This rule has been determined to be significant under E.O. 12866 and has been reviewed by the Office of Management and Budget.

In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-602), the undersigned has determined and certified by signature of this document that this rule will not have a significant economic impact on a substantial number of small entities. New provisions included in this rule will not impact a substantial number of small entities to a greater extent than large entities. Thus, large entities are subject to these rules to the same extent as small entities. Therefore, a regulatory flexibility analysis was not performed.

This document has been reviewed in accordance with 7 CFR part 1940, subpart G, “Environmental Program.” The issuing agency has determined that this action does not affect the quality of human environment, and in accordance with the National Environmental Policy Act of 1969, Pub. L. 91-190, an Environmental Impact Statement is not required.

This rule has been reviewed in accordance with E.O. 12988, Civil Justice Reform. In accordance with this rule: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings in accordance with 7 CFR parts 11 and 780 must be exhausted before bringing suit in court challenging action taken under this rule.

For reasons set forth in the Notice related to 7 CFR part 3015, subpart V (48 FR 29115, June 24, 1983), the programs within this rule are excluded from the scope of E.O. 12372, which requires intergovernmental consultation with State and local officials.

It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government. The rule does not add any new significant loan making criteria, but changes the format of the regulation in compliance with efforts to streamline our loan making and loan servicing criteria.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), requires Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments or the private sector of $100 million or more in any 1 year. When a rule contains such mandates, section 205 of the UMRA requires agencies to prepare a written statement, including a cost benefit assessment, for proposed and final rules with “Federal mandates” that may result in such expenditures for State, local, or Tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule.

This rule contains no Federal mandates, as defined under Title II of the UMRA, for State, local, and Tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The Agency announced its intent to obtain Office of Management and Budget (OMB) approval of the information collections established under 7 CFR part 770 under a new OMB control number in the notice of proposed rule (64 FR 59131). No comments were received from the public regarding the proposed information collections and the Agency has requested OMB approval.

These changes affect the following FSA programs as listed in the Catalog of Federal Domestic Assistance.

10.421—Indian Tribes and Tribal Corporation Loans.

On November 2, 1999, the Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and the Farm Service Agency published a Proposed Rule (64 FR 59131) requesting comments regarding proposed changes to ITLAP. On March 31, 2000, an extension to the comment period was published. In response to the request for public comment, 29 comments were received. The breakdown of the five groups and or individuals who commented were: Three Native American tribes, one individual and one Federal Government agency.

Four comments were received regarding the cancellation of ITLAP debt. One comment opposed reducing or canceling any ITLAP debt that is fully secured and collectable because (1) The Federal Government has an affirmative responsibility to collect such debt and to not take that action turns the loans into grants and (2) it would violate the appropriations process. Three comments supported the cancellation of debt in some unspecified form, or supported a broad based cancellation of the debt. In response to the comment that the Agency not reduce any ITLAP debt that is fully secured and collectable, these loans are based upon the value of the land purchased and not the general assignment of income that is generally subordinated by the tribe to the Agency to secure repayment. The general assignment of funds comes from all tribal sources and not just the income generated from the land. So while the repayment is secured by the assignment, many loans are in fact not fully collateralized based upon the value of the land. It is the intent of the Agency in the final rule in situations where certain tribal economic impact factors are extreme to provide a mechanism for debt reduction, thereby reducing tribal payments to be more in line with the value of the lands purchased with these loan funds.

Also, while we agree that the Federal Government has an affirmative responsibility to collect its legitimate debts in accordance with various statutes, the Federal Government also has an affirmative responsibility to manage its loan programs in a manner that takes into consideration economic realities and circumstances beyond the control of participants in its loan programs. The Agency is not turning loans into grants but simply providing options for loan restructuring and debt relief for those who qualify. Providing such measures is consistent with actions taken to provide assistance to all program applicants in other Federal loan programs. However, the Agency has determined that it will limit the term of restructured loans to remain within the maximum 40-year term to help balance the needs of tribes for relief from economic hardship with the need to protect the financial integrity of government loan programs.

In response to the comments that suggested the Agency adopt a policy of canceling ITLAP debt, the Agency cannot justify the simple cancellation of ITLAP debt with respect to the program's current borrowers or future borrowers. Such an action would be inconsistent with the intent of the program, which is to provide credit to Native American tribes for the purchase of reservation land. When Congress amended the ITLAP legislation in 1989 (sec. 303 of Pub. L. 101-82) to authorize debt relief, it tied such relief to changes in the value of the land. In this amendment, Congress did not suggest or encourage the Agency to use its debt settlement authorities to provide broad debt relief. While comments to the proposed regulations did suggest new eligibility criteria and specifics on debt reduction, which are addressed here, none of the comments provided specific criteria to support when complete cancellation of debt should take place. Also, providing such relief could jeopardize the future of ITLAP because, at a minimum, if such relief is not clearly limited, it could substantially increase the projected costs for future ITLAP loans. The increased loan losses would mean that under the Credit Reform Act of 1990, the cost of loans would increase which would result in the Agency having less program loan funding available for such loans, even if the appropriation level of the program remains unchanged. The decreased funding would have a negative impact on ITLAP applicants. Therefore, the Agency has concluded at this point that the proposal of broadly canceling ITLAP debts will not be implemented.

Three respondents submitted comments regarding the methodology and eligibility for reducing the principal amount of the outstanding ITLAP debt to the present value of expected future annual rental value of the land purchased with ITLAP loan funds and setting the annual ITLAP loan payment at the annual rent received or that could be received from this land. Two of these comments stated that the principal balance of such loans should be reduced to the present value of future annual rents that could be generated on the land purchased with loan funds. Two comments supported the concept that loan payments should be adjusted to equal rental income received from land purchased with loan funds. In addition, one comment suggested that eligibility for debt relief be tied to the unusually high rates of unemployment encountered on Native American reservations. Three comments supported eligibility criteria based upon socio-economic factors but indicated that the proposed rule criteria was too complicated and terms such as unfunded mandates and quantifying public health and safety needs could never be accurately measured. These comments are indicative that many tribes are having or have experienced severe socio-economic problems and are finding it difficult to meet the basic needs of their members. As a result, the Agency has determined that debt relief to an ITLAP borrower could be extended to those who face extreme poverty and unemployment.

The final rule contains a provision that would allow an ITLAP loan to be written down to a level where annual loan payments are based upon the previous 5-year average annual rental payment received for the land purchased with loan funds projected over the remaining term of the loan. The rental rate information will be obtained from the Native American tribe or tribal corporation and verified with the Department of Interior. This would occur if the Native American tribe is facing extreme socio-economic problems, which are a part of the eligibility criteria for debt relief. In further response to the comments the Agency has changed the eligibility criteria to include socio-economic factors that are more easily measured, such as per capita income and tribal unemployment. However, a Native American tribe's loan could receive the benefit of such a write-down regarding its ITLAP loans only once, provided it has not received a land value write-down in the last 5 years. Such a write-down could involve as many ITLAP loans of the tribe as meet the criteria under this regulation at the time of the write-down application.

Two comments were received with regard to the number of years used to determine the average rental value of the land purchased under the rental value write-down option. The commenters believed that the Agency did not go far enough in using the preceding 5 years to determine the average rental value of the land purchased with loan funds. The commenters contended that the entire history of the rental value of the land should be considered because there have been several periods over the life of the existing loans during which tribes have suffered financial hardships. The Agency considered these comments but any write-down must be based upon an accurate representation of the value of the land. To go back more than 5 years could result in a misstatement of the current land value. It is not the purpose of the rental value write-down option to compensate the borrower for financial hardship that it may have suffered in the past. The purpose of the new write-down servicing option is to provide a measure of relief, if necessary based upon the most recent indicators of land value.

One comment was received regarding the restructuring of a loan by lowering the interest rate and reamortizing the balance of the loan over the remaining loan term. The comments were not opposed to lowering the interest rate but were opposed to reamortizing over the remaining term. They felt that keeping within the remaining term when no debt relief is proposed simply increases a payment that already cannot be met. This comment also referred to year 40 of the note as the balloon payment date. In response, the Agency feels that routine loan restructuring should take place when necessitated by temporary circumstances and should be reamortized within the original note terms in order to stay within the budgetary confines of program allocations and to project a realistic repayment schedule for the loan. Also, the Agency is publishing a deferral option in the final rule that will further provide for temporary relief. If long-term problems are encountered the debt-relief provisions of this rule should be explored. In response to the balloon payment reference, the Agency believes that 40 years is a more than adequate repayment period for any note. Under the equal amortization schedule the note is set up or restructured under, year 40 is the final due date of the last installment and not a balloon payment.

Two comments suggested that ITLAP borrowers should be eligible for servicing options, such as reamortizations and deferrals (codified at 7 CFR part 1951, subpart S), and debt settlement options (codified at 7 CFR part 1956) that are available to Farm Loan Program (FLP) borrowers. Based on a review of the FLP loan-making and servicing procedures, we have determined that loan-making and servicing procedures for FLP are not consistent with the statutorily established purposes of ITLAP. The purpose of FLP loans is to assist family farming and ranching operations in becoming economically successful. Conversely, the statutory purpose of ITLAP loans is to assist Native American tribes in the purchase of land and interests in land for the purpose of consolidating their ownership of land within their reservations, regardless of the economic use such tribe may make of the land. Thus, FLP loans made to farmers and ranchers versus ITLAP loans made to Native American tribes are substantially different in the types of borrowers being targeted, the importance of how the borrower's operation is structured, and the importance of the economic viability of the project being funded. In order to accomplish the purpose of these respective loan programs, the servicing options offered to borrowers under each program must be different and tailored to the distinct purposes of these programs. With respect to debt settlement, for individual loans the security must be liquidated in order to debt settle. In many cases, even when the security is liquidated a debt settlement is not granted until a borrower makes a compromise offer to settle the remaining indebtedness even though all the collateral has been liquidated. The comments received considered this but felt that land holdings on the reservation are unique because they are generally secured by payment assignments, so collateral liquidation provisions should not apply. To the extent that a final debt settlement procedure is necessary, the Agency will use the general government procedures at (4 CFR parts 101-105). The final rule implements loan servicing and debt write-down provisions that are specially tailored and unique to ITLAP and will maintain the economic viability of tribal lands purchased with ITLAP funds.

Three comments were received regarding releasing assignments of income and substituting real estate mortgages on the land purchased with ITLAP funds. The comments suggest that the Agency take mortgages as security for these existing loans in exchange for the release of the general assignments of income that currently secure many of these loans. The Agency does not agree with these comments. The assignment guarantees repayment and since the ITLAP program is a credit program the Agency is responsible for providing the best possible method of collecting taxpayer dollars loaned. Also, in many of these cases taking security in the form of a mortgage is not practical because the ITLAP funds are being used to purchase fractional interests in land. A mortgage on such fractional interests may not provide the Agency with adequate security for the loan. However, the Agency is eliminating the reserve account requirement for all new loans and providing reserve account release criteria for existing loans in this rule. The reserve is set up for tribes to pay and deposit one-tenth of their regularly scheduled payment in the account until one full payment is in reserve. The release may help to free funds for borrowers to use in other areas rather than have them tied up in the reserve account.

