In an interim rule effective and published in the Federal Register on November 22, 2000 (65 FR 70284-70286, Docket No. 99-092-1), we amended the bovine tuberculosis regulations in 9 CFR part 77 by recognizing two separate zones with different tuberculosis risk classifications in the State of Texas. That action was necessary to prevent the spread of tuberculosis and to further the progress of the domestic bovine tuberculosis eradication program.

Comments on the interim rule were required to be received on or before January 22, 2001. We received one comment by that date, from a veterinary medical association. The commenter supported the interim rule.

Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule without change.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived the review process required by Executive Order 12866.

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay certification of the airplane and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

Interested persons are invited to submit such written data, views, or arguments as they may desire. Communications should identify the rules docket number and be submitted in duplicate to the address specified above. The Administrator will consider all communications received on or before the closing date for comments. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Persons wishing the FAA to acknowledge receipt of their comments submitted in response to these special conditions must include with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. NM196.” The postcard will be date stamped and returned to the commenter.

On July 3, 2001, ElectroSonics, 4391 International Gateway, Columbus, Ohio, applied for a Supplemental Type Certificate (STC) to modify Dassault Aviation Mystere-Falcon 50 airplanes. The Dassault Aviation Mystere-Falcon 50 is a small transport category airplane. The Dassault Aviation Mystere-Falcon 50 airplanes are powered by three AlliedSignal Model TFE 731-3-1C Turbofan Engines with a maximum takeoff weight of 38,800 pounds. This aircraft operates with a 2-pilot crew and can hold up to 19 passengers. The modification incorporates the installation of a Rockwell Collins FDS-2000 Flight Display System. The FDS-2000 is a replacement for the existing Analog Flight Instrumentation, while also providing additional functional capability and redundancy in the system. The avionics/electronics and electrical systems installed in this airplane have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.101, ElectroSonics must show that the Dassault Aviation Mystere-Falcon 50 airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A46EU, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations included in the certification basis for the Dassault Aviation Mystere-Falcon 50 airplanes include 14 CFR part 25, dated February 1, 1965, as amended by amendment 25-1 through amendment 25-34; § 25.255, as amended by amendment 25-42; §§ 25.979(d) and (e), as amended by amendment 25-38; 25.1013(b)(1) as amended by amendment 25-36; § 25.1351(d), as amended by amendment 25-41; 25.1353(c)(6), as amended by amendment 25-42; Special Conditions No. 25-86-EU-24 dated March 6, 1979.

If the Administrator finds that the applicable airworthiness regulations (that is, part 25, as amended) do not contain adequate or appropriate safety standards for the Dassault Aviation Mystere-Falcon 50 airplanes modified by ElectroSonics because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, these Dassault Aviation Mystere-Falcon 50 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34, and the noise certification requirements of part 36.

Special conditions, as defined in § 11.19, are issued in accordance with 11.38 and become part of the airplane's type certification basis in accordance with § 21.101(b)(2).

Special conditions are initially applicable to the model for which they are issued. Should ElectroSonics apply at a later date for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under the provisions of § 21.101(a)(1).

As noted earlier, the Dassault Aviation Mystere-Falcon 50 airplanes modified by ElectroSonics will incorporate dual Electronic Primary Flight Display systems that will perform critical functions. These systems may be vulnerable to high-intensity radiated fields external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects of HIRF. Accordingly, this system is considered to be a novel or unusual design feature.

There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved that is equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Dassault Aviation Mystere-Falcon 50 airplanes modified by ElectroSonics. These special conditions require that new avionics/electronics and electrical systems that perform critical functions be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

With the trend toward increased power levels from ground-based transmitters, plus the advent of space and satellite communications coupled with electronic command and control of the airplane, the immunity of critical avionics/electronics and electrical systems to HIRF must be established.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1 or 2 below:

1. A minimum threat of 100 volts rms per meter electric field strength from 10 KHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the following field strengths for the frequency ranges indicated. Both peak and average field strength components from the Table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to Dassault Aviation Mystere-Falcon 50 airplanes modified by ElectroSonics. Should ElectroSonics apply at a later date for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well under the provisions of § 21.101(a)(1).

This action affects only certain design features on the Dassault Aviation Mystere-Falcon 50 airplanes modified by ElectroSonics. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the supplemental type certification basis for the Dassault Aviation Mystere-Falcon 50 airplanes modified by ElectroSonics.

1. Protection from Unwanted Effects of High-Intensity Radiated Fields (HIRF). Each electrical and electronic system that performs critical functions must be designed and installed to ensure that the operation and operational capability of these systems to perform critical functions are not adversely affected when the airplane is exposed to high-intensity radiated fields.

2. For the purpose of these special conditions, the following definition applies: Critical Functions: Functions whose failure would contribute to or cause a failure condition that would prevent the continued safe flight and landing of the airplane.

In light of the emergency closure of the U.S. equity and options markets from September 11, 2001 through September 14, 2001, law firms and registrants have asked the Commission how to calculate the average weekly reported volume of trading in an issuer's securities for purposes of Rule 144 1 under the Securities Act of 1933.2 Because the markets were open for only one day during the week beginning on September 10, 2001, the Commission believes that it is appropriate to use weeks preceding and subsequent to the week of September 10, 2001, but to not include that calendar week, in determining the average weekly reported volume of trading under Rule 144(e).

The Commission also believes that termination of a written Rule 10b5-1 3 plan between September 11, 2001 and September 28, 2001, inclusive, will not, by itself, call into question whether the plan was “entered into in good faith and not as part of a plan or scheme to evade” the insider trading rules.

Rule 144 defines specific circumstances in which a person will be deemed not to be engaged in a distribution and, therefore, not to be an underwriter as defined in Section 2(a)(11) of the Securities Act.4 The amount of securities that may be sold under this safe harbor is limited to a percentage of the shares outstanding or a percentage of the average weekly trading volume of an issuer's securities. Rule 144(e) prescribes that the average weekly trading volume for a class of securities will be calculated using the average weekly reported volume of trading in such securities on all national securities exchanges and/or reported through the automated quotation system of a registered securities association during the four calendar weeks preceding the dates outlined in Rule 144(e). The markets were open for only one day during the week beginning on September 10, 2001. Accordingly, that week will not provide a representative trading volume. Therefore, the Commission believes that the week of September 10, 2001 should be excluded from the calculation of the average weekly reported volume of trading in an issuer's securities under Rule 144(e) during a four calendar week period, and an additional prior week should be included, for a total of four calendar weeks.

In May 2001, the Commission staff issued interpretations regarding the termination of a written plan for trading securities that satisfies the affirmative defense conditions of Rule 10b5-1(c).5 The affirmative defense is available only for plans that are “entered into in good faith and not as part of a plan or a scheme to evade” the insider trading rules. Questions 15(b) and 15(c) of the staff's interpretations make clear that a written plan may be terminated through either the affirmative termination of the plan itself or the deemed termination of the plan through the cancellation of one or more plan transactions. Therefore, for example, if a plan previously had specified that sales be made during the week of September 17, 2001, a security holder would be terminating the plan if he or she cancelled that sale in order to continue to hold the securities. The interpretations also state that termination of a plan could affect the availability of the Rule 10b5-1(c) defense for prior plan transactions if the termination calls into question whether the plan was “entered into in good faith and not as part of a plan or scheme to evade” the insider trading rules within the meaning of Rule 10b5-1(c)(1)(ii). The absence of good faith or presence of a scheme to evade would eliminate the Rule 10b5-1(c) defense for prior transactions under the plan.

Due to the tragic events of September 11, 2001 and the subsequent closure of the U.S. equity and options markets, the Commission believes that termination of a written plan established prior to September 11, 2001 will not, by itself, call into question whether the plan was “entered into in good faith and not as part of a plan or scheme to evade” the insider trading rules within the meaning of Rule 10b5-1(c)(1)(ii) if the plan is terminated between September 11, 2001 and September 28, 2001, inclusive. Thus, the Commission believes that availability of the Rule 10b5-1(c) defense for transactions under the written plan would not be affected solely by termination of that plan between September 11, 2001 and September 28, 2001.

User fee airports are those which, while not qualifying for designation as an international or landing rights airport because of insufficient volume or value of business, have been approved by the Commissioner of Customs to receive the services of Customs officers on a fee basis for the processing of aircraft entering the United States and their passengers and cargo.

Pursuant to 19 U.S.C. 58b, an airport may be designated as a user fee airport if the Secretary of the Treasury determines that the volume of Customs business at the airport is insufficient to justify the availability of Customs services at the airport and the governor of the State in which the airport is located approves the designation. Generally, the type of airport that would seek designation as a user fee airport would be one at which a company, such as an air courier service, has a specialized interest in regularly landing.

Section 122.15(b), Customs Regulations (19 CFR 122.15(b)), sets forth a list of the user fee airports designated by the Commissioner of Customs in accordance with 19 U.S.C. 58b. Section 122.15(b) was most recently updated by a final rule published in the Federal Register (65 FR 31263) on May 17, 2000.

This document amends § 122.15(b) to reflect that the name of the user fee airport located in Ocala, Florida, has been changed from Ocala Regional Airport to Ocala International Airport.

Because this amendment merely reflects the changed name of a user fee airport that has already been designated by the Commissioner of Customs in accordance with 19 U.S.C. 58b and neither imposes additional burdens on, nor takes away any existing rights or privileges from, the public, pursuant to 5 U.S.C. 553(b)(B), notice and public procedure are unnecessary, and for the same reasons, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required.

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. This amendment does not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866.

The principal author of this document was Janet L. Johnson, Regulations Branch, Office of Regulations and Ruling, U.S. Customs Service. However, personnel from other offices participated in its development.

The Department of Labor (DOL or Department) published a final rule in this rulemaking in the Federal Register at 65 FR 43538 (July 13, 2000), with an effective date of November 13, 2000, implementing a delegation of authority from the INS to the Department to adjudicate petitions for the temporary employment of nonimmigrant aliens in agriculture in the United States. Concurrently, the INS published a Final Rule at 65 FR 43528 (July 13, 2000) with an effective date of November 13, 2000, transferring to the Secretary of Labor the authority to adjudicate petitions for temporary agricultural workers and the authority to decide appeals on these decisions and to make determinations for revocation of petition approvals.

Subsequently, the INS at 65 FR 67616 (November 13, 2000) published a final rule and DOL at 65 FR 67628 (November 13, 2000) published an interim final rule (IFR) deferring the effective dates of their final rules. The Department in its IFR invited comments on the deferral of the effective date. No comments were received by DOL on the deferral of the effective date.

The Department also reopened and extended the comment period at 65 FR 50170 (August 17, 2000) on a companion notice of proposed rulemaking (NPRM) published at 65 FR 43545 (July 13, 2000) setting forth implementation measures necessary to the successful implementation of the delegation of authority to adjudicate petitions. Among the implementation measures was a new Form ETA 9079, Application for Alien Employment Certification and H-2A Petition, which consolidated two current forms, ETA 750 Application for Alien Employment Certification) and INS I-129 (Petition for Nonimmigrant Workers). The NPRM also set forth the implementation of a new fee schedule to collect a combined fee for processing the petition and labor certification application. It is contemplated that under the administrative procedures arrived at by INS and the Employment and Training Administration to implement the delegation of the petition authority from INS to the Department, DOL will collect the petition fee on behalf of INS and will be reimbursed by INS for the costs involved in processing the H-2A petition.

The INS reopened and extended the comment period at 65 FR 50166 (August 17, 2000) on a proposed rule published concurrently at 65 FR 43535 (July 13, 2000) with its final rule delegating the authority to adjudicate petitions to DOL. The INS proposed rule provided, among other things, that all petition requests and extensions of stay and change of status petitions must be filed with DOL and the current INS petition fee will be collected by DOL as part of a combined fee.

