The Oriental fruit fly, Bactrocera dorsalis (Hendel), is a destructive pest of citrus and other types of fruit, nuts, vegetables, and berries. The short life cycle of the Oriental fruit fly allows rapid development of serious outbreaks, which can cause severe economic losses. Heavy infestations can cause complete loss of crops.

The Oriental fruit fly regulations, contained in 7 CFR 301.93 through 301.93-10 (referred to below as the regulations), were established to prevent the spread of the Oriental fruit fly to noninfested areas of the United States. Section 301.93-3(a) provides that the Administrator will list as a quarantined area each State, or each portion of a State, in which the Oriental fruit fly has been found by an inspector, in which the Administrator has reason to believe the Oriental fruit fly is present, or that the Administrator considers necessary to regulate because of its proximity to the Oriental fruit fly or its inseparability for quarantine enforcement purposes from localities in which the Oriental fruit fly has been found. The regulations impose restrictions on the interstate movement of regulated articles from the quarantined areas. Quarantined areas are listed in § 301.93-3(c).

Less than an entire State will be designated as a quarantined area only if the Administrator determines that: (1) The State has adopted and is enforcing restrictions on the intrastate movement of regulated articles that are substantially the same as those imposed on the interstate movement of regulated articles; and (2) The designation of less than the entire State as a quarantined area will prevent the interstate spread of the Oriental fruit fly.

Recent trapping surveys by inspectors of California State and county agencies and by inspectors of the Animal and Plant Health Inspection Service (APHIS) reveal that a portion of San Bernardino County, CA, is infested with the Oriental fruit fly. The Oriental fruit fly is not known to exist anywhere else in the continental United States.

State agencies in California have begun an intensive Oriental fruit fly eradication program in the quarantined area in San Bernardino County. Also, California has taken action to restrict the intrastate movement of regulated articles from the quarantined area.

Accordingly, to prevent the spread of the Oriental fruit fly to other States, we are amending the regulations in § 301.93-3 by designating a portion of San Bernardino County, CA, as a quarantined area for the Oriental fruit fly. The quarantined area is described in the rule portion of this document.

This rulemaking is necessary on an emergency basis to prevent the Oriental fruit fly from spreading to noninfested areas of the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register.

We will consider comments that are received within 60 days of publication of this rule in the Federal Register. After the comment period closes, we will publish another document in the Federal Register. The document will include a discussion of any comments we receive and any amendments we are making to the rule as a result of the comments.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review process required by Executive Order 12866.

This action amends the Oriental fruit fly regulations by adding a portion of San Bernardino County, CA, to the list of quarantined areas. The regulations restrict the interstate movement of regulated articles from the quarantined area. County records indicate there are 10 to 15 small growers within the quarantined area who will be affected by this rule. There is no commercial agricultural acreage nor any flea markets or certified farmers markets within the quarantined area. The number of nurseries and fruit and produce dealers located within the quarantined area is presently unknown.

We expect that any small entities located within the quarantined area that sell regulated articles do so primarily for local intrastate, not interstate, movement, so the effect, if any, of this rule on these entities appears to be minimal. The effect on any small entities that may move regulated articles intrastate will be minimized by the availability of various treatments that, in most cases, will allow these small entities to move regulated articles interstate with very little additional cost.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This interim rule has been reviewed under Executive Order 12988, Civil Justice Reform. The rule: (1) Preempts all State or local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties who may file suit in court challenging this rule.

An environmental assessment and finding of no significant impact have been prepared for this interim rule. The site-specific environmental assessment provides a basis for the conclusion that the implementation of integrated pest management to eradicate the Oriental fruit fly will not have a significant impact on human health and the natural environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

Copies of the environmental assessment and finding of no significant impact are available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 am. and 4:30 p.m. Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 690-2817 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

This interim rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Pamlico NDB was decommissioned on October 12, 1999, canceling the SIAP to the Ocracoke Island Airport served by this NAVAID. The extension to the Class E airspace, to accommodate the SIAP, is no longer required. As a result, the airspace legal description must be amended. This rule will become effective on the date specified in the EFFECTIVE DATE section. Since this action eliminates the impact of controlled airspace on the users of the airspace in the vicinity of the Ocracoke Island Airport, Ocracoke, NC, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Class E airspace designations for airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR part 71) amends Class E5 airspace at Ocracoke, NC.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Baxter Pharmaceutical Products, Inc., 110 Allen Rd., Liberty Corner, NJ 07938, has informed FDA of a change of name and address to Baxter Healthcare Corp., 95 Spring St., New Providence, NJ 07974. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the changes.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.

Dow B. Hickam, Inc., Pharmaceuticals, P.O. Box 35413, Houston, TX 77035, has informed FDA that it has transferred to Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478, ownership of, and all rights and interests in NADA 39-583. Accordingly, the agency is amending the regulations in 21 CFR 524.2620 to reflect the transfer of ownership.

In addition, Bertek Pharmaceuticals, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c)(1) and (c)(2) is being amended to add entries for the firm.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, is the sponsor of NADA 141-151 that provides for use of ZeniquinTM (marbofloxacin) Tablets for the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin. Pfizer, Inc., filed a supplemental NADA which provides for the addition of cats to product indications. The supplemental NADA is approved as of August 1, 2001, and the regulations in 21 CFR 520.1310 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for non-food-producing animals qualifies for 3 years of marketing exclusivity beginning August 1, 2001, because the application contains substantial evidence of effectiveness of the drug involved or any studies of animal safety required for approval of the application and conducted or sponsored by the applicant.

The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Animal drugs.

1. The authority citation for 21 CFR part 520 continues to read as follows:

(a) Specifications. Each tablet contains 25, 50, 100, or 200 milligrams (mg) marbofloxacin.

Fort Dodge Animal Health, Div. of American Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501, filed supplemental NADA 141-099 that provides for use of Cydectin® (moxidectin) 0.5% Pour-On for Beef and Dairy Cattle at 500 micrograms moxidectin per kilogram of body weight for treatment and control of infections of additional life stages and species of gastrointestinal roundworms. The supplemental NADA is approved as of June 18, 2001, and the regulations are amended in 21 CFR 524.1451 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

FDA is amending the animal drug regulations in § 556.500 (21 CFR 556.500) to reflect the tolerance for the sum of residues of the tetracyclines in milk, which had been established in a final rule published in the Federal Register of September 30, 1998 (63 FR 52157 at 52158), but removed in a subsequent amendment to § 556.500 in a final rule published in the Federal Register of October 27, 1998 (63 FR 57245 at 57246). At this time, § 556.500 is being amended to reflect the correct tolerance of 0.3 part per million for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline in milk.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Publication of this document constitutes final action on this changes under the Administrative Procedure Act (5 U.S.C. 553).

