A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that is applicable to Honeywell International Inc. (formerly AlliedSignal) Model RE220 (RJ) auxiliary power units was published in the Federal Register on January 30, 2003. That action proposed to require replacing the existing fuel nozzles, P/N WE3830486-2, with new design fuel nozzles, P/N WE3830513-1, making reidentification updates to the APU identification plate, and operating the APU to perform a visual inspection for fuel leaks. The FAA also published a related AD, AD 2002-26-07, in the Federal Register on January 2, 2003, for Bombardier model CL-600-2C10 airplanes. That AD limits P/N WE3800770-2 APUs that have the old design fuel nozzles to ground operation only, until the new fuel nozzles are installed.

Interested persons have been afforded an opportunity to participate in the making of this amendment. One commenter approves of the proposal as-written. No comments were received on the the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that is applicable to RR RB211 Trent 875-17, Trent 877-17, Trent 884-17, Trent 892-17, Trent 892B-17, and Trent 895-17 turbofan engines with HP compressor rotor rear stage 5 and 6 discs and cone shafts, part numbers (P/Ns) FK25230 and FK27899 installed was published in the Federal Register on March 11, 2003. That action proposed to require removal from service of these HP compressor rotor rear stage 5 and 6 discs and cone shafts, before reaching newly reduced life limits. Information on the reduced life limits of these HP compressor rotors may be found in RR mandatory service bulletin (MSB) RB.211-72-E082, Revision 2, dated November 22, 2002.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter requests that a reference to RR MSB RB.211-72-E082, Revision 2, dated November 22, 2002, be included in the final rule. The commenter believes that the reference to the MSB is necessary for clarification and for traceability to the AD if future revisions to the MSB are issued.

The FAA agrees. The MSB reference is included in the Supplementary Information paragraph and in Compliance paragraph (a).

One commenter states that the new life limit specified in the AD has already been included in the RB211 Trent Time Limits Manual (Chapter 5); therefore, the AD is unnecessary.

The FAA does not agree. Although the new life limits have been included in the RB211 Time Limits Manual, the reduced life limits are not enforceable unless mandated by an AD. Accordingly, the FAA will not change the AD based on this comment.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest the adoption of the rule with the change described previously. The FAA has determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

For the reasons discussed above, I certify that this action: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

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

The President issued Executive Order 12918 (May 26, 1994) implementing United Nations Security Council Resolution 918 (May 17, 1994). Due to the civil strife in Rwanda, Resolution 918 called upon all States to impose an embargo upon Rwanda. Consequently, all licenses and other approvals authorizing the export or transfer of defense articles or services to Rwanda were suspended, and a denial policy was imposed upon all new applications or other requests for such exports or transfers to Rwanda by Federal Register notice of June 2, 1994. Effective August 17, 1994, section 126.1 of the ITAR was amended to add Rwanda to the exemplary list of embargoed countries.

United Nations Security Council Resolution 1011 (August 16, 1995) lifted the arms embargo only with respect to the Government of Rwanda. That Resolution retained the restriction that all States “* * * continue to prevent” transfers of “arms and related materiel of all types * * * to Rwanda, or to persons in the States neighboring Rwanda if such sale or supply is for the purpose of the use of such arms or materiel within Rwanda, other than to the Government of Rwanda * * *.”

Accordingly, the policy of denial will remain in place for exports or other transfers of defense articles and defense services covered by section 38 of the Arms Export Control Act for use or originating in Rwanda other than by the Government of Rwanda. This action precludes the use in connection with non-governmental end-users in Rwanda of any exemptions from licensing or other approval requirements. Also, arms exports and transfers to or imports from Rwanda or neighboring States for use by the Government of Rwanda will continue to receive strict case-by-case review.

To implement United Nations Security Council Resolution 1011, section 126.1(a) of the ITAR is amended and section 126.1(h) is added to set forth the policy of denial with respect to Rwanda except for the Government of Rwanda.

This amendment involves a foreign affairs function of the United States and therefore, is not subject to the procedures required by 5 U.S.C. 553 and 554. It is exempt from review under Executive Order 12866 but has been reviewed internally by the Department to ensure consistency with the purposes thereof. This rule does not require analysis under the Regulatory Flexibility Act or the Unfunded Mandates Reform Act. It has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Act of 1966. It will not have substantial direct effects on the States, the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant application of Executive Orders 12372 and 13123. Interested parties are invited to submit written comments to the Department of State, Directorate of Defense Trade Controls, Office of Defense Trade Controls Management, ATTN: Regulatory Change, Rwanda embargo, 12th Floor, SA-1, Washington, DC 20522-0112.

The authority to issue this rule is vested in the Secretary of the Interior by 5 U.S.C. 301 and 25 U.S.C. 2 and 9; and 25 U.S.C. 13, which authorizes appropriations for “Indian judges.” See Tillett v. Hodel, 730 F. Supp. 381 (W.D. Okla. 1990), aff'd, 931 F.2d 636 (10th Cir. 1991) United States v. Clapox, 13 Sawy. 349, 35 F. 575 (D. Ore. 1888). This rule is published in exercise of the rulemaking authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs.

On September 18, 2001, the Bureau of Indian Affairs (BIA) published a temporary final rule (66 FR 48085) amending its regulations contained in 25 CFR part 11 to add the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony (Western Region, Nevada) to the list of Courts of Indian Offenses. This amendment established a Court of Indian Offenses for a period not to exceed one year. On September 24, 2002, the BIA published a final rule (67 FR 59781) establishing the Court of Indian Offenses for an indefinite period. The purpose of establishing a Court of Indian Offenses at the Fallon Reservation and Colony was to protect persons, land, lives and property of people residing there until the tribe reassumed its Law and Order program. The tribe has reassumed the tribal court function and notified the BIA by Tribal Resolution No. 03-F-054 that it is operating the court in accordance with its Constitution, Article VI, Section 1(h), and requested the removal of their listing from 25 CFR 11.100(a).

In accordance with the requirements of the Administrative Procedure Act (5 U.S.C. 553(B)), we have determined that publishing a proposed rule would be impractical because of the risk to public safety as well as further risk of exposure of the Federal Government to a lawsuit for failure to execute diligently its trust responsibility and to provide adequate judicial services for law enforcement on trust land. For this reason, an immediate effective date is in the public interest and in the interest of the tribe not to delay implementation of this amendment. We are therefore publishing this change as a final rule with request for comments.

BIA has determined it appropriate to make the rule effective immediately by waiving the 5 U.S.C. 553(d) requirement of publication 30 days in advance of the effective date. This is because of the critical need to ensure that uninterrupted court services are provided at the Fallon Reservation and Colony. Therefore, this final rule is effective immediately.

We invite comments on any aspect of this rule and we will revise the rule if comments warrant. Send comments on this rule to the address in the ADDRESSES section.

In accordance with the criteria in Executive Order 12866, this rule is not a significant regulatory action. OMB makes the final determination under Executive Order 12866.

(a) This rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. A cost-benefit and economic analysis is not required. The operational cost of the tribal court is estimated to be less than $200,000 annually. The cost associated with the operation of this court will be with the Bureau of Indian Affairs and the tribe.

(b) This rule will not create inconsistencies with other agencies' actions. The Department of the Interior, through the Bureau of Indian Affairs, has responsibility and authority to ensure that there are judicial systems in place on Indian reservations to protect persons, land, lives and property of people residing there.

(c) This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. This tribal court will not affect any program rights of the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony. Its primary function will be to administer justice for people within the tribe's reservation and colony.

(d) This rule will not raise novel legal or policy issues. Tribal governments have inherent sovereign authority to establish their own form of government, including tribal justice systems (25 U.S.C. 3601).

The Department of the Interior, BIA, certifies that this rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). An initial Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. The amendment to 25 CFR 11.100(a) removes the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony (Western Region, Nevada) from the listing of Courts of Indian Offenses. Accordingly, there will be no impact on any small entities.

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 or more. This court's operating cost is estimated to be less than $200,000 annually. The cost associated with the operation of this court will be with the BIA and the tribe.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. This is a court established specifically for the administration of justice for people located within the exterior boundaries of the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony and will not have any cost or price impact on any other entities in the geographical region.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises. This is a court established specifically for the administration of justice for people located within the exterior boundaries of the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony, Fallon, Nevada, and will not have an adverse impact on competition, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

(a) This rule will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is not required. The tribal court will not have jurisdiction to affect any rights of small governments. Its primary function will be to administer justice for people within the Fallon Indian Reservation and Colony.

(b) This rule will not produce a Federal mandate of $100 million or greater in any year; i.e. , it is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

In accordance with Executive Order 12630, this rule does not have significant takings implications. A takings implication assessment is not required. The amendment to 25 CFR 11.100(a) will provide for a tribal justice system with jurisdiction over people within a limited geographical area at Fallon, Nevada. Accordingly, there will be no jurisdictional basis for the tribal court to affect adversely any property interest outside of its jurisdiction.

In accordance with Executive Order 13132, this rule does not have significant Federalism effects. A Federalism assessment is not required. This rule concerns the recognition by the Federal Government of a tribe's inherent authority to establish their own justice systems and does not infringe on states' judicial systems. If the tribe chooses, they can establish their own judicial system apart from any State or local government in accordance with 25 CFR 11.100(c). The Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony (Western Region, Nevada) is acting under the purview of this provision in reassuming the judicial function on their reservation.

In accordance with Executive Order 12988, it has been determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. Congress, through statutes, treaties, and the exercise of administrative authorities, has recognized the self-determination, self-reliance, and inherent sovereignty of Indian tribes to establish their own form of government, including tribal justice systems (25 U.S.C. 3601).

This regulation does not require an information collection under the Paperwork Reduction Act. The information collection is not covered by an existing OMB approval. An OMB form 83-I has not been prepared and has not been approved by the Office of Policy Analysis. No information is being collected as a result of this court exercising its limited jurisdiction over people within the exterior boundaries of the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony.

We have analyzed this rule in accordance with the criteria of the National Environmental Policy Act and 516 DM. This rule does not constitute a major Federal action significantly affecting the quality of the human environment. An environmental impact statement/assessment is not required. This tribal court exercises jurisdiction over people within the exterior boundaries of the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony and does not have any impact on the environment.

Pursuant to Executive Order 13175 of November 6, 2000, “Consultation and Coordination with Indian Tribal Governments,” we have evaluated potential effects on federally recognized Indian tribes and have determined that there are no potential effects. The amendment to 25 CFR 11.100(a) does not apply to any of the 562 federally recognized tribes, except the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony. The tribe is exercising its inherent sovereignty by providing a judicial system for people within the exterior boundaries of the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony. The Department of the Interior is fulfilling its trust responsibility and complying with the unique government-to-government relationship that exists between the Federal Government and Indian tribes by assisting the Paiute-Shoshone Indian Tribe of the Fallon Reservation and Colony to support this justice system.

The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-1583. Responses to this collection of information are required to obtain the benefit of avoiding entering into a closing agreement with the IRS.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget.

The estimated annual burden per recordkeeper varies from 1 to 3 hours, depending on individual circumstances, with an estimated average of 2 hours.

Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be sent to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, W:CAR:MP:T:T:SP, Washington, DC 20224, and to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503.

Books or records relating to a collection of information must be retained as long as their contents might become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

Final regulations implementing section 1503(d) were adopted by TD 8434 (1992-C.B. 240), on September 9, 1992, and published in the Federal Register at 57 FR 41079 (REG-106879-00). On August 1, 2002, proposed regulations amending the final regulations, to reduce administrative burdens in certain cases, were published in the Federal Register at 67 FR 49892. Three written comments were received. No public hearing was requested or held. After consideration of the comments, these final regulations are adopted by this Treasury decision. The changes and clarifications made in the final regulations in response to the comments received are discussed below.

Section 1503(d) generally provides that a “dual consolidated loss” of a domestic corporation cannot offset the taxable income of any other member of the corporation's consolidated group. The statute, however, authorizes the issuance of regulations permitting the use of a dual consolidated loss to offset the income of a domestic affiliate if the loss does not offset the income of a foreign corporation under foreign law.

Section 1.1503-2(g)(2)(i) currently permits a taxpayer to elect to use a dual consolidated loss of a dual resident corporation or separate unit to offset the income of a domestic affiliate by filing an agreement ((g)(2)(i) agreement) under which the taxpayer certifies that the dual consolidated loss has not been, and will not be, used to offset the income of another person under the laws of a foreign country. Section 1.1503-2(g)(2)(iii) provides that, in the year of a “triggering event,” the taxpayer must recapture and report as gross income the amount of a dual consolidated loss that is subject to the (g)(2)(i) agreement and must pay the interest charge required by paragraph (g)(2)(vii). Section 1.1503-2(g)(2)(iv)(B), however, provides that specified acquisitions are not considered to be triggering events if certain conditions are satisfied. In particular, the parties to the acquisition must enter into a closing agreement with the IRS under section 7121, and the acquiring corporation or consolidated group must file a new (g)(2)(i) agreement with

The proposed regulations provided that a triggering event generally does not occur in two types of acquisitions, without any requirement to enter into a closing agreement or file a new (g)(2)(i) agreement: (1) When an unaffiliated dual resident corporation or unaffiliated domestic owner that filed a (g)(2)(i) agreement becomes a member of a consolidated group; and (2) when a dual resident corporation, or domestic owner, that is a member of a consolidated group that filed a (g)(2)(i) agreement (the acquired group) becomes a member of another consolidated group (the acquiring group) in an acquisition, so long as each member of the acquired group that is an includible corporation under section 1504(b) is included immediately after the acquisition in a consolidated U.S. income tax return filed by the acquiring group. Instead, in such cases, the proposed regulations required the filing of an information statement, whereby taxpayers would provide the IRS with most of the information that otherwise would have been provided in a new (g)(2)(i) agreement.

The proposed regulations were intended to relieve the burden of entering into a closing agreement in circumstances where the several liability imposed by § 1.1502-6, in combination with the original (g)(2)(i) agreement, would provide for liability by the acquiring group sufficiently comparable to that provided by a closing agreement. A commentator, who raised questions regarding comparable liability under § 1.1502-6 in such cases, in particular with respect to the interest charge, recommended that the regulations should retain the existing requirement for the acquiring corporation or consolidated group to enter into a new (g)(2)(i) agreement with respect to the dual consolidated loss. Although the IRS and Treasury believe that § 1.1502-6 provides an independent assurance of several liability, the recommendation to retain the existing requirement for a new (g)(2)(i) agreement has been adopted in these final regulations. The IRS and Treasury have concluded that the intended reduction in administrative burden can be accomplished through the elimination of the requirement to enter into a closing agreement in the cases specified in the proposed regulations. Moreover, with the retention of the requirement to file a new (g)(2)(i) agreement, the requirement in the proposed regulations to file a separate information statement containing essentially the same information has been eliminated. Additional changes have been made to clarify the nature of the new (g)(2)(i) agreement.

The commentators also suggested that any affiliated dual resident corporation or affiliated domestic owner should be permitted to join the acquiring group without causing a triggering event, regardless of whether all members of the consolidated group that filed the original (g)(2)(i) agreement also join the acquiring group, provided that the acquiring group files a new (g)(2)(i) agreement. This suggestion has not been adopted in these final regulations. The final regulations contain a modified description of the types of transactions for which a closing agreement no longer is required, to make clear that all members of an acquired group (or their successors-in-interest) must be members of the acquiring group immediately after the acquisition ( i.e. , that no member of the acquired group, or its successor-in-interest, is excluded from the acquiring group due to any applicable restriction such as section 1504(a)(3) or section 1504(c)). However, the IRS and Treasury are continuing to consider this suggestion as well as other alternatives for further reducing the administrative and compliance burdens under the section 1503(d) regulations, and invite additional comments in this regard.

In order to accomplish the intended reduction in administrative burdens promptly, the final regulations are applicable with respect to transactions otherwise constituting triggering events occurring on or after January 1, 2002.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that these regulations do not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that these regulations will primarily affect affiliated groups of corporations that also have a foreign affiliate, which tend to be larger businesses. Moreover, the number of taxpayers affected and the average burden are minimal. Therefore, a Regulatory Flexibility Analysis is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the proposed regulations preceding these regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

The principal authors of these regulations are Kenneth D. Allison and Kathryn T. Holman of the Office of Associate Chief Counsel (International). However, other personnel from the IRS and Treasury Department participated in their development.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Publishing a NPRM and delaying its effective date would be contrary to public interest because immediate action is needed to protect vessels and mariners from the hazards associated with construction operations on the Cape Girardeau Bridge.

The Captain of the Port Paducah is establishing a temporary safety zone for all waters of the Upper Mississippi River from mile marker 51.5 to 52.5 near Cape Girardeau, MO. This safety zone is needed to protect vessels and mariners from the safety hazards associated with the construction operations on the Cape Girardeau Bridge. Construction operations have been ongoing for several months with an average of one closure a week. Scheduled meetings between the contractor, industry, the Eighth Coast Guard District Bridge Branch and the Captain of the Port Paducah led to a defined process for scheduling multiple closures a week from July 13, 2003 through August 15, 2003. All closures shall be limited to one 9-hour period, typically from 8 a.m. to 5 p.m. Entry into this zone is prohibited to all vessels unless authorized by the Coast Guard Captain of the Port Paducah or a designated representative.

The Captain of the Port Paducah will announce enforcement periods via marine information broadcasts.

