This action is being taken under the provisions of section 8c(16)(A) of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act,” and §§ 911.49(b) and 911.64(d) of Marketing Order No. 911, regulating the handling of limes grown in Florida, hereinafter referred to as the “order.”

This final rule is also issued under section 8e of the Act, which provides that whenever certain specified commodities, including limes, are regulated under a Federal marketing order, imports of these commodities into the United States are prohibited unless they meet the same or comparable grade, size, quality, or maturity requirements as those in effect for the domestically produced commodities.

USDA is issuing this rule in conformance with Executive Order 12866.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 8c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of import regulations issued under section 8e of the Act.

This rule terminates the marketing order covering Florida limes and the rules and regulations established under the order.

The order has been in effect since 1955. It authorizes the establishment of grade, size, quality, pack, and container requirements, although such requirements have not been in effect since February 2002. The order also authorizes production and marketing research and development. The program is funded by assessments imposed on lime handlers.

Section 911.64(d) of the order specifies that continuance referenda must be conducted among lime producers every sixth year before March 31. Therefore, during the period from September 9 to September 28, 2002, USDA conducted a referendum among lime growers to determine if they favored continuation of their program. The referendum order provided that USDA would consider terminating the provisions of the order if less than two-thirds of the number of growers voting and growers of less than two-thirds of the lime volume represented in the referendum favored continuance.

Ballots were mailed to 54 known lime growers in Florida. By the close of the voting period, 11 valid votes had been cast. The results show that 18.2 percent of the growers voting, who produced 57.73 percent of the volume represented in the referendum, favored continuation of the program. The order failed to pass either criteria for continuance, demonstrating a lack of producer support needed to carry out the objectives of the Act. In addition, effective February 19, 2002 (67 FR 6837), grade, size, quality, maturity, pack, inspection, assessment collection, reporting, and other requirements prescribed under the order as specified in §§ 911.110, 911.120, 911.130, 911.131, 911.234, 911.311, 911.329, and 911.344 were suspended. Thus, it has been determined that the provisions of the order no longer tend to effectuate the declared policy of the Act.

Therefore, pursuant to section 8c(16)(A) of the Act and § 911.64 of the order, it has been found that the order provisions should be terminated. Section 8c(16)(A) of the Act requires USDA to notify Congress at least 60 days before terminating a Federal marketing order program. Congress was so notified on November 6, 2002.

Pursuant to § 911.65 of the order, the members of the Lime Administrative Committee shall serve as trustees to conclude and liquidate the affairs of the committee.

Section 8e of the Act provides that whenever certain specified commodities, including limes, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, size, quality, and maturity requirements as those in effect for the domestically produced commodities. Since this rule terminates the lime marketing order for domestically produced limes and the resultant rules and regulations, a corresponding change to the import regulations must also be made.

In addition, effective February 19, 2002 (67 FR 6837), grade, size, quality, maturity, pack, inspection, assessment collection, reporting, and other requirements prescribed under the order as specified in §§ 911.110, 911.120, 911.130, 911.131, 911.234, 911.311, 911.329, and 911.344 were suspended.

Consequently, this rule removes § 944.209.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility. Import regulations issued under the Act are based on those established under Federal marketing orders.

There are approximately 54 producers of limes in the production area and approximately 6 handlers subject to regulation under the marketing order. In addition, approximately 240 importers of limes are subject to import regulations and will be impacted by this termination. Small agricultural producers are defined as those having annual receipts of less than $750,000, and small agricultural service firms, which include handlers and importers, are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $5,000,000.

The average f.o.b. price for fresh limes during the 2000-01 season was around $14.75 per bushel and total shipments were 344,032 bushels for the season. Using this price and total volume for the season, all lime handlers could be considered small businesses under the SBA definition. The majority of Florida lime producers may also be classified as small entities.

In calendar year 2000, imports of limes totaled 9.7 million bushels. Assuming the same average f.o.b. price as for Florida limes, the average importer receives gross receipts of about $600,000. Thus, the majority of lime importers can be classified as small entities.

This final rule terminates the marketing order covering limes grown in Florida, the rules and regulations established under the order, and the requirements for limes imported into the United States that are shipped to the fresh market. USDA has determined the order should be terminated. In a recent referendum, growers indicated that they did not support the continuance of the program.

This action eliminates program requirements imposed on lime handlers and importers. Minimum grade, size, maturity and quality requirements for limes imported into the United States are effective under § 944.209 (7 CFR 944.209). As this rule terminates the marketing order for limes and the corresponding regulations, the import regulations for limes imported into the United States are also terminated. All regulations were previously suspended effective February 19, 2002.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection requirements being terminated by this rule were approved previously by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0189. Termination of the order is expected to reduce the total annual reporting burden on Florida lime handlers by a total of 73.98 burden hours.

USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this final rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

In accordance with section 8e of the Act, the United States Trade Representative has concurred with the issuance of this final rule.

After consideration of all relevant matter presented, including the results of a recently held producer referendum, it is hereby found that the lime marketing order and the rules and regulations in effect under the order do not tend to effectuate the declared policy of the Act and, therefore, are terminated.

It is further found that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice, and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register (5 U.S.C. 553) because: (1) This action relieves restrictions on handlers and importers by terminating the requirements of the lime marketing order and the lime import regulations; (2) handlers were given notice of this action in a widely distributed press release issued on November 5, 2002; (3) a final rule was published in the Federal Register on February 14, 2002, suspending all regulations from February 19, 2002 through February 24, 2003; and (4) no useful purpose would be served by delaying the effective date.

This rule is issued under Marketing Agreement and Order No. 984, both as amended, (7 CFR part 984), regulating the handling of walnuts grown in California, hereinafter referred to as the “order.” The marketing agreement and order are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

USDA is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California walnut handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable walnuts beginning on August 1, 2002, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule continues to decrease the assessment rate established for the Board for the 2002-03 and subsequent marketing years from $0.0124 to $0.0120 per kernelweight pound of assessable walnuts.

The California Walnut marketing order provides authority for the Board, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Board are producers and handlers of California walnuts. They are familiar with the Board's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2001-02 and subsequent marketing years, the Board recommended, and USDA approved, an assessment rate of $0.0124 per kernelweight pound of assessable walnuts that would continue in effect from year to year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Board or other information available to USDA.

The Board met on September 13, 2002, and unanimously recommended 2002-03 expenditures of $2,970,000 and an assessment rate of $0.0120 per kernelweight pound of assessable walnuts. In comparison, last year's budgeted expenditures were $3,124,800. The assessment rate is $0.0004 lower than the $0.0124 rate previously in effect. The lower assessment rate is necessary because this year's crop is estimated by the California Agricultural Statistics Service (CASS) to be 275,000 tons (247,500,000 kernelweight pounds merchantable), and the budget is about 5 percent less than last year's budget. Thus, sufficient income should be generated at the lower rate for the Board to meet its anticipated expenses.

Major categories in the budget recommended by the Board for the 2002-03 year include $2,438,403 for program expenses, including marketing and production research projects, $333,100 for employee expenses such as administrative and office salaries, payroll tax and benefits, $80,500 for office expenses, $79,500 for other operating expenses, and $38,497 as a reserve for a contingency. Budgeted expenses for these items in 2001-02 were $2,566,569 for program expenses including marketing and production research projects, $313,200 for employee expenses, $130,600 for office expenses, $76,000 for other operating expenses, and $38,431 as a reserve for a contingency.

The assessment rate recommended by the Board was derived by dividing anticipated expenses by expected shipments of California walnuts certified as merchantable. Merchantable shipments for the year are estimated at 247,500,000 kernelweight pounds which should provide $2,970,000 in assessment income and allow the Board to cover its expenses. Unexpended funds may be used temporarily to defray expenses of the subsequent marketing year, but must be made available to the handlers from whom collected within 5 months after the end of the year, according to § 984.69.

The assessment rate will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and other information submitted by the Board or other available information.

Although this assessment rate is effective for an indefinite period, the Board will continue to meet prior to or during each marketing year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Board meetings are available from the Board or USDA. Board meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Board recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Board's 2002-03 budget has been reviewed and approved by USDA. Those for subsequent marketing years will also be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 5,800 producers of walnuts in the production area and about 43 handlers subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those having annual receipts of less than $5,000,000.

Current industry information shows that 14 of the 43 handlers (32.5 percent) shipped over $5,000,000 of merchantable walnuts and could be considered large handlers by the Small Business Administration. Twenty-nine of the 43 walnut handlers (67.5 percent) shipped under $5,000,000 of merchantable walnuts and could be considered small handlers. An estimated 58 walnut producers, or about 1 percent of the 5,800 total producers, would be considered large producers with annual income over $750,000. Based on the foregoing, it can be concluded that the majority of California walnut handlers and producers may be classified as small entities.

This rule continues to decrease the assessment rate established for the Board and collected from handlers for the 2002-03 and subsequent marketing years from $0.0124 to $0.0120 per kernelweight pound of assessable walnuts. The Board unanimously recommended 2002-03 expenditures of $2,970,000. The assessment rate should generate sufficient income to meet the Board's 2002-03 anticipated expenses. The lower assessment rate is due to a reduced budget that is about 5 percent less than last year's budget.

Major categories in the budget recommended by the Board for the 2002-03 year include $2,438,403 for program expenses, including marketing and production research projects, $333,100 for employee expenses such as administrative and office salaries, payroll tax and benefits, $80,500 for office expenses, $79,500 for other operating expenses, and $38,497 as a reserve for a contingency. Budgeted expenses for these items in 2001-02 were $2,566,569 for program expenses including marketing and production research projects, $313,200 for employee expenses, $130,600 for office expenses, $76,000 for other operating expenses, and $38,431 as a reserve for a contingency.

Prior to arriving at this budget, the Board considered information from various sources, such as the Board's Budget and Personnel Committee, Research Committee, and Marketing Development Committee. Alternative expenditure levels were discussed by these groups, based upon the relative value of various research projects to the walnut industry. The recommended $0.0120 per kernelweight pound assessment rate was then determined by dividing the total recommended budget by the 247,500,000 kernelweight pound estimate of assessable walnuts for the year. Unexpended funds may be used temporarily to defray expenses of the subsequent marketing year, but must be made available to the handlers from whom collected within 5 months after the end of the year according to § 984.69.

A review of historical information and preliminary information pertaining to the current marketing year indicates that the grower price for 2002-03 could range between $0.50 and $0.70 per kernelweight pound of assessable walnuts. Therefore, the estimated assessment revenue for the 2002-03 year as a percentage of total grower revenue could range between 1.7 and 2.5 percent.

This action continues to decrease the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers. In addition, the Board's meeting was widely publicized throughout the walnut industry and all interested persons were invited to attend the meeting and participate in Board deliberations on all issues. Like all Board meetings, the September 13, 2002, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

This action imposes no additional reporting or recordkeeping requirements on either small or large California walnut handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

An interim final rule concerning this action was published in the Federal Register on November 21, 2002 (67 FR 70146). Copies of that rule were also mailed or sent via facsimile to all walnut handlers. Finally, the interim final rule was made available through the Internet by the Office of the Federal Register and USDA. A 60-day comment period was provided for interested persons to respond to the interim final rule. The comment period ended on January 21, 2003, and no comments were received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Board and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

The Homeland Security Act of 2002, as amended, (“HSA”) transfers the functions of the Immigration and Naturalization Service (“Service” or “INS”) to the Department of Homeland Security (“DHS”). Public Law 107-296, title IV, subtitles D, E, F, 116 Stat. 2135, 2192 (Nov. 25, 2002), as amended (“HSA”). The HSA retains in the Department of Justice, under the direction of the Attorney General, the functions of the Executive Office for Immigration Review (“EOIR”) and other law determination and litigation functions. HSA, 116 Stat. at 2273. This rule reflects technical amendments to citations in 8 CFR chapter V.

Changes to section citations to sections within the same part of chapter V have already been accomplished in the rule published February 28, 2003. This rule sets out the tables of citation changes for citations to sections in other parts of both chapters I and V. Where appropriate, the changes are made to the conformed sections of chapter V, but there are instances where the conformed section and specific paragraph cite to authority that does not related to functions that will remain in the Department of Justice. Accordingly, these citations are changed to refer to the appropriate section of chapter I of this part as it is being transferred to the Department of Homeland Security. For example, authority of the Service that is contained in chapter I often requires a change in chapter V to eliminate “in this chapter” language and refer directly to the Service's authority “in chapter I.” This is consistent with the Department of Justice long range plan in eliminating unnecessary duplication of provisions between chapter I and chapter V.

The Department of Justice finds that good cause exists for adopting this rule as a final rule and without public notice and comment under 5 U.S.C. 553 because this rule only makes technical amendments to the organization, procedures, and practices of the Department of Justice to improve the organization of the regulations of the Department of Justice and reflects the transfer of functions contemplated by the Homeland Security Act of 2002. Similarly, because this final rule makes only technical changes in cross-references in existing regulations, this final rule is not subject to the effective date limitation of 5 U.S.C. 553(d).

Because no notice of proposed rule-making is required for this rule under the Administrative Procedure Act (5 U.S.C. 553), the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

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

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

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

This rule has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulation. The Department has determined that this rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review.

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

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

Bovine tuberculosis (tuberculosis) is a contagious, infectious, and communicable disease caused by Mycobacterium bovis. It affects cattle, bison, deer, elk, goats, and other warm-blooded species, including humans. Tuberculosis in infected animals and humans manifests itself in lesions of the lung, bone, and other body parts, causes weight loss and general debilitation, and can be fatal. At the beginning of the past century, tuberculosis caused more losses of livestock than all other livestock diseases combined. This prompted the establishment of the National Cooperative State/Federal Bovine Tuberculosis Eradication Program for tuberculosis in livestock. Through this program, the Animal and Plant Health Inspection Service (APHIS) works cooperatively with the national livestock industry and State animal health agencies to eradicate tuberculosis from domestic livestock in the United States and prevent its recurrence.

Federal regulations implementing this program are contained in 9 CFR part 77, “Tuberculosis” and in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” January 22, 1999, edition, which is incorporated by reference into the regulations in part 77. Additionally, the regulations in 9 CFR part 50 (referred to below as the regulations) provide for the payment of indemnity to owners of certain animals destroyed because of tuberculosis, in order to encourage destruction of animals that are infected with, or at significant risk of being infected with, the disease.

In an interim rule effective and published in the Federal Register on July 26, 2002 (57 FR 48745-48752, Docket No. 00-105-1), we amended the regulations in part 50 by providing that APHIS will make payments to owners of dairy cattle and other property used in connection with a dairy business and a dairy processing plant in the area of El Paso, TX, provided the owners agreed to dispose of their herds, close their existing dairy operations, and refrain from establishing new cattle breeding operations in the area. The interim rule was necessary to further tuberculosis eradication efforts in the United States and protect livestock not affected with bovine tuberculosis from the disease.

Comments on the interim rule were required to be received on or before September 24, 2002. We did not receive any comments by that date. However, we are making one change to the interim rule. One condition of eligibility for payment for dairy cattle was that each owner agree to cease operations within the described area and dispose of all sexually intact cattle on the dairy operation premises no later than 2 years after eligible owners signed their respective agreements. We have learned from representatives of dairy cattle owners affected by the interim rule that 2 years is an insufficient amount of time to dispose of all of their cattle through market channels. Therefore, we are amending the regulations to provide that owners of dairy cattle and other property in the described area must cease all dairy cattle operations and dispose of all sexually intact cattle on the dairy operations premises no later than 3 years after all eligible owners sign their respective agreements.

Therefore, for the reasons given in the interim rule and in this document, we are adopting the interim rule as a final rule, with the change discussed in this document.

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

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

Current regulations in 10 CFR Part 40 and 10 CFR part 150 require each NRC and Agreement State materials licensee to maintain an updated inventory of its holdings of source material of foreign origin ( e.g. , thorium, depleted uranium, and natural uranium mined outside the U.S.). Licensees are required to submit a report to the NRC whenever they receive or transfer source material of foreign origin. Some licensees are also required to submit an annual statement detailing their inventory of such material. Information in these reports is entered into a national nuclear materials database called the Nuclear Materials Management and Safeguards System (NMMSS). The NMMSS, managed jointly by the NRC and the Department of Energy (DOE), is the U.S. Government's official computerized accounting system for the possession, use, and shipment of nuclear materials (primarily special nuclear material and source material) in the U.S., whether of foreign or domestic origin.

