This rule has been determined to be exempt for the purpose of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB).

Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the collections of information in this rule have been approved by the OMB under control number 0563-0053 through July 31, 2001.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

The policy contained in this rule does not have any 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. Nor does this rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the states is not required.

This regulation will not have a significant economic impact on a substantial number of small entities. Additionally, the regulation does not require any more action on the part of small entities than is required on the part of large entities. The amount of work required by insurance companies will not increase because the information must already be collected under the present policy. No additional work is required as a result of this action on the part of either the insured or the insurance companies. Therefore, this action is determined to be exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605), and no Regulatory Flexibility Analysis was prepared.

This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.

This program is not subject to the provisions of Executive Order 12372 which requires intergovernmental consultation with state and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.

This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have retroactive effect. The provisions of this rule will preempt state and local laws to the extent such state and local laws are inconsistent herewith. The administrative appeal provisions published at 7 CFR part 11 must be exhausted before any action for judicial review of any determination made by FCIC may be brought.

This action is not expected to have a significant economic impact on the quality of the human environment, health, and safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.

On Monday, September 25, 2000, FCIC published a notice of proposed rulemaking in the Federal Register at 65 FR 57562-57564 to revise 7 CFR § 457.151, Forage seeding crop insurance provisions, effective for the 2002 and succeeding crop years.

Following publication of the proposed rule on September 25, 2000, the public was afforded 30 days to submit written comments and opinions. No comments were received.

FCIC has made the following changes to the Forage Seeding Crop Provisions:

1. Section 1—Added a definition for “Sales closing date.” This definition was published in a previous final rule, dated December 10, 1997, but was not included in the Forage Seeding Crop Provisions when they were published for the 1999 crop year.

2. Section 13 corrected section references from section 12 to section 13 and changed the placement of the settlement of claim example within section 13 of the crop provisions.

EVSCO Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310, has requested that FDA withdraw approval of NADA 32-984 for Cerumite (chloramphenicol, prednisolone, tetracaine, and squalane) topical suspension, and NADA 55-005 for Liquichlor with Cerumene (squalane, pyrethrins, and piperonyl butoxide) topical suspension because the products are no longer manufactured or marketed. As provided below, the animal drug regulations are amended to reflect the withdrawal of approval of these NADAs by removing 21 CFR 524.390c and 524.2140.

In a notice published elsewhere in this issue of the Federal Register , FDA is withdrawing approval of these NADAs.

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

1. The authority citation for 21 CFR part 524 continues to read as follows:

2. Section 524.390c Chloramphenicol-prednisolone-tetracaine-squalane topical suspension is removed.

3. Section 524.2140 Squalane, pyrethrins and piperonyl butoxide is removed.

Effective September 30, 1995, the Board for International Broadcasting was terminated by Public Law 103-236, 22 U.S.C. 6209e. Therefore, the Office of the Federal Register is removing BIB regulations pursuant to its authority to maintain an orderly system of codification under 44 U.S.C. 1510 and 1 CFR part 8.

Accordingly, 22 CFR is amended by removing parts 1300 through 1399 and vacating Chapter XIII.

In Title 24 of the Code of Federal Regulations, parts 700 to 1699, revised as of May 1, 2001, part 887 is removed and reserved.

As a part of the continuing efforts to reorganize the part numbering system of title 27 CFR, chapter I, ATF is removing part 200, in its entirety, and is recodifying the regulations as 27 CFR part 71. This change improves the organization of title 27 CFR.

In addition to the recodification, ATF is making a technical amendment to part 12 of title 27 CFR, chapter 1. Specifically, we are amending the reference to 27 CFR 71.41(c) to read 27 CFR 70.701(c).

The provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this final rule because there are no new or revised recordkeeping or reporting requirements.

Because no notice of proposed rulemaking is required for this rule under the Administrative Procedure Act (5 U.S.C. 553), the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. We sent a copy of this final rule to the Chief Counsel for Advocacy of the Small Business Administration in accordance with 26 U.S.C. 7805(f). No comments were received.

This final rule is not a significant regulatory action as defined in Executive Order 12866. Accordingly, this final rule is not subject to the analysis required by this Executive Order.

Because this final rule merely makes technical amendments to improve the clarity and the organization of the regulations, it is unnecessary to issue this final rule with notice and public procedure under 5 U.S.C. 553(b). Similarly, because this final rule makes no substantial changes and is merely the recodification of existing regulations, good cause is found that it is unnecessary to subject this final rule to the effective date limitation of 5 U.S.C. 553(d).

The principal author of this document is Lisa M. Gesser, Regulations Division, Bureau of Alcohol, Tobacco and Firearms.

As a part of the continuing efforts to reorganize the part numbering system of title 27 CFR, ATF is removing part 170 of title 27 CFR, in its entirety, and is recodifying the regulations as 27 CFR part 29. This change improves the organization of title 27 CFR. In addition, ATF is amending the title of the new part 29 to correspond more closely with the content of the part.

The provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this final rule because there are no new or revised recordkeeping or reporting requirements.

Because no notice of proposed rulemaking is required for this rule under the Administrative Procedures Act (5 U.S.C. 553), the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. We sent a copy of this final rule to the Chief Counsel for Advocacy of the Small Business Administration in accordance with 26 U.S.C. 7805(f). No comments were received.

It is hereby certified that this final rule is not a significant regulatory action as defined in Executive Order 12866. Accordingly, this final rule is not subject to the analysis required by this Executive Order.

Because this final rule merely makes technical amendments to improve the clarity and organization of the regulations, it is unnecessary to issue this final rule with notice and public procedure under 5 U.S.C. 553(b). Similarly, because this final rule makes no substantial changes and is merely the recodification of existing regulations, good cause is found that it is unnecessary to subject this final rule to the effective date limitation of 5 U.S.C. 553(d).

The principal author of this document is Lisa M. Gesser, Regulations Division, Bureau of Alcohol, Tobacco and Firearms.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022).

Accordingly, this amendment (1) adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during September 2001, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during September 2001, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during September 2001.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 6.30 percent for the first 20 years following the valuation date and 6.25 percent thereafter. These interest assumptions represent a decrease (from those in effect for August 2001) of 0.10 percent for the first 20 years following the valuation date and are otherwise unchanged.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 4.50 percent for the period during which a benefit is in pay status, and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent a decrease (from those in effect for August 2001) of 0.25 percent for the period during which a benefit is in pay status and are otherwise unchanged.

For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect, as accurately as possible, current market conditions.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during September 2001, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *” and “rules and regulations consistent with regulations issued by the Secretary” pursuant to the Act. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Arkansas program on November 21, 1980. You can find background information on the Arkansas program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the November 21, 1980, Federal Register (45 FR 77003). You can find later actions on the Arkansas program at 30 CFR 904.10, 904.12, 904.15, and 904.16.

By letter dated March 1, 2001 (Administrative Record No. AR-567.04), Arkansas sent us an amendment to its program under SMCRA and the Federal regulations at 30 CFR 732.17(b). Arkansas sent the amendment in response to our letter dated August 23, 2000 (Administrative Record No. AR-567), that we sent to Arkansas under 30 CFR 732.17(c). The amendment also includes changes made at Arkansas' own initiative. Arkansas proposed to amend the Arkansas Surface Coal Mining and Reclamation Code (ASCMRC). We announced receipt of the amendment in the April 6, 2001, Federal Register (66 FR 18216). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. The public comment period closed on May 7, 2001. We did not receive any comments. Because no one requested a public hearing or meeting, we did not hold one.

During our review of the amendment, we identified concerns about the definitions; submission and processing of requests for valid existing rights determinations; interpretative rule related to subsidence due to underground coal mining in areas designated by Act of Congress; public notices of filing of permit applications; and legislative public hearings. We notified Arkansas of these concerns by letter dated April 11, 2001, (Administrative Record No. AR-567.06).

By letter dated April 19, 2001 (Administrative Record No. AR-567.08), Arkansas sent us revisions to its program amendment. Based upon Arkansas' revisions to its amendment, we reopened the public comment period in the May 10, 2001, Federal Register (66 FR 23868). The public comment period closed on May 25, 2001. We did not receive any comments.

Following, under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are the OSM Director's findings concerning the amendment to the Arkansas program.

Any revisions that we do not discuss below are about minor wording changes, or revised cross-references and paragraph notations to reflect organizational changes resulting from this amendment

The State regulations listed in the table contain language that is the same as or similar to the corresponding sections of the Federal regulations. Differences between the State regulations and the Federal regulations are minor.

Because the above State regulations have the same meaning as the corresponding Federal regulations, we find that they are no less effective than the Federal regulations.

Due to an apparent error, Arkansas' regulations contain two different definitions for “public buildings;” one in section 761.5 Definitions, the other in section 761.15 Public buildings. This occurred when the State was revising the definition of “public buildings” and inadvertently inserted a new section (section 761.15 Public buildings) instead of modifying the existing definition of “public buildings” at section 761.5 Definitions. Arkansas proposed to eliminate this redundancy and to avoid confusion by removing section 761.15 “Public buildings,” and by replacing the definition of “public buildings” in section 761.5 with the definition of “public buildings” that was found in section 761.15. We are approving this revision because the revised definition of “public buildings” in section 761.5 is language that we previously approved at old section 761.15 and because the revision will eliminate any redundancy and confusion that may have been caused by the two definitions of “public buildings” that previously existed in the State's regulations.

Arkansas proposed to redesignate section 762.14 as new section 762.15. We are approving this revision because it only changes the section number of the regulation and will not alter the approved language in the section.

Arkansas proposed to revise Section 764.15(a)(7) by changing the name of the hearing from an “informal conference” to that of a “legislative public hearing.” We are approving this revision because it only changes the name of the hearing and does not change the meaning or the intent of the regulation.

Arkansas proposed to revise Section 786.14(c) by replacing the reference citation to 761.12(d) with a reference citation to newly added section 761.14(c). Arkansas also proposed to revise this regulation to reflect that the legislative public hearings may be used to meet the requirement of a public hearing if one is requested under section 761.14(c) where the applicant proposes to relocate or close a public road or to conduct surface coal mining operations within 100 feet, measured horizontally, of the outside right-of-way line of a public road. The revised section reads as follows:

We are approving the revision that replaces the reference citation to 761.12(d) with a reference citation to newly added section 761.14(c) because the provisions contained in old section 761.12(d) remain unchanged and have been reorganized and are now recodified in newly added section 761.14(c). We are also approving the revision to section 786.14 that reflects that the public hearings, if requested, may be used to meet the public hearing requirement under section 761.14(c) where the applicant proposes to relocate or close a public road or to conduct surface coal mining operations within 100 feet, measured horizontally, of the outside right-of-way line of a public road. We are approving this revision because it is consistent with the Federal regulations at 30 CFR 761.14(c) and (c)(1)-(c)(2) that require the regulatory authority or a public road authority that it designates to determine that the interests of the public and affected landowners will be protected. These Federal regulations also require that the regulatory authority must, among other things, provide opportunity to request a public hearing in the locality of the proposed operation before making this determination.

Arkansas proposed to delete sections 786.19(d)(4) and (d)(5) and to redesignate sections 786.19(d)(6) through (d)(8) as sections 786.19(d)(4) through (d)(6). We are approving the deletion of sections 786.19(d)(4) and (d)(5) because the provisions contained in these sections are contained in revised section 786.19(d)(1) via a reference to section 761.11. We are also approving the redesignation of sections 786.19(d)(6) through (d)(8) as sections 786.19(d)(4) through (d)(6) because it will not render the Arkansas regulations less effective than the Federal regulations at 30 CFR 773.15(c).

In a letter dated April 2, 1999, Arkansas notified us that the “Arkansas Department of Pollution Control and Ecology” had its name changed to the “Arkansas Department of Environmental Quality,” effective March 31, 1999. Along with the name change, the general powers and responsibilities previously assigned to the “Arkansas Department of Pollution Control and Ecology” were transferred to the “Arkansas Department of Environmental Quality.” In a letter dated June 9, 1999, we notified the State that it must amend its approved program to reflect these changes. Because of the administrative nature of the change, we requested that Arkansas change the references to the “Arkansas Department of Pollution Control and Ecology” to references to the “Arkansas Department of Environmental Quality” in its regulations and/or statutes the next time the State proposed to amend its approved program. Arkansas responded in a letter dated June 23, 1999, that the State had already replaced all references to the “Arkansas Department of Pollution Control and Ecology” with references to the “Arkansas Department of Environmental Quality” in its regulations. Arkansas further responded that on April 6, 1999, the Arkansas Legislature passed Act 1164 approving the agency's name change to the “Arkansas Department of Environmental Quality” and revising all Arkansas statutes to reflect the name change.

Also, in its June 23, 1999, letter Arkansas advised us that the “legislative version” of the Arkansas Surface Coal Mining and Reclamation Act (Act 134 of 1979), as amended by Act 647 of 1979 has not existed, per se, since the effective date of Act 267 of 1987, which created and adopted the Arkansas Code. Effective December 31, 1987, Act 267 codified all existing Arkansas statutes into the Arkansas Code Annotated (ACA) without changing the substance or meaning of any provision of the statutes. All the provisions of the Arkansas Surface Coal Mining and Reclamation Act are codified at ACA Title 15, Chapter 58, Subchapters 1 through 5.

We are approving the name change of the Arkansas regulatory authority from the “Arkansas Department of Pollution Control and Ecology” to the “Arkansas Department of Environmental Quality.” We are also approving the recodification of the Arkansas statutes from the “legislative version” to the “annotated version.” We find that the changes are administrative in nature and do not render the Arkansas regulations less effective than the Federal regulations. Nor do the changes render the Arkansas statutes less stringent than the Federal statutes.

On March 14 and May 3, 2001, under section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Arkansas program (Administrative Record Nos. AR-567.05 and AR-567.09, respectively). We did not receive any comments.

Under 30 CFR 732.17(h)(11)(ii), we are required to obtain the written concurrence of the EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Arkansas proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask the EPA for its concurrence.

Under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from the EPA (Administrative Record Nos. AR-567.05 and AR-567.09). The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On March 14 and May 3, 2001, we requested comments on Arkansas' amendment (Administrative Record Nos. AR-567.05 and AR-567.09, respectively), but neither entity responded to our request.

We asked for public comments on the amendment, but did not receive any.

Based on the above findings, we approve the amendment as sent to us by Arkansas on March 1, 2001, and as revised on April 19, 2001. We approve the regulations that Arkansas proposed with the provision that they be published in identical form to the regulations sent to and reviewed by OSM and the public.

To implement this decision, we are amending the Federal regulations at 30 CFR Part 904, which codifies decisions about the Arkansas program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making the regulations effective immediately will expedite that process and will encourage Arkansas to bring its program into conformity with the Federal standards. SMCRA requires consistency of State and Federal standards.

This rule is exempt from review by the Office of Management and Budget under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations.

This rule does not have federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary under SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed State regulatory program provision does not constitute a major Federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined 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. ). The State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *” and “rules and regulations consistent with regulations issued by the Secretary” pursuant to the Act. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Indiana program on July 29, 1982. You can find background information on the Indiana program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the July 26, 1982, Federal Register (47 FR 32107). You can find later actions on the Indiana program at 30 CFR 914.10, 914.15, 914.16, and 914.17.

By letter dated May 14, 1998 (Administrative Record No. IND-1606), Indiana submitted a proposed amendment to OSM in accordance with SMCRA. The proposed amendment concerned revisions of and additions to the Indiana Code (IC) made by House Enrolled Act (HEA) No. 1074. Indiana intended to revise its program to incorporate the additional flexibility afforded by SMCRA and to provide the guidelines for permit revisions, including incidental boundary revisions. We announced receipt of the proposed amendment in the May 29, 1998, Federal Register (63 FR 29365), and invited public comment on its adequacy. The public comment period for the amendment closed June 29, 1998. During our review of the proposed amendment, we identified concerns relating to the proposed amendment. We notified Indiana of these concerns by letter dated September 15, 1998 (Administrative Record No. IND-1621). By letter dated December 21, 1998 (Administrative Record No. IND-1627), Indiana responded to our concerns by submitting additional explanatory information. Because Indiana did not make any substantive revisions to the amendment, we did not reopen the public comment period. On March 16, 1999, we approved Indiana's proposed amendment, with three exceptions (64 FR 12890). Specifically, we did not approve the amendment at IC 14-34-5-7(a) concerning guidance for permit revisions; the amendment at IC 14-34-5-8.2(4) concerning postmining land use changes; and the amendment at IC 14-34-5-8.4(c)(2)(K) concerning minor field revisions for temporary cessation of mining. On May 26, 1999, at Indiana's request, we provided clarification of our decision on Indiana's amendment (64 FR 28362).