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 556 is amended as follows:

1. The authority citation for 21 CFR part 556 continues to read as follows:

2. Section 556.500 is amended by revising paragraph (b) to read as follows:

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-179 that provides for use of AVATEC® (90.7 grams per pound (g/lb) of lasalocid sodium) and BMD® (50 g/lb of bacitracin methylene disalicylate) Type A medicated articles to make combination drug Type C medicated turkey feeds. The combination Type C medicated feeds are used for prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, E. adenoeides, and for increased rate of weight gain and improved feed efficiency in growing turkeys. The NADA is approved as of July 11, 2001, and the regulations are amended in 21 CFR 558.311 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(2) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

1. The authority citation for 21 CFR part 558 continues to read as follows:

2. Section 558.311 is amended in the table in paragraph (e)(1) by alphabetically adding an item under entry (xv) following “Bacitracin 4 to 50” to read as follows:

Stateside military banking began in 1941 when the Department realized that financial services were urgently needed by military and civilian personnel on domestic installations. To address this need, the Department permitted installation commanders to negotiate with nearby local banks to establish branches on their installation. Today, there are over 230 domestic installations that have either a bank or credit union or both. To ensure consistency between installations in the level, cost and types of financial services offered, the Department established regulations in parts 230 and 231 to govern the operation and oversight of these institutions. These regulations limit the number of financial institutions that may operate on an installation to one bank and one credit union (with a grandfather provision). The regulations require full and open competition for a full spectrum of banking services (to include electronic banking services). Policy guidance relating to the military banking program, by regulation, is the responsibility of the Under Secretary of Defense (Comptroller) while operational guidance rests with the Defense Finance and Accounting Service (DFAS). To ensure financial services are available on our overseas installations, the Department operates the overseas military banking program. The DFAS has been assigned the program office responsibilities for this effort, which is provided under contract by a domestic financial institution. In FY 2000, the overseas military banking program contractor operated 110 banking offices and over 250 automated teller machines in 10 foreign countries. Overseas military banks support DoD personnel and their families, disbursing officers, appropriated fund activities (such as the Defense Commissary Agency) and nonappropriated fund activities (such as the Army and Air Force Exchange Service).

The Department of Defense published the proposed rule on August 11, 1999 (64 FR 43856). Over 240 comments from 55 entities were received in response to the publication of the previously published proposed rule. The majority of the comments on Part 230 of the proposed rule focused on two areas: (1) Prohibiting the assessment of automated teller machine (ATM) surcharging and (2) the establishment of a ceiling for other fees and charges. These comments and their disposition are specifically addressed below. The remainder of the comments were either administrative in nature or suggested that additional clarification was needed in certain areas. None of these resulted in any significant changes to the proposed rule.

This section of the previously published proposed rule would have required that on-base ATM service offered by financial institutions operating on domestic installations and domestic credit unions operating on DoD installations overseas be provided without surcharge. Forty-nine of the fifty-five entities providing comments objected to this limitation. While being sympathetic to the Department's interest in shielding lower income military members and civilian employees from ATM fees, the comments essentially reflected the belief that the freedom from any regulatory constraints relating to a surcharge fee structure should be permitted to create an environment by which the “economics of the marketplace” determine the level of any surcharges that an institution might consider levying. In this regard, such factors as operational expense structures, ATM usage factors and the convenience factor should be the litmus test of the extent to which surcharges, if any, should be imposed by the financial institution installing the ATM. It was also noted that ATM surcharges typically are incurred by noncustomers, i.e., by persons who have chosen to use a particular financial institution's ATM, but have chosen not to establish an account relationship with that institution. Thus, the incurring of ATM surcharges is voluntary and an individual can readily avoid surcharges by either establishing a deposit account with that institution or by only using the ATMs of the individual's existing depositary institution. Those entities providing comments on this section made a number of compelling arguments to retain the existing requirement that requires the banking liaison officer (BLO) and credit union liaison officer (CULO) annually review service charges and fees (to include surcharges on ATM transactions). As a result, this section has been deleted in its entirety.

This section of the previously published proposed rule would have required that retail fees and services for products (to include related minimum balance requirements for noninterest checking, Negotiable Order of Withdrawal (NOW) and savings accounts) offered by financial institutions operating on DoD installations shall not exceed 110 percent of the industry-wide averages for banks in the “Annual Report to Congress on Retail Fees and Services of Depository Institutions,” published by the Board of Governors of the Federal Reserve System. In its comments, the National Association of Federal Credit Unions (NAFCU) took exception to the 110 percent limitation citing that a credit union's fee structure is designed to allow credit unions to provide members with convenient and efficient services, as well as, a good return on their ownership interest. The Department has reviewed the concerns expressed and, based on its review, has removed the 110 percent ceiling requirement.

It has been determined that 32 CFR part 230 is not a significant regulatory action. The rule does not:

(1) Have an annual effect to the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.

It has been certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule is being promulgated to provide administrative guidelines for the operation of banks and credit unions on domestic and overseas installations of the Department of Defense and address areas such as the solicitation for such services, the types of services and the logistics support provided.

It has been certified that this part does not impose any reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

It has been certified that the rule does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

It has been certified that the rule does not have federalism implications. The rules do not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

Hampton Bay Days, Inc. will sponsor the Hampton Bay Days Festival on September 7-9, 2001 on the Hampton River, Hampton, Virginia. The festival will include water ski demonstrations, personal watercraft and wake board competitions, paddle boat races, classic boat displays, fireworks displays and a helicopter rescue demonstration. A fleet of spectator vessels is expected to gather nearby to view the festival events. In order to ensure the safety of participants, spectators and transiting vessels, 33 CFR 100.508 will be in effect for the duration of the festival activities. Under provisions of 33 CFR 100.508, vessels may not enter the regulated area without permission from the Coast Guard Patrol Commander, except that vessels may enter and anchor in the special spectator anchorage areas if they proceed at slow, no wake speed. The Coast Guard Patrol Commander will allow vessels to transit the regulated area between festival events. Because these restrictions will be in effect for a limited period, they should not result in a significant disruption of maritime traffic.

In addition to this notice, the maritime community will be provided extensive advance notification via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. In keeping with 5 U.S.C. 553(b)(B) and 553(d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this rule effective less than 30 days after publication in the Federal Register. The high-speed boat races will take place on September 22 and 23, 2001. The special local regulations are necessary to provide for the safety of event participants, support vessels, spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event. In addition, advance notifications will be made via the Local Notice to Mariners, marine information broadcasts, and area newspapers.

The North-South Racing Association will sponsor the Sharptown Outboard Regatta on September 22 and 23, 2001. The event will consist of 50 hydroplanes and runabouts conducting a high-speed competitive race on the waters of the Nanticoke River between the Maryland S.R. 313 bridge at Sharptown, Maryland and Nanticoke River Light 43 (LLN-24175). A fleet of spectator vessels is anticipated for the event. Due to the need for vessel control during the races, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels.

The Coast Guard is establishing temporary special local regulations on specified waters of the Nanticoke River. The regulated area will include waters of the Nanticoke River between Maryland S.R. 313 bridge at Sharptown, Maryland and Nanticoke River Light 43 (LLN-24175). The temporary special local regulations will be enforced from 11 a.m. to 6 p.m. eastern time on September 22 and 23, 2001, and will restrict general navigation in the regulated area during the event. Except for participants in the Sharptown Outboard Regatta and persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979).

