Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended (NWPA), requires that “[t]he Secretary [of the Department of Energy (DOE)] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under section 218(a) for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the NRC approved dry storage of spent nuclear fuel in NRC-approved casks under a general license, publishing a final rule in 10 CFR part 72 entitled, “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new Subpart L within 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” containing procedures and criteria for obtaining NRC approval of dry storage cask designs.

The NRC subsequently issued a final rule on December 22, 1994 (59 FR 65898) that approved the Standardized NUHOMS® storage system and added it to the list of NRC-approved cask designs in § 72.214, as CoC No. 1004. Amendment No. 1 to CoC No. 1004 was issued on March 28, 2000 (65 FR 16299).

The certificate holder (Transnuclear West, Inc.) submitted an application to the NRC on February 16, 1996, supplemented on November 15, 1996, October 9, 1998, and February 10, 1999, to amend CoC No. 1004 to include a new fuel specification and on July 26, 1999, to amend CoC No. 1004 to permit a part 72 licensee to store BPRAs.

The first change permits a part 72 licensee to store spent fuel in the NUHOMS® storage system using the new fuel qualification tables. The particular changes are incorporated into section 1.2.1 of the Technical Specifications for CoC No. 1004. The changes will incorporate new fuel qualification tables for both pressurized water reactor (PWR) and boiling water reactor (BWR) fuel. The tables present the minimum required cooling time for fuel as a function of the initial fuel enrichment and fuel burnup. The use of the tables provides a simplified approach for users of the NUHOMS® storage system to select fuel for storage without calculating specific fuel assembly decay heat and radiation source terms.

The NRC agrees that this direct final rule provides a more simplified, accurate, and straightforward method for qualifying fuel to be stored in the NUHOMS® storage system and has documented its review and evaluation in a Safety Evaluation Report (SER) regarding use of new fuel qualification tables.

The second change permits a part 72 licensee to store BPRAs with Babcock & Wilcox (B&W) 15 x 15 spent fuel assemblies in the NUHOMS® storage system model 24P. A BPRA is a reactor core component that is inserted inside a fuel assembly. BPRAs provide a means of controlling reactor power distribution and do not contain fissile material. No other changes to the TN-West system design were requested in this application. The NRC staff performed a safety evaluation of this proposed CoC amendment request and found that the addition of the BPRAs to the B&W 15 x 15 fuel does not reduce the TN-West safety margin. In addition, the NRC staff has determined that the storage of BPRAs in the TN-West does not pose any increased risk to public health and safety. This is documented in a SER concerning the BPRA change.

The amended TN-West cask system, when used in accordance with the conditions specified in the CoC, the Technical Specifications, and NRC regulations, will meet the requirements of part 72; thus, adequate protection of public health and safety will continue to be ensured. Currently, the CoC is approved only for storage of spent fuel assemblies.

Amendment No. 2 to CoC No. 1004, the revised Technical Specifications, the underlying Safety Evaluation Reports (SERs) for the amendment and the Environmental Assessment, are available for inspection at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. Single copies of the CoC and SERs may be obtained from Stephanie P. Bush-Goddard, Ph.D., Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6257, email SPB@nrc.gov.

Certificate No. 1004 will be revised indicating the addition of Amendment No. 2 with an effective date of September 5, 2000.

This rule is limited to the changes contained in Amendment No. 2 to CoC No. 1004 and does not include other aspects of the Standardized NUHOMS®-24P and NUHOMS®-52B cask system design. Because NRC considers this amendment to its rules to be noncontroversial and routine, the NRC is using the direct final rule procedure for this rule. The amendment to the rules will become effective on September 5, 2000. However, if the NRC receives significant adverse comments on the associated proposed rule published concurrently in the proposed rules section of this Federal Register by July 24, 2000, then the NRC will publish a notice that withdraws this action and will address the comments received in response to the proposed amendments. These comments will be addressed in a subsequent final rule. Absent significant modifications to the proposed changes requiring republication, the NRC will not initiate a second comment period on this action.

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 (AEA), 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 Federal 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.

Under the National Environmental Policy Act of 1969, as amended, and the NRC regulations in subpart A of 10 CFR part 51, the NRC has determined that this rule is not a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The rule will amend the CoC for the NUHOMS® storage system within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. The amendment will add new fuel qualification tables to the technical specifications and add BPRAs to the authorized contents of the NUHOMS® system model 24P. The environmental assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment and finding of no significant impact are available from Stephanie P. Bush-Goddard, Ph.D., Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6257, email SPB@nrc.gov.

This direct final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget, Approval Number 3150-0132.

If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

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 would revise the Transnuclear West, Inc., Standardized NUHOMS® cask system listing within the list of NRC approved casks for spent fuel storage in § 72.214. This action does not constitute the establishment of a standard that establishes generally-applicable requirements.

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask system designs approved by the NRC. Any nuclear power reactor licensee can use NRC-certified casks to store spent nuclear fuel if it notifies the NRC in advance, spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On December 22, 1994 (59 FR 65898), the NRC issued an amendment to part 72 that approved the Standardized NUHOMS® storage system designs by adding them to the list of NRC-approved cask designs in § 72.214. The NRC subsequently issued Amendment No. 1 to CoC No. 1004 on March 28, 2000 (65 FR 16299). The certificate holder (Transnuclear West, Inc.) submitted an application to the NRC on February 16, 1996, supplemented on November 15, 1996, October 9, 1998, February 10, 1999 and July 26, 1999 to amend CoC No. 1004 to include new fuel specification tables and to add BPRAs to the authorized contents of the NUHOMS® storage system. The proposed new fuel specification tables in Amendment No. 2 provides a simplified method for determining acceptable spent fuel to be stored in the NUHOMS® storage system and will add BPRAs as authorized contents of the NUHOMS® storage system model 24P that are currently only for storage of spent fuel assemblies.

The alternative to Amendment 2 is to withhold approval of this amended cask system design. This alternative would require users of the NUHOMS® storage system to use a less efficient method for selecting fuel for storage and would also require users to bear the additional costs of disassembling BPRA's from the spent fuel assemblies and of storing them as low-level waste.

Approval of the direct final rule will eliminate the problems described above and is consistent with previous Commission actions. Further, the direct final rule will have no adverse effect on public health and safety. This direct final rule has no significant identifiable impact or benefit on other Government agencies.

Based on the above discussion of the benefits and impacts of the alternatives, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and thus, this action is recommended.

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.

In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. This direct final rule affects only the operation of nuclear power plants, independent spent fuel storage facilities, and TN-West. The companies that own these plants do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the Small Business Size Standards set out in regulations issued by the Small Business Administration at 13 CFR part 121.

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

Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended (NWPA), requires that “[t]he Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under section 218(a) for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the NRC approved dry storage of spent nuclear fuel in NRC-approved casks under a general license, publishing a final rule, in 10 CFR part 72 entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181, July 18, 1990). This rule also established a new Subpart L within 10 CFR part 72 entitled “Approval of Spent Fuel Storage Casks,” containing procedures and criteria for obtaining NRC approval of dry storage cask designs.

The NRC subsequently issued a final rule on April 7, 1993 (58 FR 17948), that approved the VSC-24 cask design, added it to the list of NRC-approved cask designs in § 72.214, and issued Certificate of Compliance Number (CoC No.) 1007.

On November 20, 1998, PSNA (the certificate holder), submitted an application to the NRC to amend CoC No. 1007 to revise the Technical Specifications and CoC regarding welding and nondestructive examination of welds, the method for determining cask drain time during loading, the minimum temperature for moving the loaded multi-assembly sealed basket (MSB), artificial thermal loads other than spent fuel that may be used to obtain temperature data, and the maximum permissible air outlet temperature. In addition, the amendment includes changes to the Technical Specifications and CoC to correct typographical errors and to make other minor clarifications and changes. These changes are described in the Revision History for Amendment 2 (CoC, Attachment A, pages iii and iv). The staff performed a safety evaluation of the amendment request and found that the changes provide reasonable assurance that the spent fuel can be stored safely and in compliance with 10 CFR Part 72. The staff documented its review and evaluation in a Safety Evaluation Report. A separate amendment request (submitted December 30, 1998) to permit a Part 72 licensee to store burnable poison rod assemblies (BPRAs) in the VSC-24 cask design along with the spent fuel is being addressed in a separate rulemaking.

This direct final rule will revise the PSNA VSC-24 cask system listing within the list of NRC-approved casks for spent fuel storage in § 72.214 by adding Amendment No. 2 to CoC No. 1007. The amended VSC-24 cask system, when used in accordance with the conditions specified in the CoC and NRC regulations, will meet the requirements of 10 CFR Part 72; thus, adequate protection of public health and safety will continue to be ensured. Amendment No. 2 applies to any VSC-24 cask loaded after September 5, 2000.

Amendment No. 2 to CoC No. 1007 and the underlying SER, and the Environmental Assessment and Finding of No Significant Impact are available for inspection and comment at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. Single copies of the CoC and SER may be obtained from Gordon Gundersen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6195, email GEG1@nrc.gov.

Certificate No. 1007 will be revised indicating the addition of Amendment No. 2 and its effective date.

This rule is limited to the changes contained in Amendment No. 2 to CoC 1007 and does not include other aspects of the VSC-24 cask system design. Because NRC considers this amendment to its rules to be noncontroversial and routine, the NRC is using the direct final rule procedure for this rule. The amendment to the rules will become effective on September 5, 2000. However, if the NRC receives significant adverse comments on the associated proposed rule notice published concurrently in the proposed rules section of this Federal Register by July 24, 2000, then the NRC will publish a document that withdraws this action and will address the comments received in response to the amendments. These comments will be addressed in a subsequent final rule. Absent significant modification to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

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 (AEA) 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 will revise the PSNA VSC-24 cask system listing within the list of NRC approved casks for spent fuel storage in 10 CFR 72.214. This action does not constitute the establishment of a standard that establishes generally-applicable requirements.

Under the National Environmental Policy Act of 1969, as amended, and the NRC regulations in Subpart A of 10 CFR Part 51, the NRC has determined that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The rule will add Amendment No. 2 to the VSC-24 cask system to the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites without additional site-specific approvals by the NRC. The amendment will revise the Technical Specifications and CoC regarding welding and nondestructive examination of welds, the method for determining cask drain time during loading, the minimum temperature for moving the loaded MSB, artificial thermal loads other than spent fuel that may be used to obtain temperature data, and the maximum permissible air outlet temperature. In addition, the amendment includes changes to correct typographical errors and other minor clarifications and changes. The environmental assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment and finding of no significant impact are available from Gordon Gundersen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone (301) 415-6195, email GEG1@nrc.gov.

This direct final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget, Approval Number 3150-0132.

If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR Part 72 to provide for the storage of spent nuclear fuel under a general license in cask system designs approved by the NRC. Any nuclear power reactor licensee can use NRC-certified casks to store spent nuclear fuel if it notifies the NRC in advance, spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met.

A list of NRC-approved cask system designs is contained in § 72.214. On April 7, 1993 (58 FR 17948), the NRC issued an amendment to part 72 that approved the VSC-24 cask design, added it to the list of NRC-approved cask designs in § 72.214, and issued CoC No. 1007. On November 20, 1998, the certificate holder submitted an application to the NRC to amend CoC No. 1007 to revise the Technical Specifications and CoC regarding welding and nondestructive examination of welds, the method for determining cask drain time during loading, the minimum temperature for moving the loaded MSB, artificial thermal loads other than spent fuel that may be used to obtain temperature data, and the maximum permissible air outlet temperature. In addition, the amendment includes changes to the Technical Specifications and CoC to correct typographical errors and to make other minor clarifications and changes.

This rule will permit manufacture of casks under the revisions in Amendment 2. The alternative to this action is to withhold approval of this amended cask system design and give a site-specific license to each utility that proposes to use the casks. This alternative would cost both the NRC and the utilities more time and money in that each utility would have to pursue a new site-specific license. Conducting site-specific reviews would be in conflict with NWPA direction to the NRC to approve technologies for the use of spent fuel storage at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the NRC. This alternative does not foster competition because it would tend to favor new vendors without cause and would arbitrarily limit the choice of cask system designs available to power reactor licensees.

Approval of the direct final rule would eliminate the above problems and is consistent with previous NRC actions. Further, the direct final rule will have no adverse effect on public health and safety. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on the above discussion of the benefits and impacts of the alternatives, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and thus, this action is recommended.

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.

In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. This direct final rule affects only the licensing and operation of nuclear power plants, independent spent fuel storage facilities, and PSNA. The companies that own these plants do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the Small Business Size Standards set out in regulations issued by the Small Business Administration at 13 CFR part 121.

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

This amendment to 14 CFR 71 revises the Class E airspace at Pratt, KS. A review of the Class E airspace for Pratt Municipal Airport, KS, indicates it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2D. The criteria in FAA Order 7400.2D for an aircraft to reach 1200 feet AGL is based on a standard climb gradient of 200 feet per miles plus the distance from the Airport Reference Point (ARP) to the end the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. The amendment at Pratt Municipal Airport, KS, will provide additional controlled airspace for aircraft operating under IFR, and comply with the criteria of FAA Order 7400.2D. 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 7400.9G, dated September 10, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in 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. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. 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 published 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.

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-14.” The postcard will be date stamped and returned to the commenter.

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

The FAA has determined that this regulation is 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.

This amendment to 14 CFR 71 revises the Class E airspace at Coffeyville, KS. A review of the Class E airspace for Coffeyville Municipal Airport, KS, indicates it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2D. The criteria in FAA Order 7400.2D for an aircraft to reach 1200 feet AGL is based on a standard climb gradient of 200 feet per mile plus the distance from the Airport Reference Point (ARP) to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. The amendment at Coffeyville Municipal Airport, KS, will provide additional controlled airspace for aircraft operating under IFR, revise the ARP and comply with the criteria of FAA Order 7400.2D. 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 7400.9G, dated September 10, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation 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. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. 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.

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-15.” The postcard will be date stamped and returned to the commenter.

