This final rule expands the Board to 23 permanent members by adding two Board Member positions. With this change, the Board will consist of a Chairman, two Vice Chairmen, and twenty other members. This change is necessary to maintain an effective, efficient system of appellate adjudication in light of the Board's increasing caseload. This rule amends 8 CFR part 3 and 28 CFR part 0 to reflect these changes in the Board's organization.

Compliance with 5 U.S.C. 553 as to notice of proposed rulemaking is not required because this rule relates to agency organization, procedure, and practice, and a delayed effective date is unnecessary because it does not substantially affect the rights or obligations of non-agency parties. See 5 U.S.C. 553(b)(a), (d)(3).

The Attorney General, in accordance with 5 U.S.C. 605(b), has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Department of Justice has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f). Accordingly, this rule has not been reviewed by the Office of Management and Budget.

This rule will 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. Therefore, in accordance with section 6 of Executive Order 13132, the Department of Justice has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

This action pertains to agency organization, practice, and procedure and does not substantially affect the rights or obligations of non-agency parties and, accordingly, is not a “rule” as that term is used by the Congressional Review Act. (Subtitle E of the Small Business Regulatory Enforcement Act of 1996 (SBREFA). Therefore, the reporting requirement of 5 U.S.C. § 801 does not apply.

We try to write clearly. If you can suggest how to improve the clarity of these regulations, call or write Charles Adkins-Blanch, General Counsel, Executive Office for Immigration Review, Suite 2400, 5107 Leesburg Pike, Falls Church, VA 22041; telephone (703) 305-0470.

On June 29, 2001 (66 FR 34523), the NRC published in the Federal Register a direct final rule amending its regulations in 10 CFR 72 by revising the Standardized NUHOMSTM-24P and -52B cask system listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 3 to Certificate of Compliance Number 1004. Amendment No. 3 will modify the present cask system design to add the -61BT dry storage canister which is the storage portion of a dual purpose cask design intended to both store and transport spent fuel. In the direct final rule, NRC stated that if no significant adverse comments were received, the direct final rule would become final on the date noted above. The NRC received a number of comments requesting an extension to the public comment period, but no supporting rationale for the extension request was provided. Some of these commenters also provided additional comments with their request. The NRC has evaluated these additional comments and determined that none of them were significant and adverse to warrant withdrawal of the direct final rule, or supported a need for an extension of the comment period.

Therefore, the request for extension is denied and the direct final rule will become effective as scheduled, September 12, 2001.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 777-200 series airplanes was published in the Federal Register on June 27, 2001 (66 FR 34130). That action proposed to require inspections for cracking of the web of the horizontal and sloping pressure decks of the fuselage and certain stiffener splice angles and stiffener end fittings, and repair, if necessary. That action also proposed to provide an optional preventative modification, which ends the repetitive inspections.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 93 Model 777-200 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 27 airplanes of U.S. registry will be affected by this AD, that it will take approximately 36 work hours per airplane to accomplish the required inspections, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $58,320, or $2,160 per airplane, per inspection cycle.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

In response to requests from members of the public, the Department has decided to reopen and extend the public comment period for the interim final rule it published on May 25, 2001 (66 FR 28948). The comment period closed on August 23, 2001, and is being reopened (retroactive to that date) and extended through September 24, 2001. In the interim final rule, which became effective on July 24, 2001, the Department promulgated regulations governing its administration of the Energy Employees Occupational Illness Compensation Program Act (EEOICPA), Pub. L. 106-398, 114 Stat. 1654, 1654A-1231 (October 30, 2000). The EEOICPA established a compensation program to provide a lump sum payment of $150,000 and medical benefits as compensation to covered employees suffering from designated illnesses incurred as a result of their exposure to radiation, beryllium, or silica while in the performance of duty for the Department of Energy and certain of its vendors, contractors and subcontractors. This legislation also provided for payment of compensation to certain survivors of these covered employees, as well as for payment of a smaller lump sum ($50,000) to individuals (who would also receive medical benefits), or their survivor(s), who were determined by the Department of Justice to be eligible for compensation under section 5 of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note).

The Department's description of the United States Marshals Service is being revised in order to describe fully the authority delegated to the Director of the Service pursuant to 18 U.S.C. 3521. This description is contained in a new paragraph designated as § 0.111b.

This rule relates to a matter of agency management or personnel, and is therefore exempt from the usual requirements of prior notice and comment and a 30-day delay in effective date. See 5 U.S.C. 553(a)(2).

The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. A Regulatory Flexibility Analysis was not required to be prepared for this final rule because the Department was not required to publish a general notice of proposed rulemaking for this matter.

This rule has been drafted and reviewed in accordance with section 1(b) of Executive Order 12866, Regulatory Planning and Review. The rule is limited to agency organization, management and personnel as described by section (3)(d)(3) of Executive Order 12866 and, therefore, is not a “regulation” or “rule” as defined by that Executive Oorder. Accordingly, this rule has not been reviewed by the Office of Management and Budget.

This rule will 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. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This action pertains to agency management, personnel, and organization and does not substantially affect the rights or obligations of non-agency parties. Accordingly, it is not a “rule” for purposes of the reporting requirement of 5 U.S.C. 801.

We try to write clearly. If you can suggest how to improve the clarity of these regulations, call or write Gerald M. Auerbach, Senior Litigation Counsel, at the address and telephone number listed above.

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 Coast Guard received the request for special local regulations with insufficient time to publish a NPRM, allow for comments, and publish a final rule prior to the event on September 22 and 23, 2001. Because of the dangers inherent with high-speed boat races, 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 New Jersey Performance Power Boat Club will sponsor the Atlantic City APBA Grand Prix on September 22 and 23, 2001. The event will consist of 200 to 300 offshore powerboats conducting high-speed competitive races on the waters of the Atlantic Ocean adjacent to Atlantic City, New Jersey. 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 Atlantic Ocean adjacent to Atlantic City, New Jersey. The regulated area includes a 3-mile long section of the Atlantic Ocean south of Absecon Inlet, extending approximately 300 yards out from the shoreline. The temporary special local regulations will be enforced from 11:30 a.m. to 3:30 p.m. eastern time on September 22 and 23, 2001, and will restrict general navigation in the regulated area during the races. Except for participants in the Atlantic City APBA Grand Prix 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 Atlantic Ocean 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 Atlantic Ocean during the event.

Although this regulation prevents traffic from transiting a portion of the Atlantic Ocean 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 (Public 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 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.

Pursuant to 5 U.S.C. 553, a notice of proposed rulemaking (NPRM) was not published for this regulation. Good cause exists for not publishing a NPRM and for making this regulation effective in less than 30 days after publication in the Federal Register. Conclusive information about dredging operations requiring explosive detonations on the Chelsea River was not provided to the Coast Guard until August 6, 2001, making it impossible to draft or publish a NPRM or a final rule 30 days in advance of its effective date. Any delay encountered in this regulation's effective date would be unnecessary and contrary to public interest since immediate action is needed to protect the maritime community from hazards created by detonating explosives in the Chelsea River. General permissions to enter the safety zone will be given via local notice to mariners and marine information broadcasts during periods when the Captain of the Port determines it is safe to transit the zone. Detonations will only take place approximately one to three times per day, Monday through Saturday, during daylight hours of the effective period. The safety zone should have negligible impact on vessel transits because general permissions to transit the zone will be given when appropriate, the rule is for a limited time period, and vessels are not precluded from using any portion of the waterway outside the safety zone.

