15248 Federal Register / Vol. 65, No. 56 / Wednesday, March 22, 2000 / Rules and Regulations

750(4), 340–020–750(4)(b), 340–020– 300965 in the subject line on the first consists of the documents specifically 800(3)-(6), 340–020–890(5), 340–020– page of your response. referenced in this action, and other 900(6)(c), 340–020–910(1)(b), 340–020– FOR FURTHER INFORMATION CONTACT: By information related to this action, 1000(1)(a) and (2), and 340–020– mail: Vera Soltero, Registration Division including any information claimed as 1030(2). (7505C), Office of Pesticide Programs, Confidential Business Information (CBI). (C) EPA approves the changes made to Environmental Protection Agency, Ariel This official record includes the certain sections of the Oregon Rios Bldg., 1200 Pennsylvania Ave., documents that are physically located in Administrative Rules: ‘‘Determining NW., Washington, DC 20460; telephone the docket, as well as the documents Conformity of General Federal Actions number: (703) 308–9359; and e-mail that are referenced in those documents. to State and Federal Implementation address: [email protected]. The public version of the official record Plans’ found in: OAR 340–020–1510, SUPPLEMENTARY INFORMATION: does not include any information 340–020–1520, 340–020–1530, 340– claimed as CBI. The public version of 020–1570, 340–020–1580, and 340–020– I. General Information the official record, which includes 1590, effective September 23, 1998. A. Does This Action Apply to Me? printed, paper versions of any electronic comments submitted during an [FR Doc. 00–6969 Filed 3–21–00; 8:45 am] You may be affected by this action if BILLING CODE 6560±50±P applicable comment period is available you are an agricultural producer, food for inspection in the Public Information manufacturer, or pesticide and Records Integrity Branch (PIRIB), ENVIRONMENTAL PROTECTION manufacturer. Potentially affected Rm. 119, Crystal Mall #2, 1921 Jefferson AGENCY categories and entities may include, but Davis Hwy., Arlington, VA, from 8:30 are not limited to: a.m. to 4 p.m., Monday through Friday, 40 CFR Part 180 excluding legal holidays. The PIRIB telephone number is (703) 305–5805. [OPP±300965; FRL±6485±3] Cat- NAICS Examples of poten- II. Background and Statutory Findings RIN 2070±AB78 egories codes tially affected entities In the Federal Register of September Industry 111 Crop production 1, 1999 (64 FR 47788) (FRL–6098–6), ; Exemption from the EPA issued a notice pursuant to section Requirement of a Tolerance 112 Animal production 311 Food manufacturing 408 of the Federal Food, Drug, and AGENCY: Environmental Protection 32532 Pesticide manufac- Cosmetic Act (FFDCA), 21 U.S.C. 346a, Agency (EPA). turing as amended by the Food Quality Protection Act (FQPA) (Public Law 104– ACTION: Final rule. This listing is not intended to be 170) announcing the filing of a pesticide SUMMARY: This regulation establishes an exhaustive, but rather provides a guide tolerance petition by, Agricultural exemption from the requirement of a for readers regarding entities likely to be Research Services, United States tolerance for residues of cucurbitacins affected by this action. Other types of Department of Agriculture, Agricultural from the powders and juices of the entities not listed in the table could also Research Center, Beltsville, MD 20705. Hawkesbury Citrullus lanatus on be affected. The North American This notice included a summary of the various food commodities when Industrial Classification System petition prepared by the petitioner applied/used as an inert (other) (NAICS) codes have been provided to United States Department of ingredient (gustatory stimulant) in assist you and others in determining Agriculture. There were no comments pesticides applied to growing crops whether or not this action might apply received in response to the notice of only. Agricultural Research Services, to certain entities. If you have questions filing. The petition requested that 40 CFR United States Department of Agriculture regarding the applicability of this action 180.1001(d) be amended by establishing submitted a petition to EPA under the to a particular entity, consult the person an exemption from the requirement of a Federal Food, Drug, and Cosmetic Act, listed under FOR FURTHER INFORMATION tolerance for residues of cucurbitacins as amended by the Food Quality CONTACT. derived from the Hawkesbury melon Protection Act of 1996, requesting an B. How Can I Get Additional Citrullus lanatus. The petitioner noted exemption from the requirement of a Information, Including Copies of This that the Agency had previously tolerance. This regulation eliminates the Document and Other Related established exemptions from the need to establish a maximum