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

The FAA has determined that this regulation is 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 March 14, 2000, the FAA published a proposal in the Federal Register , to amend the East Coast Low Airspace Area (65 FR 13705). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. In response to the notice, the FAA received no comments on this action. Except for editorial changes, this rule is the same as that proposed in the notice.

This action amends 14 CFR part 71 by modifying the East Coast Low Airspace Area. This action extends the present airspace boundaries further east, south, and southwest of the Nantucket Airport and lowers the controlled floor in this area to 2,000 feet MSL. This modification will provide additional airspace to allow for more efficient control of Nantucket Airport arrivals and departures.

Offshore airspace area designations are published in paragraph 6007 of FAA Order 7400.9G, which is dated September 1, 1999, and was effective on September 16, 1999. FAA Order 7400.9G is incorporated by reference in 14 CFR 71.1. The offshore airspace area described in this document will be published 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.

Since part of this rule effects navigable airspace outside the United States, the notice of proposed rulemaking was submitted to the Department of State and the Department of Defense in accordance with the ICAO International Standards and Recommended Practices.

The application of International Standards and Recommended Practices by the FAA, Office of Air Traffic Airspace Management, in areas outside U.S. domestic airspace, is governed by the Convention on International Civil Aviation. Specifically, the FAA is governed by Article 12 and Annex 11 of the Convention, which pertain to the establishment of necessary air navigational facilities and services to promote the safe, orderly, and expeditious flow of civil air traffic. The purpose of Article 12 and Annex 11 is to ensure that civil aircraft operations on international air routes are performed under uniform conditions.

The International Standards and Recommended Practices in Annex 11 apply to airspace under the jurisdiction of a contracting state, derived from ICAO. Annex 11 provisions apply when air traffic services are provided and a contracting state accepts the responsibility of providing air traffic services over high seas or in airspace of undetermined sovereignty. A contracting state accepting this responsibility may apply the International Standards and Recommended Practices that are consistent with standards and practices utilized in its domestic jurisdiction.

In accordance with Article 3 of the Convention, state-owned aircraft are exempt from the Standards and Recommended Practices of Annex 11. The United States is a contracting state to the Convention. Article 3(d) of the Convention provides that participating state aircraft will be operated in international airspace with due regard for the safety of civil aircraft.

Because this amendment involves, in part, the designation of navigable airspace outside of the United States, the Administrator has consulted with the Secretary of State and the Secretary of Defense in accordance with the provisions of Executive Order 10854.

On May 20, 1982, the Secretary of the Interior conditionally approved the Alabama program. You can find background information on the Alabama program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the May 20, 1982, Federal Register (47 FR 22062). You can find later actions on the Alabama program at 30 CFR 901.15 and 901.16.

By letter dated April 11, 2000 (Administrative Record No. AL-0631), Alabama sent us an amendment to its program under SMCRA and the Federal regulations at 30 CFR 732.17(b). Alabama sent the amendment in response to our letters dated January 13, 1998, and October 15, 1998 (Administrative Record Nos. AL-0577 and AL-0587 respectively), that we sent to Alabama under 30 CFR 732.17(c). The amendment also includes changes made at Alabama's own initiative. Alabama proposes to amend the Alabama Surface Mining Commission (ASMC) rules.

We announced receipt of the amendment in the April 26, 2000, Federal Register (65 FR 24433). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. The public comment period closed on May 26, 2000. Because no one requested a public hearing or meeting, we did not hold one.

Following, under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are the Director's findings concerning the amendment to the Alabama program.

1. Alabama revised the definition of “government-finance construction” to read as follows:

The revised definition is substantively the same as the Federal definition of “government-financed construction” found at 30 CFR 707.5. Therefore, we find that Alabama's definition is no less effective than the Federal definition, and we are approving it.

2. In our letter dated October 15, 1998, we notified Alabama that its definitions of “material damage” and “occupied residential dwelling and structures related thereto” contained citation reference errors. Alabama corrected the definitions by removing a reference to 880-X-8I-.20 and adding a reference to 880-X-8I-.10. We find that the revised citation references are consistent with the citation references in the counterpart Federal definitions, and we are approving the revisions.

Alabama added language to Rule 880-X-2D-.04(1) to provide that with the exception of the requirements of Rule 880-X-2D-.06, if applicable, coal extraction which is incidental to government-financed construction is exempt from the Alabama Surface Mining Control and Reclamation Act and its implementing regulations.

As discussed below in finding C, Alabama's proposed exception to the exemption under Subchapter 880-X-2D would be applicable for coal removal incidental to government-financed construction where funding for the project is less than 50 percent and the construction is undertaken as an approved project under Title IV of SMCRA. Specifically, Rule 880-X-2D-.06 provides additional requirements for such coal removal when it is undertaken as part of a project under Alabama's approved Abandoned Mine Land Reclamation Program. Although the Federal regulations at 30 CFR Part 707 do not contain this exception language, the Federal regulations at 30 CFR Part 874 were revised to provide additional requirements for coal removal incident to AML projects receiving less than 50 percent government funding. Therefore, we find that the addition of the new exception language will not make Rule 880-X-2D-.04(1) less effective than the counterpart Federal regulation at 30 CFR 707.11(a).

Alabama proposes to add this new rule to provide additional requirements that apply to coal removal incidental to AML reclamation projects. The requirements of this rule apply to coal removal incidental to government-financed construction where funding for the project is less than 50 percent and the construction is undertaken as an approved reclamation project under Title IV of SMCRA. Paragraph (1) requires the AML contractor and any subcontractor involved in the removal of coal from, or processing of coal on, the project site to obtain or possess a valid license under Chapter 880-X-6 of Alabama's regulations. Paragraph (2) requires the AML contractor to identify the prospective purchasers or end users of all coal that he or she will extract under the project before the ASMC can grant concurrence under the Federal regulations at 30 CFR 874.17. Paragraph (3) requires the AML contractor to maintain records of the exact tonnage of coal removed, as well as the names and addresses of all purchasers or end users of the coal at the project site. The AML contractor must make these records available to the ASMC upon request. Paragraph (4) provides that this exemption applies only to coal located within the boundaries of the approved construction project. In addition, removal of the coal must be necessary to achieve the objectives of the AML reclamation project. Paragraph (5) provides that both the Alabama Department of Industrial Relations and the ASMC must approve the project in accordance with the provisions of the Federal regulations at 30 CFR 874.17 before the AML contractor can remove coal under Subchapter 880-X-2D. Finally, paragraph (6) provides that all coal removal under this exemption must be under the direct supervision of the AML contractor. The AML contractor is liable for any violations of these regulations.

This new rule establishes the conditions under which ASMC, as the Title V regulatory authority, will approve an exemption for the removal of coal incidental to performance of a government-financed construction project where government funding for the project is less than 50 percent and the construction in undertaken as an approved AML reclamation project under Alabama's approved Abandoned Mine Land Reclamation Program. There are no counterparts in the Federal regulations at 30 CFR Part 707 for the additional requirements proposed at Rule 880-X-2D-.06. However, the requirements are not inconsistent with the provisions in 30 CFR Part 707. Also, Alabama's proposed regulation at paragraph (5) ensures the ASMC and the Alabama AML agency's actions are consistent with the Federal regulations at 30 CFR 874.17, which provide AML agency procedures for coal removal incident to reclamation projects receiving less than 50 percent government funding. The Federal regulation at 30 CFR 874.17(a) requires the AML agency to make specific determinations in consultation with the Title V regulatory authority. The Federal regulation at 30 CFR 874.17(b) requires the AML agency to concur with the Title V regulatory authority in specific determinations before proceeding with an AML reclamation project that involves coal removal incident to government-financed construction with less than 50 percent government financing. These consultations and concurrences are intended to ensure the appropriateness of the project being undertaken as a Title IV AML project and not under the Title V regulatory program. Therefore, we are approving Alabama's new regulation at Rule 880-X-2D-.06.

In response to our letter dated January 13, 1998, Alabama added two additional sentences to Rule 880-X-8I-.08(2)(d). The revised regulation reads as follows:

Alabama's revised regulation at Rule 880-X-8I-.08(2)(d) is substantively the same as the counterpart Federal regulation at 30 CFR 784.13(b)(4), and we are approving it.

In our letter dated October 15, 1998, we notified Alabama that its regulation at 880-X-8I-.10(2)(h) contained a citation reference error. Alabama corrected its regulation by removing a reference to 880-X-10D-.12(10) and adding a reference to 880-X-10D-12(9). We find that the revised citation reference is consistent with the citation reference in the counterpart Federal regulation, and we are approving the revision.

On April 14, 2000, under section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Alabama program (Administrative Record No. AL-0633). By letter dated May 2, 2000 (Administrative Record No. AL-0638), the Mine Safety and Health Administration responded that it had no comments on the proposal.

Under 30 CFR 732.17(h)(11)(ii), we are required to obtain the written concurrence of the EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Alabama proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask the EPA for its concurrence.

Under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from the EPA (Administrative Record No. AL-0633). The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On April 14, 2000, we requested comments on Alabama's amendment (Administrative Record No. AL-0633). By letter dated May 17, 2000 (Administrative Record No. AL-0639), the Alabama Historical Commission (AHC) provided the following comments for our consideration:

1. The AHC commented that Alabama's regulation at 880-X-2D-.04(1) appears to state that coal extraction is exempt from these regulations and asked us to clarify Alabama's provision. The AHC thought that this statement appeared to be contrary to Section 106 of the National Historic Preservation Act of 1966.

Response: The exemption for extraction of coal which is incidental to Federal, State, or local government-financed highway or other construction is authorized by section 528(2) of SMCRA. Alabama's existing regulations at Subchapter 880-X-2D exempt the extraction of coal which is incidental to Federal, State, or local government-financed highway or other construction from the State Act and Alabama's regulations when that construction meets specified criteria. Alabama's current regulations limit the exemption to those construction projects that are funded 50 percent or more by a government agency. As discussed in finding A.1, the proposed revision extends the exemption to government funding at less than 50 percent if the construction is undertaken as an approved reclamation project under Title IV of SMCRA. As discussed in finding B, Alabama revised its applicability regulation at 880-X-2D-.04(1) to specify additional criteria that would apply to coal extraction under the new exemption. Alabama's proposed regulations at Subchapter 880-X-2D are no less effective than the Federal regulations at 30 CFR Part 707.

Compliance with Section 106 is not jeopardized by the proposed revision because it requires that, for coal extraction with less than 50 percent government funding to be exempt from the State Act and regulations, it must be included as an integral part of an approved abandoned mine land reclamation project that is administered by the State Abandoned Mine Land (AML) Reclamation Program. State AML Programs are required to comply with the requirements of Section 106 for all reclamation projects. The Alabama Historical Commission will be consulted prior to any coal extraction activities authorized under Alabama's proposed revision because such consultation is required by the Office of Surface Mining as part of the National Environmental Policy Act (NEPA) review of all AML reclamation projects.

2. AHC commented that historical and archaeological should be added to the definition of a “person having an interest which is or may be adversely affected * * * . ”

Response: Alabama is not proposing to revise this previously approved definition. Also, Alabama's definition is substantively identical to the Federal definition at 30 CFR 700.5. However, a copy of your comments will be forwarded to Alabama for consideration in a future rulemaking.

3. The AHC provided the following additional comments:

Response: Alabama is not proposing any revisions to its regulations concerning the consideration that must be given to historic properties, cultural resources, or cemeteries. Also, Alabama's currently approved regulations require coordination with requirements under other laws, including the National Historic Preservation Act of 1966. However, a copy of your comments will be forwarded to Alabama for consideration in a future rulemaking.

We asked for public comments on the amendment, but did not receive any.

Based on the above findings, we approve the amendment as sent to us by Alabama on April 11, 2000. We approve the rules that Alabama proposed with the provision that they be published in identical form to the rules sent to and reviewed by OSM and the public.

To implement this decision, we are amending the Federal regulations at 30 CFR Part 901, which codify decisions concerning the Alabama program. We are making this final rule effective immediately to expedite the State program amendment process and to encourage Alabama to bring its program into conformity with the Federal standards. SMCRA requires consistency of State and Federal standards.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations.

This rule does not have federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary under SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments since each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed State regulatory program provision does not constitute a major Federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

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

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

Because the Higher Education Amendments renamed the State Student Incentive Grant (SSIG) Program the Leveraging Educational Assistance Partnership (LEAP) Program, we are making conforming name changes to the Student Assistance General Provisions regulations, 34 CFR part 668, FFEL Program regulations, 34 CFR part 682, William D. Ford Federal Direct Loan Program regulations, 34 CFR part 685, and SSIG Program regulations, 34 CFR part 692.

We are also correcting cross-references and removing obsolete references. Therefore:

• We have replaced references to “institution of higher education” throughout 34 CFR part 692 with “institution” to reflect the type of institutions described in § 668.1(b) of the Student Assistance General Provisions regulations, and corrected other cross-references to various terms now defined in 34 CFR parts 600 and 668.

• We have removed references to section 1203 of the HEA throughout 34 CFR part 692 to reflect that this section was eliminated by the 1998 Amendments.

• We have removed OMB control numbers after §§ 692.20, 692.21 and 692.40.

It is the practice of the Secretary to offer interested parties the opportunity to comment on proposed regulations. However, these regulations merely reflect statutory changes, correct cross-references, and remove obsolete regulatory provisions. The changes do not establish or affect substantive policy. Therefore, the Secretary has concluded that these regulations are technical in nature and do not necessitate public comment. Therefore, the Secretary finds that such a solicitation would be unnecessary and contrary to the public interest under 5 U.S.C. 553(b)(B).

For the same reasons, the Secretary has determined, under section 492(b)(2) of the Higher Education Act of 1965, as amended, that these regulations should not be subject to negotiated rulemaking.

The Secretary certifies that these regulations would not have a significant economic impact on a substantial number of small entities. Small entities affected by these regulations are small institutions of higher education. Although States and State agencies are impacted by these regulations, they are not defined as “small entities” in the Regulatory Flexibility Act. These regulations contain technical amendments designed to clarify and correct current regulations. The changes will not have a significant economic impact on the institutions, State or State agencies affected.