The U.S. Government uses data in the NMMSS to meet its source material reporting requirements under a number of international agreements promoting global cooperation in the peaceful uses of nuclear energy. U.S. participation in international Agreements for Peaceful Nuclear Cooperation is provided for in Section 123 of the Atomic Energy Act, and approximately 24 such Agreements are in place and active at this time. Under these Agreements, the U.S. Government is obliged to impose controls on the use of certain nuclear materials, ensure that such materials are used only for peaceful ends, and enforce other conditions placed on the import, export, or transfer of specific equipment and nuclear material. As part of an information exchange required by the Agreements, the U.S. Government periodically provides to the governments of cooperating countries an updated inventory of certain nuclear material held in the U.S. To enable the U.S. Government to meet this obligation, the NRC must ensure that licensees document movement within the U.S. of nuclear material subject to these Agreements, and track any additional nuclear material produced through the use of that material.

As noted, existing NRC regulations require licensees to track and report their holdings of source material of foreign origin, i.e. , source material mined outside the U.S. However, under the Agreements for Peaceful Nuclear Cooperation to which it is a party, the U.S. Government is required to report a different range of source material. The NRC's current reporting requirements, which focus on the national origin of source material, no longer adequately serve this purpose. The aim of this rulemaking is to align the NRC's source material reporting requirements for licensees with international reporting requirements agreed to by the U.S. Government. The new requirements will require licensees to track and report source material which the U.S. Government is obliged to report under existing international agreements.

The amended regulation will replace requirements that licensee holdings of foreign-origin source material be reported to the NRC with requirements that licensees track and report source material with foreign obligations. Source material with foreign obligations (or foreign-obligated source material) is nuclear material that the U.S. is obliged to track, control, and report to foreign governments under existing international agreements. Requiring NRC licensees to track and report foreign-obligated source material will result in a database that is more robust and that will better satisfy the U.S. Government's need for specific information on source materials with foreign obligations. Part 110 was revised in 2000 to require importers and exporters to report on license applications the foreign obligations associated with nuclear material being imported or exported (65 FR 70287; November 22, 2000).

A change has also been made to the timing of the yearly statement required for source material with a foreign obligation, providing licensees with increased flexibility. Licensees are given a choice of submitting their annual inventory statements either at the same time as they submit the material status reports on special nuclear material that are required under Parts 72 and 74, or within 30 days after September 30th of each year, as is currently required.

In addition, a change is made to require reporting for any Agreement State licensee who exports one kilogram or more of uranium or thorium source material. The current regulations only require licensees that import such material to report. This information is needed because the U.S. Government is required to report all exports of source material of 1 kg or more to the International Atomic Energy Agency (IAEA). Part 40 already contains this requirement.

Finally, to clarify the scope of this amendment, parts 40 and 150 will define the term “foreign obligations” for use in those parts to mean “the commitments entered into by the U.S. Government under Atomic Energy Act (AEA) section 123 agreements for cooperation in the peaceful uses of atomic energy. Imports and exports of material or equipment pursuant to such agreements are subject to these commitments, which in some cases involve an exchange of information on imports, exports, retransfers with foreign governments, peaceful end-use assurances, and other conditions placed on the transfer of the material or equipment. The U.S. Government informs the licensee of obligations attached to material.” This definition is consistent with the definition of “obligations” in part 110.

This section is revised to add a definition of “foreign obligations.”

This section is revised to reflect a change from a requirement to report source material of foreign origin to reporting source material with foreign obligations. This section is also revised to allow licensees to submit their yearly inventory statement of source material with foreign obligations with their material status reports on special nuclear material, providing more flexibility to licensees.

This section is revised to add a definition of “foreign obligations.” In addition, the format of this section is updated to conform to current Office of the Federal Register standards for the listing of definitions in 10 CFR Chapter 1. The paragraph designations are removed and the definitions in the section are presented in alphabetical order.

This section is revised to reflect a change from a requirement to report source material of foreign origin to reporting source material with foreign obligations. This section is also revised to require the reporting of exports of 1 kilogram or more of source material. This amendment makes Part 150 consistent with Part 40, which already requires the reporting of such exports. In addition, this section is revised to allow licensees to submit their yearly inventory statement of source material with foreign obligations with the licensee's material status reports on special nuclear material, providing more flexibility to licensees.

Because the NRC considers this action to be noncontroversial and because it is necessary in order to support the U.S. Government's obligations in this area, the NRC is using the direct final rule process for this rule. The amendments to the rule will become effective on October 1, 2003. However, if the NRC receives significant adverse comments on this direct final rule by April 4, 2003, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published elsewhere in this Federal Register . Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the staff to make a change (other than editorial) to the rule.

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of Title 10 of the Code of Federal Regulations. Although an Agreement State may not adopt program elements reserved to NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws but does not confer regulatory authority on the State.

The Presidential Memorandum dated June 1, 1998, entitled, “Plain Language in Government Writing” directed that the Government's writing be in plain language. The NRC requests comments on this direct final rule specifically with respect to the clarity and effectiveness of the language used. Comments should be sent to the address listed under the heading ADDRESSES above.

The National Technology Transfer Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC is revising the reporting requirements for source material, using as the basis of the requirement whether the material has foreign obligations rather than the foreign origin of the material. This action does not constitute the establishment of a standard that establishes generally applicable requirements.

The NRC has determined that this direct final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(1), (c)(2), and (c)(3); therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this direct final rule.

This direct final rule decreases the burden on licensees to report the transfer, import, or export of foreign origin source material (NRC Form 741, OMB Approval Number 3150-0003) by reducing the number of responses by 855 for an annual burden reduction of 641 hours (855 responses × 0.75 hrs per response). Because the burden for this direct final rule is insignificant, Office of Management and Budget (OMB) clearance is not required. Existing requirements were approved by the Office of Management and Budget, approval numbers 3150-0020, -0032, and -003.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection request unless the requesting document displays a currently valid OMB control number.

A regulatory analysis has not been prepared for this regulation. The information reported is necessary to satisfy U.S. Government obligations under nuclear agreements for cooperation. Because not all foreign origin source material has associated foreign obligations, the rule may result in an insignificant decrease in regulatory burden on licensees. DOE/NRC Form-741 is used for the Nuclear Material Transaction Reports required by Parts 40 and 150. Approximately 36,500 DOE/NRC Form-741s are filed each year. Two NRC licensees submit the majority of the reports documenting the transfer, import, or export of foreign origin source material. These licensees have indicated that approximately 855 fewer reports will be required if the reporting requirement is changed to report only foreign obligation source material. The burden associated with each report is 0.75 hours for a total burden reduction of 641 hours.

The U.S. Government is required to report to IAEA the export of 1 kg or more of source material. The inclusion of Agreement State licensee reporting requirements for exports of 1 kg or more of source material should result in an insignificant increase in regulatory burden to licensees. Based on current information for the last 6 years, only 1 Agreement State licensee has exported source material of 1 kg or more. This licensee actually submitted a DOE/NRC Form-741 for its exports.

In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule does not have a significant economic impact on a substantial number of small entities. This rule is necessary to reflect the nuclear non-proliferation policies of the Executive branch and U.S. Government obligations under nuclear agreements for cooperation.

The NRC has determined that the backfit rule (§§ 50.109, 70.76, 72.62, or 76.76) does not apply to this direct final rule because this amendment does not involve any provisions that would impose backfits as defined in 10 CFR chapter I. Therefore, a backfit analysis is not required.

In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

The FAA has determined that notice and opportunity for prior public comment are impracticable because these procedures would significantly delay certification of the airplane and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance; however, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.

If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On July 10, 2002, Avcon Industries, Inc., P.O. Box 748, Newton, Kansas 67144, applied for a supplemental type certificate (STC) to modify Learjet Model 24/25 series airplanes. These models are currently approved under Type Certificate No. A10CE. The Learjet model 24 series airplanes have two aft-mounted General Electric Turbojet engines, a maximum operating altitude of 45,000 feet, and carries a crew of two with a maximum of six passengers. The Learjet model 25 series airplanes have two aft-mounted General Electric Turbojet engines, a maximum operating altitude of 51,000 feet, and carries a crew of two with a maximum of eight passengers. The modification incorporates the installation of dual Innovative Solutions and Support, Inc. (IS&S) Air Data Display Units (ADDU) and a single IS&S Analog Interface Unit (AIU) that are replacements for the existing altimetry system. The dual IS&S ADDU and a single IS&S AIU system use electronics to a far greater extent than the original altimetry system and may be more susceptible to electrical and magnetic interference caused by high-intensity radiated fields (HIRF) external to the airplane. This disruption of these signals could result in loss of altitude, or present misleading information to the pilot.

Under the provisions of 14 CFR 21.101, Amendment 21-69, effective September 16, 1992, Avcon Industries, Inc., must show that the Learjet Model 24/25 series airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A10CE, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The certification basis for the Learjet Model 24/25 Series airplanes includes § 21.29; 14 CFR part 25 effective February 1, 1965, as amended by Amendments 25-2 and 25-4. Other applicable amendments, regulations, and special conditions are noted in Type Certificate Data Sheet (TCDS) A10CE.

If the Administrator finds that the applicable airworthiness regulations (that is, part 25, as amended) do not contain adequate or appropriate safety standards for the Learjet Model 24/25 series airplanes because of novel or unusual design features, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Learjet Model 24/25 series airplanes must comply with the fuel vent and exhaust emission requirement of 14 CFR part 34 and the noise certification requirement of 14 CFR part 36.

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38, and become part of the type certification basis in accordance with § 21.101(b)(2), Amendment 21-69, effective September 16, 1991.

Special conditions are initially applicable to the model for which they are issued. Should Avcon Industries, Inc., apply at a later date for a supplemental type certificate to modify any other model already included on Type Certificate Data Sheet (TCDS) A10CE to incorporate the same or similar novel or unusual design features, these special conditions would also apply to the other model under the provisions of § 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

The Learjet Model 24/25 Series airplanes modified by Avcon Industries, Inc., will incorporate installation of dual IS&S Air Data Display Units (ADDU), and a single IS&S Analog Interface Unit (AIU) that will perform critical functions. These advanced systems use electronics to a far greater extent than the original altimetry system and may be vulnerable to high-intensity radiated fields (HIRF) external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects of HIRF. Accordingly, these systems are considered to be novel or unusual design features.

There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Learjet Model 24/25 series airplanes, modified by Avcon Industries, Inc. These special conditions require that new sensitive avionics/electronics and electrical systems that perform critical functions, be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

With the trend toward increased power levels from ground-based transmitters, and the advent of space and satellite communications, coupled with electronic command and control of the airplane, the immunity of critical digital avionics/electronics and electrical systems to HIRF must be established.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1 or 2 below:

1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 KHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the field strengths identified in the table below for the frequency ranges indicated. Both peak and average field strength components from the table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to Learjet Model 24/25 series airplanes modified by Avcon Industries, Inc. Should Avcon Industries, Inc., apply at a later date for a supplemental type certificate to modify any other model already included on Type Certificate A10CE to incorporate the same novel or unusual design features, these special conditions would apply to that model as well under the provisions of § 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

This action affects only certain novel or unusual design features on Learjet Model 24/25 series airplanes modified by Avcon Industries, Inc. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of the special conditions for this airplane has been subjected to notice and comment procedure in several prior instances and has been derived without substantive change from those previously issued. Because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

This amendment to 14 CFR 71 modifies the Class D airspace, the Class E airspace designated as an extension to a Class D or Class E surface area and the Class E airspace area extending upward from 700 feet or more above the surface of the earth at Dubuque, IA. An examination of controlled airspace for Dubuque, IA revealed discrepancies in the Dubuque Regional Airport, IA airport reference point used in the legal descriptions for these airspace areas. This amendment incorporates the revised Dubuque Regional Airport, IA airport reference point and brings the legal descriptions of these airspace areas into compliance with FAA Order 7400.2E, Procedures for Handling Airspace Matters. The areas will be depicted on appropriate aeronautical charts. Class D airspace areas are published in Paragraph 5000 of FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. Class E airspace designated as an extension to a Class D or Class E surface area and Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraphs 6004 and 6005, respectively, of the same FAA Order. The Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2003-14463/Airspace Docket No. 03-ACE-16.” The postcard will be date/time stamped and returned to the commenter.

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

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On Monday, December 2, 2002, the FAA proposed to amend 14 CFR part 71 to establish Class E airspace at Moundridge, KS. The proposal was to establish controlled airspace extending upward from 700 feet AGL to protect aircraft executing instrument approaches to Moundridge Municipal Airport. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005, of FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class E airspace at Moundridge, KS. Controlled airspace extending upward from 700 feet above the surface of the earth is needed to contain aircraft executing instrument approach procedures at Moundridge Municipal Airport. The area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The Class E airspace listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

•  Crop production (NAICS 111)

•  Animal production (NAICS 112)

•  Food manufacturing (NAICS 311)

•  Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0036. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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

In the Federal Register of March 14, 2002 (67 FR 11480) (FRL-6826-3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (1E6325) by the Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petition prepared by Gowan Company, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.448 be amended by establishing a tolerance for combined residues of the miticide, hexythiazox, trans-5-(4-chlorophenyl)- N -cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the 4-chlorophenyl-4-methyl-2-oxo-3-thiazolidine moiety in or on date, dried fruit at 1.0 parts per million (ppm).

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for combined residues of hexythiazox on date, dried fruit at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by hexythiazox and the endpoints use in risk assessment are discussed in Unit III. A. and B. of the final rule on hexythiazox pesticide tolerances published in the Federal Register of April 18, 2001 (66 FR 19879) (FRL-6778-8). Please refer to this document should you desire detailed toxicological information on hexythiazox.

The Agency has identified an acute dietary endpoint for females 13 years and older. The acute population adjusted dose (aPAD) for females is 2.4 milligrams/kilograms/day (mg/kg/day). No acute dietary endpoint was identified for the general population including infants and children; a dose and endpoint attributable to a single exposure were not identified from the available oral toxicity studies, including maternal toxicity in the developmental toxicity studies. The chronic population adjusted dose (cPAD) for all populations is 0.025 mg/kg/day. Hexythiazox has been classified as a category C, possible human carcinogen, for cancer. The calculated Q* for hexythiazox is 2.22 x 10 -2 .

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.448) for the combined residues of hexythiazox, trans-5-(4-chlorophenyl)- N -cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the 4-chlorophenyl-4-methyl-2-oxo-3-thiazolidine moiety in or on a variety of raw agricultural commodities (RAC) including tolerances for milk, fat, and meat byproducts of cattle, goat, horse, sheep, and swine. Risk assessments were conducted by EPA to assess dietary exposures from hexythiazox in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The dietary exposure evaluation model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the Department of Agriculture (USDA) 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Default processing factors were used, and 100 percent crop treated (PCT) information for all commodities.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A partially-refined dietary analysis was performed using anticipated residue levels for most crops (calculated from field trial data) and PCT or anticipated market-share information for all crops.

iii. Cancer . A partially-refined dietary-exposure analysis was performed using anticipated residue (AR) levels for most crops, processing factors where applicable, and PCT or anticipated market share information for all crops.

iv. Anticipated residue and PCT information . Section 408(b)(2)(E) of the FFDCA 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) of the FFDCA, EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

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

The following Table 1 provides a summary of the anticipated residue (AR) and PCT information used for the chronic and cancer exposure assessments. The Agency has issued emergency exemptions to the state of California for use of hexythiazox on dates since 1998. The PCT information for dates is based on applications made under these emergency exemptions. The majority of dates grown in the United States are grown in California.

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

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

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 percent reference dose (%RfD) or percent population adjusted dose (%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 hexythiazox they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the EECs of hexythiazox for acute exposures are estimated to be 1.81 parts per billion (ppb) for surface water and 0.009 ppb for ground water. The EECs for chronic exposures are estimated to be 0.91 ppb for surface water and 0.009 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). Hexythiazox is not registered for use on any sites that would result in residential exposure.

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

EPA does not have, at this time, available data to determine whether hexythiazox 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, hexythiazox 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 hexythiazox 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).

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

The prenatal and postnatal toxicology data base for hexythiazox is complete with respect to FQPA considerations. The nature of the toxic effects caused by hexythiazox are discussed in Unit III. D. of the final rule on hexythiazox pesticide tolerances published in the Federal Register of April 18, 2001 (66 FR 19879) (FRL-6778-8). Please refer to this document should you desire detailed toxicological information on hexythiazox regarding FQPA considerations.