Documents? requirement of a tolerance for the use of permissible level for residues of 1. Electronically. You may obtain buffalo gourd and zucchini juice, as cucurbitacins from Hawkesbury melon. electronic copies of this document, and sources of the inert ingredient DATES: This regulation is effective certain other related documents that (57 FR 40128, September 2, March 22, 2000. Objections and requests might be available electronically, from 1992 and 63 FR 43085, August 12, for hearings, identified by docket the EPA Internet Home Page at http:// 1998), and is seeking to add the control number OPP–300965, must be www.epa.gov/. To access this Hawkesbury melon Citrullus lanatus as received by EPA on or before May 22, document, on the Home Page select an additional source of cucurbitacins. 2000. ‘‘Laws and Regulations’’ and then look Section 408(b)(2)(A)(i) of the FFDCA ADDRESSES: Written objections and up the entry for this document under allows EPA to establish an exemption hearing requests may be submitted by the ‘‘Federal Register-Environmental from the requirement for a tolerance (the mail, in person, or by courier. Please Documents.’’ You can also go directly to legal limit for a pesticide chemical follow the detailed instructions for each the Federal Register listings at http:// residue in or on a food) only if EPA method as provided in Unit VIII. of the www.epa.gov/fedrgstr/. determines that the tolerance is ‘‘safe.’’ ‘‘SUPPLEMENTARY INFORMATION.’’ 2. In person. The Agency has Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to To ensure proper receipt by EPA, your established an official record for this mean that ‘‘there is a reasonable objections and hearing requests must action under docket control number certainty that no harm will result from identify docket control number OPP– OPP–300965. The official record aggregate exposure to the pesticide

VerDate 202000 17:06 Mar 21, 2000 Jkt 190000 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM pfrm02 PsN: 22MRR1 Federal Register / Vol. 65, No. 56 / Wednesday, March 22, 2000 / Rules and Regulations 15249 chemical residue, including all effects are expected to occur. Neither contains 0.00139 grams of cucurbitacin. anticipated dietary exposures and all cucurbitacins nor their metabolites are Thus, even under these worst case other exposures for which there is known or expected to have any effect on assumptions, consumption of a pound reliable information.’’ This includes the immune or the endocrine systems. of treated corn would add less exposure through drinking water and in These chemicals are not known to be cucurbitacin to the diet than a gram residential settings, but does not include carcinogenic. serving of squash. At the allowable rate occupational exposure. Section According to information supplied by of application the proposed use of these 408(b)(2)(C) requires EPA to give special USDA, the Hawkesbury watermelon compounds as inert ingredients would consideration to exposure of infants and contains cucurbitacin E-glycoside at result in a negligible increase in children to the pesticide chemical levels in the same order of magnitude exposure to cucurbitacins over those residue in establishing a tolerance and those found in buffalo gourd root levels which would occur naturally as to ‘‘ensure that there is a reasonable powder, 0.76 milligrams (mg) the result of ingestion of various certainty that no harm will result to cucurbitacin E-glycoside/grams (gm) of cucurbit commodities. infants and children from aggregate melon compared to 0.59 mg 2. Drinking water exposure. The exposure to the pesticide chemical cucurbitacin E-glycoside/gm of root Agency review cited in the August 12, residue.* * *’’ powder. The Hawkesbury melon does 1998, Federal Register notice EPA performs a number of analyses to not contain cucurbitacin I. Cucurbitacin established that most cucurbitacins are determine the risks from aggregate I is considered to be more toxic than insoluble in water and transfer of these exposure to pesticide residues. First, cucurbitacin E-glycoside (LD50 of 40 cucurbitacins to ground water is EPA determines the toxicity of milligrams/kilograms (mg/kg) to 5 mg/ unlikely. The more water soluble pesticides. Second, EPA examines kg). Thus, Hawkesbury melon is also glycosylated forms of cucurbitacins are exposure to the pesticide through food, likely to exhibit lower toxicity than less toxic to humans. No uses are drinking water, and through other buffalo gourd root powder, providing an registered for application to bodies of exposures that occur as a result of additional margin of safety. water. pesticide use in residential settings. IV. Aggregate Exposures B. Other Non-Occupational Exposure III. Toxicological Profile In