On May 14, 1999, the Indiana Coal Council (ICC) filed a complaint in the United States District Court, Southern District of Indiana, to challenge our decision not to approve the proposed Indiana program amendments at IC 14-34-5-7(a) and IC 14-34-5-8.2(4). Indiana Coal Council v. Babbitt, No. IP 99-0705-C-M/S, (S. D. Ind.). On September 25, 2000, the Court issued its decision on the ICC's complaint. The Court found that, in the case of IC 14-34-5-7(a) concerning guidance for permit revisions, OSM was not arbitrary and capricious in not approving the amendment. Therefore, the Court upheld our decision. However, in the case of IC 14-34-5-8.2(4) concerning postmining land use changes, the Court found that our decision was arbitrary and capricious, and remanded the matter to OSM for “further consideration.” In accordance with the Court's ruling, we opened the public comment period for section IC 14-34-5-8.2(4) of Indiana's proposed amendment submitted on May 14, 1998, in the January 11, 2001, Federal Register (66 FR 2374). In the same document, we provided an opportunity for a public hearing or meeting on the adequacy of the amendment. The public comment period closed on February 12, 2001. We received comments from two industry groups and one Federal agency. However, because no one requested a public hearing or meeting, we did not hold one.

Following, under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are the Director of OSM's findings concerning the proposed amendment to the Indiana program.

Indiana's proposed amendment at IC 14-34-5-8.2(4) provides that a proposed permit revision is nonsignificant, and therefore not subject to the notice and hearing requirements of IC 14-34, if it is a postmining land use change other than a change described in IC 14-34-5-8.1(8). IC 14-34-5-8.1(8) provides that a proposed permit revision is significant if a postmining land use will be changed to a residential land use, a commercial or industrial land use, a recreational land use, or developed water resources meeting MSHA requirements for a significant impoundment.

In the U.S. District Court case, the ICC argued that our original decision not to approve IC 14-34-5-8.2(4) was arbitrary and capricious for two reasons: (1) Because we offered conflicting reasons for our decision; and (2) because we gave no reason for distinguishing Indiana's definition of a significant permit revision from the nearly identical program we approved for Tennessee.

In evaluating whether we offered conflicting reasons for our decision, the Court stated that it did appear that we had changed our position as to whether the Director of the Indiana Department of Natural Resources (IDNR) retained discretion to determine if a proposed permit revision concerning a postmining land use change is significant. But, the Court stated that our ultimate conclusion—that the amendment was inconsistent with the Act because it would allow for certain significant changes to be made without notice and hearing requirements—never changed. Thus, the Court found that we had not been arbitrary and capricious just because we changed our position as it concerned the INDR Director's discretion.

However, the Court found that we did not distinguish Indiana's definition of a significant permit revision from the definition in the Tennessee program. The Court concluded that, by adding the provision at IC 14-34-5-8.2(4), Indiana made its program essentially the same as the Tennessee program by providing that if a change did not fall under the definition of significant, it was nonsignificant. Specifically, the Court stated that “it appears that the Tennessee and Indiana statutes would dictate the same results with respect to classifying certain postmining land use changes as either significant or nonsignificant.” In the case of the example we used in our March 16, 1999, decision—a change from cropland to forest—the Court states, “[a]ssuming such change would be significant, it is not one of the changes listed in Tennessee's approved definition of ‘significant.’ Thus, by default, it would be ‘nonsignificant’ under the Tennessee program”—just as it would under the Indiana program. Indiana Coal Council v. Babbit, No IP 99-0705-C-M/S, slip op. at 14, (S. D. Ind., Sept. 25, 2000). Thus, it appeared to the Court that the existing Tennessee program and the proposed Indiana amendment would dictate the same results with respect to classifying certain postmining land use changes as significant or nonsignificant. The Court stated that we provided no explanation for not approving Indiana's statute when we had a regulation under the Tennessee program that was nearly identical. Because it appeared that we departed from our prior rulings and failed to explain why, the Court found that our ruling was arbitrary and capricious.

The existing Tennessee program and the proposed Indiana amendment would not dictate the same results with respect to classifying certain postmining land use changes as significant or nonsignificant. Under the Tennessee program, the Director of OSM retains discretion to determine whether land use changes other than those listed in 30 CFR 942.774(c)(8) are significant or nonsignificant permit revisions. A postmining land use is not, by default, a nonsignificant permit revision just because it is not one of the changes listed in Tennessee's approved definition of “significant.” Instead, the Director of OSM makes that determination on a case-by case basis. We have always maintained that this discretion is a necessary part of the Tennessee program. In the December 5, 1988, preamble to 30 CFR 942.774, we state, “OSMRE believes that some flexibility in language is necessary to allow for contingencies or applications that are not possible to foresee” (53 FR 49104). Thus, in the case of the example we cited in our March 16, 1999, decision—a change from cropland to forest—the change may be processed as either a significant or nonsignificant permit revision depending upon the Director of OSM's determination.

Indiana's provision at IC 14-34-5-8.2(4), on the other hand, eliminates the IDNR Director's discretion to determine whether a postmining land use change would classify as significant. Under IC 14-34-5-8.2(4), all postmining land use changes other than those listed at IC 14-34-5-8.2(4) have to be nonsignificant. In the case of the example we cited in our March 16, 1999, decision—a change from cropland to forest—the change must be considered nonsignificant. Indiana's proposed amendment would not allow for any other determination. Clearly, the two programs are different. For these reasons, we conclude that our decision not to approve the Indiana amendment at IC 14-34-5-8.2(4) was not a departure from our prior ruling in the Tennessee program. Instead, our decision was consistent with our longstanding position that some flexibility in language is necessary to allow for contingencies or applications of the rule that were not covered by the provision at 30 CFR 942.774(c). IC 14-34-5-8.2(4) would eliminate such flexibility.

Given the differences between the Indiana proposed amendment and the approved Tennessee program, and taking into account all the comments we received on this amendment, we find that our original decision not to approve IC 14-34-5-8.2(4) was correct in its result. We agree with the Court that our original decision not to approve required additional consideration and explanation of our rationale. Based on our additional consideration and explanation, we find IC 14-34-5-8.2(4) conflicts with section 511(a)(2) of SMCRA, which requires notice and hearing requirements for any significant alterations in a reclamation plan. IC 14-34-5-8.2(4) would allow many changes that could produce significant alterations in a reclamation plan without notice and hearing requirements. For example, it would allow a change from cropland to forest without notice and hearing requirements. Depending on the circumstances, this change could be a significant permit revision. The IDNR Director must be free to determine if such a change would constitute a significant permit revision so as to assure that appropriate procedures are provided for the public's participation in the revision of reclamation plans as required under section 102(i) of SMCRA. Indiana's proposed amendment at IC 14-34-5-8.2(4) does not provide for such a determination.

In its December 21, 1998, letter, Indiana stated that it interprets this section to mean that the Director of the State regulatory authority retains discretion under IC 14-34-5-8.2(5) to determine whether land use changes other than those listed in IC 14-34-5-8.1(8) could be significant revisions. Indiana further stated that all permit revision decisions are appealable under the Indiana Administrative Orders and Procedures Act.

We agree that the IDNR Director retains discretion as to whether a permit revision is significant or nonsignificant. However, in the instance of postmining land use changes, it is clear on its face that the provision at IC 14-34-5-8.2(4) removes such discretion. Thus, as explained above, the statute is inconsistent with, and less stringent than, section 511(a)(2) of SMCRA, which requires notice and hearing requirements for any significant alterations in a reclamation plan. The fact that all permit revision decisions are appealable under the Indiana Administrative Orders and Procedures Act does not justify the inclusion of a provision in this section that is inconsistent with, and less stringent than, section 511(a)(2) of SMCRA. Therefore, we do not approve IC 14-34-5-8.2(4).

On January 5, 2001, under section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Indiana program (Administrative Record No. IND-1709). The Fish and Wildlife Service (FWS) responded on January 16, 2001 (Administrative Record No. IND-1706). The FWS states that in its previous comments dated June 19, 1998 (Administrative Record No. IND-1615), it had expressed concern that the amendment would result in reduced opportunities for the FWS to review land use changes that might adversely affect fish and wildlife resources. However, the amendment to IC 14-34-5-8.1(5), which provides that permit revisions that may result in an adverse impact on fish, wildlife, and related environmental values beyond that previously considered must be addressed as significant permit revisions, appears to have satisfied its concern, assuming that “permit revisions” include postmining land use changes. The FWS states that the amendment to IC 14-35-5-8.2(4) would allow changes from forest or fish and wildlife land to a category other than the four specified categories to be processed as nonsignificant permit revisions without notice and hearing requirements. The FWS contends that such a change could be in conflict with 8.1(5) because it may allow a postmining land use change that may result in an adverse impact on fish, wildlife and related environmental values beyond that previously considered to be addressed as a nonsignificant permit revision. The FWS states that this incompatibility should be resolved prior to approval. The FWS recommends that 8.2(4) be modified to include 8.1(5) as well as 8.1(8).

We agree that IC 14-34-5-8.2(4) may allow a postmining land use change that may result in an adverse impact on fish, wildlife and related environmental values beyond that previously considered to be addressed as a nonsignificant permit revision. For that reason, we find that the provision conflicts with section 511(a)(2) of SMCRA, which requires notice and hearing requirements for any significant alterations in a reclamation plan, and we are therefore not approving the provision. Please refer to III. Director's Findings. Because we are not approving IC 14-34-5-8.2(4), there is no need to modify it.

Under 30 CFR 732.17(h)(11)(ii), we are required to obtain the written concurrence of the EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Indiana proposed to make in this amendment pertain to such air or water quality standards. Therefore, we did not ask the EPA for its concurrence.

Under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from the EPA (Administrative Record No. IND-1709). The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP for amendments that may have an effect on historic properties. On January 5, 2001, we requested comments from the SHPO and ACHP on Indiana's amendment (Administrative Record No. IND-1706), but neither responded to our request.

OSM requested public comments on the proposed amendment. We received comments from two groups representing the coal industry. By letter dated February 5, 2001, the ICC submitted comments on the proposed amendment (Administrative Record No. IND-1707). Also, by letter dated February 12, 2001, the National Mining Association (NMA) submitted comments on the proposed amendment (Administrative Record No. IND-1708). Both organizations provided comments supporting the amendment. For ease of discussion, the comments have been organized by topic and are discussed below.

In addition, in its letter dated February 5, 2001, the ICC informed us that it had requested information from the Knoxville OSM Field Office under the Freedom of Information Act. The ICC stated that if it did not receive the information it requested, “the ICC will be requesting an extension” to the public comment period for this amendment. Although we did not receive a request for an extension, the ICC submitted additional comments on the proposed amendment by a letter dated February 28, 2001 (Administrative Record No. IND-1710). Given the level of interest the ICC has in this proposed amendment, we have incorporated the ICC additional comments into the discussion below.

Both the ICC and the NMA contend that IC 14-34-5-8.2(4) was added to HEA 1074 at OSM's suggestion. As support for this contention, both organizations refer to a letter dated February 20, 1998, that we sent Indiana, providing preliminary comments on the legislative bill that was later enacted as HEA 1074. The ICC points out that, as originally proposed, HEA 1074 contained the provision at IC 14-34-5-8.1 classifying certain postmining land uses as significant permit revisions and an additional provision in IC 14-34-5-8.2 stating that a revision is nonsignificant if it does not involve a significant change in land use. The ICC states that in our preliminary comments:

The ICC maintains that Indiana followed our suggestion and inserted a provision at IC 14-34-5-8.2(4) which classified as nonsignificant revisions all postmining land use changes not defined as significant revisions at IC 14-34-5-8.1(8). The NMA asserts that “[a]gencies should not recommend a course of action and then penalize IDNR for following their advice.”

Response: The ICC has taken the comments in our February 20, 1998, letter out of context. In the letter, we offered specific comments on section 8.2(a)(5)(B), which provided that a revision was nonsignificant if it did not involve a significant change in land use. We expressed concern that the provision at 8.2(a)(5)(B) conflicted with the provision in section 8.1(8) which provided that land use changes to residential, commercial or industrial, recreational, or developed water resources are significant revisions. Specifically, we stated that there appear to be two standards for determining whether a post mining land use change is significant. We further stated that the two standards may result in different determinations, depending on which section of the statute is used.

We then offered a general comment concerning permit revisions as a whole. Specifically, we stated:

Thus, we were not talking specifically about postmining land use changes when we commented, “[g]enerally, then if a revision doesn't meet the standards specified in the program, it is by default that other type of revision.” We were talking about permit revisions as a whole. Further, it is erroneous to assume, based on this comment, that revisions that do not meet the standards specified in a regulatory program are automatically the other type of revision because the comment was qualified by the word “generally.” The word “generally” clearly leaves the door open for discretion in determining if a revision that does not meet the standards specified in a regulatory program is significant or nonsignificant, just as the Tennessee program does. Finally, the only suggestion in the entire paragraph was that Indiana provide guidelines for only one type of permit revision. That way, Indiana would have guidelines for making permit revision determinations, but those guidelines would not eliminate Indiana's ability to determine, on a case-by-case basis, whether a permit revision was a significant or nonsignificant revision. Indiana did not adopt this suggestion. Therefore, the NMA's concern that we penalized IDNR for following our advice is unfounded.

Both the ICC and the NMA contend that we first attempted to justify our decision not to approve IC 14-34-5-8.2(4) in the March 16, 1999, final rule (64 FR 12890) by claiming that all postmining land use changes should be treated as significant permit revisions. The ICC implies that we made this claim when we stated that “changes in postmining land use are the kind of issue that the public should have an opportunity to comment on.” The NMA asserts that such a claim is contradicted by the legislative history of SMCRA. The NMA states that Congress considered but rejected specific language that would have required a permit revision prior to modification of proposed future land use. The NMA argues that this legislative history demonstrates that not all modifications of future land uses must invoke notice and hearing requirements “as alleged by OSM.” It may even imply that some modifications of the proposed future land use do not require a permit revision at all.

Response: We disagree that we attempted to justify our decision not to approve IC 14-34-5-8.2(4) by claiming that all postmining land use changes should be treated as significant permit revisions. We did not approve IC 14-34-5-8.2(4) because it was inconsistent with section 511(a)(2) of SMCRA, which requires public notice and hearing procedures for any significant alteration in a reclamation plan. Please refer to III. Director's Findings 6. of our March 16, 1999, final rule in which we stated:

Further, we do not maintain that all postmining land use changes should be treated as significant permit revisions, and we disagree with the implication that we made such a claim with our statement concerning opportunities for public comments. The central purpose of our May 26, 1999, final rule clarification was to make it clear that we in no way intended to indicate that all land use changes other than those listed at IC 14-34-5-8.1(8) must be considered significant revisions. Thus, we would agree with the NMA's assertion that the legislative history of SMCRA demonstrates that not all modifications of future land uses must invoke notice and hearing requirements. However, we do not agree that the legislative history implies that some modifications of the proposed future land use do not require a permit revision at all. The ICC made this basic contention in its comments on Indiana's proposed program amendment at IC 14-34-5-7(a) when it argued that nothing in SMCRA specifically states that all mining or reclamation changes are revisions subject to regulatory authority approval (Administrative Record No. IND-1617). However, as we explained in our decision not to approve that proposed program amendment, we have established that all revisions must be incorporated into the permit since they are changes to that document (64 FR 12894). As stated above, the ICC challenged our decision not to approve IC 14-34-5-7(a) and the Court upheld our decision. Indiana Coal Council v. Babbitt , No IP 99-0705-C-M/S (S. D. Ind, Sept. 25, 2000).

