Since 1935, upon enactment of the Tobacco Inspection Act, the USDA has provided mandatory inspection services at designated tobacco auction markets. In 2002, based on results of referenda conducted among producers eligible for price support, regulations were amended to provide mandatory inspection at places other than designated tobacco auction markets. The USDA has always sought the input of the industry in implementing legislative authority concerning marketing due to the large geographic areas involved and the different procedure in individual types of tobacco such as size and weight of packages used to display the product, the number of designated markets, the number of sets of buyers present, the number of sales days, and other matters that directly impact on the operation of the auction markets and, therefore, the Federal presence necessary to provide the level of service desired by producers and industry.

In 1974, at the request of the industry, the USDA established the Flue-Cured Tobacco Advisory Committee (FCTAC) to provide a mechanism for consultation with flue-cured producers, warehouse representatives, and buying interests on the problems peculiar to that type of tobacco with particular emphasis on the grower designation program. The composition of the committee was specified in regulations although it was not necessary and is not customary. At a recent meeting, the FCTAC recommended that the regulations referencing its composition and representation be removed. Removal of these regulations will not alter the FCTAC's purpose nor direction for an orderly marketing of tobacco but will allow the USDA more flexibility in making structural changes in its composition as a result of new marketing changes. Historically, almost all flue-cured tobacco was sold at auction. In recent years, most flue-cured tobacco has been sold under contract.

The USDA intends to decrease the FCTAC from 39 members, each with an alternate, to 21 members, each with an alternate. The entities currently represented on the FCTAC will not change. The Flue-Cured Stabilization Cooperation will be added with one member. The rest of the apportionment will change as follows: Georgia, South Carolina, and Virginia Farm Bureaus will decrease from two members each to one member each; North Carolina Farm Bureau will decrease from eight members to four members; North Carolina State Grange will decrease from four members to two members; Tobacco Association of United States will decrease from five members to four members; Bright Belt Warehouse Association will decrease from 10 members to one member; Florida Farm Bureau, South Carolina State Grange, Tobacco Growers Association of North Carolina, Philip Morris USA, R. J. Reynolds Tobacco Company, and Lorillard Tobacco Company will all remain unchanged with one member each.

There are currently regulations at 7 CFR subpart G, §§ 29.9401-29.9407 covering the FCTAC. Section 29.9403 (b), (c), (d), and (e) would be removed.

This rule has been determined to be not significant for purposes of Executive Order 12866, and, therefore, has not been reviewed by the Office of Management and Budget.

This rule has been reviewed under Executive order 12988, Civil Justice Reform. This action is not intended to have retroactive effect. The rule will not exempt any State of local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.

In conformance with the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), full consideration has been given to the potential economic impact upon small business. All tobacco warehouses and producers fall within the confines of “small business: which are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $3,500,000. There are approximately 190 tobacco warehouses and approximately 450,000 tobacco producers and most warehouses and producers may be classified as small entities. The AMS has determined that this action will not have a significant economic impact on a substantial number of small entities. This interim final rule would not substantially affect the normal movement of the commodity into the marketplace. Compliance with this interim final rule would not impose substantial direct economic cost, recordkeeping, or personnel workload changes on small entities, and would not alter the market share of competitive positions of small entities relative to the large entities and would in no way affect normal competition in the marketplace. This rule merely removes section of the regulations that specify composition of the FCTAC.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary and customary to the public interest to give preliminary notice prior to putting this rule in effect, and that good cause exists for not postponing the effective date of this rule until 60 days after publication in the Federal Register so that USDA can utilize the advice of a committee which reflects the current makeup of the tobacco industry during the current marketing season. This interim final rule provides a 60-day comment period, and all comments timely received will be considered prior to the finalization of this rule.

Section 1601(c) of the Farm Security and Rural Investment Act of 2002 (the 2002 Act) requires that the regulations needed to implement Title I of the 2002 Act, including those involved here, are to be promulgated without regard to the notice and comment provisions of 5 U.S.C. 553 or the Statement of Policy of the Secretary of Agriculture effective July 24, 1971, (36 FR 13804) relating to notices of proposed rulemaking and public participation in rulemaking. These regulations are thus issued as final.

This final rule has been determined to be significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget (OMB). A cost-benefit assessment was completed and is summarized after the background section explaining the rule.

This rule has a potential impact on all programs listed in the Catalog of Federal Domestic Assistance in the Agency Program Index under the Department of Agriculture, Farm Service Agency and Natural Resources Conservation Service. Other assistance programs are also impacted.

The Regulatory Flexibility Act is not applicable to this rule because the Commodity Credit Corporation (CCC) is not required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule.

The environmental impacts of this final rule have been considered under the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq. , the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and regulations of the Farm Service Agency (FSA) of the Department of Agriculture (USDA) for compliance with NEPA, 7 CFR part 799. It has been concluded that the rule will have no significant impacts upon the human environment as documented by an environmental evaluation. A copy of the environmental evaluation is available for inspection and review upon request. Therefore, the agency has determined that this rule is a categorical exclusion and no further environmental review is required.

The final rule has been reviewed under Executive Order 12778. This rule preempts State laws that are inconsistent with it, however, this rule is not retroactive. Before judicial action may be brought concerning this rule, all administrative remedies must be exhausted.

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

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) does not apply to this rule because CCC is not required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking about this rule. Also, this rule contains no mandates as defined in sections 202 and 205 of UMRA.

Section 1601(c) of the 2002 Act requires that the regulations necessary to implement Title I of the 2002 Act should be issued within 90 days of enactment and that such regulations shall be issued without regard to the notice and comment provisions of 5 U.S.C. 553. Section 1601(c) also requires that the Secretary use the authority in section 808 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121 (SBREFA), which allows an agency to forgo SBREFA's usual 60-day Congressional review delay of the effective date of a major regulation if the agency finds that there is a good cause to do so. These regulations affect the planting and marketing decisions of a large number of agricultural producers. Accordingly, this rule is effective upon the date of filing for public inspection by the Office of the Federal Register.

Section 1601(c) of the 2002 Act provides that the promulgation of regulations and the administration of Title I of the 2002 Act shall be done without regard to chapter 5 of title 44 of the United States Code (the Paperwork Reduction Act). Accordingly, these regulations and the forms and other information collection activities need to administer the program authorized by these regulations are not subject to review by the Office of Management and Budget under the Paperwork Reduction Act.

The 2002 Act authorized new programs and benefits, including direct payments and counter-cyclical payments. In section 1603 of that Act, by amendment to Section 1001 of the Food Security Act of 1985 (7 U.S.C. 1308), Congress limited the amount of such payments that could be received by one person. The per person payment limits are for direct payments, counter-cyclical payments, marketing loan gains, and loan deficiency payments of $40,000, $65,000, and $75,000 respectively for the “covered commodities” of corn, grain sorghum, barley, oats, wheat, soybeans, minor oilseeds, cotton and rice. Separate limits for comparable peanut payments are set; however, the $75,000 limits for marketing loan gain and loan deficiency payments includes payments for wool, mohair and honey.

The 2002 Act carries over from previous legislation an “actively engaged in farming requirement” and “person” rules for a producer to be eligible to receive program benefits. The definition of “person” includes individuals and also encompasses certain partnerships, corporations and other types of organizations. The 2002 Act establishes per “person” payment limitations for direct payments, counter-cyclical payments, marketing loan gains, and loan deficiency payments for the covered commodities. There are also per “person” payment limitations for the various conservation and environmental programs. Some diversified producers may be able to pool several payment limits from the same program, such as peanuts, which have a limit of $75,000, and corn and soybeans, which have separate payment limits, to earn an additional $75,000 in loan deficiency payments. Plus, this producer could receive $40,000 and $65,000 in direct and counter-cyclical payments from the corn, soybeans and peanuts.

Payment limits are further relaxed by the availability of commodity certificates for marketing assistance repayment. Commodity certificates are available to producers with outstanding recourse marketing assistance loans and may be used by producers or their agents to acquire commodities pledged as collateral for those loans. The producer may purchase a commodity certificate, exchange the certificate for the loan collateral, the loan is considered liquidated, and the producer has no more obligation for that portion of the collateral. Moreover, the payment limit does not apply to any indirect benefit the producer may realize from such a transaction because there is no marketing gain. An eligible producer, however, must have an outstanding commodity loan that has not matured.

In May 2002, the Congressional Budget Office (CBO) estimated that the 2002 Act would change expenditures compared to the previous legislation. They compared two sets of policies using the same commodity prices and macroeconomic variables. CBO found that in fiscal year 2002 through 2006 the new set of payment limits would save $92 million more than the payment limits for programs in previous legislation. This amount does not establish that limits in the 2002 Act are more effective since the available programs have changed. Part of the available savings may be credited to the effects of the limits on the counter-cyclical payments which did not exist under the previous legislation. Contact the information contact list in the address section of this rule for additional questions on the expected impacts.

Section 1601(c) of the 2002 Act requires that the regulations to implement Title I of the 2002 Act are to be promulgated without regard to the notice and comment provisions of 5 U.S.C. 553 or the Statement of Policy of the Secretary of Agriculture effective July 24, 1971, (36 FR 13804) relating to notices of proposed rulemaking and public participation in rulemaking. These regulations are thus issued as final.

This final rule has been determined to be economically significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget (OMB). A cost-benefit assessment was completed and is summarized after the background section explaining the rule.

The title and number of the Federal assistance program, as found in the Catalog of Federal Domestic Assistance, to which this final rule applies are: Commodity loans and loan deficiency payments, 10.051.

The Regulatory Flexibility Act is not applicable to this rule because neither the Secretary of Agriculture nor CCC are required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule.

The environmental impacts of this rule have been considered under the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq. , the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and regulations of the Farm Service Agency (FSA) of the Department of Agriculture (USDA) for compliance with NEPA, 7 CFR part 799. An Environmental Evaluation was completed and it was determined that the proposed action does not have the potential to significantly impact the quality of the human environment and, therefore, the rule is categorically excluded from further review under NEPA. A copy of the environmental evaluation is available for inspection and review upon request.

The final rule has been reviewed in accordance with Executive Order 12778. This final rule preempts State laws that are inconsistent with its provisions, but the rule is not retroactive. Before any judicial action may be brought concerning this rule, all administrative remedies must be exhausted.

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

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) does not apply to this rule because neither the Secretary of Agriculture nor CCC are required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule. Also, the rule imposes no mandates as defined in UMRA.

Section 1601(c) of the 2002 Act requires that the regulations necessary to implement Title I of the 2002 Act must be issued within 90 days of enactment and that such regulations shall be issued without regard to the notice and comment provisions of 5 U.S.C. 553. Section 1601(c) also requires that the Secretary use the authority in section 808 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121 (SBREFA), which allows an agency to forgo SBREFA's usual 60-day Congressional Review delay of the effective date of a major regulation if the agency finds that there is a good cause to do so. Accordingly, this rule is effective upon the date of filing for public inspection by the Office of the Federal Register.

Section 1601(c) of the 2002 Act requires that these regulations be promulgated and the programs administered without regard to the Paperwork Reduction Act. This means that the information to be collected from the public to implement these programs and the burden, in time and money, the collection of the information would have on the public does not have to be approved by the Office of Management and Budget or be subject to the normal requirement for a 60-day public comment period.

CCC is committed to compliance with the Government Paperwork Elimination Act (GPEA) and the Freedom to E-File Act, which require Government agencies in general, and the FSA in particular, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. Because of the date that the regulations for this program are required to be published, the forms and other information collection activities required by participation in the Peanut Quota Buyout Program (QBOP) are not yet fully implemented in a way that would allow the public to conduct business with FSA electronically. Accordingly, applications for this program may be submitted at the FSA county offices by mail or FAX.

Section 1309 of the 2002 Act repeals the marketing quota program for peanuts authorized by title III of the Agricultural Adjustment Act of 1938 (the 1938 Act). The regulations used to administer that program for the 1996 through 2002 crop years were codified at 7 CFR part 729. Other provisions of the 2002 Act set forth payment and marketing assistance loan programs for the 2002 through 2007 crops of peanuts that are similar to other major CCC commodity programs. Section 1309 also provides for CCC to pay eligible peanut quota holders as part of the transition from the repealed marketing quota program to the new programs.

Generally, this rule provides for payments to be made to each eligible peanut quota holder based on the amount of the peanut quota that was available to such holder for the 2001 crop year as provided by 7 CFR part 729 as it was codified on January 1, 2002. An eligible peanut quota holder is, generally, a person who, as of May 13, 2002, owned a farm that was otherwise eligible for a permanent peanut quota under section 358-1(b) of the 1938 Act. Temporary quota leases, transfers of peanut quotas for seed, and peanut quotas established for experimental purposes are not eligible peanut quotas for the buyout program established by this rule.

Eligible quota holders may elect to receive payment under this program in five equal installments in each of the 2002 through 2006 fiscal years, or as a single lump sum payment in any of these years. To the extent practical, CCC intends to make the 2003 through 2006 fiscal year payments between January 2 and January 31 of the applicable year. For those who choose the five-payment option, each QBOP payment will be determined by multiplying the $0.11 per pound rate provided in the law times the pounds of peanut quota for which such holder has been determined eligible for a payment. Persons who opt for the single lump payment will have their payment calculated in the same manner, except the payment rate will be $0.55 per pound.

FSA has highly accurate records of peanut quota holders and the amount of peanut quota assigned to each quota holder's farm because of the extensive record keeping and reporting requirements of 7 CFR part 729 used to monitor production of peanuts and related information necessary to establish each years' peanut quota. Additionally, in July of 2002, FSA sent each quota holder of record for the 2001 peanut crop the pounds of peanut quota assigned to each tract of land on every farm (as constituted for FSA purposes) in every county, and the total peanut quota assigned to that quota holder. This letter also notified the peanut quota holders that enrollment for this program would begin September 3, 2002, and end November 22, 2002. This notification was completed prior to the enrollment period for this program to ensure that each eligible peanut quota holder had sufficient time to validate the accuracy of the FSA records to be used to calculate the QBOP payment.

The 2002 Act provides that the date of enactment of that act is to be used to determine who is an eligible peanut quota holder, or who owned a farm that was eligible for a peanut quota under section 358-1(b) of the 1938 Act. The 2002 Act provisions also address the situation where peanut quota transfers were initiated prior to May 13, 2002, but not completed as of that date. For example, if there was a written contract for the purchase of all of a portion a farm that was eligible to have a peanut quota assigned to it in existence as of May 13, 2002, and the parties to the contract cannot agree on the manner in which such quota would be assigned to the different portions of the farm, payments are to be made in a fair and equitable manner taking into account any incomplete permanent transfer of such quota. Accordingly, CCC has determined that, in the case of the incomplete transfer of an entire farm, the eligible peanut quota holder will be considered the person contractually bound to purchase the entire farm. Where there was a partial sale of the farm not yet completed by such date, CCC will, if the parties cannot agree on the division of the peanut quota, assign the disputed quota taking into account the ratio of cropland on the unsold portion of the farm to the cropland on the portion of the farm subject to the purchase contract. Similarly, the 2002 Act provides that where there was in existence on May 13, 2002, an agreement for the permanent transfer of the peanut quota, but the transfer was not completed by that date, the holder will be the owner of the farm to which the peanut quota was to be transferred.

Consistent with the 2002 Act, if a written agreement was in effect before May 13,2002, for the purchase of all or portion of a farm and the parties had a written agreement specifying the distribution of the peanut quota, the buyout payment will be disbursed as specified in the agreement, so long as the resulting distribution is consistent with the 2002 Act. Also, if a farm is determined eligible for a permanent peanut quota on or before May 13, 2002, and the farm is sold in whole or in part after May 13, 2002, the peanut quota attributed to the owner of the farm as of such date cannot be transferred for purposes of determining a quota buyout payment. In addition, consistent with the manner in which CCC administers other commodity programs, a person who holds a life estate interest in a farm with a peanut quota will be considered the owner in determining who is an eligible peanut quota holder. A person with a remainder interest in such farm will not be considered to be an owner for such purposes.

The 2002 Act also provides that, notwithstanding any other provision of that Act, a person can be determined to be the eligible peanut quota holder if it is determined that such action is necessary for the fair and equitable administration of the program.

The 2002 Act provides that once a person's eligibility for the QBOP has been determined, such status is maintained whether or not there is a transfer of ownership of the farm. Accordingly, once it is determined that a person is eligible and CCC has executed a buyout contract with such person, the person may sell all or a portion of their farm and still receive the payment. CCC will not execute a quota buyout contract with a person who was the buyer of the farm in a transaction that took place after May 13, 2002. If such a person believes that the private sales transaction did not take into account these statutory and regulatory provisions, a private resolution of such a dispute must be undertaken by the parties to the contract; neither FSA nor CCC will participate in the resolution of such matter.

CCC has attempted to provide actual notice to all persons who are eligible to participate in this program, based upon the information required by FSA from peanut quota holders in the past. Still, there may have been transfers of farms that were not reported to FSA or incomplete transfers of peanut quotas and farms as of May 13, 2002. It is not possible for CCC to independently verify all of the many transactions that may have occurred with respect to farms and peanut quotas since the transfer of peanut quotas in 2001 until May 13, 2002. Accordingly, in order to ensure that only persons who meet the requirements of the 2002 Act receive a QBOP payment and to reduce debt collection efforts with respect to persons who improperly represented their eligibility status to CCC, CCC will require program participants to make certain representations regarding whether the peanut quota or their farm had been transferred to another person. Also, this rule provides that a claim of: (1) Ownership in a farm or peanut quota; or (2) transfer of a farm or peanut quota that should have been reported to FSA under 7 CFR part 729, but was not, may be disregarded in administration of QBOP in order to complete the transition as quickly as possible from the marketing quota program to the new programs.

Similarly, in contemplation that there will be disputes concerning who is the owner of a farm or peanut quota for purposes of determining the QBOP payment, this rule provides that if: (1) A payment is made to a peanut quota holder, as identified on FSA records, for a farm; and (2) a person who is not the peanut quota holder, as identified on FSA records, for a farm submits a quota buyout contract or other written claim to CCC more than 10 days after the date of publication of this rule, no further payments will be made with respect to such farm until CCC has determined the eligibility status of each claimant and any other person who may be eligible to receive the payment and the occurrence of the earlier of: (1) Repayment of the payment initially made to the peanut quota holder identified on FSA records; or (2) an administrative claim has been established for repayment of such payment under CCC's debt collection regulations at 7 CFR part 1403. If a contract or other written claim is provided to CCC within 10 days of the date of this rule by two or more persons for the same peanut quota used to calculate a buyout payment, no payment will be issued until CCC determines the eligibility status of each claimant. This procedure will allow payments to be made by CCC prior to the end of the program's enrollment period on November 22, 2002, while helping to ensure that erroneous payments are not made by CCC.

In summary, this rule contains two important time periods: (1) The program enrollment period of September 3, 2002 through November 22, 2002; and (2) the 10-day period beginning on October 1, 2002, and ending on October 11, 2002, which is the time in which persons not identified in FSA records as a peanut quota holder on a specific farm may submit a written claim to fully protect their interests under the QBOP.

Eligible peanut quota holders will receive about $1.3 billion in compensation for the lost value of their quota. Payments shall be issued under the contracts during fiscal years 2002 through 2006. In selection of the two options to receive payments, five equal installments, or the entire payment as a lump sum, eligible quota holders are expected to elect to receive about 90 percent of the payments, or $ 1.17 billion, in the first payment.

In an attempt to streamline the processing of petitions filed for agricultural workers, the Department of Justice in consultation with the DOL, decided that the Attorney General's authority to adjudicate certain H-2A petitions should be delegated to the DOL. It was estimated that the delegation of authority would shorten the processing time of H-2A petitions by as much as 10 days.

On July 13, 2000, the Attorney General published a final rule in the Federal Register at 65 FR 43528-43534 delegating the authority to adjudicate certain H-2A petitions for the temporary employment of nonimmigrant aliens in agriculture in the United States to the DOL. The final rule, which amended 8 CFR parts 103 and 214, was to take effect on November 13, 2000.

Also on July 13, 2000, the DOL published a final rule at 65 FR 43538 with an effective date of November 13, 2000, implementing the above-mentioned delegation of authority from the Service to the DOL.

On November 13, 2000, the Service published a final rule at 65 FR 67616, and DOL published an interim final rule at 65 FR 67628, each delaying the effective date of their respective July 13, 2000, H-2A rules until October 1, 2001.

On September 28, 2001, the Service at 66 FR 49514 published a subsequent final rule, and on September 27, 2001, DOL at 66 FR 49275 published another interim final rule with requests for comments, further delaying the effective date of the H-2A final rule until October 1, 2002. DOL also published a proposed rule at 66 FR 49329 on September 27, 2001 in conjunction with its interim rule of the same date announcing that it was holding two public briefings in order to obtain additional comments concerning the delegation of authority.

On July 13, 2000, and concurrently with the H-2A final delegation of authority rule, the Service at 65 FR 43535 published a companion notice of proposed rulemaking (NPRM) for public comment, proposing among other things that all petition requests, extensions of stay, and change of status petitions would be filed with DOL and that the current Service petition fee would be collected by DOL as part of the combined fee.

Concurrently with publication of the Service's proposed rule, the DOL published at 65 FR 43545 a companion NPRM setting forth implementation measures necessary for the successful implementation of the delegation of authority to adjudicate petitions.

On August 17, 2000, at 65 FR 50166, the Service reopened and extended the comment period for the proposed rule. Also on August 17, 2000, at 65 FR 50170, the DOL reopened and extended the comment period on its NPRM. This action was taken in order to obtain additional information from the public relating to the delegation such as the consolidation of forms and the appropriate fees as well as other issues.

The DOL held two public briefings to obtain additional information regarding the delegation of authority. The briefings were held at Washington, DC on November 8, 2001, and in Monterrey, California on November 16, 2001. After considering the comments received from the public at these two briefings, the DOL determined that the delegation of authority would not be a benefit to the public as initially contemplated. The attendees at these two briefings overwhelmingly disapproved of the transfer of authority between the two agencies, arguing that it would complicate the labor certification process rather than streamline it. Further, the attendees at the briefings expressed reservations about DOL's plans to consolidate the Service's Form I-129, Petition for Nonimmigrant Worker, with DOL's Form ETA-750A, Application for Alien Labor Certification.

In addition, subsequent to the initial proposal to delegate authority to DOL, the Service has changed its procedures and now requires that security checks be performed prior to the adjudication of any type of application and petition. The Service is more suited to perform these checks rather than the DOL.

Finally, the Administration has proposed that the nation's immigration function be reorganized within the newly established Department of Homeland Security. As a result, it does not appear that the delegation is appropriate at this time.

In consideration of these factors, the final rule published on July 13, 2000, at 65 FR 43528-45534 is being withdrawn in this final rule. In addition, in a document published elsewhere in this issue of the Federal Register , the Service is withdrawing the proposed rule that was published in the Federal Register on July 13, 2000, at 65 FR 43535.

The final rule published on July 13, 2000, can be withdrawn without further notice and comment because the delegation of authority to adjudicate petitions from the Attorney General to the Secretary of Labor constitutes a rule of agency practice or procedure within the meaning of section 5 U.S.C. 533(b)(A), and accordingly is exempt from the Administrative Procedure Act's notice and comment procedures. These procedural rules would not have made a substantive change in the rules, but instead would have transferred an existing procedural function from the one agency to another permitting employers to omit one step in the process of importing foreign agricultural workers. This rule nullifies that planned transfer, maintaining the status quo.

The Attorney General, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule is administrative in nature and merely withdraws a final rule published in the Federal Register .

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

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

This rule is considered by the Department of Justice, to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, this regulation has been submitted to the Office of Management and Budget for review.

This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

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

Under the Paperwork Reduction Act of 1995, Public Law 104-13, all Departments are required to submit to the Office of Management and Budget (OMB), for review and approval, any reporting requirements inherent in a final rule. This rule does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2000-07-10, amendment 39-11664 (65 FR 18881, April 10, 2000); which is applicable to certain Boeing Model 747-200B, -300, -400, -400D, and -400F series airplanes; was published in the Federal Register on April 3, 2002 (67 FR 15755). The action proposed to continue to require repetitive inspections to detect cracking of fire extinguisher discharge tubes in certain engine struts, and corrective action, if necessary. The action proposed to require a modification of the fire extinguisher discharge tubes, which would constitute terminating action for the repetitive inspections, and also proposed to add one additional airplane to the applicability.

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

Several commenters, including the Air Transport Association of America (on behalf of its members), request that the FAA revise the proposed AD to give credit for modifications accomplished in accordance with the original issue of Boeing Service Bulletin 747-26-2233, dated May 11, 1995. (Paragraph (b) of the proposed AD refers to Boeing Alert Service Bulletin 747-26A2233, Revision 1, dated November 16, 2000, as the appropriate source of service information for modification of the routing of the fire extinguishing tubes on Boeing Model 747-400 and 747-400F series airplanes equipped with Pratt & Whitney PW4000 engines.) The commenters note that there are no differences between the work instructions of the original issue and Revision 1 of that service bulletin.

The FAA concurs with the commenters' request. We note that paragraph (b) of AD 2000-07-10 refers to the original issue of Boeing Service Bulletin 747-26-2233 as the appropriate source of service information for accomplishment of the optional terminating action in that AD. This provision should have been included in the proposed AD. Accordingly, we have revised paragraph (b) of this AD to allow modification in accordance with either the original issue or Revision 1 of Boeing Service Bulletin 747-26-2233. Such modification will constitute terminating action for Boeing Model 747-400 and 747-400F series airplanes equipped with Pratt & Whitney PW4000 engines.

The FAA has changed all references to a “detailed visual inspection” in the proposed AD to “detailed inspection” in this final rule.

After careful review of the available data, including the comments noted above, we have determined that air safety and the public interest require the adoption of the rule with the changes previously described. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 268 airplanes of the affected design in the worldwide fleet. We estimate that 47 airplanes of U.S. registry would be affected by this proposed AD.

The inspections that are currently required by AD 2000-07-10, and retained in this AD, take approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required inspections on U.S. operators is estimated to be $2,820, or $60 per airplane, per inspection cycle.

The new modification required by this AD will take approximately 32 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts will cost approximately $5,488 per airplane. Based on these figures, the cost impact of this new requirement on U.S. operators is estimated to be $348,176, or $7,408 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 767-200 and -300 series airplanes powered by Pratt & Whitney (P&W) JT9D series engines was published in the Federal Register on November 19, 2001 (66 FR 57904). That action proposed to require replacement of the existing deactivation pin, aft cascade pin bushing, and pin insert on each thrust reverser half, with new, improved components.

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

One commenter supports the proposed AD, and notes that the design of the thrust reverser system on Model 767 series airplanes powered by P&W JT9D series engines is similar to that on Model 767 series airplanes equipped with P&W PW4000 series engines.

Two commenters disagree with the proposed AD, and one of these commenters requests that the FAA withdraw the proposal.

Both commenters note that the proposed AD is prompted by partial deployment of the thrust reversers on airplanes equipped with P&W PW4000 series airplanes, and no similar incidents have occurred on airplanes equipped with P&W JT9D series engines. The commenters emphasize that there are significant differences in design and function between the thrust reverser systems on these two engine models. Both commenters point out that, while the thrust reverser system on Model 767 P&W PW4000 series engines incorporates two hydraulic isolation valves—a motorized hydraulic isolation valve for deployment and a hydraulic stow valve for stowage, the thrust reverser system on Model 767 P&W JT9D series engines has only a hydraulic isolation valve, and no motorized isolation valve. The commenters maintain that the differences between the thrust reverser systems on the two engine models make the identified unsafe condition unique to P&W PW4000 series engines.

As further evidence of this, the commenters emphasize that the previous incidents occurred due to improper deactivation of the motorized isolation valve in the thrust reverser system by maintenance personnel who were not properly trained or did not follow procedures for proper deactivation of the thrust reverser system. Finally, both commenters point out that all previous incidents have occurred after landing during a commanded thrust reverser deployment, and they assert that this is not a safety-of-flight concern, but an economic concern ( i.e. , potential significant damage to the thrust reverser sleeves).

