5–26–04 Wednesday Vol. 69 No. 102 May 26, 2004

Pages 29845–30150

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1 II Federal Register / Vol. 69, No. 102 / Wednesday, May 26, 2004

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2 III

Contents Federal Register Vol. 69, No. 102

Wednesday, May 26, 2004

Administration on Aging See International Trade Administration See Aging Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Agency for International Development See Technology Administration NOTICES NOTICES Agency information collection activities; proposals, Agency information collection activities; proposals, submissions, and approvals, 29918 submissions, and approvals, 29918–29919

Aging Administration Corporation for National and Community Service NOTICES NOTICES Grants and cooperative agreements; availability, etc.: Agency information collection activities; proposals, Pension Counseling and Information Program, 29949– submissions, and approvals, 29930 29950

Agricultural Marketing Service Defense Department PROPOSED RULES See Navy Department Research and promotion programs: Organic producers and marketers; exemption from Drug Enforcement Administration assessments for research and promotion activities, NOTICES 29907 Applications, hearings, determinations, etc.: Boehringer Ingelheim Chemicals, Inc., 29978–29979 Agriculture Department Varian, Inc., 29979 See Agricultural Marketing Service Education Department Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES NOTICES Agency information collection activities; proposals, Agency information collection activities; proposals, submissions, and approvals, 29932–29933 submissions, and approvals, 29978 Special education and rehabilitative services: Special demonstration programs; positive psychology Arts and Humanities, National Foundation model demonstration projects, 30137–30140 See National Foundation on the Arts and the Humanities Employee Benefits Security Administration Census Bureau RULES NOTICES Group health plans; access, portability, and renewability Agency information collection activities; proposals, requirements: submissions, and approvals, 29919–29920 Health care continuation coverage, 30083–30112 NOTICES Centers for Disease Control and Prevention Meetings: NOTICES Employee Welfare and Pension Benefit Plans Advisory Grants and cooperative agreements; availability, etc.: Council, 29979–29980 Spina bifida information and resource development programs, 29950–29953 West Nile virus infection effect on human pregnancy Energy Department outcomes, 29953–29957 See Federal Energy Regulatory Commission Meetings: NOTICES Healthcare Infection Control Practices Advisory Electricity export and import authorizations, permits, etc.: Committee; correction, 29958 UBS AG, London Branch, 29933–29934 Tuberculosis Elimination Advisory Council, 29958 Environmental statements; availability, etc.: Baja California Power, Inc. and Sempra Energy Resources Centers for Medicare & Medicaid Services Transmission Lines; hearings, 29934 NOTICES Privacy Act: Environmental Protection Agency Computer matching programs, 29958–29959 RULES Air quality implementation plans; approval and Coast Guard promulgation; various States: RULES California, 29880–29882, 30005–30036 Drawbridge operations: North Carolina, 30037–30040 Texas, 29864–29865 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Commerce Department Imidacloprid, 30041–30081 See Census Bureau Isoxadifen-ethyl, 29882–29890 See Industry and Security Bureau Ultramarine blue, 29890–29894

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PROPOSED RULES Federal Maritime Commission Air quality implementation plans; approval and NOTICES promulgation; various States: Ocean transportation intermediary licenses: California, 29913 Best International Shipping, Inc., et al., 29947 NOTICES CTSI Logistics, Inc., et al., 29947–29948 Meetings: IFF, Inc., et al., 29948 Acute Exposure Guideline Levels for Hazardous Substances National Advisory Committee, 29939– Federal Reserve System 29940 NOTICES Pesticide, food, and feed additive petitions: Banks and bank holding companies: K-I Chemical U.S.A., Inc., 29940–29945 Formations, acquisitions, and mergers, 29948–29949 Reports and guidance documents; availability, etc.: Permissible nonbanking activities, 29949 Pesticides— MGK Repellent 326; registration eligibility decision, Federal Retirement Thrift Investment Board 29945–29947 RULES Thrift Savings Plan: Executive Office of the President Funds withdrawal; court orders and legal processes, and See Presidential Documents loan program, 29849–29852

Farm Credit Administration Food and Drug Administration RULES PROPOSED RULES Farm credit system: Public health security and bioterrorism: Loan policies and operations, etc.— Food importation; sampling services and private Other financial institutions; funding access, 29852– laboratories requirements 29863 Correction, 29912 NOTICES Federal Aviation Administration Reports and guidance documents; availability, etc.: PROPOSED RULES BA and BE testing samples; handling and retention, Airworthiness directives: 29959–29960 Raytheon, 29910–29912 Airworthiness standards: Geological Survey Transport category airplanes— NOTICES Flight crew alerting, 29910 Patent licenses; non-exclusive, exclusive, or partially NOTICES exclusive: Aeronautical land-use assurance; waivers: Sequoia Scientific, Inc., 29970 Shenandoah Valley Regional Airport, VA, 30001–30002 Health and Human Services Department Federal Communications Commission See Aging Administration RULES See Centers for Disease Control and Prevention Common carrier services: See Centers for Medicare & Medicaid Services Satellite communications— See Food and Drug Administration International Bureau Filing System; electronic filing See Health Resources and Services Administration requirements, 29894–29903 See National Institutes of Health PROPOSED RULES See Substance Abuse and Mental Health Services Common carrier services: Administration Presubscribed interexchange carrier charges, 29913– 29917 Health Resources and Services Administration Radio stations; table of assignments: NOTICES California, 29917 Meetings: Maternal and Child Health Research Grants Review Federal Energy Regulatory Commission Committee, 29960 NOTICES Electric rate and corporate regulation filings, 29937–29938 Homeland Security Department Meetings: See Coast Guard KeySpan LNG, L.P.; Providence, RI; site visit, 29938 See Transportation Security Administration Off-the-record communications, 29938–29939 Applications, hearings, determinations, etc.: Housing and Urban Development Department Ameren Services Co., 29935 NOTICES Dominion Transmission, Inc., 29935 Agency information collection activities; proposals, National Fuel Gas Supply Corp., 29936 submissions, and approvals, 29969–29970 Questar Pipeline Co., 29936 Tennessee Gas Pipeline Co., 29936–29937 Industry and Security Bureau Trailblazer Pipeline Co., 29937 NOTICES Agency information collection activities; proposals, Federal Highway Administration submissions, and approvals, 29920 NOTICES Environmental statements; notice of intent: Interior Department Atchison County, KA and Buchanan County, MO, 30002 See Geological Survey

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See Reclamation Bureau National Institute on Alcohol Abuse and Alcoholism, See Surface Mining Reclamation and Enforcement Office 29963 National Institute on Drug Abuse, 29961–29962 International Trade Administration NOTICES National Oceanic and Atmospheric Administration Antidumping: RULES Brake rotors from— Fishery conservation and management: China, 29920–29921 West Coast States and Western Pacific fisheries— Freshwater crawfish tail meat from— Pacific whiting, 29905–29906 China, 29921–29922 NOTICES Glycine from— Agency information collection activities; proposals, China, 29922 submissions, and approvals, 29926–29927 Outboard engines from— Reports and guidance documents; availability, etc.: Japan, 29922–29923 Atlantic highly migratory species (Atlantic tunas, Stainless steel wire rods from— swordfish, and sharks) and Atlantic billfish fishery India, 29923–29925 management plans; amendments; meetings, 29927

International Trade Commission National Science Foundation NOTICES NOTICES Import investigations: Meetings: Automotive measuring devices, products containing Business and Operations Advisory Committee, 29981– same, and bezels, 29971 29982 Home vacuum packaging products, 29971–29972 Power amplifier chips, broadband turner chips, National Transportation Safety Board transceiver chips, and products containing same, NOTICES 29972 Meetings; Sunshine Act, 29982 Reports and guidance documents; availability, etc.: Administrative Protective Orders; summary of Navy Department commission practice, 29972–29978 NOTICES Environmental statements; record of decision: Justice Department Naval Air Weapons Station China Lake, CA, 29931–29932 See Alcohol, Tobacco, Firearms, and Explosives Bureau See Drug Enforcement Administration Nuclear Regulatory Commission NOTICES Labor Department Applications, hearings, determinations, etc.: See Employee Benefits Security Administration Duke Energy Corp., 29982–29983 NOTICES Nuclear Management Co., LLC, 29983–29984 Organization, functions, and authority delegations: Internal equal employment opportunity programs, 30133– Overseas Private Investment Corporation 30135 NOTICES National Credit Union Administration Agency information collection activities; proposals, PROPOSED RULES submissions, and approvals, 29984–29985 Credit unions: Meetings; Sunshine Act, 29985 Health savings accounts; Federal credit unions acting as trustees and custodians, 29907–29910 Patent and Trademark Office RULES National Foundation on the Arts and the Humanities Practice and procedure: NOTICES Power of attorney practice clarification and assignment Meetings: rules revisions, 29865–29880 Combined Arts Advisory Panel, 29980 Fellowships Advisory Panel, 29980 Presidential Documents Leadership Initiatives Advisory Panel, 29980–29981 PROCLAMATIONS Special observances: National Institute for Literacy National Maritime Day (Proc. 7789), 29845–29846 NOTICES National Safe Boating Week (Proc. 7790), 29847–29848 Meetings: Advisory Board, 29981 Reclamation Bureau NOTICES National Institutes of Health Environmental statements; availability, etc.: NOTICES Platte River Recovery Implementation Program, NE, Meetings: 29970–29971 National Eye Institute, 29960–29961 National Heart, Lung, and Blood Institute, 29961 Research and Special Programs Administration National Institute of Allergy and Infectious Diseases, RULES 29963–29964 Hazardous materials: National Institute of Nursing Research, 29961 Incident reporting requirements and incident report form; National Institute on Aging, 29962–29963 revisions; correction, 30113–30132

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Pipeline safety: Transportation Security Administration Hazardous liquid transportation— NOTICES Gas transmission pipelines; integrity management in Agency information collection activities; proposals, high consequence areas; correction, 29903–29904 submissions, and approvals, 29968–29969

Securities and Exchange Commission Treasury Department PROPOSED RULES NOTICES Securities: Agency information collection activities; proposals, National market system; joint industry plans; submissions, and approvals, 30002–30003 amendments, 30141–30149 NOTICES Self-regulatory organizations; proposed rule changes: Separate Parts In This Issue Chicago Stock Exchange, Inc., 29986–29989 National Association of Securities Dealers, Inc., 29990– Part II 29997 Environmental Protection Agency, 30005–30036 New York Stock Exchange, Inc., 29998 Pacific Exchange, Inc., 29999–30000 Part III Philadelphia Stock Exchange, Inc., 30000–30001 Environmental Protection Agency, 30037–30040 Applications, hearings, determinations, etc.: Atlas Pipeline Partners, L.P., 29985–29986 Part IV Bentley Pharmaceuticals, Inc., 29986 Environmental Protection Agency, 30041–30081

Substance Abuse and Mental Health Services Part V Administration Labor Department, Employee Benefits Security NOTICES Administration, 30083–30112 Grants and cooperative agreements; availability, etc.: Mental Health Services Center— Part VI Networking and Certifying Suicide Prevention Hotlines, Transportation Department, Research and Special Programs 29964–29968 Administration, 30113–30132 Part VII Surface Mining Reclamation and Enforcement Office Labor Department, 30133–30135 RULES Permanent program and abandoned mine land reclamation Part VIII plan submissions: Education Department, 30137–30140 Missouri Correction, 29864 Part IX Securities and Exchange Commission, 30141–30149 Technology Administration NOTICES Business development missions: Reader Aids Northern Ireland and Republic of Ireland; senior-level Consult the Reader Aids section at the end of this issue for U.S. technology-sector leaders; applications request, phone numbers, online resources, finding aids, reminders, 29928–29930 and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents Transportation Department LISTSERV electronic mailing list, go to http:// See Federal Aviation Administration listserv.access.gpo.gov and select Online mailing list See Federal Highway Administration archives, FEDREGTOC-L, Join or leave the list (or change See Research and Special Programs Administration 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 73...... 29917 Proclamations: 49 CFR 7789...... 29845 192...... 29903 7790...... 29847 50 CFR 5 CFR 660...... 29905 1650...... 29849 1653...... 29849 1655...... 29849 1690...... 29849 7 CFR Proposed Rules: 1150...... 29907 1160...... 29907 1205...... 29907 1207...... 29907 1209...... 29907 1210...... 29907 1215...... 29907 1216...... 29907 1218...... 29907 1219...... 29907 1220...... 29907 1230...... 29907 1240...... 29907 1250...... 29907 1260...... 29907 1280...... 29907 12 CFR 614...... 29852 615...... 29852 Proposed Rules: 721...... 29907 724...... 29907 14 CFR Proposed Rules: 25...... 29910 39...... 29910 17 CFR Proposed Rules: 200...... 30142 230...... 30142 240...... 30142 242...... 30142 249...... 30142 21 CFR Proposed Rules: 59...... 29912 29 CFR 2590...... 30084 30 CFR 925...... 29864 33 CFR 117...... 29864 37 CFR 1...... 29865 3...... 29865 5...... 29865 40 CFR 52 (3 documents) ...... 29880, 30006, 30038 180 (4 documents) ...... 29882, 29890, 30042, 30076 Proposed Rules: 52...... 29913 47 CFR 1...... 29894 25...... 29894 63...... 29894 64...... 29894 Proposed Rules: Ch. I ...... 29913

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Federal Register Presidential Documents Vol. 69, No. 102

Wednesday, May 26, 2004

Title 3— Proclamation 7789 of May 21, 2004

The President National Maritime Day, 2004

By the President of the United States of America

A Proclamation

National Maritime Day provides an opportunity to recognize the men and women of the United States Merchant Marine and their contributions to our national security and economic strength. Since they first offered their ships and services to assist the Continental Navy in our struggle for independence, to their distinguished service in World War II, merchant mariners have courageously sacrificed to protect our country and defend our freedoms. In 1936, America recognized the contributions of these patriots and established the U.S. Merchant Marine ‘‘as a naval or military auxiliary in time of war or national emergency.’’ Today, merchant mariners are delivering essential supplies and equipment to our troops in Iraq and bravely serving the cause of liberty. They continue to play an important role in our Nation’s efforts to advance democracy, peace, and freedom around the world, and we are grateful for their dedication. Merchant mariners also contribute significantly to the U.S. maritime transpor- tation system. More than 95 percent of non-North American trade enters our country through our seaports. These ports handle more than $740 billion and 2 billion tons of domestic and international freight each year. Those in the maritime industry, including merchant mariners, enhance waterborne commerce and help promote America’s economic growth. Today, we honor the courage, determination, and service of our Nation’s merchant mariners and remember the many who have given their lives in defense of our country. Their work reflects the patriotism and devotion to duty that make America great. In recognition of the importance of the U.S. Merchant Marine, the Congress, by joint resolution approved on May 20, 1933, as amended, has designated May 22 of each year as ‘‘National Maritime Day,’’ and has authorized and requested that the President issue an annual proclamation calling for its appropriate observance. NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America, do hereby proclaim May 22, 2004, as National Maritime Day. I call upon the people of the United States to celebrate this observance and to display the flag of the United States at their homes and in their communities. I also request that all ships sailing under the American flag dress ship on that day.

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IN WITNESS WHEREOF, I have hereunto set my hand this twenty-first day of May, in the year of our Lord two thousand four, and of the Independ- ence of the United States of America the two hundred and twenty-eighth. W

[FR Doc. 04–12071 Filed 5–25–04; 8:45 am] Billing code 3195–01–P

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Proclamation 7790 of May 21, 2004

National Safe Boating Week, 2004

By the President of the United States of America

A Proclamation

Our Nation’s many waterways give millions of boating enthusiasts the oppor- tunity to enjoy the outdoors and spend time with family and friends. With nearly 13 million recreational boats on our oceans, lakes, and rivers, boating is a popular pastime. However, far too many Americans are hurt or killed each year in boating accidents that are largely preventable. Each year, of the thousands of boating accidents that occur, many are caused by operators who are careless, reckless, or inexperienced. In most cases, boat operators had received no safety instruction, and many of those who died could have been saved if they had worn life jackets. During National Safe Boating week, we seek to raise awareness to improve safety and reduce accidents on our Nation’s waters. Across the Nation, many groups are working to teach recreational boaters how they can make boating safer through the 2004 North American Safe Boating Campaign. These include the U.S. Coast Guard, the Coast Guard Auxiliary, the National Safe Boating Council, and the National Association of State Boating Law Administrators. These groups recommend that boaters get boat safety checks, ensure that boats are properly maintained, take safe boating classes, be aware of homeland security issues, always wear a life jacket, and never operate a boat under the influence of alcohol or drugs. By learning about boating safety and taking some simple precautions, rec- reational boaters can reduce the risk of accidents and ensure that they enjoy their time on the water responsibly. In recognition of the importance of safe boating practices, the Congress, by joint resolution approved June 4, 1958 (36 U.S.C. 131), as amended, has authorized and requested the President to proclaim annually the 7- day period prior to Memorial Day weekend as ‘‘National Safe Boating Week.’’ NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America, do hereby proclaim May 22 through May 28, 2004, as National Safe Boating Week. I encourage the Governors of the 50 States and the Commonwealth of Puerto Rico, and officials of other areas subject to the jurisdiction of the United States, to join in observing this occasion. I also urge all boaters to learn more about safe boating practices, always wear life jackets, and take advantage of boating safety programs throughout the year.

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IN WITNESS WHEREOF, I have hereunto set my hand this twenty-first day of May, in the year of our Lord two thousand four, and of the Independ- ence of the United States of America the two hundred and twenty-eighth. W

[FR Doc. 04–12072 Filed 5–25–04; 8:45 am] Billing code 3195–01–P

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Rules and Regulations Federal Register Vol. 69, No. 102

Wednesday, May 26, 2004

This section of the FEDERAL REGISTER TSP is similar to cash or deferred TSP accounts from dissipation by contains regulatory documents having general arrangements established for private- restricting the ability of anyone, applicability and legal effect, most of which sector employees under section 401(k) including the participant, to access the are keyed to and codified in the Code of of the Internal Revenue Code (26 U.S.C. money in the TSP. For example, a Federal Regulations, which is published under 401(k)). creditor generally cannot access the 50 titles pursuant to 44 U.S.C. 1510. On April 7, 2004, the Executive money in the participant’s account. The Code of Federal Regulations is sold by Director published this rule in proposed With respect to participants’ access, the Superintendent of Documents. Prices of form in the Federal Register (69 FR FERSA only allows in-service new books are listed in the first FEDERAL 18294). The Executive Director withdrawals in cases of financial REGISTER issue of each week. requested comments on the proposed hardship or, if the participant is still rule and received sixty-eight comments employed, on one occasion after on the loan program changes. One reaching 591⁄2. See 5 U.S.C. 8433(h). FEDERAL RETIREMENT THRIFT comment came from a Federal Congress also placed restrictions on INVESTMENT BOARD employees’ union, one came from a TSP loans to prevent the dissipation of commercial entity, and the remaining retirement savings. FERSA requires the 5 CFR Parts 1650, 1653, 1655 and 1690 came from TSP participants. The TSP to follow the Internal Revenue Methods of Withdrawing Funds From commercial entity asked the Board to Code provisions that apply to private the Thrift Savings Plan; Court Orders clarify proposed sections 1655.21, sector retirement plan loans. 5 U.S.C. and Legal Processes Affecting Thrift 1690.12 and 1690.13; they are clarified 8433(g)(3). Among other things, those Savings Plan Accounts; Loan in the final rule. One of the participants provisions set a maximum dollar Program; Thrift Savings Plan also commented favorably about the amount for loans, require continuous proposed changes to the court order, loan payments, require the TSP to AGENCY: Federal Retirement Thrift guardianship order, conservatorship charge interest on TSP loans, and limit Investment Board. order, and power of attorney the length of time over which a loan can ACTION: Final rule. regulations. be repaid. Initially, FERSA limited the reasons for which a loan could be taken; Union Comment SUMMARY: The Executive Director of the Congress eliminated this ‘‘purpose’’ test Federal Retirement Thrift Investment A Federal employees’ union in 1996 in favor of the current rule Board (Board) is amending the court commented that the Federal Employees’ allowing a general purpose loan. order regulations to remove attorneys Retirement System was designed to Therefore, it is incorrect to conclude from the list of permissible court order place more of the risk and financial that Congress gave participants ‘‘direct payees and to require non-English court burden of saving for retirement on the access’’ to the savings in their TSP orders to be accompanied by a certified Federal employees and that, in accounts ‘‘to use them as they see fit.’’ English translation. The Executive exchange, those employees receive FERSA states only that a participant Director is revising the TSP loan ‘‘direct access’’ to their retirement ‘‘may apply to the Board for permission regulations to assess a $50 fee on new savings ‘‘to use them as they see fit.’’ By to borrow from [his or her] account.’’ 5 TSP loans, restrict a participant to a making it more difficult and expensive U.S.C. 8433(g)(1). The Executive single general purpose loan at any time, for participants to use their own Director, therefore, must establish the and implement a 60-day waiting period savings, the union continued, the Board conditions under which a loan request between the date a participant repays a is ‘‘breaking a promise made to federal will be granted. 5 U.S.C. 8433(g)(2). loan and the date the TSP will accept an employees upon the inception of the Consistent with the purpose of the TSP, application for a new loan of the same Thrift Savings Plan.’’ The union these policies must promote saving for type. Finally, the Executive Director is concluded that the Board is attempting retirement. clarifying the regulations pertaining to to dictate the financial needs of The Executive Director has powers of attorney documents, participants beyond the current determined that the current loan guardianship orders, and reasonable loan restrictions. The union program has allowed many participants conservatorship orders. also wrote that with recent low to use the TSP as a source of ready cash, DATES: This final rule is effective July 1, mortgage rates, participants need TSP which can be detrimental to long-term 2004. loans to invest in real property. retirement savings. The Executive FOR FURTHER INFORMATION CONTACT: There can be no question that the Director concluded that it is appropriate Patrick J. Forrest on (202) 942–1661. money in the TSP belongs to the TSP to limit access to a TSP loan to reinforce SUPPLEMENTARY INFORMATION: The participants; however, the TSP was the importance of borrowing from the Executive Director administers the TSP, created by the Federal Employees’ TSP only as a last resort. which was established by the Federal Retirement System Act of 1986 (FERSA) With respect to the union’s comment Employees’ Retirement System Act of and exists to provide retirement income that participants need TSP loans to 1986 (FERSA), Pub. L. 99–335, 100 Stat. to participants and their beneficiaries. invest in real estate, the Executive 514. The TSP provisions of FERSA have To encourage the growth of TSP Director is not changing the rules been codified, as amended, largely at 5 accounts, Congress exempted TSP applicable to TSP residential loans. U.S.C. 8351 and 8401–79. The TSP is a contributions and earnings from Federal Finally, the union commented that a tax-deferred retirement savings plan for income taxation until they are $50 loan fee was inappropriate because Federal civilian employees and withdrawn from the TSP. Just as it makes the TSP loan program more members of the uniformed services. The importantly, Congress also protected expensive. The fee will not increase the

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expense of the loan program, except to One participant asked if the TSP prevent a participant from obtaining a the participant who obtains a loan. would charge the loan fee even if the TSP loan to pay such expenses. Rather, Currently, every participant pays the loan application were rejected. The loan the changes will limit a participant to a costs of administering the loan program, fee is not an application fee; it will single general purpose loan. This even those who have never taken a loan. cover the costs of processing and purpose of this limitation is to promote However, the Executive Director has servicing the loan. Therefore, as the use of the TSP as a retirement determined that the costs of the loan explained in final § 1655.21, the TSP savings plan and to reinforce the program should, instead, be borne by will deduct the loan fee from the loan importance of borrowing from the TSP the approximately 620,000 participants proceeds only when it issues a loan. as a last resort. The TSP is a retirement who use the TSP loan program, rather One participant also commented that savings plan, not a savings account that than by the 2.6 million participants who the TSP should only charge the loan fee should be used to finance short-term do not. By way of comparison, most once because a participant should only needs, refinance consumer debt or start private sector retirement plans charge pay for ‘‘underwriting’’ approval once. a business. A participant who may need loan fees. Of those that do, more than 70 There is no underwriting approval in money in the near future and who does percent charge a loan fee of $50 or more. the TSP loan program. not have adequate savings should In contrast, thirty-eight participants consider those short-term needs Participant Comments wrote that the loan fee is appropriate, carefully before deciding how much to Every comment received from a primarily because it will lower the cost contribute to the TSP. participant addressed the proposed $50 of administering the TSP to those who Several commenters who oppose loan fee. Thirty-one participants do not use the loan program. Some limiting participants to a single general objected to the proposed fee. Many participants asked the Board to charge a purpose loan also wrote that the TSP is wrote that the fee is unnecessary fee greater than $50 or to base the a necessary source of emergency funds because they assume (incorrectly) that amount of the fee on the dollar amount in the case of financial hardship. either the interest charged on TSP loans of the loan. The Board will not base the However, TSP funds remain available if pays for the expenses of the loan loan fee on the dollar amount of the a participant can qualify for financial program, that the Department of loan because the fee is intended only to hardship in-service withdrawals. Agriculture provides recordkeeping pay the administrative costs of a TSP Forty participants commented on the services for the TSP free of charge, or loan, which do not vary with the size of 60-day waiting period between paying that the Board receives an appropriation the loan. Several participants also off a loan and receiving another of the from Congress to pay the TSP’s suggested that the TSP eliminate the same type; thirty-one of them oppose administrative expenses. Other loan program altogether. The Board will the change. Those who stated a reason participants oppose the fee because they not eliminate the loan program because for opposing the change (other than assume the Board will use the extra it is an important benefit that the TSP those reasons discussed above) believe funds to hide TSP administrative is required by FERSA to provide. it unreasonably limits their ability to expenses or even that the Board will Some participants asked the Board to obtain a loan or is simply designed to divert the loan fees for non-TSP charge fees for other TSP transactions, discourage loans. purposes. As explained below, none of such as interfund transfers and in- Before proposing the 60 day waiting these assumptions is true. service withdrawals. The Executive period, the Executive Director Although the TSP charges each Director does not plan to charge undertook a study of the loan program; participant interest on his or her loan, transaction fees in addition to the loan that study revealed that an increasing the interest collected is deposited into fee; however, decreasing the cost of the number of participants repeatedly pay the participant’s account, it is not used program for participants is an important off one loan and simultaneously apply to pay TSP administrative expenses. 5 consideration and the Executive for another. These participants are CFR 1655.9(c). Furthermore, although Director does review all costs from time apparently using the TSP as an ongoing the TSP recordkeeper is a component of to time to determine whether they are vehicle for financing their living a Federal agency, its Congressional appropriate. expenses, rather than as a retirement appropriations do not pay the TSP’s Forty-three participants commented savings plan. The waiting period is administrative expenses. Rather, the on the Executive Director’s proposal to designed to correct this abusive Board pays the Department of limit participants to a single general practice. Agriculture for the cost of its services, purpose loan; thirty-three objected to The waiting period also solves an including the costs of administering the the change. Most wrote that the Board administrative problem. Many TSP loan program. The Board does not should not impose any restrictions on participants simultaneously submit a receive an annual appropriation to pay their ability to use their own money. As new loan application with a loan payoff these expenses, or any other TSP explained in the answer to the union check. In such a case, the TSP cannot expense; rather, the Board pays all TSP comment, the Executive Director’s process the new loan application until expenses with funds that belong to the proposal is consistent with the purpose it processes and deposits the loan payoff TSP participants. 5 U.S.C. 8437(c)(3), of the TSP, which is to grow retirement check, waits for it to clear, posts the 8437(d), and 8439(a)(3). TSP savings. funds to the participant’s account, and administrative expenses cost each Many commenters oppose limiting closes the loan. Given the enormous participant approximately .07 percent of participants to a single general purpose volume (900,000) of TSP loans that are his or her account balance each year. loan because they want to borrow from in existence, it is not administratively Although some participants asked the their TSP accounts to pay for medical reasonable to manually manage large Board to retain the policy of charging and dental expenses, home repair or numbers of pending loan applications the loan program’s expenses to all improvement, car repairs, or school until the outstanding loan is closed and participants, as explained above, the tuition. Other participants oppose the a new loan request can be processed. A Executive Director has determined that changes because they want to use TSP limited waiting period, clearly it is more equitable if the costs of the loans to pay off high interest credit communicated to participants and loan program are borne by the cards or as capital to start a business. equitably applied, provides a systematic participants who use the program. The loan program changes will not solution to this administrative problem.

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Several commenters questioned the withdrawal). However, proposed Dated: May 20, 2004. Board’s decision to advertise an § 1655.2(c) did not explain a second Gary A. Amelio, implementation date for the loan exception. Specifically, a participant Executive Director Federal Retirement Thrift program changes before receiving can apply for a loan if he or she is not Investment Board. comments on the proposed rule. Others eligible to make TSP contributions I For the reasons set forth in the asked the Board to delay because the participant stopped preamble, the Board amends 5 CFR implementation of the new rules. The contributing to the TSP and is not yet chapter VI as follows: Executive Director publicly announced eligible to resume contributing. Final the loan program changes in mid-2003 § 1655.2(c) explains this exception. PART 1650—METHODS OF for a mid-2004 implementation date; WITHDRAWING FUNDS FROM THE since then, he has made numerous The Executive Director is publishing THRIFT SAVINGS PLAN public statements about his intent to the proposed rule as a final rule with change the loan program. In addition, several other clarifying changes to I 1. The authority citation for part 1650 the Board announced the changes on the proposed sections 1655.21, 1690.12 and continues to read as follows: TSP Web site, the Thriftline, and in a 1690.13. Authority: 5 U.S.C. 8351, 8433, 8434, 8435, one-time written notice mailed to every 8474(b)(5), and 8474(c)(1). Regulatory Flexibility Act participant with an outstanding TSP Subpart G—Spousal Rights loan. Before publishing the proposed I certify that these regulations will not loan regulations in the Federal Register, have a significant economic impact on § 1650.61 [Amended] the Executive Director discussed the a substantial number of small entities. I 2. Amend § 1650.61 by removing changes in Congressional hearings, the They will affect only employees of the January 2004 TSP Highlights (a TSP ‘‘§ 1650.64’’ from paragraph (b) and Federal Government. publication), the April 2004 TSP ‘‘§ 1650.65’’ from paragraph (c)(1), and Highlights, numerous press interviews, Paperwork Reduction Act adding in their places ‘‘this subpart’’. and sought the advice of the Employee § 1650.62 [Amended] Thrift Advisory Council (ETAC). The I certify that these regulations do not ETAC is a 15-member body established require additional reporting under the I 3. Amend § 1650.62 by removing by FERSA to advise the Board on TSP criteria of the Paperwork Reduction Act ‘‘§ 1650.64’’ from paragraph (b) and matters. ETAC members represent of 1980. ‘‘§ 1650.65’’ from paragraph (c), and members of the Uniformed Services and adding in their places ‘‘this subpart’’. Unfunded Mandates Reform Act of Federal and postal employees, both § 1650.64 [Amended] active and retired, at all levels of 1995 government, from wage earners to senior I 4. Amend § 1650.64 by removing Pursuant to the Unfunded Mandates ‘‘§ 1650.64’’ from paragraph (a)(1) and executives. Reform Act of 1995, 2 U.S.C. 602, 632, The Board also welcomes the adding in its place ‘‘this subpart’’. 653, 1501–1571, the effects of this opportunity to review and respond to PART 1653—COURT ORDERS AND comments from participants who take regulation on State, local, and tribal an active interest in the TSP and wish governments and the private sector have LEGAL PROCESSES AFFECTING to offer suggestions. Some participants been assessed. This regulation will not THRIFT SAVINGS PLAN ACCOUNTS compel the expenditure in any one year who read the Highlights or news reports I of $100 million or more by State, local, 5. The authority citation for part 1653 wrote letters to the Agency and the is revised to read as follows: Agency fully considered their and tribal governments, in the aggregate, comments. Additionally, the Executive or by the private sector. Therefore, a Authority: 5 U.S.C. 8435, 8436(b), 8437(e), Director formally solicited comments statement under § 1532 is not required. 8439(a)(3), 8467, 8474(b)(5) and 8474(c)(1). from participants when he published Submission to Congress and the Subpart A—Retirement Benefits Court the proposed loan regulations. The Orders comment process allows the Board to General Accounting Office address any misunderstandings about Pursuant to 5 U.S.C. 810(a)(1)(A), the I 6. Amend section 1653.2 by revising the proposed loan changes, to learn if Board submitted a report containing this paragraph (a)(4) to read as follows: there are unanticipated legal or policy rule and other required information to impediments to the proposed changes, § 1653.2 Qualifying retirement benefits the U.S. Senate, the U.S. House of and to hear suggestions about how court orders. Representatives, and the Comptroller better to implement the proposed (a) * * * changes. Although the comments General of the United States before (4) A court order can require a received did not cause the Executive publication of this rule in the Federal payment only to a spouse, former Director to make any changes to the Register. This rule is not a major rule as spouse, child or dependent of a proposed loan rules, he did carefully defined at 5 U.S.C. 814(2). participant. consider all comments received. List of Subjects * * * * * Section 1655.2 I 7. Amend section 1653.3 by revising 5 CFR Parts 1650, 1653 and 1690 the last sentence of paragraph (b) Proposed § 1655.2(c) explains the introductory text to read as follows: general rule that a participant must be Employee benefit plans, Government eligible to contribute to the TSP before employees, Pensions, Retirement. § 1653.3 Processing retirement benefits court orders. he or she can apply for a TSP loan. It 5 CFR Part 1655 also explains an exception to that rule * * * * * (a participant can apply for a loan if his Employee benefit plans, Government (b) * * * To be complete, a court or her TSP contributions were employees, Military personnel, order must be written in English or be suspended when he or she obtained a Pensions, Retirement. accompanied by a certified English financial hardship in-service translation and contain all pages and

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attachments; it must also provide (or be Authority: 5 U.S.C. 8474. court order appointing an agent if the accompanied by a document that following conditions are met: I 14. Revise section 1690.12 to read as provides): (1) A court of competent jurisdiction follows: * * * * * (as defined at 5 CFR 1690.1) must have § 1690.12 Power of attorney. issued the court order; (2) The court order must give the PART 1655—LOAN PROGRAM (a) A participant or beneficiary can agent either general or specific powers, appoint an agent to conduct business I 8. The authority citation for part 1655 as explained in paragraphs (b) and (c) of with the TSP on his or her behalf by is revised to read as follows: this section; using a power of attorney (POA). The (3) The agent must satisfy the TSP Authority: 5 U.S.C. 8433(g), 8439(a)(3) and agent is called an attorney-in-fact. The 8474. that he or she meets any precondition TSP must approve a POA before the specified in the court order, such as a I 9. Revise section 1655.2 to read as agent can conduct business with the bonding requirement; follows: TSP; however, the TSP will accept a (4) The court order must be submitted document that was signed by the agent § 1655.2 Eligibility for loans. to the TSP record keeper for approval. before the TSP approved the POA. The (b) General grant of authority. A A participant can apply for a TSP TSP will approve a POA if it meets the general purpose or residential loan if: general grant of authority gives a following conditions: guardian or conservator unlimited (a) More than 60 calendar days have (1) The POA must give the agent elapsed since the participant has repaid authority to conduct business with the either general or specific powers, as TSP, including the authority to sign any in full a TSP loan of the same type. explained in paragraphs (b) and (c) of (b) The participant is in pay status; TSP-related document. By way of this section; example, an order gives a general grant (c) The participant is eligible to (2) A notary public or other official contribute to the TSP (or would be authority by appointing a ‘‘guardian of authorized by law to administer oaths or the ward’s estate,’’ by permitting a eligible to contribute but for the affirmations must authenticate, attest, suspension of the participant’s guardian to ‘‘conduct business acknowledge, or certify the participant’s transactions’’ for the ward, or by contributions because he or she or beneficiary’s signature on the POA; obtained a financial hardship in-service authorizing a guardian to care for the and ward’s ‘‘personal property’’ or ‘‘Federal withdrawal or because he or she (3) The POA must be submitted to the stopped contributing to the TSP and is Government retirement benefits.’’ TSP recordkeeper for approval. (c) Specific grant of authority. A not yet eligible to resume contributing); (b) General power of attorney. A (d) The participant has at least $1,000 specific grant of authority gives a general POA gives an agent unlimited in employee contributions and guardian or conservator authority to authority to conduct business with the attributable earnings in his or her conduct specific TSP transactions. Such TSP, including the authority to sign any account; and an order must expressly describe the TSP-related document. By way of (e) The participant has not had a TSP authority it grants. By way of example, example, a POA grants such authority loan declared a taxable distribution an order may authorize an agent to by authorizing the agent to act on behalf within the last 12 months for any reason ‘‘obtain information about the ward’s of the participant or beneficiary with other than a separation from TSP account’’ or ‘‘borrow or withdraw respect to ‘‘all matters,’’ ‘‘personal Government service. funds from the ward’s TSP account.’’ property,’’ ‘‘Federal Government I [FR Doc. 04–11844 Filed 5–25–04; 8:45 am] 10. Amend section 1655.4 by revising retirement benefits,’’ or ‘‘business BILLING CODE 6760–01–P the second sentence to read as follows: transactions.’’ § 1655.4 Number of loans. (c) Specific power of attorney. A specific power of attorney gives an agent * * * One of the two outstanding FARM CREDIT ADMINISTRATION loans may be a residential loan and the the authority to conduct specific TSP other one may be a general purpose transactions. A specific POA must 12 CFR Parts 614 and 615 loan. * * * expressly describe the authority it grants. By way of example, a specific RIN 3052–AB96 I 11. Revise paragraph (b) of section POA may authorize an agent to ‘‘obtain 1655.11 to read as follows: Loan Policies and Operations; Funding information about my TSP account’’ or and Fiscal Affairs, Loan Policies and § 1655.11 Loan acceptance. ‘‘borrow or withdraw funds from my Operations, and Funding Operations; TSP account.’’ * * * * * OFI Lending (b) The participant has the maximum I 15. Revise section 1690.13 to read as number of loans outstanding under follows: AGENCY: Farm Credit Administration. § 1655.4; ACTION: Final rule. § 1690.13 Guardianship and * * * * * conservatorship orders. SUMMARY: The Farm Credit I 12. Add a new section 1655.21 to read (a) A court order can authorize an Administration (FCA, agency, or we) as follows: agent to conduct business with the TSP adopts a final rule that amends § 1655.21 Loan fee. on behalf of an incapacitated participant regulations governing other financing or beneficiary. The agent is called a institutions (OFIs). The purpose of the The TSP will charge a participant a guardian or conservator and the final rule is to make it easier for OFIs $50.00 loan fee when it disburses the incapacitated person is called a ward. to obtain funding for short- and loan and will deduct the fee from the The TSP must approve a court order intermediate-term loans to farmers, proceeds of the loan. before an agent can conduct business ranchers, aquatic producers, farm- PART 1690—THRIFT SAVINGS PLAN with the TSP; however, the TSP will related businesses, and rural accept a document that was signed by homeowners through Farm Credit I 13. The authority citation for Part 1690 the agent before the TSP approved the System (FCS, Farm Credit, or System) continues to read as follows: court order. The TSP will approve a banks. The FCA believes that these

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changes will make credit to agriculture strengthen the equitable treatment loans to agricultural and aquatic and other eligible borrowers in rural provisions in the existing regulations by producers, farm-related business, and America more affordable. The final rule requiring a Farm Credit bank, at the rural homeowners. Improving OFI removes unnecessary provisions in the request of an OFI or OFI applicant; to: access to the funding and discount existing OFI regulations that: Impede (1) Disclose how it prices funds for services of Farm Credit banks could the flow of credit; or do not enhance OFIs; and (2) justify any discrepancy in make affordable credit more available to safe and sound operations. The FCA the cost of funding between OFIs and farmers, ranchers, and other eligible also adopts conforming amendments to associations. Another feature of the borrowers. Farm Credit banks fulfill its capital regulations. proposed rule is that it would allow their missions as a Government- DATES: Effective Date: This regulation Farm Credit banks to disclose the sponsored enterprise by enhancing the will be effective 30 days after identity of OFIs with their consent. The liquidity of OFIs, thereby lowering the publication in the Federal Register preamble to the proposed OFI rule cost of funding agriculture. during which time either or both Houses clarified the FCA’s position on borrower The FCA now addresses concerns and of Congress are in session. We will rights, and it offered suggestions for suggestions that the commenters raised publish a notice of the effective date in improving relationships between OFIs about various issues of the proposed the Federal Register. and the System, and the role of the FCA OFI rule. Ombudsman. The FCA also proposed FOR FURTHER INFORMATION CONTACT: A. Assured Access (§ 615.4540(b)(1)) changes to the Farmers’ Notes regulation Dennis K. Carpenter, Senior Policy and conforming amendments to its Section 1.7(b)(4)(B)(i) of the Farm Analyst, Office of Policy and capital regulations regarding risk Credit Act of 1971, as amended (Act) Analysis, Farm Credit Administration, weighting for OFIs and Farmers’ Notes. requires FCA regulations to assure that McLean, VA 22102–5090, (703) 883– The FCA received 111 comment the funding and discount services of 4498, TTY (703) 883–4434; or letters on the proposed rule. A total of Farm Credit banks are available on a Richard A. Katz, Senior Attorney, Office 8 comment letters came from the reasonable basis to any OFI that is of General Counsel, Farm Credit System; 1 from the Farm Credit Council significantly involved in lending for Administration, McLean, VA 22102– (FCC), 5 from Farm Credit banks, and 2 agricultural and aquatic purposes. 5090, (703) 883–4020, TTY (703) 883– from associations. Other commenters Currently, § 614.4540(b)(1) states that 2020. were an agricultural credit cooperative Farm Credit banks must ‘‘fund, SUPPLEMENTARY INFORMATION: OFI, a Community Development discount, or provide other similar financial assistance to any creditworthy I. Background Financial Institution (CDFI), the Credit Union National Association (CUNA), OFI that * * * maintains at least 15 This rulemaking began on April 20, which is a trade association for credit percent of its loan volume at a seasonal 2000, with an advance notice of unions, and two individuals. Finally, 98 peak in loans and leases to farmers, proposed rulemaking (ANPRM) that letters came from commercial bankers, ranchers, aquatic producers and asked all interested parties specific including the Independent Community harvesters.’’ Section 1.7(b) of the Act questions about the funding and Bankers of America (ICBA) and its state- and § 614.4540 of the regulations allow discount relationship between Farm affiliated associations. OFIs that do not meet this 15-percent Credit banks and OFIs.1 FCA staff The vast majority of the commenters threshold to fund and discount their subsequently conducted telephone and generally supported the proposed OFI short- and intermediate-term loans at field interviews with interested parties. rule, but both System and non-System Farm Credit banks, but they are not On August 3, 2001, we held a public commenters offered suggestions and assured access if credit becomes scarce. meeting in Des Moines, Iowa, where raised concerns about particular issues. During earlier phases of this interested parties offered suggestions on Commercial banks and their affiliated rulemaking, some commercial banks how we could facilitate greater trade associations opposed the proposed and System lenders expressed the cooperation between System and non- Farmers’ Notes rule. These commenters opinion that the 15-percent threshold System lenders in providing credit to asked the FCA to hold a public meeting, was too onerous, and they asked the agriculture and rural America. The seek additional public comment, and FCA to reduce or eliminate it. Some of public meeting addressed both the OFI solicit congressional input before these commenters mistakenly believed program and other arrangements where adopting a final Farmers’ Notes rule. that § 614.4540(b)(1) automatically the FCS and non-System lenders could Several FCS and non-System excluded non-System lenders from the help each other in extending credit to commenters asked the FCA to revise or OFI program if agricultural or aquatic farmers, ranchers, and other eligible clarify certain provisions in the loans did not compromise at least 15 borrowers in rural America. proposed capital risk-weighting percent of their loan portfolios. Many of the comments and regulations that applied to OFIs. Although the current regulation assures suggestions that we received from the We are enacting a final rule on OFIs, access to creditworthy OFIs that ANPRM, interviews, and at the public which includes conforming maintain at least 15 percent of their loan meeting were incorporated into the amendments to the capital regulations volume at a seasonal peak in proposed rule to revise both our OFI concerning the risk weighting of System agricultural loans, some commenters and the investment in farmers’ notes bank loans to OFIs. We are not adopting erroneously thought that it only (Farmers’ Notes) regulations.2 Basically, a final Farmers’ Notes rule at this time provided assured access to those OFIs the proposed OFI rule would allow OFIs because we are continuing to consider that always maintain at least 15 percent to establish a funding and discount the best regulatory approach to this of their loan portfolio in farm loans. The relationship with any one Farm Credit program. preamble to the proposed rule dispelled Bank (FCB) or agricultural credit bank both of these misconceptions.3 II. Final OFI Rule (ACB) (collectively Farm Credit banks). The FCA did not propose to change The proposed rule also would As explained earlier, the purpose of the 15-percent threshold as the factor this rule is to make it easier for OFIs to that determines whether an OFI is 1 See 65 FR 21151 (April 20, 2000). obtain funding from Farm Credit banks 2 See 68 FR 47502 (August 11, 2003). for their short- and intermediate-term 3 See 68 FR 47502, 47505 (August 11, 2003).

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assured access to funding from a Farm Farm Credit bank to consent to another too much flexibility to OFIs while Credit bank. The preamble to the System bank funding or discounting imposing unnecessary burdens on proposed rule explained that the loans for an OFI. System banks. One commenter thought standard that the FCA uses to determine The ANPRM, interviews, and public that the OFI should bear the burden of whether a non-System lender is meeting revealed widespread notifying the local Farm Credit bank substantially involved in agricultural dissatisfaction with the place of that it is taking its business elsewhere. lending is more permissive than the 25- discount rule in § 614.4550. Except for Two System commenters stated that the percent benchmark that the Federal one Farm Credit bank, all System and mere receipt of a credit application from Deposit Insurance Corporation non-System commenters favored an OFI located outside its chartered established for nonmember banks that it repealing all restrictions on place of territory does not mean that the Farm insures, and is comparable to the discount so OFIs could choose their Credit bank will approve funding. Since measure used by the Board of Governors System funding bank. The one Farm the FCS bank is unlikely to make a of the Federal Reserve System.4 The Credit bank that opposed repealing credit decision within 5 days, these FCA invited comments on alternatives § 615.4550 was concerned that FCS commenters stated that it should be that reasonably demonstrate that an OFI associations would be placed at a under no obligation to notify the Farm is significantly involved in agricultural competitive disadvantage. Credit bank that serves the territory lending because the agency is open to In response to these comments, the where the OFI is located. ideas that would make this program FCA proposed to revise § 615.4550 so System commenters and the more attractive to OFIs. OFIs could fund or discount loans with agricultural credit cooperative OFI The FCA received two comment any FCS bank. The FCA reasoned that opposed the ban on two or more Farm letters about assured access. Both letters this approach would free Farm Credit Credit banks simultaneously funding came from FCS institutions that support banks from potential pressure by the same OFI. Many of these the 15-percent threshold as the associations not to lend to their commenters stated that our safety and appropriate standard for determining competitors. Another factor that soundness rationale was unpersuasive. whether an OFI is significantly involved supports the proposed rule is that when These commenters note that many OFIs in agricultural lending. Farm Credit banks compete for OFI already have multiple sources of The final rule retains the 15-percent credit, the OFI may be able to obtain a funding, and that multilender financing threshold in existing § 614.4540(b)(1). more favorable funding cost, which it of commercial borrowers is The 15-percent threshold strikes a fair can then pass on to farmers and commonplace today in credit markets. balance between the needs of small ranchers.5 All of these commenters suggest that rural lenders and larger institutions. The proposed rule would require a intercreditor agreements among Agricultural loans usually comprise a Farm Credit bank to notify another different Farm Credit banks will larger percentage of the loan assets of System bank in writing within 5 adequately resolve the FCA’s safety and small rural lenders. However, larger business days of receiving an soundness concerns about disputes over institutions may extend more overall application from an OFI that maintains collateral if the OFI fails. credit, in dollar terms, to farmers, its headquarters or has more than 50 The FCA adopts final § 614.4550, although agricultural loans are a much percent of its loan volume in the which enables creditworthy OFIs to smaller percentage of their loan territory of the other Farm Credit bank. seek and establish a funding and portfolios. The purpose of this notice requirement discount relationship with the Farm is to give the bank in whose territory the Credit bank of their choice. Allowing B. Place of Discount (§ 614.4550) OFI is located ample opportunity to OFIs to choose their System funding Non-System lenders and many Farm contact the applicant and offer it bank frees them from the problems Credit banks have long considered place funding and discount services. The associated with obtaining credit from of discount restrictions as a major proposed rule would not allow any OFI banks that are owned and controlled by reason why the OFI program has not to borrow from two or more Farm Credit their competitors. This approach may been widely used by commercial banks banks at the same time. The preamble to lower the funding costs and improve the and other agricultural lenders. the proposed rule justified this ban on liquidity of OFIs which could, in turn, Historically, OFIs borrowed from the safety and soundness grounds. reduce the cost of credit to farmers, Farm Credit bank that serves the The FCA received 100 comments ranchers, and other eligible rural territory where the OFIs maintain their about place of discount. Of this total, 92 residents. headquarters or makes most of their came from commercial banks or their In response to System commenters, loans. As a result, OFIs have maintained trade associations, 6 from System banks the FCA does not view the 5-day notice a funding or discount relationship with and associations, and 1 each from requirement as a burden on Farm Credit a System bank that is owned and CUNA and the agricultural credit banks. This notice requirement ensures controlled by their competitors. cooperative OFI. All commercial bank that Farm Credit banks communicate In 1998, the FCA sought to remedy commenters and CUNA supported the with each other in providing funding this problem by adopting current FCA’s position on place of discount. and liquidity to OFIs. Additionally, this § 614.4550, which established new None of these commenters sought any regulatory requirement enables each place of discount rules for OFIs. Under revision to proposed § 614.4550. System Farm Credit bank to consider offering this regulation, every OFI must apply commenters agreed that an OFI should funding and discount services to OFIs in first to the Farm Credit bank that serves be allowed to fund or discount short-or its chartered territory. The 5-day notice the territory where the OFI operates. If intermediate-term loans with the Farm requirement has no relationship to the the Farm Credit bank denies funding, or Credit bank of its choice. credit approval process at a Farm Credit otherwise fails to approve a completed However, System commenters bank that receives an application from application within 60 days, the OFI may opposed the 5-day notice requirement in an OFI outside its territory. Written apply to any other Farm Credit bank. the proposed rule. These commenters notice is required within 5 days, Additionally, the regulation allows a claim that the notice requirement grants regardless of whether the Farm Credit bank has considered or acted upon an 4 Ibid. 5 Ibid. application received from such OFIs.

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Simply providing written notice to rights on those loans that Farm Credit that the OFI has removed from collateral another Farm Credit bank within 5 days banks fund or discount. at its System funding bank. Under the is neither costly nor difficult to any During all phases of this rulemaking, bank’s suggested interpretation of the System bank that receives applications System and commercial bank statute, section 4.13A of the Act would from OFIs outside its chartered territory. commenters have repeatedly advised be the only borrower rights provision of The FCA retains the ban on two or the FCA that borrower rights are an the Act that would always apply to OFI more Farm Credit banks simultaneously impediment to the success of the OFI borrowers. This provision enables funding the same OFI. Although System program. However, many commenters System and OFI borrowers to obtain arguments against this ban have some acknowledged that the Act requires copies of: (1) All loan documents they merit, policy concerns justify the FCA’s OFIs to comply with borrower rights sign or deliver; (2) loan appraisals on decision to retain it. In retail credit requirements. The FCA cannot repeal their assets that the lender uses in markets, financing by multiple lenders § 614.4560(d) because it implements making credit decisions; and (3) the of the same borrower and intercreditor statutory borrower rights requirements. lender’s articles of incorporation and agreements are commonplace. However, The FCA proposed a technical bylaws. discount banks established by Congress correction to § 614.4560(d) that would The proposed rule retained the to fulfill a public policy mission remove the reference to section 4.36 of provision in § 614.4560(d), which states generally do not engage in such the Act from the regulation because the that borrower rights apply to all loans practices. For example, two Federal plain language of the statute grants the that an OFI funds or discounts through Reserve Banks or two Federal Home right of first refusal only to borrowers of a Farm Credit bank. The preamble to the Loan Banks do not simultaneously fund FCS institutions that operate under proposed rule thoroughly examined and the same member bank. Generally, each titles I or II of the Act, not OFIs. One analyzed the text, structure, and System commenter agreed with the FCS association receives all of its legislative history of the borrower rights technical correction to § 614.4560(d), funding from one Farm Credit bank. In provisions of the Act, and it explained while all other commenters expressed addition, an association cannot seek in detail why borrower rights apply to no opinion about this matter. The final credit from another System bank unless all loans that OFIs fund through a Farm rule removes the reference to section its funding bank consents. Therefore, Credit bank. The discussion in the 4.36 of the Act from § 614.4560(d) so the ban on two or more Farm Credit preamble to the proposed rule revealed that the regulation conforms to the banks simultaneously funding the same that Congress intended to grant OFI statute. OFI is consistent with the FCA’s policy borrowers whose loans are funded by a The FCA recently moved all borrower Farm Credit bank all of these rights and of requiring FCS banks to treat their rights regulations to part 617.6 For this protections, even at times when their OFIs and System associations equitably. reason, the FCA revises all of the cross- loans are not actually pledged as The agricultural credit cooperative references in final § 614.4560(d) to the collateral to the System funding bank. OFI expressed concern about how the borrower rights regulations to reflect Except for one association, which ban on two FCS banks simultaneously this change. expressed no opinion on this matter, all funding the same OFI would affect its Currently, § 614.4560(d) states that other System commenters opposed the business. The commenter stated that its borrower rights apply to ‘‘all loans that FCA’s interpretation of the borrower parent is an agricultural cooperative that an OFI funds or discounts through a rights provision of the Act. These borrows from the ACB under title III of Farm Credit Bank or agricultural credit commenters stated that this approach the Act, while it is an OFI that borrows bank * * *’’ (Emphasis added). Earlier, conflicts with the FCA’s stated goal of from a Farm Credit bank and sells a Farm Credit bank pointed out that making the OFI program more attractive participations in loans to FCS section 4.14A(a)(6)(B) of the Act to potential and existing OFIs. Some associations. The FCA clarifies that requires an OFI to comply with commenters stated that the FCA’s nothing in the proposed or final borrower rights, ‘‘but only with respect position was impractical because regulation prevents: (1) OFIs from to loans discounted or pledged under neither the agency nor the funding bank participating in loans with System section 1.7(b)(1).’’ As a result, this can enforce compliance with borrower associations; or (2) any parent or System bank asserted that the language rights after an OFI has removed a affiliate which is an agricultural in § 614.4560(d) exceeds the scope of distressed loan from collateral. cooperative from borrowing from the section 4.14A(a)(6) of the Act. None of these commenters offered ACB under title III of the Act. Specifically, the Farm Credit bank new information or provided any legal C. Borrower Rights (§ 614.4560(d)) interpreted section 4.14A(a)(6) of the analysis that would cause the FCA to Act to mean that borrower rights apply change its interpretation of section Section 4.14A(a)(6)(B) of the Act to OFI loans only during the time that 4.14A(a)(6) of the Act. Accordingly, the expressly requires OFIs to adhere to they are actually pledged to the funding FCA reaffirms its interpretation of borrower rights, ‘‘but only with respect bank as collateral. Under this section 4.14A(a)(6) that it presented in to loans discounted or pledged under interpretation, most borrower rights the preamble to the proposed rule. section 1.7(b)(1).’’ The borrower rights would not apply to OFI loans because Under section 4.14A(a)(6) of the Act, that apply to loans that OFIs discount or many of these rights apply before or borrower rights apply to all loans that pledge with a Farm Credit bank are: (1) after the time that these loans are an OFI funds or discounts through a Effective Interest Rate (EIR) disclosures; actually pledged to the System funding Farm Credit bank. The borrower (2) notice of adverse credit decision; (3) bank. Examples of borrower rights that continues to be entitled to borrower the right to appeal adverse credit would not apply to OFI loans under this rights after the OFI removes the loan decisions to the lender’s credit review interpretation are: (1) Most EIR from collateral. Only a statutory committee; (4) receiving copies of disclosures; (2) the right to appeal amendment could resolve the concerns certain documents; and (5) the right to certain adverse credit decisions to an raised by the commenters. restructure distressed loans. An existing OFI’s credit review committee; and (3) The ICBA and its member banks regulation, § 614.4560(d), implements the right to restructure a distressed loan stated that depository institutions section 4.14A(a)(6)(B) of the Act by should not have to comply with requiring OFIs to comply with borrower 6 See 69 FR 10901 (March 9, 2004). borrower rights because they must

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comply with the Community According to these commenters, this fundamental differences that distinguish Reinvestment Act (CRA). These perception of unfair treatment deters FCS associations from OFIs. The FCA commenters asked the FCA to treat many agricultural lenders from reasoned that these fundamental compliance with the CRA as a substitute becoming OFIs, while existing OFIs feel differences preclude § 614.4590 from to compliance with borrower rights that FCS associations always receive mandating equal treatment for requirements. preferential treatment from System associations and OFIs. The preamble to The FCA responds that the Act funding banks. the proposed rule also explained that explicitly requires OFIs to comply with Commercial bank commenters these fundamental differences mean that borrower rights on all loans that they suggested that our regulations could OFIs expose Farm Credit banks to fund or discount through a Farm Credit rectify this problem by mandating equal, different credit risks and administrative bank, regardless of whether they are also rather than equitable, treatment of OFIs costs than direct lender associations. As subject to the CRA. The purposes, and FCS associations. Because these a result, some disparity in cost of funds objectives, and compliance mechanism commenters stated that this disparity of that an FCB or ACB charges FCS of the CRA are separate, distinct, and treatment was especially evident in the associations and OFIs may be justified. independent from the borrower rights price of funding that Farm Credit banks The proposed rule did not require Farm requirements of the Act. The CRA does charge their associations and OFIs, they Credit banks to pay dividends or not provide farmers, ranchers, and asked the FCA to amend § 614.4590 so patronage to their OFIs because the FCA aquatic producers and harvesters the it requires Farm Credit banks to disclose found it inappropriate to impose, by rights and protections on agricultural to OFIs exactly how they price their regulation, business practices on FCS loans that the Act confers on them. loans to both OFIs and FCS associations. institutions in the absence of a Neither the Act nor the CRA authorizes These commenters also stated that the compelling safety and soundness depository institutions to substitute FCA should require Farm Credit banks reason.7 CRA requirements for compliance with to identify the specific components that In response to the proposed rule, the borrower rights. For this reason, the make up their cost of funds to OFIs and FCA received comment letters on FCA has no authority to grant this the amount of these components in equitable treatment from the FCC, a request. terms of basis points. Another Farm Credit bank, an agricultural credit One Farm Credit bank asked the FCA suggestion was that § 614.4590 should cooperative OFI, the ICBA and several to clarify that borrower rights do not be revised so it expressly prohibits Farm of its commercial bank members. The apply to loans that an OFI pledges as Credit banks from charging OFIs fees two System commenters believe that the supplemental collateral. Under that are not charged to FCS associations. new disclosure requirements in § 614.4570(c), Farm Credit banks may Some commercial banks commented proposed § 614.4590 impose costs and require an OFI to pledge supplemental that the regulation should require Farm burdens on FCS banks that outweigh the collateral or provide other credit Credit banks to pay dividends or benefits to OFIs. The Farm Credit bank enhancements that support the lending patronage to OFIs. stated that the revisions to § 614.4590 relationship. Farm Credit banks take In response to these comments, the ‘‘are heavily slanted in favor of the supplemental collateral from their OFIs FCA proposed adding two new OFIs.’’ Both System commenters out of an abundance of caution. provisions to § 614.4590. Proposed expressed concern that § 614.4590 However, Farm Credit banks do not § 614.4590(c) would require each FCB or would require Farm Credit banks to fund or discount supplemental ACB to provide any OFI or OFI disclose ‘‘proprietary pricing collateral pledged by their OFIs. For this applicant, upon request, a copy of its procedures’’ and information to OFIs, reason, borrower rights would not apply policies, procedures, loan underwriting which could now establish a funding or to agricultural loans that OFIs pledge to standards, and pricing guidelines for discount relationship with any System their System funding bank as OFIs. This provision would also require bank under § 614.4550. Although supplemental collateral. that the pricing guidelines must identify commercial bank commenters support the specific components that make up the new disclosure requirements in D. Equitable Treatment (§ 614.4590) the cost of funds for OFIs and the § 614.4590, they continue to state that An FCA regulation, § 614.4590, amount of these components in basis this regulation should require equal, requires Farm Credit banks to treat OFIs points. Proposed § 614.4590(d) would rather than equitable, treatment of and FCS associations equitably. More require each FCB or ACB to explain in associations and OFIs. specifically, § 614.4590(a) requires that writing the reasons for any variation in The commercial bank commenters Farm Credit banks apply comparable the overall funding costs it charges OFIs urged the FCA to enact a final rule that and objective loan underwriting and FCS associations if such requires the equal funding costs for FCS standards and pricing requirements to information is requested by an OFI or associations and OFIs because in their both OFIs and FCS associations. Under OFI applicant. This provision would view, System institutions ‘‘have easy § 614.4590(b), the total charges that a require a Farm Credit bank to compare access to all the credit they need’’ while System bank assesses its OFIs must be the costs that it charges OFIs and FCS OFIs must rely on several funding comparable to the total charges it associations as groups or, if possible, sources, each which is limited. imposes on its affiliated associations. variations between groups of OFIs and Commercial banks and the agricultural Section 614.4590(b) additionally FCS associations that are of a similar credit cooperative OFI asked the FCA to requires that any variation between the size. However, proposed § 614.4590(d) require FCS banks to: (1) Earmark the overall funding costs that OFIs and FCS would expressly prohibit System capital contribution of each OFI, and (2) associations are charged by the same funding banks from disclosing financial pay patronage and dividends to OFIs funding bank must result from or confidential information about whenever FCS associations receive such differences in credit risk and individual FCS associations. payments. administrative costs to the FCB or ACB. The FCA declined requests to amend After considering these comments, the Many respondents to the ANPRM and § 614.4590 so it would require equal, FCA has decided to enact proposed speakers at the public meeting told the instead of equitable, treatment of FCS § 614.4590 as a final rule without FCA that Farm Credit banks continue to associations and OFIs. The preamble to favor FCS associations over OFIs. the proposed rule listed five 7 See 68 FR 47502, 47505 (August 11, 2003).

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revision. The final rule appropriately to determine whether Farm Credit banks The FCA would oppose any attempt balances the interests of Farm Credit are pricing OFI credit equitably. by System banks to encumber their OFIs banks, OFIs, and System associations. with the entire cost of the Office of the E. Ombudsman In response to System concerns, the Ombudsman. Such attempts would FCA believes that OFI program will Many commercial banks and their violate the requirement in § 614.4590 become more transparent because final trade associations asked us in their that Farm Credit banks treat their § 614.4590(c) and (d) now require Farm response to the ANPRM and during the associations and OFIs equitably. Credit banks to disclose pricing public meeting to appoint an F. Disclosure of OFI Identities information to their OFIs. Transparency Ombudsman to assist OFI applicants (§ 614.4595) enables both OFIs and FCA examiners and existing OFIs in establishing and to objectively determine whether a Farm maintaining good relations with System The ANPRM asked the public Credit bank is treating its associations funding banks. On February 25, 2003, whether FCA regulations should allow and OFIs equitably. Allowing OFIs to the FCA Board established the Office of Farm Credit banks to disclose the choose their System funding bank while the Ombudsman. The public identities of the OFIs that they fund. simultaneously requiring Farm Credit announcement, which informed the Current FCA regulations prohibit FCS banks to disclose pricing information to public of the creation of this office institutions from releasing information OFIs achieves the FCA’s objective of stated, ‘‘The Office of the Ombudsman about their retail borrowers and making this program more attractive to will be an effective, neutral and stockholders to the public.9 However, existing and potential OFIs. Disclosing confidential resource and liaison for the the FCA never interpreted these pricing information helps OFIs make public.’’ One of many duties of the regulations as prohibiting the release of informed decisions in selecting their Ombudsman is to address the concerns names of FCS associations that borrow 10 System funding bank. As a result, the of OFIs and facilitate better from Farm Credit banks. The OFI can pass these pricing advantages relationships between them and the preambles to both the ANPRM and the along to farmers, ranchers, and other FCS. The FCA repeated this information proposed rule explained why the FCA eligible borrowers. Funding and in the preamble to the proposed rule.8 believes that the reasons for protecting discounting loans for OFIs is part of the The FCC and a System bank stated in the identity of retail borrowers do not public policy mission of System banks, their comment letters that the sole task apply to financial institutions that fund which are cooperative institutions that and discount loans with a Farm Credit of the Ombudsman is to serve as an 11 are jointly and severally liable for FCS advocate for OFIs. Since System banks bank. As both preambles explained, retail borrowers often are individual debt. Accordingly, the FCA is not pay for the Office of the Ombudsman consumers, and keeping their identities persuaded by the commenters’ through assessments that the FCA levies confidential shields them from arguments that the regulation gives OFIs on them, these commenters suggest that unwanted marketing solicitations or access to ‘‘proprietary’’ pricing it would be appropriate for these banks publicity involving their personal information at several different Farm to pass the cost along to their OFIs. One financial business whereas OFIs could Credit banks. commenter stated that the FCA has no Commercial bank commenters offered benefit from the disclosure of their express statutory authority to establish no new information or analysis that identity because it could make the Ombudsman position. would persuade the FCA to amend this prospective retail borrowers aware of regulation so it requires equal, rather The FCA repeats what it said in the other credit options. than equitable, treatment of OFIs and public announcement and the preamble In response to ANPRM comments and FCS associations. In fact, the most to the proposed regulation. The FCA testimony in the public meeting, the recent comments from commercial emphasizes that the Office of the FCA proposed a new regulation, banks reinforce the notion that OFIs are Ombudsman is an effective, neutral and § 614.4595 which would allow Farm fundamentally different than FCS confidential resource and liaison for the Credit banks to disclose to the public associations. Thus, OFIs pose different public. Addressing the concerns of OFIs the names, addresses, telephone credit risks to System banks than is only one of the Ombudsman’s duties. numbers, and Internet Web site associations which, in turn, could Several provisions of title V of the Act addresses of those OFIs that consent in justify the differential in the cost of grant the FCA power to establish the writing. The proposed regulation also funding charged to the two groups of Office of the Ombudsman. Section 5.9 of would require each Farm Credit bank to lenders. the Act enables our Board to ‘‘provide adopt policies and procedures for: (1) The FCA declines the request that the for the performance of all the powers Obtaining and maintaining the consent final rule require FCS banks to: (1) and duties vested in the Farm Credit of its OFIs; and (2) disclosing this Allocate the capital contribution of each Administration.’’ Section 5.11(b) of the information to the public. Financial OFI; and (2) pay patronage and Act empowers the Chairman of the FCA statements of Farm Credit banks should dividends to OFIs when FCS to ‘‘appoint such personnel as may be not disclose the identity of an OFI associations receive similar payments. necessary to carry out the functions of unless it consents. The FCA believes System banks distribute patronage and the Farm Credit Administration.’’ This that this regulatory approach empowers dividends to their shareholders in section of the Act also states, ‘‘The each OFI to make the decision whether accordance with their bylaws. FCA appointment by the Chairman of the disclosure of its name, address, regulations do not prescribe business heads of major administrative divisions telephone number, and Internet Web practices at System institutions in the under the Board shall be subject to the site address to the public is in its best absence of compelling safety and approval of the Board.’’ The FCA Board interest. soundness reasons. However, each voted to establish this office in order to System bank must factor in capital address concerns by members of the 9 12 CFR part 618, subpart G. contributions as well as patronage and public about how the agency or the 10 In fact, information about the identities of FCS dividend payments when it prices credit System is carrying out their associations is widely available because it is contained in financial statements that Farm Credit for an OFI. The new regulatory responsibilities under the Act. banks release to the public. disclosure requirements make it easier 11 See 65 21151, 21154 (April 20, 2000); 68 FR for the OFIs and other interested parties 8 Ibid. 47502, 47508 (August 11, 2003).

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The FCA received comments about ICBA’s ‘‘opt-out’’ approach. Under the G. Associations Acting as Farm Credit this issue from the FCC, two Farm approach in § 615.4595, the OFI decides Bank Agents Credit banks, the ICBA, and CUNA. The whether to allow its System funding Both System and non-System FCC and a System bank see no need for bank to disclose its identity to the commenters suggested in their this regulation because they believe that public, and then it communicates its the regulations in subpart G of part 618, responses to the ANPRM and during decision to the bank, which honors its testimony at the public meeting that which govern the release of information decision. In contrast, disclosure occurs about System borrowers and FCS associations could serve as an under the ‘‘opt-out’’ approach unless the effective conduit for funding OFIs. shareholders, already permits Farm OFI takes action to stop it by a certain Credit banks to disclose the identity of These commenters pointed out that deadline. an OFI that consents. If the FCA adopts associations often have established a final disclosure regulation for OFIs, Under final § 614.4595, a Farm Credit relationships with local OFIs and other two System banks suggest preamble Bank or agricultural credit bank may commercial lenders. In many cases, FCS clarifications and minor edits to the text disclose to members of the public the associations and existing and potential of § 614.4595. The CUNA supports name, address, telephone number, and OFIs already have entered into joint proposed § 614.4595 because it believes Internet Web site address of any financing arrangements for common that disclosure of a credit union’s affiliated OFI only if such OFI, through borrowers. identity will help inform farmers, a duly authorized officer, consents in The FCA stated in the preamble to the ranchers, and other eligible borrowers writing. Each Farm Credit Bank and proposed rule that the Act allows only about their other credit options and the agricultural credit bank must adopt Farm Credit banks that operate under benefits of credit union membership. policies and procedures for requesting, title I of the Act, not FCS associations, The ICBA suggests the FCA switch from obtaining, and maintaining the consent to establish funding and discount an ‘‘opt-in’’ to an ‘‘opt-out’’ approach in of its OFIs and for disclosing this relationships with OFIs. However, the the final rule. Under an ‘‘opt-out’’ information to the public. preamble to the proposed rule pointed approach, each Farm Credit bank would out that section 1.5(18) of the Act allows automatically disclose an OFI’s identity The FCA inserted the word a Farm Credit bank to delegate to to the public unless the OFI instructed ‘‘requesting’’ into the final regulation associations such functions as the bank it, in writing, not to do so. The ICBA § 614.4595 in response to a comment deems appropriate while section 2.2(19) contends that an ‘‘opt-out’’ approach is from a Farm Credit bank. The allows a direct lender association to consistent with the trend in the law commenter suggested that the FCA perform functions delegated to it by its governing disclosure of customer change the word ‘‘obtaining’’ in the funding bank. Thus, sections 1.5(18) information by financial institutions. proposed regulation to ‘‘requesting.’’ and 2.2(19) of the Act enable FCS The FCA adopts § 614.4595 as a final According to the commenter, a System associations to act as point-of-contact or rule after slightly changing the text of bank should not be accountable for servicing agents for the Farm Credit the regulation in response to a comment ‘‘obtaining’’ consent from an OFI. The bank in its lending relationship with its from a System bank. The FCA disagrees commenter believes that ‘‘requesting’’ OFIs.12 with the two System commenters that the OFI’s consent is the most the System Allowing FCS associations to act as this regulation is unnecessary because funding bank can do. After considering intermediaries between Farm Credit the regulations in subpart G of part 618 this comment, the FCA amended the banks and OFIs may make this program already govern releases of information regulation so it requires System banks to more successful and reduce tensions about System borrowers and adopt policies and procedures for between the System and OFIs. In shareholders. As the preambles to the particular, designating associations as ANPRM and proposed rule explain, the ‘‘requesting, obtaining, and maintaining’’ the consent of its OFIs. intermediaries and servicing agents for regulations in subpart G of part 618 Farm Credit banks on their OFI loans apply only to releasing information This revision enhances the clarity and accuracy of the final regulation. A Farm may help diminish the competitive about retail borrowers. For this reason, rivalries that have historically troubled a new regulation is needed to clarify the Credit bank must request and obtain the the relationship between OFIs and authority of System banks to disclose OFI’s written consent before it can associations. Farmers and ranchers information about OFIs. publicly disclose the OFI’s identity. The FCA declines the ICBA’s request benefit when FCS associations and OFIs One Farm Credit bank asked the FCA work together. Agreements between the to revise § 615.5495 so that the final for assurances that § 614.4595 does not regulation requires System banks to parties can establish these arrangements restrict the System bank’s right to file and, therefore, no new regulation is disclose an OFI’s identity unless the OFI financing statements or other routine ‘‘opts-out.’’ The FCA believes that the necessary. public filings that protect its security ‘‘opt-in’’ approach in the proposed rule The FCA received 2 comment letters interest under applicable law. The FCA is easier for System banks to administer about this issue from a Farm Credit bank affirms that the final rule does not than the ‘‘opt-out’’ approach favored by and association. The Farm Credit bank the commenter. Requiring an OFI to hinder the right or ability of any System commenter concurred that existing affirmatively consent, in writing, to the bank to perfect its security lien in statutory authorities are sufficient to disclosure of its identity avoids the collateral pledged by its OFIs. This support associations acting as agents of misunderstandings and approach is similar to other Federal Farm Credit banks in their relationship miscommunications that are more likely laws that protect the privacy of with OFIs and, therefore, no regulation to occur if disclosure happens consumers who buy goods and services is necessary. The association fully automatically unless or until the OFI on credit. Although these laws restrict supported allowing associations to act takes action to stop it. Also, the FCA’s the release of confidential information as intermediaries for the Farm Credit ‘‘opt-in’’ approach gives OFIs more by the creditor, they do not prevent the banks in establishing and servicing OFI control and flexibility over the decision creditor from filing public documents relationships. to allow System funding banks to that enable it to collect the debt in event publicly disclose their identity than the of default. 12 See 68 FR 47502, 47508 (August 11, 2003).

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The FCA reaffirms that FCS urge the FCA to enact a regulation that agricultural mortgage loans that OFIs associations have no authority under the prevents Farm Credit banks from make to their customers. Act to lend directly to OFIs, but they imposing a lending limit that is more J. Improving the Relationship Between can act as intermediaries or servicing stringent than the limit established by Farm Credit Banks and OFIs agents on loans from a Farm Credit bank Federal or state law. to OFIs. The FCA reaffirms its earlier position In response to the ANPRM and during that each Farm Credit bank may the public meeting, several System and H. OFI Lending Limits establish, by underwriting standards non-System commenters offered various In 1998, the FCA repealed former and GFAs, limits on its exposure to suggestions for improving the § 614.4565, which imposed a lending concentrations in the loan portfolios of relationship between Farm Credit banks limit on the amount of credit that any FCS associations and OFIs that are more and prospective and existing OFIs. The OFI could extend to a single credit risk stringent than lending limits imposed commenters’ suggestions are with FCS funds. At the time, we by statute or regulation. However, confidence-building measures that acknowledged that certain OFIs would System banks would not be treating could attract more OFIs to establish remain subject to lending limits that OFIs equitably if they establish lending funding and discount relationships with their primary regulator imposes under limits that favor FCS associations over Farm Credit banks. These suggestions applicable Federal or state law. The OFIs. Additionally, any decision by a could help improve relations between preamble to the final rule stated that we Farm Credit bank to establish a lending existing OFIs and their funding banks expect each Farm Credit bank to limit that is more stringent than the and encourage prospective OFIs to prudently manage risk exposures to limit imposed on an OFI by applicable establish funding and discount concentrations in OFI loan portfolios Federal or state law, or its corporate relationships with Farm Credit banks. through underwriting standards and its parent must have a safety and The FCA conveyed these ideas to general financing agreement (GFA) with soundness justification. Commercial Farm Credit banks by publishing the each OFI.13 bank commenters have provided no new suggestions in the preamble to the After the FCA repealed former information or analysis that would proposed rule. These suggestions would § 614.4565, some Farm Credit banks persuade the FCA to prohibit Farm require Farm Credit banks to take the considered imposing a lending limit on Credit banks, by regulation, from initiative and reach out to existing and both FCS associations and OFIs that is imposing a lending limit on OFIs that is prospective OFIs. More specifically, the lower than the lending limit that: (1) more stringent than the limit established FCA encouraged Farm Credit banks to § 614.4353 establishes for System direct by law or the corporate parents of such consider developing internal programs lender associations; and (2) Federal or OFIs. The FCA declines this request. and initiatives that: state laws place on depository I. Eligible Collateral Pledged To Support 1. Establish outreach programs for institutions. During earlier phases of contacting prospective OFIs and this rulemaking, two non-System an OFI’s Discounting Arrangements With a Farm Credit Bank (§ 614.4570) providing them with information about commenters asked us to enact a new the banks’ services; regulation that would forbid Farm Currently, § 614.4570 requires a 2. Routinely publish updated Credit banks from imposing a lending secured lending relationship between information about their products and limit on OFIs that is lower than the limit each Farm Credit bank and every OFI. services for OFIs, and their established by applicable Federal or Under § 614.4570(b)(2), each FCB or underwriting standards, funding terms state law. The FCA declined this request ACB must perfect its security interest in and conditions, and pricing guidelines because it is inconsistent with safety any and all obligations and the proceeds for OFI loans; and soundness. The preamble to the thereunder that the OFI pledges as 3. Allow OFI representatives to proposed rule stated that each Farm collateral, in accordance with applicable observe meetings of the banks’ board of Credit bank may establish, by state law. Additionally, § 614.4570(c) directors; underwriting standards and the GFA, allows each FCB and ACB to require its 4. Promote better communication limits on its exposure to concentrations OFIs to pledge supplemental collateral through roundtable discussions, focus in the loan portfolios of both FCS to support the lending relationship. groups, and public discussions that associations and OFIs that are more A comment letter from a System bank bring OFIs, associations, and other stringent than lending limits imposed acknowledged that the Act prohibits interested parties together to discuss by statute or regulation, as long as it Farm Credit banks from: (1) Advancing issues of mutual interest; does not favor FCS associations over funds for long-term real estate mortgages 5. Work with OFIs to identify and OFIs.14 to OFIs; and (2) accepting mortgages as remove administrative barriers that The FCA received comments on this primary collateral from OFIs. The hinder OFI access; issue from a Farm Credit bank, the commenter opined that the statutory 6. Allow FCS associations to act as ICBA, and 95 commercial banks. The ban on System banks funding and intermediaries and servicing agents on Farm Credit bank supported the FCA’s discounting agricultural mortgages for extensions of credit from the funding position. The ICBA agreed with the FCA OFIs is a major impediment to bank to OFIs, as discussed earlier; and that lending limits imposed by FCS expansion of this program. The 7. Identify best practices for OFIs. banks on OFIs should be on the same commenter then asked the FCA to The FCA published these suggestions basis as for FCS associations. The ICBA develop regulatory interpretations that in the preamble to the proposed rule asserted that System banks should not would enable System banks to overcome because we are strongly committed to impose ‘‘unduly restrictive’’ lending this obstacle. the success of the OFI program. The limits on OFIs, and they should be As acknowledged by the commenter, FCA reasoned that by adopting the commensurate with limits set by the the Act does not authorize long-term internal programs and initiatives OFI’s parent or primary regulator. funding for OFIs. FCA regulations, described above, Farm Credit banks can Several commercial banks continued to policies, or interpretations must comply attract more OFIs which, in turn, will with the Act. Therefore, an amendment provide eligible farmers, ranchers, 13 See 63 FR 36541, 36545 (July 7, 1998). to the Act is necessary to authorize aquatic producers and harvesters, farm- 14 See 68 FR 47502, 47508 (August 11, 2003). Farm Credit banks to fund or discount related businesses, and rural

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homeowners with more plentiful and and existing OFIs; and (2) take the sources of funding. The CDFI Fund affordable credit, as Congress intended. initiative in building confidence provides financial and technical Another passage in the preamble to the between OFIs and the System. All of assistance in the form of grants, loans, proposed rule advised the public that these suggestions concentrated on ideas equity investments, and deposits to the FCA may provide additional for improving communications between competitively selected CDFIs. The guidance to Farm Credit banks about the System and non-System agricultural private sector also provides equity improving the OFI program through lenders that are, or may become OFIs. investments and credit to CDFIs. Some bookletters, informational memoranda, From time to time, the FCA and other CDFIs are depository institutions and, and the Office of the Ombudsman. The regulators offer guidance to institutions therefore, they obtain some funds for preamble to the proposed rule informed that they regulate. The suggestions are their operations from deposits as well as the public that new regulations may not not mandatory, but are guidelines, credit lines with other lenders. CDFIs be required to implement these which pertain to business practices work in partnership with other financial suggestions for improving the OFI instead of safety and soundness or institutions to channel credit and program.15 compliance with laws and regulations. investment into economically distressed The FCA received several comments System banks may consider other communities. about this guidance from both FCS and approaches that foster strong and There are six basic types of CDFIs. non-System commenters. Letters from healthy relationships with OFIs in Specific language in section 1.7(b)(1)(B) commercial banks strongly supported addition to, or instead of, the ideas that of the Act determines whether an entity the recommendations and urged the the FCA has suggested. If System banks is eligible to borrow from a Farm Credit FCA to encourage Farm Credit banks to invite OFI observers to their board bank as an OFI and would authorize undertake all of these initiatives so: (1) meetings, they should consider certain types of CDFIs as OFIs. Under Their relationships with OFIs would appropriate measures that protect the section 1.7(b)(1)(B) of the Act and improve; and (2) this program would confidentiality of information. The FCA § 614.4540 of FCA regulations, two become more attractive to non-System emphasizes the importance of System types of CDFIs, community agricultural lenders. In contrast, System banks reaching out to OFIs. development banks and community commenters stated that the FCA was development credit unions, could K. CDFIs interfering in the internal business become OFIs that fund, discount, or affairs of System banks without any A CDFI urged the FCA to amend the obtain other similar financial assistance safety or soundness justification. These OFI regulations so they facilitate System from a Farm Credit bank in order to commenters found it unusual for the bank lending to CDFIs that primarily extend short- and intermediate-term preamble to encourage certain practices serve young, beginning, small, and low credit to eligible borrowers for at System banks while acknowledging resource farmers and ranchers. The authorized purposes pursuant to that new regulations are unnecessary. commenter made no specific regulatory sections 1.10(b) and 2.4(a) and (b) of the Four System commenters objected to recommendations to the FCA with Act. Since the mission of CDFIs is to the suggestion that Farm Credit banks regard to CDFIs being designated as serve economically distressed segments invite OFI observers to their board OFIs. The commenter did suggest a of the population, those CDFIs that meetings. According to these regulatory change to treat CDFIs as the become OFIs may use funding, discount commenters, matters discussed at bank equivalent of Organization for Economic services, and other financial assistance board meetings are confidential and Cooperation and Development (OECD) from a Farm Credit bank to serve young, only board members and officers attend banks 16 for risk-weighting purposes. We beginning, small, and low resource such meetings. One System commenter address this comment later under farmers and ranchers. In addition, the objected to the suggestion that Farm section III. Capital Risk Weighting of FCA encourages Farm Credit banks to Credit banks identify best management this preamble. work with eligible CDFIs that make practices for OFIs. From this CDFIs are private sector financial loans or extend other similar financial commenter’s perspective, OFIs are intermediaries that offer financial assistance to agriculture and are independent financial institutions that services to economically distressed interested in establishing an OFI are responsible for their own operation, communities. These institutions provide relationship. Because of eligibility and Farm Credit banks should not economically distressed communities restrictions in the Act for OFI funding, attempt to impose their own views with credit, capital, and financial no other amendments to the regulations about best management practices on services that often are unavailable from are allowable. their OFIs. This commenter expressed other financial institutions. The Section 4.19(a) of the Act mandates concern that System banks could be Community Development Financial that Farm Credit banks and associations exposed to lender liability claims if they Institutions Fund (CDFI Fund), which is have programs for furnishing sound and prescribed best management practices to a wholly owned Government constructive credit and related services their OFIs. corporation within the United States to young, beginning, and small (YBS) As stated earlier, the FCA is Department of the Treasury (Treasury), farmers and ranchers. According to the committed to the success of the OFI certifies and oversees CDFIs. statute, the YBS program of each FCS program. Providing funding and CDFIs attract capital for their direct lender association must comply liquidity to OFIs is an essential and operations from both private and public with policies prescribed by the board of integral part of the public policy their funding banks. Section 4.19(a) of mission of System banks to ensure that 16 OECD means the group of countries that are full the Act also states, ‘‘Such programs farmers and ranchers always have members of the Organization for Economic shall assure that such credit and Cooperation and Development, regardless of entry access to sound, adequate, and date, as well as countries that have concluded services are available in coordination constructive credit. The FCA offered special lending arrangements with the International with other units of the Farm Credit these seven suggestions in the hope that Monetary Fund’s General Arrangement to Borrow, System serving the territory and with they would encourage System banks to: excluding any country that has rescheduled its other governmental and private sources external sovereign debt within the previous 5 years. (1) Reach out to potential OFI applicants For purposes of United States banking operations, of credit.’’ (Emphasis added.) all federally regulated depository institutions are A CDFI that seeks funding, discount 15 Ibid. considered the equivalent of OECD banks. services, and other financial assistance

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from a Farm Credit bank should consult holding companies and carry full A Farm Credit bank asked the FCA to with the bank about how they can work guarantees from such parent entities; or clarify whether the three highest together to provide credit to YBS and (3) an institution that carries one of the NRSRO investment ratings (for low resource farmers and ranchers. three highest ratings from a nationally institutions that are risk weighted at 20 When feasible, the Farm Credit bank recognized statistical rating organization percent) include subset designations should encourage CDFIs and local FCS (NRSRO).18 OFIs are required by (e.g., AAA+, AA+, or A+). The FCA associations to coordinate their efforts to regulations to pledge full recourse on all responds that the regulation refers to the serve YBS and low resource farmers and loans they fund or discount with a Farm generic rating categories, not plus or ranchers. Credit bank. minus signs that show relative standing within each rating category. Under this III. Capital Risk Weighting Proposed § 615.5210 would establish a 50-percent risk weighting for OFIs regulation, for example, a rating of ¥ A. Background that: (1) Are not OECD banks but ‘‘AA ’’ would be within the second highest investment-grade ratings by an As discussed in the preamble to the otherwise meet similar capital and operational standards; and (2) carry an NRSRO. proposed rule, we have interpreted our Two Farm Credit banks asked the capital adequacy regulations as investment grade or higher NRSRO rating. The FCA proposed to retain a FCA whether the full recourse requiring Farm Credit banks to risk requirement for OFIs extended to their weight loans to OFIs at 100 percent. In 100-percent risk weighting for all loans to OFIs that do not qualify for the 20- parents. According to these contrast, existing § 615.5210(f)(2)(ii)(I) commenters, requiring both the parent percent or 50-percent risk-weight allows Farm Credit banks to risk weight and the OFI subsidiary to pledge full categories. loans to System associations at 20 recourse on the OFI’s loan (so the percent. This means Farm Credit banks B. Comments Received funding bank could risk weight it at 20 currently hold more capital (at a percent) could become a significant minimum) for loans to OFIs than loans We received 98 comments on capital impediment to the growth of the OFI to System associations, which in many risk weighting in response to our program. One of these commenters cases have similar structures and proposed rule. The comments came expressed concern that requiring the financial conditions as OFIs. The from 3 Farm Credit banks, a CDFI, an parent to pledge full recourse to the preamble to the ANPRM explained, in OFI that is affiliated with a group of System funding bank clashes with its detail, the risk-reducing features of FCS farmer cooperatives, the CUNA, the capital reasons for establishing an OFI associations that justified a 20-percent ICBA, and 91 commercial banks. The subsidiary. The FCA replies that the risk weighting.17 majority of the commenters supported rule requires full recourse from the OFI. The FCA acknowledged in the differentiating the risk weighting of Generally, the full recourse requirement preambles to the ANPRM and the loans to OFIs based on the structure and would not extend to an OFI’s parent, but proposed rule that many OFIs, risk-mitigating characteristics of the the System funding bank could require particularly commercial banks or their OFIs. it to provide such a guarantee as a affiliates, might pose no greater risk to The 3 Farm Credit banks generally condition for approving the OFI for their FCS funding bank than System supported the proposed capital risk- credit. associations. However, unregulated non- weighting rule for OFIs. However, these A Farm Credit bank suggested that the bank OFIs could expose the FCS bank commenters sought clarification of two final rule allow OFIs that are not OECD to greater risk than FCS associations and issues, and they requested two technical banks or their affiliates to qualify for a regulated OFIs. changes to the regulation. The CUNA 20-percent risk weighting if they receive The risk-weighting categories in supported the rule as proposed, while an investment grade or higher rating FCA’s capital regulations are patterned the ICBA and 47 bankers supported from a NRSRO. Under the proposed after the risk-weighting categories in the equal risk weighting for FCS rule, such OFIs do not qualify for a 20- 1988 Basel Accord, which apply to all associations and OFIs that are percent risk weighting unless a NRSRO depository institutions regulated by the depository institutions or their affiliates. rates them in one of the three highest other Federal bank regulatory agencies. Forty-four (44) commercial bank investment rating categories. However, As a result, many, but not all, OFIs have commenters supported equal risk- OFIs that are not OECD banks or their the same risk-reducing features as FCS weighting treatment for all OFIs and the affiliates could qualify for a 50-percent associations. FCS associations. The CDFI stated that risk weighting under the proposed rule The FCA proposed amendments to the final rule should require Farm if they receive an investment-grade § 615.5210 that would permit Farm Credit banks to risk weight all CDFIs at rating by a NRSRO and they meet the Credit banks to risk weight their loans 20 percent. The CDFI also stated that all other requirements of this regulation. to OFIs that are Federal- or state- CDFIs should be treated as equivalent to The FCA rejects the commenter’s regulated depository institutions, or OECD banks because of the CDFIs ‘‘good recommendation because it eliminates their affiliates, at 20 percent. Under this standing’’ status with Treasury. The the distinction in the regulation proposal, Farm Credit banks would agricultural credit cooperative OFI between OFIs that are risk weighted at continue to risk weight loans to OFIs expressed concern that the new 20 percent and those that are risk that are unregulated, or exhibit a higher regulation will increase the cost of weighted at 50 percent. NRSRO ratings risk profile at either 50 or 100 percent, funds to OFIs that are risk weighted at provide Farm Credit banks with a depending on certain factors. 100 percent. credible, objective, and independent The proposed rule would establish a standard for determining risk exposure 20-percent risk weighting for OFIs that 18 ‘‘Nationally recognized statistical rating from an OFI. Each risk-weighting are either: (1) An equivalent to an OECD organization’’ means an entity recognized by the category in our regulation is based on bank (Federal- or state-regulated Division of Market Regulation of the Securities and the System’s potential exposures to risk, depository institution); (2) subsidiaries Exchange Commission (or any successor Division) as well as risk mitigation factors. A (Commission) as a nationally recognized statistical of OECD equivalent banks or bank rating organization for various purposes, including lower investment rating from a NRSRO the Commission’s uniform net capital requirements means that an OFI (that is not an OECD 17 See 65 FR 21151 (April 20, 2000). for brokers and dealers. bank or its affiliate) exposes its System

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funding bank to greater risks which, in with the agency’s safety- and provide affordable credit on a consistent turn, justifies a 50-percent, not a 20- soundness-based regulations to basis to agriculture and rural America. percent, risk weighting. The FCA’s automatically equate CDFIs as Greater flexibility for the risk weighting approach is consistent with the equivalent to the risk weighting for of OFI loans should provide the Farm approach taken by the other federal OECD banks. However, CDFIs that are Credit banks additional incentives to bank regulatory agencies and pending community banks and credit unions expand their lending to both existing revisions to the Basel Accord. For this would probably qualify as OECD banks and new OFIs. reason, the final rule will require each and, therefore, a Farm Credit bank could Farm Credit bank to risk weight OFIs risk weight discounted CDFI loans at 20 IV. Regulatory Flexibility Act that are not OECD banks or their percent. Pursuant to section 605(b) of the affiliates at 20 percent only if they Forty-four (44) commercial bank Regulatory Flexibility Act (5 U.S.C. 601 achieve and maintain one of the three commenters took the position that the et seq.), the FCA hereby certifies that the highest investment-grade ratings from a risk weighting for all OFIs and FCS final rule will not have a significant NRSRO. associations should be the same. As economic impact on a substantial A Farm Credit bank asked the FCA to explained earlier, not all OFIs pose the number of small entities. Each of the amend a provision in the proposed rule same risks to their funding banks. Some banks in the System, considered so that an OFI can qualify for a 50- OFIs are not OECD banks or their together with its affiliated associations, percent risk weighting if its loan is affiliates. In other cases, nonbank OFIs has assets and annual income in excess guaranteed by a parent that receives an do not meet the capital, risk of the amounts that would qualify them investment grade or higher rating from identification and control, and as small entities. Therefore, System a NRSRO. The rule already allows an operational standards that apply to institutions are not ‘‘small entities’’ as OFI to qualify for a 20-percent risk OECD banks, or they do not carry an defined in the Regulatory Flexibility weighting if its parent: (1) Guarantees investment-grade rating from a NRSRO. Act. the loan; and (2) has one of the three For these reasons, not all OFIs should be highest NRSRO investment-grade risk weighted at 20 percent. List of Subjects ratings. The commenter sought this C. Final Rule 12 CFR Part 614 change so that the final rule applies consistent standards for risk weighting The final rule establishes a 20-percent Agriculture, Banks, Banking, Foreign OFIs at either 20 or 50 percent. The FCA risk weighting for OFIs that are either: trade, Reporting and recordkeeping agrees with the commenter and, (1) An equivalent to an OECD bank requirements, Rural areas. accordingly, the final rule includes this (Federal-or state-regulated depository 12 CFR Part 615 change. institution); (2) subsidiaries of OECD As discussed earlier, the agricultural equivalent banks or bank holding Accounting, Agriculture, Banks, credit cooperative OFI expressed companies and carry full guarantees Banking, Government securities, concern that this regulation will from such parent entities; or (3) an Investments, Rural areas. increase the cost of funds to OFIs that institution that carries one of the three are risk weighted at 100 percent. The highest investment-grade ratings from a I For the reasons stated in the preamble, FCA believes that this concern has no NRSRO. parts 614 and 615, chapter VI, title 12 of merit. All OFIs are currently risk Under final § 615.5210, a 50-percent the Code of Federal Regulations are weighted at 100 percent. Lowering the risk weighting applies to OFIs that: (1) amended as follows: risk weighting of some OFIs based on Are not OECD banks but otherwise meet lower risk profiles should not result in similar capital, risk identification and PART 614—LOAN POLICIES AND increased costs to other OFIs. Although control, and operational standards; and OPERATIONS (2) carry an investment-grade or higher the regulation differentiates between I 1. The authority citation for part 614 NRSRO rating, or the claim is OFIs on the basis of risk to the funding continues to read as follows: bank, the FCA does not expect that FCS guaranteed by a parent company with banks should raise the cost of funding such a rating. Authority: 42 U.S.C. 4012a, 4104a, 4104b, that they charge to OFIs that do not fall The final rule establishes a 100- 4106, and 4128; secs. 1.3, 1.5, 1.6, 1.7, 1.9, within the 20- or 50-percent risk- percent risk weighting for all OFI loans 1.10, 1.11, 2.0, 2.2, 2.3, 2.4, 2.10, 2.12, 2.13, that do not qualify for the 20-percent or 2.15, 3.0, 3.1, 3.3, 3.7, 3.8, 3.10, 3.20, 3.28, weighting categories. 4.12, 4.12A, 4.13B, 4.14, 4.14A, 4.14C, 4.14D, In response to the ICBA and other 50-percent risk-weight categories. OFIs 4.14E, 4.18, 4.18A, 4.19, 4.25, 4.26, 4.27, commercial bank commenters, the FCA that are well-capitalized and well- 4.28, 4.36, 4.37, 5.9, 5.10, 5.17, 7.0, 7.2, 7.6, confirms that the final rule treats FCS managed expose the System to less risk. 7.8, 7.12, 7.13, 8.0, 8.5 of the Farm Credit Act associations and OECD banks the same Therefore, FCS institutions need less (12 U.S.C. 2011, 2013, 2014, 2015, 2017, for risk-weighting purposes. As capital to support loans to these OFIs. 2018, 2019, 2071, 2073, 2074, 2075, 2091, discussed earlier, the CDFI inquired This approach is consistent with the 2093, 2094, 2097, 2121, 2122, 2124, 2128, about the risk weighting of CDFIs that direction from the pending Basel 2129, 2131, 2141, 2149, 2183, 2184, 2201, become OFIs. The FCA replies that Accord revisions, which are currently 2202, 2202a, 2202c, 2202d, 2202e, 2206, CDFIs as a group are not considered the under consideration. 2206a, 2207, 2211, 2212, 2213, 2214, 2219a, equivalent of OECD banks despite their Lowering the capital requirements for 2219b, 2243, 2244, 2252, 2279a, 2279a–2, 2279b, 2279c–1, 2279f, 2279f–1, 2279aa, ‘‘good standing’’ status with Treasury. most OFI loans will lower the operating 2279aa–5); sec. 413 of Pub. L. 100–233, 101 The certification criteria imposed on costs of the OFI program to Farm Credit Stat. 1568, 1639. CDFIs by Treasury are mission-based banks. This, in turn, should lower the rather than safety- and soundness-based cost of funds to well-capitalized and Subpart P—Farm Credit Bank and and, therefore, do not address risk well-managed OFIs. Lower funding Agricultural Credit Bank Financing of identification and control criteria as costs should enable these OFIs to reduce Other Financing Institutions required of the OECD banks by the interest rates charged to their borrowers. federal bank regulatory agencies. These results would advance the I 2. Revise § 614.4540(c) to read as Accordingly, it would be inconsistent System’s public policy mission to follows:

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§ 614.4540 Other financing institution guidelines for OFIs. The pricing Subpart H—Capital Adequacy access to Farm Credit Banks and guidelines must identify the specific agricultural credit banks for funding, components that make up the cost of I discount, and other similar financial 8. Amend § 615.5210 by adding new assistance. funds for OFIs, and the amount of these paragraphs (f)(2)(ii)(M); (f)(2)(iii)(C); and components expressed in basis points. * * * * * (f)(2)(iv)(E) to read as follows: (d) Upon request of any OFI or OFI (c) Underwriting standards. Each § 615.5210 Computation of the permanent applicant, that has or is seeking to Farm Credit Bank and agricultural credit capital ratio. bank shall establish objective policies, establish a funding relationship with the procedures, pricing guidelines, and loan Farm Credit Bank or agricultural credit * * * * * underwriting standards for determining bank, the bank must explain in writing (f) * * * the creditworthiness of each OFI the reasons for any variation in the (2) * * * applicant. A copy of such policies, overall funding costs it charges to OFIs procedures, guidelines, and standards and affiliated direct lender associations. (ii) * * * shall be made available, upon request to The written explanation must compare * * * * * each OFI and OFI applicant. the cost of funds that the Farm Credit (M) Claims on other financing * * * * * Bank or agricultural credit bank charges institutions provided that: the OFIs and affiliated direct lender I 3. Revise § 614.4550 to read as follows: (1) The other financing institution associations. When possible, the written § 614.4550 Place of discount. explanation shall compare the costs of qualifies as an OECD bank or it is A Farm Credit Bank or agricultural funding that the bank charges several owned and controlled by an OECD bank credit bank may provide funding, OFIs and Farm Credit associations that that guarantees the claim, or discounting, or other similar financial are similar in size. However, the Farm (2) The other financing institution has assistance to any OFI applicant. Credit Bank or agricultural credit bank a rating in one of the highest three However, a Farm Credit Bank or must not disclose financial or investment-grade rating categories from agricultural credit bank cannot fund, confidential information about any a NRSRO or the claim is guaranteed by discount, or extend other similar individual Farm Credit association. a parent company with such a rating, financial assistance to an OFI that and maintains its headquarters, or has more Subpart P—[Amended] (3) The other financing institution has than 50 percent of its outstanding loan endorsed all obligations it pledges to its volume to eligible borrowers who I 6. Amend part 614, subpart P by funding Farm Credit bank with full conduct agricultural or aquatic adding a new § 614.4595 to read as recourse. operations in the chartered territory of follows: another Farm Credit bank unless it (iii) * * * § 614.4595 Public disclosure about OFIs. notifies such bank in writing within five (C) Claims on other financing (5) business days of receiving the OFI’s A Farm Credit Bank or agricultural institutions that: application for financing. Two or more credit bank may disclose to members of (1) Are not covered by the provisions Farm Credit banks cannot the public the name, address, telephone simultaneously fund the same OFI. of paragraph (f)(2)(ii)(M) of this section, number, and Internet Web site address but otherwise meet similar capital, risk I 4. Revise § 614.4560(d) to read as of any affiliated OFI only if such OFI, follows: identification and control, and through a duly authorized officer, operational standards, or consents in writing. Each Farm Credit § 614.4560 Requirements for OFI funding (2) Carry an investment-grade or relationships. Bank and agricultural credit bank must adopt policies and procedures for higher NRSRO rating or the claim is * * * * * guaranteed by a parent company with (d) The borrower rights requirements requesting, obtaining, and maintaining such a rating, and in part C of title IV of the Act, and the the consent of its OFIs and for regulations in part 617 of this chapter disclosing this information to the (3) The other financing institution has shall apply to all loans that an OFI public. endorsed all obligations it pledges to its funds or discounts through a Farm funding Farm Credit bank with full PART 615—FUNDING AND FISCAL Credit Bank or agricultural credit bank, recourse. AFFAIRS, LOAN POLICIES AND unless such loans are subject to the (iv) * * * Truth-in-Lending Act, 15 U.S.C. 1601 et OPERATIONS, AND FUNDING seq. OPERATIONS (E) Claims on other financing institutions that do not otherwise * * * * * I qualify for a lower risk-weight category I 7. The authority citation for part 615 5. Amend § 614.4590 by adding new continues to read as follows: under this section. paragraphs (c) and (d) to read as follows: Authority: Secs. 1.5, 1.7, 1.10, 1.11, 1.12, * * * * * § 614.4590 Equitable treatment of OFIs and 2.2, 2.3, 2.4, 2.5, 2.12, 3.1, 3.7, 3.11, 3.25, 4.3, Dated: May 20, 2004. Farm Credit System associations. 4.3A, 4.9, 4.14B, 4.25, 5.9, 5.17, 6.20, 6.26, Jeanette C. Brinkley, * * * * * 8.0, 8.3, 8.4, 8.6, 8.7, 8.8, 8.10, 8.12 of the (c) Upon request, each Farm Credit Farm Credit Act (12 U.S.C. 2013, 2015, 2018, Secretary, Farm Credit Administration Board. Bank or agricultural credit bank must 2019, 2020, 2073, 2074, 2075, 2076, 2093, [FR Doc. 04–11849 Filed 5–25–04; 8:45 am] provide each OFI and OFI applicant, 2122, 2128, 2132, 2146, 2154, 2154a, 2160, BILLING CODE 6705–01–P that has or is seeking to establish a 2202b, 2211, 2243, 2252, 2278b, 2278b–6, funding relationship with the Farm 2279aa, 2279aa–3, 2279aa–4, 2279aa–6, Credit Bank or agricultural credit bank, 2279aa–7, 2279aa–8, 2279aa–10, 2279aa–12); a copy of its policies, procedures, loan sec. 301(a) of Pub. L. 100–233, 101 Stat. 1568, underwriting standards, and pricing 1608.

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DEPARTMENT OF THE INTERIOR portions of Missouri’s program for DEPARTMENT OF HOMELAND which we required remedial actions. SECURITY Office of Surface Mining Reclamation and Enforcement Need for Correction Coast Guard As published, the amendatory 30 CFR Part 925 33 CFR Part 117 language in the April 15, 2004, Federal Clarification of Substituted Federal Register notice inadvertently deleted [CGD08–04–021] Enforcement for Parts of Missouri’s existing regulatory text. This correction will restore that regulatory text which Drawbridge Operation Regulations; Permanent Regulatory Program and Atchafalaya River; Melville, LA Findings on the Status of Missouri’s contains important information for the Permanent Regulatory Program; State to use when it submits its proposal AGENCY: Coast Guard, DHS. Correction to regain full authority to implement its ACTION: Notice of temporary deviation regulatory program. AGENCY: Office of Surface Mining from regulations. Reclamation and Enforcement (OSM), List of Subjects in 30 CFR Part 925 SUMMARY: The Commander, Eighth Interior. Intergovernmental relations, Surface Coast Guard District, has issued a ACTION: Final rule; correction. temporary deviation from the regulation mining, Underground mining. governing the operation of the Melville SUMMARY: This document contains Dated: May 12, 2004. Railroad Vertical Lift Bridge across the corrections to the final rule published in Chad Calvert, Atchafalaya River, mile 107.4, near the Federal Register on Thursday, April Melville, St. Landry and Pointe Coupee 15, 2004 (69 FR 19927). Three Acting Assistant Secretary, Land and Parishes, Louisiana. This deviation paragraphs were inadvertently removed Minerals Management. allows the bridge to remain closed to from 30 CFR 925.18. This correction Accordingly, 30 CFR part 925 is navigation for two (2) four-hour will restore the previously-published amended by making the correcting segments each day on Friday and three paragraphs which list the revisions as set forth below. Saturday, June 11–12, 2004. The minimum requirements that must be deviation is necessary to repair and contained in Missouri’s proposal to PART 925—MISSOURI replace rails on the bridge. OSM to reassume full authority of DATES: This deviation is effective from Missouri’s surface coal mining and I 1. The authority citation for part 925 7 a.m. on Friday June 11, 2004, until 5 reclamation program. continues to read as follows: This rule is being made effective p.m. on Saturday June 12, 2004. immediately in order to expedite the Authority: 30 U.S.C. 1201 et seq. ADDRESSES: Materials referred to in this actions required of the State to resume document are available for inspection or full authority for its approved program. I 2. Section 925.18 is amended by copying at the office of the Eighth Coast EFFECTIVE DATE: May 26, 2004. adding paragraphs (c)(1), (c)(2), and Guard District, Bridge Administration (c)(3) to read as follows: FOR FURTHER INFORMATION CONTACT: John Branch, Hale Boggs Federal Building, room 1313, 500 Poydras Street, New W. Coleman, Mid-Continent Regional § 925.18 State remedial actions. Coordinating Center, Office of Surface Orleans, Louisiana 70130–3310 between * * * * * Mining, 501 Belle Street, Alton, Illinois 7 a.m. and 3 p.m., Monday through 62002. Telephone: (618) 463–6460. (c) * * * Friday, except Federal holidays. The telephone number is (504) 589–2965. SUPPLEMENTARY INFORMATION: (1) Funding. The proposal must The Bridge Administration Branch of demonstrate to the satisfaction of OSM Background the Eighth Coast Guard District a commitment to fully fund the maintains the public docket for this On August 4, 2003, OSM notified the Missouri program. Governor of Missouri that serious temporary deviation. problems existed that were adversely (2) Staffing. The proposal must FOR FURTHER INFORMATION CONTACT: affecting the Missouri Department of demonstrate to the satisfaction of OSM David Frank, Bridge Administration Natural Resources implementation and a commitment to hire a sufficient Branch, telephone (504) 589–2965. enforcement of the Missouri surface coal number of qualified personnel to SUPPLEMENTARY INFORMATION: The Union mining and reclamation program. In comply with all inspection and Pacific Railroad has requested a accordance with the provisions of 30 enforcement, permitting, and bonding temporary deviation in order to remove CFR 733.12(f), we announced our requirements of the approved Missouri and replace rails on the Melville decision, effective August 22, 2003, to program. Railroad Vertical Lift Bridge across the institute direct Federal enforcement for (3) Adherence to approved program. Atchafalaya River, mile 107.4, near those portions of the Missouri program The proposal must include provisions, Melville, St. Landry and Pointe Coupee that the State could not adequately policy statements, and other affirmative Parishes, Louisiana. The repairs are implement and enforce. With the evidence sufficient to assure OSM that necessary to ensure the safety of the substitution of Federal enforcement the MLRP will be in full compliance at bridge. This temporary deviation will authority, we outlined a process by all times with the provisions of the allow the bridge to remain in the closed- to-navigation position from 7 a.m. until which Missouri could regain full Missouri program. authority for its program. 11 a.m. and from 1 p.m. until 5 p.m. on In the April 15, 2004, Federal * * * * * Friday, June 11, 2004, and Saturday, Register (69 FR 19927), we further [FR Doc. 04–11707 Filed 5–25–04; 8:45 am] June 12, 2004. clarified our position regarding the BILLING CODE 4310–05–P The bridge has a vertical clearance of portions of the Missouri program that four feet above mean high water in the we directly enforce and set forth our closed-to-navigation position and 54 findings regarding the status of those feet above mean high water in the open-

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to-navigation position. Navigation at the before this date will continue to be attorney, or appointment of a new site of the bridge consists mainly of effective. power of attorney would not need to be tows with barges and some recreational FOR FURTHER INFORMATION CONTACT: filed in each patent application if a pleasure craft. Due to prior experience, Karin Ferriter ((703) 306–3159) (Office Customer Number Data Change Request as well as coordination with waterway of the Deputy Commissioner for Patent (PTO/SB/124) is filed. As a result, if a users, it has been determined that this Examination Policy), Mary Hannon patent attorney or patent agent is to closure will not have a significant effect ((703) 308–8910, ext. 137) (Office of the begin to represent a client, or is on these vessels. No alternate routes are Commissioner for Trademarks), or discontinuing representation of a client, available. The bridge will be able to Robert J. Spar ((703) 308–5107) (Office on a particular set of applications, and, open for emergencies. of the Deputy Commissioner for Patent if the power of attorney for that set of In accordance with 33 CFR 117.35(c), Examination Policy), directly by phone, applications was originally to the patent this work will be performed with all due or by facsimile to (703) 872–9411, or by practitioners associated with a Customer speed in order to return the bridge to mail addressed to: Mail Stop Number, then the list of patent normal operation as soon as possible. Comments—Patents, Commissioner for practitioners associated with the This deviation from the operating Patents, P.O. Box 1450, Alexandria, VA Customer Number should be changed to regulations is authorized under 33 CFR 22313–1450. reflect the addition or deletion. When 117.35. Customer Number practice is used, a SUPPLEMENTARY INFORMATION: A purpose separate document does not need to be Dated: May 13, 2004. of this final rule is to limit the number filed by applicant for each application Marcus Redford, of patent practitioners that a patent in which the list of practitioners Bridge Administrator. applicant, or an assignee of the patent associated with the Customer Number is [FR Doc. 04–11893 Filed 5–25–04; 8:45 am] applicant, can name in a power of to be changed; only one Customer attorney. If more than ten registered BILLING CODE 4910–15–P Number Data Change Request is patent attorneys or registered patent required to eliminate any patent agents are to be appointed, then the practitioners who should no longer be Office’s Customer Number practice must DEPARTMENT OF COMMERCE associated with the Customer Number. be used. This change is necessary to Alternatively, a new power of attorney Patent and Trademark Office eliminate the undue processing burden to a list of patent practitioners or to the on the Office when a power of attorney patent practitioners associated with a 37 CFR Parts 1, 3 and 5 naming more than ten patent different customer number may be filed [Docket No.: 2003–P–019] practitioners is submitted in patent in each application in which the power applications. In addition, a purpose of RIN 0651–AB63 of attorney should be changed. this final rule is to eliminate the The rules pertaining to power of associate power of attorney practice in attorney are revised to reflect Customer Revision of Power of Attorney and patent cases. An associate power of Assignment Practice Number practice, a practice wherein an attorney is not necessary for a patent applicant or an assignee of the entire AGENCY: United States Patent and practitioner to take most actions in a interest of the applicant in a patent Trademark Office, Commerce. patent application. Instead of filing an application can give power of attorney ACTION: Final rule. associate power of attorney, a patent to a list of registered patent practitioners practitioner can file an ‘‘Authorization associated with a Customer Number. SUMMARY: The United States Patent and to Act in a Representative Capacity’’ See Manual of Patent Examining Trademark Office (Office) is revising the (note the sample form posted on the Procedure (8th ed. 2001) (Rev. 1, Feb. rules of practice to allow for more Office’s Internet Web site at: http:// 2003) (MPEP), Section 403, for a efficient processing of powers of www.uspto.gov/web/forms/sb0084.pdf). description of Customer Number attorney and assignment documents Another purpose of this final rule is to practice. The rules are also revised to within the Office. For example, the eliminate an original assignment explain the requirements of a power of Office will require applicants to use the document from the list of documents attorney and to limit the number of Office’s Customer Number practice if that may be submitted for recordation. practitioners who may be given a power more than ten registered patent This is because the Office shall no of attorney without using Customer practitioners are to be made of record. longer be returning assignment Number practice. Furthermore, the In addition, the Office is eliminating documents after they have been scanned patent rules are amended to discontinue some mail stops (i.e., CPA, Provisional into the Office’s electronic assignment the ‘‘associate’’ power of attorney Patent Application) that were found not database, and any assignee that submits practice, to clarify the procedures be useful in routing correspondence the original assignment document will related to revocation of power of within the Office, and creating a new be unable to retrieve the document. attorney, and to clarify how a registered mail stop (Licensing and Review) to The Office provides for the use of a practitioner may sign a document in a assist the Office in the proper routing of Customer Number to identify either an representative capacity. national security classified and secrecy address for patent-related Documents affecting the title to a order papers. Finally, because the Office correspondence, or a set of patent patent or trademark property (e.g., is discontinuing the current Office attorneys and agents who may be assignments, or security interests) are practice of returning patent and identified with a patent application as currently recorded in the Office’s trademark assignment documents patent practitioners of record. Customer assignment database, upon submission submitted by mail for recording in the Number practice permits the of the document with the appropriate assignment database, only copies of correspondence or fee address, or the cover sheet and the fee required by 35 assignment documents may be list of practitioners of record to be easily U.S.C. 41(d)(1). In addition, Government submitted for recording in the Office’s changed in a large number of patent Interests are recorded, upon submission Assignment records. applications by filing a single request of the document, as required by DATES: Effective Date: June 25, 2004. for Customer Number data change. A Executive Order 9234 of February 18, Any associate power of attorney filed separate revocation of power of 1944 (9 FR 1959, 3 CFR 1943–1948

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Comp., p. 303). Since 1995, assignment routing of correspondence within the ‘‘Power of attorney’’ is defined in documents have been recorded in the Office. paragraph (a)(1) of § 1.32 as a written Office’s Assignment database without Section 1.12: Section 1.12(b) is document by which a principal stamping or otherwise marking the amended to replace ‘‘has not been designates a registered patent attorney document that was submitted for published under 35 U.S.C. 122(b) are or a registered patent agent (collectively recordation. The automated system that not available to the public’’ with ‘‘is ‘‘patent practitioner’’) to act on his or receives documents for recordation open to the public pursuant to § 1.11 or her behalf. assigns the reel and frame number to the for which copies or access may be ‘‘Principal’’ is defined in paragraph document and places the recordation supplied pursuant to § 1.14, are (a)(2) of § 1.32 as either the applicant for stampings on the images that are stored available to the public’’ in order to patent (§ 1.41(b)) or the assignee of the in the automated system. The Office is clarify the assignment records that are entire interest of the applicant, and the increasing the integrity of its internal available to the public. Section 1.12(b) entity who executes a power of attorney patent application record maintenance is further amended to provide that designating one or more agents to act on by adopting a new electronic data copies of any such assignment records his or her behalf. An appointment by processing system for the storage and and related information that are not fewer than all of the applicants, or maintenance of all the records available to the public shall be assignees of the entire interest of the associated with patent applications. The obtainable only upon written authority applicants requires a petition under new system includes the process of of the applicant or applicant’s assignee, § 1.183 to waive the requirement of scanning all incoming papers to create patent attorney, or patent agent or upon § 1.32(b)(4) that the applicant, or the an image file of the papers associated a showing that the person seeking such assignee of the entire interest of the with patent applications. Papers that are information is a bona fide prospective or applicant sign the power of attorney. scanned are stored, and then destroyed actual purchaser, mortgagee, or licensee The term ‘‘patentee’’ has not been according to a record retention of such application, unless it shall be included in this definition because use schedule. Consistent with this new necessary to the proper conduct of of the term ‘‘patentee’’ would make the practice, the Office will discontinue the business before the Office or as rule unnecessarily complicated. practice of returning assignment provided in part 1. Although the term ‘‘patentee’’ often is a As revised, § 1.12(b) more clearly documents that were mailed to the reference to the assignee, the patentee provides, for example, for an Office, and will require assignment could also be the inventors, or if an application that is relied upon under 35 documents to be submitted on 81⁄2 by inventor is deceased or legally U.S.C. 120 in an application that has 11-inch paper (21.6 by 27.9 cm) (‘‘letter incapacitated, the inventors and the issued as a patent, any assignment size’’) or DIN size A4 (21.0 by 29.7 cm). legal representative of such an inventor. records relating to the parent To assist applicants in identifying the application could be considered to An inventor who could not be reached application or patent to which a Notice relate to the patent. Before the or refused to join in the filing of a patent of Recordation relates, the Notice has amendment to § 1.12(b), the text of the application would not be an applicant been revised to reflect the title of the rule suggested that the assignment as set forth in § 1.41(b), but would still invention and docket number stored in records for the parent application were be a patentee, but once a patent has the Office’s electronic records, if the not available to the public. This was not issued, the signature of the nonsigning notice of recordation is for a single the intended construction, and was inventor should still not be required on property (application or patent). Any inconsistent with MPEP § 301.01. As any power of attorney. Accordingly, the docket number included on the revised § 1.12(b) provides that the term ‘‘patentee’’ does not necessarily Assignment Cover sheet will only be assignment records for the parent reference the same group of individuals used in the Office’s electronic financial application of a patent, or an as the term ‘‘applicant’’ and has not records for purposes of processing the application that has published under 35 been used in the rules so that the recordation fee, but will not be entered U.S.C. 122(b), are open to public applicant, not necessarily the patentee, into other electronic records for the inspection. could change the power of attorney, for patent or patent application. Section 1.31: Section 1.31 is amended example, in an application that has issued as a patent. Discussion of Specific Rules to revise the title to refer to ‘‘registered patent attorney or patent agent’’ and to ‘‘Revocation’’ is defined in paragraph The Office is amending sections of introduce the term ‘‘power of attorney.’’ (a)(3) of § 1.32 as the cancellation by the 1.1, 1.12, 1.31, 1.33, 1.34, 1.36, 1.53, Section 1.31 is also revised to add principal of the authority previously 1.363, 3.1, 3.21, 3.24, 3.25, 3.27, 3.31, ‘‘United States’’ before ‘‘Patent and given to a registered patent attorney or 3.34, 3.41, 3.81, and 5.1 of title 37 of the Trademark Office’’ in the definition of registered patent agent to act on his or Code of Federal Regulations (CFR), and ‘‘Office’’ to properly reflect the current her behalf. adding new § 1.32 to title 37 CFR. name of the Office in the rule. See 35 ‘‘Customer Number’’ is defined in Section 1.1: Section 1.1(a)(4)(i) is U.S.C. 1(a). paragraph (a)(4) of § 1.32 to be a number amended to add ‘‘submitted by mail’’ Section 1.32: New § 1.32 sets forth that may be used to: (i) Designate the and to delete ‘‘or under § 3.81 of this definitions related to power of attorney. correspondence address of a patent chapter’’ to require that assignments Section 1.32 does not apply to power of application or patent such that the submitted by mail contemporaneously attorney in an international application correspondence address for the patent with a request to issue a patent to an (§ 1.455). The terms ‘‘power of application or patent would be the assignee be sent to Mail Stop attorney,’’ ‘‘principal,’’ ‘‘revocation,’’ address associated with the Customer Assignment Recordation Services and ‘‘Customer Number’’ are defined, Number; (ii) designate the fee address instead of Mail Stop Issue Fee in order and the requirements for a power of (§ 1.363) of a patent by a Customer to more efficiently direct assignment attorney are set forth. The term ‘‘patent Number such that the fee address for the documents. Section 1.1 is also amended practitioner’’ is not separately defined, patent would be the address associated to remove paragraph (f). The Office has but is a collective reference to a with the Customer Number; and (iii) determined that Mail Stop Provisional registered patent attorney or registered specify, in a power of attorney, that each Patent Application is not useful in the patent agent. of the patent practitioners associated

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with a Customer Number have a power paper filed pursuant to § 1.32(c)(3). If address, and the declaration gives a of attorney. more than ten patent practitioners are different address (i.e., the address Section 1.32(b) sets forth the listed on a power of attorney, and no associated with a Customer Number) as requirements for a power of attorney, separate paper under § 1.32(c)(3) is the correspondence address, the Office other than a power of attorney in an filed, then no patent practitioners will will use the typed correspondence international application (see § 1.455 for be made of record. If a separate paper address as included on the ADS. In the the power of attorney in an international is not provided and a patent practitioner experience of the Office, the ADS is the application and note that Customer later attempts to sign a batch update most recently created document and Number practice cannot be used in an request to request that the address tends to have the most current address. international application). To comply associated with the Customer Number After the correspondence address has with § 1.32(b), the power of attorney, in be used for the correspondence address been entered according to the above an application other than an and/or the fee address for the patent procedure, it will only be changed international application, must: (1) Be applications listed on the spreadsheet pursuant to § 1.33(a)(1). in writing; (2) name one or more (see Notice of Elimination of Batch A Customer Number merely provided representatives in compliance with (c) Update Practice to Change Power of in correspondence without an of this section; (3) give the Attorney, 1272 Off. Gaz. Patent Office instruction to use the Customer Number representative power to act on behalf of Notices 24 (July 1, 2003)), the request for the correspondence address or for the principal; and (4) be signed by the will be rejected because the patent any other purposes, e.g., a Customer applicant for patent (§ 1.41(b)) or the practitioner is not of record. Applicant Number that is adjacent the heading of assignee of the entire interest of the may then submit a newly executed the paper, is not a specific direction to applicant. Furthermore, pursuant to power of attorney complying with use the Customer Number for any § 1.32(c), a power of attorney may only § 1.32, or submit a copy of the purpose. name as representative: (1) One or more previously filed power of attorney Section 1.33(b)(1) is revised to change joint inventors (§ 1.45); (2) those accompanied by a separate paper the reference from § 1.34(b) to new registered patent practitioners indicating which ten practitioners are to § 1.32(b). associated with a Customer Number; or be made of record pursuant to Section 1.33(b)(2) is revised to change (3) ten or fewer registered patent § 1.32(c)(3). § 1.34(a) to § 1.34 to be consistent with attorneys or registered patent agents (see Customer Number practice allows the the revision to § 1.34. § 10.6 of this subchapter)(patent Office to enter a single five or six digit Section 1.33(c) revised to change the practitioners). Except as provided in number into the Office computer system cross-reference to § 1.32(b) instead of § 1.32(c)(1) or (c)(2), the Office will not instead of a large number of patent § 1.34(b) and to change the reference to recognize more than ten patent practitioners and is a more appropriate § 1.34(a) to § 1.34 to be consistent with practitioners as being of record in an use of Office resources than continuing the revision to § 1.34. application or patent. If a power of to permit applicants to give a power of Section 1.34: Section 1.34 is revised attorney names more than ten patent attorney to an unlimited number of to change the title to ‘‘Acting in a practitioners, such power of attorney practitioners. See MPEP § 403. Representative Capacity.’’ The must be accompanied by a separate Section 1.33: Section 1.33(a) is paragraph designation for paragraph (a) paper indicating which ten patent revised to reflect Customer Number and ’’, pursuant to § 1.31,’’ are deleted. practitioners named in the power of practice. If applicant provides, in a In addition, ‘‘the registered patent attorney are to be recognized by the single document, both a complete typed attorney or patent agent should specify Office as being of record in application address and a Customer Number and his or her registration number with his or patent to which the power of attorney requests that both be used for the or her signature’’ is changed to ‘‘the is directed. correspondence address, the address registered patent attorney or patent New § 1.32(c)(3) sets a limit on the associated with the Customer Number agent must specify his or her name and number of patent practitioners who can will be used. Section 1.33(a) is revised the registration number with his or her be given a power of attorney without to include the following sentence: ‘‘If signature.’’ When a registered patent using Customer Number practice more than one correspondence address attorney or patent agent acts in a because it is extremely burdensome for is specified in a single document, the representative capacity, it should be the Office to manually enter a long list Office will establish one as the clear who is signing the paper. Because of patent practitioners, particularly correspondence address and will use signatures are not always legible and where the same list of patent the address associated with a Customer because sometimes the wrong practitioners is to be entered for a large Number, if given, over a typed registration number is given, it is number of applications, and to update correspondence address.’’ Applicants necessary for the registered patent that listing. Applicants desiring to will often specify the correspondence attorney or agent to include his or her appoint a large number of patent address in more than one paper that is name so that the identity of the person practitioners may continue to do so, but filed with an application, and the who is acting in a representative Customer Number practice will be address given in the different places capacity may be identified. required in order to have more than ten sometimes conflicts. Where the Paragraph (b) of § 1.34 is deleted. patent practitioners recognized by the applicant specifically directs the Office With Customer Number practice, the Office as being of record and reflected to use a correspondence address in more associate power of attorney practice set in Office computer systems. See than one paper, priority will be forth in § 1.34(b) is no longer necessary § 1.32(c)(2). accorded to the correspondence address because once power of attorney is given If more than ten patent practitioners specified in the following order: (1) to the patent practitioners associated have been named in a combined Application data sheet (ADS); (2) with a Customer Number, the list of declaration and power of attorney (e.g., application transmittal; (3) oath or patent practitioners of record may easily from an earlier filed application (see declaration (unless power of attorney is be changed. Additionally, for a patent § 1.63(d)(1)(iv))), then the Office of more current); and (4) power of practitioner to have the most Initial Patent Examination will enter the attorney. Accordingly, if the ADS information with which to represent his practitioners indicated on the separate includes a typed correspondence client, the patent practitioner needs to

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have access to the private Patent § 1.34 may conduct an interview with ‘‘Notice Regarding Change in Power of Application Information Retrieval an examiner. See MPEP § 713.05. A Attorney.’’ A power of attorney to the (private PAIR) system on the Office’s patent practitioner who is acting in a patent practitioners associated with a Internet Web site (http:// representative capacity can also file Customer Number that is filed PAIR.uspto.gov), and a patent amendments and other papers subsequent to another power of attorney practitioner can only have direct access (§ 1.33(b)(2)). A patent practitioner who will be treated as a revocation of the to private PAIR if he or she is associated is acting in a representative capacity previously granted power of attorney. with the Customer Number, and if the pursuant to § 1.34 may not, however, The Office can only recognize one Customer Number is used for the change the correspondence address Customer Number at a time for power of correspondence address of the (§ 1.33(a)(2)) (except where an executed attorney purposes. When the power of application. Private PAIR provides oath or declaration has not been filed, attorney is to the patent practitioners patent practitioners with access to the and the patent practitioner filed the associated with a Customer Number, the Office’s computer systems that track the application)), expressly abandon the power of attorney is considered to be patent file history, and, if the application without filing a continuing revoked when the power of attorney to application is maintained in the Image application (§ 1.138(b)), or sign a the practitioners associated with the File Wrapper (IFW) system, access to terminal disclaimer (§ 1.321(b)(1)(iv)). A Customer Number is revoked. The the images of the documents in the file patent practitioner who is signing on revoked power of attorney may be history. Furthermore, private PAIR behalf of the assignee of the entire replaced with either a new power of provides pro se applicants and patent interest may (i.e., not signing in a attorney to a new Customer Number or practitioners with information about representative capacity or as a patent a power of attorney to a new list of recently mailed correspondence from practitioner of record), however, sign patent practitioners. A power of the Office for a particular Customer these same documents upon compliance attorney is not considered revoked Number. Furthermore, private PAIR with § 3.73(b), if the practitioner is when the list of patent practitioners provides an explanation of any patent authorized to act on behalf of the associated with a Customer Number is term extension or patent term assignee. changed (as by filing a Request for adjustment calculations for the patent A patent attorney or agent who has Customer Number Data Change (PTO/ application. A patent practitioner who been given a power of attorney cannot SB/124)). When the power of attorney is does not have access to private PAIR is change the power of attorney from the revoked, a single notice is mailed to the disadvantaged in representing a client set of patent practitioners appointed by correspondence address in effect before compared to a practitioner who has the applicant or assignee of the entire the power of attorney was revoked. An access to private PAIR. See the interest of the applicant to a Customer associate registered patent attorney or discussion with respect to comment 9 Number (or change from one Customer patent agent is not separately informed below. Number to another). To appoint a new of a revocation. As a result, § 1.36(a) has A government entity or assignee may power of attorney, the applicant or been revised to no longer suggest that have multiple law firms or sets of assignee of the entire interest of the such an associate practitioner would be attorneys working on their patent applicant must be involved and must separately notified of the revocation of applications. Such an entity should sign the power of attorney. Where a power of attorney. consider having multiple Customer large number of patent applications of a When power of attorney is given to Numbers, with a separate Customer single assignee are involved, the the registered patent practitioners Number for each set of patent attorneys, assignee may wish to consider giving associated with a Customer Number, for and having at least one in-house patent the patent practitioners a power of example with PTO/SB/81, the list of practitioner listed on each listing of attorney that is not specific to an patent practitioners associated with the patent practitioners associated with a application, similar to the General Customer Number is changed by Customer Number so that the Power of Attorney used in Patent changing the data associated with the government entity or assignee has Cooperation Treaty (PCT) practice, and Customer Number (using, for example access to private PAIR for all of their having one of the patent practitioners PTO/SB/124 (2 pages 124A & 124B), patent applications. with general power of attorney take Request for Customer Number Data An applicant or assignee of the entire action by submitting a copy of the Change). No notice is given to the patent interest of the applicant who gives a power of attorney and a statement in practitioners who are added or removed power of attorney to a limited number compliance with § 3.73(b). Form PTO/ from the Customer Number. of patent practitioners has expressed a SB/80 is available for this purpose and Section 1.36(b) provides that when desire to be represented by only those is posted on the Office’s Internet Web the power of attorney for an application patent practitioners. As § 1.34 is revised, site at www.uspto.gov, under forms. is given to the practitioners associated if Customer Number practice is not Section 1.36: Section 1.36 is revised with a Customer Number, all of the used, an applicant or assignee of the to include new paragraphs (a) and (b) so patent practitioners associated with the entire interest of the applicant will be that revocation of power of attorney and Customer Number will not be permitted required to sign a new power of attorney withdrawal as attorney or agent of to withdraw if an application with the in order for an associate practitioner to record are addressed in separate power of attorney has an Office action be ‘‘of record’’ in addition to the paragraphs. In addition, ‘‘or to which a reply is due and insufficient specifically identified principal patent authorization of agent’’ is deleted time remains in the time period for practitioner. Of course, a registered because the term ‘‘power of attorney’’ reply for applicant to prepare a reply. patent practitioner may still act in a has been defined to include an See MPEP § 402.06. representative capacity pursuant to authorization of an agent. The cross- Section 1.53: Section 1.53 is amended § 1.34 (by providing his or her name and reference to § 1.31 is changed to by removing paragraph (d)(9) and a registration number with his or her § 1.32(b). redesignating paragraph (d)(10) as signature), and the rule changes do not Section 1.36(a) addresses revocation paragraph (d)(9). The Office has change this flexibility. A patent of a power of attorney. A registered determined that Mail Stop CPA is not practitioner who is acting in a patent attorney or patent agent is useful in the routing of correspondence representative capacity pursuant to notified of any revocation with a within the Office.

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Section 1.363: Section 1.363 is Section 3.24: Section 3.24 is revised reduced to 81⁄2 by 11-inch or DIN size amended by adding paragraph (c), to include two paragraphs, namely, A4 paper for submission to the Office which states ‘‘A fee address must be an paragraphs (a) and (b). (e.g., by photocopying onto letter-size address associated with a Customer New paragraph (a) of § 3.24 addresses paper). Sheets of paper that are either Number.’’ At the time of issue fee documents and cover sheets for 81⁄2 by 11 inches (21.6 by 27.9 cm) or payment, applicants may designate a fee electronic submissions (e.g., patent DIN size A4 (21.0 by 29.7 cm) are address for maintenance fee purposes assignment documents filed via the required for scanning purposes. (hereafter, fee address) by submitting a Electronic Filing System (EFS) or the Section 3.25: Section 3.25 is amended ‘‘Fee Address’’ Indication form (PTO/ Electronic Patent Assignment System to delete paragraph (a)(1) and renumber SB/47) as an attachment to the Fee(s) (EPAS)), and requires all documents paragraphs (a)(2) through (4) as (a)(1) Transmittal (PTOL–85B). If no Customer submitted electronically to be submitted through (3), respectively. Paragraph Number was previously acquired from as digitized images in Tagged Image File (a)(1) is deleted to prohibit applicants the Office for the address being Format (TIFF). In addition, when from submitting the original assignment 1 designated as the fee address, a Request printed to a paper size of 8 ⁄2 by 11 document (because applicants should for Customer Number form (PTO/SB/ inches (21.6 by 27.9 cm)(‘‘letter size’’) or retain the original of the assignment 125) should also be attached to the DIN size A4 (21.0 by 29.7 cm), the document). Paragraph (a)(1) of § 3.25, as Fee(s) Transmittal (PTOL–85B). If a fee document must be legible and a one- renumbered, is further revised to insert address is established in an allowed inch (2.5 cm) margin must be present on ‘‘original’’ before ‘‘document’’ in order application or patent, the Office will all sides. to clarify that only a copy of an original New paragraph (b) of § 3.24 addresses send all maintenance fee assignment document may be submitted documents and cover sheets for paper for recording. correspondence (such as maintenance and facsimile submissions. Section Section 3.25(c) is revised to add fee reminder notices) to the fee address; § 3.24(b) provides that for paper paragraph (1) to state that electronic and the Office will send all other submissions (e.g., documents that are submissions (e.g., ETAS for trademark correspondence, to the correspondence mailed to the Office), the original assignment documents) must be address of record. See Customer document may no longer be submitted. attached as a digitized image in Tagged Number Required in Order to Establish Section 3.24(b) provides that ‘‘[e]ither a Image File Format (TIFF), to move the a Fee Address, 1261 Off. Gaz. Pat. Office copy of the original document or an existing requirements for paper 19 (August 6, 2002). extract of the original document’’ must submissions into paragraph (2), and to Section 3.1: Section 3.1 is revised to be submitted for recordation. Section specify that the document (copy) identify which trademark applications 3.24(b) also explains why original submitted for recording must have a are covered by 37 CFR part 3, and to documents should not be submitted for one-inch margin when printed on 8 1⁄2 delete ‘‘or a transfer of its entire right, recording: ‘‘The Office will not return by 11 inch (21.6 by 27.9 cm) or DIN size title and interest in a’’ so that the recorded documents, so original A4 (21.0 cm by 29.7 cm) paper. Legal- definition of an assignment includes a documents must not be submitted for size paper is no longer permitted. See transfer of part of the right, title and recording.’’ The Office is moving to the discussion of this change above for interest in a registered mark or a mark uniform processing of incoming papers, patents (§ 3.24). for which an application to register has with incoming papers being scanned Section 3.27: Section 3.27 is revised been filed. Section 3.1 is also revised to upon receipt, electronically routed to change ‘‘to be recorded’’ to add ‘‘United States’’ before ‘‘Patent and within the Office, and an appropriate ‘‘submitted by mail for recordation’’ Trademark Office’’ in the definition of reply being transmitted to applicant or because documents and cover sheets ‘‘Office’’ to properly reflect the current his representative. With this uniform submitted for recording may be faxed or name of the Office in the rule. See 35 procedure, the Office will not return or electronically submitted to the Office U.S.C. 1(a). retain assignment documents submitted and need not be mailed. Only for recordation. As a result, the Office is documents submitted by mail need to be Section 3.21: Section 3.21 is revised not permitting the submission of addressed as set forth in the rule. to change ‘‘its date of execution, name originals of assignment documents, and Section 3.27 is also revised to delete ‘‘or of each inventor, and title of the instead is requiring that a copy or an with a request under § 3.81’’. As invention’’ to ‘‘the name of each extract of an original document be explained with respect to § 3.81, when inventor and the title of the invention.’’ submitted. The term ‘‘an extract of the an applicant requests a patent to issue Section 3.21 is also revised to change original document’’ is being added to to an assignee, the assignment ‘‘the provisional application by name of reflect the current practice of submitting document should be separately each inventor and title of the invention’’ redacted copies of assignment submitted for recordation because to ‘‘the provisional application by the documents, where part of an assignment inclusion of the assignment document name of each inventor and the title of document discusses matters other than with the request to issue the patent to the invention’’ by adding ‘‘the’’ before assignment of interests related to a the assignee slows down the recordation ‘‘name’’ and ‘‘title.’’ patent. process. The phrase ‘‘its date of execution’’ has Section 3.24 is further revised to Section 3.31: Section 3.31(a)(7) is been deleted from § 3.21 because the provide, in paragraph (b), that revised to set forth the requirements for date of execution of a declaration is no documents (copies) submitted for signature of patent and trademark cover longer required on a declaration (see recording must be on sheets of paper sheets filed electronically. These MPEP § 602.05 and because the having a size of 81⁄2 by 11 inches (21.6 requirements correspond to the application could be executed on more by 27.9 cm)(‘‘letter size’’) or DIN size A4 requirements set forth in §§ 2.33(d) and than one date, and thus there may be no (21.0 by 29.7 cm). ‘‘Legal-size’’ (81⁄2 by 2.193(c)(1)(iii) of this chapter for single date of execution). Accordingly, 14 inch or 21.64 by 33.1 cm) sheets of electronically transmitted trademark the date of execution of the application paper are no longer permissible. If the filings. is not particularly useful in original assignment document is on Trademark assignments may be identification of the patent application ‘‘legal size’’ sheets of paper, the submitted electronically with the and is deleted as unnecessary. assignment document should be Electronic Trademark Assignment

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System (ETAS), which is available on Section 3.81: Section 3.81(a) is § 1.20(a)) and the processing fee set the Office’s Internet Web site. See http:/ revised to change ‘‘name(s)’’ to ‘‘name’’ forth in § 1.17(i) of this chapter.’’ This /etas.uspto.gov/. Patent assignments and ‘‘assignee(s)’’ to ‘‘assignee’’ because modifies the practice relating to may be electronically submitted using a under rules of statutory and regulatory issuance of a patent to an assignee by similar tool, the Electronic Patent construction, the singular includes the requiring that after payment of an issue Assignment System (EPAS), and may plural unless the context indicates fee, a request for a certificate of also be submitted using EFS. When otherwise. Furthermore, § 3.81(a) is correction must be filed in order to submitting a copy of an assignment amended to change ‘‘should be obtain issuance of the patent to an using ETAS or EPAS, the cover sheet is accompanied by the assignment and assignee. Thus, where assignment completed and signed electronically. As either a direction to record the information is submitted after payment with electronic submission of a assignment in the Office pursuant to of the issue fee, the patent document trademark application, a signature may § 3.28, or a statement under § 3.73(b)’’ to will not include the assignment be applied to an assignment cover sheet ‘‘must state that the document has been information, but the assignment by either: (1) Placing a symbol filed for recordation as set forth in information will be included in a comprised of letters, numbers, and/or § 3.11.’’ When an assignment document Certificate of Correction. Furthermore, punctuation marks between forward is submitted for recording, the preferred the practice of allowing a patent to issue slash marks in the signature block on submission is by facsimile to (703) 306– to an assignee when a § 3.73(b) the electronic submission (e.g. Jane P. 5995, or through an electronic filing statement has been filed, but an Doe); or (2) signing the cover sheet using system (e.g., ETAS for trademark assignment has not been recorded is some other form of electronic signature assignment documents or EPAS or EFS discontinued. See MPEP § 1481. Section specified by the Director. See for patent assignment documents), and 3.81(c)(1) is amended to change Trademark Manual of Examining not by mail. Accordingly, the Office has ‘‘assignee(s)’’ to ‘‘assignee’’ and Procedure (TMEP) § 804.05, Signature of revised the rules to enable patent ‘‘inventor(s)’’ to ‘‘inventor’’ because the Electronically Transmitted Applications applicants to state that the assignment singular includes the plural unless the (May 2003). documents have been filed for context indicates otherwise. See 1 Section 3.31(c)(1) is revised to recordation, rather than including the U.S.C. 1. simplify the requirements for the cover assignment documents for recordation Section 5.1: Section 5.1(a) is revised sheet to only require identification of with the request. to add Mail Stop L&R to the address so whether the document to be recorded Paragraphs (a) and (b) of § 3.81 are that the address reads as follows: All relates to a governmental interest. revised to delete the reference to a correspondence in connection with this statement under § 3.73(b). If the part, including petitions, should be Paragraph (f) is added to § 3.31, and application has been assigned, the addressed to: Mail Stop L&R, provides that a trademark cover sheet assignment document should be Commissioner for Patents, P.O. Box should include the citizenship of the submitted for recording as set forth in 1450, Alexandria, Virginia 22313–1450. parties conveying and receiving the § 3.11 for the patent to issue showing National security classified applications interest, and that if the party receiving the name of the assignee. Although and other related papers may also be the interest is a partnership or joint during prosecution a statement under hand-carried to Licensing and Review, venture, the cover sheet should set forth § 3.73(b) can be relied upon to establish Technology Center 3600, as provided in the names, legal entities, and national that an assignee is of record, pursuant § 5.1(c). citizenship (or the state or country of to § 3.73(b)(1)(i), ‘‘the documents Response to Comments: The Office organization) of all general partners or submitted to establish ownership may published a notice proposing changes to active members. This information is be required to be recorded pursuant to the rules of practice regarding power of required for purposes of examination of § 3.11 in the assignment records as a attorney and assignment practice. See the application or registration file. condition to permitting the assignee to Clarification of Power of Attorney Providing this information when the take action.’’ By the time that a patent Practice, and Revisions to Assignment assignment is recorded may avoid a issues, any assignment should have Rules, 68 FR 38258 (June 27, 2003), subsequent Office action by an been submitted for recording, and 1272 Off. Gaz. Pat. Office Notices 181 examiner. reliance upon § 3.73(b) should not be (July 29, 2003). The Office received nine Section 3.34: Section 3.34(b) is necessary. Furthermore, although written comments (from one intellectual revised to delete ‘‘the originally during prosecution of an application the property organization, seven patent recorded document or’’ to thereby Office will have an opportunity to practitioners, and one business). provide that it is ‘‘a copy of the require recordation, at issuance, Comments in support of a change are document originally submitted for prosecution has come to a close and not discussed. The other comments and recording’’ that must be submitted. As there is no other practical opportunity the Office’s response to those comments explained above, the Office is revising for the Office to require recordation follow: the procedure for handling assignment before the patent is issued. Comment 1: An editorial change to documents and will no longer be Section 3.81(b) is revised to read § 1.12(b) was recommended to change returning the document that is ‘‘[a]fter payment of the issue fee: Any the term ‘‘such records and related submitted for recording. request for issuance of an application in information’’ because the use of the Section 3.41: Section 3.41(b)(2) is the name of the assignee submitted after term was confusing. revised to include electronic and the date of payment of the issue fee, and Response: The suggestion has been facsimile submission as a means in any request that a patent be corrected to adopted and ‘‘such records and related which a statement of Government state the name of the assignee, must information’’ has been changed to interest could be submitted for state that the assignment was submitted ‘‘assignment records, digests, and recordation without incurring a fee. for recordation as set forth in § 3.11 indexes’. Section 3.41(b)(2) is also revised to before issuance of the patent, and must Comment 2: The definition of ‘‘power change the cross-reference to § 3.27 include a request for a certificate of of attorney’’ in § 1.32(a) was because § 3.27 was previously revised to correction under § 1.323 of this chapter recommended to be revised to include delete § 3.27(b). (accompanied by the fee set forth in designating a patent attorney or patent

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agent or an individual authorized to Accordingly, applicants need to show proposed rule would require an practice before the Office in patent good and sufficient reasons why more applicant to choose between naming cases. Another comment noted that the than one practitioner is necessary to only a law firm by using the law firm’s use of ‘‘agent’’ in § 1.32 was confusing, represent applicants for the patent, and Customer Number, or to name ten and recommended revision to avoid such an explanation will need to be attorneys in order to name some patent using the term ‘‘agent’’ to include an provided in a petition under § 1.183 to practitioners in the law firm as well as attorney. waive the requirements of § 1.32(b)(4) others not in the law firm. The Response: These suggestions have for the applicant or the assignee of the commentators encouraged the Office to been adopted. The definition of power entire interest of the applicant to sign consider amending the rule to allow for of attorney and the remainder of the rule the power of attorney. appointment of both practitioners and have been revised accordingly. Instead Comment 4: One comment noted that Customer Numbers, as well as more of using ‘‘agent’’ the term in § 1.32(a)(3) revocation should also be than one Customer Number. The ‘‘representative’’ or ‘‘patent defined as including the situation where comments argued that using different practitioner’’ has been used. The term the power of attorney is revoked by a Customer Numbers for different ‘‘an individual authorized to practice new principal, and suggested that the combinations of in-house practitioners before the Office in patent cases’’ has definition be modified to address this and outside firm practitioners is not been included, however, because situation. Another comment suggested burdensome and risky. One comment such a person is considered to have that a new power of attorney act as a contended that all patent practitioners limited capacity to take action on behalf revocation of all prior powers of associated with a Customer Number of a patent applicant (see § 10.9(a) and attorney. needed to be at the same address. (b)), and is not recognized by the Office Response: The suggestion to expand Response: Applicants and assignees as an attorney or agent of record, and is the definition of revocation to include currently, as a matter of practice, do not entered into the Office’s computer revocation by a new or different have to choose between giving a power systems as having a power of attorney. principal has been adopted. In the of attorney to a list of individual Comment 3: The term ‘‘principal’’ in definition of revocation (§ 1.32(a)(3)), practitioners and a power of attorney to § 1.32(a)(2) was suggested as being too ‘‘by the principal’’ has been deleted the practitioners associated with a narrowly defined, and it was suggested after ‘‘previously given’’. As to the Customer Number. This is because the that the term be defined broadly enough comment that a new power of attorney Office’s computer systems only allow to include an appointment by fewer act as revocation of all prior powers of either a list of individual practitioners than all of the inventors. attorney, this suggestion has not been or a Customer Number to be entered, but Response: This suggestion has not adopted because automatic revocation not both, nor more than one Customer been adopted, but the language has been will only occur in certain situations. Number. The proposal to allow for entry clarified in regard to appointments by When an original power of attorney is of multiple Customer Numbers would fewer than all the applicants or filed giving power of attorney to likely result in separate registration assignees. Where all the applicants, or attorneys A, B, and C, and the same numbers being entered. The the assignees of the entire interest of all principal subsequently files another programming required to allow for more the applicants, do not give power of power of attorney, giving power of than one Customer Number would be attorney to the same patent attorney to D without revoking all prior very costly, and updating the list of practitioners, a petition under § 1.182 is powers of attorney, the subsequently patent practitioners would be currently required before the Office will filed power of attorney will be treated burdensome on the Office, so it has not permit the split power of attorney. See as a revocation of the original power of been adopted. MPEP § 402.10. The term ‘‘all the attorney. Similarly, if the applicant A Customer Number does not need to inventors’’ is specifically not used in signed the original power of attorney, have only patent practitioners in a order to provide for the situation where and an assignee of the entire interest of single law firm associated with it. an inventor is deceased or where a the applicant later takes action and files Instead, a Customer Number can be petition under § 1.47 has been granted a new power of attorney, the original used to list all of the patent practitioners (the applicant would then either be power of attorney is revoked and associated with a given client and who fewer than all of the inventors or the replaced by the power of attorney filed are working together to represent the party with proprietary interest pursuant by the assignee. In addition, if a power client. As a result, requiring the use of to § 1.47(b)). If the term ‘‘inventors’’ was of attorney is given to the practitioners a Customer Number if more than ten used, then in any application in which associated with a Customer Number, attorneys are to be appointed power of a petition under § 1.47 was granted, a and a (second) power of attorney is later attorney would not require an applicant petition under § 1.183 would also received giving power of attorney to to make the choice suggested by the always be required to permit the power patent practitioners associated with a comment. Furthermore, to allow any of of attorney to be signed by fewer than different Customer Number, the second the patent practitioners access to private all of the inventors, or by an assignee power of attorney will be processed, PAIR, Customer Number practice must who is the assignee of the entire interest with the first Customer Number being be used. of the applicant, but not the assignee of replaced with the second. The power of The comments have not explained the entire interest in the application attorney to the practitioners associated why appointment of more than ten (due to the lack of an assignment from with the first Customer Number is patent practitioners, particularly the inventor, or if deceased, the legal automatically revoked in this situation. hundreds of patent practitioners, is representative of the inventor, who did In all of these situations, the most necessary. When a long list of patent not sign the declaration). With a split recently filed power of attorney will practitioners is submitted to the Office, power of attorney, both patent control. this list must be constantly updated practitioners are required to sign any Comment 5: Several comments with a separate submission for each response to an Office action, and to opposed the requirement in § 1.32(b)(2) application. When a patent practitioner participate in any interviews in the to use Customer Number practice if leaves a law firm, he must file a patent application, which tends to delay more than ten patent practitioners are to withdrawal for each application in prosecution of the patent application. be named. They argued that the which he has a power of attorney. There

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could be thousands of applications in purposes so that practitioners associated § 1.32(b), the declaration would not be which he was given a power of attorney, with each of the Customer Numbers can considered defective so long as the even though he never personally signed have access to private PAIR, then requirements of § 1.63 (or § 1.64) are a single communication in any of them. applicants would need to elect a single met. If a separate paper indicating If the proper action is not taken in the Customer Number for mailing purposes, which ten registered patent attorneys or application, he or she can be held and the Office would have to reprogram registered patent agents named in the responsible for the failure to take the its system so as to be able to capture power of attorney are to be recognized appropriate action because he did not only the elected Customer Number for by the Office as being of record in the timely withdraw. Given the Office’s mailing purposes. The more Customer application or patent to which the extremely liberal policy of accepting Numbers that the applicant has power of attorney is directed is correspondence from a patent associated with a given application, the provided pursuant to § 1.32(c)(3), then practitioner who is acting in a more likely that the applicant will need the registered patent practitioners listed representative capacity pursuant to to change one or more of the Customer on the separate paper will be made of § 1.34, whether someone is of record is Numbers associated with the record. On the other hand, if the power only relevant for a patent practitioner application. If only a single Customer of attorney does not comply with signing a change of correspondence Number is used (the Office permits up § 1.32(b) and the separate paper of address, an express abandonment to three different Customer Numbers to § 1.32(c)(3) is not provided, then no without filing a continuing application, be used, one for the power of attorney, patent practitioners will be made of or a disclaimer. The work required for one for the correspondence address and record. the Office to constantly update the lists one for the fee address, but the same The Office does not encourage of patent practitioners of record in Customer Number can be used), then combined declarations and power of receipt, matching and processing of the only a single Request for Customer attorney. If such a combined format is relevant paper has not been shown to be Number Data Change can effectuate any used, however, it is recommended that justified in exchange for the value changes necessary to the list of patent the following language be inserted into actually given to applicants. practitioners, or the address associated the oath or declaration so that the patent All patent practitioners associated with a Customer Number. Given that a practitioner will be able to take with a Customer Number do not need to law firm, or a sole practitioner, can have instructions from the actual client: be at the same address. A Customer multiple Customer Numbers without the The undersigned hereby authorizes the Number can be used like a client Office being required to make any U.S. attorney or agent named herein to accept number, with all the patent practitioners programming changes, it is more and follow instructions from lll as to any who represent the client being appropriate for the patent practitioners action to be taken in the United States Patent associated with a single Customer to use multiple Customer Numbers, and Trademark Office regarding this Number. with each Customer Number for a set of application without direct communication Comment 6: Another comment asked practitioners to be associated with a set between the U.S. attorney or agent and the if more than one Customer Number of patent applications, rather than the undersigned. In the event of a change in the could be used to designate the list of persons from whom instructions may be Office to incur the cost of permitting taken, the U.S. attorney or agent named patent practitioners of record so that multiple Customer Numbers to be used herein will be so notified by the undersigned. applicants could give power of attorney for the correspondence address (private to Customer Number A (all in-house PAIR access), or for the list of patent See Responsibilities of Practitioners counsel), and Customer Number B practitioners of record in an application. Representing Clients in Proceedings (several patent practitioners who are not Comment 7: Most of the comments Before the Patent and Trademark Office, in-house counsel). Alternatively, it was opposed the proposal of denying entry 1091 Off. Gaz. Patent Office 26 (May 25, suggested that § 1.32(b)(2) be revised to of a power of attorney that was not in 1988). If the client is the company that permit the naming of more than one compliance with the proposed rules, employed the inventor, then if the Customer Number. and noted that there would be company is the assignee of the entire Response: The suggestion has not significant costs to applicants as a result interest of the applicant, the assignee been adopted. As stated in response to of this policy. For example, where the should sign the power of attorney in the comment 5, in order to implement a power of attorney was given by the patent application, not the inventor who change to permit use of more than one applicant in a combined declaration and may no longer be employed by the Customer Number to identify either the power of attorney, many comments assignee (company). Because an list of patent practitioners to be made of argued that a new declaration would be inventor who is no longer being record or the correspondence address, required to provide a proper power of employed by a company is unlikely to reprogramming of multiple Office attorney, and that a new declaration be represented by a patent practitioner computer systems would be required, would be difficult to obtain because the who has filed a patent application on which is an automation project that the applicant may no longer be employed behalf of the assignee, the fact that it Office does not have resources to devote by the company. Several comments would be difficult to obtain the to at this time. Furthermore, the Office emphasized the burden to applicants in signature of the inventor on a new could not reprogram the software to changing their forms to comply with the power of attorney is not persuasive, and allow multiple Customer Numbers to be limit of ten patent practitioners of a petition under § 1.183 to waive this used for the list of patent practitioners record and requested a several-year provision of the rules is unlikely to be without also allowing multiple delay in the effective date. granted for such a reason. An inventor Customer Numbers being used for the Response: After careful consideration, may be available to sign a power of correspondence address because access the Office has decided to permit attorney, but may have a divergent to private PAIR is a function of the applicants to supply a separate paper interest from the company. Where the correspondence address being listing the patent practitioners who shall company (assignee) has not chosen to associated with a single Customer be made of record. Where a power of intervene in the application, and the Number. Thus, if the Office were to attorney is included as part of a power of attorney is given by the allow more than one Customer Number declaration pursuant to § 1.63, and the inventor (applicant), the inventor may to be given for correspondence address power of attorney does not comply with later revoke the original power of

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attorney to the patent practitioners attorney takes over prosecution of a of attorney practice to add new patent chosen by the assignee and appoint his/ patent application from a former practitioners would encourage her own patent attorney and change the counsel, an associate power of attorney practitioners to give an associate power correspondence address in the is useful to bridge the gap until a new of attorney rather than having a new application (or patent). Such an exercise power of attorney can be executed. In power of attorney to the practitioners of authority by an inventor (applicant) addition, an associate power of attorney associated with a Customer Number is appropriate so long as the assignee of is considered useful where a patent signed by the applicant or assignee of the entire interest of the applicant has practitioner of record who is not in the the entire interest of the applicant, even not appointed a power of attorney, but Washington, DC, area appoints another though the new power of attorney to the adds unnecessary complexity to the patent practitioner within the area to practitioners associated with a Customer prosecution of the application. assist in the prosecution for the purpose Number would enhance their ability to Where a power of attorney lists more of some procedural or petition matter, represent the applicant or assignee of than ten patent practitioners and the but does not wish to have the the entire interest of the applicant Office enters those patent practitioners practitioner made of record in all patent because of the access to private PAIR listed on a separate paper provided applications (as would happen if they gained by Customer Number practice. pursuant to § 1.32(c)(3), a patent used Customer Number practice, and Using a Customer Number effectively practitioner who is not recognized as added the practitioner to the list of as a client number, so that both in-house the patent attorney or patent agent of practitioners associated with the patent counsel and other patent record and, as a result is not entered Customer Number). Another comment practitioners are associated with the into the Office’s computer systems, is argued that the associate power of Customer Number, may only be not required to request to be withdrawn, attorney practice was desirable because appropriate for clients who file many if the practitioner ceases to represent the of the delays in obtaining a new power patent applications. If the set of applicant or assignee of the applicant. If of attorney, and that such delays would practitioners who are representing a such a patent practitioner files a request lead to the original attorney of record client on a matter is so unique that it is to withdraw, the Office will enter the receiving correspondence for too long. not efficient to establish a Customer paper in the patent application file, but Another comment suggested that the Number specifically for this set of will not process the paper, as the rules be amended to provide that an practitioners, then the power of attorney practitioner cannot be withdrawn associate attorney’s authority is not would be to a list of patent practitioners because the practitioner was not made dependent upon the continued and the correspondence address could of record and was not entered into the representation by the appointing be given as a Customer Number so that Office’s computer records. principal attorney. only those patent practitioners Comment 8: One comment, while questioning the wisdom of having any Response: Associate power of attorney associated with the Customer Number limit on the number of patent practice has been eliminated because for the correspondence address (a subset practitioners who may be given a power the practice is unnecessary in view of of those with power of attorney) would of attorney, suggested a limit of 25, and Customer Number practice. Customer have access to private PAIR. for the Office to enter in the first 25 Number practice, like an associate As to the suggestion that an associate when more than 25 are listed in a power power of attorney, allows the list of power of attorney is necessary for the of attorney. Alternatively, it was patent practitioners to be changed easily attorney to conduct an interview, e.g., in suggested in two comments that a fee be to add an attorney without execution of the situation where a non-Washington, required for the entry of more than 10 a new power of attorney from the client, DC, firm appoints a Washington, DC, patent practitioners. Another comment and therefore it is not necessary to be area patent practitioner to conduct an questioned the limit contending that able to give an associate power of interview in a patent application, it is where an application is electronically attorney if the power of attorney is to noted that the Washington, DC, patent filed, the Office does not have to enter the practitioners associated with a practitioner does not need to be of in any lists of registration numbers, Customer Number. Instead of using an record or have an associate power of because if PrintEFS were updated, the associate power of attorney, if the power attorney if the Washington, DC, application data sheet could be scanned of attorney is to the patent practitioners practitioner has in their possession a and optical character recognition (OCR) associated with a Customer Number, a copy of the application file. Even if the be used to upload the data. Request for Customer Number Data Washington, DC, practitioner does not Response: A smaller number would Change can be filed to add a practitioner have a copy of the application file, the be preferred by some, a larger by others, that would have been given an associate practitioner may conduct an interview but the Office has decided that ten best power. In order to most effectively with ‘‘proper authority from the balances the need of applicants to represent a patent applicant, a patent applicant or attorney or agent of record appoint several practitioners without practitioner needs access to the private in the form of a paper on file in the using Customer Number practice and Patent Application Information application.’’ See MPEP § 713.05. the need of the Office to avoid Retrieval (private PAIR) system. Private Should an examiner object to a unnecessary work. The suggestion to PAIR enables the practitioner to obtain practitioner who is not of record adopt a fee to accept more than a set direct access the Office’s electronic conducting the interview, the number of patent practitioners of record records for a patent application, practitioner is encouraged to bring a is noted and may be pursued in a future including in many instances images of letter signed by an attorney of record, rule making, but the extra burden the papers in the patent application. In authorizing the practitioner to conduct associated with entering additional order to obtain access to these records, the interview. For example, a sample of names was a significant factor for not however, a Customer Number must be an ‘‘Authorization to Act in a adopting the suggestions at this time. associated with the correspondence Representative Capacity’’ is posted on Comment 9: Many comments address of the application, and the the Office’s Internet Web site under disapproved of the deletion of associate registered practitioner must be ‘‘Forms’’ at http://www.uspto.gov/web/ power of attorney practice. The associated with the Customer Number. forms/sb0084.pdf. A faxed copy of the comments argued that when a new The availability of the associate power letter would be acceptable.

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Similarly, a patent practitioner does information, but is only available for attorney, the original attorney can not need to be of record to file a reply applications that have either published withdraw, or simply change the to an Office action. See § 1.34, and or issued as patents. If the patent correspondence address to the new MPEP §§ 405 and 714.01(c). Although practitioner merely has an associate attorney’s address. the practitioner who is acting in a power of attorney, the practitioner is not Comment 10: One comment explained representative capacity pursuant to associated with the Customer Number, that the list of practitioners associated § 1.34 cannot sign a change of and is not able to access Private PAIR. with a Customer Number usually only correspondence address (§ 1.33(a)(2)), a Without access to private PAIR, a patent includes the partners in a firm, whereas disclaimer (§ 1.321), or a request to practitioner may not have access to the an associate power of attorney was expressly abandon a patent application complete patent application file and given to associate attorneys. The (§ 1.138) (unless also filing a continuing cannot fully represent the client. For comment argued that eliminating application), he can take all other example, patent term adjustment associate power of attorney practice actions necessary to continue the calculations are available in private would hamper development of associate prosecution of the application. An PAIR, but are not mailed to applicants. attorneys. associate power of attorney does not put Currently, the Office records both Response: The Office’s computer a patent practitioner in a significantly primary attorneys of record (who may system does not allow both a power of better position to represent an applicant not be associated with a Customer attorney to the practitioners associated than they could exercise by acting in a Number) as well as associate powers of with a Customer Number and either a representative capacity pursuant to attorney in the Office’s PreExam list of patent practitioners (without use § 1.34. An associate power of attorney computer system, so as to have a readily of a Customer Number) or another list does, however, increase the workload of available list of patent practitioners of of practitioners associated with a the Office as the Office practice was to record for a particular application. Since different Customer Number. enter the associate patent attorneys or an associate power of attorney Accordingly, the Office cannot enter a patent agents into the Office computer terminates with the termination of the power of attorney to a Customer records, indicate that the practitioner is power of attorney to the patent Number and an associate power of an associate attorney, and then change practitioner who gave the associate attorney. Furthermore, the relationship the listing if the primary attorney ceased power of attorney, associate powers of between being of record in a patent to have a power of attorney, or as new attorney require record keeping in application (as would have occurred associates were appointed. In order to addition to the entry of the associate where the Office was able to enter an reduce the paperwork that the Office powers of attorney into attorney of associate power of attorney), and being needs to process for a patent record fields, because the Office must able to develop as a patent practitioner is not understood. A patent practitioner application, the Office will no longer take down the associate power of who is an associate at a firm could act enter associate powers of attorney into attorney once the primary attorney no in a representative capacity pursuant to the electronic records for patent longer has power of attorney. The § 1.34, under the direction of a applications so as to make the associate suggestion to allow an associate power practitioner of record. The inability to attorney of record. of attorney to remain valid even after the power of attorney to the primary sign a change of correspondence Patent practitioners with an associate attorney has been revoked, or where the address, has little to do with power of attorney cannot directly access primary attorney has withdrawn, has professional development. private PAIR, and as a result, are less not been adopted. If an applicant or Comment 11: Many comments able to represent a client than one with assignee desires the associate to be an suggested that a benefit of associate direct access to private PAIR. Private attorney of record, the applicant or power of attorney practice is to permit PAIR allows access to the Office’s assignee should sign the required power someone who is not of record to computer records for the patent of attorney. conduct an interview, and that many application, for example to the Patent In the situation where a practitioner is examiners deny such an interview Application Locating and Monitoring being brought in to assist with some because the attorney is not of record, (PALM) system contents, to the patent overflow work, no appointment of an even though the Manual of Patent term adjustment calculations, and, if the associate power of attorney is necessary Examining Procedure states that such an application is maintained in the Image before the Office is willing to accept the interview is acceptable. File Wrapper (IFW) system, to the image paper from the practitioner. Part 1 of the Response: Applicants desiring to have filed of the documents in the file rules of practice do not address an attorney who is not of record and are history. One particularly helpful feature engagement letters between one patent concerned that the examiner may of private PAIR is the ‘‘View Outgoing practitioner and another. As a result, if question the authority of the Correspondence,’’ a feature that allows the attorney of record desires the practitioner to conduct the interview patent practitioners to obtain a list of assistance of another patent practitioner, should delegate to the practitioner the applications with recently mailed the rules of practice do not prohibit the authority to conduct the interview by a correspondence, and, if the application patent practitioner from obtaining an separate letter, such as an is maintained in the IFW system, to ‘‘Associate Power of Attorney’’ or ‘‘Authorization to Act in a view the documents. To have access to ‘‘Authorization of Agent’’ from the Representative Capacity.’’ This sample private PAIR for a patent application, patent practitioner of record for their template is available on the Office’s the patent practitioner must be records. Furthermore, such a document Internet Web site in the listing of forms associated with a Customer Number that would be considered a showing under after PTO/SB/83. A faxed copy of such is associated with the correspondence § 1.34 that a person was acting in a a letter would be acceptable, and the address for the application. In addition, representative capacity pursuant to practitioner could bring a copy of the the patent practitioner’s computer § 1.34 on behalf of the applicant. letter to the interview in the event that system (or his or her paralegal’s As to the delay inherent in obtaining the examiner has a question about the computer system) must be loaded with a new power of attorney, although the authority of the practitioner. the appropriate software. Public PAIR original attorney will no longer be Comment 12: One comment noted also allows access to much of this same permitted to give an associate power of that having applicant execute a new

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power of attorney would not be unduly inventors, or fewer than the assignee of docket numbers if the assignment is for burdensome, but requested clarification the entire interest of the applicant. more than one patent or trademark. of the effect of elimination of associate Response: The suggestion has not Comment 18: Another comment power of attorney practice upon been adopted. The current practice is to stated that sometimes the wrong patent previously filed associate powers of permit revocation by fewer than all of assignment document is attached to the attorney. the applicants only if a petition under Notice of Recordation, and having a Response: Previously filed associate § 1.182 is filed, explaining why a split copy of the document has been useful powers of attorney remain valid, and power of attorney is necessary. See in the past to enable the mix-up to be will continue to be effective. MPEP § 402.10. Having more than one addressed. Comment 13: One comment noted a attorney or an attorney and an applicant Response: The Office has made patent discomfort with the use of Customer required to sign all correspondence in and trademark assignment records Number practice in that if the Office an application often leads to the available over the Internet. Although the transposes digits when entering the application becoming abandoned due to copy of a patent assignment document Customer Number, the correspondence the difficulty in obtaining the necessary cannot be displayed using http:// goes to an entirely incorrect address. signatures. As a result, the rules have assignments.uspto.gov/assignments/ Response: The Office is sensitive to not been amended to provide for fewer q?db=pat, the assignment records on the the need to carefully check for the than all of the applicants to be able to Internet provide a mechanism to check correct entry of Customer Numbers and revoke the power of attorney without a if the patent assignment was recorded is taking steps to ensure that the correct showing of sufficient cause. correctly. Customer Number is entered. For Administrative Procedure Act: This Comment 16: One comment suggested example, when the Office keys in a final rule changes the rules of practice that .jpg files be added to the list of Customer Number, the address to Office procedures involving power of formats accepted for electronic associated with the Customer Number is attorney practice and recording of submission of assignment documents retrieved. This address is compared to assignment documents. The changes pursuant to § 3.24 and § 3.25, arguing the name of the firm or company that addressed in this final rule are limited that this format is accepted in filed the patent application, and any to the format for and the manner of Trademarks. street address included with the submitting, establishing and changing application papers, to check the Response: At this time it is not the power of attorney, for submitting accuracy of the Customer Number that feasible for the Office to expand the documents to be recorded in the is entered. Applicants can assist the formats that will be accepted for assignment records, and the availability Office in improving the accuracy of electronic submission of assignment of assignment records to the public. entry of the Customer Number by documents. The format .jpg is Therefore, these changes involve rules ensuring that the Customer Number is acceptable for Trademark documents of agency practice and procedure under clear and legible (e.g., at least 12- or 14- filed through Trademark Electronic 5 U.S.C. 553(b)(A). See Bachow point font and not fuzzy). Application System (TEAS), but not Communications Inc. v. FCC, 237 F.3d Comment 14: One comment stated assignments of Trademarks filed 683, 690 (DC Cir. 2001). Therefore, prior that the proposal to require the exact through ETAS. notice and opportunity for public name as registered with his or her Comment 17: Two comments noted comment were not required pursuant to signature was unreasonable, but noted the change in practice proposed in 5 U.S.C. 553(b) or (c) (or any other law). that it was not clear that the exact name § 3.34 would be more acceptable to Nevertheless, the Office did provide an as registered was in fact being proposed applicants if the Notice of Recordation opportunity for public comment on the to be required. were modified to also include an changes in the notice of proposed rule Response: The Office did intend to Attorney Docket Number, as well as the making because the Office desires the propose to require the exact name as title of the invention according to the benefit of public comment on the registered, as this change was also application on filing. Alternatively, one proposed changes. included in the rule changes proposed comment suggested use of the Express Regulatory Flexibility Act: As prior in a recent notice of proposed rule Mail number as an identifier on the notice and an opportunity for public making. See Changes To Support Notice of Recordation. comment were not required pursuant to Implementation of the United States Response: The proposal to use the 5 U.S.C. 553 (or any other law), a Patent and Trademark Office 21st Express Mail number as an identifier is regulatory flexibility analysis under the Century Strategic Plan, 68 FR 53816 not adopted. The Office can process Regulatory Flexibility Act (5 U.S.C. 601 (Sep. 12, 2003), 1275 Off. Gaz. Pat. faxed or electronically filed assignment et seq.) is not required. See 5 U.S.C. 603. Office Notices (Oct. 7, 2003) (proposed documents much quicker than those The changes in this final rule impose no rule). On reflection, the Office agrees received by mail, and allowing use of an additional fees on patent applicants. that it is not necessary to obtain the Express Mail number would promote a Executive Order 13132: This rule exact name as registered to confirm the practice of mailing at a time when the making does not contain policies with identity of the person signing the Office is seeking to discourage mailing federalism implications sufficient to correspondence, but will instead require and encourage electronic submissions. warrant preparation of a Federalism the typed name of the person signing The Office has, however, adopted the Assessment under Executive Order the correspondence. Signatures are not suggestion to include the title of the 13132 (Aug. 4, 1999). always legible, and digits on registration invention, but notes that the title that Executive Order 12866: This rule numbers are sometimes transposed or will be printed on the Notice of making has been determined to be not inadvertently omitted. Accordingly, Recordation is the title reflected in the significant for purposes of Executive having a typed name is considered Office’s computer records, and will not Order 12866 (Sept. 30, 1993). necessary. be rekeyed from the assignment. As to Paperwork Reduction Act: This final Comment 15: As to § 1.36, one the attorney docket number, the rule involves information collection comment stated that the revocation of suggestion has also been adopted, if the requirements which are subject to the power of attorney should be assignment is for a single property. The review by the Office of Management and available to fewer than all of the notice of recordation cannot reflect Budget (OMB) under the Paperwork

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Reduction Act of 1995 (44 U.S.C. 3501 Estimated Total Annual Burden foreign filing licenses in certain et seq.). The collections of information Hours: 120,173 hours. circumstances to applicants filing patent involved in this final rule have been Needs and Uses: The Office records applications in foreign countries. This reviewed and previously approved by over 200,000 assignments or documents collection is used by the public to OMB under OMB control numbers related to ownership of patent and petition the USPTO to allow disclosure, 0651–0027, 0651–0032, 0651–0034, and trademark cases each year. The Office modification, or rescission of a secrecy 0651–0035. The changes in this final requires a cover sheet to expedite the order, or to obtain a general or group rule do not affect the information processing of these documents and to permit. Applicants may also petition the requirements associated with these ensure that they are properly recorded. USPTO for a foreign filing license, a information collections. Therefore, the OMB Number: 0651–0032. retroactive license, or to change the Office is not submitting these Title: Initial Patent Application. scope of a license. information collection packages to OMB Form Number: PTO/SB/01–07, PTO/ OMB Number: 0651–0035. for review and approval. SB/13PCT, PTO/SB/16–19, PTO/SB/29 Title: Representative and Address The title, description and respondent and 29A, PTO/SB/101–110. Provisions. description of each of the information Type of Review: Approved through Form Numbers: PTO/SB/80/81/82/83/ collections are shown below with an July of 2006. 122/123/124A/124B/125A/125B. estimate of the annual reporting Affected Public: Individuals or Type of Review: Approved through burdens. Included in the estimate is the households, business or other for-profit November of 2005. Affected Public: Individuals or time for reviewing instructions, institutions, not-for-profit institutions, households, business or other for-profit, gathering and maintaining the data farms, Federal Government, and State, not for-profit institutions and Federal needed, and completing and reviewing local, or tribal governments. Government. the collection of information. The Estimated Number of Respondents: principal impacts of the changes in this Estimated Number of Respondents: 454,287. 355,005. proposed rule are to: (1) Provide for Estimated Time Per Response: 22 power of attorney to a Customer Estimated Time Per Response: 3 minutes to 10 hours and 45 minutes. minutes (0.05 hours) to 1 hour 30 Number and to limit the number of Estimated Total Annual Burden attorneys who may be given a power of minutes (1.5 hours). Hours: 4,171,568 hours. Estimated Total Annual Burden attorney without using a Customer Needs and Uses: The purpose of this Number; (2) eliminate associate power Hours: 30,088 hours. information collection is to permit the Needs and Uses: Under 35 U.S.C. 2 of attorney practice; (3) require Office to determine whether an and 37 CFR 1.31–1.36 and 1.363, this attorneys acting in a representative application meets the criteria set forth information is used to submit a request capacity to specify their name and in the patent statute and regulations. to grant or revoke power of attorney in registration number; (4) allow access to The standard Fee Transmittal form, New an application or patent, to withdraw as assignment records except those relating Utility Patent Application Transmittal patent attorney or patent agent of to any pending or abandoned patent form, New Design Patent Application record, or to designate or change the application which is preserved in Transmittal form, New Plant Patent correspondence address for one or more confidence under § 1.14; (5) provide that Application Transmittal form, applications or patents, and to request assignment documents submitted for Declaration, Provisional Application or change information associated with a recording must be on certain sizes of Cover Sheet, and Plant Patent customer number. paper; (6) specifically state that the Application Declaration will assist Interested persons are requested to assignment documents that are applicants in complying with the send comments regarding these submitted for recording will not be requirements of the patent statute and information collections, including returned; (7) for assignments that are regulations, and will further assist the suggestions for reducing this burden, to submitted electronically, provide for an USPTO in processing and examination Robert J. Spar, Director, Office of Patent electronic signature; (8) require the of the application. Legal Administration, Commissioner for citizenship of the parties conveying and OMB Number: 0651–0034. Patents, P.O. Box 1450, Alexandria, VA receiving the interest on a trademark Title: Secrecy and License to Export. 22313–1450, or to the Office of assignment cover sheet; (9) provide that Form Numbers: None. Information and Regulatory Affairs, a request to issue a patent to an assignee Type of Review: Approved through OMB, 725 17th Street, NW., filed after issue fee payment must be April of 2004. Washington, DC 20503, (Attn: USPTO accompanied by a request for a Affected Public: Individuals or Desk Officer). certificate of correction; and (10) change households, business or other for-profit Notwithstanding any other provision the address that would be used for institutions, not-for-profit institutions, of law, no person is required to respond mailing certain patent applications. to nor shall a person be subject to a OMB Number: 0651–0027. farms, Federal Government, and State, local, or tribal governments. penalty for failure to comply with a Title: Recording Assignments. collection of information subject to the Form Numbers: PTO–1594 and PTO– Number of Respondents: 1,669. Estimated Time Per Response: requirements of the Paperwork 1595. Reduction Act unless that collection of Type of Review: Approved through Between 30 minutes and 4 hours. information displays a currently valid June of 2005. Estimated Total Annual Burden Affected Public: Individuals or Hours: 1,310 hours. OMB control number. households, business or other for-profit Needs and Uses: When disclosure of List of Subjects institutions, not-for-profit institutions, an invention may be detrimental to 37 CFR Part 1 farms, Federal Government, and State, national security, the Director of the local, or tribal governments. USPTO must issue a secrecy order and Administrative practice and Estimated Number of Respondents: withhold the publication of the procedure, Courts, Freedom of 240,345. application or grant of a patent for such Information, Inventions and patents, Estimated Time Per Response: 30 period as the national interest requires. Reporting and record keeping minutes. The USPTO is also required to grant requirements, Small Businesses.

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37 CFR Part 3 § 1.31 Applicants may be represented by a § 10.6 of this subchapter) (patent registered patent attorney or patent agent. Administrative practice and practitioners). Except as provided in An applicant for patent may file and procedure, Inventions and patents, paragraph (c)(1) or (c)(2) of this section, prosecute his or her own case, or he or Reporting and record keeping the Office will not recognize more than she may give a power of attorney so as requirements. ten patent practitioners as being of to be represented by a registered patent record in an application or patent. If a 37 CFR Part 5 attorney or registered patent agent. See power of attorney names more than ten Classified information, foreign § 10.6 of this subchapter. The United patent practitioners, such power of relations, inventions and patents. States Patent and Trademark Office attorney must be accompanied by a cannot aid in the selection of a separate paper indicating which ten I For the reasons set forth in the registered patent attorney or patent patent practitioners named in the power preamble, 37 CFR parts 1, 3 and 5 are agent. of attorney are to be recognized by the amended as follows: I 5. Add new § 1.32 to read as follows: Office as being of record in application or patent to which the power of attorney PART 1—RULES OF PRACTICE IN § 1.32 Power of attorney. is directed. PATENT CASES (a) Definitions. I 6. Amend § 1.33 by revising I (1) Power of attorney means a written 1. The authority citation for 37 CFR paragraphs (a) introductory text, (b) part 1 continues to read as follows: document by which a principal designates a registered patent attorney introductory text, (b)(1), (b)(2) and (c) to Authority: 35 U.S.C. 2(b)(2). or a registered patent agent to act on his read as follows: or her behalf. I 2. Amend § 1.1 by revising paragraph § 1.33 Correspondence respecting patent (a)(4)(i) to read as follows, and by (2) Principal means either an applications, reexamination proceedings, removing and reserving paragraph (f). applicant for patent (§ 1.41(b)) or an and other proceedings. assignee of entire interest of the § 1.1 Addresses for non-trademark applicant. The principal executes a (a) Correspondence address and correspondence with the United States power of attorney designating one or daytime telephone number. When filing Patent and Trademark Office. more registered patent attorneys or an application, a correspondence (a) * * * registered patent agents to act on his or address must be set forth in either an (4) Office of Public Records her behalf. application data sheet (§ 1.76), or correspondence. (i) Assignments. All (3) Revocation means the cancellation elsewhere, in a clearly identifiable patent-related documents submitted by by the principal of the authority manner, in any paper submitted with an mail to be recorded by Assignment previously given to a registered patent application filing. If no correspondence Services Division, except for documents attorney or registered patent agent to act address is specified, the Office may treat filed together with a new application, on his or her behalf. the mailing address of the first named should be addressed to: Mail Stop (4) Customer Number means a inventor (if provided, see §§ 1.76(b)(1) Assignment Recordation Services, number that may be used to: and 1.63(c)(2)) as the correspondence Director of the United States Patent and (i) Designate the correspondence address. The Office will direct all Trademark Office, P.O. Box 1450, address of a patent application or patent notices, official letters, and other Alexandria, Virginia 22313–1450. See such that the correspondence address communications relating to the § 3.27. for the patent application or patent application to the correspondence * * * * * would be the address associated with address. The Office will not engage in (f) [Reserved] the Customer Number; double correspondence with an (ii) Designate the fee address (§ 1.363) applicant and a registered patent I 3. Revise § 1.12(b) to read as follows: of a patent such that the fee address for attorney or patent agent, or with more § 1.12 Assignment records open to public the patent would be the address than one registered patent attorney or inspection. associated with the Customer Number; patent agent except as deemed * * * * * and necessary by the Director. If more than (b) Assignment records, digests, and (iii) Submit a list of practitioners such one correspondence address is specified indexes relating to any pending or that those registered patent practitioners in a single document, the Office will abandoned patent application, which is associated with the Customer Number establish one as the correspondence open to the public pursuant to § 1.11 or would have power of attorney. address and will use the address for which copies or access may be (b) A power of attorney must: associated with a Customer Number, if supplied pursuant to § 1.14, are (1) Be in writing; given, over a typed correspondence available to the public. Copies of any (2) Name one or more representatives address. For the party to whom assignment records, digests, and indexes in compliance with (c) of this section; correspondence is to be addressed, a that are not available to the public shall (3) Give the representative power to daytime telephone number should be be obtainable only upon written act on behalf of the principal; and supplied in a clearly identifiable authority of the applicant or applicant’s (4) Be signed by the applicant for manner and may be changed by any assignee or patent attorney or patent patent (§ 1.41(b)) or the assignee of the party who may change the agent or upon a showing that the person entire interest of the applicant. correspondence address. The (c) A power of attorney may only seeking such information is a bona fide correspondence address may be name as representative: prospective or actual purchaser, changed as follows: (1) One or more joint inventors mortgagee, or licensee of such (§ 1.45); * * * * * application, unless it shall be necessary (2) Those registered patent (b) Amendments and other papers. to the proper conduct of business before practitioners associated with a Customer Amendments and other papers, except the Office or as provided in this part. Number; for written assertions pursuant to * * * * * (3) Ten or fewer registered patent § 1.27(c)(2)(ii) of this part, filed in the I 4. Revise § 1.31 to read as follows: attorneys or registered patent agents (see application must be signed by:

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(1) A registered patent attorney or § 1.36 Revocation of power of attorney; I 10. Revise § 1.363 by adding paragraph patent agent of record appointed in withdrawal of patent attorney or patent (c) as follows: compliance with § 1.32(b); agent. (a) A power of attorney, pursuant to § 1.363 Fee address for maintenance fee (2) A registered patent attorney or purposes. patent agent not of record who acts in § 1.32(b), may be revoked at any stage in the proceedings of a case by an * * * * * a representative capacity under the (c) A fee address must be an address provisions of § 1.34; applicant for patent (§ 1.41(b)) or an assignee of the entire interest of the associated with a Customer Number. * * * * * applicant. A power of attorney to the PART 3—ASSIGNMENT, RECORDING (c) All notices, official letters, and patent practitioners associated with a AND RIGHTS OF ASSIGNEE other communications for the patent Customer Number will be treated as a owner or owners in a reexamination request to revoke any powers of attorney I 11. The authority citation for 37 CFR proceeding will be directed to the patent previously given. Fewer than all of the part 3 continues to read as follows: applicants (or by fewer than the attorney or patent agent of record (see Authority: 15 U.S.C. 1123; 35 U.S.C. § 1.32(b)) in the patent file at the assignee of the entire interest of the 2(b)(2). address listed on the register of patent applicant) may only revoke the power of attorneys and patent agents maintained attorney upon a showing of sufficient I 12. Revise § 3.1 to read as follows: cause, and payment of the petition fee pursuant to § 10.5 and § 10.11 or, if no § 3.1 Definitions. patent attorney or patent agent is of set forth in § 1.17(h). A registered patent For purposes of this part, the record, to the patent owner or owners at attorney or patent agent will be notified following definitions shall apply: the address or addresses of record. of the revocation of the power of attorney. Where power of attorney is Application means a national Amendments and other papers filed in application for patent, an international a reexamination proceeding on behalf of given to the patent practitioners associated with a Customer Number patent application that designates the the patent owner must be signed by the United States of America, or an patent owner, or if there is more than (§ 1.32(c)(2)), the practitioners so appointed will also be notified of the application to register a trademark one owner by all the owners, or by a under section 1 or 44 of the Trademark patent attorney or patent agent of record revocation of the power of attorney when the power of attorney to all of the Act, 15 U.S.C. 1051 or 15 U.S.C. 1126, in the patent file, or by a registered unless otherwise indicated. patent attorney or patent agent not of practitioners associated with the Customer Number is revoked. The Assignment means a transfer by a record who acts in a representative party of all or part of its right, title and capacity under the provisions of § 1.34. notice of revocation will be mailed to the correspondence address for the interest in a patent, patent application, Double correspondence with the patent registered mark or a mark for which an owner or owners and the patent owner’s application (§ 1.33) in effect before the revocation. An assignment will not of application to register has been filed. patent attorney or patent agent, or with Document means a document which a more than one patent attorney or patent itself operate as a revocation of a power previously given, but the assignee of the party requests to be recorded in the agent, will not be undertaken. If more Office pursuant to § 3.11 and which than one patent attorney or patent agent entire interest of the applicant may revoke previous powers of attorney and affects some interest in an application, is of record and a correspondence give another power of attorney of the patent, or registration. address has not been specified, Office means the United States Patent assignee’s own selection as provided in correspondence will be held with the and Trademark Office. § 1.32(b). last patent attorney or patent agent Recorded document means a made of record. (b) A registered patent attorney or document which has been recorded in patent agent who has been given a * * * * * the Office pursuant to § 3.11. power of attorney pursuant to § 1.32(b) Registration means a trademark I 7. Revise § 1.34 to read as follows: may withdraw as attorney or agent of registration issued by the Office. record upon application to and approval I 13. Revise § 3.21 to read as follows: § 1.34 Acting in a representative capacity. by the Director. The applicant or patent When a registered patent attorney or owner will be notified of the withdrawal § 3.21 Identification of patents and patent applications. patent agent acting in a representative of the registered patent attorney or capacity appears in person or signs a patent agent. Where power of attorney is An assignment relating to a patent paper in practice before the United given to the patent practitioners must identify the patent by the patent States Patent and Trademark Office in a associated with a Customer Number, a number. An assignment relating to a request to delete all of the patent patent case, his or her personal national patent application must practitioners associated with the appearance or signature shall constitute identify the national patent application Customer Number may not be granted if a representation to the United States by the application number (consisting of an applicant has given power of Patent and Trademark Office that under the series code and the serial number, attorney to the patent practitioners the provisions of this subchapter and e.g., 07/123,456). An assignment associated with the Customer Number the law, he or she is authorized to relating to an international patent in an application that has an Office represent the particular party in whose application which designates the United action to which a reply is due, but behalf he or she acts. In filing such a States of America must identify the insufficient time remains for the paper, the registered patent attorney or international application by the applicant to file a reply. See § 1.613(d) patent agent must specify his or her international application number (e.g., for withdrawal in an interference. registration number and name with his PCT/US90/01234). If an assignment of a patent application filed under § 1.53(b) or her signature. Further proof of § 1.53 [Amended] is executed concurrently with, or authority to act in a representative I 9. Amend § 1.53 by removing subsequent to, the execution of the capacity may be required. paragraph (d)(9) and redesignating patent application, but before the patent I 8. Revise § 1.36 to read as follows: paragraph (d)(10) as paragraph (d)(9). application is filed, it must identify the

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patent application by the name of each form as prescribed by the Director. I 18. Revise § 3.34 to read as follows: inventor and the title of the invention so When printed to a paper size of either § 3.34 Correction of cover sheet errors. that there can be no mistake as to the 21.6 by 27.9 cm (81⁄2 by 11 inches) or patent application intended. If an 21.0 by 29.7 cm (DIN size A4), a 2.5 cm (a) An error in a cover sheet recorded assignment of a provisional application (one-inch) margin must be present on all pursuant to § 3.11 will be corrected only under § 1.53(c) is executed before the sides. if: provisional application is filed, it must (2) For paper or facsimile (1) The error is apparent when the identify the provisional application by submissions: All documents should be cover sheet is compared with the the name of each inventor and the title submitted on white and non-shiny recorded document to which it pertains, of the invention so that there can be no paper that is either 81⁄2 by 11 inches and mistake as to the provisional application (21.6 by 27.9 cm) or DIN size A4 (21.0 (2) A corrected cover sheet is filed for intended. by 29.7 cm) with a one-inch (2.5 cm) recordation. I 14. Revise § 3.24 to read as follows: margin on all sides in either case. Only (b) The corrected cover sheet must be one side of each page may be used. The accompanied by a copy of the document § 3.24 Requirements for documents and Office will not return recorded originally submitted for recording and cover sheets relating to patents and patent documents, so original documents applications. by the recording fee as set forth in should not be submitted for recording. (a) For electronic submissions: Either § 3.41. I 16. Revise § 3.27 to read as follows: a copy of the original document or an I 19. Revise § 3.41(b)(2) to read as extract of the original document may be § 3.27 Mailing address for submitting follows: submitted for recording. All documents documents to be recorded. § 3.41 Recording fees. must be submitted as digitized images Documents and cover sheets * * * * * in Tagged Image File Format (TIFF) or submitted by mail for recordation another form as prescribed by the should be addressed to Mail Stop (b) * * * Director. When printed to a paper size Assignment Recordation Services, (2) The document and cover sheet are of either 21.6 by 27.9 cm (81⁄2 by 11 Director of the United States Patent and either: Faxed or electronically submitted inches) or 21.0 by 29.7 cm (DIN size Trademark Office, P.O. Box 1450, as prescribed by the Director, or mailed A4), the document must be legible and Alexandria, Virginia 22313–1450, to the Office in compliance with § 3.27. a 2.5 cm (one-inch) margin must be unless they are filed together with new I 20. Revise § 3.81 to read as follows: present on all sides. applications. § 3.81 Issue of patent to assignee. (b) For paper or facsimile I 17. Amend § 3.31 by revising submissions: Either a copy of the paragraphs (a)(7) and (c)(1) and adding a (a) With payment of the issue fee: An original document or an extract of the paragraph (f) to read as follows: application may issue in the name of the original document must be submitted assignee consistent with the for recording. Only one side of each § 3.31 Cover sheet content. application’s assignment where a page may be used. The paper size must (a) * * * request for such issuance is submitted be either 21.6 by 27.9 cm (81⁄2 by 11 (7) The signature of the party with payment of the issue fee, provided inches) or 21.0 by 29.7 cm (DIN size submitting the document. For an the assignment has been previously A4), and in either case, a 2.5 cm (one- assignment document or name change recorded in the Office. If the assignment inch) margin must be present on all filed electronically, the person who has not been previously recorded, the sides. For paper submissions, the paper signs the cover sheet must either: request must state that the document used should be flexible, strong white, (i) Place a symbol comprised of has been filed for recordation as set non-shiny, and durable. The Office will letters, numbers, and/or punctuation forth in § 3.11. not return recorded documents, so marks between forward slash marks (b) After payment of the issue fee: Any original documents must not be submission (e.g./Thomas O’Malley III/) request for issuance of an application in submitted for recording. in the signature block on the electronic the name of the assignee submitted after I 15. Revise § 3.25 to read as follows: submission; or the date of payment of the issue fee, and (ii) Sign the cover sheet using some any request for a patent to be corrected § 3.25 Recording requirements for other form of electronic signature trademark applications and registrations. to state the name of the assignee, must specified by the Director. state that the assignment was submitted (a) Documents affecting title. To for recordation as set forth in § 3.11 record documents affecting title to a * * * * * before issuance of the patent, and must trademark application or registration, a (c) * * * (1) Indicate that the document relates include a request for a certificate of legible cover sheet (see § 3.31) and one to a Government interest; and correction under § 1.323 of this chapter of the following must be submitted: (1) A copy of the original document; * * * * * (accompanied by the fee set forth in (2) A copy of an extract from the (f) Each trademark cover sheet should § 1.20(a)) and the processing fee set document evidencing the effect on title; include the citizenship of the party forth in § 1.17(i) of this chapter. or conveying the interest and the (c) Partial assignees. (1) If one or more (3) A statement signed by both the citizenship of the party receiving the assignee, together with one or more party conveying the interest and the interest. In addition, if the party inventor, holds the entire right, title, party receiving the interest explaining receiving the interest is a partnership or and interest in the application, the how the conveyance affects title. joint venture, the cover sheet should set patent may issue in the names of the (b) Name changes. Only a legible forth the names, legal entities, and assignee and the inventor. cover sheet is required (See § 3.31). national citizenship (or the state or (2) If multiple assignees hold the (c) All documents. (1) For electronic country of organization) of all general entire right, title, and interest to the submissions: All documents must be partners or active members that exclusion of all the inventors, the patent submitted as digitized images in Tagged compose the partnership or joint may issue in the names of the multiple Image File Format (TIFF) or another venture. assignees.

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PART 5—SECRECY OF CERTAIN ACTION: Direct final rule. Feather River Air Quality INVENTIONS AND LICENSES TO Management District, 938—14th Street, SUMMARY: EXPORT AND FILE APPLICATIONS IN EPA is taking direct final Marysville, CA 95901–4149. FOREIGN COUNTRIES action to approve revisions to the El Dorado County Air Pollution Control Kern County Air Pollution Control District, 2700 ‘‘M’’ Street, Suite 302, I 21. The authority citation for 37 CFR District (EDCAPCD), Feather River Air Bakersfield, CA 93301–2370. part 5 continues to read as follows: Quality Management District (FRAQMD), Kern County Air Pollution Authority: 35 U.S.C. 2(b)(2), 41, 181–188, Mojave Desert Air Quality as amended by the Patent Law Foreign Filing Control District (KCAPCD), Sacramento Management District, 14306 Park Amendments Act of 1988, Pub. L. 100–418, Metropolitan Air Quality Management Avenue, Victorville, CA 92392–2310. 102 Stat. 1567; the Arms Export Control Act, District (SMAQMD), San Bernardino Sacramento Metropolitan Air Quality as amended, 22 U.S.C. 2751 et seq.; the County Air Pollution Control District Management District, 777—12th Street, Atomic Energy Act of 1954, as amended, 42 (now Mojave Desert Air Quality U.S.C. 2011 et seq.; the Nuclear Non Third Floor, Sacramento, CA 95814– Management District) (MDAQMD), 1908. Proliferation Act of 1978, 22 U.S.C. 3201 et Santa Barbara County Air Pollution seq.; and the delegations in the regulations Control District (SBCAPCD), and Yolo- Santa Barbara County Air Pollution under these Acts to the Director (15 CFR Control District, 26 Castilian Drive, 370.10(j), 22 CFR 125.04, and 10 CFR 810.7). Solano Air Pollution Control District (YSAPCD) portions of the California Suite B–23, Goleta, CA 93117–3027. I 22. Revise 5.1(a) to read as follows: State Implementation Plan (SIP). Under Yolo-Solano Air Quality Management authority of the Clean Air Act as § 5.1 Applications and correspondence District, 1947 Galileo Court, Suite 103, involving national security. amended in 1990 (CAA or the Act), we Davis, CA 95616–4882. are approving local rules that address (a) All correspondence in connection Copies of the rules may also be emission statements. with this part, including petitions, available via the Internet at the DATES: should be addressed to: Mail Stop L&R, This rule is effective on July 26, following site, http://www.arb.ca.gov/ Commissioner for Patents, P.O. Box 2004, without further notice, unless drdb/drdbltxt.htm. Please be advised 1450, Alexandria, Virginia 22313–1450. EPA receives adverse comments by June that this is not an EPA Web site and 25, 2004. If we receive such comments, * * * * * may not contain the same version of the we will publish a timely withdrawal in rules that were submitted to EPA. Dated: May 18, 2004. the Federal Register to notify the public Jon W. Dudas, that this direct final rule will not take FOR FURTHER INFORMATION CONTACT: Julie Acting Under Secretary of Commerce for effect. A. Rose, EPA Region IX, (415) 947– Intellectual Property and Acting Director of ADDRESSES: Send comments to Andy 4126, [email protected]. the United States Patent and Trademark Steckel, Rulemaking Office Chief (AIR– Office. SUPPLEMENTARY INFORMATION: 4), U.S. Environmental Protection Throughout this document, ‘‘we,’’ ‘‘us’’ [FR Doc. 04–11761 Filed 5–25–04; 8:45 am] Agency, Region IX, 75 Hawthorne and ‘‘our’’ refer to EPA. BILLING CODE 3510–16–P Street, San Francisco, CA 94105–3901 or e-mail to [email protected], or Table of Contents submit comments at http:// I. The State’s Submittal ENVIRONMENTAL PROTECTION www.regulations.gov. A. What Rules Did the State Submit? AGENCY You can inspect copies of the B. Are There Other Versions of These submitted SIP revisions, EPA’s technical Rules? 40 CFR Part 52 support documents (TSDs), and public C. What Is the Purpose of the Submitted Rules? [CA 040–0448a; FRL–7662–2] comments at our Region IX office during normal business hours by appointment. II. EPA’s Evaluation and Action You may also see copies of the A. How Is EPA Evaluating the Rules? Revisions to the California State B. Do the Rules Meet the Evaluation Implementation Plan, El Dorado submitted SIP revisions by appointment Criteria? County Air Pollution Control District, at the following locations: C. EPA Recommendations To Further Feather River Air Quality Management Air and Radiation Docket and Improve the Rules District, Kern County Air Pollution Information Center, U.S. Environmental D. Public Comment and Final Action Control District, Sacramento Protection Agency, Room B–102, 1301 III. Statutory and Executive Order Reviews Constitution Avenue, NW., (Mail Code Metropolitan Air Quality Management I. The State’s Submittal District, San Bernardino County Air 6102T), Washington, DC 20460. Pollution Control District, Santa California Air Resources Board, A. What Rules Did the State Submit? Barbara County Air Pollution Control Stationary Source Division, Rule District, and Yolo-Solano Air Pollution Evaluation Section, 1001 ‘‘I’’ Street, Table 1 lists the rules we are Control District Sacramento, CA 95814. approving with the dates that they were El Dorado County Air Pollution adopted by the local air agencies and AGENCY: Environmental Protection Control District, 2850 Fairlane Court, submitted by the California Air Agency (EPA). Building C, Placerville, CA 95667–4100. Resources Board (CARB).

