In an interim rule effective July 11, 2001, and published in the Federal Register on July 17, 2001 (66 FR 37114-37117, Docket No. 99-100-3), we amended the export certification regulations in 7 CFR part 353 regarding the certification of softwood (coniferous) packing materials used with goods exported from the United States to China. The interim rule allowed certification of packing materials that were heat treated in Canada if that treatment was certified by the Canadian Food Inspection Agency to meet requirements established by the Government of the People's Republic of China. These changes were necessary to facilitate the exportation of the large volume of U.S. goods shipped to China using Canadian-origin coniferous solid wood packing materials.

Comments on the interim rule were required to be received on or before September 17, 2001. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

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

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

A proposal to amend 14 CFR part 39 to include an AD for BHTC Model 430 helicopters was published in the Federal Register on October 12, 2001 (66 FR 52072). That action proposed to require, before further flight after March 31, 2002, accomplishing the electrical power distribution system changes in accordance with BHTC Alert Service Bulletin No. 430-01-19, dated February 22, 2001 (ASB).

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or 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.

The FAA estimates that 33 helicopters of U.S. registry will be affected by this AD, that it will take approximately 48 work hours per helicopter to accomplish the changes to the electrical system, and that the average labor rate is $60 per work hour. The manufacturer states in its ASB that the parts will be provided at no cost before March 31, 2002. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $95,040.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

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

On December 7, 2001, the FAA issued Emergency AD 2001-25-51 for MDHI Model MD900 helicopters, which requires performing a dual power confirmation test on the IIDS and inserting a revision to the RFM, as applicable. If the IIDS fails the power test, replacing it is required before further flight. Removing the temporary revision when the IIDS is replaced and inserting the applicable revision into the RFM is also required. That action was prompted by the failure of the IIDS during a helicopter hover operation. The failure was attributed to an error in the manufacturing process and a design deficiency. Failure of the IIDS, if not corrected, could result in the inability to monitor information and warning indications essential for the operation of the helicopter.

The FAA has reviewed MDHI Service Bulletin SB900-081R1, dated November 8, 2001 (SB), which describes procedures for inspecting and replacing the IIDS and inserting revisions into the RFM.

Since the unsafe condition described is likely to exist or develop on other MDHI MD900 helicopters of the same type design, the FAA issued Emergency AD 2001-25-51 to prevent total power failure of the IIDS and the subsequent inability to monitor information and warning indications essential for the operation of the helicopter. The AD requires the following within 10 days:

• Perform an IIDS dual power confirmation test.

• If the IIDS continues to operate after the dual power confirmation test, insert into the RFM the applicable TEMPORARY RFM revisions that state the pilot must “land as soon as possible” after an IIDS failure.

• If the IIDS does not continue to operate, replace it with a specified IIDS before further flight. Insert into the RFM the applicable RFM revision that states the pilot must “land as soon as practical” after total power failure of the IIDS.

• Remove the TEMPORARY RFM revisions when the IIDS is replaced in accordance with this AD, and insert the applicable RFM revision into the RFM.

The actions must be accomplished in accordance with the SB described previously. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability of the helicopter. Therefore, the actions previously described are required as indicated, and this AD must be issued immediately.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual letters issued on December 7, 2001 to all known U.S. owners and operators of MDHI Model MD900 helicopters. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to 14 CFR 39.13 to make it effective to all persons.

The FAA estimates that 53 helicopters of U.S. registry will be affected by this AD. It will take approximately 1 work hour per helicopter to perform the dual power confirmation test and 1 work hour to replace the IIDS, if necessary. The manufacturer has stated in the SB that they will provide replacement IIDS at no cost. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $6360, assuming that the IIDS is replaced on each helicopter.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2001-SW-56-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The Civil Aviation Authority (CAA), which is the airworthiness authority for the United Kingdom, recently notified FAA that an unsafe condition may exist on all British Aerospace Model HP.137 Jetstream Mk.1, Jetstream Series 200, Jetstream Series 3101, and Jetstream Model 3201 airplanes equipped with certain main landing gear (MLG) radius rods.

The CAA reports, that the manufacturer of the MLG radius rods, APPH Ltd., incorrectly heat treated a batch of radius rod cylinders, part number (P/N) 184811. Incorrect heat treatment of the MLG radius rod cylinder causes the part to be below required design strength. This results in reduced structural integrity of the part.

This condition, if not corrected, could result in failure of the MLG. Such failure during takeoff, landing, or taxi operations could lead to loss of airplane control.

We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all British Aerospace Model HP.137 Jetstream Mk.1, Jetstream Series 200, Jetstream Series 3101, and Jetstream Model 3201 airplanes that are equipped with certain MLG radius rods. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on October 5, 2001 (66 FR 50894). The NPRM proposed to require you to inspect the MLG radius rods for the required conductivity or hardness standard, and replace any rod that does not meet this standard.

The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.

After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:

We estimate that this AD affects 250 airplanes in the U.S. registry.

We estimate the following costs to accomplish the inspection using the eddy current conductivity test:

We estimate the following costs to accomplish the inspection using the Rockwell hardness test:

We estimate the following costs to accomplish any necessary replacements that will be required based on the results of the inspection. We have no way of determining the number of airplanes that may need such replacement:

The Federal Office for Civil Aviation (FOCA), which is the airworthiness authority for Switzerland, recently notified FAA of an unsafe condition that may exist on Pilatus Models PC-7, PC-12, and PC-12/45 airplanes. The FOCA reports instances of fuel leaking from the engine-driven pump on the referenced airplanes. The compression set of the gasket and diaphragm after thermal cycling could cause the gasket of the engine-driven pump to extrude between the relief valve housing and the engine-driven pump housing. This in turn relieves the torque of the relief-valve cover screws of the engine-driven pump, which could result in fuel leakage.

Information on the affected pumps follows:

Gasket material extruding from the engine-driven pump housing and relief valve attachment screws with inadequate torque, if not detected and corrected, could lead to fuel leakage and result in a fire in the engine compartment.

We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all Pilatus Aircraft Ltd. Models PC-7, PC-12, and PC-12/45 airplanes that incorporate a certain engine-driven pump. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on October 24, 2001 (66 FR 53738). The NPRM proposed to require you to inspect the joints between the engine-driven pump housing, relief valve housing, and the relief-valve cover for signs of fuel leakage or extruding gasket material; replace any engine-driven pump with signs of fuel leakage or extruding gasket material; and inspect to ensure that the relief valve attachment screws are adequately torqued and re-torque as necessary.

The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.

After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:

We estimate that this AD affects 278 airplanes in the U.S. registry.