One comment was received regarding granting of deferrals of annual payments if the income loss is temporary. The comment recommended that debt relief should be provided when a producer who rents land from the borrower suffers a reduction in commodity prices. The Agency agrees and has provided specific deferral criteria in § 770.10(c) of the final rule.

One comment suggested that debt relief should be provided if the making of the loan payments by the borrower will impede the borrower's ability to resolve fractional land interests on the reservation. One comment stated that debt relief should be provided if the making of loan payments impedes the borrower's ability to repay other loans or meet other tribal needs. In response, the ITLAP program that provides credit for a tribe to purchase land is not a program designed to solve all tribal needs, nor could it possibly be designed to do so. If tribes have other payment obligations, they may also approach those creditors for relief. ITLAP is a loan program in which tribes recognize their repayment responsibilities when entering into the loan. The Agency cannot promulgate regulations that simply allow a borrower to not make payments because it has decided that purchasing additional lands is a priority.

Two comments indicated that the Agency should take action regarding debt relief without promulgating new regulations, since such regulations are not necessary and would violate Executive Order (E.O.) 13084. These comments indicated that the E.O. obligates the Secretary of Agriculture to take actions to assist Native American tribes while waiving the normal regulatory requirements to take such actions. The Agency agrees that the E.O. does place an obligation on the Secretary of Agriculture to take steps wherever possible to assist Native American tribes. As indicated in the Proposed Rule the Agency re-examined ITLAP to determine if there are ways in which the Agency can provide more debt relief options to borrowers. The Agency, however, does not agree that the E.O. would allow the Agency to implement such policy changes in violation of the requirements of notice and comment rulemaking requirements in section 553 of Title 5, United States Code and the Statement of Policy of the Secretary of Agriculture relating to notices of proposed rulemaking and public participation (36 FR 13804). Further, while the public notification and subsequent comment periods of the informal rulemaking process has taken additional time, this process has given all interested parties, including affected Native American tribes, the opportunity to participate in the development of this final rule, thus ensuring that their interests and concerns have been heard. Therefore, the Agency proceeded with the consideration and development of ITLAP debt relief changes through the notice and comment rulemaking process.

One comment indicated that the Agency's concerns regarding the budgetary impacts of providing debt relief to borrowers were misplaced because such relief would enable borrowers to purchase more fractional interests and thus reduce the overall Federal Government's costs in tracking these fractional interests. The comment indicated that any additional costs to the Federal Government would be offset by the reduction in costs to administer programs on Native American reservations. The comment indicated that this information is readily available from the Department of the Interior's Bureau of Indian Affairs and that a reduction in debt would have a corollary effect of reducing the costs incurred by the Federal Government of managing fractional interests within the confines of Federally Recognized Indian Reservations. Only authorizing legislation could allow for consideration of such a proposal. In addition, these comments ignore the Agency's concerns expressed in the Proposed Rule of the impact on the Federal budget that any ITLAP debt relief will have on the Agency and the reality of the Federal budgeting process.

One comment indicated that funding for the loan program should be provided to the full program authorization level of $50 million and that such a change would be in the best interests of the program. The Agency has no comment as the Congressional appropriation process establishes program funding levels, not the Agency.

One comment requested clarification on the definition of Reservation to include the former reservations in Oklahoma. While inclusion of these lands would be consistent with other FSA loan programs, the statute authorizing ITLAP, 25 U.S.C. 488, limits ITLAP loans to “interests * * * within the tribe's reservation as determined by the Secretary of the Interior or within a community in Alaska incorporated by the Secretary * * *” Former reservations lands are not covered by the ITLAP authorizing statute and thus the comment was not adopted.

One comment indicated that under the proposed land value or rental value write-down criteria the appraisal that would be necessary would be cost prohibitive because of fractionated interests in land. The Agency maintains that a value must be established prior to any write-down just as it was when the loans were originally made. If the appraisal cost is viewed as being excessive, then, as with any loan, the borrower will have to make a decision on what is in its best interest.

Two comments requested that any requirement for the tribe to waive its sovereign immunity be removed. The Agency agrees and will no longer require the waiver. The lack of a waiver does not prevent the Federal Government from bringing suit against the borrower.

One comment suggested that the Agency is not equipped to handle loans to tribes and that the ITLAP program should be transferred to an Agency that is better suited to understanding and working with tribal programs, such as the Department of the Interior. This type of a loan program transfer between departments of the Federal Government would require enacting legislation.

There were other comments relating to specifics of the Agency's internal administrative processing of various loan making or servicing actions. These comments and recommended actions are solely administrative in nature and will be covered in the Agency handbook.

Public Law 91-229 (25 U.S.C. 488-494) authorized the Secretary of Agriculture to establish ITLAP to make loans to Native American tribes and tribal corporations to acquire land and fractional interests in land on the tribes' reservations. This program was administered by the former Farmers Home Administration (FmHA). Under the authority of the Department of Agriculture Reorganization Act of 1994, Pub. L. 103-354, on October 20, 1994, FmHA's ITLAP functions were transferred to FSA. Regulations for implementing this program are found at 7 CFR part 1823, subpart N for loan making; 7 CFR part 1951, subpart E for loan servicing; and 7 CFR part 1956, subpart C, for debt settlement. The final rule will consolidate the ITLAP regulations into one part and clarify that this program is exclusively administered by FSA.

The final rule will eliminate the reserve account. With respect to loans that are not delinquent and that are presently adequately secured by a general assignment of tribal income, the Agency will release its interest in existing reserve accounts and allow them to be returned to the Native American tribe or tribal corporation. During the review of ITLAP in preparation of the proposed rule and the final rule, the Agency determined that a general assignment of tribal income provides the Agency sufficient security for ITLAP loans. The additional security provided by the reserve account is unnecessary. ITLAP loans secured by an assignment of income have a very low delinquency rate. The release of the reserve would allow Native American tribes and tribal corporations to use these funds towards an extra payment or for other tribal operations. Also, with this change, the borrowers could use the reserve account funds to purchase additional land that could increase its future income or for other pressing tribal needs. The Agency believes that these changes are consistent with the intent of ITLAP to assist Native American tribes and tribal corporations to consolidate their ownership in reservation lands.

The final rule also adopts the use of unemployment rates and tribal per capita income for enrolled tribal members as an eligibility criteria more easily obtainable than calculating the percentage or tribal shortfall to meet unfunded State or Federal mandates.

The final rule expands the use of ITLAP loan funds to include: Refinancing of an existing debt incurred by the Native American tribe or tribal corporation to purchase land, provided the loan application and land purchase proposal was received by the Agency and approved prior to the purchase of the land; the Native American tribe or tribal corporation was not able to obtain an option on the land; the debt to be refinanced is short term debt with a balloon payment that cannot otherwise be refinanced with the creditor; and the debt secured by the land subject to the refinancing must otherwise meet the requirements of ITLAP.

The final rule allows certain ITLAP loans to be written down to a value where the annual loan payment would equal the 5-year average rental value for the land purchased with such loan funds if the borrower could establish that the Native American tribe was facing economic hardships based on a combination of certain eligibility criteria. Such a write-down could involve as many ITLAP loans of the tribe as meet the criteria under this regulation at the time of the write-down application.

The final rule clarifies the process under which the Agency will reduce the interest rate of an ITLAP loan to the interest in effect at the time of application for such a reduction. Such a reduction will take place if the ITLAP loan has been in effect for more than 5 years. This change is being made to allow borrowers who have extreme impoverished circumstances to benefit from any program interest rate changes. Borrowers could qualify if the tribe has a per capita income for enrolled tribal members which is less than the Federally established poverty income rate by more than 50 percent and the tribal unemployment rate exceeds 50 percent.

The final rule clarifies the approved uses of land that are the subject of an ITLAP loan to ensure that the Agency's mortgage or income assignment on the land is protected by requiring Agency approval prior to such land being either leased, sold, or exchanged. The final rule clarifies that a subsequent ITLAP loan may be made to a borrower for the same purposes and under the same conditions as a prior loan. The final rule requires that prior to obtaining an ITLAP loan, the Native American tribe or tribal corporation must obtain an option or other acceptable purchase agreement to purchase the land at issue and that a copy of such agreement accompany the ITLAP loan application. The purpose for this change is to allow the Agency to have all relevant information regarding the land purchase for which ITLAP loan funds are being sought. The final rule will also eliminate the need for the tribe to waive their right to sovereign immunity as the Government will receive an assignment of income that has been approved by Department of Interior, Bureau of Indian Affairs, which serves to guarantee the repayment of the loan, negating the need for the waiver of sovereign immunity.

This rule has been determined to be significant and was reviewed by the Office of Management and Budget under Executive Order 12866.

This rule will not have a significant economic impact on a substantial number of small entities as defined in the Regulatory Flexibility Act, Public Law 96-534, as amended (5 U.S.C. 601) and does not impact small entities to a greater extent than large entities. Large entities are subject to these rules to the same extent as small entities. Therefore, a regulatory flexibility analysis was not performed.

It is the determination of the issuing agency that this action is not a major Federal action significantly affecting the environment. Therefore, in accordance with the National Environmental Policy Act of 1969, Public Law 91-190, and 7 CFR part 1940, subpart G, an Environmental Impact Statement is not required.

This rule has been reviewed in accordance with E.O. 12988, Civil Justice Reform. In accordance with this rule: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings in accordance with 7 CFR parts 11 and 780 must be exhausted before bringing suit in court challenging action taken under this rule unless those regulations specifically allow bringing suit at an earlier time.

For reasons set forth in the Notice to 7 CFR part 3015, subpart V (48 FR 29115, June 24, 1983,) the programs and activities within this rule are excluded from the scope of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, requires Federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments or the private sector. Agencies generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures of $100 million or more in any 1 year for State, local, or tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule.

The rule contains no Federal mandates, as defined under title II of the UMRA, for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The policies contained in this rule do not have any substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Nor does this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with the States is not required.

This interim rule does not impose any new information collection or recordkeeping requirements; however, the provisions of the rule do eliminate the need for some information previously collected and result in a revision to the number of estimated respondents from whom information will be collected. Therefore, the Agency is revising the information collection currently approved in support of the Direct Operating Loan program under the Office of Management and Budget (OMB) control number 0560-0178. OMB emergency clearance has been obtained to allow continued use of the affected regulations and forms under OMB control number 0560-0178.