The ICC states that we changed the reasoning behind our decision not to approve IC 14-34-5-8.2(4) in the May 26, 1999, final rule clarification (64 FR 28362) by claiming that the problem with the Indiana program amendment was that it deprived IDNR of discretion to require that post mining land use changes be treated as significant permit revisions. The ICC points out that the IDNR had explained that it interpreted IC 14-34-5-8.2 to mean that its Director would retain discretion under IC 14-34-5-8.2(5) to determine that land use changes other than those listed in IC 14-34-5-8.1(8) could be significant permit revisions. The NMA asserts that this interpretation by the IDNR Director refutes our argument that the proposed amendment would remove the IDNR Director's discretion to determine whether post mining land use changes other than the ones listed at IC 14-34-5-8.1(8) are significant. Both the ICC and the NMA further assert that we agreed with the IDNR's interpretation in the March 16, 1999, final decision. The ICC states that nothing in either of our prior decisions explains how we can reconcile our statement that we agree with the IDNR's interpretation with our “clarified” position that section 14-34-5-8.2 deprives the IDNR of discretion.

Response: In our May 26, 1999, final rule clarification (64 FR 28362), we specifically stated that we were supplementing our previous findings—not replacing them. Furthermore, the Court specifically stated that we never changed our ultimate conclusion that IC 14-34-5-8.2(4) was inconsistent with section 511(a)(2) of SMCRA. Therefore, it is incorrect to assert that we changed our original decision. Please refer to III. Director's Findings 6. of our March 16, 1999, final rule in which we stated:

We published the May 26, 1999, final rule clarification at the request of a May 12, 1999, letter we received from the IDNR. In that letter, the IDNR asked us to “provide clarification of the Federal Register language which disapproved portions of the program amendment pursuant to those issues which were subject to our May 10, 1999 discussions.”

On May 10, 1999, we held a telephone conference with representatives from both the IDNR and the ICC to discuss the ICC's concerns with the portions of the Indiana's May 29, 1998, amendment that we did not approve. During that meeting, the ICC argued that our decision not to approve IC 14-34-5-8.2(4) eliminated the IDNR's discretion to determine whether postmining land use changes are nonsignificant permit revisions because we had declared that all postmining land use changes should be treated as significant permit revisions.

In our final rule clarification, we stated that it was not our intent to indicate that all other land use changes must be considered a significant revision or to alter OSM's position as reflected in other regulatory actions relating to significant permit revisions, such as those for the Federal program in Tennessee (see the response to comments under 3. above).

We further went on to explain that we felt it is essential for Indiana to continue to have the discretion to determine, on a case-by-case basis, that land use changes other than those listed in section IC 14-34-5-8.1(8) may constitute a significant revision. Thus, one of the purposes of our clarification was to explain that, contrary to the ICC's assertion, our decision not to approve IC 14-34-5-8.2(4) did not eliminate IDNR's discretion to determine whether postmining land use changes are nonsignificant permit revisions. Instead, it was “clear on its face that the proposed change would remove such discretion.” Our decision not to approve IC 14-34-5-8.2(4) preserved IDNR's discretion. Therefore, we agreed with the IDNR when it claimed that its Director retained discretion as to whether a change is significant or nonsignificant. Our decision not to approve IC 14-34-5-8.2(4) guaranteed that.

The NMA contends that our objections to Indiana's proposed amendment are particularly unusual because the current proposal at issue was copied almost verbatim from part of the Federal SMCRA program promulgated and approved by OSM on behalf of the State of Tennessee. Further, the NMA argues that the language of OSM's Federal program in Tennessee at 30 CFR 942.774 implies that items not listed as “significant” are not significant. The NMA states, “the Federal program run by OSM in Tennessee expressly considers changes to the reclamation plan of the type being cited by the agency as objectionable (cropland to forest) to be “insignificant” that do not require notice and hearings.”

Response: The Tennessee SMCRA program provisions concerning permit revisions at 30 CFR 942.774 do not contain a counterpart to “the current proposal at issue”—IC 14-34-5-8.2(4). Further, the language at 30 CFR 942.774 does not imply that items not listed as “significant” are not significant. Nor does it expressly consider changes to the reclamation plan of the type being cited by the agency as objectionable (cropland to forest) to be “insignificant.” As stated in III. Director's Findings, in the preamble to the final rule approving 30 CFR 942.774, we explain that the language at 30 CFR 942.774 was intentionally written in such a way “to allow for contingencies or applications of the rule that are not possible to foresee” (53 FR 49104). Thus, we have always maintained that revisions other that those found at 30 CFR 942.774 could be considered significant.

The ICC argues that IC 14-34-5-8.1 is similar to the corresponding provision of the Federal SMCRA program adopted by OSM for the state of Tennessee. The ICC contends that IC 14-34-5-8.1 is virtually identical to 30 CFR 942.744(c)(8). The only way that Indiana's program differs from Tennessee's program is that Indiana's amendment added a new section 14-34-5-8.2(4) which provides that postmining land use changes other than those enumerated in section 14-34-5-8.1 are classified as nonsignificant revisions. The Tennessee program has no provision defining nonsignificant revisions.

Response: We agree that IC 14-34-5-8.1 is virtually identical to 30 CFR 942.744(c)(8) and we acknowledged this in our March 16, 1999, final rule when we approved IC 14-34-5-8.1 (64 FR 12892). However, we do not agree that the only way that Indiana's program differs from Tennessee's program is that Indiana's amendment added a new section 14-34-5-8.2(4). For example, the Tennessee program does not have a counterpart to any of the provisions at IC 14-34-5-8.2 concerning nonsignificant permit revisions. Still, even if Indiana's program were similar to the Tennessee program, Indiana's program is not entitled to instant approval. We still must review Indiana's program to determine if it is as stringent as the Federal program. We have determined it is not. Please refer to III. Director's Findings.

The ICC questions whether we have in fact ever exercised our discretion under the Federal Tennessee program to require that a postmining land use change other than the ones specified in 30 CFR 942.774(c)(8) be treated as a significant permit revision. On January 31, 2001, under the Freedom of Information Act, the ICC submitted a request to the OSM Knoxville Field Office for information concerning “any correspondence, internal memoranda or notes, or permit decision documents reflecting any decision by OSM to require any permit revision to a surface coal mining and reclamation operations permit issued under the federal program for the State of Tennessee * * * to be treated as a significant permit revision.” On February 20, 2001, the Knoxville Field Office responded to the ICC's request by providing information about one permit revision which involved a change from non-commercial forest to an industrial postmining land use. Thus, the ICC states that OSM, as the regulatory authority under the Tennessee Federal program, has never required any change in postmining land use to be treated as a significant permit revision other than a change in one of the categories specifically listed in 30 CFR 9472.774(c)(8). Furthermore, the ICC argues that, to the extent that we may have retained discretion under the Tennessee program regulations to treat other categories of postmining land use changes as significant permit revisions, it does not appear that we have ever had occasion to exercise that discretion. In light of this experience under the Tennessee program, the ICC believes that we should reevaluate our prior position that Indiana must retain such discretion in order for its program to be no less effective than the federal regulations. The ICC contends that if postmining land use changes other than those specified at 30 CFR 942.774(c)(8) are not treated as significant permit revisions in practice in Tennessee, the Indiana program would be no less effective than OSM's rules regardless if the IDNR has discretion to so treat them. The NMA argues that the language of our Federal program in Tennessee does not provide for discretion by the Director of OSM, and that we have not provided any examples of discretion being exercised in Tennessee.

Response: As stated above in the response to comment 4. and in III. Director's Findings, the language of our Federal program in Tennessee does provide for discretion by the Director of OSM, as it was written in such a way “to allow for contingencies or applications of the rule that are not possible to foresee” (53 FR 49104). In fact, under the Tennessee SMCRA program, every decision of the Director of OSM on a land use change revision other than those listed at 30 CFR 942.774(c)(8) is discretionary.

As for whether we have ever required a postmining land use change other than the ones specified in 30 CFR 942.774(c)(8) to be treated as a significant permit revision, the answer is no. However, this does not mean that we have never exercised our discretion under the Federal Tennessee program. In fact, we maintain that every decision the Director of OSM has made under the Federal Tennessee program relating to postmining land use changes not listed at 30 CFR 942.774(c)(8) is an exercise of discretion. The Director of OSM has merely determined that the postmining land use changes to date are nonsignificant. Under Indiana's proposed amendment, the IDNR Director would not be able to make such a determination. As stated above in III. Director's Findings, elimination of the IDNR Director's discretion in the Indiana program would render Indiana's program less effective than the Federal program and conflict with section 511(a)(2) of SMCRA. Therefore, we are not approving the provision at IC 14-34-5-8.2(4).

Finally, the ICC argues that eliminating INDR discretion will not affect the way in which Indiana executes its program. If that is true, then preserving INDR discretion as we have by not approving IC 14-34-5-8.2(4) will also not affect the way in which Indiana executes its program. Therefore, the ICC's concerns are unwarranted.

Both the ICC and the NMA contend that, in practice, changes in post mining land uses of the type being proposed have not been considered significant permit revisions under IDNR's regulations since 1989. The ICC indicates this is because of an IDNR's Hearings Division determination in Albrecht v. DNR, Cause #88-294R (June 13, 1989) that postmining land uses were not significant permit revisions under IDNR's regulations. The NMA states that we have not offered any evidence that refutes this fact. Further, the ICC and the NMA point out that we have not noted any problems with the IDNR's practice over the past 12 years.

Response: As stated above, if eliminating INDR discretion will not affect the way in which Indiana executes its program, then preserving INDR discretion as we have by not approving IC 14-34-5-8.2(4) will also not affect the way in which Indiana executes its program. Therefore, the ICC's and NMA's concerns are unwarranted.

The ICC contend there is no need for OSM to strain for reasons to not approve IC 14-34-5-8.2(4) because whether postmining land use changes are treated as significant permit revisions or not, existing provisions of the approved Indiana program already insure that postmining land use changes cannot be approved without consultation with the landowner or appropriate land management agency. The ICC suggests that it is the landowner or land management agency, not the public at large, which is most likely to be interested in proposed postmining land use changes. The NMA points out that OSM has not identified any public comments from the last round of notice and comments objecting to IDNR's proposed amendment.

Response: We disagree with the contention that the public at large is not interested in proposed postmining land use changes. In fact, such a claim is in direct conflict with section 102(i) of SMCRA, which states that SMRCA was designed to assure that appropriate procedures are provided for the public participation in the revision of reclamation plans. As we stated in III. Director's Findings, we believe it is essential that regulatory authorities retain discretion to determine which revisions qualify as significant permit revisions so that the purposes of section 102(i) can be met. Therefore, we are not approving IC 14-34-5-8.2(4).

The NMA also argues that Indiana's proposed language is consistent with SMCRA section 511(a)(2) because neither SMCRA nor OSM regulations define “significant.” Therefore, there can be no direct showing that the proposed amendment is “less stringent than” the requirement in section 511(a)(2) of SMCRA. The NMA argues that since there is no definition of “significant” in SMCRA or OSM's regulations, it is the State regulatory authority that should determine what constitutes “significant” revisions to the reclamation plan. The NMA argues that this position is supported by the fact that SMCRA and OSM's implementing regulations clearly provide that: (1) States are supposed to enjoy “exclusive” jurisdiction over the regulation of surface coal mining and reclamation operations (30 USC 1253(a)), and (2) nonsignificant permit revisions are subject only to the review procedures established under the State or Federal programs (48 FR 44377). According to the NMA, then, it is appropriate for OSM to defer to the IDNR's reasonable definition of “significant.”

Response: Indiana defined and provided eight specific examples of significant permit revisions at IC 14-34-5-8.1, and we approved the provisions on March 16, 1999 (64 FR 12890). Therefore, we have accepted the IDNR's reasonable definition of significant permit revisions. Furthermore, Indiana's definition of significant permit revisions is not all inclusive. We recognized this when we stated in our approval that “this list cannot be considered all inclusive, as there are many other changes not listed at IC 14-34-5-8.1 that would be considered significant permit revisions.” Indiana's provision at IC 14-5-34-8.2(4) would make the provision at IC 14-34-5-8.1(8) all inclusive, thereby eliminating the possibility that a postmining land use change not listed at IC 14-34-5-8.1(8) could be considered a significant permit revision. Thus, the provision at IC 14-34-5-8.2(4) conflicts with Indiana's own reasonable definition of significant permit revisions. Our decision not to approve IC 14-34-5-8.2(2) is consistent with our approval of Indiana's reasonable definition of significant permit revisions.

The NMA points out that for almost twenty years, OSM has held that States do not have to adopt regulations that are identical to the Secretary's. Further, States do not need to demonstrate that alternative regulations are necessary to meet local requirements, environment, or agricultural conditions. Instead, States must demonstrate that their laws and regulations are as effective as the Secretary's in meeting the requirements of the Act. The NMA contends that there is no evidence in the record that IDNR's proposal would be less effective. The NMA states that OSM should be faithful to its longstanding policies of allowing States freedom to develop regulations that meet their needs, and approve the proposed amendment, especially when the evidence in the record supports the adoption of the proposed amendment and does not suggest that it would be less effective than OSM regulations. The NMA maintains that Indiana's proposed language is consistent with SMCRA section 511(a)(2).

Response: As explained under III. Director's Findings, the provision at IC 14-34-5-8.2(4) would eliminate the IDNR Director's discretion to determine if a revision other than those listed at IC 14-34-8.1(8) would constitute a significant permit revision and make it impossible for the IDNR Director to assure that appropriate procedures are provided for the public participation in the revision of reclamation plans as required under section 102(i) of SMCRA. Thus, Indiana's provision is less effective than the Secretary's regulations. Therefore, we are not approving it.

The NMA asserts that OSM failed to provide any new rationale or basis for not approving Indiana's proposed amendment at IC 14-34-5-8.2(4) in our January 11, 2001, Federal Register notice. The NMA contends that OSM has violated section 503(c) of SMCRA and section 553 of the Administrative Procedure Act by failing to allow the IDNR and the public a meaningful opportunity to comment on why OSM plans to deny the proposed amendments to the Indiana regulatory program. The NMA points to a Court ruling in Macon County Samaritan Memorial Hospital v. Shalala, 7 F. 3d 762, 765-766 (8th Cir. 1993); quoting Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 42 (1983) to argue that if a new agency rule reflects departure from the agency's prior policy, the agency must apply reasoned analysis for change beyond that which may be required when the agency does not act in the first instance. The NMA also points to a Court ruling in Office of Communications of the Unitied Church of Christ v. FCC, 560 F. 2d 529, 532 (2nd Cir. 1977) and contends that for an agency to change its previous holdings, there must be a thorough and comprehensive statement of reasons for the decision. The NMA states that it would be much more meaningful to provide comments as to whether Indiana's amendment satisfies the applicable program approval criteria of 30 CFR 732.15 if OSM explained in the notice exactly what part of the criteria the agency believes are not satisfied. The NMA states because OSM has chosen not to provide any additional information for the record and has not provided any new rationale for denying the amendment, the amendment should be approved. If OSM plans to attempt to not approve the amendment a second time, SMCRA and the APA require that it must at least provide the public and IDNR a meaningful opportunity to comment on that new rationale before the agency makes a final decision.

Response: SMCRA and the Federal regulations are clear as to the review and decision process for proposed changes to State programs. We have followed those procedures. The U.S. District Court, Southern District of Indiana, required us to reconsider our initial decision. Therefore, we provided an opportunity to the public to comment on the proposed amendment as required by law.

Based on the above findings, we are not approving the amendment as remanded to us for further consideration by the U.S. District Court, Southern District of Indiana on September 25, 2000.

To implement this decision, we are amending the Federal regulations at 30 CFR Part 914, which codify decisions concerning the Indiana program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the state's program demonstrates that the state has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effectively immediately will expedite that process and will encourage Indiana to bring its program into conformity with the Federal standards. SMCRA requires consistency of State and Federal standards.

Section 503 of SMCRA provides that a State may not exercise jurisdiction under SMCRA unless the State program is approved by the Secretary. Similarly, 30 CFR 732.17(a) requires that any alteration of an approved State program be submitted to OSM for review as a program amendment. The Federal regulations at 30 CFR 732.17(g) prohibit any changes to approved State programs that are not approved by OSM. In our oversight of the Indiana program, we will recognize only the statutes, regulations and other materials approved by the Secretary or by us, together with any consistent implementing policies, directives and other materials. We will require the enforcement by Indiana of only such provisions.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations.