We do not concur with the request to withdraw the proposed AD. Although we recognize that there are differences between the two thrust reverser systems, we find that the similarities between the two thrust reverser systems make airplanes powered by JT9D series engines potentially subject to the identified unsafe condition. We note that the airplane manufacturer also considers these similarities sufficient to create the risk of an in-flight deployment of a thrust reverser.

Also, while we acknowledge that all previous incidents on Model 767 series airplanes powered by P&W PW4000 series engines occurred after landing, the airplane manufacturer has reported an incident of a partial in-flight deployment on a Model 747-400 series airplane powered by P&W PW4000 series engines. That incident has been attributed to improper deactivation of the thrust reverser. When deactivated, the thrust reverser is restrained by locking the hydraulic valve, locking and deactivating the sync lock, and inserting the deactivation pin. However, maintenance crews occasionally will improperly deactivate the hydraulic valve or sync lock, leaving only the structural integrity of the deactivation pin as protection from in-flight deployment. Considering the criticality of a deployment of a thrust reverser in mid-flight, we consider this a safety-of-flight issue.

Further, we acknowledge the commenters' remarks on training and supervision deficiencies. While increased training and proper supervision can alleviate the noted problems, current levels of training and supervision have not reduced the incidents of improper maintenance to an acceptable level.

For the reasons stated previously, we find that no change to the final rule is necessary in this regard.

The commenter that urges us to withdraw the proposed AD (as described in the previous section) states that the Work Instructions in Boeing Alert Service Bulletin 767-78A0089, dated July 19, 2001, cannot be accomplished on the thrust reverser system on Model 767 P&W JT9D series engines. The commenter points out that certain steps in the work instructions refer to components that do not exist on Model 767 P&W JT9D series engines. As noted previously, while the thrust reverser system on Model 767 P&W PW4000 series engines has two hydraulic isolation valves—a motorized hydraulic isolation valve for deployment and a hydraulic stow valve for stowage, the thrust reverser system on Model 767 P&W JT9D series engines has only a hydraulic isolation valve, no motorized isolation valve. Therefore, for example, the instruction in paragraph 3.B.4. of Boeing Alert Service Bulletin 767-78A0089 to “Deactivate the Motorized Isolation Valve and the Stow Valve * * *” cannot be done because there are not two valves to deactivate on the thrust reverser system on Model 767 P&W JT9D series engines.

These observations were part of the commenter's request for us to withdraw the proposed AD. We do not concur with this request. However, we acknowledge that the wording of the instructions in paragraphs 3.B.4. and 3.L.1. of Boeing Alert Service Bulletin 767-78A0089 is somewhat confusing.

Since we issued the notice of proposed rulemaking (NPRM), Boeing has issued Alert Service Bulletin 767-78A0089, Revision 1, dated May 30, 2002. Among other changes, Revision 1 of the service bulletin corrects the errors in the work instructions of the original issue of the service bulletin to which the commenter refers. Therefore, for clarification, we find it appropriate to revise paragraph (a) of this final rule to refer to Revision 1 of the service bulletin as the appropriate source of service information for the actions required by that paragraph. Also, we have added a new paragraph (b) to this final rule to state that replacements accomplished before the effective date of this AD according to the original issue of the service bulletin are acceptable for compliance with this AD.

One commenter requests that we revise the instructions of the referenced service bulletin to allow accomplishment of the replacement during maintenance, while the engine nacelle is off the wing, rather than with the engine nacelle mounted on the wing of the airplane. The commenter states that the service bulletin does not provide appropriate procedures for doing this. Specifically, the commenter requests that we revise the instructions in the service bulletin to provide for accomplishment of paragraphs 3.C. to 3.K. of the Work Instructions of the referenced service bulletin in the shop.

We agree that the service bulletin instructions need to be revised. As stated previously, since the issuance of the NPRM, Boeing has issued Revision 1 of the service bulletin. In addition to the changes explained previously, Revision 1 of the service bulletin adds a new Work Package III, which provides the instructions for modification of a spare thrust reverser that the commenter requests. We previously explained that we have revised paragraph (a) of this final rule to refer to Revision 1 of the service bulletin as the appropriate source of service information for the actions required by that paragraph, and we have added paragraph (b) to this final rule to give credit for replacements accomplished before the effective date of this AD according to the original issue of the service bulletin. Therefore, no further change to this final rule is necessary.

The same commenter requests that we reduce the number of post-replacement test cycles (extension and retraction of the thrust reverser to make sure it operates correctly), from three times, as specified in the service bulletin, to one time. The commenter states that, if the replacement is done with the engine nacelle in the shop rather than mounted on the wing, three test cycles are not necessary.

We do not concur. The commenter provides no data to justify its request, and we see no advantage to reducing the number of test cycles from three to one. However, if an operator considers that such a reduction in the number of test cycles will provide an acceptable level of safety, the operator may request approval of an alternative method of compliance with this testing requirement, as provided by paragraph (c) of this AD. No change to the final rule is necessary in this regard.

One commenter is concerned that the compliance time of 24 months allowed by the proposed AD may be too long. The commenter states, however, that it assumes that the FAA has carried out an appropriate risk assessment to justify the proposed compliance time.

We infer that the commenter is requesting that we reduce the proposed compliance time for the actions required by this AD. We do not concur. The commenter provides no data to justify its statement that the proposed compliance time may be too long. As stated in the proposed AD, in developing an appropriate compliance time for this AD, we considered not only the manufacturer's recommendation, but the degree of urgency associated with addressing the subject unsafe condition, the average utilization of the affected fleet, and the time necessary to perform the replacement. In light of these factors, we find that 24 months is an appropriate interval to allow affected airplanes to continue to operate without compromising safety. No change to the final rule is necessary in this regard.

One commenter requests that we extend the compliance time for the proposed requirements from 24 months to 30 months. The commenter states that it would like to do the proposed replacement during a scheduled maintenance visit, but sufficient parts may not be available to allow for this.

We do not concur with the request to extend the compliance time for the actions required by this AD. Based on the latest information provided to us by the airplane manufacturer, an ample supply of required parts will be available within the 24-month compliance period. As stated previously, we find that 24 months is an appropriate interval for affected airplanes to continue to operate without compromising safety. No change to the final rule is necessary in this regard.

For clarification, we have made minor revisions to the wording of Note 2 of this final rule.

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

There are approximately 90 Model 767-200 and -300 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 26 airplanes of U.S. registry will be affected by this AD, that it will take approximately 12 work hours (6 work hours per engine) per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will cost approximately $12,108 per airplane. Based on these figures, the cost impact of this AD on U.S. operators is estimated to be $333,528, or $12,828 per airplane.

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

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

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

The FAA received reports of three occurrences of cracks found on the left hand upper longeron and upper diagonal support tubes where they intersect on the left hand side of the fuselage frame just forward of the vertical fin front spar attachment point on Air Tractor Model AT-602 airplanes. The crack starts at the forward edge of the weld where the tubes come together. We initially determined that the cracks resulted from high vertical tail loads during repeated hard turns. The cracks were found by the pilot and/or ground crew when they noticed excessive movement in the empennage due to the loss of torsional rigidity.

Air Tractor started installing extended reinforcement gussets on AT-402 and AT-802 series airplanes at the factory to alleviate the crack condition from occurring. The extended reinforcement gussets were intended to transfer the loads away from the joint. However, further cracking has been reported on 3 more AT-602 airplanes, as well as 1 AT-402 series, and 3 AT-802 series airplanes. One of the AT-802 airplanes had the extended reinforcement gusset installed during factory production. Air Tractor discovered that the factory installed extended reinforcement gusset, which runs further forward than the original gusset, is also cracking at the forward end of the extended gusset.

This condition, if not corrected, could cause the fuselage to fail. Such failure could result in loss of control of the airplane.

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 certain Air Tractor Model AT-402, AT-402A, AT-402B, AT-602, AT-802, and AT-802A airplanes. This proposal was published in the Federal Register as a supplemental notice of proposed rulemaking (NPRM) on June 28, 2002 (67 FR 43568). The supplemental NPRM proposed to require you to repetitively inspect the upper longeron and upper diagonal tube on the left hand side of the aft fuselage structure for cracks and contact the manufacturer for a repair scheme if cracks are found.

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:

The FAA has determined that long-term continued operational safety would be better assured by design changes that remove the source of the problem rather than by repetitive inspections or other special procedures. With this in mind, FAA will continue to work with Air Tractor in performing further tests to determine the cause of the cracking and to provide a corrective action, terminating the need for repetitive inspections.

The Air Tractor AT-500 series airplanes have a similar design in the upper longeron in the aft fuselage structure. However, we have not received any reports of damage in this area on those airplanes. The only reports of damage are those previously referenced on the AT-402 series airplanes, Model AT-602 airplanes, and AT-802 series airplanes.

Air Tractor is currently researching this subject on the AT-500 series airplanes. Based on this research and if justified, we may propose additional rulemaking on this subject for these other airplanes.

We estimate that this AD affects 248 airplanes in the U.S. registry.

We estimate the following costs to accomplish the inspection(s):

We have no method of determining the number of repairs or replacements each owner/operator would incur over the life of each of the affected airplanes based on the results of the proposed inspections. We have no way of determining the number of airplanes that may need such repair. The extent of damage may vary on each airplane.

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 copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

In the event of a discharge or substantial threat of a discharge of oil (incident), the Oil Pollution Act of 1990 (OPA), 33 U.S.C. 2701 et seq. , provides that Federal, State, Indian tribal, and/or foreign natural resource trustees (trustees) assess natural resource damages and develop and implement a plan for the restoration, rehabilitation, replacement, or acquisition of the equivalent of the injured natural resources and their services. Congress directed the National Oceanic and Atmospheric Administration (NOAA) to promulgate regulations for the assessment of natural resource damages resulting from an incident (OPA section 1006(e)(1)). NOAA promulgated final regulations on January 5, 1996 ( see 61 FR 440), codified at 15 CFR part 990.

Under these OPA regulations, trustees conduct natural resource damage assessments in the open, with responsible parties and the public involved in the planning process to achieve restoration more quickly, decrease transaction costs, and avoid litigation. These restoration plans form the basis of claims for natural resource damages. Under the natural resource damage assessment regulation, trustees then present a demand comprised of the final restoration plan to responsible parties for funding or implementation, plus assessment costs. These final regulations were challenged pursuant to section 1017(a) of OPA. On November 18, 1997, the United States Court of Appeals for the District of Columbia Circuit issued a ruling on the final regulations ( General Electric Co., et al. , v. Commerce , 128 F.3d 767 (D.C. Cir 1997)). The Court remanded to NOAA for further agency decisionmaking: (1) authorization for the removal of residual oil, and (2) the scope of authorization for recovery of legal costs. NOAA also proposed clarifying and technical amendments in other parts of the regulations.

In General Electric Co., et al. , v. Commerce , the Court asked NOAA to explain the change in language regarding the removal of residual oil between the Final Regulation and its preamble for natural resource damage assessments and the previous Proposed Rule. The Court also raised a series of questions on the relationship and coordination between response and restoration authorities.

The Court ruled that the Proposed Rule did not authorize trustees to actually “remove” oil and that the provision in the Final Regulation, which did authorize such “removal,” could not be upheld because NOAA failed to explain this change in language.

NOAA did not intend any substantive change by the edits in language between the proposed and final regulations. NOAA did not intend to propose shared “removal authority,” as defined by OPA. Removal authority is exclusively provided to the U.S. Environmental Protection Agency (EPA) and the U.S. Coast Guard (Coast Guard) under the Clean Water Act, 33 U.S.C. 1321 (CWA), Executive Order 12777 (56 FR 54757, Oct. 22, 1991), and the National Oil and Hazardous Substances Pollution Contingency Plan, 40 CFR part 300 (1994) (NCP). Removal of oil will be conducted under the authority of the On-Scene Coordinator (OSC). The OSC's authority will be carried out in accordance with the NCP.

However, NOAA has always intended that the regulations authorize trustees to eliminate or reduce exposure of natural resources to oil resulting from an incident, but only if such action is selected in accordance with standards and procedures for restoration set forth in the Final Regulation. NOAA acknowledges that the Proposed Rule may not have expressed this intent clearly. As a result, NOAA maintains that trustees must have the authority to eliminate or reduce the impediments to restoration, including residual oil, to bring about effective restoration, rather than be limited to merely considering such impediments, as erroneously suggested by the Proposed Rule ( see, e.g., 61 FR 452).

The Court expressed concern that giving trustees the authority to remove residual oil would be inconsistent with OPA because it would allow trustees to second guess and encroach upon response agencies that have exclusive removal authority. NOAA did not intend to grant shared removal authority between response and trustee agencies. Further, recognition of the trustees' authority to address residual oil through selection of a restoration action would not be granting trustees the authority to second guess response agencies because selection of restoration actions is based upon different information and criteria than are used by the response agencies in making removal decisions.

“Removal” is a term of art under the applicable statutes and regulations. “Removal” is defined as:

While “removal” involves taking whatever actions are needed to prevent or reduce damage caused by a threat of or actual spill, natural resource damage assessment and restoration involve an investigation and planning process that is aimed at returning the environment to baseline conditions, i.e., the state it would have been in had the incident not occurred, by implementing restoration approaches as provided under OPA. Although not defined under OPA, restoration is defined in the Final Regulation to encompass “any action that returns injured natural resources and services to baseline” and “any action taken to compensate for interim losses of natural resources and services that occur from the date of the incident until recovery.” 15 CFR 990.30. Restoration actions may only be taken in accordance with the provisions in the Final Regulation governing their identification, evaluation, selection, and documentation. For example, trustees evaluate restoration alternatives using factors provided in the Final Regulation including the: Cost to carry out the alternative; extent to which each alternative is expected to meet the trustees' goals and objectives in returning the injured natural resources and services to baseline and/or compensating for interim losses; likelihood of success of each alternative; extent to which each alternative will prevent future injury as a result of the incident, and avoid collateral injury as a result of implementing the alternative; extent to which each alternative benefits more than one natural resource and/or service; and effect of each alternative on public health and safety (15 CFR 990.54(a)). Nothing in the statute or its legislative history suggests that trustees are prohibited from undertaking restoration actions that involve eliminating or reducing exposure of natural resources to oil.

Another area causing potential confusion with removal actions is the Final Regulation provisions on emergency restoration in § 990.26. Section 990.26 of the Final Regulation currently states that trustees may conduct emergency restoration when: “(1) The action is needed to minimize continuing or prevent additional injury; (2) The action is feasible and likely to minimize continuing or prevent additional injury; and (3) The costs of the action are not unreasonable.” Since that language may tend to confuse restoration and removal, NOAA proposed amendments to § 990.26 to clarify that the purpose is not to undertake any additional “removal” action, but that the intent of the emergency restoration provisions is to comport with the statutory language of section 1012(j) of OPA, which exempts emergency restoration from public notice and comment when it is needed “to avoid irreversible loss of natural resources, or to prevent or reduce any continuing danger to natural resources or similar need for emergency action,” and to mitigate the ultimate natural resource damages resulting from the incident that would result from delaying the emergency restoration action. This provision was consistent both with the language and purposes of OPA and with the tort law concept that persons who are seeking damages for an injury may take reasonable steps to mitigate damages, even before the claim has been asserted or adjudicated, by repairing some or all of the injury. Therefore, NOAA proposed to amend § 990.26(a) to read:

(a) Trustees may undertake emergency restoration before completing the process established in this part provided that:

(1) The action is needed to avoid irreversible loss of natural resources, or to prevent or reduce any continuing danger to natural resources or similar need for emergency action;

(2) The action will not be undertaken by the lead response agency;

(3) The action is feasible and likely to succeed;

(4) Delay of the action to complete the restoration planning process established in this part likely would result in increased natural resource damages; and

(5) The costs of the action are not unreasonable.

NOAA also proposed to amend § 990.26(b) to provide that, if response actions are still underway, trustees must coordinate with the OSC before implementing any emergency restoration action. The amendments provided that trustees may take such action only if that action will not interfere with or duplicate the ongoing response action. Finally, the amendments also provided that emergency restoration addressing residual oil can proceed only if the response action is complete or if the OSC has determined that the residual oil identified by the trustee as part of a proposed emergency restoration action does not merit further response. This coordination shall take place through the procedures specified in the NCP.

Given the fact that the parenthetical language of § 990.53(b)(3) of the Final Regulation caused confusion on this issue, NOAA proposed that subsection be amended to delete the parenthetical language, “ e.g., residual sources of contamination.” For the same reason, NOAA replaced the term “remove” with the term “address” in § 990.53(b)(3).

In its opinion in General Electric Co., et al. , v. Commerce , the Court posed a number of specific questions for NOAA to address. The preamble to the proposed amendments published on July 31, 2001, at 66 FR 39466-39467, answered these questions upon consultation with the Coast Guard and EPA. Although the questions were addressed in the preamble, NOAA believes that the language bears repeating. Therefore, the questions from the Court and their answers are given here to clarify the relationship between response and restoration.

As previously stated, NOAA did not intend to confer upon trustees shared “residual removal authority” by this rulemaking. Rather, NOAA and the lead federal response agencies maintain that trustees may implement an action to eliminate or reduce exposure to oil in the environment if that action comprises an appropriate part of a restoration plan developed in accordance with the Final Regulation. Thus, it is inappropriate to characterize the trustees' action as an exercise of “residual removal authority.”

OPA section 1006(c) directs trustees to assess natural resource damages, and to develop and implement a plan for restoration, rehabilitation, replacement, or acquisition of the equivalent of the natural resources under their trusteeship, after providing for public review and comment on such plans (33 U.S.C. 2706(c)(1)). OPA does not define “restoration,” but the Final Regulation describes this authority as encompassing “any action ... that returns injured natural resources and services to baseline” and “any action taken to compensate for interim losses of natural resources and services that occur from the date of the incident until recovery.” 15 CFR 990.30, 61 FR 505.

In contrast, removal as defined under the CWA, OPA, and the NCP addresses actions taken by the lead response agency necessary to “prevent, minimize or mitigate” damage to the public health or welfare, including the environment. The Final Regulation acknowledges that removal actions may reduce or eliminate the need for subsequent natural resource damage assessment and restoration activities ( see, e.g. , 61 FR 443, col. 2: “Coordination among trustees and response agencies can result in reducing or eliminating natural resource or service injuries residual to the cleanup;” 61 FR 444, col. 3: “This rule provides procedures by which trustees may determine appropriate restoration of injured natural resources and services, where such injuries are not fully addressed by response actions;” 61 FR 461, col. 2: “NOAA agrees that restoration actions by trustees are intended to supplement the initial response and cleanup activities of response agencies.”). The Final Regulation also acknowledges that response actions may be limited in scope and may not alleviate restoration concerns (61 FR 449, col. 1).

Thus, NOAA and the federal response agencies interpret OPA as granting complementary authority to response agencies and trustees. Response and restoration authorities are respectively distinguished primarily by the need for action to prevent, minimize or mitigate harm versus action to restore injured natural resources and services to baseline conditions.

The trustees have no authority to undertake a “removal” action per se, but may select a restoration alternative that involves reducing or eliminating exposure to residual oil. The Final Regulation authorizes trustees to eliminate or reduce exposure to residual oil when such action has been selected in accordance with the restoration planning process in the OPA regulation. That is, the trustees could eliminate or reduce exposure to residual oil when they have developed a reasonable range of restoration alternatives that might include removal of residual oil, among other options, evaluate those restoration alternatives using the selection criteria in the OPA regulation, and select an alternative that includes removal of residual oil as the most appropriate restoration alternative for the injuries resulting from the incident. In cases where trustees do consider a restoration alternative involving the reduction or elimination of exposure to residual oil, the reasonable range of alternatives should include not only a natural recovery alternative, but also an alternative in which the residual oil is left but human intervention occurs, such as off-site acquisition or enhancement of substitute habitat, to address the injured resources.

The lead response agency's removal authority under the CWA may include actual removal or containment of oil, or other actions “necessary to prevent, minimize or mitigate damage to the public health or welfare, including, but not limited to, fish, shellfish, wildlife, and public and private property, shorelines and beaches.” 33 U.S.C. 1321(a)(8),(c),(e). As discussed above, the lead response agency's goals include preventing or reducing harm to the public health or welfare, including the environment that would result from exposure to oil. The objective of the lead response agency is to remove as much oil as is needed to prevent, minimize or mitigate harm. In contrast, the trustee's authority to eliminate or reduce exposure to residual oil is derived exclusively from restoration authority under OPA. As such, the trustee's authority is limited to those instances where residual oil would prevent or limit the effectiveness of restoration, as stated in § 990.53(b)(3) of the Final Regulation.

The trustee's role in a removal action is defined in section 1011 of OPA, which provides that: “The President shall consult with the affected trustees designated under section 2706 of this title on the appropriate removal action to be taken in connection with any discharge of oil.” 33 U.S.C. 2711. During this consultation, the trustee may advise the lead response agency on removal actions that could be taken to prevent, reduce, or eliminate impacts to natural resources. Removal decisions made by the lead response agency are intended to minimize or mitigate harm to the environment. Although these decisions may affect the nature and extent of trustee restoration actions, the decisions are not based upon the trustee goals of restoring the environment to baseline conditions and compensating for the loss of natural resources.

Generally, response agencies do not have a role in restoration actions by trustees. However, the Final Regulation does allow “emergency restoration,” under § 990.26. Under § 990.26 (a), emergency restoration is allowed where: “(1) The action is needed to minimize continuing or prevent additional injury; (2) The action is feasible and likely to minimize continuing or prevent additional injury; and (3) The costs of the action are not unreasonable.” NOAA is amending the provisions of § 990.26(a) to clarify that the purpose of trustees conducting emergency restoration is to reduce the ultimate damages resulting from the incident. If emergency restoration is considered while response actions are still underway, § 990.26(b) requires that the trustee coordinate with the lead response agency's OSC before taking any emergency restoration action and demonstrate that the emergency restoration action will not duplicate or interfere with any on-going response actions.

NOAA believes that the lead response agency's rejection of a trustee's request for removing oil under the consultation provisions of section 1011 of OPA should neither bar nor precipitate such actions as part of a restoration plan developed in accordance with the Final Regulation. The response agency's refusal of a trustee's request in no way constitutes a conclusion regarding whether such an undertaking is appropriate as natural resource restoration. The response agency may make a determination, based upon available information, that removal is not necessary to prevent further impact to human health, welfare, or the environment. Subsequently the trustees, based upon information and analysis developed during the damage assessment process, may select a restoration alternative that involves elimination or reduction of residual oil. These determinations are not in conflict, and both are proper.

The trustee's concurrence with the response agency's decision to leave oil in the environment during the response phase does not preclude the trustee's consideration of removal of residual oil if such action is deemed appropriate based upon information gained during the damage assessment process to reinstate baseline conditions or compensate for lost services.

The Court indicated that such agreement is most likely needed by a reviewing court.

The Federal response agencies agree that actions to eliminate or reduce exposure to oil need not occur solely under their response authorities, and can legitimately be conducted as a restoration action under OPA, consistent with the Final Regulation. The Federal response agencies also agree that coordination of removal activities in all cases will occur as specified within the NCP.

1. On February 11, 1998, NOAA published a request for public comments concerning the authorization for the removal of residual oil by trustees as part of a natural resource restoration action. 63 FR 6846. Specifically, NOAA invited commenters to submit information on both case-specific and other consultation experiences with the Coast Guard, EPA, or State response agencies relating to removal actions taken either during or following the response phase of an incident. NOAA also requested reports of any standards, circumstances, and outcomes of incidents where trustees considered additional removal actions beyond those proposed by the lead response agency. Twelve separate parties responded to the request for comments. Comments were received from five industry representatives, four from state trustee representatives, one from EPA, and two from individual members of the public. Comments received are summarized and addressed below.

Comment: One commenter, a private cleanup contractor, described a “unique design” of skimmer used by his company as an environmentally friendly approach to removal of residual oil.

The second individual commenter advocated that trustees not be allowed to ask for more cleanup than that performed by the response agency, in order to avoid needless work and the potential to cause more environmental harm than that avoided by the additional work.

Response: NOAA takes note of the cleanup approach suggested by the first commenter. NOAA does not agree with the second commenter that addressing residual oil is needless work. NOAA also points out that one of the considerations trustees must address in selecting a restoration project is whether that project will inflict additional harm upon the environment.

Comment: One trustee representative relayed experiences from a unique situation involving residual oil, in which oily sand was piled up into “tar dunes” in front of vegetated zones of beaches by response personnel. The decision was characterized as a joint decision among response and trustee personnel, based in part on the desire to minimize removal of sand from the beaches, and on uncertainty whether the dunes would cause any additional injury to natural resources. The trustee stated that in hindsight the agency would always recommend that oily sand be removed from beaches and replaced with clean sand from an appropriate source. In addition, this trustee was of the opinion that the agency would have the authority to request responsible parties to conduct this type of residual removal as part of a restoration plan. A second trustee representative commented on a specific case example involving residual oil in which trustees were heavily involved in the response planning and decisionmaking. The decision to leave residual oil in the environment in this instance was made with the agreement of the trustees, because additional removal would have killed individuals of an endangered species. Another trustee commenter reported on an experience in which removal of residual oil long after an incident was paid for out of restoration funds paid by a responsible party and held by trustees in a trust account.

Response: NOAA takes note of these comments.

Comment: Another trustee representative stated its agreement with NOAA's proposed amendments that trustees have legal authority to remove residual oil as part of a restoration plan. The commenter suggested that Congress obviously intended a degree of overlap between removal and restoration. The commenter stated that removal of residual oil is often necessary and even unavoidable as a restoration action, citing an example where oil unaccounted for by response efforts was discovered later in sediments of a protected natural area. Finally, this commenter urged NOAA to respond in the amended Final Regulation to all of the D.C. Circuit's questions posed in remanding this issue.

Response: NOAA agrees with the commenter that addressing residual oil is sometimes necessary and unavoidable as a restoration action. NOAA also points to the responses to the Court's questions above in section I.B. of this preamble.

Comment: EPA commented that it agrees that trustees have authority to remove residual oil as part of implementation of a publicly-reviewed restoration plan. EPA also noted, however, that Federal response agencies and trustees must consult and coordinate during an incident to ensure protection and restoration of potentially injured natural resources due to an oil spill. EPA suggested that incidents supporting the need for removal of residual oil should be few if the coordination and consultation process works.

Response: NOAA takes note of this comment and agrees with EPA on this issue.

Comment: One group of industry representatives stated that trustees should not be authorized to undertake response actions, including removal of residual oil beyond that directed by the lead response agency in consultation with trustees. The commenters stated that NOAA should answer all of the D.C. Circuit's questions concerning the interrelationship of response and restoration authority. These commenters suggested drawing strong and clear distinctions between response and trustee authorities, roles, and responsibilities. Citing to numerous sections of the NCP and EPA's July 31, 1997, OSWER Directive No. 9200.4-22A, the commenters characterized the proper role of resource restoration as supplemental to, and consistent with, response actions and criteria selected by the lead response agency.

Response: NOAA notes that trustees acting pursuant to the Final Regulation will not attempt to usurp the role of the lead response agency. NOAA also refers the commenter to the response to the Court's questions given above in section I.B. of this preamble.

Comment: A second group of industry commenters also concluded that EPA and the Coast Guard have exclusive authority to determine when removal is complete, and that trustees' interests are protected by, and limited to, consultation with the lead response agency pursuant to section 1011 of OPA. These commenters suggested that the OPA, CWA, and NCP all draw clear lines between removal and restoration, citing as support the different liability provisions and different statutes of limitations for removal costs and for natural resource damages in OPA. These commenters also suggested that the remanded regulation provision on the removal of residual oil, which could be used solely by state or tribal trustees, undermines Congress' intent that removal under OPA always be conducted under the supervision of federal authorities. These commenters urged NOAA to remove § 990.53(b)(3)(i) from the regulation.

Response: NOAA agrees with the commenter that the response agencies have exclusive authority to determine when removal is complete. However, NOAA does not agree that the trustees' interests are limited to consultation with the lead response agency. NOAA notes that, in consultation with the Coast Guard and EPA, it has responded to the Court's questions above in Section I.B. of this preamble. NOAA points out that § 990.53(b)(3)(i) does not and should not address which trustees may use these provisions nor does it undermine Congressional intent.