We estimate the following costs to accomplish the inspections and re-torque:

We estimate the following costs to accomplish any necessary replacements that will be required based on the results of the inspection. We have no way of determining the number of airplanes that may need such replacement:

Payments of U.S. source income to foreign persons create a number of withholding and information reporting obligations for both the payor and the recipient of these payments under the Internal Revenue Code and associated Treasury regulations. Specifically, under section 871(a), nonresident alien individuals are subject to a 30 percent tax on certain items of income they receive from sources within the United States that are not effectively connected with the conduct of a trade or business in the United States. Those items of income include interest, dividends, royalties, compensation, and other fixed or determinable annual or periodical income. The tax liability imposed under section 871(a) on the payment of such items of income is generally collected by way of withholding at the source pursuant to section 1441(a). Withholding agents are generally required to report payments of such income to the IRS on Form 1042-S.

The 30 percent rate of tax can be reduced under an income tax treaty. Under current Treasury regulations, a withholding agent may generally rely on a Form W-8BEN, “Certificate of Foreign Status of Beneficial Owner for United States Tax Withholding,” or Form 8233, “Exemption From Withholding on Compensation for Independent (and Certain Dependent) Personal Services of a Nonresident Alien Individual,” provided by, or for, the foreign individual certifying eligibility for a reduced rate of tax under an income tax treaty.

Section 1.1441-1(e)(4)(vii) generally provides that a taxpayer identifying number (TIN) must be furnished on a Form W-8BEN or Form 8233 in order for a foreign individual to obtain the benefit of reduced withholding under an income tax treaty. See § 1.1441-6(b)(2)(ii). Treasury and the IRS have recently become aware, however, of certain unusual cases where an unexpected payment to a nonresident alien individual claiming treaty benefits arises on short notice. In general, a foreign individual receiving such an unexpected payment currently may be unable to obtain a TIN prior to payment. In such a case, unless the foreign individual already has a TIN, the withholding agent would be required to withhold tax at the 30 percent rate, rather than the treaty rate, and the foreign individual would be required to file for a refund in order to obtain the benefits of the income tax treaty.

To alleviate this filing burden on foreign individuals, IRS is putting in place administrative procedures that will allow certain withholding agents, who also are acceptance agents (as defined in § 301.6109-1(d)(3)(iv)) and who make unexpected payments to foreign individuals, to apply for and obtain an individual taxpayer identification number (ITIN) for such individuals on an expedited basis. However, Treasury and IRS recognize that, in certain circumstances, these expedited ITIN procedures will not be sufficient to ensure that foreign individuals receiving an unexpected payment can obtain the benefits of a reduced rate of withholding under an income tax treaty at the time of payment. Accordingly, these temporary regulations will allow, in limited circumstances, withholding agents to rely on a Form W-8BEN or Form 8233 that does not include a TIN for purposes of withholding at the reduced treaty rate.

The proposed rules are published elsewhere in this issue of the Federal Register .

These temporary regulations amend § 1.1441-1(b)(7) and § 1.1441-6(b)(1) and add new § 1.1441-6T(h) to provide a limited exception to the requirement that a foreign individual provide a TIN to its withholding agent before obtaining a reduced rate of withholding tax under an income tax treaty. As noted above, under the current regulatory framework, a foreign individual generally is required to put the individual's TIN on the Form W-8BEN or Form 8233 in order to claim a reduced rate of withholding based upon a tax treaty. If a foreign individual does not have a TIN, a withholding agent who is an acceptance agent, as defined in § 301.6109-1(d)(3)(iv), can aid the foreign individual in obtaining an ITIN.

In order to lessen the administrative burden on foreign individuals receiving unexpected payments, the IRS has decided to permit certain withholding agents to enter into special acceptance agent agreements with the IRS that will allow those withholding agents, in their capacity as acceptance agents, to seek ITINs through an expedited process for these foreign individuals claiming treaty benefits. It is anticipated that any withholding agent who qualifies as an acceptance agent under § 301.6109-1(d)(3)(iv) and who anticipates making unexpected payments will be allowed to enter into such an agreement. However, the IRS intends to allow the use of the expedited process only when an application for an ITIN using the standard process will not generate an ITIN in time for the payment.

These temporary regulations provide that, in limited circumstances, a withholding agent who has entered into such a special acceptance agent agreement may rely on a beneficial owner withholding certificate without regard to the requirement that it include a TIN. Generally, these temporary regulations provide that, in order for a withholding agent to rely on a beneficial owner withholding certificate that does not contain a TIN, the withholding agent must be unable to obtain an ITIN for the foreign individual because the IRS is not issuing ITINs at the time of an unexpected payment to the individual or any time prior to the time of payment when the withholding agent had knowledge of the unexpected payment and the nature of the unexpected payment must be such that it cannot reasonably be delayed until the withholding agent could obtain an ITIN for the foreign individual through the use of the expedited process. The temporary regulations further provide that the IRS must receive the foreign individual's application for an ITIN on the first business day following payment. At this time, the IRS intends to issue ITINs through the expedited process from 6 a.m. until 11:30 p.m. E.S.T., except for weekends and holidays. The IRS intends to increase the availability of this expedited process in the future.

Except as provided in these regulations or in § 1.1441-6(c), a foreign individual will continue to be required to provide a TIN on a beneficial owner withholding certificate (Form W-8BEN or Form 8233) in order to obtain the benefit of a reduced rate of withholding under an income tax treaty.

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 has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. These regulations impose no new collection of information on small entities, therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, these temporary regulations will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

The principal author of these regulations is Jonathan A. Sambur, Office of the Associate Chief Counsel (International). However, other personnel from the IRS and Treasury Department participated in their development.

On November 1, 2001, the Coast Guard published a final rule entitled “Certification of Navigation Lights for Uninspected Commercial Vessels and Recreational Vessels” in the Federal Register (66 FR 55086). The final rule, which was to become effective on November 1, 2002, directs manufacturers of uninspected commercial vessels and recreational vessels to install only navigation lights certified and labeled by a laboratory listed by the Coast Guard as meeting the technical requirements of the Navigation Rules.

Upon publication of the final rule, the Coast Guard noted that the implementation date may not provide enough time to complete the testing of navigation lights by laboratories listed by the Coast Guard to allow the recreational boat manufacturers to comply with the regulation. July 2002 is the date most of next year boat models will appear on show room floors. Photo boats for sales brochures will be built in March and April 2002 so that these brochures can be printed in time for the introductions. Actual new model year production will start in April and May 2002. Thus, boat builders must make their navigation light selections for the upcoming model year as early as February 2002. Each navigation light manufacturer will have to make tooling changes to meet the new marking requirements, and many will have to retest their applicable product line. Sufficient time is not available to do this by February 2002. The alternative would be to pull all unsold boats off the market on November 1, 2002, replacing them either with new boat models equipped with compliant navigation lights or modifying their navigation lights to meet the new marking and certification requirements. Most, if not all, agree that this latter alternative is not a reasonable course to take.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. Publishing a NPRM and delaying the rule's effective date would be contrary to the public interest since immediate action is needed to protect the public, ports and waterways of the United States. The Coast Guard will issue a broadcast notice to mariners and written information via facsimile and electronic mail to inform mariners of this regulation.