The results of the prenatal and postnatal toxicology studies indicated no increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to hexythiazox. There is a complete toxicity data base for hexythiazox and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed and reduced to 1X. The FQPA factor is removed because an additional safety factor is not needed to protect the safety of infants and children.

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) = chronic (cPAD) − (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

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

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

1. Acute risk . An acute dietary endpoint has only been identified for females (13 years and older). Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to hexythiazox will occupy less than 1% of the aPAD for females 13 years and older. In addition, there is potential for acute dietary exposure to hexythiazox in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to hexythiazox from food will utilize less than 1% of the cPAD for the U.S. population and all infants and children subpopulations. There are no residential uses for hexythiazox. There is potential for chronic dietary exposure to hexythiazox in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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

4. Aggregate cancer risk for U.S. population . Hexythiazox has been classified as a Category C possible human carcinogen (Q 1 * = 2.22 x 10 -2 ). Using the exposure assumptions discussed in this unit for cancer, the carcinogenic risk estimate from food for the general U.S. population is 2.5 x 10 -7 . There is potential for chronic dietary exposure to hexythiazox in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the estimated cancer risk for aggregate exposure to exceed 1 x 10 -6 as shown in the following Table 4:

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 hexythiazox residues.

The high-performance liquid chromatography/ultraviolet (HPLC/UV) analytical method used for determining the combined residues of hexythiazox and its metabolites in dates is adequate for data collection purposes. Adequate method validation data were submitted. This method is based on Method AMR-985-87, which has been deemed acceptable as a tolerance enforcement method in conjunction with a petition for use on apples. The method has been validated for use on various crop commodities, and has been forwarded to the Food and Drug Administration (FDA) for inclusion in Pesticide Analytical Method Volume II (PAM II). This earlier method is considered sufficient to enforce the proposed permanent tolerances for residues in or on dates.

There are no Mexican, Canadian or Codex maximum residue limits (MRLs) established for hexythiazox in or on dates.

An adequate number of residue field trials reflecting the proposed use directions were submitted to EPA to demonstrate that the tolerance for date, dried fruits at 1.0 ppm will not be exceeded when hexythiazox products labeled for this use are used as directed.

As dates are a perennial crop, confined and field rotational crop studies are not required to support the subject petitions.

Therefore, the tolerance is established for combined residues of hexythiazox, trans-5-(4-chlorophenyl)- N -cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the 4-chlorophenyl-4-methyl-2-oxo-3-thiazolidine moiety, in or on date, dried fruit at 1.0 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0036 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 May 5, 2003.

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

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

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

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2002-0036, to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

• Industry (NAICS 111), Crop production.

• Industry (NAICS 112), Animal production.

• Industry (NAICS 311), Food manufacturing.

• Industry (NAICS 32532), Pesticide manufacturing.

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0075. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml__00/Title__40/40cfr180_(_00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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

In the Federal Register of January 9, 2003 (68 FR 1182) (FRL-7287-7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 2E6512) by Makhteshim-Agan of North America Inc., 551 Fifth Ave., Suite 1100 New York, NY 10176. That notice included a summary of the petition prepared by Makhteshim-Agan of North America Inc., the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.191 be amended by establishing a tolerance for residues of the fungicide folpet, (N-(trichloromethylthio)phthalimide), in or on hop at 120 parts per million (ppm).

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of folpet on hop, dried cones at 100 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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

The pygmy rabbit ( Brachylagus idahoensis ) is a member of the family Leporidae, which includes hares and rabbits. The species has been placed in a number of genera since it was first classified in 1891 as Lepus idahoensis (Washington Department of Fish and Wildlife (WDFW) 1995a). In 1904, it was reclassified and placed in the genus Brachylagus. In 1930, it was again reclassified and placed in the genus Sylvilagus. More recent examination of dentition (Hibbard 1963) and analysis of blood proteins (Johnson 1968) suggest that the pygmy rabbit differs significantly from species within either the Lepus or Sylvilagus genera. The pygmy rabbit is now generally considered to be within the monotypic genus Brachylagus, and classified as B. idahoensis (Green and Flinders 1980a; WDFW 1995a). There are no recognized subspecies of the pygmy rabbit (Dalquest 1948; Green and Flinders 1980a).

The pygmy rabbit is the smallest Leporid in North America, with mean adult weights from 375 to about 500 grams (0.83 to 1.1 pounds), and lengths from 23.5 to 29.5 centimeters (cm) (9.3 to 11.6 inches (in)) (Orr 1940; Janson 1946; Wilde 1978; Gahr 1993; WDFW 1995a; T. Katzner, Arizona State University, pers. comm. 2002). Females tend to be slightly larger than males. Pygmy rabbits undergo an annual molt. During summer, their overall color is slate-gray tipped with brown. Their legs, chest, and nape (back of neck) are tawny cinnamon-brown, their bellies are whitish, and the entire edges of their ears are pale buff. Their ears are short (3.5 to 5.2 cm (1.4 to 2.0 in)), rounded, and thickly furred outside. Their tails are small (1.5 to 2.4 cm (0.6 to 0.9 in)), uniform in color, and nearly unnoticeable in the wild (Orr 1940; Janson 1946; WDFW 1995a). The pygmy rabbit is distinguishable from other Leporids by its small size, short ears, gray color, small hind legs, and lack of white on the tail.

Pygmy rabbits are typically found in areas of tall, dense sagebrush ( Artemisia spp.) cover, and are highly dependent on sagebrush to provide both food and shelter throughout the year (Orr 1940; Green and Flinders 1980a; WDFW 1995a). The winter diet of pygmy rabbits is comprised of up to 99 percent sagebrush (Wilde 1978), which is unique among Leporids (White et al. 1982). During spring and summer in Utah, their diet consists of roughly 51 percent sagebrush, 39 percent grasses (particularly native bunch-grasses, such as Agropyron spp. and Poa spp.), and 10 percent forbs (an herb other than grass) (Green and Flinders 1980b). There is evidence that pygmy rabbits preferentially select native grasses as forage during this period in comparison to other available foods. In addition, total grass cover relative to forbs and shrubs may be reduced within the immediate areas occupied by pygmy rabbits as a result of its use as a food source during spring and summer (Green and Flinders 1980b). The specific diets of pygmy rabbit populations likely change depending on the region occupied (T. Katzner, pers. comm. 2002).

The pygmy rabbit is believed to be one of only two Leporids in North America that digs its own burrows (Nelson 1909; Green and Flinders 1980a; WDFW 1995a), the other being the volcano rabbit ( Romerolagus diazi ) found in central Mexico (Durrell and Mallinson 1970). Pygmy rabbit burrows are typically found in relatively deep, loose soils of wind-borne or water-borne ( e.g. , alluvial fan) origin. Pygmy rabbits occasionally make use of burrows abandoned by other species, such as the yellow-bellied marmot ( Marmota flaviventris ) or badger ( Taxidea taxus ) (Wilde 1978; Green and Flinders 1980a; WDFW 1995a) and, as a result, may occur in areas of shallower or more compact soils that support sufficient shrub cover (Bradfield 1974). During winter, pygmy rabbits make extensive use of snow burrows, possibly to access sagebrush forage (Bradfield 1974), as travel corridors among their underground burrows, and/or as thermal cover (Katzner and Parker 1997).

Pygmy rabbits, especially juveniles, likely use their burrows as protection from predators and inclement weather (Bailey 1936; Bradfield 1974). The burrows frequently have multiple entrances, some of which are concealed at the base of larger sagebrush plants (WDFW 1995a). Burrows are relatively simple and shallow, often no more than 2 meters (m) (6.6 feet (ft)) in length and usually less than 1 m (3.3 ft) deep with no distinct chambers (Bradfield 1974; Green and Flinders 1980a; Gahr 1993). Burrows are typically dug into gentle slopes or mound/inter-mound areas of more level or dissected topography (Wilde 1978; U.S. Department of Agriculture (USDA)1991; Gahr 1993). In general, the number of active burrows in an area increases over the summer as the number of juveniles increases. However, the number of active burrows may not be directly related to the number of individuals in a given area because some individual pygmy rabbits appear to maintain multiple burrows, while some individual burrows are used by multiple individuals (Gahr 1993; WDFW 1995a).

Pygmy rabbits begin breeding their second year and, in Washington, breeding occurs from February through July (WDFW 1995a). In some parts of the species' range, females may have up to three litters per year and average six young per litter (Green 1978; Wilde 1978). Breeding appears to be highly synchronous in a given area and juveniles are often identifiable to cohorts (Wilde 1978). No evidence of nests, nesting material, or lactating females with young has been found in burrows (Bradfield 1974; Gahr 1993; WDFW 1995a). Individual juveniles have been found under clumps of sagebrush, although it is not known precisely where the young are born in the wild or if they may be routinely hidden at the bases of scattered shrubs or within burrows (Wilde 1978).

Current information on captive pygmy rabbits indicates that females may excavate specialized “natal” burrows for their litters in the vicinity of their regular burrows (P. Swenson, Oregon Zoo, pers. comm. 2001; L. Shipley, Washington State University (WSU), pers. comm. 2001). Apparently, females begin to dig and supply nesting material ( e.g. , grass clippings) to these burrows several days prior to giving birth, and may give birth and nurse their young at the ground surface in a small depression near the burrow's entrance. After nursing, the young return to the burrow and the female re-fills the burrow entrance with loose soil and otherwise disguises the immediate area to avoid detection. Other “dead-end” burrows that females construct nearby are apparently associated with the natal burrows and may be important for providing proper aeration. Females may also alter their defecation and latrine habits while pregnant and nursing (P. Swenson, pers. comm. 2001). Further work with captive and wild pygmy rabbits should shed additional light on the details of their reproductive strategy.

Pygmy rabbits may be active at any time of the day or night and appear to be most active during mid-morning (Bradfield 1974; Green and Flinders 1980a; Gahr 1993). Pygmy rabbits maintain a low stance, have a deliberate gait, and are relatively slow and vulnerable in more open areas. They can evade predators by maneuvering through the dense shrub cover of their preferred habitats, often along established trails, or by escaping into their burrows (Bailey 1936; Severaid 1950; Bradfield 1974).

Pygmy rabbits tend to have relatively small home ranges during winter, remaining within roughly 30 m (98 ft) of their burrows (Orr 1940; Janson 1946; Gahr 1993; Katzner and Parker 1997), although some snow burrows may extend outward up to 100 m (328 ft) (Bradfield 1974). They have larger home ranges during spring and summer (Orr 1940; Janson 1946; Gahr 1993; Katzner and Parker 1997). During the breeding season in Washington, females tend to make relatively short movements within a small core area and have home ranges covering roughly 2.7 hectares (ha) (6.7 acres (ac)); males tend to make longer movements, traveling among a number of females, resulting in home ranges covering roughly 20.2 ha (49.9 ac) (Gahr 1993). These home range estimates in Washington are considerably larger than for pygmy rabbit populations in other areas of their historic range (WDFW 1995a; Katzner and Parker 1997). Pygmy rabbits may travel up to 1.2 kilometers (km) (0.75 miles (mi)) from their burrows (Gahr 1993), and there are a few records of apparently dispersing individuals moving up to 3.5 km (2.17 mi) (Green and Flinders 1979; Katzner and Parker 1998).

The annual mortality rate of adult pygmy rabbits may be as high as 88 percent, and over 50 percent of juveniles can apparently die within roughly 5 weeks of their emergence (Wilde 1978; WDFW 1995a). However, the mortality rates of adult and juvenile pygmy rabbits can vary considerably between years, and even between juvenile cohorts within years (Wilde 1978). Predation was shown to be the main cause of pygmy rabbit mortality in Idaho (Green 1979). Potential predators include badgers, long-tailed weasels ( Mustela frenata ), coyotes ( Canis latrans ), bobcats ( Felis rufus ), great horned owls ( Bubo virginianus ), long-eared owls ( Asio otus ), ferruginous hawks ( Buteo regalis ), northern harriers ( Circus cyaneus ), and common raven ( Corvus corax ) (Janson 1946; Gashwiler et al. 1960; Green 1978; Wilde 1978; WDFW 1995a; D. Hays, WDFW, pers. comm. 2002; M. Hallet, WDFW, pers. comm. 2002).

Population cycles are not known in pygmy rabbits, although local, relatively rapid population declines have been noted in several States (Bradfield 1974; Weiss and Verts 1984; WDFW 1995a). After initial declines, pygmy rabbit populations may not have the same capacity for rapid increases in numbers as other Leporids due to their close association with specific components of sagebrush ecosystems, and the relatively limited availability of their preferred habitats (Wilde 1978; Green and Flinders 1980b; WDFW 1995a).

The historic distribution of the pygmy rabbit included much of the semi-arid, shrub steppe region of the Great Basin and adjacent intermountain zones of the conterminous western United States (Green and Flinders 1980a), and included portions of Montana, Idaho, Wyoming, Utah, Nevada, California, Oregon, and Washington (Figure 1).

Currently, pygmy rabbits are not distributed continuously across their range, nor were they in the past. Rather, they are found in areas within their broader distribution where sagebrush cover is sufficiently tall and dense, and soils are sufficiently deep and loose to allow burrowing (Bailey 1936; Green and Flinders 1980a; Weiss and Verts 1984; WDFW 1995a). The local distribution of these habitat patches, and thus pygmy rabbits, likely shifts across the landscape in response to various sources of disturbance ( e.g. , fire, flooding, grazing, crop production) combined with long- and short-term weather patterns. In the past, more dense vegetation along permanent and intermittent stream channels, alluvial fans, and sagebrush plains probably provided travel corridors and dispersal habitat for pygmy rabbits between appropriate use areas (Green and Flinders 1980a; Weiss and Verts 1984; WDFW 1995a). Since European settlement of the western United States, more dense vegetation associated with some human activities ( e.g. , fence rows, roadway shoulders, crop margins, abandoned fields) may have also acted as avenues of dispersal between local populations of pygmy rabbits (Green and Flinders 1980a; Pritchett et al. 1987).

There is very little information currently available regarding the prehistoric distribution of the pygmy rabbit throughout the majority of its range. However, the pygmy rabbit has been present within the Columbia Basin, a geographic area that extends from northern Oregon through eastern Washington (Quigley et al. 1997), for over 100,000 years (Lyman 1991). This population segment, which we refer to as the Columbia Basin pygmy rabbit, is believed to have been disjunct from the remainder of the species' range since at least the early Holocene (10,000 to 7,000 years before present (BP)), as suggested by the fossil record (Grayson 1987; Lyman 1991). This separation is in contrast to the relatively short-term, local patterns of isolation, extirpation, and recolonization that likely occur throughout pygmy rabbit range (see above). The Columbia Basin pygmy rabbit probably had a broader distribution during the mid-Holocene (roughly 7,000 to 3,000 years BP) (Lyman 1991). Gradual climate change affecting the distribution and composition of sagebrush communities is thought to have resulted in a reduction of the Columbia Basin pygmy rabbit's range during the late Holocene (3,000 years BP to present) (Grayson 1987; Lyman 1991).

Columbia Basin pygmy rabbits have been considered rare with local areas of occurrence within the Columbia Basin for many years (Dalquest 1948), although there is little comprehensive information available regarding their historic distribution and abundance within this region (WDFW 1995a). Museum specimens and reliable sight records indicate that Columbia Basin pygmy rabbits probably occurred in portions of at least five Washington counties during the first half of the 1900s, including Douglas, Grant, Lincoln, Adams, and Benton (Figure 2).

Once thought to be extirpated, Columbia Basin pygmy rabbits were again located in Washington in 1979. Intensive surveys in 1987 and 1988 discovered five small subpopulations in southern Douglas County; three occurred on State lands and two on private lands (WDFW 1995a). With the exception of a single site record from Benton County in 1979, Columbia Basin pygmy rabbits have been found only in southern Douglas and northern Grant counties since 1956 (WDFW 2000a). The Washington Wildlife Commission designated the pygmy rabbit as a State threatened species in 1990, and reclassified it as endangered in 1993 (WDFW 1995a).

The number of Columbia Basin pygmy rabbit subpopulations and active burrows in Washington has declined over the past decade (WDFW 2001a). Four of the five subpopulations located in 1987 and 1988 were very small, with fewer than 100 active burrows (WDFW 1995a); the largest subpopulation (at the State-owned Sagebrush Flat site in Douglas County) contained roughly 588 active burrows in 1993, when it was estimated to support fewer than 150 rabbits (Gahr 1993). While an additional subpopulation was discovered on private land in northern Grant County in 1997, three of the small subpopulations originally located were extirpated during the 1990s, leaving just three known subpopulations in 1999 (WDFW 2001a).