These regulations have been examined under the Paperwork Reduction Act of 1995 and have been found to contain no information collection requirements.

The LEAP Program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. The objective of the Executive order is to foster an intergovernmental partnership and a strengthened federalism by relying on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

In accordance with the order, we intend this document to provide early notification of the Department's specific plans and actions for this program.

Based on our own review, we have determined that these final regulations do not require transmission of information that any other agency or authority of the United States gathers or makes available.

You may view this document in text or Adobe Portable Document Format (PDF) on the Internet at the following sites:

NARA published a notice of proposed rulemaking on May 8, 2000, at 65 FR 26542. The comment period ended June 7, 2000. NARA received no public comments.

This rule is effective upon publication for “good cause” as permitted by the Administrative Procedure Act (5 U.S.C. 553(d)(3)). NARA believes that delaying the effective date for 30 days is unnecessary as this rule represents a minor technical amendment. Moreover, as the public benefits immediately being provided with accurate contact information for all current NARA facilities, any delay in the effective date would be contrary to the public interest.

This rule is not a significant regulatory action for purposes of Executive Order 12866 of September 30, 1993, and has not been reviewed by the Office of Management and Budget. As required by the Regulatory Flexibility Act, it is hereby certified that this rule will not have a significant impact on a substantial number of small entities. This rule does not have federalism implications. It is not a major rule as defined in 5 U.S.C. chapter 8.

We are approving the Colorado, Montana, South Dakota, Utah, and Wyoming State Plans, as submitted on December 22, 1998 (with additional information submitted on October 4,1999); January 19, 1999; February 7, 2000; January 19, 1999 (with additional information submitted on October 25, 1999); and September 7, 1999 (with recodification of state regulations submitted on November 9, 1999), respectively. These plans were developed in accordance with section 111(d) of the CAA for the control of air emissions from HMIWIs. These plans do not apply to those HMIWIs located in Indian Country. When we developed our New Source Performance Standard (NSPS) for HMIWIs, we also developed Emissions Guidelines (EG) to control air emissions from older HMIWIs as we were required to do by section 129(a) of the Clean Air Act (42 U.S.C. 7429(a)). (See 62 FR 48348-48391, September 15, 1997). Colorado, Montana, South Dakota, Utah, and Wyoming, developed State Plans, as required by section 111(d) of the Clean Air Act (the Act) (42 U.S.C. 7411(d)), to adopt the EG into their body of regulations, and we are acting today to approve these State Plans as meeting all requirements of section 111(d) and 129 of the Act and EPA regulations governing the adoption and approval of State Plans for designated facilities (40 CFR part 60, subpart B).

In addition, as an administrative matter, the heading of 40 CFR part 62, subpart G is being corrected to include the state name, “Colorado.”

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in a separate document in this Federal Register publication, we are proposing to approve the revision should significant, material, and adverse comments be filed. This action is effective August 21, 2000, unless by July 24, 2000, adverse or critical comments are received. If we receive such comments, this action will be withdrawn before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will be addressed in a subsequent final rule based on this action serving as a proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. If no such comments are received, this action is effective August 21, 2000.

The State Plans establish control requirements which reduce the following emissions from HMIWIs: particulate matter, sulfur dioxide, hydrogen chloride, nitrogen oxides, carbon monoxide, lead, cadmium, mercury, dioxin, and dibenzofurans.

These pollutants can cause adverse effects to the public health and the environment. Dioxin, lead, and mercury bioaccumulate through the food web. Serious developmental and adult effects in humans, primarily damage to the nervous system, have been associated with exposures to mercury. Exposure to dioxin and furans can cause skin disorders, cancer, and reproductive effects such as endometriosis. Dioxin and furans can also affect the immune system. Acid gases affect the respiratory tract, as well as contribute to the acid rain that damages lakes and harms forests and buildings. Exposure to particulate matter has been linked with adverse health effects, including aggravation of existing respiratory and cardiovascular disease and increased risk of premature death. Nitrogen oxide emissions contribute to the formation of ground level ozone, which is associated with a number of adverse health and environmental effects.

Section 111(d) of the Act requires that pollutants, other than criteria pollutants, controlled under the NSPS must also be controlled at older sources in the same source category. Once an NSPS is promulgated for a non-criteria pollutant, we then publish an EG applicable to the control of the same pollutant from existing (designated) facilities. States with designated facilities must then develop a State Plan to adopt the EG into their body of regulations. States must also include in this State Plan other elements, such as inventories, legal authority, and public participation documentation, to demonstrate the ability to implement and enforce it.

Colorado adopted the Federal NSPS and EG by reference into its State regulations at Regulation No. 6, part A. The Colorado State Plan contains:

1. A demonstration of the State's legal authority to implement the section 111(d) State Plan. The State did not, however, submit evidence of authority to regulate existing HMIWI in Indian Country as defined in 18 U.S.C. 1151. Therefore, EPA is not approving this State Plan as it relates to those sources.

2. State rules adopted into Regulation No. 6 as the mechanism for implementing the emission guidelines.

3. An inventory of twelve known designated facilities, along with estimates of their toxic air emissions;

4. Emission limits that are as protective as the EG;

5. A compliance date of 1 year after EPA approval of the State Plan.

6. Testing, monitoring, reporting and recordkeeping requirements for the designated facilities;

7. Records from the public hearing; and,

8. Provisions for progress reports to EPA.

EPA compared the Colorado rules (Regulation No. 6, part A, subpart Ce) against our HMIWI EG. EPA finds the Colorado rules to be at least as protective as the EG. The Colorado State Plan was reviewed for approval with respect to the following criteria: 40 CFR 60.23 through 60.26, Subpart B—Adoption and Submittal of State Plans for Designated Facilities; and, 40 CFR 60.30e through 60.39e, Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators. The Colorado State Plan satisfies the requirements for an approvable section 111(d) plan under subparts B and Ce of 40 CFR part 60. For these reasons, we are approving the Colorado HMIWI State Plan.

The EG for existing HMIWIs affect any HMIWI built on or before June 20, 1996. If your facility meets this criterion and does not qualify for exemption under 40 CFR 60.32e(b)-(h) (Regulation No. 6, part A), you are subject to these regulations.

First, you will need to decide whether you will continue to operate your incinerator and comply with the requirements of the Colorado State Plan, or whether you will shut down your incinerator.

If you decide to continue operating your incinerator, you must meet the requirements listed in Regulation No. 6, part A, summarized as follows:

1. Determine the size of your incinerator by establishing its maximum design capacity.

2. You must meet the emission limits established for your incinerator's size category. See Table 1 of 40 CFR part 60, subpart Ce to determine the specific emission limits which apply to you. (40 CFR 60.33e; 62 FR 48382, September 15, 1997).

3. Determine if your incinerator qualifies for treatment as a small rural incinerator (40 CFR 60.33e(b), 60.36e, 60.37e(d), and 60.38e(b); 62 FR 48380, September 15, 1997).

4. You must meet a 10% opacity limit on your incinerator's discharge, averaged over a six-minute block (40 CFR 60.33e(c); 62 FR 48380, September 15, 1997).

5. You must have a qualified HMIWI operator available to supervise the operation of your incinerator. This operator must be trained and qualified through a State-approved program, or a training program that meets the requirements listed under 40 CFR 60.53c(c) (40 CFR 60.34e; 62 FR 48380). Your operator must be certified no later than one year after we approve Colorado's State Plan (40 CFR 60.39e(e); 62 FR 48382).

6. You must develop a waste management plan, and submit it to the Colorado Department of Public Health and Environment no later than one year after we approve this State Plan. Your waste management plan will describe the solid waste practices that your facility will undertake to reduce the amount of hospital, medical, and infectious waste that is disposed of in your incinerator. Your plan must be developed under guidance provided by the American Hospital Association publication, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, 1993. (40 CFR 60.35e; 62 FR 48380).

7. You must conduct an initial performance test to determine your incinerator's compliance with these emission limits. (40 CFR 60.37e and 60.8; 62 FR 48380).

8. You must install and maintain devices to monitor the parameters listed under Table 3 to subpart Ec (40 CFR 60.37e(c); 62 FR 48381).

9. You must document and maintain information concerning pollutant concentrations, opacity measurements, charge rates, and other operational data. This information must be maintained for a period of five years (40 CFR 60.38e; 62 FR 48381).

10. You must report to the Colorado Department of Public Health and Environment the results of your initial performance test, the values for your site-specific operating parameters, and your waste management plan. This information must be reported within 60 days following your initial performance test, and must be signed by the facilities manager (40 CFR 60.38e; 62 FR 48381).

11. You must submit a complete Title V operating permit application to the Colorado Department of Public Health and Environment no later than September 15, 2000.

12. In general, you must comply with all the requirements of this State Plan within one year after we approve it regardless of whether your facility has been identified in the plan inventory. The Colorado State Plan does not provide for petitions to extend the compliance deadlines (40 CFR 60.39e; 62 FR 48381).

If you decide to shut down your incinerator, you must do so within one year after we approve the State Plan in order to meet the requirements of Regulation No. 6, part A.

Montana adopted the Federal NSPS and EG by reference into its State regulations at Administrative Rules of Montana (ARM) 17.8.302, “Incorporation By Reference,” and ARM 17.8.340, “Standard of Performance For New Stationary Sources.” Montana State Plan contains:

1. A demonstration of the State's legal authority to implement the section 111(d) State Plan. The State did not, however, submit evidence of authority to regulate existing HMIWI in Indian Country as defined in 18 U.S.C. 1151. Therefore, EPA is not approving this State Plan as it relates to those sources.

2. State rules adopted into ARM 17.8.340 as the mechanism for implementing the emission guidelines.

3. An inventory of four known designated facilities, along with estimates of their toxic air emissions;

4. Emission limits that are as protective as the EG;

5. A compliance date of three years after EPA approval of the State Plan but not later than September 15, 2002.

6. Testing, monitoring, reporting and recordkeeping requirements for the designated facilities;

7. Records from the public hearing; and,

8. Provisions for progress reports to EPA.

EPA compared the Montana rules (ARM 17.8.302 and ARM 17.8.340) against our HMIWI EG. EPA finds the Montana rules to be at least as protective as the EG. The Montana State Plan was reviewed for approval with respect to the following criteria: 40 CFR 60.23 through 60.26, Subpart B—Adoption and Submittal of State Plans for Designated Facilities; and, 40 CFR 60.30e through 60.39e, Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators. The Montana State Plan satisfies the requirements for an approvable section 111(d) plan under subparts B and Ce of 40 CFR part 60. For these reasons, we are approving the Montana HMIWI State Plan.

The EG for existing HMIWIs affect any HMIWI built on or before June 20, 1996. If your facility meets this criterion and does not qualify for exemption under 40 CFR 60.32e (b)-(h) (ARM 17.8.340), you are subject to these regulations.

First, you will need to decide whether you will continue to operate your incinerator and comply with the requirements of the Montana State Plan, or whether you will shut down your incinerator.

If you decide to continue operating your incinerator, the Montana State Plan provides for measurable and enforceable incremental steps of progress for designated facilities planning to install the necessary air pollution control equipment allowing compliance on or before the date 3 years after EPA approval of the State Plan but not later than September 15, 2002. Further, Montana incorporated by reference the requirements contained in 40 CFR part 60, subpart Ce which contains additional compliance time requirements. You must meet the requirements listed in ARM 17.8.340, summarized as follows:

1. Determine the size of your incinerator by establishing its maximum design capacity.

2. Determine if your incinerator qualifies for treatment as a small rural incinerator (40 CFR 60.33e(b), 60.36e, 60.37e(d), and 60.38e(b); 62 FR 48380, September 15, 1997).

3. You must meet the emission limits established for your incinerator's size category. See Table 1 of 40 CFR part 60, subpart Ce to determine the specific emission limits which apply to you. (40 CFR 60.33e; 62 FR 48382, September 15, 1997).

4. You must meet a 10% opacity limit on your incinerator's discharge, averaged over a six-minute block (40 CFR 60.33e(c); 62 FR 48380, September 15, 1997).

5. You must have a qualified HMIWI operator available to supervise the operation of your incinerator. This operator must be trained and qualified through a State-approved program, or a training program that meets the requirements listed under 40 CFR 60.53c(c)(40 CFR 60.34e; 62 FR 48380). Your operator must be certified no later than one year after we approve the Montana State Plan (40 CFR 60.39e(e); 62 FR 48382).

6. You must develop a waste management plan, and submit it to the Montana Department of Environmental Quality no later than one year after we approve this State Plan. Your waste management plan will describe the solid waste practices that your facility will undertake to reduce the amount of hospital, medical, and infectious waste that is disposed of in your incinerator. Your plan must be developed under guidance provided by the American Hospital Association publication, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, 1993. (40 CFR 60.35e; 62 FR 48380).

7. You must submit a final Control Plan to the department for review and final approval within 15 months after the date of our approval of the State Plan. Your Control Plan will explain how your HMIWI will meet the State Plan requirements.

8. You must award contracts for any necessary control systems/process changes within 21 months after the date of our approval of the State Plan.

9. You must initiate on-site construction or installation of any necessary air pollution control devices, and initiate any necessary process changes, within 24 months after the date of our approval of the State Plan.

10. You must complete on-site construction or installation of any necessary air pollution control devices, and initiate any necessary process changes, within 24 months after the date of our approval of the State Plan.

11. You must conduct an initial performance test to determine your incinerator's compliance with these emission limits. (40 CFR 60.37e and 60.8; 62 FR 48380).

12. You must install and maintain devices to monitor the parameters listed under Table 3 to subpart Ec (40 CFR 60.37e(c); 62 FR 48381).

13. You must document and maintain information concerning pollutant concentrations, opacity measurements, charge rates, and other operational data. This information must be maintained for a period of five years (40 CFR 60.38e; 62 FR 48381).

14. You must report to the Montana Department of Environmental Quality the results of your initial performance test, the values for your site-specific operating parameters, and your waste management plan. This information must be reported within 60 days following your initial performance test, and must be signed by the facilities manager (40 CFR 60.38e; 62 FR 48381).