TABLE 1.—SUBMITTED RULES

Local agency Rule # Rule title Adopted Submitted

EDCAPCD ...... 1000 ...... Emission Statement ...... 09/21/92 11/12/92 FRAQMD ...... 4.8 ...... Further Information ...... 09/14/92 11/12/92 KCAPCD ...... 108.2 ...... Emission Statement Requirements ...... 07/13/92 11/12/92 MDAQMD ...... 107 ...... Certification and Emission Statements ...... 09/17/92 11/12/92 SMAQMD ...... 105 ...... Emission Statements ...... 04/20/93 11/18/93 SBCAPCD ...... 212 ...... Emission Statements ...... 10/20/92 11/12/92

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TABLE 1.—SUBMITTED RULES—Continued

Local agency Rule # Rule title Adopted Submitted

YSAPCD ...... 3.18 ...... Emission Statements ...... 11/15/92 11/18/93

On March 26, 1993, and December 23, II. EPA’s Evaluation and Action not think anyone will object to this 1993, the rules submitted on November approval, so we are finalizing it without A. How Is EPA Evaluating the Rules? 12, 1992, and November 18, 1993, proposing it in advance. However, in respectively were found to meet the These rules require owners or the Proposed Rules section of this completeness criteria in 40 CFR part 51, operators of sources which emit oxides Federal Register, we are simultaneously appendix V, which must be met before of nitrogen (NOX), volatile organic proposing approval of the same formal EPA review. compounds (VOC), or reactive organic submitted rules. If we receive adverse gas (ROG) to provide the Air Pollution comments by June 25, 2004, we will B. Are There Other Versions of These Control Officer (APCO) and CARB with publish a timely withdrawal in the Rules? a statement showing actual emissions of Federal Register to notify the public NOX, VOC, and ROG annually. The that the direct final approval will not There are no previous versions of statement must contain a certification take effect and we will address the these rules with the exception of by a responsible official of the company comments in a subsequent final action FRAPCD Rule 4.8, Further Information. that the information contained in the based on the proposal. If we do not We approved Sutter County Air statement is accurate. The statement receive timely adverse comments, the Pollution Control District (SCAPCD) must contain the same information direct final approval will be effective Rule 4.8, Public Information and Yuba required in CARB’s Emission Inventory without further notice on July 26, 2004. County Air Pollution Control District Turn Around Document. The CARB’s This will incorporate these rules into (YCAPCD) Rule 4.8, Further Information Emission Inventory Turn Around the federally enforceable SIP. into the California SIP on April 12, Document complies with the suggested III. Statutory and Executive Order 1982. SCAPCD and YCAPCD joined contents of an emission statement found Reviews together to form the FRAPCD on in EPA’s draft Guidance on the September 3, 1991. FRAPCD Rule 4.8 Implementation of an Emission Under Executive Order 12866 (58 FR has now been revised to include Statement Program. In combination with 51735, October 4, 1993), this action is emission statement requirements. the other requirements, these rules must not a ‘‘significant regulatory action’’ and therefore is not subject to review by the C. What Is the Purpose of the Submitted be enforceable (see section 110(a) of the Office of Management and Budget. For Rules and Rule Revision? Act) and must not relax existing requirements (see sections 110(l) and this reason, this action is also not Section 182(a)(3)(B)(i) of the CAA 193). EPA policy that we used to help subject to Executive Order 13211, requires that States with areas evaluate enforceability requirements ‘‘Actions Concerning Regulations That designated as nonattainment for ozone consistently includes the Bluebook Significantly Affect Energy Supply, require emission statement data from (‘‘Issues Relating to VOC Regulation Distribution, or Use’’ (66 FR 28355, May sources of volatile organic compounds Cutpoints, Deficiencies, and 22, 2001). This action merely approves or oxides of nitrogen in the Deviations,’’ EPA, May 25, 1988) and State law as meeting Federal nonattainment areas. This requirement the Little Bluebook (‘‘Guidance requirements and imposes no additional applies to all ozone nonattainment areas Document for Correcting Common VOC requirements beyond those imposed by regardless of the classification & Other Rule Deficiencies,’’ EPA Region State law. Accordingly, the (Marginal, Moderate, etc.). Emission 9, August 21, 2001). Administrator certifies that this rule statements were required to be will not have a significant economic B. Do the Rules Meet the Evaluation impact on a substantial number of small submitted by November 15, 1993, and Criteria? annually thereafter. Section entities under the Regulatory Flexibility 182(a)(3)(B)(ii) of the CAA allows the We believe these rules are consistent Act (5 U.S.C. 601 et seq.). Because this States and Districts to waive the with the relevant policy and guidance rule approves pre-existing requirements under State law and does not impose requirement for emission statements for regarding enforceability and SIP any additional enforceable duty beyond classes or categories of sources with less relaxations. The TSDs have more that required by State law, it does not than 25 tons per year if the class or information on our evaluation. contain any unfunded mandate or category is included in the base year C. EPA Recommendations To Further significantly or uniquely affect small and periodic inventories and emissions Improve the Rules governments, as described in the are calculated using emission factors The TSDs recommend that the Unfunded Mandates Reform Act of 1995 established by EPA or other methods CARB’s most current emission (Public Law 104–4). acceptable to EPA. inventory document, the ‘‘California This rule also does not have tribal Section 110(a) of the CAA requires Emission Inventory and Development implications because it will not have a States to submit regulations that control And Reporting System II (CEIDARSII),’’ substantial direct effect on one or more volatile organic compounds and oxides be referenced in the rules the next time Indian tribes, on the relationship of nitrogen, particulate matter, and other the local agencies modify their rules. between the Federal Government and air pollutants which harm human health Indian tribes, or on the distribution of and the environment. These rules were D. Public Comment and Final Action power and responsibilities between the developed as part of the local agency’s As authorized in section 110(k)(3) of Federal Government and Indian tribes, program to control these pollutants and the Act, EPA is fully approving the as specified by Executive Order 13175 meet the requirements of sections 110 submitted rules because we believe they (65 FR 67249, November 9, 2000). This and 182 of the CAA. fulfill all relevant requirements. We do action also does not have federalism

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implications because it does not have not affect the finality of this rule for the (1) Rule 105 adopted on April 20, substantial direct effects on the States, purposes of judicial review nor does it 1993. on the relationship between the national extend the time within which a petition (J) Yolo-Solano Air Quality government and the States, or on the for judicial review may be filed, and Management District. distribution of power and shall not postpone the effectiveness of (1) Rule 3.18 adopted on July 28, responsibilities among the various such rule or action. This action may not 1993. levels of government, as specified in be challenged later in proceedings to * * * * * Executive Order 13132 (64 FR 43255, enforce its requirements. (See section [FR Doc. 04–11769 Filed 5–25–04; 8:45 am] August 10, 1999). This action merely 307(b)(2).) BILLING CODE 6560–50–P approves a State rule implementing a Federal standard, and does not alter the List of Subjects in 40 CFR Part 52 relationship or the distribution of power Environmental protection, Air ENVIRONMENTAL PROTECTION and responsibilities established in the pollution control, Incorporation by AGENCY Clean Air Act. This rule also is not reference, Intergovernmental relations, subject to Executive Order 13045 Particulate matter, Reporting and 40 CFR Part 180 ‘‘Protection of Children from recordkeeping requirements, Sulfur [OPP–2004–0093; FRL–7355–8] Environmental Health Risks and Safety oxides. Risks’’ (62 FR 19885, April 23, 1997), Dated: May 3, 2004. Isoxadifen-Ethyl; Pesticide Tolerance because it is not economically Wayne Nastri, significant. AGENCY: Environmental Protection In reviewing SIP submissions, EPA’s Regional Administrator, Region IX. Agency (EPA). role is to approve State choices, I Part 52, Chapter I, Title 40 of the Code ACTION: Final rule. provided that they meet the criteria of of Federal Regulations is amended as SUMMARY: This regulation establishes the Clean Air Act. In this context, in the follows: three tolerances for the combined absence of a prior existing requirement residues of the herbicide safener for the State to use voluntary consensus PART 52—[AMENDED] isoxadifen-ethyl in or on rice, grain; standards (VCS), EPA has no authority I 1. The authority citation for part 52 rice, straw; and rice, hulls. Bayer to disapprove a SIP submission for continues to read as follows: CropScience (formerly Aventis failure to use VCS. It would thus be CropScience) requested this tolerance inconsistent with applicable law for Authority: 42 U.S.C. 7401 et seq. under the Federal Food, Drug, and EPA, when it reviews a SIP submission, Subpart F—California Cosmetic Act (FFDCA), as amended by to use VCS in place of a SIP submission the Food Quality Protection Act of 1996 that otherwise satisfies the provisions of I 2. Section 52.220 is amended by (FQPA). the Clean Air Act. Thus, the adding paragraphs (c)(190)(i)(C) to (G) requirements of section 12(d) of the DATES: This regulation is effective May and (c)(194)(i)(I) and (J) to read as 26, 2004. Objections and requests for National Technology Transfer and follows: Advancement Act of 1995 (15 U.S.C. hearings must be received on or before 272 note) do not apply. This rule does § 52.220 Identification of plan. July 26, 2004. not impose an information collection * * * * * ADDRESSES: To submit a written burden under the provisions of the (c) * * * objection or hearing request follow the Paperwork Reduction Act of 1995 (44 (190) * * * detailed instructions as provided in U.S.C. 3501 et seq.). (i) * * * Unit VI. of the SUPPLEMENTARY The Congressional Review Act, 5 (C) El Dorado County Air Pollution INFORMATION. EPA has established a U.S.C. 801 et seq., as added by the Small Control District. docket for this action under Docket ID Business Regulatory Enforcement (1) Rule 1000 adopted on September number OPP–2004–0093. All Fairness Act of 1996, generally provides 21, 1992. documents in the docket are listed in that before a rule may take effect, the (D) Feather River Air Pollution the EDOCKET index at http:// agency promulgating the rule must Control District. www.epa.gov/edocket. Although listed submit a rule report, which includes a (1) Rule 4.8 adopted on September 14, in the index, some information is not copy of the rule, to each House of the 1992. publicly available, i.e., Confidential Congress and to the Comptroller General (E) Kern County Air Pollution Control Business Information (CBI) or other of the United States. EPA will submit a District. information whose disclosure is report containing this rule and other (1) Rule 108.2 adopted on July 13, restricted by statute. Certain other required information to the U.S. Senate, 1992. material, such as copyrighted material, the U.S. House of Representatives, and (F) San Bernardino County Air is not placed on the Internet and will be the Comptroller General of the United Pollution Control District (now Mojave publicly available only in hard copy States prior to publication of the rule in Desert Air Quality Management form. Publicly available docket the Federal Register. A major rule District). materials are available either cannot take effect until 60 days after it (1) Rule 107 adopted on September electronically in EDOCKET or in hard is published in the Federal Register. 14, 1992. copy at the Public Information and This action is not a ‘‘major rule’’ as (G) Santa Barbara County Air Records Integrity Branch (PIRIB), Rm. defined by 5 U.S.C. 804(2). Pollution Control District. 119, Crystal Mall #2, 1921 Jefferson Under section 307(b)(1) of the Clean (1) Rule 212 adopted on October 20, Davis Hwy., Arlington, VA. This docket Air Act, petitions for judicial review of 1992. facility is open from 8:30 a.m. to 4 p.m., this action must be filed in the United * * * * * Monday through Friday, excluding legal States Court of Appeals for the (194) * * * holidays. The docket telephone number appropriate circuit by July 26, 2004. (i) * * * is (703) 305–5805. Filing a petition for reconsideration by (I) Sacramento Metropolitan Air FOR FURTHER INFORMATION CONTACT: the Administrator of this final rule does Quality Management District. James Parker, Registration Division

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(7505C), Office of Pesticide Programs, 346a(d)(3), announcing the filing of a 62961, November 26, 1997) (FRL–5754– Environmental Protection Agency, 1200 pesticide petition (PP 9E5060) by 7). Pennsylvania Ave., NW., Washington, Aventis CropScience, formerly AgrEvo III. Aggregate Risk Assessment and DC 20460–0001; telephone number: USA, now doing business as Bayer Determination of Safety (703) 308–0371; e-mail address: CropScience, P.O. Box 12014, 2 T.W. [email protected]. Alexander Drive, Research Triangle Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the SUPPLEMENTARY INFORMATION: Park, NC 27709. That notice included a summary of the petition prepared by the available scientific data and other I. General Information petitioner. relevant information in support of this The petition requested that 40 CFR action. EPA has sufficient data to assess A. Does this Action Apply to Me? 180.570 be amended by establishing the hazards of and to make a You may be potentially affected by tolerances for the combined residues of determination on aggregate exposure, this action if you are an agricultural the herbicide safener isoxadifen-ethyl, consistent with section 408(b)(2) of producer, food manufacturer, or (ethyl 5,5-diphenyl-2-isoxazoline-3- FFDCA, for a tolerance for combined pesticide manufacturer. Potentially carboxylate) (CAS No. 163520–33–0) residues of isoxadifen-ethyl (CAS No. affected entities may include, but are and its metabolites: 4,5-dihydro-5,5- 163520–33–0) and its metabolites: 4,5- not limited to: diphenyl-3-isoxazolecarboxylic acid and dihydro-5,5-diphenyl-3- • Crop production (NAICS 111), e.g., b-hydroxy-b-benezenepropanenitrile, in isoxazolecarboxylic acid and b-hydroxy- agricultural workers; greenhouse, or on the following rice commodities: b-benezenepropanenitrile on rice nursery, and floriculture workers; rice, grain; rice, straw; rice hulls; and commodities. EPA’s assessment of farmers. rice bran at 0.10, 0.25, 0.50, and 0.80 exposures and risks associated with • Animal production (NAICS 112), parts per million (ppm), respectively. establishing the tolerance follows. e.g., cattle ranchers and farmers, dairy There were no comments received in A. Toxicological Profile cattle farmers, livestock farmers. response to the notice of filing. • Food manufacturing (NAICS 311), In the Federal Register of June 21, EPA has evaluated the available e.g., agricultural workers; farmers; 2001 (66 FR 33179) (FRL–6786–1), EPA toxicity data and considered its validity, greenhouse, nursery, and floriculture established time-limited tolerances completeness, and reliability as well as workers; ranchers; pesticide applicators. (expiring June 21, 2004) for isoxadifen- the relationship of the results of the • Pesticide manufacturing (NAICS ethyl in or on rice commodities. studies to human risk. EPA has also 32532), e.g., agricultural workers; Submission of the following data was considered available information commercial applicators; farmers; required: Confined/field accumulation concerning the variability of the greenhouse, nursery, and floriculture in rotational crops study; rice processed sensitivities of major identifiable workers; residential users. commodity study; successful petition subgroups of consumers, including This listing is not intended to be method validation of the analytical infants and children. The nature of the exhaustive, but rather provides a guide enforcement method; and adequate toxic effects caused by isoxadifen ethyl for readers regarding entities likely to be storage stability data. as well as the no observed adverse effect affected by this action. Other types of Section 408(b)(2)(A)(i) of FFDCA level (NOAEL) and the lowest observed entities not listed in this unit could also allows EPA to establish a tolerance (the adverse effect level (LOAEL) from the be affected. The North American legal limit for a pesticide chemical toxicity studies reviewed by the Agency Industrial Classification System residue in or on a food) only if EPA are discussed in the Federal Register of (NAICS) codes have been provided to determines that the tolerance is ‘‘safe.’’ June 21, 2001 (66 FR 33179) (FRL– assist you and others in determining Section 408(b)(2)(A)(ii) of FFDCA 6786–1). At that time the Agency whether this action might apply to defines ‘‘safe’’ to mean that ‘‘there is a considered the toxicity database to be certain entities. If you have any reasonable certainty that no harm will complete. No additional toxicity studies questions regarding the applicability of result from aggregate exposure to the have been submitted by the petitioner. this action to a particular entity, consult pesticide chemical residue, including B. Toxicological Endpoints the person listed under FOR FURTHER all anticipated dietary exposures and all INFORMATION CONTACT. other exposures for which there is The dose at which the NOAEL from reliable information.’’ This includes the toxicology study identified as B. How Can I Access Electronic Copies exposure through drinking water and in appropriate for use in risk assessment is of this Document and Other Related residential settings, but does not include used to estimate the toxicological level Information? occupational exposure. Section of concern (LOC). However, the LOAEL In addition to using EDOCKET (http:/ 408(b)(2)(C) of FFDCA requires EPA to is sometimes used for risk assessment if /www.epa.gov/edocket/), you may give special consideration to exposure no NOAEL was achieved in the access this Federal Register document of infants and children to the pesticide toxicology study selected. An electronically through the EPA Internet chemical residue in establishing a uncertainty factor (UF) is applied to under the ‘‘Federal Register’’ listings at tolerance and to ‘‘ensure that there is a reflect uncertainties inherent in the http://www.epa.gov/fedrgstr/. A reasonable certainty that no harm will extrapolation from laboratory animal frequently updated electronic version of result to infants and children from data to humans and in the variations in 40 CFR part 180 is available at E-CFR aggregate exposure to the pesticide sensitivity among members of the Beta Site Two at http:// chemical residue. . . .’’ human population as well as other www.gpoaccess.gov/ecfr/. EPA performs a number of analyses to unknowns. An UF of 100 is routinely determine the risks from aggregate used, 10X to account for interspecies II. Background and Statutory Findings exposure to pesticide residues. For differences and 10X for intraspecies In the Federal Registers of June 9, further discussion of the regulatory differences. 1999 (64 FR 30997) (FRL–6082–6), and requirements of section 408 of FFDCA Three other types of safety or June 30, 2000 (65 FR 40632) (FRL– and a complete description of the risk uncertainty factors may be used: 6592–6), EPA issued notices pursuant to assessment process, see the final rule on ‘‘Traditional uncertainty factors;’’ the section 408(d)(3) of FFDCA, 21 U.S.C. Bifenthrin Pesticide Tolerances (62 FR ‘‘special FQPA safety factor;’’ and the

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‘‘default FQPA safety factor.’’ By the decided that there are reliable data to Population Adjusted Dose (aPAD or term ‘‘traditional uncertainty factor,’’ choose a different additional factor cPAD) is a modification of the RfD to EPA is referring to those additional (potentially a traditional uncertainty accommodate this type of safety factor. uncertainty factors used prior to FQPA factor or a special FQPA safety factor). For non-dietary risk assessments For dietary risk assessment (other passage to account for database (other than cancer) the UF is used to than cancer) the Agency uses the UF to deficiencies. These traditional determine the LOC. For example, when calculate an acute or chronic reference uncertainty factors have been 100 is the appropriate UF (10X to dose (acute RfD or chronic RfD) where incorporated by the FQPA into the account for interspecies differences and the RfD is equal to the NOAEL divided additional safety factor for the by an UF of 100 to account for 10X for intraspecies differences) the protection of infants and children. The interspecies and intraspecies differences LOC is 100. To estimate risk, a ratio of term ‘‘special FQPA safety factor’’ refers and any traditional uncertainty factors the NOAEL to exposures (margin of to those safety factors that are deemed deemed appropriate (RfD = NOAEL/UF). exposure (MOE) = NOAEL/exposure) is necessary for the protection of infants Where a special FQPA safety factor or calculated and compared to the LOC. and children primarily as a result of the the default FQPA safety factor is used, A summary of the toxicological FQPA. The ‘‘default FQPA safety factor’’ this additional factor is applied to the endpoints for isoxadifen-ethyl used for is the additional 10X safety factor that RfD by dividing the RfD by such human risk assessment is shown in is mandated by the statute unless it is additional factor. The acute or chronic Table 1. of this unit:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR ISOXADIFEN-ETHYL FOR USE IN HUMAN RISK ASSESSMENT

Dose Used in Risk Assess- ment, Interspecies and Special FQPA SF and Exposure Scenario Intraspecies and any Tradi- LOC for Risk Assessment Study and Toxicological Effects tional UF

Acute dietary (females 13–50 NOAEL = 15 milligrams/kilo- Special FQPA SF = 1X Rat developmental study years of age) grams/day (mg/kg/day) aPAD = acute RfD ÷ Spe- LOAEL = 120 mg/kg/day based on bent scap- UF = 100 cial FQPA SF = 0.15 ula in rat fetuses Acute RfD = 0.15 mg/kg/day mg/kg/day

Chronic dietary (all populations) NOAEL = 3.3 mg/kg/day Special FQPA SF = 1X 1–Year dog feeding study, (co-critical) 90–day UF = 100 cPAD = chronic RfD ÷ dog feeding study Chronic RfD = 0.033 mg/kg/ Special FQPA SF = LOAEL = 6.1 mg/kg/day based on kidney day 0.033 mg/kg/day histopathology in both sexes of dogs in both studies

Short-term dermal, inhalation, Dermal (or oral) study LOC for MOE = <100% 90–day rat feeding study and incidental oral (1 to 7 NOAEL = 13.8 mg/kg/day (Residential) LOAEL = 137.9 mg/kg/day based on de- days) (dermal absorption rate = creased body weight and weight gain at Day (Residential) 14%) 8 (inhalation absorption rate = 100%)

Intermediate-term dermal, inha- Dermal (or oral) study LOC for MOE = <100% 1-Year dog feeding study (co-critical) 90–day lation, and incidental oral (1 NOAEL = 3.3 mg/kg/day (Residential) dog feeding study week to several months) (dermal absorption rate = LOAEL = 6.1 mg/kg/day based on kidney (Residential) 14%) histopathology in both sexes of dogs in both (inhalation absorption rate = studies 100%)

Cancer (oral, dermal, inhala- Cancer classification ‘‘not Risk assessment not re- No evidence of carcinogenicity tion) likely to be a human car- quired cinogen’’

C. Exposure Assessment Agency’s review of residue chemistry day or single exposure. In conducting 1. Dietary exposure from food and data indicated that residues of the acute dietary risk assessment EPA feed uses. Permanent tolerances on corn isoxadifen-ethyl do not concentrate in used the Dietary Exposure Evaluation commodities and time-limited rice, bran. Therefore, the rice, grain Model software with the Food tolerances on rice commodities are tolerance will cover this processed Commodity Intake Database (DEEM- established (40 CFR 180.570) for the commodity. The existing time-limited FCIDTM), which incorporates food combined residues of isoxadifen-ethyl. tolerance for rice, bran is therefore not consumption data as reported by The time-limited tolerances will expire needed and will be removed. Hence, a respondents in the U.S. Department of on June 21, 2004. To convert these time- permanent tolerance for rice, bran is not Agriculture (USDA) 1994–1996 and limited tolerances to permanent established in this final rule. 1998 nationwide Continuing Surveys of tolerances, risk assessments were i. Acute exposure. Acute dietary risk Food Intake by Individuals (CSFII), and conducted by EPA to assess dietary assessments are performed for a food- accumulated exposure to the chemical exposures from isoxadifen-ethyl. use pesticide, if a toxicological study for each commodity. The following At this time there is a time-limited has indicated the possibility of an effect assumptions were made for the acute tolerance for rice, bran at 0.80 ppm. The of concern occurring as a result of a 1– exposure assessments: Tolerance level

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residues, 100% crop treated and DEEM aPAD and therefore less than the Tolerance level residues, 100% crop (version 7.76) default concentration Agency’s LOC. treated and DEEM (version 7.76) default factors for all commodities. No ii. Chronic exposure. In conducting processing factors. No anticipated anticipated residues were used. the chronic dietary risk assessment EPA residues were used. The chronic dietary The Agency estimated the acute used the DEEM-FCIDTM, which exposure estimates were all less than or dietary food exposure for females (ages incorporates food consumption data as equal to 1.5% of the cPAD for all 13–49 years old) to be 0.000511 mg/kg/ reported by respondents in the USDA population subgroups and are therefore day. The Agency’s LOC for acute dietary 1994–1996 and 1998 nationwide CSFII, less than the LOC (greater than 100% of risk is greater than 100% of the aPAD. and accumulated exposure to the the cPAD). The chronic dietary When compared to the aPAD of 0.15 chemical for each commodity. The exposure estimates for representative mg/kg/day for isoxadifen-ethyl, the following assumptions were made for population subgroups are presented dietary risk is less than 1.0% of the the chronic exposure assessments: below in Table 2:

TABLE 2.—SUMMARY OF CHRONIC DIETARY EXPOSURE FOR ISOXADIFEN-ETHYL

Subgroup Exposure (mg/kg/day) % cPAD

U.S. population (total) 0.000216 <1.0

All infants (<1–year old) 0.000339 1

Children (1–2 years old) 0.000427 1.3

Children (3–5 years old) 0.000486 1.5

Children (6–12 years old) 0.000373 1.1

Youth (13–19 years old) 0.000294 <1.0

Adults (20–49 years old) 0.000182 <1.0

Adults (50+ years old) 0.000099 <1.0

Females (13–49 years old) 0.000177 <1.0

iii. Cancer. After consideration of the screening-level assessment for surface calculated and used as a point of Agency’s ‘‘Proposed Guidelines for water. The GENEEC model is a subset of comparison against the model estimates Carcinogen Risk Assessment (April 10, the PRZM/EXAMS model that uses a of a pesticide’s concentration in water. 1996),’’ EPA has classified isoxadifen- specific high-end runoff scenario for DWLOCs are theoretical upper limits on ethyl as ‘‘not likely to be a human pesticides. GENEEC incorporates a farm a pesticide’s concentration in drinking carcinogen.’’ This classification is based pond scenario, while PRZM/EXAMS water in light of total aggregate exposure on the lack of evidence of incorporates an index reservoir to a pesticide in food and from carcinogenicity in mice and rats. environment in place of the previous residential uses. Since DWLOCs address Therefore, a cancer risk analysis is not pond scenario. The PRZM/EXAMS total aggregate exposure to isoxadifen- necessary. model includes a percent crop area ethyl, they are further discussed in the 2. Dietary exposure from drinking factor as an adjustment to account for aggregate risk sections in Unit III.E. water. The Agency lacks sufficient the maximum percent crop coverage Based on the GENEEC, FQPA Index monitoring exposure data to complete a within a watershed or drainage basin. Reservoir Screening Tool (FIRST) and comprehensive dietary exposure None of these models include SCI-GROW models, the EECs of analysis and risk assessment for consideration of the impact processing isoxadifen-ethyl for acute exposures are isoxadifen-ethyl in drinking water. (mixing, dilution, or treatment) of raw estimated to be 80 parts per billion Because the Agency does not have water for distribution as drinking water (ppb) for surface water and 5 ppb for comprehensive monitoring data, would likely have on the removal of ground water. The EECs for chronic drinking water concentration estimates pesticides from the source water. The exposures are estimated to be 40 ppb for are made by reliance on simulation or primary use of these models by the surface water and 5 ppb for ground modeling taking into account data on Agency at this stage is to provide a water. the physical characteristics of screen for sorting out pesticides for 3. From non-dietary exposure. The isoxadifen-ethyl. which it is unlikely that drinking water term ‘‘residential exposure’’ is used in The Agency uses the Generic concentrations would exceed human this document to refer to non- Estimated Environmental Concentration health LOCs. occupational, non-dietary exposure (GENEEC) or the Pesticide Root Zone Since the models used are considered (e.g., for lawn and garden pest control, Model/Exposure Analysis Modeling to be screening tools in the risk indoor pest control, termiticides, and System (PRZM/EXAMS) to estimate assessment process, the Agency does flea and tick control on pets). The pesticide concentrations in surface not use estimated environmental petitioner has requested to use water and Screening Concentration in concentrations (EECs), which are the isoxadifen-ethyl on turf, which could Ground Water (SCI-GROW), which model estimates of a pesticide’s result in residential exposures. predicts pesticide concentrations in concentration in water, used to quantify The proposed turf use is intended for ground water. In general, EPA will use drinking water exposure and risk as a professional application to GENEEC (a Tier I model) before using %RfD or %PAD. Instead drinking water Bermudagrass on golf courses, sod PRZM/EXAMS (a Tier II model) for a levels of comparison (DWLOC) are farms, residential and commercial site

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lawns, parks, recreational facilities, and D. Safety Factor for Infants and in this study (15 mg/kg/day) is used as similar sites. It is not intended for use Children the basis for the aRfD for the females by homeowners or other non- 1. In general. Section 408 of FFDCA 13–50 population subgroup. For all professional applications. Therefore, provides that EPA shall apply an other toxicity endpoints established for residential mixer/loader and applicator additional tenfold margin of safety for isoxadifen-ethyl, a NOAEL lower than exposures are not anticipated. The infants and children in the case of this developmental NOAEL is used. • The residue chemistry and following short-term post-application threshold effects to account for prenatal environmental fate databases are residential exposures are anticipated: and postnatal toxicity and the complete. Adult (dermal - golf course and completeness of the database on toxicity • The acute and chronic dietary food residential lawn), children (dermal - and exposure unless EPA determines exposure assessments assumed residential lawn), and toddler (dermal based on reliable data that a different tolerance level residues and 100% crop and incidental oral - residential lawn). margin of safety will be safe for infants treated for all crops. Therefore dietary However, dermal exposures for golfers and children. Margins of safety are exposures/risks are unlikely to be are considered to be less than those incorporated into EPA risk assessments underestimated. resulting from a residential turf either directly through use of a MOE • The drinking water assessment application, and were therefore not analysis or through using uncertainty utilizes water concentration values assessed. (safety) factors in calculating a dose generated by models and associated level that poses no appreciable risk to modeling parameters which are Hand to mouth (HTM), object to humans. In applying this provision, mouth (OTM), and soil hand to mouth designed to provide conservative, health EPA either retains the default value of protective, high-end estimates of short-term incidental oral exposures 10X when reliable data do not support may occur as a result of the proposed drinking water concentrations. the choice of a different factor, or, if • The residential assessment is turf use. However, the soil hand to reliable data are available, EPA uses a considered a Tier I assessment. mouth exposure is considered to be very different additional safety factor value Therefore residential exposures/risks small in comparison to the other based on the use of traditional are unlikely to be underestimated. exposures. MOEs were estimated to be uncertainty factors and/or special FQPA 790 (for a 15 kg child) and 1,500 (for an safety factors, as appropriate. E. Aggregate Risks and Determination of adult). MOEs greater than 100 are not of 2. Prenatal and postnatal sensitivity. Safety concern. A summary of the developmental To estimate total aggregate exposure 4. Cumulative effects from substances toxicity studies for isoxadifen-ethyl to a pesticide from food, drinking water, with a common mechanism of toxicity. which have been reviewed and and residential uses, the Agency Section 408(b)(2)(D)(v) of FFDCA evaluated by the Agency published in calculates DWLOCs which are used as a the Federal Register of June 21, 2001 requires that, when considering whether point of comparison against EECs. (66 FR 33179) (FRL–6786–1). DWLOC values are not regulatory to establish, modify, or revoke a 3. Conclusion. Based on the following standards for drinking water. DWLOCs tolerance, the Agency consider considerations, the Agency concluded are theoretical upper limits on a ‘‘available information’’ concerning the that the special FQPA safety factor is pesticide’s concentration in drinking cumulative effects of a particular reduced to 1X. water in light of total aggregate exposure pesticide’s residues and ‘‘other • No neurotoxicity studies are to a pesticide in food and residential substances that have a common available. However, no clinical signs of uses. In calculating a DWLOC, the mechanism of toxicity.’’ neurotoxicity were observed in the Agency determines how much of the Unlike other pesticides for which EPA available toxicity studies conducted acceptable exposure (i.e., the PAD) is has followed a cumulative risk approach with isoxadifen-ethyl in rats, rabbits, or available for exposure through drinking based on a common mechanism of dogs, other than those neurotoxic water (e.g., allowable chronic water toxicity, EPA has not made a common clinical signs associated with agonal exposure (mg/kg/day) = cPAD - (average toxicity in these species. food + residential exposure)). This mechanism of toxicity finding as to • isoxadifen-ethyl and any other There was no evidence of allowable exposure through drinking substances and isoxadifen-ethyl does enhanced susceptibility in the rabbit water is used to calculate a DWLOC. not appear to produce a toxic metabolite developmental study or the 2– A DWLOC will vary depending on the generation rat reproduction study. produced by other substances. For the toxic endpoint, drinking water • In the developmental rat study, purposes of this tolerance action, consumption, and body weights. Default quantitative susceptibility was body weights and consumption values therefore, EPA has not assumed that evidenced as increased fetal incidences as used by the EPA’s Office of Water are isoxadifen-ethyl has a common of bent scapula at (120 mg/kg/day) a used to calculate DWLOCs: 2 liter (L)/ mechanism of toxicity with other dose lower than that evoking maternal 70 kg (adult male), 2L/60 kg (adult substances. For information regarding toxicity (mortality, reduced body female), and 1L/10 kg (child). Default EPA’s efforts to determine which weights, body weight gains, and food body weights and drinking water chemicals have a common mechanism consumption at 1,000 mg/kg/day). The consumption values vary on an of toxicity and to evaluate the overall toxicity profile and the doses individual basis. This variation will be cumulative effects of such chemicals, and endpoints selected for risk taken into account in more refined see the policy statements released by assessment for isoxadifen-ethyl, screening-level and quantitative EPA’s Office of Pesticide Programs characterize the degree of concern for drinking water exposure assessments. concerning common mechanism the effects observed in this study as low. Different populations will have different determinations and procedures for There is a clear NOAEL and well- DWLOCs. For isoxadifen-ethyl DWLOCs cumulating effects from substances characterized dose response for the are calculated for: Acute, short-term, found to have a common mechanism on developmental effects observed. No and chronic scenarios. EPA’s web site at http://www.epa.gov/ residual uncertainties were identified. When EECs for surface water and pesticides/cumulative/. The NOAEL for developmental effects ground water are less than the

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calculated DWLOCs, EPA concludes pesticide’s uses, levels of comparison in dietary exposure from food to with reasonable certainty that exposures drinking water may vary as those uses isoxadifen-ethyl will occupy <1.0% of to the pesticide in drinking water (when change. If new uses are added in the the aPAD for females ages 13 and 50 considered along with other sources of future, EPA will reassess the potential years old. In addition, there is potential exposure for which EPA has reliable impacts of residues of the pesticide in for acute dietary exposure to isoxadifen- data) would not result in unacceptable drinking water as a part of the aggregate ethyl in drinking water. The DWLOC is levels of aggregate human health risk at risk assessment process. much greater than the EECs. Therefore, this time. Because EPA considers the 1. Acute risk. Using the exposure EPA does not expect acute aggregate aggregate risk resulting from multiple assumptions previously discussed in exposure to exceed 100% of the aPAD, exposure pathways associated with a this unit for acute exposure, the acute as shown in Table 3 of this unit:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO ISOXADIFEN-ETHYL

Surface Ground Acute Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC DWLOC kg) (Food) (ppb) (ppb) (ppb)

Females (13–50 years old) 0.15 <1.0 80 5 4,500

2. Chronic risk. Using the chronic cPAD for children 3–5 years old. Based is much greater than the estimated EEC. dietary exposure analysis discussed on the use pattern, chronic residential Therefore, EPA does not expect the previously, EPA has concluded that exposure to residues of isoxadifen-ethyl aggregate exposure to exceed 100% of exposure to isoxadifen-ethyl from food is not expected. But, there is potential the cPAD. Thus, there is no concern for will utilize <1.0% of the cPAD for the for chronic dietary exposure to chronic aggregate exposure to U.S. population, 1.0% of the cPAD for isoxadifen-ethyl in drinking water. For isoxadifen-ethyl, as shown in Table 4. all infants (<1 year old), and 1.5% of the each population subgroup, the DWLOC below:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO ISOXADIFEN-ETHYL

Surface Ground Chronic Population Subgroup cPAD mg/ % cPAD Water EEC Water EEC DWLOC kg/day (Food) (ppb) (ppb) (ppb)

U.S. population 0.033 <1.0 40 5 1,100

All infants (< 1 year old) 0.033 1.0 40 5 330

Children (1–2 years old) 0.033 1.3 40 5 330

Children (3–5 years old) 0.033 1.5 40 5 330

Children (6–12 years old) 0.033 1.1 40 5 330

Youth (13–19 years old) 0.033 <1.0 40 5 980

Adults (20–49 years old) 0.033 <1.0 40 5 1,100

Adults (50+ years old) 0.033 < 1.0 40 5 1,200

Females (13–49 years old) 0.033 <1.0 40 5 980

3. Short-term risk. Short-term Using the exposure assumptions do not exceed the Agency’s LOC (<100) aggregate exposure takes into account described in this unit for short-term for aggregate exposure to food and residential exposure plus chronic exposures, EPA has concluded that residential uses. In addition, short-term exposure to food and water (considered aggregated food and residential DWLOCs were calculated and compared to be a background exposure level). exposures result in the following to the chronic EECs of isoxadifen-ethyl Isoxadifen-ethyl is proposed for a use aggregate MOEs: U.S. population in ground water and surface water. < that could result in short-term (1,450), all infants 1 year old (780), DWLOCs were calculated and then residential exposure, and the Agency children 1–2 years old (776), children compared to the EECs for surface water has determined that it is appropriate to 3–5 years old (774), children 6–12 years and ground water. All DWLOCs are aggregate chronic food and water, and old (779), youth 13–19 years old (1,438), greater than the EECs. Therefore, EPA short-term exposures for isoxadifen- adults 20–49 years old (1,455), adults does not expect short-term aggregate ethyl. 50+ years old (1,468) and females 13–49 exposure to exceed the Agency’s LOC, years old (1,456). These aggregate MOEs as shown in Table 5 below:

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TABLE 5.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO ISOXADIFEN-ETHYL

Aggregate MOE (Food Aggregate Surface Ground Short-Term Population Subgroup + Residen- LOC Water EEC Water EEC DWLOC tial) (ppb) (ppb) (ppb)

U.S. population 1450 100 40 5 4,500

All Infants (<1 year old) 780 100 40 5 1,200

Children (1–2 years old) 776 100 40 5 1,200

Children (3–5 years old) 774 100 40 5 1,200

Children (6–12 years old) 779 100 40 5 1,200

Youth (13–19 years old) 1,438 100 40 5 3,900

Adults (20–49 years old) 1,455 100 40 5 4,500

Adults (50+ years old) 1,468 100 40 5 4,500

Females (13–49 years old) 1,456 100 40 5 3,900

4. Intermediate-term risk. B. International Residue Limits A. What Do I Need to Do to File an Intermediate-term aggregate exposure Objection or Request a Hearing? takes into account residential exposure There are no CODEX, Canadian, or Mexican tolerances/maximum residue You must file your objection or plus chronic exposure to food and water request a hearing on this regulation in levels for isoxadifen-ethyl residues. (considered to be a background accordance with the instructions exposure level). Isoxadifen-ethyl is not V. Conclusion provided in this unit and in 40 CFR part used or proposed for use on any sites 178. To ensure proper receipt by EPA, that would result in intermediate-term Therefore, tolerances are established you must identify docket ID number residential exposure. Therefore an for combined residues of isoxadifen- OPP–2004–0093 in the subject line on intermediate-term risk assessment is not ethyl, ethyl 4,5-dihydro-5,5-diphenyl-3- the first page of your submission. All needed. isoxazolecarboxylate (CAS 163520–33– requests must be in writing, and must be 5. Aggregate cancer risk for U.S. 0) and its metabolites: 4,5-dihydro-5,5- mailed or delivered to the Hearing Clerk population. The Agency has classified diphenyl-3-isoxazolecarboxylic acid and on or before July 26, 2004. isoxadifen-ethyl as ‘‘not likely to be a b-hydroxy-b-benezenepropanenitrile, in 1. Filing the request. Your objection carcinogen.’’ Therefore, isoxadifen-ethyl or on rice commodities: Rice, grain; rice, must specify the specific provisions in is not expected to pose a cancer risk. straw; and rice, hulls at 0.10, 0.25, and the regulation that you object to, and the 6. Determination of safety. Based on 0.50 ppm, respectively. grounds for the objections (40 CFR these risk assessments, EPA concludes 178.25). If a hearing is requested, the that there is a reasonable certainty that VI. Objections and Hearing Requests objections must include a statement of the factual issues(s) on which a hearing no harm will result to the general Under section 408(g) of FFDCA, as is requested, the requestor’s contentions population, and to infants and children amended by FQPA, any person may file on such issues, and a summary of any from aggregate exposure to isoxadifen- an objection to any aspect of this ethyl residues. evidence relied upon by the objector (40 regulation and may also request a CFR 178.27). Information submitted in IV. Other Considerations hearing on those objections. The EPA connection with an objection or hearing procedural regulations which govern the A. Analytical Enforcement Methodology request may be claimed confidential by submission of objections and requests marking any part or all of that The Agency has reviewed the for hearings appear in 40 CFR part 178. information as CBI. Information so analytical method validation data Although the procedures in those marked will not be disclosed except in submitted by Bayer CropScience and the regulations require some modification to accordance with procedures set forth in data submitted with the Independent reflect the amendments made to FFDCA 40 CFR part 2. A copy of the Laboratory Validation (ILV). The ILV by FQPA, EPA will continue to use information that does not contain CBI reported that the method worked well. those procedures, with appropriate must be submitted for inclusion in the The Agency believes the method is adjustments, until the necessary public record. Information not marked suitable for enforcement. modifications can be made. The new confidential may be disclosed publicly Adequate enforcement methodology section 408(g) of FFDCA provides by EPA without prior notice. (example—gas chromotography) is essentially the same process for persons Mail your written request to: Office of available to enforce the tolerance to ‘‘object’’ to a regulation for an the Hearing Clerk (1900C), expression. The method may be exemption from the requirement of a Environmental Protection Agency, 1200 requested from: Chief, Analytical tolerance issued by EPA under new Pennsylvania Ave., NW., Washington, Chemistry Branch, Environmental section 408(d) of FFDCA, as was DC 20460–0001. You may also deliver Science Center, 701 Mapes Rd., Ft. provided in the old sections 408 and your request to the Office of the Hearing Meade, MD 20755–5350; telephone 409 of FFDCA. However, the period for Clerk in Rm. 104, Crystal Mall #2, 1921 number: (410) 305–2905; e-mail address: filing objections is now 60 days, rather Jefferson Davis Hwy., Arlington, VA. [email protected]. than 30 days. The Office of the Hearing Clerk is open

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from 8 a.m. to 4 p.m., Monday through of your request at many Federal the tolerance in this final rule, do not Friday, excluding legal holidays. The Depository Libraries. require the issuance of a proposed rule, telephone number for the Office of the the requirements of the Regulatory B. When Will the Agency Grant a Hearing Clerk is (703) 603–0061. Request for a Hearing? Flexibility Act (RFA) (5 U.S.C. 601 et 2. Tolerance fee payment. If you file seq.) do not apply. In addition, the an objection or request a hearing, you A request for a hearing will be granted Agency has determined that this action must also pay the fee prescribed by 40 if the Administrator determines that the will not have a substantial direct effect CFR 180.33(i) or request a waiver of that material submitted shows the following: on States, on the relationship between fee pursuant to 40 CFR 180.33(m). You There is a genuine and substantial issue the national government and the States, must mail the fee to: EPA Headquarters of fact; there is a reasonable possibility or on the distribution of power and Accounting Operations Branch, Office that available evidence identified by the responsibilities among the various of Pesticide Programs, P.O. Box requestor would, if established resolve levels of government, as specified in 360277M, Pittsburgh, PA 15251. Please one or more of such issues in favor of Executive Order 13132, entitled identify the fee submission by labeling the requestor, taking into account Federalism (64 FR 43255, August 10, it ‘‘Tolerance Petition Fees.’’ uncontested claims or facts to the 1999). Executive Order 13132 requires contrary; and resolution of the factual EPA is authorized to waive any fee EPA to develop an accountable process issues(s) in the manner sought by the requirement ‘‘when in the judgement of to ensure ‘‘meaningful and timely input requestor would be adequate to justify the Administrator such a waiver or by State and local officials in the the action requested (40 CFR 178.32). refund is equitable and not contrary to development of regulatory policies that the purpose of this subsection.’’ For VII. Statutory and Executive Order have federalism implications.’’ ‘‘Policies additional information regarding the Reviews that have federalism implications’’ is waiver of these fees, you may contact This final rule establishes a tolerance defined in the Executive Order to James Tompkins by phone at (703) 305– under section 408(d) of FFDCA in include regulations that have 5697, by e-mail at response to a petition submitted to the ‘‘substantial direct effects on the States, [email protected], or by mailing a Agency. The Office of Management and on the relationship between the national request for information to Mr. Tompkins Budget (OMB) has exempted these types government and the States, or on the at Registration Division (7505C), Office of actions from review under Executive distribution of power and of Pesticide Programs, Environmental Order 12866, entitled Regulatory responsibilities among the various Protection Agency, 1200 Pennsylvania Planning and Review (58 FR 51735, levels of government.’’ This final rule Ave., NW., Washington, DC 20460– October 4, 1993). Because this rule has directly regulates growers, food 0001. been exempted from review under processors, food handlers and food If you would like to request a waiver Executive Order 12866 due to its lack of retailers, not States. This action does not of the tolerance objection fees, you must significance, this rule is not subject to alter the relationships or distribution of mail your request for such a waiver to: Executive Order 13211, Actions power and responsibilities established James Hollins, Information Resources Concerning Regulations That by Congress in the preemption and Services Division (7502C), Office of Significantly Affect Energy Supply, provisions of section 408(n)(4) of Pesticide Programs, Environmental Distribution, or Use (66 FR 28355, May FFDCA. For these same reasons, the Protection Agency, 1200 Pennsylvania 22, 2001). This final rule does not Agency has determined that this rule Ave., NW., Washington, DC 20460– contain any information collections does not have any ‘‘tribal implications’’ 0001. subject to OMB approval under the as described in Executive Order 13175, 3. Copies for the Docket. In addition Paperwork Reduction Act (PRA), 44 entitled Consultation and Coordination to filing an objection or hearing request U.S.C. 3501 et seq., or impose any with Indian Tribal Governments (65 FR with the Hearing Clerk as described in enforceable duty or contain any 67249, November 6, 2000). Executive Unit VI.A., you should also send a copy unfunded mandate as described under Order 13175, requires EPA to develop of your request to the PIRIB for its Title II of the Unfunded Mandates an accountable process to ensure inclusion in the official record that is Reform Act of 1995 (UMRA) (Public ‘‘meaningful and timely input by tribal described in ADDRESSES. Mail your Law 104–4). Nor does it require any officials in the development of copies, identified by docket ID number special considerations under Executive regulatory policies that have tribal OPP–2004–0093, to: Public Information Order 12898, entitled Federal Actions to implications.’’ ‘‘Policies that have tribal and Records Integrity Branch, Address Environmental Justice in implications’’ is defined in the Information Resources and Services Minority Populations and Low-Income Executive Order to include regulations Division (7502C), Office of Pesticide Populations (59 FR 7629, February 16, that have ‘‘substantial direct effects on Programs, Environmental Protection 1994); or OMB review or any Agency one or more Indian tribes, on the Agency, 1200 Pennsylvania Ave., NW., action under Executive Order 13045, relationship between the Federal Washington, DC 20460–0001. In person entitled Protection of Children from Government and the Indian tribes, or on or by courier, bring a copy to the Environmental Health Risks and Safety the distribution of power and location of the PIRIB described in Risks (62 FR 19885, April 23, 1997). responsibilities between the Federal ADDRESSES. You may also send an This action does not involve any Government and Indian tribes.’’ This electronic copy of your request via e- technical standards that would require rule will not have substantial direct mail to: [email protected]. Please use Agency consideration of voluntary effects on tribal governments, on the an ASCII file format and avoid the use consensus standards pursuant to section relationship between the Federal of special characters and any form of 12(d) of the National Technology Government and Indian tribes, or on the encryption. Copies of electronic Transfer and Advancement Act of 1995 distribution of power and objections and hearing requests will also (NTTAA), Public Law 104–113, section responsibilities between the Federal be accepted on disks in WordPerfect 12(d) (15 U.S.C. 272 note). Since Government and Indian tribes, as 6.1/8.0 or ASCII file format. Do not tolerances and exemptions that are specified in Executive Order 13175. include any CBI in your electronic copy. established on the basis of a petition Thus, Executive Order 13175 does not You may also submit an electronic copy under section 408(d) of FFDCA, such as apply to this rule.

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VIII. Congressional Review Act ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: The Congressional Review Act, 5 AGENCY I. General Information U.S.C. 801 et seq., as added by the Small 40 CFR Part 180 Business Regulatory Enforcement A. Does this Action Apply to Me? Fairness Act of 1996, generally provides [OPP–2004–0056; FRL–7357–6] You may be potentially affected by that before a rule may take effect, the this action if you are an agricultural agency promulgating the rule must Ultramarine Blue; Exemption From the producer, food manufacturer, or submit a rule report, which includes a Requirement of a Tolerance pesticide manufacturer. Potentially copy of the rule, to each House of the AGENCY: Environmental Protection affected entities may include, but are Congress and to the Comptroller General Agency (EPA). not limited to: of the United States. EPA will submit a • Crop production (NAICS code 111) ACTION: Final rule. report containing this rule and other • Animal production (NAICS code required information to the U.S. Senate, SUMMARY: This regulation establishes an 112) • the U.S. House of Representatives, and exemption from the requirement of a Food manufacturing (NAICS code the Comptroller General of the United tolerance for residues of ultramarine 311) • States prior to publication of this final blue when used as an inert ingredient in Pesticide manufacturing (NAICS rule in the Federal Register. This final pesticide products. Holliday Pigments code 32532) rule is not a ‘‘major rule’’ as defined by Limited submitted a petition to EPA This listing is not intended to be 5 U.S.C. 804(2). under the Federal Food, Drug, and exhaustive, but rather provides a guide List of Subjects in 40 CFR Part 180 Cosmetic Act (FFDCA), as amended by for readers regarding entities likely to be the Food Quality Protection Act of 1996 affected by this action. Other types of Environmental protection, (FQPA), requesting an exemption from entities not listed in this unit could also Administrative practice and procedure, the requirement of a tolerance. This be affected. The North American Agricultural commodities, Pesticides regulation eliminates the need to Industrial Classification System and pests, Reporting and recordkeeping establish a maximum permissible level (NAICS) codes have been provided to requirements. for residues of ultramarine blue. assist you and others in determining I Therefore, 40 CFR chapter I is DATES: whether this action might apply to amended as follows: This regulation is effective May 26, 2004. Objections and requests for certain entities. If you have any questions regarding the applicability of PART 180—[AMENDED] hearings must be received on or before July 26, 2004. this action to a particular entity, consult I 1. The authority citation for part 180 the person listed under FOR FURTHER ADDRESSES: To submit a written continues to read as follows: INFORMATION CONTACT. objection or hearing request follow the Authority: 21 U.S.C. 321(q), 346(a) and detailed instructions as provided in B. How Can I Access Electronic Copies 371. Unit VIII. of the SUPPLEMENTARY of this Document and Other Related I 2. Section 180.570 is amended by INFORMATION. EPA has established a Information? revising paragraph (a)(2) to read as docket for this action under docket ID In addition to using EDOCKET (http:/ follows: number OPP–2004–0056. All /www.epa.gov/edocket/), you may § 180.570 Isoxadifen-ethyl; tolerances for documents in the docket are listed in access this Federal Register document residues. the EDOCKET index at http:// electronically through the EPA Internet (a)*** www.epa.gov/edocket. Although listed under the ‘‘Federal Register’’ listings at (2) Tolerances are established for the in the index, some information is not http://www.epa.gov/fedrgstr/. A residues of isoxadifen-ethyl (3- publicly available, i.e., Confidential frequently updated electronic version of isoxazolecarboxylic acid, 4,5-dihydro- Business Information (CBI) or other 40 CFR part 180 is available at E-CFR 5,5-diphenyl-, ethyl ester (CAS No. information whose disclosure is Beta Site Two at http:// 163520–33–0)), and its metabolites 4,5- restricted by statute. Certain other www.gpoaccess.gov/ecfr/. dihydro-5,5-diphenyl-3- material, such as copyrighted material, II. Background and Statutory Findings isoxazolecarboxylic acid and b-hydroxy- is not placed on the Internet and will be b-benezenepropanenitrile when used as publicly available only in hard copy In the Federal Register of March 12, an inert ingredient (safener) in or on the form. Publicly available docket 2003 (68 FR 11843) (FRL–7295–3), EPA following raw agricultural commodities, materials are available either issued a notice pursuant to section 408 when applied at an annual application electronically in EDOCKET or in hard of the FFDCA, 21 U.S.C. 346a, as rate of 0.17 pounds isoxadifen-ethyl/ copy at the Public Information and amended by the FQPA (Public Law 104– acre. Records Integrity Branch (PIRIB), Rm. 170), announcing the filing of a 119, Crystal Mall #2, 1921 Jefferson pesticide petition (3E6549) by Holliday Commodity Parts per million Davis Hwy., Arlington, VA. This docket Pigments Limited, Morley Street, Hull, facility is open from 8:30 a.m. to 4 p.m., East Yorkshire, England, HU88DN. That Rice, grain ...... 0.10 Monday through Friday, excluding legal notice included a summary of the Rice, hulls ...... 0.50 holidays. The docket telephone number petition prepared by the petitioner. Rice, straw ...... 0.25 is (703) 305–5805. The petition requested that 40 CFR FOR FURTHER INFORMATION CONTACT: * * * * * part 180 be amended by establishing an James Parker, Registration Division exemption from the requirement of a Dated: May 11, 2004. (7505C), Office of Pesticide Programs, tolerance for residues of ultramarine Lois Rossi, Environmental Protection Agency, 1200 blue, which is also known as C.I. Director, Registration Division, Office of Pennsylvania Ave., NW., Washington, Pigment Blue 29 (CAS Reg. No. 57455– Pesticide Programs. DC 20460–0001; telephone number: 37–5). There were no comments [FR Doc. 04–11561 Filed 5–25–04; 8:45 am] (703) 308–0371; e-mail address: received in response to the notice of BILLING CODE 6560–50–S [email protected]. filing.

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Section 408(b)(2)(A)(i) of the FFDCA human risk. EPA has also considered of the diet) ultramarine blue, which allows EPA to establish an exemption available information concerning the showed inflammation of the GI from the requirement for a tolerance (the variability of the sensitivities of major (gastrointestinal) tract and the presence legal limit for a pesticide chemical identifiable subgroups of consumers, of siliceous stones in kidney and residue in or on a food) only if EPA including infants and children. The bladder at all dose levels were observed. determines that the tolerance is ‘‘safe.’’ nature of the toxic effects caused by Histologically, no pathological effects Section 408(b)(2)(A)(ii) of the FFDCA ultramarine blue are discussed in this were observed in rats after ingestion of defines ‘‘safe ’’ to mean that ‘‘there is a unit. Ultramarines are inorganic 100 or 1,000 ppm ultramarine blue. At reasonable certainty that no harm will pigments that are used as dyes. The higher concentrations, 10,000 and result from aggregate exposure to the color of ultramarine (blue, pink, green, 100,000 ppm, there were increased pesticide chemical residue, including red, or violet) is determined by the excretion of silica and sodium, and all anticipated dietary exposures and all ratios of the materials used to pathological effects in the kidneys, other exposures for which there is manufacture the ultramarine pigment. stomach, intestine and bladder which reliable information.’’ This includes Ultramarine blue is the manufactured could be associated with high and exposure through drinking water and in or synthetic form of naturally occurring prolonged intake of siliceous earth. residential settings, but does not include Lapis Lazuli. It was first manufactured • A developmental toxicity study occupational exposure. Section in the early 1800s. The pigment is a showed no maternal deaths at any of the 408(b)(2)(C) of the FFDCA requires EPA complex sulfurized sodium aluminum administered doses (0, 100, 1,000, to give special consideration to silicate material having an approximate 10,000, or 100,000 ppm which would be exposure of infants and children to the chemical formula of Na7Al6Si6O24S3. equivalent to 0, 0.01, 0.1, 1, or 10% of pesticide chemical residue in Ultramarine blue is obtained by the diet). Histologically, no pathological establishing a tolerance and to ‘‘ensure calcining (thoroughly roasting or effects were observed at 100 or 1,000 that there is a reasonable certainty that burning in the presence of oxygen) a ppm. At higher concentrations (10,000 no harm will result to infants and mixture of kaolin, sulfur, sodium and 100,000 ppm), there were children from aggregate exposure to the carbonate, and a source of carbon at pathological effects in the kidneys, pesticide chemical residue. . . .’’ temperatures above 700 °C. The material stomach, intestine and bladder which EPA performs a number of analyses to obtained from this process is crushed, could be associated with high and determine the risks from aggregate washed, purified, and ground. prolonged intake of siliceous earth. exposure to pesticide residues. First, Ultramarine blue is known to form a There was no significant difference in EPA determines the toxicity of rigid tetrahedra alumino-silicate litter size, fetal weights, or resorptions pesticides. Second, EPA examines framework. Ultramarine blue is between controls and dose level groups. exposure to the pesticide through food, insoluble in water and organic solvents. No malformations were observed in drinking water, and through other Ultramarine blue is stable in alkali (pH controls or the highest dose group exposures that occur as a result of 7 or greater) environments but (100,000 ppm). At the 100, 1,000, and pesticide use in residential settings. decomposes and releases hydrogen 10,000 ppm dose groups, malformations in the hind limbs were observed at a III. Inert Ingredient Definition sulfide in acidic environments. When used as a dye, it is non-migratory and ratio of 2/177, 2/146, and 1/159 fetuses, Inert ingredients are all ingredients bleed-resistant, having excellent light respectively. These malformations are that are not active ingredients as defined fastness and heat stability. not statistically significant. In both cases in 40 CFR 153.125 and include, but are where 2 pups had malformations, they not limited to, the following types of A. Toxicology Studies were from the same mother. ingredients (except when they have a The information available to the • Ultramarine blue was also shown pesticidal efficacy of their own): Agency consisted of detailed to be non-mutagenic (via Ames assay) Solvents such as alcohols and information concerning various pre- using two strains each of Salmonella hydrocarbons; surfactants such as 1981 studies conducted using typhimurium and Escherichia coli. polyoxyethylene ploymers and fatty ultramarine blue. The summaries Taken together, all of the studies acids; carriers such as clay and provided sufficient detail for Agency indicate that ultramarine blue is of low diatomaceous earth; thickeners such as evaluation. The available information or no toxicological concern. This is carrageenan and modified cellulose; consisted of the following: consistent with the fact that ultramarine wetting, spreading, and dispersing • The acute oral lethal dose (LD)50 blue is insoluble; therefore, it is likely agents; propellants in aerosol for ultramarine blue is equal to or that ultramarine blue would be poorly dispensers; microencapsulating agents; greater than 10 grams/kilogram in both absorbed by any route. The only effect and emulsifiers. The term ‘‘inert’’ is not rats and mice. of concern occurred in those groups of intended to imply nontoxicity; the • Ultramarine blue was found to be animals that were fed a diet that ingredient may or may not be a non-sensitizer in guinea pigs and non- contained 1% or 10% ultramarine blue. chemically active. Generally, EPA has irritating in rabbits. The effects that occurred are consistent exempted inert ingredients from the • In a short-term (15–day) study, with those of the body’s being over- requirement of a tolerance based on the mice were fed ultramarine blue at dose whelmed by being fed large amounts of low toxicity of the individual inert levels of 10,000 milligrams/kilogram/ a siliceous earth material, which ingredients. day (mg/kg/day) which resulted in no describes ultramarine blue, a sulfurized physiological changes or deaths. sodium aluminum silicate. IV. Toxicological Profile • In a 90–day feeding study of rats Consistent with section 408(b)(2)(D) and mice to ultramarine blue at levels B. FDA Evaluation of the FFDCA, EPA has reviewed the up to 10,000 mg/kg/day, there were no Ultramarine blue is approved by the available scientific data and other adverse effects. Food and Drug Administration as a relevant information in support of this • In another 90–day feeding color additive in cosmetics (21 CFR action and considered its validity, studying, rats were fed 100, 1,000, 73.2725), food contact materials (21 CFR completeness and reliability and the 10,000, and 100,000 parts per million 178.3297), and salts intended for animal relationship of this information to (ppm) (equivalent to 0.01, 0.1, 1, or 10% feed (21 CFR 73.50) when used in

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accordance with the following colorant. It is used to color food-contact concerning common mechanism conditions. plastics and rubber (packaging determinations and procedures for 1. Cosmetics. Ultramarine pigments materials), toys, cosmetics including eye cumulating effects from substances including ultramarine blue may be shadows and eye pencils, wallpaper, found to have a common mechanism on safely used for coloring externally paints including children’s fingerpaints, EPA’s website at http://www.epa.gov/ applied cosmetics, including cosmetics modeling clays, tile, cement, animal pesticides/cumulative/. intended for use in the area of the eye. eartags, and salt intended for animal VII. Additional Safety Factor for These pigments are exempt from feed. Given its use as a colorant the Infants and Children certification. amount of ultramarine blue that would 2. Food contact materials. be incorporated into any product is FFDCA section 408 provides that EPA Ultramarine blue can be used as limited by the need for a certain shade shall apply an additional tenfold margin ‘‘colorants in the manufacture of articles or hue of blue. of safety for infants and children in the or components of articles intended for case of threshold effects to account for use in producing, manufacturing, A. Dietary Exposure prenatal and postnatal toxicity and the packing, processing, preparing, treating, 1. Food. Due to the insolubility of completeness of the data base unless packaging, transporting, or holding ultramarine blue, it is not likely to be EPA concludes that a different margin of food.’’ In this context ‘‘colorant means absorbed by any route. The available safety will be safe for infants and a dye, pigment, or other substance that toxicity information indicates that children. In a developmental toxicity is used to impart color or to alter the ultramarine blue is of low or no study, female rats were fed ultramarine color of a food-contact material, but that toxicological concern. blue before and during pregnancy which does not migrate to food in amounts that 2. Drinking water exposure. resulted in no statistically significant will contribute to that food any color Ultramarine blue is likely to absorb malformations and no difference apparent to the naked eye.’’ tightly to soil and not migrate to bodies between fetuses in the control and 3. Animal feeds. Ultramarine blue can of water. Due to the insolubility of highest dose group. Due to the lack of be used to color salt intended for ultramarine blue, it is highly unlikely absorption by all routes of exposure and ‘‘animal feed subject to the restriction that it would be found in drinking the expected low toxicity of ultramarine that the quantity of ultramarine blue water. blue, EPA has not used a safety factor does not exceed 0.5% by weight of the analysis to assess the risk. For the same B. Other Non-Occupational Exposure salt.’’ Ultramarine blue is exempt from reasons the additional tenfold safety certification. Ultramarine blue has many non-food factor is unnecessary. uses including use in: Food-contact V. Aggregate Exposures plastics and rubber (packaging VIII. Determination of Safety In examining aggregate exposure, materials), toys, cosmetics including eye The available information indicates section 408 of the FFDCA directs EPA shadows and eye pencils, wallpaper, that ultramarine blue is insoluble in to consider available information paints including children’s fingerpaints, water and is not readily absorbed by any concerning exposures from the pesticide modeling clays, tile, cement, animal route of exposure. The only effects residue in food and all other non- eartags, and salt intended for animal noted in any of the studies were effects occupational exposures, including feed. consistent to those of other siliceous drinking water from ground water or earth materials. The available toxicity VI. Cumulative Effects surface water and exposure through information indicates that ultramarine pesticide use in gardens, lawns, or Section 408 (b)(2)(D)(v) of FFDCA blue is of low or no toxicological buildings (residential and other indoor requires that, when considering whether concern. Additionally, given its use as uses). to establish, modify, or revoke a a colorant, the amount of ultramarine EPA establishes exemptions from the tolerance or tolerance exemption, the blue that would be incorporated into requirement of a tolerance only in those Agency consider ‘‘available any pesticide product is limited by the cases where it can be clearly information’’ concerning the cumulative need for a certain shade or hue of blue. demonstrated that the risks from effects of a particular chemical’s Therefore, EPA concludes that use of aggregate exposure to pesticide residues and ‘‘other substances that ultramarine blue in pesticide products chemical residues under reasonably have a common mechanism of toxicity.’’ as a colorant is not likely to pose a foreseeable circumstances will pose no Unlike other pesticides for which EPA dietary risk under reasonably appreciable risks to human health. In has followed a cumulative risk approach foreseeable circumstances. There is a order to determine the risks from based on a common mechanism of reasonable certainty of no harm to the aggregate exposure to pesticide inert toxicity, EPA has not made a common general population, including infants ingredients, the Agency considers the mechanism of toxicity finding as to and children, from aggregate exposure toxicity of the inert in conjunction with ultramarine blue and any other to residues of ultramarine blue. possible exposure to residues of the substances and ultramarine blue does IX. Other Considerations inert ingredient through food, drinking not appear to produce a toxic metabolite water, and through other exposures that produced by other substances. For the A. Analytical Method(s) occur as a result of pesticide use in purposes of this tolerance action, An analytical method is not required residential settings. If EPA is able to therefore, EPA has not assumed that for enforcement purposes since the determine that a finite tolerance is not ultramarine blue has a common Agency is establishing an exemption necessary to ensure that there is a mechanism of toxicity with other from the requirement of a tolerance reasonable certainty that no harm will substances. For information regarding without any numerical limitation. result from aggregate exposure to the EPA’s efforts to determine which inert ingredient, an exemption from the chemicals have a common mechanism B. Existing Exemptions requirement of a tolerance may be of toxicity and to evaluate the There is an existing tolerance established. cumulative effects of such chemicals, exemption in 40 CFR 180.930, formerly Ultramarine blue has been used see the policy statements released by 180.1001(e), for ultramarine blue when world-wide for many years as a EPA’s Office of Pesticide Programs used as a dye in animal ear tags.

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C. International Tolerances A. What Do I Need to Do to File an 5697, by e-mail at Objection or Request a Hearing? [email protected], or by mailing a The Agency is not aware of any request for information to Mr. Tompkins country requiring a tolerance for You must file your objection or request a hearing on this regulation in at Registration Division (7505C), Office ultramarine nor have any CODEX of Pesticide Programs, Environmental maximum residue levels been accordance with the instructions provided in this unit and in 40 CFR part Protection Agency, 1200 Pennsylvania established for any food crops at this Ave., NW., Washington, DC 20460– time. 178. To ensure proper receipt by EPA, you must identify docket ID number 0001. If you would like to request a waiver D. List 4A (Minimal Risk) Classification OPP–2004–0056 in the subject line on of the tolerance objection fees, you must the first page of your submission. All The Agency established 40 CFR mail your request for such a waiver to: requests must be in writing, and must be 180.950 (see the rationale in the James Hollins, Information Resources proposed rule published January 15, mailed or delivered to the Hearing Clerk and Services Division (7502C), Office of 2002 (67 FR 1925) (FRL–6807–8)), to on or before July 26, 2004. Pesticide Programs, Environmental 1. Filing the request. Your objection collect the tolerance exemptions for Protection Agency, 1200 Pennsylvania must specify the specific provisions in those substances classified as List 4A, Ave., NW., Washington, DC 20460– i.e., minimal risk substances. As part of the regulation that you object to, and the 0001. evaluating an inert ingredient and grounds for the objections (40 CFR 3. Copies for the Docket. In addition establishing the tolerance exemption, 178.25). If a hearing is requested, the to filing an objection or hearing request the Agency determines the chemical’s objections must include a statement of with the Hearing Clerk as described in list classification. Given the available the factual issues(s) on which a hearing Unit VIII.A., you should also send a information which indicates that is requested, the requestor’s contentions copy of your request to the PIRIB for its ultramarine blue is insoluble in water on such issues, and a summary of any inclusion in the official record that is and is not readily absorbed by any route evidence relied upon by the objector (40 described in Unit I.B.1. Mail your of exposure, ultramarine blue (CAS Reg. CFR 178.27). Information submitted in copies, identified by docket ID number No. 57455–37–5) is to be classified as a connection with an objection or hearing OPP–2004–0056, to: Public Information List 4A inert ingredient. request may be claimed confidential by and Records Integrity Branch, marking any part or all of that Information Resources and Services X. Conclusions information as CBI. Information so Division (7502C), Office of Pesticide marked will not be disclosed except in Based on the information in this Programs, Environmental Protection accordance with procedures set forth in preamble, EPA concludes that there is a Agency, 1200 Pennsylvania Ave., NW., 40 CFR part 2. A copy of the reasonable certainty of no harm from Washington, DC 20460. In person or by information that does not contain CBI aggregate exposure to residues of courier, bring a copy to the location of must be submitted for inclusion in the ultramarine blue (CAS Reg. No. 57455– the PIRIB described in Unit I.B.1. You public record. Information not marked 37–5). Accordingly, EPA finds that may also send an electronic copy of confidential may be disclosed publicly exempting ultramarine blue from the your request via e-mail to: opp- by EPA without prior notice. requirement of a tolerance will be safe. [email protected]. Please use an ASCII Mail your written request to: Office of file format and avoid the use of special Since the tolerance exemption is the Hearing Clerk (1900C), characters and any form of encryption. established under 40 CFR 180.950, the Environmental Protection Agency, 1200 Copies of electronic objections and existing tolerance exemption in 40 CFR Pennsylvania Ave., NW., Washington, hearing requests will also be accepted 180.930 is a duplication, and will be DC 20460–0001. You may also deliver on disks in WordPerfect 6.1/8.0 or removed. your request to the Office of the Hearing ASCII file format. Do not include any XI. Objections and Hearing Requests Clerk in Rm.104, Crystal Mall #2, 1921 CBI in your electronic copy. You may Jefferson Davis Hwy., Arlington, VA. also submit an electronic copy of your Under section 408(g) of the FFDCA, as The Office of the Hearing Clerk is open request at many Federal Depository amended by the FQPA, any person may from 8 a.m. to 4 p.m., Monday through Libraries. file an objection to any aspect of this Friday, excluding legal holidays. The regulation and may also request a telephone number for the Office of the B. When Will the Agency Grant a hearing on those objections. EPA’s Hearing Clerk is (703) 603–0061. Request for a Hearing? procedural regulations which govern the 2. Tolerance fee payment. If you file A request for a hearing will be granted submission of objections and requests an objection or request a hearing, you if the Administrator determines that the for hearings appear in 40 CFR part 178. must also pay the fee prescribed by 40 material submitted shows the following: Although the procedures in those CFR 180.33(i) or request a waiver of that There is a genuine and substantial issue regulations require some modification to fee pursuant to 40 CFR 180.33(m). You of fact; there is a reasonable possibility reflect the amendments made to the must mail the fee to: EPA Headquarters that available evidence identified by the FFDCA by the FQPA of 1996, EPA will Accounting Operations Branch, Office requestor would, if established resolve continue to use those procedures, with of Pesticide Programs, P.O. Box one or more of such issues in favor of appropriate adjustments, until the 360277M, Pittsburgh, PA 15251. Please the requestor, taking into account necessary modifications can be made. identify the fee submission by labeling uncontested claims or facts to the The new section 408(g) provides it ‘‘Tolerance Petition Fees.’’ contrary; and resolution of the factual essentially the same process for persons EPA is authorized to waive any fee issues(s) in the manner sought by the to ‘‘object’’ to a regulation for an requirement ‘‘when in the judgement of requestor would be adequate to justify exemption from the requirement of a the Administrator such a waiver or the action requested (40 CFR 178.32). tolerance issued by EPA under new refund is equitable and not contrary to section 408(d), as was provided in the the purpose of this subsection.’’ For XII. Statutory and Executive Order old FFDCA sections 408 and 409. additional information regarding the Reviews However, the period for filing objections waiver of these fees, you may contact This final rule establishes an is now 60 days, rather than 30 days. James Tompkins by phone at (703) 305– exemption from the tolerance

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requirement under FFDCA section include regulations that have List of Subjects in 40 CFR Part 180 408(d) in response to a petition ‘‘substantial direct effects on the States, Environmental protection, submitted to the Agency. The Office of on the relationship between the national Administrative practice and procedure, Management and Budget (OMB) has government and the States, or on the Agricultural commodities, Pesticides exempted these types of actions from distribution of power and and pests, Reporting and recordkeeping review under Executive Order 12866, responsibilities among the various requirements. entitled Regulatory Planning and levels of government.’’ This final rule I Therefore, 40 CFR chapter I is Review (58 FR 51735, October 4, 1993). directly regulates growers, food amended as follows: Because this rule has been exempted processors, food handlers and food from review under Executive Order retailers, not States. This action does not PART 180—[AMENDED] 12866 due to its lack of significance, alter the relationships or distribution of I this rule is not subject to Executive power and responsibilities established 1. The authority citation for part 180 continues to read as follows: Order 13211, Actions Concerning by Congress in the preemption Regulations That Significantly Affect provisions of FFDCA section 408(n)(4). Authority: 21 U.S.C. 321(q), 346a and 371. Energy Supply, Distribution, or Use (66 For these same reasons, the Agency has I 2. Section 180.950 is amended by FR 28355, May 22, 2001). This final rule determined that this rule does not have adding alphabetically to the table in does not contain any information any ‘‘tribal implications’’ as described paragraph (e) the following insert collections subject to OMB approval in Executive Order 13175, entitled ingredient to read as follows: under the Paperwork Reduction Act Consultation and Coordination with (PRA), 44 U.S.C. 3501 et seq., or impose § 180.950 Tolerance exemptions for Indian Tribal Governments (65 FR minimal risk active and inert ingredient. any enforceable duty or contain any 67249, November 6, 2000). Executive unfunded mandate as described under (e) * * * Order 13175, requires EPA to develop Title II of the Unfunded Mandates an accountable process to ensure Reform Act of 1995 (UMRA) (Public Chemical Name CAS No. ‘‘meaningful and timely input by tribal Law 104–4). Nor does it require any ***** special considerations under Executive officials in the development of regulatory policies that have tribal Order 12898, entitled Federal Actions to Ultramarine blue (C.I. Address Environmental Justice in implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Pigment Blue 29) ...... 57455–37–5 Minority Populations and Low-Income ***** Populations (59 FR 7629, February 16, Executive Order to include regulations 1994); or OMB review or any Agency that have ‘‘substantial direct effects on action under Executive Order 13045, one or more Indian tribes, on the * * * * * entitled Protection of Children from relationship between the Federal Environmental Health Risks and Safety Government and the Indian tribes, or on § 180.930 [Amended] Risks (62 FR 19885, April 23, 1997). the distribution of power and I 3. Section 180.930 is amended by This action does not involve any responsibilities between the Federal removing from the table the entry for technical standards that would require Government and Indian tribes.’’ This ultramarine blue. Agency consideration of voluntary rule will not have substantial direct Dated: May 14, 2004. consensus standards pursuant to section effects on tribal governments, on the Betty Shackleford, 12(d) of the National Technology relationship between the Federal Acting Director, Registration Division, Office Transfer and Advancement Act of 1995 Government and Indian tribes, or on the of Pesticide Programs. (NTTAA), Public Law 104–113, section distribution of power and [FR Doc. 04–11672 Filed 5–25–04; 8:45 am] 12(d) (15 U.S.C. 272 note). Since responsibilities between the Federal BILLING CODE 6560–50–S tolerances and exemptions that are Government and Indian tribes, as established on the basis of a petition specified in Executive Order 13175. under FFDCA section 408(d), such as Thus, Executive Order 13175 does not FEDERAL COMMUNICATIONS the exemption in this final rule, do not apply to this rule. COMMISSION require the issuance of a proposed rule, the requirements of the Regulatory XIII. Congressional Review Act 47 CFR Parts 1, 25, 63 and 64 Flexibility Act (RFA) (5 U.S.C. 601 et The Congressional Review Act, 5 seq.) do not apply. In addition, the [DA 04–671] U.S.C. 801 et seq., as added by the Small Agency has determined that this action Business Regulatory Enforcement International Bureau Filing System will not have a substantial direct effect (IBFS) on States, on the relationship between Fairness Act of 1996, generally provides that before a rule may take effect, the the national government and the States, AGENCY: Federal Communications or on the distribution of power and agency promulgating the rule must Commission. submit a rule report, which includes a responsibilities among the various ACTION: Final rule. levels of government, as specified in copy of the rule, to each House of the Executive Order 13132, entitled Congress and to the Comptroller General SUMMARY: In this document, the Federal Federalism (64 FR 43255, August 10, of the United States. EPA will submit a Communications Commission (FCC) 1999). Executive Order 13132 requires report containing this rule and other codifies the use of the International EPA to develop an accountable process required information to the U.S. Senate, Bureau Filing System (IBFS) as an to ensure ‘‘meaningful and timely input the U.S. House of Representatives, and official method of filing applications by State and local officials in the the Comptroller General of the United related to satellite and international development of regulatory policies that States prior to publication of this final telecommunications services with the have federalism implications.’’ ‘‘Policies rule in the Federal Register. This final Commission. In addition, this document that have federalism implications’’ is rule is not a ‘‘major rule’’ as defined by modifies the Commission Rules to defined in the Executive Order to 5 U.S.C. 804(2). reflect mandatory electronic filing

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requirements adopted in the First Space • Routine Earth Station Applications. 1.9008 What are IBFS file numbers? Station Reform Order and the Third The International Bureau wrote the 1.9009 What are the steps for electronic Space Station Reform Order. In doing new and amended rules in plain filing? so, we amend the Commission’s rules to language pursuant to Executive Order 1.9010 Do I need to send paper copies with 12866. my electronic applications? accommodate electronic filing via IBFS. 1.9011 Who may sign applications? Electronic filing has proven to improve List of Subjects 1.9012 When can I file on IBFS? the speed and efficiency of application 1.9013 How do I check the status of my processing and also to expedite the 47 CFR Part 1 application after I file it? availability of application information Administrative practice and 1.9014 What happens after officially filing for public use and inspection. procedure, Reporting and recordkeeping my application? DATES: Effective May 19, 2004. 1.9015 Are there exceptions for emergency requirements. filings? FOR FURTHER INFORMATION CONTACT: 47 CFR Parts 25, 63 and 64 1.9016 How do I apply for special Jacqueline Ponti, 202–418–0436 or Mary temporary authority? Jane Solomon, 202–418–0593. Reporting and recordkeeping 1.9017 How can I submit additional SUPPLEMENTARY INFORMATION: In requirements. information? incorporating IBFS into the Code of Federal Communications Commission. 1.9018 May I amend my application? Federal Regulations, applicants now Andrew S. Fishel, Subpart Y—International Bureau Filing have assurance in the viability of their Managing Director. online filings through IBFS. System Applicants may voluntarily file the Rule Changes § 1.9000 What is the purpose of these following applications through IBFS. I For the reasons stated above, the rules? • International Accounting Rate Federal Communications Commission (a) These rules are issued under the Change Filings. Communications Act of 1934, as • Submarine Cable Landing License amends 47 CFR Parts 1, 25, 63 and 64 as amended, 47 U.S.C. 151 et seq., and the Applications. set forth below: • Requests for Assignment of Data Submarine Cable Landing License Act, PART 1—PRACTICE AND 47 U.S.C. 34–39. Network Identification Codes PROCEDURE • Foreign Carrier Affiliation (b) These rules allow you to file many Notification Filings. I 1. The authority citation for part 1 International and Satellite Services • International Section 214 continues to read as follows: applications electronically via the Applications. Internet using the International Bureau • Authority: 47 U.S.C. 151, 154(i), 154(j), Filing System. International Section 214 Special 155, 225, 303(r), 309 and 325(e). Temporary Authority. (c) These rules require electronic • International Signaling Point Code I 2. Section 1.767(a) is revised to read as filing of all Satellite Space Station Filings. follows: applications, except Digital Broadcast • Recognized Operating Agency Service (DBS) and Digital Audio Radio § 1.767 Cable landing licenses. Filings. Service (DARS) applications. • Renewal of Radio License in (a) Applications for cable landing (d) These rules require electronic Specific Services (except as noted in licenses under 47 U.S.C. 34–39 and filing of applications for routine earth paragraph 6). Executive Order No. 10530, dated May station applications. • Space and Earth Station 10, 1954, should be filed in accordance (e) These rules require electronic Applications (except as noted in with the provisions of that Executive filing of applications for Earth Stations paragraph 6). Order. These applications should to Access a Non-U.S. Satellite Not —Earth Station Authorizations–Form contain the information below. You may Currently Authorized to Provide the 312 file your application electronically on Proposed Service in the Proposed —Earth Station Special Temporary the Internet through the International Frequencies in the United States. Authority Bureau Filing System (IBFS) or by (f) This section describes —Space Station Authorizations–Form paper. For information on filing your requirements and conditions pertaining 312 application through IBFS, see part 1, to electronic filing. —Space Station Special Temporary subpart Y and the IBFS homepage at (g) More licensing and application Authority http://www.fcc.gov/ibfs. Paper descriptions and directions are in parts —Modifications of Authorization–Form applications should be filed in 1 (§ 1.767), 25, 63 (§ 63.18), and 64 of 312 duplicate. this chapter. —Amendments to Pending * * * * * § 1.9001 Definitions. Applications–Form 312 I 3. A new Subpart Y is added to read Application. A request for an earth or —Transfers of Control of License–Form as follows: 312 space station radio station license, an —Assignments of License–Form 312 Subpart Y—International Bureau Filing international cable landing license, or Applicants are required to file the System an international service authorization, following applications electronically Sec. or a request to amend a pending through IBFS. 1.9000 What is the purpose of these rules? application or to modify or renew • Space Station Applications except 1.9001 Definitions. licenses or authorizations. The term also for Digital Broadcast Service (DBS) and 1.9002 What happens if the rules conflict? includes the other requests that may be Digital Audio Radio Service (DARS). 1.9003 When can I start operating? filed in IBFS such as transfers of control • 1.9004 What am I allowed to do if I am Earth Station Applications to approved? and assignments of license applications, Access a Non-U.S. Satellite Not 1.9005 What is IBFS? earth station registrations, and foreign Currently Authorized to Provide the 1.9006 Is electronic filing mandatory? carrier affiliation notifications. Proposed Service in the Proposed 1.9007 What applications can I file Authorizations. Generally, a written Frequencies in the United States. electronically? document or oral statement issued by us

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giving authority to operate or provide Satellite Space Station Applications date and time of filing (to the service. (other than DBS and DARS) and millisecond). For purposes of the queue International Bureau Filing System. Applications for Earth Stations to discussed in § 25.158 of this chapter, we The International Bureau Filing System Access a Non-U.S. Satellite Not will base the order of the applications (IBFS) is a database, application filing Currently Authorized to Provide the in the queue on the date and time the system, and processing system for all Proposed Service in the Proposed applications are filed, rather than the International and Satellite services. Frequencies in the United States. We ‘‘Official Filing Date’’ as defined here. IBFS supports electronic filing of many consider a Satellite Space Station All Other Applications. We consider applications and related documents in application (other than DBS and DARS) all other applications officially filed the International Bureau, and provides and an Application for an Earth Station once you file the application in IBFS public access to this information. to Access a Non-U.S. Satellite Not and applicable filing fees are received Currently Authorized to Provide the and approved by the FCC, unless the International Services. All Proposed Service in the Proposed application is determined to be fee- international services authorized under Frequencies in the United States exempt. We determine your official parts 1, 63 and 64 of this chapter. officially filed the moment you file them filing date based on one of the following Official Filing Date. through IBFS. The system tracks the situations:

1. You file your Satellite Space Station Application (other than DBS Your official filing date is the date and time (to the millisecond) and DARS) or your Application for Earth Stations to Access a you file your application and receive a confirmtion of filing and Non-U.S. Satellite Not Currently Authorized to provide the Pro- submission ID. posed Service in the Proposed Frequencies in the United States in IBFS. 2. You file all other applications in IBFS and then do one of the fol- Your official filing date is: lowing:. Send your payment (via check, bank draft, money order, credit card, The date Mellon Bank stamps your payment as received. or wire transfer) and FCC Form 159 to Mellon Bank. Pay by online credit card (through IBFS)...... The date your online credit card payment is approved. (Note: you will receive a remittance ID and an authorization number if your transaction is successful). Determine your application type is fee-exempt or your application The date you file in IBFS and receive a confirmation of filing and qualifies for exemption to charges as provided in Part 1 of the submission ID. Commission’s Rules.

Satellite Services. All satellite services § 1.9004 What am I allowed to do if I am § 1.9007 What applications can I file authorized under part 25 of this chapter. approved? electronically? Submission ID. The Submission ID is If you are approved and receive a (a) You can file most International the confirmation number you receive license or authorization, you must and Satellite applications electronically. In cases where a paper form exists, we from IBFS once you have successfully operate in accordance with, and not attempted to keep the same format for filed your application. It is also the beyond, your terms of approval. the online version of the form. In some number we use to match your filing to § 1.9005 What is IBFS? cases (such as International Section 214 your payment. Your IBFS Submission (a) The International Bureau Filing applications filed under § 63.18), ID will always start with the letters ‘‘IB’’ although a paper form does not exist, and include the year in which you file System (IBFS) is a database, application filing system, and processing system for there is an electronic form to facilitate as well as a sequential number, (e.g., all International and Satellite Services. filing. IB2003000123). IBFS supports electronic filing of many (b) The following applications are Us. In this subpart, ‘‘us’’ refers to the applications and related documents in available on IBFS for electronic filing: Commission. the International Bureau, and provides (1) International Accounting Rate We. In this subpart, ‘‘we’’ refers to the public access to this information. Change Filings, (2) Submarine Cable Landing License Commission. (b) We maintain applications, notifications, correspondence, and other Applications, You. In this subpart, ‘‘you’’ refers to (3) Requests for Assignment of Data applicants, licensees, your materials filed electronically with the International Bureau in IBFS. Network Identification Codes, representatives, or other entities (4) Foreign Carrier Affiliation authorized to provide services. § 1.9006 Is electronic filing mandatory? Notification Filings, Electronic filing is mandatory for: (5) International Section 214 § 1.9002 What happens if the rules Applications, conflict? (a) Satellite license applications other (6) International Section 214 Special The rules concerning parts 1, 25, 63 than DBS and DARS applications, Temporary Authority, and 64 of this chapter govern over the (b) Applications for earth stations to (7) International Signaling Point Code electronic filing in this subpart. access a non-U.S. satellite not currently Filings, authorized to provide the proposed (8) Recognized Operating Agency § 1.9003 When can I start operating? service in the proposed frequencies in Filings, the United States, and You can begin operating your facility (9) Renewal of Radio License in or providing services once we grant (c) Routine earth station applications. Specific Services, and your application to do so, under the Except for these applications, electronic (10) Space and Earth Station filing is voluntary at this time. However, Applications conditions set forth in your license or we encourage you to use IBFS to (i) Earth Station Authorizations— authorization. increase time-savings and efficiency. Form 312

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(ii) Earth Station Special Temporary (2) In order to complete and file your determine the amount of your fee in Authority electronic application, you must register three ways: (iii) Space Station Authorizations— in IBFS, located at http://www.fcc.gov/ (i) You can refer to § 1.1107, Form 312 ibfs. (ii) You can refer to the International (iv) Space Station Special Temporary (3) You can register your account in: and Satellite Services fee guide located Authority (i) Your name, at http://www.fcc.gov/fees/appfees.html, (v) Modifications of Authorization— (ii) Your company’s name, or or Form 312 (iii) Your client’s name. (vi) Amendments to Pending (4) IBFS will issue you an account (iii) You can run a draft Form 159 Applications—Form 312 number as part of the registration through IBFS, in association with a filed (vii) Transfers of Control of License— process. You will create your own application, and the system will Form 312 password. automatically enter your required fee on (viii) Assignments of License—Form (5) If you forget your password, send the form. 312 an e-mail to the IBFS helpline at (2) A complete FCC Form 159 must (c) Many applications require exhibits [email protected] or contact the helpline accompany all fee payments. You must or attachments. If attachments are at (202) 418–2222 for assistance. provide the FRN for both the applicant required, you must attach (c) Step 3: Log into IBFS, select the and the payer. You also must include documentation to your electronic application you want to file, provide the your IBFS Submission ID number on application before filing. We accept required FRN(s) and password(s) and your FCC Form 159 in the box labeled attachments in the following formats: fill out your application. You must ‘‘FCC Code 2.’’ In addition, for Word, Adobe Acrobat, Excel and Text. completely fill out forms and provide all applications for transfer of control or (d) For paper filing rules and requested information as provided in assignment of license, call signs procedures, see parts 1, 25, 63 or 64. parts 1, 25, 63 and 64 of this chapter. involved in the transaction must be (1) You must provide an address entered into the ‘‘FCC Code 1’’ box on § 1.9008 What are IBFS file numbers? where you can receive mail delivery by the FCC Form 159. (This may require (a) We assign file numbers to the United States Postal Service. You the use of multiple rows on the FCC electronic applications in order to are also encouraged to provide an e-mail Form 159 for a single application where facilitate processing. address. This information is used to more than one call sign is involved.) (b) We only assign file numbers for contact you regarding your application (i) You may use a paper version of administrative convenience; they do not and to request additional FCC Form 159, or mean that an application is acceptable documentation, if necessary. for filing. (2) Reference to material on file. You (ii) You can generate a pre-filled FCC (c) For a description of file number must answer questions on application Form 159 from IBFS using your IBFS information, see The International forms that call for specific technical Submission ID. For specific instructions Bureau Filing System File Number data, or that require yes or no answers on using IBFS to generate your FCC Format Public Notice, DA–04–568 or other short answers. However, if Form 159, go to the IBFS Web site (released February 27, 2004). documents or other lengthy showings (http://www.fcc.gov/ibfs) and click on are already on file with us and contain the ‘‘Getting Started’’ button. § 1.9009 What are the steps for electronic the required information, you may (3) You have 3 payment options: filing? incorporate the information by (i) Pay by credit card (through IBFS or (a) Step 1: Register for an FCC reference, as long as: by regular mail), Registration Number (FRN). (See (i) The referenced information is filed Subpart W, §§ 1.8001 through 1.8004.) in IBFS or, if manually filed, the (ii) Pay by check, bank draft or money order, or (1) If you already have an FRN, go to information is more than one ‘‘81⁄2 inch Step 2. by 11 inch’’ page. (iii) Pay by wire transfer or other (2) In order to process your electronic (ii) The referenced information is electronic payments. application, you must have an FRN. You current and accurate in all material (4) You have 14 calendar days from may obtain an FRN either directly from respects; and the date you file your application in the Commission Registration System (iii) The application states where we IBFS to submit your fee payment to (CORES) at http://www.fcc.gov/e-file/, or can find the referenced information as Mellon Bank. Your FCC Form 159 must through IBFS as part of your filing well as: be stamped ‘‘received’’ by Mellon Bank process. If you need to know more about (A) The application file number, if the by the 14th day. If not, we will dismiss who needs an FRN, visit CORES at reference is to previously-filed your application. http://www.fcc.gov/e-file/. applications (5) If you send your Form 159 and (3) If you are a(n): (B) The title of the proceeding, the payment to Mellon Bank in paper form, (i) Applicant, docket number, and any legal citation, you should mail your completed Form (ii) Transferee and assignee, if the reference is to a docketed 159 and payment to the address (iii) Transferor and assignor, proceeding. specified in § 1.1107 of the (iv) Licensee/Authorization Holder, or (a) Step 4. File your application. If Commission’s rules. If you file (v) Payer, you are required to have you file your application successfully electronically, do not send copies of and use an FRN when filing through IBFS, a confirmation screen your application with your payment and applications and/or paying fees through will appear showing you the date and Form 159. IBFS. time of your filing and your submission (4) We use your FRN to give you ID. Print this verification for your (6) For more information on fee secured access to IBFS and to pre-fill records as proof of online filing. payments, refer to Payment Instructions the application you file. (b) Step 5: Pay for your application. found on the IBFS Internet site at http:/ (a) Step 2: Register with IBFS. (1) Most applications require that you /www.fcc.gov/ibfs. (1) If you are already registered with pay a fee to us before we can begin (7) Step 5 is not applicable if your IBFS, go to Step 3. processing your application. You can application is fee exempt.

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§ 1.9010 Do I need to send paper copies (e) If you file applications, § 1.9014 What happens after officially with my electronic applications? amendments, and related statements of filing my application? (a) If you file electronically through fact on behalf of eligible government (a) We give you an IBFS file number. IBFS, the electronic record is the official entities, an elected or appointed official (b) We electronically route your record. who may sign under the laws of the application to an analyst who conducts (b) If you file electronically, you do applicable jurisdiction must sign the an initial review of your application. If not need to submit paper copies of your document. Eligible government entities your application is incomplete, we will application. are: (1) States and territories of the United either dismiss the application, or (c) If you submit paper copies of your contact you by telephone, letter or email application with your payment, we will States, (2) Political subdivisions of these to ask for additional information within consider them as copies and may not a specific time. In cases where we ask retain them. states and territories, (3) The District of Columbia, and for additional information, if we do not § 1.9011 Who may sign applications? (4) Units of local government. receive it within the specified time, we (f) If you are either physically will dismiss your application. In either (a) ‘‘Signed’’ in this section refers to disabled or absent from the United case, we will dismiss your application electronically filed applications. An States, your attorney may sign without prejudice, so that you may file electronic application is ‘‘signed’’ when applications, amendments and related again with a complete application. there is an electronic signature. An statements of facts on your behalf. (c) If your application is complete, electronic signature is the typed name of (1) Your attorney must explain why and we verify receipt of your payment, the person ‘‘signing’’ the application, you are not signing the documents. which is then electronically transmitted (2) If your attorney states any matter it will appear on an ‘‘Accepted for via IBFS. based solely on his belief (rather than Filing’’ Public Notice, unless public (b) For all electronically filed knowledge), your attorney must explain notice is not required. An ‘‘Accepted for applications, you (or the signor) must his reasons for believing that such Filing’’ Public Notice gives the public a actually sign a paper copy of the statements are true. certain amount of time to comment on application, and keep the signed (g) It is unnecessary to sign your filing. This period varies original in your files for future applications, amendments, and related depending upon the type of application. reference. statements of fact under oath. However, (1) Certain applications do not have to (c) You only need to sign the original willful false statements are punishable go on an ‘‘Accepted for Filing’’ Public of applications, amendments, and by a fine and imprisonment, 18 U.S.C. Notice prior to initiation of service, but related statements of fact. 1001, and by administrative sanctions. instead are filed as notifications to the (d) Sign applications, amendments, Commission of prior actions by the § 1.9012 When can I file on IBFS? and related statements of fact as follows carriers as authorized by the rules. (either electronically or manually): IBFS is available 24 hours a day, Examples include pro forma (1) By you, if you are an individual; seven (7) days a week for filing. notifications of transfer of control and (2) By one of the partners, if you are § 1.9013 How do I check the status of my assignment and certain foreign carrier a partnership; application after I file it? notifications. (3) By an officer, director, or duly You can check the status of your (2) Each ‘‘Accepted for Filing’’ Public authorized employee, if you are a application through the ‘‘Search Tools’’ Notice has a report number. Examples of corporation; or on the IBFS homepage. The IBFS various types of applications and their (4) By a member who is an officer, if homepage is located at www.fcc.gov/ corresponding report number (the ‘‘x’’ you are an unauthorized association. ibfs. represents a sequential number) follow.

Type of application Report No.

325–C Applications ...... 325–xxxxx Accounting Rate Change ...... ARC–xxxxx Foreign Carrier Affiliation Notification ...... FCN–xxxxx International High Frequency ...... IHF–xxxxx International Public Fixed ...... IPF–xxxxx Recognized Operating Agency ...... ROA–xxxxx Satellite Space Station ...... SAT–xxxxx Satellite Earth Station ...... SES–xxxxx International Telecommunications: Streamlined ...... TEL–xxxxxS Non-streamlined ...... TEL–xxxxxNS and/or DA Submarine Cable Landing: Streamlined ...... SCL–xxxxxS Non-streamlined ...... SCL–xxxxxNS and/or DA

(d) After the Public Notice, your take other necessary action. Grants, Accounting Rate Change Filings and application may undergo legal, denials and any other necessary actions Requests for assignment of Data technical and/or financial review as are noted in the IBFS database. Some Network Identification Codes, may be deemed necessary. In addition, some filings may not require any affirmative granted automatically on a specific date applications require coordination with action, such as some Foreign Carrier unless the applicant is notified other government agencies. Affiliation Notification Filings. Other otherwise prior to that date, as specified (e) After review, we decide whether to filings, such as some International in the rules. grant or deny applications or whether to Section 214 Applications, International

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(f) We list most actions taken on Examples of various types of report number (the ‘‘x’’ represents a public notices. Each ‘‘Action Taken’’ applications and their corresponding sequential number) follow. Public Notice has a report number.

Type of application Report No.

325–C Applications ...... 325–xxxxx Accounting Rate Change ...... No action taken PN released Foreign Carrier Affiliation Notification ...... No action taken PN released International High Frequency ...... IHF–xxxxx International Public Fixed ...... IPF–xxxxx Recognized Operating Agency ...... No action taken PN released Satellite Space Station ...... SAT–xxxxx (occasionally) Satellite Earth Station ...... SES–xxxxx International Telecommunications ...... TEL–xxxxx and DA Submarine Cable Landing ...... TEL–xxxxx and DA

(g) Other actions are taken by formal cases, the action dates are available granted by the Commission result in the written Order, oral actions that are online through the IBFS system. issuance of a paper license or followed up with a written document, (h) Issuing and Mailing Licenses for authorization. A list of application types or grant stamp of the application. In all Granted Applications. Not all and their corresponding authorizations applications handled through IBFS and follows.

Type of application Type of license/authorization issued

325–C Application ...... FCC permit mailed to permittee or contact, as specified in the applica- tion. Accounting Rate Change ...... No authorizing document is issued by the Commission. In some cases, a Commission order may be issued related to an Accounting Rate Change filing. Data Network Identification Code Filing ...... Letter confirming the grant of a new DNIC or the reassignment of an existing DNIC is mailed to the applicant or its designated representa- tive. Foreign Carrier Affiliation Notification ...... No authorizing document is issued by the Commission. In some cases, a Commission order may be issued related to a Foreign Carrier Af- filiation Notification. International High Frequency: Construction Permits, ...... For all applications, an original, stamped authorization is issued to the Licenses, applicant and a copy of the authorization is sent to the specified Modifications, contact. Renewals, and Transfers of Control/Assignment of License International Public Fixed: 1. Construction Permits ...... 1. Once the operating license is granted, the construction period there- in is specified as a condition on the license. 2. Request for Special Temporary Authority ...... 2. Letter, grant-stamped request, or short order. 3. New Authorization ...... 3. License issued and mailed to applicant (original) and specified con- tact (copy). 4. Amendment ...... 4. If granted, the action is incorporated into the license for the under- lying application. 5. Modification ...... 5. License issued and mailed to applicant (original) and specified con- tact (copy). 6. Renewal ...... 6. License issued and mailed to applicant (original) and specified con- tact (copy). 7. Transfer of Control/Assignment of License ...... 7. If granted, Form A–732 authorization issued and mailed to applicant (original), parties to the transaction, and the applicant’s specified contact (copy). Recognized Operating Agency ...... The FCC sends a letter to the Department of State requesting grant or denial of recognized operating agency status. (The applicant is mailed a courtesy copy.) The Department of State issues a letter to both the Commission and the Applicant advising of their decision. Satellite Space Station: 1. Request for Special Temporary Authority ...... 1. Letter, grant-stamped request, or short order. 2. New Authorization ...... 2. Generally issued by Commission Order. 3. Amendment ...... 3. Generally issued as part of a Commission Order acting upon the un- derlying application. 4. Modification ...... 4. Generally issued by Commission Order. 5. Transfer of Control/Assignment of License ...... 5. Generally issued by Commission Order or Public Notice. Also, Form A–732 authorization issued and mailed to applicant (original), parties to the transaction, and the applicant’s specified contact (copy). Satellite Earth Station: 1. Request for Special Temporary Authority ...... 1. Letter, grant-stamped request, or short order.

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Type of application Type of license/authorization issued

2. New Authorization ...... 2. License issued and mailed to applicant (original) and specified con- tact (copy). 3. Amendment ...... 3. If granted, the action is incorporated into the license for the under- lying application. 4. Modification ...... 4. License issued and mailed to applicant (original) and specified con- tact (copy). 5. Renewal ...... 5. License issued and mailed to applicant (original) and specified con- tact (copy). 6. Transfer of Control/Assignment of License ...... 6. If granted, Form A–732 authorization issued and mailed to applicant (original), parties to the transaction, and the applicant’s specified contact (copy). International Telecommunications—Section 214: 1. Streamlined (New, Transfer of Control, Assignment) ...... 1. Action Taken Public Notice serves as the authorization document. This notice is issued weekly and is available online both at IBFS (http://www.fcc.gov/ibfs) and the Electronic Document Management System (EDOCS) (http://www.fcc.gov/e-file/). 2. Non-streamlined (New, Transfer of Control, Assignment) ...... 2. Decisions are generally issued by PN; some are done by Commis- sion Order. 3. Request for Special Temporary Authority ...... 3. Letter, grant-stamped request issued to applicant. International Signaling Point Code Filing ...... Letter issued to applicant. Submarine Cable Landing License Application: 1. Streamlined (New, Transfer of Control, Assignment) ...... 1. Action Taken Public Notice serves as the authorization document. This notice is issued weekly and is available online both at IBFS, which can be found at http://www.fcc.gov/ibfs, and the Electronic Document Management System (EDOCS), which can be found at http://www.fcc.gov/e-file/. 2. Non-Streamlined (New, Transfer of Control, Assignment) ...... 2. Decisions are generally issued by PN; some are done by Commis- sion Order.

§ 1.9015 Are there exceptions for will ensure faster receipt of your § 25.110 Filing of Applications, fees, and emergency filings? request. number of copies. (a) Sometimes we grant licenses, (b) For specific information on the (a) You can obtain application forms modifications or renewals even if no content of your request, refer to for this part by: one files an application. Instances §§ 25.120 and 63.25 of this chapter. (1) Going online at http:// where this may occur include: www.fcc.gov/ibfs, where you may (1) If we find there is an emergency § 1.9017 How can I submit additional complete the form prior to submission involving danger to life or property, or information? via IBFS, the IB electronic filing system; because equipment is damaged; In response to an official request for (2) Going online at http://www.fcc.gov (2) If the President proclaims, or if information from the International and clicking the Forms link to Congress declares, a national Bureau, you can submit additional download and print the form prior to emergency; information electronically directly to completion; (3) Writing to the Federal (3) During any war in which the the requestor, or by mail to the Office Communications Commission, Forms United States is engaged and when of the Secretary, Attention: International Distribution Center, 9300 E. Hampton grants, modifications or renewals are Bureau. necessary for national defense, security Drive, Capital Heights, MD 20743; or or in furtherance of the war effort; or § 1.9018 May I amend my application? (4) Calling 1 (800) 418–3676. (4) If there is an emergency where we (b) Submitting your application—(1) (a) If the service rules allow, you may Electronic filing. All Satellite Space find that it is not feasible to secure amend pending applications. renewal applications from existing Station applications, with the exception licensees or to follow normal licensing (b) If an electronic version of an of DBS and DARS, and applications for procedures. amendment application is available in Earth Stations to Access a Non-U.S. (b) Emergency authorizations stop at IBFS, you may file your amendment Satellite Not Currently Authorized to the end of emergency periods or wars. electronically through IBFS. Provide the Proposed Service in the After the emergency period or war, you Proposed Frequencies in the United PART 25—SATELLITE must submit your request by filing the States, must be filed electronically in COMMUNICATIONS appropriate form either manually or accordance with First Report and Order electronically. and Further Notice of Proposed I (c) The procedures for emergency 4. The authority citation for part 25 Rulemaking (IB Docket No. 02–34) and requests, as described in this section, continues to read as follows: First Report and Order (IB Docket No. are as specified in §§ 25.120 and 63.25 Authority: 47 U.S.C. 701–744. Interprets or 02–54) (FCC 03–102). All other satellite of this chapter. applies Sections 4, 301, 302, 303, 307, 309, radio station applications may be filed and 332 of the Communications Act, as electronically or manually. § 1.9016 How do I apply for special amended, 47 U.S.C. Sections 154, 301, 302, (2) Manual filing. Manually filed temporary authority? 303, 307, 309 and 332, unless otherwise satellite radio station applications (a) Requests for Special Temporary noted. requiring a fee, must be submitted to the Authority (STA) may be filed via IBFS address specified in part 1, subpart G of for most services. We encourage you to I 5. Section 25.110 is revised to read as this chapter. You must submit all other file STA applications through IBFS as it follows: applications to the Office of the

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Secretary, Federal Communications provisions of part 1, subpart Y of this (d) Transfer of control of corporation Commission, 445 12th Street, SW., chapter. holding license. If you want to transfer Washington, DC 20554. * * * * * control of a corporation, which holds (c) All your correspondence and I 7. Section 25.115 is amended by one or more licenses voluntarily or amendments concerning your revising paragraph (a) to read as follows: involuntarily (de jure or de facto), you application must identify: must submit an FCC Form 312, Main (1) The satellite radio service; § 25.115 Application for earth station Form and Schedule A. You must file (2) The applicant’s name; authorizations. these forms electronically through IBFS. (3) Station location; (a) Transmitting earth stations. Except For involuntary transfers, you must file (4) The call sign or other as provided under 25.113(b) of this your application within 10 days of the identification of the station; and chapter, Commission authorization event causing the transfer of control. (5) The file number of the application must be obtained for authority to You can also use FCC Form 312, Main involved. construct and/or operate a transmitting Form and Schedule A for non- (d) Copies. If you file electronically earth station. Applications shall be filed substantial (pro forma) transfers of though IBFS, you do not need to submit on FCC Form 312, Main Form and control. any paper versions of your application Schedule B, and include the * * * * * (original or copies) with your payment. information specified in § 25.130. In I (1) If you file Digital Broadcast 9. Section 25.130 is amended by cases where an application is for a revising paragraph (a) to read as follows: Service and Digital Audio Radio Service transmitting earth station facility that paper applications, you must submit the will transmit in the 3700–4200MHz and § 25.130 Filing requirements for original and nine (9) copies. 5925–6425 MHz band, and/or the 11.7– transmitting earth stations. (2) If you file anything else on paper, 12.2 GHz and 14.0–14.5 GHz band, and (a) If you want to apply for a new or including applications, exhibits, will meet all the applicable technical modified transmitting earth station attachments, amendments and specifications set forth in part 25 of this facility, you must file FCC Form 312, correspondence, you must submit the chapter, the application must be filed Main Form, and Schedule B. See original and 3 copies. electronically through the International § 25.115 for the transmitting earth (e) Signing. If you submit your Bureau Filing System (IBFS). station applications which must be filed application electronically, upon filing, Applications for Earth Stations to electronically through IBFS versus those you must print out the filed application, Access a Non-U.S. Satellite Not that are permitted but not required to be obtain the proper signatures, and keep Currently Authorized to Provide the filed electronically. the original for your files. (1) If you submit a paper application, Proposed Service in the Proposed * * * * * you must sign it in accordance with Frequencies in the United States also I 10. Section 25.131 is amended by § 1.743 of this chapter. must be filed electronically through revising paragraph (a) to read as follows: (2) You may conform all other copies. IBFS. Applications for other earth station applications are permitted but § 25.131 Filing requirements for receive- (f) You must pay the appropriate fee only earth stations. for your application and submit it in not required to be filed electronically. Any party choosing to file an earth (a) If you want to apply for a license accordance with subpart G of part 1 of for a receive-only earth station, you this chapter. station application electronically must file in accordance with the applicable must file FCC Form 312, Main Form and I 6. Section 25.114 is amended by provisions of part 1, subpart Y of this Schedule B. You can either file this revising paragraph (b) to read as follows: chapter. application on paper or electronically through IBFS. § 25.114 Applications for space station * * * * * * * * * * authorizations. I 8. Section 25.119 is amended by * * * * * revising paragraphs (a), (c), and (d) to PART 63—EXTENSION OF LINES, NEW (b) Each application for a new or read as follows: LINES, AND DISCONTINUANCE, modified space station authorization REDUCTION, OUTAGE AND must constitute a concrete proposal for § 25.119 Assignment or transfer of control IMPAIRMENT OF SERVICE BY Commission evaluation. Each of station authorization. COMMON CARRIERS; AND GRANTS application must also contain the formal (a) You must file an application for OF RECOGNIZED PRIVATE waiver required by Section 304 of the Commission authorization before you OPERATING AGENCY STATUS Communications Act, 47 U.S.C. 304. can transfer, assign, dispose of The technical information for a (voluntarily or involuntarily, directly or I 11. The authority citation for part 63 proposed satellite system specified in indirectly, or by transfer of control of continues to read as follows: paragraph (c) of this section must be any corporation or any other entity) your station license or accompanying Authority: Sections 1, 4 (i), 4 (j), 10, 11, filed on FCC Form 312, Main Form and 201–205, 214, 218, 403 and 651 of the Schedule S. The technical information rights. The Commission will grant your Communications Act of 1934 as amended, 47 for a proposed satellite system specified application only if it finds that doing so U.S.C. 151, 154 (i), 154 (j), 160, 201–205, 214, in paragraph (d) of this section need not will serve the public interest, 218, 403, and 571, unless otherwise noted. be filed on any prescribed form but convenience and necessity. I 12. Section 63.11 is amended by should be complete in all pertinent * * * * * redesignating paragraphs (g), (h), and (i) details. Applications for new space (c) Assignment of license. You must as paragraphs (h), (i), and (j) and adding station authorizations other than submit an FCC Form 312, Main Form a new paragraph (g) to read as follows: authorizations for the Direct Broadcast and Schedule A to voluntarily assign Service (DBS) and Digital Audio Radio (e.g., as by contract or other agreement) § 63.11 Notification by and prior approval Satellite (DARS) service must be filed or involuntarily assign (e.g., as by death, for U.S. international carriers that are or electronically through the International bankruptcy, or legal disability) your proposed to become affiliated with a foreign Bureau Filing System (IBFS) in station authorization. You must file carrier. accordance with the applicable these forms electronically through IBFS. * * * * *

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(g) You may file your notification by fee prescribed in subpart G of part 1 of I 17. Section 63.53 is amended by letter or by electronic form. If you this chapter. redesignating paragraphs (a) and (b) as choose to notify the Commission * * * * * paragraphs (b) and (c), and adding a new electronically, the International Bureau I 15. Section 63.25 is amended by paragraph (a) to read as follows: Filing System (IBFS) has a form that you revising paragraphs (b) and (d)(2) to read § 63.53 Form. can fill out and file on the Internet. For as follows: additional information on IBFS filing (a)(1) Applications for international procedures, refer to the rules in part 1 § 63.25 Special provisions relating to service under Section 214 of the of this chapter and the IBFS homepage temporary or emergency service by Communications Act may be filed at http://www.fcc.gov/ibfs. international carriers. electronically on the Internet through the International Bureau Filing System * * * * * * * * * * (b) Requests for immediate authority (IBFS). For applications filed through I 13. Section 63.18 is amended by for temporary service or for emergency IBFS, you are not required to send the revising the introductory text to read as service may be made electronically on original or any copies with your fee follows: the Internet through the International payment. For information on filing your § 63.18 Contents of applications for Bureau Filing System (IBFS), by letter, application through IBFS, see part 1, international common carriers. or by telegram setting forth why such subpart Y of this chapter, and the IBFS immediate authority is required, the homepage at http://www.fcc.gov/ibfs. You may submit your formal (2) Applications under section 214 of nature of the emergency, the type of application to the Commission either by the Communications Act that are not facilities proposed to be used, the route filing an electronic form via the Internet filed through IBFS shall be submitted on kilometers thereof, the terminal in IBFS or by submitting a written paper not more than 21.6cm (8.5 in) communities to be served, and airline request. The IBFS electronic form wide and not more than 35.6 cm (14 in) kilometers between such communities; allows you to fill out required long with a left-hand margin of 4 cm how these points are presently being information online and attach any (1.5 in). This requirement shall not served by the applicant or other carriers, additional information required by this apply to original documents, or the need for the proposed service, the section. For information on filing your admissible copies thereof, offered as cost involved including any rentals, the application through IBFS, see part 1, exhibits or to specifically prepared date on which the service is to begin, subpart Y and § 63.20 of this chapter, exhibits. The impression shall be on one and where known, the date or and the IBFS homepage at http:// side of the paper only and shall be approximate date on which the service www.fcc.gov/ibfs. Whether you file your double-spaced, except that long is to terminate. For information on filing request through IBFS or in paper form, quotations shall be single-spaced and your request through IBFS, see part 1, it must contain a statement explaining indented. All papers, except charts and subpart Y and § 63.20 of this chapter, how grant of the authorization will maps, shall be typewritten or prepared and the IBFS homepage at http:// serve the public interest, convenience by mechanical processing methods, www.fcc.gov/ibfs. and necessity. Such statement must other than letter press, or printed. The consist of the following information, as * * * * * foregoing shall not apply to official applicable: (d) * * * publications. All copies must be clearly * * * * * (2) Such request may be made legible. electronically on the Internet through I 14. Section 63.20 is amended by * * * * * the International Bureau Filing System revising paragraph (a) to read as follows: I (IBFS), by letter, or by telegram making 18. Section 63.60 is amended by adding paragraph (d) to read as follows: § 63.20 Electronic filing; copies required; reference to this paragraph and setting fees, and filing periods for international forth the points between which § 63.60 Definitions. service providers. applicant desires to operate facilities of * * * * * (a) Electronic filing is voluntary at other carriers and the nature of the (d) You. In this section, ‘‘You’’ refers this time. However, applicants are traffic to be handled. For information on to applicants and licensees. encouraged to file applications filing your request through IBFS, see I 19. Section 63.701 is amended by electronically on the Internet through part 1, subpart Y and § 63.20 of this revising the introductory text to read as the International Bureau Filing System chapter, and the IBFS homepage at follows: (IBFS). If you file an application for http://www.fcc.gov/ibfs. international facilities and services * * * * * § 63.701 Contents of application. under Section 214 of the I 16. Section 63.51 is revised to read as Except as otherwise provided in this Communications Act of 1934, as follows: part, any party requesting designation as amended, through IBFS you are not a recognized private operating agency required to send the original or any § 63.51 Additional information. within the meaning of the International copies with your fee payment. For (a) You must provide additional Telecommunication Convention shall information on filing your application information if the Commission requests request such designation. Such through IBFS, see part 1, subpart Y of you to do so after it initially reviews designation may be requested this chapter, and the IBFS homepage at your application or request. electronically on the Internet through http://www.fcc.gov/ibfs. If you file a (b) If you do not respond to the the International Bureau Filing System paper application for international request or other official correspondence, (IBFS) or by paper. For information on facilities and services under Section 214 the Commission may dismiss your filing your notification through IBFS, of the Communications Act of 1934 as application without prejudice and you see part 1, subpart Y, and the IBFS amended, you must file an original and may file again with a completed homepage at http://www.fcc.gov/ibfs. If 5 copies. Upon request by the application. you file a paper application, file the Commission, additional copies of the (c) You can submit additional original and two copies, acknowledging application shall be furnished. Each information on paper or electronically that you must obey Article 6 of the ITU application shall be accompanied by the via e-mail. Constitution and that you will obey the

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mandatory provisions of the ITU DEPARTMENT OF TRANSPORTATION Corrections and Clarifications Convention and the international In the April 6, 2004, correction rule, Research and Special Programs telecommunications regulations RSPA/OPS amended the definition of Administration promulgated there under in all respects. ‘‘high consequence areas’’ by clarifying You must also include a statement that an operator using Method (1) to 49 CFR Part 192 illustrating that you know that identify these areas would have to violations may result in the Commission calculate and evaluate potential impact issuing a cease and desist order for [Docket No. RSPA–00–7666; Amendment circles on any transmission line in a future violations, and it may result in 192–95] Class 1 or Class 2 location. RSPA/OPS revocation of your private operating removed the phrase ‘‘outside a Class 3 agency status. This statement must RIN 2137–AD54 or Class 4 location’’ to clarify that an include the following information operator does not have to evaluate where it is applicable: Pipeline Safety: Pipeline Integrity segments that have already been Management in High Consequence * * * * * classified as ‘‘high consequence areas.’’ Areas (Gas Transmission Pipelines) However, RSPA/OPS erroneously used PART 64—MISCELLANEOUS RULES AGENCY: Office of Pipeline Safety (OPS), the term ‘‘potential impact radius’’ in RELATING TO COMMON CARRIERS Research and Special Programs paragraph (1)(iv) instead of the term Administration (RSPA), DOT. ‘‘potential impact circle.’’ In this correction rule, RSPA/OPS is replacing I 20. The Authority citation for part 64 ACTION: Final rule; correction. the word ‘‘radius’’ with ‘‘circle.’’ continues to read as follows: 47 U.S.C. SUMMARY: This document corrects a Section 192.925 sets forth the 154, 254(k); secs. 403(b)(2)(B), (c), Pub. L. requirements for external corrosion 104–104, 110 Stat. 56. Interpret or apply final rule published in the Federal Register on December 15, 2003, (68 FR direct assessment. This was change 47 U.S.C. 201, 218, 225, 226, 228, and number 9 in the April 6, 2004 correction 254(k) unless otherwise noted. 69778) and a correction document to that rule published in the Federal rule. In that document, RSPA/OPS I 21. Section 64.1001 is amended by Register on April 6, 2004 (69 FR 18228). revised the introductory text in revising paragraph (b) to read as follows: The final rule of December 15, 2003, paragraph (b) to clarify what an operator requires operators to develop integrity is required to do if the External § 64.1001 International settlements policy management programs for gas Corrosion Direct Assessment detects and modification requests. transmission pipelines located where a pipeline coating damage. RSPA/OPS has * * * * * leak or rupture could do the most harm, since become aware that the Federal Register read this instruction as revising (b) If your international settlement i.e., where a gas transmission pipeline paragraph (b) and as deleting the further arrangement in the operating agreement could impact a high consequence area requirements in subparagraphs (b)(1) or amendment referred to in (HCA). This document makes minor corrections to the rule. through (b)(4). RSPA/OPS did not § 43.51(e)(1) or (e)(2) of this chapter intend for the revision to delete these differs from the arrangement in effect in DATES: Effective Date: The effective date requirements. This correction rule adds the operating agreement of another is May 26, 2004. back to the final rule the missing carrier that provides service to or from FOR FURTHER INFORMATION CONTACT: requirements of paragraphs (b)(1) the same foreign point, you must file a Mike Israni by phone at (202) 366–4571, through (b)(4). This correction rule modification request under this section by fax at (202) 366–4566, or by e-mail presents § 192.925(b) in its entirety, unless the international route is exempt at [email protected], regarding with the revised language in the from the international settlements the subject matter of the final rule. introductory paragraph. policy under § 43.51 (e)(3) of this SUPPLEMENTARY INFORMATION: In the April 6, 2004, correction rule, chapter. If you must file a modification we revised paragraph (d) of § 192.935 to request, you can either file Background include requirements for additional electronically or on paper. The On December 15, 2003, RSPA/OPS preventive and mitigative measures for electronic form requires you to submit published a final rule (68 FR 69778) that a pipeline operating below 30% SMYS the same information that is required in requires operators of gas transmission located in a Class 3 or Class 4 area. In the paper filing, specified in paragraphs pipelines to develop and implement a the requirements, we referenced the (c) and (d) of this section. A comprehensive integrity management reassessment requirements of modification request may be filed program for pipeline segments located §§ 192.941(b) and 192.941(c). RSPA/ electronically on the Internet through in areas where a failure would have the OPS did not mean to add these the International Bureau Filing System greatest impact to the public or references as they only add confusion to (IBFS) or by paper. For information on property. On April 6, 2004, RSPA/OPS the final rule. In this correction rule, RSPA/OPS is removing the references to filing your modification through IBFS, published a correction rule that made editorial and typographical corrections the reassessment requirements of see part 1, subpart Y, and the IBFS to the final rule and addressed a petition §§ 192.941(b) and 192.941(c) to avoid homepage at http://www.fcc.gov/ibfs. for reconsideration filed by the further confusion. * * * * * Interstate Natural Gas Association of Section I of Appendix E provides [FR Doc. 04–11790 Filed 5–25–04; 8:45 am] America. additional guidance on determining a high consequence area. The second BILLING CODE 6712–01–P Purpose for This Document sentence in this section erroneously The April 6, 2004, correction rule states that an operator must use method contained errors. This correction (a) or (b) from the definition in document corrects those errors and § 192.903 to identify a ‘‘high corrects additional errors identified in consequence area.’’ The sentence is now the December 15, 2003, final rule. corrected to state that an operator must

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use method (1) or (2) from the definition (ii) The basis on which an operator severity classification, the priority of in § 192.903 to identify a ‘‘high selects at least two different, but direct examination, and the time frame consequence area.’’ complementary indirect assessment for direct examination of indications; tools to assess each ECDA Region. If an and List of Subjects in 49 CFR Part 192 operator utilizes an indirect inspection (iv) Criteria that describe how and on High consequence areas, method that is not discussed in what basis an operator will reclassify Incorporation by reference, Integrity Appendix A of NACE RP0502–2002, the and reprioritize any of the provisions management, Pipeline safety, Potential operator must demonstrate the that are specified in section 5.9 of NACE impact areas, Reporting and applicability, validation basis, RP0502–2002. recordkeeping requirements. equipment used, application procedure, (4) Post assessment and continuing and utilization of data for the inspection I Accordingly, 49 CFR Part 192 is evaluation. In addition to the method. corrected by making the following requirements in ASME/ANSI B31.8S (2) Indirect examination. In addition correcting amendments: section 6.4 and NACE RP 0502–2002, to the requirements in ASME/ANSI section 6, the plan’s procedures for post PART 192—[AMENDED] B31.8S section 6.4 and NACE RP 0502– assessment of the effectiveness of the 2002, section 4, the plan’s procedures ECDA process must include— I 1. The authority citation for part 192 for indirect examination of the ECDA (i) Measures for evaluating the long- continues to read as follows: regions must include— term effectiveness of ECDA in Authority: 49 U.S.C. 5103, 60102, 60104, (i) Provisions for applying more addressing external corrosion in covered 60108, 60109, 60110, 60113, and 60118; and restrictive criteria when conducting segments; and ECDA for the first time on a covered 49 CFR 1.53. (ii) Criteria for evaluating whether segment; conditions discovered by direct § 192.903 [Amended] (ii) Criteria for identifying and examination of indications in each documenting those indications that I 2. In § 192.903 the definition of ‘‘high ECDA region indicate a need for must be considered for excavation and consequence area’’ is amended by reassessment of the covered segment at direct examination. Minimum removing the word ‘‘radius’’ from an interval less than that specified in identification criteria include the paragraph (1)(iv) and adding the word § 192.939. (See Appendix D of NACE known sensitivities of assessment tools, ‘‘circle’’ in its place. RP0502–2002.) the procedures for using each tool, and I 3. Section 192.925 is amended by the approach to be used for decreasing * * * * * revising paragraph (b) to read as follows: the physical spacing of indirect I 4. Section 192.935 is amended by § 192.925 What are the requirements for assessment tool readings when the revising the introductory text of using External Corrosion Direct presence of a defect is suspected; paragraph (d) to read as follows: Assessment (ECDA)? (iii) Criteria for defining the urgency of excavation and direct examination of § 192.935 What additional preventive and * * * * * mitigative measures must an operator take? each indication identified during the (b) General requirements. An operator indirect examination. These criteria * * * * * that uses direct assessment to assess the must specify how an operator will (d) Pipelines operating below 30% threat of external corrosion must follow define the urgency of excavating the SMYS. An operator of a transmission the requirements in this section, in indication as immediate, scheduled or pipeline operating below 30% SMYS ASME/ANSI B31.8S (ibr, see § 192.7), monitored; and located in a high consequence area must section 6.4, and in NACE RP 0502–2002 (iv) Criteria for scheduling excavation follow the requirements in paragraphs (ibr, see § 192.7). An operator must of indications for each urgency level. (d)(1) and (d)(2) of this section. An develop and implement a direct (3) Direct examination. In addition to operator of a transmission pipeline assessment plan that has procedures the requirements in ASME/ANSI B31.8S operating below 30% SMYS located in addressing preassessment, indirect section 6.4 and NACE RP 0502–2002, a Class 3 or Class 4 area but not in a examination, direct examination, and section 5, the plan’s procedures for high consequence area must follow the post-assessment. If the ECDA detects direct examination of indications from requirements in paragraphs (d)(1), (d)(2) pipeline coating damage, the operator the indirect examination must include— and (d)(3) of this section. must also integrate the data from the (i) Provisions for applying more * * * * * ECDA with other information from the restrictive criteria when conducting data integration (§ 192.917(b)) to ECDA for the first time on a covered Appendix E to Part 192—[Amended] evaluate the covered segment for the segment; I threat of third party damage, and to 5. In Appendix E to Part 192, the (ii) Criteria for deciding what action introductory text of Section I is amended address the threat as required by should be taken if either: § 192.917(e)(1). by removing the words ‘‘method (a) or (A) Corrosion defects are discovered (b)’’ from the second sentence and (1) Preassessment. In addition to the that exceed allowable limits (Section adding the words ‘‘method (1) or (2)’’ in requirements in ASME/ANSI B31.8S 5.5.2.2 of NACE RP0502–2002), or its place. section 6.4 and NACE RP 0502–2002, (B) Root cause analysis reveals section 3, the plan’s procedures for conditions for which ECDA is not Issued in Washington, DC, on May 20, preassessment must include— suitable (Section 5.6.2 of NACE 2004. (i) Provisions for applying more RP0502–2002); Samuel G. Bonasso, restrictive criteria when conducting (iii) Criteria and notification Deputy Administrator. ECDA for the first time on a covered procedures for any changes in the ECDA [FR Doc. 04–11789 Filed 5–25–04; 8:45 am] segment; and Plan, including changes that affect the BILLING CODE 4910–60–P

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DEPARTMENT OF COMMERCE catcher/processor, mothership, and (a)(4)(iii)(D), NMFS revises paragraph B. shore-based sectors of the whiting of Section IV. of the 2004 harvest National Oceanic and Atmospheric fishery. For 2004, the 215,500 mt specification and management measures Administration commercial OY for whiting is divided (69 FR 11064, March 9, 2004, as with the catcher/processor sector amended at 69 FR 23667 (April 30, 50 CFR Part 660 receiving 73,270 mt (34 percent); the 2004), by adding a new paragraph. mothership sector receiving 51,720 mt [Docket No. 031216314–4118–03; I.D. IV. NMFS Actions (24 percent); and the shore-based sector 052004B] * * * * * receiving 90,510 mt (42 percent). The RIN 0648–AR54 regulations further divide the shore- B. * * * based allocation so that no more than 5 (3) * * * Fisheries off West Coast States and in percent (4,526 mt) of the shore-based (b) * * * the Western Pacific; Pacific Coast allocation may be taken in waters off the (iv) Closure of shore-based sector Groundfish Fishery; Temporary State of California before the primary south of 42° N. lat. Effective noon May Closure for the Shore-Based Whiting season begins north of 42° N. lat. Sector The primary season for the shore- 22, 2004, to 0001 hours June 15, 2004 based sector is the period(s) when the l.t. the primary whiting season south of AGENCY: National Marine Fisheries ° large-scale target fishery is conducted, 42 N. lat is closed. Landing and Service (NMFS), National Oceanic and and when ‘‘per trip’’ limits are not in frequency limits imposed under Atmospheric Administration (NOAA), effect. Because whiting migrate from paragraph (b) of this section are in effect Commerce. south to north during the fishing year, until the primary whiting season ACTION: Fishing restrictions; request for the shore-based primary season begins reopens on June 15, 2004. comments. earlier south of 42° N. lat. than north. * * * * * For 2004, the primary season for the SUMMARY: NMFS announces a temporary Classification shore-based sector between 42°-40°30’ closure of the primary season for Pacific N. lat. began on April 1; south of 40°30’ This action is authorized by the whiting (whiting) south of 42° N. lat. at N. lat. the primary season began on regulations implementing the FMP. The noon local time (l.t.) May 22, 2004. ‘‘Per April 15; and the fishery north of 42° N. determination to take these actions is trip’’ limits for whiting will be lat. is scheduled to begin June 15. based on the most recent data available. reinstated until 0001 hours June 15, Because the 4,526–mt allocation for The aggregate data upon which the 2004, at which time the primary season the early season fishery off California is determinations are based are available south of 42° N. lat. will re-open. This estimated to be reached, NMFS is for public inspection at the office of the action is authorized by regulations announcing the closure of the primary Regional Administrator (see ADDRESSES) implementing the Pacific Coast whiting season south of 42° N. lat. The during business hours. Groundfish Fishery Management Plan 20,000–lb (9,072–kg) trip limit that was (FMP), which governs the groundfish The Assistant Administrator for in place before the start of the southern Fisheries, NOAA, (AA) finds good cause fishery off Washington, Oregon, and primary season is being reinstated and California. This action is intended to to waive the requirement to provide will remain in effect until the primary prior notice and opportunity for keep the harvest of whiting at the 2004 season north of 42° N. lat. opens on June allocation levels. comment on this action pursuant to 5 15. A trip limit of 10,000 lb (4,536 kg) U.S.C. 553 (b)(B), because providing DATES: Effective from noon l.t. May 22, of whiting is in effect year-round (unless prior notice and opportunity would be 2004, until 0001 hours June 15, 2004. landings of whiting are prohibited) for impracticable and contrary to the public Comments will be accepted through vessels that fish in the Eureka area interest. It would be impracticable and June 10, 2004. shoreward of the 100–fm (183–m) contrary to the pubic interest because if ADDRESSES: You may submit comments, contour at any time during a fishing this closure were delayed in order to identified by (docket number and/or trip. This smaller limit is intended to provide prior notice and opportunity for RIN number), by any of the following minimize incidental catch of chinook public comment, the fishery would methods: salmon which are more likely to be exceed the early season sector allocation ∑ E-mail: caught shallower than 100 fm (183 m) for whiting south of 42° N. lat. [email protected]. in the Eureka area. Similarly, the AA finds good cause to The best available information on Include (docket number and/or RIN waive the 30–day delay in effectiveness May 20, 2004, indicates that 3,999 mt of number) in the subject line of the requirement of 5 U.S.C. 553 (d)(3) as whiting have been taken by the shore- message. such a delay would cause the fishery ∑ based fishery south of 42° N. lat. Federal eRulemaking Portal: http:// south of 42° S. lat. to exceed its through May, 16, 2004 and that the www.regulations.gov. Follow the allocation. Allowing the early season 4,526 mt allocation is projected to be instructions for submitting comments. fishery to continue would result in a ∑ taken by noon May 22, 2004. Therefore, Fax: 206–526–6736, Attn: Becky disproportionate shift in effort which the 20,000–lb (9,072–kg) per-trip limits Renko. could result in greater impacts on ∑ announced in the 2004 specifications Mail: D. Robert Lohn, Endangered Species Act listed chinook and management measures (69 FR Administrator, Northwest Region, salmon and overfished groundfish 11064, March 9, 2004 as amended at 69 NMFS, 7600 Sand Point Way NE, species that had been considered when FR 23667, April 30, 2004) will resume Seattle, WA 98115–0070, Attn: Becky the 2004 Pacific Coast groundfish until the primary season begins north of Renko. harvest specifications were established. 42° N. lat. FOR FURTHER INFORMATION CONTACT: This action is taken under the authority Becky Renko at 206–526–6110. NMFS Action of 50 CFR 660.323(a)(4)(i)(B) and SUPPLEMENTARY INFORMATION: The For the reasons stated above, and in (a)(4)(iii)(D), and is exempt from review regulations at 50 CFR 660.323(a) (3) and accordance with the regulations at 50 under Executive Order 12866. (4) establish separate allocations for the CFR 660.323 (a)(4)(i)(B) and Authority: 16 U.S.C. 1801 et seq.

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Dated: May 21, 2004. Bruce C. Morehead, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 04–11924 Filed 5–21–04; 2:35 pm] BILLING CODE 3510–22–S

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Proposed Rules Federal Register Vol. 69, No. 102

Wednesday, May 26, 2004

This section of the FEDERAL REGISTER www.ams.usda.gov/2002farmbill/ Research Act of 1985; Commodity contains notices to the public of the proposed organicexempt. Promotion, Research, and Information issuance of rules and regulations. The Pursuant to the Paperwork Reduction Act of 1996; Cotton Research and purpose of these notices is to give interested Act (PRA), send comments regarding the Promotion Act; Dairy Production persons an opportunity to participate in the accuracy of the burden estimate, ways to Stabilization Act of 1983; Egg Research rule making prior to the adoption of the final minimize the burden, including the use rules. and Consumer Information Act; Fluid of automated collection techniques or Milk Promotion Act of 1990; Hass other forms of information technology, Avocado Promotion, Research, and DEPARTMENT OF AGRICULTURE or any other aspect of this collection of Information Act of 2000; Honey information to the above address. Research, Promotion, and Consumer Agricultural Marketing Service Comments concerning the information Information Act; Mushroom Promotion, collection under the PRA should also be Research, and Consumer Information 7 CFR Parts 1150, 1160, 1205, 1207, sent to the Desk Officer for Agriculture, Act of 1990; Popcorn Promotion, 1209, 1210, 1215, 1216, 1218, 1219, Office of Information and Regulatory Research, and Consumer Information 1220, 1230, 1240, 1250, 1260, and 1280 Affairs, Office of Management and Act; Pork Promotion, Research, and Budget, Washington, DC 20503. Consumer Information Act of 1985; [Docket No. PY–02–006 Ext.] FOR FURTHER INFORMATION CONTACT: Potato Research and Promotion Act; RIN 0581–AC15 Angela C. Snyder, Office of the Deputy Soybean Promotion, Research, and Administrator, Poultry Programs, Consumer Information Act; and Proposed Rule To Exempt Organic Agricultural Marketing Service, U.S. Watermelon Research and Promotion Producers From Assessment by Department of Agriculture, 1400 Act. Independence Avenue, SW., STOP Research and Promotion Programs Dated: May 20, 2004. 0256, Room 3932-South, Washington, AGENCY: Agricultural Marketing Service, DC 20250; (202) 720–4476; (202) 720– Kenneth C. Clayton, USDA. 5631 (fax); or e-mail at Acting Administrator, Agricultural Marketing Service. ACTION: Proposed rule; extension of [email protected]. [FR Doc. 04–11878 Filed 5–25–04; 8:45 am] comment period. SUPPLEMENTARY INFORMATION: This BILLING CODE 3410–02–P proposed rule on the exemption of SUMMARY: Notice is hereby given that the comment period on the proposal to organic producers and marketers from exempt producers and marketers of assessment under research and promotion programs was published in NATIONAL CREDIT UNION solely 100 percent organic products ADMINISTRATION from paying assessments to any research the Federal Register on April 26, 2004 (69 FR 22690). The proposed rule and promotion program administered by 12 CFR Parts 721 and 724 the Agricultural Marketing Service invited comments through May 26, (AMS) is extended. 2004. Also, pursuant to the Paperwork Health Savings Accounts Reduction Act, comments on the DATES: Comments must be received by information collection burden were to AGENCY: National Credit Union June 25, 2004. be received by June 25, 2004. Administration (NCUA). ADDRESSES: Interested persons are An attorney representing several ACTION: Notice of proposed rulemaking. invited to submit written comments organic dairy companies requested that concerning this proposed rule to Angela the comment period be extended by SUMMARY: The NCUA is proposing to C. Snyder, Office of the Deputy thirty days to provide ample time for a amend its regulations governing a Administrator, Poultry Programs, thorough review and to ensure that federal credit union’s (FCU) authority to Agricultural Marketing Service, U.S. those most likely to be affected by the act as trustee or custodian to authorize Department of Agriculture, 1400 proposed rule have the opportunity to FCUs to serve as trustee or custodian for Independence Avenue, SW., STOP review and understand it before Health Savings Accounts (HSA). The 0256, Room 3932-South, Washington, submitting comments. This request was NCUA is issuing this proposed rule so DC 20250. Comments should be submitted in consideration of the that FCUs and their members can take submitted in duplicate. Comments may organic industry’s most significant advantage of the authority granted in the also be submitted electronically to: annual tradeshow and the most recent Medicare Prescription Drug, [email protected] or http:// National Organic Standards Board Improvement and Modernization Act of www.regulations.gov. All comments meeting, both of which coincided with 2003 (Medicare Act). The Medicare Act should reference the docket number and the pending comment period. authorizes the establishment of HSAs by the date and page number of this issue An extension would provide individuals who obtain a qualifying of the Federal Register. All comments interested persons more time to review high deductible health plan and received will be made available for and assess the proposed rule’s impacts. specifies that an HSA may be public inspection at Poultry Programs, Therefore, USDA is extending the established and maintained at an FCU. AMS, USDA, Room 3932-South, 1400 period in which to file written The proposed rule would also make a Independence Avenue, SW., comments until June 25, 2004. This conforming amendment to NCUA’s Washington, DC 20250 during regular notice is issued pursuant to the Farm incidental powers regulation to include business hours. A copy of the proposed Security and Rural Investment Act (Pub. trustee or custodial services for HSAs as rule may be found at: http:// L. 107–171); the Beef Promotion and a pre-approved activity.

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DATES: Comments must be received on maintain an HSA. A health plan with a references that authorize retirement, or before June 25, 2004. minimum deductible of at least $1,000 pension and education savings ADDRESSES: You may submit comments (for individual coverage) or $2,000 (for accounts. The proposed rule would also by any of the following methods (please family coverage) may qualify under the make changes to the section heading send comments by one method only): HSA rules even where certain and the caption of this part to reflect • Federal eRulemaking Portal: http:// preventive care services, as well as that trustee and custodial authority for www.regulations.gov. Follow the coverage for accidents, disability, dental FCUs is no longer limited to pension instructions for submitting comments. care, vision care, and long-term care, are and retirement plans. In this respect, the • NCUA Web Site: http:// not subject to the deductible. NCUA proposes to use the term ‘‘tax- www.ncua.gov/ Contributions to an HSA qualify for advantaged savings plans’’ as a more RegulationsOpinionsLaws/ an ‘‘above the line’’ tax deduction, descriptive and inclusive way to refer to proposed_regs/proposed_regs.html. whether or not the taxpayer itemizes the types of accounts and savings plans Follow the instructions for submitting other expenses on Schedule A. Income that members may establish and for comments. earned on funds in the account accrues which FCUs may fulfill trustee or • E-mail: Address to tax-free, and withdrawals for qualified custodial responsibilities. [email protected]. Include ‘‘[Your medical expenses are not taxable. As with an IRA, an individual who name] Comments on Proposed Rule 721 Contributions to an HSA may be made maintains an HSA has an option to and 724, Health Savings Accounts’’ in by the individual or his or her direct the investment choices. At the e-mail subject line. employer, and employer contributions present, however, both the text and the • Fax: (703) 518–6319. Use the are not taxable as income to the heading for § 724.2 refer only to subject line described above for e-mail. individual. Contributions to the account retirement plans in describing the role • Mail: Address to Becky Baker, for 2004 may not exceed the lesser of that an FCU may fulfill in assisting a Secretary of the Board, National Credit the annual deductible under the health member who elects to make investment Union Administration, 1775 Duke plan or $2,600 (for individuals) or choices outside the credit union. Street, Alexandria, Virginia 22314– $5,150 (for family coverage). Therefore, NCUA proposes to delete the 3428. Contribution limits are indexed reference to retirement from both the • Hand Delivery/Courier: Same as annually, and special ‘‘catch up’’ rules section heading and the first sentence of mail address. apply for individuals between ages 55 § 724.2, to clarify that members may and 65. Funds in the account may be determine investment options for HSAs FOR FURTHER INFORMATION CONTACT: Ross withdrawn tax-free if used to pay for as well. The amendment would not alter P. Kendall, Staff Attorney, at the above qualified medical expenses. Unlike any of the procedural limitations and address, or telephone: (703) 518–6562. Flexible Spending Accounts, any safeguards presently in the rule SUPPLEMENTARY INFORMATION: unused balance in an HSA may be concerning either the extent of the Background rolled over and accumulated from year actions an FCU may take or the notice to year, and the account is portable. requirements relating to the absence of The precursor to the HSA was the After retirement but before eligibility for share insurance for investment choices Medical Savings Account, a tax- Medicare, an account owner may use outside of share or share certificate advantaged savings plan that was funds in the account to purchase health accounts the FCU maintains. available only to certain individuals insurance, including long-term care The proposed rule would also amend who were either self-employed or insurance. After an individual reaches NCUA’s incidental powers regulation by employees of small companies. The law age 65 and is qualified for Medicare adding language to § 721.3, describing authorizing the creation of these coverage, any funds remaining in the those activities that are pre-approved for accounts contained other limitations as account may be used for any purpose, FCUs. Subsection (l) discusses the role well, including a ceiling on the number although such withdrawals are taxed as an FCU may fulfill as trustee or of persons nationwide who could ordinary income. Non-qualified custodian. The proposed rule would establish such an account, as well as an withdrawals before age 65 are taxable as simply add HSAs to the types of plans expiration provision. 26 U.S.C. 220. The income, and are also assessed a 10% for which an FCU may fulfill trustee or limitations raised doubt about whether penalty. Upon death, HSA ownership custodian responsibilities. A these accounts would become a may transfer to the spouse of the conforming amendment is proposed for permanent, viable alternative for account owner on a tax-free basis. the first sentence in this subsection, Americans seeking relief from the high Additional information about HSAs, substituting ‘‘tax-advantaged savings cost of health insurance. For these including important details concerning plans’’ for the current reference to reasons, the NCUA elected not to the type of high deductible health plan pension and profit-sharing plans, to include Medical Savings Accounts in its an individual must obtain to qualify for describe more clearly the types of 1998 amendment expanding the scope an HSA, is available from the Public accounts for which an FCU may serve of part 724 to include Roth IRAs, Affairs Office of the U.S. Department of as trustee or custodian. Coverdell Education Savings Accounts the Treasury. The information is The proposed rule would authorize and Savings Incentive Match Plans for directly accessible from the Treasury FCUs to serve as trustee or custodian for Employees. 63 FR 14025 (March 24, Web site, http://www.ustreas.gov. member HSAs. Whether similar 1998). authority exists for State chartered, FCUs as Trustees or Custodians for Title XII of the Medicare Act makes federally insured credit unions is a HSAs permanent and broadens the authority matter of applicable State law. for individuals to establish tax- Title XII of the Medicare Act will be advantaged savings accounts at financial codified as new section 223 of the Obligations of Trustee or Custodian institutions to support their payment of Internal Revenue Code (IRC). The NCUA understands that the Internal medical expenses not covered by health proposed rule would amend § 724.1 of Revenue Service (IRS) will prepare and insurance. Under the new law, anyone NCUA’s regulations by inserting a distribute comprehensive guidelines for who has a qualifying high deductible reference to section 223 of the IRC into HSA trustees or custodians, including health plan is eligible to establish and its text, to go along with the other IRC model forms, in the near future. The

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Department of the Treasury has already may reconsider its position at a later The Treasury and General Government issued some guidance, including that an time if circumstances warrant. Appropriations Act, 1999—Assessment HSA trustee will not be responsible for of Federal Regulations and Policies on monitoring or determining if a Request for Comments Families withdrawal from an HSA is for a The Board’s standard policy is to qualified medical purpose. See U.S. The NCUA has determined that this issue proposed regulations with a 60- final rule would not affect family well- Treasury Notice 2004–2—Guidance on day comment period. See NCUA Health Savings Accounts. NCUA being within the meaning of section 654 Interpretative Ruling and Policy anticipates that HSA trustees and of the Treasury and General Statement 87–2 (52 FR 35231, Sept. 18, custodians will be required to provide Government Appropriations Act, 1999, initial disclosures and monitor deposits 1987; as amended by IRPS 03–2, 68 FR Pub. L. 105–277, 112 Stat. 2681 (1998). made to the account to assure they do 31949, May 29, 2003). In this case, not exceed permissible annual however, the Board finds that a shorter List of Subjects comment period is warranted. The contribution limitations, and we expect 12 CFR Part 721 the guidelines will also require certain Medicare Act is already effective, and reporting to the IRS and to the account the Board anticipates the IRS will Incidental Powers. owner. produce and distribute model forms and NCUA anticipates and expects that related guidance for institutions acting 12 CFR Part 724 FCUs will comply with all applicable as trustee or custodian on or before the Pensions, Reporting and guidelines once established by the IRS. end of June 2004. A shorter comment recordkeeping, Trusts and trustees. NCUA does not anticipate that the period will minimize delays for FCUs obligations will be burdensome. NCUA seeking to offer this service to their By the National Credit Union notes that FCUs have been providing members. Administration Board, this 20th day of May, IRA trustee and custodial services for 2004. over 25 years. In its examination and Regulatory Procedures Becky Baker, supervision of FCUs during this time, Regulatory Flexibility Act Secretary, NCUA Board. NCUA has seen no indication of For the reasons stated in the regulatory problems or safety and This proposed rule conforms current preamble, NCUA proposes to amend 12 soundness concerns arising from this regulations to recent changes in the CFR chapter VII as follows: activity. This historical performance federal tax law and implements suggests that FCUs can safely provide authority for FCUs to offer HSAs to their PART 721—INCIDENTAL POWERS the same services for HSAs. members. The Board has determined Separate Share Insurance Coverage for and certifies that the proposed rule 1. The authority citation for part 721 HSAs would not have a significant economic continues to read as follows: impact on a substantial number of small The Board notes that, although it is Authority: 12 U.S.C. 1757(17), 1766 and credit unions. Accordingly, the NCUA set up as a trust account, an HSA is an 1789. account a member maintains for his or Board has determined that a Regulatory her own benefit. In view of the statutory Flexibility Analysis is not required. 2. Amend § 721.3 by revising limits on maximum annual Paperwork Reduction Act paragraph (l) to read as follows: contributions, as well as the likelihood § 721.3 What categories of activities are of frequent withdrawals from the HSA NCUA has determined that the preapproved as incidental powers to pay for medical expenses, the Board proposed rule would not increase necessary or requisite to carry on a credit does not anticipate that substantial paperwork requirements under the union’s business? balances in HSAs will accumulate in the Paperwork Reduction Act of 1995 and * * * * * short term. Also, the Federal Deposit regulations of the Office of Management Insurance Corporation, with which the and Budget. (l) Trustee or custodial services. NCUA has traditionally maintained Trustee or custodial services are parity on matters involving the scope of Executive Order 13132 services in which you are authorized to account insurance coverage, has act under any written trust instrument Executive Order 13132 encourages indicated it does not consider HSAs to or custodial agreement created or independent regulatory agencies to be a separate category for insurance organized in the United States and coverage purposes. As with other types consider the impact of their actions on forming part of a tax-advantaged savings of revocable trust accounts, the interests State and local interests. In adherence to plan, as authorized under the Internal of person(s) designated by the owner of fundamental federalism principles, Revenue Code. These services may an HSA to receive any balance in the NCUA, an independent regulatory include acting as a trustee or custodian account remaining after the owner’s agency as defined in 44 U.S.C. 3502(5), for member retirement, education and death may qualify for separate insurance voluntarily complies with the executive health savings accounts. coverage under existing rules. To order. The proposed rule would not qualify for separate insurance, the have substantial direct effects on the PART 724—TRUSTEES AND designated beneficiary must be the states, on the connection between the CUSTODIANS OF PENSION PLANS spouse, child, grandchild, parent or national government and the States, or sibling of the account owner and the on the distribution of power and 3. The authority citation for part 724 other requirements in our rule must be responsibilities among the various continues to read as follows: satisfied. 12 CFR 745.4. For these levels of government. NCUA has Authority: 12 U.S.C. 1757, 1765, 1766 and reasons, the Board is not proposing an determined that this rule does not 1787. amendment to NCUA’s share insurance constitute a policy that has federalism rules at present. The Board intends to implications for purposes of the 4. Revise the part heading for part 724 monitor developments in this area and executive order. to read as follows:

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PART 724—TRUSTEES AND availability of the ARAC-recommended Issued in Renton, Washington, on May 18, CUSTODIANS OF CERTAIN TAX- proposed flight crew alerting, and the 2004. ADVANTAGED SAVINGS PLANS proposed Advisory Circular (AC) Kevin Mullin, 25.1322, ‘‘Flight Crew Alerting,’’ for Acting Manager, Transport Airplane 5. Amend § 724.1 by revising the potential use, upon request, in the Directorate, Aircraft Certification Service. section heading and first two sentences [FR Doc. 04–11896 Filed 5–25–04; 8:45 am] to read as follows: certification of applicable airplane systems. The FAA has not yet adopted BILLING CODE 4910–13–M § 724.1 Federal credit unions acting as these ARAC recommendations. trustees and custodians of certain tax- advantaged savings plans. FOR FURTHER INFORMATION CONTACT: Mr. DEPARTMENT OF TRANSPORTATION A federal credit union is authorized to Loran Haworth, Federal Aviation act as trustee or custodian, and may Administration, Transport Airplane Federal Aviation Administration receive reasonable compensation for so Directorate, Transport Standards Staff, acting, under any written trust Airplane and Flight Crew Interface 14 CFR Part 39 instrument or custodial agreement Branch, ANM–111, 1601 Lind Avenue [Docket No. 2004–CE–11–AD] created or organized in the United SW., Renton, WA 98055–4056; RIN 2120–AA64 States and forming part of a tax- telephone (425) 227–1133; fax (425) advantaged savings plan which qualifies 227–1320; e-mail: Airworthiness Directives; Raytheon or qualified for specific tax treatment [email protected]. Aircraft Company Model B100 under sections 223, 401(d), 408, 408A Airplanes and 530 of the Internal Revenue Code SUPPLEMENTARY INFORMATION: Reference: (26 U.S.C. 223, 401(d), 408, 408A and FAA policy memorandum 00–113–1034 AGENCY: Federal Aviation 530), for its members or groups of its ‘‘Use of ARAC (Aviation Rulemaking Administration (FAA), DOT. members, provided the funds of such Advisory Committee) Recommended ACTION: Notice of proposed rulemaking plans are invested in share accounts or Rulemaking not yet formally adopted by (NPRM). share certificate accounts of the Federal the FAA, as a basis for equivalent level credit union. Federal credit unions of safety or exemption to Part 25.’’ SUMMARY: The FAA proposes to adopt a located in a territory, including the trust new airworthiness directive (AD) for This policy memorandum describes a certain Raytheon Aircraft Company territories, or a possession of the United standardized, streamlined approach for States, or the Commonwealth of Puerto (Raytheon) Model B100 airplanes. This the use of draft FAA/Joint Aviation proposed AD would require you to drill Rico, are also authorized to act as Authorities (JAA) harmonized trustee or custodian for such plans, if holes in the hot lip tube ‘‘B’’ nuts; regulations as a basis for an equivalent authorized under sections 223, 401(d), tighten the ‘‘B’’ nuts to specified torque level of safety finding or an exemption 408, 408A and 530 of the Internal ranges; and secure the ‘‘B’’ nuts with Revenue Code as applied to the territory to part 25. It may be found on the safety wire. This proposed AD is the or possession under similar provisions Internet at the following Web site result of reports of loose ‘‘B’’ nuts on the of territorial law. * * * address: http://www.airweb.faa.rgl. engine inlet that may loosen and permit a leak in the engine inlet anti-ice 6. Amend § 724.2 by revising the Background section heading and introductory text to system. We are issuing this proposed read as follows: After a multi-year review of the AD to detect and correct loose ‘‘B’’ nuts current § 25.1322 and creation of the on the engine inlet, which could result § 724.2 Self-Directed Plans. proposed AC 25.1322, the ARAC in failure of the engine inlet anti-ice A federal credit union may facilitate submitted to the FAA their system and consequent ice buildup. transfers of plan funds to assets other This failure and ice buildup could lead recommendations for a rule change and than share and share certificates of the to an engine’s ingestion of ice with loss the proposed advisory circular in May credit union, provided the conditions of of engine power or loss of engine. 2004. The ARAC-recommended § 724.1 are met and the following DATES: proposed changes to 14 CFR 25.1322 We must receive any comments additional conditions are met: * * * on this proposed AD by July 26, 2004. and the newly proposed AC 25.1322 are [FR Doc. 04–11903 Filed 5–25–04; 8:45 am] available on the Internet at the following ADDRESSES: Use one of the following to BILLING CODE 7535–01–P Web site address: http://www.faa.gov/ submit comments on this proposed AD: • avr/arm/arac/aractasks/ By mail: FAA, Central Region, aracavsysrecommendation4. Office of the Regional Counsel, DEPARTMENT OF TRANSPORTATION cfm?nav=6&task=2. If you do not have Attention: Rules Docket No. 2004–CE– access to the Internet, you can obtain a 11–AD, 901 Locust, Room 506, Kansas Federal Aviation Administration City, Missouri 64106. copy of the policy by contacting the • By fax: (816) 329–3771. 14 CFR Part 25 person listed under FOR FURTHER • By e-mail: 9–ACE–7– INFORMATION CONTACT. [email protected]. Comments sent Proposed Changes and Advisory The procedure for using ARAC electronically must contain ‘‘Docket No. Circular 25.1322 recommendations for rule changes that 2004–CE–11–AD’’ in the subject line. If AGENCY: Federal Aviation are not yet adopted by the FAA is you send comments electronically as Administration (FAA), DOT. described in the FAA policy attached electronic files, the files must be formatted in Microsoft Word 97 for ACTION: Notice of availability of memorandum 00–113–1034 referenced Windows or ASCII. Aviation Rulemaking Advisory above. The memorandum describes the Committee (ARAC) recommendations. process for requesting an equivalent You may get the service information safety finding, as well as petitioning for identified in this proposed AD from SUMMARY: The Federal Aviation an exemption. Raytheon Aircraft Company, 9709 E. Administration (FAA) announces the Central, Wichita, Kansas 67201–0085;

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telephone: (800) 429–5372 or (316) 676– part of this proposed AD, we will —securing the ‘‘B’’ nuts (P/N AN818–6D 3140. summarize the contact and place the and P/N AN818–8D) with safety wire. You may view the AD docket at FAA, summary in the docket. We will FAA’s Determination and Requirements Central Region, Office of the Regional consider all comments received by the of This Proposed AD Counsel, Attention: Rules Docket No. closing date and may amend this 2004–CE–11–AD, 901 Locust, Room proposed AD in light of those comments What has FAA decided? We have 506, Kansas City, Missouri 64106. Office and contacts. evaluated all pertinent information and hours are 8 a.m. to 4 p.m., Monday Discussion identified an unsafe condition that is through Friday, except Federal holidays. likely to exist or develop on other What events have caused this FOR FURTHER INFORMATION CONTACT: Jeff products of this same type design. proposed AD? The FAA has received six Pretz, Aerospace Engineer, Wichita Therefore, we are proposing AD action. reports of loose ‘‘B’’ nuts on the Aircraft Certification Office, FAA, 1801 What would this proposed AD Raytheon Model B100 engine inlet anti- require? This proposed AD would Airport Road, Mid-Continent Airport, ice system found during routine require you to incorporate the actions in Wichita, Kansas 67209; telephone: (316) maintenance. These loose ‘‘B’’ nuts may the previously-referenced service 946–4153; facsimile: (316) 946–4407. permit a leak in the engine inlet anti-ice bulletin. SUPPLEMENTARY INFORMATION: system that would result in failure of How does the revision to 14 CFR part Comments Invited the system with consequent ice buildup on the engine inlet. 39 affect this proposed AD? On July 10, How do I comment on this proposed What is the potential impact if FAA 2002, we published a new version of 14 AD? We invite you to submit any took no action? Failure of the engine CFR part 39 (67 FR 47997, July 22, written relevant data, views, or inlet anti-ice system and consequent ice 2002), which governs FAA’s AD system. arguments regarding this proposal. Send buildup could lead to an engine’s This regulation now includes material your comments to an address listed ingestion of ice with loss of engine that relates to altered products, special under ADDRESSES. Include ‘‘AD Docket power or loss of engine. flight permits, and alternative methods No. 2004–CE–11–AD’’ in the subject Is there service information that of compliance. This material previously line of your comments. If you want us applies to this subject? Raytheon has was included in each individual AD. to acknowledge receipt of your mailed issued Service Bulletin No. SB 30–3143, Since this material is included in 14 comments, send us a self-addressed, dated September 2001. CFR part 39, we will not include it in stamped postcard with the docket What are the provisions of this service future AD actions. number written on it. We will date- information? The service bulletin Costs of Compliance stamp your postcard and mail it back to includes procedures for: you. —Drilling a 0.035-inch hole in each of How many airplanes would this Are there any specific portions of this the hot lip tube ‘‘B’’ nuts (part proposed AD impact? We estimate that proposed AD I should pay attention to? numbers (P/N) AN818–6D and this proposed AD affects 96 airplanes in We specifically invite comments on the AN818–8D); the U.S. registry. overall regulatory, economic, —tightening P/N AN818–6D ‘‘B’’ nuts to What would be the cost impact of this environmental, and energy aspects of a torque range of 75 to 125 inch- proposed AD on owners/operators of the this proposed AD. If you contact us pounds and P/N AN818–8D ‘‘B’’ nuts affected airplanes? We estimate the through a nonwritten communication to a torque range of 150 to 250 inch- following costs to accomplish this and that contact relates to a substantive pounds; and proposed inspection and modification:

Total cost Labor cost Parts cost Total cost on U.S. per airplane operations

4 workhours × $65 per hour = $260...... Not applicable...... $260 $24,960

Regulatory Findings 2. Is not a ‘‘significant rule’’ under the The Proposed Amendment DOT Regulatory Policies and Procedures Would this proposed AD impact (44 FR 11034, February 26, 1979); and Accordingly, under the authority various entities? We have determined delegated to me by the Administrator, that this proposed AD would not have 3. Will not have a significant the Federal Aviation Administration federalism implications under Executive economic impact, positive or negative, proposes to amend 14 CFR part 39 as Order 13132. This proposed AD would on a substantial number of small entities follows: not have a substantial direct effect on under the criteria of the Regulatory Flexibility Act. the States, on the relationship between PART 39—AIRWORTHINESS the national Government and the States, We prepared a summary of the costs DIRECTIVES or on the distribution of power and to comply with this proposed AD and responsibilities among the various placed it in the AD Docket. You may get 1. The authority citation for part 39 levels of government. a copy of this summary by sending a continues to read as follows: request to us at the address listed under Would this proposed AD involve a Authority: 49 U.S.C. 106(g), 40113, 44701. ADDRESSES. Include ‘‘AD Docket No. significant rule or regulatory action? For 2004–CE–11–AD’’ in your request. § 39.13 [Amended] the reasons discussed above, I certify that this proposed AD: List of Subjects in 14 CFR Part 39 2. The FAA amends § 39.13 by adding the following new airworthiness 1. Is not a ‘‘significant regulatory Air transportation, Aircraft, Aviation directive (AD): action’’ under Executive Order 12866; safety, Safety.

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Raytheon Aircraft Company: Docket No. What Airplanes Are Affected by This AD? intended to detect and correct loose ‘‘B’’ nuts 2004–CE–11–AD (c) This AD affects Models B100, serial on the engine inlet, which could result in When Is the Last Date I Can Submit numbers BE–1 through BE–136, that are failure of the engine inlet anti-ice system and Comments on This Proposed AD? certificated in any category. consequent ice buildup. This failure and ice buildup could lead to an engine’s ingestion (a) We must receive comments on this What Is the Unsafe Condition Presented in of ice with loss of engine power or loss of proposed airworthiness directive (AD) by This AD? July 26, 2004. engine. (d) This AD is the result of reports of loose What Other ADs Are Affected by This ‘‘B’’ nuts on the engine inlet that may loosen What Must I Do To Address This Problem? Action? and permit a leak in the engine inlet anti-ice (e) To address this problem, you must do (b) None. system. The actions specified in this AD are the following, unless already done:

Actions Compliance Procedures

(1) Drill a 0.035-inch hole in each of the hot lip Within the next 150 hours time-in-service Follow Raytheon Aircraft Mandatory Service tube ‘‘B’’ nuts (part number (P/N) AN818–6D (TIS) or 6 calendar months after the effec- Bulletin No. SB 30–3143, dated September and AN818–8D). tive date of this AD, whichever occurs first. 2001. The applicable airplane maintenance manual also addresses this issue. (2) Tighten the hot lip tube ‘‘B’’ nuts to a speci- Before further flight after the actions required Follow Raytheon Aircraft Mandatory Service fied torque range:. by paragraph (e)(1) of this AD. Bulletin No. SB 30–3143, dated September (i) Tighten hot lip tube ‘‘B’’ nuts P/N AN818–6D 2001. The applicable airplane maintenance to a torque range of 75 to 125 inch-pounds. manual also addresses this issue. (ii) Tighten hot lip tube ‘‘B’’ nuts P/N AN818– 8D to a torque range of 150 to 250 inch- pounds. (3) Secure the hot lip tube ‘‘B’’ nuts (P/N Before further flight after the actions required Follow Raytheon Aircraft Mandatory Service AN818–6D and AN818–8D) with safety wire. by paragraph (e)(2) of this AD. Bulletin No. SB 30–3143, dated September 2001. The applicable airplane maintenance manual also addresses this issue.

May I Request an Alternative Method of DEPARTMENT OF HEALTH AND Planning (HF–27), Food and Drug Compliance? HUMAN SERVICES Administration, 5600 Fishers Lane, (f) You may request a different method of Rockville, MD 20857, 301–827–7010. compliance or a different compliance time Food and Drug Administration for this AD by following the procedures in 14 SUPPLEMENTARY INFORMATION: In FR Doc. CFR 39.19. Unless FAA authorizes otherwise, 21 CFR Part 59 04–9699, appearing on page 23460 in send your request to your principal the Federal Register of Thursday, April inspector. The principal inspector may add [Docket No. 2004N–0184] 29, 2004, the following corrections are comments and will send your request to the made: Manager, Wichita Aircraft Certification Office RIN 0910–AB96 1. On page 23460, in the second (ACO), FAA. For information on any already approved alternative methods of compliance, Requirements Pertaining to Sampling column, in the heading of the contact Jeff Pretz, Aerospace Engineer, Services and Private Laboratories document, ‘‘[Docket No. 2002N–0085]’’ Wichita ACO, FAA, 1801 Airport Road, Mid- Used in Connection With Imported is corrected to read ‘‘[Docket No. Continent Airport, Wichita, Kansas 67209; Food; Correction 2004N–0184]’’. telephone: (316) 946–4153; facsimile: (316) 2. On page 23460, in the second 946–4407. AGENCY: Food and Drug Administration, column, in the ADDRESSES section, in HHS. May I Get Copies of the Documents the line beginning with ‘‘identified by Referenced in This AD? ACTION: Proposed rule; correction. Docket No. 2002N–0085,’’, ‘‘[Docket No. (g) You may get copies of the documents 2002N–0085]’’ is corrected to read SUMMARY: The Food and Drug referenced in this AD from Raytheon Aircraft ‘‘[Docket No. 2004N–0184]’’. Administration (FDA) is correcting a Company, 9709 E. Central, Wichita, Kansas 3. On page 23460, in the third 67201–0085; telephone: (800) 429–5372 or proposed rule that appeared in the column, in the ADDRESSES section, in (316) 676–3140. You may view these Federal Register of April 29, 2004 (69 documents at FAA, Central Region, Office of FR 23460). The document proposed new the seventh line beginning with the Regional Counsel, 901 Locust, Room 506, regulations for persons who use ‘‘Include Docket No. 2002N–0085’’, Kansas City, Missouri 64106. sampling services (services that collect ‘‘[Docket No. 2002N–0085]’’ is corrected to read ‘‘[Docket No. 2004N–0184]’’ Issued in Kansas City, Missouri, on May samples for another party) and private 20, 2004. laboratories used in connection with Dated: May 19, 2004. James E. Jackson, imported food. The document was Jeffrey Shuren, published with inadvertent errors. This Acting Manager, Small Airplane Directorate, Assistant Commissioner for Policy. document corrects those errors. Aircraft Certification Service. [FR Doc. 04–11827 Filed 5–25–04; 8:45 am] [FR Doc. 04–11877 Filed 5–25–04; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4160–01–S BILLING CODE 4910–13–P Joyce Strong, Office of Policy and

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ENVIRONMENTAL PROTECTION (MDAQMD), Santa Barbara County Air Feather River Air Quality Management AGENCY Pollution Control District (SBCAPCD), District, 938–14th Street, Marysville, and Yolo-Solano Air Pollution Control CA 95901–4149. 40 CFR Part 52 District (YSAPCD) portions of the Kern County Air Pollution Control California State Implementation Plan District, 2700 ‘‘M’’ Street, Suite 302, [CA 040–0448b; FRL–7662–1] (SIP). Under authority of the Clean Air Bakersfield, CA 93301–2370. Act as amended in 1990 (CAA or the Revisions to the California State Mojave Desert Air Quality Management Act), we are proposing to approve local Implementation Plan, El Dorado District, 14306 Park Avenue, rules that address emission statements. County Air Pollution Control District, Victorville, CA 92392–2310. DATES: Feather River Air Quality Management Any comments on this proposal Sacramento Metropolitan Air Quality District, Kern County Air Pollution must arrive by June 25, 2004. Management District, 777–12th Street, Control District, Sacramento ADDRESSES: Send comments to Andy Third Floor, Sacramento, CA 95814– Metropolitan Air Quality Management Steckel, Rulemaking Office Chief (AIR– 1908. District, San Bernardino County Air 4), U.S. Environmental Protection Santa Barbara County Air Pollution Pollution Control District, Santa Agency, Region IX, 75 Hawthorne Control District, 26 Castilian Drive, Barbara County Air Pollution Control Street, San Francisco, CA 94105–3901, Suite B–23, Goleta, CA 93117–3027. District, and Yolo-Solano Air Pollution or e-mail to [email protected], or Yolo-Solano Air Quality Management Control District submit comments at http:// District, 1947 Galileo Court, Suite www.regulations.gov. 103, Davis, CA 95616–4882. AGENCY: You can inspect copies of the Environmental Protection Copies of these rules may also be submitted SIP revisions, EPA’s technical Agency (EPA). available via the Internet at the support documents (TSDs), and public ACTION: Proposed rule. following sites respectively, http:// comments at our Region IX office during www.arb.ca.gov/drdb/drdbltxt.htm. SUMMARY: EPA is proposing to approve normal business hours by appointment. Please be advised that this is not an EPA revisions to the El Dorado County Air You may also see copies of the Web site and may not contain the same Pollution Control District (EDCAPCD), submitted SIP revisions by appointment version of the rules that were submitted Feather River Air Quality Management at the following locations: to EPA. District (FRAQMD), Kern County Air California Air Resources Board, Pollution Control District (KCAPCD), Stationary Source Division, Rule FOR FURTHER INFORMATION CONTACT: Julie Sacramento Metropolitan Air Quality Evaluation Section, 1001 ‘‘I’’ Street, A. Rose, EPA Region IX, (415) 947– Management District (SMAQMD), San Sacramento, CA 95814. 4126, [email protected]. Bernardino County Air Pollution El Dorado County Air Pollution Control SUPPLEMENTARY INFORMATION: This Control District (now Mojave Desert Air District, 2850 Fairlane Court, Building proposal addresses the following local Quality Management District) C, Placerville, CA 95667–4100. rules:

TABLE 1.—SUBMITTED RULES

Local agency Rule No. Rule title Adopted Submitted

EDCAPCD ...... 1000 Emission Statement...... 09/21/92 11/12/92 FRAQMD ...... 4.8 Further Information...... 09/14/92 11/12/92 KCAPCD ...... 108.2 Emission Statement Requirements ...... 07/13/92 11/12/92 MDAQMD ...... 107 Certification and Emission Statements ...... 09/17/92 11/12/92 SMAQMD ...... 105 Emission Statement...... 04/20/93 11/18/93 SBCAPCD ...... 212 Emission Statements...... 10/20/92 11/12/92 YSAPCD ...... 3.18 Emission Statements...... 11/15/92 11/18/93

In the rules and regulations section of Dated: May 3, 2004. SUMMARY: This document seeks further this Federal Register, we are approving Wayne Nastri, comment on the Commission’s these local rules in a direct final action Regional Administrator, Region IX. presubscribed interexchange carrier without prior proposal because we [FR Doc. 04–11770 Filed 5–25–04; 8:45 am] (PIC)-change charge policies. PIC- believe these SIP revisions are not BILLING CODE 6560–50–P change charges are federally-tariffed controversial. If we receive adverse charges imposed by incumbent local comments, however, we will publish a exchange carriers on end-user timely withdrawal of the direct final FEDERAL COMMUNICATIONS subscribers when these subscribers rule and address the comments in COMMISSION change their presubscribed long subsequent action based on this distance carriers. In light of recent cost proposed rule. 47 CFR Chapter I information filed by BellSouth in support of an increase to its PIC-change We do not plan to open a second [CC Docket No. 02–53, FCC 04–96] charge, the further notice of proposed comment period, so anyone interested rulemaking seeks comment on creating in commenting should do so at this Presubscribed Interexchange Carrier separate PIC-change charges based on time. If we do not receive adverse Charges the method used to process the request. comments, no further activity is AGENCY: Federal Communications The further notice of proposed planned. For further information, please Commission. rulemaking also seeks comment on see the direct final action. whether, to encourage interexchange ACTION: Further notice of proposed carriers to utilize electronic processing, rulemaking. the charge should be assessed on the

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entity submitting the change request to analysis submitted in support of its request manually, possibly resulting in the local exchange carrier, either the tariff filing reflects that the percentage a higher charge to the end user. If the end user or the interexchange carrier. of manual processing has increased in end user instead requested the change The charge currently is imposed on the recent years. This filing raises questions through an IXC, however, either the end user. about the incentives that are created by lower mechanized PIC-change rate DATES: Comments due June 15, 2004 a PIC-change charge that does not could potentially apply, or the customer and reply comments due June 25, 2004. differentiate between electronic and could avoid paying a PIC-change charge FOR FURTHER INFORMATION CONTACT: manual processing. Therefore, as set at all if the charge was instead assessed Jennifer McKee, Wireline Competition forth below, we seek comment on on the IXC. If different PIC-change Bureau, Pricing Policy Division, (202) BellSouth’s filing, and whether and how charge rates are adopted, how should 418–1530. we should take account of the end-user customers be made aware of information in that filing in analyzing the different rates when they request a SUPPLEMENTARY INFORMATION: This is a our PIC-change charge policies and safe PIC change? Would different PIC-change summary of the Commission’s Further harbor. We also take this opportunity to charge rates improve or hinder Notice of Proposed Rulemaking (NPRM) refresh the record in this proceeding. consumers’ ability to understand how in CC Docket No. 02–53 released on BellSouth’s recently filed cost study charges are incurred? Would any benefit April 23, 2004. The full text of this indicates that manually processed PIC from adopting separate charges for document is available on the changes cost substantially more than electronic and manual processing Commission’s website Electronic mechanized PIC changes. BellSouth’s outweigh potential consumer confusion Comment Filing System and for public filing indicates that the costs of manual over the charges to be incurred when inspection during regular business PIC changes are cross-subsidized to switching providers? hours in the FCC Reference Center, some degree by the lower cost Consideration of separate charges Room CY–A257, 445 Twelfth Street, mechanized PIC changes because end raises the question of whether all SW., Washington, DC 20554. users pay a single rate regardless of how entities placing PIC-change orders will Background the PIC-change request is submitted. be able to submit orders using a Such subsidization will reduce carriers’ mechanized process. Can an end-user In this Further Notice of Proposed incentives to invest in the equipment customer currently change its PIC Rulemaking, adopted April 14, 2004 and necessary to submit mechanized PIC electronically through the LECs’ Web released April 23, 2004 in CC Docket change requests to the local exchange sites, or must a PIC change be processed No. 02–53, FCC 04–96, the Commission carriers (LECs). We therefore seek by a LEC (manually) or through an IXC is seeking to refresh the record and comment on whether there should be a (manually or mechanized)? Should specifically to seek comment on cost separate PIC-change charge (and carriers that do not make available to support information recently filed by associated safe harbor) for orders that end-user customers an option to submit BellSouth in support of its PIC-change require manual processing by a LEC and PIC changes directly through a charge increase. On March 20, 2002, the for orders that are submitted to a LEC mechanized system be precluded from Commission released a Notice of in a mechanized format. We also seek assessing a higher manual charge on its Proposed Rulemaking, 67 FR 34665, comment on whether manual versus end-user customers? May 15, 2002, in this proceeding mechanized processing of PIC changes Do separate charges for manual and seeking comment on the Commission’s is the correct categorization for any electronic processing raise anti- PIC-change charge policies, and on the multiple safe harbors, or whether other competitive issues that should be $5 PIC-change charge safe harbor. At the classifications of PIC-change charges addressed if the LEC is also providing time the Notice of Proposed Rulemaking should be adopted. We also seek long distance service? How much, if was released, BellSouth charged a PIC- comment on how small entities may be any, of the increase in the manual-to- change charge of $1.49, substantially affected by changes to our existing PIC- electronic processing ratio as set out in below the $5 safe harbor. BellSouth’s change charge policies. the BellSouth filing may be attributed to $1.49 PIC-change charge was supported To date, the PIC-change charge has the entrance of incumbent LECs in the by a cost study that had been filed in been assessed on end users. This long distance market? How do 1990. In the Notice of Proposed removes, to some extent, the incentive incumbent LEC long distance entities Rulemaking, the Commission sought for interexchange carriers (IXCs) to handle PIC-change requests? Are the comment on whether BellSouth’s $1.49 reduce the costs of PIC changes because requests processed by the long distance charge should be used in establishing a the charge is passed on to end users. entities, or are customers referred to the lower or upper bound on any future Should the charge instead be assessed local exchange entities to make the PIC-change charge safe harbor. on the entity that submits the order to change? Will these processes change Comments on the Notice of Proposed the LEC, i.e., if an IXC submits the when incumbent LEC local and long Rulemaking were due on June 14, 2002 order, the LEC would assess the charge distance operations are integrated after and reply comments were due on July on the IXC, and if an end user submits the sunset of the separate affiliate 1, 2002. Since the record closed on the the order to the LEC directly, the LEC requirements of section 272 of the Act, Notice of Proposed Rulemaking, would assess the charge on the end 47 U.S.C. 272? BellSouth has filed with the user? BellSouth’s recent PIC-change charge Commission a tariff revision, with the If there are separate charges for tariff filing reflects weighted costs of requisite cost support, that increased its electronic and manual processing, or if $2.45 for a manual PIC change and PIC-change charge from $1.49 per the charge or charges are assessed on the $0.48 for a mechanized PIC change. change to $3.07 per change. entity placing the order, customers will These costs, multiplied by a common need to be made aware of their options cost factor of 1.0497, yield BellSouth’s Discussion regarding PIC changes and what they total PIC change cost of $3.07. Should BellSouth’s tariff filing highlights the can do to pay a lower PIC-change we adopt a PIC-change charge safe significant disparity in costs for manual charge. For example, if an end-user harbor (or harbors) based on the and electronic (mechanized) processing customer calls a LEC requesting a PIC BellSouth cost study? Is the cost of PIC-change charges. BellSouth’s change, the LEC will have to enter the information submitted by BellSouth in

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its tariff filing typical for similarly 104–121, Title II, 110 Stat. 857 (1996). We have included small incumbent situated carriers? If the BellSouth cost Written public comments are requested LECs in this present RFA analysis. As study is used as a basis for setting a PIC- on this IRFA. Comments must be noted above, a ‘‘small business’’ under change charge safe harbor (or harbors), identified as responses to the IRFA and the RFA is one that, inter alia, meets the should the study be revised in any way? must be filed by the deadlines for pertinent small business size standard For example, customers are entitled to comments on the FNPRM. The (e.g., a wired telecommunications one initial free PIC preselection. Commission will send a copy of the carrier having 1,500 or fewer Therefore, is it appropriate to recover FNPRM, including this IRFA, to the employees), and ‘‘is not dominant in its costs for new installations in the PIC- Chief Counsel for Advocacy of the Small field of operation.’’ 5 U.S.C. 601(3). The change charge? Business Administration (SBA). See 5 SBA’s Office of Advocacy contends that, Some customers request a ‘‘PIC U.S.C. 603(a). In addition, the FNPRM for RFA purposes, small incumbent freeze’’ from their LEC. A PIC freeze and IRFA (or summaries thereof) will be LECs are not dominant in their field of prevents a change in a subscriber’s published in the Federal Register. operation because any such dominance preferred carrier selection unless the is not ‘‘national’’ in scope. See Letter Need for, and Objectives of, the subscriber gives the carrier from whom from Jere W. Glover, Chief Counsel for Proposed Rules the freeze was requested his or her Advocacy, SBA, to William E. Kennard, express written or oral consent. Should In this FNPRM, the Commission seeks Chairman, FCC (May 27, 1999). The the additional costs of processing PIC additional comment on its policies for Small Business Act contains a definition changes to customers with PIC freezes regulating PIC-change charges. of ‘‘small business concern,’’ which the be recovered through the PIC-change Specifically, we seek comment on RFA incorporates into its own definition charge, or through a separate PIC-freeze whether there should be separate PIC- of ‘‘small business.’’ See 15 U.S.C. charge? What entity should be change charges for manual and 632(a) (Small Business Act); 5 U.S.C. responsible for paying any additional electronic processing of change 601(3) (RFA). SBA regulations interpret charges associated with changing PIC- requests, and on whether the charge ‘‘small business concern’’ to include the freeze customers’ PICs? should be assessed on the entity that concept of dominance on a national Finally, given the passage of time places the order. We also seek comment basis. 13 CFR 121.102(b). We have since the record in this proceeding on recent PIC-change charge cost therefore included small incumbent closed, parties may refresh the record information filed by BellSouth. We seek LECs in this RFA analysis, although we with any new information or arguments comment on these issues, as well as any emphasize that this RFA action has no that they believe to be relevant to alternative means of ensuring the effect on Commission analyses and deciding the issues raised in this reasonableness of PIC-change charges. determinations in other, non-RFA proceeding. contexts. Legal Basis Wired Telecommunications Carriers. Procedural Matters The SBA has developed a small This FNPRM is adopted pursuant to Ex Parte Requirements business size standard for Wired sections 1, 4(i), 4(j), 201–205, and 303 Telecommunications Carriers, which This matter shall be treated as a of the Communications Act of 1934, as consists of all such companies having ‘‘permit-but-disclose’’ proceeding i006n amended, 47 U.S.C. 151, 154(i), (j), 201– 1,500 or fewer employees. 13 CFR accordance with the Commission’s ex 205, and 303. 121.201, NAICS code 513310 (changed parte rules, 47 CFR 1.1200 et seq. Description and Estimate of the Number to 517110 in October 2002). According Persons making oral ex parte of Small Entities to Which the Proposed to Census Bureau data for 1997, there presentations are reminded that Rules Will Apply were 2,225 firms in this category, total, memoranda summarizing the that operated for the entire year. Of this presentations must contain summaries The RFA directs agencies to provide total, 2,201 firms had employment of of the substance of the presentations a description of, and, where feasible, an 999 or fewer employees, and an and not merely a listing of the subjects estimate of the number of small entities additional 24 firms had employment of discussed. More than a one-or two- that will be affected by the proposed 1,000 employees or more. The census sentence description of the views and rules, if adopted. 5 U.S.C. 603(b)(3). The data do not provide a more precise arguments presented generally is RFA generally defines the term ‘‘small estimate of the number of firms that required. See 47 CFR 1.1206(b)(2). Other entity’’ as having the same meaning as have employment of 1,500 or fewer requirements pertaining to oral and the terms ‘‘small business,’’ ‘‘small employees; the largest category written presentations are set forth in organization,’’ and ‘‘small governmental provided is ‘‘Firms with 1,000 section 1.1206(b) of the Commission’s jurisdiction.’’ 5 U.S.C. 601(6). For the employees or more.’’ Thus, under this rules, 47 CFR 1.1206(b). purposes of this NPRM, the RFA defines size standard, the majority of firms can a ‘‘small business’’ to be the same as a Initial Regulatory Flexibility Act be considered small. ‘‘small business concern’’ under the Local Exchange Carriers. Neither the Analysis Small Business Act, 15 U.S.C. 632, Commission nor the SBA has developed As required by the Regulatory unless the Commission has developed a size standard for small businesses Flexibility Act of 1980, as amended one or more definitions that are specifically applicable to local exchange (RFA), 5 U.S.C. 603, the Commission appropriate to its activities. 5 U.S.C. services. The closest applicable size has prepared this Initial Regulatory 601(3) (incorporating by reference the standard under SBA rules is for Wired Flexibility Analysis (IRFA) of the definition of ‘‘small business concern’’ Telecommunications Carriers. Under possible significant economic impact on in 5 U.S.C. 632). Under the Small that size standard, such a business is a substantial number of small entities by Business Act, a ‘‘small business small if it has 1,500 or fewer employees. the policies and rules proposed in this concern’’ is one that: (1) is 13 CFR 121.201, NAICS code 513310 FNPRM. The RFA, see 5 U.S.C. 601 et independently owned and operated; (2) (changed to 517110 in October 2002). seq., has been amended by the Small is not dominant in its field of operation; According to Commission data, 1,337 Business Regulatory Enforcement and (3) meets any additional criteria carriers reported that they were Fairness Act of 1996 (SBREFA), Pub. L. established by the SBA. 15 U.S.C. 632. incumbent local exchange service

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providers. Trends in Telephone Service, reasonable PIC-change charges, or manual processing charge or a lower Federal Communications Commission, whether these charges must be electronic processing charge based on Wireline Competition Bureau, Industry regulated. If we find that the market how they submit the order to the LEC. Analysis and Technology Division, reasonably sets these charges, there will We also are seeking comment on how Table 5.3 (Aug. 2003) (Trends in be no additional reporting or small entities may be affected by Telephone Service). Of these 1,337 recordkeeping burden on incumbent changes to our existing PIC-change carriers, an estimated 1,032 have 1,500 LECs with respect to these charges. If we charge policies. or fewer employees and 305 have more determine that the market will not than 1,500 employees. Trends in successfully constrain PIC-change Federal Rules That May Duplicate, Telephone Service, Table 5.3. In charges, we must determine whether to Overlap, or Conflict With the Proposed addition, according to Commission data, establish a safe harbor below which PIC- Rules 609 companies reported that they were change charges are to be deemed None. engaged in the provision of either reasonable, or whether these charges competitive access provider services or should be cost-based. If we adopt a safe Filing of Comments and Reply competitive local exchange carrier harbor, incumbent LECs will be in the Comments services. Trends in Telephone Service, same situation as under the current Pursuant to sections 1.415 and 1.419 Table 5.3. Of these 609 companies, an rules, i.e., PIC-change charges tariffed at of the Commission’s rules, 47 CFR estimated 458 have 1,500 or fewer rates below the safe harbor are deemed 1.415, 1.419, interested parties may file employees and 151 have more than reasonable, and LECs have the option of comments on or before June 15, 2004, 1,500 employees. Trends in Telephone charging more if they can demonstrate and reply comments on or before June Service, Table 5.3. In addition, 35 that their costs for PIC changes exceed 25, 2004. Comments may be filed using carriers reported that they were ‘‘Other that rate. If we decide not to adopt a safe the Commission’s Electronic Comment Local Exchange Carriers.’’ Trends in harbor and require incumbent LECs to Filing System (ECFS) or by filing paper Telephone Service, Table 5.3. Of the 35 set PIC-change charges at cost, copies. ‘‘Other Local Exchange Carriers,’’ an incumbent LECs will be required to file Comments filed through the ECFS can estimated 34 have 1,500 or fewer information demonstrating the costs of be sent as an electronic file via the employees and one has more than 1,500 providing PIC changes. Internet to http://www.fcc.gov/cgb/ecfs/. employees. Trends in Telephone Steps Taken To Minimize Significant Generally, only one copy of an Service, Table 5.3. Consequently, the Economic Impact on Small Entities, and electronic submission must be filed. If Commission estimates that most Significant Alternatives Considered multiple docket or rulemaking numbers providers of local exchange service, appear in the caption of a proceeding, The RFA requires an agency to competitive local exchange service, however, commenters must transmit describe any significant, specifically competitive access providers, and one electronic copy of the comments to small business, alternatives that it has ‘‘Other Local Exchange Carriers’’ are each docket or rulemaking number small entities that may be affected by considered in reaching its proposed approach, which may include the referenced in the caption. In completing the rules and policies adopted herein. the transmittal screen, commenters Interexchange Carriers. Neither the following four alternatives (among should include their full name, U.S. Commission nor the SBA has developed others): (1) The establishment of Postal Service mailing address, and the a size standard for small businesses differing compliance or reporting applicable docket or rulemaking specifically applicable to interexchange requirements or timetables that take into number. Parties may also submit an services. The closest applicable size account the resources available to small electronic comment by Internet e-mail. standard under SBA rules is for Wired entities; (2) the clarification, To get filing instructions for e-mail Telecommunications Carriers. Under consolidation, or simplification of comments, commenters should send an that size standard, such a business is compliance or reporting requirements e-mail to [email protected], and should small if it has 1,500 or fewer employees. under the rule for small entities; (3) the 13 CFR 121.201, NAICS code 513310 use of performance, rather than design include the following words in the body (changed to 517110 in October 2002). standards; and (4) an exemption from of the message, ‘‘get form.’’ A sample According to Commission data, 261 coverage of the rule, or any part thereof, form and directions will be sent in companies reported that they were for small entities. 5 U.S.C. 603(c)(1)– reply. Parties who choose to file by interexchange carriers. Trends in (c)(4). paper must file an original and four Telephone Service, Table 5.3. Of these We are seeking comment on copies of each filing. If more than one 261 companies, an estimated 223 have alternative methods of setting a PIC- docket or rulemaking number appear in 1,500 or fewer employees and 38 have change charge, including whether the caption of a proceeding, commenters more than 1,500 employees. Trends in market forces will successfully must submit two additional copies for Telephone Service, Table 5.3. constrain these charges, and whether to each additional docket or rulemaking Consequently, the Commission adopt a safe harbor below which rates number. estimates that the majority of are presumed reasonable. These Filings can be sent by hand or interexchange service providers are proposals would reduce the reporting messenger delivery, by commercial small entities that may be affected by and recordkeeping burden on all overnight courier, or by first-class or the rules and policies adopted herein. incumbent LECs, including small LECs. overnight U.S. Postal Service mail We also are seeking comment on (although we continue to experience Description of Projected Reporting, whether to assess the PIC-change charge delays in receiving U.S. Postal Service Recordkeeping and Other Compliance on the entity making the change request, mail). Requirements which could be the IXC. We also are The Commission’s contractor, Natek, As described in the previous Initial seeking comment on whether to create Inc., will receive hand-delivered or Regulatory Flexibility Analysis in this separate PIC-change charges for manual messenger-delivered paper filings for proceeding, 67 FR 34665, May 15, 2002, and electronic processing of PIC the Commission’s Secretary at 236 we are seeking comment on whether we changes. This would allow IXCs to Massachusetts Avenue, NE., Suite 110, can rely on market forces to set control whether they paid a higher Washington, DC 20002.