One of the three remaining sites experienced a catastrophic fire in 1999 and declined to three active burrows, while the newly discovered site in Grant County declined for unknown reasons to two active burrows following the winter of 1999-2000 (WDFW 2001a). These two subpopulations are now thought to be extirpated (WDFW 2001b). In addition, during the winter of 1997-1998, the number of active Columbia Basin pygmy rabbit burrows at the Sagebrush Flat site declined by approximately 50 percent, and has continued to decline each year since (WDFW 2001a). The entire, wild Columbia Basin pygmy rabbit population is now considered to consist of fewer than 30 individuals from just one known subpopulation at the Sagebrush Flat site in Douglas County (D. Hays, pers. comm. 2002).

Although habitat loss and fragmentation have likely played a primary role in the long-term decline of the Columbia Basin pygmy rabbit, it is unlikely that these factors have directly influenced the post-1995 declines at the Sagebrush Flat site and the extirpations of some of the smaller populations (WDFW 2001a). Once populations decline below a certain threshold, they are at risk of extirpation from a number of influences including chance environmental events ( e.g. , extreme weather), catastrophic habitat or resource failure ( e.g. , due to fire or insect infestations), predation, disease, demographic limitations, and loss of genetic heterogeneity. The Columbia Basin pygmy rabbit in the wild is currently at such risk and, without intervention, is likely to become extirpated in the near future (WDFW 2001a).

We added the pygmy rabbit to our candidate species list on November 21, 1991, as a category 2 species (56 FR 58804). A category 2 species was one for which we possessed information indicating that a proposal to list it as threatened or endangered under the Act was possibly appropriate, but for which sufficient data on biological vulnerability and threats were not available to support a proposed rule. In a February 28, 1996, notice, we discontinued the designation of category 2 species as candidates for listing under the Act (61 FR 7596). The Columbia Basin pygmy rabbit was not included as a candidate for listing in this notice.

In FY 2001, the Service was nearly faced with a situation where it could not comply with all its court orders. Early in calendar year 2001, it became apparent that the cost of compliance with existing court orders exceeded our FY 2001 listing funding. After more than 6 months of negotiating, the Service was able to reach an agreement with several plaintiffs that allowed us to postpone a few actions previously scheduled for work in FY 2001. This agreement allowed us to reallocate funding to complete court-ordered work as well as some listing actions. On August 28, 2001, we reached an agreement with the Center for Biological Diversity, Southern Appalachian Biodiversity Project, and the California Native Plant Society to complete work on a number of species proposed for listing. Under this agreement, we were required to issue several final listing decisions, propose a number of other species for listing, and review three species for emergency listing, including the Columbia Basin DPS of the pygmy rabbit (Center for Biological Diversity, et al. v. Norton, Civ. No. 01-2063 (JR) (D.D.C.), entered by the court on October 2, 2001).

On November 30, 2001, we published an emergency rule to list the Columbia Basin pygmy rabbit as endangered (66 FR 59734). We found that emergency listing action was justified because immediate and significant risks to the well-being of this DPS existed due to its recent decreases in population size and distribution over the past several years. Our November 30, 2001, emergency rule provided Federal protection to the Columbia Basin pygmy rabbit pursuant to the Act for a period of 240 days. Concurrently with the emergency rule, we also published a proposed rule to list this DPS as endangered under our normal listing procedures (66 FR 59769). On February 7, 2002, we published a notice in the Federal Register extending the comment period for the proposed rule through February 28, 2002 (67 FR 5780). The comment period was reopened to accommodate requests by State resource agencies and private interests for additional time to provide input. On February 12, 2002, we held a public meeting in East Wenatchee, Washington, to discuss the proposed rule with any interested parties. On July 17, 2002, we published a notice in the Federal Register extending the comment period for the proposed rule through August 1, 2002 (67 FR 46951).

In accordance with section 10(a)(1)(A) of the Act, on December 18, 2001, we issued a recovery permit to the WDFW (TE050644) for their ongoing management actions to protect and conserve the Columbia Basin pygmy rabbit (see Current Management Actions, below). We issued revisions to this permit on January 10, 2002, and March 18, 2002. We also published notices in the Federal Register on December 19, 2001, and March 20 and April 3, 2002, describing the emergency circumstances, announcing receipt of permit applications, and issuing public notice exemptions concerning this permit and its revisions (66 FR 65508, 67 FR 15825, 67 FR 13004).

The WDFW has undertaken a variety of conservation actions for the Columbia Basin pygmy rabbit since 1979 (WDFW 1995a, 2001a). These actions have included population surveys, habitat inventories, land acquisitions, habitat restoration, land management agreements, initiation of studies on the effects of livestock grazing, and predator control. These efforts have been funded by a variety of sources. As funding sources and staffing levels allow, WDFW efforts to conserve the Columbia Basin pygmy rabbit in the wild will continue (D. Hays, pers. comm. 2002).

During the fall of 2000, the WDFW, in cooperation with the Oregon Zoo, initiated a study of husbandry techniques for pygmy rabbits (WDFW 2001a). This study used five pygmy rabbits captured in Idaho and was undertaken to improve the information base for proposed captive propagation and release efforts for the Columbia Basin pygmy rabbit. Due to the continuing decline of pygmy rabbit subpopulations and active burrows in Washington, the WDFW, in cooperation with WSU, expedited their captive propagation efforts for the Columbia Basin pygmy rabbit during the spring of 2001 (WDFW 2001b; D. Hays, pers. comm. 2001).

The main goal of this effort is to capture up to 20 individuals to establish a captive breeding stock. The actual number and type (gender, age, family unit) of pygmy rabbits to be taken from the wild is based partly on information from the ongoing husbandry study of Idaho pygmy rabbits, partly on estimates of what is needed to allow for appropriate manipulation of family lineages to better manage this population's unique genetic profile, and partly on the availability of animals for capture. Any Columbia Basin pygmy rabbits that are not considered essential to the captive propagation effort will be left in the wild, and ongoing management to protect the wild portion of this population will continue.

Since the spring of 2001, 16 Columbia Basin pygmy rabbits (nine females, seven males) have been captured as an initial source for captive breeding efforts (D. Hays, pers. comm. 2002). In addition, shortly after being captured, one female gave birth to a litter of five offspring (two females, three males) that was conceived in the wild (D. Hays, pers. comm. 2001; L. Shipley, pers. comm. 2001). Of the adult rabbits, two males and one female captured from the wild subsequently died (WDFW 2001c). Full necropsies were conducted on these three specimens, with the following results: One male, which died shortly after being captured, may have had reduced body condition while in the wild; the other male died from unknown causes; and the female died due to complications caused by a fall from a sagebrush plant placed in her cage. Several procedures, developed in coordination with results from the ongoing husbandry study, have been implemented to reduce the risk of capture-related mortality of pygmy rabbits. In addition, in order to reduce the risk of catastrophic loss of a single captive population, a number of Columbia Basin pygmy rabbits have been placed at the Oregon Zoo facility. Appropriate measures have been taken to ensure that the Columbia Basin pygmy rabbits remain completely segregated from the pygmy rabbits captured in Idaho that are being used for the husbandry study.

The remaining 18 captive Columbia Basin pygmy rabbits appear to have adjusted well to the two rearing facilities (WDFW 2001c). As opportunities arise, the intent is to capture additional Columbia Basin pygmy rabbits that will complement the genetic profiles and potential breeding scenarios of those already in captivity (D. Hays, pers. comm. 2002; K. Warheit, WDFW, pers. comm. 2002).

The WDFW's captive propagation program affords an opportunity to protect and maintain the Columbia Basin pygmy rabbit until conditions can be made more favorable for its survival in the wild. Ultimately, the goal of the captive propagation effort is to release captive-bred Columbia Basin pygmy rabbits back into suitable habitats within their historic range where viable subpopulations can become re-established and self-sustained in the wild (WDFW 2001b; D. Hays, pers. comm. 2001). The number and size of the wild subpopulations necessary for recovery pursuant to the Act have not yet been determined. Columbia Basin pygmy rabbits within captive rearing facilities will not be counted towards recovery of the species. The timing and objectives for the release phase of the program will be further developed as the captive propagation effort becomes established. The WDFW will remain the lead agency for these efforts, and has developed a Science Advisory Group to provide recommendations and technical oversight for the conservation program. The group is currently comprised of State and Federal agency personnel, public zoo, and university experts, representatives from non-governmental organizations, and private individuals with interests in the conservation of the Columbia Basin pygmy rabbit.

The Nature Conservancy (TNC), a non-governmental natural resource advocacy organization, has acquired, or obtained easements on, portions of the remaining shrub steppe habitat in southern Douglas and northern Grant counties, including the acquisition of approximately 6,900 ha (17,000 ac) adjacent to the WDFW's Sagebrush Flat site. As appropriate, TNC lands in central Washington will be managed to support the conservation efforts undertaken for the Columbia Basin pygmy rabbit (C. Warner, TNC, pers. comm. 2001).

Portions of the remaining shrub steppe habitat in southern Douglas and northern Grant counties are under the jurisdiction of the U.S. Bureau of Land Management (BLM) and State resource agencies. Conservation measures for the Columbia Basin pygmy rabbit are considered in the management of these agency lands (D. Hays, pers. comm. 2001; N. Hedges, BLM, pers. comm. 2001). Many of the existing and future land acquisitions and management actions of the TNC, BLM, and State agencies in this area are targeted at sites recently occupied by the Columbia Basin pygmy rabbit and at providing connectivity of appropriate habitats between these sites.

Large areas of privately owned lands in Douglas County are currently withdrawn from crop production and planted to native and non-native cover under the Federal Conservation Reserve Program (CRP), established in 1985 (USDA 1998). These lands, some of which have been set aside since the late 1980s, provide grass and shrub cover that may improve the habitat conditions of areas potentially occupied or used as dispersal corridors by the Columbia Basin pygmy rabbit. New and re-signed program contracts completed in 1998 increased the acreage of CRP lands in Douglas County. However, contracts extend for just 10 years, and new standards for CRP lands were implemented that required replanting of significant acreage under existing contracts (USDA 1998; M. Schroeder, WDFW, pers. comm. 2001). Presently, it is unclear what effects the CRP lands and current changes to the program may have on the Columbia Basin pygmy rabbit.

Currently, we are assisting private landowners and their conservation districts with development of a county-wide habitat conservation plan (HCP) for agricultural lands in Douglas County, Washington. When completed, the Foster Creek HCP will likely include measures to protect the Columbia Basin pygmy rabbit and may complement other, ongoing conservation efforts in Douglas County.

Pursuant to the Act (16 U.S.C. 1531 et seq. ), we must consider for listing any species, subspecies, or, for vertebrates, any distinct population segment (DPS) of these taxa if there is sufficient information to indicate that such action may be warranted. To implement the measures prescribed by the Act and Congressional direction, the Service and the National Marine Fisheries Service (NMFS) developed a joint policy in 1996 that addresses the recognition of DPS for potential listing actions (61 FR 4722). The policy allows for more refined application of the Act that better reflects the biological needs of the taxon being considered, and avoids the inclusion of entities that do not require its protective measures.

Two elements are used to assess whether a population segment under consideration for listing pursuant to the Act constitutes a DPS. The two elements are: (1) The population segment's discreteness from the remainder of the taxon; and (2) the population segment's significance to the taxon to which it belongs. A systematic application of these elements is appropriate, with discreteness criteria applied first, followed by significance analysis. If we determine that a population segment being considered for listing represents a DPS, then the status of the population and level of threats to the population segment is evaluated based on the five listing factors established by the Act to determine if listing the DPS as either threatened or endangered is warranted.

Discreteness may be demonstrated by either, or both, of the following: (1) Physical, physiological, ecological, behavioral, morphological, or genetic discontinuity between population segments; or (2) international governmental boundaries between which differences in regulatory mechanisms exist that are significant with regard to conservation of the taxon. The pygmy rabbit does not occur outside of the lower 48 conterminous United States, so the international boundary criterion does not apply.

The Columbia Basin pygmy rabbit has been physically discrete from the remainder of the taxon for several millennia ( see Distribution and Status, above). In addition, there is current evidence that the Columbia Basin pygmy rabbit is genetically and ecologically discrete from the remainder of the taxon ( see Significance, below). Based on this information, we find that the Columbia Basin pygmy rabbit population segment is discrete from the remainder of the taxon pursuant to the Act. Physiological, behavioral, or morphological differences between the Columbia Basin pygmy rabbit and populations throughout the remainder of the species' range are not known at this time.

The types of information that may demonstrate the significance of a discrete population segment to the remainder of its taxon include, but are not limited to: (1) Persistence of the population segment in an ecological setting unusual or unique for the taxon; (2) evidence that loss of the population segment would result in a significant gap in the range of the taxon; (3) evidence that the discrete population segment represents the only surviving natural occurrence of the taxon that may be more abundant elsewhere as an introduced population outside its historic range; and (4) evidence that the population segment differs markedly from other population segments in its genetic characteristics. The following significance factors have bearing on the Columbia Basin pygmy rabbit.

Markedly different genetic characteristics. Several studies have been initiated to investigate the pygmy rabbit's genetic profile (WDFW 2000c; WDFW 2001a, c; Cegelski and Waits, undated). To date, the genetic analyses include current ( ca 1990s to present) samples from Washington, Idaho, and Montana; and museum specimens ( ca 1910s to 1980s) from Washington, Idaho, Montana, and Oregon, with a median date of 1949 among these States (WDFW 2001c). Analyses have included both mitochondrial DNA (from current samples only) and nuclear DNA markers (WDFW 2001c; K. Warheit, pers. comm. 2001, 2002).

Results from recent genetic analyses indicate that the Columbia Basin pygmy rabbit is markedly different from other pygmy rabbit population segments (WDFW 2001c; K. Warheit, pers. comm. 2001, 2002). These differences are consistent in both mitochondrial DNA and nuclear DNA indices, and between current (Washington versus Idaho and Montana) and museum (Washington versus Idaho, Montana, Oregon) samples. The genetic results suggest that the Columbia Basin pygmy rabbit diverged ( i.e., was genetically isolated) from the remainder of the taxon at least 10,000 to 25,000 years BP, and possibly as long as 40,000 to 115,000 years BP (WDFW 2001c; K. Warheit, pers. comm. 2001, 2002). The genetic differences that have so far been identified between the Columbia Basin pygmy rabbit and other pygmy rabbit populations are similar in nature to subspecific differences recognized in other mammal species. However, potential taxonomic reorganization of the pygmy rabbit species will require additional study (WDFW 2001c).

In addition to the genetic differences that likely result from long-term isolation described above, the Columbia Basin pygmy rabbit also exhibits significantly less genetic diversity compared to other pygmy rabbit populations. Furthermore, the level of genetic diversity in this population segment has declined significantly and at an accelerated rate since the mid-1900s (Washington current versus Washington museum specimens). These results suggest a recent and rapid decline in the effective population size ( i.e., the number of individuals contributing to reproduction) of the Columbia Basin pygmy rabbit, and that this population segment may be experiencing a degree of inbreeding depression (WDFW 2001c).

Two conclusions may be drawn from the recent results of the genetic research on the pygmy rabbit—(1) the unique genetic characteristics of the Columbia Basin pygmy rabbit represent an important component in the evolutionary legacy of the species and, therefore, a genetic resource worthy of conservation; and (2) efforts should be undertaken to address the low level of genetic diversity within this population segment (K. Warheit, pers. comm. 2001, 2002).

Persistence in an unusual or unique ecological setting. With regard to the historic distribution of the pygmy rabbit, several studies have defined and mapped landscape-level ecosystem components of Washington and Oregon and, to varying degrees, address the management of natural resources within these regional ecosystems (Daubenmire 1988; Franklin and Dyrness 1988; Keane et al. 1996; Quigley et al. 1997; Wisdom et al. 1998). Although there are considerable differences between the studies, the ecosystem mapping units that were developed as a result of these studies are relatively consistent. These ecosystem mapping units are important for determining if the Columbia Basin pygmy rabbit may occupy an unusual or unique ecological setting. In addition, it is important for delineating the boundaries of any potential DPS in the region, as required by our DPS policy. Currently, there is insufficient information available to address the other shrub steppe ecosystems comprising historic pygmy rabbit range outside of Washington and Oregon.