This regulation establishes a temporary safety zone for the Chelsea River Blasting during daylight hours from August 13, 2001, through September 22, 2001 in Boston, MA. This blasting is being conducted on the eastern bank of the Chelsea River to clear an area of rock and increase the depth of water to 40 feet. The safety zone temporarily closes all waters of the Chelsea River three hundred (300) yards around the Great Lakes dredge barge while it is involved in the detonation of explosives in the Chelsea River turning basin, at a location on the eastern bank approximately 1000 yards north of the Chelsea Street Bridge. Detonations shall occur approximately one to three times per day, Monday through Saturday, during daylight hours of the effective period. Entry into or movement within this portion of the Chelsea River during the effective period is prohibited without Captain of the Port authorization. The safety zone is needed to protect the maritime community from the hazards caused by the detonations of explosives in the Chelsea River. The safety zone should have negligible impact on vessel transits because the Captain of the Port General will grant general permissions to enter the safety zone during periods when the COTP determines it is safe to transit the zone. These general permissions will be communicated via local notice to mariners and marine information broadcasts.

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).

The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary.

Although this regulation prevents traffic from transiting a portion of the Chelsea River, the effect of this regulation will not be significant for several reasons: The safety zone should have negligible impact on vessel transits because the Captain of the Port will grant general permissions to enter the safety zone during periods when the COTP determines it is safe to transit the zone. Detonations will only take place one to three times per day, Monday through Saturday, during daylight hours of the effective period. Moreover, vessels are not precluded from using other portions of the Chelsea River outside the safety zone.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard 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 a portion of the Chelsea River between 9 a.m. on August 13, 2001 and 7 p.m. on September 22, 2001. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: the safety zone is limited in duration, and the Captain of the Port will grant general permissions to enter the safety zone during periods when the COTP determines it is safe to transit the zone.

Due to the short notice of the need for this regulation the Coast Guard did not have time to assist small entities under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121).

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).

The Coast Guard analyzed this rule under Executive Order 13132 and has determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule would not impose an unfunded mandate.

This rule would not effect 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.

The Coast Guard 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 pose 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. A rule with tribal implications has 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.

The Coast Guard considered the environmental impact of this rule and concluded that, under figure 2-1, (34)(g), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.

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.

This rule was proposed in a notice of proposed rulemaking published at 65 FR 80810 on December 22, 2000. Background information on this rule may be found in that notice.

Comment: Proposed section 104.23 purports to prohibit “employees” (which include ex-employees) from giving expert testimony regarding “Office information, subjects, or activities.” In patent infringement actions, it is common for a party to put up an ex-USPTO employee (often a very senior employee, such as a former Commissioner) as an expert witness to explain the procedures of the USPTO to the judge or jury. It is unclear that the Office has the authority to prohibit ex-employees from so testifying, but in any event the use of ex-USPTO employees as expert witnesses on such general subjects should not be prohibited. If this is not the intent of proposed section 104.23 then the rule should be clarified.

Response: Under the provisions of 37 CFR 104.21(b)(2), former employees are excluded from the scope and purpose of Subpart C with respect to matters in which the former employee did not participate personally while at the Office. In addition, under 37 CFR 104.23(a)(2), the General Counsel may authorize an employee to give expert testimony in exceptional circumstances and purpose. Consequently, the rule does not prohibit former employees from giving expert testimony in appropriate circumstances.

Comment: Generally, it is not clear that the Office should preclude an investigation into whether inequitable conduct or fraud on the Office had been practiced in a given patent application. Interested parties (e.g., the defendant in an infringement action) should be permitted to inquire into certain events if fraud is alleged. For instance, if an exhibit had been shown at an interview and it were alleged that the exhibit (which had since been destroyed) had fraudulently represented the invention, there would be no way to obtain that information absent interviewing the Examiner—the interview summary sheet would not be effective here. Permitting such discovery would impose only a slight burden on the Office and would not be inconsistent with the policies discussed in the notice of the proposed rule. Moreover, to the extent that permitting such inquiry would assist in uncovering and deterring fraud and inequitable conduct, other important policies would be furthered. It may be appropriate to treat requests for such discovery under proposed section 104.3 (relating to exceptional circumstances). If such is the case, then the Office is requested to respond to this comment by indicating that lawsuits in which fraud/inequitable conduct issues are raised are sufficiently “exceptional” that requests for discovery into such allegations will be favorably considered (or at least deemed appropriately raised) under this rule.

Response: The rule does not prohibit a party from calling an employee as a fact witness. The rules do prevent inquiry into an examiner's state of mind. For example, subjective state of mind of the employee is irrelevant to an inequitable-conduct inquiry. If fact testimony proves to be inadequate, then the parties may avail themselves of the provisions of section 104.3, which provides that the General Counsel may waive or suspend the rules in extraordinary circumstances.

Comment: The application of the Department of Commerce (“DOC”) rules and the proposed USPTO rules to former employees is unnecessary to protect the legitimate interests of the Office. The existing USPTO rules of practice preclude former employees from taking any action which gives an appearance of impropriety. 37 CFR 10.110 and 10.111. Those rules give adequate protection to the USPTO for voluntary testimony by former employees concerning matters the former employees worked on while employed by the USPTO. Friedman v. Lehman, 40 USPQ2d 1206 (D.D.C. 1996).

Response: Part 10 only applies to registered patent practitioners and trademark attorneys practicing before the USPTO. If the former employee is not practicing before the USPTO, Part 10 does not apply. Thus, this proposed rule is intended to apply to all employees, not just those employees who practice before the USPTO. Indeed, some former employees do not practice before the Office. Further, Part 10 is intended to protect the public from improper conduct by practitioners, while these rules are intended in part to protect the USPTO's deliberative or otherwise confidential information from unauthorized disclosure.

Comment: If, however, the USPTO does adopt rules applying to former employees, it should be made clear that such rules would not have retroactive effect, so that activity that was considered proper when performed would not now become improper and subject a former employee to some type of disciplinary action. In this regard, it would be desirable to clarify what relationship any violation of the proposed rules would have to misconduct under the disciplinary rules of 37 CFR Part 10.

Response: The rules are not given retroactive effect. Under the provisions of 37 CFR 10.23, misconduct potentially could include the actions of an employee who provided testimony that was not authorized by the rules. This issue, however, is within the jurisdiction of the Director, Office of Enrollment and Discipline, and is not properly addressed in these rules. Note, however, that the DOC rules have explicitly applied to former employees since 1995.

Comment: In addition, consideration should also be given to the effect which the current DOC rules will have with respect to former USPTO employees which proposed § 104.21 (b) (2) would exempt. Such former USPTO employees are also former DOC employees and the proposed rules do not appear to address this question.

Response: While USPTO is a separate agency within the DOC, only the USPTO rules are applicable to current and former USPTO employees with respect to testimony related to official USPTO business. Of course, a former USPTO employee who is also a current or former employee of another DOC organization would be subject to the DOC rules with respect to matters related to that organization. Moreover, the exception provided by § 104.21(b)(2) for former employees, is consistent with DOC policy regarding similar testimony of former DOC employees.

Comment: With respect to information sought by subpoena addressed in § 104.22, the USPTO should be required to appear if it opposes a disclosure of information and should not be able to shift that obligation to the former employee. Thus, the commenter opposes the proposed rules insofar as they would enable the USPTO to sanction a former employee for failure to comply with proposed § 104.22(f) when the Office has been properly notified but does not send legal counsel to appear and contest the subpoena on behalf of the employee.

Response: The purpose of § 104.22(f) is not to “shift that obligation to the former employee.” The USPTO intends to seek Department of Justice representation for former employees when the General Counsel makes a determination under the rules that an employee should not comply with a subpoena. In those cases where compliance with a subpoena is commanded before Department of Justice representation can be arranged, the employee must, nevertheless, refuse to comply. In order to minimize the occurrence of this event, § 104.22(a) requires employees to immediately notify the General Counsel when they are served with a subpoena.