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—The filing hours at this location are 8 Federal Communications Commission. FOR FURTHER INFORMATION CONTACT: a.m. to 7 p.m. Marlene H. Dortch, Rolanda F. Smith, Media Bureau, (202) —All hand deliveries must be held Secretary. 418–2180. together with rubber bands or [FR Doc. 04–11657 Filed 5–25–04; 8:45 am] SUPPLEMENTARY INFORMATION: This is a fasteners. BILLING CODE 6712–01–P summary of the Commission’s Notice of —Any envelopes must be disposed of Proposed Rule Making, MB Docket No. before entering the building. 04–164, adopted April 30, 2004, and —Commercial overnight mail (other FEDERAL COMMUNICATIONS released May 4, 2004. The full text of than U.S. Postal Service Express Mail COMMISSION and Priority Mail) must be sent to this Commission decision is available for inspection and copying during 9300 East Hampton Drive, Capitol 47 CFR Part 73 Heights, MD 20743. normal business hours in the —U.S. Postal Service first-class mail, Commission’s Reference Center 445 Express Mail, and Priority Mail [DA 04–1198, MB Docket No. 04–164, RM– Twelfth Street, SW., Washington, DC 10548] should be addressed to 445 12th 20554. The complete text of this Street, SW., Washington, DC 20554. decision may also be purchased from Radio Broadcasting Services; Corning, the Commission’s duplicating —All filings must be addressed to the Quincy and Susanville, CA Commission’s Secretary, Office of the contractor, Qualex International Portals Secretary, Federal Communications AGENCY: Federal Communications II, 445 12th Street, SW., Room CY-B402, Commission. Commission. Washington, DC 20554, telephone 202– 863–2893, facsimile 202–863–2898, or Parties shall also serve one copy with ACTION: Proposed rule. Qualex International, Portals II, 445 via e-mail [email protected]. 12th Street, SW., Room CY–B402, SUMMARY: This document requests Provisions of the Regulatory Washington, DC 20554, (202) 863–2893, comments on a petition filed by Corey Flexibility Act of l980 do not apply to or via e-mail to . J. McCaslin proposing the allotment of this proceeding. Parties are strongly encouraged to file Channel 262A at Susanville, California, Members of the public should note comments electronically using the as its fourth FM broadcast aural that from the time a Notice of Proposed Commission’s Electronic Comment transmission service. Channel 262A can Rule Making is issued until the matter Filing System (ECFS). Parties are also be allotted to Susanville, consistent is no longer subject to Commission requested to send a courtesy copy of with the minimum distance separation consideration or court review, all ex their comments via e-mail to requirements of the Commission’s Rules parte contacts are prohibited in [email protected]. If parties file using city reference coordinates. The Commission proceedings, such as this paper copies, parties are requested to reference coordinates for Channel 262A one, which involve channel allotments. send two (2) copies of the comments at Susanville are 40–24–59 North See 47 CFR 1.1204(b) for rules and reply comments to Chief, Pricing Latitude and 120–39–07 West governing permissible ex parte contact. Policy Division, Wireline Competition Longitude. Additionally, to For information regarding proper Bureau, Federal Communications accommodate the proposed allotment of filing procedures for comments, see 47 Commission, 445 12th Street, SW., Channel 262A at Susanville, Corey J. CFR 1.415 and 1.420. Room 5–A221, Washington, DC 20554. McCaslin requests the substitution of List of Subjects in 47 CFR Part 73 Documents in CC Docket No. 02–53 Channel 265A for Channel 262A at are available for public inspection and Quincy, California, and modification of Radio, Radio broadcasting. copying during business hours at the the license for Station KHGQ(FM) at its For the reasons discussed in the Federal Communications Commission current transmitter site. An Order to preamble, the Federal Communications Reference Information Center, Portals II, Show Cause is issued to Keily Miller, Commission proposes to amend 47 CFR 445 12th St. SW., Room CY–A257, licensee of Station KHGQ(FM), as part 73 as follows: Washington, DC 20554. The documents requested. To accommodate the may also be purchased from Qualex allotment of Channel 265A at Quincy, PART 73—RADIO BROADCAST International, telephone (202) 863–2893, Corey J. McCaslin also proposes the SERVICES facsimile (202) 863–2898. downgrade of Station KTHU(FM), 1. The authority citation for part 73 Ordering Clauses Channel 264C1, Corning, California to Channel 264B. The FM Table of continues to read as follows: It is ordered that, pursuant to the Allotments was recently changed to Authority: 47 U.S.C. 154, 303, 334 and 336. authority contained in sections 1, 4(i), reflect Channel 264B at Corning, 4(j), 201–205, and 303 of the § 73.202 [Amended] California. See 68 FR 60043, published Communications Act of 1934, as October 21, 2003. 2. Section 73.202(b), the Table of FM amended, 47 U.S.C. 151, 154(i), (j), 201– DATES: Comments must be filed on or Allotments under California, is 205, and 303, the further notice of amended by adding Channel 265A and proposed rulemaking is adopted. before June 25, 2004, and reply comments on or before July 12, 2004. removing Channel 262A at Quincy; and It is further ordered that the by adding Channel 262A at Susanville. Commission’s Consumer Information ADDRESSES: Federal Communications Bureau, Reference Information Center, Commission, 445 Twelfth Street, SW., Federal Communications Commission. shall send a copy of this Further Notice Washington DC 20554. In addition to John A. Karousos, of Proposed Rulemaking, including the filing comments with the FCC, Assistant Chief, Audio Division, Media Initial Regulatory Flexibility Analysis, interested parties should serve the Bureau. to the Chief Counsel for Advocacy of the petitioner, as follows: Corey J. McCaslin, [FR Doc. 04–11919 Filed 5–25–04; 8:45 am] Small Business Administration. P.O. Box 7612, Chico, California 95927. BILLING CODE 6712–01–P

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Notices Federal Register Vol. 69, No. 102

Wednesday, May 26, 2004

This section of the FEDERAL REGISTER Dated: May 19, 2004. information collection should be sent contains documents other than rules or Joanne Paskar, within 30 days of publication of this proposed rules that are applicable to the Chief, Information and Records Division, notice to David Rostker, OMB Desk public. Notices of hearings and investigations, Office of Administrative Services, Bureau for Officer, Room 10202, New Executive committee meetings, agency decisions and Management. Office Building, Washington, DC 20230. rulings, delegations of authority, filing of petitions and applications and agency [FR Doc. 04–11870 Filed 5–25–04; 8:45 am] Dated: May 20, 2004. statements of organization and functions are BILLING CODE 6116–01–M Madeleine Clayton, examples of documents appearing in this Management Analyst, Office of Management section. and Organization. DEPARTMENT OF COMMERCE [FR Doc. 04–11826 Filed 5–25–04; 8:45 am] AGENCY FOR INTERNATIONAL Submission for OMB Review; BILLING CODE 3510–33–P DEVELOPMENT Comment Request Notice of Public Information Collection The Department of Commerce (DOC) DEPARTMENT OF COMMERCE Requirements Submitted to OMB for has submitted to the Office of [I.D. 052104B] Review Management and Budget (OMB) for clearance the following proposal for Submission for OMB Review; SUMMARY: U.S. Agency for International collection of information under Comment Request Development (USAID) has submitted provisions of the Paperwork Reduction the following information collection to Act (44 U.S.C. Chapter 35). The Department of Commerce has OMB for review and clearance under the Agency: Bureau of Industry and submitted to the Office of Management Paperwork Reduction Act of 1995, Security (BIS). and Budget (OMB) for clearance the Public Law 104–13. Comments Title: Special Comprehensive License. following proposal for collection of regarding this information collection are Agency Form Number: BIS–748P, information under the provisions of the best assured of having their full effect if BIS–752. Paperwork Reduction Act (44 U.S.C. received within 30 days of this OMB Approval Number: 0694–0089. Chapter 35). notification. Comments should be Type of Request: Extension of a Agency: National Oceanic and addressed to: Desk Officer for USAID, currently approved collection of Atmospheric Administration (NOAA). Office of Information and Regulatory information. Title: Socio-economic Assessment of Affairs, Office of Management and Burden: 1,017 hours. Marine Protected Areas Management Budget (OMB), Washington, DC 20503. Average Time Per Response: 50 Preferences. Copies of submission may be obtained minutes to 40 hours per response. Form Number(s): None. by calling (202) 712–1365. Number of Respondents: 176 OMB Approval Number: None. respondents. Type of Request: Regular submission. SUPPLEMENTARY INFORMATION: Needs and Uses: The SCL Procedure Burden Hours: 700. OMB Number: OMB 0412–0506. authorizes multiple shipments of items Number of Respondents: 700. Form Number: AID 1420–50. from the U.S. or from approved Average Hours Per Response: 1. Title: Vendor Data Base (formerly consignees abroad who are approved in Needs and Uses: Several studies have known as USAID Consultant Registry advance by BIS to conduct the following shown that the haphazard placement of Information System (ACRIS)) activities: servicing, support services, traps damages hard corals and Instruction Books for the Organization stocking spare parts, maintenance, gorgonians. In addition, to physically Profile. capital expansion, manufacturing, damaging hard corals and gorgonians Type of Submission: Renew. support scientific data acquisition, traps target various over-exploited reef fish species, which further threaten the Purpose: USAID procuring activities reselling and reexporting in the form health and stability of coral reef are required to establish bidders mailing received, and other activities as habitats. In order to protect coral reef lists to assure access to sources and to approved on a case-by-case basis. habitats and ensure the sustainable use obtain meaningful competition (41 CFR Affected Public: Individuals, reef fish resources, the Caribbean 1–2.205). In compliance with this businesses or other for-profit Fishery Management Council (CFMC) is requirement, USAID’s Office of Small institutions. considering limiting the total number of and Disadvantaged Business Utilization/ Respondent’s Obligation: Required to traps in the fishery. The goal of the Minority Resource Center has obtain or retain benefits. proposed survey is to gather responsibility for developing and OMB Desk Officer: David Rostker. Copies of the above information socioeconomic information on the maintaining a Contractor’s Index of collection proposal can be obtained by Caribbean (Puerto Rico, St. Thomas, St. bidders/offerors capable of furnishing calling or writing Diana Hynek, John, and St. Croix) trap fishery to services for use by the USAID procuring Departmental Paperwork Clearance support the management and activities. (AIDAR 719.271–2(b)(4)). Officer, (202) 482–3129, Department of conservation efforts of the CFMC. The Annual Reporting Burden: Commerce, Room 6625, 14th and information collected will be used to Respondents: 1,000. Constitution Avenue, NW., Washington, satisfy regulatory objectives and Total annual responses: 1,000. DC 20230. analytical requirements, and to assist Total annual hours requested: 250 Written comments and the CFMC in selecting policies that meet hours. recommendations for the proposed conservation and management goals and

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minimize to the extent possible any there is limited to no observer coverage ADDRESSES: Direct all written comments adverse economic impacts on fishery of pot gear fisheries, NOAA Fisheries to Diana Hynek, Departmental participants. relies on the U.S. Coast Guard, fishing Paperwork Clearance Officer, Affected Public: Business or other for- industry, stranding network, federal , Department of Commerce, Room 6625, profit organizations. state, and local authorities, and the 14th and Constitution Avenue, NW., Frequency: One-time survey. public for this information. Washington, DC 20230 (or via the Respondent’s Obligation: Voluntary. The information provided will help Internet [email protected]). OMB Desk Officer: David Rostker, NOAA Fisheries better assess pot gear FOR FURTHER INFORMATION CONTACT: (202) 395-3897. fisheries (lobster, whelk/conch, crab, Requests for additional information or Copies of the above information fish trap) and their impact on sea turtle copies of the information collection collection proposal can be obtained by populations in the northeast region instrument(s) and instructions should calling or writing Diana Hynek, (Maine to Virginia). be directed to Karen Woods, Census Departmental Paperwork Clearance Affected Public: Business or other for- Bureau, FOB 3, Room 3340, Officer, (202) 482–0266, Department of profit organizations; Individuals or Washington, DC 20233–8400, (301) 763– Commerce, Room 6625, 14th and households; Not-for-profit institutions; 3806. Constitution Avenue, NW, Washington, Federal Government; and State, Local or SUPPLEMENTARY INFORMATION: DC 20230 (or via the Internet at Tribal Government. [email protected]). Frequency: On occasion. I. Abstract Written comments and Respondent’s Obligation: Voluntary. OMB Desk Officer: David Rostker, The Census Bureau plans to request recommendations for the proposed clearance for the collection of data information collection should be sent (202) 395–3897. Copies of the above information concerning the School Enrollment within 30 days of publication of this Supplement to be conducted in notice to David Rostker, OMB Desk collection proposal can be obtained by calling or writing Diana Hynek, conjunction with the October 2004 CPS. Officer, FAX number 202–395–7285, or Title 13, United States Code, Section [email protected]. Departmental Paperwork Clearance Officer, (202) 482–0266, Department of 182, and Title 29, United States Code, Dated: May 19, 2004. Commerce, Room 6625, 14th and Sections 1–9, authorize the collection of Gwellnar Banks, Constitution Avenue, NW, Washington, the CPS information. The Census Management Analyst, Office of the Chief DC 20230 (or via the Internet at Bureau and the Bureau of Labor Information Officer. [email protected]). Statistics (BLS) sponsor the basic annual [FR Doc. 04–11908 Filed 5–25–04; 8:45 am] Written comments and school enrollment questions, which BILLING CODE 3510–22–S recommendations for the proposed have been collected annually in the CPS information collection should be sent by for 40 years. May 27, 2004 to David Rostker, OMB This survey provides information on DEPARTMENT OF COMMERCE Desk Officer, FAX number 202–395– public/private elementary school, [I.D. 052104D] 7285, or [email protected]. secondary school, and college enrollment, and on characteristics of Dated: May 19, 2004. private school students and their Submission for OMB Review; Gwellnar Banks, Comment Request families, which is used for tracking Management Analyst, Office of the Chief historical trends, policy planning, and The Department of Commerce has Information Officer. support. This year’s supplement will submitted to the Office of Management [FR Doc. 04–11910 Filed 5–25–04; 8:45 am] also contain questions that were last and Budget (OMB) for emergency BILLING CODE 3510–22–S asked in October 1999. These questions clearance the following proposal for concern language proficiency, collection of information under the disabilities, and grade retention for DEPARTMENT OF COMMERCE provisions of the Paperwork Reduction persons 3–24 years of age. This survey Act (44 U.S.C. Chapter 35). Census Bureau is the only source of national data on Agency: National Oceanic and the age distribution and family Atmospheric Administration (NOAA). Current Population Survey (CPS) characteristics of college students and Title: Reporting of Sea Turtle School Enrollment Supplement the only source of demographic data on Entanglement in Pot Gear Fisheries. preprimary school enrollment. As part Form Number(s): None. AGENCY: Census Bureau, Department of of the federal government’s efforts to OMB Approval Number: None. Commerce. collect data and provide timely Type of Request: Emergency. ACTION: Proposed collection; comment information to local governments for Burden Hours: 30. request. policymaking decisions, the survey Number of Respondents: 15. provides national trends in enrollment SUMMARY: The Department of Average Hours Per Response: 60 and progress in school. minutes for a telephone call. Commerce, as part of its continuing Needs and Uses: This collection of effort to reduce paperwork and II. Method of Collection information involves Sea turtles respondent burden, invites the general The school enrollment information becoming accidentally entangled in public and other federal agencies to take will be collected by both personal visit active or discarded fixed fishing gear. this opportunity to comment on and telephone interviews in conjunction These entanglements may prevent the proposed and/or continuing information with the regular October CPS recovery of endangered and threatened collections, as required by the interviewing. All interviews are sea turtle populations. NOAA Fisheries Paperwork Reduction Act of 1995, conducted using computer-assisted has established the Sea Turtle Public Law 104–13 (44 U.S.C. interviewing. Disentanglement Network to promote 3506(c)(2)(A)). III. Data reporting and increase successful DATES: Written comments must be disentanglement of sea turtles. Since submitted on or before July 26, 2004. OMB Number: 0607–0464.

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Form Number: There are no forms. Paperwork Reduction Act of 1995, ways to enhance the quality, utility, and We conduct all interviews on Public Law 104–13 (44 U.S.C. clarity of the information to be computers. 3506(c)(2)(A)). collected; and (d) ways to minimize the Type of Review: Regular. DATES: Written comments must be burden of the collection of information Affected Public: Households. submitted on or before July 26, 2004. on respondents, including through the Estimated Number of Respondents: use of automated collection techniques ADDRESSES: Direct all written comments 57,000. or other forms of information to Diana Hynek, Departmental Estimated Time Per Response: 8 technology. minutes. Paperwork Clearance Officer, Office of Comments submitted in response to Estimated Total Annual Burden the Chief Information Officer, this notice will be summarized and/or Hours: 7,600. Department of Commerce, Room 6625, included in the request for OMB Estimated Total Annual Cost: The 14th and Constitution Avenue, NW, approval of this information collection; only cost to respondents is that of their Washington DC 20230. they will also become a matter of public time. FOR FURTHER INFORMATION CONTACT: record. Respondent’s Obligation: Voluntary. Requests for additional information or Dated: May 20, 2004. copies of the information collection Legal Authority: Title 13, U.S.C., Section Madeleine Clayton, 182, and Title 29, U.S.C., Sections 1–9. instrument(s) and instructions should be directed to Stephen Baker, BIS ICB Management Analyst, Office of the Chief IV. Request for Comments Liaison, Projects and Planning Division, Information Officer. Comments are invited on: (a) Whether Department of Commerce, Room 6622, [FR Doc. 04–11825 Filed 5–25–04; 8:45 am] the proposed collection of information 14th and Constitution Avenue, NW, BILLING CODE 3510–DT–P is necessary for the proper performance Washington, DC, 20230. of the functions of the agency, including SUPPLEMENTARY INFORMATION: DEPARTMENT OF COMMERCE whether the information shall have I. Abstract practical utility; (b) the accuracy of the International Trade Administration agency’s estimate of the burden The record retention period (including hours and cost) of the corresponds with the five year statute of [A–570–846] proposed collection of information; (c) limitations for criminal actions brought ways to enhance the quality, utility, and under the Export Administration Act of Brake Rotors From the People’s clarity of the information to be 1979 and predecessor acts, and the five Republic of China: Initiation of collected; and (d) ways to minimize the year statute for administrative Eleventh New Shipper Antidumping burden of the collection of information compliance proceedings. Without this Duty Review on respondents, including through the authority, potential violators could AGENCY: Import Administration, use of automated collection techniques discard records demonstrating International Trade Administration, or other forms of information violations of the EAR prior to the Department of Commerce. technology. expiration of the five-year statute of SUMMARY: The Department of Commerce Comments submitted in response to limitations. received one request on December 15, this notice will be summarized and/or II. Method of Collection 2003, to conduct a new shipper review included in the request for the Office of of the antidumping duty order on brake Management and Budget approval of Recordkeeping. rotors from the People’s Republic of this information collection; they also III. Data China (‘‘PRC’’). In accordance with 19 will become a matter of public record. OMB Number: 0694–0096. CFR 351.214(d), we are initiating a new Dated: May 20, 2004. Form Number: Not applicable. shipper review for the company that Madeleine Clayton, Type of Review: Regular submission requested such a review: Longkou Management Analyst, Office of the Chief for extension of a currently approved Jinzheng Machinery Co., Ltd., a Information Officer. collection. producer and exporter of brake rotors [FR Doc. 04–11824 Filed 5–25–04; 8:45 am] Affected Public: Individuals, from the PRC. BILLING CODE 3510–07–P businesses or other for-profit and not- EFFECTIVE DATE: May 26, 2004. for-profit institutions. FOR FURTHER INFORMATION CONTACT: Estimated Number of Respondents: Brian Smith, Import Administration, DEPARTMENT OF COMMERCE 201,177. International Trade Administration, Estimated Time Per Response: .01 U.S. Department of Commerce, 14th Bureau of Industry and Security seconds to 1 minute per response. Street and Constitution Avenue, NW., Five-Year Record Retention Period Estimated Total Annual Burden Washington, DC 20230; telephone (202) Hours: 253. 482–1766. AGENCY: Bureau of Industry and Estimated Total Annual Cost: No SUPPLEMENTARY INFORMATION: Security, Commerce. start-up capital expenditures. Background ACTION: Proposed collection; comment IV. Request for Comments request. The Department received a timely Comments are invited on: (a) Whether request in December 2003 from Longkou SUMMARY: The Department of the proposed collection of information Jinzheng Machinery Co., Ltd. (‘‘Longkou Commerce, as part of its continuing is necessary for the proper performance Jinzheng’’) in accordance with 19 CFR effort to reduce paperwork and of the functions of the agency, including 351.214(c), for a new shipper review of respondent burden, invites the general whether the information shall have the antidumping duty order on brake public and other Federal agencies to practical utility; (b) the accuracy of the rotors from the PRC, which has an April take this opportunity to comment on agency’s estimate of the burden anniversary month. proposed and/or continuing information (including hours and cost) of the Longkou Jinzheng identified itself as collections, as required by the proposed collection of information; (c) the producer of the brake rotors it

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exports. As required by 19 CFR Initiation of Review DEPARTMENT OF COMMERCE 351.214(b)(2)(i) and (iii)(A), Longkou Jinzheng has certified that it did not In accordance with section International Trade Administration 751(a)(2)(B)(ii) of the Act and 19 CFR export brake rotors to the United States [A–570–848] during the period of investigation 351.214(d)(1), we are initiating a new (‘‘POI’’), and that it has never been shipper review of the antidumping duty Freshwater Crawfish Tail Meat From affiliated with any exporter or producer order on brake rotors from the PRC. the People’s Republic of China: which did export brake rotors during Normally, we would issue the Extension of Time Limit for Final the POI (see December 15, 2003, preliminary results of this review not Results of New Shipper Review submission). Longkou Jinzheng has later than 180 days after the date on further certified that its export activities which the review is initiated. However, AGENCY: Import Administration, are not controlled by the central on May 7, 2004, Longkou Jinzheng International Trade Administration, government of the PRC, satisfying the agreed to waive the time limits in order U.S. Department of Commerce. requirements of 19 CFR that the Department, pursuant to 19 CFR SUMMARY: The Department of Commerce 351.214(b)(2)(iii)(B). Pursuant to 19 CFR 351.214(j)(3), may conduct this review is extending the time limit for the final 351.214(b)(2)(iv)(A), Longkou Jinzheng concurrent with the seventh results of the new shipper review of the provided the date of the first sale to an administrative review of this order for antidumping duty order on freshwater unaffiliated customer in the United the period April 1, 2003, through March crawfish tail meat from the People’s States. Longkou Jinzheng submitted 31, 2004, which is being conducted Republic of China until no later than documentation establishing the date on pursuant to section 751(a)(1) of the Act. July 23, 2004. The period of review is which it first shipped the subject Therefore, we intend to issue the final September 1, 2002 through February 28, merchandise to the United States and results of this review not later than 245 2003. This extension is made pursuant the volume and date of entry of that days after the last day of the anniversary to section 751(a)(2)(B)(iv) of the Tariff shipment. month. Act of 1930, as amended (the Act). In accordance with section EFFECTIVE DATE: May 26, 2004. 751(a)(2)(B) of the Tariff Act of 1930 Antidumping duty new shipper Period to be FOR FURTHER INFORMATION CONTACT: (‘‘the Act’’), as amended, and 19 CFR review reviewed Thomas Gilgunn or Addilyn Chams- 351.214(b), and based on our analysis of Eddine, AD/CVD Enforcement Office 7, the information and documentation PRC: Brake Rotors, A–570– Import Administration, International provided with the new shipper review 846: Longkou Jinzheng Ma- Trade Administration, U.S. Department request, as well as our analysis of chinery Co., Ltd ...... 04/01/03– 03/31/04 of Commerce, 14th Street and proprietary import data from U.S. Constitution Avenue, NW., Washington, Customs and Border Protection (‘‘CBP’’), DC 20230; telephone: (202) 482–4236 or we find that Longkou Jinzheng has met We will instruct CBP to allow, at the (202) 482–0648, respectively. the requirements for the Department to option of the importer, the posting, until SUPPLEMENTARY INFORMATION: initiate a new shipper review (for more the completion of the review, of a bond details, see New Shipper Initiation or security in lieu of a cash deposit for Statutory Time Limits Checklist for Longkou Jinzheng). each entry of the subject merchandise Section 751(a)(2)(B)(iv) of the Act Therefore, we are initiating a new from Longkou Jinzheng. This action is requires the Department to issue the shipper review for Longkou Jinzheng. in accordance with section final results of a new shipper review In cases involving non-market 751(a)(2)(B)(iii) of the Act, as amended, within 90 days after the date on which economies, it is the Department’s and 19 CFR 351.214(e). Because the preliminary results were issued. normal practice to require that a Longkou Jinzheng has certified that it However, if the Department determines company seeking to establish eligibility both produces and exports the subject the issues are extraordinarily for an antidumping duty rate separate merchandise, the sale of which was the complicated, section 751(a)(2)(B)(iv) of from the country-wide rate provide de basis for its new shipper review request, the Act allows the Department to extend jure and de facto evidence of an absence we will apply the bonding privilege the deadline for the final results to up of government control over the only to entries of subject merchandise to 150 days after the date on which the company’s export activities (see Natural for which it is both the producer and preliminary results were issued. Bristle Paintbrushes and Brush Heads exporter. from the People’s Republic of China, 68 Background FR 57875 (October 7, 2003)). Interested parties that need access to On March 31, 2003, the Department Accordingly, we will issue a proprietary information in this new received a timely request for a new questionnaire to Longkou Jinzheng shipper review should submit shipper review under the antidumping (including a complete separate rates applications for disclosure under duty order on freshwater crawfish tail section), allowing approximately 37 administrative protective order in meat from the People’s Republic of days for response. If the response from accordance with 19 CFR 351.305 and China in accordance with § 751(a)(2)(B) Longkou Jinzheng provides sufficient 351.306. of the Act and § 351.214(c) of the indication that it is not subject to either This initiation and notice are in Department’s regulations from Shanghai de jure or de facto government control accordance with section 751(a)(2)(B) of Ocean Flavor International Trading Co., with respect to its exports of brake the Act (19 U.S.C. 1675(a)) and 19 CFR Ltd. (Shanghai Ocean Flavor). On April rotors, the review will proceed. If the 351.214(d). 30, 2003, the Department initiated this respondent does not demonstrate its Dated: May 20, 2004. new shipper review for the period eligibility for a separate rate, then it will September 1, 2002 through February 28, be deemed to be affiliated with other Jeffrey May, 2003. See Freshwater Crawfish Tail companies that exported during the POI Deputy Assistant Secretary for Import Meat From the People’s Republic of and that it did not establish entitlement Administration. China: Initiation of Antidumping Duty to a separate rate, and the review of that [FR Doc. 04–11916 Filed 5–25–04; 8:45 am] New Shipper Review, 68 FR 23962 (May respondent will be rescinded. BILLING CODE 3510–DS–P 6, 2003).

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On September 15, 2003, the § 751(a)(2)(B)(iv) of the Act and April 30, 2003, the Department Department extended the preliminary § 351.214(i)(2) of the regulations, the initiated this new shipper review for the results of this new shipper review by Department is extending the time limit period March 1, 2002, through February 120 days until February 24, 2004. See for the completion of final results to 150 28, 2003. See Glycine from the People’s Freshwater Crawfish Tail Meat From the days from the date on which the Republic of China: Initiation of People’s Republic of China: Extension of preliminary results were issued. The Antidumping New Shipper Review, 68 Time Limit of Preliminary Results of final results will now be due no later FR 23962 (May 6, 2003). The New Shipper Review, 68 FR 53960 than July 23, 2004. Department completed the preliminary (September 15, 2003). This notice is published pursuant to results of this new shipper review on On February 24, 2004, the Department sections 751(a)(2)(B) and 777(i)(1) of the February 24, 2004. See Notice of issued the preliminary results of this Act. Preliminary Results of Antidumping review. See Notice of the Preliminary Dated: May 20, 2004. Duty New Shipper Review: Glycine from Results of Antidumping Duty New Joseph A. Spetrini, the People’s Republic of China, 69 FR Shipper Review: Freshwater Crawfish 9804 (March 2, 2004). Tail Meat From the People’s Republic of Deputy Assistant Secretary for Import China, 69 FR 9800 (March 2, 2004). On Administration, Group III. Extension of Time Limits for Final April 5, 2004, the petitioners and [FR Doc. 04–11917 Filed 5–25–04; 8:45 am] Results respondent each submitted a case brief BILLING CODE 3510–DS–P Section 351.214(i)(1) of the for the Department’s consideration prior Department’s regulations requires the to the final determination in this new Department to issue final results of a DEPARTMENT OF COMMERCE shipper review. On April 12, 2004, new shipper review within 90 days after petitioners and respondent submitted a International Trade Administration the date on which the preliminary rebuttal brief to the Department. On results were issued. However, if the April 26, 2004, the Department sent a [A–570–836] Secretary concludes that a new shipper supplemental questionnaire to the review is extraordinarily complicated, respondent. On May 3, 2004, Notice of Extension of Time Limit of the Secretary may extend the 90–day respondent submitted its response to the Final Results of New Shipper Review: period to 150 days under section Department’s supplemental Glycine from the People’s Republic of 351.214(i)(2) of the Department’s questionnaire. At the request of China regulations. petitioners, the Department held a AGENCY: Import Administration, The Department finds that this new hearing on May 5, 2004. A portion of the International Trade Administration, shipper review is extraordinary hearing was conducted in closed session U.S. Department of Commerce. complicated, and the final results of this in accordance with § 351.310(f) of the SUMMARY: The Department of Commerce new shipper review cannot be Department’s regulations. (the Department) is extending the time completed within the normal time limit Extension of Time Limit for Final limit for the final results of the new because of the issue surrounding the Results shipper review of the antidumping duty bona fide nature of the sales under order on glycine from the People’s review, and information presented to Pursuant to section 751(a)(2)(B)(iv) of Republic of China (PRC) until no later the Department for the first time at the Act, the Department may extend the than July 23, 2004. The period of review verification. Therefore, in accordance deadline for completion of the final is March 1, 2002, through February 28, with section 751(a)(2)(B)(iv) of the Act results of a new shipper review if it 2003. This extension is made pursuant and section 351.214(i)(2) of the determines that the case is to section 751(a)(2)(B)(iv) of the Tariff Department’s regulations, the extraordinarily complicated. The Department is extending the time limit Department has determined that this Act of 1930, as amended (the Act). EFFECTIVE DATE: May 26, 2004. for the completion of final results to 150 case is extraordinarily complicated days. The final results will now be due FOR FURTHER INFORMATION CONTACT: because of the issues that must be no later than July 23, 2004. addressed regarding the bona fides of Christian Hughes or Matthew Renkey, This notice is published pursuant to the new shipper sales. Therefore, the AD/CVD Enforcement, Import sections 751(a)(2)(B) and 777(i)(1) of the final results of this new shipper review Administration, International Trade Act. cannot be completed within the Administration, U.S. Department of statutory time limit of 90 days. Because Commerce, 14th Street and Constitution Dated: May 20, 2004. the Department issued an additional Avenue, N.W., Washington D.C. 20230; Joseph A. Spetrini, supplemental questionnaire on April 26, telephone: (202) 482–0190 or (202) 482– Deputy Assistant Secretary for Import 2004, and the response to this 2312, respectively. Administration, Group III. supplemental questionnaire was filed SUPPLEMENTARY INFORMATION: [FR Doc. 04–11914 Filed 5–25–04; 8:45 am] on May 3, 2004, there is new BILLING CODE 3510–DS–S information relating to the bona fides of Background the new shipper sales. Thus, the On March 29, 1995, the Department Department must analyze the published in the Federal Register an DEPARTMENT OF COMMERCE information submitted by Shanghai antidumping duty order on glycine from Ocean Flavor in its supplemental the PRC. See Antidumping Duty Order: International Trade Administration questionnaire response and any Glycine from the People’s Republic of Postponement of Preliminary comments or additional factual China, 60 FR 16116 (March 29, 1995). In Determination of Antidumping Duty information which the petitioners may accordance with section 351.214(b) of Investigation: Outboard Engines From submit. Additionally, the Department the Department’s regulations, on March Japan (A–588–865) may find it necessary to request further 26, 2003, the Department received a information regarding the bona fides timely request for a new shipper review AGENCY: Import Administration, from the respondent in this new shipper from Hebei New Donghua Amino Acid International Trade Administration, review. Therefore, in accordance with Co. Ltd. (New Donghua). On Department of Commerce.

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SUMMARY: The Department of Commerce Dated: May 20, 2004. Freed (Panchmahal), Import (the Department) is postponing the Jeffrey May, Administration, International Trade preliminary determination in the Deputy Assistant Secretary for Import Administration, U.S. Department of antidumping duty investigation of Administration. Commerce, 14th and Constitution outboard engines from Japan until no [FR Doc. 04–11915 Filed 5–25–04; 8:45 am] Avenue, N.W., Washington, D.C. 20230; later than July 16, 2004. This BILLING CODE 3510–DS–P telephone: 202–482–1102, or 202–482– postponement is made pursuant to 4271, respectively. section 733(c)(1)(B) of the Tariff Act of SUPPLEMENTARY INFORMATION: 1930, as amended (the Act). DEPARTMENT OF COMMERCE Background EFFECTIVE DATE: May 26, 2004. International Trade Administration On December 19, 2003, the FOR FURTHER INFORMATION CONTACT: (A–533–808) Department published in the Federal James Kemp at (202) 482–5346 or Shane Register the preliminary results and Subler at (202) 482–0189, Import Stainless Steel Wire Rods From India: partial rescission of its administrative Administration, International Trade Final Results and Partial Rescission of review of the antidumping duty order Administration, U.S. Department of Antidumping Duty Administrative on stainless steel wire rods from India. Commerce, 14th Street and Constitution Review See Preliminary Results. We invited Avenue, NW., Washington, DC 20230. AGENCY: Import Administration, parties to comment on our preliminary SUPPLEMENTARY INFORMATION: International Trade Administration, results of review. We received Viraj’s U.S. Department of Commerce. case briefs on January 27, 2004. We Postponement of Due Date for received Mukand’s and Isibars’ case ACTION: Notice of final results and Preliminary Determination partial rescission of antidumping duty briefs on January 28, 2004. We received a brief from the petitioner alleging new On January 28, 2004, the Department administrative review of stainless steel wire rods from India. factual information contained in initiated an antidumping duty Mukand’s, Isibars’ and Viraj’s case briefs investigation of outboard engines from SUMMARY: On December 19, 2003, the on February 2, 2004. We received Japan. See Notice of Initiation of Department of Commerce (‘‘the rebuttal briefs to all three of the Antidumping Duty Investigation: Department’’) published in the Federal respondent’s briefs from petitioner, Outboard Engines from Japan, 69 FR Register the preliminary results of its dated February 6, 2004. Pursuant to 19 5316 (February 4, 2004). The notice of administrative review of the CFR 351.309(c)(ii), the Department initiation stated that we would issue our antidumping duty order on stainless directed Mukand, Isibars and Viraj to preliminary determination no later than steel wire rods from India. See Stainless resubmit their briefs and omit certain 140 days after the date of initiation. See Steel Wire Rods From India: Preliminary new factual information that was not Id. Currently, the preliminary Results and Partial Rescission of raised in a timely manner. See the determination in this investigation is Antidumping Duty Administrative Department’s letter dated February 24, due on June 16, 2004. Review, 68 FR 70765 (December 19, 2004, rejecting Mukand, Viraj and On April 30, 2004, the petitioner 1 2003) (‘‘Preliminary Results’’). This Isibars’ case briefs. Mukand, Isibars and made a timely request pursuant to 19 review covers Viraj Alloys Limited Viraj resubmitted new case briefs CFR 351.205(e) for a thirty-day (‘‘VAL’’) and VSL Wires Ltd. redacting the new information on postponement of the preliminary (‘‘VSL’’)(collectively ‘‘Viraj’’), Isibars February 26, 2004. We received a letter determination until July 16, 2004. The Limited (‘‘Isibars’’), and Mukand from the petitioner on March 5, 2004, petitioner requested postponement of Limited (‘‘Mukand’’), manufacturers and requesting the Department to complete the preliminary determination because exporters of subject merchandise to the and clarify the official record of the it believes additional time is necessary United States. Panchmahal Steel review by bringing additional to allow the petitioner to review the Limited (‘‘Panchmahal’’) was originally information into the official record. We responses to the questionnaire and other a respondent in this review, but the received Viraj’s submission containing materials submitted in this Department rescinded the review of this new information on March 30, investigation, to submit comments to Panchmahal based on the timely 2004. We received the complete public the Department, and to allow the withdrawal of the only request for version of Viraj’s submission on April 7, Department time to thoroughly analyze review of the company. See Preliminary 2004. We have now completed the the respondent’s data and to seek Results. The period of review is administrative review in accordance additional information, if necessary. December 1, 2001 through November with section 751 of the Tariff Act of For the reasons identified by the 30, 2002. 1930, as amended (‘‘the Act’’). petitioner, and because there are no Based on our analysis of the Scope of Review compelling reasons to deny the request, comments received regarding Viraj, we we are postponing the preliminary have made changes from the The merchandise under review is determination under section 733(c)(1) of preliminary results of review. Therefore, certain stainless steel wire rods the Act. Therefore, the preliminary the final results differ from the (‘‘SSWR’’), which are hot–rolled or hot– determination is now due no later than Preliminary Results with respect to the rolled annealed and/or pickled rounds, July 16, 2004. The deadline for the final weighted–average dumping margin for squares, octagons, hexagons or other determination will continue to be 75 Viraj. The final weighted–average shapes, in coils. SSWR are made of alloy days after the date of the preliminary dumping margin for the reviewed firms steels containing, by weight, 1.2 percent determination. This notice is issued and is listed below in the section entitled or less of carbon and 10.5 percent or published pursuant to sections 733(f) ‘‘Final Results of the Review.’’ more of chromium, with or without and 777(i) of the Act. EFFECTIVE DATE: May 26, 2004. other elements. These products are only FOR FURTHER INFORMATION CONTACT: manufactured by hot–rolling and are 1 The petitioner in this investigation is Mercury Jonathan Herzog (Mukand), Kit Rudd normally sold in coiled form, and are of Marine, a division of Brunswick Corporation. (Viraj), Eugene Degnan (Isibars), and Jon solid cross section. The majority of

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SSWR sold in the United States are under section 751 concerning the margin in that case as adverse best round in cross–section shape, annealed subject merchandise.’’ See SAA at 870. information available (the predecessor and pickled. The most common size 5.5 The SAA provides that to ‘‘corroborate’’ to facts available) because the margin millimeters in diameter. means simply that the Department will was based on another company’s The SSWR subject to this review are satisfy itself that the secondary uncharacteristic business expense currently classifiable under subheadings information to be used has probative resulting in an unusually high margin. 7221.00.0005, 7221.00.0015, value. Id. The SAA also states that Similarly, the Department does not 7221.00.0030, 7221.00.0045, and independent sources used to corroborate apply a margin that has been 7221.00.0075 of the Harmonized Tariff may include, for example, published discredited. See D&L Supply Co. v. Schedule of the United States (HTSUS). price lists, official import statistics and United States, 113 F.3d 1220, 1221 (Fed. Although the HTSUS subheadings are customs data, and information obtained Cir. 1997) (the Department will not use provided for convenience and customs from interested parties during the a margin that has been judicially purposes (as of March 1, 2003, renamed particular investigation. Id. As noted in invalidated). the U.S. Bureau of Customs and Border Tapered Roller Bearings and Parts There is no information on the record Protection), the written description of Thereof, Finished and Unfinished, from indicating that the rate used would be the merchandise under review is Japan, and Tapered Roller Bearings, inappropriate Further, the rate used is dispositive of whether or not the Four Inches or Less in Outside currently applicable to all exporters merchandise is covered by the review. Diameter, and Components Thereof, subject to the ‘‘All Others’’ rate. As the petition rate is both reliable Facts Available from Japan; Preliminary Results of Antidumping Duty Administrative and relevant, we determine that it has In the instant review, for the Reviews and Partial Termination of probative value. As a result, the preliminary results, the Department Administrative Reviews, 61 FR 57391, Department determines that the petition applied adverse facts available in 57392 (November 6, 1996), to rate is corroborated for the purposes of accordance with section 776(a) of the corroborate secondary information, the this administrative review and may Act to Isibars because Isibars failed to Department will, to the extent reasonably be applied to Isibars and provide or withheld information the practicable, examine the reliability and certain Mukand sales as a total adverse Department requested. See Preliminary relevance of the information used. facts available rate. Accordingly, we Results, 68 FR at 70767. The We have corroborated to the extent determine that the petition rate is in Department received inadequate practicable, the adverse facts available accord with section 776(c)’s responses to the questionnaire and rate we have applied in this review. See requirement that secondary information multiple supplemental questionnaires Corroboration Memorandum for the be corroborated (i.e., have probative from Isibars and could not verify the Final Results of the 2001–2002 value). incomplete information that Isibars did Administrative Review of Stainless Steel Consequently, we are applying a provide, which is necessary for the Wire Rods from India, dated May 17, single antidumping rate the highest rate margin analysis. See Preliminary 2004, (‘‘Corroboration Memo’’). In order from any segment of this administrative Results, 68 FR at 70767. Further, in to corroborate this rate, the Department proceeding to Isibars’ exports based on accordance with sesction 776(a) of the compared the petition’s quoted and Isibars’ failure to provide information Act, the Department applied partial adjusted export prices (‘‘EP’’) and home and reconciliations as requested by the adverse facts available to certain market price quotes, which serve as the Department, and certain Mukand sales. Mukand sales because Mukand failed to basis for normal value (‘‘NV’’), to U.S. See, e.g., Final Determination of Sales at provide or withheld information Customs data, and the Sections B and C Less Than Fair Value: Synthetic Indigo requested by the Department. See databases provided in this from the People’s Republic of China, 65 Preliminary Results, 68 FR at 70773. administrative review by Mukand and FR 25706, 25707 (May 3, 2000). Since we have received no new Viraj, where appropriate. See Analysis of Comments Received information since the preliminary Corroboration Memo at 2 and 3. results that contradicts the decision Comparing the U.S. Customs data and All issues raised in the case and made in the preliminary results of Mukand, we found that the EP prices in rebuttal briefs by parties to this review, we continue to apply adverse the petition were higher than the EP administrative review are addressed in facts available with respect to Isibars prices provided in the U.S. Customs the ‘‘Issues and Decision Memorandum’’ and partial adverse facts available with data and the EP prices provided by (‘‘Decision Memorandum’’) from Joseph respect to certain Mukand sales. Mukand. Further, the NV price per A. Spetrini, Deputy Assistant Secretary, pound as reported in the petition was Import Administration, to James J. Corroboration of Adverse Facts similar to the home market prices Jochum, Assistant Secretary for Import Available reported by Mukand. See Corroboration Administration, dated May 17, 2004, Section 776(c) of the Act provides Memo at 3. which is hereby adopted by this notice. that, when the Department relies on With respect to the relevance aspect A list of the issues which parties have secondary information rather than on of corroboration, the Department will raised and to which we have responded, information obtained in the course of an consider information reasonably at its all of which are in the Decision investigation as facts available, it must, disposal to determine whether a margin Memorandum, is attached to this notice to the extent practicable, corroborate continues to have relevance. Where as an Appendix. Parties can find a that information from independent circumstances indicate that the selected complete discussion of all issues raised sources reasonably at its disposal. margin is not appropriate as adverse in this review and the corresponding Secondary information is defined in the facts available, the Department will recommendations in the Decision Statement of Administrative Act disregard the margin and determine an Memorandum, which is on file in the (‘‘SAA’’) as ‘‘information derived from appropriate margin. For example, in Central Records Unit, Room B–099 of the petition that gave rise to the Fresh Cut Flowers from Mexico: Final the main Department building. In investigation or review, the final Results of Antidumping Administrative addition, a complete version of the determination concerning subject Review, 61 FR 6812 (February 22, 1996), Decision Memorandum can be accessed merchandise, or any previous review the Department disregarded the highest directly on the Web at http://

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ia.ita.doc.gov/frn/index.html. The paper Producer/Manufac- Weighted–Average 351.402(f)(2) to file a certificate copy and electronic version of the turer/Exporter Margin regarding the reimbursement of Decision Memorandum are identical in antidumping duties prior to liquidation content. Viraj ...... 0.0% of the relevant entries during this Mukand ...... 18.67% review period. Failure to comply with Sales Below Cost Isibars ...... 48.80% this requirement could result in the Secretary’s presumption that We disregarded sales that failed the The Department shall determine, and reimbursement of the antidumping cost test for Mukand and Viraj during U.S. Customs and Border Protection duties occurred and the subsequent the course of the review. We initiated a (‘‘CBP’’) shall assess, antidumping assessment of double antidumping sales below the cost of production duties on all appropriate entries. In duties. investigation with respect to Isibars. See accordance with 19 CFR 351.212(b)(1), the Department’s June 3, 2003 letter to we have calculated exporter/importer This notice also serves as a reminder Isibars initiating sales below cost of (or customer)-specific assessment rates to parties subject to administrative production investigation. However, for merchandise subject to this review. protective orders (‘‘APOs’’) of their because Isibars did not provide the The Department will issue appraisement responsibility concerning the return or Department with a complete cost instructions directly to CBP within 15 destruction of proprietary information database, the Department could not days of publication of these final results disclosed under APO in accordance conduct the dumping analysis, of review. We will direct CBP to assess with 19 CFR 351.305, which continues including the sales below cost the resulting assessment rates against to govern business proprietary investigation. For a complete discussion the entered customs values for the information in this segment of the of Isibars’ incomplete cost information subject merchandise on each of that proceeding. Timely written notification see Comment 1 of the Decision importer’s entries under the relevant of the return/destruction of APO Memorandum. order during the review period. For materials or conversion to judicial protective order is hereby requested. Changes Since the Preliminary Results duty–assessment purposes, we calculated importer–specific assessment Failure to comply with the regulations Based on our analysis of comments rates by dividing the dumping margins and terms of an APO is a violation received, we have made changes in the calculated for each importer by the total which is subject to sanction. margin calculations for Viraj. The entered value of sales for each importer We are issuing and publishing this changes to the margin calculations are during the period of review. determination and notice in accordance listed below: with sections 751(a)(1) and 777(i)(1) of Cash Deposit Requirements the Act. Viraj The following deposit requirements Dated: May 17, 2004. • will be effective upon publication of The Department has revised the James J. Jochum, general and administrative and net this notice of final results of administrative review for all shipments Assistant Secretary for Import interest expense ratios based on the Administration. 2002–2003 financial statements. See of stainless steel wire rods from India Comment 5. entered, or withdrawn from warehouse, Appendix 1 for consumption on or after the date of • The Department has revised Viraj’s Issues in the Decision Memorandum publication, as provided by section brokerage and handling expenses as 751(a)(1) of the Act: (1) The cash deposit A. Issues with regard to Isibars partial adverse facts available due to rates for Viraj, Mukand, and Isibars will Viraj’s inability to substantiate these Comment 1: Facts Available be the rates shown above; (2) for expenses. See Comment 6. previously reviewed or investigated B. Issues with regard to Mukand • The Department has revised the U.S. companies not listed above, the cash Comment 2: Collapsing of Grades direct selling expenses to account for an deposit rate will continue to be the exchange rate conversion. See Comment company–specific rate published for the Comment 3: Agency Sales 8. most recent period; (3) if the exporter is Comment 4: Use of Partial Facts • The Department has revised Viraj’s not a firm covered in this review, a prior Available cost of production (‘‘COP’’) calculation review, or the original less–than-fair– C. Issues with regard to Viraj to account for rolling labor charges. See value (LTFV) investigation, but the Comment 9. manufacturer is, the cash deposit rate Comment 5: New Information • The Department has revised the will be the rate established for the most Comment 6: Brokerage and Handling calculation of home market imputed recent period for the manufacturer of Expenses credit expenses to account for sales the merchandise; and (4) if neither the Comment 7: Difference in Merchandise transactions with multiple pay dates. exporter nor the manufacturer is a firm Adjustment See Comment 12. covered in these or any previous reviews conducted by the Department, Comment 8: U.S. Direct Selling • The Department has revised the U.S. the cash deposit rate will be the ‘‘all Expenses credit rate used to calculate U.S. others’’ rate, which is 48.80 percent. Comment 9: Direct Labor imputed credit in accordance with These deposit requirements shall Comment 10: Net Interest Expenses Import Administration Policy Bulletin remain in effect until publication of the Comment 11: Home Market Credit 98–2. See Comment 13. final results of the next administrative Expense Final Results of Review review. Comment 12: Home Market Interest Rate We determine that the following Notification of Interested Parties Comment 13: U.S. Credit Expense percentage margins exist for the period This notice also serves as a final Comment 14: Duty Drawback December 1, 2001, through November reminder to importers of their [FR Doc. 04–11913 Filed 5–25–04; 8:45 am] 30, 2002: responsibility under 19 CFR BILLING CODE 3510–DS–S

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DEPARTMENT OF COMMERCE then serve as a bridge between users SUMMARY: The Department of (donor organizations) and experts to Commerce, as part of its continuing National Oceanic and Atmospheric help facilitate and coordinate the effort to reduce paperwork and Administration resulting collaboration. respondent burden, invites the general [I.D. 052104C] II. Method of Collection public and other Federal agencies to take this opportunity to comment on Proposed Information Collection; The information will be collected via proposed and/or continuing information Comment Request; NOAA Research an online web survey. collections, as required by the International Technical Assistance III. Data Paperwork Reduction Act of 1995, Program (ITAP) Public Law 104–13 (44 U.S.C. OMB Number: None. 3506(c)(2)(A)). AGENCY: National Oceanic and Form Number: None. Atmospheric Administration (NOAA). Type of Review: Regular submission. DATES: Written comments must be Affected Public: Federal Government, submitted on or before July 26, 2004. ACTION: Notice. State, Local or Tribal Government. ADDRESSES: Direct all written comments SUMMARY: The Department of Estimated Number of Respondents: to Diana Hynek, Departmental Commerce, as part of its continuing 1,500. Paperwork Clearance Officer, effort to reduce paperwork and Estimated Time Per Response: 20 Department of Commerce, Room 6625, respondent burden, invites the general minutes. 14th and Constitution Avenue, NW, public and other Federal agencies to Estimated Total Annual Burden Washington, DC 20230 (or via the take this opportunity to comment on Hours: 500 hours. Internet at [email protected]). Estimated Total Annual Cost to proposed and/or continuing information Public: $0. FOR FURTHER INFORMATION CONTACT: collections, as required by the Requests for additional information or Paperwork Reduction Act of 1995, IV. Request for Comments copies of the information collection Public Law 104–13 (44 U.S.C. Comments are invited on: (a) whether instrument and instructions should be 3506(c)(2)(A)). the proposed collection of information directed to Ruth Moore, N/MB3, DATES: Written comments must be is necessary for the proper performance SSMC4, Room 13108, 1305 East-West submitted on or before July 26, 2004. of the functions of the agency, including Highway, Silver Spring, MD 20910-3282 ADDRESSES: Direct all written comments whether the information shall have (phone 301–713–3050, ext. 169). to Diana Hynek, Departmental practical utility; (b) the accuracy of the SUPPLEMENTARY INFORMATION: agency’s estimate of the burden Paperwork Clearance Officer, I. Abstract Department of Commerce, Room 6625, (including hours and cost) of the 14th and Constitution Avenue, NW, proposed collection of information; (c) The Dr. Nancy Foster Scholarship Washington, DC 20230 (or via the ways to enhance the quality, utility, and Program recognizes outstanding Internet at [email protected]). clarity of the information to be scholarship by providing financial FOR FURTHER INFORMATION CONTACT: collected; and (d) ways to minimize the support to graduate students pursuing Requests for additional information or burden of the collection of information masters and doctoral degrees in the copies of the information collection on respondents, including through the areas of marine biology, oceanography, instrument and instructions should be use of automated collection techniques and maritime archaeology. The directed to Bruce Travis Creighton, 301– or other forms of information applicants must submit documentation 713–2469, ext. 124; email: technology. that NOAA uses to select candidates, [email protected]; or Jill Hepp, Comments submitted in response to including three letters of 301–713–2469, ext. 210; email: this notice will be summarized and/or recommendation. Persons receiving [email protected]. included in the request for OMB scholarships will be required to submit approval of this information collection; certain reports and other information SUPPLEMENTARY INFORMATION: they also will become a matter of public detailed below. record. I. Abstract II. Method of Collection Dated: May 19, 2004. The International Technical Respondents meet solicitation or Assistance Program (ITAP) for NOAA Gwellnar Banks, award requirements with paper Research is intended to stimulate the Management Analyst, Office of the Chief submissions. Electronic submissions are Information Officer. development of new collaborative being considered. Applicants submit relationships, foster exchanges of [FR Doc. 04–11909 Filed 5–25–04; 8:45 am] form CD-346 if they are chosen for the scientific personnel and information BILLING CODE 3510–KD–S program. between NOAA Research and other countries and secure outside resources III. Data to promote international research and DEPARTMENT OF COMMERCE OMB Number: 0648–0432. projects. To facilitate this, an online National Oceanic and Atmospheric Form Number: CD–346. survey has been developed. The survey Type of Review: Regular submission. Administration will act as a mechanism to catalog the Affected Public: Individuals or products, services, technical and [I.D. 052104E] households. language expertise of NOAA Research Estimated Number of Respondents: and its affiliated personnel. This Proposed Information Collection; 1,000. database will be used by NOAA Comment Request; Dr. Nancy Foster Estimated Time Per Response: 5 hours Research to enable potential users to Scholarship Program per application; 45 minutes for a letter link specific areas of expertise and AGENCY: National Oceanic and of recommendation; 15 minutes for an capabilities with funding for emerging Atmospheric Administration (NOAA). employment/non-employment international projects and initiatives. certification; 15 minutes for a Selective ACTION: Notice. NOAA Research and its partners will Service Statement from a male awardee;

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30 minutes for an academic progress SUMMARY: In a previously published Orleans, LA; Manteo, NC; San Juan, PR; report from the applicant; 30 minutes notice, NMFS announced the Destin, FL; Montauk, NY; Port Aransas, for an annual progress report from the availability of an issues and options TX; and Cocoa Beach, FL. Complete awardee’s school advisor; 30 minutes paper and the schedule of nine scoping schedule information of those public for an annual financial request; and 90 meetings to discuss the issues described scoping meetings along with minutes for a biography and photo from in the paper. In this notice, NMFS information pertaining to the issues and each awardee. announces one additional scoping options paper are contained in the April Estimated Total Annual Burden meeting and extends the comment 30, 2004, notice of availability and are Hours: 1,766. period on the issues and options paper. not repeated here. Estimated Total Annual Cost to Comments received on the issues and Public: $1,300. options paper and in the scoping Since the publication of the notice of availability, NMFS has scheduled one IV. Request for Comments meetings will assist NMFS in developing Amendment 2 to the HMS additional scoping meeting in Key West, Comments are invited on: (a) whether FMP and Amendment 2 to the Billfish FL, to allow interested parties an the proposed collection of information FMP. additional chance to comment on and is necessary for the proper performance DATES: The additional public scoping discuss the issues included in the issues of the functions of the agency, including meeting will be held on: Thursday, June and options paper. whether the information shall have 17, 2004, from 6:30 - 8:30 p.m. Additionally, to help ensure that all practical utility; (b) the accuracy of the The July 14, 2004, comment period on agency’s estimate of the burden interested parties have adequate time to the issues and options paper has been prepare their written comments, NMFS (including hours and cost) of the extended to July 23, 2004. proposed collection of information; (c) is extending the July 14, 2004, public ADDRESSES: The additional public ways to enhance the quality, utility, and comment period on the issues and scoping meeting will be held in: Pier clarity of the information to be options paper to July 23, 2004. House Hotel, 1 Duval Street, Key West, collected; and (d) ways to minimize the FL 33040. The public is reminded that NMFS burden of the collection of information Written comments on the issues and expects participants at the public on respondents, including through the options paper should be mailed to meetings to conduct themselves use of automated collection techniques Christopher Rogers, Chief, NMFS Highly appropriately. At the beginning of each or other forms of information Migratory Species Management public scoping meeting, an NMFS technology. Division, 1315 East-West Highway, representative will explain the ground Comments submitted in response to Silver Spring, MD 20910; or faxed to rules (e.g., alcohol is prohibited from this notice will be summarized and/or (301) 713–1917. Comments may also be the hearing room; attendees will be included in the request for OMB submitted by e-mail: called to give their comments in the approval of this information collection; [email protected]. order in which they registered to speak; they also will become a matter of public Copies of the issues and options paper record. each attendee will have an equal or the HMS and Billfish FMPs can be amount of time to speak; and attendees Dated: May 19, 2004. obtained from the HMS website at: should not interrupt one another). An Gwellnar Banks, http://www.nmfs.noaa.gov/sfa/hms, by NMFS representative will attempt to Management Analyst, Office of the Chief contacting Karyl Brewster-Geisz at (301) structure the meeting so that all Information Officer. 713–2347, or by writing to the address attendees will be able to comment, if [FR Doc. 04–11911 Filed 5–25–04; 8:45 am] above. they so choose, regardless of the BILLING CODE 3510–NK–S FOR FURTHER INFORMATION CONTACT: controversial nature of the subject(s). Karyl Brewster-Geisz at (301) 713–2347, Attendees are expected to respect the Mark Murray-Brown at (978) 281–9260, ground rules, and, if they do not, they DEPARTMENT OF COMMERCE or Russell Dunn at (727) 570–5447. will be asked to leave the meeting. SUPPLEMENTARY INFORMATION: Atlantic National Oceanic and Atmospheric tuna, swordfish, shark and billfish Special Accommodations Administration fisheries are managed under the [I.D. 060303D] authority of the Magnuson-Stevens These meetings are physically Fishery Conservation and Management accessible to people with disabilities. Atlantic Highly Migratory Species Act and regulated pursuant to the Requests for sign language (HMS); Issues and Options Paper for Atlantic Tunas Convention Act (ATCA), interpretation or other auxiliary aids Amendment 2 to the Fishery which authorizes the promulgation of should be directed to Heather Stirratt, Management Plan for Atlantic Tunas, rulemakings to implement (301) 713–2347, at least seven days prior Swordfish and Sharks (HMS FMP) and recommendations of the International to the meeting date. Amendment 2 to the Atlantic Billfish Convention for the Conservation of Authority: 16 U.S.C. 971 et seq. and 1801 Fishery Management Plan (Billfish Atlantic Tunas (ICCAT). Implementing et seq. FMP); Additional Public Scoping regulations for both the HMS FMP and Meeting and Extension of Comment the Billfish FMP are at 50 CFR part 635. Dated: May 20, 2004. Period On April 30, 2004 (69 FR 23730), NMFS Bruce C. Morehead, AGENCY: National Marine Fisheries published in the Federal Register a Acting Director, Office of Sustainable Service (NMFS), National Oceanic and notice of availability of an issues and Fisheries, National Marine Fisheries Service. Atmospheric Administration (NOAA), options paper that examines possible [FR Doc. 04–11912 Filed 5–25–04; 8:45 am] Commerce. alternatives for amending some of the BILLING CODE 3510–22–S regulations in the HMS and Billfish ACTION: Notice of additional public FMPs. That notice included the scoping meeting; extension of comment schedule for nine scoping meetings in period. Gloucester, MA; Ocean City, MD; New

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DEPARTMENT OF COMMERCE fax: (202) 501–6849; e-mail: direct investment in the Republic of [email protected]. Ireland. Exports from Ireland by U.S. Technology Administration subsidiaries over the past ten years have Commercial Setting for the Mission accounted for upwards of 30 percent of Undersecretarial Business The Republic of Ireland total Irish exports annually. Development Mission for Technology The ICT sector has been a key driver With 3.9 million people, a vibrant Industries to Northern Ireland and the to Ireland’s remarkable economic economy, and a young and highly Republic of Ireland October 17–22, growth over the past 15 years, and the educated workforce, the Republic of 2004 Irish government is endeavoring to Ireland represents an ideal market for ensure the sector will continue to play AGENCY: Technology Administration, U.S. companies seeking to find agents, an important role in maintaining strong U.S. Department of Commerce. distributors, and strategic partners for economic growth in the future. There is ACTION: Notice; request for applications business opportunities in the expanding also general recognition and by U.S. technology-based companies EU marketplace. For several years, the appreciation that U.S. foreign direct representing the information and Republic of Ireland has been the fastest- investment has helped stimulate the ICT communications technology (ICT) growing economy in the European sector. sector during this period of rapid Union. For the first time, after years of economic growth. double-digit growth fueled in part by a SUMMARY: Department of Commerce This maturing ICT sector with its rapidly expanding labor force, in 2002 technology-sector leaders will organize inherent expertise and acumen of Ireland experienced single-digit real a senior-level business development international business principles offers economic growth of 6.9 percent. Due mission to Belfast and Derry, Northern new and exciting opportunities for U.S. primarily to the appreciation of the Ireland (N.I.) and Dublin, Republic of ICT firms interested in the Irish and EU euro, growth in the Irish economy Ireland (R.O.I.). markets. Specifically, Ireland offers the The focus of the mission is to help dropped further in 2003 to 2.5 percent, prospect of strategic business U.S. companies explore business slightly below that of the U.S. and relationships between U.S. and Irish opportunities in both Northern Ireland Japan, but still keeping Ireland in the companies such as joint ventures, and the Republic of Ireland and the lead in Europe. Most economists believe licensing arrangements, technology newly expanded EU marketplace. The that a maturing Irish economy is well transfer agreements, agent/ delegation will include U.S. based poised to achieve stable annual growth distributorships, and logistics & valued senior executives representing the rates over the medium-term of 4 to 5 added services relationships. These information and communications percent. This is predicated on the Irish linkages allow U.S. companies to technology (ICT) sector. Technology investing significantly in infrastructure, capitalize on the skills and knowledge products and services have become an especially in transport, energy, and of Irish partners to access and penetrate increasingly important part of U.S. trade telecommunications. the Irish and European marketplaces A member of the European Union with Northern Ireland and the Republic more effectively and efficiently. (EU) since 1973, the Irish economic of Ireland, with both regions possessing model reflects an emphasis on open Northern Ireland highly skilled technology workers and markets, less government regulation, end users. Geographically, Northern Ireland is Therefore, emphasis will also be flexible labor markets, and fiscal the UK’s smallest region, being slightly placed on advancing market awareness, incentives to business (including low smaller than Connecticut. In recent development of strategic alliances in corporate taxes). As a small-island years, Northern Ireland has enjoyed one high-technology services and building economy, the Republic of Ireland is of the faster regional growth rates within networks that can further the dependent on international trade and the United Kingdom, all together it collaboration of business opportunities open access to overseas markets. With a accounts for about 2 percent of the UK in technology related markets. total trade surplus of approximately $24 economy. Economic growth has been billion in 2003, Ireland is a net fueled by the province’s knowledge DATES: Applications for the business exporting nation. International trade revolution, where the high tech sector development mission to Northern (imports and exports of goods and has benefited from significant support Ireland and the Republic of Ireland will services) totaled $238 billion in 2003— from the EU and the Northern Ireland be made available on or about June 1, the equivalent of 150 percent of GDP. In government in the form of direct 2004 (See Timeframe for Applications) 2003, merchandise exports from Ireland incentives and massive investment in and must be completed and received at were $93 billion—representing 60 education and R&D. The information the address below by no later than percent of Ireland’s Gross Domestic and communication technology market August 2, 2004. Product (GDP)—while merchandise is one of the fastest growing sectors in ADDRESSES: Please submit applications imports were some $54 billion. Northern Ireland and has been a driving to Nancy Hesser, Sector Manager, U.S. The U.S. and Ireland have strong and force behind the province enjoying the Commercial Service, U.S. Department of deepening economic and commercial fastest growth rate of any UK region. Commerce, 1401 Constitution Avenue, links. Total two-way merchandise trade The North has also benefited NW., Room 2119, Washington, DC is about $27 billion. The United States significantly from the dynamic ROI 20230. Applications may also be is Ireland’s second largest trading economy. With overall economic growth submitted via fax or e-mail to Nancy partner after the United Kingdom. The in the UK now expected to be in excess Hesser, Sector Manager at (202) 482– U.S. share of Ireland’s import market is of 3.5 percent in 2004, the province’s 2718 or e-mail around 15 percent, or $8 billion economy should continue to be strong. [email protected]. annually while approximately 15 Northern Ireland has gone through an FOR FURTHER INFORMATION CONTACT: Saul percent of total Irish exports annually industrial transformation with over 85 Summerall, International Office of are to the United States. With some $42 percent of the GDP now generated in the Technology Policy, Technology billion invested by 570 U.S. firms who services and high-tech manufacturing Administration, U.S. Department of employ over 90,000 people, the United sectors. More than 90 percent of jobs Commerce, telephone: (202) 482–6809; States is the largest source of foreign generated in recent years have been in

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the telecommunications, software, and Republic of Ireland markets, and the meetings, mission events, and information sectors. recently expanded EU marketplace. briefings in Dublin. The key investors in Northern Ireland • Highlighting market accessibility Friday, October 22—Departure. have been U.S. firms, having injected and successes of U.S. businesses in The precise schedule will depend in over $4 billion in the last few years. The these markets. part on the availability of local firms have responded to the fact that • Fostering dialog between policy government and business officials and Northern Ireland’s universities (Queens makers and academics in the technology the specific goals of the mission and University of Ulster) produce a arena of the U.S., Northern Ireland, and participants. higher percentage of IT qualified the Republic of Ireland. students than any other UK region. • Providing access to senior Criteria for Participation of Companies More than 13 percent of all students government officials and potential Eligibility graduate with engineering degrees in business partners for U.S. firms. Participating companies must be software, robotics, telecommunications, Scenario for the Mission incorporated in the United States. A digital signal processing, biomedical company is eligible to participate only and microelectronics. The Business Development Mission is if the products and/or services that it There are over 100 American a two and three day business program designed to provide participants with will promote (a) are manufactured or companies invested in Northern Ireland. produced in the United States; or (b) if These investors have created more than exposure to business, academic, and government contacts with an manufactured or produced outside the 4,000 new jobs in Northern Ireland. United States, are marketed under the Significant investors include Nortel understanding of market and technology trends and the commercial environment name of a U.S. firm and have U.S. Networks, Allstate, Skillsoft, Seagate content representing at least 51 percent Technology, Liberty Mutual, Raytheon, of Northern Ireland and the Republic of Ireland. of the value of the finished good or and Allen Systems Group. Software service. firms are buoyed by access to and Senior officials from two of the support from many research centers Department of Commerce’s leading Selection Criteria bureaus, charged with advancing the including the Northern Ireland Company participation will be interests of the technology and Knowledge Engineering Laboratory, the determined on the basis of: Digital Signal Processing and System- telecommunication sectors, will lead the • Relevance of the company’s on-Chip laboratories, and the Northern mission. The Technology business line to the mission scope and Ireland Center for e-Business. Administration (TA) and the National goals. Communications firms are supported by Telecommunications and Information • Potential for business activity in the Institute for Electronic Administration (NTIA) are well suited Northern Ireland and the Republic of Communications and Information to facilitate policy discussions with Ireland as applicable. Technology, the Advanced their Irish counterparts. • Level of seniority of the designated Telecommunications Laboratory, the Further, U.S. Embassy and Consulate company representatives and Center for Advanced Materials, the General officials will provide detailed consistency of company’s goals with the Semiconductor Research Center and the briefings on the economic, commercial scope and desired outcome of the Bio-Engineering Center. and political climates, and participants mission as described herein. Although the message from Northern will receive individual counseling on • Timely receipt of a completed Ireland is good, it must be understood their specific interests from U.S. application and participation agreement that Northern Ireland is not a significant Commercial Service industry signed by a company officer and the location for agents/distributors. Firms specialists. Meetings will be arranged as participation fee. located in either the Republic of Ireland appropriate with senior government • Provision of adequate information and Great Britain have historically decision makers, academic/technical on the company’s products and/or performed that function. While the institutions and relevant businesses. services, and communication of the small Northern Ireland population Representational events also will be company’s primary objectives to indicates there is only a minor market organized to provide mission facilitate appropriate matching with for U.S. sales, the provinces’ high-tech participants with opportunities to meet potential business partners. expertise offers abundant potential for senior business and government In addition, the Department may strategic alliances and other two-way representatives, as well as resident U.S. consider whether the company’s overall relationships; e.g., exchanging software, business people. business objectives, including those of contracting services and prospective The tentative trip itinerary will be as any U.S. or overseas affiliates, are fully business development opportunities. follows: consistent with the mission’s objectives. Sunday, October 17—Arrive Belfast, Goals for the Mission Any partisan political activities of an Northern Ireland, evening events applicant, including political The business development mission and briefing. contributions, will be entirely irrelevant will further both U.S. commercial policy Monday, October 18—One-on-One to the selection process. objectives and advance specific business Business Meetings in Belfast, Group interests. The mission is focused on: policy meetings. Time Frame for Applications • Introducing U.S. companies to the Tuesday, October 19—Business and Applications for the business Northern Ireland and Republic of Policy Meetings in Derry, Travel to development mission to Northern Ireland markets and furthering Dublin, Republic of Ireland. Ireland and the Republic of Ireland will commercial relationships. Wednesday, October 20—One-on-One be made available on or about June 1, • Assisting small and new-to-market Business Meetings; Group policy 2004. The fee to participate in the U.S. firms in evaluating the market meetings, mission events, and mission will be between $2,500.00 and potential for their products and to gain briefings in Dublin. $3,500.00 (depending on the size of the an understanding of how to operate Thursday, October 21—One-on-One business delegation) and will not cover successfully in the Northern Ireland and Business Meetings, Group policy travel or lodging expenses. For

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additional information on the business (TTY–TDD) may call (202) 565–2799 prevention effort. Using a ‘‘training the development mission or to obtain an between 8:30 a.m. and 5 p.m. eastern trainer’’ model, organizations will work application, respondents should refer to time, Monday through Friday. with volunteer coordinators to train and the contacts listed below. Completed DATES: Comments must be received on support volunteer parents of children applications should be submitted to the or before June 25, 2004. aged 18 or younger in providing drug address below by August 2, 2004 to ADDRESSES: Comments may be prevention training. ensure timely arrangements for in- submitted, identified by the title of the The specific aims of this evaluation country appointments for applicants information collection activity, by any selected to participate in the mission. are to describe the implementation of of the following two methods: the Parent Corps program Nancy Hesser, Sector Manager, U.S. (1) By fax to: (202) 395–6974, (implementation evaluation) and to Commercial Service, U.S. Attention: Ms. Katherine Astrich, OMB evaluate its impact on desired outcomes Department of Commerce, 1401 Desk Officer for the Corporation for Constitution Avenue, NW., Room (experimental impact evaluation). The National and Community Service; and implementation evaluation will include 2119, Washington, DC 20230. (2) Electronically by e-mail to: all 20 schools to be targeted by the Telephone (202) 482–4663, e-mail: [email protected]. [email protected]. Parent Corps. The randomized SUPPLEMENTARY INFORMATION: The OMB experiment impact evaluation will Applications may also be submitted is particularly interested in comments via fax to (202) 482–2718 by August 2, include parents and children at 18 which: schools (9 schools targeted by the Parent 2004. Applications received after that • Evaluate whether the proposed date will be considered only if space Corps and 9 control schools). These 18 collection of information is necessary treatment and control schools will be and scheduling constraints permit. for the proper performance of the The name, telephone number, and selected via the Parent Corps’ request functions of the Corporation, including address for the contact person for the for applications process. whether the information will have business development mission is: practical utility; Key research questions include Saul Summerall, International Office of • Evaluate the accuracy of the changes in the following outcomes: Technology Policy, Technology agency’s estimate of the burden of the perceived risk/harm from youth Administration, U.S. Department of proposed collection of information, substance use (tobacco, alcohol, or illicit Commerce, 1401 Constitution including the validity of the drug use), accuracy of perceptions about Avenue, NW., Room 4817, methodology and assumptions used; youth substance use, parents’ perceived Washington, DC 20230, Telephone: • Propose ways to enhance the susceptibility of their own youth to (202) 482–6809, Fax: (202) 501– quality, utility, and clarity of the substance use, parents’ self-efficacy to 6849, e-mail: information to be collected; and influence their youth’s substance use, [email protected]. • Propose ways to minimize the intervention activities among parents Dated: May 18, 2004. burden of the collection of information aware of their youth’s substance use, Benjamin Wu, on those who are to respond, including treatment-seeking for their youth’s Deputy Under Secretary for Technology. through the use of appropriate substance use, and parenting skills. In [FR Doc. 04–11929 Filed 5–25–04; 8:45 am] automated, electronic, mechanical, or addition, information will be collected other technological collection BILLING CODE 3510–GN–P from youths aged 12 to 18 living with techniques or other forms of information surveyed parents about involvement in technology, e.g., permitting electronic drug-free activities, their parents’ submissions of responses. CORPORATION FOR NATIONAL AND Type of Review: New. parenting skills, parent-child COMMUNITY SERVICE Agency: Corporation for National and communication, perceived risk/harm from youth substance use, accuracy of New Information Collection; Community Service. Title: Parent Corps Evaluation. perceptions about youth substance use, Submission for OMB Review; association with drug-using peers, Comment Request OMB Number: None. Agency Number: None. perceived susceptibility to substance AGENCY: Corporation for National and Affected Public: Individuals and use and intentions to use substances, Community Service. households. substance use, exposure to prevention ACTION: Notice. Total Respondents: 3,700. program activities, and demographic Frequency: Annually. characteristics. Implementation SUMMARY: The Corporation for National Average Time per Response: 15 evaluation data will be collected and Community Service (hereinafter the minutes. primarily through questionnaires mailed ‘‘Corporation’’), has submitted a Estimated Total Burden Hours: 1,654 to parent leaders and parent volunteers proposed new public information hours. delivering the program, and impact collection request (ICR) entitled Parent Total Burden Cost (capital/startup): evaluation data will be collected via Corps Evaluation to the Office of None. computer-assisted telephone interview Management and Budget (OMB) for Total Burden Cost (operating/ (CATI) with parents and their children review and approval in accordance with maintenance): None. the Paperwork Reduction Act of 1995 aged 12 to 18 who attend treatment or (Pub. L. 104–13), (44 U.S.C. chapter 35). Description control schools. Copies of this ICR, with applicable Parent Corps Evaluation: The Dated: May 19, 2004. supporting documentation, may be Corporation proposes to conduct an David Reingold, obtained by calling the Corporation for evaluation of the Parent Corps program. Director, Research and Policy Development. National and Community Service, Kelly The Parent Corps is a three-year effort [FR Doc. 04–11868 Filed 5–25–04; 8:45 am] Arey, (202) 606–5000, ext. 197. to create a national training system and Individuals who use a network of volunteer parents engaged in BILLING CODE 6050–$$–P telecommunications device for the deaf a nationwide substance abuse

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DEPARTMENT OF DEFENSE controls, and maintains 1.1 million would continue according to current acres of fully instrumented land ranges. patterns of use. The implementation of Department of the Navy Continued use of these land ranges the CLUMP and INRMP would provide requires compliance with the California for the sound management of land use Record of Decision for Proposed Desert Protection Act of 1994 and the and environmental resources to Future Military Operational Increases Sikes Act, as amended in 1997. accommodate future limited operational and Implementation of Associated Implementation of the CLUMP and the increases. Comprehensive Land Use Management INRMP will enable NAWS China Lake Under the No Action Alternative, Plan and Integrated Natural Resources to beneficially manage environmental, existing operating conditions at NAWS Management Plan, China Lake, CA land, and cultural resources such that China Lake would be maintained at there is no net loss in the capability of current levels as set forth in the Final AGENCY: Department of the Navy, DOD. the installation to support its existing EIS. Nonmilitary activities would ACTION: Notice of record of decision. military mission. These plans will also continue according to current patterns facilitate environmentally sound of use. As required by law, the CLUMP SUMMARY: The Department of the Navy resource management decisions when and INRMP would be implemented announces its decision to support future responding to planned increases in and under this alternative to provide for the military operational increases and emerging military readiness needs. management of land use and implementation of the associated Alternatives Considered: A screening environmental resources to Comprehensive Land Use Management process, based upon criteria set out in accommodate the type, tempo, and Plan (CLUMP) and Integrated Natural the Final EIS, was conducted to identify location of military T&E and training Resources Management Plan (INRMP) at a reasonable range of alternatives that operations currently conducted at Naval Air Weapons Station (NAWS) would satisfy the Navy’s purpose and NAWS China Lake. The No Action China Lake, CA. need. Two operational alternatives and Alternative is the environmentally FOR FURTHER INFORMATION CONTACT: the no action alternative were analyzed preferred alternative because it involves Commander, NAWS-Code N45NCW, in detail in the Final EIS. the least amount of change to the 429 East Bowen Road, MS 4014, China The preferred alternative is the physical environment. Lake, CA 93555–6108 (Attn: Mr. John Moderate Expansion Alternative, which Environmental Impacts: Potential O’Gara); phone (760) 939–3213; provides NAWS China Lake with the environmental impacts associated with facsimile (760) 939–2980; or E-Mail: greatest flexibility to accommodate the three alternatives were analyzed in [email protected]. evolving Navy and DOD Test and the Final EIS. Because on-going and Evaluation (T&E) and operational future operational increases will SUPPLEMENTARY INFORMATION: Pursuant readiness needs. This alternative continue to occur in range areas that to Section 102(2)(c) of the National involves phasing future military have been previously disturbed Environmental Policy Act (NEPA) of operational increases over a five-year (including those areas that may have 1969 (42 U.S.C. § 4321 et seq.); Council period, according to operational needs. been underutilized in the recent past), on Environmental Quality (CEQ) These operational increases would and the objectives of the CLUMP and regulations (40 CFR Parts 1500–1508); include: a 25-percent increase over the INRMP are to institute land use and and Department of the Navy regulations type and tempo of current range flight environmental management practices (32 CFR 775), the Department of the operations, airfield flight operations, that minimize the potential for adverse Navy (Navy) announces its decision to range ground operations; and, an effects, no significant environmental support future military operational increase in range supersonic flights from impacts were identified to any of the increases and implementation of the 36 to 100 operations per year. An resource areas. Consequently, no associated CLUMP and INRMP at increase in ground troop training mitigation measures are proposed. NAWS China Lake, CA. This will be exercises from 22 to 42 events per year The CLUMP will be implemented in accomplished as set out in the Moderate is also proposed. Nonmilitary activities accordance with the 1994 Memorandum Expansion Alternative as described in would continue according to current of Agreement between the Secretary of the Final Environmental Impact patterns of use. The implementation of the Interior and the Secretary of the Statement (EIS). This decision will the CLUMP and INRMP would provide Navy regarding the management of enable the Navy to meet its established for the sound management of land use withdrawn lands at NAWS China Lake. mission to support state-of-the-art air and environmental resources to Implementation of the CLUMP and warfare weapons systems testing and accommodate future moderate INRMP will result in beneficial impacts evaluation and the operational readiness operational increases. at NAWS by standardizing baseline data of the military services on both existing The Limited Expansion Alternative for land use patterns and environmental facilities and infrastructure and safe, also provides for a five-year phase-in of resources using electronic mapping operationally realistic, and thoroughly increased military operations at NAWS technology (Geographic Information instrumented land ranges. China Lake, in accordance with Systems), and formalizing and Background and Issues: As the Navy’s operational needs. However, military integrating the station’s environmental full-spectrum Research, Development, operational increases would be less than review process with facility, Test, and Evaluation (RDT&E) center for those proposed under the Moderate infrastructure, and operational planning weapons systems associated with air Expansion Alternative, and would processes. CLUMP implementation will warfare, aircraft weapons integration, include: a 15-percent increase over the facilitate the environmental reviews of missiles and missile subsystems, and type and tempo of current range flight on-going and proposed military test and assigned airborne electronic warfare operations, airfield flight operations, training activities, potential facilities systems, NAWS China Lake is host to range ground operations; and, an construction, operation and the Naval Air Warfare Center Weapons increase in range supersonic flights from maintenance efforts and related support Division (NAWCWD) and other DOD 36 to 100 operations per year. An activities, and nonmilitary uses. activities. To support NAWCWD’s increase in ground troop training Information regarding other Federal RDT&E mission and military readiness exercises from 22 to 41 events per year regulatory processes associated with training, NAWS China Lake schedules, is also proposed. Nonmilitary activities this action is presented below.

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The Navy initiated formal raised in comment letters were would defeat the purpose of the consultation under Section 7 of the thoroughly analyzed and discussed in information collection, violate State or Endangered Species Act with the U.S. the Final EIS. Federal law, or substantially interfere Fish and Wildlife Service (USFWS) in Conclusions: After carefully with any agency’s ability to perform its 1990, 1995, and 1997, respectively, for considering the purpose and need for statutory obligations. The Leader, each of the three protected wildlife the proposed action, the analyses Regulatory Information Management species occurring at China Lake: the contained in the Final EIS, and the Group, Office of the Chief Information Inyo California towhee, the desert comments received on the Draft and Officer, publishes that notice containing tortoise, and the Mojave tui chub. The Final EIS from Federal, state, and local proposed information collection USFWS issued Biological Opinions agencies, non-governmental requests prior to submission of these (BOs) for the three species that cover a organizations, and individual members requests to OMB. Each proposed range of actions from habitat of the public, I have determined that the information collection, grouped by maintenance and enhancement, to a preferred alternative, the Moderate office, contains the following: (1) Type programmatic BO for the desert tortoise Expansion Alternative, will best meet of review requested, e.g., new, revision, encompassing established military the needs of the Navy. extension, existing or reinstatement; (2) operations conducted in tortoise habitat Implementation of the Moderate Title; (3) Summary of the collection; (4) on NAWS. The Navy has determined Expansion Alternative will enhance the Description of the need for, and that the preferred alternative is existing assets and capabilities of proposed use of, the information; (5) consistent with the terms and NAWS China Lake; provide for meeting Respondents and frequency of conditions of the existing BOs and current and evolving Navy and DOD collection; and (6) Reporting and/or would not adversely affect Federally operational, testing, and training Recordkeeping burden. OMB invites listed species. USFWS has confirmed requirements; and achieve Navy public comment. this conclusion through informal compliance with the California Desert Dated: May 20, 2004. consultation with NAWS throughout the Protection Act of 1994 and the Sikes Angela C. Arrington, NEPA process. Act, as amended in 1997. NAWS China Lake employs a phased Leader, Regulatory Information Management Dated: May 19, 2004. Group, Office of the Chief Information Officer. approach to compliance with Section 106 of the National Historic Donald R. Schregardus, Office of Special Education and Preservation Act (NHPA) (16 U.S.C. Deputy Assistant Secretary of the Navy Rehabilitative Services 470). The California State Historic (Environment). [FR Doc. 04–11906 Filed 5–25–04; 8:45 am] Type of Review: Extension. Preservation Officer (SHPO) has Title: Assurances for the Protection concurred that the NAWS approach is BILLING CODE 3810–FF–P and Advocacy for Assistive Technology consistent with NHPA regulations. In (PAAT) Program. addition, a draft Programmatic Frequency: Periodically. Agreement (PA) has been developed to DEPARTMENT OF EDUCATION Affected Public: Not-for-profit facilitate the protection of cultural institutions; State, local, or tribal gov’t, Submission for OMB Review; resources. This PA will be finalized SEAs or LEAs. through formal consultation in Comment Request Reporting and Recordkeeping Hour accordance with comments received AGENCY: Department of Education. Burden: from the California SHPO and area SUMMARY: The Leader, Regulatory Responses: 1. Burden Hours: 9. Tribes. NAWS China Lake will continue Information Management Group, Office to implement appropriate management Abstract: This document will be used of the Chief Information Officer invites by grantees to request funds to carry out plans and procedures to ensure comments on the submission for OMB compliance with the NHPA, and to the PAAT program. PAAT is mandated review as required by the Paperwork by the Assistive Technology Act of consult and coordinate (as appropriate) Reduction Act of 1995. with the California SHPO and area 1998, to provide protection and DATES: Interested persons are invited to Tribes. advocacy services to individuals with Response To Comments Received submit comments on or before June 25, disabilities for the purposes of assisting Regarding the Final EIS: The Final EIS 2004. in the acquisition, utilization, or was distributed to government agencies ADDRESSES: Written comments should maintenance of assistive technology or and the public on March 05, 2004, for be addressed to the Office of assistive technology services. a 30-day public review period. During Information and Regulatory Affairs, Requests for copies of the submission this period only two comment letters Attention: Alice Thaler, Desk Officer, for OMB review; comment request may were received, both from private Department of Education, Office of be accessed from http:// landowners in the vicinity of NAWS Management and Budget, 725 17th edicsweb.ed.gov, by selecting the China Lake. The comments identified Street, NW., Room 10222, New ‘‘Browse Pending Collections’’ link and concerns related to air quality, range Executive Office Building, Washington, by clicking on link number 2471. When safety, potential seismic events, off- DC 20503 or faxed to (202) 395–6974. you access the information collection, station land uses, access to station SUPPLEMENTARY INFORMATION: Section click on ‘‘Download Attachments’’ to property, airspace management, and 3506 of the Paperwork Reduction Act of view. Written requests for information aircraft operations. Some of the 1995 (44 U.S.C. chapter 35) requires that should be addressed to Department of comments are not related to the the Office of Management and Budget Education, 400 Maryland Avenue, SW., proposed action or the Final EIS and (OMB) provide interested Federal Potomac Center, 9th Floor, Washington, would be more appropriately directed agencies and the public an early DC 20202–4700. Requests may also be toward local civil authorities or the opportunity to comment on information electronically mailed to the Internet NAWS China Lake Public Affairs Office. collection requests. OMB may amend or address [email protected] or faxed to No new substantive issues concerning waive the requirement for public 202–245–6623. Please specify the the proposed action were raised in the consultation to the extent that public complete title of the information comments received. All of the issues participation in the approval process collection when making your request.

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Comments regarding burden and/or of burden accurate; (4) how might the Relay Service (FIRS) at 1–800–877– the collection activity requirements Department enhance the quality, utility, 8339. should be directed to Sheila Carey at her and clarity of the information to be [FR Doc. 04–11867 Filed 5–25–04; 8:45 am] e-mail address Sheila [email protected]. collected; and (5) how might the BILLING CODE 4000–01–P Individuals who use a Department minimize the burden of this telecommunications device for the deaf collection on the respondents, including (TDD) may call the Federal Information through the use of information Relay Service (FIRS) at 1–800–877– technology. DEPARTMENT OF ENERGY 8339. Dated: May 20, 2004. [Docket Nos. EA–261–A and EA–263–A] [FR Doc. 04–11866 Filed 5–25–04; 8:45 am] Angela C. Arrington, Applications To Export Electric BILLING CODE 4000–01–P Leader, Regulatory Information Management Energy; UBS AG, London Branch Group, Office of the Chief Information Officer. AGENCY: Institute of Education Sciences Office of Fossil Energy, DOE. DEPARTMENT OF EDUCATION ACTION: Notice of applications. Type of Review: New. Notice of Proposed Information SUMMARY: Under separate applications, Collection Requests Title: The Professional Development Impact Study—Participating District UBS AG, London Branch (UBS) has AGENCY: Department of Education. and School Screening Protocols. applied to renew its authority to transmit electric energy from the United SUMMARY: The Leader, Regulatory Frequency: One time. States to Mexico and from the United Information Management Group, Office Affected Public: Not-for-profit States to Canada pursuant to section of the Chief Information Officer, invites institutions (primary). 202(e) of the Federal Power Act. comments on the proposed information Reporting and Recordkeeping Hour DATES: Comments, protests or requests collection requests as required by the Burden: Paperwork Reduction Act of 1995. to intervene must be submitted on or Responses: 179. before June 25, 2004. DATES: Interested persons are invited to submit comments on or before July 26, Burden Hours: 179. ADDRESSES: Comments, protests or 2004. Abstract: The current OMB package requests to intervene should be addressed as follows: Office of Coal & SUPPLEMENTARY INFORMATION: Section requests clearance for the instruments to 3506 of the Paperwork Reduction Act of be used in screening districts and Power Import/Export (FE–27), Office of 1995 (44 U.S.C. chapter 35) requires that schools for eligibility to participate in Fossil Energy, U.S. Department of the Office of Management and Budget the Professional Development Impact Energy, 1000 Independence Avenue, (OMB) provide interested Federal Study. To be eligible for the full study, SW., Washington, DC 20585–0350 (FAX agencies and the public an early districts and schools must meet a list of 202–287–5736). opportunity to comment on information criteria that are designed to ensure that FOR FURTHER INFORMATION CONTACT: collection requests. OMB may amend or the study sample is relevant to the Steven Mintz (Program Office) 202–586– waive the requirement for public purposes of the study (e.g., are 9506 or Michael Skinker (Program consultation to the extent that public implementing one of two scientifically Attorney) 202–586–2793. participation in the approval process based reading programs of interest in SUPPLEMENTARY INFORMATION: Exports of would defeat the purpose of the the study) and are relevant to current electricity from the United States to a information collection, violate State or legislation such as the NCLB Act (e.g., foreign country are regulated and Federal law, or substantially interfere districts and schools serve high poverty require authorization under section with any agency’s ability to perform its students). 202(e) of the Federal Power Act (FPA) statutory obligations. The Leader, Requests for copies of the proposed (16 U.S.C. § 824a(e)). Regulatory Information Management information collection request may be On June 3, 2002, the Office of Fossil Group, Office of the Chief Information accessed from http://edicsweb.ed.gov, Energy (FE) of the Department of Energy Officer, publishes that notice containing by selecting the ‘‘Browse Pending (DOE) issued Order No. EA–261 proposed information collection Collections’’ link and by clicking on authorizing UBS to transmit electric requests prior to submission of these link number 2557. When you access the energy from the United States to Mexico requests to OMB. Each proposed information collection, click on as a power marketer using existing information collection, grouped by ‘‘Download Attachments’’ to view. international electric transmission office, contains the following: (1) Type Written requests for information should facilities. That two-year authorization of review requested, e.g., new, revision, be addressed to Department of will expire on June 3, 2004. On June 4, extension, existing or reinstatement; (2) Education, 400 Maryland Avenue, SW., 2002, FE issued Order No. EA–263 Title; (3) Summary of the collection; (4) Potomac Center, 9th Floor, Washington, authorizing UBS to transmit electric Description of the need for, and DC 20202–4700. Requests may also be energy from the United States to Canada proposed use of, the information; (5) electronically mailed to the Internet as a power marketer using existing Respondents and frequency of address [email protected] or faxed to international electric transmission collection; and (6) Reporting and/or 202–245–6623. Please specify the facilities. That two-year authorization Recordkeeping burden. OMB invites complete title of the information will expire on June 4, 2004. public comment. collection when making your request. On April 30, 2004, the FE received The Department of Education is Comments regarding burden and/or applications from UBS to renew its especially interested in public comment the collection activity requirements authorizations to transmit electric addressing the following issues: (1) Is should be directed to Kathy Axt at her energy from the United States to Mexico this collection necessary to the proper e-mail address Kathy [email protected]. and from the United States to Canada functions of the Department; (2) will Individuals who use a for terms of five years. UBS, a Swiss this information be processed and used telecommunications device for the deaf corporation formed in 1998 by the in a timely manner; (3) is the estimate (TDD) may call the Federal Information merger of Union Bank of Switzerland

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and Swiss Bank Corporation, is a power provided above or by accessing the through one of the means provided marketer that does not own or control Fossil Energy Home Page at http:// above. The Draft EIS is also available at any electric generation or transmission www.fe.doe.gov. Upon reaching the the offices of the Bureau of Land facilities nor does it have any franchised Fossil Energy Home page, select Management, 1661 South Fourth Street, service territory in the United States. ‘‘Electricity Regulation,’’ and then El Centro, CA 92243, (telephone 760– In FE Docket No. EA–261–A, UBS ‘‘Pending Proceedings’’ from the options 337–4400), and on the Internet at http: proposes to export electric energy to menus. //web.ead.anl.gov/bajatermoeis and Mexico and to arrange for the delivery Issued in Washington, DC, on May 20, http://www.eh.doe.gov/nepa, under of those exports to Mexico over the 2004. ‘‘What’s New.’’ international transmission facilities Anthony J. Como, owned by San Diego Gas and Electric SUPPLEMENTARY INFORMATION: Company, El Paso Electric Company, Deputy Director, Electric Power Regulation, Office of Coal & Power Import/Export, Office The Draft EIS evaluates the Central Power and Light Company, and of Coal & Power Systems, Office of Fossil environmental impacts of DOE’s Comision Federal de Electricidad (CFE), Energy. proposed Federal actions of issuing the national electric utility of Mexico. [FR Doc. 04–11905 Filed 5–25–04; 8:45 am] In FE Docket No. EA–263–A, UBS Presidential permits to either Baja proposes to export electric energy to BILLING CODE 6450–01–P California Power, Inc. or Sempra Energy Canada and to arrange for the delivery Resources (also known as Intergen and Sempra, respectively), or to both, for the of those exports over the international DEPARTMENT OF ENERGY transmission facilities owned by Basin construction, operation, maintenance, Electric Power Cooperative, Bonneville [FE Docket Nos. PP–234 & PP–235] and connection of two double-circuit, Power Administration, Eastern Maine 230,000-volt electric transmission lines Electric Cooperative, International Notice Extending Comment Period and that would cross the United States Transmission Company, Joint Owners of Rescheduling Public Hearings on the international border in the vicinity of the Highgate Project, Long Sault, Inc., Draft EIS for the Imperial-Mexicali 230- Calexico, California, and connect to Maine Electric Power Company, Maine kV Transmission Lines; Baja California separate natural gas-fired electric power Public Service Company, Minnesota Power, Inc. and Sempra Energy plants that have been constructed in Power, Inc., Minnkota Power Resources Mexico. BLM’s proposed Federal Cooperative, New York Power AGENCY: Department of Energy (DOE). actions are the issuance of right-of-way Authority, Niagara Mohawk Power ACTION: Notice of hearings. grants to allow the transmission lines to Corporation, Northern States Power, and cross Federal lands within BLM’s Vermont Electric Transmission SUMMARY: The Department of Energy management responsibility. Company. (DOE), with the Department of the On May 11, 2004, DOE published a The construction of each of the Interior’s Bureau of Land Management international transmission facilities to (BLM) as a cooperating agency, notice in the Federal Register (69 FR be utilized by UBS, as more fully announces the extension of the public 26089) announcing the availability of described in the applications, has comment period for the ‘‘Imperial- the Draft EIS and a schedule for public previously been authorized by a Mexicali 230-kV Transmission Lines hearings. The Environmental Protection Presidential permit issued pursuant to Draft Environmental Impact Statement’’ Agency published its notice of Executive Order 10485, as amended. (DOE/EIS–0365). In addition, the public availability of the Draft EIS (EPA Procedural Matters: Any person hearings to receive comments on the Document No. 040222) on May 14, 2004 desiring to become a party to these Draft EIS, originally scheduled for June (69 FR 26817) that began a 45-day proceedings or to be heard by filing 17, 2004, have been rescheduled for July comment period which was to end on comments or protests to these 14, 2004. June 30, 2004. However, at the request applications should file a petition to DATES: The comment period on the Draft of the Border Power Plant Working intervene, comment or protest at the EIS is extended until July 30, 2004. Group, DOE is extending the comment address provided above in accordance Dates for the public hearings are: period until July 30, 2004. In addition, with §§ 385.211 or 385.214 of the the public hearings originally scheduled FERC’s Rules of Practice and Procedures 1. July 14, 2004, 11 a.m. to 1 p.m., El for June 17, 2004, have been (18 CFR 385.211, 385.214). Fifteen Centro, California. 2. July 14, 2004, 6 p.m. to 8 p.m., rescheduled to July 14, 2004. Further copies of each petition and protest Calexico, California. should be filed with the DOE on or information on this proceeding is before the dates listed above. ADDRESSES: Requests to speak at the contained in the DOE Notice of Comments on the UBS applications to public hearings should be addressed to: Availability previously referenced. export electric energy to Mexico and/or Mrs. Ellen Russell, Office of Fossil Issued in Washington, DC, on May 20, Canada should be clearly marked with Energy (FE–27), U.S. Department of 2004. Energy, Washington, DC 20585, or Docket EA–261–A and/or Docket EA– Anthony J. Como, 263–A, respectively. Additional copies transmitted by phone: 202–586–9624, Deputy Director, Electric Power Regulation, are to be filed directly with Andrea M. by facsimile: 202–287–5736, or by electronic mail at Office of Coal & Power Import/Export, Office Settanni, Bracewell & Patterson, L.L.P., of Coal & Power Systems, Office of Fossil 2000 K Street, NW., Suite 500, [email protected]. The locations of the public hearings Energy. Washington, DC 20006–1872 AND [FR Doc. 04–11904 Filed 5–25–04; 8:45 am] Suzanne Calcagno, Director, Regulatory are: Compliance, UBS Energy LLC, 677 1. El Centro City Hall, 1275 W. Main BILLING CODE 6450–01–P Washington Blvd., 8th Floor, Stamford, Street, El Centro, California. CT 06901. 2. Calexico City Hall, 608 Heber Street, Copies of these applications will be Calexico, California. made available, upon request, for public Printed copies of the Draft EIS may be inspection and copying at the address obtained by contacting Mrs. Russell

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DEPARTMENT OF ENERGY DEPARTMENT OF ENERGY proceeding can ask for court review of Commission orders in the proceeding. Federal Energy Regulatory Federal Energy Regulatory However, a person does not have to Commission Commission intervene in order to have comments [Docket No. CP04–336–000] considered. The second way to [Docket No. ER04–808–000] participate is by filing with the Dominion Transmission, Inc.; Notice of Secretary of the Commission, as soon as Ameren Services Company; Notice of Application possible, an original and two copies of Filing comments in support of or in opposition May 19, 2004. to this project. The Commission will May 11, 2004. Take notice that on May 13, 2004, consider these comments in Dominion Transmission, Inc. (DTI), Take notice that on May 3, 2004, determining the appropriate action to be Ameren Services Company (ASC) having its principal place of business at 120 Tredegar Street, Richmond, Virginia taken, but the filing of a comment alone tendered for filing an executed Network will not serve to make the filer a party Integration Transmission Service and a 23219, filed a prior notice request pursuant to 18 CFR 157.205 and 157.208 to the proceeding. The Commission’s Network Operating Agreement between rules require that persons filing ASC and EnerStar Power Corp. ASC of the Commission’s regulations under the Natural Gas Act, and DTI’s comments in opposition to the project requests an effective date of April 1, provide copies of their protests only to 2004. authorization in Docket CP82–537–000, 21 FERC ¶ 62,171 (1982), to reroute a the party or parties directly involved in Any person desiring to intervene or to 3,000-foot segment of its existing the protest. protest this filing should file with the transmission pipeline designated as TL– Persons who wish to comment only Federal Energy Regulatory Commission, 263, and to replace in total on the environmental review of this ″ 888 First Street, NE., Washington, DC approximately eight miles of 12 pipe project should submit an original and 20426, in accordance with rules 211 and between Wyoming, WV and Cheylan, two copies of their comments to the 214 of the Commission’s rules of WV. DTI states that the project is Secretary of the Commission. practice and procedure (18 CFR 385.211 necessary due to deteriorated segments Environmental commenters will be and 385.214). Protests will be of pipeline that have been identified placed on the Commission’s considered by the Commission in through field testing. This filing may be environmental mailing list, will receive viewed on the Web at http:// determining the appropriate action to be copies of the environmental documents, www.ferc.gov using the ‘‘eLibrary’’ link. taken, but will not serve to make and will be notified of meetings protestants parties to the proceeding. Enter the docket number excluding the last three digits in the docket number associated with the Commission’s Any person wishing to become a party environmental review process. must file a motion to intervene. All such field to access the document. For assistance, contact FERC Online Environmental commenters will not be motions or protests should be filed on required to serve copies of filed or before the comment date, and, to the Support at [email protected] or toll- documents on all other parties. extent applicable, must be served on the However, the non-party commenters applicant and on any other person free at (866) 208–3676, or for TTY, contact (202) 502–8659. will not receive copies of all documents designated on the official service list. filed by other parties or issued by the This filing is available for review at the Any questions regarding this request should be directed to Lorraine Cote, Commission (except for mailing of Commission or may be viewed on the Dominion Transmission, Inc. 120 environmental documents issued by the Commission’s Web site at http:// Tredegar Street, Richmond, VA 23219 Commission) and will not have the right www.ferc.gov, using the eLibrary (toll-free) 866–319–3382. to seek court review of the (FERRIS) link. Enter the docket number There are two ways to become Commission’s final order. excluding the last three digits in the involved in the Commission’s review of Comments, protests and interventions docket number field to access the this project. First, any person wishing to document. For assistance, please contact may be filed electronically via the obtain legal status by becoming a party Internet in lieu of paper. The FERC Online Support at to the proceedings for this project Commission strongly encourages [email protected] or toll- should, on or before the comment date electronic filings. See 18 CFR free at (866) 208–3676, or for TTY, stated below file with the Federal contact (202) 502–8659. Protests and Energy Regulatory Commission, 888 385.2001(a)(1)(iii) and instructions on interventions may be filed electronically First Street, NE., Washington, DC 20426, the Commission’s Web site under the via the Internet in lieu of paper; see 18 a motion to intervene or a protest in ‘‘e-Filing’’ link. CFR 385.2001(a)(1)(iii) and the accordance with the requirements of the Comment Date: June 9, 2004. instructions on the Commission’s Web Commission’s rules of practice and Magalie R. Salas, site under the ‘‘e-Filing’’ link. The procedure (18 CFR 385.214 or 385.211) Commission strongly encourages and the regulations under the NGA (18 Secretary. electronic filings. CFR 157.10). A person obtaining party [FR Doc. E4–1211 Filed 5–25–04; 8:45 am] status will be placed on the service list BILLING CODE 6717–01–P Comment Date: May 24, 2004. maintained by the Secretary of the Linda Mitry, Commission and will receive copies of Acting Secretary. all documents filed by the applicant and [FR Doc. E4–1212 Filed 5–25–04; 8:45 am] by all other parties. A party must submit 14 copies of filings made with the BILLING CODE 6717–01–P Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the

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DEPARTMENT OF ENERGY DEPARTMENT OF ENERGY Questar maintains that the estimated project cost would be $13.5 million. Federal Energy Regulatory Federal Energy Regulatory Any person or the Commission’s Staff Commission Commission may, within 45 days after the issuance [Docket No. CP04–335–000] of the instant notice by the Commission, [Docket No. RP04–179–003] file pursuant to rule 214 of the Questar Pipeline Company; Notice of Commission’s procedural rules (18 CFR National Fuel Gas Supply Corporation; Request Under Blanket Authorization 385.214) a motion to intervene or notice Notice of Compliance Filing of intervention and, pursuant to section May 19, 2004. 157.205 of the Commission’s regulations May 19, 2004. Take notice that on May 11, 2004, under the Natural Gas Act (NGA) (18 Questar Pipeline Company (Questar), CFR 157.205) a protest to the request. If Take notice that on May 13, 2004, 180 East 100 South, Salt Lake City, Utah National Fuel Gas Supply Corporation no protest is filed within the time 84111, filed in Docket No. CP04–335– allowed therefore, the proposed activity (National Fuel) tendered for filing as 000 a request pursuant to sections part of its FERC Gas Tariff, Fourth shall be deemed to be authorized 157.208(b) and 157.211 of the effective the day after the time allowed Revised Volume No. 1, Fifth Revised Commission’s Regulations under the for protest. If a protest is filed and not Sheet No. 478, to become effective July Natural Gas Act (18 CFR 157.205 and withdrawn within 30 days after the time 1, 2004. 157.208) for authorization to construct allowed for filing a protest, the instant National Fuel states that the instant and operate a 13.4 mile, 20-inch request shall be treated as an filing is being made in compliance with diameter delivery lateral, a application for authorization pursuant the letter order issued by the measurement and control station and to section 7 of the NGA. Commission on March 31, 2004, in appurtenances in Utah and Juab Comments, protests and interventions Docket No. RP04–179–000. National Counties, Utah, under the authorization may be filed electronically via the issued in Docket No. CP82–491–000 Fuel states that in compliance with that Internet in lieu of paper. See 18 CFR pursuant to section 7 of the Natural Gas 385.2001(a)(1)(iii) and the instructions directive, it submits Fifth Revised Sheet Act, all as more fully described in the No. 478 and a red-lined copy of Service on the Commission’s Web site under the request. ‘‘e-Filing’’ link. Agreement No. F10706. Questar states that copies of this National Fuel states that copies of this request are on file with the Commission Magalie R. Salas, filing were served upon its customers and are available for public inspection. Secretary. and interested State commissions. This filing may also be viewed on the [FR Doc. E4–1210 Filed 5–25–04; 8:45 am] web at http://www.ferc.gov using the Any person desiring to protest said BILLING CODE 6717–01–P ‘‘eLibrary’’ link. Enter the docket filing should file a protest with the number excluding the last three digits in Federal Energy Regulatory Commission, the docket number field to access the DEPARTMENT OF ENERGY 888 First Street, NE., Washington, DC document. For assistance, please contact 20426, in accordance with § 385.211 of FERC Online Support at Federal Energy Regulatory the Commission’s rules and regulations. [email protected] or toll- Commission All such protests must be filed in free at (866) 208–3676, or for TTY, [Docket No. RP96–312–138] accordance with § 154.210 of the contact (202) 502–8659. Commission’s regulations. Protests will Any questions concerning this request Tennessee Gas Pipeline Company; be considered by the Commission in may be directed to Lenard G. Wright, Notice of Negotiated Rates determining the appropriate action to be Director of Federal Regulation, Questar taken, but will not serve to make Pipeline Company, 180 East 100 South, May 19, 2004. protestants parties to the proceedings. Salt Lake City, Utah 84111 at (801) 324– Take notice that on May 14, 2004, This filing is available for review at the 2459 or [email protected]. Tennessee Gas Pipeline Company, Commission in the Public Reference Questar asserts that the delivery (Tennessee) tendered for filing certain Room or may be viewed on the lateral would extend from the western exhibits to two amendments to two Gas Commission’s Web site at http:// terminus of Questar’s Main Line No. Transportation Agreements, dated www.ferc.gov using the eLibrary link. (ML) 104 to PacifiCorp’s Currant Creek November 1, 2002, between Tennessee Enter the docket number excluding the Power Project (PacifiCorp’s Project). and Calpine Energy Services L.P. last three digits in the docket number Questar states that its proposed pursuant to Tennessee’s Rate Schedule delivery lateral, to be known as field to access the document. For FT–A (Negotiated Rate Agreements). Jurisdictional Tap Line (JTL) 113, would Tennessee states that its filing is made assistance, please contact FERC Online extend approximately 13.4 miles from in compliance with the Commission’s Support at the west end of Questar’s ML 104 April 30, 2004, Letter Order in the [email protected] or toll- pipeline, near Elberta, in Utah County, referenced docket. free at (866) 208–3676, or TTY, contact Utah, to PacifiCorp’s Project, located In accordance with the Letter Order, (202) 502–8659. The Commission approximately two miles west of the Tennessee requests the amendments to strongly encourages electronic filings. city of Mona in Juab County, Utah. the Negotiated Rate Agreements to be See 18 CFR 385.2001(a)(1)(iii) and the Questar explains that JTL 113 would effective on April 1, 2004. instructions on the Commission’s Web provide transportation service to Any person desiring to be heard or to site under the e-Filing link. PacifiCorp’s Project under a long-term protest said filing should file a motion Magalie R. Salas, Firm Transportation Service Agreement to intervene or a protest with the listed as Exhibit A to the Precedent Federal Energy Regulatory Commission, Secretary. Agreement for Firm Transportation 888 First Street, NE., Washington, DC [FR Doc. E4–1214 Filed 5–25–04; 8:45 am] Service between Questar and 20426, in accordance with § 385.214 or BILLING CODE 6717–01–P PacifiCorp. § 385.211 of the Commission’s rules and

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regulations. All such motions or protests Room or may be viewed on the 2. NM Colton Genco LLC, NM Mid- must be filed in accordance with Commission’s Web site at http:// Valley Genco LLC, NM Milliken Genco § 154.210 of the Commission’s www.ferc.gov using the eLibrary. Enter LLC regulations. Protests will be considered the docket number excluding the last [Docket No. EC04–109–000] by the Commission in determining the three digits in the docket number field Take notice that on May 14, 2004, NM appropriate action to be taken, but will to access the document. For assistance, Colton Genco LLC, NM Mid-Valley not serve to make protestants parties to please contact FERC Online Support at Genco LLC, and NM Milliken Genco the proceedings. Any person wishing to [email protected] or toll- LLC filed with the Commission an become a party must file a motion to free at (866) 208–3676, or TTY, contact application pursuant to section 203 of intervene. This filing is available for (202) 502–8659. The Commission the Federal Power Act for authorization review at the Commission in the Public strongly encourages electronic filings. for the change in control of Reference Room or may be viewed on See 18 CFR 385.2001(a)(1)(iii) and the jurisdictional facilities resulting from the Commission’s Web site at http:// instructions on the Commission’s Web the upstream change in ownership of www.ferc.gov using the eLibrary. Enter site under the e-Filing link. NM Colton Genco LLC, NM Mid-Valley the docket number excluding the last Comment Date: May 25, 2004. Genco LLC and NM Milliken Genco three digits in the docket number field Magalie R. Salas, LLC. to access the document. For assistance, Comment Date: June 4, 2004. please contact FERC Online Support at Secretary. [email protected] or toll- [FR Doc. E4–1215 Filed 5–25–04; 8:45 am] 3. Soyland Power Cooperative, Inc. free at (866) 208–3676, or TTY, contact BILLING CODE 6717–01–P [Docket No. ER04–629–001] (202) 502–8659. The Commission Take notice that on May 14, 2004, strongly encourages electronic filings. Soyland Power Cooperative, Inc. See 18 CFR 385.2001(a)(1)(iii) and the DEPARTMENT OF ENERGY (Soyland) tendered for filing revised rate instructions on the Commission’s Web sheets in compliance with the Federal Energy Regulatory site under the e-Filing link. Commission’s April 22, 2004, letter Commission Magalie R. Salas, order in Docket No. ER04–629–000. Secretary. Comment Date: June 4, 2004. [Docket No. EC04–180–000, et al.] [FR Doc. E4–1209 Filed 5–25–04; 8:45 am] 4. Western Systems Power Pool, Inc. BILLING CODE 6717–01–P Tejas Energy NS, LLC, et al.; Electric [Docket No. ER04–777–000] Rate and Corporate Filings Take notice that on May 17, 2004, the DEPARTMENT OF ENERGY May 18, 2004. Western Systems Power Pool, Inc. (WSPP) requested amendment of the Federal Energy Regulatory The following filings have been made WSPP Agreement to include Citigroup Commission with the Commission. The filings are Energy, Inc. (CEI) and Direct Energy listed in ascending order within each Marketing, Inc. (DEM) as participants. [Docket No. RP04–298–000] docket classification. The WSPP seeks an effective date of Trailblazer Pipeline Company; Notice 1. Tejas Energy NS, LLC, Tejas Coral January 26, 2004, for DEM’s of Revenue Report Energy, LLC, Tenaska Gateway membership and February 18, 2004, for Partners, Ltd., Osaka Gas Gateway CEI’s membership. May 19, 2004. Power, LLC, and Osaka Rusk Gateway WSPP states that copies of this filing Take notice that on May 14, 2004, Power, LLC will be served upon Mark Sickafoose, Trailblazer Pipeline Company Director of Global Commodities for CEI; (Trailblazer) tendered for filing its [Docket No. EC04–108–000] Margaret Moore and Vincenzo Franco of report to inform the Commission of Take notice that on May 14, 2004, Van Ness Feldman, P.C., counsel to CEI; penalty revenues it has received in the Tejas Energy NS, LLC, Tejas Coral and John Messenger, Power Trader for quarter ended March 31, 2004. Energy, LLC (together, the Tejas Parties), DEM. In addition, WSPP states that Trailblazer states that copies of the Tenaska Gateway Partners, Ltd. copies will be e-mailed to WSPP filing are being mailed to its customers (Tenaska Gateway), Osaka Gas Gateway members who have supplied e-mail and interested state commissions. Power, LLC and Osaka Gas Rusk Power, addresses for the Contract Committee Any person desiring to be heard or to LLC (together, the Osaka Parties) and Contacts lists and that the filing has protest said filing should file a motion (collectively, Applicants) filed with the been posted on the WSPP home page to intervene or a protest with the Federal Energy Regulatory Commission (http://www.wsp.org). Federal Energy Regulatory Commission, a joint application requesting Comment Date: June 4, 2004. 888 First Street, NE., Washington, DC authorization under section 203 of the 5. PPL Electric Utilities Corporation 20426, in accordance with § 385.214 or Federal Power Act for the Tejas Parties [Docket No. ER04–843–000] § 385.211 of the Commission’s rules and to transfer all of their respective regulations. All such motions or protests partnership interests in Tenaska Take notice that on May 14, 2004, PPL must be filed on or before the date as Gateway, an 845 MW natural gas-fired Electric Utilities Corporation (PPL indicated below. Protests will be combined cycle power plant located in Electric) filed an Interchange considered by the Commission in Rusk County, Texas, to the Osaka Scheduling Agreement between PPL determining the appropriate action to be Parties. Electric and Waymart Wind Farm L.P. taken, but will not serve to make (Waymart) that sets forth the terms and protestants parties to the proceedings. Applicants state that copies of the conditions with respect to the Any person wishing to become a party application were served upon the Public scheduling of the output of the Waymart must file a motion to intervene. This Utility Commission of Texas and Coral Wind Farm Generating Station. PPL filing is available for review at the Power L.L.C. Electric requests an effective date of Commission in the Public Reference Comment Date: June 4, 2004. January 1, 2004.

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PPL Electric states that a copy of this Federal Energy Regulatory Commission, For additional information contact filing has been provided to Waymart. 888 First Street, NE., Washington, DC David Swearingen at (202) 502–6173 or Comment Date: June 4, 2004. 20426, in accordance with rules 211 and e-mail [email protected]. 214 of the Commission’s rules of 6. Conservation Services Group Magalie R. Salas, practice and procedure (18 CFR 385.211 [Docket No. ER04–844–000] and 385.214). Protests will be Secretary. Take notice that on May 14, 2004, considered by the Commission in [FR Doc. E4–1216 Filed 5–25–04; 8:45 am] Conservation Services Group (CSG) filed determining the appropriate action to be BILLING CODE 6717–01–P an Agreement for Supplemental taken, but will not serve to make Installed Capacity Southwest protestants parties to the proceeding. Connecticut (C&LM Resources) between Any person wishing to become a party DEPARTMENT OF ENERGY ISO New England, Inc. and CSG must file a motion to intervene. All such pursuant to the Commission’s order Federal Energy Regulatory motions or protests should be filed on Commission issued February 27, 2004, in Docket No. or before the comment date, and, to the ER04–335–000, New England Power extent applicable, must be served on the Pool, 106 FERC ¶ 61,190 (2004). CSG applicant and on any other person [Docket No. RM98–1–000] states that the Agreement was entered designated on the official service list. pursuant to ISO New England’s issuance Records Governing Off-the Record This filing is available for review at the Communications; Public Notice of a Gap Request for Proposal to provide Commission or may be viewed on the load response and load management in Commission’s Web site at http:// May 19, 2004. southwestern Connecticut, and CSG www.ferc.gov, using the ‘‘FERRIS’’ link. This constitutes notice, in accordance shall provide such service beginning Enter the docket number excluding the with 18 CFR 385.2201(b), of the receipt June 1, 2004. last three digits in the docket number of exempt and prohibited off-the-record Comment Date: June 4, 2004. filed to access the document. For communications. 7. Western Electricity Coordinating assistance, call (202) 502–8222 or TTY, Order No. 607 (64 FR 51222, Council (202) 502–8659. Protests and September 22, 1999) requires interventions may be filed electronically [Docket No. ER04–845–000] Commission decisional employees, who via the Internet in lieu of paper; see 18 make or receive an exempt or prohibited Take notice that on May 14, 2004, the CFR 385.2001(a)(1)(iii) and the Western Electricity Coordinating off-the-record communication relevant instructions on the Commission’s Web to the merit’s of a contested on-the- Council (WECC) filed with the site under the ‘‘e-Filing’’ link. The Commission (1) an amendment to the record proceeding, to deliver a copy of Commission strongly encourages the communication, if written, or a Reliability Criteria Agreement under the electronic filings. WECC’s Reliability Management System summary of the substance of any oral adding Puget Sound Energy as a Magalie R. Salas, communication, to the Secretary. Participating Transmission Owner and Prohibited communications will be Secretary. included in a public, non-decisional file (2) a Reliability Management System [FR Doc. E4–1217 Filed 5–25–04; 8:45 am] Agreement dated April 27, 2004, associated with, but not a part of, the BILLING CODE 6717–01–P between WECC and Puget Sound Energy decisional record of the proceeding. (collectively the Agreements). The Unless the Commission determines that the prohibited communication and any WECC requests that the Commission DEPARTMENT OF ENERGY issue an order by June 25, 2004, responses thereto should become a part of the decisional record, the prohibited approving the Agreements with a July 1, Federal Energy Regulatory off-the-record communication will not 2004, effective date. Commission Comment Date: June 4, 2004. be considered by the Commission in reaching its decision. Parties to a 8. EnerNOC, Inc. [Docket Nos. CP04–223–000 and CP04–293– proceeding may seek the opportunity to 000] [Docket No. ER04–846–000] respond to any facts or contentions made in a prohibited off-the-record Please take notice that on May 14, KeySpan LNG, L.P.; Notice of Site Visit 2004, EnerNOC, Inc. (EnerNOC) communication, and may request that petitioned the Commission for an order: May 19, 2004. the Commission place the prohibited communication and responses thereto (1) Accepting for filing EnerNOC’s Rate On June 4, 2004, the Office of Energy Schedule FERC No. 1; (2) accepting for in the decisional record. The Projects (OEP) staff will conduct a pre- Commission will grant such a request filing Service Agreement No. 1 to certification site visit of KeySpan LNG, EnerNOC’s Rate Schedule FERC No. 1; only when it determines that fairness so L.P.’s (KeySpan LNG) liquefied natural requires. Any person identified below as (3) granting waiver of certain gas storage facility in Providence, Rhode requirements of the Commission’s having made a prohibited off-the-record Island. We will view the site of the communication shall serve the regulations; and (4) granting the blanket proposed facility upgrade and a planned approvals normally accorded to sellers document on all parties listed on the pipeline route. Examination will be by official service list for the applicable permitted to sell at market-based rates. automobile and on foot. Representatives EnerNOC also requests that the proceeding in accordance with rule of KeySpan LNG will be accompanying 2010, 18 CFR 385.2010. Commission grant waiver of the 60-day the OEP staff. prior notice requirement to allow an Exempt off-the-record effective date of June 1, 2004. All interested parties may attend. communications will be included in the Comment Date: June 4, 2004. Those planning to attend must provide decisional record of the proceeding, their own transportation. Those unless the communication was with a Standard Paragraph interested in attending should meet at 9 cooperating agency as described by 40 Any person desiring to intervene or to a.m. (e.s.t.) at the KeySpan LNG facility CFR 1501.6, made under 18 CFR protest this filing should file with the at 121 Terminal Road, Providence. 385.2201(e)(1)(v).

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The following is a list of prohibited in the Public Reference Room or may be document. For Assistance, please and exempt communications recently viewed on the Commission’s Web site at contact FERC, Online Support at received in the Office of the Secretary. http://www.ferc.gov using the eLibrary [email protected] or toll The communications listed are grouped (FERRIS) link. Enter the docket number free at (866) 208–3676, or for TTY, by docket numbers. These filings are excluding the last three digits in the contact (202) 502–8659. available for review at the Commission docket number field to access the

PROHIBITED

Docket No. Date filed Presenter or requester

1. CP04–58–000 ...... 5–10–04 Robert & Virginia Ilardi, et al.1 1 This communication is one among numerous form letters sent to the Commission by the Greenpeace, USA organization. Only representative samples of these prohibited non-decisional documents are posted in this docket on the Commission’s eLibrary system (http://www.ferc.gov).

EXEMPT

Docket No. Date filed Presenter or requester

1. ER04–691–000 ...... 5–15–04 Marshall Johnson 2. Project No. 2082–000 ...... 5–12–04 Michael Carrier 3. Project No. 2082–000 ...... 5–12–04 Toby Freeman 4. Project No. 2082–000 ...... 5–12–04 Leaf G. Hillman 5. Project No. 2082–000 ...... 5–12–04 Thomas F. King 6. Project No. 2082–000 ...... 5–12–04 Todd Olson 2 7. Project No. 2114–000 ...... 5–13–04 Leon Hoepner 2 Three communications from Todd Olson were filed 5–12–04 in Project No. 2082–000.

Magalie R. Salas, dimethylformamide; nitric acid; nitric I. General Information Secretary. oxide; nitrogen dioxide; oleum; A. Does this Action Apply to Me? [FR Doc. E4–1213 Filed 5–25–04; 8:45 am] peracetic acid; phenyl dichloroarsine; BILLING CODE 6717–01–P sulfur dioxide; sulfur trioxide; sulfuric This action is directed to the public acid; trichloroethylene; and in general. This action may be of trimethylchlorosilane. particular interest to anyone who may be affected if the AEGL values are DATES: A meeting of the NAC/AEGL ENVIRONMENTAL PROTECTION adopted by government agencies for Committee will be held from 9 a.m. to AGENCY emergency planning, prevention, or 5:30 p.m. on June 14, 2004; 8:30 a.m. to response programs, such as EPA’s Risk [OPPT–2004–0093; FRL–7358–8] 5:30 p.m. on June 15, 2004, and from 8 Management Program under the Clean a.m. to noon on June 16, 2004. National Advisory Committee for Acute Air Act and Amendments Section 112r. Exposure Guideline Levels for ADDRESSES: The meeting will be held at It is possible that other Federal agencies Hazardous Substances; Notice of the Movenpick Hotel Voorburg, The besides EPA, as well as State agencies Public Meeting Netherlands (located in the outskirts of and private organizations, may adopt The Hague), Stationsplein 8, NL–2275 the AEGL values for their programs. As AGENCY: Environmental Protection AZ Voorburg (Den Haag). Telephone: + such, the Agency has not attempted to Agency (EPA). 31 70 337 37 37; Fax +31 70 337 37 00; describe all the specific entities that ACTION: Notice. E-mail: hotel.den- may be affected by this action. If you [email protected]; Internet: have any questions regarding the SUMMARY: A meeting of the National www.movenpick-voorburg.com. applicability of this action to a Advisory Committee for Acute Exposure FOR FURTHER INFORMATION CONTACT: particular entity, consult the DFO listed Guideline Levels for Hazardous Colby Linter, Regulatory Coordinator, under FOR FURTHER INFORMATION Substances (NAC/AEGL Committee) Environmental Assistance Division CONTACT. will be held on June 14–16, 2004, in The (7408), Office of Pollution Prevention Netherlands. At this meeting, the NAC/ and Toxics, Environmental Protection B. How Can I Get Copies of this AEGL Committee will address, as time Agency, 1200 Pennsylvania Ave., NW., Document and Other Related permits, the various aspects of the acute Washington, DC 20460–0001; telephone Information? toxicity and the development of Acute number (202) 554–1404; e-mail address: 1. Docket. EPA has established an Exposure Guideline Levels (AEGLs) for [email protected]. official public docket for this action the following chemicals: Acetone; For technical information contact: under docket ID number OPPT–2004– acrolein; adamsite; carbon disulfide; Paul S. Tobin, Designated Federal 0093. The official public docket consists chloroacetone; chloroform; 1,4-dioxane; Officer (DFO), Economics, Exposure, of the documents specifically referenced diphenylchloroarsine; epichlorohydrin; and Technology Division (7406M), in this action, any public comments ethyl dichloroarsine; hexane; Lewisite 1: Office of Pollution Prevention and received, and other information related (2-chlorovinyl) dichloroarsine; Lewisite Toxics, 1200 Pennsylvania Ave., NW., to this action. Although, a part of the 2: bis(2-chlorovinyl)chloroarsine; Washington, DC 20460–0001; telephone official docket, the public docket does Lewisite 3: tris(2-chlorovinyl)arsine; number: (202) 564–8557; e-mail address: not include Confidential Business methyl dichloroarsine; methylene [email protected]. Information (CBI) or other information chloride; methyl mercaptan; N,N- SUPPLEMENTARY INFORMATION: whose disclosure is restricted by statute.

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The official public docket is the List of Subjects This listing is not intended to be collection of materials that is available Environmental protection, Chemicals, exhaustive, but rather provides a guide for public viewing at the EPA Docket Hazardous substances, Health. for readers regarding entities likely to be Center, Rm. B102-Reading Room, EPA affected by this action. Other types of West, 1301 Constitution Ave., NW., Dated: May 17, 2004. entities not listed in this unit could also Washington, DC. The EPA Docket Charles M. Auer, be affected. The North American Center is open from 8:30 a.m. to 4:30 Director, Office of Pollution Prevention and Industrial Classification System p.m., Monday through Friday, excluding Toxics. (NAICS) codes have been provided to legal holidays. The EPA Docket Center [FR Doc. 04–11671 Filed 5–25–04; 8:45 am] assist you and others in determining Reading Room telephone number is BILLING CODE 6560–50–S whether this action might apply to (202) 566–1744 and the telephone certain entities. If you have any number for the OPPT Docket, which is questions regarding the applicability of located in EPA Docket Center, is (202) ENVIRONMENTAL PROTECTION this action to a particular entity, consult 566–0280. AGENCY the person listed under FOR FURTHER 2. Electronic access. You may access [OPP–2004–0119; FRL–7357–4] INFORMATION CONTACT. this Federal Register document B. How Can I Get Copies of this electronically through the EPA Internet Mepanipyrim, N-(4-methyl-6-prop-1- Document and Other Related under the ‘‘Federal Register’’ listings at ynlypyrimidin-2-yl) aniline]; Notice of Information? http://www.epa.gov/fedrgstr/. Filing a Pesticide Petition to Establish 1. Docket. EPA has established an An electronic version of the public a Tolerance for a Certain Pesticide official public docket for this action docket is available through EPA’s Chemical in or on Food under docket identification (ID) number electronic public docket and comment AGENCY: Environmental Protection OPP–2004–0119. The official public system, EPA Dockets. You may use EPA Agency (EPA). docket consists of the documents Dockets at http://www.epa.gov/edocket/ ACTION: Notice. specifically referenced in this action, to submit or view public comments, any public comments received, and access the index listing of the contents SUMMARY: This notice announces the other information related to this action. of the official public docket, and to initial filing of a pesticide petition Although, a part of the official docket, access those documents in the public proposing the establishment of the public docket does not include docket that are available electronically. regulations for residues of a certain Confidential Business Information (CBI) Although, not all docket materials may pesticide chemical in or on various food or other information whose disclosure is be available electronically, you may still commodities. restricted by statute. The official public access any of the publicly available DATES: Comments, identified by docket docket is the collection of materials that docket materials through the docket is available for public viewing at the facility identified in Unit I.B.1. Once in ID number OPP–2004–0119, must be received on or before June 25, 2004. Public Information and Records the system, select ‘‘search,’’ then key in Integrity Branch (PIRIB), Rm. 119, ADDRESSES: Comments may be the appropriate docket ID number. Crystal Mall #2, 1921 Jefferson Davis submitted electronically, by mail, or Hwy., Arlington, VA. This docket II. Meeting Procedures through hand delivery/courier. Follow facility is open from 8:30 a.m. to 4 p.m., For additional information on the the detailed instructions as provided in Monday through Friday, excluding legal SUPPLEMENTARY scheduled meeting, the agenda of the Unit I. of the holidays. The docket telephone number NAC/AEGL Committee, or the INFORMATION. is (703) 305–5805. submission of information on chemicals FOR FURTHER INFORMATION CONTACT: 2. Electronic access. You may access to be discussed at the meeting, contact Mary Waller, Registration Division this Federal Register document the DFO listed under FOR FURTHER (7505C), Office of Pesticide Programs, electronically through the EPA Internet INFORMATION CONTACT. Environmental Protection Agency, 1200 under the‘‘Federal Register’’ listings at The meeting of the NAC/AEGL Pennsylvania Ave., NW., Washington, http://www.epa.gov/fedrgstr/. Committee will be open to the public. DC 20460–0001; telephone number: An electronic version of the public Oral presentations or statements by (703) 308–9354; e-mail address: docket is available through EPA’s interested parties will be limited to 10 [email protected]. electronic public docket and comment minutes. Interested parties are system, EPA Dockets. You may use EPA SUPPLEMENTARY INFORMATION: encouraged to contact the DFO to Dockets at http://www.epa.gov/edocket/ schedule presentations before the NAC/ I. General Information to submit or view public comments, AEGL Committee. Since seating for access the index listing of the contents A. Does this Action Apply to Me? outside observers may be limited, those of the official public docket, and to wishing to attend the meeting as You may be potentially affected by access those documents in the public observers are also encouraged to contact this action, if you are an agricultural docket that are available electronically. the DFO at the earliest possible date to producer, food manufacturer, or Although, not all docket materials may ensure adequate seating arrangements. pesticide manufacturer. Potentially be available electronically, you may still Inquiries regarding oral presentations affected entities may include, but are access any of the publicly available and the submission of written not limited to: docket materials through the docket statements or chemical-specific • Crop Production (NAICS code facility identified in Unit I.B.1. Once in information should be directed to the 111) the system, select ‘‘search,’’ then key in DFO. • Animal Production (NAICS code the appropriate docket ID number. 112) Certain types of information will not III. Future Meetings • Food Manufacturing (NAICS code be placed in the EPA Dockets. Another meeting of the NAC/AEGL 311) Information claimed as CBI and other Committee is scheduled for September • Pesticide Manufacturing (NAICS information whose disclosure is 21–23, 2004, in Washington, DC. code 32532) restricted by statute, which is not

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included in the official public docket, marked ‘‘late.’’ EPA is not required to you mail to the mailing address will not be available for public viewing consider these late comments. If you identified in Unit I.C.2. These electronic in EPA’s electronic public docket. EPA’s wish to submit CBI or information that submissions will be accepted in policy is that copyrighted material will is otherwise protected by statute, please WordPerfect or ASCII file format. Avoid not be placed in EPA’s electronic public follow the instructions in Unit I.D. Do the use of special characters and any docket but will be available only in not use EPA Dockets or e-mail to submit form of encryption. printed, paper form in the official public CBI or information protected by statute. 2. By mail. Send your comments to: docket. To the extent feasible, publicly 1. Electronically. If you submit an Public Information and Records available docket materials will be made electronic comment as prescribed in this Integrity Branch (PIRIB) (7502C), Office available in EPA’s electronic public unit, EPA recommends that you include of Pesticide Programs (OPP), docket. When a document is selected your name, mailing address, and an e- Environmental Protection Agency, 1200 from the index list in EPA Dockets, the mail address or other contact Pennsylvania Ave., NW., Washington, system will identify whether the information in the body of your DC 20460–0001, Attention: Docket ID document is available for viewing in comment. Also, include this contact number OPP–2004–0119. EPA’s electronic public docket. information on the outside of any disk 3. By hand delivery or courier. Deliver Although, not all docket materials may or CD ROM you submit, and in any your comments to: Public Information be available electronically, you may still cover letter accompanying the disk or and Records Integrity Branch (PIRIB), access any of the publicly available CD ROM. This ensures that you can be Office of Pesticide Programs (OPP), docket materials through the docket identified as the submitter of the Environmental Protection Agency, Rm. facility identified in Unit I.B.1. EPA comment and allows EPA to contact you 119, Crystal Mall #2, 1921 Jefferson intends to work towards providing in case EPA cannot read your comment Davis Hwy., Arlington, VA, Attention: electronic access to all of the publicly due to technical difficulties or needs Docket ID number OPP–2004–0119. available docket materials through further information on the substance of Such deliveries are only accepted EPA’s electronic public docket. your comment. EPA’s policy is that EPA during the docket’s normal hours of For public commenters, it is will not edit your comment, and any operation as identified in Unit I.B.1. important to note that EPA’s policy is identifying or contact information that public comments, whether provided in the body of a comment will D. How Should I Submit CBI to the submitted electronically or on paper, be included as part of the comment that Agency? will be made available for public is placed in the official public docket, Do not submit information that you viewing in EPA’s electronic public and made available in EPA’s electronic consider to be CBI electronically docket as EPA receives them and public docket. If EPA cannot read your through EPA’s electronic public docket without change, unless the comment comment due to technical difficulties or by e-mail. You may claim contains copyrighted material, CBI, or and cannot contact you for clarification, information that you submit to EPA as other information whose disclosure is EPA may not be able to consider your CBI by marking any part or all of that restricted by statute. When EPA comment. information as CBI (if you submit CBI identifies a comment containing i. EPA Dockets. Your use of EPA’s on disk or CD ROM, mark the outside copyrighted material, EPA will provide electronic public docket to submit of the disk or CD ROM as CBI and then a reference to that material in the comments to EPA electronically is version of the comment that is placed in EPA’s preferred method for receiving identify electronically within the disk or EPA’s electronic public docket. The comments. Go directly to EPA Dockets CD ROM the specific information that is entire printed comment, including the at http://www.epa.gov/edocket/, and CBI). Information so marked will not be copyrighted material, will be available follow the online instructions for disclosed except in accordance with in the public docket. submitting comments. Once in the procedures set forth in 40 CFR part 2. Public comments submitted on system, select ‘‘search,’’ and then key in In addition to one complete version of computer disks that are mailed or docket ID number OPP–2004–0119. The the comment that includes any delivered to the docket will be system is an ‘‘anonymous access’’ information claimed as CBI, a copy of transferred to EPA’s electronic public system, which means EPA will not the comment that does not contain the docket. Public comments that are know your identity, e-mail address, or information claimed as CBI must be mailed or delivered to the docket will be other contact information unless you submitted for inclusion in the public scanned and placed in EPA’s electronic provide it in the body of your comment. docket and EPA’s electronic public public docket. Where practical, physical ii. E-mail. Comments may be sent by docket. If you submit the copy that does objects will be photographed, and the e-mail to [email protected], not contain CBI on disk or CD ROM, photograph will be placed in EPA’s Attention: Docket ID number OPP– mark the outside of the disk or CD ROM electronic public docket along with a 2004–0119. In contrast to EPA’s clearly that it does not contain CBI. brief description written by the docket electronic public docket, EPA’s e-mail Information not marked as CBI will be staff. system is not an ‘‘anonymous access’’ included in the public docket and EPA’s system. If you send an e-mail comment electronic public docket without prior C. How and to Whom Do I Submit directly to the docket without going notice. If you have any questions about Comments? through EPA’s electronic public docket, CBI or the procedures for claiming CBI, You may submit comments EPA’s e-mail system automatically please consult the person listed under electronically, by mail, or through hand captures your e-mail address. E-mail FOR FURTHER INFORMATION CONTACT. delivery/courier. To ensure proper addresses that are automatically E. What Should I Consider as I Prepare receipt by EPA, identify the appropriate captured by EPA’s e-mail system are My Comments for EPA? docket ID number in the subject line on included as part of the comment that is the first page of your comment. Please placed in the official public docket, and You may find the following ensure that your comments are made available in EPA’s electronic suggestions helpful for preparing your submitted within the specified comment public docket. comments: period. Comments received after the iii. Disk or CD ROM. You may submit 1. Explain your views as clearly as close of the comment period will be comments on a disk or CD ROM that possible.

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2. Describe any assumptions that you Inc., 11 Martine Ave., 9th Floor, White Tomato residue field trials were used. Plains, NY, 10606 proposing, pursuant conducted in Italy and Spain. Combined 3. Provide copies of any technical to section 408(d) of the Federal Food, residues of mepanipyrim and its information and/or data you used that Drug, and Cosmetic Act (FFDCA), 21 regulated metabolite were all less than support your views. U.S.C. 346a(d), to amend 40 CFR part the proposed 0.5 ppm tolerance. Grape 4. If you estimate potential burden or 180, by establishing import tolerances and tomato crops both have processed costs, explain how you arrived at the for residues of menpanipyrim N- (4- commodities. Grape processed estimate that you provide. methyl-6-prop-1-ynlypyrimidin-2-yl) commodities are grape, juice; grape, 5. Provide specific examples to aniline in or on the raw agricultural raisin; and grape, wine. Tomato illustrate your concerns. commodities grape at 2.0 parts per processed commodities are tomato paste 6. Make sure to submit your million (ppm); grape, raisin at 4.0 ppm; and tomato puree. These processed comments by the deadline in this strawberry at 1.5 ppm; and tomato at 0.5 commodities could be imported into the notice. ppm. EPA has determined that the United States. Grape and tomato 7. To ensure proper receipt by EPA, petition contains data or information processing studies indicate that be sure to identify the docket ID number regarding the elements set forth in mepanipyrim residues concentrate in assigned to this action in the subject section 408(d)(2) of FFDCA; however, grape, raisin but do not concentrate in line on the first page of your response. EPA has not fully evaluated the other processed commodities of grape or You may also provide the name, date, sufficiency of the submitted data at this in the processed commodities of tomato. and Federal Register citation. time or whether the data support Tolerances are not required for grape, II. What Action is the Agency Taking? granting of the petition. Additional data juice derived from mepanipyrim treated may be needed before EPA rules on the grape or from tomato, paste and tomato, EPA has received a pesticide petition petition. puree derived from mepanipyrim as follows proposing the establishment treated tomato. A tolerance of 4.0 ppm and/or amendment of regulations for A. Residue Chemistry is needed for the processed commodity residues of a certain pesticide chemical 1. Plant metabolism. The nature of the grape, raisin. in or on various food commodities residues of mepanipyrim in plants is No livestock feed items are associated under section 408 of the Federal Food, adequately understood. Metabolism with the crops for which tolerances are Drug, and Cosmetic Act (FFDCA), 21 studies on apples, grapes, and tomatoes proposed in this petition. Therefore, no U.S.C. 346a. EPA has determined that have been conducted. The major residue livestock residue tolerances are being this petition contains data or is comprised of unchanged parent proposed. information regarding the elements set compound with small amounts of the forth in FFDCA section 408(d)(2); metabolite 1 (2-anilino-6- B. Toxicological Profile however, EPA has not fully evaluated methylpyrimidin-4-yl)-2-propanol and 1. Acute toxicity. Mepanipyrim has a the sufficiency of the submitted data at other metabolites. Parent compound and very-low order of acute toxicity this time or whether the data support 1(2-anilino-6-methylpyrimidin-4-yl)-2- demonstrated by an acute oral LD50 in granting of the petition. Additional data propanol are the only residues of rats (both sexes) greater than 5,000 may be needed before EPA rules on the concern. milligrams/kilogram/body weight (mg/ petition. 2. Analytical method. An analytical kg/bwt). List of Subjects method for measuring residues of 2. Genotoxicity. A battery of in vitro mepanipyrim and the metabolite 1(2- and in vivo tests were conducted to Environmental protection, anilino-6-methylpyrimidin-4-yl)-2- determine the genotoxic potential of Agricultural commodities, Feed propanol has been submitted to EPA. mepanipyrim. Mepanipyrim did not additives, Food additives, Pesticides The analytical method utilizes gas produce lethal DNA damage in three and pests, Reporting and recordkeeping strains of E. coli: WP2, WP67, and requirements. chromatography with a thermionic nitrogen specific detector (NPD). A CM871. Mepanipyrim was active in the Dated: May 6, 2004. confirmatory method utilizes an Ames reverse gene mutation assay, with Lois Rossi, alternate chromatographic column. The or without metabolic activation, Director, Registration Division, Office of confirmatory method is also, employing five strains of Salmonella Pesticide Programs. quantitative. These methods can be used typhimurium (TA 98, TA 100, TA 1538, TA 1535, and TA 1537) and one strain Summary of Petition for gathering residue data and for enforcement purposes. of E.coli (WP2). Mepanipyrim did not The petitioner’s summary of the 3. Magnitude of residues. Residue produce unscheduled DNA synthesis in pesticide petition is printed below as field trials were conducted in cultured human cells (HeLa S-3) either required by FFDCA section 408(d)(3). representative countries that will export in the presence or absence of S-9 The summary of the petition was the majority of the treated commodities metabolic activation. In vivo prepared by K-I Chemical U.S.A., Inc. to the United States. chromosomal aberration assays (CD-1 and represents the view of the Grape residue field trials were mouse micronucleus and CD rat petitioner. The petition summary conducted in Austria, France, Germany, clastogenicity) were both negative when announces the availability of a Italy, Portugal, and Spain. Combined compared to the positive control, description of the analytical methods residues of mepanipyrim and its chlorambucil. In vitro chromosomal available to EPA for the detection and regulated metabolite were all less than aberrations were assayed in Chinese measurement of the pesticide chemical the proposed 2.0 ppm tolerance for hamster ovary (CHO-K1) cells, with and residues or an explanation of why no grapes. without metabolic activation S-9 such method is needed. Strawberry residue field trials were mixture. Mepanipyrim did not show K-I Chemical U.S.A., Inc. conducted in Belgium, France and clastogenic activity in the activated Spain. Combined residues of assay; however, a questionable increase PP 8E5017 mepanipyrim and its regulated in aberrant cell frequency was produced EPA has received a pesticide petition metabolite were all less than the in the non-activated assay. This increase PP 8E5017 from K-I Chemical U.S.A., proposed 1.5 ppm tolerance. of aberrant cell frequency occurred only

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where the number of analyzable be 750 mg/kg bwt. The NOAEL for the 4,000 ppm. The livers of both sexes at metaphases was significantly reduced. study is 750 mg/kg bwt/day. the 4,000 ppm level had a yellow Mepanipyrim was negative in an in vitro A range-finding reproduction study pigment, showed fatty changes and specific locus gene mutation assay in was conducted at 200; 1,000; 2,500; and granulation of the liver cells. The cultured Chinese hamster (V79) cells as 5,000 ppm using 6 male and 6 female NOAEL in the 13–week oral rat studies the hypoxanthine-guanine- Charles River rats and evaluating the is 13.8 mg/kg bwt/day in males and 15.3 phosphoribosyl transferase locus. In effects on a single litter per mating. mg/kg bwt/day in females (200 ppm). summary, mepanipyrim was not Adult body weight gain was decreased In a 13–week oral study with mice genotoxic and did not induce heritable at doses of 1,000; 2,500; and 5,000 ppm dosed at 0; 100; 1,000; 3,000; and 7,000 effects in the assays conducted. in the diet. No adverse effects on ppm pathological examination revealed 3. Reproductive and developmental reproductive parameters were no abnormal gross findings in liver and toxicity. A developmental toxicity study determined. A NOAEL of 200 ppm was kidney, although, absolute and relative was conducted in rabbits at doses of 0, assessed for this study. liver and kidney weights were 10, 30, and 90 mg/kg bwt/day. Doses of A 2-generation reproduction study significantly increased in both sexes at 30, and 90 mg/kg bwt/day produced was conducted in Charles River CD rats 3,000 ppm. Histologic observations were marginal reductions in body weight gain using 28 males/females per dose. No limited to few organs and compound- and an increased incidence of reproductive effects were evident at related effects were not demonstrated. premature delivery or abortion on days doses up to and including 2,000 ppm. The NOAEL in the mouse is 18.8 mg/ 28 and 29 of gestation. There was an Liver weights were increased in parent kg bwt/day in males and 22 mg/kg bwt/ increased percentage of small and extra and offspring, as well as day for females. small anterior fontanelle, an increased histopathological changes at 1,000 ppm In a 13–week oral study with beagle (i.e., hepatocytic fatty vacuolation). dogs dosed at 0, 15, 50, or 150 mg/kg percentage of anomalous interparietal Tubular germinal epithelial bwt/day, body weight gain for high dose bones fissured or reduced, and an degeneration was observed in F A and females was significantly decreased increased percentage of incompletely 2 F B males at 1,000 ppm, with interstitial (p<0.001). Relative organ weight ossified and unossified centrales in all 2 cell hyperplasia at 150 ppm. An overall increases were observed at the highest dosed groups. However, there was also NOAEL for the study was not dose, as well as alanine amino- an increased incidence of enlarged demonstrated due to adverse effects on transferase (ALT), which was increased medium anterior fontanelle and the liver at 150 ppm. in both sexes. Hematological posterior fontanelle in control fetuses. In a second 2-generation reproduction examination revealed no treatment All indices were within the range of study in Charles River CD rats, 32 related effects. A brown pigment historical controls reported for 15 males/females were given 0, 50, or 150 positively identified as lipofuscin by studies. In view of the percentage of ppm in the diet. The fertility index was Schmorl’s stain was seen in liver cells variations that were evident across all low in control and low-dose groups (i.e., of both sexes at the 15 mg/kg bwt/day groups, including controls, these 69%), with 88% pregnant in the high dose. A NOAEL was not demonstrated sporadic increased incidences are not dose group. All reproductive parameters in this study. The study was repeated at considered to be compound related. The which were evaluated were unaffected 7.5 and 15 mg/kg bwt/day and the developmental no adverse effects level at all dose levels. Liver weights were NOAEL was determined to be 7.5 mg/ (NOAEL) is considered to be 90 mg/kg increased in male and female F1 and F2 kg bwt/day based on the formation of bwt/day; the NOAEL for the study is 10 offspring at 150 ppm, as well as lipofuscin in the liver. mg/kg bwt/day based on maternal hepatocytic periacinar vacuolation in 5. Chronic toxicity—i. Chronic toxicity at higher doses. males. A NOAEL for general toxicity is toxicity/oncogenicity in rat. Rats were A developmental toxicity study was considered to be 50 ppm, with 150 ppm administered mepanipyrim in the diet conducted in pregnant Charles River CD a NOAEL for reproductive parameters. for 104 weeks at doses of 0; 50; 150; rats at doses of 0, 30, 150, and 750 mg/ 4. Subchronic dietary toxicity. Short- 2,000; and 4,000 ppm. Males and kg bwt/day, administered from day 6 term exposure of rats and dogs to females at 2,000 ppm had significant though day 15 of gestation. There were mepanipyrim technical resulted in the decreases in body weight gain, Hct, Hgb, no adverse effects on body weight gain, following effects. MCV, and MCH, also, cholesterol, fetal growth, or morphological In a 13–week oral study with rats triglyceride, phospholipids, and non- development at any dose. The only dosed at 0, 50, 100, 200, and 800 ppm, esterified fatty acid. Significant increase marginal non-dose related effects were there were increased absolute and in relative and absolute liver, kidney, slight increases in unilateral relative liver weights in both sexes. and spleen weights were determined in hydronephrosis and hydroureter at 150 Pathological examination revealed no males and females at 2,000 ppm. and 750 mg/kg. However, these are not specific lesions. In a second 13–week Yellowish enlarged livers occurred in considered compound-related based dietary study in specific pathogen free males and females at 2,000 ppm, as well upon the incidence in bilateral rats dosed at 0; 1,600; and 4,000 ppm, as fatty changes which were increased. hydronephrosis and hydroureter which decreased body weight gain was There was an increased incidence of were increased in controls relative to all observed in both sexes at 4,000 ppm. transitional cell hyperplasia in kidneys treated groups. At 750 mg/kg bwt/day Hematological examinations conducted of males at 2,000 ppm. The incidence of there was a non-significant increase in at 13 weeks revealed decreased hepatocellular adenoma was intramuscular hemorrhage of the hind hematocrit (Hct), hemoglobin levels significantly increased in females at the limb and subcutaneous hemorrhage of (Hgb), mean cell volume (MCV), and high dose. The NOAEL for the study the lower jaw. The effect observed in the mean cell hemoglobin (MCH) in both was 50 ppm (2.45 mg/kg bwt in males hind limb, although, not statistically sexes which were significantly less than and 3.07 mg/kg bwt in females). significant, was outside the historical controls at 4,000 ppm. Reticulocyte ii. Chronic toxicity in the dog. control range, whereas all other effects count, however, was increased at 4,000 Mepanipyrim was administered to dogs were within the historical control range ppm. There were also, significant for 52–weeks at doses of 0, 2.5, 7.5, and of 137 studies reported. The increases in absolute and relative liver 50 mg/kg bwt/day. Body weight gain developmental NOAEL is considered to and kidney weights in both sexes at was decreased in high-dose females.

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Animals receiving 50 mg/kg bwt/day ‘‘Microsomal mixed function oxidase 0.000936 mg/kg bodyweight/day for demonstrated significantly increased activity in liver of rats and mice the general U.S. population; 0.000429 relative liver weights in both sexes and administered with mepanipyrim.’’ mg/kg bodyweight/day for non-nursing hepatocellular enlargement in females. Mepanipyrim was administered for 3 infants; 0.00178 mg/kg body weight/day Alkaline phosphatase (AP) and ALT weeks to rats at dose levels of 150 and of children 1–6 years of age; and were also significantly increased in 4,000 ppm and to mice at 350 and 7,000 0.00118 mg/kg bodyweight/day of high-dose male and females. ppm. The study revealed that at the children 7–12 years of age. Hematologic examination revealed a 4,000 and 7,000 ppm dose levels the The TMRC values are based on the significant increase in neutrophils and microsomal drug-metabolizing enzyme assumption that all of the grape, lymphocytes manifested as a ‘‘left-shift’’ aminopyrine N-demethylase increased strawberry, and tomato and their in the M:E ratio of males and females. slightly in the rat and mouse livers. processed commodities will bear Pigmentation in hepatocytes and Aniline hydroxylase activity was residues at the proposed tolerance levels Kupffer cells, identified as lipofuscin, unchanged in both species. for the raw agricultural commodities. was increased in high-dose males and ‘‘Promoting activities of mepanipyrim These chronic dietary exposure females. The NOAEL for the study was liver carcinogenesis initiated with estimates are very conservative because 7.5 mg/kg bwt/day. dimethylnitrosamine in rats.’’ Rats were they assume that 100% of all grape, iii. Chronic toxicity/oncogenicity in fed a diet containing 1,000 and 5,000 strawberry, and tomato are imported. the mouse. B6C3F1 mice were ppm mepanipyrim for 6 weeks after Imported grapes, strawberry, and tomato administered mepanipyrim in the diet having been injected with actually comprise less than 10% of continuously for 2 years at dose levels nitrosodiethylamine. Mepanipyrim has these commodities consumed in the of 0; 70; 350, 3,500; and 7,000 ppm. a weak promoting effect evidenced by United States. The estimates also Males and females showed increased the induction of gamma-glutamyl assume that all imported grape, relative liver weights at 3,500 ppm. transpeptidase foci in the liver. strawberry, and tomato and their Male mice also had decreased body 6. Animal metabolism. A rat processed products are treated with weights at 7000 ppm. Hematocrit and metobolism study was conducted with mepanipyrim and that residue levels on hemoglobin were decreased in males at 106 rats divided into 13 dose groups. No all of the imported commodities are at 7,000 ppm. Several effects were radioactivity was noted in expired CO2 the proposed tolerance level. observed in the liver, including: or other expired volatiles. The majority Dietary exposure to residues of Increased hepatic nodules (both sexes) of radioactivity was excreted in the mepanipyrim will be from grape, at 3,500 ppm; increased swelling of liver feces. Urine was the other major route strawberry, tomato, and their processed cells in males at 3,500 ppm and in of excretion. The same residues, parent products and also, from grape, and females at 7,000 ppm; and increased and metabolites, were found in both wine. There are no livestock or poultry foci/hyperplasia in males and females at urine and feces. Most of the feed items associated with these raw 3,500 ppm. Incidences of hepatocellular radioactivity had been excreted by 24 commodities. Thus, there will be no adenoma and carcinoma were increased hours after dosing. The majority of the dietary exposure to mepanipyrim in both sexes at 3,500 ppm. A NOAEL radioactivity in blood was acetonitrile residues in meat, milk, poultry, and was demonstrated for non-neoplastic extractable at 5–8 hours after dosing and eggs. There are no other tolerances or effects in both males and females at 350 declined to zero at 120 hours. In bile exemptions from a tolerance for ppm, equal to 56 mg/kg bwt/day in duct cannulated rats, a significant mepanipyrim in the United States. males and 68 mg/kg bwt/day in females. amount (50–70%) of the dose was ii. Drinking water. There are neither Ancillary (non-good labotatory excreted in bile. The percentage of dose tolerances nor registration for the use of practice) studies were conducted to excreted in feces was reduced to 3–4% this chemical in the United States. explore the compound-related effects on at 120 hours. Therefore, there will be no exposure to the liver in rodents. 7. Metabolite toxicology. No mepanipyrim from residues in drinking ‘‘Studies on fatty liver induced by toxicologically significant metabolites water. mepanipyrim in rats.’’ Young adult were detected in plant and rat 2. Non-dietary exposure. This petition Fischer 344 rats were dosed at 4,000 and metabolism studies. is for a tolerance on imported grape, 8,000 ppm for 3 weeks. Various blood 8. Endocrine disruption. No specific strawberry, and tomato. There is no and liver examinations were conducted. tests have been conducted with approved registered use for The results indicate that serum lipid mepanipyrim to determine whether mepanipyrim in the United States, and concentrations decreased in conjunction mepanipyrim may have an effect in none is being sought. Therefore, the with the induction of fatty liver by humans that is similar to an effect potential for non-dietary exposure is not mepanipyrim treatment. produced by a naturally occurring pertinent to this petition. ‘‘Study on the possible oxidative estrogen or other endocrine effects. damage to DNA by mepanipyrim.’’ There is no evidence at this time that D. Cumulative Effects Mepanipyrim was administered to rats mepanipyrim causes endocrine effects, This chemical is in the and mice in a single-oral dose, and in and no reason to suspect that it does anilinopyrimidine class. EPA the diet for 3 and 6 weeks. Livers were based upon the information available consideration of a common mechanism removed at pre-determined times after and mode of action of this class of of toxicity is not appropriate at this time each compound administration regimen, compounds. because EPA has not made a and the DNA extracted. Individual determination that mepanipyrim and samples were assayed for 8- C. Aggregate Exposure other substances may have a common hydroxyquanine (8-OHdG) by high 1. Dietary exposure—i. Food The mechanism of toxicity that would have performance liquid chromatography and Theoretical Maximum Residue a cumulative effect. K-I Chemical enzyme-linked immunosorbant assay. Concentration (TMRC) of mepanipyrim U.S.A., Inc., is considering only the No significant increase in the 8-OHdG in or on grape, strawberry, tomato, and potential risk of mepanipyrim in its (an indicator of oxidative DNA damage) their processed commodities (grape, cumulative-exposure assessment. was observed in rat livers or in the 3 and juice; grape, wine; grape, raisin; tomato, Evidence from rodent studies indicate 6 week exposure periods in mice. paste; and tomato, puree) are as follows: that mepanipyrim may be oncogenic at

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high doses in rodent livers. In the 2– concludes that there is a ‘‘reasonable through hand delivery/courier. Follow year mouse study, at doses of 3,500 and certainty to no harm’’ from aggregate the detailed instructions as provided in 7,000 ppm, hepatocellular adenoma and exposure to mepanipyrim residues. Unit I. of the SUPPLEMENTARY hepatocellular carcinoma of the liver of 2. Infants and children. The chronic INFORMATION. both sexes were statistically dietary exposure estimates will utilize FOR FURTHER INFORMATION CONTACT: significantly increased above those seen approximately 1.8% of the RfD for non- Tawanda Spears, Special Review and in the controls. A slight increase in nursing infants less than 1–year of age, Reregistration Division (7508C), Office hepatocellular adenomas was observed and approximately 7.3% of the RfD for of Pesticide Programs, Environmental in female rats dosed at 4,000 ppm in the children 1–6 years of age, and Protection Agency, 1200 Pennsylvania 2–year rat study. No increase was noted approximately 4.8% for children 7–12 Ave., NW., Washington, DC 20460– at lower doses or in the male rats. years of age. The conservative exposure 0001; telephone number: (703) 308– Additionally, the tumors did not lead to estimates for the infant and children 8050; e-mail address: a shortening of the lifespan of affected populations are all well below the RfD [email protected]. animals and there was no decrease in for mepanipyrim. the time-to-tumor versus the concurrent SUPPLEMENTARY INFORMATION: F. International Tolerances control animals. In the chronic toxicity I. General Information portion of the rat study, there was also, Registration of mepanipyrim is in the observation of hepatic perilobular progress in the European Union (EU). A A. Does this Action Apply to Me? lipogenesis. provisional registration has been This action is directed to the public A complete battery of in vitro and in granted in several countries with in general. This action may, however, be vivo mutagentcity studies were temporary maximum residue levels of interest to persons who are or may be performed to evaluate mepanipyrim’s (tMRL) set. These countries and tMRLs required to conduct testing of chemical ability to induce gene mutations, are: Austria, strawberry and grape (2 substances under the Federal structural chromosomal aberrations, or mg/kg); Belgium, strawberry (2); France, Insecticide, Fungicide, and Rodenticide other genotoxic effects. Mepanipyrim strawberry and grape (2), wine (0.2); Act (FIFRA) or the Federal Food, Drug, showed no evidence of genotoxic Italy, strawberry (2), grape (3), wine and and Cosmetic Act (FFDCA); activity in any of the investigations tomato (1); Luxembourg, strawberry (2), environmental, human health, and performed. grape (3); Netherlands, strawberry (2); agricultural advocates; pesticides users; While mepanipyrim is not genotoxic, Portugal, strawberry and grape (2); and members of the public interested in mepanipyrim demonstrated an ability to Spain, strawberry and grape (2), tomato the use of pesticides. Since other induce gamma glutamyl transferase (1); and United Kingdom, strawberry (2). entities may also be interested, the (GGT) positive liver cell foci and to Mepanipyrim is registered for crop Agency has not attempted to describe all induce the liver’s metabolizing uses in Switzerland, Japan, and Israel. the specific entities that may be affected enzymes. Therefore, mepanipyrim may by this action. If you have any questions be a non-genotoxic carcinogen suggested [FR Doc. 04–11562 Filed 5–25–04; 8:45 am] regarding the applicability of this action by its ability to induce a proliferative BILLING CODE 6560–50–S to a particular entity, consult the person effect in the liver which results in listed under FOR FURTHER INFORMATION increases in spontaneously occurring CONTACT. liver neoplasia in both mice and rats. A ENVIRONMENTAL PROTECTION threshold would exist in this case and AGENCY B. How Can I Get Copies of this Document and Other Related no oncogenic response would be [OPP–2003–0353; FRL–7356–1] anticipated below such a threshold Information? level. In the current studies, no Di-n-propylisocinchomeronate (MGK 1. Docket. EPA has established an hepatocellular tumors or liver toxicity Repellent 326); Availability of official public docket for this action were observed in mice at 350 ppm (56.0 Reregistration Eligibility Decision under docket identification (ID) number mg/kg/day mepanipyrim) and in rats at Document for Comment OPP–2003–0353. The official public 50 ppm (2.45 mg/kg/day mepanipyrim). docket consists of the documents AGENCY: Based on the total information Environmental Protection specifically referenced in this action, examined, mepanipyrim is considered a Agency (EPA). any public comments received, and Group C carcinogen not requiring ACTION: Notice. other information related to this action. quantitative risk assessment. Although a part of the official docket, SUMMARY: This notice announces the public docket does not include availability and starts a 30–day public E. Safety Determination Confidential Business Information (CBI) comment period on the Reregistration 1. U.S. population. The reference dose or other information whose disclosure is (RfD) represents the level at or below Eligibility Decision (RED) document for restricted by statute. The official public the insect repellent di-n- which daily aggregate dietary exposure  docket is the collection of materials that over a lifetime will not pose appreciable propylisocinchomeronate (MGK is available for public viewing at the risks to human health. For Repellent 326). The RED represents Public Information and Records mepanipyrim, the RfD of 0.0245 mg/kg EPA’s formal regulatory assessment of Integrity Branch (PIRIB), Rm. 119, bwt/day is based on a NOAEL of 50 the human health and environmental Crystal Mall #2, 1921 Jefferson Davis ppm or 2.45 mg/kg bwt/day from the data base of the subject chemical and Hwy., Arlington, VA. This docket chronic toxicity/oncogenicity study. presents the Agency’s determination facility is open from 8:30 a.m. to 4 p.m., Considering the extremely conservative regarding which pesticidal uses are Monday through Friday, excluding legal estimates of exposure in comparison to eligible for reregistration. holidays. The docket telephone number the RfD of 0.0245 mg/kg, the chronic DATES: Comments, identified by docket is (703) 305–5805. dietary exposure of the U.S. population ID number OPP–2003–0353, must be 2. Electronic access. You may access will only utilize 3.8% of the RfD. This received on or before June 25, 2004. this Federal Register document exposure is much less than 100% of the ADDRESSES: Comments may be electronically through the EPA Internet RfD and K-I Chemical U.S.A., Inc., submitted electronically, by mail, or under the ‘‘Federal Register’’ listings at

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http://www.epa.gov/fedrgstr/. To access Public comments submitted on system, select ‘‘search,’’ and then key in RED documents and RED fact sheets computer disks that are mailed or docket ID number OPP–2003–0353. The electronically, go directly to the REDs delivered to the docket will be system is an ‘‘anonymous access’’ table on EPA’s Office of Pesticide transferred to EPA’s electronic public system, which means EPA will not Programs Home Page, at http:// docket. Public comments that are know your identity, e-mail address, or www.epa.gov/pesticides/reregistration/ mailed or delivered to the docket will be other contact information unless you status.htm. scanned and placed in EPA’s electronic provide it in the body of your comment. An electronic version of the public public docket. Where practical, physical ii. E-mail. Comments may be sent by docket is available through EPA’s objects will be photographed, and the e-mail to [email protected], electronic public docket and comment photograph will be placed in EPA’s Attention: Docket ID Number OPP– system, EPA Dockets. You may use EPA electronic public docket along with a 2003–0353. In contrast to EPA’s Dockets at http://www.epa.gov/edocket/ brief description written by the docket electronic public docket, EPA’s e-mail to submit or view public comments, staff. system is not an ‘‘anonymous access’’ access the index listing of the contents C. How and to Whom Do I Submit system. If you send an e-mail comment of the official public docket, and to Comments? directly to the docket without going access those documents in the public through EPA’s electronic public docket, docket that are available electronically. You may submit comments EPA’s e-mail system automatically Once in the system, select ‘‘search,’’ electronically, by mail, or through hand captures your e-mail address. E-mail then key in the appropriate docket ID delivery/courier. To ensure proper addresses that are automatically number. receipt by EPA, identify the appropriate captured by EPA’s e-mail system are docket ID number in the subject line on Certain types of information will not included as part of the comment that is the first page of your comment. Please be placed in EPA’s Dockets. Information placed in the official public docket, and ensure that your comments are claimed as CBI and other information made available in EPA’s electronic submitted within the specified comment public docket. whose disclosure is restricted by statute, period. Comments received after the iii. Disk or CD ROM. You may submit which is not included in the official close of the comment period will be comments on a disk or CD ROM that public docket, will not be available for marked ‘‘late.’’ EPA is not required to public viewing in EPA’s electronic consider these late comments. If you you mail to the mailing address public docket. EPA’s policy is that wish to submit CBI or information that identified in Unit I.C.2. These electronic copyrighted material will not be placed is otherwise protected by statute, please submissions will be accepted in in EPA’s electronic public docket but follow the instructions in Unit I.D. Do WordPerfect or ASCII file format. Avoid will be available only in printed, paper not use EPA Dockets or e-mail to submit the use of special characters and any form in the official public docket. To the CBI or information protected by statute. form of encryption. extent feasible, publicly available 1. Electronically. If you submit an 2. By mail. Send your comments to: docket materials will be made available electronic comment as prescribed in this Public Information and Records in EPA’s electronic public docket. When unit, EPA recommends that you include Integrity Branch (PIRIB) (7502C), Office a document is selected from the index your name, mailing address, and an e- of Pesticide Programs (OPP), list in EPA Dockets, the system will mail address or other contact Environmental Protection Agency, 1200 identify whether the document is information in the body of your Pennsylvania Ave., NW., Washington, available for viewing in EPA’s electronic comment. Also include this contact DC 20460–0001, Attention: Docket ID public docket. Although not all docket information on the outside of any disk Number OPP–2003–0353. materials may be available or CD ROM you submit, and in any 3. By hand delivery or courier. Deliver electronically, you may still access any cover letter accompanying the disk or your comments to: Public Information of the publicly available docket CD ROM. This ensures that you can be and Records Integrity Branch (PIRIB), materials through the docket facility identified as the submitter of the Office of Pesticide Programs (OPP), identified in Unit I.B.1. EPA intends to comment and allows EPA to contact you Environmental Protection Agency, Rm. work towards providing electronic in case EPA cannot read your comment 119, Crystal Mall #2, 1921 Jefferson access to all of the publicly available due to technical difficulties or needs Davis Hwy., Arlington, VA, Attention: docket materials through EPA’s further information on the substance of Docket ID Number OPP–2003–0353. electronic public docket. your comment. EPA’s policy is that EPA Such deliveries are only accepted For public commenters, it is will not edit your comment, and any during the docket’s normal hours of important to note that EPA’s policy is identifying or contact information operation as identified in Unit I.B.1. that public comments, whether provided in the body of a comment will D. How Should I Submit CBI to the submitted electronically or in paper, be included as part of the comment that Agency? will be made available for public is placed in the official public docket, viewing in EPA’s electronic public and made available in EPA’s electronic Do not submit information that you docket as EPA receives them and public docket. If EPA cannot read your consider to be CBI electronically without change, unless the comment comment due to technical difficulties through EPA’s electronic public docket contains copyrighted material, CBI, or and cannot contact you for clarification, or by e-mail. You may claim other information whose disclosure is EPA may not be able to consider your information that you submit to EPA as restricted by statute. When EPA comment. CBI by marking any part or all of that identifies a comment containing i. EPA dockets. Your use of EPA’s information as CBI (if you submit CBI copyrighted material, EPA will provide electronic public docket to submit on disk or CD ROM, mark the outside a reference to that material in the comments to EPA electronically is of the disk or CD ROM as CBI and then version of the comment that is placed in EPA’s preferred method for receiving identify electronically within the disk or EPA’s electronic public docket. The comments. Go directly to EPA Dockets CD ROM the specific information that is entire printed comment, including the at http://www.epa.gov/edocket/, and CBI). Information so marked will not be copyrighted material, will be available follow the online instructions for disclosed except in accordance with in the public docket. submitting comments. Once in the procedures set forth in 40 CFR part 2.

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In addition to one complete version of Protection Act (FQPA) of 1996. Operating Common Carrier and Ocean the comment that includes any Therefore, the RED also presents the Freight Forwarder—Ocean information claimed as CBI, a copy of Agency’s tolerance reassessment Transportation Intermediary pursuant to the comment that does not contain the decision for MGK Repellent 326, section 19 of the Shipping Act of 1984 information claimed as CBI must be which included the consideration of as amended (46 U.S.C. app. 1718 and 46 submitted for inclusion in the public risks to infants and children. CFR 515). docket and EPA’s electronic public All registrants of pesticide products Persons knowing of any reason why docket. If you submit the copy that does containing the active ingredient di-n- the following applicants should not not contain CBI on disk or CD ROM, propyl isocinchomeronate will be sent a receive a license are requested to mark the outside of the disk or CD ROM copy of the RED, and must respond to contact the Office of Transportation clearly that it does not contain CBI. labeling requirements and product- Intermediaries, Federal Maritime Information not marked as CBI will be specific data requirements (if Commission, Washington, DC 20573. included in the public docket and EPA’s applicable) within 8 months of receipt. Non-Vessel Operating Common Carrier electronic public docket without prior The reregistration program is being Ocean Transportation Intermediary notice. If you have any questions about conducted under Congressionally Applicants: CBI or the procedures for claiming CBI, mandated time frames, and EPA please consult the person listed under recognizes both the need to make timely Best International Shipping, Inc., 129 FOR FURTHER INFORMATION CONTACT. reregistration decisions and to involve Selandia Lane, Carson, CA 90746. the public. Therefore, EPA is issuing Officers: Eung-Hee Cho, Secretary/ E. What Should I Consider as I Prepare this RED as a final document with a 30– C.F.O., (Qualifying Individual), My Comments for EPA? day comment period. Although the 30– Yoon Jung Cho, President. You may find the following day public comment period does not American Transport Logistics, Inc., 12 suggestions helpful for preparing your affect the registrant’s response due date, Blackfoot Drive, Manalapan, NJ comments: it is intended to provide an opportunity 07726. Officer: Isaac M. Eddi, 1. Explain your views as clearly as for public input and a mechanism for Director, (Qualifying Individual). possible. initiating any necessary amendments to Apex Maritime Co. (LAX), Inc., 20418 2. Describe any assumptions that you the RED. Unless adverse comments are East Walnut Drive North, Walnut, used. received, at the end of the coment CA 91789. Officer: Vicky Cheung, 3. Provide copies of any technical period, the Agency will consider this President, (Qualifying Individual). information and/or data you used that action a final decision. If any comment Non-Vessel Operating Common Carrier support your views. significantly affects a RED, EPA will and Ocean Freight Forwarder 4. If you estimate potential burden or amend the RED by publishing the Transportation Intermediary costs, explain how you arrived at the amendment in the Federal Register. Applicant: estimate that you provide. 5. Provide specific examples to B. What is the Agency’s Authority for Ni Midstar, LLC, 8228 50th Street, illustrate your concerns. Taking this Action? SW., Byron, MN 55920. Officers: Chris Heinz, President, (Qualifying 6. Offer alternative ways to improve The legal authority for these REDs Individual), Kazuo Hondo, Director. the notice or collection activity. falls under FIFRA. Section 4(g)(2)(A) of 7. Make sure to submit your FIFRA directs that, after submission of Ocean Freight Forwarder—Ocean comments by the deadline in this all data concerning a pesticide active Transportation Intermediary document. ingredient, ‘‘the Administrator shall Applicant: 8. To ensure proper receipt by EPA, determine whether pesticides Maharlika Forwarders Travel & Tours, be sure to identify the docket ID number containing such active ingredient are 1545 W. Willow Street, Suite A, assigned to this action in the subject eligible for reregistration,’’ before calling Long Beach, CA 90810, Grace line on the first page of your response. in product-specific data on individual Menez, Sole Proprietor. You may also provide the name, date, end-use products, and either Dated: May 21, 2004. and Federal Register citation. reregistering products or taking ‘‘other Bryant L. VanBrakle, II. Background appropriate regulatory action.’’ Secretary. A. What Action is the Agency Taking? List of Subjects [FR Doc. 04–11920 Filed 5–25–04; 8:45 am] The Agency has issued a RED for the Environmental protection, Chemicals, BILLING CODE 6730–01–P insect repellent MGK Repellent 326. Pesticides and pests. Under the Federal Insecticide, Dated: May 14, 2004. FEDERAL MARITIME COMMISSION Fungicide, and Rodenticide Act Debra Edwards, (FIFRA), EPA is conducting an Director, Special Review and Reregistration Ocean Transportation Intermediary accelerated reregistration program to Division, Office of Pesticide Programs. License Reissuances reevaluate existing pesticides to make [FR Doc. 04–11778 Filed 5–25–04; 8:45 am] sure they meet current scientific and Notice is hereby given that the regulatory standards. The data base to BILLING CODE 6560–50–S following Ocean Transportation support the reregistration of MGK Intermediary licenses have been Repellent 326 is substantially complete reissued by the Federal Maritime and the insect repellent’s risks have FEDERAL MARITIME COMMISSION Commission pursuant to section 19 of  been mitigated so that MGK Repellent Ocean Transportation Intermediary the Shipping Act of 1984, as amended 326 will not pose unreasonable risks to License Applicants by the Ocean Shipping Reform Act of people or the environment when used 1998 (46 U.S.C. app. 1718) and the according to its approved labeling. Notice is hereby given that the regulations of the Commission In addition, EPA is reevaluating following applicants have filed with the pertaining to the licensing of Ocean existing pesticides and reassessing Federal Maritime Commission an Transportation Intermediaries, 46 CFR tolerances under the Food Quality application for license as a Non-Vessel part 515.

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License No. Name/address Date reissued

003568NF ...... CTSI Logistics, Inc., 600 Sylvan Avenue, 24th Floor, Englewood Cliffs, NJ 07632 ...... April 22, 2004. 003110NF ...... International Freight Transport Inc., 88 South Avenue, Fanwood, NJ 07023 ...... November 6, 2003. 003286F ...... Rialto International, Inc., 4636 East Marginal Way South, Suite 201, Seattle, WA 98134 ...... April 14, 2004. 003718F ...... Sunship International Inc., 6815 W. 95th Street, Suite #1, NE., Oak Lawn, IL 60453 ...... April 23, 2004. 003874NF ...... World Project Services, International, Inc., 650 E. North Sam Houston, Parkway, Suite 231, Houston, April 28, 2004. TX 77060.

Sandra L. Kusumoto, License Number: 004290F. pursuant to the Bank Holding Company Director, Bureau of Consumer Complaints Name: Neal Brothers, Inc. Act of 1956 (12 U.S.C. 1841 et seq.) and Licensing. Address: 1255 Necessary Lane, (BHC Act), Regulation Y (12 CFR Part [FR Doc. 04–11922 Filed 5–25–04; 8:45 am] Charleston, SC 29405. 225), and all other applicable statutes BILLING CODE 6730–01–P Date Revoked: April 21, 2004. and regulations to become a bank Reason: Surrendered license holding company and/or to acquire the voluntarily. assets or the ownership of, control of, or FEDERAL MARITIME COMMISSION License Number: 018072N. the power to vote shares of a bank or Name: Oceanair Freight International, bank holding company and all of the Ocean Transportation Intermediary Inc. banks and nonbanking companies License Revocations Address: 4280 NW. 147th Terrace, owned by the bank holding company, The Federal Maritime Commission Opalocka, FL 33054. including the companies listed below. Date Revoked: May 5, 2004. hereby gives notice that the following The applications listed below, as well Reason: Failed to maintain a valid Ocean Transportation Intermediary as other related filings required by the bond. licenses have been revoked pursuant to Board, are available for immediate section 19 of the Shipping Act of 1984 License Number: 018075F. inspection at the Federal Reserve Bank (46 U.S.C. app. 1718) and the Name: Rapidus, LLC. indicated. The application also will be Address: 3345 NW. 116th Street, regulations of the Commission available for inspection at the offices of Miami, FL 33167. pertaining to the licensing of Ocean the Board of Governors. Interested Date Revoked: December 2, 2003. Transportation Intermediaries, effective persons may express their views in Reason: Surrendered license writing on the standards enumerated in on the corresponding date shown below: voluntarily. License Number: 002652NF. the BHC Act (12 U.S.C. 1842(c)). If the Name: IFF, Inc. License Number: 004405F. proposal also involves the acquisition of Address: 452–A Plaza Drive, P.O. Box Name: Robert William Cisco dba a nonbanking company, the review also 45505, Atlanta, GA 30320. Robert W. Cisco Customhouse Broker. includes whether the acquisition of the Date Revoked: May 13, 2004. Address: 200 Box 32 Bldg. 14 B–1, nonbanking company complies with the Reason: Failed to maintain valid 200 Crofton Road, Kenner, LA 70062. standards in section 4 of the BHC Act bonds. Date Revoked: May 1, 2004. (12 U.S.C. 1843). Unless otherwise Reason: Failed to maintain a valid noted, nonbanking activities will be License Number: 018007F. bond. Name: LCL America, Inc. conducted throughout the United States. License Number: 001199N. Address: 29 Burgess Drive, Glendale Additional information on all bank Name: Suarez Shipping Services, Inc. holding companies may be obtained Heights, IL 60139. Address: 7819 W. 18th Lane, Hialeah, Date Revoked: April 30, 2004. from the National Information Center FL 33014. Reason: Failed to maintain a valid website at www.ffiec.gov/nic/. Date Revoked: March 23, 2004. bond. Unless otherwise noted, comments Reason: Surrendered license regarding each of these applications License Number: 004179NF. voluntarily. must be received at the Reserve Bank Name: Lilly & Associates- License Number: 017206NF. indicated or the offices of the Board of International Freight Forwarders, Inc. Name: Trade Impact, LLC dba Tacoma Governors not later than June 18, 2004. Address: 9601 NW 33rd Street, Logistics. A. Federal Reserve Bank of Cleveland Miami, FL 33172. Address: 1127 Broadway, Suite 203, (Nadine W. Wallman, Assistant Vice Date Revoked: April 30, 2004. Tacoma, WA 98402. President) 1455 East Sixth Street, Reason: Failed to maintain valid Date Revoked: May 7, 2004. Cleveland, Ohio 44101–2566: bonds. Reason: Failed to maintain valid 1. Camco Financial Corporation, License Number: 016297NF. bonds. Cambridge, Ohio; to become a bank Name: Multitrans, Inc. holding company by acquiring 100 Sandra L. Kusumoto, Address: 2103 NW. 79th Avenue, percent of the voting shares of London Miami, FL 33122. Director, Bureau of Consumer Complaints Financial Corporation, and thereby and Licensing. Date Revoked: April 30, 2004. indirectly acquire The Citizens Bank of Reason: Failed to maintain valid [FR Doc. 04–11921 Filed 5–25–04; 8:45 am] London, both of London, Ohio. bonds. BILLING CODE 6730–01–P B. Federal Reserve Bank of Atlanta License Number: 004672F. (Sue Costello, Vice President) 1000 Name: National Bonded Warehouse, Peachtree Street, N.E., Atlanta, Georgia FEDERAL RESERVE SYSTEM Inc. dba National Freight Express. 30303: Address: 11451 NW. 36th Avenue, Formations of, Acquisitions by, and 1. Piedmont Bancshares, Inc., Atlanta, Miami, FL 33167. Mergers of Bank Holding Companies Georgia; to become a bank holding Date: April 30, 2004. company by acquiring 100 percent of Reason: Failed to maintain a valid The companies listed in this notice the voting shares of Piedmont Bank of bond. have applied to the Board for approval, Georgia, Atlanta, Georgia.

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C. Federal Reserve Bank of Dallas 1. Hopkins Financial Corporation, Applications that fail to meet the (W. Arthur Tribble, Vice President) 2200 Mitchell, South Dakota; to engage de screening criteria described below will North Pearl Street, Dallas, Texas 75201– novo in lending activities, pursuant to not be reviewed and will receive no 2272: section 225.28(b)(1) of Regulation Y. further consideration: 1. Central Texas Bankshare Holdings, Board of Governors of the Federal Reserve 1. Postmark Requirements— Inc., Columbus, Texas, and Colorado System, May 20, 2004. Applications must be postmarked by County Investment Holdings, Inc., Robert deV. Frierson, midnight of the deadline date indicated Wilmington, Delaware; to acquire 45.33 Deputy Secretary of the Board. below, or hand-delivered by 5:30 p.m., percent of the voting shares of Hill Eastern Time, on that date, or submitted [FR Doc.04–11845 Filed 5–25–04; 8:45 am] Bancshares Holdings, Inc., Weimar, electronically by midnight on that date. BILLING CODE 6210–01–S Texas, and thereby indirectly acquire 2. Organizational Eligibility—Public voting shares of Hill Bancshares, Inc., and/or nonprofit agencies and Wilmington, Delaware, and Hill Bank & organizations, including faith-based DEPARTMENT OF HEALTH AND Trust Company, Weimar, Texas. organizations and community-based HUMAN SERVICES Board of Governors of the Federal Reserve organizations, with a proven record of System, May 20, 2004. Administration on Aging advising and representing individuals Robert deV. Frierson, who have been denied employer or Deputy Secretary of the Board. [Program Announcement No. AoA–04–03] union-sponsored pensions or other retirement savings plan benefits, are [FR Doc. 04–11846 Filed 5–25–04; 8:45 am] Fiscal Year 2004 Program eligible to apply under this program BILLING CODE 6210–01–S Announcement; Availability of Funds announcement. and Notice Regarding Applications 3. Responsiveness to Priority Area FEDERAL RESERVE SYSTEM AGENCY: Administration on Aging, HHS. Description—Applications will be ACTION: Announcement of availability of screened on whether the application is Notice of Proposals to Engage in funds and request for applications to responsive to the priority area Permissible Nonbanking Activities or support regional projects under the description. to Acquire Companies that are Pension Counseling and Information 4. Project Narrative—The Project Engaged in Permissible Nonbanking Program. Narrative section of the application Activities must not exceed 20 pages. The companies listed in this notice SUMMARY: The Administration on Aging Review of applications: Applications have given notice under section 4 of the announces that under this program will be evaluated against the following Bank Holding Company Act (12 U.S.C. announcement it will hold a criteria: Purpose and Need for 1843) (BHC Act) and Regulation Y (12 competition for grant awards for up to Assistance (20 points); Approach, Work CFR Part 225) to engage de novo, or to three (3) projects at a federal share of Plan and Activities (30 points); Project acquire or control voting securities or approximately $150,000 per year for a Outcomes, Evaluation and assets of a company, including the project period of up to three years. It is Dissemination (30 points); and Level of companies listed below, that engages estimated that approximately $450,000 Effort (20 points). will be available for this competition. either directly or through a subsidiary or DATES: The deadline date for the other company, in a nonbanking activity Legislative authority: The Older submission of applications is July 12, that is listed in § 225.28 of Regulation Y Americans Act, Public Law 106–501. 2004. (12 CFR 225.28) or that the Board has (Catalog of Federal Domestic Assistance determined by Order to be closely 93.048, Title IV and Title II, Discretionary ADDRESSES: Application kits are related to banking and permissible for Projects). available by writing to the U.S. bank holding companies. Unless Purpose of grant awards: The purpose Department of Health and Human otherwise noted, these activities will be of these projects is to assist individuals Services, Administration on Aging, conducted throughout the United States. in understanding and enforcing their Office of Consumer Choice and Each notice is available for inspection pension rights. Protection, Washington, DC 20201, by at the Federal Reserve Bank indicated. Eligibility for grant awards and other calling 202/357–3531, or online at http:/ The notice also will be available for requirements: Eligibility for grant /www.grants.gov. inspection at the offices of the Board of awards is limited to public and/or Applications may be mailed to the Governors. Interested persons may nonprofit agencies and organizations, U.S. Department of Health and Human express their views in writing on the including faith-based organizations and Services, Administration on Aging, question whether the proposal complies community-based organizations, with a Office of Grants Management, with the standards of section 4 of the proven record of advising and Washington, D.C. 20201, attn: Margaret BHC Act. Additional information on all representing individuals who have been Tolson (AoA–04–03). bank holding companies may be denied employer or union-sponsored Applications may be delivered to the obtained from the National Information pensions or other retirement savings U.S. Department of Health and Human Center website at www.ffiec.gov/nic/. plan benefits. Services, Administration on Aging, Unless otherwise noted, comments Grantees are required to provide at Office of Grants Management, One regarding the applications must be least 25 percent of the total program Massachusetts Avenue, NW., Room received at the Reserve Bank indicated costs from non-federal cash or in-kind 4604, Washington, DC 20001, attn: or the offices of the Board of Governors resources in order to be considered for Margaret Tolson (AoA–04–03). If you not later than June 9, 2004. the award. elect to mail or hand deliver your A. Federal Reserve Bank of Executive Order 12372 is not application you must submit one Minneapolis (Jacqueline G. Nicholas, applicable to these grant applications. original and two copies of the Community Affairs Officer) 90 Screening criteria: All applications application; an acknowledgement card Hennepin Avenue, Minneapolis, will be screened to assure a level will be mailed to applicants. Minnesota 55480–0291: playing field for all applicants. Instructions for electronic mailing of

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grant applications are available at http:/ Activities: Awardee activities for this the determination that continued /www.grants.gov/. program are as follows: Applicants funding is in the best interest of the SUPPLEMENTARY INFORMATION: All grant should provide evidence of the capacity Federal government. to effectively address the following applicants must obtain a D–U–N–S III. Eligibility Information number from Dun and Bradstreet. It is activities: a nine-digit identification number, a. Evaluate the effectiveness of III.1. Eligible Applicants which provides unique identifiers of education materials previously Assistance will be provided only to single business entities. The D–U–N–S developed for supplementation by applicants that are well-established number is free and easy to obtain from assessing reported knowledge, national, nonprofit organizations with _ http://www.dnb.com/US/duns update/. consumption and subsequent pregnancy state chapters that have expertise in: (1) outcomes of the target audience. FOR FURTHER INFORMATION CONTACT: U.S. Developing health education messages b. Develop training for health care Department of Health and Human for women at risk of having a NTD- providers (HCP) designed to increase Services, Administration on Aging, affected pregnancy; (2) developing State the number of women receiving Office of Grants Management, chapters to improve the health of counseling about consuming adequate Washington, DC 20201, telephone: (202) individuals with spina bifida and their levels of folic acid. 357–3440. families; and (3) developing a central c. Develop and implement a plan to resource information and education Dated: May 20, 2004. evaluate the efficacy and effectiveness center about spina bifida. Josefina G. Carbonell, of this project. To be eligible, applicants must: Assistant Secretary for Aging. d. Implement a pilot program to support the development of 1. Demonstrate that the organization’s [FR Doc. 04–11823 Filed 5–25–04; 8:45 am] mission is explicitly committed to the BILLING CODE 4154–01–P competencies among professionals in developing proposals for submission to prevention of NTDs specifically spina Federal and other funding agencies to bifida, and the health and well being of DEPARTMENT OF HEALTH AND further spina bifida research consistent individuals with spina bifida and their HUMAN SERVICES with evidence-based research priorities. families as demonstrated by submission e. Evaluate the effectiveness of the of the charter, articles of incorporation, Centers for Disease Control and pilot development program designed to or other governing documents. Prevention develop competency in professionals 2. Demonstrate that the organization related to proposal development for is a nonprofit and recognized as tax National Spina Bifida Information and research in spina bifida. exempt under section 501(c)(3) of the Resource Development Center f. Implement and evaluate a program Internal Revenue Code, and this may be for self-determination to improve the demonstrated through inclusion of your Announcement Type: New. Internal Revenue Service determination Funding Opportunity Number: 04215. quality of life of individuals with spina bifida and their families. letter. Catalog of Federal Domestic 3. Demonstrate the organization has Assistance Number: 93.283. g. Expand a national resource center for spina bifida information and capacity and experience in providing Dates: health education to women who are at Letter of Intent Deadline: June 10, dissemination. risk of having a NTD-affected 2004. h. Develop an evaluation plan for pregnancy, and this may be Application Deadline: June 25, 2004. tracking the volume, kinds of requests, and responses to requests and inquiries demonstrated through letters of support. I. Funding Opportunity Description made to the Resource Center for use in 4. Demonstrate that the organization enhancing the effectiveness and has a national membership and a Authority: This program is authorized responsiveness of the Center. national network of State and local under section 317(k)(2) of the Public Health chapters; this may be done through a Service Act, (42 U.S.C. 247b(k)(2)), as II. Award Information letter from the organization’s leadership amended. Type of Award: Grant. which describes the national network. Purpose: The purpose of the program Fiscal Year Funds: Fiscal Year 2004. 5. Demonstrate the presence and is to prevent the recurrence of Approximate Total Funding: functions of a national information and pregnancies affected by Neural Tube $950,000. resource center that is capable of Defects (NTDs), expand local programs Approximate Number of Awards: expansion. for those affected by spina bifida, One. This information should be placed promote research proposal development Approximate Average Award: directly behind the face page (first page) (not implementation), and expand $950,000. This amount is for the first of your application. Applications that information resources. 12-month budget period, and includes do not include the above information This program addresses the ‘‘Healthy both direct and indirect costs. will be determined as non-responsive People 2010’’ focus area(s) of Maternal, Floor of Award Range: Minimum and will be returned without review. Infant and Child Health and Disability award $900,000. and Secondary Conditions. Ceiling of Award: $950,000. III.2. Cost Sharing or Matching Measurable outcomes of the program Anticipated Award Date: September Matching funds are not required for will be in alignment with one (or more) 1, 2004. this program. of the following performance goal(s) for Budget Period Length: 12 months. the National Center on Birth Defects and Project Period Length: Two years. III.3. Other Developmental Disabilities: increasing Throughout the project period, CDC’s If you request a funding amount consumption of folic acid among commitment to continuation of awards greater than the ceiling of the award women of reproductive age to prevent will be conditioned on the availability range, your application will be serious birth defects, improving care, of funds, evidence of satisfactory considered non-responsive, and will not and improving the lives of people with progress by the recipient (as be entered into the review process. You spina bifida. documented in required reports), and will be notified that your application

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did not meet the submission • Printed only on one side of page, of interest in this program, and to allow requirements. double spaced. CDC to plan the application review. If your application is incomplete or • Held together only by rubber bands Application Deadline Date: June 25, non-responsive to the requirements or metal clips; not bound in any other 2004. listed in this section, it will not be way. Explanation of Deadlines: entered into the review process. You Your narrative should address Applications must be received in the will be notified that your application activities to be conducted over the CDC Procurement and Grants Office by did not meet submission requirements. entire project period, and must include 4 p.m. eastern time on the deadline date. If you send your application by the Note: Title 2 of the United States Code the following items which correspond to section 1611 states that an organization the evaluation criteria: Plan, Methods, United States Postal Service or described in section 501(c)(4) of the Internal Objectives, Timeline, Staff, commercial delivery service, you must Revenue Code that engages in lobbying Understanding, Need, Performance ensure that the carrier will be able to activities is not eligible to receive Federal Measures, Budget Justification, etc. The guarantee delivery of the application by funds constituting an award, grant, or loan. budget justification will not be counted the closing date and time. If CDC against the stated page limit. receives your application after closing IV. Application and Submission Additional information may be due to: (1) Carrier error, when the Information included in the application appendices. carrier accepted the package with a IV.1. Address To Request Application The appendices will not be counted guarantee for delivery by the closing Package toward the narrative page limit. This date and time, or (2) significant weather additional information may include: delays or natural disasters, you will be To apply for this funding opportunity curriculum vitae, resumes, given the opportunity to submit use application form PHS 5161. organizational charts, letters of support, documentation of the carriers guarantee. Application forms and instructions are graphic presentations of time-bounded If the documentation verifies a carrier available on the CDC Web site, at the work plans, etc. problem, CDC will consider the following Internet address: http:// Applicants must submit a separate application as having been received by www.cdc.gov/od/pgo/forminfo.htm. the deadline. If you do not have access to the typed abstract of their proposal consisting of no more than two single- This announcement is the definitive Internet, or if you have difficulty guide on application submission accessing the forms on-line, you may spaced pages. Applicants should also include a table of contents for the address and deadline. It supersedes contact the CDC Procurement and information provided in the application Grants Office Technical Information project narrative and related attachments. instructions. If your application does Management Section (PGO–TIM) staff not meet the deadline above, it will not You are required to have a Dun and at: (770) 488–2700. Application forms be eligible for review, and will be Bradstreet Data Universal Numbering can be mailed to you. discarded. You will be notified that System (DUNS) number to apply for a your application did not meet the IV.2. Content and Form of Submission grant or cooperative agreement from the submission requirements. Letter of Intent (LOI): CDC requests Federal government. The DUNS number CDC will not notify you upon receipt that you send a LOI if you intend to is a nine-digit identification number, of your application. If you have a apply for this program. Your LOI will be which uniquely identifies business question about the receipt of your used to gauge the level of interest in this entities. Obtaining a DUNS number is application, first contact your courier. If program, and to allow CDC to plan the easy, and there is no charge. you still have a question, contact the application review. Your LOI must be To obtain a DUNS number, access the PGO–TIM staff at: (770) 488–2700. submitted in the following format: following Web site: http:// Before calling, please wait three days • Maximum number of pages: Two. www.dunandbradstreet.com or call 1– after the application deadline. This will • Font size: 12-point unreduced. 866–705–5711. allow time for applications to be • Single-spaced. For more information, see the CDC processed and logged. • Paper size: 8.5 by 11 inches. Web site at: http://www.cdc.gov/od/pgo/ • Page margin size: One inch. funding/pubcommt.htm. IV.4. Intergovernmental Review of • Printed only on one side of page. If your application form does not have Applications • Written in plain language, avoid a DUNS number field, please write your Your application is subject to jargon. DUNS number at the top of the first Intergovernmental Review of Federal Content: Your LOI must contain the page of your application, and/or include Programs, as governed by Executive following information: Name, address, your DUNS number in your application Order (EO) 12372. This order sets up a and telephone number of the Principal cover letter. system for State and local governmental Investigator; names of other key Additional requirements that may review of proposed Federal assistance personnel; participating institutions; require you to submit additional applications. You should contact your number and title of the program documentation with your application State single point of contact (SPOC) as announcement. are listed in section ‘‘VI.2. early as possible to alert the SPOC to Application: You must submit a Administrative and National Policy prospective applications, and to receive project narrative with your application Requirements.’’ instructions on your State’s process. forms. The narrative must be submitted IV.3. Submission Dates and Times Click on the following link to get the in the following format: current SPOC list: http:// • Maximum number of pages: 35. If LOI Deadline Date: June 10, 2004. www.whitehouse.gov/omb/grants/ your narrative exceeds the page limit, CDC requests that you send a LOI if spoc.html. only the first pages which are within the you intend to apply for this program. page limit will be reviewed. Although the LOI is not required, not IV.5. Funding Restrictions • Font size: 12 point unreduced. binding, and does not enter into the Restrictions, which must be taken into • Paper size: 8.5 by 11 inches. review of your subsequent application, account while writing your budget, are • Page margin size: One inch. the LOI will be used to gauge the level as follows: Grant funds may be used to

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support personnel services, supplies, 1. Scope of Proposal (30 Points) ongoing activities implemented over the equipment, travel, subcontracts, and This addresses the applicant’s life of the project. other services directly related to project capacity to fully and effectively carry 6. Budget (Not Scored) activities consistent with the approved out project activities on a national scale scope of work. Grant funds cannot be as noted in the Announcement. This How well does the applicant provide used to supplant other available includes how well the activities justification for budget expenditures as applicant or collaborating agency funds, proposed will achieve project goals and well as appropriateness to activities for construction, for purchase of how the applicant anticipates and proposed in the application? The budget facilities or space, or for patient care. utilizes innovative and valued will be evaluated for the extent that it Grant funds cannot be used for approaches in meeting all requirements is reasonable, clearly justified, and individualized services (direct patient of the Announcement. This also consistent with the intended use of the support) such as for wheelchairs, includes how well the applicant grant funds. medical appliances, or assistive accounts for working with collaborating V.2. Review and Selection Process technology unless specifically approved entities and partners toward meeting the Applications will be reviewed for by the funding agency. Grant funds purpose of the project. cannot be used for the conduct of completeness by the Procurement and research. 2. Description of Objectives (25 Points) Grants Office (PGO) staff, and for If you are requesting indirect costs in This assesses whether the proposed responsiveness by the National Center your budget, you must include a copy goals and objectives are clearly stated, on Birth Defects and Developmental of your indirect cost rate agreement. If realistic, time-phased, adequately Disabilities. Incomplete applications your indirect cost rate is a provisional detailed, capable of tracking, and related and applications that are non- rate, the agreement should be less than to the purpose of the project. It includes responsive to the eligibility criteria will 12 months of age. how well the goals and objectives not advance through the review process. Guidance for completing your budget encompass all relevant components of Applicants will be notified that their can be found on the CDC Web site, at the work required under the application did not meet submission the following Internet address: http:// Announcement with attention to requirements. www.cdc.gov/od/pgo/funding/ individual, interdependent, and An objective review panel will budgetguide.htm. synergistic relationships among all evaluate complete and responsive IV.6. Other Submission Requirements elements of the Program Requirements. applications according to the criteria listed in the ‘‘V.1. Criteria’’ section LOI Submission Address: Submit your 3. Project Personnel (20 Points) above. LOI by express mail, delivery service, This includes an evaluation as to V.3. Anticipated Award Date fax, or e-mail to: Lisa T. Garbarino, whether all personnel proposed to be Public Health Analyst, National Center involved in this project are fully September 1, 2004. on Birth Defects, and Developmental qualified, with evidence of experience VI. Award Administration Information Disabilities, 1600 Clifton Road, and evidence in past activities and Mailstop: E–87, Atlanta, GA 30333. achievements appropriate to a project of VI.1. Award Notices Telephone (404) 498–3979, fax (404) this magnitude and scope. It also Successful applicants will receive a 498–3060, e-mail: [email protected]. includes whether the stated Application Submission Address: Notice of Grant Award (NGA) from the responsibilities for requested personnel CDC Procurement and Grants Office. Submit the original and two hard copies and the proposed staffing functions will of your application by mail or express The NGA shall be the only binding, assure adequate progress toward authorizing document between the delivery service to: Technical meeting all goals and objectives. Information Management—PA#04215, recipient and CDC. The NGA will be CDC Procurement and Grants Office, 4. Understanding of the Problem (15 signed by an authorized Grants 2920 Brandywine Road, Atlanta, GA Points) Management Officer, and mailed to the recipient fiscal officer identified in the 30341. This includes how well the applicant application. Applications may not be submitted demonstrates full understanding of the Unsuccessful applicants will receive electronically at this time. range of work requirements, potential notification of the results of the problems, and complexities of the V. Application Review Information application review by mail. project. It also covers how well the V.1. Criteria applicant provides background VI.2. Administrative and National You are required to provide measures information for the tasks envisioned Policy Requirements of effectiveness that will demonstrate such that framework and foundation 45 CFR Part 74 and Part 92 the accomplishment of the identified described directly demonstrates that the objectives of the grant. Measures of plan proposed to conduct the project For more information on the Code of effectiveness must relate to the will be effective and successful. Federal Regulations, see the National performance goals stated in the Archives and Records Administration at ‘‘Purpose’’ section of this 5. Evaluation (10 Points) the following Internet address: http:// announcement. Measures must be This includes the review of the www.access.gpo.gov/nara/cfr/cfr-table- objective and quantitative, and must applicant’s evaluation plan for the search.html. measure the intended outcome. These design and management of the The following additional measures of effectiveness must be individual and multiple initiatives requirements apply to this project: submitted with the application and will proposed in the conduct of the project. • AR–1 Human Subjects be an element of evaluation. This includes the funding agency’s Requirements. Each application will be evaluated review of the applicant’s planning • AR–2 Requirements for Inclusion individually against the following protocol for new activities as well as the of Women and Racial and Ethnic criteria by an independent review group applicant’s capacity to assess and Minorities in Research. appointed by CDC. monitor the performance and success of • AR–7 Executive Order 12372.