15. You must submit a complete Title V operating permit application to the Montana Department of Environmental Quality no later than September 15, 2000.

16. In general, you must comply with all the requirements of this State Plan within 36 months after we approve it or by September 15, 2002. (40 CFR 60.39e; 62 FR 48381).

If you decide to shut down your incinerator, you must submit a “final control plan” that notifies the department that you will be shutting down your incinerator within 15 months after the date of our approval of the State Plan.

South Dakota adopted the Federal NSPS and EG by reference into its State regulations at Administrative Rules of South Dakota (ARSD) 74:36:07, “New Source Performance Standards.” The South Dakota State Plan contains:

1. A demonstration of the State's legal authority to implement the section 111(d) State Plan. The State did not, however, submit evidence of authority to regulate existing HMIWI in Indian Country as defined in 18 U.S.C. 1151. Therefore, EPA is not approving this State Plan as it relates to those sources.

2. State rules adopted into ARSD 74:26:07:06.01 as the mechanism for implementing the emission guidelines.

3. An inventory of one known designated facility, along with estimates of its toxic air emissions;

4. Emission limits that are as protective as the EG;

5. A compliance date of 3 years after EPA approval of the State Plan but not later than September 15, 2002.

6. Testing, monitoring, reporting and recordkeeping requirements for the designated facilities;

7. Records from the public hearing; and,

8. Provisions for progress reports to EPA.

EPA compared the South Dakota rules (ARSD 74:36:07:06.01) against our HMIWI EG. EPA finds the South Dakota rules to be at least as protective as the EG. The South Dakota State Plan was reviewed for approval with respect to the following criteria: 40 CFR 60.23 through 60.26, Subpart B—Adoption and Submittal of State Plans for Designated Facilities; and, 40 CFR 60.30e through 60.39e, Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators. The South Dakota State Plan satisfies the requirements for an approvable section 111(d) plan under subparts B and Ce of 40 CFR part 60. For these reasons, we are approving the South Dakota HMIWI State Plan.

The EG for existing HMIWIs affect any HMIWI built on or before June 20, 1996. If your facility meets this criterion and does not qualify for exemption under 40 CFR 60.32e (b)-(h) (ARSD 74:36:07:06.01), you are subject to these regulations.

First, you will need to decide whether you will continue to operate your incinerator and comply with the requirements of the South Dakota State Plan, or whether you will shut down your incinerator.

If you decide to continue operating your incinerator, South Dakota's State Plan provides for measurable and enforceable incremental steps of progress for designated facilities planning to install the necessary air pollution control equipment allowing compliance on or before the date 3 years after EPA approval of the State Plan but not later than September 15, 2002. Further, South Dakota incorporated by reference the requirements contained in 40 CFR part 60, subpart Ce which contains additional compliance time requirements. You must meet the requirements listed in ARSD 74:36:07:06.01, summarized as follows:

1. Determine the size of your incinerator by establishing its maximum design capacity.

2. Determine if your incinerator qualifies for treatment as a small rural incinerator (40 CFR 60.33e(b), 60.36e, 60.37e(d), and 60.38e(b); 62 FR 48380, September 15, 1997).

3. You must meet the emission limits established for your incinerator's size category. See Table 1 of 40 CFR part 60, subpart Ce to determine the specific emission limits which apply to you. (40 CFR 60.33e; 62 FR 48382, September 15, 1997).

4. You must meet a 10% opacity limit on your incinerator's discharge, averaged over a six-minute block (40 CFR 60.33e(c); 62 FR 48380, September 15, 1997).

5. You must have a qualified HMIWI operator available to supervise the operation of your incinerator. This operator must be trained and qualified through a State-approved program, or a training program that meets the requirements listed under 40 CFR 60.53c(c)(40 CFR 60.34e; 62 FR 48380). Your operator must be certified no later than one year after we approve the South Dakota State Plan (40 CFR 60.39e(e); 62 FR 48382).

6. You must develop a waste management plan, and submit it to the South Dakota Department of Environment and Natural Resources no later than one year after we approve this State Plan. Your waste management plan will describe the solid waste practices that your facility will undertake to reduce the amount of hospital, medical, and infectious waste that is disposed of in your incinerator. Your plan must be developed under guidance provided by the American Hospital Association publication, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, 1993. (40 CFR 60.35e; 62 FR 48380).

7. You must submit a final Control Plan to the department for review and final approval within 6 months after the date of our approval of the State Plan. Your Control Plan will explain how your HMIWI will meet the State Plan requirements.

8. You must submit a part 70 operating permit application and design drawings of the air pollution control device to the department within one year after the date of our approval of the State Plan.

9. You must submit a copy of the purchase order or other documentation indicating an order has been placed for the major components of the air pollution control device within 15 months after the date of our approval of the State Plan.

10. You must begin initiation of site preparation for installation of the air pollution control device within 2 years after the date of our approval of the State Plan.

11. You must complete installation of the air pollution control device within 30 months after the date of our approval of this State Plan.

12. You must conduct an initial performance test to determine your incinerator's compliance with these emission limits (40 CFR 60.37e and 60.8; 62 FR 48380). This test must be completed within 33 months after the date of our approval of this State Plan.

13. You must install and maintain devices to monitor the parameters listed under Table 3 to subpart Ec (40 CFR 60.37e(c); 62 FR 48381).

14. You must document and maintain information concerning pollutant concentrations, opacity measurements, charge rates, and other operational data. This information must be maintained for a period of five years (40 CFR 60.38e; 62 FR 48381).

15. You must report to the South Dakota Department of Environment and Natural Resources the results of your initial performance test, the values for your site-specific operating parameters, and your waste management plan. This information must be reported within 60 days following your initial performance test, and must be signed by the facilities manager (40 CFR 60.38e; 62 FR 48381).

16. In general, you must comply with all the requirements of this State Plan within 36 months after we approve it or by September 15, 2002 (40 CFR 60.39e; 62 FR 48381).

If you decide to shut down your incinerator, you must notify the department within six months of the date of our approval of the State Plan. Your written notification must inform the department of when the unit will be shutdown. You shutdown date shall not be later than one year after the date of our approval of the State Plan.

Utah adopted the Federal NSPS and EG requirements into its State regulations at Utah Administrative Code (UAC) R307-220-3 and R307-222. The Utah State Plan contains:

1. A demonstration of the State's legal authority to implement the section 111(d) State Plan. The State did not, however, submit evidence of authority to regulate existing HMIWI in Indian Country as defined in 18 U.S.C. 1151. Therefore, EPA is not approving this State Plan as it relates to those sources.

2. State rules adopted into R307-222 as the mechanism for implementing the emission guidelines.

3. An inventory of fifteen known designated facilities, along with estimates of their toxic air emissions;

4. Emission limits that are as protective as the EG;

5. A compliance date of 1 year after EPA approval of the State Plan.

6. Provisions allowing designated facilities to petition the State for extensions, specifying incremental steps of progress towards compliance for facilities planning to install the necessary air pollution control equipment.

7. A Requirement that all designated facilities, whether or not they have been identified in the Plan, are in compliance no later than September 15, 2002.

8. Testing, monitoring, reporting and recordkeeping requirements for the designated facilities;

9. Records from the public hearing; and,

10. Provisions for progress reports to EPA.

EPA compared the Utah rules (UAC R307-220-3 and R307-222) against our HMIWI EG. EPA finds the Utah rules to be at least as protective as the EG. The Utah State Plan was reviewed for approval with respect to the following criteria: 40 CFR 60.23 through 60.26, Subpart B—Adoption and Submittal of State Plans for Designated Facilities; and, 40 CFR 60.30e through 60.39e, Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators. The Utah State Plan satisfies the requirements for an approvable section 111(d) plan under subparts B and Ce of 40 CFR part 60. For these reasons, we are approving the Utah HMIWI State Plan.

The EG for existing HMIWIs affect any HMIWI built on or before June 20, 1996. If your facility meets this criterion and does not qualify for exemption under 40 CFR 60.32e (b)-(h) (UAC R307-222-1.(2)), you are subject to these regulations.

First, you will need to decide whether you will continue to operate your incinerator and comply with the requirements of the Utah State Plan, or whether you will shut down your incinerator.

If you decide to continue operating your incinerator, Utah's State Plan requires that you comply with all requirements within one year after EPA approval of the State Plan, unless you petition the executive secretary of the Utah Department of Environmental Quality for a later compliance date. Utah also incorporated by reference the requirements contained in 40 CFR part 60, subpart Ce which contains additional compliance time requirements. You must meet the requirements listed in R307-220-3 and R307-222, summarized as follows:

1. Determine the size of your incinerator by establishing its maximum design capacity.

2. Determine if your incinerator qualifies for treatment as a small rural incinerator (40 CFR 60.33e(b), 60.36e, 60.37e(d), and 60.38e(b); 62 FR 48380, September 15, 1997).

3. You must meet the emission limits established for your incinerator's size category. See Table 1 of 40 CFR part 60, subpart Ce to determine the specific emission limits which apply to you. The emission limits apply at all times, except during startup, shutdown, or malfunctions, provided that no waste has been charged during these events. (40 CFR 60.33e; 62 FR 48382, September 15, 1997).

4. You must meet a 10% opacity limit on your incinerator's discharge, averaged over a six-minute block (40 CFR 60.33e(c); 62 FR 48380, September 15, 1997).

5. You must have a qualified HMIWI operator available to supervise the operation of your incinerator. This operator must be trained and qualified through a State-approved program, or a training program that meets the requirements listed under 40 CFR 60.53c(c) (40 CFR 60.34e; 62 FR 48380). Your operator must be certified no later than one year after we approve this Utah State Plan (40 CFR 60.39e(e); 62 FR 48382).

6. You must develop a waste management plan, and submit it to the Utah Department of Environmental Quality no later than one year after we approve this State Plan. Your waste management plan will describe the solid waste practices that your facility will undertake to reduce the amount of hospital, medical, and infectious waste that is disposed of in your incinerator. Your plan must be developed under guidance provided by the American Hospital Association publication, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, 1993. (40 CFR 60.35e; 62 FR 48380).

7. You must conduct an initial performance test to determine your incinerator's compliance with these emission limits. (40 CFR 60.37e and 60.8; 62 FR 48380).

8. You must install and maintain devices to monitor the parameters listed under Table 3 to subpart Ec (40 CFR 60.37e(c); 62 FR 48381).

9. You must document and maintain information concerning pollutant concentrations, opacity measurements, charge rates, and other operational data. This information must be maintained for a period of five years (40 CFR 60.38e; 62 FR 48381).

10. You must report to the Utah Department of Environmental Quality the results of your initial performance test, the values for your site-specific operating parameters, and your waste management plan. This information must be reported within 60 days following your initial performance test, and must be signed by the facilities manager (40 CFR 60.38e; 62 FR 48381).

11. You must submit a complete Title V operating permit application to the Utah Department of Environmental Quality no later than September 15, 2000.

12. In general, you must comply with all the requirements of this State Plan within one year after we approve it; however, there are provisions to extend your compliance date (40 CFR 60.39e; 62 FR 48381). The criteria for requesting an extension of your compliance date, and the milestones that you would be required to meet, are explained in R307-222-3 and the Utah State Plan. You may petition the Executive Secretary of the Utah Department of Environmental Quality to extend your compliance date to a date as late as three years after we approve this Utah State Plan, but no later than September 15, 2002.

If you decide to shut down your incinerator, you must do so within one year of our approval of this State Plan, unless you petition the Executive Secretary for a later date in accordance with the provisions of the State Plan and R307-222-3.

Wyoming adopted the Federal NSPS and EG requirements into the Wyoming Air Quality Standards and Regulations (WAQSR), Chapter 4, section 5. The Wyoming State Plan contains:

1. A demonstration of the State's legal authority to implement the section 111(d) State Plan. The State did not, however, submit evidence of authority to regulate existing HMIWI in Indian Country as defined in 18 U.S.C. 1151. Therefore, EPA is not approving this State Plan as it relates to those sources.

2. State rules adopted into WAQSR Chapter 4, section 5, as the mechanism for implementing the emission guidelines.

3. An inventory of thirty-four known designated facilities, along with estimates of their toxic air emissions;

4. Emission limits that are as protective as the EG;

5. A compliance date of three years after EPA approval of the State Plan but not later than September 15, 2002.

6. Testing, monitoring, reporting and recordkeeping requirements for the designated facilities;

7. Records from the public hearing; and,

8. Provisions for progress reports to EPA.

EPA compared the Wyoming rules (WAQSR Chapter 4, section 5) against our HMIWI EG. EPA finds the Wyoming rules to be at least as protective as the EG. The Wyoming State Plan was reviewed for approval with respect to the following criteria: 40 CFR 60.23 through 60.26, Subpart B—Adoption and Submittal of State Plans for Designated Facilities; and, 40 CFR 60.30e through 60.39e, Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators. The Wyoming State Plan satisfies the requirements for an approvable section 111(d) plan under subparts B and Ce of 40 CFR part 60. For these reasons, we are approving the Wyoming HMIWI State Plan.

The EG for existing HMIWIs affect any HMIWI built on or before June 20, 1996. If your facility meets this criterion and does not qualify for exemption under 40 CFR 60.32e (b)-(h) (WAQSR Ch. 4, sec. 5(b)(ii)-(ix)), you are subject to these regulations.

First, you will need to decide whether you will continue to operate your incinerator and comply with the requirements of the Wyoming State Plan, or whether you will shut down your incinerator.

If you decide to continue operating your incinerator, Wyoming's State Plan requires that you comply with all requirements within one year after EPA approval of the State Plan, unless you petition the Administrator of the Wyoming Air Quality Division for a later compliance date. Wyoming also incorporated the requirements contained in 40 CFR part 60, subpart Ce which contains additional compliance time requirements. You must meet the requirements listed in WAQS&R Ch. 4, sec. 5, summarized as follows:

1. Determine the size of your incinerator by establishing its maximum design capacity.

2. Determine if your incinerator qualifies for treatment as a small rural incinerator (40 CFR 60.33e(b), 60.36e, 60.37e(d), and 60.38e(b); 62 FR 48380, September 15, 1997).