This rule does not have federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary under SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed State regulatory program provision does not constitute a major Federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined 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. ). The State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

Section 503(a) of the Surface Mining Control and Reclamation Act (the Act) permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *” and “rules and regulations consistent with regulations issued by the Secretary” pursuant to the Act. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Pennsylvania program on July 30, 1982. You can find background information on the Pennsylvania program, including the Secretary's findings, the disposition of comments, and the conditions of the approval in the July 30, 1982, Federal Register (47 FR 33050). Subsequent actions concerning the conditions of approval and regulatory program amendments are codified at 30 CFR 938.11, 938.12, 938.15 and 938.16.

By letter dated January 3, 2001 (Administrative Record Number PA-875.00), the Pennsylvania Department of Environmental Protection (PADEP) submitted an amendment to its approved permanent regulatory program pursuant to the Federal regulations at 30 CFR 732.17(b). Pennsylvania included a cross reference dealing with prime farmlands to satisfy a required regulatory program amendment at 30 CFR 938.16(p) to make the Pennsylvania program consistent with the corresponding Federal regulations. The proposed rulemaking was published in the March 5, 2001 Federal Register (66 FR 13277). The public comment period closed on April 4, 2001. No member of the general public provided comments. No one requested an opportunity to speak at a public hearing, so no hearing was held.

Set forth below, pursuant to SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are the Director's findings concerning the amendments to the Pennsylvania permanent regulatory program.

PADEP is amending this subsection to include a reference to Chapter 88, Anthracite Coal. This subsection deals with the standards for Stage 2 bond release if prime farmlands are present and refers to reclamation plans for the various categories of coal mining. The previous version of this regulation contained references to Chapter 87, which relates to bituminous coal surface mining, Chapter 89, which relates to underground mining of bituminous coal and coal preparation facilities and Chapter 90, which relates to coal refuse disposal. This version did not contain a reference to Chapter 88, which relates to anthracite coal mining. This oversight was corrected when the regulations on post mining discharges, licensing and bonding became final, vol. 27, Pennsylvania Bulletin, no. 46, Page 6041, November 15, 1997. Subsection 86.174(b)(3), Page 6054, now states, in part, “* * * under the reclamation plan approved in Chapters 87-90.” The Director finds the proposed revision satisfies the required amendment codified in the Federal regulations at 30 CFR 938.16(p), and is therefore removing that required amendment.

On March 5, 2001, we asked for comments from various Federal agencies that may have an interest in the Pennsylvania amendment (Administrative Record Number 875.01.) We solicited comments in accordance with section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations.

In letters dated February 6 and 7, 2001, the Federal Mine Safety and Health Administration responded that, while it does not regulate bonding and reclamation of mined lands, the amendment appears adequate to ensure restoration of prime farmlands to full productivity after completion of mining. (Administrative Records Numbers PA-875.02 and PA 875.03.)

Pursuant to 30 CFR 732.17(h)(11)(i) and (ii), OSM is required to solicit comments from EPA on all amendments, and to obtain the written concurrence of the EPA with respect to those provisions of the proposed program amendment that relate to air or water quality standards promulgated under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). By letter dated January 31, 2001, we requested comments and concurrence from EPA, on the State's proposed amendment of January 3, 2001 (Administrative Record Number PA-875.00). EPA in its April 11, 2001, response letter (Administrative Record Number PA-875.05) stated that the proposed amendment complies with the Clean Water Act.

No comments were received in response to our request for public comments.

Based on the findings above we are approving the amendment to the Pennsylvania program.

The Federal regulations at 30 CFR part 938, codifying decisions concerning the Pennsylvania program, are being amended to implement this decision. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the state's program demonstrates that the state has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. Consistency of State and Federal standards is required by SMCRA.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart federal regulation.

This rule does not have federalism implications. SMCRA delineates the roles of the federal and state governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that state laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that state programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of state regulatory programs and program amendments since each such program is drafted and promulgated by a specific state, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed state regulatory programs and program amendments submitted by the states must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed state regulatory program provision does not constitute a major federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined 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. ). The state submittal which is the subject of this rule is based upon counterpart federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the state. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart federal regulation.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the state submittal which is the subject of this rule is based upon counterpart federal regulations for which an analysis was prepared and a determination made that the federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

The direct final rule (66 FR 21862) amended 33 CFR Part 164 to exclude public vessels owned, leased, or operated by the U. S. Government from requirements of carrying printed navigational charts and publications. The Coast Guard also published an Advance Notice of Proposed Rulemaking [66 FR 21899] seeking comments on the practicality of allowing all commercial vessels to use electronic systems for charting and navigation.

The Coast Guard received two comments on the rule. Both suggested that the rule specifically mention both operation under the Raster Chart Display System (RCDS) and the use of official Raster Navigation Charts (RNCs).

Let us note by way of clarification that the standards of the International Maritime Organization (IMO) for ECDIS permit the use of RNCs produced under the authority of a governmental hydrographic office. We agree that RNCs and RCDS currently meet those standards as “mode[s] of operation” (MSC 86(70)), and the rule allows the use of any electronic system for charting and navigation approved by the governmental agency exercising operational control over the vessel. Therefore, the rule needs no change to accommodate these comments. We hope this explanation avoids confusing those mariners who are already safely using RNCs and RCDS.

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 permit application did not allow sufficient time for publication of an NPRM followed by a temporary final rule effective 30 days after publication. Any delay of the effective date of this rule would be contrary to the public interest by exposing the public to the known dangers associated with fireworks displays and the possible loss of life, injury, and damage to property.

This Safety Zone is established to safeguard the public from the hazards associated with launching of fireworks by the Wisconsin Electric coal pile, Port Washington, Wisconsin. The size of the zone was determined by using previous experiences with fireworks displays in the Captain of the Port Milwaukee zone and local knowledge about wind, waves, and currents in this particular area.

The safety zone will be in effect on August 18, from 9:20 p.m. until 9:45 p.m.(CST). The safety zone will encompass all waters bounded by the arc of a circle with a 280-foot radius with its center in approximate position 43°23′07″N, 087°51′54″W, offshore of the Wisconsin Electric coal pile, Port Washington. Coordinates are North American Datum of 1983 (NAD83). The size of this zone was determined using the National Fire Prevention Association guidelines and local knowledge concerning wind, waves, and currents.

All persons and vessels shall comply with the instructions of the Captain of the Port Milwaukee or his designated on scene patrol personnel. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Milwaukee or his designated on scene representative. The Captain of the Port Milwaukee may be contacted via VHF 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 considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

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

This rule will affect the following entities: the owners or operators of vessels intending to transit or anchor in the vicinity of Port Washington harbor from 9:20 p.m. until 9:45 p.m. (CST) on August 18, 2001.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for only 25 minutes on one day and late in the day when vessel traffic is minimal. Vessel traffic may enter or transit through the safety zone with the permission of the Captain of the Port Milwaukee or his designated on scene representative. Before the effective period, we will issue maritime advisories widely available to users of Port Washington harbor.

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 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 Milwaukee (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).

We have analyzed this rule under Executive Order 13132 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 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 concern an environmental risk to health or risk to safety that may disproportionately affect children.

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34) (g), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation.

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.

Pursuant to 5 U.S.C. 553, a notice proposed rulemaking (NPRM) was not published for this regulation. Good cause exists for not publishing a NPRM and for making this regulation effective in less than 30 days after Federal Register publication. Details regarding this event were not provided to the Coast Guard in sufficient time to draft or publish a NPRM or a final rule 30 days in advance of its effective date. Publishing a NPRM and delaying its effective date would be contrary to the public interest since immediate action is needed to close a portion of the waterway and protect the maritime public from the hazards associated with this fireworks display.

This regulation establishes a safety zone in all waters within a 500-yard radius of the fireworks barge located approximately 300 yards west of Coasters Harbor, Narragansett Bay, Newport, Rhode Island, approximate position 41°30′12″N, 071°19′49″W on August 31, 2001, and September 1, 2001, from 6 p.m. until 10 p.m. Naval Station Newport has scheduled fireworks for August 31, 2001, and the regulation will be enforced from 6 p.m. to 10 p.m. Alternately, if the event is rescheduled due to weather, the safety zone will be enforced from 6 p.m. until 10 p.m. on September 1, 2001. This safety zone is needed to protect the maritime community from possible hazards associated with a fireworks display that will be shot from the barge off Coasters Harbor, Newport, Rhode Island. No vessel may enter the safety zone without permission of the Captain of the Port (COTP), Providence, Rhode Island.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary. This safety zone involves a very small area of Narragansett Bay, Newport, Rhode Island. The effect of this regulation will not be significant as the safety zone is effective for only four hours; it takes place late in the evening; it involves a very small area of Narragansett Bay, Newport, Rhode Island, thus allowing vessel traffic to safely transit around this safety zone; and extensive maritime advisories will be made in advance of the event.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit Newport, Rhode Island, in the fireworks area. The safety zone will not have a significant impact on a substantial number of small entities for the following reasons: the safety zone is effective for only four hours; it takes place late in the evening; the safety zone involves a very small area of Narragansett Bay, Newport, Rhode Island, thus allowing vessel traffic to safely transit around this safety zone; and extensive maritime advisories will be made in advance of the event.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If your small business or organization would be affected by this rule and you have any questions concerning its provisions or options for compliance, please call LT David Barata at (401) 435-2335. 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 collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this action under Executive Order 13132 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 having first provided the funds to pay those costs. This rule will not impose an unfunded mandate.

This temporary 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 temporary 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 temporary 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. A rule with tribal implications has a substantial direct effect on one or more Indian tribe, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Coast Guard has considered the environmental impact of implementing this temporary 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.

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.

Pursuant to sections 182(b)(2) and 182(f) of the Clean Air Act (CAA), the Commonwealth of Pennsylvania (the Commonwealth or Pennsylvania) is required to establish and implement RACT for all major volatile organic compounds (VOC) and NO X sources. The major source size is determined by its location, the classification of that area and whether it is located in the ozone transport region (OTR). Under section 184 of the CAA, RACT as specified in sections 182(b)(2) and 182(f) applies throughout the OTR. The entire Commonwealth is located within the OTR. Therefore, RACT is applicable statewide in Pennsylvania.

State implementation plan revisions imposing reasonably available control technology (RACT) for three classes of VOC sources are required under section 182(b)(2). The categories are: (1) All sources covered by a Control Technique Guideline (CTG) document issued between November 15, 1990 and the date of attainment; (2) All sources covered by a CTG issued prior to November 15, 1990; (3) All other major non-CTG rules were due by November 15, 1992. The Pennsylvania SIP has approved RACT regulations and requirements for all sources and source categories covered by the CTG's.

On February 4, 1994, PADEP submitted a revision to its SIP to require major sources of NO X and additional major sources of VOC emissions (not covered by a CTG) to implement RACT. The February 4, 1994 submittal was amended on May 3, 1994 to correct and clarify certain presumptive NO X RACT requirements. In the Pittsburgh area, a major source of VOC is defined as one having the potential to emit 50 tons per year (tpy) or more, and a major source of NO X is defined as one having the potential to emit 100 tpy or more. Pennsylvania's RACT regulations require sources, in the Pittsburgh area, that have the potential to emit 50 tpy or more of VOC and sources which have the potential to emit 100 tpy or more of NO X comply with RACT by May 31, 1995. The regulations contain technology-based or operational “presumptive RACT emission limitations” for certain major NO X sources. For other major NO X sources, and all major non-CTG VOC sources (not otherwise already subject to RACT under the Pennsylvania SIP), the regulations contain a “generic” RACT provision. A generic RACT regulation is one that does not, itself, specifically define RACT for a source or source categories but instead allows for case-by-case RACT determinations. The generic provisions of Pennsylvania's regulations allow for PADEP to make case-by case RACT determinations that are then to be submitted to EPA as revisions to the Pennsylvania SIP.

On March 23, 1998 EPA granted conditional limited approval to the Commonwealth's generic VOC and NO X RACT regulations (63 FR 13789). In that action, EPA stated that the conditions of its approval would be satisfied once the Commonwealth either (1) certifies that it has submitted case-by-case RACT proposals for all sources subject to the RACT requirements currently known to PADEP; or (2) demonstrates that the emissions from any remaining subject sources represent a de minimis level of emissions as defined in the March 23, 1998 rulemaking. On April 22, 1999, PADEP made the required submittal to EPA certifying that it had met the terms and conditions imposed by EPA in its March 23, 1998 conditional limited approval of its VOC and NO X RACT regulations by submitting 485 case-by-case VOC/NO X RACT determinations as SIP revisions and making the demonstration described as condition 2, above. EPA determined that Pennsylvania's April 22, 1999 submittal satisfied the conditions imposed in its conditional limited approval published on March 23, 1998. On May 3, 2001 (66 FR 22123), EPA published a rulemaking action removing the conditional status of its approval of the Commonwealth's generic VOC and NO X RACT regulations on a statewide basis. The regulation currently retains its limited approval status. Once EPA has approved the case-by-case RACT determinations submitted by PADEP to satisfy the conditional approval for subject sources located in Allegheny, Armstrong, Beaver, Butler, Fayette, Washington, and Westmoreland Counties; the limited approval of Pennsylvania's generic VOC and NO X RACT regulations shall convert to a full approval for the Pittsburgh area.

On April 9, 1999 and July 5, 2001, the PADEP submitted revisions to the Pennsylvania SIP which establish and impose RACT for several sources of NO X and VOCs. The RACT determinations for four of those sources, named below, are the subject of this rulemaking. These four sources are all located in the Pittsburgh area. The RACT determinations submitted for the other sources are or have been the subject of separate rulemakings.

The table below identifies the sources and the individual RACT operating permits (OPs) which are the subject of this rulemaking. A summary of the RACT determinations for each source follows the table.

The Lukens Steel Corporation's Houston Plant is a producer of rolled stainless steel sheet located in Houston Borough, Washington County, Pennsylvania. The facility is not a major VOC emitting source. The facility is a major source of NO X , and is a subject to RACT. The facility consists of two Electric Arc Furnaces (EAFs), an Argon Oxygen Decarburization (AOD) vessel, a continuous caster, a hot strip finishing mill, and a roughing and finishing mills. The facility also includes a number of preheat/heating/annealing metallurgical furnaces and heaters. Pennsylvania established NO X RACT requirements for the facility in OP 63-000-080.

(a) EAFs at the Melt Shop: Both EAFs are used at the plant to melt and refine the charge of metallic scrap, fluxes, and various alloying elements. The sufficient resistive heating is generated inside the refractory-lined furnace vessel by electrical current flowing between the three graphite electrodes and through the metallic charge. In spite of very high temperatures which arise inside the furnace during the melting phase, only modest NO X formation occurs. This is due to the fact that in the EAF process the generation of NO X is largely transferred from a steelmaking facility to an electric generating unit at a utility plant where those emissions are controlled.

(b) AOD Vessel at the Melt Shop: The AOD vessel is a refractory-lined furnace used in the ladle-metallurgical argon-oxygen decarburization process to refine stainless steel outside the EAF. During the oxygen-argon blowing, fluxes and alloy materials are added to the vessel. Immediately after the decarburization blow, molten steel is argon-stirred to achieve the desired chemical and temperature homogenization of the material.

(c) Preheat/Heating/Reheat/Annealing Furnaces: Preheat/heating/reheat furnaces are used to bring various semi-finished steel products to a uniform temperature in order to make them suitable for hot working. Annealing furnaces are used to refine the steel grain structure, to relief stresses induced by hot or cold working, and to alter the mechanical properties of steel in order to improve its malleability. Heat treatment of stainless steels is conducted at a slow rate and relatively low temperatures to minimize thermal stresses and to avoid distortion and cracking.

Of the fourteen NO X emitting installations/processes, nine are heating/reheat/annealing natural gas-fired furnaces and ladle or tundish preheaters with a rated gross heat input of less than 20 MMBTU/hr each. Pennsylvania has determined that these sources are subject to SIP-approved presumptive RACT requirements set forth in 25 Pa. Code Section 129.93.(c)(1). Two of the other five remaining sources are natural gas-fired recoil heating furnaces with a rated gross heat input equal to 20 MMBTU/hr. Pennsylvania has determined that these sources are subject to SIP-approved presumptive RACT requirements set forth in 25 Pa. Code Section 129.93.(b)(2). The remaining three sources are comprised of the two EAFs and the AOD vessel. A case-by-case RACT analysis was performed for those three installations/processes. The following NO X emission control options were evaluated: Low Excess Air (LEA), Flue Gas Recirculation (FGR), Modification of Process Equipment, Selective Catalytic Reduction (SCR), Selective Non-Catalytic Reduction (SNCR), and Wet Scrubber Oxidation/Reduction Process. Pennsylvania's determinations of NO X RACT requirements for those three installations are based on a detailed case-by-case analysis of whether or not the evaluated control technologies were economically and technically feasible options in each particular application.