Comment: It is noted that unlike the DOC rules which define employee as including “current or former employees” (15 CFR 15.12(f)) and then consistently use the term “employee”, the proposed rules use the same definition as the DOC rules but then make a reference to “former employee” in § 104.21(b)(2). While this appears appropriate for § 104.21(b)(2), other sections seem to apply solely to a current employee but are not so limited. We believe that such potential ambiguities will render application of the rules unclear.

Response: The term “employee” is consistently used in the rules to refer to both current and former employees. The use of the term “former employee” in § 104.21(b)(2), which is the only section that does not apply to both current and former employees, does not create ambiguity.

Comment: The USPTO should clarify that proposed section 104.21(b)(2), which prohibits former employees from testifying as to matters in which they “participate[d] personally,” does not prohibit former high ranking USPTO officials or employees from providing expert testimony in court on USPTO procedures during the period when the official or employee was working at the USPTO.

Response: The term “participated personally” is derived from 18 U.S.C. 207(a) and is used here in keeping with the interpretation the Office of Government Ethics has given the phrase at 5 CFR 2637.201(d).

A new section 104.4 has been added to clarify that nothing in the rules waives or limits any requirement under the Federal Rules of Criminal or Civil Procedure. Subsection 104.24(f) has been modified to clarify the Office's duty to seek Department of Justice representation for the employee involved when the General Counsel makes a decision not to comply with a subpoena. In addition, other minor changes have been made to the wording of the proposed rule.

This rule is not significant under Executive Order 12866.

This final rule involves information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The collection of information involved in this final rule has been reviewed and previously approved by OMB under control number 0651-0046. The USPTO is not resubmitting an information collection package to OMB for its review and approval because the changes in this final rule do not affect the information collection requirements associated with the information collection under OMB control number 0651-0046.

In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), USPTO has certified that this rule will not have a significant impact on a substantial number of small businesses. The factual basis for this certification was provided in the Notice of Proposed Rulemaking published on December 22, 2000, 65 FR 80810. The factual basis for the certification remains the same for this final rule, and therefore, need not be repeated.

This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (August 4, 1999).

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

On July 20, 2001, submitted Rule 8-51 was found to meet the completeness criteria in 40 CFR Part 51 Appendix V, which must be met before formal EPA review. Completeness was not required for rules like 443.1 that were submitted prior to 1988.

We finalized a limited approval and limited disapproval of BAAQMD Rule 8-51 on November 4, 1999 (64 FR 60109). The limited approval portion of that rulemaking incorporated BAAQMD Rule 8-51 into the federally enforceable SIP and the limited disapproval portion of that rulemaking triggered sanctions and FIP clocks under sections 179(a) and 110(c) of the CAA. There are no previous versions of SCAQMD Rule 443.1 in the SIP. SCAQMD Rule 443.1 was originally proposed for approval on September 14, 1988 (53 FR 35528). Although we received no adverse comments, we are reproposing to approve the rule due to the length of time that has elapsed since our original action.

The amendments to Rule 8-51 adopted by the BAAQMD on May 2, 2001 and submitted to the EPA on May 31, 2001 were intended to address deficiencies in the version of Rule 8-51 adopted on January 7, 1998. SCAQMD Rule 443.1 was adopted to institute labeling requirements for materials containing VOCs. The TSDs have more information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas (see section 182(a)(2)(A)), and must not relax existing requirements (see sections 110(l) and 193). The BAAQMD and SCAQMD regulate ozone nonattainment areas (see 40 CFR part 81), so BAAQMD Rule 8-51 and SCAQMD Rule 443.1 must fulfill RACT.

Guidance and policy documents that we used to define specific enforceability and RACT requirements include the following:

1. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987.

2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D of November 24, 1987 Federal Register Notice,” (Blue Book), notice of availability published in the May 25, 1988 Federal Register.

3. The State of California Air Resources Board's Determination of Reasonably Available Control Technology (RACT) and Best Available Retrofit Control Technology (BARCT) for Adhesives and Sealants, December 1998.

We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The TSDs have more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by October 12, 2001, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on November 13, 2001. This will incorporate these rules into the federally enforceable SIP and will permanently terminate all sanctions and FIP clocks associated with our November 1999 action relating to Rule 8-51.

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Table 2 lists some of the national milestones leading to the submittal of these local agency VOC rules.

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 32111, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (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 (Public Law 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 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 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 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. section 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. section 804(2).

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 13, 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 may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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 the Federal 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_180/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-301163. 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 tolerances for residues of the insecticide bromoxynil, 3,5-dibromo-4-hydroxybenzonitrile, in or on timothy, hay at 0.50 part per million (ppm) and timothy, forage at 0.10 ppm. These tolerances will expire and are 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 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.

On May 4, 2001, the Nevada Department of Agriculture availed themselves of the authority to declare a crisis exemption for use of bromoxynil in fields planted with both timothy and alfalfa to control weeds. Very recent overplanting of aging alfalfa fields with timothy revealed a problem with weed control in that no registered herbicides are available for use on alfalfa and timothy that do not damage the other crop. Bromoxynil, which is registered for use on alfalfa, does not damage timothy. The crisis declaration was made because alfalfa growth had reached a point where applications would be ineffective if done any later in the season. EPA has authorized under FIFRA section 18 the use of bromoxynil on timothy for control of weeds in Nevada.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of bromoxynil in or on timothy, hay and timothy, forage. 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 these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are 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 timothy, hay and timothy, forage 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 these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether bromoxynil meets EPA's registration requirements for use on timothy or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of bromoxynil 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 Nevada 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 bromoxynil, contact the Agency's Registration Division at the address provided under FOR 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 bromoxynil and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for residues of bromoxynil in or on timothy, hay at 0.50 ppm and timothy, forage 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 intraspecies 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 x 10- 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 bromoxynil 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 180.324) for the residues of bromoxynil, in or on a variety of raw agricultural commodities including alfalfa, barley, corn, flax, garlic, mint, oats, onions, rye, sorghum, wheat, and cotton. Tolerances have also been established on fat, meat, and meat-by-products of cattle, goats, hogs, horses, poultry, and sheep as well as eggs and milk. Risk assessments were conducted by EPA to assess dietary exposures from bromoxynil in food as follows.

Bromoxynil is currently registered for use on alfalfa. The aggregate risks associated with the use of bromoxynil on alfalfa have been assessed previously (Reregistration Eligibility Decision (RED) document, Decmeber 1998). No residue data are available for bromoxynil on timothy. As the use directions for timothy-alfalfa stands are the same as for alfalfa alone, the state has proposed to translate the existing residue data for alfalfa (a member of Crop Group 18, Nongrass Animal Feeds) to timothy (a member of Crop Group 17; Grass Forage, Fodder and Hay). This translation would generally not be possible as the timothy, forage tolerance would be based on 0-day preharvest interval (PHI) data whereas the PHI for alfalfa, forage is 30 days. However, as the cultural practices for timothy-alfalfa stands is the same as that for alfalfa alone, for the emergency exemption only, the Agency is willing to translate the existing alfalfa residue data to timothy. Based upon the alfalfa residue data, the following tolerances are thus appropriate for timothy, hay at 0.50 ppm and timothy, forage at 0.10 ppm.

There are no human food items associated with timothy and therefore, the use of bromoxynil on timothy will not increase the potential for secondary residues in livestock (since the residues in timothy will not exceed those on alfalfa, a more significant feed item), the dietary risk associated with bromoxynil will not be effected by this use. The potential for residues in drinking water will not be effected as the use rate for timothy-alfalfa stands is the same as for alfalfa alone. Thus, revised risk assessments were not conducted for this action. The information discussed below was previously discussed in the December 1998 RED document.