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• AR–8 Public Health System 2920 Brandywine Road, Suite 300, year old woman developed WNV Reporting Requirements. Atlanta, GA 30341. Telephone: (770) encephalitis during the 27th week of • AR–10 Smoke-Free Workplace 488–2771, e-mail: [email protected]. pregnancy. At 38 weeks of gestation she Requirements. Dated: May 20, 2004. delivered a live infant who appeared • AR–11 Healthy People 2010. William P. Nichols, normal but on further examination had • AR–12 Lobbying Restrictions. chorioretinitis and cystic cerebral tissue • AR–14 Accounting System Acting Director, Procurement and Grants Office, Centers for Disease Control and destruction. Tests for cytomegalovirus, Requirements. Prevention. rubella virus, herpes simplex virus, • AR–15 Proof of Non-Profit Status. [FR Doc. 04–11871 Filed 5–25–04; 8:45 am] lymphocytic choriomeningitis virus, • AR–22 Research Integrity. enterovirus, and toxoplasma provided BILLING CODE 4183–18–P • AR–24 Health Insurance no evidence that any of these agents had Portability and Accountability Act infected the infant. IgM antibody to Requirements. DEPARTMENT OF HEALTH AND WNV was found in cord blood and in • AR–25 Release and Sharing of HUMAN SERVICES the infant’s serum and cerebrospinal Data. fluid, indicating that the infant had Additional information on these Centers for Disease Control and acquired WNV infection in utero. WNV requirements can be found on the CDC Prevention nucleic acid was found in the placenta Web site at the following Internet and umbilical cord tissue. Although it is address: http://www.cdc.gov/od/pgo/ Study Effect of West Nile Virus not possible to establish a direct link funding/ARs.htm. Infection on Outcomes of Pregnancy in between WNV and the abnormalities VI.3. Reporting Humans seen in this infant, the abnormalities observed are consistent with those You must provide CDC with an Announcement Type: New. Funding Opportunity Number: 04213. observed in intrauterine infections with original, plus two hard copies of the other agents, suggesting that they may following reports: Catalog of Federal Domestic Assistance Number: 93.283. be related to WNV intrauterine 1. Interim progress report, no less infection. Three other instances of than 90 days before the end of the Key Dates: Letter of Intent Deadline: June 15, maternal WNV infection were budget period. The progress report will investigated in 2002; in all three serve as your non-competing 2004. Application Deadline: July 6, 2004. instances the infants were born at full continuation application, and must term with normal appearance and contain the following elements: I. Funding Opportunity Description without laboratory evidence of WNV a. Current Budget Period Activities infection, but cranial imaging studies Objectives. Authority: This program is authorized and ophthalmologic examinations were b. Current Budget Period Financial under section 317(k)(2) of the Public Health not performed. Progress. Service Act, (42 U.S.C. 247b(k)(2)), as c. New Budget Period Program amended. During 2002 a total of 4,156 cases of Proposed Activity Objectives. Purpose and Research Objectives: The WNV illness in humans, including d. Budget. purpose of the program is to determine 2,942 cases of neuroinvasive disease, e. Additional Requested Information. whether West Nile Virus (WNV) were reported to the Centers for Disease f. Measures of Effectiveness. infection of pregnant women has Control and Prevention (CDC) from state 2. Financial status report and annual adverse effects on the outcomes of health departments. During 2003 over progress report, no more than 90 days pregnancy and to measure and describe 9,100 cases of WN illness, including after the end of the budget period. the effects, if any, on the health of over 2,600 cases of neuroinvasive 3. Final financial and performance children born to women who were disease were reported to CDC. CDC is reports, no more than 90 days after the infected with WNV during their currently following over 70 women who end of the project period. pregnancy. were reported to have had WNV disease These reports must be mailed to the This program addresses the ‘‘Healthy during pregnancy in 2003. Grants Management or Contract People 2010’’ focus area of The proportion of WNV infections Specialist listed in the ‘‘Agency Immunization and Infectious Diseases. during pregnancy that result in Contacts’’ section of this announcement. Measurable outcomes of the program congenital infection of the newborn is will be in alignment with the following unknown. The spectrum of clinical VII. Agency Contacts performance goal for the National abnormalities associated with For general questions about this Center on Birth Defects and intrauterine infections with other agents announcement, contact: Technical Developmental Disabilities: To improve is wide and includes embryonic death Information Management Section, CDC the understanding and find the causes and resorption, abortion and stillbirth, Procurement and Grants Office, 2920 and risk factors for birth defects and prematurity, intrauterine growth Brandywine Road, Atlanta, GA 30341. developmental disabilities in order to retardation and low birth weight, Telephone: (770) 488–2700. develop prevention strategies. developmental anomalies and For program technical assistance, WNV, a single-stranded RNA teratogenesis, congenital disease, and contact: Lisa T. Garbarino, Public Health flavivirus with antigenic similarities to persistent postnatal infection. The case Analyst, National Center on Birth Japanese encephalitis and St. Louis described above from 2002 suggests that Defects and Developmental Disabilities, encephalitis viruses, is transmitted to intrauterine transmission of WNV in CDC, 1600 Clifton Road, Mailstop E–87, humans primarily through the bite of some instances may have deleterious Atlanta, GA 30333. Telephone: (404) infected mosquitoes. Flavivirus consequences, but the spectrum of 498–3979, e-mail: [email protected]. infection during pregnancy has been abnormalities and degree of risk of For financial, grants management, or rarely associated with both spontaneous intrauterine transmission are currently budget assistance, contact: Sylvia abortion and neonatal illness, and these unknown. Improved understanding of Dawson, Grants Management Specialist, viruses have not been known to cause these issues is essential to allow Procurement and Grants Office, CDC, birth defects in humans. In 2002, a 20- appropriate counseling of women

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exposed to WNV and to fully appreciate during the first trimester of their be effected by a Coordination the impact of this emerging infection. pregnancy should receive the evaluation Committee consisting of the Principal In December of 2003, the Division of recommended for infants suspected to Investigator from the participating Vector-Borne Infectious Diseases have congenital WNV infection, subject institution and the CDC Scientific (DVBID) of the National Center for to consent of the parents. Infants born Liaisons. This Coordinating Committee Infectious Diseases (NCID), and the to women suspected to have been will formulate a plan for cooperative Division of Birth Defects and infected with WNV during the second or research. Developmental Disabilities (DBDDD) of third trimester of pregnancy should be At periodic coordination committee the National Center on Birth Defects and evaluated as indicated in the interim meetings, the group will: (1) Make Developmental Disabilities (NCBDDD) guidelines mentioned above. More recommendations on the study protocol sought the opinion of experts on the detailed evaluation may be proposed by and data collection approaches; (2) evaluation of congenital infections to the recipient subject to ethical human discuss the target populations that have develop interim guidelines for the research review and approval of project been or will be recruited; (3) identify evaluation of infants born to mothers staff at DVBID and DBDDD. and recommend solutions to who were infected with WNV during (6) Publish and disseminate program unexpected study problems; and (4) their pregnancy. These guidelines results. discuss ways to efficiently coordinate included careful evaluation of physical CDC Responsibilities: In this study activities and best practices. characteristics, growth, development, cooperative agreement, CDC Scientists and hearing for these infants and (Scientific Liaisons) within the DBDDD/ II. Award Information ophthalmologic and dysmorphologic NCBDDD and the DVBID/NCID are an Type of Award: Cooperative evaluations and imaging of the brain for equal partner with scientific and agreement. CDC involvement in this infants with evidence of congenitally programmatic involvement during the program is listed in the Activities acquired WNV infection. Data obtained conduct of the project through technical Section above. from these evaluations will need to be assistance, advice, and coordination. Fiscal Year Funds: 2004. collected and carefully reviewed in These Scientific Liaisons will: Approximate Total Funding: order to better understand the effects of (1) Participate in the development of $350,000. WNV on pregnancy and infant the protocol. Approximate Number of Awards: outcomes. (2) Participate in the analysis, One. Activities: Recipient activities for this interpretation, and reporting of findings Approximate Average Award: program are as follows: in the scientific literature and other $350,000. (This amount is for the first (1) Develop a procedure for study media to the community at large and the 12-month budget period, and includes subject enrollment. Collaborate with public policy community within the both direct and indirect costs.) staff at DVBID and DBDDD to enroll Federal government. Floor of Award Range: None. (3) Participate in data management, women who have been infected with Ceiling of Award Range: $350,000 in analysis of data, and interpretation and WNV during pregnancy into the study initial budget period. If you request a using the WNV pregnancy registry dissemination of findings. (4) Provide scientific consultation and funding amount greater than the ceiling maintained by DVBID as a primary of the award range, your application source for enrollment. Additional technical assistance in the design and conduct of the project, including will be considered non-responsive, and sources of enrollment may be used upon will not be entered into the review mutual agreement between the recipient protocol adherence, outcome measures, and analytical approaches in process. You will be notified that your and CDC. application did not meet the submission (2) Develop a procedure for participation with the recipient organization. requirements. Based upon budget enrollment of pregnant women who constraints, requests for financial have not been infected with WNV to CDC Scientific Program Administrator assistance are subject to reduction in serve as study controls. (SPA) accordance with available resources. (3) Develop a study protocol detailing Anticipated Award Date: September the study design, sample size The CDC NCBDDD will appoint an SPA, apart from the NCBDDD and 1, 2004. calculations, study timeline, and Budget Period Length: 12 months. provisions to maintain confidentiality of DVBID Scientific Liaisons who will: (1) Serve as the Program Official for Project Period Length: Four years. study subjects. Throughout the project period, CDC’s (4) Ensure that all WNV-infected the funded research institutions. (2) Carry out continuous review of all commitment to continuation of awards women enrolled in the study have been activities to ensure objectives are being will be conditioned on the availability or are reported to the state health met. of funds, evidence of satisfactory department for the state in which they (3) Attend Coordination Committee progress by the recipient (as reside. meetings for purposes of assessing (5) Evaluate outcomes of all pregnant documented in required reports), and overall progress and for program the determination that continued women in the study to include evaluation purposes. documentation of complications of funding is in the best interest of the (4) Provide scientific consultation and Federal government. pregnancy, miscarriage, premature technical assistance in the conduct of delivery and health of live-born infants the project as requested. III. Eligibility Information according to the interim guidelines (5) Conduct site visits to recipient III.1. Eligible Applicants published in the Morbidity and institutions to determine the adequacy Mortality Weekly Report, Volume 53, of the research and to monitor Applications may be submitted by February 27, 2004, pages 154–157. performance against approved project public and private non-profit Because of uncertainty regarding objectives. organizations and by governments and diagnostic tests for congenital WNV their agencies, such as: infection; for purposes of this project, Collaborative Responsibilities • Public non-profit organizations. all infants born to women who were The planning and implementation of • Private non-profit organizations. suspected to be infected with WNV the cooperative aspects of the study will • Universities.

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• Colleges. information must be included as part of You must submit a signed original • Research Institutions. the application and inserted and five copies of your application • Hospitals. immediately after the Face Page of the form. The PHS 398 grant application • State and local governments or their application. form requires the applicant to enter the bona fide agents (this includes the Note: Title 2 of the United States Code project title on page 1 (Form AA, ‘‘Face District of Columbia, the Section 1611 states that an organization Page’’) and the project description Commonwealth of Puerto Rico, the described in Section 501(c)(4) of the Internal (abstract on page 2). Virgin Islands, the Commonwealth of Revenue Code that engages in lobbying The main body of the application the Northern Marianna Islands, activities is not eligible to receive Federal narrative should not exceed 30 single- American Samoa, Guam, the Federated funds constituting an award, grant, or loan. spaced pages. This narrative research States of Micronesia, the Republic of the plan should address activities to be Marshall Islands, and the Republic of IV. Application and Submission conducted over the entire project Palau). Information period. Please note that this maximum • Political subdivisions of States (in number of pages allowed exceeds the consultation with States). IV.1. Address To Request Application maximum number of pages (25 pages) A bona fide agent is an agency/ Package indicated in the PHS 398 grant organization identified by the State as To apply for this funding opportunity, application form (‘‘Research Grant Table eligible to submit an application under use application form PHS 398 (OMB of Contents’’). the State eligibility in lieu of a State number 0925–0001 rev. 5/2001). Forms Additional information may be application. If you are applying as a and instructions are available in an included in the application appendices. bona fide agent of a State or local interactive format on the CDC Web site, The appendices will not be counted government, you must provide a letter at the following Internet address: http: toward the narrative page limit. This from the State as documentation of your //www.cdc.gov/od/pgo/forminfo.htm. additional information may include status. Place this documentation behind Forms and instructions are also curriculum vitae and resumes for key the first page of the application form. available in an interactive format on the project staff, organizational charts, National Institutes of Health (NIH) Web letters of support, etc.; and should be III.2. Cost Sharing or Matching site at the following Internet address: limited to those items relevant to the Matching funds are not required for http://grants.nih.gov/grants/funding/ requirements of this announcement. this program. phs398/phs398.html. All material must be typewritten, with III.3. Other If you do not have access to the 10 characters per inch type (12 point) on Internet, or if you have difficulty 81⁄2 by 11 inch white paper with one Individuals Eligible to Become accessing the forms on-line, you may inch margins, no headers or footers Principal Investigators: Any individual contact the CDC Procurement and (except for applicant-produced forms with the skills, knowledge, and Grants Office Technical Information such as organizational charts, c. vitae, resources necessary to carry out the Management Section (PGO–TIM) staff graphs and tables, etc). Applications proposed research is invited to work at: 770–488–2700. Application forms must be held together only by rubber with their institution to develop an can be mailed to you. bands or metal clips, and not bound application for support. Individuals together in anyway (including IV.2. Content and Form of Submission from under-represented racial and attachments/appendices). ethnic groups as well as individuals Letter of Intent (LOI) You are required to have a Dun and with disabilities are always encouraged The LOI must be written in the Bradstreet Data Universal Numbering to apply for CDC programs. System (DUNS) number to apply for a Other Eligibility Requirements: If your following format: • Maximum number of pages: Two. grant or cooperative agreement from the application is incomplete or non- • Font size: 12-point unreduced. Federal government. Your DUNS responsive to the requirements listed • Paper size: 8.5 by 11 inches. number must be entered on line 11 of below, it will not be entered into the • Page margin size: One-inch the face page of the PHS 398 application review process. You will be notified that margins. form. The DUNS number is a nine-digit your application did not meet • Printed only on one side of page. identification number, which uniquely submission requirements. • Single spaced. identifies business entities. Obtaining a Applicants must: (1) Document their • Written in plain language; avoid DUNS number is easy and there is no present infrastructure, capacity, jargon. charge. To obtain a DUNS number, expertise, and experience in conducting The LOI must contain the following access http:// clinical and epidemiological evaluations information: name, address, and www.dunandbradstreet.com or call 1– of birth defects and/or infectious telephone number of the proposed 866–705–5711. For more information, diseases with a national sample; and (2) Principal Investigator, number and title see the CDC Web site at: http:// have in the past shown their ability to of this program announcement, names www.cdc.gov/od/pgo/funding/ identify and enroll women with West of other key personnel, designations of pubcommt.htm. Nile Virus or related birth defects and/ collaborating institutions and entities, Additional requirements that may or infectious diseases in studies related and an outline of the proposed work, require you to submit additional to infections during pregnancy and with recruitment approach, and expected documentation with your application related case controls. outcomes. are listed in section ‘‘VI.2. Applicants must provide specific Application: Follow the PHS 398 Administrative and National Policy evidence to substantiate this capacity, application instructions for content and Requirements.’’ experience, and expertise. Through formatting of your application. For documentation of two pages in length, further assistance with the PHS 398 IV.3. Submission Dates and Time applicants must provide specific application form, contact PGO–TIM staff Letter of Intent (LOI) Deadline Date: evidence that they can fully meet these at (770) 488–2700, or contact GrantsInfo, June 15, 2004. eligibility criteria in order to be telephone (301) 435–0714, e-mail: CDC requests that you send a LOI if considered for formal review. This [email protected]. you intend to apply for this program.

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Although the LOI is not required, not rate, the agreement must be less than 12 a. Identification of the problem and binding, and does not enter into the months from the application due date. justification for the study, including review of your subsequent application, accounts of understanding of West Nile IV.6. Other Submission Requirements the LOI will be used to gauge the level Virus and its association with human of interest in this program, and will LOI Submission Address illness, morbidity, and mortality; allow CDC to plan the application b. Accounts as to the level of review Lisa T. Garbarino, Public Health of relevant literature undertaken and the review. Analyst, National Center on Birth Application Deadline Date: July 6, discussion of the foundation in science Defects and Developmental Disabilities, 2004. being utilized in addressing the purpose Explanation of Deadlines: CDC, 1600 Clifton Road, Mailstop E–87, of the research; Applications must be received in the Atlanta, Georgia 30333. E-mail address: c. Description of the understanding of CDC Procurement and Grants Office by [email protected]. the implications and interrelationships 4 p.m. eastern time on the deadline Application Submission Address: between the vector and human host date. If you send your application by the Submit the original and five copies of responses; United States Postal Service or your application by mail or express d. Accounts of the applicants commercial delivery service, you must delivery service to: Technical understanding of the possible ensure that the carrier will be able to Information Management—PA, CDC association between West Nile Virus guarantee delivery of the application by Procurement and Grants Office, 2920 infection and outcomes of pregnancy in the closing date and time. If CDC Brandywine Road, Atlanta, Georgia humans; receives your application after closing 30341. e. Discussion of the unique due to: (1) Carrier error, when the Applications may not be submitted by capabilities residing in the applicant carrier accepted the package with a fax or e-mail at this time. organization in conducting clinical and epidemiological evaluations of birth guarantee for delivery by the closing V. Application Review Information date and time, or (2) significant weather defects and/or infectious diseases on a delays or natural disasters, you will be V.1. Review Criteria national basis; given the opportunity to submit f. Description of the study goals, You are required to provide measures objectives and/or hypotheses, and documentation of the carrier’s of outcome and effectiveness that will g. Intended use and applicability of guarantee. If the documentation verifies demonstrate the accomplishment of the study findings. a carrier problem, CDC will consider the various identified objectives of the 2. Research Approach and application as having been received by cooperative agreement. Measures of Organizational Capacity, including: the deadline. effectiveness must relate to the a. The overall strength and feasibility This announcement is the definitive performance goals stated in the of the research design with an emphasis guide on application submission ‘‘Purpose’’ section of this on pregnant women and the health of address and deadline. It supersedes announcement. Measures must be children born to women who were information provided in the application objective and quantitative, and must infected with West Nile Virus during instructions. If your application does measure the intended outcome. These pregnancy; not meet the deadline above, it will not measures of effectiveness must be b. Presentation of how the applicant be eligible for review, and will be submitted with the application and will is fully able to identify and enroll discarded. You will be notified that be an element of evaluation. women with West Nile Virus during your application did not meet the The goals of CDC-supported research pregnancy and related case controls; submission requirements. are to advance the understanding of c. Description and justification of the CDC will not notify you upon receipt biological systems, improve the control study population, including case of your application. If you have a and prevention of disease and injury, definitions, number of participants, question about the receipt of your and enhance health. In the written selection criteria, and methods for application, first contact your courier. If comments, reviewers will be asked to recruiting, enrolling, and sustaining you still have a question, contact the evaluate the application in order to participation; PGO–TIM staff at: 770–488–2700. Before judge the likelihood that the proposed d. Description of the consent process, calling, please wait three days after the research will have a substantial impact including procedures for informing application deadline. This will allow on the pursuit of these goals. The participants about the study and time for applications to be processed scientific review group will address the methods for obtaining consent; and logged. application’s overall score, weighting e. The detailed description of the research design and all follow-up IV.4. Intergovernmental Review of them as appropriate for each protocols, including access to a national Applications application. The application does not need to be strong in all categories to be sample; Executive Order 12372 does not apply f. Description of all study instruments judged likely to have major scientific to this program. including survey questionnaires, and a impact and thus deserve a high priority discussion of their reliability and IV.5. Funding Restrictions score. validity; Restrictions, which must be taken into Under the evaluation criteria noted g. Data handling and analysis plans, account while writing your budget are below, applicants must describe how including statistical methodology, data that project funds cannot be used to they will address the program entry, storage, and disposition; and supplant other available applicant or components as they relate to the h. Plans for disseminating and collaborating agency funds for Purpose and Research Objectives, and reporting results to multiple (and construction or for lease or purchase of Recipient Activities as cited in this applicant-identified) target audiences. facilities or space. Announcement. 3. Investigators/Collaborators/and If you are requesting indirect costs in Your application will be evaluated Management Plans, including: your budget, you must include a copy against the following criteria: a. Description of the major of your indirect cost rate agreement. If 1. Background/Understanding/ collaborators and their explicit your indirect cost rate is a provisional Competency, including: contributions to project objectives;

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b. Discussion of investigator(s) review process. Applicants will be Additional information on these qualifications, roles, tasks, time notified that their application did not requirements can be found on the CDC commitments, and responsibilities; and meet submission requirements and will Web site at the following Internet c. Detailed work plan with specific not receive further consideration. address: http://www.cdc.gov/od/pgo/ time frames for implementation of the Applications, which are complete and funding/ARs.htm. project. This includes the presentation responsive, will be subject to a VI.3. Reporting of overarching goals for the full four- preliminary evaluation (triage) by the year project period with a detailed work scientific review group (Special You must provide CDC with an plan outlining monthly or quarterly Emphasis Panel—SEP) to determine if original, plus two copies of the objectives covering the first two budget the application is of sufficient technical following reports: years. and scientific merit to warrant further 1. Interim progress report, (PHS 2590, 4. Evaluation Plan, including: review by the SEP. OMB Number 0925–0001, rev. 5/2001), a. Description of how progress will be Applications that are determined to on a date to be determined for your monitored and evaluated over the entire be non-competitive will not be project for each subsequent budget year. course of the research; considered, and the SEP will notify the The progress report will serve as your b. The extent to which project goals investigator/program director and the non-competing continuation are to be attained and specific objectives official signing for the applicant application, and must contain the accomplished; and organization. A dual review process will following elements: c. Description of expected outcomes then evaluate those applications a. Current Budget Period Activities and how the overall effectiveness of the determined to be competitive. and Objectives. research will be determined. b. Current Budget Period Financial 5. Budget Description and V.3. Anticipated Award Date Progress. Justification: This includes the September 1, 2004. comprehensiveness and adequacy of the c. New Budget Period Program proposed budget in relation to program VI. Award Administration Information Proposed Activities and Objectives. d. Budget. operations, collaborations, and services; VI.1. Award Notices and the extent to which the budget is e. Additional Requested Information. If your application is to be funded, reasonable, clearly justified, accurate, f. Measures of Effectiveness. you will receive a Notice of Grant and consistent with the purposes of this 2. Financial status report and annual Award (NGA) from the CDC research. report, no more than 90 days after the 6. Protections: Does the application Procurement and Grants Office. The end of the budget period. adequately address the requirements of NGA shall be the only binding, 3. Final financial and performance title 45 CFR part 46 for the protection authorizing document between the reports, no more than 90 days after the of human subjects? This criteria will not recipient and CDC. The NGA will be end of the project period. signed by an authorized Grants be scored; however, an application can These reports must be sent to the Management Officer, and mailed to the be disapproved if the research risks are Grants Management Specialist listed in recipient fiscal officer identified in the sufficiently serious and protection the ‘‘Agency Contacts’’ section of this application. Unsuccessful applicants against risks is so inadequate as to make announcement. the entire application unacceptable. will receive notification of the results of 7. Inclusion: Does the application the application review by mail. VII. Agency Contacts adequately address the CDC policy VI.2. Administrative and National For general questions about this requirements regarding the inclusion of Policy Requirements announcement, contact: Technical women, ethnic, and racial groups in the Information Management Section (PGO– proposed research? This includes: 45 CFR Parts 74 and 92 TIM), CDC Procurement and Grants a. The proposed plan for the inclusion For more information on the Code of Office, 2920 Brandywine Road, Atlanta, of both sexes and racial and ethnic Federal Regulations, see the National Georgia 30341. Telephone: 770–488– minority populations for appropriate Archives and Records Administration at 2700. representation. the following Internet address: http:// For program technical assistance, b.The proposed justification when www.access.gpo.gov/nara/cfr/cfr-table- contact: Lisa T. Garbarino, Public Health representation is limited or absent. search.html. Analyst, National Center on Birth c. A statement as to whether the The following additional Defects and Developmental Disabilities, design of the study is adequate to requirements apply to this project: CDC, 1600 Clifton Road, Mailstop E–87, measure differences when warranted. • AR–1 Human Subjects Atlanta, Georgia 30333. E-mail address: d. A statement as to whether the plans Requirements. [email protected]; telephone: 404–498–3979. • for recruitment and outreach for study AR–2 Requirement for Inclusion For financial, grant management, or participants include the process of of Women and Racial and Ethnic budget assistance, contact: Sylvia establishing partnerships with Minorities in Research. Dawson, Grants Management Specialist, • community(ies) and recognition of AR–9 Paperwork Reduction Act CDC Procurement and Grants Office, mutual benefits. Requirements. 2920 Brandywine Road, Atlanta, • AR–10 Smoke-Free Workplace V.2. Application Review Process Georgia 30341. Telephone: 770–488– Requirements. 2771; e-mail: [email protected]. Applications will be reviewed by CDC • AR–11 Healthy People 2010. staff for completeness by the • AR–12 Lobbying Restrictions. Dated: May 20, 2004. Procurement and Grants Office (PGO) • AR–14 Accounting Systems William P. Nichols, and for responsiveness by NCBDDD as Requirements. Acting Director, Procurement and Grants outlined in the ‘‘Other Eligibility • AR–15 Proof of Non-Profit Status. Office, Centers for Disease Control and Requirements’’. Incomplete applications • AR–22 Research Integrity. Prevention. and applications that are non- • AR–25 Release and Sharing of [FR Doc. 04–11872 Filed 5–25–04; 8:45 am] responsive will not advance through the Data. BILLING CODE 4163–18–P

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DEPARTMENT OF HEALTH AND announces the following council SUPPLEMENTARY INFORMATION section HUMAN SERVICES meeting. below. Although the Privacy Act Name: Advisory Council for the requires only that CMS provide an Centers for Disease Control and Elimination of Tuberculosis (ACET). opportunity for interested persons to Prevention Times and Dates: 8:30 a.m.–5 p.m., June comment on the proposed matching 23, 2004. 8:30 a.m.–12 p.m., June 24, 2004. program, CMS invites comments on all Healthcare Infection Control Practices Place: Corporate Square, Building 8, 1st portions of this notice. See EFFECTIVE Advisory Committee; Correction of Floor Conference Room, Atlanta, Georgia DATES section below for comment Notice of Meeting 30333. Telephone (404) 639–8008. period. Status: Open to the public, limited only by In accordance with section 10(a)(2) of the space available. The meeting room EFFECTIVE DATES: CMS filed a report of the Federal Advisory Committee Act accommodates approximately 100 people. the Computer Matching Program with (Pub. L. 92–463), the Centers for Disease Purpose: This council advises and makes the Chair of the House Committee on Control and Prevention (CDC) recommendations to the Secretary, Government Reform and Oversight, the announces the following committee Department of Health and Human Services; the Assistant Secretary for Health; and the Chair of the Senate Committee on meeting: Correction. Director, CDC, regarding the elimination of Governmental Affairs, and the ACTION: Notice; correction. tuberculosis (TB). Specifically, the Council Administrator, Office of Information makes recommendations regarding policies, and Regulatory Affairs, Office of SUMMARY: The Department of Health and strategies, objectives, and priorities; Management and Budget (OMB) on Human Services, Centers for Disease addresses the development and application April 30, 2004. We will not disclose any Control and Prevention published a of new technologies; and reviews the extent information under a matching document in the Federal Register of to which progress has been made toward agreement until 40 days after filing a May 18, 2004, concerning the eliminating TB. Matters To Be Discussed: Agenda items report to OMB and Congress or 30 days Healthcare Infection Control Practices after publication. We may defer Advisory Committee. include issues pertaining to TB Vaccine, TB Therapeutics and other TB-related topics. implementation of this matching Correction Agenda items are subject to change as program if we receive comments that In the Federal Register of May 18, priorities dictate. persuade us to defer implementation. Contact Person for More Information: ADDRESSES: The public should address 2004, (Volume 69, Number 96) [Notices] Paulette Ford-Knights, National Center for Page 28132–28133—‘‘Place: Swissotel, HIV, STD, and TB Prevention, 1600 Clifton comments to: Director, Division of 3391 Peachtree Road, NE., Atlanta, Road, NE., M/S E–07, Atlanta, Georgia 30333, Privacy Compliance Data Development Georgia 30033’’ should read: Westin telephone (404) 639–8008. (DPCDD), Enterprise Databases Group, Buckhead Hotel, 3391 Peachtree Road, The Director, Management Analysis and Office of Information Services (OIS), NE., Atlanta, Georgia 30033. Services Office, has been delegated the CMS, Mail stop N2–04–27, 7500 authority to sign Federal Register Notices FOR FURTHER INFORMATION CONTACT: Security Boulevard, Baltimore, pertaining to announcements of meetings and Maryland 21244–1850. Comments Michele L. Pearson, M.D., Executive other committee management activities, for Secretary, HICPAC, Division of received will be available for review at both CDC and the Agency for Toxic this location, by appointment, during Healthcare Quality Promotion, NCID, Substances and Disease Registry. CDC, 1600 Clifton Road, NE., M/S A–07, regular business hours, Monday through Atlanta, Georgia 30333, telephone (404) Alvin Hall, Friday from 9 a.m.–3 p.m., eastern time 498–1182. Director, Management Analysis and Services zone. The Director, Management Analysis Office, Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: and Services Office has been delegated Prevention. Maribel Franey, Health Insurance the authority to sign Federal Register [FR Doc. 04–11873 Filed 5–25–04; 8:45 am] Specialist, DPCDD, Enterprise Databases notices pertaining to announcements of BILLING CODE 4163–18–P Group, OIS, CMS, Mail stop N2–04–27, meetings and other committee 7500 Security Boulevard, N2–04–06, management activities, for both CDC Baltimore, Maryland 21244–1850. The DEPARTMENT OF HEALTH AND and the Agency for Toxic Substances telephone number is (410) 786–0757, or HUMAN SERVICES and Disease Registry. facsimile (410) 786–5636. SUPPLEMENTARY INFORMATION: Alvin Hall, Centers for Medicare & Medicaid Director, Management Analysis and Services Services I. Description of the Matching Program Office, Centers for Disease Control and Prevention. Privacy Act of 1974; Computer A. General [FR Doc. 04–11874 Filed 5–25–04; 8:45 am] Matching Program (Match No. 2001–04) The Computer Matching and Privacy BILLING CODE 4163–19–P AGENCY: Department of Health and Protection Act (CMPPA) of 1988 (Public Human Services (HHS), Centers for Law (Pub. L.) 100–503), amended the Medicare & Medicaid Services (CMS). Privacy Act (5 U.S.C. 552a) by DEPARTMENT OF HEALTH AND ACTION: Notice of computer matching describing the manner in which HUMAN SERVICES program. computer matching involving Federal agencies could be performed and adding Centers for Disease Control and SUMMARY: In accordance with the certain protections for individuals Prevention requirements of the Privacy Act of 1974, applying for and receiving Federal Advisory Council for the Elimination of as amended, this notice announces the benefits. Section 7201 of the Omnibus Tuberculosis establishment of a computer-matching Budget Reconciliation Act of 1990 (Pub. program that CMS plans to conduct L. 100–508) further amended the In accordance with section 10(a)(2) of with the Department of Defense (DoD). Privacy Act regarding protections for the Federal Advisory Committee Act We have provided background such individuals. The Privacy Act, as (Pub. L. 92–463), the Centers for Disease information about the proposed amended, regulates the use of computer Control and Prevention (CDC) matching program in the matching by Federal agencies when

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records in a system of records are disclose Medicare Part A entitlement months thereafter, if certain conditions matched with other Federal, State, or and Part B enrollment information to are met. local government records. It requires the Department of Defense (DoD), [FR Doc. 04–11937 Filed 5–25–04; 8:45 am] Federal agencies involved in computer Defense Manpower Data Center BILLING CODE 4120–03–P matching programs to: (DMDC), Defense Enrollment and 1. Negotiate written agreements with Eligibility Reporting System Office the other agencies participating in the (DEERS), and the Office of the Assistant DEPARTMENT OF HEALTH AND matching programs; Secretary of Defense (Health Affairs) / HUMAN SERVICES 2. Obtain the Data Integrity Boards TRICARE Management Activity (TMA). (DIB) approval of the match agreements; This disclosure will provide TMA with Food and Drug Administration 3. Furnish detailed reports about the information necessary to determine [Docket No. 2002D–0350] matching programs to Congress and if an individual is eligible to receive OMB; extended TRICARE coverage. Guidance for Industry on Handling and 4. Notify applicants and beneficiaries Current law requires TMA to provide Retention of Bioavailability and that the records are subject to matching; health care and medical benefits to Bioequivalence Testing Samples; and, Medicare eligible beneficiaries who are Availability 5. Verify match findings before enrolled in the medical insurance reducing, suspending, terminating, or program under Part B of the Medicare AGENCY: Food and Drug Administration, denying an individual’s benefits or program. In order for TMA to meet these HHS. payments. requirements, CMS agrees to disclose ACTION: Notice. Part A entitlement and Part B B. CMS Computer Matches Subject to SUMMARY: The Food and Drug the Privacy Act enrollment data on this dual eligible population, which will be used to Administration (FDA) is announcing the availability of a guidance for industry CMS has taken action to ensure that determine a beneficiary’s eligibility for entitled ‘‘Handling and Retention of BA all of the computer matches programs care under TRICARE. DEERS will and BE Testing Samples.’’ The guidance that this agency participates in comply receive the results of the computer is intended to provide recommendations with the requirements of the Privacy Act match and provide the information for study sponsors and/or drug of 1974, as amended. provided to TMA for use in its program. manufacturers, contract research Dated: May 20, 2004. CATEGORIES OF RECORDS AND INDIVIDUALS organizations, site management Mark B. McClellan, COVERED BY THE MATCH: organizations, clinical investigators, and Administrator. DEERS will furnish CMS with an independent third parties on the COMPUTER MATCH NO. 2001–04 electronic file on a monthly basis procedure for handling reserve samples extracted from DEERS’ system of from bioavailability (BA) and NAME: records identified as S322.50, entitled bioequivalence (BE) studies. The ‘‘Verification of TRICARE Eligibility’’. ‘‘Defense Eligibility Records (DER),’’ guidance clarifies how to distribute test containing social security numbers articles and reference standards to SECURITY CLASSIFICATION: (SSN) and date of birth for all DoD testing facilities, how to randomly select Level Three Privacy Act Sensitive. eligible beneficiaries whom may also be reserve samples, and how to retain reserve samples. PARTICIPATING AGENCIES: eligible for Medicare benefits. CMS will DATES: Submit written or electronic Centers for Medicare & Medicaid match the DEERS file against its comments on agency guidances at any Services (CMS); and Department of ‘‘Enrollment Database (EDB)’’ system of time. Defense (DoD). records (formerly known as the Health Insurance Master Record), System No. ADDRESSES: Submit written requests for AUTHORITY FOR CONDUCTING MATCHING 09–70–0502, and will validate the single copies of this guidance to the PROGRAM: identification of the beneficiary by Division of Drug Information (HFD– This Computer Matching Agreement providing the Health Insurance Claims 240), Center for Drug Evaluation and is executed to comply with the Privacy Number (HICN) that matches against the Research, Food and Drug Act of 1974 (5 U.S.C. 552a), as amended, SSN and date of birth provided by Administration, 5600 Fishers Lane, the Office of Management and Budget DEERS. CMS will also provide the Rockville, MD 20857. Send one self- (OMB) Circular A–130, entitled Medicare Part A entitlement and Part B addressed adhesive label to assist that ‘‘Management of Federal Information enrollment status of the beneficiary. office in processing your requests. Resources’’ (61 FR 6435, February 20, CMS’s data will help TMA to determine Submit written comments on the 1996), and OMB guidelines pertaining a beneficiary’s eligibility for care under guidance to the Division of Dockets to computer matching (54 FR 25818, TRICARE. DEERS will receive the Management (HFA–305), Food and Drug June 19, 1989). results of the computer match and Administration, 5630 Fishers Lane, rm. This agreement implements the provide the information provided in the 1061, Rockville, MD 20852. Submit information matching provisions of the reply file to TMA for use in its program. electronic comments to http:// National Defense Authorization Act INCLUSIVE DATES OF THE MATCH: www.fda.gov/dockets/ecomments. See (NDAA) for Fiscal Year (FY) 2001 the SUPPLEMENTARY INFORMATION section (Public Law (Pub. L.) 106–398) §§ 711 The Computer Matching Program shall become effective no sooner than 40 for electronic access to the guidance and 712; the NDAA for FY 1993 (Pub. document. L. 102–484) § 705, and the NDAA for FY days after the report of the Matching 1992 (Pub. L. 102–190 §§ 704 and 713). Program is sent to OMB and Congress, FOR FURTHER INFORMATION CONTACT: or 30 days after publication in the Martin Yau, Center for Drug Evaluation PURPOSE (S) OF THE MATCHING PROGRAM: Federal Register, which ever is later. and Research (HFD–45), Food and Drug The purpose of this agreement is to The matching program will continue for Administration, 5600 Fishers Lane, establish the conditions, safeguards and 18 months from the effective date and Rockville, MD 20857, 301–827–5458. procedures under which CMS will may be extended for an additional 12 SUPPLEMENTARY INFORMATION:

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I. Background found in brackets in the heading of this For further information contact: Anyone document. The guidance and received wishing to obtain a roster of members, FDA is announcing the availability of minutes of meetings, or other relevant a guidance for industry entitled comments are available for public examination in the Division of Dockets information should write or contact Stella ‘‘Handling and Retention of BA and BE Yu, Sc.D., M.P.H., Executive Secretary, Testing Samples.’’ Following the generic Management between 9 a.m. and 4 p.m., Maternal and Child Health Research Grants drug crisis in the 1980s, FDA issued Monday through Friday. Review Committee, Room 18A–55, Parklawn regulations to prevent possible bias and III. Electronic Access Building, 5600 Fishers Lane, Rockville, fraud in BA and BE testing by study Maryland 20857, Telephone (301) 443–0695. Persons with access to the Internet sponsors and/or drug manufacturers (58 Dated: May 19, 2004. may obtain the document at either http:/ FR 25918, April 28, 1993). In the Tina M. Cheatham, /www.fda.gov/cder/guidance/index.htm preamble to the final rule, the agency or http://www.fda.gov/ohrms/dockets/ Director, Division of Policy Review and stated that the study sponsor should not Coordination. default/htm. separate out the reserve samples of the [FR Doc. 04–11829 Filed 5–25–04; 8:45 am] Dated: May 18, 2004. test article and reference standard prior BILLING CODE 4165–15–P to sending the drug product to the Jeffrey Shuren, testing facility. This is to ensure that the Assistant Commissioner for Policy. reserve samples are in fact [FR Doc. 04–11828 Filed 5–25–04; 8:45 am] DEPARTMENT OF HEALTH AND representative of the same batches BILLING CODE 4160–01–S HUMAN SERVICES provided by the study sponsor for the testing. National Institutes of Health FDA’s Division of Scientific DEPARTMENT OF HEALTH AND Investigations and field investigators HUMAN SERVICES National Eye Institute; Notice of Closed from the Office of Regulatory Affairs Meeting conduct inspections of clinical and Health Resources and Services Pursuant to section 10(d) of the analytical sites that perform BA and BE Administration Federal Advisory Committee Act, as studies for sponsors and/or drug amended (5 U.S.C. Appendix 2), notice Maternal and Child Health Research manufacturers seeking approval of is hereby given of the following Grants Review Committee; Notice of generic and new drug products. A meeting. Meeting frequent finding from these inspections The meeting will be closed to the is the absence of reserve samples at the In accordance with section 10(a)(2) of public in accordance with the testing facility. In the Federal Register the Federal Advisory Committee Act provisions set forth in sections of August 21, 2002 (67 FR 54219), the (Pub. L. 92–463), notice is hereby given 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., agency issued a draft guidance entitled of the following meeting: as amended. The grant applications and ‘‘Handling and Retention of the discussions could disclose Bioavailability and Bioequivalence Name: Maternal and Child Health Research Grants Review Committee. confidential trade secrets or commercial Testing Samples’’ to clarify the Dates and Times: June 15 , 2004, 8:30 a.m. property such as patentable material, responsibilities of the involved parties to 9:30 a.m.—open, June 15, 2004, 9:30 a.m. and personal information concerning for retention of samples used in BA and to 5 p.m.—closed, June 16, 2004, 8:30 a.m. individuals associated with the grant BE studies. That draft guidance to 5 p.m.—closed, June 17, 2004, 8:30 a.m. applications, the disclosure of which included recommendations for sampling to 5 p.m.—closed. would constitute a clearly unwarranted techniques and responsibilities in Place: Hilton Garden Inn, 815 14th Street, invasion of personal privacy. various study settings. All comments NW., Washington, DC 20005. Status: The meeting will be open to the Name of Committee: National Eye Institute received during the comment period Special Emphasis Panel, Review of have been carefully reviewed and public on Tuesday, June 15, 2004, from 8:30 a.m. to 9:30 a.m. The remainder of the Conference Applications (R13s). changes were made to this final meeting will be closed to the public in Date: May 24, 2004. guidance where appropriate. accordance with provisions set forth in Time: 10 a.m. to 12 p.m. This guidance is being issued section 552b(c)(6), title 5 U.S.C., and the Agenda: To review and evaluate grant consistent with FDA’s good guidance Determination of the Acting Deputy applications. practices regulation (21 CFR 10.115). Associate Administrator for Management and Place: National Institutes of Health, 5635 Program Support, Health Resources and Fishers Lane, Bethesda, MD 20892. The guidance represents the agency’s Contact Person: Houmam H. Araj, PhD, current thinking on retention of BA and Services Administration (HRSA), pursuant to section 10(d) of the Federal Advisory Scientific Review Administrator, Division of BE testing samples. It does not create or Extramural Research, National Eye Institute, Committee Act (Pub. L. 92–463). confer any rights for or on any person NIH, 5635 Fishers Lane, Suite 1300, Purpose: To review research grant Bethesda, MD 20892–9602, 301–451–2020, and does not operate to bind FDA or the applications in the program areas of maternal [email protected]. public. An alternative approach may be and child health, administered by HRSA’s This notice is being published less than 15 used if such approach satisfies the Maternal and Child Health Bureau (MCHB). days prior to the meeting due to the timing requirements of the applicable statutes Agenda: The open portion of the meeting limitations imposed by the review and will cover opening remarks by the Director, and regulations. funding cycle. Division of Research, Training and II. Comments Education, MCHB, HRSA, who will report on (Catalogue of Federal Domestic Assistance program issues, congressional activities, and Program Nos. 93.867, Vision Research, Interested persons may submit to the National Institute of Health, HHS) Division of Dockets Management (see other topics of interest to the field of maternal and child health. The closed ADDRESSES) written or electronic Dated: May 18, 2004. portion of the meeting will involve the LaVerne Y. Stringfield, comments on the guidance at any time. review, discussion, and evaluation of grant Director, Office of Federal Advisory Two copies of any mailed comments are applications containing information of a Committee Policy. to be submitted, except that individuals personal nature, the disclosure of which may submit one copy. Comments are to would constitute a clearly unwarranted [FR Doc. 04–11836 Filed 5–25–04; 8:45 am] be identified with the docket number invasion of personal privacy. BILLING CODE 4140–01–M

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DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meeting will be closed to the HUMAN SERVICES as amended. The grant applications and public in accordance with the the discussions could disclose provisions set forth in sections National Institutes of Health confidential trade secrets or commercial 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., property such as patentable material, as amended. The grant applications and National Eye Institute; Notice of Closed and personal information concerning the discussions could disclose Meeting individuals associated with the grant confidential trade secrets or commercial Pursuant to section 10(d) of the applications, the disclosure of which property such as patentable material, Federal Advisory Committee Act, as would constitute a clearly unwarranted and personal information concerning amended (5 U.S.C. Appendix 2), notice invasion of personal privacy. individuals associated with the grant is hereby given of the following Name of Committee: National Heart, Lung, applications, the disclosure of which meeting. and Blood Institute Special Emphasis Panel, would constitute a clearly unwarranted The meeting will be closed to the Review of RFA–HL–04–010: Inter- invasion of personal privacy. public in accordance with the Relationships of Sleep, Fatigue, and HIV/ Name of Committee: National Institute of provisions set forth in sections AIDS. Nursing Research Initial Review Group. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: June 24, 2004. Date: June 15–16, 2004. Time: 8:30 a.m. to 12 p.m. as amended. The grant applications and Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant Agenda: To review and evaluate grant the discussions could disclose applications. applications. confidential trade secrets or commercial Place: Double Tree Rockville, 1750 Place: DoubleTree Hotel and Executive property such as patentable material, Rockville Pike, Rockville, MD 20852. Meeting Center, 1750 Rockville Pike, and personal information concerning Contact Person: Arthur N Freed, PhD, Rockville, MD 20852. individuals associated with the grant Review Branch, Room 7186, Division of Contact Person: Jeffrey M. Chernak, PhD, applications, the disclosure of which Extramural Affairs, National Heart, Lung, and Scientific Review Administrator, Office of Blood Institute, National Institutes of Health, would constitute a clearly unwarranted Review, National Institute of Nursing 6701 Rockledge Drive, MSC 7924, Bethesda, Research, 6701 Democracy Plaza, Suite 712, invasion of personal privacy. MD 20892, (301) 435–0280. MSC 4870, Bethesda, MD 20817, (301) 402– Name of Committee: National Eye Institute Name of Committee: National Heart, Lung, 6959, [email protected]. Special Emphasis Panel, Review of Mentored and Blood Institute Special Emphasis Panel, This notice is being published less than 15 Clinical Scientist Development Awards Review of RFA–HL–04–003: Cellular and days prior to the meeting due to the timing (K08s). Molecular Imaging of the Cardiovascular, limitations imposed by the review and Date: May 21, 2004. Pulmonary and Hematopoietic Systems. funding cycle. Time: 4:30 p.m. to 5:30 p.m. Date: June 24–25, 2004. (Catalogue of Federal Domestic Assistance Agenda: To review and evaluate grant Time: 7 a.m. to 5 p.m. Program Nos. 93.361, Nursing Research, applications. Agenda: To review and evaluate grant National Institutes of Health, HHS) Place: National Institutes of Health, 5835 applications. Fishers Lane, Bethesda, MD 20892 Place: Churchill Hotel, 1914 Connecticut Dated: May 19, 2004. (Telephone Conference Call). Avenue, NW., Washington, DC 20009. LaVerne Y. Stringfield, Contact Person: Samuel Rawlings, PhD, Contact Person: Keith A. Mintzer, PhD, Director, Office of Federal Advisory Chief, Scientific Review Branch, Division of Scientific Review Administrator, Review Committee Policy. Extramural Research, National Eye Institute, Branch, Division of Extramural Affairs, [FR Doc. 04–11832 Filed 5–25–04; 8:45 am] Bethesda, MD 20892, 301–451–2020. National Heart, Lung, and Blood Institute, This notice is being published less than 15 National Institutes of Health, 6701 Rockledge BILLING CODE 4140–01–M days prior to the meeting due to the timing Drive, Room 7186, MSC 7924, Bethesda, MD limitations imposed by the review and 20892, (301) 435–0280. funding cycle. (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for HUMAN SERVICES Program No. 93.867, Vision Research, Sleep disorders Research; 93.837, Heart and National Institutes of Health, HHS) Vascular Diseases Research; 93.838, Lung National Institutes of Health Dated: May 18, 2004. Diseases Research; 93.839, Blood Diseases National Institute on Drug Abuse; LaVerne Y. Stringfield, and Resources Research, National Institutes of Health, HHS) Notice of Closed Meetings Director, Office of Federal Advisory Committee Policy. Dated: May 19, 2004. Pursuant to section 10(d) of the [FR Doc. 04–11837 Filed 5–25–04; 8:45 am] LaVerne Y. Stringfield, Federal Advisory Committee Act, as BILLING CODE 4140–01–M Director, Office of Federal Advisory amended (5 U.S.C. Appendix 2), notice Committee Policy. is hereby given of the following [FR Doc. 04–11831 Filed 5–25–04; 8:45 am] meetings. DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–M The meetings will be closed to the HUMAN SERVICES public in accordance with the provisions set forth in sections National Institutes of Health DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., HUMAN SERVICES as amended. The grant applications and National Heart, Lung, and Blood the discussions could disclose Institute; Notice of Closed Meeting National Institutes of Health confidential trade secrets or commercial Pursuant to section 10(d) of the National Institute of Nursing Research; property such as patentable material, Federal Advisory Committee Act, as Notice of Closed Meeting and personal information concerning amended (5 U.S.C. Appendix 2), notice individuals associated with the grant is hereby given of the following Pursuant to section 10(d) of the applications, the disclosure of which meetings. Federal Advisory Committee Act, as would constitute a clearly unwarranted The meetings will be closed to the amended (5 U.S.C. Appendix 2), notice invasion of personal privacy. public in accordance with the is hereby given of the following Name of Committee: National Institute on provisions set forth in sections meeting. Drug Abuse Initial Review Group,

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Medication Development Research Screening and Intervention for Youth in Name of Committee: National Institute on Subcommittee. Primary Care Settings. Drug Abuse Special Emphasis Panel, Date: June 7, 2004. Date: July 7–8, 2004. ‘‘Neuroimaging Branch Support Services.’’ Time: 8 a.m. to 6 p.m. Time: 9 a.m. to 5 p.m. Date: June 9, 2004. Agenda: To review and evaluate grant Agenda: To review and evaluate grant Time: 9:30 a.m. to 4 p.m. applications. applications. Agenda: To review and evaluate contract Place: The Fairmont Washington, DC, 2401 Place: Hyatt Regency Bethesda, One proposals. M Street, NW, Washington, DC 20037. Bethesda Metro Center, 7400 Wisconsin Place: Radisson Plaza Lord Baltimore, 20 Contact Person: Khursheed Asghar, PhD, Avenue, Bethesda, MD 20814. West Baltimore Street, Baltimore, MD 21201. Chief, Basic Sciences Review Branch, Office Contact Person: Mark R. Green, PhD, Contact Person: Lyle Furr, Contract Review of Extramural Affairs, National Institute on Deputy Director, Office of Extramural Affairs, Specialist, Office of Extramural Affairs, Drug Abuse, NIH, DHHS, Room 220, MSC National Institute on Drug Abuse, NIH, National Institute on Drug Abuse, NIH, 8401, 6101 Executive Boulevard, Bethesda, DHHS, Room 220, MSC 8401, 6101 Executive DHHS, Room 220, MSC 8401, 6101 Executive MD 20892–8401, (301) 443–2755. Boulevard, Bethesda, MD 20892–8401, (301) Boulevard, Bethesda, MD 20892–8401, (301) This notice is being published less than 15 435–1431. 435–1439. days prior to the meeting due to the timing Name of Committee: National Institute on This notice is being published less than 15 limitations imposed by the review and Drug Abuse Special Emphasis Panel, Member days prior to the meeting due to the timing funding cycle. Conflict Meeting. limitations imposed by the review and Name of Committee: National Institute on Date: July 8, 2004. funding cycle. Drug Abuse Initial Review Group, Health Time: 5 p.m. to 8 p.m. Name of Committee: National Institute on Agenda: To review and evaluate grant Services Research Subcommittee. Drug Abuse Special Emphasis Panel, Date: June 8–9, 2004. applications. ‘‘Clinical Trials Network Clinical Laboratory Time: 8:30 a.m. to 5 p.m. Place: Ritz-Carlton Hotel at Pentagon City, Services.’’ Agenda: To review and evaluate grant 1250 South Hayes Street, Arlington, VA Date: June 9, 2004. applications. 22202. Time: 10 a.m. to 12 p.m. Place: Hyatt Regency Bethesda, One Contact Person: Eliane Lazar-Wesley, PhD, Bethesda Metro Center, 7400 Wisconsin Health Scientist Administrator, Office of Agenda: To review and evaluate contract Avenue, Bethesda, MD 20814. Extramural Affairs, National Institute on proposals. Contact: Mark R. Green, PhD, Chief, Drug Abuse, NIH, DHHS, Room 220, MSC Place: National Institutes of Health, 6101 CEASRB, Office of Extramural Affairs, 8401, 6101 Executive Boulevard, Bethesda, Executive Boulevard, Rockville, MD 20852 National Institute on Drug Abuse, NIH, MD 20892–8401, (301) 435–4530. (Telephone Conference Call). Contact Person: Richard C. Harrison, Chief, DHHS, Room 220, MSC 8401, 6101 Executive (Catalogue of Federal Domestic Assistance Contract Review Branch, Office of Extramural Boulevard, Bethesda, MD 20892–8401, (301) Program Nos. 93.277, Drug Abuse Scientist Affairs, National Institute on Drug Abuse, 435–1431. Development Award for Clinicians, Scientist NIH, DHHS, Room 220, MSC 8401, 6101 This notice is being published less than 15 Development Awards, and Research Scientist Executive Boulevard, Bethesda, MD 20892– days prior to the meeting due to the timing Awards; 93.278, Drug Abuse National 8401, 301–435–1437. limitations imposed by the review and Research Service Awards for Research This notice is being published less than 15 funding cycle. Training; 93.279, Drug Abuse Research days prior to the meeting due to the timing Name of Committee: National Institute on Programs, National Institutes of Health, HHS) limitations imposed by the review and Drug Abuse Initial Review Group, Treatment Dated: May 19, 2004. funding cycle. Research Subcommittee. Date: June 8–9, 2004. LaVerne Y. Stringfield, (Catalogue of Federal Domestic Assistance Time: 9 a.m. to 6 p.m. Director, Office of Federal Advisory Program Nos. 93.277, Drug Abuse Scientist Agenda: To review and evaluate grant Committee Policy. Development Award for Clinicians, Scientist applications. [FR Doc. 04–11833 Filed 5–25–04; 8:45 am] Development Awards, and Research Scientist Awards; 93.278, Drug Abuse National Place: Hyatt Regency Bethesda, One BILLING CODE 4140–01–M Bethesda Metro Center, 7400 Wisconsin Research Service Awards for Research Avenue, Bethesda, MD 20814. Training; 93.279, Drug Abuse Research Programs, National Institutes of Health, HHS) Contact Person: Kesinee Nimit, MD, Health DEPARTMENT OF HEALTH AND Scientist Administrator, Office of Extramural Dated: May 18, 2004. Affairs, National Institute on Drug Abuse, HUMAN SERVICES LaVerne Y. Stringfield, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892– National Institutes of Health Director, Office of Federal Advisory 8401, (301) 435–1432. Committee Policy. This notice is being published less than 15 National Institute on Drug Abuse; [FR Doc. 04–11834 Filed 5–25–04; 8:45 am] Notice of Closed Meetings days prior to the meeting due to the timing BILLING CODE 4140–01–M limitations imposed by the review and Pursuant to section 10(d) of the funding cycle. Federal Advisory Committee Act, as Name of Committee: National Institute on amended (5 U.S.C. Appendix 2), notice DEPARTMENT OF HEALTH AND Drug Abuse Initial Review Group, Training HUMAN SERVICES and Career Development Subcommittee. is hereby given of the following meetings. Date: July 7–9, 2004. National Institutes of Health Time: 9 a.m. to 6 p.m. The meetings will be closed to the Agenda: To review and evaluate grant public in accordance with the National Institute on Aging; Notice of applications. provisions set forth in sections Closed Meetings Place: Ritz-Carlton Hotel at Pentagon City, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 1250 South Hayes Street, Arlington, VA as amended. The contract proposals and Pursuant to section 10(d) of the 22202. the discussions could disclose Federal Advisory Committee Act, as Contact Person: Mark Swieter, PhD, Health confidential trade secrets or commercial amended (5 U.S.C. Appendix 2), notice Scientist Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, property such as patentable material, is hereby given of the following National Institutes of Health, DHHS, 6101 and personal information concerning meetings. Executive Boulevard, Suite 234, Bethesda, individuals associated with the contract The meetings will be closed to the MD 20892–8401, (301) 435–1389. proposals, the disclosure of which public in accordance with the Name of Committee: National Institute on would constitute a clearly unwarranted provisions set forth in sections Drug Abuse Special Emphasis Panel, invasion of personal privacy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

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as amended. The grant applications and Agenda: To review and evaluate grant This notice is being published less than 15 the discussions could disclose applications. days prior to the meeting due to the timing confidential trade secrets or commercial Place: Holiday Inn Chevy Chase, 5520 limitations imposed by the review and property such as patentable material, Wisconsin Avenue, Chevy Chase, MD 20815. funding cycle. Contact Person: Alfonso R. Ratoni, PhD., and personal information concerning Name of Committee: National Institute on Scientific Review Administrator, Scientific Alcohol Abuse and Alcoholism Special individuals associated with the grant Review Office, National Institute on Aging, Emphasis Panel, P60 Application Review. applications, the disclosure of which National Institutes of Health, 7201 Wisconsin Date: June 11, 2004. would constitute a clearly unwarranted Avenue, Room 2C212, Bethesda, MD 20892, Time: 2 p.m. to 3 p.m. invasion of personal privacy. 301/496–9666, [email protected]. Agenda: To review and evaluate grant Name of Committee: National Institute on This notice is being published less than 15 applications. Aging Initial Review Group, Neuroscience of days prior to the meeting due to the timing Place: National Institutes of Health, Aging Review Committee. limitations imposed by the review and NIAAA/Fishers Building, 5635 Fishers Lane, Date: June 2–3, 2004. funding cycle. Room 3041, MSC 9304, Bethesda, MD 20892 Time: 6 p.m. to 5 p.m. (Catalogue of Federal Domestic Assistance (Telephone Conference Call). Agenda: To review and evaluate grant Program Nos. 93.866, Aging Research, Contact Person: Mahadev Murthy, PhD, applications. National Institutes of Health, HHS) Scientific Review Administrator, Extramural Place: Hyatt Regency Bethesda, One Project Review Branch, Office of Scientific Dated: May 18, 2004. Bethesda Metro Center, 7400 Wisconsin Affairs, National Institute on Alcohol Abuse Avenue, Bethesda, MD 20814. LaVerne Y. Stringfield, and Alcoholism, 6000 Executive Blvd., Suite Contact Person: Louise L. Hsu, PhD, The Director, Office of Federal Advisory 409, Bethesda, MD 20892–7003, (301) 443– Bethesda Gateway Building, 7201 Wisconsin Committee Policy. 2860. Avenue/Suite 2C212, Bethesda, MD 20892, [FR Doc. 04–11835 Filed 5–25–04; 8:45 am] This notice is being published less than 15 days prior to the meeting due to the timing (301) 4696–9666, [email protected]. BILLING CODE 4140–01–M This notice is being published less than 15 limitations imposed by the review and days prior to the meeting due to the timing funding cycle. limitations imposed by the review and DEPARTMENT OF HEALTH AND Name of Committee: National Institute on funding cycle. Alcohol Abuse and Alcoholism Special HUMAN SERVICES Name of Committee: National Institute on Emphasis Panel, RFA–AA–04–002 SBIR Applications. Aging Initial Review Group, Biological Aging National Institutes of Health Review Committee. Date: July 15, 2004. Date: June 2, 2004. Time: 8 a.m. to 10 a.m. National Institute on Alcohol Abuse Agenda: To review and evaluate grant Time: 12 p.m. to 3 p.m. and Alcoholism; Notice of Closed Agenda: To review and evaluate grant applications. applications. Meeting Place: Holiday Inn Select Bethesda, 8120 Place: National Institute on Aging, Wisconsin Ave., Bethesda, MD 20814. Pursuant to section 10(d) of the Contact Person: Mahadev Murthy, PhD, Gateway Building, 7201 Wisconsin Ave., Federal Advisory Committee Act, as 2C212, Bethesda, MD 20814 (Telephone Scientific Review Administrator, Extramural Conference Call). amended (5 U.S.C. Appendix 2), notice Project Review Branch, Office of Scientific Contact Person: Alessandra M. Bini, PhD, is hereby given of the following Affairs, National Institute on Alcohol Abuse Health Scientist Administrator, Scientific meetings. and Alcoholism, 6000 Executive Blvd., Suite Review Office, National Institute on Aging, The meetings will be closed to the 409, Bethesda, MD 20892–7003, (301) 443– National Institutes of Health, 7201 Wisconsin public in accordance with the 2860. Avenue, Bethesda, MD 20892, 301–402– provisions set forth in sections This notice is being published less than 15 7708. 552b(c)(4) and 552(b)(c)(6), Title 5 days prior to the meeting due to the timing This notice is being published less than 15 U.S.C., as amended. The grant limitations imposed by the review and funding cycle. days prior to the meeting due to the timing applications and the discussions could limitations imposed by the review and disclose confidential trade secrets or (Catalogue of Federal Domestic Assistance funding cycle. Program Nos. 93.271, Alcohol Research commercial property such as patentable Career Development Awards for Scientists Name of Committee: National Institute on material, and personal information Aging Initial Review Group, Clinical Aging and Clinicians; 93.272, Alcohol National Review Committee. concerning individuals associated with Research Service Awards for Research Date: June 3–4, 2004. the contract proposals, the disclosure of Training; 93.273, Alcohol Research Programs; Time: 6:30 p.m. to 5 p.m. which would constitute a clearly 93.891, Alcohol Research Center Grants, Agenda: To review and evaluate grant unwarranted invasion of personal National Institutes of Health, HHS) applications. privacy. Dated: May 18, 2004. Place: Holiday Inn Chevy Chase, 5520 Name of Committee: National Institute on LaVerne Y. Stringfield, Wisconsin Avenue, Chevy Chase, MD 20815. Alcohol Abuse and Alcoholism Special Director, Office of Federal Advisory Contact Person: Alicja L. Markowska, PhD, Emphasis Panel, SAMe-R01 Application Committee Policy. DSC, Scientific Review Administrator, Review. [FR Doc. 04–11838 Filed 5–25–04; 8:45 am] Scientific Review Office, National Institute Date: June 11, 2004. on Aging, National Institute on Aging, Time: 2 p.m. to 3 p.m. BILLING CODE 4140–01–M National Institutes of Health, Room 2C212, Agenda: To review and evaluate grant 7201 Wisconsin Avenue, Bethesda, MD applications. 20814, 301–402–7703, Place: National Institutes of Health, DEPARTMENT OF HEALTH AND [email protected]. NIAAA/Fishers Building, 5635 Fishers Lane, HUMAN SERVICES This notice is being published less than 15 Room 3041, MSC 9304, Bethesda, MD 20892 days prior to the meeting due to the timing (Telephone Conference Call). National Institutes of Health limitations imposed by the review and Contact Person: Mahadev Murthy, PhD, funding cycle. Scientific Review Administrator, Extramural National Institute of Allergy and Name of Committee: National Institute on Project Review Branch, Office of Scientific Infectious Diseases; Notice of Closed Aging Special Emphasis Panel, Socio- Affairs, National Institute on Alcohol Abuse Meeting economic Status and Health. and Alcoholism, 6000 Executive Blvd., Suite Date: June 13–14, 2004. 409, Bethesda, MD 20892–7003, (301) 443– Pursuant to section 10(d) of the Time: 4 p.m. to 5:10 p.m. 2860. Federal Advisory Committee Act, as

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amended (5 U.S.C. Appendix 2), notice FY 2004 grant funds for Networking and (3) Evaluate, collect and analyze data is hereby given of the following Certifying Suicide Prevention Hotlines. regarding such issues as: As the use of meeting. A synopsis of this funding opportunity, the national suicide prevention number The meeting will be closed to the as well as many other Federal (including variations by State and area public in accordance with the Government funding opportunities, is code); reasons for callers’ use of the provisions set forth in section 552b(c)(4) also available at the Internet site: http:/ service; the nature and appropriateness and 552(c)(6), Title 5 U.S.C., as /www.grants.gov. of services provided; outcomes of the amended. The grant applications and For complete instructions, potential intervention (i.e., referrals made to the discussions could disclose applicants must obtain a copy of emergency, mental health and social confidential trade secrets or commercial SAMHSA’s standard Infrastructure services resources); and the technical property such as patentable material, Grants announcement (INF–04 PA efficiency and effectiveness of the and personal information concerning (MOD)), and the PHS 5161–1 (Rev. 7/00) telephone service that is provided to individuals associated with the grant application form before preparing and callers. The evaluation must address the applications, the disclosure of which submitting an application. The INF–04 effectiveness of intervention services would constitute a clearly unwarranted PA (MOD) describes the general provided by crisis centers within the invasion of personal privacy. program design and provides network as compared to crisis centers Name of Committee: National Institute of instructions for applying for all not in the network. Allergy and Infectious Diseases Special SAMHSA Infrastructure Grants, To achieve these goals, the applicant Emphasis Panel, Clinical Trials in Organ including the Networking and Certifying will be required to engage in the Transplantation. Suicide Prevention Hotlines grant. following activities: Date: June 14–15, 2004. Additional instructions and specific (1) Network Centers: The applicant Time: 8 a.m. to 5 p.m. requirements for this funding must demonstrate a capacity to network Agenda: To review and evaluate grant opportunity are described below. centers using telephone technology that applications. permits national access to crisis centers Place: Residence Inn Bethesda, 7335 I. Funding Opportunity Description: or hotline services through a single toll- Wisconsin Avenue, Bethesda, MD 20814. free number. This number will be Contact Person: Paul A. Armstad, PhD, Authority: Section 520A of the Public Scientific Review Administrator, Scientific selected by SAMHSA and maintained Health Service Act, as amended and subject by the applicant. SAMHSA will choose Review Program, Division of Extramural to the availability of funds. Activities, National Institutes of Health/ a number that is easy to remember and NIAID, 6700B Rockledge Drive, MSC 7616, Networking and Certifying Suicide is life affirming. The applicant will use Bethesda, MD 20892–7616, 301–402–7098, Prevention Hotlines grant program is this telephone number to establish and [email protected]. one of SAMHSA’s Infrastructure Grants. maintain the hotline network. At the (Catalogue of Federal Domestic Assistance In general, SAMHSA’s Infrastructure end of the grant period, SAMHSA will Program Nos. 93.855, Allergy, Immunology, Grants provide funds to increase the determine whether if it will continue to and Transplantation Research; 93.856, capacity of mental health and/or retain the number or release it to the Microbiology and Infectious Diseases substance abuse service systems to grantee. This determination will be Research, National Institutes of Health, HHS) support effective programs and services. made no later than six months prior to Dated: May 18, 2004. This particular grant will provide the end of the grant period. The LaVerne Y. Stringfield, funding to manage a toll-free national technology utilized must permit calls to Director, Office of Federal Advisory suicide prevention hotline network be directed immediately to a telephone Committee Policy. utilizing a life affirming number which suicide prevention worker who is [FR Doc. 04–11839 Filed 5–25–04; 8:45 am] routes calls from anywhere in the within geographic proximity to the BILLING CODE 4140–01–M United States to a network of local crisis caller. The network must have the centers that can link callers to local capacity to assist local crisis centers in emergency, mental health and social identifying the telephone numbers of DEPARTMENT OF HEALTH AND service resources. Grant funds must also callers at imminent risk of suicide in HUMAN SERVICES be used to increase the number of crisis need of emergency rescue who are centers certified in suicide prevention. unable or unwilling to provide a Substance Abuse and Mental Health The goals of the Networking and telephone number or location (e.g., Services Administration Certifying Suicide Prevention Hotlines caller ID, ANI, or call tracing). The grant program are to: applicant must describe in their Notice of Funding Availability (NOFA) (1) Increase the number of crisis proposed approach the type of call for a Grant for Networking and programs offering hotline services routing system to be used (i.e., carrier Certifying Suicide Prevention Hotlines which are networked through a single, driven advanced business networking or nationally accessible telephone number, a customized service hosted by a carrier Announcement Type: Initial. utilizing telecommunications but maintained through the applicant Funding Opportunity Number: SM technology that links callers to their organization or through subcontracts). 04–013. geographically nearest crisis center. It is The applicant should clearly explain Catalog of Federal Domestic expected that there will be at least one why they are proposing a particular Assistance (CFDA) Number: 93.243. crisis program offering hotline services approach. This discussion should Due Date for Applications: July 21, in all 50 states; include the following information: 2004. (2) Increase the number of crisis review literature that discusses (Note: Letters from State Single Point of centers/hotlines certified in suicide determination of peak usage periods in Contact (SPOC) in response to E.O. 12372 are prevention, e.g., having achieved order to determine the size of the due September 20, 2004.) defined standards in crisis worker network, average call drop rates and SUMMARY: The Substance Abuse and training, service delivery, lethality how the proposed approach seeks to Mental Health Services Administration assessments, organizational reduce call drops, the cost benefits to (SAMHSA), Center for Mental Health administration and program evaluation; the approach, and the specific features Services, announces the availability of and of the approach that will enhance the

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hotline network, and provide crucial callers using the toll-free crisis service. represent one of many possible effective data to the individual crisis centers and The applicant should either have, or interventions for suicidality. to SAMHSA. partner with, another organization that ‘‘Hotline’’ crisis services may be In addition to establishing the has a documented history of successful directly associated with a single crisis telephone network, the applicant must evaluation efforts. center, which also offers face-to-face clearly demonstrate the capability to (5) Sustainability: The applicant must client services, or be a ‘‘hotline-only’’ provide training and technical propose a sustainability plan that service in which there are no associated assistance to the individual crisis ensures that the program can be self- face-to-face services. Such ‘‘hotline- centers on utilizing the network supporting when Federal funding ends. only’’ centers may be hundreds or technology, provide assistance to obtain The applicant must demonstrate thousands of miles from the location of or upgrade equipment at the local crisis experience in sustaining similar the caller and often maintain databases centers in order to participate in the initiatives through blended public and of crisis, mental health, and social network, provide incentives to the local private funding. services local to the caller to which that crisis centers to maintain their (6) Financial Management: The person can be referred if indicated. certification, continue participation in selected applicant must demonstrate ‘‘Suicide prevention hotlines’’ are the network and provide call outcome existence of an adequate financial staffed with suicide prevention workers data to the applicant who will then management system (reference 45 CFR who establish and maintain contact aggregate data from all centers, analyze part 74, subpart C), and be capable of with the individual while identifying and report it to SAMHSA. administering Federal awards. and clarifying the problem, evaluating (2) Certification of Crisis Hotlines: Specifically, the applicant must the potential for suicide, assessing the The applicant must increase the number maintain and follow adequate policies individual’s strengths and resources, of crisis hotlines certified in suicide and procedures that safeguard assets and mobilizing available resources prevention. Crisis centers participating including paramedic or police and determine cost allowability, in the network should be certified in intervention and emergency psychiatric maintain an accounting system capable suicide prevention by the American care as needed. of segregating grant income and Association of Suicidology (AAS), or if ‘‘Suicide prevention hotlines’’ may be not certified by AAS, have met expenditures, maintain effective stand-alone ‘‘hotline only’’ services, accreditation standards accepted by accountability and control over grant may operate out of community agencies, AAS as equivalent, such as the Joint funds, maintain accounting records or be part of organized health and Commission on the Accreditation of supported by source documentation, mental health care delivery systems. Healthcare Organizations (JCAHO), the maintain an adequate procurement While suicide prevention hotlines have Commission on the Accreditation of system (including ability to administer been in existence for more than forty Rehabilitation Facilities (CARF), or subcontracts, if applicable), and years, access to such services in many Contact USA. The applicant should maintain property control. areas has been either highly variable or have experience with, or partner with, The activities described above fall non-existent. The multiplicity of phone an organization that has experience with within the following categories of numbers for local hotlines made certification of crisis centers in suicide allowable activities listed in the INF–04 national, state or regional public prevention. PA (MOD): provider/network education campaigns impossible. This (3) Resource Database Development: development, development of led to support for a single, toll free, The applicant must develop a Resource interagency coordination mechanisms, nationally accessible telephone number Database that can be accessed via the data infrastructure development, and for suicide prevention, utilizing Internet by all crisis centers, regardless evaluation. Activity in the other telecommunications technology that of their participation in the network. categories of allowable activity defined links callers to their geographically This resource database will quickly in the INF–04 PA (MOD) are allowed nearest crisis center. provide the hotline center with local only to the extent that the applicant can Though not all crisis centers have information on emergency, mental demonstrate that they are critical to the widely publicized ‘‘hotline’’ services, it health, and social service resources effective implementation of the is generally believed that most, if not within 50 miles of the caller’s activities that are required for this grant. all, centers field crisis calls from geographical area. The applicant should Background suicidal individuals. While face-to-face either have, or partner with, an assessment and counseling in the work organization that has a documented There are currently estimated to be of crisis centers are to a large degree history of developing such a over 500 operating ‘‘crisis centers’’ in done by health professionals, much of comprehensive resource database. The the United States, exclusive of military the important work of telephone crisis applicant may also propose to use other and employee assistance programs. intervention is done by trained currently existing databases. Some are specialty centers focusing on volunteers. The use of trained (4) Program Evaluation: The applicant crises related to domestic violence or volunteers in the role of telephone crisis must conduct an evaluation of the grant rape. Others see their mission as workers has existed for many years and project that accurately documents the responding to the needs of all types of spawned the development of standards population served by the toll-free crisis personal and family crises. The primary to guide them in their work. Workers line service, including variations in objective of the crisis center is to diffuse responding to suicidal callers should be usage by State and area code; the the immediate crisis, ensure the caller’s trained in the use of clinical reason(s) for callers’ use of the service; safety, and assist the caller to take the intervention techniques. The the nature and appropriateness of the next immediate steps toward resolving certification of crisis centers in suicide service that was provided; the the problem. In any type of serious prevention is a crucial component of outcome(s) (i.e., referrals made to personal crisis, the potential for suicidal this grant. Many crisis centers do not emergency, mental health, and social thoughts and behaviors exist. In operate out of organized health delivery service resources); and the technical published surveys, 10 percent of calls to systems, such as hospitals or efficiency and effectiveness of the all types of crisis programs involve community mental health centers. State telephone service that is provided to suicidality. Hotline crisis services laws and regulations governing the use

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of terms such as ‘‘crisis center’’, ‘‘crisis regulations, and satisfactorily perform III. Eligibility Information line’’, or ‘‘hotline’’ either do not exist or activities to achieve the goals described 1. Eligible Applicants vary widely. The majority of crisis below; center workers are volunteers who do • Seek SAMHSA approval for key Eligible applicants are domestic not fall under any state licensing laws positions to be filled. The key positions public and private nonprofit entities. for mental health professionals. Thus, include: project director, networking/ For example, State, local or tribal voluntary certification for meeting telephony director, certification governments; public or private nationally recognized suicide director, evaluation director, database universities and colleges; community- prevention standards is virtually the director; and faith-based organizations; and tribal organizations may apply. The statutory only form of external, task specific • Seek SAMHSA approval of quality control that exists for many authority for this program precludes proposed approach to networking of grants to for-profit organizations. crisis centers. The success of the hotlines prior to implementing network is ultimately tied to the proposed design and accept SAMHSA- 2. Cost Sharing or Matching adherence of participating crisis centers recommended modifications to to nationally recognized standards for Is not required. approach; suicide prevention. 3. Other • Consult with and accept guidance Definitions from CMHS staff on performance of Applicants must also meet certain Crisis center: A program that activities to achieve goals described application formatting and submission establishes immediate telephone below; requirements, or the application will be communication between people who are • Respond to requests for information screened out and will not be reviewed. emotionally distressed and individuals from CMHS; These requirements are described in Section IV–2 below, as well as in the who have been trained to provide • Agree to provide SAMHSA with INF–04 PA (MOD). telephone assistance to diffuse the data required for the Government crisis, ensure the caller’s safety, and Performance and Results Act (GPRA); IV. Application and Submission assist the caller to take next steps • Manage the toll free telephone Information toward resolving the problem. number selected by SAMHSA through Hotline crisis services: A telephone 1. Address To Request Application the end of the grant period and service directly associated with a single Package relinquish control of the telephone crisis center. number to SAMHSA or to another Complete application kits may be Suicide prevention hotline: A program obtained from the National Mental that provides telephone crisis organization, if required; • Health Information Center at 1–800– intervention services to individuals Produce required SAMHSA reports. 789–2647. When requesting an expressing suicidal thoughts or Role of SAMHSA staff: application kit for this program, the behavior, or to others calling on behalf • Maintain overall responsibility for applicant must specify the funding of such persons in crisis, with the monitoring the conduct and progress of opportunity title (Networking and objective of exploring alternatives to the suicide prevention hotline Certifying Suicide Prevention Hotlines) self-harm. networking and certification program; and the funding opportunity number II. Award Information • Approve proposed key positions/ (SM 04–013) for which detailed personnel information is desired. All information 1. Estimated Funding Available/Number • Review proposed approach and necessary to apply, including where to of Awards request modifications to approach and/ submit applications and application It is expected that up to $2.2 million or approve the approach; deadline instructions, is included in the will be available to fund one award in • Make recommendations regarding application kit. The PHS 5161–1 FY 2004. It is expected that only one continued funding; application form is also available Category 2—Comprehensive electronically via SAMHSA’s World • Provide guidance and technical Infrastructure Grant, as defined in the Wide Web home page: http:// assistance on project design; INF–04 PA (MOD), will be awarded. www.samhsa.gov (Click on ‘‘Grant • The maximum allowable award is $2.2 Approve all proposed subcontracts; Opportunities’’) and the INF–04 PA million in total costs (direct and • Review quarterly reports and (MOD) is available electronically at indirect) per year for three years. conduct a site visit, if warranted; http://www.samhsa.gov/grants/2004/ Proposed budgets cannot exceed the • Review and approve the evaluation standard/Infrastructure/index.asp. allowable amount in any year of the plan, including the sites selected to When submitting an application, be proposed project. The actual amount participate in the evaluation; sure to type ‘‘SM 04–013 Networking available for the award may vary, • Approve data collection plans and and Certifying Suicide Prevention depending on unanticipated program institute policies regarding data Hotlines’’ in Item Number 10 on the face requirements and the quality of the collection; page of the application form. Also, SAMHSA applicants are required to applications received. Annual • Recommend consultants for provide a DUNS Number on the face continuations will depend on the assisting with the resource database, page of the application. To obtain a availability of funds, progress in evaluation, and data collection, if DUNS Number, access the Dun and meeting program goals and objectives, needed; and and timely submission of required data Bradstreet Web site at http:// • Provide technical assistance, as and reports. www.dunandbradstreet.com or call 1– needed, on sustainability and to assist 866–705–5711. 2. Funding Instrument in disseminating the resource database 2. Content and Form of Application Cooperative agreement. to non-networked crisis centers. Role of the Grantee: • Provide a toll free number that is Submission • Comply with the terms of the award easy to remember, life affirming and test Appendices 3 and 5, referenced in the and all applicable grant rules and marketed. INF–04 PA (MOD) in Section IV–2, are

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not required and should not be included —Space will be measured on the funding announcement. Please do not in the application. Additional physical page. Space left blank within use staples, paper clips, and fasteners. information including required the Project Narrative (excluding Nothing should be attached, stapled, documents, required application margins) is considered part of the folded, or pasted. Do not use heavy or components, and application formatting Project Narrative, in determining lightweight paper, or any material that requirements is available in the INF–04 compliance. cannot be copied using automatic PA (MOD) in Section IV–2. • The page limit for Appendices copying machines. Odd-sized and Checklist for Formatting Requirements stated in the specific funding oversized attachments such as posters and Screenout Criteria for SAMHSA announcement cannot be exceeded. will not be copied or sent to reviewers. Grant Applications To facilitate review of your Do not include videotapes, audiotapes, application, follow these additional or CD-ROMs. SAMHSA’s goal is to review all guidelines. Failure to adhere to the applications submitted for grant following guidelines will not, in itself, 3. Submission Dates and Times funding. However, this goal must be result in your application being Applications must be received by July balanced against SAMHSA’s obligation screened out and returned without 21, 2004. You will be notified by postal to ensure equitable treatment of review. However, the information mail that your application has been applications. For this reason, SAMHSA provided in your application must be received. Additional submission has established certain formatting sufficient for review. Following these information is available in the INF–04 requirements for its applications. If you guidelines will help ensure your PA (MOD) in Section IV–3. do not adhere to these requirements, application is complete, and will help 4. Intergovernmental Review your application will be screened out reviewers to consider your application. and returned to you without review. • The 10 application components Applicants for this funding • Use the PHS 5161–1 application. • required for SAMHSA applications opportunity must comply with Applications must be received by should be included. These are: Executive Order 12372 (E.O. 12372). the application deadline. Applications —Face Page (Standard Form 424, which E.O. 12372, as implemented through received after this date must have a is in PHS 5161–1) Department of Health and Human proof of mailing date from the carrier —Abstract Services (DHHS) regulation at 45 CFR dated at least 1 week prior to the due —Table of Contents part 100, sets up a system for State and date. Private metered postmarks are not —Budget Form (Standard Form 424A, local review of applications for Federal acceptable as proof of timely mailing. which is in PHS 5161–1) financial assistance. Instructions for Applications not received by the —Project Narrative and Supporting complying with E.O. 12372 are provided application deadline or not postmarked Documentation in the INF–04 PA (MOD) in Section IV– at least 1 week prior to the application —Appendices 4. A current listing of State Single deadline will not be reviewed. —Assurances (Standard Form 424B, Points of Contact (SPOCs) is included in • Information provided must be which is in PHS 5161–1) sufficient for review. the application kit and is available at —Certifications (a form in PHS 5161–1) http://www.whitehouse.gov/omb/grants/ • Text must be legible. —Disclosure of Lobbying Activities spoc.html. —Type size in the Project Narrative (Standard Form LLL, which is in PHS cannot exceed an average of 15 5161–1) 5. Funding Restrictions characters per inch, as measured on —Checklist (a form in PHS 5161–1) Funds for the Networking and the physical page. (Type size in • Applications should comply with Certification of Suicide Prevention charts, tables, graphs, and footnotes the following requirements: Hotlines grant may not be used for will not be considered in determining —Provisions relating to confidentiality, implementation pilots, as stated in the compliance.) participant protection and the INF–04 PA (MOD). Additional —Text in the Project Narrative cannot protection of human subjects, as exceed 6 lines per vertical inch. information concerning funding indicated in the specific funding restrictions is available in the INF–04 • Paper must be white paper and 8.5 announcement. PA (MOD) in Section IV–5. inches by 11.0 inches in size. —Budgetary limitations as indicated in • To ensure equity among Sections I, II, and IV–5 of the specific V. Application Review Information applications, the amount of space funding announcement. 1. Evaluation Criteria allowed for the Project Narrative cannot —Documentation of nonprofit status as be exceeded. required in the PHS 5161–1. Applications will be reviewed against —Applications would meet this • Pages should be typed single- the Evaluation Criteria and requirement by using all margins (left, spaced with one column per page. requirements for the Project Narrative right, top, bottom) of at least one inch • Pages should not have printing on specified in the INF–04 PA (MOD). The each, and adhering to the page limit both sides. following information describes for the Project Narrative stated in the • Please use black ink, and number exceptions or limitations to the INF–04 specific funding announcement. pages consecutively from beginning to PA (MOD) and provides special —Should an application not conform to end so that information can be located requirements that pertain only to the these margin or page limits, SAMHSA easily during review of the application. grant for Networking and Certifying will use the following method to The cover page should be page 1, the Suicide Prevention Hotlines. determine compliance: The total area abstract page should be page 2, and the Note that implementation pilots of the Project Narrative (excluding table of contents page should be page 3. referenced in the INF–04 PA (MOD) margins, but including charts, tables, Appendices should be labeled and may not be included in this grant graphs and footnotes) cannot exceed separated from the Project Narrative and program. 58.5 square inches multiplied by the budget Section, and the pages should be Applicants must discuss the following page limit. This number represents numbered to continue the sequence requirements in their applications, in the full page less margins, multiplied • Send the original application and addition to the requirements specified by the total number of allowed pages. two copies to the mailing address in the in the INF–04 PA (MOD):

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1.1 In ‘‘Section A: Statement of Need’’ VII. Agency Contact for Additional Information Management Programs, a. The target population for this Information Office of Finance and Administration, program is the total potential number of For questions about program issues, TSA–17, 601 South 12th Street, suicidal persons who may seek help contact: Brenda Bruun, SAMHSA/ Arlington, Virginia 22202–4220; through hotline services in the United CMHS, Division of Prevention, telephone (571) 227–1954; facsimile States. The applicant should address the Traumatic Stress and Special Programs, (571) 227–2906. needs of this target population in 5600 Fishers Lane, Room 17C–26, SUPPLEMENTARY INFORMATION: Rockville, MD 20857; 301–443–4669; e- Section A of the Project Narrative. Transportation Security Administration mail: [email protected]. For b. Applicants may disregard the 4th (TSA) bullet in Section A that requests questions on grants management issues, applicants to show that the identified contact: Gwendolyn Simpson, Title: Registered Traveler (RT) Pilot need for the proposed project is SAMHSA/Division of Grants Program; Satisfaction and Effectiveness consistent with the State’s priorities. Management, 5600 Fishers Lane, Room Measurement Data Collection This requirement does not apply 13–103, Rockville, MD 20857; 301–443– Instruments. because the scope of this grant program 4456; e-mail: [email protected]. Type of Request: Emergency is nationwide. Dated: May 20, 2004. processing request of a new collection. OMB Control Number: Not yet 1.2 In ‘‘Section B: Proposed Daryl Kade, assigned. Approach’’ Director, Office of Policy, Planning and Budget, Substance Abuse and Mental Health Form(s): Electronic enrollment Applicants must address the goals Services Administration. application; satisfaction survey. and activities of the grant for [FR Doc. 04–11940 Filed 5–25–04; 8:45 am] Affected Public: Applicants to the RT Networking and Certifying Suicide BILLING CODE 4162–20–P Pilot Program and lead stakeholders. Prevention Hotlines identified in Abstract: TSA plans to conduct a pilot Section I of this NOFA when technology program in 2004, in a responding to the bullets in Section B of DEPARTMENT OF HOMELAND limited number of airports, to test and the INF–04 PA (MOD). SECURITY evaluate the merits of the Registered 1.3 In ‘‘Section D: Evaluation and Traveler (RT) concept. This pilot Data’’ Transportation Security Administration program (RT Pilot) is designed to positively identify qualified, known All SAMHSA grantees are required to Reports, Forms, and Recordkeeping travelers via advanced identification collect and report certain data, so that Requirements: Agency Information technologies for the purposes of SAMHSA can meet its obligations under Collection Activity Under OMB Review; expediting those passengers’ travel the Government Performance and Registered Traveler (RT) Pilot experience at the airport security Results Act (GPRA). The Networking Program; Satisfaction and checkpoints and thereby enabling TSA and Certifying Suicide Prevention Effectiveness Measurement Data to improve the allocation of its limited Hotlines grantee will be required to Collection Instruments security resources. report on the increase in the number of TSA will collect and retain a minimal hotline centers included in the network AGENCY: Transportation Security amount of personal information from and the increase in the number certified Administration (TSA), DHS. individuals who volunteer to participate in suicide prevention. Applicants must ACTION: Notice of emergency clearance in the RT Pilot that will be used to document their ability to collect and request. verify an applicant’s claimed identity, report on these measures in ‘‘Section E: SUMMARY: The U.S. Department of complete a security assessment, and, if Evaluation and Data’’ of their Homeland Security, Transportation applicable, issue an identification token applications Security Administration, has submitted prior to enrollment in the program. In 2. Review and Selection Process a request for emergency processing of a addition, TSA will administer two new information collection to the Office instruments to measure customer Information about the review and of Management and Budget (OMB) for satisfaction and to collect data on the selection process is available in the review and immediate clearance by June effectiveness of the pilot technologies INF–04 PA (MOD) in Section V–2. 1, 2004, under the Paperwork Reduction and business processes. The first VI. Award Administration Information Act of 1995 (Pub. L. 104–13, 44 U.S.C. instrument will be a survey of a Award administration information, 35). This notice announces that the representative percentage of the RT Pilot including award notices, administrative Information Collection Request (ICR) participants. The second instrument and national policy requirements, and abstracted below has been forwarded to will be an interview conducted with the reporting requirements are available in OMB for review and comment. The ICR key stakeholders at sites participating in the INF–04 PA (MOD) in Section VI. describes the nature of the information the RT Pilot. All surveys and interviews SAMHSA’s standard terms and collection and its expected burden. will be voluntary and anonymous. conditions are available at http:// DATES: Send your comments by June 25, Number of Respondents: 10,040. www.samhsa.gov/grants/2004/ 2004. A comment to OMB is most Estimated Annual Burden Hours: useful_info.asp. Note that the effective if OMB receives it within 30 3,738. Networking and Certifying Suicide days of publication. TSA is soliciting comments to— Prevention Hotlines grantee will be ADDRESSES: Comments may be faxed to (1) Evaluate whether the proposed required to provide quarterly progress/ the Office of Information and Regulatory information requirement is necessary for financial reports in addition to annual Affairs, Office of Management and the proper performance of the functions progress/financial reports. The quarterly Budget, Attention: DHS–TSA Desk of the agency, including whether the reporting format, including crisis center Officer, at (202) 395–5806. information will have practical utility; call data, is under development by FOR FURTHER INFORMATION CONTACT: (2) Evaluate the accuracy of the SAMHSA. Conrad Huygen, Privacy Act Officer, agency’s estimate of the burden;

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(3) Enhance the quality, utility, and Transportation Security Administration DEPARTMENT OF HOUSING AND clarity of the information to be (TSA) URBAN DEVELOPMENT collected; and (4) Minimize the burden of the Title: Airport Access Control Pilot [Docket No. FR–4907–M–20] Program (AACPP); Satisfaction and collection of information on those who Notice of Proposed Information Effectiveness Measurement Data are to respond, including through the Collection: Comment Request; Single use of appropriate automated, Collection Instruments. Family Property Disposition and electronic, mechanical, or other Type of Request: Emergency Acquisition (Conveyance) of technological collection techniques or processing request of a new collection. Mortgaged Properties other forms of information technology. OMB Control Number: Not yet Issued in Arlington, Virginia, on May 20, AGENCY: Office of the Assistant 2004. assigned. Secretary for Housing—Federal Housing Susan T. Tracey, Form(s): Enrollment and satisfaction Commissioner, HUD. Chief Administrative Officer. surveys. ACTION: Notice. [FR Doc. 04–11891 Filed 5–25–04; 8:45 am] Affected Public: Participants in SUMMARY: The proposed information BILLING CODE 4910–62–P AACPP and lead stakeholders. collection requirement described below Abstract: TSA intends to test and will be submitted to the Office of DEPARTMENT OF HOMELAND evaluate certain new and emerging Management and Budget (OMB) for SECURITY biometric and other technologies during review, as required by the Paperwork the Airport Access Control Pilot Reduction Act. The Department is Transportation Security Administration Program (AACPP). TSA will gather soliciting public comments on the biometric information, demographic subject proposal. Reports, Forms, and Record Keeping information, and airport user DATES: Comments Due Date: July 26, Requirements: Agency Information identification from a select group of 2004. Collection Activity Under OMB Review; participants at 20 locations to test the Airport Access Control Pilot Program ADDRESSES: Interested persons are use of emerging technologies for airport invited to submit comments regarding (AACPP); Satisfaction and access control and then evaluate those Effectiveness Measurement Data this proposal. Comments should refer to technologies using two satisfaction Collection Instruments the proposal by name and/or OMB instruments. The first instrument will Control Number and should be sent to: AGENCY: Transportation Security be a survey given to a representative Wayne Eddins, Reports Management Administration (TSA), DHS. sample of airport users and the second Officer, Department of Housing and ACTION: Notice of emergency clearance instrument will be an interview Urban Development, 451 7th Street, request. conducted with the lead stakeholder at SW., L’Enfant Plaza Building, Room each site and a small percentage of 8003, Washington, DC 20410 or SUMMARY: The U.S. Department of persons participating in the project. [email protected]. Homeland Security, Transportation Surveys and interviews will be Security Administration, has submitted FOR FURTHER INFORMATION CONTACT: Joe a request for emergency processing of a voluntary and anonymous. McCloskey, Director, Single Family new information collection to the Office Number of Respondents: 2,620. Asset Management, Department of of Management and Budget (OMB) for Estimated Annual Burden Hours: 780. Housing and Urban Development, 451 review and immediate clearance by June 7th Street SW., Washington, DC 20410, 1, 2004, under the Paperwork Reduction TSA is soliciting comments to— telephone (202) 708–1672 (this is not a Act of 1995 (Pub. L. 104–13, 44 U.S.C. (1) Evaluate whether the proposed toll free number) for copies of the 35). This notice announces that the information requirement is necessary for proposed forms and other available Information Collection Request (ICR) the proper performance of the functions information. abstracted below has been forwarded to of the agency, including whether the SUPPLEMENTARY INFORMATION: The OMB for review and comment. The ICR information will have practical utility; Department is submitting the proposed describes the nature of the information (2) Evaluate the accuracy of the information collection to OMB for collection and its expected burden. agency’s estimate of the burden; review, as required by the Paperwork DATES: Send your comments by June 25, (3) Enhance the quality, utility, and Reduction Act of 1995 (44 U.S.C. 2004. A comment to OMB is most chapter 35, as amended). effective if OMB receives it within 30 clarity of the information to be collected; and This Notice is soliciting comments days of publication. from members of the public and affected ADDRESSES: Comments may be faxed to (4) Minimize the burden of the agencies concerning the proposed the Office of Information and Regulatory collection of information on those who collection of information to: (1) Evaluate Affairs, Office of Management and are to respond, including through the whether the proposed collection is Budget, Attention: DHS–TSA Desk use of appropriate automated, necessary for the proper performance of Officer, at (202) 395–5806. electronic, mechanical, or other the functions of the agency, including FOR FURTHER INFORMATION CONTACT: technological collection techniques or whether the information will have Conrad Huygen, Privacy Act Officer, other forms of information technology. practical utility; (2) Evaluate the Information Management Programs, Issued in Arlington, Virginia, on May 20, accuracy of the agency’s estimate of the Office of Finance and Administration, 2004. burden of the proposed collection of TSA–17, 601 South 12th Street, information; (3) Enhance the quality, Arlington, Virginia 22202–4220; Susan T. Tracey, utility, and clarity of the information to telephone (571) 227–1954; facsimile Chief Administrative Officer. be collected; and (4) Minimize the (571) 227–2906. [FR Doc. 04–11892 Filed 5–25–04; 8:45 am] burden of the collection of information SUPPLEMENTARY INFORMATION: BILLING CODE 4910–62–P on those who are to respond; including

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the use of appropriate automated awarding an exclusive license to: Summary is also accessible at http:// collection techniques or other forms of Sequoia Scientific, Inc., of Bellevue, www.platteriver.org. information technology, e.g., permitting Washington 98005, on U.S. Patent No. FOR FURTHER INFORMATION, CONTACT: electronic submission of responses. 6,680,795 B2, entitled ‘‘Underwater Lynn Holt, Platte River EIS Office (303) This Notice also lists the following Microscope System.’’ 445–2096, or by sending an e-mail to information: Inquiries: If other parties are [email protected]. Title of Proposal: Single Family interested in similar activities, or have Property Disposition and Acquisition comments related to the prospective SUPPLEMENTARY INFORMATION: (Conveyance) of Mortgaged Properties. award, please contact Neil Mark, USGS, Reclamation and the Fish and Wildlife OMB Control Number, if applicable: 12201 Sunrise Valley Drive, MS 201, Service (Service) have prepared this 2502–0306. Reston, Virginia 20192, voice (703) 648– DEIS to analyze the impacts of the First Description of the need for the 4344, fax (703) 648–4706, or e-mail Increment (13 years) of a proposed information and proposed use: These [email protected]. Recovery Implementation Program information collections are needed to SUPPLEMENTARY INFORMATION: This (Program) to benefit the target species determine the condition of the property (whooping crane, interior least tern, upon conveyance, to determine the notice is submitted to meet the requirements of 35 U.S.C. 208 et seq. piping plover, and pallid sturgeon) and results of the repair contracts, and to their habitat in the Platte River Basin monitor the contractor’s performance in Dated: March 1, 2004. and to provide compliance with the maintaining the properties. The sales P. Patrick Leahy, Endangered Species Act (ESA) for contracts will be used as binding Associate Director for Geology. certain historic and future water uses in contracts between the purchaser and [FR Doc. 04–11830 Filed 5–25–04; 8:45 am] the Platte River Basin in Colorado, HUD. Respondents are potential BILLING CODE 4310–Y7–M Nebraska, and Wyoming. The habitat contractors, contractors who work for objectives of the proposed Program HUD, potential and actual purchasers of include: Improving flows in the Central HUD-owned properties. DEPARTMENT OF THE INTERIOR Platte River through water re-regulation Agency form numbers, if applicable: and conservation/supply projects; and HUD–9516A, 9519, 9519A, 9544, 9548, Bureau of Reclamation protecting, restoring, and maintaining at 9548A, 9548B, 9548C, and 9733. least 10,000 acres of habitat in the Estimation of the total numbers of [INT–DES–04–3] Central Platte River area between hours needed to prepare the information Platte River Recovery Implementation Lexington and Chapman, Nebraska. The collection including number of Program DEIS analyzes the impacts of four respondents, frequency of response, and alternatives to implement the Program. hours of response: The estimated AGENCY: Bureau of Reclamation, The programmatic DEIS focuses on number of burden hours needed to Interior. impacts that the Program may have on prepare the information collection is ACTION: Extension of review and 563,765 hours; the number of hydrology, water quality, land, target comment period for draft environmental species and their habitat, other species, respondents is 105,798 generating impact statement (DEIS). approximately 1,127,580 annual hydropower, recreation, economics, and social and cultural resources. responses; the frequency of response is SUMMARY: The notice of availability for on occasion; and the estimated time the DEIS was published in the Federal Subsequent National Environmental needed to prepare the response varies Register on January 26, 2004 (69 FR Policy Act and ESA documents required from 20 minutes to 30 minutes per 3600), with the public review and for implementation of specific Program response. comment period currently scheduled to actions will be tiered off of this Status of the proposed information end June 2, 2004. The public review and document. collection: Extension of currently comment period is being extended to Public Disclosure Statement approved collection. August 20, 2004, so that the public may have sufficient time to review the DEIS Comments received in response to Authority: The Paperwork Reduction Act this notice will become part of the of 1995, 44 U.S.C. chapter 35, as amended. along with the recently released administrative record for this project Dated: May 10, 2004. National Academy of Sciences (NAS) report entitled, ‘‘Endangered and and are subject to public inspection. Sean G. Cassidy, Threatened Species in the Platte River Comments, including names and home General Deputy Assistant Secretary for Basin.’’ addresses of respondents, will be Housing, Deputy Federal Housing available for public review. Individual Commissioner. DATES: Submit comments on the DEIS respondents may request that [FR Doc. 04–11847 Filed 5–25–04; 8:45 am] on or before August 20, 2004. Public Reclamation withhold their home BILLING CODE 4210–27–M hearings on the DEIS will be held address from public disclosure, which during late July and early August. Times will be honored to the extent allowable and locations will be announced in the by law. There also may be DEPARTMENT OF THE INTERIOR Federal Register and local media. circumstances in which Reclamation ADDRESSES: Written comments on, or would withhold a respondent’s identity Geological Survey requests for copies of, the DEIS should from public disclosure, as allowable by be addressed to the Platte River EIS law. If you wish to have your name and/ Patent, Trademark and Copyright Acts Office (PL–100), PO Box 25007, Denver, or address withheld, you must state this AGENCY: Geological Survey, Interior. Colorado, 80225–0007, telephone (303) prominently at the beginning of your ACTION: Notice of prospective intent to 445–2096, or by sending an e-mail to comment. Reclamation will make all award exclusive license. [email protected]. A copy of the DEIS submissions from organizations or Summary, and/or technical reports or businesses and from individuals SUMMARY: The United States Geological appendices may also be obtained by identifying themselves as Survey (USGS) is contemplating calling (303) 445–2096. The DEIS and representatives or officials of

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organizations or businesses available for can be obtained by contacting the By order of the Commission. public disclosure in their entirety. Commission’s TDD terminal on (202) Marilyn R. Abbott, Dated: May 19, 2004. 205–1810. General information Secretary to the Commission. Willie R. Taylor, concerning the Commission may also be [FR Doc. 04–11863 Filed 5–25–04; 8:45 am] Director, Environmental Policy & obtained by accessing its Internet server BILLING CODE 7020–02–P Compliance. (http://www.usitc.gov). The public [FR Doc. 04–11938 Filed 5–25–04; 8:45 am] record for this investigation may be INTERNATIONAL TRADE BILLING CODE 4310–MN–P viewed on the Commission’s electronic docket (EDIS) at http://edis.usitc.gov. COMMISSION SUPPLEMENTARY INFORMATION: The [Inv. No. 337–TA–496] INTERNATIONAL TRADE Commission issued a notice of COMMISSION In the Matter of Certain Home Vacuum investigation dated June 16, 2003, Packaging Products Notice of a [Inv. No. 337–TA–494] naming Auto Meter Products, Inc. Commission Determination Not To (‘‘Auto Meter’’) of Sycamore, Illinois, as Review an Initial Determination In the Matter of Certain Automotive the complainant and several companies Measuring Devices, Products Terminating the Investigation as to as respondents. On June 20, 2003, the Two Respondents on the Basis of a Containing Same, and Bezels for Such notice of investigation was published in Devices; Notice of Commission Settlement Agreement and Withdrawal the Federal Register. 68 FR 37023. The Decision Not To Review Three Initial of the Complaint as to a Third complaint alleged violations of section Determinations Terminating the Respondent; Termination of the Investigation as to Three Respondents 337 of the Tariff Act of 1930 in the Investigation importation and sale of certain on the Basis of Consent Orders; AGENCY: automotive measuring devices, products U.S. International Trade Issuance of Consent Orders Commission. containing same, and bezels for such AGENCY: U.S. International Trade devices, by reason of infringement of ACTION: Notice. Commission. U.S. Registered Trademark Nos. SUMMARY: Notice is hereby given that ACTION: Notice. 1,732,643 and 1,497,472, and U.S. the U.S. International Trade Supplemental Register No. 1,903,908, SUMMARY: Notice is hereby given that Commission has determined not to the U.S. International Trade and infringement of the complainant’s review the presiding administrative law Commission has determined not to trade dress. Subsequently, seven more judge’s (‘‘ALJ’s’’) initial determination review three initial determinations firms were added as respondents based (‘‘ID’’) granting a joint motion to (‘‘IDs’’) issued by the presiding on two separate motions filed by terminate the above-captioned administrative law judge (‘‘ALJ’’) complainant. investigation on the basis of a settlement terminating the above-captioned On April 21, 2004, the ALJ issued agreement and withdrawal of the investigation as to respondents GR three IDs (Orders Nos. 20, 21, and 22) complaint. Motorsports Inc., d/b/a Matrix GR terminating the investigation as to FOR FURTHER INFORMATION CONTACT: Motorsports, Inc. of Commerce, respondents GR Motorsports, Hiper, and Timothy P. Monaghan, Esq., Office of California (‘‘GR Motorsports’’), Hiper J & P (‘‘terminated respondents’’) the General Counsel, U.S. International Industries Inc. d/b/a R–1 Racing-Sports, (including two companies that J & P Trade Commission, 500 E Street, SW., Inc. of Garden Grove, California owns and does business as, PointZero Washington, DC 20436, telephone 202– (‘‘Hiper’’), and J & P Hamilton and QuickCar of Winder, Georgia, 205–3152. Copies of the public version Enterprises, Inc. of Winder, Georgia (‘‘J which were listed among the of the ID and all nonconfidential & P’’) (including two companies that J respondents in the notice of documents filed in connection with this & P owns and does business as, investigation are or will be available for PointZero Gauge Company investigation) on the basis of the settlement agreements and consent inspection during official business (‘‘PointZero’’) and QuickCar Racing hours (8:45 a.m. to 5:15 p.m.) in the orders. With regard to the terminated Products (‘‘QuickCar’’) of Winder, Office of the Secretary, U.S. respondents, the ALJ observed that each Georgia, which were listed among the International Trade Commission, 500 E of them filed a joint (together with respondents in the notice of Street, SW., Washington, DC 20436, investigation) on the basis of consent complainant Auto Meter) motion to telephone 202–205–2000. Hearing- orders. terminate based on settlement impaired persons are advised that agreements between each of the FOR FURTHER INFORMATION CONTACT: information on this matter can be Michael Liberman, Esq., Office of the terminated respondents and Auto Meter, obtained by contacting the General Counsel, U.S. International and proposed consent orders. The Commission’s TDD terminal on 202– Trade Commission, 500 E Street, SW., Commission investigative attorney filed 205–1810. General information Washington, DC 20436, telephone (202) responses in support of each of the joint concerning the Commission may also be 205–3115. Copies of the ALJ’s ID and all motions. No petitions for review of the obtained by accessing its Internet server other nonconfidential documents filed IDs were filed. (http://www.usitc.gov). The public in connection with this investigation are The authority for the Commission’s record for this investigation may be or will be available for inspection determination is contained in section viewed on the Commission’s electronic during official business hours (8:45 a.m. 337 of the Tariff Act of 1930, as docket (EDIS) at http://edis.usitc.gov. to 5:15 p.m.) in the Office of the amended (19 U.S.C. 1337), and in SUPPLEMENTARY INFORMATION: On August Secretary, U.S. International Trade section 210.42 of the Commission’s 18, 2003, the Commission instituted this Commission, 500 E Street, SW., Rules of Practice and Procedure (19 CFR investigation based upon a complaint Washington, DC 20436, telephone (202) 210.42). filed by Tilia, Inc. and Tilia 205–2000. Hearing-impaired persons are International (collectively, ‘‘Tilia’’). 68 advised that information on this matter Issued: May 19, 2004. FR 49521. In its complaint, Tilia alleges

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that the accused imported products April, 2, 2004, finding no violation of On April 15, 2004, Broadcom filed a infringe claims 3, 4, 6, 24–25, and 34 of section 337 of the Tariff Act of 1930, 19 petition for review of the final ID. On U.S. Patent No. 4,941,310. The notice of U.S.C. 1337, in the above-captioned April 22, 2004, the Commission investigation named Applica, Inc., and investigation. Accordingly, the investigative attorney and Microtune Applica Consumer Products, Inc. Commission has terminated the filed responses. (‘‘Applica’’); ZeroPack Co., Ltd., investigation with a finding of no Having reviewed the record in this (‘‘ZeroPack’’); and The Holmes Group, violation of section 337. investigation, including the parties’ Inc. and The Rival Company FOR FURTHER INFORMATION CONTACT: written submissions, the Commission (collectively ‘‘the Rival respondents’’) as Timothy P. Monaghan, Esq., Office of determined not to review (i.e., to adopt) respondents. the General Counsel, U.S. International the ID in its entirety. On March 29, 2004, the Commission Trade Commission, 500 E Street, SW., This action is taken under the issued notice that it had determined not Washington, DC 20436, telephone 202– authority of section 337 of the Tariff Act to review an ID granting the joint 205–3152. Copies of the public version of 1930, 19 U.S.C. 1337, and section motion of Tilia and the Rival of the ID and all nonconfidential 210.42 of the Commission’s Rules of respondents to terminate the documents filed in connection with this Practice and Procedure, 19 CFR 210.42. investigation as to the Rival respondents investigation are or will be available for Issued: May 20, 2004. on the basis of a settlement agreement. inspection during official business By order of the Commission. On April 22, 2004, the ALJ issued an hours (8:45 a.m. to 5:15 p.m.) in the Marilyn R. Abbott, ID (Order No. 59) granting the joint Office of the Secretary, U.S. Secretary to the Commission. motion of complainant Tilia and International Trade Commission, 500 E [FR Doc. 04–11865 Filed 5–25–04; 8:45 am] respondents Applica and ZeroPack to Street, SW., Washington, DC 20436, BILLING CODE 7020–02–P terminate the investigation based on a telephone 202–205–2000. Hearing- settlement agreement between Tilia and impaired persons are advised that Applica, and to terminate the information on this matter can be INTERNATIONAL TRADE investigation as to ZeroPack by obtained by contacting the COMMISSION withdrawal of the complaint, contingent Commission’s TDD terminal on 202– on the termination of the Applica. The 205–1810. General information Summary of Commission Practice Commission investigative attorney concerning the Commission may also be Relating to Administrative Protective supported the joint motion. obtained by accessing its Internet server Orders No party filed a petition to review the (http://www.usitc.gov.) The public AGENCY: U.S. International Trade subject ID. record for this investigation may be Commission. The authority for the Commission’s viewed on the Commission’s electronic ACTION: action is contained in section 337 of the docket (EDIS) at http://edis.usitc.gov. Summary of Commission practice relating to administrative Tariff Act of 1930, as amended (19 SUPPLEMENTARY INFORMATION: The protective orders. U.S.C. 1337) and in section 210.42 of Commission instituted this the Commission’s Rules of Practice and investigation, which concerns SUMMARY: Since February 1991, the U.S. Procedure (19 CFR 210.42). allegations of unfair acts in violation of International Trade Commission Issued: May 20, 2004. section 337 in the importation and sale (‘‘Commission’’) has issued an annual By order of the Commission. of certain power amplifier chips, report on the status of its practice with Marilyn R. Abbott, broadband tuner chips, transceiver respect to violations of its Secretary to the Commission. chips, and products containing same, on administrative protective orders [FR Doc. 04–11864 Filed 5–25–04; 8:45 am] April 4, 2003, based on a complaint (‘‘APOs’’) in investigations under Title filed by Broadcom Corporation of Irvine, VII of the Tariff Act of 1930 in response BILLING CODE 7020–02–P California (‘‘Broadcom’’). 68 FR 16551. to a direction contained in the The only respondent named in the Conference Report to the Customs and INTERNATIONAL TRADE investigation is Microtune, Inc. of Plano, Trade Act of 1990. Over time, the COMMISSION Texas (‘‘Microtune’’). The complaint Commission has added to its report alleged that the imported products of discussions of APO breaches in [Inv. No. 337–TA–490] Microtune infringe claim 1 of U.S. Commission proceedings other than those under Title VII and violations of In the Matter of Certain Power Patent No. 6,445,039, (‘‘the ‘039 patent’’) the Commission’s rule on bracketing Amplifier Chips, Broadband Tuner and claim 2 of U.S. Patent No. 5,682,379 business proprietary information Chips, Transceiver Chips, and (‘‘the ‘379 patent’’). The investigation (‘‘BPI’’) (the ‘‘24-hour rule’’), 19 CFR Products Containing Same; Notice of was subsequently terminated as to the 207.3(c). This notice provides a Commission Determination Not To ‘‘379 patent. On April 2, 2004, the ALJ issued his summary of investigations of breaches Review a Final Initial Determination final ID finding no violation of section in proceedings under Title VII, sections Finding No Violation of Section 337; 337 based on his findings that claim 1 202 and 204 of the Trade Act of 1974, Termination of the Investigation of the ‘039 patent is anticipated by two as amended, section 421 of the Trade AGENCY: U.S. International Trade patents and two prior art Agreements Act of 1974, as amended, Commission. semiconductors, and invalid due to and section 337 of the Tariff Act of ACTION: Notice. obviousness. The ALJ also found that 1930, as amended, completed during the accused non-die paddle products of calendar year 2003. There was one SUMMARY: Notice is hereby given that respondent Microtune infringe claim 1 completed investigation of a 24-hour the U.S. International Trade of the ‘039 patent, but that Microtune’s rule violation during that period. The Commission has determined not to die paddle products do not infringe that Commission intends that this report review the final initial determination claim. He also found that the ‘039 patent educate representatives of parties to (‘‘ID’’) issued by the presiding is not unenforceable due to inequitable Commission proceedings as to some administrative law judge (‘‘ALJ’’) on conduct. specific types of APO breaches

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encountered by the Commission and the 500 E Street, SW., Washington, DC (6) Transmit each document corresponding types of actions the 20436, tel. (202) 205–2000. containing BPI disclosed under this Commission has taken. APO: I. In General FOR FURTHER INFORMATION CONTACT: (i) with a cover sheet identifying the Carol McCue Verratti, Esq., Office of the The current APO form for document as containing BPI, General Counsel, U.S. International antidumping and countervailing duty (ii) with all BPI enclosed in brackets Trade Commission, telephone (202) investigations, which the Commission and each page warning that the 205–3088. Hearing impaired individuals has used since March 2001, requires the document contains BPI, are advised that information on this applicant to swear that he or she will: (iii) if the document is to be filed by matter can be obtained by contacting the (1) Not divulge any of the BPI a deadline, with each page marked Commission’s TDD terminal at (202) obtained under the APO and not ‘‘Bracketing of BPI not final for one 205–1810. General information otherwise available to him, to any business day after date of filing,’’ and concerning the Commission can also be person other than— (iv) if by mail, within two envelopes, obtained by accessing its Internet server (i) personnel of the Commission the inner one sealed and marked (http://www.usitc.gov). concerned with the investigation, ‘‘Business Proprietary Information—To SUPPLEMENTARY INFORMATION: (ii) the person or agency from whom be opened only by [name of recipient]’’, Representatives of parties to the BPI was obtained, and the outer one sealed and not marked as containing BPI; investigations conducted under Title VII (iii) a person whose application for (7) Comply with the provision of this of the Tariff Act of 1930, sections 202 disclosure of BPI under this APO has APO and section 207.7 of the and 204 of the Trade Act of 1974, as been granted by the Secretary, and Commission’s rules; amended, section 421 of the Trade (iv) other persons, such as paralegals Agreements Act of 1974, as amended, (8) Make true and accurate and clerical staff, who (a) are employed representations in the authorized and section 337 of the Tariff Act of or supervised by and under the 1930, as amended, may enter into APOs applicant’s application and promptly direction and control of the authorized notify the Secretary of any changes that that permit them, under strict applicant or another authorized conditions, to obtain access to BPI (Title occur after the submission of the applicant in the same firm whose application and that affect the VII) or confidential business application has been granted; (b) have a information (‘‘CBI’’) (sections 201–204, representations made in the application need thereof in connection with the (e.g., change in personnel assigned to section 421 and section 337) of other investigation; (c) are not involved in parties. See 19 U.S.C. 1677f; 19 CFR the investigation); competitive decisionmaking for an (9) Report promptly and confirm in 207.7; 19 U.S.C. 2252(i); 19 CFR 206.17; interested party which is a party to the 19 U.S.C. 1337(n); 19 CFR 210.5, 210.34. writing to the Secretary any possible investigation; and (d) have submitted to breach of the APO; and The discussion below describes APO the Secretary a signed Acknowledgment (10) Acknowledge that breach of the breach investigations that the for Clerical Personnel in the form APO may subject the authorized Commission has completed, including a attached hereto (the authorized applicant and other persons to such description of actions taken in response applicant shall also sign such sanctions or other actions as the to breaches. The discussion covers acknowledgment and will be deemed Commission deems appropriate breach investigations completed during responsible for such persons’ including the administrative sanctions calendar year 2003. compliance with the APO); Since 1991, the Commission has and actions set out in this APO. published annually a summary of its (2) Use such BPI solely for the The APO further provides that breach actions in response to violations of purposes of the Commission of an APO may subject an applicant to: Commission APOs and the 24-hour rule. investigation or for judicial or binational (1) Disbarment from practice in any See 56 FR 4846 (Feb. 6, 1991); 57 FR panel review of such Commission capacity before the Commission along 12,335 (Apr. 9, 1992); 58 FR 21,991 investigation; with such person’s partners, associates, (Apr. 26, 1993); 59 FR 16,834 (Apr. 8, (3) Not consult with any person not employer, and employees, for up to 1994); 60 FR 24,880 (May 10, 1995); 61 described in paragraph (1) concerning seven years following publication of a FR 21,203 (May 9, 1996); 62 FR 13,164 BPI disclosed under this APO without determination that the order has been (March 19, 1997); 63 FR 25064 (May 6, first having received the written consent breached; 1998); 64 FR 23355 (April 30, 1999); 65 of the Secretary and the party or the (2) Referral to the United States FR 30434 (May 11, 2000); 66 FR 27685 representative of the party from whom Attorney; (May 18, 2001); 67 FR 39425 (June 7, such BPI was obtained; (3) In the case of an attorney, 2002); 68 FR 28256 (May 23, 2003). This (4) Whenever materials (e.g., accountant, or other professional, report does not provide an exhaustive documents, computer disks, etc.) referral to the ethics panel of the list of conduct that will be deemed to be containing such BPI are not being used, appropriate professional association; a breach of the Commission’s APOs. store such material in a locked file (4) Such other administrative APO breach inquiries are considered on cabinet, vault, safe, or other suitable sanctions as the Commission determines a case-by-case basis. container (N.B.: storage of BPI on so- to be appropriate, including public As part of the effort to educate called hard disk computer media is to release of or striking from the record any practitioners about the Commission’s be avoided, because mere erasure of information or briefs submitted by, or current APO practice, the Commission data from such media may not on behalf of, such person or the party Secretary issued in March 2001 a third irrecoverably destroy the BPI and may he represents; denial of further access to edition of An Introduction to result in violation of paragraph C of the BPI in the current or any future Administrative Protective Order Practice APO); investigations before the Commission; in Import Injury Investigations (Pub. L. (5) Serve all materials containing BPI and issuance of a public or private letter 3403). This document is available upon disclosed under this APO as directed by of reprimand; and request from the Office of the Secretary, the Secretary and pursuant to section (5) Such other actions, including but U.S. International Trade Commission, 207.7(f) of the Commission’s rules; not limited to, a warning letter, as the

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Commission determines to be occurred, sanctions are not warranted, public document. This is so even appropriate. and therefore has found it unnecessary though the attorney exercising direction Commission employees are not to issue a second letter concerning what or control over the economist or signatories to the Commission’s APOs sanctions might be appropriate. Instead, consultant may also be held responsible and do not obtain access to BPI through it issues a warning letter to the for the breach of the APO. APO procedures. Consequently, they are individual. A warning letter is not The records of Commission not subject to the requirements of the considered to be a sanction. investigations of alleged APO breaches APO with respect to the handling of Sanctions for APO violations serve in antidumping and countervailing duty BPI. However, Commission employees two basic interests: (a) preserving the cases are not publicly available and are are subject to strict statutory and confidence of submitters of BPI that the exempt from disclosure under the regulatory constraints concerning BPI, Commission is a reliable protector of Freedom of Information Act, 5 U.S.C. and face potentially severe penalties for BPI; and (b) disciplining breachers and 552, section 135(b) of the Customs and noncompliance. See 18 U.S.C. 1905; deterring future violations. As the Trade Act of 1990, and 19 U.S.C. Title 5, U.S. Code; and Commission Conference Report to the Omnibus 1677f(g). personnel policies implementing the Trade and Competitiveness Act of 1988 The breach most frequently statutes. observed, ‘‘[T]he effective enforcement investigated by the Commission An important provision of the of limited disclosure under involves the APO’s prohibition on the Commission’s rules relating to BPI is the administrative protective order depends dissemination of BPI to unauthorized ‘‘24–hour’’ rule. This rule provides that in part on the extent to which private persons. Such dissemination usually parties have one business day after the parties have confidence that there are occurs as the result of failure to delete deadline for filing documents effective sanctions against violation.’’ BPI from public versions of documents containing BPI to file a public version H.R. Conf. Rep. No. 576, 100th Cong., filed with the Commission or of the document. The rule also permits 1st Sess. 623 (1988). transmission of proprietary versions of changes to the bracketing of information The Commission has worked to documents to unauthorized recipients. in the proprietary version within this develop consistent jurisprudence, not Other breaches have included: the one-day period. No changes —other only in determining whether a breach failure to bracket properly BPI in than changes in bracketing—may be has occurred, but also in selecting an proprietary documents filed with the made to the proprietary version. The appropriate response. In determining Commission; the failure to report rule was intended to reduce the the appropriate response, the immediately known violations of an incidence of APO breaches caused by Commission generally considers APO; and the failure to supervise inadequate bracketing and improper mitigating factors such as the adequately non-legal personnel in the placement of BPI. The Commission unintentional nature of the breach, the handling of BPI. urges parties to make use of the rule. If lack of prior breaches committed by the Counsel participating in Title VII a party wishes to make changes to a breaching party, the corrective measures investigations have reported to the document other than bracketing, such as taken by the breaching party, and the Commission potential breaches typographical changes or other promptness with which the breaching involving the electronic transmission of corrections, the party must ask for an party reported the violation to the public versions of documents. In these extension of time to file an amended Commission. The Commission also cases, the document transmitted appears document pursuant to section considers aggravating circumstances, to be a public document with BPI 201.14(b)(2) of the Commission’s rules. especially whether persons not under omitted from brackets. However, the BPI the APO actually read the BPI. The II. Investigations of Alleged APO is actually retrievable by manipulating Commission considers whether there Breaches codes in software. The Commission has are prior breaches by the same person or found that the electronic transmission of Upon finding evidence of an APO persons in other investigations and a public document containing BPI in a breach or receiving information that multiple breaches by the same person or recoverable form was a breach of the there is a reason to believe one has persons in the same investigation. APO. occurred, the Commission Secretary The Commission’s rules permit The Commission advised in the notifies relevant offices in the agency economists or consultants to obtain preamble to the notice of proposed that an APO breach investigation file access to BPI under the APO if the rulemaking in 1990 that it will permit has been opened. Upon receiving economist or consultant is under the authorized applicants a certain amount notification from the Secretary, the direction and control of an attorney of discretion in choosing the most Office of General Counsel (OGC) begins under the APO, or if the economist or appropriate method of safeguarding the to investigate the matter. The OGC consultant appears regularly before the confidentiality of the BPI. However, the prepares a letter of inquiry to be sent to Commission and represents an Commission cautioned authorized the possible breacher over the interested party who is a party to the applicants that they would be held Secretary’s signature to ascertain the investigation. 19 CFR 207.7(a)(3) (B) and responsible for safeguarding the possible breacher’s views on whether a (C). Economists and consultants who confidentiality of all BPI to which they breach has occurred. If, after reviewing obtain access to BPI under the APO are granted access and warned the response and other relevant under the direction and control of an applicants about the potential hazards information, the Commission attorney nonetheless remain of storage on hard disk. The caution in determines that a breach has occurred, individually responsible for complying that preamble is restated here: the Commission often issues a second with the APO. In appropriate letter asking the breacher to address the circumstances, for example, an [T]he Commission suggests that certain questions of mitigating circumstances economist under the direction and safeguards would seem to be particularly and possible sanctions or other actions. control of an attorney may be held useful. When storing business proprietary information on computer disks, for example, The Commission then determines what responsible for a breach of the APO by storage on floppy disks rather than hard disks action to take in response to the breach. failing to redact APO information from is recommended, because deletion of In some cases, the Commission a document that is subsequently filed information from a hard disk does not determines that although a breach has with the Commission and served as a necessarily erase the information, which can

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often be retrieved using a utilities program. Case 1: The Commission determined breach within a relatively short period Further, use of business proprietary that two attorneys breached the APO of time. In addition, the attorney had information on a computer with the when one of the attorneys failed to been publicly sanctioned within the capability to communicate with users outside delete BPI from the public version of a past two years, but not suspended. The the authorized applicant’s office incurs the risk of unauthorized access to the prehearing brief. The attorney who was Commission found that although none information through such communication. If responsible for preparing the public of the attorney’s prior breaches was a computer malfunctions, all business version of the brief and who failed to egregious enough to warrant a public proprietary information should be erased delete the BPI was the lead attorney and reprimand when considered separately, from the machine before it is removed from the firm’s APO Compliance Officer. the public reprimand was warranted for the authorized applicant’s office for repair. However, this was his first title VII the series of breaches that demonstrated While no safeguard program will insulate an investigation before the Commission. a disturbing and unacceptable pattern of authorized applicant from sanctions in the The second attorney, a name partner overall failure to safeguard information event of a breach of the administrative protective order, such a program may be a and more senior attorney in the firm, released under APO. mitigating factor. participated substantially in the Case 2: The Commission issued a investigation and participated in the private letter of reprimand to an Preamble to notice of proposed drafting of the confidential version of attorney for failing to redact CBI from rulemaking, 55 FR 24100, 24103 (June the brief. The Commission found that the public version of a prehearing brief. 14, 1990). the senior attorney had also breached The brief was a joint brief with another The Commission has recently the APO because, despite the more law firm, but the Commission found disposed of an APOB investigation junior attorney’s inexperience and the that the attorney from the other law firm concerning a section 337 investigation. lengthy series of APO breaches that had and a consultant and a second attorney In that case, to be summarized with been caused by various members of his from the breaching attorney’s law firm other cases completed in 2004, attorneys firm, he did not participate in the were not responsible for the final review failed to notify the Commission about preparation of the public brief and/or of the brief. A private letter of their receipt of a subpoena from another supervise the junior attorney more reprimand was issued even though this government agency that would require closely to prevent a new breach. was the attorney’s first breach of a the disclosure of BPI obtained under the Because he was the lead attorney and Commission APO, the breach was APO. Counsel in section 337 the firm’s APO Compliance Officer, the inadvertent, the attorney’s firm changed investigations are reminded that Commission determined that the junior its APO procedures to avoid future Commission rule 210.34(d)(1) requires attorney would receive a private letter of breaches of this type, and the attorney that the Commission be notified in reprimand, even though it was his first took immediate corrective measures to writing immediately by anyone breach, no non-signatories had read the cure the breach once he was informed receiving such a subpoena or court or BPI, he took immediate corrective that there was a possible breach. The administrative order, discovery request, measures to cure the breach, and his Commission decided to issue a private agreement, or other written request firm changed its APO procedures to letter of reprimand because the seeking disclosure to persons who are avoid future breaches of this type. Commission received no assurance from not permitted access to the information Although the attorney claimed that his the attorney that non-signatories had not under either a Commission protective inexperience with bracketing BPI may read the CBI. The Commission sent the order or Commission rule 210.5(b). have played a part in the errors, the attorney two letters of inquiry and a Commission rule 210.34(d)(2) provides Commission determined that he should letter seeking his comments on possible that the Commission may impose be held to a higher standard of care sanctions and mitigating circumstances. sanctions upon any person who because the purpose of his position as All of the letters asked for his comments willfully fails to comply with section APO Compliance Officer was to prevent on whether a non-signatory had read the 210.34(d)(1). Failure to comply with breaches like the one he failed to CBI. The attorney did not address the that rule may also be considered an prevent in this matter. The Commission question in the first or third letters; in aggravating circumstance in also considered the fact that the attorney the second letter he merely stated that determining an appropriate sanction for took the APO Compliance position with he could not confirm with the recipients a breach connected with compliance the knowledge that several members of of the CBI that only APO signatories had with the subpoena or order. his firm had been investigated over a viewed the CBI. The attorney never III. Specific Investigations in Which relatively short period of time for prior explained why he could not confirm the APO breaches, and that aggressive facts. The Commission noted that more Breaches Were Found review of his firm’s submissions was than one firm which was a recipient of The Commission presents the therefore necessary. the brief were non-signatories of the following case studies to educate users The Commission determined to APO. Thus, without sufficient followup about the types of APO breaches found sanction the senior attorney by or explanation from the attorney and by the Commission. The studies provide publishing in the Federal Register a because CBI was made available to the factual background, the actions public letter of reprimand and to several non-signatories, the Commission taken by the Commission, and the suspend him for a period of six months presumed that the CBI was viewed by a factors considered by the Commission from access to APO information in any non-signatory of the APO. in determining the appropriate actions. Commission investigation. In addition, Case 3: An economic consultant The Commission has not included some the Commission ordered that at least prepared and distributed an exhibit at a of the specific facts in the descriptions two attorneys review all documents to Commission hearing. The exhibit of investigations where disclosure of be filed with the Commission by his law contained CBI that was taken from such facts could reveal the identity of a firm for APO compliance for a period of tables that were bracketed as particular breacher. Thus, in some five years from the date of publication confidential APO information in the cases, apparent inconsistencies in the of the sanction in the Federal Register. Prehearing Staff Report. During the facts set forth in this notice result from The Commission decided to issue the hearing, the consultant was informed of the Commission’s inability to disclose public letter of reprimand and suspend the possible breach and he took particular facts more fully. the attorney because this was his fourth immediate steps to retrieve the exhibit.

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All but one or two copies were CBI by an economic consultant under Commission to issue a private letter of retrieved. The consultant had argued the attorney’s direction and control, reprimand to both attorneys. The breach that the information was not CBI especially in light of the fact that the was not inadvertent; the attorneys because later in the investigation it was consultant in question previously had interpreted the APO, without seeking determined that the data itself was breached an APO in a prior case that Commission guidance, to allow them to erroneous and corrected data was also had involved the lead attorney and retain APO documents beyond the date included in the Posthearing Staff his firm. The Commission determined to set by the APO for return or destruction Report. The Commission determined issue the lead attorney in the first firm of APO documents; and the attorneys that the information was CBI since it a warning letter, in spite of the committed a second breach in their use was taken from a Commission document aggravating circumstances that existed of the APO documents for a purpose that was clearly marked as containing in this case, because of the unusual other than the Commission’s CBI. The Commission sanctioned the circumstances of the APO in this investigation. consultant with a private letter of multiproduct investigation which Case 5: The Commission found that reprimand because the breach was permitted the consultant to receive CBI an attorney and a legal assistant intentional; the Commission presumed from another attorney and work breached the APO by serving a that a non-signatory reviewed the CBI separately from the attorneys in the first document containing BPI upon since one or two of the exhibits were not law firm. individuals not authorized to view BPI. retrieved and non-signatories attended Case 4: The Commission determined The Commission issued private letters the hearing; and the consultant had that two attorneys breached the APO by of reprimand to both individuals. previously been found to have breached failing to return or destroy all copies of The document had been prepared for an APO and was issued a warning letter the CBI disclosed under the APO within filing and service by the legal assistant within a reasonably short period before 60 days of completion of the and signed by the attorney. The legal the occurrence of this breach. The Commission’s investigation and by assistant mistakenly used the public Commission took into consideration the using the retained documents for a service list instead of the APO service consultant’s immediate attempts to purpose other than the Commission’s list to serve the document. retrieve the exhibit and the fact that his investigation. Consequently, two law firms ineligible The attorneys represented a party in consulting firm modified its procedures to receive BPI were served with the a section 201 investigation. They argued to avoid similar breaches in the future. document. A lawyer in one of those that the failure to return or destroy the The Commission also investigated firms opened the envelope and read the whether attorneys in two law firms had documents on a timely basis was document long enough to determine breached the APO in this matter. One of inadvertent as they were not sure when that it contained BPI that he was the law firms had included the the Commission investigation had ineligible to receive. At that point, the consultant on its APO application and ended. They also argued that the lawyer stopped reading and notified the the lead attorney for that firm had documents, although retained by them, attorney who signed the document agreed to exercise direction and control were not used for any other purpose about the possible breach. Once over the consultant’s handling of the than the Commission investigation. notified, the attorney was able to APO materials. Another law firm also The Commission found conflicting retrieve the document from both had hired the consultant to assist in the statements in the submissions from the ineligible law firms, including from the same investigation, but on a different attorneys. Relying primarily on the product than that of the first law firm. initial statements regarding the second ineligible law firm which had That second firm gave the consultant breaches, the Commission found that not opened the sealed envelope. the information on this second product the breach was not inadvertent, and that The mitigating circumstances in this and it was for this product that the the attorneys had retained the case included the fact that the breach exhibit had been prepared and documents so they could review them was inadvertent, neither the attorney concerning which the Commission in preparing their client’s product nor the legal assistant had any prior hearing was held. The consultant was exclusion submission to USTR. In breaches within the recent past, they not included on the APO application of reaching its decision, the Commission made prompt efforts to limit the the second law firm, but was entitled to did not equate mere retention with use, possibility of disclosure to persons not have the information on any product in but found that something more had on the APO, and they took steps to this multiproduct investigation as long occurred. prevent breaches in the future. The as he was included on one APO The Commission denied the aggravating circumstances that application. The Commission found that attorneys’ request for reconsideration of supported the issuance of private letters none of the attorneys in the second firm the finding that the documents were of reprimand were the facts that a breached the APO because none was used for something other than the person not subject to the APO viewed responsible for preparation of the Commission’s investigation because the the BPI and that the breach was exhibit and they had not signed an APO arguments were made during the breach discovered by someone other than the application agreeing to exercise phase of the Commission’s investigation attorney or legal assistant. direction and control over the or they could have been made. Case 6: The Commission determined consultant’s handling of APO materials. There were several mitigating that one attorney breached the APO by The Commission issued a no violation circumstances in this matter, including failing to ensure, as lead counsel in a breach to the lead attorney in the second the facts that it was the first APO breach Commission investigation, that all of the firm, but admonished him to be more for both attorneys, there was no law firm personnel who would be attentive in preventing breaches in the evidence that unauthorized persons working with BPI contained in future. gained access to the CBI, and the documents received under APO were The Commission determined that the attorneys’ law firm has instituted a signatories to the APO. One other lead attorney in the first law firm written policy of checking the Federal attorney in the firm had access to and breached the APO by failing to provide Register on a daily basis for used BPI under the APO adequate supervision over the handling Commission notices. There were also notwithstanding that he was not a of CBI and by permitting the release of aggravating circumstances that led the signatory to the APO. The Commission

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found that this attorney had violated 19 lead attorney on the investigation breach was inadvertent, it was the CFR 201.15. breached the APO. The Commission attorneys’ and analysts’ first breach, An attorney in the law firm determined that the attorney did not they reported the breach promptly to the discovered that one of the attorneys breach the APO. Although he was, in Commission, and they took corrective working on the investigation in the law general, responsible for the economist’s measures to prevent similar breaches in firm was not on the APO service list actions, he could not reasonably have the future. after the investigation had been foreseen that the economist would have The Commission did not issue a completed. He notified the Commission inserted an APO document into the warning letter to the legal secretary, but immediately about the possible breach. exhibits. The attorney had approved the cautioned him to ensure in future In determining that the lead attorney exhibits and did not anticipate any investigations that he has signed the should receive a private letter of additions to them. The Commission Acknowledgement before accessing CBI. reprimand, the Commission considered determined that the lead attorney had Case 9: The Commission found that the mitigating circumstances that the not breached the APO because he had an attorney breached the APO by firm discovered the breach and notified reasonably delegated his supervisory electronically transmitting a prehearing the Commission immediately, the lead responsiblities over the economist to the brief that contained both masked and attorney voluntarily conducted classes attorney and that attorney was not redacted BPI and BPI that had been for his firm concerning the handling of experienced and had no prior breaches neither masked nor redacted to two non- BPI, the breach was inadverent, and the that would have put the lead attorney signatories of the APO. The Commission non-signatory attorney handled the APO on notice that more supervision was issued a private letter of reprimand materials as if he were a signatory. necessary. because at least one of the non- However, the Commission also The law firm and the economist had signatories read the BPI that had neither considered the aggravating circumstance argued that a breach did not occur been masked nor redacted and there was that the lead attorney had received a because there was no BPI in the a delay in the attorney’s notification of warning letter in a previous breach exhibits. They argued that the the Commission about the possible investigation within the recent past. information that was considered BPI breach. In reaching this decision, the In determining to issue a warning was publicly available. The Commission Commission considered the mitigating letter to the non-signatory attorney, the found that, although a small part of the circumstances that the attorney had no Commission stated that it considers BPI had been made public during the prior breaches, he notified the ‘‘good cause’’ for imposition of a preliminary phase of the investigation, Commission of the breach, and he warning letter pursuant to 19 CFR the remainder was BPI and included immediately took appropriate corrective 201.15 to be the equivalent of a breach questionnaire responses or clarification measures. of an APO. However, it decided not to to questionnaire responses. During the breach phase of the issue any sanction for the attorney’s The Commission determined to issue investigation, the attorney argued that conduct because this was the only a warning letter to the economist the electronic ‘‘whiting-out’’ of the BPI breach-equivalent action in which he because the breach was unintentional, was sufficient to protect it. In response, had been involved within the two-year this was his first breach, and the copy the Commission noted that it has period generally examined by the vendor merely copied the documents consistently found that it is a breach of Commission for purposes of and did not review the BPI. In addition, the APO to send an electronic document determining sanctions, his action was once the economist realized that a to persons not on the APO in which the not willful, he treated BPI as if he had breach might have occurred, he BPI had been electronically masked or signed the APO, and he reported and immediately notified the attorney, who ‘‘whited-out’’ since the BPI can be remedied the objectionable conduct took prompt and effective action to stop retrieved by altering the software print shortly after he had learned of it. any further dissemination of the BPI. codes. The Commission also dismissed Case 7: The Commission issued a The Commission noted in its letters to the attorney’s arguments that the BPI warning letter to an economist after the economist and attorney that the that had neither been masked nor finding he breached the APO by Commission was not notified of the redacted was not BPI. The Commission transmitting exhibits containing BPI to a possible breach for 30 days after it was found that most of the data in question non-signatory copy vendor. The discovered. The Commission stated that had been questionnaire responses that economist had substantial experience it will expect more prompt notification were bracketed as BPI in the prehearing handling APO material in Commission by them with regard to any possible report. Questionnaire responses are title VII investigations. He was working APO breaches in the future, in treated by the Commission as BPI in on the investigation under the direction compliance with the APO which their entirety, unless the information is and control of an attorney in a law firm. requires signatories to ‘‘[r]eport otherwise available from a public Prior to the economist taking the promptly * * * any possible breach.’’ source, or is a non-numerical exhibits to the copy vendor, the attorney Case 8: The Commission issued characterization of aggregate trends. The supervising him had reviewed the warning letters to three attorneys and Commission considered certain public documents to be sure there was no BPI two international trade analysts in one sources that the attorney claimed in them. After the attorney’s review, the firm for permitting a legal secretary to revealed the information, but found that economist decided to add another have access to CBI even though he had the exact information was not publicly document to the exhibits that included not signed the APO Acknowledgment available. BPI. Although from earlier discussions for Clerical Personnel and, therefore, his Case 10: The Commission determined with the attorney the economist had name was not included on the that an attorney breached the APO in a reason to question whether the vendor Secretary’s confidential certificate of section 337 investigation by was a signatory to the APO, he handed service. The attorneys and international transmitting a confidential version of a the documents directly to the copy trade analysts were all signatories to the brief filed in the appeal of the vendor without determining whether APO and had worked on the Commission investigation to persons the vendor was a signatory to the APO. Commission’s investigation. The who were not signatories to the APO. The Commission considered whether Commission decided to issue a warning The Commission stated in the warning the economist, the attorney, and the letter instead of sanctions because the letter to the attorney that this finding

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was consistent with prior Issued: May 20, 2004. mechanical, or other technological determinations when the Commission Marilyn R. Abbott, collection techniques or other forms determined that making CBI available to Secretary to the Commission. of information technology e.g., unauthorized persons constitutes a [FR Doc. 04–11862 Filed 5–25–04; 8:45 am] permitting electronic submission of breach of the APO, regardless of BILLING CODE 7020–02–P responses. whether the unauthorized persons Overview of this information actually viewed the CBI. collection: (1) Type of Information Collection: The Commission determined to issue DEPARTMENT OF JUSTICE Extension of a currently approved the warning letter to the attorney Bureau of Alcohol, Tobacco, Firearms collection. instead of a sanction because the breach and Explosives (2) Title of the Form/Collection: was unintentional, he had no prior Application for an Amended Federal warnings or sanctions regarding APO Agency Information Collection Firearms License. breaches within the recent past, he took Activities: Proposed Collection; (3) Agency form number, if any, and prompt action to remedy the breach, Comments Requested the applicable component of the and no non-signatory to the APO Department of Justice sponsoring the actually read the electronically ACTION: 60-Day notice of information collection: Form Number: ATF F transmitted brief. collection under review: Application for 5300.38. Bureau of Alcohol, Tobacco, an Amended Federal Firearms License. Rule Violation: The Commission Firearms and Explosives. (4) Affected public who will be asked issued a warning letter to an attorney for The Department of Justice (DOJ), or required to respond, as well as a brief violating the Commission’s 24-hour Bureau of Alcohol, Tobacco, Firearms abstract: Primary: Business or other for- rule, 19 CFR 207.3. On the day and Explosives (ATF), has submitted the profit. Other: Individual or households. following information collection request following the filing of a confidential The form is used when a Federal to the Office of Management and Budget prehearing brief in a Commission firearms licensee makes application to (OMB) for review and approval in investigation, the attorney filed a public change the location of the firearms accordance with the Paperwork version of the brief and a revised business premises. The applicant must Reduction Act of 1995. The proposed confidential version. Both versions certify that the proposed new business information collection is published to contained additions to and deletions of premises will be in compliance with obtain comments from the public and text on several pages and there were State and local law for that location. several pages missing from an exhibit. affected agencies. Comments are (5) An estimate of the total number of The Commission found that this encouraged and will be accepted for respondents and the amount of time violated the 24-hour rule because that ‘‘sixty days’’ until July 26, 2004. This estimated for an average respondent to rule specficially precludes changes process is conducted in accordance with respond: It is estimated that 18,000 5 CFR 1320.10. other than bracketing changes and the respondents will complete a 1 hour and If you have comments especially on 15 minute form. deletion of confidential information the estimated public burden or during the 24-hour period after the (6) An estimate of the total public associated response time, suggestions, burden (in hours) associated with the original filing. The Commission noted or need a copy of the proposed that the rule allowed attorneys to seek collection: There are an estimated information collection instrument with 22,500 annual total burden hours leave to make other changes but, in this instructions or additional information, case, the attorney did not. associated with this collection. please contact David Adinolfi, ATF If additional information is required The Commission issued a warning National Licensing Center, Room 400, contact: Brenda E. Dyer, Deputy letter instead of a sanction because the 2600 Century Parkway, NE., Atlanta, Clearance Officer, United States changes appeared to be inadvertent and Georgia 30345. Department of Justice, Justice the attorney had no record of a rule Written comments and suggestions Management Division, Policy and violation or APO breach within the from the public and affected agencies Planning Staff, Patrick Henry Building, recent past. concerning the proposed collection of Suite 1600, 601 D Street, NW., information are encouraged. Your Washington, DC 20530. IV. Investigations in Which No Breach comments should address one or more Was Found of the following four points: Dated: May 19, 2004. —Evaluate whether the proposed Brenda E. Dyer, There were two APOB investigations collection of information is necessary Department Deputy Clearance Officer, PRA, in which the Commission determined for the proper performance of the Department of Justice. that the APO had not been breached. functions of the agency, including [FR Doc. 04–11767 Filed 5–25–04; 8:45 am] One involved testimony at a hearing whether the information will have BILLING CODE 4410–FY–M that might have disclosed BPI. Through practical utility; its investigation the Commission —Evaluate the accuracy of the agencies determined that the information estimate of the burden of the DEPARTMENT OF JUSTICE disclosed was not BPI because it was proposed collection of information, Drug Enforcement Administration publicly available. In the other including the validity of the investigation, the Commission’s staff methodology and assumptions used; Importation of Controlled Substances; determined that no BPI was served on —Enhance the quality, utility, and Notice of Application a party that was not on the APO service clarity of the information to be list because the data belonged to the collected; and Pursuant to section 1008 of the attorney’s own client and was not other —Minimize the burden of the collection Controlled Substances Import and company data received under the APO. of information on those who are to Export Act (21 U.S.C. 958(1)), the respond, including through the use of Attorney General shall, prior to issuing By order of the Commission. appropriate automated, electronic, a registration under this Section to a

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bulk manufacturer of a controlled Dated: May 5, 2004. DEPARTMENT OF JUSTICE substance in Schedule I or II and prior William J. Walker, to issuing a registration under Section Deputy Assistant Administrator, Office of Drug Enforcement Administration 1002(a) authorizing the importation of Diversion Control, Drug Enforcement Manufacturer of Controlled such a substance, provide Administration. Substances; Notice of Application manufacturers holding registrations for [FR Doc. 04–11818 Filed 5–25–04; 8:45 am] the bulk manufacture of the substance BILLING CODE 4410–09–M Pursuant to § 1301.33(a) of Title 21 of an opportunity for a hearing. the Code of Federal Regulations (CFR), Therefore, in accordance with this is notice that on February 24, 2004, § 1301.34 of Title 21, Code of Federal DEPARTMENT OF JUSTICE Varian, Inc. Lake Forest, 25200 Regulations (CFR), notice is hereby Commercentre Drive, Lake Forest, Drug Enforcement Administration given that on March 17, 2004, California 92630–8810, made application by renewal to the Drug Boehringer Ingelheim Chemicals, Inc., Manufacturer of Controlled Enforcement Administration (DEA) for 2820 N. Normandy Drive, Petersburg, Substances; Notice of Application registration as a bulk manufacturer of Virginia 23805, made application by the basic classes of controlled renewal to the Drug Enforcement Pursuant to § 1301.33(a) of Title 21 of substances listed below. Administration to be registered as an the Code of Federal Regulations (CFR), importer of Phenylacetone (8501), a this is notice that on March 17, 2004, Drug Schedule basic class of controlled substance listed Boehringer Ingelheim Chemicals Inc., in Schedule II. 2820 N. Normandy Drive, Petersburg, Phencyclidine (7471) ...... II 1- The firm plans to import Virginia 23805, made application by Piperidinocyclohexanecarbonitr- Phenylacetone for the bulk manufacture renewal to the Drug Enforcement ile (8603) ...... II of amphetamine. Administration (DEA) for registration as Benzoylecgonine (9180) ...... II Any manufacturer holding, or a bulk manufacturer of the basic classes applying for, registration as a bulk of controlled substances listed below. The firm plans to manufacture small manufacturer of the basic classes of quantities of controlled substances for controlled substances may file written Drug Schedule use in diagnostic products. Any other such applicant and any person who is comments on or objections to the Amphetamine (1100) ...... II application described above and may, at presently registered with DEA to Methylphenidate (1724) ...... II manufacture such substance may file the same time, file a written request for Methadone (9250) ...... II comments or objections to the issuance a hearing on such application in Methadone Intermediate (9254) ... II of the proposed registration. accordance with 21 CFR 1301.43 in Dextropropoxyphene, bulk (non- Any such comments or objections such form as prescribed by 21 CFR dosage forms) (9273) ...... II may be addressed, in quintuplicate, to 1316.47. Levo-alphacetylmethadol (9648) .. II the Deputy Assistant Administrator, Any such comments, objections, or Fentanyl (9801) ...... II Office of Diversion Control, Drug requests for a hearing may be addressed, Enforcement Administration, United in quintuplicate, to the Deputy Assistant The firm plans to manufacture the States Department of Justice, Administrator, Office of Diversion listed controlled substances for Washington, DC 20537, Attention: Control, Drug Enforcement formulation into finished Federal Register Representative, Office Administrator, Office of Diversion pharmaceuticals. of Chief Counsel (CCD) and must be Control, Drug Enforcement Any other such applicant and any filed no later than June 25, 2004. Administration, United States person who is presently registered with Dated: May 5, 2004. Department of Justice, Washington, DC DEA to manufacture such substance William J. Walker, 20537, Attention: Federal Register may file comments or objections to the Deputy Assistant Administrator, Office of Representative, Office of Chief Counsel issuance of the proposed registration. Diversion Control, Drug Enforcement (CCD) and must be filed no later than Any such comments or objections Administration. June 25, 2004. may be addressed, in quintuplicate, to [FR Doc. 04–11819 Filed 5–25–04; 8:45 am] This procedure is to be conducted the Deputy Assistant Administrator, BILLING CODE 4410–09–M simultaneously with and independent Office of Diversion Control, Drug of the procedures described in 21 CFR Enforcement Administration, United 1301.34(b),(c),(d),(e), and (f). As noted States Department of Justice, DEPARTMENT OF LABOR in a previous 1975 notice at 40 FR Washington, DC 20537, Attention: Employee Benefits Security 43745–46 (September 23, 1975), all Federal Register Representative, Office Administration applicants for registration to import of Chief Counsel (CCD) and must be basic class of any controlled substance filed no later than July 26, 2004. 125th Plenary Meeting; Advisory in Schedule I or II are and will continue Dated: May 5, 2004. Council on Employee Welfare and to be required to demonstrate to the Pension Benefits Plans; Notice of William J. Walker, Deputy Assistant Administrator, Office Meeting of Diversion Control, Drug Enforcement Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Pursuant to the authority contained in Administration that the requirements Administration. section 512 of the Employee Retirement for such registration pursuant to 21 [FR Doc. 04–11820 Filed 5–25–04; 8:45 am] Income Security Act of 1974 (ERISA), 29 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 BILLING CODE 4410–09–M U.S.C. 1142, the 125th open meeting of CFR 1311.42(a),(b),(c),(d),(e), and (f) are the full Advisory Council on Employee satisfied. Welfare and Pension Benefit Plans will be held on Tuesday, June 15, 2004.

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The meeting will take place in Room p.m. to 6:30 p.m. on July 1st, and from other activities, general policy issues S. 2508, U.S. Department of Labor 9:30 a.m. to 5 p.m. on July 2nd, will be and other business as necessary. Building, 200 Constitution Avenue, NW, closed. Any person may observe meetings, or Washington, DC 20210. The purpose of The closed portions of these meetings portions thereof, of advisory panels that the meeting, which will begin at 1:30 are for the purpose of Panel review, are open to the public, and, if time p.m. and end at approximately 4 p.m., discussion, evaluation, and allows, may be permitted to participate is to swear in the new members, recommendation on applications for in the panel’s discussions at the introduce the Council Chair and Vice financial assistance under the National discretion of the panel chairman and Chair, receive an update from the Foundation on the Arts and the with the approval of the full-time Assistant Secretary of Labor for the Humanities Act of 1965, as amended, Federal employee in attendance. Employee Benefits Security including information given in If you need special accommodations Administration, and determine the confidence to the agency by grant due to a disability, please contact the topics to be addressed by the Council in applicants. In accordance with the Office of AccessAbility, National 2004. determination of the Chairman of April Endowment for the Arts, 1100 Organizations or members of the 14, 2004, these sessions will be closed Pennsylvania Avenue, NW., public wishing to submit a written to the public pursuant to subsection Washington, DC 20506, 202/682–5532, statement may do so by submitting 20 (c)(6) of section 552b of Title 5, United TDY–TDD 202/682–5496, at least seven copies on or before June 4, 2004 to States Code. (7) days prior to the meeting. Debra Golding at the ERISA Advisory Any person may observe meetings, or Further information with reference to Council, U.S. Department of Labor, portions thereof, of advisory panels that this meeting can be obtained from Ms. Room N–5656, 200 Constitution are open to the public, and if time Kathy Plowitz-Worden, Office of Avenue, NW, Washington, DC 20210. allows, may be permitted to participate Guidelines & Panel Operations, National Statements received on or before June 4, in the panel’s discussions at the Endowment for the Arts, Washington, 2004 will be included in the record of discretion of the panel chairman. DC, 20506, or call 202/682–5691. the meeting. Individuals or If you need special accommodations Dated: May 20, 2004. representatives of organizations wishing due to a disability, please contact the Kathy Plowitz-Worden, to address the Advisory Council should Office of AccessAbility, National Panel Coordinator, Panel Operations, forward their request to Debra Golding Endowment for the Arts, 1100 National Endowment for the Arts. at the above address or via telephone at Pennsylvania Avenue, NW., [FR Doc. 04–11933 Filed 5–25–04; 8:45 am] (202) 693–8664. Oral presentations will be limited to 10 minutes, but an Washington, DC 20506, 202/682–5532, BILLING CODE 7537–01–P extended statement may be submitted TDY-TDD 202/682–5496, at least seven for the record. Individuals with (7) days prior to the meeting. Further information with reference to NATIONAL FOUNDATION ON THE disabilities who need special ARTS AND THE HUMANITIES accommodations should contact Debra this meeting can be obtained from Ms. Kathy Plowitz-Worden, Office of Golding by June 4 at the address National Endowment for the Arts; indicated in this notice. Guidelines & Panel Operations, National Endowment for the Arts, Washington, Leadership Initiatives Advisory Panel Signed at Washington, DC, this 19th day of DC 20506, or call 202/682–5691. May, 2004. Pursuant to section 10(a)(2) of the Ann L. Combs, Dated: May 20, 2004. Federal Advisory Committee Act (Pub. L. 92–463), as amended, notice is hereby Assistant Secretary, Employee Benefits Kathy Plowitz-Worden, Security Administration. Panel Coordinator, Panel Operations, given that two teleconference meetings of the Leadership Initiatives Advisory [FR Doc. 04–11821 Filed 5–25–04; 8:45 am] National Endowment for the Arts. [FR Doc. 04–11932 Filed 5–25–04; 8:45 am] Panel, AccessAbility section, to the BILLING CODE 4510–29–M National Council on the Arts will be BILLING CODE 7537–01–P held from Room 724 at the Nancy Hanks Center, 1100 Pennsylvania Avenue, NATIONAL FOUNDATION ON THE NW., Washington, DC, 20506 as follows: ARTS AND THE HUMANITIES NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES June 7, 2004, (National Accessibility National Endowment for the Arts; Award, Study of Careers in the Arts). This Combined Arts Advisory Panel National Endowment for the Arts; meeting, from 1:30 p.m. to 3 p.m., will be Fellowships Advisory Panel closed. Pursuant to section 10(a)(2) of the June 16, 2004, (Universal Design). This Federal Advisory Committee Act (Pub. Pursuant to section 10(a)(2) of the meeting, from 1:30 p.m. to 3 p.m., will be L. 92–463), as amended, notice is hereby Federal Advisory Committee Act (Pub. closed. given that a meeting of the Combined L. 92–463), as amended, notice is hereby The closed portions of meetings are for the given that a meeting of the Fellowships purpose of Panel review, discussion, Arts Advisory Panel, Theater/Musical evaluation, and recommendation on Theater section (Access to Artistic Advisory Panel, Music section (NEA applications for financial assistance under Excellence category) to the National Jazz Masters category) to the National the National Foundation on the Arts and the Council on the Arts will be held on June Council on the Arts will be held on June Humanities Act of 1965, as amended, 28-July 2, 2004 in Room 730 at the 15, 2004 from 9 p.m. to 5:30 p.m. in including information given in confidence to Nancy Hanks Center, 1100 Pennsylvania Room M–07 at the Nancy Hanks Center, the agency by grant applicants. In accordance Avenue, NW., Washington, DC 20506. 1100 Pennsylvania Avenue, NW., with the determination of the Chairman of A portion of this meeting, from 3 p.m. Washington, DC, 20506. April 14, 2004, these sessions will be closed to 4:30 p.m. on July 1st, will be open to This meeting will be open to the to the public pursuant to subsection (c)(6) of 5 U.S.C. 552b. the public for policy discussion. The public on a space available basis. Further information with reference to this remaining portions of this meeting, from Discussion will include the Jazz Masters meeting can be obtained from Ms. Kathy 9:30 a.m. to 6:30 p.m. on June 28th– National Touring Initiative, the issue of Plowitz-Worden, Office of Guidelines & 30th, from 9:30 a.m. to 3 p.m. and 4:30 Jazz Education, Touring, Broadcast, Panel Operations, National Endowment for

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the Arts, Washington, DC 20506, or call 202/ (Board). The notice also describes the group discussions between Board 682–5691. functions of the Board. Notice of this members and representatives of national Dated: May 20, 2004. meeting is required by section 10(a)(2) organizations with an interest and Kathy Plowitz-Worden, of the Federal Advisory Committee Act. investment in literacy, including Panel Coordinator, Panel Operations, This document is intended to notify the education and workforce development National Endowment for the Arts. general public of their opportunity to organizations, foundations, and [FR Doc. 04–11934 Filed 5–25–04; 8:45 am] attend the meeting. Individuals who business, and learner organizations. will need accommodations for a During the small group discussions, the BILLING CODE 7537–01–P disability in order to attend the meeting Board will also discuss the Institute’s (e.g., interpreting services, assistive future work and conduct other Board NATIONAL FOUNDATION ON THE listening devices, or materials in business as necessary. On June 16, 2004, ARTS AND THE HUMANITIES alternative format) should notify Liz the meeting will be closed from 5 p.m. Hollis at telephone number (202) 233– to 6:30 p.m. to review the applications National Endowment for the Arts; 2072 no later than June 9, 2004. We will of candidates for the position of Leadership Initiatives Advisory Panel attempt to meet requests for permanent director for the Institute. On accommodations after this date but June 17, 2004 from 8:30 a.m. to 5:30 Pursuant to section 10(a)(2) of the cannot guarantee their availability. The p.m. and June 18, 2004, from 8:30 a.m. Federal Advisory Committee Act (Pub. meeting site is accessible to individuals to 2:30 p.m., the Board meeting will be L. 92–463), as amended, notice is hereby with disabilities. closed to the public to interview given that a meeting of the Leadership DATE AND TIME: Open sessions—June 16, candidates for the position of Executive Initiatives Advisory Panel, Music 2004, from 8 a.m. to 5 p.m. Closed Director. The review of candidates’ section, to the National Council on the sessions—June 16, 2004, from 5 p.m. to applications, candidate interviews and Arts will be held from 12 p.m. to 1:30 6:30 p.m., June 17, 2004, from 8:30 a.m. subsequent discussions will touch upon p.m. on June 10, 2004 at the Omni to 5:30 p.m. and June 18, 2004 from 8:30 matters that would likely disclose William Penn Hotel, Parlor D, 530 a.m. to 2:30 p.m. information of a personal nature where William Penn Place, Pittsburgh, ADDRESSES: Washington, DC. The exact disclosure would constitute a clearly Pennsylvania. This meeting will be location will be posted on NIFL’s Web unwarranted invasion of personnel closed. site when confirmed. http:// privacy. The discussion may therefore The closed portions of meetings are www.nifl.gov. be held in closed session under for the purpose of Panel review, exemptions 2 and 6 of the Government discussion, evaluation, and FOR FURTHER INFORMATION CONTACT: Liz in the Sunshine Act, 5 U.S.C. 552b(c)(2) recommendation on applications for Hollis, Special Assistant to the Director; and (6). A summary of the activities at financial assistance under the National National Institute for Literacy, 1775 I the closed session and related matters Foundation on the Arts and the Street, NW., Suite 730, Washington, DC that are informative to the public and Humanities Act of 1965, as amended, 20006; telephone number: (202) 233– consistent with the policy of 5 U.S.C. including information given in 2072; email: [email protected]. 552b will be available to the public confidence to the agency by grant SUPPLEMENTARY INFORMATION: The Board within 14 days of the meeting. applicants. In accordance with the is established under section 242 of the Records are kept of all Advisory determination of the Chairman of April Workforce Investment Act of 1998, P.L. Board proceedings and are available for 14, 2004, these sessions will be closed 105–220 (20 U.S.C. 9252). The Board public inspection at the National to the public pursuant to subsection (c) consists of ten individuals appointed by Institute for Literacy, 1775 I Street, NW., (6) of 5 U.S.C. 552b. the President with the advice and Suite 730, Washington, DC 20006, from Further information with reference to consent of the Senate. The Board 8:30 a.m. to 5 p.m. advises and makes recommendations to this meeting can be obtained from Ms. Dated: May 21, 2004. Kathy Plowitz-Worden, Office of the Interagency Group, composed of the Sandra L. Baxter, Guidelines & Panel Operations, National Secretaries of Education, Labor, and Endowment for the Arts, Washington, Health and Human Services, which Interim Director. DC, 20506, or call 202/682–5691. administers the National Institute for [FR Doc. 04–11931 Filed 5–25–04; 8:45 am] BILLING CODE 6055–01–P Dated: May 20, 2004. Literacy (Institute). The Interagency Group considers the Board ’s Kathy Plowitz-Worden, recommendations in planning the goals Panel Coordinator, Panel Operations, of the Institute and in implementing any NATIONAL SCIENCE FOUNDATION National Endowment for the Arts. programs to achieve those goals. [FR Doc. 04–11935 Filed 5–25–04; 8:45 am] Specifically, the Board performs the Business and Operations Advisory BILLING CODE 7537–01–P following functions: (a) Makes Committee: Notice of Meeting recommendations concerning the In accordance with Federal Advisory appointment of the Director and the Committee Act (Pub. L. 92–463, as NATIONAL INSTITUTE FOR LITERACY staff of the Institute; (b) provides amended), the National Science independent advice on operation of the Foundation announces the following National Institute for Literacy Advisory Institute; and (c) receives reports from Board meeting: the Interagency Group and the Name: Business and Operations AGENCY: National Institute for Literacy. Institute’s Director. Advisory Committee (9556). ACTION: Notice of a partially closed The National Institute for Literacy Date/Time: June 15, 2044; 1 p.m. to 5 meeting. Advisory Board will meet June 16–18, p.m. (E.S.T.). 2004. On June 16, an open meeting will Place: Teleconference. Please contact SUMMARY: This notice sets forth the be held from 8:30 a.m. to 5 p.m. The Joan Miller (below) for a dial-in number schedule and a summary of the agenda meeting will focus on the Institute’s role National Science Foundation, 4201 for an upcoming meeting of the National in meeting the nation’s literacy needs. Wilson Boulevard, Room 525–II, Institute for Literacy Advisory Board The meeting will be composed of small Arlington, VA.

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Type of Meeting: Open. NUCLEAR REGULATORY A. Timing and Location of Evidentiary Contact Person: Joan Miller, National COMMISSION Hearing Science Foundation, 4201 Wilson The evidentiary hearing will Boulevard, Arlington, VA 22230 (703) [Docket No’s. 50–413–OLA, 50–414–OLA; commence the morning of Tuesday, 292–8200. ASLBP No. 03–815–03–OLA] June 15, 2004 at 9 a.m. in the Federal Courthouse, 401 West Trade Street, Purpose of Meeting: To review the Atomic Safety and Licensing Board; NSF assessment of activities under the Charlotte, North Carolina. The hearing Duke Energy Corporation, (Catawba of the above-described evidence will agency’s Organizational Excellence Nuclear Station, Units 1 and 2); Notice strategic goal. continue on June 16 and the morning of of Evidentiary Hearing and Opportunity June 17, 2004, as necessary. At the Agenda: June 15, 2004. Discussion of To Make Limited Appearance conclusion of each day, the Board will NSF’s Organizational Excellence Statements Before Administrative announce when the hearing will strategic goal. Judges: Ann Marshall Young, Chair, reconvene, which will generally be at 9 Dated: March 21, 2004. Anthony J. Baratta, Thomas S. Elleman a.m. each day. The Board may make changes in the schedule, lengthening or Susanne Bolton, May 20, 2004. Committee Management Officer. shortening each day’s session or This Atomic Safety and Licensing canceling a session as deemed necessary [FR Doc. 04–11888 Filed 5–25–04;8:45am] Board hereby gives notice that, or appropriate to allow for witnesses’ BILLING CODE 7555–01–M beginning on Tuesday, June 15, 2004, it availability and other matters arising will convene an evidentiary hearing in during the course of the proceeding. Charlotte, North Carolina, to receive Members of the public are encouraged testimony and exhibits and allow the NATIONAL TRANSPORTATION to attend any and all sessions of this cross-examination of witnesses on SAFETY BOARD evidentiary hearing, but should note certain matters at issue in this that these sessions are adjudicatory Agenda; Sunshine Act Meeting proceeding. In addition, the Board gives proceedings open to the public for notice that, in accordance with 10 CFR observation only. Those who wish to 2.715(a), it will also entertain oral participate are invited to offer limited TIME: 9:30 a.m., Tuesday, June 8, 2004. limited appearance statements from appearance statements as provided in PLACE: NTSB Conference Center, 429 members of the public, as specified in section B, below. There will be security L’Enfant Plaza, SW., Washington, DC section B below. screening for all sessions, and electronic 20594. This proceeding involves certain devices may not be brought into the courthouse. STATUS: The one item is open to the challenges of Intervenor Blue Ridge public. Environmental Defense League (BREDL) B. Participation Guidelines for Limited to a request filed by Duke Energy Appearance Session MATTER TO BE CONSIDERED: 7501A Corporation (Duke) to amend the Aircraft Accident Report—Collision operating license for its Catawba On the evening of June 15, 2004, with Trees on Final Approach, FedEx Nuclear Station to allow the use of four beginning at 6 p.m. and continuing until flight 1478, Boeing 727–232, N497FE, mixed oxide (MOX) lead test assemblies 8 p.m. as necessary, in a portion of the Tallahassee, Florida, July 26, 2002. at the station. (MOX fuel contains a Grand Ballroom (lobby level) of the mixture of plutonium and uranium Omni Charlotte Hotel (132 East Trade NEWS MEDIA CONTACT: Telephone: (202) Street), any persons who are not parties 314–6100. oxides, with plutonium providing the primary fissile isotopes; Duke has to the proceeding will be permitted to make oral statements setting forth their Individuals requesting specific submitted its request as part of the positions on matters of concern relating accommodations should contact Ms. ongoing U.S.-Russian Federation to this proceeding. Although these Carolyn Dargan at (202) 314–6305 by plutonium disposition program, a statements do not constitute testimony Friday, June 4, 2004. nuclear nonproliferation program to or evidence, they may nonetheless help The public may view the meeting via dispose of surplus plutonium from the Board and/or the parties in their a live or archived webcast by accessing nuclear weapons by converting the consideration of the issues in this a link under ‘‘News & Events’’ on the material into MOX fuel and using that proceeding. NTSB home page at http:// fuel in nuclear reactors.) On September www.ntsb.gov. 17, 2003, this Licensing Board was The time allotted for each statement established to preside over this will normally be no more than five FOR FURTHER INFORMATION CONTACT: proceeding. 68 FR 55,414 (Sept. 25, minutes, but may be further limited depending on the number of written Vicky D’Onofrio, (202) 314–6410. 2003). By Memorandum and Order requests to make oral statements that are dated March 5, 2004, the Licensing Dated: May 21, 2004. submitted in accordance with section C Board granted BREDL’s request for Vicky D’Onofrio, below, and/or on the number of persons hearing. LBP–04–04, 59 NRCl(2004). Federal Register Liaison Officer. present the evening of June 15, 2004, [FR Doc. 04–11968 Filed 5–21–04; 5:10 pm] At the June evidentiary hearing, the who wish to make unscheduled BILLING CODE 7533–01–M Board will receive evidence on BREDL’s comments. Persons who submit timely challenges to the adequacy of certain written requests to make oral statements aspects of Duke’s license amendment will be given priority over those who request, relating to asserted differences have not filed such requests. If all in the behavior of MOX fuel and typical scheduled and unscheduled speakers low enriched uranium fuel and the present have made their oral statements impact of those differences on accident prior to 8 p.m., the Licensing Board may scenario analyses for the Catawba plant. terminate the session before 8 p.m.

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C. Submitting Requests To Make an Dated: Rockville, Maryland, May 20, 2004. acceptable results for the long-term Oral Limited Appearance Statement Ann Marshall Young, containment LOCA response with a Chair, Administrative Judge. service water temperature of 94 °F. The To be considered timely, a written [FR Doc. 04–11853 Filed 5–25–04; 8:45 am] NPSH analyses were performed using a request to make an oral statement must ° BILLING CODE 7590–01–P service water temperature of 90 F. The be mailed, faxed, or sent by e-mail so as lower service water temperature, 90 °F, to be received by close of business (4:30 would be operationally controlling. That p.m. e.s.t.) on Monday, June 7, 2004. NUCLEAR REGULATORY is, exceeding a service water Written requests should be submitted to: COMMISSION temperature of 90 °F would exceed the Mail: Office of the Secretary, Monticello licensing basis since the Rulemakings and Adjudications Staff, [Docket No. 50–263] NPSH calculations would no longer be U.S. Nuclear Regulatory Commission, Nuclear Management Company, LLC; valid. The proposed action is in accordance Washington, DC 20555–0001. Monticello Nuclear Generating Plant; with NMC’s application of December 6, Fax: (301) 415–1101 (verification Revised Environmental Assessment 2002, as supplemented September 24, (301) 415–1966). and Finding of No Significant Impact 2003, and March 12, 2004. E-mail: [email protected]. The U.S. Nuclear Regulatory The Need for the Proposed Action In addition, using the same method of Commission (NRC) is considering service, a copy of the written request to issuance of an amendment to Facility NMC needs this license amendment make an oral statement should be sent Operating License No. DPR–22, issued because it has determined, in to the Chair of this Licensing Board as to Nuclear Management Company, LLC accordance with 10 CFR follows: (NMC), for operation of the Monticello 50.59(c)(2)(viii), that the updated Mail: Administrative Judge Ann Nuclear Generating Plant (Monticello), containment analyses involve different Marshall Young, Atomic Safety and located in Wright County, Minnesota. evaluation methods from those Licensing Board Panel, Mail Stop T– Therefore, as required by 10 CFR 51.21, currently described in Monticello’s 3F23, U.S. Nuclear Regulatory the NRC is issuing this revised USAR and previously approved by the Commission, Washington, DC 20555– environmental assessment and finding NRC. 0001. of no significant impact. Environmental Impacts of the Proposed Fax: (301) 415–5599 (verification Revised Environmental Assessment Action (301) 415–7550). The NRC staff reviewed NMC’s Identification of the Proposed Action E-mail: [email protected]. amendment request and will issue a The proposed action would revise the safety evaluation documenting its D. Submitting Written Limited Monticello operating license to change review. The NRC staff has reviewed Appearance Statements the Monticello design bases and the NMC’s calculation of the mass and Updated Safety Analysis Report A written limited appearance energy releases that are used to (USAR). The proposed action would statement may be submitted at any time. determine containment pressure revise the existing analyses for the Such statements should be sent to the response, including the methods and following: key underlying input assumptions (e.g., Office of the Secretary using any of the • Long-term containment response to methods prescribed above, with a copy decay heat generation). the design-basis loss-of-coolant accident NMC used conservative assumptions to the Licensing Board Chair by the (LOCA). in its reanalyses which underestimate same method. • Containment overpressure (the the containment pressure and E. Availability of Documentary pressure above the initial containment overestimate the suppression pool water Information Regarding the Proceeding pressure) required for adequate temperature. Some overpressure is available net positive suction head necessary to ensure sufficient available Documents relating to this proceeding (NPSH) for the low-pressure emergency NPSH. The conservative assumptions are available for public inspection at the core cooling system pumps following a used in NMC’s calculations and the NRC Public Document Room (PDR), LOCA, reactor vessel isolation, or cautions in Monticello’s emergency located at One White Flint North, 11555 Appendix R fire. operating procedures are intended to Rockville Pike (first floor), Rockville, In addition, NMC intends to use these ensure that this pressure will be Maryland; or electronically through the analyses to justify revising the service available. publicly available records component of water temperature licensing basis. NMC The NRC has completed its evaluation the NRC Agencywide Documents administratively limits the service water of the proposed action and concludes, Access and Management System temperature to 85 °F, instead of its as set forth below, that there are no (ADAMS). ADAMS is accessible current licensing basis value of 90 °F, significant environmental impacts through the NRC Web site at http:// because the results of analyses of a new associated with the proposed changes to www.nrc.gov/reading-rm/adams.html. scenario (reactor vessel isolation with the Monticello design basis and USAR. The PDR and many public libraries have high-pressure coolant injection The details of the NRC staff’s review of terminals for public access to the unavailable) showed that the design the amendment request will be provided Internet. Persons who do not have temperature for the piping attached to in the related safety evaluation when it access to ADAMS or who encounter the wetwell would be exceeded. A is issued by the NRC. problems in obtaining access to the license amendment is required since The proposed action will not documents located in ADAMS may NMC used different methods of significantly increase the probability or contact the NRC PDR reference staff by evaluation in the updated containment consequences of accidents, no changes telephone at 1 (800) 397–4209 or (301) analyses from those currently described are being made in the types or amounts 415–4737, or by e-mail to [email protected]. in the Monticello USAR and previously of effluents that may be released off site, For the Atomic Safety and Licensing approved by the NRC. NMC’s submittal and there is no significant increase in Board. of December 6, 2002, demonstrates occupational or public radiation

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exposure. Therefore, there are no Reading Room on the Internet at the Comments on the form should be significant radiological environmental NRC Web site, http://www.nrc.gov/ submitted to the Agency submitting impacts associated with the proposed reading-rm/adams.html. Persons who officer. action. do not have access to ADAMS or who FOR FURTHER INFORMATION CONTACT: With regard to potential encounter problems in accessing the OPIC Agency Submitting Officer: Bruce nonradiological impacts, the proposed documents located in ADAMS, should I. Campbell, Records Management action does not have a potential to affect contact the NRC PDR Reference staff by Officer, Overseas Private Investment any historic sites. It does not affect telephone at 1 (800) 397–4209 or (301) Corporation, 1100 New York Avenue, nonradiological plant effluents and has 415–4737, or by e-mail to [email protected]. NW., Washington, DC 20527; 202/336– no other environmental impact. Dated at Rockville, Maryland, this 20th day 8563. Therefore, there are no significant of May 2004. OMB Reviewer: David Rostker, Office nonradiological environmental impacts For the Nuclear Regulatory Commission. of Information and Regulatory Affairs, associated with the proposed action. L. Raghavan, Office of Management and Budget, New Accordingly, the NRC concludes that Executive Office Building, Docket there are no significant environmental Chief, Section 1, Project Directorate III, Division of Licensing Project Management, Library, Room 10102, 725 17th Street, impacts associated with the proposed Office of Nuclear Reactor Regulation. NW., Washington, DC 20503; 202/395– action. [FR Doc. 04–11854 Filed 5–25–04; 8:45 am] 3897. Environmental Impacts of the BILLING CODE 7590–01–P Summary Form Under Review Alternatives to the Proposed Action Type of Request: Revised form. As an alternative to the proposed Title: Self Monitoring Questionnaire OVERSEAS PRIVATE INVESTMENT action, the staff considered denial of the for Insurance & Finance Projects. CORPORATION proposed action (i.e., the ‘‘no-action’’ Form Number: OPIC–162. alternative). Denial of the application Frequency of Use: Annually for would result in no change in current Agency Report Form Under OMB Review duration of project. environmental impacts. The Type of Respondents: Business or environmental impacts of the proposed AGENCY: Overseas Private Investment other institution (except farms); action and the alternative action are Corporation (OPIC). individuals. similar. ACTION: Request for comments. Description of Affected Public: U.S. Alternative Use of Resources companies or citizens investing SUMMARY: Under the provision of the overseas. The action does not involve the use of Paperwork Reduction Act (44 U.S.C. Reporting Hours: 8.5 hours per any different resource than those Chapter 35), agencies are required to project. previously considered in the Final publish a Notice in the Federal Register Number of Responses: 230 per year. Environmental Statement for Monticello notifying the public that the Agency is Federal Cost: $15,718. dated November 1972. preparing an information collection Authority for Information Collection: Agencies and Persons Consulted request for OMB review and approval Sections 231, 234(a), 239(d), and 240A and to request public review and of the Foreign Assistance Act of 1961, On January 6, 2004, the staff comment on the submission. OPIC as amended. consulted with the Minnesota State published its first Federal Register Abstract (Needs and Uses): The official, Nancy Campbell of the Notice on this information collection questionnaire is completed by OPIC- Department of Commerce, regarding the request on March 22, 2004, at FR 13339, assisted investors annually. The environmental impact of the proposed at which time a 60-day comment period questionnaire allows OPIC’s assessment action. The State official had no was announced. of effects of OPIC-assisted projects on comments. This comment period ended May 21, the U.S. economy and employment, as Finding of No Significant Impact 2004. No comments were received in well as on the environment and economic development abroad. On the basis of the environmental response to this notice. assessment, the NRC concludes that the This information collection Dated: May 21, 2004. proposed action will not have a submission has now been submitted to Eli Landy, significant effect on the quality of the OMB for review. Comments are again Senior Counsel, Administrative Affairs, human environment. Accordingly, the being solicited on the need for the Department of Legal Affairs. NRC has determined not to prepare an information, the accuracy of the [FR Doc. 04–11850 Filed 5–26–04; 8:45 am] Agency’s burden estimate; the quality, environmental impact statement for the BILLING CODE 3210–01–M proposed action. practical utility and clarity of the For further details with respect to the information to be collected; and on proposed action, see NMC’s letter of ways to minimize the reporting burden, OVERSEAS PRIVATE INVESTMENT December 6, 2002, as supplemented including automated collection CORPORATION September 24, 2003, and March 12, techniques and uses of other forms of 2004. Documents may be examined, technology. The proposed form under Submission for OMB Review; and/or copied for a fee, at the NRC’s review, OMB control number 3420– Comment Request 0019, is summarized below. Public Document Room (PDR), located AGENCY: Overseas Private Investment at One White Flint North, Public File DATES: Comments must be received Corporation. within 30 calendar days of publication Area O1 F21, 11555 Rockville Pike (first ACTION: Request for Comments. floor), Rockville, Maryland. Publicly of this Notice. available records will be accessible ADDRESSES: Copies of the subject form SUMMARY: Under the provisions of the electronically from the Agencywide and the request for review prepared for Paperwork Reduction Act (44 U.S.C. Documents Access and Management submission to OMB may be obtained chapter 35), agencies are required to System (ADAMS) Public Electronic from the Agency submitting officer. publish a notice in the Federal Register

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notifying the public that the Agency is of the Foreign Assistance Act of 191, as Securities and Exchange Commission preparing an information collection amended. (‘‘Commission’’), pursuant to Section request for OMB review and approval Abstract (Needs and Uses): The 12(d) of the Securities Exchange Act of and to request public review and questionnaire is completed by OPIC- 1934 (‘‘Act’’)1 and Rule 12d2–2(d) comment on the submission. OPIC assisted investors annually. The thereunder,2 to withdraw its common published its first Federal Register questionnaire allows OPIC’s assessment units (representing limited partnership notice on this information collection of effects of OPIC-assisted projects on interests) (‘‘Security’’), from listing and request on March 22, 2004, in vol. 69, the U.S. economy and employment, as registration on the American Stock no. 55 FR 13340, at which time a 60-day well as on the environment and Exchange LLC (‘‘Amex’’ or ‘‘Exchange’’). comment period was announced. This economic development abroad. The Managing Board of the Issuer’s comment period ended May 21, 2004. Dated: May 21, 2004. general partner (‘‘Board’’) unanimously approved a resolution on May 3, 2004 No comments were received in response Eli Landy, to this notice. to withdraw the Issuer’s Security from Senior Counsel, Administrative Affairs, listing on the Amex, and to list the This information collection Department of Legal Affairs. submission has now been submitted to Security on the New York Stock [FR Doc. 04–11851 Filed 5–25–04; 8:45 am] OMB for review. Comments are again Exchange, Inc. (‘‘NYSE’’). The Board being solicited on the need for the BILLING CODE 3210–01–M states that it is taking such action to information; the accuracy of the avoid the direct and indirect costs, and the division of the market, resulting Agency’s burden estimate; the quality, OVERSEAS PRIVATE INVESTMENT from dual listing on the Amex and practical utility and clarity of the CORPORATION information to be collected; and on NYSE. In addition, the Board ways to minimize the reporting burden, Sunshine Act Meeting; Africa determined that it is in the best interest including automated collection Investment Advisory Council Meeting of the Issuer to list the Security on the techniques and uses of other forms of NYSE. technology. The proposed form, OMB TIME AND DATE: Monday, June 21, 2004, The Issuer stated in its application control number 3420–0023, under 9:30 a.m. (Open Portion); 9:45 a.m. that it has met the requirements of review is summarized below. (Closed Portion). Amex Rule l8 by complying with all DATES: Comments must be received PLACE: Offices of the Corporation, applicable laws in the State of Delaware, within 30 calendar days of this notice. Twelfth Floor Europe Room, 1100 New in which it is incorporated, and with the Amex’s rules governing an issuer’s ADDRESSES: Copies of the subject form York Avenue, NW., Washington, DC. voluntary withdrawal of a security from and the request for review prepared for STATUS: Meeting Open to the Public listing and registration. submission to OMB may be obtained from 9:30 a.m. to 9:45 a.m. Closed The Issuer’s application relates solely from the Agency submitting officer. portion will commence at 9:45 a.m. to the withdrawal of the Security from Comments on the form should be (approx.). listing on the Amex, and shall not affect submitted to the OMB Reviewer. MATTERS TO BE CONSIDERED: its continued listing on the NYSE or its FOR FURTHER INFORMATION CONTACT: 1. Welcome and Introductory obligation to be registered under Section OPIC Agency Submitting Officer: Remarks. 12(b) of the Act.3 Bruce I. Campbell, Records Management FURTHER MATTERS TO BE CONSIDERED: Any interested person may, on or Officer, Overseas Private Investment (Closed to the Public 9:45 a.m.) before June 11, 2004, comment on the Corporation, 1100 New York Avenue, 1. Administrative Issues. facts bearing upon whether the NW., Washington, DC 20527; (202) 336– 2. Reports. application has been made in 8563. CONTACT PERSON FOR INFORMATION: accordance with the rules of the Amex, OMB Reviewer: David Rostker, Officer Information on the meeting may be and what terms, if any, should be of Information and Regulatory Affairs, imposed by the Commission for the Office of Management and Budget, New obtained form Marysue K. Shore at (202) 336–8630. protection of investors. All comment Executive Office Building, Docket letters may be submitted by either of the Library, Room 10102, 725 17th Street, Dated: May 24, 2004. following methods: NW., Washington, DC 20503; (202) 395– Connie M. Downs, Electronic comments: 3897. Corporate Secretary. • Send an e-mail to rule- SUMMARY FORM UNDER REVIEW: [FR Doc. 04–12023 Filed 5–24–04; 12:55 pm] [email protected]. Please include the Type of Request: Revised form. BILLING CODE 3210–07–M File Number 1–14998 or; Title: Self-Monitoring Questionnaire Paper comments: for Investment Funds’ Sub-Projects. • Send paper comments in triplicate Form Number: OPIC–217. SECURITIES AND EXCHANGE to Jonathan G. Katz, Secretary, Frequency of Use: Annually for COMMISSION Securities and Exchange Commission, duration of project. 450 Fifth Street, NW., Washington, DC Type of Respondents: Business or Issuer Delisting; Notice of Application 20549–0609. other institution (except farms); of Atlas Pipeline Partners, L.P., To All submissions should refer to File individuals. Withdraw Its Common Units Number 1–14998. This file number Description of Affected Public: U.S. (Representing Limited Partnership should be included on the subject line companies or citizens investing interests), From Listing and if e-mail is used. To help us process and overseas. Registration on the American Stock review your comments more efficiently, Reporting Hours: 8.5 hours per Exchange LLC, File No. 1–14998 please use only one method. The project. Commission will post all comments on Number of Responses: 189 per year. May 19, 2004. Federal Cost: $12,916. On May 7, 2004, Atlas Pipeline 1 15 U.S.C. 78l(d). Authority for Information Collection: Partners, L.P., a Delaware corporation 2 17 CFR 240.12d2–2(d). Sections 231, 234(a), 239(d), and 240A (‘‘Issuer’’), filed an application with the 3 15 U.S.C. 781(b).

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the Commission’s Internet Web site of the Issuer to list the Security on the For the Commission, by the Division of (http://www.sec.gov/rules/delist.shtml). NYSE. Market Regulation, pursuant to delegated authority.4 Comments are also available for public The Issuer stated in its application inspection and copying in the Jonathan G. Katz, that it has met the requirements of Secretary. Commission’s Public Reference Room, Amex Rule l8 by complying with all 450 Fifth Street, NW., Washington, DC [FR Doc. 04–11840 Filed 5–25–04; 8:45 am] applicable laws in the State of Delaware, 20549. All comments received will be BILLING CODE 8010–01–P in which it is incorporated, and with the posted without change; we do not edit personal identifying information from Amex’s rules governing an issuer’s submissions. You should submit only voluntary withdrawal of a security from SECURITIES AND EXCHANGE information that you wish to make listing and registration. COMMISSION available publicly. The Issuer’s application relates solely [Release No. 34–49736; File No. SR–CHX– The Commission, based on the to the withdrawal of the Security from 2003–21] information submitted to it, will issue listing on the Amex, and shall not affect an order granting the application after its continued listing on the NYSE or its Self-Regulatory Organizations; Order the date mentioned above, unless the obligation to be registered under section Approving Proposed Rule Change and Commission determines to order a 12(b) of the Act.3 Amendment No. 1 and Notice of Filing hearing on the matter. and Order Granting Accelerated Any interested person may, on or Approval to Amendment No. 2 by the For the Commission, by the Division of before June 11, 2004, comment on the Chicago Stock Exchange, Inc., Market Regulation, pursuant to delegated facts bearing upon whether the Relating to the Price Improvement of authority.4 application has been made in Orders Executed Automatically on the Jonathan G. Katz, accordance with the rules of the Amex, Exchange Secretary. and what terms, if any, should be [FR Doc. 04–11841 Filed 5–25–04; 8:45 am] imposed by the Commission for the May 19, 2004. BILLING CODE 8010–01–P protection of investors. All comment I. Introduction letters may be submitted by either of the On July 17, 2003, the Chicago Stock following methods: SECURITIES AND EXCHANGE Exchange, Inc. (‘‘CHX’’ or ‘‘Exchange’’) COMMISSION Electronic comments: filed with the Securities and Exchange • Send an e-mail to rule- Commission (‘‘Commission’’ or ‘‘SEC’’), Issuer Delisting; Notice of Application [email protected]. Please include the pursuant to Section 19(b)(1) of the of Bentley Pharmaceuticals, Inc. To File Number 1–10581 or; Securities Exchange Act of 1934 Withdraw Its Common Stock, $.02 Par (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 a Value, From Listing and Registration Paper comments: proposed rule change to amend CHX on the American Stock Exchange LLC • Send paper comments in triplicate Article XX, Rule 37, to revise the rules File No. 1–10581 to Jonathan G. Katz, Secretary, governing the CHX’s SuperMAX 2000 Securities and Exchange Commission, program. The CHX filed Amendment May 19, 2004. 450 Fifth Street, NW., Washington, DC Nos. 1 and 2 to the proposal on March On May 11, 2004, Bentley 20549–0609. 30, 2004,3 and May 18, 2004,4 Pharmaceuticals Inc., a Delaware All submissions should refer to File respectively. corporation (‘‘Issuer’’), filed an The proposed rule change and application with the Securities and Number 1–10581. This file number Amendment No. 1 were published for Exchange Commission (‘‘Commission’’), should be included on the subject line comment in the Federal Register on pursuant to section 12(d) of the if e-mail is used. To help us process and April 12, 2004.5 The Commission Securities Exchange Act of 1934 review your comments more efficiently, received no comments regarding the (‘‘Act’’) 1 and Rule 12d2–2(d) please use only one method. The proposal. This order approves the thereunder,2 to withdraw its common Commission will post all comments on proposed rule change, as amended. In stock, $.02 par value (‘‘Security’’), from the Commission’s Internet Web site addition, the Commission is publishing listing and registration on the American (http://www.sec.gov/rules/delist.shtml). Stock Exchange LLC (‘‘Amex’’ or Comments are also available for public 4 17 CFR 200.30–3(a)(1). ‘‘Exchange’’). inspection and copying in the 1 15 U.S.C. 78s(b)(1). 2 The Board of Directors (‘‘Board’’) of Commission’s Public Reference Room, 17 CFR 240.19b-4. 450 Fifth Street, NW., Washington, DC 3 See letter from Kathleen M. Boege, Vice the Issuer unanimously approved a President and Associate General Counsel, CHX, to resolution on March 26, 2004 to 20549. All comments received will be Nancy J. Sanow, Division of Market Regulation withdraw the Issuer’s Security from posted without change; we do not edit (‘‘Division’’), Commission, dated March 29, 2004. listing on the Amex, and to list the personal identifying information from 4 See letter from Kathleen M. Boege, Vice President and Associate General Counsel, CHX, to Security on the New York Stock submissions. You should submit only Nancy J. Sanow, Division, Commission, dated May Exchange, Inc. (‘‘NYSE’’). The Board information that you wish to make 18, 2004 (‘‘Amendment No. 2’’). Amendment No. 2 states that it is taking such action to available publicly. revises the proposal to: (1) Indicate that an order must receive the national best bid, or better, or the avoid the direct and indirect costs, and The Commission, based on the the division of the market, resulting national best offer, or better, at the time the order information submitted to it, will issue was received; and (2) clarify that the CHX is from dual listing on the Amex and an order granting the application after deleting CHX Article XX, Rule 37(d)(1)(d) because NYSE. In addition, the Board the CHX intends for CHX Article XXXI to govern the date mentioned above, unless the determined that it is in the best interest the execution prices due odd-lot orders. In addition, Commission determines to order a Amendment No. 2 states that it replaces an earlier hearing on the matter. version of Amendment No. 2 that the CHX filed 4 17 CFR 200.30–3(a)(1). with the Commission on May 12, 2004. 1 15 U.S.C. 78l(d). 5 See Securities Exchange Act Release No. 49530 2 17 CFR 240.12d2–2(d). 3 15 U.S.C. 781(b). (April 6, 2004), 69 FR 19253.

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notice to solicit comments on and is lieu of CHX Article XX, Rule 37(d)(1)(d), in effect at the time the order was simultaneously approving, on an CHX Article XXXI, ‘‘Execution of Odd- received, or better; and (2) clarifying accelerated basis, Amendment No. 2. Lot Orders during the Primary Market that the CHX is deleting CHX Article Trading,’’ will govern the execution XX, Rule 37(d)(1)(d) because the II. Description of the Proposal prices due odd-lot orders.10 Exchange intends for CHX Article XXXI The CHX proposes to amend CHX According to the CHX, SuperMAX to govern the execution prices due odd- Article XX, Rule 37, to revise its rules 2000, which was adopted in 2000,11 lot orders.14 governing the SuperMAX 2000 program. combined five different price III. Discussion SuperMAX 2000 is a program within the improvement programs formerly CHX’s MAX execution system that contained in the CHX’s rules. Each of The Commission finds that the uses a computerized algorithm to the programs was based on factors proposed rule change is consistent with provide automated price improvement including order size and best bid or the requirements of the Act and the to orders executed automatically within offer spread. Largely for marketing rules and regulations thereunder the MAX system. SuperMAX 2000 is a reasons, SuperMAX 2000 contained applicable to a national securities voluntary price improvement program, separate provisions for price exchange 15 and, in particular, with the and CHX specialists may elect to engage improvement of 100-share orders to requirements of Section 6(b)(5) of the SuperMAX 2000 on an issue-by-issue establish a minimum threshold of price Act,16 which requires, among other basis.6 improvement for small orders. things, that the rules of a national Currently, the CHX’s rules provide The CHX believes that separate securities exchange be designed to that in securities for which SuperMAX treatment of 100-share orders is no promote just and equitable principles of 2000 has been enabled: (1) An order for longer warranted and that the trade, to remove impediments to and at least 100 shares will be executed at elimination of special treatment for 100- perfect the mechanism of a free and the ITS Best Offer or NBO (for a buy share orders could reduce confusion. In open market and a national market order) or the ITS Best Bid or NBB (for addition, the CHX believes that it is system, and, in general, to protect a sell order) if the spread in the security appropriate for CHX specialists to investors and the public interest. As at the time the order is received is less exercise the same discretion with described more fully above, the than $.02; (2) an order for 100 shares respect to 100-share orders that they proposal modifies the CHX’s SuperMAX will be executed at a price at least $.01 currently exercise with respect to larger rules to eliminate the requirement that lower than the ITS Best Offer or NBO orders in determining the level of price 100-share orders receive price (for a buy order) or at least $.01 higher improvement that they are willing to improvement of at least $.01 when the than the ITS Best Bid or the NBB (for provide.12 Although the revised rule national best bid or offer spread at the a sell order) if the spread in the security would permit CHX specialists to give time the order is received is at least at the time the order is received is $.02 100-share orders worse execution prices $.02. Under the revised SuperMAX or more; and (3) an order for more than than would be due under the current rules, 100-share orders will receive the 100 shares will be executed at the ITS rule, the Exchange does not believe that same treatment provided currently for Best Offer or NBO, or better, (for a buy the proposal would result in widespread orders of more than 100 shares. Thus, order) or the ITS Best Bid or NBB, or specialist refusal to price improve 100- both 100-share orders and orders of better, (for a sell order) as the specialist share orders.13 Moreover, the CHX notes more than 100 shares will receive the may designate and as is approved by the that even if a number of CHX specialists national best bid or offer in effect at the CHX.7 Thus, for orders of more than 100 time the order was received, or a better declined to price improve 100-share shares, CHX specialists may establish price, as determined by the specialist orders, the CHX’s rules would continue price improvement algorithms to and approved by the CHX. In addition, to obligate CHX specialists to execute provide varying levels of price the proposal will delete the current such orders at a price no worse than the improvement for each issue, based on SuperMAX provisions concerning odd- national best bid or offer. factors including order size, the bid/ lot orders and make clear that CHX Rule On May 18, 2004, the CHX filed offer spread at the time the order is XXXI will govern the execution prices Amendment No. 2 to the proposal. received, and other objective market due odd-lot orders. factors. Amendment No. 2 modifies the The Commission believes that the The CHX proposes to revise proposal by: (1) Revising the text of the proposal should provide CHX SuperMAX 2000 to: (1) Change the proposed rule to indicate that an order specialists with greater flexibility in name of the program to ‘‘SuperMAX;’’ will receive the national best bid or offer determining the level of price (2) provide that any order of 100 shares improvement that they will provide for be executed at the ITS Best Offer or NBO (for a buy or more will receive the ITS Best Bid or order) or the ITS Best Bid or NBB (for a sell order) 100-share orders, as well as for orders of ITS Best Offer in effect at the time the if the spread in the security at the time the order more than 100 shares. Although 100- order was received,8 or better, or the is received is less than $.05. If the spread is $.05 share orders in securities for which NBB or NBO in effect at the time the or greater, the odd-lot order will be executed at a SuperMAX has been enabled no longer price at least $.01 lower than the ITS Best Offer or order was received, or better, as the NBO (for a buy order) or at least $.01 higher than will receive minimum price specialist may designate and as is the ITS Best Bid or NBB (for a sell order). improvement of at least $.01 when the approved by the CHX; and (3) delete 10 See Amendment No. 2, supra note 4. national best bid or offer spread at the CHX Article XX, Rule 37(d)(1)(d), which 11 See Securities Exchange Act Release No. 43742 time the order is received is at least concerns odd-lot orders for which (December 19, 2000), 65 FR 83119 (December 29, $.02, as provided under the current rule, SuperMAX 2000 has been enabled.9 In 2000) (order approving File No. SR–CHX–00–37). the CHX’s rules will continue to require 12 The CHX specialist’s discretion is limited by the CHX Article XX, Rule 37(d)(2), which prohibits the CHX’s specialists to execute 100- 6 The CHX estimates that SuperMAX 2000 is changing SuperMAX 2000 price improvement enabled for over 90% of the issues traded on the parameters more than once per month. 14 See Amendment No. 2, supra note 4. CHX. 13 In this regard, the CHX believes that specialist 15 In approving this proposal, the Commission has 7 See CHX Article XX, Rule 37(d)(1). business considerations, including competitive considered the proposed rule’s impact on 8 See Amendment No. 2, supra note 4. forces in the securities markets, may dictate that efficiency, competition, and capital formation. 15 9 Under CHX Rule XX, Article 37(d)(1)(d), an odd- CHX specialists continue to price improve most U.S.C. 78c(f). lot order in which SuperMAX 2000 is enabled will 100-share orders. 16 15 U.S.C. 78f(b)(5).