(a) EAFs: Pennsylvania has concluded that the equipment and technology currently in place are constitute RACT for the source. Operating permit 63-000-080 requires that these sources be operated in accordance with the manufacturer's specifications and good operating/management practices. The OP also limits NO X emissions from the two EAFs to 13 lb/hr and 51 tons per year (tpy) in any 12 month consecutive period.

(b) AOD Vessel: Pennsylvania has concluded that the equipment and technology currently in place are constitute RACT for the source. In OP63-000-080, Pennsylvania imposes a requirement to operate the source in accordance with the manufacturer's specifications and good operating/management practices. The OP also limits NO X emissions from the AOD vessel to 10 lb/hr and 44 tpy in any 12 month consecutive period.

(c) Recoil Furnaces at the Hot Strip Mill: In addition to requiring these furnaces to meet SIP-approved presumptive RACT emission limitations, OP-63-000-080 also limits NO X emissions from these sources to 5.6 lb/hr and 25 tpy in any 12 month consecutive period. In addition, OP 63-000-080 limits total facility wide NO X emissions to no more than 136 tpy in any 12 month consecutive period.

The Allegheny Ludlum Steel Corporation's West Leechburg Plant is a producer of stainless and silicon steel strip located in Westmoreland County, Pennsylvania. The facility is not a major VOC emitting source. The facility is a major NO X emitting source, and is a subject to NO X RACT regulations. The facility is comprised of twenty-seven NO X emitting individual installations and processes. Pennsylvania established NO X RACT requirements for the facility in OP 65-000-183.

The West Leechburg Plant is primarily a finishing and rolling facility. The hot rolled and cold reduced strip steel is either annealed, annealed and pickled, blasted and pickled, or normalized depending on its metallurgy and end use. Most of the NO X emitting installations and processes at the facility are associated with the combustion of natural gas. The NO X emitting sources include heating, reheat and annealing furnaces of various gross heat input rates, coal and natural gas fired boilers and nitric/hydrofluoric acid pickling operations. The description of the major NO X emitting installations and processes provided for the Lukens Steel Corporation's facility, above, also describe those at Allegheny Ludlum Steel Corporation's West Leechburg Plant.

Pennsylvania has determined that fifteen various metallurgical furnaces and boilers are subject to the SIP-approved presumptive RACT emission limitations in 25 Pa. Code Section 129.93(b)(2) and (c)(1). For the remaining twelve NO X emitting sources, a detailed case-by-case NO X RACT analysis was performed in order to evaluate what control technology is both economically and technically feasible in each particular application. The following NO X emission control options were evaluated: Low Excess Air (LEA), Low-NO X Burners (LNB), LNB combined with Flue Gas Recirculation (FGR), Selective Catalytic Reduction (SCR), Selective Non-Catalytic Reduction (SNCR), Absorption, Oxidation/Absorption, and Hydrogen Peroxide Injection. Pennsylvania OP-65-000-183 requires that these numerous small sources operate and be maintained in accordance with the manufacturer's specifications and good operating procedures. Furthermore, each of these individual emitting sources is subject to an hourly NO X emission rate (pounds/hr) and annual NO X emission rate (tpy) to be met in any consecutive 12 month period. Finally OP 65-000-183 imposes a total facility wide cap of 874 tons per year also to be met in any consecutive 12 month period.

The Allegheny Ludlum Corporation, Jessop Steel Company's Washington Plant is a specialty steel producer located in Washington County, Pennsylvania. Pennsylvania issued the facility OP63-000-027, and therein limits total facility wide emissions of VOC to 4.5 tpy in any 12 month consecutive period. Therefore, the facility is not a major source of VOC. The facility is a major source of NO X , and is a subject to NO X RACT regulations. The facility is comprised of thirty individual NO X emitting installations and processes. Pennsylvania established NO X RACT requirements for the facility in OP63-000-027.

The Washington facility processes semi-finished stainless and tool grade steel products for specific customer use. The stainless or tool grade steel strip is either annealed, annealed and pickled, or blasted and pickled depending on its metallurgy and end use. Most of the NO X emitting installations and processes at the facility are gas fired small heating/reheat/annealing furnaces with rated heat input of less than 20 MMBTU/hr. There are also a few sources, such as a batch pickling operation, which are not associated with combustion process but still generate some NO X emissions. The description of the major NO X emitting installations and processes provided for the Lukens Steel Corporation's facility, above, also describe those at the Allegheny Ludlum Corporation, Jessop Steel Company's Washington Plant. It should be noted that the facility's three Electric Arc Furnaces (EAFs), the Argon Oxygen Decarburization (AOD) vessel and two AOD preheaters were shutdown on July 1, 1994. Allegheny Ludlum has filed for Emission Reduction Credits (ERCs) in accordance with 25 PA Code Section 127.207(5)(I) for the emissions reductions, beyond those required as RACT, from these shutdown units.

Pennsylvania has determined that twenty-four installations and processes are subject to the SIP-approved presumptive RACT emission limitations set forth in 25 Pa. Code Section 129.93(b)(2) and (c)(1). For the remaining six NO X emitting sources, a case-by-case NO X RACT analysis was performed in order to evaluate whether any additional control technology is both technically and economically feasible. The following NO X emission control options were evaluated: Low Excess Air (LEA), Low-NO X Burners (LNB), LNB Flue Gas Recirculation (FGR), Selective Catalytic Reduction (SCR), Selective Non-Catalytic Reduction (SNCR), Absorption, Oxidation/Absorption, and Hydrogen Peroxide Injection. Pennsylvania determined that operation of the existing equipment in accordance with the manufacturer's specifications and good engineering and pollution control practices constitutes RACT for the sources. Furthermore, each of these individual emitting sources is subject to an hourly NO X emission rate (pounds/hr) and annual NO X emission rate (tpy) to be met in any consecutive 12 month period. Finally OP63-000-027 imposes a total facility wide cap of 191.6 tpy to be met in any 12 month consecutive period.

The Koppel Steel Corporation's Koppel Plant is a producer of carbon and alloy grades steel located in Koppel Borough, Beaver County, Pennsylvania. The facility is comprised of twelve major NO X emitting individual installations and processes . Pennsylvania established NO X RACT requirements for the facility in OP-04-000-059. The facility is not a major source of VOCs. The facility is a major NO X emitting source, and is a subject to NO X RACT regulations.

The processes at this facility involve steel melting operations and the subsequent production of hot rolled bars in both carbon and alloy grades. The facility's Melt Shop consists of an Electric Arc Furnaces (EAF), a ladle refining station, a continuous caster and various pieces of ancillary equipment. Other NO X emitting installations and processes at the facility include various metallurgical furnaces, ladle and tundish dryers and heaters, torches, and boilers. The description of the major NO X emitting installations and processes provided for the Lukens Steel Corporation's facility, above, also describe those at the Koppel Steel Corporation, Koppel Plant.

Of the twelve NO X emitting units/processes, nine are heating/reheat/annealing natural gas-fired furnaces and ladle/tundish dryers and heaters with a rated gross heat input of less than 20 MMBTU/hr each. Pennsylvania has determined that these sources are subject to the SIP-approved presumptive RACT requirements set forth in 25 Pa. Code Section 129.93(c)(1). The remaining three sources are comprised of the EAF, ladle refining station, and the Rotary Hearth Reheat furnace. A case-by-case RACT analysis was performed for those three installations and processes with the following NO X emission control options evaluated: Low Excess Air (LEA), Flue Gas Recirculation (FGR), and Selective Non-Catalytic Reduction (SNCR). Pennsylvania's determinations of NO X RACT requirements for those three installations were based on a detailed case-by-case analysis of whether or not the evaluated control technologies were technically and economically feasible options in each particular application.

(a) The EAF and ladle refining station: Pennsylvania determined that the equipment and technology currently in place are constitute RACT for these sources. In OP04-000-059, Pennsylvania requires these units to operate and be maintained in accordance with the manufacturer's specifications and good air pollution control practices.

(b) The Rotary Hearth Reheat furnace: Pennsylvania has determined that the use of LEA at approximately 10% (in addition to the requirement to provide an annual adjustment or tune up of the combustion process) constitutes RACT for this source and, accordingly, imposes those requirements in its RACT OP-04-000-059.

EPA is approving Pennsylvania's RACT SIP submittals because PADEP established and imposed these RACT requirements in accordance with the criteria set forth in its SIP-approved RACT regulations. The Commonwealth has also imposed record-keeping, monitoring, and testing requirements on these sufficient to determine compliance with the applicable RACT determinations.

EPA is approving the SIP revisions to the Pennsylvania SIP submitted by PADEP to establish and require NO X RACT for four major sources located in the Pittsburgh area. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on October 1, 2001 without further notice unless EPA receives adverse comment by September 14, 2001. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if adverse comment is received for a specific source or subset of sources covered by an amendment, section or paragraph of this rule, only that amendment, section, or paragraph for that source or subset of sources will be withdrawn.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.” See 66 FR 28355, May 22, 2001. This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (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. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability establishing source- specific requirements for four named sources.

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 October 15, 2001. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving the Commonwealth's source-specific RACT requirements to control NO X from four individual steel facilities in the Pittsburgh-Beaver Valley nonattainment area in Pennsylvania may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

In Title 40 of the Code of Federal Regulations, parts 72 to 80, revised as of July 1, 2000, § 72.2 is corrected by removing the definition of Protocol 1 gas and by adding the definition of Standard reference material or SRM to read as follows:

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

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

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to 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. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301158. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of May 9, 2001 (66 FR 23695) (FRL-6780-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170) announcing the filing of a pesticide petition (PP 1E6281) by Stockhausen, Inc., 2401 Doyle Street, Greensboro, NC 27406. This notice included a summary of the petition prepared by the petitioner. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.1001(c) be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, sodium salt, polymer with 2-propenamide; CAS Reg. No. 25987-30-8.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for 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(c)(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 an exemption from the requirement of 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....” and specifies factors EPA is to consider in establishing an exemption.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d).

1. The polymer, 2-propenoic acid, sodium salt, polymer with 2-propenamide is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. 2-Propenoic acid, sodium salt, polymer with 2-propenamide does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. 2-Propenoic acid, sodium salt, polymer with 2-propenamide does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. 2-Propenoic acid, sodium salt, polymer with 2-propenamide is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. 2-Propenoic acid, sodium salt, polymer with 2-propenamide is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. 2-Propenoic acid, sodium salt, polymer with 2-propenamide is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer, 2-propenoic acid, sodium salt, polymer with 2-propenamide, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average MW of 18,000 daltons is greater than 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.

Thus, 2-propenoic acid, sodium salt, polymer with 2-propenamide meets all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, sodium salt, polymer with 2-propenamide.

For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, sodium salt, polymer with 2-propenamide could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, sodium salt, polymer with 2-propenamide is 18,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, sodium salt, polymer with 2-propenamide conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” The Agency has not made any conclusions as to whether or not 2-propenoic acid, sodium salt, polymer with 2-propenamide share a common mechanism of toxicity with any other chemicals. However, 2-propenoic acid, sodium salt, polymer with 2-propenamide conform to the criteria that identify a low risk polymer. Due to the expected lack of toxicity based on the above conformance, the Agency has determined that a cumulative risk assessment is not necessary.

Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population from aggregate exposure to residues of 2-propenoic acid, sodium salt, polymer with 2-propenamide.

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 unless EPA concludes that a different margin safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, sodium salt, polymer with 2-propenamide, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

There is no available evidence that 2-propenoic acid, sodium salt, polymer with 2-propenamide is an endocrine disruptor.

There are no other exemptions from the requirement of a tolerance.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

The Agency is not aware of any country requiring a tolerance for 2-propenoic acid, sodium salt, polymer with 2-propenamide nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Accordingly, EPA finds that exempting residues of 2-propenoic acid, sodium salt, polymer with 2-propenamide from the requirement of a tolerance will be safe.

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-301158 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 October 15, 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. M3708, Waterside Mall, 1200 Pennsylvania Ave., NW., 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 VIII.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 docket control number OPP-301158, 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 in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

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

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

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 rule in the Federal Register . This 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/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301153. 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 insecticide bifenazate, (hydrazine carboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl-, 1-methylethyl ester) and diazenecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl-, 1-methylethyl ester, in or on hop at 15 parts per million (ppm) and pear at 0.50 ppm. These tolerances will expire and are revoked on June 30, 2003. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

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

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

The two-spotted spider mite is a serious problem in Northwest hop yards due to the prolific nature of this pest and its ability to develop multiple generations in one season. This mite has a history of developing rapid resistance to insecticides used on hops, which have been documented through field studies and failures observed in commercial plantings. There are currently no effective late-season miticides registered for use on hops.

Abamectin has good activity against mites in the early season when foliage is young and uptake is optimum. It has provided over 90% of mite control for the past 11 years, but due to a lack of alternative modes of action, its efficacy and residual effect have declined significantly.

The Applicant proposes to replace abamectin with bifenazate for early season mite control. Only one application of bifenazate will be allowed, compared to the current two applications allowed for abamectin. Although bifenazate is moderately harmful to some predator species, approximately 50% survival is anticipated. With the addition of one application of hexythiazox, these two treatments should be adequate to control early season mites (prior to bloom).

Spider mites are a ubiquitous and perennial pest of pears in Washington and Oregon. They have a history of rapidly developing resistance to acaricides, and have evolved resistance to every pesticide directed at their control. For the past 10-12 years, growers have relied heavily on abamectin to control spider mites in pears. Prior to the use of abamectin, the primary control for mites was organotins (especially cyhexatin) for control. Resistance to abamectin in the Northwest mite populations has been documented. This resistance to the only consistently effective mite control creates the potential for severe losses to pear production in the Northwest. In recent years, pear growers have continued to use abamectin, and been faced with limited success. They have been forced to augment abamectin with other acaricides, such as fenbutatin-oxide and hexythiazox. However, resistance was documented during the 2000 growing season to the few viable alternatives to abamectin. Entering the 2001 growing season, there are no viable acaricides for which resistance does not occur in pears in Washington. Resistance to many of these products has also been observed in Oregon.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of bifenazate in or on hops and pears. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on June 30, 2003, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on hops and pears 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 bifenazate meets EPA's registration requirements for use on hops or pears or whether a permanent tolerance for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of bifenazate 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 Idaho and Washington to use this pesticide on these crops 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 bifenazate, 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 bifenazate and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for combined residues of bifenazate in or on hop at 15 ppm and pear at 0.50 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 bifenazate used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Bifenazate is currently only registered for use on ornamental plants and trees. An emergency exemption was granted earlier in 2001 for use of bifenazate on greenhouse grown tomatoes and a time-limited tolerance for residues on tomatoes was established. There are no other tolerances established for the combined residues of bifenazate. Risk assessments were conducted by EPA to assess dietary exposures from bifenazate in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. An acute dietary endpoint for females 13-50 years old or the general U.S. population was not selected due to the absence of an effect of concern occurring as a result of a 1 day or single exposure.

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

iii. Cancer . Bifenazate has been classified as “not likely” to be a human carcinogen based on carcinogenicity studies in mice and rats in which there were an absence of treatment-related tumors.

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

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

Based on the GENEEC and SCI-GROW models, the estimated environmental concentrations (EECs) of bifenazate for chronic exposures are estimated to be 0.02 part per billion (ppb) for surface water and 0.02 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).

Bifenazate is currently registered for use on the following residential non-dietary sites: ornamental plants and trees. The risk assessment was conducted using the following exposure assumptions: There is a potential for residential exposures, including homeowner applicator exposure and post-application exposures, for the currently registered uses of bifenazate. However, since broad spectrum insecticides are generally used in the residential setting, application of bifenazate (a selective insecticide) by a homeowner is expected to be limited. Nevertheless, a homeowner applicator is anticipated to have short-term dermal and inhalation exposures. Exposure estimates were based on the applicator wearing short pants and short sleeves.