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

Based on the September 11, 2001, terrorist attacks on the World Trade Center buildings in New York and the Pentagon in Arlington, Virginia, there is an increased risk that subversive activity could be launched by vessels or persons in close proximity to the Port of San Juan, Puerto Rico, against cruise ships entering, departing and moored within this port. There may be Coast Guard, local police department or other patrol vessels on scene to monitor traffic through these areas. Entry into these security zones is prohibited, unless specifically authorized by the Captain of the Port, San Juan, Puerto Rico.

The security zone for a vessel entering the Port of San Juan is activated when the vessel is one mile north of the #1 buoy, at approximate position 18°28.3′ N, 66°07.6′ W, when entering the Port of San Juan. The zone for a vessel is deactivated when the vessel passes this buoy on its departure from the port. The Captain of the Port will also notify the public of these security zones via Marine Safety Radio Broadcast on VHF Marine Band Radio, Channel 22 (157.1 MHz) and Marine Safety Information Bulletins via facsimile and the Marine Safety Office San Juan website at http://www.msocaribbean.com.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979) because vessels should be able to safely transit around the zone and may be allowed to enter the zone with the authorization of the Captain of the Port of San Juan.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because small entities may be allowed to enter on a case by case basis with the authorization of the Captain of the Port.

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

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

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

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

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

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

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

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

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

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

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

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

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

Based on the September 11, 2001, terrorist attacks on the World Trade Center buildings in New York and the Pentagon in Arlington, Virginia, there is an increased risk that subversive activity could be launched by vessels or persons in close proximity to the HOVENSA refinery on St. Croix, USVI against tank vessels and the waterfront facility. Given the highly volatile nature of the substances stored at the HOVENSA facility, this security zone is necessary to decrease the risk that subversive activity could be launched against the HOVENSA facility. The Captain of the Port San Juan is reducing this risk by prohibiting all vessels from coming within 3 miles of the HOVENSA facility unless specifically permitted by the Captain of the Port San Juan or the HOVENSA Facility Port Captain. The Captain of the Port San Juan can be reached on VHF Marine Band Radio, Channel 16 (156.8 Mhz) or by calling (787) 289-2040, 24 hours a day, seven days a week. The HOVENSA Facility Port Captain can be reached on VHF Marine Band Radio channel 11 (156.6 Mhz) or by calling (340) 692-3488, 24 hours a day, seven days a week. The temporary security zone around the HOVENSA facility is outlined by the following coordinates: 64°45′09″ West, 17°41′32″ North, 64°43′36″ West, 17°38′30″ North, 64°43′36″ West, 17°38′30″ North and 64°43′06″ West, 17°38′42″ North.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979) because this zone covers an area that is not typically used by commercial fishermen and vessels may be allowed to enter the zone on a case by case basis with the permission of the Captain of the Port San Juan or the HOVENSA Port Captain.

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

This rule may affect the following entities, some of which may be small entities: owners of small charter fishing or diving operations that operate near the HOVENSA facility. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because this zone covers an area that is not typically used by commercial fishermen and vessels may be allowed to enter the zone on a case by case basis with the permission of the Captain of the Port San Juan or the HOVENSA Port Captain.

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

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

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

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

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

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

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

The Coast Guard has considered the environmental impact of this rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M14475.1D that this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

We 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 relationships between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

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

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

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

2. In person . The Agency has established an official record for this action under docket control number OPP-301208. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of November 14, 2001 (66 FR 57082) (FRL-6808-9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a as amended by the FQPA (Public Law 104-170) announcing the filing of pesticide petitions (PP 9E5037, 1E6326, and 1E6345) for tolerances by Interregional Research Project Number 4 (IR-4), 681 U.S. Highway Number 1, South, North Brunswick, New Jersey 08902-3390. This notice included a summary of the petitions prepared by Dow AgroSciences, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.416 be amended by establishing tolerances for residues of the herbicide ethalfluralin, [ N -ethyl- N -(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)benzenamine, in or on canola seed and safflower seed at 0.05 part per million (ppm).

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for residues of ethalfluralin on canola seed and safflower seed at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances 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 ethalfluralin are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological 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 factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

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

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.416) for the residues of ethalfluralin, in or on a variety of raw agricultural commodities. Tolerances for residues of ethalfluralin are established for dry beans and peas, the Cucurbits vegetable subgroup, peanuts, soybeans, sunflower seeds, and fat, meat, and meat by-products of goats. The tolerance level for all these commodities is 0.05 ppm. Time limited tolerances associated with section 18 requests have also been established for canola and safflower. Risk assessments were conducted by EPA to assess dietary exposures from ethalfluralin in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerance-level residues were used for cucurbit vegetables, canola oil, safflower oil, and goat commodities. All other plant commodities for which there are ethalfluralin tolerances are considered to be blended. For these commodities anticipated residues were used. The ARs used for this analysis are the same as those used for the 1995 reregistration eligibility decision (RED, 3/95) document prepared for ethalfluralin. No percent crop-treated adjustment was made therefore, 100% crop treated was assumed. Further refinements (such as percent crop-treated adjustments and/or Monte Carlo analysis) would yield even lower estimates of acute dietary exposure.

ii. Chronic exposure .In conducting this chronic dietary risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance-level residues were used for cucurbit vegetables, canola oil, safflower oil, and goat commodities. All other plant commodities for which there are ethalfluralin tolerances are considered to be blended. For these commodities anticipated residues were used. The ARs used for this analysis are the same as those used for the 1995 reregistration eligibility decision (RED, 3/95) document. In addition, weighted average percent crop treated data were used for dry beans and peas, melons, cantaloupe, cucumbers, watermelons and soybeans.

iii. Cancer . In conducting this cancer dietary risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII. The following assumptions were made for the cancer exposure assessments: Tolerance-level residues were used for cucurbit vegetables, canola oil, safflower oil, and goat commodities. All other plant commodities for which there are ethalfluralin tolerances are considered to be blended. For these commodities anticipated residues were used. The ARs used for this analysis are the same as those used for the 1995 reregistration eligibility decision (RED, 3/95) document. In addition, weighted average percent crop treated data were used for dry beans and peas, melons, cantaloupe, cucumbers, watermelons and soybeans.