Although this regulation prevents traffic from transiting a portion of the Nanticoke River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers so mariners can adjust their plans accordingly.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in the effected portions of the Nanticoke River during the event.

Although this regulation prevents traffic from transiting a portion of the Nanticoke River during the event, the effect of this regulation will not be significant because of the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers so mariners can adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pubic Law 104-121), we want to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State law or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial and direct effect on one or more Indian tribes, on the relationship between the Federal Governments and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We prepared an “Environmental Assessment” in accordance with Commandant Instruction M16475.1C, and determined that this rule will not significantly affect the quality of the human environment. The “Environmental Assessment” and “Finding of No Significant Impact” is available in the docket where indicated under ADDRESSES.

The Wilmington YMCA will sponsor the Wilmington YMCA Triathlon on September 16, 2001 on the waters of Wrightsville Channel, Wrightsville Beach, North Carolina. The event will involve 500 swimmers racing along a course within the regulated area. In order to ensure the safety of the swimmers and transiting vessels, 33 CFR 100.513 will be in effect for the duration of the event. Under provisions of 33 CFR 100.513, a vessel may not enter the regulated area unless it receives permission from the Coast Guard Patrol Commander.

In addition to this notice, the maritime community will be provided extensive advance notification via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. In keeping with 5 U.S.C. 553(b)(B) and 553(d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this rule effective less than 30 days after publication in the Federal Register. The swimming event will take place on September 15, 2001. The special local regulations are necessary to provide for the safety of event participants, support vessels, spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event. In addition, advance notifications will be made via the Local Notice to Mariners, marine information broadcasts, and area newspapers.

On September 15, 2001, Diamond State Games 2001 will sponsor the Escape from Fort Delaware Triathlon. The swimming segment of the triathlon will be conducted on a portion of the Delaware River between Pea Patch Island and Delaware City, Delaware. A fleet of spectator vessels is expected to gather near the event site to view the triathlon. To provide for the safety of participants, spectators and other transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the event.

The Coast Guard is establishing temporary special local regulations on specified waters of the Delaware River between Pea Patch Island and Delaware City, Delaware. The temporary special local regulations will be in effect from 7:45 a.m. to 10:15 a.m. eastern time on September 15, 2001. The effect will be to restrict general navigation in the regulated area during the event. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979).

Although this regulation prevents traffic from transiting a portion of the Delaware River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers so mariners can adjust their plans accordingly.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in the effected portions of the Delaware River during the event.

Although this regulation prevents traffic from transiting a portion of the Delaware River during the event, the effect of this regulation will not be significant because of the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers so mariners can adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State law or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial and direct effect on one or more Indian tribes, on the relationship between the Federal Governments and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(h), of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade are specifically excluded from further analysis and documentation under that section. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.

On August 20, 2001, the State of Maryland submitted a formal revision to its State Implementation Plan (SIP). This SIP revision, submitted by the Maryland Department of the Environment (MDE), consists of the Code of Maryland Regulations (COMAR) 26.11.19.27, Control of Volatile Organic Compound (VOC) Emissions From Marine Vessel Coating Operations.

A. Applicability—COMAR 26.11.19.27 applies to sources, where marine vessel coating operations are performed, with facility-wide potential VOC emissions of 25 tons per year or more or actual emissions of 20 pounds per day.

B. Definitions—COMAR 26.11.19.27 defines the following terms: Air flask coating, Antenna coating, Antifoulant coating, Chemical agent resistant coating, Heat resistant coating, High gloss coating, High-temperature coating, Inorganic zinc (high build) coating, Marine vessel coating operation, Mist/tack coating, Navigational aids coating, Nonskid coating, Nuclear coating, Organic zinc coating, Pretreatment wash primer coating, Rubber camouflage coating, Sealant coating, Ship, Special marking coating, Speciality interior coating, Thermoplastic coating, Undersea weapons systems coating, Weld-through (shop) preconstruction primer.

C. Coating Requirements—COMAR 26.11.19.27 establishes limits for the following marine vessel coatings:

In addition to the limit on the VOC content of the coatings listed above, the following requirements apply:

(1) A coating which satisfies the definition of more than one category of coating is subject to the maximum VOC content which applies to the applicable coating category,

(2) Any other coatings not specifically listed in the regulation may not exceed a VOC content of 2.83 pounds per gallon (340 grams per liter), as applied, and

(3) The limits established by the new regulation may be exceeded by 20 percent, but only during the time period between November 1 of a given year through March 31 of the following year.

D. Clean-Up Requirements—This regulation also requires reasonable precautions to minimize the release of VOCs into the atmosphere. These work-practice requirements include:

(1) Storing all waste materials containing VOC, including cloth and paper, in closed containers, (2) Maintaining lids on any VOC-bearing materials when not in use, and

(3) Using enclosed containers or VOC recycling equipment to clean spray gun equipment.

E. Compliance—Compliance must be demonstrated in accordance with COMAR 26.11.19.02.

F. Record keeping—Records of total volume and VOC content of each coating, coating solvent, and cleanup solvent used that contains VOCs must be maintained on a monthly basis and retained for at least three years.

This SIP revision imposing RACT to control VOC emissions from marine vessel coating operations is consistent with federal guidelines and will result in significant VOC emission reductions. EPA has determined that COMAR 26.11.19.27 is approvable as a SIP revision.

Final Action: EPA is approving the addition of COMAR 26.11.19.27, Control of Volatile Organic Compound (VOC) Emissions from Marine Vessel Coating Operations as a revision to the Maryland SIP as submitted by MDE on August 20, 2001. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipate no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on October 22, 2001 without further notice unless EPA receives adverse comment by October 5, 2001. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.” See 66 FR 28355, May 22, 2001. This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law.

Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 5, 2001. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action, approving Maryland's regulation imposing RACT to control VOC emissions from marine vessel coating operations, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to theFederal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.hhtml, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301159. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of June 21, 2000 (65 FR 38543) (FRL-6557-3), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by AgrEvo USA Company, Little Falls Centre One, 2711 Centerville Road, Wilmington, DE 19808. This notice included a summary of the petition prepared by Aventis (formerly AgrEvo), the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.511 be amended by establishing a tolerance for residues of the insecticide buprofezin in or on almonds, nutmeats at 0.05 part per million (ppm); almonds, hulls, at 0.7 ppm; bananas at 0.1 ppm, the citrus crop group, fruit, at 0.7 ppm, cotton seed at 1.0 ppm, grapes at 0.4 ppm, and tomatoes, fruit at 0.8 ppm; in or on the following processed commodities: citrus oil at 26 ppm; citrus pulp, dried, at 2.5 ppm; cotton gin by-products at 23 ppm; and raisins at 1.0 ppm; and in or on the following meat and milk commodities: the fat, meat and meat byproducts of cattle, goats, hogs, horses, and sheep at 0.05 ppm; and milk at 0.01 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that“ there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of buprofezin, on almond; banana; citrus; citrus, oil; citrus, dried pulp; grape; grape, raisin; milk; fat (cattle, goats, hogs, horses, sheep); meat byproducts (cattle, goats, hogs, horses, sheep); liver (cattle, goats, hogs, horses, sheep); almond, hulls; cotton, undelinted seed; cotton, gin byproducts and tomato at 0.05, 0.20, 2.0, 60, 6.0, 0.40, 0.60, 0.01, 0.05, 0.05, 0.05, 0.70, 0.40, 15, 0.40 ppm, respectively. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by buprofezin are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to theFederal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301165. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for combined residues of the insect growth regulator pyriproxyfen, [2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or on succulent beans at 0.10 part per million (ppm). This tolerance will expire and is revoked on June 30, 2003. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The silverleaf whitefly (SLW) is a relatively new pest, and has caused severe economic damage to various commodities nationwide. The larval instars and adults feed on the sap of bean plants, resulting in honeydew production which serves as a medium for fungal disease development, which hampers photosynthesis and renders pods unmarketable. Additionally, in late 1992, bean golden mosaic virus (BGMV) was first detected, although it's distribution was limited for several years. This virus is transmitted by the SLW. Recently, BGMV has become a more serious problem, believed to be the result of season-long build-up of the disease. This shift is a significant new development making BGMV a major pest in legume production in Florida. This trend is expected to continue unless an effective insecticide is available to control the SLW. EPA has authorized under FIFRA section 18 the use of pyriproxyfen on succulent beans for control of silverleaf whitefly in Florida. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of pyriproxyfen in or on succulent beans. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6). Although this tolerance will expire and is revoked on June 30, 2003, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on succulent beans after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether pyriproxyfen meets EPA's registration requirements for use on succulent beans or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of pyriproxyfen by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Florida to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for pyriproxyfen, contact the Agency's Registration Division at the address provided underFOR FURTHER INFORMATION CONTACT.

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of pyriproxyfen and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of pyriproxyfen in or on succulent beans at 0.10 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x10-6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for pyriproxyfen used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.510) for the combined residues of pyriproxyfen, in or on a variety of raw agricultural commodities. Section 18 emergency exemptions for use in/on cotton, citrus, almonds, and stone fruits have been approved. Section 3 permanent tolerances have been granted for cotton, citrus fruits, pome fruits, tree nuts, fruiting vegetables, and all foods in food handling establishments. Risk assessments were conducted by EPA to assess dietary exposures from pyriproxyfen in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. The acute dietary assessment is not required for pyriproxyfen because there were no effects that could be attributed to a single exposure (dose) in oral toxicity studies including the developmental toxicity studies in rats and rabbits.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992-nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues and 100% crop treated.

iii. Cancer. Pyriproxyfen has been classified as a Group E carcinogen; there is no evidence of carcinogenic potential. Therefore, a cancer risk assessment is not required.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for pyriproxyfen in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of pyriproxyfen.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and Screening Concentrations in Ground Water (SCI-GROW), which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to pyriproxyfen they are further discussed in the aggregate risk sections below.

Based on the PRZM/EXAMS and SCI-GROW models the EECs of pyriproxyfen for chronic exposures are estimated to be 0.11 ppb for surface water and 0.006 ppb for ground water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Pyriproxyfen is currently registered for use on the following residential non-dietary sites: Residential (indoor, non-food) products for flea and tick control. Formulations include contact sprays, emulsifiable concentrates, and impregnated materials (pet collars). With the exception of the pet collar uses, consumer use of pyriproxyfen typically results in short-term, intermittent exposures. Hence, chronic residential postapplication exposure and risk assessments were conducted to estimate the potential risks from pet collar uses.

The risk assessment was conducted using the following assumptions: Application rate of 0.58 mg ai/day (product label), average body weight for a 1 to 6 year old child of 10 kg, the active ingredient dissipates uniformly through 365 days (the label instructs to change the collar once a year), and 1% of the active ingredient is available for dermal and inhalation exposure per day. The assessment also assumes an absorption rate of 100%. This is a conservative assumption since the dermal absorption was estimated to be 10%.

4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether pyriproxyfen has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, pyriproxyfen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that pyriproxyfen has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Developmental toxicity studies. In the developmental study in rats, the maternal (systemic) NOAEL was 100 mg/kg/day, based on decreased body weight, body weight gain, food consumption and increased water consumption at the LOAEL of 300 mg/kg/day. The developmental (fetal) NOAEL was 300 mg/kg/day, based on increased skeletal variations and unspecified visceral variations at the LOAEL of 1,000 mg/kg/day.

In the developmental toxicity study in rabbits, the maternal (systemic) NOAEL was 100 mg/kg/day, based on abortions, soft stools, emaciation, decreased activity and bradypnea at the LOAEL of 300 mg/kg/day. The developmental (pup) NOAEL was 300 mg/kg/day, based on decreased viable litters at the LOAEL of 1,000 mg/kg/day.

3. Reproductive toxicity study. In the 2-generation reproductive toxicity study in rats, the maternal (systemic) NOAEL was 87/96 mg/kg/day for M/F, based on decreased body weights, body weight gains, and increased liver weight associated with histopathological findings in the liver at the LOAEL of 453/498 mg/kg/day for M/F. The developmental (pup) NOAEL was 87/96 mg/kg/day, based on decreased body weight on lactation days 14 and 21 at the LOAEL of 453/498 mg/kg/day. The reproductive NOAEL was 453/498 mg/kg/day HDT.

4. Prenatal and postnatal sensitivity. The toxicological data base for evaluating prenatal and postnatal toxicity for pyriproxyfen is complete with respect to current data requirements. There are no prenatal or postnatal toxicity comparisons for infants and children, based on the results of the rat and rabbit developmental toxicity studies and the 2-generation rat reproductive toxicity study.

5. Conclusion. Based on the above, the Agency concludes that reliable data support use of a 100-fold margin of exposure/uncertainty factor, rather than the standard 1,000-fold margin/factor, to protect infants and children.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water EECs. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + chronic non-dietary, non-occupational exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to pyriproxyfen in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of pyriproxyfen on drinking water as a part of the aggregate risk assessment process.

1. Acute risk. The acute dietary assessment is not required for pyriproxyfen because there were no effects that could be attributed to a single exposure (dose) in oral toxicity studies including the developmental toxicity studies in rats and rabbits.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pyriproxyfen from food will utilize 0.9% of the cPAD for the U.S. population, 1.6% of the cPAD for all infants <1 year old and 2.6% of the cPAD for children 1-6 years old. Chronic residential exposure to pyriproxyfen from pet collars is estimated to increase total pyriproxyfen exposure to infants and children only marginally. In addition, despite the potential for chronic dietary exposure to pyriproxyfen in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of pyriproxyfen in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2:

3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term residential exposure assessment is not required for pyriproxyfen due to the lack of significant toxicological effects observed.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term residential exposure assessment is not required for pyriproxyfen due to the lack of significant toxicological effects observed.