The registered use of bifenazate on ornamentals is also expected to result in residential post-application exposure. The exposure estimate for homeowners and children was based on the default assumptions for treatment to garden plants from the Agency's Standard Operating Procedures (SOPs) for Residential Exposure Assessment (December 18, 1997). Only short-term dermal exposures are anticipated.

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

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

ii. Developmental toxicity studies . In a developmental toxicity study in rats the maternal toxicity NOAEL was 10 milligrams/kilograms/day (mg/kg/day) based on clinical signs and decreased body weight gains and food consumption at the LOAEL of 100 mg/kg/day. The developmental NOAEL was greater than 500 mg/kg/day (HDT) and the developmental LOAEL was not established. Therefore, there were no developmental effects observed in the presence of maternal toxicity in this study.

In a developmental toxicity study in rabbits there were no toxic effects up to the highest dose tested of 200 mg/kg/day in either the maternal animals or the fetuses. Although no toxicity was observed in this study, sufficient evidence of adequate dose selection was based on a range-finding study which was performed at doses of 0, 125, 250, 500, 750, or 1,000 mg/kg/day. Abortions were seen at 250 mg/kg/day and above and deaths and decreased body weight were seen at 750 mg/kg/day and 1,000 mg/kg/day. Based on these results, doses of 10, 50, and 200 mg/kg/day were selected for the main study.

iii. Reproductive toxicity study . In a 2-generation reproductive toxicity study in rats, the parental toxicity NOAEL was 20 ppm (equivalent to 1.6/1.8 mg/kg/day (males/females)) based on decreased body weight and cumulative weight gain in males and females at the LOAEL of 80 ppm (equivalent to 6.5/7.4 mg/kg/day (males/females)). The NOAEL for offspring toxicity and reproductive toxicity was 200 ppm (equivalent to 16.4/18.3 mg/kg/day (males/females)) which was the highest dose tested. A LOAEL for offspring toxicity and reproductive toxicity was not established.

iv. Prenatal and postnatal sensitivity. Based on the results of the developmental and reproduction studies, there is no indication of increased sensitivity in rats or rabbits to in utero and/or postnatal exposure to bifenazate.

v. Conclusion . There were no developmental or reproductive effects observed in the presence of maternal toxicity. However, bifenazate 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, EPA concludes with reasonable certainty that exposures to bifenazate in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA 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, EPA will reassess the potential impacts of bifenazate on drinking water as a part of the aggregate risk assessment process.

1. Acute risk . An acute dietary endpoint for females 13-50 years old or the general US population was not selected due to the absence of an effect of concern in studies conducted for bifenazate occurring as a result of a 1 day or single exposure. Therefore, no acute dietary risk assessments were conducted for bifenazate.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to bifenazate from food will utilize 34% of the cPAD for the U.S. population, 65% of the cPAD for infants and 48% of the cPAD for children (7-12 years), the most highly exposed children's subgroup. Based on the use pattern, chronic residential exposure to residues of bifenazate is not expected. In addition, despite the potential for chronic dietary exposure to bifenazate in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of bifenazate 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). Bifenazate 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 bifenazate.

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 1,300 to 1,400 for short-term dermal, inhalation and incidental oral exposures. 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 bifenazate 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 3:

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

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

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,”“Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301157. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of May 9, 2001 (66 FR 23695) (FRL-6780-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170) announcing the filing of a pesticide petition (PP 1E6282) by Stockhausen, Inc., 2401 Doyle Street, Greensboro, NC 27406. This notice included a summary of the petition prepared by the petitioner. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.1001(c) be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, polymer with 2-propenamide, sodium salt; CAS Reg. No. 25085-02-3.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for 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(c)(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 an exemption from the requirement of 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....” and specifies factors EPA is to consider in establishing an exemption.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d).

1. The polymer, 2-propenoic acid, polymer with 2-propenamide, sodium salt is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. 2-Propenoic acid, polymer with 2-propenamide, sodium salt does contain as an integral part of its compostion the atomic elements carbon, hydrogen, and oxygen.

3. 2-Propenoic acid, polymer with 2-propenamide, sodium salt does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. 2-Propenoic acid, polymer with 2-propenamide, sodium salt is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. 2-Propenoic acid, polymer with 2-propenamide, sodium salt is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. 2-Propenoic acid, polymer with 2-propenamide, sodium salt is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer, 2-propenoic acid, polymer with 2-propenamide, sodium salt, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average MW of 18,000 daltons is greater than 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.

Thus, 2-propenoic acid, polymer with 2-propenamide, sodium salt meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, polymer with 2-propenamide, sodium salt.

For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, polymer with 2-propenamide, sodium salt could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, polymer with 2-propenamide, sodium salt is 18,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, polymer with 2-propenamide, sodium salt conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” The Agency has not made any conclusions as to whether or not 2-propenoic acid, polymer with 2-propenamide, sodium salt share a common mechanism of toxicity with any other chemicals. However, 2-propenoic acid, polymer with 2-propenamide, sodium salt conform to the criteria that identify a low risk polymer. Due to the expected lack of toxicity based on the above conformance, the Agency has determined that a cumulative risk assessment is not necessary.

Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population from aggregate exposure to residues of 2-propenoic acid, polymer with 2-propenamide, sodium salt.

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 unless EPA concludes that a different margin safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, polymer with 2-propenamide, sodium salt, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

There is no available evidence that 2-propenoic acid, polymer with 2-propenamide, sodium salt is an endocrine disruptor.

There are no other exemptions from the requirement of a tolerance.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

The Agency is not aware of any country requiring a tolerance for 2-propenoic acid, polymer with 2-propenamide, sodium salt nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Accordingly, EPA finds that exempting residues of 2-propenoic acid, polymer with 2-propenamide, sodium salt from the requirement of a tolerance will be safe.

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-301157 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 October 15, 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. M3708, Waterside Mall, 1200 Pennsylvania Ave., NW., 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 VIII.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 docket control number OPP-301157, 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 an exemption from the tolerance requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have“ substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

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 rule in the Federal Register . This 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 this table could also be affected. The North American Industrial Classification System (NAICS) codes are 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-301152. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-301152 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically. You may submit your comments electronically by e-mail to: opp-docket@epa.gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-301152. Electronic comments may also be filed online at many Federal Depository Libraries.

EPA is issuing this action as a direct final rule without prior proposal because the Agency believes that this action is not controversial and will not result in any adverse comments. If no relevant adverse comment is submitted within 30 days of publication, this action will become effective 90 days after publication without any further action by the Agency. If, however, a relevant adverse comment is received during the comment period, this direct final rule will be withdrawn and the public comments received will be addressed in a subsequent final rule, or EPA may request additional public comments.

For the reasons set forth above, EPA believes that it is appropriate to issue this rule as a direct final rule. In addition, this rule also conforms with the “good cause” exemption under section 553(b)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(B)), which allows agencies to issue an action without additional notice and comment if further notice and comment would be unnecessary.

On its own initiative, the Agency is amending 40 CFR 180.1001 and 180.1026 by its intent to revoke exemptions from the requirement of a tolerance for 10 inert ingredients that are duplicates. No uses of these inert ingredients will be lost as a result of these tolerance exemption revocations.

1. In 40 CFR 180.1026 there is an exemption from the requirement of a tolerance for N,N-diallydichloroacetamide (dichlormid) when used as an inert ingredient in formulations of the herbicides S-ethyl diisobutylthiocarbamate, S-ethyl dipropylthiocarbamate, and S-propyl dipropylthiocarbamete when applied to cornfields before the corn plants emerge from the soil. The Agency's records indicate that dichormid is no longer used with any of these aformentioned active ingredients in pesticide products. This action revokes these exemptions. However, should any uses remain, they would be covered under the existing time-limited tolerances in 40 CFR 180.469 which the Agency established on March 27, 2000 (65 FR 16143) (6498-7). These time-limited tolerances are for residues of dichlormid (N,N-diallyldichloroacetamide (CAS Reg. No. 37764-25-3)) when used as an inert ingredient (safener) in pesticide formulations applied to corn commodities before the corn plants emerge from the soil in or on the following food commodities: corn, field, forage, 0.05 ppm; corn, field, grain, 0.05 ppm; corn, field, stover, 0.05 ppm; corn, pop, grain, 0.05 ppm; corn, pop, stover, 0.05 ppm. These tolerances expire March 27, 2002.

2. In 40 CFR 180.1001(c) there are two entries for poly(vinyl pyrrolidone). One has a molecular weight of 4,000 amu and the other has a molecular weight of 40,000 amu. In the Federal Register of August 31, 1994 (59 FR 44956) (FRL-4906-1), the Agency issued a proposed rule which discussed pesticide petition (PP) 4E4308. This petition requested to amend 40 CFR 180.1001(c) by revising the then currently listed exemption from the requirement of a tolerance for residues of poly(vinylpyrrolidone) to lower the molecular weight from 40,000 amu to 4,000 amu. In the final rule which was published in the Federal Register on November 2, 1994 (59 FR 54825) (FRL-4914-1), the Agency inadvertently established a new tolerance exemption for poly (vinyl pyrrolidone) with a molecular weight of 4,000 amu instead of amending the existing tolerance exemption for poly(vinylpyrrolidone) polymers. The lower molecular weight polymer tolerance exemption would include those with the higher molecular weights. For this reason, this action revokes the exemption for poly(vinyl pyrrlidone) of molecular weights greater than 40,000 since it is duplicative and therefore not necessary.

3. In 40 CFR 180.1001(e) there are two entries for FD&C Blue No. 1. One is specified for use as a dye and the other is specified for use as a dye, coloring agent. Since the listing solely as a dye is covered by the other FD&C Blue No. 1 entry and is therefore a duplication, this action revokes the FD&C Blue No. 1 entry for use as a dye.

4. An exemption from the requirement of a tolerance for calcium hypochlorite for use as a sanitizing and bleaching agent is currently listed in both 40 CFR 180.1001(c) and (d). Residues of the inert ingredients contained in 40 CFR 180.1001(c) are exempted from the requirement of a tolerance when used in pesticide formulations that are applied to growing crops or to raw agricultural commodities after harvest in accordance with good agricultural practices. 40 CFR 180.1001(d) exempts residues of the inert ingredients when used in pesticide formulations that are applied to growing crops only. This action revokes the calcium hypochlorite tolerance exemption in 40 CFR 180.1001(d), since 40 CFR 180.1001(d) is actually a subset of 40 CFR 180.1001(c).

5. There are two entries in 40 CFR 180.1001(d) for diethylene glycol. The first entry is limited to use as a “deactivator for formulations used before the crop emerges from soil” and the second entry is limited to use as a “deactivator, adjuvant for formulations used before crop emerges from the soil.” These entries are duplicative. Therefore, this action revokes the diethylene glycol entry limited to use as a deactivator for formulations used before crop emerges from the soil.

6. There are duplicate exemptions from the requirement of a tolerance for 1,1,1-trichloroethane in 40 CFR 180.1001(e). One is limited to presence in formulations not to exceed 25% of the pesticide formulation while the other one does not have any limits. This action revokes the 1,1,1-trichloroethane exemption limited to exceed 25% of the pesticide formulation, since the unlimited tolerance exemption includes this limitation.

7. Exemptions from the requirement of a tolerance for isopropyl alcohol are in 40 CFR 180.1001(c) and (d). This action revokes the exemption from a requirement of a tolerance in 40 CFR 180.1001(d) for isopropyl alcohol since as previously stated 40 CFR 180.1001(d) is a subset of 40 CFR 180.1001(c).

8. There are duplicate exemptions from the requirement of a tolerance for n -propanol in 40 CFR 180.1001(c) and (d). The exemption from the requirement of a tolerance of n -propanol in 40 CFR 180.1001(c) is for use for a solvent and co-solvent. The exemption from the requirement of a tolerance for n -propanol in 40 CFR 180.1001(d) is for use as a solvent for blended emulsifiers. This action revokes the exemption in 40 CFR 180.1001(d) for n -propanol since this use is included in 40 CFR 180.1001(c).

9. There are duplicate exemptions from the requirement of a tolerance for epoxidized soybean oil in 40 CFR 180.1001(e). One has the use as a stabilizer, while the other has the use as a “stabilizer, plasticizer, component animal tag.” This action revokes the exemption for epoxidized soybean oil with the use as a stabilizer since the use as a stabilizer is included in the epoxidized soybean oil exemption with uses as a “stabilizer, plasticizer, and component of animal tag.”

10. Exemptions from the requirement of a tolerance for sodium mono-di-and tri-isopropyl napthalene sulfonate are in both 40 CFR 180.1001(c) and (d). This action revokes the exemption from a requirement of a tolerance in 40 CFR 180.1001(d) for sodium mono-di-and tri-napthalene sulfonate since as previously stated 40 CFR 180.1001(d) is a subset of 40 CFR 180.1001(c).

This direct final rule is issued pursuant to section 408(e) of FFDCA, 21 U.S.C. 346a(e), as amended by the FQPA (Public Law 104-170). Section 408 of FFDCA authorizes the establishment of tolerances, exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or tolerance exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under section 402(a) of the FFDCA. If food containing pesticide residues is found to be adulterated, the food may not be distributed in interstate commerce (21 U.S.C. 331(a) and 342(a)).

By law, EPA is required to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996, by August 2002. This direct final rule revokes 10 duplicative tolerance exemptions. Therefore, if there are no adverse comments, 90 days after publication of the direct final rule, one tolerance reassessment (for N,N diallydichloroacetamide) will be counted toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996. The other revoked tolerance exemptions will be counted toward tolerance reassessment when the remaining associated tolerance exemption is reassessed.

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” subject to review by the Office of Management and Budget (OMB).

This direct 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 special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

Under section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency hereby certifies that these proposed actions to amend/revise § 180.1001(c), (d), and (e) will not have a significant negative economic impact on a substantial number of small entities. This direct final rule will have no negative impact because it merely removes duplicative entries from the EPA regulations listing substances exempted from tolerances.

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 direct final rule does not affect States directly. 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 the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

i. The table in paragraph (c) is amended by removing the entire entry for Poly (vinyl pyrrolidone); molecular weight (in amu) 40,000 or over.

ii. The table in paragraph (d) is amended by removing the entire entry for Calcium hypochlorite; the entire second entry for Diethylene glycol; and the entire entries for Isopropyl alcohol; n -Propanol; and Sodium mono-, di-, and triisopropyl.

iii. The table in paragraph (e) is amended by removing the entire first entry for Epoxidized soybean oil; the entire first entry for FD&C Blue No. 1; and the entire second entry for 1,1,1-trichloroethane.

The Federal Communications Commission published a document adopting, inter alia, rule sections 68.106 through 68.610, which privatize and streamline part 68 terminal equipment procedures, in the Federal Register of January 24, 2001, (66 FR 7579). In FR Doc. 01-1034, published January 24, 2001 (66 FR 7579), make the following correction:

1. On page 7579, in the third column, correct the Dates caption to read as follows:

On December 21, 2000, the Commission adopted the Part 68 Streamlining Order which amended the Commission's rules governing the connection of terminal equipment to the public switched telephone network in an effort to privatize and streamline the standards development and approval processes; a summary of the order was published in the Federal Register . 66 FR 7579 (January 24, 2001). Some of the regulations adopted in that order included information collection that required approval from the Office of Management and Budget. The order explained that “[t]he collections of information contained within are contingent upon approval by the OMB. The Commission will publish a document at a later date establishing the effective date.” OMB approved the amendments to 47 CFR 68.106-68.610 that establish those reporting requirements. See OMB No. 3060-0056. Accordingly, these regulations became effective upon publication of a document in the Federal Register . This document constitutes publication of the effective date of the regulations.

Compliance with the requirement to register with NMFS and to obtain an authorization certificate is delayed until January 1, 2002, for fisheries added or elevated to Category II in this final rule. The delay affects the following fisheries: Atlantic blue crab trap/pot; California longline; North Carolina inshore gillnet; North Carolina long haul seine; Northeast drift gillnet; Northeast trap/pot; Virginia Pound net; and, Southeast Atlantic gillnet. Except for the delayed registration requirement, the above mentioned fisheries are considered to be Category II fisheries on the date that the 2001 LOF becomes effective, and are required to comply with all other requirements of Category II fisheries (i.e., comply with applicable take reduction plan requirements and carry observers if requested).

Under section 118 of the MMPA, NMFS must publish, at least annually, a LOF that places all U.S. commercial fisheries into one of three categories based on the level of incidental serious injury and mortality of marine mammals that occurs in each fishery. The categorization of a fishery in the LOF determines whether participants in that fishery may be required to comply with certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan requirements.