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 Homeland Security (DHS).

This rule will only be in effect for a short period of time and notifications to the marine community will be made through broadcast notice to mariners. The impacts on routine navigation are expected to be minimal as the zone will only be enforced for a nine-hour period three days a week.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the Upper Mississippi River, from Mile Marker 51.5 to 52.5 from 8 a.m. through 5 p.m. up to three days a week from July 13, 2003 through August 15, 2003. This safety zone will not have a significant economic impact on a substantial number of small entities because this rule will be in effect for only a short period of time.

If you are a small business entity and are significantly affected by this regulation please contact, LTJG Patrick Mounsey, Marine Safety Office Paducah representative, at (270) 442-1621 ext. 350.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so they could better evaluate its effects on them and participate in the rulemaking process. 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, call1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES.

I. General Information A. What Are the Regulated Entities?

Entities potentially affected by the subject rule for today's action include sources in all industry groups. The majority of sources potentially affected are expected to be in the following groups.

Entities potentially affected by the subject rule for today's action also include State, local, and tribal governments that are delegated authority to implement these regulations.

1. Docket. EPA has established an official public docket for this action under E-Docket ID No. OAR-2001-0004 (Legacy Docket ID No. A-90-37). The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, (Air Docket), U.S. Environmental Protection Agency, 1301 Constitution Ave., NW., Room: B108, Mail Code: 6102T, Washington, DC, 20460. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1742. A reasonable fee may be charged for copying.

2. Electronic Access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ .

An electronic version of a portion of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. Interested persons may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket identification number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in section I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

For additional information about EPA's electronic public docket visit EPA Dockets online or see 67 FR 38102, May 31, 2002.

You may submit comments electronically, by mail, by facsimile, through hand delivery/courier, or by phone. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in section I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically . If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

a. EPA Dockets . Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket , and follow the online instructions for submitting comments. To access EPA's electronic public docket from the EPA Internet Home Page, select “Information Sources,” “Dockets,” and “EPA Dockets.” Once in the system, select “search,” and then key in either Docket ID No. A-90-37 or E-Docket ID No. OAR-2001-0004 (for which A-90-37 is now a legacy number). The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

b. E-mail . Comments may be sent by electronic mail (e-mail) to a-and-r-docket@epamail.epa.gov , Attention E-Docket ID No. OAR-2001-0004 (Legacy Docket ID No. A-90-37). In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

c. Disk or CD ROM . You may submit comments on a disk or CD ROM that you mail to the mailing address identified in section I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By Mail . Send two copies of your comments to: U.S. Environmental Protection Agency, EPA West (Air Docket), 1200 Pennsylvania Ave., NW., Room: B108, Mail Code: 6102T, Washington, DC, 20460, Attention E-Docket ID No. OAR-2001-0004 (Legacy Docket ID No. A-90-37).

3. By Hand Delivery or Courier . Deliver your comments to: EPA Docket Center, (Air Docket), U.S. Environmental Protection Agency, 1301 Constitution Ave., NW., Room: B108, Mail Code: 6102T, Washington, DC, 20460, Attention Docket ID No. A-90-37. Such deliveries are only accepted during the Docket's normal hours of operation as identified in section I.B.1.

4. By Facsimile . Fax your comments to the EPA Docket Center at (202) 566-1741, Attention Docket ID No. A-2001-0004 (Legacy Docket ID No. A-90-37).

5. By Phone . You may call and leave oral comments on a public comment phone line. The number is (919) 541-0211. EPA will log and place in E-Docket ID No. OAR-2001-0004 (Legacy Docket ID No. A-90-37) any comments received through this phone number.

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. Send or deliver information identified as CBI only to the following address: Mr. David Svendsgaard, c/o OAQPS Document Control Officer (C339-03), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711, Attention E-Docket ID No. OAR-2001-0004 (Legacy Docket ID No. A-90-37). You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI. (If you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI.) Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.

You may find the following suggestions helpful for preparing your comments.

• Explain your views as clearly as possible.

• Describe any assumptions that you used.

• Provide any technical information and/or data you used that support your views.

• If you estimate potential burden or costs, explain how you arrived at your estimate.

• Provide specific examples to illustrate your concerns.

• Offer alternatives.

• Make sure to submit your comments by the comment period deadline identified.

• To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

The public hearing will provide interested parties the opportunity to present data, views, or arguments concerning the issues raised in this notice. Person interested in attending or presenting oral testimony are encouraged to register in advance by contacting Ms. Chandra Kennedy, OAQPS, Integrated Implementation Group, Information Transfer and Program Integration Division (C339-03), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number (919) 541-5319 or e-mail kennedy.chandra@epa.gov no later than August 11, 2003. Presentations will be limited to 5 minutes each. We will assign speaking times to speakers who make a timely request to speak at the hearing. We will notify speakers of their assigned times by August 13, 2003. We will attempt to accommodate all other persons who wish to speak, as time allows.

The EPA's planned seating arrangement for the hearing is theater style, with seating available on a first come first served basis for about 250 people. Attendees should note that the use of pickets or other signs will not be allowed on hotel property.

As of the date of this announcement, the Agency intends to proceed with the hearing as announced; however, unforeseen circumstances may result in a postponement. Therefore, members of the public who plan to attend the hearing are advised to contact Ms. Chandra Kennedy at the above referenced address to confirm the location and date of the hearing. You may also check our New Source Review Web site at http://www.epa.gov/nsr for any changes in the date or location.

The record for this action will remain open until September 15, 2003 to accommodate submittal of information related to the public hearing.

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

The information presented in this preamble is organized as follows:

In the early 1990's, the Environmental Protection Agency (“we” or “the Agency”) began an effort to revise the major NSR regulations to respond to concerns expressed by regulated industry and State and local permitting authorities that the major NSR regulations were too complex and burdensome. This effort involved the solicitation of ideas and recommendations from the Clean Air Act Advisory Committee and the public. The goal of this effort, known as NSR Reform (or NSR Improvement), was to eliminate as much of the program complexity, administrative burden and resultant project delays as possible without sacrificing the current level of environmental protection and benefits derived from the program.

On July 23, 1996 (61 FR 38250), we proposed changes to various aspects of the NSR program based primarily on consideration of recommendations provided through the NSR Reform effort, but also based on our own independent initiatives to further clarify the major NSR program. The proposed changes addressed baseline emission determinations, actual-to-future-actual emissions measurement methodology, Plantwide Applicability Limitations (PALs), Clean Units, and Pollution Control Projects (PCPs), as well as other changes.

Following the 1996 proposal, we held two public hearings and more than 50 stakeholder meetings. Environmental groups, industry, and State, local, and Federal agency representatives participated in these many discussions. We received several hundred public comments on the 1996 proposal rule. As a result of comments received and further review of the issues by the Agency, we sought further comment on some issues in the proposed rule. On July 24, 1998, we published a Federal Register Notice of Availability (NOA) that requested additional comment on three of the proposed changes— baseline emissions determination, the actual-to-future-actual-methodology, and PALs. We received several hundred public comments on the NOA. Following the NOA, we convened various stakeholder meetings concerning NSR Reform over a number of years. Information on these meetings can be found in Docket ID No. A-90-37.

On December 31, 2002, we issued a final rule (67 FR 80186) that revised regulations governing the major NSR programs (final rules). 1 The revisions included five major changes to the major NSR program that will reduce burden, maximize operating flexibility, improve environmental quality, provide additional certainty, and promote administrative efficiency. These elements include baseline actual emissions, actual-to-projected-actual emissions methodology, PALs, Clean Units, and PCPs. The final rules also codified our longstanding policy regarding the calculation of baseline emissions for electric utility steam generating units (EUSGUs). In addition, the final action: (1) Responded to comments we received on a proposal to adopt a methodology, developed by the American Chemistry Council (formerly known as the Chemical Manufacturers Association (CMA)) and other industry petitioners, to determine whether a major stationary source has undertaken a major modification based on its potential emissions; and (2) included a new section that spells out in one place how a major modification is determined under the various major NSR applicability options. This topic had previously been addressed primarily in the definition section of the major NSR regulations. We also clarified where to find the provisions in the revised rules and codified a definition of “regulated NSR pollutant” that clarifies which pollutants are regulated under the Act for purposes of major NSR.

On February 28, 2003, we sent notice to affected States that, consistent with our proposal in 1996, we were revising the references to 40 CFR 52.21 in delegated States' plans to reflect the December 31, 2002 changes to the Prevention of Significant Deterioration (PSD) Federal Implementation Plan (FIP) (40 CFR 52.21(a)(2) and (b) through (bb)). This FIP applies in any area that does not have an approved PSD program in the State Implementation Plan (SIP), and in all Indian country. The notice was subsequently published in the Federal Register on March 10, 2003 (68 FR 11316).

Following publication of the December 31, 2002 and March 10, 2003 Federal Register notices, the Administrator received numerous petitions, filed pursuant to section 307(d)(7)(B) of the CAA, requesting reconsideration of many aspects of the final rules. 2 The purpose of today's notice is to initiate a process for responding to several issues raised in these petitions.

At this time, we have decided to grant reconsideration on six issues raised by petitioners. 3 The first involves a document we released in November 2002, entitled, “Supplemental Analysis of the Environmental Impact of the 2002 Final NSR Improvement Rules.” 4 This analysis provides the Agency and other interested parties with additional information on the environmental effects of the final rules. The analysis shows that the final rules will result in greater emissions reductions than the former program. Petitioners assert that the final rules are flawed because we did not rely on this document in promulgating the rule and hence that we promulgated the final rule without having adequately evaluated its environmental impacts. In the alternative, they assert that, to the extent we relied on the analysis for that assessment, we did so improperly because we did not make the analysis available for public comment. Petitioners further assert that our analysis does not properly analyze the environmental effects of the rule and did not take into account recent information about the health impacts of air pollution and the effects of the final rule on air pollutant emissions. 5

We disagree with Petitioners' assertions. During the rulemaking process, we strived to take into consideration relevant and reliable information on environmental effects. We did in fact take account of environmental considerations in formulating the final rules, and believe the final rules are properly supported and justified in this regard. However, we want Petitioners and others to have every opportunity to comment on the work that we have done to date and to provide additional information that they believe to be relevant to the inquiry. For these reasons, we have chosen to grant the petitions as they relate to these issues. In short, we have no reason to believe our analysis of environmental effectiveness is incorrect or flawed. Nevertheless, we do think the supplemental analysis provides additional support for the final rules, so we are making it available for public comment, and we will reevaluate our conclusions in light of the comments and information submitted.

The remaining issues for which we grant reconsideration involve five narrow aspects of the final rule. For each of the five, Petitioners claim that the final provision did not sufficiently reflect the ideas set forth in the proposed rule and, therefore, that they did not have an adequate opportunity to provide input during the designated public comment period. Without prejudging the information that will be provided in response to this notice, we note that to date Petitioners have not provided information which persuades us that our final decisions are erroneous or inappropriate. While we do not agree with Petitioners' claim, we have decided to grant reconsideration on these issues in an interest of ensuring a full opportunity for comment. Each of these issues is described in detail below.

Our final decision on reconsideration for all the remaining issues in the petitions for reconsideration will be issued no later than the date by which we take final action on the issues for which we have decided to grant reconsideration. We plan to take final action on all issues no later than 90 days after publication of today's notice.

We are not granting a stay of the final rules pending our reconsideration of these issues. Under sections 307(b)(1) and 307(d)(7)(B) of the Act, the effectiveness of the final rules is not automatically postponed by our granting the petitions for reconsideration on certain issues. The Administrator (or the court), however, may stay the rules pending our reconsideration for a period not to exceed three months. 42 U.S.C. 7607(d)(7)(B). Petitioning States and Environmental Groups requested that we exercise our discretion under this section and grant a stay of the final rules during reconsideration. 6

We do not believe that a stay is warranted. We believe that the final rules are a reasonable exercise of our discretion under the CAA, and will result in greater emission reductions compared to the former program. 7 Moreover, although we have decided to reconsider certain aspects of the final rules, at this time we do not have reason to believe that the substantive decisions reflected in the final rule are erroneous. We are also concerned about the impact of a stay on facilities located in delegated States. The new requirements are currently in effect in these areas. We believe that it would be inappropriate to revert to the former program when it is likely that the current program would be reinstated 60 to 90 days later. Further, we do not believe our decision to deny a stay will have any significant effect on facilities subject to a SIP-approved major NSR program. We have provided these States up to three years to make appropriate changes to their SIP-approved programs. We intend to complete our reconsideration of the final rules regarding the issues discussed in this Federal Register notice quickly ( i.e. , in approximately 90 days), thus, any uncertainty regarding the final rules caused by our partial granting of the petitions for reconsideration will be for a short period. States will still have ample time after our final decision on reconsideration to revise their SIPs to implement the rule (and any changes resulting from our reconsideration). As a result, we do not think it would be appropriate to stay the effectiveness of the rule while we address a few issues raised in the petitions. 8

In November 2002, we released a document entitled, “Supplemental Analysis of the Environmental Impact of the 2002 Final NSR Improvement Rules.” As we noted at that time, the analysis was intended to provide the interested public with supplemental information on the potential environmental effects of the NSR Improvement rules that we were finalizing.

In the supplemental environmental analysis, we found that the overall effect of the final rule would be a net benefit to the environment compared to the former NSR rules because the final rule would result in reductions in emissions of air pollution. We found that four of the five provisions in the final rule would result in environmental benefits, and the other provision would have no significant effect. Specifically, for each of the rule's five provisions, the analysis concludes the following:

(1) The PAL provisions will result in tens of thousands of tons per year (tpy) of volatile organic compounds (VOC) reductions from just three industrial categories where PALs are likely to be used most often. Overall reductions will be greater because it is likely that PALs also will be adopted in other source categories.

(2) The Clean Unit Test will be environmentally neutral for most sources, but some sources will likely control emissions earlier or more extensively than under the former rules, and, as a result, a net benefit will occur. The amount of this benefit is uncertain nationally, but likely will be significant in individual cases, like the estimated 9,300 tpy reduction in smog-causing VOC seen in one example.

(3) The PCP Exclusion will lead to a small increase in the number of environmentally beneficial projects because it removes NSR barriers to such projects. The amount of this benefit is uncertain nationally, but will likely be relatively small.

(4) The portion of the rule addressing baseline actual emissions will not have a significant environmental impact. The former program already allowed sources to use a more representative baseline period, with the approval of the reviewing authority, instead of the two-year period before the change specifically delineated in the former rules. The final rules provide an expanded time frame from which you may select a representative baseline but eliminate the option of going beyond this period of time. While the new rules may allow a small number of existing emissions units to use higher baselines, other units will be required to use lower baselines due to the requirement to adjust the baseline downward to account for any new emission limitations at that emissions unit. The changes overall impact will be small because the portion of the rule addressing baseline actual emissions does not affect new sources, new units built at existing sources, electric utilities, and many modified sources.

(5) The change to the actual-to-projected-actual test will have a net environmental benefit, but a relatively small one. The benefit stems from removing: (1) Incentives to keep actual emissions high before making a change, and (2) barriers to projects that will reduce emissions. The size of this benefit nationally is uncertain. Its impact would be small because the change in emissions calculation methodology does not affect either of the following: (1) New sources, new units built at existing industrial facilities, and electric utilities, or (2) any modifications at existing facilities that actually result in significant increases in emissions. Historically, under the previous major NSR rule, virtually all other sources making a physical or operational change have accepted “permit limits” so as to be confident that they will not trigger major NSR. Our analysis concludes that the benefits from this aspect of the program are likewise largely unaffected because such sources must still assure that actual emissions do not significantly increase as a result of a change.

The supplemental environmental analysis uses quantitative information where possible but also notes limitations on our ability to quantify impacts of the rule. We used qualitative information to supplement the analysis when such limitations are present. We also noted that the final rules will result in economic benefits that stem from improved flexibility, increased certainty, and reduced administrative burden. These benefits are important, but were not quantified as part of this environmental analysis.

The analysis is available in the docket for today's action and is also available on the Internet at http://www.epa.gov/nsr. We request comment on all aspects of the environmental impact of the final rule.

The December 31, 2002 final major NSR rule included an innovative approach to managing major NSR applicability at major stationary sources based on actual plantwide annual emissions. Under these provisions, an owner or operator (you) of a major stationary source (source) may elect to establish a source-wide cap on emissions, known as a “plantwide applicability limitation” (PAL), based on your source's baseline actual emissions. As long as you do not exceed this “actuals PAL,” a significant emissions increase has not occurred. Without a significant emissions increase, no change at your facility is considered a major modification, and you are not subject to major NSR.

Today, we are soliciting comment on two aspects of the PAL final rules. These issues are discussed below.

In general, the PAL level is established as the sum of the baseline actual emissions of the PAL pollutant for each emissions unit at your major stationary source. The baseline period may be any consecutive 24-month period during the preceding 10 years, but you must use the same baseline period for all existing emissions units. However, the final rules contain special provisions for an emissions unit on which you began actual construction after the 24-month baseline period. The reviewing authority must use the potential to emit (PTE) of such emissions units in establishing the PAL. See 40 CFR 51.165(f)(6), 51.166(w)(6), 52.21(aa)(6). This provision is intended to serve as a counterpart to the requirement to exclude from the PAL level any emissions from emissions units that were permanently shut down after the baseline period.