examining aggregate exposure, There are no cucurbitacin-containing Consistent with section 408(b)(2)(D) FFDCA section 408 directs EPA to products with residential uses as all of FFDCA, EPA has reviewed the consider available information uses are for agricultural crop production available scientific data and other concerning exposures from the pesticide only. relevant information in support of this residue in food and all other action and considered its validity, nonoccupational exposures, including V. Cumulative Effects completeness and reliability and the drinking water from ground water or Section 408 (b)(2)(D)(v) of FFDCA relationship of this information to surface water and exposure through requires that, when considering whether human risk. EPA has also considered pesticide use in gardens, lawns, or to establish, modify or revoke a available information concerning the buildings (residential and other indoor tolerance or tolerance exemption, the variability of the sensitivities of major uses). Agency consider ‘‘available identifiable subgroups of consumers, information’’ concerning the cumulative including infants and children. The A. Dietary Exposure effects of a particular chemical’s nature of the toxic effects caused by Species of the family , residues and ‘‘other substances that cucurbitacins are discussed in this unit. such as , and squash, have a common mechanism of toxicity.’’ The Agency in a previous Federal are commonly used as and The Agency has not made any Register notice reviewed mammalian throughout the world, they conclusions as to whether or not toxicity data submitted on zucchini are naturally occurring and widely cucurbitacins share a common juice and buffalo gourd root powder as available. Seeds of several species are mechanism of toxicity with other part of the establishment of an used as sources of flavorings in bakery chemicals. However, the Hawkesbury exemption from the requirement of a goods or for oils and proteins. All of melon juice is expected to be practically tolerance for residues of zucchini juice these species contain some assortment non toxic to mammals. Due to the when used as an alternative source of of naturally occurring cucurbitacins in expected lack of toxicity, a cumulative the inert ingredient gustatory stimulant varying concentrations. risk assessment is not necessary. cucurbitacin (63 FR 43085). A summary 1. Food. In the Federal Register notice of the comparative toxicology data published on August 12, 1998 (63 FR VI. Determination of Safety for U.S. showed a more favorable toxicological 43085), the Agency reviewed available Population, Infants and Children profile for the zucchini juice, as data on the dietary exposure to Cucurbitacins are present in varying compared to the buffalo gourd root cucurbitacins. The use to control corn amounts in many plants regularly powder, as a cucurbit source of rootworm is given as an example. consumed by the general public, such as cucurbitacins. Zucchini juice was Assuming that the maximum permitted squash, gourds and watermelon. shown to be practically non-toxic to level of 3.4 gm/acre/season is applied, Information available to the Agency mammals. The acute oral, acute dermal, with no loss either in the field or during indicates that the maximum projected acute inhalation, primary eye, and skin processing, and that all the material is additional exposure to these compounds irritation were all toxicity category IV. concentrated in the grain, the following is significantly less than that from a No acute systemic toxicity, irritation or exposure would result. The average normal serving of these plants, as dermal sensitization was exhibited in yield of corn in the United States is previously discussed in section the studies performed with the zucchini 120–130 bushels per acre. At 56 pounds IV(A)(1). The residual amount of juice. of corn per bushel, the minimum yield cucurbitacins in a pound of corn, for Due to the low levels of cucurbitacins is 6,720 pounds per acre and the level example, is an order of magnitude less used in the field no acute effects are of cucurbitacin would be 0.000506 than the naturally occurring levels of expected to occur. In addition, due to grams of cucurbitacin per pound of these substances in a single serving of their rapid degradation, no chronic corn. A gram of ‘‘straightneck’’ squash squash. Dietary exposure to