Comment: A third group of commenters representing industry concerns noted that oil spill cleanup is critically important, in part, because it may also achieve restoration and eliminate the need for further compensation to the public. These commenters stressed that “too many cooks” can hamper the effectiveness of response actions in achieving this and other goals, and suggested that this was one reason why Congress limited trustees' role during response to a consultative one. However, these commenters stated that they would support removal of residual oil by trustees in instances where it is necessary to assist natural recovery of injured resources, so long as such action is the most cost-effective restoration action, and that the claim for the costs of such action is developed in accordance with established damage assessment and restoration planning procedures.

Response: NOAA notes and appreciates the offer of support from these commenters. In response to the comment on cost-effectiveness, for emergency restoration actions, § 990.26(a)(5) specifically requires that the costs of the action not be unreasonable. For non-emergency restoration conducted pursuant to a publicly-reviewed restoration plan, § 990.54(a) provides standards for evaluating a range of restoration alternatives and § 990.54(b) includes a cost-effectiveness requirement.

Comment: A fourth commenter representing an industry association also stated that the Final Regulation should reflect the clear legal distinction drawn by Congress in OPA between removal of oil and restoration of natural resources. This commenter stated that NOAA should not attempt to authorize any removal authority for trustees. However, this commenter also recognized that removal of oil can comprise an effective restoration action, and that in reality there is no existence of a time certain at which removal stops and restoration begins. Citing the purpose of OPA's requirement that response agencies consult with trustees, this commenter advocated that natural resource damage assessment activities proceed apace with response in such a fashion that the removal completion decision can take into account the need to remove more oil in order to achieve effective restoration.

Response: Again, NOAA notes that it is not attempting to create removal authority for trustees. NOAA does agree that trustees should work where possible through the consultation process with the lead response agency to address removal of oil that might impede restoration. However, NOAA points out that § 990.53(b)(3)(i) is necessary to allow restoration to succeed where residual oil not subject to the removal process will impede restoration.

Comment: The fifth group of industry commenters also stated that they would support trustee authority to remove residual oil if it is the most cost-effective restoration alternative, in certain circumstances. Specifically, these commenters urged NOAA to revise the regulation such that an injury to a natural resource for which trustees could seek restoration, including by removal of residual oil, be defined as a loss of a service that the resource provided to the public. Appropriate restoration would be limited to reinstatement of these services and could include elimination of oil from the environment if this action achieved reinstatement of services. The commenters argued that OPA's grant of authority to response agencies to abate threats to the environment overlaps with authorities NOAA granted to trustees under the amendments to restore lost ecological functions or services. These commenters urged that NOAA revise the Final Regulation to eliminate the potential for any overlap between response and restoration authorities and actions. These commenters also urged that trustees work closely with removal agencies to identify in a timely manner whether additional removal is likely to be proposed as a restoration alternative, so that all removal can be carried out simultaneously.

Response: NOAA notes and appreciates the support of these commenters. In response to the comment on cost-effectiveness, as noted earlier, for emergency restoration actions, § 990.26(a)(5) specifically requires that the costs of the action not be unreasonable. For non-emergency restoration conducted pursuant to a publicly-reviewed restoration plan, § 990.54(a) provides standards for evaluating a range of restoration alternatives and § 990.54(b) includes a cost-effectiveness requirement. NOAA does not believe that the physical removal of residual oil by trustees constitutes a type of restoration that must be evaluated any differently from the other types of restoration actions, except for the safeguards that the Final Regulation puts in place for emergency restoration actions that address residual oil. Nor did the commenters provide a basis for treating this type of restoration action differently from all others and subjecting it to a special and determinative cost-effectiveness criteria. However, NOAA would not attempt to limit or restrict trustee actions by only addressing threats to restoration success in situations involving “loss of services” to the public, since the Final Regulation currently provides the flexibility to the trustees in making restoration decisions. NOAA agrees that trustees should coordinate closely with the lead response agency to try to address the removal of all oil deemed necessary.

2. On July 31, 2001, NOAA published proposed amendments to the Final Regulation to address the remanded issues, including the issue of residual oil. 66 FR 39464. Only four comments were received on the proposed amendments regarding the issue of addressing residual oil: three comments from industry representatives and one comment from a coalition of State officials. The comments from industry representatives are similar and are therefore summarized and addressed as one set of comments.

Comment: One major area of concern from industry representatives is that trustees do not have the authority to “remove” residual oil. The commenters maintain that the removal authority under OPA and the NCP, in particular, is clear and sufficiently broad to address any impediments to restoration resulting from residual oil. In support of preserving the statutory status quo, the commenters cite to Congressional and statutory language that unambiguously distinguish removal and restorations authority in terms of goals, scope, and provisions regarding liability and claims. (See, definition of “removal” authority at OPA section 1001(30), CWA sections 311(c) & (d), and NCP § 300.5.; on Congressional intent at H. Conf. Rep. No. 653, 101st Cong., 2d Sess. (1990), at 146; on liability provision at OPA sections 1002(b)(1) & (b)(2)(A); on claims at OPA sections 1017(f)(1)(b) & (f)(2) and the Oil Spill Liability Trust Fund claims procedures.) The commenters further cite the distinct roles and responsibilities between the response agencies and trustees as evidence of statutory intent to maintain removal of residual oil under the direction of the OSC, not the trustees. (See the President's responsibility at CWA section 311(c)(1), as amended by OPA section 4201; President's has delegated responsibilities to EPA at Executive Order 12777, 56 FR 54757 (Oct. 22,1991); and duties of lead response agencies at 40 CFR Part 300.) One commenter suggested that cleanup resources may be unavailable to the OSC if trustees are using these resources for removal of “residual oil.”

The commenters state that NOAA's proposed amendments to the Final Regulation are an attempt to provide removal authority to trustees under the guise of restoration. The commenters claim that NOAA does not have the authority to grant itself such authority, that the granting of residual oil removal authority to trustees would be inconsistent with the statutory language under OPA and the NCP. The commenters further argue that NOAA has not adequately explained the standards and protections for its “new-found” removal authority, and how this claimed authority would relate to the authority granted to the OSC under the statute. The commenters also noted that there is no requirement that the additional removal of oil by trustees be cost-effective or demonstrate a net environmental benefit.

A second substantive issue of the commenters is that, if trustees are granted residual oil removal authority, the regulations will disrupt the decisionmaking process and operational scheme defined under the NCP to remove residual oil (NCP Subparts B-D). Under NOAA's proposed amendments, the commenters indicate that trustees might be able to take removal actions contrary to OSC decisions and prior trustee positions respecting removal actions while the OSC would have no say in trustee residual oil removal actions. The commenters note that the principal difference in NOAA's proposed amendments is the identity of the decisionmaker, not the decision. The commenters indicate that the current procedural safeguards under the NCP work. Changing the NCP would compromise removal decisions and serve as a disincentive to industry to cooperate and coordinate with response agencies. The commenters also stated that there should be no time line imposed upon the OSC's decision regarding oil removal. The commenters cited the Tampa Bay case as one example of the trustees second-guessing the OSC. One commenter stated that allowing trustees to conduct additional oil removal may increase the liability of the responsible party. If this additional oil removal is not part of the established response process, then these costs may not be reimbursable to the responsible party if the liability limit is exceeded.

The commenters argue that the U.S. Court of Appeals for the District of Columbia Circuit should dismiss NOAA's arguments that trustees have the right to conduct removal of residual oil under the “guise of restoration.” The commenters argument is based upon their belief that NOAA did not adequately respond to the Court's questions, that NOAA failed to address the commenters' concerns in a prior Federal Register notice, and that NOAA is unclear regarding the position of the Federal lead response agencies (the Coast Guard and EPA) regarding NOAA's proposed amendments. The commenters recommend that the proposed amendments to NOAA's Final Regulation be revised in such a way that would not allow trustees to have the authority to address residual oil during emergency restoration or other resource restoration activities.

Response: The proposed amendments did not grant authority to trustees to conduct removal under the “guise of restoration.” NOAA has clearly stated in the proposed amendments that it does not intend, nor was it intended in the Final Regulation, to grant “removal authority” to trustees as provided to the response agencies under OPA and the NCP (66 FR 39465 and 39471, thus, for instance, the change in terminology from “removal” to “address” § 990.53(b)(3)(i)). However, NOAA firmly believes that Congress did not intend to limit the ability for trustees to conduct restoration in an efficient or effective manner. As a result, the regulations authorize trustees to address residual oil if such action clears the way to cost-effective restoration. As mentioned earlier, § 990.54(b) includes a cost-effectiveness requirement.

Limiting the ability of trustees to initiate restoration as suggested by the commenters, could result either in more and costlier restoration, or in the inability of trustees to exercise any options to address residual oil that may serve as an impediment to restoration. NOAA believes that such alternative actions do not serve any member of the public and that trustees should have authority to evaluate a broad range of restoration alternatives.

The proposed amendments maintained the opportunity for trustees “to eliminate or reduce exposure to oil resulting from an incident” (66 FR at 39464, col. 3), if such action represents a preferred restoration alternative under the provisions of the regulations. Trustees have the authority to take limited “emergency” restoration actions consistent with that granted under OPA section 1012(j) and tort law. (66 FR at 39465, col 2.) While the commenters may perceive such restoration actions as “removal” actions that may be taken arbitrarily or in conflict with OSC decisions, they are not, nor would the trustee actions monopolize response resources. NOAA stated in its proposed amendments that restoration actions, including emergency actions as defined by OPA section 1012(j), must be consistent with the standards and procedures set forth under OPA (OPA section 1006), the Final Regulation ( e.g. , 15 CFR 990.54(a)), and the proposed amendments to the Final Regulation. Emergency restoration actions must also abide by the consultative requirements of the NCP and the determination of the OSC to reconsider or re-open a removal action or otherwise defer such action for restoration under trustee rules. (NCP Subpart D.) The trustee authorities described in the regulations are limited to restoration decisions made using restoration criteria, not the distinctly different decision framework used by the OSC to prevent, minimize or mitigate damage to human health, welfare, and the environment. Contrary to the arguments of the commenters, the decision truly is different, not just a function of the decision maker.

As to the argument that the costs of addressing residual oil will not be recoverable if the responsible party exceeds liability limits, NOAA points out that such costs would be recoverable to the responsible party as restoration costs.

The commenters cite the Tampa Bay example as a case where the trustees are alleged to have second-guessed the OSC. The commenters assertions misrepresent the facts of this case. In the Tampa Bay case, emergency restoration actions were taken only after extensive consultation with the OSC and the potentially responsible parties. Emergency restoration actions were determined necessary by the trustees upon the discovery of conditions that would have potentially resulted in the need for more and costlier restoration if no action were taken. This discovery was made possible through monitoring after the completion of removal actions. Given the circumstances at hand, the OSC determined it was best to defer further action to the trustees. ( See, in particular, Sections 4.7 and Appendix D of the Tampa Bay Damage Assessment and Restoration Plan/Environmental Assessment for the August 10, 1993, Tampa Bay oil spill, Volume 1—Ecological Injuries, Final, June 1997 in the Tampa Bay Administrative Record; and the paper on Tampa Bay in the NRDA Lessons Learned Workshop, May 11-12, 2000, New Orleans, LA. Both documents are available at http://www.darp.noaa.gov/publica.htm.)

Under the safeguards highlighted in the proposed amendments and as demonstrated in the Tampa Bay example, NOAA does not envision that the decisionmaking framework and procedural guidelines in the NCP will be undermined. Like EPA, NOAA believes that circumstances where trustees will wish to address residual oil will be few in number (see EPA Letter to NOAA, March 30, 1998, re: Reconsideration of Final Rule—Assessment of Natural Resource Damages (15 CFR Part 990); Request for Comments (63 FR 6846-6847, Feb. 11, 1998)), and that adequate controls are in place to ensure trustee coordination with the OSC.

NOAA believes it has answered the Court's concerns. Further, NOAA believes it has provided ample opportunity for all commenters to provide input on the Court's questions. Finally, NOAA believes it has adequately addressed the commenters' concerns.

On the issue of whether the lead Federal response agencies (the Coast Guard and EPA) concurred with NOAA's position in the proposed amendments, the Court asked that such concurrence be obtained in the event that NOAA was claiming “removal residual authority” per se ( see discussion on Removal Authority in the United States Court of Appeals for the District of Columbia Circuit, November 18, 1997). Since NOAA is not claiming such authority, it could be argued that no such concurrence is necessary. However, NOAA agrees that “emergency” restoration actions do require close coordination with the response agencies.

In sum, NOAA believes that the language provided in the proposed amendments is adequate. NOAA believes that the proposed language on restoration under §§ 990.26 and 990.53(b)(3)(i) affords the scope and protections needed to conduct actions consistent with removal and restoration authorities.

Comment: The one set of comments representing trustee interests found the proposed amendments constructive and sound, and recommended that these amendments be retained in the in the Final Regulation. The commenters note that the proposed amendments adequately and accurately address the Court's questions. The commenters support NOAA's position that effective restoration may require the trustees to eliminate or reduce exposure to oil.

The commenters specifically support NOAA's proposed amendments at § 990.26(a) and (b) regarding emergency restoration. However, the commenters felt that NOAA should address the “timeliness” in the implementation of emergency restoration actions in the proposed amendments. (NOAA asked for input on adding an explicit element, “at this time,” to § 990.26(b)(2) regarding the OSC's determination that residual oil does not merit further response, 66 FR 39465.) The commenters indicate that the OSC may be distracted on other more critical response issues ( e.g. , human health and safety) to make timely conclusions respecting the completion of a removal action. Such delays may require additional, costlier restoration. Thus, the commenters support the inclusion of the phrase “at that time” in NOAA's amendments as a reasonable solution.

Response: NOAA concurs with the commenters' observation that the proposed amendments to § 990.26(a) and (b) will facilitate the coordination of emergency restoration and removal actions. However, adding the phrase “at that time” to § 990.26(b)(2) might appear to undermine the OSC's authority. Modifying the NCP language respecting the OSC's responsibilities for removal actions is left to EPA (in consultation with other members of the National Response Team) as provided under section 1 of Executive Order 12777, 58 FR 54757. Removal of discharges is delegated to EPA and the Coast Guard under section 3 of the same Executive Order. Therefore, NOAA is declining to add such a time element relative to removal actions.

NOAA believes that the amendments sufficiently address the issue of residual oil remanded from the Court. This language was carefully crafted through extensive consultation with the Coast Guard and EPA. Therefore, NOAA is not persuaded that changes are needed. The amendments are incorporated in the Final Regulation.

The Court's decision on recovery of attorneys' costs as assessment costs discussed three issues. First, the Court noted that NOAA agreed that attorneys' costs incurred in pursuing litigation of a natural resource damages claim are not recoverable as assessment costs. In response to this point, NOAA proposed to amend to the definition of “Reasonable assessment costs” in § 990.30 by removing the word “enforcement” from the definition. ( General Electric Co., et al. , v. Commerce, at 776.)

Second, the Court noted that the parties in the case agreed that “trustees may recover assessment costs attributable to tasks that lawyers happen to perform but which others, such as engineers or private investigators, could have performed.” ( Id .) No amendment to the Final Regulation is necessary to address this point.

Finally, the Court declined to resolve the question of “whether trustees may recover costs stemming from legal work not directly in furtherance of litigation ( e.g. , pre-litigation legal opinions, title searches) that only lawyers could have performed.” ( Id .) Instead, the Court directed NOAA “to draw the precise line between recoverable and non-recoverable legal costs.” ( Id. ) In response to this direction from the Court, NOAA proposed amendments to § 990.30 to add a definition of “legal costs” that provides criteria for determining the scope of attorney activities that may be included in a trustee's claim for assessment costs.

The proposed amendments of July 31, 2001, focused on the explicit actions that trustees are authorized to perform under the Final Regulation or under OPA. When determining whether the costs of actions, performed for the purpose of assessment or development of a restoration plan, that could only be performed by attorneys, constitute reasonable assessment costs, the proposed amendment provided that trustees must consider the following criteria:

• Whether the action comprised all or part of an action specified either in this part or in OPA section 1006(c);

• Whether the action was performed prior to, or in the absence of, the filing of litigation by or on behalf of the trustee in question to recover damages; and

• Whether the action was performed by an attorney who was working for or on behalf of the trustee agency, as opposed to a prosecutorial agency.

The first criterion demonstrates that the action was directly in furtherance of natural resource damage assessment and restoration. The second and third criteria demonstrate that the action was not primarily in furtherance of litigation. If all of the above criteria are met, the costs associated with attorneys' actions are deemed assessment costs. If the criteria are not met, the trustee must explain why the action is an assessment action rather than an action performed for the primary purpose of furthering litigation.

The preamble to the amendments proposed on July 31, 2001, provided examples of common or routine assessment actions that may be most appropriately performed by trustee attorneys including, but not limited to:

• Providing written and oral advice on the requirements of OPA, these regulations, and other applicable laws;

• Preparing public notices, including the Notice of Intent to Conduct Restoration Planning issued to responsible parties and the Notice of Availability of Draft Restoration Plans;

• Developing and managing administrative records;

• Preparing binding agreements with potentially responsible parties in the context of the assessment, including study agreements, funding agreements, and restoration agreements;

• Preparing co-trustee cooperative agreements;

• Preparing formal trustee determinations required under the regulation;

• Determining requirements for compliance with other applicable laws; and

• Procuring title searches, title insurance, and/or conservation easements when property agreements are part of restoration packages.

On July 31, 2001, NOAA published proposed amendments to the Final Regulation to address the remanded issues, including the issue of trustee legal costs. 66 FR 39464. Only four comments were received on the proposed amendments: one comment from a coalition of State officials and three comments from industry representatives. These comments are summarized and addressed below. No comments were received on the issue of trustee legal costs in response to the February 11, 1998, request for public comments since that notice only dealt with the issue of residual oil (63 FR 6846).

Comment: The State officials and one industry commenter suggested that NOAA clarify the examples of trustee attorney actions given in the amendments proposed on July 31, 2001, and include these examples in the text of the Final Regulation.

Response: NOAA has provided more clarity to the examples and has included that language in the Final Regulation. Readers should note, however, that these examples are included simply as some of the various activities trustee agency attorneys might perform during the assessment and should not be taken as an exhaustive list of those activities that are authorized.

Comment: One industry commenter stated that the criteria in the proposed amendments are insufficiently detailed to exclude the recovery of attorney costs that would not appropriately be considered assessment costs. The commenter noted that NOAA did not draw a sufficiently bright line to exclude litigation nor other attorney costs that are incurred for essentially legal functions rather than damage assessment functions. The commenter also suggested that actions such as preparing binding agreements with potentially responsible parties or other agencies, such as study or funding agreements, are not essential to the performance of an assessment and are therefore not recoverable. The commenter stated that such agreements are substitutes for litigation and should be excluded from the definition of recoverable legal costs.

Response: NOAA believes that the criteria in the proposed amendments do provide clear guidance to define which attorney actions may be included as assessment activities. NOAA points out that such actions as preparing study and funding agreements are, in fact, essential to successful assessment work, particularly in the case of cooperative assessments where the parties want clear guidance on the bounds of the assessment. Instead of seeing such work as a substitute for litigation, NOAA believes such activities are essential to a successful assessment.

Comment: This same commenter noted that an attorney may review assessment documents solely for the purpose of preparing the documents to be used in litigation. The commenter stated that this review cannot be performed adequately by a non-attorney and is directly related to litigation preparation. The commenter requested that NOAA should add a criterion to exclude all litigation preparation costs.

Response: Review of an assessment document by an attorney during the course of an assessment may not be conducted for the sole purpose of preparing for litigation. If the assessment does not result in litigation at some future date it would likely be impossible to determine the “motives” of reviewers of documents. In addition, if litigation is avoided, the commenters' concern disappears. NOAA believes the current regulatory language gives clear guidance on how to define attorney actions performed for the purpose of assessment or development of a restoration plan so that a determination can be made as to which legal costs may be recoverable as reasonable assessment costs.

Comment: This same commenter also suggested that NOAA add the word “costs” after the word “legal” in the definition of “reasonable assessment costs” in § 990.30 of the final regulation.

Response: NOAA has added the word “costs” after both the word “administrative” and “legal” in § 990.30.

Comment: Finally, some commenters pointed out that a trustee potentially could recover attorney costs that fail the criteria, so long as the trustee explains why the attorney work “was not performed for the primary purpose of litigation.” The commenters stated that this language would allow recovery of costs if the secondary purpose of the action were to further litigation. These commenters suggested that NOAA should clarify the definition of “legal costs” to provide that any costs of attorney work that are intended in any manner to prepare for or assist in litigation or similar activities are not recoverable. One commenter suggested that NOAA should clarify that attorney costs, to be recoverable, must be for actions specified under section 1006(c) of OPA. Another commenter suggested that the language of § 990.30 definition of legal costs be revised by replacing subparagraph (2) with language requiring that costs must meet the criteria in subparagraph (1), thereby not allowing any costs that do not meet the three criteria.

Response: NOAA does not believe it is necessary to revise the final regulation to provide more clarity. The language allowing legal costs for actions “not performed for the primary purpose of litigation” was the phrase used by the Court and is included in the final regulation to avoid rigid adherence to the criteria in situations where assessment actions might not fit clearly within the three criteria listed, yet would still qualify as reasonable assessment costs. Responsible parties will still have the opportunity to challenge any costs they believe are not appropriate legal costs to include in reasonable assessment costs. NOAA points out that § 990.30 definition of “legal costs,” in subparagraph (1)(i), already requires that actions be conducted pursuant to section 1006(c) of OPA.

After considering the comments received on the July 31, 2001, proposed rule, NOAA has made the following changes to the regulatory language on attorneys' costs:

(1) Section 990.30 definition of legal costs has been revised in this final rule by adding a new subparagraph (3), which includes a non-exhaustive list of examples of attorney actions performed for the purpose of assessment or developing a restoration plan, in accordance with this rule.

(2) Section 990.30 definition of “reasonable assessment costs” has been revised in this final rule to insert the word “costs” after the words “administrative” and “legal.”

The amendments proposed on July 31, 2001, included technical and clarifying amendments to the Final Regulation. NOAA stated that it was not opening up the entirety of 15 CFR 990, but only those specific sections or subsections proposed. No comments were received on the technical and clarifying amendments. Therefore, the final regulation incorporates the following revisions:

Section 990.64(a) of the Final Regulation provides that where trustees' demands to implement or pay for restoration were denied by responsible parties, trustees could elect to file a judicial action for damages or seek an appropriation from the Oil Spill Liability Trust Fund (Trust Fund). On September 25, 1997, the Office of Legal Counsel for the U.S. Department of Justice (DOJ) determined that OPA does not require trustees to seek appropriations for uncompensated claims for damages. Instead, the U.S. DOJ found that damage claims could be presented to and paid by the Trust Fund without further appropriations. Thus, NOAA is amending the Final Regulation to reflect this legal determination. Therefore, under the final regulation, trustees have the option to seek recovery from the Trust Fund for uncompensated damages without further appropriations under section 1012(a)(4) of OPA, or seek an appropriation from the Trust Fund under section 1012(a)(2) of OPA.

Subsequent to publication of the Final Regulation, the D.C. Circuit Court of Appeals upheld provisions in the U.S. Department of the Interior's (DOI) regulations for natural resource damage assessments under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) that authorize recovery of indirect costs associated with restoration plans. Kennecott Utah Copper Corp. v. U.S. Dept. of the Interior, 88 F.3d 1191 (D.C. Cir. 1996). The Court found that DOI's provision met CERCLA's damages causation requirement because indirect costs were limited to those that were “necessary” to “support” implementation of a selected restoration option. Kennecott at 1224. The Court upheld recoverability of indirect costs of restoration in part due to the existence of procedural safeguards in DOI's regulation that help ensure the accuracy of such costs. These safeguards include describing selection of cost estimation methods in a publicly reviewable administrative record and restoration plan, and demonstrating that the method avoids double counting, and is feasible, reliable, cost-effective, and can be conducted at a reasonable cost. Finally, the Court held that requirements provided in DOI's regulation for calculation and application of an indirect cost rate sufficiently restrained trustee discretion, in that the regulation limits use of an indirect cost rate to situations where the costs of estimating indirect costs outweigh the benefits, and where the assumptions used in calculating the indirect cost rate have been documented.

The preamble to NOAA's Final Regulation indicated that indirect costs were recoverable assessment costs, but the Final Regulation did not include specific guidelines for determining indirect costs for either assessment or restoration costs. Based upon the ruling in Kennecott, NOAA is making technical clarifications to the Final Regulation to define the scope of indirect costs that are recoverable as “reasonable assessment costs” and as “restoration costs.” The Final Regulation incorporates the definition of indirect costs provided by the Office of Management and Budget ( see, “Managerial Cost Accounting Concepts and Standards for the Federal Government,” Statement of Federal Financial Accounting Standards No. 4 (SFFAS 4), Executive Office of the President, Office of Management and Budget, July 1, 1995). The Final Regulation contains similar procedural safeguards that apply to selecting a methodology to determine indirect costs as those in the DOI regulation. Section 990.27 of the Final Regulation lists standards for all methods that might be used in an assessment, including methods that might be used to calculate indirect costs, i.e. , cost calculation methods that are demonstrated to be reliable, valid, and cost-effective. Also, § 990.45 provides that relevant data on methods used should be included in the administrative record for the assessment. When using an indirect cost rate in lieu of calculating indirect costs on a case-specific bases, the basis of the indirect cost rate also should be documented in the administrative record.

Although various sections of the Final Regulation require selection of reliable and valid methods and require trustees to avoid double counting, NOAA believes that these requirements should be explicitly stated for purposes of cost accounting, providing added assurances that costs are accurate and appropriate. Therefore, NOAA is adding a new subsection (f) to § 990.62 of the Final Regulation to require that, when determining assessment and restoration costs incurred by trustees, trustees must use methods consistent with generally accepted accounting principles and with the requirements of § 990.27 of the Final Regulation.

NOAA is also providing that trustees must use methods consistent with generally accepted cost estimating practices and the requirements of § 990.27 of this part when estimating costs to implement a restoration plan. Therefore, NOAA is adding a new subsection (g) to § 990.62 of the Final Regulation to require that, when estimating costs to implement a restoration plan, trustees must use methods consistent with generally accepted cost estimating principles and with the requirements of § 990.27 of the Final Regulation.

The National Oceanic and Atmospheric Administration has determined that the amendments to the Final Regulation do not constitute a major federal action significantly affecting the quality of the human environment. Therefore, no further analysis pursuant to section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)) has been prepared. The Assistant General Counsel for Legislation and Regulation, in accordance with the Regulatory Flexibility Act, certifies to the Chief Counsel for Advocacy, Small Business Administration, that the amendments to the Final Regulation will not have a significant economic effect on a substantial number of small entities. The amendments to the Final Regulation are intended to make more specific, and easier to apply, the standards set out in OPA for assessing damages for injury to natural resources as a result of actual or threatened discharges of oil. The amendments to the Final Regulation are not intended to change the balance of legal benefits and responsibilities among any parties or groups, large or small. To the extent any are affected by the amendments, it is anticipated that all will benefit by increased ease of application of law in this area.

It has been determined that this document is not significant under Executive Order 12866. The amendments to the Final Regulation provide optional procedures for the assessment of damages to natural resources. It does not directly impose any additional cost.

It has been determined that this Rule does not contain information collection requirements that require approval by the Office of Management and Budget under 44 U.S.C. 3501 et seq.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. When we promulgated the rule we intended to either allow it to expire on June 15, 2002, or to cancel it if we made permanent changes before that date. We requested comments from the public and to date have not received any. In 67 FR 41177, June 17, 2002, we extended the effective period to September 30, 2002, to ensure the security of this facility and the safety of the public while determining whether a permanent rule is warranted. We have not determined whether a permanent rule is necessary; however, if we determine that a permanent rule is warranted, we will follow normal notice and comment rulemaking procedures, and a final rule should be published before March 31, 2003. Continuing the temporary rule in effect while considering promulgation of a permanent rule will help to ensure the security of this facility and the safety of the public during that period.

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 . It is not practicable to publish an NPRM because the security of the facility and the safety of the public needs to continue.