We included these provisions in recognition that the set of emissions units at your source at the time of PAL permit issuance may be different from the set of emissions units that existed during the baseline period. You may have constructed additional emissions units, permanently shut down previously existing emissions units, or both. The actuals PAL rule is designed to ensure that the PAL level is adjusted to reflect the present-day configuration of emissions units at your source. Thus, it instructs the reviewing authority to exclude from the PAL level emissions from permanently shut down units and to add to the PAL level the PTE of emissions units on which you began actual construction after the baseline period.

We considered applying the procedures for determining baseline actual emissions at 40 CFR 51.165(a)(1)(xxxv), 51.166(b)(47), and 52.21(b)(48); however, under these procedures the baseline actual emissions of the existing emissions units on which you began actual construction after the selected baseline period would be zero. When these procedures are used for determining applicability of the major NSR requirements, we believe this is an appropriate outcome because such determinations ordinarily involve a limited set of emissions units (those that are part of a modification) at the major stationary source and issues related to start up and shutdown of emissions units are typically not implicated. You have the ability to choose the 24-month baseline period that accommodates the integrated operations of this limited set of emissions units. Moreover, the baseline actual emissions are only used as a measure to determine whether a project will trigger major NSR review. It is not used as an enforceable restriction on the ability of the emissions units to operate.

In contrast, setting a PAL involves all of the emissions units at the major stationary source. Selecting a single 24-month period that accommodates the integrated operations of all of these emissions units is more difficult and will often involve emission units that start up or shut down after the baseline period. Moreover, establishing a baseline actual emissions of zero is an unrealistic reflection of how the emissions unit will be operated and could require you to unreasonably restrict operations at the major stationary source to ensure you comply with the PAL.

We also considered but rejected several other approaches. First, we considered requiring you to use the immediately preceding 24 months to establish an average annual emissions rate for such emissions units, or requiring all existing emissions units to follow this approach. However, as discussed in the December 31, 2002 preamble (67 FR 80191), this approach does not account for normal fluctuations in operations and may not be representative of source operations.

We also considered making no adjustments for either shut down emissions units or newly constructed emissions units, but this approach seemed to be least representative of a major stationary source's current operations. And finally, we considered allowing you to select different 24-month periods for each existing emissions unit at the major stationary source or allowing you to select any 24-month period since operations began for the recently constructed emissions units.

We believe that the former approach would unnecessarily complicate the procedures for establishing PALs and allow you to inappropriately maximize source-wide emissions. The latter approach has some advantage in that it provides a measure of past emissions; however, we rejected this approach in favor of using the PTE of the emissions unit. This is because we believe that most emissions units that have been constructed after the baseline period are likely to have undergone major or minor NSR review. 9 Thus, the PTE of the emissions unit reflects requirements to comply with recent control technology requirements and other emission limitations that are representative of how you intend to actually operate the emissions unit. The past emissions of such emissions units, when measured over a shortened period of time, may not be representative of intended operations.

In view of all of these considerations, we believe that including the PTE of the emissions unit in the PAL baseline is the most appropriate measure of actual operations of such emissions units for the purpose of establishing an enforceable limitation on your operations. We believe such a provision falls within the discussion of PALs in the proposed rule. Nevertheless, we request comment on this approach, the approaches we rejected, and any other method for assessing emissions from these emissions units.

A synthetic minor limit is a limit that is included in a permit by a reviewing authority at the request of a source to reduce the potential to emit (PTE) of a facility or emissions unit below a level that would otherwise subject the facility or emissions unit to some regulatory requirement. Such limits are often used by a facility to reduce emissions below a level that would subject a project to the major NSR requirements. (They are also used for similar purposes under other regulatory programs.)

Under the major NSR program, we refer to these emission or operational limitations as (r)(4) limits because provisions relating to these types of restrictions are contained in paragraph (r)(4) of the Federal Prevention of Significant Deterioration (PSD) Program. See 40 CFR 52.21(r)(4). Similar provisions are contained in the requirements for State programs. See 40 CFR 52.165(a)(5)(ii), 51.166(r)(2).

In the December 31, 2002 final rule, we specified that a reviewing authority can eliminate (r)(4) limits for a PAL pollutant if you previously took these limits to avoid major NSR. In the absence of a PAL, relaxation of such limits would cause you to determine major NSR applicability as if construction had not yet commenced on the new or modified emissions units. See 40 CFR 52.165(a)(5)(ii), 51.166(r)(2), 52.21(r)(4). Under a PAL, such limits may be relaxed or removed without triggering major NSR for the PAL pollutant. 67 FR 80210; 40 CFR 165(f)(1)(iii)(C), 166(w)(1)(ii)(c), 52.21(aa)(1)(ii)(c). The (r)(4) limits do not reappear upon PAL expiration. 67 FR 80209; 40 CFR 51.165(f)(9)(v), 51.166(w)(9)(v), 52.21(aa)(9)(v). Instead, they are reapportioned, along with the PAL, among the existing emissions units. We believe the approach adopted in the final rules reflect the purpose of a PAL, which is to maximize operational flexibility without sacrificing environmental protection.

We view the PAL as the functional substitute for any unit-specific (r)(4) limits that you may have taken to reduce emissions below a level that would subject a project to major NSR requirements. Both the PAL and the (r)(4) limits serve to keep you from triggering major NSR. Emissions from emissions units with (r)(4) limits are incorporated into the PAL at a level that is at or, in most cases, below those limits. Therefore, the PAL is an effective substitute for those limits. More importantly, we believe that removal of these limits is essential to allow you to benefit from the operational flexibility and corresponding environmental benefits that the PAL is intended to provide.

We considered reinstating (r)(4) limits if a PAL expires. However, we rejected this approach because we recognize that you may have made changes to the emissions unit or associated operations, and it may not be practical to return the emissions unit to its pre-PAL operations. Instead, the final rules ensure that the (r)(4) limitations that are incorporated into the PAL continue to play a role after PAL expiration, although not in the same form.

Before a PAL expires, you must submit a proposal for distributing the PAL among individual emissions units or groups of emissions units. The reviewing authority will make the final decision on PAL emissions distribution. Following expiration, you must ensure that the individual emissions units or groups of emissions units comply with their limits as assigned by the reviewing authority. In this way, the emission restrictions associated with an (r)(4) limitation are accounted for after PAL expiration. However, the new emission limitation(s) would not be subject to the requirements of 40 CFR 52.21(r)(4).

We are proposing to retain our approach for removing and superseding (r)(4) limits with a PAL. We request comment on this approach.

In 1996, we proposed to allow use of the “future-actual methodology” to compute whether a physical change in or change in the method of operation of the major stationary source would result in a significant emissions increase. Previously, this methodology was only available to EUSGUs under the WEPCO rule. 10 Our 1996 notice proposed to extend a version of the WEPCO rule to all source categories. In that proposal, we sought comment on several issues including whether the 5-year reporting provision is working as intended and whether it should be changed in any way. We adopted a modified WEPCO approach in the final rules. We call this approach the “actual-to-projected-actual” applicability test. This test is similar to the WEPCO rule in that it allows you to consider “demand growth” in determining post-change emissions, but it contains recordkeeping and reporting requirements that differ from those in the WEPCO rule. 11 (There are other differences between the two approaches, but these differences are not relevant to the following discussions.)

Today, we are soliciting comments on an issue related to the recordkeeping and reporting requirements under the actual-to-projected-actual applicability test and on allowing replacement units to use the actual-to-projected-actual applicability test. These issues are discussed below.

As noted above, the recordkeeping and reporting requirements in the final rules differ from those in the WEPCO rule. The WEPCO rules required EUSGUs that relied on the actual-to-representative-future-actual-annual emissions test to submit annual emission reports. In contrast, the final rules require non-EUSGUs (that project future emissions rather than relying on potential emissions as a measure of future emissions) to: maintain certain records related to the emissions projection and records of the post-change emissions (for either 5 years or 10 years depending on the nature of the change); and report if there is a significant emission increase in post-change emissions which is inconsistent with the source's preconstruction projection. 12 For EUSGUs (that project future emissions rather than relying on potential emissions as a measure of future emissions), the final rules require you to send a copy of the information to the reviewing authority that you are required to keep relating to your projection. However, all of these reporting and recordkeeping requirements apply to non-EUSGUs and EUSGUs only if there is a “reasonable possibility” that the project will result in a significant emissions increase.

We included these changes to respond to comments we received in response to our request for comments on whether the 5-year reporting provisions of the WEPCO rule were working as intended and whether these requirements should be changed. Some commenters indicated that the 5-year recordkeeping and reporting requirements were onerous. Commenters also noted that the requirements were unnecessary because similar information is available through the title V permitting program and State emission inventories. Other commenters requested that we retain an option to use the actual-to-potential approach, which does not require recordkeeping or reporting. We retained that option within the actual-to-projected-actual applicability test.

In 1998, we solicited additional comment on an approach that would have required you to obtain a federally enforceable permit to limit your post-change emissions to your projected levels (the actual-to-future-enforceable-actual test), and again solicited comment on the appropriate recordkeeping and reporting requirements. In general, commenters were supportive of a 5-year recordkeeping requirement. Responses were mixed as to whether we should extend the requirement to 10 years if the permitting authority believed it appropriate. Again, we received comments that reporting and recordkeeping requirements were duplicative of those required by other programs. Also, we received comments from State agencies concerned with the resource burden that would be imposed by requirements of the actual-to-future-actual test.

In an effort to balance the need for information to determine compliance and the associated burden of recordkeeping and reporting, we finalized the changes to the proposed recordkeeping and reporting requirements. We included the “reasonable possibility” provision because we were concerned that without some qualifier on when you need to retain records and report, our rules would encompass any physical or operational change you undertake no matter how inconsequential and unlikely that an emissions increase would result.

We believe that, in some circumstances, the requirements to record and report emissions following completion of certain types of projects is a substantial strengthening over the former regulatory requirements that applied to non-EUSGUs. The former rules contained no reporting or recordkeeping requirements when you determined that major NSR did not apply. For example, the former rules allowed you to make your own determination as to whether major NSR applied to a project. If you determined that an emissions increase from a project was less than significant, you could proceed with the project, and there were no subsequent recordkeeping or reporting requirements under the major NSR program. The same result occurred if you determined your project would result in a significant emissions increase but you were able to “net” the project out of review. Under the revised rules, if you project future emissions rather than relying on potential emissions as a measure of future emissions, you (whether an EUSGU or non-EUSGU) are required to record and report any project for which you avoid the major NSR requirements through “netting,” because you will have already determined that such projects will result in a significant emissions increase.

We are proposing to retain the “reasonable possibility” requirement for triggering the applicability of the recordkeeping and reporting provisions discussed above. We believe these provisions are appropriate based on our proposal and the comments received thereon; nevertheless, we are requesting comment on this approach.

The WEPCO rule precluded use of the actual-to-representative-future-actual-annual emissions test for replacement units. See 40 CFR 52.21(b)(921)(v)(2002). Although the 1996 preamble recognized this preclusion in our discussion of extending the WEPCO rule to other industrial sectors, see 62 FR 38267, the proposed regulatory language removed the preclusion and would have allowed all emissions units (EUSGUs and non-EUSGUs), including replacement units, to use the actual-to-future-actual emissions test. See proposed 40 CFR 52.21(b)(21)(ii), 61 FR 38338.

In the final rules, we concluded we should not preclude use of the actual-to-projected-actual test either for EUSGUs or non-EUSGUs replacement units. We explained the basis for our conclusion in the final rule. See 67 FR 80194. Although we discussed this issue in the proposal, we are seeking comment on our determination on this issue and the basis for it set forth in the preamble to the final rules.

Our December 31, 2002 final rules finalize provisions that provide added flexibility to emissions units that install state-of-the-art emissions controls. Specifically, we promulgated a new type of major NSR applicability test for emissions units that are designated as Clean Units.

The Clean Unit applicability test (“Clean Unit Test”) measures whether an emissions increase occurs, based on whether a project affects the Clean Unit status of the emissions unit. The Clean Unit Test provides that when you meet emission limitations based on installing state-of-the-art emissions control technologies (add-on controls, pollution prevention, or work practices) that are determined to be BACT or LAER (or comparable to BACT or LAER), you may make any physical or operational change to the unit without triggering major NSR, provided that the change does not (1) necessitate a revision in the emission limitations or work practice requirements in the permit for the unit that were adopted in conjunction with BACT, LAER, or Clean Unit determinations; or (2) alter any physical or operational characteristics that formed the basis for the BACT, LAER, or Clean Unit determination for the unit.

Today, we are requesting comment on one aspect of the final rules for Clean units. This issue is discussed below.

The final rules allow you to maintain Clean Unit status at an emissions unit even if the area in which you are located was attainment for the pollutant at the time the emissions unit was designated clean but is subsequently redesignated to nonattainment. Our 1996 proposal did not specifically address this issue. It did, however, propose that Clean Unit status would presumptively apply for the 10 years following issuance of the major NSR permit, and it did not indicate that the presumption would be revoked if the area was redesignated. Therefore, we believe a natural implication of the proposal is that the Clean Unit status would presumptively continue to apply even if the area were redesignated.

We continue to believe that you should be allowed to maintain your Clean Unit status even if your area is redesignated from attainment to nonattainment for the pollutant for which your emissions unit is designated clean. This approach is most consistent with our current practices and fundamental to the policy of creating incentives to reduce emissions.

As a general rule, permitting decisions are not per se invalid, or retroactively changed by virtue of a change in an area's attainment status. For example, we do not require sources that have applied BACT to upgrade controls to comply with LAER or obtain offsets when an area's designation changes.

Moreover, a fundamental premise in creating the Clean Unit Test is to provide you with an incentive to install better emissions control technologies even when there is no State, local or Federal regulation requiring this level of control. We believe that this incentive will be undermined if you are unable to know with certainty that the added flexibility will be available to you for the full 10-year period.

We also believe that this approach is consistent with the Clean Air Act. The requirements of section 173 of the Act, including the requirements to apply LAER and obtain offsets, apply only if a project will result in an emissions increase. As long as an emissions unit maintains its status as a Clean Unit, it has not increased emissions. Thus, the provisions of section 173 do not apply to such emissions units.

Finally, because States will have established the Clean Units either through the major NSR permitting process or another permitting process, the State will be aware of which emissions units qualify as Clean Units at the time an area is redesignated. Thus, States that are concerned that Clean Units may have adverse impact on their attainment demonstrations if the full effect of their potential emissions is realized are able to make appropriate adjustments in their attainment demonstrations to account for these permitted emissions. In this respect, we believe that the Clean Unit Test provides States with a better planning tool than may otherwise exist in the absence of the Clean Unit Test.

As noted above, we proposed in 1996 that an emission unit's Clean Unit status would remain in place for 10 years, and implicitly indicated that nonattainment redesignation would not affect the unit's status during that 10 years. We, however, request comment on this approach and the rationale set forth above.

On December 31, 2002, we finalized rule changes to the regulations governing the NSR programs mandated by parts C and D of title I of the Act. With today's action we are proposing no changes to the final rules, and are seeking additional comments on some of the provisions finalized in the December 2002 Federal Register notice (67 FR 80186). Accordingly, we believe that the rationale provided with the final rules is still applicable and sufficient.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

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

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

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

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

Pursuant to the terms of Executive Order 12866, OMB has notified EPA that it considers this a “significant regulatory action” within the meaning of the Executive Order. EPA has submitted this action to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

This action does not impose any new information collection burden. We are not proposing any new paperwork ( e.g. , monitoring, reporting, recordkeeping) as part of today's notice. With this action we are seeking additional comments on some of the provisions finalized in the December 2002 Federal Register Notice (67 FR 80186). However, OMB has previously approved the information collection requirements contained in the existing regulations [40 CFR Parts 51 and 52] under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , and has assigned OMB control number 2060-0003, EPA ICR number 1230.11. A copy of the OMB approved Information Collection Request (ICR) may be obtained from Susan Auby, Collection Strategies Division; U.S. Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC 20460 or by calling (202) 566-1672.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's notice on small entities, small entity is defined as: (1) A small business that is a small industrial entity as defined in the U.S. Small Business Administration (SBA) size standards. ( See 13 CFR 121.201); (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's notice on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the proposed rule on small entities.” 5 U.S.C. sections 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect, on all of the small entities subject to the rule. A Regulatory Flexibility Act Screening Analysis (RFASA), developed as part of a 1994 draft Regulatory Impact Analysis (RIA) and incorporated into the September 1995 ICR renewal analysis, showed that the changes to the NSR program due to the 1990 Clean Air Act amendments would not have an adverse impact on small entities. This analysis encompassed the entire universe of applicable major sources that were likely to also be small businesses (approximately 50 “small business” major sources). Because the administrative burden of the NSR program is the primary source of the NSR program's regulatory costs, the analysis estimated a negligible “cost to sales” (regulatory cost divided by the business category mean revenue) ratio for this source group. Currently, and as reported in the current ICR, there is no economic basis for a different conclusion.

We believe the rule changes in the December 31, 2002 final rule will reduce the regulatory burden associated with the major NSR program for all sources, including all small businesses, by improving the operational flexibility of owners and operators, improving the clarity of requirements, and providing alternatives that sources may take advantage of to further improve their operational flexibility. We do not expect that today's action will change our overall assessment of regulatory burden so substantially as to result in a significant adverse impact on any source. As a result, we do not expect that today's action will result in a significant adverse impact on any small entity.

