’s inhibition is not something that can be example, EPA’s estimated exposures analyses were mistaken. In the absence observed, in the way that motor activity from food alone for children 1–2 were of the analyses that support their claim is observed. To determine inhibition, 43% of the aPAD, assuming a 186- that the data support a half-life of 150 samples are taken and measured—the minute half-life, and 41% of the aPAD, minutes, Petitioners’ evidentiary proffer assuming a 150-minute half-life. samples may or may not capture the consists of no more than mere Similarly, for infants, the estimates highest point of inhibition; the allegations and denials. Hearings will ranged from 31% aPAD, assuming a technician has not external indicia that not be granted on this basis (40 CFR 186-minute half-life, and 30% of the will determine the moment of the 178.32(b)(2)) (See 73 FR 42706 (July 23, aPAD, assuming a 150-minute half-life. ‘‘peak.’’ Determining peak inhibition is 2008) (‘‘NRDC does no more than state For all other age groups, the estimated estimated based on the available ‘[w]e are aware of no statistical test’ exposures were identical, whether one measurements. But because which would support EPA’s use of the assumed a 150-minute or 186-minute measurements are generally variable— Gledhill data. As EPA’s regulations half-life. the animals differ and the sampling In any event, Petitioners’ objection make clear, a mere ‘denial’ of an EPA itself is not identical, as people cannot would have ultimately no effect on the position is not sufficient to satisfy the perfectly replicate their actions time Agency’s conclusion that the carbofuran standard for granting a hearing’’) after time—in order to accurately tolerances are not ‘‘safe.’’ Given EPA’s (citations omitted); 53 FR 53176, 53199 capture the peak levels, the variability assessments showing that a single (December 30, 1998) (‘‘Rather than needs to be accounted for. When, as exposure can result in excessive risks to presenting evidence [the objector] here, the individual values are quite infants—a conclusion that Petitioners asserts that FDA did not adequately variable, then for a half-life as long as have not challenged—the extent of justify its conclusions. Such an carbofuran’s, the sampling variability recovery between subsequent exposures assertion will not justify a hearing.’’). will make the study means bounce up is irrelevant. This conclusion alone The published paper in Exhibit 10 and down around a trend line provides an adequate basis to revoke the does not cure this defect. The paper was representing the true recovery rate. carbofuran tolerances. Accordingly, submitted to support the claim that the Figure 2 illustrates the sampling because the action would be the same Petitioners’ 150-minute half-life is variability of the measured AChE even if the factual issue were resolved consistent with the ‘‘available literature activity and its relationship to EPA’s in the manner sought, this request does on the AChE recovery’’ (Obj at 32). This modeling estimates for PND11 pups. In not meet the standard for granting a evidence is immaterial. The Reiner brief, this plots observed versus hearing (40 CFR 178.32(b)(3)). paper relates to the reactivation of the predicted for all the data. Each little There is yet a further consideration AChE enzyme; however the relevant point is an individual animal, while the affecting the materiality of this issue is not the reactivation of the time-group mean is the larger version of objection. EPA’s recalculation of half- cholinesterase enzyme, but the level of the same plotting symbol. The vertical lives in the final rule would ordinarily chemical in that target tissue, which this lines are the 95 percent confidence mean that Petitioners could study does not address. Moreover, this intervals for each mean, the vertical appropriately challenge EPA’s study concludes that ‘‘[I]t follows from lines. The diagonal line in each figure methodology for deriving the revised the data in Tables 1 and 2 that the rate is the identity line—i.e., the line all the half-lives for the first time in their of spontaneous reactivation cannot be data would fall on if there were no objections. This is because the predicted, but must be separately variability and the model were perfect. Petitioners would have had no prior determined for each compound and Normally, one would expect some opportunity to challenge the manner in each enzyme source (Exhibit 10 at 1). random scatter about the identity line. which these estimates were developed, The paper did not include data In such a case, simply visually picking as EPA had not previously relied on specifically on carbofuran, and it is the time with the lowest mean, which carbofuran-specific estimates. However therefore difficult to see how this could is what the Petitioners have done, will
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not be a very reliable way to estimate the time to peak effect.
Inclusion of data from control by carbamate compounds is dictated by anticipated effects in humans. They animals. It is standard scientific practice the commonly-shared NMC carbamyl argue, for several reasons, that EPA to include concurrent control animals group is theoretically plausible, in should have instead used a 3X (i.e., animals that are not dosed with the reality, it is not supported by the data interspecies factor. All of their test substance) as part of any on the NMC compounds. EPA had arguments, however, depend on EPA experimental design. The purpose of originally hoped, based on the same consideration of an oral carbofuran controls is to determine the effects of mechanistic argument Petitioners make, dosing study conducted in humans. the inevitable, unexpected, and that half-lives would be the same across EPA did not rely on the cited human uncontrolled variations in experimental all NMCs, thus greatly simplifying the study because it found, taking into practice, such as the biological variation cumulative risk assessment. It turned account the advice of the HSRB, that the between individual living animals. out, though, in the NMC data sets study was scientifically invalid. EPA’s EPA’s model simply used control levels analyzed for the NMC cumulative risk Human Research rule prohibits EPA to establish a baseline against which to assessment, that estimated recovery from considering scientifically invalid evaluate the recovery of the treated half-lives changed (generally, they got human studies (40 CFR 26.1701). In animals. For example, as discussed longer) as dose increased, which is their objections, Petitioners argue that above, measurements of AChE activities counter to the results that would be the HSRB’s, and presumably EPA’s, may change, and that concurrent predicted from the Petitioners’ simple evaluation of the scientific validity of controls are set up so that the same non- mechanistic argument (Ref. 81). the human study was flawed because (1) dose-related factors that affect treated Ultimately, this is due to the fact that the human study was not considered in animals will also affect control animals. the relevant question is not the abstract light of the animal data on carbofuran; Thus, EPA measured activity and reactivation of the cholinesterase (2) insufficient weight was given prior computed inhibition based on measures enzyme, but the level of chemical in the independent reports on the value of the of activity in treated animals and living animal’s target tissue, which is a Arnold study which reached the concurrent control animals. Thus, if the function both of the pharmacokinetics opposite conclusion from the HSRB; (3) control animals showed that measured of the NMC (i.e., the rate at which the the ‘‘technical’’ concerns raised by the levels of AChE typically varied by 5 chemical is absorbed, distributed among HSRB are addressed by ‘‘the data within percent, if the dosed animal showed tissues, and eliminated) in the animal the study’’ and that these ‘‘technical’’ and the rate of hydrolysis of the leaving inhibition levels of 20 percent, EPA deficiencies do not render the Arnold group off the AChE molecule. These would consider that only 15 percent of study unreliable. parameters vary at least somewhat for the inhibition would be related to the the different carbamates, accounting for 1. Background. There are three chemical exposure. EPA did not the differences in half-lives between the intentional dosing human studies estimate a half-life of recovery for the NMC pesticides. conducted with carbofuran that were control animals and incorporate that conducted by J.D. Arnold in 1976, 1977, into the estimated half-lives, which H. Objection to EPA’s Decision Not To and 1978. One study was an oral seems to be the Petitioners’ allegation. Rely on Carbofuran Human Study ingestion toxicity study and two studies Biochemically, the recovery half-lives Petitioners object to EPA’s reliance on were intended to evaluate toxicity from of all NMC chemicals should be the a default 10X interspecies factor, which dermal exposure (Refs. 7, 8, 9). The oral same. Although the Petitioners’ claim accounts for the uncertainties inherent study conducted with carbofuran was that the recovery rate of AChE inhibited in extrapolating from animal data to the carried out in nine healthy male
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volunteers using an ascending dose obtained for RBC and plasma dermal application of the compound in the schedule and single doses of 0.05, 0.1 cholinesterase levels were highly dermal studies and the inclusion of at least and 0.25 mg/kg (Ref. 7). The two dermal variable. Factors that contributed to this one subject who presented with abnormal toxicity studies were found to have variability included the small sample vestibular function in a pre-dose assessment limited the general utility of the data. significant ethical deficiencies and the size, the inclusion of only a single Collectively, the weaknesses in the conduct EPA’s Human Studies Review Board baseline sample collected immediately and outcomes of the carbofuran human recommended against their use. The prior to dosing used to compare all post- studies cast doubt on the utility of the data Petitioners do not challenge the dosing samples, the small number of for identifying a NOAEL or LOAEL or for decision to disregard these studies. control subjects, and an uncommon comparing across species in consideration of As previously noted, EPA did not rely method for analytical determination of the interspecies uncertainty factor for the upon any of the existing intentional cholinesterase activities. The cumulative risk assessment. Thus the dosing human toxicity study deriving an contribution of potential laboratory majority of HSRB members agreed the human oral data should not be used to identify a acceptable level of exposure for error cannot be ruled out. (4) Plasma carbofuran. Instead, EPA relied on data NOAEL or LOAEL, and there was unanimous cholinesterase levels were highly agreement that the human dermal data conducted with rats, and applied the variable in all studies so as to preclude should also not be used for these evaluations. default 10 × interspecies factor to any useful interpretation. In general, The HSRB concluded that while these account for the potential uncertainty in plasma cholinesterase levels were not studies were informative, due to the extrapolating from animal data. EPA’s consistent with changes in RBC numerous technical issues regarding the decision not to rely on the Arnold cholinesterase activities. (5) One subject conduct of the oral study, overall, the studies was made pursuant to its who presented with abnormal vestibular weaknesses of the studies far outweigh Human Research rule. As explained in mechanisms in the pre-dose evaluation the strengths. Describing the studies as Unit III.B, that rule establishes different was used in the oral study and showed ‘‘poor science,’’ the HSRB ethical standards for the review of serious symptoms after treatment. (6) recommended against the use of the oral completed human studies depending on Subjects were allowed to smoke during study conducted with carbofuran in whether they were initiated before or the study period. after the effective date of the rule on In response to a specific request from human subjects for the single chemical April 7, 2006. For an intentional human the Agency, the Board provided assessment or in informing the exposure study such as the Arnold additional analysis concerning the interspecies uncertainty factor for the studies, that was initiated prior to April potential for the data in human subjects cumulative assessment. In their comments opposing EPA’s 7, 2006, EPA is barred, subject to a very for carbofuran to be applied to: (1) The proposal to revoke carbofuran limited exception, from relying on it if calculation of a benchmark dose tolerances, Petitioners essentially raised there is clear and convincing evidence (BMD ) and identification of the 10 the same arguments they present in that the conduct of the research was BMD L (lower confidence limit); (2) the 10 their objections. fundamentally unethical or significantly identification of a NOAEL or LOAEL for deficient with respect to the ethical In responding to Petitioners’ effects or (3) the comparison to other comments, EPA explained that it agreed standards prevailing at the time the species for possible adjustments to research was conducted (40 CFR with the HSRB’s conclusions that the uncertainty factor for the cumulative studies were scientifically flawed, and 26.1704, 26.1706). Further, the rule assessment. The HSRB provided the limits the human research that can be that, therefore, under the Human following additional perspective relative Research rule, EPA was barred from relied upon by EPA to ‘‘scientifically to the Agency’s question: valid and relevant data’’ (40 CFR considering them (Ref. 85 at 9). 26.1701). Finally, because the Arnold The utility of the human studies with 2. Denial of hearing request. The study was conducted with the purpose carbofuran was limited by the very small critical issue here is EPA’s sample size used in all of the studies. The of identifying or measuring a toxic determination under the Human Agency proposed to use the RBC Research rule that the Arnold study was effect, EPA is required by the rule to cholinesterase data for determination of the scientifically invalid. All of Petitioners’ submit its determination regarding these BMDL10. However, under conditions where issues to an independent expert the group size was only two, it would be arguments concerning the choice of the advisory body known as the Human imperative to have highly accurate, valid, interspecies safety factor rely on EPA’s Studies Review Board (‘‘HSRB’’) for reliable and consistent measures of RBC consideration of the Arnold study. As review. These procedures were followed cholinesterase activity in both control and noted above, Petitioners make three with regard to the Arnold study. carbofuran-treated subjects. This rigor was arguments as to why EPA erred in its The HSRB reviewed the Arnold oral simply not achieved in the human studies. determination. For the reasons and dermal carbofuran human studies at Rather, RBC cholinesterase activities were discussed below, none of those its May, 2006 meeting (Refs. 7, 8, 9). The compared to a single baseline value, were arguments satisfy the regulatory highly variable across subjects, including Board found numerous technical controls, and did not show any consistency standard for granting a hearing. Further, deficiencies regarding the conduct of with plasma cholinesterase levels. As such, as explained in Unit VI.H.3., Petitioners’ the oral study and that overall, the although EPA scientists calculated a BMDL10 objections to EPA’s determination have weaknesses of the studies far outweigh from the time course of changes in RBC no merit. Thus, there is no need to the strengths. These deficiencies cholinesterase values in the nine subjects consider Petitioners’ more general included: (1) There was no justification evaluated in the oral study, the HSRB arguments about EPA’s decision to use or rationale for the selection of doses concluded that the accuracy and reliability of a 10X interspecies factor in assessing used in any of the three studies. (2) The this calculation was limited by the technical carbofuran’s risk. sample size was very small (typically shortcomings noted for the study. Therefore, Petitioners’ first argument as to why two subjects per dose or condition) with the HSRB reiterated its recommendation that EPA erred in its determination that the the BMDL10 calculated by the Agency from few or no controls (no more than two the human data should not be used. Arnold study was scientifically invalid control subjects in any study). Such a In a similar manner, the small sample size, is that EPA failed to consider the animal design prevented evaluation of compounded by the lack of consistent data on carbofuran in assessing the statistical significance for any parameter changes in cholinesterase activities in all scientific quality of the Arnold study. measured in the studies. (3) The values studies, the inappropriate methods used for This claim is not material and thus not
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appropriate for a hearing (40 CFR explanation for accepting the HSRB’s First, the HSRB was fully apprised of 178.32(b)(3)). Under the Human reasoning as to the weaknesses of the the earlier peer review reports. EPA Research Rule, the relevant question is studies that rendered them scientifically relied on the reports because EPA’s whether the Arnold study is invalid. Specifically, Petitioners do not position before the HSRB was that the scientifically valid, not whether address the HSRB’s conclusion, adopted Arnold study should be found to meet consideration of the Arnold study in by EPA, that ‘‘the weaknesses in the the standard of the Human Research conjunction with the animal data could conduct and outcomes of the carbofuran rule and would be useful in establishing justify a lower interspecies factor. EPA, human studies cast doubt on the utility points of departure for the carbofuran’s and the HSRB, found the Arnold study of the data for * * * comparing across single chemical assessment and in to be flawed at its core—due primarily species in consideration of the informing the interspecies uncertainty to its small sample size and the high interspecies uncertainty factor.’’ Nor do factor for the NMC CRA. It was clearly variability in measurement of AChE Petitioners offer any reason as to why in EPA’s interest that the HSRB be made inhibition—and no amount of data from the HSRB’s conclusion is not aware of the earlier reports. In fact, the other studies in animals can cure these ‘‘justifiable’’ in light of the individual background materials provided to the defects in the Arnold study. Thus, peer review reports from Drs. Brimijoin, Board included the peer review reports Petitioners’ claim here is irrelevant and Chambers, and Pope. Actually, there are by Drs. Brimijoin, Chambers, and Pope, immaterial to EPA’s decision. several very good reasons for EPA to and the Agency’s Weight-of-the- Ultimately, Petitioners’ objection is a place primary weight on the HSRB’s Evidence presentation to the HSRB challenge to the policy established in report compared to the three individual which noted the contributions of these the Human Research rule that EPA will reports from Drs. Brimijoin, Chambers, reviewers. Further, both the peer review not routinely consider all human data. and Pope prepared in 1997. First, the reports and EPA’s Weight-of-Evidence They contend that ‘‘[s]ince [human] data prior reports were not produced under presentations were included in the exist for carbofuran, they should have the rubric of the Human Research rule, public docket for the HSRB review. To been used to select the interspecies which has a different scope of inquiry the extent that the HSRB was still uncertainty factor.’’ However, this than a traditional peer review. Second, somehow unaware of the prior reports, policy question is not open for debate Drs. Brimijoin, Chambers, and Pope FMC clearly referenced them in both its under the terms of the Human Research made their recommendation regarding written and oral comments to the Board. rule. And more importantly, such a use of the Arnold study for a RfD in the Second, EPA’s determination on the question does not provide a basis for a context of a very different overall recusal of Drs. Brimijoin and Chambers hearing (40 CFR 178.32(b)(1)). database for carbofuran. A significant was clearly consistent with Agency Second, Petitioners argue that number of new toxicity studies have policy and well with EPA’s discretion. insufficient weight was given the prior been submitted since 1997. Third, Drs. The EPA’s Peer Review Handbook (3rd independent reports on the Arnold Brimijoin, Chambers, and Pope all noted Edition) (Ref. 80) provides guidance study. However, the weight EPA should the severe deficiencies in the Arnold about peer review processes of the give under the Human Research rule to study but proposed that they be dealt Agency. Of particular relevance is the pre-rule independent reviews as with through the use of additional safety Handbook’s guidance regarding opposed to the conclusions of the factors. Given these considerations it independent peer reviewers. While the HSRB—the body established by the rule was reasonable for EPA to place primary Handbook notes that there is no for the purpose of aiding EPA’s reliance on the HSRB’s report. prohibition against using the same peer implementation of it—is a legal/policy The bulk of Petitioners’ argument reviewer more than once on the same question and not a factual one. Hearings concerning EPA’s determination on the product, it nevertheless advises that ‘‘it will not be granted on legal/policy scientific validity of the Arnold study is is preferable to use different people each issues (40 CFR 178.32(b)(1)). devoted to suggesting that the HSRB’s time to provide a broader perspective Finally, Petitioners’ claims that EPA review of the Arnold study was (Ref. 80 at 13). Further the Handbook and the HSRB identified merely somehow ‘‘inadequate’’ because two advises that the review of experts who ‘‘technical’’ deficiencies in the Arnold members of the HSRB (Drs. Brimijoin ‘‘have participated substantially in the study and that these deficiencies are and Chambers) were recused from the development of a product * * * may ‘‘address[ed]’’ by ‘‘data within the study review due to their prior participation not qualify as unbiased, independent itself’’ and, therefore, do not render the in a prior independent peer review. peer review * * *’’ (Id.). Therefore, study ‘‘unreliable’’ are no more than Petitioners also assert that the HSRB EPA concluded that, under the mere allegations and thus provide an was hampered because EPA ‘‘never circumstances, a question could be insufficient basis for the granting of a informed the HSRB that it could call raised regarding the impartiality of Drs. hearing (40 CFR 178.32(b)(2)). upon these experts for questioning or Brimijoin and Chambers from the Petitioners have proffered no evidence information regarding their prior peer particular matter under review by the regarding the ‘‘technical’’ nature of the review of the human studies, nor was it HSRB. Further support on this point can deficiencies in the Arnold study or how informed of—or provided with—those be found in the regulations at 5 CFR the deficiencies in sample size or prior reviews.’’ 2635.502(a)(2), and in the preamble to variability are addressed within the These claims are wholly without the original regulation (56 FR 33778 study. Moreover, the record is clear that merit. As laid out in a letter responding (July 23, 1991)). the deficiencies in the study are to FMC’s complaint regarding the In light of these considerations, EPA fundamental in nature and a hearing recusal of Drs. Brimijoin and Chambers addressed the appearance issue will not be granted on bald objections from the HSRB review of the carbofuran regarding Drs. Brimijoin and Chambers that are contradicted by the record (73 human studies, the recusal was entirely by determining whether authorization FR 42696 (July 23, 2008) (hearing appropriate, and consistent with EPA’s by the Agency designee should be denied when objection was contradicted policies and regulations. The facts invoked (see, 5 CFR 2635.502(d)). Three by record and no evidence proffered in outlined in that letter also demonstrate factors were particularly relevant to the support)). that the HSRB’s review was in no way determination of Drs. Brimijoin and 3. Denial of objection. Petitioners restricted or hampered by the limited Chambers (see, 5 CFR 2635.502(d)(4), have offered no response to EPA’s recusal of the two Board members. (5), and (6)): the sensitivity of the
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matter, the difficulty of reassigning the identified the import tolerances as a exposures to carbofuran residues from matter to another employee, and subset that might meet the safety all remaining uses, when combined adjustments that may be made in the standard (Id.). with residues found in drinking water, employee’s duties that would reduce or No one submitted any comments were unsafe (74 FR 23084–23088 (May eliminate the likelihood that a alleging the need to retain individual 15, 2009). reasonable person would question the tolerances for purposes of imports, or EPA can only maintain tolerances that employee’s impartiality. After indicated an intention to seek to it can determine will be ‘‘safe’’ within considering these factors, the Agency maintain those tolerances. The only the meaning of section 408(b)(2)(A)(ii). decided the prudent course was be to subset of tolerances that commenters In making this determination, EPA must recuse Drs. Brimijoin and Chambers suggested was safe was the subset consider aggregate exposures from from the HSRB carbofuran discussion identified by the Petitioners, which ‘‘dietary exposure under the tolerance but to authorize limited, as needed, included the import tolerances along and all other tolerances in effect for the participation. with four domestic food uses. pesticide chemical residue, and As documented in Dr. William In the final rule, EPA analyzed the exposure from other non-occupational Farland’s May 1, 2006 memorandum aggregate exposures from the subset of sources’’ (21 U.S.C. 346a(b)(2)(D)(vi)). entitled, ‘‘Ethics Determination for tolerances the Petitioners sought to At the time of the final rule, EPA Participation at the May 2–3, 2006 EPA retain, and concluded that the aggregate evaluated the safety to the public from Human Studies Review Board Meeting’’ residues from food covered by those all dietary exposures to residues of (Ref. 39), EPA authorized the HSRB to tolerances and from residues in drinking carbofuran, which included not only the ask Drs. Brimijoin and Chambers water are unsafe (74 FR 23084–23088). import tolerances, but also from clarifying questions regarding their 1997 2. Denial of hearing request. A residues on foods associated with review, in the event that the HSRB hearing is denied on this subissue domestic registrations and from residues deemed it necessary as part of their because there is no disputed factual in drinking water contaminated by the deliberations. At no point during the matter for resolution at a hearing. As the domestic uses. Indeed, until domestic meeting did any of the HSRB’s members objection notes, EPA and Petitioners’ use ceases—or at least until EPA has a indicate in any way that they wanted to risk assessment both concluded that the reasonable basis to believe that it will consult with their recused colleagues. residues from imported food alone fell cease—the Agency has no discretion to Nor did any of the members state that within the risk cup (Obj. at 52–54). The ignore the exposures from those uses. they wanted clarification on any point only issue this objection raises is And revocation of the tolerances associated with the study. whether EPA should have themselves does not necessarily resolve For all of the above reasons, independently determined to retain a the issue, given the circumstances here. Petitioners’ objection on this point is subset of the tolerances that Petitioners Until the registrations are cancelled, denied. sought to maintain. This is a legal issue, residues from contaminated drinking and hearings are not appropriate on water, which is the primary contributor I. Objections to Revocation of Import such issues (40 CFR 178.32(b)(1)). (See Tolerances to the risks, must be included in EPA’s 73 FR 42696–42697 (July 23, 2008) risk assessment (Id). Petitioners object to EPA’s revocation (denying NRDC’s request for a hearing The consequence of this requirement of the tolerances for imported foods on objection that children’s safety factor is that, when one tolerance is unsafe, all along with the tolerances associated could not be reduced in absence of tolerances are equally unsafe until with domestic uses. Petitioners allege endocrine screening data). FDA also has aggregate exposures have been reduced that the revocation of the import repeatedly confirmed that the to acceptable levels. Accordingly, in tolerances is not supported by the application of a legal standard to circumstances where aggregate available data because EPA’s own risk undisputed facts is a question of law for exposures exceed the risk cup, there are assessments conclude that, when which a hearing is not required. (See, potentially multiple variations of the considered separately from the domestic e.g., 68 FR 46403, 46406 n.18, 46408, potential subset of tolerances that might uses, the residues from imported foods 46409 (August 5, 2003) (whether facts in meet the safety standard. FFDCA section covered by these tolerances are ‘‘safe.’’ the record show there is a reasonable 408 does not compel EPA to determine Petitioners further argue that EPA ‘‘has certainty of no harm is a question of the appropriate subset that would meet not asserted any claim or rationale in law; whether a particular effect is a the safety standard. EPA is compelled the Final Order justifying its ‘‘harm’’ is a question of law)). ‘‘to revoke or modify a tolerance if conclusions that the import tolerances In addition, Petitioners failed to raise [EPA] determines it is not safe,’’ but the are unsafe’’ and therefore the revocation this issue as part of their comments on statute grants EPA the discretion to is unjustified. the proposed rule, and never requested determine how to proceed where more 1. Background. In the proposed rule, retention of only the import tolerances. than one tolerance is unsafe. EPA’s EPA explained that its finding that Accordingly, as discussed in Unit VI.D, general policy in such situations is not aggregate exposure from all of the EPA considers this issue to have been to independently select the subset that existing uses of carbofuran is not safe untimely raised, and therefore waived. meets the standard, but to rely on the does not necessarily mean that no (See, 73 FR 42,696 (July 23, 2008) pesticide registrant and the public to individual tolerance or group of (denying NRDC’s hearing request on determine which of the various subsets tolerances could meet the FFDCA claims not presented in their original of tolerances are of sufficient 408(b)(2) safety standard and be petition); 72 FR 39318, 39324 (July 18, importance to warrant retention. There maintained (73 FR 44865 (July 31, 2007) (ruling that parties may not raise are a number of reasons EPA adopted 2008)). Rather, to the extent parties new issues in filing objections to EPA’s this policy; it would be an unreasonable wanted to retain a particular subset of denial of original petition)). burden for the Agency to evaluate every existing tolerances, the onus was on 3. Denial of Objection. Petitioners possible combination of tolerances that commenters to identify those uses and incorrectly allege that EPA provided no might fit within the risk cup. In to submit information to demonstrate rationale for the revocations of the addition, if there were multiple different that the tolerance(s) meet the statutory import tolerances. In the final rule, EPA combinations that might within the risk standard. Indeed, EPA specifically clearly found that the aggregate cup, it is not clear that any party would
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agree that EPA had selected the also places EPA under a special state in the proposed rule that appropriate combination of tolerances. injunction to protect infants and comments and information must be This is particularly relevant, since EPA children from the risks of pesticides (21 submitted in the comment period to be relies on individual entities to maintain U.S.C. 346a(b)(2)(C)). EPA has made a preserved but in 2007 EPA denied a the tolerance, by continuing to submit final determination that carbofuran hearing to a party who treated the necessary data to demonstrate the tolerances are unsafe and further notice-and-comment rulemaking continuing safety of the covered determined that that lack of safety falls process in a similarly cavalier fashion. residues. hardest on infants and children. In that instance, the party in question, Petitioners had the statutory right under like Petitioners, filed objections that J. Summary of Reasons for Denial of FFDCA to challenge the accuracy of largely mirrored its earlier submissions Petitioners’ Objections and Hearing EPA’s safety finding on carbofuran to the Agency without taking into Requests tolerances. FMC also has the statutory account how EPA’s final action had 1. General Denial. All of Petitioners’ right under FIFRA to request altered the nature of issues in dispute objections and hearing requests are amendment of its registration. What (See, e.g., 73 FR 42693 (‘‘NRDC’s denied because they are irrelevant, and Petitioners may not do is prolong the objections largely restate the claims in thus immaterial, to EPA’s final FFDCA tolerance revocation process by its petition. Significantly, NRDC does regulation revoking carbofuran challenging EPA’s safety determination not acknowledge or respond to the tolerances. The lack of relevance stems based on proposed FIFRA registration DDVP dietary and residential risk from Petitioners’ decision to object not changes that were not before EPA at the assessments made in response to the to the safety decision EPA made in its time of its final revocation decision. NRDC petition.’’)). Such objections and final revocation regulation but to 2. Alternate Grounds for Denial. hearing requests were denied for a lack instead argue that EPA should reach a Despite the fact that Petitioners’ of materiality (73 FR 42698–42699 different decision based on FMC’s objections and hearing requests are (‘‘When an objector does not challenge proposed changes to the carbofuran facially defective for reliance on newly- EPA conclusions in the section registration that were submitted to EPA proposed FIFRA registration 408(d)(4)(iii) order but rather challenges 44 days after the regulation published in amendments, EPA has carefully some prior conclusion that was the Federal Register. These proposed examined each of Petitioners’ objections superseded by the section 408(d)(4)(iii) registration changes are central to and and hearing requests and found that, in order, the objector has not raised a live inextricably intertwined with the every instance, there are alternate controversy as to an issue material to contention that underlies all of grounds for denial. Those grounds are the section 408(d)(4)(iii) order.’’). Petitioners’ objections—that the summarized below. a. Children’s Safety Factor Objection. carbofuran tolerances are safe, because There are multiple problems with In support of their objection on the in order to retain the contested Petitioners’ hearing requests. Many of children’s safety factor, Petitioners put tolerances, Petitioners must succeed on these problems stem from the forward several arguments; EPA all of their objections. There exist Petitioners’ decision to withhold summarizes below the various reasons statutory and regulatory procedures analyses and information from the for rejecting Petitioners’ hearing under FIFRA for FMC to pursue an notice-and-comment rulemaking portion requests and objections on each amended carbofuran registration. As of this proceeding. Thus, despite EPA’s argument. Given the voluminous part of seeking an amended registration, clear warning that issues not raised in number of arguments asserted by FMC may petition to reestablish the comments on the proposed rule, and petitioners in support of this objection, revoked carbofuran tolerances. information not submitted in that same it is easy to lose track of the fact that all However, it is not proper to object to a timeframe, would be considered of the arguments relate to a single final FFDCA tolerance revocation waived, Petitioners included several decision by EPA—the decision to regulation based on the assertion that new issues, and numerous documents reduce the presumptive 10X children’s subsequently-filed, and as of yet and analyses for the first time with their safety factor to 4X, rather than to 1X or unapproved FIFRA registration objections although they were clearly 2X as the Petitioners desire. amendments, may change the risk available earlier. Petitioners also have, (i) Subissue: Are brain AChE picture under the FFDCA. for the most part, ignored how EPA measures in juveniles adequately FMC has had ample opportunity prior responded to the comments they did protective of CNS effects in juveniles? to issuance of the final tolerance submit in the notice-and-comment EPA based its determination to reduce revocation regulation to amend its rulemaking, and instead have often the children’s safety factor to 4X on the FIFRA registration, whether during the merely recycled their earlier comments ratio of sensitivity shown between comment period on the proposed rule, as objections without addressing the carbofuran’s effects on RBC AChE and the extended reregistration process, or reasons why EPA found them lacking in brain AChE in juvenile rats. It is EPA’s the public process initiated as part of the first instance. This strategy, general policy to rely on RBC AChE as the NOIC for carbofuran. And FMC has unfortunately for Petitioners, is fatal to a surrogate for effects on the PNS but requested a number of modifications to many of their hearing requests and Petitioners failed to provide adequate its registrations during that time period. objections. EPA will not grant hearings RBC AChE data in juveniles to fully Yet, FMC has waited until EPA issued on issues that have been waived, on characterize the dose level of concern a final revocation regulation finding that issues where supporting documents for PNS effects in infants and children. carbofuran tolerances are unsafe, were untimely submitted, or on claims Petitioners claim EPA was wrong from particularly as to infants and children, that have become stale in that EPA the start. They claim that once EPA before filing its latest series of proposed addressed them in the final rule and determined it had adequate data on FIFRA registration amendments. For Petitioners have not responded by brain AChE, the RBC data was irrelevant this FFDCA proceeding, that is too late. clarifying where disputed issues still because brain AChE is an adequately- The FFDCA commands that EPA ‘‘shall remain. protective surrogate for PNS effects. modify or revoke a tolerance if the It is not as if Petitioners lacked Petitioners’ hearing requests and Administrator determines it is not safe’’ warning that EPA would take such an objections on this issue are denied for (21 U.S.C. 346a(b)(2)(A)(i)). The statute approach. Not only did EPA clearly identical reasons: the available evidence
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identified by petitioners is ‘‘insufficient most circumstances. A hearing is not Petitioners did not raise this issue in its to justify the factual determination warranted on this subissue because comments on the proposed tolerance urged’’ (40 CFR 178.32(b)(2)). The Petitioners’ evidentiary proffers either revocation. A hearing on this issue is critical issue with regard to EPA’s concern matters of undisputed fact (e.g., also inappropriate because the issue is children’s safety factor decision is RBC AChE inhibition is not an adverse immaterial. EPA’s decision that a 4X whether EPA has reliable data to ensure effect, RBC AChE can be variable at low children’s safety factor is appropriate that residues of carbofuran in food will doses) or inadequate and irrelevant data did not rest exclusively—or even not cause adverse effects on infants and on other pesticides. Further, Petitioners’ significantly—on the effects observed in children’s PNS. Petitioners claim that claim basically reduces to an argument this developmental study. Rather, EPA carbofuran data on brain AChE in over which is the ‘‘preferred’’ surrogate retained the children’s safety factor juveniles is such reliable data. However, for PNS effects in the absence of data based on the lack of data in the PNS the evidence they proffer to support directly measuring such effects. Thus, and/or a surrogate at the low end of the such an assertion is facially insufficient. this subissue is an argument about response curve, and the fact that the Primarily, Petitioners cite data involving science policy and EPA’s regulations are available pup RBC data at higher doses comparisons of brain AChE and PNS clear that hearings will not be held on affirmatively indicate that the PNS effects in adult animals. But evidence policy matters. Even more problematic appears to be significantly more from adult animals is beside the point; to Petitioners’ hearing request on this sensitive than the CNS. the question is whether brain AChE in subissue is its lack of materiality. Petitioners’ objection on this subissue juveniles is protective of the PNS in Having failed in the previous subissue is denied because both parties agree that juveniles. For at least 25 years, EPA has to proffer sufficient evidence to show muscle fasiculations, which are the required toxicity tests be performed carbofuran brain AChE data in juveniles movements EPA described at the SAP with pre- and post-natal animals as well is protective of carbofuran’s effect on meeting and in the proposed and final as adult animals because young animals the PNS in juveniles, Petitioners’ rules, are PNS-mediated effects. Further, can be more sensitive and affected in a attempt to attack EPA’s basis for it is unclear that the effects described in different manner than adults. Further, addressing carbofuran’s effects on the the studies Petitioners submitted are the only studies Petitioners cite that PNS in juveniles can only undercut actually the same effects seen in the compared brain AChE in juveniles with Petitioners’ ability to demonstrate the carbofuran study; other factors in the PNS effects in juveniles, were safety of the carbofuran tolerances. With studies suggest that the movements conducted using other pesticides. For the demise of Petitioners’ brain AChE being studied are not purely cholinergic, good reason, EPA requires that argument, EPA’s analysis of the RBC which calls into question whether the pesticides be individually tested in AChE data is the only remaining basis effects are the same. For the same toxicity studies. Moreover, the majority for reducing the children’s safety factor. reason, this calls into question the of the data cited by Petitioners in other If Petitioners are successful in showing contention that the effects are chemicals actually fails to demonstrate that RBC AChE data are not a reliable exclusively CNS-related. Finally, the that the brain is more sensitive than the measure of PNS effects in juveniles, cited studies fail to support Petitioners’ PNS, and the remainder of the evidence EPA would have no reliable data on remaining contentions. Since it is is, at best, merely equivocal on this such impacts and would be required to unclear that the studies actually point. retain the full children’s safety factor. describe the same effects, and To reiterate, if EPA chooses to select As such, Petitioners’ claim is Petitioners have failed to demonstrate a children’s safety factor different than immaterial; even if the claim were that the effects are exclusively CNS- 10X, it bears the statutory burden of upheld, it would not justify the ultimate related, the evidence does not, therefore, showing that reliable data support its relief sought by Petitioners. determination that the selected factor is As to Petitioners’ objection to EPA’s rebut EPA’s conclusions regarding the safe for infants and children. Thus, science policy decision to use RBC movements described in the carbofuran Petitioners, in seeking to establish that cholinesterase as a surrogate for PNS study. EPA erred by not selecting an even effects, EPA explains in detail in Unit (iv) Subissue: Did EPA err by relying lower children’s safety factor for VI.E, the biological basis for its policy on studies not conducted pursuant to carbofuran (in fact, no such factor at all), decision, the multitude of data EPA’s GLP regulations? Petitioners similarly bear the burden of showing supporting its approach, and the claim that EPA’s reliance on the ORD that there are reliable data for the frequent consultations with the SAP data is problematic because the data proposition that juvenile brain AChE concerning the wisdom of using such an were not conducted in accordance with data for carbofuran are protective of approach. The equivocal data submitted EPA’s GLP regulations at 40 CFR part PNS effects in children. Petitioners’ by Petitioners does not raise a serious 160. Petitioners have not cited any equivocal and largely irrelevant proffer question regarding EPA’s policy. In any evidence suggesting there is a cannot meet that standard, particularly event, as noted with regard to the substantive problem with the ORD data where EPA is lacking data it has hearing request, this subissue lacks or made any arguments to such effect. traditionally-required on cholinesterase- materiality in that success on this Thus, this subissue presents only a legal inhibiting pesticides to protect against subissue by Petitioners would retard question and legal questions are not PNS effects, and the data EPA does have rather than advance their challenge to appropriate grounds for a hearing. EPA on measures of PNS effects indicate that EPA’s action. denies Petitioners’ objection on this effects on the juvenile PNS occur at (iii) Subissue: Is ‘‘lip-smacking’’ a point because EPA regulations make lower doses than effects on brain AChE. CNS or PNS effect? Petitioners object clear its GLP regulations only apply to (ii) Subissue: Are RBC AChE measures that EPA’s evidence of ‘‘lip smacking’’ studies in support of a pesticide adequately reliable evidence of CNS in a carbofuran adult developmental rat registration or tolerance (40 CFR effects? As a corollary to their claim that study does not support concern for 160.1(a), 160.3). In any event, non- brain AChE measures are adequately potential PNS effects because lip compliance with the GLP regulations protective of PNS effects, Petitioners smacking is more properly correlated to does not automatically disqualify a also argue that RBC is not an CNS, rather than PNS inhibition. A study from EPA consideration but rather appropriate surrogate for CNS effects in hearing is denied on this issue because goes to reliability (40 CFR 160.17(a)).
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(As noted, Petitioners have made no revocation rule either by explaining inhibition in juveniles due to carbofuran claim that the ORD data is not reliable.). their disagreement with EPA’s critique exposure scientifically valid? Petitioners (v) Subissue: Was EPA’s selection of a or proffering evidence to counter EPA’s allege that EPA’s approach to 4X children’s safety factor consistent conclusion. Rather, Petitioners simply calculating the relative sensitivity with EPA’s approach to other carbamate resubmitted essentially the same between AChE inhibition in brain and pesticides? Petitioners object that EPA comments they provided on the RBC in juveniles is not scientifically was inconsistent in retaining a 4X proposed rule. Petitioners also again valid. EPA derived the ratio of RBC and children’s safety factor for carbofuran failed to submit the underlying analysis brain AChE inhibition using the data on given that EPA removed the children’s supporting their within animal administered dose (measured in terms safety factor for other carbamates. A calculations. of BMD50) for PND11 animals. In hearing is not appropriate on this A hearing on this subissue is not addition, the Petitioners criticize EPA subissue because it presents a purely appropriate for two reasons. First, for incorrectly assuming that the legal question. There is no dispute Petitioners’ repeated failure to submit relationship of the dose response curve regarding the facts of EPA’s decision in the analysis supporting their claim between BMD50s and BMD10s is linear, each case, the only question is whether reduces this objection to a mere which they claim overstates the EPA acted appropriately on carbofuran allegation. Under EPA’s regulations, potential differences. In support of the given its decision on the children’s hearings will not be granted on the basis claim that EPA’s approach overstates safety factor for other carbamate of mere allegations. More importantly, the differences, Petitioners argue that pesticides, such as carbaryl. The Petitioners’ objection on this subissue is data suggests that BMD50s for brain and objection is denied because EPA’s irrelevant, and therefore immaterial, RBC AChE inhibition for the carbamates decisions in each case were consistent; with regard to EPA’s final tolerance tend to diverge more than the dose EPA applied a different children’s safety revocation regulation because levels that cause the low levels of AChE factor to carbofuran than to the other Petitioners ignored EPA’s extensive inhibition used to select the PoD (i.e., carbamate pesticides based on the analysis of this subissue in the final rule the BMD10s), which demonstrates that at different facts in each case. For and refiled their comments on the levels causing lower levels of inhibition, example, the data showed that carbaryl proposal as if EPA’s determination in no safety factor is necessary. Petitioners’ differed significantly from carbofuran in the final rule did not exist. The statute, argument is that the 4X ratio EPA terms of each chemical’s relative however, requires that objections be calculated based on the BMD50 is sensitivity in juveniles with regard to filed on the final rule, not on the unnecessarily protective, because the brain and RBC AChE inhibition. For proposal. By ignoring the EPA’s final difference between brain and RBC at the carbofuran, EPA concluded that RBC rule on this subissue, Petitioners have doses causing lower levels of inhibition AChE inhibition in juveniles was more failed to lodge a relevant objection. Both (i.e., 10%), which are the levels at sensitive than brain AChE inhibition in EPA and FDA precedent make clear that which EPA is regulating, would not be juveniles by a factor of 4X. For carbaryl, when the agency substantively responds significant. the AChE inhibition in brain and RBC to comments on the proposal, the Petitioners’ hearing request on this of juveniles was essentially equal. commenter may only keep that issue subissue is denied for two reasons. First, (vi) Subissue: Did EPA err in not using alive in its objections by addressing the Petitioners proffered no evidence on any within-animal brain to RBC AChE agency’s substantive response. In other carbamate, much less carbofuran, in inhibition comparisons to derive the words, the final rule is the focal point support of their claim that BMD50s for children’s safety factor? EPA derived an for determining whether issues remain the carbamates tend to diverge more alternate to the default 10X children’s that must be resolved by the objection than the BMD10s or that the response safety factor based on the ratio of RBC and hearing process. Any other curve between BMD50s and BMD10s is and brain AChE inhibition. In their approach relegates the notice-and- not linear. A hearing will not be granted comments on the proposed rule, comment rulemaking stage of the on the basis of mere allegations. Second, Petitioners criticized this approach, revocation process to a meaningless Petitioners’ claims are immaterial arguing that EPA should have compared exercise. because unless Petitioners can show the RBC and brain AChE inhibition Petitioners’ objections on this what the relationship is between the levels at the same time in the same rat subissue are denied as irrelevant to the response curves for BMD50s and BMD10s when these rats are exposed to conclusions reached in the final rule. (an assertion they have not even made), carbofuran. Petitioners claimed to have The final rule explains why Petitioners’ a showing that EPA’s assumption of done such an analysis and that the arguments are without a basis, and linearity is incorrect can only force EPA analysis showed that within rat Petitioners have failed to address that to abandon the 4X children’s safety inhibition levels in brain and RBC AChE explanation. For essentially the same factor in favor of the default 10X value. were roughly equivalent. Although the reasons, EPA denies the objection. The objection that EPA’s modeling is results of the statistical analyses were For essentially the same reasons, EPA scientifically invalid is denied. EPA’s summarized in the comments, the denies the hearing request and objection modeling has been repeatedly reviewed underlying analysis was not submitted. designated above as Objection/hearing and approved by the SAP, including In the final tolerance revocation request sub issue: Technical Flaws in most recently with respect to the regulation, EPA extensively reviewed EPA’s statistical comparisons. modeling of carbofuran’s dose-response the ‘‘within animal’’ approach and Petitioners’ objection and hearing curves. There is no indication in the rejected it as fundamentally flawed in request on this subissue consist of mere modeling that EPA’s assumption of several regards. Additionally, EPA reiteration of the comments submitted parallel dose-response curves overstates noted that EPA’s review of the in response to the proposed tolerance the difference, and given the absence of Petitioners’ suggested approach showed revocation. The final rule explained the data supplied by Petitioners in support that it produced results, which are in reasons that Petitioners’ arguments are of this objection, the objection is denied. fact consistent with EPA’s conclusions. flawed, and the objections are denied (viii) Subissue: Did EPA err by In their objections, Petitioners do not for the same reasons. combining data from different respond to EPA’s rejection of the within (vii) Subissue: Is EPA’s approach to toxicological studies in calculating the animal approach in the final tolerance comparing brain and RBC AChE estimates of BMD50s that serves as
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quantitative support for derivation of objections to EPA’s assessment of Petitioners’ evidentiary proffer on the the 4X childrens’ safety factor? In its carbofuran levels in drinking water are PGW is internally contradictory given risk assessment, EPA relied on all of the inextricably intertwined with their that Petitioners’ own experts relied on valid data from the available studies to recently-proposed registration the PGW to validate the modeling calculate the estimates that served as the amendments which attempt to create a submitted in support of this objection. PoD, and to calculate BMD50s used in scheme whereby carbofuran use would The objection on this subissue is choosing the children’s safety factor. In be limited in individual watersheds. As denied because timely evidence and their comments on the proposed rule, explained above (see Unit VI.F.2.a), reasoning submitted by Petitioners is Petitioners claimed that EPA’s decision objections based on these recently- contradictory, non-probative, or flatly to combine data for different strains of proposed registration amendments are contradicted by the record. rats, sexes, experiments, laboratories, irrelevant to EPA’s determination in the (ii) Subissue: Does EPA’s assessment dates, dose preparations, rat ages, and final tolerance revocation rule. of carbofuran levels in ground water times between dosing and AChE Nonetheless, in Unit VI.F, EPA account for all of FMC’s label mitigation measurement, is problematic, claiming exhaustively evaluated all of the measures and ‘‘rely on unrealistic and that these differences in study design arguments put forward in Petitioners’ overly conservative assumptions about severely limit the validity of EPA’s drinking water objection and explained potential concentrations’’? In this comparisons and caused EPA to why a hearing was not appropriate on objection, the Petitioners allege that overestimate the difference between any of these arguments and why, on the maximum concentrations of carbofuran brain and RBC AChE inhibition. EPA merits, the arguments were without in groundwater are expected to be below responded to these comments in full basis. Below EPA has summarized its 1.1 ppb, based on their proposed during the rulemaking (74 FR 23052– reasoning. geographic restrictions and well 23053; Ref. 85). Petitioners referenced The first four subissues below pertain setbacks. EPA believes Petitioners’ their earlier comments in their to EPA’s assessment of the carbofuran objection and hearing request on this objections, but presented no further groundwater exposure assessment and subissue is inextricably intertwined evidence on any of these points. Nor in the last eight address the surface water with FMC’s recently-submitted FIFRA their objections and request for hearing assessment. In this regard, it is registration amendments and thus the did Petitioners address EPA’s important to note that, in order to objection is denied as irrelevant on that explanation set forth in the final rule. determine that a tolerance for a account. A hearing is not appropriate on this particular use will be safe, EPA must be Nonetheless, to the extent possible subissue because Petitioners have not able to determine that anticipated EPA has attempted to evaluate this challenged the basis EPA asserted in the concentrations in both surface water objection based on the label mitigation final rule for rejecting their concerns nor and ground water resulting from that measures submitted and adopted prior have they proffered any evidence that use will be safe. to issuance of the final tolerance calls the substance of EPA’s conclusions (i) Subissue: Did EPA err in relying on revocation rule and ruled on it on that into question. A hearing is not the results of the prospective ground basis. EPA denies the objection and its warranted on the basis of mere denials water study (PGW) and historical associated hearing request because or contentions, nor when the monitoring to validate groundwater Petitioners have again failed to object to commenter simply reiterates comments exposure estimate? The Petitioners EPA’s final rule. It is clear from the raised in response to the proposed rule object that EPA should not have relied record that EPA’s final rule and risk (40 CFR 178.32(b)(1) and (2)). for validation on their PGW study or assessment did account for all of the Additionally, this hearing request is historical monitoring data. They argue risk mitigation measures submitted as rejected for lack of materiality. If EPA that these data no longer reflect current part of the September 2008 comments. abandoned its sophisticated analysis of use patterns and that all areas like those Petitioners have not raised any multiple studies and datasets and seen in the PGW have now been substantive challenge to the manner in simply followed the general approach removed from the carbofuran label. which EPA’s modeling addressed those laid out in its BMD policy, EPA would A hearing is not appropriate on this measures. In addition, Petitioners’ have chosen a significantly lower BMD subissue because the Petitioners have objections provide no further dramatically raising EPA’s risk failed to proffer evidence, which would, clarification as to what is meant by their estimates. if established, resolve a material issue in claim that EPA’s assessment relied on Petitioners’ objection on this subissue their favor. First, Petitioners fail to take ‘‘unrealistic and overly conservative is denied because Petitioners have not into account the clear record evidence assumptions.’’ Therefore, this objection, responded to the explanation EPA that EPA scaled the PGW modeling to and the attendant hearing request, is provided in the final rule supporting its reflect the lower current use rates. denied based on Petitioners’ failure to meta-analysis of multiple studies. Second, Petitioners are simply incorrect state with ‘‘particularity * * * the basis Consistent with Agency guidance, EPA to claim that EPA ‘‘validated’’ its for the objection * * *.’’(40 CFR believes that consideration of all quantitative groundwater assessment 178.25(a)(2)). As Petitioners raised available data is the scientifically more based on historic monitoring data that similar allegations in their comments, defensible approach, rather than the are not reflective of current application EPA has assumed that they intended to selective exclusion of reliable data. rates. The targeted monitoring data used incorporate all of the issues raised in the Petitioners’ objection on this point is for validation were based on application comments on the proposed rule. particularly weak given that their rates that are identical or lower than the However, EPA addressed these analysis also combines various data sets current use rates. Third, the majority of assertions in the final rule. Because and only arrives at a higher estimate of Petitioners’ evidence is untimely, and to Petitioners have once again ignored the the BMD by selectively excluding, the extent Petitioners’ are claiming that explanations provided in the final rule, without explanation, the data most the PGW and other targeted monitoring this objection and hearing request are pertinent to assessing carbofuran’s acute data are not reflective of FMC’s June 29, denied as immaterial. affects. 2009 proposed registration (iii) Subissue: Is EPA’s assessment of b. Drinking Water Exposure amendments, that claim is irrelevant to the levels of carbofuran in groundwater Objection—In large part, Petitioners’ the current proceeding. Finally, appropriate given the manner in which
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EPA assessed groundwater exposures in actual carbofuran sales data on a county information that Petitioners submitted the NMC CRA? Petitioners object that basis from 2002-present demonstrate on PCT was not usage data—the type of EPA’s estimates in the final rule are that the current carbofuran PCT is less information normally used in estimating inconsistent with the groundwater than 4.25%. Using this PCT, and taking PCT for food—but sales data. The link concentration estimates EPA developed into account the recently submitted ‘‘no between sales data and the location of for the NMC CRA. However, they do not application buffers,’’ the Petitioners use is tenuous. Given that EPA lacks the identify any specific inconsistency, they allege that the modeling in Exhibit 15 information to allow EPA to generally simply make the general allegation. demonstrates that carbofuran use PCT information in estimating They allege that, by contrast, their concentrations in surface water will not drinking water exposure, and the poor assessment, which estimated maximum exceed 1.1 ppb, ‘‘which is below the quality of information Petitioners concentrations of 1.1 ppb, is consistent level of concern.’’ In support of this submitted on usage (i.e. county-level with the NMC CRA. objection, the Petitioners reference sales data), EPA concludes it could not EPA denies the request for a hearing county level sales data that were make an exposure estimate on on this sub-issue because there is no submitted to the Agency after the close carbofuran in drinking water with disputed factual matter for resolution of the comment period. They also sufficient confidence to meet the (i.e., the manner in which EPA assessed reference the use tracking system FFDCA’s reasonable certainty of no groundwater exposure for carbofuran proposed in their recent registration harm standard. and for the NMCs is a matter of record); amendments (Exhibit 2) and the (v) Subissue: Do the results of FMC rather, the objection poses the legal modeling contained in Exhibit 15. surface water modeling establish that question of whether it was appropriate Because this subissue is inextricably carbofuran levels will not exceed 1.1 for EPA to assess groundwater exposure intertwined with Petitioners’ recently- ppb? The Petitioners claim that the prior for carbofuran and the NMCs in a proposed FIFRA registration surface water assessments submitted to different manner. Further, because amendments, it is denied as irrelevant. the Agency and a new assessment Petitioners have not identified any To the extent Petitioners’ objection on incorporating FMC’s newly-proposed specific inconsistency between the two this subissue is limited to EPA’s refusal FIFRA registration amendments groundwater exposure assessments, it to use a 4% PCT in estimating drinking demonstrate that carbofuran constitutes nothing more than a mere water concentrations in individual concentrations in surface water are not allegation or denial. As EPA’s watersheds based on the information expected to exceed 1.1 ppb. Because regulations make clear, a mere ‘‘denial’’ provided as part of their comments on this subissue is inextricably intertwined of an EPA position is not sufficient to the proposed rule, this objection and with Petitioners’ recently-proposed satisfy the standard for granting a hearing request are also denied as FIFRA registration amendments, it is hearing (40 CFR 178.32(b)(2)). Finally, immaterial. The Petitioners have failed denied as irrelevant. Nonetheless, EPA the claim that their modeling is to respond to EPA’s explanation in the has carefully evaluated all of consistent with the NMC CRA does not final rule that the information and Petitioners’ allegation to determine if justify a hearing on this question. As methodology on which they relied to any of their claims meet the standard for EPA explained in the final rule, the estimate a 4% PCT was fundamentally a hearing or are otherwise meritorious. values estimated in the modeling flawed, and to submit any evidence conducted for the NMC CRA are greater calling the basis of EPA’s response into A hearing is also denied on this sub- than the 1.1 ppb level that FMC claims question (40 CFR 178.32(b)(3)). issue because Petitioners’ objection on is the maximum expected 1-in-10-year Additionally, the proffered evidence this subissue is irrelevant, and therefore peak concentration. A hearing is not here is untimely. The sales data and immaterial, with regard to EPA’s final warranted where the claim is clearly methodology used to generate use tolerance revocation regulation. contradicted by the record (40 CFR estimates, as well as the modeling in Petitioners have not responded to EPA’s 178.32(b)(2)). Exhibit 15, were not submitted during extensive analysis of these studies, On the merits, Petitioners’ objection is the comment period on the proposed which included an explanation for the denied because the results of rule even though the information was Agency’s conclusion that they were Petitioners’ groundwater assessment are clearly available to Petitioners (40 CFR significantly flawed, presented in the not consistent with the estimates 178.32(b)(2)). final rule. The statute, however, requires developed for the NMC CRA. The NMC Petitioners’ objection on this subissue that objections be filed on the final rule CRA examined carbofuran at two sites, is denied because the proffered not the proposal. By ignoring EPA’s northeast Florida and the Delmarva evidence is untimely and, even if final rule on this subissue, Petitioners Peninsula. In Florida, concentrations considered, insufficient. Although EPA have failed to lodge a relevant objection. were found to be below levels of does use reliable data on pesticide usage Both EPA and FDA precedent make concern because of high pH, but in in estimating exposure levels in food, clear that when the agency substantively Delmarva, both in corn and in melon this approach has limited applicability responds to comments on the proposal, scenarios EPA estimated that 90% of in drinking water assessments due to the commenter may only keep that issue daily concentrations could be as high as the differences in the sources of food alive in its objections by addressing the 20.5 and 25.6 ppb, respectively. These and water for consumers. The food agency’s substantive response (40 CFR values are far greater than the 1.1 ppb market in the United States is national 178.32(b)(3)). Similarly, the Petitioners’ that Petitioners claim is the maximum in scope but the sources of drinking new assessment directly relies on FMC’s expected 1-in-10-year peak water are primarily local. Thus, while newly-proposed FIFRA registration concentration. differences in the usage of pesticides amendments and is thus irrelevant to (iv) Did EPA err in not using PCT data across the country will average out in this proceeding. Their new assessment in assessing surface water exposure? estimating pesticide exposure from is also untimely in that it primarily The Petitioners object to the assumption food, such averaging is not applicable to appears to be a fuller description of in the surface water assessments in the estimating pesticide exposure in Petitioners’ National CWS Assessment, final rule that 100% of the crops in a drinking water—i.e., a person’s drinking which was described, but not provided watershed will be treated with water exposure is generally always from as part of their comments on the carbofuran. The Petitioners argue that the same watershed. Moreover, the proposed rule (40 CFR 178.32(b)(2)).
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EPA has outlined the substantial exposure for NMCs (40 CFR by water treatment systems and that the flaws in the previously-submitted 178.32(b)(1)). In addition, this issue was rest of the population is protected by assessments in the final tolerance raised in Petitioners’ comments on the Petitioners’ newly-proposed FIFRA revocation rule and in Unit VI.F, above. proposed revocation. In the final registration amendments. Because this For the all the reasons cited therein, this revocation, EPA explained how the objection is inextricably intertwined objection is denied. substantial differences between a with FMC’s newly-proposed FIFRA (vi) Did EPA inappropriately rely on cumulative risk assessment for a class of registration amendments, it is denied as NAWQA monitoring data in assessing pesticides and a risk assessment for a irrelevant to this proceeding. carbofuran levels in surface water? The single pesticide necessitate different Separating out the allegations that are Petitioners object to EPA’s discussion in approaches. Petitioners have not independent from the new registration the final rule of the high concentrations challenged the substance of EPA’s amendments, EPA denies this hearing detected in Zollner Creek in Oregon and response to their comments or request on the grounds that Petitioners’ claim that EPA inappropriately relied submitted evidence that calls the claims are insufficient to justify the on NAWQA monitoring data in substance of EPA’s final rule action urged (40 CFR 178.32(b)(3)) in estimating surface water exposure levels conclusions into question, and the that they would fail to justify a of carbofuran. A hearing on this issue is objection and associated hearing request conclusion that the carbofuran denied because there are no material is therefore immaterial (40 CFR tolerances are safe. The fact that the factual issues in dispute. The extent to 178.32(b)(3)). Finally, on multiple majority of people are protected is which EPA discussed the Zollner Creek grounds, Petitioners’ evidentiary proffer irrelevant if major identifiable data as part of its discussion of is insufficient to support a conclusion subpopulations are not. Further, both monitoring results from all other that there is a reasonable possibility that the objection and the proffered evidence NAWQA sites, SDWA post-treatment the issue could be resolved in their are untimely because Petitioners’ claims monitoring, and the results of field favor. Petitioners’ objection on this and analyses supporting them were not studies is clear on the record. The subissue is denied for essentially the submitted during the comment period. record is also clear regarding the degree same reasons explained in the final For the same reasons, this objection is of reliance EPA placed on monitoring tolerance revocation. denied. data in estimating carbofuran levels in (ix) Has EPA taken natural surface c. Recovery Time Objection—(i) surface water. The objection on this water pH conditions into account? The Subissue: Has EPA overstated risk subissue is denied because it was Petitioners contend that the PCT levels through its approach to considering reasonable for EPA to consider NAWQA guaranteed by the recently proposed use recovery time to the effects of data in assessing the likelihood that tracking system, along with natural carbofuran? For carbofuran, EPA carbofuran residues may be present in surface water pH conditions in the areas estimated acute dietary exposure for the surface water. Moreover, the record is included under the revised label will acute risk assessment by summing clear that, even though EPA considered ensure that potential exposures are de exposure over a 24-hour period. Because the NAWQA data, it placed primary minimis. Because this objection is humans are likely to recover in a emphasis on the carbofuran levels inextricably intertwined with FMC’s relatively short time period from any detected in post-treatment SDWA newly-proposed FIFRA registration single carbofuran exposure, EPA also monitoring. amendments, it is denied as irrelevant undertook a more sophisticated (vii) Should EPA consider FMC’s to this proceeding. exposure assessment that took recovery newly-proposed terms of registration for Even assuming Petitioners’ allegation time into effect. This more sophisticated carbofuran? The objection is denied concerning soil pH can be separated analysis was not substituted for the 24- because it is based on FMC’s newly from the proposed registration hour assessment approach but rather proposed revisions to its carbofuran amendments, Petitioners’ claims are was used to evaluate whether the 24- registration that were submitted after insufficient to justify the action urged hour approach substantially overstated publication of the final tolerance (40 CFR 178.32(b)(3)). Petitioners admit risk. The reason for not simply adopting revocation rule and is thus irrelevant to that their pH analyses explicitly only the assessment incorporating recovery this proceeding. An additional ground capture 95% of surface waters. Because time was based on concerns that other for denial of this objection and hearing EPA cannot ignore the other 5% of aspects of its exposure model tend to request is that Petitioners proferred no surface water, this information, even if understate exposure. If the assessment evidence to support their allegation that established, would provide an using recovery time had suggested that these proposed requirements would be insufficient basis on which EPA could carbofuran risks may be acceptable, EPA effective in limiting carbofuran reasonably conclude that the drinking would have further examined how exposure to the extent claimed water exposures would be ‘‘safe.’’ exposure should be assessed. However, (viii) Should EPA have used the NMC Additionally, the proffered evidence for because both the assessment based on CRA surface water estimates in this objection is untimely because 24-hour exposure and the one assessing exposure to carbofuran in although the effects of pH were clearly incorporating recovery time showed surface water? Petitioners object to discussed in the proposed rule, carbofuran exposures significantly EPA’s surface water exposure estimates Petitioners’ claim and the analyses exceed the safe level, EPA concluded on the ground that they are inconsistent supporting it were not submitted during that its exposure assessment was with the estimates EPA developed for the comment period. reasonable. Further supporting this purposes of the NMC CRA. This hearing For the same reasons, the Petitioners’ conclusion was the fact that various request is denied because there are no objection is denied. other analyses showed that a single factual matters in dispute; rather, the (x) Has EPA taken the effect of eating occasion could result in excessive only question is a legal one of whether existing drinking water treatment risk to infants. Petitioners have objected it was inappropriate for EPA to use systems into account? The Petitioners to this approach claiming that recovery different approaches to assessing surface contend that, in the areas where time should be included in EPA’s water exposure for the carbofuran carbofuran use is allowed under revised ‘‘primary’’ risk assessment. surface water assessment and the labels, the majority of the total EPA is denying this hearing request cumulative assessment of surface water population is protected from carbofuran on two grounds. First, the objection fails
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to present a disputed issue of material not be granted on this basis (40 CFR did not consider the Arnold study in fact because EPA did incorporate 178.32(b)(2)). light of the animal data; (2) that recovery time into its analysis. Rather, Further, the issue of the appropriate insufficient weight was given prior Petitioners’ only challenge is to whether half-lives for carbofuran is not material. independent reports on the value of the EPA should have only presented risk Petitioners have proffered no evidence Arnold study; (3) that the ‘‘technical’’ estimates that accounted for recovery. to show that reliance on a 150-minute concerns raised by the HSRB are This is a policy issue, and hearings are half-life rather than a 186-minute half- addressed by ‘‘the data within the not appropriate on such (40 CFR life would make a significant difference study’’ and that these ‘‘technical’’ 178.32(b)(1)). to their estimates. By contrast, in the deficiencies do not render the Arnold Second, the fact that EPA relied on risk assessment supporting the final study unreliable. The first proffer is not 24-hour aggregate exposures in addition rule, EPA’s estimates show that the use material because the availability of to analyses that accounted for recovery of a 150-minute or 186-minute half-life animal data does not address the is not material, because even though makes little or no difference. In validity of the Arnold human study. At accounting for recovery resulted in a addition, EPA’s final risk assessment bottom, this issue involves a challenge 2–3X reduction in exposure estimates, found that infants are at risk from a to the policy underlying the Human many of EPA’s estimates for aggregate single exposure. Recovery is only Research rule that allows only limited exposures ranged between 2700% aPAD relevant, by definition, where the risk is consideration of human toxicity studies. and 9400% aPAD for infants. derived from multiple exposures over A hearing is not appropriate on such a Accounting for recovery does not, time. policy issue, nor on the Human therefore, demonstrate that aggregate EPA denies Petitioners’ objection on Research rule itself. Petitioners’ second exposures will be safe for infants. Of this subissue because the evidence proffer is a legal/policy question greater significance in this regard is submitted fails to establish their regarding the weight to be accorded to EPA’s finding that infants are at risk allegations, or to rebut the data and existing peer review reports. No hearing from a single exposure. Recovery is only analyses discussed in the final rule. is required on such issues. To the extent d. Human Study Objection—Issue: relevant, by definition, where the risk is the third proffer even constitutes a Did EPA reasonably conclude that a derived from multiple exposures over proffer of ‘‘evidence,’’ it fails because it human toxicity study with carbofuran time. is nothing more than a mere allegation. was barred from EPA consideration by Petitioners have supplied no Petitioners’ objection to EPA’s policy the Human Research Rule? In information as to how the HSRB’s decision to present acute risks in terms conducting its dietary risk assessment ‘‘technical’’ concerns are resolved by the of 24 hours of exposure is denied for carbofuran, EPA relied on toxicity study itself. because EPA’s policy approach here is data conducted with rats, and applied reasonable. For the reasons explained in the default 10X interspecies factor to Viewed on their merits, these claims Unit VI.G, there are several factors that account for the potential uncertainty in do not convince EPA that it erred in may cause EPA’s exposure/risk model to extrapolating from animal data to determining that the Arnold study did either understate or overstate exposure/ humans. Petitioners object to the not meet the Human Research rule risk. It is unreasonable to present risks decision to use a 10X interspecies factor because it lacked scientific validity. only incorporating factors that tend to claiming that data from a human EPA concluded, based on the advice of reduce exposure/risk estimates (e.g., toxicity study (Arnold) provides a basis the HSRB, that, because the Arnold recovery time), as Petitioners suggest. for reducing this factor to 3X. However, study had an extremely small sample EPA’s approach of evaluating the impact EPA has previously determined that the size (2 persons per dose) and highly that these factors may have on the risk Arnold study lacks scientific validity variable measurement of RBC and assessment is an appropriate method of and thus may not be considered by the plasma AChE, it had no scientific value. taking all relevant factors into account. Agency under EPA’s Human Research The claim by Petitioners that somehow (ii) Subissue: Did EPA err in rule. That decision was based on the the Arnold study could be rehabilitated calculating carbofuran half-lives? In the advice of the HSRB, which found the by considering it in the context of proposed rule, EPA used half-lives of Arnold study to constitute ‘‘poor carbofuran animal data misunderstands 150 minutes and 300 minutes, based on science’’ (Ref. 38 at 11). the issue. The question under the calculations derived for the NMC CRA. Although Petitioners have made a Human Research rule is whether the In the final rule, EPA calculated half- number of arguments in support of human study at issue is scientifically lives specific to carbofuran to ensure adopting a 3X interspecies factor, all of valid. Here, EPA found the Arnold that its analyses accurately reflected the arguments rely on consideration of study to be flawed at its core. Animal carbofuran’s risk. Petitioners contend the Arnold study. Thus, as a data on carbofuran are simply irrelevant that EPA’s calculation of carbofuran preliminary matter, Petitioners must to the problems with sample size and half-lives of 186 minutes and 426 show that a hearing is appropriate based AChE measurement in the Arnold minutes were flawed, and that the data exclusively on whether EPA erred in study. As to the earlier reports on the instead support the use of a 150-minute determining that the Arnold study Arnold study, Petitioners have provided half-life. cannot be considered under the Human no reason as to why these should Petitioners’ hearing requests on this Research rule or, that even if a hearing outweigh the HSRB’s conclusion subissue are denied for two reasons. is not warranted, that EPA’s decision concerning whether the Arnold study First, Petitioners have not provided the under the Human Research rule was met the Human Research rule standard. underlying analyses conducted in incorrect. The earlier reports were completed well support of their claims that the Petitioners have proffered no before the Human Research rule was appropriate half-life for carbofuran is evidence that merits a hearing on EPA’s promulgated and thus could not have 150 minutes, rather than the 186 or 426 application of the Human Research rule addressed the rule’s requirements. minutes that EPA calculated. to the Arnold study. As an evidentiary Further, the earlier reports identified the Petitioners’ evidentiary proffer thus proffer, Petitioners claim (1) that review same defects, but concluded that the consists of no more than mere of the Arnold study under the Human Arnold’s study’s flaws could be allegations and denials. Hearings will Research rule was too narrow in that it addressed by the use of additional safety
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factors—an option not available under because this action is not a rule for Exhibit 8 the Human Research rule. In such purposes of 5 U.S.C. 804(3). • circumstances, it was reasonable for Dose Response Modeling Issue in IX. References EPA to give primary weight to the HSRB Carbofuran by Sielken: Statistical findings. Petitioners’ claim that the EPA has established an official record Comparison of AChE Inhibition in RBC HSRB only identified ‘‘technical’’ for this rulemaking. The official record and Brain in Rats Exposed to problems with the Arnold study and includes all information considered by Carbofuran. that the study itself addresses the EPA in developing this proposed rule Exhibit 9 HSRB’s concerns is without basis. The including documents specifically • flaws in the Arnold study are not referenced in this action and listed Dose Response Modeling Issue in technical but fundamental, and cannot below, any public comments received Carbofuran by Sielken: OPP’s Estimates be explained away. Finally, Petitioners’ during an applicable comment period, of the Half-Life of AChE Recovery. allegations that EPA hampered the and any other information related to this Exhibit 10 HSRB’s consideration of the prior peer action, including any information review reports and that EPA’s recusal claimed as CBI. This official record • Reiner, 1971. Spontaneous decision was somehow improper are includes all information physically Reactivation of Phosphorylated and contradicted by the record. Accordingly, located in docket ID number EPA–HQ– Carbamylated Cholinesterases Bulletin the objection is denied. OPP–2005–0162, as well as any WHO 44, 109–112. e. Import Tolerance Objection—Issue: documents that are referenced in the Exhibit 11 Did EPA err by failing to retain the documents listed below or in the carbofuran tolerances that apply solely docket. The public version of the official • Carbofuran Dietary Risk to imported food. Whether EPA had record does not include any information Assessment. 2009. (Exponent Inc., for some type of independent duty to retain claimed as CBI. FMC) carbofuran tolerances for the imported Objections to the Final Order Exhibit 12 foods bananas, rice, coffee, and Revoking Tolerances for Carbofuran, sugarcane despite its finding that and Request for Public Evidentiary • Williams, Cheplick, Engle, Fawcett aggregate exposure to carbofuran is Hearing, submitted by National Potato and Hoogeweg. 2009. National unsafe, is a legal question. Hearings are Council, National Corn Growers Carbofuran Leaching Assessment. Vol 1. not held on legal issues. Having found Association, National Cotton Council, Waterborne Environmental Inc., Engel that aggregate exposure to carbofuran is National Sunflower Association, and Consulting, and Fawcett Consulting for unsafe, EPA was clearly warranted, if FMC Corporation. June 30, 2009. EPA– FMC. not required, to revoke all tolerances. HQ–OPP–2005–0162–0578. Exhibit 13 For the policy reasons identified above, Exhibit 1 (see Unit VI.I), when aggregate risk to a • • Williams, Cheplick, Engle, Fawcett pesticide is unsafe, EPA defers to FMC’s letter of 9–29–08 and and Hoogeweg. 2009. National interested parties to decide in the first accompanying label amendments. Carbofuran Leaching Assessment. Vol 2. instance what tolerances, if any, they Exhibit 2 Setback Analysis. Waterborne wish to retain. Although explicitly • FMC’s letter of 12–24–08 and Environmental Inc., Engel Consulting, invited to do so, no person submitted a accompanying label amendments. and Fawcett Consulting for FMC. comment on the proposed revocation that identified the import tolerances as Exhibit 3 Exhibit 14 a subset of tolerances that were asserted • FMC’s letter of 6–30–09 and • Memorandum. From: Hoogeweg to be safe, and that the commenter accompanying label amendments. and Williams, Waterborne, Inc., To: wished to retain. Accordingly, this Fuge, Latham and Watkins, LLP. June objection is denied. Exhibit 4 30, 2009. Subject: Groundwater pH in • K. Conclusion Expert Report: Carbofuran’s FQPA selected states. Safety Factor and Interspecies Exhibit 15 For all of the reasons set forth above, Uncertainty Factor by K. Wallace (6 p.) EPA denies the Petitioners’ objections • 13 published articles on pesticide • Williams, Fawcett and Engle. 2009. and their requests for a hearing on those effect on cholinesterase activity. The Development and Evaluation of a objections. Exhibit 5 Carbofuran Management Plan to Protect VII. Regulatory Assessment • Drinking Water Derived from Surface Requirements Central Nervous System as the Water Sources. Waterborne Primary Target for Carbofuran’s Effects Environmental Inc., for FMC. As indicated previously, this action on Lip Smacking by Neal, Williams, & announces the Agency’s final order Lamb (3 p.) Exhibit 16 regarding objections filed under section • 10 published articles on effects of • Memorandum. From: Hoogeweg 408 of FFDCA. As such, this action is an cholinergic stimulation. adjudication and not a rule. The and Williams, Waterborne, Inc., To: regulatory assessment requirements Exhibit 6 Fuge, Latham and Watkins, LLP. June imposed on rulemaking do not, • Expert Report: Carbofuran FQPA 30, 2009. Subject: Surface water pH in therefore, apply to this action. Safety Factor by K. Wallace (8 p.) selected states. • 9 published articles on HBC versus VIII. Submission to Congress and the Exhibit 17 brain cholinesterase inhibition. Comptroller General • Memorandum. From: Williams, The Congressional Review Act, (5 Exhibit 7 Waterborne, Inc., To: Fuge, Latham and U.S.C. 801 et seq.), as added by the • Dose Response Modeling Issue in Watkins, LLP. June 30, 2009. Subject: Small Business Regulatory Enforcement Carbofuran by Sielken: AChE and BMD Water Treatment Assessment in Fairness Act of 1996, does not apply Ratios Carbofuran Use States.
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Exhibit 18 prepared by Quincy Research Center, 25. Dose-Time Response Modeling of Rat submitted by FMC Corp., Philadelphia, Pa.; RBC AChE Activity: Carbofuran Gavage • Petition of the National Corn CDL:241305–A) Accession no. 241305, MRID Dosing: BMD50s for PND11 Animals, January Grower’s Association, the National no. 00092829. EPA–HQ–ORD–2006–0310– 14, 2009. EPA–HQ–OPP–2005–0162–0570. Sunflower Association, the National 0020. 26. El-Naggar AEl-R, Abdalla MS, El- Potato Council, and FMC Corporation to 10. Benjamins, J.A. and McKhann, G.M. Sebaey AS, Badawy SM. (2009) Clinical Defer the Effective Date of Certain (1981) Development, regeneration, and aging findings and cholinesterase levels in children Tolerance Revocations for Carbofuran. of the brain. In: Basic Neurochemistry, 3rd of organophosphates and carbamates edition. Edited by Siegel, G.J., Albers, R.W., poisoning. Eur. J. Pediatrics 168: 951–956. References Agranoff, B.W., and Katzman, R. Little, 27. Engel, Bernard, Richard S. Fawcett, and Brown and Co., Boston. pp 445–469. W. Martin Williams. 2008. Comments to the 1. Acute oral (gavage) dose range-finding 11. Bretaud S, Toutant JP, Saglio P. 2000. study of cholinesterase depression from FIFRA Scientific Advisory Panel—Volume V.: Effects of carbofuran, diuron, and The Water Risk Assessment for Carbofuran. carbofuran technical in juvenile (day 11) rats. nicosulfuron on acetylcholinesterase activity Hoberman, 2007. MRID 47143703 From Carbofuran Scientific Advisory Panel in goldfish (Carassius auratus). Ecotoxicol Meeting, Feb. 5–8, 2008, Docket ID Number: (unpublished FMC study) EPA–HQ–OPP– Environ Saf. 2000 Oct.; 47(2):117–24. 2007–1088–0062. EPA–HQ–OPP–2007–1088 FMC Corporation, 12. Carbofuran Acute Aggregate Dietary Agricultural Products Group Written 2. Acute oral (gavage) time course study (Food and Drinking Water) Exposure and and final report of cholinesterase depression Comments. Risk Assessments for the Reregistration 28. EPA Response to the Transmittal of from carbofuran technical in adult and Eligibility Decision (T. Morton, 7/22/08, juvenile (day 11 postpartum) rats. Hoberman, Meeting Minutes of the FIFRA Scientific D351371). EPA–HQ–OPP–2005–0162–0508. Advisory Panel Meeting Held February 5–8 2007. MRID 47143704, 05 (unpublished FMC 13. Carbofuran Environmental Risk studies) EPA–HQ–OPP–2007–1088–0063 and 2008 on the Agency’s Proposed Action under Assessment and Human Drinking Water FIFRA 6(b) Notice of Intent to Cancel –0066. Exposure Assessment for IRED. March 2006. 3. Acute time-course study of carbofuran Carbofuran (E. Reaves, A. Lowit, J. Liccione EPA–HQ–OPP–2005–0162–0080. 7/2008 D352315). EPA–HQ–OPP–2005– technical administered by gavage to adult 14. Carbofuran. HED Revised Risk and postnatal day 11 male and female CD 0162–0505. Assessment for the Reregistration Eligibility 29. Fawcett, R., B. Engel, W. Williams. (Sprague-Dawley) rats: Tyl, Marr, and Myers. Decision (RED) Document (Phase 6). (PC 2005. (Unpublished study received Nov. 14, 2007. An Investigation into the Potential for 090601) D 330541, July 26, 2006. EPA–HQ– Carbofuran Leaching to Ground Water Based 2005; prepared by RTI International, RTP, OPP–2005–0162–0307. NC; submitted by FMC Corp., Philadelphia, on Historical and Current Product Uses. 15. Carbofuran. HED Revised Risk (MRID 47221602) Project Number PC/0363. Pa.; FMC Study No: A2005–5982. MRID Assessment for the Notice of Intent to Cancel. 32 p. EPA–HQ–OPP–2005–0162–0454.1 46688913. EPA–HQ–OPP–2005–0162–0058. (PC 090601) D 347038, January 2007. EPA– 30. FIFRA SAP (1998) ‘‘A set of Scientific 4. Acute dose-response study of carbofuran HQ–OPP–2007–1088–0034. Issues Being Considered by the Agency in technical administered by gavage to adult 16. Carr, Chambers, Guarisco, Richardson, Connection with Proposed Methods for and postnatal day 11 male and female CD Tang, and Chambers. 2001. Effects of Basin-scale Estimation of Pesticide (Sprague-Dawley) rats: Tyl and Myers. 2005. repeated oral postnatal exposures to MRID 46688914. EPA–HQ–OPP–2005–0162– chlorpyrifos on open-field behavior in Concentrations in Flowing Water and 0078. juvenile rats. Toxicol. Sci. 59: 260–267. Reservoirs for Tolerance Reassessment.’’ 5. Anderson, S. A. (2002). The 17. Chen, W.L., Sheets, Nolan and Mattson. Final Report from the FIFRA Scientific Toxicokinetics of Peripheral Cholinesterase 1999. Human red blood cell Advisory Panel Meeting of July 29–30, 1998 Inhibition from Orally Administered acetylcholinesterase inhibition as the (Report dated September 2, 1998). Available Carbofuran in Adult Male and Female CD appropriate and conservative surrogate at: http://www.epa.gov/scipoly/sap/meetings/ Rats. (Unpublished study received May 15, endpoint for establishing chlorpyrifos 1998/july/final1.pdf. 2002; prepared by Toxicokinetics Laboratory, refernce dose. Regul. Toxicol. ′Pharmacol. 29, 31. FIFRA SAP (1999) ‘‘Sets of Scientific RTP, NC; submitted by FMC Corp., 15–22. Issues Being Considered by the Philadelphia, Pa.; FMC Study No: A2001– 18. Comments in Opposition to Proposed Environmental Protection Agency Regarding 5379. MRID 456757–01. Tolerance Revocations for Carbofuran. Use of Watershed-derived Percent Crop Areas 6. An Investigation into the Potential for (September 29, 2008). Submitted by the as a Refinement Tool in FQPA Drinking Carbofuran Leaching to Ground Water Based National Potato Council, National Corn Water Exposure Assessments for Tolerance on Historical and Current Use Practices. Growers Association, National Cotton Coucil, Reassessment.’’ Final Report from the FIFRA Submitted by FMC Corporation, National Sunflower Association, and FMC Scientific Advisory Panel Meeting of Philadelphia, PA.: Report No. PC–0363. Corporation. EPA–HQ–OPP–2005–0162– February 5–7, 2002 (Report dated May 25, MRID 47221602. EPA–HQ–OPP–2007–1088– 0547.1. 1999). SAP Report 99–03C. Available at: 0022. 19. Costa, Hand, Schwab, and Murphy. http://www.epa.gov/scipoly/sap/meetings/ 7. Arnold, J.D. (1976) Evaluation of the 1981a. Reduced [3H] quinuclidinyl benzilate 1999/may/final.pdf. Safe Exposure Levels to Carbamate, binding to muscarinic receptors in 32. SAP. 2001a. REPORT: FIFRA Scientific Administered Orally to Healthy Adult disulfoton-tolerant mice. Toxicol. Appl. Advisory Panel Meeting, September 29, 2000, Normal Male Volunteers. (Unpublished study Pharmacol. 60: 441–450. held at the Sheraton Crystal City Hotel, received Oct. 24, 1979 under 279– 2712; 20. Costa, Hand, Schwab, and Murphy. Arlington, Virginia. Session VI–A Set of prepared by Quincy Research Center, 1981b. Tolerance to the carbamate insecticide Scientific Issues Being Considered by the submitted by FMC Corp., Philadelphia, Pa.; propoxur. Toxicology. 21: 267–278. Environmental Protection Agency Regarding: CDL:241303–B) Accession no. 241303. MRID 21. Costa and Murphy. 1983. Progress Report on Estimating Pesticide 00092826. EPA–HQ–ORD–2006–0310–0020. Unidirectional cross-tolerance between the Concentrations in Drinking Water and 8. Arnold, J.D. (1977) Carbamate carbamate insecticide propoxur and the Assessing Water Treatment Effects on (Carbofuran) Human Dermal Study. Final organophosphate disulfoton in mice. Fund. Pesticide Removal and Transformation: A rept. (Unpublished study received Oct. 24, Appl. Toxicol. 3: 483–488. Consultation. SAP Report No 2002–2. 1979 under 279–2712; prepared by Quincy 22. Davison, A.N. and Dobbing, J. (1966) 33. FIFRA SAP. (2002a). ‘‘Methods Used to Research Center, submitted by FMC Corp., Myelination as a vulnerable period in brain Conduct a Preliminary Cumulative Risk Philadelphia, Pa.; CDL:241303–C), Accession development. Br. Med. Bull. 22: 40–44. Assessment for Organophosphate no. 241303. MRID 00092827. EPA–HQ–ORD– 23. Dobbing, J. and Smart, J.L. (1974) Pesticides.’’ Final Report from the FIFRA 2006–0310–0020. Vulnerability of developing brain and Scientific Advisory Panel Meeting of 9. Arnold, J.D. (1978) Comparison of behaviour. Br. Med. Bull. 30: 164–168; February 5–7, 2002 (Report dated March 19, Cholinesterase Inhibition and Effects of 24. Dose-Time Response Modeling of Rat 2002). FIFRA Scientific Advisory Panel, Furadan 4F and FMC 35001 4 EC (ACT Brain AChE Activity: Carbofuran Gavage Office of Science Coordination and Policy, 152.03). Rev. final rept. (Unpublished study Dosing: BMD50s for PND11 animals, January Office of Prevention, Pesticides and Toxic received Oct. 24, 1979 under 279–2712; 14, 2009. EPA–HQ–OPP–2005–0162–0571. Substances, U.S. Environmental Protection
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Agency. Washington, DC. SAP Report 2002– Andreasen and Danette Drew dated October Corporation, Philadelphia, PA. WEI Report 01. 23, 2007. EPA–HQ–OPP–2005–0162–0486. No. 528.01–B, FMC Report No. PC–0387. 34. FIFRA Science Advisory Panel (SAP). 45. Jones, R. David. 2007b. Summary MRID 47272301. EPA–HQ–OPP–2007–1088– 2005a. ‘‘Final report on N-Methyl Carbamate Evaluation of Recently Submitted FMC Water 0024. Cumulative Risk Assessment: Pilot Exposure Studies. (DP 347901) Internal EPA 58. National Resources Inventory 1992, Cumulative Analysis.’’ Final Report from the Memorandum to Jude Andreasen dated cited in USGS 2002, ‘‘Herbicide FIFRA Scientific Advisory Panel Meeting of December 26, 2007. Available in the federal Concentrations in the Mississippi River February, 2005 (Report dated September 2, docket at www.regulations.gov at EPA–HQ– Basin—the importance of chloracetanilide 1998). Available at: http://www.epa.gov/ OPP–2007–1088–0016. degradates.’’ R.A. Rebich, R.H. Coupe, scipoly/sap/2005/february/minutes.pdf. 46. Jones, R. David (2008a) (5/1/2008). E.M.Thurman. 35. FIFRA Science Advisory Panel (SAP). Additional refinements for estimations of 59. Nostrandt, A.C., Padilla, S., and Moser, 2005b. ‘‘Final report on Preliminary N– drinking water exposure from carbofuran use V.C. (1997). The relationship of oral Methyl Carbamate Cumulative Risk on corn. (DP 351653). EPA–HQ–OPP–2005– chlorpyrifos effects on behavior, Assessment.’’ Final Report from the FIFRA 0162–0569. cholinesterase inhibition, and muscarinic Scientific Advisory Panel Meeting of July 29– 47. Jones, R. David. 2008b. Additional receptor density in rat. Pharmacol. Biochem. 30, 1998 (Report dated September 2, 1998). Refinements of the Drinking Water Exposure Behav. 58, 15–23. Available at: http://www.epa.gov/scipoly/ Assessment for the Use of Carbofuran on 60. Ott, Wayne R. 1995. Environmental sap/2005/august/minutes.pdf. Corn and Melons. (DP 353714) Internal EPA Statistics and Data Analysis. CRC Press. Boca 36. FIFRA Science Advisory Panel (SAP). Memorandum to Jude Andreasen and Raton, Florida. 2008. ‘‘Final report on the Agency’s Proposed Thurston Morton, dated June 23, 2008. EPA– 61. Padilla S, Marshall RS, Hunter DL, Action under FIFRA 6(b) Notice of Intent to HQ–OPP–2005–0162–0510. Oxendine S, Moser VC, Southerland SB, Cancel Carbofuran.’’ Report from the FIFRA 48. Jones, R. David. (2008c) Updated Mailman RB. 2005. Neurochemical effects of Scientific Advisory Panel Meeting of Refinements of the Drinking Water Exposure chronic dietary and repeated high-level acute February, 5–8 2008 (Report dated September Assessment for the Use of Carbofuran on exposure to chlorpyrifos in rats. Toxicol Sci. 2, 1998). Available at: http:// Corn and Melons, 8/18/2008. (DP 355584) 2005 Nov;88(1):161–71. www.epa.govscipoly/sap/meetings/2008/ Internal EPA Memorandum to Jude 62. Padilla S., Marshall R.S., Hunter D.L., february/carbofuransapfinal.pdf. Andreasen and Thurston Morton, dated and Lowit A. 2007. Time course of 37. Hoberman, A. M. (1998). August 18, 2008. EPA–HQ–OPP–2005–0162– cholinesterase inhibition in adult rats treated Developmental Neurotoxicity Study of 0516. acutely with carbaryl, carbofuran, Chlorpyrifos Administered Orally via Gavage 49. Lauzon, John D., Ivan P. O’Halloran, formetanate, methomyl, methiocarb, oxamyl, or propoxur. Toxicology and Applied to Crl:CDBR VAF/Plus Presumed Pregnant David J. Fallow, A. Peter von Bertoldi, and Pharmacology, 219; 202–209. Rats. EPA—MRID No. 44556901. Dow Doug Aspinall. 2005. Spatial Variability of 63. PND17 BMDs and BMDLs and recovery Chemical Co., Midland, MI. Soil Test Phosphorus, Potassium, and pH of half-lives for the effects of carbofuran on 38. HSRB Meeting Minutes. June 1, 2006. Ontario Soils. Agronomy Journal 97:524–532. brain and blood AChE (PND17_DR.pdf). Minutes of the United States Environmental 50. Lifshitz, Shahak, Bolotin, and Sofer. EPA–HQ–OPP–2007–1088–0047. Protection Agency (EPA) Human Studies 1997. Carbamate Poisoning in Early 64. Richardson, J., and Chambers, J. (2003). Review Board (HSRB) May 2–3, 2006 Public Childhood and in Adults. Clinical Effects of gestational exposure to chlorpyrifos Meeting Docket Number: EPA–HQ–ORD– Toxicology. 35: 25–27. on postnatal central and peripheral 2006–0310. http://www.epa.gov/osa/hsrb/ 51. Marable BR, Maurissen JP, Mattsson JL, cholinergic neurochemistry. J Toxicol files/meeting-materials/may-2-3-2006-public- Billington R. 2007. Differential sensitivity of Environ Health A 66, 275–89. meeting/mayminutesfinal.pdf. blood, peripheral, and central cholinesterases 65. Richardson, J., and Chambers, J. 2005. 39. HSRB Memorandum: Farland to HSRB in beagle dogs following dietary exposure to Effects if repeated oral postnatal exposure to Board. May 1, 2006 ‘‘Ethics Determination for chlorpyrifos. Regul Toxicol Pharmacol. 2007 chlorpyrifos on cholinergic neurochemistry Participation at the May 2–3, 2006 EPA Apr;47(3):240–8. in developing rats. Toxicol Sci 84, 352–59. Human Studies Review Board Meeting.’’ 52. Mattsson, J. L., Maurissen, J. P., Nolan, 66. Report on cholinesterase sensitivity 40. HSRB Report. July 7, 2006. R. J., and Brzak, K. A. 2000. Lack of study of carbofuran: Adult and PND11 MRID Memorandum from Fisher to Gray. Subject: differential sensitivity to cholinesterase 47289001 (ORD study). EPA–HQ–OPP–2007– May 2–3, 2006 EPA Human Studies Review inhibition in fetuses and neonates compared 1088–0065. Board Meeting Report. http://www.epa.gov/ to dams treated perinatally with chlorpyrifos. 67. Revised Drinking Water Assessment in osa/hsrb/files/meeting-materials/may-2-3- Toxicol Sci 53, 438–46. Support of the Reregistration of Carbofuran 2006-public-meeting/final7706.pdf. 53. McDaniel K.L. and Moser V.C. (2004) (PC Code 090601) (R. David Jones, 9/5/07 41. Hunter, D. L., Lassiter, T. L., and Differential profiles of cholinesterase D3424057). EPA–HQ–OPP–2005–0162–0485. Padilla, S. 1999. Gestational exposure to inhibition and neurobehavioral effects in rats 68. Rupniak, NM, Jenner, P and Marsden, chlorpyrifos: comparative distribution of exposed to fenamiphos or profenofos. CD. 1983. Cholinergic manipulation of trichloropyridinol in the fetus and dam. Neurotoxical Teratol. 26:407–415. perioral behaviour induced by chronic Toxicol. Appl. Pharmacol. 158, 16–23. 54. McDaniel K.L., Padilla S., Marshall neuroleptic administration to rats. 42. Issue Paper for the FIFRA SAP Meeting R.S., Phillips P.M., Podhorniak L., Qian Y., Psychopharmacology 79 (2–3): 226–230. on Carbofuran: Human Health Risk Moser V.C. (2007) Comparison of acute 69. Screening Level analysis of the small Assessment Reregistration Eligibility Science neurobehavioral and cholinesterase business impacts of revoking carbofuran Chapter for Carbofuran, Environmental Fate inhibitory effects of N-methyl carbamates in tolerances. (Wyatt, T.J. July 2008) 28 pgs. and Effects Chapter. March 2006. EPA–HQ– rats. Toxicol. Sci. 98, 552–560. EPA–HQ–OPP–2005–0162–0506. OPP–2007–1088–0031. 55. Morton, T., 4/29/09, D358037, 70. Setzer W. October 5, 2007. Dose-time 43. Jones, R. David, Sidney Abel, William Carbofuran Acute Aggregate Dietary (Food response modeling of rat brain AChE activity: Effland, Robert Matzner, and Ronald Parker. and Drinking Water) Exposure and Risk Carbofuran gavage dosing. 64 pgs. EPA–HQ– 1998. Proposed Methods for Basin-scale Assessments for the Reregistration Eligibility OPP–2007–1088–0053. Estimation of Pesticide Concentrations in Decision. 71. Schwab, Hand, Costa and Murphy. Flowing Water and Reservoirs for Tolerance 56. Moser V.C. (1995) Comparisons of the 1981. Reduced Muscarinic Receptor Binding Reassessment: Chapter IV., An Index acute effects of cholinesterase inhibitors in Tissues of Rats Tolerant to the Insecticide Reservoir for Use in Assessing Drinking using a neurobehavioral screening battery in Disulfoton. Neurotoxicology. 2: 635–647. Water Exposure. Presentation to the FIFRA rats. Neurotoxical Teratol 17: 617–625. 72. Somani, S. M. and Dube, S. N. 1989. Science Advisory Panel, July 29–30, 1998. 57. National Assessment of the Relative In vivo dose response relationship between 44. Jones, R. David. 2007a. Additional Vulnerability of Community Water Supply physostigmine and cholinesterase activity in chemographs for potatoes and cucurbits for Reservoirs in Carbofuran Use Areas. RBC and tissues of rat. Life Science 44, 1907– drinking water exposure assessment in Performed by Waterborne Environmental 1915. support of the reregistration of carbofuran. Inc., Leesburg, VA and Engel Consulting, 73. Thelin, Gail P., and Leonard P. Internal EPA Memorandum to Jude West Lafayette, IN. Submitted by FMC Gianessi. 2000. Method for Estimating
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Pesticide Use for County Areas of the Pesticide Programs,’’ September 24, 2007. blood samples at delivery among urban Conterminous United States. U.S. Geological Available at: http://www.epa.gov/oppsrrd1/ minority mothers and newborns. Survey Open-File Report 00–250. REDs/nmc_revised_cra.pdf. Environmental Health Perspectives, vol. 111, Sacramento, California, 2000. Available at: 82. USEPA (2007b). Carbaryl. HED Chapter num. 5, pp. 749–756. http://water.usgs.gov/nawqa/pnsp/pubs/ of the Reregistration Eligibility Decision 89. Williams, W. M., (2007a) B. Engel, S. ofr00250. Document (RED). PC Code: 056801, DP Dasgupta, and C. G. Hoogeweg. An In-Depth 74. Trask, Jennifer R., and Joshua Amos. Barcode: D334770. 28 June 2007. EPA–HQ– Investigation to Estimate Surface Water 2005. Watershed Regressions for Pesticides OPP–2007–0941–0003. Concentrations of Carbofuran within Indiana (WARP) for Carbofuran in Illinois 83. U.S. Environmental Protection Agency. Watersheds. Prepared by Waterborne 2008a. EPA response to the transmittal of Community Water Supplies. (MRID Environmental Inc., Leesburg, VA. WEI meeting minutes of the FIFRA Scientific 47221603) Performed by Waterborne 362.07. (MRID 46688915) Submitted by FMC Advisory Panel Meeting held February 5–8 Environmental, Inc., Leesburg, VA, Engel Corporation, Philadephia, PA FMC Study on the Agency’s proposed action under Consulting, and Fawcett Consulting. #P3786. EPA–HQ–OPP–2005–0162–0061. FIFRA 6(b) Notice of Intent to Cancel Submitted by FMC Corporation, 75. USEPA (2000a) ‘‘Assigning Values to Carbofuran (3–26–08). E. Reaves et al., July Philadelphia, PA. WEI No 528.01, FMC Nondetected/Nonquantified Pesticide 22, 2008, DP 352315. EPA–HQ–OPP–2005– Report No. PC–0378. EPA–HQ–OPP–2005– Residues in Human Health Dietary Exposure 0162–0505. 0162–0453. Assessments.’’ March 23, 2000. Available at: 84. USEPA (2009a) Jones, R. David, Reuben 90. Williams, W. M. (2007b) B. Engel, J. http://www.epa.gov/pesticides/trac/science/ Baris, and Marietta Echeverria. 2009. Amos, and C. G. Hoogeweg. National trac3b012.pdf. Response to comments on EPA’s proposed Assessment of the Relative Vulnerability of 76. USEPA. (2000b). ‘‘Benchmark Dose tolerance revocations for carbofuran Community Water Supply Reservoirs in Technical Guidance Document.’’ Draft report. specifically related to drinking water Carbofuran Use Areas. (MRID 47272301) Risk Assessment Forum, Office of Research exposure assessment. Internal EPA Performed by Waterborne Environmental, and Development, U.S. Environmental memorandum to Jude Andreasen dated April Inc.and Engel Consulting. Submitted by FMC Protection Agency. Washington, DC. EPA/ 29, 2009. D362182. EPA–HQ–OPP–2005– 630/R–00/001. 0162–0565. Corporation, Philadelphia, PA. EPA–HQ– 77. USEPA. (2000c) ‘‘Choosing a Percentile 85. USEPA (2009b) Response to Comments OPP–2005–0162–0463. of Acute Dietary Exposure as a Threshold of in Opposition to Proposed Tolerance 91. Zwiener RJ, Ginsburg CM. (1988) Regulatory Concern.’’ March 16, 2000. Revocations for Carbofuran Docket EPA–HQ– Organophosphate and carbamate poisoning Available at: http://www.epa.gov/pesticides/ OPP–2005–0162’’ submitted by the National in infants and children. Pediatrics 81:121– trac/science/trac2b054.pdf. Potato Council, National Corn Growers 126. 78. USEPA. (2000d). ‘‘The Use of Data on Association, National Cotton Council, 92. Vecchia, A.V. and Crawford, C. G. Cholinesterase Inhibition for Risk National Sunflower Association, and FMC (2006). Simulation of Daily Pesticide Assessments of Organophosphorous and Corporation (September 29, 2008). April 29, Concentrations From Watershed Carbamate Pesticides.’’ August 18, 2000. 2009. EPA–HQ–OPP–2005–0162–0567. Characteristics and Monthly Climatic Data Available at: http://www.epa.gov/pesticides/ 86. Watershed Regressions for Pesticides USGS Scientific Investigations. USGS Report trac/science/cholin.pdf. (WARP) Model Estimates for Carbofuran in 2006–5181. 60 pgs. 79. USEPA. (2002). ‘‘Office of Pesticide Illinois Watershed. Performed by Waterborne Programs’ Policy on the Determination of the Environmental, Inc., Leesburg, VA. WEI List of Subjects in 40 CFR Part 180 Appropriate FQPA Safety Factor(s) For Use 362.07. Submitted by FMC Corporation, in Tolerance Assessment.’’ Available at: Philadelphia, PA. Report No. P–3786. MRID Environmental protection, http://www.epa.gov/oppfead1/trac/science/ 46688915. EPA–HQ–OPP–2007–1088–0021. Administrative practice and procedure, determ.pdf. 87. WHO JMPR, 1999. FAO/WHO Joint Agricultural commodities, Pesticides 80. USEPA Peer Review Handbook 3rd Meeting on Pesticide Residues. Report of the and pests, Reporting and recordkeeping Edition. 2006. Prepared for the U.S. 1998 FAO/WHO Joint Meeting on Pesticide requirements. Environmental Protection Agency by Residues. Food and Agriculture Members of the Peer Review Advisory Group, Organization-United Nations. Rome, Italy. Dated: October 30, 2009. for EPA’s Science Policy Council http:// http://www.fao.org. Debra Edwards, www.epa.gov/peerreview/. 88. Whyatt, R., Barr, D., Camann, D., Director, Office of Pesticide Programs. 81. USEPA (2007a). ‘‘Revised N–Methyl Kinney, P., Barr, J., Andrews, H., et al. Carbamate Cumulative Risk Assessment U.S. (2003). Contemporary-use pesticides in [FR Doc. E9–27261 Filed 11–17–09; 8:45 am] Environmental Protection Agency, Office of personal air samples during pregnancy and BILLING CODE 6560–50–P
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Part III
Department of Education 34 CFR Subtitle B, Chapter II Race to the Top Fund; Final Rule
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DEPARTMENT OF EDUCATION We published a notice of proposed governors, chief State school officers, priorities, requirements, definitions, and teachers, and principals weighed in 34 CFR Subtitle B, Chapter II selection criteria (NPP) for this program with suggestions and critiques. All told, in the Federal Register on July 29, 2009 individuals from all 50 States and the [Docket ID ED–2009–OESE–0006] (74 FR 37804). That notice contained District of Columbia, including over 550 RIN 1810–AB07 background information and our reasons individuals and 200 organizations, for proposing the particular priorities, commented on the NPP. Race to the Top Fund requirements, definitions, and selection The extensive and thoughtful public criteria. commentary on the NPP has been AGENCY: Department of Education. There are a number of differences invaluable in helping the Department ACTION: Final priorities, requirements, between the NPP and this notice of final revise, improve, and clarify the definitions, and selection criteria. priorities, requirements, definitions, and priorities, requirements, definitions, and selection criteria as discussed in the selection criteria for the Race to the Top Catalog of Federal Domestic Analysis of Comments and Changes program. A discussion of the most Assistance (CFDA) Number: 84.395A. section elsewhere in this notice. significant changes follows. SUMMARY: The Secretary of Education Public Comment: (Secretary) announces priorities, In response to our invitation in the Major Changes in the Selection Criteria, requirements, definitions, and selection NPP, 1,161 parties submitted comments Priorities, Requirements, and criteria for the Race to the Top Fund. on the proposed priorities, Definitions The Secretary may use these priorities, requirements, definitions, and selection State Success Factors requirements, definitions, and selection criteria. criteria in any year in which this Generally, we do not address Many of the commenters expressed program is in effect. technical and other minor changes, nor concern that the NPP’s encouragement of comprehensive and coherent DATES: Effective Date: These priorities, do we address suggested changes that statewide reform was undercut by the requirements, definitions, and selection the law does not authorize us to make need for State applicants to organize criteria are effective January 19, 2010. under the applicable statutory authority. In addition, we do not address general their plans around each of the four FOR FURTHER INFORMATION CONTACT: reform assurances, one at a time. In James Butler, U.S. Department of comments that raised concerns not directly related to the NPP. response to this concern, the Education, 400 Maryland Ave., SW., Department has reorganized a number of room 3E108, Washington, DC 20202– Introduction the criteria, moving key criteria from the 6400. Telephone: 202–205–3775 or by The Race to the Top program, a $4.35 Overall section to a new section at the e-mail: [email protected]. billion fund created under the American beginning of the selection criteria called SUPPLEMENTARY INFORMATION: Recovery and Reinvestment Act of 2009 State Success Factors. This new section Purpose of Program: The purpose of (ARRA), is the largest competitive provides States with the opportunity to the Race to the Top Fund, a competitive education grant program in U.S. history. start their proposals with clear grant program, is to encourage and The Race to the Top Fund (referred to statements of their coherent, reward States that are creating the in the ARRA as the State Incentive coordinated, statewide reform agendas. conditions for education innovation and Grant Fund) is designed to provide As several commenters noted, States reform; achieving significant incentives to States to implement large- face at least three overarching issues improvement in student outcomes, scale, system-changing reforms that critical to their success in implementing including making substantial gains in result in improved student achievement, their Race to the Top plans—the need student achievement, closing narrowed achievement gaps, and for a coherent reform agenda, the achievement gaps, improving high increased graduation and college capacity to lead LEAs, and the ability to school graduation rates, and ensuring enrollment rates. improve outcomes. In this notice, these student preparation for success in The ARRA specifies that applications three issues are reflected in the State college and careers; and implementing for Race to the Top funds must address Success Factors as follows: Criterion ambitious plans in four core education the four assurance areas referenced in (A)(1) pertains to a State’s ability to reform areas— section 14006(a)(2): Enhancing articulate a comprehensive and coherent (a) Adopting internationally standards and assessments, improving education reform agenda, and to engage benchmarked standards and the collection and use of data, its local educational agencies (LEAs) in assessments that prepare students for increasing teacher effectiveness and strongly committing to and participating success in college and the workplace; achieving equity in teacher distribution, in that agenda; criterion (A)(2) relates to (b) Building data systems that and turning around struggling schools. a State’s capacity to implement its measure student success and inform The Department published the NPP to proposed plans through strong teachers and principals about how they solicit public comment on the priorities, leadership, successfully supporting its can improve their practices; requirements, and selection criteria that LEAs in improving student outcomes, (c) Increasing teacher and principal State applications will address in administering a grant of this magnitude effectiveness and achieving equity in accordance with this statutory efficiently, and organizing its financial their distribution; and requirement. resources to optimize impact; and (d) Turning around our lowest- The NPP prompted an outpouring of finally, criterion (A)(3) asks States to achieving schools. Additional public comments. Some 1,161 demonstrate their ability to significantly information on the Race to the Top commenters submitted thousands of improve education outcomes for program can be found at: http:// unique comments, ranging from one students across the State. www.ed.gov/programs/racetothetop. paragraph to 67 pages. Parents More specifically, criterion (A)(1)(i) is Program Authority: American submitted comments, as did a new criterion that asks States to set Recovery and Reinvestment Act of 2009, professional associations. From the forth a comprehensive and coherent Division A, Section 14006, Public Law statehouse to the schoolhouse, scores of reform agenda that clearly articulates 111–5. public officials and educators, their goals for implementing reform in
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the four education areas described in States’ capacity to implement their Standards and Assessments the ARRA and improving student plans. Criterion (A)(2)(i)(a) asks States to In response to comments indicating outcomes statewide, establishes a clear demonstrate that they have strong that some States would have difficulty and credible path to achieving these leadership and dedicated teams to meeting a June 2010 deadline for goals, and is consistent with the specific implement their statewide education adopting a new set of common, reform plans that the State has proposed reform plans; and criterion (A)(2)(i)(b) kindergarten-to-grade-12 (K–12) throughout its application. (proposed (E)(5)(ii)) encourages States to standards, this notice extends the Under criterion (A)(1)(ii) (proposed describe the activities they will deadline for adopting standards as far as criterion (E)(3)(iv)), States will undertake in supporting participating possible, while still allowing the demonstrate the participation and LEAs in successfully implementing Department to comply with the commitment of their LEAs. First, as their plans. Criterion (A)(2)(i)(c) statutory requirement to obligate all described in criterion (A)(1)(ii)(a), the (proposed criterion (E)(5)(i)) asks States Race to the Top funds by September 30, strength of LEAs’ commitments to their about the effectiveness and efficiency of 2010. As set forth in criterion (B)(1)(ii), State’s plans will be evaluated based on their operations and processes for the terms and conditions in a State’s the new deadline for adopting a set of implementing a Race to the Top grant. binding agreements with its LEAs. (To common K–12 standards is August 2, Criterion (A)(2)(i)(d) (proposed (E)(5)(v)) support States’ efforts, the Department 2010. States that cannot adopt a has drafted a model Memorandum of further clarifies that States will be common set of K–12 standards by this Understanding (MOU) and included it evaluated based on how they plan to use date will be evaluated based on the in Appendix D of this notice.) Criterion the funds for this grant, as described in extent to which they demonstrate (A)(1)(ii)(b) has been added to make it their budgets and accompanying budget commitment and progress toward clear that the commitment of narratives, to accomplish their plans adoption of such standards by a later participating LEAs will also be judged, and meet their performance targets. date in 2010 (see criterion (B)(1) and in part, based on LEAs’ agreements to Proposed criterion (E)(5)(iv), regarding Appendix B). Evidence supporting the implement all or significant portions of collaboration between States, is not State’s adoption claims will include a the work outlined in the State’s plan. included in this final notice. description of the legal process in the State for adopting standards, and the Criterion (A)(1)(ii)(c) clarifies that the In criterion (A)(2)(ii) (proposed State’s plan, current progress against extent of an LEA’s leadership support (E)(3)(i) and (E)(3)(ii)), States that plan, and timeframe for adoption. for participating in the State’s Race to demonstrate that they have a plan to use the Top plans will be assessed by how For criteria (B)(1) and (B)(2) (proposed the support from a broad group of criteria (A)(1) and (A)(2), respectively), many signatures are on the binding stakeholders to better implement their agreement between the State and the regarding the development and reform plans. Criterion (A)(2)(ii)(a) adoption of common, high-quality LEA, from among (if applicable) the concerns enlisting the support of superintendent, the president of the standards and assessments, the term teachers and principals as key ‘‘significant number of States’’ has been local school board, and the local stakeholders. Criterion (A)(2)(ii)(b) asks teachers’ union leader, or their further explained in the scoring rubric States to describe the strength of that will be used by reviewers to judge equivalents (provided that there is at statements and actions of support from least one authorized LEA signatory on the Race to the Top applications (see other critical stakeholders, and the agreement). For all of these criteria, Appendix B). The rubric clarifies that, examples of these are listed. Proposed States will be asked to provide as on this aspect of the criterion, a State criterion (E)(3)(iii), regarding the evidence examples of their participating will earn ‘‘high’’ points if its consortium LEA agreements as well as tables that support of grant-making foundations includes a majority of the States in the summarize which portions of the State and other funding sources, is not country; it will earn ‘‘medium’’ or plans LEAs are committing to included in this final notice. ‘‘low’’ points if its consortium includes implement and how extensive the LEAs’ Criterion (A)(3) addresses the extent one-half or fewer of the States in the leadership support is. to which the State has demonstrated country. Criterion (A)(1)(iii) (adapted from significant progress in raising Further, for criterion (B)(2), proposed criteria (E)(3)(iv) and (E)(4)) achievement and closing gaps. Criterion concerning the development and asks States to describe how the (A)(3)(i) (proposed criteria (E)(1)(i) and implementation of common, high- engagement of those LEAs that are (E)(1)(ii)) provides for the evaluation of quality assessments, States will be asked participating in the State’s Race to the States based on whether they have made to present, as evidence, copies of their Top plans will translate into broad progress in each of the four education Memoranda of Agreement showing that statewide impact on student outcomes, reform areas over the past several years the State is part of a consortium that including increasing achievement and and used ARRA and other Federal and intends to develop high-quality decreasing achievement gaps for (at a State funding to pursue such reforms. assessments aligned with the minimum) reading/language arts and consortium’s common set of standards. mathematics on the National Criterion (A)(3)(ii) (proposed criterion This is similar to the evidence required Assessment of Educational Progress (E)(1)(iv)) addresses States’ track records for criterion (B)(1) concerning the (NAEP) and on the assessments required of increasing student achievement, development and adoption of common under the Elementary and Secondary decreasing achievement gaps, and standards. Education Act of 1965, as amended increasing graduation rates. When Finally, this notice clarifies the (ESEA); and increasing high school evaluating these student academic language in criterion (B)(3) (proposed graduation rates, college enrollment outcomes, reviewers will examine criterion (A)(3)) regarding the transition rates, and college credit accumulation. student assessment results in reading/ to enhanced standards and high-quality Criterion (A)(2) asks States to describe language arts and mathematics, both on assessments; the criterion now lists a their capacity to implement, scale up, the NAEP and on the assessments number of activities in which States or and sustain their proposed plans. required under the ESEA; progress will LEAs might engage as they work to Criterion (A)(2)(i) (adapted from be considered for each subgroup as well translate the standards and assessments proposed criterion (E)(5)) concerns as for the ‘‘all students’’ group. into classroom practice.