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share orders at a price no worse than the finds that it is consistent with Sections V. Conclusion national best bid or offer in effect at the 6(b)(5) and 19(b) of the Act to approve It is therefore ordered, pursuant to time the order was received. In addition, Amendment No. 2 on an accelerated Section 19(b)(2) of the Act,21 that the CHX specialists may continue to offer basis. proposed rule change (SR–CHX–2003– price improvement for 100-share orders. 21), as amended , is approved. Notwithstanding the foregoing, the IV. Solicitation of Comments Commission cautions that the duty of For the Commission, by the Division of Interested persons are invited to Market Regulation, pursuant to delegated best execution requires a broker-dealer authority.22 to seek the most favorable terms submit written data, views, and Margaret H. McFarland, reasonably available under the arguments concerning Amendment No. circumstances for a customer’s 2, including whether Amendment No. 2 Deputy Secretary. transaction.17 A broker-dealer’s duty of is consistent with the Act. Comments [FR Doc. 04–11842 Filed 5–25–04; 8:45 am] best execution is not necessarily may be submitted by any of the BILLING CODE 8010–01–P satisfied by routing orders to a market following methods: center that merely guarantees an Electronic comments: SECURITIES AND EXCHANGE execution at the national best bid or • Use the Commission’s Internet 18 COMMISSION offer. Various markets and market comment form (http://www.sec.gov/ makers may provide opportunities for [Release No. 34–49728; File No. SR–CHX– rules/sro.shtml); or executions at prices superior to the 2004–15] national best bid and offer. The • Send an e-mail to rule- Commission believes that broker-dealers [email protected]. Please include File Self-Regulatory Organizations; Notice deciding where to route or execute Number SR–CHX–2003–21 on the of Filing and Immediate Effectiveness small customer orders must carefully subject line. of a Proposed Rule Change by The evaluate the extent to which this order Chicago Stock Exchange, Inc. To Set Paper comments: Fees for Member Firms for Computer flow would be afforded better terms if • executed in a market or with a market Send paper comments in triplicate Hardware Stored on the Exchange maker offering price improvement to Jonathan G. Katz, Secretary, Premises and for the Connection of that Hardware to the CHX System opportunities. In conducting the Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC requisite evaluation of its internal order May 19, 2004. 20549–0609. handling procedures, a broker-dealer Pursuant to Section 19(b)(1) of the must regularly and rigorously examine All submissions should refer to File Securities Exchange Act of 1934 execution quality likely to be obtained Number SR–CHX–2003–21. This file (‘‘Act’’),1 and Rule 19b–4 thereunder,2 from the different markets or market number should be included on the notice is hereby given that on April 30, makers trading a security.19 subject line if e-mail is used. To help the 2004, the Chicago Stock Exchange, Inc. With respect to odd-lots, because the Commission process and review your (‘‘CHX’’ or ‘‘Exchange’’) filed with the CHX intends for CHX Article XXXI to comments more efficiently, please use Securities and Exchange Commission govern the execution of odd-lot orders,20 only one method. The Commission will (‘‘Commission’’) the proposed rule the Commission believes that deleting post all comments on the Commission’s change as described in Items I, II and III CHX Rule Article XX, Rule 37(d)(1)(d), Internet Web site (http://www.sec.gov/ below, which Items have been prepared will clarify the CHX’s rules and rules/sro.shtml). Copies of the by the Exchange. The CHX has eliminate potential confusion submission, all subsequent designated this proposal as one concerning the execution prices due to amendments, all written statements establishing or changing a due, fee, or odd-lot orders. with respect to the proposed rule other charge imposed by the CHX under The Commission finds good cause for 3 change that are filed with the Section 19(b)(3)(A)(ii) of the Act, approving Amendment No. 2 prior to which renders the proposal effective the thirtieth day after the date of Commission, and all written communications relating to the upon filing with the Commission. The publication of notice of filing thereof in Commission is publishing this notice to proposed rule change between the the Federal Register. Amendment No. 2 solicit comments on the proposed rule Commission and any person, other than clarifies the proposal by indicating that change from interested persons. an order must receive the national best those that may be withheld from the bid or offer in effect at the time the order public in accordance with the I. Self-Regulatory Organization’s was received, and by stating that the provisions of 5 U.S.C. 552, will be Statement of the Terms of Substance of CHX intends for CHX Article XXXI to available for inspection and copying in the Proposed Rule Change govern the execution prices due odd-lot the Commission’s Public Reference The Exchange proposes to amend its orders. Accordingly, the Commission Section, 450 Fifth Street, NW, membership dues and fees schedule (the Washington, DC 20549. Copies of such ‘‘Fee Schedule’’) to charge member 17 See, e.g., Securities Exchange Act Release Nos. filing also will be available for firms a fee for computer hardware 37619A (September 6, 1996), 61 FR 48290 inspection and copying at the principal stored on Exchange premises, and for (September 12, 1996) (adopting Exchange Act Rule the connection of that hardware to CHX 11Ac1–4 and amending Exchange Act Rule 11Ac1– office of the CHX. All comments 1) (‘‘Order Handling Rules Release’’) at Section received will be posted without change; systems, where that hardware is III.C.2. the Commission does not edit personal associated with systems that are used 18 See, e.g., Order Handling Rules Release at identifying information from solely for any purpose other than III.C.2. and Securities Exchange Act Release No. transmitting orders to the Exchange for 42450 (February 23, 2000), 65 FR 10577 (February submissions. You should submit only 28, 2000) (notice of filing of SR–NYSE–99–48 and information that you wish to make Commission request for comment on issues relating available publicly. All submissions 21 15 U.S.C. 78s(b)(2). 22 to market fragmentation) at Section IV.A.3.c. should refer to File Number SR–CHX– 17 CFR 200.30–3(a)(12). 19 See Order Handling Rule Release, supra note 17 1 15 U.S.C. 78s(b)(1). at Section III.C.2. 2003–21 and should be submitted on or 2 17 CFR 240.19b–4. 20 See Amendment No. 2, supra note 4. before June 16, 2004. 3 15 U.S.C. 78s(b)(3)(A)(ii).

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execution. The text of the proposed rule time fee associated with the initial Comments may be submitted by any of change is available at the Commission installation of the hardware or the following methods: and the CHX. connection, as well as a monthly cost Electronic comments: for the period that the hardware or II. Self-Regulatory Organization’s • connection remains in place. These fee Use the Commission’s Internet Statement of the Purpose of, and comment form (http://www.sec.gov/ Statutory Basis for, the Proposed Rule changes are designed to take effect May 1, 2004. rules/sro.shtml); or Change • 2. Statutory Basis Send an e-mail to rule- In its filing with the Commission, the [email protected]. Please include File Exchange included statements The Exchange believes the proposal is Number SR–CHX–2004–15 on the concerning the purpose of, and basis for, 5 consistent with Section 6(b) of the Act, subject line. the proposed rule change and discussed in general and Section 6(b)(4) of the any comments it received on the Act,6 in particular, in that it provides for Paper comments: proposed rule change. The text of these the equitable allocation of reasonable • Send paper comments in triplicate statements may be examined at the dues, fees and other charges among its to Jonathan G. Katz, Secretary, places specified in Item IV below. The members. Securities and Exchange Commission, Exchange has prepared summaries, set B. Self-Regulatory Organization’s 450 Fifth Street, NW., Washington, DC forth in Sections A, B and C below, of 20549–0609. the most significant aspects of such Statement of Burden on Competition statements. The Exchange does not believe that All submissions should refer to File the proposed rule change will impose Number SR–CHX–2004–15. This file A. Self-Regulatory Organization’s any inappropriate burden on number should be included on the Statement of the Purpose of, and competition. subject line if e-mail is used. To help the Statutory Basis for, the Proposed Rule Commission process and review your Change C. Self-Regulatory Organization’s comments more efficiently, please use Statement on Comments Regarding the 1. Purpose only one method. The Commission will Proposed Rule Change Received From post all comments on the Commission’s Many of the Exchange’s member firms Members, Participants or Others use automated systems that interact Internet Web site (http://www.sec.gov/ either with their own posts on the floor No written comments were either rules/sro.shtml). Copies of the or with the posts of other trading floor solicited or received with respect to the submission, all subsequent members. These systems might be used proposed rule change. amendments, all written statements to help members manage their positions, III. Date of Effectiveness of the with respect to the proposed rule to automate the execution of orders that Proposed Rule Change and Timing for change that are filed with the would otherwise be handled manually, Commission Action Commission, and all written communications relating to the to act as a layoff vendor by coordinating The proposed rule change has become the routing of orders to another market effective pursuant to Section proposed rule change between the or for a variety of other purposes. These 19(b)(3)(A)(ii) of the Act,7 and Rule Commission and any person, other than systems are linked to the Exchange’s 19b–4(f)(2) 8 thereunder, because it those that may be withheld from the own systems through various data establishes or changes a due, fee or public in accordance with the connections. In some cases, member other charge imposed by the Exchange. provisions of 5 U.S.C. 552, will be firms also store hardware associated At any time within 60 days of the filing available for inspection and copying in with these systems in the Exchange’s of the proposed rule change, the the Commission’s Public Reference computer facilities. Commission may summarily abrogate Section, 450 Fifth Street, NW., The Exchange believes that it is such rule change if it appears to the Washington, DC 20549–0609. Copies of appropriate to share, with member Commission that such action is such filing also will be available for firms, the costs of providing both this necessary or appropriate in the public inspection and copying at the principal equipment storage and the various data interest, for the protection of investors, office of the CHX. All comments connections to the Exchange’s systems. or otherwise in furtherance of the received will be posted without change; This fee proposal would establish a purposes of the Act. series of fees applicable to the storage of the Commission does not edit personal hardware, and the maintenance of IV. Solicitation of Comments identifying information from submissions. You should submit only connections to CHX systems, for Interested persons are invited to member-owned systems that are solely information that you wish to make submit written data, views, and available publicly. used for any purpose other than arguments concerning the foregoing, transmitting orders to the Exchange for including whether the proposed rule All submissions should refer to File 4 execution. These fees include a one- change is consistent with the Act. Number SR–CHX–2004–15 and should be submitted on or before June 16, 2004. 4 The Exchange’s members request from time to on their non-member status. Therefore, these fees time, that the Exchange allow other market centers For the Commission, by the Division of do not apply to hardware owned and stored in CHX to establish direct linkages to the Exchange’s floor Market Regulation, pursuant to delegated facilities by members that are market centers, or to so that members can transmit orders to other 9 the data connections associated with that hardware. authority. markets. These linkage systems are available to all Telephone conversation between Ellen Neely, CHX specialists and floor brokers that contract with Margaret H. McFarland, Senior Vice President and General Counsel, CHX each market center. The Exchange believes that and Ian Patel, Special Counsel, and Marisol Deputy Secretary. these direct connections provide cost-effective and Rubecindo, Law Clerk, Division of Market efficient mechanisms that link the Exchange’s [FR Doc. 04–11880 Filed 5–25–04; 8:45 am] Regulation, Commission, dated May 17, 2004. members with other markets. However, since only BILLING CODE 8010–01–P 5 one of these market centers is a member of the CHX, 15 U.S.C. 78f(b). the Exchange believes that it would be 6 15 U.S.C. 78f(b)(4). inappropriate to impose these fees on one market 7 15 U.S.C. 78s(b)(3)(A)(ii). center, while other market centers are exempt based 8 17 CFR 240.19b–4(f)(2). 9 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE National Market Execution System (2) Either a non-tape, non-clearing COMMISSION (‘‘NNMS’’), as permitted by Rule 4720. report or a clearing-only report marked with a ‘‘riskless principal’’ capacity 4632. Transaction Reporting [Release No. 34–49733; File No. SR–NASD– indicator. 2004–034] * * * * * (e) Transactions Not Required To Be Self-Regulatory Organizations; Notice (c) Information To Be Reported Reported of Filing and Immediate Effectiveness Each last sale report shall contain the The following types of transactions of Proposed Rule Change and following information: shall not be reported: Amendment No. 1 Thereto by the * * * * * (1) Transactions executed through National Association of Securities (6) For any transaction in an order for [the Nasdaq National Market Execution Dealers, Inc. To Allow Members To which a member has recording and System (‘‘]NNMS[’’), the Primex Report Certain Trades Through reporting obligations under Rules 6954 Auction System, or the SelectNet SuperMontage and 6955, the trade report must include: service]; May 19, 2004. (A) An order identifier, meeting such * * * * * parameters as may be prescribed by the Pursuant to Section 19(b)(1) of the Association, assigned to the order that 4640. Reporting Transactions in Securities Exchange Act of 1934 uniquely identifies the order for the date Nasdaq SmallCapSM Market Securities (‘‘Act’’),1 and Rule 19b–4 thereunder,2 it was received (see Rule 6954(b)(1)). This Rule 4640 Series sets forth the notice is hereby given that on February (B) The time of the execution 26, 2004, the National Association of requirements for reporting transactions expressed in hours, minutes, and SM Securities Dealers, Inc. (‘‘NASD’’), in Nasdaq SmallCap Market securities seconds. This information must be (‘‘designated securities’’) utilizing the through its subsidiary, The Nasdaq reported regardless of the period of time Stock Market, Inc. (‘‘Nasdaq’’), Automated Confirmation Transaction between execution of the trade and the Service (ACT) or the Nasdaq National submitted to the Securities and ACT or NNMS trade report. All times Exchange Commission (‘‘Commission’’) Market Execution System (‘‘NNMS’’), as reported to the ACT or NNMS systems permitted by Rule 4720. the proposed rule change as described shall be in Eastern Time. in Items I, II, and III below, which Items 4642. Transaction Reporting have been prepared by Nasdaq. Nasdaq (d) Procedures for Reporting Price and filed the proposal pursuant to Section Volume * * * * * 19(b)(3)(A) of the Act,3 and Rule 19b– Members that are required, or have (c) Information To Be Reported 4 4(f)(5) thereunder, which renders the the option, to report transactions using Each last sale report shall contain the proposal effective upon filing with the ACT or NNMS, pursuant to paragraph following information: Commission. Nasdaq filed Amendment (b) above shall transmit last sale reports No. 1 to the proposed rule change on * * * * * for all purchases and sales in designated (6) For any transaction in an order for April 27, 2004.5 The Commission is securities in the following manner: which a member has recording and publishing this notice to solicit * * * * * reporting obligations under Rules 6954 comments on the proposed rule change (B) Exception: A ‘‘riskless’’ principal and 6955, the trade report must include: from interested persons. transaction in which a member, after (A) An order identifier, meeting such I. Self-Regulatory Organization’s having received an order to buy a parameters as may be prescribed by the Statement of the Terms of Substance of security, purchases the security as Association, assigned to the order that the Proposed Rule Change principal at the same price to satisfy the uniquely identifies the order for the date order to buy or, after having received an Nasdaq proposes to allow members to it was received (see Rule 6954(b)(1)). order to sell, sells the security as (B) The time of execution expressed report certain trades through the Nasdaq principal at the same price to satisfy the in hours, minutes, and seconds. This National Market Execution System order to sell, shall be reported as one information must be reported regardless (‘‘SuperMontage’’). New text is transaction in the same manner as an of the period of time between execution italicized. Deleted text is in brackets. agency transaction, excluding the mark- of the trade and the ACT or NNMS trade * * * * * up or mark-down, commission- report. All times reported to the ACT or 4630. Reporting Transactions in equivalent, or other fee. Alternatively, a NNMS systems shall be in Eastern Time. Nasdaq National Market Securities member may report a riskless principal transaction by submitting the following (d) Procedures for Reporting Price and This Rule 4630 Series applies to the report(s) to ACT or NNMS: Volume* reporting by members of transactions in * * * * * Members that are required, or have Nasdaq National Market securities Example: the option, to report transactions using (‘‘designated securities’’) through the SELL as a principal 100 shares to ACT or NNMS, pursuant to paragraph Automated Confirmation Transaction another member at 40 to fill an existing (b) above shall transmit last sale reports Reporting Service (ACT) or the Nasdaq order; for all purchases and sales in designated BUY as principal 100 shares from a securities in the following manner: 1 15 U.S.C. 78s(b)(1). customer at 40 minus a mark-down of 2 17 CFR 240.19b–4. * * * * * 3 $12.50; (B) Exception: A ‘‘riskless’’ principal 15 U.S.C. 78s(b)(3)(A). REPORT 100 shares at 40 by 4 17 CFR 240.19b–4(f)(5). transaction in which a member, after 5 See letter from Peter R. Geraghty, Associate Vice submitting to ACT or NNMS either a having received an order to buy a President and Associate General Counsel, Nasdaq, single trade report marked with a security, purchases the security as to Katherine England, Assistant Director, Division ‘‘riskless principal’’ capacity indicator principal at the same price to satisfy the of Market Regulation, Commission, dated April 26, or by submitting the following reports: 2004 (‘‘Amendment No. 1’’). In amendment No. 1, order to buy or, after having received an Nasdaq provided additional description of the (1) Where required by this Rule, a proposed rule change but did not amend the tape report marked with a ‘‘principal’’ * For examples of reporting procedures, refer to proposed rule text. capacity indicator; and Rule 4632, Transaction Reporting.

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order to sell, sells the security as uniquely identifies the order for the date established as appropriate by the principal at the same price to satisfy the it was received (see Rule 6954 (b)(1)). Association. The extent of participation order to sell, shall be reported as one (B) The time of the execution in Nasdaq by an NNMS Order Entry transaction in the same manner as an expressed in hours, minutes, and Firm shall be determined solely by the agency transaction, excluding the mark- seconds. This information must be firm in the exercise of its ability to enter up or mark-down, commission- reported regardless of the period of time orders into Nasdaq. equivalent, or other fee. Alternatively, a between execution of the trade and the * * * * * member may report a riskless principal ACT or NNMS trade report. All times transaction by submitting the following reported to the ACT or NNMS systems 4711. Clearance and Settlement report(s) to ACT or NNMS: shall be in Eastern Time. All transactions executed in, or * * * * * (d) Procedures for Reporting Price and reported through, NNMS shall be Example: Volume* cleared and settled through a registered SELL as a principal 100 shares to clearing agency using a continuous net Members that are required, or have another member at 40 to fill an existing settlement system. the option, to report transactions using order; ACT or NNMS, pursuant to paragraph * * * * * BUY as principal 100 shares from a (b) above shall transmit last sale reports customer at 40 minus a mark-down of 4720. Reporting Through NNMS for all purchases and sales in designated $12.50; securities in the following manner: Subject to the conditions set forth REPORT 100 shares at 40 by below, members may utilize NNMS to * * * * * submitting to ACT or NNMS either a report trades in NNMS eligible securities single trade report marked with a (B) Exception: A ‘‘riskless’’ principal transaction in which a member, after required or eligible to be reported to ‘‘riskless principal’’ capacity indicator Nasdaq pursuant to the Rule 4630, or by submitting the following reports: having received an order to buy a security, purchases the bond as 4640, 4650 and 6100 Series. (1) Where required by this Rule, a (1) Members shall include the time of tape report marked with a ‘‘principal’’ principal at the same price to satisfy the order to buy or, after having received an execution on reports submitted to capacity indicator; and NNMS; and (2) Either a non-tape, non-clearing order to sell, sells the bond as principal report or a clearing-only report marked at the same price to satisfy the order to (2) For transactions between with a ‘‘riskless principal’’ capacity sell, shall be reported as one transaction members, the members who are parties indicator. in the same manner as an agency to the trade shall agree to all trade transaction, excluding the mark-up or details prior to submitting the report to (e) Transactions Not Required To Be mark-down, commission-equivalent, or NNMS, and have in effect and on file Reported other fee. Alternatively, a member may with Nasdaq, an Automated The following types of transactions report a riskless principal transaction by Confirmation Transaction Service shall not be reported: submitting the following report(s) to Service Bureau/Executing Broker (1) Transactions executed through ACT or NNMS: Supplement to the Nasdaq Workstation NNMS [the SmallCap Small Order Example: II Agreement (‘‘Attachment 2 Execution System (SOES), the Primex SELL as a principal 100 shares to Agreement’’), and a Nasdaq National Auction System, or the SelectNet another member at 40 to fill an existing Market Execution System Give-Up service]. order; Addendum to the Nasdaq Workstation II BUY as principal 100 shares from a Subscriber Agreement (‘‘SuperMontage * * * * * customer at 40 minus a mark-down of Give-Up Agreement’’). 4650. Reporting Transactions in $12.50; 5400. NASDAQ STOCK MARKET AND Nasdaq Convertible Debt Securities REPORT 100 shares at 40 by submitting to ACT or NNMS either a ALTERNATIVE DISPLAY FACILITY This Rule 4650 Series sets forth the single trade report marked with a TRADE REPORTING applicable reporting requirements for ‘‘riskless principal’’ capacity indicator 5410. Applicability transactions in convertible bonds that or by submitting the following reports: are listed on Nasdaq (designated (1) where required by this Rule, a tape (a) For a period of time, NASD will securities) and reported utilizing the report marked with a ‘‘principal’’ operate two facilities for collecting trade Automated Confirmation Transaction capacity indicator; and reports for executions in Nasdaq Service (ACT) or the Nasdaq National (2) either a non-tape, non-clearing National Market, Nasdaq SmallCap Market Execution System (‘‘NNMS’’), as report or a clearing-only report marked Market, and Nasdaq Convertible Debt permitted by Rule 4720. with a ‘‘riskless principal’’ capacity securities (‘‘designated securities’’): The Nasdaq Stock Market and the 4652. Transaction Reporting indicator. * * * * * Alternative Display Facility (‘‘ADF’’). * * * * * Nasdaq will continue to operate the 4710. Participant Obligations in NNMS (c) Information To Be Reported Automated Confirmation Transaction (a) Registration—Upon the Service (‘‘ACT’’) and the Nasdaq Each last sale report shall contain the effectiveness of registration as a NNMS National Market Execution System following information: Market Maker, NNMS ECN, or NNMS (‘‘NNMS’’), and NASD, through the * * * * * Order Entry Firm, the NNMS Participant ADF, will operate Trade Reporting and (6) For any transaction in an order for may commence activity within NNMS Comparison Service (‘‘TRACS’’). This which a member has recording and for exposure to orders, [or] entry of Rule 5400 Series establishes the rules reporting obligations under Rules 6954 orders, or to report trades, as applicable. for determining which member must and 6955, the trade report must include: The operating hours of NNMS may be report a trade and whether a trade must (A) An order identifier, meeting such be reported to ACT or NNMS (as parameters as may be prescribed by the * For examples of reporting procedures, refer to permitted by Rule 4720), pursuant to the Association, assigned to the order that Rule 4632, Transaction Reporting. Rule 4630, 4640, 4650 and 6100 Series

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or TRACS, pursuant to the Rule 4630A (B) A Registered Reporting ADF network that is a [member] participant and 6100A Series. Market Maker shall report the trade of a registered clearing agency for (b) The requirements of this Rule 5400 using TRACS; and clearing or comparison purposes or has Series are in addition to the trade (C) A Non-Registered Reporting a clearing arrangement with such a reporting requirements contained in Member shall report the trade using [member] participant, to the extent that Rule Series 4630, 4640, 4650, 6100, ACT, NNMS, or TRACS. transactions executed through it are 4630A and 6100A Series, and Rule (5) In transactions between two reported to ACT or NNMS. 4720. Registered Reporting ADF Market Makers, the member representing the 6130. Trade Report Input 5430. Transaction Reporting sell side shall report the trade using (a) Reportable ACT Transactions (a) When and How Transactions Are TRACS. Reported (6) In transactions between a With the exception of those trades reported to Nasdaq through the Nasdaq * * * * * Registered Reporting ADF Market Maker (2) Non-Registered Reporting and a Non-Registered Reporting National Market Execution System ‘‘ Members shall, within 90 seconds after Member, the Registered Reporting ADF ‘‘NNMS’’ (as permitted by Rule 4720), execution, transmit through ACT, Market Maker shall report the trade [M]members shall utilize ACT to report NNMS or TRACS, as applicable, or if using TRACS. transactions that are required to be ACT, NNMS or TRACS is unavailable (7) In transactions between a reported to Nasdaq pursuant to the Rule due to system or transmission failure, by Registered Reporting Nasdaq Market Series 4630, 4640, 4650, 5430, 6400, telephone to Market Operations Maker and a Registered Reporting ADF 6500 and 6600 Series, including Department, last sale reports of Market Maker, the member representing executions of less than one round lot if transactions in designated securities the sell side shall report as follows: those executions are to be compared and executed during normal market hours. (A) A Registered Reporting Nasdaq locked-in. Members may utilize ACT to Transactions not reported within 90 Market Maker shall report the trade report transactions that are eligible to be seconds after execution shall be using ACT or NNMS; and reported to Nasdaq pursuant to Rule designated as late and such trade reports (B) A Registered Reporting ADF 5430, including executions of less than must include the time of execution. Market Maker shall report the trade one round lot if those executions are to using TRACS. be compared and locked-in. * * * * * (8) If a member simultaneously is a (5) All members shall report as soon Members also may utilize NNMS to Registered Reporting Nasdaq Market as practicable to the Market Regulation report transactions that are eligible to be Maker and a Registered Reporting ADF Department on Form T, last sale reports reported to Nasdaq pursuant to Rule Market Maker, and has the trade of transactions in designated securities 5430, including executions of less than reporting obligation pursuant to for which electronic submission into one round lot if those executions are paragraphs (1), (2), (4), (5), (6), or (7), the ACT, NNMS or TRACS is not possible locked-in. All trades that are reportable member can report the trade using (e.g., the ticker symbol for the security transactions will be processed through either ACT or NNMS, or TRACS, unless is no longer available or a market the National Trade Reporting System; the trade is executed using ACES or [the participant identifier is no longer however, only those trades that are Nasdaq National Market Execution active). Transactions that can be subject to regular way settlement and System (‘‘]NNMS[’’)]. A trade executed reported into ACT, NNMS or TRACS, are not already locked-in trades will be using ACES must be reported using ACT whether on trade date or on a compared and locked-in through ACT. or NNMS, and trades executed using subsequent date on an ‘‘as of’’ basis (T Trades that are reported as other than NNMS will be reported to ACT + N), shall not be reported on Form T. regular way settlement (i.e., Cash, Next- automatically. Day, Seller’s Option) will not be * * * * * (9) In transactions conducted through compared in ACT or reported to NSCC. (b) Which Party Reports Transaction an ACT/NNMS ECN (as defined in Rule All transactions in Direct Participation and to Which Facility 6110) that are reported to ACT or Program securities shall be reported to NNMS, the ACT/NNMS ECN shall (1) In transactions between two ACT pursuant to the Rule 6900 Series as ensure that transactions are reported in Registered Reporting Nasdaq Market set forth therein. accordance with Rule 6130(c). If an Makers, the member representing the * * * * * ACT/NNMS ECN is also a Registered sell side shall report the trade using Reporting ADF ECN (as defined in Rule (c) Which Party Inputs Trade Reports to ACT or NNMS. 4200A), Rule 6130(c) shall apply only to ACT (2) In transactions between a transactions conducted through the ECN Registered Reporting Nasdaq Market for which trade reports are submitted to ACT Participants shall, subject to the Maker and a Non-Registered Reporting ACT or NNMS. input requirements below, either input Member, the Registered Reporting (10) Nasdaq will append the .T trade reports into the ACT system or Nasdaq Market Maker shall report the modifier or the .SLD modifier, as utilize the Browse feature to accept or trade using ACT or NNMS. appropriate, to those reports submitted decline a trade within the applicable (3) In transactions between two Non- time-frames as specified in paragraph Registered Reporting Members, the to ACT or NNMS that contain the time of execution, but that do not contain the (b) of this Rule. Trade data input member representing the sell side shall obligations are as follows: report the trade using ACT, NNMS, or appropriate modifier. * * * * * TRACS. 6100. AUTOMATED CONFIRMATION (4) In transactions between a member TRANSACTION SERVICE (ACT) (5) in transactions conducted through and a customer, the member shall report an ACT/NNMS ECN that are reported to 6110. Definitions as follows: ACT or NNMS, the ACT/NNMS ECN (A) A Registered Reporting Nasdaq (q) The term ‘‘ACT/NNMS ECN’’ shall shall ensure that transactions are Market Maker shall report the trade mean a member of the Association that reported in accordance with one of the using ACT or NNMS; is an electronic communications following methods:

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(A) The ACT/NNMS ECN shall submit accordance with the requirements of summaries, set forth in sections A, B, the trade reports to ACT or NNMS and subparagraph (5)(A) above. and C below, of the most significant identify itself as the reporting party; * * * * * aspects of such statements. (B) The ACT/NNMS ECN shall submit the trade reports to ACT or NNMS on 6400. REPORTING TRANSACTIONS A. Self-Regulatory Organization’s behalf of the reporting party and IN LISTED SECURITIES Statement of the Purpose of, and identify the reporting party in * * * * * Statutory Basis for, the Proposed Rule accordance with the rules for Change 6420. Transaction Reporting determining reporting parties reflected 1. Purpose in paragraphs (1), (2), (3), and (4) above; * * * * * or (b) Which Party Reports Transaction Nasdaq proposes to provide members (C) The ACT/NNMS ECN shall require the ability to use SuperMontage to one of the parties, determined in (5) In transactions conducted through report trades in Nasdaq National Market accordance with the rules for an ACT/NNMS ECN (as defined in Rule and SmallCap Market securities determining reporting parties reflected 6110), the ACT/NNMS ECN shall ensure (‘‘Nasdaq securities’’) that they have in paragraphs (1), (2), (3), and (4) above, that the transactions are reported in matched outside of any system operated accordance with Rule 6130(c). to submit the trade reports to ACT or by a self-regulatory organization. Today NNMS. 6600. OVER-THE-COUNTER EQUITY when a member matches orders in its When an ACT/NNMS ECN reports SECURITIES own system it can report the trade to transactions in accordance with * * * * * Nasdaq’s Automated Confirmation subparagraph (A), the ACT/NNMS ECN Transaction Service (‘‘ACT’’). Under shall be responsible for ensuring that 6620. Transaction Reporting this proposal, members now will be able the trade reports are accurate and * * * * * to report matched trades in Nasdaq contain all information required by securities to SuperMontage. subsection (d) of this rule for both the (b) Which Party Reports Transactions SuperMontage will transmit the ACT/NNMS ECN and the identified * * * * * information to ACT, where it will be non-reporting party. When an ACT/ (5) In transactions conducted through processed as any other information NNMS ECN reports transactions in an ACT/NNMS ECN (as defined in Rule submitted to that system. For example, accordance with subparagraph (B), both 6110), the ACT/NNMS ECN shall ensure the trade information will be the ACT/NNMS ECN and the party that the transactions are reported in disseminated on the consolidated tape identified as the reporting party shall be accordance with Rule 6130(c), and the and included in ACT risk management responsible for ensuring that the trade term ‘‘Market Maker’’ as used in such calculations and Nasdaq’s audit trail. In reports are accurate and contain all rule shall be construed to refer to an addition, the trades will be submitted to information required by subsection (d) OTC Market Maker. the National Securities Clearing of this rule for both the ACT/NNMS 6900. REPORTING TRANSACTIONS Corporation (‘‘NSCC’’) for clearing, if ECN and the identified reporting party. IN DIRECT PARTICIPATION necessary. Trades reported to When an ACT/NNMS ECN requires PROGRAMS SuperMontage will not be included in reporting of transactions in accordance * * * * * the SuperMontage execution algorithm, with subparagraph (C), the reporting and thus will not interact with any party shall be responsible for ensuring 6920. Transaction Reporting quotes or orders in the system. the accuracy and completeness of the trade report. (b) Which Party Reports Transactions Members will not be permitted to An ACT/NNMS ECN shall provide * * * * * report through SuperMontage trades for written notice to the Association of the (3) In transactions conducted through which the details have not already been method of trade reporting used by the an ACT/NNMS ECN (as defined in Rule compared and agreed to by the parties ACT/NNMS ECN for each of its 6110), the ACT/NNMS ECN shall ensure to the trade. This limitation is necessary subscribers, and may change the method that the transactions are reported in because SuperMontage will not have the of trade reporting used for a subscriber accordance with Rule 6130(c); provided same functionality as ACT that allows by providing advance written notice of that for purposes of Rule 6130(c)(5) (B) one party to submit the trade details and the change to the Association; and (C), the party with the reporting the other party to review the (6) In transactions conducted through obligation shall be as set forth in Rule information and affirmatively agree to two ACT/NNMS ECNs or an ACT/ 6130(c)(3) and the term ‘‘Order Entry the trade, or the functionality that NNMS ECN and an ECN that is not an Firm’’ as used in such rule shall be allows ACT to compare the information ACT/NNMS ECN, an ACT/NNMS ECN construed to refer to any member. submitted by each party to the trade. shall be responsible for complying with * * * * * Members that desire to report trades the requirements of paragraph (5) above using either of these methods must for reporting a transaction executed II. Self-Regulatory Organization’s continue to submit reports directly to through its facilities, and an ECN that Statement of the Purpose of, and ACT. routed an order to it for execution shall Statutory Basis for, the Proposed Rule Change As a result, SuperMontage will accept be deemed to be an Order Entry Firm only: (1) Tape-only reports; 6 (2) locked- and a member for purposes of the rules In its filing with the Commission, for determining reporting parties Nasdaq included statements concerning 6 A ‘‘tape-only report’’ is a trade that is reported reflected in paragraphs (1), (3), and (4) the purpose of, and basis for, the to Nasdaq for dissemination to the public, but the above; and proposed rule change and discussed any trade does not need to be transmitted to NSCC (7) In transactions conducted through comments it received on the proposed because one of the parties to the trade is a customer (i.e., not a broker-dealer), or the buyer and seller an ACT/NNMS ECN in which neither of rule change. The text of these statements both are broker-dealers and they have a common the parties is a member, the ACT/NNMS may be examined at the places specified clearing arrangement that will enable them to settle ECN shall report the transaction in in Item IV below. Nasdaq has prepared the trade without using NSCC’s facilities.

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in clearing-only reports; 7 (3) tape members will be able to report, among fully anonymously, using SIZE in reports of locked-in trades that are to be other things, the security identity, the SuperMontage’s Non-Directed Order submitted to clearing; 8 and (4) non- number of shares, the price, whether the processing. 9 clearing, non-tape reports. A member member is the buyer or seller, and The processing of fully anonymous that seeks to submit a locked-in report whether its member is acting as agent or trades is the same regardless of whether to SuperMontage must have agreements principal. In addition, to facilitate the the trade is executed as a result of a with its contra party that permit one or reporting of pre-open, after-hours, and match occurring in the Non-Directed both of them to submit orders to late reports in the first phase, members Order processing or matched in a SuperMontage on behalf of the other, will be required to include the time of and to report trades on behalf of both of execution on all reports submitted to member’s own system and submitted to the parties.10 SuperMontage.12 SuperMontage for reporting purposes. Members will be able to report trades The proposal is designed to provide For example, the identities of all the through SuperMontage during the hours members several benefits, including the parties (buyer, seller, and reporting that ACT is operational, which possibility of consolidating the systems member) will be known to Nasdaq and presently is 8:00 a.m. until 6:30 p.m. used for reporting and executing trades. NSCC at all times.14 In addition, the eastern time. The full reporting In addition, members will be able to anonymous trades reported through functionality will be implemented in take advantage of the anonymity feature SuperMontage will be included in the phases and, when fully implemented, available in SuperMontage, which is not risk management reports Nasdaq issues with the exception of those trades for available for trades submitted directly to each day, and Nasdaq will reveal contra which comparison through ACT is ACT, and combine it with the benefits party identities to members on a trade- necessary, members will be able to of ‘‘give-up’’ relationships, which by-trade basis if NSCC ceases to act for report to SuperMontage the same types members utilize today in SuperMontage the buyer or seller, or one of their of trades they can report directly and ACT.13 The result is that a member clearing firms.15 through ACT today.11 In the first phase, will be able to give up the true contra parties to a trade, but still preserve full 2. Statutory Basis 7 A transaction is ‘‘locked-in’’ when the buying anonymity between these parties. Nasdaq believes that the proposed and selling broker-dealers have agreed to all the For example, today ECNs match trade details prior to submitting the trade to Nasdaq rule change is consistent with the buyers and sellers in their own systems and no further comparison is necessary. A ‘‘locked- provisions of Section 15A of the Act,16 in clearing-only report’’ is a report that is locked- and provide anonymity by becoming the in general and with Section 15A(b)(6) of in and Nasdaq must forward the trade to NSCC for contra party to each party. With the settlement. The trade does not have to be the Act,17 in particular, in that it is proposed feature, the ECN could submit disseminated to the public because an exception to designed to foster coordination and the public reporting requirement is applicable (e.g., the same matched order to the transaction is the offsetting leg of a riskless SuperMontage for anonymous cooperation with persons engaged in principal trade). processing and give up the parties that regulating, clearing, settling, processing 8 A ‘‘tape report of a locked-in trade that is matched in its system. Now, instead of information with respect to, and submitted for clearing’’ is a locked-in report of a facilitating transactions in securities. trade that must be disseminated to the public and the ECN being the contra party, the settled through NSCC. parties that matched through the ECN Nasdaq asserts that the proposal is 9 A ‘‘non-clearing, non-tape report’’ is a report of will be direct contra parties. Full consistent with this obligation because trade that is not required to be disseminated to the anonymity (i.e., anonymity through it will provide members both the public and does not need to be transmitted to NSCC opportunity to consolidate the for settlement, but the broker-dealer is obligated or settlement) will be preserved because chooses to submit this ‘‘regulatory report’’ to the actual buyer and seller will be execution and reporting of trades and to Nasdaq. See, e.g., NASD Rule 4632 (d)(3)(B) and informed that SIZE is their contra party, combine the benefits give-up NASD Notice to Members 00–79. just the same as today when they trade relationships and anonymous trading. 10 Today a member can submit locked-in trades to ACT if it has executed an Automated Confirmation B. Self-Regulatory Organization’s Transaction Services Service Bureau/Executing necessary system changes. See infra note 12 for a Broker Supplement to the Nasdaq Workstation II discussion concerning reporting .T and .SLD trades Statement on Burden on Competition Agreement (‘‘Attachment 2 Agreement’’) with its to SuperMontage. contra party and the agreement has been filed with 12 Today, ACT automatically appends the .SLD Nasdaq does not believe that the Nasdaq. In addition, a member can submit orders modifier or .T modifier, as appropriate, to reports proposed rule change would result in to SuperMontage on behalf of another member if it receives that contain the time of execution. ACT any burden on competition that is not Nasdaq has on file a Nasdaq National Market compares the time of execution to the time the Execution System Give-Up Addendum to the report was received by ACT, and if more than 90 necessary or appropriate in furtherance Nasdaq Workstation II Subscriber Agreement seconds has elapsed between these times and the of the purposes of the Act. (commonly referred to as the ‘‘SuperMontage Give- report does not contain the .SLD modifier, ACT will Up Agreement’’) that has been executed by both append the .SLD modifier. Similarly, ACT will read C. Self-Regulatory Organization’s parties. Among other things, these agreements the time of execution, and if this time is outside Statement on Comments on the establish which member is responsible for settling normal market hours and the .T modifier is not Proposed Rule Change Received From trades. A member that wishes to report locked-in included on the report, ACT will append the .T trades through SuperMontage must have on file modifier. Therefore, requiring members to include Members, Participants, or Others with Nasdaq executed Attachment 2 and the time of execution on reports submitted to SuperMontage Give-Up agreements for each SuperMontage will enable them to submit late Written comments were neither member for which it will report trades though reports and reports of pre-open and after-hours solicited nor received. SuperMontage. trades, because ACT will validate the time of 11 Initially, with the exception of .T and .SLD execution and automatically append the .SLD 14 trades, SuperMontage will not accept reports of modifier or the .T modifier, as appropriate. A detailed description of the processing of trades that must include trade report modifiers (e.g., 13 When a ‘‘give-up’’ occurs, the member that anonymous orders in SuperMontage is contained in the .W modifier). During this initial phase submits the order to SuperMontage (or the trade the Commission’s order approving the anonymity SuperMontage also will not accept reports of trades report to ACT) discloses to the contra party that the feature. See Securities Exchange Act Release No. that include special settlement conditions (e.g., order (or report) is being entered on behalf of 48527 (September 23, 2003), 68 FR 56361 next-day settlement), special processing conditions another member and the trade is to be settled with (September 30, 2003). (e.g., reversals), or ‘‘as/of’’ reports, which are this other member. The member submitting the 15 NSCC’s authority to cease to act for one of its reports of a transaction executed on a previous day. order (or trade report) has ‘‘given up’’ the identity participants is contained in NSCC Rule 46. Members will be able to submit these types of of the other member who is the true party to the 16 15 U.S.C. 78o–3. reports to SuperMontage once Nasdaq makes that trade. 17 15 U.S.C. 78o–3(b)(6).

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III. Date of Effectiveness of the • Send an e-mail to rule- SECURITIES AND EXCHANGE Proposed Rule Change and Timing for [email protected]. Please include File COMMISSION Commission Action Number SR–NASD–2004–034 on the The foregoing rule change has become subject line. [Release No. 34–49738; File No. SR–NASD– effective pursuant to Section 19(b)(3)(A) Paper comments: 2004–072] of the Act 18 and subparagraph (f)(5) of • Send paper comments in triplicate Rule 19b–419 thereunder because it Self-Regulatory Organizations; Notice to Jonathan G. Katz, Secretary, of Filing and Immediate Effectiveness effects a change in an existing order Securities and Exchange Commission, entry or trading system that (i) does not of Proposed Rule Change and 450 Fifth Street, NW., Washington, DC Amendment No. 1 Thereto by the significantly affect the protection of 20549–0609. investors or the public interest; (ii) does National Association of Securities not impose any significant burden on All submissions should refer to File Dealers, Inc. To Establish Fees for the competition; and (iii) does not have the Number SR–NASD–2004–034. This file Use of the Nasdaq Workstation II effect of limiting access to or availability number should be included on the Service by NASD Members via Digital of the system. At any time within 60 subject line if e-mail is used. To help the Subscriber Lines days of the filing of such proposed rule Commission process and review your May 19, 2004. change, the Commission may summarily comments more efficiently, please use abrogate such rule change if it appears only one method. The Commission will Pursuant to Section 19(b)(1) of the to the Commission that such action is post all comments on the Commission’s Securities Exchange Act of 1934 1 2 necessary or appropriate in the public Internet Web site (http://www.sec.gov/ (‘‘Act’’), and Rule 19b–4 thereunder, interest, for the protection of investors, rules/sro.shtml). Copies of the notice is hereby given that on April 26, or otherwise in furtherance of the submission, all subsequent 2004, the National Association of Securities Dealers, Inc. (‘‘NASD’’), purposes of the Act.20 amendments, all written statements through its subsidiary, The Nasdaq Nasdaq believes that the proposed with respect to the proposed rule rule change, as amended, is consistent Stock Market, Inc. (‘‘Nasdaq’’), filed change that are filed with the with the Securities and Exchange with these requirements because it Commission, and all written proposes to add a reporting feature to Commission (‘‘SEC’’ or ‘‘Commission’’) communications relating to the the proposed rule change as described SuperMontage, an existing order-entry proposed rule change between the system that will not have any affect on in Items I, II, and III below, which Items Commission and any person, other than have been prepared by Nasdaq. The the protection of investors. Members are those that may be withheld from the being provided an alternative means to proposed rule change has been filed by public in accordance with the Nasdaq as establishing or changing a report the types of trading they already provisions of 5 U.S.C. 552, will be conduct today, and the anonymity due, fee or other charge under Section available for inspection and copying in 3 feature is the same as currently exists in 19(b)(3)(A)(ii) of the Act and Rule 19b– the Commission’s Public Reference 4 SuperMontage. In addition, the 4(f)(2) thereunder, which renders the Room. Copies of such filing also will be functionality added by the proposed proposal effective upon filing. On May available for inspection and copying at 4, 2004, Nasdaq filed Amendment No. 1 rule change is optional, and thus does 5 not limit access to SuperMontage. the principal office of Nasdaq. All to the proposed rule change. The Nasdaq states that it will make the comments received will be posted Commission is publishing this notice to proposed rule change operative as the without change; the Commission does solicit comments on the proposed rule necessary system changes are not edit personal identifying change, as amended, from interested completed. Nasdaq expects to information from submissions. You persons. implement the first phase of the should submit only information that I. Self-Regulatory Organization’s proposal on or about July 15, 2004. you wish to make available publicly. All Statement of the Terms of Substance of Nasdaq has represented that it will issue submissions should refer to File the Proposed Rule Change a Head Trader Alert informing members Number SR–NASD–2004–034 and of the implementation schedule once should be submitted on or before June Nasdaq proposes to establish fees for the exact dates are determined. 16, 2004. NASD members using the Nasdaq Workstation II (‘‘NWII’’) service via IV. Solicitation of Comments For the Commission, by the Division of Digital Subscriber Line (‘‘DSL’’) Market Regulation, pursuant to delegated connections. Nasdaq will implement the Interested persons are invited to authority.21 submit written data, views, and proposed rule change on June 1, 2004, Margaret H. McFarland, arguments concerning the foregoing, when it will begin the process of including whether the proposed rule Deputy Secretary. connecting firms through DSL. Below is change, as amended, is consistent with [FR Doc. 04–11843 Filed 5–25–04; 8:45 am] the text of the proposed rule change. the Act. Comments may be submitted by BILLING CODE 8010–01–P Proposed new language is in italics. any of the following methods: * * * * * Electronic comments: • Use the Commission’s Internet 1 15 U.S.C. 78s(b)(1). comment form (http://www.sec.gov/ 2 17 CFR 240.19b–4. rules/sro.shtml); or 3 15 U.S.C. 78s(b)(3)(A)(ii). 4 17 CFR 240.19b–4(f)(2). 5 See letter from John M. Yetter, Associate 18 15 U.S.C. 78s(b)(3)(A). General Counsel, Nasdaq, to Katherine A. England, 19 17 CFR 240.19b–4(f)(5). Assistant Director, Division of Market Regulation, 20 For purposes of calculating the 60-day SEC, dated May 3, 2004 (‘‘Amendment No. 1’’). abrogation period, the Commission considers the Amendment No. 1 changes the implementation period to commence on April 27, 2004, the date dates of the proposal (see discussion, infra, at I, Nasdaq filed Amendment No. 1. 21 17 CFR 200.30–3(a)(12). II(A)).

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7000. Charges for Services and (f) Nasdaq WorkstationTM Service. communications linkages prescribed for Equipment (1)(A) The following charges shall the Nasdaq Workstation II Service: 7010. System Services apply to the receipt of Level 2 or Level (a)–(e) No change. 3 Nasdaq Service via equipment and

Service Charge ...... $2,035/month per service delivery platform (‘‘SDP’’) connected via T1 circuits. $1,000/month per SDP connected via Digital Subscriber Line (‘‘DSL’’), plus $1,000 per DSL early termination fee if service is terminated within 60 days of installation. Display Charge ...... $525/month per logon for the first 150 logons. $200/month for each additional logon. Additional Circuit/SDP Charge ...... $3,235/month. PD and SDP Maintenance: Monthly maintenance agreement ...... $55/presentation device (‘‘PD’’) logon or SDP/month. Hourly fee for maintenance provided without monthly maintenance $195 per hour (two hour minimum), plus cost of parts. agreement.

(B) A subscriber that accesses Nasdaq on or before June 1, 2004 shall not be Nasdaq represents that, in the past, Workstation II Service via an required to pay charges under Rule 7040 the only option available for connecting application programming interface for initial disconnection of T1 circuits a subscriber’s SDP to Nasdaq has been (‘‘API’’) shall be assessed the Service and installation of DSL. In addition, if the use of a dedicated T1 circuit pair, Charge for each of the subscriber’s SDPs such a subscriber cancels DSL service provided by Nasdaq’s and shall be assessed the Display Charge within 10 business days of its first date telecommunications service provider for each of the subscriber’s logons, of DSL service, the subscriber shall not pursuant to a contract with Nasdaq. including logons of an NWII substitute be required to pay the early termination Nasdaq has concluded that this ‘‘one- or quote-update facility. API subscribers fee or charges under Rule 7040 for size-fits-all’’ approach is unduly also shall be subject to the Additional disconnection of DSL and reinstallation expensive for small firms that never use Circuit /SDP Charge. of T1 circuits. most of the bandwidth 6 associated with (C) A subscriber shall be subject to the (2) No change. T1 circuits. Accordingly, Nasdaq plans Additional Circuit/SDP Charge when (g)–(u) No change. to offer subscribers the option of the subscriber has not maximized * * * * * connecting through lower-bandwidth, capacity on its SDP(s) by placing eight II. Self-Regulatory Organization’s lower-cost DSL service. Other market logons on an SDP and obtains an Statement of the Purpose of, and centers, including the New York Stock additional SDP(s); in such case, the Statutory Basis for, the Proposed Rule Exchange and the Archipelago Exchange subscriber shall be charged the Change facility of the Pacific Exchange, allow Additional Circuit/SDP Charge (in lieu firms to connect to their trading systems of the service charge) for each In its filing with the Commission, through DSL.7 ‘‘underutilized’’ SDP(s) (i.e., the Nasdaq included statements concerning Nasdaq states that it will use a difference between the number of SDPs the purpose of and basis for the certificate-based ‘‘Virtual Private a subscriber has and the number of proposed rule change and discussed any Network’’ (‘‘VPN’’) architecture to SDPs the subscriber would need to comments it received on the proposed provide the highest level of security support its logons, assuming an eight-to- rule change. The text of these statements currently available for internet traffic. one ratio). A subscriber also shall be may be examined at the places specified Data transmitted through the VPN will subject to the Additional Circuit/SDP in Item IV below. Nasdaq has prepared be encrypted using Triple Data Charge when the subscriber has not summaries, set forth in Sections A, B, Encryption Internet Protocol Security maximized capacity on its T1 circuits by and C below, of the most significant (‘‘3DES IPSec’’) encryption, which is placing eighteen SDPs on a T1 circuit; aspects of such statements. more robust than the encryption used by in such case, the subscriber shall be A. Self-Regulatory Organization’s on-line banking and brokerage services. charged the Additional Circuit/SDP Statement of the Purpose of, and Nasdaq represents that it will also Charge (in lieu of the service charge) for Statutory Basis for, the Proposed Rule take steps designed to ensure that DSL each ‘‘underutilized’’ SDP slot on the Change connections generally support the same existing T1 circuit(s). Regardless of the level of performance as small firm NWII SDP allocation across T1 circuits, a 1. Purpose subscriber will not be subject to the Nasdaq states that the NWII service 6 The term ‘‘bandwidth’’ refers to the amount of Additional Circuit/SDP Charge if the allows market participants to access The data that can be transmitted in one second. subscriber does not exceed the Nasdaq Stock Market and other Nasdaq Specifically, 1.2 megabits per second of data can be transmitted over each of the T1 circuits used to minimum number of T1 circuits needed facilities, using either an ‘‘NWII support an SDP. A subscriber that regularly to support its SDP, assuming an presentation device’’ (a workstation and transmitted a much smaller quantity of data would eighteen-to-one ratio. associated software provided by not be utilizing the bandwidth inherent in its T1 (D) DSL service (i) shall be provided Nasdaq) or the subscriber’s own circuits. Conversely, a subscriber that utilized most of its bandwidth would eventually be required to solely to NASD members without API workstation and software (often referred obtain an additional SDP to ensure that sufficient logons, (ii) shall be provided to only one to as an ‘‘application programming bandwidth was always available to it. SDP per location, and (iii) may not be interface’’ or ‘‘API’’ device). Each 7 See www.nyse.com/pdfs/anondotintroguide.pdf used in connection with SDP T1 circuit subscriber location has at least one (describing internet access to NYSE’s Anonymous SuperDOT system); www.tradearca.com/exchange/ connections at the same location. A service delivery platform (‘‘SDP’’) to realtick.asp (describing DSL access to Archipelago subscriber with an SDP connected to which it connects the workstations used via RealTick product of Townsend Analytics, Nasdaq via T1 circuits that orders DSL by its employees. Ltd.).

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customers currently receive through 2. Statutory Basis • Use the Commission’s Internet their T1 circuits. Specifically, because comment form (http://www.sec.gov/ Nasdaq believes that the proposed API devices are frequently used to rules/sro.shtml); or support high volume computer- rule change is consistent with the provisions of section 15A of the Act,9 in • Send an e-mail to rule- generated transactions whereas NWII [email protected]. Please include File presentation devices must be operated general, and section 15A(b)(5) of the 10 Number SR–NASD–2004–072 on the by an individual and therefore transmit Act, in particular, in that it provides subject line. lower volumes of data, DSL connections for the equitable allocation of reasonable will only be available to subscribers dues, fees and other charges among Paper comments: members. Nasdaq believes the proposed without API logons. In addition, Nasdaq • Send paper comments in triplicate will provide only one DSL connection rule change will allow Nasdaq to charge small firms that use the NWII service to Jonathan G. Katz, Secretary, per site and will not allow simultaneous Securities and Exchange Commission, use of DSL and T1 connections at the fees that are more commensurate with the lower levels of bandwidth that they 450 Fifth Street, NW., Washington, DC same site, because a firm with sufficient 20549–0609. bandwidth needs to require more than use. All submissions should refer to File one connection at a particular site B. Self-Regulatory Organization’s would be better served by having one or Statement on Burden on Competition Number SR–NASD–2004–072. This file more T1 connections. Finally, firms number should be included on the whose needs for simultaneous access to Nasdaq does not believe that the subject line if e-mail is used. To help the data about a significant number of proposed rule change will result in any Commission process and review your securities is such that they would be in burden on competition that is not comments more efficiently, please use danger of exhausting the bandwidth necessary or appropriate in furtherance only one method. The Commission will available through a DSL connection will of the purposes of the Act. post all comments on the Commission’s be advised to use a T1 connection. C. Self-Regulatory Organization’s Internet Web site (http://www.sec.gov/ Nasdaq states that, prior to submitting Statement on Comments on the rules/sro.shtml). Copies of the this rule filing, it contacted 10 of the Proposed Rule Change Received From submission, all subsequent approximately 150 firms that Nasdaq Members, Participants, or Others amendments, all written statements believes may be interested in using DSL. with respect to the proposed rule Nasdaq represents that all of the firms Written comments were neither change that are filed with the that were contacted stated that they solicited nor received. Commission, and all written would be interested in trying DSL, and III. Date of Effectiveness of the communications relating to the most expressed an interest in doing so Proposed Rule Change and Timing for proposed rule change between the as soon as possible. Accordingly, Commission Action Commission and any person, other than Nasdaq will begin taking orders for the those that may be withheld from the new service during May 2004, and will The foregoing rule change has become public in accordance with the effective pursuant to section begin the process of connecting firms provisions of 5 U.S.C. 552, will be 19(b)(3)(A)(ii) of the Act 11 and that order the service in June 2004. available for inspection and copying in subparagraph (f)(2) of Rule 19b–4 Nasdaq states that the monthly charge the Commission’s Public Reference thereunder,12 because it establishes or for an SDP attached to a DSL line will changes a due, fee, or other charge Room. Copies of such filing also will be be $1,000 per month, less than half the imposed by Nasdaq. At any time within available for inspection and copying at charge of $2,035 per month for a T1 60 days of the filing of the proposed rule the principal office of Nasdaq. All connection, reflecting the lower cost of change, the Commission may summarily comments received will be posted the lower bandwidth service. Firms abrogate such rule change if it appears without change; the Commission does wishing to switch from T1 to DSL to the Commission that such action is not edit personal identifying would be required to pay the cost of necessary or appropriate in the public information from submissions. You disconnecting one line and connecting interest, for the protection of investors, should submit only information that the other.8 A subscriber that cancels its or otherwise in furtherance of the you wish to make available publicly. All service within 60 days of installation purposes of the Act.13 submissions should refer to File would be charged an early termination Number SR–NASD–2004–072 and fee of $1,000 per terminated DSL. IV. Solicitation of Comments should be submitted on or before June Nasdaq represents that, in order to 16, 2004. encourage firms that may benefit from Interested persons are invited to DSL usage to switch rapidly, however, submit written data, views, and For the Commission, by the Division of it will waive the disconnection and arguments concerning the foregoing, Market Regulation, pursuant to delegated connection charges for firms that order including whether the proposed rule authority.14 change is consistent with the Act. the new service by June 1, 2004. Margaret H. McFarland, Moreover, firms ordering DSL by that Comments may be submitted by any of the following methods: Deputy Secretary. date will be permitted to use it on a 10- [FR Doc. 04–11884 Filed 5–25–04; 8:45 am] day trial basis, and may return to T1 Electronic comments: connections at the end of the 10-day BILLING CODE 8010–01–P period at no additional cost (i.e., Nasdaq 9 15 U.S.C. 78o–3. will waive the associated disconnection, 10 15 U.S.C. 78o–3(b)(5). reconnection, and early termination 11 15 U.S.C. 78s(b)(3)(A)(ii). 12 fees). 17 CFR 240.19b–4(f)(2). 13 For purposes of calculating the sixty-day abrogation period, the Commission considers the 8 See NASD Rule 7040 (authorizing charges for period to have begun on May 4, 2004, the date installation, removal, or relocation of NWII-related Nasdaq submitted Amendment No. 1. See 15 U.S.C. equipment). 78s(b)(3)(C). 14 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE transactions, and in proportion to requirements of the Act and the rules COMMISSION round-lot volume, as follows: and regulations thereunder applicable to a. Market Orders. Odd-lot market a national securities exchange.6 In [Release No. 34–49745; File No. SR–NYSE– orders would be executed in time 2003–37] particular, the Commission finds that priority at the price of the next round- the proposed rule change, as amended, Self-Regulatory Organizations; Order lot transaction. Buy and sell orders is consistent with Section 6(b)(5) of the Approving Proposed Rule Change and would, in essence, be netted against one Act,7 in that it is designed to promote Amendment No. 1 Thereto by the New another and executed (the specialist is just and equitable principles of trade, to technically the contra party to the buy York Stock Exchange, Inc. To Amend remove impediments to and perfect the orders and to the sell orders, but since Exchange Rule 124 To Change the Way mechanism of a free and open market the specialist is buying the same amount Odd-Lot Orders Are Priced and and a national market system, and, in Executed Systemically that he or she is selling, there is no economic consequence to the specialist general, to protect investors and the May 20, 2004. in this type of pairing-off of orders). Any public interest. I. Introduction imbalance of buy or sell orders would In the Notice, the NYSE noted that be executed against the specialist, but certain legitimate trading strategies may On November 18, 2003, the New York only up to the size of the round-lot result in specialists having to assume Stock Exchange, Inc. (‘‘NYSE’’ or transaction. Any market orders that do large positions of aggregated odd-lot ‘‘Exchange’’) filed with the Securities not receive an execution because of the orders at prices that are not necessarily and Exchange Commission (‘‘SEC’’ or volume limitation would be executed, reflective of the prices such orders ‘‘Commission’’) a proposed rule change in time priority order, at the price of the would have received had they been pursuant to Section 19(b)(1) of the next round-lot transaction, subject to the Securities Exchange Act of 1934 executed pursuant to the supply and volume limitation. There would be a demand dynamics of the round-lot (‘‘Act’’),1 and Rule 19b–4 thereunder,2 ‘‘timer’’ provision in the rule to provide auction market.8 The Commission to amend Exchange Rule 124 to change that an order not executed within 30 believes that the proposal is a the way odd-lot orders are priced and seconds would be executed at the price executed systemically. On March 31, of the adjusted ITS best round-lot bid reasonable response to this unintended 2004, the Exchange amended the (in the case of a sell order) or offer (in use and consequence of NYSE’s current proposed rule change.3 The proposed the case of a buy order). odd-lot process. Under the proposed rule change, as amended by b. Limit Orders. Odd-lot limit orders rule change, as amended, the NYSE Amendment No. 1, was published for would be executed at the price of the should continue to accommodate comment in the Federal Register on first round-lot transaction that is at or traditional odd-lot orders in a manner April 14, 2004.4 The Commission better than the limit price of the order, that is based on the prevailing market, received no comments on the proposed subject to the volume limitation of the while limiting a specialist’s financial rule change, as amended. This order round-lot transaction. Odd-lot limit exposure. The Commission believes that approves the proposed rule change, as orders also would be aggregated with the proposed rule change, as amended, amended. odd-lot market orders for purposes of represents a reasonable method of II. Description the volume limitation. Limit orders pricing odd-lot orders because the eligible for execution would be pricing of odd-lot orders at the The Exchange is proposing to change intermingled with market orders for the way odd-lot orders are priced and execution would reflect actual round-lot purposes of determining time priority, executed systemically. Currently, odd- market price and activity at the time of and buy and sell orders would be netted lot orders do not enter the Exchange’s execution. against each other in the same fashion auction market, but are executed as market orders. As with odd-lot IV. Conclusion systemically, with the specialist being market orders, odd-lot limit orders assigned as the contra-party in all cases. which would otherwise receive a partial It is therefore ordered, pursuant to Currently, odd-lot market orders to buy 9 execution would be executed in full. Section 19(b)(2) of the Act, that the (sell) are generally executed at the price There would be no ‘‘timer’’ for odd-lot proposed rule change (SR–NYSE–2003– of the adjusted ITS round-lot offer limit orders. 37) and Amendment No. 1 are (bid) 5 at the time the Exchange’s system c. Short Sale Orders. A short sale approved. receives the order, and odd-lot limit market odd-lot order would be eligible orders are generally executed at the For the Commission, by the Division of for execution at the price of the next price of the first round-lot transaction, Market Regulation, pursuant to delegated sale in the round-lot market on the 10 subsequent to the receipt of the order by authority. Exchange which is higher than the last the system, that is at or better than the Margaret H. McFarland, different round-lot transaction. Short limit price on the order. Deputy Secretary. sale limit odd-lot orders would be Under the proposal, odd-lot orders [FR Doc. 04–11881 Filed 5–25–04; 8:45 am] would be priced and executed at the eligible for execution at the price of the BILLING CODE 8010–01–P price of subsequent round-lot first round-lot transaction on the Exchange which is at or above the 1 15 U.S.C. 78s(b)(1). specified limit of the order, and which 2 17 CFR 240.19b–4. is also higher than the last different 3 See letter, from Darla C. Stuckey, Corporate round-lot transaction. 6 In approving this proposal, the Commission has Secretary, NYSE, to Nancy J. Sanow, Assistant d. Stop Orders. Stop orders in odd- considered the proposed rule’s impact on Director, Division of Market Regulation, lots would be handled as they are today. efficiency, competition, and capital formation. 15 Commission, dated March 30, 2004 and U.S.C. 78c(f). accompanying Form 19b–4 (‘‘Amendment No. 1’’). III. Discussion 7 15 U.S.C. 78f(b)(5). 4 See Securities Exchange Act Release No. 49536 8 (April 7, 2004), 69 FR 19890 (‘‘Notice’’). After careful review, the Commission See note 4, supra. 5 ‘‘Adjusted ITS bid’’ and ‘‘adjusted ITS offer’’ are finds that the proposed rule change, as 9 15 U.S.C. 78s(b)(2). defined in NYSE Rule 124.60. amended, is consistent with the 10 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE crowd who directed that the bid (offer) broker-dealer effects the transaction COMMISSION be disseminated and available for because of its obligation to log onto the execution on Auto-Ex. Auto-Ex wheel and is entitled to hold [Release No. 34–49737; File No. SR–PCX– 2004–36] * * * * * the crowd market maker to his or her quote and offset the Auto-Ex position by II. Self-Regulatory Organization’s Self-Regulatory Organizations; Notice trading with the crowd market maker Statement of the Purpose of, and 6 of Filing and Immediate Effectiveness (who set the price). Statutory Basis for, the Proposed Rule of Proposed Rule Change by the Change 2. Statutory Basis Pacific Exchange, Inc. Relating to Exchange Fees and Charges In its filing with the Commission, the The Exchange believes that the Exchange included statements proposed rule change is consistent with May 19, 2004. concerning the purpose of and basis for Section 6(b) of the Act,7 in general, and Pursuant to Section 19(b)(1) of the the proposed rule change and discussed Section 6(b)(4) of the Act,8 in particular, Securities Exchange Act of 1934 any comments it had received on the in that it provides for the equitable 1 2 (‘‘Act’’) and Rule 19b–4 thereunder, proposed rule change. The text of these allocation of reasonable dues, fees and notice is hereby given that on April 19, statements may be examined at the other charges among its members. 2004, the Pacific Exchange, Inc. (‘‘PCX’’ places specified in Item IV below. The or ‘‘Exchange’’) filed with the Securities Exchange has prepared summaries, set B. Self-Regulatory Organization’s and Exchange Commission forth in Sections A, B, and C below, of Statement on Burden on Competition (‘‘Commission’’) the proposed rule the most significant aspects of such The Exchange does not believe that change as described in Items I, II, and statements. III below, which the Exchange has the proposed rule change will impose prepared. The Exchange has designated A. Self-Regulatory Organization’s any burden on competition that is not this proposal as one establishing or Statement of the Purpose of, and necessary or appropriate in furtherance changing a due, fee, or other charge Statutory Basis for, the Proposed Rule of the purposes of the Act. Change imposed by the Exchange under Section C. Self-Regulatory Organization’s 19(b)(3)(A)(ii) of the Act 3 and Rule 19b– 1. Purpose Statement on Comments on the 4(f)(2) thereunder,4 which renders the The Exchange charges a standard rate Proposed Rule Change Received From proposal effective upon filing with the Members, Participants, or Others Commission. The Commission is of $0.21 per contract side for publishing this notice to solicit transactions executed by broker-dealers The Exchange neither solicited nor comments on the proposed rule change on the Exchange. The Exchange also received written comments with respect from interested persons. offers performance incentives tied to to the proposed rule change. market share and may adjust the I. Self-Regulatory Organization’s transaction fee to a sum between $0.05– III. Date of Effectiveness of the Statement of the Terms of Substance of $0.21 per contract side depending upon Proposed Rule Change and Timing for the Proposed Rule Change the quality of a broker-dealer’s Commission Action performance. The Exchange applies a The Exchange proposes to amend the The foregoing rule change has become Trade-Related Charges portion of its transaction fee to all transactions, regardless of whether they occur effective pursuant to Section Schedule of Fees and Charges in order 19(b)(3)(A)(ii) of the Act 9 and to modify applicability of the broker- automatically or manually. The Exchange proposes to amend its subparagraph (f)(2) of Rule 19b–4 dealer transaction fee. Below is the text thereunder 10 because it establishes or of the proposed rule change, as Schedule of Fees and Charges in order to exclude certain transactions from the changes a due, fee, or other charge amended. Proposed new language is in imposed by the Exchange. At any time italics. applicability of the transaction fee. Specifically, the Exchange proposes not within 60 days after the filing of the * * * * * to apply the fee to a transaction where proposed rule change, the Commission SCHEDULE OF FEES AND CHARGES the broker-dealer: (i) Is obligated to log may summarily abrogate the rule change FOR EXCHANGE SERVICES onto the Auto-Ex wheel and satisfy if it appears to the Commission that Auto-Ex transactions at a price set by such action is necessary or appropriate PCX OPTIONS: TRADE-RELATED in the public interest, for the protection CHARGES another broker-dealer and (ii) immediately offsets 5 that Auto-Ex of investors, or otherwise in furtherance TRANSACTIONS position to the member of the trading of the purposes of the Act. Customer: $0.00 per contract side crowd who directed that the bid (offer) be disseminated and available for 6 The PCX has represented that (i) it will surveil Firm: $0.10 per contract side for for the situation in which the member of the trading customer facilitation execution on Auto-Ex. The Exchange crowd who directed that the bid (offer) be Broker/Dealer: $0.21 per contract side * believes that the proposed exclusion is disseminated and available for execution on Auto- * This fee will not apply to the equitable given that the executing Ex also is the counterparty to the Auto-Ex trade and transactions where a broker dealer: (i) Is (ii) it will inform the Division of the number of such trades that occur in the six months following the 5 The PCX confirmed that, if the broker-dealer obligated to log onto the Auto-Ex wheel effective date of the proposed rule change. See who is obligated to log onto the Auto-Ex wheel and and satisfy Auto-Ex transactions at a telephone conversation among Mai S. Shiver, satisfy the Auto-Ex transaction at a price set by Acting Director/Senior Counsel, PCX; Kim St. price set by another broker dealer, and another broker-dealer does not offset that Auto-Ex Hilaire, Vice President Strategic Marketing, PCX; (ii) immediately offsets that Auto-Ex position immediately, then such broker-dealer will Susie Cho, Special Counsel, Division, Commission; not be entitled to receive the fee exclusion for the position to the member of the trading and David Hsu, Attorney, Division, Commission, on offset transaction. See telephone conversation May 17, 2004. among Mai S. Shiver, Acting Director/Senior 1 7 15 U.S.C. 78s(b)(1). Counsel, PCX; Susie Cho, Special Counsel, Division 15 U.S.C. 78f(b). 2 17 CFR 240.19b–4. of Market Regulation (‘‘Division’’), Commission; 8 15 U.S.C. 78f(b)(4). 3 15 U.S.C. 78s(b)(3)(A)(ii). and David Hsu, Attorney, Division, Commission, on 9 15 U.S.C. 78s(b)(3)(A)(ii). 4 17 CFR 240.19b–4(f)(2). May 17, 2004. 10 17 CFR 240.19b–4(f)(2).

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IV. Solicitation of Comments SECURITIES AND EXCHANGE Decorum Regulations, that is repetitive, Interested persons are invited to COMMISSION egregious or of a publicly embarrassing submit written data, views, and nature to the Exchange. [Release No. 34–49748; File No. SR–Phlx– [(f) Any action by a member of the arguments concerning the foregoing, 2004–34] including whether the proposed rule Board of Governors or any Exchange change is consistent with the Act. Self-Regulatory Organizations; Notice Committee, or by any member organization associated with such Comments may be submitted by any of of Filing and Immediate Effectiveness member, which contravenes the Seat the following methods: of Proposed Rule by the Philadelphia Electronic comments: Stock Exchange, Inc. Relating to the Transaction Policy contained in Article • Use the Commission’s Internet Rescission of Commentary .01(f) to V of the Code of Conduct for Governors comment form (http://www.sec.gov/ Exchange Rule 708 and Committee Members.] rules/sro.shtml); or * * * * * • Send an E-mail to rule- May 20, 2004. Pursuant to Section 19(b)(1) of the II. Self-Regulatory Organization’s [email protected]. Please include File Statement of the Purpose of, and Number SR–PCX–2004–36 on the Securities Exchange Act of 1934 (‘‘Act’’),1 and Rule 19b–4 thereunder,2 Statutory Basis for, the Proposed Rule subject line. Change Paper comments: notice is hereby given that on May 11, • Send paper comments in triplicate 2004, the Philadelphia Stock Exchange, In its filing with the Commission, the to Jonathan G. Katz, Secretary, Inc. (‘‘Phlx’’ or ‘‘Exchange’’) filed with Phlx included statements concerning Securities and Exchange Commission, the Securities and Exchange the purpose of and basis for the 450 Fifth Street, NW., Washington, DC Commission (‘‘Commission’’) the proposed rule change and discussed any 20549–0609. proposed rule change as described in comments it received on the proposed All submissions should refer to File Items I, II, and III below, which Items rule change. The text of these statements Number SR–PCX–2004–36. This file have been prepared by the Phlx. The may be examined at the places specified number should be included on the Commission is publishing this notice to in Item IV below. The Phlx has prepared subject line if e-mail is used. To help the solicit comments on the proposed rule summaries, set forth in Sections A, B, Commission process and review your change from interested persons. and C below, of the most significant comments more efficiently, please use aspects of such statements. I. Self-Regulatory Organization’s only one method. The Commission will Statement of the Terms of Substance of A. Self-Regulatory Organization’s post all comments on the Commission’s the Proposed Rule Change Statement of the Purpose of, and Internet Web site (http://www.sec.gov/ Statutory Basis for, the Proposed Rule The Phlx proposes to rescind rules/sro.shtml). Copies of the Change submission, all subsequent Commentary .01(f) to Exchange Rule amendments, all written statements 708 (Acts Detrimental to the Interest or 1. Purpose with respect to the proposed rule Welfare of the Exchange). The text of the The purpose of the proposed rule change that are filed with the proposed rule change is set forth below. change is to rescind Commentary .01(f) Commission, and all written Proposed new language is in italics, and to Exchange Rule 708 because this communications relating to the proposed deletions are in [brackets]. comment has been made obsolete as a proposed rule change between the * * * * * result of the demutualization of the Commission and any person, other than 3 Rule 708. Acts Detrimental to the Exchange. those that may be withheld from the Currently, Commentary .01(f) to Phlx Interest or Welfare of the Exchange public in accordance with the Rule 708 provides that acts detrimental provisions of 5 U.S.C. 552, will be A member, member organization, or to the interest or welfare of the available for inspection and copying in person associated with or employed by Exchange include, but are not limited the Commission’s Public Reference a member or member organization shall to, any action by a member of the Board Section, 450 Fifth Street, NW., not engage in acts detrimental to the of Governors or any Exchange Washington, DC 20549. Copies of such interest or welfare of the Exchange. Committee, or by any member filing also will be available for Commentary: organization associated with such inspection and copying at the principal .01 Acts which could be deemed member, which contravenes the Seat office of the Exchange. All comments detrimental to the interest or welfare of Transaction Policy contained in Article received will be posted without change; the Exchange include, but are not V of the Code of Conduct for Governors the Commission does not edit personal limited to, the following: and Committee Members. Ownership in identifying information from (a) Conviction or guilty plea to any the Exchange is no longer represented submissions. You should submit only felony charge or any securities or fraud- through seats but rather shares of stock information that you wish to make related criminal misconduct; in the Exchange. Therefore, due to the available publicly. (b) Use or attempted use of elimination of the concept of seat All submissions should refer to File unauthorized assistance while taking ownership, the Seat Transaction Policy Number SR–PCX–2004–36 and should any securities industry or Exchange- in Commentary .01(f) to Rule 708 is be submitted on or before June 16, 2004. related qualification examination; obsolete. (c) Failure to make a good faith effort For the Commission, by the Division of to pay any fees, dues, fines or other 2. Statutory Basis Market Regulation, pursuant to delegated authority.11 monies due and owing to the Exchange; The Exchange believes that its (d) Destruction or misappropriation of Margaret H. McFarland, proposal is consistent with Section 6(b) Exchange or member property; or of the Act 4 in general, and furthers the Deputy Secretary. (e) Misconduct on the trading floor, in [FR Doc. 04–11883 Filed 5–25–04; 8:45 am] violation of the Exchange’s Order and 3 See Securities Exchange Act Release No. 49098 BILLING CODE 8010–01–P (January 16, 2004), 69 FR 3974 (January 27, 2004) 1 15 U.S.C. 78s(b)(1). (SR–Phlx–2003–73). 11 17 CFR 200.30–3(a)(12). 2 17 CFR 240.19b–4. 4 15 U.S.C. 78f(b).

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objectives of Section 6(b)(5) of the Act 5 • Send an e-mail to rule- SUMMARY: The FAA is publishing notice in particular, in that it removes an [email protected]. Please include File of proposed release of 7.7± acres of land obsolete commentary from Phlx Rule Number SR–Phlx–2004–34 on the (Parcels 41A and 42A) at the 708. subject line. Shenandoah Valley Regional Airport, Paper comments: Staunton, Virginia to the Virginia B. Self-Regulatory Organization’s • Send paper comments in triplicate Statement on Burden on Competition Department of Transportation in to Jonathan G. Katz, Secretary, exchange for 5.6± acres of land (Parcel The Phlx does not believe that the Securities and Exchange Commission, 38). All associated pavement and right- proposed rule change will result in any 450 Fifth Street, NW., Washington, DC of-way maintenance for the new burden on competition that is not 20549–0609. relocated access road will become the necessary or appropriate in furtherance All submissions should refer to File responsibility of the Virginia of the purposes of the Act, as amended. Number SR–Phlx–2004–34. This file number should be included on the Department of Transportation. There are C. Self-Regulatory Organization’s subject line if e-mail is used. To help the no adverse impacts to the Airport and Statement on Comments on the Commission process and review your the land is not needed for airport Proposed Rule Change Received From comments more efficiently, please use development. The relocated access road Members, Participants, or Others only one method. The Commission will Route 771 is shown on the Airport Written comments were neither post all comments on the Commission’s Layout Plan. solicited nor received. Internet Web site (http://www.sec.gov/ DATES: Comments must be received on rules/sro.shtml). Copies of the III. Date of Effectiveness of the or before June 25, 2004. submission, all subsequent Proposed Rule Change and Timing for amendments, all written statements ADDRESSES: Comments on this Commission Action with respect to the proposed rule application may be mailed or delivered The foregoing proposed rule change change that are filed with the in triplicate to the FAA at the following has become effective pursuant to Commission, and all written address: Terry J. Page, Manager, FAA Section 19(b)(3)(A) of the Exchange communications relating to the Washington Airports District Office, Act 6 and Rule 19b–4(f)(6) thereunder 7 proposed rule change between the 23723 Air Freight Lane, Suite 210, because the proposed rule change: (1) Commission and any person, other than Dulles, VA 20166. Does not significantly affect the those that may be withheld from the In addition, one copy of any protection of investors or the public public in accordance with the comments submitted to the FAA must interest; (2) does not impose any provisions of 5 U.S.C. 552, will be be mailed or delivered to Greg W. significant burden on competition; and available for inspection and copying in (3) does not become operative for 30 the Commission’s Public Reference Campbell, Executive Director, days from the date of filing, or such Room. Copies of such filing also will be Shenandoah Valley Regional Airport, at shorter time that the Commission may available for inspection and copying at the following address: Greg W. designate if consistent with the the principal office of the Phlx. All Campbell, Executive Director, protection of investors and the public comments received will be posted Shenandoah Valley Regional Airport interest.8 At any time within 60 days of without change; the Commission does Commission, P.O. Box 125, Weyers the filing of the proposed rule change, not edit personal identifying Cave, VA 24486. the Commission may summarily information from submissions. You FOR FURTHER INFORMATION CONTACT: Mr. abrogate such rule change if it appears should submit only information that Terry Page, Manager, Washington to the Commission that such action is you wish to make available publicly. All Airports District Office, 23723 Air necessary or appropriate in the public submissions should refer to File Freight Lane, Suite 210, Dulles, VA interest, for the protection of investors, Number SR–Phlx–2004–34 and should 20166; telephone (703) 661–1354, fax or otherwise in the furtherance of the be submitted on or before June 16, 2004. purposes of the Act.9 (703) 661–1370, e-mail For the Commission, by the Division of [email protected]. IV. Solicitation of Comments Market Regulation, pursuant to delegated authority.10 SUPPLEMENTARY INFORMATION: On April Interested persons are invited to Margaret H. McFarland, submit written data, views, and 5, 2000, new authorizing legislation arguments concerning the foregoing, Deputy Secretary. became effective. That bill, the Wendell including whether the proposed rule [FR Doc. 04–11882 Filed 5–25–04; 8:45 am] H. Ford Aviation Investment and change is consistent with the Act. BILLING CODE 8010–01–P Reform Act for the 21st Century, Public Comments may be submitted by any of Law 10–181 (Apr. 5, 2000; 114 Stat. 61) the following methods: (AIR 21) requires that a 30 day public Electronic comments: DEPARTMENT OF TRANSPORTATION notice must be provided before the • Use the Commission’s Internet Secretary may waive any condition comment form (http://www.sec.gov/ Federal Aviation Administration imposed on an interest in surplus property. rules/sro.shtml); or Notice Before Waiver With Respect to Land at Shenandoah Valley Regional Issued in Chantilly, Virginia, on May 19, 5 15 U.S.C. 78f(b)(5). Airport, Staunton, VA 2004. 6 15 U.S.C. 78s(b)(3)(A). Terry J. Page, 7 17 CFR 240.19b–4(f)(6). AGENCY: Federal Aviation 8 As required under Rule 19b–4(f)(6)(iii), the Phlx Administration (FAA), DOT. Manager, Washington Airports District Office, provided the Commission with written notice of its Eastern Region. ACTION: Notice of intent of waiver with intent to file the proposed rule change, along with [FR Doc. 04–11897 Filed 5–25–04; 8:45 am] a brief description and text of the proposed rule respect to land. change, at least five business days prior to the filing BILLING CODE 4910–13–M date. 9 15 U.S.C. 78s(b)(3)(C). 10 17 CFR 200.30–3(a)(12).

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DEPARTMENT OF TRANSPORTATION Secretary may waive any condition improve safety, improve access to imposed on an interest in surplus Atchison, Kansas, promote local and Federal Aviation Administration property. regional economic stability, and to address the deficiencies of the Amelia Notice Before Waiver with Respect to Issued in Chantilly, Virginia on May 19, 2004. Earhart Memorial Bridge over the Land at Shenandoah Valley Regional Missouri River. Alternatives under Airport, Staunton, VA Terry J. Page, Manager, Washington District Office, Eastern consideration include taking no action AGENCY: Federal Aviation Region. and possible roadway alignments that Administration (FAA), DOT. [FR Doc. 04–11898 Filed 5–25–04; 8:45 am] will improve the existing 2-lane highway facility to 4-lanes. Also, the ACTION: BILLING CODE 4910–13–M Notice of intent of waiver with Amelia Earhart Memorial Bridge respect to land. alternatives being studied include both SUMMARY: The FAA is publishing notice DEPARTMENT OF TRANSPORTATION the removal and rehabilitation of the of proposed release of 7.6± acres of land bridge. (Parcels 24 and 25) at the Shenandoah Federal Highway Administration A scoping process has been initiated Valley Regional Airport, Staunton, that involves all appropriate federal, Environmental Impact Statement, Virginia to the Virginia Department of state, and local agencies, consulting Atchison County, Kansas and Transportation in exchange for 4.48± parties, private organizations and Buchanan County, Missouri acres of land (Parcel 30). This release is citizens who have previously expressed or are known to have interest in this to provide the Virginia Department of AGENCY: Federal Highway Transportation right-of-way along Administration (FHWA), DOT. proposal. There had been extensive public involvement conducted to date Routes 847 and 900. These roads were ACTION: Notice of intent. constructed under ADAP 6–51–0049–08 on the project including a public to extend runway 23. All associated SUMMARY: The FHWA is issuing this meeting that has resulted in pavement and right-of-way maintenance notice of intent to advise the public that identification of major issues. A public for the existing roads will be the an environmental impact statement will hearing will be held to present the responsibility of the Virginia be prepared for a proposed highway findings of the draft EIS. Public notice Department of Transportation. There are project on U.S. Highway 59 from the will be given of the time and place of no adverse impacts to the Airport and four-lane section within the City of the hearing. The draft EIS will be the land is not needed for airport Atchison in Atchison County, Kansas available for public and agency review development. The road sin their current over the Missouri River to the and comment prior to the public position are shown on the Airport Intersection with State Route 45 in hearing. Layout Plan. Buchanan County, Missouri. To ensure that the full range of issues FOR FURTHER INFORMATION CONTACT: Kurt related to this proposed action are DATES: Comments must be received on addressed and all major issues are or before June 25, 2004. C. Dunn, P.E., Vital Few Team Leader, Federal Highway Administration, 3300 identified in the process, comments and ADDRESSES: Comments on this suggestions are invited from all application may be mailed or delivered Southwest Topeka Boulevard, Suite 1, Topeka, Kansas 66611, Telephone: (785) interested and/or potentially affected in triplicate to the FAA at the following parties. Comments or questions address: Terry J. Page, Manager, FAA 267–7281; Warren L. Sick, Assistant Secretary and State Transportation concerning this proposed action and the Washington Airports District Office, EIS should be directed to the FHWA or 23723 Air Freight Lane, Suite 210, Engineer, Kansas Department of Transportation, 915 Harrison Street, the KDOT at the addresses provided Dulles, VA 20116. above. In addition, one copy of any Topeka, Kansas 66612, Telephone: (785) (Catalog of Federal Domestic Assistance comments submitted to the FAA must 296–3285. SUPPLEMENTARY INFORMATION: The Program Number 20.205, Highway Planning be mailed or delivered to Greg W. and Construction. The regulations Campbell, Executive Director, FHWA, in cooperation with the Kansas implementing Executive Order 12372 Shenandoah Valley Regional Airport, at Department of Transportation (KDOT) regarding intergovernmental consultation on the following address: Greg W. and the Missouri Department of Federal programs and activities apply to this Campbell, Executive Director, Transportation (MoDOT), will prepare program.) Shenandoah Valley Regional Airport an environmental impact statement Issued on: May 19, 2004. commission, P.O. Box 125, Weyers (EIS) on a proposal to improve U.S. J. Michael Bowen, Highway 59 in Atchison County, Kansas Cave, VA 24486. Division Administrator, Kansas Division, and Buchanan County, Missouri. The FOR FURTHER INFORMATION CONTACT: Federal Highway Administration, Topeka, proposed project would involve Terry Page, Manager, Washington Kansas. improvement of the existing U.S. Airports District Office, 23723 Air [FR Doc. 04–11822 Filed 5–25–04; 8:45 am] Highway 59 corridor from the city of Freight Lane, Suite 210, Dulles, VA BILLING CODE 4910–22–P Atchison, Kansas over the Missouri 20166; telephone (703) 661–1354, fax River to the U.S. 59/State Route 45 (703) 661–1370, email Intersection in Buchanan County, [email protected]. DEPARTMENT OF THE TREASURY Missouri for a distance of about 6.3 SUPPLEMENTARY INFORMATION: On April kilometers (3.9 miles) in length. The Submission for OMB Review; 5, 2000, new authorizing legislation KDOT and MoDOT have coordinated Comment Request became effective. That bill, the Wendell with local officials and other interested H. Ford Aviation Investment and parties on the scope of the proposed May 18, 2004. Reform Act for the 21st Century, Public project. The Department of the Treasury has Law 10–181 (Apr. 5, 2000; 114 Stat. 61) Improvements to the corridor are submitted the following public (AIR 21) requires that a 30 day public considered needed to provide for the information collection requirement(s) to notice must be provided before the existing and projected traffic demands, OMB for review and clearance under the

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Paperwork Reduction Act of 1995, Public Law 104–13. Copies of the information collection requirement(s) to Public Law 104–13. Copies of the submission(s) may be obtained by OMB for review and clearance under the submission(s) may be obtained by calling the Treasury Bureau Clearance Paperwork Reduction Act of 1995, calling the Treasury Bureau Clearance Officer listed. Comments regarding this Public Law 104–13. Copies of the Officer listed. Comments regarding this information collection should be submission(s) may be obtained by information collection should be addressed to the OMB reviewer listed calling the Treasury Bureau Clearance addressed to the OMB reviewer listed and to the Treasury Department Officer listed. Comments regarding this and to the Treasury Department Clearance Officer, Department of the information collection should be Clearance Officer, Department of the Treasury, Room 11000, 1750 addressed to the OMB reviewer listed Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., and to the Treasury Department Pennsylvania Avenue, NW., Washington, DC 20220. Clearance Officer, Department of the Washington, DC 20220. DATES: Written comments should be Treasury, Room 11000, 1750 DATES: Written comments should be received on or before June 25, 2004 to Pennsylvania Avenue, NW., received on or before June 25, 2004 to be assured of consideration. Washington, DC 20220. be assured of consideration. Internal Revenue Service (IRS) DATES: Written comments should be received on or before June 25, 2004 to Financial Management Service (FMS) OMB Number: 1545–0915. OMB Number: 1510–0012. Form Number: IRS Form 8332. be assured of consideration. Form Number: FMS Form 6314. Type of Review: Extension. Internal Revenue Service (IRS) Type of Review: Extension. Title: Release of Claim to Exemption Title: Annual Financial Statements of for Child of Divorced or Separated OMB Number: 1545–1081. Surety Companies—Schedule F. Parents. Form Number: IRS Form 8809. Description: Surety and Insurance Description: This form is used by the Companies report information used to custodial parent to release claim to the Type of Review: Revision. compute the amount of authorized dependency exemption for a child of Title: Request for Extension of Time to reinsurance to determine Treasury divorced or separated parents. The data File Information Returns. Certified Companies’ underwriting is used to verify that the noncustodial Description: Form 8809 is used to limitations, which are published in parent is entitled to claim the request an extension of time to file Treasury Circular 570 for use by Federal exemption. certain information returns. It is used by bond approving officers. Respondents: Individuals or IRS to process requests expeditiously Respondents: Business or other for- households. and to track from year to year those who profit. Estimated Number of Respondents/ repeatedly ask for an extension. Estimated Number of Respondents: Recordkeeping: 150,000. 341. Estimated Burden Hours Respondent/ Respondents: Business or other for- Estimated Burden Hours Per Recordkeepers: profit, individuals or households, not- Respondent: 48 hours, 45 minutes. Recordkeeping—7 min. for-profit institutions, farms, Federal Frequency of Response: Annually. Learning about the law or the government, State, local or tribal Estimated Total Reporting: 14,458 form—5 min. government. hours. Preparing the form—7 min. Estimated Number of Respondents/ Clearance Officer: Jiovannah L. Diggs, Copying, assembling, and sending Recordkeeping: 50,000. (202) 874–7662, Financial Management the form to the IRS—14 min. Service, Administrative Programs Frequency of response: Annually. Estimated Burden Hours Respondent/ Division, Records and Information Estimated Total Reporting/ Recordkeepers: Management Program, 3700 East West Recordkeeping Burden: 82,500 hours. Recordkeeping—2 hr., 10 min. Highway, Room 144, Hyattsville, MD Clearance Officer: Glenn P. Kirkland, Learning about the law or the 20782. (202) 622–3428, Internal Revenue form—36 min. OMB Reviewer: Joseph F. Lackey, Jr., Service, Room 6411–03, 1111 (202) 395–7316, Office of Management Constitution Avenue, NW., Washington, Preparing and sending the form to and Budget, Room 10235, New DC 20224. the IRS—28 min. Executive Office Building, Washington, OMB Reviewer: Joseph F. Lackey, Jr., Frequency of response: On occasion. DC 20503. (202) 395–7316, Office of Management Estimated Total Reporting/ and Budget, Room 10235, New Lois K. Holland, Recordkeeping Burden: 162,500 hours. Executive Office Building, Washington, Treasury PRA Clearance Officer. DC 20503. Clearance Officer: Glenn P. Kirkland, [FR Doc. 04–11899 Filed 5–25–04; 8:45 am] (202) 622–3428, Internal Revenue BILLING CODE 4810–35–P Lois K. Holland, Service, Room 6411–03, 1111 Treasury PRA Clearance Officer. Constitution Avenue, NW., Washington, [FR Doc. 04–11900 Filed 5–25–04; 8:45 am] DC 20224. DEPARTMENT OF THE TREASURY BILLING CODE 4830–01–P OMB Reviewer: Joseph F. Lackey, Jr., Submission for OMB Review; (202) 395–7316, Office of Management and Budget, Room 10235, New Comment Request DEPARTMENT OF THE TREASURY Executive Office Building, Washington, May 18, 2004. Submission for OMB Review; DC 20503. The Department of the Treasury has Comment Request submitted the following public Lois K. Holland, information collection requirement(s) to May 19, 2004. Treasury PRA Clearance Officer. OMB for review and clearance under the The Department of the Treasury has [FR Doc. 04–11901 Filed 5–25–04; 8:45 am] Paperwork Reduction Act of 1995, submitted the following public BILLING CODE 4830–01–P

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Part II

Environmental Protection Agency 40 CFR Part 52 Approval and Promulgation of Implementation Plans for California – San Joaquin Valley PM–10 Nonattainment Area; Serious Area Plan for Attainment of the 24-Hour and Annual PM–10 Standards; Final Rule

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ENVIRONMENTAL PROTECTION II. Public Comments and EPA Responses • A demonstration that reasonably AGENCY A. NOX/PM Strategy available and best available control 1. Ammonia measures (RACM and BACM) will be 40 CFR Part 52 2. VOC expeditiously implemented for all 3. SOX [CA 294–0450, FRL–7663–8] B. Emission Inventory significant sources of PM–10 and PM– 10 precursors; C. BACM Demonstration • Approval and Promulgation of 1. Commitments for BACM/BACT A demonstration that attainment will Implementation Plans for California— 2. Agricultural Conservation Management be achieved as expeditiously as San Joaquin Valley PM–10 Practices (Ag CMP) Program practicable; Nonattainment Area; Serious Area Plan 3. Ag Crop Processing Losses and Ag • A demonstration that the CAA section for Attainment of the 24-Hour and Products Processing Losses 189(d) five percent requirement is Annual PM–10 Standards 4. Plastics and Plastic Products met; and Manufacturing Sources • A demonstration that reasonable AGENCY: Environmental Protection 5. Cotton Gins further progress (RFP) and Agency (EPA). 6. Manufacturing and Industrial Fuel quantitative milestones will be ACTION: Final rule. Combustion Sources 7. Oil Drilling and Workover achieved. SUMMARY: EPA is finalizing approval of 8. Residential Water Heaters A detailed discussion of air quality the ‘‘2003 PM10 Plan, San Joaquin 9. Charbroiling planning in the SJV, the CAA Valley Plan to Attain Federal Standards 10. Regulation VIII Fugitive Dust Sources requirements for serious nonattainment for Particulate Matter 10 Microns and 11. Significant Sources of VOC, Ammonia areas, and how the 2003 PM–10 Plan and SOx complies with these requirements is Smaller,’’ submitted on August 19, 12. Mobile Sources—Transportation 2003, and Amendments to that plan, provided in our proposed rule and the Control Measures (TCMs) technical support document (TSD). submitted on December 30, 2003, as 13. Mobile Sources—South Coast Fleet and meeting the Clean Air Act (CAA or the Low Sulfur Diesel Rules II. Public Comments and EPA Act) requirements applicable to the San D. Attainment Demonstration Responses Joaquin Valley, California 1. Attainment Deadline nonattainment area for particulate 2. Attainment Demonstration EPA received 19 comment letters and matter of ten microns or less (PM– Overestimates Emission Reductions emails from the following 10)(SJV). The SJV violates the national 3. Attainment as Expeditiously as environmental groups, industry groups, ambient air quality standards (NAAQS) Practicable agencies and public citizens (some E. Five Percent Demonstration commenters provided more than one for PM–10 and is classified as a serious F. RFP Demonstration PM–10 nonattainment area. letter or email): G. Contingency Measures • As a serious PM–10 nonattainment H. Full Approval with Commitments Dr. David Pepper area, the State must submit to EPA a • Gordon Jones, Tehachapi, California Violates the CAA • plan that provides for, among other I. Adoption of All Feasible Measures Michael E. LaSalle, Hanford, things, the implementation of best (Section 179(d)(2)) for Ag CMP Program California • available control measures (BACM). In J. Approval of Commitments for VOC Brent Newell, Stacey Wittorf, Center addition, because the serious attainment Sources—Wineries on Race, Poverty, & the Environment deadline, December 31, 2001, has K. Approvability of Indirect Source (CRPE) on behalf of the Association of passed, the plan must provide for Mitigation Measure Irritated Residents (collectively, L. Windblown Dust Issues expeditious attainment of the PM–10 CRPE) M. Transportation Conformity and the • Art Caputi, Chairman, Wine Institute NAAQS and for an annual reduction in Trading Mechanism PM–10 or PM–10 precursor emissions of Air Quality Working Group N. Other Comments • D. Barton Doyle, on behalf of the not less than five percent until III. EPA Action attainment. IV. Statutory and Executive Order Reviews California Building Industry Association and its Affiliate DATES: Effective Date: This rule is I. Summary of Proposed Actions Associations located in the SJV effective on June 25, 2004. • On February 4, 2004, (69 FR 5412), we Suzanne Noble, Western States ADDRESSES: You can inspect copies of proposed to approve the ‘‘2003 PM10 Petroleum Association the docket for this action at EPA’s • Plan, San Joaquin Valley Plan to Attain Jan Marie Ennenga, Executive Region IX office during normal business Federal Standards for Particulate Matter Director, Manufacturers Council of hours by appointment at the following 10 Microns and Smaller,’’ submitted on the Central Valley locations: Environmental Protection • David L. Crow, Executive Director/Air August 19, 2003, and Amendments to Agency, Region IX, 75 Hawthorne Pollution Control Officer, San Joaquin that plan, submitted on December 30, Street, San Francisco, CA 94105–3901. Valley Unified Air Pollution Control 2003,1 as meeting the CAA requirements Air and Radiation Docket and District (SJVUAPCD or the District) applicable to the SJV for PM–10. Information Center, U.S. Environmental • Patricia Taylor-Maley, Chair San Specifically, we proposed to approve Protection Agency, Room B–102, 1301 Joaquin Valley TPA Director’s the following elements of the Plan: Constitution Avenue, NW., (Mail Code Association • 6102T), Washington, DC 20460. Motor vehicle budgets for • Charles Swanson, San Francisco, transportation conformity; FOR FURTHER INFORMATION CONTACT: California • • Doris Lo, EPA Region IX, (415)972– Emissions inventories for PM–10 and David Moralez, Davis, California • 3959, [email protected]. PM–10 precursors; Susan Britton, Anne Harper and Vanessa E-H Stewart, Earthjustice, on SUPPLEMENTARY INFORMATION: 1 Throughout this document, ‘‘we,’’ ‘‘us’’ The Amendments to the 2003 PM–10 supersede behalf of Medical Advocates for some portions of the 2003 PM–10 Plan and also add Healthy Air, Latino Issues Forum, and ‘‘our’’ refer to EPA. to it. References hereafter to the ‘‘SJV 2003 PM–10 Plan’’ or ‘‘the Plan’’ mean the 2003 Plan submitted Sierra Club and Natural Resources Table of Contents on August 19, 2003, as amended by the December Defense Council (collectively, I. Summary of Proposed Actions 30, 2003 submittal. Earthjustice)

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• Barbara Joy, Earth Matters that the results of the CRPAQS study and that controlling ammonia in • San Joaquin Valley agricultural will provide additional technical addition to NOX will not accelerate the groups: California Cotton Ginners and information and is approving the attainment date for PM–10 in the SJV. Growers Association, California Grape SJVUAPCD’s commitment to re-evaluate EPA also believes that the effect of and Tree Fruit League, California the 2003 PM–10 Plan with the results of controlling ammonia on ammonium Citrus Mutual, Fresno County Farm CRPAQS and to submit a new plan to nitrate is less clear than the effect of Bureau, Kings County Farm Bureau, EPA by March 2006. (69 FR 5412, 5414). controlling NOX at this time, for several Madera County Farm Bureau, Nisei The attainment demonstration for the reasons. The current emission inventory Farmers League and Tulare Lake Plan is based on receptor modeling and control strategies for ammonia have Resource Conservation District. based on chemical analysis of filter a greater uncertainty than the NOX EPA appreciates the time and effort samples collected during the CRPAQS emission inventory and control made by the commenters in reviewing field study. These samples include strategies. For NOX, the control the proposed rule and providing filters from days representing typically technology and management practices comments. We have summarized the high PM–10 concentrations in the SJV. are better understood and well major comments and provided our However, the photochemical grid established. In addition, analysis of responses below. modeling, UAM-Aero, presented in the ambient air quality data in the SJV Plan was based on the previous, smaller A. NO /PM Strategy indicates that ammonia is relatively X field study in the SJV, IMS 95, because abundant throughout the SJV and, The Plan relies on an oxides of the modeling from the CRPAQS field therefore, controlling ammonia in nitrogen (NOX)/PM strategy as the most study was not complete at the time of addition to NOX controls, will not effective and expeditious strategy for the Plan approval. The proposed effectively reduce ammonium nitrate, attaining the PM–10 standards in the modeling analysis based on CRPAQS because it is not the limiting pollutant. SJV, based on the best available will better characterize the interaction As discussed below, the current data information at this time. The California of precursors to form secondary suggest that controlling ammonia may Air Resources Board (CARB) and the particulates, because of the more robust be neither an efficient nor an effective SJVUAPCD have examined the effects of CRPAQS database and the more approach to reducing ammonium nitrate controlling ammonia, volatile organic extensive CRPAQS modeling approach. concentrations in the SJV. compounds (VOC) and oxides of sulfur Responses to comments regarding As discussed elsewhere in response to (SOx), and have determined that the individual precursors are addressed comments on the emissions inventory, effect of controls for ammonia is below. EPA believes that the Plan’s emissions uncertain, the effect of additional VOC 1. Ammonia inventory for ammonia reflects the controls will not lead to PM–10 current state of scientific knowledge. reductions throughout the SJV, and that Comment 1: Earthjustice comments EPA also believes, however, that both the effect of SOx controls would be very that all available evidence supports that ammonia emission factors and ammonia limited because the contribution of ammonium nitrate is a significant source surveys, and thus the ammonia ammonium sulfate to the particulate contributor to fall and winter PM inventory itself, have a high degree of problem in the SJV is small. EPA exceedances. CRPE comments that uncertainty. This is because the concurs that these findings are ammonium nitrate represents a ammonia inventory is dominated by supported by the current analysis of the significant amount of the total PM–10 emission sources—such as dairy, beef, best available data. However, the more concentration, and represents the largest poultry, fertilizer, and soil—that have extensive California Regional PM–10/ amount of PM–10 during the winter. not been extensively sampled in the PM–2.5 Air Quality Study (CRPAQS) CRPE comments that the Plan itself past, and that are inherently difficult to field study and modeling will provide concedes that ammonia reacts with measure even with the most an improved basis to assess the other precursor emission to form sophisticated and expensive relationship of precursors in forming ammonium nitrate during the winter. techniques.3 This sharply contrasts with secondary particulates.2 EPA expects Response: EPA concurs that the confidence level associated with ammonium nitrate is a significant quantifying emissions of NOX, a gas 2 The CRPAQS study was an extensive 14-month contributor to violations of both the 24- field study conducted on 2000–2001, which which is emitted primarily by stationary measured PM–10, precursors and meteorological hour and annual PM–10 standards in and mobile source combustion and parameters during episodes representative of high the SJV. Ammonium nitrate, a which can therefore be accurately PM–10 and PM–2.5 in the SJV. The domain for the secondary particulate, is not directly measured through stack or tailpipe tests. study encompasses the entire SJV, compared to the emitted, but formed as a product of a smaller IMS 95 domain of an earlier field study, and For example, a calculation of net the CRPAQS study captured more extensive series of chemical reactions which ammonia emissions from soil would ambient air and meteorological measurements than involve ammonia (NH3), NOX, and need to measure on a seasonal basis the IMS 95 field study. The CRPAQS modeling, many other components. EPA believes both ammonia emissions and ammonia discussed below, will be more extensive than the that the Plan will effectively reduce Urban Airshed Model-Aerosol (UAM–Aero) uptake considering such factors as soil modeling based on IMS 95. Additional information ammonium nitrate by controlling NOX, regarding the CRPAQS study is available at http: 3 Surface isolation flux chambers are generally //www.arb.ca.gov/airways/ccaqs.htm. The first type of modeling approach explicitly used to collect field samples of ammonia sources. The goal of the CRPAQS modeling is to better tracks particle types from individual source types. These samples are then evacuated for laboratory understand the fundamental physical and chemical This method has strong advantages in analysis. For livestock waste, the flux chambers processes that contribute to elevated particulate understanding source-receptor relationships and in need to be stationed at representative locations to matter concentrations. The CRPAQS modeling tracking specific source contributions to secondary sample liquid and solid waste at various ages and package includes evaluation of two complementary particulate matter. However, this approach can be under various exposure conditions. See ‘‘Results of modeling approaches. Each model provides very resource and time intensive to apply. The the Measurement of PM10 Precursor Compounds particular strengths that will support state second modeling approach lumps similar pollutant from Dairy Industry Livestock Waste,’’ Air Toxics implementation plan (SIP) modeling needs. In emissions together, thus reducing source tracking Limited, C.E. Schmidt and E. Winegar, June 1996. addition, use of two modeling approaches allows capabilities. The advantage of this approach is that This report was prepared for the South Coast Air improved diagnosis of potential model errors and it requires fewer resources to run, enabling many Quality Management District (SCAQMD), and is biases. The two modeling approaches have more sensitivity and control strategy evaluations to currently available at: http://www.aqmd.gov/rules/ fundamentally different modeling formulations. be conducted. proposed/r1127/index.html.

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type, climatic variables, soil moisture, control technologies and control ammonium nitrate and sulfate vegetative coverage, etc. The accurate techniques at this time, and no extended formation, CARB concluded that there quantification of livestock emissions record documenting the actual costs and was no ambient ammonia deficiency depends on survey data and emissions benefits of regulatory control programs during the IMS 95 episode.6 Hence, measurement on a seasonal basis of in effect for ammonia. Moreover, the ammonia is in excess and initial various animal types, ages, and costs and benefits of most ammonia reductions in ammonia concentrations residency times; animal and waste control approaches must be assessed on will not reduce ammonium nitrate. handling practices (such as types of a region-specific basis, since the Independent data analysis performed by commercial feed or range feeding, stable assessment would need to take into Dr. Chu at EPA concluded that ‘‘the housing, manure spreading, and waste account fundamental differences from high ammonium nitrate particle storage); climatic and soil variables, one area to another in terms of the concentrations observed in the winter in etc.4 affected industries, the availability of San Joaquin Valley are not limited by These difficulties and complexities in control options, and variations in the available ammonia emissions.’’ 7 quantifying baseline ammonia critical conditions, such as soils and soil Preliminary data analysis from the emissions, particularly over an area as coverage, temperature, windspeed, and CRPAQS study also indicates that large and diverse as the SJV, make it humidity.5 ‘‘nitrate formation in the San Joaquin difficult to quantify the benefits of Data analysis for the SJV indicates Valley Air Basin (SJVAB) is not likely to possible ammonia control strategies. In that the Valley is relatively rich in be limited by ammonia availability.’’ 8 addition, although there are many ammonia and, therefore, reductions of The NARSTO assessment likewise groups now assessing various ammonia ammonia are not likely to be effective. concludes that for the San Joaquin emission reduction approaches, there Data analysis is based on measured Valley ‘‘[t]here is typically an are few completed scientific studies of concentrations of precursors in the abundance of NH3 present.’’ 9 the potential effectiveness of ammonia ambient air. Therefore, despite the Although the UAM-Aero modeling uncertainties in the emission inventory, presented in the plan indicates that 4 For a discussion of these and other challenges data analysis can provide an ammonia reductions may result in lower associated with quantifying livestock emissions in understanding of the relationship of the concentrations of ammonium nitrate California and the progress to date in addressing the issues, see: ‘‘Air Emissions Action Plan for concentrations of the precursors in an (secondary PM) in some areas of the California Dairies’’, a report of the Ad hoc Dairy area, and the effect of control strategies SJV, because of the uncertainty in the Subcommittee of the San Joaquin Valley Unified of precursors will have on the ammonia inventory and the atmospheric Air Pollution Control District. (May 2003, available concentration levels of ammonium chemistry, State and local air agency at: http;//www.arb.ca.gov/planning/agriculture/ cafowg/dairy062503.pfd., Memo from Patrick nitrate. Ammonium nitrate is a experts question these results. This is Gaffney, ARB, entitled ‘‘Updating Livestock secondary pollutant formed through the discussed in greater detail in the Emissions for California’’ (October 1, 2003); and neutralization of nitric acid by response to comment 9 below. ARB’s ‘‘Interim Draft Livestock Husbandry’’ ammonia. Based on a molar comparison Finally, EPA is also concerned that emissions factors (October 2003), both available at: http://www.arb.ca.gov/emisinv/areasrc/ of the observed ion data, the amount of there is uncertainty about the effects of drftmeth.htm. The last of these documents ammonium needed if all the sulfate and ammonia controls in areas such as SJV summarizes the current state of knowledge relating nitrate were ammonium sulfate and that have conditions conducive to the to livestock emissions: ‘‘Currently, there are not ammonium nitrate can be calculated. In formation of acid fog. In such places, TOG [total organic gases] or ROG [reactive organic gases] emission factors for livestock that are based an area where ammonia concentrations reductions of ammonia might serve to on recent or California specific test data. However, are high relative to the concentrations of increase the exposure to a category of even in the absence of good quality emission nitric acid (which is produced from PM–2.5 known as acid aerosols. factors, it is necessary to estimate livestock TOG NOX and VOC), reducing ammonia will Historical and present-day evidence and ROG emissions. In order to meet the regulatory requirements for livestock emission estimates, not effectively reduce ammonium suggests that acid aerosols may have interim emission factors were used. These factors nitrate. In areas where the ammonia both acute and chronic effects on are quite old, have many shortcomings, and have concentrations are relatively low, human health.10 very little field or laboratory data to support them. reducing ammonia concentrations will These fundamental scientific and The current emission estimates are intended as placeholders to help begin identifying the gross effectively reduce ammonium nitrate. technical uncertainties regarding magnitudes of livestock air emissions.’’ (Page x.xx– Data analysis results from several ammonia leave reasonable doubts 2). See also a report commissioned by the investigators support the conclusion regarding the extent to which ammonia SCAQMD: ‘‘Literature Survey & National that SJV is ammonia rich. Based on the reductions would contribute to PM–10 Programs—Livestock Waste Management Practices Survey & Control Option Assessment,’’ Tetra Tech, thermodynamic equilibrium of attainment in the SJV. The CRPAQS Inc., March 2003. This SCAQMD report is currently should resolve the question of whether available at the Web address in the previous 5 As part of a lengthy rule development process, ammonia and other possible precursors, footnote. Additional information on ammonia the SCAQMD has collected information on the costs including VOC and SO , contribute emissions from animal husbandry operations can be and benefits of reducing ammonia emissions from X found in EPA’s recently released draft report composting and from livestock waste within the significantly to PM–10 levels which entitled, ‘‘National Emissions Inventory—Ammonia South Coast (metropolitan Los Angeles area), exceed the standard in the SJV. In the Emissions from Animal Husbandry Operations.’’ evaluating in particular those control approaches The draft report includes emission estimates from reflected in the SCAQMD’s Rules 1133, 1133.1, and 6 Plan at M–11. animal production facilities in the U.S. for the years 1133.2 (a series of composting rules adopted on 7 2002, 2010, 2015, 2020, and 2030. While the data January 10, 2003) and in SCAQMD’s proposed rule Shao-Hang Chu, Wintertime PM formation in updates past emission estimates, there are 1127 (livestock waste). See, for example, ‘‘Survey San Joaquin Valley. Memorandum to Doris Lo, important limitations on the use of the data, Current Livestock Waste Management Practices in December 2003. including the limited number of emission the South Coast Air Basin,’’ Tetra Tech, Inc., 8 Lurmann et al., in ‘‘Phase Distributions and measurements. The draft report can be found at— January 2002; and SCAQMD ‘‘Preliminary Draft Secondary Formation During Winter in the San http://www.epa.gov/ttn/chief/net/ Staff Report: Proposed Rule 1127—Emission Joaquin Valley’’. 2002inventory.html#animal Reductions from Livestock Waste,’’ November 20, 9 NARSTO at 10–12. While the data updates past emission estimates, 2002. These reports are currently available at the 10 EPA has discussed its concerns with respect to there are important limitations on the use of the web address in the footnote above. Although some exposure to acid aerosols in more detail in the data, including the limited number of emission of this information may be applicable to the SJV, criteria document for the new PM–2.5 NAAQS. See, measurements. The draft report can be found at— much of the data is specific to the South Coast and U.S. EPA, Air Quality Criteria for Particulate http://www.epa.gov/ttn/chief/net/ would need to be replaced with SJV data during a Matter, vol. III at 12–253, April 1996 (EPA/600/P– 2002inventory.html#animal. rulemaking process. 95/0001cF).

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absence of the CRPAQS results, EPA reduce ammonium nitrate. Therefore, Plan supports the conclusion that NOX believes that there is insufficient EPA believes that the Earthjustice reductions are the most effective evidence to support a determination calculation determining the ammonia strategy in rural areas at current levels that ammonia is a significant PM–10 contribution to ammonium nitrate for of ammonia. The full context of the precursor in the SJV. Thus, EPA is the purpose of determining significance remark that the commenter points to is: making the Agency’s determination is not appropriate. ‘‘The rural sites show sensitivity to only under CAA section 189(e) that sources Comment 3: Earthjustice comments NOX reductions until the ammonia of ammonia do not contribute that more than 151,000 tons of ammonia concentrations are very low. After that significantly to PM–10 levels which are emitted from Valley sources and that point the response becomes insensitive exceed the standard in the SJV. If the ammonia must be regulated because to NOX controls and almost entirely CRPAQS shows that ammonia is a EPA’s guidance, CAA section 189(e) and responsive to ammonia controls at 11 significant precursor, however, EPA will the District’s own data show that it is a higher NOX emissions.’’ According to reevaluate this determination. At that significant contributor. the information presented in Figure 6 of point, ammonia could become subject to Response: As stated above, EPA Appendix M–11 of the Plan, only after the various PM–10 and PM–10 believes that the most effective way to ammonia concentrations are reduced to precursor control provisions of the reduce ammonium nitrate is by a very low level do the ammonia Clean Air Act, including BACM under controlling NOX. As discussed in the controls become effective. Therefore, section 189(b)(1)(B) and the 5 percent above response, EPA is determining, large reductions of ammonia would be requirement under section 189(d). based upon the best currently available required before ammonia reductions In the proposed rule, EPA concurred information, that ammonia does not would become more effective than NOX with the 2003 PM–10 Plan’s NOX/PM contribute significantly to PM–10 levels controls in reducing ammonium nitrate. strategy based on the currently available which exceed the standard in the SJV. This is not the same thing as saying that information which includes a high If the results of CRPAQS indicate ammonia reductions are the most degree of uncertainty regarding the otherwise, EPA will revisit this effective or efficient means to attain the ammonia inventory and the effects of determination. PM–10 NAAQS expeditiously, which is ammonia controls. EPA agrees with the Comment 4: Earthjustice comments the goal of the Plan. State and local agencies that this that the District’s decision not to Comment 6: Earthjustice comments approach will not retard air quality regulate PM–10 precursors other than that one of the District’s rationales for progress in the SJV. The SJVUAPCD has NOX is based on results of sensitivity not regulating ammonia is that ‘‘there is made an enforceable commitment to tests using the UAM-Aero to model the too much uncertainty regarding the submit a SIP revision by 2006 based on formation of secondary particles in the effects of ammonia controls.’’ Plan at the CRPAQS results, including atmosphere. The Plan admits the data ES–16. This is unsupported by facts and appropriate controls based on those set was not ideal. EPA itself has commissioned studies results. 69 FR 5412, 5414. In the Response: EPA concurs that the data documenting control efficiencies for meantime, the area should achieve set used for the UAM-Aero modeling various types of equipment designed to important reductions in ammonium was not ideal; however, it was the best control emissions of ammonia. nitrate PM–10 concentrations through a available data set at the time of the Plan Response: EPA cannot find the same NOX-based strategy. Finally, EPA submittal and was sufficient to make the quote cited by Earthjustice at ES–16. On continues to believe that use of the necessary determination. In addition, page ES–16, the Plan states that there is CRPAQS has the potential to avoid the determination of the efficacy of ‘‘* * * uncertainty regarding ammonia wasteful imposition of controls that may ammonia control was based on data emission controls to achieve attainment be found to be not only expensive and analysis (Plan at Appendix M, M–11). * * *,’’ but EPA does not agree that the dislocative but also unnecessary and This includes the preliminary data District is questioning the control ineffective in advancing PM–10 analysis based on the CRPAQS study, efficiencies of the controls themselves attainment in the specific circumstances which captured high values of PM–10 on this page. As discussed above, applicable in the SJV. and ammonium nitrate, and supports however, EPA believes that there are Comment 2: Earthjustice comments the conclusion that the SJV ammonium some uncertainties concerning ammonia that if ammonia comprises 22.4% of the nitrate concentrations are not sensitive that support the District’s position that total mass of ammonium nitrate, this to reductions in ammonia. Modeling it may be better to focus on NOX means that ammonia is contributing based on the more extensive CRPAQS reductions at this time. anywhere from 13 µg/m3 to 22.4 µg/m3 field program will not be available until Comment 7: Earthjustice comments to total mass at each monitoring site. late 2005. As stated above, EPA believes that livestock waste is responsible for Response: Ammonium nitrate is a that controlling NOX will effectively approximately 85% of ammonia secondary particulate, a product of reduce ammonium nitrate. The District emissions in the Valley. Sources of chemical reaction. Although ammonia has made an enforceable commitment to livestock waste must be presumed to participates in the series of reactions to reevaluate the 2003 PM–10 Plan with contribute significantly to violations of form ammonium nitrate, it is not the results of CRPAQS and to submit a the NAAQS because the contribution to appropriate to determine the new plan to EPA by March 2006. the PM–10 impact in these areas is more significance of the ammonia Comment 5: Earthjustice comments than double EPA’s standard of 5 µg/m3 contribution to ammonium nitrate in that the Plan states that ‘‘In rural sites for the 24-hour average at every site. In isolation. The effect of ammonia where the ammonia concentrations are addition, Earthjustice states that emissions on the formation of low, the Plan further admits that SCAQMD Rules 1186 and 1127 reduce ammonium nitrate is specific to each air reductions of PM–10 almost entirely emissions from livestock waste and basin. As presented in the response to depend on ammonia controls.’’ should be included in a BACM analysis comment 1 above, EPA believes that the Response: EPA believes that the for this source category. Plan will effectively reduce the commenter is misinterpreting the Response: As discussed in above concentration of ammonium nitrate in explanation of the graphic responses, EPA has determined that the SJV by controlling NOX, and that representation of the reduction controlling ammonia will not effectively strategies presented in the Plan. The 11 Plan at Appendix M–11.

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ammonia does not contribute Earthjustice comments that the Plan and to submit a new plan to EPA by significantly to PM–10 levels which admits that the UAM-Aero model shows March 2006. exceed the NAAQS in the SJV. In that the ‘‘southern Valley shows a non- Comment 11: The SJVUAPCD addition, although the South Coast and negligible sensitivity to ammonia comments that Lurmann et al., in SJV air basins each have relatively high reduction.’’ CRPE comments that ‘‘Phase Distributions and Secondary levels of ammonium nitrate, the ammonia controls are equally effective Formation During Winter in the San difference in the relative emission levels as NOX controls in reducing ammonium Joaquin Valley’’ noted that nitrate of precursors and the atmospheric nitrate in Fresno and Bakersfield. formation in the San Joaquin Valley Air conditions unique to each basin may Response: The Plan at the section Basin is not likely to be limited by lead to different optimal control entitled ‘‘Further Investigations to ammonia availability. Although these strategies for each basin. EPA also notes Assess Apparent Ammonia Limitation results are preliminary, they are that the SCAQMD does not claim at Bakersfield on January 6, 1996’’ 12 included here because they strongly ammonia reductions from Rule 1186, discusses the apparent disparity support the peer-reviewed journal which is designed to reduce fugitive between the results of the data analysis articles referenced above. CRPAQS data dust, and SCAQMD has not yet adopted and the modeling. Based on the analysis is now underway, with results Rule 1127, which is currently scheduled thermodynamic equilibrium of due in 2005. for Board consideration in July 2004. ammonium nitrate and sulfate Response: EPA agrees that this paper Comment 8: CRPE comments that the formation, the data analysis results represents the most current data standard for requiring PM–10 precursor indicate that there was no ambient analysis for the CRPAQS study, and controls is not whether precursor ammonia deficiency at Bakersfield supports the conclusion of the previous reductions effectively reduce PM–10, during the IMS 95 episode. The Plan data analysis results that the NOX but rather whether the precursor itself indicates that ‘‘[b]ased on sensitivity strategy is the most effective approach contributes significantly to violations of simulations we performed, we believe to reduce ammonium nitrate in the SJV. the PM–10 NAAQS. Earthjustice that this apparent ammonia limitation is 2. VOC comments that in its Addendum, EPA due to the artificially low ammonia Comment 1: Earthjustice comments states that a source category ‘‘will be emissions in the Southern San Joaquin presumed to contribute significantly to that the proposal to determine that Valley.’’ Because of the uncertainties in VOCs ‘‘do not significantly contribute’’ a violation of the 24-hour NAAQS if its the ammonia emission inventory at this PM–10 impact at the location of the to PM–10 NAAQS exceedances is µ time, EPA believes that reliance on the inappropriate because it is based on the expected violation would exceed 5 g/ ambient data analysis is more 3 UAM–Aero modeling which relies on m .’’ Addendum at 42011. Earthjustice appropriate at this time. EPA expects also comments that the Clean Air Act three days of data from 1996, during a that the results of the CRPAQS study period of unusually low PM levels. requires the regulation of major will provide additional technical stationary sources of PM–10 precursors Response: EPA agrees that the IMS 95 information and is approving the database is not ideal; however, it was (CAA 189(e)) and that, like the South SJVUAPCD’s commitment to re-evaluate Coast, the SJV should take the prudent the best available data set at the time of the 2003 PM–10 Plan with the results of approach of regulating ammonia given the Plan submittal. The modeling CRPAQS and to submit a new plan to the uncertainty. presented in the Plan is based on the Response: As discussed in above EPA by March 2006. (69 FR 5412, 5414). time period most representative of high responses, EPA is determining that Comment 10: The SJVUAPCD PM–10 during the IMS 95 Study. ammonia does not contribute comments that according to the Plan, Modeling based on the more extensive significantly to PM–10 levels which the preponderance of evidence indicates CRPAQS field program will not be exceed the standard in the SJV. excess ammonia in nearly all of the available until late 2005. The District Although ammonium nitrate cases, and therefore NOX-only control has made an enforceable commitment to concentrations in the Valley are was determined to be the appropriate reevaluate the 2003 PM–10 Plan with substantial, as discussed above, EPA has means to reduce ammonium nitrate. the results of CRPAQS and to submit a Peer-reviewed scientific journal articles determined that NOX control is the most new plan to EPA by March 2006. effective way to achieve the PM–10 and papers submitted to EPA as part of The District’s UAM–Aero modeling NAAQS. In addition, the commenter the SIP package for the PM–10 Plan was used to determine the sensitivity of refers to the Addendum test for whether support this position. The paper by ammonium nitrate to VOC controls a source is presumed to be significant. Kumar, et al. (Analysis of Atmospheric (whether VOC controls would increase That is not necessarily the test for Chemistry During 1995 Integrated or decrease the ammonium nitrate in the whether a particular precursor is Monitoring Study) found that of the 150 SJV). The chemical nature of the significant. Although the SJV and the samples, 93% were ammonia rich. atmosphere is not likely to significantly South Coast air basins each have Response: For the reasons stated change from one winter period to relatively high concentrations of above in the response to comment 1, another and, therefore, the response of ammonium nitrate, the meteorology and EPA concurs with the SJVUAPCD that the atmosphere to reductions in VOC the emissions of each basin are current evidence supports that NOX during the IMS 95 time period is likely different, leading to potentially different controls are the most effective approach to be similar to the response in different strategies in reducing ammonium to reducing ammonium nitrate in the winter time periods. Therefore, despite nitrate. See responses in this section SJV. EPA expects that the results of the the fact that the PM–10 levels were above and the District’s ‘‘Responses to CRPAQS study will provide additional relatively low, the IMS 95 modeling is Comments on the Draft 2003 Pm10 technical information regarding the useful to determine the relative impact Plan,’’ #34. formation of ammonium nitrate in the of VOC controls on the formation of Comment 9: CRPE comments that the SJV. EPA is approving the SJVUAPCD’s ammonium nitrate. Plan states that for Bakersfield on commitment to re-evaluate the 2003 As part of the technical support for January 6, 1996, reductions of NOX and PM–10 Plan with the results of CRPAQS the Plan, CARB determined the ammonia are nearly equally effective in expected response to emission reducing nitrate concentrations. 12 Plan at Appendix M–11. reductions through modeling. The

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sensitivity of ammonium nitrate Plan’s more refined modeling, based on not be sensitive to ammonia concentrations to VOC controls is the IMS 95 study, discussed above, concentrations and may be sensitive to presented in the Plan (Appendix M, M– indicates that ammonium nitrate VOC, each of these conclusions is 6). A 50% reduction of VOCs results in concentrations are not very sensitive to subject to the limitations of the only a small reduction of ammonium VOC control (Plan at Appendix M, M– investigation. EPA concurs that it is nitrate concentrations throughout the 6) in the SJV. In other words, VOC important to extend this analysis to a modeling domain. Plan at Appendix M, controls will not have as great an effect three dimensional modeling study using M–10. This suggests that even with large on PM formation. The CRPAQS study a more extensive database. In the Plan, reductions of VOC concentrations, the should provide an improved database CARB has presented a more refined reduction of the concentrations of for more definitive results regarding the modeling analysis based on a three- ammonium nitrate will be small. effect of VOC controls in reducing PM– dimensional model. The results of that Comment 2: Earthjustice comments 10 in the SJV. modeling exercise indicate that nitrate that there is evidence that VOCs have Comment 3: Earthjustice comments concentrations are not very sensitive to much to do with facilitating the rate of that the NARSTO report indicates ‘‘In VOC concentrations (Plan at Appendix PM formulation in the Valley. To the case of secondary winter PM nitrate M, M–6). Therefore, control of VOC will support this argument, Earthjustice in the SJV * * * nitrate formation is not be as effective as NOX control. The refers to an analysis by Pun and thought to be sensitive to VOC forthcoming CRPAQS database will Seigneur, (Pun and Seigneur C, concentrations in many urban areas.’’ provide a more extensive, reliable Conceptual Model of Particulate Matter The report opines: database to support additional

Pollution in the San Joaquin Valley. Reductions in NOX may not be the best modeling. EPA expects that the September 8, 1998 at 3–12). course of action for reducing particulate modeling results of the CRPAQS study Response: EPA agrees that VOC plays nitrate in the possible VOC-sensitive will provide additional technical a role in the formation of ammonium wintertime condition. Box model simulations information and is approving the nitrate in the Valley. However, EPA indicate that NOX reductions may have the SJVUAPCD’s commitment to re-evaluate believes that the control of VOC is not counterintuitive effect of increasing the 2003 PM–10 Plan with the results of an effective method to reduce particulate nitrate formation during winter (Pun and Seigneur, 2001). Therefore, CRPAQS and to submit a new plan to ammonium nitrate in the SJV. EPA has coordinated efforts will be required to EPA by March 2006. 69 FR 5412, 5414. examined the analysis by Pun and formulate control strategies beneficial to both Comment 4: Earthjustice comments Seigneur, as well as other material, in ozone and PM air quality. that the VOC emissions are probably considering the efficacy of a VOC Response: We believe that the underestimated for the SJV and that it control strategy in the SJV. The Pun and NARSTO report’s conclusions are is irresponsible of the Plan to not Seigneur conceptual model is also based subject to several limitations. They are include controls for livestock waste, a on the IMS 95 database, and is therefore based on ‘‘Sensitivity of Particulate significant VOC source, when the subject to the same limitations as the Matter Nitrate Formation to Precursor negative effects of VOC pollution are photochemical modeling used in the Emissions in the California San Joaquin well-known. Furthermore, Earthjustice Plan. In addition, Pun and Seigneur is Valley,’’ Pun and Seigneur, 2001.13 As points out that the South Coast Air based on a less sophisticated box model, mentioned above, this study is based on Quality Management Plan relies on VOC and is subject to the limitations of a box the IMS 95 field study and therefore is reductions to attain the PM–10 standard model, compared to the more refined subject to the same database limitations and that the SJV should, as the South grid model, UAM–Aero, presented in as the UAM–Aero modeling included in Coast has, take the prudent course of the 2003 PM–10 Plan. The commenter the Plan. In addition, Pun and Seigneur, action by including VOC reductions. overstates the conclusion of Pun and 2001 is based on a less sophisticated Response: As discussed above, EPA Seigneur with respect to the efficacy of box model, and is subject to the has determined that for the purposes of VOC control. Although the paper states limitations of a box model compared to section 189(b)(1)(B) and (e), VOC does that the basin may be either NOX or the more refined grid model, UAM– not contribute significantly to PM–10 oxidant sensitive, it does not conclude Aero, presented in the 2003 PM–10 levels which exceed the standards in the which of the precursors is most plan. Pun and Seigneur conclude: SJV. While the South Coast and the SJV influential in the SJV: It should be noted that the box model each have a high level of ammonium The ambient formation of HNO3 may be represents some domain-average chemistry nitrate, the air basins are quite different either NOX or oxidant sensitive. Although but cannot characterize the locally specific in terrain, meteorology, and emissions. information regarding the dominant reaction chemical regimes. Other assumptions include In addition, the South Coast is primarily was not available, indirect evidence from the stagnant conditions and aloft carry-overs of an urban area, while the SJV is a mix of diurnal profile of total nitrate (peak gaseous and PM pollutants. Further work should extend this box model analysis to a rural and urban areas. Differences in concentrations in the afternoon) seemed to relative emissions of precursors and the indicate that the NO2 + OH reaction was an three-dimensional modeling study so that important nitric acid production route. Thus transport processes can be simulated and the atmospheric conditions unique to each to understand which primary pollutants spatial variability of the response of PM to basin lead to different optimal control govern the formation of ammonium nitrate, precursors can be addressed. However, an strategies for each basin. we need to address the oxidation potential of extensive reliable database is needed for the Comment 5: Earthjustice comments the atmosphere and determine which application of a 3–D model. The forthcoming that EPA’s proposal to find that VOCs California Regional PM Air Quality Study pollutants (i.e., NOX or VOCS) are the most ‘‘do not significantly contribute to PM– influential for the formation of oxidants in (CRPAQS) database may provide such an opportunity. 10 levels which exceed the standard’’ the system. may make it extremely difficult to Although Pun and Seigneur raises the While Pun and Seigneur indicates that regulate CAFOs at all under SB 700, need to address the oxidation potential the San Joaquin Valley air basin should which contains provisions requiring the of the atmosphere and determine which District to show that either source 13 Pun, B. and Seigneur, C. ‘‘Sensitivity of pollutants are the most influential, it Particulate Matter Nitrate Formation to Precursor categories of agricultural practices does not conclude that VOC controls are Emissions in the California San Joaquin Valley,’’ ‘‘cause or contribute to violations of an absolutely required in the SJV. The Environ. Sci. Technol., 2001, 35, 2979–2987. ambient air quality standard’’ before

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issuing a permit or BACM/BACT the sulfate mass to PM–10 in hard copy would require vast analysis. concentrations violating the annual amounts of paper. Response: As discussed above, EPA standard is 2.6 to 3.1 µg/m3. Plan at EPA believes that the information has determined that VOCs do not Appendix N, N–11. submitted to support the inventories is significantly contribute to PM–10 levels Comment 2: Earthjustice comments sufficient. The 2003 PM–10 Plan which exceed the standard; however, that the SCAQMD regulates all PM–10 includes many summaries of the the CRPAQS results may change this precursors, including SO . different types of inventories needed for determination. In addition, VOC X the Plan, the compact disk provides the reductions may be necessary for ozone Response: The relative importance of necessary documentation supporting attainment, and the determination with ammonium sulfate in particulate matter how the inventories were derived, and respect to PM–10 does not alter that in the South Coast Air Basin is not supporting studies and memoranda fact. identical to the San Joaquin Valley Air regarding inventories are also included Comment 6: One commenter (D. Basin. The South Coast Air Basin has in the docket for this rulemaking. The Moralez) inquires about whether the measured a maximum 24-hour sulfate State and District are also available to µ 3 14 determination that VOC controls will concentration of 20.6 g/m , help interested parties find any not lead to PM–10 reductions was made substantially greater than the values of supporting data for the inventories. based on stationary controls under the 2.7 to 7.2 µg/m3 recorded for the SJV While EPA notes the difficulty of District’s jurisdiction or whether other (see above). Because the technical evaluating these inventories due to the sources such as pesticides, fertilizers analysis done for the SJV does not immense amount of information and insecticides were included. The indicate that SO2 was a significant involved (see TSD, page 9) and the commenter recommends including contributor to violations of the NAAQS complexity of the airshed, EPA does not these sources in the evaluation. in the SJV, it is not necessary to control believe that the inventories are Response: EPA believes that all of the SOX in the SJV to expeditiously attain incomprehensible and need to be source categories mentioned by the the NAAQS. returned to the State. The summaries commenter were included in the B. Emission Inventory provided in the 2003 PM–10 Plan are District’s evaluation. very comprehensible and the supporting Comment 1: Earthjustice comments documentation on compact disk is 3. SOX that the emissions inventories are available to any interested parties. Comment 1: Earthjustice comments incomprehensible, that specific activity Comment 2: Earthjustice comments that secondary ammonium sulfate can levels, emissions factors and models are that the Plan omits a number of critical be a significant contributor to PM–10 only summarized in the Plan, and that pollution sources from the emissions concentrations in certain locations and the emissions factors are spread through inventory (i.e., cultivation emissions, at certain times of year, yet the Plan numerous studies, memorandums and agricultural and industrial bulk contains no controls on SOX. Pun and documents on a compact disk available materials, poultry emissions, and Seigneur at 3–14 (ammonium sulfate only by request. Earthjustice cites EPA’s windblown dust from orchard and third largest component of PM–2.5 at TSD comment that the inventory ‘‘is a vineyards). Earthjustice comments that Kern). massive collection of data and requires the ammonia inventory is possibly Response: EPA believes that the a great deal of time to review* * *’’ but underestimated due to using estimates contribution of ammonium sulfate to the disagrees with EPA that the (from Census of Agriculture) that may PM–10 24-hour and annual standards is incomprehensibility is a ‘‘minor underestimate the number of poultry small, approximately 3–4% of the total comment.’’ Earthjustice states that the and cows. Earthjustice then comments mass. The Pun and Seigneur paper inventories do not meet minimum data that the emissions inventory lacks indicates that ammonium sulfate was reporting documentation standards in emissions from leaf blowers and general the third largest component of PM–2.5 EPA guidance, and thus should be landscape and maintenance activities at the Kern Wildlife Range: returned to the State for modification. and that these emissions should be included in the Plan and not put off as Although ammonium sulfate only Response: The amount of data used to accounted for 6% (<3.4 µg/m3 at Kern ‘‘further study measures.’’ Wildlife Refuge, <3.7 µg/m3 at Bakersfield) of develop, maintain and update the Earthjustice also comments that there the PM–2.5 measured during IMS 95 in the emissions inventories for the SJV, a were numerous significant changes San Joaquin Valley, it was the third largest large and diverse area, is massive. The made to the inventories which are component at the rural site of Kern Wildlife District and State have provided a unjustified. Earthjustice states that Refuge. detailed discussion of how the drastic reductions in emissions for The relative contribution of inventories are developed and agricultural sources were made during ammonium sulfate to PM–2.5 differs summaries of the inventories in the 2002–2003 based on ‘‘stakeholder from the contribution to PM–10. The 2003 PM–10 Plan.15 The reference suggestions’’ rather than scientific percentage contribution of ammonium documents, R1 and R2, are provided on evidence. Changes noted by Earthjustice sulfate to PM–10 levels in the San a compact disk (CD–ROM) and include include: agricultural land preparation Joaquin Valley is low, especially at the numerous spreadsheets with volumes of emissions decreased by approximately locations exceeding the PM–10 24-hour information. Providing these documents 20,000 tons per year of PM–10; almond and annual standards. The Plan at shaking emissions factor (EF) decreased Appendix N, N39–43 lists the sulfate 14 2003 South Coast Air Quality Management by ten times from 3.7 to 0.37; CARB’s mass determined by Chemical Mass Plan, page 2–21. http://www.aqmd.gov/aqmp/ almond sweeping EF of 13.1 pound PM– AQMD03AQMP.htm. Balance model, based on a chemical 15 See Chapter 3, 2003 PM–10 Plan, Appendix B: 10/acre was rejected and replaced with analysis of the filters on days when the Basin-Wide Summary of District’s On-road Motor a 3.7 EF; calf and heifer populations PM–10 standards were exceeded. The Vehicle Emissions Inventory; Appendix C: Updated were excluded from dairy operation contribution of the sulfate mass to the Emissions Inventory Category Changes; Appendix emissions; and changes were made to D: Seasonal Emissions Inventories; Appendix J: 24-hour standard ranges from 2.7 to 7.2 Attainment Inventories; R1: Detailed Annual the internal combustion engine µ 3 g/m , approximately 3.5 to 4% of the Emissions Inventories (CD–ROM); R2: Detailed emissions, dropping it 275% from 47 total PM–10 mass. The contribution of Seasonal Emissions Inventories (CD–ROM). tpd of NOX to 17 tpd of NOX.

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Earthjustice also notes that EPA was districts create, maintain and use C. BACM Demonstration ‘‘surprised’’ by the ‘‘relatively low emissions inventories. The Web site is: emissions estimates’’ for sand and http://www.arb.ca.gov/emisinv/district/ 1. Commitments for BACM/BACT gravel and the Plan does not make any districtresources.htm. Comment 1: Earthjustice comments commitment to further address this. For categories where Earthjustice is that a large number of significant source Response: As stated in the 2003 PM– claiming that there are missing source categories, in addition to Ag-CMP- 10 Plan: category estimates, the Morrow and regulated sources, are not subject to Emission inventories are never considered Gaffney memo provides additional adopted—or even proposed or to be entirely complete at one given time. discussion of how these emissions will * * * [I]nventories can always be improved identified—control measures. Until the not impact the attainment relevant requirements are adopted—and with the use of better emission factors and demonstration and how additional data activity data. The District, in cooperation no longer subject to change in the rule with ARB, is committed to continually may be obtained on these categories in development process—for each of these updating the emission inventory as research the future. For categories where the source categories, EPA cannot emissions estimates have changed, studies, emission factor updates, and other conclusively determine that the Plan information become available. When generally going down, the Morrow and provides for the implementation of emissions data change dramatically, the Gaffney memo provides additional BACM/BACT for all significant sources District is committed to revising the discussion on what the lower estimates inventory and to ensuring that any impact is were based on and why they were used. of PM–10 and PM–10 precursors. As a reflected in the control strategy and the result, Earthjustice claims that full attainment demonstration. The Morrow and Gaffney memo also addresses comments raised by D. approval of the Plan is improper. Plan at 3–4. Howekamp in a declaration supporting Earthjustice cross-references its EPA concurs with the above statement Earthjustice’s comments. EPA has additional comments on commitments by the District. CAA section 172(c)(3) reviewed the 2003 PM–10 Plan’s which are addressed in section II.H requires a ‘‘comprehensive, accurate, inventory and the Morrow and Gaffney below. and current’’ inventory of actual memo and continues to believe that the Response: Section 189(b)(1)(B) emissions from all sources; however Plan’s inventory was the best available EPA recognizes that inventories are not requires that serious area PM–10 plans inventory at the time of Plan static, but are constantly being updated include ‘‘[p]rovisions to assure that the development and thus satisfies the and renewed as new information, best available control measures for the CAA’s requirement for a techniques and studies are made control of PM–10 shall be implemented comprehensive, accurate, and current available.16 The State and District used no later than 4 years after the date the inventory. EPA expects that the District the best available inventories at the time area is classified (or reclassified) as a and State will include additional of plan development. If a State excludes Serious Area.’’ Nothing in this language inventory revisions in their mid-course any of the emission sources from its either requires a state to have adopted review due in March 2006. emission inventory, it must provide controls in place before a SIP revision documentation on why the source(s) Comment 3: Earthjustice comments can be approved into its PM–10 plan or were excluded (PM–10 Emission that the base year relied upon to forbids the adoption of an enforceable Inventory Requirements, Final Report, determine de minimis levels is commitment to meet the statute’s September 1994, Prepared for: Emission inconsistent and that different BACM 17 requirement. Inventory Branch (MD–14), Sulfur inventories are used in order to exempt Dioxide/Particulate Matter Programs sources. The Plastic and Plastic Consistent with this statutory Branch (MD–15), Office of Air Quality Products Manufacturing source category language, EPA has historically Planning and Standards, U.S. is provided as an example of a category determined that an enforceable Environmental Protection Agency, whose de minimis determination is commitment to adopt and implement Research Triangle Park, NC 27711, page based on a different base year inventory BACM in a SIP meets this statutory 20). CARB has provided additional (2003 PM–10 Plan, Table 4–8). In requirement since it constitutes a information addressing why sources addition, they believe that federally ‘‘provision to assure that BACM is were emitted (April 21, 2004 approved control measures are implemented’’ by a fixed deadline. As a memorandum from Sylvia Morrow and necessary to ensure that de minimis result, the commenters’ complaint that Patrick Gaffney to Kurt Karperos, source categories remain below the de ‘‘[b]y definition the plan fails to Follow-up information on San Joaquin minimis levels. implement BACM/BACT for all source Valley PM10 Plan emission inventory Response: See section II.C.4. below. categories for which no developed issues raised in public comment Comment 4: One commenter (LaSalle) control measures exist’’ has no merit (Morrow and Gaffney memo)) and EPA states that emission estimates by CARB since the statute itself does not impose expects the inventory will be updated as have been proven inaccurate. The such a requirement. Because the statute part of the State and District’s commenter indicates that CARB does not define what is a ‘‘provision to commitment to submit a new plan by estimates of dairy ROG emissions have assure BACM is implemented,’’ EPA March 2006. EPA generally relies on the historically been too high and CARB has may adopt an interpretation reasonably State and local agencies to develop, failed to correct the problem. accommodated to the purpose of the maintain and update their inventories. statutory provision. Chevron U.S.A., Inc. CARB has a Web site with additional Response: As discussed above, the information on how California air emission inventories are continually being improved and updated with new 17 EPA has interpreted the BACM requirement in CAA section 189(b)(1)(B) to include BACT. ‘‘State 16 Once a plan has been adopted, EPA does not data. EPA believes that CARB and the Implementation Plans for Serious Areas, and generally require plan elements such as emissions District used the best available inventories to be revisited and updated in response information at the time of plan Attainment Date Waivers for PM–10 Nonattainment to new information. The U.S. Court of Appeals for Areas Generally; Addendum to General Preamble the District of Columbia Circuit recently addressed development and understand that for the Implementation of Title I of the Clean Air a similar issue and affirmed EPA’s position. Sierra further refinements will be included in Act Amendments of 1990,’’ 59 FR 41998, 42009 Club v. EPA, 356 F.3d 296 (D.C. Cir. 2004). future plan submittals. (August 16, 1994)(Addendum).

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v. Natural Resources Defense Council, regulation. 69 FR 5412, 5420. The agricultural sector because of the 467 U.S. at 842–44.18 District’s 2003 PM–10 Plan commits to variable nature of farming. As a In accepting enforceable adopt and implement a program that technical matter, neither we nor the commitments to meet the requirements will achieve BACM level controls by a State is in a position to dictate what of section 189(b)(1)(B), however, EPA specific schedule and 33.8 tons of precise control method is appropriate has required states to undertake an emissions reductions. The 2003 PM–10 for a given farm activity at a given time analysis to ensure that the regulation Plan also states that: in a given locale. The decision as to ultimately adopted pursuant to the [p]articipation in the Ag CMP program will which control method from an array of commitment will represent a BACM be mandatory, but the growers will, by their methods is appropriate is best left to the level of control. As we describe in our own choosing, select measures most individual farmer. Moreover, the proposed rule, a state must determine appropriate for their operation. The source economic circumstances of farmers vary the technical and economic feasibility of categories include (1) unpaved roads, (2) considerably. As a result, it is potential control measures for each of unpaved vehicle/equipment traffic areas, (3) imperative that flexibility be built into the significant source categories. 69 FR land preparation, (4) harvest, and (5) other— any PM–10 control program for the 5412, 5418. Thus the measure that is the including windblown PM10 from open areas, agricultural source category whether subject of a commitment must describe and agricultural burning * * *. Growers that program is required to meet the generally the type and level of control must select at least one management practice RACM or BACM requirements of the from each of the five categories. * * * to be adopted. Act. Id. Moreover, once the ultimate control 2003 PM–10 Plan, page 4–25. Furthermore, a requirement that an measure is adopted and submitted to More than one management practice individual source select one control EPA, the Agency undertakes an may be selected by a grower if it is method from a list, but allowing the additional evaluation to ensure that that technically and economically feasible, source to select which is most measure meets the statute’s BACM but a BACM level of control will vary appropriate for its situation, is a requirements. See, e.g., the Arizona from grower to grower. The plan points common and accepted practice for the rulemakings in which EPA initially out that: control of dust. For example, in our 19 approved as RACM a requirement in [e]missions from agricultural sources vary by PM–10 federal implementation plan a state statute to adopt and implement many factors that are beyond the control of (FIP) for Phoenix, we promulgated a best management practices for the grower. For example, drought conditions RACM rule applicable to, among other agricultural operations and and related cuts in water deliveries can lead things, unpaved parking lots, unpaved subsequently determined that the rules to increased fallow lands and more wind roads and vacant lots. The rule allows adopted pursuant to the statute blown dust emissions. Market conditions can owners and operators to choose one of represented RACM/BACM. 64 FR 34726 change quickly and can turn a profitable crop several listed control methods (pave, (June 29, 1999); 66 FR 51869 (October into a losing proposition. This limits the apply chemical stabilizers or apply ability of growers to absorb the costs of 11, 2001); 67 FR 48718 (July 25, 2002). 20 controls in many cases. gravel). 40 CFR 52.128(d). In programs 2. Agricultural Conservation allowing a choice of compliance Id. methods, it is clearly not feasible to Management Practices (Ag CMP) The regulatory approach selected by Program require a regulated source to provide a the District is similar to those adopted reasoned justification for choosing one Comment 1: Earthjustice comments by the SCAQMD for the South Coast Air option over another. that the Ag CMP program exists only in Basin and by the Arizona Department of As with the South Coast and Phoenix conceptual form, accounts for a large Environmental Quality for the Phoenix programs, EPA believes that the 2003 portion of fugitive dust emissions in the (Maricopa County) PM–10 PM–10 Plan’s commitment described SJV and fails to provide for BACM-level nonattainment area. See, e.g., discussion above, in our proposed rule and in the controls for several reasons. of the South Coast and Phoenix 2003 PM–10 Plan provides the First, Earthjustice comments that the approaches at 66 FR 50252, 50268– flexibility necessary to allow for the Ag CMP program requires growers to 50271 (October 2, 2001) and 67 FR variability in farming while still select only one CMP per category (e.g., 48730 (July 25, 2002). As we have achieving a BACM level of control. categories include unpaved roads, land pointed out in the context of the Indeed, flexibility is more important in preparation, harvest, etc.) which Phoenix program, farming operations the SJV because of the far greater violates the RACM and BACM are inherently complex and highly diversity and number of crops, acreage standards. Earthjustice argues that the variable and therefore PM–10 controls and soils. For example, in 1997, there RACM process requires adoption of all need to be tailored to individual were over 9 million acres farmed in the RACM and a reasoned justification must circumstances. Moreover, there is a SJV as compared to approximately be provided for any rejected measures. limited amount of scientific information 700,000 acres in Maricopa County.21 Allowing growers to select only one concerning the emission reduction CMP per category would allow growers potential and cost effectiveness of the 20 See also SCAQMD Rule 403 (providing for to avoid adopting all RACM. available and known control measures alternative compliance mechanisms for the control Response: As discussed in our for agricultural operations. Therefore, of fugitive dust from earthmoving, disturbed surface areas, unpaved roads etc.). We approved this rule proposed rule, the District has chosen to EPA has previously concluded that, on December 9, 1998 (63 FR 67784). See also our reduce emissions from agricultural given this rudimentary state of approval of Maricopa County Environmental sources with a program, i.e., the Ag CMP knowledge, requiring more than one Services Department (MCESD) Rule 310 and Rule program, that provides more flexibility control measure cannot be technically 310.01 as meeting the RACM/BACM requirements of the CAA (67 FR 48718, July 25, 2002) and EPA’s than a typical command and control justified and could cause an proposed approval of Sections 90 through 94 of the unnecessary burden on farmers. 66 FR fugitive dust regulations for Clark County as 18 EPA’s approach here does not represent any 50268, 50269. meeting those requirements (68 FR 2954, January departure from prior Agency actions approving We have also previously found that 22, 2003). SIPs. See section II.H. 21 1997 Census of Agriculture, California 19 CAA section 189(a)(1)(C) contains the same allowing sources the discretion to Agricultural Statistics Service and Arizona language as section 189(b)(1)(B) with respect to the choose from a range of specified options Agricultural Statistics Service, U.S. Department of implementation of RACM. is particularly important for the Agriculture (USDA).

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Moreover, in 2002, there were 350 crops from RACM to the generally more analogous small quantity exemption. grown in California, 77 of which were stringent BACM does not occur. The SJV See, for example, 40 CFR 60.32b(a), 40 found in large-scale commercial is not unique in this respect. In the CFR 63.100(b)(4); District Rule 4305.2.1. operations, and there were significant Phoenix area we approved State Comment 5: Earthjustice comments livestock and poultry operations. Six of legislation and, subsequently, a general that the Ag CMP program does not the 10 agricultural counties in California permit rule, for the agricultural sector as require BACM for agricultural are in the SJV.22 In contrast, in Maricopa meeting both RACM and BACM windblown dust. Windblown dust is County in 2002, five crops (cotton, requirements. See discussion at 66 FR one of the most significant contributors wheat, corn, alfalfa and hay) comprised 50252, 50254–50255. to PM–10 in the SJV. Under the CMP 83.6% of the acres farmed.23 Comment 3: Earthjustice comments program, windblown dust requirements EPA also believes that the SJV Ag that since there is no emission reduction are combined with other categories such CMP approach is consistent with CAA target there is nothing to prevent as agricultural burning which is already section 172(c)(1) requiring the operators from selecting only the least subject to existing District rules and implementation of all RACM. EPA has effective measure in a category when Senate Bill 705. Nothing prevents an long provided for certain limitations on other more effective and feasible operator from satisfying the CMP that requirement. For example, EPA has measures may be available. At a program by only complying with the not required the implementation of minimum, operators should be required agricultural burning requirements. measures that would not advance to implement the most effective measure Further, there is no evaluation of the attainment or measures for source from each category to meet BACM Coachella Valley windblown dust categories that are de minimis. See 57 standards. measures. FR 13498, 13540, 13560 (April 16, Response: As stated previously, the Response: The District’s 1992). These limitations have been 2003 PM–10 Plan commits to achieve a meteorological analysis of wind speeds upheld by the courts. See, e.g., Ober v. BACM level of control by reducing PM– associated with PM–10 exceedances Whitman, 243 F.3d 1190 (9th Cir. 2001) 10 emissions for the overall agricultural found that the exceedances largely and Sierra Club v. EPA, 294 F.3d 155 category by 33.8 tons per year by 2010. occurred during periods of low winds (D.C. Cir. 2002). Similarly, and for the 2003 PM–10 Plan, 4–29. For the reasons and stagnant conditions in the fall and reasons discussed above, EPA has discussed in our response to the winter. 2003 PM–10 Plan, ES–10, 5–6; concluded that requiring more than one previous comment, flexibility is needed see also section II.L. below. Thus, measure for the agricultural sector is not in any program controlling agricultural windblown dust is not generally currently reasonably available. sources. The Ag CMP program will considered to be a significant Comment 2: Earthjustice claims that require at least one measure from each contributor to PM–10 exceedances in the Ag CMP program does not meet of the five categories under the program, the SJV and EPA believes that BACM requirements since BACM is thus, where it’s economically and windblown dust measures are therefore more stringent than RACM. technically feasible, more than one not necessary for attaining the PM–10 Response: When a moderate area is measure may be implemented. standards. reclassified to serious, the requirement Comment 4: Earthjustice comments The District recognizes, however, that to implement RACM in section that exemptions found in Draft District there may be specific localized 189(a)(1)(C) remains. Thus, a serious Rule 4550 (i.e., agricultural operations situations that warrant windblown dust area PM–10 plan must also provide for of less than 100 acres from the CMP measures and has included them in the the implementation of RACM as program and animal feeding operations Ag CMP program so that growers will expeditiously as practicable to the of various sizes) are not justified. have the flexibility to use them as extent that the RACM requirement has Exemptions should be based on whether needed (as well as in District Regulation not been satisfied in the area’s moderate there is a de minimis contribution to the VIII). PM–10 problem and no demonstration Comment 6: Earthjustice comments area plan. that Draft Rule 4550 fails to set forth However, we do not normally conduct is made as to whether or not these criteria by which the air pollution a separate evaluation to determine if a smaller sources can not be included. control officer (APCO) will implement serious area plan’s measures also meet Comments also point out that smaller the Ag CMP Program. Draft Rule 4550 the RACM requirements as interpreted exemptions are found in other areas. Response: EPA has been working currently allows the APCO to weaken by us in the General Preamble at 13540. closely with the District during the the Handbook, grant exemptions from This is because in our serious area development of Rule 4550 to ensure that the program, or to increase the number guidance (Addendum at 42010), we the Ag CMP program will achieve a of control categories, all without public interpret the BACM requirement as BACM level of control. That rule, input or a SIP revision. Commenters generally subsuming the RACM however, is not the subject of this believe that the CMP plans should be requirement (i.e. if we determine that rulemaking. We will thoroughly available for public review (to same the measures are indeed the ‘‘best evaluate the rule once it has been degree as CAA Title V or operating available,’’ we have necessarily adopted by the District and submitted to permits are), should contain a concluded that they are ‘‘reasonably us. Earthjustice will of course be able to mechanism to ensure citizens are able to available’’). Therefore, when, as here, a comment on any rulemaking action EPA verify that growers are participating and control measure is being developed to may take on Rule 4550. the CMP plans are being implemented, meet both the RACM and BACM EPA notes, however, that small and that adjustments to rule requirements, a separate analysis to quantity exemptions can be justified on applicability thresholds are subject to determine if the measures represent a an economic basis. Thus, even if sources public review. RACM level of control is not necessary. smaller than 1 acre result in significant Response: See our response to the In such a case, the usual progression emissions, if control costs are too high, previous comment. EPA is working with the BACM requirement may be deemed the District as it develops Rule 4550 to 22 2002 California Department of Food and Agriculture Resource Directory. met with no control. Addendum at ensure that the Ag CMP program will 23 2002 Arizona Agricultural Statistics Service, 42010. Most federally-enforceable achieve a BACM level of control. While USDA. prohibitory rules have some sort of Rule 4550 is not the subject of today’s

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action, we note that the most recent process to develop the specific RACM unregulated. As such, extensive draft limits the discretion of the APCO. that would ultimately be proposed for stakeholder input, among other things, Comment 7: Earthjustice comments adoption and that EPA intended the was absolutely essential. In the SJV, the that the Ag CMP Program must contain RACM to take the form of BMPs. 63 FR development of a mature regulatory actual control measures. The ‘‘Ag CMP 41326 (August 3, 1988). Thus, rather program is necessarily following a List’’ must be included as part of Rule than an adopted regulation, EPA similar path from concept to specific 4550 in order to allow citizens to promulgated a commitment controls. challenge the substantive components of accompanied by a conceptual Comment 8: One commenter (D. the list. Because EPA concedes that the description of the program to meet the Moralez) inquires about the mechanism lists were not available for EPA review CAA’s RACM requirements. for including VOC controls in the Ag for the proposal and without the lists, In 1997, Arizona passed legislation CMP program. Commenter also Earthjustice believes there is no basis for establishing an Agricultural BMP recommends a recordkeeping EPA’s conclusion that the Ag CMP Committee and directing the Committee requirement for pesticides and other program will achieve a BACM level of to adopt by rule by June 10, 2000, an VOC-containing materials applied to control (or even a RACM level). EPA agricultural general permit specifying agricultural crops in the Ag CMP justifies that the Ag CMP program’s BMPs for reducing PM–10 from program. program description and similarity to agricultural activities. The legislation Response: The 2003 PM–10 Plan does other EPA approved programs is enough also required that implementation of the not include VOC reductions from the Ag to satisfy BACM, but Earthjustice agricultural controls begin by June 10, CMP program. The District will be believes this comparison must rely on a 2000 with an education program and developing their ozone plan in coming comparison of actual requirements. full compliance with the rule be months which may address VOC Since there are no adopted measures for achieved by December 31, 2001. See emissions from pesticides. the Ag CMP program, Earthjustice Arizona Revised Statutes (A.R.S.) 49– believes EPA cannot approve the 457. On June 29, 1999, we approved the 3. Ag Crop Processing Losses and Ag program as BACM. Further, Earthjustice legislation as meeting the RACM Products Processing Losses notes that EPA’s approval of Maricopa’s requirements of the CAA and withdrew Comment 1: Earthjustice comments the FIP commitment to adopt and best management practices (BMP) that the Plan fails to implement BACM implement RACM for agricultural fields general permit rule as BACM was based for agricultural crop processing losses and aprons in the Maricopa area. 64 FR on a rule that was adopted and already and agricultural products processing 34726. While more extensive than the approved as RACM. losses. The Plan has identified these as FIP commitment, the legislation Response: EPA believes that the significant source categories. As a result, approved by EPA as meeting BACM is Agency can approve, as meeting the it is not sufficient that the Plan merely less detailed than the Ag CMP Program CAA’s BACM requirement, the states the District’s unenforceable commitment to adopt and implement provisions in the SJV 2003 Plan. While we approved the Arizona intention to update these inventory the Ag CMP Program based on the items. description provided in the 2003 Plan. legislation as RACM, it was the State’s Response: After the close of the As discussed previously in section intent that it also serve as BACM for comment period, we discussed this and II.C.1. above, we believe that section agricultural sources in the serious area other comments with District staff and 189(b)(1)(B) does not require that BACM PM–10 plan. After a series of meetings received copy of a March 30, 2004 be in the form of an adopted rule. during 1999 and 2000, the Agricultural memorandum from George Heinen Moreover, the Plan, pages 4–23 to 4–29, BMP Committee adopted the (SJVUAPCD) to Scott Nester contains a detailed description of the agricultural general permit rule and (SJVUAPCD) regarding, ‘‘EPA questions scope of the program. EPA believes that associated definitions, effective May 12, on 2003 PM10 Attainment the Plan’s commitment to implement a 2000, at Arizona Administrative Code Demonstration Plan’’ (SJVUAPCD’s BACM level of control for agricultural (AAC) R18–2–610, ‘‘Definitions for R18– 3/30/04 memo). As discussed in this sources is sufficient to satisfy the BACM 2–611,’’ and 611, ‘‘Agricultural PM–10 memo, these categories were vestiges of requirement. EPA will continue to work General Permit; Maricopa PM10 past emission inventory practices and with the District as it develops Rule Nonattainment Area’’ (collectively, encompassed field activities (crop 4550 to ensure that the Ag CMP program general permit rule). The general permit processing) and post-harvest activities will achieve a BACM level of control. rule contains the BMPs that regulated (product processing). Implementation of In fact, the history of the control of sources are required to regulate. We BACM for the field activities is agricultural operations in Maricopa approved the general permit rule as addressed by other components of the County, alluded to by the commenter, is meeting the CAA requirement for RACM Plan, including the Conservation instructive. In August 1988, EPA on September 10, 2001 (66 FR 34598) Management Practice program and state promulgated a FIP for the Phoenix PM– and for BACM on July 25, 2002 (67 FR and federal mobile source controls. 10 moderate nonattainment area.24 48718). Implementation of BACM for the post- Among other things, the FIP provided Thus, in the Phoenix area, the harvest activities, which are primarily for the implementation of RACM for development of RACM/BACM controls stationary heat sources, is also agricultural fields and aprons via an took a number of years and evolved from a simple commitment to adopt and addressed by other components of the enforceable commitment to propose and implement RACM to a fully developed Plan, including SJV Rule 4306 (boilers, finalize adoption of RACM for those general permit rule with specific BMPs steam generators and process heaters), sources in September 1999 and April that provides for a BACM level of commitment C (dryers), and 2000, respectively. In the preamble to control. The evolution from a commitment I (small boilers, steam the rule EPA explained that the Agency commitment through an expanded generators and process heaters). 2003 intended to convene a stakeholder conceptual approach to the final rule PM–10 Plan, 4–23. The statement in the 24 The area was subsequently reclassified as a was necessary for a number of reasons, Plan regarding inventory improvements serious PM–10 nonattainment area. 61 FR 21372 chief among them that the agricultural was not intended as a demonstration of (May 10, 1996). sector had traditionally been BACM implementation.

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4. Plastics and Plastic Products BACM requirements for cotton gins by explains that SJVUAPCD Rule 2280 and Manufacturing Sources the 4th quarter of 2004. SJVUAPCD has CARB’s portable equipment registration Comment 1: Earthjustice comments drafted Rule 4204 to regulate cotton program (PERP, see 13 California Code that the Plan fails to implement BACM gins, held workshops on the draft rule, of Regulations 2450–2466) provide for plastics and plastic products and appears on schedule for 4th quarter BACM for this category. These rules manufacturing sources. The Plan does 2004 adoption. The April 6, 2004 draft establish numerous operational not demonstrate that the regulations staff report for Rule 4204 includes requirements and emission limitations adopted in 2000 fulfill BACM nor does analysis of several alternative control for applicable engines. Sources may strategies (e.g., rotary drum filters, choose to register engines, including the Plan justify that it is appropriate to mechanical conveyors and plenum those used for oil drilling and workover, use an inventory for a different year in chambers) which further supports the under either PERP or SJVUAPCD’s evaluating emissions from this category conclusion that 1D–3D cyclones analogous Rule 2280 program. Most as de minimis. Furthermore, the Plan generally fulfill BACM for this source sources register under PERP because it does not demonstrate that emissions category. is less expensive and allows use of from this source category will be de portable engines throughout the state. minimis in future years, when emissions 6. Manufacturing and Industrial Fuel We believe that PERP does on balance are projected to increase. Combustion Sources provide more stringent requirements Response: SJVUAPCD’s 3/30/04 Comment 1: Earthjustice comments than Ventura County Rule 74.16 for memo explains that after the Plan was that the Plan fails to implement BACM engines used in oil drilling and developed, the District determined that for manufacturing and industrial fuel workover. While Ventura County Rule emissions had been overestimated for combustion sources. The Plan merely 74.16.B.1 requires electrification of this source category. It appears that the describes generalized control concepts drilling operations, most sources have 1.5 tons per day (tpd) emission estimate that could be developed, and does not been exempted from this requirement was based on obsolete inventory even clearly commit to specific under section C of the rule and few, if methods preceding consolidation of the requirements. No basis is provided for any, new wells have electrified as a eight county air pollution control EPA’s conclusion that controls to be result of this requirement (per telephone districts into the SJVUAPCD. developed for industrial water heaters conversation between Karl Krause, SJVUAPCD’s current emissions will generally establish 30 ppm NOX Ventura County APCD, and Andrew estimate, based on information for each limits similar to SCAQMD Rules 1146.1 Steckel). As a result, most sources of the specific sources within the and 1146.2. subject to Ventura County Rule 74.16 category, is 0.07 tpd of PM–10. We Response: We agree that the must comply with the State (adopted believe that this information is derived descriptions of these control measures January 27, 2000 http://www.arb.ca.gov/ from a more accurate methodology than on pages 4–31, 4–43 and 4–44 of the regact/ciengine/ciengine.htm) and the 1.5 tpd estimate and is well below Plan do not explicitly commit to national (40 CFR 89.112) Tier 1 NOX the de minimis level of .9 tpd for PM– specific requirements for manufacturing standard for off-road compression 10. 2003 PM–10 Plan, pages 4–14 to 4– and industrial fuel combustion sources. ignition engines. By comparison, the 15. However, the language on pages 4–22, PERP program has required most 5. Cotton Gins 4–23, 4–30, 4–31 and 4–42 to 4–44 engines to comply with Tier 1 or more clearly and explicitly commits to 2.2 tpd stringent Tier 2 standards. In addition, Comment 1: Earthjustice comments of NOX emission reductions from this Ventura County Rule 74.16 applies only that the Plan fails to implement BACM category. SJVUAPCD’s 3/30/04 memo to new well drilling, while PERP applies for cotton gins. The Plan merely explains that the 2.2 tpd commitment to both new wells and well workover. describes various measures that could was based on an assumption that a 30 We note that comparison to SJVUAPCD be adopted to implement BACM, and ppmv standard would be applied to Rule 4701 limits is not necessary does not even clearly commit to specific these sources. This memo notes that, ‘‘as because Rule 4701 was not designed to requirements. part of the Plan development effort, the control engines used for oil drilling and Response: We agree that the District examined similar, existing workover. description of this control measure on standards and found the 30 ppmv limits 8. Residential Water Heaters page 4–30 of the Plan does not explicitly in SCAQMD Rules 1146.1 and 1146.2 to commit to specific requirements for be the most stringent rules, at that Comment 1: Earthjustice comments cotton gins. However, language on pages time.’’ SCAQMD staff reports for these that the Plan fails to implement BACM 4–22, 4–23 and 4–30 clearly and actions include analysis of several for residential water heaters. The Plan explicitly commits to 1.5 tpd of NOX control measures and estimates cost does not demonstrate that Rule 4902’s emission reductions from this category. effectiveness of Rule 1146.2 40 nanogram/joule limit fulfills BACM SJVUACPD’s 3/30/04 memo explains requirements as high as $8,400/ton for in light of the 10 nanogram/joule limit that the 1.5 tpd commitment was based retrofitting some units. in SCAQMD Rule 1121. on an assumption that high efficiency Response: SJVUAPCD’s 3/30/04 1D–3D and 2D–2D cyclones would be 7. Oil Drilling and Workover memo explains that there is significant required of existing sources. EPA’s TSD Comment 1: Earthjustice comments concern that Rule 1121’s technology- noted that 1D–3D cyclones are that the Plan fails to implement BACM forcing limit of 10 nanogram/joule may considered BACT when issuing permits for oil drilling and workover sources. not be adequately available by the for new and modified sources in the The Plan fails to evaluate lower compliance deadlines. The memo notes SJV. BACT determinations associated emission limits such as those that SCAQMD has received with permits for new and modified promulgated in Ventura County Rule approximately $1 million in mitigation sources are generally at least as stringent 74.16 and SJVUAPCD 4701 and the fees from manufacturers to date for as BACM for existing sources because it State has not submitted a revised failing to meet Rule 1121’s currently is generally more cost effective to version of SJVUAPCD Rule 2280. applicable 20 nanogram/joule limit, control new sources than existing Response: The TSD associated with suggesting that this limit is also not yet sources. The Plan committed to adopt our proposed approval of the Plan adequately available. In addition, all

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manufacturers have requested a delay in SJVUAPCD’s 3/21/02 staff report for requirement allowing growers to submit implementing Rule 1121’s future Rule 4692. plans to the Natural Resources effective 10 nanogram/joule limit. As Conservation Service (NRCS) instead of 10. Regulation VIII Fugitive Dust discussed in the TSD for EPA’s to the SJVUAPCD is not justified. The Sources proposed approval of the Plan, when NRCS’ role should be limited to Rule 1121’s more stringent limits are Comment 1: Earthjustice states that providing technical information rather demonstrated to be adequately the ‘‘Fugitive PM–10 Management Plan’’ than evaluating compliance alternatives. available, they may become a basis for (FPMP) compliance alternative in Rules Response: Although FPMPs do not future BACM determinations. 8061, 8071 and 8081 does not appear to need to be submitted to the District for have a basis for its inclusion and no approval, the District is responsible for 9. Charbroiling other district has such a provision. The developing guidance and criteria by Comment 1: Earthjustice comments commenter compares Rule 8081’s 20% which NRCS (specifically, local that the Plan fails to implement BACM opacity limits, stabilized unpaved road resource conservation districts or the for charbroiling sources. Neither the requirements, and concrete compliance Fresno Regional Office) would use to Plan nor EPA has provided a options (e.g., watering) to the FPMP evaluate the FPMPs in order to verify demonstration that SJVUAPCD Rule compliance alternative’s minimum their consistency with the District’s 4692 or SCAQMD Rule 1138 fulfills control efficiency requirement of 50% guidance. Therefore, the NRCS’ role is BACM. and its lack of a clear mandate to limited to reviewing the FPMPs for comply with 20% opacity. On this basis, Response: In developing Rule 4692, consistency with the District’s guidance, the commenter states that the FPMP Commercial Charbroiling, SJVUAPCD rather than evaluating compliance compliance alternative does not add any investigated the scope of the source alternatives absent criteria. clear benefit to the rule and, in fact, Furthermore, all verified FPMPs are to category, currently available control could weaken it. be made available to the District and the technologies, emission reduction Response: The FPMP’s requirement public. For these reasons, in addition to potential and cost-effectiveness of that 50% control efficiency be achieved the requirement for FPMPs to various options.25 SJVUAPCD is equivalent to the minimum control demonstrate 50% control efficiency, we determined that flameless catalytic efficiency expected from compliance believe the FPMP administrative oxidizers can reduce PM–10 emissions with Rule 8081’s surface stabilization requirements are sufficient to ensure by 83% and VOC emissions by 86%, 26 requirement which otherwise applies. enforceable controls. with an overall cost-effectiveness of We agree that the FPMP alternative does Comment 3: Earthjustice states that approximately $3,000 per ton of not contain an explicit requirement for Maricopa’s Dust Control Plan reduced emissions. Fiber-bed filters, sources to comply with 20% opacity. requirements (as contained in Maricopa thermal incinerators, and activated However, it is unclear whether County Rules 310 and 303) provide a carbon adsorbers were among the other compliance with 20% opacity would more appropriate model for an control technologies considered. necessarily increase control efficiency acceptable FPMP. SJVUAPCD acknowledged that some for unpaved roads or parking areas Response: Maricopa’s Dust Control technologies (e.g., thermal incineration) above the minimum 50% control Plan requirements are specific to may result in higher control efficiencies, mandated. Also, while the FPMP construction sites, which have multiple but SJVUAPCD believes these alternative does not specify control sources of fugitive dust. The FPMP technologies are not practical to require measure options from which applicants provisions of Rules 8061, 8071 and 8081 for every source because of the overall can choose, all FPMPs must include the only apply to unpaved roads and expense and cost effectiveness. control measure to be applied (see Rules unpaved vehicle/equipment traffic SJVUAPCD estimates that 8011 and 8081, section 7.5.4.) along areas. Therefore, we do not believe it is implementation of Rule 4692 will with specific information as to the necessary for the FPMPs to be modeled reduce PM–10 emissions by 0.11 ton/ method, frequency and intensity of the after the extensive dust control plan day. Based on the requirements application. Therefore, the FPMP requirements adopted in Maricopa contained in Rule 4692 and the detailed alternative offers the same minimum County for construction sites. analyses provided in the associated staff control efficiency (50%) and a defined Comment 4: Earthjustice states that report, we believe SJVUAPCD has method of control as would otherwise the Plan retains a threshold of 500– adequately demonstrated be achieved by compliance absent a 3,000 average daily trips to trigger the implementation of BACM for FPMP. requirement to pave shoulders in Rule commercial charbroilers. Potential benefits of FPMPs include: 8061. It is unclear what a threshold with The TSD associated with our owners/operators expressly planning in a range means in practice. In order to proposed approval of the Plan further advance where and when vehicle trip meet BACM, the Plan should either notes that SJVUAPCD used SCAQMD thresholds in the rule will be exceeded establish the threshold as 500 average Rule 1138 as guidance in developing and the details of dust suppressant daily trips or justify any higher SJVUAPCD Rule 4692 for this category. application or other treatment; an threshold. The TSD associated with our proposed emphasis on preventative control as Response: The format of the 500– approval of the Plan further notes that opposed to remedial control in response 3,000 average annual daily trip (AADT) SJVUAPCD used SCAQMD Rule 1138 as to a 20% opacity exceedance, and; a threshold for existing paved roads in guidance in developing SJVUAPCD Rule potential mechanism for targeted Rule 8061 does not adversely impact the 4692 for this category. SCAQMD Rule inspections by the District. rule’s clarity. In practice, cities and 1138 is considered the most effective Comment 2: Earthjustice states that counties responsible for modifying district regulatory standard in effect for the Rule 8081 FPMP administrative existing paved roads determine the this source category and SJVUAPCD AADT of the road. If the AADT is Rule 4692 is nearly identical. See 26 ‘‘Technical Support Document for Maricopa between 500 and 3,000, Rule 8061 County Nonattainment Area PM–10 FIP: Revision to the Phoenix FIP final rule for Unpaved Parking requires a 4-foot shoulder to be 25 Final Staff Report for SJVUAPCD Rule 4692, Lots, Unpaved Roads and Vacant Lots,’’ January 19, established, and if the AADT is above March 21, 2002. 1999, page 3. 3,000, Rule 8061 requires a 8-foot

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shoulder to be established. For purposes limit provides little to no benefit when needed for VOC, ammonia and SOX of meeting BACM, the rule clearly a fugitive dust source is located well based on the NOX/PM strategy. They establishes 500 AADT as the baseline within the property line. Alternatively, question the defensibility of the NOX/ threshold above which paved road if a source is located immediately PM strategy and even if it is the most shoulder requirements apply. Thus, we adjacent to the property line (e.g., an expeditious strategy for attaining the do not agree with the commenter that unpaved road), it may be technically PM–10 standards, Earthjustice believes the requirement is unclear or infeasible to comply with a property the District still retains the obligation to insufficient to meet BACM. line limit which would essentially evaluate and include BACM/BACT for Comment 5: Earthjustice states that require that no dust be emitted. The significant sources of VOC, ammonia although the Plan commits to remove applicable standard in Regulation VIII and SOX as BACM are to be established the exemption for ‘‘implements of for visible fugitive dust is 20% opacity. generally independent of the attainment husbandry’’ from vehicle daily trip Comparing the relative stringency of a needs of an area. counts in Rule 8081, the 75 vehicle property line limit to an opacity In addition, Earthjustice points out daily trip threshold should be lowered standard is technically difficult due to that livestock waste is the most to account for higher emissions the variety of meteorological and other significant VOC source under the resulting from multiple wheelsets of factors associated with any scenario. District’s control, that the South Coast implements of husbandry. The rule However, because the 20% opacity Air Quality Management District is credits trips made by implements of standard is determined at the source’s controlling VOCs and ammonia from husbandry the same as trips made by origin, we generally consider it to be the this source and that the SJV’s Ag CMP passenger vehicles and this may more stringent standard given the speed program only covers the PM–10 underestimate emissions from with which visible fugitive dust emissions from this source. Pesticides implements of husbandry. particles disperse into the atmosphere. and fertilizers is also a very significant Response: The District’s BACM Therefore, we are relying on the source of VOCs in the SJV, not currently analysis for Rule 8081 evaluates applicability of the 20% opacity covered by BACM requirements. emissions from both passenger vehicles standard in lieu of a property line limit Finally, Earthjustice points out that and implements of husbandry with for purposes of meeting the BACM EPA has previously provided comments multiple wheelsets, e.g., tractors and requirement. to the District about the lack of BACM implements with 8 wheels, using EPA’s Comment 7: Earthjustice states that for non-de minimis sources of VOCs. In AP–42 emissions factor equation for the Plan unjustifiably lacks a particular, Earthjustice points out that unpaved roads. The District concludes commitment to include a 100-foot dust EPA wrote ‘‘Categories that must be that a tractor operating between 4 and plume limit. SCAQMD Rule 403 analyzed for BACM include coatings 9 miles per hour produces 85–88 includes a 100-foot limit. The and related process solvents; other cleaning and surface coatings; waste percent of the emissions produced by a commenter notes that SJVUAPCD burning and disposal; food and pickup truck traveling 15 miles per defended the importance of a plume 27 agriculture (industrial processes); hour. This analysis supports including distance threshold as a measure ‘‘of nonmetallic minerals (this BACM implements of husbandry in the rule’s value for construction site managers to analysis should consider any processing vehicle trip threshold, but not the judge the need for additional control activity not addressed by Regulation commenter’s assertion that implements application’’ 28 and that ‘‘a combination VIII) and landfill gases.’’ Earthjustice of husbandry generate higher emissions of opacity with plume distance limits also points out that EPA commented than passenger vehicles and that the 75 (e.g., 100 yards) is the best standard to that the steam enhanced oil well vents vehicle trip threshold should be use.’’ 29 Notwithstanding, SJVUAPCD category had not been adequately lowered. eliminated the proposed commitment to Comment 6: Earthjustice states that evaluated for BACM as it did not establish a 100-foot dust limit. the District eliminated a proposed contain provisions found in similar Response: The District raises concerns commitment to require that visible Ventura and South Coast rules. Since as to the technical feasibility of emissions not travel beyond the EPA previously treated these source compliance with a 100-foot limit, given property line on the basis that such categories as needing BACM, the speed with which a moving vehicle disturbances would be ‘‘subject to the Earthjustice believes EPA has no basis or mobile construction equipment can District’s nuisance rule.’’ The on which to conclude that BACM cover a 100-foot area.30 The inclusion of commenter indicates that many counties demonstration are not needed at this a 100-foot limit in SCAQMD Rule 403 in the Valley specifically exempt time. does not mean it is necessary for agriculture from nuisance rules and lack Response: As discussed in section Regulation VIII to meet BACM, as long a mechanism to control dust traveling II.A. above, EPA is concurring with the as other applicable limits combined beyond property lines. The commenter SJV PM–10 Plan’s NOX/PM strategy provide adequate stringency. We believe concludes that no basis exists for until the CRPAQS results become the combined effect of the 20% opacity SJVUAPCD’s elimination of its initial available. Since, consistent with the limit and control measure requirements commitment to control visible NOX/PM strategy, VOC, SOX and in Regulation VIII are sufficient to meet emissions that travel beyond property ammonia reductions are not necessary BACM. lines. for attainment, EPA believes a BACM Response: EPA’s proposed approval of 11. Significant Sources of VOC, demonstration is not necessary at this time for these precursors. 69 FR 5412, Regulation VIII as BACM (69 FR 5420– Ammonia and SOX 5421) absent a property line limitation 5423. If the CRPAQS results indicate Comment 1: Earthjustice disagrees for visible emissions was not based on that reduction of precursors other than that a BACM demonstration is not the District’s statement that sources are NOX play a significant role in reducing PM–10, the District will be required to subject to the District’s nuisance rule. 28 SJVUAPCD response to April 21, 2003 EPA Rather, we believe that a property line comments at No. 118. revise the 2003 PM–10 Plan to include 29 PM–10 Plan at Appendix G, page G–28. BACM for those precursors and any 27 PM–10 Plan at Appendix G, Exhibit C 30 PM–10 Plan at Appendix G, Exhibit C additional reductions needed for ‘‘Supplemental BACM Analysis’’, page 27. ‘‘Supplemental BACM Analysis,’’ page 17. expeditious attainment.

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In an April 23, 2003 letter to the Plan, which consists of approximately PM–10 plan) includes for these District, EPA commented that certain one thousand pages of TCM analyses measures the commitments adopted by VOC source categories needed to be and resolutions adopted by the local the multitude of jurisdictions, as well as evaluated for BACM; however, these and regional governments, committing the entities’ reasoned justifications for preliminary comments were based on an the governments to specific TCMs. not adopting particular measures. For initial review of the District’s Draft PM– Although the Agency’s PM10 BACM example, see the ‘‘Fresno COG 10 Plan dated March 25, 2003.31 In guidance does not provide an extensive Summary of Commitments—2002 response to EPA’s comments, the discussion of TCMs, EPA agrees with Severe Area Ozone Plan,’’ displaying District included an enforceable the commenter that the PM10 BACM the commitments for the Fresno COG commitment to revise the 2003 PM–10 requirement applies to TCMs.33 CAA itself, Fresno County, the 15 cities in the Plan by March 2006 using the CRPAQS section 108(f) lists 16 transportation County, and the 3 transit agencies results which will provide the necessary control measures. In order to ensure that relating to the matrix of candidate technical information to clearly each entity reviewed comprehensively control measures. understand the role VOC, SOX and and consistently these measures, as well Appendix E includes resolutions ammonia play in attaining the PM–10 as subcategories of the measures, the adopted by each entity. For each of the standards in the SJV. Given this San Joaquin Valley agencies broke the hundreds of measures where enforceable commitment and the NOX/ 16 TCMs into a matrix of 126 measures. implementation has already occurred or PM strategy, EPA believes that requiring The agencies then expanded the matrix is programmed to occur, the resolutions BACM/BACT demonstrations for VOC, by adding 14 other possible measures describe the measure fully, identify the SOX and ammonia is not warranted at (labeled 17), 9 ‘‘existing local responsible agency and implementation this time. government control measures’’ (18), and authority, set out the implementation 22 measures recommended for schedule, present the levels of 12. Mobile Sources—Transportation consideration by the public (19), for a personnel and funding for Control Measures (TCMs) grand total of 171 measures. Appendix implementation, specify the Comment 1: Earthjustice states that E to the 2002 Ozone ROP Plan enforcement program (if any is the Plan fails to include a BACM (incorporated by reference in the 2003 required), and describe the monitoring analysis addressing any section 108(f) program. TCMs. The Plan’s only reference to 33 EPA’s General Preamble includes a discussion EPA believes that the explanations for TCMs is its assertion that certain of RACM provisions for TCMs: ‘‘Local not including specific measures are unspecified measures were analyzed by circumstances relevant to the reasonableness of any equally applicable for BACM as for potential control measure involve practical the Regional Transportation Authorities considerations that cannot be made through a RACM, because the justifications reflect for the Valley’s ozone ROP plan, and are national presumption. Various TCM’s must be each entities’ careful considerations and incorporated by reference in the plan. locally coordinated to minimize contradictory conclusions that particular measures However, because the TCMs in the ROP results and maximize mutually supportive simply are infeasible for the area outcomes. Feasibility of TCM implementation can plan were analyzed only for RACM, thus be particularly complicated, and EPA because of technical, practical, or Earthjustice believes that the TCMs are recognizes the importance of assessing candidate economic reasons. See, for example, insufficient to meet BACM TCM’s in the context of each particular area’s City of Ridgecrest table ‘‘Control requirements. The District errs in situation. Finally, with respect to TCM’s or any other control measures, EPA does not believe that Measures Which are Not Feasible for responding to a public comment that a Congress intended the RACM requirement to Implementation’’; City of Coalinga BACM analysis needs to be performed compel the adoption of measures that are absurd, Resolution No. 2892; City of Orange when the District states that EPA’s unenforceable, or impracticable (see 55 FR 38326, Cove, Resolution No. 2002–12, Exhibit Addendum does not require BACM for September 18, 1990). The EPA, therefore, concludes that it is inappropriate to create a presumption that A—Local Government Control Measures TCMs. all of the measures listed in section 108(f) are per That will not be Implemented; County Response: The 2003 PM–10 Plan se reasonably available for all nonattainment areas. of Fresno Resolution #02–128; Kern incorporates the 2002 Ozone ROP Plan All States must, at a minimum, address the section Council of Governments table ‘‘Example analyses and commitments by the 6 108(f) measures. The EPA believes that at least some of the measures will be reasonably available Local Government Measures.’’ The metropolitan planning organizations for implementation in many nonattainment areas. reasoned justifications are based on and 2 transportation planning agencies, Where a section 108(f) measure is reasonably factors that make a measure either representing collectively the 8 counties, available, section 172(c)(1) requires its inapplicable or impractical to the area, implementation.’’ 57 FR 13560 (April 16, 1992). numerous transit agencies, and all of the The TCM RACM discussion concludes with such as density levels, urbanized area cities in the San Joaquin Valley ozone comments on the legislative history of the 1990 configuration, centers of employment, nonattainment area.32 The commitments CAA Amendments and EPA’s 1979 guidance on traffic volume and flow, congestion and feasibility analyses are included in RACM as construed by the Court of Appeals for the levels, measure redundancy, economic Ninth Circuit in Delaney v. EPA, 898 F. 2d 687 Appendix E of the 2002 Ozone ROP (1990). issues relating to implementing agencies In the 8/16/94 supplement to the General or public participation levels, potential 31 Letter from Jack P. Broadbent to David L. Crow, Preamble relating to SIPs for Serious PM–10 areas, for measures to be counter-productive RE: Preliminary Review of the Draft 2003 PM–10 EPA provided the following brief guidance on from an emissions perspective (e.g., Plan, April 21, 2003. BACM for mobile sources: ‘‘It does not currently creation of new one-way streets), 32 ‘‘The resolutions adopted by the respective appear that mobile sources, as distinct from the entities to commit to implement local government surfaces on which they travel, contribute absence of traffic signals, no means of control measures are included in the Regional significantly to the PM–10 air quality problem in a reasonable enforcement, etc. The Transportation Planning Agency Commitments for sufficient number of areas to warrant issuing commenter has not shown that any of Implementation Document, April 2002. The national guidance on best available transportation the analyses and commitments would document is available for public review at the control measures for PM–10 under section 190 of central San Joaquin Valley Unified APCD office the Act. However, in those areas where mobile be different for BACM, and EPA located in Fresno. In accordance with the Air sources do contribute significantly to PM–10 believes that they would not in fact District planning process for the PM–10 Plan, these violations, the State must, at a minimum, address differ. commitments are incorporated by reference into the the transportation control measures listed in section EPA therefore believes that both the PM–10 Plan. The ozone measures will provide 108(f) to determine whether such measures are emission reductions for precursor gases and help to achievable in the area considering energy, analyses performed by the San Joaquin address the secondary particulate problem.’’ PM–10 environmental and economic impacts and other Valley transportation and governmental Plan, Appendix I, page 4. costs.’’ Addendum at 42013. entities and the commitments by the

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entities reflect a conscientious effort to Attainment Plan focus on direct implementation of Statewide idling assess the viability of achieving particulate.’’ See ‘‘Overview of Regional control programs for diesel vehicles. reductions from implementation of each Transportation Planning Agency Process Also before the PM10 Plan was of the section 108(f) measures and other to Identify and Implement Best prepared, the State had already enacted possible candidate measures, and to Available Control Measures in Support the most stringent Statewide idling adopt and expeditiously implement all of the PM–10 Attainment Plan for the control measure in the country, a measures that were determined to be San Joaquin Valley’’ (April 2003 RTPA restriction on idling in the vicinity of available at this time. BACM Submittal), page 5. schools. CARB has now scheduled a EPA believes that these assessments These analyses and the resulting public hearing on July 22–23, 2004, to were conducted in a thorough process measures are included as elements of consider adoption of Statewide idling with full public involvement. The the reentrained dust and street cleaning control regulations for heavy-duty diesel documents were subject to public provisions of the plan (Regulation VIII), vehicles.35 review and comment in 5 public rather than as TCMs. EPA agrees that One of the San Joaquin Valley workshops before adoption by the local this is appropriate, since the only agencies’ primary justifications for governments.34 Before adoption, the significant source of primary particulate rejecting adoption and implementation measures and assessments underwent matter associated with motor vehicles is of local idling restrictions was their an extensive process, which is reentrained dust from paved and determination that local police summarized in Appendix I of the 2003 unpaved roads, and the specific control enforcement programs needed for non- PM–10 Plan in a document labeled measures to reduce those emissions technology based restrictions on idling ‘‘Overview of Regional Transportation (paving unpaved roads, stabilizing were simply infeasible. For the same Planning Agency Process to Identify and access points onto paved roads, curbing, reason, the proposed State program Implement Best Available Control sweeping, erosion clean-up, etc.) are not emphasizes required installation of Measures in Support of the PM–10 categorized as TCMs. See the definition tamper resistant, automatic idling Attainment Plan for the San Joaquin of TCMs at 40 CFR 93.101: control equipment, as opposed to an Valley’’ (April 2003 RTPA BACM ‘‘Transportation control measure (TCM) idling prohibition enforceable against Submittal). This document sets out an 8- is any measure that is specifically vehicle operators. Like the commenter, step process for biweekly/monthly identified and committed to in the CARB concluded that voluntary meetings to review candidate measures, applicable implementation plan that is programs would be ineffective, based on obtain input and feedback, share either one of the types listed in section evaluations of the State’s limited information, and document in a 108 of the CAA, or any other measure success using educational programs. consistent fashion conclusions on for the purpose of reducing emissions or Unlike the commenter, CARB economic and technological feasibility concentrations of air pollutants from determined that idling restrictions on and program selection and transportation sources by reducing gasoline-fueled vehicles and engines implementation. This 8-step process vehicle use or changing traffic flow or should not be pursued because the hot was followed as the plans were being congestion conditions.’’ Measures to and cold start emissions associated with prepared, and the agencies are reduce primary particulate matter gasoline engines could cancel out or continuing the process to reassess the emissions through reductions in even exceed the benefits from reduced viability of additional controls as ‘‘vehicle use or changing traffic flow or idling. San Joaquin Valley entities congestion conditions’’ are already circumstances change in the future. reached the same conclusion.36 Finally, Again, the public is invited to addressed in Appendix E to the 2003 participate in the process and the results Ozone ROP Plan, since these categories 35 The CARB public notice of the proposed of the process are readily available to of measures relate to the ozone regulatory program provides the following summary the public on a continuing basis. precursors NOX and VOC. of the intended regulation: ‘‘The ARB staff is Finally, it should also be noted that Comment 2: Earthjustice states that proposing a regulation to reduce idling emissions the transportation agencies may have from new 2007 and later model year on-road heavy- the San Joaquin Valley regional duty diesel vehicles (HDDV) with gross vehicle transportation planning agencies proposed a measure to limit vehicle weight rating greater than 14,000 lbs. The proposal reviewed the adopted measures and the idling for the ozone ROP plan, but the requires HDDVs to be equipped with an idle candidate measure analyses in the 2002 plan appears to be voluntary and clearly shutdown system that will shut down the engine fails to meet BACM. The Plan must after 5 minutes of continuous operation at idle. The Ozone ROP Plan and concluded that proposal allows the use of alternative idle reduction they constitute BACM for TCMs and for evaluate implementation of enforceable devices/strategies in order to provide heating and other types of measures under their idling control measures covering all air conditioning for cab comfort, engine oil heating jurisdiction with respect to control of vehicles and equipment throughout the for easy engine start-up in cold ambient conditions, and electric power to charge batteries and for on- secondary particulate matter, such as Valley. Response: Many of the SJV board accessories. Such devices include, but are not NOX. The agencies further agreed that limited to, an automatic stop-start system, on-board they needed also to address additional jurisdictions, as part of their TCM auxiliary devices such as fuel-fired heaters and BACM controls for direct particulate assessment, considered and rejected auxiliary power units, and power inverter/chargers for use with batteries and grid supplied electricity. matter to supplement PM BACM. ‘‘A mandatory idling controls at the local level as infeasible, because of The use of these devices, in lieu of operating the key requirement for the PM–10 heavy-duty engine at idle, will result in significant enforceability, safety, and public health Attainment Plan is the implementation NOX reductions. Reductions in ROG, carbon of Best Available Control Measures issues. Moreover, idling controls were monoxide and carbon dioxide are also expected, but to a lesser extent depending on the type of (BACM). Since the ozone measures also being developed on a Statewide basis in ways that would surmount the alternative idle reduction device/strategy used.’’ described in the previous section will be More details on the proposed regulation, including used to address the secondary feasibility concerns associated with a the rule language, appear at: http://www.arb.ca.gov/ particulate problem, the control local program. Before the PM10 Plan regact/hdvidle/hdvidle.htm. 36 measures being pursued for the PM–10 was prepared, CARB had already See, for example, the reasoned justification adopted the State’s Diesel Risk adopted by the City of Clovis in Appendix E of the 2003 Ozone ROP Plan for not adopting an idling 34 The San Joaquin Valley regional transportation Reduction Program (October 2000), and restriction: ‘‘This measure is infeasible for the City planning agencies developed a Web site to provide as part of that plan had scheduled of Clovis Police Department to implement at this the public with information on the BACM process. expeditious adoption and Continued

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CARB decided to exclude from idling could achieve significant reductions an extension of a PM–10 nonattainment restrictions all commercial and school immediately with the introduction of deadline for the first time beyond 2006 buses to avoid jeopardizing public low sulfur diesel, which would enable [sic]. Because the subpart 1 provision health, in view of the need for new control technologies. EPA cites applies to nonattainment continuous passenger cooling and Response: SCAQMD’s rule prohibits areas in general as opposed to the PM– heating. producing or supplying greater than 15 10-specific subpart 4, EPA is not EPA agrees with the State’s reasoning ppm sulfur fuel on and after January 1, permitted to extend the attainment and conclusions regarding the best 2005, but that date would be extended deadline for up to 10 years. If EPA’s approach and appropriate targets for to match a later compliance date interpretation were correct, EPA would idling restrictions. Thus, EPA supports adopted by CARB, if no later than June be permitted to endlessly extend both the San Joaquin Valley agencies’ 1, 2006. Rule 431.2(c)(4). CARB has attainment deadlines for up to 10 year reasoned justifications for not pursuing workshopped amendments to the State’s periods after each finding of local idling controls and CARB’s diesel fuel regulations and issued the nonattainment. Clearly Congress rationale for expeditiously developing, 15-day notice for the rule amendments, intended for all serious PM–10 adopting, and implementing the based on the CARB Board’s nonattainment areas to attain by proposed Statewide heavy-duty diesel authorization to proceed with the rule December 31, 2006 at the very latest. If vehicle idling control program. adoption, which is currently scheduled Congress ‘‘has directly spoken to the 13. Mobile Sources—South Coast Fleet for July 24, 2004. On that date, CARB precise question at issue’’ and ‘‘the and Low Sulfur Diesel Rules expects to amend the State’s diesel intent of Congress is clear, that is the regulations not only to prohibit sale/ end of the matter.’’ Chevron at 842–843. Comment 1: Earthjustice claims that supply of greater than 15 ppm sulfur It is a general principle of statutory while the Plan includes a generalized fuel on and after June 1, 2006, for construction that where a statute commitment to control emissions from mobile sources and stationary sources, addresses an issue specifically in one publicly-owned fleets, Regulation IX is but also to regulate fuel lubricity levels. section and more generally in another, merely in the ‘‘initial stages of Moreover, EPA’s national 15 ppm sulfur the more specific provision applies. development.’’ The Plan fails to rule goes into effect June 1, 2006 for Response: EPA’s conclusion regarding incorporate or even evaluate the motor vehicles, and EPA has indicated the attainment deadline applicable to SCAQMD’s fleet rules. its intention to finalize in the near the SJV appropriately reconciles the Response: Following adoption of the future national low sulfur fuel provisions of sections 188(c)(2) and (e) SCAQMD’s fleet rules, the Engine restrictions for nonroad vehicles and and 189(d). EPA agrees that, in the first Manufacturers Association (EMA), engines as part of the Tier 4 nonroad instance, i.e., upon classification or joined by other parties, filed suit against standards, which were proposed on May reclassification to serious, the the SCAQMD arguing, among other attainment deadline for such an area can things, that such rules were preempted 23, 2003 (68 FR 28328). Finally, it is not clear that local agencies (as opposed to be no later than December 31, 2001 under section 209(a) of the Clean Air unless extended in accordance with the Act. Although the SCAQMD prevailed the State) have authority to adopt and enforce provisions relating to motor conditions in section 188(e) to no later before the U.S. District Court and U.S. than December 31, 2006. When section Court of Appeals for the Ninth Circuit, vehicle fuel specifications. For these reasons, EPA does not agree that 188(c)(2) and (e) is read in conjunction EMA appealed to the U.S. Supreme with section 189(d), however, it is clear Court. EMA v. SCAQMD, Supreme Court adoption by SJVUAPCD of a rule comparable to SCAQMD’s rule 431.2 is that, after EPA has made a finding of Case Number 02–1343. On April 28, failure to attain for a serious area, the 2004, the U.S. Supreme Court ruled that appropriate or required as BACM at this time. provisions of section 189(d) apply to the at least certain aspects of the SCAQMD subsequently required serious area fleet rules appear to be preempted by D. Attainment Demonstration plan.37 This is apparent from the plain CAA section 209, and remanded the 1. Attainment Deadline language of section 189(d): ‘‘In the case case. Based on this decision and of a Serious PM–10 nonattainment area pending final resolution of other issues Comment 1: Earthjustice states that, in which the PM–10 standard is not of authority not addressed by the under section 188(c)(2) and (e), serious attained by the applicable attainment decision, EPA does not consider local PM–10 nonattainment areas such as the date, the State * * * shall * * *submit air district adoption of rules similar to SJV may be granted at most one within 12 months after the applicable the SCAQMD’s fleet rules to be extension of their December 31, 2001 attainment date, plan revisions which authorized or required. attainment deadlines of no more than 5 provide for attainment of the PM–10 air Comment 2: Earthjustice comments years, i.e., to no later than December 31, quality standard * * *.’’ Emphasis that the Plan should incorporate a rule 2006. Instead, in the proposed rule, EPA added. Section 189(d) clearly governs a akin to SCAQMD’s rule 431.2 (low states that ‘‘because the SJV missed the situation in which a serious area has sulfur diesel). Although EPA will 2001 attainment date otherwise failed to meet its original attainment require all on-road vehicles to use low applicable, we believe that the date of 2001 under section 188(c)(2) (or sulfur fuel by mid-2006 and California attainment date is governed by other up to 2006 under section 188(e)) and has proposed to adopt rules applying to provisions of the CAA.’’ 69 FR at 5424. therefore must submit a new plan that off-road vehicles in 2006, the District This is not a reasonable basis for failing demonstrates attainment some date that to apply section 188(e) given the fact is beyond the earlier established time because traffic stall or congestion is almost that EPA approved deadline extensions deadline. Thus, the attainment plan to exclusively limited to short term signal light cycling. It would be impracticable and unadvisable for other serious nonattainment areas, be submitted within 12 months of the to turn off engines during this time. Furthermore, such as Clark County, Coachella Valley, based on the type of short-term traffic delays noted Maricopa County, the South Coast and 37 In the case of the serious nonattainment areas above, the City does not feel this measure would Phoenix, after they missed the 2001 date other than the SJV cited by the commenters, EPA * * * reduce emissions. Rather this measure would had not made findings of failure to attain the increase emissions due to the stop and start of and still applied section 188(e). serious area deadline. In such cases, section engines, as well as be an issue to public health and Earthjustice further states that EPA 188(c)(2) and (e) continues to govern the applicable safety.’’ cites CAA section 179(d)(3) to support attainment deadline.