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

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent crop-treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows: 34% of dry beans and dry peas treated; 4% melons and cantaloups treated; 16% cucumbers treated; 15% watermelons treated and 1% soybeans treated.

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

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

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

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

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

Based on the PRZM/EXAMS and SCI-GROW models the EECs of ethalfluralin for acute exposures are estimated to be 2.3 parts per billion (ppb) for surface water and 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 0.05 ppb for surface water and 0.02 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Ethalfluralin is not registered for use on any sites that would result in residential exposure.

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

EPA does not have, at this time, available data to determine whether ethalfluralin 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, ethalfluralin 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 ethalfluralin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

2. Developmental toxicity studies . In the developmental toxicity study in rats, the maternal (systemic) NOAEL was 50 milligram/kilogram/day (mg/kg/day), based on decreased body weight gain and dark urine at the LOAEL of 250 mg/kg/day. The developmental (fetal) NOAEL was 1,000 mg/kg/day (the highest dose tested, HDT).

In the developmental toxicity study in rabbits, the maternal (systemic) NOAEL was 75 mg/kg/day, based on abortions and decreased food consumption at the LOAEL of 150 mg/kg/day. The developmental (fetal) NOAEL was also 75 mg/kg/day, based on a slightly increased number of resorptions, abnormal cranial development, and increased sternal variants at the LOAEL of 150 mg/kg/day.

3. Reproductive toxicity study . In a 3-generation reproductive toxicity study in rats, the parental (systemic) NOAEL was 12.5 mg/kg/day, based on decreased mean body weight gains in males in all generations at the LOAEL of 37.5 mg/kg/day. The reproductive (pup) NOAEL was 37.5 mg/kg/day (the HDT).

In a 7-month multi-generation bridging study in rats, the parental NOAEL of 20 mg/kg/day was based on increased liver weights at the LOAEL of 61 mg/kg/day. The reproductive (pup) NOAEL was 61 mg/kg/day (the HDT).

4. Prenatal and postnatal sensitivity. There is qualitative evidence of increased susceptibility following in utero exposure to ethalfluralin in the developmental toxicity study in rabbits demonstrated by abortions and a slightly increased number of resorptions, abnormal cranial development, and increased sternal variants in the pups. There was no indication of increased susceptibility following in utero exposure to ethalfluralin in the prenatal developmental toxicity study in rats.

5. Conclusion . There is a complete toxicity data base for ethalfluralin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures.

To date, ethalfluralin has not been assessed by the Agency's FQPA Safety Factor Committee. The Agency is in the preliminary stages of evaluating ethalfluralin for an upcoming Tolerance Reassessment Eligibility Decision (TRED) (Reports on FQPA Tolerance Reassessment Progress and Interim Risk Management Decisions). During this reassessment, the Agency's FQPA Safety Factor Committee will evaluate this chemical.

EPA's preliminary review of the studies bearing on risks to infants and children indicates that an additional safety factor of greater than 10X will not be needed to protect the safety of infants and children. Previously, when time-limited tolerances were established for residues of ethalfluralin in or on canola seed and safflower seed to support specific emergency exemptions the Agency concluded that an additional FQPA safety factor of 3X for assessing acute dietary risk and an additional FQPA safety factor of 1X for assessing chronic dietary risk would be adequate for protecting the safety of infants and children. This was based on a determination made by ad hoc FQPA Safety Factor Committee which based its decision on the results of the oral developmental toxicity study in rabbits.

Accordingly, for the purpose of acting on the petition for tolerances for residues of ethalfluralin in or on canola seed and safflower seed prior to completion of the ethalfluralin TRED, the FQPA safety factor of 10X was retained.

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

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

When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to ethalfluralin 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 ethalfluralin on drinking water as a part of the aggregate risk assessment process.

1. Acute risk. An acute dietary endpoint was only identified for females. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to ethalfluralin will occupy less than 1% of the aPAD for females 13 years and older. In addition, despite the potential for acute dietary exposure to ethalfluralin in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of ethalfluralin in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to ethalfluralin from food will utilize less than 1% of the cPAD for the U.S. population and all other population subgroups included in DEEM TM . There are no residential uses for ethalfluralin that result in chronic residential exposure to ethalfluralin. In addition, despite the potential for chronic dietary exposure to ethalfluralin in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of ethalfluralin in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4:

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

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Ethalfluralin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

5. Aggregate cancer risk for U.S. population . Using the exposure assumptions described in this unit for cancer exposure, EPA has concluded that exposure to ethalfluralin from food will result in an estimated lifetime cancer risk to the U.S. population of 5.8 x 10 -7 . Currently there are no uses registered for ethalfluralin that will result in residential exposures. In addition, despite the potential for chronic (cancer) dietary exposure to ethalfluralin in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of ethalfluralin in surface and ground water, EPA does not expect the aggregate exposure to pose greater than a negligible risk (the range of 10 -6 ), as shown in the following Table 5:

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 ethalfluralin residues.

Adequate enforcement methodology (GLC-ECD) is available in PAM II to enforce the tolerance expression. The limit of detection in plant commodities is 0.01 ppm.

There are no Codex maximum residue limits (MRLs) established for ethalfluralin. Mexico has established MRLs of 0.05 ppm in/on squash, cucumber, and melon. Canada has labels for uses on oilseed and pulse crops, wheat, field crop vegetables, barley, rapeseed, flax, canola, and mustard however, there are no published tolerances.

Therefore, tolerances are established for residues of ethalfluralin,[ N -ethyl- N -(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)benzenamine], in or on canola seed and safflower seed at 0.05 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301208 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 March 18, 2002.

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

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

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

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

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

3. Copies for the docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301208, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 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 FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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).

On October 5, 2001, HHS published an interim final rule establishing methods for radiation dose reconstruction to be conducted for certain cancer claims filed under EEOICPA, Public Law 106-398 [See FR Vol. 66, No. 194, 50978]. The notice included a public comment period that ended on November 5, 2001. However, DHHS is requesting the ABRWH to conduct a review of its dose reconstruction methods. ABRWH will be conducting its review during a meeting of the ABRWH scheduled for Tuesday, January 22, 2002 and Wednesday, January 23, 2002.

To permit HHS to consider the ABRWH review and any comments and recommendations of ABRWH in the rulemaking, DHHS will reopen the public comment period. This will also provide the public with the opportunity to participate in this review. The public comment period will be reopened to include the ABRWH meeting transcript and any statements submitted for the record of that meeting in the docket for this rule. DHHS will also accept additional public written comments submitted to its docket office on or before Wednesday, January 23, 2002. The record for this rulemaking will close on Wednesday, February 6, 2002, by which time ABRWH must submit any comments and recommendations on the interim final rule to DHHS.