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Data Systems to Support Instruction development of outstanding models for categories, and should be designed and The data systems selection criteria in teacher and principal evaluation developed with teacher and principal the Race to the Top competition involve systems, now widely described as involvement. Criterion (D)(2)(iii) two types of data systems—statewide flawed and superficial. Based on this (proposed criteria (C)(2)(c) and longitudinal data systems and and similar comments, the Department (C)(2)(d)(i)) encourages such evaluations instructional improvement systems. has revised criterion (D)(2), now titled to be conducted annually and to include While numerous comments addressed Improving Teacher and Principal timely and constructive feedback, while Effectiveness Based on Performance, to criterion (D)(2)(iv) (proposed criterion the Department’s emphasis on statewide encourage the design of high-quality (C)(2)(d)) addresses uses of evaluations longitudinal data systems in the NPP, evaluation systems, and to promote to inform decision-making. the Department intends to give equal their use for feedback, professional Criteria (D)(2)(iv)(c) and (D)(2)(iv)(d) priority in this program to using improvement, and decision-making. (proposed criterion (C)(2)(d)(iii)) instructional data as a critical tool for The Department concurs with the separately address the use of these teachers, principals, and administrators many commenters who cautioned that evaluation systems to inform decisions to identify student needs, fill teacher and principal ‘‘effectiveness’’ regarding whether to grant tenure and/ curriculum gaps, and target professional should not be based solely on student or full certification to effective teachers development. The final selection test scores. In this notice, and principals (in criterion (D)(2)(iv)(c)), criteria, therefore, place significant ‘‘effectiveness’’ is defined as based on and removing ineffective teachers and emphasis on using data to inform input from multiple measures, provided principals (in criterion (D)(2)(iv)(d)). In professional development and fostering that student growth is a significant addition, the Department has clarified a culture of continuous improvement in factor. In addition, this notice re- that these decisions should be made schools and LEAs. emphasizes that it is student growth— using rigorous standards and More specifically, the final notice not raw student achievement data or streamlined, transparent, and fair contains new language in criterion proficiency levels—that is the procedures. (C)(3)(i) (proposed (B)(3)(i)) that clarifies ‘‘significant factor’’ to be considered in Criterion (D)(3) (proposed (C)(3)) has that this criterion concerns local evaluating effectiveness. been revised to clarify that the State’s instructional improvement systems, not Finally, this notice expands and plan for the equitable distribution of statewide longitudinal data systems, improves the four selection criteria that effective teachers and principals should and further clarifies the LEA’s role in deal with teacher and principal be informed by the State’s prior actions the acquisition, adoption, and use of professional development (criteria and data, and should ensure that local instructional improvement (B)(3), (C)(3)(ii), (D)(2)(iv)(a), and (D)(5)). students in high-poverty as well as high- systems. It clarifies that professional minority schools have equitable access New criterion (C)(3)(ii) was added to collaboration and planning time, to highly effective teachers and encourage LEAs and States to provide individualized professional principals—and are not served by effective professional development on development plans, training and ineffective ones at higher rates than are using data from these systems to support in the analysis and use of data, other students. The performance support continuous instructional classroom observations with immediate measures for this criterion now include, improvement. feedback, and other activities are critical for comparison purposes, data on the Great Teachers and Leaders to supporting the development of presence of highly effective and teachers and principals. ineffective teachers and principals in The teachers and leaders criteria are Specifically, criterion (D)(1) low-poverty and low-minority schools. built on two core principles that remain (proposed (C)(1)), concerning high- Criterion (D)(4) concerns improving consistent with the NPP—that teacher quality pathways for aspiring teachers the effectiveness of teacher and and principal quality matters, and that and leaders, has been expanded. It now principal preparation programs. effective teachers and principals are includes a new criterion (D)(1)(iii), Criterion (D)(4)(i) (proposed (C)(4)) was those whose students grow under which States will be evaluated revised to specify that, when reporting academically. Thus, this notice based on the extent to which they have the effectiveness of teacher and continues to include criteria directed at in place a process for monitoring, principal credentialing programs, States improving teacher and principal evaluating, and identifying areas of should report student growth as well as effectiveness and at ensuring that highly teacher and principal shortage and for student achievement data; they should effective teachers and principals are preparing teachers and principals to fill report the data for all in-State serving in the high-poverty, high- these areas of shortage. credentialing programs, regardless of the minority schools where their talents are Criterion (D)(2) (proposed (C)(2)) has number of graduates; and they should needed the most. In addition, this notice been revised to focus on the design and publicly report data, not ‘‘findings.’’ continues to define effective teachers use of rigorous, transparent, and fair Criterion (D)(4)(ii) has been added to and principals as those whose students evaluation systems that provide regular encourage States to expand those make significant academic growth. feedback on performance to teachers preparation and credentialing options While the final notice reaffirms these and principals. This criterion also has and programs that are successful at core principles, it also includes a been changed to clarify that the LEAs, producing effective teachers and number of changes to the criteria and not the States, should implement the principals (both as defined in this related definitions based on public teacher and principal effectiveness notice). input. reforms under this criterion, and that Criterion (D)(5) (proposed criterion The Department received over 400 the role of the States is to support their (C)(5)) focuses on providing effective comments in this reform area, many of participating LEAs in implementing support to teachers and principals. which provided helpful suggestions that these reforms. Here, the Department has inserted a new informed our revisions. One commenter Criterion (D)(2)(ii) (proposed (C)(2)(b)) paragraph, (D)(5)(i), to provide suggested that the greatest contribution now emphasizes that these evaluation additional guidance on, and examples that the Race to the Top program could systems should differentiate of, effective support. The Department make would be to encourage the effectiveness using multiple rating has also removed the reference to using
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‘‘rapid-time’’ student data to inform and Specifically, the following changes accountability. In support of charter guide the supports provided to teachers have been made to criterion (E)(2) school growth, the criteria also provide and principals. (proposed criterion (D)(3)), regarding for the evaluation of States based on the turning around the lowest-achieving extent to which they provide equitable Turning Around the Lowest-Achieving schools. Criterion (E)(2)(i) (proposed funding for charter schools and offer Schools (D)(3)(i)) has been changed to allow them access to facilities. Criterion The Department made three States, at their discretion, to use Race to (F)(2)(ii) has also been revised to urge noteworthy changes to the selection the Top funds to turn around non-Title authorizers to encourage charter schools criteria on turning around the I eligible secondary schools that would that serve student populations that are persistently lowest-achieving schools. be considered ‘‘persistently lowest- similar to local district student First, this notice removes the restriction, achieving schools’’ if they were eligible populations, especially relative to high- proposed in the NPP, that permitted the to receive Title I funds. need students. ‘‘transformation’’ model to be used Criterion (E)(2)(ii) (proposed criterion In their comments, a number of States solely as a last resort. Instead, we (D)(3)(ii)) has been changed by removing argued that they had laws—other than simply specify that an LEA with more the clause that restricted the use of the charter school laws—that spurred than nine persistently lowest-achieving ‘‘transformation’’ model to situations school innovation. In response to these schools may not use the transformation where the other intervention models comments, the Department has added a model for more than 50 percent of its were not possible and by specifying that new criterion, (F)(2)(v), that invites schools. an LEA with more than nine States to describe the extent to which Second, the Department has fully persistently lowest-achieving schools they enable LEAs to operate innovative, aligned the school intervention may not use the transformation model autonomous public schools other than requirements and definitions across for more than 50 percent of its schools. charter schools. It is the Department’s hope that the Race to the Top, the State Fiscal In addition, the four intervention Race to the Top competition gives States Stabilization Fund, and the forthcoming models LEAs may use under this ample opportunity to explain and Title I School Improvement Grants final criterion are now described in detail in implement proven and promising ideas notice. The Department’s intention, in Appendix C, and these models have for bolstering student learning and so doing, is to make it easier for States been made identical across the Race to educational attainment, and to do this to develop consistent and coherent the Top, State Fiscal Stabilization Fund, in ways that work best in their local plans across these three programs. and Title I School Improvement Grants notices. contexts. To ensure that the application Third, the public comments suggested Finally, the evidence collected for reflects a broad range of effective State that there was confusion about the role criterion (E)(2) will include the State’s and local solutions, criterion (F)(3) of charter schools in the Department’s historic performance on school (proposed criterion (E)(1)(iii)) asks reform agenda. Some commenters turnaround efforts, as evidenced by the States to describe laws, regulations, or concluded that by placing the charter total number of persistently lowest- policies (other than those asked about in school criterion in the school achieving schools that States or LEAs other selection criteria) that have turnaround section, the Department was attempted to turn around in the last five created conditions in the State that are advancing charter schools as the chief years, the approach used, and the conducive to education reform and remedy for addressing the needs of the results and lessons learned to date. improved student outcomes. persistently lowest-achieving schools. While the Department believes that General Priorities charter schools can be strong partners in The General section includes a Many commenters offered suggestions school turnaround work, it does not number of other key reform conditions about the proposed priorities, in believe that charter schools are the only or plans. particular the invitational and or preferred solution to turning around First, criterion (F)(1) concerns competitive preference priorities. A struggling schools. In fact, it is the education funding across the State. number of commenters urged the Department’s belief that turning around Criterion (F)(1)(i) (proposed (E)(2)) Department to increase the importance the persistently lowest-achieving addresses the State’s efforts to maintain of each invitational priority by making schools is a core competency that every education funding between FY 2008 and it a competitive or absolute priority, district needs to develop, and that FY 2009. New criterion (F)(1)(ii) has while others wanted to add new closing bad schools and opening good been added to reward States whose priorities. Because of the Department’s ones is the job of school district leaders. policies lead to equitable funding desire to give States latitude and Notwithstanding research showing that between high-need LEAs and other flexibility in developing focused plans charter schools on average perform LEAs, and within LEAs, between high- to best meet their students’ needs, we similarly to traditional public schools, a poverty schools and other schools. are not changing any of the priorities growing body of evidence suggests that As noted above, criterion (F)(2) from invitational to competitive or high-quality charter schools can be regarding charter schools has been absolute. We did, however, add a new powerful forces for increasing student moved to the General section from the invitational priority and make some achievement, closing achievement gaps, Turning Around the Lowest-Achieving changes to the proposed priorities. and spurring educational innovation. As Schools section, where it was proposed Regarding the proposed absolute a consequence, the selection criterion criterion (D)(2). In this notice, the priority, which stated that States’ pertaining to charter schools (criterion Department maintains its focus on high- applications must comprehensively and (F)(2), proposed (D)(2)) has been shifted quality charter schools as important coherently address all of the four from the Turning Around the Lowest- tools for school reform. education reform areas specified in the Achieving Schools section to the As was the case with the NPP, the ARRA, the Department has added the General section, where it more final charter school criteria presented requirement that States must appropriately reflects charter schools’ under (F)(2) encourage both comprehensively and coherently broader role as a tool for school unrestrictive charter school growth laws address the new State Success Factors innovation and reform. and strong charter school criteria as well.
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The final notice adds a new Application requirement (c)(2) The definition of formative invitational priority 3, Innovations for provides additional clarity about how to assessment has been revised to clarify Improving Early Learning Outcomes, calculate the relative shares of the Race that formative assessments are expressing the Secretary’s interest in to the Top grant that participating LEAs assessment questions, tools and applications that will improve early will be eligible to receive. processes and to require that feedback learning outcomes for high-need The Department has added a new from such assessments need only be students who are young children. application requirement, requirement timely rather than instant. In invitational priority 4 (proposed (g), to clarify specific issues related to Under a new definition of high- priority 3), Expansion and Adaptation of the term ‘‘subgroup,’’ to NAEP, and to minority school, States are to define Statewide Longitudinal Data Systems, the assessments required under the high-minority schools in their programs such as at-risk and dropout ESEA. In addition to requiring States to applications in a manner consistent prevention programs, school climate include, at a minimum, the listed with their Teacher Equity Plans. and culture programs, and early student subgroups when reporting past The definition of high-need LEA was learning programs have been added to outcomes and setting future targets, this changed to conform with the definition the list of programs that a State may application requirement includes of this term used in section 14013 of the choose to integrate with its statewide statutory references. This addition ARRA. longitudinal data system. eliminates the need for statutory The final notice adds and defines In invitational priority 5 (proposed references that define subgroups high-need students to mean students at priority 4), P–20 Coordination, Vertical elsewhere in the notice, and they risk of educational failure or otherwise and Horizontal Alignment, horizontal therefore have been removed. in need of special assistance and coordination of services was added as a The program requirements have also support, such as students who are living changed. First, the Department has critical component for supporting high- in poverty, who attend high-minority indicated its final approach to need students. schools (as defined in this notice), who evaluation. The Institute of Education In invitational priority 6 (proposed are far below grade level, who have left Sciences will conduct a series of priority 5), School-level Conditions for school before receiving a regular high national evaluations of Race to the Top Reform, Innovation, and Learning, new school diploma, who are at risk of not State grantees as part of its evaluation of paragraph (vi) adds school climate and graduating with a diploma on time, who programs funded under the ARRA. culture, and new paragraph (vii) adds are homeless, who are in foster care, States that are awarded Race to the Top family and community engagement to who have been incarcerated, who have grants will be required to participate in the list of school conditions conducive disabilities, or who are English language these evaluations and are welcome, but 1 to reform and innovation. learners. not required, to conduct their own The final notice adds a definition of Requirements independent, statewide evaluations as high-performing charter school. This well. The first eligibility requirement, definition refers to a charter school that Finally, the program requirements requirement (a), has been changed to has been in operation for at least three have clarified that funds awarded under provide that a State must have both consecutive years and has demonstrated this competition may not be used to pay phases of its State Fiscal Stabilization overall success, including substantial for costs related to statewide summative Fund application approved by the progress in improving student assessments. Department prior to being awarded a achievement and having the Race to the Top grant. In the NPP, we Definitions management and leadership necessary to overcome initial start-up problems proposed that a State would have to The Department has revised the and establish a thriving, financially receive approval of its Stabilization definition of alternative routes to viable charter school. Fund applications prior to December 31, certification to require that in addition The definition of high-quality 2009 (for Race to the Top Phase 1 to the other program characteristics assessment has been revised to clarify applicants) or prior to submitting a Race listed, the program must be selective in that test design must, to the extent to the Top application (for Race to the accepting candidates. The revised feasible, use universal design principles Top Phase 2 applicants). definition also clarifies that such in development and administration, and The second eligibility requirement, programs should include standard incorporate technology where requirement (b), was revised to clarify features of high-quality preparation appropriate. that the State must not have any legal, programs and award the same level of The final notice also adds a definition statutory, or regulatory barriers at the certification that is awarded by of increased learning time, which refers State level to linking data on student traditional preparation programs. achievement (as defined in this notice) A new definition of college to using a longer school day, week, or or student growth (as defined in this enrollment refers to the enrollment of year schedule to significantly increase notice) to teachers and principals for the students who graduate from high school the total number of school hours to purpose of teacher and principal consistent with 34 CFR 200.19(b)(1) and include additional time for (a) evaluation. who enroll in an institution of higher instruction in core academic subjects, In addition, several changes were education (as defined in section 101 of including English; reading or language made to the application requirements. the Higher Education Act, Public Law arts; mathematics; science; foreign The Department removed two proposed 105–244, 20 U.S.C. 1001) within 16 languages; civics and government; application requirements, application months of graduation. economics; arts; history; and geography; requirements (c) and (d), which would The final notice revises the (b) instruction in other subjects and have required States to provide definitions of effective teacher, effective enrichment activities that contribute to information about making education principal, highly effective teacher, and a well-rounded education, including, for funding a priority and about stakeholder highly effective principal to require that 1 The term English language learner, as used in support. Note that the final notice multiple measures be used to evaluate this notice, is synonymous with the term limited retains the selection criteria that request effectiveness, and provides several English proficient, as defined in section 9101 of the this same information. examples of appropriate measures. ESEA.
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example, physical education, service LEA that does not receive funding under General Comments on the Race to the learning, and experiential and work- Title I, Part A (as well as one that does) Top Program based learning opportunities that are may receive funding from the State’s Reorganization of the Final Notice provided by partnering, as appropriate, other 50 percent of the grant award, in with other organizations; and (c) accordance with the State’s plan. Comment: None. teachers to collaborate, plan, and engage Discussion: The selection criteria in The term persistently lowest- in professional development within and this notice are reordered. The most across grades and subjects. performing schools has been changed to significant change is the addition of The final notice adds a definition of persistently lowest-achieving schools. State Success Factors to the beginning of innovative, autonomous public schools The definition has been revised to the selection criteria. State Success to refer to open enrollment public include the lowest-achieving five Factors criteria include some new schools that, in return for increased percent criterion originally included in criteria, as well as criteria that are accountability for student achievement proposed criterion (D)(3) and to add adapted from proposed criteria from the (as defined in this notice), have the high schools with graduation rates overall selection criteria section flexibility and authority to define their below 60 percent. The definition also proposed in the NPP. This instructional models and associated provides that, in determining the reorganization will give States the curriculum; select and replace staff; lowest-achieving schools, a State must opportunity to begin their proposals implement new structures and formats consider the academic achievement of with clear statements of their coherent for the school day or year; and control the ‘‘all students’’ group for each school and coordinated statewide reform their budgets. in terms of proficiency on the State’s agendas. However, with this change, it was necessary to redesignate the In the definition of instructional assessments required by the ESEA in remaining criteria. For example, in the improvement systems, the Department reading/language arts and mathematics now provides examples of related types NPP, the criteria related to standards combined, and the lack of progress by of data that could be integrated into and assessments were designated as ‘‘A’’ that group on these assessments over a these systems. (e.g., (A)(1), (A)(2), etc.), but in this final The final notice adds a definition of number of years. notice have been re-designated as ‘‘B’’ involved LEAs, which refers to LEAs The definition of rapid-time, in (e.g., (B)(1), (B)(2), etc.). One way to that choose to work with the State to reference to reporting and availability of indicate this change throughout the implement those specific portions of the data, has been changed to remove the final notice is to include both references State’s plan that necessitate full or specification of a turnaround time of 72 every time a criterion is used (e.g., nearly full statewide implementation, hours and to clarify that it refers to revised criterion (B)(1) (proposed such as transitioning to a common set of locally collected school- and LEA-level criterion (A)(1)). Given the length of this K–12 standards, (as defined in this data. notice and the extensive references to notice). Involved LEAs do not receive a criteria, we have opted to refer only to share of the 50 percent of a State’s grant The definition of student achievement the revised designation in the award that it must subgrant to LEAs in has been revised to include several discussion of the comments. For accordance with section 14006(c) of the examples of alternate measures of example, we refer to a criterion for ARRA; however, States may provide student learning and performance for standards and assessments as ‘‘criterion other funding to involved LEAs under non-tested grades and subjects. The (B)(1),’’ rather than as ‘‘revised criterion the State’s Race to the Top grant in a final notice also clarifies that, for tested (B)(1) (proposed criterion (A)(1)).’’ In a manner that is consistent with the grades and subjects, student few instances, we refer to ‘‘proposed State’s application. achievement can be measured using criterion’’ or ‘‘revised criterion’’ for The final notice adds a definition of alternative measures of student learning clarity but, generally, do not refer to low-minority school, which is to be and performance in addition to the each criterion with both its ‘‘revised’’ defined by the State in a manner State’s assessments under the ESEA. and ‘‘proposed’’ designation. We believe consistent with the State’s Teacher Finally, the reference to Individualized this format makes the document easier Equity Plan. Education Program (IEP) goals as a to read and understand. As a reminder A new definition of low-poverty potential achievement measure has been to readers, we include both the final and school refers, consistent with section removed. proposed designations under the 1111(h)(1)(C)(viii) of the ESEA, to a appropriate headings. Table 1 lists the school in the lowest quartile of schools The definition of student growth was final criteria and the corresponding in the State with respect to poverty clarified to mean the change in student proposed criteria. In Table 2, the level, using a measure of poverty achievement (as defined in this notice) columns are reversed to show the determined by the State. for an individual student between two proposed criteria and the corresponding The final notice adds a definition of or more points in time, rather than just final criteria. participating LEAs, which refers to between two points in time, as the NPP There is a similar re-designation of LEAs that choose to work with the State had proposed, and that a State may also the priorities. Specifically, we added a to implement all or significant portions include other measures that are rigorous new invitational priority on innovations of the State’s Race to the Top plan, as and comparable across classrooms. for improving early learning outcomes specified in each LEA’s agreement with In the following section, the and designated it as priority 3. the State. Each participating LEA that Department has summarized and Subsequent priorities were re- receives funding under Title I, Part A numbered, and thus, proposed priorities provided its responses to the comments will receive a share of the 50 percent of 3, 4, and 5 are now priorities 4, 5, and received. a State’s grant award that the State must 6, respectively. As with the selection subgrant to LEAs, based on the LEA’s Analysis of Comments and Changes: criteria, generally, we will refer only to relative share of Title I, Part A An analysis of the comments and of any the final designation for these priorities allocations in the most recent year (that changes in the priorities, requirements, and will use headers, as appropriate, to is, 2009), in accordance with section definitions, and selection criteria since remind the reader of the changes. Thus, 14006(c) of the ARRA. Any participating publication of the NPP follows. for example, we will refer to the priority
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on Expansion and Adaptation of Changes: We have re-designated the to proposed designations for clarity. Statewide Longitudinal Data Systems, selection criteria and proposed Three tables have been added to show which was proposed priority 3 in the priorities 3, 4, and 5. We will refer to how the final selection criteria and NPP, as priority 4. Table 3 summarizes the selection criteria and priorities with priorities relate to the proposed criteria these changes. their final designations throughout this and priorities. notice and, in a few instances, will refer
TABLE 1—THE FINAL SELECTION CRITERIA COMPARED WITH THE PROPOSED SELECTION CRITERIA
Final notice Proposed notice
A. State Success Factors (E)(1), (E)(3), (E)(4), (E)(5), and new A1. Articulating State’s education reform agenda and LEAs’ partici- (E)(3)(iv), new pation in it (A)(1)(i) New (A)(1)(ii) (E)(3)(iv) (A)(1)(ii)(a) (E)(3)(iv) (A)(1)(ii)(b) (E)(3)(iv) (A)(1)(ii)(c) (E)(3)(iv) (A)(1)(iii)(a) (E)(3)(iv) and (E)(4)(i) (A)(1)(iii)(b) (E)(3)(iv) and (E)(4)(ii) (A)(1)(iii)(c) (E)(3)(iv) and (E)(4)(iii) (A)(1)(iii)(d) (E)(3)(iv) and new A2. Building strong statewide capacity to implement, scale up, and (E)(3)(i–ii), (E)(5), and new sustain proposed plans (A)(2)(i)(a) New (A)(2)(i)(b) (E)(5)(ii) (A)(2)(i)(c) (E)(5)(i) (A)(2)(i)(d) (E)(5)(v) (A)(2)(i)(e) (E)(5)(iii) (A)(2)(ii)(a) (E)(3)(i) (A)(2)(ii)(b) (E)(3)(i–ii) A3. Demonstrating significant progress in raising achievement and (E)(1) and (E)(4) closing gaps (A)(3)(i) (E)(1)(i–ii) (A)(3)(ii)(a) (E)(1)(iv) (A)(3)(ii)(b) (E)(1)(iv) (A)(3)(ii)(c) (E)(1)(iv) B. Standards and Assessments A. Standards and Assessments B1. Developing and adopting common standards (A)(1) (B)(1)(i)(a) (A)(1)(i) and (A)(1)(ii) (B)(1)(i)(b) (A)(1)(i) and (A)(1)(ii) (B)(1)(i)(c) (A)(1)(i) and (A)(1)(ii) (B)(1)(ii)(a) (A)(1)(i) (B)(1)(ii)(b) (A)(1)(ii) B2. Developing and implementing common, high-quality assess- (A)(2) ments (B)(2)(a) (A)(2) (B)(2)(a) (A)(2) B3. Supporting the transition to enhanced standards and high- (A)(3) quality assessments C. Data Systems to Support Instruction B. Data Systems to Support Instruction C1. Fully implementing a statewide longitudinal data system (B)(1) C2. Accessing and using State data (B)(2) C3. Using data to improve instruction (B)(3) (C)(3)(i) (B)(3)(i) (C)(3)(ii) New (C)(3)(iii) (B)(3)(ii) D. Great Teachers and Leaders C. Great Teachers and Leaders D1. Providing high-quality pathways for aspiring teachers and prin- (C)(1) cipals (D)(1)(i) (C)(1) (D)(1)(ii) (C)(1) (D)(1)(iii) New D2. Improving teacher and principal effectiveness based on per- (C)(2) formance (D)(2)(i) (C)(2)(a) (D)(2)(ii) (C)(2)(b) (D)(2)(iii) (C)(2)(c) and (C)(2)(d)(i) (D)(2)(iv) (C)(2)(d) (D)(2)(iv)(a) (C)(2)(d)(i) (D)(2)(iv)(b) (C)(2)(d)(ii) (D)(2)(iv)(c) (C)(2)(d)(iii) (D)(2)(iv)(d) (C)(2)(d)(iii) D3. Ensuring equitable distribution of effective teachers and prin- (C)(3) cipals
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TABLE 1—THE FINAL SELECTION CRITERIA COMPARED WITH THE PROPOSED SELECTION CRITERIA—Continued
Final notice Proposed notice
(D)(3)(i) (C)(3) (D)(3)(ii) (C)(3) D4. Improving the effectiveness of teacher and principal prepara- (C)(4) tion programs (D)(4)(i) (C)(4) (D)(4)(ii) New D5. Providing effective support to teachers and principals (C)(5) (D)(5)(i) (C)(5) (D)(5)(ii) (C)(5) E. Turning Around the Lowest-Achieving Schools D. Turning Around Struggling Schools E1. Intervening in the lowest-achieving schools and LEAs (D)(1) E2. Turning around the lowest-achieving schools (D)(3) (E)(2)(i) (D)(3)(i) (E)(2)(ii) (D)(3)(ii) F. General Selection Criteria (D)(2), (E)(1), (E)(2), and new F1. Making education funding a priority (E)(2) and new (F)(1)(i) (E)(2) (F)(1)(ii) New F2. Ensuring successful conditions for high-performing charter (D)(2) schools and other innovative schools (F)(2)(i) (D)(2)(i) (F)(2)(ii) (D)(2)(ii) (F)(2)(iii) (D)(2)(iii) (F)(2)(iv) (D)(2)(iv) (F)(2)(v) New F3. Demonstrating other significant reform conditions (E)(1)(iii) Removed (E)(3)(iii) Removed (E)(5)(iv)
TABLE 2—THE PROPOSED SELECTION CRITERIA COMPARED WITH THE FINAL SELECTION CRITERIA
Proposed notice Final notice
A. Standards and Assessments B. Standards and Assessments (A)(1). Developing and adopting common standards (B)(1) (A)(1)(i) (B)(1)(i), (B)(1)(ii)(a) (A)(1)(ii) (B)(1)(i), (B)(1)(ii)(b) (A)(2). Developing and implementing common, high-quality assess- (B)(2) ments (A)(3). Supporting the transition to enhanced standards and high- (B)(3) quality assessments B. Data Systems to Support Instruction C. Data Systems to Support Instruction (B)(1). Fully implementing a statewide longitudinal data system (C)(1) (B)(2). Accessing and using State data (C)(2) (B)(3). Using data to improve instruction (C)(3)(i), (C)(3)(iii) (B)(3)(i) (C)(3)(i) (B)(3)(ii) (C)(3)(iii) C. Great Teachers and Leaders D. Great Teachers and Leaders (C)(1). Providing high-quality pathways for aspiring teachers and (D)(1)(i–ii) principals (C)(2). Improving teacher and principal effectiveness based on per- (D)(2) formance (C)(2)(a) (D)(2)(i) (C)(2)(b) (D)(2)(ii) (C)(2)(c) (D)(2)(iii) (C)(2)(d)(i) (D)(2)(iii), (D)(2)(iv)(a) (C)(2)(d)(ii) (D)(2)(iv)(b) (C)(2)(d)(iii) (D)(2)(iv)(c), (D)(2)(iv)(d) (C)(3). Ensuring equitable distribution of effective teachers and (D)(3)(i), (D)(3)(ii) principals (C)(4). Reporting the effectiveness of teacher and principal prepa- (D)(4)(i) ration programs (C)(5). Providing effective support to teachers and principals (D)(5)(i), (D)(5)(ii) D. Turning Around Struggling Schools E. Turning Around the Lowest-Achieving Schools (D)(1). Intervening in the lowest-achieving schools and LEAs (E)(1) (D)(2). Increasing the supply of high-quality charter schools (F)(2) (D)(2)(i) (F)(2)(i) (D)(2)(ii) (F)(2)(ii) (D)(2)(iii) (F)(2)(iii) (D)(2)(iv) (F)(2)(iv) (D)(3). Turning around the lowest-achieving schools (E)(2)
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TABLE 2—THE PROPOSED SELECTION CRITERIA COMPARED WITH THE FINAL SELECTION CRITERIA—Continued
Proposed notice Final notice
(D)(3)(i) (E)(2)(i) (D)(3)(ii) (E)(2)(ii) E. Overall Selection Criteria (A) State Success Factors and (F) General Selection Criteria (E)(1). Demonstrating significant progress (A)(3)(i), (A)(3)(ii), (F)(3) (E)(1)(i) (A)(3)(i) (E)(1)(ii) (A)(3)(i) (E)(1)(iii) (F)(3) (E)(1)(iv) (A)(3)(ii) (E)(2). Making education funding a priority (F)(1)(i) (E)(3). Enlisting statewide support and commitment (A)(1)(ii), (A)(1)(iii), (A)(2)(ii) (E)(3)(i) (A)(2)(ii)(a), (A)(2)(ii)(b) (E)(3)(ii) (A)(2)(ii)(b) (E)(3)(iii) Removed (E)(3)(iv) (A)(1)(ii), (A)(1)(iii) (E)(4). Raising achievement and closing gaps (A)(1)(iii) (E)(4)(i) (A)(1)(iii)(a) (E)(4)(ii) (A)(1)(iii)(b) (E)(4)(iii) (A)(1)(iii)(c) (E)(5). Building strong statewide capacity to implement, scale up, (A)(2)(i)(b–e) and sustain proposed plans (E)(5)(i) (A)(2)(i)(c) (E)(5)(ii) (A)(2)(i)(b) (E)(5)(iii) (A)(2)(i)(e) (E)(5)(iv) Removed (E)(5)(v) (A)(2)(i)(d) New (A)(1)(i) New (A)(1)(iii)(d) New (A)(2)(i)(a) New (C)(3)(ii) New (D)(1)(iii) New (D)(4)(ii) New (F)(1)(ii) New (F)(2)(v)
TABLE 3—THE FINAL PRIORITIES COMPARED WITH THE PROPOSED PRIORITIES
Final priorities Proposed priorities
Priority 1: Absolute Priority—Comprehensive Approach to Education Priority 1: Absolute Priority. Reform. Priority 2: Competitive Preference Priority—Emphasis on Science, Priority 2: Competitive Preference Priority. Technology, Engineering, and Mathematics (STEM). Priority 3: Invitational Priority—Innovations for Improving Early Learning New. Outcomes. Priority 4: Invitational Priority—Expansion and Adaptation of Statewide Priority 3. Longitudinal Data Systems. Priority 5: Invitational Priority—P–20 Coordination, Vertical and Hori- Priority 4. zontal Alignment. Priority 6: Invitational Priority—School-Level Conditions for Reform, In- Priority 5. novation, and Learning. Priority 6, Paragraph vi. New. Priority 6, Paragraph vii. New.
Overall Comments on the Race to the and be more responsive to the principal effectiveness and turning Top Program commenters. around our lowest-achieving schools. Comment: We received a number of Changes: None. Other commenters expressed their comments that addressed issues related Comment: Many commenters overall opposition to the Race to the to the Race to the Top program in supported our proposals in the NPP and Top program because of what they general, as well as comments that our effort to leverage cutting-edge described as its ‘‘one-size-fits-all’’ focused on a number of priorities and education reforms and innovation in a approach to education reform involving selection criteria. competitive Race to the Top program ‘‘a top-down, narrow definition of Discussion: We are addressing, in this that will lay the foundation for innovation that has little research to section, general comments on the Race significant improvement of America’s support it.’’ Another commenter stated to the Top program, as well as education system. In particular, these that the Department is prescribing a comments that focused on multiple commenters praised the Department’s national formula for education reform, priorities and selection criteria. This proposals for ‘‘game-changing’’ reforms which threatens to undermine the allows us to group similar comments in the areas of improving teacher and program. In particular, several
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commenters objected to the proposed program. We, therefore, believe it would around struggling schools. Moreover, use of test scores as an accurate measure be inconsistent to award a Race to the because the effects of the Race to the of student achievement and what they Top grant, which requires a Top program might not be captured by claimed were ‘‘unproven’’ interventions determination that a State has made existing State accountability systems, such as charter schools and linking significant progress in the four such as those created under the ESEA, teacher compensation to student education reform areas, to a State that this final notice retains the separate achievement data. Many commenters has not met requirements for receiving performance measures included in the asserted that the proposed program funds under the Stabilization program. NPP. design would interfere with State and With regard to the second eligibility In response to commenters’ concerns local prerogatives and responsibilities requirement, we believe that the pertaining to ‘‘unproven’’ interventions for public education. Other commenters capability to link student achievement in the Race to the Top program, there is noted that some of the interventions to teachers and principals for the ample evidence, for example, that high- proposed in Race to the Top, such as purposes of evaluation is fundamental performing charter schools can increasing the number of high-quality to the Race to the Top reforms and to significantly improve the achievement charter schools, are not consistent with the requirement in section 14005(d)(2) of high-need students. Likewise, the existing State laws and might not work of the ARRA that States take actions to research supports that effective teachers as well in rural areas as in urban improve teacher effectiveness. and principals are essential to environments. One commenter stated Furthermore, without the legal authority improving student achievement; that the NPP ignored the existing ESEA to use student achievement or student accordingly, the Department believes school improvement process and growth data for teacher and principal that identifying, recruiting, developing, ‘‘would simply layer another top-down evaluations, States would not be able to and retaining effective teachers and accountability process on top of the execute reform plans related to several school leaders is critical to creating current faulty one.’’ Some of these selection criteria in this notice. high-performing schools and a world- commenters urged that the final notice In addition, the proposed selection class education system. Finally, we are instead encourage States to propose criteria were not designated as providing States with flexibility to multiple innovative, research-based eligibility requirements; instead, they incorporate these reforms into their reform strategies and models tailored to were proposed as recommended plans through their own innovative and their own unique local needs. elements of a comprehensive State plan thoughtful approaches that are designed Discussion: The Department that would provide an individual State to address their specific needs. In appreciates the expressions of support with the flexibility to emphasize its own addition, we are including in this final for its Race to the Top proposal as well priorities and craft a winning notice two additional criteria intended as commenters’ constructive application. This flexible approach has to make this flexibility for innovation suggestions. The Race to the Top been retained in this final notice. For more explicit. program provides a flexible framework instance, States need not address every Changes: We have added the for comprehensive State and local selection criterion, so long as they following criteria: First, criterion innovation in the key reform areas comprehensively and coherently (F)(2)(v) asks a State to demonstrate the identified in the ARRA. In fact, one of address all of the four education reform extent to which it enables LEAs to the key purposes of this program is to areas as well as the State Success operate innovative, autonomous public ask States for their best ideas about how Factors Criteria. schools other than charter schools. to address the levers of change—the four Through this program, the Second, criterion (F)(3) (proposed assurances in the ARRA—to Department will reward success in at criterion (E)(1)(iii)) encourages States to significantly improve student outcomes least two ways: First, by giving States describe any other conditions favorable and advance the field of education credit for having already put into place to education reform or innovation that reform. key conditions for reform, improving have increased student achievement or To create ‘‘room’’ for States to meet student achievement, and closing graduation rates, narrowed achievement this goal, this final notice, consistent achievement gaps; and second, by gaps, or resulted in other important with the NPP, includes only one encouraging States to build on their outcomes. absolute priority and two eligibility assets and successes. We believe that requirements—none of which interferes State plans that build on a foundation Transparency with a State’s flexibility to put forward of successful existing practices will be Comment: Some commenters its best ideas and practices for reform. more likely to succeed in improving requested that the Department make all The absolute priority focuses on student outcomes. State applications and annual reports comprehensiveness and coherence It is important to note that the Race publicly available for review. across the reform areas, and the to the Top program is a voluntary Additional commenters requested that eligibility requirements include (1) competitive grant program. Consistent applications and all related materials be approved applications for funding with section 14006(b) of the ARRA, we posted online prior to approval. under Phase 1 and Phase 2 of the may use ‘‘such other criteria as the Discussion: To foster transparency Stabilization program, and (2) no legal, Secretary determines appropriate’’ in and openness, the Department plans to statutory, or regulatory barriers at the making Race to the Top awards; our post all State applications—for both State level to linking data on student intention is not to fund every State but successful and unsuccessful achievement or student growth to to identify and reward the subset of applications—on our Web site at the teachers and principals for the purpose States that demonstrate the greatest conclusion of each phase of the of teacher and principal evaluation. As promise of making meaningful gains in competition, together with the final we noted in the NPP, section 14005(d) developing standards and assessments, scores each received. States may choose of the ARRA requires a State that using data to drive improved student to make their applications publicly receives funds under the Stabilization outcomes, improving teacher and available at any time. We also anticipate program to provide assurances in the principal effectiveness and achieving making State annual reports publicly same four education reform areas that equity in the distribution of effective available. are advanced by the Race to the Top teachers and principals, and turning Changes: None.
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Allocation of Points Discussion: The scoring rubric assigns States are required to give priority to Comment: Several commenters more weight to accomplishments (i.e., high-need LEAs in their Race to the Top requested clarification concerning the State Reform Conditions Criteria) than plans; and strategies to improve school weighting of selection criteria. Two to plans (i.e., Reform Plan Criteria). (See climate, develop partnerships with commenters specifically requested that Appendix B). However, the Department CBOs, and improve family engagement the point scale or rubric be disclosed. will not give ‘‘extra credit’’ to States that are specifically encouraged in the Other commenters suggested that the have recently enacted laws or polices school intervention models in Appendix point allocations be subject to public intended to support their Race to the C. Top applications, as that would Changes: None. comment. One commenter suggested Comment: One commenter suggested that Secretary Duncan make the final penalize early reformers. Finally, as is made clear elsewhere in this notice, the that the Department release guidance to award selections. selection criteria are not eligibility help States determine whether they are Discussion: To ensure that the Race to likely to be successful in competing for the Top competition is as open and requirements; the failure to meet any single criterion, or even a number of Race to the Top funds as judged by their transparent as possible, the Department NAEP scores. The commenter suggested is publishing the reviewer scoring rubric criteria, will not preclude a State from receiving a Race to the Top award. that States with low NAEP scores are in Appendix B of this notice. The rubric Moreover, the large number of criteria unlikely to receive funds and would be is designed to ensure consistency across for which a State may earn points means wasting tremendous resources in reviewers and help applicants better that an application that is exceptionally completing a Race to the Top understand the Department’s priorities strong on a majority of, but not all, Race application. for this competition by clearly to the Top selection criteria may score Discussion: The Department has identifying the point allocations for higher than an application that earns created a scoring rubric with the each selection criterion and indicating only partial credit on every criterion. On number of possible points for each how priorities will be judged. The the other hand, applicants should keep selection criterion. The rubric will be Secretary will select the grantees after in mind the statutory emphasis on used by reviewers to judge State considering the rank order of comprehensive reforms, as well as applications for Race to the Top funds. applications, each applicant’s status absolute priority 1, which requires an The Department is including the rubric with respect to the Absolute Priority applicant to address comprehensively in Appendix B to ensure that the scoring and eligibility requirement (a), and any all four ARRA assurance areas as well of State applications is transparent and other relevant information. Grant award as the State Success Factors (Section so that States are fully informed as they decisions are made by the Secretary, (A)) of the selection criteria. develop their applications. We note that pursuant to the Department’s Changes: None. the criterion referenced by the regulations. It is the Department’s Comment: Many commenters commenter (proposed criterion practice to first take public comment on recommended that the Department (E)(1)(iv), which has been revised and proposed selection criteria before heavily weight the selection criteria for designated as criterion (A)(1)(iii)), making final decisions on those criteria. turning around struggling schools. focuses on improvements in This allows the Department to consider Another commenter suggested a achievement, and not simply whether a public comment on the proposed weighting system that rewards States for State has high or low scores, as reported selection criteria before making final providing flexibility or autonomy to by both the NAEP and the assessments decisions on point allocations, which schools, whether charter or traditional. required under the ESEA. are then published in the application One commenter suggested awarding a Changes: None. package and final notice inviting significant portion of points for Other Education Reform Strategies applications. activities that support science, Changes: The scoring rubric for the technology, engineering, and Comment: Many commenters criteria is included as Appendix B. mathematics (STEM) initiatives; needy suggested that Race to the Top take into Comment: Many commenters locations; turning around school account existing State and local recommended weighting State Reform climate; partnerships with community education reform strategies, particularly Conditions Criteria more heavily than based organizations and volunteers; and in high-need schools. Several Reform Plan Criteria, arguing that States family engagement. commenters suggested that Race to the that have already enacted reform Discussion: The Department believes Top include reform initiatives policies are more likely to accelerate that each of the four reform areas is specifically targeted to high schools, the student achievement. On the other critical and has assigned points learning needs of advanced students, or hand, one commenter suggested that accordingly. The Department, therefore, the attainment of ‘‘21st Century Skills’’ States be given extra credit for recently declines to heavily weight the selection (described in the comments as skills enacted regulatory or legislative criteria for turning around struggling pertaining to media, technology, and reforms, particularly in Phase 2 of the schools or to provide extra points to financial literacy and global awareness). Race to the Top competition. Several States that provide flexibility and One commenter urged a greater focus in other commenters recommended that autonomy to its schools. We decline to Race to the Top on ‘‘disruptive the Department ensure that no single award a significant portion of points for innovations’’ such as online learning, criterion or assurance, by itself, operate activities that support STEM initiatives, while others championed specific to eliminate a State from the Race to the needy locations, school climate, subjects, such as music and the arts, as Top competition. One of these partnerships with community based essential ways of engaging students in commenters argued that States need organizations and volunteers, and learning and keeping them in school. In flexibility, while another commenter family engagement. We note that each of addition, several commenters argued added that a State application that these areas already is addressed in this that the study of foreign languages is addresses some criteria in depth may be notice. For example, a State that critical for our future competitiveness in stronger than one that addresses all includes STEM education in its the global economy and should be criteria but is ‘‘shallow’’ in its overall comprehensive plan will be eligible to included as a priority in the Race to the approach. receive competitive preference points; Top program.
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Discussion: The Department instructional improvement based on Discussion: Section 14006(a)(2) of the recognizes that numerous strategies, what works in the classroom. One key ARRA specifically states that ‘‘the interventions, technologies, and subjects purpose of Race to the Top is to Secretary shall make grants to States can make meaningful contributions to empower cutting-edge States and LEAs that have made significant progress’’ in improving the quality of our education to build on what works while also meeting the objectives of the four reform system, engaging students, and turning creating new, more effective models of areas. As such, the Department does not around the lowest-achieving schools. educational reform and improvement have the authority to expand the We also agree that it is important to give that will significantly expand our statute’s directive to extend eligibility to States credit for existing reforms that are collection of evidence-based practices. the other entities suggested by the achieving positive outcomes. This is one We believe that State flexibility is key commenters. The Department reason why we are clarifying and in this effort. recognizes, however, that these entities expanding criterion (F)(3) (proposed Changes: None. and others within the State are essential criterion (E)(1)(iii)) which, as mentioned Support for Traditional Public Schools to the success of Race to the Top earlier, asks States to demonstrate the grantees. For this reason, we are adding extent to which they have created Comment: One commenter claimed additional examples of stakeholders to conditions favorable to education that the Race to the Top program, as State Success Factors Criterion reform or innovation, in addition to the outlined in the NPP, would result in (A)(2)(ii)(b) (proposed criteria (E)(3)(i) information provided under other State little or no support for traditional public and (ii)), which specifically asks Reform Conditions Criteria. We also schools because it seemed primarily applicants to demonstrate the extent to note that under the State Reform concerned with creating ‘‘financial which they have secured broad Conditions Criteria, States will be opportunities for educational stakeholder support. In addition, rewarded for having put into place key entrepreneurs.’’ participating LEAs may use their funds conditions for reform, while the State Discussion: This commenter to serve non-Title I schools, if doing so Reform Plan Criteria asks States to misconstrues Race to the Top, which is aligns with the State’s plan and the create plans that build on their focused almost entirely on improving Department’s general regulations on successes. our traditional public schools. uses of funds. States also may, Changes: Criterion (F)(3) (proposed Furthermore, pursuant to section consistent with applicable procurement criterion (E)(1)(iii)) has been clarified 14006(c) of the ARRA, at least 50 requirements, contract with and expanded to focus on the extent to percent of Race to the Top funds must organizations such as those mentioned which a State, in addition to be allocated directly to LEAs according by the commenters, using the State’s information provided under other State to their relative shares of funding under share of Race to the Top funds. Reform Conditions Criteria, has created, Title I, Part A of the ESEA; a majority Changes: Criterion (A)(2)(ii)(b) has through law, regulation, or policy, other of those LEAs are likely to serve been expanded to include additional conditions favorable to education exclusively traditional public schools. examples of stakeholder support. reform or innovation that have Further, each of the four assurances Comment: Some commenters increased student achievement or under the ARRA, which provide the suggested that private schools be graduation rates, narrowed achievement overall framework for the Race to the eligible for Race to the Top funds. One gaps, or resulted in other important Top program, is aimed at increasing the commenter argued that services to outcomes. effectiveness of State and local support students and teachers in private schools for traditional public schools. is permitted under the Stabilization Evidence-Based Practices in Race to the Changes: None. Fund and, therefore, should be Top Eligibility of Other Entities permitted under the Race to the Top Comment: Some commenters argued program. The commenter stated that that the Race to the Top program, as Comment: Several commenters section 14006(b) of the ARRA leaves outlined in the NPP, would not suggested that entities other than States considerable discretion to the Secretary adequately support evidence-based be made eligible to apply directly for in awarding grants on the basis of State practices. One of these commenters Race to the Top funds. Specifically, applications for the Stabilization Fund suggested including a minimum commenters suggested that such and argued that this latitude extends to evidence threshold for each of the State organizations as charter schools, Race to the Top funds. The commenter Reform Plan Criteria. independent school districts, requested that the overall selection Discussion: We believe that the use of community colleges, historically black criteria be amended to include a evidence-based practices is critical to colleges and universities, LEAs, and criterion that focuses on applicants’ the success of the Race to the Top not-for-profit organizations partnering compliance with statutory provisions program. However, we acknowledge with either LEAs or universities be able related to the equitable participation of that the research evidence to support to apply for Race to the Top funds. private school students and teachers in education practices, strategies, and Those commenters argued that Federal education programs. programs may not reach the same preventing these entities from applying Other commenters recommended that threshold for each reform area. The four for the Race to the Top competition the notice encourage States to include education reform areas in the ARRA are would limit the creation of innovative faith-based schools in their applications. in large part focused on giving educators partnerships. Other commenters These commenters pointed to positive new data-based tools for developing and requested that private schools and non- effects on at-risk youth attributed to implementing their own best practices. profit organizations that partner with Catholic and other faith-based schools. Indeed, developing stronger standards LEAs be eligible. Another commenter A few commenters specifically and assessments, expanding the use of suggested that municipalities, in requested that faith-based schools be longitudinal data systems, improving addition to LEAs, should be eligible to eligible to apply for Race to the Top teacher and principal effectiveness, and receive Race to the Top subgrants. One funds directly. One commenter noted supporting struggling schools are all commenter was supportive of States that because private school students intended to create and support applying directly for funds as opposed participate in Title I, Part A programs evidence-driven continuous to LEAs. under the ESEA, they should be allowed
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to participate in the Race to the Top Discussion: The commenters are Top program, which will award only activities approved in a State’s plan. correct that the ARRA offers few about 4 percent of all education funds Other commenters requested that specifics governing the Race to the Top provided by the ARRA, was specifically private schools that partner with LEAs program; however, the ARRA is very intended to encourage and reward those be made eligible to receive Race to the clear that (1) The program is expected States that are making ‘‘significant Top funds. One commenter asserted that to provide incentives for ‘‘significant progress’’ toward the four assurances. private schools should have the option progress’’ in the four assurance areas, This final notice, like the NPP, to participate in all Federal programs and (2) the Secretary has authority to represents our effort to establish without sacrificing control in such areas award Race to the Top funds using reasonable and appropriate criteria for as curriculum, hiring, or teacher ‘‘such criteria as the Secretary defining the ‘‘significant progress’’ as requirements. determines appropriate.’’ Moreover, required by the statute. Discussion: As described in the section 410 of the General Education Changes: None. response to the previous set of Provisions Act (20 U.S.C. 1221e–3) gives Promoting Successful Implementation comments related to eligibility, the the Secretary full authority to Comment: Several commenters raised statutory language of the ARRA promulgate rules and regulations questions concerning the specifically provides that States are the necessary for the effective implementation of Race to the Top. One eligible applicants for Race to the Top administration of Federal education commenter expressed concern that the funds, and that only LEAs are eligible to programs. This final notice, like the proposed priorities pertained to State receive subgrants from the States. Race NPP, is consistent with these rather than LEA functions. The to the Top funds may not be provided authorities. commenter noted that States do not to private schools through a grant or Moreover, the ARRA specifically achieve significant improvements in subgrant, and there is no requirement provides that Race to the Top funds must be awarded not later than student outcomes; rather teachers that private school students, teachers, or working in LEAs with students, parents, other educational personnel participate September 30, 2010. In order to provide States the maximum amount of time school administrators, and other in Race to the Top on an equitable basis stakeholders make the difference. (as required in some programs in the possible to plan, organize, and draft their applications for the Phase 1 and Another commenter urged us to make ESEA). Furthermore, Race to the Top Race to the Top awards as soon as funds may not be used to provide Phase 2 competitions, while still allowing and responding fully to public possible, but not later than early 2010, financial assistance to students to attend so that States and school districts can private schools. However, States and comment, the Department sought comment on the NPP for a 30-day time begin implementing reforms in the LEAs have the flexibility to include period. Notably, section 437(d)(1) of the 2010–2011 school year. Two private school students, teachers, and General Education Provisions Act, 20 commenters suggested that we will not other educational personnel in activities U.S.C. 1232(d)(1), allows the be able to create the momentum to that the States and LEAs deem Department to waive rulemaking for the accomplish national education reform appropriate, and may contract with first grant competition under a new or unless a sufficient number of States private schools for appropriate secular substantially revised program authority. receive Race to the Top funds. One activities, consistent with the State’s The Race to the Top program is a new commenter suggested that the Race to plan. program, so the Department was not the Top program would have a broader Changes: None. required to conduct notice-and- national impact if 26–30 States Authority for the NPP comment rulemaking. The Department, participated in the program, and however, instead of taking advantage of recommended structuring the award Comment: Some commenters objected that option, specifically sought public phases so that the first round provides to the NPP, arguing that it proposed comment in order to inform the large ‘‘lead’’ grant awards followed by a education policy outside of the development of the program. Moreover, second round of smaller ‘‘but still legislative process. One commenter the comments received from over 1,100 substantial’’ awards. claimed that while the ARRA ‘‘imposes commenters during the NPP’s 30-day Discussion: The Department agrees only brief and general requirements’’ comment period suggest that this period that the success of a State’s Race to the governing the use of Race to the Top of time was sufficient for broad public Top reform efforts will depend on its funds, the prescriptive proposals in the review and comment. ability to articulate a comprehensive NPP ‘‘amount to writing new laws.’’ In response to claims that the Race to and coherent education reform agenda, One commenter recommended that the Top requirements would interfere secure the commitment of its LEAs to Congress hold hearings on the notice, with State, local, or Tribal governments implement on its proposed plans, and claiming that there has been a lack of or impose policies on these provide leadership and support to its sufficient time to review the NPP. governments, we note that the Race to LEAs. We recognize that the most Another commenter asserted that the Top program is a voluntary important reform efforts will take place Congress should conduct a broad review competitive grant program that, like in the classroom and that a critical part of the NPP and of our determination other such programs, includes of a State’s application will be the that the NPP would ‘‘not unduly requirements and criteria that must be State’s capacity to support its LEAs in interfere with State, local, and Tribal met in order for States to participate and successfully implementing its plans governments in the exercise of receive funding. States and LEAs that do through such activities as identifying governmental functions.’’ Two not wish to comply with these best practices, widely disseminating and commenters also stated that it appeared conditions and criteria are not required replicating effective practices statewide, that we were using Race to the Top, in to apply for a grant. While the fiscal and holding LEAs accountable for the context of the fiscal emergency crises currently faced by many States progress and performance. currently faced by many States, to may encourage States to apply for Race We are aware of the need for impose education reform policies that to the Top funds, ameliorating State and successful applicants to begin would not otherwise be accepted by local deficits is not the primary purpose implementing their Race to the Top States and LEAs. of this program. Instead, the Race to the plans as soon as possible. Toward this
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end, we expect to make Phase 1 Race to elsewhere in this notice, the Department budgets that are above or below the the Top awards in the first half of believes that this language strikes the suggested ranges. The amount awarded calendar year 2010. We do not agree that right balance between encouraging in Phase 1 will depend on the quality Race to the Top funds should be spread States to set a high bar for Race to the of the applications that States submit to across an arbitrarily larger number of Top goals while recognizing that real the Department, as well as the States. Instead, the size and number of change in education is difficult and successful applicants’ proposed Race to the Top awards in the two takes time. The goal is to encourage budgets. It is our intention to have phases of funding will depend on the realistic thinking and planning that significant funds available for Phase 2 scope and quality of the applications connects specific activities to specific, applicants and awards. The ARRA does that States submit to the Department. achievable results, while acknowledging not provide funding to help States Changes: None. that improvements in the Nation’s prepare or design their Race to the Top Comment: Several commenters education system are urgently needed applications. requested clarification regarding how and the country’s children cannot wait. Finally, the Department has taken States should develop and use Changes: None. extraordinary measures to ensure performance and data indicators. One Comment: One commenter expressed accountability in the use of all ARRA commenter suggested requiring States to concern that too many of the measures funds, including the Race to the Top provide information on the extent to proposed in the NPP reflect past fund, so that all dollars are used wisely which LEAs in the State have made performance and recommended a and accounted for in a transparent adequate yearly progress (AYP) as part greater emphasis on future Race to the manner. Indeed, as explained in the of their annual reports. Other Top performance. Reporting section of this final notice commenters called for the Department Discussion: The emphasis on past and in the notice inviting applications, to peer-review annual State Race to the performance comes directly from the successful applicants must comply with Top reports. Two commenters expressed requirements in the ARRA, which the ARRA annual reporting concern that performance measures requires States to have made significant requirements in section 14008 of the would vary from State to State, causing progress in the four education reform ARRA and with quarterly reporting confusion in the field. Finally, one areas in order to receive a grant. Once requirements in section 1512(c) of the commenter recommended that the Race to the Top grants are awarded and ARRA, which are designed to ensure Department remove the phrase winning States begin implementing thorough and public oversight of the ‘‘ambitious yet achievable’’ because its their reform plans, the Department will expenditure of ARRA funds. In meaning is unclear. become far more focused on how States addition, the Department has Discussion: In the NPP the perform under this program. established a Recovery Act Web site and Department proposed core performance Changes: None. hotline for members of the public to measures for evaluating the performance Race to the Top Funding report suspected misuse of funds. of States receiving Race to the Top Changes: None. funds against both the four assurances Comment: Several commenters Comment: One commenter expressed and specific elements of State Race to suggested that the Department provide concern about structuring the Race to the Top plans (see Appendix A). For the more information on expected funding the Top program as a competitive grant. most part, we are retaining these levels for States that receive Race to the The commenter noted that structuring measures, with some modifications, in Top funds, including the number and the program this way will mean that not this notice. The Department size of Race to the Top awards for both every State will win Race to the Top understands the concerns expressed by the Phase 1 and 2 competitions. grant funds. Another commenter stated commenters about comparability of data Multiple commenters suggested that we that by predetermining ‘‘the conditions across States receiving Race to the Top provide funding for States to develop necessary for reform,’’ the winners and grants; this is one reason that this final reform plans and applications. One losers have already been chosen. notice retains the request for States to commenter requested assurances that Discussion: The Race to the Top set student achievement and gap-closing the level of funding to successful State program is intended to promote and goals based on NAEP data in revised applicants will be sufficient to carry out reward States making the most progress criterion (A)(1)(iii) (proposed criterion all activities in States’ reform plans. in achieving the goals described in the (E)(4)). NAEP scores are comparable Two commenters expressed concern ARRA and by the Secretary. As the across States, thus eliminating concerns that LEAs will have control of ARRA Secretary and the President have said, about the widely varying standards and funds, outside of public accountability Race to the Top is designed as a assessments in use by States under and without provisions for oversight, competitive, once-in-a-lifetime ESEA accountability systems. while another commenter requested opportunity for the Federal Government States already issue annual reports on information about the restrictions on the to create incentives for far-reaching AYP status for schools and LEAs, usage of Race to the Top funds, and an improvement in our Nation’s schools. including proficiency rates for all explanation of how States are expected While other ARRA funds provide schools; there is no need to duplicate to use them. substantial increases in formula funds to this reporting by requiring its inclusion Discussion: We encourage States to States (e.g., the Stabilization Fund, in a State’s annual Race to the Top develop budgets that match the needs ESEA Title I, IDEA), we strongly believe report. However, States that desire to they have outlined in their applications. that the competitive nature of the Race include AYP data in their annual Race To support States in planning their to the Top program will encourage to the Top reports are free to do so. The budgets, we have developed nonbinding statewide reform resulting in significant Department declines to add a budget guidance with ranges for each improvement in student outcomes. requirement for peer review of these State; these are listed in the notice Finally, we note that contrary to the annual reports. inviting applications, published suggestion made by one commenter, the Finally, we are retaining the elsewhere in this issue of the Federal Department has not pre-selected the ‘‘ambitious yet achievable’’ language Register. These ranges may be used to winners and losers for this competition. throughout the Race to the Top State guide States as they draft their Applications will be judged based on Reform Plan Criteria. As noted applications, but States may prepare the conditions States have put in place
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by the time they apply, the strength of share of Race to the Top funds, ‘‘underfunded mandate’’ and argued their plans, and how these come including: Serving high-need students that it would impose additional costs on together as a coherent and cohesive in non-Title I schools, State-level State and local taxpayers. strategy to improve student outcomes. activities in support of Race to the Top Discussion: While the Race to the Top Changes: None. plans, competitive or formula-based program is intended to support a comprehensive approach to developing Flexibility to Allocate Funds subgrants to LEAs, contracts with non- profit organizations, or supporting the and carrying out critical change and Comment: Several commenters sought participation of private school students reform in the four assurance areas, greater flexibility for States and LEAs to and teachers in Race to the Top. States have flexibility to tailor their determine award levels. For example, a Changes: None. Race to the Top budgets and spending few commenters suggested that Comment: One commenter stated that plans according to both the relative allocating 50 percent of Race to the Top a portion of the Race to the Top funds priority of plan activities and the funds by formula runs counter to the should be set aside for LEA–IHE availability of funding from other program’s goals, and that States should consortia to develop training that would Federal, State, and local sources, be allowed to focus funding on LEAs allow for the development and consistent with criterion (A)(2)(i)(d) with the greatest need for additional implementation of systemic P–20 (proposed criterion (E)(5)(v)). For resources to address the educational collaboration, facilitate curricular example, States may use their Title I needs of at-risk students such as English alignment, and promote seamless School Improvement Grants to execute language learners, students with transitions from high school to college. most of their plans under criterion (E)(2) disabilities, and students from low- Discussion: As noted in the previous (proposed criterion (D)(3)), thereby income families, or to give priority to comment, section 14006(c) of the ARRA allowing themselves to dedicate a one or more of the four assurances when requires a State that receives a Race to higher proportion of Race to the Top funding LEAs. Other commenters the Top grant to use at least 50 percent funds to activities in the other three sought clarification about State of the award to provide subgrants to assurance areas. Similarly, a State that flexibility in using the 50 percent of LEAs, including public charter schools receives a Statewide Longitudinal Data funds that will not be distributed on the identified as LEAs under State law. The Systems grant might use these funds to basis of the Title I formula. One ARRA does not require or specify that enhance its data systems work and commenter suggested that States might funds should be set aside for any other could, therefore, focus its Race to the use their shares of Race to the Top specific purposes; therefore, we decline Top funding on other assurance areas. awards to support high-need students in to require that a portion of the Race to Also, the selection criteria include non-Title I schools, while another the Top funds be set aside for LEA–IHE elements intended to help ensure that proposed allowing States to use these consortia as recommended by the funding issues do not derail Race to the funds for State-level activities or to commenter. However, States are Top plans. For example, under criterion make their own formula or competitive welcome to include such expenditures (F)(1), States are asked to demonstrate subgrants. Another commenter asked in their proposals if they align with the extent to which (i) the share of whether LEAs can serve non-Title I their plans. We also note that IHEs are overall State revenues supporting schools in their districts with their 50 critical partners in implementing education in FY 2009 was greater than percent share, and whether use of these significant reforms, particularly in or equal to the share provided for funds must also adhere to Title I ensuring that a State’s longitudinal data education in FY 2008; and (ii) the regulations. system can provide data to assess the State’s policies lead to equitable funding Discussion: Section 14006(c) of the extent to which students are adequately (a) between high-need LEAs and other ARRA requires at least 50 percent of prepared for success in post-secondary LEAs, and (b) within LEAs, between Race to the Top funding to States to be education. As noted elsewhere, we are high-poverty schools and other schools sub-granted to participating LEAs adding language to criterion (B)(3) to (new criterion). In addition, criterion according to their relative shares of acknowledge the role that IHEs may (A)(2)(i)(e) (proposed criterion funding under the ESEA Title I, Part A play in supporting the transition to (E)(5)(iii)) addresses whether a State has program for the most recent year. enhanced standards and high-quality explained in its application how it will Neither the Department nor the States assessments. In addition, as noted use its fiscal, political, and human have discretion to deviate from this elsewhere, we are adding ‘‘institutions capital resources to continue Race to the allocation requirement. LEAs that agree of higher education’’ in criterion Top reforms after the period of funding to work with the State to implement the (A)(2)(ii)(b) as an example of a type of has ended. Finally, because the Race to State’s Race to the Top plan may use stakeholder from whom a State should the Top is a voluntary, competitive these funds to serve non-Title I schools. enlist support and commitment to assist grant program, it does not impose costs Because these are not Title I program in the State’s education reform efforts. on any State or local taxpayers, and thus funds, LEAs are not required to adhere Changes: None. does not meet any reasonable definition to Title I regulations regarding the usage of an underfunded mandate. of those funds. Fund uses, however, Sustaining Race to the Top Reforms Changes: Criteria related to budget must be consistent with the State’s plan Comment: One commenter expressed planning and funding have been and the Department’s general concern that the requirements and modified and rearranged in this final regulations on uses of funds. activities proposed in Race to the Top notice to promote the development and In addition, States have considerable would not be fully paid for by Race to submission of more coherent Race to the flexibility in awarding or allocating the the Top awards, and that these activities Top plans. Criterion (A)(2)(i)(d) asks remaining 50 percent of their Race to would ‘‘be difficult to sustain States to demonstrate through their the Top awards, which are available for operationally and financially.’’ This budget narratives and accompanying State-level activities, disbursements to commenter recommended a sharper budgets the extent to which they have LEAs, and other purposes as the State focus in the final notice on the high-quality plans to use Race to the may propose in its plan. Many of the requirements ‘‘of greatest importance.’’ Top funds to accomplish their plans and activities recommended by commenters In a related comment, one individual meet their targets, including, where would be allowable uses of the State’s described Race to the Top as an feasible, coordinating, reallocating, or
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repurposing education funds from other principals at higher rates than other promote integration. Another Federal, State, and local sources to align students. commenter recommended adding a with their Race to the Top goals. However, we agree that in this final criterion requiring a high-quality plan Criterion (A)(2)(e) (proposed criterion notice, the Department should place for a State to substantially reduce the (E)(5)(iii)) will help ensure that States greater emphasis on equitable funding isolation and segregation of low-income have plans to continue support for Race of high-need LEAs and students. For students, through intra- or inter-district to the Top reforms once Race to the Top this reason, we are adding criterion collaboration, magnet schools, transfer funds have been spent. (F)(1)(ii), which examines the extent to programs, or school restructuring and which a State’s policies lead to consolidation. One commenter Addressing Obstacles Created by equitable funding (a) between high-need suggested adding requirements that Poverty LEAs (as defined in this notice) and State proposals reduce school-based Comment: One commenter asserted other LEAs, and (b) within LEAs, poverty concentrations and racial that overcoming achievement gaps—a between high-poverty schools (as isolation in schools. Another key goal of the Race to the Top defined in this notice) and other commenter wrote that the NPP program—would require addressing schools. overlooked ‘‘the continuing importance obstacles to high academic achievement Changes: The addition of criterion of avoiding racial and economic created by the conditions of poverty. (F)(1)(ii) establishes a new State Reform segregation in public schools, and This commenter urged that Race to the Condition Criterion that will consider promoting voluntary integration’’ and Top be used to promote the extent to which a State’s policies urged that the final notice promote these ‘‘comprehensive educational lead to equitable funding (a) between goals. opportunity’’ for all students, but high-need LEAs and other LEAs, and (b) Discussion: Racial and economic particularly for those from low-income within LEAs, between high-poverty diversity are laudable goals that the families. Other commenters argued that schools and other schools. Department supports. The Race to the Race to the Top plans should include Civil Rights Enforcement Top program encourages innovative solutions to important problems facing efforts and incentives to ensure the Comment: Several commenters raised adequacy and equity of State and local our Nation’s schools, which could concerns about the NPP as it relates to include appropriate approaches to education funding, such as by civil rights laws and discrimination rewarding States that have taken steps further racially and economically based on race and sex in schools. One diverse schools. However, we have not to allocate resources and inputs commenter recommended that the equitably. added this objective as an invitational Department include language in the priority in the Race to the Top program. Discussion: The Secretary believes final notice reminding States of their We note that the Department has for that a high-quality education is the obligations under anti-discrimination many years administered the statutory surest route out of poverty. However, statutes, including Title IX of the Magnet Schools Assistance Program, 20 while broader societal problems such as Education Amendments Act of 1972. U.S.C. 7231. This program provides the lack of affordable housing or access Discussion: The Department believes grants to LEAs to fund magnet schools to health care certainly make the jobs of in promoting educational excellence that—in addition to strengthening schools serving disadvantaged students throughout the Nation through vigorous students’ academic knowledge and their more challenging, they should not be enforcement of civil rights laws. The attainment of tangible and marketable used to excuse the lack of achievement Department’s Office for Civil Rights is skills—will further the ‘‘elimination, in high-need schools. Race to the Top is specifically tasked with enforcing reduction or prevention of minority structured to promote comprehensive several Federal civil rights laws that group isolation’’ in elementary and educational reforms benefitting all prohibit discrimination in programs or secondary schools. 20 U.S.C. 7231(b). students while targeting additional activities that receive Federal financial Changes: None. attention and resources towards high- assistance from the Department, and Family and Community Engagement need LEAs and toward the persistently issuing guidance to school districts on lowest-achieving schools that typically how to comply with those laws. Since Comment: Many commenters stressed enroll a disproportionate number of SEAs and LEAs are ongoing recipients the importance of including parents, students from low-income families. For of Federal financial assistance, they are students, family, and community example, 50 percent of Race to the Top aware of these civil rights laws. We members ‘‘as equal partners’’ in funding must be subgranted by States to believe, therefore, that reiteration of developing States’ Race to the Top LEAs on the basis of their relative shares State responsibilities under various civil plans. One commenter urged that the of formula grant allocations under Title rights laws in the final notice is final notice require States and LEAs to I, Part A of the ESEA, which are based unnecessary. document the involvement of parents in largely on counts of children from low- Changes: None. developing their Race to the Top plans, income families residing in the Comment: One commenter suggested while another commenter recommended communities served by those LEAs. that the notice include language the inclusion of parent and student Also, under criterion (E)(2) (proposed requiring States to support voluntary accountability measures in Race to the criterion (D)(3)), States will create school integration efforts. Another Top plans. One commenter urged that comprehensive school intervention commenter recommended adding an the Department and participating States plans for the persistently lowest- invitational priority for innovative keep parents informed of Race to the achieving schools. Furthermore, under approaches to voluntary school Top activities using materials written in criterion (D)(3) (proposed criterion integration in order to encourage inter- ‘‘easy-to-understand language’’ and, (C)(3)), States will be evaluated on their district magnet schools and new charter where necessary, multiple languages. plans to ensure that students in high- schools that achieve racial and Several commenters stated that family poverty and/or high-minority schools economic integration. The commenter engagement policies and practices that have equitable access to highly effective also recommended adding an are culturally and linguistically teachers and principals and are not invitational priority to encourage the appropriate are essential components of served by ineffective teachers and use of inter-district school transfers to comprehensive services to high-need
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students. A few commenters to demonstrate statewide support for its meet the priority (see 34 CFR recommended that school personnel Race to the Top plan. 75.105(c)(3)). Under a competitive work with community partners to align preference priority, the Secretary may I. Final Priorities school, family, and community assets award bonus points to an application and expertise in order to support General Comments on Proposed depending on the extent to which the student achievement (e.g., centers of Priorities application meets the priority or may community, community schools, Comment: We received a number of select an application that meets the community learning centers, full service comments that addressed more than one priority over an application of comparable merit that does not meet the community schools). Many commenters proposed priority or that focused on a stressed the importance of family and priority (see 34 CFR 75.105(c)(2)). And, proposed priority as well as on specific community involvement in local school under an invitational priority, the selection criteria. Secretary may simply invite turnaround strategies. Several Discussion: In some cases we have commenters also noted that the terms applications that meet the priority; an responded to comments received in ‘‘family engagement’’ and ‘‘community application that meets the invitational response to more than one priority or engagement’’ should be separated, priority, however, receives no that focused on a priority and selection arguing that these concepts involve competitive or absolute preference over criteria in this ‘‘General Comments on different stakeholders and require other applications (see 34 CFR Proposed Priorities’’ section. In other different strategies. 75.105(c)(1)). Discussion: The Department agrees cases, we decided that it would be more The designation of priorities as that States’ Race to the Top plans would appropriate to respond to the comments invitational in the NPP and in this final benefit from documented input and in the ‘‘General Comments on the Race notice demonstrates the Department’s involvement by parents and to the Top Program’’ earlier in this interest in particular topics or issues organizations that represent parents, notice. This enabled us to group similar and applicants’ interest in and capacity students, families, and community comments and concerns in order to be to address those areas. Applicants are members. To encourage States to do so, more responsive to the commenters. not required to address these we are adding, in criterion (A)(2)(ii)(b) Changes: None. invitational priorities in their (proposed criterion (E)(3)(ii)), Tribal Comment: One commenter stated that applications. Because the Department is schools; and parent, student, and including absolute, competitive interested in State focus and capacity in community organizations among the preference, and invitational priorities in the areas identified as invitational stakeholders from which a State could the NPP was confusing and undermined priorities, we decline to remove them in obtain statements or actions of support the review process by suggesting that this final notice. to demonstrate statewide commitment the Department does not have a clear In this final notice, we are designating to its Race to the Top plan. At the local sense of what is important. Another priority 1, Comprehensive Approach to level, criterion (E)(2) and Appendix C commenter recommended eliminating Education Reform, as an absolute (proposed criterion (D)(3)) support the invitational priorities claiming that priority that all applicants must meet. greater parent involvement in they provide no competitive advantage Priority 2, Emphasis on Science, individual school turnaround plans and in the grant competition and distract Technology, Engineering, and the turnaround model and the from the key elements of the program. Mathematics (STEM), has been transformation model in particular. The One commenter requested that the designated as a competitive preference Department views such mechanisms not final notice include an explanation of priority for which a State can receive only as opportunities for parents to the differences and significance of the additional points (see Appendix B for participate in turnaround planning but competitive preference priority for the scoring rubric). Finally, we are also for LEAs and schools to promote STEM and the invitational priorities for including the following invitational greater accountability for parents and data systems, P–20 coordination, and priorities: Priority 3, Innovations for students in areas such as school school-level conditions for reform and Improving Early Learning Outcomes; attendance, homework completion, and innovation. Another commenter asked priority 4, Expansion and Adaptation of monitoring student achievement. In whether different weights will be Longitudinal Data Systems; priority 5, addition, the Department believes that assigned to the absolute priority versus P–20 Coordination, Vertical and any mechanism for family and the competitive preference and Horizontal Alignment; and priority 6, community engagement naturally would invitational priorities. School-Level Conditions for Reform, require keeping parents informed of Two commenters expressed concern Innovation, and Learning. Unless Race to the Top-related activities, with the statement in the NPP that the certain exceptions apply, the including providing information in Secretary reserves the right to propose Department must conduct notice-and- multiple formats and languages, where additional priorities, requirements, comment rulemaking when establishing necessary. However, the final notice definitions, or selection criteria. These absolute and competitive preference retains flexibility for LEAs to determine commenters requested that any priorities. See 34 CFR 75.105(b)(2). the nature of these mechanisms and additional priorities, requirements, Notice-and-comment rulemaking is not does not specifically require plans to definitions, or selection criteria be required for the Department to establish include separate parental involvement published in the Federal Register and invitational priorities. See 34 CFR programs. that the public be given the opportunity 75.105(b)(2)(i). As noted by one Changes: Criterion (A)(2)(ii)(b) adds to comment on them. commenter, we stated in the NPP that ‘‘Tribal schools; parent, student, and Discussion: The Education the proposed priorities could be community organizations (e.g., parent- Department General Administrative changed in the final notice, and that the teacher associations, nonprofit Regulations (EDGAR) in 34 CFR Department may propose additional organizations, local education 75.105(c) identify the types of priorities priorities, requirements, definitions, or foundations, and community-based the Department may establish for its selection criteria, subject to applicable organizations)’’ to the list of stakeholder direct grant programs. Under an rulemaking requirements. As indicated groups from which a State can obtain absolute priority, the Secretary elsewhere, we are adding a new statements or actions of support in order considers only those applications that invitational priority 3, Innovations for
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Improving Early Learning Outcomes, priority focused on literacy preschool years. Many commenters based on comments received on the development for young children; requested that the final notice include a NPP. Since the priority is invitational reading and writing skills for young competitive preference priority focused only, we were able to include it in this students; and higher-order literacy skills on early learning programs. One final notice without additional public for adolescent students (e.g., ability to commenter stated that a competitive comment. analyze diverse texts and write using preference priority on early learning Changes: None. critical reasoning). Many commenters should focus on increasing the number Comment: Several commenters also proposed that priority be given to of low-income children in high-quality recommended that invitational States that prepare more students pre-K programs. Other commenters priorities 4, 5, and 6 be changed to (particularly low-income students, recommended requiring a quality early competitive preference priorities given English language learners, and students learning strategy as part of a State’s plan the importance of each of the priorities with disabilities) for success in school for turning around struggling schools. A and the need for States to have an and for graduation from high school number of commenters suggested that integrated and coordinated reform ready for college and work, and with such a strategy could include expanded strategy. One commenter recommended skills to meet the literacy demands of pre-K funding and programs, aligned that additional points be given to a State high-growth, high-wage jobs. Another standards and assessments for pre-K that demonstrates how all the commenter suggested that the final through third grade, links between invitational priorities are integrated in notice include access to high-quality longitudinal data systems and pilot its overall reform strategy. school libraries as part of the criteria. ‘‘Quality Rating and Improvement Discussion: We believe that priorities Discussion: Advancing the literacy Systems’’ to improve instruction, and 4, 5, and 6 are appropriately designated skills of all students, particularly increasing the availability of as invitational priorities. Although the students from low-income families, credentialed pre-K through third-grade Secretary is interested in receiving English language learners, and students teachers. applications addressing these priorities, with disabilities, is the foundation for Another commenter recommended each of the priorities extends or many of the criteria in the Race to the that States be required to address the complements the core reform work that Top competition. For example, a State following issues to strengthen the States must already address in their will be judged on the extent to which it quality of early care and education applications. For example, priority 4, has made progress over the past several programs: (1) Appropriate compensation Expansion and Adaptation of Statewide years in each of the four education to attract and retain talented Longitudinal Data Systems, extends reform areas, and used its ARRA and administrators and teachers in early care States’ core work in developing other Federal and State funding to and education programs; (2) the need for statewide longitudinal data systems; pursue such reforms (see criterion a technological infrastructure to (A)(3)(i)). A State will be judged on the priority 5, P–20 Coordination, Vertical establish a data-driven decision-making extent to which it has demonstrated a and Horizontal Alignment, system, as well as to document the track record of improving student complements States’ core reform efforts benefits of early care and education achievement overall and by student in the K–12 education systems and services; (3) creation of a State-level subgroup in reading/language arts and extends them to the larger P–20 advisory body to develop a State early mathematics, decreasing the education systems; and priority 6, learning plan, monitor the achievement gaps between subgroups in School-level Conditions for Reform, implementation of the plan and reading/language arts and mathematics, Innovation, and Learning, is a natural recommend adjustments to strengthen and increasing high school graduation extension of the work States are doing strategies as the plan is implemented; to create, through law, regulation, or rates (see criterion (A)(3)(ii)). We believe that applicants must necessarily place and (4) creation of a panel, that includes policy, other conditions favorable to providers, to determine the true cost of education reform or innovation that priority on improving and advancing the literacy skills of students if they are supporting a quality early care and improve student outcomes. For these education system. reasons, we do not believe that extra to adequately address these criteria, and, therefore, do not believe that a A few commenters recommended points should be awarded to adding an invitational priority to the applications that address the separate competitive preference priority focused on literacy is necessary. final notice focusing on the invitational priorities. coordination of preschool services Changes: None. Additionally, States and LEAs may Comment: One commenter determine in partnership the roles (including Head Start services and recommended adding an invitational school libraries can play in advancing services provided under the Individuals priority to support alternative the State’s reform goals. with Disabilities Education Act (IDEA)) governance structures. The commenter Changes: None. in order to ensure that more young children begin school ready to learn. stated that in addition to charter Early Learning schools, mayoral control, gubernatorial Discussion: The Department agrees control, and State control have been Comment: Numerous commenters that expanding access to high-quality effective in reforming public education. expressed concern that the NPP did not early learning programs is a key strategy Discussion: As noted elsewhere, we include a priority for, or otherwise in an overall effort to raise student are adding criterion (F)(2)(v) to give require applicants to address, early achievement, particularly for high-need credit to States that enable LEAs to learning in the context of the four students. We agree that the Race to the operate innovative, autonomous public reform areas. Several commenters Top program should encourage States to schools other than charter schools. highlighted the importance of early increase the quality of existing early Changes: None. childhood education in improving learning programs and expand access to student achievement and closing high-quality early learning programs, Literacy achievement gaps, and some cited particularly for children from low- Comment: Numerous commenters research indicating that the most income families. Therefore, we are recommended that the final notice effective time to intervene to close adding an invitational priority focused include a competitive preference achievement gaps is during the on early learning to this final notice.
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We do not believe that States should transition between preschool and emphasis on the social, emotional, and be required to include an early learning kindergarten.’’ creative development of students. focus in their applications or that States Another commenter stated that efforts to School Climate and Culture should be given competitive preference shift education to address the needs of points for doing so. Nor do we believe Comment: Several commenters the whole child should be part of, and that quality early learning strategies recommended that the final notice fully integrated into, a well-rounded should be required to be part of a State’s include a priority to encourage States to core curriculum of academic plan for turning around struggling implement policies and take actions instruction. Finally, one commenter schools, given that efforts to turn around intended to improve school climate, stated that the proposed priorities struggling schools focus primarily on such as citizenship training, anti- incorrectly omit any reference to improving educational outcomes for bullying, or service learning programs reducing the use of punitive measures students currently enrolled in the that may improve academic in schools, and recommended that the Nation’s persistently lowest-achieving achievement, school attendance, and final notice emphasize the Secretary’s schools. We believe that an invitational graduation rates. One commenter policy on reducing the use of restraints, priority will encourage applicants to recommended adding an invitational seclusion, and corporal punishment. consider how their reform efforts can be priority for States that implement Discussion: We agree that a positive strengthened by focusing on activities evidence-based measures to improve school climate that includes policies that promote school readiness and student discipline, stating that there is and measures to improve discipline can ensure that all children have access to a well-documented link between school contribute to improving academic high-quality early learning programs. safety/school discipline and improved achievement, school attendance, and With regard to the request that States academic outcomes. Several graduation rates. We also agree that it is commenters specifically recommended be required to address the issues that important to address the needs of the that we provide for States to address one commenter stated were necessary whole child and to work in school-wide systems of positive for strengthening the quality of early collaboration with other agencies and behavioral interventions and supports care and education programs, a State community organizations in order to and stated that improving school that chooses to include a focus on early successfully educate the whole child. climate is integral to improving the learning in its application could include Therefore, we are changing priority 6, achievement of the lowest performing activities addressing the educational School-Level Conditions for Reform, students. Another commenter stated needs of young children in its State Innovation, and Learning to include that unless the Department designates reform plan. We note, however, that school climate and school culture as school climate as a top priority, equal to funds could not be used to address examples of areas in which an LEA that of academic improvement, schools could provide flexibility and autonomy issues related to early child care needs, are extremely unlikely to focus on to its schools in order to create absent an educational component, improving school climate. A few conditions for reform, innovation, and because the purpose of Race to the Top commenters recommended encouraging learning. The language in new is for States and LEAs to address States to collect data on school paragraph (vi) of this priority educational reforms. Given the variation environments. Other commenters acknowledges the importance of in State needs and priorities, we do not suggested that States support and creating school climates and cultures believe that it would be appropriate to recognize schools that provide that remove obstacles to, and actively require all applicants to follow the opportunities for students to practice support, student engagement and commenter’s recommendations. their education in real-world situations achievement; the language in new In response to the recommendation to that lead to civic engagement. The paragraph (vii) of the priority focuses on add an invitational priority focusing on commenters stated that States should implementing strategies to effectively the coordination of preschool services, ensure that, in policy and funding engage families and communities in this focus is already included in priority decisions, schools know that they are to supporting the academic success of their 5, P–20 Coordination, Vertical and be honored, as well as held accountable, students. Horizontal Alignment, which for creating a caring, welcoming, safe In addition, we note that the final encourages State reform plans to environment. notice addresses issues of school address how early childhood programs, Other commenters strongly climate and culture in several ways. K–12 schools, postsecondary recommended that the final notice First, invitational priority 4, Expansion institutions, and other State agencies include language that would require and Adaptation of Statewide and community partners will coordinate schools to address the needs of the Longitudinal Data Systems, invites to create a more seamless P–20 route for whole child, including by providing States to include school climate and students. character education; instruction in culture measures in extending and Changes: We have added a new social, emotional, and physical adapting their statewide longitudinal invitational priority 3—Innovations for wellness; civic education and data systems. Consistent with Improving Early Learning Outcomes, engagement; arts education; community- commenters’ examples of school which states, ‘‘The Secretary is based learning; and opportunities for policies and programs to improve particularly interested in applications parent involvement. One commenter school climate, we also have included that include practices, strategies, or stated that it is essential for schools to references to ‘‘service learning’’ and programs to improve educational work in collaboration with health, ‘‘experiential and work-based learning outcomes for high-need students who social, civic, faith-based, business and opportunities’’ in the definition of are young children (pre-kindergarten community organizations in order to increased learning time, as examples of through third grade) by enhancing the successfully educate the whole child. activities that contribute to a well- quality of preschool programs. Of One commenter expressed concern that rounded education. And we have particular interest are proposals that the proposed priorities emphasize math, included in our school intervention support practices that (i) improve school reading, and science at the expense of turnaround and transformation models readiness (including social, emotional, the other core academic subjects and for the persistently lowest-achieving and cognitive); and (ii) improve the argued that there should be an equal schools (see criterion (E)(2) and
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Appendix C) the need to address not prohibit or effectively inhibit as programs under the Workforce students’ social and emotional needs increasing the number of high- Investment Act. and to create healthy school climates performing charter schools in the State Discussion: We agree that there is a and cultures. We do not, therefore, or otherwise restrict student enrollment need to increase efforts to re-engage believe that a new separate priority in charter schools. Criterion (F)(2)(ii) youth who have dropped out of school focusing on school climate and culture considers the extent to which the State and to help students who are off-track is necessary. has laws, statutes, regulations, or to graduate stay in school. We have We acknowledge that positive guidelines regarding how charter school addressed the needs of these students in behavioral interventions and supports, authorizers approve, monitor, hold several ways. First, as noted elsewhere, as well as other systemic programs and accountable, reauthorize, and close we are changing criterion (E)(2) policies that address bullying, student charter schools. Under criterion (regarding States’ plans to enable their harassment, and disciplinary problems, (F)(2)(iii), a State will be evaluated LEAs to implement one of the four are important to consider in ensuring based on the extent to which its charter school intervention models) to include that students have a safe and supportive schools receive equitable funding and a credit-recovery programs and re- environment in which to learn. commensurate share of local, State, and engagement strategies as methods that However, we do not believe it is Federal revenues. Finally, criterion can be used by LEAs to increase high necessary to include this level of detail (F)(2)(iv) addresses the extent to which school graduation rates (see Appendix in this final notice and, therefore, a State provides charter schools with C). Second, we are adding a new decline to make the changes requested funding for facilities, assistance with definition of high-need students and by the commenters. facilities acquisition, access to public including in the definition, among Finally, in response to the comment facilities, the ability to share in bonds others, students who are performing far that the notice does not reference and mill levies, or other supports; and below grade level, those who leave reducing the use of punitive measures, the extent to which a State does not school before receiving a regular high on July 31, 2009, the Secretary impose any facility-related requirements school diploma, and those at risk of not encouraged each State to review its on charter schools that are stricter than graduating with a diploma on time. current policies and guidelines those applied to traditional public Third, as noted in the discussion of regarding the use of restraints and schools. All applicants will be rated priority 4, we are inviting States to seclusion in schools to ensure that every against these criteria, among others. extend and adapt their statewide student is safe and protected and, if longitudinal data systems to include Changes: None. appropriate, develop or revise its data from programs that serve at-risk policies and guidelines. We believe that Dropout Recovery students and from dropout prevention this is the proper approach to programs. Fourth, we are adding a Comment: One commenter expressed addressing this issue, rather than in a reference to horizontal alignment in concern that the NPP did not include notice for a competitive grant program priority 5. Horizontal alignment is the targeted investments for dropout for which all States will not necessarily coordination of services across schools, recovery programs or provide States and apply or receive funding. It would be State agencies, and community partners, LEAs with direction on innovative appropriate for States that choose to and we note that it is important in models to re-engage youth who have address priority 6 to include, in their ensuring that high-need students have dropped out of school. The commenter reform plans, a focus on ensuring that access to the broad array of stated that the recovery of high school policies and guidelines address the use opportunities and services they need dropouts must be a central component of restraints and seclusions in schools to and that are beyond the capacity of a of any serious systemic school reform ensure that every student is safe and school itself to provide. We also note effort. Several commenters stated that it protected. that priority 6, School-Level Conditions Changes: We have revised priority 6 is important to recognize that students for Reform, Innovation, and Learning, to include as examples of the who fail to thrive in traditional settings specifically refers to the need to provide autonomies and flexibilities a State’s need additional supports to graduate comprehensive services to high-need participating LEAs may provide to its from high school and that, without students (see paragraph (v)). Therefore, schools: Creating school climates and strategic approaches that intentionally we believe that this final notice cultures that remove obstacles to, and include re-engagement efforts, districts adequately addresses the needs of actively support, student engagement will not serve this population students off-track to graduate who are and achievement and implementing effectively. still in school and those who have strategies to effectively engage families Another commenter recommended disengaged from school and dropped and communities in supporting the that the final notice include a out, and that it is unnecessary to add a academic success of their students. competitive preference priority for competitive preference priority focused serving students who are still in school, on these specific youth. Charter Schools but are off-track to graduate and those With regard to the comment that the Comment: Several commenters who have disengaged from school and final notice encourage coordinating recommended that the final notice dropped out. The commenter noted that ARRA funding with other funding include an absolute priority requiring educational continuity and stability are streams, we believe this issue is States to expand charter schools. also needed for children in foster care. addressed in criterion (A)(2)(i)(d), Discussion: We do not believe an One commenter recommended which will evaluate the extent to which absolute priority for charter schools is establishing a competitive preference a State has the capacity to use Race to necessary because States already will be priority for applicants that include data- the Top funds, as described in the evaluated against criteria that support driven strategies to re-engage high- State’s budget and budget narrative, to the development of high-quality charter school students who fail to graduate on accomplish the State’s plan and meet its schools. Criterion (F)(2) focuses on time and recommended that the final targets, including, where feasible, by charter schools. Specifically, criterion notice encourage States to coordinate coordinating, reallocating, or (F)(2)(i) considers the extent to which a Race to the Top funding with funding ‘‘repurposing’’ education funds from State has a charter school law that does they receive through other sources such other Federal, State, and local sources to
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align with the State’s Race to the Top highly effective teachers teaching in curriculum, instruction, assessments, goals. hard-to-staff subjects and specialty and professional development. Changes: None. areas, such as special education and Furthermore, criteria (B)(3), (C)(3)(ii), (D)(2)(iv)(a), and (D)(5) explicitly focus Students With Disabilities and English language instruction educational on professional development. Criterion Language Learners programs (as defined under Title III of the ESEA). In addition, the measures (B)(3) focuses on, among other activities, Comment: One commenter used to document increases in professional development to support the encouraged the Department to add achievement, closing achievement gaps, transition to new standards and invitational priorities that focus on and increasing graduation rates, all assessments; as noted elsewhere, policy development and require data to be disaggregated by criterion (C)(3)(ii) has been added to implementation (versus data collection subgroups, including the students with focus on professional development for and analysis) for special education and disabilities and limited English teachers, principals and administrators English language acquisition, including proficient students subgroups (see on using instructional improvement the development of high-quality and criteria (A)(1)(iii) and (A)(3)(ii)). systems to support continuous innovative programs of teacher Therefore, we believe that this final instructional improvement; criterion preparation and professional notice ensures that students with (D)(2)(iv)(a) refers to using teacher and development in these areas, in order to disabilities and English language principal evaluations to inform relevant encourage States to meet the needs of learners are not overlooked in State professional development; and criterion students with disabilities and English reform plans and that it is unnecessary (D)(5) focuses on the need for States and language learners more effectively. to add an invitational priority focused LEAs to provide effective data-informed Another commenter expressed on students with disabilities and professional development, coaching, disappointment that the priorities did English language learners. induction, and common planning and not thoroughly take into account the Changes: None. collaboration time to teachers and needs of English language learners. One principals that are, where appropriate, commenter strongly urged the Curriculum, Instruction, Assessments, ongoing and job-embedded. Department to ensure that English Professional Development Changes: None. language learners are not overlooked in State plans, but are explicitly identified Comment: One commenter stated that Research-Based Practice in all areas, including through efforts to the proposed priorities have little to do Comment: One commenter improve standards and assessments, with improving curriculum, instruction, recommended adding an invitational close achievement gaps, increase assessments, or professional priority to encourage States to adopt graduation rates, and ensure college development and recommended that in programs that have been demonstrated readiness. the final notice, the Department give to be effective through rigorous Discussion: The needs of students priority to developing and research. The commenter stated that with disabilities and English language implementing core school improvement priority should be given to States that learners are addressed in many of the activities, particularly school-based identify resources to help their LEAs selection criteria and are especially collaborative activities to improve select programs that are supported by highlighted everywhere the term high- teaching. the best available empirical evidence. need student is used; the new definition Discussion: We disagree with the Discussion: Criterion (A)(2)(i)(b) will of this term includes students with commenter’s statement that the be used to judge the extent to which a disabilities and English language proposed priorities have little to do with State has the capacity to support its learners. All applicants for Race to the improving curriculum, instruction, participating LEAs in successfully Top grants will need to consider how assessments, or professional implementing the education reform they currently work to meet or plan to development. In order to receive a Race plans the State has proposed through meet the unique needs of these students to the Top grant, States must such activities as identifying promising based on the criteria set forth in this demonstrate that they have made and practices, evaluating these practices’ final notice. will continue to drive significant effectiveness, and ceasing ineffective In addition, this final notice improvement in student outcomes, practices. In addition, criteria (C)(2) and recognizes and specifically references including making substantial gains in (C)(3) focus on gathering and using data the unique needs of students with student achievement, closing to support continuous improvement, disabilities and English language achievement gaps, improving high including a specific focus on making the learners in the following areas: (a) school graduation rates, and ensuring data available and accessible to Priority 4 encourages State plans to that students are prepared for success in researchers to evaluate the effectiveness expand statewide longitudinal data college and careers. To accomplish this, of instructional materials, strategies, and systems to include or integrate data a State would have to focus on approaches. We believe these criteria from special education and English improving curriculum, instruction, address the commenter’s concerns and, language learner programs; (b) criterion assessments, and professional therefore, that it is unnecessary to add (C)(3)(iii) will be used to assess the development. Furthermore, absolute the invitational priority suggested by the extent to which States make their data priority 1 requires all applicants to commenter. systems available and accessible to address comprehensively each of the Changes: None. researchers so that they have four education reform areas specified in information to evaluate the effectiveness the ARRA—enhancing standards and Using Data To Inform Practice of instructional materials, strategies, and assessments, improving the collection Comment: One commenter urged the approaches for educating different types and use of data, increasing teacher Department to add a competitive of students, such as students with effectiveness and achieving equity in preference priority for establishing an disabilities and English language teacher distribution, and turning around ‘‘evidence-based learning cycle’’ to learners; and (c) criterion (D)(3) will be struggling schools. In addressing each of improve system-wide policy and used to examine States’ plans to these reform areas, States will student achievement results. The increase the number and percentage of necessarily have to focus on improving commenter recommended that the
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competitive preference priority Discussion: We agree that flexibility As noted elsewhere, we are adding to encourage States to: (1) Design robust in operating conditions is an important this final notice a new section (A), State formative and summative evaluations strategy to facilitate reform efforts. That Success Factors. We are revising a on their Race to the Top programs; is why we included priority 6, School- number of the selection criteria from (2) gather data on the highest-priority Level Conditions for Reform, proposed section (E) (Overall Selection teacher and principal actions, and Innovation, and Learning, which Criteria) and including them as State school-level and classroom-level focuses on flexibilities and autonomies Success Factors Criteria (A). The practices that differentiate fast- that an LEA provides to its schools in purpose of this change is to provide improving schools and classrooms from order to create the conditions for reform, States with the opportunity to begin other schools and classrooms; and innovation, and learning. their proposals with clear statements of (3) document these practices so that Changes: None. their integrated, coordinated, statewide other teachers, school leaders, and State Priority 1: Absolute Priority— reform agendas. In order to be consistent and local policymakers can access and Comprehensive Approach to Education with this change, we are changing the use these tools and evidence to drive a Reform: language in priority 1 to provide that, in continuous cycle of improvement in General Comments addition to addressing the four other schools, classrooms, and systems. education reform areas, State Comment: Numerous commenters applications also must address the State Another commenter recommended expressed support for absolute priority adding the development of longitudinal Success Factors Criteria. Consistent 1 and its focus on ensuring that States with this focus on the State Success data systems as a competitive preference comprehensively address each of the priority in order to accelerate Factors Criteria, we are adding four education reform areas and take a clarifying language and removing the development and implementation of systemic approach to education reform. next-generation, user-oriented data reference to the four reform areas in the The commenters stated that this title of absolute priority 1. systems that provide timely, useful data approach will encourage school systems for teachers and principals to use in With regard to the use of NAEP scores around the country to implement much- to measure increasing student managing performance and improving needed changes that will improve student achievement; prioritize achievement, we are removing this student outcomes. One commenter reference in priority 1 because, as noted academic data with an emphasis on stated that this approach sets a much leading predictive indicators; include elsewhere, the new section on State higher bar for State applications than is Success Factors describes how increases routine data inquiry processes and typically required of competitive grant training to support educators in the in student achievement and closing programs and was supportive of this achievement gaps across subgroups will effective interpretation and use of data approach. Another commenter be measured. State Success Factors that result in improved student encouraged the Department to award Criteria (A)(1)(iii) and (A)(3)(ii) specify achievement; and enhance State and Race to the Top grants only to those that when evaluating increases in local capacity to use data and improve States that pursue significant student achievement and gap-closing, the systematic integration and use of comprehensive and systemic reforms. reviewers will examine results in data over time. However, one commenter expressed reading/language arts and mathematics Discussion: The evidence-based concern that this approach would based on the NAEP and on the learning cycle and the user-oriented encourage States to lower standards assessments required under the ESEA. data systems proposed by the rather than provide incentives for States Changes: Absolute priority 1 has been commenters are similar in concept to to improve their educational standards revised to read: ‘‘To meet this priority, criteria (C)(2) and (C)(3). Criteria (C)(2) and put in place the reforms necessary the State’s application must and (C)(3) focus on the use of data from to improve educational outcomes. comprehensively and coherently the State’s statewide longitudinal data Discussion: We appreciate the support address all of the four education reform system and the local instructional for absolute priority 1 and its focus on areas specified in the ARRA as well as improvement systems to support a comprehensive and systematic the State Success Factors Criteria in continuous improvement both within approach to addressing the four order to demonstrate that the State and and outside of the classroom. In education reform areas specified in the its participating LEAs are taking a addition, priority 4 focuses on ARRA. We do not agree with the systemic approach to education reform. expanding statewide longitudinal data commenter that a comprehensive and The State must demonstrate in its systems to include or integrate data systematic approach to the four reform application sufficient LEA participation from a variety of sources, including, for areas will encourage States to lower and commitment to successfully example, human resources, school standards. The focus on improving implement and achieve the goals in its finance, and other relevant areas with student achievement, decreasing plans; and it must describe how the the purpose of connecting and achievement gaps, and increasing high State, in collaboration with its coordinating all parts of the system to school graduation rates, and the use of participating LEAs, will use Race to the inform continuous improvement sound measures, such as the results Top and other funds to increase student practices. Therefore, we do not believe from the NAEP, will help ensure that achievement, decrease the achievement it is necessary to make the changes States do not lower their standards. In gaps across student subgroups, and recommended by the commenters. addition, unlike in other competitive increase the rates at which students Changes: None. programs, we are rewarding States that graduate from high school prepared for have already created the conditions for Flexibility in Operating Conditions college and careers.’’ reform and improved student outcomes Competitive Preference Priority 2: Comment: One commenter and have a strong foundation for Emphasis on Science, Technology, recommended that the Department implementing plans going forward. Engineering, and Mathematics (STEM): include an invitational priority for States that have lowered their standards Comment: Numerous commenters applicants that commit to implementing will not clear the high bar that we have expressed support for including an the reforms and providing flexible set for awards under the Race to the Top emphasis on STEM education as a operating conditions for their schools. program. competitive preference priority. The
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commenters noted that major relevant instruction in those fields, and public broadcasting entities. One developments in medicine, energy, and prepare more students for advanced commenter strongly recommended that agriculture are dependent on study and careers in STEM. While we the Department provide guidelines for innovations in STEM fields and stated believe increasing the focus on STEM selecting STEM-capable partners. that engaging students in STEM education is important, we do not Another commenter noted that non- education programs is the most effective believe that an emphasis on STEM school settings, such as museums and way to improve the Nation’s economy education should be required as part of science centers, offer designed spaces and maintain America’s global the core work that States are required to and programs to engage students and leadership. One commenter address in their reform plans for the encourage them to pursue and develop recommended changing the priority to Race to the Top program. Therefore, we interests in scientific inquiry that may an absolute priority and another decline to change the emphasis on positively influence academic commenter recommended adding STEM education to an absolute priority achievement and expand students’ selection criteria related to STEM or include selection criteria sense of career options. education. emphasizing STEM education. With Discussion: To meet priority 2, However, many commenters stated regard to commenters’ concerns that applicants must cooperate with industry that designating STEM as a competitive emphasizing STEM education might experts, museums, universities, research preference priority implies that STEM encourage STEM-only programs, as centers, or other STEM-capable subjects are more important than other opposed to STEM-focused programs, we community partners in preparing and subjects and recommended omitting or note that this notice specifically refers assisting teachers to integrate STEM changing the STEM priority to an to preparing and assisting teachers in content across grades and disciplines, to invitational priority. One commenter integrating STEM content across grades promote effective and relevant asked why the Department chose to and disciplines. The priority will not instruction, and to offer applied emphasize STEM subjects over other prohibit States from using data from learning opportunities for students. We subjects. areas other than STEM education to do not believe it is appropriate to be Numerous commenters expressed drive reform, nor should it discourage more specific about the STEM-capable concern that including a competitive them from doing so. partnerships that States should form preference priority on STEM education Changes: None. given that the resources and needs vary would lead to a narrowing of the Comment: Two commenters considerably across schools and curriculum. One commenter expressed recommended that the final notice communities; such decisions are best concern that a competitive preference clarify the meaning of ‘‘a rigorous left to local decision makers. Therefore, priority emphasizing STEM education course of study,’’ as used in priority 2, we decline to include additional might encourage STEM-only programs, by providing examples of what the examples of STEM-capable partnerships as opposed to STEM-focused programs Department considers to be rigorous or to provide guidelines for selecting in which the content is integrated into courses of study. The commenters STEM-capable partners, as requested by various curricular areas. The commenter suggested Advanced Placement courses commenters. expressed concern that the priority and STEM-intensive courses, such as would prohibit States from applying those offered in many career and Changes: None. data-driven reform and school technical education programs, as Comment: One commenter achievement interventions that do not examples of rigorous courses of study. recommended that the Department focus on STEM. Another commenter One commenter recommended revise priority 2 to explicitly include recommended changing the priority to including a reference to career computer science as part of STEM give States the option of using data to preparatory coursework. Two education. The commenter stated that develop plans that meet the needs of commenters recommended the final computer science is often confused with their low-performing schools. notice include an incentive for States technology literacy and this confusion Discussion: We appreciate the support that assess the alignment of rigorous leads to teaching basic skills instead of expressed for including a competitive courses of study in STEM subjects with core concepts and problem solving. The preference priority on STEM education. other courses of study in a school’s commenter noted that computer science Ensuring American competitiveness in a curriculum. provides students with a fundamental global economy requires significant Discussion: The Department believes understanding of computing, exposure improvements in STEM education. As that States should have the flexibility to to professional fields, and opportunities the commenters noted, professionals in determine the content and focus of a to develop computational thinking STEM fields are major contributors to rigorous course of study in STEM skills. the American economy in such areas as subjects and, therefore, declines to add Discussion: STEM education includes medicine, agriculture, and energy. examples of rigorous courses of study in a wide-range of disciplines, including Science-based industries are in need of priority 2. In determining the rigor of a computer science. We believe that skilled workers, and we believe a course in STEM subjects, local decision- States should have the flexibility to competitive preference priority on makers will likely assess how STEM define the specific courses of study in STEM will help schools produce a subjects are integrated and aligned with mathematics, the sciences, technology, generation of Americans who can meet other courses offered in a State or LEAs’ and engineering, based on the needs and this demand. Therefore, we decline to current programs of study. Therefore, available resources of the State, as well eliminate priority 2 or to re-designate we do not believe that it is necessary to as the advice of industry experts, priority 2 as an invitational priority. We provide incentives for doing so. museums, universities, research centers, did not intend for an emphasis on Changes: None. and other STEM-capable community STEM education to result in a Comment: A few commenters partners. Therefore, we decline to narrowing of the curriculum. Rather, recommended that the final priority change priority 2 to specify that our intent was to focus attention on the reference additional STEM-capable computer science is a part of STEM need to develop and implement rigorous community partners such as youth- education, as requested by the courses of study in STEM fields, assist serving community organizations, commenter. teachers in providing effective and ‘‘valued-added intermediaries,’’ and Changes: None.