Stress in the farm economy has significantly increased demand for FSA farm loans. The Agency must take steps to focus resources on larger, more complex cases that pose the highest risk to the government. The changes in documentation requirements will reduce the time for loan officials to review application information and make the necessary determinations. Decreasing the time required for FSA employees to reach both eligibility and feasibility determinations on lower risk loans increases the time available to concentrate on larger, higher risk loan applicants.

In fiscal year 1999, FSA made more than 16,000 direct OL's to farmers for a total of nearly $800 million. According to recent studies of FSA offices nationwide, the average FSA OL applicant expends 14.05 hours to complete the application to be submitted to FSA. Once this complete application is submitted to FSA another 39.55 hours is expended by FSA employees to reach both eligibility and feasibility determinations on each OL application.

Approximately 10,500, or 65 percent, of these applications are for loans of $50,000 or less. This group of applicants represents only 26 percent of the total direct OL dollars loaned in fiscal year 1999 and only 20 percent of the total FSA direct OL delinquency in dollars. These figures reflect the substantially lower risk involved with FSA direct OL's under $50,000 as compared to those FSA loans above this amount. The Lo-Doc loan regulations will primarily affect this group of FSA current and potential customers.

Reducing the application burden on both potential FSA customers and FSA employees will result in more timely assistance, so applicants will receive their FSA operating funds earlier in the production year. The most critical time period for farming operations nationwide is from pre-planting through planting seasons. This is also the peak demand period for operating capital in many types of farming operations. Without this proposed reduction in the application process many farmers would receive assistance so late in the year their production would be adversely affected, or they would otherwise go without credit for an extended period of time. For two years the farm economy has been in a continuing state of crisis due to excess supplies, weak foreign markets, and regional weather disasters. With the current financial difficulties facing agriculture, it is imperative that producers receive operating credit early in the spring season. Historical records reflect that the Agency approves the majority of OL's in the months of March and April. In order to meet the needs of farmers, the Agency is publishing this rule as an interim rule effective on date of publication. A delayed effective date, or publication of a proposed rule would adversely impact farmers as Lo-Doc OL's would not be available for the current operating season. Farmers eligible for FSA farm loans are unable to obtain credit elsewhere at reasonable rates and terms. Therefore, the Lo-Doc program needs to be effective upon publication. FSA, however, will accept comments for a 60 day comment period after publication to determine if the program should be subsequently modified.

FSA is revising its direct OL program regulations to reduce the application requirements for certain operating loan requests of $50,000 or less and for certain annual OL requests from recurring applicants.

Under current regulations, the application requirements are the same for all OL requests regardless of the amount of the loan or whether it is an initial or subsequent loan for the applicant. For example, an applicant requesting an OL of $5,000 is required to submit the same amount of information as an applicant requesting a $200,000 OL. An FSA customer who has received several OL loans is required to submit the same information as a new applicant requesting an initial OL. This excess paperwork is time-consuming for both the farmer and the FSA employee, who could be helping less experienced farmers whose loans pose a higher risk to the Government. Less experienced farmers normally need more personal attention to make financial progress and be successful in graduating to commercial credit.

Loan applicants and Agency field personnel have identified several application requirements that are repetitive or do not significantly contribute to the Agency's ability to make a credit decision, such as always requiring verifications of employment and verifying the same debt in numerous ways. The Agency is amending its regulation to eliminate requirements that are repetitive or do not contribute significantly to a sound credit decision in light of the financial risk involved.

In addition, application requirements and loan purpose requirements are being amended as follows:

Certain loan applicants submitting requests for operating loans of $50,000 or less will only be required to submit the following: a signed and dated FSA 410-1, “Request for Direct Loan Assistance,” a check or money order for credit report and lien filing fees, a Farm and Home Plan for the next operating cycle, acreage and lease information, and conservation compliance information. Additionally, applicants which are entities will be required to submit a list of owners, personal financial statements from the owners, and copies of the entities legal documents.

The FSA 440-32,“Statement of Debts and Collateral” form will no longer be required because several weeks often pass before creditors return them to FSA, thereby increasing the time required for determination of feasibility. Most of the information supplied by creditors on this form can be obtained by FSA from credit reports. The required use of the verification of employment form will also be eliminated. Employment, salary, and wage information is quickly and easily verified by credit reports, current payroll statements or IRS Forms W-2.

Certain recurring applicants requesting annual OL assistance will be required to submit a signed and dated FSA 410-1, a check or money order for credit report and lien filing fees, a Farm and Home Plan for the next operating cycle, and any information that has changed from the previous loan application, including acreage and lease information, and conservation compliance documentation.

For all applicants who apply under the Lo-Doc process, the Agency reserves the right to request additional information that would be required of a loan applicant under the normal process. The Agency will not require information beyond Lo-Doc requirements as a matter of course, but will request supporting documentation when information submitted deviates from local norms, conflicts with other available information, or otherwise creates the need for further documentation.

Lo-Doc applicants requesting a loan of $50,000 or less must meet current eligibility requirements for FSA direct OL's listed in section 1941.12. In addition, the applicant must be current on all loan payments to FSA and all other creditors, must not have received primary loan servicing or disaster set-aside on any FSA debt within the past 5 years, and must owe FSA less than $100,000, including the new loan. These additional requirements are necessary to sufficiently lower the risk from an FSA credit standpoint to make a sound credit decision based on the reduced documentation.

Lo-Doc applicants requesting a recurring annual OL assistance must meet all current eligibility requirements for FSA direct operating loans as listed in § 1941.12 and, must have at least 2 years of annual OL history with FSA where the loans were timely repaid, be current on payments to all other creditors, and have not received primary loan servicing or disaster set-aside on any FSA debt within the past 5 years.

Applicants who cannot meet the criteria for these new application procedures may receive a regular OL provided they meet the current requirements in § 1941.12.

Lo-Doc OL's for $50,000 or less can be used for any authorized operating expense allowed in § 1941.16, except paragraph (i) for refinancing debts. This limitation is necessary because the need for refinancing is an indication of financial stress and, thus, a greater credit risk than other OL loan purposes. The Agency must perform additional analysis on those cases to help borrowers become successful and better understand the risk associated with each request.

Lo-Doc OL's issued to recurring applicants requesting annual OL assistance can only be used for any authorized annual operating expense allowed in paragraphs (c) and (h) of § 1941.16. Because these applicants have demonstrated that they are good operators who have repaid their annual operating loans, the Agency is reducing the paperwork requirements for them to obtain subsequent annual operating credit. Also, if they want operating credit for purposes other than annual operating they may qualify for the Lo-Doc OL under $50,000 loan purposes. For applicants that do not qualify under either of the Lo-Doc programs, the Agency feels that there is sufficient risk to warrant the Agency's continued collection of the same application materials currently required.

On October 24, 2000 (65 FR 63750), the NRC published in the Federal Register a direct final rule amending its regulations to allow licensees to use any type of personnel dosimeter that is processed by an accredited NVLAP processor. In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become final on the date noted above. The NRC did not receive any comments that warranted withdrawal of this direct final rule. Therefore, this rule will become effective as scheduled.

On October 11, 2000 (65 FR 60339), the NRC published in the Federal Register a direct final rule amending its regulations in 10 CFR 72 on the HI-STAR 100 cask system in seven areas and includes changes to the Certificate of Compliance and Technical Specifications. The seven areas involve: revision of the existing fuel specification tables; addition of pressurized water reactor Burnable Poison Rod Assemblies and Thimble Plug Devices; addition of two new classes of fuel to the fuel specification tables; addition of a new damaged fuel container; addition of thoria rods in canisters; addition of antimony-beryllium neutron sources [i.e., reactor startup sources], and clarifications, editorial corrections, and other minor changes to cask design information and drawings. In addition, the amendment includes two minor changes to HI-STAR 100 listing in the regulations. In the direct final rule, NRC stated that if no significant adverse comments were received, the direct final rule would become final on the date noted above. The NRC did not receive any comments on the direct final rule. Therefore, this rule will become effective as scheduled.

Airworthiness Directive (AD) 2000-20-04, amendment 39-11915, applicable to certain McDonnell Douglas Model MD-90-30 series airplanes, was published in the Federal Register on October 6, 2000 (65 FR 59707). That AD requires replacement of certain ground block screws with new screws; and retermination of the circuit ground wires of the electrical power control unit (EPCU) to separate grounding points.

The background information on the IRR program, the relative need formula, the FHWA Price Trends Report, and the TEA-21 Negotiated Rulemaking process is detailed in the Federal Register Notice dated February 15, 2000 (65 FR 7431). You may obtain additional information on the IRR program web site at http://www.irr.bia.gov.

For fiscal year 2000 IRR program funds, the Secretary published two interim rules distributing one-half of the funds in February, 2000 and the second half of the funds in June, 2000. This distribution followed the TEA-21 Negotiated Rulemaking Committee's recommendation to the Secretary in January, 2000 to distribute fiscal year 2000 IRR program funds under the relative need formula used in 1998 and 1999 while continuing to develop alternative formulas for comment. In addition, we modified the Federal Highway Administration Price Trends Report indices to account for two non-reporting states.

The Transportation Equity Act for the 21st Century provides that the Secretary develop rules and a funding formula for fiscal year 2000 and subsequent fiscal years to implement the Indian Reservation Roads program section of the Act. The Negotiated Rulemaking Committee created under Section 1115 of TEA-21 and comprised of representatives of tribal governments and the federal government has been diligently working to develop a funding formula that addresses the Congressionally identified criteria, Committee and tribal recommendations, and is consistent with overall Federal Indian Policy.

Permanent funding formula options have been developed and agreed upon by the Committee and tribal representatives. These options will be published at a later date in the Federal Register for public comment. In the meantime, there are about 1400 ongoing road and bridge construction projects on or near Indian reservations which need fiscal year 2001 funding to continue or complete work. Partially constructed road and bridge projects could pose safety threats. Other road and bridge projects need to be planned or initiated in this fiscal year.

This rule is published as a temporary rule only for interim funding for fiscal year 2001 and sets no precedent for the final rule to be published as required by Section 1115 of TEA-21. The TEA-21 Negotiated Rulemaking Committee agrees that an interim funding formula for fiscal year 2001 is needed. The Committee expects to recommend the publication of two alternative formulas for public comment so that a final permanent formula can be established for the next fiscal year. The interim formula for fiscal year 2001 will also provide tribes with the critical resources to develop inventory data, long-range transportation plans, transportation improvement programs and other information necessary to distribute funds under a new funding formula to be put in place for fiscal year 2002 and thereafter.

The TEA-21 Negotiated Rulemaking Committee's tribal caucus recommended that the Secretary distribute fiscal year 2001 funds on the same basis as fiscal year 2000 funds, including a provision for an administrative capacity building set-aside. Under a special Congressional appropriation in fiscal year 2000, we distributed $18.3 million for transportation planning and the design of deficient IRR bridges.