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applicable attainment date which has 2. Attainment Demonstration as expeditious as practicable. See, been missed cannot be subject to the Overestimates Emission Reductions respectively, section II. E. and C.2. same attainment deadline as the E. Five Percent Demonstration previous plan. Comment 1: Earthjustice believes that Because, however, section 189(d) the emissions reductions from certain Comment 1: Earthjustice and CRPE merely requires the new plan to control measures are drastically comment that the Plan fails to ‘‘provide for attainment,’’ EPA looked overstated. In particular, they point out demonstrate ‘‘* * * an annual elsewhere in the statute to determine that many of the proposed practices reduction of PM–10 or PM–10 the outer bounds of that deadline. The listed in the Ag CMP are commonly precursors of not less than five percent only other provision of the statute that acknowledged to be in widespread * * *’’ (emphasis added) as required by addresses planning requirements practice already, but whose reductions CAA section 189(d). The commenters applicable to a PM–10 nonattainment have not been included in the emission assert that the statute is clear in area for which EPA has made a finding inventory. Earthjustice argues that if this requiring PM–10 or PM–10 precursor of nonattainment is section 179(d). is the case, then the plan’s inventory is emissions to be reduced by at least 5% Thus, the Agency did not ignore subpart overstated and future reductions from in each year. The commenters also point 4 in favor of subpart 1, but rather the Ag CMP program to meet attainment to legislative history which they assert applied subpart 4 to its maximum extent and the 5% requirement will not be precludes any interpretation of the before turning to subpart 1 to determine achieved because they are already in the statute that would allow less than 5% the applicable attainment deadline for baseline. In addition, Earthjustice points reduction of PM–10 or PM–10 the SJV under the prevailing out that many of the emission factors precursors in each and every year until circumstances. have been lowered and the inventory attainment. Finally, the commenters Under section 179(d)(3), the may not reflect existing practices, thus, note that the SJV is the first area subject attainment deadline applicable to an overstating future reduction estimates. to the requirements of section 189(d), area that misses the serious area Either way, Earthjustice believes that making this an important question of attainment date is as soon as since many growers are already first impression. practicable, but no later than 5 years implementing the CMP, the current Response: EPA agrees that this is a from the publication date of the inventory and reductions for the question of first impression and that the nonattainment finding. EPA may, attainment demonstration are not application of section 189(d) to the SJV however, extend the attainment accurately portrayed. is an important aspect of this action. deadline to the extent it deems Response: The inventory and Because EPA has not previously applied appropriate for a period no greater than emissions reductions estimates found in the provision, this action represents the 10 years from the publication date, the 2003 PM–10 Plan are based on the Agency’s first experience with ‘‘considering the severity of best available data at the time of Plan interpreting the provision in order to nonattainment and the availability and development. The District is currently determine how best to implement the feasibility of pollution control developing the Ag CMP program’s rule statute in light of the facts of an actual plan. As explained in the proposed measures.’’ Because section 189(d), and a draft list of CMP is available for approval of the Plan (69 FR 5412, 5430), standing alone, does not establish a review. As stated previously, that rule is EPA believes that the express statutory specific outer attainment deadline for not the subject of this rulemaking and language allows the District to develop areas that fail to meet their original or we will thoroughly evaluate the rule a plan that targets reductions of either (one time) extended deadline, EPA once it has been adopted by the District direct PM–10 or PM–10 precursors in adopted an interpretation reasonably and submitted to us. We note, however, each year, and to alternate or vary the accommodated to the purpose of the that while some of the CMP on the draft approach from year to year. This is a statutory provisions. Chevron U.S.A., list may already be implemented by plain reading of the statute that gives Inc. v. Natural Resources Defense some farmers, this may only mean that Council, 467 U.S. at 842–44. In contrast, effect to the word ‘‘or.’’ Even if the these farmers are already implementing statutory provision were ambiguous on the commenters’ interpretation would BACM. We also note that the latest draft write out of the statute entirely the this point, EPA believes that its of Rule 4550 contains a backstop language in section 189(d) that interpretation is reasonable, given that provision to ensure that sufficient addresses attainment. this reading of the statute provides some Finally commenters claim that ‘‘if emission reductions are achieved by the flexibility to the state to determine EPA’s interpretation were correct, EPA agricultural sector. whether it is more effective or more would be permitted to endlessly extend 3. Attainment as Expeditiously as practicable to obtain reductions of direct attainment deadlines for up to 10 year Practicable PM–10 or PM–10 precursors from year periods after each finding of to year, as the facts and circumstances nonattainment.’’ EPA has the Comment 1: CRPE comments that dictate, so long as the state is making responsibility under CAA sections because the five percent requirement progress towards attainment of the 179(d) and 188(b)(2) of determining has not been adequately addressed and NAAQS as expeditiously as practicable. within 6 months of the applicable because the Ag CMP program does not As further explained in the proposed attainment date whether an area has require BACM, the Plan does not rule, EPA believes that the express attained the standards. Once EPA demonstrate attainment will be statutory language of section 189(d) approves a specific deadline for the SJV achieved as expeditiously as authorizes the Agency to approve a plan under section 179(d)(3), it becomes the practicable. that achieves 5% reductions of either applicable deadline for the purpose of Response: Since we believe that the direct PM–10 emissions, or 5% of the such a determination. If the SJV fails to section 189(d) five percent requirement emissions of one or more precursors that meet its 179(d)(3) deadline, the has been met and that the BACM EPA determines to be the precursor provisions of section 189(d) will once requirement for agricultural sources has emissions appropriate for the District to again apply. We believe that result is also been met, we continue to believe target in order to attain the NAAQS as what Congress intended in these attainment is based on all reasonably expeditiously as practicable. EPA circumstances. achievable emissions reductions and is believes that this is a literal reading of

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the provision because the term reductions of 5% of VOC emissions less than 5% and does not indicate that ‘‘precursor’’ must be read in light of would not be as effective. With respect the plan could not allow such what the District establishes and EPA to SOX, the relatively small amount of reductions to occur earlier than would agrees are the chemicals that are the SOX emissions in the District compels otherwise be required, yet on average or PM–10 precursors for regulatory the conclusion that achieving annual when looked at as a whole, to have met purposes in the SJV. Even if the statute reductions of 5% of SOX emissions the requirement of an annual 5% were ambiguous on this point, EPA would not significantly affect the reduction. EPA notes that Congress did believes that it is appropriate to ambient PM–10 levels in the SJV. explicitly provide for required interpret section 189(d) to allow for the In short, given the PM–10 and NOX emissions reductions in each year in calculation of the 5% reduction of strategy adopted by the District and the section 187(g), which is the analogous precursors based upon the overall supporting technical analysis and provision applicable to carbon strategy of the plan. This approach is modeling they have provided, NOX is monoxide (CO) nonattainment areas that confirmed by the terms of section 189(e) the regulatory ‘‘PM–10 precursor’’ in the fail to attain by the applicable in which the statute permits EPA to SJV for purposes of section 189(d). attainment date. In that provision, the determine whether or not certain Should this determination change as a statute explicitly requires reductions of precursors from stationary sources result of further analysis in the CRAPQS ‘‘5 percent per year in each year.’’ significantly contribute to violations of study, the content of the section 189(d) Because this was not stipulated in the NAAQS, in essence distinguishing requirement would also change. section 189(d), we conclude that we are between chemicals that may be In light of these facts, EPA has permitted to take a different approach. precursors from an academic concluded that it is appropriate to read EPA believes that a plain reading of perspective and chemicals that should the provisions of section 189(d) to section 189(d) does not preclude an be precursors from the regulatory permit the District to calculate the 5% approach that permits earlier reductions perspective. Were EPA to require the reduction of PM–10 precursors based to count towards the 5% calculation for District to obtain 5% emission upon the overall strategy of the Plan, subsequent years. To the extent that the reductions of chemicals that are not the i.e., to require a 5% reduction of NOX provision is ambiguous on this point, appropriate precursor or precursors to in those years that the District is not however, EPA believes that its control, that could result in reductions obtaining a 5% reduction of PM–10. interpretation is preferable because that would not expedite attainment. EPA emphasizes that this approach is encouraging reductions earlier is more In this case, the District has designed appropriate because the strategy and the consistent with obtaining emissions a plan that targets reductions of PM–10 technical support for the strategy reductions and achieving the NAAQS and NOX, because they believe that this indicate that NOX reductions are the more quickly. EPA acknowledges that strategy will be the most effective and most effective control strategy in the the obligation to achieve the NAAQS as efficient way to reach attainment. In SJV, and that this conclusion might not expeditiously as practicable is a order to comply with section 189(d), the be appropriate in other locations with separate and simultaneous obligation, District has therefor structured its plan different mixtures of emissions, sources, yet also recognizes that legitimate to ensure that it will achieve reductions atmospheric conditions, and other plan- concerns such as the cost and technical of either PM–10 or NOX sufficient to specific considerations. feasibility of control measures might meet the 5% requirement. As explained These commenters also take issue result in decisions to delay or limit the elsewhere in more detail, EPA has with the way in which EPA has read the implementation even of BACM level evaluated the 2003 Plan as a whole and statute to allow the District to take controls. By encouraging the District’s concurs that, based upon currently credit for early reductions of PM–10 or efforts to obtain reductions sooner available information, the PM–10 and PM–10 precursors. The commenters through, e.g., the earliest possible NOX reduction strategy will be the most assert that because the statutory implementation date notwithstanding effective approach to attain the PM–10 language requires ‘‘annual reductions in resulting higher costs, EPA believes that NAAQS as expeditiously as practicable. PM–10 or PM–10 precursor emissions an interpretation of section 189(d) to Accordingly, EPA believes that the within the area of not less than 5 allow early reductions to count towards reference in section 189(d) to 5% percent of the amount of such emissions the 5% calculation for later years is emission reductions of ‘‘PM–10 as reported in the most recent inventory consistent with the larger goals of the precursors’’ should be interpreted to prepared for such area,’’ the District CAA. mean 5% of the precursors that have must obtain ‘‘at least’’ 5% reduction in EPA would not, however, agree that been determined to be effective for each year of the Plan. section 189(d) would allow achieving the NAAQS, i.e., 5% of the As explained in the proposed rule, ‘‘backloading’’ of emissions reductions type of emissions that are PM–10 EPA does not believe that the explicit to meet the 5% calculation requirement, precursors for regulatory purposes. statutory language compels this i.e., if reductions that occur in later For the 2003 Plan, for example, the approach and that such an years were counted towards the 5% District has argued and EPA agrees that interpretation of section 189(d) might requirement for earlier years. While the it would not be an effective strategy for not be the best way to encourage early statutory language of section 189(d) the District to obtain 5% reductions of reductions to achieve the NAAQS. might also be susceptible to an ammonia because this degree of Although the statute does use the term interpretation allowing backloading of ammonia reduction would not ‘‘annual reductions,’’ the statutory reductions, EPA believes that such an appreciably move the SJV towards language does not in fact use the interpretation would be inconsistent attainment given that most portions of phraseology advocated by the with the goal of the section, which is to the area appear to be NOX-limited so commenters. The provision does not move an area to attainment as that reductions of ammonia would not explicitly require reductions of 5% ‘‘in expeditiously as practicable. In be as effective. Similarly, the District each year,’’ ‘‘in each individual year,’’ addition, other provisions indicate how has argued and EPA agrees that ‘‘in each and every year,’’ or in any such Congress addressed situations in which reductions of VOC would not be as terms. The provision instead merely reduction requirement backloading useful as reductions of NOX to reduce requires that the District’s plan must might be appropriate. In section PM formation, so that achieving provide for ‘‘annual reductions’’ of not 182(c)(2)(B), Congress laid out a specific

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approach for backloading of otherwise annual reductions by adding the total 189(d) requires the 5% reductions to be required VOC reductions. By contrast, tonnage of PM–10 and NOX into one in addition to reductions achieved from were EPA to interpret section 189(d) sum and then calculating 5% of that BACM requirements since BACM rigidly to require at least 5% reductions total sum, this method would be requirements were required to be in each year as the commenters assert is mathematically incorrect. To say that implemented by 1997. CAA section absolutely required, a state might feel 2% of 100 units of PM–10 and 3% of 189(b)(1)(B); 64 FR 51489 (September compelled to schedule the 200 units of NOX equals 5% of one or 23, 1999). In addition, CRPE comments implementation of controls in order to the other or both is simply improper; 8 that EPA’s rationale that allowing ensure that it could meet the technical units would not be 5% of 100 units, 200 reductions ‘‘* * * to be carried forward requirement of at least 5% reductions in units, or 300 units. EPA contends that in order to encourage emissions each and every year in order to avoid Congress cannot have intended reductions as quickly as possible’’ the legal consequences of failure to meet application of the statute in a way that should not apply to BACM requirements that requirement. This might result in is inconsistent with basic mathematical since they were due seven years ago. decisions that were not optimal in terms principles, so this approach is not Response: The commenter is correct of obtaining emissions reductions from acceptable.38 that the 2003 Plan uses reductions as many sources as possible, as early as In EPA’s proposed rule (69 FR 5412, achieved through implementation of possible, thereby exalting the 5% 5430), the Agency recognized that the BACM level controls in order to meet requirement over the larger goals of the ‘‘Alternative Method’’ (see 2003 PM–10 the 5% requirement of section 189(d). CAA. Plan, Table 7–2) for calculating the five The commenter asserts that this is In support of their position that percent requirement ‘‘* * * [a]chieves inappropriate, given that the reductions section 189(d) does strictly require 5% the 5% annual reduction of either PM– required for BACM level of controls reductions in each and every year, the 10 or PM–10 precursors * * * [and] should already have occurred and that commenters quote a particular selection [c]arries forward any reductions beyond the 5% reduction requirement of section from the legislative history for the CAA 5% towards calculating the 5% 189(d) should be in addition to those in which the House Committee on requirement for a future year.’’ As previously required reductions. Energy and Commerce summarized the explained in the response above, EPA EPA disagrees that this is the proper provisions of H.R. 3030, and described believes that the explicit language of the way to interpret section 189(d) in this section 189(d) as requiring a state ‘‘to statute permits the District to target situation. Congress did not explicitly reduce the total tonnage of emissions of reductions of either PM–10 or PM–10 word section 189(d) to provide that the PM–10 in the area by at least 5 percent precursors in each year, and to vary the 5% reduction may not include per year in each year after submission approach from year to year, depending reductions that would otherwise occur of the plan revisions until attainment of upon whether it is more effective or as a result of the implementation of the standard.’’ See 1990 CAA Leg. Hist. more practicable to obtain reductions of BACM level controls. Instead, Congress 3021, 3292. Setting aside a debate about direct PM–10 or PM–10 precursors from simply required that a state that misses the relative weight appropriate to a year to year, as the facts and the serious area attainment date must particular piece of legislative history, circumstances dictate. In this approach, submit a plan that provides for progress EPA also believes that the quoted the District will obtain 5% reductions of towards attainment on a regular basis, language itself does not necessarily either the total amount of NOX or the and did not qualify whether these contradict the Agency’s interpretation of total amount of PM–10 in each year, or reductions should occur through the the provision with respect to giving earlier. As described in more detail imposition of RACM, BACM, or indeed credit for earlier reductions. The House above, EPA believes that allowing the any specific level of control. EPA notes Report summary merely states that the District to carry forward excess that in another provision, section provision requires a new plan that will reductions in emissions to succeeding 182(b)(1)(B), Congress did explicitly reduce emissions by at least 5% ‘‘per years is helpful because it will direct EPA to exclude certain emissions year in each year,’’ but does not encourage earlier reductions and will reductions for purposes of subsequent explicitly state that the plan could not provide practical flexibility that a strict calculations. Similarly, in section provide for earlier reductions that could numerical approach would not. 182(c)(2)(B), Congress explicitly count toward the calculation for Comment 3: CRPE comments that the directed EPA to include certain subsequent years. For the reasons stated alternative interpretation (‘‘Alternative emissions reductions in subsequent above, EPA has concluded that Method’’) allows ‘‘extra’’ emissions calculations. No such explicit directive encouragement of earlier reductions is achieved through BACM rules in 2003, appears in section 189(d). important and strict adherence to an 2004 and 2005 to be applied to later EPA believes that because the interpretation that might dissuade states years in order to meet CAA section provision does not explicitly require the from attaining reductions sooner is not 189(d). CRPE believes that section 5% reductions to be over and above the a reasonable approach to interpreting reductions that could occur through the 5% requirement. 38 If the District had wanted to achieve 5% from implementation of BACM level controls, Comment 2: Earthjustice and CRPE a combination of PM–10 and NOX, they would have it is more appropriate to interpret comment that neither of the District’s had to achieve 5% of each (i.e., 5 tons of PM–10 section 189(d) literally as a requirement and 10 tons of NOX) or it might also have been two options for demonstrating a 5% appropriate to achieve 5% of the total emissions of to implement controls that meet the annual reduction satisfies CAA section PM–10 and NOX (i.e., 15 tons total from PM–10 and percentage reduction requirement. 189(d). NOX). This approach of calculating 5% from a Nevertheless, the District is still under Response: EPA agrees that one of the single summed total of PM–10 and NOX may be an an obligation to require BACM level appropriate interpretation given the insertion of the methods proposed by the District in the word ‘‘or’’ into the statute, because the approach controls to be implemented on the 2003 Plan is unacceptable because it would at least comport with basic mathematical appropriate sources as soon as possible. would allow improper calculation of the principles. It is unnecessary to resolve this latter In addition to the 5% requirement, the 5% reduction by adding reductions of point for purposes of today’s action, however, CAA imposes a continuing obligation to because the 2003 Plan did include another option PM–10 and reductions of NOX to reach for demonstrating the 5% calculation that EPA attain the NAAQS as expeditiously as the target percentage. Unless the District believes is acceptable and consistent with the practicable. Even if the statute is determined the necessary amount of statute. ambiguous with respect to whether the

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5% reduction requirement is in addition to achieve the necessary level of 189(d) does provide an impetus for to other emission reductions, EPA controls.39 For example, with respect to regular progress towards attainment, as believes that its approach is the most BACM level controls on direct PM–10 it should. The commenter’s suggestion reasonable. EPA notes that the emissions from agricultural sources, that the 5% be above and beyond and analogous provision for CO EPA agrees that the District will need a before what is achievable through nonattainment areas, section 187(g), reasonable period of time in order to BACM level controls is not a feasible explicitly provides that a state’s plan implement the Ag CMP program. Were approach, and therefore EPA believes must use certain measures that ‘‘in EPA to adopt the commenter’s that it is not an appropriate way to combination with other elements of the approach, EPA would have to require interpret section 189(d) in the revised plan, shall be adequate to the District to meet a 5% reduction circumstances at hand. reduce the total tonnage by at least 5% requirement above and beyond the Comment 4: Earthjustice comments per year.’’ EPA believes that this reductions from BACM controls on its that the 2003 Plan includes incentive language demonstrates that Congress sources, and to obtain those reductions measures towards the calculation of the contemplated that a state would use a well before the District’s rules could mixture of measures, including reasonably achieve those reductions. 5% reductions required by section previously required or available While EPA shares the commenter’s 189(d). Because the measures are not measures, to obtain the reductions that serious concerns that the SJV should regulatory and enforceable, and because would meet the 5% reduction attain the NAAQS as expeditiously as the Plan indicates that funding for the requirement. Although section 189(d) practicable, EPA believes that it would measures has not been provided past does not include this identical ‘‘in be unreasonable to require the District 2005, the commenter asserts that the combination with’’ language, EPA to obtain reductions in advance of the reductions in the years 2005 to 2010 are believes that the existence of this time that it can practicably do so not creditable toward the 5% language in the analogous provision through BACM level controls. EPA demonstration. suggests that its reading of the statute to believes that the proper focus is on the Response: The comment appears to allow this approach for PM–10 is a requirements that the District refer to two measures in the SJV plan: reasonable one. implement BACM and that it do so in Incentive Programs (IP) and Indirect As a practical matter, EPA recognizes the manner and on the schedule that Source Mitigation Program (ISMP). The that imposition of BACM level controls will provide for the most expeditious District’s commitment to specific takes time and resources and that a state attainment of the NAAQS. In this emissions reductions from these must often sequence its efforts in order context, the 5% requirement of section measures is shown below.

SAN JOAQUIN PM–10 SIP INCENTIVE PROGRAMS AND INDIRECT SOURCE MITIGATION PROGRAM

[Emission Reductions of NOX in Tons per Day (Annual/Seasonal)]

Control measure 2005 2008 2010

Incentive Programs ...... 6.3/4.8 6.8/5.2 6.5/5.0 Indirect Source Mitigation Program ...... 0.7/0.5 2.7/2.0 4.1/3.1 Source: PM–10 Plan, Tables 4–17 and 4–18.

The IP, which has been in actual emissions reductions associated with these incentive programs are well operation since 1992, consists of various the measure: established and fully adequate to elements, including the Heavy-Duty Emission reductions projected to be validate the reductions. See, for Engine Emission Reduction Incentive achieved by completed projects and with example, the Carl Moyer Memorial Air Program, the Reduce Motor Vehicle currently committed funding amount to 6.1 Quality Standards Attainment Program Emissions (REMOVE) program for tons per day of NOX by 2005. The Air District Guidelines, electronically available at heavy-duty engines, a recently expects additional funding will be obtained http://www.arb.ca.gov/msprog/moyer/ concluded program for light- and to allow continued emission reductions in moyer.htm. later years. medium-duty vehicles, and a Green The Moyer program procedures have Yard Machine Program (electric As shown above, the District has served as models for the design of lawnmowers). The IP is a long- committed to achieve an additional 0.2 national, state, and local credit established program which is tpd of NOX reductions by 2010 beyond validation systems for mobile source continuing, using various State-Federal the level achieved in 2005 from already subsidy programs, and California funding sources, and the District has completed projects and presently continuously refines these guidelines to indicated that it will pursue new committed funding. reflect accurately the reductions funding sources to achieve additional In the SJV, there is a long track record associated with the program subsidies. 40 reductions claimed in years after 2005. of District and State funding support for The procedures address emission The commenter quotes the 2003 these incentive programs. Moreover, the reduction quantification issues Plan’s discussion of the relationship quantification and documentation of associated with both baseline emissions between current funding and the obtaining of emissions reductions from and the amount of reductions

39 Within the statutory scheme, Congress 1997. The more general point, however, is that in funds, Federal Congestion Mitigation and Air implicitly recognized that states could not developing a plan, EPA recognizes that it may not Quality Improvement Program (CMAQ), and immediately implement BACM level controls. In be possible for all controls to be implemented District Department of Motor Vehicle (DMV) section 189(b)(1)(B), the statute provides that a state instantaneously. Surcharge Fees. 2003 PM–10 Plan, page 4–62. It plan must implement BACM within four years after 40 should be noted that revenue from the $4 DMV classification or reclassification to serious PM–10 The Plan indicates that current funding sources nonattainment. In this instance, of course, BACM include California’s Carl Moyer Program, State registration surcharge fee is a permanent source of level controls should have been implemented by transportation funds, State peaker power plan offset IP funding under State law.

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achievable from the various repower, emissions reductions to count towards Congress would have inserted retrofit, and replacement technologies the 5% calculation for subsequent years. provisions similar to section and alternative fuel options, as well as Even if the statute were ambiguous on 182(c)(2)(B) into section 189(d). EPA issues associated with project life, this point, EPA believes that an disagrees with the basic assertion that enforceable requirements to ensure that interpretation that encourages states to EPA should not credit early reductions reductions must continue within the obtain the reductions earlier than might towards the 5% calculation for a nonattainment area, etc. otherwise be required consistent with number of reasons, as discussed more EPA believes that, by approving the prompt adoption and implementation of fully in other responses. In this specific Plan, EPA is approving the District’s BACM level controls and attainment of context, however, EPA notes that the enforceable commitments to continue to the NAAQS as expeditiously as bulk of the provision relevant to VOCs implement the long-established practicable, is an appropriate is necessary to specify the conditions programs in the IP to achieve the interpretation. The commenter under which EPA can allow a state to specified reductions. EPA and the disparages the approach by referring to reduce the percentage of reductions public may enforce this emission it as ‘‘banking’’ or ‘‘running averages,’’ otherwise required, not how to credit reduction obligation if the District fails but EPA contends that such an approach early emission reductions to meet the to demonstrate that the reductions have is more consistent with the overall goals percentage reduction requirement for been achieved by the milestones. EPA of the CAA and is more practical given later years. This fundamental difference therefore disagrees with the commenter what would otherwise be a potential at least suggests that EPA need not that credit towards the section 189(d) disincentive to get reductions sooner follow section 182(c)(2)(B) even by calculation for the IP is unwarranted. out of concern that there might analogy in interpreting section 189(d). While the IP is indeed an incentive otherwise be a failure to get 5% To reiterate, EPA believes that its program and relies on guidelines rather reductions in a later year. approach in effect ensures that the plan than rules, the ISMP is clearly intended With respect to the commenter’s will achieve reductions of at least 5% of to be enforced through new Rules 3180 reference to the ‘‘linear progress’’ PM–10 or 5% of PM–10 precursors each and 9510. In the plan, the District requirement of the Addendum, as year, but encourages earlier reductions commits to final implementation of the discussed in section II.F. below, that rather than discouraging them. ISMP regulations in the 4th quarter of guidance addresses linear progress with Comment 6: Earthjustice comments 2004 sufficient to achieve the projected respect to the reasonable further that because the 2003 Plan relies on a reductions shown for the milestone progress (RFP) provisions of the CAA 1.5 to 1 ratio of NOX to PM–10 years, similar to other regulatory applicable to the 2003 Plan. The (secondary nitrate) reductions for some measures. By approving the plan, EPA discussion in the guidance, however, modeling purposes, EPA should require is approving the District’s enforceable neither requires linear progress for RFP the District to use this ratio to determine commitments to implement new ISMP nor mentions at all the 5% requirement how many tons of NOX or PM–10 regulations to achieve the specified of section 189(d). Furthermore, EPA reductions are necessary to meet the reductions. When Rules 3180 and 9510 believes that strict adherence to the section 189(d) 5% requirement. The are submitted as SIP revisions, EPA will concept of a perfectly straight line on a commenter suggests that requiring the review those regulations, like the future graph representing emissions reductions District to use this ratio might cause the regulations associated with other is less important than obtaining the District to attain the NAAQS as early as committal measures, to ensure that the reductions earlier, if possible. Given the 2006, instead of its target date. rules meet applicable requirements, option, EPA would prefer that a section Response: EPA agrees that having including federal enforceability. Thus, 189(d) plan with a ten year strategy approved the NOX-PM–10 ratio for some EPA disagrees with the commenter’s obtain 50% PM–10 reductions in year purposes, it might theoretically be contention that the ISMP is an one rather than a more rigid plan that appropriate to consider requiring the unenforceable and non-regulatory provided only for a ‘‘linear’’ reduction District to use the ratio throughout the measure, and believes that it is of 5% per year for 10 years. Plan, including in the section 189(d) 5% appropriate to include it in the section Unfortunately, the difficulties of reduction calculation. However, in this 189(d) calculations. devising rules, implementing rules, and respect, EPA believes that the literal Comment 5: Earthjustice comments obtaining emissions reductions are not language of section 189(d) refers to a that section 189(d) does not allow for usually conducive to such approaches plan that will obtain reductions of ‘‘5 ‘‘running averages’’ using ‘‘banked’’ and require a balancing of what is percent of the amount of such credits from year to year to meet the technologically, economically, and emissions, as reported in the most annual 5% reduction requirement. practicably achievable. This may not recent inventory prepared for such Earthjustice also comments that the easily result in a straight line on a area.’’ The use of both the term Addendum states that annual reduction graph. ‘‘amount’’ and the reference to ‘‘the requirements require ‘‘linear progress EPA agrees with the commenter that most recent inventory’’ clearly seem to for quantitative milestones’’ for areas the statutory language of section refer to emissions in units of weight, which meet certain requirements, as the 182(c)(2)(B) explicitly directs EPA to most appropriately tons, given that this SJV does. Finally, Earthjustice states allow a state to use early reductions to is the common unit of emissions that CAA section 182(c)(2)(B) regarding meet ‘‘reasonable further progress’’ inventories. The explicit language of ozone plans specifically allows for requirements for VOC emission section 189(d) does not refer to averaging and had Congress intended reductions. These provisions do not, calculation of the required reductions of similar treatment for PM–10 plans, it however, apply to PM–10 and do not tons of PM–10 or PM–10 precursors by would have included such language in necessarily indicate or control how EPA any method that would weight them section 189(d). should interpret the different language differently or require a specific ratio Response: As discussed more fully in of section 189(d). The commenter takes between the tons of reduction. Unlike response to the commenter above, EPA the position that had Congress intended other provisions of the CAA which believes that the explicit provisions of to allow any early PM–10 or PM–10 impose an explicit obligation to make section 189(d) do not preclude an precursor reductions to count towards reductions of a given pollutant in approach that would encourage earlier the 5% requirement for later years, accordance with a set ratio; e.g., sections

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182(a)(4), 182(b)(5), 182(c)(10), does not achieve the necessary 5% met.’’ We also determined that the 2003 182(d)(2), and 182(e)(1), section 189(d) reductions. 69 FR 5412, 5430. To Plan contains quantitative milestones does not include such a requirement. illustrate this as simply as possible, which are to be achieved every three The lack of explicit language directing assuming 100 tons of PM–10 and 100 years until the area is redesignated to EPA to require a state to make the PM– tons of NOX, the District believes that a attainment. The reader is referred to the 10 or PM–10 precursor reductions on a 2% reduction in PM–10 and a 3% proposed rule for the details of our weighted or ratio basis is perhaps not reduction in PM–10 precursor should be evaluation. 69 FR 5412, 5430–1531. surprising, given that Congress may well allowed. However, this approach would There is nothing in the language of have recognized the inherent difficulties only yield 5 tons of PM–10 and NOX either section 172(c)(2) or 189(c)(1) that of specifying the proper ratio in all reductions. Since there are 200 tons of requires linear progress. In fact, section circumstances in advance in the statute. PM–10 and NOX, EPA does not believe 171(1) defines RFP as ‘‘such annual Nevertheless, had Congress desired EPA that one could argue that 5 tons is 5% incremental reductions in emissions to make the calculations on an area by of 200. Because this approach would not * * * as are required by this part [D] or area basis, one would assume that the make sense from a simple mathematical may reasonably be required by the statute would expressly direct EPA to perspective, EPA has concluded that Administrator for the purpose of ascertain the proper ratio. Given that this cannot be a proper interpretation of ensuring attainment * * * by the section 189(d) provides only that there the provision. applicable date.’’ Emphasis added. Thus must be a 5% reduction in the The existing guidance cited by the the statute provides EPA with discretion ‘‘amount’’ of the respective pollutants, commenters concerning the use of either to determine what constitutes RFP in EPA believes that the language is plain VOC reductions or NOX reductions to individual cases. on its face that tons of PM–10 or tons meet the rate of progress percentage In the Addendum, we explain that of PM–10 precursor reductions are to be requirements of other sections of the historically RFP has been met by weighted equally. CAA is simply not controlling in light showing annual incremental emission Even if the language were ambiguous, of the explicit statutory language of reductions sufficient generally to EPA believes that its interpretation, that section 189(d). The commenters also maintain at least linear progress towards the statute directs the calculation of the misread the guidance. It requires the attainment by the specified deadline. percentage based upon the weight of the calculation of reduction of NOX and Addendum at 42015. We then provide respective pollutants and a 1:1 ratio, VOCs to be either 3% of total NOX and several examples of when ‘‘[requiring would seem to be the easiest and most VOCs or 3% of NOX and 3% of VOCs. linear progress reductions may be straightforward reading of the statute Finally, EPA believes that it is not appropriate.’’ Emphasis added. Id. The and method to perform the 5% necessary to used the strained use of the word ‘‘may’’ clearly indicates calculation. Moreover, EPA notes that mathematical logic of the commenter’s that we did not intend to mandate linear the legislative history cited by the approach. As described above in progress in the cited circumstances. We commenters in support of other response to other commenters, EPA further buttress this conclusion by arguments discussed above, explicitly does believe that the District’s explaining that ‘‘EPA will determine refers to section 189(d) as requiring a alternative method for calculation of the whether the annual emission reductions plan ‘‘to reduce the tonnage’’ of 5% reduction does comport with the to be achieved are reasonable in light of emissions and makes no explicit statute, so EPA can properly approve the statutory objective to ensure timely mention of any ratio between PM–10 the plan as meeting the requirements of attainment of the PM–10 NAAQS.’’ Id. and precursors. EPA continues to section 189(d) requirements. at 42016. believe that the legislative history cited In the case of the SJV, we have by the commenters is not necessarily F. RFP Demonstration concluded that the annual incremental controlling as to Congressional intent Comment 1: Earthjustice comments reductions in PM–10 and NOX concerning the provision, but if the that an analysis of the incremental emissions are sufficient without linear legislative history is clear on any point, reductions towards attainment is not progress to meet the RFP requirements it would seem to be that the 5% provided in the 2003 PM–10 Plan. of sections 172(c)(2) and 189(c)(1). calculation is to be based on tonnage of Earthjustice believes that the 5% G. Contingency Measures emissions and there is no reference to demonstration does not satisfy the CAA setting a ratio between direct PM–10 section 172(c)(2) RFP and 189(c)(1) Comment 1: Earthjustice states that emissions and PM–10 precursors. quantitative milestone requirements as EPA’s proposed approval of the 2003 Comment 7: The SJVUAPCD it does not show linear progress toward PM–10 Plan omits any discussion of comments that EPA should approve the attainment date, which should be contingency measures required by both methods for demonstrating the 5 December 31, 2006. section 172(c)(9) and is in violation of percent requirement. In particular, the Response: The 2003 PM–10 Plan the CAA and the Agency’s own policy District argued that adding the implies that the section 172(c)(2) RFP (Addendum at 40215). The likelihood percentages of NOX and PM–10 to meet requirement is satisfied by meeting the that contingency measures will be the 5% requirement would be similar to 5% requirement. However, as discussed necessary is a virtual certainty and in the ozone rate of progress guidance in EPA’s proposed rule, ‘‘* * * RFP is fact should have gone into effect within which allows aggregation of VOC and a separate statutory requirement and is 60 days of EPA’s July 23, 2002 finding NOX reductions to achieve the 3% to be determined relative to attainment. of failure to attain. EPA has never requirement. Given that there is no EPA Thus, in order to satisfy the RFP proposed full approval of a SIP for a guidance on meeting section 189(d), the requirement, there must be an analysis serious PM–10 nonattainment area commenter believes the ozone guidance which shows that incremental without a discussion of the adequacy of for rate of progress should apply. reductions towards attainment are being contingency measures contained in the Response: As stated in the proposed made for both the 24-hour and annual plan. The District of Columbia Circuit rule, EPA does not believe that the standards. * * * [EPA’s] evaluation of Court of Appeals in Sierra Club v. EPA, method summarized in Table 7–1 the attainment demonstration coupled 294 F.3d 155 (D.C. Cir. 2002) recently satisfies the CAA section 189(d) 5% with the expected yearly emissions vacated an EPA decision to approve a requirement because adding percentages reductions shows that RFP is being SIP without the required contingency

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measures. The commenters request that 189(b). The fact that these submissions measures in the Plan. EPA intends to act EPA address the adequacy of the were to be made at different times separately on the pending contingency contingency measures in the Plan in its clearly demonstrates that EPA is not measures and will respond to all final action and then specifies the ways required to consider contingency comments on those measures at that in which they consider that the measures in its approval of the 2003 time. measures fail to meet the requirements Plan. H. Full Approval With Commitments of the Act. The severability of these provisions is Response: EPA is not required by the made even more clear by section Violates the CAA CAA or Agency policy to act on 110(k)(3), which was added as part of Comment 1: Earthjustice comments contingency measures in a SIP at the the 1990 Amendments to clarify that that the Plan must contain actual, same time that it acts on other elements EPA is not required to approve or adopted control measures to attain the of the plan. A SIP is not a single disapprove a submission as a whole, but PM–10 standard. The only enforceable document that is prepared once and may separately approve and disapprove commitments allowed by the Act are then reviewed and approved as a single different portions. It makes no sense to those pursuant to CAA section action. Rather it is a collection of say that Congress gave EPA this 110(k)(4), conditional approvals, which regulations, demonstrations, and other authority, but at the same time require a commitment by the state to items that develops over time. When the prohibited EPA from approving the adopt specific enforceable measures State revises the plan, either to change 2003 Plan without acting on the within one year of the approval. an existing element or to add additional contingency measures in it. Because the Response: Our proposed rule provides elements required by the statute, the statute clearly allows EPA to approve in detail EPA’s rationale for accepting revisions themselves, not the entire these elements of the plan without the enforceable commitments found in plan, are submitted to EPA. Thus, in considering other elements such as the 2003 PM–10 Plan (69 FR 5412, reviewing the 2003 Plan, EPA did not contingency measures, that is the end of 5427–5429). In short, EPA believes, have to consider whether the the question. Chevron, 467 U.S. at 842– consistent with past practice, that the independent requirement to have 43. CAA allows for the approval of contingency measures in the plan had Consistent with the above enforceable commitments under CAA been met. interpretation of the Act, on April 13, section 110(k)(3) that are limited in This conclusion is well supported by 2000, EPA proposed to approve certain scope where circumstances exist that the language and structure of the Act. provisions of the serious area PM–10 warrant the use of such commitments in The basic requirements of a SIP for a plan for the Phoenix, Arizona place of adopted measures. See 69 FR nonattainment area, including the nonattainment area. In the proposal, 5412, footnotes 28 and 29. The U.S. contingency plan requirement, are listed EPA stated that the ‘‘plan contains Court of Appeals for the Fifth Circuit in section 172(c). The introductory contingency measures as required by recently upheld EPA’s interpretation language, by referring to ‘‘plan CAA section 172(c)(9). We are not and specifically found that nothing in provisions’’ and ‘‘plan items,’’ makes proposing action on these contingency the CAA or in the legislative history clear that the contingency plan measures at this time. Contingency supports the theory that section provision and the other subsections of measures are a distinct provision of the 110(k)(4) (added in the 1990 this provision each set forth Clean Air Act that we may act on Amendments to the statute) was independent components of the overall separately from the attainment intended to supplant the Agency’s use plan. The specific plan revisions under requirements.’’ 65 FR 19964, 19965. See of enforceable commitments under review here are independent plan also 62 FR 1150 (January 8, 1997) and sections 110(a)(2)(A) and 172(c)(6). The requirements that are required by 65 FR 18903 (April, 10, 2000) (approval court further found that, in the 1990 separate sections of the statute, e.g., of provisions of California ozone plan Amendments to the CAA, Congress in section 189(b) and (d). revisions without acting on contingency fact expanded EPA’s authority under It is true that section 172(c)(9) refers measures in those revisions). section 110(a)(2)(A). In this respect, the to the inclusion of contingency EPA agrees with the D.C. Circuit’s court concluded that because that measures in ‘‘the plan revision.’’ It is holding in Sierra Club, 294 F.3d at 164, section ‘‘is silent on the issue of ambiguous, however, as to what plan that contingency measures are required whether an enforceable commitment is revision this section refers. For example, to be included in a SIP for a an ‘appropriate’ ‘means’ or ‘technique’ section 189(b) and (d) requires various nonattainment area. EPA does not to reach attainment, EPA’s revisions to be submitted to EPA on believe, however, that the Agency is interpretation must be upheld if the different schedules: for areas such as the prohibited from approving certain court finds it a permissible construction SJV that were reclassified from elements of the 2003 Plan without of the statute.’’ The court proceeded to moderate to serious under section acting on the contingency measures in do so. BCCA Appeal Group et al. v. 188(b)(1), the attainment demonstration the plan. As demonstrated above, these U.S.E.P.A. et al., 348 F.3d 93, 115 (5th is due within 4 years of reclassification are independent elements of the SIP that Cir. 2003). In addition, see section and the BACM demonstration no later EPA can separately approve or II.C.1. above. than 18 months from the disapprove. EPA also notes that the plan Comment 2: Earthjustice comments reclassification. EPA determined that at issue in the D.C. Circuit’s decision in that EPA does not use consistent states must submit contingency Sierra Club was an ozone plan subject methods for calculating the percentage measures for serious PM–10 areas (or to the provisions of section 182(c)(9) of commitments for NOX and PM–10. otherwise demonstrate that adequate regarding the inclusion of contingency Furthermore, EPA needs to evaluate the measures are in place) within 3 years of measures, while this plan is a PM–10 percentage of commitments used to reclassification. Addendum at 42015. plan not subject to those provisions. specifically satisfy the 5% requirement. Thus, the contingency measures Because EPA is not acting on the Response: EPA estimates that the NOX contemplated by section 172(c)(9) are contingency measures in the 2003 Plan enforceable commitments make up intended to be part of a different plan in this action, the Agency is not approximately 15–16% of the overall revision from the attainment and BACM responding to the comments raised reductions since 1999 needed for demonstrations required by section regarding the adequacy of those attainment of the annual and 24-hour

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PM–10 standards (69 FR 5412, 5428). not believe that the percentage of For example, as noted in the proposed For PM–10, EPA estimates that the enforceable commitments must be rule: enforceable commitments make up evaluated for separate CAA * * * a significant portion * * * of the approximately 72% and 92% of the requirements such as the 5% needed reductions come from the Ag CMP reductions needed to attain the annual requirement and reasonable further Program which controls agricultural fugitive and 24-hour standards, respectively, in progress demonstrations. dust sources, a previously unregulated the attainment year, 2010 (69 FR 5412, Comment 3: Earthjustice comments category. * * * measures for agricultural 5428–5429). that the ‘‘three-factor test’’ used to sources must be determined on a case-by- EPA believes that the calculation of determine the acceptability of the case basis. The Ag CMP Program is an effort the reductions in the Plan attributable to commitments is not consistent with the that is well under way as the District has worked diligently with stakeholders * * * to enforceable commitments should Act. The fact that district court include the historical and ongoing develop the best available measures for the decisions have made State commitments SJV. An enforceable commitment is reductions from already adopted enforceable does not mean that EPA can necessary at this time in order to allow the programs. This approach (which approve commitment-based plans, additional time required to further assess the Earthjustice calls the ‘‘net emissions especially since there is nothing in the dust measures that the District will establish reductions’’ method) is used in Act that allows it. Furthermore, even if for agricultural sources. * * * estimating the NO reductions where X the three-factor test is allowed, the 69 FR 5412, 5428–5429. the enforceable commitment reductions factors are not met. In contrast, Clark County did not need in 2010 are compared to the change in Response: EPA does not rely on to include any significant agricultural overall NO emissions since 1999 X district court decisions holding controls in its plan, and neither Clark which include reductions from already commitments enforceable as the basis County nor Maricopa County needed to adopted programs (i.e., state and federal for the Agency’s approval of plans evaluate and prepare control strategies mobile source and district stationary 41 containing commitments. As discussed for secondary PM, while at the same source rules). above and in our proposed rule, the For the PM–10 enforceable time developing primary PM controls. Fifth Circuit Court of Appeals in BCCA commitments evaluation, however, EPA Indeed, with the possible exception of Appeal Group recently upheld EPA’s uses a different approach. This is the South Coast area, no area in the interpretation of CAA sections because ‘‘[t]he PM–10 inventories do country has had to undertake the 110(a)(2)(A) and 172(c)(6) and the not have the same steady decline complexity of the control measure Agency’s use and application of the exhibited by the NO inventories due to development task facing the SJV, with X three factor test in approving the need to further refine the backcasted its remarkably diverse primary and enforceable commitments in the inventories for PM–10.’’ 69 FR 5412, secondary PM problem, the dominant 5428; see also 2003 PM–10 Plan, p. 4– Houston-Galveston ozone SIP. 69 FR place of agricultural controls in its 42 5412, 5427, footnote 30. In addition, as 8 to 4–9. Since using the NOX attainment strategy, and the magnitude approach does not provide a discussed below, EPA believes the three of its emissions reductions target. See comparison of the 2010 PM–10 factors have been met. also, section II.C.3., response to enforceable commitment reductions to Comment 4: Earthjustice comments comment 7. Given the prevailing the reductions from already adopted that the first factor, that the conditions in the SJV, EPA believes that programs since 1999, EPA believes that commitments address a ‘‘limited the percentage of commitments in the a better approach in evaluating the PM– portion’’ of the Plan, is not satisfied by Plan is acceptable. 10 enforceable commitments reductions the Plan and that the percentage of Moreover, the majority of the SJV’s is to compare them to the total commitments calculated by EPA is PM–10 commitments have adoption and reductions needed in the attainment extremely high. The 15–16% of implementation dates in 2004. EPA year (which Earthjustice calls the commitments for NOX reductions and noted in the proposal that ‘‘[g]iven the ‘‘annual emissions reductions’’ 72–92% of commitments for PM–10 difficulties in controlling direct PM–10 method). reductions are clearly not a limited in the SJV and the near term adoption The purpose of the percentage portion of the Plan. Earthjustice points and implementation dates, EPA believes calculations for the NOX and PM–10 out that the Maricopa County, Arizona the PM–10 reductions coming from enforceable commitments is to estimate PM–10 plan had a limited portion of enforceable commitments is the portion of the 2003 PM–10 Plan commitments which involved acceptable.’’ EPA continues to believe attributable to enforceable improvements to already adopted rules that the percentage of enforceable commitments. EPA believes the two and improving testing and enforcement, commitments for PM–10 is acceptable approaches above do just that and does and all of the BACM measures had been given these circumstances. not believe that a consistent approach previously approved by EPA. The Clark Comment 5: Earthjustice comments must be used. For this reason, EPA does County, Nevada plan’s commitments that the second factor, that the State and were for incremental reductions above District are capable of fulfilling their 41 The overall change in NOX emissions since an already adopted baseline with commitment, is also not satisfied by the 1999 also includes emissions from growth. Thus, substantial immediate reductions. These plan. Earthjustice does not understand EPA believes this approach may provide a higher commitment percentages far exceed the percentage estimate of enforceable commitments how ongoing development, past records since the additional reductions necessary to offset 6% found to be reasonable by the Fifth of accomplishment and a promise to any growth are not included in the percentage Circuit Court [in BCCA Appeal Group] fulfill the reduction commitments show calculation. for the Houston SIP. that they are capable of fulfilling their 42 According to the 2003 PM–10 Plan, ‘‘[o]ne Response: The enforceable reason for the apparent increase in growth in PM10 commitments. Instead, Earthjustice in the mid-1990s is that a significant new emissions commitment component in the SJV plan notes the District’s history of failures inventory category, prescribed burning, totaling is higher than for other areas such as and believes there is no basis for EPA approximately 23 tons per day, was added to the Maricopa and Clark Counties; however, to conclude that the District will fulfill emissions inventory in the late 1990s and was not back cast into prior year inventories. With that we believe that the percentages must be the Plan’s commitments. correction, the PM10 inventory will show a small evaluated on a case-by-case basis since Response: EPA disagrees and believes decline during that period. * * *’’ Id. each area’s circumstances are different. that ongoing development, past record

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of accomplishments and a promise (i.e., approximately 56.5 tpd, have final demonstration within a year of the final enforceable commitment) to fulfill the implementation dates by 2004. action. The BACM limited disapproval reduction commitments do indicate that Approximately 9.9 tpd of the committed identified as deficiencies SJVUAPCD’s the District and State are capable of emissions reductions will occur after failure to submit a BACM demonstration fulfilling their commitments. As 2004 from Cotton Gins, Regulation VIII for Regulation VIII or to make discussed in our proposed rule (69 FR unpaved road measure, the Indirect appropriate upgrades to Regulation VIII 5412, 5429), examples of ongoing Source Mitigation Program and the State to ensure that it meets BACM development include the Ag CMP and Federal Measures. Table 4–16 requirements. Failure to meet the Program, Regulation VIII revisions and shows that approximately 63.5 tpd have condition of the conditional approval or the State’s mobile source measures. All final implementation dates by 2004 and address the deficiencies identified in of these programs are well on their way approximately 10.2 tpd of the the limited disapproval would have FIP towards adoption and implementation. reductions will occur after 2004. Tables and sanctions consequences under CAA In addition, the State’s long history of 4–17 and 4–18 summarize the sections 110(c) and 179(a). However, as success in adopting new and reductions and final implementation previously discussed, SJVUAPCD met challenging mobile source controls is a dates coming from the NOX the condition of the conditional good indication that they will be commitments. For NOX, the portion of approval and addressed the BACM capable of meeting their enforceable reductions coming from commitments deficiencies by including in the 2003 commitments. Finally, in the event that with implementation dates beyond 2004 PM–10 Plan adequate RACM/BACM the Plan’s category-specific enforceable is much higher (i.e., approximately 34.3 demonstrations and commitments to commitments cannot be met, the District tpd for the annual inventory and 34.0 upgrade Regulation VIII. See EPA’s TSD has also committed to ‘‘* * * adopt, tpd for the seasonal inventory); for the 2003 PM–10 Plan, January 27, submit and implement substitute rules however, many of the NOX reductions 2004, pages 14–45). Therefore, this final and measures that will achieve relied upon by the 2003 PM–10 Plan are action appropriately stops all FIP and equivalent reductions in the same from already adopted measures which sanctions clock implications of EPA’s adoption and implementation will yield substantial reductions. February 26, 2003 and earlier actions timeframes.’’ SJVUAPCD Governing As noted by Earthjustice, the regarding Regulation VIII.44 Board, Resolution No. 03–06–07, #10, residential space heating commitment June 19, 2003. The commitments in the has a final implementation date of 2020, I. Adoption of All Feasible Measures 2003 Plan are for requirements and modeled after the Bay Area Air Quality (Section 179(d)(2)) for Ag CMP Program reductions that the District and State are Management District’s program (2003 Comment 1: CRPE comments that the capable of meeting and are enforceable PM–10 Plan at 4–46); however, the Plan proposed approval does not address by EPA and the public. only relies on 0.1 tpd of reductions from CAA section 179(d)(2) which states that Comment 6: Finally, Earthjustice this category which will be achieved in a SIP revision ‘‘* * *shall include such comments that the third factor, that the 2010. additional measures as the commitments are for a reasonable and Finally, as discussed above in Administrator may reasonably appropriate period of time, is not response to comment 4 in this prescribe, including all measures that satisfied by the Plan. For many subsection, the nonattainment situation can be feasibly implemented in the area categories the implementation dates in the SJV is much more complex than in light of technological achievability, extend beyond 2004 and even as far as for most other areas, such as Maricopa costs, and any nonair quality and other 2020 for residential space heating. County, and EPA believes that a case- air quality-related health and Furthermore, implementation dates by-case evaluation of the needs for each environmental impacts.’’ CRPE beyond 2004 are unreasonable in light area is warranted in determining comments that the CMP concept allows of the past delay (e.g., BACM should whether commitments should be agricultural sources to select at least one have been implemented by 1997) and accepted. In this regard, we note that the practice from each category and that this severity of the Valley’s nonattainment Ag CMP program is extensive and conflicts with the requirement for all problem. Finally, Earthjustice notes that complicated and believe that the District feasible measures as stated by section Maricopa County’s SIP commitments all is working diligently to ensure that the 179(d)(2). had deadlines of less than one year after program meets the 2004 implementation Response: CRPE misinterprets CAA their approval and that the District has deadline in their commitment. section 179(d)(2) which provides, already slipped on the Ag CMP program Comment 7: CRPE comments that among other things, that SIP revisions deadlines. EPA’s decision to stop the Regulation triggered by a failure to attain under Response: EPA continues to believe VIII sanctions and FIP clocks based on section 179(d)(1) ‘‘* * *shall include that overall the commitments are for a a PM–10 Plan with commitments additional measures as the reasonable and appropriate period of violates the CAA sections 110(c) and Administrator may reasonably time, especially given the circumstances 179(a). prescribe, * * *’’ Emphasis added. It is in the SJV (see response to comment 4 Response: As discussed above, EPA clear from the plain language of this in this subsection). Tables 4–15 and 4– believes the enforceable commitments provision, i.e., the use of the word 43 16 (2003 PM–10 Plan, 4–52) in the 2003 PM–10 Plan are approvable ‘‘may’’ rather than ‘‘shall,’’ that summarize the reductions and final for overall plan purposes as well as for Congress intended the Administrator’s implementation dates coming from the other nonattainment area requirements, action here to be permissive rather than PM–10 commitments. Table 4–15 shows such as RACM and BACM. On February mandatory. Under this provision, that the majority of the emissions 26, 2003, EPA finalized a conditional reductions coming from commitments, approval of Regulation VIII for RACM 44 In a separate action raising different issues, purposes and simultaneously finalized a certain organizations have filed an appeal with the 43 Tables 4–15 and 4–16 represent the estimated limited approval and limited Ninth Circuit Court of Appeals challenging EPA’s emissions reductions from commitments for the disapproval of Regulation VIII for February 23, 2003 action on Regulation VIII, See annual and seasonal inventories, respectively. The Latino Issues Forum et al. v. U.S. EPA, appeal annual inventory is representative of the annual BACM purposes (68 FR 8830). The docketed, No. 03–70987; Associations of Irritated PM–10 standard and the seasonal inventory is conditional approval required Residents v. U.S. EPA, appeal docketed, No. 03– representative of the 24-hour PM–10 standard. SJVUAPCD to provide to EPA a RACM 71696 (9th Cir. March 4, 2003).

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therefore, EPA has the option to comment that the Indirect Source a windblown dust problem to anywhere mandate specific additional feasible Mitigation Program does not meet CAA near the extent of the other [PM–10] measures beyond those measures criteria requiring control measures to nonattainment areas. Examination of otherwise required in nonattainment provide quantifiable, surplus, Caltrans data for the southern San areas. EPA is not, however, required to enforceable, permanent, and adequately Joaquin Valley reveals that in the year prescribe such measures. supported reductions in air emissions. 2002, Caltrans posted signs warning of The 2003 Plan does, however, need to Thus, CBIA recommends that the low visibility due to windblown dust address the requirements of section measure should not be approved. during all months of the year. Some 189(b)(1)(B) that BACM be applied to all Response: See section II.E., response locations had warnings posted four significant sources such as agricultural to comment 4. different times during the year. sources covered by the CMP program. L. Windblown Dust Issues Response: Caltrans windblown dust We have determined that the CMP postings are based on field observations program will expeditiously achieve a Comment 1: A commenter (C. by Caltrans employees, as opposed to BACM level of control. We have also Swanson) cites an excerpt from the PM– measured PM–10 concentrations. They concluded that the Plan provides for 10 Plan, Appendix G, Table G–15 do not reveal whether exceedances of attainment of the PM–10 standards as ‘‘BACM Comparative Analysis for ‘‘On- the PM–10 standards occurred at the expeditiously as practicable. Therefore Field Activities’’ concerning the BACM locations of the postings. Therefore, we did not believe it necessary to justification discussion associated with neither the District nor EPA can rely on require additional measures pursuant to the ‘‘Other’’ category of the District’s them for purposes of identifying PM–10 section 179(d)(2). Thus, since the proposed Ag CMP: exceedances. The Caltrans-reported provision of section 179(d)(2) cited by The SJV does not have a windblown dust events generally do not correlate with the commenters is discretionary and problem to anywhere near the extent of the days on which PM–10 monitors since EPA has not chosen to prescribe other nonattainment areas. The SJV has some exceeded the PM–10 standards.46 This any additional SIP measures under it, of the lowest average wind speeds in the means that the Caltrans-reported events country. No wind related exceedances have neither the 2003 PM–10 Plan nor EPA’s been recorded in the basin during the last are not being recorded by the monitors proposed rule was required to address three years. Wind speeds are highest during and are therefore spatially limited. The it. the spring when PM–10 levels are at their District’s monitors have detected some lowest. The majority of the fugitive dust high hourly rates downwind for a few J. Approval of Commitments for VOC emissions are generated from earth disturbing of the events, but not for substantial Sources—Wineries activities. Certain soil types and crops are enough periods that the 24-hour PM–10 Comment 1: The Wine Institute and more prone to windblown dust problems. standard is exceeded.47 the Manufacturers Council of the The ‘‘Other’’ category will give the farmers Comment 3: C. Swanson disputes the Central Valley comment that a great deal with the potential to experience wind blown dust emissions the flexibility to address this following statement in the PM–10 plan: of work has been done in evaluating issue with a CMP. ‘‘The SJVAB has some of the lowest VOC emissions from wine fermentation. average wind speeds in the country. No The commenter states that this excerpt Commenters state that past work has wind related exceedances have been provides a synopsis of the PM–10 Plan’s indicated that winery controls were recorded in the basin during the last characterizations of airflow in the valley technically feasible, but not cost three years.’’ Commenter states that and how it relates to the regulation of effective. Commenters provided data while large areas in the center of the agricultural land use. The commenter that indicate winery emissions are valley have very low average wind believes the Plan’s characterizations do overestimated and state that the District speeds, large areas around the periphery not adequately portray the conditions in has failed to include this information. of the basin can be subject to periods of the entire valley and may not lead to Commenters ask EPA to remove this high wind velocity and windblown proper regulatory actions. The source category from the PM–10 Plan dust. The current siting of monitoring commenter states that his study of the prior to EPA approval. stations does not capture the air flow conditions of one dust storm on June 20, Response: Under the Act, states have patterns on the western side of the 2002 in Northwest Kern County primary responsibility for regulating air valley in Kern County and therefore contradicts the statements in the excerpt quality within their borders. Under CAA cannot be used to represent conditions and that wind events on this side of the section 110(k)(3), EPA has an obligation in Western Kern County. to act on State submittals. While we do valley appear to have an episodic Response: The ambient monitoring not believe a rule for wineries is component related to a regular summer network for the SJV operated by the required for purposes of satisfying the cycle of heating and cooling in the SJV. District and CARB was designed to meet Response: Below we respond to the section 182(b)(1)(B) BACM the requirements of EPA regulations at commenter’s specific comments on the requirement,45 we do believe that such 40 CFR part 58. Monitoring for statements cited from the Plan. In a rule will strengthen the SJV’s SIP, representative air flow patterns is not general, however, the information in especially since VOC reductions are one of the criteria used to design a Appendix G, Table G–15 reflects needed for ozone attainment. Thus, EPA criteria pollutant monitoring network. monitored PM–10 exceedances and the is approving the commitment under The SJV 2003 PM–10 Plan did utilize District’s analysis of meteorological data sections 301(a) and 110(k)(3) as meteorological data from the District’s on exceedance days. In contrast, the strengthening the SIP. ambient monitoring network as well as data provided by the commenter is not other non-district monitoring networks, K. Approvability of Indirect Source sufficient to support the conclusions such as the Automated Surface Mitigation Measure made with regard to regulatory actions, Observing System (ASOS) sponsored by given that wind speed data alone does Comment 1: The California Building the Federal Aviation Administration, Industry Association (CBIA) and its not provide evidence of PM–10 concentrations. Affiliate Associations located in the SJV 46Letter from James Sweet, SJVUAPCO, to Doris Comment 2: C. Swanson disagrees Lo, EPA Region 9, April 15, 2004, page 2 (4/15/04 45 See above comments and responses in section with the Plan’s assessment that the San letter). II.A.2. and C.11. Joaquin Valley Air Basin does not have 474/15/04 letter, page 2.

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National Weather Service, the U.S. create slope flows.48 The District’s exceedances.53 Only five PM–10 Department of Defense, and the meteorological analysis of wind speeds exceedance days spanning a 13-year California Irrigation Management associated with measured PM–10 period were identified as associated Information System (CIMIS), in exceedances found that they largely with strong winds.54 The PM–10 Plan evaluating episodes for exceedance days occurred during periods of low winds does recognize that windblown dust can at PM–10 monitors in the SJV. These and stagnant conditions in the fall and occur from agricultural disturbed networks included many meteorological winter.49 surfaces by including windblown sites in the western and southwestern Comment 5: C. Swanson states that measures in the ‘‘Other’’ category in the portions of the SJV. During the episodes CIMIS data for Blackwells Corner proposed Ag CMP Program. studied, high wind speeds were not indicates several days throughout the year with sustained periods of high M. Transportation Conformity and the observed at these western and Trading Mechanism southwestern meteorological sites. wind velocity that exceed the 13 mph ‘‘Meteorological Analysis Applied to the wind velocity threshold described in the Comment 1: The commenter (TPAs) San Joaquin Valley Air Pollution PM–10 Plan as a point of possible references the trading mechanism Control District’s 2003 PM–10 State entrainment of geological material.50 discussion in the proposed rule (69 FR Implementation Plan,’’ SVUAPCD, The commenter provides a table of the 5412, 5416–5417). This section of the DRAFT (May 29, 2003). The District aforementioned CIMIS wind data for proposal discusses the transportation acknowledges that no definitive Blackwells Corner. The commenter conformity trading mechanism. The statement can be made about peak PM– states that data from the nearby Lost commenter requests a clarification on 10 concentrations at Blackwells Corner Hills National Oceanic and Atmospheric the requirement for a new analysis of absent a PM–10 monitoring site near the Administration (NOAA) vertical profile the emission trading, for subsequent location; however, there are insufficient corroborates the CIMIS data and some of conformity findings, once the U.S. resources to saturate the valley with the longest periods of sustained high Department of Transportation (DOT) has monitoring sites at a density that would winds are during the summer months approved a conformity finding which be required to establish a definitive case when local soils may be dryer and have relied upon the trading mechanism. for the entire Valley. Id., page 2. In disturbed surfaces from agricultural Specifically, the commenter requests accordance with EPA regulations, the activities. that a new analysis of emissions trading District’s monitoring sites are selected to Response: We agree that CIMIS data be completed only when a new regional evaluate exposure of populated areas to indicates several days throughout the emissions analysis is required for the adverse air quality caused by year in the Blackwells Corner area with new conformity finding. Response: EPA agrees with the anthropogenic activity. Low population sustained periods of wind velocity commenter that a new analysis of on the west side of the SJV has resulted capable of elevating fugitive dust from disturbed surfaces.51 However, based on trading is only required when a new in a lack of monitors in that area. Id., this information alone, we cannot regional emissions analysis is also pages 1 and 7. EPA has evaluated the conclude that the Blackwells Corner required. Once the U.S. DOT has adequacy of the PM–10 monitoring area or other areas in its immediate approved a conformity finding which network for the SJV and concluded that downwind vicinity are experiencing relied upon the trading mechanism, the ‘‘* * * the network meets all PM–10 exceedances. The Blackwells transportation planning agency cannot applicable statutory and regulatory Corner wind velocities are not necessarily rely on that trading scenario requirements and is adequate to support representative of typical wind velocities for future conformity findings that the technical evaluation of the PM–10 in other parts of the SJV, as evidenced require a new regional emissions nonattainment problem in the by the District’s compilation of wind analysis. [District’s] plan.’’ Evaluation of the speed data associated with PM–10 Comment 2: The commenter (TPAs) Adequacy of the Monitoring Network exceedance days. The District also requests that the proposed rule, for the San Joaquin Valley, California for conducted a specific analysis of the which states that the trading mechanism the Annual and 24-Hour PM–10 days on which CIMIS sites at Blackwells can only be used once approved by Standards; Bob Pallarino, EPA Region 9, Corner and other west-side CIMIS sites EPA, be modified to state that the Air Division; September 22, 2003. historically recorded elevated winds.52 trading mechanism could be used upon Comment 4: C. Swanson states that While one-in-six-day monitoring an EPA finding that a budget is 2002 wind speed data collected at a captured a representative sample of adequate. The commenter feels that CIMIS station in Blackwells Corner days where CIMIS sites recorded existing language permits use of trading documents periods of high wind elevated winds (18% coincidence), the once budgets in the SIP are adequate. velocity during all times of the year, District did not find a correlation of Response: The commenter is correct contrary to the PM–10 Plan’s statement those days with observed PM–10 that if an area has a trading mechanism that wind speeds are highest during the in an approved SIP for a criteria spring when PM–10 levels are at their 48 Id., page 1. pollutant, and that trading mechanism lowest. The Blackwells Corner data 49 One recent exception is a May 20, 2002 permits the trading of precursors and/or shows that more wind events occur Bakersfield-Golden exceedance that the District the pollutant, then the language of 40 during the summer period than the attributes to a large-scale wind episode involving thunderstorms and hail. 4/15/04 letter, page 2. CFR 93.124(c), the conformity rule, does winter/spring period. 50 Commenter also cites a 2003 report by V. permit trading to occur among Response: The statements in the PM– Etyemezian of Desert Research Institute in support pollutants or precursors for budgets 10 Plan cited by the commenter of relying on 13 mph as the appropriate wind once EPA finds the budgets adequate. concerning wind velocity provide an velocity threshold needed to generate fugitive dust. 51 The District acknowledges that CIMIS data However, the trading mechanism must accurate, general characterization of the reports 118 days in the Blackwells Corner area with be approved as part of the SIP before it SJV. The District acknowledges that winds over 13 mph. can be used, even if adequate or exceptions to the characterization of low 52 The District’s analysis reviews CIMIS wind approved budgets already exist. Section wind speeds occur in passes, along speed data between 1990 and the present for the top one-hundred values of maximum hours observed ridges, on mountainous terrain and 53 with winds over 13 mph, as well as with other 4/15/04 letter, pages 3–4. other areas of terrain influence that related data sets. 54 Id., page 4.

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93.124(c) only allows trading among both actions by U.S. DOT and by MPOs evidence. Commenter stated that the budgets for the purposes of conformity in adopting conformity documents. This PM–10 standard was last revised in if there is an approved mechanism in requirement is not a new requirement. 1987 and more recent studies needed to the SIP to allow trading to take place. Section 176(c) of the Clean Air Act be addressed. The provision in § 93.124(c) specifically clearly states that conformity applies in Response: The purpose of the 2003 states that: nonattainment and maintenance areas. PM–10 Plan is to achieve the PM–10 [a] conformity demonstration shall not Section 176(c) also states that the standards in the SJV. Evaluation of the trade emissions among budgets which the Federal government and MPOs cannot PM–10 standards is outside the scope of applicable implementation plan (or approve transportation activities unless the 2003 PM–10 Plan and this implementation plan submission) allocates they conform to a SIP, and SIPs are rulemaking. In addition to the PM–10 for different pollutants or precursors, or established for a nonattainment or standards, EPA has promulgated among budgets allocated to motor vehicles maintenance area. In a nonattainment or standards for PM–2.5 (40 CFR 50.7) and and other sources, unless the implementation maintenance area with more than one plan establishes appropriate mechanisms for is currently developing guidance for such trades. MPO, all MPOs must conform even if their implementation. the SIP has established subarea budgets. Comment 3: CRPE comments that the Emphasis added. The references to the If an individual MPO lapses, it has not 2003 PM–10 Plan fails to comply with ‘‘applicable implementation plan’’ and demonstrated that it can conform to its the requirements of the CAA and that the ‘‘implementation plan’’ in the subarea budgets. Therefore, there is no EPA’s approval of the Plan is nothing second and last line of this paragraph way for the other MPOs to show that more than an attempt to avoid are consistent with the definition for their planned transportation activities promulgating a Federal Implementation ‘applicable implementation plan’ in still conform to the SIP until the lapse Plan (FIP). § 93.101 of the conformity rule. The is resolved. Response: EPA’s proposed approval definition states that: ‘‘Applicable Comment 4: The commenter (Earth implementation plan is defined in provides detailed discussions of how Matters) also requests that EPA add each of the CAA requirements are section 302(q) of the CAA and means clarification that this requirement and the portion (or portions) of the adequately addressed by the 2003 PM– associated clarifying language apply 10 Plan. When possible, EPA prefers implementation plan, or most recent solely during a conformity lapse that revision thereof, which has been approving a State’s plan requirements in results from a Transportation lieu of promulgating a FIP. We have approved under section 110, or Improvement Plan (TIP) or Regional promulgated under section 110(c), or expedited our rulemaking to avoid a FIP Transportation Plan (RTP) expiration for the SJV, but we do not believe that promulgated or approved pursuant to only. regulations promulgated under section we proposed to approve an Response: EPA disagrees with the unapprovable plan. 301(d) and which implements the commenter. In an area with subarea Comment 4: EPA received comments relevant requirement of the CAA.’’ budgets and more than one MPO, if (LaSalle) that the public comment Furthermore, the reference to the conformity for one MPO lapses for any period does not meet the requirements implementation plan submission is in reason, the other MPOs in the area of due process. Given the complexity regard to any SIP which establishes cannot determine conformity until the and technicality of the 2003 PM–10 budgets, not one which establishes a first MPO resolves its lapse. This Plan, comment suggests 180 days as a trading mechanism. prohibition on other MPOs applies more appropriate timeframe for public EPA does not make adequacy findings whether the conformity lapse is caused review and comment. on trading mechanisms in submitted by the expiration of a transportation Response: EPA provided a 30-day SIPs. EPA’s adequacy review is limited plan or TIP, or any another reason, such comment period which was extended to determining whether the budgets in as failure to determine conformity for an additional 2 weeks, until March a SIP meet the criteria in § 93.118(e)(4). within 18 months of approval of a SIP 19, 2004. The 2003 PM–10 Plan is a For more information regarding that establishes new budgets. adequacy, please refer to the preamble In an area with more than one MPO, complicated document; however, prior of EPA’s June 30, 2003, proposed rule, if one MPO lapses, the other MPOs in to the publication of EPA’s proposed which includes our current adequacy the area would not lapse immediately. rule, the District and State held public policy to date (68 FR 38979–38984). Instead, the other MPOs can still processes to discuss the Plan with the Comment 3: The commenter (Earth proceed with projects in their current public. Numerous workshops were held Matters) references the proposed rule at TIPs. However, these other MPOs could prior to the SJV’s Board’s adoption of page 5415 (Section IV.B.2., second to not make new conformity the 2003 PM–10 Plan in June 2003. last paragraph, fourth sentence and determinations until the lapsing MPO Following that adoption, the State also Footnote 7). This section of the proposal resolves the lapse by re-establishing provided a comment and response discusses the interconnections between conformity for its plan and TIP. period before its adoption of the Plan conformity findings for subarea budgets and submittal to EPA. by the multiple Metropolitan Planning N. Other Comments Comment 5: EPA received comments Organizations (MPOs) in the SJV. The Comment 1: Several commenters (Jones) complaining about pollution proposal clarified that if an individual noted the health issues caused by PM– from a cement plan in Tehachapi, MPO could not show conformity to their 10 and other pollutants. Commenters California. Commenter wanted controls individual county budget, then the wanted clean air as soon as possible and found in SJV’s Regulation VIII applied remaining MPOs in the SJV cannot no more delays. to the source. make any new conformity Response: EPA believes that the 2003 Response: Tehachapi, California is determinations. The commenter PM–10 Plan provides a road-map located in Eastern Kern County, outside requests that this requirement apply to towards meeting the PM–10 standards of the SJV PM–10 nonattainment area. Federal actions only. as soon as possible for the SJV. EPA Region 9 Enforcement Office and Response: EPA cannot clarify that the Comment 2: One commenter (LaSalle) the Kern County Air Pollution Control action applies to Federal actions only stated that the PM–10 standards and Office has been notified of the since this requirement does apply to plan are built upon insubstantial complaint.

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III. EPA Action proposed rule on the 2003 PM–10 Plan and responsibilities established in the EPA is finalizing its approval in a table printed at 69 FR 5416. As Clean Air Act. This rule also is not pursuant to CAA section 110(k)(3) the proposed, we are limiting this approval subject to Executive Order 13045 following elements of the 2003 PM–10 to last only until the effective date of ‘‘Protection of Children from our adequacy findings for new Environmental Health Risks and Safety Plan as meeting the CAA requirements 55 applicable to serious PM–10 replacement budgets. The trading Risks’’ (62 FR 19885, April 23, 1997), nonattainment areas that have failed to mechanism is discussed in EPA’s because it is not economically meet their attainment date: proposed rule at 69 FR 5416. significant. (1) EPA is approving the emissions IV. Statutory and Executive Order In reviewing SIP submissions, EPA’s inventories as meeting the requirements Reviews role is to approve state choices, of section 172(c)(3). Under Executive Order 12866 (58 FR provided that they meet the criteria of (2) EPA is approving the RACM/ 51735, October 4, 1993), this action is the Clean Air Act. In this context, in the BACM demonstration for all significant not a ‘‘significant regulatory action’’ and absence of a prior existing requirement PM–10 and NOX sources in the SJV as therefore is not subject to review by the for the State to use voluntary consensus meeting the requirements of sections Office of Management and Budget. For standards (VCS), EPA has no authority 189(a)(1)(C) and 189(b)(1)(B). Approval this reason, this action is also not to disapprove a SIP submission for of this demonstration with respect to subject to Executive Order 13211, failure to use VCS. It would thus be fugitive dust sources regulated by ‘‘Actions Concerning Regulations That inconsistent with applicable law for SJVUAPCD Regulation VIII terminates Significantly Affect Energy Supply, EPA, when it reviews a SIP submission, all sanction, FIP, and rule disapproval Distribution, or Use’’ (66 FR 28355, May to use VCS in place of a SIP submission implications of our February 26, 2003 22, 2001). This action merely approves that otherwise satisfies the provisions of action. 68 FR 8830. state law as meeting Federal the Clean Air Act. Thus, the (3) EPA is approving, as meeting the requirements and imposes no additional requirements of section 12(d) of the requirements of sections 179(d)(3) and requirements beyond those imposed by National Technology Transfer and 189(d), (a) the attainment state law. Accordingly, the Advancement Act of 1995 (15 U.S.C. demonstration, associated motor vehicle Administrator certifies that this rule 272 note) do not apply. This rule does budgets and trading mechanism; (b) will not have a significant economic not impose an information collection commitments to adopt and implement impact on a substantial number of small burden under the provisions of the new, identified stationary, area and entities under the Regulatory Flexibility mobile source BACM to reduce PM–10 Paperwork Reduction Act of 1995 (44 Act (5 U.S.C. 601 et seq.). Because this U.S.C. 3501 et seq.). and NOX emissions; (c) a commitment rule approves pre-existing requirements for the Indirect Source Mitigation under state law and does not impose The Congressional Review Act, 5 Program; (d) a commitment for 10 tpd of any additional enforceable duty beyond U.S.C. 801 et seq., as added by the Small NOX and 0.5 tpd of PM–10 reductions that required by state law, it does not Business Regulatory Enforcement from State mobile source measures; (e) contain any unfunded mandate or Fairness Act of 1996, generally provides and the commitment to submit a SIP significantly or uniquely affect small that before a rule may take effect, the revision by March 31, 2006 based on a governments, as described in the agency promulgating the rule must mid-course review that will include an Unfunded Mandates Reform Act of 1995 submit a rule report, which includes a evaluation of the modeling from the (Public Law 104–4). copy of the rule, to each House of the CRPAQS and the latest technical This rule also does not have tribal Congress and to the Comptroller General information (inventory data, monitoring, implications because it will not have a of the United States. EPA will submit a etc.) to determine whether the level of substantial direct effect on one or more report containing this rule and other emission reductions in the 2003 PM–10 Indian tribes, on the relationship required information to the U.S. Senate, Plan is sufficient to attain the PM–10 between the Federal Government and the U.S. House of Representatives, and standards. Indian tribes, or on the distribution of the Comptroller General of the United (4) EPA is approving under section power and responsibilities between the States prior to publication of the rule in 110(k)(3) and 301(a) as strengthening Federal Government and Indian tribes, the Federal Register. A major rule the SIP the commitments to adopt and as specified by Executive Order 13175 cannot take effect until 60 days after it implement VOC and SOx measures. (65 FR 67249, November 9, 2000). This is published in the Federal Register. (5) EPA is approving the NOX and action also does not have Federalism This action is not a ‘‘major rule’’ as PM–10 emissions levels necessary to implications because it does not have defined by 5 U.S.C. 804(2). meet the 5% annual reduction substantial direct effects on the States, requirement in section 189(d). on the relationship between the national Under section 307(b)(1) of the Clean (6) EPA is approving the reasonable government and the States, or on the Air Act, petitions for judicial review of further progress demonstration as distribution of power and this action must be filed in the United meeting the requirements of section responsibilities among the various States Court of Appeals for the 172(c)(2) and 189(c)(1). levels of government, as specified in appropriate circuit by July 26, 2004. (7) EPA is approving the Plan as Executive Order 13132 (64 FR 43255, Filing a petition for reconsideration by meeting the quantitative milestones August 10, 1999). This action merely the Administrator of this final rule does requirement in section 189(c)(1). approves a state rule implementing a not affect the finality of this rule for the (8) EPA is approving the PM–10 and Federal standard, and does not alter the purposes of judicial review nor does it NOX motor vehicle emission budgets for relationship or the distribution of power extend the time within which a petition purposes of transportation conformity for judicial review may be filed, and for 2005, 2008, and 2010 and the 55 For further discussion of the rationale for, and shall not postpone the effectiveness of associated trading mechanism for effect of, this limitation, please see the proposed such rule or action. This action may not rule at 69 FR 5415, and EPA’s promulgation of a be challenged later in proceedings to demonstrating conformity for years after limitation on motor vehicle emission budgets 2010, under CAA section 176(c)(2)(A). associated with various California SIPs, at 67 FR enforce its requirements. (See section These budgets are reproduced in EPA’s 69139 (November 15, 2002). 307(b)(2).)

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List of Subjects in 40 CFR Part 52 Subpart F—California to 4–55), adopted on June 19, 2003, and ‘‘Regional Transportation Planning Environmental protection, Air ■ 2. Section 52.220 is amended by Agency Commitments for pollution control, Incorporation by revising paragraph (c)(317) and adding Implementation,’’ dated April 2003 reference, Intergovernmental relations, paragraph (c)(327) to read as follows: (Volume 3). Nitrogen oxides, Particulate matter, Reporting and recordkeeping § 52.220 Identification of plan. * * * * * requirements, Volatile organic (c) * * * (327) The following plan was compounds. (317) The plan and amended submitted on December 30, 2003 by the Governor’s designee. Dated: April 28, 2004. regulation for the following APCD were Deborah Jordan, submitted on August 19, 2003, by the (i) Incorporation by reference. Governor’s designee. Acting Regional Administrator, Region IX. (A) San Joaquin Valley Unified Air (i) Incorporation by reference. Pollution Control District. ■ (A) San Joaquin Valley Unified Air Part 52, Chapter I, Title 40 of the Code (1) Amendments to the 2003 San Pollution Control District. of Federal Regulations is amended as Joaquin Valley Plan to Attain Federal follows: (1) Rule 4901, adopted on July 15, 1993 and amended on July 17, 2003. Standards for Particulate Matter 10 PART 52—[AMENDED] (2) 2003 PM10 Plan, San Joaquin Microns and Smaller, adopted Valley Plan to Attain Federal Standards December 18, 2003. ■ 1. The authority citation for part 52 for Particulate Matter 10 Microns and * * * * * continues to read as follows: Smaller (all except ‘‘Contingency [FR Doc. 04–11667 Filed 5–25–04; 8:45 am] Authority: 42 U.S.C. 7401 et seq. Control Measures’’ section, pages 4–53 BILLING CODE 6560–50–P

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Part III

Environmental Protection Agency 40 CFR Part 52 Final Determination To Extend Deadline for Promulgation of Action on Section 126 Petition From North Carolina; Final Rule

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ENVIRONMENTAL PROTECTION questions, contact Carla Oldham, U.S. cease operations within 3 months of the AGENCY EPA, Office of Air Quality Planning and finding, except that those sources may Standards, Air Quality Strategies and continue to operate if they comply with 40 CFR Part 52 Standards Division, C539–02, Research emission limitations and compliance [OAR–2004–0076; FRL–7667–3] Triangle Park, NC 27711, telephone schedules that EPA may provide to (919) 541–3347, e-mail at bring about compliance with the Final Determination to Extend Deadline [email protected]. For legal applicable requirements. for Promulgation of Action on Section questions contact Howard J. Hoffman, Section 126(b) further provides that 126 Petition From North Carolina U.S. EPA, Office of General Counsel, EPA must allow a public hearing for the Mail Code 2344A, 1200 Pennsylvania petition. In addition, EPA’s action under AGENCY: Environmental Protection Avenue, NW., Washington, DC 20460, section 126 is subject to the procedural Agency (EPA). telephone (202) 564–5582, e-mail at requirements of CAA section 307(d). See ACTION: Final rule. [email protected]. section 307(d)(1)(N). One of these requirements is notice-and-comment SUMMARY: The EPA is extending by six SUPPLEMENTARY INFORMATION: Today’s additional months the deadline for action is procedural and is set in the rulemaking, under section 307(d)(3). In addition, section 307(d)(10) taking final action on a petition context of a separate action that EPA is provides for a time extension, under submitted by the State of North Carolina taking to address the problem of certain circumstances, for rulemaking under section 126 of the Clean Air Act interstate transport of fine particulate subject to section 307(d). Specifically, (CAA). The petition requests that EPA matter and 8-hour ozone and their section 307(d)(10) provides: make findings that certain sources precursors in the eastern half of the located in 13 States are significantly United States. Each statutory deadline for promulgation contributing to fine particulate matter On January 30, 2004 (69 FR 4566), of rules to which this subsection applies and/or 8-hour ozone nonattainment or EPA proposed the ‘‘Rule to Reduce which requires promulgation less than six maintenance problems in North months after date of proposal may be Interstate Transport of Fine Particulate extended to not more than six months after Carolina. Under the CAA, EPA is Matter and Ozone (Interstate Air Quality date of proposal by the Administrator upon authorized to grant this time extension Rule),’’ now known as the Clean Air a determination that such extension is if EPA determines that the extension is Interstate Rule. This action proposes to necessary to afford the public, and the necessary, among other things, to meet require 29 States and the District of agency, adequate opportunity to carry out the the purposes of the CAA’s rulemaking Columbia to revise their State purposes of the subsection. requirements. By this document, EPA is implementation plans (SIPs) to include Section 307(d)(10) applies to section making that determination. control measures to reduce specified 126 rulemakings because the 60-day DATES: Effective Date: This action is amounts of emissions of sulfur dioxide time limit under section 126(b) effective on May 18, 2004. (SO2) and/or nitrogen oxides (NOX). necessarily limits the period after ADDRESSES: The EPA has established a The proposal is designed to assure that proposal to less than 6 months. docket for the action on North the SIPs meet the requirements of CAA In accordance with section 307(d)(10), Carolina’s section 126 petition under section 110(a)(2)(D), which mandates EPA is today determining that the 60- Docket ID No. OAR–2004–0076. All that SIPs contain adequate provisions day period afforded by section 126(b) is documents in the docket are listed in prohibiting emissions that contribute not adequate to allow the public and the the EDOCKET index at http:// significantly to nonattainment problems Agency adequate opportunity to carry www.epa.gov/edocket. Although listed in downwind States. Controlling the out the purposes of section 307(b). in the index, some information is not pollution transport will assist the Specifically, the 60-day period is not publicly available, i.e., confidential downwind States in achieving the fine sufficient for EPA to develop an business information (CBI) or other particulate matter and 8-hour ozone adequate proposal on whether the information whose disclosure is national ambient air quality standards. sources identified in the section 126 restricted by statute. Certain other On March 19, 2004, EPA received a petition contribute significantly to material, such as copyrighted material, petition from the State of North Carolina nonattainment problems downwind, is not placed on the Internet and will be filed under CAA section 126. Section and, further, to allow public input into publicly available only in hard copy 126 is related to section 110(a)(2)(D) and the promulgation of any controls to form. Publicly available docket is also designed to remedy interstate mitigate or eliminate those materials are available either pollution transport. Section 126(b) contributions. electronically in EDOCKET or in hard authorizes States or political The determination whether upwind copy at the Docket, EPA/DC, EPA West, subdivisions to petition EPA for a emissions contribute significantly to Room B102, 1301 Constitution Ave., finding that major stationary sources or downwind nonattainment areas is NW., Washington, DC. The Public groups of sources in upwind States emit highly complex. The proposed Clean Reading Room is open from 8:30 a.m. to in violation of the prohibition of section Air Interstate Rule, which proposes a 4:30 p.m., Monday through Friday, 110(a)(2)(D), by contributing somewhat comparable determination, excluding legal holidays. The telephone significantly to nonattainment problems relies on extensive computer modeling number for the Public Reading Room is in downwind States. If EPA makes such of air quality emissions and ambient (202) 566–1744, and the telephone a finding, EPA is authorized to establish impacts therefrom in the large number for the EPA Air Docket is (202) Federal emissions limits for the affected geographic region of the eastern half of 566–1742. sources. the United States. You may access this Federal Register Under section 126(b), EPA must make In action on the section 126 petition, document electronically through the the finding requested in the North EPA must make determinations that, EPA Internet under the ‘‘Federal Carolina petition, or deny the petition, generally, are at least as complex as Register’’ listings at http:// within 60 days of the March 19, 2004, those required for the Clean Air www.epa.gov/fedrgstr/. receipt of the petition. Under section Interstate Rule. Moreover, if EPA FOR FURTHER INFORMATION CONTACT: For 126(c), any existing sources for which determines that the petitions should be general information and policy EPA makes the requested finding must granted, EPA would promulgate

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appropriate controls for the affected resources from the critical substantive therefore it is not subject to the notice- sources. review of the section 126 petition. and-comment requirement. The EPA is in the process of Although this final rule is not subject C. Effective Date Under the APA determining what would be an to the RFA, EPA nonetheless has appropriate schedule for action on the Today’s action is effective on May 18, assessed the potential impact on small section 126 petition, in light of the 2004. Under the APA, 5 U.S.C.(d)(3), entities subject to the rule. Today’s rule complexity of the required agency rulemaking may take effect does not create new requirements for determinations and the usefulness of before 30 days after the date of small entities or other sources. publication in the Federal Register if coordinating generally with the D. Unfunded Mandates Reform Act procedural path for the Clean Air the agency has good cause to mandate Interstate Rule. It is imperative that this an earlier effective date. Today’s Title II of the Unfunded Mandates schedule afford EPA adequate time to action—a deadline extension—must Reform Act of 1995 (UMRA), Public prepare a proposal that clearly take effect immediately because its Law 104–4, establishes requirements for elucidates the issues so as to facilitate purpose is to extend by 6 months the Federal agencies to assess the effects of public comments, as well as to afford deadline for action on the petition. their regulatory actions on State, local, the public adequate time to comment. Moreover, EPA intends to use and tribal governments and the private The EPA is currently discussing an immediately the 6-month extension sector. Under section 202 of the UMRA, appropriate schedule with North period to continue to develop an 2 U.S.C. 1532, EPA generally must Carolina. appropriate schedule for the ultimate prepare a written statement, including a Extending the date for action on the action on the section 126 petition and cost-benefit analysis, for any proposed section 126 petition for 6 months is to continue to develop the technical or final rules with ‘‘Federal mandates’’ necessary to determine the appropriate analysis needed for the notice of that may result in the expenditure by overall schedule for action, as well as to proposed rulemaking. These reasons State, local, and tribal governments, in continue to develop the technical support an effective date prior to 30 the aggregate, or by the private sector, of analysis needed to develop a proposal. days after publication. $100 million or more in any 1 year. The EPA has determined that these II. Final Action III. Statutory and Executive Order requirements do not apply to today’s Reviews A. Rule action because today’s rulemaking is not a Federal mandate—rather, it simply Today, EPA is determining, under A. Executive Order 12866: Regulatory Planning and Review extends the date for EPA to take action CAA section 307(d)(10), that a 6-month on a petition—and it contains no period is needed to assure the Under Executive Order 12866 (58 FR regulatory requirements that might development of an appropriate schedule 51735, October 4, 1993), the Agency significantly or uniquely affect small for rulemaking on the North Carolina must determine whether the regulatory governments. section 126 petition, which schedule action is ‘‘significant’’ and, therefore, would allow EPA adequate time to subject to Office of Management and E. Executive Order 13132: Federalism prepare a notice of proposed rulemaking Budget (OMB) review and the Executive Order 13132, entitled that will best facilitate public comment, requirements of the Executive Order. ‘‘Federalism’’ (64 FR 43255, August 10, as well as allow the public sufficient The OMB has exempted this regulatory 1999), requires EPA to develop an time to comment. Accordingly, EPA is action from Executive Order 12866 accountable process to ensure granting a 6-month extension to the time review. Accordingly, Executive Order ‘‘meaningful and timely input by State for rulemaking on the North Carolina 12866 does not apply to today’s action. and local officials in the development of section 126 petition. Under this B. Paperwork Reduction Act regulatory policies that have federalism extension, the date for action on the implications.’’ ‘‘Policies that have petition is November 18, 2004. This action does not impose an federalism implications’’ is defined in information collection burden under the B. Notice-and-Comment Under the the Executive Order to include provisions of the Paperwork Reduction Administrative Procedures Act (APA) regulations that have ‘‘substantial direct Act, 44 U.S.C. 3501 et seq. Today’s rule effects on the States, on the relationship This document is a final agency does not create new requirements and is between the national government and action, but may not be subject to the not subject to the Paperwork Reduction the States, or on the distribution of notice-and-comment requirements of Act. power and responsibilities among the the APA, 5 U.S.C. 553(b). The EPA C. Regulatory Flexibility Act various levels of government.’’ believes that because of the limited time Today’s action does not have provided to make a determination that Today’s final rule is not subject to the federalism implications. It imposes no the deadline for action on the section Regulatory Flexibility Act (RFA), which regulatory burdens. Thus, the 126 petition should be extended, generally requires an agency to prepare requirements of section 6 of the Congress may not have intended such a a regulatory flexibility analysis for any Executive Order do not apply to this determination to be subject to notice- rule that will have a significant rulemaking action. and-comment rulemaking. However, to economic impact on a substantial the extent that this determination is number of small entities. The RFA F. Executive Order 13175: Consultation subject to notice-and-comment applies only to rules subject to notice- and Coordination With Indian Tribal rulemaking, EPA evokes the good cause and-comment rulemaking requirements Governments exception pursuant to the EPA, 5 U.S.C. under the APA or any other statute. This Executive Order 13175, entitled 553(b)(3)(B). Providing for notice-and- rule is not subject to notice-and- ‘‘Consultation and Coordination with comment would be impracticable comment requirements under the APA Indian Tribal Governments’’ (65 FR because of the limited time provided for or any other statute because although 67249, November 6, 2000), requires EPA making this determination, and would the rule is subject to the APA, the to develop an accountable process to be contrary to the public interest Agency has invoked the ‘‘good cause’’ ensure ‘‘meaningful and timely input by because it would divert Agency exemption under 5 U.S.C. 553(b), Tribal officials in the development of

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regulatory policies that have Tribal the regulation. This rule is not subject interest, the rule may take effect on the implications.’’ ‘‘Policies that have Tribal to Executive Order 13045 because it date set by the Agency. The EPA will implications’’ is defined in the simply extends the deadline for EPA to submit a report containing this rule and Executive Order to include regulations take action on a petition and does not other required information to the U.S. that have ‘‘substantial direct effects on impose any regulatory requirements. Senate, the U.S. House of one or more Indian Tribes, on the H. Executive Order 13211: Actions That Representatives, and the Comptroller relationship between the Federal Significantly Affect Energy Supply, General of the United States prior to government and the Indian Tribes, or on Distribution, or Use publication of the rule in the Federal the distribution of power and Register. This action is not a ‘‘major responsibilities between the Federal This rule is not subject to Executive rule’’ as defined by 5 U.S.C. 804(2). government and Indian tribes.’’ Order 13211, ‘‘Actions That K. Judicial Review This rule does not have tribal Significantly Affect Energy Supply, implications. It will not have substantial Distribution, or Use’’ (66 FR 28355, May Section 307(b)(1) of the CAA indicates direct effects on tribal governments, on 22, 2001) because it is not a significant which Federal Courts of Appeal have the relationship between the Federal regulatory action under Executive Order venue for petitions of review of final government and Indian tribes, or on the 12866. Today’s action does not establish actions by EPA. This section provides, distribution of power and any new regulatory requirements. in part, that petitions for review must be responsibilities between the Federal I. National Technology Transfer filed in the Court of Appeals for the government and Indian tribes, as Advancement Act District of Columbia Circuit (i) when the specified in Executive Order 13175. Section 12(d) of the National agency action consists of ‘‘nationally Today’s action does not significantly or Technology Transfer Advancement Act applicable regulations promulgated, or uniquely affect the communities of of 1995 (‘‘NTTAA,’’ Public Law 104–113 final actions taken, by the Indian tribal governments. As discussed section 12(d) 15 U.S.C. 272 note) directs Administrator,’’ or (ii) when such action above, today’s action imposes no new EPA to use voluntary consensus is locally or regionally applicable, if requirements that would impose standards in its regulatory activities that ‘‘such action is based on a compliance burdens. Accordingly, the establish technical standards, unless to determination of nationwide scope or requirements of Executive Order 13175 do so would be inconsistent with effect and if in taking such action the do not apply to this rule. applicable law or otherwise impractical. Administrator finds and publishes that such action is based on such a G. Executive Order 13045: Protection of The NTTAA does not apply because determination.’’ Children From Environmental Health today’s action does not establish any and Safety Risks new technical standards. Under CAA section 307(b)(1), a petition to review today’s action must J. Congressional Review Act Executive Order 13045: ‘‘Protection of be filed in the Court of Appeals for the Children from Environmental Health The Congressional Review Act (CRA), District of Columbia Circuit within 60 and Safety Risks’’ (62 FR 19885, April 5 U.S.C. 801 et seq., as added by the days of May 18, 2004. 23, 1997) applies to any rule that (1) is Small Business Regulatory Enforcement determined to be ‘‘economically Fairness Act of 1996, generally provides List of Subjects in 40 CFR Part 52 significant’’ as defined under Executive that before a rule may take effect, the Environmental protection, Air Order 12866, and (2) concerns an agency promulgating the rule must pollution control, Intergovernmental environmental health or safety risk that submit a rule report, which includes a relations, Nitrogen oxides, Ozone, EPA has reason to believe may have a copy of the rule, to each House of the Reporting and recordkeeping disproportionate effect on children. Congress and to the Comptroller General requirements. The EPA interprets Executive Order of the United States. Section 808 of the 13045 as applying only to those CRA provides an exception to this Dated: May 18, 2004. regulatory actions that are based on requirement. For any rule for which an Michael O. Leavitt, health or safety risks, such that the agency for good cause finds that notice Administrator. analysis required under section 5–501 of and comment are impracticable, [FR Doc. 04–11768 Filed 5–25–04; 8:45 am] the Order has the potential to influence unnecessary, or contrary to the public BILLING CODE 6560–50–P

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Part IV

Environmental Protection Agency 40 CFR Part 180 Imidacloprid; Order Denying Objections to Issuance of Tolerance, and Final Order Imidacloprid; Pesticide Tolerance; Final Rules

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ENVIRONMENTAL PROTECTION 4099; fax number: (703) 308–4776; e- 5. Missing exposure data—specific. AGENCY mail address: [email protected]. a. Information on regional consumption. SUPPLEMENTARY INFORMATION: 40 CFR Part 180 b. Residential exposure information. Response to NRDC Objections c. Prospective ground water [OPP–2004–0152; FRL–7355–7] monitoring studies. Table of Contents 6. Missing risk assessment. Imidacloprid; Order Denying 7. Conclusion on children’s safety factor I. General Information Objections to Issuance of Tolerance issues. A. Does this Action Apply to Me? C. LOAEL/NOAEL B. How Can I Get Additional Information, AGENCY: Environmental Protection 1. Generic legal argument. Including Copies of this Document and 2. Use of LOAELs to assess Imidacloprid Agency (EPA). Other Related Documents? risk. ACTION: Final order. 1. Electronically. D. Aggregate Exposure 2. In person. 1. Worker exposure. SUMMARY: On four occasions in the first II. Introduction 2. Classification of farm children as a half of 2002, the Natural Resource A. What Action is the Agency Taking? major identifiable population subgroup. B. What is the Agency’s Authority for Taking Defense Council (NRDC) and various 3. NRDC’s 1998 Petition on Farm this Action? other parties filed objections with EPA Children. III. Statutory and Regulatory Background to final rules under section 408 of the 4. Adequacy of EPA’s assessment of the Federal Food, Drug, and Cosmetic Act A. Statutory Background B. Assessing Risk Under the FFDCA aggregate exposure of children, including (FFDCA) establishing pesticide C. Science Policies children in agricultural areas. tolerances for various pesticides. The 1. Children’s Safety Factor Policy. 5. Residential exposure as a result of use objections apply to 14 pesticides and 2. Aggregate exposure policies. requiring a tolerance. over 70 separate pesticide tolerances. D. NRDC Farmworker Children Petition 6. Population percentile used in Although the objections raise numerous IV. NRDC Objections aggregate exposure estimates. a. In general. pesticide-specific issues, they all focus A. In General B. Generic Issues b. Choice of population percentile. on the potential risks that the pesticides 7. Lack of residential exposure pose to farm children. This order V. Public Comment A. General assessment for adults. responds to NRDC’s objections as to the B. Individual Comments 8. Percent crop treated. imidacloprid tolerance on blueberries. 1. The FQPA Implementation Working E. Lack of Emergency The objections are denied as moot Group. VIII. Response to Comments because this imidacloprid tolerance has 2. Inter-Regional Research Project A. IWG Comments expired. Because EPA is elsewhere in Number 4 (IR-4). B. Citizen Comments today’s Federal Register reestablishing 3. Bayer CropScience. C. IR-4 Comments VI. Response to Objections IX. Statutory and Executive Order Reviews the imidacloprid tolerance on X. Congressional Review Act blueberries, EPA has treated NRDC’s VII. Analysis of the Issues Raised by NRDC’s Objections XI. Time and Date of Entry of Order objections as comments on the petition A. Children’s Exposure to Pesticides in XII. References to reestablish the blueberry tolerance Agricultural Areas. I. General Information and has explained in full in this 1. Studies Focusing on exposure to document why NRDC’s objections are children in agricultural areas. A. Does this Action Apply to Me? not well taken. a. Potential for exposure due to In this document EPA denies as moot ADDRESSES: EPA has established a heightened pesticide levels in the homes of farm children. objections to a tolerance action filed by docket for this action under Docket ID b. Whether farm children actually NRDC. In addition to NRDC, this action number OPP–2004–0152 All documents experience increased exposure. will be of interest to the pesticide in the docket are listed in the EDOCKET i. Studies allowing comparison of manufacturers and pesticide registrants index at http://www.epa.gov/edocket. children from agricultural and non- whose product was the subject of the Although listed in the index, some agricultural areas. objections. Further, this action may be information is not publicly available, ii. Studies focusing solely on of interest to the following parties who children from agricultural areas. i.e., CBI or other information have filed similar objections with EPA whosedisclosure is restricted by statute. iii. Ongoing research on farm children exposures. on other pesticide tolerances: Boston Certain other material, such as c. Conclusion. Women’s Health Book Collective, Breast copyrighted material, is not placed on 2. Supplemental information regarding Cancer Action, Californians for the Internet and will be publicly spray drift and drift of volatilized Pesticide Reform, Commonweal, available only in hard copy form. residues. Lymphoma Foundation of America, Publicly available docket materials are 3. EPA data on spray drift and the spray NRDC, Northwest Coalition for available either electronically in drift model. Alternatives to Pesticides, Pesticide B. Failed to Retain Children’s 10X Safety EDOCKET or in hard copy at the Public Action Network, North America, Information and Records Integrity Factor 1. Introduction. Pineros y Campesinos Unidos del Branch (PIRIB), Rm. 119, Crystal Mall 2. EPA’s children safety factor decision. Noroeste, SF-Bay Area Chapter of #2, 1921 Jefferson Davis Hwy., a. In general. Physicians for Social Responsibility, Arlington, VA., Monday through Friday, b. Imidacloprid. and Women’s Cancer Resource Center. excluding legal holidays. The Docket 3. Missing Toxicity Data—Lack of DNT. Finally, this action may be of interest to telephone number is (703) 305–5805. 4. Missing Exposure Data—General. agricultural producers, food FOR FURTHER INFORMATION CONTACT: a. Farm children exposure. manufacturers, or other pesticide William Jordan, Office of Pesticide b. Lack of comprehensive DW monitoring data. manufacturers. Potentially affected Programs, 7506C, Environmental i. Models and data. categories and entities may include, but Protection Agency, 1200 Pennsylvania ii. EPA’s drinking water models. are not limited to: Ave., NW., Washington, DC 20460– iii. Imidacloprid-specific data. • Industry, e.g., NAICS 111, 112, 0001; telephone number: (703) 308– iv. Conclusion. 311, 32532, Crop production, Animal

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production, Food manufacturing, NRDC did not exercise the option theobjections to the imidacloprid Pesticide manufacturing. provided in section 408(h) of FFDCA to tolerance as moot. Finally, EPA’s This listing is not intended to be request a hearing on its objections, but detailed response to the issues raised by exhaustive, but rather provides a guide instead asked that the Agency rule on its the objections on the imidacloprid for readers regarding entities who may objections on the basis of its written tolerance is included as a part of its be interested in this action. objections and attached submissions. action in granting a permanent tolerance Because the objections raised questions for imidacloprid on blueberries. B. How Can I Get Additional of broad interest, EPA published a Information, Including Copies of this representative copy of the objections in B. What is the Agency’s Authority for Document and Other Related the Federal Register for comment, (67 Taking this Action? Documents? FR 41628) (June 19, 2002) (FRL–7167– The procedure for filing objections to 1. Electronically. You may obtain 7), and made all of the objections tolerance actions and EPA’s authority electronic copies of this document, and available for public review on its for acting on such objections is certain other related documents that website. This order responds to NRDC’s contained in section 408(g) of FFDCA might be available electronically, from objections as to the imidacloprid and regulations at 40 CFR part 178. 21 the EPA Internet Home Page at http:// tolerance on blueberries. U.S.C. 346a(g). www.epa.gov/. To access this document, EPA had planned to respond to the III. Statutory and Regulatory on the Home Page select ‘‘Laws and four sets of objections in a single order. Background Regulations,’’ ‘‘Regulations and That plan has been superceded by the Proposed Rules,’’ and then look up the December 31, 2003, expiration of the A. Statutory Background objected-to imidacloprid tolerance on entry for this document under the EPA establishes maximum residue blueberries, the demonstrable Federal Register—Environmental limits, or ‘‘tolerances,’’ for pesticide agricultural need for continuation of use Documents. You can also go directly to residues in food under section 408 of of imidacloprid on blueberries, and the Federal Register listings at http:// FFDCA. 21 U.S.C. 346a. Without such a NRDC’s submission in June, 2003 of www.epa.gov/fedrgstr/. tolerance or an exemption from the significant supplemental information on 2. In person. The Agency has opened requirement of a tolerance, a food a docket for this action under docket ID its objections. Technically, NRDC’s objections to the imidacloprid tolerance containing a pesticide residue is number OPP–2002–0057. Included in ‘‘adulterated’’ under section 402 of the docket are EPA documents on blueberries have become moot due to the expiration of the tolerance and this FFDCA and may not be legally moved specifically referenced in this action, in interstate commerce. 21 U.S.C. 331, any public comments received during order denies them on that ground. Nonetheless, due to the fact that 342. Monitoring and enforcement of an applicable comment period, and pesticide tolerances are carried out by other information submitted by NRDC. elsewhere in today’s Federal Register EPA is re-establishing an imidacloprid the U.S. Food and Drug Administration The docket does not include any (FDA) and the U. S. Department of information claimed as CBI. The docket tolerance on blueberries, EPA has treated the objections as a comment on Agriculture (USDA). is available for inspection in the Public A pesticide tolerance may only be Information and Records Integrity the petition to re-establish the imidacloprid tolerance and is issuing in promulgated by EPA if the tolerance is Branch (PIRIB), Rm. 119, Crystal Mall ‘‘safe.’’ 21 U.S.C. 346a(b)(2)(A)(i). ‘‘Safe’’ #2, 1921 Jefferson Davis Hwy., this denial order its planned response to the objections as a response to is defined by the statute to mean that Arlington, VA, from 8:30 a.m. to 4 p.m., ‘‘there is a reasonable certainty that no Monday through Friday, excluding legal comments on the proposed establishment of the imidacloprid harm will result from aggregate holidays. The PIRIB telephone number exposure to the pesticide chemical is (703) 305–5805. tolerance. If NRDC files the same objections to the re-established residue, including all anticipated II. Introduction imidacloprid tolerance, EPA will re- dietary exposures and all other exposures for which there is reliable A. What Action is the Agency Taking? issue this comment response as a response to NRDC’s objection forthwith. information.’’ 21 U.S.C. On four occasions in the first half of EPA cannot issue its response to all four 346a(b)(2)(A)(ii). Section 408 of FFDCA 2002, NRDC and various other parties sets of NRDC’s objections at this time directs EPA, in making a safety filed objections with EPA to final rules because EPA has not completed determination, to ‘‘consider, among under section 408 of FFDCA, 21 U.S.C. reviewing supplemental information on other relevant factors . . .available 346a, establishing pesticide tolerances the objections submitted by NRDC in information concerning the aggregate for various pesticides. The objections June, 2003. As to imidacloprid, exposure levels of consumers (and apply to 14 pesticides and over 70 however, specific facts relating to that major identifiable subgroups of separate pesticide tolerances. Although pesticide allow EPA to address all of the consumers) to the pesticide chemical the objections raise numerous pesticide- issues raised by the objections to that residue and to other related substances, specific issues, they all focus on the tolerance. including dietary exposure under the potential risks that the pesticides pose The body of this document contains tolerance and all other tolerances in to farm children. Further each of the the following sections. First, there is a effect for the pesticide chemical residue, objections makes two main assertions background section which explains the and exposure from other non- with regard to the pesticide tolerances applicable statutory and regulatory occupational sources.’’ 21 U.S.C. in question: provisions, the relevant EPA science 346a(b)(2)(D)(vi). Other provisions 1. That EPA has not properly applied policy documents, and prior NRDC address in greater detail exposure the additional 10X safety factor for the actions with regard to farm children. considerations involving ‘‘anticipated protection of infants and children in Second, there is a section setting forth and actual residue levels’’ and ‘‘percent section 408(b)(2)(C) of FFDCA. in greater detail the substance of the of crop actually treated.’’ See 21 U.S.C. 2. That EPA has not accurately objections. Third, a summary of the 346a(b)(2)(E) and (F). Section assessed the aggregate exposure of farm public comment is presented. Fourth, 408(b)(2)(C) of FFDCA requires EPA to children to pesticide residues. there is a section which denies give special consideration to risks posed

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to infants and children. This provision in FIFRA registration actions as to For non-dietary, and combined directs that ‘‘an additional tenfold pesticide uses which result in dietary dietary and non-dietary, risk margin of safety for the pesticide risk from residues in or on food, 7 assessments (other than cancer), the chemical residue and other sources of U.S.C. 136(bb), and directing that EPA same safety factors are used to exposure shall be applied for infants coordinate, to the extent practicable, determine the toxicological level of and children to take into account revocations of tolerances with pesticide concern. For example, when 1,000 is the potential pre- and post-natal toxicity cancellations under FIFRA. 21 U.S.C. appropriate safety factor (10X to account and completeness of the data with 346a(l)(1). for interspecies differences, 10X for respect to exposure and toxicity to intraspecies differences, and 10X for infants and children.’’ 21 U.S.C. B. Assessing Risk Under the FFDCA FQPA), the level of concern is that there 346a(b)(2)(C). EPA is permitted to ‘‘use In assessing and quantifying non- be a 1,000-fold margin between the a different margin of safety for the cancer risks posed by pesticides under NOAEL from the toxicology study pesticide chemical residue only if, on the FFDCA as amended by the FQPA, identified as appropriate for use in risk the basis of reliable data, such margin EPA first determines the toxicological assessment and human exposure. To will be safe for infants and children.’’ level of concern and then compares estimate risk, a ratio of the NOAEL to Id. [The additional safety margin for estimated human exposure to this level aggregate exposures (MOE = NOAEL/ infants and children is referred to of concern. This comparison is done exposure) is calculated and compared to throughout this notice as the ‘‘children’s through either calculating a safe dose in the level of concern. In contrast, to the safety factor.’’] These provisions humans (incorporating all appropriate RfD approach, the higher the MOE, the establishing the detailed safety standard safety factors) and expressing exposure safer the pesticide. Accordingly, if the for pesticides were added to section 408 as a percentage of this safe dose (the level of concern for a pesticide is 1,000, of FFDCA by the Food Quality reference dose (RfD) approach) or MOE’s exceeding 1,000 would generally Protection Act of 1996 (FQPA), an Act dividing estimated human exposure into not be of concern. that substantially rewrote this section of the lowest dose at which no adverse For cancer risk assessments, EPA the statute. effects from the pesticide are seen in generally assumes that any amount of Tolerances are established by relevant studies (the margin of exposure exposure will lead to some degree of rulemaking under the unique (MOE) approach). How EPA determines cancer risk. Using a model based on the procedural framework set forth in the level of concern, chooses safety slope of the cancer dose-response curve FFDCA. Generally, the rulemaking is factors, and estimates risk under these in relevant studies, EPA estimates risk initiated by the party seeking the two approaches is explained in more in terms of the probability of occurrence tolerance by means of filing a petition detail below. of additional cancer cases as a result of with EPA. See 21 U.S.C. 346a(d)(1). EPA exposure to the pesticide. An example publishes in the Federal Register a For dietary risk assessment (other of how such a probability risk is notice of the petition filing along with than cancer), the dose at which no expressed would be to describe the risk a summary of the petition, prepared by adverse effects are observed (the as one in one hundred thousand (1 X the petitioner. 21 U.S.C. 346a(d)(3). NOAEL) from the toxicology study 10-5), one in a million (1 X 10-6), or one After reviewing the petition, and any identified as appropriate for use in risk in ten million (1 X 10-7). Under certain comments received on it, EPA may issue assessment is used to estimate the specific circumstances, MOE a final rule establishing the tolerance, toxicological level of concern. However, calculations will be used for the issue a proposed rule, or deny the the lowest dose at which adverse effects carcinogenic risk assessment. No further petition. 21 U.S.C. 346a(d)(4). Once EPA of concern are identified (the LOAEL) is discussion of cancer risk assessment is takes final action on the petition by sometimes used for risk assessment if no included because imidacloprid has not either establishing the tolerance or NOAEL was achieved in the toxicology been identified as posing a cancer risk. denying the petition, any affected party study selected. A safety or uncertainty C. Science Policies has 60 days to file objections with EPA factor is then applied to this and seek an evidentiary hearing on toxicological level of concern to As part of implementation of the those objections. 21 U.S.C. 346a(g)(2). calculate a safe dose for humans, major changes to section 408 of FFDCA EPA’s final order on the objections is usually referred to by EPA as an acute included in FQPA, EPA has issued a subject to judicial review. 21 U.S.C. or chronic reference dose (acute RfD or number of policy guidance documents 346a(h)(1). chronic RfD). The RfD is equal to the addressing critical science issues. Of EPA also regulates pesticides under NOAEL divided by all applicable safety particular interest to the NRDC FIFRA, 7 U.S.C. 136 et seq. While the or uncertainty factors. Typically, a objections are the science policies FFDCA authorizes the establishment of safety or uncertainty factor of 100 is covering the children’s safety factor, legal limits for pesticide residues in used, 10X to account for uncertainties aggregate pesticide exposure, and the food, FIFRA requires the approval of inherent in the extrapolation from population percentile of exposureused pesticides prior to their sale and laboratory animal data to humans and in estimating aggregate exposure. distribution, 7 U.S.C. 136a(a), and 10X for variations in sensitivity among 1. Children’s Safety Factor Policy. On establishes a registration regime for members of the human population as January 31, 2002, EPA released its regulating the use of pesticides. FIFRA well as other unknowns. Further, under science policy guidance on the regulates pesticide use in conjunction the FQPA, an additional safety factor of children’s safety factor. (Ref. 48), with its registration scheme by requiring 10X is presumptively applied to protect [hereinafter referred to in the text as the EPA review and approval of pesticide infants and children, unless reliable ‘‘Children’s Safety Factor Policy’’]. That labels and specifying that use of a data support selection of a different policy had undergone an intensive and pesticide inconsistent with its label is a factor. To quantitatively describe risk extended process of public comment as violation of federal law. 7 U.S.C. using the RfD approach, estimated well as internal and external science 136j(a)(2)(G). In the FQPA, Congress exposure is expressed as a percentage of peer review. An EPA-wide task force integrated action under the two statutes the RfD. Dietary exposures lower than was established to consider the by requiring that the safety standard 100% of the RfD are generally not of children’s safety factor in March 1998. under the FFDCA be used as a criterion concern. Taking into account reports issued by

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the task force on both toxicity and affect calculation of a safe exposure that are critical for assessing the risks to exposure issues, EPA’s OPP released a level (commonly referred to as the infants and children.’’ Id. at 32. EPA draft children’s safety policy document Reference Dose (RfD)). Id. at 22; see 67 described why its methods for in May 1999. That document was FR 60950, 60955 (Sept. 27, 2002) calculating exposure through various subject to an extended public comment (finding no additional safety factor routes and aggregating exposure over period as well as review by the FIFRA necessary for triticonazole despite lack those routes generally produce Scientific Advisory Panel. Id. at 5. of developmental neurotoxicity (DNT) conservative exposure estimates—i.e. The Children’s Safety Factor Policy study because the ‘‘DNT is unlikely to health-protective estimates due to emphasizes throughout that EPA affect the manner in which triticonazole overestimation of exposure. Id. at 40-43. interprets the children’s safety factor is regulated.’’). When the missing data Nonetheless, EPA emphasized the provision as establishing a presumption are data above and beyond general importance of verifying that the in favor of application of an additional regulatory requirements, EPA indicated tendency for its methods to overestimate 10X safety factor for the protection of that the weight of evidence would exposure in fact were adequately infants and children. Id. at 4, 11, 47, A- generally only support the need for an protective in each individual 6. Further, EPA notes that the children’s additional safety factor where the data assessment. Id. at 44. safety factor provision permits a ‘‘is being required for ‘cause,’ that is, if 2. Aggregate exposure policies. As different safety factor to be substituted a significant concern is raised based mentioned above, the FQPA-added for this default 10X factor only if upon a review of existing information, safety standard directs that the safety of reliable data are available to show that not simply because a data requirement pesticide residues in food be based on the different factor will protect the has been levied to expand OPP’s general ‘‘aggregate exposure’’ to the pesticide. safety of infants and children. Id. Given knowledge.’’ (Ref 48 at 23). Finally, with 21 U.S.C. 346a(b)(2)(A)(ii). Aggregate the wealth of data available on regard to the developmental exposure to a pesticide includes all pesticides, however, EPA indicated a neurotoxicity study (DNT), EPA listed ‘‘anticipated dietary exposure and all preference for making an individualized several important factors addressing the other exposures for which there is determination of a protective safety weight of evidence bearing on the reliable information.’’ Id. The statute factor if possible. Id. at 11. EPA stated degree of concern when such a study makes clear that in assessing aggregate that use of the default factor could has been required but has not yet been exposure pertaining to a pesticide EPA under- or over-protect infants and completed. Id. at 24. Moreover, EPA must consider not only exposure to the children due to the wide variety of reiterated that, like any other missing pesticide in the food covered by the issues addressed by the children’s safety study, the absence of the DNT does not tolerance in question but exposure to factor. Id. EPA noted that ‘‘[i]ndividual trigger a mandatory requirement to the pesticide as a result of other assessments may result in the use of retain the default 10X value, but rather tolerances and from ‘‘other non- additional factors greater or less than, or depends on an individualized occupational sources.’’ Id. Section equal to 10X, or no additional factor at assessment centering on the question of 346a(b)(2)(D)(vi). Further, the statute all.’’ Id. Because EPA thought that whether ‘‘a DNT study is likely to directs EPA to consider aggregate individualized assessments would be identify a new hazard or effects at lower exposure to other substances related to able to be made in most cases, EPA dose levels of the pesticide that could the pesticide so long as that exposure indicated that ‘‘this guidance document significantly change the outcome of its results from a non-occupational source. focuses primarily on the considerations risk assessment . . . ’’ Id. Id. Section 346a(b)(2)(D)(vi). In relevant to determining a safety factor As to potential pre- and post-natal November 2001, EPA released a science ‘different’ from the default 10X that toxicity, the Children’s Safety Factor guidance document entitled General protects infants and children. Policy lists a variety of factors that Principles for Performing Aggregate Discussions in this document of the should be considered in evaluating the Exposure and Risk Assessments. This appropriateness, adequacy, need for, or degree of concern regarding any document deals primarily with the size of an additional safety factor are identified pre- or post-natal toxicity. Id. complex subject of integrating premised on the fact that reliable data at 27-31. As with the completeness of distributional and probabilistic exist for choosing a ‘different’ factor the toxicity database, EPA emphasized techniques into aggregate exposure than the 10X default value.’’ Id. at 12. that the analysis should focus on analyses. (Ref. 49). In making such individual whether any identified pre- or post-natal More relevant to the current assessments regarding the magnitude of toxicity raises uncertainty as to whether objections, is the science guidance the safety factor, EPA stressed the the RfD is protective of infants and document issued in March 2000 importance of focusing on the statutory children. Id. at 31. Once again, the addressing the population percentile of language that ties the children’s safety presence of pre- or post-natal toxicity, exposure used in making acute exposure factor to concerns regarding potential by itself, was not regarded as estimates for applying the safety pre- and post-natal toxicity and the determinative as to the children’s safety standard under section 408 of FFDCA. completeness of the toxicity and factor. Rather, EPA stressed the (Ref. 52). Traditionally, EPA had used exposure databases. Id. at 11-12. As to importance of evaluating all of the data the 95th percentile of exposure in acute the completeness of the toxicity under a weight of evidence approach dietary exposure assessments as database, EPA recommended use of a focusing on the safety of infants and representing a reasonable worst case weight of the evidence approach which children. Id. scenario. Id. at 15. Due to the very considered not only the presence or In evaluating the completeness of the conservative (health-protective) absence of data generally required under exposure database, EPA explained that assumptions used for acute exposure EPA regulations and guidelines but also a weight of the evidence approach assessments, the 95th percentile was the availability of ‘‘any other data should be used to determine the viewed as a reasonable approximation needed to evaluate potential risks to confidence level EPA has as to whether of an exposure level not likely to be children.’’ Id. at 20. EPA indicated that the exposure assessment ‘‘is either exceeded by any individuals. Id. at 15- the principal inquiry concerning highly accurate or based upon 17. Generally, such an approach missing data would center on whether sufficiently conservative input that it assumes that all crops for which there the missing data would significantly does not underestimate those exposures is a tolerance are treated with the

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pesticide and all treated crops have are a major identifiable subgroup and NIOSH, and the National Institute of residues at the highest level legally must be protected under FQPA when Environmental Health and Safety are permitted. setting allowable levels of pesticide conducting a long-term epidemiology More recently, because of the residue in food.’’ (Ref. 36 at 2). The study of 90,000 certified pesticide availability of better data on residue Petition claims that ‘‘[a]n increasing applicators and their families in North values and new risk assessment body of scientific evidence, including Carolina and Iowa. The study is looking techniques, EPA has restructured its biomonitoring data and residential at both cancer and non-cancer approach to the use of population exposure studies, indicates that farm endpoints using periodic surveys of the exposure percentiles in making safety children face particularly significant population. Pesticide use practices and determinations for acute risks under exposures and health risks from health outcomes are being examined in section 408 of FFDCA. (Ref. 52). EPA pesticides.’’ Id. at 3. In addition to detail. Additionally, scientists are has retained the 95th percentile as the requesting the ‘‘major identifiable conducting other studies on this cohort starting point of analysis for worst case subgroup’’ designation, the Petition also to learn further about exposures and (tolerance level) assessments. EPA, asked that EPA use the children’s safety potential effects, including birth defects, however, generally uses higher factor to protect farm children, require Parkinson’s disease, asthma, and other percentiles of exposure when less additional exposure data on farm disease endpoints. As part of the conservative assumptions are made children exposure and not issue any Agricultural Health Study, field work in concerning residue values. Id. For new tolerances until such data are Iowa is being conducted, and over the example, beginning in the late 1990’s, available, deny registration for any next three years detailed exposure EPA has increasingly relied upon pesticide without a validated method analyses on a sub-sample of families probabilistic assessment techniques for for detecting residues in food, increase using various agricultural pesticides assessing acute dietary exposure and research into issues concerning farm will be completed. Some initial results risk. Because EPA generally uses much children exposure to pesticides, and have already been published for high more realistic exposure values (e.g., honor the President’s Executive order exposure events and effects to the eye. monitoring data on pesticide levels in on Environmental Justice. A detailed listing of these studies and a food) in conducting probabilistic Although EPA prior to this action has number of publications already assessments, a higher population not issued a formal response to the reporting the results of the Agricultural exposure percentile was generally found petition, it has undertaken numerous Health Study can be found at http:// to be necessary to ensure that exposure steps to ensure that it is adequately www.aghealth.org/. for the overall population was not protecting farm children including both The Agency is also pursuing several understated. The Percentile Policy initiating data gathering on exposure of other research efforts likely to provide explains and defends EPA’s choice of children in agricultural areas to additional information about any the 99.9th percentile as a starting point pesticides and programs to enhance pesticide exposure to farmworkers and for evaluating exposure and acute risk compliance with label directions their children: with probabilistic assessments. designed to minimize any bystander National Human Exposure EPA confirmed in the Percentile exposures to pesticides that could Assessment Survey (NHEXAS). EPA Policy document that it would generally occur. Data gathering activities include developed this survey in the early 1990s continue to use the 95th percentile of EPA participation in the following to provide critical information about exposure for deterministic acute risk studies: multi-pathway, multi-media population assessments that used worst case National Agricultural Workers Survey exposure distribution to chemicals. The exposure assumptions. Id. at 17, 29. The (NAWS). EPA and the National Institute data have been collected and the conservative (health-protective) nature for Occupational Safety and Health database is now being compiled. EPA of this approach was confirmed by data (NIOSH) are currently providing expects to have the information EPA cited showing that deterministic funding for the NAWS, an ongoing effort accessible on the Internet later this year. assessments of exposure at the 95th by the Department of Labor. The NAWS Children’s total exposure to persistent percentile assuming residues at is the only national information source pollutants. This study, conducted by tolerance levels regularly result in on the working and living conditions of EPA, will add to our understanding of exposure predictions significantly U.S. farmworkers and their families. any pesticide exposures to farmworker higher than probabilistic exposure EPA is working with the Department of families. The data collection for this estimates of the 99.9th percentile using Labor in analyzing over 20,000 study, initiated this year, should be monitoring data. Id. at 16-17. interviews since the survey’s onset to completed and available in 2004. Importantly, EPA’s Percentile Policy look at farm worker experiences over In terms of actions taken to enhance makes clear that in choosing a time. The interviews include questions protections to children so as to avoid population percentile to estimate concerning the following: bystander-type exposures, EPA has exposure, EPA is not intending to define Demographics, farmworkers’ job numerous programs and materials the portion of the population that is to mobility, day care arrangements, access focusing upon pesticide safety issues for be protected. The policy explicitly states to medical care, participation in farm workers and their families both at that: ‘‘OPP’s goal is to regulate pesticide training, exposures to the national and regional level. A brief pesticides in such a manner that pesticides, and reports of pesticide overview of EPA’s approaches will be everyone is reasonably certain to illness. Results from this survey, along discussed here. However, more experience no harm as a result of dietary with other studies, will assist EPA in information about EPA’s farm worker and other non-occupational exposures addressing issues of pesticide exposures efforts across its regional offices can be to pesticides.’’ Id. at 28. to farmworkers and any secondary found in the docket for this action. exposures to their families. Additional An overview of what EPA is doing on D. NRDC Farmworker Children Petition information on the NAWS survey can be the national level includes an On October 22, 1998, NRDC and 58 found at http:// www.dol.gov/asp/ assessment of the EPA’s 1992 Worker other public interest organizations and programs/agworker/naws.htm. Protection Standard (WPS). See 40 CFR individuals submitted a petition to EPA Agricultural health study. The part 170. The Worker Protection asking that EPA ‘‘find that farm children National Cancer Institute (NCI), EPA, Standard is a regulation intended to

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help reduce the risk of pesticide safety training for children at childcare Farmworker Health and funded through poisonings and injuries among centers, schools, churches, and an interagency agreement between EPA agricultural workers and handlers of community centers, and has developed and HHS Migrant Health Program. This agricultural pesticides. The WPS offers a handbook in Spanish. Also, through video is available through NCEPI and protections to over three and a half EPA funding, AFOP has developed the National Center for Farmworker million people who work with radio programs targeted at preventing Health. pesticides at over 560,000 workplaces. pesticide poisonings of children. Another video, entitled The Playing The WPS contains requirements for Also on the national level, EPA has Field is a bilingual pesticide safety pesticide safety training, notification of initiated a program with the Migrant training video for farmworker families. pesticide applications, use of personal Head Start Program (MHS) to develop Through a story about a girl poisoned by protective equipment, restricted entry materials and training for MHS on playing in a treated field, the video intervals following pesticide pesticide safety for migrant families teaches farmworkers and farmworker application, decontamination supplies, with specific attention to protecting children about the dangers of pesticides and emergency medical assistance. The children from pesticides. MHS is and how to protect themselves from national overview of implementation designed to provide comprehensive pesticides. The video was developed by and enforcement of WPS programs has Head Start services and programming to the National Center for Farmworker been completed and recommendations migrant families and their children. A Health and funded through an are being compiled. The national total of 25 grantees and 41 delegate interagency agreement between EPA assessment of WPS was a collaborative agencies provide services in 33 States and the HHS Migrant Health Program. effort of EPA, the USDA, the and serve over 30,000 migrant children, The video is available through the Department of Labor, the Department of and 25,000 children of seasonal National Center for Farmworker Health. Health and Human Services (HHS), workers, ranging in age from birth to 5 Finally, EPA’s regional offices have States, farm workers, and farmers. The years. The MHS program has a unique performed, and are performing, a reassessment effort included a great emphasis on serving infants and number of outreach activities. These amount of stakeholder input, and has toddlers as well as pre-school age activities can be divided into three led to the development of a variety of children, so they will not have to be general categories: Direct outreach; pilot programs intended to improve the cared for in the fields, or left in the care partnerships, where the Agency Agency’s outreach to farm workers. of very young siblings while parents are provides funding and/or technical Other examples of activities working. MHS also teams with assistance, and research. Examples of conducted at the national level include Americorps to provide refresher training EPA’s activities on pesticide safety for the Agency’s cooperative agreement on pesticide safety. farm workers and their families can with the Association of Farm Worker EPA on a national level, has also been befound in EPA’s docket. Opportunity Programs (AFOP) through involved in the development of two which EPA funds the National Pesticide videos on pesticide safety for IV. NRDC Objections Safety Education Program for farmworkers and their families. The A. In General agricultural workers and farm worker video, ‘‘Chasing the Sun/Siguiendo El children. Working with Americorps Sol,’’ is a bilingual farmworker pesticide During the first half of 2002, NRDC members, AFOP trains 25,000 farm safety training video designed to comply submitted four separate sets of workers and farm worker children every with the agricultural worker training objections on various pesticide year about pesticide safety using requirements mandated under the tolerances. The dates of the objections Americorps members in over 50 sites in Worker Protection Standard. It was and the pesticides involved are captured 16 states. AFOP conducts pesticide developed by the National Center for in Table 1 of this unit.

TABLE 1.—OBJECTIONS SUBMITTED

Date submitted Pesticides involved FR citations (respectively)

February 25, 2002 Halosulfuron-methyl, pymetrozine 66 FR 66,333 (December 26, 2001); 66 FR 66,778 (December 27, 2002); 66 FR 66,786 (December 27, 2001)

March 19, 2002 Imidacloprid, mepiquat, bifenazate, 67 FR 2580 (January 18, 2002); 67 FR 3113 (January, 23, 2002); 67 FR zeta-cypermethrin, diflubenzuron 4913 (February 1, 2002); 67 FR 6422 (February 12, 2002); 67 FR 7085 (February 15, 2002)

May 7, 2002 2,4-D 67 FR 10622 (March 8, 2002)

May 20, 2002 Isoxadifen-ethyl, acetamiprid, 67 FR 12,875 (March 20, 2002); 67 FR 14,649 (March 27, 2002); 67 FR propiconazole, furilazole, 14,866 (March 28, 2002); 67 FR 15,727 (April 3, 2002); 67 FR 19,114 fenhexamid, fluazinam (April 18, 2002); 67 FR 19,120 (April 18, 2002)

See Objections to the Establishment of Bifenazate, Zeta-cypermethrin, and Establishment of Tolerances for Tolerances for Pesticide Chemical Diflubenzuron Tolerances (filed March Pesticide Chemical Residues: Residues: Halosulfuron-methyl and 19, 2002) [hereinafter cited as Isoxadifen-ethyl, Acetamiprid, Pymetrozine Tolerances (filed February Imidacloprid et al. Objections], Propiconazole, Furilazole, Fenhexamid, 25, 2002) [hereinafter cited as Objections to the Establishment of and Fluazinam Tolerances (filed May Halosulfuron-methyl Objections]; Tolerances for Pesticide Chemical 20, 2002) [hereinafter cited as Objections to the Establishment of Residues: 2,4-D Tolerances (filed May 7, Isoxadifen-ethyl et al. Objections]. Tolerances for Pesticide Chemical 2002) [hereinafter cited as 2,4-D NRDC was joined in the objections Residues: Imidacloprid, Mepiquat, Objections]; Objections to the concerning 2,4-D by the following

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public interest and/or advocacy of infants and children, including determined safety relying on a LOAEL. organizations: Boston Women’s Health exposure to children living on farms In this regard, it asserts that EPA used Book Collective, Breast Cancer Action, and who accompany their parents into a LOAEL in making a safety finding for Californians for Pesticide Reform, farm fields [], and exposure from spray acute and chronic toxicity for Commonweal, Lymphoma Foundation drift.’’ Isoxadifen-ethyl et al. Objections imidacloprid. Imidacloprid et al. of America, Northwest Coalition for at 5. Fourth, NRDC asserts that EPA is Objections at 18. Alternatives to Pesticides, Pesticide missing a prospective groundwater 4. Other issues. NRDC claims that the Action Network North America, Pineros study on imidacloprid and a short-term EPA failed to comply with the statutory y Campesinos Unidos del Noroeste, SF- residential risk assessment. requirements pertaining to the use of Bay Area Chapter of Physicians for Imidacloprid Objections at 5. Finally, percent crop treated for chronic risk Social Responsibility, and Women’s NRDC argues that EPA lacks data on assessments with regard to the Cancer Resource Center. regional blueberry consumption and imidacloprid blueberry tolerance. NRDC This order responds to the objections thus has potentially underestimated asserts that the use of national percent filed on March 19, 2002, but only to the exposure in blueberry-producing states. crop treated data cannot provide a valid extent those objections apply to the 2. Aggregate exposure issues. NRDC basis for estimating exposure in pesticide imidacloprid and the tolerance raises several issues relating to whether Michigan and New Jersey, and, in fact, for imidacloprid on blueberries. EPA properly estimated ‘‘aggregate is likely to understate exposure in those exposure’’ for imidacloprid. First, NRDC B. Generic Issues states. Further, NRDC argues that EPA argues that farm children are a ‘‘major erred by relying on national NRDC raises a myriad of claims in its identifiable subgroup’’ and that EPA has consumption data instead of regional objections to the imidacloprid tolerance. failed ‘‘to consider information data from New Jersey and Michigan in Most of these claims fall fairly neatly concerning the sensitivities and estimating the risk posed by into three categories: exposures of farm children as a major imidacloprid. Finally, NRDC, in • Children’s safety factor issues. identifiable subgroup’’ in conducting its • comments it filed on its objections, Aggregate exposure issues. aggregate exposure assessment. • Issues regarding use of findings claims that the emergency exemption According to NRDC, farm children have approved under FIFRA authorizing the from hazard studies in calculating safe unique exposures to pesticides ‘‘from exposure levels— the ‘‘no observed use of imidacloprid on blueberries in their parents’ clothing, dust tracked into Michigan did not meet the standard in effect level’’ (NOEL) versus ‘‘no their homes, contaminated soil in areas observed adverse effect level’’ (NOAEL) 40 CFR 166.3(d) for the granting of such where they play, food eaten directly exemptions. and the ‘‘lowest observed adverse effect from the fields, drift from aerial level’’ (LOAEL) questions. spraying, contaminated well water, and V. Public Comment In describing these objections, citation breast milk.’’ Imidacloprid et al. A. General is made generally to the objections filed Objections at 12. Further, NRDC asserts on the imidacloprid tolerance; however, farm children’s exposure is increased On June 19, 2002, EPA published a one of the other sets of objections is because they ‘‘often accompany their notice in the Federal Register calling referenced if it provides further parents to work in the fields . . . .’’ Id. attention to and requesting comments clarification. NRDC cites various studies collected in on the Halosulfuron-methyl et al. 1. Children’s safety factor issues. For its Farm Children Petition as well as Objections, Imidacloprid et al. imidacloprid, EPA decided to use an more recent studies in support of these Objections, and the 2,4-D Objections. 67 additional safety factor for the claims. Imidacloprid et al. Objections at FR 41628 (June 19, 2002). As part of that protection of infants and children that is 12–13. Second, NRDC argues that EPA’s notice, EPA published the full text of different from the default 10X value. aggregate exposure assessment is flawed the Imidacloprid et al. Objections in the NRDC claims that EPA erred in doing so for these pesticides because EPA did not Federal Register. A period of 60 days due to the ‘‘significant toxicity and consider the added exposure to was initially allowed for comment but exposure data gaps’’ corresponding to pesticides that farmworkers receive as a that period was extended twice and was the tolerance established. See, e.g., result of their occupation. Id. at 14. closed on October 16, 2002. See 67 FR Imidacloprid et al. Objections at 3. NRDC states that EPA’s interpretation of 58536 (September 17, 2003); 67 FR Three types of data gaps are cited by the statute as excluding occupational 53505 (August 16, 2002). In addition to NRDC. First, NRDC notes that EPA has exposure is incorrect. Id. Third, NRDC a large number of form letters required a developmental neurotoxicity argues that for imidacloprid, EPA has, (principally supporting the objections) study but such study has not yet been in effect, underestimated aggregate and the NRDC’s comments mentioned submitted. Pointing to various EPA exposure by using the 95th population in Unit V.B., EPA received roughly 20 documents recommending that this percentile of exposure instead of the sets of substantive comments. These study be widely required and EPA’s 99.9th percentile in determining comments were for the most part from specific finding that this study is whether exposure to the pesticide meets pesticide manufacturers and each required as to imidicloprid, NRDC the safety standard. Imidacloprid et al. requested denial of the objections. The argues that use of a factor different than Objections at 19. NRDC claims that this most significant of these comments that 10X is precluded. Second, NRDC claims is inconsistent with existing Agency pertain to imidacloprid are summarized EPA lacks ‘‘pesticide-specific data on policy. Id. in Unit V.B. EPA has not repeated water-based exposure’’ on imidacloprid. 3. Reliance on LOAELs and NOAELs. comments in instances where they were See, e.g., Imidacloprid et al. Objections NRDC asserts that, in the absence of made by more than one commenter. at 6. NRDC argues that exposure identifying a NOEL in relevant animal estimates EPA calculated through the studies, EPA cannot make a safety B. Individual Comments use of models cannot qualify as the finding under section 408(b)(2)of 1. The FQPA Implementation Working ‘‘reliable data’’ needed to vary from the FFDCA. In support of this argument, Group. Extensive comments were filed default 10X value. Id. Third, NRDC NRDC cites to legislative history using by the FQPA Implementation Working claims that ‘‘EPA failed to consider the term NOEL. NRDC calls particular Group (IWG), an organization comprised important exposure routes for millions attention to the instances where EPA of associations representing pesticide

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manufacturers, growers, and food exposures in making safety that relied on retrospective self- processors. (Ref. 21). The IWG determinations under section 408. reporting regarding use of pesticides.’’ comments provided two alternative Not resting on these legal arguments, Id. The IWG presented preliminary data approaches as to why the NRDC’s the IWG provided detailed comments on from a study funded by pesticide and objections should be denied. First, the several other of the claims in the NRDC chemical companies and associations. IWG asserted that EPA has objections, including the following: According to the IWG, the results of this misinterpreted the concept of ‘‘aggregate a. Drinking water exposure models. study showed that ‘‘urinary exposure’’ ever since passage of the Noting that NRDC claims that EPA’s concentration [of pesticides] was FQPA, and once this interpretation is drinking water models are not associated with direct handling and corrected, it becomes clear that the conservative, the IWG points out that application of pesticides. However, for objections, for the most part, are flawed. NRDC ‘‘gives no reasons for this children and spouses not involved in Second, in the alternative, the IWG, assertion.’’ Id. at 12. The IWG takes the pesticide handling and application, assuming the EPA’s aggregate exposure contrary view arguing that the models exposures were low and did not vary interpretation is retained, explained are very health protective (conservative) appreciably by day of study.’’ Id. at 15 why the objections still are without ‘‘because their input parameters are (emphasis in original). merit. extremely conservative.’’ Id. at 11. In d. Pesticide exposure from food The IWG argues that, under the safety support, the IWG notes that EPA models purchased at farm stands. The IWG standard in section 408 of FFDCA, 21 ‘‘assume maximum [pesticide] challenges the NRDC’s assertion that U.S.C. 346a, the concept of aggregate application rates, 100% of crop area levels of pesticide residues in foods exposure to pesticide chemical residues treated with a maximum fraction of the purchased at farm stands are higher is restricted to aggregate exposure to watershed planted to the modeled crop, than residue levels in food purchased at pesticide residues in food. Id. at 5-6. To maximum number of applications per other retail outlets. The IWG notes that support this interpretation, the IWG year, minimum application intervals for ‘‘NRDC does not provide information to cites to language in the safety standard multiple applications of the pesticide, support its allegations, and we are not tying aggregate exposure to exposure to and upper-bound aerobic half-life aware of any credible data to suggest ‘‘pesticide chemical residues.’’ The term estimates in soil.’’ Id. at 12. The IWG that this is the case.’’ Id. at 16. The IWG ‘‘pesticide chemical residue,’’ the IWG also cites to data collected by EPA and cites two demonstrable reasons notes, is defined as ‘‘a residue in or on the U.S. Geological Survey showing undermining NRDC’s claim: First, label raw agricultural commodity or ‘‘concentrations of 178 pesticides and directions and restrictions on pesticide processed food of . . . a pesticide their degradation products in both raw use apply equally to food grown for sale chemical . . . .’’ 21 U.S.C. 321(q). Under surface water and finished drinking at farmstands and food grown for the IWG interpretation, EPA would not water from twelve water-supply distribution through broader channels of be permitted to consider, in making reservoirs were all substantially less trade; and second, ‘‘[t]he various safety determinations on tolerances, than those predicted by EPA’s computer circumstances (weather, pest pressure, exposures to pesticides in drinking models, FIRST and PRZM/EXAMS- etc.) that affect residue levels resulting water, exposures to pesticides resulting Index Reservoir.’’ Id. from a given treatment regimen are the from application of pesticides in b. Farm children subgroup. The IWG same for those who grow crops to residences or public spaces, or most of argues that NRDC’s farm children market through wholesale channels and the farm children exposures forming the subgroup is not an ‘‘identifiable for those who grow crops to sell at basis of NRDC’s objections. Such an subgroup’’ within the meaning of the retail.’’ Id. Finally, the IWG notes that interpretation clearly defeats most of the statute. Rather, the IWG contends the assuming residue levels are at the NRDC’s claims regarding the children’s NRDC’s subgroup is ‘‘a whole series of tolerance value would vastly overstate safety factor and estimation of aggregate different groups, including children exposure amounts given that FDA data exposure. who live on farms, children who play has shown ‘‘no pesticide residues in The IWG also offers a backup legal near agricultural land, children who 41% and 73.5% of fruit and vegetable argument which would, in execution, attend schools near agricultural land, samples and either no residues or below reach much the same result. It asserts children who work on farms, children tolerance residues in 99.5% and 98.9% that even if non-food exposure is whose family members work on farms, of fruit and vegetable samples.’’ Id. at properly considered under section 408 children whose family members handle 17. of FFDCA, any non-food exposure must pesticides as part of their jobs (whether e. Regional consumption of meet the ‘‘reliable data’’ requirement in on farms or not), and children who live blueberries. The IWG disputes NRDC’s section 408(b)(2)(ii) of FFDCA. The IWG in ‘‘agricultural communities’’ assertions regarding higher defines ‘‘reliable data’’ to mean (whatever that means).’’ Id. at 13. The consumption of blueberries in regions ‘‘information to allow OPP to make a IWG asserts that these groups ‘‘have that produce the crop. The IWG notes reasonable estimate of the actual, real- nothing in common other than that they that there is both a national and world exposure distribution to add to are all children.’’ Id. Further, the IWG international market for blueberries that information on dietary exposure so that argues that the FQPA directs EPA to makes blueberries widely available probabilistic estimates of aggregate consider ‘‘major identifiable subgroups throughout the United States for several exposure can be made.’’ Id. at 10. of consumers’’ and that NRDC has not months of the year as a fresh commodity According to the IWG, the EPA demonstrated that there is anything and available year round in the frozen generally does not have data meeting identifiable about the consumption state, the condition in which over half this standard as to ‘‘exposure from patterns of its farm children subgroup. of the U.S. blueberry crop is marketed. drinking water or from residential or Id. at 14. Id. at 18. other non-occupational exposure c. Farm children’s pesticide exposure. 2. Inter-Regional Research Project routes.’’ Id. at 9. Thus, the IWG’s legal The IWG questions whether NRDC has Number 4 (IR–4). The IR-4 is a program interpretation of the ‘‘reliable data’’ shown that children who live on farms sponsored by USDA and land grant requirement basically gets the IWG to face higher exposure to pesticides universities and directed toward the same place—EPA should not be noting that ‘‘NRDC has cited selective obtaining regulatory approval for considering non-food pesticide results from epidemiological studies pesticide uses on minor and speciality

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food crops that are not likely to be to analyze and respond to these new non-farm children, based on similar supported by private sector companies. items before issuing a response. types of measurements. In addition, In its comments, the IR–4 notes that EPA examined data NRDC submitted VII. Analysis of the Issues Raised by several of the pesticides covered in the relating to airborne levels of pesticides NRDC’s Objections objections—diflubenzuron, (stemming from spray drift or imidacloprid, halosulfuron-methyl, and EPA has considered all of the issues volatilization) in farm communities. fenhexamid—are both ‘‘critical to minor raised by NRDC in its imidacloprid Finally, EPA reviewed data it has crop growers’’ and safer, reduced risk objections in acting on the petition to re- concerning the potential for pesticides pesticides. (Ref. 27). The IR–4 asserts establish the imidacloprid tolerance on to drift offsite during application. that diflubenzuron and imidacloprid blueberries. For the reasons explained Although EPA discusses its views provide alternatives to the below, EPA concludes that the safety concerning this data in more detail organophosphate pesticides and that concerns with the imidacloprid below, those views can be summarized halosulfuron-methyl is a methyl tolerance asserted by NRDC are without as follows. First, the data concerning bromide alternative. Id. merit. levels of pesticides in homes or 3. Bayer CropScience. Bayer One consistent theme emphasized by children’s bodily fluids are limited and CropScience notes that the required NRDC in its objections is the potential inconclusive, and do not demonstrate DNT has been submitted for heightened exposure of ‘‘farm children’’ that children in agricultural areas as a imidacloprid. (Ref. 3 at 1). Bayer to pesticides. Accordingly, EPA begins group receive more pesticide exposure CropScience asserts that the 3X analysis of the issues raised by the than children in non-agricultural areas. children’s safety factor imposed by EPA objections, in Unit VII.A., with an (In fact, some data suggest that pesticide should now be removed because the ‘‘a examination of the data bearing on residues in houses in urban or non- clear NOEL was established’’ in the children’s exposure to pesticides in agricultural areas may be higher than DNT. Id. at 2. Bayer CropScience also agricultural areas. Then EPA turns to those in houses in agricultural areas.) claims NRDC errs in contending that NRDC’s more specific claims. Unit Second, even if airborne pathways such percent crop treated data was relied VII.B. addresses issues regarding the as volatilization may lead to significant upon by EPA for blueberries. Bayer children’s safety factor. Unit VII.C. exposures to some pesticides, CropScience cites 66 FR 18554, 18556 covers aggregate exposure questions. imidacloprid would not be one of those (April 10, 2001) as showing that 100% Unit VII.D. responds to claims regarding pesticides. Finally, data already crop treated was assumed for use of LOAELs and NOAELs. gathered by EPA and processed through blueberries in EPA’s risk assessment. Id. A. Children’s Exposure to Pesticides in EPA’s Spray Drift Model show that the at 10. Agricultural Areas highest off-target deposition levels from agricultural applications occur adjacent VI. Response to Objections Children can be exposed to pesticides to the treated area and that deposition NRDC objected to EPA’s extension of through multiple sources and pathways. levels decrease with increasing distance a temporary tolerance for the residues of The Agency currently considers from the treatment area; moreover, and imidacloprid on blueberries. See children’s exposure to pesticides by in any event, any spray drift from Imidacloprid et al. Objections at 1. That three broad pathways: Food, drinking agricultural applications of tolerance extension expired on water, and residential use. NRDC, imidacloprid, which has residential December 31, 2003. See 67 FR 2580 however, has asserted that children uses on turf and pets, is largely (January 18, 2002). As the objected-to residing in agricultural communities irrelevant to the pesticide’s aggregate tolerance is no longer in existence, also are significantly exposed to exposure assessment, because any NRDC objections are denied as moot. agricultural pesticides through estimated exposure from spray drift Nonetheless, NRDC’s objections remain additional exposure pathways. would be dwarfed by estimated relevant to the petition that Children in agricultural areas may be exposure from the lawn and pet use. Interregional Research Project Number 4 exposed to agricultural pesticides 1. Studies focusing on exposure to filed to establish a permanent tolerance through pathways such as contact with children in agricultural areas. In for imidacloprid on blueberries. 68 FR treated fields, roadsides and other areas; examining the first set of data, EPA 5880 (February 5, 2003) (petition for contact with moving spray drift while found it useful to concentrate first on imidacloprid tolerance on the crop near application areas; contact with what the cited studies showed regarding group bushberries which includes spray drift residues left by any spray exposure levels in the children’s blueberries). EPA has analyzed NRDC’s drift that may reach their homes, yards immediate environment. These types of objections, and considering them in or other areas they frequent, such as studies have tended to focus on light of the currently available schools and schoolyards; and contact exposure levels in the children’s homes, information on imidacloprid, has with pesticide residues that have with an emphasis on the level of decided to establish the permanent volatilized after application. In addition, pesticide residues in house dust. tolerance for imidacloprid on some of these children may also be Second, EPA examined the data bearing blueberries. EPA’s analysis of the NRDC exposed to agricultural pesticides in on the actual exposure children objections and the comments received their homes via other pathways. received in agricultural areas as on the objections is below. In analyzing the potential exposure of compared to the actual exposure levels As noted in Unit II.A., if NRDC refiles children in agricultural areas, EPA first of children in non-agricultural areas. the same objections to the re-established focused on data from studies relied a. Potential for exposure due to imidacloprid tolerance relying solely on upon by NRDC or otherwise known to heightened pesticide levels in the homes the information and arguments already EPA that attempted: To measure levels of farm children. NRDC’s argument that presented, EPA will re-issue this of pesticides in the homes of children in farm children experience higher comment response as a response to agricultural areas; to measure levels of pesticide exposures than other children NRDC’s objection forthwith. If, however, pesticide metabolites in body fluids of relies primarily on studies purporting to NRDC adds new issues, cites new children in agricultural areas; and/or to show that there are higher information, or makes new arguments in compare levels of pesticide exposure of environmental levels of pesticides in support of its objections, EPA will have farm children to those experienced by and around the homes of farm children.

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Leaving to one side, for the moment, the house dust measurements were taken lead to the potential exposure of young issue of whether such elevated from two locations in each house: children to agricultural pesticides in environmental levels of pesticides • Three feet inside the entry way. residential environments (Ref. 9 and actually increase farm children’s • In the children’s play area. Ref. 5), the challenge would remain to exposures, EPA first has focused on This study’s authors reported find an association between house dust whether such elevated levels actually significantly higher indoor dust levels of concentrations and indications of dose exist. In evaluating this question, EPA azinphos-methyl, chlorpyrifos, and based on measurements of biomarkers of has concentrated on the levels of parathion in agricultural homes as pesticides in farm worker’s children. pesticides in house dust, because nearly compared to the reference homes. The evidence likewise is fragmentary, at all the contemporary literature Analysis of the pesticide residues in the best, on this point. addressing the potential exposure of soil and house dust samples showed Fenske et al., for example, ‘‘were farmworker children to agricultural that the pesticide residues present were unable to demonstrate a strong pesticides includes a discussion or of agricultural origin, demonstrating in relationship between housedust measurements of pesticide the authors’ view that children of concentrations and biological levels,’’ concentrations in house dust. This agricultural families have a higher i.e., levels in study participants, in matrix is now widely recognized as a potential for exposure to agricultural Wenatchee area residents. (Ref. 14). potential reservoir for many pesticides than children of non-farm These researchers suggested that this environmental pollutants, including families. In addition, the authors was due to several factors, including the pesticides. In addition, EPA has concluded that proximity to agricultural tendency of the vacuum system used to reviewed not only studies submitted by spray areas appeared to be the capture ‘‘particles from deep carpet’’ NRDC, but also other studies known to predominant but not exclusive areas that ‘‘may not represent chemical EPA. (Ref. 40). explanation of the increased soil available to children during normal The house dust evidence, contrary to concentrations. residential activity.’’ The researchers NRDC’s view, is fragmentary at best as The study’s authors, however, focused also pointed to ‘‘the complexity to whether there exists a potential for on a specific and perhaps unique inherent in children’s exposures’’ higher exposure to ‘‘farm children’’ due geographic area. As other study authors through ‘‘intermittent contact with to higher environmental contamination have reported, Wenatchee, WA, can be surfaces [and] variable hand-to-mouth of the homes of such children. For characterized as being situated in an behaviors,’’ as well as the ’’relatively example, house dust samples collected area of canyons ‘‘conducive to wind high variability’’ associated with the from diverse locations such as Cape patterns responsible for spray drift’’ spot urine sampling method used to Cod, MA; Long Island, NY; Iowa City, (Ref. 11). The site-specific obtain biological values. IA; Detroit, MI; Seattle, WA; and Los characteristics of this area may not Similarly, although Simcox et al. Angeles County, CA have been necessarily apply to other agricultural demonstrated the potential migration of compared to house dust samples taken areas, such as those like Yuma County, agricultural chemicals from an from the homes of farm workers in which, as mentioned in this unit, is application site to a residence under the agriculturally intensive Yuma County, situated on a riparian flood plain, and unique circumstances of the Wenatchee AZ. Contrary to NRDC’s general is distinct from the canyons of the study, they also questioned the hypothesis, in Yuma County, the 90th Wenatchee area in terms of cropping relevance of house dust concentrations percentile dust concentrations (µg)/g) systems, application techniques and in samples collected by the vacuum for the pesticides chlorpyrifos, diazinon, topography. In fact, when University of system used in the study. Like Fenske carbaryl, propoxur, and the disinfectant Washington investigators began et al., Simcox and colleagues were not ortho phenylphenol all were lower than assessing house dust concentrations of sure if the house dust measurements those in most, if not all, of the farm worker houses in the Lower taken with the system were aforementioned urban areas.(Ref. 8). Yakima Valley of Washington, an area of representative of the house dust This may well be due to the fact that, that state that is more expansive than routinely encountered by children in addition to being agricultural the Wenatchee area, they did not living in those homes. It was suggested pesticides, all of these pesticides are observe an association between that biological monitoring of these widely used residential pesticides, proximity to fields and house dust young children ‘‘may serve as an which may be used substantially in concentrations. Rather, these appropriate and noninvasive means of urban areas as well. investigators observed a stronger sampling exposure among small Studies also have been performed in correlation between house dust children.’’ the agricultural area around Wenatchee, concentrations and dust concentrations For other reasons as well, these and WA, which is situated in the heart of the in vehicles used by farm workers to other studies have provided little data to apple growing region in that state. For commute to and from work. (Ref. 11). In support either the hypothesis that example, Simcox et al. (Ref. 63) addition, for chlorpyrifos, a pesticide pesticide levels in house dust are designed a study of housedust and soil once having both residential and correlated to exposure levels or the samples in this area in an attempt to agricultural uses, the range of house hypothesis that children in agricultural determine whether children of dust concentrations reported by Simcox areas generally receive significantly agricultural families were exposed to (Ref. 63) (<0.02–3.6 µg/g) was exceeded higher exposure to pesticide residues higher levels of pesticides than children by the median value house dust than children in the general population. whose parents were not involved in concentration from non-agricultural i. Studies allowing comparison of agriculture. Forty-eight applicator and family homes (4.7 µg/g; n=9) reported in children from agricultural and non- fourteen reference families were Jacksonville, FL. (Ref. 22). agricultural areas. In Fenske 2000a, for recruited to participate. Families living b. Whether farm children actually example, Fenske et al. compared the within 200 feet of an orchard were experience increased exposure. DMTP (dimethylthio phosphate) classified as agricultural families, while Assuming for the purposes of argument, concentrations reported in a 1995 study families living in homes more than one- moreover, that contaminated house dust of the Wenatchee population with those quarter mile from an orchard were may indicate activity patterns (in measured in Seattle children, and found classified as reference families. Pooled addition to tracked-in drift) that can that concentrations from the Seattle

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children (Ref. 32) appeared to be similar ii. Studies focusing solely on children to the farm workers themselves to those of the Wenatchee reference from agricultural areas. Other studies suggested that it was unlikely that the population—i.e., children in an have focused solely on children in exposures experienced by the applicator agricultural area. This suggested that agricultural areas, including studies children in the Loewenherz study were biological pesticide metabolite levels for performed in the Wenatchee area by sufficient to produce acute health agricultural and non-agricultural Fenske and his colleagues at the effects. (Ref. 31). Finally, a strong children were very similar. Therefore, University of Washington. Loewenherz relationship between pesticide house even if agricultural children could be et al. (1997), for example, used members dust concentrations and biological said to have the potential for more of the Wenatchee study population (48 levels in these children was not found. routes of exposure, they were not more applicator families and 14 Wenatchee- (Ref. 14). highly exposed. (Quite possibly, the area reference families) to evaluate and Using a larger cohort (109 children) metabolites found in the urine represent compare levels of OP pesticide from the same region, Lu et al. (2000) exposure to the breakdown products metabolites in urine. Their study aimed collected environmental and biological themselves rather than to the parent specifically to: samples to evaluate the total potential compounds. (Ref. 15). • Measure urinary metabolite levels exposure of agricultural and reference Work performed by Higgins et al. of OP pesticides in children living with children. The researchers took spot (2001) also allows a comparison of occupationally exposed parents. urine samples, as well as hand wipe • agricultural children to non-agricultural Compare these with a reference samples, house and vehicle dust children. This study measured population. samples, and surface wipe samples from • cholinesterase levels as a biomarker of Evaluate the relative importance of various surfaces (including steering organophosphate pesticide exposure in the para-occupational exposure wheels and work boots). Environmental a group of migrant farm workers and pathway. measurements indicated that children their children. The researchers collected One hundred sixty spot urine samples living with parents who work with blood samples from two groups of were collected from 88 children, agricultural pesticides (applicator Hispanic children (age 3—6 years) in including repeated measures 3–7 days children), or who live in close proximity the summer of 1997 to compare apart. Because the researchers detected to pesticide-treated farmland, have the DMTP with far greater frequency than cholinesterase levels in populations potential for higher exposures than do any other alkylphosphate, they chose it with varying degrees of contact with other children living in the same as this population’s most appropriate agriculture, and hypothetically varying community. (Ref. 33). However, biomarker of exposure. Over two levels of contact with organophosphate dimethyl OP pesticide metabolite levels sampling rounds, however, Loewenherz pesticides. Ninety-eight migrant in the urine of agricultural and reference and colleagues detected statistically Hispanic farm worker children (50% children showed only a marginally significant differences in the frequency male, 50% female) were recruited from significant difference. Id. The children of DMTP detectability among applicator two counties in Oregon. (Ref. 25). A of farm workers, moreover, had the and reference children in only one seasonally and age-matched comparison same range of urinary DMTP as the round, and those differences were only group of 53 Hispanic, non-agricultural reference children, and less urinary marginally statistically significant. From DMDTP (dimethyldithio phosphate) family children (64% male, 36% female) this one exposure event, there was no was also recruited in 1998 from two than applicator children. Diet is likely way to conclude what the potential for to have been an important contributor to non-agricultural areas in Oregon. exposure could be for each population Results from these two groups showed metabolite concentrations. Id. participating in this study. Moreover, Interestingly, 23 agricultural families that cholinesterase levels were not the sample sizes represented by the significantly different between the that participated in this study also populations were small, and thus participated in the study reported by agricultural and non-agricultural diminished the value of the study in children (analysis of variation Simcox et al. (Ref. 63). Of these, the four general. homes that had the highest house dust (ANOVA), p=0.69). (Ref. 25). A further The Loewenherz team, moreover, did analysis of the data using a multiple concentrations in 1992 had lower not address the potential sources of concentrations in 1995. Overall, 16 of 23 regression model to account for exposure to pesticides from gardens, households reported lower house dust potential age and gender effects also pets, lawns, and diet. Although the concentrations than in the previous supported the conclusion of no researchers recognized that this study, suggesting that changes in significant difference between the two population’s use of residential activity patterns can influence levels of groups. (Ref. 25). pesticides was less than the national Finally, in its report entitled Pesticide pesticides in house dust. average, it is still possible that In addition to the azinphos-methyl Exposure and Potential Health Effects in exposures from air, dietary intake, and and phosmet results reported in Lu et al. Young Children Along the U.S.-Mexico pesticide use in other settings where the (2000), Fenske et al. (2002) measured Border, EPA concluded that: children may have spent time (i.e., day population distributions of OP chlorpyrifos and parathion in [organophosphate] pesticide exposure in care centers, homes of others) may also environmental samples from the homes children (either living in close proximity to have contributed to observed urinary of the same 109 children and those agricultural fields, i.e., Yuma Study, or being metabolite concentrations. (Ref. 31). In chemicals’ metabolic by-products in admitted to health clinics with flu-like fact, misuse of a non-residential biological samples from the children symptoms, i.e., Symptomatic Children Study) pesticide for residential purposes was themselves. In their study, Fenske et al. as measured by alkyl phosphate metabolites reported in the study. This may have relied on more specific urinary are not significantly different than had a significant impact on the urinary metabolites of the diethyl, OP parent population distributions of OP pesticide metabolite levels reported in this paper, compounds. For chlorpyrifos, the exposure for the general population as measured by NHANES III Studies [National as two of the three highest researchers used the metabolite 3,4,6- Health and Nutrition Examination Survey measurements in the study came from trichloro-2-pyridinol (TCPy) as a conducted by the Department of Health and these households. biological measure, and for parathion Human Services]. In addition, a comparison of the they used 4-nitrophenol as the (Ref. 67) exposures of the farm worker children biological measure. Environmental

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pesticide loadings, however, could not between house dust and proximity to and DETP were higher among Fresno- explain the biological levels measured. fields and orchards. The DAP area farm workers and their children (Ref. 13). Fenske et al., stated that the metabolites measured were DMP than among the general population use of OP pesticides in gardens was (dimethyl phosphate), DMTP, DMDTP, sampled during the National Health and associated with an increase in the TCPy DEP (diethyl phosphate), and DETP Nutrition and Examination Survey concentrations in children’s urine. (diethylthio phosphate), and may (NHANES) II survey. However, However, no explanation was offered for represent exposure to numerous informational data on pesticide use this association. Unfortunately, TCPy is pesticides from several pathways practices in the U.S. general population a ubiquitous compound in the including diet and pathways associated supplied by the authors suggested that environment and exposure could still be with residential use of pesticides. The this comparison was unfair, since associated with exposure to both authors speculate that it is also possible NHANES II was survey data collected chlorpyrifos and TCPy. The authors that some workers may have taken through 1980, when the prevalence of reported that most children studied did agricultural chemicals from work for OP pesticide use was only just not have measureable urinary levels of home use. beginning to increase. In a second metabolites of either chlorpyriphos or It has been suggested that the removal comparison, Mills and Zahm showed parathion. The study concluded that of shoes prior to entering the house, or that the frequencies of detection and children living in homes including the use of entry mats, can significantly mean levels of DMTP among Fresno household members who worked with lower the amount of pesticide tracked- children were intermediate between agricultural pesticides or that were close indoors. (Ref. 38). Other investigators those found by Fenske and his co- to pesticide treated farmland did not have observed mixed or inconclusive workers among Wenatchee, Washington appear to have increased pesticide results. (Refs 33, 11 and 66). When Curl applicator and reference children. Id. exposures, even though their homes et al. (Ref. 11) compared concentrations No statistical analyses were conducted showed elevated levels of pesticide of urinary DAPs and OP concentrations on these data comparisons. Thus, it was concentrations in house dust. in house dust and vehicle dust between unclear whether the urinary metabolite Using the data gathered in their field two groups (Intervention and Control, levels seen in the Fresno children were studies, Fenske and colleagues (2000b) Lower Yakima Valley), no significant significantly different from the also compared spray season and single- differences were seen. The intervention applicator and reference children day dose estimates for agricultural and group performed activities such as studied in Washington State. reference children, but only showed a washing hands after work, removing iii. Ongoing research on farm children marginal difference between the two footwear prior to entering the house, exposures. Preliminary information cohorts. (Ref. 15). Moreover, a majority washing work clothing separately, and from the Farm Family Exposure Study of the children classified as reference removing work cloths before holding (FFES) conducted by investigators at the children had measurable children. If intervention has no impact, University of Minnesota and Emory dialkylphosphates in their urine, and a it is not clear then whether para- University bears on the question of substantial fraction had doses that occupational pathways are indeed whether farm children have higher exceeded the reference values for significant. In general, Thompson et al. levels of pesticide exposure than non- azinphos-methyl. Id. (Ref. 66) saw no differences regarding farm children, and whether farm An additional team based at the hygiene practices such as removing children should be identified as a major, University of Washington examined 571 shoes prior to entering the house identifiable subgroup of consumers. In farm workers involved in a community between households having children this study, researchers identified intervention project in the Washington and those that did not. However, the urinary pesticide concentrations for 95 State’s Lower Yakima Valley. This authors suggested the need for farm families before, during, and for 3 project is presented in Thompson et al. continuing current educational efforts. days after an application of glyphosate, (2003) and Curl et al. (2002) (Refs. 66 As compared to field workers, pesticide 2,4-D or chlorpyrifos. In their and 11). The cohort consisted of field handlers were more likely to perform preliminary reporting of results, the workers and pesticide handlers (e.g., protective practices such as washing researchers stated that they found ‘‘ applicators). Questionnaires regarding hands immediately after work and appreciable variation by chemical in the self reported pesticide exposure and removing work clothing before holding proportion of farm family members with common sense methods to reduce para- children. Yet, in other studies, detectable urinary concentrations.’’ See occupational exposure were evaluated. concentrations in urine were higher http://www.farmfamilyexposure.org/ Sub-samples of urine and other among children of applicators than html/abstracts.html#ser/. However, it environmental media (house and among children of field workers. (Ref. was only in the case of farmers—not vehicle dust) were taken to establish 33). spouses and children—that the baseline exposure levels of the Finally, Mills and Zahm (Ref. 34) researchers claimed to have detected intervention and control groups. conducted a feasibility study to obtain significant differences in urinary Intervention was described as urine samples from farm workers and pesticide concentrations and patterns of individuals performing common sense their children in an area of extensive OP uptake and elimination. Id. ‘‘For the hygiene practices such as removing use. They tested for six urinary vast majority of spouses and children, footwear prior to entering the house. metabolites of OPs, including DMP, urinary concentrations did not change Based on this research, both DEP, DMTP, DMDTP, DETP, and appreciably after pesticide application.’’ Thompson et al and Curl et al. reported DEDTP. They also compared the levels Id. Moreover, the researchers asserted, a significant association between levels between adults and children living in based on their findings, that ‘‘little of dialkyl phosphates (DAP, a class of the same households. A total of 27 pesticide exposure is received through . breakdown products of individuals from 9 families (18 adults . . living on a farm, per se,’’ and that it organophosphate pesticides) in urine of and 9 children) were selected to is the following, specific behaviors adults and their children. There was participate. Levels of OP metabolites instead that are associated with elevated also a significant association between were generally very low in both adults pesticide exposure for farm children: house dust and vehicle dust. However, and children in this survey. The • ‘‘[d]irect contact with chemicals in Curl et al did not report an association frequencies of detection of DMP, DMTP, the mixing or application area.’’

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• ‘‘[w]orking as a co-applicator.’’ • A similar study which the federal highest potential as toxic air • ‘‘[t]ouching containers without government itself is conducting with contaminants as well as several gloves.’’ children in North Carolina and Iowa. pesticides categorized as hazardous air • ‘‘[p]laying barefoot in the area • A systematic analysis which EPA pollutants. The screening level where pesticides are being mixed and is undertaking to review the raw data assessment only identified four soil loaded[.]’’ underlying the Wenatchee, WA area and fumigants as potentially presenting non- See http://www.farmfamilyexposure.org Yuma County, AZ studies discussed in cancer acute or chronic risks of concern. /html/the_study.html. this unit. Id. at 1179. The study concluded that • EPA recognizes that these A study of pesticide exposure ‘‘vapor pressure is a significant representations of the researchers are pathways for farm workers’ children in predictor of [] ranking of inhalation the Yakima Valley. risks.’’ Id. at 1182. The CFPR Report only preliminary. Nevertheless, the fact • that the FFES researchers’ preliminary An assessment of sources of examined the potential health risks from pesticide contamination, concentrations views point in the same direction as the air levels of three pesticides in pathways, and exposure-prone analysis above should not escape note. characterized as moderate to highly behavior in Salinas, CA. volatile (chlorpyrifos, diazinon, and In sum, as discussed in this unit the • A study of ingestion of pesticides studies and information, whether molinate) measured at the field by children in an agricultural boundary and at more distant locations. concerning children in agricultural community on the U.S./Mexico border. areas and non-agricultural areas or • The Report concluded that in many An assessment of exposure of instances the measured air levels of children in agricultural areas alone, and children to pesticides in Yuma County, whether concerning environmental these pesticides posed risks of concern. AZ. The Report also concluded that drift due levels, biological levels, or both, shows EPA will review the results of this that there is little or no evidence to to volatilization was not a concern for ongoing research and take appropriate pesticides that are not highly volatile. indicate that EPA has ignored a steps to address any exposure concerns significant source of exposure in CFPR Report at 40. regarding children that are documented. Even assuming that volatilization may calculating the potential aggregate 2. Supplemental information lead to significant exposures to some exposure from pesticides. regarding spray drift and drift of pesticides, imidacloprid would not be c. Conclusion. In conclusion, the volatilized residues. On June 19, 2003, one of those pesticides. EPA is in limited number of studies containing NRDC supplemented its submission to general agreement that vapor pressure is data relevant to NRDC’s arguments, the Agency with several pieces of the key factor in predicting whether a taken together, fail to demonstrate that additional information. Included was a pesticide has the potential to volatilize children in agricultural areas experience report generally addressing the issue of and drift offsite in significant amounts. significantly higher levels of exposure spray drift from pesticide applications Because soil fumigants traditionally than children in non- agricultural areas. in California (Ref. 7) (hereinafter cited have very high vapor pressures, and In EPA’s judgment, the weight of as the CFPR Report). Although EPA thus are highly volatile, EPA is now currently available evidence relating to defines spray drift as the movement of accounting for potential exposure due to pesticide residues in house dust or on droplets off-target during or shortly after volatilization of these pesticides in other surfaces fails to establish that application, which is independent of calculating their aggregate exposure. children living in agricultural areas or the chemical properties of the pesticide Imidacloprid is a solid at room children living nearer to agricultural being sprayed, the CFPR Report looked temperature with a low vapor pressure pesticide use areas experience higher more broadly at atmospheric pesticide (1.5 x 10-9 mmHg). In fact, exposures to pesticides than children in transport including pesticide imidacloprid’s vapor pressure is not the general population. Similarly, volatilization as a potential mechanism only much lower than pesticides used biomonitoring data available for by which pesticides travel beyond as soil fumigants, it is also substantially comparing the levels of pesticide treated fields.This section of the lower than the pesticides presented in exposure experienced by agricultural document discusses drift as a result of NRDC’s supplementary submission: children with other children is volatilization. Drift of the pesticide chlorpyrifos (1.87 x 10-5 mmHg); fragmentary and does not show that spray is addressed in the following diazinon (1.4 x 10-4 mmHg); molinate there are significant differences between section of the document. Also included (5.3 X 10-3 mmHg). Thus, any losses due these groups of children. Thus, in NRDC’s supplemental information to volatilization for imidacloprid are regardless of whether such children was a research article entitled expected to be minimal at most. constitute a ‘‘major identifiable ‘‘Community Exposures to Airborne 3. EPA Data on Spray Drift and the subgroup of consumers,’’ it does not Agricultural Pesticides in California: Spray Drift Model. EPA has gathered appear that such children consistently Ranking of Inhalation Risks,’’ containing substantial data on the potential of receive more pesticide exposure than an analysis of the degree of inhalation pesticides, as applied, to drift offsite the groups of children (those at the risk posed by certain migrating through the work of the Spray Drift Task upper percentile of estimated exposure) pesticides in California, based on Force (SDTF). The SDTF is a group of used by EPA in its current approach to ambient air monitoring data gathered, in pesticide registrants who have worked assessing aggregate risk. part, by the California Air Resources collaboratively to develop a database to This is not to say, however, that Board and the California Department of meet the majority of their collective issues addressed in these materials do Pesticide Regulation. (see Ref. 29, spray drift data requirements under 40 not bear further research. On the hereinafter referred to as the Ranking CFR 158.440. The group was chartered contrary, the government is engaged in Study). EPA is still examining the on April 17, 1990, and its formation was or supporting, or has recently engaged information in these studies but announced in PR Notice 90–3. Since its in or supported, relevant research in a presents its preliminary views on these formation, the SDTF has generated number of ways. These efforts include, studies in this unit. standardized data on spray drift levels for example, the Minnesota and South The Ranking Study conducted resulting from different application Carolina study discussed in this unit. screening level assessments for many of methods under varying meteorological These efforts also include: the pesticides ranked as having the conditions. The data developed by the

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SDTF was reviewed by EPA internally, chemigation, respectively. After the The AgDRIFT model and the SDTF through external peer review spray drift data were available, the data show that the highest off-target workshops, and through FIFRA SDTF worked with EPA’s Office of deposition levels from agricultural Scientific Advisory Panel meetings. The Research and Development, as well as applications occur adjacent to the reviews generally identified the data set the USDA’s Agricultural Research treated area and that deposition levels associated with aerial applications to be Service and Forest Service to use the decrease with increasing distance from the most robust, followed by the data data in the development/evaluation of the treatment area. See Table 2 of this sets from ground boom applications, the AgDRIFT model. (See generally Refs. unit. orchard/vineyard airblasting, and 4, 24, and 65).

TABLE 2.—HIGH-END DOWNWIND SPRAY DRIFT DEPOSITION LEVELS BY APPLICATION METHOD

Spray drift deposition (percent of application rate)

Lawn placement relative 3 to application area airblast aerial1 ground boom2 granular4 dormant orchards dense or tall canopies

10 to 60 ft downwind 34.1 9.3 25.0 8.4 0

20 to 80 ft downwind 31.6 6.4 16.1 6.0 0

40 to 90 ft downwind 27.9 4.1 8.0 3.7 0

80 to 130 ft downwind 22.0 2.4 3.0 1.9 0

160 to 210 ft downwind 14.9 1.3 0.8 0.9 0 1 ASAE very fine to fine spray, 10 mph wind, 10 ft release height and other standard AgDRIFT 2.01 default inputs. 2 Tier 1 AgDRIFT 2.01 ground boom inputs: 90th percentile, high boom, fine spray. 3 Tier 1 AgDRIFT 2.01 airblast inputs: model outputs multiplied by 3 to approximate an upper 90th percentile value. 4 Particle drift from granular applications is generally considered to be insignificant in EFED assessments.

The AgDRIFT model helps EPA assess model for imidacloprid will clarify this essentially wraps its full body around the relative [upper bound] magnitude of point. the pet such that one-half of the child residues from direct residential use of a EPA estimates residential exposure by comes in contact with the pet. The child pesticide versus residues that might incorporating pesticide-specific is assumed to be wearing a short-sleeved occur as a consequence of spray drift. information in exposure scenarios that shirt and short pants. EPA assumes As of yet, EPA has not included data are built based on data on human 100% transfer where the child’s skin from the AgDRIFT model as a standard behavior and human physical statistics touches the pet and 50% transfer to the component of its residential exposure (e.g., body surface area). (See Refs. 35, child’s skin where the child’s clothing assessments. In responding to NRDC’s 55, and 61) EPA’s scenario for touches the pet (Refs. 35, 55 and 61). objections other than as to imidacloprid, estimating exposure due to turf uses For oral exposure, EPA used a EPA is still examining how this data assumes that children play for a combination of imidacloprid specific informs the understanding of aggregate substantial period (2 hours) on lawns data and its standard exposure scenario. exposure generally and how this data immediately after treatment with the EPA had imidacloprid data on the can be considered in a meaningful way pesticide. The scenario models both transfer of imidacloprid to hands from in assessing aggregate exposure. dermal exposure from contact between Nonetheless, even prior to completing skin (arms and legs) and the lawn and petting dogs that was gathered by this analysis, some conclusions can be oral exposure resulting from soil petting a treated dog 10 minutes after made concerning pesticides such as ingestion, mouthing grass, and hand-to- imidacloprid application wearing cotton imidacloprid which have broad mouth behavior (placing hands gloves. EPA assumed that a child put its residential uses. What the data for repeatedly in mouth after being in hand in its mouth 20 times/hour for 2 imidacloprid show is that predictions of contact with treated lawn) (Refs. 35, 55 hours and each time the hand contained exposure based on the spray drift model and 61). With the pet treatment, EPA the exposure level measured on the are largely irrelevant to the pesticide’s also uses scenarios for both dermal and glove. (See Ref. 44 at 51-57 and Refs. 35, aggregate exposure assessment because oral exposure. For dermal exposure, 55 and 61) any estimated exposure from spray drift EPA uses a pet hug scenario which Using these scenarios, EPA estimated would be dwarfed by estimated assumes a child hugs the pet the exposures and MOE’s for exposure from the lawn and pet use. An immediately after treatment. EPA imidacloprid residential exposures explanation of EPA’s residential assumes that 20% of the applied dose is presented in Table 3 of this unit. exposure assessment for imidacloprid available on the surface of the pet for and the operation of the AgDRIFT transfer to the child and that the child

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TABLE 3.— RESIDENTIAL EXPOSURES FOR IMIDACLOPRID

Exposure in milligram/ Use Route of exposure kilogram/day (mg/kg/ MOE day)

Lawn oral 0.0059 1,700

dermal 0.001 10,000

Pet oral 0.0027 3,600

dermal 0.036 280

(Ref. 44 at 51-52). granules and others permitting aerial highest potential for drift is on In calculating potential drift, it is spraying. The agricultural use that has artichokes where 0.25 lb/acre may be important to consider the maximum the potential for the greatest spray drift applied aerially in a single application. amount that may be applied and the is on cranberries. The label permits To calculate exposure and risk (in manner of application. Imidacloprid is imidacloprid to be applied at 0.5 lb/ terms of MOEs) from imidacloprid spray approved for use on residential turf at acre/year for cranberries and that 0.4 lb/acre/year. This amount may be drift, EPA multiplied the agricultural amount of pesticide may be applied in application rates by the high-end applied in a single application. This a single application. Further, the label application rate is comparable to the prediction of spray drift deposition does not prohibit, and therefore permits maximum agricultural yearly rate (0.5 (shown in Table 2 of this unit) and then aerial application. For cranberries this lb/acre/year) and exceeds most single applied the standard residential agricultural application rates. would generally mean application from exposure estimation methods. The Imidacloprid application methods differ a helicopter. In EPA’s experience aerial estimated exposure and MOE’s from for various crops with some uses being application to cranberries is relatively spray drift from these uses are presented restricted to soil incorporation of uncommon. The use having the second in Table 4 of this unit.

TABLE 4.—SPRAY DRIFT EXPOSURES FOR IMIDACLOPRID ON LAWNS

Exposure in mg/kg/day on lawns 10– Use Route of exposure 60 feet from edge of field MOE

Cranberries oral 0.0025 4,000

dermal 0.00035 29,000

Artichokes oral 0.00127 7,900

dermal 0.000175 57,000

(Ref. 39). by NRDC on the fact that a DNT has This committee, the FQPA Safety Factor Comparing the potential exposure from been required for imidacloprid but not Committee, was constituted solely for spray drift onto lawns from cranberries yet submitted. In addressing the issues this purpose. To a lesser extent, during with the highest residential exposure raised by these objections, EPA first has this period, OPP relied upon the another already incorporated into EPA’s summarized its children’s safety factor internal committee, the Hazard aggregate assessment, the pet hug decision that was relied upon in Identification and Assessment Review scenario, shows that worst case approving the imidacloprid tolerance Committee (HIARC) to explain EPA’s exposure at the edge of the field from and a re-analysis of that decision that rationale. Within the last year or so, drift is an order of magnitude lower. has been performed in light of the OPP has administratively restructured objections and the revision to EPA’s Thus even assuming that a child who such that most of the work regarding children’s safety policy released in mid- received maximum exposure from toxicity issues and the children’s safety hugging a treated dog was exposed to 2002. Second, EPA addresses NRDC’s factor falls within the jurisdiction of the imidacloprid at the edge of a treated contentions regarding the lack of a DNT HIARC. Consideration of exposure cranberry bog, the exposure and risk study. Third, EPA explains its response issues falls in the first instance to the assessment for that child would not be to each allegation NRDC makes meaningfully different. regarding general and pesticide-specific team of scientists of OPPs’ HED data that NRDC asserts is missing and assigned to the specific pesticide. That B. Failed to Retain Children’s 10X necessitates retention of the 10X factor. judgement is then reviewed by the Risk Safety Factor 2. EPA’s children safety factor Assessment Review Committee (RARC). 1. Introduction. NRDC’s objections decision—a. In general. In making It is the RARC’s responsibility to ensure concerning the children’s safety factor decisions regarding the children’s safety adequate rationale is provided for the focus on the question of whether EPA factor, EPA’s OPP, from 1999 until early decision on the children’s safety factor properly applied a children’s safety 2002, looked primarily to an internal and to ensure consistency with current factor of other than 10X given that EPA committee to make recommendations on policy and similar pesticides/ is allegedly missing data on each of the the children’s safety factor decision and circumstances. The RARC’s pesticides. Particular emphasis is placed to articulate a rationale for that decision. recommendation and complete rationale

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is included in the risk assessment children given the pet and outdoor same NOAEL for effects in pups and document for the pesticide. residential uses of imidacloprid. The dams. Two particular aspects of that new data indicating a potential for 3. The doses and endpoints selected policy are worthy of mention. First, the developmental neurotoxicity included for regulatory purposes are protective of policy emphasizes that in applying the structure activity relationship the pup effects noted at higher doses in provision the focus should not be information and data from a 2-year the developmental neurotoxicity study. simply on whether the young have a study in rats showing neurotoxic effects Therefore, there are no residual greater sensitivity to a pesticide but following a single oral dose. (Ref. 56 at uncertainties for pre-/post-natal toxicity rather on what reliable data show with 6). in this study. • regard to the safety of infants and The DNT has now been submitted and The toxicological database is children in situations where studies complete for FQPA assessment. reviewed. It showed evidence of an • have shown that the young are more increased qualitative susceptibility in The acute dietary food exposure sensitive to a pesticide. Thus, where the rat. At the highest dose tested (750 assessment utilizes existing and increased sensitivity is demonstrated, parts per million (ppm)), maternal proposed tolerance level residues and EPA examines how well-defined that effects consisted largely of slight 100% [crop-treated] CT information for all commodities. By using these sensitivity is by the existing toxicity decreases in food consumption and screening-level assessments, actual data and whether that sensitivity has body weight gain during early lactation, exposures/risks will not be been adequately taken into account in while pup effects included decreased calculating a safe MOE. underestimated. body weight, decreased motor activity, • The chronic dietary food exposure Second, the policy stresses that when decreased caudate/putamen width, data are missing or inadequate the focus assessment utilizes existing and females only (post-natal days 11 and proposed tolerance level residues and % should be on whether there are reliable adult), and slight changes in data to show that any additional safety CT data verified by [OPP’s Biological performance in the water maze, males and Economic Analysis Division] BEAD factor different than the 10X default only, at the same dose. The NOAEL value is protective of the safety of for several existing uses. For all identified in the DNT (20 mg/kg/day) proposed uses, 100% CT is assumed. infants and children. This issue has was higher than the NOAELs previously arisen frequently with regard to the The chronic assessment is somewhat identified (ranging from 5.7 to 10 mg/ refined and based on reliable data and developmental neurotoxicity study kg/day) and thus the DNT results had no (DNT), a study that EPA is now will not underestimate exposure/risk. impact on regulatory endpoint selection • The dietary drinking water requiring to be submitted for more and the risk assessment. The HIARC pesticides. In evaluating whether a assessment utilizes water concentration concluded the DNT indicated no different factor than 10X would be values generated by model and residual concerns regarding post-natal protective of infants and children where associated modeling parameters which toxicity based on: a required DNT is absent, EPA examines are designed to provide conservative, • The effects in pups are well- related studies in the database to health protective, high-end estimates of characterized with a clear NOAEL. water concentrations which will not develop a sense for the likely range in • which effects may be seen in the DNT The pup effects occur in the likely be exceeded. (and therefore, the range of doses which presence of maternal toxicity with the • The residential handler assessment will be used in the DNT). When the same NOAEL for effects in pups and is based upon the residential [Standard dams. Operating Procedures] SOPs in expected doses in the DNT are • substantially higher than the doses that The doses and endpoints selected conjunction with chemical-specific are presently providing the regulatory for regulatory purposes are protective of study data in some cases and [Pesticide endpoint, a different and lower the pup effects noted at higher doses in Handlers Exposure Database] PHED unit additional safety factor may be the developmental neurotoxicity study. exposures in other cases. The majority appropriate depending on the degree of (Ref. 46 at 9). of the residential post-application difference between the doses for the EPA ultimately determined that, other assessment is based upon chemical- DNT study and the current regulatory than a 3X factor for acute risk specific [Turf Transferable Residue] endpoint. On the other hand, where the assessments to address the lack of a TTR data or other chemical-specific range of expected doses in the DNT NOAEL in an acute study, no other post-application exposure study data. parallels the levels at which effects have additional safety factors were needed to The chemical-specific study data as well already been identified in the database, protect the safety of infants and as the surrogate study data used are it is less likely that there will be a children. This conclusion was based reliable and also are not expected to reliable basis for assigning an additional upon: underestimate risk to adults as well as factor lower than 10X. • There is no quantitative or to children. In a few cases where b. Imidacloprid. The FQPA Safety qualitative evidence of increased chemical-specific data were not Factor Committee recommended an susceptibility of rat and rabbit fetuses to available, the SOPs were used alone. additional safety factor of 3X for in utero exposure in developmental The residential SOPs are based upon imidacloprid for the protection of studies. There is no quantitative or reasonable ‘‘worst-case’’ assumptions infants and children. Although available qualitative evidence of increased and are not expected to underestimate studies demonstrated no indication of susceptibility of rat offspring in the risk. These assessments of exposure are increased sensitivity of rats or rabbits to multi-generation reproduction study. not likely to underestimate the resulting in utero and/or postnatal exposure to • There is evidence of increased estimates of risk from exposure to imidacloprid, the Committee concluded qualitative susceptibility in the rat imidacloprid. (Ref. 44 at 22). that an additional factor of 3X was developmental neurotoxicity study, but Although the HIARC’s conclusions needed due to the fact that there was the concern is low since: regarding exposure are stated in terms of data indicating a potential for 1. The effects in pups are well- the imidacloprid exposure estimates not developmental neurotoxicity (and, characterized with a clear NOAEL. being expected to ‘‘underestimate risk,’’ therefore, a need for a DNT study) and 2. The pup effects occur in the in all likelihood, the imidacloprid the potential for exposure to young presence of maternal toxicity with the exposure assessments substantially

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overstate exposure. This overestimate of 4. Missing exposure data - general— pesticide residues in every sip of water exposure is a result of the aggregation of a. Farm children exposure. NRDC argues and every bite of food as it is being worst case or, at the least, very that EPA is lacking data on exposure to consumed, OPP must model or estimate conservative (health protective) farm children and thus may not remove exposure values for residues in drinking estimates of, exposure through each the additional 10X safety factor. EPA water and food. The need for models pathway of exposure - food, water, and disagrees. As discussed above, the data exists whether the exposure estimate is residential. For food, EPA used a worst submitted by NRDC have not shown based on monitoring values in drinking case approach of assuming all food that there are significant exposures to water and food, residue values from which can be legally treated with farm children that occur as a result of field studies, or data on a pesticide’s imidacloprid bears imidacloprid living in close proximity to agricultural properties and characteristics which are residues at the tolerance level for operations. EPA concluded that the used to predict anticipated residue assessing acute risk. Tolerance values evidence presented by NRDC is levels in water and food.’’ (See Ref. 47 are chosen to be slightly higher than any fragmentary, at best, as to whether at 149) Accordingly, NRDC errs to the expected residue values at the time of pesticide exposure levels in homes of extent it attempts to cast models as the harvest assuming maximum application children living in agricultural areas are antithesis of data. The question is not practices are followed (See Ref. 51 at significantly different than levels in whether EPA is relying on reliable data 11). Assuming tolerance values in food other homes and whether children or a model but whether the model EPA fails to take into account that pesticides living in agricultural areas have is using is based on reliable data. Id. are infrequently used on more than a significantly different exposures than (‘‘[T]he reliability of any method of relatively small fraction of a crop, that non-agricultural children. estimating exposure will have to be pesticides are not uniformly applied at After reviewing all of this data, EPA evaluated based on what data the the maximum application rate, that even concludes it has sufficient reliable data method relies upon’’). when pesticides are applied at the to find that an additional 10X factor is For imidacloprid, EPA relied on a maximum application rate much of the not needed to protect the safety of combination of modeling information treated crop will have residues well infants and children with regard to any and pesticide-specific data. EPA below the tolerance level, and that uncertainties due to lack of data on concluded that use of this information pesticides often degrade substantially exposure of farm children to pesticides. was unlikely to underestimate exposure between the time of harvest and Specifically with regard to to the imidacloprid in drinking water. consumption naturally or as the result imidacloprid, EPA is confident that its EPA believes that a description of its of food processing or cooking. Id. at 10- exposure assessment is protective of all drinking water models and their 12, 17-30. For assessing chronic risk, children given that it has taken into underpinnings, an evaluation of how EPA took only a slightly less account, in its aggregate exposure these models have performed generally, conservative approach by incorporating assessment, that imidacloprid is and a review of the data pertaining to percent crop treated data for registered for use on pets and turf. imidacloprid demonstrates that this approximately B of the commodities EPA’s aggregate assessment has conclusion was reasonable. Hence, EPA having tolerances. All treated assumed that children will come in finds that in using these models and the commodities were still assumed to bear direct contact with treated pets and turf. pesticide-specific imidacloprid data it tolerance level residues. Indirect exposure from agricultural uses was acting on the basis of reliable data. For water, EPA estimated possible is unlikely to be significant compared to (See Ref. 48 at A-7) (‘‘OPP does not exposure with a surface water exposure direct exposure to treated pets and turf. interpret the reliable data requirement model (Pesticide Root Zone Model and Additionally, EPA has found the chance in the infants and children’s provision the Exposure Analysis Model System) of pesticide exposure as a result of the as mandating that any specific kind of that generally produces very volatilization of pesticide residues in data be available, just that the data and conservative (health protective) the field to be extremely slight given the information that form the basis for the estimates of exposure. As the analysis in vapor pressure of imidacloprid. selection of a different safety factor must Unit VII.B.4.b.ii. shows, this model b. Lack of comprehensive DW be sufficiently sound such that OPP generally substantially over predicts monitoring data. NRDC contends that could routinely rely on such residue levels in water, frequently by because EPA used a model for information in taking regulatory orders of magnitude. Finally, for calculating drinking water exposure to action.’’) residential exposure, EPA relied on imidacloprid that, as a definitional ii. EPA’s drinking water models. models using conservative (health matter, EPA does not have ‘‘reliable Although the availability of drinking protective) assumptions that are also data’’ for choosing a factor different than water monitoring data has increased likely to overstate actual exposure. the 10X default value. Similar dramatically in the last several years, These assumptions are described in comments were made during the EPA still finds it necessary to rely for detail in Unit VII.A.3. development of EPA’s Children’s Safety most pesticides upon various exposure 3. Missing toxicity data - lack of DNT. Policy. For the reasons below, EPA models to estimate exposure levels in NRDC contends that ‘‘the absence of rejects NRDC’s claims. drinking water. As explained below required developmental (DNT) tests for i. Models and data. Modeling is a these models are based on generic data imidacloprid, mepiquat, and zeta- necessary part of both the hazard and regarding fate and transport of cypermethrin is a crucial data gap that exposure components of risk pesticides in the environment, and they by itself should prohibit EPA from assessment. In the absence of perfect operate by combining this generic data overturning the default 10X safety data, EPA must extrapolate through the with pesticide-specific data on chemical factor.’’ See, e.g., Imidacloprid use of modeling from the individual properties to estimate exposure. Objections at 6. Given, however, that the data available to more general EPA has primarily used its drinking DNT has now been submitted and conclusions concerning hazard, water models to ‘‘screen’’ those incorporated into the imidacloprid risk exposure, and risk. (See Ref. 48 at A-7). pesticides that may pose unacceptable assessment, this objection is no longer As EPA noted in responding to NRDC’s risks due to exposures in drinking water relevant to the imidacloprid tolerance comments on its Children’s Safety from pesticides not likely to result in on blueberries. Factor Policy, ’’short of measuring the such exposures. To accomplish this

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goal, the models are based on data from Estimated Environmental Whether EPA assesses pesticide studies at sites that are highly Concentrations (GENEEC) model that exposure in drinking water through vulnerable to runoff of pesticides to was used as the first tier screen by EPA monitoring data or modeling, EPA uses surface water or leaching of pesticides from 1995-1999. If the first tier model the higher of the two values from to ground water. If a pesticide fails this suggests that pesticide levels in water surface and ground water in assessing conservative (health-protective) screen, may be unacceptably high, a more overall exposure to the pesticide. In EPA would investigate whether the refined model is used as a second tier most cases, pesticide residues in surface model is significantly overstating the assessment. The second tier model is water are significantly higher than in residue levels that actually occur. actually a combination of the models, ground water. EPA has developed models for Pesticide Root Zone Model (PRZM) and Table 5 describes what models were estimating exposure in both surface the Exposure Analysis Model System used to estimate drinking water residue water and ground water. EPA uses a (EXAMS). For estimating pesticide levels with regard to imidacloprid both two-tiered approach to modeling residues in ground water, EPA uses the for the 2002 tolerance and the 2004 pesticide exposure in surface water. In Screening Concentration In Ground tolerance. The table also indicates the initial tier, EPA uses the FQPA Water (SCI-GROW) model. Currently, which model estimates were used in Index Reservoir Screening Tool (FIRST) EPA has no second tier ground water assessing overall exposure to the model. FIRST replaces the GENeric model. pesticide.