Commenters raised a number of issues about the proposed rules. The comments received by the Department as a result of the August 17, 2000, reopening and extension of the proposed rule did not provide sufficient information to permit the Department to draft a final rule concerning a number of issues, such as the design of the new form and the fee structure. Consequently, the Department intends in the near future to again reopen and extend the comment period on the July 13, 2000, NPRM. In a document published elsewhere in this issue of the Federal Register, the Department is reopening and extending the comment period on the NPRM. In another document, the Department is announcing informal briefings to allow agricultural workers and employers and other interested parties to communicate directly with the Department regarding the proposed rule changes which would require employers to submit fees for temporary labor certification and the associated H-2A petition with a consolidated application form at the time of filing, and as indicated above, sets forth a new fee structure for the labor certification.

Finalizing the proposed rules is essential to the effective implementation of any delegation of authority to DOL to adjudicate petitions for temporary employment of nonimmigrant aliens in the United States. Allowing the Final Rule to become effective without finalizing action on the proposed rule published by the Department would lead to administrative uncertainty and result in confusion on the part of employers, agricultural workers, and other interested parties. Accordingly, the Department has concluded good causes exists to defer the effective date of the July 13, 2000, Final Rule until the rulemaking on the companion proposal is completed. At this time we are extending the effective date of the final rule published at 65 FR 43538 for one year, until October 27, 2002. The regulatory certifications set forth in the July 13, 2000, Final Rule apply to this deferral as well.

In the Federal Register of September 9, l976 (41 FR 38312), FDA published, under § 330.10(a)(6) (21 CFR 330.10(a)(6)), an advance notice of proposed rulemaking to establish a monograph for OTC cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) drug products, together with the recommendations of the Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (the Panel), which was the advisory review panel responsible for evaluating data on the active ingredients in this drug class. The Panel placed the combination of an oral bronchodilator with either an analgesic-antipyretic, anticholinergic, antihistamine, or antitussive (when the product is labeled only for cough associated with asthma) ingredient in Category II (not generally recognized as safe and/or effective) (41 FR 38312 at 38326).

The agency concurred with the Panel in the tentative final monograph for cough-cold combination drug products (53 FR 30522 at 30556, August 12, 1988). The agency also classified the combination of caffeine and ephedrine or pseudoephedrine in Category II (53 FR 30522 at 30557). No comments on these specific combinations were submitted in response to the tentative final monograph.

The current monograph oral bronchodilator active ingredients are ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine hydrochloride (21 CFR 341.16(a), (b), (c), and (f)). The agency is not aware of any OTC drug products currently marketed containing an oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient.

The OTC drug review program establishes conditions under which OTC drugs are generally recognized as safe and effective and not misbranded. Two principal conditions examined during the review are allowable ingredients and allowable labeling. The Panel evaluated the submitted data on active ingredients in combination products from the standpoint of safety and effectiveness and, based on its evaluation, recommended specific combinations of ingredients from the same and different pharmacologic groups. The Panel classified a number of cough-cold combinations as Category II (41 FR 38312 at 38326) and considered medical rationale and drug interaction in making these recommendations.

In the tentative final monograph for OTC cough-cold combination drug products (53 FR 30522 at 30556 to 30557), the agency agreed with the Panel’s recommended Category II status of any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient. The agency invited interested persons to submit written comments and new data demonstrating the safety and effectiveness of those conditions not classified in Category I (53 FR 30522 at 30560). The agency did not receive any comments in response to its request for such information concerning the proposed Category II status of any of the above-mentioned OTC cough-cold combination drug products containing an oral bronchodilator.

Accordingly, in this final rule the agency is finalizing the nonmonograph status of any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient. Thus, any drug product labeled, represented, or promoted for use as an OTC cough-cold combination drug that contains any oral bronchodilator active ingredients in combination with any of these specific active ingredients may be considered a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)) and misbranded under section 502 of the act (21 U.S.C. 352). These specific combination drug products can not be marketed for OTC cough-cold use unless they are the subject of an approved application under section 505 of the act (21 U.S.C. 355) and part 314 of the regulations (21 CFR part 314). Any OTC cough-cold combination drug product included in new § 310.545(a)(6)(iv)(D) that is initially introduced or initially delivered for introduction into interstate commerce after the effective date stated in § 310.545(d)(33) of this final rule that is not in compliance with the regulations is subject to regulatory action.

The agency did not receive any comments in response to its request in the tentative final monograph (53 FR 30522 at 30560) for specific comment on the economic impact of this rulemaking. FDA has examined the impacts of this final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement and economic analysis before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation).

The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The purpose of this final rule is to declare any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient as not generally recognized as safe and effective. The agency does not believe that any of these combination drug products are currently marketed OTC. Therefore, this final rule should have no economic impact on any manufacturer.

Under the Unfunded Mandates Reform Act, FDA is not required to prepare a statement of costs and benefits for this final rule because this final rule is not expected to result in an expenditure that would exceed $100 million adjusted for inflation in any one year.

The agency certifies that the final rule will not have a significant impact on a substantial number of small entities.

The agency has determined under 21 CFR 25.31(a) that this action is of a type that is categorically excluded from the preparation of an environmental assessment because these actions, as a class, will not result in the production or distribution of any substance and therefore will not result in the production of any substance into the environment.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements.

1. The authority citation for 21 CFR part 310 continues to read as follows:

2. Section 310.545 is amended by adding paragraph (a)(6)(iv)(D), by revising paragraph (d) introductory text, by adding and reserving paragraph (d)(32), and by adding paragraph (d)(33) to read as follows:

(a) * * * 

(6) * * * 

(iv) * * * 

(D) Approved as of October 29, 2001. Any oral bronchodilator active ingredient (e.g., ephedrine, ephedrine hydrochloride, ephedrine sulfate, racephedrine hydrochloride, or any other ephedrine salt) in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient.

Changes to the applicable law were made by the Miscellaneous Trade and Technical Corrections Act of 1999, Public Law 106-36 (113 Stat. 127). On January 4, 2001, temporary regulations (TD 8924) were published in the Federal Register (66 FR 723) under section 301 of the Internal Revenue Code, relating to liabilities assumed in connection with a distribution of property made by a corporation with respect to its stock. A notice of proposed rulemaking cross-referencing the temporary regulations was published in the Federal Register for the same day (66 FR 748). No public hearing was requested or held.

No written comments responding to the notice were received. This document adopts, without substantive change, final regulations with respect to the notice of proposed rulemaking.

The regulations apply generally to distributions occurring after January 4, 2001. The regulations also apply to distributions occurring on or prior to January 4, 2001, if the distribution is made as part of a transaction described in, or substantially similar to, the transaction in Notice 99-59 (1999-2 C.B. 761), including transactions designed to reduce gain. Under section 7805(b)(3), the Secretary may provide that any regulation may take effect or apply retroactively to prevent abuse. These regulations are being applied retroactively to prevent the abuse described in Notice 99-59. No inference should be drawn regarding the tax treatment of distributions not covered by these regulations.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required.

It is hereby certified that these final regulations do not have a significant economic impact on a substantial number of small entities. These final regulations under section 301 address distributions by corporations in which liabilities are assumed by the shareholders or in which the distributed property is subject to liabilities. These final regulations provide that the amount of a distribution under section 301 will be reduced by the amount of any liability that is treated as assumed by the distributee within the meaning of section 357(d).

These regulations apply to persons receiving distributions of property in which the property is subject to a liability, or in which liabilities are assumed by the distributee. These regulations, however, will affect only those persons described in the preceding sentence that would have, but for the regulations, considered liabilities to have been assumed in circumstances other that those described in section 357(d). Therefore, most businesses will not be affected by the final regulations in any given year. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking accompanying these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small businesses.

The principal author of these regulations is Michael N. Kaibni of the Office of the Associate Chief Counsel (Corporate). However, other personnel from the IRS and Treasury Department participated in their development.

Under 27 CFR 4.23 (b), a wine bottler may use a grape variety name as the designation of a wine if not less than 75 percent of the wine (51 percent in circumstances detailed in § 4.23(c)) is derived from that grape variety. Under § 4.23(d), a bottler may use two or more grape variety names as the designation of a wine if:

• All grapes used to make the wine are the labeled varieties;

• The percentage of the wine derived from each grape variety is shown on the label; and

• If labeled with multiple appellations, the percentage of the wine derived from each varietal from each appellation is shown on the label.

Treasury Decision ATF-370 (61 FR 522), January 8, 1996, adopted a list of grape variety names that ATF has determined to be appropriate for use in designating American wines. The list of prime grape names and their synonyms appears at § 4.91, while additional alternative grape names temporarily authorized for use are listed at § 4.92.

ATF has received petitions proposing that new grape variety names be listed in § 4.91. Under § 4.93 any interested person may petition ATF to include additional grape varieties in the list of prime grape names. Information with a petition should provide evidence of the following:

• Acceptance of the new grape variety;

• The validity of the name for identifying the grape variety;

• That the variety is used or will be used in winemaking; and

• That the variety is grown and used in the United States.

For the approval of names of new grape varieties, the petition may include:

• A reference to the publication of the name of the variety in a scientific or professional journal of horticulture or a published report by a professional, scientific or winegrowers' organization;

• A reference to a plant patent, if patented; and

• Information about the commercial potential of the variety, such as the acreage planted and its location or market studies.

Section 4.93 also places certain eligibility restrictions on the approval of grape variety names. A grape variety name will not be approved:

• If the name has previously been used for a different grape variety;

• If the name contains a term or name found to be misleading under § 4.39; or

• If the name of a new grape variety contains the term “Riesling.”

The Director reserves the authority to disapprove the name of a new grape variety developed in the United States if the name contains words of geographical significance, place names, or foreign words which are misleading under § 4.39. The Director will not approve the use of a grape variety name that is misleading.

Tablas Creek Vineyard in Paso Robles, California, petitioned ATF proposing the addition of the name “Counoise” to the list of prime grape variety names approved for the designation of American wines. Counoise is a red varietal originally from the Rhone region of France, where it has traditionally been a component of Chateauneuf-du-Pape.

The petitioner submitted the following published references to Counoise to establish its acceptance as a grape and the validity of its name:

• Cepages et Vignobles de France, Volume II, by Pierre Galet, 1990, pp. 106-107.

• Catalogue of Selected Wine Grape Varieties and Clones Cultivated in France, published by the French Ministry of Agriculture, Fisheries and Food, 1997, pp. 67 & 216.

• Traite General de Viticulture Ampelographie, Volume II, by P. Viala and V. Vermoral, 1991, pp. 78-80.

• Guide to Wine Grapes, Oxford University Press, 1996, by Jancis Robinson, p. 61.

The first three references are scientific articles that discuss the grape's origin, cultivation, and ampelography (the study and classification of grapevines). The Guide to Wine Grapes, intended for the general reader, discusses the cultivation of Counoise in the Rhone region and notes that it is “one of the more rarefied ingredients in red Chateauneuf-du-Pape.”

Tablas Creek Vineyard stated that it imported the Counoise plant into the USDA station in Geneva, New York, in 1990. The plant was declared virus free in 1993 and shipped bare-root to Tablas Creek Vineyard in Paso Robles, California in February 1993. The winery multiplied, grafted and started planting Counoise in 1996.

The petitioner stated that the Counoise grape is currently grown and used in the United States in winemaking. It reported that in 1999 and 2000, it shipped several orders for Counoise grafted vines, own-root plants and budwood to vineyards in California, Washington, and Arizona. When ATF contacted some of these vineyards, they reported that the plants are doing well and that they plan to produce wine from the resulting grapes.