Although the Coast Guard has good cause to implement this regulation without engaging in the notice of proposed rulemaking process, we want to afford the maritime community the opportunity to participate in this rulemaking by submitting comments and related material regarding the size, scope and duration of the Regulated Navigation Areas, safety zones and security zones in order to minimize unnecessary burdens on waterway users. If you do so, please include your name and address, identify the docket number for this rulemaking [CGD05-01-071], indicate the specific section of this document to which each comment applies, and give the reason for each comment.

Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this temporary rule in view of them.

Due to the terrorist attacks on New York City, New York, and Washington DC, on September 11, 2001 and continued warnings from national security and intelligence officials that future terrorist attacks are possible, there is an increased risk that subversive activity could be launched by vessels or persons in close proximity to Calvert Cliffs Nuclear Power Plant. On October 3, 2001, Constellation Nuclear-Calvert Cliffs Nuclear Power Plant requested a limited access area to reduce the potential threat that may be posed by vessels that approach the power plant.

On February 28, 2002, the Coast Guard published a temporary final rule entitled “Security Zone; Calvert Cliffs Nuclear Power Plant, Chesapeake Bay, Calvert County, MD,” in the Federal Register (67 FR 9203). The temporary rule established a security zone around the Calvert Cliffs Nuclear Power Plant.

There is a continuing need for the protection of the plant. The initial extension of the temporary security zone surrounding the plant was only effective to 5 p.m. on September 30, 2002. As a result, the Coast Guard is further extending the effective date of the rule to 5 p.m. on March 31, 2003. There is no indication that the present rule has been burdensome on the maritime public; users of the areas surrounding the plant are able to pass safely outside the zone.

This temporary 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). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. Vessels may transit around the security zone and may be permitted within the security zone with the approval of the Captain of the Port or his or her designated representative.

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

This rule was not preceded by a general notice of proposed rulemaking and, therefore, is exempt from the requirements of the Regulatory Flexibility Act. Although this rule is exempt, we have reviewed it for potential economic impact on small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor near the Calvert Cliffs Nuclear Power Plant, Chesapeake Bay, Calvert County, Maryland.

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. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule will have a significant economic impact on it, please submit a comment to the office listed under ADDRESSES. In your comment, explain why you think it qualified and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

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

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

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

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

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

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

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

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

To help the Coast Guard establish regular and meaningful consultation and collaboration with Indian and Alaskan Native tribes, we published a notice in the Federal Register (66 FR 36361, July 11, 2001) requesting comments on how to best carry out the Order. We invite your comments on how this proposed rule might impact tribal governments, even if that impact may not constitute a “tribal implication” under the Order.

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

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

In Title 42 of the Code of Federal Regulations, Parts 400 to 429, revised as of October 1, 2001, § 413.86 is corrected, on page 525, by revising the designation (e)(4)(ii)(C)( 2 )(iii) to read (e)(4)(ii)(C)( 2 )( iii ) and by adding (e)(4)(ii)(C)( 2 ) introductory text, ( i ), and ( ii ) to read as follows:

Inspection of Public Comments: Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, call (410) 786-7195.

Section 4801 of Public Law 105-33, the Balanced Budget Act of 1997 (BBA), authorized coverage of the Program of All-inclusive Care for the Elderly (PACE) under the Medicare program. It amended title XVIII of the Social Security Act (the Act) by adding section 1894, which addresses Medicare payments and coverage of benefits under PACE. Section 4802 of the BBA authorized the establishment of PACE as a State option under Medicaid. It amended title XIX of the Act by adding section 1934, which directly parallels the provisions of section 1894.

The BBA built on the success of the PACE demonstration program. Section 603(c) of the Social Security Amendments of 1983 (Pub. L. 98-21), as extended by section 9220 of the Consolidated Omnibus Budget Reconciliation Act of 1985 (Pub. L. 99-272) authorized the original demonstration waiver for On Lok Senior Health Services in San Francisco. Section 9412(b) of Public Law 99-509, the Omnibus Budget Reconciliation Act of 1986, authorized us to conduct a demonstration project to determine whether the model of care developed by On Lok may be replicated across the country. The number of sites was originally limited to 10, but the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) authorized an increase to 15 demonstration sites.

The PACE demonstration program replicated a unique model of managed care service delivery for a group of very frail community-dwelling elderly, most of whom were dually eligible for Medicare and Medicaid benefits, and all of whom were assessed as being eligible for nursing home placement according to the standards established by their respective States. The PACE model of care includes as core services the provision of adult day health care and interdisciplinary team case management, through which access to and allocation of all health services is managed. Physician, therapeutic, ancillary, and social support services are furnished in the participant's residence or on-site at a PACE center. Hospital, nursing home, home health, and other specialized services are generally furnished under contract. Financing of the PACE model is accomplished through prospective capitation of both Medicare and Medicaid payments, and under the demonstration, programs gradually assumed full financial risk for all care provided to their enrolled participants.

The PACE demonstration program was operated under a Protocol published by On Lok, Inc., on April 14, 1995. A copy of the Protocol was included as an attachment to the interim final rule with comment period that was published in the Federal Register on November 24, 1999, to implement the PACE program (64 FR 66234.) As directed by sections 1894(f)(2) and 1934(f)(2) of the Act, we incorporated the requirements under the Protocol in the PACE regulation, to the extent consistent with the BBA provisions described throughout sections 1894 and 1934 of the Act. The November 24, 1999 PACE regulation was a comprehensive rule that addressed eligibility, administrative requirements, application procedures, services, payment, participant rights, and quality assurance. There are currently 24 approved PACE demonstration programs and two programs that have been approved as permanent PACE organizations. In accordance with section 901 of BIPA, all PACE demonstration programs must transition to permanent provider status by November 2003.

As noted above, the PACE demonstration program was operated pursuant to a Protocol developed by On Lok. The PACE Protocol provided authority for CMS and the State Agency to waive specific requirements of the Protocol, if, in their judgment, the intent of the requirements was met by the proposed alternative and safe and quality care would be provided. Written requests for waivers were required to be approved by CMS and the State before implementation of the proposed alternative. Flexibility was limited to the requirements in the section on service coverage and arrangement. That section includes: A requirement that the PACE organization provide all Medicare and Medicaid services and provide care 7 days per week, 365 days per year; a listing of required and excluded services; minimum services provided at the PACE Center; a requirement that each participant be assigned to a multidisciplinary team, as well as the composition and duties of the multidisciplinary team; and assessment and reassessment requirements. Flexibility was not authorized for other sections of the PACE Protocol, such as participant rights, enrollment and disenrollment, and administration.

Sections 1894(f)(2)(B) and 1934(f)(2)(B) of the Act give the Secretary the authority to waive regulatory provisions as follows:

The statute also specifies the following essential elements that may not be waived:

• The focus on frail elderly qualifying individuals who require the level of care provided in a nursing facility.

• The delivery of comprehensive, integrated acute and long-term care services.

• The multidisciplinary team approach to care management and service delivery.

• Capitated, integrated financing that allows the provider to pool payments received from public and private programs and individuals.

• The assumption by the provider of full financial risk.

In the November 24, 1999 interim final rule, we identified, as specific waivers that were intended to encourage development of PACE programs in rural and Tribal areas, waivers of the following three requirements:

• A prohibition on members of the governing body and their family members from having a direct or indirect interest in contracts with the organization (see § 460.68(c));

• A requirement that members of the multidisciplinary team primarily serve PACE participants (see § 460.102(g)); and

• A requirement that the primary care physician must be employed by the PACE organization (see § 460.102(g)). The regulation includes specific criteria for each waiver related to whether the PACE organization's service area is rural or Tribal, the unavailability of individuals who meet the three regulatory requirements listed above, and a requirement that the proposed alternative does not adversely affect the availability or quality of care furnished to PACE participants.

Our rationale for this rather limited view of the flexibility provision was based on our belief that all PACE demonstration programs were in compliance with the PACE Protocol and, therefore, would need to make only minor changes in their operations to meet the PACE regulatory requirements. Our intention was to allow some flexibility to promote PACE in rural and Tribal areas while maintaining consistency of requirements for other PACE programs. We intended to expand opportunities for flexibility to cover more requirements and provide more flexibility to all PACE organizations once we had gained sufficient experience with PACE and had implemented the program. In addition, we were guided by the fact that the Protocol, and thus the PACE regulation, had been proven effective for new organizations as they built their patient census and attained financial solvency.

We have since learned that although the early PACE demonstration programs initially complied with the Protocol, most of them modified the Protocol requirements as they expanded, using the flexibility provision. While many of these modifications were related to service coverage and arrangement provisions, many others were implemented that were not authorized by the flexibility clause in the Protocol. In addition, many of the later PACE demonstration programs exercised the flexibility clause in the Protocol in developing their programs, especially with regard to direct employment of staff. Finally, very few of the waivers were requested in writing or approved by CMS or the State before implementation.

BIPA modified the PACE program in the following three ways:

• Section 901 extended the transition period for the current PACE demonstration programs to allow an additional year for these organizations to transition to the permanent PACE program.

• Section 902 gave the Secretary the authority to grandfather in the modifications these programs had implemented as of July 1, 2000. This provision will allow the PACE demonstration programs to continue program modifications they have implemented and avoid disruptions in participant care where these modifications have been determined to be consistent with the PACE model. These sections are being implemented administratively.

• Section 903 specifically addressed flexibility in exercising the waiver authority provided under sections 1894(f)(2)(B) and 1934(f)(2)(B) of the Act. It allowed the Secretary to modify or waive PACE regulatory provisions in a manner that responds promptly to the needs of PACE organizations relating to the areas of employment and the use of community-based primary care physicians. Section 903 of BIPA also established a 90-day review period for waiver requests. Since the flexibility language is part of the statutory section dealing with regulations (sections 1894(f) and 1934(f) of the Act), we believe it was intended that waiver requirements be incorporated into the PACE regulations.

We note that although the PACE Protocol and the PACE regulation refer to a multidisciplinary team, it has become more common to regard the team in PACE as an interdisciplinary team to reflect the interactive and collaborative approach of the PACE care team. Therefore, we are amending the PACE regulation to replace the term multidisciplinary with interdisciplinary wherever it appears and will use that phrase in the preamble to describe the PACE team.

Section 460.102(f) of the PACE regulation requires that the following PACE interdisciplinary team members be employees of the PACE organization: primary care physician, registered nurse, social worker, recreational therapist or activity coordinator, PACE Center manager, home care coordinator, and PACE Center personal care attendants. This requirement is based on part IV.B.13.a. of the PACE Protocol that specifies that these team members must be employees of the PACE provider or PACE Center. (Employment of staff by the PACE Center is discussed in the next section of this preamble.) In addition, § 460.60 requires the PACE organization to employ the program director and the medical director.

We are no longer requiring that the PACE organization employ the interdisciplinary team, the program director or the medical director. Instead, the PACE organization may contract with these staff members, and we are expanding § 460.70 to include additional contract requirements. Finally, we are removing the specific waiver in § 460.102(g) for rural or Tribal organizations to contract for the primary care physicians.

The National PACE Association (NPA), an industry group representing the PACE demonstration programs and developing PACE programs, has indicated that the objectives of the Protocol with regard to employment are as follows:

• To assure that the same individuals provide care to the same participants over time (as opposed to a contractual relationship in which a different staff person may provide care from one month or even one day to the next); and

• To assure that the interdisciplinary team members are fully accountable to the PACE organization which has responsibility and is accountable for the entire range of PACE services.

NPA has indicated that contractual arrangements should be utilized only where it is consistent with continuity of care, and efficient and economical delivery of services. In addition, individual team members must be specified by name and work schedule.

We have become aware that most of the PACE demonstration programs have entered into contractual arrangements for interdisciplinary team members and key PACE staff such as the medical director. We have come to agree that there are reasonable circumstances where dedicated staff decide to contract rather than be employed by the PACE organization. For example, the medical director or primary care physicians may wish to maintain their employment with a hospital or academic institution while providing services to PACE participants. We believe that these arrangements may be done so as to be completely transparent to participants and have no impact on care coordination or service delivery.

Current requirements for contracted services are found in § 460.70. We are reorganizing and amending that section to include additional contract requirements for interdisciplinary team members or PACE administrative staff. Where these staff are not employed by the PACE organization, the contract must stipulate that the individuals: (1) Agree to perform all the duties related to their position in the PACE organization and specified in the PACE regulation; (2) participate in interdisciplinary team meetings as required; and (3) be accountable to the PACE organization.

Where the PACE organization contracts with another organization for interdisciplinary team staff, for example, with a rehabilitation agency that employs the physical therapist, the contract must also stipulate the name of the individual assigned to the PACE program and the schedule for attendance at the PACE Center. In this way, participants may be scheduled for attendance at the PACE Center to coincide with the schedule for the staff assigned to their care. Given the frailty of the population served by the PACE organization, we believe it is important that, where possible, services are provided to participants by the same core staff, whether employed directly by the PACE organization or provided via a contracting arrangement.

As mentioned above, our regulations currently require that the PACE program director and the medical director be employees of the PACE organization. In order to allow for contracting of the PACE program director and medical director, we are amending § 460.60(b) and (c) to require that the PACE organization employ these staff members directly or have contracts for these staff that meet the contracting requirements specified in § 460.70.

Finally, we are removing § 460.102(g), which allows CMS and the State administering agency to waive the employment requirement for the primary care physician and the requirement that the interdisciplinary team serve primarily PACE participants. Since the PACE organization may contract for primary care physicians in accordance with the requirements specified in § 460.70 as revised and other waivers are governed by § 460.26, these specific waiver provisions are no longer necessary.

The PACE Protocol at section IV.B.13.a. provides that the interdisciplinary team may be employed by the PACE organization or the PACE Center. In developing the PACE regulation, we did not address this issue because we believed that in all cases the PACE organization and the PACE Center were the same organization. We have learned that this change was made in the PACE Protocol in 1995 to reflect an operating arrangement implemented by one of the PACE demonstration organizations, On Lok Senior Health Services. In this arrangement, On Lok entered into a contractual relationship with another organization to provide all PACE Center services under which the interdisciplinary team is employed and managed by the contracting organization. On Lok remains responsible for all care provided at the Center and remains at risk for the healthcare needs of the participants attending this center. In addition, On Lok has retained many of the administrative responsibilities associated with PACE, for example, marketing and enrollment. Through this contractual relationship, On Lok has been able to expand PACE services to a different part of their service area without disrupting the care that traditionally had been provided by the other organization.

Since this approach was reflected in the PACE Protocol, we are amending the PACE regulation to allow PACE organizations to provide PACE Center services through contractual arrangements. Although we do not view this approach as a waiver authorized by BIPA, we are establishing specific waiver requirements for this approach consistent with the On Lok arrangement. We are more likely to allow PACE organizations to contract out PACE Center services when they have attained sufficient experience in delivering services and managing the risk associated with the frail elderly.

We are adding a new § 460.70(f) to identify the criteria that a PACE organization must meet to contract out PACE Center services. We are not inclined to approve a waiver for a PACE organization unless it is financially stable and has demonstrated competence with the PACE model by successful CMS and State onsite reviews and monitoring efforts. We specifically invite public comments on the appropriateness of these criteria.

We would expect the PACE organization to retain all key administrative functions including marketing and enrollment, quality assurance and program improvement, and contracting for institutional providers and other key staff. We note that, consistent with § 460.70(e)(5)(iv), all subcontracting arrangements by the PACE Center would need to be approved in writing by the PACE organization. The PACE Center may employ or contract for the team and provide PACE services in accordance with the PACE regulation. However, the PACE organization receives all payment from CMS and the State and remains responsible for all the care provided in these Centers. In addition, we emphasize that contracting out PACE Center services does not change the participants' relationship to the PACE organization. All participants, whether assigned to the PACE organization-owned and operated PACE Center or assigned to a PACE Center that contracts with the PACE organization, are enrolled with the PACE organization and are afforded all benefits and protections offered by the PACE organization.

On Lok is able to monitor the care provided in the contracted PACE Center through the sharing of electronic medical records. While we are not requiring electronic medical records as a condition of our approval, it will be necessary for a PACE organization wishing to pursue this type of arrangement to describe how it will monitor the care provided and perform all the administrative duties required by the PACE regulation.

Given the vulnerable frail population served by the PACE program and the increased opportunity for a PACE organization to contract out participant care services, it is important to reiterate the PACE organization's obligation to monitor the care furnished by direct participant care staff. This obligation applies not only to employees of the PACE organization, but extends to the care provided by contracted staff, including employees of organizations with which the organization contracts (for example, a home health agency, rehabilitation agency, nursing facility, transportation service, or staffing agency). It is especially important for the PACE organization to monitor the care provided in all settings, including the PACE Center and the participant's home, as well as in offsite locations such as physician offices and institutional providers to ensure quality care. To effectively monitor care provided outside the PACE Center, the PACE organization must be vigilant in following up on all unusual occurrences and complaints. In addition, the PACE organization must foster an atmosphere that promotes the voicing of participant complaints about quality of care to assist the PACE organization in monitoring the care provided by contracted staff and organizations.

Currently, § 460.66 requires the PACE organization to provide training to maintain and improve the skills and knowledge of each staff member for the individual's specific duties that results in his or her continued ability to demonstrate the skills necessary for the performance of the position. We are expanding this requirement by creating a new § 460.71 to identify PACE organization oversight requirements for PACE employees and contractors with direct patient care responsibilities. These requirements fall into two categories, that is, competency evaluation and staff and contractor requirements, and are listed as follows:

• The PACE organization must ensure that employees and contracted staff providing care directly to participants demonstrate the skills necessary for performance of their position.

• The PACE organization must provide each employee and all contracted staff with an orientation. The orientation must include at a minimum the organization s mission, philosophy, policies on participant rights, emergency plan, ethics, the PACE benefit, and policies and procedures relevant to each individual's job duties.

• The PACE organization must develop a competency evaluation program that identifies those skills, knowledge, and abilities that must be demonstrated by direct participant care staff (employees and contractors). The program must be evidenced as completed prior to performing participant care and on an ongoing basis by qualified professionals. The PACE organization must designate a staff person to oversee these activities for employees and work with the PACE contractor liaison to ensure compliance by contracted staff.

We note that the PACE organization may satisfy this requirement for contract staff through receipt of competency evaluation documentation from certain independent contractors where licensure requirements include a competency evaluation component, or from organizations or agencies that employ PACE staff.

The PACE organization must develop a program to ensure that all staff providing direct participant care services meet the requirements listed below. We revised § 460.70(e) to require contractors who furnish direct participant care to meet the requirements of § 460.71 as well. The PACE organization will verify that direct participant care staff or contractors meet the following requirements:

• Comply with any State or Federal requirements for direct patient care staff in their respective settings;

• Comply with the requirements of § 460.68(a) regarding persons with criminal convictions;

• Have verified current certifications or licenses for their respective positions;

• Are free of communicable diseases; and

• Have been oriented to the PACE program.

• Agree to abide by the philosophy, practices, and protocols of the PACE organization.

To implement section 903 of BIPA, we considered amending the November 24, 1999 PACE interim final regulations to identify each requirement that is eligible for waiver and provide separate waiver criteria for each requirement. However, we were concerned that amending the regulation for each waiver would: (1) Create a regulatory level of specificity that might make it difficult to apply to future requests for similar but not identical waivers; and (2) cause a significant delay between when the need for a waiver is identified and when it may be implemented.

As an alternative, we are amending the PACE regulation by adding §§ 460.26 and 460.28 to establish a process for a PACE organization to request waiver of regulatory requirements. As noted previously, the PACE Protocol and the November 24, 1999 PACE regulation have been proven effective as PACE organizations grow and reach financial solvency.

We have learned a great deal about variations in the model through the information we received in processing grandfathering requests under section 902 of BIPA and numerous discussions with the NPA, PACE organizations, and States. Allowing for waivers provides a unique opportunity for PACE organizations, the States, and CMS to experiment with new approaches within the structure of the PACE model. This process will allow for variations that achieve the intent of the regulatory provision while responding to the needs of PACE organizations to develop and expand within their States' long-term care delivery system. The PACE organizations will serve as an ongoing laboratory that over time will establish best practices that may ultimately replace the current regulatory requirements.

We realize that in order to foster innovation and creativity within the PACE program, PACE organizations must be granted some degree of flexibility in their operation and service delivery. However, we must balance this need for flexibility with our responsibility to ensure quality, cost effective care for all beneficiaries.

Based upon our experience and review of grandfathering requests under section 902 of BIPA, we realize we must consider two categories of waiver requests, that is, general waivers and conditional waivers subject to evaluation. They are discussed as follows:

A general waiver may be granted to a PACE organization that has successfully implemented a specific operating arrangement, for example, an operating arrangement approved under section 902 of BIPA. General waivers would continue indefinitely; however, approval may be withdrawn for good cause if periodic monitoring of the organization's operations and policies indicates participant care is being jeopardized, there is fiscal instability, or the goals of the PACE model are not maintained.

A conditional waiver, subject to evaluation, is a provisional waiver we would approve for a specific period of time to a new or experienced organization. During the conditional period, the PACE organization would need to submit specific data, that we prescribed, that would allow us to monitor and evaluate the conditional waiver to determine whether the waiver may become permanent. This category of waiver may include the following scenarios:

(a) A request for waiver without which a PACE organization would be prevented from entering the program. For example, if a prospective PACE organization has been unable to hire or contract with a social worker with a master's degree, we may consider approving a conditional waiver request to allow a social worker with a baccalaureate degree to operate in this capacity until a qualified social worker is hired. This waiver would only be in effect until the PACE organization could hire or contract for an appropriate staff member.

(b) A request for approval of an arrangement with which a PACE organization does not have any experience. We want to encourage creative approaches to improving the PACE model and view conditional waivers as a responsible way to balance the need of a PACE organization with protection of participant health and safety. We do need to be cautious in approving arrangements in which the PACE organization does not have a proven record of success. In this case, we may limit the number of participants exposed to the waiver or approve the waiver for a limited period of time or at a specific PACE Center until we are assured through evaluation that (1) The intent of the regulation is met; and (2) the approach is not inconsistent with nor impairs the essential elements, objectives, and requirements of PACE. At that time, we may approve a general waiver so that the PACE organization may expand the arrangement to other PACE Centers it manages without jeopardizing participant care.

Each of the conditional waivers will be subject to periodic monitoring. A PACE organization approved for a conditional waiver would need to submit the prescribed data at specified intervals. CMS intends to establish elements for evaluating the conditional requests. This evaluation would serve a dual purpose. It would allow CMS to monitor the impact on participant care as well as enable us to determine if any permanent changes to PACE should be implemented through regulations. In addition, we may provide technical assistance to other PACE organizations requesting a similar waiver.

To obtain a waiver, a PACE organization must provide a detailed description of how its proposed modification differs from the regulatory requirement and describe how it meets the intent of the regulatory provision. The burden is on the PACE organization to explain why a waiver is needed to start up or expand their program. Where a PACE organization has not completed the trial period, attained financial solvency, and demonstrated competence with the PACE model as evidenced by successful CMS and State onsite reviews and monitoring activities, it will be necessary for the organization to explain how the waiver is necessary to meet those objectives. For a new organization, it will be necessary for the organization to explain why a waiver is needed for the organization to begin serving participants.

Consistent with the process developed for initial PACE provider applications, all waiver requests must be submitted to the State administering agency for initial review. The State administering agency would forward the waiver request to CMS along with any concerns or conditions they may have regarding the waiver. We will not accept waiver requests directly from PACE organizations. Waiver requests submitted with an initial application process must be prepared as a separate document. These requests will be reviewed simultaneously and in conjunction with the application. Where an existing PACE organization is requesting a waiver, the request must be submitted through the State to the CMS address for PACE applications indicated on the PACE homepage (www.cms.hhs.gov/PACE). We intend to process waiver requests as expeditiously as possible in order to be responsive to the needs of new organizations to develop their programs and to the needs of mature organizations as they expand.

Section 903 of BIPA directs us to approve or deny a request for a modification or waiver no later than 90 days after the date of receipt. We are clarifying in § 460.28(b) that the date of receipt is the date the request is delivered to the address designated by CMS. We note that there is no statutory authority to stop the 90-day clock if additional information is necessary to make a determination on a waiver request. Thus, it is in the PACE organization's best interest to provide all pertinent information relevant to their request. Where additional information is necessary, the CMS PACE manager will inform the PACE organization as early as possible in the review process. The PACE organization will then be responsible for submitting the additional information in a timely enough manner to allow us to evaluate the additional information and make a determination on the waiver request within the allotted 90 days. If the reply from the PACE organization is not received in a timely manner, we would have to deny the request. The PACE organization may then reapply for the waiver, starting a new 90-day clock.

Consistent with sections 1894 and 1934 of the Act, we are specifying in § 460.26(c) the following requirements that must not be waived:

(1) A focus on frail elderly qualifying individuals who require the level of care provided in a nursing facility;

(2) The delivery of comprehensive, integrated acute and long-term care services;

(3) The interdisciplinary team approach to care management and service delivery;

(4) Capitated, integrated financing that allows the provider to pool payments received from public and private programs and individuals; and

(5) The assumption by the provider of full financial risk (we note that assuming full financial risk does not preclude an organization from utilizing reinsurance, stop-loss protection, or other mechanism to meet its financial obligations).

In addition to these five provisions, the Secretary will not grant waivers that are inconsistent with or would impair the essential elements, objectives, and requirements of sections 1894 and 1934 of the Act.

As noted previously, the November 24, 1999 PACE regulation was a comprehensive document that included many provisions that are not appropriate for waiver. For example, subpart B of the PACE regulation describes the types of entities that may submit PACE applications and the process for submission of applications. Since these requirements reflect statutory requirements and our application process, no waiver or modification is appropriate. Likewise, subpart C of the November 24, 1999 PACE regulation describes the terms and content of the PACE program agreement. Although we agree that it would be easier to manage PACE program agreements without the significant detail, the content of the PACE program agreement is specifically required by statute. Thus, no waiver or modification is appropriate.

Regarding other subparts of the PACE regulation, we view many, but not all, of the requirements as appropriate for waiver or modification. For example, while we may approve a waiver regarding the organization's structure or division of responsibilities amongst staff, we would not be inclined to waive infection control requirements that are standard precautions established by the Centers for Disease Control and Prevention.

We note that providing services through contracts rather than through direct employment of staff is the type of flexibility most often requested by PACE organizations and the NPA and will be permissible without waiver.

In addition to the statutorily excluded requirements specified in sections 1894(f)(2)(B) and 1934(f)(2)(B) of the Act, we believe there are other requirements that distinguish the PACE benefit. For example, health care is focused at a PACE Center; the interdisciplinary team is composed of certain health care professionals that manage all the health care provided to participants; a comprehensive assessment by the interdisciplinary team is conducted before admission into the PACE program; and reassessment occurs at least every 6 months or whenever there is a significant change in a participant's health status. Further, we believe that PACE participants are entitled to the same patient rights' protection available in the Medicare or Medicaid fee-for-service or managed care programs. Therefore, we will not approve waiver or significant modification of these requirements.

Two waiver issues specifically mentioned in section 903 of BIPA are requirements related to employment and the use of community-based primary care physicians. An example of this would be to allow a PACE organization to provide primary care through community physicians operating independent of the PACE program, that is, physicians who do not participate in interdisciplinary team meetings. This approach is part of our demonstration project currently underway in Wisconsin. The evaluation of the demonstration will not be completed until 2005. As this demonstration has developed, the sites have modified their use of community-based physicians over time. We believe that further testing and refinement of this approach is needed. We will follow the evaluation of this demonstration to determine the optimal policies and procedures to require for PACE organizations wishing to adopt this option.

Another example is the use of satellite locations, where required PACE Center services (and the interdisciplinary team services) are provided at various locations. Although services may be provided at various locations currently, we are concerned that routinely dispersing service delivery will fundamentally change the PACE model, especially the focus of services at the PACE Center and care management through the interdisciplinary team.

Since this rule will establish a process for submission and approval of waiver requests, we are removing the restrictive waiver provisions that were limited to rural and Tribal organizations, that is, § 460.68(c) regarding direct or indirect interest in contracts, and, as noted previously, the two waivers in § 460.102(g) related to employment of the primary care physician and the requirement that the interdisciplinary team primarily serve PACE participants. Although we are deleting the specific waivers that were intended to encourage development of PACE in rural or Tribal areas, we continue to recognize the special need for flexibility for these areas and remain committed to allowing waivers to promote PACE in medically underserved areas. Deletion of the specific waiver language is intended to provide greater flexibility within the overall PACE structure. We remain committed to working with rural and Tribal communities to help them address the challenges of developing successful PACE programs. Organizations that seek waiver of these or any other regulatory requirements would follow the requirements specified in § 460.26.