We continue to be interested in the potential impacts of today's action on small entities and welcome comments on issues related to such impacts.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective or least burdensome alternative if the Administrator publishes with the final rule an explanation as to why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan.

The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

We have determined that today's notice does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. Although initially the changes in the December 31, 2002 final rule are expected to result in a small increase in the burden imposed upon reviewing authorities in order for them to be included in the State's SIP, as well as other small increases in burden discussed under “Paperwork Reduction Act” in the preamble to the December 31, 2002 final rule, those revisions will ultimately provide greater operational flexibility to sources permitted by the States, which will in turn reduce the overall burden of the program on State and local authorities by reducing the number of required permit modifications. In addition, we believe the 2002 rule changes will actually reduce the regulatory burden associated with the major NSR program by improving the operational flexibility of owners and operators, improving the clarity of requirements, and providing alternatives that sources may take advantage of to further improve their operational flexibility. Because we are proposing no changes to the final rule, we believe that the same is true for today's notice. It is highly unlikely that today's action would increase regulatory burden to the extent of requiring expenditures of $100 million or more by State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. Thus, today's action is not subject to the requirements of sections 202 and 205 of the UMRA.

For the same reasons stated above, we have determined that today's notice contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, today's action is not subject to the requirements of section 203 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), 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.”

Today's action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. While the final rule published on December 31, 2002 will result in some expenditures by the States, we expect those expenditures to be limited to $331,250 per year. This figure includes the small increase in the burden imposed upon reviewing authorities in order for them to revise the State's SIP. However, the revisions contained in the December 31, 2002 final rule provide greater operational flexibility to sources permitted by the States, which will in turn reduce the overall burden of the program on State and local authorities by reducing the number of required permit modifications. Because we are proposing no changes to the final rules, we do not expect that today's notice would increase regulatory burden to the extent that it would result in substantial direct effects on the States. Thus, Executive Order 13132 does not apply to today's notice.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on today's action from State and local officials.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” Today's action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

The purpose of the December 31, 2002 final rule is to add greater flexibility to the existing major NSR regulations. Those changes will benefit permitting authorities and the regulated community, including any major source owned by a tribal government or located in or near tribal land, by providing increased certainty as to when the requirements of the NSR program apply. Taken as a whole, the December 31, 2002 final rule should result in no added burden or compliance costs and should not substantially change the level of environmental performance achieved under the previous rules.

EPA anticipates that initially the changes in the December 31, 2002 final rule will result in a small increase in the burden imposed upon Reviewing Authorities in order for them to be included in the State's SIP. Nevertheless, those revisions will ultimately provide greater operational flexibility to sources permitted by the States, which will in turn reduce the overall burden of the program on State and local authorities by reducing the number of required permit modifications. In comparison, no tribal government currently has an approved tribal implementation plan (TIP) under the Clean Air Act to implement the NSR program. The Federal government is currently the NSR permitting authority in Indian country. Thus, tribal governments should not experience added burden from the December 31, 2002 final rule, nor should their laws be affected with respect to implementation of that rule. Additionally, although major stationary sources affected by the December 31, 2002 final rule could be located in or near Indian country and/or be owned or operated by tribal governments, such sources would not incur additional costs or compliance burdens as a result of that rule. Instead, the only effect on such sources should be the benefit of the added certainty and flexibility provided by that rule. For the reasons stated above, we do not believe that any changes resulting from today's notice would increase burden for tribal governments. In addition, we do not anticipate that any such changes would have substantial direct effects on sources located in or near Indian country or sources owned or operated by tribal governments.

EPA specifically solicits additional comment on today's notice from tribal officials.

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

Today's action is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. We believe that the December 31, 2002 final rule as a whole will result in equal or better environmental protection than provided by earlier regulations, and do so in a more streamlined and effective manner. Similarly, today's notice is not expected to change substantially the level of environmental protection provided by the December 31, 2002 final rule, and as a result, it is not expected to present a disproportionate environmental health or safety risk for children.

Today's notice is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The December 31, 2002 final rule improves the ability of sources to undertake pollution prevention or energy efficiency projects, switch to less polluting fuels or raw materials, maintain the reliability of production facilities, and effectively utilize and improve existing capacity. That rule also includes a number of provisions to streamline administrative and permitting processes so that facilities can quickly accommodate changes in supply and demand. It provides several alternatives that are specifically designed to reduce administrative burden for sources that use pollution prevention or energy efficient projects. We do not expect that today's action would result in changes to the final rules that are so substantial as to have a significant adverse effect on the supply, distribution, or use of energy.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical.

Voluntary consensus standards are technical standards (for example, materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

Today's notice does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

The statutory authority for this action is provided by sections 307(d)(7)(B), 101, 111, 114, 116, and 301 of the CAA as amended (42 U.S.C. 7401, 7411, 7414, 7416, and 7601). This notice is also subject to section 307(d) of the CAA (42 U.S.C. 7407(d)).

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

On April 30, 2000, the Governor of Texas submitted to us rule revisions to 30 TAC, Chapter 117, Control of Air Pollution From Nitrogen Compounds concerning cement kilns operations (April 30, 2000 SIP submittal). The April 30, 2000 SIP submittal specifically addressed revisions to the following sections of Chapter 117.

In CEMEX USA (CEMEX) and TXI Operations, LP (TXI) v. TCEQ, Case No. GN001480 (Travis Co. Dist. Ct. April 30, 2003), CEMEX and TXI challenged the State for adopting the above revision to Chapter 117. As a part of a negotiated settlement of the case, TCEQ issued a re-proposal to revise 30 TAC, Chapter 117, on October 24, 2002. The incorporation of the re-proposal into the SIP may result in better compliance by the regulated community and thus more certainty that the emission reductions will actually occur.

On December 9, 2002, EPA submitted comments to TCEQ concerning re-proposed revisions to Chapter 117.

On April 2, 2003, TCEQ submitted a revised Chapter 117, Control of Air Pollution from Nitrogen Compounds rule concerning cement kilns operations as a revision to the SIP (April 2, 2003 SIP submittal). The April 2, 2003 SIP submittal specifically addressed revisions to the following sections of Chapter 117.

See our TSD for additional details/information and our evaluation of these submittals.

The April 30, 2000 and April 2, 2003 SIP submittals require the affected sources to reduce their NO X emissions from cement kilns by at least thirty percent from the 1996 baseline emissions levels. The April 30, 2000 and April 2, 2003 SIP submittals also offer operational flexibility to the affected sources to comply with the NO X emissions limitations. We are approving these revisions to the Texas SIP because they will contribute to attainment of the 1-hour ozone NAAQS, and as a measure to strengthen the SIP. We are approving these revisions to the Texas SIP as meeting the requirements of the Act.

Nitrogen oxides belong to the group of criteria air pollutants. NO X results from burning fuels, including gasoline and coal. Nitrogen oxides react with volatile organic compounds (VOC) to form ozone or smog and are also major components of acid rain.

Section 110 of the Act requires States to develop air pollution regulations and control strategies to ensure that State air quality meets the NAAQS that EPA has established. Under section 109 of the Act, EPA established the NAAQS to protect public health. The NAAQS address six criteria pollutants. These criteria pollutants are: carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide.

Each State must submit these regulations and control strategies to us for approval and incorporation into the federally enforceable SIP. Each federally approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive, containing State regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.

Currently, Texas SIP contains no federally-approved requirements for controlling NO X emissions from cement kilns. By approving the April 30, 2000 and April 2, 2003 SIP submittals we will be strengthening the Texas SIP compliance for enforcement purposes.

These rule revisions require at least 30% reductions of NO X compared with the 1996 baseline emission inventory from cement kilns operating in Bexar, Comal, Ellis, Hays, and McLennan Counties (East and Central Texas). The following two tables contain a summary of these SIP revisions for cement kilns in East and Central Texas.

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

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

• Antimicrobial pesticides (NAICS 32561)

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 unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0059. The official public docket is intended to serve as a repository for materials (i.e., documents and other information) submitted to the Agency in connection with this action and/or relied upon by the Agency in taking this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805. To the extent that a particular document is not located in the official public docket, consult the person listed under FOR FURTHER INFORMATION CONTACT .

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under 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.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of October 22, 2002 (67 FR 32231) (FRL-7275-7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(d), as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 2F06453) by Earth BioSciences, 451 Orange St, New Haven, CT 06511. This notice included a summary of the petition prepared by the petitioner Earth BioSciences. There were no comments received in response to the Notice of Filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus subtilis var. amyloliquefaciens strain FZB24.

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 exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA 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) of the FFDCA 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. . . .” Additionally, section 408(b)(2)(D) of the FFDCA requires that 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 performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of the 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.

Earth BioSciences, formerly Taensa, Inc., conducted the toxicology studies required under section 408(d)(2)(A) of the FFDCA to support its petition for an exemption from the requirement of tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24. As illustrated below, the studies conducted indicate a low mammalian toxicity for Bacillus subtilis var. amyloliquefaciens strain FZB24. In addition, no pathogenicity or infectivity was observed in any of the tests conducted with Bacillus subtilis var. amyloliquefaciens strain FZB24. All toxicology data generated by Earth BioSciences have been reviewed by the Biopesticides and Pollution Prevention Division (“BPPD”).

Toxicology data in support of the exemption from the requirement of a tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24 included studies with spores (technical) and with the formulated product (water dispersible powder) as follows:

1. Acute toxicity and/or pathogenicity —i. Bacillus subtilis var. amyloliquefaciens strain FZB24 Spores (Technical):

•  Acute oral toxicity/pathogenicity in rats . “. . . does not appear to be toxic and/or pathogenic in rats when dosed at 1.3 x 10 8 cfu.” BPPD Review of Product Chemistry and Toxicity/Pathogenicity Data Submitted by Taensa, Inc., for the Registration of TAE-022 and TAE-022 WDG, which contains Bacillus subtilis var. amyloliquefaciens strain FZB24 (Submission No.: S559221; DP Barcode: 254584; Master Record Identification (MRID) No's.: 447581-01 through 447581-20) (hereinafter referred to as “BPPD Review - December 20, 1999”).

•  Acute dermal toxicity/pathogenicity in rabbits. “The severity of irritation persisted 72 hours, and slight irritation persisted for 10 days, and all resolved by day 11. No deaths observed. The acute lethal dose (LD 50 ) is greater than 2,000 mg/kg . . . Dermal Toxicity = Toxicity III.” (BPPD Review - December 20, 1999).

•  Acute inhalation toxicity in rats. “The inhalation LC 50 for males, females, and combined was > 0.93 mg/L. Toxicity Category III.” (Submission No.: S616797; DP Barcode: 283473; MRID No's.: 456725-01 and 456725-02) (hereinafter referred to as “BPPD Review - April 25, 2002”)

•  Acute pulmonary toxicity/pathogenicity in rats. “. . . does not appear to be toxic and/or pathogenic in rats, when dosed at 1.3 x 10 8 cfu/animal. No total clearance is seen form the lungs of treated test animals . . . showed a distinct pattern of clearance from kidney, liver, and spleen.” (BPPD Review - December 20, 1999).

•  Acute intravenous toxicity/pathogenicity in rats. “. . . does not appear to be toxic and/or pathogenic in rats, when dosed at 1.7 x 10 8 cfu/animal.” (BPPD Review - December 20, 1999).

•  Primary eye irritation. “. . . showed no signs of persistent irritation into day 21, when dosed at 4.7 x 10 10 cfu/right eye/animal.” (BPPD Review - December 20, 1999.) The December 20, 1999 BPPD review indicated Toxicity Category I, but was amended in a March 7, 2000 review to Toxicity Category II based on a comparison of test animals showing similar recovery trends and leading to reversibility within 21 days. Addendum to Toxicity Category for TAE-022, which contains Bacillus subtilis var. amyloliquefaciens Strain FZB24 (Submission No.: S559221; DP Barcode: 254584; MRID No.: 447581-14).

•  Primary dermal irritation. “. . . severity of irritations persisted > 72 hours, but resolved by day 11. Dermal irritation = Toxicity II.” (BPPD Review - December 20, 1999).

•  Hypersensitivity testing. “Based on the submitted data . . . does not appear to be a sensitizer when dosed at 3.6 x 10 10 cfu.” (BPPD Review - December 20, 1999).

•  Hypersensitivity incident reporting. “No recorded or reported hypersensitivity reaction . . . based on handling MCPA in lab control setting, equating to 55 person years. . .” (BPPD Review - December 20, 1999).

•  Immune response. “There is no information to suggest that Bacillus subtilis var. amyloliquefaciens strain FZB24 has an effect on the immune system. The submitted toxicity/pathogenicity studies in rodents indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient.” (BPPD Review - December 20, 1999).

•  Potential health effects. “Based on information given, there are no apparent negative effects . . . Cited literature on B. subtilis indicate and/or support the development as a biological control. . .” (BPPD Review - December 20, 1999).

•  Growth parameters. “. . . is shown to grow at all tested temperatures (e.g., 30, 34, 37, and 50 °C). The enumeration shows a low 4.2 x 10 11 cfu/g at 37 °C to a high 6.0 x 10 11 cfu/g at 34 °C.” (BPPD Review - December 20, 1999).

ii. Bacillus subtilis var. amyloliquefaciens strain FZB24 WDG (Formulation):

•  Acute oral LD 50 toxicity in rats. “Toxic/limit dose . . . is greater than 2.8 g/kg body weight (6.7 x 10 10 cfu/kg). . . Toxicity Category III.” (BPPD Review - December 20, 1999).

•  Acute dermal LD 50 toxicity in rats. “The severity of irritation persisted > 72 hours, but resolved by day 11. No deaths observed. The acute dose (LD 50 ) is greater than 2,000 mg/kg. . . . Dermal irritation = Toxicity Category II; Dermal Toxicity = Toxicity Category III.” (BPPD Review - December 20, 1999).

•  Acute inhalation lethal concentration (LC 50 ) toxicity in rats (Formulation). “. . . an acute inhalation medium (LC 50 ) in male and female rats is greater than 0.93 mg/L . . . Toxicity Category III.” (BPPD Review - April 25, 2002)

•  Primary eye irritation. “No corneal opacity, and no signs of irritation by day 7, when dosed . . . at 3.6 x 10 10 cfu/right eye/animal. . . . Toxicity Category III.” (BPPD Review - December 20, 1999).

•  Hypersensitivity. “Not a sensitizer when dosed at 3.6 x 10 10 cfu. No hypersensitivity incidents have been reported.” (BPPD Review - December 20, 1999).

Based on the data generated in accordance with the Tier I data requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III data requirements were not triggered and, therefore, not required in connection with this action.

In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Bacillus subtilis var. amyloliquefaciens strain FZB24 is a naturally-occurring microorganism and widespread in the environment. The low toxicity and non-pathogenicity/infectivity of Bacillus subtilis var. amyloliquefaciens strain FZB24 is demonstrated by the data summarized in this action. The end-use (formulated) product will be applied to all agricultural commodities as a seed treatment and via incorporation, drenching, spraying, dipping, chemigation and hydroponics.

1. Food . While the proposed use pattern may result in dietary exposure with possible residues on all agricultural commodities, negligible risk is expected for the general population, as well as for infants and children. Submitted acute toxicology tests (MRID Numbers 447581-08, 447581-09, 447581-10, 447581-11, 447581-12, 447581-13, 447581-14, 447581-16, and 456725-02) demonstrate that based upon the use sites, use patterns, application method, use rates, low exposure, and minimal risk of toxicity, the potential risks from dietary exposure for both the general population and infants and children are considered low.

2. Drinking water exposure . Although Bacillus subtilis var. amyloliquefaciens strain FZB24 spores may be found naturally in water, it is not known as an aquatic bacterium, and therefore is not expected to proliferate in aquatic habitats. (Earth BioSciences petition from the requirement of a tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24, dated May 3, 2002.) In addition, the potential for transfer of Bacillus subtilis var. amyloliquefaciens strain FZB24 to surface or ground water during run-off associated with intended use applications is considered minimal to non-existent, due in part to its percolation through and resulting capture in soil. Most importantly, though, the risk from consumption of drinking water containing Bacillus subtilis var. amyloliquefaciens strain FZB24 is considered minimal as there is no evidence of adverse effects from oral, dermal, or inhalation exposure to this microbial agent. (See Unit III.) Accordingly, it is not considered to be a risk to drinking water.

Based on the proposed use patterns, the potential of non-dietary exposures to Bacillus subtilis var. amyloliquefaciens strain FZB24 pesticide residues for the general population, including infants and children, is unlikely. Accordingly, the Agency believes that the potential aggregate non-occupational exposure, derived from dermal and inhalation exposure through the application of Bacillus subtilis var. amyloliquefaciens strain FZB24, should fall well below the currently tested microbial safety levels. (MRID Numbers 447581-10, 447581-11, 447581-12, and 456725-02).

1. Dermal exposure . Dermal exposure via the skin is a potential route of exposure resulting from applications of Bacillus subtilis var. amyloliquefaciens strain FZB24. Unbroken skin is a natural barrier to microbial invasion of the human body. Dermal absorption could occur only if the skin were cut, if the microbe were a pathogen equipped with mechanisms for entry through or infection of the skin, or if metabolites were produced that could be dermally absorbed. Acute dermal toxicity/pathogenicity data resulted in irritation that persisted 72 hours, and slight irritation persisted for 10 days, and all resolved by day 11. No deaths were observed. The acute lethal dose (LD 50 ) is greater than 2,000 mg/kg. (BPPD Review - December 20, 1999). Accordingly, the risks anticipated for this route of exposure are considered minimal.