The definitions for the fishery classification criteria can be found in the implementing regulations for section 118 of the MMPA (50 CFR part 229). In addition, these definitions are summarized in the preambles to the final rule implementing section 118 (60 FR 45086, August 30, 1995), the final LOF for 1996 (60 FR 67063, December 28, 1995), and the proposed LOF for 2001 (66 FR 6545, January 22, 2001).

This final rule includes two tables that list all U.S. commercial fisheries by LOF Category. Table 1 lists all of the fisheries in the Pacific Ocean (including Alaska). Table 2 lists all of the fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean.

Owners of vessels or gear engaging in a Category I or II fishery are required under 50 CFR 229.4 to register with NMFS and obtain a marine mammal authorization from NMFS in order to lawfully incidentally take a marine mammal in a commercial fishery. Owners of vessels or gear engaged in a Category III fishery are not required to register with NMFS or obtain a marine mammal authorization.

You must register through NMFS’ Regional Offices (see ADDRESSES ) unless you participate in a fishery that has an integrated registration program. Upon receipt of a completed registration, NMFS will issue vessel or gear owners a decal or other physical evidence of a current and valid registration that must be displayed or that must be in the possession of the master of each vessel while fishing (MMPA Section 118(3)(A)).

For some fisheries, NMFS has integrated the MMPA registration process with existing state and Federal fishery license, registration, or permit systems and related programs. Participants in these fisheries are automatically registered under the MMPA and are not required to pay the $25 registration fee.

The following fisheries have integrated registration programs under the MMPA: all Alaska Category II fisheries; all Washington and Oregon Category II fisheries; the Gulf of Maine/U.S. Mid-Atlantic lobster trap/pot fishery; the Federal portion of the Northeast sink gillnet fishery; and, the Federal portion of the Atlantic squid, mackerel, butterfish trawl fishery. Special procedures and instructions for registration in these integrated fisheries are described in the preamble to the final LOF for 1998 (63 FR 5748, February 4, 1998).

The Regional Offices annually send renewal packets to participants in Category I or II fisheries that have previously registered; however, it is your responsibility to ensure that registration or renewal forms are submitted to NMFS at least 30 days in advance of fishing. If you have not received a renewal packet by January 1 or are registering for the first time, request a registration form from the appropriate Regional Office (see ADDRESSES ).

Any vessel owner or operator, or fisher (in the case of non-vessel fisheries), participating in a Category I, II, or III fishery must comply with 50 CFR 229.6 and report all incidental injuries or mortalities of marine mammals that occur during commercial fishing operations to NMFS. “Injury” is defined in 50 CFR 229.2 as a wound or other physical harm. In addition, any animal that ingests fishing gear or any animal that is released with fishing gear entangling, trailing, or perforating any part of the body is considered injured and must be reported. Instructions on how to submit reports can be found in 50 CFR 229.6.

Fishers participating in a Category I or II fishery are required to accommodate an observer aboard your vessel(s) upon request. Observer requirements can be found in 50 CFR 229.7.

Fishers participating in a Category I or II fishery are required to comply with any applicable take reduction plans. NMFS may develop and implement take reduction plans for any Category I or II fishery that interacts with a strategic stock.

NMFS reviewed the marine mammal incidental serious injury and mortality information presented in the Stock Assessment Reports (SARs) for all observed fisheries to determine whether changes in fishery classification were warranted. NMFS also reviewed other sources of new information, including marine mammal strandings data, observer program data, fisher self-reports, and other information that is not included in the SARs.

NMFS’ SARs provide the best available information on both the level of serious injury and mortality of marine mammals that occurs incidental to commercial fisheries and the Potential Biological Removal (PBR) levels for marine mammal stocks. PBR is defined by the MMPA as, “the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing the stock to reach or maintain its optimum sustainable population.”

The information contained in the SARs is reviewed by regional scientific review groups (SRGs) representing Alaska, the Pacific coast (including Hawaii), and the Atlantic coast (including the Gulf of Mexico). The SRGs were created by the MMPA to review the science that goes into the stock assessment reports and to advise NMFS on population status and trends, uncertainties in the science, research needs, and other issues.

The LOF for 2001 was based on information provided in the final SARs for 1996 (63 FR 60, January 2, 1998), the final SARs for 1999 (65 FR 12514, March 9, 2000), and the final SARs for 2000 (66 FR 15081, March 15, 2001). The final SARs for 1999 and 2000 provide new estimates of total serious injury and mortality of marine mammals that occur incidental to some U.S. commercial fisheries and provide new estimates of PBR levels for some marine mammal stocks.

NMFS received 13 comment letters on the proposed 2001 LOF (66 FR 6545). Issues outside the scope of the LOF were not responded to in this final rule. Typographic errors noted by commenters were corrected where appropriate.

Comment 1 : Three commenters stated that the registration requirement is unnecessary, the fee unjustified, and that the proposed rule does not explain how the marine mammal resource will benefit from registration.

Response : The MMPA requires that owners of a vessel engaged in a Category I or II fishery register and obtain an authorization for each vessel used in a Category I or II fishery and ensure that a decal or other physical evidence of a current and valid registration is displayed or in the possession of the master of each vessel (MMPA Section 118(3)(A)). The purpose of the registration requirement is to provide information that can be used to assess fishery efforts and their impacts on marine mammals (S Rep. No.220, 103rd Cong., 2d Sess. 6 (1994)). Section 118(5)(C) of the MMPA authorizes NMFS to charge a fee for the granting of an authorization. However, the level of fees charged may not exceed the administrative costs incurred in granting an authorization. Registration also serves to authorize the take of marine mammals incidental to commercial fishing operations.

NMFS recognizes that the registration requirement, although small, places a burden and expense on the participants in the fishery. To address this problem, NMFS has integrated the MMPA registration process with existing State and Federal fishery license, registration, or permit systems, when practicable, and will continue to work to integrate fisheries that have not yet been integrated. Participants in integrated fisheries are automatically registered under the MMPA and are not required to pay the registration fee. Refer to the section titled “Which Fisheries Have Integrated Registration Programs?” for additional information.

Comment 2 : One commenter stated that registering and authorizing fishermen in the Atlantic blue crab trap/pot fishery would be very difficult and would place an unnecessary burden and expense on the participants of the fishery.

Response : NMFS recognizes that there are a large number of participants in the Atlantic blue crab trap/pot fishery, and that registering and authorizing those fishers will place a burden on both fishery participants and NMFS. As a result, NMFS is in the process of working to integrate the MMPA registration process for those fishers with existing State and Federal fishery license, registration, or permit systems. Because this fishery is primarily prosecuted in State waters and authorized through State licenses, the success of integration will depend heavily on cooperative efforts with the various State fisheries agencies. Once integration is completed in states where it is possible, participants in this fishery would not be required to register separately under the MMPA or pay the $25 fee.

To provide additional time for NMFS to work with states to integrate the MMPA registration process with existing State or Federal license, registration, or permit systems, NMFS has delayed the compliance date for fisheries added or elevated to Category II in the 2001 LOF to register with NMFS and obtain an authorization certificate until January 1, 2002. The delay affects the following fisheries: Atlantic Blue Crab Trap/Pot; California Longline; North Carolina Inshore Gillnet; North Carolina Long Haul Seine; Northeast Drift Gillnet; Northeast Trap/Pot; Virginia Pound Net; and, Southeast Atlantic Gillnet. Except for the delayed registration requirement, NMFS emphasizes that these fisheries are considered to be Category II fisheries on the date that the 2001 LOF becomes effective, and are required to comply with all other requirements of Category II fisheries (i.e., comply with applicable take reduction plan requirements, carry observers if requested, and report all incidental injuries or mortalities of marine mammals that occur during commercial fishing operations to NMFS). Category I and II fisheries not listed above must be registered and obtain a valid authorization certificate.

Comment 3 : One commenter stated that the Southeastern U.S. Atlantic, Gulf of Mexico shrimp trawl fishery may warrant elevation to Category II. Interactions with bottlenose dolphin are documented and additional observer effort should be placed in this fishery. The commenter noted that gillnet fishermen in North Carolina have stated in public meetings that they believe dolphins preferentially follow and forage in and around shrimp boats, and could therefore become entangled in the nets.

Response : NMFS is evaluating stranding and observer data for this fishery to determine the degree of interaction between this fishery and marine mammals. NMFS will summarize the data in the proposed 2002 LOF.

Comment 4 : One commenter was concerned that gillnets in the Caribbean may be interacting with marine mammals in greater numbers than current data supports and recommended placing observers in these fisheries.

Response : NMFS is currently monitoring marine mammal strandings in the Caribbean to determine whether marine mammals are interacting with the Caribbean gillnet fishery.

Comment 5 : One commenter stated that the buoy that entangled a bottlenose dolphin in the Southeastern U.S. Atlantic, Gulf of Mexico stone crab trap/pot fishery was attached at the other end of the line to a cement block. This is an unorthodox practice, it is probably illegal, and it could have been done by anyone.

Response : NMFS agrees with the commenter. Further investigation indicated that this gear configuration is not a normal component of the stone crab fishery. NMFS will remove bottlenose dolphin (Eastern Gulf of Mexico coastal stock) from the species list for the Southeastern U.S. Atlantic, Gulf of Mexico stone crab trap/pot fishery.

Comment 6 : One commenter noted that there has never been a report of manatees becoming entangled in lobster or stone crab gear.

Response : Upon consultation with the Fish and Wildlife Service, which has jurisdiction over manatees, the report of a manatee entangled in the spiny lobster trap/pot fishery was determined to be incorrect and was removed from the citation in the 2001 LOF. NMFS did not identify a manatee interaction with the stone crab gear in the proposed 2001 LOF.

Comment 7 : One commenter noted that NMFS identified the stock of a bottlenose dolphin killed incidental to the Florida spiny lobster trap/pot fishery as from the Western North Atlantic coastal stock; however, the incident occurred in the Gulf of Mexico.

Response : NMFS agrees with the commenter. NMFS will remove the Western North Atlantic coastal stock of bottlenose dolphin from the Florida spiny lobster trap/pot fishery and replace it with the Eastern Gulf of Mexico coastal stock. NMFS notes that this animal was released alive although the condition of the animal was unknown.

Comment 8 : One commenter stated that using the two-tiered fishery classification criteria in combination with an overly precautionary PBR calculation methodology ensures that even a fishery with a very limited interaction level is listed under Category II.

Response : Section 118(c)(1)(A) of the MMPA requires NMFS to publish a list of commercial fisheries and classify each fishery based on whether it has a frequent (Category I), occasional (Category II), or remote likelihood or no known (Category III) incidental mortality and serious injury of marine mammals. To make an objective determination regarding what should be classified as “frequent”, “occasional”, or “remote,” NMFS developed criteria to use when mortality and serious injury data and abundance data are available. The fishery classification criteria consists of a two-tiered, stock-specific approach that first addresses the total impact of all fisheries on each marine mammal stock and then addresses the impact of individual fisheries on each stock. This approach is based on consideration of the rate, in numbers of animals per year, of incidental mortalities and serious injuries of marine mammals due to commercial fishing operations relative to the PBR level for each marine mammal stock. Thus, the rate of interaction of a fishery with a marine mammal stock with a low PBR can be significant even it appears to be a minimal problem based on the size of the fishery or frequency of interactions.

The MMPA defines PBR to mean, “the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population.” The PBR level is the product of the following factors: (a) the minimum population estimate of the stock, (b) one-half the maximum theoretical or estimated net productivity rate of the stock at a small population size, and (c) a recovery factor of between 0.1 and 1.0. The parameters in the PBR calculation are used because they are assumed to provide adequate accommodation of the amount of uncertainty observed in marine mammal and commercial fishery interactions. Extensive modeling has shown the PBR calculation to be robust to an appropriate range of bias and variance.

Additionally, in the absence of representative information indicating the frequency of incidental mortality and serious injury of marine mammals by a commercial fishery, NMFS determines whether the incidental serious injury or mortality is “occasional” by evaluating other factors such as fishing techniques, gear used, methods used to deter marine mammals, target species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, and the species and distribution of marine mammals in the area.

Comment 9 : One commenter supported elevation of the Northeast Trap/Pot Fishery.

Response : Comment noted. The reclassification includes a Category II designation for crab trap/pot fisheries such as red crab and jonah crab fisheries but also includes fisheries of other species groups, such as hagfish, that are also caught in traps and pots.

Comment 10 : One commenter supported elevation of this fishery to Category I.

Response : Comment noted. NMFS agrees and is elevating this fishery to Category I in the 2001 LOF.

Comment 11 : One commenter stated that the consideration for elevation of the Atlantic squid, mackerel, and butterfish trawl fishery to Category I was precipitated in part by the observed take of one white-sided dolphin and one pilot whale during 1996-1998. According to the commenter, the data were not available to determine the applicability of using the ratio estimator method to expand the dolphin take to 161 animals. The commenter also stated that this approach may be an improper manipulation of the data since no correlation exists between fish catch and marine mammal interactions, and further inspection of the trip-level information regarding these two incidents is necessary.

Response : The proposed elevation of this fishery was based on the data presented in the draft 2000 SAR, which indicated a serious injury/mortality rate of greater than 50 percent of the PBR for both pilot whale and common dolphin stocks. In the final 2000 SAR, the PBR of the pilot whale stock(s) was increased from 78 to 113. As a result, the incidental serious injury/mortality for that stock during the period of analysis for this LOF no longer exceeds 50 percent of the PBR. In the final 2000 SAR, the PBR for the common dolphin stock was also increased (from 107 to 227). However, the serious injury/mortality of this stock remains in excess of PBR. Thus, NMFS is elevating the fishery in this LOF, but the action is now based solely on takes of common dolphins. As described in the final 2000 SAR, 3 mortalities were observed in this fishery in 1996 and one in 1997. NMFS is not making a correlation between fish catch and marine mammal interactions. NMFS uses total landings as a proxy for effort.

NMFS data and analysis presented in the stock assessment reports are peer-reviewed and also made available for public review and comment, and we believe the data and analysis presented in the stock assessment reports are appropriate and scientifically justifiable. However, NMFS encourages the commenter to review and provide comment on the draft 2001 stock assessment reports.

Comment 12 : Comments were received both for and against elevation of this fishery. The commenters opposed to this action referenced problems with the coastal bottlenose dolphin stock assessment report with regard to stock size, stock structure, and PBR.

Response : NMFS has decided not to elevate the fishery at this time. Although a Category I designation is warranted based on estimates of take relative to the current PBR of 25 for this stock, NMFS has new information regarding the coastal bottlenose dolphin stock that was not available at the time of the preparation of the proposed LOF. Therefore, NMFS has determined that it is more appropriate to evaluate the appropriate categorization of this fishery once the new stock information has been reviewed through the NMFS stock assessment report process. The Mid-Atlantic coastal gillnet fishery remains in Category II in this LOF.

Comment 13 : One commenter stated that inappropriate data and analysis were used in the 2000 draft stock assessment reports for marine mammals that interact with the Atlantic pelagic longline fishery.

Response : NMFS believes data and analysis presented in the stock assessment reports are peer-reviewed and also made available for public review and comment, and we believe the data and analysis presented in the stock assessment reports are appropriate and scientifically justifiable. However, NMFS encourages the commenter to review and provide comment on the draft 2001 stock assessment reports.

Comment 14 : NMFS should remove the Atlantic pelagic drift gillnet fishery from the 2001 LOF because that fishery is now closed.

Response : NMFS proposed to remove this fishery from the LOF because NMFS regulations now prohibit driftnetting for the swordfish and tuna component of this fishery. The listing for the Atlantic Ocean, Caribbean, and Gulf of Mexico large pelagics drift gillnet fishery is removed in this LOF. Any large or small mesh drift gillnet fisheries that do occur are incorporated into other LOF gillnet listings.

Comment 15 : NMFS should review and revise, as necessary, the species listed for each fishery to ensure that only those species known to incur injury or mortality incidental to specific fisheries are listed. NMFS should delete species that have not been documented or otherwise verified to have been seriously injured or killed by pelagic longline fishing gear. The commenter specifically identified species that NMFS should review.