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Comment: One commenter provide alternative pathways for STEM Discussion: With regard to the recommended that the Department professionals to join the teaching force commenter’s recommendation that the require States to implement the as full-time teachers, co-teachers, or Department encourage States to provide recommendations of the National professional development providers. high-level STEM curricula to advanced Mathematics Advisory Panel regarding The commenters noted that STEM students in earlier grades than is typical, K–8 mathematics teacher preparation professionals in the classroom would States will have opportunities to programs and licensing requirements. help students understand the career include such concepts in their The commenter stated that teacher opportunities available for individuals applications, if they so desire, through preparation programs and licensing with knowledge in STEM subjects. One priority 6, which focuses on LEAs requirements for K–8 mathematics commenter recommended providing creating the conditions for reform and teachers should address arithmetic, additional credit to States that use innovation by providing their schools geometry, measurement, and algebra. ‘‘informal science education centers’’ as with flexibilities and autonomies; Another commenter recommended resources for professional development. through criterion (B)(3), which requiring States to provide funds for Discussion: We agree with addresses instructional issues relating to improving State licensing requirements commenters that efforts should be made enhanced standards; and by addressing in order to ensure that K–8 teachers to recruit and train STEM professionals competitive preference priority 2, which master core mathematics content. One to join the teaching force as teachers and focuses on STEM education. commenter recommended that the that having such professionals in the Changes: None. Department require in-service training classroom would help students Comment: One commenter urged the for K–8 mathematics teachers. Another understand the career opportunities Secretary to encourage States to open commenter recommended that the available in STEM fields. Criterion statewide, public, residential high Department revise priority 2 in order to (D)(1), which assesses the extent to schools that focus on math and science. ensure that teachers in high-risk, low- which a State has high-quality pathways Discussion: To the extent that a public performing schools are provided with for aspiring teachers and principals, residential high school would be professional development opportunities, addresses this concern. To the extent considered an innovative school, we mentoring, and the necessary guidance that the informal science education note that criterion (F)(2)(v) encourages to ensure that rigorous courses of study centers, referred to by one commenter, States to enable LEAs to operate such in STEM subjects are taught in these provide professional development as an innovative, autonomous public schools. schools. alternative route to certification, States Therefore, we do not believe that Discussion: We do not believe that it that permit use of such centers would be additional language in priority 2 is would be appropriate for the given credit under criterion (D)(1)(i). needed to address the commenter’s Department to require States to Therefore, we decline to give additional recommendation. implement the recommendations of the credit to States that use such centers as Changes: None. Comment: One commenter stated that National Mathematics Advisory Panel recommended by one commenter. regarding mathematics teacher the availability of up-to-date laboratory Changes: None. preparation programs and licensing equipment plays an important role in Comment: One commenter requirements; decisions regarding STEM learning and requested that the recommended that the Department teacher preparation programs and Department clarify whether Race to the licensing requirements are best left to invite States to strengthen their early Top funds could be used to purchase State and local officials to make childhood education programs by laboratory equipment and technological depending on the unique needs and including STEM education in their State tools to implement STEM programs. The circumstances in each State. With reform plans for early learning commenter stated that the quality and regard to the recommendation to require programs. quantity of equipment is inadequate in in-service training and professional Discussion: As noted elsewhere, we most schools, particularly in schools development, mentoring, and guidance are adding an invitational priority for with high concentrations of at-risk in STEM subjects to teachers in high- early learning programs (see priority 3), students. risk, low-achieving schools, we note which includes a focus on improving Discussion: The Race to the Top that this final notice includes several young children’s school readiness, and program provides States and LEAs with criteria that address the professional a competitive preference priority for significant freedom to use Race to the development needs of teachers, STEM education (see priority 2). States Top funds to meet the goals outlined in including criteria (B)(3), (C)(3)(ii), that choose to address either of these their State reform plans. Laboratory (D)(2)(iv)(a), and especially (D)(5), priorities could include a description of equipment would be an allowable use of which focuses on the extent to which efforts to ensure that early learning funds under the Race to the Top States provide effective support to program standards and curricula program. teachers and principals. We believe that include developmentally appropriate Changes: None. these criteria adequately address the science, pre-numeracy, and numeracy Comment: One commenter urged the commenter’s concerns regarding content in order to help prepare young Department to encourage States to professional development; States children to succeed in STEM-related develop a common set of core STEM addressing the STEM competitive areas when they enter school. standards and assessments. In addition, preference priority will have ample Changes: None. the commenter recommended that the opportunities to address professional Comment: One commenter Department encourage and reward development needs in their responses to recommended that the Department States that enhance their high school these criteria. We therefore decline to encourage States to provide high-level graduation requirements to include four change priority 2 in the manner STEM curricula to advanced students in years of STEM courses. recommended by the commenter. earlier grades than is typically the norm. Discussion: The Department is Changes: None. The commenter noted that local policies encouraging States to develop a Comment: A few commenters and practices typically inhibit common set of high-quality K–12 recommended that the Department acceleration options and leave advanced standards that are internationally encourage States to recruit, train, and students unchallenged. benchmarked and that build toward
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college- and career-readiness by the the Department reiterate that recipients high-quality STEM courses and time of high school graduation. In of Race to the Top funds should remove instructors, remediation for low- addition, the Department is encouraging obstacles that might discourage female performing students through interactive States to develop and implement students from enrolling and completing instructional software, virtual field common, high-quality assessments that STEM programs. trips, and online connections to STEM are aligned with those standards. Thus, Discussion: We agree with these professionals. criterion (B)(1) assesses the extent to commenters that all students should Another commenter noted that which a State has demonstrated its have access to rigorous courses of study programs supported by universities use commitment to adopting a common set in STEM programs. Paragraph (iii) in technology and multimedia to improve of high-quality standards, and criterion priority 2 specifically refers to State teaching and learning of STEM subjects (B)(2) assesses the extent to which the plans addressing the needs of and recommended that universities and State has demonstrated its commitment underrepresented groups and of women the business sector work in partnership to improving the quality of its and girls in the areas of science, with schools to prepare students for assessments. It is a State’s responsibility technology, engineering, and postsecondary education and workplace to determine the content of those mathematics. Therefore, we do not success. standards and assessments, including believe that additional language needs Discussion: We agree that the whether to develop a common set of to be added to priority 2 to address the approaches that commenters discussed core STEM standards and assessments. commenters’ concerns. can be useful in implementing STEM Likewise, States are responsible for Changes: None. programs. However, we believe such Comment: Two commenters establishing high school graduation decisions are best left to local officials recommended that the final notice requirements. Thus, whether or not four who understand the needs and available reference advanced laboratory work, years of STEM courses are included as resources in their schools and service learning, project-based learning, a requirement for graduation from high communities. We decline, therefore, to and work-based learning as examples of school is a decision that is made by make the changes that the commenters ‘‘applied learning opportunities.’’ The States, not the Federal Government. recommend. commenters stated that providing such Changes: None. Changes: None. Comment: Several commenters examples would help clarify the recommended that the Department meaning of applied learning Comment: One commenter asked how require STEM instruction to be opportunities as it is used in priority 2. the Department will determine whether consistent with the principles of One commenter recommended that the a State’s application meets the universal design for learning. The Department clarify that applied learning competitive preference priority. The commenters noted that universal design opportunities could occur during commenter asked specifically whether a for learning is defined in section 103(24) regular school hours, or before or after ‘‘pilot’’ project focused on STEM of the Higher Education Opportunity the regular school day. education, rather than a comprehensive Act of 2008 (Pub. L. 110–315), as a Discussion: A State seeking to meet STEM program, would meet priority 2. structure that provides flexibility in priority 2 is required to cooperate with Another commenter recommended that instruction that accommodates, industry experts, museums, universities, the Department require a State’s supports, and maintains high research centers, and other STEM- proposed STEM programs to be achievement expectations for all capable community partners to ensure evidence-based. students, including students with that instruction is relevant and that Discussion: Priority 2 describes the disabilities and English language students are provided with three elements that a State’s reform plan learners. opportunities to apply what they have must address to meet priority 2. These Discussion: Paragraph (ii) in priority 2 learned in the classroom. Such elements include the need to (i) offer a focuses on promoting STEM education cooperative work with experts in STEM rigorous course of study in STEM that is effective, relevant, and includes fields should provide a State with ample subjects; (ii) cooperate with industry applied learning opportunities for examples of applied learning experts, museums, universities, research students. To the extent that such opportunities. In addition, as noted centers, or other STEM-capable instruction can be provided consistent elsewhere, we are adding a definition of community partners to prepare and with the principles of universal design, increased learning time; this definition assist teachers in integrating STEM we encourage States to do so. However, specifically references service learning content across grades and disciplines, in we do not believe it would be and experiential and work-based promoting effective and relevant appropriate to require all instruction to learning and encourages such learning instruction, and in offering applied be consistent with the principles of to occur during or outside of regular learning opportunities; and (iii) prepare universal design for learning as school hours. As such, we do not more students for advanced study and recommended by the commenters. believe it is necessary to include careers in science, technology, Changes: None. examples of applied learning engineering, and mathematics, Comment: A few commenters opportunities in priority 2, which could including by addressing the needs of recommended that the Department limit, rather than promote ideas and underrepresented groups and of women promote racial, economic, and gender strategies to improve or enhance STEM and girls in STEM areas. We are integration in STEM programs. These education programs. clarifying that, to meet the priority, the commenters stated that programs Changes: None. State’s application must have a high- funded by the Department have an Comment: One commenter quality plan to address each of these obligation to be inclusive and remove recommended that priority 2 be changed elements. We do not believe it is discriminatory barriers. One commenter to require State reform plans to describe necessary to require that a State’s noted that STEM programs should be how technology will be incorporated as proposed STEM program be evidence- included in schools that serve low- a required component in STEM based in order to meet this priority; income students to ensure that such education programs. The commenter reviewers will judge the quality of the students have access to STEM programs. also recommended requiring State program that a State proposes, which Another commenter recommended that reform plans to include online access to will necessarily include the extent to
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which the State’s proposed STEM Changes: None. 12 elements of the America COMPETES education program is evidence-based. Comment: One commenter Act to connect their statewide Changes: We have revised the priority recommended that priority 4 be longitudinal data systems to other data to specify that, to meet this priority, the eliminated. The commenter stated that or data systems that may exist State’s application must have a high- Race to the Top funds should be used independently from a State’s statewide quality plan to address the areas to improve teaching and not for longitudinal data system. The specified in the priority. expanding data systems. information that will be responsive to Comment: One commenter stated that Discussion: Establishing a statewide this priority will depend on each State’s a significant investment is necessary to longitudinal data system that provides current statewide longitudinal data successfully improve student data on student achievement or student system, the extent to which it is already performance in STEM subjects and growth to teachers and principals, as connected to other data or data systems, recommended that the Department well as policymakers, researchers, and and the types of questions related to revise priority 2 to provide a preference other stakeholders, is key to driving policy, practice, or overall effectiveness to States with the infrastructure to education reform in general, and that a State needs to answer in order to demonstrate results. improvements in the classroom, in implement its reform agenda. We Discussion: We do not believe that particular. Therefore, we decline to believe that this purpose could have preference should be given to States that eliminate priority 4. been stated more clearly in the priority already have the infrastructure in place Changes: None. and, therefore, are adding clarifying to evaluate and demonstrate results. As Comment: Several commenters language. part of its application, each State must recommended that priority 4 be changed Changes: We have changed the end of provide a detailed budget and from an invitational priority to a the last sentence in the first paragraph accompanying budget narrative competitive preference priority because of the priority as follows: ‘‘* * * with describing how the State plans to use of the importance of linking data from the purpose of connecting and Race to the Top funds to accomplish the various program areas with statewide coordinating all parts of the system to State’s reform plan and meet its targets. longitudinal data systems. Several allow important questions related to The detailed plan for using grant funds commenters stated that expanding and policy, practice, or overall effectiveness must include, among other things, the linking data systems are essential to to be asked, answered, and incorporated key goals, the key activities to be achieving comprehensive reform in the into effective continuous improvement undertaken, the rationale for the four ARRA education reform areas, and practices.’’ activities, and the timeline for therefore, recommended changing the Comment: One commenter noted that implementing the activities (see priority to an absolute priority. statewide longitudinal data systems application requirements). A State that Discussion: We believe that priority 4 could be expanded in a number of ways includes a focus on STEM education is appropriately designated as an such as including additional data from must, therefore, include in its proposed invitational priority because it extends within the agency, from other State budget how it plans to use grant funds the work that States are already doing to agencies, from other States, or from or other Federal, State, and local funds address the criteria related to fully management systems that track and to meet its goals related to improving implementing statewide longitudinal allocate resources. The commenter STEM education. data systems. A State will already be recommended that the priority include Changes: None. judged on the extent to which it has a this clarification. Another commenter Priority 4—Invitational Priority— statewide longitudinal data system that recommended that the priority Expansion and Adaptation of Statewide includes all of the America COMPETES encourage States to link their Longitudinal Data Systems (Proposed Act elements (see criterion (C)(1)) and longitudinal data systems with data Priority 3): the extent to which it has a high-quality from other State agencies. Comment: A number of comments plan to ensure that data from the State’s Discussion: While the commenter were received on priority 4 that were statewide longitudinal data system are noted several ways in which statewide similar to the comments received on used to support decision-makers in the longitudinal data systems could be criterion (C)(1), regarding implementing continuous improvement of policy, expanded, we do not believe that it is a statewide longitudinal data system; instruction, operations, management, necessary to include this information in criterion (C)(2), regarding accessing and resource allocation, and overall the priority, nor to encourage States to using State data; and criterion (C)(3), effectiveness (see criterion (C)(2)). While link their longitudinal data systems regarding using data to improve we believe that the focus of priority 4 with data from other agencies. How instruction. is important, it is not part of the core States expand their data systems will Discussion: In some cases we have work that States must do to address the depend on the current needs, resources, responded to comments received in four education reform areas. Therefore, and capabilities of each State’s response to priority 4 under section (C), we decline to re-designate priority 4 as statewide longitudinal data system. We Data Systems to Support Instruction. an absolute priority or as a competitive remind States that they must consider This enabled us to group similar preference priority. how to protect student privacy as data comments and concerns in order to be Changes: None. are shared across agencies. Successful more responsive to the commenters. Comment: One commenter requested applicants that receive Race to the Top Changes: None. clarification about the data that are grant awards will need to comply with Comment: One commenter required to meet this priority and the the Family Educational Rights and recommended changing the title of this questions these data should be able to Privacy Act (FERPA), including 34 CFR priority to ‘‘Expansion, Adaptation, and answer. Part 99, as well as State and local Appropriate Utilization of State Discussion: Criterion (C)(1) will requirements regarding privacy. Longitudinal Data Systems.’’ examine the extent to which a State has Changes: None. Discussion: We do not believe the a statewide longitudinal data system Comment: Many commenters lengthier title recommended by the that includes all of the America recommended that statewide commenter is necessary, and therefore, COMPETES Act. The purpose of priority longitudinal data systems include decline to change the title of priority 4. 4 is to reward States that go beyond the student-level data on transfers, chronic
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absenteeism, and in- and out-of-school Comment: Two commenters commenters stated that such suspensions, as well as school dropout recommended that statewide ‘‘horizontal’’ alignment is just as rates, dropout and re-enrollment data, longitudinal data systems include data important as ‘‘vertical alignment,’’ and data on students completing P–16 on all postsecondary students, including particularly for high-need students. One programs. One commenter adults who are enrolled part-time, commenter recommended that the recommended that data on ‘‘student taking non-credit courses, or Department require State reform plans mobility’’ be included in all data participating in remedial programs. to provide information about how all gathering and reporting. Other These commenters also recommended parts of the State’s education system commenters strongly recommended that that statewide longitudinal data systems will work to improve student State longitudinal data systems include include data on participants in other achievement and the overall quality of measures of school safety, culture, and educational and workforce training schools, and how the State’s education climate. programs such as adult basic education system will work with other supporting Discussion: Applicants for Race to the programs. Several commenters agencies and institutions to address the Top grants will already be judged on the recommended referencing data on needs of all students. The commenter extent to which the State has a career placements and State also recommended that State reform statewide longitudinal data system that employment wage records as areas in plans address how the improvement includes all of the America COMPETES which States should expand their process will be managed effectively both Act elements (see criterion (C)(1)). systems. within the educational system and Those elements include, among other, Discussion: As priority 4 already across supporting agencies and student level enrollment, demographic, references postsecondary data, we do institutions. and program participation information; not believe it is necessary to add Numerous commenters stated that and student-level information about the specific detail about the types of community-based organizations play a points at which students exit, transfer postsecondary data that States should key role in assisting youth at the in, transfer out, dropout, or complete collect. Nor do we believe that it is secondary level, particularly in helping P–16 education programs. It would not, necessary to reference data on career them transition to postsecondary therefore, be appropriate to include placements and State employment wage education, and therefore, should be these elements in priority 4, which is records. States that believe such data are included as partners in creating a focused on expanding statewide important to their overall reform seamless P–20 route for students. A few longitudinal data systems. However, we strategy can certainly propose to expand commenters stated that the educational believe that it is appropriate to reference their statewide longitudinal data base by system should work with child welfare, in priority 4 linking data from at-risk adding these elements. juvenile justice, and criminal justice and dropout prevention programs, Changes: None. agencies to help re-engage high school Comment: Two commenters referred school climate and culture programs, dropouts. to the statement in the proposed priority Discussion: We agree that priority 5 and information on student mobility. stating that the Secretary was interested would be strengthened by including a Such data will complement and expand in applications in which States propose focus on coordinating educational the data that States will be collecting working together to adapt statewide systems with other State agencies and through the America COMPETES Act longitudinal data systems, rather than community organizations that provide elements. Therefore, we are adding having each State build such systems services to students that are beyond the language to the priority to refer to at-risk independently. The commenters capacity of schools to provide. This and dropout prevention programs, requested guidance on how States would include, for example, school climate and culture programs, should work together and asked for community-based organizations that and information on student mobility. clarity about whether one State should serve youth, as well as child welfare, For clarity, we also are adding a be designated as the lead and what juvenile justice, and criminal justice parenthetical following ‘‘human would happen if only one of the States agencies, as mentioned by commenters. resources.’’ in the partnership is successful in Therefore, we are revising the priority, Changes: We have added the phrase receiving a Race to the Top award. as well as the title of the priority, to ‘‘at-risk and dropout prevention Discussion: States that propose to reflect a focus on the ‘‘horizontal programs, and school climate and work together to adapt their statewide alignment’’ of the educational system culture programs, as well as information longitudinal data systems should with other agencies and community on student mobility’’ following ‘‘early include these proposed efforts in their organizations. Applicants that choose to childhood programs’’ in priority 4. We reform plan and show how these efforts address priority 5 should include in also have added ‘‘(i.e., information on are coordinated with the State’s larger their State reform plans how all parts of teachers, principals, and other staff)’’ reform efforts. When developing their the education system will coordinate following ‘‘human resources.’’ plans, States should propose alternative their work to create a more seamless Comment: None. options should one of the States not be P–20 route for students—both vertically, Discussion: Throughout this notice, awarded Race to the Top funds and be to ensure that students exiting one level we have used the term ‘‘English unable to devote other funds to achieve of the education system are prepared for language learner,’’ rather than ‘‘limited the outlined goals. success in the next, as well as English proficient,’’ whenever possible. Changes: None. horizontally, to ensure that services During our internal review, we noted Priority 5—Invitational Priority—P–20 across schools, State agencies, and that we inadvertently used ‘‘limited Coordination, Vertical and Horizontal community partners are coordinated English proficient’’ in priority 4. Alignment (Proposed Priority 4): and aligned. Therefore, we are changing ‘‘limited Comment: Several commenters With regard to the comment that State English proficient,’’ to ‘‘English recommended that priority 5, regarding reform plans address how the language learner’’ in priority 4. P–20 coordination, include an emphasis improvement process will be managed Changes: We have replaced ‘‘limited on aligning a State’s educational system effectively, we note that criterion (A)(2) English proficiency’’ with ‘‘English with other State agencies and focuses on the extent to which States language learner’’ in priority 4. community organizations. The have built strong statewide capacity to
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implement, scale up, and sustain their classroom instruction and help develop programs or to other specific types of proposed reform plans. school-work partnerships. schools or programs. Therefore, we Changes: We have changed the title of Discussion: We agree with the decline to make the changes requested priority 5 to: P–20 Coordination, commenters and are changing by the commenters. Vertical and Horizontal Alignment. In ‘‘workforce organizations’’ to Changes: None. addition we have added ‘‘and other ‘‘workforce development organizations’’ Comment: Many commenters State agencies and community partners to be clear that such organizations are highlighted the importance of (e.g., child welfare, juvenile justice, and important to creating a more seamless improving the transition from early criminal justice agencies)’’ following P–20 route for students. We also are childhood to K–12 programs. One ‘‘organizations’’ in the first sentence of including careers as an example of a commenter asked that States be allowed the priority. Finally, we have added the critical transition point. to focus on coordination between early following sentence at the end of the Changes: We have changed childhood and elementary school priority: ‘‘Horizontal alignment, that is, ‘‘workforce organizations’’ to exclusively and without penalty for coordination of services across schools, ‘‘workforce development excluding middle school, high school, State agencies, and community partners, organizations.’’ In the parenthetical and post-secondary education in their is also important to ensure that high- following ‘‘each point where a transition plans. One commenter recommended need students (as defined in this notice) occurs,’’ we have changed that the Department more explicitly have access to the broad array of ‘‘postsecondary’’ to ‘‘postsecondary/ identify the ways in which early opportunities and services they need careers.’’ childhood and higher education sectors and that are beyond the capacity of the Comment: Two commenters should participate in States’ reform school itself to provide.’’ recommended including family strategies and provide guidance on how Comment: Many commenters engagement in each State’s P–20 plan. cross-system alignment will be recommended changing priority 5 from Discussion: As part of its overall evaluated in the peer review process. an invitational priority to a competitive reform plan, States will be judged on the Two commenters recommended that preference priority, stating that P–20 extent to which they have enlisted SEAs work with State early childhood alignment efforts are key to improving strong statewide support and advisory councils to improve the student transitions, and ultimately, commitment from a broad array of transition from early childhood student success. A few commenters stakeholders, which includes programs to K–12 programs. recommended changing priority 5 from community organizations, such as Discussion: As discussed elsewhere, an invitational priority to an absolute parent-teacher associations. Therefore, we are adding a new invitational priority. One commenter stated that we do not believe it is necessary to add priority 3 on improving early coordination across and within systems family engagement in this priority, as educational outcomes for high-need can improve instruction, service recommended by the commenters. We students who are young children, which delivery, and communication, and thus also note that priority 6 specifically includes a focus on improving create an environment that encourages focuses on flexibilities and autonomies transitions between preschool and innovation. for school-level reform, including those kindergarten. Discussion: We believe that priority 5 related to implementing strategies to With regard to the comment asking is appropriately designated as an effectively engage families and whether States could focus on the invitational priority because it extends communities in supporting the transition between early childhood and beyond the core K–12 focus of the Race academic success of their students (see elementary school exclusively without to the Top program. States will already paragraph (vii) in priority 6). penalty for excluding middle and high be judged on the extent to which they Changes: None. school transitions, and the comment set forth a comprehensive and coherent Comment: One commenter regarding how alignment will be reform agenda for improving student recommended that the reference to evaluated in the peer review process, we outcomes statewide (see criterion (A)(1)) vertical alignment in this priority note that States will be judged on the and the extent to which they enlist include multiple education pathways to extent to which their plans set forth strong statewide support and graduating from high school, such as comprehensive and coherent reform commitment for their plans from a alternative education programs, general agendas for improving student outcomes broad group of stakeholders, which may educational development (GED) statewide (see criterion (A)(1)), and on include other State agencies, nonprofit programs, and community college the extent to which States have enlisted organizations, and community-based programs. Another commenter strong statewide support and organizations (see criterion (A)(2)(ii)). recommended that priority 5 focus on commitment for their plans from a While we believe that the focus of alignment between the traditional broad group of stakeholders, which may priority 5 is important, it is not part of education system and alternative include IHEs and agencies providing the core work that States must do to education programs for high school early childhood education (see criterion address the four education reform areas. dropouts. Two commenters urged the (A)(2)(ii)). States that choose to address Therefore, we decline to re-designate Department to include adult education priority 5 should discuss how to priority 5 as an absolute priority or a programs in this priority, stating that coordinate all parts of their systems to competitive preference priority. adult education programs play a key create more seamless P–20 routes for Changes: None. role in the P–20 route for some students, students—both vertically, to ensure that Comment: Several commenters particularly English language learners. students exiting one level of the recommended that priority 5 encourage Discussion: Priority 5 refers to K–12 education system are prepared for collaboration between K–12 schools, schools, postsecondary institutions, success in the next, and horizontally, to higher education, and workforce workforce development organizations, ensure that services across schools, development organizations in order to and other State agencies and community State agencies and community partners create pathways to college and work. partners, which would encompass the are coordinated and aligned. One commenter stated that partnerships programs referenced by the commenters. The ways in which early childhood with workforce development We do not believe that the notice needs and higher education programs organizations would add relevance to to include additional references to these participate in States’ reform strategies
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will vary from State to State depending an early childhood educational focus from LEAs with outstanding records in on the needs and resources in each starting in pre-kindergarten seems most data development and reporting in order State. Therefore, we decline to include applicable. The Department has other to improve the vertical alignment of the in priority 5 specific ways in which programs that will focus exclusively and State’s education system. these sectors should participate in their comprehensively on children younger Discussion: We agree that longitudinal State’s reform plans, as requested by one than pre-kindergarten age. data could be used to evaluate and commenter. Changes: None. improve the effectiveness of programs We agree that one way to improve Comment: One commenter designed to improve transitions from transitions from early childhood recommended that States include one level of the education system to programs to K–12 programs is for SEAs private schools in developing their another. We also agree that States and to work with State early childhood plans to create a more seamless P–20 LEAs should learn from each other on advisory councils. We are not including route for students. The commenter using data to improve the vertical specific examples of processes the State noted that many students attend both alignment of educational systems. may use to improve transitions across public and private schools at various Priorities 3, 4, and 5 encourage States to the P–20 system; we believe such times in their educational careers. undertake such practices. We note that decisions are best left to local decision- Discussion: There is nothing that States receiving Race to the Top funds, makers. would preclude a State from including along with their LEAs and schools, are Changes: None. in its plan efforts to improve expected to identify and share Comment: Two commenters coordination with private schools. We promising practices, make work freely recommended adding a reference in this note that nothing in the Race to the Top available within and across States, make priority to middle school transitions program requires a State that receives data available in appropriate ways to (i.e., elementary to middle school and funds under Race to the Top to include stakeholders and researchers, and help middle to high school) because these private schools in the four reform areas. all States focus on continuous transitions can be particularly Because the Race to the Top program is improvement of student outcomes. challenging with the increased directed to improving public K–12 Changes: None. expectations for student performance education, we decline to include a Priority 6—Invitational Priority— and responsibility, often in reference to private schools in priority School-Level Conditions for Reform, environments that are far less 5, which addresses a more seamless P– Innovation, and Learning (Proposed personalized than elementary schools. 20 route for students. Priority 5). Discussion: We agree that transitions Changes: None. General: to and from middle school can be Comment: One commenter asked Comment: Numerous commenters challenging. Ensuring smooth whether the focus of priority 5 is on expressed support for priority 6. While transitions from elementary to middle developing a P–20 data system. Another some commenters stated that it was school and from middle school to high commenter asked how the data elements appropriate for priority 6 to be an school would be important aspects of in a P–20 system would differ from a invitational priority, numerous other creating a seamless P–20 route for P–16 system’s required elements. commenters recommended changing students. The fact that priority 5 does Discussion: Priority 5 focuses on priority 6 to a competitive preference not specifically reference the transitions improving all parts of the education priority stating that the conditions listed to and from middle school does not system by coordinating within the for reform and innovation are critical to mean that State reform plans should not educational system (e.g., between early supporting school reform efforts. One include efforts to improve these childhood programs, K–12 schools, commenter stated that it is important to important transitions. We note that the postsecondary institutions) and between give priority to school-level conditions parenthetical in priority 5 provides the educational system and other State for reform because reform is most examples of critical transition points agencies and community partners (e.g., evident when changes are implemented before and after K–12 and is not meant child welfare, juvenile justice, and at the local level, where student to exclude transition points within K–12 criminal justice agencies). Priority 5 is learning can be directly and that States may address within their not focused on P–20 data systems; that immediately influenced. core Race to the Top reform plans. is the focus of priority 4, Expansion and Several commenters urged the Changes: None. Adaptation of Statewide Longitudinal Department to make priority 6 a Comment: A few commenters Data Systems. competitive preference priority in order requested that priority 5 include a Under criterion (C)(1), States will be to ensure that districts create the requirement to coordinate early judged on the extent to which they have preconditions for dramatically childhood programs that serve children a statewide longitudinal data system improving student achievement. Other from birth to age five. These that includes the America COMPETES commenters stated that the flexibilities commenters pointed to research Act elements. Beyond these 12 and autonomies listed in the priority are documenting the importance of high elements, the Department has not essential to school success and that it is quality education in the first three years specified any additional elements that highly unlikely that any State will turn of life. States must include in their statewide around low-performing schools without Discussion: We agree that the Race to longitudinal data systems. these ingredients. Another commenter the Top program should recognize the Changes: None. stated that LEA actions are fundamental importance of early learning programs Comment: One commenter to enabling schools to turn around and in preparing children for success in recommended that States use that if this priority was a competitive school. Therefore, as noted elsewhere, longitudinal data to evaluate and preference priority, it would motivate we are adding priority 3 to focus on improve the effectiveness of programs LEAs to undertake challenging reforms. improving early educational outcomes designed to facilitate vertical alignment Lastly, one commenter recommended for high-need students who are young in the education system. Two that the priority be changed to an children (pre-kindergarten through third commenters recommended that the absolute priority. grade). Because Race to the Top focuses Department include an incentive in this Discussion: States may choose to its efforts primarily on States and LEAs, priority for States and LEAs to learn address priority 6, which examines the
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extent to which a State’s participating describe the ways in which their targets by coordinating, reallocating, or LEAs are broadly creating the participating LEAs provide schools, in repurposing education funds from other conditions for reform and innovation by particular turnaround schools, with Federal, State, and local sources where providing schools with flexibilities and flexibilities and autonomies conducive feasible. We, therefore, believe it is autonomies. All States, however, will be to reform and innovation. unnecessary to add to priority 6 the rewarded for flexibilities and Discussion: Under criterion (E)(2), language regarding coordinated autonomies that are provided to schools States must describe the ways in which planning between categorical programs in the highest need situations—turning they will support their LEAs to and budgets and changing delivery around persistently lowest-achieving implement the flexibilities provided in models suggested by the commenter. schools—as part of criterion (E)(2). In the school intervention models In response to commenters who addition, criterion (F)(2) will assess the (described in Appendix C) for their recommended that the Department extent to which States ensure successful persistently lowest-achieving schools. provide additional regulatory waivers conditions for high-performing charter Therefore, in addressing priority 6, a and flexibilities, we note that such schools and other innovative schools. State should describe other flexibilities waivers and flexibilities are often Therefore, we do not believe it is and autonomies that its LEAs currently limited by statute. However, the necessary to change priority 6 to an provide, or plan to provide, to their Department fully supports efforts to absolute or competitive preference schools in order to create the conditions coordinate the use of funds in order to priority. for reform, innovation, and learning. make the most efficient and effective Changes: None. Changes: None. use of limited resources and will Comment: A few commenters noted Comment: One commenter continue to consider States’ requests for that priority 6 focuses on school-level recommended that priority 6 be changed waivers that are permissible under conditions for reform and innovation to reach beyond LEA-school governance current Federal statutes and regulations. but does not speak to the conditions that to include State-LEA flexibility and Changes: None. are necessary for student learning. The autonomy. The commenter stated that Comment: A few commenters commenters recommended that the title emphasis should be placed on recommended that the list of and content of the priority be changed demonstrating how changes in flexibilities and autonomies conducive to also focus on creating the school-level governance and rules affect school to reform and innovation include conditions for learning. One commenter reform efforts and instructional providing high-quality, engaging stated that school-level conditions for innovations. The commenter further curricula and instruction that focus on reform should be clearly defined in the recommended that we add examples of real-world problem solving. The notice to ensure that all of the flexibilities and autonomies conducive commenters also recommended that comprehensive learning opportunities to reform and innovation such as instruction be consistent with the necessary for school success are in coordinated planning between principles of universal design for place. categorical programs and budgets, learning. Discussion: We agree with the changing education delivery models to Discussion: Several Race to the Top commenters that priority 6 should increase productivity, and more selection criteria established in this emphasize reform and innovation in the efficiently using existing learning time final notice emphasize an approach to service of learning, and thus are adding and resources. curriculum and instruction that is based ‘‘learning’’ to the title of the priority. We A few commenters recommended that on an evidence-driven cycle of also are clarifying, in the text of the the Department provide additional continuous instructional improvement priority, that the Secretary is interested regulatory waivers and flexibilities to (see criteria (B)(3), (C)(3), and (D)(5)). in applications in which the State’s improve the coordination of funds and Because this issue is addressed directly participating LEAs create the conditions create the conditions for systemic in the criteria, we do not believe it is for reform and innovation, as well as the reforms and instructional innovations. necessary to reference specific conditions for learning. We decline to One commenter stated that Federal principles used to design curricula or provide an exhaustive list of school- funding and regulatory flexibility could instruction (i.e., universal design for level conditions for reform as requested have a significant effect on State and learning). by one commenter as such conditions LEA reform efforts and suggested that Changes: None. will vary depending on the unique funds be competitively awarded in Comment: A few commenters needs of schools and communities. return for a State meeting a number of requested that priority 6 clearly state Therefore, priority 6 only includes key requirements. that the flexibilities and autonomies examples of flexibilities and autonomies Discussion: The Department is placing provided to schools must not include that an LEA might provide to its schools particular emphasis on these school- waiving the program requirements in order to help create the conditions for level flexibilities because their under the IDEA. reform, innovation, and learning. We effectiveness has been shown in a Discussion: There is nothing in also are making a few technical edits for number of educational settings and priority 6 to suggest that LEAs would be clarity. because they are related to efforts to permitted to waive program Changes: We have changed the title of turn around struggling schools, which is requirements required under other priority 6 to ‘‘School-Level Conditions a priority of the ARRA. We are, Federal laws and regulations, including for Reform, Innovation, and Learning.’’ however, open to State innovation those required by the IDEA. Therefore, We have added the phrase ‘‘seek to around exploring further flexibilities we believe it is unnecessary to add the create the conditions for reform and with their LEAs and, to the extent that language requested by the commenters. innovation as well as the conditions for such flexibilities are in place, the State Changes: None. learning. * * *’’ following ‘‘The could describe them in response to Comment: One commenter requested Secretary is particularly interested in criterion (F)(3), Demonstrating Other that the final notice provide examples of applications in which the State’s Significant Reform Conditions. We also flexibilities and autonomies that LEAs participating LEAs.’’ note that under criterion (A)(2)(i)(d), a could provide to schools to improve Comment: One commenter stated that State will be evaluated based on its early learning. The commenter provided in order to meet priority 6, States should capacity to accomplish its plan and numerous examples, including
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increasing the use of Title I funds for ‘‘leadership team members.’’ Another increasing learning time. We early learning programs and permitting commenter stated that school principals acknowledge that the term, ‘‘expanded the use of school facilities for early must have the authority to replace learning time’’ is typically used to refer learning programs and family centers. consistently low-performing educators to programs that redesign the school Discussion: Several of the flexibilities and suggested changing paragraph (i) to day, week, and year to provide and autonomies included in priority 6 clarify that principals should be given additional hours of learning time, and are applicable to early learning—for the authority to select and replace staff. that ‘‘extended learning time’’ is example, flexibility in selecting staff Discussion: We decline to add typically used to describe before school, (paragraph (i)) and controlling the ‘‘leadership team members’’ to after school, and summer programs. We, school’s budget (paragraph (iii)). paragraph (i) in priority 6 because we therefore, are defining a new term, Therefore, we do not believe that are unsure to whom the term refers. increased learning time, to indicate the examples specifically applicable to early With regard to the suggestion that we need for schools to provide additional learning are necessary. We note that, as refer specifically to principals selecting time for academic work to improve the discussed elsewhere in this notice, we and replacing staff, we note that there proficiency of students in core academic are adding an invitational priority may be other school leaders or groups subjects, as well as for additional (Priority 3) focused on early learning. of school staff responsible for hiring subjects and enrichment activities that An applicant who chooses to address staff (e.g., department chairs; a panel of can contribute to a well-rounded the early childhood priority could teachers, parents, and the principal; an education. We agree with commenters choose to include flexibilities, such as executive in a private management that teachers could also use the those recommended by the commenter, organization). Therefore, we decline to additional time to collaborate, plan, and in its application. make the change proposed by the engage in professional development. Changes: None. commenters. Comment: Numerous commenters Changes: None. Changes: We have replaced recommended that the list of ‘‘expanded learning time’’ with flexibilities and autonomies conducive Increased Learning Time (Paragraph (ii)) ‘‘increased learning time.’’ We also have to reform and innovation include Comment: Many commenters added a definition of increased learning charter schools and charter school expressed support for reform efforts that time in the definitions section of this autonomies. Several of these put in place new structures and formats notice to read as follows: ‘‘Increased commenters recommended that States for the school day or year in order to learning time means using a longer be rewarded for their past and proposed expand learning time. Commenters school day, week, or year schedule to efforts to support charter school provided many examples of activities significantly increase the total number flexibilities and, conversely, that States that should be conducted during of school hours to include additional should lose points if they do not expanded learning time including extra- time for (a) instruction in core academic provide adequate school-level autonomy curricular pursuits, experiential subjects, including English; reading or or are implementing efforts to restrict learning, enrichment activities, family language arts; mathematics; science; charter school flexibility. One and community engagement, foreign languages; civics and commenter suggested that we clarify recreational activities, and activities that government; economics; arts; history; that flexibilities and autonomies support students’ transition between and geography; (b) instruction in other conducive to reform and innovation do grade levels. Other commenters focused subjects and enrichment activities that not include policies that would exempt on the use of expanded learning time for contribute to a well-rounded education, charter schools or other non-traditional academic supports, and as a strategy to including, for example, physical public schools from open enrollment improve student achievement, close education, service learning, and mandates or from requirements that achievement gaps, and support experiential and work-based learning they be subject to and rated by the same struggling schools. One commenter opportunities that are provided by academic achievement standards as stated that priority 6 should include partnering, as appropriate, with other traditional public schools. other flexibilities such as expanding organizations; and (c) teachers to Discussion: As part of its application, opportunities for youth that include, but collaborate, plan, and engage in a State is already asked to address are not limited to, a longer school day. professional development within and several criteria to ensure that it is Several commenters recommended across grades and subjects.’’ 2 creating the conditions for high-quality clarifying that expanded learning time charter schools. (See criterion (F)(2)). includes after-school and summer 2 Research supports the effectiveness of well- Therefore, we decline to include school programs. Another commenter designed programs that expand learning time by a additional criteria related to charter strongly recommended that the final minimum of 300 hours per school year. (See notice clarify that expanded learning Frazier, Julie A.; Morrison, Frederick J. ‘‘The schools in priority 6. We also decline to Influence of Extended-year Schooling on Growth of add language specifying the flexibilities time includes strategies that go beyond Achievement and Perceived Competence in Early and autonomies that LEAs may provide those that mirror the instruction Elementary School.’’ Child Development. Vol. 69 to charter schools. State and local provided to students during the school (2), April 1998, pp.495–497 and research done by day. Other commenters stated that it is Mass2020.) Extending learning into before- and governments possess the authority to after-school hours can be difficult to implement authorize charter schools and as such, important for the Department to effectively, but is permissible under this definition requirements for charter school acknowledge that expanded learning with encouragement to closely integrate and admissions are primarily State and local time includes increasing educators’ coordinate academic work between in-school and learning time for activities such as out-of school. (See James-Burdumy, Susanne; matters. Dynarski, Mark; Deke, John. ‘‘When Elementary Changes: None. professional development that is Schools Stay Open Late: Results from The National collaborative, on-site, and tailored to the Evaluation of the 21st Century Community Learning Selecting Staff (Paragraph (i)) needs of school staff and leadership, Centers Program.’’ http://www.mathematica- Comment: One commenter and to allow teachers to plan and learn mpr.com/publications/ redirect_PubsDB.asp?strSite=http:// recommended that paragraph (i) of this together. epa.sagepub.com/cgi/content/abstract/29/4/296 priority specifically refer to schools Discussion: We appreciate the Educational Evaluation and Policy Analysis, Vol. 29 having the flexibility to select numerous comments we received on (4), December 2007, Document No. PP07–121.)
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Comment: Many commenters form partnerships with nonprofit Budgets (Paragraph (iii)) recommended that priority 6 focus on organizations or individuals outside of Comment: One commenter removing barriers to innovative the school; such decisions are best left recommended revising paragraph (iii) approaches to serving students in after- to local decision-makers who regarding placing budgets under the school and summer school programs. understand the unique needs of their schools’ control to ensure that teachers The commenters stated that schools schools and the resources available in and parents are involved in making should be encouraged to allow the use their communities. We are changing the budget decisions. of school buildings for summer language in paragraph (v) regarding Discussion: The process that a school programs. Other commenters comprehensive services to high-need or LEA uses to establish its budget is a recommended requiring LEAs to students to include examples of how local matter. Therefore, we decline to coordinate funding streams for after- such services might be provided to high- add the language requested by the school and summer school programs, need students. commenter. such as those tied to Title I, 21st Changes: The parenthetical in Changes: None. Century Community Learning Centers, paragraph (v) now reads, ‘‘(e.g., by and other Federal, State, and local funds mentors and other caring adults; Credit Based on Student Performance in order to maximize impact, improve through local partnerships with (Paragraph (iv)) efficiencies, and provide comprehensive community-based organizations, Comment: Several commenters services. nonprofit organizations, and other expressed support for awarding credit to Discussion: Priority 6 focuses on providers).’’ creating the conditions for reform, students based on student performance innovation, and learning at the school Comment: One commenter supported instead of instructional time and level and includes a list of the types of expanded learning time but stated that providing multiple pathways to a flexibility and autonomy that LEAs may educators should not be forced to work graduation with a regular high school provide to schools; the list provides longer hours for the same compensation diploma. One commenter recommended examples and is not exhaustive. We do and that adjustments to work schedules that funds be used to encourage State not believe it is necessary to include the should be determined locally between policies that allow middle or high very specific flexibility of removing the district and educators and bargained school students to receive high school barriers to using school buildings for where collective bargaining agreements graduation credit or to meet a subject after-school and summer school exist. A few commenters stated that area requirement earlier than typically programs. Likewise, flexibilities that collaboration among labor, management, would be expected. The commenters permit coordinating funding streams for and parents is critical for expanded advocated for options that create after-school and summer school learning time models to succeed. flexibility for students without programs are already covered in Discussion: Decisions about work sacrificing rigorous learning and cited paragraph (iii) of the priority, which hours and compensation are determined school-work partnerships, diploma-plus references placing budgets under the at the local level. As with all programs, and dual enrollment (high school’s control. educational reform efforts, we believe school-community college) programs as Changes: None. that collaboration among stakeholders is examples of innovative approaches to Comment: One commenter critical to success. creating multiple options that help recommended that LEAs be encouraged Changes: None. students graduate from high school and to form partnerships with providers of pursue additional educational goals. Comment: One commenter out-of-school-time programming that Discussion: We believe that the recommended that the final notice have proven outcomes and that can commenters’ recommendations are all provide a clear picture of how strategies bring innovative approaches to support addressed in paragraph (iv), which for expanded learning time and true reform. Another commenter provides for ‘‘awarding credit to comprehensive services for high-need recommended that States ensure that students based on student performance students fit together as part of a broader nonprofit partners have the opportunity instead of instructional time.’’ We, approach to reform and recommended to apply for extended learning funds in therefore, do not see a need to add the that language be added to encourage partnership with one or more struggling commenter’s recommended language in applications that demonstrate how schools in order to maximize priority 6. competition and increase the quality of States and LEAs will align their Changes: None. programs provided. One commenter strategies to produce results. Comprehensive Services (Paragraph (v)) recommended requiring States to ensure Discussion: It will be up to each that expanded learning time models do applicant to describe how its plan for Comment: A few commenters noted not limit staffing to existing teachers. reform is comprehensive and coherent that instruction and services for high- The commenter stated that flexibility and will increase student achievement, need students cannot be provided by should be provided to engage educators reduce achievement gaps, and increase traditional education systems alone and outside of the school such as tutors, graduation rates. Absolute priority 1 recommended adding language to the mentors, individuals in teaching specifically requires that States priority to emphasize the importance of fellowship programs and alternative comprehensively address each of the community-based organizations and certification programs, and volunteers four education reform areas specified in nonprofit organizations in providing from the community, business, and the ARRA and demonstrate that the comprehensive services to high-need industry. State and its participating LEAs are students. One commenter stated that the Discussion: Developing local taking a systemic approach to education final notice should clarify that the goal partnerships can be an effective strategy reform. Applicants who choose to of State and local educational agencies to move local school reform agendas address priority 6 should address how should be to build a comprehensive forward, particularly in providing their approach to meeting this priority picture of children’s progress— comprehensive services to high-need fits into the State’s overall reform academically, socially, and in terms of students. However, we believe it would efforts. health and well-being. One commenter be inappropriate to require States to Changes: None. stated that in order to provide
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comprehensive services to high-need Fiscal Stabilization Fund program Phase teacher, principal, or student students, States must create a safety net 1 and Phase 2 applications approved in performance. A few commenters of wrap-around services designed to order to be eligible for a Race to the Top disagreed with the Department’s increase student success and focus on award. Other commenters expressed reference to research indicating that both community- and district-level concern that States may have difficulty teacher qualifications, including conditions. obtaining approval of their Stabilization certification status and years of Another commenter suggested using Phase 2 applications in time to submit experience, are not accurately predictive the term ‘‘comprehensive supports’’ a Race to the Top application. One of teacher quality. Other commenters rather than ‘‘comprehensive services,’’ commenter expressed concern that the identified research explaining the stating that ‘‘comprehensive supports’’ Department’s approval of Stabilization difficulty in disaggregating student includes services and has more salience Phase 2 applications may occur too late achievement data to determine a with educators. Another commenter for a State to apply during Phase 1 of the teacher’s effect from other variables. recommended clarifying that Race to the Top competition. One One commenter suggested that States comprehensive services for high-need commenter specifically noted the should pass laws requiring a peer students address the health, safety, difficulty in satisfying the data reviewed validation of any value-added social, emotional, behavioral, physical, requirements for Stabilization Phase 2 methodology before including student and educational needs of a child. in time to apply for the Race to the Top achievement data as part of any Discussion: We agree with the competition. Some commenters evaluation or compensation mechanism commenters that high-need students requested information pertaining to the and further argued that such laws often require a broad array of services timing of Stabilization Phase 2 should not constitute a State barrier that are beyond the capacity of the applications and the Race to the Top under the eligibility requirements. school itself to provide, and that competition. Discussion: As indicated in the NPP, community-based organizations and Discussion: The eligibility we believe that research clearly shows nonprofit organizations play an requirement pertaining to the approval that teacher and principal quality are important role in meeting these needs. of Stabilization applications is being critical contributors to student learning. As noted in an earlier comment changed to require only that the State The Department believes that student regarding the role of community-based have approved Stabilization Phase 1 and achievement and student growth data organizations and nonprofit Phase 2 applications by the time the are meaningful measures of teacher and organizations in schools that provide State is awarded a Race to the Top grant. principal effectiveness, and therefore, increased learning time, we are Thus, a State’s Stabilization Phase 2 should be considered as a part of a changing paragraph (v) to reference application will not need to be rigorous, transparent and fair evaluation community-based organizations and approved at the time it prepares or system. Consequently, legal barriers to nonprofit organizations. submits its Race to the Top application. linking data about student achievement Changes: Eligibility requirement (a) With regard to comments concerning or student growth to teachers and has been changed to read: ‘‘A State must the need for comprehensive services principals for evaluation purposes meet the following requirements in and creating a safety net of wrap-around effectively prevents schools from having order to be eligible to receive funds services with involvement of both the core information systems they need communities and districts, we note that under this program. (a) The State’s applications for funding under Phase 1 to serve students well. For these priority 5 focuses on the need to reasons, we decline to make substantive coordinate services across schools, State and Phase 2 of the State Fiscal Stabilization Fund program must be changes to eligibility requirement (b). agencies, and community partners in approved by the Department prior to the Changes: None. order to ensure that high-need students State being awarded a Race to the Top Comment: Several commenters asked have access to the broad array of grant.’’ whether teacher or principal contracts opportunities and services they need Eligibility Requirement (b): Linking or local collective bargaining (see the discussion on priority 5). Student Data to Teachers and agreements that prohibit the use of We decline to change the term Principals: student achievement data for teacher ‘‘comprehensive services’’ to Comment: Numerous commenters and principal evaluations would ‘‘comprehensive supports,’’ as requested expressed their support for evaluating constitute a State barrier, thus making a by one commenter; we do not agree that teachers and principals based on State ineligible for the Race to the Top the two terms are substantively different student achievement or growth. These competition. One commenter noted that or that one term has more salience for commenters suggested that the final one specific State lacks control over educators than the other. We also notice should require States to use teacher and principal evaluation decline to specify the array of services student growth data in teacher and systems. included in ‘‘comprehensive services’’ principal evaluations. Several Discussion: The Department has because, by doing so, we could commenters offered their support for the revised eligibility requirement (b) to inadvertently restrict the range of requirement that a State not have any clarify that the State must not have any services that a State may determine are barriers to linking student achievement legal, statutory, or regulatory barriers at necessary to serve high-need students. or student growth data to teacher and the State level to linking student Changes: None. principal evaluations. These achievement or student growth data to II. Requirements commenters specifically noted that teachers and principals for purposes of teachers should be judged by their evaluation. Therefore, a State would be Eligibility Requirements effectiveness, not by their credentials or eligible to apply for a Race to the Top Eligibility Requirement (a): State years of service. grant even if a teacher or principal Fiscal Stabilization Fund (Stabilization) Several commenters, however, contract or collective bargaining Phase 1 and 2: claimed that there is a lack of research agreement at the local level prohibited Comment: Many commenters or evidence demonstrating that the use the use of student achievement or expressed support for the eligibility of such data for teacher and principal student growth data for evaluation requirement that States have their State evaluations has any positive impact on purposes.
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Changes: Eligibility requirement (b) Changes: None. principal effectiveness. State level data has been changed to read: ‘‘At the time Comment: Some commenters linkage barriers unduly restrict schools the State submits its application, there suggested that States should be eligible and LEAs from using student must not be any legal, statutory, or for the Race to the Top competition achievement or student growth data to regulatory barriers at the State level to even if barriers exist to linking student identify and improve teacher and linking data on student achievement (as achievement or student growth data to principal effectiveness. The Department defined in this notice) or student growth teachers and principals for evaluation also believes that schools and LEAs (as defined in this notice) to teachers purposes, so long as the State’s reform should have the ability to choose to use and principals for the purpose of plan only includes LEAs and charter student achievement and student teacher and principal evaluation.’’ schools that allow such linkages. One growth data in this manner. For this Comment: One commenter suggested commenter argued that the eligibility reason, the Department declines to limiting the eligibility requirements requirement is unfair because LEAs exempt any one State from this pertaining to linking student without such prohibitions would not requirement and encourages States to achievement data to teacher and receive Race to the Top funds if they lift legal, statutory, and regulatory principal evaluations to exclude were situated in a State with such barriers that prohibit these linkages. educators working in early learning or barriers. The Department notes that this notice child care programs. This commenter Discussion: Under eligibility requires the State’s Attorney General to claimed that teacher and principal requirement (b), States are required to certify that the State has no legal, evaluation systems would not be demonstrate that they do not have any statutory, or regulatory barriers at the applicable to a State’s proposal legal, statutory, or regulatory barriers at State level to linking student emphasizing early learning initiatives. the State level to linking student achievement or student growth data to Discussion: The Department believes achievement or student growth data to teachers and principals for the purpose that student growth data are strong teachers and principals for the purpose of evaluations. measures of teacher effectiveness across of evaluations. States that have such Changes: None. the spectrum from preschool to grade barriers are not eligible for Race to the 12. While traditional student Top awards. Race to the Top is meant Eligibility Overall achievement and student growth data to provide an incentive for statewide Comment: Multiple commenters may not be routinely collected in early reform and improvements, and is a suggested adding an eligibility learning settings, relevant student competitive grant program encouraging requirement to limit eligibility for Race achievement and student growth data States to be bold and innovative. While to the Top funds to States that meet the are available in other forms. Child individual LEAs and charter schools in requirements in their FY 2007 Annual outcome data should not be the only States with barriers may be ready and Performance Report under the IDEA. measures of teacher effectiveness in eager to use student growth data to Those commenters noted that States early learning settings, but can provide identify and improve teacher and unable to meet basic IDEA requirements useful information to improve the principal effectiveness, Race to the Top should not be eligible to apply for Race effectiveness of early childhood focuses on the extent to which the to the Top funds. educators and administrators when State’s conditions and plans lead to Discussion: Race to the Top is a coupled with other quantitative and statewide impact. competitive grant program intended to qualitative indicators. Changes: None. improve educational outcomes for all Changes: None. Comment: Numerous commenters students. The Department already has a Comment: One commenter argued that one specific State’s law, mechanism to monitor States’ progress, recommended that the notice clarify which prohibits linking teacher and as reported in their Annual Performance what level of change to a State law student achievement data, should not Reports, in meeting the targets in their regarding linking data on student disqualify it from applying for the Race State Performance Plan under the IDEA. achievement or student growth to to the Top competition. Some of these Therefore, we decline to include the teachers and principals would be commenters argued that the State’s law requirement suggested by the necessary in order to be eligible for Race does not prohibit data linking between commenter as an eligibility requirement to the Top funds. For example, one students and teachers at the district in the Race to the Top competition. commenter asked if legislation to level where personnel decisions are Changes: None. remove a barrier to linking student made, and therefore should not make Comment: One commenter suggested achievement data to teachers and the State ineligible for Race to the Top the Department consider the number of principals would need to be enacted funds. One commenter, however, outstanding audits and audit exceptions prior to applying for Race to the Top specifically stated their support for the against a State for any Federal education funds or whether the introduction of data linkage eligibility requirement with program as part of the Race to the Top such legislation would be adequate to respect to the State. program eligibility determination. One the meet eligibility requirements. Another commenter argued that an commenter suggested that if awards Another commenter asked whether a existing statute regulating the use of were given to States with audit State would need to enact legislation student achievement data in tenure exceptions, conditions should be adopting its plan in its State education determinations in another State should imposed on the award of funds, code to be eligible to apply for Race to not make the State ineligible to apply including onsite monitoring. the Top funds. for the Race to the Top competition. The Discussion: The Department has taken Discussion: Eligibility requirement (b) commenter argued that the statute does extraordinary measures to ensure contemplates only existing laws; a State not prohibit use of student test data in accountability in the use of all ARRA will not be able to establish its annual teacher performance reviews or funds, including the Race to the Top eligibility based on intent to change for tenure consideration. program, so that all dollars are used those laws. There is no requirement in Discussion: As stated earlier, the wisely and accounted for in a the ARRA or in this notice requiring Department believes that student growth transparent manner. Indeed, as States to enact legislation adopting their should be one significant measure of explained in the Reporting section of Race to the Top plans. several when evaluating teacher and this final notice and the notice inviting
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applications, successful applicants must Department provide a ‘‘test’’ for incomes below the poverty line; or for comply with the ARRA annual reporting Attorneys General to apply to their State which not less than 20 percent of the requirements in section 14008 of the law to determine eligibility. children served by the LEA are from ARRA and quarterly reporting Discussion: Under application families with incomes below the requirements in section 1512(c) of the requirement (f) (proposed application poverty line.’’ ARRA, which are designed to ensure requirement (h)), the State’s Attorney Consistent with section 14006(c) of thorough and public oversight of the General is asked to certify that the State the ARRA, States must subgrant 50 expenditure of ARRA funds. The has no legal, statutory or regulatory percent of their grant awards to Department has established a Recovery barriers at the State level with respect to participating LEAs, based on the LEAs’ Act Web site and hotline for members eligibility requirement (b). We interpret relative share of Title I, Part A of the public to report suspected misuse this to mean State constitutions, case allocations in the most recent year. We of funds. Additionally, the Department law, statutes, or regulations. have clarified in application has other mechanisms and protections Interpretation of a State’s laws falls requirement (c)(2) that, because all Race in place to enforce and monitor progress uniquely within the expertise of the to the Top grants will be made in 2010, and resolution of any prior audit State Attorney General and therefore, relative shares will be based on total findings from other programs. we leave this task to the Attorney funding received in FY 2009, including Accordingly, we do not believe it is General. The Department notes that the both the regular Title I, Part A necessary to add requirements certification requirement does not seek appropriation and the amount made pertaining to States that have audit a formal legal opinion. Instead, the available by the ARRA. exceptions. Department provides forms in the Consistent with section 14005(c)(4) of Changes: None. application for Attorneys General to the ARRA, application requirement sign certifying that (a) the description (c)(2) requires a State to include in its Application Requirements of, and statements and conclusions in application a budget detailing how the Reorganization of the Application the application concerning State law, State will use Race to the Top funds to Requirements statute, and regulation in its application ‘‘give priority to high-need LEAs’’ are complete, accurate, and constitute a beyond the base amount provided to all Comment: None. reasonable interpretation of State law, participating LEAs. States have Discussion: In order to streamline the statute and regulation; and (b) that the flexibility to determine the meaning of application requirements and the State does not have any legal, statutory, ‘‘give priority to,’’ which could include, criteria and reduce burden for or regulatory barriers at the State level for example, additional funding, more applicants, we are removing from this to linking data on student achievement comprehensive technical assistance, final notice proposed application or student growth to teachers and coordination of State or local social requirements that were duplicative of principals for the purpose of teacher services for students in such LEAs, the criteria. The remaining application and principal evaluations. The expanded professional development, requirements are being renumbered, certification of the Attorney General and larger incentives for teachers and accordingly. For instance, proposed addresses this requirement. The principals who agree to work in these application requirement (c) concerning applicant may provide explanatory LEAs. the level of State funding for education information, if necessary. Changes: Application requirement is being removed from the final In addition, we note that we are (c)(2) has been revised to include: application requirements but is still changing application requirement (f) to ‘‘(Note: Because all Race to the Top being retained in criterion (F)(1)(i); and be consistent with the changes to grants will be made in 2010, relative proposed application requirement (d) eligibility requirement (b), as discussed shares will be based on total funding concerning support from stakeholders is earlier, and separating application received in FY 2009, including both the being removed but is still being retained requirement (f) into two subparagraphs. regular Title I, Part A appropriation and in criterion (A)(2)(ii). In addition, we are Changes: Application requirement (f) the amount made available by the revising the application requirements to has been made consistent with ARRA).’’ make minor editorial changes, providing eligibility requirement (b), as discussed Reporting Requirements internal cross references to relevant earlier, and separated into two portions of the notice, and reorganizing subparagraphs. Comment: Several commenters raised application requirement (e) to better questions concerning accountability for clarify the components of this High-Need LEAs Race to the Top funds. One commenter requirement. Comment: Many commenters had praised the proposed requirements but Changes: We have removed proposed difficulty interpreting proposed wanted greater detail on how we would application requirements (c) and (d). We application requirement (e)(2) that ensure ‘‘successful on-the-ground have reordered the application would have required States to explain in implementation’’ of the Race to the Top requirements accordingly. We have their budget plans how it will use Race program. One strategy suggested by the made minor editorial changes to provide to the Top funds to give priority to high- commenter was to withhold funds from better clarification to this section, have need LEAs over and above the States that do not meet the clarified that the Governor must sign the participating LEA share. commitments they make in their Race to assurances in Section IV of the Discussion: First, the Department the Top applications. Other commenters application, and have reorganized notes that it inadvertently neglected to recommended that Race to the Top application requirement (e). use the statutory definition of high-need funds be conditioned on meeting Comment: Some commenters LEA in the NPP, as found in section performance goals as reflected in the recommended providing benchmarks or 14013(2) of the ARRA. Accordingly, and annual reports, or that the Department statutory tests to help provide as discussed in this notice, we are withhold funds from those States not consistency in how State Attorneys changing the definition of high-need meeting their commitments. Two General determine and certify their LEA to reflect the statutory definition: commenters requested flexibility for State’s eligibility for Race to the Top. ‘‘[an LEA] that serves not fewer than States to revise their State plans to Some commenters suggested that the 10,000 children from families with encourage continuous improvement.
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Discussion: The Reporting the grant; a final determination will be State grantees. The Department’s goal Requirements section in this final notice made at the time of grant awards. We do for these evaluations is to ensure that its explains that the Department plans to not believe it is necessary to arbitrarily studies not only assess program impacts both support and carefully monitor require these agreements for all grantees but also provide valuable information to State and LEA progress in meeting their because the determination whether to State and local educators to help inform goals, timelines, budgets, and annual use a cooperative agreement as the and improve their practices. We are not performance targets. If we determine award instrument is based on the nature requiring through this notice that Race that a State is not meeting one or more of the relationship and the activities to to the Top grantee States conduct of the requirements for this program, the be performed by the grantee, and is independent evaluations. However, they Department may take a range of actions therefore highly case specific. are free to propose, within their to remedy the situation, including Changes: None. applications, to use funds from Race to placing the State in high-risk status, the Top to support independent putting the State on reimbursement Program Requirements evaluations. A full explanation of the payment status, or delaying or Evaluation Race to the Top evaluation plan is withholding funds. The Department also Comment: In response to the NPP’s included in the Program Requirements section of this notice and the notice recognizes that States may wish to, or request for advice on the best way to need to, revise their Race to the Top inviting applications. conduct an evaluation of the Race to the plans occasionally to take into account Changes: We have revised the Top program, many commenters changing circumstances; such revisions Program Requirements section to reflect recommended that States conduct their will be subject to approval by the the evaluation requirements for all own Race to the Top evaluations. These Secretary. The Department recognizes States that win a Race to the Top grant. commenters believed that the likely that many of the accountability Specifically, this notice has been breadth of variation in Race to the Top requirements of the Race to the Top revised to require State grantees to plans would make it difficult to conduct program differ from those of the ESEA, participate in a series of national a national evaluation, and that State- and that winning States will be adding evaluations that will be conducted by level evaluations would provide the a new layer of goal-setting, performance IES. This notice has been revised to kind of detailed feedback needed to measurement, and data collection to reflect that these evaluations will support continuous improvement. their existing accountability systems. involve components described further However, another commenter asserted Finally, to provide greater clarity and in this notice, including surveys, case that a relatively small number of States completeness to the Reporting studies, and evaluation of outcomes. We were expected to receive a Race to the Requirements section, we are including have further clarified that States have Top award and, according to the the reporting requirements contained in the option of conducting additional commenter, that a national evaluation is sections 1512(c) and 14008 of the evaluations using Race to the Top funds a far more efficient method than using ARRA. or other funds. We have also revised Race to the Top funds to pay for Changes: We have added the this notice to reflect that State grantees, individual State-led evaluations. reporting requirements contained in LEAs, and schools are expected to Another commenter emphasized the sections 1512(c) and 14008 of the identify and share promising practices importance of a national evaluation of ARRA. and make data available to help all the Race to the Top program using State Comment: One commenter argued States focus on continuous data. A few commenters recommended that the Department may not use written improvement. performance agreements or cooperative that we carry out both national and agreements to monitor a State’s progress State-level evaluations of the Race to the Participating LEA Scope of Work because, they claimed, ARRA only Top program. Comment: None. allows grants monitoring. Another Other commenters requested Discussion: The Program Requirement commenter stated that the Department information on funding for Race to the concerning Participating LEA Scope of should be a full participant in the Race Top evaluations, and two commenters Work is addressed in the discussion for to the Top program and, therefore, that recommended that up to 10 percent of Section A, State Success Factors. Race to the Top awards should be Race to the Top awards be available to Change: The Program Requirement cooperative agreements, rather than support those evaluations. One section is revised to include a grants. commenter expressed concern that the requirement on Participating LEA Scope Discussion: The Department intends reporting requirements were focused on of Work. to support States and LEAs through outcomes only, and did not include a technical assistance, evaluations, and description of the processes used to Making Work Available other mechanisms to facilitate them in achieve those outcomes. Finally, four Comment: Two commenters suggested meeting their goals, timelines, budgets, commenters suggested that a national that the Department require that any and annual performance targets. evaluation should focus on identifying new educational materials developed by Contrary to the assertion by one promising or best practices, while two Race to the Top State grantees be made commenter, the Department has the commenters recommended the available as open educational resources. authority under the Federal Grant and inclusion of ‘‘process metrics’’ to ensure One of these recommended that all Cooperative Agreement Act of 1977 (31 that best practices can be fully outputs be open source and royalty-free. U.S.C. Chapter 63) to use written documented to facilitate dissemination Several other commenters expressed performance agreements or cooperative and adoption by others. concern about copyrighted intellectual agreements to monitor Race to the Top Discussion: The Department property, proprietary systems, and the grantee performance. As stated in the appreciates this advice on how to rights of contractors or partners, and NPP and reiterated in this notice, the structure an evaluation plan for the Race that a requirement to share all outputs Department may require grantees to to the Top program. As described later would preclude States from entering enter into a written performance or in this notice, the Institute of Education into contracts or licensing agreements or cooperative agreement with the Sciences (IES) will conduct a series of would conflict with agreements already Department as a condition of receiving national evaluations of Race to the Top in place. A commenter noted that one
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specific State relies on subscriptions to Discussion: The Department intends in the discussion of (A)(3)(ii) later in this copyrighted services for data to conduct extensive technical notice. warehousing and would have to build assistance activities related to Race to Comment: Many commenters new systems to share data tools freely the Top grants and will utilize to the requested clarification regarding with the public. Two commenters extent feasible all available resources, funding for LEAs under the Race to the suggested using the exclusion in the including federally supported research Top program, State discretion to select Statewide Longitudinal Data Systems centers and regional laboratories, to participating LEAs, and whether LEAs grant program to protect intellectual support those activities. In addition, we may decline Race to the Top funding. property and proprietary products in will work to minimize the cost of this Many commenters questioned whether Race to the Top. technical assistance to participants. State applications may exclude LEAs Discussion: We understand and agree Changes: None. that are not committed to part or all of with the concerns about proprietary a State’s Race to the Top plan. One information in the context of the Using Subgroups Under NAEP and the ESEA commenter recommended giving States proposed requirement that States and complete control over how Race to the LEAs make available materials Comment: None. Top funds are spent by participating developed with Race to the Top funds. Discussion: The application LEAs, claiming that the State, not the We are revising the Program requirement concerning use of LEA, will be held accountable for Requirements section entitled Making subgroups under NAEP and the ESEA meeting Race to the Top goals and Work Available to provide that such for reporting achievement gains and for targets. Other commenters suggested materials must be available ‘‘unless setting future targets is addressed in the that Race to the Top funds should be otherwise protected by law or agreement discussion for Section A, State Success awarded only to LEAs that sign an as proprietary information.’’ We also Factors. agreement or otherwise fully agree to have clarified that this agreement Changes: We have added new implement its State’s Race to the Top applies to work developed under this paragraph (g) in the application plans. One commenter asked whether grant. requirements that explains the subgroup LEAs receiving a share of the 50 percent Changes: The Making Work Available data that a State must provide in various of Race to the Top funds distributed on requirement has been revised to read as parts of the application. the basis of the Title I, Part A formula follows: ‘‘Unless otherwise protected by A. State Success Factors under the ESEA are required to law or agreement as proprietary participate in the Race to the Top information, the State and its Definitions: college enrollment, program. Several commenters asked if subgrantees must make any work (e.g., involved LEAs, participating LEAs. LEAs would be subject to Race to the materials, tools, processes, systems) Comments regarding the preceding Top requirements even if they declined developed under its grant freely definitions are addressed, as to participate. available to others, including but not appropriate, below. Discussion: In response to these limited to by posting the work on a Web New Selection Criterion (A)(1)(i) comments, and because LEAs are site identified or sponsored by the ultimately responsible for implementing Department.’’ Comment: None. many of the items in a State’s Race to State Summative Assessments Discussion: As noted elsewhere, we the Top plan, we have made a number are adding a new section, ‘‘State Success of changes to provide great clarity on Comment: None. Factors,’’ to the beginning of the Discussion: The Program Requirement how LEAs can be involved in a State’s Selection Criteria section in order to concerning State summative plan. First, we are providing that LEAs provide an opportunity for States to assessments is addressed in the can be included in States’ Race to the begin their Race to the Top proposals discussion for Section B, Standards and Top projects at one of two levels: as with a clear statement of their Assessments. ‘‘participating LEAs’’ or as ‘‘involved comprehensive and coherent statewide Changes: The Program Requirement LEAs.’’ reform agendas. We are adding criterion Section is revised to include a program Participating LEAs, as defined in this (A)(1)(i) which will be used to assess the requirement on State summative notice, means LEAs that choose to work extent to which a State is successful in assessments. with the State to implement all or articulating the State’s reform agenda. significant portions of the State’s Race Technical Assistance Changes: Criterion (A)(1) begins: to the Top plan, as specified in each Comment: One commenter expressed ‘‘Articulating the State’s education LEA’s agreement with the State. Each support for the requirement that States reform agenda and LEAs’ participation participating LEA that receives funding participate in the Department’s in it: The extent to which—(i) The State under Title I, Part A will receive a share technical assistance activities. This has set forth a comprehensive and of the 50 percent of a State’s grant award commenter also suggested that technical coherent reform agenda that clearly that the State must subgrant to LEAs, assistance be provided by the federally articulates its goals for implementing based on the LEA’s relative share of supported research and development reforms in the four education areas Title I, Part A allocations in the most infrastructure, such as the regional labs. described in the ARRA and improving recent year, in accordance with section Another commenter argued that because student outcomes statewide, establishes 14006(c) of the ARRA. Any participating successful implementation may be a clear and credible path to achieving LEA that does not receive funding under difficult, the Department should devote these goals, and is consistent with the Title I, Part A (as well as one that does) more resources and personnel to specific reform plans that the State has may receive funding from the State’s providing clear and fair technical proposed throughout its application.’’ other 50 percent of the grant award, in assistance. One commenter Selection Criteria (A)(1)(ii) and (iii): accordance with the State’s plan. recommended that the Department Participating LEAs (proposed criteria States do not have the discretion to provide States with funds to cover the (E)(3)(iv) and (E)(4)): select participating LEAs; instead, each estimated costs of participating in Note: A number of comments common to LEA will make the decision to sign on technical assistance. criteria (A)(1)(iii) and (A)(3)(ii) are addressed to the State’s plan as a participating
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LEA. All LEAs that agree to work with In general, involved LEAs are not Race to the Top activities; these should the State, and that sign valid agreements included in, and are not subject to, the be consistent with the LEA’s agreement stating their commitment to implement requirements of a State’s Race to the with the State. Consequently, we do not all or significant portions of the State’s Top plan. believe that there is a need for a plan (as defined by the State) must be It is important to note that this notice definition of participating school in this included in the State’s plan. States do does not require LEAs to participate in notice. have the flexibility to develop detailed a State’s plan (whether as participating Changes: None. reform plans in which LEAs must or as involved LEAs) or give States the Comment: Commenters requested choose whether to participate. States authority to impose such a requirement. additional clarification pertaining to also have the authority to define the Rather, through the definitions of how States would identify and account ‘‘significant portions’’ of their Race to participating LEA and involved LEA, we for LEA participation and support in the Top plans that LEAs must agree to are setting the parameters for what LEAs State reform plans. Multiple implement in order to qualify as must do to be eligible for certain commenters recommended that participating LEAs. As described earlier, funding streams. In addition, through participating LEAs and charter schools States that receive a Race to the Top absolute priority 1, the Department is formally declare their support in writing grant must use at least 50 percent of the specifying that States will only be as part of the Race to the Top award to provide subgrants to their awarded grants if they demonstrate application. One commenter participating LEAs based on their sufficient LEA participation and recommended requiring States to list all relative shares of funding under Part A commitment to successfully implement the LEAs that requested to be included of Title I of the ESEA for the most recent and achieve the goals of their plans; and in designing and developing the State year. Because all Race to the Top grants through criteria (A)(1)(ii) and (A)(1)(iii), plan. will be made in 2010, relative shares this notice sets forth the terms by which Discussion: Proposed criterion will be based on total funding received reviewers will award points to each (E)(3)(iv) was included to elicit in FY 2009, including both the regular State based on the participation and information about the extent of the Title I, Part A appropriation and the commitment of their LEAs. commitment to and participation of amount made available by ARRA. The Changes: We have added two new LEAs in a State’s Race to the Top plan. remaining funds will be available to the definitions to this notice. The definition Because we believe that States should State for State-level activities and for of participating LEAs clarifies that begin their Race to the Top proposals disbursement to participating LEAs participating LEAs choose to work with with clear statements of their entire (regardless of their Title I eligibility), the State to implement all or significant reform agendas, and because LEA involved LEAs, or other entities, portions of the State’s Race to the Top implementation is a central component consistent with the State’s plan. A State plan, as specified in each LEA’s of that agenda, we are moving this has no obligation to provide Race to the agreement with the State. Each criterion into the new ‘‘State Success Top funds, benefits, or supports to non- participating LEA that receives funding Factors’’ section. Furthermore, to add participating LEAs. under Title I, Part A will receive a share clarity, we are dividing the proposed Participating LEAs must in turn use of the 50 percent of a State’s grant award criterion into two revised criteria. In their funding in a manner that is that the State must subgrant to LEAs, this final notice, criterion (A)(1)(ii) consistent with the State’s plan and its based on the LEA’s relative share of addresses the level of commitment MOU or other binding agreement with Title I, Part A allocations in the most among participating LEAs, while the State. States may establish more recent year, in accordance with section criterion (A)(1)(iii) addresses the extent detailed rules on uses of funds provided 14006(c) of the ARRA. Any participating of LEA participation. they are consistent with the ARRA, the LEA that does not receive funding under Because the extent of LEA terms of the grant award, and the Title I, Part A (as well as one that does) participation should be measured partly Department’s applicable administrative may receive funding from the State’s by the expected effects on student regulations. Although participating other 50 percent of the grant award, in outcomes statewide, we have LEAs will receive subgrants from the accordance with the State’s plan. incorporated into criterion (A)(1)(iii) the State as described earlier, Race to the The definition of involved LEAs language from proposed criterion (E)(4) Top funds are not governed by the Title clarifies that such LEAs choose to work regarding a State’s goals for increasing I restrictions on the uses of funds. with the State to implement those student achievement, decreasing As described earlier, participating specific portions of the State’s plan that achievement gaps, and increasing LEAs agree to implement all or a necessitate full or nearly-full statewide graduation rates. As discussed later, we significant portion of State’s Race to the implementation, such as transitioning to also include new criterion (A)(1)(iii)(d) Top plans. However, other LEAs may a common set of K–12 standards (as regarding increasing college enrollment choose to work with the State to defined in this notice). Involved LEAs and credit accumulation. implement those specific portions of the do not receive a share of the 50 percent In addition, as evidence to support State’s plan that require statewide or of a State’s grant award that it must the State’s response to criteria (A)(1)(ii) nearly statewide implementation, such subgrant to LEAs in accordance with and (A)(1)(iii), Appendix A to this as transitioning to a common set of section 14006(c) of the ARRA, but States notice asks States for the following K–12 standards. We have defined these may provide other funding to involved information: (1) An example of the LEAs in this notice as involved LEAs. As LEAs under the State’s Race to the Top State’s standard participating LEA MOU defined, involved LEAs do not receive grant in a manner that is consistent with and description of variations used, if a share of the 50 percent of a State’s the State’s application. any; (2) the completed summary table grant award that it must subgrant to Comment: Many commenters indicating which specific portions of the LEAs in accordance with section recommended that the Department State’s plan each LEA is committed to 14006(c) of the ARRA, but States may define ‘‘participating school’’ in the implementing and relevant summary provide other funding to involved LEAs final notice. statistics; (3) the completed summary under the State’s Race to the Top grant Discussion: Participating LEAs are table, indicating which LEA leadership in a manner that is consistent with the responsible for determining the roles signatures have been obtained; (4) the State’s application. and responsibilities of their schools in completed summary table, indicating
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the numbers and percentages of NAEP and the assessments required Comment: One commenter suggested participating LEAs, schools, K–12 under the ESEA; that final agreements with participating students, and students in poverty; (5) (c) Increasing high school graduation LEAs should be based on the actual tables and graphs that show the State’s rates (as defined in this notice); and amount of funding a State receives and, goals, overall and by subgroup, (d) Increasing college enrollment (as therefore, that States should not be requested in criterion (A)(1)(iii), defined in this notice) and increasing required to provide detailed MOUs with together with the supporting narrative; the number of students who complete at their applications. and (6) the completed detailed table, by least a year’s worth of college credit that Discussion: The Department agrees LEA, that includes the information is applicable to a degree within two that LEAs should not have to provide requested in criteria (A)(1)(ii) and years of enrollment in an institution of final agreements detailing their precise (A)(1)(iii). higher education. activities at the time that States apply, As discussed in greater detail Finally, Appendix A, Evidence and and as discussed earlier, we are elsewhere in this notice, the Department Performance Measures, has been revised clarifying in the new Participating LEA is providing a sample MOU (see to specify the evidence that States must Scope of Work requirement that States Appendix D) to assist States and LEAs submit when responding to criteria will have 90 days after the receipt of a during this process. (A)(1)(ii) and (A)(1)(iii). grant to negotiate the final scope of Changes: Criterion (A)(1)(ii) specifies Memoranda of Understanding (MOUs) work agreements with their participating LEAs. However, we that reviewers will evaluate the extent Comment: Many commenters to which the participating LEAs are believe that it is critical that LEAs requested clarification regarding the indicate, at the time they sign their strongly committed to the State’s plans MOUs between States and participating and to effective implementation of the MOU in connection with the State’s LEAs, including the purpose, application, which parts of the State’s four education reform areas, as requirements, and expected contents of evidenced by Memoranda of plan they will participate in the MOUs. implementing. Peer reviewers must Understanding (MOUs) (as set forth in Discussion: We agree with the Appendix D) or other binding have this information in order to commenters that additional clarification determine, under criterion (A)(1)(ii), agreements between the State and its is needed on the purpose and content of participating LEAs (as defined in this whether the State’s participating LEAs the MOUs. As discussed earlier, we are are indeed strongly committed to the notice) that include— clarifying in criterion (A)(1)(ii) the (a) Terms and conditions that reflect State’s plan. We also note that, because elements of the MOU or other binding we are providing nonbinding budget strong commitment by the participating agreements that reviewers will consider ranges in the notice inviting LEAs (as defined in this notice) to the in evaluating LEA commitment. We also applications and encouraging States to State’s plans; are adding a new requirement that propose budgets that match the plans (b) Scope-of-work descriptions that clarifies the expectations for the they propose, States should have some require participating LEAs (as defined Participating LEA scope of work. sense of the expected funding available in this notice) to implement all or Finally, we are including in Appendix for LEAs before they apply for their significant portions of the State’s Race D to this final notice a model MOU to grants. to the Top plans; and provide further guidance to States in Changes: None. (c) Signatures from as many as preparing these agreements with their Comment: One commenter possible of the LEA superintendent (or LEAs. recommended that the Department equivalent), the president of the local Changes: We have added to the accept a signed ‘‘certification of school board (or equivalent, if program requirements a new consultation,’’ rather than an MOU. The applicable), and the local teachers’ Participating LEA Scope of Work commenter stated that such a union leader (if applicable) (one requirement, which clarifies that the certification would be the more signature of which must be from an agreements signed by participating appropriate method for demonstrating authorized LEA representative) LEAs (as defined in this notice) must agreement in the commenter’s State. demonstrating the extent of leadership include a scope-of-work section. The Discussion: We understand that States support within participating LEAs (as scope of work submitted by LEAs and may have processes and procedures defined in this notice). States as part of their Race to the Top other than an MOU that they use to In addition, criterion (A)(1)(iii) applications will be preliminary. establish agreements with their LEAs. specifies that LEA participation will be Preliminary scopes of work should As long as such certifications or evaluated based on the extent to which include the portions of the State’s agreements are binding, they may be the LEAs that are participating in the proposed reform plans that the LEA is included in a State’s application as State’s Race to the Top plans (including agreeing to implement. If a State is evidence of its LEAs’ commitment to its considerations of the numbers and awarded a Race to the Top grant, its reform plan. We are adding language in percentages of participating LEAs, participating LEAs (as defined in this criterion (A)(1)(ii) to make this clear. schools, K–12 students, and students in notice) will have up to 90 days to Changes: Criterion (A)(1)(ii) provides poverty) will translate into broad complete final scopes of work, which that participating LEAs’ commitment to statewide impact, allowing the State to must contain detailed work plans that the State’s plans may be evidenced by reach its ambitious yet achievable goals, are consistent with their preliminary an MOU or other binding agreement. overall and by student subgroup, for— scopes of work and with the State’s Comment: A few commenters stated (a) Increasing student achievement in grant application, and should include that it would be burdensome and time- (at a minimum) reading/language arts the participating LEAs’ specific goals, consuming to require MOUs between an and mathematics, as reported by the activities, timelines, budgets, key SEA and its LEAs with required NAEP and the assessments required personnel, and annual targets for key signatories, and suggested that the under the ESEA; performance measures. We have added Department allow SEAs to design and (b) Decreasing achievement gaps a new Appendix D to this notice which propose a stakeholder input process in between subgroups in reading/language provides a model MOU that States may accordance with State and local needs. arts and mathematics, as reported by the use in developing these agreements. One commenter requested clarification
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as to whether a State’s Race to the Top required to approve the State’s entire States, we have decided not to include application must include an MOU with application. it in the final notice. each LEA or whether an outline of what Discussion: The Department agrees Changes: The final notice does not ask would be covered in an MOU with an that Race to the Top plans would benefit States to provide estimates of their LEA would suffice. from input and involvement by parents, expected levels of future performance Discussion: The Department teachers, and the organizations that were they not to receive funds under acknowledges that requiring States to represent them. Thus, at the State level, this program. develop and obtain signed MOUs for criterion (A)(2)(ii) includes teachers’ Selection Criterion (A)(2)(ii): submission with Race to the Top unions, parent-teacher organizations, Stakeholder Support (proposed criterion applications on a short timeline will be and charter school membership (E)(3)): a challenge. However, strong LEA associations among the broad group of Comment: We received many participation in State Race to the Top stakeholders from which a State could comments on the list of stakeholders in plans is essential if those plans are to obtain statements or actions of support proposed criterion (E)(3) from which have a broad impact on student to demonstrate statewide commitment States could enlist support and outcomes. To assist States in this work, to its Race to the Top plan. In addition, commitment for their State plans. Many we are providing, as part of the at the LEA level, criterion (A)(1)(ii)(c) commenters welcomed the broad list of application package and Appendix D in specifies that LEA leadership support stakeholders; in particular, several this notice, a model MOU that States will be evaluated based on the number commenters expressed appreciation for can adapt or use in signing agreements of signatures gathered from among the including teachers’ unions in the list of stakeholders given the need for teacher with their participating LEAs. superintendent (or equivalent), school and school staff support to effectively With regard to the question of board president (or equivalent, if implement Race to the Top reforms. A whether a State’s Race to the Top applicable), and teachers’ union leader few commenters recommended adding application must include an MOU with (if applicable). Changes: None. principals to the list of stakeholders. each LEA or whether an outline of what Comment: Two commenters Some commenters recommended that would be covered in an MOU with an recommended removing the phrase States obtain the signature of union LEA would suffice, criterion (A)(1)(ii) ‘‘ambitious yet achievable’’ in proposed leaders on their applications, while makes clear that the MOUs included in criterion (E)(4) on the grounds that it another recommended that teachers’ a State’s application will be used as might encourage States to set a low bar unions not be given ‘‘veto power’’ over evidence of LEAs’ commitment to the and that it reflects a step backward from statewide or local plans. State’s plan. Therefore, in order to current ESEA accountability Discussion: We agree with receive maximum points on criterion requirements emphasizing 100 percent commenters that it is important for (A)(1)(ii), a State should have an MOU proficiency for all students. A number States to obtain support for their reform for each participating LEA. However, in of commenters requested that the plans from teachers and principals, and acknowledgement of the short timeline, Department provide more guidance on that this should include a State’s we are clarifying in the new expectations for State targets. teachers’ union or statewide teachers’ Participating LEA Scope of Work Discussion: We are retaining the association. As stewards of the teaching requirement that a State need only ‘‘ambitious yet achievable’’ language in workforce, teachers’ unions have a include preliminary scopes of work criterion (A)(1)(iii) (proposed criterion critical role to play in education reform. from its participating LEA in its (E)(4)). The Department believes that Therefore, in this final notice, criterion application. States will have up to 90 this language strikes the right balance (A)(2)(ii)(a) (proposed criterion (E)(3)) days after receiving a grant award to between encouraging States to set a high specifically identifies teachers and obtain the final scope of work from bar for Race to the Top goals while principals, which include a State’s participating LEAs. States also can use recognizing that real change in teachers’ union or statewide teachers’ this time to reach agreements with education is difficult and takes time. association, as stakeholders whose additional participating LEAs. The purpose of this language is to support will earn States points. Changes: We have included in encourage realistic thinking and However, we decline to require States to Appendix D to this notice a model MOU planning that connects specific obtain signatures from union leaders in that States can adapt or use for their activities to specific achievable results. order to apply for a Race to the Top LEAs who will be participating LEAs. In Further, the Department believes that Grant. addition, we have added a new the competitive aspect of the Race to the Note that for clarity, we have moved Participating LEA Scope of Work Top program will prevent States from ‘‘charter school authorizers’’ from this requirement in order to clarify that the setting low bars. list to the list in criterion (A)(2)(ii)(b), MOUs need only include a preliminary Changes: None. regarding other critical stakeholders. scope of work, which must be finalized Comment: One commenter objected to Changes: Criterion (A)(2)(ii)(a) within 90 days of the State receiving a our proposal that in responding to provides for evaluation of a State’s Race to the Top award. This proposed criterion (E)(4), regarding application based on the extent to requirement also clarifies that winning targets for improved student outcomes, which it has a high-quality plan to use States can reach agreements with States submit an estimate of the State’s the support from its teachers and additional participating LEAs within 90 expected levels of future performance principals, which include the State’s days of the State receiving a Race to the were the State not to receive Race to the teachers’ unions or statewide teacher Top award. Top funding; this commenter argued associations, to better implement its Comment: Several commenters that a State’s goal should be the same plans. requested that the MOU between the with or without additional funding. Comment: Some commenters stated State and its LEAs require the signature Another commenter requested that State plans should not include of the president of the local PTA units clarification as to how such outcomes elements that potentially undermine and State charter school membership should be estimated. collective bargaining agreements. associations. Another commenter Discussion: Because this requested Discussion: We agree with the requested that State union leaders be piece of evidence was confusing to comment that State reform plans should
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not undermine collective bargaining organizations (e.g., parent-teacher will earn points for demonstrating agreements. We also believe that Race to associations, nonprofit organizations, stakeholder support under criterion the Top may lead to forward-thinking local education foundations, and (A)(2)(ii). In addition, we note that the approaches that change how LEAs and community-based organizations); and list of proposed stakeholders in criterion teachers’ unions work together within institutions of higher education.’’ (A)(2)(ii)(b) is illustrative. We believe the framework of collective bargaining. Comment: Some commenters viewed that this list provides sufficient clarity Of course, any changes to collective proposed criterion (E)(3) as an regarding the phrase ‘‘statewide bargaining agreements must be opportunity to be involved in support’’ and, therefore, decline to collectively bargained. developing a State’s reform plan. One define it in this notice. Changes: None. commenter recommended adding Changes: None. Comment: Many commenters language to the final notice to require Comment: Some commenters recommended that other stakeholder LEA participation in the development of requested that the Department include groups be included in proposed the State plan, while another in the final notice examples of the criterion (E)(3) as groups from which commenter proposed that States specific kinds of evidence that should States should obtain support and develop their plans in consultation with be used to demonstrate stakeholder commitment for their State plans. civil rights leaders, parents, and support. For example, one commenter Commenters recommended that the community groups that are suggested that evidence of support following groups be included: State representative of the State’s population, should include strong letters of legislatures, charter school associations, and document such consultation. Other commitment from teachers’ unions; parent and family organizations, parent- commenters recommended that the another commenter suggested that teacher associations, Parent Information Department award additional points for States provide documentation that plans and Resource Centers, youth-serving State plans that coordinate and integrate were developed with stakeholder community-based organizations (CBOs) support from education, health, support. and other community groups, CBOs nutrition, social services, and juvenile Discussion: We agree that it would be serving Native American tribes, higher justice stakeholders, or for helpful to specify the evidence that a education leaders and providers, demonstrating a broad spectrum of State should submit to demonstrate the members of the business community, stakeholder support. strength of its support from a broad private and faith-based school leaders, Discussion: There is no requirement range of stakeholders. To give further students, local education funds, value- that a State involve its LEAs, or any guidance as to how States should added intermediaries, public other persons or groups, in developing respond to this criterion, we are revising broadcasting entities, municipal leaders, its reform plan. However, given that the teachers and principals who have success of a State’s plan depends, to a criterion (A)(2)(ii) to clarify that successfully turned around schools, large extent, on the support and reviewers will judge the extent to which school service providers, guidance commitment of its LEAs to implement a State has a high-quality plan to use its counselors, statewide after-school the plan, we strongly encourage States stakeholder support to better implement networks, and statewide teacher to work together with their LEAs in its Race to the Top plans, as evidenced associations. developing their State plan. Similarly, by the strength of its stakeholders’ Discussion: We appreciate the broad we believe that committed and statements or actions of support. We are and diverse group of stakeholders that interested stakeholders can make the also clarifying in Appendix A to this commenters identified as important to difference in a reform’s success or notice that States should provide the States’ reform efforts. Obviously, the failure. We decline to require States to key statements or actions of support and stakeholders from which a State should develop their plans with any specific a summary of them in their garner support for its reform plan will stakeholders or to award additional applications. vary based, to a large extent, on the points for plans that coordinate with Changes: We have added to the unique needs of the State and its LEAs. specific groups or agencies, as introduction in criterion (A)(2)(ii), the While we cannot include all of the recommended by commenters. We following: ‘‘Use support from a broad stakeholders recommended by believe the decision on who to work group of stakeholders to better commenters in this notice, we believe it with in developing a State plan is best implement its plans, as evidenced by is important to include several examples left to States. the strength of the statements or actions for illustrative purposes and to Changes: None. of support from—.’’ We have changed encourage States, as appropriate to their Comment: A number of commenters the requested evidence in Appendix A unique contexts, to solicit broad expressed concern that requiring to require that States provide ‘‘a support. We are, therefore, designating support or input from a broad range of summary in the narrative of the proposed criterion (E)(3)(ii) as criterion stakeholders could lead to less rigorous, statements or actions and inclusion of (A)(2)(ii)(b), and adding ‘‘charter school ‘‘watered-down’’ plans if States were to key statements or actions in the authorizers’’ from proposed criterion satisfy all the different groups with their Appendix’’ when responding to this (E)(3)(i), as well as additional competing interests. Some of these criterion. stakeholders from whom the State may commenters recommended eliminating Selection Criterion (A)(2): Building want to obtain support for its plans. the provision on stakeholder support State Capacity (proposed criterion Changes: Criterion (A)(2)(ii)(b) reads from the final notice, while others (E)(5)): as follows: ‘‘Other critical stakeholders, suggested clarifying that ‘‘buy-in’’ from Comment: A number of commenters such as the State’s legislative all stakeholders is not required. Several expressed support for criterion (A)(2) leadership; charter school authorizers commenters requested a definition of (proposed criterion (E)(5)), which and State charter school membership ‘‘statewide support.’’ focuses on a State’s plan to build associations (if applicable); other State Discussion: Race to the Top does not statewide capacity to implement, scale and local leaders (e.g., business, require States to work with specific up, and sustain its reform plan. One community, civil rights, and education stakeholders (other than LEAs) or obtain commenter in particular emphasized the association leaders); Tribal schools; their support and commitment in order importance of plan implementation. parent, student, and community to be eligible for a grant. Instead, States This commenter claimed that States
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often make empty promises and fail to effectiveness, ceasing ineffective resources to meet targets and perform deliver on their grant applications. practices, widely disseminating and related functions. In this notice, we Discussion: We agree that the Race to replicating the effective practices have retained that application the Top competition must judge States’ statewide, holding participating LEAs requirement (re-designated as capabilities to implement their plans, as (as defined in this notice) accountable application requirement (c)), but also well as the quality of the plans for progress and performance, and included language in criterion themselves. To emphasize this point, we intervening where necessary.’’ (A)(2)(i)(d) directing reviewers to are moving most of the criteria in Comment: Some commenters evaluate how the State will use its Race proposed criterion (E)(5) to criterion suggested that the Department require to the Top funds to accomplish its plans (A)(2)(i), in which the Department will coordination between State agencies and meet its targets. We also note that, evaluate the extent to which a State has and education-related organizations, for under section 14006(c) of the ARRA, a high-quality plan to ensure it has the example, to share and scale up the States must subgrant at least 50 percent capacity necessary to implement its adoption of successful Race to the Top of their Race to the Top grant to proposed Race to the Top plans. We are strategies. Other commenters requested participating LEAs based on LEAs’ adding a criterion regarding State clarification regarding the collaboration relative shares of funding under Part A, leadership. We are also including in contemplated by the Department in Title I of the ESEA. In addition, States criterion (A)(2)(i)(c) (proposed (E)(5)(i)) proposed criterion (E)(5)(iv), which have considerable flexibility in more specific examples of activities that would examine the quality of a State’s awarding or allocating the remaining 50 support effective and efficient grant plan to collaborate with other States on percent of their Race to the Top awards, administration, such as budget reporting key elements of a State’s application. which are available for State-level and monitoring, performance measure Another commenter suggested that the activities, disbursements to LEAs, and tracking and reporting, and fund Department strengthen this other purposes as the State may propose disbursement. collaboration requirement. in its plan. Changes: Criterion (A)(2)(i)(a) has Discussion: We agree that States and Changes: Criterion (A)(2)(i)(d) been added to address the extent to LEAs should partner with and learn provides for the evaluation of the extent which a State has a high-quality plan to from outside organizations, other to which the State has a high-quality provide strong leadership and dedicated agencies, and other States and LEAs plan for using the funds for this grant, teams to implement the statewide whenever doing so would help them as described in the State’s budget and education reforms plans the State has improve student outcomes. However, accompanying budget narrative, to proposed. Criterion (A)(2)(i)(c) commenters’ confusion over the accomplish the State’s plans and meet incorporates with minor changes the Department’s intentions around its targets, including, where feasible, by language from proposed criterion collaboration convinced us that coordinating, reallocating, or (E)(5)(i) and now reads: ‘‘Providing reviewers would be best able to reliably repurposing education funds from other effective and efficient operations and score State applications if collaboration Federal, State, and local sources so that processes for implementing its Race to were evaluated in the context of specific they align with the State’s Race to the the Top grant in such areas as grant plans rather than as a stand-alone Top goals. administration and oversight, budget portion of a State’s application. In other Comment: A number of commenters reporting and monitoring, performance words, to the extent that a State expressed concern regarding proposed measure tracking and reporting, and improves the quality of its plan in criterion (E)(5)(v), which focuses on the fund disbursement.’’ response to a given criterion by extent to which States coordinate, Comment: Some commenters collaborating with others, the State will allocate, or repurpose funds from other supported proposed criterion (E)(5)(ii) receive credit under that criterion for sources to align with the State’s Race to and its focus on ensuring the having a high-quality plan. In addition, the Top goals. One commenter dissemination of best practices. in situations where there is especially suggested that it was beyond the scope Discussion: We agree that supporting clear value to collaboration among of the Race to the Top program to LEAs to implement the State’s reform States, such as in the development of suggest that non-ARRA funds be plans and disseminate successful common standards and assessments (see reallocated to meet the goals of the Race practices is critical to a State’s reform criteria section B), we have specifically to the Top program. A number of efforts. Therefore, we are re-designating encouraged collaboration. We have commenters requested that the proposed criterion (E)(5)(ii) as criterion therefore removed from this notice the Department add the phrase ‘‘consistent (A)(2)(i)(b) and adding examples of State more general criterion on collaboration with program requirements’’ after activities that will help LEAs (proposed criterion (E)(5)(iv)). proposed criterion (E)(5)(v) to ensure successfully implement reform plans, Changes: We have removed proposed that reallocation of funds does not such as identifying promising practices, criterion (E)(5)(iv), regarding violate the program requirements of the evaluating the effectiveness of these collaboration with other States, from IDEA. practices, ceasing ineffective practices, this final notice. Discussion: In response to concerns and widely disseminating and Comment: Some commenters raised by many commenters regarding a replicating effective practices. emphasized the need for States to State’s ability or authority to repurpose Changes: We have re-designated ensure that LEAs have sufficient education funds from other sources to proposed criterion (E)(5)(ii) as criterion resources to implement reforms. align with a State’s Race to the Top (A)(2)(i)(b) and added additional text for Discussion: We agree with the plan, we are adding ‘‘where feasible’’ in clarity and completeness. Criterion commenters that LEA activities are proposed criterion (E)(5)(v). We also are (A)(2)(i)(b) now reads as follows: central to Race to the Top and that LEAs re-designating proposed criterion ‘‘Supporting participating LEAs (as will need sufficient resources to make (E)(5)(v) as criterion (A)(2)(d) and defined in this notice) in successfully their activities a success. In the NPP, adding additional text for clarity and implementing the education reform proposed application requirement (e) completeness. However, we continue to plans the State has proposed, through required a State to include a budget that believe that States need to focus and such activities as identifying promising detailed, among other things, how it align their education funding resources practices, evaluating these practices’ would use grant funds and other for maximum impact consistent with
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existing program requirements, and that generally, proposed criterion (E)(1)(ii) achievement of students with Race to the Top should encourage States asked States to describe how they have disabilities. Another commenter noted to leverage the improved use of all used ARRA and other Federal and State that the NAEP does not include high available resources, regardless of the funding to pursue reforms in these school results. Others expressed source, to support effective, areas, and proposed criterion (E)(1)(iv) concern that using the NAEP data comprehensive changes in State and asked States to describe the successes would only encourage teaching to a test local education systems. In this context, they have had in increasing student or would conflict with the NAEP’s consideration of the extent to which a achievement, closing achievement gaps, purpose as an outside and valid State is willing to realign available and increasing graduation rates. In order measurement. Several commenters resources in support of Race to the Top to reduce redundancy and the burden stated that, in addition to the NAEP, the goals is not only appropriate, but on States, we are combining proposed Department should allow States to necessary. criteria (E)(1)(i) and (E)(1)(ii) into one demonstrate achievement gains on Changes: We have re-designated criterion and designating it as criterion assessments or achievement measures criterion (E)(5)(v) as criterion (A)(2)(d) (A)(3)(i). We are also designating under the ESEA, such as the annual and clarified that States will be judged proposed criterion (E)(1)(iv) as criterion proficiency scores and targets used to based on their coordination, (A)(3)(ii). Both of these revised criteria determine adequate yearly progress reallocation, or repurposing of are now part of the State Success (AYP), including proficiency rates education funds so that they support Factors section. We believe this broken down by subgroup. One Race to the Top goals ‘‘where feasible.’’ reorganization more logically groups our commenter stated that it would be Comment: One commenter requests for information regarding particularly unfair to require a State to recommended amending proposed progress. We have also added, in use NAEP data where the State could criterion (E)(5)(iii) to include fiscal criterion (A)(3)(ii), that States may demonstrate that it has more rigorous resources, rather than ‘‘economic report progress since ‘‘at least’’ 2003 to assessments. Other commenters resources’’ in the list of resources that allow a longer data history for States suggested the final notice permit States States should use to continue Race to that have such data (all States have to include other measures to the Top reforms after the grant funding. NAEP and ESEA data since 2003, but demonstrate achievement gains. Another commenter recommended not all States participated in all of NAEP Discussion: The Department proposed clarifying that grant activities should be prior to 2003). Further changes to using NAEP results to measure State continued only if there is evidence of criterion (A)(3)(ii) are discussed later in progress in increasing student success. this section. achievement and decreasing Changes: We have combined Discussion: We agree that ‘‘fiscal’’ is achievement gaps because NAEP is the proposed criteria (E)(1)(i) and (E)(1)(ii) a better word than ‘‘economic’’ to only national measure of student into one criterion, designated (A)(3)(i), describe the financial resources that a achievement that is comparable across and designated proposed criterion State will use to continue Race to the States. The limitations of the NAEP, as (E)(1)(iv) as criterion (A)(3)(ii). Criterion Top reforms after the period of Race to pointed out by commenters, are well- (A)(3) now evaluates a State based on the Top funding has ended. Therefore, known: It is not aligned to State content the extent to which the State has we are changing proposed criterion standards, does not include high school demonstrated its ability to— (E)(5)(iii) to refer to fiscal resources and results, and may not provide accurate re-designating criterion (E)(5)(iii) as (i) Make progress over the past several years in each of the four education achievement information for students criterion (A)(2)(i)(e). In addition, we are with disabilities and certain other adding language to criterion (A)(2)(i)(e) reform areas, and used its ARRA and other Federal and State funding to subgroups. Also, the NAEP is not to clarify that post-Race to the Top grant administered annually, limiting the planning applies only to continuing pursue such reforms; (ii) Improve student outcomes overall number of data points available for support for Race to the Top activities for measuring progress toward Race to the which there is evidence of success. and by student subgroup since at least 2003, and explain the connections Top goals. However, the ability of NAEP Changes: We have re-designated to compare progress across States and to proposed criterion (E)(5)(iii) as criterion between the data and the actions that have contributed to— be a consistent measure over time (A)(2)(i)(e) and revised the criterion to remains a compelling reason to use it for read as follows: ‘‘Using the fiscal, (a) Increasing student achievement in reading/language arts and mathematics, Race to the Top. Accordingly, we political, and human capital resources believe that including data from both of the State to continue, after the period both on the NAEP and on the assessments required under the ESEA; the NAEP and the annual State of funding has ended, those reforms assessments required under the ESEA funded under the grant for which there (b) Decreasing achievement gaps between subgroups in reading/language will provide a more complete and valid is evidence of success.’’ picture of State progress to date and Selection Criterion (A)(3): arts and mathematics, both on the NAEP States’ goals for increasing student Demonstrating Significant Progress in and on the assessments required under achievement and decreasing Raising Achievement and Closing Gaps the ESEA; and achievement gaps. We are incorporating (proposed criteria (E)(1) and (E)(4)): (c) Increasing high school graduation rates. with some revisions the language from Note: This section includes issues common Comment: A number of commenters proposed criteria (E)(1)(iv) and (E)(4) to criteria (A)(1)(iii) and (A)(3)(ii). objected to our proposal that States into criteria (A)(3)(ii) and (A)(1)(iii) to Comment: None. demonstrate progress in increasing reflect this decision. In addition, we are Discussion: The ARRA emphasizes student achievement and closing the specifying in application requirement the importance of States demonstrating achievement gap using the National (g) that when describing data for the significant progress in meeting the Assessment of Educational Progress assessments required under the ESEA, objectives of the four assurance areas. In (NAEP). Some of these commenters the State should note any factors (e.g., the NPP, proposed criterion (E)(1)(i) asserted that the NAEP provides an changes in cut scores) that would asked States to describe their progress in incomplete and distorted view of impact the comparability of data from each of the four education reform areas student achievement, particularly the one year to the next. We also note that
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including more than one assessment to be college- and career-ready, and in an institution of higher education. should significantly reduce any risks of increases in the percentage of low- We have also added a definition of teaching to the test. As a result, we do income and minority students being college enrollment, which refers to the not believe that including this use of the taught by effective teachers. Other enrollment of students who graduate NAEP in Race to the Top will affect commenters recommended the addition from high school consistent with 34 NAEP’s validity or utility as an objective of targets for early childhood education, CFR 200.19(b)(1) and who enroll in an measure of student achievement, as such as goals for kindergarten readiness institution of higher education (as suggested by commenters. and third-grade reading and defined in section 101 of the Higher Regarding the comment that we mathematics. A few commenters Education Act, Public Law 105–244, 20 should allow States to demonstrate suggested that in evaluating Race to the U.S.C. 1001) within 16 months of achievement gains on assessments or Top applications, the Department graduation. achievement measures under the ESEA, consider the extent to which a State has Comment: Many commenters such as the annual proficiency scores ambitious annual targets for increasing requested that the Department ensure and targets used to determine AYP, we college enrollment and completion rates that State applicants set targets for all note that States already issue annual or increasing college and career core academic subjects reported by the reports on AYP status for schools and readiness. NAEP, and not only in reading and LEAs, including proficiency rates for all Discussion: The Department mathematics, as in proposed criteria schools; there is no need to duplicate acknowledges that many measures (E)(4)(i) and (ii). this reporting by requiring its inclusion could demonstrate progress toward Race Discussion: The final notice continues in a State’s annual Race to the Top to the Top goals. We especially agree to focus on reading and mathematics report. However, States that desire to that increasing college enrollment is an achievement, partly to ensure include AYP data (or other measures) in important area that should be reviewed consistency with ESEA assessment their annual Race to the Top reports in the context of Race to the Top. We requirements and partly to promote would be free to do so. are, therefore, adding criterion comparability, since all States have Changes: Proposed criteria (E)(1)(iv) (A)(1)(iii)(d), which examines the extent NAEP and ESEA assessment results and (E)(4) have been redesignated as to which a State’s LEA participation dating back to at least 2003 in those criteria (A)(3)(ii) and (A)(1)(iii), will allow the State to reach its subjects. The Department notes, respectively. They have been revised to ambitious yet achievable goals for however, that these are minimum consider both NAEP and ESEA increasing college enrollment and credit expectations; States may include assessment results when evaluating accumulation. We are also adding a assessment results in other subjects both increases in student achievement and definition of college enrollment to help to demonstrate past progress and to decreases in achievement gaps in States respond appropriately to this measure Race to the Top performance reading/language arts and mathematics; criterion. going forward. criterion (A)(3)(ii) considers these in After careful consideration of the terms of historic gains (since at least comments, the Department believes that Changes: None. 2003), while criterion (A)(1)(iii) this new criterion, in combination with Comment: Many commenters considers them in terms of future goals the proposed measures—which focus on recommended that States focus more in light of the participation of the State’s reading, mathematics, and increasing narrowly on specific student groups in LEAs in the State’s reform plans. The graduation rates—reflect the right crafting their State Plans to raise student evidence requested in Appendix A has emphasis on key areas that States can achievement and close achievement also been revised to conform with the report on with some validity and gaps, including among high-need criteria. We have also added application comparability. Further increasing the students. requirement (g), which we discuss in number of measures would increase Discussion: We agree with the more detail later in this notice. data collection and reporting burdens commenters that closing achievement Comment: Many commenters on States and LEAs, many of which gaps is an urgent national priority. recommended modifications or have not been collecting data in the Proposed criterion (E)(4) asked States to additions to the achievement measures areas suggested by commenters. States set ambitious yet achievable goals for for assessing past progress and setting that want to include their own closing achievement gaps, as well as for future targets in proposed criteria supplemental measures and targets are increasing student achievement and (E)(1)(iv) and (E)(4). Other commenters free to do so, and the ongoing expansion graduation rates overall and by supported the NPP’s emphasis on of State data systems, which is subgroup. Criterion (A)(1)(iii) in this increasing student achievement, supported by the Race to the Top final notice retains these provisions and narrowing achievement gaps, and program and encouraged under includes similar subgroup-specific goals increasing graduation rates. One key invitational priority 4, will likely in new criterion (A)(1)(iii)(d), regarding area of concern for several commenters facilitate future indicators and targets in college enrollment and credit was dropout recovery and prevention, such areas as early childhood, drop-out accumulation. This final notice also with one commenter recommending prevention, and student mobility. includes new language in criterion that the Department supplement Changes: We have added criterion (A)(3)(ii) specifying that States’ recent existing measures on graduation rates in (A)(1)(iii)(d), which rewards States gains in increasing student achievement proposed criteria (E)(1)(iv) and (E)(4)(iii) whose LEA participation will translate and graduation rates will be evaluated with targets for decreasing the number into broad statewide impact, allowing both overall and by student subgroup. of young people aged 18 to 24 without the State to reach its ambitious yet We leave it to States to determine which a high school diploma. Other achievable goals, overall and by student of the subgroups in their student commenters recommended that States subgroup, for increasing college populations need the most attention. set targets and report on the percentage enrollment (as defined in this notice) Changes: Criterion (A)(3)(ii) rewards of low-income and minority 9th grade and increasing the number of students States that have demonstrated the students who graduate from high school who complete at least a year’s worth of ability to improve student outcomes in four years, the number of low-income college credit that is applicable to a overall and by student subgroup since at and minority students who are on track degree within two years of enrollment least 2003 and explain the connections
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between the data and the actions that (1) For student subgroups with Selection Criterion (B)(1): Developing have contributed to— respect to the NAEP, the State must and adopting common standards (a) Increasing student achievement in provide data for the NAEP subgroups (Proposed Selection Criterion (A)(1)): reading/language arts and mathematics, described in section 303(b)(2)(G) of the Comment: Commenters were divided both on the NAEP and on the National Assessment of Educational in their reactions to the criterion under assessments required under the ESEA; Progress Authorization Act (i.e., race, which the Department would evaluate (b) Decreasing achievement gaps ethnicity, socioeconomic status, gender, States’ applications based on their between subgroups in reading/language disability, and limited English commitment to adopt a common set of arts and mathematics, both on the NAEP proficiency). The State must also K–12 standards (as defined in this and on the assessments required under include the NAEP exclusion rate for notice). Many commenters supported the ESEA; and students with disabilities and the this criterion. Some suggested (c) Increasing high school graduation exclusion rate for English language procedures that should be followed in rates. learners, along with clear the process of developing standards, Comment: A number of commenters documentation of the State’s policies including the need for broad suggested that the Department should and practices for determining whether a participation from representatives of all not ask States to report data student with a disability or an English student subgroups within a State prior disaggregated by the student subgroups language learner should participate in to formal adoption of standards. A few commenters, however, were in section 303(b)(2)(G) of the NAEP but the NAEP and whether the student opposed to the adoption of common rather use the student subgroups as needs accommodations; standards for various reasons, such as a described in section 1111(b)(2)(C)(v)(II) (2) For student subgroups with lack of evidence that common standards of the ESEA. Others emphasized the respect to graduation rates, college will benefit students and the potential importance of disaggregating data by enrollment and credit accumulation cost of adopting new content standards. subgroup, including race and gender. rates, and the assessments required under the ESEA, the State must provide One commenter urged removing Discussion: We agree with the need to participation in a consortium as a clarify the subgroups for which States data for the subgroups described in section 1111(b)(2)(C)(v)(II) of the ESEA necessary condition of funding because must report achievement data given the of concerns that the size and the (i.e., economically disadvantaged differences in reporting achievement complexity of the relationships in a students, students from major racial and data by subgroups under the NAEP consortium may have the potential for ethnic groups, students with versus under the ESEA. As discussed conflicts of interest. Some commenters disabilities, and students with limited earlier, we are adding new paragraph (g) regarded the proposed criterion as English proficiency); and in the application requirements that punitive. A few commenters suggested explains the subgroup data that a State (3) When asked to provide making participation in common must provide in various parts of the information regarding the assessments standards an invitational priority in the application. Specifically, when required under the ESEA, States should interest of making adoption truly addressing items in the criteria for refer to section 1111(b)(3) of the ESEA; voluntary. Another commenter student subgroups with respect to the in addition, when describing this expressed concern that a criterion under NAEP, the State must provide data assessment data in the State’s which States would be rewarded for using the NAEP subgroups as described application, the State should note any their commitment for adopting a in section 303(b)(2)(G) of the National factors (e.g., changes in cut scores) that common set of K–12 standards will Assessment of Educational Progress would impact the comparability of data preempt what, up to now, has been a Authorization Act (20 U.S.C. 9622) (i.e., from one year to the next. State-led process and would call into race, ethnicity, socioeconomic status, Comment: One commenter question the voluntary nature of State gender, disability, and limited English recommended that the Department adoption of standards. proficiency); and when addressing items clarify that States must still meet AYP Many commenters argued that States in the criteria for student subgroups targets as required by the ESEA, even as should be excused from the requirement with respect to high school graduation they set new targets based on NAEP to adopt common core standards if their rates, college enrollment and credit scores for Race to the Top accountability current standards are as rigorous as accumulation rates, and the assessments purposes. Another expressed concern common standards. One commenter required under the ESEA, the State must that these criteria would tie State suggested that the Department include provide data for the subgroups accountability goals and reporting to in the final notice an additional described in section 1111(b)(2)(C)(v)(II) NAEP, which would conflict with ESEA criterion to provide recognition for of the ESEA (i.e., economically requirements that link accountability to those States with rigorous standards and disadvantaged students, students from State-based standards and assessments. improved student achievement. Another major racial and ethnic groups, students Discussion: The Department does not recommended an external review with disabilities; and students with believe that additional language is focused on rigor, college and career limited English proficiency). We note required to clarify that States must still readiness and international that States are required under section meet existing ESEA requirements. benchmarking to determine whether 1111(b)(3)(C)(xiii) of the ESEA to also Neither the ARRA nor this final notice adoption of a common set of K–12 report achievement data disaggregated affects States’ compliance with and standards is necessary. by gender and migrant status. obligations under the ESEA. Discussion: We appreciate Changes: As discussed earlier, we Changes: None. commenters’ support for this criterion. have added new paragraph (g) in the The Department believes that States’ B. Standards and Assessments application requirements, which adoption of common sets of K–12 specifies that when addressing issues Definitions: Common set of K–12 standards will provide a foundation for related to assessments required under standards and high-quality assessment. more efficient and effective creation of the ESEA or subgroups in the selection Comments regarding the preceding the instructional and assessment criteria, the State must meet the definitions are addressed, as resources needed to implement a following requirements: appropriate, below. coherent system of teaching and
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learning. We do not agree that an consortia that have defined or adopted the Scoring Rubric (see Appendix B) so external review is needed to determine common standards. One commenter that, on this aspect of the criterion, a whether States’ adoption of common K– requested recognition of the national State will earn ‘‘high’’ points if its 12 standards is necessary. collaborative of State leaders developing consortium includes a majority of the Some readers appear to have been national standards and assessments in States in the country, and ‘‘medium’’ or confused about the role of the criteria. arts education. ‘‘low’’ points if its consortium includes One mistakenly believed that joining a Discussion: In this program, the one-half of the States in the country or consortium was a condition of funding phrase ‘‘common standards’’ does not less. Additionally, we have added a under Race to the Top. This is not the refer to any specific set of common reference to this in criterion (B)(1) by case. Criteria are used to evaluate grant standards, such as the common core adding the parenthetical ‘‘(as set forth in applications and applicants. States standards currently under development Appendix B)’’ after ‘‘evidenced by.’’ receive points for the strength and by members of the National Governors Comment: Many commenters content of their responses to the criteria. Association and the Council of Chief expressed concern regarding the In this program, we proposed that State School Officers. The Department proposed timeline for the adoption of States’ applications would be evaluated declines to make changes in order to common standards by June 2010. and receive points for demonstrating endorse any particular standards- Commenters urged delay of the their commitment to improve standards development consortium. adoption target date in order to allow by participating in a consortium of Changes: None. adequate time for activities such as local States working toward jointly adopting Comment: Several commenters review and evaluation of the common common K–12 standards. Thus, States recommended that we clarify the standards, legislative or administrative with stronger proposals would receive meaning of ‘‘a significant number of action required for adoption, and broad more points; however, a State could States’’ within a consortium. One stakeholder participation. Several receive a grant even without getting any recommended that the number of States pointed out that the proposed timeline points for this criterion. An individual be set at a minimum of three if the for adoption of common standards by State that chooses not to participate in quality of their common standards is June 2010 conflicts with the timeline a consortium for the development and comparable to the common standards agreed to by governors and State chiefs adoption of common standards is developed by members of the National currently participating in one eligible to apply for funds, but the Governor’s Association and the Council consortium for the development of application will not receive points of Chief State School Officers. Others common standards. One commenter under this criterion. A State that suggested that instead of a minimum objected that the Race to the Top chooses not to join a consortium could number, the criterion should focus on process does not allow States enough describe its accomplishments in the importance or potential impact of time to review the final standards from response to new criteria (F)(3) under the proposed work. that consortium before submitting a which it could earn points for other Discussion: The goal of common K–12 grant application. Others questioned significant reform conditions that have standards is to replace the existing apparent differences for Phase 1 contributed to increased student patchwork of State standards that applicants and Phase 2 applicants achievement, narrowed achievement results in unequal expectations based on regarding the actual adoption of gaps, or other important outcomes. We geography alone. Some of the major common standards. decline to make participation in benefits of common standards will be Discussion: The Department common standards an invitational the shared understanding of teaching recognizes that States need as much priority for which a State would receive and learning goals; consistency of data time as possible to review, evaluate, and no points in the competition, rather permitting research on effective adopt common K–12 standards. We are than a selection criterion. We believe practices in staffing and instruction; and therefore extending the deadline for that common internationally the coordination of information that adopting standards as far as possible, benchmarked standards that prepare could inform the development and while still allowing the Department to students for college and careers are a implementation of curriculum, comply with the statutory requirement critical foundation for students’ instructional resources, and professional that the Department obligate all Race to education and, therefore, are a development. The Department believes the Top funds by September 30, 2010. component of a State’s application that the cost savings and efficiency The new deadline in this criterion for deserving of evaluation and points in resulting from collaboration in a adopting common K–12 standards is the competition. consortium should be rewarded through August 2, 2010, or, at a minimum, by a We agree that there is potential for the Race to the Top program when the later date in 2010 specified by the State. conflicts of interest to arise within impact on educational practices is As described in the Scoring Rubric, consortia, but believe there are ways for pronounced. And generally, we believe States that meet the August 2, 2010 consortia to mitigate such conflicts and that the larger the number of States target date will earn more points for this that removal of the criterion on these within a consortium, the greater the criterion; a State that has a high-quality grounds is not warranted. benefits and potential impact. We plan to adopt common standards by a Changes: None. decline to define the term ‘‘significant later date in 2010 will earn some points Comment: Several commenters number of States’’ by providing a for this criterion. In addition, we have recommended that the Department particular number of States. We are clarified that Phase 1 applicants must clarify in the final notice whether the providing additional information in demonstrate commitment to and reference to common standards refers Appendix B regarding how this progress toward adoption by August 2, specifically to the common core selection criterion will be scored by 2010, or, at a minimum, by a later date standards currently being developed reviewers and adding a cross reference in 2010 specified by the State, and that jointly by members of the National to Appendix B in criterion (B)(1) to Phase 2 applicants must demonstrate Governors Association and the Council emphasize that States’ evidence will be adoption by that date in order to earn of Chief State School Officers. Others evaluated using Appendix B. the most points for this criterion. We recommended that the guidelines be Changes: The term ‘‘significant understand that adoption of standards is modified to recognize other multi-State number of States’’ has been clarified in a legal process at the State level, and
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fully expect that implementation of the State should provide whatever evidence that many kinds of documentation standards will follow a thoughtful, it believes is appropriate to demonstrate could reasonably support the claim that deliberate course in subsequent year(s). its efforts to address this criterion. common standards build toward college For any State receiving funds, the Changes: We have clarified some of and career readiness and prefers to leave Department will monitor the State’s the requested evidence for criterion the selection of appropriate progress in meeting its goals and (B)(1). We request that a State supply a documentation to the States. timelines as established in its plan, copy of the Memorandum of Agreement, Changes: None. executed by the State, showing that it is including States’ progress towards Definition of Common Set of K–12 part of a standards consortium, and adoption of common standards. Standards Changes: We have revised the provide the number and names of States deadline in criterion (B)(1) regarding participating in the consortium. A State Comment: We received several adoption of a common set of K–12 should provide a copy of the final recommendations to modify the standards. Phase 1 applicants will be standards, or if the standards are not yet definition of common set of K–12 evaluated based on their high-quality final, a copy of the draft standards and standards. Some commenters suggested plans demonstrating commitment to and anticipated date for completing the that the definition of common set of progress toward adopting a common set standards. A State should also provide K–12 standards should refer to 21st of K–12 standards by August 2, 2010, or, documentation that the standards are or century skills; English language at a minimum, by a later date in 2010 will be internationally benchmarked. proficiency standards aligned to the specified by the State. Phase 2 For Phase 1, States must provide a language arts standards; and standards applicants will be evaluated based on description of the legal process in the for science, technology, and whether they adopt such standards by State for adopting standards, and the engineering. Another commenter August 2, 2010, or at a minimum, by a State’s plan, current progress, and recommended expanding the definition later date in 2010 specified by the State timeframe for adoption. For Phase 2, to include standards currently shared in a high-quality plan toward which the States must show evidence that they across States, such as the American State has made significant progress. have adopted the standards; or, if the Diploma Project standards or ACT Both Phase 1 and Phase 2 applicants State has not yet adopted the standards, College Benchmarks. Other commenters will also be evaluated on their provide a description of the legal recommended that the definition clearly commitment to implementing the process in the State for adopting specify whether the common standards standards after the deadline in a well- standards, and the State’s plan, current should include standards for each high planned way. progress, and timeframe for adoption. school grade or for each high school We also have revised and reorganized States may provide additional evidence course. One commenter asked if the criterion (B)(1) non-substantively for beyond that requested. term ‘‘standard’’ refers to a broad purposes of clarity. When describing Comment: One commenter asked statement about content or to a discrete how a State can demonstrate its what national and international concept or skill. commitment to developing standards benchmarks are required under criterion Discussion: It is up to States we have changed the phrase, (B)(1). participating in the development of ‘‘improving the quality of its standards’’ Discussion: The Department is not common standards to determine the to ‘‘adopting a common set of high- requiring that common standards content and scope of the standards, quality standards, as evidenced by adopted by State applicants be whether to organize the standards for * * *’’. In criterion (B)(1)(ii)(a), we also benchmarked to particular international high school by grade or by course, and have removed the qualifier to a common standards, but the standards should be whether the statement of each standard set of K–12 standards (‘‘that are supported by evidence that they are is focused broadly on general concepts internationally benchmarked and that internationally benchmarked. or narrowly on particular skills. build toward college and career Changes: We have revised criterion Therefore, we decline to make the readiness by the time of high school (B)(1)(i) to clarify that the K–12 changes recommended by the graduation * * *’’) because it is standards adopted by the State should commenters. redundant with similar language in be ‘‘supported by evidence that they Changes: None. criterion (B)(1)(i)(a). are’’ internationally benchmarked. Comment: Commenters requested Comment: Several commenters Comment: A few commenters clarification of what it means for the recommended that the Department requested more detail regarding the common standards to be ‘‘identical’’ clarify in the final notice the evidence desired characteristics of college and across all States in a consortium given necessary for criterion (B)(1), asking career ready standards. Some suggested that a State may supplement the whether participation in a standards that the Department require specific common standards with additional development consortium or an types of evidence to meet this criterion, standards. Some commenters suggested expression of intent to participate in such as measurement of the skills changing the definition to refer to such a consortium, such as a needed to succeed in non-remedial standards that are ‘‘aligned,’’ across Memorandum of Agreement, is college courses, validation by the States, rather than ‘‘identical.’’ Other sufficient. One commenter suggested postsecondary system or involvement of commenters suggested that the that a State should be allowed to postsecondary faculty in development additional standards adopted by a State provide whatever evidence it believes is of the standards and assessments. should be more stringent than the appropriate to demonstrate its efforts to Discussion: Criterion (B)(1) focuses on common standards, foster innovation, or address this criterion. States’ development and adoption of focus on particular skills of local Discussion: We agree that the common K–12 standards that build relevance. evidence for this criterion should be toward college and career readiness. By Discussion: Some commenters clearer, and have made some revisions using these terms, we mean that the appeared to be confused by the term to the evidence requested for that standards should build on content ‘‘identical’’ when it was qualified by the purpose. The evidence requested is knowledge and skills regarded as possible addition of a supplementary shown in Appendix A of this notice. We essential for success in college and the group of standards that could vary do not agree with the commenter that a workforce. The Department recognizes across States in a consortium. The term
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‘‘identical’’ refers to the common could produce alone. Significant consideration of the number and standards and not the supplementary improvement of student outcomes can diversity of students in participating standards and would not permit the be realized when high-quality States, or the ability of participating standards to be ‘‘aligned’’ across States assessments aligned to common States to serve as exemplars for in a consortium, as recommended by standards inform and support teacher statewide reform, rather than focus on one commenter. Upon further reflection, instruction and, thus, student learning. the number of participating States. we believe that there may be reasons for An individual State that chooses not to Discussion: The Department believes the common standards to be slightly participate in a consortium for the that the cost savings and efficiency different across States (e.g., States may development and adoption of resulting from collaboration in a use slightly different terms to refer to assessments aligned to common consortium should be rewarded through the same concepts or may have a standards is eligible to apply for funds, Race to the Top when the impact on particular format which would require but the application will not receive educational practices is pronounced. slight changes in language) and points for this criterion. Generally, we believe that the larger the therefore, are changing ‘‘identical’’ to We understand commenters’ concerns number of States within a consortium, ‘‘substantially identical.’’ The about the overemphasis of standardized the greater the benefits and potential Department believes that it is testing, but believe that educators need impact. While the other measures unnecessary to include in the definition good information about what students suggested by the commenters could be additional requirements for the know and can do so that they can guide valuable, they would not be as objective supplementary standards, such as being their students’ learning, and adjust and a measure for the reviewers to consider more rigorous or fostering innovation, differentiate their instruction when evaluating a State’s plan. We are and therefore, declines to change the appropriately. This information needs to providing information about the scoring definition as requested by commenters. come, in part, from academic of this criterion in the Scoring Rubric Changes: We have changed assessments. set forth in Appendix B. Additionally, ‘‘identical’’ to ‘‘substantially identical’’ With respect to support for local we are adding a cross reference to to clarify that a common set of K–12 assessments, criteria (B)(3) and (C)(3) Appendix B in criterion (B)(2) to standards are ‘‘substantially identical’’ provide opportunities for focus on local emphasize that States’ evidence will be across all States in a consortium. assessments and instructional evaluated using Appendix B. Selection Criterion (B)(2): Developing improvement systems. Criterion (B)(3) Changes: The term ‘‘significant and Implementing Common, High- evaluates a State on the extent to which number of States’’ has been clarified in quality Assessments (Proposed it has a high-quality plan for supporting the Scoring Rubric (see Appendix B) so Selection Criterion (A)(2)): statewide transition to and that, on this aspect of the criterion, a Comment: A number of commenters implementation of enhanced standards supported the Department’s proposal to and high-quality assessments and State will earn ‘‘high’’ points if its evaluate a State’s commitment to provides examples of State or LEA consortium includes a majority of the improving the quality of its assessments support activities, including States in the country, and ‘‘medium’’ or by participating in a consortium of implementation of high-quality ‘‘low’’ points if its consortium includes States developing common high-quality instructional materials and assessments. one-half of the States in the country or assessments (as defined in this notice) In responding to this criterion, States less. Additionally, we added the aligned with the consortium’s common could propose to support development parenthetical ‘‘(as set forth in Appendix set of K–12 standards. However, other of local assessments, including B)’’ after ‘‘evidenced by’’ in criterion commenters requested that the formative and interim assessments, that (B)(2). Department remove this criterion, would assist in the transition to new In addition, we have made some non- stressing that the Department has statewide standards and assessments. substantive changes to this section for overemphasized standardized testing Criterion (C)(3) evaluates a State on the clarity. We have replaced ‘‘whether’’ and that the ESEA has stressed reading extent to which it has a high-quality with ‘‘to the extent to which’’ in and math to the detriment of other plan to increase the acquisition, criterion (B)(2); we have added ‘‘as subjects. One commenter asserted that a adoption, and use of local instructional evidenced by (i) the State’s participation State should not have to join a improvement systems (as defined in this * * *’’; and we have removed the consortium if its own assessment is of notice); supports LEAs and schools that phrase ‘‘that are internationally high quality. Another commenter are using instructional improvement benchmarked’’ when we refer to a questioned why we would encourage systems; and makes data from these common set of K–12 standards because States to change current assessment systems available and accessible to the phrase is unnecessary and programs; this commenter suggested researchers. Instructional improvement redundant with language in criterion that we not replace current assessments systems may include local assessment (B)(1)(i)(a). until there is certainty about which data. Comment: Many commenters aspects of current testing need change Changes: None. suggested that the Department consider so as to not waste resources and risk Comment: Several commenters additional factors in examining a State’s development of low-quality opposed the provision in criterion (B)(2) commitment to developing common assessments. Another commenter that asked a State to describe the extent assessments. One commenter suggested the Department support the to which its consortium working on recommended that States submit improvement of State and local developing common high-quality evidence from assessment developers assessment systems rather than assessments includes a ‘‘significant demonstrating that the assessments are pressuring States to ‘‘swap one number of States,’’ recommending valid and reliable for English language standardized test for another.’’ instead that the criterion focus only on learners, as well as showing the research Discussion: The Department believes the quality of the assessments. One base for use of accommodations. that consortia of States, by pooling commenter recommended that the Another commenter suggested that the resources, will be able to produce criterion evaluate the extent to which criterion explicitly encourage States to significantly higher-quality assessments the consortium has the potential to have develop a more comprehensive local more cost-effectively than any one State a significant national impact, including assessment system.