2. Inhalation exposure . Inhalation would be an additional potential route of exposure resulting from applications of Bacillus subtilis var. amyloliquefaciens strain FZB24. However, because the pulmonary study showed no adverse effects (MRID Numbers 447581-12 and 456725-02) the risks anticipated for this route of exposure are considered minimal.

The Agency has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity to Bacillus subtilis var. amyloliquefaciens strain FZB24, the Agency is confident that there will not be cumulative effects from the residues of this product on all agricultural commodities. (See Unit III.)

1. U.S. population . Bacillus subtilis var. amyloliquefaciens strain FZB24 is a naturally occurring microorganism and Bacillus subtilis var. amyloliquefaciens is widespread in the environment. Based on the very low levels of mammalian toxicity associated with Bacillus subtilis var. amyloliquefaciens strain FZB24, which is demonstrated by the data summarized above, and the history of safe use of B. subtilis , the Agency has concluded that there is a reasonable certainty that no harm will result from aggregate exposure to residues of Bacillus subtilis var. amyloliquefaciens strain FZB24 to the U.S. population. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. Accordingly, exempting Bacillus subtilis var. amyloliquefaciens strain FZB24 from the requirement of a tolerance should be considered safe and pose no significant risk.

2. Infants and children . FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of exposure (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 exposure (safety) will be safe for infants and children. Margins of exposure (safety) are incorporated into EPA risk assessments either directly through the use of a margin of exposure analysis or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. Here, EPA concludes that the toxicity and exposure data are sufficiently complete to adequately address the potential for additional sensitivity of infants and children to residues of Bacillus subtilis var. amyloliquefaciens strain FZB24 and that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to Bacillus subtilis var. amyloliquefaciens strain FZB24 residues. Also, for food use of microbial pesticides, the acute toxicity/pathogenicity studies have allowed for the conclusion that an exemption from the requirement of a tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24 is appropriate and adequate to protect human health, including that of infants and children.

EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there is no scientific basis for including, as part of the screening program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, Bacillus subtilis var. amyloliquefaciens strain FZB24 may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.

Based on available data, no endocrine system-related effects have been identified with consumption of Bacillus subtilis var. amyloliquefaciens strain FZB24. It is a naturally occurring bacteria that is widespread in the environment. To date, there is no evidence to suggest that Bacillus subtilis var. amyloliquefaciens strain FZB24 affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above, including Bacillus subtilis var. amyloliquefaciens strain FZB24's lack of mammalian toxicity. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purpose for Bacillus subtilis var. amyloliquefaciens strain FZB24.

There are no Codex maximum residue levels established for residues of Bacillus subtilis var. amyloliquefaciens strain FZB24.

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, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA 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) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your written objections and hearing requests with the Hearing Clerk 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 ID number OPP-2003-0059 in the subject line on the first page of your submission. All objections and hearing requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 29, 2003.

1. Filing the request . Your objections 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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

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 20460-0001.

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 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.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.1. Mail your copies, identified by docket ID number OPP-2003-0059, 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 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. 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 for Bacillus subtilis var. amyloliquefaciens strain FZB24 under section 408(d) of the FFDCA 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). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any 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 section 408(d) of the FFDCA, such as the exemption from the tolerance requirement 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 section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

•Crop production (NAICS 111)

•Animal production (NACIS 112)

•Food manufacturer (NAICS 311)

•Pesticide manufacturer (NAICS 32532)]

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 unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0246. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under 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. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of February 14, 2003 (68 FR 7542) (FRL-7289- 5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 1F6313) by BASF Corporation, P.O. Box 13528, Research Triangle Park, North Carolina 27708-2000. That notice included a summary of the petition prepared by BASF Corporation, the registrant. The Agency received one public comment and it, along with the Agency's response, can be found in Unit V.

The petition (1F6313) requested that 40 CFR 180.589 be amended by establishing a tolerance for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or on vegetable, root, subgroup 1B at 1.0 ppm; vegetables, tuberous and corm, subgroup 1C at 0.05 ppm; vegetable, root and tuber, leaves, group 2 at 1.0 ppm; vegetable, bulb, group 3 at 3.0 ppm; vegetable, leafy, group 4, at 11.0 ppm; vegetable, Brassica leafy, subgroup 5A, at 3.0 ppm; vegetable, Brassica leafy, subgroup 5B, at 18.0 ppm; vegetable, legume, group 6, at 2.2 ppm; vegetable, legume foliage, group 7,forage at 1.5 ppm; vegetable,, legume, foliage, group 7, hay at 2.0 ppm vegetable, legume, foliage group 7, vines at 0.05 ppm; vegetable, fruiting, group 8 at 1.0 ppm; vegetable, cucurbit, group 9, at 1.5 ppm; fruit, stone, group 12 at 1.7 ppm; berries, group 13 at 3.5 ppm; nut, tree, group 14 at 0.25 ppm; almond, hulls at 3.0 ppm; pistachio at 0.65 ppm; grain, cereal, group 15 at 0.2 ppm; grain, cereal , forage, fodder, and straw, group 16, forage at 2.0 ppm; grain, cereal , forage, fodder, and straw, group 16, straw at 3.0 ppm; grain, cereal , forage, fodder, and straw, group 16, fodder at 1.5 ppm grass, forage, fodder, and hay, group 17, forage at 2.0 ppm; grass, forage, fodder, and hay, group 17, hay at 8.0 ppm; animal feed, nongrass, group 18, forage at 1.0 ppm; animal feed, nongrass, group 18, hay at 2.0 ppm; animal feed, nongrass, group 18 seed at 0.05 ppm; mint at 30.0 ppm; grape at 3.5 ppm; grape, raisin at 8.5 ppm; strawberry at 1.2 ppm; canola at 3.5 ppm; peanut at 0.05 ppm; peanut, meal at 0.15 ppm; peanut, refined oil at 0.15 ppm; cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 0.3 ppm; soybean, seed at 0.1 ppm; soybean, hulls at 0.2 ppm; flax seed at 3.5 ppm and sunflower, seed at 3.5 ppm.

The petition (1F6313) also requested that 40 CFR 180.589 be amended by establishing a tolerance for combined residues of the fungicide 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) and metabolites M510F01 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl) nicotinamide and M510F02 glucuronic acid conjugate of M510F01 in or on: Cow milk at 0.10 ppm; cow muscle, at 0.10 ppm; cow, fat at 0.30 ppm; cow, meat byproducts at 0.35 ppm; egg at 0.02 ppm; and poultry muscle, poultry fat, and poultry meat byproducts at 0.05 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA 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) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA 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) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) on: Vegetable, root, subgroup 1A, except sugar beet/garden beet/radish/turnip, at 1.0 ppm; vegetable, tuberous and corm, subgroup 1C, at 0.05 ppm; vegetable, bulb, group 3, at 3.0 ppm; lettuce, head at 6.5 ppm; lettuce, leaf at 11.0 ppm; vegetable, Brassica leafy, head and stem, subgroup 5A, at 3.0 ppm; vegetable, Brassica leafy, leafy greens, subgroup 5B, at 18.0 ppm; vegetable, legume, edible-podded, subgroup 6A, at 1.6 ppm; vegetable, legume, succulent shelled pea and bean, subgroup 6B, except cowpea; at 0.6 ppm; vegetable, legume, dried shell pea and bean (except soybean), subgroup 6C, except cowpea, field pea, and grain lupin at 2.5 ppm; vegetable, fruiting, group 8, at 1.2 ppm; vegetable, cucurbit, group 9, except cucumber, at 1.6 ppm; cucumber at 0.20 ppm; fruit, stone, group 12, at 1.7 ppm; berries, group 13, at 3.5 ppm; nut, tree, group 14, at 0.70 ppm; almond, hulls at 3.0 ppm; pistachio at 0.70 ppm; grape at 3.5 ppm; grape, raisin at 8.5 ppm; strawberry at 1.2 ppm; peanut at 0.05 ppm; peanut, meal at 0.15 ppm; peanut, refined oil at 0.15ppm; canola, seed at 3.5 ppm; canola, refined oil at 5.0 ppm; sunflower, seed at 0.60 ppm; peppermint, tops at 30.0 ppm and spearmint, tops at 30.0 ppm.

The Agency also included in this risk assessment dietary exposure (at the anticipated tolerance level) from another pesticide petition (2F6434) for boscalid use on pome fruit and hops. However, the Agency is not establishing tolerances for these commodities at this time, because the residue chemistry review for these commodities is not complete and in fact is not scheduled until the Office of Pesticide Program FY-2004 Workplan.

In addition, also consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of boscalid from indirect or inadvertent residues (from rotational crop use), 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) on: Beet, garden, roots at 1.0 ppm; radish, roots at 1.0 ppm; turnip, roots at 1.0 ppm; beet, sugar, roots at 1.0 ppm; vegetable, root and tuber, leaves, group 2 at 1.0 ppm; vegetable, leafy, group 4, except lettuce at 1.0 ppm; vegetable, legume foliage, group 7, forage at 1.5 ppm; vegetable, legume, foliage, group 7, hay at 2.0 ppm; vegetable, legume, foliage group 7, vines at 0.05 ppm; grain, cereal, group 15, at 0.20 ppm; rice, hulls at 0.50 ppm; grain, cereal , forage, fodder, and straw, group 16, fodder at 1.5 ppm; grain, cereal , forage, fodder, and straw, group 16, forage at 2.0 ppm; grain, cereal , forage, fodder, and straw, group 16, straw at 3.0 ppm; grass, forage, fodder, and hay, group 17, forage at 2.0 ppm; grass, forage, fodder, and hay, group 17, hay at 8.0 ppm; grass, forage, fodder, and hay, group 17, straw at 0.30 ppm; grass, forage, fodder, and hay, group 17, seed screenings at 0.20 ppm; animal feed, nongrass, group 18, forage at 1.0 ppm animal feed, nongrass, group 18, hay at 2.0 ppm; animal feed, nongrass, group 18 seed at 0.05 ppm; cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 0.30 ppm; soybean, seed, 0.10 ppm; soybean, hulls at 0.20 ppm; cowpea, seed at 0.1 ppm; lupin, grain, grain, at 0.1 ppm; pea, field, seed at 0.1 ppm and flax seed at 3.5 ppm.

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for combined residues of the fungicide 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) and metabolites M510F01 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl) nicotinamide and M510F02 glucuronic acid conjugate of M510F01 in or on milk at 0.10 ppm, cattle, meat at 0.10 ppm, cattle, fat at 0.30 ppm, cattle, meat byproducts at 0.35 ppm, egg at 0.02 ppm, poultry, meat at 0.05 ppm, poultry, fat at 0.05 ppm, poultry, meat byproducts at 0.10 ppm, goat, meat at 0.10 ppm, goat, fat at 0.30 ppm, goat, meat byproducts at 0.35 ppm, hog, meat at 0.05 ppm, hog, fat at 0.10 ppm, hog, meat byproducts at 0.35 ppm, horse, meat at 0.10 ppm, horse, fat at 0.30 ppm, horse, meat byproducts at 0.35 ppm, sheep, meat at 0.10 ppm, sheep, fat at 0.30 ppm, and sheep, meat byproducts at 0.35 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

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

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) 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 SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the 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 boscalid used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . These are the first food uses and tolerances for residues of boscalid, in or on raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from boscalid in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate acute-dietary risk to the general population, including infants and children, or to the subpopulation females 13-50 years old. Therefore, there is no acute reference dose (aRfD) or acute population-adjusted dose (aPAD).

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 1994-1996 and 1998 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 were assumed for all commodities associated with PP 1F6313 with the exception of a few crops where levels higher than the tolerance were used. The latter were due to the lowering of some tolerances to harmonize with Canadian MRL's subsequent to the dietary risk assessment. Pome fruit and hops were also included from PP 2F6434 using the likely tolerance levels. One hundred percent crop treated was assumed for all commodities. Processing factors were either empirical or the default values in DEEM.

iii. Cancer . The Agency determined that boscalid produced suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential. This cancer classification was based on the following weight of evidence considerations. First, in male Wistar rats, there was a significant trend (but not pairwise comparison) for the combined thyroid adenomas and carcinomas. This trend was driven by the increase in adenomas. Second, in the female rats, there was only a borderline significant trend for thyroid adenomas (there were no carcinomas). Third, the mouse study was negative as were all of the mutagenic tests. Consistent with this weak evidence of carcinogenic effects, the Agency concluded that a dose-response assessment for cancer (either linear low-dose extrapolation or margin of exposure calculation) was not needed.

iv. Anticipated residue and percent crop treated (PCT) information . The Agency used tolerance level residues and 100% crop treated for this risk analysis.

2. Dietary exposure from drinking water . This is a new chemical and 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 boscalid.

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, 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 boscalid they are further discussed in the aggregate risk sections in Unit III.E.

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of boscalid for chronic exposures are estimated to be 25.6 ug/L for surface water and 0.571 ug/L for ground water. The Agency notes that for surface and groundwater assessments, the application rate for turf was used, which represents the highest seasonal application rate (2.1 lbs. active ingredient/acre/season). The highest single application rate associated with the use of the pesticide on fruiting vegetables, did not result in EEC values higher than those calculated for turf use since the proposed total seasonal application rate for fruiting vegetables is only 1.1 lb. active ingredient/acre/season.

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).

Boscalid is currently being registered for use on the following residential non-dietary sites: The boscalid label with turf use specifies that this product is intended for golf course use only, and not for use on residential turfgrass or turfgrass being grown for sale or other commercial use such as sod production. Although the label does not indicate that the product is applied by licenced or commercial applicators, homeowners will not be applying the product to golf courses. Therefore, a risk assessment for residential handler exposure is not required. The risk assessment was conducted using the following residential exposure assumptions: The Agency uses the term post-application to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. There are two recreational scenarios associated with boscalid that could lead to exposures for adults and children: (i) Adults and youth golfing and (ii) adults and children picking their own fruit. These exposure durations are anticipated to be short term. Because U-pick is a one-time event (duration < 1 day) and the Agency found that the oral studies indicated there were no endpoints appropriate to quantitate acute risk, the U-pick exposure/risk was not evaluated. Therefore, only the golfing scenario was evaluated with respect to non-occupational, non-dietary exposure. The dermal MOEs for adults golfing were 27,000-74,000. Although specific MOEs were not calculated for youths playing golf, the adult MOEs are considered representative since the body surface area to weight ratios for adolescents do not vary significantly from those for adults. The refined assessment is based on reliable data and is unlikely to underestimate exposure/risk.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the FFDCA 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 boscalid 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, boscalid 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 boscalid has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general . Section 408 of the FFDCA 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 MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . The Agency concluded that there are no residual uncertainties for pre- and post-natal toxicity as the degree of concern is low for the susceptibility seen in the above studies, and the dose and endpoints selected for the overall risk assessments will address the concerns for the body weight effects seen in the offspring. Although the dose selected for overall risk assessments (21.8 mg/kg/day) is higher than the NOAELs in the 2-generation reproduction study (10.1 mg/kg/day) and the developmental neurotoxicity study (14 mg/kg/day), these differences are considered to be an artifact of the dose selection process in these studies. For example, there is a 10-fold difference between the LOAEL (106.8 mg/kg/day) and the NOAEL (10.1 mg/kg/day) in the two generation reproduction study. A similar pattern was seen with regard to the developmental neurotoxicity study, where there is also a 10-fold difference between the LOAEL (147 mg/kg/day) and the NOAEL (14 mg/kg/day). There is only a 2-3 fold difference between the LOAEL (57 mg/kg/day) and the NOAEL (21.8 mg/kg/day) in the critical study used for risk assessment. Because the gap between the NOAEL and LOAEL in the 2-generation reproduction and developmental neurotoxicity studies was large and the effects at the LOAELs were minimal, the true no-observed-adverse-effect-level was probably considerably higher. Therefore, the selection of the NOAEL of 21.8 mg/kg/day from the 1-year dog study is conservative and appropriate for the overall risk assessments. In addition, the endpoints for risk assessment are based on thyroid effects seen in multiple species (mice, rats and dogs) and after various exposure durations (subchronic and chronic exposures) which were not observed at the LOAELs in either the 2-generation reproduction or the developmental neurotoxicity studies. Based on these data, the Agency concluded that there are no residual uncertainties for pre- and post-natal toxicity.

3. Conclusion . There is a complete toxicity data base for boscalid and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. There is no evidence of susceptibility following in utero exposure to rats and there is low concern and no residual uncertainties in the developmental toxicity study in rabbits, in the 2-generation reproduction study or in the developmental neurotoxicity study after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment. Based on these data and conclusions, EPA reduced the FQPA Safety Factor to 1X.

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 + residential 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 Office of Water are used to calculate DWLOCs: 2 liter (L)/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 groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . As there were no toxic effects attributable to a single dose, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. Therefore, there is no acute reference dose (aRfD) or acute population-adjusted dose (aPAD) for the general population or females 13-50 years old. No acute risk is expected from exposure to boscalid.

2. Chronic risk . The chronic aggregate risk assessment takes into account average exposures estimates from dietary consumption of boscalid (food and drinking water) and residential uses. Since the exposure from turf grass (golf course) activities are considered short term, the chronic aggregate included food and drinking water only. The calculated chronic DWLOCs for chronic exposure to boscalid in drinking water range from 1,400 to 7,000 μg/L (ppb). ). The chronic aggregate risk associated with the proposed use of boscalid does not exceed the Agency's level of concern for the general U.S. population or any population subgroups. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:

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).