VerDate 202000 17:18 Mar 21, 2000 Jkt 190000 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM pfrm02 PsN: 22MRR1 15250 Federal Register / Vol. 65, No. 56 / Wednesday, March 22, 2000 / Rules and Regulations cucurbitacins through food is not likely enforcement purposes of cucurbitacins A. What Do I Need To Do To File an to significantly increase due to their use from the Hawkesbury melon. Objection or Request a Hearing? as inert ingredients applied to C. Existing Tolerances You must file your objection or agricultural commodities. These request a hearing on this regulation in chemicals are not likely to be found in Prior EPA findings include a temporary exemption for the accordance with the instructions water. In addition, the use sites of the provided in this unit and in 40 CFR part cucurbitacins are all agricultural for the requirements of a tolerance for residues of the buffalo gourd, 178. To ensure proper receipt by EPA, control of Diabriticine beetles (corn you must identify docket control rootworm and beetles). foetidissima, root powder as a source of cucurbitacins in or on the raw number OPP–300965 in the subject line Therefore, non-dietary exposure to on the first page of your submission. All infants and children is not expected. agricultural commodity fields corn for the control of adult corn rootworms (55 requests must be in writing, and must be The Agency had previously mailed or delivered to the Hearing Clerk established in the Federal Register FR 49700, November 30, 1990). In addition, the Agency established a on or before May 22, 2000. notice published on August 12, 1998 (63 1. Filing the request. Your objection permanent exemption from the FR 43085) that cucurbitacins contained must specify the specific provisions in requirement of a tolerance for the in zucchini juice were practically non the regulation that you object to, and the residues of buffalo gourd root powder toxic to mammals. Cucurbitacins in grounds for the objections (40 CFR when used as an inert ingredient Hawkesbury melon are expected to be of 178.25). If a hearing is requested, the (gustatory stimulant) in pesticide similar toxicity. Because of this, the objections must include a statement of formulations applied to growing crops Agency did not use the safety factor the factual issues(s) on which a hearing only (57 FR 40128, September 2, 1992). analysis in evaluating the risk posed by is requested, the requestor’s contentions In 1998, the Agency amended the the compound. This lack of toxicity also on such issues, and a summary of any permanent exemption from the supported not applying an additional evidence relied upon by the objector (40 requirement of a tolerance to add the tenfold safety factor to protect infants CFR 178.27). Information submitted in residues of zucchini juice, Cucurbita and children. In conclusion, the Agency connection with an objection or hearing pepo, to the list of inert ingredients (63 is reasonaly certain that no harm will request may be claimed confidential by FR 43085, August 12, 1998). result to infants and children, or to the marking any part or all of that general population from a minimally D. International Tolerances information as CBI. Information so increased exposure to residues of There are no international tolerances marked will not be disclosed except in cucurbitacins. Based on the information accordance with procedures set forth in in this preamble, EPA concludes that or tolerance exemptions for cucurbitacins. 40 CFR part 2. A copy of the there is a reasonable certainty of no information that does not contain CBI harm from aggregate exposure to E. Conclusion must be submitted for inclusion in the residues. Accordingly, EPA finds that Therefore, based on the information public record. Information not marked exempting cucurbitacin residues from and the data considered, as well as confidential may be disclosed publicly the requirement of a tolerance will be previous tolerance exemptions granted by EPA without prior notice. safe. to cucurbitacins from buffalo gourd root Mail your written request to: Office of VII. Other Considerations powder and zucchini juice, EPA is the Hearing Clerk (1900), Environmental establishing an exemption from the Protection Agency, 401 M St., SW., A. Endocrine Disruptors requirement of a tolerance for residues Washington, DC 20460. You may also FQPA requires EPA to develop a of cucurbitacins from the Hawkesbury deliver your request to the Office of the screening program to determine whether melon. Hearing Clerk in Rm. C400, Waterside certain substances, including pesticides Mall, 401 M St., SW., Washington, DC VIII. Objections and Hearing Requests and inert ingredients, ‘‘may have an 20460. The Office of the Hearing Clerk effect in humans that is similar to an Under section 408(g) of the FFDCA, as is open from 8 a.m. to 4 p.m., Monday effect produced by a naturally occurring amended by the FQPA, any person may through Friday, excluding legal estrogen, or such other endocrine file an objection to any aspect of this holidays. The telephone number for the effect....’’ The Agency has been working regulation and may also request a Office of the Hearing Clerk is (202) 260– with interested stakeholders to develop hearing on those objections. The EPA 4865. a screening and testing program as well procedural regulations which govern the 2. Tolerance fee payment. If you file as a priority setting scheme. As the submission of objections and requests an objection or request a hearing, you Agency proceeds with implementation for hearings appear in 40 CFR part 178. must also pay the fee prescribed by 40 of this program, further testing of Although the procedures in those CFR 180.33(i) or request a waiver of that products containing the inert ingredient regulations require some modification to fee pursuant to 40 CFR 180.33(m). You cucurbitacin for endocrine effects may reflect the amendments made to the must mail the fee to: EPA Headquarters be required. At this moment, there is no FFDCA by the FQPA of 1996, EPA will Accounting Operations Branch, Office evidence that cucurbitacins are continue to use those procedures, with of Pesticide Programs, P.O. Box endocrine disruptors. appropriate adjustments, until the 360277M, Pittsburgh, PA 15251. Please necessary modifications can be made. identify the fee submission by labeling B. Analytical Method(s) The new section 408(g) provides it ‘‘Tolerance Petition Fees.’’ The Agency is establishing an essentially the same process for persons EPA is authorized to waive any fee exemption from the requirement of a to ‘‘object’’ to a regulation for an requirement ‘‘when in the judgement of tolerance without any change in the exemption from the requirement of a the Administrator such a waiver or previously established limits of no more tolerance issued by EPA under new refund is equitable and not contrary to than 2.5 pounds/acre/season (3.4 grams section 408(d), as was provided in the the purpose of this subsection.’’ For cucurbitacin/acre/season). Therefore, old FFDCA sections 408 and 409. additional information regarding the the Agency has concluded that an However, the period for filing objections waiver of these fees, you may contact analytical method is not required for is now 60 days, rather than 30 days. James Tompkins by phone at (703) 305–

VerDate 202000 17:06 Mar 21, 2000 Jkt 190000 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM pfrm02 PsN: 22MRR1 Federal Register / Vol. 65, No. 56 / Wednesday, March 22, 2000 / Rules and Regulations 15251

5697, by e-mail at IX. Regulatory Assessment that have federalism implications’’ is [email protected], or by mailing a Requirements defined in the Executive Order to request for information to Mr. Tompkins This final rule establishes an include regulations that have at Registration Division (7505C), Office exemption from the tolerance ‘‘substantial direct effects on the States, of Pesticide Programs, Environmental requirement under FFDCA section on the relationship between the national Protection Agency, 401 M St., SW., 408(d) in response to a petition government and the States, or on the Washington, DC 20460. submitted to the Agency. The Office of distribution of power and Management and Budget (OMB) has responsibilities among the various If you would like to request a waiver levels of government.’’ This final rule of the tolerance objection fees, you must exempted these types of actions from review under Executive Order 12866, directly regulates growers, food mail your request for such a waiver to: processors, food handlers and food James Hollins, Information Resources entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). retailers, not States. This action does not and Services Division (7502C), Office of This final rule does not contain any alter the relationships or distribution of Pesticide Programs, Environmental information collections subject to OMB power and responsibilities established Protection Agency, 401 M St., SW., approval under the Paperwork by Congress in the preemption Washington, DC 20460. Reduction Act (PRA), 44 U.S.C. 3501 et provisions of FFDCA section 408(n)(4). 3. Copies for the Docket. In addition seq., or impose any enforceable duty or X. Submission to Congress and the to filing an objection or hearing request contain any unfunded mandate as Comptroller General with the Hearing Clerk as described in described under Title II of the Unfunded The Congressional Review Act, 5 Unit VIII.A., you should also send a Mandates Reform Act of 1995 (UMRA) U.S.C. 801 et seq., as added by the Small copy of your request to the PIRIB for its (Public Law 104–4). Nor does it require any prior consultation as specified by Business Regulatory Enforcement inclusion in the official record that is Fairness Act of 1996, generally provides described in Unit I.B.2. Mail your Executive Order 