3. You must meet the emission limits established for your incinerator's size category. See Table 1 of 40 CFR part 60, subpart Ce to determine the specific emission limits which apply to you. (40 CFR 60.33e; 62 FR 48382, September 15, 1997).

4. You must meet a 10% opacity limit on your incinerator's discharge, averaged over a six-minute block (40 CFR 60.33e(c); 62 FR 48380, September 15, 1997).

5. You must have a qualified HMIWI operator available to supervise the operation of your incinerator. This operator must be trained and qualified through a State-approved program, or a training program that meets the requirements listed under 40 CFR 60.53c(c) (40 CFR 60.34e; 62 FR 48380). Your operator must be certified no later than one year after we approve the Wyoming State Plan (40 CFR 60.39e(e); 62 FR 48382).

6. You must develop a waste management plan, and submit it to the Wyoming Department of Environmental Quality no later than one year after we approve this State Plan. Your waste management plan will describe the solid waste practices that your facility will undertake to reduce the amount of hospital, medical, and infectious waste that is disposed of in your incinerator. Your plan must be developed under guidance provided by the American Hospital Association publication, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, 1993 (40 CFR 60.35e; 62 FR 48380).

7. You must conduct an initial performance test to determine your incinerator's compliance with these emission limits (40 CFR 60.37e and 60.8; 62 FR 48380).

8. You must install and maintain devices to monitor the parameters listed under Table 3 to subpart Ec (40 CFR 60.37e(c); 62 FR 48381).

9. You must document and maintain information concerning pollutant concentrations, opacity measurements, charge rates, and other operational data. This information must be maintained for a period of five years (40 CFR 60.38e; 62 FR 48381).

10. You must report to the Wyoming Department of Environmental Quality the results of your initial performance test, the values for your site-specific operating parameters, and your waste management plan. This information must be reported within 60 days following your initial performance test, and must be signed by the facilities manager (40 CFR 60.38e; 62 FR 48381).

11. You must submit a complete Title V operating permit application to the Wyoming Department of Environmental Quality no later than September 15, 2000.

12. In general, you must comply with all the requirements of this State Plan within one year after we approve it; however, there are provisions to extend your compliance date (40 CFR 60.39e; 62 FR 48381). The criteria for requesting an extension of your compliance date, and the milestones that you would be required to meet, are explained in WAQSR Ch. 4, sec. 5(i) and the Wyoming State Plan. You may petition the Administrator of the Wyoming Air Quality Division to extend your compliance date to a date as late as three years after we approve this Wyoming State Plan, but no later than September 15, 2002.

If you decide to shut down your incinerator, you must do so within one year of our approval of this State Plan, or by September 15, 2000, whichever occurs first (WAQSR Ch. 4, sec. 5(i)(i)).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget.

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

This rule is not subject to Executive Order 13045 because it is not an economically significant action under Executive Order 12866.

Under Executive Order 13084 (63 FR 27655, May 10, 1998), EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule implements requirements specifically set forth by the Congress in sections 111 and 129 of the Clean Air Act, as amended in 1990, without the exercise of any discretion by EPA. This action does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

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

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

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

Pursuant to section 605(b) of the RFA, I certify that this rule will not have a significant economic impact on a substantial number of small entities. This Federal action approves pre-existing requirements under State law and imposes no new requirements on any entity affected by this rule, including small entities. Therefore, these amendments will not have a significant impact on a substantial number of small entities.

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register .

In reviewing 111(d)/129 plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a 111(d)/129 plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a 111(d)/129 plan submission, to use VCS in place of a 111(d)/129 plan submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 21, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

This document is divided into Sections I through V and answers the questions posed below.

A. EPA is approving the Arizona 111(d)/129 plan (the “plan”) for the control of air pollutant emissions from hospital/medical/infectious waste incinerators (HMIWIs). The plan was submitted to EPA by the Arizona Department of Environmental Quality (ADEQ) on November 16, 1999. The plan contains requirements applicable to HMIWIs located in the jurisdictions of ADEQ and the Maricopa County Environmental Services Department (MCESD). EPA is publishing this approval action without prior proposal because we view this as a noncontroversial action and anticipate no adverse comments.

A. Section 111(d) of the Clean Air Act (CAA) requires that “designated” pollutants, controlled under standards of performance for new stationary sources by section 111(b) of the CAA, must also be controlled at existing sources in the same source category to a level stipulated in an emission guidelines (EG) document. Section 129 of the CAA specifically addresses solid waste incineration and emissions controls based on what is commonly referred to as maximum achievable control technology (MACT). Section 129 requires EPA to promulgate a MACT based emission guideline (EG) document and then requires states to develop 111(d)/129 plans that implement and enforce the EG requirements. The HMIWI EG at 40 CFR part 60, subpart Ce, establish the MACT requirements under the authority of both sections 111(d) and 129 of the CAA. These requirements must be incorporated into a State 111(d)/129 plan that is “at least as protective” as the EG and is Federally enforceable upon approval by EPA.

The procedures for adoption and submittal of State 111(d)/129 plans are codified in 40 CFR part 60, subpart B. Additional information on the submittal of State plans is provided in the EPA document, “Hospital/Medical/Infectious Waste Incinerator Emission Guidelines: Summary of the Requirements for Section 111(d)/129 State Plan, EPA-456/R-97-007, November, 1997.”

A. The September 15, 1997 promulgated EG, Subpart Ce, are applicable to all existing HMIWIs ( i.e., the designated facilities). HMIWIs emit metals (cadmium, lead, mercury, particulate matter, and opacity), acid gases (hydrogen chloride and sulphur dioxide), organics (dioxins/furans), carbon monoxide, and nitrogen oxides. This action establishes emission limitations for each of these pollutants.

A. HMIWI emissions can have adverse effects on both public health and the environment. Dioxin, lead, and mercury can bioaccumulate in the environment. Exposure to dioxins/furans has been linked to reproductive and developmental effects, changes in hormone level, and chloracne. Respiratory and other effects are associated with exposure to particulate matter, sulfur dioxide, cadmium, hydrogen chloride, and mercury. Health effects associated with exposure to cadmium and lead include probable carcinogenic effects. Acid gases contribute to the acid rain that lowers the pH of surface waters and watersheds, harms forests, and damages buildings.

A. The plan must meet the requirements of both 40 CFR part 60, subparts B and Ce. Subpart B specifies detailed procedures for the adoption and submittal of State plans for designated pollutants and facilities. The EG, subpart Ce, and the related new source performance standards (NSPS), subpart Ec, contain the requirements for the control of designated pollutants, as listed above, in accordance with sections 111(d) and 129 of the CAA. In general, the applicable provisions of subpart Ec relate to compliance and performance testing, monitoring, reporting, and recordkeeping. More specifically, the Arizona plan must meet the requirements of (1) 40 CFR part 60, subpart Ce, sections 60.30e through 60.39c, and the related subpart Ec provisions; and (2) 40 CFR part 60, subpart B, sections 60.23 through 26.

A. Consistent with the requirements of subparts B, Ce and Ec, the Arizona plan contains the following elements:

1. A demonstration of the ADEQ's and MCESD's legal authority to implement the plan, in their respective jurisdictions, under Arizona law;

2. Identification of the plan's enforceable mechanisms, Arizona Administrative Code (AAC) R18-2-732 (Standards of Performance for Existing Hospital/Medical/Infectious Waste Incinerators), and Maricopa County Rule 317 (Hospital/Medical/Infectious Waste Incinerators);

3. Source and emission inventories, as required;

4. Emission limitation requirements that are no less stringent than those in Subpart Ce;

5. A source compliance schedule, including increments of progress, as required;

6. Source testing, monitoring, recordkeeping, and reporting requirements;

7. HMIWI operator training and qualification requirements;

8. Requirements for development of a Waste Management Plan;

9. Records of the public hearing on the State plan;

10. Provision for State submittal to EPA of annual reports on progress in plan enforcement; and

11. A Title V permit application due date.

The State regulation, AAC R18-2-732, was adopted by the Governor's Regulatory Review Council on August 3, 1999 and became effective on August 10, 1999. The Maricopa County regulation, Rule 317, was adopted by MCESD on April 7, 1999 and became effective on April 7, 1999. Both regulations incorporate by reference (IBR) applicable subpart Ec requirements.

A. Yes. The ADEQ has submitted a plan that conforms to all EPA Subpart B and Ce requirements. Each of the above listed plan elements is approvable. Details regarding the approvability of the plan elements are included in the technical support document (TSD) associated with this action. A copy of the TSD is available, upon request, from the EPA Regional Office listed in the ADDRESSES section of this document.

A. The Arizona plan only applies to HMIWIs under the jurisdictions of ADEQ and MCSED. 1 If construction commenced on your HMIWI on or before June 20, 1996, your HMIWI is classified as an existing or designated facility that may be subject to the plan. The plan contains no lower applicability threshold based on incinerator capacity. However, there are designated facility exemptions. Those exemptions include incinerators that burn only pathological, low level radioactive, and/or chemotherapeutic waste; co-fired combustors; incinerators permitted under section 3005 of the Solid Waste Disposal Act; municipal waste combustors (MWC) subject to EPA's municipal waste combustor rule; pyrolysis units; and cement kilns. The provisions regarding applicability and exemptions are found in section A of AAC R18-2-732 and in section 102 of Maricopa Rule 317.

A. In general, the State and Maricopa County HMIWI regulations establish the following requirements:

• Emission limitations for particulate matter (PM), opacity, carbon monoxide (CO), dioxins/furans (CDD/CDF), hydrogen chloride (HCl), sulfur dioxide (SO 2 ), nitrogen oxides (NO X ), lead (Pb), cadmium (Cd), and mercury (Hg)

• Compliance and performance testing

• Operating parameter monitoring

• Operator training and qualification

• Development of a waste management plan

• Source testing, recordkeeping and reporting

• A Title V permit

A full and comprehensive statement of the above requirements is incorporated in the AAC R18-2-732 and Maricopa Rule 317.

A. You must install an emissions control system capable of meeting the maximum available control technology (MACT) emission limitations for the pollutants identified above. The emissions limitations are stipulated in section E of AAC R18-2-732 and in sections 302 and 303 of Maricopa Rule 317. All designated facilities must be in compliance with the emission limitations on or before the effective date of the relevant regulation.

A. Yes, there are operational requirements. In summary, the operational requirements relate to: (1) The HMIWI and air pollution control devices (APCD) operating within certain established parameter limits, determined during the initial performance test; (2) the use of a trained and qualified HMIWI operator; and (3) the completion of an annual update of operation and maintenance information, and its review by the HMIWI operators.

Failure to operate the HMIWI or APCD within the established operating parameter limits constitutes an emissions violation for the controlled air pollutants. However, as a HMIWI owner/operator, you are provided an opportunity to establish revised operating limits, and demonstrate that your facility is meeting the required emission limitations, providing a repeat performance test is conducted in a timely manner.

A fully trained and qualified operator must be available at your facility during the operation of the HMIWI, or the operator must be readily available to the facility within one hour. In order to be classified as a qualified operator, you must complete an appropriate HMIWI operator training course that meets the Subpart Ec criteria referenced in AAC R18-2-732 at section F and in Maricopa Rule 317 at sections 301 and 306. The Arizona plan requires compliance with this training requirement within one year of EPA approval of the State Plan.

Also, as a HMIWI owner/operator, you are required to develop and update annually site-specific information regarding your facilities' operations. Each of your HMIWI operators is required on an annual basis to review the updated operational information. The ADEQ and MCESD regulations IBR the applicable operational requirements of the EG and the related NSPS. See subpart Ec, sections 60.53c, 60.56c, and 60.58c, respectively for details regarding these operational requirements.

A. Testing, monitoring, recordkeeping, and reporting requirements are summarized below:

You are required to conduct an initial stack test to determine compliance with the emission limitations for PM, opacity, CO, CDD/CDF, HCl, Pb, Cd, and Hg. As noted above, operating parameter limits are monitored and established during the initial performance test. Monitored HMIWI operating parameters include, for example, waste charge rate, secondary chamber and bypass stack temperatures. APCD operating parameters include, for example, CDD/CDF and Hg sorbent ( e.g., carbon) flow rate, hydrogen chloride sorbent ( e.g., lime) flow rate, PM control device inlet temperature, pressure drop across the control system, and liquid flow rate, including pH. After the initial stack test, compliance testing is then required annually to determine compliance with the emission limitations for PM, CO, and HCl.

Recordkeeping and reporting are required in order to document: (1) The results of the initial and annual performance tests, (2) monitoring of site-specific operating parameters, (3) compliance with the operator training and qualification requirements, and (4) development of the waste management plan. Records must be maintained for at least five years.

The ADEQ and MCESD regulations IBR the applicable testing, monitoring, recordkeeping, and reporting requirements of the EG and related NSPS. See subpart Ec, sections 60.56c, 60.57c, and 60.58c, respectively for details regarding these requirements.

A. Yes, affected facilities are required to operate under a Title V permit no later than September 15, 2000. This is required under section D of AAC R18-2-732 and section 401 of Maricopa Rule 317.

Based upon the rationale discussed above and in further detail in the TSD associated with this action, EPA is approving the Arizona 111(d)/129 plan for the control of HMIWI emissions from designated facilities. 2 As provided by 40 CFR 60.28(c), any revisions to the Arizona plan or associated regulations will not be considered part of the applicable plan until submitted by the ADEQ in accordance with 40 CFR 60.28(a) or (b), as applicable, and until approved by EPA in accordance with 40 CFR part 60, subpart B.

EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the 111(d) plan should relevant adverse or critical comments be filed. This rule will be effective August 21, 2000 without further notice unless the Agency receives relevant adverse comments by July 24, 2000. If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this rule. Parties interested in commenting on this rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on August 21, 2000 and no further action will be taken on the proposed rule.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing 111(d)/129 plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a 111(d)/129 plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a 111(d)/129 plan submission, to use VCS in place of a 111(d)/129 plan submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 21, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

This section provides additional information by addressing the following questions:

The CAA Amendments of 1990 required all state and local permitting authorities to develop operating permit programs that met certain Federal criteria. In implementing the operating permit programs, the permitting authorities require certain sources of air pollution to obtain permits that contain all applicable requirements under the CAA. The focus of the operating permit program is to improve enforcement by issuing each source a permit that consolidates all of the applicable CAA requirements into a Federally enforceable document. By consolidating all of the applicable requirements for a facility, the source, the public, and the permitting authorities can more easily determine what CAA requirements apply and how compliance with those requirements is determined.

Sources required to obtain an operating permit under this program include: “major” sources of air pollution and certain other sources specified in the CAA or in EPA's implementing regulations. For example, all sources regulated under the acid rain program, regardless of size, must obtain operating permits. Examples of major sources include those that have the potential to emit 100 tons per year or more of volatile organic compounds, carbon monoxide, lead, sulfur dioxide, nitrogen oxides, or particulate matter (PM 10 10); those that emit 10 tons per year of any single hazardous air pollutant (specifically listed under the CAA); or those that emit 25 tons per year or more of a combination of hazardous air pollutants (HAPs). In areas that are not meeting the National Ambient Air Quality Standards for ozone, carbon monoxide, or particulate matter, major sources are defined by the gravity of the nonattainment classification. For example, in ozone nonattainment areas classified as “serious,” major sources include those with the potential of emitting 50 tons per year or more of volatile organic compounds or nitrogen oxides.

Where an operating permit program substantially, but not fully, met the criteria outlined in the implementing regulations codified at 40 Code of Federal Regulations (CFR) part 70, EPA granted interim approval contingent on the state revising its program to correct the deficiencies. Because Forsyth County's operating permit program substantially, but not fully, met the requirements of part 70, EPA granted interim approval to the program in a rulemaking published on November 15, 1995 (60 FR 57357). The interim approval notice stipulated eight conditions that had to be met in order for the County's program to receive full approval. Forsyth County submitted nine revisions to its interimly approved operating permit program; these revisions were dated September 25, 1995, January 16, 1997, August 1, 1997, April 22, 1998, October 2, 1998, February 18, 1999, September 29, 1999, October 26, 1999, and February 24, 2000. This document describes the changes that have been made in Forsyth County's operating permit program.

Full approval of Forsyth County's operating permit program was made contingent upon the following rule changes, as stipulated in EPA's November 15, 1995 rulemaking:

(1) Revise Rule 3Q.0507 to require permit applications include all fugitive emissions, in accordance with 40 CFR 70.3(d). The County revised Rule 3Q.0507(b) to cite 40 CFR 70.3(d) and the local-effective rule change was submitted to EPA on August 1, 1997.

(2) Revise Rule 3Q.0502(c) to ensure that research and development (R&D) facilities which are collocated with manufacturing facilities and which are under common control and belonging to a single major industrial grouping will be considered as the same facility for determining title V applicability. The County deleted Rule 3Q.0502(c) and the local-effective rule change was submitted to EPA on October 26, 1999.

(3) Revise Rule 3Q.0102(b)(2)(B) to adjust the insignificant emission threshold levels downward from potential emissions of 40 tons per year (tpy) to 5 tpy for criteria pollutants and 1000 pounds per year for HAPs, and to provide that the activities listed in Rule 3Q.0102(b)(2)(F) are subject to these caps. In addition, EPA notified the County on July 15, 1996 of another deficiency in its insignificant activities provisions that came to light as a result of the court decision in Western States Petroleum Association (WSPA) v. EPA, 87 F.3d 280 (D.C. Cir. 1996): Rule 3Q.0102(a) had inadvertently been approved without identifying the exemption of insignificant activities from permit requirements as a program deficiency. In the Federal Register document granting final interim approval to the Alaska operating permit program (61 FR 64466, December 5, 1996), EPA acknowledged that its approval of the insignificant activities provisions in the North Carolina programs may have been inconsistent with the WSPA decision. Further review revealed this to be true.

Forsyth County addressed the deficiencies in its insignificant activities provisions by removing Rule 3Q.0102 from its operating permit program and revising Rule 3Q.0503 to define two categories of insignificant activities: “insignificant activities because of category” and “insignificant activities because of size or production rate.” The first category includes:

(a) Mobile sources,

(b) Air conditioning units used for human comfort that are not subject to applicable requirements under Title VI of the Federal Clean Air Act and do not exhaust air pollutants into the ambient air from any manufacturing or other industrial process,

(c) Ventilating and heating units used for human comfort that do not exhaust air pollutants into the ambient air from any manufacturing or other industrial process,

(d) Noncommercial food preparation,

(e) Consumer use of office equipment,

(f) Janitorial services and consumer use of janitorial products,

(g) Internal combustion engines used for landscaping purposes, and

(h) New residential wood heaters subject to 40 CFR 60, Subpart AAA.

The second category, “insignificant activities because of size or production rate,” is defined as “any activity whose emissions would not violate any applicable emissions standard and whose potential emission of particulate, sulfur dioxide, nitrogen oxides, volatile organic compounds, and carbon monoxide before air pollution control devices, i.e. , potential uncontrolled emissions, are each no more than five tons per year and whose potential emissions of hazardous air pollutants before air pollution control devices are each below 1000 pounds per year.” The County also revised Rule 3Q.0508(f)(3) to remove the exemption from monitoring, recordkeeping, and reporting requirements for insignificant activities, and revised Rule 3Q.0508(aa) to require the inclusion of insignificant activities in permits. The local-effective rule changes were submitted to EPA on October 26, 1999.

(4) Revise Rule 3Q.0514(a) to clarify that: (a) Administrative permit amendments may be used to change test dates or construction dates only as long as no applicable requirements are violated in the process, and (b) an administrative permit amendment may be used to move terms and conditions from the state-enforceable portion of the permit to the state-and Federal-enforceable portion of the permit provided that the term being moved is a requirement which has become Federally enforceable through sections 110, 111, 112, or other parts of the Act. The County added language to Rule 3Q.0514(a)(4) stipulating that changes in test dates or construction dates qualify as administrative permit amendments “provided that no applicable requirements are violated by the change in test dates or construction dates.” The County also added language to Rule 3Q.0514(a)(5) stipulating that administrative permit amendments may be used to move terms and conditions from the County-enforceable portion of the permit to the County-and-Federal enforceable portion of the permit “provided that terms and conditions being moved have become federally enforceable through section 110, 111, or 112 or other parts of the federal Clean Air Act.” The local-effective rule changes were submitted to EPA on August 1, 1997.

(5) Revise Rule 3Q.0515(f) to stipulate that a permit shield may not be granted for a minor permit modification. The County revised Rule 3Q.0515 to disallow permit shields for minor permit modifications and submitted the local-effective rule change to EPA on August 1, 1997.

(6) Revise Rule 3Q.0515(d) to require minor permit modifications to be processed within 90 days after receiving the application or 15 days after the end of EPA's 45-day review period, whichever is later. The County revised Rule 3Q.0515(d) accordingly and submitted the local-effective rule change to EPA on August 1, 1997.

(7) Revise Rule 3Q.0517(b) to provide that: (a) a part 70 permit shall be reopened and reissued within 18 months after a newly applicable requirement is promulgated, and (b) no reopening is required if the effective date of the newly applicable requirement is after the expiration of the permit, unless the term of the permit was extended based on the fact that it had not been renewed prior to its expiration. The County revised Rule 3Q.0517(b) to require the completion of permit reopenings within 18 months after newly applicable requirements are promulgated. This rule was also revised to state that “[n]o reopening is required if the effective date of the requirement is after the expiration of the permit term unless the term of the permit was extended pursuant to Rule .0513(c). . .” The local-effective revised rule was submitted to EPA on August 1, 1997.

(8) Revise Rule 3Q.0518(f) to remove the phrase “subject to adjudication” from the requirement to take action on a complete permit application. The County deleted Rule 3Q.0518(f) and submitted the local-effective rule revision to EPA on September 25, 1995.

Forsyth County made several additional program changes after EPA granted interim approval on November 15, 1995. The definition of “Major facility” as “a major source as defined under 40 CFR 70.2” was added to Rule 3Q.0103 in the general provisions of the County's air quality permitting regulations. The County submitted the local-effective rule revision to EPA on January 16, 1997. The County also changed the method for determining its annual title V fee. Forsyth County's operating permit program was initially approved based on use of the “presumptive minimum” fee described in 40 CFR 70.9(b)(2)(i). However, the County revised Rule 3Q.0204 in October 1996 to use a mechanism based on 40 CFR 70.9(b)(1), which involves establishing a fee schedule that results in the collection and retention of revenues sufficient to cover the actual costs of the operating permit program. The County now establishes its annual fee schedule based on the actual cost of administering the title V program during the previous year. The County submitted the revised fee rule to EPA on January 16, 1997, and submitted documentation of fee increases on April 22, 1998, February 18, 1999 and February 24, 2000. The County also submitted a fee program update on September 29, 1999 demonstrating that its title V program is adequately funded by operating permit fees.

The other substantive changes in Forsyth County's title V program involve the following:

(1) Revising the definition of “Affected States” in Rule 3Q.0503 to mean all States or local air pollution control agencies whose areas of jurisdiction are contiguous to Forsyth County, rather than contiguous to the entire state. The local-effective rule revision was submitted to EPA on October 2, 1998.

(2) Deleting the part 70 permit application processing schedule in Rule 3Q.0507(f) and replacing it with a new application processing schedule in Rule 3Q.0525. The new schedule established time frames for the County to complete various aspects of permit issuance, including acknowledging receipt of the application, the completeness check, the technical review, mailing the public notice, and holding a public hearing if one is requested. Rule 3Q.0525 was initially submitted to EPA on September 25, 1995 and then amended in September 1998 to ensure that final action on permit applications would be taken within 18 months of being deemed complete, as stipulated in 40 CFR 70.7(a)(2). The amended rule was submitted to EPA on October 2, 1998.

The Forsyth County Environmental Affairs Department has fulfilled the conditions of the interim approval granted on November 15, 1995, and EPA is taking final action by this notice to fully approve the County's operating permit program. EPA is also taking action to approve other program changes made by the County since the interim approval was granted.

EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to grant final full approval should adverse comments be filed. This action will be effective August 21, 2000 unless the Agency receives adverse comments by July 24, 2000.

If EPA receives such comments, then EPA will withdraw the final rule and inform the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on August 21, 2000 and no further action will be taken on the proposed rule.

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

As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

This rule is not subject to Executive Order 13045 because it is not an economically significant regulatory action as defined in Executive Order 12866, and it does not involve decisions intended to mitigate environmental health or safety risks.

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

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

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

This final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

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

This rule will not have a significant impact on a substantial number of small entities because part 70 approvals under section 502 of the Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because this approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of a flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 21, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

In reviewing operating permit programs, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use VCS, EPA has no authority to disapprove an operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of an operating permit program that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of NTTAA do not apply.

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

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

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

2. In person. The Agency has established an official record for this action under docket control number OPP-301003. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

This final rule revokes and modifies the FFDCA tolerances for residues of the insecticide azinphos-methyl in or on certain specified commodities, in accordance with a Memorandum of Agreement (MOA) of August 2, 1999, between registrants and EPA. In the Federal Register of December 22, 1999 (64 FR 71708) (FRL-6399-6), EPA issued a proposed rule to revoke the tolerances listed in this final rule. The December 22, 1999 proposal invited public comment for consideration. No comments were received by the Agency.

EPA is revoking and modifying certain tolerances for residues of the insecticide azinphos-methyl in 40 CFR 180.154. In particular, EPA is revoking the tolerance on sugarcane, with a revocation/expiration date of June 30, 2000, since by agreement this use has been deleted from active labels, because of surface water vulnerability and to prevent unreasonable risks to wildlife and contamination of water. EPA is setting the revocation/expiration date of June 30, 2000, in order to allow time for existing stocks in the hands of users to be used.

EPA is lowering tolerances found in 40 CFR 180.154(a) for residues of the insecticide azinphos-methyl in or on apples, crabapples, pears, and quinces, each from 2.0 ppm to 1.5 ppm, in or on cranberries from 2.0 ppm to 0.5 ppm, and in or on grapes from 5.0 ppm to 4.0 ppm. These modifications will be effective 90 days after the publication of this final rule in the Federal Register .

Also, the Agency is revoking tolerances for residues of azinphos-methyl in or on commodities for which there are no registered uses; including: apricots; artichokes; barley, grain; barley, straw; beans (dry); gooseberries; grass, pasture (green); grass, pasture, hay; kiwi fruit; oats, grain; oats, straw; peas, black-eyed; rye, grain; rye, straw; soybeans; wheat, grain; and wheat, straw in 40 CFR 180.154(a), and pomegranates in 40 CFR 180.154(b). These revocations concern uses that have not been on active labels since January 1999. The Agency believes that azinphos-methyl had not been used on these crops for some time. Consequently, no treated commodities covered by these tolerances are expected to be in the channels of trade. Therefore, EPA is revoking these tolerances because they are not necessary to cover residues in or on domestically treated commodities or commodities treated outside but imported into the United States. Azinphos-methyl is no longer used on these specified commodities within the United States and no person has provided comment identifying a need for EPA to retain the tolerances to cover residues in or on imported foods. EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated. No such comments were received. Therefore, these revocations will be effective 90 days after the publication of this final rule in the Federal Register .

EPA is also removing 40 CFR 180.531, and is revoking the three tolerances found in that section for residues of azinphos-methyl; which are as follows: Sugarcane bagasse, since this commodity is not considered a significant livestock feed item; citrus pulp, dried, since an adequate orange processing study did not show concentration in dried orange pulp (in accordance with FFDCA section 408(a)(2), since residues in the processed food will not exceed the raw food tolerance); and soybean oil, since there are no active registrations with soybean on the label. Therefore, these revocations will be effective 90 days after the publication of this final rule in the Federal Register .