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Discussion: Members of an assessment Changes: We have added a program notice that new assessment systems consortium are responsible for ensuring requirement that no funds awarded should be aligned with content that assessments are developed to meet under this competition may be used to standards, and be vertically integrated. the definition of high-quality pay for costs related to statewide Another commenter suggested that the assessments (as defined in this notice), summative assessments. entire K–12 assessment system should including the requirement that Comment: A few commenters be vertically moderated to the anchor assessments are of high technical suggested that high-quality assessments assessments so ‘‘proficient’’ means quality and include students with include grade-by-grade specificity of ‘‘prepared’’ and that students are on- disabilities and English language core subject matter. Others suggested track to meet college and career ready learners. Local assessments can be this notice explicitly include the standards by graduation. addressed in response to other criteria, assessment of broad-based humanities Discussion: Under criterion (B)(2) such as criterion (B)(3) and (C)(3) as centered curricula, including art, States will be rewarded for the previously discussed. science, and social studies. development of assessments aligned Changes: None. Discussion: This notice does not limit with common standards that build Comment: A number of commenters or require certain grade or content toward college and career readiness. requested that the Department clarify in coverage for high-quality assessments. The technical aspects of how the the final notice how an applicant should Changes: None. assessment system is organized to Comment: Another commenter describe its strategy for and reflect increasing student competence suggested that we award additional commitment to joining a common from grade to grade will be determined points to States that commit to assessments consortium and by the consortia developing the developing a common STEM implementing common assessments. assessments. assessment. One commenter suggested that States Changes: None. Discussion: A State may choose to demonstrate compliance with this Comment: One commenter stated that address competitive preference priority criterion by developing a timeline for a plan for implementing high-quality 2, which addresses STEM issues, and, if when assessments would be aligned to assessments must include high-quality peer reviewers determine the State has the common standards. Two alternate assessments. met the priority, would receive extra Discussion: We agree with the commenters asked if States can include points in the Race to the Top commenter; however, we do not believe the cost of additional assessments, such competition. The third element of this it is necessary to include additional as formative and benchmark priority (a plan to address the need to language to that effect in this notice assessments, in addition to summative prepare more students for advanced because section 1111(b)(3)(C)(ix)(II) of tests in its application. Another study and careers in the sciences, the ESEA requires that States include commenter suggested that we evaluate technology, engineering, and students with disabilities in their States’ progress in relation to mathematics) could be addressed, in assessments. In addition, section developing common assessments on a part, by a commitment to develop a 612(a)(16)(C) of the IDEA requires States regular basis and that reports should be common STEM assessment. Note, to provide an alternate assessment to a provided on these evaluations. however, that a statewide summative student with a disability who needs it Discussion: It is not necessary for a STEM assessment would have to be for any statewide assessment. State to describe its strategy for joining developed using funds other than those Changes: None. a common assessments consortium; the awarded under this competition Comment: Several commenters evidence for this criterion focuses on a because, as noted in the previous supported the statement in the NPP that, State’s participation in a consortium comment, Race to the Top funds cannot at a later date, we may announce a that intends to develop high-quality be used to pay for costs related to separate Race to the Top Assessment assessments. The minimum evidence for statewide summative assessments. Competition, for approximately $350 which a State will receive points for this Changes: None. million, to support the development of criterion is described in detail in Comments: Some commenters asked assessments by consortia of States. Appendix A of this notice (Evidence that the Department provide incentives Several commenters asked for more and Performance Measures). The for States to develop and implement explicit guidelines on standards and Department intends to hold a separate high-quality assessments beginning at assessment work for Phases 1 and 2 as Race to the Top Assessment competition pre-kindergarten. described in this notice, as opposed to that will fund the development of Discussion: As previously stated, this the work for the separate $350 million common, summative assessments tied to notice does not limit or require certain fund for the development of common K–12 standards. We therefore grade or content coverage for high- assessments. believe that funds within this Race to quality assessments. We note, however, Discussion: As previously indicated, the Top competition would be better that invitational priority 3 invites States the Department intends to hold a spent on other activities. Accordingly, to include in their applications separate Race to the Top Assessment we have added a requirement specifying practices, strategies, or programs to competition that will fund consortia in that no funds awarded under this improve educational outcomes for high- developing common, summative competition may be used to pay for need young children by enhancing the assessments tied to common K–12 costs related to statewide summative quality of preschool programs. Of standards. The Department may provide assessments. Formative and interim particular interest are proposals that additional information about this assessments (as defined in this notice) support practices that (i) improve school competition in the future, and as noted may be funded within this competition, readiness (including social, emotional, previously, more requirements may be and would be funded as part of a State’s and cognitive); and (ii) improve the articulated in that competition’s notice. plan for criterion (B)(3). In addition, for transition between preschool and Changes: None. any State receiving funds, the kindergarten. Department will monitor the State’s Changes: None. Definition of High-Quality Assessment progress in meeting its goals and Comment: One commenter requested Comment: Many commenters timelines. that the Department state in the final supported the proposed definition of
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high-quality assessment. Several Therefore, we are revising the definition that the Department should expand the commenters recommended that the to clarify that a high-quality assessment activities that a transition plan might definition refer to the use of universal uses a variety of item types and formats include. For instance, several design principles in test development (e.g., open-ended responses, commenters suggested that States show and administration. A few commenters performance-based tasks) and that they plan to increase student suggested revising the definition to incorporates technology, where participation in Advanced Placement clarify that the use of open-ended items, appropriate. Second, for consistency and International Baccalaureate courses, performance-based tasks, and with the rest of the notice, we are as well as dual enrollment in technology are desirable and necessary changing the reference to ‘‘limited postsecondary credit-bearing courses, only insofar as they are grade- English proficient students’’ to ‘‘English while transitioning to common appropriate for the subject matter and language learners.’’ Next, the proposed standards and assessments. A few consistent with the skills to be definition stated that a high-quality commenters suggested States commit to measured. Many other commenters assessment be ‘‘of high technical quality increasing student participation in pre- recommended revising the definition to (e.g., valid, reliable, and aligned to Advanced Placement courses for middle include assessments and assessment standards).’’ For completeness, we are school students, and in after-school systems that measure higher order and adding ‘‘fair’’ to the examples in the programs to accelerate achievement for critical thinking, problem-solving, parenthetical. Finally, for clarity, we are students having difficulty meeting reasoning, research, writing, scientific changing ‘‘Such assessments are academic targets. One commenter investigation, communication, and structured to enable measurement of recommended that States provide a roll- teamwork skills. student achievement * * *’’ to ‘‘Such out plan for adoption of the common Discussion: We agree with the assessments should enable standards and all of their supporting commenters that the definition of high- measurement of student achievement.’’ components. Some commenters quality assessment should refer to the Changes: With the aforementioned suggested that adoption of common use of universal design principles in test changes, the definition of high-quality standards be accompanied by the design and administration and are assessment is as follows: ‘‘High-quality necessary supporting components, such making that change. However, we are assessment means an assessment as curricular frameworks, unit plans, not revising the definition to include designed to measure a student’s lesson plans, curriculum-embedded specific skills, such as critical thinking, knowledge, understanding of, and formative assessments, anchor problem solving, research, or writing ability to apply, critical concepts assignments, and rubrics. One skills, mentioned by the commenters through the use of a variety of item commenter noted that States should because the skills and content included types and formats (e.g., open-ended amend course requirements for in an assessment will be determined by responses, performance-based tasks). graduation to ensure that students are the content standards on which the Such assessments should enable guaranteed to receive the content. assessment is based. Instead, we are measurement of student achievement However, not all commenters revising the definition to state that a (as defined in this notice) and student supported additional supports and high-quality assessment is an growth (as defined in this notice); be of resources during a State’s transition to assessment that is designed to measure high technical quality (e.g., be valid, enhanced standards and high-quality a student’s ‘‘knowledge, understanding reliable, fair, and aligned to standards); assessments. One commenter of, and ability to apply, critical incorporate technology where questioned whether limited Race to the concepts,’’ rather than an assessment appropriate; include the assessment of Top funds should be used by States and that is designed to measure students with disabilities and English LEAs to develop instructional materials. ‘‘understanding of, and ability to apply, language learners; and to the extent Another commenter was critical of critical concepts.’’ feasible, use universal design principles requiring a plan for transition; instead We do not believe it is necessary to (as defined in section 3 of the Assistive this commenter suggested that a State clarify that open-ended items, Technology Act of 1998, as amended, 29 should be judged on its transition after performance-based tasks, and U.S.C. 3002) in development and implementation of common standards technology should be appropriate for administration.’’ and assessments, not before the State the grade and subject to be assessed and Comment: Several commenters has developed best practices. consistent with the skills to be recommended that the Department Discussion: We agree with many of measured, as recommended by require that high-quality assessments the commenters’ suggestions regarding commenters. We believe this is implicit address the needs of English language which supporting components should in the design of any assessment and learners, students with disabilities, and be considered when transitioning to have included open-ended responses, other learners who need targeted new standards and assessments. We performance-based tasks, and services. encourage States to create plans that technology as examples, not as Discussion: As defined in this notice, increase student participation in requirements of a high-quality a high-quality assessment includes advanced coursework in order to assessment. assessment of students with disabilities provide for a smooth transition to Finally, based on the Department’s and English language learners. internationally benchmarked standards internal review, we are making several Changes: None. aligned with college and career ready changes to the definition. First, in the Selection Criterion (B)(3): Supporting expectations. We also agree that a NPP, we stated that a high-quality the Transition to Enhanced Standards rollout plan and additional supports assessment uses a ‘‘variety of item types, and High-Quality Assessments would aid in the transition to enhanced formats, and administration conditions (Proposed Selection Criterion (A)(3)): standards and high-quality standards, (e.g., open-ended responses, Comment: Many commenters and have therefore incorporated these performance-based tasks, technology).’’ approved of criterion (B)(3) regarding a suggestions. We understand the We believe that a variety of State’s high-quality plan for supporting commenter’s concern that States may administration conditions is not a statewide transition to and need to amend course requirements for necessarily a requirement for an implementation of enhanced standards graduation to ensure that students are assessment to be of high quality. and high-quality assessments, but stated guaranteed to receive the content. We
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believe a statement in criterion (B)(3) improvements for science labs and group of stakeholders to better addresses this comment—that State or technology in the classrooms. implement its plans, as evidenced by LEA activities might include, ‘‘in Discussion: Consistent with the the strength of the statements or actions cooperation with the State’s institutions Department’s May 11, 2009, State Fiscal of support from the State’s teachers and of higher education, aligning high Stabilization Fund guidance ,3 the principals, which include the State’s school exit criteria and college entrance Department also discourages States and teachers’ unions or statewide teacher requirements with new standards and LEAs from using Race to the Top funds associations. assessments.’’ for new construction because this use We decline to take the commenter’s We disagree with commenters who may limit the ability of the State and its suggestion that a State focus its questioned whether limited Race to the LEAs to implement the State’s core Race professional development on middle Top funds should be used by States and to the Top plans. States may propose and high school teachers because we LEAs to develop instructional materials. that certain participating LEAs may use believe all teachers implementing We believe that the transition to Race to the Top funds for enhanced standards and high-quality enhanced assessments and a common modernization, renovation, or repair assessments would benefit from high- set of K–12 standards will not be projects to the extent that these projects quality professional development. successful without support from the are consistent with the State’s Race to Changes: We have included language States doing this work in collaboration the Top plan. in criterion (B)(3) to clarify that a State with their participating LEAs. Changes: None. or LEA activity might, for example, Comment: Several commenters We have made several edits for clarity include ‘‘developing or acquiring and observed that teachers will be primarily in the illustrative list of State and LEA delivering high-quality professional responsible for ensuring successful support activities for transition to development to support the transition to implementation of new standards and, enhanced standards and high-quality new standards and assessments.’’ accordingly, recommended that teachers assessments. We deleted the reference to be involved in a State’s transition plan. Comment: Numerous commenters developing curricular frameworks, for Commenters stated that a transition plan articulated a need for collaboration, example, but added a reference to should include model lesson plans, pre- stakeholder engagement, financial ‘‘high-quality instructional materials service teacher education, and in- support, autonomy, and flexibility and assessments (including, for service professional development to during the transition to enhanced example, formative and interim familiarize and train teachers on the standards and assessments. One assessments).’’ Additionally, we content standards and how to use commenter stated that unless States are accepted commenters’ suggestion to add assessment results. One commenter committed to the adoption and ‘‘development of a rollout plan for the suggested that professional development implementation of the standards, and standards with all supporting be focused on middle school and high support LEAs and schools in components,’’ which could include, school teachers. implementing them, the new standards among other things, development of Discussion: We agree with and assessments will not positively curricular frameworks and materials. commenters that a successful transition affect teaching or learning. One Changes: We have revised the plan should include high-quality commenter suggested that the State language in criterion (B)(3) to include professional development to support the plans require local school boards to many of the commenters’ suggestions. transition to new standards and ensure collaboration between school The language now reads that State or assessments. The NPP included administrators and union leaders to LEA activities might, for example, developing, disseminating and ensure that all educators are part of the include, ‘‘developing a rollout plan for implementing professional development alignment of assessments. A few the standards together with all of their materials as a suggested State or local commenters urged the Department to supporting components; in cooperation activity in this criterion. We are encourage continuity between pre- with the State’s institutions of higher strengthening the language about this kindergarten and elementary school as education, aligning high school exit activity to suggest development or part of the transition process. One criteria and college entrance acquisition and delivery of high-quality commenter supported efforts to promote requirements with the new standards professional development to support the a seamless articulation of standards and and assessments; developing or transition to new standards and assessments between pre-kindergarten, acquiring, disseminating, and assessments. We also agree with the K–12, and post-secondary education, implementing high-quality instructional commenter that teachers should be since any gap leads to critical loss of materials and assessments (including, involved in a State’s transition plan. learning for students. for example, formative and interim Under criterion (B)(3) the Department Discussion: The Department agrees assessments (both as defined in this will evaluate a State application on the with commenters that collaboration, notice)); developing or acquiring and extent to which it has a high-quality support, and engagement are critical delivering high-quality professional plan for supporting the transition to and factors for a successful transition to development to support the transition to implementation of enhanced standards enhanced standards and high-quality new standards and assessments; and and high-quality assessments, in assessments. The criteria in (A) engaging in other strategies that collaboration with its participating establish State Success Factors, which translate the standards and information LEAs. We expect that LEAs will ask States to articulate their education from assessments into classroom collaborate with teachers on this reform agendas and LEAs’ participation practice for all students, including high- criterion. In addition, in criterion in it, and explain their strategies for need students (as defined in this (A)(2)(ii)(a), a State is judged on the building strong statewide capacity to notice).’’ extent to which it has a high-quality implement, scale and sustain proposed Comment: One commenter suggested overall plan to (among other things) plans. Specifically, criterion (A)(2)(ii) including, as an additional activity to utilize the support it has from a broad provides for evaluation of a State’s plan support statewide transition to and to utilize the support it has from a broad implementation of enhanced standards 3 Available at: http://www.ed.gov/programs/ group of stakeholders to better and high-quality assessments, building statestabilization/guidance-mod-05112009.pdf. implement its plans, as evidenced by
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the strength of statements or actions of manner that is consistent with the mentioned by the commenter; we support from critical stakeholders. State’s application.’’ believe a State should have the Changes: None. Comment: One commenter flexibility to determine, in cooperation Comment: One commenter requested recommended that States should with its institutions of higher education, clarification about whether all LEAs or provide minimum protections for their the best way to align high school exit only participating LEAs must transition students during the transition to new criteria and college entrance to the enhanced standards and high- standards and assessments, including a requirements with the new standards quality assessments. Many commenters period of time to orient students and and assessments. However, we believe noted that the adoption of common teachers to new standards and that some clarification of the language standards will affect all LEAs, not only assessments, to ensure instruction time, in criterion (B)(3) is necessary and have those participating in a State’s Race to and to eliminate disparate impact on revised accordingly. the Top application. Accordingly, minority students. One commenter Changes: Criterion (B)(3) has been commenters suggested that a State requested that the Department address revised to provide that State or LEA include in its plan how it will provide equity in the adequacy of instructional activities might, for example, include, direct financial support for the materials, suggesting that States ensure ‘‘in cooperation with the State’s operational costs incurred by LEAs as that every student has access to print or institutions of higher education, they transition to common standards digital instructional materials that are aligning high school exit criteria and and assessments. current and aligned to the enhanced college entrance requirements with the Discussion: The NPP was clear that a standards. State will be judged on the extent to Discussion: We agree with new standards and assessments.’’ which it has a high-quality plan for commenters that a State should address Comment: A few commenters supporting a statewide transition to a supports for high-need students in its requested that States provide minimum common set of K–12 standards and plan to transition to enhanced standards evidence as to how they are ensuring high-quality assessments aligned to and high-quality assessments. We are proper implementation of their current those standards. We recognize that a adding a reference to high-need students standards, including evidence of actual statewide system of standards and in criterion (B)(3) and including a implementation in classrooms, such as assessments eventually would be definition of high-need students in the survey results from a representative implemented in all LEAs, some of Definitions section of this notice. States sample of teachers demonstrating how which are not participating in the Race should have the flexibility to decide on standards are being disseminated and to the Top grant. To address this the appropriate supports for their high- utilized. situation, we are adding a new need students; therefore, we decline to Discussion: For any State receiving definition of involved LEAs. An specify the supports States must provide funds, the Department will monitor the involved LEA is an LEA that chooses to to students. State’s progress in meeting its goals and work with the State to implement those Changes: We have added language to timelines as established in its plan. specific portions of the State’s plan that criterion (B)(3) indicating that State or Rather than requiring a State to use necessitate full or nearly-full statewide LEA activities might include ‘‘engaging survey results as minimum evidence for implementation, such as transitioning to in other strategies that translate the this criterion, as some commenters a common set of K–12 standards. standards and information from suggested, we will be gathering this Involved LEAs do not receive a share of assessments into classroom practice for kind of information through the 50 percent of a State’s grant award all students, including high-need evaluations. As stated elsewhere in this that it must subgrant to LEAs in students (as defined in this notice).’’ We notice, IES will be conducting a series accordance with section 14006(c) of the also have added a definition of high- of national evaluations of Race to the ARRA, but States may provide other need students, which reads as follows: Top State grantees as part of its funding to involved LEAs under the ‘‘High-need students means students at evaluation of programs funded under State’s Race to the Top grant in a risk of educational failure or otherwise the ARRA. Race to the Top grantee manner that is consistent with the in need of special assistance and States are not required to conduct State’s application. We expect that support, such as students who are living independent evaluations, but may participating LEAs will have a greater in poverty, who attend high-minority propose, within their applications, to role than involved LEAs in collaborating schools (as defined in this notice), who use funds from Race to the Top to with States as States develop their are far below grade level, who have left support independent evaluations. plans, but believe that the specifics of school before receiving a regular high Grantees must make available, through such decisions are best left to local school diploma, who are at risk of not formal or informal mechanisms, the decision makers. graduating with a diploma on time, who results of any evaluations they conduct Changes: We have added a new are homeless, who are in foster care, of their funded activities. In addition, as definition of involved LEAs, which who have been incarcerated, who have described elsewhere in this notice and reads as follows: ‘‘Involved LEAs mean disabilities, or who are English language regardless of the final components of the LEAs that choose to work with the State learners.’’ to implement those specific portions of Comment: One commenter suggested national evaluation, Race to the Top the State’s plan that necessitate full or that a State demonstrate that its public States, LEAs, and schools are required nearly-full statewide implementation, higher education institutions will certify to make work developed under this such as transitioning to a common set of readiness for entry into credit-bearing grant freely available to others, and K–12 standards (as defined in this coursework if students meet the high should identify and share promising notice). Involved LEAs do not receive a school common standards through practices and make data available to share of the 50 percent of a State’s grant completing a course of study aligned stakeholders and researchers (in award that it must subgrant to LEAs in with those standards and score at the appropriate ways that must comply with accordance with section 14006(c) of the defined college-ready level on high FERPA, including 34 CFR Part 99, as ARRA, but States may provide other school assessments. well as State and local requirements funding to involved LEAs under the Discussion: We do not believe that we regarding privacy). State’s Race to the Top grant in a should prescribe the exact policy Changes: None.
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C. Data Systems To Support Instruction funds, to build out a State’s data statewide longitudinal data systems be infrastructure. designed to allow for analysis of student Definitions: Instructional Improvement Changes: None. achievement by race, ethnicity, System Comment: One commenter indicated socioeconomic status, gender, disability, Comments regarding the preceding that a State should plan for the and English language learner status. One definition are addressed, as appropriate, operational costs of implementing data commenter recommended that the below. systems that a Race to the Top grant Department encourage States to Selection Criterion (C)(1): Fully does not cover. This commenter disaggregate data of vulnerable Implementing a Statewide Longitudinal recommended that the Department populations such as pregnant and Data System (Proposed Selection require each State to specifically parenting students. One commenter Criterion (B)(1)): indicate in its application how it plans noted that it is critical that the statewide Comment: Many commenters to technically and financially support longitudinal data system measure all supported criterion (C)(1) that provides LEAs across the State, including proficiency levels (i.e., below for a State to be evaluated based on the developing contracts and systems that proficiency, at proficiency, above extent to which it has a statewide can reduce costs by involving multiple proficiency, and advanced) instead of longitudinal data system that includes LEAs. just measuring below or above Discussion: We agree with all of the America COMPETES Act proficiency. commenters that it is important for a elements. Other commenters suggested Other commenters recommended State to consider funding issues in its that the Department consider using Race non-assessment related data elements to data system implementation plans, as to the Top funds for purposes other than be included in statewide longitudinal well as its overall plans. Under criterion data systems, such as providing direct data systems, such as college readiness (A)(2)(i)(e), a State will be evaluated on indicators, graduation rates, attendance services in schools with demonstrated the extent to which it has a high-quality needs or improving the infrastructure rates, student enrollment data, course overall plan to ensure that it has the enrollment, student mobility rates, for the delivery of instruction. One capacity required to implement its commenter suggested using the funds to budget information, completion rates, proposed plans by using the fiscal, curriculum changes, and instructional develop new standards and assessments political, and human capital resources time. A few commenters suggested that first, rather than building a longitudinal of the State to continue, after the period in order to evaluate the progress of data system based on current standards of funding has ended, those reforms individual students through the K–12 and assessment systems. One funded under the grant for which there system and into postsecondary commenter suggested that rather than is evidence of success. education, systems should include having a major focus on State collection Changes: None. information such as the percentage of and sharing of data, the Department Comment: Many commenters students from each high school should require States to help schools applauded criterion (C)(1), which enrolling in institutions of higher and LEAs develop longitudinal data evaluates the extent to which a State has education, students taking remedial or collection systems. a statewide longitudinal data system developmental coursework in college, or Discussion: The Department that includes all of the elements the points at which students exit, appreciates the support for the specified in section 6401(e)(2)(D) of the transfer in, transfer out, drop out, or development and implementation of America COMPETES Act. Several complete P–16 education programs. One statewide longitudinal data systems. We commenters specifically highlighted the commenter suggested that the data disagree with commenters who importance of including unique systems include model lesson plans for recommend that funds not be used for identifiers for students, teachers, and teachers. this purpose. Data is an important tool administrators in the list of America Some commenters recommended to identify needs and improve COMPETES Act data elements. including data related to indicators of instruction. In addition, section However, many commenters suggested school safety, culture and climate. 14006(a)(2) of the ARRA directs the additional data elements that should be Others suggested including information Secretary to make grants to States that collected and reported through these about student, family and community have made significant progress in systems. engagement. A few commenters meeting the objectives of paragraphs (2), Commenters indicated that these data requested that the data systems include (3), (4), and (5) of section 14005(d), systems should include multiple student social service-related data including the development of statewide achievement measures and multiple elements and health indicators, such as longitudinal data systems that include data sources, such as annual immunization rates, asthma rates, vision the elements described in section achievement data for all core academic and hearing screening, and obesity rates. 6401(e)(2)(D) of the America subjects, as defined in the ESEA, valid Several commenters recommended COMPETES Act. While criterion (C)(1) and reliable local and State assessment including measures of students’ social is a measure of the current status of results, formative assessment results, and emotional health and character States’ implementation of their performance assessment results, and development. Others believed that data statewide longitudinal data systems English language proficiency results. systems should provide data regarding under the America COMPETES Act (as One commenter recommended that the the numbers of transfers, dropout rates, defined in this notice), both criteria data systems include data that chronic absenteeism, suspension rates, (C)(2) and (C)(3) provide for the demonstrate a student’s ability to apply, truancy, and dropout re-enrollment in evaluation of States’ plans to enhance analyze, synthesize and evaluate order to trigger supports and their statewide longitudinal data content knowledge. A few commenters interventions for students and families. systems and local instructional recommended collecting data on the Commenters also suggested that improvement systems. Funds awarded rates of students reading at grade-level statewide longitudinal data systems under the Department’s statewide by grade 3. should include data about teaching and longitudinal data systems grants Some commenters recommended learning conditions, such as teacher program may also be used, in various ways data should be recruitment and retention, educator coordination with Race to the Top disaggregated. They suggested that turnover, pupil and teacher ratios,
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subject area teacher certification, full- English language learner programs, early applications in which the State plans to time equivalent teacher employment, childhood programs, at-risk and drop- create practices, strategies, or programs and the commitment to current out prevention programs, and school to improve educational outcomes for educational programs (i.e., whether the climate and culture programs, as well as high-need young children by enhancing curriculum has changed) in order to information on student mobility, human the quality of preschool programs; (b) help schools, districts and States better resources (i.e. information on teachers, invitational priority 4, which invites understand supports and barriers to principals, and other staff), finance, applications that propose to expand teacher effectiveness. student health, postsecondary, and statewide longitudinal data systems to One commenter recommended that other relevant areas, with the purpose of include or integrate data from early statewide longitudinal data systems connecting and coordinating all parts of childhood programs, among other include information about English the system to allow important questions programs; and (c) invitational priority 5, language learners, such as the type of related to policy, practice, or overall inviting applications in which the State English language learner instructional effectiveness to be asked and answered, plans to address how early childhood program in which a student participates, and incorporated into effective programs, K–12 schools, postsecondary time in that program, level of English continuous improvement practices. institutions, workforce development proficiency, and date of reclassification. While the Secretary is interested in organizations, and other State agencies Some commenters suggested requiring applications that meet this invitational and community partners, will data about student participation in other priority, a State meeting the priority coordinate to improve all parts of the programs, such as data on students would not receive additional points or education system and create a more served in gifted and talented education preference over other applications. A seamless pre-kindergarten-20 route for programs, innovative programs, State will be evaluated based on the students. While the Secretary is expanded learning programs, or extent to which it has a statewide interested in applications that meet students receiving advanced longitudinal data system that includes these invitational priorities, we decline coursework. One commenter all of the elements specified in section to require that statewide longitudinal recommended that data on technology 6401(e)(2)(D) of the America data systems include additional use be explicitly included in statewide COMPETES Act. information about early childhood longitudinal data systems. Changes: None. programs because that would go beyond Some commenters recommended that Early Childhood the data elements specified in the statewide longitudinal data systems America COMPETES Act. include linkages with students in adult Comment: Several commenters Changes: None. basic education, workforce and skills supported the fact that a statewide training programs and corrections longitudinal data system, as specified by Timeline systems, and student information from the America COMPETES Act, would Comment: Many commenters State employment wage records. include student information beginning suggested that a State be evaluated One commenter stated that we did not at the pre-kindergarten level. Some based on the degree of progress it has provide sufficient justification for why commenters recommended that the made on developing a system that all these data elements are essential. Department require a State to expand its would comply with the America Another commenter suggested that the longitudinal data system by linking with COMPETES Act rather than on the Department give States latitude to available data on young children; their extent to which a State has completed define the elements included in their participation in early childhood these efforts. Another commenter data systems. education programs; and the suggested a State be judged on a plan to Discussion: Some of the data elements characteristics, quality, staffing, and implement any missing elements of its suggested by commenters mirror the funding of those programs in order to statewide longitudinal data system. data elements listed in the America increase access, improve quality, Several commenters also stated that it is COMPETES Act. Although the identify critical social services and not feasible for some States to have a Department will not be evaluating interventions, and align standards, completed statewide longitudinal data whether a State’s system has curricula and assessments from pre- system to be in place by September 30, information beyond the 12 elements of kindergarten through grade 3. A few 2011, the date specified in the notice of the America COMPETES Act, we commenters recommended that a data proposed requirements for the State recognize the varying needs and system be designed so that data Fiscal Stabilization Fund. capabilities of States, and we encourage eventually can be captured at birth and Discussion: The State Reform States to track additional information fed into a Quality Rating Improvement Conditions Criteria are used to assess a through their longitudinal data systems System, if a State has such a system. State’s past progress and its success in or to add additional components to their Discussion: We agree with creating conditions for reform in special State plans to the extent the State deems commenters that data about early areas related to the four ARRA appropriate. However, the Department childhood education programs are education reform areas. A State will be recognizes the financial burden of important to help ensure that young judged on the extent to which it has, collecting data, and we believe that it is children begin school ready to learn. already in place, a statewide sufficient to specifically evaluate States The America COMPETES Act elements longitudinal data system that includes only on the extent to which their specify a pre-kindergarten-16 data the elements in the America statewide longitudinal data systems system. If it chooses, a State may link its COMPETES Act. Some commenters include the elements in the America longitudinal data system to available misunderstood criterion (C)(1); this COMPETES Act. data on young children and their notice does not require the statewide As stated in invitational priority 4, the participation in early childhood longitudinal data system to be Secretary is particularly interested in programs, consistent with FERPA, completed by a particular date. Rather, applications in which the State plans to including 34 CFR Part 99. This notice a State will receive points for the expand statewide longitudinal data has several invitational priorities elements it has completed at the time it systems to include or integrate data regarding early childhood programs: (a) submits its application. from special education programs, Invitational priority 3, inviting Changes: None.
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Development of a Statewide systems for determining student that receive Race to the Top grant Longitudinal Data System progress. awards will need to comply with Discussion: We agree with FERPA, including 34 CFR Part 99, as Comment: Several commenters commenters who emphasize the well as State and local requirements stressed the importance of stakeholder importance of data and assessment regarding privacy. support and technical expertise in the systems that support the measurement Changes: None. development and implementation of of student growth. In this notice, Selection Criterion (C)(2) (proposed statewide longitudinal data systems. student growth is defined as the change Selection Criterion (B)(2)): Accessing Some commenters suggested that we in achievement data for an individual and using State data: provide incentives to encourage States student between two or more points in Uses of Data to design data systems using input from time. A State may also include other professional standards boards. Other measures that are rigorous and Comment: Several commenters commenters recommended seeking comparable across classrooms. Given expressed support for our proposal to feedback from parents, businesses, this definition, we decline to specify or evaluate State Race to the Top educators, community-based partners, restrict the structure of statewide applications based on the extent to universities, hospitals, and students on longitudinal data or assessment systems which the State plans to use this data to the content and overall effectiveness of but rather allow States the flexibility to inform and engage key stakeholders, the statewide longitudinal data system. develop data and assessment systems, as such as policymakers, parents, students, Discussion: We agree with long as they support a growth measure and the public, so that they have commenters that stakeholder and expert that is rigorous and comparable across information about how well students are support in developing a longitudinal classrooms. performing. Many commenters data system is important. However, we Changes: None. recommended that these data systems believe that each State is in the best Comment: Many commenters stressed should also be used to identify position to determine how best to solicit that it was important for States to continuous improvement goals, address technical expertise and stakeholder develop interoperable data systems that barriers that compromise student support and from which groups. are aligned with existing technology success, and highlight understanding of Accordingly, we do not believe it is platforms and able to incorporate data best practices. Some commenters necessary to specify the input and from existing data management systems. suggested these data systems be used to support each State should seek. Commenters also stressed the improve instructional practice by Changes: None. importance of ensuring that statewide facilitating the use of differentiated instruction, to make individualized Comment: Some commenters longitudinal data systems can decisions about students’ academic and suggested particular qualities of strong ‘‘communicate’’ with each other so that developmental needs, and to design statewide longitudinal data systems. the data in these systems can be used by comprehensive interventions to address They argued that data sets must be early childhood centers and institutions those needs. A few commenters common across districts, cross- of higher education, within and among suggested that States use these data operational, and supportive of schools, within and among LEAs, systems to inform professional developing a robust, accurate, and among State and local agencies, across States and with Federal agencies. One development and teacher and immediately useful data mine. commenter requested that the administrator evaluations, evaluate Commenters emphasized the Department provide additional teacher preparation programs, allow for importance of developing data systems clarification regarding America the monitoring of teacher and principal that are comprehensive, systemic, COMPETES Act element (4), ‘‘the assignments, and ensure equitable reliable, valid, and designed for long- capacity to communicate with higher distribution of teachers. One commenter term use. One commenter suggested that education data systems’’ and whether suggested that data be used to address the Department ensure data elements this capacity includes data integration conditions that lead to the racial are used to create uniform cohorts. or two-way communication. isolation of low income students. Discussion: We agree with Discussion: The COMPETES Act Commenters recommended that data commenters that these are important requires a statewide longitudinal data systems be used to inform strategic characteristics of a statewide system to have the capacity to planning, inform resource allocation longitudinal data system. We believe communicate with higher education decisions, and support decision-makers that the 12 data elements in the America data systems. Therefore, statewide in overall organizational effectiveness. COMPETES Act represent the qualities longitudinal data systems should have In order to ensure that all students have suggested by the commenters, and the ability to link an individual student equitable access to education, one therefore, no change is necessary. record from one system to another, commenter recommended that data be Changes: None. consistent with FERPA, including 34 analyzed to identify and implement an Comment: One commenter CFR Part 99. Additionally, these appropriate array of options that use recommended that the State data systems should meet interoperability early access to college coursework as a systems should reflect sufficient grade- and portability standards, which will way to promote college readiness for to-grade alignment in order to ensure ensure that they have timely and every student. that valid grade-level growth reliable opportunities to share data Discussion: Criterion (C)(2) will be determinations can be made in each across different sectors within a State used to evaluate a State on the extent to State. This commenter urged that the and across States. Timely and reliable which it has a high-quality plan to Department require that such growth information from across sectors will ensure that the data from its statewide measures be used only with vertically facilitate the evaluation of which longitudinal data system are accessible scaled assessments that are appropriate program or combinations of programs is to, and used to inform and engage for examining value-added growth. Two improving outcomes for students. Note decision-makers in the continuous commenters recommended emphasizing that States must consider how to protect improvement of policy, instruction, the importance of States using cohort student privacy as data are shared operations, management, resource data in the statewide longitudinal data across agencies. Successful applicants allocation, and overall effectiveness. We
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agree with the commenters that data data downloads) and timelines in which parents), youth-serving community- from these systems can be used for it plans to provide the appropriate level based organizations and value-added many of the purposes indentified by the of data to the different stakeholders, as intermediaries, parent teacher commenters. However, we believe most well as its communication plans to associations, nonprofit organizations, of these are covered in the broad ensure that stakeholders are aware this workforce investment boards, business categories of instruction, operations information is available. Some leaders, community groups, institutions management, and resource allocation. commenters were especially concerned of higher education involved in the We are revising the criterion to specify that the data are accessible to preparation of new teachers, and early that such data can also be used in the communities and families, and in childhood program providers. areas of ‘‘policy’’ and ‘‘overall particular, that these stakeholders be Discussion: The list of stakeholders in effectiveness.’’ provided support in understanding data criterion (C)(2) is meant to be Changes: We have revised criterion and their uses to monitor children’s illustrative, but not exhaustive. States (C)(2) to include ‘‘policy,’’ and ‘‘overall progress and to hold districts and should make data available, consistent effectiveness’’ as areas for which data schools accountable. with FERPA, including 34 CFR Part 99, may be used. A few commenters recommended that to any relevant stakeholder it deems States and LEAs provide parents and the appropriate. We do not, however, think Building Capacity public with clear and concise annual it is necessary to add more examples of Comment: Several commenters stated reports that are useful and relevant to all stakeholders to this criterion. that the Race to the Top funds should constituencies. Commenters suggested Changes: None. be used to build State capacity for data topics that should be included in these Comment: Many commenters accuracy, analysis, and dissemination. reports, such as an overall assessment of recommended that the Department One commenter urged the Department education, reports on school quality, require a State to address how public to consider ways to help States expand descriptions of progress in the core charter schools will have the same and use longitudinal data systems. academic subjects, and indicators of the access to the information produced by Other commenters recommended that a health and safety of children. One these data systems as traditional public State be judged on its capacity to use the commenter suggested that States schools. Commenters believed that data contained in these systems or how include in reports an opportunity-to- access to high-quality student-level data it has moved from collecting data to learn index to track data about the is critical to the successful operation of transforming the data into actionable quality of State and local education all public schools, including public information for use. systems. Another commenter suggested charter schools, and is a key Discussion: We agree with the that reports provide teachers with data underpinning of any accountability commenter that State plans under this on the growth of their students on based system. Another commenter criterion should include a proposal for interim or summative assessments. A requested that the Department clarify how the State will improve its own few commenters noted the importance that charter schools must provide data capacity to analyze and use data. We of consultation with stakeholders after to States. believe the criterion makes this clear the data are reported, recommending Discussion: The Department agrees and that no further changes are needed. that States and LEAs address in their that charter schools should have the In addition, invitational priority 4 application how they plan to same access to the information indicates that the Secretary is disseminate and explain the data to produced by statewide longitudinal data particularly interested in applications in stakeholders and how they will use systems as traditional public schools which States propose working together community input to develop a plan of and States should ensure this access. to adapt one State’s statewide action to improve schools. Nothing in this notice would prohibit longitudinal data system so that it may Discussion: We agree with equal access to data for public charter be used, in whole or in part, by other commenters that data should be schools. Public charter schools must States, rather than having each State accessible to key stakeholders and that provide States with any data specified build or continue building such systems reports including those data should by the State on the same basis as other independently. We will consider the provide useful information to them. A public schools. commenter’s request for the Department State’s application will be evaluated on Changes: None. to help States expand their statewide the extent to which it has a high-quality Privacy Issues longitudinal data systems as we develop plan to make sure its data are accessible plans to provide technical assistance to to, and used to inform and engage key Comments: Several commenters grantees. stakeholders. However, we decline to recommended that the Department Changes: None. specify the exact format of the data, require a State to provide assurances what might be included in reports, the concerning the safeguards it has in place Accessibility of Data specific input or consultation with to protect the privacy of students and Comment: Some commenters stakeholders, or the timelines for school employees as data about them recommended adding language to sharing data given the unique nature of are shared. criterion (C)(2) to ensure that data from statewide longitudinal data systems and Discussion: States must consider how a State’s statewide longitudinal data the differing needs of constituencies to protect student privacy as data are system are accessible to key within States. These are all potential shared. Successful applicants that stakeholders. For instance, commenters elements that States could include, receive Race to the Top grant awards suggested requiring a State to describe however, in their Race to the Top plans. will need to comply with FERPA, and how its data are presented in a format Changes: None. its implementing regulations 34 CFR and language that key stakeholders can Comment: Some commenters Part 99, as well as any applicable State access and understand, and are in a suggested adding to the list of and local requirements. Because a format that is easy to interpret and stakeholders in criterion (C)(2) other State’s compliance with FERPA is a analyze. One commenter suggested that groups who should have access to data requirement with which all recipients of this notice compel a State to describe from statewide longitudinal data Department funds must meet, we are the format (e.g., dashboards, reports, systems, such as families (instead of removing the reference to compliance
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with FERPA from the text of the FERPA. The Department is not aware of identifiable information from K–12 selection criteria in (C). To remind any other Federal laws that would education records to a postsecondary States of their obligations under FERPA, prohibit or pose barriers to a State institution is permitted under the we are including a footnote with a establishing a statewide longitudinal enrollment exception, provided the reference to the statute and data system. To the extent that State notification and access conditions are implementing regulations in this laws present barriers to the met. Postsecondary institutions may section. development of a statewide longitudinal disclose personally identifiable The Department agrees that teacher data system in compliance with the information to an SEA under the and principal privacy also must be ARRA, the State will likely need to take evaluation exception if the SEA has the protected. However, teacher and specific actions to address those authority to conduct an audit or principal privacy is governed by State barriers. The Department will provide evaluation of the postsecondary law. States, LEAs, and schools should further clarification in this area as institution’s education programs. (20 consider their individual State privacy warranted. U.S.C. 1232g(b)(1)(C), (b)(3), and (b)(5); statutes when addressing these privacy Changes: None. 34 CFR 99.31(a)(3) and 99.35). States issues in the establishment of a Comments: Some commenters asked that have not established the requisite statewide longitudinal data system. the Department to clearly explain how authority may do so in a number of Changes: We moved the references to post-secondary institutions, K–12, and ways, such as: (1) Creating an entity in FERPA from the criteria in (C) to a pre-kindergarten-K education systems the State to house the statewide footnote in that same section. can share restricted student information. longitudinal data system and endowing Comments: Several commenters Discussion: As stated previously, the that entity with the authority to conduct stated that the Department should establishment of a statewide evaluations of elementary, secondary, harmonize Federal policy to ensure that longitudinal data system with the and postsecondary education programs; individual privacy protections are necessary functionality to incorporate or (2) granting authority at the SEA or safeguarded in a way that does not all 12 of the COMPETES Act elements, IHE level to conduct evaluations of interfere with timely and necessary including the sharing of data between elementary, secondary and information sharing. Some commenters pre-kindergarten-12 and postsecondary postsecondary education programs. expressed concern that States may face data systems, by itself, does not violate States may grant authority through challenges in fully implementing FERPA. States also may implement a various vehicles, including for example, statewide longitudinal data systems statewide longitudinal data system that Executive Orders, regulations and while meeting the requirements of includes the disclosure and redisclosure legislation. In some States the formation FERPA unless current FERPA of personally identifiable information documents for SEAs, IHEs or other regulations regarding data-sharing from education records in a manner that educational entities may already grant among State agencies are revised. They complies with FERPA. In addition to the necessary authority; however, recommended that the FERPA complying with FERPA, any sharing of explicit statutory authority is not regulations be revised to explicitly student data must also comply with the required by FERPA. allow for interagency data exchanges so requirements of 34 CFR 104.42(b)(4) (the The Department recognizes that there the Administration’s policy goals for regulations implementing section 504 of is considerable variation among States’ Race to the Top can be realized. the Rehabilitation Act), generally governance structures and laws, and Discussion: The Department prohibiting postsecondary institutions that using this exception to obtain recognizes that further clarity on FERPA from making pre-admission inquiries personally identifiable information from and the America COMPETES Act will about an applicant’s disability status. postsecondary institutions may be facilitate States’ ability to develop and We first address the question of the difficult. The Department is currently implement statewide longitudinal data disclosure and redisclosure of reviewing its regulations and policies in systems that contain all 12 data personally identifiable information in this area and will be in close elements outlined in the America the pre-kindergarten context. The communications with States over the COMPETES Act. The establishment of a disclosure of personally identifiable next several months regarding these statewide longitudinal data system with information from pre-kindergarten to issues. Of course, the Department also is the necessary functionality to LEAs is not affected by FERPA with available, upon request, to provide incorporate all 12 of the COMPETES Act respect to pre-kindergarten programs States with technical assistance on how elements, by itself, does not violate that do not receive funding from the to implement a statewide longitudinal FERPA. The actual implementation of Department, as FERPA does not apply to data system that meets the requirements such a system (including the disclosure those programs. With respect to pre- of FERPA. and redisclosure of personally kindergarten programs that receive Changes: None. identifiable information from education funding from the Department, the non- Comment: A few commenters records) also does not violate FERPA consensual disclosure of personally requested that the Department provide provided that States follow FERPA’s identifiable information from the specific guidance about the de- specific requirements. For example, the students’ pre-kindergarten education identification process that all States Department’s current interpretation of records to LEAs is permitted under the must adhere to in order to share FERPA is not a barrier to importing data enrollment exception in the FERPA potentially identifiable information into an educational agency from another regulations, provided that certain about students. State agency, since FERPA only applies notification and access requirements are Discussion: It is not possible to to the personally identifiable met. (20 U.S.C. 1232g(b)(1)(B); 34 CFR prescribe or identify a single method to information contained in education 99.31(a)(2) and 99.34). minimize the risk of disclosing records. In the following discussions, in The second issue raised by personally identifiable information in response to specific questions from commenters involved the sharing of redacted records or statistical commenters, we provide greater detail information between postsecondary information that will apply in every about how a statewide longitudinal data institutions and SEAs. Similar to the circumstance, including determining system may be established and pre-kindergarten context, the non- whether defining a minimum cell size is implemented in compliance with consensual disclosure of personally an appropriate means to protect the
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confidentiality of aggregated data and, if plan the State and LEA roles and participating LEAs accountable for so, selection of an appropriate number. responsibilities related to using data to progress and performance, and This is because determining whether a improve instruction, including how the intervening where necessary. In particular set of methods for de- plan would ensure that LEAs are addition, under criterion (C)(3)(i), a identifying data and limiting disclosure primarily responsible for creating State will be evaluated on the extent to risk is adequate cannot be made without instructional improvement systems with which it, in collaboration with its examining the underlying data sets, assistance and support from the State. participating LEAs, has a high-quality other data that have been released, One commenter recommended that the plan to increase the LEAs’ acquisition, publicly available directories, and other Department increase the explicit adoption, and use of local instructional data that are linked or can be linked to emphasis on adoption and improvement systems that provide the information in question. For these implementation of local data and teachers, principals, and administrators reasons, we are unable to provide instructional improvement systems. with the information and resources they examples of rules and policies that Discussion: Application requirement need to improve their instructional necessarily meet the de-identification (e)(4) requires States to describe, for practices, decision-making, and overall requirements in 34 CFR 99.31(b). The each Reform Plan Criteria that it chooses effectiveness. This could include releasing party is responsible for to address, the parties responsible for facilitating collaboration between LEAs. conducting its own analysis and implementing the activities. We Given these existing criteria, we do not identifying the best methods to protect therefore do not feel it is necessary to believe a change is necessary. the confidentiality of information from specify in the criterion itself that a State Changes: None. education records it chooses to release. should describe its roles and Comment: One commenter suggested We recommend that State educational responsibilities and that of its LEAs. that the Department allow States to authorities, educational agencies and However, we agree with the commenters focus on early childhood care and institutions, and other parties refer to that criterion (C)(3)(i) concerns local development data systems exclusively, the examples and methods described in instructional improvement systems, and without penalty for not including K–12 the notice of proposed rulemaking to we are revising it to clarify this. We are instructional improvement systems. amend its FERPA regulations that the also clarifying that the plans under this Discussion: While we believe it is Department published in the Federal criterion should include efforts to important for instructional Register on March 24, 2008 (73 FR increase the acquisition and adoption of improvement systems to include tools 15574, 15584) (FERPA notice of such systems. for improving early childhood care, we proposed rulemaking) and refer to the Changes: Criterion (C)(3)(i) now decline to make the commenter’s Federal Committee on Statistical begins, ‘‘Increase the acquisition, suggested change. Section 14005(c) of Methodology’s Statistical Policy adoption, and use of local instructional the ARRA requires a State, when Working Paper 22, http://www.fcsm.gov/ improvement systems.’’ applying for a Race to the Top grant, to working-papers/spwp22.html, for Comment: Some commenters describe the status of the State’s additional guidance. suggested that a State be evaluated on progress in each of the four assurance Further, as noted in the preceding the degree to which it can demonstrate areas in section 14005(d), including paragraph and in the preamble to the collaboration and cooperation with and improving the collection and use of FERPA NPRM, use of minimum cell among LEAs. Several commenters data. We believe the assurance in the sizes or data suppression is only one of recommended that the Department ARRA related to the use of data is several ways in which information from include an incentive for States and intended to cover all levels of the education records may be de-identified LEAs to learn from outstanding LEAs in educational system. before release. Statistical Policy data development and reporting in order Changes: None. Working Paper 22 describes other to improve vertical alignment of the Comment: Several commenters disclosure limitation methods, such as State’s education system. recommended revising criterion (C)(3)(i) ‘‘top coding’’ and ‘‘data swapping,’’ Discussion: As described elsewhere in to include other stakeholders, in which may be more suitable than simple this notice, States receiving Race to the addition to teachers and principals, who data suppression for releasing the Top funds, along with their LEAs and can benefit from using data to improve maximum amount of information to the schools, are expected to identify and instruction, such as youth development public without breaching confidentiality share promising practices, make work professionals in after-school and requirements. Decisions regarding freely available to others and make data summer programs, mentoring and after- whether to use data suppression or available in appropriate ways that school learning organizations, expanded some other method or combination of comply with FERPA to stakeholders and learning time partners, early childhood methods to avoid disclosing personally researchers. Specifically, criterion providers, and program directors. identifiable information in statistical (A)(1)(ii) provides for the evaluation of Discussion: We understand that there information must be made on a case-by- a State based on the extent to which the are other stakeholders outside of the case basis. participating LEAs are strongly school who play critical roles in With regard to issues with ESEA committed to the State’s plans and to education. Criterion (C)(2) addresses reporting in particular, determining the effective implementation of reform in how data from a statewide longitudinal minimum cell size to ensure statistical the four education areas. Criterion data system can be used by a wide range reliability of information is a completely (A)(2)(i)(b) asks the State to demonstrate of stakeholders, whereas criterion different analysis than that used to how it will support participating LEAs (C)(3)(i) is focused on how data are determine the appropriate minimum in successfully implementing the specifically used in instructional cell size to ensure confidentiality. education reform plans the State has improvement systems to improve Changes: None. proposed, through such activities as instructional practices, decision- Selection Criterion (C)(3): Using data identifying promising practices, making, and overall effectiveness during to improve instruction (proposed evaluating these practices’ effectiveness, the school day. We believe the list of Selection Criterion (B)(3)): ceasing ineffective practices, widely stakeholders in criterion (C)(3)(i) is Comment: One commenter disseminating and replicating the appropriate given this focus, therefore, recommended that a State describe in its effective practices statewide, holding we do not believe it is necessary to
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revise this criterion. However, nothing they need. In addition, criterion (D)(5) to evaluation contractors and State and in this notice would prevent a State addresses the need for high-quality Federal officials. from specifying in its plan additional professional development. The Changes: None. stakeholders who may use instructional Department also encourages States to Comment: Many commenters improvement systems. utilize current Federal education suggested that the Department clarify Changes: None. funding, for example Title II–A that instructional improvement systems Comment: Some commenters stated Improving Teacher Quality State grants, should identify students who are off- that, in addition to making data as a funding mechanism to provide track to graduation or have dropped out available, there must also be an equal further professional development to of school. These commenters said that focus on building the capacity of teachers in the use of data in the early warning indicators can be used by educators and school leaders to analyze classroom. LEAs and States to develop and and use this information. They argued We do not believe we should require implement options that will keep that a State should describe how it will a State to articulate the means by which students on track, or put them back on support its LEAs in providing effective, it will require educators seeking track, to graduation. collaboratively designed and research- certification or re-certification to receive Discussion: We agree with the based professional development, training and show competence in the commenter that instructional including pre-service training to analysis, interpretation, and use of data. improvement systems should provide teachers, principals and administrators A State may address this issue in its early warning indicators about students on how to analyze and use these data. plan if it chooses. at risk of educational failure and are revising the definition of instructional One commenter suggested that Changes: Criterion (C)(3)(ii) has been improvement systems accordingly. We professional development opportunities added to provide that a State will be also are revising criterion (C)(3)(iii) to be include a focus on using multiple evaluated based on the extent to which sources of information to assess student consistent with criterion (C)(3)(ii) and to it has a high-quality plan to support academic performance; using a variety clarify that the data from instructional LEAs and schools that are using of strategies to analyze data; using data improvement systems, together with instructional improvement systems (as to identify barriers for success, design statewide longitudinal data system data, defined in this notice) in providing strategies for improvement, and plan should be made available and accessible effective professional development to daily instruction; benchmarking to researchers. teachers, principals, and administrators successful schools with similar Changes: We have revised the on how to use these systems and the demographics to identify strategies for definition of instructional improvement resulting data to support continuous improvement; and, creating a school systems to clarify that such systems may instructional improvement. As a result environment that makes data-driven also integrate instructional data with decisions. of this addition, proposed criterion other student-level data such as One commenter suggested that a State (C)(3)(ii) has been redesignated attendance, discipline, grades, credit should articulate the means by which it (C)(3)(iii). We have also revised criterion accumulation, and student survey will require educators seeking (C)(3)(i) to clarify that instructional results to provide early warning certification or re-certification to receive improvement systems should provide indicators of a student’s risk of training and show competence in the educators with the ‘‘information and educational failure. We have also analysis, interpretation, and use of data. resources they need to inform and revised criterion (C)(3)(iii) to clarify that Several commenters suggested that time improve their instructional practices, the data from ‘‘instructional during the school day should be decision-making, and overall improvement systems,’’ together with dedicated to data analysis and action effectiveness.’’ statewide longitudinal data system data, planning for teachers. Another Comment: One commenter did not should be made available and accessible commenter suggested that a State be support making data available and to researchers. required to explain how it will promote accessible to researchers. This Comment: One commenter an environment (e.g., a climate of commenter stated that large urban recommended that the Department autonomy) in which teachers, districts are deluged with requests for clarify the definition of instructional principals, and administrators have the information and access to data, which improvement systems to reference use of support and conditions to make diverts time and resources from student- technology-based tools and other decisions based on the results of the centered activities, and that this strategies to systemically manage cycles data analyses. misconstrues the purpose of Race to the of continuous instructional Discussion: We agree with Top to improve student achievement improvement. A few commenters commenters that States must support and close achievement gaps. Rather than suggested that instructional their LEAs in providing effective making data available to researchers for improvement systems should be professional development. We are the purposes specified in criterion research-based. Some commenters adding a new criterion (C)(3)(ii) to (C)(3)(iii), this commenter suggested suggested that the definition of this term encourage States to support that the data be available instead to should state that the purposes of these participating LEAs and schools that are evaluation contractors and State and systems are to: Ensure that every using local instructional improvement Federal officials. student has access to instructional systems to provide effective professional Discussion: We appreciate the materials that are current and aligned to development to teachers, principals, commenter’s concern about the these standards; differentiate and administrators on how to use these resources needed to share data with instruction; provide individualized systems and the resulting data to researchers. However, we believe it is learning; gather input and feedback support continuous instructional very important that researchers, from stakeholders; translate data into improvement. We are also clarifying, in consistent with FERPA, including 34 knowledge; drive innovation; use criterion (C)(3)(i), that the purpose of CFR Part 99, be able to conduct studies knowledge to create networks of best instructional improvement systems is to to improve instruction. We therefore practices; and inform decision-making. provide educators with the resources decline to make the recommended Discussion: In response to these they need, as well as the information change to make the data available only comments, we are clarifying the
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definition of instructional improvement the flexibility to define its own alternative routes to certification systems. However, we are not specifying measures that are tailored to the context involving limited amounts of additional purposes of instructional of its statewide longitudinal data coursework, one commenter disagreed, improvement systems, as this could system. and a third commenter specifically inadvertently discourage States and Changes: None. recommended requiring substantive LEAs from developing new and Comment: One commenter suggested coursework in reading and math content innovative strategies for addressing that criterion (C)(3)(iii) require and teaching methods. students’ learning needs. minimum evidence to ensure that Several commenters recommended In response to the commenters who competing applications are judged in a that the definition include a indicated that instructional consistent manner. Another commenter requirement that all alternative routes to improvement systems should be recommended that minimum evidence certification ensure that graduates of research-based, we believe that much should include the adoption and such programs have the skills to address research has been done on the publication of procedures for the the needs of all students. One effectiveness of using data to inform request and release of longitudinal data commenter expressed concern that instructional decisions. Instructional for research purposes. In addition, this alternative routes to certification, given improvement systems provide teachers commenter suggested that evidence their shortened timeframe, are not and instructional leaders with the include the State’s partnerships with designed to ensure that teachers develop evidence they need to make informed national researchers to evaluate the the skills needed to effectively instruct instructional decisions. Therefore, such effectiveness of the instructional students with disabilities. The systems are a critical element of any practices in each participating LEA. commenter recommended strengthening classroom-based, evidence-driven Discussion: We believe that the basic both traditional and alternative route approach to instruction. elements of a plan, as specified in preparation programs so that all Changes: We have revised the Application Requirement (e), should be teachers are more skilled in teaching definition of instructional improvement sufficient to yield consistent judging on students with disabilities. systems to reference that such systems this criterion. We therefore decline to Two commenters sought changes are ‘‘technology-based tools and other require the specific minimum evidence aimed at ensuring that graduates of strategies that provide teachers, suggested by the commenters. alternative routes to certification receive the same level of certification as principals, and administrators with D. Great Teachers and Leaders meaningful support and actionable data teachers and leaders who complete to systemically manage continuous Selection Criterion (D)(1): Providing traditional preparation programs. instructional improvement * * *.’’ In High-Quality Pathways for Aspiring Similarly, a few commenters addition, we have included summative Teachers and Principals (Proposed recommended that the Department assessments as an additional example of Criterion (C)(1)): require States to verify that teachers information gathering on instructional Comment: Many commenters certified through alternative routes to improvement. recommended changes to the proposed certification are treated equally and definition of alternative certification fairly in hiring under all State Performance Measures and Minimum routes. Two commenters suggested regulations and statutes, while another Evidence for Selection Criteria (C)(1), changing the term to ‘‘alternative routes commenter suggested sanctioning States (C)(2), and (C)(3) to certification’’ to be consistent with that treat alternative routes to Comment: Several commenters the terminology in criterion (D)(1). certification as a ‘‘route of last resort.’’ recommended specific performance Some commenters recommended that On the other hand, one commenter measures for criteria (C)(1), (C)(2), and the definition refer to school districts stated that teachers certified through (C)(3). For instance, one commenter and nonprofit organizations as providers alternative routes generally should not recommended that data performance of programs offering alternative routes be assigned to high-need schools measures include indices or rankings on to certification. A few commenters because of their limited experience. districts’ and schools’ actual provision sought to ensure that programs offering Discussion: In response to these of basic resources and opportunities that alternative routes to certification be comments, the Department is making a the ARRA contemplates. Another selective in accepting candidates into number of changes to the definition of commenter encouraged the Department their programs. Many commenters alternative certification routes. First, we to include a performance measure that objected to defining an alternative route agree that the various terms used in the States must ensure data are in a format to certification as one that includes Race to the Top program should be and in a language that families can clinical or student teaching experience, consistent; therefore, we are changing access and understand, consistent with claiming that such experiences are the proposed term ‘‘alternative the myriad roles parents are required to characteristic of traditional preparation certification routes’’ to ‘‘alternative play under the ESEA. Another programs, and that other kinds of routes to certification’’ in this notice. commenter recommended that training, such as intensive mentoring We also agree that the NPP was unclear performance measures for criterion support during the first months of regarding providers of alternative routes (C)(2) include the results of surveys of teaching, are more valuable than clinical to certification, and are changing the stakeholders. One commenter suggested or student teaching experiences. definition to clarify that qualified that performance measures be used to However, one commenter supported providers of States’ teacher and evaluate the extent to which the output field-based experiences for principals, administrator preparation programs from the statewide longitudinal data and other commenters stated that include both institutions of higher system is geared to stakeholder needs. administrators seeking alternative routes education and other providers that Discussion: A State may propose its to certification should have prior operate independently from institutions own performance measure(s) for the teaching experience. of higher education. In addition, we section on Data Systems to Support Commenters also had different views agree that providers of alternative routes Instruction. Rather than requiring on the level and type of coursework that to certification, as with all preparation particular performance measures for this should be part of alternative routes to programs, should be selective in section, we are choosing to give a State certification. One commenter supported enrolling individuals in their programs
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and, therefore, are changing the preparation programs, and we are recommended that the Department not definition to ensure that qualified changing the definition to reflect this require States to require alternative providers of teacher and principal view. routes for principals. A few commenters preparation programs are selective in The Department agrees that there is a argued that research shows that the candidates they accept. need to strengthen preparation programs alternative routes have not been as The Department believes it is to prepare teachers and principals to effective as traditional programs. One important to provide prospective meet the needs of all students. We are commenter suggested that the teachers and principals with direct revising the definition of alternative Department focus on the quality of school and classroom experiences as routes to certification to clarify that pathways to certification rather than the part of their preparation. Because such routes should prepare teachers and number of those pathways. Multiple alternative routes to certification are principals to address the needs of all commenters suggested that States accelerated and vary in delivery models, students, including English language develop common standards of there are a variety of ways, in addition learners and students with disabilities. performance for those entering the to clinical or student teaching Changes: We have changed the term profession, regardless of the route taken. experiences, to provide this experience, ‘‘alternative certification routes’’ to One commenter recommended that the such as through practicum and job ‘‘alternative routes to certification.’’ We Department establish safeguards to embedded experiences, coupled with also have made the following changes: ensure that alternative routes intensive mentoring or support during (1) Revised clause (a) to clarify that successfully prepare candidates to meet the first months of teaching, as ‘‘other providers’’ refers to ‘‘other a consistent set of standards that govern suggested by the commenters. We agree providers operating independently from teacher licensure. A few generally with the commenters and are revising institutions of higher education’’; (2) supportive commenters recommended the definition to refer to school-based added a new clause (b) to clarify that monitoring these routes to ensure experiences and ongoing support such alternative routes to certification quality programs, and requiring States as effective mentoring and coaching. programs must be selective in accepting to provide evidence of a quality control As to the extent of the coursework candidates; (3) re-designated proposed process for their certification programs. required by programs providing clause (b) as new clause (c) and changed Discussion: The Department agrees alternative routes to certification, the ‘‘clinical/student teaching experiences’’ that we should encourage the creation of Department believes that States are in to ‘‘supervised, school-based high-quality pathways for aspiring the best position to determine the experiences and ongoing support such teachers and principals through both courses and coursework that could be as effective mentoring and coaching;’’ traditional and alternative routes to reduced or limited as a part of any (4) re-designated proposed clause (c) as certification. We are therefore adding alternative route to certification new clause (d); and (5) re-designated criterion (D)(1)(iii), under which States program, consistent with the needs of proposed clause (d) as new clause (e) will be rewarded for having a process local schools, the accelerated nature of and revised it to clarify that upon for monitoring, evaluating, and alternative routes to certification, and completion, programs providing identifying areas of teacher and the wide range of previous education alternative routes to certification must principal shortage and for preparing and experience that candidates bring to award the same level of certification teachers and principals to fill these these programs. The Department, that traditional preparation programs areas of shortage. therefore, declines to change the award upon completion. We have also At the same time, we believe it is definition to specify the amount or type revised the definition of alternative important to retain the original of coursework that must be included in routes to certification to clarify that substance of proposed criterion (C)(1), programs providing alternative routes to such routes should include ‘‘standard regarding alternative routes to certification. We are specifying in the features such as demonstration of certification, for two reasons. First, to final definition, however, that subject-matter mastery, and high-quality increase the supply of high-quality alternative routes to certification should instruction in pedagogy and in talent entering the field of education we include standard features such as addressing the needs of all students in must reduce the barriers to entry into demonstration of subject-matter mastery the classroom including English the education profession, especially for and high-quality instruction in language learners and students with high-achieving individuals, such as pedagogy. disabilities.’’ individuals who have changed careers We also believe that programs Comment: Many commenters and recent college graduates who have providing alternative route to suggested that the Race to the Top the potential to be good educators. certification should not award levels of competition places too much emphasis Alternative routes to certification are certification that are different from the on alternative routes to certification and typically optimized for such new certifications available from traditional recommended that the Department entrants into the profession. Second, the preparation programs, which could eliminate the focus on alternative routes Secretary believes that competition limit the opportunities for teachers to and expand the criterion to include between traditional and alternative teach and leaders to lead; rather, multiple routes. Several commenters certification providers will help alternative routes to certification expressed concern that alternative increase the quality of all programs. To programs, whether for teachers or routes to certification are not as effective provide clarity, and to emphasize the principals, should be considered as traditional routes. Those commenters importance of alternative routes actually different pathways to certification with argued that alternative routes to being in use, we are separating proposed the same rigor as other State-approved certification do not provide the criterion (C)(1) into two criteria, (D)(1)(i) routes. The Department’s view is that necessary skill sets to impact teaching and (D)(1)(ii). States, LEAs, and schools should treat and learning, and do not attract To further support the notion that all individuals prepared through State- educators with the necessary teacher and administrator preparation approved alternative routes to background to provide instructional programs must train candidates to certification in the same manner as leadership. A few commenters become high-performing professionals, those prepared and certified through questioned whether criterion (D)(1) is we proposed in the NPP and establish traditional teacher and principal necessary. One commenter in this final notice, criterion (D)(4). This
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criterion is intended to shine a light on achievement in STEM areas. However, meet the specific personnel needs of the quality of all preparation programs we do not believe it is necessary to those LEAs and schools. in the State by providing both potential require that States demonstrate the Discussion: The Department agrees candidates and schools recruiting extent to which their alternative routes that creating partnerships between graduates with valuable information to certification for STEM teachers utilize effective teacher preparation programs about which programs are actually best nationally recognized models. We and high-need LEAs and schools could preparing candidates for success. We are expect that all alternative routes to be an effective strategy to meet also adding criterion (D)(4)(ii), which certification, including those for STEM personnel needs. As discussed earlier, encourages States to expand preparation teachers, would include standard we are adding criterion (D)(1)(iii), which and credentialing options and programs features such as demonstration of is focused on identifying areas of that are successful at producing subject-matter mastery, and high-quality teacher and principal shortage and effective teachers and principals. instruction in pedagogy and in preparing teachers and principals to fill Together, we believe that criteria addressing the needs of all students in them. States could address part of this (D)(1) and (D)(4) provide a combination the classroom including English criterion by establishing the of rewards, incentives, and transparency language learners and student with partnerships suggested by the that could result in significant quality disabilities. As previously stated, we are commenter. improvements in educator preparation adding language to the definition of Changes: None. and recruitment. alternative routes to certification that Selection Criterion (D)(2): Improving Finally, we do not believe we should clarifies this point. Teacher and Principal Effectiveness remove principals from this criterion. Changes: None. Based on Performance (Proposed Criterion (C)(2)): Well-prepared principals are critical to Comment: Two commenters providing the instructional leadership Comment: Several commenters recommended that a portion of the Race recommended requiring that teacher necessary to support teaching and to the Top funds be used to promote learning in our schools. We know that and principal evaluations be conducted new approaches to alternative routes to at the local level and that States only chronically underperforming schools certification, incentivizing existing too often have poor leadership, and that provide support rather than be directly programs to adopt research-based and involved in the evaluation process. poor leadership drives away good effective strategies. teachers. The focus on principal Many commenters also stated that the Discussion: The Department consequences of those evaluations (e.g., preparation is therefore critical. recognizes that there are many research- Changes: Criterion (D)(1) now reads, performance pay) should also be based, innovative practices that can decided at a local level. Those ‘‘Providing high-quality pathways for help teachers, principals, and others aspiring teachers and principals: The commenters argued that local school improve student achievement. Nothing systems are better able to identify extent to which the State has— in this notice prevents States from (i) Legal, statutory, or regulatory effective and ineffective educators, engaging in or supporting such provisions that allow alternative routes allowing for meaningful comparisons innovation. The Department notes that to certification (as defined in this and interpretations across schools. it recently announced proposed notice) for teachers and principals, Another commenter recommended priorities, requirements, definitions, and particularly routes that allow for adding an assurance encouraging States selection criteria for the Investing in providers in addition to institutions of to provide local control to principals Innovation Fund. Established under higher education; over issues such as hiring, leadership (ii) Alternative routes to certification section 14007 of the ARRA, the team appointments, school-based (as defined in this notice) that are in Investing in Innovation fund will funding, and scheduling flexibility. Two use; and provide competitive grants to expand commenters suggested replacing (iii) A process for monitoring, the implementation of innovative ‘‘differentiating’’ in the title of criterion evaluating, and identifying areas of practices that show the promise of (D)(2) (proposed criterion (C)(2)) with teacher and principal shortage and for significantly improving K–12 student ‘‘evaluating.’’ Other commenters stated preparing teachers and principals to fill achievement for high-need students, as that the focus of this criterion should be these areas of shortage.’’ well as help close the achievement gap, primarily on improving the performance In addition, we have added criterion and improve teacher and principal of teachers and principals in order to (D)(4)(ii), which encourages States to effectiveness. The grants will allow improve student achievement. ‘‘expand preparation and credentialing eligible entities to expand their work Discussion: It was the Department’s options and programs that are and serve as models of best practices. intent that LEAs would be the entities successful at producing effective LEAs and nonprofit organizations conducting teacher and principal teachers and principals (both as defined interested in developing new evaluations and making informed in this notice).’’ approaches to improve teacher and decisions, based on the evaluations, Comment: One commenter principal effectiveness in meeting the regarding teacher and principal recommended including an additional needs of high-need students and development, compensation, promotion, requirement that States demonstrate the scaling-up such strategies may wish to retention, tenure, and removal. We are extent to which their alternative routes consider applying for an Investing in revising criterion (D)(2) to clarify that for STEM teachers draw upon nationally Innovation grant. participating LEAs (as defined in this recognized models. Changes: None. notice) should perform these functions Discussion: The Department places Comment: One commenter and States should have a plan for great emphasis in Race to the Top on recommended that, instead of asking ensuring that participating LEAs do so. STEM, as evidenced by the fact that we States to show the extent to which they While differentiating performance is have established a competitive encourage alternative routes to an important component of evaluation preference priority for STEM proposals certification, States should be required systems, we agree that criterion (D)(2) is in this notice. We also recognize the to demonstrate the extent to which focused on improving teacher and importance of using models that have teacher preparation programs partner principal effectiveness, and we are shown success in raising student with high-need LEAs and schools to changing the title to make this clear. We
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also have made the development of 1111(b)(2)(C)(v)(II) of the ESEA)’’ from school graduation rates and college evaluation systems (rather than the definition of effective principal. enrollment rates, as well as evidence of differentiation) the centerpiece of this Comment: Many commenters stated providing supportive teaching and criterion by revising (D)(2) to encourage that the proposed definition of effective learning conditions, strong instructional the design and implementation of high- principal relies too heavily on leadership, and positive family and quality evaluation systems, and to standardized test scores as the sole community engagement. We also are promote their use for feedback, measure of effectiveness. Several making minor changes to the definition professional improvement, and commenters recommended that the for purposes of clarification. decision-making. definition be changed to require States Changes: We have changed the Changes: We have revised criterion to expand the definition beyond student definition of effective principal as (D)(2) to clarify that the State’s role is to growth to include multiple measures follows: (a) Replaced ‘‘States may ‘‘ensure that participating LEAs’’ such as effectiveness as a leader; supplement this definition as they see perform the functions described in effective fiscal management; student, fit’’ with ‘‘States, LEAs, or schools must criterion (D)(2). We have also replaced community, and parental engagement; include multiple measures;’’ (b) added ‘‘differentiating’’ with ‘‘improving’’ in effective school safety; evidence of ’’Supplemental measures may include, the title of criterion (D)(2). We have also providing a supportive teaching and for example, high school graduation reframed this criterion so that it focuses learning environment; discipline; rates and college enrollment rates, as on the creation and use of evaluation college matriculation rates; college well as evidence of providing systems. readiness rates; and data on staff supportive teaching and learning Comment: One commenter turnover rates and working conditions. conditions, strong instructional recommended changing criterion One commenter suggested balancing the leadership, and positive family and (D)(2)(i) (proposed criterion (C)(2)(a)) to evaluation of principals by including community engagement;’’ and (c) read ‘‘Establish and provide a clear data from State assessments and other replaced ‘‘so long as principal description of a system to measure data on student learning in all core effectiveness is judged, in significant impact on student growth (as defined in academic subjects, so as to avoid measure by student growth’’ with this notice) that uses a rigorous ‘‘narrowing the curriculum.’’ Other ‘‘provided that principal effectiveness is statistical approach.’’ commenters emphasized the principal’s evaluated, in significant part, by student Discussion: We accept the role in creating a positive school growth.’’ commenter’s suggested language, in climate, engaging students, increasing Comment: One commenter supported part. We do not, however, believe it is the number of effective teachers, the definition of effective teacher and necessary to include in criterion continuous improvement, connecting agreed that student growth should be (D)(2)(i) that the measure of student learning to solving community used as a measure of teacher growth uses a rigorous statistical problems, implementing school-wide effectiveness along with other approach. The definition of student practices that drive substantial student supplemental measures. However, many growth in this notice already provides achievement gains, and preparing that the approaches used to measure students for success in work and post- commenters stated that the proposed growth must be rigorous. We are secondary education. One commenter definition relies too heavily on changing criterion (D)(2)(i) to reflect the suggested supplementing the definition standardized test scores and first part of the commenter’s suggested to state that an effective principal is one recommended requiring supplemental language. We are also clarifying that who demonstrates growth in the number measures. Another commenter growth should be measured for each and percentage of effective and highly recommended giving States the individual student. effective teachers within the school flexibility to define effective teachers Changes: Criterion (D)(2)(i) has been through demonstrated success in using models that make sense in their revised to read, ‘‘Establish clear strategies such as teacher recruitment States. Several commenters suggested approaches to measuring student growth and selection, retention, high quality that the definition include examples of (as defined in this notice) and measure data-driven professional development, supplemental measures such as using it for each individual student.’’ feedback and coaching to individual research-based teaching practices, Comment: One commenter asked for teachers, counseling out, and fair implementing practices that have been clarification regarding the word dismissals. documented in the classrooms of ‘‘overall’’ in the proposed definition of Discussion: The Department believes teachers who are driving substantial an effective principal. that student growth must be a student achievement gains, and using Discussion: The word ‘‘overall’’ in the significant factor in determining feedback and student performance data definition of effective principal refers to principal effectiveness. However, we to improve teaching. the performance of all of the students in agree with commenters that data on Discussion: As noted in our response the school, taken as a whole. The student growth should not be used as to commenters’ concerns that student analogue from the ESEA is the ‘‘all the sole means of evaluating principals growth data should not be used as the students’’ group used in AYP and that States, LEAs, and schools sole means to evaluate principals, we determinations. We are removing the should supplement student growth with agree with commenters that States, reference to section 1111(b)(2)(C)(v)(II) other measures of effectiveness. LEAs, and schools should include of the ESEA from the definition of Accordingly, we are revising the multiple measures in determining effective principal because, as noted definition of effective principal to teacher effectiveness. We are, therefore, elsewhere, a new paragraph (g) in the require that they do so. While we cannot changing the definition to require Application Requirements section of include in the definition all of the States, LEAs, or schools to take into this notice explains that references to measures recommended by the account data on student growth as a ESEA subgroups throughout the notice commenters, we believe it is important significant measure of teacher are the subgroups described in section to include several examples for effectiveness, but also to include 1111(b)(2)(C)(v)(II) of the ESEA. illustrative purposes and are adding multiple measures. We also are adding Changes: We have removed the examples of the following measures in multiple observation-based assessments parenthetical ‘‘(described in section the definition of effective principal: high of teacher performance as an example of
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a supplemental measure in the manner recommended by the into teacher evaluation tools. One definition of effective teacher. commenter. commenter recommended that Changes: We have defined effective Changes: None. educators should use research data and teacher to mean ‘‘a teacher whose Comment: One commenter strongly scientific recommendation as a basis for students achieve acceptable rates (e.g., recommended including high school instruction and developing appropriate at least one grade level in an academic graduation rates as a measure to methods. year) of student growth (as defined in evaluate teacher effectiveness in order Discussion: Throughout this final this notice). States, LEAs, or schools to provide a disincentive to ‘‘creaming’’ notice, the Department encourages must include multiple measures, students and to signal the importance of States, LEAs, and schools to use proven provided that teacher effectiveness is preventing students from dropping out. strategies for improving teacher evaluated, in significant part, by student Discussion: We believe it could be effectiveness and addressing other growth (as defined in this notice). misleading to include high school challenges teachers face. For example, Supplemental measures may include, graduation rates as a required or Invitational Priority 6—School-Level for example, multiple observation-based supplemental measure of teacher Conditions for Reform, Innovation, and assessments of teacher performance.’’ effectiveness, because, more than other Learning focuses on providing schools Comment: One commenter measures, graduation rates typically with flexibility and autonomy, such as reflect the work of many teachers and recommended that the definition of creating school climates and cultures school administrators. Accordingly, we effective teacher be changed to require that remove obstacles to, and actively have included graduation rates as an student growth to be a ‘‘predominant support, student engagement and example of a supplemental measure of measure,’’ rather than a ‘‘significant achievement, and implementing effectiveness in the definitions of measure,’’ of teacher effectiveness. The strategies to effectively engage families effective principal and highly effective commenter noted that using student and communities in supporting the principal. growth as a ‘‘significant measure’’ for academic success of their students. Changes: None. Criterion (C)(3) focuses on using data to judging teacher effectiveness would Comment: One commenter allow other factors to outweigh a improve instruction by increasing the recommended that effective teacher be acquisition, adoption, and use of local teacher’s impact on student defined as a teacher whose students, achievement. instructional improvement systems that overall and for each subgroup, provide teachers and principals with the Discussion: We believe that having demonstrate acceptable rates of student information they need to inform and student growth as a significant factor in growth. The commenter noted that the improve instructional practices; determining teacher effectiveness is a definition of effective principal refers to supporting LEAs and schools that use sufficiently rigorous standard. The ‘‘each subgroup’’ and expressed concern these systems in providing professional revised definition also provides States, that the omission of ‘‘each subgroup’’ in development on how to use these LEAs, and schools with more flexibility the definition of effective teacher could systems to support instructional in determining the appropriate use of be misinterpreted to mean that teachers improvement; and making data supplemental measures without could be deemed effective (or highly available and accessible to researchers outweighing the importance of teachers’ effective) even if their students from so they can evaluate the effectiveness of impact on student growth in different subgroups are not making instructional materials, strategies, and determining teacher effectiveness. sufficient learning gains. approaches. Criteria (D)(2)(iv)(a) and Changes: None. Discussion: The Department included (D)(5) emphasize that the supports Comment: Several commenters the performance of subgroups in the provided to teachers and principals suggested that the definition of effective definitions of effective principal and should be ongoing and informed by data teacher acknowledge and address the highly effective principal because there and evaluations. need to mentor and support new would generally be a sufficiently large Changes: None. teachers who disproportionately work number of students in a particular Comment: One commenter expressed in struggling schools. subgroup at the school level to evaluate concern that data on student growth are Discussion: We agree that professional principal effectiveness. However, it is available only for the limited number of development, including mentoring and generally unlikely that a class would subjects included in the annual coaching, are important aspects of have a sufficient number of students in assessments required under the ESEA. teacher effectiveness. For this reason, any particular subgroup on which to The commenter recommended that we criterion (D)(2)(iv)(a) focuses on using base an evaluation of a teacher’s clarify that alternative measures of evaluations to inform decisions effectiveness. student performance should be used for regarding developing effective teachers Changes: None. teachers teaching subjects that are not and principals, including by providing Comment: Some commenters tested under the ESEA. Another relevant coaching, induction support, recommended that, instead of defining commenter asked how teacher and/or professional development. effective teacher, this notice should effectiveness would be determined Criterion (D)(5) also provides for encourage the use of proven tactics for when there are no data on student evaluation of the extent to which a State improving teacher effectiveness (e.g., growth, such as might be the case for has a high-quality plan for its lowering class sizes or innovative novice teachers and teachers teaching participating LEAs to provide effective, solutions for addressing the challenges subjects or grades that are not tested data-informed professional teachers face). Other commenters under the ESEA. development, coaching, induction, and suggested encouraging States to develop Discussion: As defined in this notice, common planning and collaboration and use performance assessments of the term student growth means the time to teachers and principals. We teachers that reliably and validly assess change in student achievement (as believe these criteria address the need the use of teaching practices known to defined in this notice) for an individual for mentoring and other forms of be associated with student achievement student between two or more points in professional development for teachers gains and to experiment with a range of time. In turn, the definition of student and therefore, are not changing the strategies to incorporate evidence of achievement includes alternative definition of effective teacher in the student learning and accomplishment measures of student performance for
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non-tested grades and subjects. As noted effectiveness. However, he understands ‘‘high rates of student growth’’ may not elsewhere, we are adding, in the and appreciates commenters’ concerns be appropriate for all students. We definition of student achievement, a that student growth should not be used included ‘‘one and one-half grade levels number of examples of alternative as the sole means to evaluate principals in an academic year’’ as an example, not measures of student performance for and teachers. Therefore, we are a requirement. We believe States, LEAs, both tested and non-tested grades and changing the definition of highly and schools should determine what subjects and clarifying that for tested effective principal, consistent with the constitutes a high rate of student grades and subjects, student changes to the definition of effective growth, as the definitions of highly achievement must include a student’s principal, to require States, LEAs, or effective principal (and highly effective score on the State assessments required schools to take into account multiple teacher) clearly permit. We, therefore, under the ESEA (which will allow for measures, in addition to data on student do not believe it is necessary to revise the determination of student growth) growth, in defining a highly effective the definition of student growth, as and may include other measures of principal. We agree with commenters requested by the commenter. student learning as well. Therefore, we that success in attracting, developing, Changes: None. do not believe that additional language and retaining high numbers of effective Comment: One commenter suggested needs to be added to the definition of teachers would be a good measure of a that successful completion of a State- effective teacher. highly effective principal and are adding approved principal licensure program Changes: None. this to the definition along with other that builds the knowledge, skills, and Comment: One commenter expressed examples of supplemental measures. We attitudes to effectively lead people, lead concern that the definition of effective also are making minor technical changes learning, and manage school operations teacher equates effectiveness with for clarity and removing the statutory should be included as a measure of a advancing students one grade level in reference to section 1111(b)(2)(C)(v)(II) highly effective principal. an academic year. The commenter of the ESEA, regarding student Discussion: States, LEAs, and schools stated that this approach ignores the fact subgroups. We are removing the may choose to use successful that research has not identified a statutory reference to the ESEA because, completion of a State-approved standard for student gains in a given as noted elsewhere, a new paragraph (g) principal licensure program as a school year in a given subject. Another in the Application Requirements section supplemental measure of a highly commenter requested clarification of this notice explains that references to effective principal. However, we decline regarding the meaning of ‘‘at least one ESEA subgroups throughout the notice to include it as an example of a grade level in an academic year’’ as used are the subgroups described in section supplemental measure in the definition in the definition of effective teacher. 1111(b)(2)(C)(v)(II) of the ESEA. of a highly effective principal because Another commenter inquired whether Changes: We have changed the we believe that principal effectiveness is States that use summative tests to definition of highly effective principal to best determined by measuring results measure one or more years of student read as follows: ‘‘Highly effective and outcomes. growth would need to change their principal means a principal whose Changes: None. assessment system. students, overall and for each subgroup, Comment: Some commenters Discussion: We included ‘‘at least one achieve high rates (e.g., one and one- commended the Department for grade level in an academic year’’ as an half grade levels in an academic year) of focusing the definition of teacher example of an acceptable rate of student student growth (as defined in this effectiveness on student achievement growth in the definition of effective notice). States, LEAs, or schools must and growth. Other commenters teacher (and effective principal). We include multiple measures, provided recommended adding language that recognized that this example of an that principal effectiveness is evaluated, would allow States and LEAs to acceptable rate of student growth may in significant part, by student growth (as supplement student growth with not be appropriate for all students and defined in this notice). Supplemental multiple measures determined on the therefore, did not include it as a measures may include, for example, State or local level. Other commenters requirement but rather as an example. high school graduation rates; college suggested that States and LEAs be We believe States, LEAs, and schools enrollment rates; evidence of providing required to supplement their definitions should determine what constitutes an supportive teaching and learning of student growth with multiple acceptable rate of student growth for conditions, strong instructional measures. Commenters also purposes of assessing teacher (or leadership, and positive family and recommended that such measures principal) effectiveness. community engagement; or evidence of include the use of evidence-based Changes: None. attracting, developing, and retaining practices for improving student Comment: As with the definition of high numbers of effective teachers.’’ achievement, the use of feedback and effective principal, many commenters Comment: One commenter noted that professional development opportunities, expressed concern about using student the definition of highly effective and leadership activities such as growth as the sole measure for defining principal refers to ‘‘high rates of student mentoring or leading an instructional a highly effective principal. Some growth’’ and recommended modifying community. commenters stated that a good measure the definition of student growth One commenter did not believe the of a highly effective principal is success accordingly. definition should include a teacher’s in attracting, developing, and retaining Discussion: We believe that States’ commitment and ability to use feedback effective teachers. Another commenter, definition of highly effective principal and performance data to improve however, stated that significant growth should demonstrate high rates of instructional practices. The commenter in student achievement would suffice as student growth for their students reasoned that a teacher who improves evidence of a highly effective principal’s overall, and for each subgroup. The student achievement is using (1) ability to improve teacher effectiveness. Department believes that one and one- practices that are both effective for Discussion: As noted earlier, the half grade levels of growth in an student learning and healthy for social Secretary believes that student growth academic year is a good example of a and emotional development of students must be included as a significant factor high rate of student growth. We and (2) feedback to improve practice. in evaluating principal and teacher recognize, however, that this example of One commenter urged the Department
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to have ‘‘an equity focus on those therefore are an invalid measure of learners. One commenter warned that current highly qualified teacher proxies effectiveness. the use of a growth-based model could that have some research base grounded Discussion: We believe students’ make teachers unwilling to serve in student achievement: Novice and out standardized test scores are one of many students with disabilities. Some of field teaching.’’ Another commenter measures that can be used to determine commenters urged the Department to suggested that the definition provide student growth. However, we recognize require specific models, such as value- individual school districts with the that teacher effectiveness should not be added, while others urged the flexibility to establish policies to determined solely on the basis of Department not to require specific determine whether a teacher is highly standardized test scores, which is why models in order to leave States with the effective in order to ‘‘recognize that a we are requiring, in this final notice, the flexibility to develop their own wide range of conditions can vary from use of student growth as a significant measures of student growth. One district to district that would make a factor in teacher evaluations that must commenter was concerned that the state-wide definition inappropriate for include multiple measures. definition ‘‘amounts to another all or evaluation, promotion, or compensation Changes: None. nothing model’’ and pointed out that purposes.’’ Comment: Commenters stressed that research on student growth cautions Discussion: We agree with it is imperative that there is common against making judgments about student commenters that States, LEAs, and ground on how to develop, fairly growth using solely two data points, and schools should be required to compensate, and accurately evaluate suggested that we reconsider this supplement their definition of a highly teachers. A few commenters stated that approach. effective teacher with multiple there should be collaboration between Discussion: Our purpose, in the measures. We are, therefore, revising the teachers and principals in determining context of a competitive grant program definition to require that States, LEAs, appropriate measures for evaluation. intended to provide leading-edge States or schools include multiple measures. Discussion: We agree about the with incentives to develop and test In addition, we are including examples importance of involving teachers and innovative education reform ideas, is to of supplemental measures that States, principals in the design and give States freedom to create their own LEAs, and schools might use, including development of these evaluation systems for measuring student growth leadership roles. systems, and are adding in this final within a few key parameters. We believe notice language requiring such systems Changes: We have revised the that the proposed definition strikes this to be designed and developed with definition of highly effective teacher to balance and that, therefore, significant teacher and principal involvement. mean a teacher whose students achieve changes are not needed. We Changes: We have revised criterion acknowledge that LEAs or schools may high rates (e.g., one and one-half grade (D)(2)(ii) to read, ‘‘Design and reasonably want to measure student levels in an academic year) of student implement rigorous, transparent, and growth using more than two data points. growth (as defined in this notice). fair evaluation systems for teachers and We are changing the phrase ‘‘two points States, LEAs, or schools must include principals that (a) differentiate in time’’ to ‘‘two or more points in time’’ multiple measures, provided that effectiveness using multiple rating to permit the use of interim assessments teacher effectiveness is evaluated, in categories that take into account data on or achievement data collected across significant part, by student growth (as student growth (as defined in this multiple years. We are also editing the defined in this notice). Supplemental notice) as a significant factor, and (b) are second sentence for clarity; this measures may include, for example, designed and developed with teacher includes deleting the phrase ‘‘in order to multiple observation-based assessments and principal involvement.’’ increase the construct validity and of teacher performance or evidence of Comment: One commenter generalizability of the information.’’ leadership roles (which may include recommended that the Department Changes: We have revised the mentoring or leading professional replace the word ‘‘rating’’ with definition of student growth to read as learning communities) that increase the ‘‘personnel evaluation’’ to account for a follows: ‘‘Student growth means the effectiveness of other teachers in the more nuanced approach with multiple change in student achievement (as school or LEA. measures. defined in this notice) for an individual Comment: One commenter suggested Discussion: We believe that the student between two or more points in that adopting the definitions of effective reference to ‘‘rating categories’’ in time. A State may also include other teacher and highly effective teacher in criterion (D)(2)(ii) is sufficiently clear measures that are rigorous and the NPP would be at odds with the that the criterion does not need to be comparable across classrooms.’’ value-added system prescribed in the revised. Comment: Numerous commenters State Fiscal Stabilization Fund. Changes: None. expressed their support for evaluating Discussion: The definitions of Comment: A large number of teachers and principals based on effective teacher and highly effective commenters recommended changes to student achievement or growth. One teacher in this notice are not at odds the proposed definition of student commenter stated that principal with the requirements of the State Fiscal growth. Some suggested that we include evaluations should include an Stabilization Fund. The Race to the Top in the definition the use of non- aggregation of data on student growth. definitions are broad enough to give achievement-based measures of student Several of these commenters, however, States, LEAs, and schools sufficient learning, performance-based or portfolio asserted that student growth data have flexibility to determine the approach to assessments, and interim assessments. limitations, including a lack of common measuring growth that works best for Other commenters suggested including definitions between States, difficulty in them, giving them a variety of ways to in the definition the specific amount of disaggregating a teacher’s effect on comply with the requirements of the growth required. Some commenters student achievement from other effects, State Fiscal Stabilization Fund. supported the proposed definition’s and the lack of data for all grade levels Changes: None. emphasis on individual growth, while and subject areas. Additionally, many Comment: One commenter suggested others called for comparisons among commenters expressed their disapproval that standardized tests are not created to ‘‘like populations,’’ such as students of the proposed criteria regarding using measure teacher effectiveness and with disabilities or English language student achievement data or student
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growth for the evaluation of teachers certification status.4 Another study used principals, and that include student and principals. In support of their data from Chicago public high schools growth as a significant factor in arguments, those commenters cited to estimate the importance of teachers evaluations, will lead to greater trust factors such as the current limitations of on student achievement in mathematics between teachers and principals, enable student assessments, and the and found that, ‘‘one semester with a meaningful decision-making and inadequacy of assessments as an teacher rated two standard deviations support, and push educators to remain evaluation factor. Several of those higher in quality could add 0.3 to 0.5 focused on the ultimate priority — commenters claimed that there is a lack grade equivalents, or 25 to 45 percent of improving student achievement. of research or evidence demonstrating an average school year, to a student’s Changes: None. that the use of such data for teacher and math score performance.’’ The study Comment: One commenter principal evaluations has any positive further concluded that the resulting recommended that the Department impact on teacher, principal, or student teacher quality ratings ‘‘remain encourage the development of research- performance. One commenter disagreed relatively stable for an individual based rubrics and/or innovative teacher with the Department’s statement that ‘‘It instructor over time.’’ 5 A recent study performance evaluation programs. is difficult to predict teacher quality of New York City public charter schools Discussion: We encourage LEAs to be based on the qualifications that teachers concluded that charter schools that pay innovative and draw on rigorous bring to the job. Indeed measures such teachers in part based on evaluations of research in creating evaluation systems; as certification, master’s degrees, and their performance have more positive this is an area that has high leverage and years of teaching experience have effects on student achievement.6 In light is ripe for change. However, in order to limited predictive power on this point.’’ of this evidence, the Department avoid creating a one-size-fits-all policy The commenter argued that the research believes that the best indicator we have or stifling innovation, we decline to the Department cites (i.e., Kane et al.) today for teacher (and by extension name specific tools that LEAs should actually demonstrates that teaching principal) quality is student academic use in their evaluation systems. experience and whether a teacher is growth, but that (as noted above) this Changes: None. Comment: One commenter fully certified does indeed have data must be supplemented with recommended that the Department substantial impact on students’ additional measures. At the same time, consider designating NAEP as the achievement. Other commenters argued the Secretary appreciates that growth standard test for every State to measure that research indicates growth models models are not yet perfect, that there are some challenges to using student growth student achievement. are unstable and too vulnerable to Discussion: Race to the Top will use multiple sources of error and to other data, and that there is more work to be done in this area. For this reason, we do both the NAEP and the assessments student and school factors separate and required under the ESEA to measure apart from student achievement. not stipulate which approach States, LEAs, or schools should use to measure student achievement. Each test has its Additionally, many commenters offered benefits and its drawbacks; together, we reasons for not using student student growth so long as the approach used is rigorous and comparable across believe they will offer the Nation an assessments as a factor in teacher and appropriate ‘‘picture’’ of how Race to principal evaluations, including the classrooms (see the definition of student growth). The criteria and definitions in the Top States are performing. claims that: Using student achievement Changes: None. data to make employment decisions this notice reflect the Department’s belief that student growth data should Comment: One commenter may lead to corruption, students are not recommended removing the phrase held accountable for the results of State be used as a significant factor in determining teacher and principal ‘‘targeted professional development’’ assessments, and that such a policy from criterion (D)(2)(iv)(a) (proposed would detract from other priorities, effectiveness; that evaluation systems should use multiple measures; that criterion (C)(2)(d)(i)). The commenter’s such as equitable distribution of rationale was that the Department effective teachers. Another commenter these evaluation systems should be rigorous, transparent, and fair; and that should promote a comprehensive argued that measuring teacher system for managing and developing effectiveness ignores the organizational they should be designed and developed with teacher and principal involvement. human capital rather than a one-to-one context of schools and inappropriately We do not agree that using student system based on remediation. In defaults to a single measure of student growth data as a part of a rigorous, addition, the commenter asserted that test scores as the basis to evaluate, transparent, and fair evaluation system the Department should be explicit that compensate, and dismiss teachers. that is designed and developed with professional development must be for Discussion: Research shows that teacher and principal involvement will the purpose of increasing student teacher quality is a critical contributor lead to corruption or detract from other achievement. to student learning, and that differences priorities. We contend that Discussion: We agree with the between teachers are persistent. Kane et implementing fair and transparent commenter that the term ‘‘targeted al. found in their study that the evaluation systems developed with the professional development’’ does not certification status of teachers (e.g., involvement of both teachers and connote the appropriately broad range certified, uncertified, and alternative of professional development and certified) ‘‘has at most small impacts on 4 See, Kane, Thomas J., Jonah E. Rockoff, and support for teachers and principals student test performance.’’ At the same Douglas O. Staiger (2006), ‘‘What Does Certification originally envisioned by the time, they found that, ‘‘among those Tell Us About Teacher Effectiveness? Evidence Department. We are therefore changing with the same certification status, there from New York City.’’ this criterion to include the phrase are large and persistent differences in 5 Daniel Aaronson, Lisa Barrow, and William Sander (2003), ‘‘Teacher and Student Achievement ‘‘providing relevant coaching, induction teacher effectiveness.’’ They also in the Chicago Public High Schools,’’ Federal support, and/or professional reported that evidence suggests that Reserve Bank of Chicago Working Paper 2002–28. development.’’ We do, however, want to teachers’ classroom performance during 6 Hoxby, Caroline M., Sonali Murarka, and Jenny make clear that in the context of their first two years of teaching is a Kang. ‘‘How New York City’s Charter Schools Affect Achievement, August 2009 Report.’’ Second report criterion (D)(2), we are encouraging more reliable indicator of a teacher’s in series. Cambridge, MA: New York City Charter LEAs and schools to consider how they future effectiveness than their Schools Evaluation Project, September 2009. will use teachers’ and principals’
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evaluations to inform their specific growth data. Several commenters stated designed and developed with teacher professional development plans. In that there is no evidence suggesting that and principal involvement. other criteria, such as (D)(5) and performance pay linked to achievement We also note that the criterion refers (C)(3)(ii), we encourage a broad range of data leads to improved educational to decisions regarding promotion and professional development activities. We outcomes. Several commenters asserted retention as well as compensation also believe that, by specifying that that performance pay places an undue because we believe that great teaching professional development should be emphasis on teachers and principals as and school leadership should be responsive to evaluations that use individuals as opposed to parts of the recognized and rewarded as much as student growth as a significant factor, education system as a whole. One possible, and that talented educators we make clear in this final notice that commenter recommended that Race to should have opportunities for increased professional development should be the Top funds be used to design tests in responsibilities and other retention oriented around supporting teachers pilot districts that could test the incentives, where appropriate, as well and principals in increasing student effectiveness of alternative as for additional compensation. achievement. compensation programs. Changes: We have reorganized Changes: We have split proposed criterion (D)(2) to make it clearer that criterion (C)(2)(d)(i) into two parts. We Discussion: The Department believes the decisions discussed in criterion have combined the first part with that we need to do much more to shine (D)(2)(iv) should be based on the proposed criterion (C)(2)(c), resulting in a spotlight on and reward excellence in evaluation systems discussed in criterion (D)(2)(iii), which reads, teaching and school leadership, and that criterion (D)(2)(ii) and the evaluations ‘‘Conduct annual evaluations of teachers one way to do so is through discussed in criterion (D)(2)(iii). We and principals that include timely and compensation and promotion. At the have also added ‘‘retaining’’ to the list constructive feedback; as part of such same time, we recognize that rewarding of decisions in criterion (D)(2)(iv)(b). evaluations, provide teachers and excellence while fulfilling the demands Comment: Numerous commenters principals with data on student growth of fairness and the need to maintain a argued that performance pay would for their students, classes, and schools.’’ collaborative school environment is a create perverse incentives for teachers to The second part has been designated delicate task that requires cooperation work only with student groups most criterion (D)(2)(iv)(a), which specifies between LEA leadership, principals, likely to demonstrate improvement, that evaluations should inform and teachers. thereby marginalizing difficult-to-teach decisions regarding ‘‘Developing We also recognize that pay-for- student groups and communities, teachers and principals, including by performance systems in education are including low-income communities, providing relevant coaching, induction controversial and spark much debate. English language learners, and students support, and/or professional Some States, LEAs, and schools have with disabilities. Discussion: As contemplated in the development.’’ experimented with such models and notice, performance pay would be based Comment: A few commenters shown relative success and promise, on teacher and principal evaluations recommended that the Department while others have experienced less that, as discussed previously, use include a clear statement indicating that encouraging results. The ARRA also student growth—not raw student State reform plans should specify that includes funds for the Teacher Incentive achievement data or proficiency teachers and principals will be assessed Fund, which will award grants to LEAs levels—as a significant factor. Thus, on more than a single year of data. to develop performance-based Discussion: We believe it is important teachers whose pupils start behind their compensation models. While research to use accurate data when evaluating peers or who are working with students on pay-for-performance plans is limited, teacher and principal performance, and with disabilities or English language there is evidence to suggest that a well- that those evaluations should be done at learners are in no way penalized. This designed performance-based pay system least annually and should involve final notice also gives States, LEAs, and/ can lead to improved student timely and constructive feedback. To or schools sufficient flexibility to take achievement.7 Studies indicate that the make it clear, however, that annual these concerns of commenters into most effective and successful pay-for- evaluations do not have to be conducted account when creating systems for performance systems incorporate factors based on only one year of information, evaluation, compensation, and such as using multiple measures for we have revised the definition of promotion. We also note that the evaluating performance; making student student growth to clarify that student Department is placing an emphasis on growth just one measure of growth should be measured using attracting teachers to hard-to-staff performance; having a clearly identified achievement data between ‘‘two or more subjects, specialty areas, and schools in purpose (e.g.. improving student points in time,’’ rather than between criterion (D)(3). achievement, improving recruitment only two points in time. Changes: None. Changes: We have revised the and retention, or attracting teachers to Comment: Several commenters definition of student growth so that it hard-to-staff schools); and creating recommended including language means the change in achievement data collaboration among teachers, requiring States to provide additional for an individual student between ‘‘two principals, and other stakeholders. The responsibilities for effective teachers. or more points in time.’’ Department believes that criterion (D)(2) Many of the commenters included Comment: A number of commenters incorporates these factors by specifying specific examples of professional supported the use of student growth that evaluation systems for teacher and opportunities States or LEAs should data in determining compensation and principals should use multiple provide to highly effective teachers, promotions. A few commenters stated measures, take into account student such as serving as a community liaison, that the Department needs to specify growth as a significant factor, and be induction leader, or curriculum how to structure performance pay (e.g., developer after earning an endorsement how to offer it for teachers of subjects 7 See e.g., Joshua H. Barnett, Gary W. Ritter, on their teacher’s license. Marcus A. Winters, and Jay P. Greene, ‘‘Evaluation that are not tested). However, many of Year One of the Achievement Challenge Pilot Discussion: The Department believes commenters expressed their opposition Project in the Little Rock Public School District,’’ that it is critical to adequately to pay based on student achievement or University of Arkansas, January 2007. compensate and promote our best
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teachers and principals. These teachers and principals. Criteria teachers and principals must only occur professionals are the role models and (D)(2)(iv)(a) and (D)(5) also encourage after they have received ample support leaders of our schools and are essential States to support LEAs in providing and opportunities to improve their to implementing effective educational professional development and performance yet have failed to do so. A reforms and improving student undertaking other efforts, especially few commenters recommended that we achievement. For these reasons, this those informed by data and evaluations, clarify the term ‘‘ample opportunities’’ notice makes clear that highly effective to make their existing teachers more and specify the amount of time that low- teachers and principals should have an effective. We are also revising criterion performing teachers should have to opportunity to obtain additional (D)(2)(iv)(b) to specifically clarify that improve their performance (e.g., as one compensation and responsibilities for teacher and principal evaluations school year). their high performance. should inform retention decisions. Discussion: Providing teachers and We believe that LEAs and schools, in Changes: We have revised criterion principals with the needed support to collaboration with their teachers and (D)(2)(iv)(b) to read as follows, improve the effectiveness of instruction principals, are best situated to ‘‘Compensating, promoting, and and student outcomes is a critical determine the timing and types of retaining teachers and principals, element of Race to the Top, and additional responsibilities that should including by providing opportunities for removing ineffective professionals from be given to their staff and that it would highly effective teachers and principals schools is important as well. be inappropriate for the Department to (both as defined in this notice) to obtain Race to the Top includes a number of set requirements around this issue. additional compensation and be given criteria, in addition to criterion (D)(2), Changes: None. additional responsibilities.’’ that are dedicated to teacher and Comment: One commenter Comment: Many commenters principal professional development and recommended replacing the word supported using evaluations in making supports; parts of criteria (B)(3) and ‘‘tenure’’ with ‘‘continuing employment employment decisions, such as those (C)(3) and all of criterion (D)(5) concern status’’ for the sake of clarity. regarding teacher and principal tenure, this issue, including discussions of Discussion: The Department believes dismissal, displacement, and layoff. professional collaboration and planning the word ‘‘tenure’’ is more widely Most of these commenters supported time, individualized development understood and declines to make the using multiple measures in these plans, training and support in the suggested change. evaluations and not basing such analysis and use of data, classroom Changes: None. employment decisions primarily or observations with immediate feedback, Comment: Several commenters solely on assessment results. and other activities critical to expressed concern that, while proposed Discussion: We agree that rigorous, supporting and improving teacher and criterion (C)(2)(iii) mentions using transparent, and fair evaluation systems principal capacity. These supports are information to grant tenure and dismiss should be used to inform a variety of paired, in the Race to the Top criteria, teachers, it does not focus on the need decisions, including development, with criteria that focus on rigorous, fair to retain teachers. One of these compensation, retention, tenure, and transparent teacher and principal commenters stated that dismissals are certification, and removal. As discussed evaluation systems that should include going to involve a very small percentage earlier, we are requiring that evaluation providing feedback on areas where of teachers and principals. The systems include multiple measures and professional improvements are needed. commenter further stated that both rural that student growth be a significant We decline to specify the amount of and urban schools may have difficulty factor, and we are revising criterion time teachers should be given to make attracting and retaining effective (D)(2) to make it clearer that the improvements in their performance, teachers. One commenter cited the decisions under criterion (D)(2)(iv) beyond specifying that they should have difficulties in attracting and retaining should be based on the evaluation ‘‘ample opportunities to improve.’’ It is effective or highly effective teachers in systems discussed in criterion (D)(2)(ii) the responsibility of the LEA and school extremely rural areas. The commenter and the evaluations discussed in to provide their students with effective further stated that school districts in criterion (d)(2)(iii). For purposes of teachers and principals, to provide their rural areas are forced to hire beginning clarity, we are dividing proposed teachers and principals with effective teachers who cannot be considered criterion (C)(2)(d)(iii) into two criteria support, and to take action when effective or highly effective as defined and adding decisions regarding full appropriate. We have deleted the phrase in the NPP. A couple of commenters certification to one of the criteria. ‘‘but have not done so’’ to reflect this. believed that robust, strong, and fair Changes: Proposed criterion Changes: We have removed the evaluation systems are important for (C)(2)(d)(iii) has been reorganized as phrase ‘‘but have not done so’’ from attracting and retaining highly qualified, criteria (D)(2)(iv)(c) and (D)(2)(iv)(d). criterion (D)(2)(iv)(d). effective teachers and principals to Criterion (D)(2)(iv)(c) addresses the use Comment: One commenter argued high-poverty schools. of evaluation systems to inform that aspects of criterion (D)(2) (proposed Discussion: The Department concurs decisions regarding whether to grant criterion (C)(2)) may contravene the that recruiting and retaining effective tenure and/or full certification to Personnel Evaluation Standards that, and highly effective teachers and teachers and principals, and criterion according to the commenter, have been principals is critical for States and LEAs (D)(2)(iv)(d) addresses removing federally accredited. to meet their goals for education reform ineffective tenured and untenured Discussion: The Personnel Evaluation and improve student achievement, teachers and principals after they have Standards referenced by the commenter particularly in high-poverty and/or had ample opportunities to improve. are not federally accredited or approved high-minority schools. For this reason, For both criteria, we have clarified that by the Department. They are voluntary criterion (D)(3) discusses the equitable these decisions should be made using guidelines published by a private distribution of effective teachers and rigorous standards and streamlined, organization and are in no way binding principals in high-poverty and/or high- transparent, and fair procedures. on the Department or its grantees. minority schools and encourages States Comment: Some commenters Changes: None. and LEAs to provide incentives and suggested that the Department should Comment: A few commenters strategies to attract and retain effective clarify the statement that the removal of recommended that States should have a
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flexible amount of time to develop existing State statutes concerning tenure between States, we have opted to give evaluation systems that link data on and dismissal. A few commenters States greater flexibility in defining student growth to teachers and recommended requiring States to these terms than the commenter principals in order to allow time for the comply with local collective bargaining recommended, and are asking each State development of advanced assessment agreements or involve employee to define the terms consistent with its systems. Other commenters representatives where there is no Teacher Equity Plan. recommended that this notice reflect an collective bargaining agreement. One Changes: We have added definitions understanding of the timeframe that commenter specifically suggested of high-minority school and low- may be necessary to build a requiring that collective bargaining be minority school, both of which are comprehensive and fair teacher and the vehicle for implementing defined ‘‘by the State in a manner principal evaluation system that takes performance pay schemes in local consistent with its Teacher Equity Plan. student growth data into account given school districts. The State should provide, in its Race to the state of the research in this area and Discussion: In order to successfully the Top application, the definition the practical considerations in implement many of the plans under used.’’ establishing such a system. The criterion (D)(2), LEAs in collective Comment: One commenter commenter stated that the proposed bargaining States will need to work recommended defining low-poverty criterion would compel States to rush collaboratively with their local unions. school for the purposes of reporting and into imposing current value-added Because this work and collaboration are accountability related to ensuring the indicators of student learning on current so important, States will earn points equitable distribution of effective evaluation systems rather than based on the extent to which the local teachers and principals under criterion developing new advanced systems. union leadership in their participating (D)(3) (proposed criterion (C)(3)). Discussion: The notice does not state LEAs have signed the MOUs between Discussion: The Department agrees a specific timeframe for States to the States and the LEAs indicating their that a definition of low-poverty school, develop assessment systems and teacher intent to work in partnership with the in conjunction with the definition of and principal evaluation systems. LEAs in implementing the plans, high-poverty school proposed in the Through their applications, States must including by addressing contractual NPP and retained in this notice, would provide, for each Reform Plan Criterion issues such as local bargaining help ensure that States are using the in this notice, a detailed plan for the use agreements. (See criterion (A)(1)). In same standards to inform their efforts to of grant funds that includes, among addition, criterion (D)(2)(ii) creates ensure that students in high-poverty other things, (1) the key activities to be incentives for LEAs to design and schools have equitable access to highly undertaken; (2) the timeline for implement rigorous, transparent, and effective teachers and principals and are implementing the activities; and (3) fair evaluation systems with teacher and not served by ineffective teachers and annual targets (where applicable) with principal involvement, while criterion principals at higher rates than other respect to performance measures for the (D)(2)(iv)(d) encourages LEAs to make students. We are, therefore, adding a four school years beginning with the decisions regarding removal using definition of low-poverty school, 2010–2011 school year. (See rigorous standards, and streamlined, adapted from similar language in the Application Requirements, section (e), transparent, and fair procedures. for a complete list of requirements). It is Changes: None. ESEA. through this process that States have the Selection Criterion (D)(3): Ensuring Changes: We have included the flexibility to define the timeframe for Equitable Distribution of Teachers and definition of low-poverty school in this implementing their activities, including Principals (Proposed Criterion (C)(3)): notice, defining the term to mean, systems development. States’ Comment: One commenter ‘‘consistent with section applications will be judged, in part, on recommended adding a definition of 1111(h)(1)(C)(viii) of the ESEA, a school whether their activities and targets are high-minority school and defining the in the lowest quartile of schools in the ambitious yet achievable. As a result, term as a school in the highest quartile State with respect to poverty level, we believe that this final notice of schools in a State with respect to using a measure of poverty determined appropriately encourages States and enrollment of minority students. The by the State.’’ LEAs to strike the right balance between commenter also recommended adding a Comment: Multiple commenters speed and thoughtfulness. We definition of low-minority school and suggested that the Department take emphasize, however, that States should defining the term as a school in the further steps toward ensuring the not wait to develop improved lowest quartile of schools in a State with equitable distribution of teachers by evaluation systems until higher-quality respect to enrollment of minority requiring States to have a plan to ensure assessments are available, as doing so students. These comments were in the that low-income and minority students would delay this essential progress by context of a recommendation by the are not taught by ineffective teachers at years and, in the process, harm student commenter to add to criterion (D)(3) a higher rates than other students. Other achievement. We expect that these focus on the equitable distribution of commenters recommended that the evaluation systems will improve over effective teachers with respect to high- Department ask States to document their time, as LEAs learn from their own minority schools. efforts to address gaps in teacher quality experiences and from the experiences of Discussion: We agree that it is between high-poverty and low-poverty others, and as States develop higher- important to consider the equitable and high-minority and low-minority quality assessments, the results of distribution of effective teachers with schools. Another commenter which will improve the measures of respect to both high-poverty and high- recommended revising the performance student growth that feed into these minority schools, and we are revising measures for this criterion to include evaluation systems. criterion (D)(3) accordingly. To give the number and percentage of effective Changes: None. greater clarity to this change, we are teachers and principals in high-poverty, Comment: A number of commenters adding definitions of high-minority low-poverty, high-minority, and low- recommended requiring States to school and low-minority school to this minority schools. Along those lines, one include in their plans a commitment to notice. However, in acknowledgment of commenter stated that evidence of adhere to due process rights and the vast demographic differences existing progress was more compelling
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than reform plans and should therefore general concerns about the roles of the ESEA)’’ instead of ‘‘English language be given more weight. States and LEAs. proficiency.’’ Discussion: The Department believes Changes: We have added the phrase Changes: The Department has revised that great teaching and leadership ‘‘in collaboration with its participating criterion (D)(3)(ii) to read, ‘‘Increase the matter tremendously, and that the LEAs (as defined in this notice)’’ to number and percentage of effective inequitable distribution of highly criterion (D)(3). We also have revised teachers (as defined in this notice) effective teachers and principals is a criterion (D)(3)(i) to read, ‘‘Ensure the teaching hard-to-staff subjects and major cause of the achievement gap. We equitable distribution of teachers and specialty areas including mathematics, therefore agree with the commenters principals by developing a plan, science, and special education; teaching that we should take further steps to informed by reviews of prior actions in language instruction educational ensure equitable distribution of effective and data, to ensure that students in programs (as defined under Title III of teachers and principals. To that end, we high-poverty and/or high-minority the ESEA); and teaching in other areas are revising criterion (D)(3)(i) so that it schools (both as defined in this notice) as identified by the State or LEA.’’ addresses the equitable distribution of have equitable access to highly effective Comment: Several commenters effective teachers and principals with teachers and principals (both as defined requested an expansion of hard-to-staff respect to high-minority schools, in in this notice) and are not served by subjects to include additional subjects addition to high-poverty schools. We are ineffective teachers and principals at or programs such as career and also specifying that, in addition to higher rates than other students.’’ technical education, computer science, having equitable access to highly Comment: Some commenters and gifted and talented programs. One effective teachers and principals, recommended requiring that teachers commenter recommended the addition students in high-poverty and/or high- assigned to high-poverty schools with a of over-age students and under-credited minority schools should not be served significant number of English language youth to this definition. by ineffective teachers and principals at learners have dual certification. Discussion: While there are some higher rates than other students. We Discussion: We believe that the nationwide teacher shortages, the list of agree that the performance measures for decision regarding dual certification for hard-to-staff subjects varies from region this criterion should allow for teachers is best left to the States, who to region. The Department has therefore comparisons between high-minority have a better understanding of their own focused its list on national needs, and and/or high-poverty schools and low- demographics as well as whether this is providing States with the flexibility to minority and/or low-poverty schools, critical training is needed for all add other subjects or areas as they see and we are revising the evidence and teachers in such schools or just certain fit. The NPP allowed States or LEAs to performance measures to reflect this. teachers. For this reason, we have identify hard-to-staff subjects other than (See Appendix A: Evidence and decided not to include this specific math and science. In this notice, we are Performance Measures.) requirement. However, as discussed clarifying that they may also identify We appreciate the suggestion from previously, we are revising the hard-to-staff specialty areas beyond commenters that this criterion should definition of alternative routes to those listed. reflect States’ past actions, and we are certification to clarify that these routes Changes: We have revised criterion revising this criterion to specify that the should prepare teachers and principals (D)(3)(ii) by inserting the phrase ‘‘and plans States submit should be informed to address the needs of all students, teaching in other areas as identified by by past actions and data. We understand including English language learners. the State or LEA.’’ the skepticism expressed by Changes: None. Comment: Several commenters argued commenters who note that States have Comment: One commenter expressed that teachers value working conditions had Teacher Equity Plans in place since concern that Race to the Top’s criterion over relocation bonuses. Multiple 2002 and have not made sufficient for ensuring equitable teacher commenters recommended that we progress, but we emphasize that Race to distribution, though well-intended, focus on the value of class size the Top will use States’ performance would have a generally negative impact reduction, improving school safety, and targets to create a level of accountability on struggling schools. repairing school facilities in order to that did not exist for these prior plans. Discussion: The Department intends improve working conditions and Furthermore, we believe that judging for this criterion to improve conditions achieve equity in teacher distribution. State progress to date would be difficult in struggling schools, and does not agree One commenter stressed that States’ given the lack of measures of teacher that filling high-minority or high- Teacher Equity Plans should and principal effectiveness and the poverty schools with highly effective specifically address the steps States will imperfections with the existing input- teachers through equitable teacher take to remedy disparities in resources, based measures, and we believe that distribution strategies would have a services, and opportunities. Multiple asking States to report on their progress negative impact on struggling schools. commenters expressed opposition to using one type of measure and to craft Changes: None. plans that would encourage involuntary plans using another type would be Comment: Multiple commenters transfers of faculty and principals to confusing. Therefore, we choose not to recommended clarifying that special high-poverty schools and arbitrary give more weight to progress to date. At education is an area of teaching, rather abolition of seniority in contracts. The the same time, we encourage States to than a subject. One commenter made a same commenters also expressed build on their successes and learn from similar recommendation regarding support for certain incentives for their experiences in recent years. English language acquisition. teachers in high-poverty schools, We are also clarifying that the State’s Discussion: We agree that special including extended contracts or loan plan for ensuring equitable distribution education and English language forgiveness programs. Many of effective teachers and principals acquisition are areas of teaching, not commenters recommended expanding should be developed in collaboration stand-alone subjects. We are revising the criterion to refer to attracting high- with the State’s participating LEAs. This criterion (D)(3)(ii) to clarify this. We are quality teachers to all classrooms and revision is necessary to ensure also clarifying the criterion to refer to subjects, rather than just hard-to-staff consistency with criteria (D)(2) and ‘‘language instruction education ones. Several commenters (D)(5) and to respond to commenters’ programs (as defined under Title III of recommended that the list of incentives