In addition, the petitioner stated that Counoise has enormous commercial potential in California. The variety is easy to graft and moderately vigorous. It is well adapted to most California regions, ripening fairly late in the cycle, after Grenäche but before Mourvèdre and Cabernet Sauvignon. Tablas Creek has had three crops off their 3.5 acre planting. The winery reported that the 1998 harvest had a brix of 23.6 with a pH of 3.4, while the 1999 harvest had a brix of 26.9 with a pH of 3.4. The petitioner further stated that the wine is well-colored and rich, with excellent aromatics and spice.

Mr. Robin Partch of Northern Vineyards Winery in Stillwater, Minnesota, petitioned ATF for the addition of the name “St. Laurent” to the list of prime grape variety names approved for the designation of American wines. St. Laurent is a red Vitis vinifera grape originally from France, but now grown mainly in central Europe, especially Austria.

The petitioner submitted several published references to St. Laurent as evidence of its acceptance and name validity, including the following:

• The Oxford Companion to Wine, 1st edition, edited by Jancis Robinson, 1994, pp. 839-840.

• Production of Grapes and Wine in Cool Climates, by David Jackson and Danny Schuster, 1994, pp. 105-106.

• Vines, Grapes and Wines, by Jancis Robinson, 1986, p. 221. According to these references, St. Laurent is a deeply colored grape with a thick skin, which makes it disease resistant. It buds early and is thus susceptible to spring frosts, but it also ripens early.

The petitioner offered the following evidence that the St. Laurent grape is grown and used in the U.S. for winemaking. According to the petitioner, one commercial grower in Minnesota, a member of the Minnesota Winegrowers Cooperative, planted about 1/4 an acre of St. Laurent in 1995. The petitioner has made wine from the 1999 crop and is pleased with the results. The grower reported that the grape's disease-resistance and tendency to ripen early make it suitable for cooler climates with a short growing season.

The petitioner reported that St. Laurent plants are also being grown in the collection of the University of Minnesota. This was confirmed by Peter Hemstad, a research viticulturist at the University's Horticulture Research Center, who reported that he has made a good quality red wine from the University's grapes. Mr. Hemstad stated that he expects St. Laurent to become more widely planted in the U.S., especially in cooler climates. He further stated that he would recommend St. Laurent to growers in cooler climate states such as Minnesota, Michigan, and New York.

Based on the evidence submitted by the petitioners, ATF published Notice 915 on April 17, 2001, proposing to add the names “Counoise” and “St. Laurent” to the list of approved names in § 4.91. ATF received two comments in response to the notice. One was from the vineyard manager of the Viticulture and Enology Department at the University of California at Davis, who noted that Counoise has been in the university's collections since 1975. The other comment, from a London wine merchant, discussed the marketability of Counoise and St. Laurent wines in the export market.

After reviewing the evidence and comments, ATF has decided that sufficient evidence has been provided to satisfy the requirements under § 4.93. ATF is therefore amending § 4.91 to include the names “Counoise” and “St. Laurent.”

The provisions of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this final rule because no requirement to collect information is imposed.

It is hereby certified that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation will permit the use of the grape varietal names “Counoise” and “St. Laurent.” No negative impact on small entities is expected. No new requirements are proposed. Accordingly, a regulatory flexibility analysis is not required.

This is not a significant regulatory action as defined by Executive Order 12866. Therefore, a regulatory assessment is not required.

The principal author of this document is Jennifer Berry, Regulations Division, Bureau of Alcohol, Tobacco and Firearms.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. On September 11, 2001, two commercial aircraft were hijacked from Logan Airport in Boston, Massachusetts and flown into the World Trade Center in New York, New York inflicting catastrophic human casualties and property damage. A similar attack was conducted on the Pentagon on the same day. National security and intelligence officials warn that future terrorist attacks against civilian targets may be anticipated. This rulemaking is urgently required to prevent future terrorist strikes within and adjacent to waters within the Boston Marine Inspection Zone and Captain of the Port Zone. The delay inherent in the NPRM process is contrary to the public interest insofar as it may render individuals, vessels and facilities within and adjacent to the Boston Marine Inspection Zone and Captain of the Port Zone vulnerable to subversive activity, sabotage or terrorist attack.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. The measures contemplated by the rule are intended to prevent future terrorist attack against individuals, vessels and waterfront facilities within or adjacent to the Boston Marine Inspection Zone and Captain of the Port Zone. Immediate action is required to accomplish these objectives. Any delay in the effective date of this rule is impracticable and contrary to the public interest.

On September 11, 2001, terrorists launched attacks on civilian and military targets within the United States killing large numbers of people and damaging properties of national significance. Vessels operating within the Boston Marine Inspection Zone and Captain of the Port Zone present possible targets of terrorist attack or platforms from which terrorist attacks may be launched upon other vessels, waterfront facilities and adjacent population centers. The Coast Guard has established a temporary anchorage ground on Massachusetts Bay and Regulated Navigation Areas within the waters of Boston Harbor, Salem Harbor and Weymouth Fore River Channel, as part of a comprehensive, port security regime designed to safeguard human life, vessels and waterfront facilities from sabotage or terrorist acts. The Captain of the Port will determine the threat posed by and to affected vessels before they are allowed to enter the Regulated Navigation Areas and may establish conditions under which they are allowed to enter, transit or operate within those areas. Prior to the determination of whether and under what conditions a vessel may enter, transit or operate within the Regulated Navigation Areas, vessels may be directed by the Captain of the Port to temporarily anchor in the temporary anchorage area established in Massachusetts Bay. In addition, the Coast Guard has established five (5) safety and security zones having identical boundaries, which restrict entry into or movement within portions of Boston Inner Harbor, Salem Harbor and Plymouth Bay.

The rule establishes three Regulated Navigation Areas (RNAs) comprised of the waters within Boston Inner Harbor, Salem Inner Harbor and the Weymouth Fore River Channel, respectively. Towing vessels, tankers, tug and barge combinations, research vessels, container, dry bulk ships and passenger ships over 300 gross tons are required to obtain authorization from the Captain of the Port before entering any of these RNAs. The rule does not apply to commuter ferries, recreational boats or commercial fishing vessels.

In order to obtain authorization, a vessel subject to this rule is required to submit a “Notice of Arrival” information sheet and its crew list to Coast Guard Marine Safety Office Boston at least 24 hours in advance of its intended entry into an RNA. In addition, it will be required to undergo an inspection to the satisfaction of the Captain of the Port. Vessels awaiting Captain of the Port inspection or authorization will be directed to anchor in the Massachusetts Bay Anchorage Grounds established by this rule. Vessels to which this rule is applicable must also receive approval prior to leaving the port. Vessels will be required to notify the Captain of the Port of any changes in crew while in Port prior to receiving authorization to depart any of the Regulated Navigation Areas.

The Captain of the Port may authorize a vessel subject to this rule to enter an RNA under such circumstances and conditions as he deems appropriate to minimize the threat of injury to the vessel, the port, waterfront facilities or adjacent population centers resulting from sabotage or terrorist acts launched against or from the vessel.

Violations of the RNA regulations are punishable by civil penalties (not to exceed $25,000 per violation), criminal penalties (imprisonment for not more than 6 years and a fine of not more than $250,000) and in rem liability against the offending vessel.

The rule also establishes five distinct safety and security zones having identical boundaries. Four of these zones are being established by reference to a radius around a particular coordinate or easily identifiable landmark. One zone is being established by reference to readily identifiable boundaries. All of the zones are being established in order to protect the waterfront facilities, terminals, power plants, as well as persons and vessels from subversive or terrorist acts.

No person or vessel may enter or remain in the prescribed safety and security zones at any time without the permission of the Captain of the Port. Each person or vessel in a safety and security zone shall obey any direction or order of the Captain of the Port. The Captain of the Port may take possession and control of any vessel in a safety and security zone and/or remove any person, vessel, article or thing from a security zone. No person may board, take or place any article or thing on board any vessel or waterfront facility in a security zone without permission of the Captain of the Port.

Any violation of any safety or security zone described herein, is punishable by, among others, civil penalties (not to exceed $25,000 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment for not more than 10 years and a fine of not more than $100,000), in rem liability against the offending vessel, and license sanctions.

While this rule may be later determined to be a significant regulatory action under section 3(f) of Executive Order 12866, requiring further analysis of potential costs and benefits under section 6(a)(3) of that order, immediate implementation of this rule is necessary to ensure the safety and security of the Port and, as such, must be made without the requisite, prior administrative finding. The Office of Management and Budget has not reviewed it under that order. It may, or may not, be significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). However, the sizes of the zones are the minimum necessary to provide adequate protection for the public, vessels, and vessel crews. Any vessels seeking entry into or movement within the safety and security zones must request permission from the Captain of the Port or his authorized patrol representative. Any hardships experienced by persons or vessels are considered minimal compared to the national interest in protecting the public, vessels, and vessel crews from the further devastating consequences of the aforementioned acts of terrorism, and from potential future sabotage or other subversive acts, accidents, or other causes of a similar nature.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the Coast Guard has not yet determined whether this proposal will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses and 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 is not presently able to certify under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601, et seq.) that this final rule will not have a significant economic impact on a substantial number of small entities. However, given the continued risk and potential damage to the national security interests of the United States, in addition to the need to protect and safeguard innocent civilians within and near the port, it is necessary to implement this regulation before said analysis may be fully accomplished. Maritime advisories will be initiated by normal methods and means and will be widely available to users of the area.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding this final rule so that they can better evaluate its effects on them and participate in the rulemaking. If your small business or organization would be affected by this final rule and you have questions concerning its provisions or options for compliance, please call Lieutenant (junior grade) Dave Sherry, Marine Safety Office Boston, at (617) 223-3000. 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 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will 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.

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 create 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 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.

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 have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph 34(g) of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM, and, under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register. The Coast Guard had insufficient advance notice to publish an NPRM followed by a temporary final rule that would be effective before the necessary date. Publication of a notice of proposed rulemaking and delay of effective date would be contrary to the public interest because immediate action is necessary to prevent possible loss of life, injury, or damage to property.

This temporary security zone is necessary to ensure the security of the Ginna nuclear power plant, as a result of the terrorist attacks on the United States on September 11, 2001. This security zone consists of all navigable waters of Lake Ontario within a line from 43°16.9′ N, 77°18.9′ W; north to 43°17.5′ N, 77°18.9′ W; east to 43°17.5′ N, 77°18.3′ W; south to 43°16.7′ N, 77°18.3′ W; back to the starting point 43°16.9′ N, 77°18.9′ W. (NAD 83). Entry into, transit through or anchoring within this security zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The designated on-scene representative will be the Patrol Commander and may be contacted via VHF/FM Marine Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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).

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have 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.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. 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 Marine Safety Office Buffalo (see 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 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will 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.

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 create 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 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.

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.

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM, and, under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register. The Coast Guard had insufficient advance notice to publish an NPRM followed by a temporary final rule that would be effective before the necessary date. Publication of a notice of proposed rulemaking and delay of effective date would be contrary to the public interest because immediate action is necessary to prevent possible loss of life, injury, or damage to property.

A temporary security zone is necessary to ensure the security of the Nine Mile Point and James A. Fitzpatrick nuclear power plants as a result of the terrorist attacks on the United States on September 11, 2001. The security zone consists of all navigable waters of Lake Ontario within a line from 43°30.8′ N, 76°25.7′ W; north to 43°31.2′ N, 76°25.7′ W; east-northeast to 43°31.6′ N, 76°24.9′ W; east to 43°31.8′ N, 76°23.2′ W; south to 43°31.5′ N, 76°23.2′ W. (NAD 83). Entry into, transit through or anchoring within this security zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The designated on-scene representative will be the Patrol Commander and may be contacted via VHF/FM Marine Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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).