Since the available data indicate that finite residues of azinphos-methyl are not expected in animal tissues or milk, in accordance with 40 CFR 180.6(a)(3) EPA is revoking tolerances found in 40 CFR 180.154(a) for cattle, fat; cattle, mbyp; cattle, meat; goat, fat; goat, mbyp; goat, meat; horse, fat; horse, mbyp; horse, meat; sheep, fat; sheep, mbyp; and sheep, meat; and EPA is revoking 40 CFR 180.154a, the tolerance for milk. The revocation of these 13 meat, milk, poultry and egg (MMPE) tolerances implements the Agency finding as published in the Federal Register on August 2, 1999 (64 FR 41933) (FRL-6097-3), which stated, under 40 CFR 180.6 there is no reasonable expectation of finite residues for azinphos-methyl on the MMPE commodities and, therefore, these tolerances were considered reassessed and could be revoked, because they are not needed.

EPA is removing the tolerance in 40 CFR 180.154(a) for residues of azinphos- methyl in or on nectarines, in accordance with 40 CFR 180.1(h), since the tolerance on nectarines (set at 2.0 ppm) is not necessary, because its use is covered by the tolerance for peaches (also set at 2.0 ppm).

This rule also lowers tolerances found in 40 CFR 180.154(a) for residues of azinphos-methyl in or on almond and potato, each from 0.3 to 0.2 ppm, and in or on almond hulls from 10.3 to 5.0 ppm, since the available data indicate that these tolerances can be lowered to achieve compatibility with the corresponding Codex MRLs. These reductions in tolerances are based on the most recent data that more accurately reflect residue levels that are likely to be detected.

Codex MRLs exist for the following tolerances, i.e. apricot at 2.0 ppm, cereal grains at 0.2 ppm, kiwi fruit at 4.0 ppm, and soya bean at 0.2 ppm. Notwithstanding the existence of these MRLs, EPA is revoking the tolerances because retention would increase the chances of misuse and may result in unnecessary restriction on trade of pesticides and foods as well as inhibiting the retention and approval of tolerances, as discussed in greater detail in Unit II.B., below.

Additionally, in this final rule, EPA is changing commodity terminology and definitions for several commodities to conform to current Agency practice. These changes are in accordance with the revised Crop Group Regulation (40 CFR 180.41) and the updated Table I “Raw Agricultural and Processed Commodities and Feedstuffs Derived from Crops” (August, 1996) in the Residue Chemistry Test Guidelines: OPPTS 860.1000 (EPA 721-C-96-169). Table I contains data on both crops and livestock diets, and lists feed commodities considered significant in livestock diets. Significant feedstuffs account for more than 99 percent of the available annual tonnage (on a dry-matter basis) of feedstuffs used in the domestic production of more than 95 percent of beef and dairy cattle, poultry, swine, milk, and eggs. The EPA has devised criteria to include or exclude feedstuffs from Table I and set tolerances for significant feedstuffs. Tolerances are not set for feedstuffs which are neither significant nor a human food. Pesticide residues on such feedstuffs are governed by tolerances on the commodity from which they are derived (62 FR 66020, December 17, 1997) (FRL-5753-1). These changes relate only to nomenclature and have no effect on the scope of the tolerance. The specific commodity terminology name changes are listed in the table as follows:

Please note that a few typographical errors were made in the proposed rule that are corrected in this final rule. Unit II.F. should have read as Unit II.C. Also, the parts per million value for crabapple was listed incorrectly in the codification section as 2.0 parts per million, while it was listed correctly in the preamble as 1.5 parts per million.

The regulatory actions in this document are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA).

It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.

Furthermore, as a general matter, the Agency believes that retention of tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under section 408 of the FFDCA, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid these trade-restricting situations, the Agency is revoking tolerances for residues on crop uses for which FIFRA registrations no longer exist. Through the proposed rule, the Agency invited individuals who may have needed these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities. No responses were received.

Under section 408(d) of the FFDCA, the Agency may issue a final or proposed regulation establishing, modifying, or revoking a tolerance in response to a petition filed with the Agency that proposes the issuance of such regulation. On August 2, 1999, EPA and the registrants holding Section 3 registrations for azinphos-methyl signed a Memorandum of Agreement (MOA), which specifically states that the registrants shall submit to EPA a petition requesting many of the tolerance modifications detailed in this proposal; i.e. lowering tolerances on apples, crabapples, cranberries, grapes, pears, and quinces, and revoking the tolerance on sugarcane. Such a petition has been received by the Agency, dated September 22, 1999. Thus, the Agency is authorized by section 408(d) of the FFDCA to issue a proposed regulation in response to that petition. The MOA was made to help mitigate acute dietary, agricultural worker, and environmental risks. During phase five of the Tolerance Reassessment Advisory Committee (TRAC) process, the Agency invited the registrants, and any other affected or interested parties, to submit to the Agency additional risk mitigation thoughts or measures, since the acute dietary risk estimates from the revised human health risk assessment remained above the Agency's level of concern. The revised human health risk assessment may be found at http://www.epa.gov/pesticides/op. In addition to the MOA, EPA is also revoking or lowering other tolerances, as well as changes in commodity nomenclature for various reasons as described in Unit II of this document.

By law, EPA is required to reassess 66%, or about 6,400, of the tolerances in existence on August 2, 1996, by August 2002. EPA is also required to assess the remaining tolerances by August 2006. As of 11/1/99, EPA has assessed over 3,400 tolerances. This document revokes 35 tolerances and removes 1 tolerance, which is not considered a revocation nor considered reassessed at this time. Since 13 tolerances were previously counted as reassessed, 22 of the 35 revocations are counted as reassessed in this final rule. The 22 reassessments are being counted toward the August, 2002 review deadline of FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996.

These actions become effective 90 days following publication of this final rule in the Federal Register . EPA has delayed the effectiveness of these revocations for 90 days following publication of a final rule to ensure that all affected parties receive notice of EPA's actions. Consequently, the effective date is September 20, 2000; except for the tolerance on sugarcane, which expires on June 30, 2000.

Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(l)(5), as established by the FQPA. Under this section, any residue of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that, (1) the residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and (2) the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.

EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs. The U.S. EPA has developed guidance concerning submissions for import tolerance support. This guidance will be made available to interested persons.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301003 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 August 21, 2000.

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

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C-400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IV.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301003, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format 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; 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 will revoke tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action, i.e., a tolerance revocation for which extraordinary circumstances do not exist, from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning azinphos-methyl, I certify that this action will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with the revoked pesticides, generally within the same countries from which the relevant commodities are currently imported. Furthermore, no extraordinary circumstances exist as to the present revocation that would change EPA's previous analysis.

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 rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

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

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

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

2. In person. The Agency has established an official record for this action under docket control number OPP-300924. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of June 26, 1998 (63 FR 34390-34392) (FRL-5794-9), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of a pesticide tolerance petition by Makhteshim Agan of North America, (hereafter referred to as MANA), 551 Fifth Avenue, Suite 1100, New York, NY 10176. This notice included a summary of the petition prepared by the petitioner, MANA. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Trichoderma harzianum Rifai strain T-39.

New Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...” Additionally, section 408(b)(2)(D) requires that the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residue and “other substances” that have a common mechanism of toxicity.

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide us in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Trichoderma harzianum strain T-39 was considered neither toxic nor pathogenic based on the results of the Tier I toxicology studies. Tier II and Tier III studies were not required because the results from the Tier I studies were sufficient to satisfy guideline requirements. On the basis of the studies submitted, it was considered a Toxicity Category III pesticide for acute oral effects due to the amount dosed only, and Toxicity Category IV for dermal and primary dermal irritation health effects. These and additional toxicology studies are summarized below.

1. Acute oral infectivity/pathogenicity. Based on the submitted data, Trichoderma harzianum strain T-39 demonstrated a low toxicity profile. It was not infectious, pathogenic or toxic to rats when administered orally at 1.4 to 2.0 × 10 8 colony forming units (cfu) per animal. Clearance and infectivity were evaluated in the brain, blood, lymph nodes, kidney, liver, spleen, lungs, caecum and feces. The microbe was detected only in fecal samples, and in those samples a distinct clearance pattern was demonstrated throughout the study.

2. Acute dermal toxicity. A single 1,150-1,570 mg/kg dose of Trichoderma harzianum was applied dermally for a 24 hour exposure period to rabbits. There were no clinical signs of toxicity and no effects on mortality or body weight nor any signs of dermal irritation during the study. The available information indicates that dermal toxicity is not likely to occur with Trichoderma harzianum strain T-39.

3. Primary Dermal Irritation Study. A dermal application of 0.5g of Trichoderma harzianum strain T-39 at 5 × 10 9 cfu/g produced no dermal response in rabbits after a 4-hour exposure period. The results of this study are classified as Supplementary, but taken in conjunction with the acute dermal toxicity study, the microbial pesticide is likely to be mildly irritating to skin. The pesticide was classified as Toxicity Category IV for primary dermal irritation effects.

4. Skin sensitization in guinea pig. Under the conditions of this study, Trichoderma harzianum strain T-39 in physiological saline was applied in occluded dermal patches. This study demonstrated potential delayed contact hypersensitivity in guinea-pigs. This study was designed to meet the requirements of the OECD Guidelines for Testing Chemicals, and was submitted in support of fulfilling EPA data requirements for hypersensitivity incidents. While the study is not a substitute for reporting hypersensitivity incidents, it was considered acceptable. However, the registrant must report any hypersensitivity incidents to the Agency. The label must indicate that products containing this active ingredient are likely to demonstrate a potential for dermal sensitization.

5. Primary eye irritation. Three eye irritation studies were submitted. Two acute eye irritation studies were conducted using undiluted TGAI on a single male rabbit each time. The studies indicated a potential for severe eye irritation, placing the undiluted TGAI in acute Toxicity Category I. In one study, a single dose of 0.1g of the active ingredient, approximately 5 × 10 8 cfu, was used to treat one rabbit. The results indicated that the microbial pest control agent (MPCA) TGAI, Trichoderma harzianum strain T-39, has the potential to cause serious ocular damage. The active ingredient was a severe eye irritant. In another study a single dose of 0.1g was administered into the everted lower right eyelid of a sentinel male rabbit. The results of this study indicated that a 3 minute, 180 ml saline rinse, applied 3 minutes post dosing, had no ameliorating effect on the irritancy of the active ingredient. The adhesion of the TGAI to the conjunctivae remained a serious effect of treatment even after rinsing.

However, another eye irritation study was done in which the test material was the End-use Product (EP), Trichodex. Six male rabbits were treated with a single dose of 0.1 ml (0.04 g) of Trichodex-EP into the everted lower right eyelid. The maximum average irritation score was determined to be 15.3 at 24 hours post dosing. There was no corneal involvement after 72 hours and ocular irritation was no longer present after 7 days, equivalent to a mildly irritating, or an acute Toxicity Category III rating for the EP. This study was considered acceptable and can be used for labeling of the EP. Workers, who are most likely to be exposed to the pesticide during mixing/loading, application and post application activities, are required to wear goggles to mitigate against potential eye irritation.

6. Acute intraperitoneal toxicity/pathogenicity. Under conditions of this study the LD 50 for the EP, Trichodex, administered via intraperitoneal injection was 644 mg/Kg in male rats, 1.087 mg/Kg in female rats and 806 mg/Kg for combined results from male and female rats. The lowest dose administered, 1.5 × 10 7 cfu/animal, showed no indications of significant adverse effects. This study was considered acceptable and is a substitute for the intravenous study with fungi as active pesticidal ingredients.

7. Acute pulmonary toxicity/pathogenicity. Small 2 mm pale raised areas were found in the lungs of some animals of both genders treated with test material containing the active fungi. However, minimal clinical signs and no deaths were observed. There were no significant macroscopic lesions found in any test animals in the other experimental groups. The active ingredient was not found in samples of liver, brain, spleen, kidneys, lymph nodes or blood. Microbial clearance through the caecum was evident. Although there was no evidence of the reproduction of the microbe in the tissues, colony forming units persisted in the lungs of animals treated with the active fungus. However, no adverse effects were seen even in the absence of lung clearance by day 21. Based on this study the TGAI was classified as Toxicity Category III. Because the predominant inert ingredient is known to have associated irritation and inhalation effects, the microbial, EP was classified as an acute Toxicity Category II pesticide or likely to be a moderate acute inhalation hazard. Workers who are most likely to be exposed during mixing/loading, application and post application activities are required to wear the recommended respirators with NIOSH prefixes, N-95, P-95 or R-95, to mitigate against exposure.

8. Mouse Micronucleus Test. This study is not required under the guidelines for registration of microbials but was submitted by the registrant for consideration of the application. A preliminary toxicity test using doses of 2,500 and 5,000 mg/Kg resulted in no deaths and no significant chromosome damage. Subsequently, the main study was carried out with administration of Trichodex suspended in 0.5% methyl cellulose solution by oral gavage. Doses were 200, 1,000, or 5,000 mg/kg. Under conditions of this test, there was no evidence of chromosomal damage leading to micronucleus formation in polychromatic erythrocytes of treated mice 24, 48, or 72 hours after dosing. The study was rated supplemental.

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

Dietary exposure to the microbial pesticide is likely to occur. The lack of acute oral toxicity/pathogenicity, and the ubiquitous nature of the microbial, support the establishment of an exemption from the requirement of a tolerance for Trichoderma harzianum strain T-39.

1. Food . The microbial pesticide can be removed from foods by washing, peeling, cooking and processing. Dietary exposure to the microbial and the risk posed to adults, infants and children are likely to be minimal, because of the low acute oral toxicity/pathogenicity potential of the microbial pesticide.

2. Drinking water exposure. Oral exposure, at very low levels, may occur from ingestion of drinking water. Drinking water is not being screened for Trichoderma harzianum as a potential indicator of microbial contamination. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of exposure to the fungal active ingredient through drinking water. Therefore, the potential of significant transfer of residues to drinking water is minimal to non-existent. Even if negligible oral exposure should occur through drinking water, the Agency concludes that such exposure would present no risk due to the lack of acute oral toxicity/pathogenicity and the ubiquitous nature of the microbe.