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. In 1998, an acute (probabilistic) dietary analysis including the cotton use was performed by Novigen Sciences, Inc. for Rhone Poulenc. The assessment used the consumption data from the USDA 1989-1992 nationwide Continuing Survey of Food Intakes by Individuals (CSFII).

The acute dietary risk assessment was conducted as a probabilistic risk assessment, assuming single day exposure. In the assessment, each person-day of food consumption was matched with randomly selected residue values for this assessment from field trails submitted in support of the chemical. Percent crop treated data were included in the assessment as zeroes to account for portions of the crop to which bromoxynil was not applied. This process was repeated one thousand times for each person-day in consumption data base. The assessment assumed that the treated commodities were evenly distributed in the food supply. Secondary residues in meat and milk from consumption of treated feed items were included in the form of a probabilistic assessment, varying residues in the diet in accordance with the data from the field trials. The assumptions for the dietary exposure were reviewed and found to be acceptable. The assessments assumed that 10% of the cotton crop would be treated.

Anticipated residues in blended commodities (such as grains, cottonseed and mint oil) were used, without an adjustment for percent crop treated; however, tolerance level residues were used for onions, garlic, fat, meat by-products, and meat of cattle, goats, hogs, horses, sheep, and poultry, and eggs. Milk is a blended commodity, and therefore an anticipated residue was used.

ii. Chronic/cancer exposure. In conducting this chronic dietary risk assessment the Dietary Risk Evaluation System (DRES) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Field trial residues in raw agricultural commodities (RACs) consumed by people were nondetectable; anticipated residues were based on ½ the limit of quantitation (LOQ), and were further refined by percent crop treated data. Field trial residues from all forages (i.e., sorghum, wheat, oat, corn, alfalfa), and all hays were averaged, and the additional refinement for percent crop treated was applied. Although forages and hays contained detectable bromoxynil residues, the averages used were significantly lower than tolerance-level residues.

The contribution of cotton gin products (gin trash) to the dietary burden for ruminants was assumed to be 5% of the diet for beef cattle and 1% for dairy cattle. It was assumed that 10% of cotton was treated. The only commodities which contribute significantly to exposure to bromoxynil and/or DBHA in the diet for the general U.S. population (or any subpopulation) are meat, milk, poultry, and eggs, based on secondary residues resulting from consumption of livestock feed items.

iii. Anticipated residue and percent crop treated information. Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a Data Call-In for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings:

• Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue.

• Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows: 10% of the cereal grains (wheat, corn, oats, barley, rye, sorghum, including processed commodities) treated; 62% of onions treated; 100% garlic treated; 71% of the peppermint and spearmint treated, and 10% of the cotton treated. Refer to the December 1998 RED docucment for additional information.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which bromoxynil may be applied in a particular area.

2. Dietary exposure from drinking water—i. Ground water. Bromoxynil octanoate does not exhibit the mobility or persistence characteristics of pesticides that are normally found in ground water. Bromoxynil phenol (which bromoxynil octanoate readily degrades to) has the potential to leach to ground water under certain conditions; however, it rapidly degrades under aerobic and anaerobic conditions reducing the likelihood of ground water contamination. Limited monitoring information for bromoxynil in ground water is available. The “Pesticides in Ground Water Database” (EPA 1992) reports sampling for bromoxynil in 107 wells in four counties in Oregon between 1985 and 1987. The well samples in each area (public water supply and domestic) were selected based on suspected vulnerability, susceptibility to contamination, and availability of information on well construction and depth. No additional information on the details of the monitoring was available. No detections of bromoxynil were reported.

Additional monitoring data from the United States Geological Survey (USGS) National Water Quality Program (NAQWA) represent the highest quality data and most recent data available (1993-1994). The program was carefully designed to obtain monitoring data for surface and ground waters from diffuse (non-point) sources. For ground water, one detection of bromoxynil (concentration not specified) was reported from a total of 2,245 samples. Clearly, these compounds (bromoxynil phenol and octanoate) are not considered candidates for restricted use due to ground water concerns and the potential for ground water contamination (and exposure) from bromoxynil is extremely low.

DBHA, a cotton metabolite, is not expected to be found in ground water.

ii. Surface water. Environmental fate studies indicate that bromoxynil (phenol and octanoate) should not persist in surface waters, although water monitoring data from the USGS NAWQA program show that bromoxynil has been detected in 1.1% of surface water samples. Modeled estimated environmental concentrations (EECs) were based on the cotton use and not the small grains, corn or other uses of bromoxynil because, it has been the Agency's experience, that using cotton as opposed to these crops results in a higher estimated surface water exposure. Cotton represents the most conservative use for surface water exposure (i.e., the highest possible exposure scenario).

A Tier II analysis based on the PRZM-EXAMS model (Pesticide Root Zone Model Version 2.3 plus Exposure Analysis Modeling System Version 2.94) was conducted for the cotton use. PRZM-EXAMS uses data on the physical-chemical properties of the pesticide plus soil and topographic characteristics, weather data, and water quality parameters for the modeled site. The model uses this information to estimate runoff from a 10 hectare agricultural field into an immediately adjacent 1 hectare by 2 meter deep pond. PRZM-EXAMS considers reduction in dissolved pesticide concentrations due to adsorption of pesticide to soil or sediment, incorporation, degradation in soil before wash off to a water body, direct deposition of spray drift into the water body, and degradation of the pesticide within the water body.

Water monitoring data from the USGS NAWQA Program were reported during the 1993-1995 period from 7 of 20 river basins throughout the U.S. The NAWQA Program examined drainage basins that were primarily agricultural use. The percentage of detections was 1.1% from a total of 1,925 surface water samples. Analysis of the 20 detections >0.03 parts per billion (ppb) yielded a median value of 0.105 ppb with a mean of 0.53 ppb. The maximum concentration was one data point at 6.1 ppb (12.2 ppb when accounting for 50% recovery) measured in the South Platte River Study Unit, CO. For urban land use, bromoxynil was not detected in surface waters. It is important to note the laboratory recoveries were approximately 50%. Apparently the laboratory recoveries did not vary considerably from the 50% level.

Based on model estimates (using PRZM-EXAMS), the maximum or peak estimated concentration for bromoxynil was 12.3 ppb and the maximum estimated long-term mean was 0.24 ppb (using 36 years of weather data). These values represent what might be expected in a small water body near a cotton field highly prone to runoff. The maximum peak estimated concentration for bromoxynil from the model correlates with the highest value detected in the USGS monitoring data, when this measured value has been corrected for an analytical recovery rate of 50%.

To estimate a reasonable high end exposure for the human health risk assessment, EPA focused on the calculated time-weighted annual mean concentrations of bromoxynil at each of 11 USGS monitoring sites, which the EPA views as located in watersheds likely to have bromoxynil use. (These values were not corrected for the analytical recovery rate of 50%.) These time-weighted annual mean concentrations ranged from 0.011 ppb to 0.18 ppb, with 10 out of the 11 sites with time-weighted annual mean concentrations below 0.05 ppb. Six of the 10 sites had time weighted annual mean concentrations at or below 0.014 ppb. The highest annual time-weighted mean (0.18 ppb) was located in a relatively small watershed (approximately 100 square miles) in a relatively small water body, and the calculated annual mean value at this site was significantly influenced by the presence of a single high value (the highest value found in all of the available monitoring data). Based on this information, EPA believes that 0.05 ppb is a reasonable high end estimate for purposes of estimating drinking water exposure.

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). Bromoxynil is not registered for use on any sites that would result in residential exposure.

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 bromoxynil 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, bromoxynil 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 bromoxynil 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).