During the early 1900s, the pygmy rabbit populations in Washington and Oregon (Figure 2) occurred in five ecosystems identified by the above studies. For the purposes of this DPS analysis, we refer to these ecosystems as the Columbia Basin, High Lava Plains, Northern Great Basin, Owyhee Uplands, and Modoc Plateau (after Quigley et al. 1997). The Columbia Basin occurs in Washington and northern Oregon; the other four ecosystems occur in central and southern Oregon (Figure 3).

These ecosystems are interspersed to varying degrees with forested habitats of the Southern and Eastern Cascades ecosystems to the west, Okanogan Highlands to the north, Bitterroot and Blue Mountains to the east, and steppe (grassland) habitats of the Palouse Prairie to the east.

The historic range of the Columbia Basin pygmy rabbit occurred entirely within the Columbia Basin of central Washington, and this population segment has been the only representation of the taxon within this ecosystem for thousands of years. During the early 1900s, the population segment of pygmy rabbits in central and southern Oregon was apparently locally dispersed across the High Lava Plains, Northern Great Basin, Owyhee Uplands, and Modoc Plateau (Figures 2 and 3). The distribution of the pygmy rabbit in Oregon has likely declined during the last century (Weiss and Verts 1984; WDFW 2000b) and, currently, primarily encompasses areas within the Northern Great Basin ecosystem.

A number of significant differences are found between the Columbia Basin ecosystem and the balance of pygmy rabbit range in central and southern Oregon. In general, the Columbia Basin is lower in elevation, contains soils of varying origin, and has been influenced by different geological processes. These structural differences, combined with regional climatic conditions, significantly influence the broad plant associations found within each ecosystem (Daubenmire 1988; Franklin and Dyrness 1988). Historically, transitional steppe habitats were much more prevalent in the Columbia Basin than in the ecosystems of central and southern Oregon. In contrast, juniper ( Juniperus spp) woodlands and salt-desert shrub habitats were much more common in central and southern Oregon. Finally, there are significant differences in the type and distribution of sagebrush taxa among the ecosystems (Table 1).

There are a number of broad habitat associations in common between the Columbia Basin and the ecosystems of central and southern Oregon (Daubenmire 1988; Franklin and Dyrness 1988). However, even within these common habitat associations, notable differences exist. In general, the composition of forb species differs considerably between the Columbia Basin and the ecosystems in central and southern Oregon ( cf Daubenmire 1988; Franklin and Dyrness 1988). Even when the same forb species may be present, the two regions typically support different subspecies or varieties of these taxa (Hitchcock and Cronquist 1973).

Currently, it is unclear if the Columbia Basin pygmy rabbit is different in several respects ( i.e. , physiologically, behaviorally, or morphologically) from other pygmy rabbit populations throughout the remainder of the species' historic range. However, based on the above ecological information, and the pygmy rabbit's close association with sagebrush ecosystems, we conclude that the Columbia Basin represents a unique ecological setting for the taxon due to its different geologic, climatic, edaphic (soil), and plant community components. In addition, the Columbia Basin ecosystem holds different management implications for the Columbia Basin pygmy rabbit compared to the ecosystems of southern Oregon and the population segment of pygmy rabbits occupying that region ( see above), and likely also compared to the other sagebrush ecosystems and population segments found throughout the remainder of the species' range ( see Background, above, and Summary of Factors Affecting the DPS, below).

Significant gap in the range of the taxon. The Columbia Basin pygmy rabbit represents an isolated portion of the northern-most extent of the historic distribution of the taxon (Figure 1). Paleontological records indicate that the prehistoric distribution of this population segment ( ca 150 to 10,000 + years BP) may have encompassed roughly 23 percent of the Columbia Basin (after Lyman 1991). As recently as the early 1900s, this population segment was distributed across approximately 10 percent of the Columbia Basin ecosystem ( cf Figures 2 and 3). Currently, the Columbia Basin pygmy rabbit occurs in less than 1 percent of its overall historic distribution, and a small fraction of its potential prehistoric distribution.

A number of studies address the characteristics of peripheral and/or isolated populations and their influences on, and importance to, the remainder of the taxon. These studies indicate that peripheral and isolated populations may experience increased directional selection due to marginal or varied habitats at range peripheries, exhibit adaptations specific to these differing selective pressures, demonstrate genetic consequences of reduced gene flow dependent on varying levels of isolation, and/or have different responses to anthropogenic influences (Levin 1970; MacArthur 1972; Morain 1984; Lacy 1987; Hengeveld 1990; Saunders et al. 1991; Hoffmann and Blows 1994; Furlow and Armijo-Prewitt 1995; Garcia-Ramos and Kirkpatrick 1997).

The available information regarding the past distribution and isolation of the Columbia Basin pygmy rabbit demonstrates that this population segment is likely experiencing increased directional selection due to marginal and varied habitats at the periphery of the taxon's range. In addition, this population segment is exhibiting genetic consequences of long-term isolation from other population segments and is responding, and will continue to respond, to the different anthropogenic influences in the region.

Based on the above information, we conclude that the loss of the Columbia Basin pygmy rabbit would represent a significant gap in the range of the taxon, due to the loss of a conspicuous peripheral and isolated extension of its current and historic range.

Based on the available information described above, we find that the Columbia Basin pygmy rabbit is discrete from, and significant to, the remainder of the taxon, and thus constitutes a DPS. The discreteness of this population segment is demonstrated by its physical, genetic, and ecological isolation from the remainder of the taxon. The significance of this population segment is demonstrated by: (1) Its genetic characteristics, which differ markedly from other population segments; (2) its long-term persistence in the unique ecological setting of the Columbia Basin; and (3) the significant gap in the current and historic range of the taxon that the loss of this population segment would represent. As required by our DPS policy, we have determined that the bounds of this DPS are conterminous with the historic distribution of the pygmy rabbit within the Columbia Basin ecosystem (Figure 2).

In our November 30, 2001, proposed rule (66 FR 59769) and associated notifications, we requested that all interested parties submit comments, data, or other information that might contribute to development of a final listing decision. The comment period for the proposed rule was originally open from November 30, 2001, through January 29, 2002. During this period, we received a number of requests to extend the comment period and five requests to hold a public hearing to address the proposed rule. On February 7, 2002, we extended the comment period for the proposed rule through February 28, 2002. In addition, after coordinating meeting details with the requesters, on February 12, 2002, we held a public meeting in East Wenatchee, Washington, to present the information we had available on the Columbia Basin pygmy rabbit, to receive input, and to discuss the proposed rule with any interested parties. On July 17, 2002, we extended the comment period for the proposed rule through August 1, 2002.

On November 30, 2001, February 7, 2002, and July 17, 2002, we contacted appropriate Federal, State, tribal, and local resource agencies and governmental offices, scientific organizations, agricultural organizations, outdoor user groups, environmental groups, and other interested parties and requested that they comment on the proposed rule. We established several methods for interested parties to provide comments and other materials, including verbally or in writing at the public meeting, by letter, facsimile, or, during the original and final open comment periods, by electronic mail. Notices of the extended comment period and public meeting announcement were also published in local newspapers on February 7, 2002, including the Wenatchee World, Columbia Basin Herald, and Spokesman Review.

We received a total of 34 letters, facsimiles, comment cards, and electronic mailings from the public with comments and/or questions concerning the proposed rule on the Columbia Basin pygmy rabbit during the three comment periods. We also received 2 letters from the same individual. Of the comments received, 9 were in support of the listing action, 6 were opposed to the listing, and 19 were neutral.

We revised and updated the information contained in this final rule to reflect the additional information we received during the open comment period for the proposed rule. We address substantive comments concerning various aspects of the proposed rule, below. General topics are categorized and comments of a similar nature under each topic are grouped together below, along with our response to each.

Issue 1: We received a number of requests to explain more fully what the potential effects of listing the Columbia Basin pygmy rabbit would be on private lands, or private management actions on public lands, throughout the population's historic distribution.

Our Response: Once a species becomes listed, either through our emergency or normal listing process, section 9 of the Act sets forth a series of general prohibitions that apply to that species. Of primary concern for Columbia Basin pygmy rabbits, the prohibitions make it illegal for any person subject to the jurisdiction of the United States to “take” them. The definition of “take” under the Act includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, collect, or attempt to engage in any such conduct. “Harm” is further defined to include significant habitat modification or degradation that results in death or injury to the listed wildlife by significantly impairing behavioral patterns such as breeding, feeding, or sheltering. “Harass” is further defined to include actions that create the likelihood of injury to listed wildlife by annoying it to such an extent as to significantly disrupt normal behavior patterns which include, but are not limited to, breeding, feeding, or sheltering. Other general prohibitions make it illegal to import or export listed wildlife or its parts or products, transport it in interstate or foreign commerce in the course of commercial activity, or sell it or offer it for sale in interstate or foreign commerce. Section 11 of the Act describes the civil and criminal penalties that may be imposed on any individual or organization that violates these prohibitions.

Section 10 of the Act provides a number of exceptions to the prohibitions against prescribed in section 9. In other words, activities that could result in take of the Columbia Basin pygmy rabbit may be permitted by the Service if certain conditions are met. Under section 10(a)(1)(A), we may permit activities otherwise prohibited by section 9 if they are conducted for scientific purposes or to enhance the propagation or survival of the Columbia Basin pygmy rabbit (recovery permits). Under section 10(a)(1)(B), we may permit activities otherwise prohibited by section 9 if the resulting take is incidental to, and not the purpose of, the otherwise lawful activities (incidental take permits). In order for us to issue an incidental take permit, an applicant must submit an HCP that specifies: (1) The impact that will likely result from such taking; (2) what steps will be taken to minimize and mitigate such impacts, and the funding that will be available to implement such steps; (3) what alternative actions to such taking were considered and the reasons why such alternatives are not used; and (4) other such measures that the Secretary of Interior (Secretary) may require.

With regard to non-Federal property, if pygmy rabbits are not present on the property, the Act's taking prohibition would not apply there. Where non-Federal property is occupied by the Columbia Basin pygmy rabbit, if management activity would not result in take, section 9 would also not apply. Even if non-Federal property is occupied by the pygmy rabbit and management activities are likely to result in take, an incidental take permit may still be available under section 10(a). Service and technical assistance will be available to landowner(s) and/or operator(s) to help them avoid, minimize, or mitigate any adverse impacts to the Columbia Basin pygmy rabbit.

Proposed activities authorized, funded, or carried out by a Federal agency are subject to the consultation requirements Congress prescribed in section 7 of the Act. Circumstances under which a proposed Federal action or Federal nexus may affect the Columbia Basin pygmy rabbit will be handled through consultation with the involved Federal agency and applicant(s), as necessary, on a case-by-case basis, in accordance with section 7 of the Act.

Issue 2: Various commenters expressed concern regarding circumstances where landowners or operators of currently unoccupied habitat are adjacent to occupied sites or areas potentially used for reintroduction efforts, and what the consequences of future occupation of these lands by the Columbia Basin pygmy rabbit may be.

Our Response: Authorization of take of rabbits incidental to otherwise lawful activities may be available through development of HCPs and issuance of incidental take permits in accordance with section 10(a) of the Act. In addition, landowners or operators may enter into Safe Harbor Agreements that provide regulatory assurances to landowners who manage their properties in such a way as to attract Columbia Basin pygmy rabbits. As with currently occupied habitats, we will continue to work cooperatively with, and provide technical assistance to, landowners and operators to help them avoid, minimize, or mitigate any potential future impacts to the Columbia Basin pygmy rabbit.

Issue 3: We received a number of comments concerning critical habitat and how it relates to the emergency, proposed, and final rules for the Columbia Basin pygmy rabbit.

Our Response: Neither our emergency, proposed, nor this final rule designates critical habitat for the Columbia Basin pygmy rabbit. We find that designation of critical habitat for the Columbia Basin pygmy rabbit is not determinable at this time because information sufficient to perform the required analyses of the impacts of the designation is lacking ( see Critical Habitat, below). We will continue to protect the Columbia Basin pygmy rabbit and its habitat through section 7 consultations on Federal actions that may affect this population segment, through the recovery process, through HCPs under section 10, and through enforcement of take prohibitions under section 9 of the Act.

Issue 4: Several comments suggested the need for NEPA analyses, or requested an explanation of why the NEPA process is not necessary, for this final rule.

Our Response: We have determined that environmental assessments (EAs) and environmental impact statements (EISs) developed pursuant to NEPA do not need to be prepared in connection with regulations adopted pursuant to the listing process under section 4(a) of the Act. The Federal Council on Environmental Quality has determined, based on court decisions, that listing actions under the Act are exempt from NEPA review as a matter of law. We published a notice that further describes our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

Issue 5: We received a number of comments and questions concerning how new information about the presence of additional subpopulations of Columbia Basin pygmy rabbits may affect the status of the population, the listing process, or this final rule.

Our Response: If significant new information becomes available regarding additional subpopulations of Columbia Basin pygmy rabbits, the new information could affect the priority of the management actions identified for the captive propagation program and/or the ongoing conservation actions being implemented for the remaining wild portion of the population. The information we currently have available indicates that it is unlikely that a sufficiently large, well distributed “unknown” subpopulation may still occur that would completely remove the need for protection of the species under the Act. No additional information on locations of other subpopulations of Columbia Basin pygmy rabbits was provided during the comment period.

Issue 6: We received a number of comments and questions concerning how we determined the historic range of the pygmy rabbit, what the abundance and status of various pygmy rabbit populations are, how abundance estimates are determined, and the causes behind the recent declines in the Columbia Basin pygmy rabbit.

Our Response: Information concerning the current, historic, and prehistoric distribution of the Columbia Basin pygmy rabbit population primarily comes from scientific literature, including peer-reviewed journal articles, doctoral dissertations, master's theses, and/or State natural resource agency reports and data. These sources are referenced within the body of the rule, as appropriate. As discussed above ( see Distribution and Status), there is very little information currently available regarding the abundance of pygmy rabbits throughout the majority of their current range. Due to the ongoing efforts of the WDFW to monitor and study pygmy rabbits over the last several decades, there is considerably more information available regarding the current abundance and distribution of the Columbia Basin population.

With regard to the past distribution and abundance of the Columbia Basin pygmy rabbit, we assume that this population was more broadly distributed and had a greater abundance of individuals within this region historically. This assumption is based on the available information addressing other pygmy rabbit populations, the population dynamics of other Leporid species, and the general concepts and theory of minimum viable populations. Given this available information, it is unlikely that the Columbia Basin pygmy rabbit would have persisted within this region for thousands of years with such a limited distribution and at such minimum abundance levels. Nevertheless, the available information only indicates the occurrence of several small subpopulations in portions of five counties in central Washington since the early 1900s. As such, the historic distribution and abundance of the Columbia Basin pygmy rabbit that we report in this final rule represent minimum estimates.

Obtaining precise estimates of wildlife abundance levels is often very difficult. This is because: (1) The abundance of many wildlife populations naturally fluctuates between years, and even between seasons within years; (2) individuals are often difficult to observe; (3) individuals often move between observations or there is an unknown amount of mixing of individuals between observed areas; and (4) observation techniques can affect the behavior of the individuals being observed. Because of these limitations, managers often use a “surrogate”, or index, to estimate a probable range of values concerning wildlife abundance levels. With regard to pygmy rabbits, the occurrence of their burrows and estimates of the burrows' ages and/or activity levels ( e.g., active, fresh, old, very old) are typically used to monitor the status of a given population.

We understand that there are limitations in the available information addressing the current and historic distribution and abundance of the Columbia Basin and other pygmy rabbit populations. However, the available information provides several important parameters with regard to our listing determination, including: (1) The distribution of the Columbia Basin pygmy rabbit has declined dramatically from historic levels; (2) five of six known subpopulations remaining in the mid-1990s have been extirpated; and (3) the abundance of active burrows and, by extension, individual pygmy rabbits within the last known occupied site, has declined dramatically over this same recent time period. The estimates of individual Columbia Basin pygmy rabbits known to remain in the wild, as presented in the proposed rule and this final rule, represent maximum estimates and are based on the best professional judgement of recognized experts.

As discussed below ( see Summary of Factors Affecting the DPS), several factors and their interactions are implicated in the historic and recent declines of the Columbia Basin pygmy rabbit, including habitat conversion and fragmentation, wildfire, predation, livestock grazing, and disease. However, addressing the extremely small size and limited distribution of this population is our primary concern for the immediate conservation and protection measures for the Columbia Basin pygmy rabbit. Measures to address the more general and/or long-term threat factors will be identified as our recovery program is further developed ( see Captive Propagation and Recovery, below).