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and strategies that States might use to including outside labor market plans, such as the equitable distribution ensure equitable distribution of effective opportunities, it may be harder to of teachers and principals in high- teachers and principals should include recruit teachers for some subjects and poverty and/or high-minority schools. professional development and training specialty areas than for others. We We believe that Race to the Top may programs. In fact, multiple commenters believe that State policy should be lead to changes in how LEAs and noted the value of retaining effective responsive to this reality so that hard- teachers’ unions work together within teachers and supporting teachers in to-staff subjects and specialty areas, like the framework of collective bargaining high-poverty schools through long-term other subjects and areas, are filled with to address these issues. However, any investments such as preparation exceptional teachers and leaders. We changes to laws or policies governing programs, mentoring, peer review, and leave it up to States and LEAs to collective bargaining are best wraparound programs, and argued for determine the best methods for determined at the State and/or LEA their superiority over purely monetary achieving this goal, and we have level. incentives or one-size-fits-all provided some illustrative examples in Changes: None. approaches. One commenter suggested criterion (D)(3)(ii) that we believe are Comment: A few commenters supporting teachers in their efforts to appropriate responses to this long- recommended including performance receive National Board Certification and standing problem. measures on the percentage of teachers placing these nationally certified Changes: None. who have taught a minimum number of teachers in high-poverty schools. One Comment: One commenter suggested years, are non-qualified, or are teaching commenter suggested that the that Race to the Top funds could be out-of-subject or out-of-field. Department provide direct guidance on used to bolster recruitment to the Discussion: The Department believes recruitment and retention, including teaching profession by investing in that the performance measures included incentives to persuade high-quality research to determine why many college in this final notice are designed with an teachers who have retired from or left students choose not to enter the appropriate focus on student outcomes. high-need urban schools to return. profession of teaching. We do not believe it is necessary to Discussion: The Department agrees Discussion: While the commenter include these additional requirements, that high-quality working conditions are suggests one possible idea for bolstering but welcome States to propose important for all professionals. In the recruitment, we decline to prescribe additional performance measures where context of criterion (D)(3), ensuring the methods of improving recruitment, but appropriate for their plans. equitable distribution of teachers and encourage applicants to suggest Changes: None. principals, we agree that strategies to approaches that they believe will work Comment: One commenter expressed attract teachers to hard-to-staff schools, in their contexts. concern that Race to the Top lacks the subjects, and specialty areas may Changes: None. adequate funding required for the encompass a range of different Comment: One commenter preparation, recruitment, retention, and approaches. Many of the ideas put forth recommended that in light of the professional development of teachers in the comments could form the basis historical challenges of improving that is necessary to successfully create for States’ strategies to more equitably equitable teacher distribution, we equitable teacher distribution. allocate their teachers. While we have provide additional guidance on how Discussion: The ARRA provides $4.3 not included all of the examples in this States and districts may demonstrate billion for the Race to the Top Fund. final notice, we are adding ‘‘teaching such progress. Another commenter This is the largest-ever single and learning environments’’ and asserted that the Department’s NPP fell investment in school reform. It is our ‘‘professional development’’ as short of the kind of clear and decisive belief that States that use these funds examples of areas in which States could guidance needed in this area. wisely will be able to make significant offer incentives and strategies. In Discussion: The Department believes inroads in addressing the problems of creating their plans, States should not that this final notice as a whole provides equitable teacher distribution. feel bound by this illustrative list; a sufficient framework for States to Changes: None. rather, they should determine which embark on a path to improving the Selection Criterion (D)(4): Improving areas will be most likely to succeed to equitable distribution of their teachers the Effectiveness of Teacher and meet their unique circumstances. and principals, while leaving States and Principal Preparation Programs Changes: We have revised criterion LEAs with sufficient discretion to (Proposed Criterion (C)(4)): (D)(3) to specify that plans submitted prepare and implement plans that make Comment: One commenter under criterion (D)(3)(1) and (ii) may sense in their specific circumstances. encouraged us to specify a link between include, but are not limited to the The Department looks forward to preparation programs and student implementation of incentives and working with grantee States to provide growth, not just student achievement, to strategies in such areas as recruitment, advice and technical assistance where account for teachers and principals compensation, teaching and learning they need it most, which could include serving in persistently low-performing environments, professional the implementation of equitable schools where their effectiveness will be development, and human resources distribution plans. determined solely based on student test practices and processes. Changes: None. scores. Comment: Multiple commenters Comment: One commenter Discussion: We agree with the expressed opposition to incentives that recommended encouraging States to commenter that teacher and principal provide salary compensation for pass legislation requiring districts and effectiveness should be measured by teachers based on the subject they teach, unions to discuss the issue of equitable student growth (and student and one supported the use of an teacher and principal distribution in achievement is an input to calculating enhanced compensation system collective bargaining negotiations. student growth); therefore both student available to all employees, which would Discussion: The Department achievement and student growth data work in tandem with the traditional encourages collaboration and should be linked to students’ teachers bargained single-salary schedule. partnerships between LEAs and teacher and principals and, in turn, this data Discussion: The Department unions to resolve issues that may arise should be linked to the programs from recognizes that, for a variety of reasons, as a result of States’ Race to the Top which those teachers and principals
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received their education credentials. We Changes: None. preparation programs, which are are revising the notice to this effect. Comment: One commenter expressed currently small (less than 20 graduates Changes: We have revised criterion concern that State assessments are not annually), and where student (D)(4)(i) by adding ‘‘and student always valid or reliable for English performance data may lag, would not be growth’’ after ‘‘student achievement.’’ language learners, making their use to included in the State’s report of the Comment: Many commenters evaluate preparation programs for effectiveness of teacher preparation encouraged the Department to require teachers of this population problematic. programs. This commenter further States to link multiple measures of Discussion: States are currently stated that institutions of higher teacher effectiveness to preparation required under the ESEA to assess education may shy away from starting programs, rather than requiring a link English language learners in a valid and new programs that are not guaranteed to only to student test scores. Some reliable manner and provide reasonable perform well, given the threshold of 20 commenters pointed out that just as accommodations including, to the graduates annually. teachers should be evaluated by extent practicable, assessments in the Discussion: We agree that restricting multiple measures, the same is true of language and form most likely to yield the reporting to those teacher and preparation programs, which contribute accurate and reliable information on principal preparation programs that to more aspects of a teacher’s what they know and can achieve in have 20 or more graduates annually will performance than just their students’ academic content areas, until such unnecessarily exclude many teacher and test scores. One commenter stated that students have achieved English principal preparation programs, teacher and principal preparation language proficiency. As States including those that provide alternative programs should also be evaluated on currently use these data in setting routes to certification. Based on the their ability to develop the capacity of academic achievement standards under comments, we also realize that it would family, school, and community the ESEA and determining targets and be a burden on States to obtain the engagement programs to improve educational needs for English language information on the many preparation student performance. Another learners in their States, we believe these programs to determine whether such commenter recommended that equal data are equally appropriate for programs annually graduate at least 20 priority be placed on teacher evaluating preparation programs under or more students. We are, therefore, preparation that recognizes the Race to the Top. revising criterion (D)(4)(i) by removing importance of teachers being Changes: None. Comment: Several commenters asked the phrase ‘‘that has twenty or more responsible for the social, creative, and graduates annually.’’ emotional development of the child as us to clarify whether the intent of this Changes: We have removed the well as academic growth. One criterion is to link data only to public phrase in criterion (D)(4)(i) that States commenter stressed that effective institutions within a given State or to report data on each credentialing preparation programs should be link teachers to out-of-State or out-of- program ‘‘that has twenty or more evaluated on measures such as the country institutions, or private graduates annually.’’ pedagogical training and clinical credentialing institutions. experiences provided to participants. Discussion: The language in criterion Comment: One commenter suggested Other commenters expressed concern (D)(4)(i) specifies that States should that we change the criterion so that that evaluating preparation programs by report the effectiveness of ‘‘each States publicly report ‘‘data’’ instead of linking student achievement data alone credentialing program in the State.’’ The ‘‘findings’’ for each credentialing would lead to a narrowing of the Department understands the phrase program, and to clarify that States need curriculum in preparation programs to ‘‘each credentialing program’’ to include only report raw data, not an analysis of focus on student test preparation. both public and private credentialing that data. Raw data could then be Discussion: We agree that many institutions. To the extent possible, we analyzed by both States and outside outcome indicators are important for encourage inter-State reporting as well. researchers. measuring the effectiveness of teacher Changes: We have clarified in Discussion: We agree that asking and principal preparation programs. criterion (D)(4)(i) that student States to report the ‘‘data’’ and not However, the Department believes that achievement and student growth data ‘‘findings’’ for each credentialing the most important indicator of the linked to the students’ teachers and program clarifies what States should quality of a preparation program is the principals should be linked to ‘‘in- report, and we are making this change. performance of the students served by State’’ programs where those teacher Changes: We have replaced the teachers and principals the program and principals were prepared for ‘‘findings’’ with ‘‘data’’ in criterion prepared. At the same time, we credentialing, and that States only need (D)(4)(i). welcome States to supplement this to publicly report data for those Comment: Several commenters asked reporting with other indicators that they credentialing programs ‘‘in the State.’’ us to explicitly state that we are believe are important. We do not agree Comment: Several commenters including programs that provide with the commenters that focusing on expressed concern regarding the alternative routes to certification in the student achievement will lead to provision that States report the data for group of credentialing programs for preparation programs narrowing their each credentialing program ‘‘that has which States should collect and report curriculum and focusing on student test twenty or more graduates annually.’’ data. preparation. We believe that publicly One commenter stated that creating an Discussion: Teacher and principal reporting effectiveness based primarily arbitrary threshold of 20 or more credentialing programs that provide on student achievement and student graduates would have the effect of only alternative routes to certification must growth will result in preparation requiring data for large teacher and be included in the group of programs reevaluating their programs to principal preparatory programs and credentialing programs on which States ensure that all teachers and principals recommended that all teacher and must report data. We do not, however, completing their programs have the principal programs be held accountable. believe it is necessary to explicitly state wide range of knowledge and skills One commenter expressed concern that this in the notice, as criterion (D)(4)(i) necessary to help raise student data on new credentialing programs, is clear that data should be collected for achievement. such as computer science teacher ‘‘each credentialing program’’ in the
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State where a State’s teachers and Selection Criterion (D)(5): Providing improvement plans for increasing leaders received their credential. Effective Support to Teachers and student achievement. Changes: None. Principals (Proposed Criterion (C)(5)): Discussion: The Department agrees Comment: Several commenters Comment: A few commenters stressed that supporting teachers and leaders suggested additional requirements be that LEAs must take the lead in through comprehensive professional applied to teacher preparation providing effective, high-quality development systems is a crucial programs, such as requiring instruction professional development. One component of education reform efforts, in certain subjects, or creating data commenter stated that this criterion which is why we included this Reform systems to track different aspects of should focus on support for Plan Criterion in the NPP. We also teacher preparation. comprehensive professional learning believe the support and professional and supports for teachers and principals opportunities provided to teachers and Discussion: We decline to specify with the understanding that this must principals should be relevant to the detailed requirements of preparation be primarily a local effort with State individual needs of teachers and programs because we believe these support. principals and should be ongoing and decisions are generally best left to the Discussion: We agree that the role of job-embedded, not short-term ‘‘one- States. We encourage States to use States under this criterion should be to shot’’ efforts that do very little to evidence, including the data States will support LEAs in providing effective improve the quality of teaching. gather over time from the systems they professional development to their We appreciate the suggestions we put into place for criterion (D)(4)(i), to teachers and principals, and we are received for examples of the types of continuously improve the quality of revising the criterion to clarify this. professional development activities that their teacher and principal preparation Changes: Criterion (D)(5)(i) has been are most effective, and we have chosen programs. revised to clarify that the States’ plans to include several of these in this notice Changes: None. are for participating LEAs (as defined in (see criterion D(5)). It is the Comment: A few commenters this notice) to provide effective, data- Department’s expectation, however, that recommended that we require States to informed support to teachers and professional development plans will be report information regarding teacher principals. developed in response to data and to and principal effectiveness directly to Comment: Many commenters specific staff needs, rather than around the preparation programs. applauded the Department’s inclusion the illustrative examples. Discussion: In order to meet this of this criterion, and some suggested it Changes: We have re-organized and criterion, States must publicly report the is one of the most important Race to the revised criterion (D)(5) by inserting a data for each credentialing program. Top criteria. One commenter stated that new paragraph (i) and clarifying that the Preparation programs will therefore teachers will be more or less effective in professional development, coaching, have access to these public reports. meeting the goal of improving student induction, and common planning and Changes: None. achievement to the degree that they collaboration time provided to teachers Comment: One commenter requested have the necessary supports and and principals should, where clarification on which institution data resources available to them in their appropriate, be ‘‘ongoing and job- would be linked to in the event that a workplace. One commenter suggested embedded.’’ We also have added that teacher or principal held multiple that professional development should such supports might focus, for example, credentials, each from a different be utilized not simply to provide new on gathering, analyzing, and using data; institution. information but to support teachers in designing instructional strategies for becoming more effective. One improvement; differentiating Discussion: If a teacher or principal commenter stated there should be more instruction; creating school holds multiple credentials from emphasis on expanding the pool of environments supportive of data- different credentialing programs, States experienced school leaders and teachers informed decisions; designing need only link their data to the available to lead reform efforts. In that instruction to meet the specific needs of credentialing institutions that issued the respect, some commenters stated that high-need students (as defined in this credential that the teacher or principal the States need more guidance in notice); and aligning systems and is using for the teacher or principal’s developing comprehensive professional removing barriers to effective current assignment. States also would development systems. The commenters implementation of practices designed to have the option to link such teachers or argued that while professional improve student learning outcomes. principals to each institution from development and common planning and Comment: Several commenters which they received a credential. collaboration time are helpful, such suggested that States should include Changes: None. supports in and of themselves are not teacher induction as a part of the high- Comment: One commenter expressed likely to be sufficient in bringing about quality plan they submit under criterion concern that it is unrealistic for States significant changes needed to meet (D)(5). One commenter stated that new to achieve the required data linkages in reform goals. Several commenters teachers require a strong induction a reasonable period of time. suggested that in developing program, or at a minimum, support and Discussion: We recognize that many professional development systems assistance from accomplished teachers States may not currently have data States should require teachers and to help them develop the skills needed systems in place to collect the required administrators to collaborate with each to construct high-quality assessments data, but we believe that the four-year other with the goal of individualizing and effectively diagnose student period in which States may use Race to support tailored to fit specific teacher responses. Another commenter pointed the Top funds should be sufficient for needs for meeting reform goals. They out that studies show induction them to implement their plans in this recommended that such individualized programs and other intensive supports area. In responding to this criterion, as support should be provided for both for beginning teachers improve teacher with others, States should propose plans teachers and principals through retention, increase student achievement, that build on and are informed by the implementation of ongoing, job- and provide a significant return on assets the State currently has. embedded professional learning investment. One commenter suggested Changes: None. opportunities aligned with district requiring States to include in their plans
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measures that take into account the professional development for STEM does not, however, preclude States and unique professional development needs teachers is imperative. One commenter LEAs from providing more specific of new teachers and leaders, especially suggested that States provide high- supports based on student data and the given the disproportionate number of quality teacher education programs, individual needs of teachers and leaders new teachers and leaders working in including immersion experiences both to improve the effectiveness of high-need schools. Other commenters in the U.S. and abroad, for foreign instruction for improving student recommended that new teachers partner language teachers. A few commenters outcomes. with effective and experienced teachers argued for the provision of professional Changes: None. as an effective approach for addressing development designed specifically to Comment: One commenter suggested the unique needs of new teachers. One meet the needs of teachers working with integrating family, school, and commenter recommended including diverse populations, including students community engagement into structured mentoring from principals with disabilities, gifted and talented professional development opportunities. and teachers who have demonstrated students, Native Americans, and English Another commenter suggested that such success in turning around struggling language learners. opportunities should include training schools. Discussion: All teachers, including parents in partnership with Discussion: We agree that induction teachers working with the students in professionals. programs and coaching by the areas and subjects mentioned by the Discussion: The Department accomplished teachers and principals commenters, should have access to recognizes the need for family and can be important and effective strategies high-quality professional development community engagement in schools. for supporting novice teachers and and support. As LEAs and States While several examples of professional principals upon their entering the collaborate to develop their plans for development opportunities in this area profession. We are revising the criterion providing support to teachers and have been included, LEAs and schools to clarify that States’ plans in response principals, we expect they will identify are encouraged to utilize data to inform to this criterion should provide for the various types of professional program development to meet local coaching and induction programs as development and other supports needs. As noted previously, States may supports for teachers and principals. necessary for different teachers and choose to include in their plans Changes: We have revised criterion principals. For this reason, we do not professional development opportunities (D)(5)(i) to clarify that plans should believe it is necessary to reference and support for individuals other than include providing effective, data- specific subject areas or student teachers and leaders, including parents. informed ‘‘coaching’’ and ‘‘induction.’’ populations in criterion (D)(5). In Changes: None. Comment: A few commenters stated addition, the Department clarified Comment: Several commenters that, in addition to providing positive language in the definition of alternative endorsed the Department’s goal to conditions within which teachers can be routes to certification to note that provide support for teachers and successful, there are also barriers to ‘‘standard features’’ of such a program principals but contended that success that should be eliminated. The would include ‘‘high-quality instruction professional development opportunities greatest barrier cited is time—that in pedagogy and in addressing the needs and other support services should also teachers are not given sufficient time to of all students in the classroom be provided for individuals working collaborate, plan, or review data. Some including English language learners and with students outside of the regular commenters suggested that States students with disabilities.’’ school day. Such individuals might should be required to determine Changes: None. include youth development whether or not school and classroom Comment: Several commenters professionals, expanded learning climates were conducive to teaching suggested including opportunities for providers, and those working in schools and learning, and thus supportive of improving professional learning for for over-age and under-credited youth. teachers’ efforts. One commenter support personnel. Commenters pointed out that students contended that student learning is Discussion: All adults in a school, should have access to engaging learning linked to educators’ perceptions of the including support personnel, play an opportunities throughout the continuum culture and context of their schools and important role in creating a school of their learning day. They argued that a better understanding by administrators culture of high expectations and share individuals from other agencies or of these perceptions can help responsibility for student success. While sources outside the school working with administrators address these barriers to the focus of States’ plans in response to students in these programs need success. criterion (D)(5) should be on support for professional support and training to Discussion: The Department agrees teachers and principals, States may enable them to align their services with that supporting teachers and principals choose to include in their plans school goals to improve student includes ensuring that school professional development opportunities outcomes. environments are positive and and support for individuals other than Discussion: The Department supports conducive to teaching and learning, and teachers and leaders, such as support the coordination of services and that barriers to effectiveness are personnel. opportunities for high-need students minimized. Changes: None. across schools, State agencies, and Changes: In the list of supports that Comment: One commenter suggested community partners. For this reason, LEAs might provide to teachers and that professional development aimed at the Department has included in this principals in criterion (D)(5)(i), we have improving teacher and principal quality notice an invitational priority added ‘‘creating school environments should include investing in technical specifically addressing the coordination supportive of data-informed decisions’’ assistance for implementation of the of services across various agencies and and ‘‘aligning systems and removing Positive Behavior Support model. community partners. (See priority 5: barriers to effective implementation of Discussion: The Department cannot Invitational priority—P–20 practices designed to improve student assume all schools need to implement a Coordination, Vertical and Horizontal learning outcomes.’’ particular reform model. Inclusion of Alignment). If a State elects to address Comment: Two commenters insisted examples of different types of this invitational priority in its that the provision of content-rich professional development in this notice, application, it could choose to include
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in its plan any professional from proposed criterion (C)(5). One the Top funds to accomplish their plans development or support activities that commenter noted that while the and meet their targets. It is up to the are needed to align services to improve Department’s call for providing effective States to determine how much funding student outcomes. Again, as stated support for teachers and principals is to designate for providing support to previously, States may also choose to appreciated, the language in the final teachers and principals under criterion include in their plans professional notice should place a greater emphasis (D)(5). In response to the development opportunities and support on vital supports rather than on the recommendation that States be for individuals other than teachers and utilization of rapid-time data to inform penalized for reducing professional leaders. it. A few commenters agreed that development funding, we note that, Changes: None. student data provide a useful tool for under criterion (F)(1), States will be Comment: Several commenters guiding instruction but argued that an evaluated based on the extent to which encouraged the Department to require undue emphasis on rapid-time student they have made education funding a States to provide guidance to LEAs in data will have a negative impact on priority. We do not believe it is developing evaluation plans that are overall data quality for improving necessary to include a criterion specific designed to examine the impact of outcomes. They stated that student data to funding for professional professional development opportunities. alone is not sufficient for evaluating and development. One commenter stated that such improving teaching effectiveness, and Changes: None. evaluation plans should be designed to argued that a variety of evaluation Comment: None. provide data on the impact of techniques are needed to capture the Discussion: We are revising some of professional development on breadth of effective teaching and the evidence and performance measures leadership, instruction, and student professional practice. They suggested to be consistent with the changes made achievement. One commenter argued that teacher support is better informed to criterion (D) in this notice. In some that States and LEAs need to engage in through the incorporation of portfolio instances we also are revising the inquiry, analysis, and reflection about assessments, review of lesson plans, evidence and performance measures to the results of professional development self-assessments, teaching artifacts, provide greater clarity. as a means for improving its quality. classroom observation, and feedback on Changes: Appendix A, Evidence and The commenter further stated that teaching practice. Another commenter Performance Measures, criterion (D) comprehensive evaluation plans would noted that utilization of rapid-time Great Teachers and Leaders, has been capture data to inform leadership student data is far too limited as a revised to reflect the changes made to actions for allocating resources as well concept and practice, and argued that criterion (D) and to provide greater as for aligning staff, policies, and the emphasis should be on building clarity. structures to improve student learning comprehensive professional learning E. Turning Around the Lowest- and teacher effectiveness outcomes. systems that can be integrated into Achieving Schools Discussion: We agree that the building the capacity of all schools to supports provided to teachers and serve children well. Definitions: increased learning time, principals should be continuously Discussion: The Department is persistently lowest-achieving schools. measured to improve the effectiveness persuaded by the concerns expressed by Comments regarding the preceding of those supports. We also agree that the the commenters regarding using rapid- definitions are addressed, as purpose of this measurement and time student data to inform and guide appropriate, below. improvement is to ensure that the the support provided to teachers and Introduction supports result in improved student principals. Accordingly, we are achievement. While that was our intent removing this language from criterion A central purpose of ARRA funds is in the NPP, we believe that we should (D)(5). to increase the academic achievement of more clearly state that intent in this Changes: The phrase ‘‘use rapid-time students in struggling schools. As a notice. Accordingly, we are revising (as defined in this notice) student data result, the Notices of Proposed criterion (D)(5)(ii) to that effect. We to inform and guide the support Requirements (NPRs) regarding the State believe that the resulting language provided to teachers and principals’’ Fiscal Stabilization Fund Phase II and sufficiently addresses the commenters’ has been removed from criterion (D)(5). the School Improvement Grants suggestion about evaluation plans. The Comment: One commenter suggested programs, as well as the Race to the Top Department expects that, through the revising the notice to provide funds for NPP, each included requirements process of working with LEAs, States professional learning to help educators related to struggling schools. The most will determine what guidance LEAs improve the knowledge and skills that explicit requirements were included in may need to help them continuously will enable them to do their jobs well. the School Improvement Grants NPR measure and improve the supports they Another commenter expressed concern that was published in the Federal provide to teachers and principals. that there are not enough funds to Register on August 26, 2009 (74 FR Changes: We have reorganized and design and implement the professional 43101), in which the Department revised criterion (D)(5) by adding development required to improve proposed four rigorous school criterion (D)(5)(ii) and clarifying that the teaching and learning. One commenter intervention models—turnaround, measurement, evaluation, and recommended specifying that States that restart, school closure, and improvement of the effectiveness of the have reduced funding for professional transformation—that an LEA seeking supports provided to teachers and development activities should be School Improvement Grant funds would principals is conducted in order to penalized in their applications. The implement in the lowest-achieving Title improve student achievement. commenter also recommended that Race I schools in improvement, corrective Comment: Several commenters to the Top funding should be used to action, or restructuring identified by expressed concern with using rapid- ensure that meaningful standards-based each State and could also implement in time student data to inform and guide professional development activities are secondary schools that are eligible for, the support provided to teachers and provided. but do not receive, Title I funds. principals. Many of these commenters Discussion: States must include a Commenters on each notice recommended removing this language description of how they will use Race to recommended that the Department
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make the identity of, and requirements Comment: Several commenters commenters expressed concerns about for, struggling schools consistent among expressed support for criterion (E)(1) the processes, procedures, and funding all three programs. We agree with these (proposed criterion (D)(1)), which will for any State intervention in schools and comments and, in response, have examine the extent to which a State has LEAs. Commenters also claimed that revised the four school intervention the legal, statutory, or regulatory State intervention in schools and LEAs models and are integrating them into the authority to intervene directly in its would violate State constitutions, that criteria, definitions, and requirements persistently lowest-achieving schools most States did not have the capacity to for all three programs. In addition, we (as defined in this notice) and in LEAs support effective intervention, and that have developed a definition of identified for improvement or corrective many such efforts in the past had ended persistently lowest-achieving schools to action under the ESEA. Two of these in failure. substitute for ‘‘schools in the lowest five commenters proposed that the Discussion: The purpose of criterion percent’’ (Stabilization Fund) and Department require additional (E)(1) is to reward States for, and persistently lowest-performing schools information about a State’s authority to encourage them to have, the authority to (Race to the Top) for use in all three intervene, including examples of when intervene, if necessary, in their programs. and how the authority had been used persistently lowest-achieving schools Because both the Stabilization Fund and any available evaluation of State and LEAs that are in improvement or and Race to the Top notices of final plans and processes for using the corrective action status. The Department requirements are being published prior authority. Another commenter believes that States that have such to the final School Improvement Grants recommended that States receive extra authority are in a stronger position to notice, we have published the points for aggressive use of any hold LEAs and schools accountable for requirements for the four models in the authority to intervene in low-performing implementing effective school final notice for the Stabilization Fund, schools and LEAs. intervention strategies, particularly in are including them in Appendix C to Discussion: Criterion (E)(1) is cases where LEAs or schools continue to this final notice, and will incorporate intended to reward States based on the fail their students year after year. them into the final School Improvement extent to which they have the legal Criterion (E)(1) will give States credit Grants notice when it is issued. In order authority to intervene directly in their only for having the authority to to clarify and fully explain the persistently lowest-achieving schools, as intervene, and not for actual definition of persistently lowest- well as in LEAs identified for intervention. This criterion is not achieving schools and the changes that improvement or corrective action. The intended to encourage such we made to the four models, we also are Department believes that such authority interventions by States; rather, it including in this notice the comments to intervene is important for a State’s recognizes that, in cases where LEAs are and responses related to the definition ability to hold LEAs accountable for unwilling or unable to successfully and those models from the School turning around their persistently lowest- implement the school intervention Improvement Grants NPR. In the achieving schools. However, the models required by section (E)(2) of this Department is not seeking to encourage notice, State intervention may be both following sections, we first discuss the direct State intervention per se; the appropriate and necessary. However, we comments we received on struggling language of criterion (E)(2) (proposed also believe that as States build State schools in reply to the Race to the Top criterion (D)(3)) makes clear that the and local capacity to turn around their NPP and our responses. We then discuss primary role of a State with regard to its persistently lowest-achieving schools, the comments we received related to the persistently lowest-achieving schools is they should have fewer and fewer definition and the four intervention to ‘‘identify’’ and ‘‘support its LEAs in reasons for direct intervention. models as proposed in the School turning around these schools by Changes: None. Improvement Grants NPR and our implementing one of the four school Selection Criterion (E)(2): Turning responses to those comments. intervention models.’’ For this reason, Around the Lowest-Achieving Schools Selection Criterion (E)(1): Intervening the Department declines to require (Proposed Selection Criterion (D)(3)): in the Lowest-Achieving Schools and States to provide more information Comment: None. LEAs (Proposed Selection Criterion about their implementation of this Discussion: As discussed in the (D)(1)): authority or to award ‘‘extra points’’ to introduction to this section, we are Comment: None. States that have demonstrated replacing the models described in Discussion: The Department is ‘‘aggressive’’ use of such authority. proposed criterion (D)(3) of the NPP changing the headings in this section to Changes: None. with the four models that have been describe ‘‘lowest-achieving schools’’ Comment: Many commenters developed in response to public instead of ‘‘lowest-performing schools’’ appeared to misunderstand the impact comments across all three notices. The to be consistent with the revised of criterion (E)(1) that a State’s four school intervention models are (1) definition of persistently lowest- application for a Race to the Top grant a turnaround model, which would achieving schools, which is based describe the extent to which it has the involve, among other actions, replacing primarily on achievement scores and legal, statutory, or regulatory authority the principal and rehiring no more than not on broader measures of school to intervene directly in its lowest- 50 percent of the school’s staff, adopting performance, as suggested by the performing schools and in LEAs a new governance structure, and headings in the NPP. We also are identified for improvement or corrective implementing a research-based and replacing the phrase ‘‘struggling action. For example, some of these vertically aligned instructional program; schools’’ with ‘‘persistently lowest- commenters appeared to believe that the (2) a restart model, in which an LEA achieving schools’’ to avoid confusion criterion itself would provide States the would convert a school or close and on this subject. authority to intervene in their lowest- reopen a school under the management Changes: The Department has performing schools and LEAs; these of a charter school operator, a charter changed the terms ‘‘lowest-performing commenters objected to such authority management organization (CMO), or an schools’’ and ‘‘struggling schools’’ to on the grounds that school improvement educational management organization ‘‘persistently lowest-achieving schools’’ must be locally based and not imposed (EMO) that has been selected through a throughout this notice. by the Federal Government. Other rigorous review process; (3) a school
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closure model, in which an LEA would school intervention strategies that were other areas that may need to overcome close the school and enroll the students achieving positive results. Several a variety of resource limitations. who attended the school in other, commenters identified other reform Further, as noted in Appendix C, if a higher-achieving schools in the LEA; strategies that they believe should be school identified as persistently lowest- and (4) a transformation model, which included in the school intervention achieving has implemented an would address four specific areas options under (E)(2), including common intervention or part of an intervention critical to transforming a persistently planning time for teachers, career in the last two years that meets the lowest-achieving school. Each of these pathways or career cluster programs, requirements of the turnaround, restart, models is described in detail in inquiry-based and applied learning or transformation models, the school Appendix C of this notice. strategies, such as service learning, may continue or complete its work. Changes: We have removed the summer camp, character education, Changes: Criterion (E)(2) replaces the description of the school intervention magnet schools, improving school school intervention models proposed in models in criterion (E)(2), which now library programs, and the use of criterion (D)(3) of the NPP with the four provides for a State to have a high- technology as part of school models adopted from the School quality plan and ambitious yet intervention models. Other Improvement Grants program and achievable annual targets for (1) recommended strategies included, for described in Appendix C of this notice. identifying its persistently lowest- example, the involvement of teachers in The Role of States and LEAs in School achieving schools (as defined in this school-based decision-making, district Intervention notice) and, at the State’s discretion, any and union leadership support for school non-Title I eligible secondary schools staff, providing additional trained staff Comment: One commenter that would be considered persistently to support classroom needs, smaller recommended that the Race to the Top application require States to explain lowest-achieving schools if they were class sizes, the promotion of a safe and how they will meet the existing ESEA eligible to receive Title I funds, and (2) orderly school climate, and a focus on requirements regarding schools supporting its LEAs in turning around students’ social, emotional, and health identified for improvement. Other these schools by implementing one of needs. the four school intervention models commenters called for States and LEAs Discussion: The Department adopted from the School Improvement to propose their own intervention plans recognizes that there are other reform Grants program: a turnaround model, on the basis of evidence from research models and interventions not identified restart model, school closure, or and evaluation, including ‘‘charter-like’’ transformation model (provided that an in the NPP that can be successful in options, or to build on current LEA with more than nine persistently turning around the persistently lowest- turnaround efforts. Similarly, another lowest-achieving schools may not use achieving schools. We also understand commenter recommended requiring the transformation model for more than that no single reform model will be States to explain how they will combine 50 percent of its schools). These models effective in every State or every district. governance changes with transformation are described in detail in Appendix C of However, the school intervention models to improve teaching and this notice. models in criterion (E)(2) focus on learning. One commenter called for Comment: Several commenters dramatic change, including significant LEAs to propose their own school supported the strategies in criterion changes in leadership and staffing, intervention strategies to their States, (E)(2) for turning around the lowest- because they are targeted to the nation’s which could mandate alternatives if the achieving schools, but many persistently lowest-achieving schools, LEA proposals were not rigorous commenters objected to these strategies which in most cases have not responded enough. Two commenters, however, as too prescriptive, overly focused on to multiple earlier school improvement called for States, not LEAs, to mandate governance issues, poorly grounded in and turnaround efforts. Research required school interventions based on research, and not truly innovative. indicates that fundamental, their own analyses of those schools’ low Several commenters, in particular, comprehensive changes in leadership, performance. focused on what they described as the staffing, and governance hold the Discussion: States and LEAs have had punitive nature of the proposed school greatest promise for bringing about the considerable flexibility in implementing intervention models due to the improvements in school structure, the school improvement provisions emphasis on leadership and staff climate, and culture that are required to under section 1116 of the ESEA; replacement, charter school break the cycle of chronic educational unfortunately there is little evidence of conversions, turning over operations to failure. In addition, the commenters’ success, as the number of schools in the outside management, and closing focus on staffing and governance issues final stage of improvement— schools. Others believed that these led them to overlook the significant restructuring—has nearly tripled over strategies would prove ‘‘unrealistic’’ in flexibility provided to adopt specific the past few years, to about 5,000 many areas, with one commenter reforms such as teacher involvement in schools. The emphasis of the ARRA on claiming that they ‘‘simply won’t work decision-making and smaller class sizes. turning around struggling schools in our rural/frontier State.’’ A few A key purpose of changes in leadership reflects, in part, the response of the commenters observed that limiting and governance is to promote greater Congress to this limited success of ESEA school intervention options as proposed school-based flexibility over things that school improvement measures in in criterion (E)(2) appeared to be matter, such as hiring effective teachers, turning around chronically low- contrary to the Secretary’s stated increasing time for both instruction and performing schools. States and LEAs are commitment to be ‘‘tight on goals and staff collaboration, and control over expected to use other ARRA funds, loose on the means.’’ In response to budget decisions. The Department including the State Fiscal Stabilization such concerns, many of these recognizes that implementing these Fund, Title I Grants to Local commenters called for greater flexibility turnaround models will be challenging Educational Agencies, and Title I to adopt other school intervention for LEAs, and expects State plans to School Improvement Grants, to carry models, including those that they include technical assistance and other out the school improvement claimed were grounded in research, as support, including support for requirements of the ESEA. Under the well as the option of continuing existing successful turnarounds in rural and Race to the Top program, the
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Department is asking States to raise the assistance to LEAs to increase their with generally high performance that bar for school improvement by agreeing capacity to support school-level reform, serve significant numbers of students to undertake, in addition to existing and four commenters recommended that who are not performing well. Another ESEA school improvement activities, the final notice require States to specify commenter stated that linking the dramatic changes and improvement in the LEA role in, and capacity to manage, number of schools that a State must turn their persistently lowest-achieving school interventions that will be around to the number of schools schools, drawing from a set of models required under their Race to the Top identified for improvement under the that the Department believes holds the plans. ESEA would penalize States with more greatest promise for breaking the cycle Discussion: We agree that ambitious AYP criteria. Finally, one of chronic educational failure in these participating LEAs will play a leading commenter asked how schools would schools. States and LEAs are not role in implementing school exit the ‘‘bottom five percent status’’ required to use these models—they are intervention models, and that States described in the NPP. part of the criteria for the Race to the should help build LEA capacity to fulfill Discussion: The Department agrees Top competition, not eligibility this role effectively. In criterion that the language in the NPP, in requirements—but States that agree to (A)(2)(i)(b), States will be evaluated combination with the proposed support the interventions required by based upon their plans to support definition of persistently lowest- criterion (E)(2) will earn points that will participating LEAs (as defined in this performing schools, was unclear and strengthen their overall Race to the Top notice) in successfully implementing potentially created confusion about how application and increase their chances the State’s Race to the Top plans, States would identify schools for the of winning a Race to the Top grant. In through such activities as identifying interventions described in criterion general, the Department anticipates that promising practices, evaluating these (E)(2). We also recognize the concerns of LEAs will select the appropriate school practices’ effectiveness, ceasing commenters that the criteria in the NPP intervention models and that States will ineffective practices, widely could lead some States to identify too support LEAs in implementing these disseminating and replicating the few schools for intervention efforts. In models. However, criterion (E)(1), effective practices statewide, holding response, the Department has (1) which will assess a State’s authority to participating LEAs (as defined in this modified the definition of the term intervene directly in its persistently notice) accountable for progress and persistently lowest-achieving schools lowest-achieving schools and LEAs that performance, and, if necessary, and (2) modified criterion (E)(2) to give are identified for improvement or intervening directly to effectively States discretion to identify for corrective action under the ESEA, implement school intervention models. intervention any non-Title I eligible reflects the Department’s recognition The Department declines to specify the public secondary school that would be that some States may wish, or in some LEA role in the school intervention considered a persistently lowest- States it may be necessary, to take models, as this role will vary based on achieving school (as defined in this additional actions. local capacity and circumstances. We notice) if it were eligible to receive Title This final notice, like the NPP, does want to give States and LEAs flexibility I funds. The Department believes that include criteria that allow States to earn to define the LEA role both in State these changes will ensure that States points for their own existing or planned reform plans and in the MOUs identify a sufficient number of schools efforts to support effective school completed by participating LEAs (as to target for intervention efforts and that interventions. Criterion (F)(3) (proposed defined in this notice). such efforts are not limited by the Title criterion (E)(1)(iii)) provides that a State Changes: None. I status of the State’s lowest-achieving will receive points if the State, through Number of School Interventions schools. As for how schools would exit law, regulation, or policy, has created the persistently lowest-achieving other conditions supporting education Comment: Several commenters schools (as defined in this notice) reform and innovation that are not requested that the Department clarify category, we note that the purpose of addressed under other State Reform how a State determines the schools that this category, consistent with criterion Conditions Criteria and that have it must target for intervention under (E)(2), is to identify schools in which increased student achievement or section (E)(2). Another commenter LEAs will implement one of four school graduation rates, narrowed achievement expressed concern about the potentially intervention models. For this purpose, a gaps or resulted in other important low number of schools that would be school in which one of these models has outcomes. subject to school intervention options been implemented would no longer be Changes: Criterion (F)(3) has been under the proposed requirements; in subject to intervention, but may remain revised to measure the extent to which particular, this commenter worried that on a State’s list of persistently lowest- a State, in addition to information the combination of required Title I achieving schools as long as it meets provided under other State Reform status and varying rates of State one of the criteria in the definition of Conditions Criteria, has created, through identification of schools for persistently lowest-achieving schools. law, regulation, or policy, other improvement under section 1116 of the Changes: We have revised the conditions favorable to education ESEA could significantly limit the definition of persistently lowest- reform or innovation that have application of Race to the Top school achieving schools to mean, as increased student achievement or intervention requirements, particularly determined by the State: (i) Any Title I graduation rates, narrowed achievement to the lowest-performing high schools. school in improvement, corrective gaps, or resulted in other important The commenter suggested replacing the action, or restructuring that (a) Is among outcomes. proposed ‘‘bottom five percent’’ the lowest-achieving five percent of approach with a requirement to turn Title I schools in improvement, LEA Capacity around the lowest-performing one corrective action, or restructuring or the Comment: Several commenters percent of all schools annually, with the lowest-achieving five Title I schools in recommended an increased focus on the one-percent cap applied separately to improvement, corrective action, or LEA role in school interventions. Three elementary/middle schools and high restructuring in the State, whichever commenters observed that States should schools. This commenter added that number of schools is greater; or (b) Is a be required to provide technical interventions should include schools high school that has had a graduation
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rate as defined in 34 CFR 200.19(b) that ‘‘silver bullet’’ for low-achieving or that new leadership should have a is less than 60 percent over a number of schools, but believes each may help to ‘‘documented likelihood’’ of years; and (ii) Any secondary school create the conditions of autonomy and successfully raising student that is eligible for, but does not receive, flexibility that are associated with achievement. One commenter Title I funds that (a) Is among the successful turnaround efforts. recommended modifying the first three lowest-achieving five percent of Changes: None. school intervention models— secondary schools or the lowest- Replacing Leadership and Staff turnaround, restart, and school achieving five secondary schools in the closure—to include provisions for State that are eligible for, but do not Comment: Many commenters opposed consensual placement (i.e., with the receive, Title I funds, whichever replacing school leadership and staff as agreement of the hiring school) of staff number of schools is greater; or (b) Is a part of the school intervention models that lose their jobs due to high school that has had a graduation required by proposed criterion (D)(3) implementation of these options or, in rate as defined in 34 CFR 200.19(b) that and now described in detail in the absence of such consensual is less than 60 percent over a number of Appendix C, with some commenters placement, release from employment. claiming that research shows that staff years. Discussion: The Secretary To identify the lowest-achieving replacement is an ineffective reform strategy, others stating that such understands that replacing leadership schools, a State must take into account and staff is one of the most difficult both (i) The academic achievement of strategies are not really an option in many communities that already face aspects of the school intervention the ‘‘all students’’ group in a school in models required by criterion (E)(2). terms of proficiency on the assessments teacher and principal shortages, and a However, he also believes that in our under section 1111(b)(3) of the ESEA in few commenters arguing that fear of lowest-achieving schools, many of reading/language arts and mathematics what might be perceived as arbitrary which have failed to improve despite combined; and (ii) The school’s lack of dismissals associated with school repeated earlier interventions, dramatic progress on those assessments over a intervention models could create a changes in leadership and staffing can number of years in the ‘‘all students’’ disincentive for talented teachers and be the key to creating the new climate group. principals to work in struggling schools. Another commenter, however, generally and culture needed to break the cycle of Governance Issues supported the emphasis on changing educational failure. On the other hand, Comment: One commenter did not leadership, citing research showing that while we believe the required agree with the perceived emphasis in principals are the second most intervention models leave room to the NPP on existing school governance important factor contributing to student accommodate many of the flexibilities as the cause of school failure, or that achievement, after classroom requested by these commenters, the four there is research or other evidence that instruction. A number of other school intervention models adopted changing lines of authority or reporting commenters recommended changes to from the School Improvement Grants will help turn around a low-performing the staff and leadership replacement program and described in detail in school. This commenter added that the requirements in these models, including Appendix C specifically include several Secretary has indicated that he supports (1) giving the new leadership under the of the changes suggested by partnerships between school boards and turnaround model greater flexibility to commenters. For example, we have mayors, as opposed, for example, to a make its own firing and hiring decisions clarified that by ‘‘new leadership’’ mayor taking direct control of a school instead of simply requiring the under the turnaround model, we mean district. Another commenter suggested replacement of a ‘‘majority’’ of staff; (2) the principal of the school, and that by an additional governance-based requiring all staff to reapply for their requiring ‘‘a majority of new staff’’ in a intervention option, for a school that positions as long as the principal has turnaround school we mean that no already has undergone unsuccessful full authority to hire either former staff more than 50 percent of existing staff restructuring, involving placement of or staff from outside the school; (3) may be rehired. Also, the turnaround the school under the direct control of retaining leadership and staff if they model adopted from the School the district’s superintendent or support the rest of the turnaround plan; Improvement Grants program now must establishing a ‘‘professional learning (4) retaining at least 50 percent of include giving the new principal community’’ in partnership with current staff who reapply and meet all significant operating flexibility in areas another school district. of the requirements of the redesigned such as staffing, school calendar and Discussion: Changing school school; and (5) focusing on staff scheduling, and budgeting. In addition, governance can take a variety of forms, qualifications and putting in place in determining which staff to rehire, and different solutions may be effective staff rather than on a particular LEAs must use locally adopted appropriate to different situations. One target level of replacements. One competencies to measure the possible option consistent with this commenter requested clarification of the effectiveness of staff who can work final notice is conversion to a charter terms ‘‘new leadership’’ and ‘‘a majority within the turnaround environment to school or management by a CMO or of new staff.’’ A few commenters sought meet the needs of students. Also, a EMO. Another possibility, suggested by greater flexibility for principals under principal hired in the past two years as one commenter, would be for a the school intervention models, part of a planned intervention would superintendent or someone reporting including the option of retaining have time to continue or complete the directly to the superintendent to oversee principals who have had a positive intervention as part of one of the four turnaround schools. Alternatively, a impact on student outcomes or were models. Moreover, there is nothing in mayor might, in consultation with the recently hired and giving current the models described in Appendix C to local school board, create an office principals a minimum of two years to this notice that would prevent a State or charged with supervising turnaround improve before being replaced. Other LEA from requiring replacement efforts, or a State might directly commenters stated that replacement principals or other school leaders to intervene with a takeover. The principals should be required to have a have a record of success in previous Department understands and agrees that record of significantly increasing assignments. As for consensual none of these governance changes is a student achievement at similar schools, placement policies, such issues are best
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resolved at the State and local level in Understanding or other binding schools (as defined in this notice). the context of existing collective agreements completed by participating Additionally, restart schools based on bargaining agreements. Finally, while LEAs (as defined in this notice) under the charter school model are only one of the implementation or potential criterion (A)(1)(ii)(c). In addition, the four school intervention models implementation of dramatic school criterion (A)(2)(ii)(a) calls for States to required in section (E)(2) of this notice. intervention models could encourage demonstrate support for their Race to We are therefore moving proposed some effective principals and teachers the Top plans by obtaining statements criterion (D)(2) to (F)(2) in this notice to to leave or not seek employment in the or actions of support from, among other help clarify that a State’s support for lowest-achieving schools, the Race to stakeholders, State teachers’ unions or increasing the number of high- the Top and other Federal programs also statewide teacher associations. As stated performing charter schools is only part are creating incentives and providing elsewhere in this notice, the concerns of its overall Race to the Top plan, resources that can be used to reward raised by commenters are not including its efforts to turn around its effective teachers and principals and insurmountable, and the Secretary lowest-achieving schools. Also, we improve strategies for recruitment, believes that LEAs and unions can work believe that the new criterion (F)(2) will retention, and professional together to make the changes required to better communicate the emphasis not development. Moreover, the flexibilities turn around our persistently lowest- just on increasing the number of charter for improving teaching and learning and achieving schools. schools, but on increasing the number of the focus on school improvement that Changes: None. high-performing charter schools (as are created by the intervention models The Role of Charter Schools defined in this notice). Finally, new in criterion (E)(2) are equally likely to criterion (F)(2)(v) will give States credit draw talented new leaders and staff to Comment: Several commenters for the extent to which they enable schools implementing these models. recommended that State school LEAs to operate innovative, autonomous Changes: We have replaced the intervention plans include the use of the public schools other than charter interventions outlined in proposed charter school model both to improve schools. criterion (D)(3) (new (E)(2)) with the the persistently lowest-achieving Changes: Proposed criterion (D)(2), four school intervention models schools (as defined in this notice) and Increasing the Supply of High-Quality adopted from the School Improvement to create a large number of new high- Charter Schools, has been renamed Grants program and described in detail quality charter schools to better serve Ensuring Successful Conditions for in Appendix C of this final notice. students currently attending such High-Performing Charter Schools and schools. However, two commenters said Other Innovative Schools and moved to Impact of Collective Bargaining that the criteria in proposed section (D) (F)(2) in this final notice. In addition, Agreements on Intervention Options for turning around the persistently new criterion (F)(2)(v) will give States Comment: Several commenters stated lowest-achieving schools (as defined in credit for the extent to which they that because the school intervention this notice) relied too heavily on charter enable LEAs to operate innovative, models referenced in criterion (E)(2) schools; one of them noted that charters autonomous public schools other than include provisions that would affect originally were intended as charter schools. We have added a collective bargaining agreements related ‘‘experimental incubators for education definition of innovative, autonomous to staffing, time, evaluation, and change’’ and not as the ‘‘parallel public schools to give greater clarity to compensation, such options would have educational system’’ that they claimed new criterion (F)(2)(v). to be locally negotiated by the collective would be promoted by the NPP. bargaining representative. One Discussion: We believe strongly that Charter School Conversions commenter also noted that the hiring high-performing charter schools can be Comment: Several commenters and firing of teachers and principals especially valuable in communities recommended modifying the proposed required by the proposed intervention where chronically low-performing charter school restart option to options currently are limited by State traditional public schools have failed to emphasize the need to first close a law. Another commenter added that improve after years of conventional school and then re-open it as a charter interventions should be subject to due efforts to turn them around. In such school, rather than directly convert an process. cases, high-performing charter schools, existing low-performing school into a Discussion: The Department whether created through the conversion charter school. Two other commenters recognizes that State and local Race to of a traditional public school enrolling urged the Department to require the Top plans, including school the same students or by establishing a intervention planning to be done while intervention models implemented as new school that provides an alternative students still attend their current part of these plans, may have an impact to the regular public schools, can offer school. These commenters stressed the on issues covered by collective promising and proven options for importance of ensuring that charter bargaining agreements, and agrees that breaking the cycle of educational schools ‘‘start fresh with the student such issues would have to be negotiated failure. At the same time, we body and fully implement their own within the context of these agreements. acknowledge that the placement of the approach.’’ One commenter emphasized The Department urges LEAs to work proposed charter schools criterion (D)(2) that the selection of the charter school with teacher unions and teacher in the struggling schools section in the conversion option should result in membership associations to resolve NPP potentially gave the impression ‘‘schools of choice’’—schools chosen by such issues, as well as other legal and that the NPP was emphasizing charter both students who enroll and the staff regulatory barriers to successful school expansion as the primary who work there—to create the sense of implementation of school intervention strategy for turning around the nation’s shared commitment and high models. To encourage such lowest-achieving schools. This was not expectations that have characterized the collaboration and partnership, one the intention. Proposed criterion (D)(2) most successful existing charter schools. measure of an LEA’s strong commitment was aimed more broadly at measuring Discussion: The Department to a State’s Race to the Top plan is the the extent to which a State had created understands that charter school signature of the local teachers’ union the conditions supporting an increase in supporters and operators have different leader on the Memoranda of the number of high-performing charter ideas about the best way to create high-
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performing charter schools. When using Changes: The restart model, described students who attended that school in a charter school conversion as a restart in detail in Appendix C, states that the other schools in the LEA that are within option, LEAs and charter school organization chosen to restart the school reasonable proximity to the closed operators should endeavor to strike a should be ‘‘selected through a rigorous school and that are higher-achieving.’’ review process.’’ balance between allowing sufficient Elevating the School Transformation time for planning and reconfiguring an School Closures Model existing school and moving quickly enough to minimize disruption to Comment: Several commenters Comment: Many commenters students, parents, teachers, and other objected to closing schools, either as recommended that the final notice staff. One way to do this would be to part of a charter conversion or the elevate the fourth option, the school utilize, wherever possible, charter school closure model under criterion transformation model, to the same status school operators, CMOs, or EMOs with (E)(2), because such actions can displace as the first three school intervention experience in converting existing students and disrupt communities. One options, rather than a last resort if the schools to new management. In commenter added that the impact of first three are not possible. Some of addition, every effort should be made to closing schools may be particularly these commenters also asserted that the permit and encourage previously severe in minority communities, where transformation model may be among the enrolled students to enroll in the new there may not be a higher-performing most promising of school intervention charter school. The primary purpose of school nearby, while another observed options, particularly when it involves a turning around the lowest-achieving that closing schools is not always comprehensive approach to turning schools is to give the students in those possible in rural areas. Other around low-performing schools that schools the high-quality education they commenters variously recommended includes systemic behavioral and deserve and need to prepare for further that school closing be used as a school learning supports, a safe and orderly education, college, and careers. intervention option only when a high- climate, promotion of students’ social- performing school is available as an emotional skills and capacities, and the Changes: The restart model, as alternative, is in close proximity to the kind of collaborative working described in paragraph (b) of Appendix closed school, and has room to environment where staff are empowered C, specifically allows for an LEA to accommodate new students. Another to support students. Two commenters convert a school or close and reopen a commenter recommended that LEAs added that the ‘‘additional learning school under a charter school operator, promote the use of inter-district opportunities and supports referenced’’ a CMO, or an EMO that has been transfers for students in closed schools. in the transformation model, as selected through a rigorous review Finally, concerns about the impact of described in the NPP, should be process. closures led one commenter to required under the other school Education Management Organizations recommend that school intervention intervention models as well. Another efforts be targeted on existing schools, commenter asserted that there ‘‘is no Comment: A few commenters as opposed to charter school conversion basis in scholarly research’’ for questioned the proposed role for EMOs or school closing. subordinating the transformation model in school interventions, raising concerns Discussion: The Department to the other three school intervention about the research base underlying the recognizes that school interventions, options. One commenter urged that the use of EMOs and how they would be regardless of the strategy or option fourth option be elevated and that the held accountable. One commenter selected, may lead to some first three options be deemphasized. recommended that the Secretary displacement and disruption for both Another commenter recommended that consider requiring EMOs to have a students and adults. LEAs and schools a State first implement the non-staffing demonstrated record of success in should work together to facilitate a requirements of the transformation managing schools before they are used smooth transition, particularly for model—improving strategies for as part of a school intervention strategy, students and families, when schools are recruitment, retention, and professional and also recommended that EMOs be closed as part of school intervention development; implementing a prohibited from refusing to serve certain plans. We agree that inter-district comprehensive instructional program; students based on student needs. One transfers could help to mitigate the extending learning time and utilizing commenter added that charter schools impact of school closures, and LEAs are community-oriented supports; and should be required to have a already encouraged to promote such promoting family and community demonstrated track record of success. transfer options under section engagement—for ‘‘a reasonable time’’ Discussion: The Department agrees 1116(b)(11) of the ESEA. Also, school before undertaking school governance that LEAs should carefully screen EMOs closing is just one of four available and staffing changes such as those before using them as part of a school school intervention options in this final required by the other school intervention model. The restart model notice; it may not be appropriate or even intervention models described in adopted from the School Improvement possible for some LEAs. In particular, criterion (E)(2) (proposed (D)(3)). Grants program, and described in the school closure model adopted from However, one commenter urged, Appendix C to this notice, requires the the School Improvement Grants consistent with the NPP, that the use of an EMO ‘‘that has been selected program in this notice states that a transformation model be a last resort through a rigorous review process,’’ school to which students from a closed only, such as in a remote rural school which may include an examination of school are transferred must be ‘‘within district that could find it impossible to an EMO’s record of success in managing reasonable proximity’’ to the closed replace most of the staff at one of its schools as well as an analysis of the school. schools. extent to which EMOs have served Changes: The school closure model Discussion: The Department agrees students with diverse educational adopted from the School Improvement with commenters who recommended needs. Charter school operators and Grants program and described in broader latitude for LEAs to use the CMOs would be subject to the same Appendix C to this final notice states transformation model to turn around review requirement under a restart that ‘‘School closure occurs when an their persistently lowest-achieving model. LEA closes a school and enrolls the schools. Criterion (E)(2) includes a
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transformation model as one of the four Discussion: The Department intervention strategy. One commenter models adopted from the School recognizes that there are other ways to observed that many chronically low- Improvement Grants program and structure school intervention models. performing schools have been described in detail in Appendix C of However, our goal with respect to reconstituted or restructured more than this notice. The final notice also criterion (E)(2) is to signal a decisive once, with multiple leadership and removes the provision in proposed break with the past, rather than simply staffing changes, without success. This criterion (D)(3) that the transformation to create a new school improvement commenter urged the Secretary to model can be used only if the other timeline with a menu of interventions, recognize that in many cases LEAs must strategies are not possible. However, we in order to successfully turn around as work to improve the skills of existing are also adding language to criterion many of the nation’s lowest-achieving staff by establishing a fifth (E)(2) specifying that an LEA with more schools as possible. As for combining ‘‘Comprehensive Instructional Reform’’ than nine persistently lowest-achieving the first and fourth models, the option that would emphasize schools may not use the transformation commenter appears to have overlooked curriculum, new instructional model for more than 50 percent of its the significant changes in staffing and approaches, and supports that promise schools. governance that are central to the success. However, another commenter And while the Department does not turnaround model but not required emphasized that ‘‘comprehensive agree that the elements of the under the transformation model. For instructional reform’’ should not be a transformation model should be these reasons, and as described single model, as this could create required under the turnaround and elsewhere in this notice, the school barriers to differentiated instruction. restart models, largely because doing so intervention models adopted from the Discussion: The transformation model would undermine the flexibility to School Improvement Grants program provides flexibility for LEAs to innovate that is a key benefit of and described in Appendix C of this implement comprehensive instructional changing governance and leadership or notice generally retain the structure and reform without significant staff changes. a charter school conversion, the timeline proposed in the NPP, except In addition, the final notice no longer turnaround model described in that the transformation model no longer limits the application of this model to Appendix C specifically permits the is limited to situations where it is not situations where the other three implementation of ‘‘any of the required possible for an LEA to implement one intervention models—turnaround, and permissible activities under the of the other three models. restart, and school closure—are not possible. We also note that the transformation model.’’ However, the Changes: None. transformation model described in Department declines the suggestion by Continuation of Existing School Appendix C requires ongoing, high- one commenter to deemphasize the Intervention Models quality, job-embedded professional other options, primarily because we Comment: One commenter requested development in areas such as subject- believe that changing governance, that the final notice clarify whether a specific pedagogy, instruction that leadership, and staff often are essential school that brought in a CMO or EMO reflects a deeper understanding of the for turning around the lowest-achieving two or three years ago would be community served by the school, and schools; we also note that such actions required under criterion (E)(2) to start differentiated instruction. (i.e., replacing the principal and over with a new intervention. Changes: None. removing ineffective staff) are required Discussion: Appendix C, which Increased Learning Time by the transformation model. describes the school intervention Changes: Criterion (E)(2) (proposed models that we are adopting from the Comment: Several commenters (D)(3)) no longer limits the adoption of School Improvement Grants program, supported the inclusion of extended the transformation model, as described includes language stating that if a school learning time in the turnaround and in Appendix C, as a ‘‘last resort’’ when identified as a persistently lowest- transformation models, while others it is not possible for an LEA to achieving school has implemented, in recommended that all school implement one of the other school whole or in part within the last two intervention models include the intervention models. Instead, it specifies years, an intervention that meets the provision of extended learning time. A that an LEA with more than nine requirements of the turnaround, restart, number of other commenters requested persistently lowest-achieving schools or transformation models, the school that the Department define the term may not use the transformation model may continue or complete the ‘‘extended learning time’’ to include for more than 50 percent of its schools. intervention being implemented. before- and after-school programs as well as summer learning programs, Modifications to School Intervention Changes: We have included the while one other commenter requested Options following language at the end of Appendix C: ‘‘If a school identified as that the Department define the term but Comment: Several commenters a persistently lowest-achieving school did not advocate for a particular proposed modifications to the school has implemented, in whole or in part definition. Several of these commenters intervention models set forth in within the last two years, an recommended using the term criterion (E)(2) (proposed (D)(3)). For intervention that meets the ‘‘expanded learning time’’ instead of example, one commenter recommended requirements of the turnaround, restart, ‘‘extended learning time.’’ A few other that schools subject to intervention or transformation models, the school commenters urged the Department to implement either the turnaround model may continue or complete the promote additional compensation for or the transformation model for three intervention being implemented.’’ teachers who teach during extended years; if these reforms are unsuccessful school hours, while several others the schools would then be required to Instructional Reform advocated for extended learning time convert to a charter school, accept CMO Comment: Numerous commenters strategies that involve outside or EMO management, or close. Another supported comprehensive instructional community partners. One of these commenter recommended combining reform, including differentiated commenters warned that extended the first and fourth models due to their instruction and a standards-based, learning time should not be ‘‘more of similarity. common curriculum, as a school the same.’’ Instead, according to this
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comment, State Race to the Top plans School and Community Partnerships struggling students in school and re- should describe how States and LEAs Comment: One commenter engaging youth who have dropped out will ensure that expanded learning time recommended requiring school and of high school. For example, the is used to introduce students to new, community partnerships under all four transformation model adopted from the more effective methods of instruction. school intervention options, in School Improvement Grants program This commenter also recommended that particular to help transform schools into provides that LEAs may implement the the Department give preference to centers of their communities and to following activities aimed at increasing graduation rates: Credit-recovery proposals that increase learning time by support expanded learning time, and to 30 to 50 percent, consistent with the programs, re-engagement strategies, provide comprehensive learning amount added by the highest- smaller learning communities, supports, more time for enrichment performing charter schools. competency-based instruction and activities, and ongoing mechanisms for Discussion: The Department agrees performance-based assessments, and family engagement and community that increased learning time (as defined acceleration of basic reading and math support. in this notice) can drive significant skills. In addition, the transformation Discussion: The transformation model increases in student achievement. model also provides that LEAs may adopted from the School Improvement Though we know that community-based implement other comprehensive Grants program and described in organizations can play a key role in instructional reform strategies, such as Appendix C of this notice includes as a providing these services in some places, improving the transition from middle to major strategy for increasing learning we decline to give preference to such high school through summer transition efforts in this competition. States and time and creating community-oriented programs or freshman academies, and participating LEAs may choose to schools, as well as a specific increasing rigor by offering engage community-based organizations requirement to provide ‘‘ongoing opportunities to enroll in advanced in efforts to increase learning time as mechanisms for family and community coursework, early-college high schools, described in the State’s plan. We engagement.’’ In addition, the dual-enrollment programs, or thematic appreciate the commenter’s suggestion turnaround model, which also is learning academies that prepare to give preference to proposals that described in detail in Appendix C, students for college and careers, increase learning time by 30 to 50 requires ‘‘schedules and strategies that including supports to help low- percent, but decline to unnecessarily provide increased learning time’’ and achieving students take advantage of limit SEA and LEA flexibility by ‘‘community-oriented services and these programs. specifying the exact threshold that such supports for students,’’ while also Changes: We have adopted a efforts must meet to be considered as permitting the adoption of family- and transformation model from the School having increased learning time (as community-based strategies identified Improvement Grants program that defined in this notice). To avoid in the transformation model. However, includes, as permissible activities under confusion with other initiatives, we the Department declines to add this the comprehensive instructional reform have replaced extended learning time requirement to the other school strategies component, (1) increasing with increased learning time and intervention models, which are focused rigor by offering opportunities for defined the term to mean using a longer in large part on governance changes that students to enroll in advanced school day, week, or year. Lastly, we emphasize autonomy and flexibility for coursework (such as Advanced chose not to require that States provide a school to pursue its own priorities and Placement or International additional compensation for teachers in activities. Baccalaureate programs; or science, extending the school day; we expect Changes: None. technology, engineering, and that States will establish appropriate Dropout Re-Engagement and Recovery mathematics courses, especially those policies as part of the development of that incorporate rigorous and relevant their State plans in consultation with Comment: Several commenters project-, inquiry-, or design-based key stakeholders. advocated the inclusion of programs for contextual learning opportunities), Changes: We have replaced the term re-enrolling or re-engaging high school early-college high schools, dual ‘‘extended learning time’’ with dropouts to the school intervention enrollment programs, or thematic ‘‘increased learning time’’ and defined models in criterion (E)(2) (proposed learning academies that prepare increased learning time to mean using a (D)(3)), such as ‘‘data-driven dropout re- students for college and careers, longer school day, week, or year engagement’’ and the addition of including by providing appropriate schedule to significantly increase the dropout recovery models as an element supports designed to ensure that low- total number of school hours to include of the transformation model. Another achieving students can take advantage additional time for (a) instruction in commenter called for multiple of these programs and coursework; (2) core academic subjects, including pathways—including school-work improving student transition from English; reading or language arts; partnerships, diploma-plus programs, middle to high school through summer mathematics; science; foreign languages; and dual enrollment programs—and transition programs or freshman civics and government, economics; arts; credit based on student performance academies; and (3) increasing history; and geography; (b) instruction rather than instructional time as graduation rates through, for example, in other subjects and enrichment successful models for educating credit-recovery programs, re- activities that contribute to a well- struggling students as well as dropouts. engagement strategies, smaller learning rounded education, including, for Three other commenters advocated communities, competency-based example, physical education, service credit recovery programs, and one instruction and performance-based learning, and experiential and work- commenter recommended the inclusion assessments, and acceleration of basic based learning opportunities that are of small schools that draw on the best reading and mathematics skills. provided by partnering, as appropriate, practices from research on re-enrolling with other organizations; and (c) high school dropouts. Additions to Performance Measures teachers to collaborate, plan, and engage Discussion: The Department agrees Comment: Several commenters in professional development within and that school intervention models should proposed additions to the performance across grades and subjects. include an emphasis on keeping measures for criterion (E)(2). Three
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commenters recommended the student achievement in (at a minimum) to restrict Tier I schools to schools in inclusion of indicators of the reading/language arts and mathematics, restructuring if this group constitutes effectiveness of school intervention as reported by the NAEP and the more than five percent of a State’s models, not just the number of schools assessments required under the ESEA, identified schools; to apply a State’s adopting each strategy, and one decreasing achievement gaps between growth model; or to consider such other commenter suggested collecting student subgroups, increasing high school factors as measures of individual proficiency data for schools graduation rates (as defined in this student growth, writing samples, grades, implementing one of the intervention notice), and increasing college and portfolios. One commenter models. Another commenter enrollment and credit attainment. States suggested that the Department recommended the addition of indicators will not be able to reach these goals determine the lowest-achieving five of school climate, such as the number of unless their State and local plans percent of schools in the Nation rather suspensions and ratings of school safety. address the needs of the student than have each State determine its own One commenter recommended adding subgroups cited by the commenters. lowest-achieving five percent. Other the increase in the number of alternative Consequently, there is no need to commenters recommended changes that schools for re-engaging students who include new requirements regarding include taking into account the length of have dropped out or the increase in the student subgroups in the school time a school has been designated for number of students served by such intervention models described in detail restructuring, measuring gains related to schools. One commenter also in Appendix C to this notice. English language proficiency, and recommended changing the Changes: None. including newly designated Title I performance measure for criterion (E)(2) Comments and Responses on the SIG schools (especially secondary schools) to focus on the percentage of the lowest- NPR that do not yet have an improvement performing schools, rather than the status. number of such schools, in which the As noted earlier, the following Several commenters also suggested first three school intervention options discussion summarizes the comments changing the method for determining will be implemented. Finally, one we received, and our responses, on the ‘‘lack of progress,’’ including using commenter recommended that the ‘‘Tier I’’ and ‘‘Tier II’’ schools proposed subgroups rather than the ‘‘all students’’ performance measures include in the SIG NPR that are now included group, measuring progress in meeting assurances of a whole-school goal- in the definition of persistently lowest- adequate yearly progress targets, and setting process and the guaranteed use achieving schools. The discussion also narrowing achievement gaps. Another of interim or formative assessments. summarizes the comments and our commenter recommended clarifying Discussion: The Department agrees responses on the four school that, even if a school shows gains that there is a wide range of potentially intervention models proposed in the greater than the State average, it should useful performance data that could be SIG NPR. not be considered to be making progress collected about State and local efforts to Definition of Persistently Lowest- if those gains are not greater than zero. turn around their persistently lowest- Achieving Schools Finally, several commenters suggested achieving schools, and we will be that graduation rates be taken into collecting such data through other Comment: A number of commenters account in determining the lowest- grants and data collections. In addition, recommended alternatives to the achieving Title I high schools. One of we note that, under the ESEA, States are process proposed in the SIG NPR for these commenters suggested including already required to publicly report determining the lowest-achieving five in Tier I all Title I high schools in student proficiency data by school. The percent of all Title I schools in improvement, corrective action, or primary purpose of the proposed improvement, corrective action, or restructuring with a graduation rate performance measure for criterion (E)(2) restructuring in the State—that is, ‘‘Tier below 60 percent as well as their feeder is for States to set goals for themselves. I’’ schools. As proposed in the SIG NPR, middle and junior high schools. At the time it applies for a Race to the a Tier I school is a school in the lowest- Discussion: In developing our Top grant, a State may not have achieving five percent of all Title I proposed definition of the lowest- determined the specific schools in schools in improvement, corrective achieving five percent of schools for which its LEAs will intervene; therefore, action, or restructuring in the State, or each State as defined in the SIG NPR, the most appropriate goal for a State to one of the five lowest-achieving Title I we considered several alternatives, set is the number of schools in which it schools in improvement, corrective including the use of the existing ESEA will support interventions each year. action, or restructuring in the State, improvement categories and the Changes: None. whichever number of schools is greater. possibility of using a measure that Under the SIG NPR, to determine this would identify the lowest-achieving five Attention to Student Subgroups ‘‘bottom five percent,’’ a State would percent of schools in the Nation rather Comment: A few commenters have had to consider both the absolute than on a State-by-State basis. The goal recommended that the final notice performance of a school on the State’s was to identify a uniform measure that require all four school intervention assessments in reading/language arts could be applied easily by all States models to include plans for meeting the and mathematics and whether its gains using existing assessment data. We educational needs of students with on those assessments for the ‘‘all started with Title I schools in disabilities, English language learners, students’’ group over a number of years improvement, corrective action, or and other subgroups. were less than the average gains of restructuring as the initial universe from Discussion: The Department has schools in the State for the ‘‘all which to select the lowest-achieving addressed this issue through criterion students’’ group. schools because those are the schools (A)(1)(iii), which will measure the Several commenters said this eligible to receive SIG funds. ESEA extent to which a State’s Race to the Top proposed process was too prescriptive improvement categories were deemed plan will translate into broad statewide and recommended that States have more too dependent on variations in impact, allowing the State to reach its flexibility in determining the lowest- individual subgroup performance, ambitious yet achievable goals, overall achieving five percent. The commenters rather than the overall performance of and by student subgroup, for increasing specifically suggested permitting States an entire school, to reliably identify our
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worst schools. A nationwide measure, restructuring (or the lowest-achieving must identify these schools using the although appealing from the perspective five such schools, whichever number of same criteria as it uses to identify the of national education policy, would schools is greater) (‘‘Tier I’’ schools for lowest-achieving Title I schools in likely have identified many schools in purposes of SIG). This new definition improvement, corrective action, and a handful of States and few or none in also includes any Title I high school in restructuring. the majority of States, making it an improvement, corrective action, or For the reasons noted earlier in this inappropriate guide for the most restructuring that has had a graduation notice, we have also included in the effective use of State formula grant rate of less than 60 percent over a definition any high school that is funds. number of years (as will the ‘‘Tier I’’ eligible for, but does not receive, Title In general, we believe that the definition for SIG purposes). We have I funds and that has had a graduation changes and alternatives suggested by removed language in proposed section rate that is less than 60 percent over a commenters would add complexity to I.A.1.a(ii) of the SIG NPR defining ‘‘a number of years. the method for determining the lowest- school that has not made progress.’’ Changes: The Department has added achieving five percent of schools Comment: Numerous commenters a definition of persistently lowest- without meaningfully improving the expressed support for including achieving schools to this notice that outcome. With the changes noted chronically low-achieving secondary incorporates the lowest-achieving five subsequently, we believe the definition schools that are eligible for, but not percent of secondary schools in a State proposed in the SIG NPR is receiving Title I funds as Tier II schools, that are eligible for, but do not receive, straightforward, can be easily applied as proposed in section I.A.1.b in the SIG Title I funds (or the lowest-achieving using data available in all States, and NPR, including one commenter who five such schools, whichever number of can produce easily understood results in suggested that LEAs be required to fund schools is greater) (‘‘Tier II’’ schools for the form of a list of State’s lowest- Tier II schools. Other commenters, purposes of SIG). This new definition achieving schools that have not however, opposed the use of Title I also includes any high school that is improved in a number of years. funds in non-Title I schools and eligible for, but does not receive, Title Regarding the determination of recommended that other funding be I funds that has had a graduation rate of whether a school is making progress in identified to serve those schools or less than 60 percent over a number of improving its scores on State stated that the inclusion of those years (as will the ‘‘Tier II’’ definition for assessments, the commenters schools is more appropriately addressed SIG purposes). We have removed highlighted the complexity and in the Title I reauthorization. One language in proposed section I.A.1.b of potential unreliability of measuring commenter suggested that it would not the SIG NPR that required a comparison year-to-year gains on such assessments. be appropriate to provide Title I funds of the achievement of secondary schools In response, we are simplifying this to such schools when the SIG NPR to Tier I schools. aspect of the definition to give SEAs would restrict the number of Title I General Comments on the Four greater flexibility in determining a schools that can be served in Tier I. Intervention Models school’s lack of progress on State Discussion: We believe that low- assessments over a number of years. achieving secondary schools often Comment: One commenter supported We also agree that it is important to present unique resource, logistical, and the Secretary’s intent in proposing the include Title I high schools in pedagogical challenges that require four interventions in the SIG NPR. The improvement, corrective action, or rigorous interventions to address. Yet, commenter noted that the majority of restructuring that have low graduation many such schools that are eligible to SIG funds are intended to target the very rates in the definition. The Secretary has receive Title I funds are not served lowest-achieving schools in the made addressing our Nation’s because of competing needs for Title I Nation—schools that have not just unacceptably high drop-out rates—an funds within an LEA. The large amounts missed their accountability targets by estimated 1 million students leave of ARRA funds—available through narrow margins or in a single subgroup. school annually, many never to return— Stabilization, Race to the Top, and Rather, they are schools that have a national priority. In recognition of this SIG—present an opportunity to address ‘‘profoundly fail[ed]’’ their students ‘‘for priority, and in response to the needs of these low-achieving some time.’’ Accordingly, the recommendations from commenters, we secondary schools. Accordingly, we commenter acknowledged that the four are including in the definition any Title have continued in this notice to include interventions are appropriately designed I high school in improvement, secondary schools that are eligible for, to engage these schools in bold, corrective action, or restructuring that but do not receive, Title I funds in the dramatic changes or else to close their has had a graduation rate that is less definition of the persistently lowest- doors. than 60 percent over a number of years. achieving schools in a State. Conversely, several commenters Accordingly, we have made these As proposed in the SIG NPR, such suggested that the four interventions are changes and incorporated the process secondary schools would have been too prescriptive and do not leave room for determining the lowest-achieving eligible if they were equally as low- for State innovation and discretion to five percent of Title I schools in achieving as a Tier I school. We realized fashion similarly rigorous interventions improvement, corrective action, or that this standard was too vague, that may be more workable in a restructuring—also known as Tier I particularly in light of the rigorous particular State. The commenters noted schools for purposes of SIG funds—into interventions that would be required if that for some school districts, a new definition of persistently lowest- an SEA identified, and an LEA decided particularly the most rural districts, achieving schools in this notice. to serve, such a school. As a result, we none of the interventions may be Changes: The Department has added have changed the definition to include feasible solutions. In addition, several a definition of persistently lowest- secondary schools that are eligible for, commenters rejected the idea that there achieving schools to this notice that but do not receive, Title I funds and that should be any Federal requirements incorporates the process described in are among the lowest-achieving five governing struggling schools. The the SIG NPR for determining the lowest- percent of such schools in a State (or the commenters suggested that schools in achieving five percent of Title I schools lowest five such schools, whichever need of improvement be permitted to in improvement, corrective action, or number of schools is greater). An SEA engage in self-improvement strategies
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tailored to each individual school’s specific reform approaches, thus restructuring continues to grow; in needs as determined at the local level negating the need for a ‘‘fifth model.’’ particular, the number of chronically based on local data, rather than being We understand, for example, that school low-achieving Title I schools identified mandated to adopt specific models by closure may not work in some LEAs, but for restructuring has roughly tripled the Federal Government. that leaves the turnaround, restart, or over the past three years to more than Discussion: We disagree that the four transformation models as possible 5,000 schools. SEAs have thus far models limit State innovation. Each options for them. We also know that not helped no more than a handful of these model provides flexibility and permits all States have a charter school law, schools to successfully restructure and LEAs to develop approaches that are limiting the restart options available to exit improvement status, in large part, tailored to the needs of their schools LEAs in such States. However, even we believe, because of an unwillingness within the broad context created by where charter schools are not an option, to undertake the kind of radical, each model’s requirements. We do not an LEA could work with an Education fundamental reforms necessary to believe that any one model is Management Organization (EMO) to improve the persistently lowest- appropriate for all schools; rather, it is restart a failed school or could pursue achieving schools. the Department’s intention that LEAs one of the other three intervention Finally, although we believe this select the model that is appropriate for models. And we understand that some recent history of failed school each particular school. rural areas may face unique challenges improvement efforts justifies using Changes: None. in turning around low-achieving ARRA SIG funds to leverage the Comment: Several commenters schools, but note that the significant adoption of the more far-reaching suggested adding a fifth intervention amount of funding available to reforms required by the four school option. One commenter, for example, implement the four models will help to intervention models, we note that Part suggested permitting States to propose overcome the many resource limitations A of Title I of the ESEA continues to an alternative, but rigorous, intervention that previously have hindered make available nearly $15 billion model for approval through a peer successful rural school reform in many annually, as well as an additional $10 review process. The commenter noted areas. billion in fiscal year 2009 through the that whatever accountability measure is The four school intervention models ARRA, that SEAs and LEAs may use to adopted in the SIG notice of final described in the SIG NPR also are develop and implement virtually any requirements should serve to ensure internally flexible, permitting LEAs to reform strategy that they believe will that the model is held accountable for develop their own approaches in the significantly improve student results. Another commenter suggested a broad context created by the models’ achievement and other important ‘‘scale up’’ model, in which an LEA requirements. For example, the educational outcomes in Title I schools. could use SIG funds to expand turnaround and restart models focus on In particular, we would applaud State interventions with documented success governance and leadership changes, and local efforts to use existing Title I in producing rapid improvement in leaving substantial flexibility and funds to scale up successful student achievement within that LEA or autonomy for new leadership teams to interventions or to build State and local in another LEA with similar develop and implement their own capacity to develop and implement demographics and challenges. Yet comprehensive improvement plans. other promising school intervention another commenter suggested adding a Even the transformation model includes ‘‘supported transformation’’ model to models. For all of these reasons, we a wide variety of permissible activities decline to add a fifth school accommodate, in particular, the needs from which LEAs may choose to of children in low-achieving schools in intervention model to this notice. supplement required elements, which Changes: None. small, rural communities that lack the are primarily focused on creating the capacity to transform their schools. The conditions to support effective school Turnaround Model commenter identified the need for an turnarounds rather than the specific Principal and Staff Replacement SEA to build the capacity of struggling methods and activities targeting the LEAs by working to develop models for academic needs of the students in the Comment: Many commenters opposed intervention, to identify specific school. replacing principals and staff as part of evidence-based intervention strategies, We also note that over the course of the turnaround model. Although several and to provide ongoing, intensive the past eight years, States and LEAs commenters acknowledged that poor technical, pedagogical, and practical have had considerable time, and have leadership and ineffective staff assistance so as to increase LEAs’ been able to tap new resources, to contribute to a school’s low capacity to assist their low-achieving identify and implement effective school performance, a majority claimed that schools. turnaround strategies. Yet they have staff replacement has not been Discussion: We included the four demonstrated little success in doing so, established as an effective reform school intervention models in the SIG particularly in the Nation’s persistently strategy, others stated that such a NPR after an extensive examination of lowest-achieving schools, including an strategy is not a realistic option in many available research and literature on estimated 2,000 ‘‘dropout factories.’’ communities that already face teacher school turnaround strategies and after Under the ESEA, States have been and principal shortages, and one outreach to practitioners. Our goal, required to set up statewide systems of commenter suggested that replacement which we believe was achieved, was to support for LEA and school requirements associated with identify fundamental, disruptive improvement; to identify low-achieving turnaround plans would discourage changes that LEAs could make in order schools for a range of improvement, teachers and principals from working in to finally break the long cycle of corrective action, and restructuring struggling schools. educational failure—including the activities; and to use the school In addition, many commenters failure of previous reforms—in the improvement reservation under section opposed sanctioning principals and Nation’s persistently lowest-achieving 1003(a) of the ESEA to fund such staff, partly because, as one commenter schools. We also believe that these improvement activities. However, the claimed, the turnaround model assumes models, despite their limited number, overall number of schools identified for that most problems in a school are potentially encompass a wide range of improvement, corrective action, and attributable to these individuals. One
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stated that principals face ‘‘trying’’ professional development opportunities. Finally, the turnaround model circumstances and another stated that Others recommended (1) providing a includes significant provisions aimed at the proposed requirements ignore the principal with the autonomy to make supporting teachers. For example, the ‘‘vital role’’ that principals play in high- his or her own firing and hiring SIG NPR called for ‘‘ongoing, high- need schools. These commenters stated decisions instead of requiring the quality, job-embedded professional that other factors—such as poverty, lack replacement of 50 percent of the staff; development to staff,’’ as well as of proper support, and tenure and (2) allowing staff to reapply for their increased time for collaboration and collective bargaining laws—should be positions; (3) retaining principals who professional development for staff. addressed before decisions are made to were recently hired; (4) providing These supports for teachers and other replace principals and staff. One principals with a ‘‘window’’ of staff are retained in this final notice. commenter claimed that principals and opportunity to improve their schools Changes: We have modified the teachers in low-achieving schools could before being replaced; (5) suggesting provisions in the turnaround model in perform their jobs if they are given that the replacement requirement paragraph (a)(1)(i) to give the new adequate training and support and extend to superintendents and boards of principal of a turnaround school working conditions are improved. education; (6) retaining at least 50 ‘‘sufficient operational flexibility Another opposed the replacement percent of current staff who reapply and (including in staffing, calendars/time, requirement because the commenter meet all of the requirements of the and budgeting) to implement fully a believed a stable and consistent staff is redesigned school; and (7) focusing on comprehensive approach in order to a key factor in school improvement. staff qualifications and putting in place substantially improve student Discussion: We understand that effective staff rather than on a particular achievement outcomes and increase replacing leadership and staff is one of target level of replacements. high school graduation rates.’’ As the most difficult aspects of the four Discussion: We agree with some of the described earlier, we have also revised models; however, we also know that changes to the turnaround model paragraph (a)(1)(ii) to require that an many of our lowest-achieving schools suggested by commenters. For example, LEA use locally adopted competencies have failed to improve despite the new language in paragraph (a)(1)(i) of to measure the effectiveness of staff who repeated use of many of the strategies the turnaround model recognizes the can work within the turnaround suggested by the commenters. The vital role played by the principal and environment to meet the needs of emphasis of the ARRA on turning acknowledges that new principals need students. In addition, instead of the around struggling schools also reflects, authority to make key changes required requirement that an LEA replace ‘‘at in part, an acknowledgement by the to turn around a failing school. Under least 50 percent of the staff’’ in a Congress that past efforts have had this new language, the new principal of turnaround school, paragraph limited or no success in breaking the a turnaround school would have (a)(1)(ii)(A) of the definition requires an cycle of chronic educational failure in ‘‘sufficient operational flexibility LEA to screen and rehire ‘‘no more than the Nation’s persistently lowest- (including in staffing, calendars/time, 50 percent’’ of the existing staff. achieving schools. and budgeting) to implement fully a Comment: Numerous commenters Accordingly, the Department believes comprehensive approach to expressed concerns that a national that dramatic and wholesale changes in substantially improve student shortage of principals and teachers leadership, staffing, and governance— achievement outcomes and increase would prevent successful such as those required by the high school graduation rates.’’ implementation of the turnaround turnaround model—are an appropriate We also recognize that the staff model. Two commenters stated that, in intervention option for creating an selected for a turnaround school must order to replace half of the staff as entirely new school culture that breaks have the skill and expertise to be required by the turnaround model, an a system of institutionalized failure. effective in this context. We are adding LEA would likely be forced to hire less Although we acknowledge the language clarifying that all personnel experienced teachers and rely on possibility that the turnaround model must be screened and selected based on emergency credentials or licensure to could discourage some principals and locally adopted competencies to fully staff a turnaround school. One teachers from working in the lowest- measure their effectiveness in a commenter claimed that research shows achieving schools, others will likely be turnaround environment. that large pools of available applicants attracted by the opportunity to In addition, while the SIG NPR would are essential for successful replacement participate in a school turnaround with have required an LEA to replace at least of principals and teachers. Another other committed staff. In addition, other 50 percent of the staff of a turnaround commenter stated that there is a Federal programs, such as the Teacher school, new paragraph (a)(1)(ii)(A) of ‘‘national shortage of transformational Incentive Fund and Race to the Top the turnaround model requires an LEA, leaders’’ who can lead turnaround programs, are helping to create after screening all staff using locally schools. Further, many commenters incentives and provide resources that adopted competencies, to rehire no claimed that replacing half of a school’s can be used to attract and reward more than 50 percent of the school’s staff would be difficult or even effective teachers and principals and staff. Further, some commenters appear impossible in rural schools and small improve strategies for recruitment, to have overlooked proposed section communities. One commenter asserted retention, and professional I.B.1 in the SIG NPR, which would give that the shortage of teachers in rural development. LEAs flexibility to continue areas would disqualify these LEAs from Changes: None. implementing interventions begun applying for school improvement funds. Comment: A number of commenters within the last two years that meet, in Another stated that even with recommended changes to the principal whole or in part, the requirements of the recruitment incentives it would be and staff replacement requirements. One turnaround, restart, or transformation difficult to fill staff vacancies. One commenter proposed a detailed ‘‘fifth models and, thus, would in many cases commenter urged the Secretary to take model’’ that focused upon providing allow an LEA to retain a recently hired such shortages into account before additional support to teachers by principal in a turnaround school. We requiring ‘‘blanket firings’’ of teachers. improving working conditions, such as are retaining this flexibility provision in In addition, several commenters reducing class size and providing this notice. observed that chronically low-
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performing schools already suffer from can work within the turnaround Comment: Many commenters claimed a number of vacancies due to high staff environment to meet the needs of that teacher tenure, State collective turnover rates. In fact, one commenter students.’’ If required by State laws or bargaining laws, and union contracts believed replacing 50 percent of the staff union contracts, principals and staff prevent school administrators from was not a ‘‘tough’’ consequence because may have to be reassigned to other replacing staff as required by the these schools already experience high schools as necessary. turnaround model. Several commenters turnover. Changes: As described earlier, we stated that union contracts would force These concerns led several have revised paragraph (a)(1)(ii) to school administrators to reassign commenters to recommend flexibility require that an LEA use locally adopted dismissed teaching staff to other regarding the staff replacement competencies to measure the schools, and the turnaround model requirement of the turnaround model, effectiveness of staff who can work would not solve the problem of including the opportunity to request a within the turnaround environment to removing ineffective teachers from the waiver if an LEA could demonstrate an meet the needs of students. The LEA classroom. One commenter asked if an inability to fill vacancies, and a required must then screen all existing staff before LEA would have to negotiate staff evaluation before principals and staff rehiring no more than 50 percent of replacement with the union or if the can be replaced. Other commenters them. Federal grant requirements supersede opposed the replacement of principals Comment: Numerous commenters State due process laws. One commenter without consideration of such factors as claimed that there is little research noted that the Department would have years of experience and district-level supporting the replacement of to provide ‘‘involuntary transfer support, recommended a three-year leadership and staff in school authority’’ to LEAs in order for them to window in which to make replacement turnaround efforts. One commenter implement the turnaround model in decisions based upon multiple cited a 2008 Institute of Education collective bargaining States. measures, and suggested the provision Sciences (IES) report, ‘‘Turning Around Several commenters called for the of high-quality professional Chronically Low-Performing Schools,’’ Department to foster collaboration with development before replacing any staff. that, according to the commenter, teacher unions as well as the larger Discussion: We recognize that the recommends that decisions to remove community. One of these commenters replacement requirement will present staff should be made on an individual claimed that collaboration ‘‘increases challenges for LEAs, particularly in basis. Several others also asserted that leadership and builds professionalism’’ rural areas, where highly effective and recommended that evidence of the proposed requirement to replace at principals and teachers capable of collaboration be documented. Another least 50 percent of staff was arbitrary, leading educational transformation may asserted the involvement of school- with two commenters recommending be in short supply; however, the based personnel in decision-making is instead that the Department ‘‘empower difficulty of identifying new qualified key to the successful implementation of the turnaround principal with the teachers and school leaders for a school interventions. Another autonomy to hire, based on merit, for turnaround school must be measured recommended that an LEA seek every position in the school.’’ against the enormous human and ‘‘feedback’’ from all stakeholders, economic cost of accepting the status Discussion: We are not claiming that including students, parents, and unions, quo for the Nation’s persistently lowest- merely replacing a principal and 50 as to whether an intervention is achieving schools. We simply cannot percent of a school’s staff is sufficient to ‘‘feasible or warranted.’’ afford to continue graduating hundreds turn around a low-achieving school. Discussion: We recognize that of thousands of students annually who Although principal and staff collective bargaining agreements and are unprepared for either further replacement are key features of the union contracts may present barriers to education or the workforce, or to permit turnaround model proposed in the SIG implementation of the turnaround roughly one million students to drop NPR, they are not the only features. The model; however, we do not believe out of high school each year, many of strength of the turnaround model lies in these barriers are insurmountable. In them never to return to school. Instead, its comprehensive combination of particular, drawing upon pockets of States and LEAs must work together to significant staffing and governance success in cities and States across the recruit, place, and retain the effective changes, an improved instructional country, the Secretary believes LEAs principals and staff needed to program, ongoing high-quality and unions can work together to bring implement the turnaround model. The professional development, the use of about dramatic, positive changes in our Department is supporting these efforts data to drive continuous improvement, persistently lowest-achieving schools. through Federal grant programs that can increased time for learning and for staff Accordingly, the Department provide resources for improving collaboration, and appropriate supports encourages collaborations and strategies used to recruit effective for students. The staffing and partnerships between LEAs and teacher principals and teachers, such as the governance changes are intended unions and teacher membership Teacher Incentive Fund program, which primarily to create the conditions associations to resolve issues created by helps increase the number of effective within a school, including school school intervention models in the teachers teaching poor, minority, and climate and culture, that will permit context of existing collective bargaining disadvantaged students in hard-to-staff effective implementation of the other agreements. We also encourage LEAs to subjects and schools. elements of the turnaround model. collaborate with stakeholders in schools Finally, we wish to clarify that the Dramatic changes in leadership, staff, and in the larger community as they requirements for the turnaround model and governance structure help lay the implement school interventions. do not require ‘‘blanket firings’’ of staff. groundwork to create the conditions for Changes: None. The Department agrees that staff should autonomy and flexibility that are Comment: Many commenters stated be carefully evaluated before any associated with successful turnaround that the term ‘‘staff’’ was not clearly replacement decisions are made and has efforts. Accordingly, we decline to defined. One commenter presumed it added new language requiring LEAs to remove the requirement for replacing excluded maintenance, food services, use ‘‘locally adopted competencies to staff in a turnaround model. and other support staff. Another stated measure the effectiveness of staff who Changes: None. that the Department should allow LEAs
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to develop their own definition of Comment: Numerous commenters transformation model and suggested ‘‘staff,’’ and permit LEAs to determine stated that decisions regarding school that the turnaround model provide a whether non-instructional staff should restructuring are best decided on the similar level of detail. Some of these be included in the replacement local, rather than the Federal, level. One commenters recommended that the calculus. Two commenters also commenter opposed the requirements turnaround model incorporate some of requested greater clarity regarding the for the turnaround model as being too the specific provisions contained in the meaning of ‘‘new governance.’’ prescriptive, and another recommended transformation model. For example, one Discussion: We believe that, in high- that the local school board be provided commenter suggested that the achieving schools facing the most with the discretion to determine how turnaround model include the challenging of circumstances, every best to implement the turnaround transformation model’s provisions adult in the school contributes to the model. One commenter agreed that regarding implementation of school’s success, including the ‘‘ineffective staff and leadership should instructional changes. Another principal, teachers, non-certificated be replaced in order for school commenter specifically recommended staff, custodians, security guards, food improvement to work,’’ but stated that that the turnaround model incorporate service staff, and others working in the the turnaround model’s ‘‘one-size-fits- the transformation model’s criteria for school. Conversely, in a persistently all formula may not be the best teacher effectiveness. lowest-achieving school, we believe that approach for all schools.’’ Two Discussion: We agree that the no single group of adults in the school commenters specifically stated that the turnaround model in the SIG NPR is responsible for a culture of persistent decision to remove a principal and staff lacked clarity and potentially created failure. For this reason, our general should be determined by a local school confusion about whether applicants guidance is that an LEA should define board. Similarly, another commenter could draw upon permissible activities ‘‘staff’’ broadly in developing and noted that decisions to replace a described in the transformation model. implementing a turnaround model. The principal and staff should be based The Department did not intend to limit Department declines to define the term upon ‘‘local data’’ rather than Federal LEA discretion in adapting elements of ‘‘staff’’ in this notice, but plans to issue requirements that are not tailored to an the transformation model to the guidance that will clarify this and other individual school’s needs. One of these turnaround model. Accordingly, we are issues related to the turnaround model. commenters stated that local decision- adding new language in paragraph As for the term ‘‘governance,’’ the making is particularly important if a (a)(2)(i) to clarify that an LEA language in paragraph (a)(1)(v) suggests school has been underperforming for a implementing the turnaround model a number of possible governance period longer than the ‘‘principal’s may implement any of the required and alternatives that may be adopted in the tenure or if the principal has begun a permissible activities under the context of a turnaround model. The transformative process that could be transformation model. Department declines to provide a more harmed by a leadership change.’’ Changes: We have clarified in specific definition in order to permit Discussion: An LEA is free to exercise paragraph (a)(2)(i) that an LEA LEAs the flexibility needed to adopt a local control and use local data and implementing a turnaround model may turnaround governance structure that leadership to determine which of the also implement other strategies such as meets their local needs and four school intervention models to ‘‘[a]ny of the required and permissible circumstances. follow in turning around a persistently activities under the transformation Changes: None. lowest-achieving school. However, after model.’’ In addition, we have made Comment: Several commenters asked nearly a decade of broad State and local changes in the turnaround model that that the Department consider the discretion in implementing, with little correspond to changes we made in possible negative consequences of success, the school improvement response to comments on the replacing staff on a school and provisions of the ESEA, the Department transformation model. The specific community, with one commenter believes, for the purpose of this changes are noted subsequently in this suggesting that replacing half of the staff program, it is appropriate and necessary notice in our discussion of comments on could result in more damage ‘‘to a to limit that discretion and require the the transformation model. fragile school than no change at all.’’ use of a carefully developed set of Restart Model Another commenter stated that school intervention models in the maintaining a consistent staff is a key to Nation’s lowest-achieving schools. In Comment: Many commenters opposed school success. particular, the turnaround and the restart model described in the SIG Discussion: The Secretary disagrees transformation models include a NPR because, they claimed, charter that implementing a turnaround model combination of staffing, governance, and schools generally do not perform better would be worse than ‘‘no change at all.’’ structural changes with specific than regular public schools. In The schools that would implement a comprehensive instructional reforms particular, these commenters cited turnaround model have, by definition, that the Department believes hold great recent research from the Center for persistently failed our children for promise for effective investment of the Research on Education Outcomes years, and dramatic and fundamental $3 billion provided for the SIG program (CREDO) at Stanford University change is warranted. In addition, as by the ARRA. showing that fewer than one-fifth of stated elsewhere in this notice, the Changes: None. charter schools demonstrated gains in commenters overlook the fact that the student achievement that exceeded other options—the transformation, Relationship Between Turnaround and those of traditional public schools. One school closure, and restart models—do Transformation Models commenter also mentioned a RAND not require replacement of 50 percent of Comment: Several commenters study highlighting the low performance a school’s staff. If an LEA believes that believed the turnaround model lacked of charter schools in Texas and a study it cannot successfully meet the sufficient detail and did not provide by researchers at Johns Hopkins requirements of the turnaround model, adequate direction to LEAs attempting University showing that most EMO- we recommend that it consider one of to implement the model. In contrast, operated schools were outperformed by the other three options. several commenters appreciated the traditional public schools. Most of these Changes: None. level of detail contained in the commenters proposed broadening or
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strengthening the restart option, but one schools are just one option under the Clarifying Restart Operator Definitions commenter recommended removing it restart model. Contracting with an EMO Comment: One commenter from the list of permitted school is another restart option that may recommended that the Department intervention models. One commenter provide sufficient flexibility in States provide a definition of CMO and EMO, claimed that, where charter schools had without charter school laws or in rural while other commenters suggested raised student achievement, in most areas where few charter schools operate. changes or requested clarification of the cases it was attributable to high student An EMO also may be able to develop definitions of CMO and EMO provided attrition rates brought about by and implement a plan that permits in the SIG NPR. One commenter demanding school schedules and students to stay in their school while recommended defining a CMO as an behavioral rules that did not work for all undergoing a restart. For example, some organization that ‘‘operates or manages students. A few commenters noted EMOs hired to turn around a low- a school or schools’’ rather than, as in either that some States do not allow achieving school may begin planning for the SIG NPR, ‘‘operates charter charter schools or that the restart model the turnaround in late winter or early schools.’’ This commenter also urged would be unlikely to work in rural spring, hire and train staff in late spring the Department to define ‘‘whole school areas. Several commenters also opposed and early summer, reconfigure and re- operations’’ as applied to the definition the restart model because it might equip the school—including the of EMO. Another commenter displace students and disrupt existing acquisition of curricular materials and recommended that the Department efforts to build community schools; technology—during the summer, and include charter schools operated or another commenter recommended that then reopen promptly in the fall, managed by an LEA in the definition of any planning and reorganization for a resulting in minimal, if any, disruption CMO. One commenter also urged the restart model take place during the to students and parents. Department to establish reporting school year, while students remain in Changes: We have changed the requirements for CMOs and EMOs, the school, so that there would be no language in paragraph (b) to define a disruption in services if the school were including data on student achievement, closed and then reopened as a restart restart model as one in which an LEA the impact of reforms on student school. converts a school or closes and reopens achievement, information on how CMOs Discussion: We acknowledge that the a school under a charter school and EMOs serve students with available research on the effectiveness operator, a charter management disabilities, and other accountability of charter schools in raising student organization (CMO), or an EMO that has data. Finally, two commenters also achievement is mixed, that some State been selected through a rigorous review suggested that the Department award laws significantly limit the creation or process. funding directly to CMOs and EMOs to pay for planning, outreach, and training expansion of charter schools, and that Defining Rigorous Review smaller communities, particularly in staff for a restart effort. rural areas, may not have sufficient Comment: Several commenters Discussion: We included definitions access to providers or teachers to supported the requirement in the SIG of CMO and EMO in the preamble of the support the creation of charter schools. NPR that LEAs select a charter school SIG NPR and are adding these However, there are many examples of operator, a CMO, or an EMO through a definitions in the definition of restart high-quality charter schools, and the ‘‘rigorous review process.’’ In general, model for clarification purposes. We Secretary believes very strongly that these commenters viewed this agree that the definition of CMO should high-achieving charter schools can be a requirement as essential to ensuring the include organizations that operate or significant educational resource in quality of a restart model. Commenters manage charter schools and have made communities with chronically low- also asked for clarification of how such this change to the CMO definition in achieving regular public schools that a review would be conducted, including this notice accordingly. Although a have failed to improve after years of guidance for SEAs and LEAs and charter school may exist as part of an conventional turnaround efforts. opportunities for parent and community LEA, it is unlikely that the LEA would Although they are not a ‘‘silver bullet’’ involvement in reviewing and selecting be responsible for operating or for failing schools or communities, a a restart school operator. One managing the charter school. Therefore, more balanced view of the results commenter raised a concern about how we have not expressly included LEAs in produced by charter schools suggests it would be possible to review the definition of CMO. We are retaining that they offer promising and proven rigorously a new charter school the EMO definition from the SIG NPR, options for breaking the cycle of operator, CMO, or EMO. and believe the emphasis on ‘‘whole- educational failure and fully merit school operation’’ is sufficient to Discussion: We believe that SEAs and inclusion in the restart model. distinguish EMOs from other providers LEAs should have flexibility to develop The Department also recognizes the that may help with certain specific concerns expressed by commenters their own review processes for charter aspects of school operation and about the potential disruption to school operators, CMOs, and EMOs, management, but that do not assume students, parents, and communities that based both on local circumstances and full responsibility for the entire school, may be connected with a restart plan on their experiences in authorizing as is required by the restart model. that involves closing and then charter schools. We will provide The Department does not believe it is reopening a school. To help address this guidance and technical assistance in necessary to add new or additional concern, we are adding language to this this area, but will leave final decisions reporting requirements for EMOs and notice allowing a school conversion— on review requirements to SEAs and CMOs, as their performance will be and not just closing and reopening a LEAs. We believe flexibility in defining captured by the reporting metrics school—to qualify as an acceptable ‘‘rigorous review’’ is warranted because established in the final SIG notice. More restart model. of the wide variation in local need and specifically, SEAs and LEAs already At the same time, the Department community context as well as in the must report on the intervention model emphasizes that just as the restart model size, structure, and experience of charter used for each persistently lowest- is one of four school intervention school operators, CMOs, and EMOs. achieving school, as well as outcome models supported by this notice, charter Changes: None. data for those schools, including
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outcome data disaggregated by student approaches may permit implementation school without a meaningful plan for subgroups. As for providing SIG funding of a restart model with minimal turning it around—but should not directly to CMOs and EMOs, the SIG disruption for students, parents, and involve mandating or otherwise program is a State formula grant communities. In general, an LEA would requiring specific reform activities. program, and the Department must be responsible for authorizing or However, the review process may allocate funds to States in accordance contracting with charter school require operators to demonstrate that with the requirements of section 1003(g) operators, CMOs, or EMOs for their strategies are informed by research of the ESEA. Moreover, the only eligible implementation of a restart model. The and other evidence of past success. SIG subgrantees are LEAs. precise form of this contract or Changes: None. Changes: We have included the agreement would be up to State or local Comment: One commenter definitions of CMO and EMO in the authorities and could include each of recommended requiring the review definition of restart model. We have the alternatives mentioned by the process for CMOs and EMOs to include also modified the definition of CMO commenters. However, regardless of the curriculum and staffing plans for slightly to reflect the fact that a CMO lines of authority, autonomy and meeting the needs of subgroups of may either operate or manage charter freedom to operate independently from students, including students with schools. the State or LEA are essential elements disabilities and limited English Flexibility Under the Restart Model of the restart model. A group of proficient students. Another commenter individuals, including teachers, would suggested that the review process Comment: Several commenters be eligible to manage a restart school so include examining the extent to which recommended greater flexibility for long as they met the local requirements a restart operator sought to ensure that LEAs implementing the restart model, of the rigorous review process included restart schools would serve all former including options to create magnet in the restart model. students by requiring States to collect schools or ‘‘themed’’ schools. Another Changes: We have revised the first data on the number of students from commenter, claiming that few charter sentence of the definition of restart school operators, CMOs, or EMOs have low-income families, students with model to read as follows: ‘‘A restart disabilities, and limited English experience in ‘‘whole school takeover,’’ model is one in which an LEA converts recommended permitting a phase-in proficient students served by a restart a school or closes and reopens a school school compared with the number of approach to charter schools that would under a charter school operator, a allow a charter school operator to start those students served by the school it charter management organization replaced. with two or three early grades and (CMO), or an education management Discussion: Restart operators, by gradually ‘‘take over’’ an entire school. organization (EMO) that has been definition, have almost complete Discussion: We believe that selected through a rigorous review freedom to develop and implement their considerable flexibility regarding the process.’’ type of school program offered is Comment: Several commenters own curricula and staffing plans, and inherent in the restart model, which recommended that the Department the Department declines to place limits focuses on management and not on include specific elements of the in this area in recognition of the core academic or curricular requirements. turnaround and transformation models emphasis of the restart model on For example, restart operators would be in the restart model, including outcomes rather than inputs. The free to create ‘‘themed’’ schools, so long improved curricula and instruction, requirement to enroll any former as those schools permit enrollment, student supports, extended learning student who wishes to attend the school within the grades they serve, of any time, community involvement, and will help to ensure that charter school former student who wishes to attend. partnering with community-based operators, CMOs, and EMOs include Additionally, LEAs have the flexibility organizations. Similarly, one commenter serving all existing groups of students in to work with providers to develop the noted that a restart model might permit their restart plans. Moreover, the appropriate sequence and timetable for a school to reopen as a charter school effectiveness of these curricula and staff a restart partnership. Whether through while changing little inside the school changes in meeting the needs of ‘‘phase-in’’ models or complete and urged the Department to require subgroups of students, including conversions, the Department encourages restart schools to use a model of reform students with disabilities and limited SEAs and LEAs to take into account that has been proven effective or that English proficient students, will be local context and need in making these includes evidence-based strategies. measured by the metrics in the final SIG decisions. Another commenter urged the notice, which will include disaggregated Changes: None. Department to encourage use of the achievement data by student subgroup. Comment: Many commenters asked restart model to better serve high-risk We encourage SEAs and LEAs to for clarification regarding various students and help dropouts reconnect to analyze these data to ensure that aspects of the restart model, including school. subgroups of students are properly whether it includes conversion of Discussion: We note that restart included in restart schools and that existing schools, who would have models could include nearly all of the their needs are addressed. authority over the operator of restart specific reform elements identified Changes: None. schools (e.g., LEA, SEA, independent under the turnaround and Comment: A few commenters governing board, or a State or local transformation models, but decline to expressed concern that charter schools authorizer), and whether a group of require the use of any particular element are not subject to the same oversight, individuals (e.g., teachers) could or strategy. The restart model is regulation, or accountability as are manage a restart school. specifically intended to give operators regular public schools. Other Discussion: We have changed the flexibility and freedom to implement commenters emphasized the definition of restart model to clarify that their own reform plans and strategies. importance, particularly in the case of it includes conversion of an existing The required rigorous review process charter school conversions, of ensuring school and not just strategies involving permits an LEA to examine those plans autonomy, flexibility, and freedom from closing and reopening a school. In and strategies—and helps prevent an district rules and collective bargaining particular, we believe that conversion operator from assuming control of a agreements, so that charter schools can
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implement their own cultures and Other commenters, however, expressed neighborhood, parents often find it more practices. a number of logistical concerns with difficult to feel a sense of belonging at Discussion: The restart model is this intervention. Some noted that the school or ownership of their child’s specifically intended to give providers closing schools is often not feasible in education. Another commenter noted freedom from the rules and regulations rural areas in which the distance that school closings often anger parents, governing regular public schools, in between schools is too great to make exacerbate overcrowding, increase recognition of the fact that, while such practical enrolling students from a safety and security concerns in rules and regulations may be effective in closed school in higher-achieving neighboring schools, and place students requiring certain kinds of inputs, such schools. Others noted that many LEAs who need specific supports in schools as teacher qualification requirements or do not have multiple schools at the that may not be able to provide those a uniform length of the school day or same grade level in which to enroll supports. One commenter expressed year, they have not been demonstrated students from a closed school. Still concern that closing a school may not to have a significant impact on others noted capacity issues that would address the educational needs of educational outcomes. Moreover, many prevent schools from accommodating specific students, which may be masked successful charter schools have additional students or the lack of high- within a higher-achieving school. achieved outstanding results by achieving schools in which to enroll Another commenter suggested the need changing these inputs, such as by hiring students from a closed school. One for an ‘‘educational impact statement’’ non-traditional but skilled teachers and commenter noted that this intervention before a school is closed, and one by extending the length of the school would not be feasible on a large scale in suggested that an LEA have a detailed day. The Department believes that the large, urban LEAs with limited plan demonstrating how support would outcome metrics established in the final resources and substantial numbers of be provided to students and their SIG notice will ensure accountability for low-achieving students. Another families transitioning to different the performance of restart schools. commenter recommended that this schools. Several commenters suggested Changes: None. intervention be limited to those LEAs that the final requirements provide for Comment: One commenter expressed with the capacity to enroll affected parent and community input before a concern that LEAs could use the restart students in other, higher-achieving school is closed. model to close an existing charter schools. Discussion: The Department school that, while successful in raising Discussion: School closure is just one recognizes and understands that school student achievement, remained in of four school intervention models from school improvement status under which an LEA may choose to turn closures, by definition, displace section 1116 of the ESEA. around or close its persistently lowest- students and disrupt communities and Discussion: An existing charter school achieving schools, and the Department are among the most difficult decisions that is raising student achievement recognizes that it may not be faced by local authorities. However, would be unlikely, under the appropriate or workable in all each of the four school intervention requirements for identifying a State’s circumstances. To clarify this, we have models is predicated on the potentially persistently lowest-achieving schools, to revised the definition of school closure positive impact of ‘‘disruptive change’’ be identified for school intervention, in this notice to clarify that this option on student educational opportunities, because those requirements include not is viable when there are re-enrollment achievement, and other related only low levels of achievement, but also options in higher-achieving schools in outcomes. Schools targeted for closure making little or no progress on the LEA that are within reasonable under this notice will likely have served improving those low levels of proximity to the closed school that can their communities poorly for many achievement in recent years. Moreover, accommodate the students from the years, if not decades, as measured by this notice, as did the SIG NPR, closed school. To make this option more such factors as student achievement, provides flexibility for a school, such as viable, we have changed ‘‘high- graduation rates, and college enrollment a recently converted charter school that achieving schools’’ to ‘‘higher-achieving rates. Moreover, such schools also will meets the requirements of the restart schools.’’ likely have proven impervious to model, to use SIG funds to continue or Changes: We have included the positive change despite years of complete reforms it began within the following clarifying language in the identification for improvement, prior two years. On the other hand, it is definition of school closure: ‘‘School corrective action, or restructuring under possible, and in some cases appropriate, closure occurs when an LEA closes a the ESEA as well as other previous for an LEA to close a charter school that school and enrolls the students who reform efforts. The Department believes is not serving its students well and attended that school in other schools in that, when such schools prove implement a new intervention model in the LEA that are higher achieving. These unwilling or unable to change, closure the school. other schools should be within must be considered. Many communities Changes: None. reasonable proximity to the closed have experience in closing, school and may include, but are not consolidating, or otherwise changing the School Closure limited to, charter schools or new structure of their existing schools and Comment: A number of commenters schools for which achievement data are have their own processes and expressed their general views regarding not yet available.’’ procedures for obtaining public input whether closing schools is an Comment: A number of commenters and approval for such changes, appropriate intervention for raising expressed the opinion that a school including assessment of the impact on student achievement. Although no should never be closed if that option students, families, neighborhoods, other commenter advocated extensive use of displaces students and disrupts schools, and transportation this intervention, several acknowledged communities. The commenters noted requirements, as well as for developing that school closure is sometimes the importance of having a plans to facilitate smooth transitions for necessary, particularly for schools with neighborhood school that serves as the everyone involved. Although the a long history of very low achievement, cornerstone of a community. One Department encourages LEAs and SEAs and noted that some States and LEAs commenter noted that, when students to involve students, parents, educators, have used this strategy successfully. are moved to a school in a new the community, and other stakeholders
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in the process, we decline to add any Discussion: SIG funds are intended to school in other schools in the LEA that additional requirements in this area of provide support to LEAs for school are higher achieving. We have also appropriate local discretion. improvement efforts targeted primarily added clarifying language that such To address the disruptiveness school at the persistently lowest-achieving schools may be new schools for which closure may cause to a community, we schools in a State, and not at providing achievement data are not available. have modified the definition of school incentives for the creation of new Comment: Several commenters closure, as noted in response to the prior schools, charter or otherwise, that serve questioned how SIG funds may be used comment, to clarify that closure should the same general attendance area. in closing a school. One commenter entail re-enrolling students from the However, the restart model (as defined noted the importance of gaining closed school in other schools in the in this notice) may be used by LEAs in community input and that the costs for LEA that are within reasonable situations where the goal is to replace a closing a school may include costs proximity to the closed school. Finally, persistently lowest-achieving school associated with conducting parent and we note that school closure is just one with a charter school. community meetings. Another of the four school intervention models Changes: None. commenter recommended that available under the terms of this notice. Comment: One commenter suggested allowable costs include academic LEAs and communities that wish to that, in highlighting which schools may supports for struggling students who are preserve a neighborhood school may do be available to enroll students from a enrolled in new schools. so by implementing a turnaround, closed school, the Department Discussion: LEAs may use SIG funds restart, or transformation model. specifically mention magnet schools to pay reasonable and necessary costs Changes: None. along with charter schools. related to closing a persistently lowest- Comment: Several commenters Discussion: Decisions about the achieving school, including the costs recommended that a school not be schools to which students from closed associated with parent and community closed unless an LEA opens a new schools may transfer are best left to the outreach. However, SIG funds may not school in its place. One commenter LEAs selecting the school closure be used to serve students, struggling or specifically suggested closing a school option. The language in the definition of otherwise, in the schools to which they in phases and reopening it as a new school closure, as in the SIG NPR, transfer, unless those schools are Title I school. Under this concept, an LEA specifically mentions charter schools schools. The Department will include would permit both students and staff only because not all available charter additional examples of permissible uses who choose to do so to remain in the schools might be operated by the LEA of SIG funds in closing a school in school but the school would enroll no that is closing a neighborhood public guidance accompanying the application new students. At the same time, school and, thus, might not be initially package for SIG funds. according to the commenter, other included in an LEA’s plan for Changes: None. schools would be better prepared to transferring students from the closed absorb students who wish to transfer, school. This is not a concern for magnet Transformation Model logistical and facility issues would be schools and, thus, the Department General Comments minimized, and the new school would declines to make the requested change. have adequate time to recruit and train Changes: None. Comment: Many commenters high-quality staff and develop its Comment: One commenter expressed strong support for the instructional program. recommended that the Department transformation model. One commenter, Discussion: The Department has require that, before an LEA may enroll for example, described it as ‘‘a balanced, revised the language in the definition of students from a closed school in another comprehensive approach,’’ and another school closure to recognize the need to school, the LEA require a prospective described it as ‘‘a supportive and have available options for receiving school, including a charter constructive approach.’’ Still another accommodating the educational needs school, to demonstrate a record of commenter stated that it ‘‘provides the of the students in a closed school, but effectiveness in educating its existing greatest hope for promoting genuine does not believe it is necessary to students and the capacity to integrate school improvement.’’ Several require an LEA to open a new school in and educate new students from closed commenters noted that the place of the closed school. Many LEAs schools. The commenter emphasized transformation model would be, in participating in the SIG program have the importance of this latter point, reality, the only choice among the four under-utilized or under-enrolled noting that merely because a school is proposed interventions, especially for schools that may readily accommodate high-achieving does not mean that it is many rural school districts. students from a closed school; requiring equipped to help additional students A few commenters responded that the such LEAs to open new schools simply from the lowest-achieving schools transformation model would still not does not make sense. However, an LEA succeed while maintaining the quality enable some communities, particularly that chooses to reopen a new school of its current educational program. those with difficult demographics, to would be free to do so, either on its own Discussion: The Department believes make adequate yearly progress. Other or as part of a turnaround or restart that the requirement to enroll students commenters worried that, if not model. from a closed school in a higher- monitored carefully, the transformation Changes: None. achieving school responds to the model would become like the ‘‘other’’ Comment: One commenter suggested concerns of this commenter. The restructuring option under section that the Department provide incentives Department believes that such higher- 1116(b)(8)(B)(v) of the ESEA, perceived for the development of successful achieving schools are likely in nearly all as the easiest (but least meaningful) way charter schools in the areas in which circumstances, to provide a better to intervene in a struggling school. One schools are closed. Specifically, the education for any new students than of these commenters recommended commenter recommended that the was available in the closed school. adding strong language to make clear Department require that an LEA that Changes: We have added language to that the transformation model is not an partners with a CMO in order to serve the definition of school closure incremental approach and that, except the area in which the LEA is closing clarifying that school closure entails re- in the area of changing staff, the model schools receive a priority for SIG funds. enrolling students from the closed is as rigorous as the turnaround model.