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.

The bromoxynil data submitted to the Agency for review are sufficient for the assessment of hazard to the developing organism. A total of 11 developmental and 3 reproductive toxicity studies were available for review. These include oral prenatal developmental toxicity studies (three in rats, two in rabbits, and one in mice with the phenol; one in rats with the octanoate), dermal prenatal developmental toxicity studies (one each in rats and rabbits with both the phenol and the octanoate), and two dietary two-generation reproduction studies in rats (one with the phenol; one with the octanoate) and one dermal reproduction study. Developmental toxicity was observed, following in utero exposure to bromoxynil, in multiple studies, by two routes of exposure, and in three species. The induction of supernumerary ribs was shown to be the most sensitive indicator of developmental toxicity in fetal rats, mice, and (in certain studies) rabbits. Upon consideration of the data base in its entirety, the Agency determined that the developmental NOAEL, for the induction of supernumerary ribs, resulting from prenatal exposure to bromoxynil (phenol) is 4 mg/kg/day via the oral route and 10 mg/kg/day via the dermal route. The developmental LOAELs for bromoxynil phenol were 5 mg/kg/day by the oral route and 50 mg/kg/day by the dermal route. Other forms of developmental toxicity, including resorptions and malformations, were routinely observed in bromoxynil studies at higher dose levels.

It was determined that the FQPA safety factor should be retained for the subpopulation consisting of females 13+ for acute dietary exposures. This decision was based upon concerns emanating from the toxicological profile, including evidence of increased susceptibility of fetuses to bromoxynil exposure, the steep dose response curve, and the demonstrated severe developmental effects at doses above the LOAEL.

The population of concern is the developing fetus and the endpoint of concern is supernumerary ribs. This endpoint, a developmental anomaly, results from in utero exposure; therefore the population subgroup of concern is females 13+ years old. Although some systems in infants and children continue developing, it is unlikely that supernumerary ribs, even though observed across multiple species, would result from postnatal exposure. A 10-fold safety factor, as required by FQPA, will provide additional protection for infants and children and ensure a reasonable certainty of no harm to this sensitive subpopulation.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure and dietary exposure from drinking water, the acute aggregate exposure from food and water to bromoxynil will occupy <1% of the aPAD for the U.S. population, 11% of the aPAD for females 13 years and older, 2% of the aPAD for all infants and 2% of the aPAD for children 1-6 years old. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure and dietary exposure from drinking water, EPA has concluded that exposure to bromoxynil from food and water will utilize <1% of the cPAD for the U.S. population, <1% of the cPAD for all infants, and <1% of the cPAD for children 1-6 years old. There are no residential uses for bromoxynil that result in chronic residential exposure to bromoxynil. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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). Bromoxynil is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

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). Bromoxynil is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

5. Aggregate cancer risk for U.S. population. Using the exposure assumptions described in this unit for chronic/cancer exposure and dietary exposure from drinking water, EPA has concluded that exposure to bromoxynil from food and water resulted in an estimated aggregate cancer risk to the U.S. population of 1.7 x 10- 6. Bromoxynil is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate cancer risk is the sum of the risk from food and water only.

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 bromoxynil residues.

Adequate analytical methodology is available for data collection and tolerance enforcement for bromoxynil per se in plants. Method I in PAM, Vol. II, is a GLC/MCD that has undergone a successful EPA method validation on wheat grain. This method involves alkaline hydrolysis in methanolic KOH to convert residues to bromoxynil, cleanup by liquid-liquid partitioning, methylation using diazomethane, further cleanup on a Florisil column, and determination by GLC/MCD. Method Ia is the same method, but uses GC/ECD for determination of methylated bromoxynil.

Method A is a GC/MCD or ECD method for the analysis of bromoxynil residues in livestock tissues and is essentially the same as Method I. Method B is a GC/ECD method that is also similar to Method I, with modifications to the cleanup procedures.

There are no established or proposed Codex maximum residue levels for bromoxynil residues; no compatibility questions exist with respect to U.S. tolerances and Codex.

Therefore, the tolerance is established for residues of bromoxynil, 3,5-dibromo-4-hydroxybenzonitrile, in or on timothy, hay at 0.50 ppm and timothy, forage 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-301163 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 13, 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-301163, 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 other 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 exemption under FFDCA section 408, such as the tolerance 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.

Because this rule has been exempted from review under Executive Order 11866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).

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).

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 the Federal 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_180/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-301161. 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 residues of the fungicide fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile), in or on pomegranates at 5.0 parts 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.

Losses due to Botrytis have increased dramatically over the course of the last 2 years for pomegranate growers and packers. In the 1999 and 2000 packing seasons, growers and packers experienced approximately a 20% loss of fruit after packing for the fresh market due to Botrytis mold and had never experienced such frequency of decay before. Previously, they had been able to hold pomegranates for 2 to 3 months, but now have difficulties storing much beyond 2 to 3 weeks. EPA has authorized under FIFRA section 18 the use of fludioxonil on pomegranates for control of gray mold (Botrytis cinerea) in California. 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 fludioxonil in or on pomegranates. 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 pomegranates 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 fludioxonil meets EPA's registration requirements for use on pomegranates 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 fludioxonil 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 California 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 fludioxonil, contact the Agency's Registration Division at the address provided under FOR 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 fludioxonil and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for residues of fludioxonil in or on pomegranates at 5.0 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 intraspecies 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 x 10- 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 fludioxonil 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 180.516) for the residues of fludioxonil, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from fludioxonil 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 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 acute exposure assessments: For the acute DEEMTM analysis (version 7.72), published and proposed tolerances level residues were used. Default processing factors and 100% crop treated (CT) were assumed for all commodities.

ii. Chronic exposure. In conducting this chronic dietary risk assessment, the 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: For the chronic DEEMTM analysis (version 7.73), published and proposed tolerances level residues were used. Default processing factors and 100% CT were assumed for all commodities.

iii. Cancer. Fludioxonil has been put in “Group D”- not classifiable as to human carcinogenicity via relevant routes of exposure and therefore this 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 fludioxonil 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 fludioxonil.

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 SCI-GROW, which predicts pesticide concentrations in ground water. 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 fludioxonil they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models, the EECs of fludioxonil for acute exposures are estimated to be 46 parts per billion (ppb) for surface water and 0.35 ppb for ground water. The EECs for chronic exposures are estimated to be 11 ppb for surface water and 0.35 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).

Fludioxonil is not currently registered for residential (outdoor, non-food) uses, however, the registrant is seeking registration for the use of fludioxonil by commercial applicators on residential lawns. For adults, post-application exposures may result from dermal contact with treated turf. For toddlers, dermal and non-dietary oral post-application exposures may result from dermal contact with treated turf as well as hand-to-mouth transfer of residues from turfgrass.

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 fludioxonil 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, fludioxonil 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 fludioxonil 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. Safety factor for infants and children—i. 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.

ii. Developmental toxicity studies. In the rat developmental study, the maternal (systemic) NOAEL was 100 mg/kg/day, based on reduction in mean body weight gain in dams during gestation period at the LOAEL of 1,000 mg/kg/day. The developmental (fetal) NOAEL was 100 mg/kg/day, based on increased fetal and litter incidence of dilated renal pelvis and dilated ureter at the LOAEL of 1,000 mg/kg/day. In the rabbit developmental toxicity study, the maternal (systemic) NOAEL was 10 mg/kg/day, based on decreased body weight gains and food efficiency at the LOAEL of 100 mg/kg/day. The developmental (pup) NOAEL was 300 mg/kg/day, the highest dose tested.

iii. Reproductive toxicity study. In the 2-generation reproductive toxicity study in rats, the parental (systemic) NOAEL was 22.13 mg/kg/day (males) and 24.24 mg/kg/day (females), based on clinical signs and decreased body weight, body weight gain and food consumption at the LOAEL of 221.6 mg/kg/day (males) and 249.7 mg/kg/day (females). The reproductive/developmental (pup) NOAEL was 22.13 mg/kg/day (males) and 24.24 mg/kg/day (females), based on reduced pup weights at the LOAEL of 221.6 mg/kg/day (males) and 249.7 mg/kg/day (females).