5. Aggregate cancer risk for U.S. population. Pyriproxyfen has been classified as a Group E carcinogen; there is no evidence of carcinogenic potential. Therefore, a cancer risk assessment is not required.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to pyriproxyfen residues.

Adequate enforcement methodology (example - gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no CODEX, Canadian, or Mexican Maximum Residue Limits (MRL) for pyriproxyfen on succulent beans.

Therefore, the tolerance is established for combined residues of pyriproxyfen in or on succulent beans at 0.10 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301165 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 5, 2001.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by the docket control number OPP-301165, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a time-limited tolerance under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

In the final rule published on January 12, 2001 in the Federal Register (66 FR 3148), we specified transition periods for those States with State plan amendments (SPAs) approved before the final rule effective date of March 13, 2001. In our March 13, 2001 letter to State Medicaid Directors, we clarified that state plan amendments submitted on or after the effective date of that final rule would be subject to the new requirements of that final rule. We further explained that we would disapprove any state plan amendment that is submitted on or after that date, including modification to existing state plans, that does not conform with the new upper payment limitations.

The State Medicaid Directors letter did not address the amendments pending CMS approval. After reviewing the legal and policy issues involved, the Administration now believes that each State's pending amendment should be reviewed under the criteria in place when it was submitted, and, for those submitted before March 13, 2001, the criteria before the January 12, 2001 final rule rather than applying the provisions of that rule. However, the Administration is also committed to phasing out the UPL loophole and assuring that tax dollars are spent properly. Absent modification of the UPL transition provisions, approval of these State plan amendments could trigger a 2-year transition period through September 30, 2002, which would have greater budget implications than anticipated.

On April 3, 2001, we published a proposed rule in the Federal Register (66 FR 17657) proposing to create a separate UPL transition period for State plan amendments that were submitted to us before March 13, 2001 but were approved on or after January 22, 2001. We proposed that these State plan amendments would qualify for a transition period that would end on the later of March 13, 2001 or 1 year after the approved effective date of each State plan amendment. With respect to pending UPL plans that are expansions of previously approved plans, we proposed that the separate transition period would only apply to the portion of spending under the pending plan that is above the amount that was previously approved.

The proposed rule did not include those State plan amendments that were actively (not deemed) approved after January 12, 2001 based on their compliance with the final rule of January 12, 2001. Because these amendments comply with the January 12, 2001 final rule, the amendments are not subject to the transition periods specified in the January 12, 2001 final rule. Also, as noted in the State Medicaid Directors letter of March 13, 2001, any State plan amendments submitted on or after March 13, 2001 would be reviewed and acted upon under the January 12, 2001 final rule. We would also treat any material change submitted on or after March 13, 2001 to a State plan amendment pending on that date as a new State plan amendment. We would not be able to approve such a submission under the UPL requirements in effect, and it would not be eligible for the new transition period.

We received 7 timely comments in response to the April 3, 2001 proposed rule. The majority of the comments were from State agencies, and associations representing hospitals, health care systems, and providers of long-term care, assisted living, and nursing facilities. We reviewed each comment and grouped like or related comments. The comments and our responses are summarized below.

Comment: Several commenters requested either this regulation be withdrawn or that State plan amendments submitted prior to March 13, 2001 and approved after January 22, 2001 receive the transition period as defined in the January 12, 2001 final UPL rule. Several of these commenters felt the rule was a retroactive application of policy. Two commenters pointed out that the impact on one State would be to reduce its transition period from September 30, 2002 to September 30, 2001. Another commenter felt it was unfair to change the rules in mid-stream on States that had submitted amendments prior to January 12, 2001. If we decline to withdraw this proposal, one commenter asked that States submitting plan amendments on or before January 12, 2001 be allowed to exceed the newly established payment limits until September 30, 2002, the rationale being that States did not receive official word until the rule was published on January 12, 2001.

Response: We do not agree with the request to withdraw this rule or to extend the full two-year transition period to States with pending (unapproved) amendments as of January 12, 2001 but we have altered the timing of the new transition period to ensure that it will not apply retroactively to any payments that may already have been made.

We note that States had clear and sufficient notice of an impending change in the UPL rules, and should have had no reasonable expectation of favorable treatment for unapproved amendments after the publication of the final rule. Therefore, the proposed shorter transition reflected an approach to balance our interest in curtailing the use of inappropriate Federal Medicaid funds with the States concerns about a shift in federal rules. When the final UPL regulation was issued on January 12, 2001, we did not state that pending State plan amendments would be approved. Thus, we do not believe States had a reasonable reliance on the expectation of a full transition period. Nevertheless, we were aware of the possibility that some States may have been adversely affected by the timing of the issuance of the final rule. Thus, we determined that we would approve amendments pending prior to the effective date (March 13, 2001) of the January UPL regulation but we announced that we would propose a shorter transition period for those amendments.

The duration of the proposed new transition period was not intended to apply retroactively to any payments. Because of the timing in issuing this final rule, we have lengthened the duration of the new transition period to ensure that this remains the case. The new transition period will not end until the later of: (1) One year from the initial effective date of the State plan provision; or (2) the effective date of this final rule.

As a result of this change, no State that qualifies for this new transition period will have its transition period expire prior to the effective date of this final rule. In addition, all such States will also have or have had at least 1 full year to make payments under their amendments, which was our intent in issuing the transition policies in the April 3, 2001 proposed rule.

Comment: One commenter asked for clarification that state plan amendments pending as of March 12, 2001 that do not increase spending levels at non-State, government owned hospitals would not be impacted by this rule.

Response: If the pending amendments do not increase spending, then the transition period provided by this rule would not be applicable.

Comment: Two commenters indicated that they were uncertain how the transition period in this final regulation would impact States that have relied on enhanced Medicaid funding for many years. One of these commenters was under the impression that this regulation would permit a window of two years for those States that had approved state plans before October 1, 1992 and did not submit amendments.

Response: A State's eligibility for one of the two longer transition periods set forth in the January 12, 2001 final UPL rule is not altered by this rule. What could be impacted is the maximum amount of excessive funding that is phased out over long periods of time. If an amendment pending on March 13 was approved after January 22, 2001, and the amendment had the effect of increasing the amount of spending that already exceeded the January 12, 2001 final UPL rule, then just the incremental increase provided by that amendment would be subject to the transition period in this rule.

Comment: One commenter recommended that only state plan amendments submitted to CMS on or after March 13, 2001, the effective date of the January 12, 2001 UPL regulation, be subject to this regulation. A second commenter similarly recommended this regulation apply only to amendments submitted after January 12, 2001.

Response: We do not agree with these comments. The purpose of providing any transition period is to help mitigate the effect the new upper payment limits may have in States which have relied on enhanced payments under the former regulations to leverage federal Medicaid dollars. By extending a grace period to amendments submitted after the March 13, 2001 effective date of the new upper payment limits, this recommendation would provide a transition period to spending situations where clearly there was no reliance when the new rules took effect. We similarly believe that any State that submitted an amendment after the January 12, 2001 publication date of the final rule arguably had no basis to expect the amendment would be approved or had any history of reliance on such spending.