Boscalid is proposed for use 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 boscalid.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in an aggregate MOE of 1,200 for the general population. The short-term aggregate risk assessment takes into account average exposures estimates from dietary consumption of boscalid (food and drinking water) and residential uses. Postapplication exposures from the proposed use on golf course is considered a short term activity and applies to adults and youth. The Agency concluded that exposure from turf grass is needed to be included in the aggregate assessment. Table 4 summarizes the results. For the general population the MOE from food and residential exposure was 1,200. This MOE is also representative of the risk for youth playing golf for the reasons stated in Unit III.C.3. and the dietary exposure for youth (13-19 years old) being less than the general population. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, a short-term DWLOC was calculated and compared to the EECs for chronic exposure of boscalid in ground and surface water. The calculated short term DWLOC is 6,000 ppb. After calculating the DWLOC and comparing it 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 Table 4 of this unit:

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Boscalid is not registered for use on any sites that would result in intermediate-term residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . The Agency has classified boscalid as, “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential,” and, therefore, the quantification of human cancer risk is not recommended. See Unit III.C.iii of this document for additional details explaining why a cancer risk assessment was not required.

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

Analytical Enforcement Method for Plants. (Method D0008; MRID 45405028). This method determines residues of boscalid. Residues are extracted using an aqueous organic solvent mixture followed by liquid/liquid partitioning and column clean-up. Quantitation is by gas chromatography/mass spectrometry (GC/MS) using selected ion monitoring. The reported limit of quantitation (LOQ) is 0.05 ppm for residues of boscalid in plant matrices.

Analytical Enforcement Method for Livestock. (Method DFG S19; MRID 45405103). This method determines residues of boscalid and two metabolites 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide (M510F01) and glucuronic acid conjugate of 2-chloro-N-4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide (M510F02)] in or on the following food commodities (as 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide). Residues are extracted with methanol. The extract is treated with enzymes to release M510F02 to free M510F01. Residues are isolated by liquid/liquid partition followed by column chromatography. Total M510F01 is acetylated followed by a column clean-up. Parent and acetylated M510F01 are quantitated by GC/ECD (electron capture). The reported LOQ for each analyte is 0.01 ppm in milk and 0.025 ppm in other animal matrices.

Adequate enforcement methodology (GC/MS and GC/ECD) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

Boscalid is a new fungicide. There are currently no pending or established Codex maximum residue limits (MRLs) for boscalid, and no established Canadian or Mexican MRLs either. The US EPA and PMRA/Canada jointly reviewed this subject petition (1F6313), and the forthcoming tolerances were harmonized to the extent possible with respect to the residues of concern and tolerance levels.

Any conditions of registration will be specified in the Notice of Registration for the technical grade boscalid.

The Agency received the following comment. The Agency's response follows.

Comment . There should be zero tolerance for ths chemical on food. We do not need more chemicals added to our food. We already have far too many approved by EPA and FDA. I say if there is anything over zero effect from this toxic, that the toxic should be denied use in the USA.

Response . The one comment received in response to the Notice of Filing contained no scientific data or evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to boscalid, including all anticipated dietary exposure and all other exposures for which there is reliable information. General opposition to pesticides in food is not a sufficient reason to deny a tolerance petition.

Therefore, tolerances are established for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or on vegetable, root, subgroup 1A, except sugar beet, garden beet, radish, and turnip at 0.7 ppm; vegetable, tuberous and corm, subgroup 1C at 0.05 ppm; vegetable, bulb, group 3 at 3.0 ppm; lettuce, head at 6.5 ppm; lettuce, leaf at 11.0 ppm; vegetable, Brassica leafy, head and stem, subgroup 5A at 3.0 ppm; vegetable, Brassica leafy, leafy greens, subgroup 5B at 18.0 ppm; vegetable, legume, edible-podded, subgroup 6A, at 1.6 ppm; vegetable, legume, succulent shelled pea and bean, subgroup 6B, except cowpea; at 0.6 ppm; vegetable, legume, dried shell pea and bean (except soybean), subgroup 6C, except cowpea, field pea, and grain lupin at 2.5 ppm; vegetable, fruiting, group 8 at 1.2 ppm; vegetable, cucurbit, group 9, except cucumber at 1.6 ppm; cucumber at 0.20 ppm; fruit, stone, group 12 at 1.7 ppm; berries, group 13 at 3.5 ppm; nut, tree, group 14 at 0.70 ppm; almond, hulls at 3.0 ppm; pistachio at 0.70 ppm; grape at 3.5 ppm; grape, raisin at 8.5 ppm; strawberry at 1.2 ppm; peanut at 0.05 ppm; peanut, meal at 0.15 ppm; peanut, refined oil at 0.15 ppm; canola, seed at 3.5 ppm; canola, refined oil at 5.0 ppm; sunflower, seed at 0.60 ppm; peppermint, tops at 30.0 ppm and spearmint, tops at 30.0 ppm.

Tolerances are established for indirect or inadvertent (crop rotation) residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or on beet, garden, roots at 1.0 ppm; radish, roots, at 1.0 ppm; turnip, roots at 1.0 ppm; beet, sugar, roots at 1.0 ppm; vegetable, root and tuber, leaves, group 2 at 1.0 ppm; vegetable, leafy, group 4, except lettuce at 1.0 ppm; vegetable, legume, foliage, group 7, forage at 1.5 ppm; vegetable, legume, foliage, group 7, hay at 2.0 ppm; vegetable, legume, foliage, group 7, vines at 0.05 ppm; grain, cereal, group 15 at 0.20 ppm; rice, hulls at 0.50 ppm; grain, cereal , forage, fodder, and straw, group 16, fodder at 1.5 ppm; grain, cereal , forage, fodder, and straw, group 16, forage at 2.0 ppm; grain, cereal , forage, fodder, and straw, group 16, straw at 3.0 ppm; grass, forage, fodder, and hay, group 17, forage at 2.0 ppm; grass, forage, fodder, and hay, group 17, hay at 8.0 ppm; grass, forage, fodder, and hay, group 17, straw at 0.30 ppm; grass, forage, fodder, and hay, group 17, seed screenings at 0.20 ppm; animal feed, nongrass, group 18, forage at 1.0 ppm; animal feed, nongrass, group 18, hay at 2.0 ppm; animal feed, nongrass, group 18, seed at 0.05 ppm; cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 0.30 ppm; soybean, seed, 0.10 ppm; soybean, hulls at 0.20 ppm; cowpea, seed at 0.1 ppm; lupin, grain, grain at 0.1 ppm; pea, field, seed at 0.1 ppm and flax seed at 3.5 ppm.

Tolerances are established for the combined residues of the fungicide 3- pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) and metabolites M510F01 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl) nicotinamide and M510F02 glucuronic acid conjugate of M510F01 in or on milk at 0.10 ppm; cattle, meat at 0.10 ppm; cattle, fat at 0.30 ppm; cattle, meat byproducts at 0.35 ppm; egg at 0.02 ppm; poultry, meat at 0.05 ppm; poultry, fat at 0.05 ppm; poultry, meat byproducts at 0.10 ppm; goat, meat at 0.10 ppm; goat, fat at 0.30 ppm; goat, meat byproducts at 0.35 ppm; hog, meat at 0.05 ppm; hog, fat at 0.10 ppm; hog, meat byproducts at 0.10 ppm; horse, meat at 0.10 ppm; horse, fat at 0.30 ppm; horse, meat byproducts at 0.35 ppm; sheep, meat at 0.10 ppm; sheep, fat at 0.30 ppm and sheep, meat byproducts at 0.35 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA 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) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 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 ID number OPP-2003-0246 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 September 29, 2003.

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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

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 20460-0001.

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 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0246, 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 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes a tolerance under section 408(d) of the FFDCA 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). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any 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 section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

The information in this section is organized as follows:

A delisting petition is a request from a generator to exclude waste from the list of hazardous wastes under RCRA regulations. In a delisting petition, the petitioner must show that waste generated at a particular facility does not meet any of the criteria for which EPA listed the waste as set forth in Title 40 Code of Federal Regulations (40 CFR) § 261.11 and the background document for the waste. In addition, a petitioner must demonstrate that the waste does not exhibit any of the hazardous waste characteristics (that is, ignitability, reactivity, corrosivity, and toxicity) and must present sufficient information for us to decide whether factors other than those for which the waste was listed warrant retaining it as a hazardous waste. (See 40 CFR 260.22, 42 U.S.C. 6921(f) and the background documents for a listed waste.)

Generators remain obligated under RCRA to confirm that their waste remains nonhazardous based on the hazardous waste characteristics even if EPA has “delisted” the wastes and to ensure that future generated wastes meet the conditions set.

Under 40 CFR 260.20, 260.22, and 42 U.S.C. 6921(f), facilities may petition the EPA to remove their wastes from hazardous waste control by excluding them from the lists of hazardous wastes contained in 40 CFR 261.31 and 261.32. Specifically, 40 CFR 260.20 allows any person to petition the Administrator to modify or revoke any provision of parts 260 through 266, 268, and 273 of 40 CFR. 40 CFR 260.22 provides a generator the opportunity to petition the Administrator to exclude a waste on a “generator specific” basis from the hazardous waste lists.

Automobile manufacturers are adding aluminum to automobiles, which may result in increased fuel economy. However, when aluminum is conversion coated in the automobile assembly process, the resulting wastewater treatment sludge must be managed as EPA hazardous waste F019. A number of automotive assembly plants use a similar manufacturing process which generates a similar F019 waste likely to be nonhazardous. This similarity of manufacturing processes and the resultant wastes provides an opportunity for the automobile industry to be more efficient in submitting delisting petitions and EPA in evaluating them. Efficiency may be gained and time saved by using a standardized approach for gathering, submitting and evaluating data. Therefore, EPA, in conjunction with MDEQ, developed a pilot project to expedite the delisting process. This approach to making delisting determinations for this group of facilities is efficient while still being consistent with current laws and regulations and protective of human health and the environment.

By removing regulatory controls under RCRA, EPA is facilitating the use of aluminum in cars. EPA believes that incorporating aluminum in cars will be advantageous to the environment since lighter cars are capable of achieving better fuel economy.

The expedited process to delist F019 is an approach developed through a Memorandum of Understanding (MOU) with MDEQ for gathering and evaluating data in support of multiple petitions from automobile assembly plants. The expedited delisting process is applicable to wastes generated by automobile and light truck assembly plants in the State of Michigan which use a similar manufacturing process and generate similar F019 waste.

Based on available historical data and other information, the expedited process identified 70 constituents which might be of concern in the waste and provides that the F019 sludge generated by automobile assembly plants may be delisted if the levels of the 70 constituents do not exceed the allowable levels established for each constituent in this rulemaking. The maximum annual quantity of waste generated by any single facility which may be covered by an expedited delisting is 3,000 cubic yards, however, delisting levels were also proposed for smaller quantities of waste (1,000 and 2,000 cubic yards).

This expedited delisting process provides an opportunity for the automobile industry to be more efficient in preparing petitions and for the EPA to be more efficient in evaluating them.

Each facility submitted certification that its process was the same as the process described in the MOU with MDEQ. See 67 FR 10341, March 7, 2002. Each facility also submitted an assertion that its waste does not meet the criteria for which F019 waste was listed and there are no other factors which might cause the waste to be hazardous.

To support its petition, each facility collected 6 samples representing waste generated over 6 weeks. Each sample: (1) Was analyzed for total analyses of the 70 constituents of concern; (2) was analyzed for Toxicity Characteristic Leaching Procedure (TCLP), SW-846 Method 1311, analyses of the 70 constituents of concern; (3) was analyzed for oil and grease; (4) with more than 1% oil and grease was analyzed for leachable metals using the Extraction Procedure for Oily Wastes (OWEP), SW-846 Method 1330A, in lieu of Method 1311; (5) was analyzed for total constituent analyses for sulfide and cyanide; (6) was measured of pH and determination that waste is not corrosive (see 40 CFR 261.22); and (7) had a determination made that the waste was not reactive or ignitable. (See 40 CFR 261.21 and 40 CFR 261.23.) All sampling and analysis was done in accordance with the sampling and analysis plan which is an appendix to the MOU and is available in the docket for this rule. The data submitted included the appropriate QA/QC information as required in the sampling and analysis plan and was validated by a third party.

A few minor changes in the sampling approach were made prior to the sampling. Instead of sampling from six different roll-off boxes, which would have required multiple sampling events or long-term storage of full roll-off boxes, the facilities were allowed to fill 55-gallon drums with aliquots from each discharge from the filter press so that each drum represented a week's worth of sludge. All drums were then sampled on the same day shortly after the end of the six-week period. The maximum values of constituents detected in any sample of the waste water treatment plant sludge are summarized in the following table along with the maximum allowable concentrations in the waste. The table also includes the maximum allowable levels in groundwater, as evaluated by the Delisting Risk Assessment Software (DRAS). The groundwater levels used by DRAS are the more conservative of either the Safe Drinking Water Act Maximum Contaminant Level (MCL) or the value calculated by DRAS based on target risk levels.

EPA compared the analytical results submitted by each facility to the maximum allowable levels calculated by the DRAS and set forth in the proposed rule (March 7, 2002, 67 FR 10341). All constituents compared favorably to the allowable levels, although acrylamide, arsenic, antimony and thallium required supplemental analyses to determine that they were not present at levels which would pose a threat.

Acrylamide: Samples were initially analyzed for acrylamide using SW-846 Method 8316. The levels reported using method 8316 were in excess of the delisting levels, although the data validation report stated that this analytical method was not sufficiently selective for acrylamide in the sludge. Acrylamide is a trace contaminant in the flocculant-aide used at waste water treatment plants. The facilities submitted a detailed mass balance which concluded that the maximum possible acrylamide that could be in the sludge would be much lower than the reported detections. Rather than accept a mass balance in lieu of the reported analytical results, EPA required further supplemental analyses by a more sensitive method using SW-846 Method 8032A in Selected Ion Monitoring (SIM) mode. Four additional samples representing two days of waste were collected at each facility. No acrylamide was detected above the level of concern.

Arsenic, Thallium, and Antimony: Estimated levels of leachable arsenic reported in some samples exceeded the delisting level, while estimated levels of leachable thallium and antimony in some samples, resulted in an aggregate hazard index (HI) in excess of 1.0. Samples which were reanalyzed for these constituents using the more sensitive Method 6020 were well below the allowable levels both individually and in the aggregate. The sample from GM-Lansing Grand River was not reanalyzed for thallium and when combined with the nickel in these samples, the hazard index remained in excess of one at an annual volume of 3,000 cubic yards. To assure that the total HI remains below one, GM has requested that the annual volume of delisted waste at the Lansing Grand River plant be changed to 2,000 cubic yards, since the estimated risk from this waste decreases as the volume decreases.

Hexachlorobenzene, hexachlorobutadiene, pentachlorophenol, and 2,4 dinitrotoluene: The initial detection levels for these constituents were significantly higher than the allowable levels. To achieve lower detection levels for these constituents, samples from each facility were reanalyzed by Method 8270 using selective ion monitoring (SIM) mode. These constituents were not detected using this more sensitive method, although some detection levels were still above the allowable delisting level. We believe the analysis indicates these constituents are not present in the waste.

Methyl methacrylate: Ford did not analyze the samples for methyl methacrylate. For the annual volume which Ford will be disposing, the allowable concentration for methyl methacrylate is too high to be a practical concern.

The EPA received public comments on the proposed notice published on March 7, 2002 from Alliance of Automobile Manufacturers, Honda of America Mfg., Inc., Alcoa Inc., and The Aluminum Association. All commenters were supportive of the proposal and suggested expanding the project and revising the listing.

(1) EPA should revise the F019 listing to specify that wastewater treatment sludge from zinc phosphating operations is not within the scope of the listing. Data gathered as a result of the Expedited Delisting Project together with the available historical data, should provide enough data to fully characterize this waste and to justify a revision of the listing.

The Agency is now considering revising the F019 listing. EPA is examining the data collected as a result of this project, as well as past data, as a basis for a possible revision to the F019 listing.

(2) EPA should issue an interpretive rule clarifying that zinc phosphating operations are outside the scope of the F019 listing.

An interpretive rule presents administrative and technical difficulties. A revision to the listing will require a rulemaking process. See response to comment (1) above.

(3) Automobile assembly facilities outside of Michigan would like to take advantage of the precedent set by this expedited delisting project to delist F019 generated by similar operations in other states and regions.

The Agency believes that the expedited delisting procedures and requirements set forth in this proposal are appropriate for similar automotive assembly facilities outside the State of Michigan, subject to the discretion of the regulatory agency (state or region).

(4) Alternatives to landfilling like recycling should be allowed within the petition process.

The Agency does not delist wastes which are recycled because the model used to estimate risk is based only on disposal of waste in a Subtitle D landfill. The risk which might result from any other scenario is not evaluated by the delisting program. However, the Agency encourages safe recycling, and variances and exclusions from the definition of solid and hazardous wastes are available for wastes which are recycled.

(5) Analytical methods should be specified in the pre-approved common sampling plan instead of requiring each participant to submit a site-specific list of methods.