Issue 7: We received a large number of comments concerning our interpretation of the available information with regard to livestock grazing and the potential effects it has on the Columbia Basin pygmy rabbit. Some comments suggested that we were overly critical concerning the negative effects of livestock grazing and did not adequately address its potential benefits to the Columbia Basin pygmy rabbit. In contrast, other comments suggested that we down-played the negative effects of livestock grazing and implied that regulatory restrictions should be placed on grazing activities in all areas currently or potentially used by the Columbia Basin pygmy rabbit.

Our Response: As with the available information addressing distribution and abundance (see above response), we understand that there are limitations in the available information concerning the effects of livestock grazing on the Columbia Basin pygmy rabbit. However, with regard to adverse effects of livestock grazing, the one study available found several important characteristics—(1) Male Columbia Basin pygmy rabbits tend to make longer movements and require larger home ranges during the breeding season in recently grazed areas as opposed to areas that have not been grazed for several decades (Gahr 1993); (2) there tend to be fewer burrows available to, or constructed by, Columbia Basin pygmy rabbits in recently grazed areas (L. Shipley, pers. comm. 2001); (3) Columbia Basin pygmy rabbits occupying recently grazed sites tend to have a greater proportion of their summer through winter diets composed of sagebrush as opposed to grasses and forbs (L. Shipley, pers. comm. 2001); (4) the nutritional quality of the available grasses and shrubs tends to be less from fall through spring in recently grazed areas (L. Shipley, pers. comm. 2002); and (5) livestock can directly damage pygmy rabbit burrow systems through trampling (Rauscher 1997; N. Siegel, WSU, pers. comm. 2001; M. Hallet, pers. comm. 2002).

Other, more general, information also suggests the adverse effects on the Columbia Basin pygmy rabbit associated with livestock management activities. These other potential impacts include sagebrush control efforts, effects on predator distribution and density through the use of artificial watering or supplemental nutrition and feeding sources for livestock, structural damage to dense stands of sagebrush by livestock, removal of current herbaceous growth or residual cover of native grasses and forbs by livestock for forage, and increases in the density or distribution of various invasive weed species.

The available information described above suggests there is a potential for take of the Columbia Basin pygmy rabbit to occur, as defined by the Act, in association with some livestock grazing operations. These potential impacts may be in the form of direct take ( e.g., injury or mortality due to trampling of occupied burrows or sagebrush eradication efforts), or in the form of indirect take ( e.g., harm or harassment due to habitat modification or degradation that significantly impairs normal behavioral patterns associated with the Columbia Basin pygmy rabbit's breeding, feeding, or sheltering activities). Due to the extremely low number and restricted distribution of Columbia Basin pygmy rabbits, additional mortality resulting from livestock grazing practices currently represents a potentially significant threat to their continued existence.

Pygmy rabbits have coexisted with various levels of livestock grazing activities throughout their historic range for many years. Currently, it is unclear if light or moderate levels of livestock grazing may be compatible with, or even beneficial to, long-term conservation efforts for otherwise secure populations of pygmy rabbits. The effects of livestock grazing that have been identified to potentially benefit the Columbia Basin pygmy rabbit include: (1) Increasing the vigor of grass species through mechanical disturbance by livestock; (2) increasing the abundance of sagebrush cover through altered competitive advantage by removal or reduction of associated shrub steppe vegetation; (3) increasing the biological diversity of wildlife and vegetation species; and (4) creating more open habitats that provide improved security through increased visual line-of-sight for pygmy rabbits.

It is our intention, once the captive propagation program becomes better established and appropriate protection measures are in place to ensure the security of the remaining wild portion of the population, to reinitiate or support future studies to address the potential effects of livestock grazing (both positive and negative) on the Columbia Basin and/or other pygmy rabbit populations. These efforts should attempt to include the evaluation of pygmy rabbits in areas subject to various intensities and timing of livestock grazing, areas where livestock grazing has been discontinued for known periods of time, sites that have historically remained free of livestock grazing, and areas of varying soils and initial ecosystem conditions. These evaluations will help fill the current information gaps regarding the effects of livestock grazing on the Columbia Basin pygmy rabbit and provide a basis for analyzing grazing activities under sections 7 and 10(a) of the Act.

The specific conditions under which livestock grazing activities will be addressed in habitats occupied by the Columbia Basin pygmy rabbit will be further defined as our recovery program is developed ( see Captive Propagation and Recovery, below).

Issue 8: We received several comments concerning the effects of current and historic grazing by native herbivores, such as white-tailed deer ( Odocoileus virginianus ), mule deer ( O. hemionus ), elk ( Cervus elaphus ), and American bison ( Bison bison ), on the Columbia Basin pygmy rabbit. In addition, some comments expressed concern regarding why this form of grazing is treated differently than the effects of livestock grazing and what management actions we may undertake to address these grazing effects.

Our Response: The available information suggests that the shrub steppe habitats of the Columbia Basin evolved in the absence of substantial grazing pressure from large native herbivores since the latest period of glaciation, roughly 12,000 years BP (Mack and Thompson 1982; Daubenmire 1988; Lyman and Wolverton 2002). Deer and elk are also primarily browsing, as opposed to grazing, animals. In addition, the ecological effects of grazing by various livestock ( e.g., cattle, horses, sheep) are not typically considered to be comparable to those of native herbivores (Lyman and Wolverton 2002). In relatively large, well distributed pygmy rabbit populations, we would not expect grazing by native herbivores to represent a significant threat to their long-term security.

Historically, central Washington supported extensive livestock grazing operations throughout the shrub steppe habitats potentially used by the Columbia Basin pygmy rabbit (Daubenmire 1988; WDFW 1995a). Excessive livestock grazing pressure can have significant impacts on the shrub steppe ecosystems found throughout the historic range of the Columbia Basin pygmy rabbit (Fleischner 1994), and these impacts may be exacerbated in the Columbia Basin (see above response). Contemporary grazing levels are much reduced from historic levels; however, large livestock operations continue within the shrub steppe habitats of the Columbia Basin to the present. From 1986 to 1993, an average of roughly 280,000 cattle were being supported in the five central Washington counties that historically harbored the Columbia Basin pygmy rabbit (WDFW 1995b).

The available information suggests that the historic and seasonal use patterns and concentrations of native herbivores and their associated grazing effects within the Columbia Basin are considerably different from those of livestock operations. In addition, the available information does not indicate that natural levels of grazing by native herbivores, or their grazing patterns as they may have been altered by contemporary human activities, currently represent a risk to the Columbia Basin pygmy rabbit.

Issue 9: We received a number of questions and comments concerning our interpretation of the available information addressing predation and disease and the potential effects they have on the Columbia Basin pygmy rabbit. In addition, several commenters raised issues and questions concerning our potential future management actions to address these threat factors.

Our Response: Information concerning the potential current and historic impacts from predation and disease on the Columbia Basin and other pygmy rabbit populations primarily comes from scientific literature, including peer-reviewed journal articles, doctoral dissertations, master's theses, and/or State natural resource agency reports and data. In addition, the past and current management efforts that the WDFW has undertaken to address these threat factors are presented in the preamble to the rule. The details of planned future Federal management actions to address these threat factors will be further defined as our recovery program is developed ( see Captive Propagation and Recovery, below).

The available information suggests that in relatively large, well distributed pygmy rabbit populations, predation and disease are not likely to represent a significant threat to their long-term security. However, due to the extremely small size and localized occurrence of the Columbia Basin pygmy rabbit, the available information suggests that human-altered predation and/or disease patterns, and even natural levels of predation and disease, may significantly impair conservation efforts for the remaining wild and captive portions of this population segment.

Issue 10: We received a number of comments regarding the captive propagation program established by the WDFW and our potential management activities to address recovery of the Columbia Basin pygmy rabbit. These comments addressed a wide variety of issues and questions, including the health and breeding success of captive pygmy rabbits, impacts to pygmy rabbit populations associated with research or conservation efforts, other potential differences between the various pygmy rabbit populations ( e.g. , physiological, behavioral, morphological), the survival characteristics of captive bred versus wild individuals, habitat enhancement or restoration standards for mitigation efforts, Federal recovery policy for down-listing or delisting the Columbia Basin pygmy rabbit, and reintroduction protocols and potential release sites for the recovery program.

Our Response: The available information we have regarding the biology and ecology of the Columbia Basin pygmy rabbit, impacts to the populations, and mitigation efforts is referenced within the preamble to this final rule.

The WDFW's captive propagation program affords an opportunity to maintain a sufficient number of Columbia Basin pygmy rabbits in captivity until appropriate recovery measures are developed and implemented to ensure the population's survival in the wild. Ultimately, the goal of the captive propagation effort is to release captive-bred Columbia Basin pygmy rabbits back into suitable habitats within their historic range so that viable subpopulations can become re-established. However, the number and size of the wild subpopulations necessary for recovery pursuant to the Act have not yet been determined.

Listing the Columbia Basin pygmy rabbit as endangered will provide for the development of a recovery plan. Such a plan would bring together Federal, State, and local efforts for the conservation of the species to form a recovery planning team. During the Federal recovery planning process, a team develops a plan to establish a framework for agencies to coordinate recovery efforts and cooperate with each other in conservation efforts. A recovery plan will set recovery objectives and priorities, such as habitat enhancement and/or restoration efforts, reintroduction protocols, and potential release sites, assign responsibilities to achieve those goals and objectives, and estimate costs of various tasks necessary to achieve conservation and survival of this species. A recovery plan will also identify goals and objectives that need to be met in order to downlist or delist the species. The following comments may provide further clarification.

Issue 11: Concern was expressed regarding possible mixing of Columbia Basin pygmy rabbits being held in captivity with those from the Idaho population being used for the husbandry studies.

Our Response: There have been no instances of intermixing between the two source populations of captive pygmy rabbits. The WDFW, WSU, and Oregon Zoo implemented a number of appropriate measures to avoid the possibility of commingling of Columbia Basin and other pygmy rabbits being held in captivity. These, and additional measures, were also made conditions of the December 18, 2001, recovery permit we issued for the captive propagation program ( see Previous Federal Action, above). These measures include maintaining secure and appropriately marked cages, providing discrete holding areas or separation fencing between cages, and developing and adhering to strict transport and handling procedures to minimize any potential for direct contact between the captive pygmy rabbit populations. Furthermore, notification of any instances of commingling of Columbia Basin and other pygmy rabbits will be provided to the Service within 3 working days of the incident, and will include a description of the circumstances under which the commingling occurred and corrective measures to address that and any potential future incidents.

Issue 12: Concerns were expressed regarding the potential impacts to the Columbia Basin pygmy rabbit from various ongoing research and conservation activities, and our potential actions to address these concerns.

Our Response: We recognize that certain research and conservation activities have the potential to directly and indirectly affect the Columbia Basin pygmy rabbit. The available information addressing the circumstances under which these impacts may be occurring, or have the potential to occur in the future, are referenced in the preamble to the rule, as appropriate.

Research and management activities for the Columbia Basin pygmy rabbit will be regulated under the section 10 permitting process. The WDFW has closely coordinated its management activities to conserve the Columbia Basin pygmy rabbit with us. In addition, in cooperation with the WDFW, WSU, and the Oregon Zoo, we have developed a number of appropriate measures to avoid or reduce the risk of take of the Columbia Basin pygmy rabbit. These measures were made conditions of the December 18, 2001, recovery permit and its revisions that we issued for the captive propagation program and ongoing management activities at the Sagebrush Flat site ( see Previous Federal Action, above). We will continue to work cooperatively with interested parties on activities conducted for scientific purposes or to enhance the propagation or survival of the Columbia Basin pygmy rabbit under section 10 of the Act.

Issue 13: Concern was expressed regarding our use and incorporation of information from other pygmy rabbit populations in the background biological discussions and other sections of the emergency and proposed listing rules. In addition, questions were raised regarding whether this information is appropriate or applicable to the Columbia Basin pygmy rabbit.

Our Response: Wildlife investigations often use information concerning closely related populations, subspecies, species, and even genera when making biological inferences about a given population. It is important that any inferences made from these comparisons recognize the potential differences between the populations (or higher taxa), and that any conclusions are limited to what the available information supports. However, understanding the life history of a closely related population (or higher taxa) is often beneficial, and at times even essential, to a more complete understanding of the population of interest. While the Columbia Basin pygmy rabbit is distinct from other pygmy rabbit populations, we recognize that they share many similarities in their life history characteristics. Recognizing these similarities is critical to our understanding of the Columbia Basin population.

Service policy concerning the consideration of a DPS for listing under the Act requires us to evaluate the discreteness and significance of a given population in comparison to the remainder of its taxon. Considering all of the available information on a species helps determine if significant differences may exist between its discrete populations.

Issue 14: Several commenters expressed concern regarding the area affected by the listing, and the potential extent of reintroduction efforts that may be undertaken to address recovery of the Columbia Basin pygmy rabbit.

Our Response: This final rule lists as endangered the pygmy rabbit in the Columbia Basin of central Washington (Figure 2). Appropriate sites within this region that could potentially be used for reintroduction efforts will be identified as our recovery program is further developed. Pygmy rabbit populations in other States throughout the species' historic range are not included in this listing action, nor will any areas outside of the historic range of the Columbia Basin pygmy rabbit population be considered for any recovery actions.

In accordance with our policy published on July 1, 1994 (59 FR 34270), we sought independent expert review by seven specialists during the comment period on the proposal to list the Columbia Basin pygmy rabbit. The purpose of these reviews is to ensure that listing decisions are based on scientifically sound data, assumptions, and analyses. The seven independent reviewers would provide expertise on pygmy rabbit biology, population genetics, Columbia Basin shrub steppe ecology and rangeland management. Six of these reviewers submitted comments on the proposed listing, and one did not respond. Experts that provided comments include: Two pygmy rabbit researchers, one from Arizona State University and one from Idaho State University; a research wildlife biologist from the Biological Resources Division of the U.S. Geological Survey; a population geneticist from the University of Denver; a research biologist from the WDFW; and a senior scientist from NMFS. All of the experts concurred that the proposed listing action was justified and appropriate. We have incorporated their comments into this final determination. We address substantive comments raised by the peer reviewers concerning various aspects of the emergency and proposed rules below, and issues of a similar nature are grouped together, along with our response to each.

Issue 1: The role of habitat loss and fragmentation in the long-term decline of the Columbia Basin pygmy rabbit should be further emphasized in the final rule. In addition, measures to address habitat protection and restoration, including identifying specific habitat parameters and the control of exotic and/or invasive plant species, should be further addressed in the final rule.

Our Response: We recognize that habitat loss and fragmentation have likely played a primary role in the long-term decline of the Columbia Basin pygmy rabbit. In addition, we recognize that habitat protection and restoration will play a central role in future conservation efforts for this population. We will review and further develop specific habitat parameters and criteria, in cooperation with interested parties, at such time as we undertake future Federal conservation or recovery initiatives for the Columbia Basin pygmy rabbit.

Issue 2: The biophysical role of habitat ( e.g. , thermal cover provided by native bunch grasses), and the potential impacts to this role from livestock grazing, should be further emphasized in the final rule.

Our Response: We recognize the potential for habitat to play an important biophysical role for the Columbia Basin pygmy rabbit, and that livestock grazing may affect these habitat parameters. However, there is very little additional information available regarding this potential relationship and, until it becomes available, clarification of this issue needs further investigation.

Issue 3: An expert comment was made that our use of the terms “prehistoric”, “historic”, and “recent” be further clarified in the final rule.

Our Response: In general, use of the identified terms in the final rule is as follows: prehistoric refers to information relating to conditions greater than roughly 200 years BP ( i.e. , prior to extensive European settlement of the western United States), and recorded largely after the fact ( e.g. , paleontological records); historic refers to information relating from roughly 200 to 50 years BP, and recorded primarily in the written tradition and at the time of occurrence; and recent refers to recorded information from the previous several decades. We recognize that the use of these terms is not absolute and some overlap between them is inevitable. As possible, we have added clarity to the use of these terms in the final rule, including the use of “past” when referring to all of these time periods combined, and “current” when referring to the contemporary time frame ( i.e. , roughly the previous decade).

Issue 4: It was emphasized that plague is exotic to North American ecosystems and that native species are likely to be poorly adapted to this potential threat factor. In addition, epizootics (an outbreak of disease) in wild animals are often very difficult to detect, and disease can not easily be ruled out as a significant possible risk factor. Finally, the potential occurrence of plague in badgers from Idaho was identified, and it was suggested that disease may be implicated in other mammal declines in the Columbia Basin ( e.g. , jack rabbits).

Our Response: We concur with these clarifications and continue to consider disease a significant potential threat to the Columbia Basin pygmy rabbit.