Comment: One commenter stated that we did not respond adequately in the January 12, 2001 final rule to several comments submitted on the October 10, 2000 proposed rule. Another commenter expressed concerns over the provisions of the January 12, 2001 final rule.

Response: We believe that, in the January 12, 2001 final rule, we adequately responded to all comments submitted in response to the October 10, 2000 proposed rule. We do not think it is necessary or appropriate to further respond to those comments, or respond to comments on the provisions of the January 12, 2001 final rule, in this final rule.

For the reasons discussed in section III of this preamble, this final rule adopts the separate UPL transition period proposed in the April 3, 2001 proposed rule.

This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).

We have examined the impact of this final rule as required by Executive Order (EO) 12866, the Unfunded Mandates Act of 1995, and the Regulatory Flexibility Act (RFA) (Pub. L. 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($110 million or more in any one year). We consider this to be a major rule and we have provided an analysis below.

The estimates provided below are based on State-reported Federal fiscal year information submitted with State plan amendments and State expenditure information, where available. We have lowered our estimate of potentially impacted State plan amendments that may qualify for a transition period to 4. In the April 3, 2001 proposed rule, we had estimated that 11 State plan amendments may have qualified for the transition period provided by this rule. Our revised estimate is based on a better understanding of State spending made pursuant to the amendments that targeted payments to public providers.

Were these State plan amendments to be approved under the 2-year transition period, we estimate the increase in spending attributed to these amendments would total $1.0 billion over fiscal years 2001 and 2002 as a result of the two-year transition period ending on September 30, 2002. Subjecting these same state payment provisions to the new shorter transition periods provided by this final rule will result in .5 billion savings over the same period relative to the spending that could have occurred under transition 2-year transition period ending September 30, 2002.

The Regulatory Flexibility Act requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $5 million to $25 million (see 65 FR 69432) or less annually. For purposes of the RFA, all hospitals, nursing facilities, intermediate care facilities for the mentally retarded, and clinics are considered to be small entities. Individuals and States are not included in the definition of a small entity.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds.

We do not believe the shorter transition periods adopted in this final rule will have a significant impact on small entities, including small rural hospitals. Although the transition policy allows States to make higher payments to government providers than what otherwise would have been allowable under the rules that were effective on March 13, 2001, this flexibility is only available for one year. Therefore, we do not expect small entities to develop any reliance on these payments.

The Unfunded Mandates Reform Act of 1995 also requires (in section 202) that agencies perform an assessment of anticipated costs and benefits before proposing any rule that may result in a mandated expenditure in any one year by State, local, or Tribal governments, in the aggregate, or by the private sector, of $110 million. Because this final rule does not mandate any new spending requirements or costs, but rather provides for new transition periods, we do not believe it has any unfunded mandate implications.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct compliance costs on State and local governments, preempts State law, or otherwise has Federalism implications. We do not believe this final rule in any way imposes substantial direct compliance costs on State and local governments, or preempts or supersedes State or local law. However, we realize the reform of upper payment limits is an issue some States are very interested in. Therefore, in addition to providing States with an opportunity to comment on the proposed rule, we have tried to afford States ample opportunities to express their interest and concerns as we have moved forward in developing reforms.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

This is a synopsis of the Commission's Memorandum Opinion and Order, MM Docket No. 00-166, adopted August 15, 2001, and released August 24, 2001. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center (Room CY-A257), 445 Twelfth Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.

Regulations implemented under the authority of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas among the various domestic fishing categories, and General category effort controls (including time-period subquotas and RFDs) are specified annually as required under 50 CFR 635.23 (a) and 635.27 (a). The initial 2001 BFT fishing category quotas and General category effort controls were specified on July 13, 2000 (66 FR 37421, July 18, 2001).

Under § 635.23 (a)(4), NMFS may increase or decrease the daily retention limit of large medium and giant BFT over a range from zero (on RFDs) to a maximum of three per vessel to allow for maximum utilization of the quota for BFT. Based on a review of dealer reports, daily landing trends, and the availability of BFT on the fishing grounds, NMFS has determined that an increase of the daily retention limit for the first half of September is appropriate and necessary to allow full use of the September subquota. Therefore, NMFS adjusts the daily retention limit for September 1 through September 15 to two large medium or giant BFT per vessel. Additionally, under 50 CFR 635.23 (a)(4), NMFS has determined that adjustment of the RFD schedule is also necessary to allow full use of the September subquota. Consequently, NMFS must increase the daily BFT retention limit for certain previously designated RFDs. Therefore, NMFS adjusts the daily retention limit for September 2, 3, 5, 9, 10, and 12, 2001, to two large medium or giant BFT per vessel. NMFS has selected these days in order to give adequate advance notice to fishery participants and NMFS enforcement.

The intent of these adjustments is to allow for maximum utilization of the General category subquotas for the September fishing period specified under 50 CFR 635.27 (a) to achieve optimum yield in the General category fishery, to collect a broad range of catch-effort data for stock monitoring purposes, and to be consistent with the objectives of the HMS FMP. For these same reasons, NMFS adjusted the General category daily retention limit on several occasions for previously scheduled RFDs over the last two years (64 FR 42855, August 6, 1999; 64 FR 51079, September 21, 1999; 65 FR 46654, July 31, 2000; and 65 FR 54970, September 12, 2000).

While BFT catch rates have been slow so far this season, NMFS recognizes that catch rates tend to increase in the fall fisheries. In order to ensure that the September subquota is not filled prematurely and to ensure equitable fishing opportunities in all areas and for all gear types, NMFS is adjusting the General category daily retention limit only through September 15 and NMFS is not waiving all the RFDs previously scheduled for September. After September 15, the daily BFT retention limit for vessels fishing under the General category quota reverts to one fish per day on authorized fishing days. Additionally, the scheduled RFDs for September 16, 17, 19, 23, 24, 26, 30, and October 1 and 3, remain in effect. If catch rates continue to be low after September 15, daily retention limits may be increased and some or all of the remaining previously scheduled RFDs may be waived as well.

Under the implementing regulations at 50 CFR 635.27 (a)(7), NMFS has the authority to allocate any portion of the Reserve to any category quota in the fishery, other than the Angling category school BFT subquota (for which there is a separate reserve), after considering the following factors: (1) The usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock; (2) the catches of the particular category quota to date and the likelihood of closure of that segment of the fishery if no allocation is made; (3) the projected ability of the vessels fishing under the particular category quota to harvest the additional amount of BFT before the end of the fishing year; (4) the estimated amounts by which quotas established for other gear segments of the fishery might be exceeded; (5) effects of the transfer on BFT rebuilding and overfishing; and (6) effects of the transfer on accomplishing the objectives of the HMS FMP.