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Discussion: We appreciate the persistently lowest-achieving school the transformation model is a factor that commenters’ support. We believe the may apply to the SEA to implement an an SEA must consider in evaluating the transformation model holds tremendous intervention in just some of those LEA’s application for SIG funds. promise for reforming persistently schools. Changes: None. lowest-achieving schools by developing Changes: None. Comment: One commenter Developing and Increasing Teacher and and increasing teacher and school School Leader Effectiveness leader effectiveness, implementing recommended adding ‘‘graduation comprehensive instructional reform rates,’’ rated equally with test scores, to Comment: A number of commenters strategies, increasing learning time and assess student achievement in supported the emphasis in the creating community-oriented schools, evaluating staff, ensuring that a school’s transformation model on strong and providing operating flexibility and curriculum is implemented with principals and teachers, noting that they sustained support. Assuming the fidelity, and providing operating are critical to transforming a low- activities that support these components flexibility. The commenter also achieving school. Commenters cited are implemented with fidelity, the recommended making increasing specific provisions that they supported, transformation model represents a graduation rates a required activity. such as ongoing, high-quality job- rigorous and wholesale approach to Discussion: We agree with the embedded professional development; reforming a struggling school, unlike the commenter that increasing high-school strategies to recruit, place, and retain manner in which the ‘‘other’’ graduation rates is vital to improving effective staff; increasing rigor through, restructuring option in section 1116 of student achievement, particularly in our for example, early-college high schools; the ESEA has often been implemented. Nation’s ‘‘dropout factories.’’ We are, extending learning time; emphasizing Changes: To strengthen the accordingly, adding increasing high community-oriented schools; increased transformation model, we have made a school graduation rates in three operating flexibility; and sustained number of changes that we discuss in provisions of the transformation model support from the LEA and SEA. the following paragraphs in our to make clear that it is also a goal of the Discussion: The Secretary appreciates responses to specific comments. interventions in this notice. We are also the commenters’ support. Comment: One commenter making a corresponding change in the Changes: None. recommended affording greater turnaround model. In addition, we are Comment: One commenter suggested flexibility to LEAs in implementing the defining ‘‘persistently lowest-achieving adding the word ‘‘ensuring’’ in the transformation model by allowing them schools’’ to include high schools that heading of the component of the to choose which activities are have had a graduation rate below 60 transformation model that requires ‘‘required’’ and which are ‘‘permissible’’ percent over a number of years. Through developing teacher and school leader within the four components. The these changes, we hope to identify high effectiveness. Another suggested commenter noted that LEAs with schools with low graduation rates that changing the heading to ‘‘providing persistently lowest-achieving schools would implement one of the teachers and school leaders with the may not have the teacher or leader interventions in this notice. resources and tools needed to be capacity or system to support, monitor, Changes: We have added increasing effective.’’ and sustain reforms across all of their high school graduation rates in three Discussion: We decline to make these schools. The commenter advocated for provisions of the transformation model: changes. First, we do not believe that a creating systems at the district level that Paragraphs (d)(1)(i)(B)(1); (d)(1)(i)(C); school can ensure teacher and school enable LEAs to provide support at each and (d)(4)(i)(A). We also made a leader effectiveness. We do believe, school. corresponding change to the turnaround however, that a school can take steps to Discussion: We decline to make the model in paragraph (a)(1)(i). In addition, improve teacher and leader requested changes. We have carefully we have included high schools that effectiveness. Second, we note that reviewed the required activities within have had a graduation rate below 60 eligible schools in LEAs that receive SIG the four components of the percent over a number of years in the funds—all of which are among the transformation model and have definition of persistently lowest- lowest-achieving schools in a State— concluded that each is necessary to achieving schools. will have very large amounts of ensure the rigor and effectiveness of the Comment: One commenter resources to implement the model; therefore, we continue to require recommended that the Department transformation model or one of the other each one. An LEA, of course, may require an LEA to set up an school intervention models. implement any or all of the permissible organizational entity within the LEA to Accordingly, we do not believe lack of activities as well as other activities not be responsible and held accountable for resources will be a barrier for reforming described in this notice. rapid improvement in student the persistently lowest-achieving In anticipation of receiving achievement in schools implementing schools in a State. Moreover, there is a unprecedented amounts of SIG funds, the transformation model in order to significant requirement that an LEA SEAs and LEAs should begin now to ‘‘expedite the clearing of bureaucratic provide ongoing, high-quality, job- plan for how they can use those funds underbrush’’ that can impede the embedded professional development for most effectively by putting in place the model’s effectiveness. all staff in a school implementing the systems and conditions necessary to Discussion: Although nothing in this transformation model. Principals, support reform in their persistently notice would preclude an LEA from teachers, and school leaders, therefore, lowest-achieving schools. Despite the establishing an organizational entity should have sufficient support to do best preparation, however, we know responsible for ensuring rapid their jobs. that not every LEA with persistently improvement in student achievement in Changes: We have revised the heading lowest-achieving schools has the schools implementing the in paragraph (d)(1) to read: ‘‘Developing capacity to implement one of the four transformation model, we decline to and improving teacher and school interventions in this notice in each such require the establishment of such an leader effectiveness.’’ school. As indicated in the SIG NPR, entity. Evidence of an LEA’s Comment: Many commenters, many therefore, an LEA that lacks the capacity commitment to support its schools in of whom were principals or represented to implement an intervention in each carrying out the required elements of principals, opposed the requirement to
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replace the principal. A number of ongoing collections of professional to measure students’ ready retrieval of commenters commented that such a practice that reflect student knowledge and do not accurately decision should be made locally, based achievement and increased high-school attribute student learning to particular on local data and circumstances in graduation rates to evaluate principal lessons, pedagogical strategies, or individual schools, rather than being effectiveness. individual teachers. In addition, the mandated by the Federal Government. Changes: We have modified commenter noted that such assessments One commenter, although paragraph (d)(1)(i)(B)(1) regarding do not measure qualities like student acknowledging the importance of evaluation systems for teachers and motivation, intellectual readiness, effective school leadership, asserted that principals to require that those systems persistence, creativity, or the ability to a school’s underperformance should not take into account student growth data as apply knowledge and work productively necessarily be blamed on the principal. a significant factor as well as other with others. One commenter asserted The commenter cited other salient factors ‘‘such as multiple observation- that State assessments are generally of factors, such as whether the principal based assessments of performance and low quality and measure a narrow range has the authority needed to turn a ongoing collections of professional of student learning. The commenter also school around or whether the principal practice reflective of student noted that assessments do not is laying a foundation for improvements achievement and increased high-school acknowledge the contributions (or lack not yet reflected in test scores. One graduation rates.’’ thereof) of others, such as prior teachers, commenter suggested that a principal Comment: Several commenters cited towards student achievement. Two not be removed until the principal’s the shortage of principals, particularly commenters argued that State performance has been reviewed. Others in rural areas, as a reason to eliminate assessments do not provide information suggested that, rather than replacing the the requirement to remove the principal about the conditions in which learning principal immediately, the requirements in a school using the transformation occurs and over which a teacher has no permit an LEA to offer comprehensive model. One commenter suggested hiring control, such as class size, student support and leadership training for a ‘‘turnaround leader’’ or contracting demographics, or instructional school leaders and other staff to assist with an external lead partner instead of resources. One commenter asserted that them in making the significant changes replacing the principal. State assessments fail to capture needed to transform a school. Several Discussion: We refer readers to the academic growth with respect to commenters suggested removing the earlier section of these comments and students with disabilities. A number of principal unless the person commits to responses titled ‘‘Principal and Staff commenters proposed other academic and is held accountable for a Replacement’’ where we respond to and nonacademic measures for turnaround plan that requires, for public comments about the principal evaluating teachers and school leaders, example, working with a partner replacement requirement under the such as standards-based evaluations of management organization or other entity turnaround model. practice that include such criteria as Changes: None. skilled in turning around struggling observations of lesson preparation, schools. Another commenter suggested Comment: A number of commenters suggested that a principal who has been content, and delivery; innovation in permitting flexibility with respect to teaching practices; analyses of student removing the principal in cases recently hired to turn around a school should not be removed. work and other measures of student warranted by, for example, the size and learning, such as writing samples, geography of a school or LEA, the cause Discussion: The commenters might have overlooked the fact that proposed grades, goals in individualized of the academic failure, the specific education programs for students with solutions being sought, or other barriers section I.B.1 in the SIG NPR allowed schools that have ‘‘implemented, in disabilities, and ‘‘capstone’’ projects to removal. such as end-of-course research papers; Discussion: We refer readers to the whole or in part within the last two assessment of commitment and ability earlier section of these comments and years, an intervention that meets the to use feedback and data to learn and responses titled ‘‘Principal and Staff requirements of the turnaround, restart, improve practices; one-on-one teaching; Replacement’’ in which we respond to or transformation models’’ to ‘‘continue staff leadership and mentoring skills; similar public comments about the or complete the intervention being conflict resolution skills; crisis principal replacement requirement implemented.’’ Thus, a recently hired management experience; extra- under the turnaround model. principal who was hired to implement Changes: None. a school intervention model that meets curricular roles and contributions to a Comment: One commenter some or all of the elements of one of the school; and relationships with parents recommended a three-pronged approach interventions in this notice would not and the community. to defining principal effectiveness: have to be replaced for purposes of a Discussion: We respect and agree with evidence of improved student transformation model. We have retained the commenters’ concerns that student achievement; changes in the number this flexibility in this notice. achievement data alone should not be and percentage of teachers rated as Changes: None. used as the sole means to evaluate effective and highly effective; and Comment: Many commenters reacted teachers and principals. We must assessment of a principal’s highest to the requirement in the SIG NPR to develop and support better measures priority actions and practices. use evaluations that are based in that take into account student Discussion: Generally, the Department significant measure on student growth achievement and more accurately agrees that multiple measures, including to improve teachers’ and school leaders’ measure teacher and principal the use of student achievement data, performance. A few commenters performance. Accordingly, we have should be used to evaluate principal supported the requirement; most revised the transformation model’s effectiveness. Accordingly, we have opposed it for a number of reasons. evaluation systems provision to require revised proposed section I.A.2.d.i.A.1 in Many commenters objected specifically that these systems take into account the SIG NPR (new paragraph to assessing teacher effectiveness using student growth data as a significant (d)(1)(i)(B)(1) to allow an LEA to use, in testing instruments not designed for that factor, but also include other factors addition to data on student growth, purpose. One commenter noted that ‘‘such as multiple observation-based observation-based assessments and standardized assessments are designed assessments of performance and
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ongoing collections of professional have increased student achievement and turnaround model. In addition, we note practice reflective of student graduation rates. One way of meeting that no LEA is required to apply for a achievement and increased high-school this requirement would be through School Improvement Grant. Those that graduation rates.’’ We have also clarified performance pay. An LEA has the do will receive significant resources to that those systems must be rigorous, flexibility to devise other means that support their efforts to reform their most transparent, and equitable and that they meet this requirement. struggling schools, but they also must must be designed and developed with Changes: None. have the ability to implement the teacher and principal involvement. Comment: One commenter, required components of whichever Nonetheless, it is important to note responding to the proposed requirement intervention they choose. Accordingly, that the Secretary believes that student to remove staff who fail to contribute to we decline to make the recommended achievement data must be included as a raising student achievement, changes. significant factor in evaluations of recommended that this provision be Changes: None. teacher and principal effectiveness. We deleted. The commenter noted that this Comment: A number of commenters are confident that the legitimate provision would make it very difficult provided additional examples of what concerns of the commenters regarding to attract the most highly qualified professional development of staff under use of student data can be addressed. teachers and principals to the the transformation model should entail, Changes: We have modified persistently lowest-achieving schools. such as: addressing the needs of paragraph (d)(1)(i)(B) regarding The commenter suggested that extensive students with disabilities and limited evaluation systems for teachers and professional development, rather than English proficient students; creating principals in several respects. First, we removal, be required for staff in schools professional learning communities modified paragraph (d)(1)(i)(B) to in which achievement does not within a school; providing mentoring; require that evaluation systems be improve. involving parents in their child’s rigorous, transparent, and equitable. Discussion: In general, we refer education, especially parents of limited Second, we modified paragraph readers to the section of these comments English proficient students and (d)(1)(i)(B)(1) to require that those and responses titled ‘‘Principal and Staff immigrant children; understanding and systems take into account student Replacement’’ where we respond to using data and assessments to improve growth data as a significant factor but similar comments regarding removal of and personalize classroom practice; and also include other factors ‘‘such as the staff replacement requirement under implementing adolescent literacy and multiple observation-based assessments the turnaround model. mathematics initiatives. of performance and ongoing collections Changes: We have modified Discussion: We appreciate the many of professional practice reflective of paragraph (d)(1)(i)(C) regarding excellent suggestions for additional student achievement and increased high removing staff who, in implementing a areas on which professional school graduation rates.’’ Third, we transformation model, have not development should focus. With one added paragraph (d)(1)(i)(B)(2) to contributed to increased student exception, we decline to add examples. require that evaluation systems be achievement and high school graduation We could never list all relevant topics designed and developed with teacher rates to make clear that removal should for strong professional development, and principal involvement. only occur after an individual has had which must be tailored to the needs of Comment: A number of commenters multiple opportunities to improve his or staff in particular schools, and we raised issues related to collective her professional practice and has still would not want to suggest that topics bargaining and the transformation not contributed to increased student not listed were, thus, less worthy of model. Several commenters objected to achievement and increased high school addressing. the perceived requirement to establish a graduation rates. Changes: We have added a performance pay plan based on student Comment: Several commenters permissible activity in paragraph outcomes, noting that collective objected to the Secretary’s proposal to (d)(2)(ii)(C) under ‘‘comprehensive bargaining agreements and, in some require an LEA to make ‘‘high-stakes’’ instructional reform strategies’’ to cases, State laws often prohibit such a tenure and compensation decisions highlight the need for additional plan. Two others noted that, because through which the LEA would ‘‘identify supports and professional development union contracts limit a principal’s and reward school leaders, teachers, and for teachers and principals in control over staffing, principals should other staff who improve student implementing effective strategies to not be held accountable for school achievement outcomes and identify and educate students with disabilities in the performance results. At least one remove those who do not.’’ The least restrictive environment and to commenter expressed concern that these commenters thought this standard was ensure that limited English proficient collective bargaining barriers could too imprecise. They noted that teacher students acquire language skills preclude implementation of the compensation, tenure, and dismissal necessary to master academic content. transformation model. are, for the most part, governed by State Comment: One commenter noted that Discussion: In general, we refer laws and/or collective bargaining the requirement to provide staff with readers to the earlier section of these agreements that cannot be simply ongoing, high-quality, job-embedded comments and responses titled overturned by a Federal grant program. professional development was silent ‘‘Principal and Staff Replacement’’ One of the commenters suggested that with respect to the impact of where we respond to similar public this provision be modified by adding, at professional development on comments regarding collective the end, the phrase ‘‘in full accordance instruction. The commenter pointed to bargaining as it relates to the turnaround with local and State laws, including an apparent inconsistency with the model. In addition, we note that the collective bargaining agreements.’’ emphasis in the permissible activity that transformation model does not require Discussion: In general, we refer suggested that LEAs be required to that an LEA establish a performance pay readers to the section of these comments institute a system for measuring changes plan for teachers or principals. Rather, and responses titled ‘‘Principal and Staff in instructional practices resulting from an LEA must identify and reward school Replacement’’ where we respond to professional development. Because the leaders, teachers, and other staff who, in similar comments regarding collective commenter values professional implementing the transformation model, bargaining issues as they relate to the development designed to improve
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instruction, the commenter suggests, that staff are well equipped to memoranda of understanding, or other recommended that the Secretary require facilitate family and community agreements between employees and a school to have a system for measuring involvement. We do not believe, their employers. changes in instructional practices however, that we should try to expressly Discussion: Like several commenters, resulting from professional development highlight each and every appropriate the Secretary supports and encourages in order to evaluate its efficacy. topic of high-quality professional the use of mutual consent. The Discussion: We believe that the development in this notice. Secretary considers mutual consent to requirement to provide ongoing, high- Changes: None. be a positive example of LEAs quality, job-embedded professional Comment: One commenter suggested partnering with unions to bring change development to staff in a school is that financial incentives are not to the Nation’s persistently lowest- clearly tied to improving instruction in necessarily the most motivating factor in achieving schools. That said, we decline multiple ways. First, the requirement retaining high-quality staff. Rather, the to require mutual consent as a part of that professional development be ‘‘job- commenter stated that the culture of a the transformation model because embedded’’ connotes a direct school—i.e., quality relationships with mutual consent policies and other connection between a teacher’s work in other teachers, the school climate, the similar agreements are best resolved at the classroom and the professional leadership of the principal, and the the State and local levels in the context development the teacher receives. potential for professional growth—is of existing collective bargaining Second, the examples of topics for often a greater motivator. agreements. professional development, such as Discussion: We agree that financial Changes: None. subject-specific pedagogy and incentives are not the only motivating Comment: One commenter differentiated instruction, are directly factor in attracting staff to a school or recommended that the Secretary add a related to improving the instruction a retaining them in the school. We hope requirement that, in the event budget teacher provides. Third, professional that changes in the culture of a school cuts occur, a principal be allowed to lay development must be aligned with the that result from implementing the off teachers on the basis of performance school’s comprehensive instructional interventions established in this notice rather than seniority. The commenter program. Finally, the articulated play a large role in attracting, placing, noted that this provision could be an purpose of professional development in and retaining high-quality staff. As a important lever for obtaining positive paragraph (d)(1)(i)(D) of the result, in both the transformation and changes to collective bargaining transformation model is to ensure that a turnaround models, we have provided agreements that would help low- teacher is ‘‘equipped to facilitate examples of several strategies to recruit, achieving schools attract and retain effective teaching and learning’’ and has place, and retain high-quality staff. effective staff. the ‘‘capacity to successfully implement Changes: We have added examples of Discussion: We decline to make the school reform strategies.’’ Although we strategies designed to recruit, place, and suggested change. Although we support believe that instituting a system for retain staff, including ‘‘financial the need to modify collective bargaining measuring changes in instructional incentives, increased opportunities for agreements if they impede efforts to practices resulting from professional promotion and career growth, and more attract and retain qualified staff in the development can be valuable, we flexible work conditions’’ in paragraphs persistently lowest-achieving schools, decline to require it as part of this (d)(1)(i)(E), with respect to the we do not believe we can or should program. We believe that the specificity transformation model, and (a)(1)(iii), prescribe the specific terms of those in the nature of the professional with respect to the turnaround model. agreements. development required for a We have also made clear that those Changes: None. transformation model is sufficient to strategies must be designed to recruit, place, and retain staff who have the Comprehensive Instructional Reform ensure that it, in fact, results in Strategies improved instruction. skills necessary to meet the needs of the Changes: None. students in the schools implementing a Comment: Several commenters Comment: One commenter transformation or turnaround model, suggested that the Department revise the recommended that the Department add respectively. comprehensive instructional reform a requirement that professional Comment: Several commenters component of the transformation model development be designed to ensure that supported the concept of ‘‘mutual by modifying or expanding the staff of a school using the consent’’—that is, ensuring that a school provision requiring the use of transformation model can work is not required to accept a teacher individualized student data to inform effectively with families and community without the mutual consent of the and differentiate instruction. One partners. The commenter reasoned that, teacher and the principal, regardless of commenter suggested clarifying that given the emphasis on working with the teacher’s seniority. One commenter individualized student data are to be families and community partners to recommended making ‘‘mutual used to meet students’ academic needs improve the academic achievement of consent’’ a required component of both while another commenter suggested students in a school, staff must know the turnaround model and the clarifying that the data should be used how to work with them. transformation model. Other to address the needs of ‘‘individual’’ Discussion: We decline to make the commenters, however, opposed any students. Other commenters suggested suggested change. We agree with the mention of ‘‘mutual consent,’’ even as a expanding this provision to include commenter that family and community permissible activity. One asserted that non-academic data such as chronic involvement in a school is critical to the the concept conflicts with the provision absenteeism, truancy, health (vision, school’s ultimate success and have in section 1116(d) of the ESEA that hearing, dental, and access to primary included, as both required and precludes interventions in Title I care), safety, family engagement and permissible activities, a variety of schools from affecting the rights, well-being, and housing. The provisions to address this important remedies, and procedures afforded commenter suggested that these data be need. We would expect professional school employees under Federal, State, used, in partnership with parents and development to include appropriate or local laws or under the terms of other community partners, to address training to ensure, as the commenter collective bargaining agreements, other student needs.
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Discussion: The purpose of this Accordingly, we are modifying the model as necessary to address other section of the transformation model is to notice to address this need. We also factors needed to respond to the specific improve instruction, and we agree that hope that an LEA’s extension or needs of students in the school. adding the word ‘‘academic’’ is a restructuring of the school day to add Changes: We have included in this helpful clarification. Although we also time for strategies such as advisory notice a definition of increased learning agree that non-academic data can play periods to build relationships between time that would permit many, if not all, an important role in identifying other students, faculty, and other staff will of the commenters’ suggestions. For student needs that can affect learning, help to identify students who are example, that definition makes clear local school administrators, working struggling and to secure for them the that a school may increase time to teach with parents and community partners, necessary supports sufficiently early to core academic subjects, including, for are in the best position to determine prevent their dropping out of school. example, civics and foreign languages, how to address those needs. Therefore, Finally, as noted earlier, we have added and to provide enrichment activities we decline to add a requirement that a references to increased high school such as service learning and school examine non-academic data. graduation rates in four provisions to experiential and work-based learning Changes: We have added the word make clear that implementation of the opportunities. ‘‘academic’’ in paragraph (d)(2)(i)(B) to models in high schools must focus on Comment: One commenter clarify that the continuous use of increasing graduation rates as well as recommended that the Department add student data to inform and differentiate improved student achievement. the implementation of technology-based instruction must be promoted to meet Changes: We have modified solutions to the list of permissible the academic needs of individual paragraph (d)(2)(ii)(E)(3) to add re- activities, while another commenter students. We made a corresponding engagement strategies as an example of recommended that the Department add change in paragraph (a)(1)(vii) regarding a way to increase high school online instructional services offered by the turnaround model. graduation rates. We have also added a for-profit or non-profit entity as an Comment: One commenter noted that paragraph (d)(2)(ii)(E)(4) suggesting that example of a comprehensive, research- requiring instructional programs to be permissible comprehensive based instructional program. ‘‘evidence-based’’ instead of ‘‘research- instructional reform strategies may Discussion: The Secretary agrees that based’’ would enable the use of include establishing early-warning technology can be an important tool for programs for which there is systems to identify students who may be supporting instruction, and we are accumulated evidence that does not at risk of failing to achieve to high adding as a permissible activity the meet the current ESEA definition of standards or graduate. suggestion to use and integrate ‘‘scientifically based research.’’ Comment: A number of commenters technology-based supports and Discussion: We agree with the suggested that the Department include interventions as part of a school’s commenter that an LEA should only additional required or permissible instructional program. Although online implement instructional programs for activities for carrying out instructional programs might be part of which there is a sufficient body of comprehensive instructional reform a school’s system of technology-based evidence supporting improved student strategies. Specifically, two commenters supports, we decline to mention it achievement. We do not believe a recommended that the Department specifically. Online instructional change is necessary, however, because require schools to conduct periodic programs, if research-based, are one of we do not use the term ‘‘scientifically reviews so as to ensure that the many ways to meet the needs of based research’’ and, therefore, do not curriculum is being implemented with students in struggling schools, invoke the stringent requirements in fidelity (rather than merely permitting particularly to provide courses or section 9101(37) of the ESEA. this activity) and improve school library programs that schools in rural or remote Changes: None. programs. Other commenters suggested areas cannot otherwise provide. We Comment: One commenter expanding the permissible activities in cannot mention in this notice, however, recommended that the Department add secondary schools to include learning each and every type of instructional a provision that would require a school opportunities that reflect the context of program. to identify ‘‘off-track and out-of-school the community in which the school is Changes: We have added as a youth, through analysis and located, such as service learning, place- permissible activity in paragraph segmentation of student data,’’ and based education, and civic and (d)(2)(ii)(D) using and integrating develop and implement education environmental education. The technology-based supports and options to put them back on track to commenters also recommended interventions as part of a school’s graduate. The commenter stated that, clarifying that improving students’ instructional program. once students are off track to graduating transition from middle to high schools Comment: One commenter on time, their likelihood of graduating is should include family outreach and recommended that the Department add often as low as 20 percent. Moreover, in parent education. Another commenter to the transformation model the strategy the 2,000 high schools in the Nation suggested that the Department expand to reorganize the school with a new with four-year graduation rates of 60 the list of permissible activities in purpose and structure it as a magnet percent or less, up to 80 percent of ninth elementary schools to include providing school, a thematic school, or a school- graders are significantly behind in skills opportunities for students to attend community partnership. or credits. Several other commenters foreign language immersion programs. Discussion: We decline to include this suggested including stronger support for Discussion: The Secretary agrees that change in the transformation model, a re-enrolling youth who have left high there are any number of important model that uses the existing staff in a school as a critical part of increasing activities that would be appropriate to school and who would likely not have graduation rates. address in a transformation model. As the expertise to implement an Discussion: We agree that programs described in this notice, the instructional program with a whole new and strategies designed to re-engage transformation model, by necessity, purpose. youth who have dropped out of high focuses on several broad strategies. Changes: None. However, we have school without receiving a diploma are However, nothing precludes local clarified in paragraph (a)(2)(ii) that a necessary in increasing graduation rates. school leaders from expanding the turnaround model may include a new
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school model (e.g., themed, dual making them required. For example, oriented schools’’ will vary school by language academy). some commenters recommended school depending on student and expanding the required activities to community needs and resources. There Increasing Learning Time and Creating include a comprehensive guidance is nothing in the notice that would Community-Oriented Schools curriculum delivered by a school prevent local school leaders from Comment: Several commenters counselor who is certified by the State undertaking any of the strategies in the expressed support overall and for department of education; partnering definition the commenters proposed if various activities of the ‘‘Increasing with parents, faith-based and necessary to respond to the specific learning time and creating community- community-based organizations, and needs of students in the school. oriented schools’’ component of the others to provide comprehensive Changes: None. transformation model, including the student services; more time for social Comment: Some commenters references to school climate, and emotional learning; and improving suggested that the Department add internships, and community service. school climate. Another commenter ‘‘community-based organization’’ and Discussion: We appreciate the recommended requiring that the ‘‘workforce systems, specifically commenters’ support. We are including transformation model include the nonprofit and community-based some of these activities in the definition components of the Comprehensive organizations providing employment, of increased learning time that also School Reform Demonstration program. training, and education services to applies to the Stabilization Phase II and Other commenters suggested adding youth’’ to the list of entities with which Race to the Top programs, rather than references to high school study-abroad an LEA or school may choose to partner listing them as specific elements of the programs as an example of a student in providing enrichment activities ‘‘increasing learning time and creating enrichment activity and activities during extended learning time. community-oriented schools’’ designed to reduce out-of-school Discussion: In the SIG NPR, we listed component. They have no less suspensions and expulsions as a universities, businesses, and museums importance, however. strategy for addressing school climate. as examples of entities with which a Changes: We have included in the Discussion: As we noted earlier, we school could partner in providing notice a definition of increased learning agree that there are any number of enrichment activities during extended time that includes opportunities for important activities that would be learning time. In this final notice, we are enrichment activities for students, such appropriate to address in a instead including a definition of as service learning and community transformation model. As described in increased learning time that applies to service. this notice, the transformation model, the Stabilization Phase II, Race to the Comment: Several commenters by necessity, focuses on several broad Top, and SIG programs. That definition suggested that the Department highlight strategies. However, there is nothing to no longer includes examples of the importance of certain activities by prevent local school leaders from appropriate partnership entities, revising the heading of this component. expanding the model as necessary to because there may be any number of For example, one commenter suggesting address other factors needed to respond organizations or entities in a particular revising the heading to emphasize to the specific needs of students in the community that might be appropriate family involvement while another school. partners. commenter suggested revising it to Changes: None. Changes: In the definition of specifically reference students’ social Comment: One commenter suggested increased learning time, we have and emotional needs. A third that the Department define included the following: ‘‘(b) instruction commenter suggested expanding the ‘‘community-oriented schools’’ as in other subjects and enrichment title to include ‘‘using research-based schools that partner with community- activities that contribute to a well- methods to deliver comprehensive based organizations to provide rounded education, including, for services to students.’’ necessary services to students and example, physical education, service Discussion: We decline to make these families using research-based methods, learning, and experiential and work- changes. Although we embrace the need which might include: a school-based, based learning opportunities that are to address not just the academic needs on-site coordinator; comprehensive provided by partnering, as appropriate, of students but also how their social and school- and student-level needs with other organizations.’’ emotional needs affect their learning assessments; community-assets Comment: One commenter suggested and to emphasize the importance of assessments and identification of that the reference to ‘‘parents,’’ in the family involvement, we believe it is potential partners; annual plans for list of entities with which schools might preferable to keep the heading for this school-level prevention and individual partner to create safe school component more general. The headings intervention strategies; delivery of an environments that meet students’ social, for each of the components in the appropriate mix of prevention and emotional, and health needs, should transformation model are deliberately intervention services; data collection include ‘‘parent organizations.’’ broad so as to cover a number of and evaluation over time, with on-going Discussion: We agree with this important activities, and the fact that a modifications of services; and/or other suggestion and are adding a reference to specific activity is not in a heading is research-based components. Another parent organizations. not a reflection of that activity’s commenter suggested removing the Changes: We have revised the importance. We believe the list of word ‘‘oriented’’ and using the term permissible activity in paragraph permissible activities illustrates various ‘‘community-schools,’’ which the (d)(3)(ii)(A) regarding creating safe ways in which a school can address commenter indicated is more commonly school environments to include a students’ social and emotional needs known. reference to partnering with parents and and involve families in their child’s Discussion: Although we appreciate ‘‘parent organizations,’’ along with faith- education. the commenters’ interest in ensuring and community-based organizations, Changes: None. greater clarity on the concept of health clinics, other State and local Comment: Several commenters ‘‘community-oriented schools,’’ we agencies, and others. suggested that the Department highlight decline to make the suggested changes. Comment: One commenter the importance of certain activities by The components of ‘‘community- recommended that the Department
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define ‘‘family engagement’’ and longer school day, week, or year a school implementing the requiring the use of certain family- schedule to significantly increase the transformation model would have a engagement mechanisms, including total number of school hours to include plan without the need for the family-engagement coordinators at additional time for instruction in core Department to require it. school sites, home visitation programs, academic subjects; time for instruction Changes: None. family literacy programs, and parent in other subjects and enrichment Comment: One commenter leadership programs. Another activities that contribute to a well- recommended that the list of potential commenter recommended defining rounded education; and time for technical assistance providers in ‘‘community engagement’’ as systemic teachers to collaborate, plan, and engage proposed section I.A.d.iv.A.2 of the SIG efforts to involve parents, community in professional development within and NPR be expanded to include residents, members of school across grades and subjects. ‘‘professional organizations that have a communities, community partners, and Changes: We have revised the notice track record of turning around low- other stakeholders in exploring student to define increased learning time. The performing schools.’’ and school needs and, working together, full definition is as follows: Discussion: This provision is intended developing a plan to address those Increased learning time means using to ensure that schools implementing the needs. a longer school day, week, or year transformation model receive Discussion: We agree that there are schedule to significantly increase the coordinated ongoing technical any number of important activities that total number of school hours to include assistance and reflects the belief that an could support increased family and additional time for (a) instruction in SEA, LEA, or external lead partner core academic subjects including community engagement. The reference organization would be in the best English; reading or language arts; to family and community engagement in position to integrate services at the mathematics; science; foreign languages; this notice is deliberately broad so as to school level. This notice does not civics and government; economics; arts; provide maximum flexibility in preclude the involvement of entities history; and geography; (b) instruction determining how best to address local other than those mentioned so long as in other subjects and enrichment needs. However, there is nothing to they fulfill the role of a lead partner in activities that contribute to a well- prevent local school leaders from integrating services and supports for the rounded education, including, for incorporating any of the strategies school. mentioned or other strategies that will example, physical education, service Changes: None. lead to effective family and community learning, and experiential and work- Comment: One commenter cautioned engagement. based learning opportunities that are Changes: None. provided by partnering, as appropriate, about the use of ‘‘weighted per-pupil Comment: One commenter with other organizations; and (c) school-based budgeting,’’ noting that recommended that the Department teachers to collaborate, plan, and engage early research indicates this practice include language to make clear that in professional development within and undermines cross-school cooperation by extending learning time can be across grades and subjects.8 promoting competition among schools accomplished by adding a preschool for students and the resources or Providing Operating Flexibility and program prior to school entry. liabilities they may represent. Discussion: The Secretary agrees that Sustained Support Discussion: We note that preschool education is very important Comment: One commenter suggested implementing a per-pupil school-based in ensuring that children enter that the Department add a requirement budget formula that is weighted based kindergarten with the skills necessary to that a school implementing the on student needs is listed as a succeed in school. He also agrees that transformation model be required to permissible, not required, activity to preschool education is an effective way present a plan for how the various give schools operational flexibility. We to increase learning time. elements of the model are aligned and believe allocating funds based on Changes: We have added, as a coordinated to improve student student characteristics and then giving permissible activity in paragraph achievement and other indicators of schools broad flexibility to use those (d)(3)(ii)(D), expanding the school student growth (such as health and civic funds to meet their respective needs is program to offer full-day kindergarten or competencies). one way to provide incentives for pre-kindergarten. Discussion: We decline to make the schools to use their cumulative Comment: Several commenters suggested change. We are confident that resources in innovative ways to meet suggested that the Department clarify the needs of their student population. If that increased learning time includes 8 Research supports the effectiveness of well- an LEA determines such budgeting is designed programs that expand learning time by a summer school, after-school programs, minimum of 300 hours per school year. (See not appropriate in the context of its and other instruction during non-school Frazier, Julie A.; Morrison, Frederick J. ‘‘The schools, it need not implement this hours. Several other commenters Influence of Extended-year Schooling on Growth of activity. suggested increasing instructional time Achievement and Perceived Competence in Early Changes: None. Elementary School.’’ Child Development. Vol. 69 during the school day and the need to (2), April 1998, pp. 495–497 and research done by F. General Selection Criteria make existing time more effective, Mass2020.) Extending learning into before- and including through the use of technology. after-school hours can be difficult to implement Comment: None. effectively, but is permissible under this definition Discussion: As part of an overall effort Another commenter suggested clarifying with encouragement to closely integrate and that extended learning time should be coordinate academic work between in-school and to reorganize and clarify the State beyond the current State-mandated out-of school. (See James-Burdumy, Susanne; Reform Conditions Criteria and State instructional time. Dynarski, Mark; Deke, John. ‘‘When Elementary Reform Plan Criteria in this notice, the Schools Stay Open Late: Results from The National Discussion: We have added in this Evaluation of the 21st Century Community Learning Department is creating a new section notice a definition of increased learning Centers Program.’’ http://www.mathematica- (F), which includes both new criteria time that applies to the Stabilization mpr.com/publications/ and criteria that were included in the _ Phase II, Race to the Top, and SIG redirect PubsDB.asp?strSite=http:// NPP under other sections. These epa.sagepub.com/cgi/content/abstract/29/4/296. programs. Under that definition, Educational Evaluation and Policy Analysis, Vol. 29 changes are described in greater detail increased learning time means using a (4), December 2007, Document No. PP07–121.) below.
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Changes: Criterion (F)(1)(i) years deserve recognition of this fact in that States should provide additional incorporated proposed criterion (E)(2) their Race to the Top applications. We resources, such as technical assistance on making education funding a priority. also believe that recent evidence of a and funding, to allow struggling schools New criterion (F)(1)(ii) examines the State’s commitment to adequately fund to implement school intervention extent to which a State’s policies lead to education is more important for models. equitable funding (a) between high-need evaluating its Race to the Top Discussion: We agree with the LEAs (as defined in this notice) and application than data from four or five principle that all students should other LEAs, and (b) within LEAs, years ago. benefit from at least similar levels of between high-poverty schools (as Section 14005(d)(1)(A) of the ARRA education resources regardless of where defined in this notice) and other sets forth a condition for receiving a they live or attend school. We are schools. Criterion (F)(2)(i) through (iv) formula award from the State Fiscal adding criterion (F)(1)(ii), which will incorporate the criteria regarding charter Stabilization Fund; this requirement examine the extent to which a State’s schools from proposed criterion (D)(2). does not apply to section 14006 of the policies lead to equitable funding (a) Criterion (F)(2)(v) is a new criterion that ARRA, which authorizes the Race to the between high-need LEAs and other will examine the extent to which a State Top program. Instead, criterion (F)(1)(i) LEAs, and (b) within LEAs, between enables LEAs to operate innovative, is consistent with the waiver for the high-poverty schools and other schools. autonomous public schools other than State Fiscal Stabilization Fund MOE Closer attention by States to funding charter schools. Criterion (F)(3) requirement, which the Secretary has equity will help ensure that high-need incorporates a revised version of already granted to a number of States. LEAs and high-poverty schools, which proposed criterion (E)(1)(iii). The two-year comparison used in are a particular focus of Race to the Top Selection Criterion (F)(1): Making criterion (F)(1)(i) reflects the plans, are receiving sufficient State and education funding a priority (Proposed Department’s understanding of the local educational resources to serve Selection Criterion (E)(2)) Funding and difficult choices that many States have their students. Also, developing and Facilities: been forced to make in the recent funding budgets that are sufficient in Comment: Many commenters objected economic recession, while at the same size and scope to successfully to criterion (F)(1)(i) (proposed (E)(2)), time recognizing that States that have implement school intervention models which will measure the extent to which made education funding a priority in in the persistently lowest-achieving the percentage of total State revenues such difficult budgetary times are better schools, including high-poverty and used to support education in FY 2009 positioned to successfully implement high-minority schools, will be a critical was greater than or equal to the their Race to the Top plans. element of State Race to the top plans, percentage in FY 2008. A number of Changes: None. in accordance with the statewide commenters stated that this one-year Comment: Some commenters capacity building criteria in section snapshot of education financing would suggested that the Department allow (A)(2) of this notice. Successful State examine too narrow a period of time, States to explain their education applicants and their participating LEAs thereby favoring wealthy States. Some expenditures in the context of their (as defined in this notice) will be able commenters, therefore, recommended overall economic situation. One to use State Fiscal Stabilization Fund looking at a minimum of five years of commenter requested clarification as to Phase Two, Race to the Top, and School financial data. Similarly, some what financial data the Department will Improvement Grant funding to ensure commenters argued that criterion look at when examining State support that all targeted schools have sufficient (F)(1)(i) should be consistent with the for education funding. resources to effectively implement ‘‘maintenance of effort’’ (MOE) Discussion: We believe that States’ selected school intervention models. requirement in section 14005(d)(1)(A) of responses to criterion (F)(1)(i) will be Changes: We have added criterion the ARRA, which requires States to judged most accurately and reliably if, (F)(1)(ii) to the final notice to consider assure in their State Fiscal Stabilization per the language in this notice, States the extent to which a State’s policies Fund applications that they will spend describe changes in education spending lead to equitable funding between high- at least as much on K–12 public in relation to changes in revenues need LEAs and other LEAs and, within education in fiscal years 2009, 2010, available to the State. This creates more LEAs, between high-poverty schools and 2011 as they did in fiscal year 2006. comparability between States than and other schools. One commenter recommended that the would be achieved by allowing States to Comment: None. minimum proposed evidence for explain their economic situations. Discussion: As stated earlier, in order criterion (F)(1)(i) include the extent to Changes: None. to reduce redundancy and the burden which State-level K–12 education Comment: Many commenters asserted on States, we are combining proposed capital financing as a percentage of total that it was important to consider criteria (E)(1)(i) and (E)(1)(ii) into one State capital financing has increased, whether States were meeting obligations criterion and designating it as criterion decreased, or remained the same in the to fund education adequately and (A)(3)(i). last five fiscal years. One commenter equitably. Two commenters emphasized Changes: Criterion (A)(3)(i) provides sought clarification that criterion the importance of funding equity for for an examination of the extent to (F)(1)(i) is not intended to prejudice schools implementing a school which a State has made progress over States that used State Fiscal intervention model, recommending that the past several years in each of the four Stabilization Funds to fill budget State plans include information on the education reform areas, and used its shortfalls. Other commenters stated that extent to which their lowest-performing ARRA and other Federal and State this criterion did not go far enough, schools receive equitable funding for funding to pursue such reforms. because if total State revenues fell, a operations and facilities as compared to Selection Criterion (F)(2): Ensuring State could earn points even if it was their highest-performing schools. successful conditions for high- cutting funding for education. Another commenter stated that funding performing charter schools and other Discussion: The Department believes adequacy and equity are especially innovative schools (Proposed Selection that States that have protected critical for high-need LEAs serving Criterion (D)(2)): education funding from concentrations of poor and minority Definitions: Comments regarding the disproportionate cuts over the past two students. Finally, one commenter added definitions of high-performing charter
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school and innovative, autonomous Department to include a definition of schools and charter school operators, we public schools are addressed, as ‘‘high-quality charter schools’’ in the are revising criterion (F)(2)(i) to refer to appropriate, below. final notice, with one stating that ‘‘high-performing charter schools’’ increasing the number of charter schools rather than charter schools. We also are Overall Charter School Comments makes sense only if charter schools are adding a definition of high-performing Comment: Many commenters held to a standard at least as high, if not charter school using language adapted supported criterion (F)(2) (proposed higher, than that of traditional public from the Department’s Public Charter criterion (D)(2)), which is intended to schools. School Program. At the same time, the increase the supply of high-performing Similarly, one commenter also Department believes that States should charter schools, including provisions to asserted that many regular public have flexibility in establishing charter remove limits on the numbers or schools demonstrate the creativity, school laws, and that, for the purposes enrollment of public charter schools in innovation, and continuous of the Race to the Top competition, such a State, efforts to strengthen the charter improvement claimed by the laws should be judged on the extent to school authorizing process, and proponents of charter schools. which they satisfy the criteria in this ensuring equitable funding both for the Discussion: The Department final notice, and not in relation to any regular operations of public charter appreciates the many comments in particular model for such laws. schools and for charter school facilities. support of the goal of increasing the Finally, we acknowledge that charter Two commenters urged the Department number of high-performing charter school operators do not have a to ensure that the definition of charter schools, both as a strategy to help turn monopoly on educational innovation schools in (F)(2) include virtual charter around the persistently lowest- (i.e., that charter schools are not a schools. There was, however, some achieving schools and to increase the ‘‘silver bullet’’ for school interventions), confusion about the potential impact of educational options for students and that many States, LEAs, and schools these criteria, with one commenter attending such schools. It is important have developed alternative education asserting that States that do not meet the to clarify, however, that criterion (F)(2) reform models that are demonstrating criteria should be ineligible for Race to was never intended to determine success in raising student achievement the Top grants and another urging the eligibility for Race to the Top grants; and turning around low-achieving Department to clarify that removing rather, this provision represented one schools. Consequently, we are adding ‘‘caps’’ on charter schools is not a pre- criterion by which a State that had taken new criterion (F)(2)(v) regarding the requisite for Race to the Top certain steps to increase the supply of extent to which States enable LEAs to participation. Other commenters high-performing charter schools could operate innovative and autonomous expressed concern that not meeting earn points in the Race to the Top public schools other than charter criterion (F)(2) would penalize the competition. The Secretary recognizes schools, and we are revising the title of students and schools in their States by that the available research on the this criterion to Ensuring Successful making them ineligible for a Race to the effectiveness of charter schools in Conditions for High-Performing Charter Top grant. Many other commenters raising student achievement is mixed, Schools and Other Innovative Schools. objected to the emphasis on charter that some State laws significantly limit We also are adding, as the evidence schools because of extensive research the creation or expansion of charter required for (F)(2)(v), a description of suggesting that many charter schools schools, that charter schools compete how the State has met this criterion. perform no better than regular public with the regular public schools for Finally, we are adding a definition of schools in raising student achievement. resources and teaching talent, and that innovative, autonomous public schools Other commenters objected to charter smaller communities, particularly in to give greater clarity to new criterion schools because, they said, most charter rural areas, may not have sufficient (F)(2)(v). schools ‘‘merely serve to drain the most resources and talent to support the Changes: We have incorporated the motivated parents and students from the creation of charter schools. However, criteria from proposed criterion (D)(2) existing district public schools’’ and the Secretary also believes that high- into criterion (F)(2), which has been give the appearance of an effort to performing charter schools can be an renamed ‘‘Ensuring Successful ‘‘privatize’’ public education. Several educational lifeline in communities Conditions for High-Performing Charter commenters argued that the emphasis with chronically low-achieving regular Schools and Other Innovative Schools.’’ on charter schools failed to respect State public schools. In such cases, charter We also have revised (F)(2)(i) to refer to authority in this area, noting that 11 schools, whether created through the ‘‘increasing the number of high- States do not have charter school laws, conversion of a regular public school performing charter schools’’ rather than citing one example where voters had enrolling the same students or by ‘‘increasing the number of charter rejected charter schools in multiple establishing a new school that provides schools,’’ as in proposed (D)(2)(i). We ballot initiatives, and suggesting that an alternative to the regular public have added a definition of high- resource limitations in rural States can schools, offer one of the most promising performing charter school and defined it make the creation of charter schools and proven options for breaking the to mean: ‘‘a charter school that has been difficult, if not impossible. One of these cycle of educational failure. The in operation for at least three commenters also suggested that States provisions in criterion (F)(2), taken as consecutive years and has demonstrated without charter school laws receive whole, are intended to reward States overall success, including (a) substantial credit for laws allowing similarly that have taken steps not just to progress in improving student innovative ‘‘charter-like’’ schools, facilitate the opening of new charter achievement (as defined in this notice); including virtual schools. Several schools (which may include virtual and (b) the management and leadership commenters urged the Department, in charter schools), but to set high necessary to overcome initial start-up examining State charter school laws standards for charter school operators, problems and establish a thriving, under criterion (F)(2), to ‘‘benchmark’’ provide them with an equitable share of financially viable charter school.’’ In those laws against the model State public funding for operations and addition, new criterion (F)(2)(v) rewards charter school law developed by the facilities, and hold them accountable for the extent to which ‘‘[t]he State enables National Alliance for Public Charter their performance. To support this LEAs to operate innovative, autonomous Schools. Two commenters asked the emphasis on high standards for charter public schools other than charter
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schools,’’ and we will require, as financial oversight, and the may be misplaced, as it could simply evidence for (F)(2)(v) described in implementation of effective evaluation mean that the authorizer lacked a Appendix A to this notice, a description systems. Another commenter rigorous approval process on the front- of how the State enables LEAs to recommended conditioning increases in end. This commenter called for States to operate innovative, autonomous public the number of charter schools on create a system for assessing the quality schools other than charter schools. leadership by a certified principal, of an authorizer’s initial review of Finally, we have added a definition of adoption of a ‘‘whole child’’ charter school applications, as part of an innovative, autonomous public schools instructional program, and the non- overall charter school authorizer review and defined it to mean: ‘‘open discriminatory enrollment of high-need and oversight process. Another enrollment public schools that, in return student populations. One commenter commenter recommended that the for increased accountability for student called for the final notice to require new Secretary consider the extent to which achievement (as defined in this notice), charter schools to use either a ‘‘model States evaluate authorizers in have the flexibility and authority to with a proven record of effectiveness or accordance with national standards for define their instructional models and a new model with an evidence-based quality authorizing. One commenter associated curriculum; select and strategy.’’ also warned against encouraging States replace staff; implement new structures Discussion: Our intention with to relax approval criteria in order to and formats for the school day or year; respect to criterion (F)(2)(i) was not to demonstrate a greater number of and control their budgets.’’ eliminate reasonable conditions approvals as evidence that they do not established by States for the approval of Charter School Caps ‘‘inhibit increasing the number of new charter schools, but to discourage charter schools in the State.’’ Finally, Comment: Many commenters objected arbitrary limitations that impede the one commenter claimed that charter to the language in criterion (F)(2)(i) educational innovation that can schools are more effective and because they believed it would require accompany the creation of new charter accountable when authorized by the the elimination of ‘‘caps’’ on the number schools or that prevent the expansion of LEA in which they operate, and urged of charter schools in a State. Some successful charter school models in a the Secretary to clarify in the final commenters claimed that decisions State. Moreover, while removing such notice that such locally authorized related to charter school caps, like other limitations would increase the number charter schools are preferable to charter charter school matters, should be left to of points that a State could earn under schools authorized by organizations the States and should not be a condition the criteria in (F), retaining those ‘‘outside the K–12 system.’’ for receipt of Race to the Top funds. limitations would not make a State Discussion: The Secretary agrees with Other commenters raised substantive ineligible for a Race to the Top award. the commenters that charter school objections to eliminating caps, arguing The Department agrees that States authorizers play a key role in promoting that limiting the number of charter should have the discretion to set their quality and accountability throughout schools in a State was essential to own requirements for new charter the charter school movement. He has maintaining accountability for charter schools, and that, contrary to the cited recent, disappointing research schools by ensuring that States had the suggestions of some commenters, from the Center for Research on capacity to oversee charter schools, prescribing the use of certain Education Outcomes at Stanford provide sufficient resources and educational methods or models would University on charter school technical assistance to new charter undermine the flexibility to innovate effectiveness in raising student schools, and protect the interests of that is the hallmark of high-performing achievement as ‘‘a wake-up call’’ for the students and parents. In this context, charter school operators. On the other charter school community, and has several commenters noted that recent hand, criterion (F)(2)(ii) is intended to called on charter school authorizers to research appeared to have highlighted reward States for strong authorizing set a higher bar for approval and do a an inverse relationship between the practices, including those related to the better job of holding charter schools number of charter schools in a State and approval and re-approval, monitoring accountable for performance.9 Criterion the quality of those charter schools. and accountability (including reporting (F)(2)(ii), which examines the extent to Other commenters sought clarification measurable outcomes), and closure of which a State has laws, statutes, of specific issues related to charter ineffective charter schools. regulations or guidelines on how charter school caps, such as whether a State Changes: None. authorizers approve, monitor, hold could meet criterion (F)(2)(i) if it had Charter School Authorizers accountable, reauthorize, and close ‘‘plenty of room’’ under its existing cap, charter schools, will help the if caps might be applied to new charter Comment: Many commenters Department determine which schools while permitting expansion by emphasized the importance of charter authorizers are responding to the proven charter school operators, or school authorizers in increasing the whether a cap that currently is not number of charter schools and the Secretary’s call. On the other hand, inhibiting charter school growth might effective use of the charter school model given the large number of charter school do so later at any point during the to turn around the persistently lowest- authorizers—roughly half of all charter lifetime of a Race to the Top grant. One achieving schools. Several commenters schools are authorized by individual commenter also recommended that the called for greater accountability for LEAs rather than statewide chartering final notice should focus on the charter school authorizers, including the organizations, as well as the need for measurable outcomes of charter schools collection of data on the performance of flexibility on the part of authorizers to rather than their numbers. Other charter schools in each State broken continue to support innovation and commenters urged that any lifting of down by authorizer and an explanation experimentation, the Department does charter school caps should be of the financial and educational not believe it would be appropriate to accompanied by stronger accountability obligations of charter school use the Race to the Top program to for charter schools, including authorizers. However, one commenter 9 ‘‘Multiple Choice: Charter School Performance compliance with conflict of interest and warned that the NPP’s focus on how in 16 States,’’ Center for Research on Education open meeting laws, accountability for many charter schools an authorizer has Outcomes (CREDO), Stanford University, 2009, student achievement, increased closed as an indicator of accountability http://credo.stanford.edu/.
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mandate any particular new standards each of the past five years, the number minimum proposed evidence for this or oversight for charter authorizers. of charter school applications approved, criterion, will effectively reward States Similarly, the Department declines to the number of charter school that have created the conditions for endorse one type of authorizer over applications denied, and reasons for the increasing the number of high- another. On the other hand, in denial (academic, financial, low performing charter schools. recognition of the fact that the financial enrollment, other). Changes: None. and management performance of charter Ensuring Charter School Quality Charter School Autonomy schools are important factors in authorizing and renewal decisions by Comment: Several commenters Comment: Many supporters of charter charter school authorizers, the recommended modifications to criterion schools stressed that they must have Department has revised criterion (F)(2). One commenter warned that autonomy to innovate while continuing (F)(2)(ii) to state that the use of student without a strong focus on quality, the to be exempt from State rules and achievement is ‘‘one significant factor, charter school option under a restart regulations governing the regular public among others,’’ in decision-making by model (referenced in criterion (E)(2)(ii) schools. Some of these commenters charter school authorizers. And in and described in detail in Appendix C) recommended adding a new criterion to recognition of the important role charter could undermine school intervention (F)(2) on the extent to which a State schools should serve in meeting the efforts by potentially creating a ensures that its charter schools have ‘‘a needs of all students, especially high- ‘‘loophole’’ under which a change in high degree of autonomy’’ over budgets, need students, we have added to the governance might mask the absence of programs, staffing, curriculum, use of criterion that authorizers should find substantive changes within a time, and general day-to-day operations. ways to ‘‘encourage charter schools that persistently lowest-performing school. Other commenters wrote of an serve student populations that are To avoid such outcomes, these ‘‘accountability gap’’ between charter similar to local district student commenters recommended that the schools and regular public schools, populations, especially relative to high- criteria in (F)(2) be revised to require the arguing that charter schools are not held need students.’’ use of charter school models with a to the same standards as regular public We also are revising the minimum demonstrated record of effectiveness, schools. One commenter recommended, evidence States should submit in add the specific components of for example, that criterion (F)(2)(ii) on response to this criterion. Appendix A successful charter schools, and reward charter school authorizers ensure that provides that such evidence should States that had increased the number of charter schools are held to the same include, among other items, for each of high-quality charter schools, in accountability requirements as the past five years: The number of particular those that serve at-risk traditional public schools. Another charter school applications made in the students. Another commenter commenter cited widespread allegations State; the number of charter school recommended an emphasis on charter of financial mismanagement related to applications approved; the number of schools as laboratories for the charter schools. One commenter also charter school applications denied, and development of best practices in such proposed collection of data on whether the reasons for the denials. This areas as offering rigorous college- and charter schools offer a similar range of additional data will support an career-preparation options. On the other activities as non-charter public schools, assessment of the rigor of a State’s hand, some commenters encouraged the such as physical education, recess, and approval process. We are not, however, Department to promote broader and science courses. requiring in this final notice that this more flexible approaches to charter Discussion: We agree that autonomy data be disaggregated by charter school school authorization, such as and flexibility to innovate are essential authorizer, primarily because the very encouraging statewide authorizers in characteristics of successful charter large number of LEA charter school States that currently allow only local schools. On the other hand, it is clear authorizers in many States would make school boards to approve charter that this autonomy must be such disaggregation overly burdensome. schools. accompanied by strong accountability Changes: We have revised (F)(2)(ii) to Discussion: The Department agrees for performance, and this is what the ‘‘require that student achievement (as with the overall emphasis of Department is emphasizing under defined in this notice) be one significant commenters on efforts to improve the criterion (F)(2)(ii), which addresses the factor, among others’’ that charter quality of charter schools; indeed this is role of charter school authorizers in school authorizers should take into a key goal of criterion (F)(2). However, approving, monitoring, holding account in approving, monitoring, we believe this goal is best accountable, reauthorizing, and closing holding accountable, reauthorizing, and accomplished through strengthening charter schools. One key aspect of this closing charter schools. We have State and local authorizing practices strong accountability for charter referenced ‘‘student achievement,’’ and ensuring equitable funding for authorizers will be the extent to which rather than the term ‘‘student academic charter schools, rather than by requiring student achievement plays a significant achievement’’ used in the NPP, to be the use of particular charter school role in their decisions to approve, re- consistent with the definition of student models or specifying the use of certain approve, or close charter schools. achievement included in this final components in newly created charter Striking the right balance between notice. We have also specified that schools. If charter schools are to autonomy and accountability is authorizers should ‘‘encourage charter continue to be ‘‘laboratories for the difficult, but the Department believes schools that serve student populations development of best practices,’’ as that recent evidence that too many that are similar to local district student proposed by one commenter, they need charter schools are not fulfilling their populations, especially relative to high- flexibility to innovate, not cookie-cutter promises to raise student achievement need students.’’ Finally, we have patterns to follow. The Department also demands a tilt toward stronger revised Appendix A to add to the declines to weigh in on the debate over accountability; consequently the minimum evidence required for State versus local chartering agencies, as Secretary declines to add a new evaluating a State’s performance against such issues are best determined by the criterion promoting charter school criterion (F)(2)(ii) the number of charter authorities involved. Finally, we believe autonomy. However, suggestions by school applications made in the State in that criterion (F)(2), together with the commenters that the Department
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examine the extent to which charter schools are public schools, and should buildings. Determining what is schools look and operate like regular be entitled to an equitable share of local, ‘‘equitable’’ in these circumstances may public schools appear to miss a key State, and Federal education dollars like be all but impossible. The Department purpose of the charter school other public schools. States have does not agree with the movement, which is to explore whether, developed funding systems that link recommendation that charter schools by operating differently from the regular funding for charter schools to student demonstrate sustainability before public schools, charter schools can characteristics, such as poverty or receiving facilities funding, since such a achieve better results, particularly for disability status, but the Department is policy would represent a ‘‘catch 22’’ those high-need students who for too not aware of any public education situation for many charter schools, long have been poorly served by the system that links funding to student which would have to demonstrate regular school system. achievement or parental involvement, sustainability before receiving facilities Changes: None. so evaluating States based on such funding, but often do not achieve Charter School Funding linkages would have no impact on sustainability until they have their own differentiating States for the purposes of facilities. Finally, the issue of Comment: Many commenters this competition. establishing a public ownership interest supported criterion (F)(2)(iii) (proposed Changes: Criterion (F)(2)(iii) now in publicly financed charter schools is criterion (D)(2)(iii)), which examines the reads, ‘‘The State’s charter schools a matter for State and local agencies that extent to which a State’s charter schools receive (as set forth in Appendix B) finance public charter schools. receive (as set forth in Appendix B) equitable funding compared to Changes: None. equitable funding compared to traditional public schools, and a Comment: One commenter expressed traditional public schools, and a commensurate share of local, State, and concern that criterion (F)(2)(iv) referred commensurate share of local, State, and Federal revenues.’’ to access to public facilities as an Federal revenues. Other commenters example of facilities supports States recommended that the Department Charter School Facilities Funding could provide to charter schools, clarify the meaning of the term Comment: Many commenters claiming that opening up space in ‘‘equitable funding’’ for charter schools. expressed support for charter school existing public schools to charter Several commenters also recommended facilities funding, which is the focus of schools has led to overcrowding and that the Department require States to criterion (F)(2)(iv) (proposed criterion larger class sizes. report on the amount of funding (D)(2)(iv)). Several commenters Discussion: There is nothing in provided for charter schools and charter recommended that the Department add criterion (F)(2)(iv) that would require school facilities in comparison to language to this criterion to clarify that any State to adopt charter school facility funding provided to traditional public credit enhancement funds should be access policies that lead to schools. Other commenters opposed included when accounting for charter overcrowding and larger class sizes. The providing public funds, including school facilities funding. Another intent of this criterion is simply to facilities funding, to charter schools. commenter recommended the addition ensure that States describe in their Race Some commenters suggested linking of language to criterion (F)(2)(iv) to to the Top applications whether charter funding for charter schools to student require States to distribute facilities schools have equitable access to funding achievement, student characteristics, funding in an equitable manner. Other for facilities and to available public and the grade levels being served by commenters recommended that charter facilities. Local authorities would have those particular schools, as well as schools be required to show discretion to make decisions about the parental involvement. sustainability before receiving facilities feasibility of non-charter schools and Discussion: The Department funding. One commenter suggested that charter schools sharing the same appreciates the comments in support of the public should retain ownership building, but this option is not required ensuring more equitable treatment of interest in facilities that it finances. to meet criterion (F)(2)(iv). charter schools, including the provision Discussion: The Department Changes: None. of equitable funding compared to understands that access to public traditional public schools. However, facilities or funding for facilities is one Charter School Metrics State and local funding systems, of the major challenges confronting Comment: A number of commenters particularly as they relate to charter charter school operators, and is proposed the collection of additional schools, are both complex and not committed to helping charter schools data and evidence related to the always comparable, making it difficult secure facilities funding. However, we evaluation of a State’s charter school to provide a universally applicable believe that criterion (F)(2)(iv) is policies and practices. Several definition of ‘‘equitable funding’’ for sufficient to permit the Department to commenters recommended that data charter schools or to develop and assess a State’s commitment to and collected on the number of schools implement appropriate and reliable progress in supporting fair access to closed by a State’s charter school reporting metrics. We are making minor facilities and funding for facilities by authorizers include a list of those that edits to criterion (F)(2)(iii) for the public charter schools, including access were closed due to academic reasons, purpose of clarification, and we believe to credit enhancement funds. As for the financial issues, low enrollment, or that the resulting language in the suggestion to add language on mismanagement. Other commenters criterion, the guidance to reviewers equitability to criterion (F)(2)(iv), it is recommended that the final notice provided in the Scoring Rubric in not clear how this term would be require States to provide the last five Appendix B, and the related minimum meaningfully defined given that charter years of State charter school funding evidence requirements are sufficient to schools typically obtain access to data so that the Department can assess a State’s progress in providing its facilities in markedly different ways examine the actual impact of State plans charter schools with a commensurate than the regular public schools, which and statutory requirements for funding share of local, State, and Federal benefit from a half-century of public charter schools. Several commenters revenues. We also do not agree with school construction, while charter proposed that States provide commenters who opposed public schools may share public space, rent information on the number of charter funding for charter schools. Charter private space, or buy their own school applications over the past five
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years, the number of charter schools potentially difficult to analyze, autonomous public schools. This approved and the number of students particularly since about half of charter change also recognizes the important attending those schools, and reasons for schools are authorized at the LEA and role of LEAs as incubators of new the denial of other applications. One not the State level. The Department does approaches to turning around low- commenter also suggested that the believe, however, that additional, more achieving schools. In addition, two States provide data comparing charter detailed information on the charter other criteria in section (F) provide an school performance with that of school application process would be opportunity for States to explain how traditional public schools with similar useful in measuring a State’s they have (a) created conditions demographic and other characteristics. performance under criterion (F)(2) favorable to education reform or Another commenter recommended without imposing significant additional innovation not described under other requiring States to post on their web burden on States and charter State Reform Conditions Criteria that sites aggregate data comparing the ESEA authorizers. For this reason, the final have improved student outcomes, or (b) improvement status of charter schools notice retains the required evidence set have plans or are implementing plans and regular public schools and to ensure forth in the NPP and adds to the for significant reforms not described that charter schools are audited in the required evidence the number of charter under other State Reform Plan Criteria same manner and with the same applications received in each of the past that are expected to contribute to frequency as regular public schools. five years, the number of applications improving important student outcomes. Discussion: The NPP proposed the approved and denied, and the reasons Changes: New criterion (F)(2)(v) gives a State credit for the extent to which it collection of the following minimum for denial. Changes: We have revised Appendix ‘‘enables LEAs to operate innovative, evidence related to criterion (F)(2) A to add to the minimum evidence autonomous public schools other than (proposed criterion (D)(2)): (1) A required for evaluating a State’s charter schools.’’ Criterion (F)(3) description of the State’s charter school performance against criterion (F)(2)(ii) (proposed criterion (E)(1)(iii), laws and a link or citation to the the number of charter school Demonstrating Other Significant Reform relevant statutory or regulatory sections; applications made in the State in each Conditions, will measure the extent to (2) the number and types of charter of the past five years, the number of which a State, in addition to schools currently operating in the State; charter school applications approved, information provided under other State (3) a description of the State’s approach the number of charter school Reform Conditions Criteria, has created to charter school accountability and applications denied, and reasons for the through law, regulation, or policy, other authorization, and a copy of the State’s denial (academic, financial, low conditions favorable to education applicable statutes, regulations, or other enrollment, other). reform or innovation that have relevant documents; (4) the charter increased student achievement or Flexibility To Adopt Other Innovative schools authorizers’ historic graduation rates, narrowed achievement Models performance on accountability, as gaps, or resulted in other important evidenced by the number of charter Comment: Many commenters outcomes. schools closed or not renewed annually recommended that the final Race to the over the last five years, the reasons for Top priorities and requirements include Charter School Demographics each of these closures; (5) a copy of the flexibility for States to meet the State Comment: Several commenters State’s applicable statutes, regulations, Reform Conditions in proposed criterion claimed that charter schools do not or other relevant legal documents with (D)(2) (new criterion (F)(2)) by serve as many high-need students as respect to equitable funding and describing other innovative school and traditional public schools. In particular, facilities funding; (6) a description of governance reforms outside the charter some commenters stated that charter the State’s approach to charter school school model that they have schools enroll few students with funding, the amount of funding passed implemented in recent years. Several disabilities or English language learners through to charter schools per student commenters provided examples of such and recommended that charter schools and how these amounts compare with non-charter models of innovation and be required to accept and serve all traditional per-student funding reform, including magnet schools, students. Another commenter proposed allocations; and (7) a description of the schools within schools, and academies, language specifically requiring charter statewide facilities supports provided to and one commenter suggested simply school laws to ensure equitable access charter schools, if any. The Department substituting ‘‘model innovative schools’’ for poor and minority students, students understands the desire of commenters for ‘‘charter schools’’ in the criterion. with disabilities, and English language for more and different types of data on One commenter recommended that the learners. One commenter asserted that charter schools, but is concerned about final notice permit States and LEAs to charter schools in one State ‘‘are striking the right balance between propose their own innovative school selectively resegregating schools based collecting the data essential for intervention models and strategies, on language, special education, and evaluating Race to the Top applications supported by ‘‘theoretical and research- poverty status and thus undercutting the and avoiding additional or duplicative based justification’’ and an evaluation equity and access guaranteed by civil burdens on States, charter school plan. Finally, one commenter urged a rights and school adequacy legislation.’’ authorizers, charter schools, and LEAs. greater emphasis on LEAs, rather than In response to similar concerns, another For example, charter school individual schools, as the ‘‘unit of commenter proposed that the final demographic and performance data, change’’ in turnaround efforts. notice require charter school including AYP and identification for Discussion: The Department agrees applications to include specific plans ESEA school improvement, generally that States applying for a Race to the for educating students with disabilities, are available from States and LEAs, but Top grant should receive credit for while another recommended a are not directly relevant to assessing a enabling LEAs to operate innovative, requirement for charter schools to ‘‘take State’s record in increasing the number autonomous public schools other than affirmative constitutional steps to of high-performing charter schools. charter schools. Accordingly, we have become racially and economically Collecting actual funding data would be added new criterion (F)(2)(v) and a integrated.’’ Two commenters called for burdensome and, once collected, related definition of innovative, a new criterion within (F)(2) that would
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measure the extent to which a State implementation of strategies to re- (A)(2)(ii)(b) from which States can collects data on the student populations engage students at risk of dropping out obtain statements or actions of support served by its charter schools, including of high school and to re-enroll students in order to demonstrate statewide students with disabilities, English who already have left school. However, support for their Race to the Top plans. language learners, and students from we believe that such strategies would Charter Schools and Teacher Shortages low-income families, as well as the have the greatest impact as part of the extent to which the student populations Race to the Top competition if they are Comment: One commenter overall in charter schools are incorporated into school intervention recommended that the final notice comparable to those in non-charter models rather than limited to new include provisions designed to help schools. charter schools. For example, as traditional public schools in areas with Discussion: We agree that charter described in the responses to comments persistent teacher shortages to replace schools should be encouraged to serve under section (E), Turning Around the staff lost to area charter schools. student populations that are similar to Lowest-Achieving Schools, the Discussion: The Department local district student populations, transformation model adopted from the acknowledges that charter schools especially relative to high-need School Improvement Grants program compete with existing regular public students, and we are revising criterion includes several activities aimed at re- schools for students, teachers, staff, and (F)(2)(ii) to reflect this. We also note engaging high school dropouts, such as other resources in the communities in that, at least at the national level, the credit-recovery programs, re- which they operate. We also recognize available data suggest that charter engagement strategies, and performance- that such resources may be in short schools do serve as many high-need based assessments. In addition, the supply in smaller communities and students as regular public schools. For transformation model may include towns, particularly in isolated rural example, the latest data from the opportunities to enroll in advanced areas. However, dynamic charter Department’s Schools and Staffing coursework, early-college high schools, schools can also attract new teachers Survey show that in the 2007–2008 and dual-enrollment programs. and principals to the community or school year, 35.6 percent of charter Changes: None. even the profession, and so we should school students received Title I services, Non-LEA Charter Schools not assume that any charter school gain compared to 29.1 percent of students in is a loss for traditional public schools. traditional public schools; the Comment: One commenter expressed Changes: None. percentage of students with concern that non-LEA charter schools Individualized Education Programs in could be excluded from Race to the Top Collective Bargaining charter schools and traditional public activities if their LEAs choose not to Comment: One commenter schools was about the same at roughly participate in the program. This recommended the addition of language 12 percent; and the percentage of commenter recommended that a State’s in criterion (F)(2) on the extent to which English language learners served by Race to the Top application should a State can show that it has not imposed charter schools exceeded the percentage include the participation and barriers to the unionization of charter of such students served by traditional endorsement of its public charter school employees. public schools, 16.5 percent to 11.2 schools regardless of their status as Discussion: Criterion (F)(2) was percent. Regarding the suggestion for LEAs, and that non-LEA charter schools intended to help assess, for the purpose further data collections, we note that the should be eligible for participation in of determining Race to the Top awards, latter data, at least for established Race to the Top activities and funding the extent to which a State has removed charter schools, are readily available even if their LEA declines to participate. barriers to the creation and expansion of Discussion: The Department through the Common Core of Data high-performing charter schools. understands the commenter’s concern collected and maintained by the Because the Department believes that that the structural limitations of non- Department’s National Center for many high-performing charter schools LEA charter schools may affect their Education Statistics. have non-unionized employees, it does ability to participate in the Race to the Changes: Criterion (F)(2)(ii) now not believe that a State law or regulation Top program if their LEAs elect not to specifies that authorizers should find that prohibits the unionization of participate in the program. To help ways to ‘‘encourage charter schools that charter school employees constitutes a provide a voice for these charter serve student populations that are barrier to the creation and expansion of schools, criterion (A)(2)(ii)(b) adds State similar to local district student high-performing charter schools. charter school membership associations populations, especially relative to high- Accordingly, the Department declines to to the list of stakeholders from which need students.’’ address this issue in this final notice. States are encouraged to obtain Changes: None. Re-Engaging High School Dropouts statements or actions of support in order Comment: Three commenters to demonstrate statewide support for IV. Definitions recommended that the final notice their Race to the Top plans. Also, States Proposed New Definitions include in (F)(2) a criterion focused on have discretion to use their share of the extent to which a State encourages Race to the Top grant funds (i.e., the 50 Comment: Commenters recommended the development of charter schools that percent of a State’s award that is not adding a number of definitions for this re-enroll high school dropouts, allocated to participating LEAs program, including definitions for including the extent to which the State according to relative shares of ESEA applied learning opportunities, college supports the provision of credit to such Title I, Part A formula allocations) to and career ready standards, chronic students based on performance rather support Race to the Top activities in absenteeism, community, community than instructional time, efforts to non-LEA charter schools, as well as any engagement, community partners, promote on-time graduation, and early other public schools in participating comprehensive learning supports, access to college coursework. and non-participating LEAs. conditions for learning, enrichment, Discussion: The Department agrees Changes: We have added State charter family engagement, open educational that the Race to the Top criteria should school membership organizations to the resources, response to intervention, encourage the development and list of stakeholders in criterion schools as the center of community,
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stakeholder, student, student mobility, the proposed definition. Commenters students with disabilities served under teacher, and universal design, as well as suggested revising the definition to the IDEA may remain in school until age other specific terms related to Race to avoid excluding appropriate classroom 21. Finally, one commenter the Top requirements and criteria. practices that function as formative recommended including GED recipients Discussion: As we discuss in other assessments. Other commenters in the definition, as well as students sections of this notice, we have added recommended that the definition be who need more than four years to a number of definitions in response to changed to require that formative graduate from high school, such as comments, but we are not adding assessments adhere to the principles of English language learners and other definitions for the terms suggested by universal design to ensure accessibility ‘‘high risk’’ students. these commenters. In some cases, we for all students; be designed to address Discussion: The commenters are thought that defining some of the terms a specific set of academic standards; and correct in noting that the graduation mentioned by the commenters could be integrated in comprehensive rate definition in the NPP was based on hinder the kind of innovation and fresh improvement plans. Other commenters the definition in 34 CFR 200.19(b)(1), thinking that Race to the Top is recommended that the definition state which was published as a final rule on intended to encourage and we did not that formative assessments may be October 29, 2008. In the NPP and this wish to constrain the activities that developed by a test vendor or an LEA. notice, graduation rate is defined as the might be promoted or supported by the Discussion: The Department agrees four-year or extended-year adjusted Race to the Top program. In other cases, with the commenter that ‘‘instant’’ cohort graduation rate. An extended- particularly where there is uncertainty feedback is not the goal of formative year adjusted cohort rate includes or conflicting views on the meaning of assessments; rather the goal is to students who take more than four years terms, we were reluctant to make any provide feedback in a timely enough to graduate and would include students decisions absent a more thorough fashion for the information to be used to who drop out of school and re-enroll, consideration of the issues involved adjust instruction and to improve English language learners, students with than has been provided through the learning. Accordingly, we are changing disabilities, and other students who public comment process on the Race to ‘‘instant feedback’’ to ‘‘timely need more than four years to graduate the Top program. The forthcoming feedback.’’ We also agree that the with a regular high school diploma. We reauthorization of the ESEA, for definition of formative assessment realize that the definition of graduation example, would be a more appropriate should be appropriately broad and rate in the NPP could have been stated vehicle for defining many of the flexible to accommodate a variety of more clearly and we are, therefore, proposed terms that could have broad classroom practices; we are therefore simplifying the definition in this notice implications for a range of Federal changing the definition to refer to to mean ‘‘the four-year or extended-year education programs. Finally, in some ‘‘assessment questions, tools, and adjusted cohort graduation rate as cases, adding a definition was not processes,’’ rather than just ‘‘processes.’’ defined by 34 CFR 200.19(b)(1).’’ Note, essential for successful administration We decline to change the definition in however, that the definition does not of the Race to the Top program. the manner recommended by the other include GED recipients because a GED Changes: None. commenters because doing so would is not a regular high school diploma. unnecessarily narrow the definition of a Alternative credentials such as the GED Final Definitions formative assessment. are not aligned with a State’s academic Alternative routes to certification: See Changes: We have changed the phrase content standards and, if included in Section D, Great Teachers and Leaders, ‘‘formative assessment means an the definition of graduation rate, would for the discussion of comments related assessment process’’ to ‘‘formative provide a misleading account of the to this definition. assessment means assessment questions, percentage of students who graduate College enrollment: This is a tools, and processes.’’ We also have with a diploma that reflects what a State definition that has been added in changed the phrase ‘‘to provide instant determines all students should know response to comments. See Section A, feedback on student understanding and and be able to do by the end of the 12th State Success Factors, for the to adjust ongoing teaching and learning grade. discussion. accordingly’’ to ‘‘provide timely Changes: We have changed the Common set of K–12 standards: See feedback for purposes of adjusting language in the definition of graduation Section B, Standards and Assessments, instruction to improve learning.’’ rate to clarify that graduation rate for the discussion of comments related Graduation Rate means ‘‘the four-year or extended-year to this definition. adjusted cohort graduation rate as Effective principal: See Section D, Comment: Some commenters defined by 34 CFR 200.19(b)(1).’’ Great Teachers and Leaders, for the supported the proposed definition of Highly effective principal: See Section discussion of comments related to this graduation rate, noting that it is the D, Great Teachers and Leaders, for the definition. same definition published by the discussion of comments related to this Effective teacher: See Section D, Great Department in the Title I regulations the definition. Teachers and Leaders, for the discussion Department issued in October 2008. Highly effective teacher: See Section of comments related to this definition. However, others suggested changes to D, Great Teachers and Leaders, for the the definition. One commenter called Formative Assessment discussion of comments related to this for the definition to include dropouts definition. Comment: Commenters recommended who re-enroll in high school and take High-minority school: This is a several changes to the proposed longer than four years to graduate. definition that has been added in definition of formative assessment. One Another commenter asked whether response to comments. See Section D, commenter noted that formative students who graduate from high school Great Teachers and Leaders, for the assessments use a variety of strategies to in five or six years would be included discussion. provide timely feedback to teachers and and urged the Department to give students, but that not all formative incentives to LEAs that re-enroll High-Need LEA assessments necessarily provide the dropouts. Another commenter said the Comment: A few commenters noted ‘‘instant’’ feedback that is included in definition should take into account that that the definition of high-need LEA in
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the NPP was inconsistent with the High-quality assessment: See Section the fact that current statewide definition in section 14013 of the B, Standards and Assessments, for the longitudinal data systems do not allow ARRA. discussion of comments related to this for data to be processed this quickly. Discussion: We acknowledge this definition. Commenters noted that the scoring error and are replacing the proposed Increased learning time: This is a processes for different types of items definition of high-need LEA with the definition that has been added in that could be included in formative, definition in section 14013 of the response to comments. See Section E, summative, and interim assessments ARRA. Turning Around the Lowest-Achieving and the means by which the assessment Changes: We have replaced the Schools, for the discussion. is administered (e.g., online or on paper) proposed definition of high-need LEA Innovative, autonomous public could affect the timeline for returning with the following definition from schools: This is a definition that has data. One commenter suggested that section 14013 of the ARRA: ‘‘an LEA (a) been added in response to comments. States be allowed to create their own that serves not fewer than 10,000 See Section F, General, for the definitions of rapid-time and that the children from families with incomes discussion. Department evaluate these definitions below the poverty line; or (b) for which Instructional improvement systems: during its review of Race to the Top not less than 20 percent of the children See Section C, Data Systems to Support applications. Another commenter served by the LEA are from families Instruction, for the discussion of recommended defining rapid-time based with incomes below the poverty line.’’ comments related to this definition. on whether or not the data could be High-Need Students used to inform current instruction. Interim Assessment Discussion: The Department agrees Comment: Several commenters Comment: A few commenters with commenters that specifying the requested that the final notice include a suggested that the definition of interim amount of time for returning assessment definition of high-need students. A few assessment be amended to include the data should be removed from the commenters recommended that the use of universal design principles. definition of rapid time. We also are definition of high-need students include Discussion: Because interim clarifying the definition of rapid-time by students who have left school assessments are often created by including a specific reference to locally- prematurely and students who are over teachers for their own use in the collected assessment data, as rapid-time age and under credited for on-time classroom, the Department believes that data are specifically used to inform graduation. Another commenter requiring that interim assessments use classroom-level decisions and thus recommended the definition include universal design principles would place consist primarily of data that are students who drop out of school and too onerous a burden on teachers, who collected locally. Removing the concept later re-enroll in school. A few may not have the expertise to create that assessment data should be returned commenters focused on the needs of assessments using universal design within 72 hours and clarifying that struggling students who are off-track to principles. However, the Department is rapid time refers to locally-collected graduate and at risk of dropping out, in no way discouraging the use of data address commenters’ concerns including students that need to balance universal design principles in interim or regarding the potential negative impact school and work. any other assessments. the proposed definition could have had Discussion: We agree that we should Changes: None. on the types of assessments and item define high-need students and are Involved LEAs: This is a definition types used on these assessments. including in the definition references to that has been added in response to Changes: The Department has revised students who are far below grade level, comments. See Section A, State Success the definition of rapid-time to read as students who left school before Factors, for the discussion. follows: ‘‘Rapid-time, in reference to receiving a regular high school diploma, Low-minority school: This is a reporting and availability of locally- and students at risk of not graduating definition that has been added in collected school- and LEA-level data, with a diploma on time, among others. response to comments. See Section D, means that data are available quickly Changes: We have added the Great Teachers and Leaders, for the enough to inform current lessons, following in the Definition section of discussion. instruction, and related supports.’’ the final notice: ‘‘High-need students Low-poverty school: This is a Student Achievement means students at risk of educational definition that has been added in failure or otherwise in need of special response to comments. See Section D, Comment: The Department received a assistance and support, such as students Great Teachers and Leaders, for the very large number of comments on the who are living in poverty, who attend discussion. proposed definition of student high minority schools (as defined in this Participating LEAs: This is a achievement, which used, as a basis, a notice), who are far below grade level, definition that has been added in student’s scores on State assessments in who have left school before receiving a response to comments. See Section A, reading/language arts, mathematics, and regular high school diploma, who are at State Success Factors, for the science required by section 1111(b)(3) of risk of not graduating with a diploma on discussion. the ESEA. A majority of these comments time, who are homeless, who are in Persistently lowest-achieving schools: focused on the language in the NPP foster care, who have been incarcerated, See Section E, Turning Around the regarding the definition of student who have disabilities, or who are Lowest-Achieving Schools, for the achievement for non-tested grades and English language learners.’’ discussion of comments related to this subjects, which referred to alternative High-performing charter school: This definition. measures of student performance such is a definition that has been added in as student performance on interim response to comments. See Section F, Rapid-Time assessments and the percentage of General, for the discussion. Comments: Commenters students enrolled in Advanced High-poverty school: See Section D, recommended that we reconsider or Placement courses who take Advanced Great Teachers and Leaders, for the remove the statement in the definition Placement exams. These commenters discussion of comments related to this of rapid-time that assessment data suggested that such alternative measures definition. should be returned in 72 hours, citing also should include statewide
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assessments whenever possible, the use appropriate, (2) other measures of education reform. The State must of college or career-readiness tests, student learning, such as those demonstrate in its application sufficient performance-based assessments, described in paragraph (b) of this LEA participation and commitment to portfolio assessments, course definition, provided they are rigorous successfully implement and achieve the completion rates, and career and and comparable across classrooms. goals in its plans; and it must describe technical education measures. Also, (b) For non-tested grades and subjects: how the State, in collaboration with its many commenters opposed the use of alternative measures of student learning participating LEAs, will use Race to the IEP goals as an example of an alternative and performance such as student scores Top and other funds to increase student student achievement measure. Other on pre-tests and end-of-course tests; achievement, decrease the achievement commenters recommended student performance on English gaps across student subgroups, and supplementing scores on ESEA language proficiency assessments; and increase the rates at which students assessments with multiple, alternative other measures of student achievement graduate from high school prepared for measures of student performance for all that are rigorous and comparable across college and careers. students, including specific suggestions classrooms. such as attendance, on-time promotion Student growth: See Section D, Great Priority 2: Competitive Preference rates, college enrollment and Teachers and Leaders, for the discussion Priority—Emphasis on Science, completion rates, and other State- of comments related to this definition. Technology, Engineering, and proposed indicators. Total Revenues available to the State: Mathematics (STEM) Discussion: In reviewing these See Section F, General, for the comments, it became clear that there To meet this priority, the State’s discussion of comments related to this application must have a high-quality were several components of the definition. definition of student achievement that plan to address the need to (i) offer a America COMPETES Act elements: rigorous course of study in mathematics, were unnecessarily confusing. First, the See Section C, Data Systems to Support use of the phrase ‘‘at a minimum,’’ the sciences, technology, and Instruction, for the discussion of engineering; (ii) cooperate with industry which we believed, for tested grades comments related to this definition. and subjects, provided States with the experts, museums, universities, research flexibility to supplement ESEA Final Priorities centers, or other STEM-capable community partners to prepare and assessment results with a wide range of When inviting applications for a assist teachers in integrating STEM other measures of student achievement competition using one or more content across grades and disciplines, in and performance, confused some priorities, we designate the type of each promoting effective and relevant commenters. To avoid further confusion priority as absolute, competitive instruction, and in offering applied we are revising the definition to remove preference, or invitational through a learning opportunities for students; and the phrase ‘‘at a minimum,’’ and adding, notice in the Federal Register. The (iii) prepare more students for advanced for tested grades and subjects, the Secretary establishes the following study and careers in the sciences, phrase, ‘‘other measures of student priorities for this competition: technology, engineering, and learning, such as those described in Absolute priority: Under an absolute mathematics, including by addressing paragraph (b) of this definition, priority, we consider only applications the needs of underrepresented groups provided they are rigorous and that meet the priority (34 CFR and of women and girls in the areas of comparable across classrooms.’’ As for 75.105(c)(3)). science, technology, engineering, and alternative measures in non-tested Competitive preference priority: mathematics. grades, we note that the alternatives Under 34 CFR 75.105(c)(2)(i), we give included in the proposed definition of competitive preference to an application Priority 3: Invitational Priority— student achievement were examples by awarding additional points to Innovations for Improving Early only; however, we agree with the many applications that meet this priority or Learning Outcomes commenters who reminded us that IEPs selecting an application that meets the are individualized and that IEP goals priority over an application of The Secretary is particularly often include student needs that are not comparable merit that does not meet the interested in applications that include based on academic content. For these priority. practices, strategies, or programs to reasons, it is not appropriate to evaluate Invitational priority: Under an improve educational outcomes for high- student achievement based on IEP goals, invitational priority, we are particularly need students who are young children and we are removing IEPs from the list interested in applications that meet the (pre-kindergarten through third grade) of possible alternative measures. We priority. However, we do not give an by enhancing the quality of preschool also are modifying the other examples of application that meets the priority a programs. Of particular interest are potential alternative measures of preference over other applications (34 proposals that support practices that (i) student performance for non-tested CFR 75.105(c)(1)). improve school readiness (including grades and subjects. Again, we note that social, emotional, and cognitive); and these alternative measures are examples Priorities (ii) improve the transition between only, and States, LEAs, and schools Priority 1: Absolute Priority— preschool and kindergarten. have great latitude to use their own Comprehensive Approach to Education Priority 4: Invitational Priority— rigorous alternative measures of student Reform achievement and performance in Expansion and Adaptation of Statewide implementing their Race to the Top To meet this priority, the State’s Longitudinal Data Systems plans. application must comprehensively and Changes: The definition of student coherently address all of the four The Secretary is particularly achievement has been revised to read as education reform areas specified in the interested in applications in which the follows: Student achievement means— ARRA as well as the State Success State plans to expand statewide (a) For tested grades and subjects: (1) Factors Criteria in order to demonstrate longitudinal data systems to include or a student’s score on the State’s that the State and its participating LEAs integrate data from special education assessments under the ESEA; and, as are taking a systemic approach to programs, English language learner
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programs,10 early childhood programs, State’s participating LEAs (as defined in (c) The State must include a budget at-risk and dropout prevention this notice) seek to create the conditions that details how it will use grant funds programs, and school climate and for reform and innovation as well as the and other resources to meet targets and culture programs, as well as information conditions for learning by providing perform related functions (as described on student mobility, human resources schools with flexibility and autonomy in criterion (A)(2)(i)(d)), including how (i.e., information on teachers, in such areas as— it will use funds awarded under this principals, and other staff), school (i) Selecting staff; program to— finance, student health, postsecondary (ii) Implementing new structures and (1) Achieve its targets for improving education, and other relevant areas, formats for the school day or year that student achievement and graduation with the purpose of connecting and result in increased learning time (as rates and for closing achievement gaps coordinating all parts of the system to defined in this notice); (as described in criterion (A)(1)(iii)); the allow important questions related to (iii) Controlling the school’s budget; State must also describe its track record policy, practice, or overall effectiveness (iv) Awarding credit to students based of improving student progress overall to be asked, answered, and incorporated on student performance instead of and by student subgroup (as described into effective continuous improvement instructional time; in criterion (A)(3)(ii)); and (v) Providing comprehensive services practices. (2) Give priority to high-need LEAs The Secretary is also particularly to high-need students (as defined in this notice) (e.g., by mentors and other (as defined in this notice), in addition interested in applications in which to providing 50 percent of the grant to States propose working together to caring adults; through local partnerships with community-based organizations, participating LEAs (as defined in this adapt one State’s statewide longitudinal notice) based on their relative shares of data system so that it may be used, in nonprofit organizations, and other providers); funding under Part A of Title I of the whole or in part, by one or more other ESEA for the most recent year as States, rather than having each State (vi) Creating school climates and cultures that remove obstacles to, and required under section 14006(c) of the build or continue building such systems ARRA. (Note: Because all Race to the independently. actively support, student engagement and achievement; and Top grants will be made in 2010, Priority 5: Invitational Priority—P–20 (vii) Implementing strategies to relative shares will be based on total Coordination, Vertical and Horizontal effectively engage families and funding received in FY 2009, including Alignment communities in supporting the both the regular Title I, Part A The Secretary is particularly academic success of their students. appropriation and the amount made available by the ARRA). interested in applications in which the Final Requirements State plans to address how early (d) The State must provide, for each childhood programs, K–12 schools, The Secretary establishes the State Reform Conditions Criterion postsecondary institutions, workforce following requirements for this program. (listed in this notice) that it chooses to development organizations, and other Eligibility Requirements address, a description of the State’s State agencies and community partners current status in meeting that criterion A State must meet the following and, at a minimum, the information (e.g., child welfare, juvenile justice, and requirements in order to be eligible to criminal justice agencies) will requested as supporting evidence for the receive funds under this program. criterion and the performance measures, coordinate to improve all parts of the (a) The State’s applications for education system and create a more if any (see Appendix A). funding under Phase 1 and Phase 2 of (e) The State must provide, for each seamless preschool-through-graduate the State Fiscal Stabilization Fund school (P–20) route for students. Reform Plan Criterion (listed in this program must be approved by the notice) that it chooses to address, a Vertical alignment across P–20 is Department prior to the State being particularly critical at each point where detailed plan for use of grant funds that awarded a Race to the Top grant. includes, but need not be limited to— a transition occurs (e.g., between early (b) At the time the State submits its (1) The key goals; childhood and K–12, or between K–12 application, there must not be any legal, and postsecondary/careers) to ensure statutory, or regulatory barriers at the (2) The key activities to be undertaken that students exiting one level are State level to linking data on student and rationale for the activities, which prepared for success, without achievement (as defined in this notice) should include why the specific remediation, in the next. Horizontal or student growth (as defined in this activities are thought to bring about the alignment, that is, coordination of notice) to teachers and principals for the change envisioned and how these services across schools, State agencies, purpose of teacher and principal activities are linked to the key goals; and community partners, is also evaluation. (3) The timeline for implementing the important in ensuring that high-need activities; students (as defined in this notice) have Application Requirements (4) The party or parties responsible for access to the broad array of (a) The State’s application must be implementing the activities; opportunities and services they need signed by the Governor, the State’s chief (5) The information requested in the and that are beyond the capacity of a school officer, and the president of the performance measures, where school itself to provide. State board of education (if applicable). applicable (see Appendix A), and where the State proposes plans for reform Priority 6: Invitational Priority—School- States will respond to this requirement efforts not covered by a specified Level Conditions for Reform, in the application, Section III, Race to performance measure, the State is Innovation, and Learning the Top Application Assurances. In addition, the assurances in Section IV encouraged to propose performance The Secretary is particularly must be signed by the Governor. measures and annual targets for those interested in applications in which the (b) The State must describe the efforts; and progress it has made over the past (6) The information requested as 10 The term English language learner, as used in several years in each of the four supporting evidence, if any, for the this notice, is synonymous with the term limited English proficient, as defined in section 9101 of the education reform areas (as described in criterion, together with any additional ESEA. criterion (A)(3)(i)). information the State believes will be
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helpful to peer reviewers in judging the addition to the standard elements, a Æ the State’s progress in reducing credibility of the State’s plan. description of the State’s and its LEAs’ inequities in the distribution of highly (f) The State must submit a progress to date on their goals, qualified teachers, implementing a State certification from the State Attorney timelines, and budgets, as well as actual longitudinal data system, and General that— performance compared to the annual developing and implementing valid and (1) The State’s description of, and targets the State established in its reliable assessments for English statements and conclusions concerning application with respect to each language learners and students with State law, statute, and regulation in its performance measure. Further, a State disabilities; and application are complete, accurate, and receiving funds under this program and Æ if applicable, a description of each constitute a reasonable interpretation of its participating LEAs are accountable modernization, renovation, or repair State law, statute, and regulation; and for meeting the goals, timelines, budget, project approved in the State (2) At the time the State submits its and annual targets established in the application and funded, including the application, the State does not have any application; adhering to an annual fund amounts awarded and project costs legal, statutory, or regulatory barriers at drawdown schedule that is tied to (ARRA Division A, Section 14008). the State level to linking data on student meeting these goals, timelines, budget, Program Requirements achievement or student growth to and annual targets; and fulfilling and teachers and principals for the purpose maintaining all other conditions for the Evaluation: The Institute of Education of teacher and principal evaluation. conduct of the project. The Department Sciences (IES) will conduct a series of (g) When addressing issues relating to will monitor a State’s and its national evaluations of Race to the Top’s assessments required under the ESEA or participating LEAs’ progress in meeting State grantees as part of its evaluation of subgroups in the selection criteria, the the State’s goals, timelines, budget, and programs funded under the ARRA. The State must meet the following annual targets and in fulfilling other Department’s goal for these evaluations requirements: applicable requirements. In addition, is to ensure that its studies not only (1) For student subgroups with the Department may collect additional assess program impacts, but also respect to the NAEP, the State must data as part of a State’s annual reporting provide valuable information to State provide data for the NAEP subgroups requirements. and local educators to help inform and described in section 303(b)(2)(G) of the To support a collaborative process improve their practices. National Assessment of Educational between the State and the Department, The Department anticipates that the Progress Authorization Act (20 U.S.C. the Department may require that national evaluations will involve such 9622) (i.e., race, ethnicity, applicants who are selected to receive components as— socioeconomic status, gender, disability, an award enter into a written • Surveys of States, LEAs, and/or and limited English proficiency). The performance or cooperative agreement schools, which will help identify how State must also include the NAEP with the Department. If the Department program funding is spent and the exclusion rate for students with determines that a State is not meeting its specific efforts and activities that are disabilities and the exclusion rate for goals, timelines, budget, or annual underway within each of the four English language learners, along with targets or is not fulfilling other education reform areas and across clear documentation of the State’s applicable requirements, the selected ARRA-funded programs; policies and practices for determining Department will take appropriate action, • whether a student with a disability or an Case studies of promising practices which could include a collaborative English language learner should in States, LEAs, and/or schools through process between the Department and the participate in the NAEP and whether surveys and other mechanisms; and State, or enforcement measures with • the student needs accommodations; Evaluations of outcomes, focusing (2) For student subgroups with respect to this grant, such as placing the on student achievement and other respect to high school graduation rates, State in high-risk status, putting the performance measures, to determine the college enrollment and credit State on reimbursement payment status, impact of the reforms implemented accumulation rates, and the assessments or delaying or withholding funds. under Race to the Top. required under the ESEA, the State must A State that receives Race to the Top Race to the Top grantee States are not provide data for the subgroups funds must also meet the reporting required to conduct independent described in section 1111(b)(2)(C)(v)(II) requirements that apply to all ARRA- evaluations, but may propose, within of the ESEA (i.e., economically funded programs. Specifically, the State their applications, to use funds from disadvantaged students, students from must submit reports, within 10 days Race to the Top to support such major racial and ethnic groups, students after the end of each calendar quarter, evaluations. Grantees must make with disabilities, and students with that contain the information required available, through formal (e.g., peer- limited English proficiency); and under section 1512(c) of the ARRA in reviewed journals) or informal (e.g., (3) When asked to provide accordance with any guidance issued by newsletters, Web sites) mechanisms, the information regarding the assessments the Office of Management and Budget or results of any evaluations they conduct required under the ESEA, States should the Department (ARRA Division A, of their funded activities. In addition, as refer to section 1111(b)(3) of the ESEA; Section 1512(c)). described elsewhere in this notice and in addition, when describing this In addition, for each year of the regardless of the final components of the assessment data in the State’s program, the State will submit a report national evaluation, Race to the Top application, the State should note any to the Secretary, at such time and in States, LEAs, and schools are expected factors (e.g., changes in cut scores) that such manner as the Secretary may to identify and share promising would impact the comparability of data require, that describes: practices, make work available within Æ from one year to the next. The uses of funds within the State; and across States, and make data Æ how the State distributed the funds available in appropriate ways to Reporting Requirements it received; stakeholders and researchers so as to A State receiving Race to the Top Æ the number of jobs that the help all States focus on continuous funds must submit to the Department an Governor estimates were saved or improvement in service of student annual report which must include, in created with the funds; outcomes.
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Participating LEA Scope of Work: The the State’s plans and to effective statewide education reform plans the agreements signed by participating implementation of reform in the four State has proposed; LEAs (as defined in this notice) must education areas, as evidenced by (b) Supporting participating LEAs (as include a scope-of-work section. The Memoranda of Understanding (MOUs) defined in this notice) in successfully scope of work submitted by LEAs and (as set forth in Appendix D) 11 or other implementing the education reform States as part of their Race to the Top binding agreements between the State plans the State has proposed, through applications will be preliminary. and its participating LEAs (as defined in such activities as identifying promising Preliminary scopes of work should this notice) that include— practices, evaluating these practices’ include the portions of the State’s (a) Terms and conditions that reflect effectiveness, ceasing ineffective proposed reform plans that the LEA is strong commitment by the participating practices, widely disseminating and agreeing to implement. If a State is LEAs (as defined in this notice) to the replicating the effective practices awarded a Race to the Top grant, its State’s plans; statewide, holding participating LEAs participating LEAs (as defined in this (b) Scope-of-work descriptions that (as defined in this notice) accountable notice) will have up to 90 days to require participating LEAs (as defined for progress and performance, and complete final scopes of work, which in this notice) to implement all or intervening where necessary; must contain detailed work plans that significant portions of the State’s Race (c) Providing effective and efficient are consistent with their preliminary to the Top plans; and operations and processes for scopes of work and with the State’s (c) Signatures from as many as implementing its Race to the Top grant grant application, and should include possible of the LEA superintendent (or in such areas as grant administration equivalent), the president of the local the participating LEAs’ specific goals, and oversight, budget reporting and school board (or equivalent, if activities, timelines, budgets, key monitoring, performance measure applicable), and the local teachers’ personnel, and annual targets for key tracking and reporting, and fund union leader (if applicable) (one performance measures. disbursement; signature of which must be from an Making Work Available: Unless (d) Using the funds for this grant, as authorized LEA representative) otherwise protected by law or agreement described in the State’s budget and demonstrating the extent of leadership as proprietary information, the State and accompanying budget narrative, to support within participating LEAs (as its subgrantees must make any work accomplish the State’s plans and meet (e.g., materials, tools, processes, defined in this notice); and (iii) The LEAs that are participating in its targets, including, where feasible, by systems) developed under its grant the State’s Race to the Top plans coordinating, reallocating, or freely available to others, including but (including considerations of the repurposing education funds from other not limited to by posting the work on a numbers and percentages of Federal, State, and local sources so that Web site identified or sponsored by the participating LEAs, schools, K–12 they align with the State’s Race to the Department. Top goals; and Technical Assistance: The State must students, and students in poverty) will translate into broad statewide impact, (e) Using the fiscal, political, and participate in applicable technical allowing the State to reach its ambitious human capital resources of the State to assistance activities that may be yet achievable goals, overall and by continue, after the period of funding has conducted by the Department or its student subgroup, for— ended, those reforms funded under the designees. (a) Increasing student achievement in grant for which there is evidence of State Summative Assessments: No (at a minimum) reading/language arts success; and funds awarded under this competition and mathematics, as reported by the (ii) Use support from a broad group of may be used to pay for costs related to NAEP and the assessments required stakeholders to better implement its statewide summative assessments. under the ESEA; plans, as evidenced by the strength of Final Selection Criteria (b) Decreasing achievement gaps statements or actions of support from— The Secretary establishes the between subgroups in reading/language (a) The State’s teachers and following criteria for reviewing arts and mathematics, as reported by the principals, which include the State’s applications submitted under this NAEP and the assessments required teachers’ unions or statewide teacher program. In the Scoring Rubric, in under the ESEA; associations; and (c) Increasing high school graduation Appendix B, the Secretary establishes (b) Other critical stakeholders, such as rates (as defined in this notice); and the State’s legislative leadership; charter the maximum number of points (d) Increasing college enrollment (as assigned to each criterion. school authorizers and State charter defined in this notice) and increasing school membership associations (if A. State Success Factors the number of students who complete at applicable); other State and local leaders (A)(1) Articulating State’s education least a year’s worth of college credit that (e.g., business, community, civil rights, is applicable to a degree within two reform agenda and LEAs’ participation and education association leaders); years of enrollment in an institution of in it: The extent to which— Tribal schools; parent, student, and (i) The State has set forth a higher education. community organizations (e.g., parent- (A)(2) Building strong statewide comprehensive and coherent reform teacher associations, nonprofit capacity to implement, scale up, and agenda that clearly articulates its goals organizations, local education sustain proposed plans: The extent to for implementing reforms in the four foundations, and community-based which the State has a high-quality education areas described in the ARRA organizations); and institutions of overall plan to— higher education. and improving student outcomes (i) Ensure that it has the capacity (A)(3) Demonstrating significant statewide, establishes a clear and required to implement its proposed progress in raising achievement and credible path to achieving these goals, plans by— and is consistent with the specific (a) Providing strong leadership and closing gaps: The extent to which the reform plans that the State has proposed dedicated teams to implement the State has demonstrated its ability to— throughout its application; (i) Make progress over the past several (ii) The participating LEAs (as defined 11 See Appendix D for more on participating LEA years in each of the four education in this notice) are strongly committed to MOUs and for a model MOU. reform areas, and used its ARRA and
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other Federal and State funding to evidenced by (as set forth in Appendix teachers, principals, LEA leaders, pursue such reforms; B) the State’s participation in a community members, unions, (ii) Improve student outcomes overall consortium of States that— researchers, and policymakers); and that and by student subgroup since at least (i) Is working toward jointly the data support decision-makers in the 2003, and explain the connections developing and implementing common, continuous improvement of efforts in between the data and the actions that high-quality assessments (as defined in such areas as policy, instruction, have contributed to— this notice) aligned with the operations, management, resource (a) Increasing student achievement in consortium’s common set of K–12 allocation, and overall effectiveness.13 reading/language arts and mathematics, standards (as defined in this notice); (C)(3) Using data to improve both on the NAEP and on the and instruction: The extent to which the assessments required under the ESEA; (ii) Includes a significant number of State, in collaboration with its (b) Decreasing achievement gaps States. participating LEAs (as defined in this between subgroups in reading/language notice), has a high-quality plan to— arts and mathematics, both on the NAEP Reform Plan Criteria (i) Increase the acquisition, adoption, and on the assessments required under (B)(3) Supporting the transition to and use of local instructional the ESEA; and enhanced standards and high-quality improvement systems (as defined in this (c) Increasing high school graduation assessments: The extent to which the notice) that provide teachers, principals, rates. State, in collaboration with its and administrators with the information participating LEAs (as defined in this and resources they need to inform and B. Standards and Assessments notice), has a high-quality plan for improve their instructional practices, State Reform Conditions Criteria supporting a statewide transition to and decision-making, and overall implementation of internationally effectiveness; (B)(1) Developing and adopting (ii) Support participating LEAs (as common standards: The extent to which benchmarked K–12 standards that build toward college and career readiness by defined in this notice) and schools that the State has demonstrated its are using instructional improvement commitment to adopting a common set the time of high school graduation, and high-quality assessments (as defined in systems (as defined in this notice) in of high-quality standards, evidenced by providing effective professional (as set forth in Appendix B)— this notice) tied to these standards. State or LEA activities might, for example, development to teachers, principals, (i) The State’s participation in a and administrators on how to use these consortium of States that— include: developing a rollout plan for the standards together with all of their systems and the resulting data to (a) Is working toward jointly support continuous instructional developing and adopting a common set supporting components; in cooperation with the State’s institutions of higher improvement; and of K–12 standards (as defined in this (iii) Make the data from instructional education, aligning high school exit notice) that are supported by evidence improvement systems (as defined in this criteria and college entrance that they are internationally notice), together with statewide requirements with the new standards benchmarked and build toward college longitudinal data system data, available and assessments; developing or and career readiness by the time of high and accessible to researchers so that acquiring, disseminating, and school graduation; and they have detailed information with (b) Includes a significant number of implementing high-quality instructional which to evaluate the effectiveness of States; and materials and assessments (including, instructional materials, strategies, and (ii)(a) For Phase 1 applications, the for example, formative and interim approaches for educating different types State’s high-quality plan demonstrating assessments (both as defined in this of students (e.g., students with its commitment to and progress toward notice)); developing or acquiring and disabilities, English language learners, adopting a common set of K–12 delivering high-quality professional students whose achievement is well standards (as defined in this notice) by development to support the transition to below or above grade level). August 2, 2010, or, at a minimum, by a new standards and assessments; and later date in 2010 specified by the State, engaging in other strategies that D. Great Teachers and Leaders and to implementing the standards translate the standards and information State Reform Conditions Criteria thereafter in a well-planned way; or from assessments into classroom (D)(1) Providing high-quality (b) For Phase 2 applications, the practice for all students, including high- pathways for aspiring teachers and State’s adoption of a common set of K– need students (as defined in this notice). principals: The extent to which the 12 standards (as defined in this notice) C. Data Systems To Support Instruction State has— by August 2, 2010, or, at a minimum, by State Reform Conditions Criteria (i) Legal, statutory, or regulatory a later date in 2010 specified by the provisions that allow alternative routes State in a high-quality plan toward (C)(1) Fully implementing a statewide to certification (as defined in this which the State has made significant longitudinal data system: The extent to notice) for teachers and principals, progress, and its commitment to which the State has a statewide particularly routes that allow for implementing the standards thereafter longitudinal data system that includes providers in addition to institutions of 12 in a well-planned way. all of the America COMPETES Act higher education; (B)(2) Developing and implementing elements (as defined in this notice). (ii) Alternative routes to certification common, high-quality assessments: The (as defined in this notice) that are in Reform Plan Criteria extent to which the State has use; and demonstrated its commitment to (C)(2) Accessing and using State data: (iii) A process for monitoring, improving the quality of its assessments, The extent to which the State has a evaluating, and identifying areas of high-quality plan to ensure that data 12 Phase 2 applicants addressing selection from the State’s statewide longitudinal 13 Successful applicants that receive Race to the criterion (B)(1)(ii) may amend their June 1, 2010 data system are accessible to, and used Top grant awards will need to comply with the application submission through August 2, 2010 by Family Educational Rights and Privacy Act submitting evidence of adopting common standards to inform and engage, as appropriate, (FERPA), including 34 CFR Part 99, as well as State after June 1, 2010. key stakeholders (e.g., parents, students, and local requirements regarding privacy.