This rulemaking is required by the Magnuson-Stevens Act (16 U.S.C. 1801 et seq. ) as reauthorized by the Sustainable Fisheries Act, signed into law on October 11, 1996. NMFS published an advance notice of proposed rulemaking (ANPR) in the Federal Register on November 8, 1996 (61 FR 57843) to solicit comments to assist NMFS in developing an approach for the proposed regulations. NMFS published a second ANPR on January 9, 1997 (62 FR 1306) to announce the availability of the “Framework for the Description, Identification, Conservation, and Enhancement of Essential Fish Habitat” (Framework) and to solicit additional public comment. The Framework provided a detailed outline for the proposed regulations. NMFS held 15 public meetings, briefings, and workshops across the nation during the public comment period on the Framework and issued a proposed rule on April 23, 1997 (62 FR 19723). NMFS held an additional 6 public meetings and numerous briefings nationwide during the comment period on the proposed rule and issued an interim final rule on December 19, 1997 (62 FR 66531). The interim final rule took effect on January 20, 1998.

NMFS decided to issue the regulations as an interim final rule in 1997 for two reasons. First, NMFS decided to provide an additional comment period to allow another opportunity for affected parties to provide input prior to the development of a final rule. Second, NMFS determined that it would be advantageous to implement the EFH provisions of the Magnuson-Stevens Act for a period of time via interim final regulations, which would afford an opportunity to gain experience adding EFH information to fishery management plans and carrying out consultations and coordination with Federal and state agencies whose actions may adversely affect EFH. NMFS planned to use the additional comments and its experience implementing the interim final rule to make any necessary changes in the final rule.

The comment period on the interim final rule closed on March 19, 1998 (63 FR 8607, February 20, 1998). On November 8, 1999, NMFS reopened the comment period (64 FR 60731) to announce its intention to proceed with development of a final rule and to request additional public comments on four specific issues: how to improve the regulatory guidance on the identification of EFH; how to improve the regulatory guidance on minimizing the effects of fishing on EFH; whether the final rule should provide additional guidance on using existing environmental reviews to satisfy EFH consultation requirements; and whether to revise in the final rule the requirement for Federal agencies to prepare EFH Assessments as part of the EFH consultation process.

In total, NMFS provided five separate public comment periods for this rulemaking totaling 270 days. NMFS also held numerous public meetings and briefings to explain the EFH requirements for interested parties and to solicit their input. Based on the comments received, as well as NMFS' experience implementing the interim final rule, NMFS identified a number of improvements that would clarify and simplify the regulations. NMFS incorporated those changes in the final rule.

Although NMFS is finalizing this rule, NMFS recognizes that there remains a great deal of interest in the EFH regulations from various stakeholders. There is a diversity of opinions on the best way to integrate habitat and ecosystem considerations into fishery management. NMFS is actively evaluating these issues, and will continue to work with stakeholders to use the best available scientific information regarding habitat and ecosystem principles in fishery management decisions. For example, NMFS will hold a workshop in the coming months to examine the concepts underlying ecosystem-based approaches to marine resource management, followed by a second workshop to develop technical guidelines for implementing an ecosystem-based approach to fishery management. NMFS is also developing new environmental impact statements that will reexamine the EFH sections of many FMPs. NMFS will evaluate the efficacy of the EFH final rule in light of these activities and will apply the lessons learned as appropriate. If further changes to the EFH regulations are warranted, NMFS will propose changes through an appropriate public process.

The final rule retains the same overall structure as the interim final rule, with minor organizational and editorial changes to improve clarity. These clarifications do not constitute substantial changes to the rule. Subpart J of 50 CFR part 600 contains guidelines to assist Councils in developing the EFH components of FMPs. Subpart K of 50 CFR part 600 contains procedures for coordination, consultations, and recommendations for Federal and state agency actions that may adversely affect EFH. NMFS is finalizing both subparts together so that all interested parties will understand the implications of areas being identified as EFH. The final rule contains no major substantive changes from the interim final rule, although the final rule includes numerous clarifications, simplifications, and editorial improvements intended to make the regulations easier to use.

Under subpart J, Councils must identify in FMPs EFH for each life stage of each managed species in the fishery management unit. Councils should organize information on the habitat requirements of managed species using a four-tier approach based on the type of information available. Councils must identify as EFH those habitats that are necessary to the species for spawning, breeding, feeding, or growth to maturity. Councils must describe EFH in text and must provide maps of the geographic locations of EFH or the geographic boundaries within which EFH for each species and life stage is found. Councils should identify EFH that is especially important ecologically or particularly vulnerable to degradation as “habitat areas of particular concern” (HAPC) to help provide additional focus for conservation efforts. Councils must evaluate the potential adverse effects of fishing activities on EFH and must include in FMPs management measures that minimize adverse effects to the extent practicable. Councils must identify other activities that may adversely affect EFH and recommend actions to reduce or eliminate these effects.

Subpart K contains procedures for implementing the EFH coordination, consultation, and recommendation requirements of the Magnuson-Stevens Act. NMFS will make available descriptions and maps of EFH to promote EFH conservation and enhancement. The regulations encourage Federal agencies to use existing environmental review procedures to fulfill the requirement to consult with NMFS on actions that may adversely affect EFH, and they contain procedures for abbreviated or expanded consultation in cases where no other environmental review process is available. Consultations may be conducted at a programmatic and/or project-specific level. In cases where adverse effects from a type of actions will be minimal, both individually and cumulatively, a General Concurrence procedure further simplifies the consultation requirements. The regulations encourage coordination between NMFS and the Councils in the development of recommendations to Federal or state agencies for actions that would adversely affect EFH. Federal agencies must respond in writing within 30 days of receiving EFH Conservation Recommendations from NMFS. If the action agency's decision is inconsistent with NMFS' EFH Conservation Recommendations, the agency must explain its reasoning and NMFS may request further review of the decision. EFH Conservation Recommendations are non-binding.

The final rule modifies portions of the guidelines to Councils for developing the EFH components of FMPs (Subpart J of the rule). Although the changes do not constitute substantial revisions to the guidelines contained in the interim final rule, some of the clarifications and explanations in the final rule result in minor changes to the Secretary's interpretation of the mandatory contents of FMPs. Existing FMP EFH provisions were approved (or in some cases partially approved) by the Secretary pursuant to the interim final rule. Councils are not required to develop immediate amendments to those FMPs to address any changes in regulatory guidelines pursuant to this final rule. To the extent that changes to approved FMPs are necessary to meet the standards of the final rule, Councils should incorporate those changes during the next regular review and revision of FMP EFH provisions. Section 600.815(a)(9) of the final rule (renumbered from § 600.815(a)(11) of the interim final rule) states that Councils should conduct such reviews as recommended by the Secretary, but at least once every five years.