We note that a PACE organization requesting a waiver of the prohibition on direct or indirect interest in contracts must develop policies and procedures for disclosure of financial interest to the governing body, establish recusal restrictions, and a process to record recusal actions for review by CMS and the State administering agency. The PACE organization must describe its disclosure and recusal policies in its waiver request.

We received a total of 27 comments on the November 1999 interim final regulation (64 FR 66234), many of them concerning the waiver provisions published at §§ 460.68 and 460.102.

Comment: Most of the commenters expressed concern that the regulation is too prescriptive and limits flexibility and innovation and that the waiver provisions in §§ 460.68 and 460.102 of the regulation were too restrictive. The commenters argued that developments during the PACE demonstration program had led to alternative practices (primarily associated with contracting flexibility) that were not reflected in the November 1999 interim final regulation. They urged CMS to allow alternative approaches to meeting the regulatory intent and specifically recommended that we broaden the limited waivers provided in the regulation targeted to rural and Tribal organizations to permit waiver of additional requirements by all PACE organizations. In addition, section 903 of BIPA provided us with additional guidance concerning both the practices of longstanding PACE demonstration programs (grandfathering) and new organizations which may apply to become PACE organizations.

Response: This interim final regulation is a response to the portion of the November 1999 regulation that dealt with waivers and flexibility. It responds to the concerns raised in the public comments by establishing a process through which approved PACE organizations, as well as applicants, may request a waiver of regulatory requirements (§ 460.26) and allow expanded contracting opportunities (§ 460.70). Through the waiver process, we hope to learn about any barriers the PACE requirements create in developing new organizations, especially those in medically underserved areas, and expanding existing PACE programs.

Once we have completed the transition of PACE demonstrations to permanent provider status and gained sufficient experience with the waiver process, we intend to develop a final rule to revise the PACE regulation and respond to all the public comments we received on the November 1999 interim final regulation as well as any public comments submitted in response to publication of this regulation.

The regulation amends part 460 by replacing the term “multidisciplinary” with “interdisciplinary” wherever it appears to reflect the interactive and collaborative approach of the PACE team.

We are amending this section to clarify that subpart B also establishes a process for a PACE organization to request a waiver of regulatory requirements in order to provide for reasonable flexibility in adapting the PACE service delivery model to the needs of particular organizations (such as those in rural areas).

We are removing and reserving paragraph (a)(2) to clarify that, although CMS may begin review of PACE organization applications, we may sign a program agreement only with a PACE organization located in a State with an approved State plan amendment electing PACE as an optional benefit under its Medicaid State plan.

In accordance with the requirements in section 903 of BIPA, we are adding this section to subpart B to establish a process for a PACE organization to request waiver of regulatory requirements and to list provisions that are statutorily excluded. This process is described in section II.E. of this preamble.

As required by section 903 of BIPA, we are adding this section to subpart B to specify the time limit for notification to PACE organizations of our decisions on waiver requests and to state that we may withdraw approval of a waiver for good cause. This process is described in section II.E. of this preamble.

We are revising paragraph (b) to reflect that the PACE program agreement is a 3-party agreement that is signed by CMS, the State administering agency, and the PACE organization. Also, we are adding a new paragraph (c) to clarify that we may sign a program agreement only with a PACE organization that is located in a State with an approved State plan amendment electing PACE as an optional benefit under its State plan.

In order to allow for contracting of a PACE program director and medical director described in section II.B. of this preamble, we are amending paragraphs (b) and (c) to require that the PACE organization employ these staff members directly or have contracts for these staff that meet the contracting requirements specified in § 460.70.

As discussed in section II.E. of this preamble, we are removing paragraph (c) and amending paragraph (b) by removing the cross reference to paragraph (c).

As described in section II.B. of this preamble, we are amending paragraph (e) to include additional contract requirements where the PACE organization chooses to contract for interdisciplinary team members or key administrative staff. In addition, we are adding a new paragraph (f) to include specific contract requirements where the PACE organization chooses to contract for PACE Center services. These changes are described in section II.C. of this preamble. Finally, we are amending paragraph (b)(1)(i) to clarify that an institutional contractor, such as a hospital or skilled nursing facility, must meet the Medicare or Medicaid participation requirements. However, where the PACE organization is supplementing its own staff to provide services in the home or at the PACE Center, certain staffing agencies that may not be Medicare certified providers may be used as long as the staff and the agency meet applicable State licensure requirements.

In consideration of the vulnerable population served by PACE, we are adding this section to identify PACE organization oversight requirements for PACE employees and contractors with direct patient care responsibilities. These requirements are described in section II.D. of this preamble.

We are amending paragraph (d)(2)(iii) to clarify that interdisciplinary team members must document changes of a participant's condition in a participant's medical record consistent with the PACE organization's documentation policies. This will ensure that only designated team members have access to patients records. Also, in consideration of the expanded contracting opportunities described in section II.B. of this preamble, we are removing paragraph (f) that requires members of the PACE interdisciplinary team to be employed by the PACE organization. Finally, we are removing paragraph (g) that allows CMS and the State administering agency to waive the employment requirement for the primary care physician and the requirement that the interdisciplinary team serve primarily PACE participants. Since the PACE organization may contract for primary care physicians in accordance with the requirements specified in § 460.70 (described in section II.B. of this preamble) and other waivers are governed by § 460.26 (described in section II.E. of this preamble), these specific waiver provisions are no longer necessary. We are amending paragraph (d)(3) by removing the cross reference to paragraph (g).

Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed and the terms and substance of the proposed rule or a description of the subjects and issues involved. However, section 1894(f)(1) if the Act specifically permits the Secretary to issue interim final or final regulations to carry out sections 1894 and 1934 of the Act. Therefore, we are issuing this final rule on an interim basis with a 60-day comment period.

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

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

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

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

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

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

Section 460.26(b) requires a PACE organization or prospective PACE organization to submit a written request to obtain CMS approval of its request for waiver or modification of a PACE regulatory requirement. Section 460.26(a) requires that the request be submitted through the State administering agency.

The burden associated with this requirement is the time and effort to develop and submit a waiver request to CMS. We estimate that 25 entities will apply per year and that each entity will take 3 hours to complete the requirements of this section for a total annual burden of 50 hours.

In addition, § 460.26(a) requires that a waiver request must be submitted to the State administering agency of the State in which the program is located for review prior to submittal to CMS.

The burden associated with this requirement is the time and effort for a State to review and submit waiver requests to CMS indicating that it approves the waiver requests. We estimate that 25 States will each take 1 hour to complete these requirements for a total annual burden of 25 hours.

In summary, § 460.71(a) requires a PACE organization to develop a competency evaluation program to ensure that direct participant care staff (employees and contractors) have the skills, knowledge, and ability to perform the duties associated with their positions.

The burden associated with this requirement is the time and effort to develop and maintain a competency evaluation program, perform evaluations including evaluation of all current staff, and document the results. We estimate that each organization will spend 3 hours developing the program, 50 hours implementing the program for all current staff, and 50 hours maintaining the program and verifying the qualifications and competency of new staff and contractors. There will be approximately 54 PACE organizations with approximately 100 contracted staff for a total annual burden of 2700 hours.

Section 460.102(d)(2)(iii) requires the documention of any changes in a participant's condition in the participant's medical record consistent with documentation polices established by the medical director.

We believe that the burden associated with this ICR is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with these requirements would be incurred by persons in the normal course of their activities.

We have submitted a copy of this interim final with comment rule to OMB for its review of the information collection requirements described above. These requirements are not effective until they have been approved by OMB.

If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare and Medicaid Services, Office of Information Services, Security and Standards Group, Division of CMS Enterprise Standards, Room C2-26-17, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: John Burke, CMS-1201-IFC, and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Brenda Aguilar, HCFA Desk Officer.

We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, non-profit organizations and government agencies. Most hospitals and most other providers and suppliers are small entities, either by non-profit status or by having revenues of $6 to $29 million or less annually. For purposes of the RFA, all PACE providers are considered to be small entities. Individuals and States are not included in the definition of a small entity.

Section 1102(b) of the Social Security Act (the Act) requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. Such an analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. This rule will not affect a significant number of small rural hospitals.

This interim final rule will affect a very limited number of small non-profit entities that are operating, or seek to operate, a PACE program and request waiver of regulatory requirements for startup or expansion. The rule will indirectly affect Medicare beneficiaries and Medicaid recipients who may qualify for a PACE program and who might wish to enroll in one in their geographic area, because it may affect the availability of those programs. A typical mature PACE program maintains an enrollment of about 200 to 300 individuals.

While we do not have data on which to base an estimate of overall costs or savings to the Medicare and Medicaid programs, we believe that any incremental difference would be so small as to be negligible. Payment rates for PACE are adjusted so that the total payment level is less than the projected payment that would have been made if the participants were not enrolled in PACE. Thus, the overall effect of the PACE program should be a slight savings for this small population. Approved PACE organizations that request waivers to support expansion activities or prospective organizations that request waivers to support start up may incur a minimal cost and burden associated with waiver requests.

If this rule were not issued, PACE programs would be unable to implement modifications to PACE regulatory requirements, potentially impeding their ability to start up or expand their programs.

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

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies anticipate costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This interim final rule will not mandate any requirements for State, local, or tribal governments nor would it result in expenditures by the private sector of $110 million or more in any 1 year.

Under Executive Order 13132, this regulation will not significantly affect the States beyond what is required and provided for under the BBA. It follows the intent and letter of the law and does not usurp State authority beyond what the BBA requires. This regulation describes the processes that must be undertaken by CMS, the States, and PACE organizations in order to implement the flexibility afforded by section 903 of BIPA.

As we explained in the November 1999 interim final regulation (64 FR 66235), sections 4801 and 4802 of the BBA clearly describe a cooperative relationship between the Secretary and the States in the development, implementation, and administration of the PACE program. The BIPA amendments reflect this partnership between CMS and the State administering agency. However, section 903 of BIPA does not specifically provide for consultation or agreement by the States in making waiver determinations. Nonetheless, it is our intention to engage the State in discussion regarding waiver requests and to require the PACE organization to submit a waiver request through the State administering agency.

In addition, we continue to obtain State input in the early stages of policy development through conference calls with State Medicaid Agency representatives. The calls, which began after enactment of the BBA, have been very productive in understanding the variety of State concerns inherent in implementing the PACE program. We are committed to continuing this dialogue with States after publication of this regulation to ensure this cooperative atmosphere continues as we complete the transition of the current PACE demonstration sites to full provider status and expand access to the PACE benefit.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

I. Background

The rules governing procedures for hearings and appeals under the Surface Mining Control and Reclamation Act of 1977 (SMCRA), 30 U.S.C. 1201-1328 (2000), that appear in Title 43, Part 4, Subpart L, of the Code of Federal Regulations (CFR) have been adopted by the Office of Hearings and Appeals (OHA) at various times since that statute was enacted. Over the years some of the addresses, phone numbers, cross references, and language of those rules have become out of date. For example, the Office of Surface Mining Reclamation and Enforcement (OSM) adopted final rules in December 2000, 65 FR 79582 (Dec. 19, 2000) in Title 30 CFR. The result is that the language and section numbers in OHA's existing rules in 43 CFR part 4, subpart L, that refer to OSM's rules do not correspond to the language and section numbers in OSM's recent rules. The final rules OHA adopts today are intended only to make technical amendments to the rules in Subpart L so that they will conform to the rules in 30 CFR and otherwise be up to date.

Some rules in 43 CFR, Part 4, Subpart L, use the abbreviation “OSM” for the Office of Surface Mining Reclamation and Enforcement and some rules use “OSMRE.” As OSM's definition in 30 CFR 700.5 makes clear, the two abbreviations have the same meaning. The definition in 43 CFR 4.1100(e) is revised to correspond to OSM's definition.

The cross reference in 43 CFR 4.1101(a) to the jurisdiction of the Board, “as set forth in 43 CFR 4.1(4),” is out of date. In 1982, the Interior Board of Surface Mining and Reclamation Appeals (IBSMA) was abolished and jurisdiction over appeals under SMCRA was transferred to the Interior Board of Land Appeals (IBLA). See 49 FR 7564-7565 (March 1, 1984); 48 FR 22370 (May 18, 1983). IBLA's jurisdiction is now set forth in 4.1(b)(3), so 4.1101(a) is amended to read “as set forth in 43 CFR 4.1(b)(3).”

In addition, the reference in 4.1101(a) to 43 CFR 4.21(c) is out of date. When 4.1101 was adopted in 1978, 4.21(c) dealt with requests for reconsideration. 43 CFR 4.21 was amended in 1993, however, and 4.21(c) became 4.21(d). 58 FR 4939, 4941 (Jan. 19, 1993). The reference in 4.1101(a) is revised to conform to the 1993 amendment of 4.21.

Several rules have been added to Subpart L since that subpart was originally promulgated in August 1978, i.e. , sections 4.1350-4.1356, 4.1360-4.1369, 4.1370-4.1377, 4.1380-4.1387, and 4.1390-4.1394. Some subjects covered in the rules that have been added are not specifically included in the list of subjects under the Board's jurisdiction in 4.1101(a)(1)-(7). The subjects not included by the rules that have been added to Subpart L are therefore added to the list in 4.1101(a) as (8)-(11) and previous sections (8) and (9) are renumbered (12) and (13).

Some of the jurisdictions, addresses, and telephone numbers of the offices of the Office of the Solicitor that are to receive service of a document under 43 CFR 4.1109(a)(1) and (a)(3) have changed. 4.1109(a)(2) is amended to reflect these changes.

The rules in 4.1190-4.1196 of Subpart L, adopted in 1978, provide procedures to review an OSM order to show cause why a permit should not be suspended or revoked under the rule adopted by OSM in December 1977 for the initial regulatory program. See 30 CFR 722.16. The rules in Subpart L have not been revised since OSM adopted its permanent regulatory program rule governing such proceedings in 1979. 30 CFR 843.13. OSM revised that rule in 1982. The rules in 4.1190-4.1196 are revised to adjust the timing of the filing of an OSM Director's order with OHA (4.1190(a)); to delete references to the initial regulatory program rule (4.1192 and 4.1194); to add a requirement for notice of a hearing contained in 30 CFR 843.13(b) (new 4.1193); and to redesignate former 4.1193, 4.1194, 4.1195, and 4.1196 as 4.1194, 4.1195, 4.1196, and 4.1197.

It is 30 CFR Part 865 rather than Part 830 that contains the OSM regulations governing review of alleged discriminatory actions. Therefore, the references in 4.1200 and 4.1204 to the regulations in 30 CFR are amended.

The telephone numbers of the OSM field offices that are to receive telephone notice of an application for review under 4.1266(b)(2), and the states served by those field offices, are updated.

Since Subpart L was adopted in 1978, OSM has added Part 845 to 30 CFR. 43 CFR 4.1270(f) is therefore amended to refer to this part as well as part 723.

43 CFR 4.1276(a), which provides that a party may move for reconsideration of a Board decision, refers to 43 CFR 4.21(c). When 4.21 was amended in 1993, paragraph (c) was redesignated paragraph (d). 58 FR 4939, 4941 (Jan. 19, 1993). 4.1276(a) is therefore amended to refer to subsection (d).

In December 2000, OSM adopted 30 CFR 774.11, “Post-permit issuance requirements for regulatory authorities and other actions based on ownership, control, and violation information.” That regulation requires OSM to serve a “preliminary finding of permanent permit ineligibility” under section 510(c) of the Act if an applicant or operator controls or has controlled surface coal mining and reclamation operations with a demonstrated pattern of willful violations and the violations are of such nature and duration with such resulting irreparable damage to the environment as to indicate an intent not to comply with the Act, its implementing regulations, the regulatory program, or a permit. In making such a finding OSM will only consider control relationships and violations that would make or would have made the applicant or operator ineligible for a permit under 30 CFR 773.12(a) and (b). 30 CFR 774.11(c), 65 FR 79582, 79667 (Dec. 19, 2000). An applicant or operator may request a hearing on a preliminary finding of permanent permit ineligibility under 43 CFR 4.1350 through 4.1356. 30 CFR 774.11(d).

The OHA rules referred to in 30 CFR 774.11(d) that provide procedures for review of a preliminary finding under section 510(c) of the Act, 4.1350-4.1356, were adopted in 1987 and 1991 and their language does not conform to the language adopted in OSM's more recent rules. OHA's rules in 4.1350, 4.1351, 4.1352, and 4.1355 are therefore amended to do so.

The rules OSM adopted in December 2000 provide that OSM is to provide written notice of its decision that an applicant is ineligible for a permit under section 510(c) of the Act. The notice is to tell the applicant of its appeal rights under 30 CFR Part 775 and 43 CFR 4.1360 through 4.1369. 30 CFR 773.12(e), 65 FR 79582, 79664 (Dec. 19, 2000).

OHA's regulations in 43 CFR 4.1360-4.1369 set forth the procedures for administrative review of OSM decisions concerning permits. 4.1360, however, does not list review of an OSM decision under 30 CFR 773.12 that an applicant is ineligible for a permit. A new subsection (e) is therefore added to 4.1360 to include such a decision.

When OSM published its regulations in December 2000, it revised 30 CFR 773.21-773.23 concerning improvidently-issued permits. See 65 FR 79582, 79665-79666 (Dec. 19, 2000). In doing so, OSM changed the subsections under which it would issue notices of proposed suspension or rescission and notices of suspension or rescission. Therefore, the cross references in 43 CFR 4.1370-4.1372 to OSM's regulations need to be changed to reflect the correct subsections, and 43 CFR 4.1372(a)(1), 4.1374(a) and 4.1376(a) are amended to refer to both types of notices.

In its December 2000 regulations, OSM eliminated 30 CFR 773.24, revised 30 CFR 773.25, and added 773.26-773.28 concerning challenges to an OSM “ownership or control listing or finding.” See 65 FR 79582, 79666-79667 (Dec. 19, 2000). Any person who receives a written decision from OSM in response to a challenge to a listing or finding of ownership or control “and who wishes to appeal that decision, must exhaust administrative remedies under the procedures at 43 CFR 4.1380 through 4.1387 or, when a State is the regulatory authority, the State regulatory program counterparts, before seeking judicial review.” 30 CFR 773.28(e).

These changes in OSM's rules require conforming changes in OHA's rules that provide procedures for review of such OSM decisions. 43 CFR 4.1380 and 4.1381(a) are amended accordingly.

On December 17, 1999, OSM adopted rules redefining when a person has valid existing rights (VER) to conduct surface coal mining operations on lands listed in section 522(e) of the Act, 30 U.S.C. 1272(e); establishing procedures for submitting requests for VER determinations; modifying the exception from the statutory limitations and prohibitions for existing operations; and revising the procedures for compatibility findings for surface coal mining operations on federal lands in national forests. 64 FR 70766 (Dec. 17, 1999).

OHA's rules for obtaining review of OSM determinations under section 522(e) were adopted in 1987 and 1991. The existing 43 CFR 4.1390 states that those rules “set forth procedures for obtaining review pursuant to 30 CFR 761.12(h) of a determination by OSM that a person holds or does not hold a valid existing right.”

The preamble to OSM's December 1999 rules explained that 30 CFR 761.12 was reorganized and recodified. Former 761.12(h) is now 761.16(f). 64 FR 70766, 70804 col. 2 (Dec. 17, 1999). 761.16(f) provides for administrative review of an OSM determination that a person does or does not have valid existing rights. This rule therefore amends 4.1390 to change the reference from 30 CFR 761.12 to 761.16.

Existing § 4.1390 also states that OHA's rules provide procedures for review of OSM determinations “that surface coal mining operations did or did not exist on the date of enactment of the Act, on lands where operations are prohibited or limited by section 522(e) of the Act.”

In December 1999, OSM explained that it removed “the portion of former 30 CFR 761.12(h) that provided for administrative appeals of existing operation determinations':

Finally, existing § 4.1390 states that the rules set forth the procedures “for obtaining review pursuant to 30 CFR 761.12(h) of a determination by OSM * * * that surface coal mining operations may be permitted within the boundaries of a national forest in accordance with section 522(e)(2).” This statement was adopted in error. The former 30 CFR 761.12(h) did not refer to such determinations. Under section 522(e)(2), it is the Secretary, not OSM, who makes a finding “that there are no significant recreational, timber, economic, or other values which may be incompatible with such surface mining operations and * * *.” See 30 CFR 761.11(b), 761.13. OSM's December 1999 rules make clear that this authority is reserved by the Secretary. 30 CFR 740.4(a)(5), 745.13(p). The IBLA is delegated authority to decide appeals from decisions on behalf of the Secretary; it does not have authority to review decisions made by the Secretary. See Alamo Ranch Co., Inc., 135 IBLA 61, 67-68 (1996). This rule therefore amends 4.1390 to remove the reference to compatibility determinations under 30 CFR 761.11(b), 761.13.

Section 4.1391(a) is revised to reflect the amendments to 4.1390.

A VER determination may either be made independently or in conjunction with a decision on an application for a permit or a permit boundary revision. 30 CFR 716.16(b). It would not be made in connection with an application for a permit renewal or for the transfer, assignment, or sale of permit rights, nor does section 522(e) apply to coal exploration. 64 FR 70766, 70819 (Dec. 17, 1999). Therefore, 4.1391(b)(1) and (2) are revised to delete references to those applications.

Because one need not be a permit applicant to request a VER determination, 4.1394(a) is revised to refer to “a person who requested the determination.” 4.1394(b) is revised to reflect the scope of 4.1390, as amended.

In accordance with the criteria in Executive Order 12866, this document is not a significant rule. The Office of Management and Budget has not reviewed this rule under Executive Order 12866.

a. This rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, competition, jobs, the environment, public health or safety, or other units of government. A cost-benefit and economic analysis is not required. These amended rules will have virtually no effect on the economy because they are simply providing updated addresses and phone numbers and correcting references to and quotations from other regulations.

b. This rule will not create inconsistencies with or interfere with other agencies' actions. These rules will conform the rules in 43 CFR part 4, subpart L, with current information about other agencies, thereby making the rules consistent rather than inconsistent with actions that have been taken by other agencies.

c. This rule does not alter the budgetary effects of entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. These rules have to do only with the procedures for hearings and appeals of OSM decisions, not with entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients, and they make no substantive changes in the procedures.

d. This rule does not raise novel legal or policy issues. Because these rules only make technical, conforming changes to details such as addresses and phone numbers applicable to procedures for hearings and appeals, they raise no policy or legal issues, novel or otherwise.

The Department of the Interior certifies that this rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The changes in addresses, phone numbers, citations to and quotations from other rules will have no effect on small entities. A Small Entity Compliance Guide is not required.

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

a. This rule does not have an annual effect on the economy of $100 million or more. The changes in phone numbers, addresses, citations, etc., made by these rules should have no effect on the economy.

b. This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. Updating and correcting the information in the existing rules in 43 CFR part 4, subpart L, will save citizens, individual industries, and government agencies resources that would have been wasted utilizing the outdated information, e.g. , phone numbers and addresses.

c. This rule does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. The housekeeping changes in these rules will have no effects, adverse or beneficial, on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

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

a. This rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. Small governments rarely request hearings or appeals under the Surface Mining Act, and these rules would neither uniquely nor significantly affect them because these rules only bring existing rules up to date by correcting addresses, phone numbers, etc. A statement containing the information required by the Unfunded Mandates Reform Act, 2 U.S.C. 1531 et seq. , is not required.

b. This rule does not produce an unfunded Federal mandate of $100 million or more on State, local, or tribal governments or the private sector in any year, i.e. , it is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

In accordance with Executive Order 12630, the rule does not have significant takings implications. A takings implication assessment is not required. These amendments to procedural rules have no effect on property rights.

In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The only potential effect on states would be that “primacy” states, i.e. , those approximately two dozen states with approved state programs under the Surface Mining Act, may have to amend some of their procedural regulations to correspond to the changes made in these rules, and those amendments would not be significant. A Federalism Assessment is not required.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and does not meet the requirements of sections 3(a) and 3(b)(2) of the Order. These rules, because they bring up to date rules about jurisdiction, agency addresses and phone numbers, and the language and citation of rules, will relieve, not burden, both administrative and judicial tribunals.

This regulation does not require an information collection from 10 or more parties, and a submission under the Paperwork Reduction Act is not required. An OMB form 83-I has not been prepared and has not been approved by the Office of Policy Analysis. These rules provide the public with updated information concerning hearings and appeals under the Surface Mining Act; they do not require the public to provide information.

The Department has analyzed this rule in accordance with the criteria of the National Environmental Policy Act of 1969 (NEPA) and 516 DM. This rule does not constitute a major Federal action significantly affecting the quality of the human environment. An environmental impact assessment or environmental impact statement under NEPA is not required. Because of the strictly organizational and procedural contents of this rule, it is categorically excluded from NEPA review under 516 DM.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), E.O. 13175, and 512 DM 2, the Department of the Interior has evaluated potential effects of these rules on Federally recognized Indian tribes and has determined that there are no potential effects. These rules do not affect Indian trust resources; they provide updated information about procedures for hearings and appeals of decisions of the Office of Surface Mining under the Surface Mining Act.

In accordance with Executive Order 13211, this regulation does not have a significant effect on the nation's energy supply, distribution, or use. The changes of address, telephone numbers, and cross-references to other regulations are simply updating of information and will not affect energy supply or consumption.

The Department has determined that this rule should be effective immediately because it updates the Code of Federal Regulations to include accurate information. Delaying the effective date by 30 days as required by 5 U.S.C. 553(d) would mean that parties to appeals would not have correct information, resulting in delays and inconvenience. A delayed effective date would also mean that the revisions in this rule would not appear in the soon-to-be published annual revision of title 43 of the Code of Federal Regulations. This would mean that for the next year anyone consulting title 43 Part 4 Subpart L would receive inaccurate information about filing appeals. For these reasons, good cause exists for making this rule effective immediately upon publication under 5 U.S.C. 553(d)(3).

The Department has determined that the public notice and comment provisions of the Administrative Procedure Act, 5 U.S.C. 553(b), do not apply to this rulemaking because the changes made relate solely to matters of agency organization, procedure, and practice. These rules are procedural, not substantive, and they only change addresses, phone numbers, cross references to other rules, and language to conform to language in other rules. They therefore satisfy the exemption from notice and comment rulemaking in 5 U.S.C. 553(b)(A).

Throughout the preamble and the rule the terms “we”, “our” and “us” refer to FEMA.

On February 26, 2002, FEMA published an interim final rule implementing Section 322 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act or the Act), 42 U.S.C. 5165, enacted under § 104 of the Disaster Mitigation Act of 2000, (DMA 2000) Pub. L. 106-390. This identified the requirements for State and local mitigation plans necessary for FEMA assistance. The critical portion of the current interim final rule being published extends the date that the planning requirements take effect. The date is being modified from November 1, 2003 to November 1, 2004 for all programs except the Pre-Disaster Mitigation (PDM) program.

The date that local mitigation plans will be required for the PDM program as a condition of “brick and mortar” project grant funding will continue to be November 1, 2003. Our objective is to encourage the use of the PDM program to develop State and local mitigation plans that will meet the criteria for all of our mitigation programs. The initial implementation of the PDM program allows States to prioritize the funding towards the development of mitigation plans in their most high-risk communities, positioning them to be eligible for project grant funding when it becomes available. The PDM program will benefit from the experiences in the Flood Mitigation Assistance (FMA) program, which has had a planning requirement for many years. States often prioritize FMA planning funds to a community in one year, with the implementation of the project occurring after the appropriate planning has been completed.

We received many thoughtful comments on much of the rule, and we intend to address them all prior to finalizing the rule. However, the overwhelming number of comments regarding the effective date for the new planning requirements on both the State and local governments indicated to us a need to extend that date. This new interim final rule will address this issue, and clarify the planning requirement for the recently published Fire Management Assistance Grant Program final rule.