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have 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.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. 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 Marine Safety Office Buffalo (see 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 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will 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.

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 create 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 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.

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.

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. Publishing a NPRM and delaying its effective date would be contrary to the public interest since immediate action is needed to protect the public, ports and waterways of the United States. The Coast Guard will issue a broadcast notice to mariners and place Coast Guard vessels in the vicinity of these zones to advise mariners of the restriction.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

Based on the September 11, 2001, terrorist attacks on the World Trade Center buildings in New York and the Pentagon in Arlington, Virginia, there is an increased risk that subversive activity could be launched by vessels or persons in close proximity to the Port of Charleston, South Carolina, against tank vessels, cruise ships and military pre-positioned vessels entering, departing and moored within this port. There is a risk that subversive activity could be launched by vessels or persons in close proximity to the Port of Charleston, South Carolina against tank vessels, cruise ships and military pre-positioned vessels entering, departing and moored within these ports. Military pre-positioned ships are U.S. commercial ships on long-term charter to the Military Sealift Command. They are utilized to transport military equipment and cargo. There will be Coast Guard and local police department patrol vessels on scene to monitor traffic through these areas. Entry into these security zones is prohibited, unless specifically authorized by the Captain of the Port, Charleston, South Carolina.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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).

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard considered whether this rule would have a significant economic effect upon a substantial number of small entities. “Small entities” include 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 because small entities may be allowed to enter on a case by case basis with the authorization of the Captain of the Port.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

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 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 requirements under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

A rule has implication for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will 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 considered the environmental impact of this rule and concluded under Figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation.

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 direct effect on one or more Indian tribes, on the relationships between the Federal Government 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 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 did not publish a notice of proposed rulemaking (NPRM) for this regulation. The Coast Guard for good cause finds that, under 5 U.S.C. 553(b)(B) and (d)(3), notice and public comment on the rule before the effective date of the rule and advance publication are impracticable and contrary to public interest. Immediate action is necessary to ensure the safety of life, property, the environment, as well as safe passage for vessels transiting this area. The conduct of notice and comment rulemaking proceedings and compliance with advance notice requirements present significant public safety concerns that outweigh the public interest in compliance with these provisions. Public rulemaking proceedings and advance publication could provoke consequences that would pose a risk of harm to the public, military personnel, and law enforcement personnel charged with enforcement of the security zone. This regulation is geographically limited and in effect for such limited duration that it meets the needs of national security with a minimal burden on the public.

This security zone is required to ensure the security of the Moses-Saunders Power Dam as a result of the terrorist attacks on the United States on September 11, 2001. Pursuant to this regulation, no vessel or person will be allowed to enter, transit through, or anchor in the security zone unless specifically authorized by the District Commander, the Captain of the Port Buffalo (COTP), or one of the Captain of the Port's designated representatives. The Captain of the Port or one of his designated representatives can be reached on Marine Channel 16.

This security zone is established pursuant to the authority of Subpart D of part 165 of Title 33 of the Code of Federal Regulations and the Magnuson Act regulations promulgated by the President under 50 U.S.C. 191, including subparts 6.01 and 6.04 or part 6 Title 33 of the Code of Federal Regulations. See Executive Order 10173, as amended. The security zone is needed to protect the Moses-Saunders Power Dam on the St. Lawrence River. This zone in Massena, New York, encompasses United States navigable waters of the St. Lawrence River from the point 45°00.3′ N, 74°48.2′ W; east to the international border at 45°00.5′ N, 74°47.9′ W; then southeast along the international border to 45°00.3′ N, 74°47.6′ W; along the international border to 45°00.3′ N, 74°47.4′ W; southwest to 44°00.0′ N, 74°47.8′ W; northwest to 45°00.2′ N, 74°48.0′ W; back to starting point 45°00.3′ N, 74°48.2′ W. (NAD 83).

Vessels or persons violating this section are subject to the penalties set forth in 50 U.S.C. 192: seizure and forfeiture of the vessel, a monetary penalty of not more than $250,000, and imprisonment for not more than 10 years.

This temporary 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. It has not been reviewed by the Office of Management and Budget 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 security zone covers a vital portion of the St. Lawrence River transited by commercial vessels and is being created to protect the Moses-Saunders Power Dam. In addition, the security zone is necessary to ensure the safety of land and adjacent waterfront facilities. The Coast Guard does not foresee any interruption to the passage of vessels through this area. While the vessels will need authorization to transit the zone, the Coast Guard expects this not to interfere with or delay their passage.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) the Coast Guard considered whether this rule will have a significant impact on a substantial number of small businesses and not-for-profit organizations that are not dominant in their respective fields, and government jurisdictions with populations less than 50,000.

The Coast Guard certifies under section 605 (b) that this temporary final 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 the St. Lawrence River in the vicinity of the Moses-Saunders Power Dam.

This security zone will not have a significant economic impact on a substantial number of small entities for the following reasons. Vessel traffic will be allowed to pass through the zone with the permission of the COTP or his designated on scene representative.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding this rule so that they can better evaluate its effectiveness and participate in the rulemaking process. If your small business or organization is affected by this rule, and you have questions concerning its provisions or options for compliance, please contact the office listed in ADDRESSES in this preamble.

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 contains no information collection requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

We have analyzed this rule under Executive Order 13132, Federalism, and have 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 unfunded mandate costs. This rule will not impose an unfunded mandate.

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 create 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 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.

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.

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. The Coast Guard for good cause finds that, under 5 U.S.C. 553(b)(B) and (d)(3), notice and public comment on the rule before the effective date of the rule and advance publication are impracticable and contrary to public interest. Immediate action is necessary to ensure the safety of life, property, the environment, as well as safe passage for vessels transiting this area. The conduct of notice and comment rulemaking proceedings and compliance with advance notice requirements present significant public safety concerns that outweigh the public interest in compliance with these provisions. Public rulemaking proceedings and advance publication could provoke consequences that would pose a risk of harm to the public, military personnel, and law enforcement personnel charged with enforcement of the security zone. This regulation is geographically limited and is in effect for such a limited duration so as to meet the needs of national security while presenting a minimal burden on the public.

This security zone is required to ensure the security of the Snell and Eisenhower locks as a result of the terrorist attacks on the United States on September 11, 2001. Use of these locks is vital to national security. Pursuant to this regulation, no vessel or person will be allowed to enter, transit through, or anchor in the security zone unless specifically authorized by the District Commander, the Captain of the Port Buffalo (COTP), or one of the Captain of the Port's designated representatives. The Captain of the Port or one of his designated representatives can be reached on Marine Channel 16.

The security zone encompasses the area beginning at a line drawn from 44°59.17′ N, 74°46.01′ W; to 44°59.49′ N, 74°46.01′ W. These coordinates are on opposite sides of the Wiley-Dondero Canal 100 yards inland from the shoreline. The security zone then proceeds in a westerly direction, encompassing all waters in the canal and land 100 yards inland from the shoreline, along the Wiley-Dondero Canal past the Snell and Eisenhower Locks, to a line drawn from 44°58.75′ N, 74°52.35′ W; to 44°58.14′ N, 74°52.28′ W (NAD 83). These coordinates are on opposite sides of the Wiley-Dondero Canal 100 yards inland from the shoreline. The security zone does not include any portion of the Grasse River.

This security zone is established pursuant to the authority of Subpart D of part 165 of Title 33 of the Code of Federal Regulations and the Magnuson Act regulations promulgated by the President under 50 U.S.C. 191, including subparts 6.01 and 6.04 or part 6 Title 33 of the Code of Federal Regulations. See Executive Order 10173, as amended. The security zone is needed to protect persons, transiting vessels, adjacent waterfront facilities, and the adjacent land of the St. Lawrence River from a line approximately one-half mile east of the Snell Lock to a line approximately one mile west of the Eisenhower Lock, including all waters of the Wiley-Dondero Canal between the locks, in Massena, New York.

Vessels or persons violating this section are subject to the penalties set forth in 50 U.S.C. 192: seizure and forfeiture of the vessel, a monetary penalty of not more than $250,000, and imprisonment for not more than 10 years.

This temporary 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. It has not been reviewed by the Office of Management and Budget 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 security zone covers a vital portion of the St. Lawrence River transited by commercial vessels and is being created to protect the Snell and Eisenhower locks. In addition, the security zone is necessary to ensure the safety of land and adjacent waterfront facilities. The Coast Guard does foresee minor interruption to the passage of vessels through this area. While vessels will need authorization to transit the zone, the Coast Guard expects minimal interference with or delay in their passage.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) the Coast Guard considered whether this rule will have a significant impact on a substantial number of small businesses and not-for-profit organizations that are not dominant in their respective fields, and government jurisdictions with populations less than 50,000.

The Coast Guard certifies under section 605(b) that this temporary final 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 the St. Lawrence River up-river, between, and down-river of the Snell and Eisenhower Locks immediately until terminated by COTP Buffalo.

This security zone will not have a significant economic impact on a substantial number of small entities for the following reasons. Vessel traffic will be allowed to pass through the zone after obtaining permission of the COTP or his designated on scene representative.

Under section 213(a) of the small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding this rule so that they can better evaluate its effectiveness and participate in the rulemaking process. If your small business or organization is affected by this rule, and you have questions concerning its provisions or options for compliance, please contact the office listed in ADDRESSES in this preamble.

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 contains no information collection requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

We have analyzed this rule under Executive Order 13132, Federalism, and have 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 unfunded mandate costs. This rule will not impose an unfunded mandate.

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 create an environmental risk to health or risk to safety that may disproportionately affect children.

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

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

On July 17, 2001 (66 FR 37204), EPA proposed to approve the removal of the following rule from the Arizona SIP.

We proposed to approve the rescission of this rule because we determined that it was consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. Our proposed action contains more information on the rule and our evaluation.

EPA's proposed action provided a 30-day public comment period. During this period, we did not receive any comments.

Our assessment that the submitted rule rescission complies with the relevant CAA requirements has not changed. Therefore, as authorized in section 110(k)(3) of the Act, EPA is fully approving the removal of this rule from the Arizona SIP.

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 Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 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).)

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

On June 26, 2001 (6 FR 33930), EPA proposed a disapproval of the following rule submitted by CARB for incorporation into the SIP.

We proposed a disapproval of Rule 401 because provisions of Rule 401 conflict with section 110 and part D of the Act and prevent full approval of this SIP revision. First, given the section 189 RACM requirement, Rule 401 should not grandfather existing sources as it does at section B.3. Second, California has not submitted the sections of the Health and Safety Code (HSC) cited in section C for SIP inclusion. Consequently, EPA can neither review, nor act on these incorporations by reference. While one remedy would be to include the full text of the desired exemptions within the rule, they would be subject to EPA review and approval. Finally, section 42350 of the HSC allows for variances to a district's opacity limits. We object to these variance provisions because they provide broad discretion to modify the SIP in violation of CAA sections 110(i), 110(l), and 193.

EPA's proposed action provided a 30-day public comment period. During this period, we received no comments concerning our proposed disapproval of Rule 401.

No comments were submitted in response to our proposed action on Rule 401 and our assessment of the rule remains unchanged. Therefore, as authorized in sections 110(k)(3) and 301(a) of the Act, EPA is finalizing this disapproval of Rule 401. Our action preserves the versions of Rule 401 & 402 approved in 1989 within the federally approved SIP. These rules remain federally enforceable. As a result, this disapproval action does not trigger sanctions or Federal Implementation Plan time clocks under section 179 of the CAA.