Issue 5: It was emphasized that a successful captive propagation program should be considered extremely important for the conservation and management of the Columbia Basin pygmy rabbit's unique genetic profile.

Our Response: We concur with this clarification. We will continue to support the development of an effective captive propagation program for the Columbia Basin pygmy rabbit in order to release the species into suitable habitats within their historic range so that viable subpopulations can become established and self-sustained in the wild.

Issue 6: It was suggested that the reasoning behind identifying threat factors B, C, and D for the Columbia Basin pygmy rabbit ( see below) was somewhat circular; that is, if the population was not endangered from other, long-term causal factors (A and E), these other factors (B, C, D) would not represent current threats to the population. In addition, it was presumed that protection for the Columbia Basin pygmy rabbit under the Act could have been considered sooner to lessen the potential influences and complications of any such “secondary” threat factors.

Our Response: We are required to fully consider all five threat factors identified by the Act, regardless of whether they may be proximate or ultimate causal factors in the status of a given taxon. In addition, with regard to potential conservation and recovery efforts, identifying and controlling these more immediate threat factors is often critical to the long term security of a taxon, and consideration of longer-term conservation measures needed to ultimately achieve recovery of the taxon is often of a less urgent nature.

It is appropriate to propose a species for listing at the time when sufficient information is available. For the Columbia Basin pygmy rabbit, when we had sufficient information we took the appropriate action.

Issue 7: Concern was expressed regarding whether the emergency listing process was needed, whether it was as thorough as the Service's normal listing process, and whether there are significant differences between the two listing pathways.

Our Response: Emergency listing is appropriate when there are significant and imminent risks to the well-being of a taxon. We determined that such risks existed for the Columbia Basin pygmy rabbit primarily due to the population's extremely small size, ongoing loss and significant decline of its identified subpopulations, genetic indicators suggesting the likelihood of inbreeding depression within the population, and the unproven nature of the proposed captive breeding and subsequent reintroduction efforts for the species.

The principal differences between emergency and normal listing processes are that, under emergency listing, the Secretary may make the protective measures of the Act immediately available to the species, upon a finding of a significant risk posed to its well-being, but the listing is in force for only 240 days, and there are certain exemptions regarding the requirements of public notification and input. The 240-day expiration of an emergency listing is the primary reason we attempt to concurrently, or shortly thereafter, publish a proposed rule to list the species, as was done for the Columbia Basin pygmy rabbit, and finalize the listing as soon as possible.

Issue 8: The suggestion was made that the status of the pygmy rabbit as a monotypic genus could be a consideration regarding the potential significance of its discrete populations.

Our Response: Currently, we do not consider the status of taxa above the species level in our DPS analyses, nor is it specifically identified in the joint Service/NMFS policy addressing the recognition of DPS. However, we do consider taxonomic delineations above the species level in our priority ranking system to address the status of proposed and candidate species for potential listing actions under the Act.

Issue 9: It was emphasized that, during our DPS analyses, careful consideration should be given to the appropriateness of using the same database to address both the discreteness and significance of a population in comparison to the remainder of its taxon, especially with regard to the available genetic data.

Our Response: We concur with this clarification and recognize that, in various instances, it may be appropriate to consider the same database to address both DPS criteria. As suggested by the genetic information for the Columbia Basin pygmy rabbit presented above, we recognize that it is important to note whether the available data can be used primarily to address the isolation ( i.e. , discreteness) of a taxon's populations, the potential differentiation of a taxon's discrete populations from one another ( i.e. , significance), or as the data may relate to both criteria. In addition to the genetic information, we recognize that other sources of data, including behavioral, physiological, morphological, genetic, and ecological, may also apply to a taxon's discreteness and significance simultaneously. We will continue to address these conservation issues with regard to the pygmy rabbit throughout the species historic range as any additional information may become available.

Comments and additional data received during the comment periods, as well as further analysis on our part, raised several issues addressed in this final rule. We address these issues more specifically below.

Additional information became available as follows:

(1) The common raven is a significant potential predator of the Columbia Basin pygmy rabbit, and we also discuss WDFW's past and ongoing management efforts to address this threat factor.

(2) Vandalism has the potential to result in direct or indirect take of Columbia Basin pygmy rabbits held in captivity, and site security as an important management consideration to address this potential threat. See Summary of Factors Affecting the DPS and Available Conservation Measures sections.

(3) Washington State legislation (HB 1309) provides measures with regard to conservation of the Columbia Basin pygmy rabbit. See Summary of Factors Affecting the DPS section.

(4) Regarding the status and results of ongoing conservation and research efforts for the Columbia Basin pygmy rabbit, there is updated information concerning the WDFW's captive propagation program and research addressing the effects of livestock grazing. See Current Management Actions, Distinct Population Segment Review, and Summary of Factors Affecting the DPS sections.

(5) There is potential for a significant gap in the range of the pygmy rabbit should the Columbia Basin population segment become extirpated. This assessment helps further clarify the concept of significance as it is defined in the Act and our policy addressing the recognition of DPS. See Distinct Population Segment Review section.

(6) Control of exotic plant species is a habitat protection and restoration measure for consideration during management actions and scientific investigations. See Available Conservation Measures section.

After a thorough review and consideration of all available information, we have determined that the Columbia Basin pygmy rabbit warrants classification as an endangered DPS pursuant to the Act. We followed procedures found in section 4 of the Act and regulations promulgated to implement the listing provisions of the Act (50 CFR part 424). We may determine a DPS to be endangered or threatened due to one or more of the five factors described in section 4(a)(1). These factors and their application to the Columbia Basin pygmy rabbit ( Brachylagus idahoensis ) follow.

A. Present or threatened destruction, modification, or curtailment of habitat or range. During the first half of the 1900s, large portions of more mesic (moist) shrub steppe habitats on deeper soils within the Columbia Basin were converted for dryland crop production (Daubenmire 1988; Franklin and Dyrness 1988; WDFW 1995a). During the mid-1900s, large-scale irrigation projects led to further conversion of more xeric (dry) shrub steppe habitats on deeper soils within the Columbia Basin for irrigated agriculture (WDFW 1995a; Franklin and Dyrness 1988; U.S. Department of Interior (USDI) 1998). In addition, urban and rural developments ( e.g. , housing, industrial facilities, transportation corridors) in central Washington permanently remove native shrub steppe habitats. In 1994, it was estimated that approximately 60 percent of the original shrub steppe habitat in Washington had been converted for human uses (Dobler 1994), and shrub steppe habitats within the Columbia Basin continue to be converted for a variety of human uses. The Columbia Basin pygmy rabbit can not occupy these converted sites. Due to the small home ranges and relatively restricted movements of pygmy rabbits, conversion of native habitats in the Columbia Basin also removes or severely limits their dispersal corridors between suitable habitats.

A number of other, often interacting, influences affect the remaining native shrub steppe habitat within the Columbia Basin, including altered fire frequencies, invasion by non-native species, recreational activities, and livestock grazing. Sagebrush is easily killed by fire and, when it occurs at increased frequencies, it can remove sagebrush from the vegetation assemblage (Daubenmire 1988). In the absence of a sufficient seed source, sagebrush cannot readily reinvade sites where it has been removed, and it may be many years before it can become reestablished (WDFW 1995a). Due to a variety of factors ( see below), the fire frequency has increased over portions of the remaining shrub steppe habitat within the Columbia Basin. Because of their close association with tall, dense stands of sagebrush, pygmy rabbits are precluded from occupying frequently burned areas.

Various non-native, invasive plant species, such as cheatgrass ( Bromus tectorum ) and knapweed ( Centauria spp.), have become well established throughout the Columbia Basin (Daubenmire 1988; Franklin and Dyrness 1988). Areas with dense cover of cheatgrass are apparently avoided by pygmy rabbits in Oregon (Weiss and Verts 1984), and these newly established plant communities often provide fine fuels that can carry a fire. Combined with widespread unimproved road access and informal recreational activities that provide multiple sources of ignition, the establishment of non-native species increases the risk of fire and further reduces the security of areas that could potentially support the Columbia Basin pygmy rabbit (WDFW 1995a).

Fire was implicated in the loss of the only pygmy rabbit subpopulation ever recorded in Benton County, Washington, in 1979 (WDFW 1995a), and was directly associated with the loss of one of the few remaining subpopulations in Douglas County in 1999 (WDFW 2001b). The WDFW has taken measures to reduce the risk of fire at the Sagebrush Flat site ( e.g. , constructing firebreaks). However, unimproved road access and informal recreational activities provide a continuing source for ignition of uncontrolled fires in the area (WDFW 1995a). Due to the extremely low number of Columbia Basin pygmy rabbits in the wild, their restriction to one known site, and their reliance on relatively tall, dense stands of sagebrush, natural and human-caused fire represents a significant threat to this portion of the population.

Land managed for livestock grazing is often cleared of sagebrush to increase the production of grasses and forbs as forage for cattle (WDFW 1995a; Rauscher 1997), although this management practice in the Columbia Basin has declined from past levels (L. Hardesty, WSU, pers. comm. 2002). Clearing areas of sagebrush cover removes habitat patches potentially used by the Columbia Basin pygmy rabbit. In addition, it can reduce the value of more marginal stands of sagebrush that may act as dispersal corridors for pygmy rabbits, further fragmenting the remaining suitable habitats. Much of the remaining shrub steppe habitat in the Columbia Basin is managed for livestock grazing (WDFW 1995a; N. Hedges, pers. comm. 2001).

Excessive livestock grazing removes current herbaceous growth and residual cover of native grasses and forbs and can increase the density of various non-native, invasive species and—over several years—young sagebrush stands (Daubenmire 1988; WDFW 1995a). In some instances, this disturbance may eventually result in the growth of tall, dense stands of sagebrush (Daubenmire 1988), potentially improving the shrub forage and cover conditions for pygmy rabbits. However, livestock grazing at these levels potentially reduces the forage base and cover characteristics of grasses and forbs for Columbia Basin pygmy rabbits (Green and Flinders 1980b; Rauscher 1997). Excessive livestock grazing may also cause structural damage to dense stands of older sagebrush. This acts to open the canopies of these sites and potentially makes them less suitable as cover for Columbia Basin pygmy rabbits (Gahr 1993; Rauscher 1997). Currently, it is unclear if light or moderate levels of livestock grazing may be compatible with pygmy rabbit conservation efforts over the long-term.

There are several past and ongoing studies that have investigated the effects of different livestock grazing strategies on Columbia Basin pygmy rabbits and their habitat (Gahr 1993; WDFW 1995a; Sayler et al. 2001; L. Shipley, pers. comm. 2001). Gahr (1993) found that male pygmy rabbits at the Sagebrush Flat site made longer movements during the breeding season, resulting in larger home ranges, in recently grazed areas as opposed to areas that had not been grazed for nearly 40 years. In addition, relative to unit size, there are more pygmy rabbit burrows in the ungrazed areas of Sagebrush Flat than the recently grazed areas (L. Shipley, pers. comm. 2001). Further evaluation of the distribution and availability of appropriate soils across the Sagebrush Flat site will help clarify these results. Nevertheless, they suggest that Columbia Basin pygmy rabbits may be more susceptible to predation in areas used for livestock grazing due to longer movements away from cover and fewer burrows available for escape.

Results of an ongoing study also indicate that Columbia Basin pygmy rabbits occupying grazed sites tend to have a greater proportion of their summer through winter diets composed of sagebrush as opposed to grasses and forbs (L. Shipley, pers. comm. 2001). In addition, the nutritional quality ( e.g. , less protein and greater fiber content) of the available grasses and shrubs in recently grazed sites tends to be less from fall through spring (L. Shipley, pers. comm. 2002). These results provide support for the contention that livestock may compete directly with pygmy rabbits for available forage during these periods (Green and Flinders 1980b; Rauscher 1997). There is also evidence that cattle can directly damage pygmy rabbit burrow systems through trampling (Rauscher 1997; N. Siegel, WSU, pers. comm. 2001; M. Hallet, pers. comm. 2002). These impacts may be especially critical during the Columbia Basin pygmy rabbits' reproductive period.

Populations of pygmy rabbits have coexisted with various levels of livestock grazing activities throughout their historic range for many years (WDFW 1995a). However, due to the extremely low number and restricted distribution of Columbia Basin pygmy rabbits, any additional mortality or population stress associated with livestock grazing practices represents a significant threat to the security of the wild portion of this population segment.

Due to the combined influences described above, Washington's native shrub steppe habitats, including those considered essential to the long-term security of the Columbia Basin pygmy rabbit, are considered among the least protected areas in the State (Cassidy 1997).

B. Over-utilization for commercial, recreational, scientific, or educational purposes. Pygmy rabbits are often difficult to distinguish from species of cottontail rabbits ( Sylvilagus spp.) (Garber 1993; WDFW 1995a). Because of this, accidental shooting of Columbia Basin pygmy rabbits may occur in association with hunting of other small game species in Washington (WDFW 1979). Due to their extremely low numbers, restricted distribution, and preference for dense habitats, combined with relatively few small game hunters at the Sagebrush Flat site, the risk from accidental shooting of Columbia Basin pygmy rabbits is currently considered relatively low (WDFW 1995a; D. Hays, pers. comm. 2001). However, in such reduced populations, accidental shooting could become a significant source of mortality if it is not carefully controlled.

Investigations that require trapping, handling, and captivity of pygmy rabbits can result in mortality from several causes, including exposure (due to excessively high or low temperatures); direct injury from entanglement in traps, trap predation, and intra-specific fighting; and capture stress (Bailey 1936; Severaid 1950; Wilde 1978; Gahr 1993; Rauscher 1997). Capture-related mortality rates (including recaptures) reported for pygmy rabbits are roughly 3 percent (Gahr 1993), 5 percent (Wilde 1978), and 13 percent (Rauscher 1997). The mortality rate for one study approached 20 percent when the total number of captured animals was considered (11 deaths of 58 individuals), and all of the mortalities in this study occurred in just one portion of the study area (Rauscher 1997). Trapping methods, daily and seasonal timing, study location, holding facilities and site security, and husbandry techniques may all affect the level of capture-related mortality incurred. In addition, vandalism of captive rearing facilities remains a threat following capture (L. Hardesty, pers. comm. 2002).

Currently, the WDFW is leading efforts to establish a captive breeding population of Columbia Basin pygmy rabbits ( see Current Management Actions, above). To date, three capture-related deaths have occurred in this program. These deaths represent roughly a 14 percent mortality rate for the captured animals (3 of 21 individuals). While the captive propagation program is necessary to help ensure the long-term survival of the Columbia Basin pygmy rabbit, and we support these efforts, the potential for capture-related mortality to significantly affect the success of this program remains.

Some pygmy rabbit burrows are relatively shallow and may collapse when walked on by humans (Wilde 1978). Investigations of pygmy rabbits often entail the destruction of individual burrows, while measuring of the vegetation community and other site characteristics immediately surrounding burrow systems, and/or disturbance to the general area occupied by the pygmy rabbits (Janson 1946; Bradfield 1974; Green 1978; Wilde 1978; Gahr 1993; Gabler 1997; Rauscher 1997). Furthermore, various ongoing management and maintenance activities of the WDFW at the Sagebrush Flat site ( e.g. , establishment of firebreaks, species and habitat surveys, fencing removal or construction) have the potential to directly or indirectly affect the Columbia Basin pygmy rabbit.

It is unlikely that any of the above activities alone has played a significant role in the long-term population decline and range reduction of the Columbia Basin pygmy rabbit. However, due to the current vulnerability of both the wild and captive portions of this population segment, any additional source of mortality may now play a significant role and could impair efforts to conserve the Columbia Basin pygmy rabbit.

C. Disease or predation. Pygmy rabbits often harbor a high parasite load (Gahr 1993; WDFW 1995a). Some of the parasites of pygmy rabbits, including ticks, fleas, and lice, can be vectors of disease. Episodes of plague and tularemia from these vectors have been reported in populations of a number of other Leporid species and are often fulminant (rapidly spreading) and fatal (Quan 1993). Severe disease epidemics have not been reported in pygmy rabbits, and parasites have not been viewed as a significant threat to the species (Green 1979; Gahr 1993). However, evidence of plague was reported in a coyote taken from the site of one of the recently extirpated subpopulations of Columbia Basin pygmy rabbits (WDFW 2001a). The potential occurrence of plague in this subpopulation is being investigated using blood samples obtained prior to its extirpation (D. Hays, pers. comm. 2001). Additional studies have been proposed to investigate the occurrence of plague and other diseases, and their possible control, in wild and captive populations of pygmy rabbits (C. Brand, National Wildlife Health Center, pers. comm. 2001). Because so few Columbia Basin pygmy rabbits remain, the potential for disease outbreak represents a significant threat to both the wild and captive portions of this population segment.