Since publication of the interim final rule, it became clear to us that, in some cases, there was a need to extend the effective date of the planning requirement to allow more time for plan development. An additional year will allow State, tribal, and local governments time to identify necessary resources, establish support for the planning process, and develop meaningful mitigation plans. Legislative sessions, which in some cases may be once every two years, may be necessary to obtain funding for plan development and/or adoption of the plan prior to submittal to FEMA. Many State and local fiscal years run from July through June, and budget requests must be made months prior to the beginning of the fiscal year. This has made it difficult for many jurisdictions to begin the planning process. Our intention in extending the date is to allow for more thoughtful and comprehensive development of plans and implementation of this regulation. Nearly all of those commenting on the rule recognize the importance of planning. The generally accepted model is that good mitigation happens when good mitigation plans are the basis for the actions taken.

Even though we are extending the date for meeting the planning requirements, we encourage States and localities to continue to work on getting plans developed and approved as soon as feasible, and not to wait until the deadline to begin the process. It is important to note that although there is no deadline for approval of Enhanced State Mitigation Plans in order to qualify for the 20 percent HMPG funding, it will only be available to States if the plan is approved prior to a disaster declaration.

Although many comments addressed the need to extend the deadline, only a few provided specific alternative dates. We received several comments requesting a phased approach to the deadline for communities based on general risk levels or the priorities identified in a State plan. At this point, FEMA is not considering any option for a phased approach to the timeline since we believe that it would make this requirement too difficult to administer, for both States and FEMA. We believe that the one-year extension for the HMGP will address most of the concerns regarding the effective date of the planning requirements.

We have also received some questions regarding the relationship of the planning requirements of the Fire Management Assistance Grant Program to the plans developed under 44 CFR part 201. A Standard or Enhanced State Mitigation plan, which includes an evaluation of wildfire risk and mitigation, as identified in 44 CFR part 201 will meet the planning requirement of the Fire Management Assistance Grant Program. Until States develop and have either of those plans approved by FEMA, States must comply with the fire management planning requirement as stated in 44 CFR part 204 by ensuring that there is a fire component to the existing State Mitigation Plan or a separate wildfire mitigation plan.

Finally, we would like to clarify that for grants awarded under any hazard mitigation program prior to October 30, 2000 for the purpose of developing or updating a hazard mitigation plan, we will not provide an increase in funding or extensions for changes in the scope of work for purposes of meeting the enhanced state plan criteria, since the enhanced plan concept did not exist prior to the Disaster Mitigation Act of 2000, enacted on that date.

We encourage comments on this interim final rule, and we will make every effort to involve all interested parties, including those who commented on the original interim final planning rule, prior to the development of the Final Rule.

In general, FEMA publishes a rule for public comment before issuing a final rule, under the Administrative Procedure Act, 5 U.S.C. 533 and 44 CFR 1.12. The Administrative Procedure Act, however, provides an exception from that general rule where the agency for good cause finds the procedures for comment and response contrary to public interest.

This interim final rule extends the date that State, tribal, and local governments have to develop mitigation plans required as a condition of FEMA grant assistance. State, tribal, and local governments are currently under the assumption that plans are required by November 1, 2003, whereas this interim final rule extends that date to November 1, 2004 for the HMGP. It does not affect the date for compliance for other programs, such as the Pre-disaster Mitigation (PDM) program. In order for State, local and tribal resources to be appropriately identified and used, it is essential that the date extension be made effective as soon as possible. We believe it is contrary to the public interest to delay the benefits of this rule. In accordance with the Administrative Procedure Act, 5 U.S.C. 553(d)(3), we find that there is good cause for the interim final rule to take effect immediately upon publication in the Federal Register in order to meet the needs of States and communities by identifying the new effective date for planning requirement under 44 CFR part 201. Therefore, we find that prior notice and comment on this rule would not further the public interest. We actively encourage and solicit comments on this interim final rule from interested parties, and we will consider them as well as those submitted on the original interim final planning rule in preparing the final rule. For these reasons, we believe we have good cause to publish an interim final rule.

44 CFR 10.8(d)(2)(ii) excludes this rule from the preparation of an environmental assessment or environmental impact statement, where the rule relates to actions that qualify for categorical exclusion under 44 CFR 10.8(d)(2)(iii), such as the development of plans under this section.

We have prepared and reviewed this rule under the provisions of E.O. 12866, Regulatory Planning and Review. Under Executive Order 12866, 58 FR 51735, October 4, 1993, a significant regulatory action is subject to review by The Office of Management and Budget (OMB) and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may:

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

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

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

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

The purpose of this rule is to extend the date by which State and local governments have to prepare or update their plans to meet the criteria identified in 44 CFR part 201. The original date, November 1, 2003, was determined to be difficult to meet. This interim final rule extends that date to November 1, 2004 for the post disaster Hazard Mitigation Grant Program. The date of November 1, 2003 will still apply to project grants under the Pre-disaster Mitigation program. As such, the rule itself will not have an effect on the economy of more than $100,000,000.

Therefore, this rule is not a significant regulatory action and is not an economically significant rule under Executive Order 12866. OMB has not reviewed this rule under Executive Order 12866.

Under Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994, we incorporate environmental justice into our policies and programs. The Executive Order requires each Federal agency to conduct its programs, policies, and activities that substantially affect human health or the environment, in a manner that ensures that those programs, policies, and activities do not have the effect of excluding persons from participation in our programs, denying persons the benefits of our programs, or subjecting persons to discrimination because of their race, color, or national origin.

No action that we can anticipate under the final rule will have a disproportionately high or adverse human health and environmental effect on any segment of the population. This rule extends the date for development or update of State and local mitigation plans in compliance with 44 CFR part 201. Accordingly, the requirements of Executive Order 12898 do not apply to this interim final rule.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) we submitted a request for review and approval of a new collection of information when the initial interim final rule was published on February 26, 2002. OMB approved this collection of information for use through August 31, 2002, under the emergency processing procedures in OMB regulation 5 CFR 1320.1, OMB Number 3067-0297. There have been no changes to the collection of information, and we have submitted a request for OMB approval to continue the use of the collection of information for a term of three years. The request is being processed under OMB's normal clearance procedures in accordance with provisions of OMB regulation 5 CFR 1320.11.

This new interim final rule simply extends the date by which States and communities have to comply with the planning requirements, and clarifies which FEMA programs are affected by these requirements. The changes do not affect the collection of information; therefore, no change to the request for the collection of information is necessary. In summary, this interim final rule complies with the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)).

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-130, adopted September 18, 2002, and released September 24, 2002. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., CY-B402, Washington, DC 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com.

FAR 33.103 and 33.104 address protests to the agency and the General Accounting Office (GAO), respectively. Both FAR sections allow an agency to establish an approval authority for awarding a contract when a protest is received prior to contract award and for continuing contract performance when a protest is received after award. NFS 1833.104(b)(1) and (c)(2) already specify that the Assistant Administrator for Procurement is the approval authority for those actions when a protest is filed with GAO, but no authority is specified relative to agency protests. To ensure the same degree of review and approval regardless of the forum where the protest is filed, this change to the NFS establishes the Assistant Administrator for Procurement as the approval authority for contract award and continuing contract performance for agency protests.

This final rule does not constitute a significant revision within the meaning of FAR 1.501 and Public Law 98-577, and publication for public comment is not required. However, NASA will consider comments from small entities concerning the affected NFS Parts 1833 and 1852 in accordance with 5 U.S.C. 610.

The Paperwork Reduction Act does not apply because the changes do not impose recordkeeping or information collection requirements which require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

NASA recently made several changes to the NFS to address safety and risk based acquisition management (RBAM) in the acquisition planning processes for negotiated procurements. This final rule makes corresponding changes to the proposal preparation processes for NASA's broad agency announcements (BAA). Two types of BAAs used by NASA include the Announcement of Opportunity (AO) and the NASA Research Announcement (NRA). This final rule amends the NASA FAR Supplement (NFS) to require, when relevant, consideration of safety and risk-based acquisition management in NASA's broad agency announcements. This change allows NASA to consider safety and RBAM as part of the proposal selection done under NASA's broad agency announcements. This change will ensure consistency in the way safety and RBAM are treated in all NASA acquisitions.

NASA published a proposed rule in the Federal Register at 66 FR 45955 on August 31, 2001. NASA received one comment on the proposed rule. The commenter suggested that risk analysis should not be imposed at early stages of research solely for consistency when it is unlikely there will be any identifiable risk that could benefit from a premature risk analysis. The commenter further recommended that NASA not require RBAM on BAAs unless the statement of work involved procurement, development, manufacture, and operation of hardware and equipment.

NASA included the phrase “where they are relevant” in its proposed rule because it agrees that in some cases the proposed work in response to a BAA may be so early in the development cycle that identification and discussion of risk factors may not be possible. However, NASA disagrees with the suggestion that risk factor identification and discussion occur only when the statement of work involves procurement, development, manufacture, and operation of hardware and equipment.

To ensure that the identification and discussion of risk factors is conducted when appropriate, NASA's proposed rule required the identification and discussion of risk factors and issues throughout the proposal “where they are relevant.”

Relevancy of risk should be easily determinable, even during the initial BAA process. For example, research involving flight hardware, hazardous material, or potentially dangerous operations includes identifiable risks. In other cases, it may indeed be too early in the research process to identify and discuss risk factors, so such a discussion would not be relevant.

Moreover, BAAs include information that will help a proposer in determining whether an identification and discussion of risks may be relevant. For instance, AO's include, as applicable, safety, reliability, and quality assurance provisions. NRAs contain programmatic information and certain requirements and will generally specify topics for which additional information or greater detail is desirable. NASA is ensuring that areas that may involve potential risk are highlighted in AOs and NRAs by requiring the participation of the appropriate NASA Safety Offices in the NRA and AO (by this rule) processes.

It is anticipated and understood that the identification of risk factors where relevant will be consistent with the level of information available at the time of the proposal. Therefore, no change is being made as a result of comments received. Minor grammatical changes have been made to NFS section 1872.307.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small business entities under the Regulatory Flexibility Act (5 U.S.C. 601, et seq. ) because it does not impose new requirements. Rather, it focuses attention on safety and risk management.

The Paperwork Reduction Act does not apply because the changes to the NFS do not impose any record keeping or information collection requirements, or collections of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

When the Department originally published its alcohol testing rules on February 15, 1994 (54 FR 7302 et seq. ), the Department established breath testing using evidential breath testing devices (EBTs) as the method to be used. However, in response to comments requesting additional flexibility in testing methods the Department said that NHTSA would develop model specifications, evaluate additional screening devices, and periodically publish a conforming products list of those additional screening devices that meet model specifications. The Department noted, too, that the Department would also have to undertake separate rulemaking proceedings to establish procedures for use by DOT-regulated industries of any devices after they are approved by NHTSA.

On April 20, 1995 (FR Vol. 60, No. 76), the Department published procedures for use of ASDs, both breath devices and saliva devices. At that time, the Department did not anticipate that additional devices would be developed that, while using breath or saliva as the means of obtaining a result, would necessitate new procedures for their use. As a result, the revised Part 40 (65 FR 79462) published December 19, 2000 stated, in part, that ASDs on the NHTSA conforming products list (CPL) could be used for Part 40 alcohol screening tests. Because NHTSA added an ASD to their CPL and the Department had no procedures for its use, we were forced to amend that rule. On August 9, 2001 (65 FR 41944) Part 40 was amended to read, “You may use an ASD that is on the NHTSA CPL for DOT alcohol tests only if there are instructions for its use in this part.”

This effectively prevented use of this ASD for DOT testing purposes even though it was on NHTSA's CPL. The Department has taken steps to rectify this situation by developing procedures for this ASD's use and by amending the regulation accordingly. We have also taken the step to fine-tune the regulation to include in regulation text the fact that breath alcohol technicians (BAT), knowledgeable of how to use an ASD (or ASDs), can conduct screening tests using them.

Instructions for use of the breath tube are somewhat parallel to those for the saliva device. Both devices prohibit use of the device after the expiration date has been reached. Both have procedures for conducting additional tests if proper procedures cannot be followed. Both have some similar fatal flaw criteria.

The breath tube requires the STT or BAT to remove a tube from the box and break the device's ampule in the presence of the employee. The STT or BAT must then attach an inflation bag to the appropriate end of the tube. The employee is given the opportunity to hold the tube and provided instructions regarding how to blow ( i.e. , forcefully and steadily for approximately 12 seconds) through the tube.

The rules also provide instructions for reading the results. In this case, the STT or BAT must compare the color of the crystals in the breath tube with the colored crystals on manufacturer-produced control tube. Comparisons must take place within specific time frames.

Fatal Flaws” require tests to be cancelled. Problems with the breath tube which cause fatal flaws are: The STT or BAT reads the device either sooner or after than the time allotted; and the device is used after its expiration date.

The breath tube works this way. When a person's breath is blown though the tube it goes around and across the tube's crystals. If the person's breath contains no alcohol, the crystals remain their original color. However, if the person's breath contains alcohol, the alcohol causes a chemical reaction leading to a change in crystal color. A color change matching the color of crystals in the control tube is indicative of a screening test result that must subsequently be confirmed using an EBT. Such a color change indicates that the screening test result is 0.02 or above.

This rule is not a significant rule for purposes of Executive Order 12866 and DOT. It does not increase costs on regulated parties. In fact it may facilitate the use of a device that may increase flexibility, and decrease costs, for employers who choose to use them. There are not sufficient Federalism implications to warrant the preparation of a Federalism Assessment. The Department certifies that this rule will not have a significant economic impact on a substantial number of small entities. To the extent that there is any such impact, it is expected to be a small favorable impact, since some small entities may be able to conduct screening tests at a lower cost.

The Department is issuing this as a final rule without opportunity for notice and public comment. The Department determined that doing so would be impracticable, unnecessary, and contrary to the public interest because this breath device already appears on NHTSA's CPL and has, therefore, proven to be an accurate screening device for Part 40 alcohol screening tests.

The National Highway Traffic Safety Administration (NHTSA) has been mandated by Congress to consider whether to prescribe clearer and simpler labels and instructions for child restraints (Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act, November 1, 2000, Pub. L. 106-414, 114 Stat. 1800). Section 14 of the TREAD Act directed NHTSA to initiate a rulemaking for the purpose of improving the safety of child restraints by November 1, 2001, and to complete it by issuing a final rule or taking other action by November 1, 2002.

On November 2, 2001 (66 FR 55623), NHTSA published a notice of proposed rulemaking (NPRM) proposing changes to the format, location, and content of some of the existing labeling requirements of the Federal motor vehicle safety standard for child restraint systems (49 CFR 571.213). Specifically, NHTSA proposed (1) a requirement that some information be molded into or heat embossed to the shell to improve durability, (2) changes to existing location requirements for some labels, (3) a uniform font specified for all labels on all child restraints, (4) a requirement that most labels be white with black text, and (5) color-coding of installation information to distinguish forward-facing from rear-facing information. In addition, with regard to content, NHTSA proposed (6) a reworded warning statement, (7) a requirement that all mandated statements related to use be arranged below that statement in a bulleted form, (8) rewording of some of these statements to simplify their language, and (9) a new diagram showing the child restraint using a new child restraint anchorage system (see 49 CFR 571.213). With regard to written instructions, NHTSA proposed (10) conforming changes with those proposed for labels and (11) a new requirement for information to assist owners in determining the meaning of the term “snugly” used on child restraint labels. Last, NHTSA proposed (12) a new labeling requirement for harness slots.

After reviewing the comments received in response to the NPRM, and research conducted subsequent to the NPRM by Transport Canada, this final rule amends the current requirements for child restraint labels and the written instructions that accompany child restraints. Specifically, the agency is changing the existing location requirements for some labels (number 2 above), requiring most labels to be white with black text (number 4 above), rewording some label statements to simplify their language (number 8 above), requiring mandated statements on labels to be in a bulleted list headed by the statement “WARNING! DEATH or SERIOUS INJURY can occur” (number 6 and 7 above), requiring a new diagram showing the child restraint using the new child restraint anchorage system (number 9 above), and requiring some additional information defining the term “snugly” to be in the written instructions (number 11 above). The other changes proposed by the NPRM have not been adopted by this final rule.

Federal Motor Vehicle Safety Standard (FMVSS) No. 213 (49 CFR 571.213) requires that all currently manufactured add-on child restraint systems  1 must be labeled with the following information (S5.5.2): the model name or number, the manufacturer's (or distributor's) name, the statement “manufactured in ( month, year ),” the place of manufacture (or location of the distributor's principal office), a certification statement, a statement concerning the manufacturer's recommendations for maximum mass and height of children who should use the child restraint, a warning statement concerning the consequences of failing to follow the instructions, statements about proper use of belts or other restraints as appropriate, an air bag warning label if the child restraint can be used rear-facing, an installation diagram, a registration statement for recalls, and a statement about use in motor vehicles and/or aircraft as appropriate. 2 This information must be in English, lettered not smaller than 10 point type, and on contrasting background, except the air bag warning label has very specific requirements for location and size. 3 The warning statement to follow the instructions, the statements about proper use of belts and other restraints, and the air bag warning must also be visible when the restraint is installed in a vehicle.

Each add-on child restraint system must have printed installation instructions (an owner's manual) that includes a step-by-step procedure, including diagrams, for installing the system in motor vehicles, securing the system in the vehicles, positioning a child in the system, and adjusting the system to fit the child (S5.6). The installation instructions must include information on attaching the child restraint to a tether anchorage or a child restraint anchorage system  4 if appropriate. The owner's manual must also include a statement that children are safer in rear seating positions; information about the types of vehicles, seats and seat belts with which the restraint can or cannot be used; a statement about the consequences of not following the warnings; a statement that the restraint should be secured in the vehicle even when not occupied, an air bag warning statement, and a registration statement for recalls. There are also some specific statements about proper use required for various types of restraints. Finally, the child restraint must have a location on the restraint for storing the owner's manual.

NHTSA received 14 comments on the proposal, from child restraint and automobile manufacturers, child restraint and automobile trade groups, and child safety consumer groups. In general, commenters were supportive of efforts to improve labels, and felt that overall the proposal would make existing labels simpler and easier to read. However, there were a number of comments about specific aspects of the proposal that will be discussed in the remainder of this notice.

The Alliance of Automobile Manufacturers objected to any changes in label and instruction requirements for built-in child restraints (other than simpler required wording and a bullet format). They asserted that requirements for built-ins would be unnecessary and burdensome without any safety benefit. The only additional changes to the requirements for built-in child restraints being adopted in this rule are black text on white background and the definition of “snugly.” For required information, a requirement for black text on a white background is just as effective at improving readability of built-in restraint labels as it is for add-on restraint labels. In addition, NHTSA is not aware of any information that there is less risk from improperly adjusting the straps on a built-in child restraint as there is on a add-on child restraint. Therefore, where built-in child restraints have the same current requirements as add-on child restraints parallel changes have been adopted.

Subsequent to the publication of the NPRM, Transport Canada conducted research on child restraint labels. The report for this research will be placed in the docket for this notice as soon as it is available. As part of that research, participants were asked to install a child restraint into a vehicle and then to install and secure a 6-month infant dummy and a 18-month child dummy. The order of the dummies was randomized. The child restraint was equipped with one of four label configurations. These configurations were:

(1) No labels,

(2) Existing manufacturer labels,

(3) Labels based on NHTSA's proposed changes to FMVSS 213, and

(4) Labels developed by Transport Canada based on a review of the human factors literature and an analysis of the tasks necessary to operate the seat chosen for the study.

After reviewing the Transport Canada study, NHTSA has concerns about some aspects of our proposal. Specifically, the study raised concerns about font, color-coding and harness slot labeling. Based on their review of the literature, Transport Canada concluded sans serif fonts were more readable, the opposite of NHTSA's research. Transport Canada's research shows that child restraints with color-coded instructions were oriented forward- or rear-facing correctly more often than child restraints without labels or with existing labels, but were still oriented incorrectly at least half of the time. The child restraint used in the Transport Canada study had an adjustable harness, rather than separate harness slots and therefore NHTSA's proposal was inappropriate for the design. Because of these findings, NHTSA believes that it would be advisable to conduct further research and then to repropose those issues in another rulemaking.

In discussing Transport Canada's research with us, Transport Canada has indicated that other research they are conducting on a performance requirement for label permanence is also promising and they expect to be able to propose a performance requirement when they begin their rulemaking. NHTSA would like to be able to review this research before making a final decision on the permanence and therefore will also repropose that issue in another rulemaking.

Therefore, this final rule will only address the following issues from the NPRM: location, background color, capital letters, height and weight statement, warning regarding the consequences of not following instructions, belt use statement, installation diagram, and voluntary labels. NHTSA plans to work with Transport Canada on a future proposal regarding further changes to the labels. NHTSA will consider any comments on those issues when it is developing that proposal.

The following sections discuss new format requirements for mandatory labels.

NHTSA currently requires the warning statement about failure to follow the instructions, the statements about proper use of belts and other restraints, and the air bag warning to be visible when the restraint is installed in a vehicle. Location is not specified for other mandatory information. NHTSA proposed that all required information, other than model name or number, manufacturer name, manufacturing date, and place of manufacture, be labeled on the child restraint so that it is visible when the restraint is installed in a motor vehicle. This would have been a change for the requirements for the certification statement, height and weight labeling, the installation diagram, the registration statement, and the statement about use in motor vehicles and/or aircraft, which are not currently required to be visible by FMVSS No. 213.

Commenters sought clarification as to what the agency meant by “visible.” For example, must the label be visible from both sides of the vehicle? NHTSA did not intend to change what is currently meant by “visible” in S5.5.3, only to broaden the list of labels that needed to meet this requirement. The specified information must be visible from either side when the child restraint is installed as specified on the standard bench seat.

Commenters also argued that only information regarding installation and securing the child needed to be visible when the child restraint was installed in a vehicle. After reviewing the comments, NHTSA agrees that only information related to installation and securing the child needs to be visible once the restraint is installed. NHTSA's purpose in proposing changes to the existing requirements is to reduce misuse of child restraints. The certification statement and registration statements are not related to proper use and therefore would not decrease misuse by being visible. The statement about use in aircraft is used when boarding aircraft, not when the seat is installed in a vehicle. Therefore, the language of this section has been modified so that only the statement regarding height and weight and the installation diagrams have been added to the visibility requirement.

NHTSA currently requires the information to be labeled “on a contrasting background.” NHTSA proposed to require all information to be in black text on a white background, except for the heading of the warnings which would be in black text on a yellow background.

Many commenters objected to this proposal, either because they felt that the current requirement for a contrasting background was sufficient, or because they felt that “white” was not specific enough to be enforceable. The Juvenile Products Manufacturers Association (JPMA) asked NHTSA to allow dark blue text to reduce costs.

As discussed in the NPRM, experience with existing labels shows that the current requirements are not sufficient. NHTSA is also not convinced that the use of the term “white” will cause problems. NHTSA has had a similar requirement for air bag labels for over five years and vehicle manufacturers have not had problems complying with the requirement for “white.” NHTSA believes that JPMA's comment was related to the proposal to color-code rear-facing information with blue. Because that proposal is not adopted by the final rule the cost issue should be moot. For these reasons, NHTSA is adopting the proposed requirement.

NHTSA proposed to delete the current requirement for block letters, and proposed that capital letters only be required in the heading for the warnings.

Commenters generally supported these proposals, but asked that the capitalization in the heading be changed to be consistent with the capitalization in the air bag warning label. This suggestion has been adopted in the final rule.

To clarify the capitalization requirements, NHTSA is amending S5.5.2(h) through (j), S5.5.5(h) and (i), and S5.6.1.10 so that the regulation is not written in all capitals. NHTSA has interpreted the requirements so that capital letters were not required. However, this change will clarify that normal sentence capitalization shall be used in labels and instructions, unless Standard No. 213 shows a word as all capital letters.

In the following subsections, NHTSA discusses changes and additions to mandated language for child restraint labels.

NHTSA proposed minor changes to simplify the language in the required statement regarding height and weight, so that it would read, “Use only with children * * *” NHTSA asked for comments on deleting the height references in these statements to further simplify them.

While only one commenter explicitly supported the simplified language, no commenter objected to it. Therefore, NHTSA is adopting the simplified language in this final rule.

With regard to deleting the height reference, only one commenter disagreed. Other commenters that supported deleting this reference noted that the important measures are seated height, which parents don't generally know, or the relative position of the child's head to the child restraint. One commenter suggested that the agency require a label with functional wording such as, “This child seat should not be used rear-facing if the top of the child's head is above the red line.” (see comment of National SAFE KIDS Campaign, NHTSA-2001-10916-14)

Despite the widespread support for deleting the reference to standing height, NHTSA is not doing so at this time. None of the commenters suggested that height was irrelevant to proper use, only that there may be better ways to convey this information. NHTSA plans to explore requirements for more functional wording, such as that suggested in these comments, in future research. In the interim, NHTSA believes that while standing height may not be a perfect indicator of proper fit, it is better than no information.

NHTSA has also added an option for seats that can only be used as belt-positioning seats to be labeled only with the maximum height the seat can be used for. NHTSA believes that by allowing manufacturers the option of labeling these seats only with the maximum height for which they can be used, we will more clearly convey the appropriate information to parents and caregivers. This will also allow manufacturers of these seats to label them consistent with NHTSA's policy that children who have outgrown child safety seats should use a booster seat until they are at least 8 years old, unless they are 4'9” tall, regardless of weight.

NHTSA proposed to replace the current statement about the consequences of not following the instructions on child restraints with the following statement:

• Follow all instructions on this child restraint and in the written instructions located_____

This would be followed with additional bullets for any additional mandated statements, including the statement about maximum height and weight, and the statements about use of belts or other restraints. As discussed earlier, NHTSA also proposed to require the heading to be in black text on a yellow background and requested comments on whether it should require or allow the alert symbol used on the air bag warning label (see Figure 10 in FMVSS No. 213).

Generally commenters supported this proposal and the use of the alert symbol, but had some questions and suggestions. One commenter asked that only the alert symbol and the word “warning” be on a yellow background, consistent with the vehicle air bag warning label on the sun visor. One commenter objected to the proposed label, speculating that the proposed heading might lead parents to believe that the child restraint itself is a source of potential harm.

Because of the universal support for the alert symbol, NHTSA is requiring it in this final rule. NHTSA is not removing the phrase “death or serious injury can occur” from the heading. The commenter offered no evidence that this phrase would discourage child restraint use. NHTSA's research for other labels indicates that this statement is more likely to get the user's attention and cause them to read the warnings that follow than the word “warning” alone. This is particularly true for parents that are being provided information related to their children. However, NHTSA will explore this phrase in future research to ensure that it is not interpreted differently in this context. Because of the similarity between the new heading required for child restraint label warnings and the air bag warning label in vehicles, NHTSA is allowing manufacturers the option of having the phrase “death or serious injury can occur” on either a yellow or white background.

The Alliance of Automobile Manufacturers requested a minor change to the first bullet for built-in child restraints to read, “Follow all instructions on this child restraint and in the vehicle's owner's manual.” NHTSA agrees that this is simpler than language that would have been likely under the proposal (* * * in the written instructions located in the vehicle's owner's manual). Therefore, the requirements for built-in child restraints are modified to reflect this comment.

Graco, a child restraint manufacturer, asked if the label had to be one label or could be multiple labels as long as they were applied in the correct order. NHTSA is not requiring that the mandated warnings be on a single label, so long as the separate components are attached to the child restraint in the correct order and without any intervening labels.

Because of concerns about the vagueness of the term “snugly,” NHTSA proposed requiring the following information to be included in the written instructions. This information is used in NHTSA's Standardized Child Passenger Safety Training Curriculum.

Commenters did not strongly support this proposal, noting that the proposed language is fairly complicated. Some commenters suggested requiring a picture, though no specific pictures were suggested. One commenter noted that the information is not needed on self-adjusting harnesses.

NHTSA is not aware of a commonly used picture that could be used to illustrate how snugly to adjust a harness. Since further research will be required on other issues in light of the Transport Canada study, NHTSA could also develop and test one or more illustrations that could be required. In the interim, NHTSA is requiring a modified statement be included in the written instructions. In reviewing the comments NHTSA noted that the second half of the first statement was duplicated in the second statement.