TABLE 5.—DRINKING WATER MODEL PROJECTIONS FOR IMIDICLOPRID

Model Used for Year Residue Surface Ground Water Surface Water Surface Water Ground Water Exposure As- Water Model Model acute chronic acute and chronic sessment

1998 Imidacloprid PRZM/ SCI-GROW 4.1 ppb 0.1 ppb 1.1 ppb PRZM/EXAMS parent EXAMS (acute); SCI- GROW (chron- ic)

2003 Parent and FIRST SCI-GROW 36.04 ppb 17.24 ppb 2.09 ppb FIRST (acute degradates and chronic)

2003 Parent FIRST SCI-GROW 35.89 16.52 1.43 N/A

The increase in estimated levels in revealed that the amount of pesticide percentage of pesticide applied that is surface and ground water in the 2003 transport off of the treated field by likely to enter the farm pond. In assessment is due to the use of different rainfall ranged from a low of 0.00% to estimating the amount of pesticide models (for surface water), the addition a high of 22% of the applied pesticide, entering the pond and hence the of new uses, and more updated with most of the values clustered concentration of the pesticide in the information on aerobic soil and water toward the lower end. Only 4 of the 122 pond, the instructions for the model half-lives and use of the organic carbon study values were above 10%. The recommend use of the assumption that normalized soil/water equilibrium study author recommended that the pesticide was applied at the partition coefficient (KOC) instead of the percentage loss estimates for the maximum rate permitted on the soil/water equilibrium partition pesticides most likely to be carried away pesticide label. The concentration of the coefficient (KD) (Refs. 45 and 59) For the by runoff should be from 2 to 5% based pesticide in the pond over time is recent tolerance action, EPA used the on slope of the field. (Id.; see Ref. 30) calculated taking into account the surface water estimates for calculating (‘‘Under natural conditions, pesticide aerobic aquatic metabolic half-life, the aggregate exposure because they are runoff losses in the 10% range would be hydrolysis half-life, and the photolysis higher than the levels projected for rare.’’). GENEEC assumes that the 10% half-life, of the pesticide in question. ground water. figure corresponds to pesticides with GENEEC produces a conservative a. Surface water—i. GENEEC. the greatest solubility and that estimate of levels in surface water due GENEEC uses readily-available pesticide pesticides which have a greater to the fact that the model is constructed properties to estimate peak and time- tendency to bind to soils are transported based on the highest values of pesticide averaged pesticide concentrations in a to the farm pond in lower amounts on residues found in farm ponds and that ‘‘farm pond,’’ 20 million liters (5.3 a percentage basis. The capacity of a it assumes pesticides are applied at million gallons) in capacity, located at chemical to dissolve in water or, maximum application rates. Further the edge of a 10-hectare (approximately conversely, to bind to soil is generally conservatism is added by, among other 25 acres) treated field. GENEEC is expressed as the soil/water equilibrium things, the assumption that the entire designed to simulate reasonable worst partition coefficient (KD) or the organic drainage area surrounding the farm case pesticide levels in this farm pond carbon normalized soil/water pond is planted to crops for which the following a major rainfall event. It equilibrium partition coefficient (KOC). pesticide is registered and 100% of assumes that a maximum of 10% of the The higher the KD or KOC value for a those crops are treated. Additionally, applied pesticide is removed by rainfall pesticide, the greater tendency it has to GENEEC tends to overstate residue and washed into the adjacent waterbed. adsorb or bind to soil; there is a partial values in a drinking water location The underlying data supporting correlation with the solubility of the because it is designed to represent a GENEEC is an extensive study of the pesticide with strong adsorption water body in the upper reaches of the level of pesticide residues in runoff generally associated with lower agricultural watershed. Drinking water studies. (Ref. 69). That paper provided solubility. An individual pesticide’s KD reservoirs typically have contributions a summary of 122 study values and or Koc value is used to estimate the from multiple sources. (Ref. 54 at 6)

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In the SAP’s review of GENEEC in FIRST attempts to be slightly more roughness, field geometry), pesticide 1997, ‘‘nearly all the Panel members realistic and does not assume that 100% application parameters (application rate, agreed that the pesticide concentration of the drainage area for the reservoir is application frequency, spray drift, estimates provided by GENEEC are most planted to the treated crop. As to four incorporation depth, application likely overly conservative.’’ (Ref. 18 at major crops (corn, soybeans, wheat, efficiency, application methods), 18). In late 1999, EPA revised GENEEC cotton), FIRST uses a value representing agricultural management practices by substituting a reservoir for the farm the maximum drainage area for a (tillage practices, irrigation, crop pond in the model. As indicated above, reservoir that could be expected to be rotation sequences), and pesticide this model is designated the FQPA planted to the crop in question. These environmental fate and transport Index Reservoir Screening Tool (FIRST). values are derived from geoprocessing properties (aerobic soil metabolism half- ii. FIRST. FIRST provides a slightly analysis that combines U.S. Department life, soil:water partitioning coefficients, more realistic model for estimating of Agriculture data on crop coverage foliar degradation and dissipation, and pesticide residues in drinking water with U.S. Geological Service data on volatilization). EPA selects a than GENEEC because it models a small watershed boundaries. (Ref. 57 at 8). For combination of these different drinking water reservoir instead of a all other crops, EPA assumes that 87% properties to represent a site-specific static farm pond. It maintains, however, of the pond’s drainage area is cropped scenario for a particular pesticide-crop many of the conservative features of and 100% of that cropped area is regime. GENEEC. Like GENEEC, FIRST is based treated. (See Ref. 53 at 24) (explaining The EXAMS component of the model on data concerning residue in actual choice of 87% is based on fact that 87% is used to simulate environmental fate water bodies and the data chosen to cropped was the largest cropped area in and transport processes of pesticides in construct the model represent a any 8-digit hydrologic unit in the surface water, including: abiotic and reasonable worst case scenario. continental United States). biotic degradation, sediment:water The drinking water reservoir that EPA The SAP has endorsed the concept of partitioning, and volatilization. chose to use as the Index Reservoir for using a reservoir as reasonable, but Currently, OPP is using an index modeling pesticide levels is Shipman questioned the representativeness of the reservoir and a farm pond as benchmark City Lake in Shipman, Illinois (Ref. 60 reservoir EPA chose to model. (See Ref. surface water bodies for human health at 17). Shipman City Lake is 17 at 3). Based on SAP comments, EPA and aquatic exposure assessments, representative of a number of reservoirs undertook a comprehensive review of respectively. in the central midwestern United States its Index Reservoir model. EPA For each component of PRZM/ that are known to be vulnerable to considered 82 reservoirs as candidates EXAMS, the values used are derived pesticide contamination. Id. at 18. The for modeling (Ref. 54 at 15) and selected from real world data. For example, the site at Shipman, Illinois was chosen for 20 for further investigation. Factors EPA-approved product label is the the IR because of extremely high evaluated included depth and volume of source of the application rate, pesticide concentrations found there by the reservoirs, percentage of the frequency, and method of pesticide the Acetochlor Registration Partnership reservoir that is cropped, the ratio of application. Pesticide environmental (ARP) monitoring program and because drainage area to normal reservoir fate properties used in PRZM and of its hydrologic simplicity for modeling capacity, and the availability of EXAMS modeling come from registrant- purposes (Refs. 1 and 2). In 1996, sufficient years of monitoring data. submitted data used for pesticide Shipman City Lake had one of the Following this evaluation, EPA again registration or reregistration. The values highest atrazine concentrations of the selected Shipman City Lake as the most used for soil properties and site lakes monitored. (Ref. 60 at 8). Two or appropriate reservoir to serve as a basis characteristics are chosen from real three of the other ARP reservoirs had for modeling. The other three best world databases appropriate for the sites slightly higher annual peak candidate reservoirs which were not on which the pesticide may be used. For concentrations but presented substantial selected were Springfield, Illinois example, if the pesticide is approved for modeling difficulties. (watershed too large for the model), use on cotton, OPP uses data reflecting The FIRST model was constructed in Gillespie, Illinois (two reservoirs used the soil types in the Cotton Belt. The a very similar manner to GENEEC. alternatively by the city) and index-reservoir being modeled is based FIRST assumes that up to a given Higginsville (reservoir has a pre-settling on and represents an actual, fairly percentage of a pesticide may run off basin which cannot be accurately typical, small flow-through reservoir into an adjacent drinking water modeled.) used for drinking water. Finally, the reservoir with the precise percentage iii. PRZM/EXAMS. The EPA PRZM weather inputs for the model are taken being a factor of the pesticide’s KD or and EXAMS models used together are a from site-specific weather data, based Koc value. After considering the more complex modeling system that on the USDA Major Land Resource concentrations of atrazine found in provide a more realistic estimate of Areas. PRZM modeling is generally Shipman City Lake and other ARP residue levels in surface water by simulated for 30 or 36 years in order to reservoir monitoring sites, atrazine’s KD incorporating more site-specific calculate the variability of the pesticide value, atrazine application rates, and information than GENEEC or FIRST. concentration in the surface water body various potential percentages of The PRZM component of the model is due to variations in weather over time pesticide runoff, EPA determined that, designed to predict the pesticide and the value used for risk assessment with a reservoir model, assuming that concentration dissolved in runoff waters is the 90th percentile value. up to 8% of the pesticide applied could and carried on entrained sediments Despite the fact that PRZM/EXAMS reach the reservoir was a conservative from the field where a pesticide has uses much greater site-specific (health protective) value. Like GENEEC, been applied into an adjoining edge-of- information than either GENEEC or FIRST assumes that a pesticide is field surface water body. The model can FIRST, it still provides high end or applied at its maximum application simulate specific site, pesticide, and upper bound estimates of pesticide rate. management properties including soil values in surface water. The high end/ Although FIRST, also like GENEEC, properties (organic matter, water upper bound estimates result from the assumes that all cropped area is 100% holding capacity, bulk density), site conservative manner in which PRZM/ treated with the pesticide in question, characteristics (slope, surface EXAMS selects and combines values

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derived from real world data. EPA EPA requested SAP review of the study found that ‘‘[s]imulations based intentionally chooses values for the appropriateness of using PCA and on the best choices for input parameters model which are likely not to presented the results of several (no conservatism built into parameters) underestimate the potential levels of modeling exercises using PCA in are generally within an order of pesticide residue in surface water. For connection with both PRZM/EXAMS magnitude of measured data with better example, the application rate and and GENEEC. Comparisons of these agreement observed both for larger frequency used in the model are the modeling exercises to monitoring data events and for cumulative values over highest allowed by the product label. In showed that in most cases, the models the study period.’’ Id. When simulations addition, PRZM/EXAMS modeling is overstated residues by an order of were run using conservative input assumed to be conservative because magnitude or greater. In other cases, the parameters such as employed by EPA, both the farm pond and index reservoir models overstated residues by factors according to the study, ‘‘substantial represent a vulnerable water supply; less than 10. Finally, in two instances, over-prediction of runoff losses occur.’’ conservative fate parameters are used in the models understated values found in Id. at 6, 8, 49. This conclusion regarding the model; 100% of the cropped area in vulnerable water bodies. over-prediction only considered the watershed is assumed to be treated The SAP generally endorsed the use estimated values at the edge of the field with pesticide; for all but four major of the concept of PCA for drinking water and did not take into account the crops (corn, soybeans, wheat, and models. (See Ref. 16 at 67). Further, the substantial conservatism introduced by cotton) 87% of the watershed is SAP concluded that ‘‘[u]se of the EPA’s assumptions regarding pesticide assumed to be cropped and treated; site maximum PCA appears to result in an application amount, the percentage of conditions (annual rainfall and soil) are appropriately conservative assessment the watershed receiving pesticide chosen to represent a site especially for most chemicals for major-use treatment, and the timing of application vulnerable to runoff taking into account compounds.’’ Id. The SAP, however, on adjacent fields. all of the sites on which the specific was skeptical of the conservativeness of EXAMS has also been the subject of crop is grown across the United States; the use of PCA with regard to minor extensive validation efforts. Satisfactory and the simulation is run for up to 36 crops. Id. at 68. This appears to have validation has been achieved in studies years and the results are reported at the been due to the fact that the two conducted in the Monogahela River, 90% highest year. For the crops corn, instances in which PRZM/EXAMS USA, an outdoor pond in Germany, a soybeans, wheat, and cotton, 46%, 41%, under predicted drinking water bay on the each coast of Sweden, 56%, and 20%, respectively of the concentrations involved minor crops. Japanese rice paddies, and rivers in the watershed is assumed to be cropped and Accordingly, EPA has used a default United Kingdom and South Dakota, treated. Further compounding the PCA value of 87% in conducting PRZM/ USA. (Ref. 6). The most important validation of tendency of these assumptions to EXAMS modeling for minor crops for these models is not the abstract study of overstate exposure, EPA also assumes drinking water assessments. Further these models but how well the models that all of the pesticide in the watershed examination of the two cases of under have worked in practice when used by is applied simultaneously using the prediction, however, suggest that not EPA in pesticide risk assessment. To do application method most likely to too much weight should be attached to such an evaluation, EPA compared its produce maximum runoff. Assuming these results. As to one of the cases surface water estimates from GENEEC, simultaneous application tends to (methomyl), the comparison was between PRZM/EXAMS modeling for FIRST, and PRZM/EXAMS to data on exaggerate residue estimates in drinking minor crop (lettuce and peaches) and pesticides in surface water compiled water because that means all potentially monitoring data on a major crop (corn). through the U.S. Geological Survey’s treated area in the watershed will have Further, the relatively higher National Water-Quality Assessment pesticide residues (from a maximum concentration value found in (NAWQA) Program. NAWQA is application applied with the technique monitoring was not from a drinking designed to provide ‘‘consistent and most likely to produce runoff) available water reservoir but a stream adjacent to comparable information on water when the next rainfall event occurs. a corn field. In the other case resources in 60 important river basins Assuming staggered application (methidathion), the monitored value and aquifers across the Nation.’’ (Ref. between growers would be more was from a river (the San Joaquim River 68)These river basins and aquifers realistic but data is not currently in California) that is largely composed account for approximately 60 to 70% of available that would allow that level of of irrigation return flow from the country’s water use. Id. EPA found sophistication in the model. All these agricultural fields. Such a river is 47 instances in which it had estimated factors lead to an assessment that generally not a drinking water source pesticide residues in surface water PRZM/EXAMS is expected to predict (the portion of the San Joaquim River resulting from the pesticide’s use on a high end or upper bound where the samples were drawn is not particular commodity using either concentrations. (Ref. 53 at 20-21). used for drinking water) and PRZM/ GENEEC (14), FIRST (3), or PRZM/ EPA sought SAP review of the PRZM/ EXAMS is not structured so as to EXAMS (30) and there was also EXAMS modeling system in 1995 as predict levels in such an environment. NAWQA data on the pesticide in part of the SAP’s review of the report Both the PRZM and EXAMS models surface water. (Ref. 41)See Table 6 entitled ‘‘Aquatic Dialogue Group have been the subject of extensive below. In each instance, the peak Report: Pesticide Risk Assessment and validations. The FIFRA Environmental modeled value exceeded the maximum Mitigation’’. The SAP was Model Validation Task Force recently value in the NAWQA data. In fact, in 42 complementary of this overall approach completed a review of PRZM. (Ref. 28). of the 47 cases, the modeling value was to exposure assessment modeling (See That study was an industry-sponsored nearly an order of magnitude or more Ref. 19 at 7-9). In addition, the PRZM/ calibration effort, but EPA scientists higher. This further confirms that EXAMS model has been before the SAP participated in the design and conduct reliable data support EPA’s conclusion in the context of the issue of the of the study. The study’s report that use of these surface water models introduction of incorporation of a concluded that PRZM ‘‘provides a is not likely to underestimate drinking ‘‘percent cropped area’’ [PCA] factor in reasonable estimate of chemical runoff water exposure. To the contrary, these OPP’s drinking water models. In 1999, at the edge of the field.’’ Id. at 6. The data confirm that these models produce

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conservative (health-protective), and often extremely conservative, results.

TABLE 6.—COMPARISON OF SIMULATION MODEL OUTPUTS WITH UPPER LEVEL NAWQA MONITORING VALUES

Peak Pesticide Model(s) Crop Modeled NAWQA NAWQA Value* 95th%ile Maximum

2,4-D FIRST Sugarcane 132.00 0.35 15(E)

2,4-D PRZM/EXAMS Apples 118.00 0.35 15(E)

Acetochlor PRZM/EXAMS Corn 284.00 0.17 25.1(E)

Acifluorfen PRZM/EXAMS Soybeans 14.00 <0.04 1.10

Alachlor GENEEC Corn/Soybeans 199.00 0.10 10.90

Aldicarb PRZM/EXAMS Citrus 2.03 <0.550 0.51(E)

Atrazine PRZM/EXAMS Sugarcane 205.00 2.86 201(E)

Azinphos methyl PRZM/EXAMS Peaches 16.00 <0.05 0.5(E)

Benfluralin PRZM/EXAMS Apples 61.00 <0.01 0.01

Bentazon PRZM/EXAMS Not given 122.00 0.15 8.60(E)

Bentazon GENEEC Not given 100.20 0.15 8.60(E)

Butylate GENEEC Corn 33.10 <0.002 1.40

Carbaryl PRZM/EXAMS Citrus 494.00 <0.041(E) 5.2(E)

Carbofuran PRZM/EXAMS Grapes 39.40 0.043(E) 7.00(E)

Chlorothalonil PRZM/EXAMS Tomatoes 43.80 <0.48(E) 0.29(E)

Chlorpyralid FIRST Canola 17.10 <0.230 <0.230

Chlorpyrifos GENEEC Sweet corn 56.50 0.01 0.26

Chlorpyrifos PRZM/EXAMS Sweet corn 40.60 0.01 0.26

DCPA PRZM/EXAMS Cabbage 160.00 0.02 100(E)

Diazinon PRZM/EXAMS Citrus 540.00 0.02 2.50

Dichlobenil GENEEC Turf 951.00 <1.2(E) 0.01(E)

Disulfoton PRZM/EXAMS Potatoes 15.51 <0.021 0.43

Diuron GENEEC Orchard 152.00 0.26 14(E)

EPTC PRZM/EXAMS Citrus 57.35 0.02 7.30

Ethalfluralin PRZM/EXAMS Sunflowers 2.27 <0.009 0.07

Ethoprop PRZM/EXAMS Sweet Potato 127.00 <0.005 0.45

Linuron PRZM/EXAMS Carrots 1.30 <0.035 1.40

Malathion PRZM/EXAMS Citrus 324.00 <0.027 0.52

Methomyl GENEEC Lettuce 409.00 <0.020 0.67

Methomyl PRZM/EXAMS Corn 60.00 <0.020 0.67

Metolachlor PRZM/EXAMS Corn 134.60 1.38 77.6(E)

Metribuzin GENEEC Sugarcane 390.00 0.05 6.61

Norflurazon GENEEC Cane Berry 72.10 <0.040 1.24

Norflurazon PRZM/EXAMS Citrus 396.00 <0.040 1.24

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TABLE 6.—COMPARISON OF SIMULATION MODEL OUTPUTS WITH UPPER LEVEL NAWQA MONITORING VALUES— Continued

Peak Pesticide Model(s) Crop Modeled NAWQA NAWQA Value* 95th%ile Maximum

Oxamyl GENEEC Pineapple 321.80 <0.020 0.16

Parathion GENEEC Cotton 166.00 <0.008 0.14

Pebulate PRZM/EXAMS Not given 2.90 <0.004 0.08

Propargite PRZM/EXAMS Cotton 34.30 <0.023 2.62

Propochlor GENEEC Sorghum 202.00 <0.010 0.51

Propochlor PRZM/EXAMS Sorghum 64.00 <0.010 0.51

Propyzamide (Pronamide) FIRST Ornamentals 390.00 <0.004 0.28

Tebuthiuron PRZM/EXAMS Pasture/Range 15.10 0.02 0.95

Terbufos PRZM/EXAMS Sorghum 21.70 <0.017 0.56

Thiobencarb GENEEC Celery 186.00 <0.005 3.66

Triallate PRZM/EXAMS Wheat 5.50 <0.001 0.65

Triclopyr GENEEC Pasture 364.00 <0.25 16(E)

Trifluralin PRZM/EXAMS Sugarcane 3.44 <0.009 0.17 * = 1-in-10 year peak value; (E) = NAWQA Estimate

A review of drinking water life, no reservoir dilution effects, and no • Soil site highly vulnerable to leaching assessments by the pesticide industry soil photolysis. Id. (very sandy, little clay, low organic matter). • Rainfall supplemented with irrigation to reached a similar conclusion. In this b. Ground water. As mentioned above, study, results from FIRST modeling ensure higher than average monthly rainfall EPA uses the SCI-GROW model for for each consecutive month of study. (conducted for the purpose of the study) estimating residues of pesticides in Supplementation of rain with irrigation errs and PRZM/EXAMS modeling (from EPA ground water. SCI-GROW is a regression on the side of greater opportunity for exposure assessments) were compared model that uses chemical-specific data encountering rainfall amounts in excess of with data from a USGS/EPA monitoring on a pesticide’s adsorption (i.e. the soil/ normal patterns. program.(Ref. 23). The monitoring data • Sites with shallow water tables. water partition coefficient of K or K was gathered from small drinking water D oc • Sites that represent an unknown but value) and the pesticide’s persisence reservoirs in areas with high pesticide very low percentage of the ground water used (i.e. the soil metabolism half-life) in use in 12 geographically disparate as drinking water. combination with the assumption that • Sites with wells totally surrounded by regions in the United States. The study the pesticide is being applied at its treatment area; no dilution with clean water. compared acute prediction values with • Sites with wells directly adjacent to the maximum value from the maximum application rate. The model is based on data obtained from ten treatment area; short path to well. monitoring data and the chronic • Maximum rate of pesticide application; prediction values with 95th percentile prospective monitoring studies multiple treatments may be applied as one of a time weighted average of monitored measuring the degree to which various massive application. values. The result was that ‘‘[f]or both pesticides leached to ground water. b. Development of SCI-GROW ignored acute and chronic exposure the models These studies were conducted in PGW [prospective ground water] studies with systematically overestimate measured hydrogeologically-vulnerable sites (i.e., no ground water detections; only those that shallow aquifers; sandy, permeable produced concentrations were included in exposure typically by 10 to 10,000 fold the regression data set. Therefore, SCI-GROW for the majority of cases.’’ Id. There was soils; and substantial rainfall or irrigation to maximize leaching). SCI- reflects a filtered data set that implies greater no instance in which a model frequency of observed concentrations than underestimated exposure. Id. The study GROW provides a screening value what actually occurred in the PGWs. concluded that the overestimation which is applied to both peak and Id. at 12. occurred due to ‘‘[c]ompounding chronic exposure screening. As with the surface water models, conservative assumptions, without In its review of the SCI-GROW model EPA has examined how well the models considering associated probabilities of in 1997, a majority of the SAP have worked in practice when used by occurrence/co-occurrence.’’ Id. The concluded that it was ‘‘highly EPA in pesticide risk assessment. To do conservative assumptions identified as conservative.’’ (See Ref. 18 at 10) The such an evaluation, EPA compared its most likely leading to this result are (1) SAP summarized the reasons for this ground water estimates from SCI-GROW maximum label rate application on the conservatism as follows: to data on pesticides in ground water highest percent cropped area in the a. SCI-GROW is based mainly on OPP compiled through the NAWQA United States; (2) reservoir immediately prospective ground water studies designed to program. Comparisons of the SCI-GROW bordered by treated field; and (3) maximize the opportunity for pesticides to screening model have been made to highest mobility, upper percentile half leach into ground water: various upper bound distributions (99.0,

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99.5, and 99.8 percentiles) rather than to percentile) of 0.006 ppm and 0.007 time as imidacloprid continues to leach the absolute maximum values in the ppm, respectively, compared to PRZM- into ground water; however, the level NAWQA data (as was done with the EXAMS and maximum NAWQA surface was not expected to increase surface water model). No higher water values of 324 ppm and 0.39 ppm, dramatically given that the levels seen percentiles were calculated because respectively. Additionally, tolerance at the 3 and 12 foot soil depths was 1.63 such calculation would not be values for malathion range from 0.1 ppb and 1.31 ppb, respectively. (Ref. 43) reasonable given the sample size. The ppm to 135 ppm with most values for Data from the California site is less reason for not using maximum values, agricultural crops either 4 ppm or 8 useful due to the fact that there appears as was done with surface water ppm. The other instance where a to have been very little ground-water evaluation above, is the difference in the monitored value exceeded the modeled recharge occurring during the course of nature of ground water and most surface value involved alachlor. There, SCI- the study as evidenced by the almost water sources sampled in the study. GROW predicted a value of 0.82 ppm complete lack of detection of the Surface water bodies sampled were and the monitored value was 1.2 ppm bromide tracer (applied concurrently generally streams, reservoirs, or lakes or a factor of 1.5x higher. Preliminary with imidacloprid) in ground water. The which represent a significant amount of results of comparisons with alachlor maximum combined residue of mixing of runoff water from a watershed concentration frequency distributions imidacloprid parent and degradates that may be tens or hundreds of square from other large scale surveys, including found in the suction lysimeters was 0.62 miles in area. Well water often is most those targeted for alachlor or at least for ppb at 633 days post application. The representative of pesticides leaching corn use areas (the major crop use for maximum combined imidacloprid from a much smaller geographic area. alachlor) are inconclusive with regard to residue in the ground water at the Furthermore, there is a significant risk the conservativeness of the SCI-GROW California site was 0.14 ppb found 149 that at least some individual wells in prediction. Id. EPA plans to look more days post application. EPA concluded any large sample will be severely closely at the data on alachlor to that low (sub-ppb) level contamination impacted by pesticides because of either determine if any adjustment of SCI- of potable ground water might occur in poor well construction (allowing direct GROW is warranted. Primarily needed this region following application to influx of pesticide residues from the for this are the completion of analysis of irrigated vegetable or fruit crops. Id. surface) or spillage from pesticide new monitoring data recently submitted Additionally, extensive ground water mixing/loading activities or leakage to support the registration of acetochlor monitoring data that has recently been from pesticide storage facilities. (which includes some very useful submitted from the New York State Contamination levels in individual concentration distribution information Department of Environmental wells can be much, much higher from for alachlor as well as two other corn Conservation, Division of Solid and Hazardous Materials for Nassau and these sources than would occur in herbicides) and the analysis of a large Suffolk Counties of New York includes ground water solely from maximum amount of additional ground-water data on imidacloprid. Nassau and agricultural applications of pesticides to monitoring for multiple pesticides Suffolk counties have ground water that the surface. The consequence of this is conducted by USGS in more recent is exceptionally vulnerable to pesticide that the highest values of pesticides phases of the long-term NAWQA contamination and have a long history observed in a large scale survey of project. EPA expects that any of a number of pesticides being banned ground water cannot be assumed to adjustment to SCI-GROW would be from use in these counties over the represent contamination from normal slight. iii. Imidacloprid-specific data. EPA years. This exceptional vulnerability to outdoor uses of pesticides. has received and reviewed two contamination is due to the very rapid EPA identified 39 instances in which prospective ground water studies for infiltration of pesticides that occurs in it had estimated pesticide residues in imidacloprid (Refs. 43 and 45). Such the sandy soils present in the ground water resulting from the studies are designed to measure agricultural areas of Long Island and the pesticide’s use on a particular maximum concentrations of pesticides tendency for pesticides to persist in the commodity using SCI-GROW and there likely to occur in ground water under ground water. These conditions have was also NAWQA data on the pesticide geological conditions vulnerable to been documented from many years of in ground water. (Ref. 42). In all but ground water contamination. The monitoring ground water in this area three instances, the peak modeled value studies were conducted in Montcalm (many of early detections for pesticides exceeded the 99.8th percentile value County, Michigan and Monterrey that were subject to scrutiny for ground- from the NAWQA data. No exceedances County, California. water contamination in the 1960s and occurred for any of the 39 compounds At the Michigan study site, 1970s were from Long Island. (Ref. 26). at the 99.5 percentile level or below. imidacloprid parent was consistently For imidacloprid, there have been Most estimates, even at the 99.8th detected in one of six monitoring well about 27 detections of imidacloprid percentile, were substantially above the clusters in the treated field beginning above a detection limit of 0.2 ppb in NAWQA value. For example, in 24 about 500 days after application and about 5,000 ground water samples taken cases, the modeling value was an order continuing through the close of the by the Suffolk County Department of of magnitude or more higher than the study some 5 years after application. No Health Services, to date, with much of 99.8th percentile NAWQA value. Of the degradation products were detected in the monitoring targeted to areas with three cases in which the monitoring ground water during this period (there known histories of imidacloprid use and value exceeded the projected value, in were a very few detections before previously documented ground-water each instance the difference was less application that may have been due to contamination issues. Overall, than a factor of 2x. In two of the three previous uses nearby or sample imidacloprid detections are rare in cases both the projected and monitored contamination). The maximum drinking water wells. Three wells had values were extremely low both concentration of imidacloprid parent detections above the model-predicted absolutely and relative to other detected in ground water in any one maximum of 1.4 ppb. After closer exposure values for the pesticide. For sample at the Michigan study site was investigation, however, EPA has example, malathion had SCI-GROW and 0.24 ppb. EPA concluded that the 0.24 concluded that those three wells are not NAWQA ground water values (99.8th ppb level might increase slightly over reliable indicators of imidacloprid

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values that can be expected in ground even the extraordinary and It should be emphasized that in water from agricultural use of unrepresentative values seen in ground objecting to EPA’s reliance on this imidacloprid. The first of these wells is water on Long Island as a result of scientifically designed consumption a private well in Mattituck, Long Island pesticide misuse, a direct connection survey, NRDC has offered nothing other in which imidacloprid was found at a between ground water and surface than speculation to support its claim level of 6.69 ppb. An investigation by water, or extremely shallow ground that EPA is underestimating blueberry the New York authorities, however, water. consumption. For this reason alone, concluded that these high levels were 5. Missing exposure data - specific— NRDC’s argument lacks merit. due to misuse of the pesticide in a a. Information on regional consumption. For the reasons detailed above, greenhouse adjacent to the well where NRDC contends that, for imidacloprid, NRDC’s allegations concerning imidacloprid contaminated water was EPA relied on estimates of national blueberry consumption do not indicate drained onto the ground in the consumption of blueberries and not that EPA has underestimated exposure immediate vicinity of the well. The regional or state-specific data for its of consumers in Michigan and New second well was one of five shallow granting tolerances in connection with Jersey to imidacloprid. NRDC’s monitoring wells installed directly the approval of emergency exemptions objection to the children’s safety factor down gradient from imidacloprid use under FIFRA for use of the pesticide on decision on this ground, therefore, is sites for the purpose of monitoring blueberries in the States of New Jersey without merit. pesticide levels. One of those wells, and Michigan. NRDC argues that the b. Residential exposure information. ‘‘Jamesport B-2’’, showed levels of fresh nature of the food and the NRDC claims that EPA failed to include imidacloprid as high as 2.06 ppb. It was potential for heavy local consumption several residential exposure scenarios in discovered, however, that this well was with a strong seasonal component its aggregate exposure estimate for in all likelihood contaminated as a strongly suggests that national imidacloprid based on low toxicity. result of a manmade sump nearby that consumption data may underestimate Imidacloprid Objections at 16. was constructed to alleviate ponding in consumption in localized areas in New Previously, EPA had concluded that the field and directly connected surface Jersey and Michigan. certain residential exposure scenarios water to ground water. Imidacloprid EPA is confident that the did not present any significant risk was detected in only one of the other methodologies used in its estimation of either because the toxicity data did not five wells, and the level of imidacloprid exposure and the percentile of reveal any relevant adverse effects for detected in the other well did not regulation selected do not the duration of exposure in question exceed 0.24 ppb. Finally, imidacloprid systematically underestimate exposures (intermediate-term exposure for all has been detected in shallow ground to major identifiable subpopulations. population groups) or because This is based, in part, on the extensive imidacloprid exposure was not expected water wells directly downgradient from food consumption survey data from for a particular population group (short- a site investigating use of tree injection USDA (its Continuing Survey of Food term adult exposure). See 66 FR at treatments of imidacloprid. The highest Intake by Individuals or CSFII) which 56229, 56231. On October 8, 2002, level of imidacloprid found in these surveyed more than 20,000 individuals however, the Health Effects Division wells was 3.9 ppb. These wells, from all States and results in more than (HED) Hazard Identification Assessment however, are not representative of wells 40,000 unique person-days of Review Committee (HIARC) re-reviewed used to supply ground water for consumption. EPA notes that, contrary the hazard and exposure database for drinking water. The wells were screened to the assertion by NRDC, consumption imidacloprid and established additional at extremely shallow depths (screens is not averaged throughout the year, but endpoints. Endpoints were chosen for beginning only 4 to 10 feet from surface) instead the CSFII includes each reported each of the following exposure due to the fact that the depth to ground consumption amount in the form of a scenarios: acute dietary, chronic dietary, water averaged about five feet. It was frequency distribution of actual reported short-term oral, intermediate-term oral, concluded that these wells are ‘‘no more single-day consumptions. Each short-term dermal, intermediate-term representative of what would likely individual consumption event thus can dermal, long-term dermal, short-term occur in drinking water supplies than be considered separately when such inhalation, intermediate-term pesticide concentrations in samples consideration is appropriate to risk inhalation, and long-term inhalation. taken from a weir draining an assessment as for risk assessments Additionally, it was concluded that agricultural field are representative of estimating acute risks. short-term exposure was likely for what would occur in a community Accordingly, the CSFII survey is adults by the dermal and inhalation water supply drawing from a river or adequate to capture the high-end route. Oral exposure for adults is not reservoir downstream.’’ (Ref. 43) consumers about which NRDC raises expected from the residential uses for iv. Conclusion. Based on the above concerns. The survey is statistically imidacloprid (e.g., turf, ornamental, analysis of EPA’s drinking water designed to be representative of the U.S. pets) because adults do not generally models, EPA concludes that they are population and reflects variability in engage in the type of hand-to-mouth based on reliable data and have consumption over all seasons and behavior that can produce such produced estimates that EPA can geographic regions. Due in part to this pesticide exposure in young children. reliably conclude will not design and the fact that fresh blueberries Accordingly, an aggregate risk underestimate exposure to pesticides in are widely available in season in states assessment for short-term dermal and drinking water. The model estimates where they are not grown, EPA does not inhalation exposure for adults was EPA used for assessing the aggregate believe that the high-end consumption conducted. 68 FR 61624, 61632 (October exposure to imidacloprid (37.6 ppb for estimates present in the USDA CSFII 29, 2003). Intermediate-term risk acute and 17.52 ppb for chronic from survey materially or systematically assessments (i.e. risk assessments that the FIRST surface water model) are underestimate the consumption patterns aggregate exposure from food, water, substantially higher than any actual data of consumers in blueberry-producing and residential exposures for on imidacloprid residues in drinking states (either overall or during harvest comparison to intermediate risk water including the imidacloprid and other ‘‘high-availability’’ seasons). endpoints) were not conducted because, prospective ground water study and (Ref. 52). based on residential application

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practices and the half-lives observed in a safety finding for a pesticide where Moreover, Congress made clear that it the turf transferable residue study, EPA has determined the dose in animals was adopting the reasonable certainty of residential exposures to imidacloprid at which no effects, adverse or no harm standard based on EPA’s are not expected to be continuous for otherwise, are elicited from exposure to ‘‘current application of the standard.’’ periods of 30 to 90 days. 68 FR at 61632; the pesticide. Isoxadifen-ethyl Since the passage of FFDCA section 409 (see Ref. 44 at 51). Objections at 17-18. Below EPA in 1958, both FDA and EPA have a long c. Prospective ground water identifies the flaws in NRDC’s generic history of applying that standard. In no monitoring studies. As discussed above, argument concerning LOAELs and instance, has either agency indicated these studies have been received and NOAELs and addresses the pesticide- that reliance on LOAELs, although it has reviewed. The levels of imidacloprid specific concerns NRDC raises with been an accepted practice generally, found in ground water were below the regard to use of a LOAEL as to (See Ref. 12) was barred by the levels from modeling used to calculate imidacloprid. reasonable certainty of no harm aggregate exposure. 1. Generic legal argument. EPA standard. To the contrary, EPA has 6. Missing risk assessment. NRDC believes that it can make a reasonable relied on LOAELs to make reasonable claims that a short-term residential risk certainty of no harm finding based on a certainty of no harm findings under assessment is missing as to LOAEL from an animal study (where no section 409. (See 61 FR 33041 , 33042 imidacloprid. Imidacloprid Objections NOAEL was found) in appropriate (June 26, 1996) (establishing food at 5. EPA would note, however, that circumstances. Whether or not a additive regulation for flutolanil); 55 FR such a risk assessment was conducted reasonable certainty of no harm finding 23736 (June 12, 1990) (establishing food and is summarized on pages 39,046 and can be made when only a LOAEL is additive regulation for pirimphos 39,047 of the Federal Register notice. 67 identified in a study depends on methyl). In fact, FDA and EPA FR 39041, 39046-39047 (July 21, 1999). whether EPA has sufficient toxicological interpreted the reasonable certainty of See also 68 FR 61624, 61632 (October evidence to estimate with confidence a no harm standard to permit a safety 29, 2003). projected NOAEL that is unlikely to be finding to be made in circumstances 7. Conclusion on children’s safety higher than the actual NOAEL. where a NOAEL cannot be identified - factor issues. In the challenged Typically, when a LOAEL but not a that is, when a substance is believed not tolerance action, EPA applied an NOAEL has been identified by a study, to have a threshold below which no additional safety factor of 3X to address EPA will, when the data support it, adverse affect will result - and the the missing DNT study. As discussed project a NOAEL for that study by House Commerce Committee in its above, that study has now been received dividing the LOAEL by a factor, usually Report on the FQPA specifically and reviewed. Taking into account the 3X. recognized and approved that approach. results of that study as well as all of the There is nothing in the statutory Id. Thus, the legislative history, if arguments raised by NRDC, EPA has safety standard explicitly addressing the anything, supports the proposition that concluded that there are reliable data use of NOAELs or LOAELs. Moreover, a LOAEL may provide a sufficient basis supporting removal of the additional nothing in the phrase ‘‘reasonable for a reasonable certainty of no harm safety factor for infants and children for certainty of no harm’’ legally precludes all risk assessments other than the acute finding. use of LOAELs to make a finding EPA also rejects NRDC’s argument risk assessment relying on the acute regarding the likelihood that harm will that a safety finding for a threshold neurotoxicity study in rats to project a occur at a given dose. Whether a LOAEL effect can only be made based on a ‘‘no safe dose in humans. As to the acute provides a sufficient basis for a observed effect level’’ (NOEL) as risk assessment using the acute reasonable certainty of no harm finding opposed to a ‘‘no observed adverse neurotoxicity study in rats, there are is a question of scientific fact. effect level’’ (NOAEL). EPA’s Office of reliable data supporting use of an NRDC correctly notes that the House Pesticide Programs (‘‘OPP’’) in a additional 3X factor instead of 10X. See Commerce Committee indicated that its response to comment document has Unit VII.C.2. The 3X safety factor has ‘‘expect[ation]’’ was that EPA would be explained the Agency’s reasoning. been incorporated into the acute risk able to make a reasonable certainty of no Although noting the House Commerce assessment by dividing the LOAEL from harm finding where there was an ample Committee Report uses the term the acute neurotoxicity study by 3 in margin of safety between exposure ‘‘NOEL’’, OPP concluded that: deriving the acute reference dose. levels and - the legislative history does not indicate C. LOAEL/NOAEL the level at which the pesticide chemical that Congress intentionally used the term residue will not cause or contribute to any NOEL because it did not think it appropriate NRDC argues that EPA cannot legally known or anticipated harm to human health. for OPP to consider the NOAEL. H. Rept. make the reasonable certainty of no The Committee further expects, based on 104-669, 104th Cong., 2d Sess. 41 (1996). In harm finding for imidacloprid because discussions with the Environmental fact, Congress appears to have assumed EPA has relied on a LOAEL in assessing Protection Agency, that the Administrator NOELs are NOAELs. For example, in the safe level of exposure to the will interpret an ample margin of safety to be defining ‘‘threshold effect’’ Congress stated a 100-fold safety factor applied to the pesticide. NRDC claims EPA ‘‘cannot that this ‘‘is an effect for which the scientifically determined ‘‘no observable Administrator is able to identify a level at lawfully establish tolerances in the effect’’ level when data are extrapolated from which the pesticide chemical residue will absence of a no-observed-effect-level animal studies. not cause or contribute to any known or (NOEL).’’ Imidacloprid Objections at 18. H. Rep.104-669, pt. 2 , 41 (1996). anticipated harm to human health.’’ Id. Implicit in this argument is that EPA Congress’ expectation, however, that a (emphasis added). If Congress had intended cannot use a no-observed-adverse-effect- reasonable certainty of no harm finding that threshold effects be based on NOELs level (NOAEL) in making a safety could be made under one set of rather than NOAELs, it would not have used finding. In later objections, NRDC circumstances (100-fold safety factor the word ‘‘harm’’ in defining the effect. confirmed that in fact it was contending applied to the ‘‘no observable effect’’ Congress seems to have used the term NOEL because it was common usage for OPP that section 408’s safety standard does level), certainly does not preclude the at the time FQPA was passed. However, prior not permit EPA to rely on a NOAEL in finding being made in a different set to 1998, in OPP’s discussion of the hazard concluding a tolerance is safe. Rather, (e.g., 300-fold safety factor applied to identification process of evaluating pesticide according to NRDC, EPA may only make the lowest observable effect level). toxicity, the term NOEL was used to describe

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the dose level at which no significant adverse imidacloprid. Imidacloprid Objections Although there is some ambiguity as to effects were noted. OPP’s terminology was at 18. NRDC is mistaken as to chronic precisely how the factors listed in not consistent with the rest of the Agency, as toxicity. In assessing chronic risk, EPA section 408(b)(2)(D) relate to the safety illustrated in EPA’s Integrated Risk set the RfD using the NOAEL of 5.7 mg/ Information System (IRIS). This system finding described in section included more hazard terms than OPP kg/day based upon thyroid effects at the 408(b)(2)(A)(ii), for the reasons set forth generally employed, including NOAEL, next highest dose of 16.9 mg/kg/day in below, NRDC’s interpretation of the LOAEL, and FEL (Frank Effect Level). On the imidacloprid combined chronic/ statutory language is unreasonable. September 2, 1998, this apparent semantic carcinogenicity study in rats. 64 FR NRDC argues occupational exposures inconsistency was eliminated by HED 39041, 39044 (July 21, 1999); see must be considered because the general Standard Operating Procedure (SOP) 98.3 Imidacloprid Risk Assessment at 26, safety standard as set forth in section which indicated that OPP would commence Table 4. The acute toxicity endpoint 408(b)(2)(A)(ii) describes ‘‘aggregate using the terms NOAEL and LOAEL in their was based upon a LOAEL of 42 mg/kg/ scientific reviews and documents. It also exposure’’ broadly without any stated, ‘‘In a practical sense, the terms NOEL day from an acute neurotoxicity study in rats. This value was adjusted with a exclusion for occupational exposures. and NOAEL have been used interchangeably This reading, however, renders section in OPP. As a general rule, OPP would safety factor of 3X to approximate the consider as appropriate for hazard value of a NOAEL. EPA has high 408(b)(2)(D)’s limitation of aggregate identification and risk assessment only those confidence that this value of 3X is exposure to ‘‘non-occupational’’ effects which are adverse or potentially sufficient for several reasons. First, the exposures without effect. Three adverse. This inclusion of the term NOAEL LOAEL (42 mg/kg) from the acute important principles of statutory should not change any of our hazard neurotoxicity study is comparable to the construction suggest that such an endpoints for regulation but add to the approach is insupportable. First, the quality of the risk assessment.’’ LOAELs seen in adults in the (Ref.47 at 165-166) developmental rat study (30 mg/kg/d) language in the statute should be NRDC claims that only by relying on and the two-generation reproduction construed in a manner that accords a NOEL can the Agency legally make the study (47/52 mg/kg/d (male/female)) meaning to all provisions. United States required reasonable certainty of no harm and in the offspring in the DNT study v. Menasche, 348 U.S. 528, 538-539 finding. Isoxadifen-ethyl Objections at (55 mg/kg/d). Second, the extrapolated (1955) (‘‘It is our duty to give effect, if 17-18. Yet, NRDC’s legal argument here NOAEL of 14 mg/kg (42/3 = 14) is possible, to every word, clause and both ignores the language of the statute comparable to the NOAEL of 20 mg/kg/ sentence of a statute.’’) It is not lightly and relies on unsupported factual d established in the offspring in the presumed that Congress enacted a generalities. NRDC asserts use of a DNT. Importantly, the LOAEL in DNT meaningless or superfluous provision. NOEL is required because only by use study like the acute neurotoxicity study Asiana Airlines v. FAA, 134 F.3d 393, of a NOEL is ‘‘the risk assessor [] was based on decreased motor activity, 398 (D.C. Cir. 1998) (‘‘A cardinal assured that regulatory decisions are and the DNT established a clear NOAEL principle of interpretation requires us to based on a dose at which no effect is for that effect. Finally, the neurotoxic construe a statute ‘so that no provision elicited.’’ Isoxadifen-ethyl Objections at effects on motor activity in the acute is rendered inoperative or superfluous, 17 (emphasis added). The statute, neurotoxicity study showed a good dose void or insignificant.’’’). EPA’s however, defines the safety standard in response which resulted in minimal interpretation gives meaning to the terms of protecting against ‘‘harm,’’ not effects on motor activity and locomotor occupational exposure exclusion in ‘‘effects.’’ NRDC also argues that the activity at the LOAEL. section 408(b)(2)(D). Second, and ‘‘adverse’’ effects used to define D. Aggregate Exposure similarly, statutory language should be NOAELs are ‘‘crude toxicological construed in a harmonious fashion to 1. Worker exposure. EPA has endpoints,’’ and that ‘‘a NOAEL may the greatest extent possible. Citizens to represent a dose high enough to elicit interpreted ‘‘aggregate exposure’’ to pesticide residues not to extend to Save Spencer County v. EPA, 600 F.2d significant unpleasant and harmful 844, 871 (D.C. Cir. 1979) (‘‘[T]he effects . . . .’’ Id. NRDC, however, pesticide exposure occurring at the workplace based on the language in maximum possible effect should be provides no data or explanation to afforded to all statutory provisions, and, support such assertions. EPA believes it section 408(b)(2)(D) explaining what exposures are included in the term whenever possible, none of those applies the NOAEL standard in a way provisions rendered null or void.’’) that takes into account sensitive ‘‘aggregate exposure:’’ ‘‘The cardinal principle of statutory indicators of adverse effects. EPA’s use [T]he Administrator shall consider, among construction is to save and not to of cholinesterase inhibition as an other relevant factors . . . available destroy.’’ Menasche, 348 U.S. at 538. adverse effect is only one example of information concerning the aggregate exposure levels of consumers (and major Although EPA’s interpretation does not this. (Ref. 50). In any event, general identifiable subgroups of consumers) to the relieve all potential tension between claims about the non-protectiveness of pesticide chemical residue and to other NOAELs are insufficient to contest a section 408(b)(2)(A)(ii) and section related substances, including the dietary 408(b)(2)(D), NRDC’s approach treats the specific finding of safety by EPA. An exposure under the tolerance and all other objector must explain why the specific tolerances in effect for the pesticide chemical two sections as directly contradictory, safety finding, taking into account its residue, and exposure from other non- negating the specific language in component parts (e.g., the NOAEL or occupational sources . . . . subsection (b)(2)(D)(vi) pertaining to LOAEL identified, the safety factors This language quite plainly directs EPA occupational exposure. Third, specific used), does not provide a reasonable to limit consideration of aggregate language should control over general. certainty of no harm. NRDC has not exposure of pesticide residues and other Ohio Power Co. v. FERC, 954 F.2d 779, even attempted to make this case with related substances to those exposures 784 (D.C. Cir. 1992) (‘‘Of course, it is regard to the NOAELs used in making arising from non-occupational sources. black letter law that when a conflict the safety finding for imidacloprid. NRDC’s claim that EPA erred by not arises between specific and general 2. Use of LOAELs to assess considering worker risks in making provisions of the same legislation, the imidacloprid risk. NRDC asserts that tolerance decisions under section 408 courts should give voice to Congress’s EPA relied upon a LOAEL in assessing runs afoul of Congress’ explicit mandate specific articulation of its policies and both acute and chronic toxicity to that such exposures not be included. preferences.’’) Hence, the more detailed

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explanation in section 408(b)(2)(D) the employer. These cases have held involved in agriculture. Isoxadifen-ethyl concerning the scope of aggregate that the bar to seeking a tort remedy Objections at 11-12. NRDC claims these exposure should be relied upon to help against the employer applies only to children comprise a ‘‘major’’ subgroup to provide a harmonious construction of ‘‘employees’’ and an in utero fetus is not citing statistics showing that ‘‘320,000 the two sections. an employee. See, e.g., Snyder v. children under the age of six live on NRDC, pointing to the ‘‘among other Michael’s Stores, Inc., 945 P.2d 781 farms in the United States[], . . . many relevant factors’’ language in section (Calif S.Ct. 1997). hundreds of thousands of children play 408(b)(2)(D), objects that this section Although the statutory language on or attend schools on or near agricultural should not be viewed as controlling this issue may permit multiple readings land, . . . [and] [t]he nation’s 2.5 million because this section is intended to be here, EPA believes it is reasonable to farm workers have approximately one ‘‘illustrative’’ and not ‘‘exhaustive.’’ exclude workplace exposures to the in million children living in the United EPA fully agrees that section utero fetus from aggregate exposure. States.’’ Id. 408(b)(2)(D) was not intended to list EPA is not suggesting that the fetus is Whether or not EPA attaches the label exhaustively all of the considerations an employee - the issue involved in the ‘‘major identifiable subgroup’’ to farm appropriate to making safety worker compensation cases cited by children, EPA’s risk assessment determinations under section 408, but NRDC. The language of section 408 is approach to children, including the cannot accept the proposition that the significantly different than worker major identifiable subgroups of children ‘‘other relevant factors’’ language compensation statutes. Section 408 does used in its risk assessments, adequately somehow undoes the express limitation not bar consideration of exposure to takes into account any pesticide in subsection (b)(2)(D)(vi) concerning ‘‘employees’’ but rather exposure from exposures to children - whether as a occupational exposure. Not only does ‘‘occupational sources.’’ Given this result of living close to agricultural NRDC’s approach once again fail to give statutory language EPA believes it is areas or otherwise. For some time, EPA meaning to the occupational exposure reasonable to focus upon whether the has treated infants and children grouped exclusion in subsection (b)(2)(D)(vi) but exposure is principally due to exposure by ages (e.g., infants younger than 1 it fails to take into account Congress’ in an occupational setting or not. An year, children 1 - 2 years) as major directive that EPA could consider exposure to a fetus that results from the identifiable subgroups. These age ‘‘other relevant factors.’’ When used in fetus’ mother’s presence in an groupings have been chosen to reflect this fashion, the word ‘‘relevant’’ occupational setting would fall well different eating patterns of the age restricts EPA to considering factors that within this approach. This groups. In evaluating exposure to these are relevant to the safety determination interpretation also makes sense in terms or any other subgroup, however, EPA under section 408(b) - that is, relevant of the overall statutory scheme. considers the range of exposures across to whether a pesticide’s aggregate Presumably, Congress excluded the subgroup not just as a result of exposure meets the reasonable certainty occupational exposures from section pesticide residues in food but from all of no harm test. Presumably, Congress 408 because it determined that non-occupational exposures. If a provided an important reference point acceptable levels in food for the general significant number of any of the for determining relevance by the long public should not be set using the population subgroups of children have list of factors it required that EPA discrete, and highly regulated higher exposures due to a non-food consider. Relevance, moreover, is (including regulation by EPA under source (e.g., residential uses of a indicated not only by the factors that FIFRA), exposures occurring in the pesticide, proximity to agricultural Congress included but by the aspects of workplace as an assumed underlying areas), EPA believes that that exposure those factors that Congress expressly exposure. If occupational exposure to is appropriate to consider in evaluating directed were not to be considered. pregnant women is included in the range of exposures for the subgroup. Thus, EPA believes that Congress, by aggregate exposure under section 408, The fact that the children in the excluding occupational exposures from however, occupational exposure will subgroup receiving the higher exposures the term ‘‘aggregate exposure’’ in invariably be an aspect of the section are not themselves labeled a major subsection (b)(2)(D)(vi) was, in effect, 408 safety finding for pesticides identifiable subgroup in no way lessens determining the relevance of involved in agriculture or other EPA’s consideration of their exposures. occupational exposure to aggregate commercial enterprises because EPA This approach is nicely illustrated by exposure and the safety determination would generally have to assume that the imidacloprid risk assessment. under section 408. pregnant women may be in the In the imidacloprid risk assessment, Finally, NRDC has argued, in a workforce. EPA not only considered imidacloprid Petition which it has appended to its 2. Classification of farm children as a exposure from food but also exposures objections, that even if worker exposure major identifiable population subgroup. resulting from use of imidacloprid on generally is excluded from aggregate NRDC points out that FFDCA section lawns and pets. The residential use exposure, ‘‘in utero’’ exposures resulting 408 directs EPA to consider not just the scenario that produced the highest from the presence of pregnant women in general population in assessing estimate of exposure was a toddler the workplace should not be excluded aggregate exposure but also ‘‘major hugging the pet right after imidacloprid from consideration. NRDC, Petition for identifiable subgroups of consumers.’’ treatment. In evaluating aggregate a Directive that the Agency Designate 21 U.S.C. 346a(b)(2)(D)(vi). In this exposure to toddlers (children 1-2 years- Farm Children as a Major Identifiable regard, NRDC argues that children living old), EPA aggregated imidacloprid Subgroup and Population (1998). NRDC in agricultural communities should be exposure from the pet hug scenario with points to the statutory language treated as such a major identifiable imidacloprid exposure from food and directing EPA to consider ‘‘in utero’’ subgroup. These children are an water. This was done even though (1) exposures and cases under state worker identifiable subgroup, according to children living with pets capable of compensation statutes that have held NRDC, because of the allegedly receiving a full body hug are not that children who are injured ‘‘in utero’’ heightened exposure to pesticides that designated a major identifiable as a result of their mother’s employment they receive due to their proximity to subgroup; (2) it is likely that only a are not barred by worker compensation farm operations and farm land and, for minority of the children in the age schemes from bringing an action against some, due to their contact with parents subgroup of 1-2 years-old live with pets

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of this size; and (3) the number of 1-2 applications. These aspects of the report identifying farm children as an year-old children that may actually run counter to NRDC’s suggestions that: additional major identifiable subgroup experience the exposures estimated by (1) farm children are a major subgroup of consumers. EPA’s approach, the pet hug scenario is likely to be that receives greater exposure than non- described above, of examining the range exceeding small. Similar to the manner farm children; and (2) farm children are of exposures in each of the age-based in which residential exposure was a major identifiable subgroup, in that subgroups of children is adequately incorporated in the aggregate exposure the lines in the report between farm area protective of children to the extent they assessment, if EPA had information children and non-farm-area children experience higher exposures from showing meaningful exposure to exposed to agricultural spray drift are proximity to agricultural areas. children as a result of living close to blurred. 3. NRDC’s 1998 petition on farm agricultural areas, those exposures In addition, although in places the children. As previously mentioned, would receive full consideration in CFPR Report cites to studies NRDC petitioned EPA in 1998 to assessing aggregate exposure to the purportedly showing that farm children designate farm children as a major existing children’s subgroups. Thus, the suffer more exposure to pesticides than identifiable subgroup under section 408 fact that EPA has not labeled farm other children, on account of spray drift, and take several other various steps children as a major identifiable it largely relies on the Washington State regarding farm children’s exposure to subgroup has not in any way affected studies discussed above. For reasons pesticides. For the reasons stated above, EPA’s consideration of exposures that already mentioned, the Agency does not EPA does not believe it is appropriate to are unique to farm children. For the believe that those studies support the designate farm children as a major reasons discussed in the Units VII.A. designation of farm children as a major identifiable subgroup although, as and VII.D.4, however, EPA concludes identifiable subgroup. indicated, EPA will consider reliable that its exposure assessment has The Ranking Study, for its part, also data on the range of pesticide exposures adequately considered any potentially emphasized that ‘‘an increasing number received by children, including data greater exposures to children in of children live along the nation’s pertaining to such issues as spray drift, agricultural areas. agricultural-urban edge.’’ As discussed volatilization, and farmworker take- That being said, EPA does not believe above, this phenomenon clouds the home exposures that were raised by the that NRDC has made an adequate case potential for a distinction between farm 1998 petition. that the group of children NRDC and non-farm children. Moreover, the The 1998 petition also requested that designates as ‘‘farm children’’ are an authors of the study identified EPA: (1) retain the additional 10X safety identifiable group. Many of the ‘‘[n]otable uncertainties’’ in their risk factor for the protection of children commenters protested NRDC’s assessment, and would go only so far as where EPA lacks data on farm children designation of ‘‘farm children’’ as a to suggest that ‘‘farmworker/farm exposure; (2) make specific major identifiable subgroup, noting the children’’ constitute a subgroup determinations as to the exposure of heterogeneous nature of the group and ‘‘potentially at higher risk.’’ Thus, it, farm children from all pathways; (3) NRDC’s lack of precision in defining the too, fails to support the identification of require data from registrants where data group. To be sure, NRDC’s suggested farm children as a major identifiable is lacking on farm children’s exposure subgroup is constructed differently than subgroup, as distinguished from and not issue a tolerance until such data EPA’s historical practice with regard to children generally. is submitted; (4) refuse to register a new population subgroups. That practice has NRDC also alleges that farm children pesticide unless a validated scientific focused on categorizing individuals by have ‘‘unique . . .sensitivities to method is available to detect residues of age, ethnicity, and region of the country. exposure’’ that must be considered by the pesticide in food; (5) increase Similarly, NRDC is, in fact, far from EPA. Imidacloprid Objections at 11-12. research into exposures and health precise in defining the limits of the NRDC, however, cites no unique status of farm children; and (6) honor suggested subgroup. For example, NRDC toxicological sensitivities of farm the Executive Order on environmental does not clarify whether urban or children but rather focuses on the justice. suburban children on the borders of allegedly unique exposure patterns of As explained above, EPA has initiated areas that exist side-by-side with farm children. At most, NRDC points to a myriad of different research and agricultural areas should be included in the fact that children generally may be outreach programs concerned with the alleged subgroup, or whether it more toxicologically sensitive than pesticide exposure to farmworkers and would include in the subgroup children adults because their internal organs and their families. The most important of in agricultural areas who might live no bodily processes are still developing. Id. these include, on the research front, closer to application sites than some at 13. But the fact that children may EPA work with the National urban or suburban children. have different toxicological sensitivities Agricultural Workers Survey (NAWS), Moreover, several of the reports than adults does not support any claim and the Agricultural Health Survey submitted by NRDC undermined its regarding differences in sensitivities (AHS). In terms of outreach, EPA has contention that farm children are an between children generally and farm many ongoing programs, but would like identifiable subgroup based on children. to highlight two projects in particular. exposure. The CFPR Report, for In sum, the above studies and The Agency’s work with the Association example, in a number of places information, whether concerning of Farmworker Opportunity Programs highlights the degree to which, not only children in agricultural areas and non- (AFOP), and its work on the National farm-area residents, but also urban and agricultural areas or children in Strategies for Health Care Providers: suburban residents are exposed to agricultural areas alone, and whether Pesticide Initiative. pesticides. The asserted exposures concerning environmental levels, Through the Agency’s cooperative suffered by urban dwellers, moreover, biological levels, or both, provide no agreement with the Association of include spray drift not only from urban sufficient basis for designating ‘‘farm Farmworker Opportunity Programs area applications (e.g., from home and children’’ as a major identifiable (AFOP), EPA funds the National garden applications, as well as other subgroup. It thus was reasonable for Pesticide Safety Education Program for structural applications), but long-range EPA to assess aggregate exposure to the agricultural workers and farm worker spray drift from agricultural area challenged pesticide tolerances without children. Working with Americorps

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members, AFOP trains 25,000 farm children to imidacloprid generally identified the following subgroups: workers and farm worker children every (including both farm children and non- nursing infants (0-6 months); non- year about pesticide safety using farm children), through its assessment nursing infants (6 months - year); 1-2 Americorps members in over 50 sites in of exposure through food, drinking year-olds; etc. EPA evaluates each of 16 states. AFOP conducts pesticide water and residential use pathways. In these subgroups to determine if it can be safety training for children at childcare support of its objection to this determined that there is a reasonable centers, schools, churches, and assessment, NRDC cites numerous certainty of no harm for individuals in community centers, and has developed studies for the proposition that other these subgroups. (See Ref. 48 at 46 and a handbook in Spanish. The National pathways (e.g., track-in) increase farm Ref. 51 at 14) Strategies for Health Care Providers: children’s exposures, and it also cites b. Choice of population percentile. Pesticide Initiative is an initiative information purportedly suggesting that NRDC asserts that EPA erred by created by the EPA and the National volatilization and spray drift lead to allegedly making its safety decision as Environmental Education and Training higher exposures among farm children. to the acute risk posed by imidacloprid Foundation (NEETF) in collaboration For reasons discussed above, however based on only a portion of the with the U.S. Departments of Health and (see Unit VII.A.), EPA does not believe population, leaving the rest of the Human Services, Agriculture and Labor. that this information demonstrates that population unprotected. According to It is aimed at incorporating pesticide the pathways asserted, to the extent they NRDC, EPA only considered 95% of the information into the education and exist, lead to farm children experiencing affected population. EPA admits using practice of health care providers. The imidacloprid exposure levels higher the population percentage cited by goal is to improve the recognition, than those experienced by other NRDC in estimating acute exposure for diagnosis, management, and prevention children. Rather, these studies are imidacloprid. EPA most definitely was of adverse health effects from pesticide inconclusive, and suggest that farm not, however, acting in a manner exposures. This initiative also serves as children and non-farm children designed to only protect 95% of the a model for broader efforts to educate generally receive similar levels of population. To the contrary, EPA’s health care providers about the exposure. Nor does the information exposure estimates were designed to spectrum of environmental health bearing on volatilization and spray drift capture the full range of exposures in issues. Seven federal agencies and 16 demonstrate that farm children receive each population subgroup. professional associations of health care greater imidacloprid exposures through As explained in its science policy providers were involved in launching these two additional pathways. For paper on this subject, EPA, in estimating this initiative. These actions address the example, as stressed above, acute exposure for population Petition’s request regarding increased imidacloprid exposures due to subgroups, generally considers various research and fidelity to the Executive residential and pet uses common to population percentiles of exposure Order on Environmental Justice. farm and non-farm areas would dwarf between 95 and 99.9, depending on the EPA agrees that where additional data any exposures that might be attributable extent of overestimation in the residue are needed to characterize farm to either volatilization or spray drift in data used in the assessment.(See Ref. children’s exposure to a specific agricultural areas. pesticide it will retain the additional 5. Residential exposure as a result of 52) In each exposure assessment EPA is 10X safety factor unless reliable data use requiring a tolerance. NRDC also attempting to reasonably estimate the exist that support selection of a different argues that EPA has erred in not full range of exposures in a subgroup. safety factor. Further, EPA will seek including the added residential The use of a particular percentile of additional data on farm children exposure that occurs in the home when exposure is a tool to estimate exposures exposure where necessary. Any decision an additional agricultural use is added. for the entire population and population on whether to approve a tolerance The reasons explained above as to why subgroups and not a means to eliminate where additional data has been required any additional exposure to children as protection for a certain segment of a will have to be a case-by-case a result of their proximity to farming subgroup. When inputs for pesticide determination considering other data operations is expected to be residue values in the exposure estimate that is available on the pesticide and the insignificant as regards imidacloprid are high end (e.g., assuming all food ability of use of additional safety factors apply with equal or more force as to this contains tolerance level residues), a to address any uncertainty raised by the contention. lower percentile of exposure (e.g., 95%) requested data. As to making specific 6. Population percentile used in is thought to be representative of findings on all possible pathways of aggregate exposure estimates—a. In exposure to the overall population as exposure to farm children, EPA will general. NRDC contends that EPA in well as subgroups. As increasingly follow a pesticide-specific approach making the reasonable certainty of no realistic residue values are used (e.g., which considers both the generic harm finding must make such a finding information from pesticide residue information and pesticide-specific as to ‘‘all children’’ - that is, EPA must monitoring), a higher percentile of information in regards to whether a find that ‘‘no children will be harmed’’ exposure (e.g., 99.9%) is generally particular pathway has the potential for by exposure to the pesticide. Although necessary to be protective of the overall significant exposure. Finally, EPA EPA is somewhat uncertain as to population and its subgroups. agrees that it should not register a new precisely what approach to risk This issue was the subject of some pesticide for use on food unless it has assessment and safety findings NRDC is attention when EPA began performing approved an analytical method for advocating, EPA believes that its probabilistic acute exposure (risk) detecting the level of pesticide residues approach to implementing the assessments using monitoring data for in food or found that such a method is reasonable certainty of no harm residue values and increasingly used a unnecessary. standard is consistent with the statutory population percentile of 99.9 to estimate 4. Adequacy of EPA’s assessment of framework. As specified in the statute, exposure. Some affected parties became the aggregate exposure of children, EPA focuses its risk assessment and concerned that EPA was determining including children in agricultural areas. safety findings on major identifiable that only 99.9% of the population were EPA believes that it has adequately population subgroups. 21 U.S.C. entitled to protection from potentially assessed the aggregate exposure of 346a(b)(2)(D)(vi). For children EPA has unsafe pesticide residues. EPA

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addressed this issue in a policy paper, calculating aggregate exposure for ‘‘emergency condition exists.’’ 40 CFR noting that: imidacloprid is in violation of the 166.25(b)(1)(i). An ‘‘emergency just as when OPP uses the 95th percentile requirements specified in section condition’’ is defined as ‘‘an urgent, with non-probabilistic exposure assessments 408(b)(2)(F). That section imposes non-routine situation . . . .’’ 40 CFR OPP is not suggesting that OPP is leaving 5% certain conditions upon EPA’s use of 166.3(d). The regulations deem an of the population unprotected, OPP is not by percent crop treated data when emergency condition to exist when (1) choosing the 99.9th percentile for assessing chronic dietary risk. Among no effective, registered pesticides are probabilistic exposure assessments concluding that only 99.9% of the population the specified conditions are the available to address the conditions; (2) deserves protection. Rather, it is OPP’s view requirements that EPA find that ‘‘the ‘‘no economically or environmentally that, with probabilistic assessments, the use data are reliable and provide a valid feasible alternative practices which of the 99.9th percentile generally produces a basis to show what percentage of the provide adequate control are available;’’ reasonable high-end exposure such that if food derived from such crop is likely to and (3) the situation will cause that exposure does not exceed the safe level, contain such pesticide chemical residue ‘‘significant economic loss . . . .’’ Id. OPP can conclude there is a reasonable . . . [and] the exposure estimate does not Applicants for emergency exemptions certainty of no harm to the general understate exposure for any significant are required to submit information to population and all significant population subpopulation group . . . .’’ 21 U.S.C. EPA addressing these issues. 40 CFR groups. 346a(b)(2)(F). NRDC claims that, 166.20. EPA may ‘‘discontinue Id. at 31. because EPA used national percent crop processing’’ of incomplete applications, Other parties had the opposite treated data on blueberries even though 40 CFR 166.30(a)(1), and deny an concern - namely, that by using the 99.9 imidacloprid use on blueberries is only application for a information gap but percentile EPA was grossly overstating permitted in Michigan and New Jersey, must reconsider the application when exposure to the population. EPA had no ‘‘valid basis’’ for projecting the information gap is filled. 40 CFR Interestingly for the purpose of the the percent crop treated in those two 166.30(a)(2). NRDC’s claims regarding imidacloprid, states. Additionally, NRDC argues that EPA first approved the State of EPA’s analysis of the reasonableness of use of national percent crop treated data Michigan’s request for an emergency its exposure assessments demonstrated on blueberries will ‘‘understate exemption for the use of imidacloprid that exposure estimates using high end exposure’’ for the significant population on blueberries in July, 2001. The residue values and the 95th percentile group of blueberry consumers in problem faced by growers in Michigan of exposure were significantly greater Michigan and New Jersey. was that the Japanese beetle (an invasive than exposure estimates for the same NRDC’s argument here is without pest introduced to the United States in pesticide relying on monitoring data merit because EPA assumed that 100% 1916) was increasingly contaminating and 99.9th percentile. Id. at 16-17 of the blueberries consumed in the shipments of harvested blueberries. (citing an example showing exposure United States would be treated with Although the beetle does not reduce the estimates over an order of magnitude imidacloprid in conducting the production of blueberries in the field, lower when using 99.9th percentile with imidacloprid risk assessment. Although the presence of the beetle mixed in with monitoring data rather than 95th the Federal Register notice explaining harvested blueberries has resulted in percentile assuming tolerance level the basis for the imidacloprid blueberry wholesale rejection by fruit buyers of residues). tolerance does note that ‘‘percent crop shipped blueberries. Purchasers, For imidacloprid, EPA estimated treated data [was] used of selected according to Michigan, follow a ‘‘one acute exposure using the gross commodities,’’ 64 FR 56225, 56228 beetle is too many’’ approach. Michigan overestimate of all crops covered by the (November 7, 2001), those commodities cited one instance in the prior year tolerance containing residues at did not include blueberries. (Ref. 58; see (2000) in which two shipments of tolerance levels. Thus, EPA believes it also Ref. 44 at 43-44) blueberries totaling 1.7 million pounds acted reasonably in using the 95th of blueberries were rejected at the point E. Lack of Emergency percentile of exposure in estimating of delivery. Looking to the future, imidacloprid exposure to the overall In comments filed on its own Michigan noted that ‘‘the three largest population and major identifiable objections, NRDC advances a new buyers of Michigan blueberries for subgroups in making its reasonable challenge to the imidacloprid tolerance yogurt production have chosen not to certainty of no harm finding as to the on blueberries. This challenge is purchase blueberries from Michigan in acute risks posed by imidacloprid. unrelated to the safety issues raised in 2002, because of Japanese beetle 7. Lack of residential exposure its objections; rather, it is instead tied to contamination in previous years.’’ These assessment for adults. NRDC objects to the fact that this imidacloprid tolerance buyers alone purchased 5 million EPA’s decision not to conduct was established in conjunction with pounds of the 65 million pound residential exposure assessments for EPA’s approval of the use of Michigan blueberry crop. Michigan adults despite the fact that imidacloprid imidacloprid under section 18 of FIFRA stated that this contamination had has numerous residential uses. to address an emergency situation in the occurred despite the addition of more Imidacloprid Objections at 16. As state of Michigan. Section 18 of FIFRA workers on packing lines and explained in Unit VII.B.5. above, EPA gives EPA the authority to exempt States investment in expensive color sorting has now determined that residential and Federal agencies from the technologies. No pesticides were then exposure assessments are appropriate as requirements of FIFRA in emergencies. registered for control of Japanese beetle to short-term dermal and inhalation NRDC claims that the ‘‘alleged’’ grubs in blueberries and the two exposures but that other types of emergency justifying the approval of products registered for control of adult residential exposure are unlikely to imidacloprid on blueberries, and Japanese beetles in blueberries are of occur (e.g., short-term adult oral correspondingly the blueberry tolerance, limited effectiveness. exposure and intermediate-term does not meet the criteria for an The basis for NRDC’s challenge to exposure). emergency in EPA regulations. EPA’s conclusion that an emergency 8. Percent crop treated. NRDC asserts Under EPA regulations, EPA may condition existed in Michigan is (1) that that EPA’s use of percent crop treated authorize an emergency exemption if it Michigan did not demonstrate that the data pertaining to blueberries in determines, among other things, that an ‘‘alternative solutions [of using

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additional workers or color sorting U.S.C. 321(q)(2). The IWG argues that, this ‘‘in or on food’’ modifying language. technologies] are economically or because aggregate exposure is described Most notably, the ‘‘in or on food’’ environmentally infeasible;’’ and (2) only in terms of exposure to the qualification is omitted from the that Michigan has failed to provide ‘‘pesticide chemical residue’’ and a aggregate exposure provisions. See 21 economic data on estimated net and pesticide chemical residue is defined as U.S.C. 346a(b)(2)(A)(ii); gross revenues with and without the only including residues in food, 346a(b)(2)(C)(ii)(I); 346a(b)(2)(D)(vi). pesticide. As to whether Michigan aggregate exposure must be limited to Because Congress at times paired the adequately demonstrated the exposure to pesticide residues in food. term ‘‘pesticide chemical residue’’ with infeasibility of addressing the Japanese Under this interpretation, EPA may not the phrase ‘‘in or on food’’ and other beetle problem by using additional consider exposures from non-food times (such as in describing aggregate workers or sorting technology, EPA sources such as residues in drinking exposure) did not, EPA believes that believes that Michigan’s reliance on the water, or residues in or around the Congress’ usage of the term ‘‘pesticide fact that use of these practices has in the home from residential uses of a chemical residue’’ should not be past failed to solve the problem is an pesticide in making the safety interpreted as restricted to residues in or adequate demonstration. Regarding data determination under section 408. on food unless Congress explicitly on potential economic losses, In its initial construction of the FQPA, directed in its specific usage of the term Michigan’s data was not as detailed as and consistently thereafter, EPA has ‘‘pesticide chemical residue’’ that the EPA would have preferred, but in the taken a distinctly different approach to residue must be in or on food. context of an emergency situation, section 408’s safety finding. EPA’s Admittedly, the definition in section providing information indicating that interpretation has been that the statute 201 of ‘‘pesticide chemical residue’’ as close to 10% of the Michigan blueberry requires EPA, in making a section 408 being a residue in or on food creates crop had already been threatened by the safety finding, to consider all exposures ambiguity as to Congress’ precise intent lack of control of Japanese beetles (the to the pesticide and related substances, with regard to its use of the term loss of purchasers for 5 million pounds whether the exposure is from food, ‘‘pesticide chemical residue’’ in section out of Michigan’s 65 million pound water, or other sources, with the 408. As explained below, however, crop) is sufficient to show a ‘‘significant exception that occupational exposures EPA’s interpretation is the only economic loss.’’ are excluded. See, e.g., 61 FR 48843, reasonable interpretation considering In any event, this issue has no 48844 (September 17, 1996) (Aggregate the language, structure, and history of relevance to the action being taken exposure ‘‘includes exposure through section 408. today to establish a permanent tolerance drinking water, but does not include First, other plain language in the for imidacloprid on blueberries because occupational exposure.’’); 62 FR 17096, statute confirms the reasonableness of it is not being done in connection with 17097 (April 9, 1997) (‘‘In examining EPA’s interpretation. On two occasions, an emergency exemption under FIFRA. aggregate exposure, FQPA directs EPA Congress explicitly referenced other to consider available information VIII. Response to Comments on NRDC’s ‘‘sources’’ of exposure as being relevant concerning exposures from pesticide Objections to section 408’s safety standard. First, in residue in food, including water, and all the provision addressing aggregate EPA has responded to the comments other non-occupational exposures. The exposure, Congress directed that EPA submitted that pertained specifically to aggregate sources of exposure the consider aggregate exposure ‘‘to the imidacloprid to the extent the Agency looks at includes food, drinking pesticide chemical residue and to other comments were relevant above. The water or ground water, and exposure related substances, including dietary only remaining comments that EPA from pesticide use in gardens, lawns, or exposure under the tolerance and all believes are appropriate to address are buildings (residential and other indoor other tolerances in effect for the the comments filed by the IWG raising uses).’’); (Ref. 62) (‘‘EPA must now pesticide chemical residue, and legal objections to EPA’s consideration consider other non-occupational sources exposure from other non-occupational of data bearing on exposure to of pesticide exposure when performing sources.’’ 21 U.S.C. 346a(b)(2)(D)(vi) pesticides other than through pesticide risk assessments and setting tolerances. 346a(b)(2)(C) (emphasis added). Second, residues in food. EPA has also included This includes dietary exposure from in expanding the protection for infants a short response to the comments drinking water, non-occupational and children, Congress specified that, received from citizens and IR-4. exposure, exposure from like pesticides for the purposes of making a safety that share a common mechanism of A. IWG Comments finding as to infants and children, ‘‘an toxicity as well as other exposure additional tenfold margin of safety for To recap, the IWG’s argument is based scenarios.’’). (Ref. 48 at 36 and Ref. 49 the pesticide chemical residue and other on the presence of the defined term at 8). Since August 3, 1996, the date of sources of exposures shall be applied . ‘‘pesticide chemical residue’’ in the the passage of the FQPA, EPA has . . .’’ 21 U.S.C. 346a(b)(2)(C)(emphasis critical statutory injunctive that a promulgated hundreds of tolerance added). Thus, Congress could not have pesticide tolerance is safe only if ‘‘there rulemakings and conducted thousands intended that residues in food would be is reasonable certainty that no harm will of tolerance reassessments based on this result from aggregate exposure to the interpretation of the statute. the only ‘‘source’’ considered in pesticide chemical residue, including EPA’s interpretation that it must calculating aggregate exposure. The all dietary exposures and all other consider all non-occupational exposures legislative history is quite clear on this exposures for which there is reliable to pesticides and related substances point, explicitly noting that aggregate information.’’ 21 U.S.C. under section 408 rests on the plain exposure includes both exposure under 346a(b)(2)(A)(ii). The term ‘‘pesticide language of the FQPA, its statutory all tolerances for the pesticide and chemical residue’’ is defined to mean a structure, and its legislative history. exposure from other sources: residue of the pesticide, or any Section 408, by its very terms, in some The Committee understands ‘‘aggregate exposure’’ to the pesticide chemical residue substance present as a result of places dictates that pesticide chemical to include dietary exposures under all metabolism or degradation of the residues being referred to are residues tolerances for the pesticide chemical residue, pesticide, ‘‘in or on raw agricultural ‘‘in or on food’’, see, e.g., 21 U.S.C. and exposure from other non-occupational commodities or processed food.’’ 21 346a(a)(1), and yet, in other places omits sources.

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H. Rept.104-669, Part 2, 40 (July 23, 1996) food’’); 21 U.S.C. 346a(o)(2) (requiring substance. Notably, there is no language Second, the structure of the statute EPA to provide information to retail in the statute suggesting that ‘‘other confirms that considering other grocers concerning actions taken ‘‘that related substances’’ only pertains to ‘‘sources’’ of pesticide exposure in may result in pesticide chemical such substances in or on food. section 408’s safety determination is the residues in or on food . . . .’’), and even EPA cannot accept the argument that, only reasonable interpretation of this anomalies into the statute. For example, because the term ‘‘related substances’’ section. Congress required consideration if each reference in the FFDCA to appears in the pre-FQPA version of of aggregate exposure not just to ‘‘pesticide chemical residue’’ must be to FFDCA section 408 and EPA allegedly pesticide chemical residues but also to a pesticide residue in a food, then under has never stated that ‘‘related ‘‘other related substances.’’ 21 U.S.C. section 402(a)(2)(B), a food is only substances’’ extends to substances 346a(b)(2)(D)(vi). In including ‘‘other rendered adulterated by the presence of residing in exposure sources other than related substances,’’ however, Congress a pesticide if it is a pesticide residue food, Congress’s repetition of the term imposed no limitation that aggregate that is already in a food, since to be ‘‘related substances’’ in the FQPA exposure to these ‘‘other related adulterated a food must ‘‘bear[] or enacted EPA’s supposed sub silentio substances’’ was confined only to contain[] a pesticide chemical residue interpretation of the term ‘‘related aggregate exposure to these substances [in or on a raw agricultural commodity substances’’ as meaning ‘‘related in food. It would be unusual indeed to or processed food] . . . .’’ 21 U.S.C. substances in food.’’ Courts have found suggest that Congress intended that the 342(a)(2)(B) (bracketed language reenactment of administratively- section 408 safety determination on a inserted from the definition of interpreted language to be a ratification pesticide tolerance be constrained in the pesticides chemical residues in 21 of the administrative interpretation but type of pesticide exposures that could U.S.C. 321(q)(2)). Although such an only in circumstances where a be considered (i.e., only pesticide approach might be understandable as longstanding administrative exposures in food but not exposures concerns prepared foods which are a interpretation has been affirmatively from other sources such as drinking mixture of different commodities, it brought to Congress’ attention and water or residential uses) but that no makes no sense as to raw agricultural Congress has clearly expressed its such limitations applied to exposures to commodities which are, and have been, approval. AFL-CIO v. Brock, 835 F.2d substances related to pesticides (i.e., the focus of FDA monitoring efforts 912, 915 (D.C. Cir. 1987); accord, Micron consider exposures to related substances regarding pesticide residues in food Technology, Inc. v. U.S., 243 F.3d 1301, from all sources including food, (Ref. 20 at 3 and Appendices A and B) 1310-1311 (Fed. Cir. 2001). These drinking water, and residential uses). (‘‘Emphasis is on the raw agricultural circumstances are completely absent In contrast to the reasonable product, which is analyzed unwashed here. EPA had not affirmatively coherence between EPA’s approach to and whole (unpeeled).’’). interpreted ‘‘related substances’’ in the interpreting what pesticide residues manner suggested by IWG in an should be considered in making the Finally, the reasonableness of the IWG administrative proceeding prior to section 408 safety determination and the argument is called into question FQPA’s enactment, and Congress never language, structure, and history of the because, even if followed, it seems to explicitly addressed the issue of FQPA, the IWG’s construction is make no difference in what substances interpretation of the term. frequently at odds with these guides to are to be considered in making section For all of these reasons, EPA reaffirms interpretation and, in the end, even if 408 safety determinations. In other its contemporaneous and consistent accepted fails to achieve the IWG’s goal words, IWG’s construction does not interpretation of FFDCA section 408 as of excluding EPA’s consideration of accomplish the IWG objective of requiring consideration of all exposures pesticide residue sources other than limiting the safety determination under to pesticide residues and other related food. section 408 to consideration of pesticide substances other than those exposures The IWG’s narrow approach to residues in food. This is due to the fact occurring in the occupational setting. aggregate exposure cannot explain both that EPA is required to consider both Relevant exposures include pesticide the statute’s and legislative history’s exposures to ‘‘pesticide chemical residues in food and water and references to other ‘‘sources’’ of residues’’ and exposures to ‘‘other exposures to pesticides around the exposure. The IWG’s position is that related substances.’’ If pesticide home or in public from sources other Congress’ reference to ‘‘other non- residues in water, in the air, and on than food and water. occupational sources’’ is a reference to surfaces in and around the home or Alternatively, the IWG argues that the dermal exposure to pesticides from public spaces are not ‘‘pesticide requirement that data on ‘‘all other handling of food containing pesticide chemical residues’’, they certainly exposures’’ be based on ‘‘reliable data’’ residues during food preparation. Yet, would qualify under the plain meaning precludes the consideration of exposure exposure to pesticides from food of the term ‘‘other related substances.’’ information regarding pesticides in handling does not constitute a different For if the IWG position is accepted that drinking water and pesticides used source of pesticide exposure than every substance that would qualify around the home or in public spaces. consumption of food bearing pesticide under the dictionary definition of a EPA has repeatedly rejected this residues. In either case, the source is the pesticide chemical residue does not argument in the past in issuing policy food. Further, strictly following the actually fall within the FFDCA statements regarding implementation of definition of the term ‘‘pesticide definition of pesticide chemical residue, the FQPA. (See Ref. 47 at 135-155). chemical residue’’ introduces numerous it follows necessarily that non-FFDCA- After reviewing the IWG’s latest redundancies, see, e.g., 21 U.S.C. qualifying pesticide chemical residues reiteration of the argument, EPA finds 346a(a) (defining when a ‘‘pesticide have to be some other type of substance. no reason to differ from its earlier chemical residue in or on a food’’ is Further, such other substances are conclusions. unsafe); 21 U.S.C. 321(s) (where the clearly related to FFDCA-defined definition of the term ‘‘food additive’’ pesticide chemical residues given that it B. Citizen Comments states that it excludes ‘‘a pesticide is only the limiting nature of the As mentioned above, EPA received chemical residue in or on a raw statutory definition that keeps them several thousand comments from agricultural commodity or processed from being considered the same private citizens in support of NRDC’s

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objections. These comments, for the sampling and analytical results (June 14. Fenske, R. A., Lu., C, Simcox, N.J., most part, use identical language. NRDC 27, 2002). Loewenherz, C., Touchstone, J., Moate, has urged EPA not to dismiss the citizen 3. Bayer CropScience, Comments to T. F., Allen, E. H., Kissel, J. C., comments because they ‘‘raise a wide the March 19, 2002 NRDC Letter on Strategies for Assessing Children’s range of issues reflecting the different Objections to the Establishment of Organophosphorus Pesticide Exposures ways that people are personally affected Tolerances for Imidacloprid (October in Agricultural Communities, 10(6Pt 2) by EPA’s tolerance decisions.’’ (Ref. 37 16, 2002). Journal of Exposure Analysis and at 4). EPA has considered the citizen 4. Bird, Sandra L., Perry, Steven G., Environmental Epidemiology 662 comments but finds their significance to Ray, Scott L., and Teske, Milton E., (2000a). be limited because they contain only Evaluation of the AgDISP Aerial Spray 15. Fenske, R. A., Kissel, J. C., Lu., C., unsubstantiated claims regarding the Algorithms in the AgDRIFT Model, Kalman, D. A., Simcox, N. J., Allen, E. harms of pesticides or general policy Environmental Toxicology and H., Keifer, M. C., Biologically Based arguments as to why fewer pesticides Chemistry, Vol. 21, No.3, pp. 672-681 Pesticide Dose Estimates for Children in should be used instead of providing (2002). an Agricultural Community, 108 reliable information pertaining to the 5. Bradman, M., Harnly, M., Draper, Environmental Health Perspectives 515 safety standard in section 408(b)(2). W., Seidel, S., Pesticide Exposures to (June 2000b). Children from California’s Central 16. FIFRA Scientific Advisory Panel, C. IR-4 Comments Valley: Results of a Pilot Study, 7 Session III - A Set of Scientific Issues EPA appreciates that, as IR-4 Journal of Exposure Analysis and. Being Considered by the Agency mentioned, imidacloprid is critical for Environmental Epidemiology 217 Regarding Use of Watershed-derived minor crop growers and has an (1997). Percent Crop Areas as a Refinement important role as an organophosphate 6. Burns, Lawrence, Probabilistic Tool in FQPA Drinking Water Exposure replacement. Consideration of Aquatic Exposure Assessment for Assessments for Tolerance information on pesticidal benefits, Pesticides EPA/600/R-01/071 Reassessment (May 27, 1999) (available however, that is often relevant under (September, 2001). at http://www.epa.gov/oscpmont/sap/ FIFRA, see 7 U.S.C. 136(bb), plays a 7. Californians for Pesticide Reform, 1999/may/final.pdf). very limited role under section 408, see Secondhand Pesticides: Airborne 17. FIFRA Scientific Advisory Panel, 21 U.S.C. 346a(b)(2)(B), and is not Pesticide Drift in California (2003). A Set of Scientific Issues Being 8. Camann, D.E., J.S. Colt, S.L. applicable to pesticides such as Considered by the Agency in Connection Teitelbaum, R.A. Rudel, R.M., Hart, M.D imidacloprid which only poses with Proposed Methods for Basin-scale Gammon, Pesticide and PAH threshold-type risks. 21 U.S.C. Estimation of Pesticide Concentrations Distributions in house Dust from Seven 346a(b)(2)(B)(i)(I). in Flowing Water and Reservoirs for Areas of USA, Society of Environmental Tolerance Reassessment, (September 2, IX. Regulatory Assessment Toxicology and Chemistry 21st Annual 1998)(available at http://www.epa.gov/ Requirements Meeting. Nashville , TN (2000). oscpmont/sap/1998/july/final1.pdf). 9. Camann, D. E., Akland, G. G., 18. FIFRA Scientific Advisory Panel, As indicated previously, this action Buckley, J. D., Bond, A. E., Mage, D. T., A Set of Scientific Issues Being announces the Agency’s final order Carpet Dust and Pesticide Exposure of Considered by the Agency in Connection regarding an objection filed under Farm Children, International Society of with Estimating Drinking Water section 408 of FFDCA. As such, this Exposure Analysis Annual Meeting, Exposure as a Component of Dietary action is an adjudication and not a rule. Research Triangle Park, N.C. (November Risk Assessment(1997) (available at The regulatory assessment requirements 5, 1997). http://www.epa.gov/oscpmont/sap/1997 imposed on rulemakings do not, 10. Camann, D.E., Geno, P.W., /december/finaldec.pdf). therefore, apply to this action. Harding, H., Jac, Giardino, N.J. and 19. FIFRA Scientific Advisory Panel, X. Congressional Review Act Bond, A.E., Measurements to assess Transmittal of the Final Report of the exposure of the farmer and family to Joint Science Advisory Board (SAB) and The Congressional Review Act, 5 agricultural pesticides,U.S. EPA the FIFRA Scientific Advisory Panel on U.S.C. 801 et seq., as added by the Small (Contract 68D10150). pp. 712 - 717 the Aquatic Dialogue Group Report: Business Regulatory Enforcement (1993). Pesticide Risk Assessment and Fairness Act of 1996, does not apply 11. Curl, C. L., Fenske, R., Kissel, J. C., Mitigation, (August 7, 1995). because this action is not a rule for Shirai, J. H., Moate, T. F., Griffith, W., 20. Food and Drug Administration, purposes of 5 U.S.C. 804(3). Coronado, G., Thompson, B., Evaluation Residue Monitoring 2001 (2001) XI. Time and Date of Entry of Order of Take-Home Organophosphorus (available at http://www.cfsan.fda.gov/ Pesticide Exposure among Agricultural acrobat/pes01rep.pdf). For the purposes of 28 U.S.C. 2112(a), Workers and Their Children, 110 21. FQPA Implementation Working the date of issuance of this order shall Environmental Health Perspectives A Group, Response to Objections of the be May 26, 2004. 787 (December 2002). Natural Resources Defense Council to XII. References 12. Dourson, M., Felter, S., and Regulations Establishing Tolerances for Robinson, D.,Evolution of Science-based Residues of Various Pesticide Chemicals 1. Acetochlor Registration Uncertainty Factors in Noncancer Risk In or On Food Items (October 16, 2002). Partnership, Surface drinking water Assessment 24 Regulatory Toxicology 22. Gordon, S. M.., Callahan, P. J., monitoring program for acetochlor and and Pharmacology 108 (1996). Nishioka, M. G., Brinkman, M. C., other corn herbicides: Fifth year 13. Fenske 2002: Fenske, R. A., Lu, C., O’Rourke, M. K., Lebowitz, M. D., sampling and analytical results (August Barr, D., Needham, L., Children’s Moschandreas, D. J., Residential 28, 2000). Exposure to Chlorpyrifos and Parathion Environmental Measurements in the 2. Acetochlor Registration in an Agricultural Community in National Human Exposure Assessment Partnership, Surface drinking water Central Washington State, 110 Survey (NHEXAS) Pilot Study in monitoring program for acetochlor and Environmental Health Perspectives 549 Arizona: Preliminary Results for other corn herbicides: Seventh year (May 2002). Pesticides and VOCs, 9 Journal of

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Exposure Analysis and Environmental 34. Mills, P. K., Zahm, S. H., Vegetables; Artichoke; Bushberry; Epidemiology 456 (1999). Organophosphate Pesticide Residues in Lingonberry; Juneberry; Salal; Legume 23. Hertl, P., Phelps, W. et al., A Urine of Farmworkers and Their Vegetables (Except Soybeans); Comparison of US EPA’s Tier 1 and 2 Children in Fresno County, California, Strawberry and Stonefruit. Health Index Reservoir Model Estimates to 40(5) American Journal of Indistrial Effects Division (HED) Risk Assessment. Drinking Water Reservoir Monitoring Medicine 571 (2001). PC Code: 129099. DP Barcodes: Results in Selected Us Systems in 1999/ 35. National Center for Environmental D286101, D284746, D282414, D280766, 2000 (2002). Assessment, U.S. EPA, Exposure Factors D278760, D286722, D280447, and 24. Hewitt, Andrew J., Johnson, David Handbook, Vol. 1 (1997). D285741, (March 4, 2003). R., Fish John D., Hermansky, Clarence 36. Natural Resources Defense 45. Office of Pesticide Programs, US G., and Valcore, David L., Development Council et al., Petition For A Directive EPA, Memorandum from Michael R. of the Spray Drift Task Force Database That the Agency Designate Farm Barrett to Jennifer Tyler, Imidacloprid: for Aerial Applications, 21(3) Children as a Major Identifiable Tier I Drinking Water EEDs for Use in Environmental Toxicology and Subgroup and Population at Special the Human Health Risk Assessment Chemistry, . 648-658 (2002). Risk to Be Protected under the Food (February 25, 2003). 25. Higgins, G. M., Munz, J. F., Quality Protection Act (October 22, 46. Office of Pesticide Programs, US McCauley, L. A.,Monitoring 1998). EPA, Memorandum, Imidacloprid - Acetylcholinesterase Levels in Migrant 37. Natural Resources Defense Report of the Hazard Identification Agricultural Workers and Their Council, Letter from Aaron Colangelo, Assessment Review Committee (TXR # Children Using a Portable Test Kit, 7(1) NRDC, to Office of Pesticide Programs, 0051292) (October 31, 2002). J. Agric. Saf. Hlth. 35 (2001). EPA,OPP-2002-0057 - Additional Data 47. Office of Pesticide Programs, US 26. Holden, Patrick W., Pesticides and on Exposure from Pesticide Drift, and EPA, Office of Pesticide Programs’ groundwater quality: Issues and Summary of Citizen Comments (June 19, Policy on the Determination of the Problems in Four states. National 2003). Appropriate FQPA Safety Factor(s) For Academy Press. (1986). 38. Nishioka, M.G., Burkholder, H.M, Use in the Tolerance Setting Process: 27. Inter-Regional Research Project Brinkman, M.C., and Lewis, R.G., Response to Comments (February 28, Number 4, Response to Natural Distribution of 2,4- 2002) (available at http://www.epa.gov/ Resources Defense Council Objection to Dichlorophenoxyacetic Acid in Floor oppfead1/trac/science/fqpalresp.pdf). Tolerances Established for Certain Dust Throughout Homes Following 48. Office of Pesticide Programs, US Pesticide Chemicals (October 15, 2002). Homeowner and Commercial Lawn EPA, Determination of the Appropriate 28. Jones, R.L. and Russell, M.H., Applications: Quantitative Effect of FQPA Safety Factor(s) in Tolerance FIFRA Environmental Model Validation Children, Pets, and Shoes, 33 Environ. Assessment (January 31, 2002) Task Force: Final Report (April 27, Sci. Technol. 1359-1365 (1999). (available at http://www.epa.gov/ 39. Office of Pesticide Programs, US 2001). oppfead1/trac/science/determ.pdf). EPA, Memorandum, Jeffrey Evans to 49. Office of Pesticide Programs, US 29. Lee, S., McLaughlin, R., Harnly, Betty Shackleford,Spray Drift Estimates EPA, General Principles for Performing M., Gunier, R., Kreutzer, R., Community for Imidacloprid (April 30, 2004). Aggregate Exposure and Risk Exposures to Airborne Agricultural 40. Office of Pesticide Programs, US Assessments (November 28, 2001) Pesticides in California: Ranking of EPA, Memorandum from Jeffrey Evans (available at http://www.epa.gov/ Inhalation Risks, 110 Environmental to Betty Shackleford, Review of Data on pesticides/trac/science/aggregate.pdf). Health Perspectives 1175 (December Farm Children Exposure (April 29, 50. Office of Pesticide Programs, US 2002). 2004). EPA, The Use of Data on Cholinesterase 30. Leonard, R.A., ‘‘Movement of 41. Office of Pesticide Programs, US Inhibition for Risk Assessments of Pesticides in Water,’’ Pesticides in the EPA, Memorandum from Ronald Parker Organophosphorous and Carbamate Soil Environment, SSSA Book Series to Betty Shackleford, Comparison of Pesticides (August 18, 2000)(available at No. 2, Chap. 9, pp. 303-349 (1990). EFED Surface Water Model Estimates http://www.epa.gov/pesticides/trac/ 31. Loewenherz, C., Fenske R. A., with USGS NAWQA Monitoring Values science/cholin.pdf). Simcox N. J., Bellamy G., Kalman D., (April 8, 2004). 51. Office of Pesticide Programs, U.S. Biological Monitoring of 42. Office of Pesticide Programs, US EPA, Available Information on Organophosphorus Pesticide Exposure EPA, Memorandum from Michael R. Assessing Pesticide Exposure From among Children of Agricultural Workers Barrett to Betty Shackleford, Food: A User’s Guide (June 21, 2000) in Central Washington State, 105 Comparison of Ground Water Model (available at http://www.epa.gov/ Environmental Health Perspectives 1344 Estimates and NAWQA Monitoring fedrgstr/EPA-PEST/2000/July/Day-12/ (December 1997). Values (April 30, 2004). 6061.pdf). 32. Lu, C., Knutson, D. E., Fisker- 43. Office of Pesticide Programs, US 52. Office of Pesticide Programs, US Andersen, J, Fenske, R. A.,Biological EPA, Memorandum from Michael R. EPA, Choosing a Percentile of Acute Monitoring Survey of Barrett to Betty Shackleford, Review of Dietary Exposure as a Threshold of Organophosphorus Pesticide Exposure Imidacloprid Ground Water Residue Regulatory Concern (March 16, 2000) among Pre-school Children in the Data from Prospective Ground Water (available at http://www.epa.gov/ Seattle Metropolitan Area, 109 Studies and Long Island Monitoring pesticides/trac/science/trac2b054.pdf). Environmental Health Perspectives 299 Studies (April X, 2004). 53. Office of Pesticide Programs, US (March 2001). 44. Office of Pesticide Programs, US EPA, Drinking Water Screening Level 33. Lu, C., Fenske, R. A., Simcox, N. EPA, Memorandum, from Jennifer R. Assessment Part B(PublicComment J., Kalman, D., Pesticide Exposure of Tyler to Robert Forrest, Imidacloprid in/ Draft 2000) (available at http:// Children in an Agricultural Community: on Cranberry; Okra; Pop corn; www.epa.gov/oppfead1/trac/science/ Evidence of Household Proximity to Watercress; Guava, Papaya, Lychee, reservoir.pdf). Farmland and Take Home Exposure Avocado and Related Commodities; 54. Office of Pesticide Programs, US Pathways, Environmental Research Root and Tuber Vegetables (Except EPA, Estimating the Drinking Water Section A 84, 290 (2000). Sugar Beets); Leaves of Root and Tuber Component of a Dietary Exposure

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Assessment (November 2, 1999) 65. Teske, Milton E., Bird, Sandra L., hearings must be received on or before (available at http://www.epa.gov/ Esterly, David M., Curbishley, Thomas July 26, 2004. fedrgstr/EPA-PEST/1999/November/ B., Ray, Scott L., and Perry, Steven G., ADDRESSES: To submit a written Day-10/6044.pdf). AgDRIFT: A Model for Estimating Near- objection or hearing request follow the 55. Office of Pesticide Programs, U.S. field Spray Drift from Aerial detailed instructions as provided in EPA, Overview of Issues Related to The Applications, 21 Environmental Unit VIII. of the SUPPLEMENTARY Standard Operating Procedures For Toxicology and Chemistry 659-671 INFORMATION. EPA has established a Residential Exposure Assessment, (2002). docket for this action under Docket ID Health Effects Division of the Office of 66. Thompson, B., Coronado, G.D., number OPP–2004–0090. All Pesticide Programs (August 5, Grossman, J.E., Puschel K., Solomon, documents in the docket are listed in 1999)(available at http://www.epa.gov/ C.C., Islas, I, Curl, C.L., Shirai, J.H., the EDOCKET index at http:// oscpmont/sap/1999/september/ Kissel, J.C., and Fenske, R.A., Pesticide www.epa.gov/edocket. Although listed resid.pdf). Take-Home Pathway among Children of in the index, some information is not 56. Office of Pesticide Programs, US Agricultural Workers: Study Design, publicly available, i.e., Confidential EPA, Memorandum, IMIDACLOPRID - Methods, and Baseline Findings, 45 Business Information (CBI) or other Report of the FQPA Safety Factor Journal of Occupational and information whose disclosure is Committee (HED DOC. NO. 013581) Environmental Medicine. 2003, 42-53 restricted by statute. Certain other (July 21, 1999). (2003). material, such as copyrighted material, 57. Office of Pesticide Programs, U.S. 67.US EPA, Pesticide Exposure and is not placed on the Internet and will be EPA, Proposed Methods for Determining Potential Health Effects in Young publicly available only in hard copy Watershed-derived Percent Crop Areas Children Along the U.S.-Mexico Border, form. Publicly available docket and Considerations for Applying Crop 600/R-02/085 (November, 2002). materials are available either Area Adjustments to Surface Water 68. U.S. Geological Survey, National electronically in EDOCKET or in hard Screening Models (May 27, 1999) Water-Quality Assessment Program, copy at the Public Information and (available at http://www.epa.gov/ Report 94-70 (1994). Records Integrity Branch (PIRIB), Rm. oscpmont/sap/1999/may/pcalsap.pdf). 69. Wauchope, R.D. The Pesticide 119, Crystal Mall #2, 1921 Jefferson 58. Office of Pesticide Programs, US content of surface water drainage from Davis Hwy., Arlington, VA. This docket EPA, Memorandum from William agricultural fields: A review, 7 Journal of facility is open from 8:30 a.m. to 4 p.m., Cutchin to Yan Donovan,Dietary Environmental Quality 459-472 (1978). Monday through Friday, excluding legal Exposure Analysis for Imidacloprid in/ List of Subjects holidays. The docket telephone number on Cranberries and Blueberries, is (703) 305–5805. Attachment 1 (April 27, 1999). Environmental protection, FOR FURTHER INFORMATION CONTACT: 59. Office of Pesticide Programs, US Administrative practice and procedure, Agricultural commodities, Pesticides Shaja R. Brothers, Registration Division EPA, Memorandum from Jim Carleton to (7505C), Office of Pesticide Programs, William Wassell, Drinking water and pests, Recordkeeping and requirements. Environmental Protection Agency, 1200 assessment for Imidacloprid (July 15, Pennsylvania Ave., NW., Washington, Dated: May 14, 2004. 1998). DC 20460–0001; telephone number: 60. Office of Pesticide Programs, US James Jones, (703) 308–3194; e-mail address: EPA, Proposed Methods for Basin-scale Director, Office of Pesticide Programs. [email protected]. Estimation of Pesticide Concentrations [FR Doc. 04–11779 Filed 5–25–04; 8:45 am] in Flowing Water and Reservoirs for SUPPLEMENTARY INFORMATION: BILLING CODE 6560–50–S Tolerance Reassessment (1998) (paper I. General Information presented to FIFRA Scientific Advisory A. Does this Action Apply to Me? Panel)(available at http://www.epa.gov/ ENVIRONMENTAL PROTECTION oscpmont/sap/1998/index.htm). AGENCY You may be potentially affected by 61. Office of Pesticide Programs, U.S. this action if you are an agricultural EPA,Standard Operating Procedures for 40 CFR Part 180 producer, food manufacturer, or Residential Exposure Assessment pesticide manufacturer. Potentially [OPP–2004–0090; FRL–7348–1] (1997)(available at http://www.epa.gov/ affected entities may include, but are oscpmont/sap/1997/september/ Imidacloprid; Pesticide Tolerance not limited to: sopindex.htm). • Crop production (NAICS 111), 62. Pesticide Registration Notice 97-1, AGENCY: Environmental Protection e.g., agricultural workers; greenhouse, Agency Actions Under the Requirements Agency (EPA). nursery, and floriculture workers; of the Food Quality Protection Act Sec. ACTION: Final rule. farmers. IV (January 31, 1997) . • Animal production (NAICS 112), 63. Simcox, N.J, Fenske, R.A., Wolz, SUMMARY: This regulation establishes a e.g., cattle ranchers and farmers, dairy S.A., Lee, I.-C. and Kalman, Pesticides tolerance for the combined residues of cattle farmers, livestock farmers. in Household Dust and Soil: Exposure imidacloprid, and its metabolites • Food manufacturing (NAICS 311), Pathways for Children of Agricultural containing the 6-chloropyridinyl e.g., agricultural workers; farmers; Pathways, 103(12) Environ Hlth moiety, all expressed as the parent in or greenhouse, nursery, and floriculture Perspect 1126-34 (1995). on blueberry. Interregional Research workers; ranchers; pesticide applicators. 64. Solomon, K.R., Harris, S.A. and Project Number 4 (IR-4) requested this • Pesticide manufacturing (NAICS Stephenson, G.R., Applicator and tolerance under the Federal Food, Drug, 32532), e.g., agricultural workers; Bystander Exposure to Home Garden and Cosmetic Act (FFDCA), as amended commercial applicators; farmers; and Landscape Pesticides, American by the Food Quality Protection Act of greenhouse, nursery, and floriculture Chemical Society, Pesticides in Urban 1996 (FQPA). workers; residential users. Environments, Chapter 22, pp. 262-274 DATES: This regulation is effective May This listing is not intended to be (Eds. Racke and Leslie) (1993). 26, 2004. Objections and requests for exhaustive, but rather provides a guide

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for readers regarding entities likely to be tolerances for combined residues of the result to infants and children from affected by this action. Other types of insecticide imidacloprid, (1-[(6-chloro- aggregate exposure to the pesticide entities not listed in this unit could also 3-pyridinyl)methyl]-N-nitro-2- chemical residue. . . .’’ be affected. The North American imidazolidinimine), and its metabolites EPA performs a number of analyses to Industrial Classification System containing the 6-chloropyridinyl determine the risks from aggregate (NAICS) codes have been provided to moiety, all expressed as imidacloprid in exposure to pesticide residues. For assist you and others in determining or on blueberry at 3.5 part per million further discussion of the regulatory whether this action might apply to (ppm), in addition to a variety of raw requirements of section 408 of FFDCA certain entities. If you have any agricultural commodities previously and a complete description of the risk questions regarding the applicability of established in the Federal Register of assessment process, see the final rule on this action to a particular entity, consult June 13, 2003 (68 FR 35303) (FRL– Bifenthrin Pesticide Tolerances (62 FR the person listed under FOR FURTHER 7310–8). EPA received objections to a 62961, November 26, 1997) (FRL–5754– INFORMATION CONTACT. time-limited tolerance it established for 7). residues of imidacloprid on blueberries B. How Can I Access this Document and III. Aggregate Risk Assessment and Other Related Information? in connection with an emergency exemption for such use under the Determination of Safety In addition to using EDOCKET(http:/ Federal Insecticide, Fungicide, and Consistent with section 408(b)(2)(D) /www.epa.gov/edocket/), you may Rodenticide Act (FIFRA), 7 U.S.C. 136 of FFDCA, EPA has reviewed the access this Federal Register document et seq. published in the Federal Register available scientific data and other electronically through the EPA Internet of January 18, 2002 (67 FR 2580) (FRL– relevant information in support of this under the ‘‘Federal Register’’ listings at 6817–6). The objections were filed by action. EPA has sufficient data to assess http://www.epa.gov/fedrgstr/. A the Natural Resources Defense Council the hazards of and to make a frequently updated electronic version of (NRDC) and raised several issues 40 CFR part 180 is available at E-CFR determination on aggregate exposure, regarding aggregate exposure estimates consistent with section 408(b)(2) of Beta Site Two at http:// and the additional safety factor for the www.gpoaccess.gov/ecfr/. To access the FFDCA, for a tolerance for combined protection of infants and children. residues of imidacloprid, and its OPPTS Harmonized Guidelines NRDC’s objections raise complex legal, referenced in this document, go directly metabolites containing the 6- scientific, policy, and factual matters. chloropyridinyl moiety, all expressed as to the guidelines at http://www.epa.gov/ Elsewhere in today’s Federal Register opptsfrs/home/guidelin.htm. the parent on blueberry at 3.5 ppm. EPA has denied NRDC’s objections to EPA’s assessment of exposures and risks II. Background and Statutory Findings the now-expired blueberry tolerance as associated with establishing the In the Federal Register of February 5, moot. Because NRDC’s objections are tolerance follows. relevant to this rulemaking establishing 2003 (68 FR 5880) (FRL–7287–5), EPA A. Toxicological Profile issued a notice pursuant to section a new tolerance on blueberries, EPA has 408(d)(3) of FFDCA, 21 U.S.C. treated NRDC’s objections as comments EPA has evaluated the available 346a(d)(3), announcing the filing of on the petition to re-establish the toxicity data and considered its validity, pesticide petitions (PP 1E6268, 1E6254, blueberry tolerance and taken them into completeness, and reliability as well as 1E6237, 1E6225, 0E6203, 2E6403, account in the current action. EPA’s the relationship of the results of the 2E6406, 2E6409, 2E6417, 2E6421, detailed response to NRDC is included studies to human risk. EPA has also 2E6435, 2E6414, 2E6458, and 2E6506) in the document denying its objections. considered available information by IR-4, 681 U.S. Highway #1 South, Individual commodity tolerances for concerning the variability of the North Brunswick, NJ 08902–3390. That other members of the bushberry sensitivities of major identifiable notice included a summary of the subgroup (currant, elderberry, subgroups of consumers, including petitions prepared by Bayer gooseberry and huckleberry) were infants and children. The nature of the CropScience, the registrant. One established in the Federal Register of toxic effects caused by imidacloprid as comment was received in response to June 13, 2003 (68 FR 35303). well as the no observed adverse effect the notice of filing of February 5, 2003, Section 408(b)(2)(A)(i) of FFDCA level (NOAEL) and the lowest observed from an individual who requested that allows EPA to establish a tolerance (the adverse effect level (LOAEL) from the information about pesticide tolerances legal limit for a pesticide chemical toxicity studies reviewed are discussed be available in grocery stores next to the residue in or on a food) only if EPA in Unit III.A. of the Final Rule on food labels. determines that the tolerance is ‘‘safe.’’ Imidacloprid Pesticide Tolerance Pursuant to section 408(o), the Section 408(b)(2)(A)(ii) of FFDCA published in the Federal Register of Consumer Right to Know provision of defines ‘‘safe’’ to mean that ‘‘there is a June 13, 2003 (68 FR 35303). reasonable certainty that no harm will the FFDCA as amended by FQPA, the B. Toxicological Endpoints Agency distributes information on the result from aggregate exposure to the risks and benefits of pesticide chemical pesticide chemical residue, including A summary of the toxicological residues in or on food to large retail all anticipated dietary exposures and all endpoints for imidacloprid used for grocers for public display. Copies of this other exposures for which there is human risk assessment is discussed in EPA brochure entitled, ‘‘Pesticides and reliable information.’’ This includes Unit III.B. of the final rule published in Food: What You and Your Family Need exposure through drinking water and in the Federal Register of June 13, 2003 to Know’’ (Publication No. 735–F–98– residential settings, but does not include (68 FR 35303). These issues are also 00) may be obtained at no cost (http:// occupational exposure. Section discussed in EPA’s response to the www.epa.gov/pesticides/food/) or 408(b)(2)(C) of FFDCA requires EPA to concerns voiced by NRDC in its viewed in its entirety at http:// give special consideration to exposure objections to the prior imidacloprid www.pueblo.gsa.gov/cic_text/food/ of infants and children to the pesticide blueberry tolerance. EPA’s response is pesticides-andfood/food.html. chemical residue in establishing a published elsewhere in today’s Federal The petitions requested that 40 CFR tolerance and to ‘‘ensure that there is a Register. Acute, chronic, and short-term 180.472 be amended by establishing reasonable certainty that no harm will aggregate risk assessments are

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appropriate for imidacloprid and were preservatives for wood products, applying this provision, EPA either performed by EPA. building materials, textiles and plastics. retains the default value of 10X when The non-dietary exposure assessment is reliable data do not support the choice C. Exposure Assessment discussed in the Final Rule on of a different factor, or, if reliable data 1. Dietary exposure from food and Imidacloprid Pesticide Tolerance are available, EPA uses a different feed uses. Tolerances have been published in Unit III.C.3. of the Federal additional safety factor value based on established (40 CFR 180.472) for the Register of June 13, 2003 (68 FR 35303). the use of traditional uncertainty factors combined residues of imidacloprid, in These issues are also discussed in EPA’s and/or special FQPA safety factors, as or on a variety of raw agricultural response to the concerns voiced by appropriate. commodities. Risk assessments were NRDC in its objections to the prior 2. Prenatal and postnatal sensitivity. conducted by EPA to assess dietary imidacloprid blueberry tolerance. EPA’s These issues are discussed in Unit exposures from imidacloprid in a response is published elsewhere in III.D.2. of the Final Rule on variety of raw agricultural commodities. today’s Federal Register. Imidacloprid Pesticide Tolerance Acute and chronic exposure 4. Cumulative effects from substances published in the Federal Register of assessments conducted by EPA to assess with a common mechanism of toxicity. June 13, 2003 (68 FR 35303). These dietary exposures from imidacloprid are Section 408(b)(2)(D)(v) of FFDCA issues are also discussed in EPA’s discussed in Unit III.C.1. of the Final requires that, when considering whether response to the concerns voiced by Rule on Imidacloprid Pesticide to establish, modify, or revoke a NRDC in its objections to the prior Tolerance published in the Federal tolerance, the Agency consider imidacloprid blueberry tolerance. EPA’s Register of June 13, 2003 (68 FR 35303). ‘‘available information’’ concerning the response is published elsewhere in These issues are also discussed in EPA’s cumulative effects of a particular today’s Federal Register. response to the concerns voiced by pesticide’s residues and ‘‘other 3. Conclusion. There is a complete NRDC in its objections to the prior substances that have a common toxicity data base for imidacloprid and imidacloprid blueberry tolerance. EPA’s mechanism of toxicity.’’ exposure data are complete or are response is published elsewhere in Unlike other pesticides for which EPA estimated based on data that reasonably today’s Federal Register. The proposed has followed a cumulative risk approach accounts for potential exposures. EPA tolerance for blueberry at 3.5 ppm was based on a common mechanism of determined that the 10X safety factor to included in the imidacloprid risk toxicity, EPA has not made a common protect infants and children should be assessment of June 13, 2003. mechanism of toxicity finding as to reduced to 3X. For further discussion, 2. Dietary exposure from drinking imidacloprid and any other substances see Unit III.D.3. of the Final Rule on water. FQPA Index Reservoir Screening and imidacloprid does not appear to Imidacloprid Pesticide Tolerance Tool (FIRST) and Screening produce a toxic metabolite produced by published in the Federal Register of Concentration in Groundwater (SCI- other substances. For the purposes of June 13, 2003 (68 FR 35303) (FRL– GROW) model estimated environmental this tolerance action, therefore, EPA has 7310–8). These issues are also discussed concentrations (EECs) for imidacloprid not assumed that imidacloprid has a in EPA’s response to the concerns for acute and chronic exposures are common mechanism of toxicity with voiced by NRDC in its objections to the discussed in Unit III.C.2. of the Final other substances. For information prior imidacloprid blueberry tolerance. Rule on Imidacloprid Pesticide regarding EPA’s efforts to determine EPA’s response is published elsewhere Tolerance published in the Federal which chemicals have a common in today’s Federal Register. Register of June 13, 2003 (68 FR 35303). mechanism of toxicity and to evaluate E. Aggregate Risks and Determination of These issues are also discussed in EPA’s the cumulative effects of such Safety response to the concerns voiced by chemicals, see the policy statements NRDC in its objections to the prior released by EPA’s Office of Pesticide To estimate total aggregate exposure imidacloprid blueberry tolerance. EPA’s Programs concerning common to a pesticide from food, drinking water, response is published elsewhere in mechanism determinations and and residential uses, the Agency today’s Federal Register. procedures for cumulating effects from calculates drinking water levels of 3. From non-dietary exposure. substances found to have a common concerns (DWLOCs) which are used as Imidacloprid is currently registered for mechanism on EPA’s web site at http:/ a point of comparison against EECs. use on the following residential non- /www.epa.gov/pesticides/cumulative/. DWLOC values are not regulatory dietary sites: Granular products for standards for drinking water. DWLOCs application to lawns and ornamental D. Safety Factor for Infants and are theoretical upper limits on a plants; ready-to-use spray for Children pesticide’s concentration in drinking application to flowers, shrubs and house 1.In general. Section 408 of FFDCA water in light of total aggregate exposure plants; plant spikes for application to provides that EPA shall apply an to a pesticide in food and residential indoor and outdoor residential potted additional tenfold margin of safety for uses. In calculating a DWLOC, the plants; ready-to-use potting medium for infants and children in the case of Agency determines how much of the indoor and outdoor plant containers; threshold effects to account for prenatal acceptable exposure (i.e., the PAD) is liquid concentrate for application to and postnatal toxicity and the available for exposure through drinking lawns, trees, shrubs and flowers; and completeness of the data base on water (e.g., allowable chronic water ready-to-use liquid for directed spot toxicity and exposure unless EPA exposure (milligrams/kilogram/day) = application to cats and dogs. In determines based on reliable data that a chronic population adjusted dose - addition, there are numerous registered different margin of safety will be safe for (average food + residential exposure)). products intended for use by infants and children. Margins of safety This allowable exposure through commercial applicators to residential are incorporated into EPA risk drinking water is used to calculate a sites. These include gel baits for assessments either directly through use DWLOC. cockroach control; products intended of a margin of exposure (MOE) analysis A DWLOC will vary depending on the for commercial ornamental, lawn and or through using uncertainty (safety) toxic endpoint, drinking water turf pest control; products for ant factors in calculating a dose level that consumption, and body weights. Default control; and products used as poses no appreciable risk to humans. In body weights and consumption values

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as used by the EPA’s Office of Water are imidacloprid are not likely to pose a by FQPA, EPA will continue to use used to calculate DWLOCs: 2 liter (L)/ cancer risk to humans. those procedures, with appropriate 70 kilogram (kg) (adult male), 2L/60 kg 5. Determination of safety. Based on adjustments, until the necessary (adult female), and 1L/10 kg (child). these risk assessments, EPA concludes modifications can be made. The new Default body weights and drinking that there is a reasonable certainty that section 408(g) of FFDCA provides water consumption values vary on an no harm will result to the general essentially the same process for persons individual basis. This variation will be population, and to infants and children to ‘‘object’’ to a regulation for an taken into account in more refined from aggregate exposure to imidacloprid exemption from the requirement of a screening-level and quantitative residues. EPA’s safety finding is also tolerance issued by EPA under new drinking water exposure assessments. discussed in EPA’s response to the section 408(d) of FFDCA, as was Different populations will have different concerns voiced by NRDC in its provided in the old sections 408 and DWLOCs. Generally, a DWLOC is objections to the prior imidacloprid 409 of FFDCA. However, the period for calculated for each type of risk blueberry tolerance. EPA’s response is filing objections is now 60 days, rather assessment used: Acute, short-term, published elsewhere in today’s Federal than 30 days. intermediate-term, chronic, and cancer. Register. When EECs for surface water and A. What Do I Need to Do to File an IV. Other Considerations ground water are less than the Objection or Request a Hearing? calculated DWLOCs, EPA concludes A. Analytical Enforcement Methodology You must file your objection or with reasonable certainty that exposures Adequate enforcement methods are request a hearing on this regulation in to the pesticide in drinking water (when available for determination of accordance with the instructions considered along with other sources of imidacloprid residues of concern in provided in this unit and in 40 CFR part exposure for which EPA has reliable plant (Bayer Gas Chromatography/Mass 178. To ensure proper receipt by EPA, data) would not result in unacceptable Spectrometry (GC/MS) Method 00200) you must identify docket ID number levels of aggregate human health risk at and livestock commodities (Bayer GC/ OPP–2004–0090 in the subject line on this time. Because EPA considers the MS Method 00191). These methods the first page of your submission. All aggregate risk resulting from multiple have undergone successful EPA petition requests must be in writing, and must be exposure pathways associated with a method validations (PMVs), and the mailed or delivered to the Hearing Clerk pesticide’s uses, levels of comparison in registrant has fulfilled the remaining on or before July 26, 2004. 1. Filing the request. Your objection drinking water may vary as those uses requirements for additional raw data, must specify the specific provisions in change. If new uses are added in the method validation, independent the regulation that you object to, and the future, EPA will reassess the potential laboratory validation (ILV), and an grounds for the objections (40 CFR impacts of residues of the pesticide in acceptable confirmatory method (high 178.25). If a hearing is requested, the drinking water as a part of the aggregate performance liquid chromatography/ objections must include a statement of risk assessment process. ultraviolet (HPLC/UV) Method 00357). the factual issues(s) on which a hearing 1. Acute risk. The acute risk The methods may be requested from: is requested, the requestor’s contentions assessment for imidacloprid is Chief, Analytical Chemistry Branch, on such issues, and a summary of any discussed in Unit III.E.1. of the Final Environmental Science Center, 701 evidence relied upon by the objector 40 Rule on Imidacloprid Pesticide Mapes Rd., Ft. Meade, MD 20755–5350; CFR 178.27. Information submitted in Tolerance published in the Federal telephone number: (410) 305–2905; e- connection with an objection or hearing Register of June 13, 2003 (68 FR 35303). mail address: [email protected]. 2. Chronic risk. The chronic risk request may be claimed confidential by assessment for imidacloprid is B. International Residue Limits marking any part or all of that discussed in Unit III.E.2. of the Final There are no established Codex, information as CBI. Information so Rule on Imidacloprid Pesticide Canadian, or Mexican maximum residue marked will not be disclosed except in Tolerance published in the Federal limits (MRLs) for imidacloprid in/on accordance with procedures set forth in Register of June 13, 2003 (68 FR 35303). blueberries. 40 CFR part 2. A copy of the 3. Short-term risk. Short-term information that does not contain CBI aggregate exposure takes into account V. Conclusion must be submitted for inclusion in the residential exposure plus chronic Therefore, the tolerance is established public record. Information not marked exposure to food and water (considered for combined residues of imidacloprid, confidential may be disclosed publicly to be a background exposure level). (1-[(6-chloro-3-pyridinyl)methyl]-N- by EPA without prior notice. Imidacloprid is currently registered for nitro-2-imidazolidinimine), and its Mail your written request to: Office of use that could result in short-term metabolites containing the 6- the Hearing Clerk (1900C), residential exposure and the Agency has chloropyridinyl moiety, all expressed as Environmental Protection Agency, 1200 determined that it is appropriate to imidacloprid in or on blueberry at 3.5 Pennsylvania Ave., NW., Washington, aggregate chronic food and water and ppm. DC 20460–0001. You may also deliver short-term exposures for imidacloprid. your request to the Office of the Hearing The short-term risk assessment for VI. Objections and Hearing Requests Clerk in Rm. 104, Crystal Mall #2, 1921 Imidacloprid is discussed in Unit III.E.3. Under section 408(g) of FFDCA, as Jefferson Davis Hwy., Arlington, VA. of the Final Rule on Imidacloprid amended by FQPA, any person may file The Office of the Hearing Clerk is open Pesticide Tolerance published in the an objection to any aspect of this from 8 a.m. to 4 p.m., Monday through Federal Register of June 13, 2003 (68 FR regulation and may also request a Friday, excluding legal holidays. The 35303). hearing on those objections. The EPA telephone number for the Office of the 4. Aggregate cancer risk for U.S. procedural regulations which govern the Hearing Clerk is (703) 603–0061. population. There is no evidence of submission of objections and requests 2. Tolerance fee payment. If you file carcinogenicity to humans based on for hearings appear in 40 CFR part 178. an objection or request a hearing, you carcinogenicity studies in male and Although the procedures in those must also pay the fee prescribed by 40 female rats and mice. The Agency regulations require some modification to CFR 180.33(i) or request a waiver of that concludes that pesticidal uses of reflect the amendments made to FFDCA fee pursuant to 40 CFR 180.33(m). You

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must mail the fee to: EPA Headquarters that available evidence identified by the responsibilities among the various Accounting Operations Branch, Office requestor would, if established resolve levels of government, as specified in of Pesticide Programs, P.O. Box one or more of such issues in favor of Executive Order 13132, entitled 360277M, Pittsburgh, PA 15251. Please the requestor, taking into account Federalism (64 FR 43255, August 10, identify the fee submission by labeling uncontested claims or facts to the 1999). Executive Order 13132 requires it ‘‘Tolerance Petition Fees.’’ contrary; and resolution of the factual EPA to develop an accountable process EPA is authorized to waive any fee issues(s) in the manner sought by the to ensure ‘‘meaningful and timely input requirement ‘‘when in the judgement of requestor would be adequate to justify by State and local officials in the the Administrator such a waiver or the action requested (40 CFR 178.32). development of regulatory policies that refund is equitable and not contrary to have federalism implications.’’ ‘‘Policies VII. Statutory and Executive Order the purpose of this subsection.’’ For that have federalism implications’’ is Reviews additional information regarding the defined in the Executive Order to waiver of these fees, you may contact This final rule establishes a tolerance include regulations that have James Tompkins by phone at (703) 305– under section 408(d) of FFDCA in ‘‘substantial direct effects on the States, 5697, by e-mail at response to a petition submitted to the on the relationship between the national [email protected], or by mailing a Agency. The Office of Management and government and the States, or on the request for information to Mr. Tompkins Budget (OMB) has exempted these types distribution of power and at Registration Division (7505C), Office of actions from review under Executive responsibilities among the various of Pesticide Programs, Environmental Order 12866, entitled Regulatory levels of government.’’ This final rule Protection Agency, 1200 Pennsylvania Planning and Review (58 FR 51735, directly regulates growers, food Ave., NW., Washington, DC 20460– October 4, 1993). Because this rule has processors, food handlers and food 0001. been exempted from review under retailers, not States. This action does not If you would like to request a waiver Executive Order 12866 due to its lack of alter the relationships or distribution of of the tolerance objection fees, you must significance, this rule is not subject to power and responsibilities established mail your request for such a waiver to: Executive Order 13211, Actions by Congress in the preemption James Hollins, Information Resources Concerning Regulations That provisions of section 408(n)(4) of and Services Division (7502C), Office of Significantly Affect Energy Supply, FFDCA. For these same reasons, the Pesticide Programs, Environmental Distribution, or Use (66 FR 28355, May Agency has determined that this rule Protection Agency, 1200 Pennsylvania 22, 2001). This final rule does not does not have any ‘‘tribal implications’’ Ave., NW., Washington, DC 20460– contain any information collections as described in Executive Order 13175, 0001. subject to OMB approval under the entitled Consultation and Coordination 3. Copies for the Docket. In addition Paperwork Reduction Act (PRA), 44 with Indian Tribal Governments (65 FR to filing an objection or hearing request U.S.C. 3501 et seq., or impose any 67249, November 6, 2000). Executive with the Hearing Clerk as described in enforceable duty or contain any Order 13175, requires EPA to develop Unit VI.A., you should also send a copy unfunded mandate as described under an accountable process to ensure of your request to the PIRIB for its Title II of the Unfunded Mandates ‘‘meaningful and timely input by tribal inclusion in the official record that is Reform Act of 1995 (UMRA) (Public officials in the development of described in Unit I.B.1. Mail your Law 104–4). Nor does it require any regulatory policies that have tribal copies, identified by docket ID number special considerations under Executive implications.’’ ‘‘Policies that have tribal OPP–2004–0090, to: Public Information Order 12898, entitled Federal Actions to implications’’ is defined in the and Records Integrity Branch, Address Environmental Justice in Executive Order to include regulations Information Resources and Services Minority Populations and Low-Income that have ‘‘substantial direct effects on Division (7502C), Office of Pesticide Populations (59 FR 7629, February 16, one or more Indian tribes, on the Programs, Environmental Protection 1994); or OMB review or any Agency relationship between the Federal Agency, 1200 Pennsylvania Ave., NW., action under Executive Order 13045, Government and the Indian tribes, or on Washington, DC 20460–0001. In person entitled Protection of Children from the distribution of power and or by courier, bring a copy to the Environmental Health Risks and Safety responsibilities between the Federal location of the PIRIB described in Unit Risks (62 FR 19885, April 23, 1997). Government and Indian tribes.’’ This I.B.1. You may also send an electronic This action does not involve any rule will not have substantial direct copy of your request via e-mail to: opp- technical standards that would require effects on tribal governments, on the [email protected]. Please use an ASCII Agency consideration of voluntary relationship between the Federal file format and avoid the use of special consensus standards pursuant to section Government and Indian tribes, or on the characters and any form of encryption. 12(d) of the National Technology distribution of power and Copies of electronic objections and Transfer and Advancement Act of 1995 responsibilities between the Federal hearing requests will also be accepted (NTTAA), Public Law 104–113, section Government and Indian tribes, as on disks in WordPerfect 6.1/8.0 or 12(d) (15 U.S.C. 272 note). Since specified in Executive Order 13175. ASCII file format. Do not include any tolerances and exemptions that are Thus, Executive Order 13175 does not CBI in your electronic copy. You may established on the basis of a petition apply to this rule. also submit an electronic copy of your under section 408(d) of FFDCA, such as VIII. Congressional Review Act request at many Federal Depository the tolerance in this final rule, do not Libraries. require the issuance of a proposed rule, The Congressional Review Act, 5 the requirements of the Regulatory U.S.C. 801 et seq., as added by the Small B. When Will the Agency Grant a Flexibility Act (RFA) (5 U.S.C. 601 et Business Regulatory Enforcement Request for a Hearing? seq.) do not apply. In addition, the Fairness Act of 1996, generally provides A request for a hearing will be granted Agency has determined that this action that before a rule may take effect, the if the Administrator determines that the will not have a substantial direct effect agency promulgating the rule must material submitted shows the following: on States, on the relationship between submit a rule report, which includes a There is a genuine and substantial issue the national government and the States, copy of the rule, to each House of the of fact; there is a reasonable possibility or on the distribution of power and Congress and to the Comptroller General

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of the United States. EPA will submit a I Therefore, 40 CFR chapter I is Parts per Revocation/ report containing this rule and other amended as follows: Commodity million Expiration required information to the U.S. Senate, Date the U.S. House of Representatives, and PART 180— [AMENDED] the Comptroller General of the United ***** I Blueberry States prior to publication of this final 1. The authority citation for part 180 continues to read as follows: ***** rule in the Federal Register. This final 3.5 None rule is not a ‘‘major rule’’ as defined by Authority: 21 U.S.C. 321(q), 346a and 371. 5 U.S.C. 804(2). I 2. Section 180.472 is amended by * * * * * alphabetically adding the following Dated: May 11, 2004. List of Subjects in 40 CFR Part 180 commodity to the table in paragraph (a) Environmental protection, to read as follows: Lois Rossi, Administrative practice and procedure, Director, Registration Division, Office of Agricultural commodities, Pesticides § 180.472 Imidacloprid; tolerances for Pesticide Programs. and pests, Reporting and recordkeeping residues. [FR Doc. 04–11780 Filed 5–25–04; 8:45 am] requirements. (a)*** BILLING CODE 6560–50–S

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Part V

Department of Labor Employee Benefits Security Administration

29 CFR Part 2590 Health Care Continuation Coverage; Final Rule

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DEPARTMENT OF LABOR provisions that became part of the notice and disclosure requirements of Internal Revenue Code (Code) and the COBRA, while the Treasury is Employee Benefits Security Public Health ServiceAct (PHSA). 1 See authorized to issue regulations defining Administration Code section 4980B; PHSA, 42 U.S.C. the required continuation coverage.4 300bb–1 et seq. These provisions are Under its authority to interpret the 29 CFR Part 2590 commonly referred to as the COBRA COBRA provisions, the Treasury has RIN 1210–AA60 provisions, and the continuation issued final regulations that provide coverage that they mandate is rules for determining which plans are Health Care Continuation Coverage commonly referred to as COBRA subject to the COBRA provisions, who coverage. The COBRA provisions of title is or can become a qualified beneficiary, AGENCY: Employee Benefits Security I of ERISA generally require that ‘‘any which events constitute qualifying Administration, Labor. group health plan’’ 2 offer ‘‘qualified events, what COBRA obligations exist in ACTION: Final rules. beneficiaries’’ the opportunity to elect the case of mergers and acquisitions, ‘‘continuation coverage’’ following and the nature of the continuation SUMMARY: This document contains final certain events that would otherwise coverage that must be offered. See Treas. rules implementing the notice result in the loss of coverage Reg. §§ 54.4980B–1 through 54.4980B– requirements of the health care (‘‘qualifying events’’).3 Continuation 10. continuation coverage (COBRA) coverage is a temporary extension of the On May 28, 2003, the Department of provisions of part 6 of title I of the qualified beneficiary’s previous group Labor (the Department) published in the Employee Retirement Income Security health coverage. The right to elect Federal Register (68 FR 31832) Act of 1974 (ERISA or the Act). The continuation coverage allows proposed regulations governing the continuation coverage provisions individuals to maintain group health timing, content, and administration of generally require group health plans to coverage under adverse circumstances the notice obligations arising under provide participants and beneficiaries and to bridge gaps in health coverage sections 601 through 608 of ERISA.5 In who under certain circumstances would that otherwise could limit their access response to the proposed COBRA notice lose coverage (qualified beneficiaries) to health care. regulations, the Department received 26 the opportunity to elect to continue COBRA, as enacted, provides that the public comments from an array of coverage under the plan at group rates Secretary of Labor (the Secretary) has interested parties, including for a limited period of time. the authority under section 608 of organizations representing employers, The final rules set minimum ERISA to carry out the provisions of part group health plans, plan administrators, standards for the timing and content of 6 of title I of ERISA. The Conference persons specializing in COBRA the notices required under the Report that accompanied COBRA administration, and participants and continuation coverage provisions and divided interpretive authority over the beneficiaries. establish standards for administering COBRA provisions between the The Department has made a number the notice process. These rules affect Secretary and the Secretary of the of changes to the regulations and model administrators of group health plans, Treasury (the Treasury) by providing notices in response to the public participants and beneficiaries (including that the Secretary has the authority to comments received on the proposals. qualified beneficiaries) of group health issue regulations implementing the The following provides an overview of plans, and the sponsors and fiduciaries the final rules, public comments, and of such plans. These rules also provide 1 The Code and PHSA COBRA provisions, changes from the proposed regulations. model notices for use by administrators although very similar in other ways, are not These final rules implementing the identical to the COBRA provisions in title I of notice requirements of the COBRA of single-employer group health plans to ERISA in their scope of application. The PHSA satisfy their obligation to provide provisions apply only to State and local provisions of part 6 of title I of ERISA general notices and election notices. governmental plans, and the Code provisions grant also apply for purposes of the COBRA COBRA rights to individuals who would not be DATES: Effective date: These regulations provisions of section 4980B of the considered participants or beneficiaries under Code.6 are effective July 26, 2004. ERISA. See PHSA, 42 U.S.C. 300bb–8; Code section Applicability date: These regulations 5000(b)(1). 4 apply to notice obligations arising under 2 A group health plan is not subject to the COBRA H.R. Conf. Rep. No. 99–453 at 562–63 (1985). provisions for any calendar year if all employers The Conference Report further indicated that the the COBRA provisions of part 6 of title maintaining such plan normally employed fewer Secretary of Health and Human Services, who is to I of ERISA on or after the first day of the than 20 employees on a typical business day during issue regulations implementing the continuation first plan year beginning on or after the the preceding calendar year. See ERISA section coverage requirements for State and local date that is six months after May 26, 601(b). governments, must conform the actual requirements 3 Each of the quoted terms is specifically defined of those regulations to the regulations issued by the 2004. in the COBRA provisions. In particular, the term Secretary and the Treasury. Id. at 563. 5 FOR FURTHER INFORMATION CONTACT: Lisa ‘‘group health plan’’ is defined in section 607(1) of Prior to the development of proposed rules, the the Act to mean an employee welfare benefit plan Department published a Request for Information M. Alexander or Suzanne M. Adelman, as defined in section 3(1) of the Act that provides (RFI) to assess public views on the advisability of Office of Regulations and medical care (as defined in section 213(d) of the developing regulations on the COBRA notice Interpretations, Employee Benefits Code) to participants or beneficiaries directly or provisions. See 62 FR 49894 (Sept. 23, 1997). The Security Administration, (202) 693– through insurance, reimbursement, or otherwise. Department received 15 comments, all of which The Department notes that employee welfare were taken into account in developing the proposed 8500. This is not a toll-free number. benefit plans under ERISA include, inter alia, plans rules. SUPPLEMENTARY INFORMATION: sponsored by unions for their members as well as 6 As noted in footnote 1, above, certain COBRA plans sponsored by employers for their employees. provisions (such as the definitions of group health A. Background Such union-sponsored plans would not involve plan, employee and employer) are not identical in employers in any sponsorship capacity, nor would the Code and title I of ERISA. The Treasury has The continuation coverage provisions, they necessarily cover individuals all of whom are reviewed these rules and concurs that, in those sections 601 through 608 of title I of employees. Although the proposed regulations use cases in which the statutory language is not ERISA, were enacted as part of the the terms ‘‘employer’’ and ‘‘employee,’’ as do the identical, §§ 2590.606–1 through 2590.606–4 would COBRA provisions, in assigning duties, they are nonetheless apply to the COBRA provisions of Consolidated Omnibus Budget intended to apply to all group health plans, as § 4980B of the Code, except to the extent that such Reconciliation Act of 1985 (COBRA), defined in section 607(1) of the Act, subject to regulations are inconsistent with the statutory which also promulgated parallel COBRA. language of the Code.

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B. Overview of Final Regulations applicable to the general notice added to the final regulation providing The final COBRA notice rules, like the requirement of section 606(a)(1) of the that, where an individual is required to proposals, consist of four separate Act. Similar to the proposal, paragraph be furnished an election notice within regulations. Section 2590.606–1 covers (b) establishes a 90-day period for the 90-day period for furnishing general the general notice requirement. In an furnishing the general notice. Generally, notices, the plan administrator may appendix to § 2590.606–1, a model the notice must be furnished to each satisfy its general notice obligation by general notice is provided to facilitate covered employee and to the employee’s furnishing an election notice in compliance with the general notice spouse (if covered under the plan) not accordance with the final regulation requirements. Section 2590.606–2 later than the earlier of: (1) either 90 (§ 2590.606–4(b)). creates rules for employer-provided days from the date on which the Paragraph (c) of the regulation sets notices of the occurrence of a qualifying covered employee or spouse first forth the required minimum content of event. Section 2590.606–3 addresses the becomes covered under the plan or, if a general notice. These content responsibilities of qualified later, the date on which the plan first requirements cover basic information beneficiaries to provide notice of a becomes subject to the continuation regarding COBRA and the rights and qualifying event or a disability. Section coverage requirements; or (2) the date responsibilities of qualified 2590.606–4 deals with the election on which the administrator is required beneficiaries that a participant or notice and other notices that plan to furnish an election notice to the beneficiary would need to know before administrators must provide. In an employee or to his or her spouse or the occurrence of a qualifying event in appendix to § 2590.606–4, a model dependent. order to be able to protect his or her election notice is provided to facilitate While a few commenters expressed COBRA rights. Several commenters argued that the compliance with the election notice concern about the timing of the general proposed regulation and model notice requirements. notice, the majority of commenters The model notices provided in the supported the provision as better should be modified to eliminate or appendices to §§ 2590.606–1 and reflecting current practice and fostering reduce plan-specific information. These 2590.606–4 are intended to be used by efficiency through its possible commenters generally argued that the single-employer plans. Other types of combination with the summary plan use of ‘‘generic’’ (non-plan specific) plans, such as multiemployer plans and description (SPD). The Department general notices could result in cost- plans sponsored by unions for their continues to believe that the timing savings since the same notice could be members, would have to modify the requirements of the regulation protect used without customization by COBRA model notices to reflect the special rules covered employees and their spouses administrators for multiple plans. While or practices that apply in the case of during the first 90 days of coverage by the Department appreciates the such plans.7 The Department further ensuring that they timely receive all the arguments in favor of a ‘‘generic’’ notice, notes that the use of the model notices information they need to understand the Department believes that covered is not required. The model notices their rights. For this reason, the employees and spouses need to know included with these regulations are Department has retained the timing the name of the plan and a plan contact provided solely for the purpose of provisions as proposed. In response to for further continuation coverage and facilitating compliance with the several comments requesting plan information. The Department notes applicable notice requirements. The clarification that the date for the that Technical Release 86–2 (June 26, furnishing of appropriately and furnishing of the general notice under 1986), which provided a model general accurately completed model notices, the regulation is the ‘‘commencement of notice for use shortly after COBRA was however, will be considered by the coverage’’ date for purposes of section enacted, required inclusion of plan- Department to constitute compliance 606(a)(1) of the Act, the Department has specific information for the same with the requirements of the applicable added a new paragraph (§ 2590.606– reasons. The Department, therefore, has notice regulation. 1(b)(2)), providing that a notice retained these requirements in the furnished in accordance with the timing regulation. However, in an effort to Section 2590.606–1 General Notice requirement of the regulation is deemed minimize the difficulty of customizing Section 606(a)(1) of ERISA requires to be provided at the time of the general notice, the Department has group health plans to provide written commencement of coverage under the modified the model general notice to notice of COBRA rights to each covered plan. allow placement of plan-specific employee and spouse (if any) ‘‘at the A number of commenters questioned identification information at the end of time of commencement of coverage’’ the need to furnish a general notice in the notice. The Department also has under the plan. Section 2590.606–1 addition to an election notice when the modified the model general notice to establishes the time frames within election notice must be given to an eliminate identification of both the plan which this general notice must be individual within the initial 90-day administrator and the COBRA provided and describes the specific period of coverage. Having reviewed the administrator. As modified, the model information that the general notice must information required to be contained in general notice requires only the name, contain. the general notice described in address, and phone number of a party The final regulation retains the same § 2590.606–1(c), and the election notice or parties who will provide information general structure of the proposal. As described in § 2590.606–4(b)(4), the about the plan and COBRA upon discussed below, however, some Department believes that, given the request. changes to both the regulation and the comprehensive nature of the A number of commenters argued that accompanying model general notice information in the election notice and the general notice should not be have been made in response to public its importance to a qualified beneficiary, required to address the responsibilities comments. the furnishing of a general notice of qualified beneficiaries to provide Paragraph (b) of the final regulation simultaneously with an election notice notice of second qualifying events, addresses the timing requirements during the initial 90-day period would noting that such information is more be duplicative, if not confusing or appropriate for the SPD and election 7 The model election notice is not designed to be distracting. To address this issue, a new notices. The Department agrees with the used when bankruptcy is the qualifying event. paragraph (§ 2590.606–1(b)(3)) has been commenters that the general notice

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should be as informative as possible however, if a spouse’s coverage under Paragraph (f) provides that delivery of without being unnecessarily complex. the plan begins at a different time from the general notice must be made in For this reason, the Department has the covered employee’s coverage, unless accordance with the standards of 29 modified paragraph (c)(4) to eliminate the spouse’s coverage begins before the CFR 2520.104b-1, including the the proposed requirement that the date on which the notice must be standards for use of electronic media. notice describe how qualified provided to the covered employee, and There were no comments suggesting beneficiaries who are receiving a single notice is then timely sent to changes to this provision. Accordingly, continuation coverage must provide their joint address. In response to one the provision is being adopted without notice of a second qualifying event. In commenter’s request, paragraph (d) has change. A discussion of general issues addition to being included in plan been revised to clarify that there is no relating to the furnishing of notices is SPDs, this information is included as requirement to furnish a general notice contained in section C, entitled part of the election notice required to dependent children, even if the ‘‘Miscellaneous.’’ under § 2590.606–4 and, therefore, will general notice requirement is triggered The model general notice appended to be furnished when it will be more early by the occurrence of a qualifying § 2590.606–1 has been revised to reflect relevant to the qualified beneficiary. event involving such an individual. the changes discussed above. The Commenters also argued that, because As indicated in the preamble to the Department also has made a number of different qualifying events under a proposal, in-hand furnishing of the editorial changes in response to single plan may produce different general notice at the workplace to a suggestions and recommendations to COBRA coverage start dates (since the covered employee is deemed to be improve the clarity of the model general plan may choose to begin COBRA adequate delivery to the employee, notice. coverage on either the date of the although such delivery to the employee qualifying event or the date of loss of would not constitute delivery to the Section 2590.606–2 Employer’s Notice coverage), requiring that specific spouse. Except for minor editorial of Qualifying Event information to be described in the changes intended to make the provision Section 606(a)(2) of ERISA requires an general notice makes the notice more clear, this paragraph is being employer to provide notice to the plan unnecessarily complicated, particularly retained as proposed. administrator of a qualifying event that since this information will be available Paragraph (e) of the final regulation is either the employee’s termination of in SPDs. The commenters assumed the permits plans to satisfy the general employment or reduction in hours of regulation required such detail because notice requirement by including the employment, the employee’s death, the the proposed model general notice information described in paragraphs employee’s becoming entitled to provided for inclusion of this (c)(1), (2), (3), (4), and (5) in the SPD of Medicare, or the commencement of a information. The Department agrees the plan and providing the SPD at a proceeding in bankruptcy with respect with the commenters that such time that complies with the timing to the employer. Regulation § 2590.606– information should not be required as requirements for the general notice. 2 addresses this notice obligation of part of the general notice if it will make Some commenters argued that, given the the notice unnecessarily complicated. importance of the information it employers. While no changes are required to the contains, the general notice should be Paragraph (b) of the regulation regulation, to avoid any confusion, the required to be furnished as a stand- provides that an employer shall notify Department has modified the model alone notice, as well as being included the plan administrator of a qualifying general notice to eliminate references to in the SPD. The Department continues event no later than 30 days after the date COBRA coverage beginning dates. The to believe that many, and perhaps most, of the qualifying event. However, Department notes, however, that plans would prefer to take advantage of paragraph (b) further provides that, for nothing in the regulation or the model the reduced cost and added efficiency of any plan under which continuation general notice precludes a plan providing a single disclosure document coverage begins, pursuant to section administrator from including such that satisfies both the general notice 607(5) of the Act, with the date of loss information in a plan’s general notice. requirement and the SPD requirement. of coverage, the 30-day period for A few commenters expressed concern Moreover, the Department believes that providing the notice of qualifying event that the proposal required the general participants and beneficiaries are more must also begin with the date of loss of notice to include a statement that more likely to retain and have ready access to coverage, rather than the date of the complete information about their SPD than a general notice qualifying event. Paragraphs (b) and (d) continuation coverage and other rights furnished separate and apart from their also recognize that multiemployer plans under the plan is available from the SPD. The Department, therefore, has may have different notice periods, as plan administrator and the plan’s SPD. retained this provision without change. permitted under sections 606(a)(2) and Because covered employees and spouses The Department emphasizes, however, 606(b). may need additional information about that retention of this provision is not Paragraph (c) of the regulation their rights under their plan, the intended in any way to limit a plan’s requires that an employer provide the Department believes that they should be flexibility to provide other information plan administrator sufficient reminded that there are sources for that in other forms to its employees and the information to enable the administrator information, namely the plan spouses of its employees. to determine the identity of the plan, the administrator and the plan’s SPD. As noted in the proposal, if a plan covered employee, the qualifying event, Therefore, this provision is retained in chooses to satisfy its SPD and general and the date of the qualifying event. the final regulation. notice obligations by furnishing a single The comments received by the Paragraph (d) permits delivery of a document, the plan must ensure that the Department on this regulation single notice addressed to a covered document satisfies both the general supported the approach taken in the employee and the covered employee’s notice content requirements and the proposal. The Department, therefore, is spouse at their joint residence, provided SPD content requirements.8 the plan’s latest information indicates description of COBRA rights, that must be included that both reside at that address. A single 8 The SPD content regulation, § 2520.102–3, in an SPD for a group health plan. See, e.g., notice would not be permitted, specifies other information, in addition to § 2520.102–3(j), (l), (s).

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adopting this section without adopt reasonable procedures, notice provision in the final regulation without modification. would be deemed provided if change. communicated either to the person or Paragraph (c) provides the time limits Section 2590.606–3 Qualified organizational unit that has customarily that may apply to qualified Beneficiaries’ Notices handled employee benefit matters of the beneficiaries’ notices. These limits are Under section 606(a)(3) of the Act, employer or to any officer of the minimums that may be imposed by a each covered employee or qualified employer. plan. There is nothing in the regulation beneficiary is responsible for notifying While some commenters expressed that prevents plans from providing the plan administrator of a qualifying concern that requiring plans to adopt longer periods for furnishing these event that is either the divorce or legal qualified beneficiary notice procedures notices. In general, a plan must allow an separation of the employee from his or may force them into creating formal, employee or qualified beneficiary at her spouse or a child’s becoming no inflexible procedures that will harm least 60 days to provide notice of a longer eligible to be covered as a participants, most commenters qualifying event that is divorce, legal dependent under the plan. Regulation recognized and supported the separation, a child’s ceasing to be a § 2590.606–3 provides guidance with importance of establishing notice dependent under the plan, or a second respect to this notice obligation and processes that are clearly communicated qualifying event. As proposed, the other notice obligations of qualified to the plan’s participants and starting date for the minimum 60-day beneficiaries, such as the notice of beneficiaries. With regard to plans that period was based, in part, on what the disability or second qualifying event. fail to adopt reasonable procedures, plan provided for the start of COBRA Except as noted below, the final some commenters suggested that notice coverage pursuant to section 607(5) of regulation follows the framework of the should also be deemed to have been the Act. At the suggestion of a proposal. provided if given to the managers and commenter and for purposes of Paragraph (a) describes the notices supervisors of the employee. Other simplicity, the Department has that covered employees and qualified commenters argued that recognizing restructured paragraph (c)(1) of beneficiaries may be required to provide oral notifications and notifications given § 2590.606–3 to conform with Treasury to the administrator, which include to the officers of an employer would regulations by providing that the 60-day notices of the occurrence of a qualifying cause confusion and uncertainty as to period begins to run from the latest of: event that is a divorce, legal separation, when and if notice was provided. In (1) The date of the qualifying event; (2) or a child’s ceasing to be a dependent response to these comments, the the date on which there is a loss of under the plan; the occurrence of a Department has decided to retain the coverage; or (3) the date on which the second qualifying event; a default standards recognizing oral qualified beneficiary is informed, determination of disability by the Social notifications, where a plan fails to adopt through the plan’s SPD or the general Security Administration; and a reasonable notification procedures. To COBRA notice, of his or her obligation determination by the Social Security restrict the default notice standards to to provide notice and the procedures for Administration that a qualified recognize only written communications providing such notice. See Treas. Reg. beneficiary is no longer disabled. would allow plans that fail to adopt § 54.4980B–6, Q&A–2. Paragraph (b) of the final regulation, express notice procedures to rely on a One commenter questioned why the like the proposal, requires plans to de facto standard requiring written regulation requires the furnishing of an establish reasonable procedures for the notice, which in the Department’s view SPD or general COBRA notice before the furnishing of these notices and sets would be unfair to participants and 60-day period for notices of qualifying general standards for what will be beneficiaries. However, the Department event may begin to run against a 9 considered reasonable. Under this recognizes that the breadth of the qualified beneficiary. Inasmuch as a provision, a plan’s procedures generally approach of the proposed regulation in qualified beneficiary might be denied will be considered reasonable if they are this regard may have the potential for continuation coverage because he or she described in the plan’s SPD, specify uncertainty and confusion. Since it is failed to furnish timely notice of a who is designated to receive notices, reasonable to expect an employee or qualifying event, the Department and specify the means qualified qualified beneficiary, even in the believes that disclosing the notice beneficiaries must use for giving notice absence of reasonable plan procedures, obligations and the procedures for and the required content of the notice. to give notice of an event to a party that providing such notice is critical to the Paragraph (b) further provides that, if a customarily handles employee benefit exercise of statutory rights. The plan does not have reasonable matters, the Department has eliminated framework of the final regulation, like procedures for qualified beneficiaries’ the reference, at § 2590.606–3(b)(4)(i), to the proposal, is intended to ensure that notices, notice will be deemed to have ‘‘any officer of the employer.’’ qualified beneficiaries will not be been provided when a written or oral Like the proposal, paragraph (b)(3) of adversely affected in efforts to exercise § 2590.606–3 provides that plans may communication identifying a specific their COBRA rights by a plan’s failure require qualified beneficiaries to event is communicated in a manner to provide adequate disclosure. reasonably calculated to bring the provide specific information via a Several commenters raised questions information to parties that would specific form, if the form is easily concerning the time limits, at customarily be considered to be available to qualified beneficiaries § 2590.606–3 (c)(2) of the proposed rule, responsible for the plan. The proposed without cost. One commenter objected for notices of disability regulation specified that, in the case of to allowing plans to require use of a determinations.10 Specifically, the a single-employer plan that failed to specific form for notice of qualifying event. The Department believes that 10 The COBRA provisions require group health 9 ERISA does not mandate that qualified employees and qualified beneficiaries plans to provide certain qualified beneficiaries an beneficiaries provide notices of qualifying event or may, in fact, benefit from a plan’s use 11-month disability extension of an 18-month disability. A qualified beneficiary may not wish to of specific forms, which would remove period of COBRA coverage (resulting in a total of elect or extend continuation coverage and may 29 months of COBRA coverage), provided the therefore decide to forgo providing the notice of uncertainty about how to comply with qualified beneficiary (or any other qualified qualifying event without violating the COBRA the plan’s requirements. The beneficiary who is a member of his or her family) provisions. Department, therefore, has retained this Continued

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commenters suggested that the proposal beneficiaries to provide a disability qualified beneficiary fails to provide the was ambiguous with respect to notice within 60 days after the latest of: requested information within some individuals who receive a disability (1) The date of the SSA disability reasonable period of time. The determination from the Social Security determination; (2) the date on which the Department believes that both the plan Administration (SSA) at some time prior qualifying event occurs; (3) the date on and the plan’s participants and to the occurrence of a qualifying event. which the qualified beneficiary loses beneficiaries would benefit from a Since the proposed regulation would coverage; or (4) the date on which the procedure that specifically defines permit plans to require qualified qualified beneficiary is informed of the when and under what circumstances, beneficiaries to provide a disability obligation to provide the disability following a request for more complete notice within 60 days of the later of (1) notice. The final regulation reflects this information, a notice will be rejected the date of the SSA disability interpretation in § 2590.606–3(c)(2). due to a failure to provide the determination, or (2) the date on which Under this interpretation, an individual information a plan requires.13 the qualified beneficiary is notified of who previously received an SSA In view of the comments, paragraph the obligation to provide the disability disability determination and has not (d) of the proposal is adopted without notice, the commenters requested that received a subsequent SSA modification. Inasmuch as no comments the Department clarify whether and how determination that he or she is no longer were submitted on paragraphs (e) these rules would apply to individuals disabled would have at least 60 days through (g) of the proposal, those who received an SSA disability after the occurrence of a qualifying paragraphs are also adopted as determination before receiving notice of event to provide the plan with a proposed. the obligation to provide the disability disability notice in order to be entitled Section 2590.606–4 Plan notice. The commenters noted that the to the disability extension.12 There is Administrator’s Notice Obligations Treasury regulations create a rule for nothing that precludes plans from individuals who have been determined allowing a longer period for providing Section 606(a)(4) of ERISA requires a by SSA to be disabled prior to the this notice. For example, a plan may plan administrator to notify each occurrence of a qualifying event under find it administratively more convenient qualified beneficiary who is entitled to which their disability is considered to to permit individuals who receive an elect continuation coverage of his or her continue to exist as of the qualifying SSA determination prior to a qualifying COBRA rights. Section 606(c) requires a event, provided SSA has not issued a event to provide the notice of disability plan administrator to provide such subsequent determination that they are within the same time period within notice within 14 days after the plan no longer disabled. Under the Treasury which the election notice is required to administrator is notified of a qualifying regulations, therefore, qualified be provided. event. Regulation § 2590.606–4 provides beneficiaries who have a prior SSA Paragraph (d) of § 2590.606–3, like the guidance on the requirements of disability determination are considered proposal, provides that a plan may not sections 606(a)(4) and 606(c). In general, to meet the statutory requirement of reject an incomplete notice as untimely the regulation describes timing and being disabled ‘‘within the first 60 if the notice is provided within the content requirements for election days’’ of COBRA coverage. See Treas. plan’s time limits and contains enough notices, requires administrators to notify Reg. § 54.4980B–7, Q&A–5(c). information to enable the plan individuals under certain circumstances The Department agrees with the administrator to identify the plan, the if continuation coverage is determined commenters that there is a need for covered employee and qualified not to be available, and requires plan further clarification in this area. beneficiar(ies), the qualifying event or administrators to provide notice when Following a review of section 606(a)(3) disability determination, and the date continuation coverage terminates before of the Act, the legislative changes to the on which such event or determination the end of the maximum period for such COBRA provisions since 1986, and the occurred. However, if a timely notice coverage. Treasury regulations, the Department fails to supply all of the information Paragraph (a) of the final regulation has concluded that, for purposes of required under the plan’s procedures, describes the obligation of the section 606(a)(3) of the Act, an SSA the plan administrator can require administrator of a group health plan to disability determination, once issued, qualified beneficiaries to supply the provide qualified beneficiaries with should be considered to remain in missing information. Several notice of their right to elect continuation continuing effect until the SSA makes a commenters asked for a clarification as coverage under the plan. 11 contrary determination. For this to whether a plan could reject a Paragraph (b) of the final regulation reason, the Department believes that deficient notice if, following a request to addresses the specific timing and section 606(a)(3) is best interpreted to provide the information required by the content requirements for the election permit plans to require qualified plan’s procedures, a covered employee notice.14 With regard to timing, or qualified beneficiary fails to provide is both determined by SSA to be disabled during the requested information. It is the view 13 The plan’s procedures must be reasonable in all the first 60 days of COBRA coverage and also respects, including the rules for what information provides notice to the plan of SSA’s disability of the Department that there is nothing is required, how much time an individual is given determination within 60 days after the date of the in the final regulation that would to provide the required information, and the bases determination. The notice must be provided before preclude a plan, following a request for for accepting or rejecting a notice. the end of the first 18 months of continuation more complete information, from 14 The regulation requires an administrator to coverage. See ERISA sections 602(2)(A); 606(a)(3). provide an election notice only when it has been 11 Congress recognized the continuing effect of an rejecting a notice when an employee or determined that a qualified beneficiary is entitled SSA disability determination by including in the to elect continuation coverage. In this regard, the COBRA provisions both a provision requiring a 12 The general notice requirement would also Department notes that it is the administrator’s qualified beneficiary who provides a disability have to have been fulfilled with respect to that responsibility to determine whether individuals notice to provide the plan with a subsequent notice individual. Since the general notice is required to who are named in a notice of qualifying event are if the SSA determines him or her to be no longer be furnished only to the covered employee and entitled to continuation coverage and that disputes disabled and a provision permitting plans to spouse (if also covered), the Department will may arise over the correctness of the administrator’s terminate the 11-month disability extension one consider furnishing the general notice to either of determinations. The Department further notes that month after the SSA makes a determination that the those two individuals adequate notice with respect determinations regarding eligibility for COBRA qualified beneficiary is no longer disabled. See to a disabled child of the covered employee for this continuation coverage, like determinations ERISA sections 602(2)(E); 606(a)(3). purpose. involving eligibility for coverage under a group

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paragraph (b)(1) of the final regulation understand that election or non-election As proposed, the model election generally provides that the of COBRA continuation coverage may notice included an optional paragraph administrator shall furnish an election have significant implications for their describing the 65% health coverage tax notice to qualified beneficiaries within future exercise of HIPAA rights and credit (HCTC) created by the Trade Act 14 days after the receipt of notice of a their ability to obtain health care of 2002 (the Trade Act) that may be used qualifying event. coverage. The Department is concerned if an administrator believes employees Paragraph (b)(2) provides a special that the significance of the HIPAA might be eligible for trade adjustment timing rule in connection with information may be lost if the election assistance (TAA) and therefore eligible qualifying events for which the notice merely refers to the SPD for more for the HCTC.16 Some commenters employer must notify the plan, where information about plan rights. Similarly, suggested that Trade Act model the employer is also the administrator of the Department believes that qualified language be expanded to refer not only the plan. Under the special rule, an beneficiaries should have ready access to individuals potentially eligible for the election notice must be furnished not to additional information about COBRA HCTC because of eligibility for TAA later than 44 days after the date of the and their rights under the plan. Because (TAA-eligibles) but also to individuals qualifying event, or, if the plan provides all qualified beneficiaries may not have potentially eligible for the HCTC that COBRA coverage starts on the date the plan’s SPD, requiring that specific because they may be receiving payments of loss of coverage, the date the contact information be included in the from the Pension Benefit Guaranty qualified beneficiary loses coverage election notice is the best way to ensure Corporation (PBGC-eligibles). Other under the plan. The Department has that all qualified beneficiaries have commenters requested that the Trade revised the final regulation, as suggested access to the available information. Act paragraph be expanded to include by one commenter, to make clear that The Department is persuaded, additional information on how the new the 44-day rule applies only in those however, that qualified beneficiaries second COBRA election period created cases where the employer is required to would not be adversely affected by by the Trade Act relates to preexisting provide notice of a qualifying event to elimination of the requirement that condition exclusion periods under the plan administrator. Paragraph (b)(2) information concerning alternative HIPAA and how to become certified for has also been revised to reflect the coverage and conversion rights be TAA. Other commenters requested that possibility that a plan may adopt a included in the election notice. the Department make clear that the different starting date for COBRA Accordingly, the final regulation does election notice is not required to contain coverage for different types of qualifying not include those items in the list of any Trade Act information. As with the proposed regulation, the events. required content for the election notice. final regulation does not impose any Paragraph (b)(3) of the final regulation In making these changes, the specific disclosure requirement contains a special timing rule for Department notes that information on regarding rights and duties that may multiemployer plans. No comments these subjects is likely to be provided by arise as a result of the Trade Act. were received on this provision. the plan in some other form, either in Nonetheless, the Department has Accordingly, paragraph (b)(3) is adopted connection with offering the individual included an optional Trade Act without modification. a choice between COBRA coverage and Paragraph (b)(4) of the final regulation paragraph in the model election notice the plan’s alternative coverage options, sets forth the content requirements for to assist administrators who wish to or at the time that COBRA continuation the election notice. The Department notify potentially eligible individuals of coverage ends.15 received several comments on this their rights under the Trade Act as they section and the corresponding model Some commenters requested that the relate to continuation coverage. In this election notice. regulation and model election notice be regard, the Department has modified the Several commenters argued that the modified to clarify that the election model election notice Trade Act regulation required too much notice need not identify by name each language to reference both PBGC- information to be included in the qualified beneficiary entitled to elect eligibles and TAA-eligibles. With regard election notice. In this regard, continuation coverage. In response to to including more detailed information commenters suggested elimination of this comment, paragraph (b)(4)(iii) has about Trade Act, the Department HIPAA information, information about been revised to make clear that believes that the governmental sources alternative coverage and conversion identification of qualified beneficiaries identified in the model election notice rights, and plan contact information may be accomplished either by represent the best sources for detailed because much of that information is reference to their status (e.g., employee, information on Trade Act-related rights available in the SPD. Conversely, other spouse, dependent child covered under and procedures. commenters argued that the election the plan prior to the qualifying event) or In addition to the aforementioned notice did not include enough by name. The Department intends that comments, the Department received a information and suggested that the identification by status must be number of comments suggesting content requirements be expanded in sufficiently detailed to permit the modifications to the model election various ways. affected individuals to determine notice to improve its clarity and Following a careful review of these whether they are qualified beneficiaries. readability. In finalizing the model comments, the Department has decided The model election notice has been election notice, the Department has to retain the requirements that HIPAA revised accordingly. taken into account all of these information and plan contact information be included in the election 15 The COBRA provisions separately require 16 As noted in the preamble to the proposed notice. The Department believes it is plans to provide qualified beneficiaries who receive regulation, it is the view of the Department that the maximum amount of COBRA coverage available information on the possible availability of a new important that qualified beneficiaries to them the option of enrollment under a second COBRA election period in the event of TAA conversion health plan if such right is otherwise eligibility should, pursuant to § 2520.102–3(o), be health plan, are not governed by ERISA’s claims generally available under the plan. The option must included in the summary plan description of a procedure regulation unless they relate to a specific be provided during the 180-day period ending on group health plan as part of the discussion of the claim for benefits. See preamble to § 2560.503–1, 65 the expiration date of the period of COBRA continuation coverage provisions of the plan. See FR 70246, 70255 (Nov. 21, 2000). coverage. See ERISA section 602(5). 68 FR 31831, 31833 (May 28, 2003).

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suggestions and has made a variety of be provided, with some modification. It provided under HIPAA. Another revisions intended to improve, clarify, is the view of the Department that when commenter objected to the proposal’s and simplify the model notice. a participant or beneficiary submits a adoption of the requirement that the The Department received a number of request to the plan administrator for early termination notice be furnished comments on the notice requirements COBRA continuation coverage, the ‘‘as soon as practicable,’’ suggesting that set forth in paragraphs (c) and (d) of individual has an expectation of a specific time frame would be more proposed § 2590.606–4. Under coverage unless (or until) he or she is workable. One commenter suggested paragraph (c) of the proposed notified to the contrary. The Department that the early termination notice be § 2590.606–4, if a plan administrator continues to believe that furnishing the required only when coverage terminates receives a notice of a qualifying event unavailability notice in such ‘‘voluntarily’’ or for lack of premium pursuant to § 2590.606–3 from an circumstances will avoid payment. individual not eligible to receive misunderstandings in this area. The Following consideration of the continuation coverage under the plan, Department also believes that the comments on paragraph (d), the the administrator would be required to proposed time frame of 14 days, Department has decided to retain the provide notice to the individual(s) paralleling the time frame for providing early termination notice requirements as explaining why he or she is not entitled an election notice after receiving a proposed. As noted in the proposal, to such coverage. This unavailability notice of qualifying event, is appropriate continuation coverage may be notice was to be provided within the for the unavailability notice. Therefore, terminated earlier than the end of the same time frame for providing an the final regulation retains the time maximum period for many different election notice, i.e., within 14 days after frame of the proposal. reasons. The Department continues to receipt of the notice of a qualifying Commenters questioned whether the believe that providing a notice of early event. Under paragraph (d) of the unavailability notice is required only termination serves an important proposal, the administrator would be after receipt of ‘‘a notice of a qualifying administrative function and permits required to provide notice to qualified event furnished in accordance with qualified beneficiaries to take beneficiaries in the event that § 2590.606–3,’’ as stated in the proposal, appropriate next steps to protect their continuation coverage terminates before or whether the unavailability notice access to health coverage, either on a the end of its maximum duration. This must also be provided after receipt of group or individual basis. early termination notice was to be any qualified beneficiary’s notice In retaining the notice of early provided as soon as practicable furnished in accordance with termination of continuation coverage following the administrator’s § 2590.606–3. There appears to be little requirement, the Department is not determination that continuation basis for distinguishing among the requiring that the notice be furnished coverage shall terminate. various qualified beneficiary notices before COBRA coverage can be A number of commenters argued that that may be required to be furnished in terminated or within a specified time the notice provisions of paragraphs (c) accordance with § 2590.606–3 on the frame. To require notification to be and (d) should be eliminated entirely. basis of the expectations of the These commenters generally argued that individual furnishing the notice. made in advance of an otherwise these notices are not required by statute, Accordingly, the Department has permissible early termination of that the notices create serious modified the language of paragraph continuation coverage would extend administrative concerns, that they (c)(1) to clarify that the unavailability COBRA continuation coverage beyond duplicate information already required notice must be furnished when the plan the statutory periods, which would be to be disclosed in plan SPDs or election administrator denies coverage after beyond the Department’s interpretive notices, and that they increase the risk receiving a notice described in and regulatory authority. In recognition of civil penalties and litigation for plan § 2590.606–3, regardless of the basis of of the fact that there may be instances sponsors. At the same time, commenters the denial and regardless of whether the when an administrator is able to furnish indicated that many plans already notice involves a first qualifying event, an early termination notice in advance provide similar notifications. A number a second qualifying event, or a request of the early termination of COBRA of commenters supported these notice for a disability extension. For example, coverage, the Department has retained requirements, but suggested changes or the unavailability notice would be the requirement that notice of an early clarifications. required to be provided when a plan termination be furnished as soon as With regard to the unavailability administrator denies continuation reasonably practicable. The Department notice of paragraph (c), some coverage because it has been determined believes that this standard is in the best commenters suggested that that no qualifying event had occurred or interest of the qualified beneficiaries. administrators should be required to because the qualified beneficiary did The Department further believes that provide the notice ‘‘as soon as not furnish the notice of qualifying allowing plans to combine furnishing possible,’’ although not later than 14 event notice in a timely manner or did the early termination notice with the days after receiving the notice of not provide complete information. certificate of creditable coverage qualifying event. Another commenter With respect to the early termination required under HIPAA would benefit argued that the time frame for notice of paragraph (d) of the proposal, the qualified beneficiary by providing furnishing the unavailability notice in addition to those commenters related benefit information in a single should conform to the time frame for opposing the notice obligation in its information package and would benefit furnishing notice of a benefit claim entirety, some commenters suggested the plan as a result of reduced denial. Other commenters requested changes. One commenter suggested that administrative costs. For this reason, the clarification concerning the plan administrators be required to Department reiterates the view circumstances that would trigger the provide an early termination notice in expressed in the proposal that nothing notice requirement. advance of terminating COBRA coverage in these regulations is intended to After consideration of the comments, and that plan administrators should not prevent a plan administrator from the Department has decided to retain be allowed to combine the early combining the furnishing of an early the requirement that notice of termination notice with the notice of termination notice with the furnishing unavailability of continuation coverage creditable coverage required to be of the certificate of creditable coverage.

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One commenter recommended that received by the individual to whom the first plan year beginning on or after the the Department develop model notices notice is directed.18 In the absence of date that is six months after the date of for the unavailability notice and the written plan procedures to the contrary publication of the final rules in the early termination notice required under that are communicated to participants Federal Register.19 The regulations are paragraphs (c) and (d) of § 2590.606–4. and beneficiaries, it is the view of the scheduled to become effective sixty The Department has not adopted this Department that the same standards days after the date of publication in the suggestion due to the event-specific would apply to notices of qualifying Federal Register. nature of the required notices. In the event furnished by an employer to the The preamble to the proposed Department’s view, it would be difficult plan administrator and to COBRA regulations made clear that plans could to develop a single model form for such notices provided by covered employees, no longer rely upon prior guidance notices that would serve adequately to qualified beneficiaries, and other issued by the Department shortly after cover every circumstance, or even the persons acting on their behalf to plan the enactment of COBRA, which most frequent circumstances, under administrators. provided a model general notice to be which COBRA continuation coverage The regulations contain one exception used in connection with plans’ first might be denied or terminated before to this general rule. Section 2590.606– becoming covered by COBRA.20 The the end of its maximum period. 4(b) expressly provides that the 14-day Department also stated in the proposal that, in the absence of final regulations, C. Standards for Furnishing Notices time limit applicable to plan administrators for furnishing an election the Department would judge plan As discussed above, the final notice will not begin to run until a plan compliance with the COBRA statutory regulations provide standards for a administrator actually receives a notice notice requirements under the standard variety of notices required to be furnished in accordance with the set by the COBRA conference report: furnished by and to qualified requirements of § 2590.606–2 or ‘‘[E]mployers are required to operate in beneficiaries, employers, and plan § 2590.606–3. good faith compliance with a reasonable administrators. Several commenters interpretation of these substantive rules, requested further guidance on the D. Effective and Applicability Dates notice requirements, etc.’’21 Several acceptable methods for furnishing the The Department received a number of commenters have requested guidance various notices addressed by the comments expressing concern about the from the Department on whether, in the regulations. They also requested proposal’s statement of the interim between issuance of the guidance on how to determine, for Department’s intention to make final proposed regulations and a future purposes of the various time limits, regulations effective and applicable as applicability date for new final rules, when a notice should be considered to of the first day of the first plan year they could rely on the proposed be furnished. occurring on or after January 1, 2004. regulations as a reasonable The Department generally recognizes Commenters argued that such a short interpretation of the COBRA statutory that disclosures may be furnished time period between publication and notice requirements that would be through a number of different methods. effective dates would not provide group viewed by the Department as good faith See § 2520.104b–1(b) (describing health plans sufficient time for an compliance. The Department has generally appropriate methods for orderly implementation of the changes determined that it is in the public furnishing reports, statements, notices, necessary to accommodate the final interest to encourage early compliance and other documents required under COBRA continuation coverage notice with these new standards and, therefore, title I to individuals). With regard to regulations. The Department recognizes will, pending the applicability of the general notices, election notices, the importance of providing plans with final rules, view compliance with either unavailability notices, and early the proposed rules or the final rules, termination notices, each of which is an adequate period for making the changes to their COBRA processes including use of the model notices as required to be furnished by the plan proposed or as finalized, to constitute administrator, the final regulations required by these final COBRA notice regulations. It is in the public interest to good faith compliance with the COBRA expressly provide that such notices statutory notice requirements. must be furnished in a manner enable plans to come into compliance consistent with the standards set out in smoothly and economically and to take E. Regulatory Impact Analysis advantage of the additional § 2520.104b–1(b). See § 2590.606–1(f); Summary § 2590.606–4(f). opportunities for administrative Under the standards set by efficiency provided by these regulations. The regulatory standards promulgated § 2520.104b–1(b), and therefore under Accordingly, the Department has in these regulations will benefit both these regulations, a required notice determined to provide a period of at 19 generally should be considered least six months after publication of In response to public concerns about the these final regulations before they will proposed effective date, the Department issued a ‘‘furnished’’ by a plan administrator as press release expressing its intention to give group of the date of mailing, if mailed by first be applicable to notice obligations health plans six months after the adoption of final class mail, certified mail, or Express arising under group health plans. rules to implement administrative changes required Mail; or as of the date of electronic In order to avoid confusion by the new rules. Press Release, EBSA, Labor concerning the applicability date of the Department Announces Proposed Effective Date of transmission, if transmitted COBRA Regulations Will Be Delayed (September 17, electronically.17 When hand delivery is final rules, each rule (§§ 2590.606–1 2003). the chosen method of delivery, through 2590.606–4) has been modified 20 The preamble to the proposed COBRA notice however, a notice would not be to add a new ‘‘applicability’’ paragraph. regulations explained that the early guidance and This paragraph provides that the model general notice contained in Technical considered furnished until actually Release 86–2, issued June 26, 1986, no longer regulation applies to notice obligations adequately reflected the COBRA provisions due to 17 See § 2520.104b–1(c) (disclosure through that arise on or after the first day of the subsequent amendments and that use of that model electronic media). The Department recognizes that notice would no longer be considered good faith other methods of furnishing may be available that, 18 The use of interoffice mail for purposes of compliance with the requirements of section under the actual facts and circumstances, should be providing a notice to an employee should be 606(a)(1) of the Act. See 68 FR 31832, 31834 n.13 accorded the same deference as electronic considered tantamount to hand delivery and (May 28, 2003). transmission and first class mail. governed by the same standards. 21 H.R. Conf. Rep. No. 99–453 at 563.

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plan sponsors and participants. They environment, public health or safety, or because the majority of notice will dispel plan administrators’ State, local or tribal governments or obligations are met through the uncertainty about how to comply with communities (also referred to as purchase of COBRA administrative COBRA notice provisions and reduce ‘‘economically significant’’); (2) creating services from a number of COBRA the risk of inadvertent violations. They serious inconsistency or otherwise administrators that is small relative to will help participants and beneficiaries interfering with an action taken or the number of group health plans they understand how to exercise their planned by another agency; (3) serve. In addition, not all COBRA COBRA rights, thereby averting costly materially altering the budgetary administrators or plans will be required disputes and lost opportunities to elect impacts of entitlement grants, user fees, to make substantial changes. In COBRA coverage. This will result in an or loan programs or the rights and estimating the impact of the proposed increase in the number of COBRA obligations of recipients thereof; or (4) regulations and model forms, the elections by qualified beneficiaries. raising novel legal or policy issues Department assumed that many COBRA These benefits of the regulations are arising out of legal mandates, the administrators and plans currently use expected to outweigh their costs. President’s priorities, or the principles notices that, for the most part, are in New administrative costs imposed by set forth in the Executive Order. compliance with the requirements of the these regulations are limited because Pursuant to the terms of the Executive regulations. Comments received did not plan sponsors and administrators Order, it has been determined that this support a revision of that assumption already distribute notices pursuant to action is ‘‘significant’’ within the for the estimate of the economic impact the COBRA statute, and many of their meaning of section 3(f)(4) of the of the final rule. In response to existing practices likely already satisfy Executive Order and therefore subject to comments, however, the Department the requirements of these regulations. review by the Office of Management and has made certain clarifications to the The Department estimates the new Budget (OMB). proposed regulations with respect to administrative costs to be $2.6 million Costs.—The administrative cost of content and format of the notices and in the first year that the regulations are these regulations is expected to be has clarified the model notices effective and $0.9 million annually in modest, primarily because COBRA’s accordingly. These changes, discussed subsequent years. The $0.9 million statutory provisions have been in effect more fully earlier in the preamble, will ongoing annual cost is attributable to since 1986. As a result, most group expand opportunities for COBRA the new requirements to notify qualified health plans, plan administrators, and administrators to fulfill plans’ COBRA beneficiaries when continuation health insurance issuers already have notice obligations within the context of coverage is unavailable or has been developed forms and procedures for the their current practices. The clarification terminated before the maximum period administration of COBRA notices. The of the scope of applicability of the of coverage has ended. The remaining Department estimates that the unavailability notice in § 2590.606–4(c) $1.7 million first-year cost reflects the regulations will increase administrative has resulted in an increase in the cost to plans to review existing notices costs by $2.6 million in the first year estimated cost of the final regulations of and procedures, to make any necessary and $0.9 million annually in subsequent $204,000. revisions, and to modify or develop years. The Department expects the number newly required notices. Commenters on the proposed of COBRA elections to increase slightly The Department also expects the regulations remarked in general terms as a result of the implementation of number of COBRA elections to increase on the importance of controlling costs in these final regulations. Consequently, a slightly, by between 0.5 percent and 1.0 relation to the benefits achieved for portion of the cost of health care percent, which will increase costs to qualified beneficiaries. One commenter coverage will transfer from those new employers. Employers can charge indicated that revising automated COBRA enrollees to plan sponsors, COBRA enrollees the cost of coverage systems that generate COBRA notices thereby increasing the subsidy from plus an administrative charge, but those would be more costly than the employers to COBRA enrollees. The electing continuation coverage tend to Department had estimated in transfer of costs arises because surveys have higher costs and therefore as a connection with the proposal because indicate that although qualified group enjoy a subsidy from plan many COBRA administrators currently beneficiaries that elect COBRA coverage sponsors equal to about one-third of the issue COBRA notices that narrowly pay a cost consisting of the applicable cost of their coverage. If COBRA target individual audiences, such as premium amount for group coverage elections increase, the amount of the spouses or children. Although some plus an administrative charge, the actual subsidy will increase by a similar COBRA administrators choose to average cost of continuation coverage is proportion, or between $12 million and include additional information in their somewhat higher than the combined $24 million annually. notices for certain types of qualified amount paid by the qualified beneficiaries, the Department continues beneficiary. Payment by a plan sponsor Executive Order 12866 to believe that few COBRA of the difference in these costs Under Executive Order 12866, the administrators will be required to make constitutes a subsidy of a qualified Department must determine whether the significant changes in order to comply beneficiary’s continuation coverage. As regulatory action is ‘‘significant’’ and with the basic requirements of these such, the transfer represents a cost to therefore subject to the requirements of notice provisions. COBRA plan sponsors and a benefit to COBRA the Executive Order and subject to administrators have in place processes enrollees. review by the Office of Management and that are, in fact, flexible enough to In estimating the amount of the Budget (OMB). Under section 3(f), the provide notices that satisfy the need for transfer, the Department observed that order defines a ‘‘significant regulatory a generic product suitable for use by the number of inquiries the Department action’’ as an action that is likely to multiple plans while remaining receives annually concerning COBRA, result in a rule’s (1) having an annual sufficiently adaptable to include about 59,000, is equivalent to just more effect on the economy of $100 million detailed information unique to the plan than 1 percent of the estimated 5 or more, or adversely and materially or individual qualified beneficiary. million annual COBRA qualifying affecting a sector of the economy, Economies of scale also tend to events. It is likely that some but not all productivity, competition, jobs, the moderate COBRA administrative costs of these inquiries reflect notice

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inadequacies that these regulations resources by both plan administrators comments on the proposed regulations. would correct. The Department also and participants and beneficiaries to Accordingly, the Department has noted that approximately 19 percent of resolve. Although the magnitude of the submitted the ICR included in the qualifying events result in elections, and costs and potential savings associated Notice of Final Regulations for review that the average annualized subsidy with administrative inefficiencies is and clearance by OMB. from plan sponsors to COBRA enrollees unknown, clearer and more uniform The Department has issued these amounts to about $2,500 per enrollee. If standards should serve to avoid the rules to set minimum standards for the between 0.5 percent and 1.0 percent of otherwise unnecessary expense timing and content of the notices qualifying events involve missed associated with rectifying procedural required under the continuation opportunities due to inadequate notice, and substantive notice inadequacies. coverage provisions of part 6 of title I of and 19 percent of those events would Providing greater certainty to plan ERISA, and to establish uniform have resulted in elections, then the sponsors and plan administrators as to standards for administering the notice regulations, by correcting notice how their notice obligations can be met process. In very general terms, the deficiencies, would increase COBRA should also limit risks to both plans and statute requires that qualified enrollees by between 4,750 and 9,500 qualified beneficiaries. Plan sponsors beneficiaries be offered the opportunity each year, and the aggregate subsidy by and plan administrators who comply to elect to continue group health between $12 million and $24 million. with this guidance will be less likely to coverage after losses of coverage due to Expressed in unit costs, for every one be subjected to costly disputes, death of the covered employee, percent increase in the number of litigation, or penalties as a result of their termination of employment or reduction qualified beneficiaries who elect compliance with this guidance. of hours of employment, divorce or legal continuation coverage due to improved The benefit to COBRA enrollees separation of the covered employee notices and procedures, there is an exceeds the financial value of the from the employee’s spouse, loss of estimated incremental increase in cost transfer insofar as the enrollees will gain dependent child status, the covered of $24 million to plan sponsors or an access to high-value group coverage employee’s becoming entitled to average of approximately $58 per plan. rather than having to choose between Medicare, or bankruptcy of an employer Both the administrative cost and the purchasing generally lower-value that affects covered retirees and their transfer cost will be borne by the individual insurance, usually at a families. Qualified beneficiaries may 411,000 group health plans, covering a significantly higher rate than a group include covered employees, spouses of total of about 111 million participants rate, or going without coverage covered employees, and dependent and their dependents, that are currently altogether. Individual coverage is more children of covered employees. required to offer continuation coverage. costly and less efficient due in large part Coverage generally extends for up to 18 Cost estimates recognize only the cost of to significantly higher costs of or 36 months, depending on the nature changes to existing practices that are individual policy administration. The of the qualifying event. likely to be associated with these rules; uninsured are also known to seek The regulations set standards for six they exclude the pre-regulation impact preventive care less frequently and to types of notices and provide two model of the statute itself. Estimates are delay or forgo treatment, which may notices in the following sections: grounded in an assumption as to the lead to less favorable health outcomes General Notice of Continuation entity expected to perform the needed and higher social costs for acute care at Coverage; Notice Requirements for work (e.g., a health insurer or a later time. Interruptions in group Employers; Notice Requirements for professional administrator); the health plan coverage can ultimately Covered Employees and Qualified assumption should not be interpreted to limit the portability of group coverage, Beneficiaries; and Notice Requirements bear on any party’s legal responsibility as well. A reduction in the numbers of for Plan Administrators. The last section for COBRA compliance. The costs of the losses of coverage that result from covers a notice of right to elect regulations are equal to only one one- notification failures results in efficiency continuation coverage, a notice of hundredth of 1 percent or less of total gains to the extent that the qualified unavailability of continuation coverage, group health plan costs to entities beneficiaries elect group health plan and a notice of early termination of subject to COBRA. Because the coverage rather than individual continuation coverage. Each of the magnitude of the overall increase in coverage. regulations includes one or more ICRs. costs to plans is small, the Department It should be noted that this Paperwork Paperwork Reduction Act believes that it will not have a Reduction Act analysis includes the cost consequential effect on the availability In accordance with the Paperwork of the statute (the COBRA provisions) as of health coverage for employees. Reduction Act of 1995 (44 U.S.C. 3501– well as the cost of the discretion Benefits.—The benefits of these rules 3520) (PRA 95), the Department exercised in this rulemaking. These arise from improved administrative submitted the information collection costs were developed in the manner efficiency, reduced exposure to risk, and request (ICR) included in the Notice described below. from the potential avoidance of some Requirements of the Health Care In order to develop estimates of the unnecessary losses of group health plan Continuation Coverage Provisions to the cost of the review, revision, coverage by qualified beneficiaries. Office of Management and Budget development, and distribution of Improvements in the consistency and (OMB) for review and clearance at the COBRA notices, it was first necessary to quality of information provided to time the Notice of Proposed Rulemaking determine the numbers of participants participants and beneficiaries will help (NPRM) was published. In accordance and beneficiaries in plans that are them understand their rights and limit with 5 CFR 1320.11(c) of the PRA, OMB required to offer COBRA coverage their risk of losing the opportunity to issued a Notice of Action, on June 6, (generally, plans sponsored by elect COBRA coverage. Inconsistent 2003, deferring action on the request for employers with 20 or more employees), procedures and notices that are not approval until the submission of the ICR the numbers of beneficiaries who reside adequate as to content, timing, and form in connection with the final rulemaking. at addresses that are different from are known to generate questions, delays, Action was deferred in order to provide related covered employees, and the rates disputes, and duplications of effort that the Department with an opportunity to of occurrences of qualifying events that require the expenditure of additional include changes resulting from give rise to notice obligations. Also

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required were estimates of the number unavailability notices. The costs for service providers, or 90 providers, will of entities, such as group health completing and distributing notices are be affected. insurance issuers and professional ongoing operating costs. Modifications to the general notice administrators, that would review The Department has assumed that all and the election notice are assumed to COBRA notices; the number that would COBRA administrators will review their require two hours per notice, at $68 per consequently revise COBRA notices; existing forms and procedures in hour for a service provider. Additional and the time required to do so for each response to promulgation of this start-up costs include the cost of four type of notice. guidance, and that some of those plan hours of professional time, at $68 per The Department derived its estimates administrators will need to revise their hour, to modify or develop the employer of 55.8 million covered employees, 55 notices and procedures. In order to and employee notices and to develop million beneficiaries, and 2.5 million derive an estimate of the number of the two newly required early COBRA enrollees from the February and entities that will review forms and termination and unavailability notices. March 2001 Current Population Survey procedures, the Department looked at Ongoing operating costs arise from (CPS; Census Bureau household the number of health insurers offering completing a notice upon the surveys), the 2000 Medical Expenditure group products and the number of occurrence of each event that gives rise Panel Survey, Household and Insurance professional administrators providing to a notice obligation and from Components (MEPS comprises surveys services to group health plans. This distributing the completed notice. The of households and private results in an estimate of about 3,000 Department did not attribute any establishments conducted jointly by the entities that perform COBRA ongoing operating cost to the provision Census Bureau and the Agency for administration for the majority of all of the general notice to covered Healthcare Research and Quality), and plans. All of these entities are expected employees and their spouses who reside the 1996 Panel of the Survey of Income to review all of their notices and with them. Under this final rule, a plan and Program Participation (SIPP; a procedures in response to this administrator may satisfy the general Census Bureau longitudinal household regulatory guidance. The reviews are notice requirement by including the survey). These data sources also assumed to require 2 hours each for the required content in the SPD and indicate that 67,000 dependents live general notice and the election notice. furnishing a single notice addressed to outside the household of related The reviews are expected to be both the covered employee and the employees. Frequency rates for conducted by professionals at the level covered employee’s spouse. The qualifying events were also developed of financial managers at a cost of $68 Department did, however, attribute an from MEPS and SIPP. per hour. ongoing operating cost to completing An estimate of the number of plans In order to estimate the number of and distributing the general notice to a covering these employees and service providers that would be required spouse of a covered employee who dependents was also needed. About to revise their existing notices, the resides at a separate address. 50,000 group health plans currently file Department first examined its data No burden is included for completing the Form 5500–Annual Return/Report of pertaining to the nature of the telephone the employer’s notice because it Employee Benefit Plan each year, inquiries it receives. These data show involves only information that the including 38,000 large plans, and 8,000 that about 59,000 inquiries pertaining to employer has at hand in its customary small plans, and a number of plans that COBRA are received each year. personnel practices. Similarly, no may not be required to file. For the Although the portion of these inquiries completion burden is calculated for the purpose of regulatory analysis, plans that pertain to notice provisions is qualified beneficiaries’ notices because with fewer than 100 participants are unknown, as is the number of COBRA this information is limited, readily considered to be small. Because the notification issues that do not give rise available, and would be provided as a majority of small group health plans are to contact with the Department, this usual practice by only the qualified not required to file Form 5500, the number provides the only available beneficiary who wishes to elect number of such plans must be estimated proxy for a rate of notice-related continuation coverage. from other data sources. CPS and MEPS difficulties. Given the roughly 5 million No cost has been included for the data were used to derive an estimate of COBRA election notices provided each completion or distribution of the notice the number of employers that offer year, the rate of notice inadequacies is of unavailability of continuation group health coverage, and to exclude assumed to be about 1%. Because some coverage because there is currently no employers within that group that have COBRA inquiries received by the basis for determining the number of fewer than 20 employees. This estimate Department pertain to issues other than these notices that might be sent. The indicates that these regulations will notices, the number of inadequate Department has assumed, however, that affect about 411,000 plans, 38,000 of notices may range from .5% to 1% but due to the clear and consistent which are large, and 373,000 of which 1% has been used for purposes of these information provided in the general are small. The number of participants in estimates. notice, plan administrators will large plans is estimated at 43.5 million. These regulations will require service distribute only a limited number of The number of participants in small providers to revise the .5% to 1% of unavailability notices annually and that plans is estimated to be 12.3 million. notices that historically have been the associated cost will be very small. The preparation and distribution of inadequate. The cost of these revisions Finally, the cost for completing the notices (discussed below) is accounted will be driven in part by the number of election notice, at 4 minutes per notice, for as cost rather than hours because service providers affected. The and the early termination notice, at 1 most COBRA administration is proportion of service providers affected minute per notice, is estimated at $34 accomplished through the purchase of may be larger than the proportion of per hour. The 4 minutes required to services for which fees are paid. Start- notices that are inadequate. If complete an election notice represent a up costs that arise from these inadequate notices are concentrated reduction from the 5 minutes originally regulations pertain to the review and among smaller service providers, then calculated in the proposed regulation. revision of existing forms and the proportion of service providers The one minute saved as a result of procedures and the development of the affected will be more than .5% to 1%. clarifications in the final regulations new early termination and The Department assumed that 3% of all regarding how plans may identify

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qualified beneficiaries for purposes of Total Burden Cost (Operating and appropriateness of the size standard the election notice, is expected to Maintenance): $14,723,400. used in evaluating the impact of this reduce the burden for completing Total Annualized Cost: $16,379,900. rule on small entities. No comments election forms. As such, the estimated Regulatory Flexibility Act were received. operating and maintenance costs for the On the basis of this definition, EBSA ICR have been reduced by an estimated The Regulatory Flexibility Act (5 estimates that the regulations will not $2.7 million. U.S.C. 601 et seq.) (RFA) imposes have a significant impact on a In determining the cost for certain requirements with respect to substantial number of small entities. In distribution of COBRA notices, the federal rules that are subject to the support of this conclusion, the Department noted in the proposed notice and comment requirements of Department has conducted a final regulations that due to the nature of the section 553(b) of the Administrative regulatory flexibility analysis, which is rights and obligations involved in Procedure Act (5 U.S.C. 551 et seq.) and summarized below. COBRA notice requirements most plan that are likely to have a significant These regulations provide plans and administrators tend not to choose economic impact on a substantial qualified beneficiaries with greater electronic distribution methods for number of small entities. Unless an certainty as to how the notice COBRA notices. The Department further agency certifies that a rule will not have obligations of COBRA can be met. noted that plans are not precluded from a significant economic impact on a Inquiries to the Department, as well as using electronic distribution methods substantial number of small entities, public comment in response to the 1997 that comply with regulations at 29 section 604 of the RFA requires that the RFI, indicated that service providers agency present a final regulatory CFR.104b–1(b) and (c) and specifically and plan administrators would welcome flexibility analysis at the time of the requested comment on the use of guidance that would provide greater publication of the NFRM describing the electronic technologies in COBRA administrative efficiency and reduce impact of the rule on small entities. notice administration. The Department exposure to risk resulting from Small entities include small businesses, received one comment attesting to the procedural or substantive failures to organizations, and governmental availability of electronic information meet notification requirements. jurisdictions. Improvements in the quality of systems that are capable of transmitting For purposes of analysis under the COBRA notices and disclosures, and information provided to participants RFA, EBSA proposes to continue to and beneficiaries is expected to help that are efficient, legally protective, and consider a small entity to be an cost effective. The Department them understand their rights and limit employee benefit plan with fewer than their risk of losing the opportunity to recognizes that there may be cost 100 participants. The basis of this elect the COBRA coverage that is savings when information is transmitted definition is found in section 104(a)(2) required to be offered. electronically and that some plans may of the Act, which permits the Secretary The COBRA provisions require a choose to use electronic technologies to to prescribe simplified annual reports group health plan to offer qualified fulfill their requirements. For purposes for pension plans that cover fewer than beneficiaries the opportunity to elect of the PRA, however, the Department 100 participants. Under section continuation coverage when they would has conservatively estimated costs based 104(a)(3), the Secretary may also otherwise lose group health coverage as on first-class mail, which is currently provide for exemptions or simplified a result of certain events described in the most common method for delivery annual reporting and disclosure the statute as ‘‘qualifying events.’’ of COBRA information. Postage and requirements for welfare benefit plans. Under section 608 of ERISA, the materials for distribution are estimated Pursuant to the authority of section Secretary has the authority to carry out at $0.38 per notice. No assumption has 104(a)(3), the Department has the provisions of part 6 of title I of been made as to the number of these previously issued regulations at 29 CFR ERISA. Further, the Conference Report notices that will be distributed 2520.104–20, 2520.104–21, 2520.104– that accompanied COBRA provided that electronically. The application of these 41, 2520.104–46, and 2520.104b–10, the Secretary has the authority to issue assumptions results in an estimated providing for simplified reporting regulations implementing the notice and annual distribution of 66,900 general requirements and limited exemptions disclosure provisions of part 6 of ERISA. notices, 2,809,000 employer notices, from reporting and disclosure The Department’s objective in issuing 651,000 qualified beneficiary notices, requirements for small plans, including the regulations is to provide guidelines 4,699,000 plan administrator election unfunded or insured welfare plans that will assure plan administrators that notices, and 1,000,000 early termination covering fewer than 100 participants, they are in compliance with the notices. The number of unavailability that satisfy certain other requirements. notification provisions of COBRA and notices is unknown. Further, while some large employers that participants and beneficiaries have Type of Review: New collection. may have small plans, in general most sufficient information to exercise their Agency: Employee Benefits Security small plans are maintained by small COBRA rights. Small plans will benefit Administration, Department of Labor. employers. Thus, EBSA believes that from clarifications about the content Title: Notice Requirements of the assessing the impact of this rule on and timing of notices and from the Health Care Continuation Coverage small plans is an appropriate substitute likelihood that fewer determinations Provisions. for evaluating the effect on small about COBRA coverage will be delayed, OMB Number: 1210–0NEW. entities. The definition of small entity disputed, or appealed. In addition, an Affected Public: Individuals or considered appropriate for this purpose increased number of qualified households; Business or other for-profit; differs, however, from a definition of beneficiaries in small health plans will Not-for-profit institutions. small business based on size standards be able to obtain COBRA continuation Respondents: 411,000. promulgated by the Small Business coverage. Frequency of Response: On occasion. Administration (SBA) (13 CFR 121.201) The Department believes that, because Responses: 9,225,900. pursuant to the Small Business Act (15 of the expertise required, small plans Estimated Total Burden Hours: None. U.S.C. 631 et seq.). At the time of the will use COBRA administrators to Total Annualized Capital/Startup publication of the NPRM, the review notices and to modify or adapt Costs: 1,656,500. Department requested comments on the the Department’s model notices for use

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by the plan administrator. Generally, cannot reasonably be determined; it is Unfunded Mandates Reform Act COBRA administrators offer plans on- expected, however, that, with the For purposes of the Unfunded going administrative services, such as additional clarity provided by the Mandates Reform Act of 1995 (Pub. L. notifying employees about their group general notice regulation, the number of 104–4), as well as Executive Order health plan continuation coverage, unavailability notices required to be 12875, this rule does not include any distributing and processing election sent will be small. The total cost to federal mandate that may result in forms, collecting and applying premium small plans for a service provider’s expenditures by state, local, or tribal payments, and monitoring COBRA assistance in reviewing, modifying, or governments in the aggregate of more compliance. Small plans, in particular, developing notices is estimated to be than $100 million, or increased are less likely to have in-house $575,300, or $1.54 per small plan. The expenditures by the private sector of capabilities to handle these comparable average cost to large plans more than $100 million. administrative tasks. For a service is $53.09 per plan. provider, reviewing and adopting or Employers with small plans will also Small Business Regulatory Enforcement modifying forms for plans will result in incur transfer costs as a result of an Fairness Act increase in the number of elections of some direct cost. COBRA administrators The rule being issued here is subject continuation coverage by qualified may choose to absorb some of the cost to the Congressional Review Act in order to maintain competitive beneficiaries who would have lost the provisions of the Small Business products; others may charge the cost to opportunity to elect COBRA coverage Regulatory Enforcement Fairness Act of their client plans. Where these costs are absent improved notices and 1996 (5 U.S.C. 801 et seq.) and has been charged to plans, the cost will most procedures. A portion of the cost of transmitted to Congress and the likely be minimized because of the health care coverage previously borne Comptroller General for review. The economies of scale inherent in the use by these individuals will be transferred rule is not a ‘‘major rule,’’ as that term of standardized forms and procedures. to plan sponsors. However, because is defined in 5 U.S.C. 804, because it is Costs to small plans are further reduced there are fewer participants in small not likely to result in (1) an annual because of the large number of small plans, the per-plan transfer costs are effect on the economy of $100 million plans that share the cost burden; there considerably less than for large plans. are approximately seven times as many The potential transfer cost to small or more; (2) a major increase in costs or small plans as large plans. Finally, to plans is estimated to range between $2.6 prices for consumers, individual further reduce costs, the Department has million and $5.2 million, depending on industries, or Federal, State, or local provided two model notices that can be the number of qualified beneficiaries government agencies, or geographic adapted by COBRA administrators for who will elect COBRA coverage. The regions; or (3) significant adverse effects use by individual single-employer rate of potential losses of opportunity to on competition, employment, plans. elect COBRA coverage is estimated to investment, productivity, innovation, or The Department estimates that there fall between .5% and 1%. This on the ability of United States-based are approximately 2.5 million plans, represents an average of $7 to $14 per enterprises to compete with foreign- each with fewer than 100 participants, small plan. The comparable cost to large based enterprises in domestic or export that are considered small group health plans ranges from $9.4 million to $18.7 markets. plans under the Department’s million, an average of $242 to $484 per Federalism Statement definition. Among these, COBRA plan. At the upper bound, the total applies to only those plans with 20 or estimated cost of the regulations for Executive Order 13132 (Aug. 4, 1999) more employees, or 373,000 plans, with 373,000 small plans is $5.7 million, or outlines fundamental principles of a total of approximately 12.3 million an average of $15 per plan. federalism and requires the adherence participants. While the majority of The basis for the regulations lies in to specific criteria by Federal agencies group health plans subject to COBRA the notice and disclosure provisions of in the process of their formulation and are small plans, participation in those part 6 of title I of ERISA. The implementation of policies that have plans represents only about 22% of regulations do not duplicate, overlap, or substantial direct effects on the States, participation in all plans covered by conflict with other Federal rules. The the relationship between the national COBRA. COBRA provisions have been in effect government and the States, or on the The cost estimates for small plan for many years. Accordingly, most plan distribution of power and compliance recognize only the cost of administrators and COBRA responsibilities among the various changes to existing practices associated administrators have developed levels of government. This rule does not with the regulations; they exclude the procedures to comply with their have federalism implications because it impact of the statute itself. Costs result statutory obligations. The regulations has no substantial direct effect on the from the likelihood that COBRA merely seek to provide additional, States, on the relationship between the administrators may be required to detailed guidance that will clarify a national government and the States, or modify two notices currently used by plan’s administrative obligations and on the distribution of power and plans and may modify or develop other assure plan administrators and COBRA responsibilities among the various notices, including the two new early administrators that, in complying with levels of government. Section 514 of termination and unavailability notices. the regulations, they have satisfied their ERISA provides, with certain exceptions The cost to small group health plans to statutory obligations. specifically enumerated, that the review and modify existing notices is The Department has attempted to provisions of titles I and IV of ERISA estimated at $275,900. The cost to minimize the burden of the review and supersede any and all laws of the States develop the two new notices and to potential revision of existing notices as they relate to any employee benefit complete and distribute the early undertaken in response to this guidance plan covered under ERISA. The termination notice is estimated at by including model notices that can be requirements implemented in this rule $299,400. No costs have been estimated adapted to plans’ specific do not alter the fundamental provisions for completion and distribution of the circumstances. This should lessen the of the statute with respect to employee unavailability notice because the use of resources for small and large benefit plans, and as such would have number of notices that might be sent plans alike. no implications for the States or the

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relationship or distribution of power employee, spouse, or dependent child of (5) An explanation of the importance between the national government and such employee notice of a qualified of keeping the administrator informed of the States. beneficiary’s right to elect continuation the current addresses of all participants coverage. or beneficiaries under the plan who are List of Subjects in 29 CFR Part 2590 (2) A notice that is furnished in or may become qualified beneficiaries; Continuation coverage, Disclosure, accordance with paragraph (b)(1) of this and Employee benefit plans, Group health section shall, for purposes of section (6) A statement that the notice does plans, Health care, Medical child 606(a)(1) of the Act, be deemed to be not fully describe continuation coverage support, Reporting and recordkeeping provided at the time of commencement or other rights under the plan and that requirements. of coverage under the plan. more complete information regarding I For the reasons set forth in the (3) In any case in which an such rights is available from the plan preamble, the Department amends administrator is required to furnish a administrator and in the plan’s SPD. chapter XXV, subchapter L, part 2590 of notice to a covered employee or spouse (d) Single notice rule. A plan title 29 of the Code of Federal pursuant to paragraph (b)(1)(ii) of this administrator may satisfy the Regulations as follows: section, the furnishing of a notice to requirement to provide notice in such individual in accordance with accordance with this section to a Subchapter L—Group Health Plans § 2590.606–4(b) shall be deemed to covered employee and the covered satisfy the requirements of this section. employee’s spouse by furnishing a PART 2590—RULES AND (c) Content of notice. The notice single notice addressed to both the REGULATIONS FOR GROUP HEALTH required by paragraph (a) of this section covered employee and the covered PLANS shall be written in a manner calculated employee’s spouse, if, on the basis of to be understood by the average plan the most recent information available to I 1. The heading of subchapter L is participant and shall contain the the plan, the covered employee’s spouse revised to read as shown above. following information: resides at the same location as the I 2. The heading of part 2590 is revised (1) The name of the plan under which covered employee, and the spouse’s to read as shown above. continuation coverage is available, and coverage under the plan commences on I 3. The authority citation for part 2590 the name, address and telephone or after the date on which the covered is revised to read as follows: number of a party or parties from whom employee’s coverage commences, but Authority: 29 U.S.C. 1027, 1059, 1135, additional information about the plan not later than the date on which the 1161–1168, 1169, 1181–1183, 1185, 1185a, and continuation coverage can be notice required by this section is 1185b, 1191, 1191a, 1191b, and 1191c; sec. obtained; required to be provided to the covered 401(b), Pub. L. 105–200, 112 Stat. 645; and (2) A general description of the employee. Nothing in this section shall Secretary of Labor’s Order No. 1–2003, 68 FR continuation coverage under the plan, be construed to create a requirement to 5374 (Feb. 3, 2003). including identification of the classes of provide a separate notice to dependent individuals who may become qualified Subpart A—[Amended] children who share a residence with a beneficiaries, the types of qualifying covered employer or a covered I 4. Part 290, Subpart A, is amended by events that may give rise to the right to employee’s spouse to whom notice is adding §§ 2590.606–1 through continuation coverage, the obligation of provided in accordance with this 2590.606–4 to read as follows: the employer to notify the plan section. administrator of the occurrence of (e) Notice in summary plan § 2590.606–1. General notice of certain qualifying events, the maximum description. A plan administrator may continuation coverage. period for which continuation coverage satisfy the requirement to provide notice (a) General. Pursuant to section may be available, when and under what in accordance with this section by 606(a)(1) of the Employee Retirement circumstances continuation coverage including the information described in Income Security Act of 1974, as may be extended beyond the applicable paragraphs (c)(1), (2), (3), (4), and (5) of amended (the Act), the administrator of maximum period, and the plan’s this section in a summary plan a group health plan subject to the requirements applicable to the payment description meeting the requirements of continuation coverage requirements of of premiums for continuation coverage; § 2520.102–3 of this chapter furnished part 6 of title I of the Act shall provide, (3) An explanation of the plan’s in accordance with paragraph (b) of this in accordance with this section, written requirements regarding the section. notice to each covered employee and responsibility of a qualified beneficiary (f) Delivery of notice. The notice spouse of the covered employee (if any) to notify the administrator of a required by this section shall be of the right to continuation coverage qualifying event that is a divorce, legal furnished in a manner consistent with provided under the plan. separation, or a child’s ceasing to be a the requirements of § 2520.104b–1 of (b) Timing of notice. (1) The notice dependent under the terms of the plan, this chapter, including paragraph (c) of required by paragraph (a) of this section and a description of the plan’s that section relating to the use of shall be furnished to each employee and procedures for providing such notice; electronic media. each employee’s spouse, not later than (4) An explanation of the plan’s (g) Model notice. The appendix to this the earlier of: requirements regarding the section contains a model notice that is (i) The date that is 90 days after the responsibility of qualified beneficiaries intended to assist administrators in date on which such individual’s who are receiving continuation coverage discharging the notice obligations of this coverage under the plan commences, or, to provide notice to the administrator of section. Use of the model notice is not if later, the date that is 90 days after the a determination by the Social Security mandatory. The model notice reflects date on which the plan first becomes Administration, under title II or XVI of the requirements of this section as they subject to the continuation coverage the Social Security Act (42 U.S.C. 401 would apply to single-employer group requirements; or et seq. or 1381 et seq.), that a qualified health plans and must be modified if (ii) The first date on which the beneficiary is disabled, and a used to provide notice with respect to administrator is required, pursuant to description of the plan’s procedures for other types of group health plans, such § 2590.606–4(b), to furnish the covered providing such notice; as multiemployer plans or plans

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established and maintained by applicable plan provisions. Items of (h) Applicability. This section shall employee organizations for their information that are not applicable to a apply to any notice obligation described members. In order to use the model particular plan may be deleted. Use of in this section that arises on or after the notice, administrators must the model notice, appropriately first day of the first plan year beginning appropriately add relevant information modified and supplemented, will be on or after November 26, 2004. where indicated in the model notice, deemed to satisfy the notice content BILLING CODE 4510–29–P select among alternative language, and requirements of paragraph (c) of this supplement the model notice to reflect section.