13084, entitled Consultation and Coordination with that before a rule may take effect, the copies, identified by docket control agency promulgating the rule must number OPP–300965, to: Public Indian Tribal Governments (63 FR 27655, May 19,1998); special submit a rule report, which includes a Information and Records Integrity considerations as required by Executive copy of the rule, to each House of the Branch, Information Resources and Order 12898, entitled Federal Actions to Congress and to the Comptroller General Services Division (7502C), Office of Address Environmental Justice in of the United States. EPA will submit a Pesticide Programs, Environmental Minority Populations and Low Income report containing this rule and other Protection Agency, Ariel Rios Bldg., Populations (59 FR 7629, February 16, required information to the U.S. Senate, 1200 Pennsylvania Ave., NW., 1994); or require OMB review or any the U.S. House of Representatives, and Washington, DC 20460. In person or by Agency action under Executive Order the Comptroller General of the United courier, bring a copy to the location of 13045, entitled Protection of Children States prior to publication of this final the PIRIB described in Unit I.B.2. You from Environmental Health Risks and rule in the Federal Register. This final may also send an electronic copy of Safety Risks (62 FR 19885, April 23, rule is not a ‘‘major rule’’ as defined by your request via e-mail to: opp- 1997). This action does not involve any 5 U.S.C. 804(2). [email protected]. Please use an ASCII technical standards that would require List of Subjects in 40 CFR Part 180 file format and avoid the use of special Agency consideration of voluntary characters and any form of encryption. consensus standards pursuant to section Environmental protection, Copies of electronic objections and 12(d) of the National Technology Administrative practice and procedure, Agricultural commodities, Pesticides hearing requests will also be accepted Transfer and Advancement Act of 1995 and pests, Reporting and recordkeeping on disks in WordPerfect 6.1/8.0 file (NTTAA), Public Law 104–113, section requirements. format or ASCII file format. Do not 12(d) (15 U.S.C. 272 note). Since include any CBI in your electronic copy. tolerances and exemptions that are Dated: March 7, 2000. You may also submit an electronic copy established on the basis of a petition James Jones, under FFDCA section 408(d), such as of your request at many Federal Director, Registration Division, Office of the exemption in this final rule, do not Depository Libraries. Pesticide Programs. require the issuance of a proposed rule, Therefore, 40 CFR chapter I is the requirements of the Regulatory B. When Will the Agency Grant a amended as follows: Request for a Hearing? Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the PART 180Ð[AMENDED] A request for a hearing will be granted Agency has determined that this action if the Administrator determines that the will not have a substantial direct effect 1. The authority citation for part 180 material submitted shows the following: on States, on the relationship between continues to read as follows: There is a genuine and substantial issue the national government and the States, Authority: 21 U.S.C. 321(q), 346(a) and of fact; there is a reasonable possibility or on the distribution of power and 371. that available evidence identified by the responsibilities among the various 2. In § 180.1001, the table in requestor would, if established resolve levels of government, as specified in paragraph (d), is amended by adding ‘‘or one or more of such issues in favor of Executive Order 13132, entitled Hawkesbury melon Citrullus lanatus’’ to the requestor, taking into account Federalism (64 FR 43255, August 10, the end of the entry for ‘‘Buffalo gourd uncontested claims or facts to the 1999). Executive Order 13132 requires root powder’’ to read as follows: contrary; and resolution of the factual EPA to develop an accountable process to ensure ‘‘meaningful and timely input § 180.1001 Exemptions from the issues(s) in the manner sought by the requirement of a tolerance requestor would be adequate to justify by State and local officials in the development of regulatory policies that the action requested (40 CFR 178.32). * * * * * have federalism implications.’’ ‘‘Policies (d)* * *

VerDate 202000 17:06 Mar 21, 2000 Jkt 190000 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM pfrm02 PsN: 22MRR1 15252 Federal Register / Vol. 65, No. 56 / Wednesday, March 22, 2000 / Rules and Regulations

Inert Ingredients Limits Uses

*******

Buffalo gourd root powder (Cucurbita foetidissima root powder), Zucchini juice *** *** (Cucur bita pepo juice) or Hawkesbury melon Citrullus lanatus.