The new statement is:

NHTSA is also modifying the language of the regulation requiring the “snugly” statement on child restraints and the explanatory statement in the written instructions to exclude belts that automatically adjust to fit the child.

NHTSA proposed to require an additional installation diagram showing the child restraint installed in a seating position with a child restraint anchorage system, and requested comments on whether the current requirement for a diagram showing the child restraint installed in a seating position equipped with a lap belt can be deleted.

Commenters uniformly support requiring a diagram showing a child restraint installed in a seating position with a child restraint anchorage system, and this proposal has been adopted.

Commenters were mixed in their opinions about whether NHTSA should delete the diagram of a child restraint installed in a seating position equipped with a lap belt. Commenters who disagreed with deleting this diagram noted that there are still a number of vehicles in use that have lap belts only at one or more seating positions. Ford stated that NHTSA should delete this requirement because in some vehicles the only position with a lap belt only is the center front position and some users may interpret this diagram to require them to install a rear-facing child restraint in this position.

With regard to the Ford comment, child restraints are required to have three different diagrams—lap belt only, lap/shoulder belt and a child restraint anchorage system. In addition there are numerous warnings against putting a rear-facing child restraint in the front seat of a vehicle with an air bag. Thus NHTSA believes there is sufficient contradictory information to prevent the interpretation Ford suggests.

In addition, NHTSA notes that in addition to all the vehicles currently in use with seating positions that have only a lap belt, lap/shoulder belts are also not required at all seating positions in vehicles being produced today. Therefore, there will be many instances where a child restraint user needs to know how to install the child restraint in a seating position with only a lap belt. Accordingly, NHTSA has not deleted the requirement for the lap belt only diagram.

In the NPRM, NHTSA requested comments on whether Spanish should be required on child restraint labels. While all commenters would have supported allowing other languages, many were critical of mandating another language. Those who were against mandating Spanish language labels noted that, combined with the visibility requirement, this could limit the amount of information a manufacturer could label on a child restraint. One commenter suggested requiring a statement both labeled on the child restraint and in the written instructions directing the user to the availability of Spanish language instructions unless a manufacturer voluntarily used Spanish language labels and instructions.

While NHTSA encourages manufacturers to provide Spanish language labels and instructions, or labels and instructions in other languages if warranted by the target sales population, NHTSA is not convinced that it should mandate that manufacturers provide labels or instructions in any additional languages. NHTSA will continue to allow additional labels in languages other than English, however language has been added to the standard to specify that information in additional languages must be an accurate translation of the required information.

NHTSA requested comment on whether voluntary labels should be required to meet the same requirements as mandatory labels. Some commenters noted that this question was vague, but assumed that it referred to the requirements regarding visibility, font and color. These were indeed the types of requirements NHTSA was referring to. Most commenters, while noting that most manufacturers would use the same font or background colors, felt that this should not be required. Some of the concerns noted were space with the visibility requirement or effect on corporate logos.

NHTSA is not requiring voluntary labels to comply with any of the requirements for mandatory labels in this rule. NHTSA is sensitive to some of the possible concerns raised by the commenters and has decided that its current position that voluntary information is permitted as long as it does not distract from mandatory information is sufficient. However, to reinforce this NHTSA has added language to the standard that voluntary labels cannot distract from mandatory information. Such distraction could be caused by color, size, font or other visual attributes, not just content.

In the NPRM, NHTSA requested comment on mandating a minimum reading level for labels and written instructions in lieu of mandating specific language. One of the commenters on the NPRM, Uniformed Services University of the Health Sciences, stated that they had conducted readability tests on written instructions and found that they required a 10th grade reading level on average. NHTSA will reconsider mandating a minimum reading level for labels and written instructions after conducting more research.

NHTSA also asked for comments on the availability of on-line registration. Commenters supported this idea, as long as mail-in registration cards were still available for those who do not have access to the internet. In the next rulemaking NHTSA will propose changes to the registration card to make it easier for manufacturers to inform child restraint purchasers of such an option.

Commenters also raised issues not addressed in the NPRM. The Alliance of Automobile Manufacturers asked NHTSA to specify that metric measurements be listed first in the height and weight statements to harmonize with Canadian requirements. Because metric measurements are not the most commonly used in the United States, NHTSA is not considering such a mandate. However a 1996 interpretation letter to General Motors has stated that manufacturers have this option if they chose. Ford stated that there were still statements that were not in plain English. One suggested change regarding the statements about placing certain child restraints in a rear-facing position has been made since it parallels the proposed changes for the height/weight statements. Other suggestions will be considered in the next rulemaking. Any other suggestions for issues not raised in the NPRM, such as formats for dates, will be considered prior to issuing the next proposal.

While NHTSA didn't propose a specific effective date, a couple of commenters addressed this issue. The Alliance of Automobile Manufacturers asked NHTSA to allow either the current or new requirements for several years because there is no safety need for changes for built-in child restraints. The Alliance also asked NHTSA to coordinate the effective date with rulemaking Transport Canada plans to do in the future. Evenflo, a child restraint manufacturer, asked for a one year leadtime, but noted that they could implement the proposed changes in 180 days if the molding requirement were dropped.

NHTSA is requiring all child restraints to comply with these new requirements within one year of the date of publication of this final rule. As discussed earlier, to the extent that built-in child restraints have requirements similar to add-on child restraints, there is no indication that the safety need to understand the required information is different. NHTSA cannot wait until an unspecified time in the future when Transport Canada will conduct rulemaking to coordinate effective dates because we have a statutory mandate to conduct rulemaking now. However, NHTSA hopes to coordinate the next rulemaking with Transport Canada, including effective dates. Since Evenflo indicated that it could comply within 180 days if there were no molding requirement and automobile manufacturers have complied with other labeling requirements within the same time frame, allowing a year should not impose an unreasonable burden. Manufacturers will be allowed to comply with either the existing requirements or the new requirements prior to that date.

In the NPRM, NHTSA stated that it intended to conduct further passive evaluation, 5 at a minimum, prior to issuance of a final rule to verify that the changes have reduced the reading level necessary to comprehend the labels. NHTSA has not conducted this research prior to issuing this final rule. NHTSA intends to do this and other research prior to beginning the next rulemaking on child restraint labels. While the changes made in this final rule include recommendations made during the initial passive evaluation and therefore should improve readability, NHTSA anticipates that the changes made at this stage are modest and would result in only a minor change to the reading level required to comprehend child restraint labels. Therefore, we have decided that it would be a better use of agency resources to conduct further passive evaluation as part of the research NHTSA will be conducting for the next rulemaking, which will further improve the labels and are more likely to achieve the level of reduction in reading level that the agency would ultimately like to achieve. NHTSA expects to conduct additional research within the next year and begin another rulemaking after the completion of that research.

Prior to issuing this final rule, NHTSA has discussed which issues are covered with Transport Canada to ensure that they agree that these issues are not contraindicated by their research. Prior to beginning further research, NHTSA will work with Transport Canada to coordinate our research efforts to ensure that the efforts of both agencies are consistent.

This rulemaking document was not reviewed under E.O. 12866, “Regulatory Planning and Review.” The agency has considered the impact of this rulemaking action under the Department of Transportation's regulatory policies and procedures, and has determined that it is not “significant” under them. In the “Final Economic Assessment, FMVSS No. 213, FMVSS No. 225, Child Restraint Systems, Child Restraint Anchorage Systems,” February 1999, the agency estimated that there were 68 fatalities and 874 injuries caused annually by misuse of child restraints. We are unable to estimate the effectiveness of these proposals on this target population, but by providing clearer instructions we expect to reduce misuse.

NHTSA anticipates that the cost of changing the location and text of the labels to be minor. There is a cost for adding color, estimated to be $.01 to $.03 per label.

The agency has considered the effects of this final rule under the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as amended. I hereby certify that this rule will not have a significant economic impact on a substantial number of small entities. As noted above, the agency does not anticipant any significant economic impact from this final rule.

The Department of Transportation has not submitted an information collection request to OMB for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). The affected public is 10 child restraint manufacturers and 6 vehicle manufacturers. This rule does not impose any new information collection requirements on manufacturers. NHTSA does not anticipant a significant change to the hour burden or costs associated with child restraint labels and written instructions.

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

This final rule has been analyzed in accordance with the principles and criteria set forth in Executive Order 13132 and have determined that this final rule does not have sufficient Federal implications to warrant consultation with State and local officials or the preparation of a Federalism summary impact statement. The final rule would not have any substantial impact on the States, or on the current Federal-State relationship, or on the current distribution of power and responsibilities among the various local officials.

NHTSA has analyzed this rulemaking action for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action would not have any significant impact on the quality of the human environment.

This final rule would not have any retroactive effect. Under 49 U.S.C. 21403, whenever a Federal motor vehicle safety standard is in effect, a State may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except if the state requirement imposes a higher level of performance and applies only to vehicles procured for the States' use. 49 U.S.C. 21461 sets forth a procedure for judicial review of final rules establishing, amending or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceeding before parties may file suite in court.

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) directs NHTSA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as the Society of Automotive Engineers (SAE). The NTTAA directs NHTSA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards. The NTTAA does not apply to symbols.

There are no voluntary consensus standards available at this time. However, NHTSA will consider any such standards when they become available.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million in any one year (adjusted for inflation with base year of 1995). Before promulgating a rule for which a written statement is needed, section 205 of the UMRA generally requires NHTSA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows NHTSA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the agency publishes with the final rule an explanation why that alternative was not adopted.

This final rule will not result in the expenditure of more than $100 million annually.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

The final rule listing the Preble's meadow jumping mouse ( Zapus hudsonius preblei ) (Preble's) as a threatened species under the Endangered Species Act (Act) of 1973, as amended, (16 U.S.C. 1531 et seq. ) was published in the Federal Register on May 13, 1998 (63 FR 26517). Section 9 of the Act prohibits take of endangered wildlife. The Act defines take to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect or to attempt to engage in any such conduct. However, the Act also provides for the authorization of take and exceptions to the take prohibitions. Take of listed species by non-Federal property owners can be permitted through the process set forth in section 10 of the Act. For federally funded or permitted activities, take of listed species may be allowed through the consultation process of section 7 of the Act. We, the Fish and Wildlife Service, have issued regulations (50 CFR 17.31) that generally apply to threatened wildlife the prohibitions that section 9 of the Act establishes with respect to endangered wildlife. Our regulations for threatened wildlife also provide that a “special rule” under section 4(d) of the Act can be tailored for a particular threatened species. In that case, the general regulations for some section 9 prohibitions do not apply to that species, and the special rule contains the prohibitions, and exemptions, necessary and advisable to conserve that species.

On December 3, 1998, we proposed a section 4(d) rule (63 FR 66777) to define conditions under which certain activities that could result in incidental take of Preble's would be exempt from the section 9 take prohibitions. We held two public meetings, attended by 129 people. We also received 614 comment letters. On May 22, 2001, we published a final rule (66 FR 28125) adopting certain portions of this proposal. Some comments received on the proposed rule suggested additional exemptions to promote conservation of the Preble's. On August 30, 2001, we published a proposed rule (66 FR 45829 ) to amend the section 4(d) rule to add special provisions providing exemptions from section 9 prohibitions for certain noxious weed control and ditch maintenance activities. We are now adopting the amendment providing these additional exemptions.

In the August 30, 2001, proposed amendment and associated notifications, we asked all interested parties to submit comments on the proposed amendment. We received nine comment letters in response to the proposed amendment to the 4(d) rule. The State of Wyoming sent comments from two of their State agencies under one cover letter. One Colorado and one Wyoming county submitted comments, as did a Colorado municipality. Two letters came from water and irrigation-related organizations or companies, one letter came from a real estate interest in the development community, and two letters came from ranching/agriculture-related groups.

Most of the comment letters acknowledged the need for the proposed exemptions. Many stated that the exemptions are necessary to allow citizens and companies to comply with State laws in both Colorado and Wyoming, and to improve landowner and ditch owner cooperation in conservation of the mouse and its habitat. The comments also generally recognized that the exemptions are necessary for the long-term maintenance of the ditches and the adjacent mouse habitat that is dependent upon those ditches.

Several of the comment letters expressed general concerns or questions about the validity of the Preble's listing and its scientific foundation, questions about uncertainty in distinguishing Preble's from similar species and the need for genetic testing, and requests that the listing be withdrawn or that the Service delist the Preble's. These issues are not germane to the proposed amendment and, therefore, are not discussed here.

Written comments received during the comment period that are specific to the proposed amendment are addressed in the following summary. Comments of a similar nature are grouped under a number of general issues.

Issue 1 —Two letters expressed confusion regarding the timeframe that the proposed amendment would be in place, believing that it extended or continued beyond the 36-month timeframe of the existing 4(d) rule.

Response —The amendment should run concurrently with the existing 4(d) rule that became effective on May 22, 2001 (66 FR 45829). Therefore, this rule should expire on May 22, 2004, at the same time as the existing 4(d) rule.

Issue 2 —One commentor felt that the definition of noxious weeds is unclear and seems to apply only to plants designated on the State lists of noxious weeds as defined by Colorado and Wyoming. This letter suggests that the term “noxious” should be replaced with the term “undesirable” wherever it occurs in the rule.

Response —State statutes in both Colorado and Wyoming require noxious weeds to be controlled. The term “noxious” is legally defined in statutory requirements to mean plant species that are nonindigenous and have negative impacts on crops, livestock, native plant communities, or the management of natural or agricultural systems. The term “undesirable” is not a legally defined term relating to these statutory requirements and is not consistent with our purpose to limit the exemption to control actions for “noxious” weeds as defined by the States of Colorado and Wyoming. This amendment exempting noxious weed control should alleviate possible conflicts due to the Preble's listing with statutory requirements regarding weed control activities in the States of Colorado and Wyoming and is consistent with the conservation of the Preble's.

Issue 3 —The requirement for noxious weed control to be done pursuant to a weed management plan implemented in “consultation with the weed control officer designated by the applicable county or municipal government” will be administratively burdensome. The commentor suggests that “consultation” with local governments use a “programmatic approach.”

Response —We discovered that our proposed rule language regarding noxious weed control did not properly consider regulations within the State of Wyoming. The Colorado Noxious Weed Act requires county and municipal governments to develop a recommended integrated management plan for noxious weed control and also requires that individual landowners either implement the county or local government plan or develop their own integrated management plans for their property. The Wyoming Weed and Pest Control Act requires weed management plans to be completed by the individual weed and pest districts and requires individual landowners to control noxious weeds identified by the State list and the local jurisdiction.

To more accurately reflect these State's regulations, we have changed the language of § 17.40 (l)(2)(vi) to read as follows:

The language in the proposed rule requiring a weed management plan and consultation with the weed control officer has been deleted. We intend to exempt those noxious weed control activities that are conducted in accordance with State law. We are willing to work with county and local municipality weed management personnel or other weed management professionals familiar with local areas to develop a suitable programmatic approach with reasonable and easy-to-follow guidelines.

In the event of future revisions to EPA label restrictions and herbicide application guidelines, users shall follow these revisions to assure protection of the Preble's meadow jumping mouse.

Issue 4 —One commentor suggested that the standards for “best available methods of integrated management” be prescribed in the local weed management plan, and the required contents of such a plan should be understood and agreed to by the local governments prior to including this provision in the final rule.

Response —As addressed in the Response to Issue 3, the proposed language in section (vi) (B) referring to “best available methods of integrated management” language has been deleted from the rule. With this rule language, local governments and municipalities retain control over noxious weed management. We should exempt those noxious weed control activities that are conducted in accordance with State law.

The Colorado Noxious Weed Act requires that Integrated Pest Management techniques be used to the extent that they are the least environmentally damaging, practical, and economically reasonable means of control. Integrated Pest Management is defined as the planning and implementation of a coordinated management program using a variety of mechanical, biological, and chemical methods to control noxious weeds. Article 3 of the Wyoming Weed and Pest Control Act calls for a “Special Management Program,” which strongly emphasizes the use of integrated management and provides for financial incentives when individuals sign up under this program. In addition, the Wyoming Department of Agriculture, Wyoming Weed and Pest Council, and the University of Wyoming conduct two training sessions annually that emphasize integrated weed management techniques and the latest information in environmentally friendly methods of control.

Issue 5 —Comments included concerns regarding the amount of area in which noxious weeds can be controlled and what limitations the Service deems “appropriate.” One commentor suggested that no limitations should be considered because that would contradict State laws and Federal policy and that incomplete control would not be effective.

Response —The rule includes no limitations concerning the “amount of area” in which noxious weeds can be controlled. The only area limitations in the rule relate to ditch maintenance activities. The language in the amendment exempts noxious weed control activities that are conducted pursuant to State law and in accordance with EPA herbicide labeling. We encourage efforts to reduce the adverse effects of weed control on native plant communities and limit unnecessary eradication of entire plant communities and suggest that methods to reduce impacts to nontarget species should be employed whenever possible, such as the use of selective herbicides that target broad-leaved plants and do not damage native grasses.

Issue 6 —One comment letter requested unrestricted ditch maintenance be allowed when the ditch is located outside “naturally occurring potential Preble's habitat,” which the commentor defined as “the 100-year flood plains associated with rivers and creeks, between 7,600 feet and 4,500 feet in elevation.”

Response —This amendment provides certain exemptions from take as defined by the Act. If a ditch does not have habitat and/or mice, then no exemption is needed.

Trapping data show that many ditches have suitable habitat for Preble's and, in several areas, that Preble's exist on ditches that occur outside the 100-year floodplain. We intend to limit exemption of ditch maintenance to those activities that have minimal take of Preble's and are consistent with the protection and enhancement of Preble's habitat. As stated in the May 22, 2001, 4(d) rule, we believe it is imprudent to provide unrestricted exemption from take along ditches because in some areas: (a) Many ditches are suspected or known to be occupied by Preble's; (b) the stability of the local Preble's population is uncertain; (c) the degree of importance of ditch habitat to Preble's populations is not completely known; and, (d) some occupied ditches may serve as important population refugia and travel corridors connecting populations.

Under appropriate circumstances, permits can be obtained to carry out ditch maintenance activities even when more than minimal take is likely to occur. These activities may be addressed through future Habitat Conservation Plans or section 7 consultations.

Issue 7 —One comment letter suggested that exemption will not be sufficient and ditches will be unable to convey water. This letter requested that the exemption be changed to an “entire range-wide exemption.”

Response —As discussed above, we do not believe it would be prudent to grant a range-wide or unrestricted exemption for ditch maintenance activities. It is our intent to limit exemption of ditch maintenance to those activities that have minimal take of Preble's and are consistent with the protection and enhancement of Preble's habitat.

Issue 8 —How does the exemption apply to ditch maintenance activities that are subject to other Federal approvals?

Response —This exemption does not affect other Federal approvals required for ditch maintenance. Under section 7 of the Act, a Federal agency that undertakes, permits, or funds activities that are likely to adversely affect a listed species, whether or not take is involved, shall formally consult with the Service regarding the proposed action. Exemption from take prohibitions in section 9 of the Act does not alter responsibility of Federal agencies under section 7. This said, the number of section 7 consultations is expected to be low based on past numbers and, because of exempted actions, the amended rule should further expedite the section 7 process because subsequent consultations will consist of verifying whether the effects of the proposed action are consistent with the effects analysis conducted in establishing this regulation and documenting the determination. For actions that are consistent with this regulation, consultation will be streamlined by linking to the biological opinion prepared in conjunction with this rulemaking. For any actions not consistent with this regulation, preparation of a separate biological opinion will be necessary.

Issue 9 —Does the exemption apply to both sides of the ditch or just one?

Response —The exemption applies to both sides of the ditch. Ditch maintenance activities under the exemption should allow for the loss of 1/4 -mile of riparian shrub habitat on both banks of a ditch within any 1 linear mile of ditch within any calendar year.

However, if only one bank of a ditch is to be maintained, the 1/4 -mile loss limit still applies.

Issue 10 —The final rule should consider both physical and legal access under the requirement to “avoid shrubs if possible.”

Response —The amendment states that impacts to shrub vegetation shall be avoided “to the maximum extent practicable.” The intention of this statement is to refer to both physically practicable and legally practicable, i.e. , through legal access to the ditch.

Issue 11 —The 1/4 -mile limitation on ditch maintenance activities will result in changes to normal procedures and increased maintenance costs. Additionally, one letter expressed concern that the two additional exemptions would not benefit landowners and the economy. The commentor argued that any benefits to the landowner or economy would only be because the owners would not have to consult on every ditch-cleaning project. This commentor also stated that limits on maintenance activities of 1/4 -mile per mile of ditch are inconvenient for owners because it would take 4 years to be able to clear the entire ditch.

Response —This rule does not place any additional restrictions on land use activities and does not place any additional prohibitions on take of Preble's. Rather, this rule removes some take prohibitions that might otherwise restrict certain activities. Currently, on ditches that are occupied by Preble's, take is prohibited by section 9 of the Act without the appropriate permits. This take prohibition is removed by this amendment within the limitations given in the amendment. Therefore, this exemption is expected to decrease any current financial burden caused by the existing prohibitions. Normal ditch maintenance activities should be allowed without the time, money, and effort required to obtain incidental take permits, while still allowing for the conservation of the species. Under certain circumstances when more than minimal take is likely to occur, permits can be obtained through Habitat Conservation Plans or section 7 consultations to carry out additional maintenance activities not covered by the rule or amendments.

Issue 12 —The November to April timeframe for ditch maintenance activities is difficult in Wyoming where it may snow from September through May.

Response —This seasonal limitation for ditch maintenance activities is designed to occur while the mouse is in hibernation, in order to reduce adverse impacts and be consistent with the conservation of the Preble's. However, as stated in the amended rule in “Timing of Work”, under “Best Management Practices”, this restriction is to be observed to the “maximum extent practicable.” Otherwise, if this restriction is impracticable, exempted maintenance activities shall be conducted during daylight hours and only carried out during the Preble's active season, May through October.

Issue 13 —The proposed rule has too many “subjective” standards and does not provide “adequate notice” or understandable definitions regarding which activities are covered and which are not ( e.g. , “normal and customary,” “maximum extent practicable,” “functionally intact and viable”).

Response —The goal of this amendment is to allow agriculture and water use to continue while being consistent with conservation of the species. We did not want to define the exemptions too narrowly because there is a wide variation of how these activities might be applied on the ground. The Service recognizes the need to maintain some amount of flexibility in interpretation.

Issue 14 —One comment letter stated that the scale of agricultural operations in Wyoming makes the rule “unworkable.” The commentor believes that these exemptions may be reasonable for smaller, more intensively managed plots in Colorado, but will only result in “frustrations and resentment” in Wyoming. The commentor states that we are placing an unfair and disproportionate burden on agriculture in Wyoming when the real threats lie within the Front Range of Colorado.

Response —This rule does not place any additional restrictions on land use or any additional prohibitions on take. Current prohibitions on take through section 9 of the Act require a Federal permit for activities that are deemed to adversely affect the Preble's to the point where take may occur. Our goal in exempting noxious weed control and ditch maintenance activities through this amendment is to remove some of these take prohibitions and provide relief from current regulatory restrictions on agricultural entities and water users, regardless of location.

Issue 15 —Some respondents believed that any exemption should include maintenance of (1) water supply wells and water measurement devices, (2) dams and other infrastructure, and (3) associated roads.

Response —In regard to (1) above, an exemption applying to activities covered in § 17.40 (l)(2)(v) of the final rule relates to existing uses of water associated with the exercise of perfected water rights, so maintenance of water supply wells and water measurement devices is covered. In regard to (2), this exemption covers only maintenance and replacement of dams or infrastructure directly related to, and used in, the operation of ditches. Any person contemplating dam or infrastructure work not covered by either of these two exemptions should consult with us when the maintenance procedure has the potential to take Preble's. Finally, pertaining to (3), this amendment includes a limited exemption for maintenance of roads used to access existing ditches and related infrastructure provided that these activities do not exceed the maximum allowable loss of riparian shrub habitat in any calendar year.

The special regulations contained in this amendment are applicable until May 22, 2004, which is the end of the effective period for the May 22, 2001, final 4(d) rule. We expect that, by that date, comprehensive Habitat Conservation Plans for the Preble's should be developed, and a recovery plan and other conservation efforts for the Preble's should be completed.

The activities discussed below, which may result in incidental take of Preble's, are exempted from the section 9 take prohibitions. “Incidental take” refers to a taking that is otherwise prohibited, if such taking is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity. Take not exempted by this amendment and not otherwise authorized under the Act may be referred to the appropriate authorities for civil enforcement or criminal prosecution.

a. Noxious weed control activities —Comments on the proposed 4(d) rule of December 3, 1998, included a request to consider a rangewide exemption for control of noxious weeds. The comments stressed that laws in both Colorado and Wyoming require control of noxious weeds and that such control is compatible with Preble's conservation. We are amending the final 4(d) rule by including a rangewide exemption for noxious weed control to conform to existing State laws and Federal regulations regarding herbicide labeling. We believe that this exemption should facilitate conservation of the Preble's, because noxious weeds are displacing desirable natural vegetation on which the Preble's depends for survival.

b. Ongoing ditch maintenance activities —In the December 3, 1998, proposed 4(d) rule, we stated that we considered adopting an unrestricted exemption for periodic maintenance of existing water supply ditches, but chose not to do so because ditches support occupied and potential Preble's habitat. We received a large number of comments on this decision, many supporting an unrestricted exemption and arguing that current maintenance practices have resulted in viable habitat for the Preble's.

In response to these comments, we have elected to adopt a limited exemption for customary ditch maintenance activities that are designed to result in only minimal take of Preble's and are consistent with the protection and enhancement of Preble's habitat. This exemption builds upon the guidance provided in a January 31, 2001, “To Whom It May Concern Letter” (Letter), which we originally issued on March 11, 1999, and reissued on February 1, 2000, and January 31, 2001, and which was our initial response to these comments. While the Letter specifically describes activities throughout the range of the Preble's that we believe would not constitute take under section 9 of the Act, this amendment to the 4(d) rule specifies certain activities that may result in take and grants exemption from such take.

Our intent is to allow normal and customary maintenance activities that should result only in temporary or limited disturbance of Preble's habitat, and that should result in only minimal take of Preble's. We intend for this exemption to apply only to manmade ditches and not to alteration of habitat along naturally occurring streams and watercourses.

We believe that a limited exemption is necessary and advisable, not only to provide relief to those who shall maintain active ditches, but to assure that currently existing Preble's habitat along ditches remains functionally intact and viable. Should limited ditch maintenance not be allowed to continue, we face the possibility that these ditches would no longer be capable of conveying water and any habitat dependent on this water would degrade over time and eventually be lost. Maintenance of these ditches, as defined by this amended rule, is necessary and advisable to maintain future conservation options for the Preble's.

Therefore, we are exempting from the section 9 take prohibitions, limited maintenance activities on water conveyance ditches throughout the range of the Preble's. We believe that providing unrestricted exemption from take for all ditch maintenance activities would be imprudent because—(a) Some areas contain many ditches known or thought to be occupied by Preble's, (b) the stability of many local Preble's populations is uncertain, (c) the importance of ditch habitat to Preble's populations in many areas is not completely known, and (d) some occupied ditches may serve as important population refugia and travel corridors connecting populations.

The following ditch maintenance activities are exempted from the take prohibitions of section 9 of the Act, if the Best Management Practices described below are followed:

1. Normal and customary ditch maintenance activities that result in the annual loss of no more than 1/4 -mile of riparian shrub habitat within any 1 linear mile of ditch within any calendar year. Riparian shrub habitat is defined as vegetation dominated by plants that generally have more than one woody stem that measures less than 2 inches in diameter and are typically less than 10 feet in height at maturity, put on new growth each season, and have a bushy appearance. Examples of shrubs include, but are not limited to, willow, snowberry, wild plum, and alder.

2. Included in No. 1 above is the burning of ditches that results in the annual loss of no more than 1/4 -mile of riparian shrub habitat within any 1 linear mile of ditch within any calendar year and is conducted out-of-season (see “Best Management Practices”).

The following Best Management Practices shall be implemented in order for the exemptions to apply:

1. Persons engaged in ditch maintenance activities shall, to the maximum extent practicable, avoid impacts to shrub vegetation. For example, if it is possible to access the ditch for maintenance or repair activities from an area containing no shrubs, then damage to adjacent shrub vegetation shall be avoided.