The 2001 annual BFT quota specifications previously issued under § 635.27 provide for a quota of 55 mt of large medium and giant BFT to be harvested from the regulatory area by vessels fishing under the Harpoon category quota. As of August 23, 2001, Harpoon category landings totaled approximately 48 mt, with 7 mt available for the remainder of the season.

After considering the factors for making transfers between categories and from the Reserve, NMFS has determined that 15 mt of the remaining 41.9 mt of Reserve should be transferred to the Harpoon category. Thus, the Harpoon category quota is adjusted to 70 mt for the 2001 fishing year.

Once the adjusted Harpoon category quota has been attained, the Harpoon category will be closed. Announcement of the closure will be filed with the Office of the Federal Register, stating the effective date of closure, and further communicated through the Highly Migratory Species Fax Network, the Atlantic Tunas Information Line, NOAA weather radio, and Coast Guard Notice to Mariners. Although notification of closure will be provided as far in advance as possible, fishermen are encouraged to call the Atlantic Tunas Information Line at (888) USA-TUNA or (978) 281-9305, to check the status of the fishery before leaving for a fishing trip.

This action is taken under 50 CFR 635.23(a)(4) and is exempt from review under Executive Order 12866.

The Atlantic shark fishery is managed under the Fishery Management Plan for Atlantic Tunas, Swordfish, and Sharks, and its implementing regulations found at 50 CFR part 635 issued under authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.). -

On June 26, 2001, NMFS announced in the Federal Register (66 FR 33918) that the LCS commercial quota for the second semi-annual 2001 fishing season was 697 metric tons (mt) dressed weight (dw). Additionally, NMFS announced that, based on past catch rates, the LCS fishery would close on August 31, 2001. As of July 31, 2001, approximately 331 mt dw, or 47 percent of the available quota, had been reported landed. Extending the season should ensure that eligible participants have an adequate opportunity to harvest the available quota. -

Commercial fishing for pelagic and small coastal sharks may continue until further notice. When quotas for these species are projected to be reached, NMFS will file notice of closure at the Office of the Federal Register.

This action is taken under 50 CFR part 635 and is exempt from review under Executive Order 12866.

The HMS FMP and its implementing regulations at 50 CFR part 635 establish catch quotas and, as applicable, fishing category and seasonal subquotas, for the North Atlantic and South Atlantic swordfish stocks. Under the FMP, these catch quotas are required to be consistent with recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT). Additionally, the implementing regulations require that, if total landings are above or below the applicable Atlantic swordfish quotas, the difference must be subtracted from, or added to, the following year’s quota for the specific management category, provided such quota adjustments are consistent with ICCAT recommendations. Landings reports for the directed fisheries for North and South Atlantic swordfish, and estimates of the incidental catch of North Atlantic swordfish, indicate that the allocations for the respective fisheries were not completely harvested during the 1999 fishing year (June 1, 1999 through May 31, 2000.)

Directed fishery landings and incidental catch of North Atlantic swordfish during the 1999 fishing year were reported to ICCAT to be 2896 metric tons (mt) whole weight, equivalent to 2177.5 mt dressed weight (dw). The 1999 fishing year quota, after adjustment for the previous year’s underharvest (65 FR 15873, March 24, 2000), was 2727.3 mt dw. Therefore, a total of 549.8 mt dw of unharvested swordfish quota may be carried over.

Under applicable regulations at 50 CFR 635.23 (c)(3), if total landings are above or below the specific North Atlantic swordfish annual quotas, they must be subtracted from, or added to, the following year’s quota. Further, any carryover adjustments to the annual North Atlantic swordfish directed fishery quota must be apportioned equally between the two semiannual periods. The ICCAT recommendation on rebuilding the North Atlantic swordfish stock does allow for such carryovers. Because the 2000 fishing year ended May 31, 2001, the carryover amount will be applied to the current fishing year (June 1, 2001 through May 31, 2002.)

A total of 249 mt dw of the unharvested 1999 quota is added to the base 2001 directed fishery quota of 2033.2 mt dw for an adjusted North Atlantic swordfish directed catch quota of 2282.2 mt dw. This adjusted annual quota is divided into 2 equal semiannual quotas of 1141.1 mt dw for the periods of June 1, 2001 through November 30, 2001 and December 1, 2001 through May 31, 2002. The remaining 300.8 mt dw of the unharvested 1999 fishing year quota is added to the base 2001 incidental catch quota of 300 mt dw for an adjusted North Atlantic swordfish incidental catch quota of 600.8 mt dw.

Directed fishery landings of South Atlantic swordfish during the 1999 fishing year were reported to ICCAT to be 51 mt whole weight, equivalent to 38.3 mt dw. The 1999 fishing year quota was set at 289 mt dw (64 FR 29090, May 28, 1999). Consequently, a total of 250.7 mt dw was unharvested at the end of the fishing year.

The ICCAT recommendation on allocating the total allowable catch of South Atlantic swordfish contains no provisions to adjust country-specific quotas for over or under harvests in prior years. Therefore, the U.S. quota for South Atlantic swordfish remains at the current level of 289 mt dw. There is no incidental catch quota for South Atlantic swordfish.

When final swordfish landings figures for the 2000 fishing year are available, NMFS will transfer any unharvested quota to the 2001 fishing year. Additionally, if NMFS estimates that U.S. fishermen discarded more than 320 mt ww of swordfish during the 2000 fishing year, the dressed weight equivalent of the amount by which that allowance is exceeded will be deducted from the 2001 fishing year landings quota, consistent with the ICCAT swordfish rebuilding recommendation and HMS regulations at 50 CFR 635.27 (c)(3)(iii). NMFS will publish the 2000 fishing year swordfish landings and dead discards estimates at a later date and will announce any required adjustments to the 2001 fishing year quotas in the Federal Register.

Under the swordfish limited access program established under the 1999 HMS FMP and implemented by regulations at 50 CFR 635.16, NMFS has issued incidental catch permits. All swordfish catch by vessels so permitted are applied to the incidental catch quota as required by regulations at 50 CFR 635.27 (c). In past years, only a fraction of the incidental catch quota has been landed and NMFS has received comments requesting reallocation of a portion of the incidental catch quota to the directed fishery category. While under current regulations such reallocation is possible through an inseason quota adjustment, a permanent reallocation could reduce the potential for closure of the directed fishery mid-season. NMFS is currently evaluating the need for reallocation and may address this issue in a future rulemaking.

At the 2000 meeting of ICCAT, Japan indicated that it had exceeded its annual allocation of North Atlantic swordfish, due to higher than anticipated incidental catch rates of swordfish in its bigeye tuna fishery. This problem is difficult to address, because swordfish are not a target species and overharvest of the quota has forced Japanese fishermen to discard all swordfish, dead or alive. At the ICCAT meeting, the United States agreed to assist Japan in its efforts to comply with the catch allocation provisions of the swordfish rebuilding program by transferring to Japan a total of 400 mt whole weight (300.8 mt dw) of the U.S. North Atlantic swordfish quota for the 2001 fishing year. In order to accomplish this transfer, NMFS will have to reserve a portion of the 2001 North Atlantic swordfish quota. This reserve quota will be proposed in an upcoming rulemaking and the public will be provided with an opportunity to comment.