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BILLING CODE 4910–29–C sufficient information to enable the title II or XVI of the Social Security Act § 2590.606–2. Notice requirement for administrator to determine the plan, the (42 U.S.C. 401 et seq. or 1381 et seq.) employers. covered employee, the qualifying event, (SSA), to be disabled at any time during (a) General. Pursuant to section and the date of the qualifying event. the first 60 days of continuation 606(a)(2) of the Employee Retirement (d) Multiemployer plan special rules. coverage; and (5) Notice that a qualified beneficiary, Income Security Act of 1974, as This section shall not apply to any with respect to whom a notice described amended (the Act), except as otherwise employer that maintains a in paragraph (a)(4) of this section has provided herein, the employer of a multiemployer plan, with respect to been provided, has subsequently been covered employee under a group health qualifying events affecting coverage determined by the Social Security plan subject to the continuation under such plan, if the plan provides, Administration, under title II or XVI of coverage requirements of part 6 of title pursuant to section 606(b) of the Act, the SSA to no longer be disabled. I of the Act shall provide, in accordance that the administrator shall determine whether such a qualifying event has (b) Reasonable procedures. (1) A plan with this section, notice to the subject to the continuation coverage administrator of the plan of the occurred. (e) Applicability. This section shall requirements shall establish reasonable occurrence of a qualifying event that is apply to any notice obligation described procedures for the furnishing of the the covered employee’s death, in this section that arises on or after the notices described in paragraph (a) of termination of employment (other than first day of the first plan year beginning this section. by reason of gross misconduct), on or after November 26, 2004. (2) For purposes of this section, a reduction in hours of employment, plan’s notice procedures shall be Medicare entitlement, or a proceeding § 2590.606–3. Notice requirements for deemed reasonable only if such in a case under title 11, United States covered employees and qualified procedures: Code, with respect to the employer from beneficiaries. (i) Are described in the plan’s whose employment the covered (a) General. In accordance with the summary plan description required by employee retired at any time. authority of sections 505 and 606(a)(3) § 2520.102–3 of this chapter; (b) Timing of notice. The notice of the Employee Retirement Income (ii) Specify the individual or entity required by this section shall be Security Act of 1974, as amended (the designated to receive such notices; furnished to the administrator of the Act), this section sets forth requirements (iii) Specify the means by which plan— for group health plans subject to the notice may be given; (1) In the case of a plan that provides, continuation coverage requirements of (iv) Describe the information with respect to a qualifying event, part 6 of title I of the Act with respect concerning the qualifying event or pursuant to section 607(5) of the Act, to the responsibility of covered determination of disability that the plan that continuation coverage and the employees and qualified beneficiaries to deems necessary in order to provide applicable period for providing notice provide the following notices to continuation coverage rights consistent under section 606(a)(2) of the Act shall administrators: with the requirements of the Act; and commence on the date of loss of (1) Notice of the occurrence of a (v) Comply with the requirements of coverage, not later than 30 days after the qualifying event that is a divorce or paragraphs (c), (d), and (e) of this date on which a qualified beneficiary legal separation of a covered employee section. loses coverage under the plan due to the from his or her spouse; (3) A plan’s procedures will not fail qualifying event; (2) Notice of the occurrence of a to be reasonable, pursuant to this (2) In the case of a multiemployer qualifying event that is a beneficiary’s section, solely because the procedures plan that provides, pursuant to section ceasing to be covered under a plan as a require a covered employee or qualified 606(a)(2) of the Act, for a longer period dependent child of a participant; beneficiary to utilize a specific form to of time within which employers may (3) Notice of the occurrence of a provide notice to the administrator, provide notice of a qualifying event, not second qualifying event after a qualified provided that any such form is easily later than the end of the period beneficiary has become entitled to available, without cost, to covered provided pursuant to the plan’s terms continuation coverage with a maximum employees and qualified beneficiaries. for such notice; and duration of 18 (or 29) months; (4) If a plan has not established (3) In all other cases, not later than 30 (4) Notice that a qualified beneficiary reasonable procedures for providing a days after the date on which the entitled to receive continuation notice required by this section, such qualifying event occurred. coverage with a maximum duration of notice shall be deemed to have been (c) Content of notice. The notice 18 months has been determined by the provided when a written or oral required by this section shall include Social Security Administration, under communication identifying a specific

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event is made in a manner reasonably (B) The date on which a qualifying employee, a qualified beneficiary with calculated to bring the information to event occurs; respect to the qualifying event, or any the attention of any of the following: (C) The date on which the qualified representative acting on behalf of the (i) In the case of a single-employer beneficiary loses (or would lose) covered employee or qualified plan, the person or organizational unit coverage under the plan as a result of beneficiary may provide the notice, and that customarily handles employee the qualifying event; or the provision of notice by one benefits matters of the employer; (D) The date on which the qualified individual shall satisfy any (ii) In the case of a plan to which beneficiary is informed, through the responsibility to provide notice on more than one unaffiliated employer furnishing of the summary plan behalf of all related qualified contributes, or which is established or description or the notice described in beneficiaries with respect to the maintained by an employee § 2590.606–1, of both the responsibility qualifying event. organization, either the joint board, to provide the notice and the plan’s (f) Plan provisions. To the extent that association, committee, or other similar procedures for providing such notice to a plan provides a covered employee or group (or any member of any such the administrator. qualified beneficiary a period of time group) administering the plan, or the (ii) Notwithstanding paragraph longer than that specified in this section person or organizational unit to which (c)(2)(i) of this section, a plan may to provide notice to the administrator, claims for benefits under the plan require the notice described in the terms of the plan shall govern the customarily are referred; or paragraph (a)(4) of this section to be time frame for such notice. furnished before the end of the first 18 (iii) In the case of a plan the benefits (g) Additional rights to continuation months of continuation coverage. of which are provided or administered coverage. Nothing in this section shall by an insurance company, insurance (3) Time limits for notice of change in disability status. The period of time for be construed to preclude a plan from service, or other similar organization providing, in accordance with its terms, subject to regulation under the furnishing the notice described in paragraph (a)(5) of this section may not continuation coverage to a qualified insurance laws of one or more States, beneficiary although a notice the person or organizational unit that end before the date that is 30 days after the later of: requirement of this section was not customarily handles claims for benefits satisfied. under the plan or any officer of the (i) The date of the final determination (h) Applicability. This section shall insurance company, insurance service, by the Social Security Administration, apply to any notice obligation described or other similar organization. under title II or XVI of the SSA, that the (c) Periods of time for providing qualified beneficiary is no longer in this section that arises on or after the notice. A plan may establish a disabled; or first day of the first plan year beginning reasonable period of time for furnishing (ii) The date on which the qualified on or after November 26, 2004. any of the notices described in beneficiary is informed, through the § 2590.606–4. Notice requirements for plan paragraph (a) of this section, provided furnishing of the plan’s summary plan administrators. description or the notice described in that any time limit imposed by the plan (a) General. Pursuant to section with respect to a particular notice may § 2590.606–1, of both the responsibility to provide the notice and the plan’s 606(a)(4) of the Employee Retirement not be shorter than the time limit Income Security Act of 1974, as described in this paragraph (c) with procedures for providing such notice to the administrator. amended (the Act), the administrator of respect to that notice. a group health plan subject to the (1) Time limits for notices of (d) Required contents of notice. (1) A plan may establish reasonable continuation coverage requirements of qualifying events. The period of time for Part 6 of title I of the Act shall provide, furnishing a notice described in requirements for the content of any notice described in this section, in accordance with this section, notice paragraph (a)(1), (2), or (3) of this to each qualified beneficiary of the section may not end before the date that provided that a plan may not deem a notice to have been provided untimely qualified beneficiary’s rights to is 60 days after the latest of: continuation coverage under the plan. (i) The date on which the relevant if such notice, although not containing qualifying event occurs; all of the information required by the (b) Notice of right to elect (ii) The date on which the qualified plan, is provided within the time limit continuation coverage. (1) Except as beneficiary loses (or would lose) established under the plan in provided in paragraph (b) (2) or (3) of coverage under the plan as a result of conformity with paragraph (c) of this this section, upon receipt of a notice of the qualifying event; or section, and the administrator is able to qualifying event furnished in (iii) The date on which the qualified determine from such notice the plan, accordance with § 2590.606–2 or beneficiary is informed, through the the covered employee and qualified § 2590.606–3, the administrator shall furnishing of the plan’s summary plan beneficiary(ies), the qualifying event or furnish to each qualified beneficiary, description or the notice described in disability, and the date on which the not later than 14 days after receipt of the § 2590.606–1, of both the responsibility qualifying event (if any) occurred. notice of qualifying event, a notice to provide the notice and the plan’s (2) An administrator may require a meeting the requirements of paragraph procedures for providing such notice to notice that does not contain all of the (b)(4) of this section. the administrator. information required by the plan to be (2) In the case of a plan with respect (2) Time limits for notice of disability supplemented with the additional to which an employer of a covered determination. (i) Subject to paragraph information necessary to meet the plan’s employee is also the administrator of (c)(2)(ii) of this section, the period of reasonable content requirements for the plan, except as provided in time for furnishing the notice described such notice in order for the notice to be paragraph (b)(3) of this section, if the in paragraph (a)(4) of this section may deemed to have been provided in employer is otherwise required to not end before the date that is 60 days accordance with this section. furnish a notice of a qualifying event to after the latest of: (e) Who may provide notice. With an administrator pursuant to (A) The date of the disability respect to each of the notice § 2590.606–2, the administrator shall determination by the Social Security requirements of this section, any furnish to each qualified beneficiary a Administration; individual who is either the covered notice meeting the requirements of

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paragraph (b)(4) of this section not later including an explanation that a (xii) A description of the due dates for than 44 days after: qualified beneficiary’s decision whether payments, the qualified beneficiaries’ (i) In the case of a plan that provides, to elect continuation coverage will affect right to pay on a monthly basis, the with respect to the qualifying event, that the future rights of qualified grace periods for payment, the address continuation coverage and the beneficiaries to portability of group to which payments should be sent, and applicable period for providing notice health coverage, guaranteed access to the consequences of delayed payment under section 606(a)(2) of the Act shall individual health coverage, and special and non-payment; commence with the date of loss of enrollment under part 7 of title I of the (xiii) An explanation of the coverage, the date on which a qualified Act, with a reference to where a importance of keeping the administrator beneficiary loses coverage under the qualified beneficiary may obtain informed of the current addresses of all plan due to the qualifying event; or additional information about such participants or beneficiaries under the (ii) In all other cases, the date on rights; and a description of the plan’s plan who are or may become qualified which the qualifying event occurred. procedures for revoking a waiver of the beneficiaries; and (3) In the case of a plan that is a right to continuation coverage before the (xiv) A statement that the notice does multiemployer plan, a notice meeting date by which the election must be not fully describe continuation coverage the requirements of paragraph (b)(4) of made; or other rights under the plan, and that this section shall be furnished not later (vii) A description of the continuation more complete information regarding than the later of: coverage that will be made available such rights is available in the plan’s (i) The end of the time period under the plan, if elected, including the summary plan description or from the provided in paragraph (b)(1) of this date on which such coverage will plan administrator. section; or commence, either by providing a (c) Notice of unavailability of (ii) The end of the time period description of the coverage or by continuation coverage. (1) In the event provided in the terms of the plan for reference to the plan’s summary plan that an administrator receives a notice such purpose. description; furnished in accordance with (4) The notice required by this (viii) An explanation of the maximum § 2590.606–3 relating to a qualifying paragraph (b) shall be written in a period for which continuation coverage event, second qualifying event, or manner calculated to be understood by will be available under the plan, if determination of disability by the Social the average plan participant and shall elected; an explanation of the Security Administration regarding a contain the following information: (i) The name of the plan under which continuation coverage termination date; covered employee, qualified beneficiary, continuation coverage is available; and and an explanation of any events that or other individual and determines that the name, address and telephone might cause continuation coverage to be the individual is not entitled to number of the party responsible under terminated earlier than the end of the continuation coverage under part 6 of the plan for the administration of maximum period; title I of the Act, the administrator shall continuation coverage benefits; (ix) A description of the provide to such individual an (ii) Identification of the qualifying circumstances (if any) under which the explanation as to why the individual is event; maximum period of continuation not entitled to continuation coverage. (iii) Identification, by status or name, coverage may be extended due either to (2) The notice required by this of the qualified beneficiaries who are the occurrence of a second qualifying paragraph (c) shall be written in a recognized by the plan as being entitled event or a determination by the Social manner calculated to be understood by to elect continuation coverage with Security Administration, under title II the average plan participant and shall be respect to the qualifying event, and the or XVI of the Social Security Act (42 furnished by the administrator in date on which coverage under the plan U.S.C. 401 et seq. or 1381 et seq.) (SSA), accordance with the time frame set out will terminate (or has terminated) that the qualified beneficiary is in paragraph (b) of this section that unless continuation coverage is elected; disabled, and the length of any such would apply if the administrator (iv) A statement that each individual extension; received a notice of qualifying event and who is a qualified beneficiary with (x) In the case of a notice that offers determined that the individual was respect to the qualifying event has an continuation coverage with a maximum entitled to continuation coverage. independent right to elect continuation duration of less than 36 months, a (d) Notice of termination of coverage, that a covered employee or a description of the plan’s requirements continuation coverage. (1) The qualified beneficiary who is the spouse regarding the responsibility of qualified administrator of a plan that is providing of the covered employee (or was the beneficiaries to provide notice of a continuation coverage to one or more spouse of the covered employee on the second qualifying event and notice of a qualified beneficiaries with respect to a day before the qualifying event disability determination under the SSA, qualifying event shall provide, in occurred) may elect continuation along with a description of the plan’s accordance with this paragraph (d), coverage on behalf of all other qualified procedures for providing such notices, notice to each such qualified beneficiary beneficiaries with respect to the including the times within which such of any termination of continuation qualifying event, and that a parent or notices must be provided and the coverage that takes effect earlier than legal guardian may elect continuation consequences of failing to provide such the end of the maximum period of coverage on behalf of a minor child; notices. The notice shall also explain continuation coverage applicable to (v) An explanation of the plan’s the responsibility of qualified such qualifying event. procedures for electing continuation beneficiaries to provide notice that a (2) The notice required by this coverage, including an explanation of disabled qualified beneficiary has paragraph (d) shall be written in a the time period during which the subsequently been determined to no manner calculated to be understood by election must be made, and the date by longer be disabled; the average plan participant and shall which the election must be made; (xi) A description of the amount, if contain the following information: (vi) An explanation of the any, that each qualified beneficiary will (i) The reason that continuation consequences of failing to elect or be required to pay for continuation coverage has terminated earlier than the waiving continuation coverage, coverage; end of the maximum period of

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continuation coverage applicable to employee’s spouse resides at the same single-employer group health plans and such qualifying event; location as the covered employee; and must be modified if used to provide (ii) The date of termination of (2) An administrator may provide notice with respect to other types of continuation coverage; and notice to each qualified beneficiary who group health plans, such as (iii) Any rights the qualified is the dependent child of a covered multiemployer plans or plans beneficiary may have under the plan or employee by furnishing a single notice established and maintained by under applicable law to elect an to the covered employee or the covered employee organizations for their alternative group or individual employee’s spouse, if, on the basis of members. In order to use the model coverage, such as a conversion right. the most recent information available to notice, administrators must (3) The notice required by this the plan, the dependent child resides at appropriately add relevant information paragraph (d) shall be furnished by the the same location as the individual to where indicated in the model notice, administrator as soon as practicable whom such notice is provided. select among alternative language and following the administrator’s supplement the model notice to reflect determination that continuation (f) Delivery of notice. The notices required by this section shall be applicable plan provisions. Items of coverage shall terminate. information that are not applicable to a (e) Special notice rules. The notices furnished in any manner consistent particular plan may be deleted. Use of required by paragraphs (b), (c), and (d) with the requirements of § 2520.104b–1 the model notice, appropriately of this section shall be furnished to each of this chapter, including paragraph (c) modified and supplemented, will be qualified beneficiary or individual, of that section relating to the use of deemed to satisfy the notice content except that: electronic media. (1) An administrator may provide (g) Model notice. The appendix to this requirements of paragraph (b)(4) of this notice to a covered employee and the section contains a model notice that is section. covered employee’s spouse by intended to assist administrators in (h) Applicability. This section shall furnishing a single notice addressed to discharging the notice obligations of apply to any notice obligation described both the covered employee and the paragraph (b) of this section. Use of the in this section that arises on or after the covered employee’s spouse, if, on the model notice is not mandatory. The first day of the first plan year beginning basis of the most recent information model notice reflects the requirements on or after November 26, 2004. available to the plan, the covered of this section as they would apply to BILLING CODE 4510–29–P

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Signed at Washington, DC., this 19th day of May, 2004. Ann L. Combs, Assistant Secretary, Employee Benefits Security Administration, Department of Labor. [FR Doc. 04–11796 Filed 5–25–04; 8:45 am] BILLING CODE 4510–29–C

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Part VI

Department of Transportation Research and Special Programs Administration

49 CFR Part 171 Hazardous Materials: Revisions to Incident Reporting Requirements and the Hazardous Materials Incident Report Form; Correction; Final Rule

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DEPARTMENT OF TRANSPORTATION Hazardous Materials Regulations (HMR; rule. The issues raised by the appellants 49 CFR Parts 171–180) and the are discussed in detail below. Research and Special Programs Hazardous Materials Incident Report A. Appeals Granted Administration Form DOT F 5800.1. Specifically, the final rule: Electronic Filing—The December 3 49 CFR Part 171 • Revised the hazardous materials final rule revised § 171.16 (b) to require each person reporting under this section [Docket No. RSPA–99–5013 (HM–229)] incident report form; • Provided for electronic filing of to submit a written or electronic HMIR RIN 2137–AD21 incident reports; to the Information Systems Manager at • Established one-call reporting of the Research and Special Programs Hazardous Materials: Revisions to hazardous materials incidents; Administration. Mr. John Currie stated Incident Reporting Requirements and • Expanded reporting requirements to that as drafted, § 171.16(b)(1) could be the Hazardous Materials Incident persons other than carriers; interpreted to require both the Report Form; Correction • Expanded reporting exceptions; submission of a written and electronic • AGENCY: Research and Special Programs Provided criteria for telephonic HMIR. We agree that the language is Administration (RSPA), DOT. notification; unclear and could lead to unnecessary • Provided criteria for updates to submissions of duplicate reports. ACTION: Final rule; response to appeals incident reports; Therefore, in this final rule, we are and correction. • Required reporting of undeclared adding the word ‘‘or’’ between the SUMMARY: On December 3, 2003, RSPA shipments of hazardous materials; addresses for written and electronic • published a final rule under Docket No. Required reporting of non-release submittal of the HMIR to clarify that incidents involving cargo tanks; either a written or electronic report RSPA–99–5013 (HM–229) to update and • clarify requirements in the Hazardous Provided definitions of must be submitted, not both. Materials Regulations applicable to ‘‘Undeclared Hazardous Material’’ and Revised Hazardous Materials Incident ‘‘Unintentional Release’’; and Form DOT F 5800.1—The December 3 incident reporting requirements and the • Hazardous Materials Incident Report Eliminated redundant or final rule revised the HMIR Form DOT (HMIR) DOT Form F 5800.1. In response unnecessary regulations. In addition, F 5800.1 and instructions. AAR to appeals submitted by persons affected the December 3 final rule revised the requested that RSPA reconsider by the December 3, 2003 final rule, this HMR to address three recommendations eliminating certain required information final rule amends certain requirements, from the National Transportation Safety on the HMIR that AAR considers Board (NTSB): unnecessary and difficult to obtain. and makes minor editorial corrections. • This final rule is effective January 1, Consistent with NTSB AAR notes that, as drafted, the 2005. The effective date for the final Recommendation H–92–6, established a instructions following Item 23 instruct rule published on December 3, 2003 has program to collect information the filer to skip Part III ‘‘Packing been extended from July 1, 2004 to necessary to identify patterns of cargo Information’’ and proceed to Part IV, January 1, 2005. tank equipment failures, including the which AAR believes was not RSPA’s reporting of all accidents involving a intent. However, if Part III is to be DATES: Effective Date: This final rule is DOT specification cargo tank, with or completed, AAR takes issue with two effective on January 1, 2005. The without a release of hazardous points related to Item 28, found in Part effective date for the final rule materials. III. The first point is discussed here; the published on December 3, 2003 has • Consistent with NTSB second point can be found under the been extended from July 1, 2004 to recommendation R–89–52, set forth ‘‘Appeals Denied’’ section of this January 1, 2005. Only the revised DOT procedures being implemented to document. Form F 5800.1 (01–2004) specified in ensure there is feedback to shippers Item 28 requires the identification of this final rule will be accepted for when an incident has occurred. the manufacturer and model number for incidents occurring on or after January • Consistent with NTSB any valve or device that failed on a tank 1, 2005. Filers must use the previous recommendation H–99–58, established a car. AAR stated that this poses a DOT Form F 5800.1 (Rev 6/89) form for specific time period for reporting problem if the specification plates all incidents up to and including incidents meeting criteria in § 171.15 containing this information are missing December 31, 2004. (telephonic notification). or obscured. The builder of the tank car FOR FURTHER INFORMATION CONTACT: T. may not be able to provide this Glenn Foster, (202) 366–8553, Office of II. Appeals information on the HMIR if subsequent Hazardous Materials Standards, The following organizations and one owners or lessees have changed valves. Research and Special Programs individual submitted appeals to the Railroads would be compelled to rely on Administration, or Kevin Coburn, (202) December 3, 2003 final rule, in the efforts of car owners for this 366–4555, Office of Hazardous Materials accordance with 49 CFR Part 106: The information in order to complete the Planning & Analysis, Research and Air Transport Association (ATA-Air); required entry on the incident report Special Programs Administration, U.S. the American Trucking Associations form. This reliance on an outside party Department of Transportation, 400 (ATA-Trucking); the Association of could jeopardize the thirty-day filing Seventh Street, SW., Washington, DC American Railroads (AAR); the National requirement. AAR believes RSPA 20590. Propane Gas Association (NPGA); the should require this information to be SUPPLEMENTARY INFORMATION: National Tank Truck Carriers, Inc. clearly marked on valves and other (NTTC); the Petroleum Transportation & devices at all times, if RSPA determines I. Background Storage Association (PTSA); and Mr. it is necessary. On December 3, 2003, the Research John V. Currie. The appellants We agree with AAR’s comment and Special Programs Administration expressed concern about several regarding reference to the guidance (RSPA, we) published a final rule under revisions included in the final rule. In immediately following Item 23 of the Docket HM–229 (68 FR 67746) revising addition, two appellants asked for a HMIR. As drafted, the instructions omit incident reporting requirements of the revision to the effective date of the final Part III and instruct the filer to proceed

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directly to Part IV for a hazardous electronic filing methods, including filing. We do not agree that an materials incident, or a specification facsimile, electronic mail, and internet- immediate effective date, nor a delay of cargo tank 1,000 gallons or greater based filing options. The appellant the effective date for 12 months containing any hazardous material that states the final rule does not provide for following the publication of guidance received structural damage to the lading electronic filing. Instead, RSPA implementing the electronic filing retention system that requires repair and indicated that it is ‘‘in the process of procedures with a three-month did not have a release. This was not our developing the capability to allow transitional period for the new system, intent. One of our objectives is to electronic submission of the form and is necessary, therefore these appeals are acquire accurate and complete data on bulk transfer, and will issue an advisory denied. However, we are extending the incidents. In this final rule, we are notification upon completion.’’ ATA- effective date until January 1, 2005 to removing the supplemental guidance Trucking explains that, ‘‘*** provide companies with additional time immediately following Item 23 from the depending upon the date electronic for training and familiarization with the HMIR. filing options go live, motor carriers will new HMIR. We reiterate that only the We also agree with AAR’s concern have to train their employees on the revised DOT Form F 5800.1 (01–2004) regarding reporting the manufacturer new form and then subsequently train specified in this final rule will be and model number for any valve or them to implement the electronic filing accepted for incidents occurring on or device that failed on a tank car. In this options.’’ The appellant contends this after January 1, 2005. Filers must use final rule, we are retaining the ‘‘* * * will force industry to incur the previous DOT Form F 5800.1 (Rev requirement to specify the ‘‘type’’ of unnecessary training expenses.’’ ATA- 6/89) form for all incidents up to and valve or device that failed during an Trucking also believes ‘‘there should be including December 31, 2004. incident. However, we are amending the Expansion of Reporting Requirements a period of time (i.e., three months) requirement to provide the to Persons other than Shippers—The following the effective date, where the manufacturer and model number for any December 3 final rule revised the HMR use of the existing HMIR form would valve or device that failed on a tank to to expand the requirement to report result in a formal warning, rather than include the words ‘‘if present and incidents to the person in physical a notice of violation and civil penalty.’’ legible.’’ possession of a hazardous material at The appellant believes a provision by the time an incident occurs during B. Appeals Denied RSPA ‘‘* * * would help companies transportation. Effective Date of the Final Rule—The with multiple facilities train each ATA-Trucking states that RSPA is December 3, 2003 final rule established potentially affected person,’’ thus ‘‘* * * handcuffed by the jurisdictional the effective date of this rule as July 1, avoiding situations of non-compliance. decisions made in connection with the 2004. ATA-Air and ATA-Trucking The appellant notes that because most HM–223 rulemaking’’ and ‘‘* * * has request RSPA to reconsider the July 1, companies have already approved excluded unloading activities performed 2004 effective date. ATA-Air requests technical and informational projects for by non-carrier personnel from the scope that RSPA allow carriers to begin 2004 and finalized their 2004 capital of the hazardous materials incident complying with the new rules (other budgets, it will be difficult to implement reporting requirements.’’ The appellant than those applicable to discoveries of an informational change before the 2005 asserts that ‘‘* * * RSPA’s decision to undeclared hazardous materials) earlier budget year. RSPA does not agree that exclude activities performed by the than July 1, 2004. ATA-Air notes that we have not addressed electronic filing consignee will reduce the quantity of many companies have pre-established methods. We fully anticipate an hazardous materials incident reports by training schedules and could begin their operational electronic system by the RSPA.’’ In addition, it states that ‘‘*** employees on the new requirements effective date of the final rule, which, as the quality of the information RSPA immediately. In addition, rather than previously stated, is the earliest date the receives will be impacted, as the data expecting employees to retain the new revised form will be accepted. RSPA will be over-weighted with packaging incident reporting information for also recognizes that filers of the revised failures that occur during accidents, several months, the Association incident report may benefit from a while the number of reports received contends it would be beneficial to apply tutorial phase for training purposes and from packaging failures that occur under the training immediately. The appellant orientation, and anticipates an normal conditions of transportation and sees no potential concern if the carriers interactive incident report form on our are only discovered during the begin following the revised Web site prior to the effective date. This unloading process will be artificially requirements earlier than currently development will provide accessibility under-weighted.’’ RSPA’s ‘‘*** required. by filers and downloading capabilities decision to exempt consignees from the ATA-Trucking recommends that of the revised form. In addition, RSPA requirement to complete incident RSPA delay the effective date for 12 is making available a dedicated reports undermines the fundamental months following the publication of facsimile phone line to facilitate this purpose of the Hazardous Materials guidance implementing the electronic alternate reporting option. We are Incident Reporting system, which is to filing procedures and provide a three- reconfiguring our computer software collect meaningful data on the month transitional period for the new programs to accept electronic performance of DOT packaging system. The appellant states industry submissions via the Web site, and standards under conditions normally bears significant costs, including the providing an electronic version of the incidental to transportation.’’ ATA- revision of internal computer software form that can be completed, printed, Trucking recommends RSPA reconsider and employee training, whenever an and mailed or faxed to RSPA. Finally, this aspect of the final rule and expand information requirement is revised. The a bulk transfer system is being the hazardous materials incident appellant asserts the July 1, 2004 developed to allow for batch reporting obligation to individuals effective date would not provide transmittals of multiple incident responsible for the unloading of industry adequate time to train its reports. We reiterate that an advisory hazardous materials. employees. In addition, this appellant notification will be issued upon We disagree. The reporting notes the HM–229 NPRM called for the completion and availability of these requirements found in §§ 171.15 and implementation of a variety of alternate methods of incident report 171.16 pertain to incidents that occur

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during transportation, including storage of the lading retention system. In a from the uncertainty of whether to file incidental to transportation. The issues second example, NTTC describes a an incident report’’ * * * ATA- posed by the appellant concern whether carrier driver relinquishing control of Trucking recommends RSPA eliminate incidents involving pre-transportation the cargo tank to a shipper before the the tank truck operator’s obligation to functions are reportable under §§ 171.15 unit is staged for loading. Damage that file a hazardous materials report when and 171.16. While pre-transportation may result from these activities might no hazardous material has been released functions, such as shipper loading not be discovered for a considerable or in the alternative, amend operations when a carrier is not present, amount of time. NTTC does not believe § 171.16(a)(3) to reference § 180.407(b) are regulated under the HMR, they have RSPA addressed these concerns in the as suggested by NTTC. not been and are not subject to the final rule and reiterates them in its NPGA also ‘‘* * * opposes the last incident reporting requirements under appeal to this rulemaking. NTTC portion of this provision and believes this rulemaking because incidents believes RSPA has unfairly and the collection of this incident related to pre-transportation functions unwisely placed tank truck carriers in a information will not provide the type of occur prior to the beginning of ‘‘compliance trap’’ and wonders if tank data sought by RSPA that would result transportation in commerce. Therefore, truck operators will have to perform ‘‘ in increased safety.’’ NPGA believes this the status of reporting these pre- * * * detailed internal and external provision is ‘‘* * * vague, fails to transportation functions has not been inspections of all lading retention provide the regulated parties the changed by either the HM–229 or HM– systems after each ‘near-miss’?’’ NTTC requisite certainty to enable compliance, 223 (68 FR 61905) final rules. Regarding states RSPA justified this requirement and will lead to inconsistent our decision to exempt consignees from by relying on a decade-old report by the enforcement in the field.’’ NPGA incident reporting, we point out that NTSB (PB92–917220) and questions the reminds RSPA of its comments during consignees have never been subject to relevancy of that report and the rulemaking stage noting the genesis incident reporting (except for recommendations. NTTC states the of HM–229 was the HM–225A consignees unloading rail cars in NTSB report contains only data of so- negotiated rulemaking between the accordance with § 174.67). The called ‘‘rollover’’ accidents involving cargo tank industry and DOT. NPGA clarifications in HM–223 are consistent cargo tank motor vehicles; all of the argues that more data is not better data. with our long-standing interpretations incidents in the report involved releases NPGA notes RSPA’s HM–229 preamble of our statutory authority. In addition, of hazardous materials in the discussion ‘‘* * * that such reporting we note that carrier reports, including environment and pertained to can provide information concerning reports by carriers involved in measurable specification shortages on packaging integrity.’’ This final rule unloading hazardous materials at vehicles that have previously been expands the incident database ‘‘*** consignee facilities, are and have been addressed by RSPA and the Federal to include ‘‘near miss’’ or ‘‘close call’’ sufficient to enable us to receive Motor Carrier Safety Administration incidents, which ‘‘* * * have the accurate information about packaging (FMCSA). NTTC states that if RSPA potential for significant consequences.’’ failures that occur during normal truly believes ‘‘accurate (‘near miss’ or NPGA believes the vagueness of this transportation operations. For these ‘close call’) data will prevent safety regulation creates uncertainty as to reasons, the ATA-Trucking’s appeal gaps,’’ as well as determine ‘‘*** when a report should be filed. ‘‘*** concerning the expansion of reporting how to allocate limited funds of the Multiple instances of less serious damage could lead to a form of damage requirements to the person in physical regulated community to provide the considered more serious, thus possession of a hazardous material at greatest safety benefits, RSPA would be necessitating a report filing.’’ NPGA the time an incident occurs in remiss in not extending such reporting recommends RSPA delete the phrase ‘‘ transportation is denied. to all specification packagings.’’ As an Reporting Non-Release Incidents * * * even if there is no release of alternative, NTTC suggests the following Involving Cargo Tanks—The December hazardous material’’ from § 171.16(a)(3), modification: ‘‘A specification cargo 3 final rule requires an HMIR be and modify the provision to reference tank with a capacity of 1,000 gallons or submitted when a specification cargo § 180.407(b) as suggested by NTTC. greater containing any hazardous tank with a capacity of 1,000 gallons or NPGA contends this section ‘‘*** is material is damaged to the extent that it greater containing any hazardous much more familiar to the industry and becomes subject to 49 CFR material suffers structural damage to the provides a form of criteria for filing lading retention system or damage that § 180.407(b).’’ reports that the currently adopted requires repair to a system intended to ATA-Trucking states that in addition provision lacks.’’ protect the lading retention system, to ‘‘* * * artificially limiting the PTSA states this provision is vague, even if there is no release of hazardous number of reports received from will lead to uneven compliance and material. NTTC, ATA-Trucking, NPGA, incidents discovered during unloading, inconsistent enforcement, and places a and PTSA appealed this provision on RSPA has expanded the number of greater and unwarranted compliance the basis that it: (1) Is vague; (2) removes reports it will collect by expanding the burden on small business petroleum the certainty of whether to file an incident reporting requirement to bulk marketers. According to PTSA, ‘‘*** incident report; (3) could not be cargo tanks that suffer certain damage petroleum marketers are likely to incur enforced in an equitable manner; and (4) that does not result in a release of undeserved civil penalties and places carriers in a compliance trap. The hazardous materials.’’ ATA-Trucking unjustified safety rating scores * * *’’ appellants recommend the provision believes this ‘‘standard for reporting PTSA states that the ability for small either be deleted or modified to include damage in the absence of a release is business petroleum marketers to obtain a statement referencing damage vague and will potentially lead to certainty of compliance is vital to requiring test and inspection of cargo instances of non-compliance.’’ ATA- ensure the safe transportation of tanks as set forth in § 180.407(b). Trucking supports the proposal crafted hazardous materials and maintain a NTTC contends a product could be by NTTC. ATA-Trucking believes competitive edge against larger loaded into a cargo tank that was not NTTC’s proposal ‘‘* * * would create hazardous materials carriers with more designed for or otherwise suitable for objective reporting criteria and reduce compliance resources. PTSA believes the product, resulting in a compromise instances of non-compliance resulting the information collected from non-

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release incidents is subjective and incidents involving cargo tanks are of the HMR for discrepancy reporting by disagrees with RSPA’s belief that denied. carriers. For these reasons, ATA-Air’s information collected can provide Reporting Undeclared Shipments of appeal concerning the reporting of valuable data on packaging integrity. Hazardous Materials—The December 3 undeclared shipments of hazardous PTSA argues the terms ‘‘near miss’’ or final rule revised § 171.16 to require a materials is denied. ‘‘close call’’ in the preamble are too person who discovers an undeclared Requirements To Update the Incident ambiguous to provide any degree of hazardous material to submit an HMIR. Report—The December 3 final rule certainty. PTSA believes that ‘‘*** ATA-Air requests reconsideration of the amended the HMR to require that an only engineering studies, under new requirement ‘‘* * * in light of the HMIR must be updated within one year controlled conditions and involving current airport security environment, of the date of occurrence of the incident expert analysis can provide the which did not exist during the comment whenever one or more of the following objective information regarding period * * *’’ of the final rule. This occur: (1) A death results from injury packaging integrity that RSPA seeks to appellant notes the Transportation caused by a hazardous material; (2) collect.’’ PTSA recommends RSPA Security Administration (TSA) inspects there was a misidentification of the eliminate the requirement for reporting checked baggage, resulting in a dramatic hazardous material or package under § 171.16(a)(3) involving incidents increase in the volume of such information on a prior incident report; where no release occurs. If RSPA discoveries, and ‘‘* * * the consumer- (3) damage, loss or related cost that was chooses not to follow this goods nature of most items found merits not known when the initial incident recommendation, PTSA contends that a consideration.’’ ATA-Air states that the report was filed becomes known; or (4) less desirable, but more acceptable revised four-page HMIR is an damage, loss, or related cost changes by alternative would be to amend unnecessary burden and duplicates $25,000 or more, or 10% of the prior § 171.16(a)(3) to reference § 180.407(b) carriers’ existing discrepancy reporting total estimate, whichever is greater. as suggested by NTTC. obligations for the same items under 49 ATA-Trucking requests that with the CFR § 175.31.’’ ATA-Air also stated that exception of an incident that results in RSPA disagrees with the appellants. RSPA is required by the Paperwork a death subsequent to the filing of the We believe the revisions in this final Reduction Act (PRA) ‘‘* * * to avoid report, RSPA reconsider the obligation rule encompass and exceed the such complication and duplication, to update the incident report. The conditions in § 180.407(b) by requiring particularly in view of carriers’ dire appellant states that although the a more detailed accounting of incidents financial circumstances and sharply preamble ‘‘* * * references comments involving hazardous materials, reduced staffing * * *’’ in the wake of filed by industry indicating a substantial providing specific failure codes, September 11, 2001. The appellant burden associated with this aspect of expanding the reporting requirements to disputes that the average number of the final rule, RSPA has done little more persons other than carriers, and defining incident reports from 1997–2000 is than quote from these comments.’’ ATA- an ‘‘undeclared hazardous material’’ representative of current experience. Trucking also stated ‘‘RSPA performed and ‘‘unintentional release.’’ We The appellant stated that RSPA’s no analysis of the burden associated rationalize that ‘‘structural damage’’ is analysis cited under the PRA section in with this requirement or the benefit of any damage that causes a person to ask the final rule preamble ‘‘* * * should the update requirement (i.e., the number the question implied in be updated to take into account the of updates that would result in a § 180.407(b)(2)—was the cargo tank greatly increased volume of discoveries material impact upon RSPA’s analyses). damaged to an extent that its lading stemming from TSA screening.’’ ATA- Instead, RSPA justified the update retention capability may be affected? If Air suggests RSPA defer requirement with * * *’’ two sentences. the damage is sufficient to trigger the implementation of this aspect of the rule ATA-Trucking asserts that ‘‘RSPA has a repair of the cargo tank, an HMIR until these issues are resolved. ATA-Air legal obligation to analyze the issue and should be filed. Consequently, if the recommends RSPA ‘‘* * * convene an discuss its conclusion in the final rule,’’ question is answered affirmatively, advisory committee to bring together all and that RSPA ‘‘* * * failed to respond testing and inspection are also required. stakeholders, including RSPA, Federal meaningfully to these comments.’’ ATA- While RSPA recognizes that some Aviation Administration (FAA), ATA- Trucking recommends RSPA reconsider judgment may still be involved, we do Air, and the carriers, to develop a this requirement of the final rule by not foresee this causing a significant workable solution to these issues.’’ narrowing the scope of updating number of new reports being generated. ATA-Air urges RSPA to ‘‘* * * re-open requirements to instances where a death In addition, such reporting will provide the comment period for this aspect of occurs subsequent to the filing of an us with a better idea of the number of the final rule, and revise the rule in HMIR. cargo tanks involved in accidents with accordance with those supplemental We disagree. RSPA believes the at least some damage to the lading comments.’’ criteria outlined in the December 3 final retention or lading protection system. RSPA agrees with the appellant that rule to update an incident report are As noted in the December 3 final rule, the potential for the discoveries of essential in monitoring the results of information gathered on damage to undeclared shipments has greatly hazardous materials incidents. By certified cargo tanks of 1,000 gallons or increased due to heightened awareness establishing a requirement to report more that do not result in a release will of airport security following the tragic subsequent developments of hazardous be analyzed over the next several years September 11, 2001 attacks. However, in materials incidents, RSPA is better to determine its usefulness in practice § 171.16(d)(3) of the December 3 final equipped to increase the accuracy of the and if further rulemaking is necessary. rule, we provided an exception from incident reporting database, highlight As also noted in the December 3 final reporting hazardous material discovered packaging shortcomings, and identify rule, RSPA may address requiring in an air passenger’s checked or carry- deficiencies in the handling and additional information for other bulk on baggage during the airport screening transportation of hazardous materials. In packagings in a future rulemaking. For process. In addition, we acknowledge addition, we believe the factors these reasons, the appeals of NTTC, the potential for burdensome and necessary to warrant an additional ATA-Trucking, NPGA, and PTSA duplicative discrepancy reporting update are severe enough to demand regarding the reporting of non-release obligations and refer the filer to § 175.31 their addition to the incident report

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database. For example, a carrier responses by emergency personnel. This requirements are warranted. Therefore, involved in an incident involving black cross-reference information provides AAR’s petition to omit the requirement powder reported damages of $120,000, RSPA with an enhanced capability to to report material of construction, however, subsequent evaluation by the identify the effectiveness of existing design pressure, shell thickness, and Federal Highway Administration regulations and industry operational head thickness in Item 28 is denied. (FHWA) estimated costs of $25 million procedures, focus on potential problems in terms of impacts due to traffic delays. areas such as training and the handling C. Clarification We believe that better determinations of and transportation of hazardous A concerned industry member overall costs by carriers when filing the materials, improve analysis of suggested that the definition of an initial HMIR will minimize the need for hazardous materials incidents, and ‘‘undeclared hazardous material’’ as subsequent updated reports. We extend outreach to shippers of incidents revised in the December 3 final rule disagree that an analysis of the burden involving materials they have offered for could be interpreted to exclude a associated with this requirement or the transportation. In addition, RSPA shipment described as ‘‘freight all benefit of the update requirement was believes registration numbers can be kinds.’’ This is not our intention. A key not performed. As previously stated in acquired from the shipper/offeror objective of this final rule is to focus on the December 3 final rule, we estimate during the standard notification defining and identifying undeclared approximately 800 incidents reported between shippers and carriers that hazardous material shipments. each year would require an update at a would normally follow in the aftermath Undeclared shipments are a high cost on average of $6.00 per company, of a hazardous materials incident. priority and concern within the or $4,800.00. An analysis of the Likewise, a fire, police, or emergency Department, especially in light of the associated costs to update the responder report number can be increased safety environment that has approximately 800 incident reports can obtained by the person in physical become prevalent following the be found in the regulatory evaluation as possession of the shipment from the September 11, 2001 attacks. Our intent referenced under ‘‘Executive Order responder at the time of an incident. For 12866 and DOT Regulatory Policies and these reasons, AAR’s petitions regarding in this rule is to discover undeclared Procedure’’ of the ‘‘Regulatory Analyses Items 11 and 31 are denied. hazardous material shipments that have and Notices’’ section of the December 3 AAR notes that, as drafted, the been buried or hidden in order to final rule, as well as the ‘‘Potential Cost instructions following Item 23 instruct prevent damage to property, loss of life, Impacts’’ heading found under the the filer to skip Part III ‘‘Packing or lack of communication to emergency ‘‘Regulatory Flexibility Act’’ of the Information’’ and proceed to Part IV. responders. In that regard, we are December 3 final rule. For these reasons, The appellant does not believe this was amending the definition of ‘‘undeclared ATA-Trucking’s appeal is denied. RSPA’s intention. We agree, and address shipments’’ in § 171.8 to assist in further Revised Hazardous Materials Incident this issue under the ‘‘Appeals Granted’’ clarifying the regulations as follows: Form DOT F 5800.1—The December 3 section of this document. AAR further Undeclared hazardous material means a final rule revised the HMIR and states that if Part III is to be completed, hazardous material that is: (1) Subject to instructions. AAR requests that RSPA it takes issue with two aspects of Item any of the hazard communication reconsider certain required information 28, found in Part III of the form. The requirements in subparts C (Shipping on the HMIR that AAR considers first point regarding reporting the Papers), D (Marking), E (Labeling), and unnecessary and difficult to obtain. The manufacturer and model number for any F (Placarding) of Part 172 of this appellant asserts the shipper/offeror’s valve that failed on a tank car can be subchapter, or an alternative marking hazardous materials registration number found under the ‘‘Appeals Granted’’ requirement in Part 173 of this required by Item 11 of the form is not section of this document. The second subchapter (such as §§ 173.4(a)(10) and readily available to carriers. The point is discussed here. Item 28 requires 173.6(c)); and (2) offered for appellant believes that ‘‘* * * railroads a filer to indicate material of transportation in commerce without any will have difficulty acquiring the construction, design pressure, shell visible indication to the person shipper’s registration number within the thickness, and head thickness as part of accepting the hazardous material for thirty (30) day filing limit specified in the packing construction and test transportation that a hazardous material § 171.16(a),’’ therefore, registration information. AAR contends the tank car is present, on either an accompanying numbers should be required on specification is previously required to shipping document, or the outside of a shipping papers if their inclusion is be supplied for Item 26a; thus negating transport vehicle, freight container, or viewed as necessary by RSPA. In the need to provide the construction package. addition, the appellant is concerned that information requirement of Item 28. III. Regulatory Analyses and Notices report numbers for reports filed by fire, We do not agree with AAR’s appeal police, and emergency responders regarding the request for material of A. Executive Order 12866 and DOT required by Item 31 of the form are not construction, design pressure, shell Regulatory Policies and Procedures readily available, and it does not thickness, and head thickness required perceive a need by RSPA for this by Item 28 of the incident report. While This final rule is not a significant information. The appellant contends Item 26a requires the identification action under section 3(f) of Executive this lack of easily accessible information markings of packagings, only the Order 12866 and was not reviewed by presents another opportunity to exceed specification requirements can be the Office of Management and Budget. the thirty (30) day filing limit. obtained, not the actual pressure or This final rule is not a significant action We disagree that the inclusion of the thickness of an individual tank car. under the Regulatory Policies and registration number of a shipper/offeror RSPA has determined that this Procedures of the Department of as required in Item 11, and an information is necessary to gauge the Transportation. The revisions adopted emergency responder’s report number as effectiveness of packagings in the event in this final rule do not alter the cost- required in Item 31 are unnecessary. of an incident, and can utilize this benefit analysis and conclusions This information is vital to constructing feedback to determine if future contained in the Regulatory Evaluation a thorough and comprehensive database rulemakings pertaining to packaging prepared for the December 3, 2003 final of incident reports and subsequent specifications and minimal rule. The Regulatory Evaluation is

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available for review in the public docket C. Executive Order 13175 Unfunded Mandates Reform Act of for this rulemaking. This final rule has been analyzed in 1995. It does not result in costs of more than $100 million or more to state, local, B. Executive Order 13132 accordance with the principles and criteria contained in Executive order or tribal governments, in the aggregate, This final rule has been analyzed in 13175 (‘‘Consultation and Coordination or to the private sector, and is the least accordance with the principles and with Indian Tribal Governments’’). burdensome alternative that achieves criteria contained in Executive Order Because this final rule does not have the objective of the rule. 13132 (‘‘Federalism’’). This final rule tribal implications, does not impose H. Environmental Assessment preempts state, local, and Indian tribe substantial direct compliance costs on This final rule does not affect requirements, but does not propose any Indian tribal governments, and does not packaging or hazard communication regulation that has substantial direct preempt tribal law, the funding and requirements for shipments of effects on the states, the relationship consultation requirements of Executive hazardous materials transported in between the national government and Order 13175 do not apply and a tribal commerce. We find that there are no the states, or the distribution of power summary impact statement is not significant environmental impacts and responsibilities among the various required. levels of government. Therefore, the associated with this final rule. D. Regulatory Flexibility Act, Executive consultation and funding requirements List of Subjects in 49 CFR Part 171 of Executive Order 13132 do not apply. Order 13272, and DOT Procedures and Exports, Hazardous materials The Federal hazardous materials Policies transportation, Hazardous waste, transportation law, 49 U.S.C. 5101– The Regulatory Flexibility Act (5 Imports, Reporting and record keeping 5127, contains an express preemption U.S.C. 601–612) requires each agency to requirements. provision (49 U.S.C. 5125(b)) that analyze proposed regulations and assess I preempts state, local, and Indian tribe their impact on small businesses and In consideration of the foregoing, we requirements on certain covered other small entities to determine are making the following corrections to subjects. Covered subjects are: whether the proposed rule is expected FR Doc. 03–29597, appearing on page 67746 in the Federal Register of (1) The designation, description, and to have a significant impact on a Wednesday, December 3, 2003: classification of hazardous materials; substantial number of small entities. (2) The packing, repacking, handling, The revisions adopted in this final rule PART 171—[CORRECTED] labeling, marking, and placarding of do not alter the cost-benefit analysis and hazardous materials; conclusions contained in the Regulatory I 1. On page 67758, in the third column (3) The preparation, execution, and Evaluation prepared for the December 3, and continuing on page 67759, correct use of shipping documents related to 2003 final rule. Based on the assessment the definition for ‘‘undeclared hazardous hazardous materials and requirements in the regulatory evaluation, I certify material’’ to read as follows: that, while this final rule applies to a related to the number, contents, and § 171.8 Definitions and abbreviations. placement of those documents; substantial number of small entities, the economic impact on those small entities * * * * * (4) The written notification, Undeclared hazardous material recording, and reporting of the is not significant. This final rule has been developed in means a hazardous material that is: (1) unintentional release in transportation Subject to any of the hazard of hazardous material; or accordance with Executive Order 13272 (‘‘Proper Consideration of Small Entities communication requirements in (5) The design, manufacture, subparts C (Shipping Papers), D fabrication, marking, maintenance, in Agency Rulemaking’’) and DOT’s procedures and policies to promote (Marking), E (Labeling), and F recondition, repair, or testing of a (Placarding) of Part 172 of this packaging or container represented, compliance with the Regulatory Flexibility Act to ensure that potential subchapter, or an alternative marking marked, certified, or sold as qualified requirement in Part 173 of this for use in transporting hazardous impacts of final rules on small entities are properly considered. subchapter (such as §§ 173.4(a)(10) and material. 173.6(c)); and (2) offered for This final rule addresses covered E. Paperwork Reduction Act transportation in commerce without any subject item number (4) above and This revisions adopted in this final visible indication to the person preempts state, local, and Indian tribe rule do not alter the cost-benefit accepting the hazardous material for requirements not meeting the analysis and conclusions contained in transportation that a hazardous material ‘‘substantively the same’’ standard. This the regulatory evaluation prepared for is present, on either an accompanying final rule is necessary to increase the the December 3, 2003 final rule. shipping document, or the outside of a usefulness of data collected for risk transport vehicle, freight container, or analysis and management by F. Regulation Identifier Number (RIN) package. government and industry and, where A regulation identifier number (RIN) * * * * * possible, provide relief from regulatory is assigned to each regulatory action I 2. On page 67759, in the third column, requirements. listed in the Unified Agenda of Federal Federal hazardous materials correct paragraph (b)(1) of § 171.16 to Regulations. The Regulatory Information read as follows: transportation law provides at Service Center publishes the Unified § 5125(b)(2) that, if we issue a regulation Agenda in April and October of each § 171.16 Detailed hazardous materials concerning any of the covered subjects, year. The RIN number contained in the incidents reports. DOT must determine and publish in the heading of this document can be used * * * * * Federal Register the effective date of to cross-reference this action with the (1) * * * Federal preemption. The effective date Unified Agenda. (b) Providing and retaining copies of may not be earlier than the 90th day the report. Each person reporting under following the date of issuance of the G. Unfunded Mandates Reform Act this section must— final rule and not later than two years This final rule does not impose (1) Submit a written Hazardous after the date of issuance. unfunded mandates under the Materials Incident Report to the

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Information Systems Manager, DHM–63, Administration, Department of Issued in Washington, DC, on May 14, Research and Special Programs Transportation, Washington, DC 20590– 2004, under the authority delegated in 49 Administration, Department of 0001 at http://hazmat.dot.gov; CFR Part 1. Transportation, Washington, DC 20590– * * * * * Samuel G. Bonasso, 0001, or an electronic Hazardous I 3. Beginning on page 67761, correct Deputy Administrator, Research and Special Material Incident Report to the Attachment 1—Hazardous Materials Programs Administration. Information System Manager, DHM–63, Incident Report, to read as set forth BILLING CODE 4910–60–P Research and Special Programs below.

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Attachment 1—Hazardous Materials Incident Report

Note: This attachment will not appear in the Code of Federal Regulations.

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BILLING CODE 4910–60–C

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General Overview for Completing the hazardous materials are loaded with no Hazardous waste—any material that is Hazardous Materials Incident Report— intermediate form of containment and which subject to the Hazardous Waste Manifest Department of Transportation Form F 5800.1 has: Requirements of the U.S. Environmental (1) A maximum capacity greater than 450 Protection Agency specified in 40 CFR Part What Federal Regulation Requires Me To liters (119 gallons) as a receptacle for a 262. Submit the Report? liquid; Marine pollutant—a material that is listed The Hazardous Materials Regulations (2) A maximum net mass greater than 400 in Appendix B to § 172.101 (also see § 171.4) (HMR; 49 CFR Parts 171–180) require that kilograms (822 pounds) and a maximum and, when in a solution or mixture of one or certain types of incidents be reported to the capacity greater than 450 liters (119 gallons) more marine pollutants, is packaged in a Research and Special Programs as a receptacle for a solid; or concentration that equals or exceeds: Administration (RSPA). Section 171.15 of the (3) A water capacity greater than 454 (1) Ten percent by weight of the solution HMR requires an immediate telephonic kilograms (1000 pounds) as a receptacle for or mixture for materials listed in Appendix report (within 12 hours) of certain types of a gas as defined in § 173.115. B; or hazardous materials incidents and a follow- Cargo tank—a bulk packaging which is: (2) One percent by weight of the solution up written report. Section 171.16 requires a (1) A tank intended primarily for the or mixture for materials that are identified as written report for certain types of hazardous carriage of liquids or gases and includes severe marine pollutants in Appendix B. materials incidents within 30 days. Each type appurtenances, reinforcements, fittings, and Undeclared hazardous material—means a of report is explained below. (The full text of closures; hazardous material that is: these sections is at the end of the (2) Is permanently attached to or forms a (1) Subject to any of the hazard instructions.) part of a motor vehicle, or is not permanently communication requirements in subparts C attached to a motor vehicle but which, by What Is the Purpose of the Report? (Shipping Papers), D (Marking), E (Labeling), reason of its size, construction, or attachment and F (Placarding) of Part 172 of this The information you are providing in this to a motor vehicle, is loaded or unloaded subchapter, or an alternative marking report is fundamental to hazardous material without being removed from the motor requirement in Part 173 of this subchapter transportation risk analysis and risk vehicle; and (such as §§ 173.4(a)(10) and 173.6(c)); and management by government and industry. It (3) Is not fabricated under a specification (2) Offered for transportation in commerce allows us to better understand the causes and for cylinders, portable tanks, tank cars, or without any visible indication to the person consequences of hazardous material multi-unit tank car tanks. accepting the hazardous material for transportation incidents. The data is used to Hazardous material—a substance or transportation that a hazardous material is material that has been determined to be identify trends and provide basic program present, on either an accompanying shipping capable of posing an unreasonable risk to performance measures. It helps to document, or the outside of a transport health, safety, and property when transported demonstrate the effectiveness of existing vehicle, freight container, or package. in commerce, and that has been so regulations and to identify areas where Unintentional release—the escape of a designated. The term includes hazardous changes should be considered. It also assists hazardous material from a package on an all parties, including industry segments and substances, hazardous wastes, marine occasion not anticipated or planned. This individual companies, in understanding the pollutants, elevated temperature materials, includes releases resulting from collision, types and frequencies of incidents, what can materials designated as hazardous under the package failures, human error, criminal go wrong, and possible measures that would provisions of § 172.101, the Hazardous activity, negligence, improper packing, or prevent their recurrence. Your accurate and Materials Table (HMT), and materials that unusual conditions such as the operation of complete description of incidents can make meet the defining criteria for hazard classes pressure relief devices as a result of over- a significant contribution to continual safety and divisions in Part 173. pressurization, overfill, or fire exposure. It improvement through better regulations, Hazardous substance—a material, does not include releases, such as venting of cooperative partnerships, and individual including its mixtures and solutions, that— packages, where allowed, and the operational efforts. (1) Is listed in Appendix A to § 172.101; (2) Is in a quantity, in one package, which discharge of contents from packages. Who Must Complete the Report? equals or exceeds the reportable quantity Additionally, for purposes of reporting on Any person in possession of a hazardous (RQ) listed in Appendix A to § 172.101; and this form, the following definitions should be material during transportation, including (3) When in a mixture or solution— used: loading, unloading and storage incidental to (i) For radionuclides, conforms to Lading retention system—a lading transportation, must report to the Department paragraph 7 of Appendix A to § 172.101. retention system consists of those items or of Transportation (DOT) if certain conditions (ii) For other than radionuclides, is in a equipment that provide containment of are met. This means that when the conditions concentration by weight which equals or hazardous materials at some point during apply for completing the report, the entity exceeds the concentration corresponding to transportation, including loading and having physical control of the shipment is the RQ of the material, as shown in the unloading. The cargo tank shell, associated responsible for filling out and filing Form following table: piping, and valves are an example of a lading DOT F 5800.1. retention system. Dents or damage to a tank For example, if a shipper is carrying Concentration by requiring repair to an accident protection hazardous material, the consignee is RQ pounds weight system guarding the tank are examples of unloading the material and there is an (kilograms) incidents that must be reported. Paint chips incident involving this material, the Percent PPM and scratches to either the tank or the consignee is responsible for filling out and accident protection system are examples of filing the form. However, if the consignee is 5000 (2270) ...... 10 100,000 incidents that do not require reporting. unloading the hazardous material and causes 1000 (454) ...... 2 20,000 Major transportation artery—a highway, a hazardous materials incident involving a 100 (45.4) ...... 0.2 2,000 main road or secondary road but not a side consignment intended for someone else, the 10 (4.54) ...... 0.02 200 street or dirt road. In the case of rail, any rail shipper is responsible for filling out and 1 (0.454) ...... 0.002 20 line except a rail spur. filing the form. The term hazardous substance does not When Must I Submit a Written Report (DOT What Definitions Should I Know in Order To include petroleum, including crude oil or Form F 5800.1)? Complete the Report? any fraction thereof which is not otherwise Under § 171.16, you must submit a written In order to accurately complete the report, specifically listed or designated as a report within 30 days after any of the you should be familiar with the following hazardous substance in Appendix A to following: terms. A complete list of definitions is § 172.101, and the term does not include • An incident that was reported by contained in § 171.8. natural gas, natural gas liquids, liquefied telephonic notice under § 171.15; Bulk packaging—a packaging, other than a natural gas, or synthetic gas useable for fuel • An unintentional release (see vessel or a barge, including a transport (or mixtures of natural gas and such synthetic definitions) of a hazardous material during vehicle or freight container, in which gas). transportation including loading, unloading

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and temporary storage related to • A specification cargo tank 1,000 gallons protect the lading retention system, and (2) transportation; or greater containing any hazardous materials did not have a release. • A hazardous waste is released; that (1) received structural damage to the To clarify the requirement for a report • An undeclared shipment with no release lading retention system or damage that based on structural damage to a specification is discovered; or requires repair to a system intended to cargo tank, the table below illustrates some examples:

EXAMPLES TO CLARIFY WHEN TO REPORT STRUCTURAL DAMAGE TO A SPECIFICATION CARGO TANK

Incident report required No incident report required

Damage to an outlet valve that affects seating and requires replace- Handle broken or knocked off valve—but otherwise undamaged. ment. Serious damage that, if worse, could have resulted in the loss of the Serious damage that, even if worse, would not have resulted in the contents of the cargo tank. Damage to outlet lines that contain haz- loss of the contents of the cargo tank. Damage to outlet lines that ardous materials during transportation is in this category. are normally not charged during transportation is in this category. Cargo tank damage that requires professional inspection or recertifi- Minor damage that obviously will not affect continuation of the cargo cation to ensure it is capable of meeting requirements. tank in service. Cargo tank damage that requires immediate or subsequent repair be- Cargo tank damage that requires repair for cosmetic reasons only. cause of questions about cargo tank integrity.

When Is a Report Not Required? • Fire, breakage, spillage or suspected additional information after the initial report. You are not required to report a release of radioactive contamination occurs involving a You are required to provide updates for up a hazardous material if ALL of the following radioactive material; to one year after the initial filing if more • apply: Fire, breakage, spillage or suspected information is gained or new developments • The shipment is not being offered for contamination occurs involving an infectious arise concerning the following, for example: • transportation or being transported by air; substance other than a diagnostic specimen A death results from injuries caused by • None of the criteria in § 171.15(a) or regulated medical waste; a hazardous material; • • applies; There is a release of a marine pollutant The person responsible for preparing the • The material is not a hazardous waste; in a quantity exceeding 450 liters (119) original report learns that there is a • The material is properly classed as an gallons) for liquids or 400 kilograms (882 misidentification of hazardous material or ORM D, or a Packing Group III material in pounds) for solids; or package information; Class or Division 3, 4, 5, 6.1, 8, or 9; • A situation exists of such a nature that • Damage or loss or related costs that were • Each package has a capacity of less than in the judgment of the person in possession not known at the time the report was filed 20 liters (5.2 gallons) for liquids or less than of the hazardous material, it should be become known; or 30 kg (66 pounds) for solids; reported to DOT’s National Response Center • Revised estimates of damages, losses, • The total aggregate release is less than 20 even though it does not meet the above and related costs result in a change of liters (5.2 gallons) for liquids or less than 30 criteria. $25,000 or more, or 10% of the original cost kg (66 pounds) for solids; You may decide that the situation should estimates, whichever is greater, even if the • The material does not meet the be reported even though it does not meet any original estimate was under $500. of the above criteria. definition of an undeclared hazardous How and Where Do I Submit My Completed material in § 171.8; AND Make sure that you request the NRC report Report? • The shipment is an undeclared material number when you make your telephonic discovered in an air passenger’s checked or report. • You can mail paper copies of the report carry-on baggage during the airport screening to the Information Systems Manager, U.S. What Telephone Number Do I Call To Make process. Department of Transportation, Research and an Immediate Notification of a Hazardous Also, you are not required to report Special Programs Administration, Office of Materials Incident? releases of minimal amounts of material (i.e., Hazardous Materials Safety, DHM–63, a pint or less) released from the manual You must call 800–424–8802 (toll-free) or Washington, DC 20590–0001; or operation of seals of pumps, compressors, or 202–267–2675 (toll-call) to make a telephonic • You can submit the report on-line at valves, during the connecting or incident report. This is the number to the http://hazmat.dot.gov. disconnecting of loading and unloading National Response Center. This call must be How Long Must I Keep a Copy of the Report? lines, or, for materials for which venting is made within 12 hours of the events that authorized, from vents, provided these trigger this requirement. If the incident You must keep a copy of each report or an releases do not result in property damage or involves an infectious substance, you may electronic image of the report for two years trigger any of the telephonic notifications notify the Director, Center for Disease Control after the date you submit it to RSPA requirements found in § 171.15. and Prevention (CDC), U.S. Public Health (§ 171.16(b)(3)). Service, Atlanta, Georgia, toll-free at 800– Where Must I Keep a Copy of the Report? When Must I Make a Telephonic Report? 232–0124. If a discrepancy of a shipment Under § 171.15, you must provide intended for air is discovered following its The report must be accessible through your telephone notice within 12 hours after the acceptance aboard aircraft, notify the nearest company’s principal place(s) of business. incident occurs when one of the following Federal Aviation Administration Civil You must be able to make the report available conditions occurs during the course of Aviation Security Office as soon as practical. upon request to authorized representatives or transportation and is a direct result of the a special agent of the Department within 24 hazardous material: How Long Do I Have To Submit the Written hours of such a request (§ 171.16(b)(3)). • A person is killed; Report? How Can I Get a Blank Copy of the Form F • A person receives an injury requiring You must submit your written report 5800.1? admittance to a hospital; within 30 days of discovery of the incident, • The general public is evacuated for one § 171.16(a). There are a variety of sources for obtaining hour or more; the Form F 5800.1. Please note that you are • One or more major transportation Am I Required To Update the Information in allowed to make unlimited photocopies of arteries or facilities are closed for one hour the Report? the form and distribute them. or more; Yes. You must use DOT Form F 5800.1 and • You may obtain limited copies of the • The operational flight plan or routine of check the ‘‘A supplemental (follow-up) form from the Information Systems Manager an aircraft is altered; report’’ box on question #2 to provide at the above address.

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• You may download a copy of the form noon, ‘‘0747’’ for 7:47 a.m., ‘‘2115’’ for 9:15 (20) Was the material shipped as a from our Web site at http://hazmat.dot.gov/ p.m.). hazardous waste? Check the ‘‘Yes’’ box if the spills.htm. (5) Enter National Response Center Report material meets the definition of a hazardous • Our Fax on Demand service has copies Number: If this incident was reported to the waste in § 171.8 (requires an EPA Uniform of the instructions and the form. Call 1–800– National Response Center (NRC), fill in the Hazardous Waste Manifest). Include the EPA 467–4922 and choose the Fax on Demand report number NRC assigned to the incident. Manifest number. option #2. (6) If you submitted a report to another (21) Is this a Toxic by Inhalation (TIH) Federal DOT agency, enter the agency and material? If the material involved in the How Long Does It Take To Complete the report number: If you were required to fill incident meets the definition of a Toxic by Report? out a report for another federal DOT agency Inhalation material in § 173.132, check the RSPA anticipates that it will take you such as the Federal Railroad Administration ‘‘Yes’’ box and enter the Hazard Zone in the approximately 1.6 hours to complete this or the Federal Motor Carrier Safety space provided. report. This estimate includes the time it will Administration for this incident, please (22) Was the material shipped under an take you to review the instructions, search include the agency and report number. This Exemption, Approval, or Competent your existing data sources for information, will facilitate our combination of Authority Certificate? If the shipment was gather the required data, and complete and information. shipped under an exemption, an approval, or review the report. (7) Location of Incident: Enter the a Competent Authority Certificate, check the geographic location of the incident (city, ‘‘Yes’’ box and provide the appropriate How Can I Comment on the Length of Time county, state, and zip code). If you do not assigned number. Needed To Complete the Report or on the know the actual location where the incident (23) Was this an undeclared hazardous Amount of Information Required in the occurred, give the location where it was materials shipment? If this material was not Report? discovered. If the incident occurred at an indicated in any way to be a hazardous You can send your comments on the airport or rail yard, include the name of the material even though it was required to be report, and any suggestions you have for facility. If the incident occurred on a body of described as such on a shipping paper, or if reducing the amount of time needed to water, include the name and/or river mile. If the material would normally be excepted complete the report, to the following address: you do not know the street address, or if the from the shipping paper requirements (such (1) Information Systems Manager, U.S. incident occurred on a highway, include a as a small quantity material) and does not Department of Transportation, Research and description such as ‘‘On I–70, mile marker have the required markings, it is considered Special Programs Administration, Office of 240.’’ an undeclared hazardous material shipment. Hazardous Materials Safety, DHM–63, (8) Mode of Transportation: Enter the code Check the appropriate box. Washington, DC 20590–0001. that corresponds to the mode of Part III: Packaging Information Please verify that your information is transportation in which the incident (24) Packaging Type: Check the box that accurate. Although the required information occurred or was discovered. If the incident corresponds to the type of packaging is generally available at the time of the occurred or was discovered in an in-transit involved in the incident. If more than one incident, you may need to do some storage area (e.g., a terminal or warehouse), packaging type was involved in an incident, additional investigation in order to obtain all check the box that corresponds to the mode of the facts pertaining to deaths, injuries or reproduce Part III of the form and fill out this by which the package was last transported. section for each of the packaging types. For damage amounts. If you submit complete and (9) Transportation Phase: Enter the code accurate information at the time you file the example, if three different packaging types that describes where the incident occurred in were involved in an incident, fill out a report, it will decrease the chance of your the transportation system. In transit means having to supply missing information to DOT separate Part III for each packaging type. If the incident occurred or was first discovered the type of packaging is not represented, at a later date. RSPA may follow up on while the package was in the process of being incomplete forms. check the ‘‘Other’’ box and enter a brief transported. In-transit storage is storage description such as ‘‘non-specification bulk Instructions for Form DOT F 5800.1 incidental to transportation, such as at a bin.’’ terminal waiting for the next leg of Please print. Fill in all applicable blanks (25) Enter the appropriate failure codes transportation. accurately to the best of your ability. (found at the end of the instructions): Enter (10) Carrier/Reporter: Provide the name, the codes that describe what failed on the Part I: Report Type street address, Federal DOT number (if packaging, how the packaging failed, and the (1) This is to report: Check the box that applicable), and hazmat registration number cause(s) of the failure. Be sure to enter the describes why you are filling out this form. of the carrier or the entity who is reporting codes from the list that corresponds to the This will normally be ‘‘A) A hazardous the incident (if other than a carrier). The particular packaging types checked above material incident.’’ If you are reporting an entity in physical possession of the material (#24). Enter the most important failure point undeclared shipment with no release, check when the incident occurred or was in line 1. If there is a second failure point, the corresponding box, ‘‘B).’’ If you are discovered must report the incident. enter in line 2. If there are more than two reporting an incident involving a cargo tank (11) Shipper/Offeror: Enter the information failure points, provide additional information motor vehicle containing a hazardous about the person or entity that originally in this format in Part VI. The following material that received structural damage to offered for transportation the material or explains the content of each line: the lading retention system that may affect its package involved in the incident. What Failed: You can enter up to 2 ‘‘What ability to retain lading but does not release (12) Origin: Enter the origin of the Failed’’ codes to describe the part of the a hazardous material, check that appropriate shipment if the address is different than the packaging that fails and was the immediate box, ‘‘C).’’ shipper/offeror information entered in item cause of the release. Often, on a simple (2) Indicate what type of report this is: If #11. packaging, only one code will be required. this is an initial report, check the ‘‘initial (13) Destination: Enter the final destination On more complex packaging, additional report’’ box. If this is a follow-up to a of the shipment involved in the incident. entries will help identify where that failure previous report, check the ‘‘A supplemental (14) through (19): occurred. The first entry should designate the (follow-up) report’’ box. If you are using Hazardous Material Description: Enter the specific point of failure, followed by entries additional pages, check the ‘‘Additional proper shipping name, technical or trade that help identify where that failure Pages’’ box. name, hazard class or division, ID number, occurred. For instance, a deteriorated gasket packing group, and amount of material on a pipe flange on the liquid line would Part II: General Incident Information released. All of this information, except the have failure code 121 for gasket entered first (3), (4) Date & Time of Incident: Enter the amount of material released, can be found on and failure code 118 for flange entered date and time the incident occurred. If you the shipping papers that accompany the second. do not know the actual date and time, give shipment, § 172.202. When indicating the How Failed: Enter the ‘‘Failure’’ code that the date and time you discovered the amount of material released, include units of describes how the corresponding part of the incident. Use 24-hour time for the incident measurements (examples: 115 gallons, 69 packaging failed. The primary way the time (e.g. ‘‘2400’’ for midnight, ‘‘1200’’ for tons). packaging failed should be entered first.

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Cause(s) of Failure: Enter the ‘‘Cause of 3—Composite shipper’s invoice. If the invoice is not Failure’’ code that describes what caused the 4—Fiberboard available, estimate the cost per unit using the corresponding part of the packaging to fail in 5—Wooden shipper’s basis. the way it did. The most probable or 6—Flexible Carrier Damage: Enter the total value of fundamental cause of failure should be (27) Describe the package capacity and the damage incurred by the carrier. Major entered first. quantity: Enter the total capacity of the inner components include costs to repair the If none of the codes on the list fit exactly, and outer package. Also enter the actual damaged vehicle and costs resulting from use the closest matches and provide amount of hazardous material that was damage to cargo. If the vehicle is declared additional detail in Part VI. Also, if you shipped in the package, the number of ‘‘totaled,’’ enter the insured value of the believe a better set of codes would be more packages in the shipment, and the number of vehicle. This entry should not include descriptive of what failed, how it failed, and packages that failed. Please include the units damage to other property or to vehicles the causes of failure, suggest them in Part VII. of measurement (liter, gallons, pounds, cubic owned by other persons. (26a) Provide the complete packaging feet, etc.) Property Damage: Enter the total value of identification markings, if available: Every (28) Provide package construction and test costs resulting from damage to the property specification packaging, UN or DOT, has a information, as appropriate: In the case of of others involved in the incident. These packaging identification printed or stamped Non-bulk packagings or IBCs enter the name include: repair and replacement costs of on it or on a plate attached to the packaging. of the packaging manufacturer or the symbol other vehicles; repair and replacement costs Examples are provided on the form. of the manufacturer only if complete to buildings and other fixed facilities; and (26b) For Non-bulk, IBC, or non- identification markings were not provided in restoration of open land beyond specification packaging: Only fill out 26b if #26b. Enter the date of manufacture and the decontamination and cleanup. the marking is incomplete, destroyed, or serial number, if applicable. Enter the last Response Cost: Enter the total value of unknown. Fill in the Outer and Inner test date if the packaging requires periodic response costs. Response costs are those costs packaging type and material of construction testing. Also include the design pressure, incurred immediately after the incident, and information, as appropriate. If the packaging shell thickness, head thickness, and service include local emergency response from is Non-bulk or Intermediate Bulk Container pressure if the failed packagings are of the police and fire departments and emergency (IBC), use the codes below to enter the type indicated in parenthesis after each response teams, as well as costs incurred by number or letter that applies for either Non- question. If the packaging contained a valve, the responsible party. Response costs also bulk or IBC packaging. For non-bulk, IBC or or other device that failed and resulted in a include costs to contain the hazardous non-specification packaging provide a hazardous material release, enter the valve or material released. description of the packaging in the space(s) device type, manufacturer (if present and Remediation/Cleanup Cost: Enter the total provided. legible), and model number (if present and value of the cost to cleanup and remediate Non-Bulk Packaging Identification Codes legible). the site. Cleanup costs are those costs (29) If the package is for Radioactive incurred to collect, transport, and ultimately Outer Packaging Materials, complete the following: Complete dispose of all material collected during the Type this question only if a radioactive material response phase. Remediation costs are those 1 = Drum was involved. Indicate the packaging costs incurred to restore the incident scene 2 = Wooden Barrel category, the packaging certification, to its pre-incident state, and could include 3 = Jerrican certification number, and which nuclides excavation, disposal and replacement of 4 = Box were present, the transportation index (TI), contaminated soil, pumping, treatment and 5 = Bag activity of the nuclides, and the criticality re-injection of contaminated groundwater, or 6 = Composite Packaging safety index. absorption and disposal of hazardous 7 = Pressure receptacle material released into surface water. Part IV: Consequences Material (33a) Did the hazardous material cause or A = Steel (30) Result of Incident: Check all boxes that contribute to a human fatality? If a person B = Aluminum describe what occurred during the incident was fatally injured by contact with the C = Natural Wood or as a result of the incident. For example, hazardous material or its vapors or by a fire D = Plywood in a situation where a truckload of 55 gallon or explosion that resulted from the hazardous F = Reconstituted Wood drums of corrosive liquids overturns material, check the ‘‘Yes’’ box and enter the G = Fiberboard resulting in a release that contaminates a number of fatalities that resulted directly H = Plastic nearby wetlands and stream the boxes from the hazardous material. L = Textile ‘‘Spillage,’’ ‘‘Material Entered Waterway/ (33b) Were there human fatalities that did M = Paper, multi-wall Storm Sewer,’’ and ‘‘Environmental Damage’’ not result from the hazardous material? If the N = Metal other than steel or aluminum may apply. fatalities were not caused directly by the P = Glass, porcelain, or stoneware (31) Emergency Response: Check all boxes hazardous material, check the ‘‘Yes’’ box and Head Type that correspond with any emergency enter the number of fatalities. An example: if 1 = Non-removable response and cleanup crews that participated a passenger car collided with a cargo tank 2 = Removable in resolving the incident. If a fire crew, EMS, carrying gasoline and the automobile driver or police unit responded to the incident, Inner Packaging was killed due to the collision, then the include the report number. fatality was not caused by the hazardous Type (32) Damages: You are required to provide material released. If, however, the accident 1 = Bottle information on estimated damages if your resulted in the release of gasoline from the 2 = Can damages exceed $500.00. This figure cargo tank and a resulting fire killed the 3 = Box includes the cost of the material lost, automobile driver, then the fatality was 4 = Bag property damage, vehicle damage, response caused by the hazardous material. 5 = Cylinder costs, and clean-up costs. If you do not know (34) Did the hazardous material cause or Material these amounts at the time you complete the contribute to a personal injury? If a person A = Metal (any type) report, or the actual costs are revised by more was injured by contact with the hazardous B = Glass, porcelain, or stoneware than $25,000, you must submit a follow-up material or its vapors or by a fire or explosion C = Plastic report after you determine the amounts. The that resulted from the hazardous material, D = Fiberboard or cardboard following definitions explain each of the check the ‘‘Yes’’ box and enter the number E = Wood (any type) costs: of persons injured by the hazardous material. IBC Packaging Identification Codes Material Loss: Enter the value of material Hospitalized means admitted to a medical released and unrecoverable. Base this entry facility, not treated and released from a Material of Construction on the amount of material released facility, such as a hospital emergency room, 1—Metal multiplied by the unit value (e.g., price per where the person was never admitted to the 2—Plastic gallon or price per pound) as listed on the hospital proper. Non-hospitalized

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individuals are those who may have received Part VII: Recommendations/Actions Taken 140 Outer Frame attention from medical personnel on-site or To Prevent Future Incidents 141 Piping or Fittings at a facility (including hospital emergency Recommendations may be preliminary in 142 Piping Shear Section room), but were not admitted to a medical nature, may suggest actions by other parties, 143 Pressure Relief Valve or Device—Non- facility. Indicate the number of injured and may be subject to further investigation, Reclosing employees, emergency responders refinement, acceptance, or rejection. Often, it 144 Pressure Relief Valve or Device— (firefighters, police, medics, etc.) and may be beyond the ability of the preparer to Reclosing members of the general public. offer recommendations, but where such 145 Remote Control Device (35) Did the hazardous material cause or recommendations can be made they have the 146 Sample Line contribute to an evacuation? If the incident potential of resulting in important 147 Stub Still (Tank Car) required the evacuation or removal of improvements with safety benefits. For 148 Sump persons from a specific area because of instance, such information can help 149 Tank Head possible or actual contact with the hazardous companies identify common problems and 150 Tank Shell materials involved in the incident, check the alert the DOT to the need for additional 151 Thermometer Well 152 Threaded Connection ‘‘Yes’’ box. Separately specify the numbers of measures such as outreach or broad training 153 Vacuum Relief Valve individuals from the general public needs. This information can also help 154 Valve Body evacuated and number of employees of the support regulatory changes. 155 Valve Seat facility or workers in the area that were Part VIII: Contact Information 156 Valve Spring evacuated. Also provide the total number of 157 Valve Stem individuals evacuated. Indicate the duration Provide the name, title, telephone number, fax number, business name and address, 158 Vapor Valve of the evacuation (in hours). 159 Vent (36) Was a transportation artery or facility hazmat registration number and email address of the contact person at your 160 Washout closed? If a road or transportation facility was company who can answer questions about 161 Weld or Seam closed due to the incident, check the ‘‘Yes’’ the information provided on this form. Make box and indicate the duration (in hours) here. Code How Failed sure to check the box that describes the (37) Was the material involved in a crash 301 Abraded function of your firm: carrier, shipper, or derailment? Check the ‘‘Yes’’ box if a 302 Bent facility owner/operator, or other. If ‘‘Other’’ hazardous material was involved in a crash 303 Burst or Ruptured is checked, describe the function. or derailment. Provide the estimated speed 304 Cracked and weather conditions at the time of the Instructions for Form DOT F 5800.1— 305 Crushed crash, such as rain, blowing snow, sleet, iced Failure Codes for Part 3 of Form DOT F 306 Failed to Operate roadway, sun glare, fog, dry pavement, high 5800.1 307 Gouged or Cut winds, etc. Indicate if the vehicle overturned 308 Leaked Complete Listing—All Packaging Types or left the roadway or track. 309 Punctured Code What Failed 310 Ripped or Torn Part V: Air Incident Information 311 Structural 101 Air Inlet 312 Torn Off or Damaged This section is for incidents with 102 Auxiliary Valve 313 Vented packagings transported or intended for 103 Basic Material transportation by aircraft. If your packaging 104 Body Code Cause(s) of Failure was not transported or intended to be 105 Bolts or Nuts 501 Abrasion transported by air, skip this section. 106 Bottom Outlet Valve 502 Broken Component or Device (38) Was the shipment on a passenger 107 Check Valve 503 Commodity Self-ignition aircraft? Indicate whether the shipment in 108 Chime 504 Commodity Polymerization question was on a commercial passenger 109 Closure (e.g., Cap, Top, or Plug) 505 Conveyer or Material Handling aircraft. If so, indicate if the material was 110 Cover Equipment Mishap tendered (accepted for shipment) as cargo, or 111 Cylinder Neck or Shoulder 506 Corrosion—Exterior was located in a passenger’s baggage, either 112 Cylinder Sidewall—Near Base 507 Corrosion—Interior in the cabin or baggage compartment. 113 Cylinder Sidewall—Other 508 Defective Component or Device (39) Where did the incident occur or where 114 Cylinder Valve 509 Derailment was the incident discovered? Indicate where 115 Discharge Valve or Coupling 510 Deterioration or Aging in the course of transportation the incident 116 Excess Flow Valve 511 Dropped occurred or was discovered. 117 Fill Hole 512 Fire, Temperature, or Heat (40) What phase(s) had the shipment 118 Flange 513 Forklift Accident already undergone prior to the incident? 119 Frangible Disc 514 Freezing Check all boxes that describe the 120 Fusible Pressure Relief Device or 515 Human Error transportation phases the shipment went Element 516 Impact with Sharp or Protruding Object through before the incident occurred or was 121 Gasket (e.g., nails) discovered. 122 Gauging Device 517 Improper Preparation for 123 Heater Coil Transportation Part VI: Description of Events and Packaging 124 High Level Sensor 518 Inadequate Accident Damage Failure 125 Hose Protection Please describe the events involved in the 126 Hose Adaptor or Coupling 519 Inadequate Blocking and Bracing incident to provide us with a better 127 Inlet (Loading) Valve 520 Inadequate Maintenance understanding of the incident. Include 128 Inner Packaging 521 Inadequate Preparation for information that has not been collected 129 Inner Receptacle Transportation elsewhere on this form, and include special 130 Lifting Feature 522 Inadequate Procedures scenarios, outstanding circumstances, or 131 Lifting Lug 523 Inadequate Training other information that provides a complete 132 Liner 524 Incompatible Product picture of the incident. Describe the sequence 133 Liquid Line 525 Incorrectly Sized Component or Device of events that led to the incident, the package 134 Liquid Valve 526 Loose Closure, Component, or Device failure (if any) and actions taken at the time 135 Loading or Unloading Lines 527 Misaligned Material, Component, or of discovery. Submit photographs and 136 Locking Bar Device diagrams when necessary for clarification. 137 Manway or Dome Cover 528 Missing Component or Device You may continue on additional sheets if 138 Mounting Studs 529 Overfilled necessary. 139 O-Ring or Seals 530 Overpressurized

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531 Rollover Accident 538 Water Damage 121 Gasket 532 Stub Sill Separation from Tank (Tank 122 Gauging Device Cylinders Cars) 125 Hose 533 Threads Worn or Cross Threaded Code What Failed 127 Inlet (Loading) Valve 534 Too Much Weight on Package 111 Cylinder Neck or Shoulder 131 Lifting Lug 535 Valve Open 112 Cylinder Sidewall—Near Base 132 Liner 536 Vandalism 113 Cylinder Sidewall—Other 135 Loading or Unloading Lines 537 Vehicular Crash or Accident Damage 114 Cylinder Valve 137 Manway or Dome Cover 538 Water Damage 119 Frangible Disc 140 Outer Frame 141 Piping or Fittings General Non-bulk and IBCs 120 Fusible Pressure Relief Device or Element 143 Pressure Relief Valve or Device—Non- Code What Failed 122 Gauging Device Reclosing 103 Basic Material 132 Liner 144 Pressure Relief Valve or Device— 104 Body 143 Pressure Relief Valve or Device—Non- Reclosing 105 Bolts or Nuts Reclosing 152 Threaded Connection 108 Chime 144 Pressure Relief Valve or Device— 153 Vacuum Relief Valve 109 Closure (e.g., Cap, Top, or Plug) Reclosing 161 Weld or Seam 110 Cover 161 Weld or Seam Code How Failed 119 Frangible Disc Code How Failed 301 Abraded 120 Fusible Pressure Relief Device or 301 Abraded 302 Bent Element 303 Burst or Ruptured 303 Burst or Ruptured 121 Gasket 304 Cracked 304 Cracked 125 Hose 306 Failed to Operate 305 Crushed 128 Inner Packaging 307 Gouged or Cut 306 Failed to Operate 129 Inner Receptacle 308 Leaked 307 Gouged or Cut 130 Lifting Feature 309 Punctured 308 Leaked 132 Liner 313 Vented 309 Punctured 140 Outer Frame Code Cause(s) of Failure 310 Ripped or Torn 143 Pressure Relief Valve or Device—Non- 312 Torn Off or Damaged Reclosing 501 Abrasion 313 Vented 144 Pressure Relief Valve or Device— 502 Broken Component or Device Reclosing 503 Commodity Self-ignition Code Cause(s) of Failure 161 Weld or Seam 504 Commodity Polymerization 501 Abrasion Code How Failed 505 Conveyer or Material Handling 502 Broken Component or Device Equipment Mishap 503 Commodity Self-ignition 301 Abraded 506 Corrosion—Exterior 504 Commodity Polymerization 302 Bent 507 Corrosion—Interior 505 Conveyer or Material Handling 303 Burst or Ruptured 508 Defective Component or Device Equipment Mishap 304 Cracked 510 Deterioration or Aging 506 Corrosion—Exterior 305 Crushed 512 Fire, Temperature, or Heat 507 Corrosion—Interior 306 Failed to Operate 513 Forklift Accident 508 Defective Component or Device 307 Gouged or Cut 514 Freezing 509 Derailment 308 Leaked 515 Human Error 510 Deterioration or Aging 309 Punctured 516 Impact with Sharp or Protruding Object 511 Dropped 310 Ripped or Torn (e.g., nails) 512 Fire, Temperature, or Heat 311 Structural 517 Improper Preparation for 514 Freezing 312 Torn Off or Damaged Transportation 515 Human Error 313 Vented 519 Inadequate Blocking and Bracing 517 Improper Preparation for Code Causes of Failure 520 Inadequate Maintenance Transportation 501 Abrasion 521 Inadequate Preparation for 520 Inadequate Maintenance 503 Commodity Self-ignition Transportation 521 Inadequate Preparation for 504 Commodity Polymerization 522 Inadequate Procedures Transportation 505 Conveyer or Material Handling 523 Inadequate Training 522 Inadequate Procedures Equipment Mishap 524 Incompatible Product 523 Inadequate Training 506 Corrosion—Exterior 525 Incorrectly Sized Component or Device 524 Incompatible Product 507 Corrosion—Interior 526 Loose Closure, Component, or Device 525 Incorrectly Sized Component or Device 508 Defective Component or Device 527 Misaligned Material, Component, or 526 Loose Closure, Component, or Device 510 Deterioration or Aging Device 527 Misaligned Material, Component, or 511 Dropped 528 Missing Component or Device Device 513 Forklift Accident 529 Overfilled 528 Missing Component or Device 514 Freezing 530 Overpressurized 529 Overfilled 515 Human Error 535 Valve Open 530 Overpressurized 516 Impact with Sharp or Protruding Object 536 Vandalism 531 Rollover Accident (e.g., nails) 537 Vehicular Crash or Accident Damage 536 Vandalism 537 Vehicular Crash or Accident Damage 517 Improper Preparation for Portable Tanks Transportation Code What Failed Bulk Tank Vehicles—Cargo Tank Motor 521 Inadequate Preparation for Vehicles (CTMV) and Tank Cars Transportation 105 Bolts or Nuts 522 Inadequate Procedures 106 Bottom Outlet Valve Code What Failed 523 Inadequate Training 107 Check Valve 101 Air Inlet 529 Overfilled 108 Chime 105 Bolts or Nuts 530 Overpressurized 109 Closure (e.g., Cap, Top, or Plug) 106 Bottom Outlet Valve 534 Too Much Weight on Package 110 Cover 107 Check Valve 535 Valve Open 119 Frangible Disc 110 Cover 536 Vandalism 120 Fusible Pressure Relief Device or 115 Discharge Valve or Coupling 537 Vehicular Crash or Accident Damage Element 116 Excess Flow Valve

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117 Fill Hole 518 Inadequate Accident Damage radioactive material (see also § 176.48 of this 118 Flange Protection subchapter); 119 Frangible Disc 519 Inadequate Blocking and Bracing (3) Fire, breakage, spillage, or suspected 120 Fusible Pressure Relief Device or 520 Inadequate Maintenance contamination occurs involving an infectious Element 521 Inadequate Preparation for substance other than a diagnostic specimen 121 Gasket Transportation or regulated medical waste; 122 Gauging Device 522 Inadequate Procedures (4) A release of a marine pollutant occurs 123 Heater Coil 523 Inadequate Training in a quantity exceeding 450 L (119 gallons) 124 High Level Sensor 524 Incompatible Product for a liquid or 400 kg (882 pounds) for a 125 Hose 525 Incorrectly Sized Component or Device solid; or 126 Hose Adaptor or Coupling 526 Loose Closure, Component, or Device (5) A situation exists of such a nature (e.g., 127 Inlet (Loading) Valve 527 Misaligned Material, Component, or a continuing danger to life exists at the scene 131 Lifting Lug Device of the incident) that, in the judgment of the 132 Liner 528 Missing Component or Device person in possession of the hazardous 133 Liquid Line 529 Overfilled material, it should be reported to the NRC 134 Liquid Valve 530 Overpressurized even though it does not meet the criteria of 135 Loading or Unloading Lines 531 Rollover Accident paragraph (b)(1), (2), (3) or (4) of this section. 136 Locking Bar 532 Stub Sill Separation from Tank (Tank (c) Written report. Each person making a 137 Manway or Dome Cover Cars) report under this section must also make the 138 Mounting Studs 533 Threads Worn or Cross Threaded report required by § 171.16 of this subpart. 139 O-Ring or Seals 536 Vandalism Note to § 171.15: Under 40 CFR 302.6, EPA 141 Piping or Fittings 537 Vehicular Crash or Accident Damage requires persons in charge of facilities 142 Piping Shear Section (including transport vehicles, vessels, and 143 Pressure Relief Valve or Device—Non- Hazardous Materials Regulations 49 CFR aircraft) to report any release of a hazardous Reclosing Sections 171.15 and 171.16 substance in a quantity equal to or greater 144 Pressure Relief Valve or Device— than its reportable quantity, as soon as that Reclosing § 171.15—Immediate notice of certain hazardous materials incidents. person has knowledge of the release, to 145 Remote Control Device DOT’s National Response Center at (toll free) 146 Sample Line (a) General. As soon as practical but no 800–424–8802 or (toll) 202–267–2675. 147 Stub Sill (Tank Car) later than 12 hours after the occurrence of 148 Sump any incident described in paragraph (b) of § 171.16—Detailed hazardous materials 149 Tank Head this section, each person in physical incident reports. 150 Tank Shell possession of the hazardous material must (a) General. Each person in physical 151 Thermometer Well provide notice by telephone to the National possession of a hazardous material at the 152 Threaded Connection Response Center (NRC) on 800–424–8802 time that any of the following incidents 153 Vacuum Relief Valve (toll free) or 202–267–2675 (toll call). Notice occurs during transportation (including 154 Valve Body involving an infectious substance (etiologic loading, unloading, and temporary storage) 155 Valve Seat agent) may be given to the Director, Centers must submit a Hazardous Materials Incident 156 Valve Spring for Disease Control and Prevention, U.S. Report on DOT Form F 5800.1 (01–2004) 157 Valve Stem Public Health Service, Atlanta, GA, 800–232– within 30 days of discovery of the incident: 158 Vapor Valve 0124 (toll free), in place of notice to the NRC. (1) Any of the circumstances set forth in 159 Vent Each notice must include the following § 171.15(b); 160 Washout information: (2) An unintentional release of a hazardous 161 Weld or Seam (1) Name of reporter; material or the discharge of any quantity of Code How Failed (2) Name and address of person hazardous waste; 301 Abraded represented by reporter; (3) A specification cargo tank with a 302 Bent (3) Phone number where reporter can be capacity of 1,000 gallons or greater 303 Burst or Ruptured contacted; containing any hazardous material suffers 304 Cracked (4) Date, time, and location of incident; structural damage to the lading retention 305 Crushed (5) The extent of injury, if any; system or damage that requires repair to a 306 Failed to Operate (6) Class or division, proper shipping system intended to protect the lading 307 Gouged or Cut name, and quantity of hazardous materials retention system, even if there is no release 308 Leaked involved, if such information is available; of hazardous material; or 309 Punctured and (4) An undeclared hazardous material is 310 Ripped or Torn (7) Type of incident and nature of discovered. 311 Structural hazardous material involvement and whether (b) Providing and retaining copies of the 312 Torn Off or Damaged a continuing danger to life exists at the scene. report. Each person reporting under this 313 Vented (b) Reportable incident. A telephone report section must— is required whenever any of the following (1) Submit a written Hazardous Materials Code Cause(s) of Failure occurs during the course of transportation in Incident Report to the Information Systems 501 Abrasion commerce (including loading, unloading, and Manager, DHM–63, Research and Special 502 Broken Component or Device temporary storage): Programs Administration, Department of 503 Commodity Self-ignition (1) As a direct result of a hazardous Transportation, Washington, DC 20590–0001, 504 Commodity Polymerization material— or an electronic Hazardous Material Incident 505 Conveyer or Material Handling (i) A person is killed; Report to the Information System Manager, Equipment Mishap (ii) A person receives an injury requiring DHM–63, Research and Special Programs 506 Corrosion—Exterior admittance to a hospital; Administration, Department of 507 Corrosion—Interior (iii) The general public is evacuated for one Transportation, Washington, DC 20590–0001 508 Defective Component or Device hour or more; at http://hazmat.dot.gov; 509 Derailment (iv) A major transportation artery or facility (2) For an incident involving transportation 510 Deterioration or Aging is closed or shut down for one hour or more; by aircraft, submit a written or electronic 511 Dropped or copy of the Hazardous Materials Incident 512 Fire, Temperature, or Heat (v) The operational flight pattern or routine Report to the FAA Security Field Office 515 Human Error of an aircraft is altered; nearest the location of the incident; and 517 Improper Preparation for (2) Fire, breakage, spillage, or suspected (3) Retain a written or electronic copy of Transportation radioactive contamination occurs involving a the Hazardous Materials Incident Report for

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a period of two years at the reporting (4) Damage, loss, or related cost changes by (ii) Each packaging has a capacity of less person’s principal place of business. If the $25,000 or more, or 10% of the prior total than 20 liters (5.2 gallons) for liquids or less written or electronic Hazardous Materials estimate, whichever is greater. than 30 kg (66 pounds) for solids; Incident Report is maintained at other than (d) Exceptions. Unless a telephone report (iii) The total aggregate release is less than the reporting person’s principal place of is required under the provisions of § 171.15 20 liters (5.2 gallons) for liquids or less than business, the report must be made available of this part, the requirements of paragraphs at the reporting person’s principal place of (a), (b), and (c) of this section do not apply 30 kg (66 pounds) for solids; and business within 24 hours of a request for the to the following incidents: (iv) The material is not— report by an authorized representative or (1) A release of a minimal amount of (A) offered for transportation or special agent of the Department of material from— transported by aircraft, Transportation. (i) a vent, for materials for which venting (B) a hazardous waste, or (c) Updating the incident report. A is authorized; (C) an undeclared hazardous material. Hazardous Materials Incident Report must be (ii) the routine operation of a seal, pump, (3) An undeclared hazardous material updated within one year of the date of compressor, or valve; or discovered in an air passenger’s checked or occurrence of the incident whenever: (iii) connection or disconnection of loading carry-on baggage during the airport screening (1) A death results from injury caused by or unloading lines, provided that the release a hazardous material; does not result in property damage. process. (For discrepancy reporting by (2) There was a misidentification of the (2) An unintentional release of hazardous carriers, see § 175.31 of this subchapter.) hazardous material or packaging information material when: [FR Doc. 04–11398 Filed 5–25–04; 8:45 am] on a prior incident report; (i) The material is properly classed as— (3) Damage, loss or related cost that was (A) ORM–D; or BILLING CODE 4910–60–P not known when the initial incident report (B) a Packing Group III material in Class or was filed becomes known; or Division 3, 4, 5, 6.1, 8, or 9;

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Part VII

Department of Labor Delegation of Authorities and Assignment of Responsibilities for the Department of Labor’s Internal Equal Employment Opportunity Programs; Notice

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DEPARTMENT OF LABOR (‘‘ASAM’’) is delegated authority and Office of the Inspector General, which assigned responsibility for: will be issued by the Secretary; Office of the Secretary (1) Administering a comprehensive, (3) Appointing counselors, fact- [Secretary’s Order 1–2004] department-wide program to carry out finders, mediators or other individuals the Department’s equal employment to engage in alternative dispute Delegation of Authorities and opportunity policy and fulfilling the resolution; Assignment of Responsibilities for the Department’s obligations arising from (4) Preparing such EEO-related reports Department of Labor’s Internal Equal equal employment opportunity statutes as may be required by the EEOC or the Employment Opportunity Programs and their implementing executive Office of Personnel Management, except orders, rules, regulations, and the DVAAP plan, the FEORP plan and 1. Purpose. To establish policy, guidelines covering Federal employees Affirmative Employment Program Plan delegate authority, and assign and applicants for Federal employment; for Individuals with Disabilities; responsibility for complying with and (2) Appointing Departmental (5) Advising the Secretary of Labor, enforcing equal employment managers for special emphasis through the ASAM, about the status of opportunity (EEO) laws and regulations programs, such as the Federal Women’s equal employment opportunity applicable to Federal employment in the Program, Hispanic Employment throughout DOL; Department of Labor (DOL). Program, and the Disability (6) Recommending changes to 2. Authority and Directives Affected. Employment Program; programs and procedures designed to a. Authority. This Order is issued (3) Preparing Employment Program eliminate practices that act as barriers to pursuant to civil rights and plans for women and minorities and the hiring and advancement of women, nondiscrimination statutes, executive making recommendations to Agency minorities, and persons with orders, and implementing regulations Heads for any necessary modifications disabilities, with the goal of improving related to Federal employment and prior to preparing and forwarding the the Department’s overall EEO Program; equal employment opportunity Departmental plan to the Secretary of (7) Advising the agencies about programs. This includes, but is not Labor for transmittal to EEOC; physical and program accessibility limited to: Title VII of the Civil Rights issues that affect individuals with (4) Preparing the Department’s Act of 1964, as amended; the Equal Pay disabilities; Disabled Veterans Affirmative Action Act; the Age Discrimination in (8) Evaluating the sufficiency of the Program (DVAAP), Federal Equal Employment Act of 1967, as amended, total Agency program for equal Employment Opportunity Recruitment the Rehabilitation Act of 1973, as employment opportunity and reporting Program (FEORP) plans, and the amended; the Civil Service Reform Act to the head of the Agency with Affirmative Employment Program Plan of 1978; the Civil Rights Act of 1991; the recommendations as to any for Individuals with Disabilities; No FEAR Act; Executive Order 11478, improvements or corrections needed, (5) Providing effective leadership in as amended; Executive Order 11375, as including remedial and disciplinary the implementation of special amended; Executive Order 13145; action with respect to managerial, employment programs, such as the Executive Order 13163; Executive Order supervisory or other employees who Federal Women’s Program and the 13164; Executive Order 13171; 5 U.S.C. have failed in their responsibilities; 720 (marital status and political Hispanic Employment Program; and (9) Reviewing appeal affiliation); 5 U.S.C. 7201 (Federal Equal (6) Making further delegations of the recommendations by a Department of Opportunity Recruitment Program); 38 authority and assignments of the Labor Agency and counsel representing U.S.C. 4214 (Disabled Veterans responsibility described in 5a of this the Agency at hearings before the EEOC Affirmative Action Plan); 29 U.S.C. 791 Order. and deciding, with the concurrence of (Affirmative Action Program Plan for b. The Director of the Civil Rights the Office of the Solicitor, whether to Individuals with Disabilities); 38 U.S.C. Center (‘‘CRC’’), within the Office of the appeal adverse decisions issued by 4212 (Vietnam Era Veterans’ Assistant Secretary for Administration EEOC administrative judges; and Readjustment Assistance Act of 1974), and Management, is delegated the (10) Making further delegations of as amended; 29 CFR 1614 (EEOC authority and assigned the authority and assignments of the Complaint Procedures Regulations); and responsibility for: responsibilities described in 5b of this the Equal Employment Opportunity (1) Administering all aspects of the Order. Commission’s (EEOC) Management administrative processing of c. The Solicitor of Labor is delegated Directives 110 (Complaint Processing) discrimination complaints filed by authority and assigned responsibility for and 715 (Affirmative Action). employees and applicants for the following aspects of the b. Directives Affected. Secretary’s employment in accordance with 29 CFR Department’s EEO program: Order 03–96 is cancelled. part 1614 including, but not limited to, (1) Providing counsel to the Secretary, 3. Policy. It is the policy of the providing for counseling, alternative ASAM, the Director of the CRC, and Department to provide equal dispute resolution, and investigation of Agency Heads in implementing the employment opportunity for all DOL such complaints, except those that Department’s EEO program; employees and applicants for DOL include allegations against the CRC, the (2) Providing legal representation to employment in accordance with immediate office of the ASAM and for the Department at hearings and court applicable federal statutes, regulations, other complaints determined by the proceedings arising out of the EEO executive orders and departmental Director of the CRC to constitute a program; policy. potential conflict of interest; (3) Providing legal advice to 4. Scope. This Order applies to all (2) Issuing final decisions and taking managers, supervisors, and other DOL personnel, organizational final actions on discrimination employees who are assisting components, and activities. complaints in a timely manner in management in personnel matters 5. Delegation of Authority and accordance with 29 CFR part 1614, during the course of their official duties, Assignment of Responsibilities. except those decisions on complaints and who, in their official capacity, a. The Assistant Secretary for filed by employees and applicants for request a review of their EEO affidavits Administration and Management employment arising from within the prior to their submission to an EEO

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investigator for inclusion in the EEO Department’s EEO program and policies complaint filed against the Agency file; within the Agency pursuant to policy including, but not limited to, Agency (4) Providing advice and counsel to direction from the ASAM and EEO counselor training and travel as the CRC regarding appeal procedural guidance from the Director may be required, all hearing costs, recommendations as described in 5b(9) of the CRC or the officials acting in settlement costs, including of this Order; and those capacities. Such responsibilities compensatory damages, and attorney (5) Making further delegations of include, but are not limited to, the fees as may be applicable; and authority and assignments of the following: (5) Making further delegations of the responsibilities described in 5c of this (1) Providing active support of, and authority and assignment of Order. participation in, the planning and d. The Chair of the Administrative responsibilities described in 5e of this implementation of affirmative Order. Review Board is delegated authority and employment and special emphasis f. The Office of the Chief Financial assigned responsibility for the following program initiatives including the Officer is delegated authority and aspects of the Department’s EEO appointment of EEO Coordinators and assigned responsibility for the following programs: the establishment of EEO Committees; (1) Providing for all aspects of the aspects of the Department’s EEO (2) Assuring full and prompt administrative processing of programs: cooperation of Agency employees and discrimination complaints including the (1) Processing the payment of all assignment of counselors, investigators, officials with DOL’s EEO policies, procedures, and direction from officials awards and/or settlement agreements and the issuance of final decisions in resulting from EEO complaints; and complaints involving allegations of charged with implementing DOL’s equal discrimination against the CRC, the employment opportunity program; (2) Making further delegations of the immediate office of the ASAM, and for (3) Providing sufficient Agency funds authority and assignment of those complaints determined by the and other resources to assure effective responsibilities described in 5f of this Director of the CRC to constitute a implementation of DOL’s EEO policies Order. potential conflict of interest; and and procedures including training of 6. Effective Date. This Order is (2) Making further delegations of the employees on EEO matters, effective immediately. authority and assignment of expenditures related to reasonable Dated: April 15, 2004. responsibilities described in 5d of this accommodations, such as payment of Order. interpreter services, and medical review Elaine L. Chao, e. DOL Agency Heads are delegated of reasonable accommodation requests; Secretary of Labor. authority and assigned responsibility for (4) Providing facilities for and bearing [FR Doc. 04–11869 Filed 5–25–04; 8:45 am] leadership in the implementation of the all costs related to a discrimination BILLING CODE 4510–23–P

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Part VIII

Department of Education Special Demonstration Programs—Model Demonstration Projects—Positive Psychology; Notice

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DEPARTMENT OF EDUCATION format (e.g., Braille, large print, application requirements, we invite audiotape, or computer diskette) on applications through a notice in the Federal RIN 1820–ZA35 request to the contact person listed Register. Special Demonstration Programs— under FOR FURTHER INFORMATION When inviting applications we Model Demonstration Projects— CONTACT. designate the priority as absolute, Positive Psychology SUPPLEMENTARY INFORMATION: competitive preference, or invitational. The effect of each type of priority AGENCY: Office of Special Education and Invitation To Comment follows: Rehabilitative Services, Department of We invite you to submit comments Absolute priority: Under an absolute Education. regarding this proposed priority, priority, we consider only applications ACTION: Notice of proposed priority, definitions, and application that meet the priority (34 CFR definitions, and application requirements. 75.105(c)(3)). requirements. We invite you to assist us in Competitive preference priority: Under a competitive preference priority, SUMMARY: The Assistant Secretary for complying with the specific we give competitive preference to an the Office of Special Education and requirements of Executive Order 12866 application by either (1) awarding Rehabilitative Services proposes a and its overall requirement of reducing additional points, depending on how priority, definitions, and application regulatory burden that might result from well or the extent to which the requirements under the Special this notice. Please let us know of any Demonstration Programs focusing on further opportunities we should take to application meets the competitive developing models that adapt positive reduce potential costs or increase priority (34 CFR 75.105(c)(2)(i)); or (2) psychology techniques for use by potential benefits while preserving the selecting an application that meets the vocational rehabilitation (VR) effective and efficient administration of competitive priority over an application professionals to improve the the program. of comparable merit that does not meet employment outcomes of VR During and after the comment period, the priority (34 CFR 75.105(c)(2)(ii)). consumers. The positive psychology you may inspect all public comments Invitational priority: Under an models developed under this priority about this proposed priority, invitational priority, we are particularly must incorporate effective, research- definitions, and application interested in applications that meet the based principles. The Assistant requirements between the hours of 8:30 invitational priority. However, we do Secretary may use this priority, a.m. and 4 p.m., eastern time, Monday not give an application that meets the definitions, and application through Friday of each week except invitational priority a competitive or requirements for competitions in fiscal Federal holidays. On or before June 4, absolute preference over other year (FY) 2004 and later years. We take 2004, you may inspect the comments in applications (34 CFR 75.105(c)(1)). this action to improve the quality of room 3038, 330 C Street, SW., Priority employment outcomes for VR Washington, DC. After June 4, 2004, you consumers through testing and may inspect the comments in room Proposed Priority, Definitions, and measuring the effects of three specific 5058, 550 12th Street, SW., Washington, Application Requirements—Model positive psychology techniques for use DC. Demonstration Projects—Positive Psychology within State VR agencies. Assistance to Individuals With DATES: We must receive your comments Disabilities in Reviewing the These model demonstration projects on or before June 25, 2004. Rulemaking Record would improve the quality of ADDRESSES: Address all comments about employment outcomes for VR this proposed priority, definitions, and On request, we will supply an consumers through testing and application requirements to Alfreda appropriate aid, such as a reader or measuring the effects of three specific Reeves, U.S. Department of Education, print magnifier, to an individual with a positive psychology techniques for use 400 Maryland Avenue, SW., room 3314, disability who needs assistance to within State VR agencies. Switzer Building, Washington, DC review the comments or other The program will be conducted under 20202–2645 (on or before June 4, 2004); documents in the public rulemaking section 303(b) of the Rehabilitation Act room 5040, Potomac Center Plaza, record for this proposed priority, of 1973, as amended (Act). The Washington, DC 20202–2645 (after June definitions, and application proposed priority supports section 4, 2004). If you prefer to send your requirements. If you want to schedule 303(b) by furthering the purposes of the comments through the Internet, use the an appointment for this type of aid, Act, specifically empowering consumers following address: please contact the person listed under of VR by implementing techniques that [email protected]. FOR FURTHER INFORMATION CONTACT. will increase the skills of individuals You must include the term ‘‘SPECIAL We will announce the final priority, with disabilities, enabling them to DEMONSTRATION: POSITIVE definitions, and application achieve high quality employment PSYCHOLOGY’’ in the subject line of requirements in a notice in the Federal outcomes. your electronic message. Register. We will determine the final Background FOR FURTHER INFORMATION CONTACT: priority, definitions, and application Alfreda Reeves. Telephone: (202) 205– requirements after considering Positive psychology is the study and 9361 (on or before June 4, 2004); (202) responses to this notice and other practice of counseling techniques based 245–7485 (after June 4, 2004); or via information available to the Department. on cognitive-behavioral therapy to assist Internet: [email protected]. This notice does not preclude us from individuals to develop an increased If you use a telecommunications proposing or funding additional awareness of their own positive device for the deaf (TDD), you may call priorities, subject to meeting applicable character strengths, emotional the Federal Information Relay Service rulemaking requirements. processing, and belief systems (FIRS) at 1–800–877–8339. Note: This notice does not solicit (Seligman & Csikszentmihalyi, 2000). Individuals with disabilities may applications. In any year in which we choose These techniques help consumers to obtain this document in an alternative to use this proposed priority, definitions, and build skills to accurately assess their

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internal beliefs that create barriers to three specific aspects of positive related to their work (Seligman, 2002). effectively cope with adversities that psychology and their application to Some individuals with disabilities may occur in their lives and to expand their rehabilitation—learned optimism; lack access or functional abilities to gain ability to challenge these beliefs in order strengths and virtues versus talents for some work-related talents, but they may to pursue flexible and appropriate employment; and subjective well-being. possess a variety of individual strengths responses to the adversities. Positive The learned optimism technique has and virtues. Identifying employment psychology techniques empower been demonstrated to be an effective settings based on individuals’ strengths individuals to take control of their own clinical therapeutic intervention in and virtues may result in a better match lives, to increase their capacity for numerous studies (Reivich & Shatte, for individuals to employment effective decisionmaking, and to persist 2002; Fredrickson, 2001; Sheldon & opportunities, higher productivity, and in pursuing goal-directed activities. King, 2001; Seligman & longer job retention. The principles of positive psychology Csikszentmihalyi, 2000; Vaillant, 2000; Positive psychology techniques have and the effectiveness of counseling Peterson & Seligman, 1984, for been linked to improved subjective techniques using these principles are example). Optimistic individuals have well-being (SWB) (Segerstrom, Taylor, well documented in the literature the skill to see setbacks as temporary Kemeny, & Fahey, 1998; Lucas, Diener (Reivich & Shatte, 2002; Fredrickson, and local, whereas pessimistic & Suh, 1996; Smith, Christensen, Peck, 2001; Sheldon & King, 2001; Seligman individuals see setbacks as permanent, & Ward, 1994; Mikulincer, 1989; & Csikszentmihalyi, 2000; Vaillant, pervasive, and personal. Pessimism Peterson, Luborsky, & Seligman, 1983). 2000; Peterson & Seligman, 1984). primarily undermines people by Individuals with high SWB take better Positive psychology factors have been lowering response initiation: Pessimistic care of themselves than do individuals demonstrated to affect the subjective people give up easily. with low SWB. experience of disability and the use of Research demonstrates that learned For example, the Surgeon General’s effective coping skills by individuals optimism results in less depression, report on smoking revealed that with a variety of physical and better productivity (including work optimists (those believing ‘‘what I do psychological conditions (Helgeson, productivity), and better overall health matters’’) gave up smoking at a higher Snyder, and Seltman, 2004; Brissette, (Helgeson, Snyder, & Seltman, 2004; rate than pessimists. Coping well with Leventhal & Leventhal, 2003; Riolli & Savicki, 2003; Brissette, a disability often requires compliance Fredrickson, B. L., et al., 2003; Symister Leventhal & Leventhal, 2003; Morris & with medical, physical, and & Friend, 2003; Penedo, et al., 2003; Long, 2002; Waldrop, et al., 2001; rehabilitation planning and activities. Chapin & Kewman, 2001; Waldrop, et Lyubomirsky, Tucker, Caldwell & Berg, For example, individuals in recovery al., 2001; Seligman & Csikszentmihalyi, 1999; Segerstrom, Taylor, Kemeny, & from many types of cardiac conditions 2000; Callahan, 2000). A review of the Fahey, 1998). are often recommended to make literature by the National Institute on The field of positive psychology has medication, dietary, and exercise Disability Rehabilitation Research demonstrated the effectiveness of changes in their lives. Research in (NIDRR) and use of the PsychArticles learned optimism principles and positive psychology has demonstrated research database revealed one reported techniques in changing pessimism to that individuals with low SWB fail to application of the principles of positive optimism, but these principles and follow these medical recommendations psychology to the employment techniques have not been applied to and, as a result, experience increased outcomes of individuals with individuals with disabilities in the levels of functional limitation more disabilities (Chapin & Kewin, 2001). public VR setting. often than individuals with high SWB. However, no research literature was Strengths and virtues versus talents Research in the field of positive identified that applied these principles for employment is a theoretical psychology has developed interventions and techniques to individuals with approach that has identified a paradox that produce improved SWB. disabilities in VR settings. about most work settings: Individuals To date, these three interventions Therefore, this proposed priority is are selected and educated for jobs based have not been used with individuals intended to develop and demonstrate on their talents, but much of their with disabilities in the VR setting to the validity of counseling tools and success, retention, and productivity at demonstrate their effect on high quality techniques based on the principles of work depends, not on talents, but on employment outcomes. positive psychology with individuals their strengths and virtues. Physical with disabilities in the VR system. coordination, analytic intelligence, and Priority Research in positive psychology has verbal fluency are examples of some of Under 34 CFR 75.105(b)(2)(v) and yielded a variety of approaches to assist the talents that result in obtaining jobs, section 303(b)(1) of the Rehabilitation individuals to identify their own beliefs but persistence, social intelligence, Act of 1973, as amended (Act), this and actions that are barriers to their kindness, humor, sense of purpose, and priority supports projects that test and ability to handle effectively life’s loyalty are some examples of the measure the effects of three specific adversities. These approaches are based strengths and virtues that have been positive psychology techniques for on the techniques of cognitive- identified as resulting in keeping jobs vocational rehabilitation (VR) behavioral skills development and (Seligman, 2002). professionals for improving the quality include models developed to change Methodology using the principles of of employment outcomes for rigid and pessimistic beliefs and positive psychology exists for assessing individuals with disabilities. The cognitive constructs to more flexible strengths and virtues as a means of models tested under this program must and positive ones. Major work in determining an individual’s incorporate effective, research-based developing positive psychology compatibility with a particular job. positive psychology methods. approaches has been reported by Martin Research has demonstrated that Seligman (1991), Barbara Fredrickson individuals who use their ‘‘signature A. Definitions (2001), Mihaly Csikszentmihalyi (1997), strengths’’ on the job have higher job Learned optimism teaches people to Reivich & Shatte (2002), and others. satisfaction, more loyalty, better become more hopeful, realistic, and Successful projects under this model productivity, are more engaged, and are flexible in their identification of and demonstration program would address more likely to have peak experiences disputation of internal beliefs that result

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in rigid, pessimistic, and negative Projects must investigate the definitions, and application outcome expectations. relationship between these strategies requirements. Strengths and virtues versus talents and meaningful postsecondary The benefit of this proposed priority, for employment is a theoretical concept education and employment outcomes; definitions, and application that links the internal characteristics of (5) Design and implement an requirements will be the establishment individuals rather than specific evaluation plan that— of model demonstration projects that functional skills or talents with (a) assesses the validity of the models will lead to improving the quality of employment success. tested and developed under this employment outcomes for VR customers Subjective well-being (SWB) is a program; through developing positive psychology measurement of an individual’s positive (b) includes use of objective techniques for use within State VR view of himself or herself across a performance measures that are clearly agencies. number of dimensions, including related to the intended outcomes and Intergovernmental Review optimism, life satisfaction, engagement, goals of the project and will produce health, and sense of purpose. quantitative and qualitative data to the This program is subject to Executive Order 12372 and the regulations in 34 B. General Requirements for Applicants extent possible; and (c) provides performance feedback CFR part 79. One of the objectives of the These model demonstration projects Executive order is to foster an must focus on research-based positive and permits periodic assessment of progress toward achieving intended intergovernmental partnership and a psychology principles that adapt strengthened federalism. The Executive appropriate techniques for VR outcomes and goals; and (6) Disseminate these strategies, as order relies on processes developed by professionals to use to assist VR State and local governments for consumers to obtain meaningful appropriate, to State VR agencies, their service providers, and independent coordination and review of proposed postsecondary education and Federal financial assistance. employment outcomes. The projects living centers funded by the Rehabilitation Services Administration This document provides early must test and measure the effects of notification of our specific plans and three specific techniques on achieving and other agencies and entities funded under the Act. actions for this program. meaningful postsecondary education Applicable Program Regulations: 34 and employment outcomes. The projects Executive Order 12866 CFR part 373. must measure outcomes associated with each required technique. An applicant This notice of proposed priority, Electronic Access to This Document definitions, and application must be specific about what data it will You may view this document, as well requirements has been reviewed in collect in order to measure project as all other Department of Education accordance with Executive Order 12866. outcomes against the established goals. documents published in the Federal Under the terms of the order, we have To meet the requirements an applicant Register, in text or Adobe Portable assessed the potential costs and benefits must— Document Format (PDF) on the Internet of this regulatory action. (1) Describe the manner in which at the following site: http://www.ed.gov/ The potential costs associated with positive psychology strategies will news/fedregister. the notice are those resulting from increase participation in postsecondary To use PDF you must have Adobe statutory requirements and those we education and employment outcomes Acrobat Reader, which is available free have determined as necessary for for consumers of the public VR program; at this site. If you have questions about administering this program effectively (2) Adapt, test, and measure the using PDF, call the U.S. Government and efficiently. impact of three positive psychology Printing Office (GPO), toll free, at 1– strategies on increasing the level of In assessing the potential costs and 888–293–6498; or in the Washington, optimism of consumers of the public VR benefits—both quantitative and DC, area at (202) 512–1530. program and investigate the relationship qualitative—of this notice, we have between learned optimism and determined that the benefits of the Note: The official version of this document proposed priority, definitions, and is the document published in the Federal consumers’ outcomes; Register. Free Internet access to the official (3) Adapt and develop positive application requirements justify the edition of the Federal Register and the Code psychology assessment tools to identify costs. of Federal Regulations is available on GPO the strengths and virtues of individuals We have also determined that this Access at: http://www.gpoaccess.gov/nara/ with disabilities, identify specific job regulatory action does not unduly index.html. environments that match specific interfere with State, local, and tribal strengths and virtues, pilot placement governments in the exercise of their (Catalog of Federal Domestic Assistance activities with individuals with governmental functions. Number 84.235A Special Demonstration disabilities based on the fit of their Programs—Model Demonstration Projects— Summary of Potential Costs and Positive Psychology) strengths and virtues, and investigate Benefits the relationship of consumers’ strengths Program Authority: 29 U.S.C. 773(b). and virtues and meaningful The Assistant Secretary has Dated: April 14, 2004. postsecondary education and determined that the cost to the Federal Troy R. Justesen, employment outcomes; Government associated with this Acting Deputy Assistant Secretary for Special (4) Develop positive psychology program will not exceed $300,000 in FY Education and Rehabilitative Services. strategies to enhance SWB of people 2004. No other costs will result from the [FR Doc. 04–11928 Filed 5–25–04; 8:45 am] with disabilities in the VR setting. announcement of this proposed priority, BILLING CODE 4000–01–P

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Part IX

Securities and Exchange Commission 17 CFR Parts 200, 230, 240, 242, and 249 Regulation NMS; Proposed Rule

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SECURITIES AND EXCHANGE please use only one method. The City.1 The NMS Hearing was composed COMMISSION Commission will post all comments on of a series of seven panels that the Commission’s Internet Web site collectively addressed each of the four 17 CFR Parts 200, 230, 240, 242, and (http://www.sec.gov/rules/ proposals. The panelists included a 249 proposed.shtml). Comments also are wide range of market participants who [Release No. 34–49749; File No. S7–10–04] available for public inspection and discussed the proposals themselves, as copying in the Commission’s Public well as their own initiatives intended, at RIN 3235–AJ18 Reference Room, 450 Fifth Street, NW., least in part, to respond to the Washington, DC 20549. All comments proposals. The Commission is extending Regulation NMS received will be posted without change; the comment period and publishing this AGENCY: Securities and Exchange we do not edit personal identifying supplemental request for comment to Commission. information from submissions. You give the public a fuller opportunity to ACTION: Proposed rule; extension of should submit only information that reflect the NMS Hearing in their 2 comment period and supplemental you wish to make available publicly. comments on the proposals. request for comment. FOR FURTHER INFORMATION CONTACT: A significant element of the NMS Daniel M. Gray, Attorney Fellow, at Hearing was the intention expressed by SUMMARY: The Securities and Exchange (202) 942–0159, or Heather Seidel, various representatives of exchanges Commission (‘‘Commission’’) is Attorney Fellow, at (202) 942–0788, with traditional trading floors to extending the comment period on rules Division of Market Regulation, establish facilities in the coming months proposed under Regulation NMS, which Securities and Exchange Commission, that will offer automatic execution of were published in Securities Exchange 450 Fifth Street, NW., Washington, DC orders seeking to interact with their Act Release No. 49325 (February 26, 20549–1001. displayed quotations (‘‘Auto-Ex 3 2004), 69 FR 11126 (March 9, 2004) SUPPLEMENTARY INFORMATION: Facilities’’). Panelists also emphasized (‘‘Proposing Release’’). The original that the essential element of an effective comment period would have expired on I. Introduction Auto-Ex Facility is an immediate May 24, 2004. The new comment period The Proposing Release published automated response (i.e., one without will expire on June 30, 2004. In Regulation NMS for public comment. In any manual intervention) to the router addition, the Commission is addition to redesignating the existing of the incoming order.4 They stated that supplementing its request for comment national market system (‘‘NMS’’) rules the response must be either that the on the proposed rules to reflect the adopted under Section 11A of the order was executed (in full or in part) hearing on Regulation NMS that was Securities Exchange Act of 1934 or that it could not be executed held on April 21, 2004 (‘‘NMS (‘‘Exchange Act’’), Regulation NMS (because, for example, a prior incoming Hearing’’). During the NMS Hearing, incorporated four substantive proposals order already had executed against the panelists discussed developments that that are designed to enhance and displayed quotation). The exchange bear on many significant issues raised modernize the regulatory structure of representatives acknowledged the by the proposed rules. The Commission the U.S. equity markets. First, the challenges posed by developing an is publishing this supplemental request Commission proposed a uniform rule efficient hybrid market—one that for comment and extending the for all NMS market centers that, subject integrates an active trading floor with an comment period to assure that the to two significant exceptions, would Auto-Ex Facility. They emphasized, public has a full opportunity to address require a market center to establish, however, that they were well advanced such issues in their comments. maintain, and enforce policies and in their efforts and indicated that such DATES: Comments should be received on procedures reasonably designed to facilities are likely to become or before June 30, 2004. prevent ‘‘trade-throughs’’—the operational within a time frame that ADDRESSES: Comments may be execution of an order in its market at a could precede any potential submitted by any of the following price that is inferior to a price displayed implementation date for Regulation methods: in another market (‘‘Trade-Through NMS, should the Commission decide to 5 Electronic comments: Proposal’’). Second, the Commission adopt the proposals. • Use the Commission’s Internet proposed a rule that would modernize In addition, panelists at the NMS comment form (http://www.sec.gov/ the terms of access to quotations and Hearing noted that existing order rules/proposed.shtml); or execution of orders in the NMS routing technologies were capable of • Send an e-mail to rule- (‘‘Access Proposal’’). The third proposal identifying, on a quote-by-quote basis, [email protected]. Please include File would prohibit market participants from indications from a market center that a Number S7–10–04 on the subject line; accepting, ranking, or displaying orders, particular quotation was not accessible or quotes, or indications of interest in a • Use the Federal eRulemaking Portal pricing increment finer than a penny, 1 A full transcript of the NMS Hearing (‘‘Hearing Tr.’’), as well as an archived video and audio (http://www.regulations.gov). Follow the except for securities with a share price webcast, is available on the Commission’s Internet instructions for submitting comments. of below $1.00 (‘‘Sub-Penny Quoting Web site (http://www.sec.gov). Paper comments: Proposal’’). Finally, the Commission 2 The discussion in this supplemental request for • Send paper comments in triplicate proposed amendments to the rules and comment assumes familiarity with the Proposing to Jonathan G. Katz, Secretary, joint industry plans for disseminating Release and therefore does not restate all of the specific terms of the proposals. In addition, the Securities and Exchange Commission, market information to the public that, Commission continues to request comment on all 450 Fifth Street, NW., Washington, DC among other things, would modify the of the matters set forth in the Proposing Release. 20549–0609. formulas for allocating plan revenues to 3 Hearing Tr. at 85, 90–92, 94–97, 120. All submissions should refer to File reward markets for more broadly based 4 Hearing Tr. at 32, 55–56, 65–66, 158. Number S7–10–04. This file number contributions to public price discovery 5 For each of the four substantive proposals under Regulation NMS, the Proposing Release requested should be included on the subject line (‘‘Market Data Proposal’’). comment on the appropriate phase-in period that if e-mail is used. To help us process and On April 21, 2004, the Commission would be needed to allow participants time to adapt review your comments more efficiently, held the NMS Hearing in New York to the proposed new regulatory environment.

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through an Auto-Ex Facility.6 The amount.7 Many panelists at the NMS quote-by-quote exception allow markets ability to display such a quotation Hearing agreed that the distinction more flexibility to provide investors a potentially would give exchanges with between an automated and non- choice as to a manual or automatic trading floors the flexibility to integrate automated market—a market that execution? Comment also is requested effectively the trading floor with an provides immediate access to its quotes on whether a quote-by-quote exception Auto-Ex Facility. Rather than being through automatic execution and one would create difficulties for routing classified as ‘‘fast’’ or ‘‘slow,’’ markets that does not—is important, and that systems that could not be easily would be allowed to offer choices to market participants should be able to managed. investors. In those particular contexts trade-through a manual market.8 The Commission requests comment as when a market’s quotation was not Panelists at the NMS Hearing, however, to the best way to effectuate a quote-by- accessible through an Auto-Ex Facility expressed the view that the distinction quote exception to the proposed trade- (for example, to provide an opportunity could, and perhaps should, be made through rule for manual quotes. for the floor to generate additional price between manual and automated quotes, Panelists at the NMS Hearing stated that discovery or price improvement), the rather than manual and automated it would be possible to attach an quotation would be identified as such markets.9 identifier to manual quotes in the and order-routers could respond The Commission therefore requests consolidated quote stream so that all accordingly. As discussed further further comment on the operation of the market participants would know the below, the Regulation NMS proposals proposed exception for manual markets. quote was a manual quote.12 The also could be drafted to reflect whether Specifically, the Commission requests Commission requests comment on the a quotation was, or was not, accessible comment as to whether the exception feasibility of this approach, and how it through an Auto-Ex Facility. from the proposed trade-through rule would work in practice. Should the Competitive forces and the needs of should apply to quotes that are not Commission explicitly require each investors, rather than regulatory immediately accessible through an market center, as part of its required classifications, would determine the Auto-Ex Facility (a manual or non- policies and procedures,13 to implement relative success of various types of automated quote), rather than providing a process to identify any non-automated manual and automated trading facilities. an overall exception for a manual bid or offer that it posts in the The near-term prospect that market.10 Would narrowing the scope of consolidated quote stream as manual? quotations displayed in the NMS may the proposed exception to manual Should the Commission require that the be predominantly accessible through quotes allow market centers and broker- NMS plans that govern the collection, Auto-Ex Facilities, but with some dealers to more efficiently execute consolidation and dissemination of flexibility for markets to offer investors orders across markets, while at the same quotes in NYSE, Amex and Nasdaq- the choice of manual trading, time preserving the protections of a listed stocks be amended to provide for potentially has very significant trade-through rule? By not forcing a this functionality with regard to the consequences for the rules proposed market center into a rigid quotes sent to the processors for those under Regulation NMS. Some of the classification—automated or manual, plans? 14 Should each self-regulatory most difficult issues raised by the would providing an exception for organization (‘‘SRO’’) be required, as proposals, particularly those relating to manual quotes, on a quote-by-quote part of its policies and procedures for trade-throughs, access, and market data, basis, provide more flexibility for complying with the proposed trade- derive from the problem of market centers with different market through rule, to impose a requirement accommodating both auto-executable structures to compete more fairly with on its members that they identify their and manual quotations within the NMS. each other? For instance, would bids and offers as manual when These problems could largely disappear narrowing the exception to manual submitting them to the SRO? in the near future if NMS quotes become quotes, which would allow a market Comment also is requested on predominately accessible through Auto- center with an Auto-Ex Facility to whether a market center should be able Ex Facilities. One of the primary display a manual quote in particular to decide on a security-by-security basis purposes of the supplemental request limited circumstances, provide more whether its quotes will be automated or for comment that follows is to flexibility for a market center with a manual. The Commission recognizes encourage the public to address the floor-based structure to effectively that an exception for manual quotes, as opportunities that such a development integrate its trading floor with an Auto- outlined above, would necessarily would offer for making substantial Ex Facility, if it so desired? 11 Would a provide market centers with this (and progress toward a more efficient NMS more) flexibility, by allowing them to for investors. 7 The Commission requested comment on all identify all quotes in a particular aspects of this proposed exception, including in security as manual quotes. If the II. Trade-Through Proposal particular how to define an automated market, and by what amount a market should be allowed to Commission adopted an exception to A. Exception for Manual Quotes trade-through a manual market. See Section III.D.2 the trade-through rule for manual The Proposing Release recognized of the Proposing Release. markets rather than manual quotes, 8 See, e.g., Hearing Tr. at 56–57, 63–67, 72, 75– however, should the exception that there are differences between the 76, 86, 132, 136, 142, 158. One panelist speed and certainty of response in characterized the distinction as between ‘‘maybe’’ explicitly allow a market to choose to be electronic (i.e. automated) versus and executable firm quotes. See Hearing Tr. at 52– manual (i.e. non-automated) markets. To 53, 55–57. towards a more automated system in any way they 9 see fit). provide flexibility to market centers Hearing Tr. at 57–58, 142–144, 157–158. 10 In Section III.B of this Release, the Commission 12 Hearing Tr. at 57, 142, 157–158. with different market structures, the requests further comment on whether or not there 13 See Section III.C.5 of the Proposing Release for Commission proposed an exception to should be trade-through protection for ‘‘high-fee’’ a discussion of the required policies and procedures the trade-through rule to allow an quotes. See also Section III.F of the Proposing that each order execution facility would be required automated market to trade-through a Release that requested comment on this issue as to establish, maintain and enforce pursuant to the well. proposed trade-through rule, proposed Rule 611 of non-automated market up to a certain 11 See Hearing Tr. at 57 (panelist expressing the Regulation NMS. view that focusing on automated quotes would 14 The NMS plans are described in Sections III.B.1 6 Hearing Tr. at 57, 142–144, 157–158. provide market centers with flexibility to evolve and VI.A of the Proposing Release.

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automated or manual on a security-by- NMS Hearing advocated imposing a market centers were providing an security basis? maximum response time, such as one immediate automated response in second or a quarter of a second.20 compliance with any performance 1. Definition of an ‘‘Automated’’ Quote The Commission requests further standards imposed? Several panelists at the NMS Hearing comment on whether it should impose One panelist at the NMS Hearing expressed the view that the concept of performance standards, such as no less expressed the view that a market center an ‘‘automated’’ market or quote must than one second, or a quarter of a posting a bid or offer should be required encompass an immediate automated second, or some other time frame, on to automatically update that quote, in response to the order router as to what the total time for a market center to order to be deemed an automated action was taken with respect to the respond to an order in an automated market.22 The Commission agrees that order.15 In other words, certainty as to manner, i.e., the time from when the providing an automatic update to the whether an order seeking to interact order is received by the executing best bid or offer is important because with a displayed quote can immediately market center to the time that the market participants other than the interact with such quote—knowing executing market center sends a report participant whose order executed instantaneously whether an order was back to the order router indicating the against the quote need to know whether executed (in full or in part) or action taken with respect to the order. a particular quote is still available or cancelled—is key. Would imposing a performance not. Not updating a quote to In the Proposing Release, the standard alleviate concern that, because immediately reflect the true status of the Commission proposed to define an each market otherwise would be able to quote inhibits full transparency and ‘‘automated order execution facility’’ as determine what ‘‘immediate’’ means could lead to uncertainty as to whether a order execution facility that provides with respect to its own bids and offers, the market center’s quotes are indeed for an immediate automated response to a market participant might be required immediately accessible through an all incoming orders for up to the full to access a better price on a market Auto-Ex Facility. The Commission size of its best bid and offer center that it did not believe provided therefore requests comment on whether, disseminated pursuant to an effective an immediate response? Would market in order for a market center or quote to national market system plan, without centers continue to have an incentive to be considered automated, the market 16 any restrictions on executions. The compete on the basis of execution speed center posting the quote should be Commission requests comment on if a performance standard were required to provide for an automated whether it should make explicit in the imposed? 21 The Commission also update to the quote it is executed proposed definition of an automated requests comment on whether there is a against. The Commission also requests market or automated quote that need to impose a response time of less comment on whether it should impose providing an immediate automated than one second. Specifically, would a performance standard, such as one response would include immediately investors benefit significantly, or at all, second, on the time within which the sending a report back to the market from sub-second response times? If so, order execution facility would be center that submitted the order, either how would they benefit? Additionally, required to update its automated quote. reporting an execution or cancellation. would it be necessary or advisable to Finally, comment is requested on In addition, should the Commission impose sub-second response times in whether the Commission should require make explicit that the automated market order to promote a smoothly operating market centers to provide an automatic or quote must provide an automatic marketplace? cancellation functionality that would execution functionality for the whole The Commission requests comment allow a market participant that has put order or provide an automatic with regard to surveiling for and a limit order on the market center’s limit cancellation for the remaining portion of enforcing compliance with a order book to automatically cancel the an order not executed against the quote? performance standard. In particular, the limit order. If so, should the The Commission also requested Commission requests comment on Commission require that cancellations comment in the Proposing Release as to whether, if it were to adopt a be honored within a certain time frame, whether it should provide specific performance standard, it should require such as less than one second? guidance with regard to what that each market center publicly 2. Allowable Trade-Through Amount ‘‘immediate’’ would mean in terms of disclose the percentage of time, or each 17 providing an automated response. actual instance, that it did not provide In the Proposing Release, the Panelists believed that, at a minimum, a response in compliance with the Commission requested comment on the for a quote to be considered automated standards required by the rule. Would amount by which a market should be there must be no manual or human requiring public disclosure provide an allowed to trade through a manual 23 intervention involved in responding to added incentive for market centers to market. Panelists at the NMS Hearing an order seeking to interact with that continue to improve their technology expressed the view that a market center 18 quote. In the Proposing Release, the and the services they provide? Would it should be allowed to trade-through a Commission requested comment as to allow market participants and the manual market by an unlimited 24 whether it would be appropriate to Commission to better determine if the amount. One panelist stated that the impose a performance standard with quotes of a market center that the ability to trade-through a manual market 19 respect to response times. The market center determine to be has to be ‘‘unfettered’’ because of a Commission notes that panelists at the automated are indeed automated in concern with the practicality of compliance with the proposed complying with the proposed tiered 15 See, e.g., Hearing Tr. at 54–57, 65–66, 133, 158. standards? Is there any other approach (which would look to the 16 See Section III.D.2.a of the Proposing Release mechanism by which market NBBO of the security at the time of and paragraph (b)(3) of proposed Rule 600 of execution for purposes of determining Regulation NMS. The Commission requested participants could determine whether detailed comment on this proposed definition. See the allowable trade-through amount)

Section III.D.2 of the Proposing Release. 20 See Hearing Tr. 59 and 86 (advocating a 1⁄4 of 17 See Section III.D.2.a of the Proposing Release. a second, at least 98% of the time), 62 (advocating 22 Hearing Tr. at 14. 18 See Hearing Tr. at 29, 32, 55–56, 59. that a fast market is under one second). 23 See Section III.D.2.c of the Proposing Release. 19 See Section III.D.2.a of the Proposing Release. 21 See Hearing Tr. at 25–28. 24 Hearing Tr. at 57–58, 67.

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given the incidence of flickering prices disclose how often it provided an paragraph (b)(7) of Rule 611 of in today’s market.25 The Commission immediate automated response within Regulation NMS would provide an requests further comment as to the certain time frames or within the exception for those instances where an amount by which a market should be performance standards? order execution facility sends an order allowed to trade through a manual Another potential use of the opt-out to execute against a better-priced order quote. Specifically, the Commission exception could be to by-pass displayed on another market at the same requests comment as to whether there quotations likely to be unavailable due time or prior to executing an order in its should be no limit. As emphasized in to prior execution. Such a use could own market at an inferior price.33 The the Proposing Release, however, such an arise, for example, when a quotation Commission recognizes, however, that a exception to the trade-through rule suddenly becomes attractive to many market center that receives one part of would in no way alter or lessen a traders at the same time (e.g., because of an ‘‘intermarket sweep order’’ would broker-dealer’s duty to achieve best a price change in a related security). not know that other ‘‘sweep’’ order(s) execution.26 One can conceive of circumstances in have been sent to other market centers which a large, and perhaps rapidly to attempt to execute against any better- B. Opt-Out Exception growing, number of orders pursues a priced bids or offers displayed on those Panelists were split about the need for small and rapidly changing number of markets, unless the order(s) were an opt-out exception. Some panelists at quotations. The Commission would be identified in some manner. Thus, the the NMS Hearing expressed the view concerned if such scenarios could receiving market could, pursuant to the that there would be no need, or valid severely impact individual market proposed trade-through rule, route the policy reason, to allow a market to trade centers or even interfere with the order it received to another market through an automated market or smooth functioning of the marketplace. displaying a better price, even though automated quote of another market.27 In The Commission requests comment on the order router already has attempted addition, representatives of two floor- whether such scenarios are likely, what to take out those better prices. based exchanges have publicly their potential impact might be, and Therefore, the Commission is requesting expressed the intent to take the whether a specific exception to the comment as to how each order sent by necessary steps to become automated for trade-through rule is needed to provide a market participant in compliance with purposes of the proposed exception to market participants with acceptable a ‘‘sweep order’’ exception should be the trade-through rule.28 Thus, the means to execute their orders under identified so that the receiving market Commission requests comment as to such conditions. If commenters believe center would be able to execute the whether, if it were to adopt an exception an exception is needed, the Commission order without regard to whether a better to the trade-through rule for manual requests information on the nature of price were displayed on another market quotes, the proposed opt-out exception the requirement and the form that such center. would still be necessary or desirable. an exception might take. The D. Type of Securities Subject to the Other panelists supported an opt-out Commission requests comment on 29 Proposed Rule exception. Several panelists at the whether an opt-out exception would be NMS Hearing stated that one benefit of needed for customers of order execution Some panelists at the NMS Hearing the proposed opt-out exception is that it facilities that do not currently interact questioned the need for a trade-through could create market pressure that would with other exchanges or order execution rule and argued against extending the discipline markets that provided slow facilities. trade-through rule to the Nasdaq market. executions or inadequate access to their Given the prospect of greater markets.30 The Commission requests C. Other Exceptions automation of execution facilities comment on this issue. Would there be The Commission also is requesting discussed at the NMS Hearing, the less of a need for the opt-out as a further comment as to whether there are Commission requests comment on how mechanism for market discipline if the particular types of transactions the such a development would affect the Commission were to adopt explicit execution of which should be excepted need for a trade-through rule in the performance standards with regard to from the proposed trade-through rule market for listed securities. In this defining what an ‘‘immediate’’ that are not covered by the proposed connection, the Commission also automated response means under an exceptions, consistent with the reiterates its request for comment on the exception for manual quotes? fundamental policies of price priority.31 need to expand the trade-through rule to If commenters believe that an For example, should there be an the Nasdaq market. additional mechanism is needed to exert exception provided for basket or III. Access Proposal market pressure on market centers, what program trades that are executed at a type of mechanism would be effective single price distinct from current prices The Access Proposal includes three but still support the underlying goals of for each of the securities contained in primary parts: standards for market price protection and best execution? For the basket? In addition, should an access, limitations on access fees, and instance, as discussed above in Section exception be provided for an standards to address locked or crossed II.A.1, whether or not the Commission ‘‘intermarket sweep order’’ by which a quotations. An overview of the Access adopted a performance standard with market participant can simultaneously Proposal is set forth below to promote regard to an exception for a manual route orders to interact with all best bids greater understanding of its details and market or quote, should the Commission and offers displayed in the consolidated to assist commenters in formulating require each market center to publicly quote system? 32 As proposed, their views. Next, additional comment is requested on the potential alternatives 25 Hearing Tr. at 67. See Section III.D.2.c of the 31 See Section III.D of the Proposing Release for Proposing Release for a detailed description of the a discussion of the proposed exceptions to the its own market at an inferior price, or a market proposed allowable trade-through amounts. trade-through rule. participant could wish to execute the entirety of an 26 Section III.C.7 of the Proposing Release. 32 An ‘‘intermarket sweep order’’ could arise order it holds by sending orders to interact with the 27 Hearing Tr. at 32, 58, 65, 74, 80, 84, 85, 154. where a market center wants to be able to route an best bids and offers displayed on other market 28 Hearing Tr. at 85, 88, 90–92, 94–95, 97, 116. order(s) to execute against any better-priced bid(s) centers. See Hearing Tr. at 53–54, 145–146. 29 Hearing Tr. at 14–15, 18, 19, 36. or offer(s) on other market center(s) at the same time 33 See Section III.D.3 and note 82 of the Proposing 30 Hearing Tr. at 28, 35–36, 43. as or prior to executing the remaining balance in Release.

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for other aspects of Regulation NMS if through any SRO order execution limit to no more than $0.002 per share access fees are not limited to a de facility. Second, the trading threshold in any transaction the accumulated minimis amount. that triggers the fair access standards of access fees that could be charged by any Rule 301(b)(5) of Regulation ATS would SRO order execution facility, QMP, or A. Overview of Access Proposal be lowered from 20% to 5% of the other broker-dealer to any person, 1. Market Access Standards average daily volume in a security.36 including subscribers, members, or 39 Paragraph (a) of proposed Rule 610 When subject to such fair access other market centers. This de minimis under Regulation NMS would establish standards, an ATS is prohibited from standard is designed to promote a access standards for two types of market unreasonably limiting any person from common quoting convention and to centers, which between the two would obtaining access to the ATS’s services, facilitate the ready comparison of encompass all quotations that are such as by becoming a direct subscriber quotations across the NMS. disseminated to the public through the of the ATS.37 Application of the proposed fee consolidated data stream. First, an SRO The Commission continues to request limitations to different types of entities order execution facility (defined in comment on all of the issues relating to would vary depending on how a proposed Rule 600(b)(61) as a ‘‘quoting standards of direct and indirect access quotation were accessed by an order market center’’) would be prohibited that were raised in the Proposing router. Such access could be divided from imposing unfairly discriminatory Release. In addition, panelists at the into three categories. First, quotations could be accessed terms that inhibit a non-member, non- NMS Hearing indicated that access through an SRO order execution facility. customer, or non-subscriber from could remain a problem at relatively Under paragraph (b)(1) of proposed Rule obtaining access to quotations and the inactive ATSs or market makers with 610, the SRO order execution facility execution of orders through a member, little trading volume whose quotations would be authorized to charge a fee of customer, or subscriber.34 Second, any were displayed only in the ADF (and no more than $0.001 per share. In broker-dealer whose quotations are not therefore fell within the proposed 38 addition, if the quote were attributable available for execution through any SRO definition of a QMP). Market to a particular broker-dealer, the broker- order execution facility (such a broker- participants could obtain access to such dealer also would be authorized to dealer would be defined in proposed quotations only through direct charge a fee of no more than $0.001 per Rule 600(b)(62) as a ‘‘quoting market connections with the particular ATS or share under paragraph (b)(3) of participant’’ (‘‘QMP’’)) 35 also would be market maker. Panelists suggested that proposed Rule 610. The purpose of the prohibited from imposing unfairly such an entity should be required to ‘‘attributable’’ requirement is to enable discriminatory terms that inhibited a publish its quotations in an SRO order an order router to know in advance non-member, non-customer, or non- execution facility, at least until its share whether an additional broker-dealer fee subscriber from obtaining access to of trading reached a point where the would be charged when a quotation is quotations or the execution of orders cost of direct connections with multiple accessed through an SRO order through a member, customer, or market participants would not be out of execution facility.40 The quotation subscriber. This standard is intended to proportion to the entity’s level of therefore would not need to be assure that all parties have effective trading. Comment is requested on this explicitly attributed to a broker-dealer indirect access through members and issue. Alternatively, SROs without an individually in the consolidated data subscribers to quotations displayed by order execution facility could be stream. Instead, the ‘‘attributable’’ SRO order execution facilities and required to ensure that any potential requirement would be satisfied if an QMPs, thereby obviating the necessity QMP is directly connected to most SRO effectively and publicly identified for direct, intermarket linkages between market participants, before publishing the broker-dealer responsible for a market centers such as the Intermarket that QMP’s quotations. Finally, quotation. For example, a quotation Trading System (‘‘ITS’’). comment is requested in general on In addition, the Access Proposal whether market participants currently would be attributable if the SRO would address direct access to markets have effective and efficient access to identified a single specialist responsible in two contexts. First, paragraph (a)(2)(i) SRO order execution facilities and for all quotations in a given security, or of proposed Rule 610 would require a QMPs and whether this access provides 39 The term ‘‘access fee’’ as used in proposed Rule QMP to provide access to its quotations a sound basis for the proposed 610 would include any fee charged by an SRO order to allow SRO order execution facilities regulatory approach. execution facility, QMP, or broker-dealer that is and other QMPs to route orders for based on the execution of orders against its execution to the QMP on terms as 2. Limitations on Access Fees displayed quotations. It therefore encompasses both Paragraph (b) of proposed Rule 610 the specific fees charged by ATSs to non- favorable as those that the QMP grants subscribers for access to their quotations, as well as to its most preferred member, customer, would establish a de minimis standard any other fees charged by SROs and ATSs to their or subscriber. This additional for access fees. The fee limitation with members and subscribers that are based on the requirement is necessary because a the broadest scope is set forth in execution of orders against their displayed proposed paragraph (b)(4), which would quotations. Comment is requested on the definition QMP’s quotes would not, by definition, of access fees. Should it be broadened to include be otherwise available for execution order cancellation fees, fees for capacity usage, or 36 17 CFR 242.301(b)(5). any fee charged by the market center specific to a 34 The phrase ‘‘access to quotations and execution 37 The fair access standards of paragraph (b)(5) of transaction? of orders’’ would encompass access both to a Rule 301 of Regulation ATS do not require ATSs 40 Comment is requested on whether this policy market’s best bid and offer and to quotations to provide indirect access to non-subscribers to objective to give advance notice could be achieved included in a market’s ‘‘depth of book.’’ such services as displaying limit orders, use of with respect to non-attributable quotes (for 35 Currently, the only broker-dealers that would special handling orders, or proprietary market data. example, if the SRO specified the fee that could be fall within the proposed definition of a QMP are Paragraph (b)(3) of Rule 301 addresses the charged by broker-dealers who displayed non- ATSs or market makers whose quotations are ‘‘execution access’’ required to an ATS’s best bid attributable quotes through the SRO’s order displayed in the consolidated data stream solely and offer that is provided to an SRO for inclusion execution facility). Comment also is requested on through the Alternative Display Facility (‘‘ADF’’) in the consolidated data stream. It requires an ATS alternatives other than an attribution requirement operated by the NASD. If a broker-dealer makes its to provide execution access that is equivalent to the for achieving the objective of notifying order-routers quotations available for execution through any SRO access provided to other quotations displayed that an additional broker-dealer fee would be order execution facility, it would not fall within the through such SRO. charged for accessing a quotation through an SRO proposed definition of a QMP. 38 Hearing Tr. at 135, 138–139. order execution facility.

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if the SRO disseminated a proprietary In contrast to ATSs, market makers Comment also is requested on whether public data stream identifying the currently are not permitted to charge a the Commission should simply adopt a broker-dealer responsible for a fee for access to their quotes under single accumulated fee limitation, such particular quotation. Exchange Act Rule 11Ac1–1(c)(2) (the as the one set forth in paragraph (b)(4) Second, quotations could be accessed ‘‘Quote Rule’’) (proposed to be that would apply to all types of market through a QMP (i.e., an ATS or market redesignated as Rule 602 under centers. If a single accumulated fee maker whose quotes were displayed in Regulation NMS). If adopted, Rule limitation were adopted, would $0.002 the ADF and were not accessible 610(b)(3) would affirmatively authorize per share be an appropriate amount, or through any SRO order execution a market maker to charge a fee of no should it be higher or lower? Comment facility). This type of entity would be more than $0.001 per share only in the also is requested on whether fee authorized to charge a fee of no more specific context of when an attributable limitations should apply to undisplayed than $0.001 per share. quote were accessed through an SRO orders at prices better than the best Third, quotes could be accessed order execution facility. Outside of this displayed quote, reserve size at the directly through a broker-dealer who context, however, existing rules would displayed quote, or quotes displayed or was not a QMP because its quotes also continue to apply and market makers available at prices inferior to the were accessible through an SRO order would not be authorized to charge a fee displayed quote. Are these limitations execution facility. Except for the for direct access to their quotes. Unlike needed to avoid discouraging the accumulated fee limitation of $0.002 per ATSs, market makers are not subject to display of quotes? Further, would share set forth in paragraph (b)(4) of the additional access requirements limiting access fees discourage the proposed Rule 610, this type of direct imposed by Regulation ATS. display of quotes? For each of the fee limitations in access to a non-QMP broker-dealer’s proposed Rule 610(b), the scope of 3. Locked or Crossed Quotations quotes is not specifically covered by the quotations covered by the limitation Paragraph (c) of proposed Rule 610 proposal. Consequently, the fees for this should be interpreted in conjunction sets forth standards addressing locked type of access to quotations would with the definitions in proposed Rule or crossed quotations. It would require continue to be governed by existing 600(b)(61) and (62) of a ‘‘quoting market every SRO to establish and enforce rules rules, which vary depending on whether center’’ and a ‘‘quoting market that require its members to avoid the broker-dealer is an ATS or a market participant.’’ The definitions would locking or crossing quotations, that are maker. encompass, respectively, an SRO order reasonably designed to enable market Under this third type of access, ATSs, execution facility that made its best bid participants to reconcile locked or which are subject to the access and offer available pursuant to the crossed quotations, and that prohibit its standards of Regulation ATS, would Quote Rule, and a broker-dealer that members from engaging in a pattern or continue to be allowed to charge a fee provided its best bid and offer to an practice of locking or crossing for access to their quotations, subject to SRO pursuant the Quote Rule or quotations. the accumulated fee limitation of $0.002 Regulation ATS. The scope of the fee As discussed above, panelists at the per share. Although ATSs would not be limitations in proposed Rule 610(b) NMS Hearing suggested that quotations explicitly limited to a fee of $0.001, as would be limited to these best bids and not accessible through an Auto-Ex are SRO order execution facilities, offers, all of which are disseminated to Facility should be identified as such in competitive factors likely would the public through the consolidated data the consolidated data stream. Comment preclude ATSs from being able to retain stream. Such bids and offers would be is requested on whether market more than $0.001 of the maximum eligible for trade-through protection participants submitting quotations that $0.002 fee. Broker-dealers with under the proposed trade-through rule. are automatically executable should be displayable orders would know that These bids and offers also are eligible to allowed to lock or cross quotations that they could submit such orders directly be designated as national best bids and are identified as not being automatically to an SRO order execution facility and offers (‘‘NBBOs) and therefore could executable.43 charge a fee of $0.001.41 Consequently, have significant implications for B. Alternatives to Access Fee they would be unlikely to submit their purposes of a broker-dealer’s duty of Limitations orders to an ATS if the ATS does not best execution. The proposed fee agree to pay a rebate of at least $0.001 limitations would help assure that all The Proposing Release requested to match what the broker-dealer could order routers had efficient access to the comment on how other aspects of obtain through an SRO order execution quotations necessary to fulfill their proposed Regulation NMS would be facility. If the ATS charged the regulatory responsibilities. The fee affected if the Commission ultimately maximum $0.002 fee, this would leave limitations would not, however, cover determined not to limit access fees to a the ATS with only $0.001 after the quotations included in a market’s depth de minimis amount. In the discussion of rebate to the broker-dealer—the same of book. Accessing depth of book is the Trade-Through Proposal, for fee that an SRO order execution facility more subject to the choice of order example, comment was requested on would be authorized to charge under routers than accessing best bids and whether, if fees were not limited, paragraph (b)(1) of proposed Rule 610. offers. Also, order routers can avoid quotations with fees of greater than a de interacting with a market’s depth of minimis amount should be excluded 41 If, however, the broker-dealer with a book by submitting an order with a limit from protection under the proposed displayable order wished to retain anonymity, it price at the best bid or offer.42 trade-through rule.44 In addition, the could not charge a fee for an execution through an Comment is requested on the discussion of the Market Data Proposal SRO order execution facility because the quote noted the close connection between the would not be attributable. In contrast, the broker- structure of the various fee limitations dealer could retain its anonymity by placing the set forth in proposed Rule 610(b). order with an ATS. Comment is requested in note 43 As discussed below, the Commission also is 42 above on possible alternatives to the attribution 42 The fee limitations would apply to any order requesting comment on the issue of whether, if the requirement, which could eliminate the difference execution at the displayed price of the best bid or proposed fee limitations are not adopted, markets in treatment between access to quotations through offer. They therefore would encompass executions with de minimis fees should be allowed to display SRO order execution facilities and direct access against both the displayed size and the reserve size quotations that lock quotations with high fees. through ATSs. of a quotation. 44 Section III.F of the Proposing Release.

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issue of limiting access fees and market data.47 For example, a quotes at the NBBO, would include an allocating market data revenues based representative of Nasdaq stated that it automatic cut-off when quotes that are on a market’s quotations. Comment was recently had examined its costs and not fully accessible through automatic requested on whether, if fees were not concluded that, instead of the current execution are left alone at the NBBO. limited, quotations with greater than de $20 monthly fee for professional The purpose of the automatic cutoff for minimis fees should be excluded from investors to obtain basic data—NBBO manual quotes was to minimize the an allocation of market data revenues.45 and trades—in Nasdaq-listed stocks, the reward for quotes that could be stale if The Commission renews its request number should be approximately $5 to in the process of being manually for comment on whether it should or $7 per month.48 He did not discuss, updated. The Commission requests should not adopt any access fee however, the costs incurred by Nasdaq comment on whether only quotes that limitation and, if it does not adopt a fee to produce the full quotation data are accessible through an Auto-Ex limitation, on alternative measures that (‘‘Level II data’’) that is disseminated by Facility should be considered in the potentially could be adopted. In Network C. Another panelist stated that allocation of market data revenues, particular, should quotations with high the Networks should be required to thereby eliminating any need for the fees be treated differently than disclose publicly the actual cost of formula to include an automatic cutoff quotations with de minimis fees for providing market data to the public.49 applicable to manual quotes.53 purposes of the other proposals? The The Commission would welcome public Second, comment is requested on differing treatment could reflect the fact comment addressing the reasonableness whether, if manual quotes were that, for example, a $10.00 quotation of market data fees and whether the excluded from the calculation of with a high fee is not equal to $10.00 Commission should modify its approach Quoting Shares, the proposed additional quotation with a de minimis fee. to reviewing such fees. As noted in the measure of quoting activity—the Quotations with fees of more than a de Proposing Release, one of the proposed NBBO Improvement Share— minimis amount could be identified as Commission’s primary goals with should be eliminated from the formula. such in the consolidated data stream, respect to market data is to assure The NBBO Improvement Share is analogous to the identification of reasonable fees that promote the wide significantly more complex than the quotations not accessible through an public availability of market other aspects of the formula, which 50 Auto-Ex Facility that was discussed information. Indeed, an extensive essentially are calculated already by above. Such high-fee quotations could public record has been developed on those who track the trading and quoting be excluded from protection under the this issue over the last five years. This activity of market centers. The NBBO trade-through rule, eliminated from the record includes the Commission’s 1999 Improvement Share was designed allocation of market data revenues, and concept release on market information primarily to single out and reward price subject to locking quotations from fees and revenues (‘‘Concept leaders—those market centers that quote 51 most aggressively by frequently market centers with de minimis fees.46 Release’’), the public comments displaying better prices and thereby Comment is requested on the received in response to the Concept helping to narrow quoted spreads. An advisability of these alternatives, as Release, and the 2001 report of the additional measure of quoting activity compared with adopting a limitation on Commission’s Advisory Committee on was particularly important to offset the access fees. Market Information (‘‘Advisory Committee’’).52 In formulating their advantage that manual quotes could IV. Market Data Proposal comments on these matters, commenters have in the calculation of Quoting Shares. Such manual quotes might At the NMS Hearing, the market data are encouraged to consider and respond merely match the prices set by other panelists focused primarily on two to the views reflected in the public markets, yet not be accessed quickly issues—the level of market data fees and record. because not automatically executable. the complexity of the proposed formula B. Revenue Allocation Formula As a result, manual quotes would tend for allocating market data revenues to At the NMS Hearing, some panelists to equal the NBBO for long periods of the SROs. The Commission wishes to questioned the complexity and cost of time merely because they were the least request additional comment on these the proposed formula for allocating accessible quotes available at the price. issues. market data revenues to the SROs. The If manual quotes were excluded from A. Market Data Fees Commission wishes to request the calculation of Quoting Shares, the supplemental comment on this issue. need for an additional quoting measure Several panelists at the NMS Hearing First, the prospect that, in the future, would be somewhat diminished. addressed the current level of fees displayed quotes for NMS stocks may be Comment is requested on whether the charged by the market data Networks predominantly accessible through Auto- benefit of rewarding aggressive quote and questioned whether such fees Ex Facilities presents an opportunity for improvement justifies the increased remain reasonably related to the cost of simplifying the proposed formula. As complexity of calculating the NBBO proposed, the calculation of an SRO’s Improvement Share. 45 Section VI.C.2 and note 289 of the Proposing Quoting Share, which would reward Finally, although the Proposing Release. The Proposing Release also noted that markets for the time and size of their quotations displayed in the consolidated data Release itself recognized that the stream often may be locked because one or both proposed formula is relatively complex, quotes may have a fee attached. Comment was 47 See, e.g., Hearing Tr. at 223–224, 228–229, the difficulty and cost of implementing requested on whether limiting fees to a de minimis 230–231. 48 the formula may have been overstated at amount would help address this problem. Section Hearing Tr. at 223–224. the NMS Hearing. No additional data is IV.B.4 of the Proposing Release. 49 Hearing Tr. at 230. 46 In Section IV.B.4 of the Proposing Release, the 50 Section VI.B of the Proposing Release. necessary to calculate the formula Commission requested comment on whether there 51 Securities Exchange Act Release No. 42208 beyond the quote and trade data that should be an exception from the locked quotation (December 9, 1999), 64 FR 70613 (December. 17, provisions of proposed Rule 610(c) for quotations 1999). 53 Comment was requested in section III.B above of automated markets that lock quotations that are 52 Report of the Advisory Committee on Market on whether, if access fees are not limited, quotes only manually accessible. A similar exception Information: A Blueprint for Responsible Change with fees of greater than a de minimis amount could be made for quotations of de minimis fee (September 14, 2001) (available at http:// should be excluded from the allocation of market markets that lock quotations with high fees. www.sec.gov). data revenue.

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already is disseminated by the Network three Networks to program and process comment on the Regulation NMS processors and stored by data vendors. the calculations required by the proposals that were published in the The formula would not need to be proposed formula, thereby potentially Proposing Release. It particularly calculated in real-time, nor would reducing the implementation costs by a encourages the public to consider the anyone other than the Network significant amount. Comment is significant matters discussed during the processors and other industry requested on the potential NMS Hearing when formulating their participants need to deal with the implementation costs of the proposed comments. formula directly. Consequently, it does formula and on possible ways to Dated: May 20, 2004. not appear that adoption of the formula minimize such costs. By the Commission. would impose any additional V. General Request For Comment Margaret H. McFarland, ‘‘downstream’’ systems costs on vendors In addition to the supplemental Deputy Secretary. or broker-dealers. Indeed, if necessary, a requests for comment set forth above, [FR Doc. 04–11879 Filed 5–25–04; 8:45 am] single vendor could be retained by all the Commission renews its requests for BILLING CODE 8010–01–P

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Reader Aids Federal Register Vol. 69, No. 102 Wednesday, May 26, 2004

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING MAY

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 2 CFR 21, 2004 ...... 24905 No. 2004–30 of April Executive orders and proclamations 741–6000 Subtitle A ...... 26276 21, 2004 ...... 24907 The United States Government Manual 741–6000 Subtitle B ...... 26276 5 CFR Other Services 215...... 26281 Electronic and on-line services (voice) 741–6020 3 CFR 532...... 26475 Privacy Act Compilation 741–6064 550...... 26475 Proclamations: 595...... 27817 Public Laws Update Service (numbers, dates, etc.) 741–6043 7776...... 25283 1650...... 29849 741–6086 TTY for the deaf-and-hard-of-hearing 7777...... 25285 1653...... 29849 7778...... 25287 1655...... 29849 ELECTRONIC RESEARCH 7779...... 25289 1690...... 29849 World Wide Web 7780...... 25291 7781...... 26467 7 CFR Full text of the daily Federal Register, CFR and other publications 7782...... 26469 is located at: http://www.gpoaccess.gov/nara/index.html 1...... 28041 7783...... 26471 6...... 27818 Federal Register information and research tools, including Public 7784...... 26473 51...... 29171 Inspection List, indexes, and links to GPO Access are located at: 7785...... 29031 301 ...... 24909, 25303, 27821 http://www.archives.gov/federallregister/ 7786...... 29033 319...... 24916 E-mail 7787...... 29035 800...... 26476 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 7788...... 29037 932...... 29171 an open e-mail service that provides subscribers with a digital 7789...... 29845 1410...... 26755 form of the Federal Register Table of Contents. The digital form 7790...... 29847 1415...... 29173 of the Federal Register Table of Contents includes HTML and Executive Orders: Proposed Rules: PDF links to the full text of each document. 10485 (See EO 301...... 29466 13337) ...... 25299 319...... 29466 To join or leave, go to http://listserv.access.gpo.gov and select 10530 (See EO 457...... 27864 Online mailing list archives, FEDREGTOC-L, Join or leave the list 13337) ...... 25299 762...... 24537 (orchange settings); then follow the instructions. 11023 (Amended By 958...... 29244 PENS (Public Law Electronic Notification Service) is an e-mail EO 13341)...... 29843 989...... 29672 service that notifies subscribers of recently enacted laws. 11423 (Amended By 1150...... 29907 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html EO 13337)...... 25299 1160...... 29907 and select Join or leave the list (or change settings); then follow 13047 (See Notice of 1205...... 29907 the instructions. May 17, 2004)...... 29041 1207...... 29907 13096 (Revoked By 1209...... 29907 FEDREGTOC-L and PENS are mailing lists only. We cannot EO 13336)...... 25299 1210...... 29907 respond to specific inquiries. 13175 (See EO 1215...... 29907 Reference questions. Send questions and comments about the 13336) ...... 25299 1216...... 29907 Federal Register system to: [email protected] 13212 (See EO 1218...... 29907 The Federal Register staff cannot interpret specific documents or 13337) ...... 25299 1219...... 29907 regulations. 13224 (See EO 1220...... 29907 13338) ...... 26751 1230...... 29907 13303 (See Notice of 1240...... 29907 FEDERAL REGISTER PAGES AND DATE, MAY May 20, 2004)...... 29409 1250...... 29907 24063–24504...... 3 13310 (See Notice of 1260...... 29907 24505–24904...... 4 May 17, 2004)...... 29041 1280...... 29907 24905–25302...... 5 13315 (See Notice of 1739...... 26777 25303–25478...... 6 May 20, 2004)...... 29409 1770...... 25848 13336...... 25299 25479–25816...... 7 13337...... 25299 9 CFR 25817–25996...... 10 13338...... 26751 53...... 27823 25997–26298...... 11 13339...... 28037 71...... 27823 26299–26472...... 12 13340...... 29043 92...... 25817 26473–26754...... 13 13341...... 29843 93...... 25820 26755–27816...... 14 Administrative Orders: 94...... 25820 27817–28040...... 17 Notices: 95...... 25820 28041–28818...... 18 Notice of May 17, 130...... 25305 28819–29042...... 19 2004 ...... 29041 317...... 28042 29043–29170...... 20 Notice of May 20, 381...... 28042 29171–29410...... 21 2004 ...... 29409 Proposed Rules: 29411–29650...... 24 Presidential 78...... 25338 29651–29844...... 25 Determinations: 317...... 24539 29845–30150...... 26 No. 2004–29 of April 381...... 24539

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10 CFR 25041, 25501, 25503, 25505, 600...... 26768 26042, 27834, 29864 25507, 25511, 25514, 25517, 165 ...... 24513, 24515, 25317, Ch. 1 ...... 29187 807...... 25489 25519, 25521, 25523, 25525, 25319, 26043, 27836, 28825, 2...... 25997 820...... 29786 26052, 26054, 26325, 26326, 28827, 29067, 29069, 29230, 70...... 28043 866...... 26036 26329, 26331, 27865, 27866, 872...... 26302 29232, 29433, 29653, 29656 Proposed Rules: 27868, 28093, 28094, 28860, 1271...... 29786 Proposed Rules: 30...... 28849 28863, 28865, 28867, 29106, Proposed Rules: 110...... 26526 40...... 28849 29108, 29109, 29111, 29477, 50...... 28849 3...... 25527 117 ...... 24548, 27870, 27872 29672, 29910 59...... 29912 165 ...... 24112, 24549, 24552, 60...... 28849 43...... 26054 61...... 28849 101...... 24541 26526, 26531, 26783, 28871, 71 ...... 26056, 26058, 28870 29114, 29246 70...... 28849 121...... 27980 22 CFR 72...... 28849 36 CFR 76...... 28849 15 CFR 121...... 29222 123...... 29222 242...... 28847 12 CFR 736...... 26766 1200...... 26045 744...... 25312 23 CFR Proposed Rules: 208...... 25672 774 ...... 24507, 24508, 25314 229...... 25826, 28819 655...... 25828 7...... 25043 Proposed Rules: 352...... 26490 Proposed Rules: 754...... 25856 37 CFR 614...... 26763, 29852 630...... 26513 615...... 29852 1...... 29865 16 CFR 24 CFR 617...... 26763 3...... 29865 602...... 29061 Proposed Rules: 5...... 29865 620...... 26763 603...... 29061 630...... 26763 81...... 24228 Proposed Rules: 604...... 29061 990...... 24547 1...... 25861 701...... 27827 611...... 29061 703...... 27827 1000...... 25340 709...... 27827 39 CFR 17 CFR 25 CFR 715...... 27827 111...... 25321, 26305 211...... 29064 170...... 28821 723...... 27827 231...... 29064 Proposed Rules: 725...... 27827 501...... 25864 241...... 29064 26 CFR 1805...... 26260 Proposed Rules: 1 ...... 24071, 24078, 25315, 40 CFR Proposed Rules: 15...... 26333 208...... 28851 25489, 26038, 26040, 26304, 9...... 24517 16...... 26333 29066 225...... 28851 17...... 26333 51...... 28830 Proposed Rules: 721...... 29907 18...... 26333 52 ...... 24986, 25835, 25839, 1 ...... 24107, 25534, 25535, 724...... 29907 19...... 26333 26503, 27837, 28061, 29071, 25856, 26782, 29113, 29246, 21...... 26333 29074, 29234, 29253, 29254, 13 CFR 29673 200...... 30142 29255, 29435, 29444, 29446, 121 ...... 25262, 29192, 29411 29449, 29451, 29880, 30006, 210...... 26650 27 CFR 124...... 29192 228...... 26650 30038 9...... 25831 125 ...... 25262, 29192, 29411 229...... 26650 62...... 29658 126...... 29411 63...... 25321 230 ...... 25182, 26650, 30142 29 CFR 134...... 25262, 29192 232...... 26650 82...... 29076 2590...... 30084 Proposed Rules: 239...... 25182, 26650 85...... 26222 121...... 27865 240 ...... 25182, 25778, 26650, Proposed Rules: 86...... 26222 126...... 26511 30142 1926...... 27870 180 ...... 24984, 24992, 26305, 242...... 26650, 30142 4011...... 25797, 28992 26770, 28832, 29454, 29882, 14 CFR 245...... 26650 4022...... 26769 29890, 30042, 30076 23...... 25998 249 ...... 25182, 26650, 30142 4044...... 26769 300...... 26506, 29076 25 ...... 24492, 24936, 26764 275...... 25778 4071...... 25797, 28992 439...... 25324 39 ...... 24063, 24938, 24940, 279...... 25778 716...... 24517 24941, 24944, 24945, 24947, 30 CFR Proposed Rules: 24950, 24952, 24953, 24954, 18 CFR 50...... 26499 51 ...... 25184, 28874, 29118 25479, 25481, 25483, 25485, 381...... 27833 203...... 25499 52 ...... 25051, 25348, 25865, 25488, 26000, 26001, 26003, 206...... 24959, 29432 25866, 25869, 26533, 26786, 26005, 26006, 26008, 26010, 20 CFR 250...... 29433 29119, 29120, 29250, 29480, 26012, 26013, 26015, 26017, 404...... 25949 917...... 26500 29481, 29674, 29913 26018, 26020, 26022, 26024, 408...... 25949 925...... 29864 60...... 25052 26025, 26027, 26299, 26434, Proposed Rules: 62...... 29675 26494, 27829, 27831, 28044, 21 CFR 948...... 26340 63...... 25052 28046, 28051, 29047, 29049, 1 ...... 24070, 28060, 29428 72...... 28874 29054, 29055, 29209, 29210, 73...... 24511 31 CFR 75...... 28874 29212, 29216, 29217, 29218, 110...... 29220 Proposed Rules: 81...... 25869 29651 172...... 24511, 29428 50...... 25341 82...... 26059, 28992 71 ...... 24063, 24064, 24065, 175...... 24511 103...... 28098 96...... 28874 24067, 24068, 25467, 26029, 176...... 24511 180...... 26348 26030, 26031, 26033, 26034, 177...... 24511 32 CFR 191...... 29460 26035, 29058, 29059, 29060, 178...... 24511 199...... 29226 194...... 26351, 29460 29651, 29653 184...... 24511 281...... 25053 95...... 24956 186...... 24511 33 CFR 300...... 29120 97...... 24505, 28058 210...... 29786 62...... 24979 139...... 24069 211...... 29786 66...... 24979 42 CFR Proposed Rules: 335...... 26301 67...... 24979 412...... 25674, 25752 25...... 29910 520...... 24958 72...... 24979 1003...... 28842 39 ...... 24095, 24097, 24099, 522...... 25827 100 ...... 24513, 28823, 29230 Proposed Rules: 24101, 24103, 24105, 25037, 558 ...... 25315, 26498, 28820 117 ...... 24080, 25316, 25317, 403...... 28196

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412...... 28196 64...... 29894 217...... 26507 Proposed Rules: 413...... 28196 69...... 25325 225...... 26508 171...... 25470 418...... 28196 73 ...... 25844, 25845, 25846, 252...... 26508, 26509 172...... 25470 460...... 28196 26312, 29241, 29242 511...... 28063 173...... 25470 480...... 28196 97...... 24996 516...... 28063 175...... 25470 482...... 28196 101...... 25337, 28062 532...... 28063 178...... 25470, 26538 483...... 28196 Proposed Rules: 538...... 28063 571...... 27990 485...... 28196 Ch. 1 ...... 29913 546...... 28063 598...... 27990 489...... 28196 1...... 29676 552...... 28063 2...... 27874 1812...... 26775 44 CFR 50 CFR 15...... 26790 1813...... 26776 65...... 29662 43...... 29676 Proposed Rules: 13...... 24084 206...... 24082 63...... 29676 14...... 29838 17 ...... 24084, 29081, 29101, Proposed Rules: 73 ...... 25873, 25874, 26061, 25...... 28104, 29632 29669 17...... 24114 26353, 27874, 29252, 29253, 31...... 29380 100...... 28847 21...... 24114 29254, 29255, 29917 32...... 29838 223...... 24997 74...... 27874 300...... 24997 46 CFR 52...... 29838 219...... 26533 622...... 24532 48 CFR 310...... 29079 1852...... 29256 648...... 26509 Proposed Rules: Ch. 1 ...... 25280 1853...... 29256 660 ...... 25013, 25026, 28086, 221...... 29481 2...... 25274 1872...... 29256 29464, 29905 5...... 25274 679 ...... 26313, 26320, 29670 47 CFR 6...... 25274 Proposed Rules: 0 ...... 24996, 27843, 29459 13...... 25274 49 CFR 17 ...... 24876, 25055, 27886, 1...... 27843, 29894 14...... 25274 15...... 28066 29121, 29354, 29681 15...... 29459 15...... 25274 192...... 27861, 29903 229...... 26539 25...... 28062, 29894 19...... 25274 232...... 29664 635 ...... 25357, 26540, 28106 54...... 25325 33...... 25274 380...... 28846, 29384 648...... 28875 61...... 25325 36...... 25274 391...... 28846 660...... 29482 63...... 29894 52...... 25274 1520...... 28066 679...... 25056

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REMINDERS 04; published 5-19-04 Bacillus thurigiensis CryIF [FR 04-11350] protein in cotton; The items in this list were COMMENTS DUE NEXT comments due by 6-1-04; editorially compiled as an aid West Coast States and WEEK published 3-31-04 [FR 04- to Federal Register users. Western Pacific 07077] Inclusion or exclusion from fisheries— AGRICULTURE Pacific Coast groundfish; Bacillus thuringiensis this list has no legal DEPARTMENT significance. comments due by 6-1- Cry3Bb1; comments due Agricultural Marketing 04; published 4-29-04 by 6-1-04; published 3-31- Service [FR 04-09649] 04 [FR 04-06930] Fluid milk promotion order; RULES GOING INTO Pacific Coast groundfish; Bacillus thuringiensis VIP3A; regulatory review; comments comments due by 6-1-04; EFFECT MAY 26, 2004 comments due by 6-1- due by 6-1-04; published 3- 04; published 5-5-04 published 3-31-04 [FR 04- 30-04 [FR 04-07003] [FR 04-10206] 06931] ENVIRONMENTAL AGRICULTURE Pacific whiting; comments Flumioxazin; comments due PROTECTION AGENCY DEPARTMENT due by 6-1-04; by 6-1-04; published 3-31- Pesticides; tolerances in food, Forest Service published 4-30-04 [FR 04 [FR 04-07198] animal feeds, and raw Alaska National Interest Lands 04-09844] Rhamnolipid biosurfactant; agricultural commodities: Conservation Act; Title VIII Marine mammals: comments due by 6-1-04; Commercial fishing published 3-31-04 [FR 04- Imidacloprid; published 5-26- implementation (subsistence authorizations— 06933] 04 priority): Federal Subsistence Zero Mortality Rate Goal; Zoxamide; comments due Isoxadifen-ethyl; published Regional Advisory mortality and serious by 6-1-04; published 3-31- 5-26-04 Councils; membership injury threshold level; 04 [FR 04-06932] Ultramarine blue; published qualifications; comments comments due by 6-1- Solid wastes: 5-26-04 due by 6-1-04; published 04; published 4-29-04 State underground storage [FR 04-09753] Toxic substances: 4-15-04 [FR 04-08569] tank program approvals— AGRICULTURE COURT SERVICES AND Missouri; comments due Chemicals of interest to OFFENDER SUPERVISION Occupational Safety and DEPARTMENT by 6-4-04; published 5- Rural Utilities Service AGENCY FOR THE 5-04 [FR 04-10214] Health Administration; in DISTRICT OF COLUMBIA vitro dermal absorption Program regulations: FEDERAL Semi-annual agenda; Open for rate testing requirements; COMMUNICATIONS Seismic safety of federally comments until further published 4-26-04 COMMISSION assisted new building notice; published 12-22-03 INTERIOR DEPARTMENT construction; compliance [FR 03-25121] Common carrier services: requirements; comments Minimum customer account Surface Mining Reclamation ENERGY DEPARTMENT due by 6-1-04; published record exchange and Enforcement Office Federal Energy Regulatory 4-30-04 [FR 04-09611] obligations on all local Commission Permanent program and COMMERCE DEPARTMENT and interexchange abandoned mine land Electric rate and corporate Census Bureau carriers; implementation; reclamation plan regulation filings: comments due by 6-3-04; Special services and studies: submissions: Virginia Electric & Power published 4-19-04 [FR 04- Age Search Program; fee Missouri Co. et al.; Open for 08481] structure; comments due comments until further FEDERAL TRADE Correction; published 5- by 6-1-04; published 4-30- notice; published 10-1-03 COMMISSION 26-04 04 [FR 04-09661] [FR 03-24818] Hart-Scott-Rodino Antitrust TRANSPORTATION COMMERCE DEPARTMENT ENVIRONMENTAL Improvements Act: DEPARTMENT Industry and Security PROTECTION AGENCY Premerger notification; Bureau Air quality implementation Federal Aviation reporting and waiting plans; approval and Administration Export administration period requirements; promulgation; various regulations: comments due by 6-4-04; Airworthiness directives: States: Libya; export and re-export published 4-8-04 [FR 04- Airbus; published 4-21-04 restrictions revision; West Virginia; comments 07537] due by 6-4-04; published BAE Systems (Operations) comments due by 6-1-04; Telemarketing sales rule: Ltd.; published 4-21-04 published 4-29-04 [FR 04- 5-5-04 [FR 04-10095] National Do-Not-Call Bombardier; published 5-11- 09717] Environmental statements; availability, etc.: Registry; user fees; 04 COMMERCE DEPARTMENT comments due by 6-1-04; Coastal nonpoint pollution National Oceanic and published 4-30-04 [FR 04- General Electric Co.; control program— published 5-11-04 Atmospheric Administration 09848] Minnesota and Texas; TRANSPORTATION Fishery conservation and Open for comments HEALTH AND HUMAN DEPARTMENT management: until further notice; SERVICES DEPARTMENT Alaska; fisheries of Food and Drug Research and Special published 10-16-03 [FR Exclusive Economic Administration Programs Administration 03-26087] Zone— Pesticides; tolerances in food, Medical devices: Pipeline safety: Fish meal, fish oil, and animal feeds, and raw Orthopedic devices— Hazardous liquid bone meal; comments agricultural commodities: Hip joint metal/polymer or transportation— due by 6-4-04; 6-Benzyladenine; comments ceramic/polymer published 5-5-04 [FR Gas transmission due by 6-1-04; published semiconstrained 04-10208] pipelines; integrity 4-2-04 [FR 04-07475] resurfacing cemented management in high Northeastern United States Bacillus thurigiensis prosthesis; premarket consequence areas; fisheries— Cry2Ab2; comments due approval requirement correction; published 5- Atlantic bluefish; by 6-1-04; published 3-31- effective date; 26-04 comments due by 6-3- 04 [FR 04-07076] comments due by 6-3-

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04; published 3-5-04 04; published 4-5-04 Airbus; comments due by 6- comments due by 6-1-04; [FR 04-04885] [FR 04-07547] 2-04; published 5-3-04 published 3-31-04 [FR 04- Reports and guidance INTERIOR DEPARTMENT [FR 04-09904] 07245] documents; availability, etc.: National Park Service Bombardier; comments due TRANSPORTATION Evaluating safety of National Park System units in by 6-4-04; published 5-5- DEPARTMENT antimicrobial new animal Alaska; amendments; 04 [FR 04-10253] Research and Special drugs with regard to their comments due by 6-1-04; Empresa Brasileira de Programs Administration microbiological effects on published 4-2-04 [FR 04- Aeronautica S.A. Hazardous materials: bacteria of human health 07131] (EMBRAER); comments Regulatory Flexibility Act concern; Open for LABOR DEPARTMENT due by 6-1-04; published Section 610 and plain comments until further Occupational Safety and 4-29-04 [FR 04-09765] language reviews; notice; published 10-27-03 Health Administration Gulfstream; comments due comments due by 6-1-04; [FR 03-27113] Occupational safety and by 6-2-04; published 5-3- published 3-1-04 [FR 04- HOMELAND SECURITY Health standards: 04 [FR 04-09901] 04401] DEPARTMENT Electrical installation; Gulfstream Aerospace; TREASURY DEPARTMENT Coast Guard comments due by 6-4-04; comments due by 6-1-04; Internal Revenue Service Anchorage regulations: published 4-5-04 [FR 04- published 4-29-04 [FR 04- Income taxes: Maryland; Open for 07033] 09764] Corporate reorganizations; comments until further Pipeline Safety Improvement Lancair Co.; comments due asset and stock transfers; notice; published 1-14-04 Act; discrimination complaint by 6-1-04; published 3-26- transaction requirements; [FR 04-00749] procedures; comments due 04 [FR 04-06498] comments due by 6-1-04; San Francisco Bay, CA; by 6-4-04; published 4-5-04 New Piper Aircraft, Inc.; published 3-2-04 [FR 04- comments due by 6-1-04; [FR 04-07612] comments due by 6-1-04; 04483] published 4-1-04 [FR 04- NATIONAL AERONAUTICS published 3-31-04 [FR 04- Modified accelerated cost 07273] AND SPACE 07128] recovery system property; Drawbridge operations: ADMINISTRATION Sikorsky Aircraft changes in use; depreciation; comments Mississippi; comments due Acquisition regulations: Corporation; comments due by 6-1-04; published by 6-1-04; published 4-1- NASA FAR Supplement due by 6-1-04; published 3-1-04 [FR 04-03993] 04 [FR 04-07272] Subchapter F; reissuance; 3-31-04 [FR 04-06777] TREASURY DEPARTMENT New York; comments due comments due by 6-1-04; Airworthiness standards: by 6-3-04; published 5-4- published 3-31-04 [FR 04- Special conditions— Privacy Act; implementation; 04 [FR 04-10114] 07239] comments due by 6-1-04; Cessna Model 500, 550, published 4-30-04 [FR 04- Ports and waterways safety: NATIONAL ARCHIVES AND and S550 airplanes; RECORDS ADMINISTRATION 09813] Boston Harbor, MA; safety comments due by 6-4- and security zones; Public availability and use: 04; published 5-5-04 comments due by 6-1-04; Records and donated [FR 04-10238] LIST OF PUBLIC LAWS published 3-31-04 [FR 04- historical materials use; Class C airspace; comments 07109] research room due by 6-3-04; published 4- This is a continuing list of procedures; comments Hampton Roads, VA— 19-04 [FR 04-08809] public bills from the current due by 6-1-04; published session of Congress which Security zone; comments Class E airspace; comments 3-31-04 [FR 04-07169] have become Federal laws. It due by 6-3-04; due by 5-31-04; published NUCLEAR REGULATORY may be used in conjunction published 5-4-04 [FR 4-7-04 [FR 04-07879] COMMISSION with ‘‘PLUS’’ (Public Laws 04-10115] Environmental statements; Jet routes; comments due by Update Service) on 202–741– HOUSING AND URBAN availability, etc.: 6-1-04; published 4-15-04 6043. This list is also DEVELOPMENT [FR 04-08506] Fort Wayne State available online at http:// DEPARTMENT Developmental Center; TRANSPORTATION www.archives.gov/ HOME Investment Open for comments until DEPARTMENT federal—register/public—laws/ Partnerships Program: further notice; published National Highway Traffic public—laws.html. American Dream 5-10-04 [FR 04-10516] Safety Administration The text of laws is not Downpayment Initiative; SECURITIES AND Motor vehicle safety published in the Federal comments due by 6-1-04; EXCHANGE COMMISSION standards: Register but may be ordered published 3-30-04 [FR 04- Self-regulatory organizations; Defect and noncompliance— in ‘‘slip law’’ (individual 07122] proposed rule changes; Potential defects; pamphlet) form from the INTERIOR DEPARTMENT amendments; comments due information and Superintendent of Documents, Fish and Wildlife Service by 6-4-04; published 4-5-04 documents reporting; U.S. Government Printing Alaska National Interest Lands [FR 04-07538] comments due by 6-1- Office, Washington, DC 20402 Conservation Act; Title VIII Correction; comments due 04; published 4-16-04 (phone, 202–512–1808). The implementation (subsistence by 6-4-04; published 4-30- [FR 04-08716] text will also be made priority): 04 [FR C4-07538] available on the Internet from Occupant crash protection— GPO Access at http:// Federal Subsistence SMALL BUSINESS Safety equipment removal; www.gpoaccess.gov/plaws/ Regional Advisory ADMINISTRATION exemptions from make index.html. Some laws may Councils; membership Disaster loan areas: inoperative prohibition not yet be available. qualifications; comments Maine; Open for comments for persons with due by 6-1-04; published until further notice; disabilities; comments S. 2315/P.L. 108–228 4-15-04 [FR 04-08569] published 2-17-04 [FR 04- due by 6-4-04; To amend the Endangered and threatened 03374] published 4-20-04 [FR Communications Satellite Act species permit applications: TRANSPORTATION 04-08932] of 1962 to extend the Critical habitat DEPARTMENT National Driver Register deadline for the INTELSAT designations— Federal Aviation Problem Driver Pointer initial public offering. (May 18, Eggert’s sunflower; Administration System; receiving data and 2004; 118 Stat. 644) comments due by 6-4- Airworthiness directives: participation procedures; Last List May 10, 2004

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enacted public laws. To PENS cannot respond to subscribe, go to http:// specific inquiries sent to this Public Laws Electronic listserv.gsa.gov/archives/ address. Notification Service publaws-l.html (PENS) Note: This service is strictly for E-mail notification of new PENS is a free electronic mail laws. The text of laws is not notification service of newly available through this service.

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