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teacher and principal shortage and for (i) Ensure the equitable distribution of notice); and aligning systems and preparing teachers and principals to fill teachers and principals by developing a removing barriers to effective these areas of shortage. plan, informed by reviews of prior implementation of practices designed to actions and data, to ensure that students improve student learning outcomes; and Reform Plan Criteria in high-poverty and/or high-minority (ii) Measure, evaluate, and (D)(2) Improving teacher and schools (both as defined in this notice) continuously improve the effectiveness principal effectiveness based on have equitable access to highly effective of those supports in order to improve performance: The extent to which the teachers and principals (both as defined student achievement (as defined in this State, in collaboration with its in this notice) and are not served by notice). participating LEAs (as defined in this ineffective teachers and principals at E. Turning Around the Lowest- notice), has a high-quality plan and higher rates than other students; and Achieving Schools ambitious yet achievable annual targets (ii) Increase the number and to ensure that participating LEAs (as percentage of effective teachers (as State Reform Conditions Criteria defined in this notice) teaching hard-to- defined in this notice)— (E)(1) Intervening in the lowest- staff subjects and specialty areas (i) Establish clear approaches to achieving schools and LEAs: The extent including mathematics, science, and measuring student growth (as defined in to which the State has the legal, special education; teaching in language this notice) and measure it for each statutory, or regulatory authority to instruction educational programs (as individual student; intervene directly in the State’s defined under Title III of the ESEA); and (ii) Design and implement rigorous, persistently lowest-achieving schools teaching in other areas as identified by transparent, and fair evaluation systems (as defined in this notice) and in LEAs for teachers and principals that (a) the State or LEA. Plans for (i) and (ii) may include, but that are in improvement or corrective differentiate effectiveness using action status. multiple rating categories that take into are not limited to, the implementation account data on student growth (as of incentives and strategies in such Reform Plan Criteria areas as recruitment, compensation, defined in this notice) as a significant (E)(2) Turning around the lowest- teaching and learning environments, factor, and (b) are designed and achieving schools: The extent to which professional development, and human developed with teacher and principal the State has a high-quality plan and involvement; resources practices and processes. (D)(4) Improving the effectiveness of ambitious yet achievable annual targets (iii) Conduct annual evaluations of teacher and principal preparation to— teachers and principals that include (i) Identify the persistently lowest- programs: The extent to which the State timely and constructive feedback; as achieving schools (as defined in this has a high-quality plan and ambitious part of such evaluations, provide notice) and, at its discretion, any non- yet achievable annual targets to— teachers and principals with data on (i) Link student achievement and Title I eligible secondary schools that student growth for their students, student growth (both as defined in this would be considered persistently classes, and schools; and notice) data to the students’ teachers lowest-achieving schools (as defined in (iv) Use these evaluations, at a and principals, to link this information this notice) if they were eligible to minimum, to inform decisions to the in-State programs where those receive Title I funds; and (ii) Support its LEAs in turning regarding— teachers and principals were prepared around these schools by implementing (a) Developing teachers and for credentialing, and to publicly report one of the four school intervention principals, including by providing the data for each credentialing program models (as described in Appendix C): relevant coaching, induction support, in the State; and and/or professional development; (ii) Expand preparation and Turnaround model, restart model, (b) Compensating, promoting, and credentialing options and programs that school closure, or transformation model retaining teachers and principals, are successful at producing effective (provided that an LEA with more than including by providing opportunities for teachers and principals (both as defined nine persistently lowest-achieving highly effective teachers and principals in this notice). schools may not use the transformation (both as defined in this notice) to obtain (D)(5) Providing effective support to model for more than 50 percent of its additional compensation and be given teachers and principals: The extent to schools). additional responsibilities; which the State, in collaboration with F. General (c) Whether to grant tenure and/or full its participating LEAs (as defined in this certification (where applicable) to notice), has a high-quality plan for its State Reform Conditions Criteria teachers and principals using rigorous participating LEAs (as defined in this (F)(1) Making education funding a standards and streamlined, transparent, notice) to— priority: The extent to which— and fair procedures; and (i) Provide effective, data-informed (i) The percentage of the total (d) Removing ineffective tenured and professional development, coaching, revenues available to the State (as untenured teachers and principals after induction, and common planning and defined in this notice) that were used to they have had ample opportunities to collaboration time to teachers and support elementary, secondary, and improve, and ensuring that such principals that are, where appropriate, public higher education for FY 2009 decisions are made using rigorous ongoing and job-embedded. Such was greater than or equal to the standards and streamlined, transparent, support might focus on, for example, percentage of the total revenues and fair procedures. gathering, analyzing, and using data; available to the State (as defined in this (D)(3) Ensuring equitable distribution designing instructional strategies for notice) that were used to support of effective teachers and principals: The improvement; differentiating elementary, secondary, and public extent to which the State, in instruction; creating school higher education for FY 2008; and collaboration with its participating environments supportive of data- (ii) The State’s policies lead to LEAs (as defined in this notice), has a informed decisions; designing equitable funding (a) between high-need high-quality plan and ambitious yet instruction to meet the specific needs of LEAs (as defined in this notice) and achievable annual targets to— high-need students (as defined in this other LEAs, and (b) within LEAs,
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between high-poverty schools (as Race to the Top program terms that are leadership, and positive family and defined in this notice) and other not defined in the ARRA (or, by community engagement. schools. reference, in the ESEA). Effective teacher means a teacher (F)(2) Ensuring successful conditions Alternative routes to certification whose students achieve acceptable rates for high-performing charter schools and means pathways to certification that are (e.g., at least one grade level in an other innovative schools: The extent to authorized under the State’s laws or academic year) of student growth (as which— regulations, that allow the establishment defined in this notice). States, LEAs, or (i) The State has a charter school law and operation of teacher and schools must include multiple that does not prohibit or effectively administrator preparation programs in measures, provided that teacher inhibit increasing the number of high- the State, and that have the following effectiveness is evaluated, in significant performing charter schools (as defined characteristics (in addition to standard part, by student growth (as defined in in this notice) in the State, measured (as features such as demonstration of this notice). Supplemental measures set forth in Appendix B) by the subject-matter mastery, and high-quality may include, for example, multiple percentage of total schools in the State instruction in pedagogy and in observation-based assessments of that are allowed to be charter schools or addressing the needs of all students in teacher performance. otherwise restrict student enrollment in the classroom including English Formative assessment means charter schools; language learners and student with assessment questions, tools, and (ii) The State has laws, statutes, disabilities): (a) Can be provided by processes that are embedded in regulations, or guidelines regarding how various types of qualified providers, instruction and are used by teachers and charter school authorizers approve, including both institutions of higher students to provide timely feedback for monitor, hold accountable, reauthorize, education and other providers operating purposes of adjusting instruction to and close charter schools; in particular, independently from institutions of improve learning. Graduation rate means the four-year whether authorizers require that student higher education; (b) are selective in or extended-year adjusted cohort achievement (as defined in this notice) accepting candidates; (c) provide graduation rate as defined by 34 CFR be one significant factor, among others, supervised, school-based experiences in authorization or renewal; encourage 200.19(b)(1). and ongoing support such as effective Highly effective principal means a charter schools that serve student mentoring and coaching; (d) populations that are similar to local principal whose students, overall and significantly limit the amount of for each subgroup, achieve high rates district student populations, especially coursework required or have options to relative to high-need students (as (e.g., one and one-half grade levels in an test out of courses; and (e) upon academic year) of student growth (as defined in this notice); and have closed completion, award the same level of or not renewed ineffective charter defined in this notice). States, LEAs, or certification that traditional preparation schools must include multiple schools; programs award upon completion. (iii) The State’s charter schools measures, provided that principal receive (as set forth in Appendix B) College enrollment refers to the effectiveness is evaluated, in significant equitable funding compared to enrollment of students who graduate part, by student growth (as defined in traditional public schools, and a from high school consistent with 34 this notice). Supplemental measures commensurate share of local, State, and CFR 200.19(b)(1) and who enroll in an may include, for example, high school Federal revenues; institution of higher education (as graduation rates; college enrollment (iv) The State provides charter schools defined in section 101 of the Higher rates; evidence of providing supportive with funding for facilities (for leasing Education Act, Public Law 105–244, 20 teaching and learning conditions, strong facilities, purchasing facilities, or U.S.C. 1001) within 16 months of instructional leadership, and positive making tenant improvements), graduation. family and community engagement; or assistance with facilities acquisition, Common set of K–12 standards means evidence of attracting, developing, and access to public facilities, the ability to a set of content standards that define retaining high numbers of effective share in bonds and mill levies, or other what students must know and be able to teachers. supports; and the extent to which the do and that are substantially identical Highly effective teacher means a State does not impose any facility- across all States in a consortium. A State teacher whose students achieve high related requirements on charter schools may supplement the common standards rates (e.g., one and one-half grade levels that are stricter than those applied to with additional standards, provided that in an academic year) of student growth traditional public schools; and the additional standards do not exceed (as defined in this notice). States, LEAs, (v) The State enables LEAs to operate 15 percent of the State’s total standards or schools must include multiple innovative, autonomous public schools for that content area. measures, provided that teacher (as defined in this notice) other than Effective principal means a principal effectiveness is evaluated, in significant charter schools. whose students, overall and for each part, by student growth (as defined in (F)(3) Demonstrating other significant subgroup, achieve acceptable rates (e.g., this notice). Supplemental measures reform conditions: The extent to which at least one grade level in an academic may include, for example, multiple the State, in addition to information year) of student growth (as defined in observation-based assessments of provided under other State Reform this notice). States, LEAs, or schools teacher performance or evidence of Conditions Criteria, has created, through must include multiple measures, leadership roles (which may include law, regulation, or policy, other provided that principal effectiveness is mentoring or leading professional conditions favorable to education evaluated, in significant part, by student learning communities) that increase the reform or innovation that have growth (as defined in this notice). effectiveness of other teachers in the increased student achievement or Supplemental measures may include, school or LEA. graduation rates, narrowed achievement for example, high school graduation High-minority school is defined by the gaps, or resulted in other important rates and college enrollment rates, as State in a manner consistent with its outcomes. well as evidence of providing Teacher Equity Plan. The State should Final Definitions: The Secretary supportive teaching and learning provide, in its Race to the Top establishes the following definitions for conditions, strong instructional application, the definition used.
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High-need LEA means an LEA (a) that history; and geography; (b) instruction early warning indicators of a student’s serves not fewer than 10,000 children in other subjects and enrichment risk of educational failure. from families with incomes below the activities that contribute to a well- Interim assessment means an poverty line; or (b) for which not less rounded education, including, for assessment that is given at regular and than 20 percent of the children served example, physical education, service specified intervals throughout the by the LEA are from families with learning, and experiential and work- school year, is designed to evaluate incomes below the poverty line. based learning opportunities that are students’ knowledge and skills relative High-need students means students at provided by partnering, as appropriate, to a specific set of academic standards, risk of educational failure or otherwise with other organizations; and (c) and produces results that can be in need of special assistance and teachers to collaborate, plan, and engage aggregated (e.g., by course, grade level, support, such as students who are living in professional development within and school, or LEA) in order to inform in poverty, who attend high-minority across grades and subjects.14 teachers and administrators at the schools (as defined in this notice), who Innovative, autonomous public student, classroom, school, and LEA are far below grade level, who have left schools means open enrollment public levels. school before receiving a regular high schools that, in return for increased Involved LEAs means LEAs that school diploma, who are at risk of not accountability for student achievement choose to work with the State to graduating with a diploma on time, who (as defined in this notice), have the implement those specific portions of the are homeless, who are in foster care, flexibility and authority to define their State’s plan that necessitate full or who have been incarcerated, who have instructional models and associated nearly-full statewide implementation, disabilities, or who are English language curriculum; select and replace staff; such as transitioning to a common set of learners. implement new structures and formats K–12 standards (as defined in this High-performing charter school means for the school day or year; and control notice). Involved LEAs do not receive a a charter school that has been in their budgets. share of the 50 percent of a State’s grant operation for at least three consecutive Instructional improvement systems award that it must subgrant to LEAs in years and has demonstrated overall means technology-based tools and other accordance with section 14006(c) of the success, including (a) substantial strategies that provide teachers, ARRA, but States may provide other progress in improving student principals, and administrators with funding to involved LEAs under the achievement (as defined in this notice); meaningful support and actionable data State’s Race to the Top grant in a and (b) the management and leadership to systemically manage continuous manner that is consistent with the necessary to overcome initial start-up instructional improvement, including State’s application. problems and establish a thriving, such activities as: Instructional Low-minority school is defined by the financially viable charter school. planning; gathering information (e.g., State in a manner consistent with its High-poverty school means, consistent through formative assessments (as Teacher Equity Plan. The State should with section 1111(h)(1)(C)(viii) of the defined in this notice), interim provide, in its Race to the Top ESEA, a school in the highest quartile of assessments (as defined in this notice), application, the definition used. schools in the State with respect to summative assessments, and looking at Low-poverty school means, consistent poverty level, using a measure of student work and other student data); with section 1111(h)(1)(C)(viii) of the poverty determined by the State. analyzing information with the support ESEA, a school in the lowest quartile of High-quality assessment means an of rapid-time (as defined in this notice) schools in the State with respect to assessment designed to measure a reporting; using this information to poverty level, using a measure of student’s knowledge, understanding of, inform decisions on appropriate next poverty determined by the State. and ability to apply, critical concepts instructional steps; and evaluating the Participating LEAs means LEAs that through the use of a variety of item effectiveness of the actions taken. Such choose to work with the State to types and formats (e.g., open-ended systems promote collaborative problem- implement all or significant portions of responses, performance-based tasks). solving and action planning; they may the State’s Race to the Top plan, as Such assessments should enable also integrate instructional data with specified in each LEA’s agreement with measurement of student achievement student-level data such as attendance, the State. Each participating LEA that (as defined in this notice) and student discipline, grades, credit accumulation, receives funding under Title I, Part A growth (as defined in this notice); be of and student survey results to provide will receive a share of the 50 percent of high technical quality (e.g., be valid, a State’s grant award that the State must reliable, fair, and aligned to standards); 14 Research supports the effectiveness of well- subgrant to LEAs, based on the LEA’s incorporate technology where designed programs that expand learning time by a relative share of Title I, Part A appropriate; include the assessment of minimum of 300 hours per school year. (See allocations in the most recent year, in students with disabilities and English Frazier, Julie A.; Morrison, Frederick J. ‘‘The accordance with section 14006(c) of the Influence of Extended-year Schooling on Growth of language learners; and to the extent Achievement and Perceived Competence in Early ARRA. Any participating LEA that does feasible, use universal design principles Elementary School.’’ Child Development. Vol. 69 not receive funding under Title I, Part (as defined in section 3 of the Assistive (2), April 1998, pp. 495–497 and research done by A (as well as one that does) may receive Technology Act of 1998, as amended, 29 Mass2020.) Extending learning into before- and funding from the State’s other 50 after-school hours can be difficult to implement U.S.C. 3002) in development and effectively, but is permissible under this definition percent of the grant award, in administration. with encouragement to closely integrate and accordance with the State’s plan. Increased learning time means using coordinate academic work between in-school and Persistently lowest-achieving schools a longer school day, week, or year out-of school. (See James-Burdumy, Susanne; means, as determined by the State: (i) Dynarski, Mark; Deke, John. ‘‘When Elementary schedule to significantly increase the Schools Stay Open Late: Results from The National Any Title I school in improvement, total number of school hours to include Evaluation of the 21st Century Community Learning corrective action, or restructuring that additional time for (a) instruction in Centers Program.’’ http://www.mathematica-mpr. (a) Is among the lowest-achieving five core academic subjects, including com/publications/redirect_PubsDB.asp? percent of Title I schools in strSite=http://epa.sagepub.com/cgi/content/ English; reading or language arts; abstract/29/4/296 Educational Evaluation and improvement, corrective action, or mathematics; science; foreign languages; Policy Analysis, Vol. 29 (4), December 2007, restructuring or the lowest-achieving civics and government; economics; arts; Document No. PP07–121.) five Title I schools in improvement,
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corrective action, or restructuring in the 6401(e)(2)(D) of that Act): (1) A unique budgetary impacts of entitlement grants, State, whichever number of schools is statewide student identifier that does user fees, or loan programs or the rights greater; or (b) Is a high school that has not permit a student to be individually and obligations of recipients thereof; or had a graduation rate as defined in 34 identified by users of the system; (2) (4) raise novel legal or policy issues CFR 200.19(b) that is less than 60 student-level enrollment, demographic, arising out of legal mandates, the percent over a number of years; and (ii) and program participation information; President’s priorities, or the principles Any secondary school that is eligible (3) student-level information about the set forth in the Executive Order. for, but does not receive, Title I funds points at which students exit, transfer Pursuant to the Executive Order, it has that (a) Is among the lowest-achieving in, transfer out, drop out, or complete been determined that this regulatory five percent of secondary schools or the P–16 education programs; (4) the action will have an annual effect on the lowest-achieving five secondary schools capacity to communicate with higher economy of more than $100 million in the State that are eligible for, but do education data systems; (5) a State data because the amount of government not receive, Title I funds, whichever audit system assessing data quality, transfers provided through the Race to number of schools is greater; or (b) Is a validity, and reliability; (6) yearly test the Top Fund will exceed that amount. high school that has had a graduation records of individual students with Therefore, this action is ‘‘economically rate as defined in 34 CFR 200.19(b) that respect to assessments under section significant’’ and subject to OMB review is less than 60 percent over a number of 1111(b) of the ESEA (20 U.S.C. 6311(b)); under section 3(f)(1) of the Executive years. (7) information on students not tested Order. To identify the lowest-achieving by grade and subject; (8) a teacher The potential costs associated with schools, a State must take into account identifier system with the ability to this regulatory action are those resulting both (i) The academic achievement of match teachers to students; (9) student- from statutory requirements and those the ‘‘all students’’ group in a school in level transcript information, including we have determined as necessary for terms of proficiency on the State’s information on courses completed and administering this program effectively assessments under section 1111(b)(3) of grades earned; (10) student-level college and efficiently. the ESEA in reading/language arts and readiness test scores; (11) information In assessing the potential costs and mathematics combined; and (ii) The regarding the extent to which students benefits—both quantitative and school’s lack of progress on those transition successfully from secondary qualitative—of this regulatory action, assessments over a number of years in school to postsecondary education, we have determined that the benefits of the ‘‘all students’’ group. including whether students enroll in the final priorities, requirements, Rapid-time, in reference to reporting remedial coursework; and (12) other definitions, and criteria justify the costs. and availability of locally-collected information determined necessary to We have determined, also, that this school- and LEA-level data, means that address alignment and adequate regulatory action does not unduly data are available quickly enough to preparation for success in interfere with State, local, and tribal inform current lessons, instruction, and postsecondary education. governments in the exercise of their related supports. This notice does not preclude us from governmental functions. Student achievement means— proposing additional priorities, (a) For tested grades and subjects: (1) Response to comments on cost/benefit requirements, definitions, or selection A student’s score on the State’s analysis: criteria, subject to meeting applicable assessments under the ESEA; and, as rulemaking requirements. Administrative Burdens and Costs appropriate, (2) other measures of student learning, such as those Note: This notice does not solicit Comment: While one commenter described in paragraph (b) of this applications. In any year in which we choose noted that Race to the Top would definition, provided they are rigorous to use these priorities, requirements, provide significant funding to pay for and comparable across classrooms. definitions, and selection criteria, we invite reform plans, a second commenter applications through a notice in the Federal stated that Race to the Top would not (b) For non-tested grades and subjects: Register. Alternative measures of student learning provide enough money to cover State administrative costs, while another and performance such as student scores Executive Order 12866 on pre-tests and end-of-course tests; described the NPP’s requirements as student performance on English Under Executive Order 12866, the overly burdensome and bureaucratic. language proficiency assessments; and Secretary must determine whether this One commenter recommended that the other measures of student achievement regulatory action is ‘‘significant’’ and Department reduce the number of that are rigorous and comparable across therefore subject to the requirements of criteria and the detail in each because classrooms. the Executive Order and subject to of the administrative and staff burdens Student growth means the change in review by OMB. Section 3(f) of involved in completing an application. student achievement (as defined in this Executive Order 12866 defines a Two commenters said the NPP estimate notice) for an individual student ‘‘significant regulatory action’’ as an of time required to complete Race to the between two or more points in time. A action likely to result in a rule that may Top applications and data collection State may also include other measures (1) have an annual effect on the was too low. Two other commenters that are rigorous and comparable across economy of $100 million or more, or said that the Department should work to classrooms. adversely affect a sector of the economy, ensure an ‘‘integrated and coordinated Total revenues available to the State productivity, competition, jobs, the approach’’ to requesting data and means either (a) projected or actual total environment, public health or safety, or information with this and other State revenues for education and other State, local or tribal governments, or programs and was concerned that the purposes for the relevant year; or (b) communities in a material way (also current number of requirements might projected or actual total State referred to as an ‘‘economically discourage States from applying. Three appropriations for education and other significant’’ rule); (2) create serious commenters recommended that States purposes for the relevant year. inconsistency or otherwise interfere include LEAs in developing their Race America COMPETES Act elements with an action taken or planned by to the Top plans to improve the means (as specified in section another agency; (3) materially alter the likelihood of successful
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implementation, control costs, and coordinate the use of funds in order to Summary of Costs and Benefits increase benefits. make the most efficient and effective The Department believes that the final Discussion: The Department agrees use of limited resources and will priorities, requirements, definitions, and that sufficient funds will be available continue to consider States’ requests for selection criteria will not impose through the Race to the Top program, waivers that are permissible under significant costs on States, or on the other Federal education programs, and current Federal statutes and regulations. LEAs and other entities that will receive State and local education resources to Changes: None. assistance through the Race to the Top successfully implement Race to the Top Fund. As discussed elsewhere, this final plans. The Department also agrees that Impact on State Pension Plans regulatory action is intended to create a involving LEAs in developing Race to Comment: One commenter stated that framework for the award of the Top plans will result in stronger, approximately $4 billion in support of a potential cost of this competition more cost-effective State plans. As for State and local efforts to implement would be the reduced teacher claims that Race to the Top critical educational reforms and to contributions to the public pension plan requirements are overly burdensome making substantial gains in student if charter schools continue to multiply and bureaucratic, the Department achievement, closing achievement gaps, in the State. believes that each of the criteria and improving high school graduation rates, other requirements included in this Discussion: The Department is not in and ensuring student preparation for final notice are essential for successfully a position to consider the potential success in college and careers. Without evaluating Race to the Top applications, impact of increasing numbers of charter promulgation of priorities, appropriately funding winning schools on contributions to teacher requirements, definitions, and criteria applications, and ensuring pension plans. However, we note that for the Race to the Top competition, the accountability for the use of Race to the charter schools are public schools, and Department would not have clear and Top funds. The Department also to the extent that charter school teachers defensible criteria for making very large believes that its estimate of the time are eligible to contribute to such grants to States. required to complete Race to the Top pension plans, it seems reasonable that The Department believes that the applications is reasonably accurate they would do so. costs imposed on States by the final across the range of circumstances Changes: None. priorities, requirements, definitions, and experienced by different States and selection criteria will be limited to the LEAs. It is possible that some States will Need for Federal Regulatory Action paperwork burden discussed elsewhere be deterred from applying for a Race to in this notice. The benefits conveyed on the Top grant because of the These final priorities, requirements, a State through its receipt of a grant will comprehensive nature of the program’s definitions, and criteria are needed to greatly exceed those costs. In addition, requirements, but this is true of other implement the Race to the Top program. even States that apply but are voluntary competitive grant programs. The Secretary does not believe that the unsuccessful in the competition may The Department is working to statute, by itself, provides a sufficient derive benefits, as the process of streamline definitions and data level of detail to ensure that Race to the working with LEAs and other collection across all ARRA programs as Top truly serves as a mechanism for stakeholders on the State application much as possible to minimize driving significant education reform in may help accelerate the pace of application and administrative burdens the States. The authorizing language is education reforms in the State. on States and LEAs. Finally, winning very brief, and we believe the Congress States will have considerable flexibility likely expected the Secretary to augment Accounting Statement to use the 50 percent of Race to the Top this language, through rulemaking, in As required by OMB Circular A–4 funds that are not allocated to order to give greater meaning to the (available at http:// participating LEAs through the Title I, statutory provisions. Additionally, the www.Whitehouse.gov/omb/Circulars/ Part A formula to cover a wide range of statute expressly provides the Secretary a004/a-4.pdf), in the following table, we costs related to administering awards, the authority to require States to include have prepared an accounting statement including grant oversight, monitoring, in their application such information as showing the classification of the evaluation, data collection, and other the Secretary may reasonably require expenditures associated with the activities. and to determine which States receive provisions of this regulatory action. This Changes: None. grants on the basis of other criteria as table provides our best estimate of the Using Other Federal Funding the Secretary determines appropriate. Federal payments to be made to States Comment: One commenter suggested In the absence of specific criteria for under this program as a result of this that the Department remind States of the Race to the Top grants, the Department regulatory action. Expenditures are flexibility of some Federal funding would use the general criteria in 34 CFR classified as transfers to States. sources and encourage States to describe 75.210 of the Education Department TABLE—ACCOUNTING STATEMENT any Federal barriers to implementing General Administrative Regulations in their State plans and to request waivers selecting States to receive grants. The CLASSIFICATION OF ESTIMATED EX- of those provisions. Secretary does not believe the use of PENDITURES Discussion: The final notice those general criteria would be encourages States, in criterion appropriate for the Race to the Top Category Transfers (in millions) (A)(2)(i)(d), to coordinate, reallocate, or competition, because they do not focus Annual Monetized $3,956. repurpose other Federal, State, and local on the educational reforms that States Transfers. sources ‘‘where feasible’’ to align such must be implementing in order to From Whom to Whom Federal Government resources with Race to the Top goals. In receive a Race to the Top grant, on the to States. response to the commenter, we note that specific uses of funds under Race to the such waivers and flexibilities are often Top, or on the plans that the Secretary As previously explained, ARRA limited by statute. However, the believes States should develop for their provides approximately $4.3 billion for Department fully supports efforts to Race to the Top grants. the Race to the Top Fund (referred to in
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the statute as State Incentive Grants). In (B)(3) Supporting the transition to Order relies on processes developed by this notice, we require additional enhanced standards and high-quality State and local governments for specific priorities, requirements, assessments; coordination and review of proposed definitions, and criteria regarding the (C)(1) Fully implementing a statewide Federal financial assistance. applications that individual States longitudinal data system; This document provides early submit for approximately $4 billion of (C)(2) Accessing and using State data; notification of our specific plans and Race to the Top funds. At a later date, (C)(3) Using data to improve actions for this program. we may announce a competition for a instruction; Accessible Format: Individuals with separate Race to the Top Assessment (D)(1) Providing high-quality disabilities can obtain this document in Program, for approximately $350 pathways for aspiring teachers and an accessible format (e.g., braille, large million, to support the development of principals; print, audiotape, or computer diskette) assessments by consortia of States. (D)(2) Improving teacher and on request to the program contact principal effectiveness based on person listed under FOR FURTHER Paperwork Reduction Act of 1995 performance; INFORMATION CONTACT. The application requirements and (D)(3) Ensuring equitable distribution Electronic Access to This Document: criteria finalized in this notice will of effective teachers and principals; You can view this document, as well as require the collection of information (D)(4) Improving the effectiveness of all other documents of this Department that is subject to review by the Office of teacher and principal preparation published in the Federal Register, in Management and Budget (OMB) under programs; text or Adobe Portable Document the Paperwork Reduction Act of 1995 (D)(5) Providing effective support to Format (PDF) on the Internet at the (44 U.S.C. 3501–3520). The Department teachers and principals; following site: http://www.ed.gov/news/ has received emergency approval for the (E)(1) Intervening in the lowest- fedregister. To use PDF you must have information collections described below achieving schools and LEAs; Adobe Acrobat Reader, which is under Information Collection Reference (E)(2) Turning around the lowest- available free at this site. Number 200910–1810–004. achieving schools; (F)(1) Making education funding a Dated: November 10, 2009. Application Requirements priority; Arne Duncan, There are seven application (F)(2) Ensuring successful conditions Secretary of Education. for high-performing charter schools and requirements that States must meet Appendix A Evidence and Performance other innovative schools; when submitting their applications: Measures (a) Required signatures. (F)(3) Demonstrating other significant (b) Progress in the four education reform conditions. A. State Success Factors reform areas (as described in criterion (Please see the ‘‘Selection Criteria’’ (A)(1) Articulating State’s Education (A)(3)(i)). section for detailed descriptions.) (c) The State’s proposed budget (as We estimate that each SEA would Reform Agenda and LEAs’ Participation described in criterion (A)(2)(i)(d)), spend approximately 681 hours of staff in it including how it will (1) Achieve its time to address the application Evidence targets (as described in criterion requirements and criteria, prepare the Evidence for (A)(1)(ii): (A)(1)(iii)) and (2) give priority to high- application, and obtain necessary • An example of the State’s standard need LEAs. clearances. This estimate has increased Participating LEA MOU, and (d) Required information for State slightly from the estimate of 642 hours description of variations used, if any. Reform Conditions Criteria. in the NPP due to changes in the • The completed summary table (e) Required information for Reform criteria. The total number of hours for indicating which specific portions of the Plan Criteria. all 52 SEAs is an estimated 35,412 hours State’s plan each LEA is committed to (f) Attorney General certification. (52 SEAs (the 50 States plus the District (g) Required information for implementing, and relevant summary of Columbia and Puerto Rico) times 681 statistics (see Summary Table for addressing issues relating to hours equals 35,412 hours). We estimate assessments required under the ESEA or (A)(1)(ii)(b)). the average total cost per hour of the • The completed summary table subgroups. State-level staff who carry out this work (Please see the Application indicating which LEA leadership to be $30.00 an hour. The total Requirements section for detailed signatures have been obtained (see estimated cost for all States would be descriptions.) Summary Table for (A)(1)(ii)(c)). $1,062,360 ($30.00 × 35,412 hours = Evidence for (A)(1)(iii): Selection Criteria $1,062,360). • The completed summary table There are 19 criteria that States may Regulatory Flexibility Act indicating the numbers and percentages address when submitting their Certification: The Secretary certifies that of participating LEAs, schools, K–12 applications. These are— this regulatory action will not have a students, and students in poverty (see (A)(1) Articulating State’s education significant economic impact on a Summary Table for (A)(1)(iii)). reform agenda and LEAs’ participation substantial number of small entities. • Tables and graphs that show the in it; The Secretary makes this certification State’s goals, overall and by subgroup, (A)(2) Building strong statewide because the only entities eligible to requested in the criterion, together with capacity to implement, scale up, and apply for grants are States, and States the supporting narrative. In addition, sustain proposed plans; are not small entities. describe what the goals would look like (A)(3) Demonstrating significant Intergovernmental Review: This were the State not to receive an award progress in raising achievement and program is subject to Executive Order under this program. closing gaps; 12372 and the regulations in 34 CFR Evidence for (A)(1)(ii) and (A)(1)(iii): (B)(1) Developing and adopting Part 79. One of the objectives of the • The completed detailed table, by common standards; Executive Order is to foster an LEA, that includes the information (B)(2) Developing and implementing intergovernmental partnership and a requested in the criterion (see Detailed common, high-quality assessments; strengthened federalism. The Executive Table for (A)(1)).
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Performance Measures State’s plan, current progress, and (C)(2) Accessing and Using State Data • None required. timeframe for adoption. Evidence For Phase 2 applicants: (A)(2) Building Strong Statewide • Any supporting evidence the State Capacity to Implement, Scale up, and • Evidence that the State has adopted believes will be helpful to peer Sustain Proposed Plans the standards. Or, if the State has not yet reviewers. adopted the standards, a description of Evidence the legal process in the State for Performance Measures Evidence for (A)(2)(i)(d): adopting standards and the State’s plan, • Optional. • The State’s budget, as completed in current progress, and timeframe for (C)(3) Using Data To Improve Section XI of the application. The adoption. narrative that accompanies and explains Instruction the budget and how it connects to the Performance Measures Evidence State’s plan, as completed in Section XI • None required. • Any supporting evidence the State of the application. believes will be helpful to peer Evidence for (A)(2)(ii): (B)(2) Developing and Implementing reviewers. • A summary in the narrative of the Common, High-quality Assessments statements or actions and inclusion of Performance Measures key statements or actions in the Evidence • Optional. Appendix. Evidence for (B)(2): (D) Great Teachers and Leaders Performance Measures • A copy of the Memorandum of • None required. Agreement, executed by the State, (D)(1) Providing High-Quality Pathways showing that it is part of a consortium for Aspiring Teachers and Principals (A)(3) Demonstrating Significant that intends to develop high-quality Evidence for (D)(1)(i): Progress in Raising Achievement and assessments (as defined in this notice) • A description of the State’s Closing Gaps aligned with the consortium’s common applicable laws, statutes, regulations, or Evidence set of K–12 standards; or documentation other relevant legal documents, Evidence for (A)(3)(ii): that the State’s consortium has applied, including information on the elements NAEP and ESEA results since at least or intends to apply, for a grant through of the State’s alternative routes (as 2003. Include in the Appendix all the the separate Race to the Top Assessment described in the alternative routes to data requested in the criterion as a Program (to be described in a certification definition in this notice). resource for peer reviewers for each year subsequent notice); or other evidence of Evidence for (D)(1)(ii): in which a test was given or data was the State’s plan to develop and adopt • A list of the alternative certification collected. Note that this data will be common, high-quality assessments (as programs operating in the State under used for reference only and can be in defined in this notice). the State’s alternative routes to raw format. In the narrative, provide the • The number of States participating certification (as defined in this notice), analysis of this data and any tables or in the assessment consortium and the and for each: Æ graphs that best support the narrative. list of these States. The elements of the program (as described in the alternative routes to Performance Measures Performance Measures certification definition in this notice). • None required. Æ The number of teachers and • None required. principals that successfully completed (B) Standards and Assessments (B)(3) Supporting the Transition To each program in the previous academic (B)(1) Developing and Adopting Enhanced Standards and High-Quality year. Common Standards Assessments Æ The total number of teachers and Evidence principals certified statewide in the Evidence previous academic year. Evidence for (B)(1)(i): • • A copy of the Memorandum of Any supporting evidence the State Performance Measures believes will be helpful to peer Agreement, executed by the State, • None required. showing that it is part of a standards reviewers. (D)(2) Improving Teacher and Principal consortium. Performance Measures • A copy of the final standards or, if Effectiveness Based on Performance the standards are not yet final, a copy • Optional. Evidence of the draft standards and anticipated • date for completing the standards. (C) Data Systems To Support Instruction Any supporting evidence the State • Documentation that the standards (C)(1) Fully Implementing a Statewide believes will be helpful to peer are or will be internationally Longitudinal Data System reviewers. benchmarked and that, when well- Performance Measures implemented, will help to ensure that Evidence General goals to be provided at time students are prepared for college and • Documentation for each of the of application, including baseline data careers. America COMPETES Act elements (as • The number of States participating and annual targets: defined in this notice) that is included in the standards consortium and the list • (D)(2)(i) Percentage of participating in the State’s statewide longitudinal of these States. LEAs that measure student growth (as Evidence for (B)(1)(ii): data system. defined in this notice). • For Phase 1 applicants: Performance Measures (D)(2)(ii) Percentage of participating • A description of the legal process in LEAs with qualifying evaluation the State for adopting standards, and the • None required. systems for teachers.
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• (D)(2)(ii) Percentage of participating (D)(3) Ensuring Equitable Distribution of minority, or both (as defined in this LEAs with qualifying evaluation Effective Teachers and Principals notice). • systems for principals. Evidence Total number of principals leading • (D)(2)(iv) Percentage of schools that are low-poverty, low- Evidence for (D)(3)(i): minority, or both (as defined in this participating LEAs with qualifying • evaluation systems that are used to Definitions of high-minority and notice). inform: low-minority schools as defined by the Data to be requested of grantees in the State for the purposes of the State’s Æ (D)(2)(iv)(a) Developing teachers future: Teacher Equity Plan. • and principals. Number of teachers and principals Æ (D)(2)(iv)(b) Compensating teachers Performance Measures in schools that are high-poverty, high- and principals. minority, or both (as defined in this Æ (D)(2)(iv)(b) Promoting teachers and Note: All information below is requested notice) who were evaluated as highly principals. for Participating LEAs. effective (as defined in this notice) in Æ (D)(2)(iv)(b) Retaining effective Performance Measures for (D)(3)(i): the prior academic year. • Number of teachers and principals teachers and principals. General goals to be provided at time in schools that are high-poverty, high- Æ (D)(2)(iv)(c) Granting tenure and/or of application, including baseline data minority, or both (as defined in this full certification (where applicable) to and annual targets: • notice) who were evaluated as teachers and principals. Percentage of teachers in schools Æ that are high-poverty, high-minority, or ineffective in the prior academic year. (D)(2)(iv)(d) Removing ineffective • Number of teachers and principals tenured and untenured teachers and both (as defined in this notice) who are highly effective (as defined in this in schools that are low-poverty, low- principals. minority, or both (as defined in this General data to be provided at time of notice). • Percentage of teachers in schools notice) who were evaluated as highly application, including baseline data: effective (as defined in this notice) in • that are low-poverty, low-minority, or Total number of participating LEAs. the prior academic year. • both (as defined in this notice) who are Total number of principals in highly effective (as defined in this • Number of teachers and principals participating LEAs. notice). in schools that are low-poverty, low- • Total number of teachers in • Percentage of teachers in schools minority, or both (as defined in this participating LEAs. that are high-poverty, high-minority, or notice) who were evaluated as Data to be requested of grantees in the both (as defined in this notice) who are ineffective in the prior academic year. future: ineffective. Performance Measures for (D)(3)(ii): • (D)(2)(ii) Number of teachers and • Percentage of teachers in schools General goals to be provided at time principals in participating LEAs with that are low-poverty, low-minority, or of application, including baseline data qualifying evaluation systems. both (as defined in this notice) who are and annual targets: • (D)(2)(iii) Number of teachers and ineffective. • Percentage of mathematics teachers principals in participating LEAs with • Percentage of principals leading who were evaluated as effective or qualifying evaluation systems who were schools that are high-poverty, high- better. • evaluated as effective or better in the minority, or both (as defined in this Percentage of science teachers who prior academic year. notice) who are highly effective (as were evaluated as effective or better. • • (D)(2)(iii) Number of teachers and defined in this notice). Percentage of special education principals in participating LEAs with • Percentage of principals leading teachers who were evaluated as effective schools that are low-poverty, low- or better. qualifying evaluation systems who were • evaluated as ineffective in the prior minority, or both (as defined in this Percentage of teachers in language academic year. notice) who are highly effective (as instruction educational programs who • (D)(2)(iv)(b) Number of teachers and defined in this notice). were evaluated as effective or better. • General data to be provided at time of principals in participating LEAs with Percentage of principals leading application, including baseline data: qualifying evaluation systems whose schools that are high-poverty, high- • Total number of mathematics evaluations were used to inform minority, or both (as defined in this notice) who are ineffective. teachers. compensation decisions in the prior • • Total number of science teachers. academic year. Percentage of principals leading schools that are low-poverty, low- • Total number of special education • (D)(2)(iv)(b) Number of teachers and minority, or both (as defined in this teachers. principals in participating LEAs with • notice) who are ineffective. Total number of teachers in qualifying evaluation systems who were General data to be provided at time of language instruction educational evaluated as effective or better and were application, including baseline data: programs. retained in the prior academic year. • Data to be requested of grantees in the • Total number of schools that are (D)(2)(iv)(c) Number of teachers in high-poverty, high-minority, or both (as future: participating LEAs with qualifying defined in this notice). • Number of mathematics teachers in evaluation systems who were eligible • Total number of schools that are participating LEAs who were evaluated for tenure in the prior academic year. low-poverty, low-minority, or both (as as effective or better in the prior • (D)(2)(iv)(c) Number of teachers in defined in this notice). academic year. participating LEAs with qualifying • Total number of teachers in schools • Number of science teachers in evaluation systems whose evaluations that are high-poverty, high-minority, or participating LEAs who were evaluated were used to inform tenure decisions in both (as defined in this notice). as effective or better in the prior the prior academic year. • Total number of teachers in schools academic year. • (D)(2)(iv)(d) Number of teachers and that are low-poverty, low-minority, or • Number of special education principals in participating LEAs who both (as defined in this notice). teachers in participating LEAs who were were removed for being ineffective in • Total number of principals leading evaluated as effective or better in the the prior academic year. schools that are high-poverty, high- prior academic year.
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• Number of teachers in language (D)(5) Providing Effective Support to • A description of the State’s instruction educational programs in Teachers and Principals applicable laws, statutes, regulations, or participating LEAs who were evaluated Evidence other relevant legal documents. as effective or better in the prior • The number of charter schools academic year. • Any supporting evidence the State allowed under State law and the believes will be helpful to peer percentage this represents of the total (D)(4) Improving the Effectiveness of reviewers. number of schools in the State. Teacher and Principal Preparation • The number and types of charter Programs Performance Measures schools currently operating in the State. Evidence • Optional. Evidence for (F)(2)(ii): • A description of the State’s • Any supporting evidence the State (E) Turning Around the Lowest- approach to charter school believes will be helpful to peer Achieving Schools accountability and authorization, and a reviewers. (E)(1) Intervening in the Lowest- description of the State’s applicable laws, statutes, regulations, or other Performance Measures Achieving Schools and LEAs relevant legal documents. Evidence General goals to be provided at time • For each of the last five years: Æ of application, including baseline data Evidence for (E)(1): The number of charter school and annual targets: • A description of the State’s applications made in the State. Æ The number of charter school • Percentage of teacher preparation applicable laws, statutes, regulations, or other relevant legal documents. applications approved. programs in the State for which the Æ The number of charter school public can access data on the Performance Measures applications denied and reasons for the achievement and growth (as defined in • None required. denials (academic, financial, low this notice) of the graduates’ students. enrollment, other). • Percentage of principal preparation (E)(2) Turning Around the Lowest- Æ The number of charter schools programs in the State for which the Achieving Schools closed (including charter schools that public can access data on the Evidence were not reauthorized to operate). achievement and growth (as defined in Æ The reasons for the closures or non- this notice) of the graduates’ students. • The State’s historic performance on renewals (academic, financial, low school turnaround, as evidenced by the General data to be provided at time of enrollment, other). total number of persistently lowest- Evidence for (F)(2)(iii): application, including baseline data: achieving schools (as defined in this • A description of the State’s • Total number of teacher notice) that States or LEAs attempted to applicable statutes, regulations, or other credentialing programs in the State. turn around in the last five years, the relevant legal documents. • • Total number of principal approach used, and the results and A description of the State’s credentialing programs in the State. lessons learned to date. approach to charter school funding, the amount of funding passed through to • Total number of teachers in the Performance Measures charter schools per student, and how State. • The number of schools for which those amounts compare with traditional • Total number of principals in the one of the four school intervention public school per-student funding State. models (described in Appendix C) will allocations. Data to be requested of grantees in the be initiated each year. Evidence for (F)(2)(iv): future: • A description of the State’s (F) General • Number of teacher credentialing applicable statutes, regulations, or other relevant legal documents. programs in the State for which the (F)(1) Making Education Funding a • A description of the statewide information (as described in the Priority facilities supports provided to charter criterion) is publicly reported. Evidence schools, if any. • Number of teachers prepared by Evidence for (F)(1)(i): Evidence for (F)(2)(v): each credentialing program in the State • A description of how the State • Financial data to show whether and for which the information (as described enables LEAs to operate innovative, to what extent expenditures, as a in the criterion) is publicly reported. autonomous public schools (as defined percentage of the total revenues • in this notice) other than charter Number of principal credentialing available to the State (as defined in this schools. programs in the State for which the notice), increased, decreased, or information (as described in the remained the same. Performance Measures criterion) is publicly reported. Evidence for (F)(1)(ii): • None required. • Number of principals prepared by • Any supporting evidence the State each credentialing program in the State believes will be helpful to peer (F)(3) Demonstrating Other Significant for which the information (as described reviewers. Reform Conditions in the criterion) is publicly reported. Evidence Performance Measures • Number of teachers in the State • Evidence for (F)(3): whose data are aggregated to produce None required. • A description of the State’s other publicly available reports on the State’s (F)(2) Ensuring Successful Conditions applicable key education laws, statutes, credentialing programs. for High-Performing Charter Schools regulations, or relevant legal documents. • Number of principals in the State and Other Innovative Schools Performance Measures whose data are aggregated to produce Evidence • publicly available reports on the State’s None required. credentialing programs. Evidence for (F)(2)(i): BILLING CODE 4000–01–P
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BILLING CODE 4000–01–C (ii) Using locally adopted program and designed with school staff Appendix C School Intervention competencies to measure the to ensure that they are equipped to Models effectiveness of staff who can work facilitate effective teaching and learning within the turnaround environment to There are four school intervention and have the capacity to successfully meet the needs of students, models referred to in Selection Criterion implement school reform strategies; (E)(2): Turnaround model, restart model, (A) Screen all existing staff and rehire (v) Adopt a new governance structure, school closure, or transformation model. no more than 50 percent; and which may include, but is not limited Each is described below. (B) Select new staff; to, requiring the school to report to a (a) Turnaround model. (1) A (iii) Implement such strategies as new ‘‘turnaround office’’ in the LEA or turnaround model is one in which an financial incentives, increased SEA, hire a ‘‘turnaround leader’’ who LEA must— opportunities for promotion and career reports directly to the Superintendent or (i) Replace the principal and grant the growth, and more flexible work Chief Academic Officer, or enter into a conditions that are designed to recruit, principal sufficient operational multi-year contract with the LEA or SEA place, and retain staff with the skills flexibility (including in staffing, to obtain added flexibility in exchange necessary to meet the needs of the calendars/time, and budgeting) to for greater accountability; implement fully a comprehensive students in the turnaround school; approach in order to substantially (iv) Provide staff with ongoing, high- (vi) Use data to identify and improve student achievement outcomes quality, job-embedded professional implement an instructional program and increase high school graduation development that is aligned with the that is research-based and ‘‘vertically rates; school’s comprehensive instructional aligned’’ from one grade to the next as
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well as aligned with State academic ongoing collections of professional order to meet the academic needs of standards; practice reflective of student individual students. (vii) Promote the continuous use of achievement and increased high-school (ii) Permissible activities. An LEA student data (such as from formative, graduations rates; and may also implement comprehensive interim, and summative assessments) to (2) Are designed and developed with instructional reform strategies, such inform and differentiate instruction in teacher and principal involvement; as— order to meet the academic needs of (C) Identify and reward school (A) Conducting periodic reviews to individual students; leaders, teachers, and other staff who, in ensure that the curriculum is being (viii) Establish schedules and implementing this model, have implemented with fidelity, is having the implement strategies that provide increased student achievement and intended impact on student increased learning time (as defined in high-school graduation rates and achievement, and is modified if this notice); and identify and remove those who, after ineffective; (ix) Provide appropriate social- ample opportunities have been provided (B) Implementing a schoolwide emotional and community-oriented for them to improve their professional ‘‘response-to-intervention’’ model; services and supports for students. practice, have not done so; (C) Providing additional supports and (2) A turnaround model may also (D) Provide staff with ongoing, high- professional development to teachers implement other strategies such as— quality, job-embedded professional and principals in order to implement (i) Any of the required and development (e.g., regarding subject- effective strategies to support students permissible activities under the specific pedagogy, instruction that with disabilities in the least restrictive transformation model; or reflects a deeper understanding of the environment and to ensure that limited (ii) A new school model (e.g., themed, community served by the school, or English proficient students acquire dual language academy). differentiated instruction) that is aligned language skills to master academic (b) Restart model. A restart model is with the school’s comprehensive content; one in which an LEA converts a school instructional program and designed (D) Using and integrating technology- or closes and reopens a school under a with school staff to ensure they are based supports and interventions as part charter school operator, a charter equipped to facilitate effective teaching of the instructional program; and management organization (CMO), or an and learning and have the capacity to (E) In secondary schools— education management organization successfully implement school reform (EMO) that has been selected through a (1) Increasing rigor by offering strategies; and opportunities for students to enroll in rigorous review process. (A CMO is a (E) Implement such strategies as non-profit organization that operates or advanced coursework (such as financial incentives, increased Advanced Placement or International manages charter schools by centralizing opportunities for promotion and career or sharing certain functions and Baccalaureate; or science, technology, growth, and more flexible work engineering, and mathematics courses, resources among schools. An EMO is a conditions that are designed to recruit, for-profit or non-profit organization that especially those that incorporate place, and retain staff with the skills rigorous and relevant project-, provides ‘‘whole-school operation’’ necessary to meet the needs of the services to an LEA.) A restart model inquiry-, or design-based contextual students in a transformation school. learning opportunities), early-college must enroll, within the grades it serves, (ii) Permissible activities. An LEA high schools, dual enrollment programs, any former student who wishes to may also implement other strategies to or thematic learning academies that attend the school. develop teachers’ and school leaders’ prepare students for college and careers, (c) School closure. School closure effectiveness, such as— occurs when an LEA closes a school and (A) Providing additional including by providing appropriate enrolls the students who attended that compensation to attract and retain staff supports designed to ensure that low- school in other schools in the LEA that with the skills necessary to meet the achieving students can take advantage are higher achieving. These other needs of the students in a of these programs and coursework; schools should be within reasonable transformation school; (2) Improving student transition from proximity to the closed school and may (B) Instituting a system for measuring middle to high school through summer include, but are not limited to, charter changes in instructional practices transition programs or freshman schools or new schools for which resulting from professional academies; achievement data are not yet available. development; or (3) Increasing graduation rates (d) Transformation model. A (C) Ensuring that the school is not through, for example, credit-recovery transformation model is one in which required to accept a teacher without the programs, re-engagement strategies, an LEA implements each of the mutual consent of the teacher and smaller learning communities, following strategies: principal, regardless of the teacher’s competency-based instruction and (1) Developing and increasing teacher seniority. performance-based assessments, and and school leader effectiveness. (2) Comprehensive instructional acceleration of basic reading and (i) Required activities. The LEA reform strategies. mathematics skills; or must— (i) Required activities. The LEA (4) Establishing early-warning systems (A) Replace the principal who led the must— to identify students who may be at risk school prior to commencement of the (A) Use data to identify and of failing to achieve to high standards or transformation model; implement an instructional program graduate. (B) Use rigorous, transparent, and that is research-based and ‘‘vertically (3) Increasing learning time and equitable evaluation systems for aligned’’ from one grade to the next as creating community-oriented schools. teachers and principals that— well as aligned with State academic (i) Required activities. The LEA (1) Take into account data on student standards; and must— growth (as defined in this notice) as a (B) Promote the continuous use of (A) Establish schedules and significant factor as well as other factors student data (such as from formative, implement strategies that provide such as multiple observation-based interim, and summative assessments) to increased learning time (as defined in assessments of performance and inform and differentiate instruction in this notice); and
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(B) Provide ongoing mechanisms for Appendix D Participating LEA Race to the Top application an LEA family and community engagement. Memorandum of Understanding must agree to implement all or (ii) Permissible activities. An LEA significant portions of the State’s reform Background may also implement other strategies that plans.) extend learning time and create Participating LEAs (as defined in this If a State is awarded a Race to the Top community-oriented schools, such as— notice) in a State’s Race to the Top plans grant, the participating LEAs (as defined (A) Partnering with parents and are required to enter into a in this notice) will have up to 90 days parent organizations, faith- and Memorandum of Understanding (MOU) to complete final scopes of work (which community-based organizations, health or other binding agreement with the could be attached to the model MOU as clinics, other State or local agencies, State that specifies the scope of the Exhibit II), which must contain detailed and others to create safe school work being implemented by the work plans that are consistent with the environments that meet students’ social, participating LEA (as defined in this preliminary scope of work and with the emotional, and health needs; notice). State’s grant application, and should To support States in working (B) Extending or restructuring the include the participating LEA’s (as efficiently with LEAs to determine school day so as to add time for such defined in this notice) specific goals, which LEAs will participate in the strategies as advisory periods that build activities, timelines, budgets, key State’s Race to the Top application, the relationships between students, faculty, personnel, and annual targets for key U.S. Department of Education has and other school staff; performance measures. (C) Implementing approaches to produced a model MOU, which is attached. This model MOU may serve as (iii) Signatures: The signatures improve school climate and discipline, demonstrate (a) an acknowledgement of such as implementing a system of a template for States; however, States are not required to use it. They may use the relationship between the LEA and positive behavioral supports or taking the State, and (b) the strength of the steps to eliminate bullying and student a different document that includes the key features noted below and in the participating LEA’s (as defined in this harassment; or notice) commitment. (D) Expanding the school program to model, and they should consult with their State and local attorneys on what • With respect to the relationship offer full-day kindergarten or pre- is most appropriate for their State that between the LEA and the State, the kindergarten. includes, at a minimum, these key State’s counter-signature on the MOU (4) Providing operational flexibility elements. indicates that the LEA’s commitment is and sustained support. The purpose of the model MOU is to consistent with the requirement that a (i) Required activities. The LEA help to specify a relationship that is participating LEA (as defined in this must— specific to Race to the Top and is not notice) implement all or significant (A) Give the school sufficient meant to detail all typical aspects of portions of the State’s plans. operational flexibility (such as staffing, State/LEA grant management or • The strength of the participating calendars/time, and budgeting) to administration. At a minimum, a strong implement fully a comprehensive LEA’s (as defined in this notice) MOU should include the following, commitment will be demonstrated by approach to substantially improve each of which is described in detail student achievement outcomes and the signatures of the LEA below: (i) Terms and conditions; (ii) a superintendent (or an equivalent increase high school graduation rates; scope of work; and, (iii) signatures. and authorized signatory), the president of (i) Terms and conditions: Each the local school board (or equivalent, if (B) Ensure that the school receives participating LEA (as defined in this ongoing, intensive technical assistance applicable) and the local teacher’s union notice) should sign a standard set of leader (if applicable). and related support from the LEA, the terms and conditions that includes, at a Please note the following with regard SEA, or a designated external lead minimum, key roles and responsibilities to the State’s Race to the Top partner organization (such as a school of the State and the LEA; State recourse turnaround organization or an EMO). application: for LEA non-performance; and • (ii) Permissible activities. The LEA assurances that make clear what the In its application, the State need may also implement other strategies for participating LEA (as defined in this only provide an example of the State’s providing operational flexibility and notice) is agreeing to do. standard Participating LEA MOU; it intensive support, such as— (ii) Scope of work: MOUs should does not have to provide copies of every (A) Allowing the school to be run include a scope of work (included in the MOU signed by its participating LEAs under a new governance arrangement, model MOU as Exhibit I) that is (as defined in this notice). If, however, such as a turnaround division within completed by each participating LEA (as States and LEAs have made any changes the LEA or SEA; or defined in this notice). The scope of to the State’s standard MOU, the State (B) Implementing a per-pupil school- work must be signed and dated by an must provide description of the changes based budget formula that is weighted authorized LEA and State official. In the that were made. Please note that the based on student needs. interest of time and with respect for the Department may, at any time, request If a school identified as a persistently effort it will take for LEAs to develop copies of all MOUs between the State lowest-achieving school has detailed work plans, the scope of work and its participating LEAs. implemented, in whole or in part within submitted by LEAs and States as part of • Please see criterion (A)(1)(ii) and the last two years, an intervention that their Race to the Top applications may (A)(1)(iii), and the evidence requested in meets the requirements of the be preliminary. Preliminary scopes of the application, for more information turnaround, restart, or transformation work should include the portions of the and ways in which States will be asked models, the school may continue or State’s proposed reform plans that the to summarize information about the complete the intervention being LEA is agreeing to implement. (Note LEA MOUs. implemented. that in order to participate in a State’s BILLING CODE 4000–01–P
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[FR Doc. E9–27426 Filed 11–17–09; 8:45 am] BILLING CODE 4000–01–C
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Part IV
Department of Education Overview Information; Race to the Top Fund; Notice Inviting Applications for New Awards for Fiscal Year (FY) 2010; Notice
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DEPARTMENT OF EDUCATION (d) Turning around our lowest- science, technology, engineering, and achieving schools. mathematics. Overview Information; Race to the Top Priorities: These priorities are from Invitational Priorities: For FY 2010, Fund; Notice Inviting Applications for the notice of final priorities, these priorities are invitational New Awards for Fiscal Year (FY) 2010 requirements, definitions, and selection priorities. With an invitational priority, criteria for this program, published we signal our interest in receiving Catalog of Federal Domestic Assistance applications that meet the priority; (CFDA) Number: 84.395A. elsewhere in this issue of the Federal Register. however, consistent with 34 CFR DATES: Applications Available: Absolute Priority: For FY 2010, this 75.105(c)(1), we do not give an November 18, 2009. application that meets an invitational Deadline for Notice of Intent to Apply priority is an absolute priority. Under 34 priority preference over other for Phase 1: December 8, 2009. CFR 75.105(c)(3), we consider only Date of Meeting for Potential applications that meet this priority. applications. Priority 3: Invitational Priority— Applicants: The Department intends to Applicants should address this priority Innovations for Improving Early hold two technical assistance planning throughout their applications. Learning Outcomes. workshops. The first will be in Denver, Priority 1: Absolute Priority— Comprehensive Approach to Education The Secretary is particularly Colorado, on December 3, 2009. The interested in applications that include second will be in the Washington, DC Reform. To meet this priority, the State’s practices, strategies, or programs to area on December 10, 2009. We improve educational outcomes for high- recommend that applicants attend one application must comprehensively and coherently address all of the four need students who are young children of these two workshops. (pre-kindergarten through third grade) Deadlines for Transmittal of education reform areas specified in the by enhancing the quality of preschool Applications: ARRA as well as the State Success Phase 1. Applications: January 19, Factors Criteria in order to demonstrate programs. Of particular interest are 2010. that the State and its participating LEAs proposals that support practices that (i) Phase 2 Applications: June 1, 2010. are taking a systemic approach to improve school readiness (including Phase 2 applicants addressing selection education reform. The State must social, emotional, and cognitive); and criterion (B)(1)(ii)(b) may amend their demonstrate in its application sufficient (ii) improve the transition between June 1, 2010 application submission LEA participation and commitment to preschool and kindergarten. through August 2, 2010 by submitting successfully implement and achieve the Priority 4: Invitational Priority— evidence of having adopted common goals in its plans; and it must describe Expansion and Adaptation of Statewide standards after June 1, 2010. No other how the State, in collaboration with its Longitudinal Data Systems. The Secretary is particularly information may be submitted after June participating LEAs, will use Race to the interested in applications in which the 1, 2010 in an amended application. Top and other funds to increase student Deadlines for Intergovernmental achievement, decrease the achievement State plans to expand statewide Review: gaps across student subgroups, and longitudinal data systems to include or Phase 1 Applications: March 18, increase the rates at which students integrate data from special education 2010. graduate from high school prepared for programs, English language learner Phase 2 Applications: August 2, 2010. college and careers. programs,1 early childhood programs, at-risk and dropout prevention Full Text of Announcement Competitive Preference Priority: For FY 2010, this priority is a competitive programs, and school climate and I. Funding Opportunity Description preference priority. Under 34 CFR culture programs, as well as information Purpose of Program: The purpose of 75.105(c)(2)(i), we award 15 additional on student mobility, human resources the Race to the Top Fund, a competitive points to applications that meet this (i.e., information on teachers, grant program authorized under the priority. Applicants should address this principals, and other staff), school American Recovery and Reinvestment priority throughout their applications. finance, student health, postsecondary Act of 2009 (ARRA), is to encourage and Priority 2: Competitive Preference education, and other relevant areas, reward States that are creating the Priority—Emphasis on Science, with the purpose of connecting and conditions for education innovation and Technology, Engineering, and coordinating all parts of the system to reform; achieving significant Mathematics (STEM). allow important questions related to improvement in student outcomes, To meet this priority, the State’s policy, practice, or overall effectiveness including making substantial gains in application must have a high-quality to be asked, answered, and incorporated student achievement, closing plan to address the need to (i) offer a into effective continuous improvement achievement gaps, improving high rigorous course of study in mathematics, practices. The Secretary is also particularly school graduation rates, and ensuring the sciences, technology, and interested in applications in which student preparation for success in engineering; (ii) cooperate with industry States propose working together to college and careers; and implementing experts, museums, universities, research adapt one State’s statewide longitudinal ambitious plans in four core education centers, or other STEM-capable data system so that it may be used, in reform areas: community partners to prepare and (a) Adopting internationally- assist teachers in integrating STEM whole or in part, by one or more other benchmarked standards and content across grades and disciplines, in States, rather than having each State assessments that prepare students for promoting effective and relevant build or continue building such systems success in college and the workplace; instruction, and in offering applied independently. (b) Building data systems that learning opportunities for students; and Priority 5: Invitational Priority—P–20 measure student success and inform (iii) prepare more students for advanced Coordination, Vertical and Horizontal teachers and principals in how they can study and careers in the sciences, Alignment. improve their practices; technology, engineering, and (c) Increasing teacher effectiveness mathematics, including by addressing 1 The term English language learner, as used in this notice, is synonymous with the term limited and achieving equity in teacher the needs of underrepresented groups English proficient, as defined in section 9101 of the distribution; and and of women and girls in the areas of ESEA.
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The Secretary is particularly selection criteria, published elsewhere (3) The timeline for implementing the interested in applications in which the in this issue of the Federal Register. activities; State plans to address how early Application Requirements: (4) The party or parties responsible for childhood programs, K–12 schools, (a) The State’s application must be implementing the activities; postsecondary institutions, workforce signed by the Governor, the State’s chief (5) The information requested in the development organizations, and other school officer, and the president of the performance measures, where State agencies and community partners State board of education (if applicable). applicable (see Appendix A), and where (e.g., child welfare, juvenile justice, and States will respond to this requirement the State proposes plans for reform criminal justice agencies) will in the application, Section III, Race to efforts not covered by a specified coordinate to improve all parts of the the Top Application Assurances. In performance measure, the State is education system and create a more addition, the assurances in Section IV encouraged to propose performance seamless preschool-through-graduate must be signed by the Governor. measures and annual targets for those school (P–20) route for students. (b) The State must describe the efforts; and Vertical alignment across P–20 is progress it has made over the past (6) The information requested as particularly critical at each point where several years in each of the four supporting evidence, if any, for the a transition occurs (e.g., between early education reform areas (as described in criterion, together with any additional childhood and K–12, or between K–12 criterion (A)(3)(i)). information the State believes will be and postsecondary/careers) to ensure (c) The State must include a budget helpful to peer reviewers in judging the that students exiting one level are that details how it will use grant funds credibility of the State’s plan. prepared for success, without and other resources to meet targets and (f) The State must submit a remediation, in the next. Horizontal perform related functions (as described certification from the State Attorney alignment, that is, coordination of in criterion (A)(2)(i)(d)), including how General that— (1) The State’s description of, and services across schools, State agencies, it will use funds awarded under this statements and conclusions concerning and community partners, is also program to— State law, statute, and regulation in its important in ensuring that high-need (1) Achieve its targets for improving application are complete, accurate, and students (as defined in this notice) have student achievement and graduation constitute a reasonable interpretation of access to the broad array of rates and for closing achievement gaps State law, statute, and regulation; and opportunities and services they need (as described in criterion (A)(1)(iii)); the State must also describe its track record (2) At the time the State submits its and that are beyond the capacity of a application, the State does not have any school itself to provide. of improving student progress overall and by student subgroup (as described legal, statutory, or regulatory barriers at Priority 6: Invitational Priority— the State level to linking data on student School-Level Conditions for Reform, in criterion (A)(3)(ii)); and (2) Give priority to high-need LEAs achievement or student growth to Innovation, and Learning. (as defined in this notice), in addition teachers and principals for the purpose The Secretary is particularly to providing 50 percent of the grant to of teacher and principal evaluation. interested in applications in which the participating LEAs (as defined in this (g) When addressing issues relating to State’s participating LEAs (as defined in notice) based on their relative shares of assessments required under the ESEA or this notice) seek to create the conditions funding under Part A of Title I of the subgroups in the selection criteria, the for reform and innovation as well as the Elementary and Secondary Education State must meet the following conditions for learning by providing Act of 1965 (ESEA) for the most recent requirements: schools with flexibility and autonomy year as required under section 14006(c) (1) For student subgroups with in such areas as— of the ARRA. (Note: Because all Race to respect to the National Assessment of (i) Selecting staff; the Top grants will be made in 2010, Educational Progress (NAEP), the State (ii) Implementing new structures and relative shares will be based on total must provide data for the NAEP formats for the school day or year that funding received in FY 2009, including subgroups described in section result in increased learning time (as both the regular Title I, Part A 303(b)(2)(G) of the National Assessment defined in this notice); appropriation and the amount made of Educational Progress Authorization (iii) Controlling the school’s budget; available by the ARRA). Act (20 U.S.C. 9622) (i.e., race, (iv) Awarding credit to students based (d) The State must provide, for each ethnicity, socioeconomic status, gender, on student performance instead of State Reform Conditions Criterion disability, and limited English instructional time; (listed in this notice) that it chooses to proficiency). The State must also (v) Providing comprehensive services address, a description of the State’s include the NAEP exclusion rate for to high-need students (as defined in this current status in meeting that criterion students with disabilities and the notice) (e.g., by mentors and other and, at a minimum, the information exclusion rate for English language caring adults; through local partnerships requested as supporting evidence for the learners, along with clear with community-based organizations, criterion and the performance measures, documentation of the State’s policies nonprofit organizations, and other if any (see Appendix A). and practices for determining whether a providers); (e) The State must provide, for each student with a disability or an English (vi) Creating school climates and Reform Plan Criterion (listed in this language learner should participate in cultures that remove obstacles to, and notice) that it chooses to address, a the NAEP and whether the student actively support, student engagement detailed plan for use of grant funds that needs accommodations; and achievement; and includes, but need not be limited to— (2) For student subgroups with (vii) Implementing strategies to (1) The key goals; respect to high school graduation rates, effectively engage families and (2) The key activities to be undertaken college enrollment and credit communities in supporting the and rationale for the activities, which accumulation rates, and the assessments academic success of their students. should include why the specific required under the ESEA, the State must Final Requirements: The following activities are thought to bring about the provide data for the subgroups requirements are from the notice of final change envisioned and how these described in section 1111(b)(2)(C)(v)(II) priorities, requirements, definitions, and activities are linked to the key goals; of the ESEA (i.e., economically
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disadvantaged students, students from LEAs (as defined in this notice) must mentoring and coaching; (d) major racial and ethnic groups, students include a scope-of-work section. The significantly limit the amount of with disabilities, and students with scope of work submitted by LEAs and coursework required or have options to limited English proficiency); and States as part of their Race to the Top test out of courses; and (e) upon (3) When asked to provide applications will be preliminary. completion, award the same level of information regarding the assessments Preliminary scopes of work should certification that traditional preparation required under the ESEA, States should include the portions of the State’s programs award upon completion. refer to section 1111(b)(3) of the ESEA; proposed reform plans that the LEA is College enrollment refers to the in addition, when describing this agreeing to implement. If a State is enrollment of students who graduate assessment data in the State’s awarded a Race to the Top grant, its from high school consistent with 34 application, the State should note any participating LEAs (as defined in this CFR 200.19(b)(1) and who enroll in an factors (e.g., changes in cut scores) that notice) will have up to 90 days to institution of higher education (as would impact the comparability of data complete final scopes of work, which defined in section 101 of the Higher from one year to the next. must contain detailed work plans that Education Act, Public Law 105–244, 20 Program Requirements: are consistent with their preliminary U.S.C. 1001) within 16 months of Evaluation: The Institute of Education scopes of work and with the State’s graduation. Sciences (IES) will conduct a series of grant application, and should include Common set of K–12 standards means national evaluations of Race to the Top’s the participating LEAs’ specific goals, a set of content standards that define State grantees as part of its evaluation of activities, timelines, budgets, key what students must know and be able to programs funded under the ARRA. The personnel, and annual targets for key do and that are substantially identical Department’s goal for these evaluations performance measures. across all States in a consortium. A State is to ensure that its studies not only Making Work Available: Unless may supplement the common standards assess program impacts, but also otherwise protected by law or agreement with additional standards, provided that provide valuable information to State as proprietary information, the State and the additional standards do not exceed and local educators to help inform and its subgrantees must make any work 15 percent of the State’s total standards improve their practices. (e.g., materials, tools, processes, for that content area. The Department anticipates that the systems) developed under its grant Effective principal means a principal national evaluations will involve such freely available to others, including but whose students, overall and for each components as— not limited to by posting the work on a subgroup, achieve acceptable rates (e.g., • Surveys of States, LEAs, and/or Web site identified or sponsored by the at least one grade level in an academic schools, which will help identify how Department. program funding is spent and the Technical Assistance: The State must year) of student growth (as defined in specific efforts and activities that are participate in applicable technical this notice). States, LEAs, or schools underway within each of the four assistance activities that may be must include multiple measures, education reform areas and across conducted by the Department or its provided that principal effectiveness is selected ARRA-funded programs; designees. evaluated, in significant part, by student • Case studies of promising practices State Summative Assessments: No growth (as defined in this notice). in States, LEAs, and/or schools through funds awarded under this competition Supplemental measures may include, surveys and other mechanisms; and may be used to pay for costs related to for example, high school graduation • Evaluations of outcomes, focusing statewide summative assessments. rates and college enrollment rates, as on student achievement and other Program Definitions: These well as evidence of providing performance measures, to determine the definitions are from the notice of final supportive teaching and learning impact of the reforms implemented priorities, requirements, definitions, and conditions, strong instructional under Race to the Top. selection criteria for this program, leadership, and positive family and Race to the Top grantee States are not published elsewhere in this issue of the community engagement. required to conduct independent Federal Register. Effective teacher means a teacher evaluations, but may propose, within Alternative routes to certification whose students achieve acceptable rates their applications, to use funds from means pathways to certification that are (e.g., at least one grade level in an Race to the Top to support such authorized under the State’s laws or academic year) of student growth (as evaluations. Grantees must make regulations, that allow the establishment defined in this notice). States, LEAs, or available, through formal (e.g., peer- and operation of teacher and schools must include multiple reviewed journals) or informal (e.g., administrator preparation programs in measures, provided that teacher newsletters, Web sites) mechanisms, the the State, and that have the following effectiveness is evaluated, in significant results of any evaluations they conduct characteristics (in addition to standard part, by student growth (as defined in of their funded activities. In addition, as features such as demonstration of this notice). Supplemental measures described elsewhere in this notice and subject-matter mastery, and high-quality may include, for example, multiple regardless of the final components of the instruction in pedagogy and in observation-based assessments of national evaluation, Race to the Top addressing the needs of all students in teacher performance. States, LEAs, and schools are expected the classroom including English Formative assessment means to identify and share promising language learners and student with assessment questions, tools, and practices, make work available within disabilities): (a) Can be provided by processes that are embedded in and across States, and make data various types of qualified providers, instruction and are used by teachers and available in appropriate ways to including both institutions of higher students to provide timely feedback for stakeholders and researchers so as to education and other providers operating purposes of adjusting instruction to help all States focus on continuous independently from institutions of improve learning. improvement in service of student higher education; (b) are selective in Graduation rate means the four-year outcomes. accepting candidates; (c) provide or extended-year adjusted cohort Participating LEAs Scope of Work: supervised, school-based experiences graduation rate as defined by 34 CFR The agreements signed by participating and ongoing support such as effective 200.19(b)(1).
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Highly effective principal means a progress in improving student Innovative, autonomous public principal whose students, overall and achievement (as defined in this notice); schools means open enrollment public for each subgroup, achieve high rates and (b) the management and leadership schools that, in return for increased (e.g., one and one-half grade levels in an necessary to overcome initial start-up accountability for student achievement academic year) of student growth (as problems and establish a thriving, (as defined in this notice), have the defined in this notice). States, LEAs, or financially viable charter school. flexibility and authority to define their schools must include multiple High-poverty school means, consistent instructional models and associated measures, provided that principal with section 1111(h)(1)(C)(viii) of the curriculum; select and replace staff; effectiveness is evaluated, in significant ESEA, a school in the highest quartile of implement new structures and formats part, by student growth (as defined in schools in the State with respect to for the school day or year; and control this notice). Supplemental measures poverty level, using a measure of their budgets. may include, for example, high school poverty determined by the State. Instructional improvement systems graduation rates; college enrollment High-quality assessment means an means technology-based tools and other rates; evidence of providing supportive assessment designed to measure a strategies that provide teachers, teaching and learning conditions, strong student’s knowledge, understanding of, principals, and administrators with instructional leadership, and positive and ability to apply, critical concepts meaningful support and actionable data family and community engagement; or through the use of a variety of item to systemically manage continuous evidence of attracting, developing, and types and formats (e.g., open-ended instructional improvement, including retaining high numbers of effective responses, performance-based tasks). such activities as: instructional teachers. Such assessments should enable planning; gathering information (e.g., Highly effective teacher means a measurement of student achievement through formative assessments (as teacher whose students achieve high (as defined in this notice) and student defined in this notice), interim rates (e.g., one and one-half grade levels growth (as defined in this notice); be of assessments (as defined in this notice), in an academic year) of student growth high technical quality (e.g., be valid, summative assessments, and looking at (as defined in this notice). States, LEAs, reliable, fair, and aligned to standards); student work and other student data); or schools must include multiple incorporate technology where analyzing information with the support measures, provided that teacher appropriate; include the assessment of of rapid-time (as defined in this notice) effectiveness is evaluated, in significant students with disabilities and English reporting; using this information to part, by student growth (as defined in language learners; and to the extent inform decisions on appropriate next this notice). Supplemental measures feasible, use universal design principles instructional steps; and evaluating the may include, for example, multiple (as defined in section 3 of the Assistive effectiveness of the actions taken. Such observation-based assessments of Technology Act of 1998, as amended, 29 systems promote collaborative problem- teacher performance or evidence of U.S.C. 3002) in development and solving and action planning; they may leadership roles (which may include administration. also integrate instructional data with mentoring or leading professional Increased learning time means using student-level data such as attendance, learning communities) that increase the a longer school day, week, or year discipline, grades, credit accumulation, effectiveness of other teachers in the schedule to significantly increase the and student survey results to provide school or LEA. total number of school hours to include early warning indicators of a student’s High-minority school is defined by the additional time for (a) instruction in risk of educational failure. State in a manner consistent with its core academic subjects, including Interim assessment means an Teacher Equity Plan. The State should English; reading or language arts; assessment that is given at regular and provide, in its Race to the Top mathematics; science; foreign languages; specified intervals throughout the application, the definition used. civics and government; economics; arts; school year, is designed to evaluate High-need LEA means an LEA (a) that history; and geography; (b) instruction students’ knowledge and skills relative serves not fewer than 10,000 children in other subjects and enrichment to a specific set of academic standards, from families with incomes below the activities that contribute to a well- and produces results that can be poverty line; or (b) for which not less rounded education, including, for aggregated (e.g., by course, grade level, than 20 percent of the children served example, physical education, service school, or LEA) in order to inform by the LEA are from families with learning, and experiential and work- teachers and administrators at the incomes below the poverty line. based learning opportunities that are student, classroom, school, and LEA High-need students means students at provided by partnering, as appropriate, levels. risk of educational failure or otherwise with other organizations; and (c) Involved LEAs means LEAs that in need of special assistance and teachers to collaborate, plan, and engage choose to work with the State to support, such as students who are living in professional development within and implement those specific portions of the in poverty, who attend high-minority across grades and subjects.2 State’s plan that necessitate full or schools (as defined in this notice), who nearly-full statewide implementation, are far below grade level, who have left 2 Research supports the effectiveness of well- such as transitioning to a common set of school before receiving a regular high designed programs that expand learning time by a minimum of 300 hours per school year. (See K–12 standards (as defined in this school diploma, who are at risk of not Frazier, Julie A.; Morrison, Frederick J. ‘‘The notice). Involved LEAs do not receive a graduating with a diploma on time, who Influence of Extended-year Schooling on Growth of share of the 50 percent of a State’s grant are homeless, who are in foster care, Achievement and Perceived Competence in Early award that it must subgrant to LEAs in who have been incarcerated, who have Elementary School.’’ Child Development. Vol. 69 (2), April 1998, pp.495–497 and research done by accordance with section 14006(c) of the disabilities, or who are English language Mass2020.) Extending learning into before- and learners. after-school hours can be difficult to implement Evaluation of the 21st Century Community Learning High-performing charter school means effectively, but is permissible under this definition Centers Program.’’ http://www.mathematica- a charter school that has been in with encouragement to closely integrate and mpr.com/publications/ coordinate academic work between in-school and redirect_PubsDB.asp?strSite=http:// operation for at least three consecutive out-of school. (See James-Burdumy, Susanne; epa.sagepub.com/cgi/content/abstract/29/4/296 years and has demonstrated overall Dynarski, Mark; Deke, John. ‘‘When Elementary Educational Evaluation and Policy Analysis, Vol. 29 success, including (a) substantial Schools Stay Open Late: Results from The National (4), December 2007, Document No. PP07–121.)
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ARRA, but States may provide other mathematics combined; and (ii) The regarding the extent to which students funding to involved LEAs under the school’s lack of progress on those transition successfully from secondary State’s Race to the Top grant in a assessments over a number of years in school to postsecondary education, manner that is consistent with the the ‘‘all students’’ group. including whether students enroll in State’s application. Rapid-time, in reference to reporting remedial coursework; and (12) other Low-minority school is defined by the and availability of locally-collected information determined necessary to State in a manner consistent with its school- and LEA-level data, means that address alignment and adequate Teacher Equity Plan. The State should data are available quickly enough to preparation for success in provide, in its Race to the Top inform current lessons, instruction, and postsecondary education. application, the definition used. related supports. Program Authority: American Low-poverty school means, consistent Student achievement means— Recovery and Reinvestment Act of 2009, with section 1111(h)(1)(C)(viii) of the (a) For tested grades and subjects: (1) Division A, Section 14006, Public Law ESEA, a school in the lowest quartile of A student’s score on the State’s 111–5. schools in the State with respect to assessments under the ESEA; and, as Applicable Regulations: (a) The poverty level, using a measure of appropriate, (2) other measures of Education Department General poverty determined by the State. student learning, such as those Administrative Regulations (EDGAR) in Participating LEAs means LEAs that described in paragraph (b) of this 34 CFR parts 74, 75, 77, 79, 80, 81, 82, choose to work with the State to definition, provided they are rigorous 84, 85, 86, 97, 98, and 99. (b) The notice implement all or significant portions of and comparable across classrooms. of final priorities, requirements, the State’s Race to the Top plan, as (b) For non-tested grades and subjects: definitions, and selection criteria, specified in each LEA’s agreement with Alternative measures of student learning published elsewhere in this issue of the the State. Each participating LEA that and performance such as student scores Federal Register. receives funding under Title I, Part A on pre-tests and end-of-course tests; will receive a share of the 50 percent of student performance on English II. Award Information a State’s grant award that the State must language proficiency assessments; and Type of Award: Discretionary grant. subgrant to LEAs, based on the LEA’s other measures of student achievement Estimated Available Funds: $4 billion relative share of Title I, Part A that are rigorous and comparable across to be awarded in two Phases. allocations in the most recent year, in classrooms. Estimated Range of Awards: $20 accordance with section 14006(c) of the Student growth means the change in million—$700 million. student achievement (as defined in this ARRA. Any participating LEA that does Note: The Department is not bound by any not receive funding under Title I, Part notice) for an individual student estimates in this notice. The Department will A (as well as one that does) may receive between two or more points in time. A decide on the size of each State’s award funding from the State’s other 50 State may also include other measures based on a detailed review of the budget the percent of the grant award, in that are rigorous and comparable across State requests, considering such factors as the accordance with the State’s plan. classrooms. size of the State, level of LEA participation, Persistently lowest-achieving schools Total revenues available to the State and the proposed activities. means, as determined by the State: (i) means either (a) projected or actual total Project Period: Up to 48 months. Any Title I school in improvement, State revenues for education and other Budget Guidance: States are corrective action, or restructuring that purposes for the relevant year; or (b) encouraged to develop budgets that (a) Is among the lowest-achieving five projected or actual total State match the needs they have outlined in percent of Title I schools in appropriations for education and other their applications. improvement, corrective action, or purposes for the relevant year. To support States in planning their restructuring or the lowest-achieving America COMPETES Act elements budgets, the Department has developed five Title I schools in improvement, means (as specified in section nonbinding budget ranges for each corrective action, or restructuring in the 6401(e)(2)(D) of that Act): (1) A unique State; these are listed below. These State, whichever number of schools is statewide student identifier that does ranges may be used as rough blueprints greater; or (b) Is a high school that has not permit a student to be individually to guide States as they think through had a graduation rate as defined in 34 identified by users of the system; (2) their budgets, but States may prepare CFR 200.19(b) that is less than 60 student-level enrollment, demographic, budgets that are above or below the percent over a number of years; and (ii) and program participation information; ranges specified. The categories were Any secondary school that is eligible (3) student-level information about the developed by ranking every State for, but does not receive, Title I funds points at which students exit, transfer according to its share of the national that (a) Is among the lowest-achieving in, transfer out, drop out, or complete population of children ages 5 through five percent of secondary schools or the P–16 education programs; (4) the 17, and identifying the natural breaks. lowest-achieving five secondary schools capacity to communicate with higher Then, based on population, overlapping in the State that are eligible for, but do education data systems; (5) a State data budget ranges were developed for each not receive, Title I funds, whichever audit system assessing data quality, category. number of schools is greater; or (b) Is a validity, and reliability; (6) yearly test Category 1—$350–700 million: high school that has had a graduation records of individual students with California, Texas, New York, Florida. rate as defined in 34 CFR 200.19(b) that respect to assessments under section Category 2—$200–400 million: is less than 60 percent over a number of 1111(b) of the ESEA (20 U.S.C. 6311(b)); Illinois, Pennsylvania, Ohio, Georgia, years. (7) information on students not tested Michigan, North Carolina, New Jersey. To identify the lowest-achieving by grade and subject; (8) a teacher Category 3—$150–250 million: schools, a State must take into account identifier system with the ability to Virginia, Arizona, Indiana, Washington, both (i) The academic achievement of match teachers to students; (9) student- Tennessee, Massachusetts, Missouri, the ‘‘all students’’ group in a school in level transcript information, including Maryland, Wisconsin. terms of proficiency on the State’s information on courses completed and Category 4—$60–175 million: assessments under section 1111(b)(3) of grades earned; (10) student-level college Minnesota, Colorado, Alabama, the ESEA in reading/language arts and readiness test scores; (11) information Louisiana, South Carolina, Puerto Rico,
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Kentucky, Oklahoma, Oregon, 2. Content and Form of Application details regarding the workshops in late Connecticut, Utah, Mississippi, Iowa, Submission: Requirements concerning November. Updates will be available at Arkansas, Kansas, Nevada. the content of the application, together the Race to the Top Web site http:// Category 5—$20–75 million: New with the forms States must submit, are www.ed.gov/programs/racetothetop. Mexico, Nebraska, Idaho, West Virginia, in the application package for this Attendance at the workshops is strongly New Hampshire, Maine, Hawaii, Rhode competition. encouraged. For those who cannot Island, Montana, Delaware, South Page Limit: The application narrative attend, transcripts of the meetings will Dakota, Alaska, North Dakota, Vermont, (Section VI) is where the applicant be available on our Web site. Wyoming, District of Columbia. addresses the selection criteria that Announcements of any other conference reviewers use to evaluate applications. calls or webinars and Frequently Asked III. Eligibility Information The Department recommends that Questions will also be available on the 1. Eligible Applicants: Eligible applicants limit their narrative Race to the Top Web site. applicants are the 50 States, the District responses in Section VI of the Deadline for Transmittal of of Columbia, and Puerto Rico (referred application to no more than 100 pages Applications: to in this notice as State). of State-authored text, and limit their Phase 1 Applications: January 19, A State must meet the following appendices to no more than 250 pages. 2010. requirements in order to be eligible to The following standards are Phase 2 Applications: June 1, 2010. receive funds under this program. recommended: Phase 2 applicants addressing selection (a) The State’s applications for • A ‘‘page’’ is 8.5″ x 11″, on one side criterion (B)(1)(ii)(b) may amend their funding under Phase 1 and Phase 2 of only, with 1″ margins at the top, bottom, June 1, 2010 application submissions the State Fiscal Stabilization Fund and both sides. through August 2, 2010 by submitting program must be approved by the • Each page is numbered. evidence of having adopted common Department prior to the State being • Line spacing is set to 1.5 spacing, standards after June 1, 2010. No other awarded a Race to the Top grant. and the font used is 12 point Times New information may be submitted in an (b) At the time the State submits its Roman. amended application after June 1, 2010. application, there must not be any legal, 3. Submission Dates and Times: Deadlines for Intergovernmental statutory, or regulatory barriers at the Applications Available: November 18, Review: State level to linking data on student 2009. Phase 1 Applications: March 18, achievement (as defined in this notice) Deadline for Notice of Intent to 2010. or student growth (as defined in this Apply: The Department will be able to Phase 2 Applications: August 2, 2010. notice) to teachers and principals for the develop a more efficient process for Applications for grants under this purpose of teacher and principal reviewing grant applications if we have competition, as well as any amendments evaluation. a better understanding of the number of regarding adoption of common 2. Cost Sharing or Matching: This applications we will receive. Therefore, standards that Phase 2 applicants may program does not require cost sharing or we strongly encourage each potential file after June 1 and through August 2, matching. applicant to send an e-mail notice of its 2010, must be submitted in electronic intent to apply for funding for Phase 1 format on a CD or DVD, with CD–ROM IV. Application and Submission to the e-mail address or DVD–ROM preferred. In addition, Information [email protected] by December 8, States must submit an original and one 1. Address to Request Application 2009. The Secretary may issue a hard copy of Sections III and IV of the Package: deadline for notice of intent to apply for application, which include the Race to You can obtain an application Phase 2 funding at a later time. The the Top Application Assurances and the package via the Internet or from the notice of intent to apply is optional; Accountability, Transparency, Education Publications Center (ED States may still submit applications if Reporting and Other Assurances. E- Pubs). To obtain a copy via the Internet, they have not notified the Department of mailed submissions will not be read. use the following address: http:// their intention to apply. For information (including dates and www.ed.gov/programs/racetothetop/ Date of Meeting for Potential times) about how to submit your index.html. To obtain a copy from ED Applicants: electronic application, please refer to Pubs, write, fax, or call the following: To assist States in preparing the section IV.6, Other Submission Education Publications Center, P.O. Box application and to respond to questions, Requirements in this notice. Evidence, if 1398, Jessup, MD 20794–1398. the Department intends to host two any, of adoption of common standards Telephone, toll free: 1–877–433–7827. Technical Assistance Planning submitted after June 1, 2010, but by FAX: (301) 470–1244. If you use a Workshops for potential applicants August 2, 2010, must be submitted telecommunications device for the deaf prior to the Phase 1 application using the same submission process (TDD), call, toll free: 1–877–576–7734. submission deadline. The first will be in described in section IV, Application and You can also contact ED Pubs at its Denver, Colorado on December 3, 2009. Submission Information of this notice. Web site: http://www.ed.gov/pubs/ The second will be in the Washington, The Department will not consider an edpubs.html or at its e-mail address: DC area on December 10, 2009. We application that does not comply with [email protected]. recommend that applicants attend one the deadline requirements. If you request an application from ED of these two workshops. Individuals with disabilities who Pubs, be sure to identify this program or The purpose of the workshops would need an accommodation or auxiliary aid competition as follows: CFDA 84.395A. be for Department staff to review the in connection with the application Individuals with disabilities can selection criteria, requirements, and process should contact the person listed obtain a copy of the application package priorities with teams of participants under FOR FURTHER INFORMATION in an accessible format (e.g., braille, responsible for drafting State CONTACT in section VII of this notice. If large print, audiotape, or computer applications, as well as for Department the Department provides an diskette) by contacting the person listed staff to answer technical questions about accommodation or auxiliary aid to an under FOR FURTHER INFORMATION the Race to the Top program. The individual with a disability in CONTACT in section VII of this notice. Department plans to release more connection with the application
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process, the individual’s application application (i.e., the CD or DVD, the V. Application Review Information remains subject to all other signed original of Sections III and IV of Selection Criteria: The selection requirements and limitations in this the application, and the copy of that criteria and scoring rubric for this notice. original) by mail (either through the competition are from the notice of final 4. Intergovernmental Review: This U.S. Postal Service or a commercial priorities, requirements, definitions, and program is subject to Executive Order carrier). We must receive the selection criteria, published elsewhere 12372 and the regulations in 34 CFR applications on or before the application in this issue of the Federal Register. The part 79. Information about deadline date. Therefore, to avoid reviewers will utilize the scoring rubric Intergovernmental Review of Federal delays, we strongly recommend sending (which can also be found in Appendix Programs under Executive Order 12372 applications via overnight mail. Mail is in the application package for this B of this notice) in applying the applications to the Department at the following selection criteria: competition. following address: U.S. Department of 5. Funding Restrictions: We reference Education, Application Control Center, A. State Success Factors regulations outlining funding Attention: (CFDA Number 84.395A) LBJ (A)(1) Articulating State’s education restrictions in the Applicable Basement Level 1, 400 Maryland Regulations section of this notice. reform agenda and LEAs’ participation Avenue, SW., Washington, DC 20202– in it: The extent to which— 6. Other Submission Requirements: 4260. Applications for grants under this (i) The State has set forth a competition must be submitted by mail If we receive an application after the comprehensive and coherent reform or hand delivery. The Department application deadline, we will not agenda that clearly articulates its goals strongly recommends the use of consider that application. for implementing reforms in the four overnight mail. Applications c. Submission of Applications by education areas described in the ARRA postmarked on the deadline date but Hand Delivery. States may submit their and improving student outcomes arriving late will not be read. application (i.e., the CD or DVD, the statewide, establishes a clear and a. Application Submission Format signed original of Sections III and IV of credible path to achieving these goals, and Deadline. Applications for grants the application, and the copy of that and is consistent with the specific under this competition, as well as any original) by hand delivery (including via reform plans that the State has proposed amendments regarding adoption of a courier service). We must receive the throughout its application; common standards that Phase 2 applications on or before the application (ii) The participating LEAs (as defined applicants may file after June 1 and deadline date, at the following address: in this notice) are strongly committed to through August 2, 2010, must be U.S. Department of Education, the State’s plans and to effective submitted in electronic format on a CD Application Control Center, Attention: implementation of reform in the four or DVD, with CD–ROM or DVD–ROM (CFDA Number 84.395A) 550 12th education areas, as evidenced by preferred. In addition, they must submit Street, SW., Room 7041, Potomac Center Memoranda of Understanding (MOUs) a signed original of Sections III and IV Plaza, Washington, DC 20202–4260. (as set forth in Appendix D) 3 or other of the application and one copy of that The Application Control Center binding agreements between the State signed original. Sections III and IV of accepts hand deliveries daily between and its participating LEAs (as defined in the application include the Race to the 8:00 a.m. and 4:30:00 p.m., Washington, this notice) that include— Top Application Assurances and the DC time, except Saturdays, Sundays, (a) Terms and conditions that reflect Accountability, Transparency, and Federal holidays. If we receive an strong commitment by the participating Reporting and Other Assurances. application after the application LEAs (as defined in this notice) to the All electronic application files must deadline, we will not consider that State’s plans; be in a .DOC (document), .DOCX application. (b) Scope-of-work descriptions that (document), .RTF (rich text), or .PDF d. Envelope requirements and receipt: require participating LEAs (as defined (Portable Document) format. Each file When an applicant submits its in this notice) to implement all or name should clearly identify the part of application, whether by mail or hand significant portions of the State’s Race the application to which the content is delivery— to the Top plans; and (c) Signatures from as many as responding. If a State submits a file type (1) It must indicate on the envelope other than the four file types specified possible of the LEA superintendent (or that the CFDA number of the equivalent), the president of the local in this paragraph, the Department will competition under which it is not review that material. States should school board (or equivalent, if submitting its application is 84.395A; applicable), and the local teachers’ not password-protect these files. and The CD or DVD should be clearly union leader (if applicable) (one labeled with the State’s name and any (2) The Application Control Center signature of which must be from an other relevant information. will mail to the applicant a notification authorized LEA representative) The Department must receive all grant of receipt of the grant application. If the demonstrating the extent of leadership applications by 4:30:00 p.m., applicant does not receive this support within participating LEAs (as Washington, DC time, on the notification, it should call the U.S. defined in this notice); and application deadline date. We will not Department of Education Application (iii) The LEAs that are participating in accept an application for this Control Center at (202) 245–6288. the State’s Race to the Top plans competition after 4:30:00 p.m., In accordance with EDGAR (including considerations of the Washington, DC time, on the § 75.216(b) and (c), an application will numbers and percentages of application deadline date. Therefore, we not be evaluated for funding if the participating LEAs, schools, K–12 strongly recommend that applicants applicant does not comply with all of students, and students in poverty) will arrange for mailing or hand delivery of the procedural rules that govern the translate into broad statewide impact, their applications in advance of the submission of the application or the allowing the State to reach its ambitious application deadline date. application does not contain the b. Submission of Applications by information required under the 3 See Appendix D for more on participating LEA Mail. States may submit their program. MOUs and for a model MOU.
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yet achievable goals, overall and by grant for which there is evidence of (b) Includes a significant number of student subgroup, for— success; and States; and (a) Increasing student achievement in (ii) Use support from a broad group of (ii)(a) For Phase 1 applications, the (at a minimum) reading/language arts stakeholders to better implement its State’s high-quality plan demonstrating and mathematics, as reported by the plans, as evidenced by the strength of its commitment to and progress toward NAEP and the assessments required statements or actions of support from— adopting a common set of K–12 under the ESEA; (a) The State’s teachers and standards (as defined in this notice) by (b) Decreasing achievement gaps principals, which include the State’s August 2, 2010, or, at a minimum, by a between subgroups in reading/language teachers’ unions or statewide teacher later date in 2010 specified by the State, arts and mathematics, as reported by the associations; and and to implementing the standards NAEP and the assessments required (b) Other critical stakeholders, such as thereafter in a well-planned way; or under the ESEA; the State’s legislative leadership; charter (b) For Phase 2 applications, the (c) Increasing high school graduation school authorizers and State charter State’s adoption of a common set of K– rates (as defined in this notice); and school membership associations (if 12 standards (as defined in this notice) (d) Increasing college enrollment (as applicable); other State and local leaders by August 2, 2010, or, at a minimum, by defined in this notice) and increasing (e.g., business, community, civil rights, a later date in 2010 specified by the the number of students who complete at and education association leaders); State in a high-quality plan toward least a year’s worth of college credit that Tribal schools; parent, student, and which the State has made significant is applicable to a degree within two community organizations (e.g., parent- progress, and its commitment to teacher associations, nonprofit implementing the standards thereafter years of enrollment in an institution of 4 higher education. organizations, local education in a well-planned way. (B)(2) Developing and implementing (A)(2) Building strong statewide foundations, and community-based common, high-quality assessments: The capacity to implement, scale up, and organizations); and institutions of extent to which the State has sustain proposed plans: The extent to higher education. (A)(3) Demonstrating significant demonstrated its commitment to which the State has a high-quality improving the quality of its assessments, overall plan to— progress in raising achievement and closing gaps: The extent to which the evidenced by (as set forth in Appendix (i) Ensure that it has the capacity B) the State’s participation in a required to implement its proposed State has demonstrated its ability to— (i) Make progress over the past several consortium of States that— plans by— (i) Is working toward jointly years in each of the four education (a) Providing strong leadership and developing and implementing common, reform areas, and used its ARRA and dedicated teams to implement the high-quality assessments (as defined in other Federal and State funding to statewide education reform plans the this notice) aligned with the pursue such reforms; State has proposed; consortium’s common set of K–12 (ii) Improve student outcomes overall (b) Supporting participating LEAs (as standards (as defined in this notice); and by student subgroup since at least defined in this notice) in successfully and implementing the education reform 2003, and explain the connections (ii) Includes a significant number of plans the State has proposed, through between the data and the actions that States. such activities as identifying promising have contributed to— practices, evaluating these practices’ (a) Increasing student achievement in Reform Plan Criteria effectiveness, ceasing ineffective reading/language arts and mathematics, (B)(3) Supporting the transition to practices, widely disseminating and both on the NAEP and on the enhanced standards and high-quality replicating the effective practices assessments required under the ESEA; assessments: The extent to which the statewide, holding participating LEAs (b) Decreasing achievement gaps State, in collaboration with its (as defined in this notice) accountable between subgroups in reading/language participating LEAs (as defined in this for progress and performance, and arts and mathematics, both on the NAEP notice), has a high-quality plan for intervening where necessary; and on the assessments required under supporting a statewide transition to and (c) Providing effective and efficient the ESEA; and implementation of internationally operations and processes for (c) Increasing high school graduation benchmarked K–12 standards that build implementing its Race to the Top grant rates. toward college and career readiness by in such areas as grant administration B. Standards and Assessments the time of high school graduation, and and oversight, budget reporting and high-quality assessments (as defined in monitoring, performance measure State Reform Conditions Criteria this notice) tied to these standards. State tracking and reporting, and fund (B)(1) Developing and adopting or LEA activities might, for example, disbursement; common standards: The extent to which include: Developing a rollout plan for (d) Using the funds for this grant, as the State has demonstrated its the standards together with all of their described in the State’s budget and commitment to adopting a common set supporting components; in cooperation accompanying budget narrative, to of high-quality standards, evidenced by with the State’s institutions of higher accomplish the State’s plans and meet (as set forth in Appendix B)— education, aligning high school exit its targets, including, where feasible, by (i) The State’s participation in a criteria and college entrance coordinating, reallocating, or consortium of States that— requirements with the new standards repurposing education funds from other (a) Is working toward jointly and assessments; developing or Federal, State, and local sources so that developing and adopting a common set acquiring, disseminating, and they align with the State’s Race to the of K–12 standards (as defined in this implementing high-quality instructional Top goals; and notice) that are supported by evidence (e) Using the fiscal, political, and that they are internationally 4 Phase 2 applicants addressing selection criterion (B)(1)(ii) may amend their June 1, 2010 application human capital resources of the State to benchmarked and build toward college submission through August 2, 2010 by submitting continue, after the period of funding has and career readiness by the time of high evidence of adopting common standards after June ended, those reforms funded under the school graduation; and 1, 2010.
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materials and assessments (including, (iii) Make the data from instructional (iv) Use these evaluations, at a for example, formative and interim improvement systems (as defined in this minimum, to inform decisions assessments (both as defined in this notice), together with statewide regarding— notice)); developing or acquiring and longitudinal data system data, available (a) Developing teachers and delivering high-quality professional and accessible to researchers so that principals, including by providing development to support the transition to they have detailed information with relevant coaching, induction support, new standards and assessments; and which to evaluate the effectiveness of and/or professional development; engaging in other strategies that instructional materials, strategies, and (b) Compensating, promoting, and translate the standards and information approaches for educating different types retaining teachers and principals, from assessments into classroom of students (e.g., students with including by providing opportunities for practice for all students, including high- disabilities, English language learners, highly effective teachers and principals need students (as defined in this notice). students whose achievement is well (both as defined in this notice) to obtain below or above grade level). additional compensation and be given C. Data Systems To Support Instruction additional responsibilities; D. Great Teachers and Leaders State Reform Conditions Criteria (c) Whether to grant tenure and/or full State Reform Conditions Criteria certification (where applicable) to (C)(1) Fully implementing a statewide teachers and principals using rigorous longitudinal data system: The extent to (D)(1) Providing high-quality standards and streamlined, transparent, which the State has a statewide pathways for aspiring teachers and and fair procedures; and longitudinal data system that includes principals: The extent to which the (d) Removing ineffective tenured and all of the America COMPETES Act State has— untenured teachers and principals after elements (as defined in this notice). (i) Legal, statutory, or regulatory they have had ample opportunities to Reform Plan Criteria provisions that allow alternative routes improve, and ensuring that such to certification (as defined in this decisions are made using rigorous (C)(2) Accessing and using State data: notice) for teachers and principals, standards and streamlined, transparent, The extent to which the State has a particularly routes that allow for and fair procedures. high-quality plan to ensure that data providers in addition to institutions of (D)(3) Ensuring equitable distribution from the State’s statewide longitudinal higher education; of effective teachers and principals: The data system are accessible to, and used (ii) Alternative routes to certification extent to which the State, in to inform and engage, as appropriate, (as defined in this notice) that are in collaboration with its participating key stakeholders (e.g., parents, students, use; and LEAs (as defined in this notice), has a teachers, principals, LEA leaders, (iii) A process for monitoring, high-quality plan and ambitious yet community members, unions, evaluating, and identifying areas of achievable annual targets to— researchers, and policymakers); and that teacher and principal shortage and for (i) Ensure the equitable distribution of the data support decision-makers in the preparing teachers and principals to fill teachers and principals by developing a continuous improvement of efforts in these areas of shortage. plan, informed by reviews of prior such areas as policy, instruction, actions and data, to ensure that students operations, management, resource Reform Plan Criteria in high-poverty and/or high-minority 5 allocation, and overall effectiveness. (D)(2) Improving teacher and schools (both as defined in this notice) (C)(3) Using data to improve principal effectiveness based on have equitable access to highly effective instruction: The extent to which the performance: The extent to which the teachers and principals (both as defined State, in collaboration with its State, in collaboration with its in this notice) and are not served by participating LEAs (as defined in this participating LEAs (as defined in this ineffective teachers and principals at notice), has a high-quality plan to— notice), has a high-quality plan and higher rates than other students; and (i) Increase the acquisition, adoption, ambitious yet achievable annual targets (ii) Increase the number and and use of local instructional to ensure that participating LEAs (as percentage of effective teachers (as improvement systems (as defined in this defined in this notice)— defined in this notice) teaching hard-to- staff subjects and specialty areas notice) that provide teachers, principals, (i) Establish clear approaches to including mathematics, science, and and administrators with the information measuring student growth (as defined in special education; teaching in language and resources they need to inform and this notice) and measure it for each instruction educational programs (as improve their instructional practices, individual student; defined under Title III of the ESEA); and decision-making, and overall (ii) Design and implement rigorous, effectiveness; teaching in other areas as identified by transparent, and fair evaluation systems the State or LEA. (ii) Support participating LEAs (as for teachers and principals that (a) Plans for (i) and (ii) may include, but defined in this notice) and schools that differentiate effectiveness using are not limited to, the implementation are using instructional improvement multiple rating categories that take into of incentives and strategies in such systems (as defined in this notice) in account data on student growth (as areas as recruitment, compensation, providing effective professional defined in this notice) as a significant teaching and learning environments, development to teachers, principals, factor, and (b) are designed and professional development, and human and administrators on how to use these developed with teacher and principal resources practices and processes. systems and the resulting data to involvement; (D)(4) Improving the effectiveness of support continuous instructional (iii) Conduct annual evaluations of teacher and principal preparation improvement; and teachers and principals that include programs: The extent to which the State timely and constructive feedback; as has a high-quality plan and ambitious 5 Successful applicants that receive Race to the part of such evaluations, provide yet achievable annual targets to— Top grant awards will need to comply with the Family Educational Rights and Privacy Act teachers and principals with data on (i) Link student achievement and (FERPA), including 34 CFR Part 99, as well as State student growth for their students, student growth (both as defined in this and local requirements regarding privacy. classes, and schools; and notice) data to the students’ teachers
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and principals, to link this information this notice) if they were eligible to equitable funding, compared to to the in-State programs where those receive Title I funds; and traditional public schools, and a teachers and principals were prepared (ii) Support its LEAs in turning commensurate share of local, State, and for credentialing, and to publicly report around these schools by implementing Federal revenues; the data for each credentialing program one of the four school intervention (iv) The State provides charter schools in the State; and models (as described in Appendix C): with funding for facilities (for leasing (ii) Expand preparation and Turnaround model, restart model, facilities, purchasing facilities, or credentialing options and programs that school closure, or transformation model making tenant improvements), are successful at producing effective (provided that an LEA with more than assistance with facilities acquisition, teachers and principals (both as defined nine persistently lowest-achieving access to public facilities, the ability to in this notice). schools may not use the transformation share in bonds and mill levies, or other (D)(5) Providing effective support to model for more than 50 percent of its supports; and the extent to which the teachers and principals: The extent to schools). State does not impose any facility- which the State, in collaboration with related requirements on charter schools F. General its participating LEAs (as defined in this that are stricter than those applied to notice), has a high-quality plan for its State Reform Conditions Criteria traditional public schools; and (v) The State enables LEAs to operate participating LEAs (as defined in this (F)(1) Making education funding a notice) to— innovative, autonomous public schools priority: The extent to which— (as defined in this notice) other than (i) Provide effective, data-informed (i) The percentage of the total professional development, coaching, charter schools. revenues available to the State (as (F)(3) Demonstrating other significant induction, and common planning and defined in this notice) that were used to collaboration time to teachers and reform conditions: The extent to which support elementary, secondary, and the State, in addition to information principals that are, where appropriate, public higher education for FY 2009 ongoing and job-embedded. Such provided under other State Reform was greater than or equal to the Conditions Criteria, has created, through support might focus on, for example, percentage of the total revenues gathering, analyzing, and using data; law, regulation, or policy, other available to the State (as defined in this conditions favorable to education designing instructional strategies for notice) that were used to support improvement; differentiating reform or innovation that have elementary, secondary, and public increased student achievement or instruction; creating school higher education for FY 2008; and environments supportive of data- graduation rates, narrowed achievement (ii) The State’s policies lead to gaps, or resulted in other important informed decisions; designing equitable funding (a) between high-need outcomes. instruction to meet the specific needs of LEAs (as defined in this notice) and 2. Review and Selection Process: The high-need students (as defined in this other LEAs, and (b) within LEAs, Department will screen applications notice); and aligning systems and between high-poverty schools (as that are received, as described in this removing barriers to effective defined in this notice) and other notice, by the designated deadline, and implementation of practices designed to schools. will determine which States are eligible improve student learning outcomes; and (F)(2) Ensuring successful conditions based on whether they have met (ii) Measure, evaluate, and for high-performing charter schools and eligibility requirement (b); the continuously improve the effectiveness other innovative schools: The extent to Department will not consider further of those supports in order to improve which— those applicants deemed ineligible student achievement (as defined in this (i) The State has a charter school law under eligibility requirement (b). As notice). that does not prohibit or effectively discussed below, States will be screened E. Turning Around the Lowest- inhibit increasing the number of high- for eligibility under eligibility Achieving Schools performing charter schools (as defined requirement (a) at the end of the in this notice) in the State, measured (as selection process, before they would be State Reform Conditions Criteria set forth in Appendix B) by the granted awards. (E)(1) Intervening in the lowest- percentage of total schools in the State The Department intends to use a two- achieving schools and LEAs: The extent that are allowed to be charter schools or tiered review process to judge the to which the State has the legal, otherwise restrict student enrollment in eligible applications. In the initial tier, statutory, or regulatory authority to charter schools; the reviewers would consider only the intervene directly in the State’s (ii) The State has laws, statutes, written applications; in the finalist tier, persistently lowest-achieving schools regulations, or guidelines regarding how reviewers would consider both the (as defined in this notice) and in LEAs charter school authorizers approve, written applications and in-person that are in improvement or corrective monitor, hold accountable, reauthorize, presentations. In both tiers, the action status. and close charter schools; in particular, Department would use independent whether authorizers require that student reviewers who have been chosen from a Reform Plan Criteria achievement (as defined in this notice) pool of qualified educators, scholars, (E)(2) Turning around the lowest- be one significant factor, among others, and other individuals knowledgeable in achieving schools: The extent to which in authorization or renewal; encourage education reform. The Department will the State has a high-quality plan and charter schools that serve student thoroughly screen all reviewers for ambitious yet achievable annual targets populations that are similar to local conflicts of interest to ensure a fair and to— district student populations, especially competitive review process. (i) Identify the persistently lowest- relative to high-need students (as In the initial tier, reviewers will read, achieving schools (as defined in this defined in this notice); and have closed comment on, and score their assigned notice) and, at its discretion, any non- or not renewed ineffective charter applications, using the selection criteria Title I eligible secondary schools that schools; and scoring rubric included in this would be considered persistently (iii) The State’s charter schools notice (see Appendix B). The lowest-achieving schools (as defined in receive (as set forth in Appendix B) Department will select the finalists after
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considering the reviewers’ scores. The If an application is not evaluated or State on reimbursement payment status, finalists will move on to the finalist tier not selected for funding, the Department or delaying or withholding funds. of the competition. Applicants who do will notify the State. A State that receives Race to the Top not move on to the finalist tier will 2. Administrative and National Policy funds must also meet the reporting receive their reviewers’ comments and Requirements: We identify requirements that apply to all ARRA- scores as soon as possible. administrative and national policy funded programs. Specifically, the State The Department intends to ask each requirements in the application package must submit reports, within 10 days finalist to send a team to Washington, and reference these and other after the end of each calendar quarter, DC to present the State’s proposal to a requirements in the Applicable that contain the information required panel of reviewers. The panel will take Regulations section of this notice. under section 1512(c) of the ARRA in this opportunity to ask the State’s team We reference the regulations outlining accordance with any guidance issued by further questions in order to gain a more the terms and conditions of an award in the Office of Management and Budget or comprehensive picture of the State’s the Applicable Regulations section of the Department (ARRA Division A, application proposal, including its plans this notice and include these and other Section 1512(c)). and its capabilities to implement them. specific conditions in the GAN. The In addition, for each year of the (Exact timing will be announced when GAN also incorporates the approved program, the State will submit a report the finalists are selected.) A State’s application as part of the binding to the Secretary, at such time and in presentation team may include up to commitments under the grant. such manner as the Secretary may 3. Reporting: The following five individuals; because the panel of require, that describes: requirements are from the notice of final reviewers is interested primarily in Æ The uses of funds within the State; priorities, requirements, definitions, and Æ hearing from, and asking questions of, How the State distributed the funds selection criteria, published elsewhere State leaders who would be responsible it received; in this issue of the Federal Register. Æ for implementing the State’s Race to the The number of jobs that the A State receiving Race to the Top Governor estimates were saved or Top plan, only those individuals who funds must submit to the Department an would have significant ongoing roles in created with the funds; annual report which must include, in Æ The State’s progress in reducing and responsibilities in executing the addition to the standard elements, a State’s plan should present, and in no inequities in the distribution of highly description of the State’s and its LEAs’ qualified teachers, implementing a State case could presentation teams include progress to date on their goals, consultants. At the conclusion of the longitudinal data system, and timelines, and budgets, as well as actual developing and implementing valid and presentation process, reviewers will performance compared to the annual finalize their scoring of the applications reliable assessments for English targets the State established in its language learners and students with based on the selection criteria and application with respect to each scoring rubric in this notice. disabilities; and performance measure. Further, a State Æ If applicable, a description of each After the review process is complete, receiving funds under this program and modernization, renovation, or repair the Secretary will select, consistent with its participating LEAs are accountable project approved in the State 34 CFR 75.217, the grantees after for meeting the goals, timelines, budget, application and funded, including the considering the rank order of and annual targets established in the amounts awarded and project costs applications, each applicant’s status application; adhering to an annual fund (ARRA Division A, Section 14008). with respect to the Absolute Priority drawdown schedule that is tied to 4. Evidence and Performance and eligibility requirement (a), and any meeting these goals, timelines, budget, Measures: Appendix A to this notice other relevant information. All and annual targets; and fulfilling and contains a listing of the evidence and applicants will receive their reviewers’ maintaining all other conditions for the performance measures. comments and scores. conduct of the project. The Department After awards are made for each phase will monitor a State’s and its VII. Agency Contact of the competition, all of the submitted participating LEAs’ progress in meeting FOR FURTHER INFORMATION CONTACT: applications (both successful and the State’s goals, timelines, budget, and James Butler, U.S. Department of unsuccessful) will be posted on the annual targets and in fulfilling other Education, 400 Maryland Ave., SW., Department’s Web site, together with applicable requirements. In addition, room 3E108, Washington, DC 20202– the final scores each received. The the Department may collect additional 6400. Telephone: 202–205–3775 or by e- Department also intends to post on its data as part of a State’s annual reporting mail: [email protected]. Web site a transcript and/or video of requirements. If a TDD is needed, call the Federal each finalist’s presentation of its To support a collaborative process Relay Service, toll free, at 1–800–877– proposal. between the State and the Department, 8339. States that apply in Phase 1 but are the Department may require that not awarded grants may reapply for applicants who are selected to receive VIII. Other Information funding in Phase 2 (together with those an award enter into a written Accessible Format: Individuals with States that are applying for the first time performance or cooperative agreement disabilities can obtain this document in in Phase 2). Phase 1 winners receive with the Department. If the Department an accessible format (e.g., braille, large full-sized awards, and so do not apply determines that a State is not meeting its print, audiotape, or computer diskette) for additional funding in Phase 2. goals, timelines, budget, or annual on request to the program contact targets or is not fulfilling other person listed under FOR FURTHER VI. Award Administration Information applicable requirements, the INFORMATION CONTACT. 1. Award Notices: If an application is Department will take appropriate action, Electronic Access to This Document: successful, the Department will notify which could include a collaborative You can view this document, as well as the States’ U.S. Representatives and U.S. process between the Department and the all other documents of this Department Senators and send the applicant a Grant State, or enforcement measures with published in the Federal Register, in Award Notification (GAN). We may respect to this grant, such as placing the text or Adobe Portable Document notify the State informally, as well. State in high-risk status, putting the Format (PDF) on the Internet at the
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following site: http://www.ed.gov/news/ Performance Measures showing that it is part of a consortium fedregister. To use PDF you must have • None required. that intends to develop high-quality Adobe Acrobat Reader, which is (A)(3) Demonstrating significant assessments (as defined in this notice) available free at this site. progress in raising achievement and aligned with the consortium’s common Dated: November 10, 2009. closing gaps. set of K–12 standards; or documentation Arne Duncan, that the State’s consortium has applied, Evidence or intends to apply, for a grant through Secretary of Education. Evidence for (A)(3)(ii): NAEP and the separate Race to the Top Assessment Appendix A: Evidence and ESEA results since at least 2003. Include Program (to be described in a Performance Measures in the Appendix all the data requested subsequent notice); or other evidence of the State’s plan to develop and adopt A. State Success Factors in the criterion as a resource for peer reviewers for each year in which a test common, high-quality assessments (as (A)(1) Articulating State’s education was given or data was collected. Note defined in this notice). reform agenda and LEAs’ participation that this data will be used for reference • The number of States participating in it. only and can be in raw format. In the in the assessment consortium and the Evidence narrative, provide the analysis of this list of these States. data and any tables or graphs that best Evidence for (A)(1)(ii): Performance Measures • support the narrative. An example of the State’s standard • None required. Performance Measures Participating LEA MOU, and (B)(3) Supporting the transition to description of variations used, if any. • None required. enhanced standards and high-quality • The completed summary table assessments. indicating which specific portions of the (B) Standards and Assessments State’s plan each LEA is committed to (B)(1) Developing and adopting Evidence implementing, and relevant summary common standards. • Any supporting evidence the State statistics (see Summary Table for Evidence believes will be helpful to peer (A)(1)(ii)(b)). reviewers. • The completed summary table Evidence for (B)(1)(i): indicating which LEA leadership • A copy of the Memorandum of Performance Measures signatures have been obtained (see Agreement, executed by the State, • Optional. Summary Table for (A)(1)(ii)(c)). showing that it is part of a standards Evidence for (A)(1)(iii): (C) Data Systems to Support consortium. Instruction • The completed summary table • A copy of the final standards or, if (C)(1) Fully implementing a statewide indicating the numbers and percentages the standards are not yet final, a copy longitudinal data system. of participating LEAs, schools, K–12 of the draft standards and anticipated students, and students in poverty (see date for completing the standards. Evidence Summary Table for (A)(1)(iii)). • Documentation that the standards • Documentation for each of the • Tables and graphs that show the are or will be internationally America COMPETES Act elements (as State’s goals, overall and by subgroup, benchmarked and that, when well- defined in this notice) that is included requested in the criterion, together with implemented, will help to ensure that in the State’s statewide longitudinal the supporting narrative. In addition, students are prepared for college and data system. describe what the goals would look like careers. were the State not to receive an award • The number of States participating Performance Measures under this program. in the standards consortium and the list • None required. Evidence for (A)(1)(ii) and (A)(1)(iii): of these States. • The completed detailed table, by Evidence for (B)(1)(ii): (C)(2) Accessing and using State data. LEA, that includes the information For Phase 1 applicants: Evidence requested in the criterion (see Detailed • A description of the legal process in • Table for (A)(1)). the State for adopting standards, and the Any supporting evidence the State believes will be helpful to peer Performance Measures State’s plan, current progress, and timeframe for adoption. reviewers. • None required. For Phase 2 applicants: Performance Measures (A)(2) Building strong statewide • Evidence that the State has adopted • capacity to implement, scale up, and the standards. Or, if the State has not yet Optional. sustain proposed plans. adopted the standards, a description of (C)(3) Using data to improve instruction. Evidence the legal process in the State for adopting standards and the State’s plan, Evidence Evidence for (A)(2)(i)(d): current progress, and timeframe for • • The State’s budget, as completed in adoption. Any supporting evidence the State Section XI of the application. The believes will be helpful to peer narrative that accompanies and explains Performance Measures reviewers. the budget and how it connects to the • None required. Performance Measures State’s plan, as completed in Section XI (B)(2) Developing and implementing of the application. common, high-quality assessments. • Optional. Evidence for (A)(2)(ii): (D) Great Teachers and Leaders • A summary in the narrative of the Evidence statements or actions and inclusion of Evidence for (B)(2): (D)(1) Providing high-quality key statements or actions in the • A copy of the Memorandum of pathways for aspiring teachers and Appendix. Agreement, executed by the State, principals.