Upon publication of this rule, the Secretary will distribute 75 percent (approximately $169.5 million) of fiscal year 2001 IRR program funds based on the current relative need formula used in fiscal year 2000, and the indices from the FHWA Price Trends Report with appropriate modifications for non-reporting states in the relative need formula distribution process. In this distribution we are reserving $19.53 million for federally recognized tribes who apply for and have negotiated contracts or agreements for up to $35,000 for administrative capacity building and other eligible transportation activities under the IRR program. Fiscal year 2001 funds will be distributed to the twelve BIA regions using this distribution process. The remaining 25 percent of fiscal year 2001 IRR program funds will be distributed under the same relative need formula as the first 75 percent of the funds, after comments are reviewed and any necessary changes to the distribution are made.

The following diagram shows the relationship between components for fiscal year 2001 IRR program funds distribution:

We are using the most current road inventory data (June 2000) maintained by the Bureau of Indian Affairs.

The primary purpose of administrative capacity building is to provide all tribes an opportunity to participate in the IRR program by updating transportation needs inventories and performing other transportation planning activities.

How Are We Distributing the Reserved Administrative Capacity Building Funds to the Twelve BIA Regions?

The administrative capacity building funds are to be reserved at the BIA Division of Transportation until the application/award deadline is met. We are distributing the reserved administrative capacity building funds ($19.53 million) to the twelve BIA regions based on the number of tribes in the region that request to participate by tribal resolution or other official action of the tribe.

Any Federally recognized tribe may apply to the appropriate BIA region for administrative capacity building funds under the Indian Self-Determination and Educational Assistance Act (P.L. 93-638) no later than March 15, 2001.

The BIA regions will provide administrative capacity building services to tribes in their regions that request such services.

A self-determination or self-governance tribe must make application to the appropriate BIA Region by March 15, 2001 and must include:

(a) Scope of work; and

(b) Detailed budget not to exceed $35,000; and

(c) Official tribal resolution or other official action of the tribe requesting the funds.

We will distribute the remaining funds to the twelve BIA regions based on the relative need formula discussed in this rule. It is important that each tribe submit its application for administrative capacity building within the established deadlines so that we can make a timely reallocation of any reserved funds that are not awarded by August 15, 2001.

The distribution of fiscal year 2001 IRR program funds are based on the current relative need formula and the FHWA Price Trends Report indices that were used for the adjusted FY 2000 distribution. On February 15, 2000 the Secretary partially distributed fiscal year 2000 IRR program funds using the relative need formula. In June, 2000, the Secretary distributed the remaining funds under the relative need formula by modifying the FHWA price trend report indices for two non-reporting states, Washington and Alaska, that impact tribes in those non-reporting states. We are using the same modification process for non-reporting states for distribution of fiscal year 2001 IRR program funds. We are partially distributing fiscal year 2001 IRR program funds upon publication of this rule (75 percent) and we will distribute the remaining 25 percent of the funds following the 30-day comment period. In the first partial distribution of fiscal year 2001 funds we are reserving $19.53 million for administrative capacity building. Any federally recognized tribe may apply for $35,000 for such activities.

Under 5 U.S.C. 553(b)(3)(B), notice and public procedure on the first partial distribution under this rule are impracticable, unnecessary, and contrary to the public interest. In addition, we have good cause for making this temporary rule for distribution of 75 percent of fiscal year IRR program funds effective immediately under 5 U.S.C. 553(d)(3). Notice and public procedure would be impracticable because of the urgent need to distribute 75 percent of fiscal year 2001 IRR program funds. Approximately 1400 road and bridge construction projects are at various phases that require additional funds this fiscal year to continue or complete work, including 196 deficient bridges and the construction of approximately 600 miles of roads. Fiscal year 2001 IRR program funds will be used to design, plan, and construct improvements (and, in some cases, to reconstruct bridges). Without this partial distribution of fiscal year 2001 funds, tribal and BIA IRR projects will be forced to cease activity, placing projects and jobs in jeopardy. Waiting for notice and comment on this temporary rule would be contrary to the public interest. In some of the BIA regions, approximately 80 percent of the roads in the IRR system (and the majority of the bridges) are designated school bus routes. Roads are essential access to schools, jobs, and medical services. Many of the priority tribal roads are also emergency evacuation routes and represent the only access to tribal lands. Two-thirds of the road miles in Indian country are unimproved roads. Deficient bridges and roads are health and safety hazards. Partially constructed road and bridge projects jeopardize the health and safety of the traveling public. Further, over 200 projects currently in progress are directly associated with environmental protection and preservation of historic and cultural properties. This temporary rule is going into effect immediately because of the urgent need for partially distributing fiscal year 2001 funds to continue these construction projects.

We are providing for a 30-day comment period upon publication of this temporary rule for comments on distribution of the remaining 25 percent of fiscal year 2001 IRR program funds. We will review and consider comments on distributing the remaining 25 percent of fiscal year 2001 IRR program funds before the second distribution.

Executive Order 12866 requires each agency to write regulations that are easy to understand. We invite your comments on how to make this temporary rule easier to understand, including answers to questions such as the following: (1) Are the requirements in the temporary rule clearly stated? (2) Does the temporary rule contain technical language or jargon that interferes with its clarity? (3) Does the format of the temporary rule (grouping and order of sections, paragraphing, etc.) aid or reduce its clarity? (4) Is the description of the temporary rule in the SUPPLEMENTARY INFORMATION section of the preamble helpful in understanding the temporary rule? What else could we do to make the temporary rule easier to understand?

Under the criteria in Executive Order 12866, this temporary rule is a significant regulatory action because it will have an annual effect of more than $100 million on the economy. The total amount available for distribution of fiscal year 2001 IRR program funds is approximately $226 million and we are distributing approximately $169.5 million under this temporary rule. Congress has already appropriated these funds and FHWA has already allocated them to BIA. The cost to the government of distributing the IRR program funds, especially under the relative need formula with which the tribal governments and tribal organizations and the BIA are already familiar, is negligible. The distribution of fiscal year 2001 IRR program funds does not require tribal governments and tribal organizations to expend any of their own funds.

This temporary rule is consistent with the policies and practices that currently guide our distribution of IRR program funds. This temporary rule continues to adopt the relative need formula that we have used since 1993, adjusting the FHWA Price Trends Report indices for states that do not have current data reports.

This temporary rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another Federal agency. The FHWA has transferred the IRR program funds to us and fully expects the BIA to distribute the funds according to a funding formula approved by the Secretary. This temporary rule does not alter the budgetary effects on any tribes from any previous or any future distribution of IRR program funds and does not alter entitlement, grants, user fees, or loan programs or the rights or obligations of their recipients.

This temporary rule does not raise novel legal or policy issues. It is based on the relative need formula in use since 1993. We are changing determination of relative need only by appropriately modifying the FHWA Price Trend Report indices for states that did not report data for the FHWA Price Trends Report, just as we did for the second partial distribution of fiscal year 2000 IRR program funds.

Approximately 1400 road and bridge construction projects are at various phases that depend on this fiscal year's IRR program funds. Leaving these ongoing projects unfunded will create undue hardship on tribes and tribal members. Lack of funding would also pose safety threats by leaving partially constructed road and bridge projects to jeopardize the health and safety of the traveling public. Thus, the benefits of this rule far outweigh the costs. This rule is consistent with the policies and practices that currently guide our distribution of IRR program funds. This rule continues to adopt the relative need formula that we have used since 1993.

A Regulatory Flexibility analysis under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) is not required for this temporary rule because it applies only to tribal governments, not State and local governments.

This rule is a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act, because it has an annual effect on the economy of $100 million or more. We are distributing approximately $169.5 million under this temporary rule. Congress has already appropriated these funds and FHWA has already allocated them to BIA. The cost to the government of distributing the IRR program funds, especially under the relative need formula with which tribal governments, tribal organizations, and the BIA are already familiar, is negligible. The distribution of the IRR program funds does not require tribal governments and tribal organizations to expend any of their own funds.

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. Actions under this rule will distribute Federal funds to Indian tribal governments and tribal organizations for transportation planning, road and bridge construction, and road improvements.

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. In fact, actions under this rule will provide a beneficial effect on employment through funding for construction jobs.

Under the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.), this temporary rule will not significantly or uniquely affect small governments, or the private sector. A Small Government Agency Plan is not required.

This temporary rule will not produce a federal mandate that may result in an expenditure by State, local, or tribal governments of $100 million or greater in any year. The effect of this temporary rule is to immediately provide 75 percent of fiscal year 2001 IRR program funds to tribal governments for ongoing IRR activities and construction projects.

With respect to Executive Order 12630, the rule does not have significant takings implications since it involves no transfer of title to any property. A takings implication assessment is not required.

With respect to Executive Order 13132, the rule does not have significant Federalism implications to warrant the preparation of a Federalism Assessment. This temporary rule should not affect the relationship between State and Federal governments because this rule concerns administration of a fund dedicated to IRR projects on or near Indian reservations that has no effect on Federal funding of state roads. Therefore, the rule has no Federalism effects within the meaning of Executive Order 13132.

This rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988. This rule contains no drafting errors or ambiguity and is clearly written to minimize litigation, provide clear standards, simplify procedures, and reduce burden. This rule does not preempt any statute. We are still pursuing the TEA-21 mandated negotiated rulemaking process. The rule is not retroactive with respect to any funding from any previous fiscal year (or prospective to funding from any future fiscal year), but applies only to 75 percent of fiscal year 2001 IRR program funding.

The Paperwork Reduction Act does not apply because this rule does not impose record keeping or information collection requirements or the collection 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. 501 et seq. We already have all of the necessary information to implement this rule.

This rule is categorically excluded from the preparation of an environmental assessment or an environmental impact statement under the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq. , because its environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and the road projects funded as a result of this rule will be subject later to the National Environmental Policy Act process, either collectively or case-by-case. Further, no extraordinary circumstances exist to require preparation of an environmental assessment or environmental impact statement.

In accordance with the President's memorandum of May 14, 1998, Consultation and Coordination with Indian Tribal Governments (63 FR 27655) and 512 DM 2, we have evaluated any potential effects upon federally recognized Indian tribes and have determined that this rule preserves the integrity and consistency of the relative need formula process we have used since 1993. The only changes we are making from previous years (which we also made for fiscal year 2000 IRR program funds (see Federal Register Notice 65 FR 7431)) are to modify the FHWA Price Trends Report indices for non-reporting states which do not have current price trends data reports. The yearly FHWA Report is used as part of the process to determine the cost-to-improve portion of the relative need formula. Consultation with tribal governments and tribal organizations is ongoing as part of the TEA-21 negotiated rulemaking process and this distribution uses the TEA-21 Negotiated Rulemaking Committee's tribal caucus recommendation.