2. Persons engaged in placing or sidecasting (a) silt and debris removed during ditch cleaning, (b) vegetation or mulch from mowing/cutting, or (c) other material from ditch maintenance shall, to the maximum extent practicable, avoid shrub habitat, and at no time disturb more than 1/4 -mile of riparian shrub habitat within any 1 linear mile of ditch within any calendar year.

3. To the maximum extent practicable, all ditch maintenance should be carried out during the Preble's hibernation season, November through April. Any maintenance activities carried out during the Preble's active season, May through October, should be conducted during daylight hours only.

This exemption includes maintenance of roads used to access ditches and related infrastructure. These maintenance activities are limited to the historic footprint associated with the infrastructure and access roads. Examples of activities that are covered by the exemption include the following activities, each limited to the destruction of 1/4-mile of riparian shrub habitat within 1 linear mile of ditch within any calendar year:

1. Clearing trash, debris, vegetation, and silt by either physical, mechanical, chemical, or burning procedures —Examples include mowing or cutting grasses and weeds, removal of silt and debris from the ditch below the high-water line, and control of shrubs that could result in ditch leakage.

2. Reconstruction, reinforcement, repair, or replacement of existing infrastructure with components of substantially similar materials and design —Examples include replacement of a damaged headgate, grading or filling areas susceptible to ditch failure, patchwork on a concrete ditch liner, or replacement of failed culvert with a new culvert of the same design and material.

The following maintenance activities are not exempted from the take provisions of section 9 of the Act:

1. Replacement of existing infrastructure with components of substantially different materials and design —such as replacing an existing gravel access road with a permanently paved road.

2. Construction of new infrastructure or the movement of existing infrastructure to new locations —Examples include redrilling a well in a new location, building a new access road, change in the location of a diversion structure or installation of new diversion works where none previously existed.

We proposed the two additional exemptions contained in this rule in the August 30, 2001, proposed amendment in response to comments received during the public review of the December 3, 1998, 4(d) rule proposal. Water rights owners argued that the lack of an exemption for periodic maintenance of existing ditches conflicted with the exemption for existing uses of perfected water rights, because ditch maintenance is an intrinsic part of exercising a perfected water right. In addition, respondents noted that ditch maintenance is required by State law in both Wyoming and Colorado. Failure to adequately maintain water conveyance structures can result in fines, penalties, and liability for damage to property caused by ditch failures. Finally, respondents noted that prohibition of ditch maintenance could subsequently result in curtailment or cessation of water diversions. This situation in turn could result in forfeiture or abandonment of water rights under State law.

By exempting limited periodic maintenance activities on existing water supply ditches, this amendment facilitates consistency among the rangewide exemptions. Where appropriate, permits can be issued under section 10 of the Act to allow incidental take of Preble's for activities not exempted through this rule.

Several respondents requested rangewide exemptions for maintenance of other types of water-related infrastructure. The suggested exemptions included: maintenance of (1) sewer lines; (2) wastewater treatment and conveyance facilities; and (3) storm water collection, conveyance, and treatment facilities.

We elected not to exempt these types of water-related infrastructure. These systems typically incorporate extensive pipeline systems that either cross Preble's habitat, or are installed along stream corridors that provide Preble's habitat. Activities to maintain this infrastructure can create large areas of surface disturbance within or near Preble's habitat that could temporarily or permanently prevent occupation of habitat or migration from one Preble's habitat area to an adjacent Preble's habitat area.

Owners and operators of stormwater and wastewater systems should contact us when their maintenance activities have the potential to result in take of Preble's. We will work with wastewater and stormwater system owners and operators to develop maintenance procedures that minimize and mitigate take of Preble's when maintenance activities occur within Preble's habitat.

We prepared a Record of Compliance for the May 22, 2001, final rule that exempted from the take prohibitions listed in section 9 of the Act, the four activities of rodent control, ongoing agricultural activities, landscaping, and ongoing use of existing water rights. A Record of Compliance certifies that a rulemaking action complies with the various statutory, Executive Order, and Department Manual requirements applicable to rulemaking. Amendment of the May 22, 2001, rule to include the two additional exemptions adopted herein, noxious weed control and ongoing ditch maintenance, does not add any significant elements to this Record of Compliance.

Without this amendment, noxious weed control or ongoing ditch maintenance activities that may result in take of Preble's would not be exempted from the take prohibitions. This rule allows certain affected landowners to engage in certain noxious weed control and ditch maintenance activities that may result in take of Preble's. Without this rule, anyone engaging in those activities would need to seek an authorization from us through an incidental take permit under section 10(a)(1)(b) or an incidental take statement under section 7(a)(2) of the Act. This process takes time and can involve an economic cost. The rule allows these landowners to avoid the costs associated with abstaining from conducting these activities or with seeking an incidental take permit from us. These economic benefits, while important, do not rise to the level of “significant” under the following required determinations.

In accordance with the criteria in Executive Order 12866, the Office of Management and Budget has determined that this rule is not a significant regulatory action. This rule does not have an annual economic impact of more than $100 million, or significantly affect any economic sector, productivity, jobs, the environment, or other units of government. This rule reduces the regulatory burden of the listing of the Preble's meadow jumping mouse under the Act as a threatened species by providing certain exemptions to the section 9 take prohibitions that currently apply throughout the Preble's range. These exemptions reduce the economic costs of the listing; therefore, the economic effect of the rule benefits landowners and the economy. This effect does not rise to the level of “significant” under Executive Order 12866.

This rule should not create inconsistencies with other Federal agencies' actions. Other Federal agencies are mostly unaffected by this rule.

This rule should not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. Because this rule allows landowners to continue otherwise prohibited activities without first obtaining individual authorization, the rule's impacts on affected landowners is positive.

This rule should not raise novel legal or policy issues. We have previously promulgated section 4(d) rules for other species, including the special rule for the Preble's pertaining to rodent control, ongoing agricultural activities, landscaping, and activities associated with water rights. This rule simply adds exempted activities to that rule.

We have determined that this rule does not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). An initial regulatory flexibility analysis is not required, and a Small Entity Compliance Guide is not required. This rule reduces the regulatory burden of the listing of the Preble's as a threatened species. Without the final special rule and this amendment, all of the take prohibitions listed in section 9 of the Act would apply throughout the range of the Preble's. This amended rule allows certain affected landowners to engage in noxious weed control and ditch maintenance activities that may result in take of Preble's. This rule enables these landowners to avoid the costs associated with abstaining from conducting these activities to avoid take of Preble's or seeking incidental take permits from us.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule does not have an annual effect on the economy of $100 million or more; does not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises. As described above, this rule reduces regulatory burdens on affected entities, who are mostly agricultural producers.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501, et seq. ), this rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. This rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A Small Government Agency Plan is not required.

In accordance with Executive Order 12630, this rule does not have significant takings implications. By reducing the regulatory burden placed on affected landowners resulting from the listing of the Preble's as a threatened species, this rule reduces the likelihood of potential takings. Affected landowners have more freedom to pursue activities, i.e. , noxious weed control and ditch maintenance, that may result in take of Preble's without first obtaining individual authorization.

In accordance with Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism assessment. Currently, the State of Colorado, the Service, and various local governmental entities in Colorado and Wyoming are working together to develop plans to conserve the Preble's and its habitat. This collaborative approach is expected to result in the development of Habitat Conservation Plans that should provide the foundation upon which to build a lasting, effective, and efficient conservation program for the Preble's. Because we anticipate beneficial impacts of such collaborative conservation efforts, this rule is applicable only until the end of the 36-month timeframe of the May 22, 2001, special rule.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order.

We have examined this amended rule under the Paperwork Reduction Act of 1995 and found it to contain no requests for information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The National Environmental Policy Act analysis has been conducted. An Environmental Assessment was prepared for the final special rule. The additional exemptions covered in this amended rule were included in this analysis.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations With Native American Tribal Governments” (59 FR 22951) and E.O. 13175, we have evaluated possible effects on federally recognized Indian Tribes. We have determined that, because no Indian trust resources occur within the range of the Preble's, this rule has no effects on federally recognized Indian Tribes.

We have evaluated this amended rule in accordance with E.O. 13211 and have determined that this rule has no effects on energy supply, distribution, or use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

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

On May 28, 1999, NMFS published in the Federal Register (64 FR 29090) final regulations, effective July 1, 1999, implementing the HMS FMP that was adopted and made available to the public in April 1999. The HMS FMP and its implementing regulations require that NMFS issue quota specifications and effort controls for the BFT fisheries on an annual basis in accordance with internationally set quotas and domestic allocations. Further background information and rationale for these final initial quota specifications and General category effort controls were contained in the proposed initial quota specifications and effort controls (67 FR 43266, June 27, 2002) and are not repeated here.

The final initial quota specifications are necessary to implement the 1998 ICCAT recommendation, which established a rebuilding program for Western Atlantic BFT and is required by ATCA, and to achieve domestic management objectives under the Magnuson-Stevens Act. In accordance with the HMS FMP, the final initial quota specifications allocate the total ICCAT-recommended quota, including carryover of unharvested 2001 fishing year quota, among the established domestic fishing categories and are consistent with the BFT rebuilding program.

NMFS issues the 2002 fishing year (June 1, 2002—May 31, 2003) BFT final initial quota specifications under the annual and inseason adjustment procedures of the HMS FMP. Also, in accordance with the HMS FMP, NMFS announces the General category effort control schedule, including time-period subquotas and restricted fishing days (RFDs), for the 2002 fishing year. The final initial quota specifications may subsequently be adjusted during the course of the fishing year, consistent with the provisions of the HMS FMP. Notice of any such adjustments will be published in the Federal Register .

Based upon consideration of public comments received during the comment period, NMFS is revising the number of RFDs proposed for the 2002 fishing year. The revised schedule is indicted in the section addressing effort controls. Specifically, NMFS is not implementing the RFDs proposed for August, September, or early October, and is implementing RFDs for portions of October, and November. The intent of these revisions is to help spread out fishing effort, slow the pace of landings only when catch rates are likely to be high, and extend the fishery. In addition, minor modifications have been made to the 2002 fishing year quotas based on revised landings for the 2001 fishing year.

The HMS FMP and its implementing regulations established baseline percentage quota shares of the ICCAT-recommended U.S. BFT quota for each of the domestic fishing categories. These percentage shares were based on allocation procedures that had been developed by NMFS over several years. The baseline percentage quota shares established in the HMS FMP for fishing years beginning June 1, 1999 are as follows: General category—47.1 percent; Harpoon category—3.9 percent; Purse Seine category—18.6 percent; Angling category—19.7 percent; Longline category—8.1 percent; Trap category—0.1 percent; and Reserve—2.5 percent.

The current ICCAT BFT quota recommendation allows, and U.S. regulations require, the addition or subtraction, as appropriate, of any underharvest or overharvest in a fishing year to the following fishing year, provided that such carryover does not result in overharvest of the total annual quota and is consistent with all applicable ICCAT recommendations, including restrictions on landings of school BFT. Therefore, NMFS adjusts the 2002 fishing year quota specifications for the BFT fishery to account for underharvest and overharvest in the 2001 fishing year.

In accordance with ICCAT recommendations and the regulations regarding BFT quota allocation at § 635.27(a), the total landings quota will be divided among domestic user groups based on these established percentage shares mentioned above. NMFS may apportion a landings quota allocated to any category to specified fishing periods or to geographical areas. Based on these established procedures NMFS finalizes specifications for the 2002 fishing year that include carryover adjustments. The final initial quotas are: General category—647.0 mt; Harpoon category—75.9 mt; Purse Seine category—317.7 mt; Angling category—429.0 mt; Longline category—140.7 mt; and Trap category—2.3 mt. Additionally, 75.3 mt would be reserved for inseason allocations or to cover scientific research collection and potential overharvest in any category except the Purse Seine category. Regulations at 50 CFR 635.27(a)(9)(i) require Purse Seine category under or overharvests to be subtracted from or added to each individual vessel's quota allocation, as appropriate.

These final initial quotas include provisions for each category to carry forward any underharvest from 2001 to the 2002 fishing year. An exception is the unused school reserve (approximately 20.1 mt) from 2001, along with an additional 20.0 mt of unused Longline South subcategory quota, which are placed into the Reserve. This additional reserve quota will be allocated among the domestic fishing categories, as appropriate, during the 2002 fishing year, in accordance with the inseason transfer criteria in the HMS regulations.

As part of the BFT rebuilding program, ICCAT recommended an allowance for dead discards. The U.S. dead discard allowance is 68 mt. The 2000 calendar year preliminary estimate of U.S. dead discards, as reported in pelagic longline vessel logbooks, totaled 67.0 mt (U.S. National Report to ICCAT 2001). As estimates of BFT dead discards for the 2001 fishing year will not be available for some time, the estimate for the 2000 calendar year was used to calculate the amount to be added to, or subtracted from, the U.S. BFT landings quota for 2002 as a result of dead discards. Estimates of dead discards from other gear types and fishing sectors that do not use the pelagic longline vessel logbook are unavailable at this time and thus are not included in this calculation. As U.S. fishing activity is estimated to have resulted in less dead discards than its allowance, the ICCAT recommendation and U.S. regulations state that the U.S. may add one half of the difference between the amount of dead discards and the allowance (i.e., 68.0 mt- 67.0 mt = 1.0 mt, 1.0 mt/2 = 0.5 mt) to its total allowed landings for the following year, or to individual fishing categories or to the Reserve. NMFS allocates the 0.5 mt to the Reserve quota, which may then be allocated to individual fishing categories as necessary during the fishing year.

Based on the final initial specifications, the Angling category quota of 429.0 mt would be divided as follows: School BFT—175.1 mt, with 98.1 mt to the northern area (north of 39° 18′ N. lat.), 77.0 mt to the southern area (south of 39° 18′ N. lat.), plus 20.5 mt held in reserve; large school/small medium BFT—226.2 mt, with 120.5 mt to the northern area and 105.7 mt to the southern area; and large medium/giant BFT—7.2 mt, with 3.0 mt to the northern area and 4.2 mt to the southern area. These subquotas reflect the adjusted north-south dividing line (39° 18′ N. lat.) and percentage quota allocations in the northern and southern areas for the Angling category, as implemented by NMFS through a final rule on August 15, 2001 (66 FR 42801).

The Longline category quota of 140.7 mt would be subdivided as follows: 30.3 mt to longline vessels landing BFT north of 34° N. lat. and 110.4 mt to longline vessels landing BFT south of 34° N. lat.

For the last several years, NMFS has implemented General category time-period subquotas to increase the likelihood that fishing would continue throughout the entire fishing season. The subquotas are consistent with the objectives of the HMS FMP and are designed to address concerns regarding allocation of fishing opportunities, to assist with distribution and achievement of optimum yield, to allow for a late season fishery, and to improve market conditions and scientific monitoring.

The HMS FMP divides the annual General category quota into three time-period subquotas as follows: 60 percent for June-August, 30 percent for September, and 10 percent for October-December. These percentages would be applied to the adjusted 2002 coastwide quota for the General category of 637.0 mt, with the remaining 10.0 mt being reserved for the New York Bight fishery. Therefore, coastwide, 382.2 mt would be available in the period beginning June 1 and ending August 31; 191.1 mt would be available in the period beginning September 1 and ending September 30; and 63.7 mt would be available in the period beginning October 1 and ending December 31, 2002.

In addition to time-period subquotas, NMFS also has implemented General category RFDs to extend the fishing season throughout the entire General category BFT season. The RFDs are consistent with the objectives of the HMS FMP and are designed to address the same issues addressed by time-period subquotas. This year a substantial amount of General category quota carried over from the June-August time-period subquota to the September time-period subquota due to low catch rates. Catch rates of BFT in the General category appear to have shifted in recent years from a pattern of high catch rates in the summer (June-August time period) and lower catch rates in the fall/winter (September-December time period) to a pattern of low catch rates in the summer and higher catch rates in the fall/winter. NMFS has typically adjusted retention limits and scheduled RFDs in the summer to spread out fishing effort, slow catch rates, and extend the fishery. In recent years, NMFS had not implemented many RFDs in the fall/winter since most of the available quota had already been caught. Given the shift in catch rate pattern, NMFS believes that higher retention limits and fewer RFDs (if any) in the summer and more RFDs (and possibly, lower retention limits) in the fall/winter are appropriate to meet the objectives of maximum utilization of available quotas and equitable fishing opportunities.

Due to this apparent shift in catch rates, NMFS announces the final 2002 fishing year RFD schedule. Persons aboard vessels permitted in the General category are prohibited from fishing, including tag-and-release fishing, for BFT of all sizes on the following days: October 13, 14, 16, 20, 21, 23, 27, 28, and 30; November 13, 17, 18, 20, 24, 25, and 27. These RFDs will improve distribution of fishing opportunities without increasing BFT mortality. The above RFD schedule may be adjusted upon consideration of actual catch rates relative to the available quota in each category.

Comment 1: Some commenters stated that NMFS should remove all RFDs because recent catch rates do not justify maintaining them as a management tool and they have impeded fishermen from having a reasonable opportunity to land the quotas previously established for particular time periods. Other commenters stated that NMFS should use its ability to institute RFDs during the season as necessary, based on some pre-determined sustained catch rate. Some comments received stated that the RFD schedule should remain as it was finalized last year to extend the season as long as possible. Many commented that NMFS should implement RFDs in the October through December time period subquota to ensure that the southern states have an equal opportunity to harvest the quota.

Response: NMFS has adjusted the RFD schedule from the schedule announced in the proposed specifications. NMFS had proposed three RFDs for the month of August. Based on a review of dealer reports, daily landing trends, and the availability of BFT on the fishing grounds, NMFS has determined that, for the months of August and September, the previously proposed RFDS should not be implemented. RFDs, in conjunction with the General category quota subdivision, help achieve HMS FMP objectives to achieve optimum yield and address allocation issues. In addition, maintaining the current pattern and schedule of RFDs provides some benefit to fishermen as it offers a certain level of predictability and, in particular, provides the South Atlantic states an opportunity to harvest General category quota. However, over the past several years, landings have been highest during the later portion of the season, exacerbating the derby nature of the fishery and contributing to market gluts. Implementing RFDs for the later portion of the season may help spread out fishing effort, slow the pace of landings, and extend the fishery. However, NMFS recognizes that the weather is unpredictable during this time period for the fishery, particularly in the later half of October and early November, and that poor weather conditions may limit participation without the need for additional RFDs during this part of the season. Should BFT landings and catch rates during the late season fishery merit the waiving of RFDs, NMFS could adjust the daily retention limits with a minimum 3-day notification to fisherman, and through publication of this adjustment in the Federal Register , under 50 CFR 635.23(a)(4).

Comment 2: NMFS should reinstate the incidental catch quota for herring purse seine vessels and include mid-water trawlers as well, which occasionally catch BFT incidental to their target species.

Response: NMFS evaluated gear types used in the Atlantic tuna fisheries during the development of the HMS FMP and determined that, in order to facilitate enforcement against unauthorized landings of BFT, only fixed “trap” gear types (i.e., pound nets and fish weirs) were eligible for incidentally caught BFT in the renamed Trap category. NMFS suggests that interested parties consult with their representatives on the HMS Advisory Panel (AP) to provide comments/guidance during the next HMS AP meeting.

Comment 3: NMFS received many comments that North Carolina (NC) should have its own General and Angling category set aside quotas. Some commenters stated that by not allowing NC a commercial fishery NMFS may be in violation of National Standard 4. These commenters also stated that the current General category allocation scheme discriminates between residents of different states and fails to provide equitable fishing opportunities across different geographical areas. Comments also requested that there be a December time-period subquota established for southern states. Other comments received stated that historical fisheries must be restored before any new fisheries, such as a commercial handgear fishery in NC, are created.

Response: NMFS maintains the current quota allocation scheme and has not implemented a specific set-aside quota for NC. Fishermen in the state of NC have the opportunity to fish recreationally under the Angling category bag limits, and NMFS has the ability to open and close the Angling category to ensure reasonable fishing opportunities in all areas, including NC. Thus, NMFS does not believe a set-aside of Angling category quota is necessary for NC or any other area. During FMP development, the issue of opening a southern commercial BFT fishery and establishing a set-aside for a NC General category fishery was extensively discussed by the HMS AP and the public. However, the HMS AP did not reach consensus on how to address the requests for a southern commercial fishery. NMFS maintains its position that allowing new gear types and/or increasing the scale of fisheries for BFT would not be consistent with the rebuilding plan currently in place. NMFS is currently assessing the magnitude and scope of the fishing activities, and is continuing to work with the HMS AP on issues associated with a NC General category BFT fishery. NMFS maintains the status quo time-period subquota breakdown in the 2002 final initial specifications. Long-term effort controls were addressed in the HMS FMP to achieve a variety of FMP objectives. Specifically, the status quo regime for the General category assists attainment of optimum yield, and addresses allocation issues by lengthening the season over time and space in a category with high participation and catch rates.

Pursuant to 50 CFR 635.27(a)(8), NMFS also has the authority to transfer quotas among categories, or, as appropriate, subcategories, of the fishery, after considering the following factors: (1) The usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock; (2) the catches of the particular category quota to date and the likelihood of closure of that segment of the fishery if no allocation is made; (3) the projected ability of the vessels fishing under the particular category quota to harvest the additional amount of BFT before the end of the fishing year; (4) the estimated amounts by which quotas established for other gear segments of the fishery might be exceeded; (5) the effects of the transfer on BFT rebuilding and overfishing; and (6) the effects of the transfer on accomplishing the objectives of the HMS FMP. If it is determined, based on the above factors and the probability of exceeding the total quota, that vessels fishing under any category or subcategory quota are not likely to take that quota, NMFS may transfer inseason any portion of the remaining quota of that fishing category to any other fishing category or to the Reserve quota. Such transfers could address the concerns of those participants in the late season fisheries.

Comment 4: An incidental take allowance of Large school/Small medium BFT should be allowed for commercial handgear vessels. Historically, the Large school/Small medium size class BFT were caught by General category vessels and were sold or retained for personal use. Commenters asserted that, due to a change in 1991, there has been no fishery for that size class to speak of, resulting in a potential for unharvested quota and increased regulatory discards. Commenters stated NMFS should allow commercial handgear vessels an annual allowance of BFT below the commercial minimum size to alleviate some of this excess quota carryover and to minimize waste of the BFT resource.

Response: NMFS maintains the 73-inch (185-cm) commercial minimum size at this time. With the development of an international market in Japan for giant BFT and high ex-vessel prices, the distinction between U.S. recreational and commercial fisheries for BFT became blurred and much of the traditional recreational catch for medium and giant BFT was being sold for shipment to Japan. In 1992, NMFS responded by implementing the current commercial minimum size limit and this limit was maintained in the HMS FMP, as it is consistent with the objectives of the HMS FMP and achieving optimum yield in the fishery. By lowering the commercial minimum size to allow incidental takes, the number of BFT landed (hence, mortality) could increase, which may affect long-term rebuilding. Currently, all BFT less than 73 inches (185 cm) are allocated to the Angling category, and lowering the commercial minimum size to allow the sale of these fish by vessels in commercial permit categories would be considered a re-allocation of quota, which is beyond the scope of this rulemaking.

Comment 5: Some commenters stated that NMFS should use multiple fish retention limits in the General category to assure that time-period sub-quotas are harvested within their allotted time frame. Some stated that multiple fish retention limits should be implemented early in the season, while others stated that they should be implemented in the end of the season.

Response: NMFS maintains the authority to increase or decrease the General category daily retention limit of large medium and giant BFT over a range from zero to a maximum of three per vessel. NMFS may use this flexibility in the daily limit to provide fishermen a reasonable opportunity to achieve the General category quota. Starting the season with a multiple fish retention limit could work to the fishermen's disadvantage if the season has to be closed early in the fishing year. Starting at one large medium or giant per day should provide the greatest opportunity for a longer season, thus providing maximum fishing opportunities to the greatest number of fishery participants over the greatest geographic area.

Comment 6: NMFS should use the previous fishing year's final initial quota specifications as the proposed specification in the following year.

Response: Due to the varying and complex nature of the BFT fisheries from year to year, as well as the results of inseason transfers and adjustment due to underharvests and/or overharvests from one year to the next, domestic quota category allocations could significantly change. Thus, the specification from one year may not correspond well for a following year. NMFS suggests that interested parties consult with their representatives on the HMS AP to provide comments/guidance on the quota specification process during the next HMS AP meeting.

Comment 7: The General category fishery should not have a cap date of December 31, but should continue through March.

Response: Prior to implementation of the HMS FMP in 1999, the Atlantic tunas fishing year coincided with the calendar year, with the General category season ending December 31. These time-period subquotas were selected as the preferred alternative and final action in the HMS FMP. The FMP also established the Atlantic tunas fishing year as June through May 31 of the following year. As specified in the HMS FMP, the change to the new fishing year was not intended to authorize new fishing seasons or change fishing patterns. NMFS has stated its intent clearly in the HMS FMP and several other NMFS documents, including the 2000 final annual specifications published on July 12, 2000 (65 FR 42883), which indicate an end date of December 31 for the General category season. Adjustments to this end date would require a separate rulemaking. NMFS would need to assess the potential impacts and the order of magnitude of the fishing activities that would be associated with January through March General category BFT fishery. NMFS suggests that interested parties consult with their representatives on the HMS AP to provide comments/guidance on the season length during the next HMS AP meeting.

The 2002 BFT fishing year runs from June 1, 2002 through May 31, 2003. Development of BFT quota specifications and effort controls is dependent upon landings information from the previous fishing season. However, final landings data are not available before the start of the new season. When the proposed rule for this action was issued on June 27, 2002, the 2001 BFT landings data upon which it relied were preliminary and subject to change. NMFS may receive further data on 2001 landings in the future, thus these final initial specifications may be adjusted later in the 2002 season. Notice of any such adjustments will be published in the Federal Register .

These final initial specifications and effort controls are published under the authority of the Magnuson-Stevens Act, 16 U.S.C. 1801 et seq. , and the Atlantic Tunas Convention Act, 16 U.S.C. 971 et seq. The AA has determined that the final initial specifications and the effort controls are consistent with the HMS FMP, the Magnuson-Stevens Act, and the 1998 ICCAT BFT catch recommendation.

The Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration when these initial quota specifications and General category effort controls were proposed that, if adopted, they would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification may be found in the proposed initial specifications (67 FR 43266). No comments were received regarding the differential economic impacts of these quota specifications on small entities. Accordingly, neither an Initial nor Final Regulatory Flexibility Analysis was prepared.

These final initial quota specifications and General category effort controls have been determined to be not significant for purposes of Executive Order 12866.

On September 7, 2000, NMFS reinitiated formal consultation for all HMS commercial fisheries under section 7 of the Endangered Species Act. A Biological Opinion (BiOp) issued June 14, 2001, concluded that continued operation of the Atlantic pelagic longline fishery is likely to jeopardize the continued existence of endangered and threatened sea turtle species under NMFS jurisdiction. NMFS issued a final rule on July 9, 2002 (67 FR 45393), to implement the reasonable and prudent alternative required by the BiOp. These final initial quota specifications and effort controls would not have any additional impact on sea turtles as these actions would not likely increase or decrease pelagic longline effort, nor are they expected to shift effort into other fishing areas. No irreversible or irretrievable commitments of resources are expected from this action that would adversely affect the implementation of the requirements of the BiOp.

The area in which this final action is planned has been identified as essential fish habitat (EFH) for species managed by the New England Fishery Management Council, the Mid-Atlantic Fishery Management Council, the South Atlantic Fishery Management Council, the Gulf of Mexico Fishery Management Council, the Caribbean Fishery Management Council, and the Highly Migratory Species Management Division of the Office of Sustainable Fisheries at NMFS. It is not anticipated that this action will have any adverse impacts to EFH and, therefore, no consultation is required.

To ensure that the United States' actions are consistent with international obligations under ICCAT, and because the fishing season is underway, it is essential that these bluefin tuna (BFT) quota specifications and General category effort controls are effective upon publication. Therefore, pursuant to 5 U.S.C. 552 (d)(3), NMFS has determined that there is good cause to waive the 30-day delay of the effective date. NMFS will rapidly communicate these final initial specifications to affected fishermen through its FAX network.