The Office of Management and Budget has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

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)) because it is not a significant regulatory action under Executive Order 12866.

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. 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.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

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, as specified in Executive Order 13132, because it merely acts on a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), 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 final rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

EPA's disapproval of the state request under section 110 and subchapter I, part D of the Clean Air Act does not affect any existing requirements applicable to small entities. Any pre-existing federal requirements remain in place after this disapproval. Federal disapproval of the state submittal does not affect state enforceability. Moreover, EPA's disapproval of the submittal does not impose any new Federal requirements. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action acts on pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

EPA believes that VCS are inapplicable to today's action because it does not require the public to perform activities conducive to the use of VCS.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This rule is not a “major” rule as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 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).)

Throughout this document, the terms “you” and “me” refer to the reader of this proposed rulemaking and to sources subject to the State rule addressed by this proposed rulemaking, and the terms “we,” “us,” or “our” refer to the EPA.

Section 110 of the Clean Air Act (Act or CAA) requires states to develop air pollution control regulations and strategies to ensure that state air quality meets the national ambient air quality standards established by the EPA. Each state must submit the regulations and emission control strategies to the EPA for approval and promulgation into the federally enforceable SIP.

Each federally approved SIP protects air quality primarily by addressing air pollution at its points of origin. The SIPs can be and generally are extensive, containing many state regulations or other enforceable documents and supporting information, such as emission inventories, monitoring documentation, and modeling (attainment) demonstrations.

In order for state regulations to be incorporated into the federally enforceable SIP, states must formally adopt the regulations and emission control strategies consistent with state and federal requirements. This process generally includes public notice, public hearings, public comment periods, and formal adoption by state-authorized rulemaking bodies.

Once a state has adopted a rule, regulation, or emissions control strategy it submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed federal action on the state submission. If we receive adverse comments we address them prior to any final federal action (we generally address them in a final rulemaking action).

The EPA incorporates into the federally approved SIP all state regulations and supporting information it has approved under section 110 of the Act. Records of such SIP actions are maintained in the Code of Federal Regulations (CFR) at title 40, part 52, titled “Approval and Promulgation of Implementation Plans.” The actual state regulations the EPA has approved are not reproduced in their entirety in the CFR, but are “incorporated by reference,” which means that EPA has approved a given state regulation (or rule) with a specific effective date.

Enforcement of a state rule before and after it is incorporated into a federally approved SIP is primarily a state responsibility. After the rule is federally approved, however, the CAA authorizes the EPA to take enforcement actions against violators. The CAA also offers citizens legal recourse to address violations, as provided in section 304 of the Act.

In a letter dated June 8, 2000 to Francis X. Lyons, Regional Administrator, Lori F. Kaplan, Commissioner, Indiana Department of Environmental Management, submitted amendments to the Indiana I/M rule as a SIP revision. These amendments revise portions of the I/M requirements in Lake/Porter Counties (Hammond, Gary, East Chicago) and Clark/Floyd Counties (Louisville area) in Indiana. Among the most significant changes being made to the program are: the exemption of the current calendar year model vehicles plus the three previous model year vehicles from emission testing; the inclusion of language that allows the use of the IM93 alternative vehicle emission test currently being used in the program; language that updates the requirement to test vehicles equipped with second generation on-board diagnostics systems (OBDII); and the elimination of the off-cycle test, which is the emission test currently required when there is a change in possession of motor vehicle titles. In addition, a number of minor administrative changes are also included. On June 28, 2001, we published a Notice of Proposed Rulemaking (NPR) to approve the SIP revision request. The public comment period was open through July 30, 2001, and EPA received no comments. This Federal Register document takes final action to approve the June 8, 2000 SIP revision submittal.

The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in our proposal published June 28, 2001, these revisions meet the substantive SIP requirements on the CAA including I/M program requirements addressed in 40 CFR part 51, subpart S. In the June 28 proposal, we discussed in detail how the state's submittal meets each of the relevant requirements of the I/M rule and EPA's rationale for approval. The reader is referred to that discussion for the rationale of this final action.

The EPA is approving Indiana's I/M SIP revision submitted by Indiana on June 8, 2000. The SIP revision amends certain program elements of Indiana's motor vehicle inspection and maintenance requirements.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”(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 Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings' issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. 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. 804(2). This rule will be effective October 29, 2001.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 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).)

Regulated entities. Entities that will potentially be affected by this correction are those that store or transport natural gas and are major sources of HAP as defined in section 112 of the Clean Air Act. The regulated categories and entities include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that we are now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility, company, business, organization, etc., is regulated by this action, you should carefully examine the applicability criteria in § 63.1270 of the natural gas transmission and storage facilities NESHAP. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

World Wide Web (WWW). The text of today's document will also be available on the WWW through the Technology Transfer Network (TTN). Following signature, a copy of this action will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various areas of air pollution control. If more information regarding the TTN is needed, call the TTN HELP line at (919) 541-5384.

Today's action consists of one error correction to the natural gas transmission and storage facilities NESHAP technical corrections notice that was published on June 29, 2001 (66 FR 34548). This error correction is minor in nature and noncontroversial.

This correction is being made to reinstate a portion of the first sentence in § 63.1270(a) that was mistakenly deleted during the editing process for the June 29, 2001 technical corrections. Reinstatement of this language will make it clear that the natural gas transmission and storage facilities NESHAP only applies to natural gas transmission and storage facilities that are major sources of HAP, and that transmission and storage systems are subject to the rule up to a final end user only when a local distribution company is not present.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget (OMB). Because the EPA has made a “good cause” finding that this action is not subject to notice and comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of the UMRA. This action also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 6, 2000). This technical correction does not have substantial direct effects on the States, or on the relationship between the national government and the States, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This technical correction also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically significant.

This technical correction action does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995 (15 U.S.C. 272) do not apply. This technical correction also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). In issuing this technical correction, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of this rule correction 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 technical correction 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 EPA's compliance with these statutes and Executive Orders for the underlying rule is discussed in the June 17, 1999 Federal Register document containing the Oil and Natural Gas Production final rule and Natural Gas Transmission and Storage final rule (64 FR 32610).

This technical correction is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

The Congressional Review Act (CRA) (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. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement (5 U.S.C. 808(2)). As stated previously, EPA has made such a good cause finding, including the reasons therefor, and established an effective date of September 27, 2001. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action 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_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301169. 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 insecticide bifenthrin, [(2-methyl [1,1'-biphenyl] -3-yl) methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate], in or on sweet potato at 0.05 part per million (ppm). This tolerance will expire and is revoked on December 31, 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.

EPA has authorized under FIFRA section 18 the use of bifenthrin on sweet potato for control of the sweet potato weevil and beetle in the states of Mississippi and Louisiana. After having reviewed the submission, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of bifenthrin in or on sweet potato. 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 December 31, 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 sweet potato 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 bifenthrin meets EPA's registration requirements for use on sweet potato 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 bifenthrin by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any States other than Mississippi and Louisiana 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 bifenthrin, 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 bifenthrin and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for residues of bifenthrin in or on sweet potato at 0.05 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 (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for bifenthrin 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 180.442) for the residues of bifenthrin, in or on the following raw agricultural commodities: Globe artichoke; brassica, head and stem subgroup excluding cabbage; cabbage; caneberry subgroup; corn; cottonseed; eggplant; grape; head lettuce; pea and bean succulent shelled subgroup; pepper (bell and non-bell); rapeseed; strawberries; cucurbit vegetable crop group; and edible podded legume vegetable subgroup. Egg; fat, meat by product, and meat of cattle, goats, hogs, horses, poultry and sheep; and milk fat tolerances have also been established for bifenthrin. Time-limited tolerances under section 18 currently exists for grapes and peanuts (nutmeats) and are set to expire on December 31, 2001. Additional tolerances also include citrus (dried pulp, oil, whole fruit) and potato, and are set to expire on December 31, 2003. Risk assessments were conducted by EPA to assess dietary exposures from bifenthrin 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 one day or single exposure. The Dietary Exposure Evaluation Model (DEEM) analysis evaluated the individual food consumption as reported by respondents in the USDA (1994-1996) 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: A probabilistic Monte Carlo analysis (Tier 3) was used. PCT (% crop treated) and anticipated residues were used for registered crops, and 100% crop treated was used for all other unregistered crops.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEM analysis evaluated the individual food consumption as reported by respondents in the USDA (1994-1996) nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: In conducting this new DEEM analysis for the chronic dietary (food only) risk assessment, the agency used anticipated residue values which were determined from field trial data conducted at maximum label conditions of maximum application rates and minimum preharvest intervals. Mean anticipated residue values were calculated. 100% crop treated was assumed for all crops except hops (43%) and cottonseed-oil and cottonseed-meal (4%).

iii. Cancer. Bifenthrin has been classified as a Group C chemical (possible human carcinogen) based upon urinary bladder tumors in mice. No Q* was assigned because the RfD approach was recommended for cancer risk assessment. Based on this recommendation, a quantitative dietary cancer risk assessment was not performed since dietary risk concerns due to long-term consumption of bifenthrin are adequately addressed by the chronic exposure analysis using the RfD.

iv. 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; and 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.43% hops, and 4% cottonseed-oil and cotton-meal

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 under estimate 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 bifenthrin may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for bifenthrin 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 bifenthrin.

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 bifenthrin they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models, EECs for bifenthrin acute and chronic exposure for surface water are estimated to be 0.1 parts per billion (ppb) and 0.032 (average 56-day) ppb, respectively. The ground water screening concentration is 0.006 ppb. These values represent upper-bound estimates of the concentrations that might be found in surface water and ground water from the highest application rate for bifenthrin, 0.5 lb ai/A, used on cotton.

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).

Bifenthrin is currently registered for use on the following residential non-dietary sites: Lawn for flea infestation control, and residential flowable insecticide/miticide. Under current EPA guidelines, these uses do not present a chronic exposure scenario, but may constitute a short- and/or intermediate-term exposure scenario. A residential exposure assessment for the lawn care uses of bifenthrin was conducted in conjunction with the “Risk Assessment for Extension of Tolerances for Synthetic Pyrethroids.”

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 bifenthrin 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, bifenthrin 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 bifenthrin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

2. Developmental toxicity studies. In a rabbit developmental toxicity study, there were no developmental effects observed in the fetuses exposed to bifenthrin. The maternal NOAEL was 2.67 milligram/kilogram/day (mg/kg/day) based on head and forelimb twitching at the LOAEL of 4 mg/kg/day.

In the rat developmental study, the maternal NOAEL was 1 mg/kg/day, based on tremors at the LOAEL of 2 mg/kg/day. The developmental (pup) NOAEL was also 1 mg/kg/day, based upon increased incidence of hydroureter at the LOAEL of 2 mg/kg/day. There were 5/23 (22%) of the litters affected (5/141 fetuses since each litter only had one affected fetus) in the 2 mg/kg/day group, compared with zero in the control, 1, and 0.5 mg/kg/day groups. According to recent historical data (1992-1994) for this strain of rat, background incidence of distended ureter averaged 11% with a maximum incidence of 90%.

3. Reproductive toxicity study. In the rat reproduction study, parental toxicity occurred as decreased body weight and tremors at 5.0 mg/kg/day with a NOAEL of 3.0 mg/kg/day. There were no developmental (pup) or reproductive effects up to 5.0 mg/kg/day (highest dose tested).