Allowing the petitioner to choose an analytical method which meets the data quality objectives specific to the delisting petition provides flexibility. Data quality objectives will vary depending on the allowable levels which are a function of the volume of petitioned waste. The Agency believes that the flexibility of performance based methods results in better data.

(6) Detection limits should not be required prior to sampling since they cannot be adequately predicted without a way to estimate matrix effects.

Although matrix effects cannot be assessed in advance of laboratory analysis, a laboratory should be able to provide estimated detection levels and reporting levels which are lower than, or at least equal to, the allowable delisting level for each constituent.

(7) Since the process generating the sludge is extremely stable, verification sampling should be conducted on an annual, instead of quarterly, basis. The requirement that any process change be promptly reported and the exclusion suspended until EPA gives written approval that the delisting can continue is an adequate safeguard justifying the decrease in sample event frequency.

Verification data submitted in conjunction with past delistings of this waste have shown significant variation on a quarterly basis over longer periods of time. Annual sampling would not detect such variations. Once enough verification data are collected to support a statistical analysis, a change in the frequency of verification sampling and/or sampling parameters may be considered.

(8) The final Federal Register should make it clear that assembly plants that manufacture light trucks are also eligible for the project.

Today's notice specifically defines eligible facilities as inclusive of manufacturers of light trucks.

(9) The table of maximum allowable levels in the March 7, 2002 proposed rule contains errors in the columns for vinyl chloride.

The error was caused by a missing space or tab in the table. Although vinyl chloride was not detected in the waste at any of the six facilities, the maximum allowable concentrations proposed for 1,000 cubic yards of waste should have been a total of 178 milligrams per kilogram (mg/kg) and 0.00384 milligrams per liter (mg/L) in the TCLP. For 2,000 cubic yards of waste, 115 mg/kg total and 0.00234 mg/L TCLP were proposed. For 3,000 cubic yards of waste, 89.4 mg/kg total and 0.00175 mg/L TCLP were proposed.

Today the EPA is finalizing exclusions to conditionally delist wastewater treatment plant sludge from conversion coating on aluminum generated at the following facilities: (1) General Motors Corporation, Pontiac East Plant, in Pontiac, Michigan (3,000 cubic yards annually); (2) General Motors Corporation, Hamtramck Plant, in Detroit, Michigan (3,000 cubic yards annually); (3) General Motors Corporation, Flint Truck, in Flint, Michigan (3,000 cubic yards annually); (4) General Motors Corporation, City of Lansing, and Trigen/Cinergy-USFOS of Lansing LLC, Lansing Grand River Plant, in Lansing, Michigan (2,000 cubic yards annually); (5) Ford Motor Company, Wixom Assembly Plant, in Wixom, Michigan (2,000 cubic yards annually); and (6) Ford Motor Company, Michigan Truck/Wayne Integrated Stamping and Assembly Plant, in Wayne, Michigan (2,000 cubic yards annually).

On March 7,2002, EPA proposed to exclude or delist these wastewater treatment sludges from the list of hazardous wastes in 40 CFR 261.31 and accepted public comment on the proposed rule (67 FR 10341). EPA considered all comments received, and for reasons stated in both the proposal and this document, we believe that these wastes should be excluded from hazardous waste control.

The facilities must dispose of the waste in a lined Subtitle D landfill which is permitted, licensed, or registered by a state to manage industrial waste. The facilities must verify on a quarterly basis that the concentrations of the constituents of concern do not exceed the allowable levels set forth in this exclusion by obtaining and analyzing a representative sample of the waste according to the current waste analysis plan modified to include the improved methodologies discussed in section III. B.

The list of constituents for verification is a subset of those initially tested for and is based on the occurrence of constituents at the majority of facilities and the concentrations relative to the allowable levels. Since all the facilities include significant amounts of nickel in the leachate and nickel combines with thallium targeting the liver and cadmium targeting the kidney, the total hazard index from nickel and thallium combined and/or nickel and cadmium combined shall not exceed 1.0.

This exclusion applies only to the maximum annual volumes cited in section V.A. of this preamble and is effective only if all conditions contained in this rule are satisfied.

This rule is effective July 30, 2003. The Hazardous and Solid Waste Amendments of 1984 amended section 3010 of RCRA to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. This rule reduces rather than increases the existing requirements and, therefore, is effective immediately upon publication under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d).

Today's exclusion is being issued under the federal RCRA delisting program. Therefore, only states subject to federal RCRA delisting provisions would be affected. This exclusion is not effective in states which have received authorization to make their own delisting decisions. Also, the exclusion may not be effective in states having a dual system that includes federal RCRA requirements and their own requirements. EPA allows states to impose their own regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA. These more stringent requirements may include a provision that prohibits a federally issued exclusion from taking effect in the state. Because a dual system (that is, both federal (RCRA) and state (non-RCRA) programs) may regulate a petitioner's waste, we urge petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.

EPA has also authorized some states to administer a delisting program in place of the federal program, that is, to make state delisting decisions. Therefore, this exclusion does not apply in those authorized states. If a participating facility transports the petitioned waste to or manages the waste in any state with delisting authorization, it must obtain a delisting from that state before it can manage the waste as nonhazardous in the state.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), these rules are not of general applicability and therefore are not regulatory actions subject to review by the Office of Management and Budget. Because these rules are each of particular applicability relating to a particular facility, they are not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202, 204, and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Because each of the rules will affect only a particular facility, each rule will not significantly or uniquely affect small governments, as specified in section 203 of UMRA, or communities of tribal governments, as specified in Executive Order 13175 (65 FR 67249, November 6, 2000). For the same reason, each rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). These rules also are not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because they are not economically significant.

These rules do not involve technical standards; thus, the requirements of section 12(c) 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 these rules, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. These rules do 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 Congress and to the Comptroller General of the United States. EPA will submit a report containing these rules and other required information to the U.S. Senate, the U.S. House of Representatives, the Comptroller General of the United States prior to publication of the final rule in the Federal Register . Each of these rules is not a “major rule” as defined by 5 U.S.C. 804(2). These rules will become effective on the date of publication in the Federal Register .

EPA has established an official public docket for this action under Docket ID No. RCRA-1998-0015. The official public docket is the collection of materials that is available for public viewing at the OSWER Docket in the EPA Docket Center (EPA/DC), EPA West Building, Room B102, 1301 Constitution Ave NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OSWER Docket is (202) 566-0270.

You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified above. Once in the system, select “search” and then key in the appropriate docket identification number.

These regulations are issued under the authority of sections 1004, 1006, 2002(a), 3001 through 3007, 3010, 3013, 3014, 3016 through 3018, and 7004 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act, and as amended by the Used Oil Recycling Act, as amended, 42 U.S.C. 6901, 6905, 6912(a), 6921 through 6927, 6930, 6934, 6935, 6937 through 6939 and 6974.

Today's final rule reinstates, with some modifications, three amendments to the RCRA used oil management standards of 40 CFR Part 279. These amendments were issued on May 6, 1998 as a direct final rule, but were retracted on July 14, 1998 because of adverse public comment to the amendments (see 63 FR 24963 and 63 FR 25006). One of the withdrawn amendments, applicability of the used oil management standards to PCB contaminated used oil, was a clarification of the applicability of the RCRA used oil management standards to PCB contaminated used oil. This clarification was undertaken as part of a settlement agreement to resolve a lawsuit challenging a final rule promulgated on May 3, 1993, (58 FR 26420) regarding EPA's used oil regulations. Edison Electric Institute v. U.S. EPA (D.C. Circuit No. 93-1474). Specifically, the May 1993 rule corrected technical errors and provided clarifying amendments to the used oil management standards promulgated on September 10, 1992 (57 FR 41566). The other amendments reinstated today clarify (1) that mixtures of conditionally exempt small quantity generator (CESQG) waste and used oil are subject to the used oil management standards irrespective of how that mixture is to be recycled and (2) that the initial marketer of used oil that meets the used oil fuel specification need only keep a record of a shipment of used oil to the facility to which the initial marketer delivers the used oil.

Today's rule amends 40 CFR 279.10(i) to clarify the applicability of the RCRA used oil management standards to used oil containing PCBs. The amendment clarifies that used oil that contains less than 50 ppm of PCBs is generally subject to regulation under the RCRA used oil management standards. However, the amendment notes that the Toxic Substances Control Act (TSCA) prohibition against the dilution of PCB concentrations below regulatory thresholds (40 CFR 761.1(b)(5)) applies to the dilution of PCB-containing used oil. Used oil, therefore, that contains, or contained prior to dilution, 50 ppm or greater of PCBs is not subject to regulation under the RCRA used oil management standards, because the TSCA regulations at 40 CFR Part 761 provide comprehensive management of such used oil.

For used oil that contains PCB concentrations of 2 ppm or greater, but less than 50 ppm (other than those diluted to below 50 ppm), TSCA regulates the burning of used oil for energy recovery at 40 CFR 761.20(e). Such used oil is also regulated under the RCRA used oil management standards at 40 CFR Part 279. Table 1 shows the applicability of the RCRA and TSCA regulations as they pertain to used oil containing PCBs that is to be burned for energy recovery. Please note, under the TSCA regulations at 40 CFR 761.20(e)(2), used oil that is to be burned for energy recovery is presumed to contain 2 ppm or greater of PCBs unless shown otherwise by testing or other information. Used oil that is to be burned for energy recovery and has been shown to contain less than 2 ppm PCBs (if it has not been diluted) is subject to record keeping and retention requirements under TSCA (40 CFR 761.20(e)(2), (e)(4)) and is regulated under the RCRA used oil management standards. TSCA regulations prohibit the burning for energy recovery of used oil that contains (or contained prior to dilution) PCB concentrations of 50 ppm or greater (40 CFR 761.20(a)).

Used oil containing less than 50 ppm PCBs that is recycled in a manner other than being burned for energy recovery is generally excluded from TSCA requirements except where: (1) Used oil was diluted to below 50 ppm PCBs, or (2) the PCB containing used oil or source of the PCB-containing used oil to be recycled was not legally manufactured, processed, distributed in commerce or used under TSCA. See 40 CFR 761.3 (definition of “excluded PCB products”); 761.20(a)(1); and 761.20(c). However, 40 CFR 761.20(d) of the TSCA regulations prohibits the use of used oil that contains any detectable concentration of PCBs as a sealant, coating, or dust control agent. This prohibition specifically includes road oiling and general dust control. Use of used oil as a dust suppressant is also prohibited under RCRA except in a state that has received authorization from EPA to allow use of used oil as a dust suppressant. Currently no states have received such authorization. In the event that a state were authorized to use used oil as a dust suppressant pursuant to 40 CFR 279.82, the prohibition in 40 CFR 761.20(d) would still apply, however.

The Agency received comment on the May 6, 1998 proposal (63 FR 24963) related to the applicability of the dilution prohibition of 40 CFR 761.1(b)(5) to used oil that contains PCBs. One commenter raised a concern that the May 6, 1998 proposal was unclear as to how PCB-contaminated used oils that have been diluted (below either the 50 ppm or 2 ppm TSCA PCB regulatory thresholds) are regulated.

Used oil that contains PCBs may not be diluted under TSCA to avoid a particular regulatory requirement unless otherwise specifically provided by the TSCA regulations. The TSCA PCB regulations at 40 CFR 761.1(b)(5) prohibit the dilution of PCBs to avoid regulatory requirements. This prohibition is repeated in the definition of “excluded PCB products” in 40 CFR 761.3. Accordingly, used oil that contained PCB concentrations greater than or equal to 50 ppm and that was subsequently diluted to a concentration of less than 50 ppm PCBs, is still regulated under TSCA as used oil that contains a PCB concentration of 50 ppm or greater. This diluted used oil is subject to comprehensive management under TSCA and, therefore, is not regulated under the RCRA used oil management standards. Likewise, used oil that contained a maximum PCB concentration of 2 ppm or greater, but less than 50 ppm, which is subsequently diluted to a concentration of less than 2 ppm, is still regulated under TSCA as used oil that contains a concentration greater than 2 ppm PCBs. (Note, however, that used oils of unknown concentration can be mixed with other such used oils in a common container and subsequently tested to determine if it is less than 2 ppm PCB. See 40 CFR 761.20(e)(2) and 761.60(g)(2)).

The TSCA regulations do allow, however, for the decontamination of used oil at PCB concentrations of 50 ppm or greater to a concentration below 2 ppm if specified decontamination methods ( e.g. , filtering) are used. Such decontaminated used oil is exempt from most TSCA management standards (other than 40 CFR 761.20(e)(2), (e)(4) and 761.79(f)) and is regulated under the RCRA used oil management standards. See 40 CFR 761.79(a)(3) and 761.79(b).

There has been confusion in the regulated community that the presence of PCBs in used oil is one of the criteria for determining whether a used oil fuel subject to the RCRA used oil management standards meets the fuel specification standard such that it may be burned for energy recovery without further regulation under RCRA. In fact, one of the comments received in response to the May 6, 1998 proposal implied that used oil that contains PCB concentrations of 2 ppm or greater, but less than 50 ppm is off-specification used oil due to its PCB content. This is incorrect. As described above, the concentration of PCBs in used oil is relevant to determining whether a used oil is subject to the RCRA used oil management standards. However, for those used oils subject to the RCRA used oil management standards, the presence of PCBs is not one of the criteria for determining whether a used oil fuel meets the used oil fuel specification.

However, used oil that contains PCB concentrations of 2 ppm or greater, but less than 50 ppm, and is burned for energy recovery is also subject to requirements under the TSCA PCB regulations, specifically 40 CFR 761.20(e). These TSCA requirements incorporate by reference certain RCRA Part 279 “off-specification” used oil requirements. (See the discussion below for an explanation of the regulation of PCB-containing used oil that is burned for energy recovery.)

The RCRA used oil specification criteria are set forth at 40 CFR 279.11. The specification criteria establish which used oil fuels may be burned in nonindustrial burners without regulation under RCRA. The used oil fuel specification sets maximum allowable limits for arsenic, cadmium, chromium, lead, and total halogens, as well as a minimum flash point. Although the PCB regulations promulgated pursuant to TSCA are referenced in a note to Table 1 in § 279.11, the presence of PCBs in used oil is not one of the criteria for determining whether used oil that is to be burned for energy recovery meets the fuel specification for purposes of RCRA regulation.

Used oil that is to be burned for energy recovery and that meets the RCRA fuel specifications of § 279.11 (“on-specification” used oil) is not regulated under the authority of Part 279 provided that: (1) Certain conditions for used oil fuel marketers are met, and (2) the used oil is not mixed or contaminated with hazardous waste. (Applicable on-specification used oil fuel marketer requirements can be found at §§ 279.72, 279.73, and 279.74(b).) This is the case, notwithstanding that a used oil fuel may contain PCBs. Although the RCRA regulations do not identify the presence of PCBs in used oil as relevant to the determination of whether the used oil is on- or off-specification, the presence of PCBs in used oil is relevant for determining the applicability of the TSCA regulations for the burning of used oil.

The TSCA rules (specifically, 40 CFR 761.20(e)(2)) establish a presumption that detectable quantities of PCBs are present in used oils to be burned for energy recovery. The presumption can be overcome if a marketer determines through testing or other specified procedures that the used oil fuel does not contain quantifiable levels (2 ppm) of PCBs. TSCA rules found at 40 CFR 761.20(a) also prohibit burning for energy recovery of used oil that contains (or contained prior to dilution) PCBs at concentrations of 50 ppm and greater. In addition, §§ 761.1(b)(5) prohibits dilution to attain PCB concentrations either below 50 ppm or below 2 ppm. (However, see decontamination provisions at 40 CFR 761.79(a)(3) and 761.79(b).)

The TSCA regulations establish requirements for the marketing and burning for energy recovery of used oils containing detectable quantities of PCBs at concentrations of 2 ppm or greater, but less than 50 ppm (40 CFR 761.20(e)). Some of these requirements are incorporations by reference of Part 279 requirements for the marketing and burning for energy recovery of off-specification used oil. Therefore, by operation of the TSCA rules, used oil that is on-specification under the RCRA rules may nevertheless be subject to certain requirements specified in the RCRA rules for off-specification used oil.

Specifically, for used oil burners, the TSCA rules reference some of the RCRA off-specification burner requirements of Part 279 Subpart G, including restrictions on burning, notification requirements, tracking requirements, certification requirements and record keeping requirements. (See 40 CFR 761.20(e)(3)-(4)). For used oil marketers, the TSCA rules, with limited exceptions, restrict marketing to qualified incinerators, to marketers who market off-specification used oils, and to off-specification burners as defined in the RCRA Part 279 regulations (See 40 CFR 761.20(e)(1)). The TSCA rules also reference the RCRA regulatory provisions for marketers in Part 279 Subpart H, including record retention, notification, tracking, and certification. The fact that the TSCA rules incorporate by reference these RCRA standards does not by itself mean that PCB-containing used oil is regulated under RCRA authority or that such used oil is off-specification as defined by Part 279.

Today's rule harmonizes the applicability of 40 CFR Part 261 and Part 279 to mixtures of conditionally exempt small quantity generator (CESQG) waste and used oil that are to be recycled. Specifically, the rule makes clear that mixtures of CESQG waste and used oil that are to be recycled are regulated as used oil under the used oil management standards. Notwithstanding EPA's regulatory intent, the CESQG provision, 40 CFR 261.5(j), that references the applicability of the used oil management standards to mixtures of CESQG waste and used oil that are to be recycled, appears to limit the applicability of the used oil management standards to mixtures that are to be recycled by burning for energy recovery. Section 261.5(j), therefore, incorrectly suggests that mixtures of CESQG wastes and used oil that are to be recycled in a manner other than by burning for energy recovery, such as by re-refining, would not be subject to the used oil management standards. Indeed, because CESQG wastes are not regulated as hazardous wastes, § 261.5(j) would suggest that such mixtures that are re-refined would not be subject to regulation under RCRA Subtitle C or the used oil management standards.