Response : NMFS will investigate whether the available data warrant changing the list of species that interact with this fishery. The species list in the LOF is reflective of historical information, rather than the most recent 5 years of data as presented in the SARs. The LOF tables list the marine mammal species/stocks incidentally injured or killed, including non-serious injuries, in each fishery based on observer data, logbook data, stranding reports, fishers’ reports, anecdotal reports, and other sources of information. The list of species/stocks in the LOF includes all species or stocks known to incur injury or mortality for a given fishery; however, not all species or stocks identified are necessarily independently responsible for a fishery’s classification.

Comment 16 : One commenter requested that NMFS subdivide the fishery into three regional fisheries in the LOF to more accurately reflect the biology of marine mammals to facilitate establishing a standardized process for monitoring effort, estimating serious injury and incidental mortality, and evaluating the effectiveness of reduction efforts.

Response : NMFS addressed similar comments in the final LOF for 1997 (see Comment/Response 37 in 62 FR 33, January 2, 1997) and the final LOF for 1999 (see Comment/Response 18 in 64 FR 9067, February 24, 1999). In reviewing those actions, we determined that there was insufficient justification for a regional subdivision of the fishery. At this time, we are not aware of any new management efforts or changes in marine mammal take that would warrant a regional subdivision of the fishery.

Comment 17 : One commenter supported elevation of this fishery to Category II.

Response : Comment noted. NMFS agrees and is elevating this fishery to Category II in the 2001 LOF.

Comment 18 : One commenter opposed elevation of the Atlantic blue crab trap/pot fishery to Category II.

Response : Comment noted. NMFS disagrees and is elevating this fishery to Category II in the 2001 LOF.

Comment 19 : Three commenters opposed the implementation of the rule requiring Delaware crab licensees to register for marine mammal authorization, citing no known incident of marine mammals becoming entangled in crab pot gear in Delaware waters.

Response : Bottlenose dolphins are found in Delaware waters seasonally. NMFS is not aware of any evidence that either the crab pot fishery or the behavior of bottlenose dolphins in Delaware waters is different than in areas where takes have been documented or in a manner such that entanglement is not likely to occur. Since the distribution of the species overlaps the distribution of the fishery, there is a potential for incidental take. Therefore, inclusion of Delaware waters in the fishery listing is warranted. Also see response to Comment 2 for information on registration.

Comment 20 : One commenter recommended that the issue of potential threats of this fishery to bottlenose dolphin be referred to the Bottlenose Dolphin Take Reduction Team.

Response : It is not the role of take reduction teams to decide what data are appropriate for inclusion in the LOF. The determination of data to use in the LOF is made by NMFS with advice from the Scientific Review Groups through the SAR process, to which the public can also provide input. The role of any take reduction team is to make recommendations on reducing the serious injury and mortality of marine mammals incidental to the various fisheries in which the impacts have been documented. However, NMFS will present data on this fishery to the take reduction team, and the take reduction team will have opportunity to review the data and provide comments on how it is collected, analyzed, and interpreted.

Comment 21 : One commenter stated that in spite of the large number of blue crab trap/pots that are in use in North Carolina, this gear poses minimum threat to bottlenose dolphin because of the low number of documented interactions.

Response : The level of risk is determined relative to the PBR of the marine mammal stock in question, not relative to the size of the fishery. In addition, the threat of any one fishery must be viewed in the context of takes from all fisheries known to cause serious injury/mortality. For stocks with low PBRs, even rare interactions can represent a significant threat of serious injury/mortality relative to PBR. Between 1994 and 1998, 22 bottlenose dolphin carcasses (4.4 dolphins per year on average) recovered by the Stranding Network between North Carolina and Florida’s Atlantic coast displayed evidence of possible interaction with a trap/pot fishery (i.e., rope and/or pots attached, or rope marks). Data for states from Virginia north have not yet been examined in this context, but may include additional animals. Given that other sources of annual serious injury and mortality estimates (e.g., observer data) related to the Atlantic Blue Crab Trap/Pot Fishery are unavailable, the stranding data were used as a minimum estimate of annual serious injury and mortality. Although the probability of a single blue crab trap/pot interacting with a bottlenose dolphin may be small, the large amount of gear and the evidence provided from stranding data indicate that there is an occasional likelihood of serious injury or mortality to bottlenose dolphin from blue crab trap/pot gear.

Comment 22 : One commenter stated that the description of the geographic range of the Atlantic blue crab trap/pot fishery is incorrect. It is not possible for an area to lie north of 72°30′ W longitude, the description does not clearly identify whether or not internal State waters are included in the geographic range of the fishery, and the offshore boundary of the range of the fishery is not identified. If the offshore boundary is intended to be 72°30′ W, it far exceeds the geographic range of the fishery since blue crab trap/pots are primarily fished in coastal waters.

Atlantic tunas are managed under the dual authority of the Magnuson-Stevens Act and ATCA. ATCA authorizes the Secretary of Commerce (Secretary) to implement binding recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT). The authority to issue regulations under the Magnuson-Stevens Act and ATCA has been delegated from the Secretary to the Assistant Administrator for Fisheries, NOAA (AA).

Background information about the need for revisions to the HMS regulations was provided in the preamble to the proposed rule (65 FR 76601, December 7, 2000), and is not repeated here. By this final rule, NMFS implements mandatory dealer reporting of all purchases of Atlantic BAYS tunas; adjusts the north-south dividing line for the BFT Angling category subdivisions; adjusts associated subquota percentages allocated to each area; modifies regulatory text to clarify the requirement that imports, exports, and re-exports of bluefin tuna (both Atlantic and Pacific subspecies) be accompanied by a BSD; and modifies regulatory text to facilitate enforcement of, and compliance with, the regulations. Specifically, to facilitate enforcement of and compliance with the regulations, this rule requires that, for trailered vessels, BFT be tagged immediately upon the vessel being removed from the water; it specifies the existing size limit for swordfish in terms of Lower Jaw Fork Length (LJFL); and it modifies the vessel identification regulations to make them consistent with other Federal fisheries regulations. This rule also restores a prohibition on assaulting or impeding NMFS employees or contractors collecting scientific or management information on Atlantic HMS that was inadvertently omitted when the HMS regulations were consolidated under 50 CFR part 635 (64 FR 29090, May 28, 1999). Finally, this rule modifies the recently published final initial 2001 BFT quota specifications per the adjustments made to the BFT Angling category north-south division line and subquota allocations.

In the proposed rule that published on December 7, 2000, NMFS proposed removing the term “high flyer” from the definition of pelagic longline gear. This change to the regulations has already been implemented by an interim final rule published in the Federal Register on March 30, 2001 (66 FR 17370), and is no longer included as part of this rule.

Additionally, over the last several months, NMFS has received comments from the United States Coast Guard and vessel operators that the vessel identification requirements in the HMS regulations are inconsistent with the regulations for other federal fisheries on the East coast and Gulf of Mexico. Specifically, the HMS regulations require a vessel to display its vessel number in 10 inch (25.4 cm) block numerals for all vessels 65 ft (19.8 m) or less in length, while other NMFS regulations require 10 inch (25.4 cm) block numerals for vessels up to 65 ft (19.8 m) in length, but only for vessels greater than 25 ft (7.6 m) in length. For vessels 25 ft (7.6 m) in length or less, other NMFS regulations require 3 inch (7.6 cm) block numerals, or none at all. This inconsistency in the vessel identification regulations has made it difficult for the Coast Guard to enforce the regulations. In addition, it is difficult for a vessel less than 25 ft (7.6 m) in length to affix and display 10 inch (25.4 cm) block numerals. This final rule amends the HMS vessel identification regulations to make them consistent with those for other Atlantic and Gulf of Mexico species, requiring 3 inch (7.6 cm) block numerals for vessels less than 25 ft (7.6 m) in length, and, to be consistent with the terms of approval of this information collection, clarifies that the HMS vessel identification regulations do not apply to vessels with Atlantic tunas Angling category permits.

As this rule adjusts the BFT Angling category north-south division line and subquota allocations, adjustments to the recently published final initial 2001 BFT quota specifications must be made to reflect these changes. This final rule adjusts the 2001 BFT Angling category quota, subdividing the 2001 BFT Angling category quota of 609.3 metric tons (mt) as follows: School BFT—247.8 mt, with 127.0 mt to the northern area (north of 39°18′ N. latitude), 120.8 mt to the southern area (south of 38°47′ N. latitude), plus 20.6 mt held in reserve; large school/small medium BFT—330.0 mt, with 162.3 mt to the northern area and 167.7 mt to the southern area; and large medium/giant BFT—10.9 mt, with 4.8 mt to the northern area and 6.1 mt to the southern area.

There have also been several wording changes made to the regulatory text in the proposed rule, and two prohibitions were modified and one was added. These changes were made to clarify the intent of the regulatory text and to facilitate enforcement of the regulations.

NMFS conducted two public hearings on the proposed rule and received written and oral comments over a 60-day comment period. The vast majority of the comments received were in support of the proposed rule. Responses to specific comments on the issues contained in the proposed rule are provided here.

Comment: Most comments NMFS received were supportive of the BAYS tunas dealer reporting, stating that the reporting requirement could help collect tuna landings data that are currently unreported under the current regulations. One commenter stated that the revision to the regulations could result in the capture of data regarding landings of BAYS tunas that are sold unlawfully by non-permitted fishermen. One commenter stated that the regulatory amendment needed to go further, requiring a cross-referenceable report from harvesters (vessels).

Response: NMFS agrees that the proposed BAYS tunas dealer reporting requirements could help collect information regarding tuna landings that are currently unreported. Regarding vessel reporting, the HMS regulations give NMFS the authority to issue logbooks and to collect logbook information from all vessels with permits in the Atlantic HMS fisheries. Currently, only vessels with Atlantic swordfish and shark permits (including all vessels with Atlantic tunas Longline category permits) are currently selected to submit logbooks. NMFS agrees that additional vessel reporting may provide additional information and is investigating various kinds of logbook programs for all permitted HMS vessels.

Comment: Adoption of the proposed north-south dividing line change and quota subdivision would allow NMFS to manage the Angling category BFT season better, and would fix the unfair situation for vessels from Cape May, NJ, which, because they fish and land in two separate zones, were held to the more restrictive retention limit of the two fishing zones.

Response: NMFS agrees that the north-south dividing line change is appropriate. A goal of the proposed line change and the corresponding quota re-allocation is to minimize the number of cases where anglers are fishing in one zone and landing their fish in another.

Comment: NMFS should revise the BSD regulations to allow copies (instead of the original) of the original BSD be submitted to NMFS under certain circumstances, e.g., when a shipment comes into the United States with several bluefin, and a part of the shipment is re-exported while the rest remains in the United States for domestic consumption. Currently, the regulations require that the original BSD accompany the shipment and, in the case of imports, that the original BSD be submitted to NMFS. In the situation described above, it is not possible to submit an original BSD to NMFS for the domestically consumed fish and at the same time re-export part of the shipment also with an original BSD.

Response: NMFS regulations regarding BSD reporting are not under revision at this time, although NMFS recognizes the difficulty of complying with the current BSD reporting requirements in situations such as “split shipments”, where part of an imported shipment is then re-exported, or a shipment is re-exported to two different countries. NMFS will continue to work with bluefin importers and exporters to find solutions to these situations as they arise. In addition, ICCAT recently recommended the development of statistical document programs for swordfish and bigeye tuna. During the development of these programs, NMFS also plans to address these “split shipment” paperwork/reporting requirements in a comprehensive manner as part of an effort to harmonize the various reporting programs and forms involved in the tracking of trade in highly migratory species.

The only comments received on the proposed measures to facilitate enforcement and compliance were those of general support. NMFS finalizes these measures without revision.

This regulatory amendment is published under the authority of the Magnuson-Stevens Act, 16 U.S.C. 1801 et seq. , and ATCA, 16 U.S.C. 971 et seq. The AA has determined that the regulations contained in the regulatory amendment are consistent with the Magnuson-Stevens Act, ATCA, and the HMS FMP.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration when this rule was proposed, that if adopted as proposed, it would not have a significant economic impact on a substantial number of small entities. No comments were received that would alter the basis for this determination. Given the certification, neither an Initial nor Final Regulatory Flexibility Analysis was prepared.

This regulatory amendment has been determined to be not significant for purposes of Executive Order 12866.

The regulations implemented through this final rule are not expected to increase endangered species or marine mammal interaction rates. On June 8, 2001, NMFS issued a Biological Opinion (BO) after concluding formal consultation for the HMS fisheries under section 7 of the Endangered Species Act. The BO concluded that the pelagic longline fishery is likely to jeopardize the continued existence of threatened or endangered species. This final rule will not change fishing practices for longline vessels. NMFS plans on addressing the conclusions of the BO regarding the pelagic longline fishery through separate rulemaking. This final rule will not significantly alter current fishing practices and would not likely increase takes of listed species or interfere with the implementation of the reasonable and prudent alternative measures identified in the BO to reduce adverse impacts on protected resources.

The area affected by this final action has been identified as essential fish habitat (EFH) for species managed by the New England Fishery Management Council, the Mid-Atlantic Fishery Management Council, the South Atlantic Fishery Management Council, the Gulf of Mexico Fishery Management Council, the Caribbean Fishery Management Council, and the HMS Management Division of NMFS. It is not anticipated that this action will have any adverse impacts on EFH, and, therefore, no consultation is required.

This final rule contains a new collection-of-information requirement and restates several existing reporting requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). On March 29, 2001, OMB approved the collection-of-information requirement as a revision to the collection previously approved under OMB control number 0648-0013. The new requirement approved by OMB is an extension of dealer reporting requirements to Atlantic tunas, with an estimated public reporting burden of 12 minutes per response for dealers who would otherwise have been required to file a negative report (if permitted for swordfish or shark), 15 minutes for other dealers reporting purchases, and three minutes for other dealers to file.

This rule also restates a number of collection-of- information requirements that have been approved by OMB. These requirements and their OMB control numbers and estimated response times are: swordfish and shark dealer reports (15 minutes; 0648-0013); negative reports by swordfish and shark dealers (three minutes; 0648-0013); swordfish import dealer reports (15 minutes; 0648-0363) and swordfish certificates of eligibility (one hour; 0648-0363); bluefin tuna landing reports (two minutes; 0648-0239); bluefin tuna bi-weekly dealer report (15 minutes; 0648-0239); affixing tags to bluefin tunas and transferring tag numbers to documents (ten minutes; 0648-0239); vessel identification requirements (45 minutes; 0648-0373). All estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Any comments regarding burden-hour estimates for collection-of-information requirements contained in this final rule should be sent to (see ADDRESSES ).

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any 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.

This rule modifies the regulations at 50 CFR 635.6 on vessel identification, and at 50 CFR 635.71(b) on prohibitions on failing to report a BFT. These changes were not included in the proposed rule. The modifications to 50 CFR 635.6 (with respect to vessel identification) are needed to achieve consistency with other NMFS vessel marking regulations and relieve vessels fishing in HMS and other fisheries from the burden of having to comply with two different sets of marking requirements. Therefore, providing prior notice and an opportunity for public comment would serve no useful purpose. The modifications to 50 CFR 635.71 that clarify the existing prohibitions related to reporting a BFT, correct a cross-reference to the relevant reporting requirements, and clarify when BFT must be tagged and reported if they are in a trailered vessel, are needed to facilitate enforcement and ensure compliance with existing regulations. Delaying these clarifications to provide an opportunity for public comment would confound enforcement efforts and would serve no useful purpose. Accordingly, the AA finds good cause to waive the Administrative Procedures Act requirement to provide prior notice and the opportunity for public comment, pursuant to authority set forth at 5 U.S.C. 553(b)(B), as such procedures would be unnecessary or would be contrary to the public interest, as applicable.

Fisheries, Fishing, Fishing vessels, Foreign relations, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Statistics, Treaties.

Regulations implemented under the authority of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Conservation and Management 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.

A recommendation of the International Commission for the Conservation of Atlantic Tunas (ICCAT) allocates western Atlantic BFT catch quotas to contracting parties. The recommendation also requires that the United States limit the catch of school size BFT to no more than 8 percent by weight of the total domestic landings quota over each 4-consecutive-year period. NMFS implements this ICCAT recommendation through annual quota specifications, annual and inseason adjustments to the school BFT retention limits, as necessary, and by reserving a portion of the school BFT quota (64 FR 29090, May 28, 1999; 64 FR 29806, June 3, 1999).