4. Prenatal and postnatal sensitivity—i. Prenatal. Since there was not a dose-related finding of hydroureter in the rat developmental study and in the presence of similar incidences in the recent historical control data, the marginal finding of hydroureter in rat fetuses at 2 mg/kg/day (in the presence of maternal toxicity) is not considered a significant developmental finding. Nor does it provide sufficient evidence of a special dietary risk (either acute or chronic) for infants and children which would require an additional safety factor.

ii. Postnatal. Based on the absence of pup toxicity up to dose levels which produced toxicity in the parental animals, there is no evidence of special postnatal sensitivity to infants and children in the rat reproduction study.

5. Conclusion. There is a complete toxicity data base for bifenthrin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10x safety factor to protect infants and children should be removed. Based on the above, EPA concludes that reliable data support use of the standard 100-fold uncertainty factor, and that an additional uncertainty factor is not needed 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 US EPA Office of Water are used to calculate DWLOCs: 2Liters/70 kilograms (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 bifenthrin 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 bifenthrin on drinking water as a part of the aggregate risk assessment process.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to bifenthrin will occupy 60% of the aPAD for the U.S. population, 40% of the aPAD for females 13 years and older, 75% of the aPAD for all infants <1 year old and 99.7% of the aPAD for children (1-6 years old). In addition, despite the potential for acute dietary exposure to bifenthrin in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of bifenthrin 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 bifenthrin from food will utilize 3% of the cPAD for the U.S. population, 3% of the cPAD for females 13 years and older and 8.2% of the cPAD for children (1-6 years old). Based the use pattern, chronic residential exposure to residues of bifenthrin is not expected. In addition, despite the potential for chronic dietary exposure to bifenthrin in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of bifenthrin 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- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Bifenthrin is currently registered for use(s) that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for bifenthrin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 940 for adults, 350 for children (1-6 yrs old), and 470 for infants < 1 yr old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of bifenthrin 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. Aggregate cancer risk for U.S. population. Bifenthrin has been classified as a Group C chemical (possible human carcinogen) based upon urinary bladder tumors in mice. No Q* was assigned because the RfD approach was recommended for cancer risk assessment. Based on this recommendation, a quantitative dietary cancer risk assessment was not performed since dietary risk concerns due to long-term consumption of bifenthrin are adequately addressed by the chronic exposure analysis using the RfD. Based on a comparison of the calculated DWLOCs and the estimated exposure to bifenthrin in drinking water, the agency does not expect the chronic aggregate exposure to exceed 100% of the cPAD (cRfD) for adults. Thus, EPA concludes with reasonable certainty that the carcinogenic risk is within acceptable limits.

5. 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 bifenthrin residues.

Adequate enforcement methodology 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.

Therefore, the tolerance is established for residues of bifenthrin, [(2-methyl [1,1'-biphenyl] -3-yl) methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate], in or on sweet potato at 0.05 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-301169 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 26, 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-301169, 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). 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). 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 prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 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).

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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person. The Agency has established an official record for this action under docket control number OPP-301167. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m.to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for combined residues of the herbicide cyhalofop-butyl, 2-[4-(4-cyano-2-fluorophenoxy)phenoxyl]-propanoic acid, butyl ester (R) plus the cyhalofop-acid and di-acid metabolites, in or on rice grain at 0.03 part per million (ppm) and rice straw at 8.0 ppm. These tolerances will expire and are revoked on June 30, 2002. 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 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.

Weeds cause economic damage by competing with rice plants for soil, nutrients and sunlight, and by interfering with harvesting equipment. Bearded sprangletop is one of the most important grass weeds in California rice. The California Rice Research Board surveyed growers in 1999, and found that more than half reported an increasing trend in sprangletop infestation, while only 4% thought the weed was decreasing. The remainder called the weed populations “variable” or “stable.”

As for impacts on yield, the University of California Cooperative Extension Service in 1999 conducted trials to investigate a link between sprangletop infestations and yield loss. The UC found that a 50% sprangletop cover results in yield losses ranging from 20% to as high as 60%.

In 2000, Rice Researchers, Inc. measured yield impacts of sprangletop at levels of infestation ranging from 1-3 plants per square meter to 25-30 plants per square meter. In three replications it was shown that yields were impacted as much as 25%.

The following conditions give rise to sprangletop infestations in California leading to yield losses: (1) thiobencarb cannot be applied to soils with Delayed Phytotoxicity Syndrome (DPS); (2) water management practices (BMPs) necessary for the protection or promotion of the rice that incidentally lead to heavier weed infestations; and (3) the lack of suitable herbicides that are effective under all conditions.

EPA has authorized under FIFRA section 18 the use of cyhalofop-butyl on rice for control of Bearded sprangletop 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 cyhalofop-butyl in or on rice. 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, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on rice grain or rice straw 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 cyhalofop-butyl meets EPA's registration requirements for use on rice or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of cyhalofop-butyl by a State for special local needs under FIFRA section 24(c). Nor do these tolerances 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 cyhalofop-butyl, 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 cyhalofop-butyl and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for combined residues of cyhalofop-butyl plus the cyhalofop-acid and di-acid metabolites in or on rice grain at 0.03 ppm and rice straw at 8.0 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows.

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 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 cyhalofop-butyl used for human risk assessment is shown in the following Table 1.

1. Dietary exposure from food and feed uses. Cyhalofop-butyl is a new chemical, this is the first tolerance established for the combined residues of cyhalofop-butyl plus the cyhalofop-acid and di-acid metabolites, in or on a raw agricultural commodity (rice grain and rice straw). Risk assessments were conducted by EPA to assess dietary exposures from cyhalofop-butyl 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 one day or single exposure. An appropriate endpoint attributable to a single exposure (dose) was not identified in any study including the acute neurotoxicity study or developmental toxicity studies. Therefore, acute dietary risk assessments were not conducted.

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

iii. Cancer. The Agency has not yet classified cyhalofop-butyl for cancer. A combined chronic toxicity/carcinogenicity study in rats and a carcinogenicity study in mice were conducted to assess the carcinogenic potential of cyhalofop-butyl. At the doses tested, there was no treatment-related increase in tumor incidence when compared to controls.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for cyhalofop-butyl 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 cyhalofop-butyl.

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 cyhalofop-butyl they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of cyhalofop-butyl for chronic exposures are estimated to be 4 parts per billion (ppb) for surface water and 0.016 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). Cyhalofop-butyl 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 cyhalofop-butyl 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, cyhalofop-butyl 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 cyhalofop-butyl has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

2. Developmental toxicity studies. In a developmental toxicity study in rats the maternal toxicity NOAEL is 1,000 mg/kg/day (limit dose). At the 1,000 mg/kg/day treatment level, the liver to body weight ratio and the liver to adjusted body weight ratio were both increased (106-107% of controls; p <0.01), and there were slight, non-statistical increases in the mean absolute liver weights of all treated groups; however, these increases can be attributed to enzyme induction as an adaptive response to a xenobiotic agent rather than a treatment-related adverse effect. There were no treatment-related effects observed at 25 and 250 mg/kg/day. The developmental toxicity NOAEL is greater than or equal to 1,000 mg/kg/day (limit dose).

In a developmental toxicity study in rabbits the maternal LOAEL is 200 mg/kg/day based on maternal death. The maternal NOAEL is 40 mg/kg/day. The developmental NOAEL is greater than or equal to 1,000 mg/kg/day (limit test).

3. Reproductive toxicity study. In a 2-generation reproduction study in rats no treatment-related deaths, clinical signs, body weight changes, or food consumption differences were observed for parental male or female rats in either generation administered any dose of the test material. No effects were observed for F0 or F1 females during gestation or lactation. The Reproductive NOAEL is greater than or equal to 1,000 ppm (50.1-138.7 mg/kg/day for males; 69.2-147.7 mg/kg/day for females, highest dose tested (HDT)) and the Offspring NOAEL is greater than or equal to 1,000 ppm (50-147.7 mg/kg/day, HDT).

4. Neurotoxicity studies. In an acute neurotoxicity study in rats the NOAEL is greater than or equal to 2,000 mg/kg (limit dose) based on the absence of clinical signs, a lack of effects on FOB parameters and motor activity, and the absence of neuropathologic lesions following gavage dosing.

In a subchronic neurotoxicity study in rats the NOAEL is greater than or equal to 75 mg/kg/day HDT in males and greater than or equal to 250 mg/kg/day (HDT) in females based on the absence of clinical signs, lack of effects on FOB parameters and motor activity, and absence of neuropathologic lesions.

5. Conclusion. There is no evidence of quantitatively or qualitatively increased susceptibility in the developmental toxicity studies in rats and rabbits, or in the two generation reproductive toxicity study in rats. However, cyhalofop-butyl has not been evaluated by the Agency's FQPA Safety Factor Committee. Therefore, for the purposes of this emergency exemption, the FQPA safety factor of 10X, to protect infants and children has been retained for all dietary and residential risk assessments.

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 cyhalofop-butyl 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 cyhalofop-butyl on drinking water as a part of the aggregate risk assessment process.

1. Acute risk. An appropriate endpoint attributable to a single exposure (dose) was not identified in any study including the acute neurotoxicity study or developmental toxicity studies. Therefore, acute dietary risk assessments were not conducted.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to cyhalofop-butyl from food will utilize less than 1% of the cPAD for the U.S. population, 4% of the cPAD for non-nursing infants (infant subpopulation at greatest exposure) and 2% of the cPAD for children 1-6 years old (children subpopulation at greatest exposure. There are no residential uses for cyhalofop-butyl. In addition, despite the potential for chronic dietary exposure to cyhalofop-butyl in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of cyhalofop-butyl in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2:

3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Cyhalofop-butyl 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). Cyhalofop-butyl 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. The Agency has not yet classified cyhalofop-butyl for cancer. A combined chronic toxicity/carcinogenicity study in rats and a carcinogenicity study in mice were conducted to assess the carcinogenic potential of cyhalofop-butyl. At the doses tested, there was no treatment-related increase in tumor incidence when compared to controls. Therefore, a risk assessment to estimate risk from cancer was not conducted.

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 cyhalofop-butyl residues.

Adequate enforcement methodology 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 is neither a Codex proposal, nor Canadian or Mexican limits, for residues of cyhalofop-butyl and its metabolite in or on rice. Therefore, harmonization is not an issue for this use.

Therefore, the tolerance is established for combined residues of cyhalofop-butyl, 2-[4-(4-cyano-2-fluorophenoxy)phenoxyl]propanoic acid, butyl ester (R) plus the cyhalofop-acid and di-acid metabolites in or on rice grain at 0.03 ppm and rice straw at 8.0 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-301167 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 26, 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-301167, 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 time-limited tolerances 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). 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). 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

The AGAR implements the FAR (48 CFR chapter 1) where further implementation is needed, and supplements the FAR when coverage is needed for subject matter not covered by the FAR. On July 26, 2000, the FAR was amended to employ NAICS codes for small business size determinations and other purposes in lieu of SIC codes (65 FR 46055-46063). AGAR 452.219-70, a solicitation provision prescribed for use by AGAR 419.508, informs prospective offerors which small business size standards will be used in determining whether an offeror is a large business or a small business. The provision sets out size standards by SIC code. We are amending this provision and prescription to use NAICS codes to identify business classifications and applicable size standards. In this rulemaking document, USDA is amending the AGAR as a direct final rule, since the changes are non-controversial and unlikely to generate adverse comment.

Rules that an agency believes are noncontroversial and unlikely to result in adverse comments may be published in the Federal Register as direct final rules. The Office of Procurement and Property Management published a policy statement in the Federal Register (63 FR 9158, Feb. 24, 1998) notifying the public of its intent to use direct final rulemaking in appropriate circumstances.