NMFS prepared a draft internal technical guidance manual for EFH in conjunction with the interim final rule. That guidance will be superseded with guidance for the final rule. The draft technical guidance, the Framework, the EA, and other related documents that led to this final rule are available via the internet or by mail upon request (see ADDRESSES ).

NMFS received approximately 3,300 written comments during the two comment periods on the interim final rule. Commenters included Fishery Management Councils, Federal agencies, state agencies, fishery groups, environmental groups, non-fishing industry groups, other non-governmental organizations, academicians, citizens groups, and numerous individuals. The comments and responses discussed below are arranged by topic to parallel the organizational structure of the interim final rule.

Comment A : Several commenters requested that the public comment period be extended and development of the final rule be delayed to allow the public to better assess EFH implementation.

Response A : NMFS disagrees that additional time is needed for public comment. NMFS provided five separate public comment periods on the EFH regulations, for a total of 270 days, which generated more than 3,600 separate written public comments. NMFS published the regulations as an interim final rule for the express purpose of allowing additional comments and gaining experience implementing the EFH provisions of the Magnuson-Stevens Act before issuing a final rule. Since the public comments received during each comment period raised similar issues and concerns with the EFH regulations, NMFS has had ample opportunity to gain understanding of the range of topics and opinions raised by the public and has made many revisions to the EFH regulations to address public comments.

Comment B : Several commenters criticized NMFS for failing to engage non-fishing stakeholders in the development of the EFH regulations and for failing to develop mechanisms to consider non-fishing interests in the EFH regulations.

Response B : NMFS disagrees that non-fishing groups were not given the opportunity to be included in this rulemaking. NMFS held numerous public meetings, briefings, and workshops to engage all interested parties in the development of the EFH regulations and held five separate public comment periods. In addition, NMFS met with every stakeholder group that asked to discuss how the regulations might affect them, including many prominent non-fishing organizations. Many of the changes to the regulations, from the proposed rule to the interim final rule and from the interim final rule to the final rule, responded directly to non-fishing stakeholder concerns.

Comment C : Two commenters requested that NMFS suspend the designation of EFH for Pacific salmon until after final revisions to the EFH regulations are made, since the EFH provisions of the Pacific salmon FMP had not been completed at the time NMFS reopened the comment period on the interim final rule. These commenters also asked NMFS to reopen the comment period on the rule again after the Pacific salmon EFH designations are in effect for a period of time.

Response C : NMFS approved the designation of EFH for Pacific salmon on September 27, 2000 (65 FR 63047). The Magnuson-Stevens Act prescribes a strict time frame for Secretarial action on an FMP amendment following submission by a Council, including an opportunity for public comment on what action the Secretary should take. NMFS cannot delay Secretarial review, and sees no need for another formal comment period on the EFH regulations to gauge implementation of Pacific salmon EFH. Nevertheless, if problems arise related to Pacific salmon EFH, NMFS will address them as appropriate.

Comment D : Several non-fishing industry groups commented that NMFS did not make necessary information on the consultation process available to commenters when the comment period for the interim final rule was reopened in November 1999. Some of these commenters referred specifically to their pending Freedom of Information Act (FOIA) request for copies of documents related to the EFH consultation process and every individual consultation that had occurred to date.

Response D : NMFS' intent in reopening the public comment period on the interim final rule in November 1999 was to solicit comments from interested parties on four specific issues: the scope of EFH designations, documentation of measures to minimize adverse fishing impacts to EFH, the use of existing environmental review procedures for EFH consultations, and the preparation of EFH Assessments (64 FR 60731). NMFS asked commenters to answer based on their individual experience under the interim final rule. NMFS did not request that commenters conduct a program review of the EFH consultation process, nor did NMFS ask for comments on the totality of experience gained through all of the consultations completed thus far. The information requested by the commenters under FOIA was not necessary to enable the commenters to provide answers to NMFS' questions regarding their experience under the interim final rule, and analysis of that information was not a prerequisite to providing informed comments.

Comment E : One commenter noted that the absence of lists of species managed under FMPs and prey species in the proposed and interim final rules made it more difficult to provide meaningful comment on the EFH regulations.

Response E : NMFS determined that providing lists of managed and prey species in the EFH regulations was unnecessary. NMFS' intent in soliciting public comment on the regulations was to seek input on the process of identifying EFH and implementing the other EFH provisions of the Magnuson-Stevens Act, and not on how to identify EFH for specific managed species. Furthermore, the list of managed species changes whenever Councils develop management plans for new species. Nonetheless, the EA that accompanied publication of the interim final rule contained a list of managed species, and this list has been updated in the revised EA. Since the list will continue to change over time, interested parties should contact the Councils to obtain the most updated information on managed species. EFH cannot be designated for non-managed prey species, so a list of such species is not directly relevant to the rule.

Comment F : Several non-fishing groups commented that Fishery Management Councils should include representation of non-fishing interests.

Response F : The Secretary appoints members of each Council from lists of individuals recommended by the Governors of applicable states. Section 302(b)(2)(A) of the Magnuson-Stevens Act states that the appointed members of each Council “must be individuals who, by reason of their occupational or other experience, scientific expertise, or training, are knowledgeable regarding the conservation and management, or the commercial or recreational harvest, of the fishery resources of the geographical area concerned.” There is ample flexibility in this requirement to allow for a broad range of representation on Councils. For example, a rancher from Idaho formerly served as a member of the Pacific Fishery Management Council.

Comment G : One commenter noted that the rule contains no provisions to ensure that non-fishing interests receive timely notification of Council meetings.

Response G : There are ample mechanisms through which interested parties can obtain information regarding Council meetings, and it is unnecessary to ensure such notification in the EFH regulations. Section 302(i) of the Magnuson-Stevens Act requires timely public notice of Council meetings in local newspapers and the Federal Register . All Councils have internet sites, most of which post the schedule and agendas for upcoming meetings. Additionally, interested parties can call Councils directly to receive information on upcoming meetings, and many Councils maintain mailing lists and send agendas to interested parties. NMFS encourages all interested parties to participate in the Council process.

Comment H : Both fishing and non-fishing groups commented that NMFS should engage local stakeholders in the process of EFH identification.

Response H : NMFS agrees and continues to encourage public involvement in EFH identification via the Council process. Section 305(b)(1)(B) of the Magnuson-Stevens Act requires NMFS, in consultation with participants in the fishery, to provide recommendations and information to assist Councils in EFH identification. NMFS typically solicits this input from the public via the Council process. Each Council holds numerous meetings throughout the year that focus on habitat and other issues related to fishery management. These meetings include public scoping meetings and public hearings and are specifically designed to engage interested parties in fishery management decisions, including decisions related to EFH identification. Furthermore, many Councils have habitat advisory panels. NMFS encourages interested parties to seek membership on Council advisory panels.