On December 26, 1995, we published an advance notice of proposed rulemaking (ANPRM) entitled “Regattas and Marine Parades; Permit Application Procedures” in the Federal Register (60 FR 66773). On April 17, 1996, we published a notice of proposed rulemaking (NPRM) entitled “Regattas and Marine Parades” (61 FR 16732). On June 26, 1996, we published an interim rule with notice of availability of environmental assessment entitled “Regattas and Marine Parades” (61 FR 33027). As a result of a series of notices of delay of effective date, the interim rule never went into effect (61 FR 60027, November 26, 1996; 62 FR 67570, December 29, 1997; 63 FR 71753, December 30, 1998; and 64 FR 70184, December 16, 1999). No public hearing was requested, and none was held.

The original purpose for this rulemaking was to explore ways to better carry out our statutory responsibility, under 33 U.S.C. 1233, to promote safety of life on navigable waters during regattas and marine parades. In keeping with the President's Regulatory Reinvention Initiative, we reviewed the regulations on marine events in 33 CFR part 100 and determined that the regulations needed revising to eliminate overly burdensome, unnecessary, and obsolete requirements. To that end, this rulemaking intended to eliminate the need for Coast Guard marine event permits, unless a permit was necessary to advance the statutory purpose of promoting safety of life during marine events. The rule would have established various categories of marine events: those that did not require either a written notice to the Coast Guard or a Coast Guard permit because they clearly posed no extra or unusual hazard to the safety of life; those that required written notice to the Coast Guard because they may have posed such a hazard; and those that required an individual Coast Guard permit because they clearly posed such a hazard. For a detailed discussion of this project and our statutory authority, see the ANPRM, NPRM, and interim rule mentioned under “Regulatory History” in this preamble.

During the course of this project, we consulted with, and continue to consult with, other governmental agencies on the likely environmental effects of our proposals. As a result of the concerns of environmental agencies on the possible adverse effects of our proposals on the environment and, in particular, on endangered species, we have decided to withdraw this interim rule and close CGD 95-054. In its place, we plan to develop new alternatives through a new rulemaking project. In this new project, we will again address our original concerns of eliminating overly burdensome requirements on the sponsors of events, while being responsive to environmental issues.

This final rule amends 33 CFR 100.15 entitled “Submission of application.” Before this amendment, paragraph (c) of § 100.15 stated that an application to hold a proposed marine event must be submitted to the Coast Guard no less than 30 days before the start of the event. In § 100.17(c) of the interim rule, the 30-day period was increased to 135 days before the event or, if all of the following apply, to 60 days before the event:

(1) If the sponsor submitted an application for the event in the year immediately preceding.

(2) If the particulars of the event, such as its nature, location, and scheduling, are essentially the same as for the previous event.

(3) If the Coast Guard did not require a permit for the previous event.

In the final rule, we revised the 60-day criteria to reflect the current regulations on issuing permits for recurring events. To avoid potential burdens of an abrupt transition to the new regulation in paragraph (c), new paragraphs (d) and (e) of § 100.15 provide special lead times for events to be held within 196 days after the effective date of the final rule.

1. One comment to the interim rule stated that an extension of the existing 30-day deadline for submitting applications to 135 days is unnecessarily burdensome.

Since 1963, when the existing regulations were issued, the number of factors that are required to be considered in the permitting process have greatly increased. Additional statutes enacted since 1963 must now be considered before a permit is issued. For example, compliance with the National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) alone can delay approval of a permit for 120 days or more. Furthermore, while marine events have become larger, faster, and more frequent and have a greater impact on navigation, the Coast Guard's resources for processing permits have been reduced. The 135-day period is based on the minimum time needed for the Coast Guard to review the application and verify its contents; to consult with other agencies and allow time for their responses; to determine whether a special local regulation under 33 CFR 100.35 is needed and, if so, issue that regulation; to determine if changes to the application are needed; and to prepare the required environmental documentation.

For annually recurring events that meet certain specified criteria, the interim rule in § 100.17(c) and this final rule in § 100.15(c) provide for submitting an application a minimum of 60 days before the event.

2. One comment asked us to clarify when an event would be subject to the new rules. For example, what if the sponsor has met the 30-day minimum for requesting a permit under paragraph (c) of previous § 100.15 and, in the meantime, this final rule goes into effect, with its 135-day requirement in new § 100.15(c)? The new requirement could force the sponsor to cancel the event.

We agree that a transition period is needed. See new paragraphs (d) and (e) of § 100.15 in this final rule.

This final 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 the final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. The final rule increases the minimum amount of time necessary for the Coast Guard to process marine-event applications. This means that some sponsors of events may have to plan their events earlier. Though this increase may impose a burden on those sponsors, it is necessary to meet new statutory considerations affecting approval of applications and to allow agencies that must be consulted to have a reasonable amount of time to respond.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this final 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.

As discussed in the “Regulatory Evaluation” section of this preamble, the need for this rule is due to the increased review time needed to comply with statutes enacted after the previous regulation was issued, as well as to the increasing number of events held. The final rule applies to all marine-event sponsors, both large and small. Some sponsors may now find the need to plan events farther into the future than they have in the past, though having to plan farther into the future does not necessarily create an economic impact. However, to keep the lead-time to the minimum necessary, the final rule provides for a shorter lead-time for events that repeat annually and that meet the criteria listed in § 100.15(c). Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

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

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 final rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). This rule does not affect the content of, or burden of collecting information for, marine event application.

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their regulatory actions not specifically required by law. 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 final 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 final rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

We have considered the environmental impact of this final rule and concluded that, under figure 2-1, paragraph (34)(a), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. This rule is administrative in nature and concerns the timeframe for submitting an application. It will have no direct affect on the environment. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES .

The Rock Island Railroad and Highway Drawbridge provides a vertical clearance of 23.8 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This deviation has been coordinated with waterway users who do not object.

This deviation allows the bridge to remain closed-to-navigation from 7 a.m., January 1, 2001, to 7 a.m., February 26, 2001. The drawbridge normally opens on signal.

The Memorial bridge across the Gulf Intracoastal Waterway at Volusia County, Daytona Beach, is a double leaf bridge with a vertical clearance of 21 feet above mean high water (MHW) measured at the fenders in the closed position with a horizontal clearance of 90 feet. On November 28, 2000, Sieg and Ambachtsheer, Inc., contractors representing the drawbridge owner, requested a deviation from the current operating regulation in 33 CFR 117.5 which requires drawbridges to open promptly and fully when a request to open is given. This temporary deviation was requested to allow necessary repairs to the drawbridge in a critical, time-sensitive manner.

The District Commander has granted a temporary deviation from the operating requirements listed in 33 CFR 117.5 for the purpose of repair completion of the drawbridge. Under this deviation, the Memorial Bridge need only open one leaf from January 8, 2001 until January 19, 2001. The deviation is effective beginning January 8, 2001, to January 19, 2001.

The Cortez bridge across the Gulf Intracoastal Waterway at Sarasota County, Cortez, is a double leaf bridge with a vertical clearance of 25.5 feet above mean high water (MHW) measured at the fenders in the closed position with a horizontal clearance of 90 feet. On December 13, 2000, Florida Department of Transportation, the drawbridge owner, requested a deviation from the current operating regulation in 33 CFR 117.5 which requires drawbridge to open promptly and fully when a request to open is given. This temporary deviation was requested to allow necessary repairs to the drawbridge in a critical time sensitive manner.

The District Commander has granted a temporary deviation from the operating requirements listed in 33 CFR 117.35 for the purpose of repair completion of the drawbridge. Under this deviation, the Cortez Bridge need only open one leaf from 8 a.m. until 4 p.m. The deviation is effective for one day, on January 10, 2001.

The Siesta Key bridge across the Gulf Intracoastal Waterway at Sarasota County, has a vertical clearance of 21 feet above mean high water (MHW) measured at the fenders in the closed position with a horizontal clearance of 90 feet. On December 13, 2000, Florida Department of Transportation, the drawbridge owner, requested a deviation from the current operating regulation in 33 CFR 117.5 which requires drawbridge to open promptly and fully when a request to open is given. This temporary deviation was requested to allow necessary repairs to the drawbridge in a critical time sensitive manner.

The District Commander has granted a temporary deviation from the operating requirements listed in 33 CFR 117.5 for the purpose of repair completion of the drawbridge. Under this deviation, the Siesta Key Bridge need only open the east span from 8 a.m. until 12 p.m. on January 8, 2001.

We, the EPA, are approving ODEQ's air toxics program for non-part 70 sources and their mechanism for receiving future delegation of unchanged Federal NESHAP regulations for non-part 70 sources. The State submittal meets all section 112(l) requirements because:

• The State program is no less stringent than the Federal program. The ODEQ's rules at Oklahoma Administrative Code, subchapter 41, Control of Emissions of Hazardous and Toxic Air Contaminants, part 3, Hazardous Air Contaminants, section 252:100-41-15, adopt certain Federal NESHAP regulations by reference, as more fully discussed in this action.

• The ODEQ has demonstrated adequate authority and resources to implement and enforce the standards.

• The schedule for implementation and compliance is sufficiently expeditious.

• The program otherwise complies with Federal guidance.

A more detailed analysis of the State's submittal pursuant to § 63.91 is in the Technical Support Document included in the docket of this rulemaking. The mechanism for future delegation of unchanged standards is described in question twelve below.

We are delegating:

We are approving ODEQ's request for delegation of authority to implement and enforce specific 40 CFR parts 61 and 63, subparts for all sources, as they exist July 1, 1999. A notable exception is that we are not delegating those standards under part 61 dealing with radionuclides.

We are approving in part ODEQ's request for delegation of authority to implement and 40 CFR part 61, subpart A and part 63, subpart A, General Provisions (for all sources). The ODEQ's rules are unchanged from the Federal provisions.

We have determined that ODEQ has sufficient resources and expertise to implement certain sections of the General Provisions. A July 10, 1998, memorandum from John Seitz  1 clarified which of the part 63 General Provisions authorities may be delegated to State agencies. On September 14, 2000 our rules were revised to outline the delegable authorities at 40 CFR 63.91(g). A guidance document 2 from EPA's Office of Enforcement and Compliance clarified the part 61 discretionary authorities which were appropriate to delegate to State agencies. Granting ODEQ authority to make decisions that are not likely to be nationally significant or which do not alter the stringency of the underlying standard is in keeping with these authorities. The ODEQ should make decisions on a source-by-source basis, not on a source category basis.

Listed below are the part 61, subpart A, sections that we cannot delegate to ODEQ. We are delegating all other part 61, General Provision authorities to ODEQ.

For part 70 sources, semiannual and annual reports are required and this does not change that requirement. Decisions ODEQ makes, such as State applicability determinations, approval of alternatives to test methods, approval of alternatives to monitoring and approval of alternatives to recordkeeping requirements are not binding on EPA.