This rule makes the following changes to the AGAR:

(a) In parts 419 and 452, we substitute the term “North American Industrial Classification System” and its acronym “NAICS” for the term “Standard Industrial Classification” and its acronym “SIC'.

(b) In part 452, we change the date of the solicitation provision at AGAR 452.219-70, because the provision is amended by this direct final rule.

USDA prepared a work plan for this regulation and submitted it to the Office of Management and Budget (OMB) pursuant to Executive Order No. 12866. OMB determined that the rule was not significant for the purposes of Executive Order No. 12866. Therefore, the rule has not been reviewed by OMB. USDA has reviewed this rule in accordance with Executive Order No. 12988, Civil Justice Reform. The proposed rule meets the applicable standards in section 3 of Executive Order No. 12988.

USDA reviewed this rule under the Regulatory Flexibility Act, 5 U.S.C. 601-611, which requires preparation of a regulatory flexibility analysis for any rule which is likely to have significant economic impact on a substantial number of small entities. USDA certifies that this rule will not have a significant economic effect on a substantial number of small entities, and, therefore, no regulatory flexibility analysis has been prepared. However, comments from small entities concerning the effects of the rule will be considered. Such comments must be submitted separately and cite 5 U.S.C. 609 (AGAR Case 2000-01) in correspondence.

No information collection or recordkeeping requirements are imposed on the public by this rule. Accordingly no OMB clearance is required by the Paperwork Reduction Act, 44 U.S.C. chapter 35, or OMB's implementing regulations at 5 CFR Part 1320.

A report on this rule has been submitted to each House of Congress and the Comptroller General in accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801-808. This rule is not a major rule for purposes of the Act.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. USDA has determined that this direct final rule does not contain a Federal mandate as defined in 2 U.S.C. 658(a). USDA has also determined that this direct final rule does not significantly or uniquely affect small governments. Accordingly, this rule is not subject to the requirements of Title II of UMRA.

Executive Order 13132, Federalism (64 FR 43255, Aug. 10, 1999), imposes requirements 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.”

USDA has determined that this rule does not have federalism implications. It 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, as specified in Executive Order 13132. The rule will not impose substantial costs on States and localities. Accordingly, this rule is not subject to the procedural requirements of Executive Order 13132 for regulatory policies having federalism implications.

Executive Order 13175, Consultation and Coordination with Indian Tribal Governments (65 FR 67249, Nov. 9, 2000), imposes requirements in the development of regulatory policies that have tribal implications. Executive Order 13175 defines “policies that have tribal implications” as having “substantial direct effects 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.” USDA has determined that this rule does not have tribal implications and, therefore, the consultation and coordination requirements of Executive Order 13175 do not apply.

This Federal Register document is also accessible via the Internet at the Office of the Federal Register’s website at http://www.access.gpo.gov/su-docs/aces/aces140.html. -

The United States is a member of the IATTC, which was established under the Convention for the Establishment of an Inter-American Tropical Tuna Commission, signed in 1949. The IATTC was established to provide an international arrangement to ensure conservation and management of yellowfin tuna and of other fish species taken by tuna fishing vessels in the EPO (also known as the Convention Area), defined at 50 CFR part 300, subpart C, as the waters bounded by the coast of the Americas, 40° N. lat., 150° W. long., and 40° S. lat. The IATTC maintains a scientific research and fishery monitoring program, which annually assesses the status of tuna stocks and conditions in the fisheries to determine appropriate harvest levels or other measures to prevent overexploitation and promote maximum sustainable yield. The IATTC is devoting an increased amount of time and resources to assessing the need for, and recommending, conservation and management measures to deal with problems such as bycatch in the tuna fisheries. -

The actions in this final rule are intended to address concerns about bycatch in purse seine fisheries in the EPO and to establish a regional vessel register that will be useful for compliance monitoring and for management decisions affecting the many fishing gears used in the EPO to take tuna and tuna-like fishes. These measures were recommended by the IATTC and approved by the DOS. The preamble to the proposed rule published for this action (66 FR 17387, March 30, 2001, corrected at 66 FR 20419, April 23, 2001) presented the history and provisions of the action, and they are not repeated here. Pursuant to the Tuna Conventions Act, NMFS convened a public hearing on the proposed rule in San Diego, California, on April 27, 2001. -

Several clarifications to the language contained in the proposed rule were made based on comments and recommendations that NMFS received. -

Comment 1: The rule fails to address over-capacity and overfishing. -

Response: The recommendations of the IATTC did not address these issues; therefore, the rule, which is intended to carry out the IATTC recommendations, does not address them. The IATTC staff has been charged with developing a fleet capacity program consistent with the Food and Agricultural Organization Plan of Action for fishing capacity management. -

Comment 2: The IATTC member nations are not enforcing the IATTC recommendations. -

Response: The U.S. agrees that there is concern about the uneven level of enforcement among the members and is working with them to improve this situation. A new permanent Working Group on Compliance was established and met for the first time in June 2000. Reports on the implementation of, and compliance with, IATTC recommendations will be among priority subjects for future meetings of this working group. The working group discussions should result in increased peer pressure to improve enforcement and compliance by all members. -

Comment 3: The proposed rule fails to implement time and area closures, which would be more effective in reducing bycatch. -

Response: Time and area closures are only one of several possible tools to limit bycatch, especially of juvenile tuna. The 2000 resolution, which sets the quota for yellowfin tuna included two area closures that would go into effect when the purse seine catch reached 240,000 metric tons. These were intended to ensure that juvenile yellowfin catches (which are historically higher in these areas) would be curtailed if the total yellowfin catch were high. However, catches were slow the second half of 2000, and the closures were not needed. The IATTC also agreed to and the parties implemented a 90-day closure of the purse seine fishery on floating objects (any natural object or manmade fish aggregating device around which fishing vessels may catch tuna) from September 15, 2000, to December 15, 2000. The goal of this closure was to reduce the probability of high catches of juvenile yellowfin and bigeye tuna. End-of-year data indicate that catches of juvenile tuna were indeed relatively low. -

Comment 4: The bycatch reduction provisions should be extended to all gear types that fish in the EPO. -

Response: The IATTC has historically focused on managing the tuna purse seine fisheries, which account for the bulk of tuna fishing and fishing mortality in the EPO. However, the IATTC is aware of the need to consider other fishing gears in the future. The regional vessel register should provide the initial data on the degree to which other gears are used. For the time being, however, the IATTC only recommended actions dealing with bycatch reduction in the purse seine fishery, and therefore, the proposed rule could only deal with those recommendations. However, the Pacific Fishery Management Council (Council) is preparing a fishery management plan (FMP) for highly migratory species fisheries off the West Coast. The FMP will contain management measures that, to the extent practicable, minimize bycatch and, to the extent bycatch cannot be avoided, minimize the mortality of such bycatch. -

Comment 5: The bycatch rule should last longer than 1 year. -

Response: The IATTC’s initial recommendation called for only a 1-year pilot project. At its meeting in June 2001, however, the IATTC agreed to extend the pilot project through 2002. -

Comment 6: The terms of reference for the evaluation of the effectiveness of the pilot program should be made available for review and comment. -

Response: The IATTC did not establish terms of reference for the evaluation; therefore, they are not available at this time. However, NMFS and the DOS expect the review to include the extent of application by the parties, the records of observers from initial trips (indicating both the degree of compliance and the degree of difficulties that operators may have had in implementing the measure), and the records of the amount of fish, by species and size, that were retained and discarded. Only very preliminary results were discussed at the annual meeting in June, and it was agreed that first year results would be discussed at a Bycatch Working Group meeting early in 2002. The Bycatch Working Group meetings are open to the public, and the IATTC often posts analytical results on its website. -

Comment 7: The recordkeeping and reporting requirements did not explicitly list all the information listed in the IATTC Resolution. -

Response: NMFS intends to provide to the IATTC all the data elements listed in the IATTC Resolution. NMFS already has (or has access to) much of the information needed, and will only request missing data elements from individual vessel owners. The rule requires owners to provide such information as requested by the Regional Administrator. Also, the IATTC may change the data elements needed in the future. The approach contained in the rule should allow NMFS to implement new recommendations in the future without going through additional rulemaking, although Paperwork Reduction Act (PRA) requirements will apply. -

Comment 8: The rules fail to address alternative means of harvesting free-swimming mature tuna. -

Response: NMFS appreciates the many suggestions it received concerning research and testing of alternative technological innovations that can locate and harvest mature yellowfin tuna not associated with dolphins or significant bycatch, and has provided these suggestions to the NMFS Southwest Fisheries Science Center and IATTC staff for consideration. However, since neither the IATTC recommends, nor the Tuna Convention Act mandates, the use of alternative measures for locating and harvesting mature tuna, the rule cannot require them under the Tuna Conventions Act. -

Comment 9: NMFS should have prepared an environmental impact statement (EIS) for the proposed rule. -

Response: The proposed measures are limited in scope and time, and fewer than 30 U.S. vessels are likely to be affected by this rule. Therefore, NMFS has determined that an EIS is not necessary. However, NMFS has considered the comments on this rule and modified accordingly the EA for this action. -

Comment 10: The EA is inadequate in several ways: It did not take into consideration all information before it made an unwarranted conclusion that the yellowfin stock is healthy; it did not contain an examination of the effect of bycatch reduction efforts on dolphins; and it did not take into consideration that finfish and sharks released from purse seine nets will already be dead. Further, the EA should not have been separated from the programmatic EA for the implementation of the International Dolphin Conservation Program Act (IDCPA). -

Response: NMFS agrees that the actions are related, in that both EAs address management of the U.S. purse seine fleet in the EPO. However, this rule was adopted independently of the actions under the IDCPA. The final EA for this action refers to the EA for the IDCPA to the extent necessary. -

Comment 11: The term “discard” should be defined or clarified to prevent a vessel operator from circumventing the intent of the measure by dumping dead fish from a net before bringing them on board. The intent of the measure was “full retention” of all tuna caught in a set. -

Response: The prohibition on discarding tuna (other than those unfit for human consumption) has been revised to match the language of the IATTC recommendation, which provides the circumstances under which fish should be discarded. NMFS agrees that, under this rule, a vessel operator could abort a set or terminate brailing of fish on board if it was determined that there was a large amount of small tuna or non-tuna species with little market value. If a substantial number of these fish survive, then aborting the set would be beneficial. This is one of the factors that should be considered by the IATTC in evaluating the pilot program. -

Comment 12: The term “as soon as practicable”, as used in §§ 300.28 and 300.29 of this chapter should be defined for clarification. -

Response: The language in §§ 300.28 and 300.29 has been revised to clarify the term “as soon as practicable.” Non-target species of fish must be returned to the sea as soon as practicable after the fish have been brought on board the vessel during the brailing operation and identified. -

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

NMFS prepared a FRFA describing the impact of this action on small entities. For the 2001 fishing year, the final rule requires: (1) Full retention of all tuna taken in a set and brought on board a fishing vessel, except on the last set when there might not be sufficient well space to accommodate all tuna in a set; (2) the prompt release of non-target species; and (3) the use of special procedures to release sea turtles with a minimum of injury, and to reduce overall sea turtle mortality. These measures should not have significant economic impacts. Requiring fishermen to retain all tuna caught may force the fishermen to retain fish with little market value (due to small size), resulting in lower income per trip. However, this also should result in faster filling of the vessel, incurring less total cost for a fishing trip. The net impact should be minimal. Furthermore, the requirement would reduce the time normally taken to sort the tuna catch by size and to discard small fish. Moreover, in the longterm, any reduction in discards and associated mortality should assist in maintaining the productivity of the stocks, which would benefit the fisheries through higher catches of large fish in the future, as the fish released at a small size may be caught in the future at a larger size. The requirement to promptly release non-target species essentially codifies current practice under which most if not all vessels release sea turtles, and would not generate additional cost to U.S. fishermen. The requirement to release non-target species would not prevent retention of occasional non-target species for consumption on the vessel. Finally, the measures to handle sea turtles with special care are already standard practice, and the measure relating to resuscitation of comatose sea turtles is already codified in the regulations at 50 CFR 223.206(d)(1)(i)(B) that implement the IDCPA. No added costs to fishermen will be generated. -