The used oil management standards, however, apply to used oil to be recycled irrespective of what form of recycling is to be employed. By its terms, the presumption in 40 CFR 279.10(a) that used oil is to be recycled (such that used oil is presumptively subject to the used oil management standards, unless it is disposed or sent for disposal), encompasses any type of recycling. The recycling presumption does not, for instance, condition the applicability of the used oil management standards on whether used oil is recycled by burning for energy recovery or by re-refining. Since Part 279 applies to used oil that is to be recycled without regard to how the used oil is to be recycled, Part 279 also applies to mixtures of used oil and CESQG wastes that are to be recycledirrespective of how that mixture is to be recycled.

The apparent limitation contained in § 261.5(j), which would limit the applicability of the used oil management standards to mixtures to be burned for energy recovery, is an artifact of the pre-1992 used oil regulations at 40 CFR Part 266, which only regulated the burning of used oil. When the expanded used oil management standards were promulgated on September 10, 1992, the Agency inadvertently failed to amend § 261.5(j) to reflect the broader scope of the new Part 279. Indeed, the corresponding provision in Part 279 that addresses mixtures of CESQG wastes and used oil to be recycled, § 279.10(b)(3), does not contain the apparent limitation found in § 261.5(j) that would limit the applicability of the used oil management standards to mixtures to be burned for energy recovery. Therefore, today's rule amends § 261.5(j) as it should have been amended in 1992 to reflect the greater scope of Part 279 and to eliminate any potential ambiguity over the applicability of the used oil management standards to mixtures of CESQG wastes and used oil to be recycled. This amendment does not impose additional regulatory requirements on this category of CESQG waste. These wastes have been and continue to be regulated under 40 CFR 279.10(b)(3).

The Agency received one comment opposing this amendment from a state in response to the May 6, 1998 proposal. The comment stated that mixtures of conditionally exempt small quantity generator (CESQG) waste and used oil should only be regulated as used oil if it is to be recycled by burning for energy recovery. This comment opens up the merits of the original rule (§ 279.10(b)(3)) and that is not the intent of today's final rule. Today's final rule intends only to make certain conforming changes to § 261.5(j) to correctly reflect EPA's original intent in the September 10, 1992 Part 279 used oil management standards rule. EPA addressed the merits of the original rule in that previous rulemaking and EPA is not reopening that issue in this final rule. Even if EPA were to reopen this issue in today's rulemaking and to address the merits of this issue, EPA would come to the same conclusion as it did in the previous rulemaking. EPA is not aware of any reason for distinguishing used oil being burned for energy recovery from used oil being recycled in other ways, and the commenter did not provide any. Notwithstanding this clarification of the federal regulations, the state may regulate mixtures of CESQG waste and used oil more stringently than the federal used oil management program.

Today's rule amends 40 CFR 279.74(b) to clarify that the marketer who first claims that used oil that is to be burned for energy recovery meets the fuel specification (on-specification used oil) must only keep a record of a shipment of used oil to the facility to which the initial marketer delivers the used oil. The preamble to the November 29, 1985 rule (50 FR 49164 at 49189) clearly describes the agency's intent to only track on-specification used oil that is to be burned for energy recovery one step beyond the initial marketer. When these recordkeeping requirements were recodified at 40 CFR 279.74(b) (57 FR 41566, September 10, 1992), the regulations required that a marketer must keep a record of each shipment of used oil to an on-specification used oil burner. However, the marketer who first claims that used oil that is to be burned for energy recovery meets the fuel specification might choose not to market the used oil directly to an on-specification used oil burner ( i.e. a non-industrial oil burner). Instead, the on-specification used oil might be marketed to a fuel oil distributor for subsequent sale as fuel oil. In this situation, § 279.74(b) could be interpreted to require the initial marketer of the on-specification used oil to keep a record of all subsequent shipments of that used oil until the on-specification used oil reaches a used oil burner. Today's rule clarifies that the initial marketer of on-specification used oil must only keep a record of a shipment of used oil to the facility to which the initial marketer delivers the used oil. The initial marketer need not keep a record of any subsequent transfers of this used oil. For example, the initial marketer would need to keep a record of a shipment of on-specification used oil to a fuel oil distributor, but the initial marketer would not need to keep records of shipments of this used oil from the fuel oil distributor to fuel oil burners or other fuel oil distributors.

The Agency received one comment opposing this amendment from a state in response to the May 6, 1998 proposal. The commenter was concerned that the proposed amendment does not require tracking of used oil that meets the used oil fuel specification to the point to which it is burned for energy recovery, and thus does not provide adequate protection. The Agency disagrees with this comment. This comment opens up the merits of the original November 29, 1985 rule and that is not the intent of today's rule. As with the issue above discussing mixtures of CESQG waste and used oil, the Agency is not reopening the merits of this issue, because the Agency addressed the merits of this issue in the preamble to the November 29, 1985 rule (50 FR 49164 at 49189). Today's amendment does not represent a change in the requirements, but only clarifies the Agency's intent that only the initial marketer of on-specification used oil must keep a record of each shipment of used oil to the facility to which it delivers the used oil. In the September 23, 1991 supplemental notice of proposed rulemaking (56 FR 48000), EPA did not propose to change the tracking requirements or the management requirements, originally promulgated in 1985 for used oil that meets the used oil fuel specification. In drafting the 1992 rule, EPA only intended to recodify the tracking requirements from the now superseded Part 266. It has always been the Agency's position that used oil that is to be burned for energy recovery that meets the used oil fuel specification is a commodity that will be properly handled like any other fuel. The Agency has always intended that used oil that is to be burned for energy recovery only be regulated under the Used Oil Management Standards until it has been determined to meet the used oil fuel specification. Once it has been determined to meet the fuel specification and the marketer complies with 40 CFR 279.72, 279.73, and 279.74(b), the used oil is no longer regulated by the Used Oil Management Standards. If the used oil is not burned for energy recovery and is recycled by other means or disposed, it is regulated as used oil under the Used Oil Management Standards. Even if the Agency were to address the merits of this issue, we would continue to take the position as we are taking in today's amendment, because, for the reasons discussed above, the Agency believes that the tracking requirements would provide adequate protection. The commenter has provided no new information or arguments that would lead us to change this long-standing position. Notwithstanding this clarification of the federal regulations, a state may regulate used oil more stringently than the federal used oil management program.

Under section 3006 of RCRA, EPA may authorize a qualified State to administer and enforce a hazardous waste program within the State in lieu of the federal program, and to issue and enforce permits in the State. Following authorization, the state requirements authorized by EPA apply in lieu of equivalent Federal requirements and become Federally-enforceable as requirements of RCRA. EPA maintains independent authority to bring enforcement actions under RCRA sections 3007, 3008, 3013, and 7003. Authorized states also have independent authority to bring enforcement actions under state law.

A state may receive authorization by following the approval process described in 40 CFR part 271. Part 271 of 40 CFR also describes the overall standards and requirements for authorization. After a state receives initial authorization, new Federal regulatory requirements promulgated under the authority in the RCRA statute which existed prior to the 1984 Hazardous and Solid Waste Amendments (HSWA) do not apply in that state until the state adopts and receives authorization for equivalent state requirements. The state must adopt such requirements to maintain authorization. In contrast, under RCRA section 3006(g), (42 U.S.C. 6926(g)), new Federal requirements and prohibitions imposed pursuant to HSWA provisions take effect in authorized states at the same time that they take effect in unauthorized States. Although authorized states still are required to update their hazardous waste programs to remain equivalent to the Federal program, EPA carries out HSWA requirements and prohibitions in authorized states, including the issuance of new permits implementing those requirements, until EPA authorizes the state to do so. Authorized states are required to modify their programs only when EPA promulgates Federal requirements that are more stringent or broader in scope than existing Federal requirements.

RCRA section 3009 allows the states to impose standards more stringent than those in the Federal program. See also 40 CFR 271.1(i). Therefore, authorized states are not required to adopt Federal regulations, either HSWA or non-HSWA, that are considered less stringent.

Today's rule corrects and clarifies the scope of certain regulatory requirements and is, therefore, considered to be no more stringent than the existing federal standards. Authorized States are only required to modify their programs when EPA promulgates federal regulations that are more stringent or broader in scope than the existing federal regulations. Therefore, States that are authorized for the used oil management standards are not required to modify their programs to adopt today's rule. However, EPA strongly urges States to do so.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether this regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines “significant” regulatory action as one that is likely to lead to a rule that may:

(1) Have an annual effect on the economy of $100 million or more, or adversely and materially affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities;

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

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

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

It has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.

This action does not impose any new information collection burden since it does not represent any change in requirements, but only clarifies the Agency's intent with respect to certain provisions in the Used Oil Management Standards. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations (40 CFR Part 279) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2050-0124 (EPA ICR No. 1286.06).

Copies of the ICR document(s) may be obtained from Susan Auby, by mail at the Office of Environmental Information, Collection Strategies Division; U.S. Environmental Protection Agency (2822); 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, by email at auby.susan@epa.gov , or by calling (202) 260-4901. A copy may also be downloaded off the internet at http://www.epa.gov/icr . Include the ICR and/or OMB number in any correspondence.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, I certify that today's rule will not have a significant economic impact on a substantial number of small entities. Today's rule will not impact any small entity because it does not impose regulatory requirements or otherwise substantively change existing requirements. The rule eliminates drafting errors and ambiguities in the used oil management standards so as to clarify the Agency's intended result. Even if the rule were viewed as a change, the rule would result in lesser regulatory impact than under existing requirements.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, giving them meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising them on compliance with the regulatory requirements.

Today's rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector because it does not impose regulatory requirements or otherwise substantively change existing requirements. Today's rule eliminates drafting errors and ambiguities in the used oil management standards so as to clarify the Agency's intended result. Even if the rule were viewed as a change, the rule would result in lesser regulatory impact than under existing requirements. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA. Similarly, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

If EPA complies by consulting, Executive Order 13132 requires EPA to provide to the Office of Management and Budget (OMB), in a separately identified section of the preamble to the rule, a federalism summary impact statement (FSIS). The FSIS must include a description of the extent of EPA's prior consultation with State and local officials, a summary of the nature of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which the concerns of State and local officials have been met. Also, when EPA transmits a draft final rule with federalism implications to OMB for review pursuant to Executive Order 12866, EPA must include a certification from the agency's Federalism Official stating that EPA has met the requirements of Executive Order 13132 in a meaningful and timely manner.

This final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it does not impose regulatory requirements or otherwise substantively change existing requirements. Today's rule eliminates drafting errors and ambiguities in the used oil management standards so as to clarify the Agency's intended result. Even if today's rule were viewed as a change, it would result in lesser regulatory impact than under existing requirements. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” Today's rule does not have tribal implications, as specified in Executive Order 13175. Specifically, today's rule does not significantly or uniquely affect the communities of Indian tribal governments because it does not impose regulatory requirements or otherwise substantively change existing requirements. Today's rule eliminates drafting errors and ambiguities in the used oil management standards so as to clarify the Agency's intended result. Even if today's rule were viewed as a change, it would result in lesser regulatory impact than current requirements. Thus, Executive Order 13175 does not apply to this rule.

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

This rule is not subject to Executive Order 13045 because it is not an economically significant rule as defined by Executive Order 12866, and because it does not involve decisions based on environmental health or safety risks.

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

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This proposed rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective September 29, 2003.

Because the regulated community does not need 6 months to come into compliance with this rule, EPA finds, pursuant to RCRA section 3010(b)(1), that this rule can be made effective in less than six months.

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

The 2003 TAC of sablefish for vessels using trawl gear in the Central Regulatory Area of the GOA was established as 1,288 metric tons (mt) by the final 2003 harvest specifications for groundfish in the GOA (68 FR 9924, March 3, 2003).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS, has determined that the allocation of the sablefish TAC assigned to trawl gear in the Central Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that further catches of sablefish by vessels using trawl gear in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the prohibition of retention, lead to exceeding the 2003 TAC of sablefish assigned to vessels using trawl gear in the Central Regulatory Area of the GOA, and therefore reduce the public's ability to use and enjoy the fishery resource.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

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

NMFS manages the groundfish fisheries in the exclusive economic zone of the BSAI under the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Management Area (FMP). The Council prepared the FMP under the authority of the Magnuson-Stevens Act. Regulations governing U.S. fisheries and implementing this FMP appear at 50 CFR parts 600 and 679.

The background regarding this action is detailed in the preamble to the proposed rule published April 25, 2003 (68 FR 20360). Public comments on the proposed rule were invited through May 27, 2003. Background regarding the LLP may be found in the final rule implementing the LLP (63 FR 52642, October 1, 1998).

This action amends the regulatory language at § 679.4(k)(9)(iii)(F) to specify that a person who owns the qualifying harvest history of Pacific cod from a vessel, but who also owned a LLP-qualifying groundfish fishing history from a different vessel at the time the qualifying Pacific cod threshold harvests were made, is eligible for the Pacific cod endorsement on the person's LLP groundfish license. To prevent an increase in the number of LLP groundfish licenses, the regulations also are amended to restrict the LLP qualifying history and the Pacific cod qualifying history of any one vessel to no more than one LLP groundfish license endorsed for Pacific cod hook-and-line and/or pot gear fisheries. This amendment limits the number of vessels allowed to participate in the Pacific cod hook-and-line and/or pot gear fisheries, as intended by the Council in developing the LLP.

The only comment received on the proposed rule is summarized here.

Comment : The author of the comment supports the intent to allow additional participation in the BSAI Pacific cod hook-and-line and pot fisheries, but is concerned that part of the new regulatory amendment would be overly restrictive. The author states that the regulatory amendment would alter the effects of the existing exemptions for eligibility for a Pacific cod endorsement, including the hardship provisions. The language at § 679.4(k)(9)(iii)(F)( 3 ) may be inconsistent with some circumstances of the hardship provision. The author stated that the hardship provisions allow Pacific cod harvested from a single vessel to be used to meet the eligibility criteria for a Pacific cod endorsement on more than one LLP license and that language at § 679.4(k)(9)(iii)(F)(3) may not allow for this application of the hardship provisions.

Response: NMFS has determined that the proposed regulatory language has no effect on the current exemptions for Pacific cod endorsement eligibility or on the “hardship” (unavoidable circumstance) provisions. The current regulation at § 679.4(k)(9)(v)(A) authorizes, in limited instances, the combination of qualifying harvests from a sunken vessel with harvests from a replacement vessel to satisfy the endorsement requirements. This final rule does not change that section. Section 679.4(k)(9)(v)(B), in very limited situations, allows the agency to make conjectures regarding qualifying harvests, for circumstances beyond the applicant's control, if an applicant can demonstrate on the record that qualifying harvests would have been made. This “hardship” provision is not affected by this final rule. This final rule simply clarifies, consistent with Council intent, that the fishing activities of one vessel may not give rise to Pacific cod endorsements on more than one LLP license.

Section 679.4(k)(9)(iii)(F)( 2 ) was changed in the final rule from the proposed rule to improve the clarity of the text. The phrase “by that vessel” was considered redundant and is removed. To clarify the type of endorsement-qualifying harvest history, the words “Pacific cod” were inserted before the text “endorsement-qualifying harvest.” These changes provide clarity and are not substantial.

NMFS prepared a FRFA to evaluate the impact of this action on small entities, in accordance with the provisions of the Regulatory Flexibility Act of 1980, as modified by the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 604(a)). The intentions of this action were explained in the preamble to the proposed rule (68 FR 20360, April 25, 2003).

An IRFA was prepared for the proposed rule and was described in the Classification section of the preamble to the proposed rule. The public comment period ended on May 27, 2003. No comments were received on the economic impacts of the proposed rule.

The entities regulated by this action are those that did not qualify for a Pacific cod endorsement under a final rule published on April 15, 2002 (67 FR 18129), and would qualify under the approach as proposed by the Council in October 2002. According to an analysis prepared to support the Council's October 2002 deliberations, six entities appear to be affected by this action. Two of these are freezer longliners (hook-and-line catcher-processor vessels); one is a pot catcher processor vessel and three are pot catcher vessels. The economic appendix to the 2002 SAFE Report (see ADDRESSES ) indicates that 31 hook-and-line catcher processor vessels active in the BSAI harvesting of Pacific cod were worth less than $3.5 million each in 2001, while 14 harvesting of Pacific cod were worth more than $3.5 million each. All BSAI pot catcher processor vessels and pot catcher vessels are small entities. Thus, about two-thirds of the vessels in this class in the BSAI are small entities. All six entities were treated as small entities for the purpose of this analysis.

This regulation does not impose new recordkeeping or reporting requirements on the regulated small entities.

This action has no adverse economic impacts on these entities. Each of these six small entities would be allowed to claim additional annual harvests to qualify for the BSAI Pacific cod endorsements to the LLP.

A status quo alternative to the action was considered but not adopted. It does not achieve the stated objective of the Council for this action or reduce the potential adverse economic burden on the small entities identified as subject to direct regulation by this action.

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