Comment A : Several non-fishing groups commented that the EFH regulations are too complex, ambiguous, and burdensome.

Response A : NMFS has attempted to improve the clarity of the EFH regulations by eliminating wordiness, increasing specificity of the language, improving the efficiency of certain procedures, and reorganizing several sections. These changes should make the regulations easier to use and should promote better understanding of how to implement the EFH provisions of the Magnuson-Stevens Act. Councils, Federal agencies, and other interested parties should benefit from the modifications that were made to the EFH regulations.

Comment B : Two non-fishing industry groups expressed concern that their comments on the proposed rule were not addressed and asked NMFS to revisit their initial concerns. The comments questioned NMFS' authority to address non-fishing activities and said that the EFH coordination, consultation, and recommendation requirements of the regulations are burdensome and duplicative.

Response B : NMFS considered all comments received on the proposed rule, but did not accept all of the recommendations for changes to the rule. NMFS responded to the cited comments in the preamble to the interim final rule at 62 FR 66539-66540 and 66543. NMFS revisited these concerns while developing the final rule and concluded that, with the exception of changes described herein to clarify and streamline portions of the rule, no additional changes are warranted.

Comment C : One commenter questioned NMFS' approach to implementing the EFH provisions in light of the commenter's concerns about the U.S. Fish and Wildlife Service's efforts to protect bull trout under the Endangered Species Act.

Response C : Bull trout are not managed under the Magnuson-Stevens Act and the commenter's concerns are unrelated to the EFH regulations.

Comment A : Numerous commenters, primarily from conservation groups, expressed concern about the extended comment period and delay in promulgating the final rule, and questioned NMFS' commitment to implementing the EFH regulations. Many commenters urged NMFS to finalize the EFH regulations immediately without weakening them.

Response A : NMFS has been implementing the EFH regulations since January 1998, 30 days following publication of the interim final rule. The final rule benefitted from public comments on ways to improve the EFH regulations, and it incorporates many of the suggestions NMFS received.

Comment B : Several commenters supported the rule but expressed concern that the EFH regulations impose an additional burden on the already heavy workload of NMFS personnel without offering new budgetary or staff resources. These commenters were concerned that resources may be diverted from other priorities to EFH, or that insufficient NMFS staff levels may slow the EFH consultation process.

Response B : NMFS agrees that the EFH mandate will impose additional work on NMFS staff and has taken this into consideration in crafting the final rule to minimize duplication and maximize efficiency. For example, NMFS encourages agencies to use existing environmental review procedures to complete EFH consultations. Additionally, NMFS has created options such as the General Concurrence and programmatic consultations that will help streamline the EFH consultation process. NMFS has redirected staff from other tasks as necessary to fulfill the new requirements of the Magnuson-Stevens Act.

Comment C : Several individuals and organizations from Alaska remarked that the future of fishing in Alaska depends on marine habitat, and thus the rule is important for Alaska fisheries.

Response C : NMFS agrees. The final rule is intended to benefit marine, estuarine, and riverine habitats of federally managed species and help promote sustainable fisheries in Alaska and nationwide.

Comment A : Several commenters questioned NMFS' interpretation of the statutory definition of EFH, wherein NMFS interpreted the meaning of several key terms: “waters,” “substrate,” necessary,” and “spawning, breeding, feeding, and growth to maturity.” Some commenters asked whether, for purposes of identifying EFH, the term “waters” may include wetlands or riparian areas in proximity to waters occupied by a managed species. Other commenters suggested that NMFS remove the interpretation that “waters” and “substrate” can include biological properties, stating that the references to biological features inappropriately expand the definition of EFH. Two commenters thought that the interpretation of “substrate” should explicitly include historically important substrate areas that may have been modified by human activity. One commenter said that the word “structures,” which is part of the interim final rule interpretation of the word “substrate,” should not refer to human-made structures such as oil platforms, but only to natural structures that support fish. Several commenters took the opposite view and wanted the rule to encourage identifying artificial reefs, jetties, and shipwrecks as EFH. Other commenters objected to the narrowed interpretation of “necessary” in the interim final rule and recommended that NMFS return to the approach in the proposed rule where “necessary” meant the habitat required to support a sustainable fishery and a health ecosystem.

Response A : NMFS is not modifying its interpretation of the statutory definition of EFH in the final rule. The final rule retains the language in § 600.805(b)(2) of the interim final rule stating that EFH may be identified in waters of the United States, as defined in 33 CFR 328.3, which includes wetlands. EFH is limited to aquatic areas, so it may not include riparian habitats. As explained in the preamble to the interim final rule at 62 FR 66533, NMFS disagrees that interpreting “waters” and “substrate” to include “biological properties” and “biological communities” respectively is an impermissible expansion of the statutory definition of EFH. Certain biological properties of water and substrate are fundamental components of habitat and are necessary to maintain the function of habitat for fish. NMFS is not modifying the interpretation of “substrate” to discuss historically important substrate areas because the potential identification of historic habitats as EFH is addressed adequately in § 600.815(a) of the rule. NMFS is not modifying the interpretation of “substrate” to exclude human-made structures, because in some cases such structures can provide valuable habitat for managed species. As discussed in the preamble to the interim final rule at 62 FR 66534, structures such as artificial reefs, jetties, and shipwrecks may be identified as EFH in an FMP if they meet the criteria for EFH identification in the rule. The interpretation of “necessary” in the final rule continues to include the clarifying phrase “and the managed species' contribution to” a healthy ecosystem because it would be inappropriate for the rule to suggest that EFH must include habitats for species other than managed fish.

Comment B : Many commenters objected to or asked for clarification of the definition of “adverse effect” in §§ 600.810(a) and 600.910(a). Most of these commenters said the definition is vague and can be interpreted too broadly to include even effects that are of no consequence or significance to EFH. One commenter asked to what extent an activity must reduce the quality and/or quantity of EFH to trigger action. Some commenters thought that the example of a loss of prey being an adverse effect to EFH exceeds the proper interpretation of what constitutes EFH. These commenters felt that prey is not part of EFH so should not be referenced in a definition of “adverse effect.” One commenter recommended that the definition of “adverse effect” in the rule address only statistically significant adverse effects and provide for documentation of probabilities of error when predicting adverse effects. Another commenter focused on the statutory requirement for Federal agencies to consult with NMFS regarding actions that may adversely affect EFH and said NMFS' definition of “adverse effect” illegally negates the statutory duty of other agencies to decide what effects are adverse.