All of these measures would apply to U.S. purse seine vessels fishing for tuna in the EPO. From 1993 to 1997, the maximum number of U.S. tuna vessels active in the EPO was 35 vessels. Of these, 27 small vessels (less than 363 mt carrying capacity) are considered to be small business entities. None of the final measures would have any disproportionate economic impact on these small entities. -

With respect to information collection, the final rule would require reporting certain information about vessels if that information is not already being reported to Federal or state agencies under other programs. It is estimated that about 1,290 vessels would be involved. However, most of the information required for the IATTC register can be obtained from other sources, and the added reporting burden is estimated to average about 565 hours and $1,720 per year for 3 years. -

Two alternatives to the selected action were considered: A no action alternative and an additional action alternative. -

Under the no action alternative, U.S. regulations would be deferred until it is clear that other nations have placed restrictions on their vessels equal to those imposed by the U.S. Deferring implementation of these regulations at this time would not immediately have any impacts on fish stocks because the U.S. share of total fishing in the EPO is quite small, and U.S. fishermen generally try to avoid small fish already because of their low value. U.S. vessels currently take measures to minimize harm to sea turtles as well. However, this approach could result in serious long-term impacts if other nations viewed failure of the U.S. to implement regulations in a timely manner as a sign of disagreement with the measures recommended by the IATTC. The U.S. has obligations under the Tuna Conventions Act to implement such recommendations as are approved by the DOS. Failure of the U.S. to fulfill its obligations would weaken the ability of the U.S. to argue strongly for aggressive implementation and enforcement of IATTC recommendations by all other member nations.

Under the additional action alternative, the U.S. would go beyond the recommendations of the IATTC or take an alternative approach to the vessel register information collection. For example, NMFS might require vessels to abort sets if the first brailing of fish on board demonstrates that there is a certain percentage of fish below a given size. NMFS could perhaps also prohibit log sets (especially sets involving fish aggregating devices, or FADs) to ensure that bycatch will be reduced, as was done from September 15, 2000, through December 15, 2000. This would reduce bycatch. NMFS might also establish a separate EPO licensing program, with applications to include all the specific items of information specified in the IATTC recommendation. -

Taking additional actions would have greater impact on U.S. fleets than the proposed action. To prevent having to retain a large amount of low-value tuna, vessel operators probably would abort more sets than is now the case. This could put U.S. vessels at a disadvantage compared to foreign fleets. It is not clear that the benefits of further reductions would offset the loss of economic value associated with log set fishing. Log sets constitute a cost-effective fishing technique, and approaches other than closures or full retention may be equally effective in reducing bycatch. -

With respect to licensing, a single Federal license may be an efficient way to document who is fishing for these species in the EPO, to establish the universe of persons who would need to be contacted, and to determine whose fishing would need to be monitored in order to ensure adequate information for future management decisions. -

Neither of these alternatives was adopted. First, the Tuna Conventions Act does not provide authority for independent action to carry out more than the recommendations of the IATTC. Second, NMFS notes that the Council is preparing an FMP for U.S. fisheries involving highly migratory species off California, Oregon, and Washington. Appropriate conservation and management measures for the fisheries and licensing and reporting requirements are among the matters under consideration. NMFS believes it is more appropriate to defer action on approving a licensing and reporting program to carry out obligations under the Tuna Conventions Act until it is known which measures the Council will recommend and the basis for those recommendations. NMFS does not want to foreclose the Council’s options at this time and, therefore, rejected this alternative. -

An informal section 7 consultation under the Endangered Species Act was concluded by NMFS in October 2000, on the operation of the U.S. purse seine fishery under the terms of the IDCPA. The consultation concluded that the management measures considered would not jeopardize the continued existence of any listed species or result in the destruction or adverse modification of any identified critical habitat. The Regional Administrator has determined that fishing activities conducted pursuant to this rule will not affect endangered or threatened species or critical habitat in any manner not considered in prior consultations on this fishery. This action is within the scope of that earlier consultation, and no further consultations are necessary. -

This action is consistent with the Marine Mammal Protection Act, as amended by the IDCPA. -

This final rule contains a collection-of-information requirement subject to review and approval by OMB under the PRA. This requirement has been approved by OMB under control number 0648-0431. -

Public reporting burden for this collection is estimated to average 65-80 minutes per individual response. This includes the time for reviewing an information form provided by NMFS, checking the accuracy of the information, correcting erroneous information and providing information for empty elements on the form, and submitting the form with the picture to NMFS. Send comments regarding this burden estimate or any other aspect of the collection, including suggestions for reducing the burden, to NMFS and to OMB (see ADDRESSES). -

Notwithstanding any other provision of the law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

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

Under § 635.23 (a)(4), NMFS may increase or decrease the daily retention limit of large medium and giant BFT over a range from zero (on RFDs) to a maximum of three per vessel to allow for maximum utilization of the quota for BFT. Based on a review of dealer reports, daily landing trends, and the availability of BFT on the fishing grounds, NMFS has determined that an increase of the daily retention limit for the remainder of September through October 31, 2001 is appropriate. Therefore, NMFS adjusts the daily retention limit to two large medium or giant BFT per vessel from September 24, 2001, through October 31, 2001. Also under 50 CFR 635.23(a)(4), NMFS has determined that adjustment to the RFD schedule, and, therefore, an increase of the daily retention limit for certain previously designated RFDs, is necessary. Therefore, NMFS adjusts the daily retention limit for October 1 and 3, 2001, from zero to two large medium or giant BFT per vessel.

The intent of these adjustments is to allow for maximum utilization of the General category subquotas for the September and October-December fishing periods (specified under 50 CFR 635.27(a)) by General category participants in order to achieve optimum yield in the General category fishery, to collect a broad range of data for stock monitoring purposes, and to be consistent with the objectives of the HMS FMP.

The final initial 2001 BFT quota specifications issued pursuant to 50 CFR 635.27 set a quota of 55 mt of large medium and giant BFT to be harvested from the regulatory area by vessels permitted in the Harpoon category during the 2001 fishing year (66 FR 37421, July 18, 2001). The Harpoon category quota was adjusted on August 29, 2001, when 15 mt were transferred from the Reserve to the Harpoon category for an adjusted Harpoon category quota of 70 mt (66 FR 46400, September 5, 2001). Based on reported landings and effort, NMFS projected that this quota would be reached by September 16, 2001. Therefore, fishing for, retaining, possessing, or landing large medium or giant BFT by vessels in the Harpoon category ceased at 11:30 p.m. local time, Sunday, September 16, 2001 (66 FR 48221, September 19, 2001). Upon review of actual landings reports as of September 19, 2001, NMFS has determined that Harpoon category landings totaled approximately 68 mt. Therefore, NMFS is reopening the Harpoon category effective September 21, 2001, through May 31, 2002.

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

Annual BFT quota specifications issued under 50 CFR 635.27 provide for a quota of 55 mt of large medium and giant BFT to be harvested from the regulatory area by vessels fishing under the Harpoon category quota during the 2001 fishing year. The Harpoon category quota was adjusted on August 29, 2001, when 15 mt were transferred from the Reserve to the Harpoon category for an adjusted Harpoon category quota of 70 mt (66 FR 46400, September 5, 2001).

After considering the reopening of the Harpoon category fishery and the criteria for making transfers between categories and from the Reserve, NMFS has determined that 20 mt of the remaining 26.9 mt of Reserve should be transferred to the Harpoon category. Thus, the adjusted annual quota for the Harpoon category is 90 mt for the 2001 fishing year.

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

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

The Northwest Regional Administrator, NMFS (Regional Administrator) has determined that the commercial fishery from the Queets River, WA, to Cape Falcon, OR, should reopen for 11 days, starting August 17, 2001, and closing at midnight on August 27, 2001, with a limit of 150 chinook for this open period per boat. Modification of fishing seasons is authorized by regulations at 50 CFR 660.409 (b)(1)(i). Modification of the species that may be caught and landed during specific seasons and the establishment or modification of limited retention regulations is authorized by regulations at 50 CFR 660.409 (b)(1)(ii).

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

The U.S.-Canada Border to Leadbetter Pt. July troll fishery closed on July 9, 2001, at 2359 hours l.t.(66 FR 38573, July 25, 2001). The commercial fishery for all salmon from Queets River, WA to Cape Falcon, OR therefore started July 20, 2001.

Because of a higher than expected chinook/coho catch ratio, the commercial fishery from the Queets River, WA, to Cape Falcon, OR began July 20, 2001, under a cycle of 4 days open/3 days closed, and with a limit of 65 chinook per open period per boat (66 FR 45634, August 29, 2001). The modifications to the fishing season were adopted to avoid closing the fishery early due to reaching the chinook quota, thus precluding the opportunity to catch available marked hatchery coho salmon.

Evaluation of the catch rates during the first open period indicated that no further season modifications were necessary for the second 4 day opening (July 27-30, 2001).

Because the availability of coho salmon was increasing, the next fishing season opening was lengthened to 10 days, reopening August 3 and closing at midnight on August 12, 2001, with a limit of 100 chinook for the open period per boat (66 FR 46403, September 5, 2001).

On August 14, 2001, after the third open period, the Regional Administrator consulted with representatives of the Pacific Fishery Management Council, Washington Department of Fish and Wildlife (WDFW), and Oregon Department of Fish and Wildlife (ODFW) by conference call. The chinook/coho catch rates and effort data indicated that the availability of coho was increasing in the area while the availability of chinook was decreasing. The WDFW and ODFW recommended, and the Regional Administrator concurred, that the season would reopen August 17, 2001, for 11 days and close at midnight on August 27, 2001, with a limit of 150 chinook per boat for the entire open period. All other restrictions that apply to this fishery remain in effect as announced in the 2001 annual management measures for ocean salmon fisheries and subsequent inseason actions. A conference call with all the parties involved was scheduled for August 29, 2001, to assess the catch information and determine the structure for the next open period.

The Regional Administrator has determined that the best available information on August 14, 2001, indicated that the catch and effort data, and projections, supported the commercial fishery season modifications recommended by WDFW and ODFW. WDFW and ODFW manage the fisheries in state waters of Washington and Oregon, respectively, adjacent to the areas of the exclusive economic zone in accordance with these Federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice to fishermen of the adjustments in the area from Queets River, WA to Cape Falcon, OR effective 0001 hours l.t., August 17, 2001, was given prior to the effective date by telephone hotline number 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.

The Assistant Administrator for Fisheries, NOAA), finds for the following reasons that good cause existed for this notification to be issued without affording a prior opportunity for public comment under 5 U.S.C. 553(b)(3)(B), and delaying the effectiveness of this rule for 30 days under 5 U.S.C. 553 (d)(3), because such notification and delay would be impracticable and contrary to the public interest. As previously noted, actual notice of this action was provided to fishermen through telephone hotline and radio notification. There was insufficient time for publication of a Federal Register action and to take comments between the time the data were provided and the time this action needed to be taken in order to comply with the requirements of the annual management measures for ocean salmon fisheries (66 FR 23185, May 8, 2001) and the Pacific Coast Salmon Plan. Delay in the effectiveness of this rule would not allow fishermen appropriately controlled access to the available fish at the time they were available.

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

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