In 1982, the Administrator of EPA's Dallas Regional Office delegated some authority to implement and enforce New Source Performance Standards (NSPS) and NESHAPs to ODEQ. (47 FR 17285, April 22, 1982) These standards and authorities are found in 40 CFR parts 60 and 61, respectively. Today's action will rescind and replace the NESHAP portion of that agreement only. The NSPS portion of the 1982 delegation agreement as supplemented on October 8, 1999 is not affected by this rulemaking. This delegation will cover more part 61 standards, more sources, and grant more discretionary authority to ODEQ, as discussed in the General Provision section of this document.

Section 112(l) of the CAA enables EPA to approve State air toxics programs or rules to operate in place of the Federal air toxics program or rules. 40 CFR part 63, subpart E (65 FR 55810 September 14, 2000) governs EPA's approval of State rules or programs under section 112(l).

Approval of an air toxics program is granted by EPA if we find that:

(1) The State program is “no less stringent” than the corresponding Federal program or rule,

(2) The State has adequate authority and resources to implement the program,

(3) The schedule for implementation and compliance is sufficiently expeditious, and

(4) The program otherwise complies with Federal guidance. Any request for subpart E approval that does not change the Federal section 112 rules must meet the criteria in 40 CFR 63.91.

The request may specify the mechanism that the State will use in the future to receive delegation of unchanged Federal section 112 standards without additional Federal rulemaking.

The procedure and criteria for requesting and receiving approval of programs or requesting delegation under section 112(l) of the CAA was initially published on November 26, 1993 in 58 FR 62262. The regulations were codified at 40 CFR part 63, subpart E. The EPA's procedures for delegating NESHAPS were modified on September 14, 2000 in 65 FR 55810. The revisions were to provide more options and expedite the approval process. These revisions did not affect the criteria and procedures for program approval and straight delegation to Oklahoma, and the State's request and our review is consistent with the regulations as revised.

With this delegation, ODEQ has the primary responsibility to implement and enforce the delegated standards.

This action does not apply to areas of Indian Country over which the State of Oklahoma has not demonstrated authority. States do not have jurisdiction over Indian Country (as defined in 18 U.S.C. 1151, and referenced in 40 CFR 51.1(i)) unless specifically granted by Congress. Since the State of Oklahoma has not submitted a demonstration of authority over the Indian Country, we are limiting our approval to those areas that do not constitute Indian Country. For a more detailed discussion of Tribal authority under the Act, see 59 FR 43956, August 25, 1994 and 63 FR 7254, February 12, 1998.

We retain the right, as allowed by CAA section 112(l)(7), to enforce any applicable emission standard or requirement under section 112.

The EPA Administrator has the authority to approve certain changes to, or make decisions under the General Provisions to parts 61 and 63. This authority is in 40 CFR part 61, subpart A and 40 CFR part 63, subpart A. We are granting ODEQ some of these authorities, and retaining others, as explained with the General Provisions description. And as stated earlier, EPA is not bound by State determinations.

In addition, no authorities are delegated that require rulemaking in the Federal Register to implement, or where Federal overview is the only way to ensure national consistency in the application of the standards or requirements of CAA section 112.

Also, we retain any authority in an individual emission standard that may not be delegated according to provisions of the standard.

The EPA must oversee ODEQ's decisions to ensure the delegated authorities are being adequately implemented and enforced. We will integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place.

If, during oversight, we determine that ODEQ made decisions that decreased the stringency of the delegated standards, then ODEQ should take corrective actions and the source(s) affected by the decisions would be notified. We will initiate withdrawal of the program if the corrective actions taken are insufficient.

On March 10, 1995, we proposed to approve the State's program and mechanism for gaining delegation of unchanged section 112 standards for part 70 sources (60 FR 13092). This was included in our proposal to approve ODEQ's request for interim approval of the part 70 Operating Permit Program. On February 5, 1996, we issued final approval of the State's air toxics program and delegation mechanism for all section 112 standards under the authority of CAA section 112(1)(5) and 40 CFR 63.91 (61 FR 4224). This applies only to sources covered by the part 70 program.

We received delegation requests from ODEQ dated June 26, 1998, and May 5, 2000. These requests are for delegation of the 40 CFR parts 61 and 63 NESHAP standards adopted unchanged into Oklahoma Administrative Code Title 252 Chapter 100 Air Pollution Control Subchapter 41 Control of Emission of Hazardous and Toxic Air Contaminants. The ODEQ requested delegation of the general provisions and emission standards listed in the tables below. These requests were made according to the requirements of 40 CFR part 63, subpart E. 58 FR 62262, November 26, 1993. This regulation, which governs EPA's approval of State rules or programs was recently revised to better serve the needs of State and Local agencies that want to implement NESHAPs in their areas. 65 FR 55810, September 14, 2000. These revisions did not affect the criteria and procedures for program approval and straight delegation to Oklahoma, and the State's request and our review is consistent with the regulations as revised.

The State has asked for delegation of these standards, and we are delegating them to ODEQ, as they existed on July 1, 1999. Please see question twelve below for a discussion of how we will delegate future standards and revisions to the State.

Certain General Provisions authorities are automatically granted to ODEQ as part of their part 70 Operating Permits Program approval (regardless of whether the Operating Permits Program approval is interim or final). These are 40 CFR 63.6(i)(1), “Extension of Compliance with Emission Standards,” and 63.5(e) and (f), “Approval and Disapproval of Construction and Reconstruction.” 3

Additionally, ODEQ's authority to grant a source a compliance extension under 40 CFR 63.6(i)(1) is not limited to delegated standards or part 70 permitted sources.

Sources within ODEQ's jurisdiction must submit notifications and reports required by the delegated NESHAPs to ODEQ, and sources do not need to send a copy to EPA. The ODEQ is the primary point of contact with respect to delegated NESHAPs. EPA Region 6 waives the requirement that notifications and reports for delegated standards be submitted to EPA in addition to ODEQ per 40 CFR 63.9(a)(4)(ii) and 63.10(a)(4)(ii).

In delegating the authority to implement and enforce these rules and in granting a waiver of EPA notification requirements, we require ODEQ to input all source information into the Aerometric Information Retrieval System (AIRS) for both point and area sources. The ODEQ must enter this information into the AIRS system and update the information by September 30 of every year. Additionally, ODEQ must also report to EPA, Region 6, all MACTRAX information on our request, which is typically semiannually. (MACTRAX provides summary data for each implemented NESHAP that EPA uses to evaluate the Air Toxics Program.) The ODEQ must provide any additional compliance related information to EPA, Region 6, Office of Compliance Assurance as necessary.

In receiving delegation for specific General Provisions authorities, ODEQ must submit to EPA, Region 6, copies of determinations issued under these authorities. For part 61, these determinations include: applicability determinations (section 61.01); determinations of construction or modification (section 61.06); approvals of construction or modification (section 61.08); Waiver of Compliance (section 61.11); Operation and Maintenance Requirements (section 61.12(c)); Waiver of Emission Test (section 61.13(h)(1)(iii) and (i)(1), (2)); Approval of Minor Alternatives to Monitoring (section 61.14(g) except section 61.14(g)(1)(ii)). For part 63, these determinations include: applicability determinations (§ 63.1); approval/disapprovals of construction and reconstruction (§ 63.5(e) and (f)); approval/disapprovals of compliance extensions (§ 63.6(i)(1)); approval of shorter sampling times and volumes (§ 63.7(e)(2)(iii)); waiver of performance testing (§ 63.7(e)(2)(iv) and (h)(2), (3)); approval of adjustments to time periods for submitting reports (§§ 63.9 and 63.10); approvals/disapprovals of minor (§ 63.7(e)(2)(i)) or intermediate (§ 63.7(e)(2)(ii) and (f)) alternative test methods; approvals/disapprovals of minor or intermediate alternative monitoring methods (§ 63.8(f)); and approvals/disapprovals of minor alternatives to recordkeeping and reporting (§ 63.10(f)). The ODEQ must also forward to EPA, Region 6, copies of any notifications received under § 63.6(h)(7)(ii) regarding the use of a continuous opacity monitoring system.

Additionally, EPA's Emission Measurement Center of the Emissions Monitoring and Analysis Division must receive copies of any approved intermediate changes to test methods or monitoring. (Please note that intermediate changes to test methods must be demonstrated as equivalent through the procedures set out in EPA method 301.) This information on approved intermediate changes to test methods and monitoring will be used to compile a database of decisions that will be accessible to State and local agencies and EPA Regions for reference in making future decisions. (For definitions of major, intermediate and minor alternative test methods or monitoring methods, see 40 CFR 63.90). The ODEQ should forward these intermediate test methods or monitoring changes via mail or facsimile to: Chief, Source Categorization Group A, U.S. EPA (MD-19), Research Triangle Park, NC 27711, Facsimile telephone number: (919) 541-1039.

In the future, for all sources, ODEQ will only need to send a letter of request to EPA, Region 6, for those NESHAP regulations that the State has adopted by reference with proof of its regulatory authority. We will respond in writing to the request stating that the request for delegation is either granted or denied. If a request is approved, the effective date of the delegation will be the date of our response letter. A document of the delegation will be published in the Federal Register to inform the public and affected sources of the delegation and to indicate where source notifications and reports should be sent.

Furthermore, ODEQ intends to update their adoptions by reference of 40 CFR parts 61 and 63 standards and request updated delegation annually, as current standards are revised and new standards are promulgated.

As part of today's rule, we are delegating, under the CAA, implementation and enforcement authority for the Hazardous Waste Combustor MACT to ODEQ. Many of the sources subject to the HWC MACT are also subject to the RCRA permitting requirements. We expect air emissions and related operating requirements found in the HWC MACT will be included in part 70 permits issued by ODEQ. However, RCRA permits will still be required for all other aspects of the combustion unit and the facility that are governed by RCRA ( e.g., corrective action, general facility standards, other combustor-specific concerns such as materials handling, risk-based emissions limits and operating requirements, as appropriate and other hazardous waste management units). 4 See the HWC MACT rule preamble discussion on the interrelationship of the MACT rule with the RCRA Omnibus provision and site specific risk assessments at 64 FR 52828, pages 52839-52843, September 30, 1999, and the RCRA Site-Specific Risk Assessment Policy for Hazardous Waste Combustion Facilities dated June, 2000 for more information.

The public was provided the opportunity to comment on the proposed approval of the program and mechanism for delegation of section 112 standards, as apply to part 70 sources, on March 10, 1995. 60 FR 13088. The EPA received public comments on that proposal and responded to them in the February 5, 1996, Federal Register . 61 FR 4220. In this action, the public is given an opportunity to comment on the program and mechanism for the State to gain delegation of these standards as they apply to non-part 70 sources. However, the Agency views the approval of these requests as a noncontroversial action and anticipates no adverse comments. Therefore, EPA is publishing this rule without prior proposal. However, in the Proposed Rules section of today's Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the program and delegation of authority described in this action if adverse comments are received. This action will be effective March 9, 2001 without further notice unless the Agency receives relevant adverse comments by February 7, 2001.