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

v. Conclusion. EPA concludes that reliable data support the removal of the additional uncertainty factor; the standard hundred-fold uncertainty factor is adequate to protect the safety of 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 fludioxonil 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 fludioxonil on drinking water as a part of the aggregate risk assessment process.

1. Acute risk. Because the acute endpoint applies to one population subgroup, females (13-50 years old), the acute risk assessment was conducted only for this group. An acute dose and endpoint were not selected for the U.S. population (including infants and children) because there were no effects of concern observed in oral toxicology studies, including maternal toxicity in the developmental toxicity studies in rats and rabbits, that are attributable to a single exposure (dose).

Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to fludioxonil will occupy 0.7% of the aPAD for females (13-50 years old). In addition, despite the potential for acute dietary exposure to fludioxonil in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of fludioxonil in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fludioxonil from food will utilize 5.5% of the cPAD for the U.S. population, 22% of the cPAD for all infants <1 year old) and 14% of the cPAD for children 1 to 6 years old. Based on the use pattern, chronic residential exposure to residues of fludioxonil is not expected. In addition, despite the potential for chronic dietary exposure to fludioxonil in drinking water, after calculating DWLOCs and comparing them to conservative model of EECs fludioxonil in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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).

Fludioxonil is not currently registered for residential (outdoor, non-food) uses, however, the registrant is seeking registration for the use of fludioxonil by commercial applicators on residential lawns. For adults, post-application exposures may result from dermal contact with treated turf. For toddlers, dermal and non-dietary oral post-application exposures may result from dermal contact with treated turf as well as hand-to-mouth transfer of residues from turfgrass.

For the U.S. population and all infants (<1 year old) population subgroups, the total food and residential short-term aggregate MOEs are 1,900 and 995, respectively. As these values are greater than 100, the short-term food and residential aggregate risks for the U.S. population and all infants (<1 year old) population subgroups are below the Agency's level of concern. Because the all infants (<1 year old) population subgroup has the highest exposure to fludioxonil residues from dietary sources, including all infants (<1 year old) is adequately protective of the children 1-6 and 7-12 years old population subgroups.

In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of fludioxonil in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 4:

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).

Though residential exposure could occur with the use of fludioxonil, no residential exposure scenarios for fludioxonil are expected to have intermediate-term durations. Therefore, an intermediate-term aggregate risk assessment is not required.

5. Aggregate cancer risk for U.S. population. Fludioxonil has been put in “Group D”- not classifiable as to human carcinogenicity via relevant routes of exposure and therefore this 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 fludioxonil residues.

Adequate enforcement methodology (example - gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, 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 (MRLs) for fludioxonil on pomegranates.

Therefore, the tolerance is established for residues of fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile), in or on pomegranates at 5.0 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-301161 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 13, 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-301161, 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 exemption under FFDCA section 408, such as the [tolerance/exemption] 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.”

Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).

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).

Sections 1851 through 1859 of the Social Security Act (the Act) established Part C of the Medicare program, known as the “Medicare+Choice (M+C) Program.” On June 26, 1998, we published a comprehensive interim final rule (63 FR 34968) in the Federal Register to implement the M+C Program. That interim final rule set forth the M+C regulations in 42 CFR Part 422—Medicare+Choice Program. We published a subsequent final rule with comment period in the Federal Register on June 29, 2000 (65 FR 40170).

When these rules were promulgated, we established a 2-year recredentialing cycle consistent with standards adopted by nationally recognized private quality assurance accrediting organizations. Under § 422.204(b)(2)(ii), Medicare+Choice Organizations (M+COs) are required to recredential providers who are physicians or other health care professionals (including members of physicians groups) at least every 2 years. The recredentialing updates information obtained during initial credentialing, considers performance indicators such as those collected through quality assurance programs, utilization management systems, handling of grievances and appeals, enrollment satisfaction surveys, and other plan activities, and includes an attestation of the correctness and completeness of the new information.

Since the promulgation of these M+C rules, however, the nationally recognized private quality assurance accrediting organizations' standards for recredentialing have changed to a 3-year cycle. Therefore, our regulations are no longer consistent with standards adopted by these organizations. We believe that the change in the standards for recredentialing from a 2-year cycle to a 3-year cycle is appropriate because it lessens the administrative burdens on M+COs and their providers without negatively affecting Medicare beneficiaries or the Medicare program.

On December 27, 2000, we published a proposed rule in the Federal Register (65 FR 81813) proposing to change the requirement for the recredentialing of providers who are physicians or other health care professionals for M+COs in § 422.204(b)(2)(ii) from at least a 2-year cycle to at least a 3-year cycle. The proposed change to the regulation still allowed for M+COs to recredential their providers on a 2-year cycle if they wished to do so.

We received 8 timely comments in response to the December 27, 2000 proposed rule. The majority of the comments were from health plans and credentials verification organizations. We reviewed each commenter's letter and grouped like or related comments. Some comments were identical, indicating that the commenters had submitted form letters. The comments and our responses are summarized below.

Comment: The majority of commenters expressed their support of changing the recredentialing cycle for M+COs from at least every 2 years to at least every 3 years. They stated that the change will decrease administrative costs and result in consistency with private accrediting organizations, while at the same time maintaining the level of quality necessary to adequately protect Medicare beneficiaries.

Response: We appreciate the support of these commenters. This change will make our regulations consistent with the recredentialing standards adopted by nationally recognized private quality assurance accrediting organizations. We agree that it will lessen the administrative burdens on M+COs and their providers without negatively affecting Medicare beneficiaries or the Medicare program.

Comment: One commenter pointed out that the proposed rule modified § 422.204(b)(2)(ii) by omitting several words in the explanation of the purpose of recredentialing. The commenter agreed with the move from at least every 2 years to at least every 3 years, but suggested that the final rule otherwise retain the existing regulatory language.

Response: Our purpose for making minor editorial changes to the language was not to change the intent of the rule, but to make the language clearer. The recredentialing process does the following:

• Updates information obtained during initial credentialing.

• Considers performance indicators such as those collected through quality assurance programs, utilization management systems, handling of grievances and appeals, enrollee satisfaction surveys, and other plan activities.

• Includes an attestation of the correctness and completeness of the new information.

We understand the commenter's concern with the regulations text in the proposed rule and we have changed the text in this final rule to more accurately distinguish between the three components of recredentialing above.

Comment: Several commenters, representing credentials verification organizations (CVOs), expressed concern about moving from a 2-year to a 3-year recredentialing cycle. These commenters cited risk management issues, such as protecting their patients from harm, on the part of the M+COs.

These commenters also stated that timely and thorough recredentialing practices ensure quality health care, while reducing the risk to health plans and reducing the probability of medical errors and substandard care. They stated that there is no definitive research showing that moving to a 3-year cycle is in the best interest of the public (pointing out that of the 32 states that require recredentialing, 12 require recredentialing every 2 years while only eight require it every 3 years), and they believe that most M+COs will choose to implement the 3-year recredentialing cycle, even though we allow them to accept a more stringent standard.

Response: The M+CO must assess any possible risks, including risk management issues, of implementing any standards in their own organizations. Since the regulation still allows for more frequent recredentialing of providers, it is the decision of the M+CO whether to implement the 3-year recredentialing cycle. We believe that, as a national policy, risk management will not be negatively effected by a 3-year recredentialing cycle.