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Evidence for (D)(1)(i): • Total number of participating LEAs. both (as defined in this notice) who are • • A description of the State’s Total number of principals in highly effective (as defined in this applicable laws, statutes, regulations, or participating LEAs. notice). • Total number of teachers in • other relevant legal documents, Percentage of teachers in schools participating LEAs. including information on the elements that are high-poverty, high-minority, or Data to be requested of grantees in the both (as defined in this notice) who are of the State’s alternative routes (as future: described in the alternative routes to ineffective. • (D)(2)(ii) Number of teachers and • Percentage of teachers in schools certification definition in this notice). principals in participating LEAs with that are low-poverty, low-minority, or Evidence for (D)(1)(ii): qualifying evaluation systems. both (as defined in this notice) who are • (D)(2)(iii) Number of teachers and • A list of the alternative certification ineffective. principals in participating LEAs with • programs operating in the State under Percentage of principals leading qualifying evaluation systems who were the State’s alternative routes to schools that are high-poverty, high- evaluated as effective or better in the certification (as defined in this notice), minority, or both (as defined in this prior academic year. notice) who are highly effective (as and for each: • (D)(2)(iii) Number of teachers and Æ The elements of the program (as defined in this notice). principals in participating LEAs with • described in the alternative routes to Percentage of principals leading qualifying evaluation systems who were certification definition in this notice). schools that are low-poverty, low- Æ The number of teachers and evaluated as ineffective in the prior minority, or both (as defined in this academic year. principals that successfully completed notice) who are highly effective (as • (D)(2)(iv)(b) Number of teachers and each program in the previous academic defined in this notice). principals in participating LEAs with • Percentage of principals leading year. qualifying evaluation systems whose Æ The total number of teachers and schools that are high-poverty, high- evaluations were used to inform principals certified statewide in the minority, or both (as defined in this compensation decisions in the prior previous academic year. notice) who are ineffective. academic year. • Percentage of principals leading Performance Measures • (D)(2)(iv)(b) Number of teachers and schools that are low-poverty, low- • None required. principals in participating LEAs with minority, or both (as defined in this (D)(2) Improving teacher and qualifying evaluation systems who were notice) who are ineffective. principal effectiveness based on evaluated as effective or better and were General data to be provided at time of performance. retained in the prior academic year. application, including baseline data: • (D)(2)(iv)(c) Number of teachers in • Total number of schools that are Evidence participating LEAs with qualifying high-poverty, high-minority, or both (as • Any supporting evidence the State evaluation systems who were eligible defined in this notice). • believes will be helpful to peer for tenure in the prior academic year. Total number of schools that are • reviewers. (D)(2)(iv)(c) Number of teachers in low-poverty, low-minority, or both (as participating LEAs with qualifying defined in this notice). Performance Measures evaluation systems whose evaluations • Total number of teachers in schools General goals to be provided at time were used to inform tenure decisions in that are high-poverty, high-minority, or of application, including baseline data the prior academic year. both (as defined in this notice). • and annual targets: • (D)(2)(iv)(d) Number of teachers and Total number of teachers in schools • (D)(2)(i) Percentage of participating principals in participating LEAs who that are low-poverty, low-minority, or LEAs that measure student growth (as were removed for being ineffective in both (as defined in this notice). • defined in this notice). the prior academic year. Total number of principals leading • (D)(2)(ii) Percentage of participating (D)(3) Ensuring equitable distribution schools that are high-poverty, high- LEAs with qualifying evaluation of effective teachers and principals. minority, or both (as defined in this notice). systems for teachers. Evidence • (D)(2)(ii) Percentage of participating • Total number of principals leading LEAs with qualifying evaluation Evidence for (D)(3)(i): schools that are low-poverty, low- systems for principals. • Definitions of high-minority and minority, or both (as defined in this • (D)(2)(iv) Percentage of low-minority schools as defined by the notice). Data to be requested of grantees in the participating LEAs with qualifying State for the purposes of the State’s future: evaluation systems that are used to Teacher Equity Plan. • inform: Number of teachers and principals Æ (D)(2)(iv)(a) Developing teachers Performance Measures in schools that are high-poverty, high- and principals. minority, or both (as defined in this Æ (D)(2)(iv)(b) Compensating teachers Note: All information below is requested notice) who were evaluated as highly and principals. for Participating LEAs. effective (as defined in this notice) in Æ (D)(2)(iv)(b) Promoting teachers and the prior academic year. Performance Measures for (D)(3)(i): • principals. Number of teachers and principals Æ (D)(2)(iv)(b) Retaining effective General goals to be provided at time in schools that are high-poverty, high- teachers and principals. of application, including baseline data minority, or both (as defined in this Æ (D)(2)(iv)(c) Granting tenure and/or and annual targets: notice) who were evaluated as full certification (where applicable) to • Percentage of teachers in schools ineffective in the prior academic year. teachers and principals. that are high-poverty, high-minority, or • Number of teachers and principals Æ (D)(2)(iv)(d) Removing ineffective both (as defined in this notice) who are in schools that are low-poverty, low- tenured and untenured teachers and highly effective (as defined in this minority, or both (as defined in this principals. notice). notice) who were evaluated as highly General data to be provided at time of • Percentage of teachers in schools effective (as defined in this notice) in application, including baseline data: that are low-poverty, low-minority, or the prior academic year.
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• Number of teachers and principals public can access data on the total number of persistently lowest- in schools that are low-poverty, low- achievement and growth (as defined in achieving schools (as defined in this minority, or both (as defined in this this notice) of the graduates’ students. notice) that States or LEAs attempted to notice) who were evaluated as General data to be provided at time of turn around in the last five years, the ineffective in the prior academic year. application, including baseline data: approach used, and the results and Performance Measures for (D)(3)(ii): • Total number of teacher lessons learned to date. General goals to be provided at time credentialing programs in the State. Performance Measures of application, including baseline data • Total number of principal and annual targets: credentialing programs in the State. • The number of schools for which • Percentage of mathematics teachers • Total number of teachers in the one of the four school intervention who were evaluated as effective or State. models (described in Appendix C) will better. • Total number of principals in the be initiated each year. • Percentage of science teachers who State. (F) General were evaluated as effective or better. Data to be requested of grantees in the • Percentage of special education future: (F)(1) Making education funding a teachers who were evaluated as effective • Number of teacher credentialing priority. or better. programs in the State for which the Evidence • Percentage of teachers in language information (as described in the instruction educational programs who criterion) is publicly reported. Evidence for (F)(1)(i): • were evaluated as effective or better. • Number of teachers prepared by Financial data to show whether and General data to be provided at time of each credentialing program in the State to what extent expenditures, as a application, including baseline data: for which the information (as described percentage of the total revenues • Total number of mathematics in the criterion) is publicly reported. available to the State (as defined in this teachers. • Number of principal credentialing notice), increased, decreased, or • Total number of science teachers. programs in the State for which the remained the same. • Total number of special education Evidence for (F)(1)(ii): information (as described in the • teachers. criterion) is publicly reported. Any supporting evidence the State • Total number of teachers in • Number of principals prepared by believes will be helpful to peer language instruction educational each credentialing program in the State reviewers. programs. for which the information (as described Performance Measures Data to be requested of grantees in the in the criterion) is publicly reported. • future: • Number of teachers in the State None required. • (F)(2) Ensuring successful conditions Number of mathematics teachers in whose data are aggregated to produce for high-performing charter schools and participating LEAs who were evaluated publicly available reports on the State’s other innovative schools. as effective or better in the prior credentialing programs. academic year. • Number of principals in the State • Evidence Number of science teachers in whose data are aggregated to produce participating LEAs who were evaluated Evidence for (F)(2)(i): publicly available reports on the State’s • as effective or better in the prior A description of the State’s credentialing programs. applicable laws, statutes, regulations, or academic year. (D)(5) Providing effective support to • Number of special education other relevant legal documents. teachers and principals. • teachers in participating LEAs who were The number of charter schools evaluated as effective or better in the Evidence allowed under State law and the percentage this represents of the total prior academic year. • Any supporting evidence the State • number of schools in the State. Number of teachers in language believes will be helpful to peer • The number and types of charter instruction educational programs in reviewers. participating LEAs who were evaluated schools currently operating in the State. as effective or better in the prior Performance Measures Evidence for (F)(2)(ii): • academic year. • Optional. A description of the State’s (D)(4) Improving the effectiveness of approach to charter school teacher and principal preparation (E) Turning Around the Lowest- accountability and authorization, and a programs. Achieving Schools description of the State’s applicable (E)(1) Intervening in the lowest- laws, statutes, regulations, or other Evidence achieving schools and LEAs. relevant legal documents. • Any supporting evidence the State • For each of the last five years: believes will be helpful to peer Evidence Æ The number of charter school reviewers. Evidence for (E)(1): applications made in the State. • Æ The number of charter school Performance measures A description of the State’s applicable laws, statutes, regulations, or applications approved. General goals to be provided at time other relevant legal documents. Æ The number of charter school of application, including baseline data applications denied and reasons for the and annual targets: Performance Measures denials (academic, financial, low • Percentage of teacher preparation • None required. enrollment, other). programs in the State for which the (E)(2) Turning around the lowest- Æ The number of charter schools public can access data on the achieving schools. closed (including charter schools that achievement and growth (as defined in were not reauthorized to operate). this notice) of the graduates’ students. Evidence Æ The reasons for the closures or non- • Percentage of principal preparation • The State’s historic performance on renewals (academic, financial, low programs in the State for which the school turnaround, as evidenced by the enrollment, other).
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Evidence for (F)(2)(iii): • A description of the State’s Performance Measures • A description of the State’s applicable statutes, regulations, or other • None required. applicable statutes, regulations, or other relevant legal documents. (F)(3) Demonstrating other significant relevant legal documents. • A description of the statewide reform conditions facilities supports provided to charter • A description of the State’s Evidence approach to charter school funding, the schools, if any. Evidence for (F)(3): amount of funding passed through to Evidence for (F)(2)(v): • A description of the State’s other charter schools per student, and how • A description of how the State applicable key education laws, statutes, those amounts compare with traditional enables LEAs to operate innovative, regulations, or relevant legal documents. public school per-student funding autonomous public schools (as defined allocations. in this notice) other than charter Performance Measures Evidence for (F)(2)(iv): schools. • None required. BILLING CODE 4000–01–P
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BILLING CODE 4000–01–C (vi) Use data to identify and an LEA implements each of the Appendix C. School Intervention implement an instructional program following strategies: Models that is research-based and ‘‘vertically (1) Developing and increasing teacher aligned’’ from one grade to the next as and school leader effectiveness. There are four school intervention well as aligned with State academic (i) Required activities. The LEA models referred to in Selection Criterion standards; must— (E)(2): Turnaround model, restart model, (vii) Promote the continuous use of (A) Replace the principal who led the school closure, or transformation model. student data (such as from formative, school prior to commencement of the Each is described below. interim, and summative assessments) to transformation model; (a) Turnaround model. (1) A inform and differentiate instruction in (B) Use rigorous, transparent, and turnaround model is one in which an order to meet the academic needs of equitable evaluation systems for LEA must— individual students; teachers and principals that— (i) Replace the principal and grant the (viii) Establish schedules and (1) Take into account data on student principal sufficient operational implement strategies that provide growth (as defined in this notice) as a flexibility (including in staffing, increased learning time (as defined in significant factor as well as other factors calendars/time, and budgeting) to this notice); and such as multiple observation-based implement fully a comprehensive (ix) Provide appropriate social- assessments of performance and approach in order to substantially emotional and community-oriented ongoing collections of professional improve student achievement outcomes services and supports for students. practice reflective of student and increase high school graduation (2) A turnaround model may also achievement and increased high-school rates; implement other strategies such as— graduations rates; and (ii) Using locally adopted (i) Any of the required and (2) Are designed and developed with competencies to measure the permissible activities under the teacher and principal involvement; effectiveness of staff who can work transformation model; or (C) Identify and reward school within the turnaround environment to (ii) A new school model (e.g., themed, leaders, teachers, and other staff who, in meet the needs of students, dual language academy). implementing this model, have (A) Screen all existing staff and rehire (b) Restart model. A restart model is increased student achievement and no more than 50 percent; and one in which an LEA converts a school high-school graduation rates and (B) Select new staff; or closes and reopens a school under a identify and remove those who, after (iii) Implement such strategies as charter school operator, a charter ample opportunities have been provided financial incentives, increased management organization (CMO), or an for them to improve their professional opportunities for promotion and career education management organization practice, have not done so; growth, and more flexible work (EMO) that has been selected through a (D) Provide staff with ongoing, high- conditions that are designed to recruit, rigorous review process. (A CMO is a quality, job-embedded professional place, and retain staff with the skills non-profit organization that operates or development (e.g., regarding subject- necessary to meet the needs of the manages charter schools by centralizing specific pedagogy, instruction that students in the turnaround school; or sharing certain functions and reflects a deeper understanding of the (iv) Provide staff with ongoing, high- resources among schools. An EMO is a community served by the school, or quality, job-embedded professional for-profit or non-profit organization that differentiated instruction) that is aligned development that is aligned with the provides ‘‘whole-school operation’’ with the school’s comprehensive school’s comprehensive instructional services to an LEA.) A restart model instructional program and designed program and designed with school staff must enroll, within the grades it serves, with school staff to ensure they are to ensure that they are equipped to any former student who wishes to equipped to facilitate effective teaching facilitate effective teaching and learning attend the school. and learning and have the capacity to and have the capacity to successfully (c) School closure. School closure successfully implement school reform implement school reform strategies; occurs when an LEA closes a school and strategies; and (v) Adopt a new governance structure, enrolls the students who attended that (E) Implement such strategies as which may include, but is not limited school in other schools in the LEA that financial incentives, increased to, requiring the school to report to a are higher achieving. These other opportunities for promotion and career new ‘‘turnaround office’’ in the LEA or schools should be within reasonable growth, and more flexible work SEA, hire a ‘‘turnaround leader’’ who proximity to the closed school and may conditions that are designed to recruit, reports directly to the Superintendent or include, but are not limited to, charter place, and retain staff with the skills Chief Academic Officer, or enter into a schools or new schools for which necessary to meet the needs of the multi-year contract with the LEA or SEA achievement data are not yet available. students in a transformation school. to obtain added flexibility in exchange (d) Transformation model. A (ii) Permissible activities. An LEA for greater accountability; transformation model is one in which may also implement other strategies to
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develop teachers’ and school leaders’ prepare students for college and careers, and related support from the LEA, the effectiveness, such as— including by providing appropriate SEA, or a designated external lead (A) Providing additional supports designed to ensure that low- partner organization (such as a school compensation to attract and retain staff achieving students can take advantage turnaround organization or an EMO). with the skills necessary to meet the of these programs and coursework; (ii) Permissible activities. The LEA needs of the students in a (2) Improving student transition from may also implement other strategies for transformation school; middle to high school through summer providing operational flexibility and (B) Instituting a system for measuring transition programs or freshman intensive support, such as— changes in instructional practices academies; (A) Allowing the school to be run resulting from professional (3) Increasing graduation rates under a new governance arrangement, development; or through, for example, credit-recovery such as a turnaround division within (C) Ensuring that the school is not programs, re-engagement strategies, the LEA or SEA; or required to accept a teacher without the smaller learning communities, (B) Implementing a per-pupil school- mutual consent of the teacher and competency-based instruction and based budget formula that is weighted principal, regardless of the teacher’s performance-based assessments, and based on student needs. seniority. acceleration of basic reading and If a school identified as a persistently (2) Comprehensive instructional mathematics skills; or lowest-achieving school has reform strategies. (4) Establishing early-warning systems implemented, in whole or in part within (i) Required activities. The LEA to identify students who may be at risk the last two years, an intervention that must— of failing to achieve to high standards or meets the requirements of the (A) Use data to identify and graduate. turnaround, restart, or transformation implement an instructional program (3) Increasing learning time and models, the school may continue or that is research-based and ‘‘vertically creating community-oriented schools. complete the intervention being (i) Required activities. The LEA aligned’’ from one grade to the next as implemented. well as aligned with State academic must— standards; and (A) Establish schedules and Appendix D. Participating LEA (B) Promote the continuous use of implement strategies that provide Memorandum of Understanding increased learning time (as defined in student data (such as from formative, Background interim, and summative assessments) to this notice); and inform and differentiate instruction in (B) Provide ongoing mechanisms for Participating LEAs (as defined in this order to meet the academic needs of family and community engagement. notice) in a State’s Race to the Top plan (ii) Permissible activities. An LEA individual students. are required to enter into a (ii) Permissible activities. An LEA may also implement other strategies that Memorandum of Understanding (MOU) may also implement comprehensive extend learning time and create or other binding agreement with the instructional reform strategies, such community-oriented schools, such as— State that specifies the scope of the (A) Partnering with parents and as— work being implemented by the parent organizations, faith- and (A) Conducting periodic reviews to participating LEA (as defined in this community-based organizations, health ensure that the curriculum is being notice). clinics, other State or local agencies, implemented with fidelity, is having the To support States in working and others to create safe school intended impact on student efficiently with LEAs to determine environments that meet students’ social, achievement, and is modified if which LEAs will participate in the emotional, and health needs; State’s Race to the Top application, the ineffective; (B) Extending or restructuring the (B) Implementing a schoolwide U.S. Department of Education has school day so as to add time for such ‘‘response-to-intervention’’ model; produced a model MOU, which is strategies as advisory periods that build (C) Providing additional supports and attached. This model MOU may serve as relationships between students, faculty, professional development to teachers a template for States; however, States and other school staff; are not required to use it. They may use and principals in order to implement (C) Implementing approaches to a different document that includes the effective strategies to support students improve school climate and discipline, key features noted below and in the with disabilities in the least restrictive such as implementing a system of model, and they should consult with environment and to ensure that limited positive behavioral supports or taking their State and local attorneys on what English proficient students acquire steps to eliminate bullying and student is most appropriate for their State that language skills to master academic harassment; or content; (D) Expanding the school program to includes, at a minimum, these key (D) Using and integrating technology- offer full-day kindergarten or pre- elements. based supports and interventions as part kindergarten. The purpose of the model MOU is to of the instructional program; and (4) Providing operational flexibility help to specify a relationship that is (E) In secondary schools— and sustained support. specific to Race to the Top and is not (1) Increasing rigor by offering (i) Required activities. The LEA meant to detail all typical aspects of opportunities for students to enroll in must— State/LEA grant management or advanced coursework (such as (A) Give the school sufficient administration. At a minimum, a strong Advanced Placement or International operational flexibility (such as staffing, MOU should include the following, Baccalaureate; or science, technology, calendars/time, and budgeting) to each of which is described in detail engineering, and mathematics courses, implement fully a comprehensive below: (i) Terms and conditions; (ii) a especially those that incorporate approach to substantially improve scope of work; and, (iii) signatures. rigorous and relevant project-, student achievement outcomes and (i) Terms and conditions: Each inquiry-, or design-based contextual increase high school graduation rates; participating LEA (as defined in this learning opportunities), early-college and notice) should sign a standard set of high schools, dual enrollment programs, (B) Ensure that the school receives terms and conditions that includes, at a or thematic learning academies that ongoing, intensive technical assistance minimum, key roles and responsibilities
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of the State and the LEA; State recourse to complete final scopes of work (which superintendent (or an equivalent for LEA non-performance; and could be attached to the model MOU as authorized signatory), the president of assurances that make clear what the Exhibit II), which must contain detailed the local school board (or equivalent, if participating LEA (as defined in this work plans that are consistent with the applicable) and the local teacher’s union notice) is agreeing to do. preliminary scope of work and with the leader (if applicable). (ii) Scope of work: MOUs should State’s grant application, and should Please note the following with regard include a scope of work (included in the include the participating LEA’s (as to the State’s Race to the Top model MOU as Exhibit I) that is defined in this notice) specific goals, application: completed by each participating LEA (as activities, timelines, budgets, key • In its application, the State need defined in this notice). The scope of personnel, and annual targets for key only provide an example of the State’s work must be signed and dated by an performance measures. authorized LEA and State official. In the (iii) Signatures: The signatures standard Participating LEA MOU; it interest of time and with respect for the demonstrate (a) an acknowledgement of does not have to provide copies of every effort it will take for LEAs to develop the relationship between the LEA and MOU signed by its participating LEAs detailed work plans, the scope of work the State, and (b) the strength of the (as defined in this notice). If, however, submitted by LEAs and States as part of participating LEA’s (as defined in this States and LEAs have made any changes their Race to the Top applications may notice) commitment. to the State’s standard MOU, the State be preliminary. Preliminary scopes of • With respect to the relationship must provide a description of the work should include the portions of the between the LEA and the State, the changes that were made. Please note State’s proposed reform plans that the State’s counter-signature on the MOU that the Department may, at any time, LEA is agreeing to implement. (Note indicates that the LEA’s commitment is request copies of all MOUs between the that in order to participate in a State’s consistent with the requirement that a State and its participating LEAs. Race to the Top application an LEA participating LEA (as defined in this • Please see criteria (A)(1)(ii) and must agree to implement all or notice) implement all or significant (A)(1)(iii), and the evidence requested in significant portions of the State’s reform portions of the State’s plans. the application, for more information plans.) • The strength of the participating and ways in which States will be asked If a State is awarded a Race to the Top LEA’s (as defined in this notice) to summarize information about the grant, the participating LEAs (as defined commitment will be demonstrated by LEA MOUs. in this notice) will have up to 90 days the signatures of the LEA BILLING CODE 4000–01–P
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[FR Doc. E9–27427 Filed 11–17–09; 8:45 am] BILLING CODE 4000–01–C
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Part V
Department of Homeland Security Transportation Security Administration
49 CFR Parts 1520 and 1554 Aircraft Repair Station Security; Proposed Rule
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DEPARTMENT OF HOMELAND Floor, Room W12–140, Washington, DC wish your personally identifiable SECURITY 20590–0001; Fax: 202–493–2251. The information redacted prior to filing in Department of Transportation (DOT), the docket, please so state. TSA will Transportation Security Administration which maintains and processes TSA’s consider all comments that are in the official regulatory dockets, will scan the docket on or before the closing date for 49 CFR Parts 1520 and 1554 submission and post it to FDMS. comments and will consider comments [Docket No. TSA–2004–17131] See SUPPLEMENTARY INFORMATION for filed late to the extent practicable. The format and other information about docket is available for public inspection RIN 1652–AA38 comment submissions. before and after the closing date. Aircraft Repair Station Security FOR FURTHER INFORMATION CONTACT: Handling of Confidential or Proprietary Celio Young, Office of Security Information and Sensitive Security AGENCY: Transportation Security Operations, TSA–29, Transportation Information (SSI) Submitted in Public Administration (TSA), DHS. Security Administration, 601 South Comments ACTION: Notice of proposed rulemaking 12th Street, Arlington, VA 20598–6029; Do not submit comments that include (NPRM). telephone (571) 227–3580; facsimile (571) 227–1905; e-mail trade secrets, confidential commercial SUMMARY: TSA is proposing to issue [email protected]. or financial information, or SSI to the regulations to improve the security of public regulatory docket. Please submit SUPPLEMENTARY INFORMATION: domestic and foreign aircraft repair such comments separately from other stations as required by the Vision 100– Comments Invited comments on the rulemaking. Century of Aviation Reauthorization Comments containing this type of TSA invites interested persons to information should be appropriately Act. The proposed regulations establish participate in this rulemaking by requirements for repair stations that are marked as containing such information submitting written comments, data, or and submitted by mail to the address certificated by the Federal Aviation views. We also invite comments relating listed in FOR FURTHER INFORMATION Administration (FAA) under 14 CFR to the economic, environmental, energy, CONTACT section. part 145 to adopt and implement a recordkeeping, or federalism impacts standard security program and to TSA will not place comments that might result from adopting the containing SSI in the public docket and comply with security directives issued proposals in this document. See by TSA. This rule proposes to codify the will handle them in accordance with ADDRESSES above for information on scope of TSA’s existing inspection applicable safeguards and restrictions where to submit comments. on access. TSA will hold documents program and to require regulated parties With each comment, please identify to allow TSA and Department of containing SSI, confidential business the docket number at the beginning of information, or trade secrets in a Homeland Security (DHS) officials to your comments. TSA encourages enter, inspect, and test property, separate file to which the public does commenters to provide their names and not have access, and place a note in the facilities, and records relevant to repair addresses. The most helpful comments stations. The proposed regulations also public docket explaining that reference a specific portion of the commenters have submitted such provide procedures for TSA to notify rulemaking, explain the reason for any repair stations of any deficiencies in documents. TSA may include a redacted recommended change, and include version of the comment in the public their security programs, and to supporting data. You may submit determine whether a particular repair docket. If an individual requests to comments and material electronically, examine or copy information that is not station presents an immediate risk to in person, or by mail as provided under security. The proposal includes a in the public docket, TSA will treat it ADDRESSES, but please submit your as any other request under the Freedom process whereby a repair station may comments and material by only one seek review of a determination by TSA of Information Act (FOIA) (5 U.S.C. 552) means. If you submit comments by mail and the Department of Homeland that the station has not adequately or delivery, submit them in two copies, addressed security deficiencies or that Security’s (DHS’) FOIA regulation found in an unbound format, no larger than 8.5 in 6 CFR part 5. the repair station poses an immediate by 11 inches, suitable for copying and risk to security. electronic filing. Reviewing Comments in the Docket DATES: Submit comments by January 19, If you want TSA to acknowledge Please be aware that anyone is able to 2010. receipt of your comments submitted by search the electronic form of all ADDRESSES: You may submit comments, mail, include with your comments a comments received into any of our identified by Docket No. TSA–2004– self-addressed, stamped postcard on dockets by the name of the individual 17131, to the Federal Docket which the docket number appears. We submitting the comment (or signing the Management System (FDMS), a will stamp the date on the postcard and comments, if submitted on behalf of an government-wide, electronic docket mail it to you. association, business, labor union, etc.). management system, using any one of TSA will file in the public docket You may review the applicable Privacy the following methods: address, as well as items sent to the Act statement published in the Federal Electronically: You may submit address or email under FOR FURTHER Register on April 11, 2000 (65 FR comments through the Federal INFORMATION CONTACT, in the public 19477) and modified on January 17, eRulemaking portal at http:// docket, except for comments containing 2008 (73 FR 3316). www.regulations.gov. Follow the online confidential information and sensitive You may review TSA’s electronic instructions for submitting comments. security information (SSI).1 Should you public docket on the Internet at http:// Mail, Fax, or In Person: Address, www.regulations.gov. In addition, DOT’s hand-deliver, or fax your written 1 ‘‘Sensitive Security Information’’ or ‘‘SSI’’ is Docket Management Facility provides a comments to the Docket Management information obtained or developed in the conduct of security activities, the disclosure of which would physical facility, staff, equipment, and System, U.S. Department of constitute an unwarranted invasion of privacy, Transportation, 1200 New Jersey reveal trade secrets or privileged or confidential transportation. The protection of SSI is governed by Avenue SE., West Building Ground information, or be detrimental to the security of 49 CFR part 1520.
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assistance to the public. To obtain TSA is proposing to issue regulations characteristics vary widely, TSA assistance or to review comments in to provide for the security of believes that existing security measures, TSA’s public docket, you may visit this maintenance and repair work conducted as well as the corresponding security facility between 9 a.m. to 5 p.m., on aircraft and aircraft components at threat, also vary widely. domestic and foreign repair stations, of Monday through Friday, excluding legal Repair stations are closely regulated holidays, or call (202) 366–9826. This the aircraft and aircraft components and monitored by the FAA and both the docket operations facility is located in located at these repair stations, and of FAA and the air carriers inspect work the West Building Ground Floor, Room the repair station facilities as required W12–140 at 1200 New Jersey Avenue, by Vision 100—Century of Aviation done at repair stations. FAA SE., Washington, DC 20590. Reauthorization Act, codified at 49 performance standards for foreign and U.S.C. 44924 (Vision 100). domestic repair stations are the same. Availability of Rulemaking Document For purposes of this rulemaking, While the FAA has implemented You may obtain an electronic copy ‘‘repair stations’’ are those facilities extensive safety requirements for both using the Internet by certificated by the FAA to perform foreign and domestic repair stations, (1) Searching the Federal Docket maintenance, repair, overhaul, or supplementing those requirements with Management System (FDMS) Web page alterations on U.S. aircraft or aircraft specific security measures for both at http://www.regulations.gov; components, including engines, foreign and domestic repair stations (2) Accessing the Government hydraulics, avionics, safety equipment, would further reduce the likelihood that Printing Office’s Web page at http:// airframes, and interiors. According to terrorists would be able to gain access www.gpoaccess.gov/fr/index.html; or the FAA, there are 4,227 domestic repair to aircraft under repair at a repair (3) Visiting TSA’s Security stations located in the United States and station. As terrorist organizations Regulations Web page at http:// 694 foreign repair stations located continue to seek new and creative www.tsa.gov and accessing the link for outside the United States that have an means of using aircraft to undermine the ‘‘Research Center’’ at the top of the page. FAA certificate under part 145 of the In addition, copies of the rulemaking security and safety of the traveling FAA’s rules.2 public, the importance of requiring all document are available by writing or In addition, for purposes of this calling the individual in the FOR aircraft repair stations to have measures rulemaking, the term ‘‘component’’ in place to prevent persons from FURTHER INFORMATION CONTACT section. includes any article, airframe, aircraft commandeering, tampering, or Make sure to identify the docket number engine, propeller, appliance, or part that sabotaging aircraft has increased as well. of this rulemaking. is under repair. The term is used broadly to encompass both articles and Enhancement of repair station security Outline of the Notice of Proposed will mitigate the potential threat that an Rulemaking appliances as defined by the FAA.3 Aircraft repair stations vary widely in aircraft could be used as a weapon or I. Background size, type of repair work performed, that an aircraft could be destroyed. A. Introduction number of employees, and proximity to B. Statutory Requirements This rulemaking sets forth proposed C. Summary of Proposed Rule an airport. The FAA issues ratings to regulations to require all FAA D. FAA Safety Regulations certificated repair stations for the work certificated repair stations to adopt and E. Public Listening Session and Comments that can be performed at the repair carry out a standard security program. F. Repair Station Site Visits station.4 These include airframe ratings, The proposed regulations list II. Summary of the Proposed Rule power plant ratings, propeller ratings, performance standards for security A. Repair Station Standard Security radio ratings, instrument ratings, and Program measures that would be included in the accessory ratings. Within each rating standard security program. The B. Repair Station Profile there are different classes for particular C. Security Inspections proposed regulations also would require D. Immediate Risk to Security aircraft and equipment. The FAA also repair stations to carry out Security issues limited ratings for certificated III. Section-by-Section Analysis Directives issued by TSA in the event of repair stations that only work on a IV. Rulemaking Analyses and Notices a specific threat. A. Paperwork Reduction Act particular type of airframe or equipment B. International Compatibility or performs only specialized In addition, the proposed regulations C. Regulatory Impact Analyses maintenance operations.5 The FAA codify the scope of TSA’s authority to 1. Regulatory Evaluation Summary certificates repair stations with few conduct inspections of both domestic 2. Executive Order 12866 Assessment employees located in industrial parks and foreign repair stations. The 3. Initial Regulatory Flexibility Analysis (IRFA) and in residences that may work on proposed regulations also provide 4. International Trade Impact Assessment small components, such as aircraft procedures for TSA to notify repair 5. Unfunded Mandates Reform Act radios or seat cushions, as well as repair stations of deficiencies in their security Assessment stations with many employees that program and to determine whether a D. Executive Order 13132, Federalism perform major aircraft overhauls located particular repair station represents an E. Environmental Analysis in close proximity to an airport immediate risk to security. Finally, the F. Energy Impact Analysis runway.6 Because repair station proposal contains a process whereby a I. Background repair station may seek review of a 2 FAA Fact Sheet, ‘‘FAA Oversight of Repair A. Introduction Stations,’’ March 29, 2007. See ‘‘FAA Certificated determination by TSA that security Repair Stations Directory,’’ Advisory Circular (AC) deficiencies have not been addressed or Civil aviation remains a target of 140–7R, for a list of FAA certificated repair stations. that the repair station poses an terrorist activity worldwide. Terrorists 3 See 14 CFR 1.1 and 145.3(b). immediate risk to security. continue to seek opportunities to 4 14 CFR 145.59. destroy public confidence in the safety 5 14 CFR 145.61. B. Statutory Requirements and security of travel, deny the ability 6 Approximately 2,803 domestic repair stations of the public to move and travel freely, have fifteen or fewer employees and 1,407 have five Vision 100 requires DHS to or fewer employees. Approximately 3,000 promulgate security regulations for and damage international economic certificated domestic repair stations are not located security. on an airport. domestic and foreign aircraft repair
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stations.7 The statute includes the and all aircraft and aircraft components who perform maintenance, preventive following additional requirements at the repair station. maintenance, or alterations for repair regarding security audits of foreign • Require each security program to stations, and conduct final inspections repair stations: describe the specific measures the repair of maintained articles. In addition, the • TSA must complete a security station has implemented to identify FAA requires that a certificated repair review and audit of foreign repair individuals authorized access to the station inspect each article upon which stations certificated by the FAA no later repair station, aircraft, and aircraft it has performed maintenance, than six months after regulations are components; control access to the repair preventive maintenance, or alterations issued.8 When conducting the audit, station, aircraft, and aircraft before approving that article for return TSA must give priority to those repair components; challenge individuals who to service.11 The FAA conducts safety stations that pose a significant risk to are not authorized access and use escort inspections of both foreign and security. If security audits are not measures for authorized visitors; domestic repair stations. completed within six months from the provide security awareness training to While these quality control measures date regulations are issued, the FAA is all employees; verify employee provide a significant layer of protection barred from certificating any new background information; designate a and oversight of the components and foreign repair stations until the security security coordinator; and establish a aircraft under repair, the proposed audits are completed for existing repair contingency plan. regulations would supplement those • stations. Require each repair station to measures by requiring that FAA • TSA must notify the FAA of any comply with Security Directives issued certificated repair stations also adopt by TSA. and carry out a security program that security issues or vulnerabilities • identified during the audit and require Establish a process to notify the would include procedures to control foreign repair stations to address any FAA to suspend a certificate upon access to the repair station itself, the such issues or vulnerabilities within 90 written notification by TSA that a repair components and aircraft under repair, days. If, after 90 days, TSA determines station has not corrected security and the work being performed; verify deficiencies identified during a security that the foreign repair station does not the identity of repair station employees; audit within 90 days and to permit maintain and carry out effective security and establish a security coordinator to appeal of a certificate suspension. measures, TSA must notify the FAA and • serve as the point of contact for security- Establish a process to notify the related matters. the FAA must suspend the repair FAA to revoke a certificate upon written station’s certificate until such time as notification by TSA that a repair station E. Public Listening Session and TSA determines that the repair station is an immediate risk to security and to Comments does maintain and carry out effective permit appeal of a certificate revocation. security measures. On February 27, 2004, TSA held a • In developing these proposals, TSA public listening session to receive input TSA must notify the FAA if TSA has consulted with FAA officials determines that a foreign repair station from stakeholders and other interested responsible for repair station safety parties on repair station security issues. poses an immediate risk to security and matters. the FAA must revoke the repair station’s TSA also invited written comments to 12 certificate. TSA must establish an D. FAA Safety Regulations be submitted by March 29, 2004. TSA appeal procedure to be used when a The security regulations proposed in requested specific comments on the certificate is revoked. this NPRM are designed to build upon following issues: • Security measures that are currently the extensive certification and safety C. Summary of Proposed Rule deployed. requirements for repair stations • Existing security vulnerabilities. TSA is proposing regulations to: instituted by the FAA. The FAA • • Codify TSA’s inspection authority. Standards that should be in place to certificates repair stations, as well as prevent unauthorized access, tampering, • Require foreign and domestic repair repairmen who work in repair stations.9 stations certificated by the FAA under and any other security breaches. The FAA requires that in order to • Current security system costs. part 145 of the FAA’s rules to allow receive certification, repair stations • Whether security requirements TSA and DHS officials to enter, inspect, must establish and maintain a quality should be tailored to the type of audit, and test property, facilities, and control system acceptable to the FAA authorization the repair station holds, records relevant to repair stations. that ensures the airworthiness of the • number of employees, proximity to an Require foreign and domestic repair articles on which the repair station or airport, number of repairs completed, or stations certificated by the FAA to adopt any of its contractors performs other characteristics. and carry out a standard security maintenance, preventive maintenance, • Whether aircraft operators should program issued by TSA to safeguard the or alterations.10 The quality control play a role in ensuring that repair security of the repair station, the repair system must describe the procedures the stations maintain a secure workplace. work conducted at the repair station, repair station uses to inspect incoming • Whether any repair station operator raw materials, perform preliminary has experienced a breach in security. 7 This section of Vision 100 is codified at 49 inspection of all articles that are Twelve parties, representing air U.S.C. 44924. The requirement to promulgate maintained at the repair station, qualify carriers, repair station operators and regulations is described in 49 U.S.C. 44924(f). The statute also requires that the Under Secretary for and monitor noncertificated persons employees, manufacturers, and unions, Border and Transportation Security issue the final spoke during the public meeting.13 regulations. The Under Secretary delegated 9 See 14 CFR part 145 and 14 CFR part 65. While While several parties questioned the authority for issuing such regulations to TSA on the FAA only certificates certain repair station need for security regulations, most September 16, 2005. TSA sent a Report to Congress personnel who work in the United States, it does on August 24, 2004, as required at 49 U.S.C. require that those repair station personnel located 44924(g). outside the United States have practical experience 11 14 CFR 145.211. 8 In the Implementing Recommendations of the or training in the work being performed. 12 69 FR 8357 (Feb. 24, 2004). 9/11 Commission Act of 2007 (Pub. L. 110–53, 121 Supervisors in repair stations located outside the 13 A transcript of the public meeting and copies Stat. 266, Aug. 3, 2007), the original 18-month United States must understand, read, and write of all filed comments are available in docket deadline for completing security inspections of English. 14 CFR 145.153. number TSA–2004–17131 at http://regulations.gov/ foreign repair stations was reduced to 6 months. 10 14 CFR 145.211. search.
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recognized the importance of protecting • June 2005—1 repair station in repair station’s facilities as required by the security of the aircraft, the Hamburg, Germany, and 1 repair station 49 U.S.C. 44924. For a more detailed maintenance work that repair stations in Amsterdam, the Netherlands. discussion of the proposed regulations, perform on aircraft and aircraft • August 2005—5 repair stations in see the Section-by-Section Analysis components, and the facility itself, Singapore. portion of this preamble. noting that TSA is required by statute to • November 2006—9 repair stations TSA is also proposing changes to its develop such regulations. Most parties in the state of Arizona. regulations regarding the protection of • also agreed that the regulations should December 2006—3 repair stations in sensitive security information (SSI) to Naples, Italy. specify that a repair station security be tailored to reflect security measures • that may already be in place, as well as January 2007—3 repair stations in program is categorized as SSI and that other factors, such as those listed by the state of Georgia. the repair station operator or owner is • May 2007—1 repair station in TSA in its request for comments. subject to the SSI requirements Singapore and 1 repair station in 14 Concerns were expressed regarding the described in 49 CFR part 1520. Guangzhou, China. expedited timing of the regulations and • July 2007—1 repair station in A. Repair Station Standard Security the security audits, the potential Teterboro, New Jersey. Program financial burdens resulting from the • May 2008—3 repair stations in FAA certificated repair stations, imposition of new regulations, Bogota, Colombia. whether located at airports that have a particularly on small repair stations, These repair station site visits TSA security program,15 at general and the appeal process. Several parties provided valuable insight into the aviation airports, or at off airport recommended that the regulations different types of facilities certificated properties, could be a target of terrorist define what constitutes an ‘‘immediate by the FAA, the different types of repair activity and TSA is proposing that each risk to security,’’ as well as ‘‘existing work conducted at the facilities, and the FAA certificated repair station repair stations.’’ Other parties discussed different types of security measures implement and carry out a standard security initiatives that had been deployed by the various facilities. All of security program issued by TSA to employed at their facilities since the stations visited had some security mitigate that risk. If the repair station is September 11, 2001. measures in place. For example, one already incorporated within an airport’s TSA also received 21 written foreign repair station had over 10,000 security program and uses the airport’s comments, representing the views of employees with many buildings and its access control measures, TSA will repair station operators and employees, own airport. This facility had perimeter consider the repair station to be in unions, air carriers, aircraft owners, and fencing, security guards, and compliance with the security measures manufacturers regarding potential surveillance cameras to control access to proposed in these regulations. security regulations. The majority of the facility. Its employees were required The proposed regulations list the those submitting written comments also to display identification media. Another general security requirements that each supported the need for security foreign repair station had only seven repair station would be required to carry regulations, and agreed that the employees and was located at an out in the standard security program. regulations should be tailored to reflect industrial park. That facility was The standard security program would the particular characteristics of a repair planning to install surveillance cameras require each repair station to include (1) station. Some commenters suggested to be monitored by a private security a description of access controls for the that TSA include general security company. In two countries the facility as well as for the aircraft and/or criteria for domestic and foreign repair government had mandated security aircraft components; (2) a description of stations and others offered requirements for certain repair stations. the measures used to identify employees recommendations regarding specific In the United States, one domestic and others who are authorized to access provisions that should be included in repair station facility with 40 employees aircraft and/or aircraft components; (3) the regulations, such as access controls, relied on personal recognition to a description of the procedures to personnel identification, employee identify individuals authorized entry challenge unauthorized individuals; (4) background checks, and security into the facility, while another domestic a description of security awareness awareness training. The comments repair station with fifteen employees training for employees; (5) the name of provide valuable input as to how repair used identification media and the designated security coordinator; (6) station security issues should be surveillance cameras. By conducting a contingency plan; and (7) a addressed and the proposal reflects these site visits, TSA was able to study description of the means used to verify many of the issues, as well as the security measures already deployed and employee background information. The develop a proposal that reflects repair recommendations, contained in these complete security program contents are station diversity. initial comments. TSA looks forward to discussed in the Section by Section receiving further comments on the II. Summary of the Proposed Rule analysis. These requirements are consistent proposed regulations. TSA proposes to add a new part 1554 with the recommendations included in F. Repair Station Site Visits to its regulations, entitled ‘‘Aircraft the written comments received by TSA, Repair Station Security.’’ The new part In addition to the information would require aircraft repair stations 14 ‘‘Sensitive Security Information’’ or ‘‘SSI’’ is gathered during the public listening that are certificated by the FAA under information obtained or developed in the conduct session and through written comments, 14 CFR part 145, both domestic and of security activities, the disclosure of which would constitute an unwarranted invasion of privacy, TSA visited repair stations to conduct foreign, to adopt and carry out a reveal trade secrets or privileged or confidential research on the physical characteristics standard security program. The information, or be detrimental to the security of of repair stations, the type of repair regulations would require repair transportation. The protection of SSI is governed by work performed, and the extent of stations to safeguard the security of the 49 CFR part 1520. 15 See 49 CFR part 1542 for a description of security measures that had been aircraft and components located at the airport security program requirements. Aircraft implemented. The following site visits station, the maintenance and repair repair stations located at a commercial airport may were conducted: work performed there, as well as the be included within the airport security program.
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as well as with established security aircraft at a repair station location that For instance, TSA may consider procedures for aircraft operators, air is only rated to repair aircraft whether to exempt repair stations that carriers, and airports.16 components if the individual does not only perform maintenance on aircraft Recognizing that a ‘‘one size fits all’’ have access to aircraft. FAA safety that are 12,500 MTOW or less. TSA also approach would not appropriately regulations require inspection of the requests comments on whether there are address the diversity in repair station repair work and the component before other considerations that could be used characteristics, TSA believes that repair it is installed in an aircraft and before to determine potential exemptions. stations should have some flexibility the aircraft is deemed to be airworthy. TSA is aware that the FAA may regarding the particular equipment, Thus, TSA believes it is less likely that certificate repair stations operating on a facilities, and measures that would be a terrorist would attempt to target an Federal government facility, such as a listed in the standard security program aircraft by sabotaging a component at an U.S. military base. TSA believes that the and used to comply with the proposed off airport location. security at such a facility would likely regulations. While TSA would provide This assessment of the greater risk meet and exceed the security a standard security program which posed by repair stations located on or requirements proposed herein. would contain the majority of security adjacent to an airport was also Therefore, TSA would not apply its measures that a repair station must supported by several commenters. One requirements to any FAA certificated adopt to comply with the proposed commenter noted that repair stations repair station at which the Federal regulations, certain measures in the located within an airport posed the government has assumed responsibility standard security program that the greatest risk to security because of the for security measures. repair station must adopt may differ larger number of entry points in such a The issue of requiring drug and depending upon risk factors considered location. Another explained that repair alcohol testing of repair station by TSA. facilities located off airport generally employees was raised during the public TSA would not require repair stations only work on aircraft components and listening session. TSA is not proposing that are not located on or adjacent to an that the multiple layers of testing and to include drug and alcohol testing as airport to implement the same physical oversight already conducted by the FAA part of its security program security measures in the standard serves as an important security function requirements. TSA notes that the FAA security program as those repair stations as well. Another commenter agreed, has instituted alcohol and drug testing that are located on or adjacent to an stating that repair stations that do not as part of its safety regulations.18 TSA airport. In adopting this approach, TSA have access to aircraft do not pose a believes that such testing should remain considered the security risks of repair security risk because the airworthiness under the purview of the FAA. station operations to determine whether of the components are tested before they TSA believes that the standard there were any factors that could are released into service. security program would be useful to increase the security risks of a repair Based on this risk assessment, TSA repair stations that have not developed station. The factors TSA considered would specify particular security or implemented a security program, were (1) size and type of aircraft to measures in the standard security particularly small repair stations that which employees had access; (2) the program that would apply to repair may lack the resources to create their type of repair work permitted by the stations on or adjacent to an airport, but own security program. Further, the FAA certificate; (3) whether the repair that would not be required for other standard security program would station was located on an airport and repair stations. TSA believes that this provide consistency in format and the type of airport; and (4) the number approach would be consistent with its content for the thousands of security of employees at the repair station. efforts to strengthen security measures programs that would be implemented Based on the information acquired at the non public areas of the airport. under this proposal. TSA anticipates during the repair stations site visits, an In addition, TSA would not require requesting comment from repair stations examination of FAA safety repair stations on or adjacent to airports on the standard security program before requirements, and discussions with that only serve aircraft with a maximum a final rule is adopted and will make a FAA safety inspectors, TSA determined certificated take-off weight (MTOW) of draft of the standard security program that while all of the characteristics 12,500 pounds or less to include the available for review and comment by examined had some effect on security same security measures in the standard the repair stations subject to the risks, repair stations that are located on security program as repair stations regulations either electronically, or adjacent to an airport could pose a located on or adjacent to airports that through meetings, or both.19 higher security risk. TSA found that at serve larger aircraft. TSA has long airport locations, there was greater recognized that aircraft with a MTOW B. Repair Station Profile accessibility to aircraft and proximity to over 12,500 pounds pose a greater risk To assess the security risks of a repair a runway, thereby increasing the to security because such aircraft are of station and to establish the priority by possibility that an aircraft could be sufficient size and weight to inflict which repair stations must be inspected, commandeered and used as a weapon or significant damage and loss of lives.17 TSA would require each repair station sabotaged. At off-airport locations, TSA Smaller aircraft may be a less attractive to provide a brief profile, to include found that repair station employees had target for terrorists. Therefore, the general information as to location, such little, if any, access to operational security program would not include the as whether the repair station is located aircraft or runways. Repair station same requirements for repair stations employees at off airport locations that are located on or adjacent to an airport that serves small aircraft. While 18 See 14 CFR part 121 at Appendix I and typically are not the last individuals Appendix J. The FAA requires part 145 certificate with access to aircraft prior to the the proposed regulations apply to all holders and non-certificated repair stations that reintroduction of the aircraft into FAA certificated repair stations, TSA perform safety sensitive functions for air carriers service. TSA believes that it would be requests comment on whether it should and commercial operators under 14 CFR parts 121 exempt certain repair stations after it and 135 to implement an FAA Antidrug Program. difficult for an individual to damage an 19 Security programs will be sensitive security conducts security reviews and audits. information and will not be available to the general 16 See, generally, TSA security regulations at 49 public. See Section-by-Section analysis for § 1520.3 CFR parts 1540, 1542, 1544, and 1546. 17 See 49 CFR 1544.101(d) and 1550.7. in this preamble.
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on or adjacent to an airport,20 the total and the FAA of any deficiencies in a covered persons subject to its SSI number of employees, and the number security program and to permit the requirements. This change would of employees with access to large repair station 90 days to correct such require that repair station operators aircraft. The type of information is deficiencies. If the deficiencies are not adhere to the SSI rules and protect SSI discussed in the Section by Section corrected within 90 days, TSA would from public dissemination. Access to analysis. We note that while the FAA notify the FAA that it must suspend the SSI is strictly limited to those persons holds some of this information, it does repair station’s certificate until such with a need to know, as defined in 49 not have all of it. We invite comments time as TSA determines that the CFR 1520.11. In general, a person has a on the burdens associated with TSA deficiencies are resolved. The proposed need to know specific SSI when he or collecting this profile. As explained regulations also contain a process she requires access to the information in above, TSA has determined that repair whereby a repair station may request order to carry out transportation stations located on or adjacent to an further review of TSA’s determination security activities that are government- airport pose a higher security risk than regarding security deficiencies. approved, -accepted, -funded, -recommended, or -directed, including those that are not located on or adjacent D. Immediate Risk to Security to an airport. In addition, TSA has for purposes of training on, and determined that repair stations on The proposed regulation contains a supervision of, such activities or to airports that perform work on aircraft specific process whereby a repair station provide legal or technical advice over 12,500 MTOW pose a higher that poses an immediate risk to security regarding security-related requirements. security risk. Identifying these higher is identified and the FAA is notified of Accordingly, the protection of SSI risk repair stations will enable TSA to such a determination. The FAA must would apply to each repair station make certain that they are given a higher revoke the certificate of a station that standard security program pursuant to priority when scheduling inspections. TSA determines poses an immediate part 1554. risk to security. Whether the threat is Further, the profile will assist TSA in Part 1554—Aircraft Repair Station immediate would be evaluated on a case determining which measures included Security (New) in the standard security program must by case basis considering existing and be implemented to address the higher potential circumstances as information Section 1554.1—Scope and Purpose risk posture of repair stations that are is received and analyzed. The proposal Section 1554.1 of the proposed located on or adjacent to an airport. provides a repair station with the regulation sets forth the scope and opportunity to obtain the releasable purpose of new part 1554. The proposed C. Security Inspections materials upon which the determination regulations would apply to all repair The proposed regulations would was made and to seek review of such a stations, both domestic and foreign, that codify TSA’s inspection authority and determination. are certificated by the FAA pursuant to would require repair stations to permit III. Section-by-Section Analysis 14 CFR part 145. The purpose of the TSA and DHS officials to enter, inspect, proposed regulations would be to and test property, facilities, and records Part 1520—Protection of Sensitive safeguard the security of domestic and relevant to repair stations. The purpose Security Information foreign aircraft repair stations as of the inspection would be to assess Section 1520.5—Sensitive Security required by 49 U.S.C. 44924. The threats to aviation security, enforce TSA Information requirements would not apply to any security regulations, directives, and FAA certificated repair station at which Protection of Sensitive Security requirements, evaluate all aspects of the the U.S. government has assumed Information (SSI), as codified at 49 CFR repair station security program, verify responsibility for security measures. part 1520, would apply to each repair whether the security program is being station required to adopt and carry out Section 1554.3—Terms Used in This implemented and whether it is effective, a security program. Airport and aircraft Part as well as to identify and correct operator security programs and plans, security deficiencies. Such oversight is Section 1554.3 of the proposed rule amendments, security directives and also necessary to monitor continuing sets forth the definitions of certain terms information circulars, technical compliance with the security used in this part. The term ‘‘repair specifications of security screening and requirements. Since the inspection station’’ is defined as any maintenance detection systems and devices, among program is critical to the enforcement of facility that is certificated by FAA other types of information, all constitute the security program requirement, pursuant to 14 CFR part 145 to perform SSI under current § 1520.5 and are TSA’s inspection authority would maintenance, preventive maintenance, prohibited from public disclosure. TSA extend to all repair stations. TSA would repair, overhaul, or alterations of an is proposing to amend its part 1520 initiate foreign repair station aircraft, airframe, aircraft engine, rules to include a repair station security inspections by giving priority to those propeller, appliance, or component program as SSI. This change would 21 foreign repair stations that pose the part. Since the proposed regulations prevent the public disclosure of the greatest risk to aviation security as apply to both foreign and domestic security measures implemented and required by Vision 100, and that have repair stations, the section defines utilized by a repair station covered identified themselves through the ‘‘domestic repair station’’ as any FAA- under the new rules because such profile as being located on or adjacent certificated repair station located within disclosure would pose a threat to to an airport and as performing repair the fifty States, the District of Columbia, transportation security. It would also work on large aircraft. or the territories and possessions of the ensure that the repair station standard Pursuant to the inspection process United States. A ‘‘foreign repair station’’ security program is protected just as and consistent with Vision 100, TSA is is defined as any FAA-certificated repair other TSA required security programs proposing to notify the repair station station located outside of the fifty are protected. States, the District of Columbia, or the 20 If located on an airport, whether the repair Section 1520.7—Covered Persons station participates in the airport security program 21 The proposed definition is consistent with the will impact the need for the repair station to TSA proposes to amend § 1520.7 to description of the applicability of the FAA’s repair comply with the proposed security regulations. include repair station operators as station regulations at 14 CFR 145.1.
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territories and possessions of the United there, and the facility itself. Repair The standard security program must States. stations would be required to use the include: TSA standard security program unless (1) A description of the measures used Section 1554.5—TSA Inspection otherwise authorized by TSA. to identify individuals who are Authority This section would also require a authorized to enter the repair station to Section 1554.5 would codify TSA’s repair station to submit a profile. The prevent unauthorized individuals from authority to inspect repair stations and purpose of the profile would be to entering the repair station; would require repair stations to permit provide basic information regarding (2) a description of the measures used TSA and DHS officials to enter, inspect, repair station operations to assist TSA to control access to the repair station and test property, facilities, and records in determining what measures the repair and to detect and prevent the entry, relevant to repair stations. This section station must include in its security presence, and movement of would allow TSA to assess threats, program to meet the security unauthorized individuals and vehicles enforce regulations, security directives, requirements. The profile would also into or within the repair station; and requirements, inspect all facilities assist TSA in prioritizing repair stations (3) a description of the measures used and equipment, test the adequacy of for purposes of conducting inspections. to control access to the aircraft and/or security measures, verify the TSA would make the profile template aircraft components to allow only implementation of security measures, available to all repair stations either authorized individuals to have such review security programs and other through the TSA web site, by mail, or access; records, and perform such other duties both. The profile would request the (4) a description of the measures used as appropriate. This section also would following types of information: to challenge any individual entering the allow TSA to request evidence of • Identification of the repair stations, repair station to ascertain the authority compliance, including copies of records such as FAA certificate number, repair of the individual to enter or be present in English. station name as it appears on the FAA in the repair station and measures to The proposed regulatory language is certificate, and repair station address. escort an individual who does not have consistent with the inspection authority • Description of location (on or unescorted authority while within the currently codified at 49 CFR 1542.5 and repair station; 1546.3, which apply to certain U.S. adjacent to an airport, off airport in a business location, off airport private (5) a description of the measures to airports and foreign air carriers. TSA train all individuals with authorized has established protocols and residence). • Security coordinator who will serve access to aircraft and components on the procedures on conducting inspections provisions of this part and the security outside the United States through its as the TSA point of contact. • If on an airport, the name and three program; Foreign Airport and Foreign Air Carrier (6) a description of the measures used letter designator of the airport. Assessment Programs. These established to verify employee background • Total number of employees. procedures require advance notice to information through confirmation of • Number of employees authorized the facility to be inspected and prior employment and any other means unescorted access to aircraft over 12,500 coordination with the U.S. Department as appropriate to validate employee MTOW. of State and the appropriate foreign information; government authorities. TSA inspectors The name and location of each repair (7) the name, 24-hour contact are required to have TSA identification station would assist TSA in identifying information, duties, and training media and credentials with them when the repair station and determining its requirements of the designated security inspecting facilities and must display proximity to an airport since, as coordinator who will serve as the them when requested to do so. TSA will explained above, TSA would consider primary and immediate contact for use these established procedures when such repair stations to be a higher risk security-related activities and conducting inspections of foreign repair than those that are not located on or communications with TSA; stations. adjacent to an airport. The profile (8) a contingency plan; TSA is also amenable to working with information would also help TSA to (9) a diagram with dimensions the U.S. Department of State and foreign prioritize its inspections. Repair stations detailing boundaries and pertinent government authorities to facilitate would also be required to update their physical features of the repair station; inspections of U.S. repair stations that profile information within 30 calendar (10) a list and description of all entry are certificated by a foreign government days if a change in the information points; and authority. TSA currently permits such submitted occurs. This requirement (11) an emergency response contact inspections of U.S. airports and air would enable TSA to maintain current list. carriers by foreign government information on each regulated repair The regulations also would require authorities consistent with ICAO Annex station and make certain that it is that the security program be in writing, 17, Section 2.1. appraised of changes that could impact and signed by the repair station TSA has kept ICAO apprised of the the security posture of a repair station. operator, owner, or other authorized rulemaking and will continue its efforts Repair stations would not be required to person. Each repair station would not to harmonize its regulations with those alert TSA to changes in total number of have to submit the security program to of other countries through its employees or number of employees who TSA, but would have to make it participation in ICAO. work on large aircraft to prevent the available to TSA upon request or during submission of a new profile every time an inspection. Section 1554.101—Adoption and an employee is hired or terminated. The individual standard security Implementation Section 1554.103—Security Program program requirements are discussed Section 1554.101 would require each below. repair station to adopt and carry out a Content, Availability, and Amendment security program designed to safeguard Section 1554.103 would describe the (1) Identification of Authorized aircraft and aircraft components located general requirements describing the Individuals within the repair station, the measures that each repair station must The proposed regulations would maintenance and repair work performed adopt in the standard security program. require the repair station to adopt and
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describe measures to identify broad spectrum, including standard facilities, such as those that use a individuals to prevent unauthorized locks with key control, card swipe personnel identification media system, individuals from entering the repair access locks, cipher locks, locks with employees may have to escort station. The specific requirements for a coded keys, biometric access cards, individuals as part of their personnel identification media system fencing, security guards, surveillance responsibilities. would be included in the standard cameras, and motion detectors. (5) Security Training Measures security program. Personal recognition As part of the standard security may be sufficient at certain repair program, the repair station would be The security program would include station locations. During the inspection required to describe all of the entry measures to conduct initial and process, TSA would use the following points to the facility and the specific recurrent security training programs, factors to evaluate whether the access control measures used for each. such as providing guidance to repair personnel identification media system During the inspection process, TSA station personnel on how to implement must be implemented and what type of would determine whether the access and maintain the security measures features the system must use: control measures deployed at the entry included in the security program. The • Number of employees and number point are appropriate. A repair station security program would also specify of shifts. located on or adjacent to an airport that that the training curriculum be updated • Physical size of the repair station. performs substantial maintenance on to reflect current security requirements. • Number of visitors. large aircraft would be required to have The repair station would be required to • Proximity of other businesses or more stringent access controls. Such maintain records of initial and recurrent operations. controls could include such measures as security training for each employee. The • Type of work, size of aircraft, and card swipe access locks, security guards, standard security program would length of runway. electronically monitored access or include a model curriculum that the • Number of entry points into the motion detectors, fencing or a repair station could modify based on the repair station. combination of such controls. A repair specific security requirements • Airport security features. station located in a private residence or applicable to that repair station. • Other factors that increase ability of in a small component shop in an unauthorized individuals or vehicles to industrial park would be required to (6) Employee Background Verification access the repair station. have less sophisticated controls, such as The security program would include For example, a repair station with 50 standard locks with key control and an the measures by which the repair station employees who work multiple shifts at inventory system to track the number of verifies the employment history of its a repair station, located adjacent to an keys. A repair station would be able to employees and conducts background airport with many access points, might select the above or other measures that checks, to the extent permitted by the be required to adopt and carry out the would provide a appropriate level of laws of the country in which the repair personnel identification media system. security. station is located. The employment Such a repair station would be Access controls would also be history, length of employment, and considered to be a higher risk because required to restrict unauthorized access measures used to verify the individual’s of its proximity to an airport. Further, to components located within the employment would be listed in the the large number of employees working facility, such as locked storage security program. multiple shifts would make it difficult containers and inventory control of (7) Security Coordinator for employees to rely solely on personal keys. recognition as workers from different Each repair station would be required shifts may not be able to recognize each (3) Aircraft Access Control Measures to designate a security coordinator who other. A repair station located in a In addition, the security program would serve as the immediate and residence with a single employee would would include measures to control primary point of contact for security- not be required to adopt the personnel access to aircraft, such as requiring related activities and communications identification media system in the repair stations located on or adjacent to with TSA. Each repair station would security program. TSA would not an airport to secure large aircraft by include the name, responsibilities, and anticipate requiring a repair station locking or disabling the aircraft, keeping contact information of the security located at an airport to adopt a the aircraft in a secure hangar during coordinator in the security program and personnel identification media system if non-operational hours, fencing, would also specify the training employees were required to obtain and surveillance cameras, lighting, and curriculum required for the security display airport identification media. security guards. coordinator. The security coordinator would not necessarily need to be on-site (2) Repair Station Access Control (4) Challenge Procedures at the repair station, but they must be Measures The security program would describe able to coordinate incident management The standard security program would the procedures to be followed when at any time. specify the access control security challenging individuals who cannot be requirements for all repair stations. readily identified. Only those (8) Contingency Plan Such requirements would include individuals who are designated and The security program would include measures to control access to the facility trained in escort procedures would be a contingency plan to include the and to the aircraft and components permitted to escort visitors to the repair specific measures that would be taken to within the repair station, to challenge station. The responsibilities of the escort address security-related incidents. The any individuals to determine if they are would be specified in the security security program would include such authorized to enter or be present in the program. At a small facility with few items as the names of the repair station facility, and to respond if unauthorized employees, the ability to observe employees designated to perform individuals or vehicles are discovered. individuals present within the facility specific tasks, the name and contact Acceptable access control measures may be sufficient to ensure that access information for any contingency would be specified in the security to repair work and/or components is response organizations that would assist program. Such measures would cover a controlled. At large repair station the repair station, a description of the
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DHS threat advisory levels and the Security Directive, the repair station Section 1554.203—Immediate Risk to additional security measures that would would be required to comply with the Security; Revocation of Certificate and be implemented based on the threat measures in the time prescribed or Review Process level, and set forth the responsibilities immediately notify TSA if it is unable Proposed § 1554.203 implements 49 of all personnel involved. The plan to implement the specified security U.S.C. 44924(c)(2) and requires that if would also provide for training and measures so that the repair station can TSA makes an initial determination that regular practices, if appropriate. obtain approval of alternative measures. a repair station poses an immediate risk Other Security Program Requirements The repair station would also be to security, TSA would notify the repair required to restrict the availability of a station and the FAA that the station’s The proposed regulations would also Security Directive to only those require that each security program certificate must be revoked. The repair individuals with an operational need to station may seek review of TSA’s include a diagram of the repair station know. detailing the boundaries and describing determination that the station poses an the physical features of the repair Section 1554.201—Notification of immediate risk to security; however, the station. The security program would Security Deficiencies; Suspension of revocation would remain in effect also include a list and description of all Certificate unless and until the review is complete entry points into the repair station that and a determination is made that the would be supplied by the repair station Proposed § 1554.201 implements the repair station does not pose an operator. These requirements would requirements of 49 U.S.C. 44924(c)(1) immediate risk to security. assist TSA in assessing the security regarding the suspension of a repair Proposed § 1554.203(b) would allow vulnerability of the repair station and station certificate. Vision 100 requires the repair station to request the determining whether security measures audits to be conducted of foreign repair releasable materials upon which the are appropriate. The security program stations within a specified timeframe.22 determination is based. Proposed would also include emergency response TSA would comply with that § 1554.203(c) would permit the repair contact information. requirement and intends to perform station to request a review and to Section 1554.103(b) would require ongoing audits and inspections of all provide a response to TSA. The that the security program be in writing, repair stations covered by the proposed response may include any information and hand-signed by the repair station regulation in order to check for that the repair station deems relevant to operator, owner, or other authorized compliance with the final regulations. a final decision. TSA would conduct an person. The security program would be initial review of the basis for the The proposed regulation would determination and the response and, if required to be accessible to employees provide that TSA would notify the at the repair station facility and be the determination is upheld, a final repair station and the FAA in writing of review by the TSA Assistant Secretary. written in English and in the official any security deficiencies identified by language of the repair station’s country. TSA would notify the FAA of its final TSA during an audit. Repair stations determination. The security program could be would be required to respond within 90 accessible electronically so long as it days of receipt of the written Section 1554.205—Nondisclosure of meets all of the requirements. This notification that the deficiency has been Certain Information section would also include a corrected and include a written requirement that repair stations must This section preserves TSA’s explanation of the efforts, methods, and authority not to disclose classified restrict the distribution, disclosure, and procedures used to correct the availability of sensitive security information or other information deficiency. TSA may re-audit the repair protected by law or regulation. information as described in 49 CFR part station to verify that the deficiencies 1520. have been corrected. The proposal IV. Rulemaking Analyses and Notices Section 1554.103(c) would require a specifies that TSA would provide A. Paperwork Reduction Act repair station to notify TSA of any written notification to the FAA if the amendment to the standard security repair station failed to respond and/or to The Paperwork Reduction Act of 1995 program and would require that the correct the deficiencies within the 90- (PRA) (44 U.S.C. 3501 et seq.) requires repair station acknowledge receipt and day period and that, consistent with the that TSA consider the impact of adopt an emergency amendment issued statute, FAA would suspend the repair paperwork and other information by TSA within the time prescribed in station certificate. The suspension collection burdens imposed on the the emergency amendment. If the repair would remain in effect until TSA makes public and, under the provisions of PRA station cannot implement the a determination that the deficiencies section 3507(d), obtain approval from emergency amendment, the repair had been corrected; TSA would then the Office of Management and Budget station must immediately notify TSA to notify the FAA requesting that the (OMB) for each collection of obtain approval of alternative measures. suspension be lifted.23 This section also information it conducts, sponsors, or They may contact their TSA inspector provides that a repair station may seek requires through regulations. This or the TSA Repair Stations Office at review of a TSA determination that proposed rule contains new information TSA headquarters. deficiencies have not been corrected collection activities subject to the PRA. Accordingly, TSA has submitted the Section 1554.105—Security Directives and includes the redress procedures. following information requirements to This section would require a repair OMB for its review. 22 station to comply with any Security In the Implementing Recommendations of the Title: Aircraft Repair Station Security. 9/11 Commission Act of 2007 (Pub. L 110–53, 121 Directive issued by TSA mandating Stat. 266, Aug. 3, 2007), the 18-month deadline for Summary: This proposal would security measures. Security Directives completing security inspections of foreign repair require all aircraft and aircraft may be issued when TSA determines stations was reduced to 6 months. component repair stations certificated that additional or specific security 23 If the repair station certificate covered more by the FAA under 14 CFR part 145 to than one facility, but not all the facilities were measures are necessary to respond to a found to have security deficiencies, TSA would adopt and maintain a security program threat assessment or a specific threat specify that only the facility that was found to be that meets general security requirements against aviation. Upon receipt of a deficient be suspended. as required by 49 U.S.C. 44924(f). The
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proposed regulations also authorize (2) Evaluate the accuracy of the entities. Third, the Trade Agreements TSA to conduct security audits, agency’s estimate of the burden; Act (19 U.S.C. 2531–2533) prohibits assessments, and inspections of repair (3) Enhance the quality, utility, and agencies from setting standards that stations. Repair stations will be required clarity of the information to be create unnecessary obstacles to the to implement a TSA standard security collected; and foreign commerce of the United States. program which must include the (4) Minimize the burden of the In developing U.S. standards, the Trade specific security measures used by the collection of information on those who Act requires agencies to consider repair station to comply with the are to respond, including using international standards, where regulation. In addition to the actual appropriate automated, electronic, appropriate, as the basis of U.S. security measures, the security program mechanical, or other technological standards. Fourth, the Unfunded must also contain any amendments to collection techniques or other forms of Mandates Reform Act of 1995 (2 U.S.C. the security program, a contingency information technology. 1531–1538) requires agencies to prepare plan, a diagram of the facility with Individuals and organizations may a written assessment of the costs, dimensions detailing boundaries and submit comments on the information benefits, and other effects of proposed physical features, the name and contact collection requirements by January 19, or final rules that include a Federal information for the person responsible 2010. Direct the comments to the mandate likely to result in the for security-related activities and address listed in the ADDRESSES section expenditure by State, local, or tribal communications with TSA, a list and of this document, and fax a copy of governments, in the aggregate, or by the description of all entry points and an them to the Office of Information and private sector, of $100 million or more emergency response contact list. The Regulatory Affairs, Office of annually (adjusted for inflation). security program may be kept Management and Budget, Attention: TSA has prepared a separate detailed electronically or in hard copy format. It DHS–TSA Desk Officer, at (202) 395– analysis document, which is available to does not have to be submitted to TSA, 5806. A comment to OMB is most the public in the docket.24 With respect but must be made available for review effective if OMB receives it within 30 to these four analyses, TSA provides the when TSA conducts a security audit or days of publication. TSA will publish following conclusions, supported by inspection. Other records that must also the OMB control number for this additional summary information. be made available during the audit or information collection in the Federal a. This proposed rule is not an inspection would include employee Register after OMB approves it. economically ‘‘significant regulatory training records, employee background As protection provided by the action’’ as defined in the Executive information, and any security directives Paperwork Reduction Act, as amended, Order. However, this rulemaking may be issued by TSA. an agency may not conduct or sponsor, considered significant because of Use of: This proposal would support and a person is not required to respond Congressional and stakeholder interest the information needs of TSA in order to, a collection of information unless it in security since the events of to ensure the security of maintenance displays a currently valid OMB control September 11, 2001. and repair work conducted on air carrier number. b. The Initial Regulatory Flexibility aircraft and aircraft components at B. International Compatibility Analysis (IRFA) shows that there may repair stations, as well as the security of be a significant impact on a substantial the aircraft and the facility. In keeping with U.S. obligations number of small entities. Respondents (including number of): under the Convention on International c. This proposed rule imposes no The likely respondents to this proposed Civil Aviation, it is TSA policy to significant barriers to international information requirement are the owners comply with ICAO Standards and trade. and/or operators of repair stations Recommended Practices where possible. d. This proposed rule does not impose certificated by the FAA under 14 CFR TSA has determined that these an unfunded mandate on State, local, or part 145, which is estimated to number proposed regulations are consistent with tribal governments, or on the private approximately 5,460 over the next ten ICAO Standards and Recommended sector in excess of $100 million years. Practices for security of airports and (adjusted for inflation) in any one year. facilities contained in Annex 17 of the Frequency: Each of the respondents 2. Executive Order 12866 Assessment initially would submit a repair station Convention, the ICAO Security Manual profile and develop and carry out a and the ICAO Security Audit Reference This summary highlights the costs standard security program provided by Manual. and benefits of the proposed rule to TSA. C. Regulatory Impact Analyses amend the transportation security Annual Burden Estimate: Annualized regulations to further enhance and over the next three years, the average 1. Regulatory Evaluation Summary improve the security of repair stations. yearly burden to create security Changes to Federal regulations must TSA has determined that this is not a programs is estimated to be 12,620 undergo several economic analyses. major rule within the definition of hours for all respondents. Thus, the First, Executive Order 12866, Regulatory Executive Order (EO) 12866, as annual total annual time burden estimate is Planning and Review (58 FR 51735, costs to all parties do not pass the $100 approximately 13,817 hours. The October 4, 1993), directs each Federal million threshold in any year. The estimated annual costs beyond the time agency to propose or adopt a regulation Initial Regulatory Flexibility Analysis burden is approximately $45,200 for all only upon a reasoned determination (IRFA) shows that there may be a respondents when annualized over the that the benefits of the intended significant impact on a substantial next three years. regulation justify its costs. Second, the number of small entities. There are no TSA is soliciting comments to— Regulatory Flexibility Act of 1980 (5 significant economic impacts for the (1) Evaluate whether the proposed U.S.C. 601 et seq., as amended by the required analyses of international trade information requirement is necessary for Small Business Regulatory Enforcement 24 See information on viewing the Docket under the proper performance of the functions Fairness Act (SBREFA) of 1996) requires ‘‘Reviewing Comments in the Docket’’ above. The of the agency, including whether the agencies to analyze the economic Regulatory Evaluation is categorized as ‘‘Supporting information will have practical utility; impact of regulatory changes on small and Related Materials.’’
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or unfunded mandates. Both in this comparison is presented in Table 2 Moreover, as TSA tightens security in summary and the economic evaluation, following the ‘‘Benefits’’ section below. other areas of aviation, repair stations descriptive language is used to try to This comparison is discussed briefly increasingly may become attractive relate the consequences of the above and in greater depth in the body targets for terrorist organizations regulation. The tables are numbered as of the analysis. attempting to evade aviation security they appear in the economic evaluation. Benefits protections currently in place. Although the regulatory evaluation To better inform the comparison of attempts to mirror the terms and A major line of defense against an the costs of the repair station security wording of the regulation, no attempt is aviation-related terrorist act is the program in the proposed rule with the made to precisely replicate the prevention of explosives, weapons, and/ regulatory language and readers are or incendiary devices from getting on benefits to homeland security it might cautioned that the actual regulatory text, board a plane. To date, efforts have been afford due to reduced risk of successful not the text of the evaluation, is binding. primarily related to inspection of terror attack involving an aircraft, a baggage, passengers, and cargo, and breakeven analysis was performed. In Comparison of Costs and Hypothetical security measures at airports that serve this analysis, the annualized costs of the Benefits air carriers. With this rule, attention is program, discounted at seven percent, Comparison of the total undiscounted given to aircraft that are located at repair are compared to the expected benefits of domestic costs of the proposed rule with stations, and to aircraft parts that are at avoiding or preventing three attack potential benefits from the proposed repair stations, themselves to reduce the scenarios of varying consequence. For aircraft repair station security program likelihood of an attack against aviation each scenario, the required extent of relies on a breakeven comparison based and the country. Since repair station annual risk reduction due to the on the extent to which the program personnel have direct access to all parts proposed program, expressed as the must reduce the underlying baseline of an aircraft, the potential exists for a frequency with which attacks must be risk of specific attack impact scenarios terrorist to seek to commandeer or averted, is reported in the final column in order for the program benefits to be compromise an aircraft when the of the break-even analysis (Table 2) greater than the expected costs. Such a aircraft is at one of these facilities. below. TABLE 2—FREQUENCY OF ATTACKS AVERTED FOR AIRCRAFT REPAIR STATION SECURITY COSTS TO EQUAL EXPECTED BENEFITS, BY ATTACK SCENARIO [Annualized at 7 percent]
Valuation of Value of a moderate Valuation of Estimated Attacks averted by Lives statistical Moderate injuries Severe serious injuries aircraft market Total impact repair station security Attack scenario lost life (VSL) injuries at 1.55% injuries at 18.75% value ($ million) required to break at $5.8M of VSL of VSL ($ million) even ($ million) ($ million) ($ million)
A B = A × 5.8 C D = C × .0899 E F = E × 1.0875 G H = B+D+F+G = H ÷ $24.5M *
1 Minimal ...... 3 $17.4 10 $0.9 $0.0 $9.3 $27.6 one every 1.1 years. 2 Aircraft Target .. 132 765.6 0.0 0.0 21.8 787.4 one every 32.1 years. 3 Moderate ...... 250 1,450.0 0.0 750 815.6 9.3 2,274.9 one every 92.7 years. * The total cost of the rule annualized at 7 percent.
Costs analyzed. Table 31 that follows provides undiscounted and at three and seven As required, alternatives to the the 10-year cost of the preferred percent discount rates. primary rule requirements were alternative and two other alternatives,
TABLE 31—TOTAL 10-YEAR COSTS BY SCENARIO AND DISCOUNT RATE [2006$ millions]
Total by scenario Undiscounted 3% Discount 7% Discount
Primary Scenario ...... $344.4 $293.3 $241.0 Security Threat Assessments ...... 347.0 295.7 243.1 Vulnerability Assessments ...... 347.1 295.8 243.3
Using a seven percent discount rate, 3. Initial Regulatory Flexibility Analysis regulation.’’ To achieve that principle, TSA estimated the 10-year cost impacts (IRFA) the RFA requires agencies to solicit and for the primary scenario of this consider flexible regulatory proposals proposed rule would total $241.0 The Regulatory Flexibility Act of 1980 and to explain the rationale for their million. This total is distributed among (RFA) establishes ‘‘as a principle of actions. The RFA covers a wide range of regulatory issuance that agencies shall domestic repair stations, which would small entities, including small endeavor, consistent with the objective incur total costs of $118.6 million; businesses, not-for-profit organizations, of the rule and of applicable statutes, to foreign repair stations, which would and small governmental jurisdictions. fit regulatory and informational incur costs of $68.7 million; and TSA- requirements to the scale of the Agencies must perform a review to projected Federal Government costs, business, organizations, and determine whether a proposed or final which would be $53.7 million. governmental jurisdictions subject to rule will have a significant economic
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impact on a substantial number of small the industry, the U.S. Census Bureau station, the maintenance and repair entities. If the determination is that it describes firms in this market as work conducted there, as well as the will, the agency must prepare a ‘‘providing specialized services for air repair station’s facilities, as required by regulatory flexibility analysis as transportation (except air traffic control 49 U.S.C. 44924. described in the RFA. However, if an and other airport operations).’’ 25 The TSA is also proposing changes to its agency determines that a proposed or Small Business Administration defines regulations regarding the protection of final rule is not expected to have a a small business within this NAICS sensitive security information (SSI) to significant economic impact on a code as one having annual revenues of specify that a repair station security substantial number of small entities, $7.0 million or less.26 More details program is categorized as SSI and that section 605(b) of the 1980 RFA, as about the industry can be obtained by the repair station operator or owner is amended, provides that the head of the reading the ‘‘Discussion of the Industry subject to the SSI requirements. agency may so certify and a regulatory and Status Quo’’ section of the The proposed rule would require flexibility analysis is not required. The Regulatory Evaluation. repair stations to establish security certification must include a statement To estimate the number of small programs. TSA would provide a providing the factual basis for this businesses in the aircraft repair station standard security program that would determination, and the reasoning should industry affected by this NPRM, TSA include the following: Access controls, be clear. accessed information maintained by a personnel identification system, As part of implementing this NPRM, Dun & Bradstreet, a provider of security awareness training, the TSA expects security to be integrated international and U.S. business data. designation of a security coordinator, into actions the same way safety has and The data obtained for this effort did not employee background verification, and to become an integral component of identify the type of maintenance the a contingency plan. While repair doing business rather than adding layers repair stations are certificated to stations would have some flexibility or extra program costs. The primary cost perform or their location. This made it regarding the particular equipment, to repair stations resulting from this difficult for TSA to determine facilities, and measures used to comply NPRM would be additional hours for compliance costs for the identified with the general security requirements, personnel to perform the duties of the small businesses (this is discussed more their security methods would need to repair station security coordinator. For below). address each of these requirements in a many stations this may constitute an Through its research, TSA obtained manner commensurate with the insignificant impact, while for others Dun & Bradstreet revenue and station’s security risk. For example, the costs to comply with the proposed employment records for 2,276 domestic small repair stations may meet the rule may prove significant. TSA has aircraft repair stations. Of this total, requirement for a personal identification conducted an initial regulatory 2,123 reflected small businesses, as system through employee recognition flexibility analysis and believes the defined by SBA, and 153 did not. TSA and challenge procedures, while TSA proposed requirements may result in a was unable to find data on the would require stations located on or significant economic impact on a remaining domestic repair stations. For adjacent to an airport and having 50 or substantial number of small entities. the purposes of this analysis, and to more employees to implement a formal TSA requests comments, particularly remain conservative in its estimates, badging system. those supported by data, on this TSA assumed that the remaining The proposed rule would require each preliminary conclusion. domestic repair stations are also small. repair station to complete and return to Reason for the Proposed Rule TSA thus estimated that 4,115 of 4,268 TSA a brief profile form. The profile domestic aircraft repair stations are would identify information, such as In 2003, Congress enacted Vision small businesses, as defined by SBA. whether the repair station is located at 100—Century of Aviation an airport,27 the total number of Description and Estimate of Compliance Reauthorization Act (Vision 100), Public employees, and the number of Requirements Law 108–176, (117 Stat. 2490, December employees with unescorted access to 12, 2003). Vision 100, which was signed In order to address the need for aircraft with a maximum certificated into law by President George W. Bush security measures at aircraft repair takeoff weight (MTOW) exceeding on December 12, 2003, expands TSA’s stations and to fulfill the obligations set 12,500 pounds. These indicators would authority to address the security of the forth by Congress, TSA is proposing to assist TSA in conducting a risk-based civil aviation system by requiring TSA add a new part 1554 to its regulations, analysis of the repair station in order to to issue final regulations to ensure the entitled ‘‘Aircraft Repair Station determine what measures would be security of both domestic and foreign Security.’’ The new part would require needed to meet the security aircraft repair stations. all aircraft repair stations that are requirements proposed in the Objectives of the Proposed Rule certificated by the FAA under 14 CFR regulations. part 145, both domestic and foreign, to The proposed regulations also would The requirements proposed in this adopt and carry out a security program establish TSA’s authority to conduct NPRM are designed to increase overall that includes specific security security audits, assessments, and civil aviation security by bolstering the requirements. The regulations would inspections in order to ascertain the level of security at domestic and foreign require repair stations to safeguard adequacy of the measures employed by aircraft repair stations. aircraft and components located at the the repair stations to implement and Descriptions and Estimates of the maintain the security requirements. The Number of Small Entities 25 U.S. Census Bureau, ‘‘2002 NAICS proposed inspections and appeals Definitions.’’ Retrieved from http:// processes are described in detail in the Aircraft repair stations are classified www.census.gov/epcd/naics02/def/ by the U.S. Census Bureau as falling ND488190.HTM#N488190 on January 31, 2007. NPRM. primarily within the North American 26 U.S. Small Business Administration, ‘‘Table of Small Business Size Standards Matched to North 27 If located on an airport, whether the repair Industry Classification System (NAICS), American Industry Classification System Codes.’’ station participates in the airport security program code 488190 Other Support Activities http://www.sba.gov/idc/groups/public/documents/ will impact the repair station’s compliance with the for Air Transportation. In its account of sba_homepage/serv_sstd_tablepdf.pdf. proposed security regulations.
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In its effort to fulfill the requirements or adjacent to an airport would require These totals exclude costs for repair of the RFA, TSA attempted to estimate 8 hours on average to complete their stations located on or adjacent to an all costs of complying with the above security programs whereas repair airport and having 50 or more described requirements for each firm for stations located off-airport would employees to implement a badging which it had Dun & Bradstreet data and require only 4. Unfortunately, TSA was system. TSA assumed that firms with to calculate those costs as a percent of unable to pair the data from Dun & 100 or more employees likely already the repair station’s reported revenues. Bradstreet with repair station data have a badging system. Based on the TSA determined that this methodology provided by the FAA. As a result, TSA Dun and Bradstreet data, TSA estimated would best conclude whether the could not estimate compliance costs the average compliance cost for firms particular to repair station proposed rule would represent a reported as having between 50 and 99 characteristics such as whether it is considerable economic burden to a large employees would be approximately number of small businesses. After located on an airport or performs substantial maintenance on commercial $4,728 before adding costs to implement completing this preliminary analysis a badging system. These firms employ (described below), TSA has tentatively aircraft. Therefore, in order to characterize an average of 64 individuals. Using the concluded that the proposed rule may estimate of $25 per badge cited in the impose a significant economic impact compliance costs as a percentage of Regulatory Evaluation, badges would on a substantial number of small repair station revenues, TSA estimated add an average of nearly $1,600 to these entities. The agency seeks comment on unit compliance costs based on repair stations’ compliance costs, this preliminary conclusion. weighted averages so as not to underestimate the costs of the rule. As resulting in a total cost of $6,328. Firms Compliance costs for the proposed a result, these estimates likely overstate having between 50 and 99 employees in rule would vary across firms. A small the costs to some small businesses while the Dun and Bradstreet sample reported business with one employee who only understating them for others. TSA average revenue of nearly $6 million. services one component of a particular welcomes comments that will assist it in The estimated compliance costs would aircraft may incur very low compliance more accurately estimating compliance therefore constitute less than one costs. Such a business is likely to be costs for small businesses. percent of their annual revenues. Since operated from a small shop or even a Using the assumptions and methods the proposed ID requirement would private residence. Conversely, a larger described above, TSA estimated the affect a subset of these repair stations— repair station that works on more average compliance costs to be about only those which are located on or complex systems or even entire aircraft $3,013 for a business with one employee adjacent to an airport—TSA does not may incur higher costs as a result of this to $4,216 for a business with 45 believe the proposed ID requirement NPRM. These types of facilities may be employees. Of this total, $2,733 located at an airport, in an industrial represents costs for security would result in a significant impact on park, or may be part of an aircraft coordinators, and $253 represents costs affected repair stations. manufacturing facility. For example, in for development and implementation of Table 32 below shows the distribution the ‘‘Cost of Compliance’’ section above, security programs. The remainder is of compliance costs, excluding ID costs, TSA estimated repair stations located on comprised of employee training costs. as a percent of repair station revenues.
TABLE 32—SMALL REPAIR STATION BUSINESS DISTRIBUTION OF COMPLIANCE COST-REVENUE RATIOS
Cumulative percentage of Compliance costs as a percentage of revenue Number of small businesses small businesses
≤1.0 ...... 692 32.6 ≤2.0 ...... 1,015 47.8 ≤3.0 ...... 1,527 71.9 ≤4.0 ...... 1,712 80.6 ≤5.0 ...... 1,759 82.9 ≤10.0 ...... 2,100 98.9
Total ...... 2,123 100.0
The table uses rounded percentages to alternatives. These alternatives included whether to exempt repair stations that show that TSA’s initial assessment is requiring security threat assessments for only perform maintenance on small that the NPRM may have a significant certain repair station employees and aircraft (aircraft having a maximum impact on a substantial number of small requiring each repair station to complete certificated takeoff weight of 12,500 businesses. TSA believes that for 47.8 a vulnerability self-assessment. Both of pounds or less). To help the agency percent of the small businesses, the these alternatives would have increased evaluate the impact of this alternative, compliance costs will result in an the burden on repair stations and thus TSA requests comments, supported by economic impact of two percent of on small entities. A description of these data, on the number of repair stations annual revenue or less, and for 71.9 alternatives and the reasons they were that work exclusively on such aircraft percent of the small businesses, the not adopted can be found in the section and their compliance costs under the compliance costs will be less than three of the Regulatory Evaluation titled, proposed rule. percent of annual revenue. TSA requests ‘‘Alternatives Considered.’’ Identification of Duplication, Overlap comment on these estimates. Additionally, as noted above, TSA requests comment on whether it should and Conflict With Other Federal Rules Significant Alternatives Considered exempt certain repair stations after it TSA has no knowledge of any During the course of drafting this conducts security reviews and audits. duplicative, overlapping, or conflicting NPRM, TSA considered regulatory For instance, TSA may consider Federal rules.
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Preliminary Conclusion inflation) in any one year by State, local, of the EPCA. TSA has also analyzed this Based on this preliminary analysis, and tribal governments, in the aggregate, proposed rule under E.O. 13211, TSA believes the proposed requirements or by the private sector; such a mandate ‘‘Actions Concerning Regulations That may result in a significant economic is deemed to be a ‘‘significant regulatory Significantly Affect Energy Supply, impact on a substantial number of small action.’’ This rulemaking does not Distribution, or Use,’’ 66 FR 28355 (May contain such a mandate. The entities. However, TSA holds a final 18, 2001). TSA has determined that this requirements of Title II of the Act, assessment in abeyance until such time is not a ‘‘significant energy action’’ therefore, do not apply. as information becomes available to under that order. facilitate the development of a Final D. Executive Order 13132, Federalism List of Subjects Regulatory Flexibility Analysis (FRFA). TSA has analyzed this proposed rule 49 CFR Part 1520 TSA requests comments, particularly under the principles and criteria of those supported by data, to inform this Executive Order 13132, Federalism. We Air carriers, Aircraft, Aircraft repair process. have determined that this action will stations, Airports, Maritime carriers, 4. International Trade Impact not have a substantial direct effect on Rail hazardous materials receivers, Rail Assessment the States, on the relationship between hazardous materials shippers, Rail the National Government and the States, transit systems, Railroad carriers, The Trade Agreement Act of 1979 or on the distribution of power and Railroad safety, Railroads, Reporting prohibits Federal agencies from responsibilities among the various and recordkeeping requirements, engaging in any standards or related levels of government, and therefore will Security measures, Vessels. activities that create unnecessary not have federalism implications. obstacles to the foreign commerce of the 49 CFR Part 1554 E. Environmental Analysis United States. Legitimate domestic Aircraft, Aircraft repair stations, objectives, such as security, are not TSA has reviewed this action under Aviation safety, Reporting and considered unnecessary obstacles. The DHS Management Directive 5100.1, recordkeeping requirements, Security statute also requires consideration of Environmental Planning Program measures. international standards and, where (effective April 19, 2006) which guides appropriate, that they be the basis for TSA compliance with the National The Proposed Amendment U.S. standards. In addition, it is the Environmental Policy Act of 1969 In consideration of the foregoing, the policy of TSA to remove or diminish, to (NEPA) (42 U.S.C. 4321–4347). TSA has Transportation Security Administration the extent feasible, barriers to determined that this proposal is covered proposes to amend Chapter XII of Title international trade, including both by the following categorical exclusions 49, Code of Federal Regulations, to read barriers affecting the export of American (CATEX) listed in the DHS directive: as follows: goods and services to foreign countries Number A3(a) (administrative and and barriers affecting the import of regulatory activities involving the Subchapter B—Security Rules for All foreign goods and services into the U.S. promulgation of rules and the Modes of Transportation In keeping with U.S. obligations development of policies); paragraph A4 PART 1520—PROTECTION OF under the Convention on International (information gathering and data SENSITIVE SECURITY INFORMATION Civil Aviation, it is TSA’s policy to analysis); paragraph A7(d) (conducting comply with International Civil audits, surveys, and data collection of a 1. The authority citation for part 1520 Aviation Organization (ICAO) Standards minimally intrusive nature, to include continues to read as follows: and Recommended Practices where vulnerability, risk, and structural possible. TSA has determined that there integrity assessments of infrastructures); Authority: 46 U.S.C. 70102–70106, 70117; are no ICAO Standards and paragraph B3 (proposed activities and 49 U.S.C. 114, 40113, 44901–44907, 44913– Recommended Practices that 44914, 44916–44918, 44935–44936, 44942, operations to be conducted in existing 46105. correspond to the regulatory standards structures that are compatible with established by this notice of proposed ongoing functions); paragraph B11 2. In § 1520.5, revise paragraph rulemaking (NPRM). TSA has assessed (routine monitoring and surveillance (b)(1)(i) to read as follows: the potential effect of this NPRM and activities that support homeland § 1520.5 Sensitive security information. has determined that it is unlikely it security, such as patrols, investigations, would create barriers to international and intelligence gathering), and H1 * * * * * trade. The full evaluation provides an (approval or disapproval of security (b) * * *; analysis of a number of issues directly plans required under legislative (1) * * *; related to international trade that were mandates where such plans do not have (i) Any aircraft operator, airport considered with this proposed rule. a significant effect on the environment). operator, fixed base operator, repair 5. Unfunded Mandates Reform Act In addition, TSA has determined that station, or air cargo security program, or Assessment this proposal meets the three conditions security contingency plan under this required for a CATEX to apply, as chapter; The Unfunded Mandates Reform Act described in paragraph 3.2, (Conditions of 1995 is intended, among other things, and Extraordinary Circumstances). * * * * * to curb the practice of imposing 3. In § 1520.7, add paragraph (o) to unfunded Federal mandates on State, F. Energy Impact Analysis read as follows: local, and tribal governments. Title II of The energy impact of this NPRM has the Act requires each Federal agency to been assessed in accordance with the § 1520.7 Covered persons. prepare a written statement assessing Energy Policy and Conservation Act * * * * * the effects of any Federal mandate in a (EPCA) Public Law 94–163, as amended (o) Each operator or owner of an proposed or final agency rule that may (42 U.S.C. 6362). TSA has determined aircraft repair station required to have a result in a $100 million or more that this rulemaking is not a major security program under part 1554 of this expenditure (adjusted annually for regulatory action under the provisions chapter.
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Subchapter C—Civil Aviation Security § 1554.5 TSA inspection authority. (b) Repair station profile. No later (a) General. Each repair station must than 30 calendar days after final rules PART 1554—AIRCRAFT REPAIR allow TSA and other authorized DHS are published in the Federal Register or STATION SECURITY officials, at any time and in a reasonable no later than 30 calendar days after FAA Subpart A—General manner, without advance notice, to certification, each repair station must enter, conduct any audits, assessments, submit a profile in a manner prescribed Sec. 1554.1 Scope and purpose. tests, or inspections of any property, by TSA. Each repair station must report 1554.3 Terms used in this part. facilities, equipment, and operations; changes in profile information as 1554.5 TSA inspection authority. and to view, inspect, and copy records specified by TSA within 30 calendar as necessary to carry out TSA’s security- days of the date of the change. Subpart B—Security Program related statutory or regulatory (c) Repair station security program. 1554.101 Adoption and implementation. authorities, including its authority to— Unless otherwise authorized by TSA, 1554.103 Security Program content, (1) Assess threats to transportation each repair station must use the TSA availability, and amendment. security; standard repair station security 1554.105 Security Directives. (2) Enforce security-related program. Subpart C—Compliance and Enforcement regulations, directives, and requirements; § 1554.103 Security program content, 1554.201 Notification of security availability, and amendment. deficiencies; suspension of certificate. (3) Inspect, maintain, and test security 1554.203 Immediate risk to security; facilities, equipment, and systems; (a) Content of security program. Each revocation of certificate and review (4) Ensure the adequacy of security security program must— process. measures; (1) Include measures to identify all 1554.205 Nondisclosure of certain (5) Verify the implementation of individuals who are authorized to enter information. security measures; the repair station to prevent Authority: 49 U.S.C. 114, 40113, 44903, (6) Review security programs; and, unauthorized individuals from entering 44924. (7) Carry out such other duties, and the repair station. exercise such other powers, relating to (2) Include measures to control access Subpart A—General transportation security as the Assistant to the repair station. Such measures must be designed to prevent, detect and § 1554.1 Scope and purpose. Secretary of Homeland Security for the TSA considers appropriate, to the extent resolve any unauthorized entry, This part applies to domestic and authorized by law. presence, and movement of individuals foreign repair stations that are (b) Evidence of compliance. At the and vehicles into or within the repair certificated by the Federal Aviation request of TSA, each repair station station. Administration pursuant to 14 CFR part operator must provide evidence of (3) Include measures to control access 145 except for a repair station compliance with its security program to the aircraft and aircraft components certificated by the Federal Aviation and with this part, including copies of to allow only authorized individuals to Administration at which the U.S. records. have access to the aircraft and aircraft Government has assumed responsibility (1) All records required under this components within the repair station. for security. The purpose of this part is part must be available in English. (4) Include measures to challenge any to provide for the security of (2) All responses and submissions individual entering the repair station or maintenance and repair work conducted provided to TSA or its designee, who is present in the repair station to on aircraft and aircraft components at pursuant to this part, must be in ascertain the authority of that individual domestic and foreign repair stations, of English, unless otherwise requested by to enter or be present in the area and the aircraft and aircraft components TSA. measures to escort an unauthorized located at the repair stations, and of the (c) Access to repair station. (1) TSA individual while within the repair repair station facilities, as required in 49 and DHS officials working with TSA station. U.S.C. 44924. may enter, without advance notice, and (5) Include measures to conduct initial and recurrent security training of § 1554.3 Terms used in this part. be present within any area without access media or identification media all individuals with authorized access to In addition to the terms in §§ 1500.3 issued or approved by the repair station aircraft and components on the and 1540.5 of this chapter, the following in order to inspect, test, or perform any provisions of this part and the security terms apply in this part: other such duties as TSA may direct. program and to maintain a record of Repair station means a domestic or (2) Repair stations may request TSA training completed by each employee. foreign facility certificated by the inspectors and DHS officials working (6) Include measures to verify Federal Aviation Administration with TSA to present their credentials for employee background information pursuant to 14 CFR part 145 that is examination, but the credentials may through confirmation of prior authorized to perform maintenance, not be photocopied or otherwise employment and any other means as preventive maintenance, or alterations reproduced. appropriate to validate employee of an aircraft, airframe, aircraft engine, information. propeller, appliance, or component part. Subpart B—Security Program (7) Include the name, means of (1) Domestic repair station means a contact on a 24 hour basis, duties, and repair station located within the fifty § 1554.101 Adoption and implementation. training requirements of the security States, the District of Columbia, or the (a) General. Each repair station must coordinator(s) who will serve as the territories and possessions of the United adopt and carry out a security program primary and immediate contact for States. to safeguard aircraft and aircraft security-related activities and (2) Foreign repair station means a components located within the repair communications with TSA. repair station located outside the fifty station and its facilities, the repair and (8) Include a contingency plan. States, the District of Columbia, or the maintenance work conducted at the (9) Include a diagram with territories and possessions of the United repair station, and the repair station dimensions detailing boundaries and States. facility itself. physical features of the repair station.
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(10) Include a list and description of (2) Refuse to release the Security the FAA in accordance with this all repair station entry points. Directive or the information contained paragraph. (11) Include an emergency response in the document to persons other than (1) TSA considers the initial contact list. those who have an operational need to notification, the repair station’s reply, (12) Be in writing and signed by the know without the prior written consent and any other relevant materials before operator, owner, or any person of TSA. issuing the Final Determination. delegated authority in this matter. (2) If TSA determines that security (b) Availability. (1) The repair station Subpart C—Compliance and deficiencies exist and have not been security program must— Enforcement addressed, TSA serves upon the repair (i) Be written both in English and in station and the FAA a Final the official language of the repair § 1554.201 Notification of security deficiencies; suspension of certificate. Determination. The Final Determination station’s country. shall include a statement that TSA has (ii) Be accessible at each facility. (a) General. Each repair station that reviewed all of the relevant information (2) Each repair station must restrict does not establish and carry out a available and has determined that the the distribution, disclosure, and security program, as specified in this repair station is not in compliance with availability of sensitive security part, may be subject to suspension of its this section. information (SSI) as defined in part FAA certificate, as provided by 49 (3) If TSA determines that security 1520 of this chapter to persons with a U.S.C. 44924(c)(1). deficiencies do not exist or have been need to know and refer all requests for (b) Notice of security deficiencies. corrected in a manner consistent with SSI by other persons to TSA. TSA provides written notification to a the requirements of this part, TSA (c) Amendment. (1) A repair station repair station and to the FAA of any notifies the repair station and the FAA must notify TSA of any amendment to security deficiency identified by TSA. the standard security program. that the repair station’s certification may (2) If TSA finds that there is a (c) Response. A repair station must be reinstated. situation requiring immediate action to provide TSA with a written explanation in English of all efforts, methods, and § 1554.203 Immediate risk to security; respond to a security threat, TSA may revocation of certificate and review issue an emergency amendment to the procedures used to correct the security process. deficiencies identified by TSA within standard security program. TSA will (a) Notice. TSA determines whether 45 days of receipt of the written provide an explanation of the reason for any repair station poses an immediate notification described in paragraph (b) the amendment. Each repair station risk to security. If such a determination of this section. must acknowledge receipt and adopt the is made, TSA provides written emergency amendment within the time (d) Suspension of certificate. If the notification of its determination to the prescribed. If a repair station is unable repair station does not correct security repair station and to the FAA that the to implement the emergency deficiencies within 90 days of the repair certificate must be revoked. The amendment, the repair station station’s receipt of the written notice of notification includes an explanation of immediately must notify TSA to obtain security deficiencies, or if TSA the basis for the revocation. TSA does approval of alternative measures. determines that the security deficiencies not include classified information or have not been addressed sufficiently to § 1554.105 Security Directives. other information described in comply with this section, TSA provides paragraph (e) of this section. (a) General. When TSA determines written notification to the repair station that additional security measures are (b) Request for review. Not later than and to the FAA that the station’s 30 days after receipt of the notice, a necessary to respond to a threat certificate shall be suspended. The assessment or to a specific threat against repair station may file a request for notification includes an explanation of review of the determination that the civil aviation, TSA issues a Security the basis for the suspension. The Directive setting forth mandatory repair station poses an immediate risk to suspension remains in place until such security. The revocation remains in measures. time as TSA determines that the (b) Compliance. Each repair station effect until the review is complete. The security deficiencies have been request must be made in writing, in required to have a security program corrected. must comply with each Security English, signed by the repair station (e) Reply. No later than 20 calendar Directive TSA issues to the repair operator or owner, and include— days after the date of receipt of the station within the time prescribed. Each (1) A statement that a review is notification of suspension, the repair repair station that receives a Security requested; and station may serve upon TSA a written Directive must— (2) A response to the determination of (1) Verbally acknowledge receipt of request for review of the basis for the immediate risk to security, including the Security Directive. determination that the security any information TSA should consider in (2) Specify the method by which deficiencies have not been addressed reviewing the basis for the security measures have been or will be sufficiently. The request must be in determination. implemented to meet the effective date. English and may include any (c) TSA Review. Not later than 30 (3) Notify TSA to obtain approval of information that the repair station calendar days, or such longer period as alternative measures, if the repair believes TSA should consider regarding TSA may determine for good cause, station is unable to implement the its determination. The suspension after TSA receives the repair station’s measures in the Security Directive. remains in effect until the review is request for review, TSA examines the (c) Availability. Each repair station complete. basis for the determination that the that receives a Security Directive and (f) TSA Review. Not later than 30 repair station poses an immediate risk to each person who receives information calendar days, or such longer period as security, the repair station’s response, from a Security Directive must— TSA may determine for good cause, and any other relevant materials. (1) Restrict the availability of the after TSA receives the repair station’s (d) Final determination. If TSA Security Directive and the information request for review, TSA reviews its determines that the repair station poses contained in the document to persons initial determination and issue a Final an immediate risk to security, the TSA who have an operational need to know. Determination on the repair station and Assistant Secretary or his or her
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designee reviews the notification, the of the relevant information available disclose classified information, as materials upon which the notification and has determined that the repair defined in Executive Order 12968 was based, the repair station’s response station poses an immediate risk to section 1.1(d), and TSA reserves the and any other available information. If security. If TSA determines that the right not to disclose any other the TSA Assistant Secretary or his or repair station does not pose an information or material not warranting her designee determines that the repair immediate risk to security, TSA notifies disclosure or protected from disclosure station continues to pose an immediate the repair station and the FAA. A Final under law or regulation. risk to security, the TSA Assistant Determination constitutes a final agency Issued in Arlington, Virginia, on November Secretary or his or her designee submits action for purposes of 49 U.S.C. 46111. 12, 2009. to the repair station and to the FAA a Final Determination. The Final § 1554.205 Nondisclosure of certain Gale Rossides, Determination includes a statement that information. Acting Administrator. the TSA Assistant Secretary or his or In connection with the procedures [FR Doc. E9–27624 Filed 11–17–09; 8:45 am] her designee personally has reviewed all under this subpart, TSA does not BILLING CODE 9110–05–P
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Reader Aids Federal Register Vol. 74, No. 221 Wednesday, November 18, 2009
CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING NOVEMBER
Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. Presidential Documents 10 CFR 2 CFR Executive orders and proclamations 741–6000 Proposed Rules: The United States Government Manual 741–6000 382...... 58189 430...... 56928, 58915 Other Services 431...... 57738 3 CFR Electronic and on-line services (voice) 741–6020 12 CFR Privacy Act Compilation 741–6064 Proclamations: 205...... 59033 Public Laws Update Service (numbers, dates, etc.) 741–6043 8444...... 57225 229...... 58537 TTY for the deaf-and-hard-of-hearing 741–6086 8445...... 57227 8446...... 57229 327...... 59056 8447...... 57231 360...... 59066 ELECTRONIC RESEARCH 8448...... 57233 13 CFR World Wide Web 8449...... 57235 126...... 56699 Full text of the daily Federal Register, CFR and other publications 8450...... 57237 is located at: http://www.gpoaccess.gov/nara/index.html 8451...... 58529 14 CFR Federal Register information and research tools, including Public 8452...... 58531 8453...... 59473 23...... 57060 Inspection List, indexes, and links to GPO Access are located at: 25...... 56702, 56706 http://www.archives.gov/federallregister Executive Orders: 39 ...... 56710, 56713, 56717, 13183 (amended by E-mail 57402, 57405, 57408, 57411, 13517) ...... 57239 57559, 57561, 57564, 57567, FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 13462 (amended by 57571, 57574, 57577, 57578, an open e-mail service that provides subscribers with a digital 13516) ...... 57241 58191, 58195, 58539 form of the Federal Register Table of Contents. The digital form 13494 (amended by 71...... 57246, 59475 of the Federal Register Table of Contents includes HTML and 13517) ...... 57239 97...... 58200, 58202 PDF links to the full text of each document. 13516...... 56521, 57241 1245...... 59476 13517...... 57239 To join or leave, go to http://listserv.access.gpo.gov and select Proposed Rules: 13518...... 58533 Online mailing list archives, FEDREGTOC-L, Join or leave the list 1...... 58918 (or change settings); then follow the instructions. Administrative Orders: 23...... 58918 Memorandums: PENS (Public Law Electronic Notification Service) is an e-mail 39 ...... 56748, 57264, 57266, Memo. of Nov. 5, service that notifies subscribers of recently enacted laws. 57268, 57271, 57273, 57277, 2009 ...... 57881 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 58919, 59480, 59483, 59488 Notices: 71 ...... 57616, 57617, 57618, and select Join or leave the list (or change settings); then follow Notice of Nov. 6, the instructions. 57620, 57621, 58569, 58570, 2009 ...... 58187 58571, 58573, 59491, 59492 FEDREGTOC-L and PENS are mailing lists only. We cannot Notice of November respond to specific inquiries. 12, 2009 ...... 58841 15 CFR Reference questions. Send questions and comments about the 744...... 57061 Federal Register system to: [email protected] 5 CFR 774...... 57581 The Federal Register staff cannot interpret specific documents or Proposed Rules: Proposed Rules: regulations. 731...... 56747 922...... 58923 1604...... 57125 Reminders. Effective January 1, 2009, the Reminders, including 1651...... 57125 16 CFR Rules Going Into Effect and Comments Due Next Week, no longer 1653...... 57125 Proposed Rules: appear in the Reader Aids section of the Federal Register. This 1690...... 57125 305...... 57950 information can be found online at http://www.regulations.gov. CFR Checklist. Effective January 1, 2009, the CFR Checklist no 7 CFR 17 CFR longer appears in the Federal Register. This information can be 11...... 57401 4...... 57585 found online at http://bookstore.gpo.gov/. 301...... 57243 211...... 57062 319...... 56523 248...... 58204 FEDERAL REGISTER PAGES AND DATE, NOVEMBER 354...... 57057 18 CFR 966...... 57057 56521–56692...... 2 375...... 57246 983...... 56526, 565231 56693–57056...... 3 984...... 56693 57057–57238...... 4 19 CFR 987...... 56697 57239–57400...... 5 Proposed Rules: 1710...... 56542 57401–57558...... 6 113...... 57125 57559–57882...... 9 Proposed Rules: 191...... 57125 57883–58188...... 10 457...... 59108 20 CFR 58189–58532...... 12 920...... 58216 58533–58842...... 13 1710...... 56569 655...... 59069 58843–59032...... 16 1910...... 57883 59033–59472...... 17 9 CFR Proposed Rules: 59473–59890...... 18 78...... 57245 404 ...... 57970, 57971, 57972
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21 CFR 59476, 59477 63...... 58574 57104, 57260, 58851 165 ...... 57070, 57415, 57886, 73...... 57248, 58843 70...... 57126 Proposed Rules: 57888, 58211, 58545, 59098 528...... 58205 71...... 57126 36...... 57982 334...... 58846, 58848 529...... 59073 271...... 59497 54...... 57982 Proposed Rules: 300...... 58575 73 ...... 57281, 57282, 57283, Proposed Rules: 117 ...... 57975, 58931, 58933 4...... 57973 721...... 57430 58936 161...... 58223 1308...... 59108 1515...... 58576 165...... 57427, 58223 48 CFR 26 CFR 42 CFR 34 CFR 34...... 56547 3009...... 58851 1 ...... 57251, 57252, 59074, Ch. 11...... 58436, 59688 3052...... 58851 59087 52...... 57918 Proposed Rules: 602...... 57252 38 CFR 409...... 58078 424...... 58078 3...... 58584 Proposed Rules: 3...... 57072, 58232 484...... 58078 52...... 58584 1...... 58574 9...... 59478 Proposed Rules: 53...... 58574 200...... 57608 84...... 59501 49 CFR 28 CFR 410...... 57127 39 CFR 234...... 58560 413...... 57127 2...... 58540 20...... 57890 564...... 58213 414...... 57127 111...... 57899 29 CFR 571...... 58213, 58562 3001...... 57252 44 CFR Proposed Rules: 2550...... 59092 3004...... 57252 234...... 58589 4001...... 59093 3020...... 56544 65...... 57921 67 ...... 57923, 57928, 57944 571...... 57623 4022...... 58544, 59093 Proposed Rules: 206...... 58849 580...... 59503 Proposed Rules: 111...... 59494 633...... 57986 1202...... 56750, 57427 3050...... 57280 Proposed Rules: 1520...... 59874 67...... 57979 1206...... 56750, 57427 1554...... 59874 1910...... 57278, 57976 40 CFR 45 CFR 1915...... 57278 3...... 59104 1926...... 57278 51...... 56721 82...... 58189 50 CFR 52 ...... 56721, 57048, 57051, 17...... 56978, 59444 31 CFR 57074, 57612, 57904, 57907, 46 CFR 20...... 57615 103...... 59096 58553 10...... 59354 229...... 58859 285...... 56719 81...... 58687 11...... 59354 300...... 57105 501...... 57593 112...... 58783 12...... 59354 622...... 57261, 58902 Proposed Rules: 141...... 57908 15...... 59354 648...... 56562, 58567 103...... 58926 180 ...... 57076, 57078, 57081, Proposed Rules: 660...... 57117, 57425 59608 10...... 59502 679 ...... 56728, 56734, 57262, 32 CFR 261...... 57418 11...... 59502 57949, 59106, 59479 239...... 58846 300...... 57085, 58554 12...... 59502 Proposed Rules: 311...... 58205 721...... 57424 15...... 59502 17 ...... 56757, 56770, 57804, 806b...... 57414 Proposed Rules: 540...... 56756 57987 Proposed Rules: 51...... 57126 222...... 59508 806b...... 57427 52 ...... 56754, 57049, 57055, 47 CFR 223...... 57436 57126, 57622, 57978, 59496 2...... 57092 224...... 57436 33 CFR 60...... 58574 25...... 57092 635...... 57128 117 ...... 57884, 58209, 58210, 61...... 58574 73 ...... 56726, 56727, 57103, 648...... 57134, 58234
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Register but may be ordered S. 509/P.L. 111–98 enacted public laws. To in ‘‘slip law’’ (individual To authorize a major medical subscribe, go to http:// LIST OF PUBLIC LAWS pamphlet) form from the facility project at the listserv.gsa.gov/archives/ Superintendent of Documents, Department of Veterans Affairs publaws-l.html This is a continuing list of U.S. Government Printing Medical Center, Walla Walla, public bills from the current Office, Washington, DC 20402 Washington, and for other session of Congress which (phone, 202–512–1808). The purposes. (Nov. 11, 2009; 123 Note: This service is strictly have become Federal laws. It text will also be made Stat. 3010) for E-mail notification of new may be used in conjunction available on the Internet from Last List November 10, 2009 laws. The text of laws is not with ‘‘P L U S’’ (Public Laws GPO Access at http:// available through this service. Update Service) on 202–741– www.gpoaccess.gov/plaws/ PENS cannot respond to 6043. This list is also index.html. Some laws may Public Laws Electronic specific inquiries sent to this available online at http:// not yet be available. Notification Service address. www.archives.gov/federal- (PENS) register/laws.html. S. 475/P.L. 111–97 Military Spouses Residency The text of laws is not Relief Act (Nov. 11, 2009; 123 PENS is a free electronic mail published in the Federal Stat. 3007) notification service of newly
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