Response B : NMFS is modifying the definition of “adverse effect” in response to comments. The revised definition retains the original standard that an adverse effect is any impact that reduces the quality and/or quantity of EFH. The definition clarifies the types of alterations that may be included and explains that such modifications to habitat are only considered adverse effects if they reduce the quality and/or quantity of EFH. The definition also clarifies that adverse effects to EFH may result from actions occurring within EFH or outside of EFH. NMFS disagrees with the comments that loss of prey is beyond the appropriate scope of adverse effects to EFH. The revised definition specifically mentions the loss of or injury to prey species and their habitats as potential adverse effects to EFH because, as mentioned above, prey can be a vital component of habitat for managed species. NMFS disagrees that only statistically significant adverse effects should be considered because the Magnuson-Stevens Act contains no such limitations. A much more inclusive definition of “adverse effect” is necessary in the regulations to clarify what kinds of potential effects should be addressed in FMPs and in the coordination, consultation, and recommendation process for Federal and state agency actions. Federal agencies retain the discretion to make their own determinations as to what actions may fall within NMFS' definition of “adverse effect.”

Comment C : One commenter said that the definition of “healthy ecosystem” should not say that such areas should be similar to undisturbed ecosystems, because hardly any ecosystem could be characterized as pristine or entirely undisturbed. Another commenter asked for an explanation of the terms “species richness” and “resilience” within the definition of “healthy ecosystem.”

Response C : NMFS does not agree that the regulations should omit the reference to undisturbed ecosystems. The definition of “healthy ecosystem” in the rule refers to comparing ecological features of ecosystems. Saying that healthy ecosystems should be similar to comparable undisturbed ecosystems is intended to convey that the basic functions of such ecosystems have not been altered by anthropogenic events, and not that such ecosystems are entirely pristine. The term “species richness” refers to biodiversity. The term “resilience” refers to the ability of a healthy ecosystem to withstand a certain level of environmental stress yet maintain its ecological functions.

Comment D : One commenter inferred that best professional judgment will be necessary to evaluate available data and identify EFH, and asked for a definition of “best professional judgment” in the final rule. The commenter asked what process NMFS envisions for gathering a range of scientific opinions and how NMFS will overcome the disadvantages of expert panels.

Response D : NMFS decided not to add a definition of “best professional judgment.” The regulations do not specifically call for using such judgments, so a definition is unnecessary. NMFS recognizes that professional opinion must be factored into EFH-related decisions by Councils, Federal agencies, and NMFS, but NMFS sees no need to define a separate process for considering professional opinions related to EFH as opposed to professional opinions on other matters.

Comment E : One commenter said that NMFS had overstepped its authority by referring to EFH “protection” when the Magnuson-Stevens Act uses the words “conservation and enhancement” of EFH.

Response E : NMFS reviewed the EFH regulations carefully to ensure that word usage reflected the intent of the Magnuson-Stevens Act. For instance, language in § 600.815(a)(2)(ii)(A) of the interim final rule was revised in the final rule (now in § 600.815(a)(1)(iv)(A)) to replace “protected” with “identified” as follows: “Councils should interpret this information in a risk-averse fashion, to ensure adequate areas are identified as EFH for managed species.” In other cases, use of the term “protection” was appropriate. For example, § 600.905(a), which reads, “The purpose of these procedures is to promote the protection of EFH in the review of Federal and state actions that may adversely affect EFH” is consistent with section (2)(b)(7) of the Magnuson-Stevens Act, which states that one of the Act's purposes is to “promote the protection of EFH in the review of projects conducted under Federal permits, licenses, or other authorities that affect such habitat.”

Comment A : Numerous commenters endorsed the use of the precautionary principle in identifying EFH. Several said that EFH should be identified for all marine fish species, and not just those managed under an FMP. Other commenters said that EFH designations should consider all relevant ecosystem components, including prey for managed species. A few commenters thought the regulations should call for identifying all areas as EFH until proven otherwise.

Response A : NMFS addressed similar comments from the proposed rule in the preamble to the interim final rule at 62 FR 66534. The Magnuson-Stevens Act requires that each FMP describe and identify EFH, and it is not appropriate to extend this requirement to species not managed under an FMP. NMFS agrees that EFH designations should account for pertinent features of the ecosystem such as prey, as noted in the interpretation of EFH in § 600.10. However, only the habitat necessary to managed species may be considered EFH. The final rule retains language in § 600.815(a) stating that Councils should interpret habitat information in a risk-averse fashion when identifying EFH. NMFS does not agree that all areas should be identified as EFH until proven otherwise, because EFH designations must be based on available scientific information indicating that the specified habitat is necessary for the managed species.

Comment B : Some commenters objected to the interim final rule restricting EFH designations to the outer limits of the U.S. Exclusive Economic Zone (EEZ), and thought that Councils should be required to address adverse effects to EFH in waters beyond the EEZ.

Response B : As explained in the preamble to the interim final rule at 62 FR 66535, areas beyond the EEZ cannot be identified as EFH, and Federal agencies need not consult with NMFS regarding the effects of actions on habitats beyond the EEZ. However, Councils may promote the protection of managed species' habitats outside the EEZ, and NMFS will use that information as appropriate in discussions regarding international actions.

Comment C : One commenter said that NMFS should delete from § 600.805(b) the language saying that a Council may describe, identify, and protect the habitat of species not in a fishery management unit, but such habitat may not be considered EFH. The commenter said that under the Magnuson-Stevens Act, Councils may only develop FMPs for identified species and may not act to describe, identify, or protect the habitat of other species. The commenter also said that Councils have no authority under the Magnuson-Stevens Act to protect the habitat of any fish.

Response C : The preamble to the interim final rule at 62 FR 66534 notes that the Magnuson-Stevens Act does not preclude Councils from identifying habitat (other than EFH) of a fishery resource under its authority even if the species is not managed under an FMP. Council action to protect the habitats of managed or non-managed species is limited to protecting habitats from fishing activities. Councils have no authority to protect habitats from other activities, although they may comment to state and Federal agencies on non-fishing activities under section 305(b)(3) of the Act.

Comment D : One organization commented that the regulations should consider recreationally important species, including the economic value of recreational fisheries, in any actions taken pursuant to the rule.

Response D : NMFS agrees. EFH must be identified for all species in the fishery management unit of an FMP, including recreationally important species. Actions taken by a Council, NMFS, or a Federal or state action agency to address threats to EFH should account for the recreational as well as commercial value of fishery resources dependent on EFH. However, no specific changes to the rule are necessary to provide for consideration of recreational fisheries.

Comment E : A few commenters urged regional flexibility in the regulations so Councils can develop their own EFH designations and procedures for tracking actions that may adversely affect EFH.

Response E : NMFS agrees. The final rule contains national guidelines for Councils but provides sufficient flexibility to account for the variety of managed species and to address regional variations in the availability of scientific information and differences in Council operating procedures nationwide.