We agree that timely and thorough recredentialing is necessary to ensure quality health care, reduce risk to health plans and members, and reduce the probability of medical errors and substandard care. However, we agree with the nationally recognized private quality assurance accrediting organizations who have determined that these factors are not compromised by moving from a 2-year recredentialing cycle to a 3-year recredentialing cycle. If a State law requires a more stringent recredentialing cycle for M+CO providers, the State law supercedes our 3-year requirement.

Comment: Several commenters expressed the need for a form of interim monitoring of providers credentials including licensure, querying the National Practitioner Data Bank (NPDB), and sanction activity.

Response: We currently require interim monitoring in several ways. We require that all M+CO's monitor the Medicare and Medicaid sanction list published by the Office of the Inspector General as frequently as that list is published (monthly). We also require resolution and documentation of any member complaint or grievance. The M+CO is also prohibited from contracting with providers who opt out of Medicare. In addition to accessing the NPDB, M+COs are encouraged to query the Healthcare Integrity and Protection Data Bank (HIPDB). M+COs are also permitted to establish their own interim monitoring procedures, in order to ensure that unqualified providers are not providing care to Medicare beneficiaries.

Comment: One commenter suggested that we try to simplify and standardize credentialing requirements. The commenter suggested establishing a centralized credentialing provider databank and “perpetual” verifications, outside of the NPDB.

Response: Although this request is outside the scope of this regulation, we, in conjunction with other organizations, are in the process of exploring the possibility of having a centralized data bank for provider credentials.

Comment: One commenter suggested that we align our credentialing standards with those of the National Committee for Quality Assurance (NCQA). This commenter believes that a meaningful reduction in administrative burden is dependent upon comprehensive standardization. This commenter also believed that aligning standards with the NCQA standards would not compromise the rigorous standards currently required through the Quality Improvement System for Managed Care standards. Another commenter suggested that we accept a form of provisional credentialing to remain consistent with NCQA.

Response: Although this request is not directly related to this regulation, we are currently re-examining all of our standards related to provider credentialing. We are assessing standards that are implemented by private accrediting organizations and evaluating the applicability of those standards to the Medicare program.

This final rule incorporates the 3-year recredentialing cycle of the proposed rule. As discussed in section II of this preamble, we believe the requirement of a 3-year recredentialing cycle for providers who are physicians or other health care professionals for M+COs is consistent with industry standards and continues to ensure high quality care for Medicare beneficiaries.

We have made a minor editorial change to the language describing what recredentialing includes, but have not changed the substance or the intent of this language from the current regulation or the proposed rule.

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements:

Section 422.204 (Provider selection and credentialing) requires recredentialing at least every 3 years that updates information obtained during initial credentialing, considers performance indicators such as those collected through quality assurance programs, utilization management systems, handling of grievances and appeals, enrollee satisfaction surveys, and other plan activities, and includes an attestation of the correctness and completeness of the new information. While the criteria and timing of the recredentialing process is currently approved under OMB control number 0938-0753, the general recredentialing criteria of every 2 years is being revised to every 3 years.

If you comment on the information collection and recordkeeping requirements, please mail copies directly to the following:

We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review) and the Regulatory Flexibility Act (RFA) (September 19, 1980 Public Law 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 1 year). This rule is not a major rule, as there are no additional costs to implement the one change that results from this final rule. Since the rule changes the recredentialing requirement from a 2-year to a 3-year cycle, it decreases administrative costs for the health plan and the providers within the health plan.

The RFA requires agencies to analyze options for regulatory relief of small businesses. 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 or less annually (see 66 FR 69432). For purposes of the RFA, some M+COs 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 Social Security 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 50 beds.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million. This rule will not have an effect on State, local, or tribal governments, nor will the rule meet the $100 million threshold.

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 requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule does not impose any direct requirement costs on State or local governments.

The effect on M+COs will be to lessen the mandated recredentialing requirements to at least once every 3 years rather than the current requirement of at least once every 2 years. If the rule is not promulgated, Medicare M+COs would be required to recredential on a schedule that is different and more demanding for Medicare contractors than private contractors, adding an administrative complexity and cost without benefit. M+COs can maintain recredentialing more often at their option; this change simply addresses consistency with standards of private accreditation agencies.

Effects on other providers are limited, except that providers in M+COs will not be required to provide credentialing material at a greater frequency than they are required to provide it by the private accreditation agencies and the M+COs' individual corporate requirements.

This rule makes no change to the Medicaid program. The rule simplifies the recredentialing mandated cycle for consistency with the private accreditation processes for Medicare M+COs. If the rule is not promulgated, a cycle inconsistent with the private accreditation organizations will require private accreditation organizations to change their cycle in order to be deemed for Medicare and require M+COs and their providers to undergo an additional administrative cost and process without identified benefit to Medicare beneficiaries or the Medicare program.

The only other alternative would be to leave the regulation unchanged. To meet our goal to be consistent, when appropriate, with the standards of the private accreditation organizations, we decided that the change is necessary.

For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this rule does not have a significant economic impact on a substantial number of small entities, or a significant impact on the operations of a substantial number of small rural hospitals.

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 Report and Order, MM Docket No. 01-89 adopted August 22, 2001 and released August 31, 2001. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., (202) 857-3800, 1231 20th Street, NW., Washington, DC 20036.

At 66 FR 12902, March 1, 2001, and at 66 FR 16151, March 23, 2001, NMFS published final specifications for the 2001 scup and black sea bass; and summer flounder, fisheries, respectively, which included preliminary 2000 landings and 2001 quota adjustments. Further adjustments are made to the 2001 quotas through this notification, to account for audited 2000 summer flounder, scup, and black sea bass landings data from the states and for inadvertent errors in the preliminary 2000 quota adjustments.

The 2000 quota, reported 2000 landings, and the resulting 2000 overages and underages for all states for summer flounder are given in corrected summer flounder Table 2 in this document. The following states recorded 2000 landings of summer flounder that differ from those reported in the March 23, 2001, final rule, by the following amounts: MA, -1,506 lb (683 kg); RI, +9,310 lb (4,223 kg); CT, +5,520 lb (2,504 kg); NY, -37,048 lb (16,805 kg); NJ, -305,513 lb (138,578 kg); MD, -9,456 lb (4,289 kg); and VA, -19,477 lb (8,835 kg). While the State of NC reported additional landings, this action makes no quota adjustments because it is forbidden by a Court Order (North Carolina Fisheries Association v.Evans, July 30, 2001).

The resulting corrected and adjusted 2001 commercial quota for each state is given in corrected summer flounder Table 3 of this document.

The 2000 quotas (by period), reported 2000 landings (by period) and resulting overages for scup for all periods are given in corrected scup Table 2 of this document. Changes in 2000 landings from those reported in the March 1, 2001, final rule are as follows: Winter I, +17,661 lb (8,011 kg); Summer, +19,029 lb (8,631 kg); and Winter II, -357 lb (162 kg). This information resulted in total overages and resulting decreases to the 2001 Winter I and Summer quotas by 346,999 lb (157,396 kg) and 602,340 lb (273, 217 kg), respectively.

The resulting adjusted 2001 quota for each period is given in corrected scup Table 3 of this document.

The 2000 quotas (by quarter), reported 2000 landings (by quarter) and resulting overages for black sea bass for all quarters are given in corrected black sea bass Table 5 of this document. Changes in 2000 landings from those reported in the March 1, 2001, final rule are as follows: Quarter 1, -555 lb (252 kg); Quarter 2, +33,577 lb (15,230 kg); Quarter 3, -35,027 lb (15,888 kg); and Quarter 4, -58,292 lb (26,441 kg). This information resulted in total overages and resulting decreases to the 2001 Quarter 2, 3, and 4 quotas by 239,098 lb (108,453 kg), 61,049 lb (27,691 kg), and 22,760 lb (10,324 kg), respectively.