If EPA receives adverse comments, we will publish a timely withdrawal in the Federal Register informing the public the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

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

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

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

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Federalism (64 Federal Register 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. The EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a State program and rules implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Thus, Executive Order 13132 does not apply to this rule. Although section 6 of the Executive Order does not apply to this rule, EPA did consult with State officials in developing this rule, and this rule is in response to the State's delegation request.

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

This rule will not have a significant impact on a substantial number of small entities because delegation of authority to implement and enforce unchanged Federal standards under section 112(l) of the CAA does not create any new requirements, but simply transfers primary implementation authorities to the State. Therefore, because this action does not impose any new requirements, the Administrator certifies that this action will not have a significant economic impact on a substantial number of small entities.

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

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

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

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

This rule does not involve special consideration of Environmental Justice related issues as required by Executive Order 12898 (59 FR 7629, February 16,1994).

As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.

The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney Generals Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective March 12, 2001 unless EPA receives adverse written comments by February 8, 2001.

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 12, 2001. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-301097. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for residues of the insecticide spinosad, in or on the following commodities: alfalfa, forage at 4.0 parts per million (ppm); alfalfa, hay at 4.0 ppm; beet, sugar at 0.020 ppm; beet, sugar, tops at 10.0 ppm; beet, sugar, molasses at 0.250 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; peanut at 0.020 ppm; and peanut, hay at 10.0 ppm.

Furthermore, tolerances for livestock commodities are being modified, on a time-limited basis, as follows: meat of cattle, horses, goats, hogs, and sheep from 0.15 to 0.60 ppm; fat of cattle, horses, goats, hogs, and sheep from 3.5 to 15.0 ppm; meat byproducts (mbyp) of cattle, horses, goats, hogs, and sheep from 1.0 ppm to 3.50 ppm; milk, whole from 0.5 to 2.0 ppm; milk, fat from 5.0 ppm to 20.0 ppm; eggs from 0.02 to 0.030 ppm; and poultry, fat from 0.2 ppm to 0.30 ppm. These tolerances will expire and are revoked on December 31, 2002. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

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

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

The states of Texas, New Mexico, Kansas and Oklahoma all requested the use of spinosad to control an emergency situation with the beet armyworm on alfalfa. The states of Texas and New Mexico requested the use of spinosad to control an emergency situation with the beet armyworm in peanuts. The state of California requested the use of spinosad on sugar beets to control armyworms, and the state of Arkansas requested the use of spinosad to control armyworms in pastureland and rangeland. EPA has authorized under FIFRA section 18 the use of spinosad on alfalfa in Texas, New Mexico, Kansas, and Oklahoma to control the beet armyworm; on peanuts in Texas and in New Mexico to control the beet armyworm; on sugar beets in California to control armyworms; and on pastureland and rangeland in Arkansas for control of armyworms. After having reviewed the submissions, EPA concurs that emergency conditions exist for these states.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of spinosad in or on alfalfa, peanuts, sugar beets and pastureland and rangeland. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemptions in order to address urgent non-routine situations and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on December 31, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on alfalfa forage, alfalfa hay, sugar beets, sugar beet tops, sugar beet molasses, grass forage, grass hay, peanuts, peanut hay and the modified livestock commodity tolerances after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether spinosad meets EPA's registration requirements for use on many or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of spinosad by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any States other than Texas, New Mexico, Kansas and Oklahoma for alfalfa; Texas and New Mexico for peanuts; California for sugarbeets; or Arkansas for pastureland and rangeland to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for spinosad, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of spinosad and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for residues of spinosad in or on alfalfa, forage at 4.0 ppm; alfalfa, hay at 4.0 ppm; beet, sugar at 0.020 ppm; beet, sugar, tops at 10.0 ppm; beet, sugar, molasses at 0.250 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; peanut at 0.020 ppm; and peanut, hay at 10.0 ppm, as well as the modified tolerances for livestock commodities as follows: meat of cattle, horses, goats, hogs, and sheep from 0.15 to 0.60 ppm; fat of cattle, horses, goats, hogs, and sheep from 3.5 to 15.0 ppm; meat byproducts of cattle, horses, goats, hogs, and sheep from 1.0 ppm to 3.50 ppm; milk, whole from 0.5 to 2.0 ppm; milk, fat from 5.0 ppm to 20.0 ppm; eggs from 0.02 to 0.03 ppm; and poultry, fat from 0.2 ppm to 0.30 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows.

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for spinosad used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.495) for the residues of spinosad, in or on a variety of raw agricultural commodities. Tolerances range from 0.02 ppm (many commodities; limit of quantitation) to 20 ppm (aspirated grain fractions). Risk assessments were conducted by EPA to assess dietary exposures from spinosad in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. An acute dietary exposure risk assessment is not required because the Agency did not identify an acute dietary endpoint that was applicable to females (13+ years) or to the general population, including infants and children.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. Tolerance level residues were used for all commodities with the exception of the following: anticipated residues were used for the livestock feed commodities from alfalfa, peanuts, pastures and rangeland, and sugar beets. This Tier 2 DEEM analysis shows that dietary (food only) exposure estimates are below the Agency's level of concern for all population subgroups. The highest chronic dietary exposure was for children 1-6 years old at 0.015291 mg/kg/day, representing 57% of the chronic PAD (cPAD). Exposure for the U.S. population was 0.007679 mg/kg/day, representing 28% of the cPAD.

iii. Cancer . No cancer endpoints were identified, and thus a cancer risk assessment is not required.

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

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

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

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

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

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of spinosad for chronic exposures are estimated to be 0.057 parts per billion (ppb) for surface water and 0.006 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

No acute dietary, cancer, short-term, intermediate-term, or chronic dermal or inhalation endpoints were identified by the Agency. Spinosad is currently registered on turf grass, creating a potential for non-dietary oral exposure to children who ingest grass. To calculate a quantitative dietary risk from a potential ingestion of grass (in the absence of acute-, short-, or intermediate-term oral endpoints), the Agency would need to default to the chronic dietary endpoint. This scenario would represent a child eating grass for > 6 months continuously. Based on the low application rate for spinosad on turf (0.41 lbs.ai./A.), its non-systemic nature, its short half-life (especially in sunlight), and the rapid incorporation of spinosad metabolites into the general carbon pool, the Agency believes that residues of spinosad on turf grass after application would be low and decrease rapidly over time. The Agency believes that it is inappropriate to perform a quantitative dietary risk representing a chronic scenario from children eating spinosad residues on turf grass. Qualitatively, the risk from children eating spinosad residues on turf grass does not exceed the Agency's level of concern.

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

EPA does not have, at this time, available data to determine whether spinosad has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, spinosad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that spinosad has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

2. Developmental toxicity studies . There were no developmental effects that could be attributed to administration of spinosad technical to either rats or rabbits. The NOAEL for developmental toxicity is greater than or equal to 200 mg/kg/day (highest dose tested) for rats and greater than or equal to 50 mg/kg/day (highest dose tested) for rabbits.

3. Reproductive toxicity study . The LOAEL for reproductive toxicity is 100 mg/kg/day based on both maternal and reproductive effects in rats including decreases in litter size, survival (F2 litters only), and body weights in the offspring, and increased incidence of dystocia and/or vaginal bleeding after parturition with associated increases in mortality in the dams. The NOAEL for reproductive (offspring and dams) and systemic (parental) toxicity is the same and is 10 mg/kg/day.

4. Conclusion . There is a complete toxicity data base for spinosad and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency has removed the 10x Safety Factor to account for enhanced sensitivity of infants and children based on (i) the completeness of the toxicological database, (ii) no indication of increased susceptibility of rat or rabbit fetuses to in utero and/or postnatal exposure, and (iii) no requirement for a developmental neurotoxicity study.

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

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

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

1. Acute risk . No acute toxicological endpoint was identified by the Agency, and therefore this risk assessment is not required.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to spinosad from food will utilize 28% of the cPAD for the U.S. population, 25% of the cPAD for all infants and 57% of the cPAD for children 1-6 years of age. Although spinosad is currently registered on turf grass, creating a potential for non-dietary oral exposure to children who ingest grass, the Agency believes that it is inappropriate to perform a quantitative dietary risk representing a chronic scenario from children eating spinosad residues on turf grass. Qualitatively, the risk from children eating spinosad residues on turf grass does not exceed the Agency's level of concern. In addition, despite the potential for chronic dietary exposure to spinosad in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of spinosad in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Though residential exposure could occur with the use of spinosad, no toxicological effects have been identified for short-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level).

Though residential exposure could occur with the use of spinosad, no toxicological effects have been identified for intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

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

Adequate high performance liquid chromatography using ultra violet detection and immunoassay methods exist to enforce tolerances for residues of spinosad in/on plant and animal matrices. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no Codex, Canadian, or Mexican maximum residue levels (MRLs) established for spinosad. There are no international residue limits that affect this Section 18 exemption.

Therefore, the tolerance is established for residues of spinosad in or on alfalfa, forage at 4.0 ppm; alfalfa, hay at 4.0 ppm; beet, sugar at 0.020 ppm; beet, sugar, tops at 10.0 ppm; beet, sugar, molasses at 0.250 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; peanut at 0.020 ppm; and peanut, hay at 10.0 ppm. Furthermore, tolerances for livestock commodities are being modified, on a time-limited basis, as follows: meat of cattle, horses, goats, hogs, and sheep from 0.15 to 0.60 ppm; fat of cattle, horses, goats, hogs, and sheep from 3.5 to 15.0 ppm; meat byproducts of cattle, horses, goats, hogs, and sheep from 1.0 ppm to 3.50 ppm; milk, whole from 0.5 to 2.0 ppm; milk, fat from 5.0 ppm to 20.0 ppm; eggs from 0.02 to 0.03 ppm; and poultry, fat from 0.2 ppm to 0.30 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301097 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before March 12, 2001.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by the docket control number OPP-301097 to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes time limited tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under FFDCA section 408, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

In FR Doc. 00-8215 of April 7, 2000 (65 FR 18434), there were several typographical errors. The provisions in this document are effective as if they had been included in the document published in the Federal Register on April 7, 2000.

In FR Doc. 00-8215 on April 7, 2000 (65 FR 18434), make the following corrections:

On page 18434, column 1, in the Dates section, “§ 412.24(d)(6)” is corrected to read “§ 413.24(d)(6)”, “§ 489.24(h)” is corrected to read “§ 489.24”.

The modified Base Flood Elevations are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified Base Flood Elevation determinations are available for inspection is provided.

Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified base flood elevations are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified elevations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

The changes in Base Flood Elevations are in accordance with 44 CFR 65.4.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Associate Director for Mitigation certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

Regulatory Classification. This interim rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

All sea turtles that occur in U.S. waters are listed as either endangered or threatened under the Endangered Species Act of 1973 (ESA). The Kemp's ridley ( Lepidochelys kempii ), leatherback ( Dermochelys coriacea ), and hawksbill ( Eretmochelys imbricata ) are listed as endangered. Loggerhead ( Caretta caretta ) and green ( Chelonia mydas ) turtles are listed as threatened, except for breeding populations of green turtles in Florida and on the Pacific coast of Mexico, which are listed as endangered.

The incidental take and mortality of these species as a result of shrimp trawling activities has been documented in the Gulf of Mexico and along the Atlantic seaboard. Under the ESA and its implementing regulations, taking sea turtles is prohibited, with exceptions identified in 50 CFR 223.206. Existing sea turtle conservation regulations (50 CFR 223.206 and 223.207) require most shrimp trawlers operating in the Gulf and Atlantic Areas, defined at 50 CFR 222.102, to have a NMFS-approved TED installed in each net rigged for fishing, year- round. TEDs currently approved by NMFS for shrimp trawling include single-grid hard TEDs and hooped hard TEDs conforming to a generic description, and two types of special hard TEDs. One type of soft TED-the Parker soft TED - was approved through October 13, 2000.

NMFS approved the Parker TED for use in the waters of the Atlantic and Gulf Areas of the United States through an interim final rule (63 FR 17948, April 13, 1998). The interim final rule was set to expire on October 13, 1999. At that time, NMFS determined that while there was sufficient information on the use and effectiveness of the Parker TED to continue to allow its use, there was insufficient information to permanently approve it. Also, industry expressed interest in the testing for approval of variations of the Parker soft TED design. Therefore, NMFS extended its approval for 1 year (64 FR 55434, October 13, 1999), to allow time for the collection of additional data on the use and effectiveness of the Parker TED and to allow time for the shrimp industry to tests new soft TED designs. The extension expired on October 13, 2000.

NMFS looked at many aspects of the Parker soft TED’s performance over the past 30 months in both the Gulf of Mexico and the South Atlantic. Observers placed aboard commercial trawlers have documented sea turtle capture rates and finfish bycatch reduction. Intensive law enforcement efforts have ensured and documented compliance with the technical requirements for using the Parker TED. NMFS' gear specialists provided initial training to net shops and trawler fleets in the proper installation and use of the Parker TED. Follow-up assistance was also provided to fishermen and net makers as they adapted to using the new soft TED.

NMFS' observer information generally shows that the rate of sea turtle capture in the Parker soft TED is comparable to hard TEDs. In 1997-1998 in the southeastern Atlantic, observers documented three turtle captures in nets equipped with Parker TEDs. A total of 190 tows were observed, for 515 hours of trawling. The resulting turtle catch rate (“Catch per unit effort,” or “CPUE”) was 0.005 turtles per 100 ft (30.5 m) headrope-hour. During the same time period, observers documented 1 turtle capture in nets equipped with hard TEDs. A total of 62 tows were observed, for 161 hours of trawling, for a CPUE of 0.005 turtles per 100 ft (30.5 m) headrope-hour. Observations in the Gulf of Mexico revealed a similar situation, although turtle catch rates in the Gulf are much lower overall. In 1998, no turtle captures were documented by observers in 133 tows using Parker TEDs, totaling 1,352 hours of trawling. During the same time period, 2 turtle captures were documented by observers in nets equipped with hard TEDs. A total of 2,081 tows were observed, for a total of 9,632 hours of trawling, representing a CPUE of 0.0001. All of these observed catch rates for shrimp trawlers using hard TEDs and Parker TEDs are small and it is therefore difficult to make definitive comparisons.

Shrimp loss in the Parker TED was also a concern, therefore observer data was collected to test the Parker TED’s reliability catching shrimp. Observer data from the Gulf and South Atlantic Fisheries Development Foundation and South Carolina Department of Natural Resources showed that nets equipped with a Parker TED experienced an 11.9 and 8.4 percent reduction in shrimp catch, respectively, compared to a hard TED-equipped net.

The Protected Resources Enforcement Team (PRET) is a specially-equipped team of NMFS law enforcement officers that focus enforcement attention on protected resources issues primarily TEDs- in the southeastern United States. In 1998, the PRET’s first year in operation, the team logged 488 hours of at-sea patrols, boarding 261 vessels as part of the TED compliance project. PRET boardings in 1998 focused on nearshore shrimping grounds along the coasts of Texas, Louisiana, Georgia, and South Carolina. A large portion of the PRET’s efforts in 1999 had been dedicated to patrols along the Texas coast, due to the continuing concern over the number of dead sea turtles that strand on Texas beaches. From March 16, 1999, through August 19, 1999, the PRET boarded 241 vessels along the Texas and Louisiana coasts.

Enforcement efforts in the South Atlantic prior to October 1999 also indicated that use of the Parker TED in the shrimp fleet was very low. The PRET only encountered one trawler equipped with Parker TEDs during 53 boardings in 1998. NMFS gear specialists accompanied SCDNR enforcement officers on patrols of state waters during May 1999. Out of approximately 40 trawlers boarded at sea, two were using Parker soft TEDs. The U.S. Coast Guard Group in Charleston, SC reported encountering only a total of 4 boats with Parker TEDs over the prior 2 years. No violations were reported from these seven boardings.

Since October 13, 1999, the PRET has concentrated their patrols in the Gulf of Mexico, where there was virtually no Parker soft TED use. The Parker TED is currently being used more in the Atlantic than in the Gulf, but even in the Atlantic the use is low (less than 50 boats). The Atlantic shrimping fleet is routinely inspected for TED compliance by the U.S. Coast Guard, state natural resources agency marine patrols, and NMFS law enforcement agents. No Parker TED violations have been documented in the Atlantic. While exact statistics on the numbers of inspections are not available, law enforcement agencies have found that the compliance rate on the boats that do use the Parker TED is good.

During 1998 and 1999, industry representatives expressed an interest in the testing for approving of Parker TED variations. NMFS issued the required testing permits to industry but there have been no new developments in Parker TED design reported by industry. Therefore, NMFS has no new Parker TED variations to approve and is approving only the version of the Parker TED previously approved.

The installation specifications for the Parker TED included an unprecedented level of technical detail compared to our previous soft TED regulations. The specifications included new requirements such as limiting installation to only certain styles of nets, exact mesh counts for fixing the location of the soft TED panel in the net, and detailed sewing instructions for attaching the panel to the net. As discussed in the April 13, 1998, interim final rule (63 FR 17948), NMFS believes that this level of technical specificity is required for the Parker TED to achieve a proper shape and exclude turtles effectively.

NMFS provided intensive technical training to assist the shrimp industry to adopt these stringent technical requirements. During 1998 and 1999, NMFS gear specialists held training sessions throughout the southeastern United States to improve TED technical operation and compliance. Technical assistance included the development of improved training and educational materials which were distributed through the Coast Guard, Sea Grant and through TED skill building workshops. Workshops included multimedia presentations and hands-on instruction which were highly effective in transferring technical information. TED operational manuals were distributed to assist fishermen in complying with TED regulations and assist in solving TED operational problems. In spring 1998, the training specifically focused on net shops around the entire Atlantic and Gulf coasts. Training sessions included a review of the Parker TED regulatory requirements and included hands-on training for installing Parker TEDs. Generally, net makers did not experience difficulty with the technical installation requirements for the Parker TED; however, NMFS’ gear specialists provided follow-up visits to work with net makers requiring further assistance. During the Spring of 1999, NMFS gear specialists visited net shops along the Texas coast to provide follow-up Parker TED training if necessary, but found no net shops still making Parker TEDs in Texas. In the Atlantic, NMFS’ gear specialists confirmed that only one net shop in each state (Florida, Georgia, South Carolina, and North Carolina) was still installing Parker TEDs in 2000. Those shops reported no ongoing technical problems.

NMFS’ gear specialists held workshops to train Federal and state law enforcement personnel in the technical installation requirements for the Parker soft TED. NMFS’ gear specialists also accompanied federal and state law enforcement personnel during at-sea and dockside boardings to provide hands-on technical training and to collect information on TED technical performance and compliance. This assistance was provided in North Carolina, South Carolina, Georgia, Florida, Alabama, Louisiana, and Texas.

During the period May-July 1999, 3 NMFS gear specialists provided 22 days of assistance to fishermen in North Carolina, South Carolina and Georgia in modifying their TEDs to comply with the leatherback turtle contingency plan (60 FR 47713, September 14, 1995). Although almost all fishermen used hard TEDs with a large escape opening to comply with the leatherback contingency plan, the gear specialists found 10 vessels in McClellanville, South Carolina, that were equipped with Parker TEDs, modified to use the leatherback escape opening. The fishermen reported little difficulty in successfully making the leatherback modification to their Parker TEDs.

We received no comments on the October 13, 1999, extension of interim final rule that extended the approved use of the Parker soft TED. Comments received on the April 13, 1998 interim final rule (63 FR 17948) were responded to in the October 13, 1999, extension to that interim rule (64 FR 55434).

It was NMFS’ intention to make its approval of the Parker TED permanent before the 1-year extension of its approval expired on October 13, 2000. However, because of an inadvertent administrative delay, NMFS was not able to do this before the approval expired. This final rule permanently approves the Parker TED for use in the waters of the Atlantic and Gulf Areas of the United States. This final rule makes no changes to the technical requirements for the Parker TED nor to the restrictions on the styles of net in which it may be installed.

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

Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator for Fisheries, NOAA, (AA) finds that there is good cause to waive providing prior notice and opportunity for public comment for this rule. It would be contrary to the public interest to delay this rule to provide prior notice and an opportunity for public comment because the delay would deprive fishermen from using a TED determined by NMFS as meeting the criteria for approval and whose approval had expired because of administrative delay. Without such delay, the previous approval could have been made permanent without a waiver, because providing prior notice and opportunity for public comment would not have been required. Finally providing an opportunity for public comment is unnecessary given the public's opportunity to comment on the original approval rule (63 FR 17948, April 13, 1998; 64 FR 55434, October 13, 1999).

Because this final rule does not create any new regulatory burden, but instead relieves regulatory restrictions by allowing an additional option for complying with existing sea turtle conservation requirements, under 5 U.S.C. 553(d)(1) it is not subject to a 30-day delay in effective date.

Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , are inapplicable.

The AA prepared an Environmental Assessment/Regulatory Impact Review (EA/RIR) for the April 13, 1998, interim final rule (63 FR 17948) that approved the use of the Parker TED through October 13, 2000. The EA/RIR concluded that the rule will have no significant impact on the human environment. An EA/RIR, prepared for this final rule, concluded that the permanent use of the Parker soft TED will have no significant impact on the human environment. A copy of the EA/RIR is available (see ADDRESSES ).

Endangered and threatened species, Exports, Imports, Marine mammals, Transportation.