*******

* * * * * opposed some provisions of the Final Licensing, Federal Maritime [FR Doc. 00–6863 Filed 3–21–00; 8:45 am] Rule. However, after reviewing these Commission, 800 North Capitol BILLING CODE 6560±50±F comments, the Department has Street, NW, Washington, DC 20573– concluded that the comments raised no 0001; (202) 523–5788 significant issues not addressed Thomas Panebianco, General Counsel, DEPARTMENT OF HEALTH AND previously in the history of this Federal Maritime Commission, 800 HUMAN SERVICES rulemaking. Indeed, the comments North Capitol St., NW, Washington, raised issues which were addressed in DC 20573–0001; (202) 523–5740 42 CFR Part 121 the amendments published on October SUPPLEMENTARY INFORMATION: On 20, 1999 (64 FR 56650), and in February 14, 2000, the Federal Maritime Organ Procurement and explanatory language in the preamble to Commission (‘‘FMC’’ or ‘‘Commission’’) Transplantation Network; Response to those amendments. Comment Period For these reasons, the Department has published a proposed rule to amend 46 determined that no further amendments CFR 515.11(c) to allow affiliated AGENCY: Health Resources and Services companies to have the same qualifying Administration, HHS. to the Final Rule are warranted by the most recent public comments at this individual to obtain a license under this ACTION: Final rule; response to time. part. 65 FR 7335. The proceeding was comments. initiated in response to a petition filed Dated: March 17, 2000. with the Commission by the National SUMMARY: Section 413 of the Ticket to Claude Earl Fox, Customs Brokers & Forwarders Work and Work Incentives Administrator, Health Resources and Services Association of America (‘‘NCBFAA’’) Improvement Act of 1999, signed into Administration. which sought the issuance of a law by the President on December 17, declaratory order confirming, pursuant 1999, provided that the Organ Approved: March 17, 2000. to 46 CFR 515.11(c) (1999), that a single Procurement and Transplantation Donna E. Shalala, individual can act contemporaneously Network (OPTN) Final Rule published Secretary. on April 2, 1998, together with the as the qualifying individual for both an [FR Doc. 00–7177 Filed 3–20–00; 12:19 pm] ocean freight forwarder and a non- amendments published on October 20, BILLING CODE 4160±15±P 1999, was not to become effective before vessel-operating common carrier March 16, 2000. The Department (‘‘NVOCC’’), as long as they are affiliated entities. In the alternative, published a notice in the Federal FEDERAL MARITIME COMMISSION Register on December 21, 1999, NCBFAA sought a rulemaking to amend § 515.11(c) to achieve the same result. announcing the stay of the Final Rule 46 CFR Part 515 and informing the public of the As discussed in the notice of proposed opportunity to submit comments on the [Docket No. 99±23] rulemaking, the Commission denied NCBFAA’s petition for a declaratory Final Rule, as amended, for a 60-day In the Matter of a Single Individual period. After considering the comments order, and opted to address its concerns Contemporaneously Acting as the through a rulemaking. submitted, the Department has Qualifying Individual for Both an determined that no further amendments Although not addressed in NCBFAA’s Ocean Freight Forwarder and a Non- petition, the Commission also proposed to the Final Rule are warranted at this Vessel-Operating Common Carrier time. to amend the definition of ‘‘branch office’’ at 46 CFR 515.2(c), by removing DATES: The Final Rule published on AGENCY: Federal Maritime Commission. the last sentence of the definition, April 2, 1998 (63 FR 16296) and ACTION: Final rule. which states that the term does not amended on October 20, 1999 (64 FR include a separately incorporated 56650) became effective on March 16, SUMMARY: The Federal Maritime branch office. We explained that the 2000. Commission amends its regulations pertaining to the licensing requirements Commission has recognized separately FOR FURTHER INFORMATION CONTACT: of ocean transportation intermediaries incorporated branch offices elsewhere Lynn Rothberg Wegman, Director, in accordance with the Shipping Act of in part 515, particularly with respect to Division of Transplantation, Office of 1984, as amended by The Ocean the licensing and financial Special Programs, HRSA, 5600 Fishers Shipping Reform Act of 1998. We are responsibility requirements, and that Lane, Room 7C–22, Rockville, Maryland also republishing a certification process the proposed modification should 20857. Telephone: 301–443–7577. pertaining to drug convictions that was remove any potential confusion. SUPPLEMENTARY INFORMATION: In previously omitted. Finally, we noted that in response to the Federal Register notice promulgating the rules to implement the of December 21, 1999 (64 FR 71626), the DATES: This rule becomes effective Ocean Shipping Reform Act of 1998, Department received 2,561 public March 22, 2000. Pub. L. 105–258, 112 Stat. 1902, in comments. Of these, 2,205 were form FOR FURTHER INFORMATION CONTACT: Docket No. 98–28, Licensing, Financial letters. All of the form letters and a Sandra L. Kusumoto, Director, Bureau of Responsibility Requirements and majority of the individual comments Consumer Complaints and General Duties for Ocean

VerDate 202000 17:06 Mar 21, 2000 Jkt 190000 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM pfrm02 PsN: 22MRR1