Predation is thought to be a major cause of mortality among pygmy rabbits (Green 1979; Wilde 1978). However, pygmy rabbits have adapted to the presence of a wide variety of avian and terrestrial predators that occur throughout their historic distribution (Janson 1946; Gashwiler et al. 1960; Green 1978; Wilde 1978; WDFW 1995a). In relatively large, well distributed pygmy rabbit populations, predation is not likely to represent a significant threat to their long-term security. In contrast, due to the extremely small size and localized occurrence of the Columbia Basin pygmy rabbit population, altered predation patterns, or even natural levels of predation, currently represent a significant threat to both the wild and captive portions of this population segment and could impair ongoing conservation efforts.

Due to confirmed evidence of coyote predation on the Columbia Basin pygmy rabbit, the WDFW implemented a predator control program during the fall-winter periods of 1998-1999 and 1999-2000 (WDFW 2000a). Numerous coyotes and several long-tailed weasels were removed, by shooting, traps, or snares, over roughly 52 square kilometers (20 square miles) around and including the Sagebrush Flat site. The level of effort to control terrestrial predators varied among years and areas, and the efficacy of this program to protect the Columbia Basin pygmy rabbit is unknown. There are also a variety of avian predators that may occur at the Sagebrush Flat site. In an effort to help control the occurrence of common ravens and other predatory birds, the WDFW recently removed two obsolete windmills from the area that could have potentially been used as perching or nesting sites (M. Hallet, pers. comm. 2002).

Because of the relatively restricted distribution of the Columbia Basin pygmy rabbit, terrestrial and avian predators may also have a reduced search area and/or increased success rate at the Sagebrush Flat site. To further address the threat of predation on the Columbia Basin pygmy rabbit, additional measures are being considered by the WDFW for this area, such as controlling artificial food sources ( e.g. , spilled grain, trash, carnivore baits), the removal of unnecessary fencing potentially used as perch sites for avian species, and providing appropriate predator exclusion fencing (M. Hallet, pers. comm. 2002; D. Hays, pers. comm. 2002).

Several measures ( e.g. , double fencing, monitoring) have been taken to reduce the risk of predation on the captive portion of the Columbia Basin pygmy rabbit population (R. Sayler, WSU, pers. comm. 2001; L. Shipley, pers. comm. 2001). In addition, captive animals are currently being held at multiple facilities, which reduces the risk of catastrophic loss at a single facility (D. Hays, pers. comm. 2002). However, while the risk has been greatly reduced, the potential for certain predators to access cages at the captive rearing facilities remains.

Due to the extremely small size of the Columbia Basin pygmy rabbit population, even low levels of predation represent a significant risk to the immediate security of both the wild and captive portions of this population segment.

D. Inadequacy of existing regulatory mechanisms. Washington State classification of the Columbia Basin pygmy rabbit as endangered makes it illegal to attempt to kill, injure, capture, harass, possess, or control individuals of the species (WDFW 1995a). However, illegal or accidental shooting of Columbia Basin pygmy rabbits may occur in association with hunting seasons for other small game species ( see factor C above). In addition, State designation does not provide regulatory protection of the habitats considered essential to the long-term security of the Columbia Basin pygmy rabbit.

Pursuant to Washington State legislation passed in 1993 (HB 1309), the Washington State Conservation Commission (WSCC) oversaw the development and provided approval of ecosystem standards for State-owned agricultural and grazing lands (WSCC 1995). HB 1309 called for implementation of the ecosystem standards to maintain and restore fish and wildlife habitat within the State by improving overall ecosystem health. The standards developed under HB 1309 are mandated for lands under the jurisdiction of the WDFW and Washington Department of Natural Resources (WDNR). Application of the standards on lands managed by the WDNR must be consistent with the agency's fiduciary obligations.

Currently, we are assisting private landowners with development of a county-wide HCP to protect important plant and animal species on agricultural lands in Douglas County. However, there are no regulatory protections for unlisted species during development of HCPs. Revegetation standards under the CRP promote the improvement of habitats potentially used by the Columbia Basin pygmy rabbit, and the CRP restricts livestock grazing on contract lands except under severe drought conditions (M. Ruud, Farm Service Agency, pers. comm. 2001).

E. Other natural or human-caused factors affecting the species' continued existence. The immediate concerns for the Columbia Basin pygmy rabbit are associated with the population's extremely small size, history of fragmentation and extirpation, and the recent, dramatic decline in its distribution and abundance. Small populations are susceptible to random environmental events ( e.g. , severe storms, prolonged drought, extreme cold spells, volcanic fallout), abrupt changes in cover and food resources, altered predator or parasite populations, disease outbreaks, and fire. Small populations are also more susceptible to demographic and genetic problems (Shaffer 1981). These threat factors, which may act in concert, include natural variation in survival and reproductive success of individuals, chance disequilibrium of sex ratios, changes in gene frequencies due to genetic drift, and lack of genetic diversity caused by inbreeding.

Genetic indices indicate that the Columbia Basin pygmy rabbit had less genetic diversity historically than the remainder of the taxon. In addition, this population segment has undergone further loss of genetic diversity since roughly the mid-1900s. Severe loss of genetic diversity may make the Columbia Basin pygmy rabbit more susceptible to extinction due to inbreeding depression or, assuming inappropriate introduction of other pygmy rabbit genes, swamping of their unique genetic profile. Reduced genetic diversity, and the relatively few family lineages remaining in the Columbia Basin pygmy rabbit population, may also complicate captive breeding strategies conducted to reestablish a minimum effective population size. Ultimately, an appropriate effective population size will help ensure the maintenance and enhancement of the genetic heterogeneity that is still present within this population segment (K. Warheit, pers. comm. 2001, 2002).

In relatively large, well distributed pygmy rabbit populations, the above threats are not likely to represent a significant risk to their long-term security. However, due to the extremely small size and localized occurrence of both the wild and captive portions of the Columbia Basin pygmy rabbit population, these threats represent a significant risk to the long-term security of this DPS.

Due to the combined influence of the above threats, extirpation of the Columbia Basin pygmy rabbit from the wild may occur at any time (WDFW 2001b). In addition, the risks to the captive portion of the population, and the potential for extinction of the Columbia Basin pygmy rabbit, remain high. We have carefully assessed the best scientific and commercial information available regarding the past, present, and potential future threats faced by the Columbia Basin pygmy rabbit. Based on our evaluation of the five threat factors discussed above, we have determined that the Columbia Basin pygmy rabbit is in danger of extinction. As such, we are listing the Columbia Basin pygmy rabbit as endangered.

Critical habitat is defined in section 3 of the Act as: (i) The specific area within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features (I) essential to the conservation of the species, and (II) that may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed, in accordance with the provisions of section 4 of the Act, upon a determination by the Secretary that such areas are essential for the conservation of the species. “Conservation” means the use of all methods and procedures needed to bring the species to the point at which listing under the Act is no longer necessary.

Section 4(a)(3) of the Act, as amended, and its implementing regulations (50 CFR 424.12) require that, to the maximum extent prudent and determinable, we designate critical habitat at the time the species is determined to be endangered or threatened. Our implementing regulations (50 CFR 424.12(a)) state that critical habitat is not determinable if information sufficient to perform the required analyses of impacts of the designation is lacking, or if the biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat. Section 4(b)(2) of the Act requires us to consider economic and other relevant impacts of designating a particular area as critical habitat on the basis of the best scientific data available. We may exclude any area from critical habitat if we determine that the benefits of such exclusion outweigh the conservation benefits, unless to do so would result in the extinction of the species.

We find that designation of critical habitat for the Columbia Basin pygmy rabbit is not determinable at this time because information sufficient to perform the required analyses of the impacts of the designation is lacking. We specifically solicited information on potential critical habitat, biological information, and information that would aid our prudency analysis in our proposed rule. We received no comments regarding specific physical or biological features essential to the Columbia Basin pygmy rabbit which provided information that added to our ability to determine critical habitat. In addition, the extent of habitat essential to the conservation of the species has not been identified. When a “not determinable” finding is made, we must, within 2 years of the publication date of the original proposed rule, designate critical habitat, unless the designation is found to be not prudent.

We will continue to protect the Columbia Basin pygmy rabbit and its habitat through section 7 consultations to determine whether Federal actions may affect this population segment, through the recovery process, through HCPs and through enforcement of the Act's “take” prohibitions ( see 16 U.S.C. 1538; 50 CFR 17.21).

Conservation measures provided to species listed as endangered or threatened under the Act include recognition, requirements for Federal protection, prohibitions against certain activities, and development of recovery plans. Recognition through listing results in public awareness and encourages conservation actions by Federal, State, and Tribal agencies, non-governmental conservation groups, and private individuals. The Act provides for possible land acquisition and cooperation with the States, and requires that recovery actions be carried out for listed species. The protection required of Federal agencies, and the prohibitions against certain activities involving listed species are discussed, in part, below.

Section 7(a) of the Act, as amended, requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened, and with respect to its critical habitat, if any is being designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) requires Federal agencies to confer with us on any action that is likely to jeopardize the continued existence of a species proposed for listing, or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, section 7(a)(2) requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat, if any has been designated. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into formal consultation with us.

Federal agencies, whose actions may require consultation for the Columbia Basin pygmy rabbit include, but are not limited to, those within the jurisdictions of the Service, BLM, Bureau of Reclamation, Natural Resources Conservation Service, and Farm Service Agency. In addition, activities that are authorized, funded, or administered by Federal agencies on non-Federal lands will be subject to section 7 review.

We believe that protection and recovery of the Columbia Basin pygmy rabbit will require reduction of the threats from uncontrolled fire, altered predation patterns, excessive livestock grazing, disease outbreaks, mortality associated with the captive propagation and release programs, and loss of genetic viability. These threats should be considered for management actions in habitats currently and potentially occupied by the Columbia Basin pygmy rabbit, and those deemed important for dispersal between their appropriate use areas. Monitoring should also be undertaken for any management actions or scientific investigations designed to address these threats or their potential impacts.

Listing the Columbia Basin pygmy rabbit as endangered provides for the development and implementation of a recovery plan for the population. This plan will bring together Federal, State, tribal, and local efforts for conservation of the species, and will establish a framework for interested parties to coordinate recovery efforts. The plan will set recovery priorities, assign responsibilities, and estimate the costs of the various tasks necessary to achieve conservation and survival of the species. Additionally, pursuant to section 6 of the Act, we will be able to grant funds to the State of Washington for management actions promoting the protection and recovery of this species.

Considerations for management actions and scientific investigations to address the above threats to the Columbia Basin pygmy rabbit include, but are not limited to:

(1) Fire —implementation of agreements between fire-fighting districts and/or agency departments to provide adequate coverage, construction of fire breaks, availability of fire-fighting equipment, fire-fighting techniques, weed control, use of prescribed fire, and removal or restriction of unimproved road access and informal recreational activities;

(2) Livestock Grazing —season(s) of use, stocking rate(s) and type(s), location of supplemental water and salt/minerals, loading and transport facilities, exclusion fencing, and removal;

(3) Habitat Protection and Restoration —control of exotic and/or invasive plant species, planting types and techniques, soils and hydrologic analyses, land acquisition and connectivity, and control of unauthorized access.

(4) Predation —identification of primary predators and predation patterns, development of protocols for fence removal and/or new fence construction, and predator deterrents and/or lethal control of predators to protect the wild and captive portions of the population;

(5) Disease —identification and control of potential disease and disease vectors in wild and captive portions of the population;

(6) Capture, husbandry, and reintroduction —development of protocols for survey, capture, handling, and husbandry techniques; maintenance and security of multiple holding facilities for captive stock; inventory and evaluation of appropriate release sites; and development of release and site maintenance protocols; and

(7) Genetics —identification of additional genetic markers, implementation of appropriate breeding scenarios, and establishment of a minimum effective population for captive breeding and reintroduction efforts.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered wildlife. The prohibitions of section 9 of the Act, codified at 50 CFR 17.21, in part, make it illegal for any person subject to the jurisdiction of the United States to take (including harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, collect, or attempt any such conduct), import or export, transport in interstate or foreign commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to our agents and State conservation agencies.

Permits may be issued to carry out otherwise prohibited activities involving listed species under certain circumstances. Such permits are available for scientific purposes, to enhance the propagation or survival of the species, or for incidental take in connection with otherwise lawful activities.

It is our policy, published in the Federal Register on July 1, 1994 (59 FR 34272), to identify, to the maximum extent practical, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of the listing on proposed and ongoing activities within the species' range. For the Columbia Basin pygmy rabbit, based upon the best available information, we believe the following actions are unlikely to result in a violation of section 9, provided these activities are carried out in accordance with existing regulations and permit requirements:

(1) Possession, delivery, or movement, including interstate transport and import into or export from the United States of dead specimens of Columbia Basin pygmy rabbits that were collected prior to the date of publication of the emergency listing rule in the Federal Register ;

(2) Any action authorized, funded, or carried out by a Federal agency that may affect the Columbia Basin pygmy rabbit ( e.g. , land exchanges, land clearing, prescribed burning, livestock grazing, pest control, utility line or pipeline construction, mineral extraction or processing, housing developments, off-road vehicle use, recreational trail or campground development, road construction, shooting, poisoning, habitat conversion, road construction, water development and impoundment, unauthorized application of herbicides or pesticides in violation of label restrictions) when the action is conducted in accordance with an incidental take statement issued under section 7 of the Act;

(3) Any action carried out for scientific research or to enhance the propagation or survival of the Columbia Basin pygmy rabbit that is conducted in accordance with the conditions of a section 10(a)(1)(A) permit under the Act; and

(4) Any incidental take of the Columbia Basin pygmy rabbit resulting from an otherwise lawful activity conducted in accordance with the conditions of an incidental take permit issued under section 10(a)(1)(B) of the Act.

Activities that we believe could potentially result in a violation of section 9 include, but are not limited to:

(1) Unauthorized possession, trapping, handling, collecting, or release of pygmy rabbits within the historic range of the Columbia Basin pygmy rabbit. Research efforts involving these activities will require a permit under section 10(a)(1)(A) of the Act;

(2) Other activities that actually kill or injure a Columbia Basin pygmy rabbit by significantly impairing essential behavioral patterns (such as breeding, feeding or sheltering) through significant habitat modification or degradation ( e.g. , via land clearing, prescribed burning, habitat conversions, over-grazing or trampling by livestock, pest control, minerals extraction or processing, housing developments, off-road vehicle use, recreational trail or campground development, shooting, intentional poisoning, road construction, water development and impoundment, unauthorized application of herbicides or pesticides in violation of label restrictions). Otherwise lawful activities that incidentally take a Columbia Basin pygmy rabbit will require a permit under section 10(a)(1)(B) of the Act.

Questions regarding whether specific activities risk violating section 9 should be directed to our Upper Columbia Fish and Wildlife Office ( see ADDRESSES section). Requests for copies of the regulations on listed wildlife, including general inquiries regarding prohibitions and issuance of permits under the Act, may be addressed to the U.S. Fish and Wildlife Service, Ecological Services, Endangered Species Permits, 911 NE. 11th Avenue, Portland, Oregon 97232-4181 (telephone 503/231-2063; facsimile 503/231-6243).

The emergency listing that protected the Columbia Basin pygmy rabbit for 240 days expired on July 29, 2002. The threats to the species remain imminent and severe. Because of the extremely small size of the only remaining wild population, and the expiration of its interim protection, we find that good cause exists for this rule to take effect immediately upon publication in accordance with 5 U.S.C. 553(d)(3).

We have determined that environmental assessments and environmental impact statements, as defined in the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Endangered Species Act of 1973, as amended. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

This rule does not contain any new collections of information that require approval by Office of Management and Budget (OMB) under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). This rule will not impose record keeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The existing OMB control number is 1018-0094 and expires July 31, 2004.

On May 18, 2001, the President issued an Executive Order on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires Federal agencies to prepare Statements of Energy Effects when undertaking certain actions. This final rule is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.

A complete list of references cited herein is available upon request from the Upper Columbia Fish and Wildlife Office ( see ADDRESSES section).

The primary author of this final rule is Christopher Warren of the Upper Columbia Fish and Wildlife Office ( see ADDRESSES section).