This action is taken under 50 CFR 635.27 (c). This action is exempt from review under Executive Order 12866.

The Northwest Regional Administrator, NMFS (Regional Administrator), determined that the modification of the open periods and limited retention regulation for the commercial fishery from the Queets River, WA, to Cape Falcon, OR, was justified, given the relative catch rate of chinook and coho. The open period for the fishery was modified to open for 10 days, starting August 3, 2001, and closed at midnight on August 12, 2001, with a limited retention regulation of 100 chinook per boat for this open period. Modification of fishing seasons is authorized by regulations at 50 CFR 660.409(b)(1)(i). Modification of the species that may be caught and landed during specific seasons, and the establishment or modification of limited retention regulations, is authorized by regulations at 50 CFR 660.409(b)(1)(ii). -

In the 2001 annual management measures for ocean salmon fisheries (66 FR 23185, May 8, 2001), NMFS announced that the commercial fishery for all salmon in the area from Queets River to Cape Falcon would open the earlier of the day following closure of the U.S.-Canada Border to Leadbetter Pt. July troll fishery or July 28, but not before July 20, through the earliest of September 30 or the overall chinook quota (preseason 6,000-chinook guideline) or a 63,000 marked-coho guideline. The fishery was scheduled to run continuously until 75 percent of either guideline was caught; it would then revert to a cycle of 4 days open/3 days closed. The annual measures also indicated that trip limits, gear restrictions, and guidelines may be instituted or adjusted inseason. -

The U.S.-Canada Border to Leadbetter Pt. July troll fishery was closed in an inseason action on July 9, 2001, at 2359 hours l.t.(66 FR 38573, July 25, 2001). Therefore, the commercial fishery for all salmon from Queets River to Cape Falcon opened on July 20, 2001. -

NMFS announced a modification of the weekly opening period and the addition of a limited retention regulation for the commercial fishery from the Queets River, WA, to Cape Falcon, OR, to follow a cycle of 4 days open/3 days closed, and a limit of 65 chinook per open period per boat effective 0001 hours l.t., July 20, 2001 (66 FR 45634, August 29, 2001). The Regional Administrator consulted with representatives of the Pacific Fishery Management Council (Council), Washington Department of Fish and Wildlife (WDFW), and Oregon Department of Fish and Wildlife (ODFW) regarding the inseason action by conference call on July 18, 2001. The states indicated that there was a higher than projected chinook/coho catch ratio. The modifications to the season were adopted to avoid closing the fishery early because of the chinook quota, thus precluding the opportunity to catch available marked hatchery coho salmon. -

There was a subsequent conference call on July 26, 2001, following the first open period, to assess the status of the fishery. The chinook/coho catch rates and effort data in the first open period indicated that no further season modifications were necessary for the second 4-day opening (July 27-30, 2001). -

After the second open period, the Regional Administrator again consulted with representatives of the Council, WDFW, and ODFW by conference call on August 1, 2001, regarding the fishery. The chinook/coho catch rates and effort data indicated that the availability of coho was increasing in the area. The states recommended that the season be modified to open for 10 days, reopening August 3, 2001, and closing at midnight on August 12, 2001, with a limit of 100 chinook per boat for the open period. All other restrictions that apply to this fishery, as announced in the 2001 annual management measures for ocean salmon fisheries and subsequent inseason actions, remain in effect. -

The Regional Administrator consulted with representatives of the Council, WDFW, and ODFW regarding the inseason action by conference call. The best available information on August 1, 2001, indicated that the catch/effort data and projections supported the commercial fishery season modifications. The states will manage the fisheries in state waters adjacent to the areas of the exclusive economic zone in accordance with these Federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice to fishermen of the adjustments in the area from Queets River to Cape Falcon effective 0001 hours l.t., August 3, 2001, was given prior to the effective date by telephone hotline number 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz. -

Because of the need for immediate action for the season modifications for the area from Queets River to Cape Falcon, NMFS has determined that good cause existed for this notification to be issued without affording a prior opportunity for public comment because such notification would be unnecessary, impracticable, and contrary to the public interest. Moreover, because of the immediate need to modify a season because of estimates of effort and catch, the Assistant Administrator for Fisheries, NOAA finds, for good cause, under 5 U.S.C. 553(d)(3), that delaying the effectiveness of this rule for 30 days is impracticable and contrary to public interest. -

This action does not apply to other fisheries that may be operating in other areas. -

This action is authorized by 50 CFR 660.409 and 660.411 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The Pacific halibut PSC limit for groundfish included in the other hook-and-line fishery, which is defined at § 679.21 (d)(4)(iii)(C), was established by the Final 2001 Harvest Specifications and Associated Management Measures for the Groundfish Fisheries Off Alaska (66 FR 7276, January 22, 2001) and subsequent adjustments (66 FR 17087, March 29, 2001 and 66 FR 37167, July 17, 2001) as 290 metric tons (mt).

The other hook-and-line fishery includes all groundfish except sablefish in the GOA and demersal shelf rockfish in the Southeast Outside District.

In accordance with § 679.21 (d)(7)(ii), NMFS is prohibiting directed fishing for groundfish other than sablefish in the GOA or demersal shelf rockfish in the Southeast Outside District by vessels using hook-and-line gear.

Maximum retainable bycatch amounts may be found in the regulations at § 679.20 (e) and (f).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action because the Pacific halibut hook-and-line PSC limit has been reached constitutes good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553 (b)(3)(B) and 50 CFR 679.20 (b)(3)(iii)(A), as such procedures would be unnecessary and contrary to the public interest. Similarly, the need to implement these measures in a timely fashion because the Pacific halibut hook-and-line PSC limit has been reached constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553 (d), a delay in the effective date is hereby waived.

This action is required by § 679.21 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP at subpart H of 50 CFR part 600 and CFR part 679. -

The Atka mackerel TAC for non-jig gear in the Eastern Aleutian District and the Bering Sea subarea was specified as 7,143 metric tons (mt) (66 FR 7276, January 22, 2001). See § 679.20(a)(8)(ii). -

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the TAC for non-jig gear Atka mackerel in the Eastern Aleutian District and the Bering Sea subarea will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 6,943 mt, and is setting aside the remaining 200 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance soon will be reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the Eastern Aleutian District and the Bering Sea subarea of the BSAI.

Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action to prevent exceeding the 2001 TAC of Atka mackerel in the Eastern Aleutian District and the Bering Sea subarea of the BSAI constitutes good cause to waive the requirement to provide prior notice opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(3)(B) and 50 CFR 679.20(b)(3)(iii)(A), as such procedures would be unnecessary and contrary to the public interest. Similarly, the need to implement these measures in a timely fashion to prevent exceeding the 2001 TAC of Atka mackerel in the Eastern Aleutian District and the Bering Sea subarea of the BSAI constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.