The resulting adjusted 2001 quota for each quarter is given in corrected black sea bass Table 6 of this document.

1. In the document published at 66 FR 16151, March 23, 2001, the following corrections are made:

On page 16153, Tables 2 and 3 are revised in their entirety as follows:

2. In the document published at 66 FR 12902, March 1, 2001, the following corrections are made:

On pages 12904, 12905, and 12906, Tables 2, 3, 5, and 6 are revised in their entirety as follows:

The domestic groundfish fisheries in the EEZ off Alaska are managed by NMFS under the FMPs. The FMPs were prepared by the North Pacific Fishery Management Council (Council) under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing the Alaska groundfish fisheries appear at 50 CFR parts 600 and 679.

This final rule clarifies the definition of vessel LOA by removing the definitions of stem and stern, revising the definition of LOA at 50 CFR 679.2 to include bulwarks explicitly, and adding a definition for bulwarks. Further information on this action may be found in the preamble to the proposed rule published at 66 FR 28883, May 25, 2001. The proposed rule invited public comment on this action through June 25, 2001. No comments were received on the proposed rule.

The final rule makes one change to the proposed rule. The proposed rule would have added to the regulations a definition of “bulwark” to read as follows: “Bulwark means a section of a vessel’s side, continued above the main deck as a protection against heavy weather.” This final rule revises that definition to delete the phrase “as a protection against heavy weather.” That phrase is merely descriptive, not essential to defining a bulwark, and, as such, is inappropriate for the regulatory definition.

The following conventions will be used when rounding the LOA to the nearest foot:

(1) When the amount exceeding a whole foot measurement is less than 6 inches (15.2 cm), the LOA would be equal to that whole foot measurement. For example, if the horizontal distance of a vessel is 124 ft, 5-3/4 inches (37.9 m), the LOA of the vessel would be 124 ft (37.8 m).

(2) When the amount exceeding a whole foot measurement is greater than 6 inches (15.2 cm), the LOA would be equal to the next whole foot measurement. For example, if the horizontal distance of a vessel is 124 ft, 6-1/8 inches (38.0 m), the LOA of the vessel would be 125 ft (38.1 m).

(3) When the amount exceeding a whole foot measurement is exactly 6 inches (15.2 cm), the LOA would be equal to that whole foot measurement if the number is even; however, if the number is odd, the LOA would be equal to the next whole foot measurement. For example, if the horizontal distance of a vessel is 124 ft, 6 inches (37.9 m), the LOA of the vessel would be 124 ft (37.8 m), but, if the horizontal distance of the vessel is 59 ft, 6 inches (18.1 m), the LOA of the vessel would be 60 ft (18.3 m).

This final rule has been determined to be not significant for purposes of Executive Order 12866.

NMFS prepared a supplemental FRFA that analyzes the potential impact of this action on small entities for purposes of the Regulatory Flexibility Act (RFA). NMFS considered the status quo or “no action” alternative of retaining the present definition of LOA without change. However, this was rejected in order to define LOA unambiguously and provide clear and certain regulatory guidance for measuring LOA of fishing vessels operating in the EEZ off Alaska. While this action is intended simply to clarify the existing definition of LOA and thus prevent any misunderstanding or equivocation by vessel owners in determining a vessel’s LOA, some vessels currently operating in the EEZ off Alaska under Federal Fisheries Permits may find their registered LOAs to be inconsistent with the regulatory definition of LOA. At present, approximately 1,613 vessels are registered to operate in the EEZ off Alaska under Federal Fisheries Permits. NMFS has taken steps to mitigate the impact of this action on small entities by not requiring vessel owners to determine whether their registered LOAs are consistent with the revised definition. Nevertheless, some of the 1,613 vessels currently operating in the EEZ off Alaska under Federal Fisheries Permits may find their registered LOAs to be inconsistent with the regulatory definition of LOA. Vessels failing to have correct LOA measurements may incur costs associated with remeasuring their LOA. Unfortunately, at this time, NMFS has insufficient data to assess the actual number of such vessels affected in this manner, but it believes most LOAs are accurate.

However, vessels that are near observer coverage thresholds (125 ft (38.1 m) or 60 ft (18.3 m), as applicable) may incur considerable cost if it is determined that their LOA is incorrect and if a higher level of observer coverage would be required. Approximately 38 vessels with recorded LOA measurements of 122 ft (37.2 m), 123 ft (37.5 m), and 124 ft (37.8 m), may be subject to more stringent observer requirements if their LOAs are actually 125 ft (38.1 m), or greater. Approximately 156 vessels with LOA measurements of 57 ft (17.4 m), 58 ft (17.7 m), and 59 ft (18.0 m) may be subject to more stringent observer requirements if their LOAs are actually 60 ft (18.3 m) or greater. Such vessels could incur costs of $300/day for an observer.

The FRFA provides some evidence that bulwarks are typically included in measurements of LOA by marine surveyors.

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.

Within any fishing year, under harvest or over harvest of a seasonal allowance of pollock may be added to or subtracted from the subsequent seasonal allowances of pollock in a manner to be determined by the Administrator, Alaska Region, NMFS (Regional Administrator), provided that a revised seasonal allowance does not exceed 30 percent of the annual TAC apportionment (§ 679.20(A)(5)(ii)(C)). The combined A, B, and C season allowance of the pollock TAC in Statistical Area 610 is 22,559 metric tons (mt) as established by the Final 2001 Harvest Specifications and Associated Management Measures for the Groundfish Fisheries Off Alaska (66 FR 7276, January 22, 2001 and 66 FR 37167, July 17, 2001). The Regional Administrator has determined that the A and B seasonal catch was in excess of the allowances by 170 mt and that the excess shall be proportionately subtracted from the subsequent seasonal allowances. The Regional Administrator hereby reduces the C season pollock TAC by 93 mt. In accordance with § 679.20(a)(5)(ii)(C), the C season allowance of pollock TAC in Statistical Area 610 is 10,905 mt.

In accordance with § 679.20(d)(1)(i), the Regional Administrator, has determined that the C season allowance of the pollock TAC in Statistical Area 610 will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 10,705 mt, and is setting aside the remaining 200 mt as bycatch to support other anticipated groundfish fisheries. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 610 of the GOA.

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 seasonal allocation of pollock in Statistical Area 610 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 to prevent exceeding the seasonal allocation of pollock in Statistical Area 610 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.

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 appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2001 B season apportionment of TAC for Atka mackerel in the Central Aleutian District is 15,540 metric tons (mt), of which no more than 7,148 mt may be harvested from Steller Sea lion protection areas (66 FR 7276, January 22, 2001 and 66 FR 37167, July 17, 2001). See §§ 679.20 (a)(8)(ii)(A) and 679.22 (a)(12)(iii)(B).

In accordance with § 679.22 (a)(12)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the allowable harvest of Atka mackerel in the Steller Sea lion protection areas in the Central Aleutian District has been reached. Consequently, NMFS is prohibiting trawling in selected rookery and haul out sites, as defined at Table 21 of 50 CFR 679.22 and described at 50 CFR 679.22 (a)(12)(iii)(A) in the Central Aleutian District of the BSAI.

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 amount of the 2001 Atka mackerel critical habitat limit in the Central Aleutian District 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 Atka mackerel critical habitat limit in the Central Aleutian District 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 679.22 and is exempt from review under Executive Order 12866.