Dermal and inhalation exposure . Dermal and inhalation exposures and risks to adults, infants and children via treated lawns or recreational areas are not likely if the pesticide is applied as labeled. However, should such exposures occur, adverse effects via the dermal and inhalation routes are expected to be minimal based on the low toxicity potential of this naturally occurring, ubiquitous microbe.

There are other species and strains of Trichoderma registered. The Agency has received information to distinguish strain T-39 from other registered strains. It is not clear to the Agency whether the registered strains share a common mechanism of toxicity, or any mechanism of toxicity with strain T-39. Because the data available demonstrate a low toxicity/pathogenicity potential of the active ingredient, the likelihood of adverse dietary effects is expected to be minimal.

Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to the U.S. population to Trichoderma harzianum Rifai strain T-39 residues. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has imposed appropriate risk mitigation measures to protect the at-risk worker population from potential eye irritation and acute pulmonary effects. These include goggles and appropriate dust-mist filtering respirators which comply with the Worker Protection Standards.

EPA does not have any information regarding endocrine effects of this microbial pesticide at this time. There is no evidence to suggest that use of Trichoderma harzianum strain T-39 at the proposed concentrations will adversely affect the endocrine system.

As part of the standard Quality Control measures, the Agency is requiring microbial assays and analytical methods to identify the active ingredient and potential contaminants. Analytical methods are available and sufficient to identify metabolites and contaminants within regulatory levels. All batches containing potential human pathogens are to be destroyed.

There are no Codex Maximum Residue Levels or exemption from tolerances for the microbial active ingredient Trichoderma harzianum strain T-39. There is an exemption from tolerance on all food commodities except mushrooms for another strain of Trichoderma harzianum , Rifai strain KRL-AG2, in the United States.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-300924 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 August 21, 2000.

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

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Room C-400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission be 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, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A. of this preamble, you should also send a copy of your request to the PIRB for its inclusion in the official record that is described in Unit I.B.2. of this preamble. Mail your copies, identified by docket number OPP-300924, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PRIB described in Unit I.B.2. of this preamble. 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 file format 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 will establish an exemption from the tolerance requirement under FFDCA section 408(e). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency previously assessed whether establishing tolerances, exemptions from tolerances, raising tolerance levels or expanding exemptions might adversely impact small entities and concluded, as a generic matter, that there is no adverse economic impact. The factual basis for the Agency's generic certification for tolerance actions published on May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. 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 rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

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

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

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

2. In person . The Agency has established an official record for this action under docket control number OPP-301010. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of April 15, 1998 (63 FR 18417) (FRL-5781-9), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP 7E4920) for tolerances by Novartis Crop Protection, Inc., P.O. Box 18300, Greensboro, North Carolina 27419. This notice included a summary of the petition prepared by Novartis Crop Protection, Inc., the petitioner. The petition was subsequently amended to increase the original proposed tolerances and an additional notice of filing was published in the Federal Register on April 19, 2000 (65 FR 20972). There were no comments received in response to the notice of filing.

The April 19, 2000 (FRL-6554-3) petition requested that 40 CFR part 180 be amended by establishing tolerances for combined residues of the inert ingredient (herbicide safener) cloquintocet-mexyl (acetic acid, [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) and its acid metabolite (5-chloro-8-quinolinoxyacetic acid), in or on wheat, grain at 0.1 parts per million (ppm); wheat, forage at 0.1 ppm; and wheat, hay at 0.1 ppm and wheat, straw at 0.1 ppm.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for combined residues of cloquintocet-mexyl and its acid metabolite) on wheat, grain at 0.1 ppm; wheat, forage at 0.1 ppm; wheat, hay at 0.1 ppm; and wheat, straw at 0.1 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 cloquintocet-mexyl are discussed in this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

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

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

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

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

In accordance with the Proposed EPA Weight-of-the-Evidence Categories, August 1999, the Agency classified cloquintocet-mexyl as “not likely to be a human carcinogen”. Carcinogenicity studies in rats and mice did not show increased incidence of spontaneous tumor formation. With negative mutagenicity test battery, it is suggested that cloquintocet-mexyl is not likely to be a human carcinogen.

1. Dietary exposure from food and feed uses . No tolerances have previously been established for the combined residues of cloquintocet-mexyl and its acid metabolite 5-chloro-8-quinolinoxyacetic acid. A risk assessment was conducted by EPA to assess dietary exposures from cloquintocet-mexyl and its acid metabolite in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Agency has conducted Tier 1 acute food exposure assessments for cloquintocet-mexyl using the Dietary Exposure Evaluation Model (DEEM). This model incorporates consumption data generated in USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-1992. For this acute food risk assessment, the entire distribution of single day food consumption events is combined with a single residue level (deterministic analysis ) to obtain a distribution of exposure in mg/kg/day. For a Tier 1 analysis, the Agency considers exposure at the 95th percentile of exposure. The following assumptions were made for the Tier 1 acute exposure assessment: (1) Residues of cloquintocet-mexyl and its acid metabolite would be present in/on wheat at the tolerance level (0.1 ppm); and (2) 100% of the wheat crop would be treated.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. For chronic food risk assessments, the three-day average of consumption for each sub-population is combined with residues in commodities to determine average exposure in mg/kg/day. The following assumptions were made for the chronic exposure assessments: (1) Residues of cloquintocet-mexyl and its acid metabolite would be present in/on wheat at the tolerance level (0.1 ppm); and (2) 100% of the wheat crop would be treated.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for cloquintocet-mexyl and its acid metabolite 5-chloro-8-quinolinoxyacetic acid 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 cloquintocet-mexyl and its acid metabolite.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) 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.

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

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to cloquintocet-mexyl and its acid metabolite 5-chloro-quinolinoxyacetic acid they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of cloquintocet-mexyl in surface water and ground water for acute exposures are estimated to be 0.038 parts per billion (ppb) for surface water and 0.0060 ppb for ground water. The EECs for chronic exposures are estimated to be 0.0053 ppb for surface water and 0.0060 ppb for ground water. The EECs for ground water for the acid metabolite for acute and chronic exposures are estimated to be 0.00017 ppb. The EEC for surface water for acute exposure for the acid metabolite is estimated to be 0.031 ppb, while the chronic exposure is estimated to be 0.017 ppb for surface 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). Cloquintocet-mexyl is not registered for use on any sites that would result in residential exposure.

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

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

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

ii. Prenatal and postnatal sensitivity . There was no evidence of developmental or reproductive toxicity for cloquintocet-mexyl. The data demonstrate no increased sensitivity of rats or rabbits to in utero or early post-natal exposure to cloquintocet-mexyl. NOAELs for maternal/parental toxicity were either less than or equal to the NOAELs for fetal or reproductive toxicity.

iii. Conclusion . There is a complete toxicity data base for cloquintocet-mexyl. Exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA has determined that the 10X safety factor to protect infants and children should be removed (i.e., reduced to 1X) because the toxicology database (i.e., developmental toxicity studies in rats and rabbits; 2-generation reproduction study in rats) is complete, and there is no indication of quantitative or qualitative increased susceptibility of rats or rabbits in the available toxicity data.

The following text is based on the assumption that water models were used to estimate residues in drinking water. If exposure to residues in drinking water is not expected, delete the following three paragraphs. If exposure is based on monitoring data, the text must be revised.

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

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to cloquintocet-mexyl and its acid metabolite will occupy < 1.0 % of the aPAD for females 13-50 years. In addition, there is potential for acute dietary exposure to cloquintocet-mexyl and its acid metabolite in drinking water. The acute DWLOC for the population subgroups females of child-bearing age is 30,000 ppb. After calculating the acute DWLOC and comparing the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD since the DWLOC greatly exceeds the EEC.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to cloquintocet-mexyl and its acid metabolite from food will utilize < 1 % of the cPAD for the U.S. population, infants (< 1 year), and male and female adult populations. Exposure from food will utilize 1 % of the cPAD for children (1-6) and (7-12 years). There are no residential uses for cloquintocet-mexyl that result in chronic residential exposure.

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

Cloquintocet-mexyl 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. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). There are no established residential uses for cloquintocet-mexyl.

Cloquintocet-mexyl 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.

5. Aggregate cancer risk for U.S. population.Cloquintocet-mexyl is classified as “not likely” to be a human carcinogen . Therefore, cloquintocet- mexyl is not expected to pose a cancer risk.

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

The petitioner has proposed residue analytical methods for tolerance enforcement that use high performance liquid chromatography with UV detection (HPLC-UV). These methods are currently being validated by the Analytical Chemistry Branch laboratories, BEAD (7503C), Office of Pesticide Programs. Upon successful completion of the EPA validation, these methods will be forwarded to FDA for publication in a future revision of the Pesticide Analytical Manual. Vol-II (PAM-II). Prior to publication in PAM-II and upon request, the methods will be available prior to the harvest season from the Analytical Chemistry Branch (ACB), BEAD (7503C), Environmental Science Center, 701 Mapes Road, Fort George G. Meade, MD 20755-5350; contact Francis D. Griffith, Jr., telephone (410) 305-2905, e-mail griffith.francis @epa.gov. The analytical standards for these methods are also available from the EPA National Pesticide Standard Repository at the same location.

There are no Codex, Canadian, or Mexican tolerances for cloquintocet-mexyl on wheat. Therefore, no compatibility issues exist.

The following residue chemistry data gaps have been identified for cloquintocet mexyl: (1) additional wheat metabolism data; (2) additional information on meat, milk, poultry, and egg analyses; (3) storage stability data; and (4) additional field trial residue studies. Because of these deficiencies, the Agency incorporated several conservative assumptions into the risk assessment for cloquintocet-mexyl. The Agency believes that the available data and risk assessment support the determination that there is a reasonable certainty of no harm and the establishment of permanent tolerances for cloquintocet-mexyl.

Cloquintocet-mexyl will be used with the active ingredient, clodinafop-propargyl. The registration of clodinafop-propargyl will be time-limited and conditional upon submission of additional information/data to satisfy certain toxicology, residue chemistry, ecological effects, and environmental fate data deficiencies. Several guideline requirements are either data gaps or are only partially fulfilled, and the additional information is required to confirm and/or refine the parameters of the Agency's risk assessment. The required data for both cloquintocet-mexyl and clodinafop-propargyl must be submitted to maintain this registration.

Therefore, the tolerances are established for combined residues of cloquintocet-mexyl (acetic acid, [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) and its acid metabolite (5-chloro-8-quinolinoxy acetic acid), in or on wheat, grain at 0.1 ppm (parts per million); wheat, forage at 0.1 ppm; wheat, hay at 0.1 ppm; and wheat, straw at 0.1 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301010 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 August 21, 2000.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301010, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

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

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

2. In person . The Agency has established an official record for this action under docket control number OPP-301009. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of April 26, 2000 (65 FR 24471-24477) (FRL- 6554-2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the amended filing of a pesticide petition (PP) for tolerance by Novartis Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. This notice included a summary of the petition prepared by Novartis Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for combined residues of the herbicide clodinafop-propargyl (propanoic acid, 2-[4-[(5-chloro-3-fluoro-2-pyridinyl)oxy]phenoxy]-,2-propynyl ester, (2R)-) and its acid metabolite, CGA-193469, (propanoic acid, 2-[4-[(5-chloro-3-fluoro-2-pyridinyl)oxy]phenoxy]-, (2R)-), in or on wheat, grain at 0.1 part per million (ppm); wheat, forage at 0.1 ppm; wheat, hay at 0.1 ppm; and wheat, straw at 0.5 ppm.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of clodinafop-propargyl and its acid metabolite on wheat, grain at 0.1 ppm; wheat, forage at 0.1 ppm; wheat, hay at 0.1 ppm; and wheat, straw at 0.5 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 clodinafop-propargyl are discussed in this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

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

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

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

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

Carcinogenicity. In accordance with the EPA Proposed EPA Weight-of-the-Evidence Categories , August 1999, the Agency's Cancer Assessment Review Committee (CARC) classified clodinafop-propargyl as “likely to be carcinogenic to humans” by the oral route based on the occurrence of prostate tumors in male rats, ovarian tumors in female rats, and liver tumors in both sexes of mice, as well as blood vessel tumors in female mice. For the quantification of human cancer risk, the CARC recommended a linear low-dose extrapolation approach based on the most potent of these tumor types. This approach is supported by possible genotoxic potential and the lack of confirmation of the mode of action of clodinafop-propargyl. The most potent unit risk, Q 1 * (mg/kg/day) -1 , of those calculated for clodinafop-propargyl is that for male mouse liver benign hepatoma and/or carcinoma combined tumor rates at 0.129 (mg/kg/day) -1 in human equivalents.

1. Dietary exposure from food and feed uses . No tolerances have previously been established for clodinafop-propargyl. Risk assessments were conducted by EPA to assess dietary exposures from clodinafop-propargyl in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: (1) residues of clodinafop-propargyl and its acid metabolite would be present in/on wheat at the tolerance level (0.1 ppm); and (2) 100% of the wheat crop would be treated.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: (1) residues of clodinafop-propargyl and its acid metabolite would be present in/on wheat at the anticipated residue level of 0.07 ppm; and (2) 4 percent of the wheat crop would be treated. The anticipated residue value of 0.07 ppm was derived from the sum of the limit of quantitation (LOQ) of clodinafop-propargyl (0.02 ppm) plus the LOQ of the acid metabolite (0.05 ppm) in/on wheat grain. The percent crop treated value of 4% assumes that the target pest, wild oats, occurs on 10% of the wheat acreage and that 40% of the affected acreage could be treated.

iii. Cancer . A lifetime cancer risk assessment was performed for the U.S. total population. Lifetime cancer risk was estimated by applying the Q 1 * value of 0.129 (mg/kg/day) -1 to the chronic dietary exposure estimate.

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

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

The Agency used PCT information as follows:

A routine chronic dietary exposure analysis for clodinafop-propargyl was based on 4% of the wheat crop treated, derived as follows. Of the approximately 63 to 70 million acres of wheat grown in the United States, about 6.5 million acres of wheat (or approximately 10% of the total) are treated to control the target pest, wild oats. The petitioner expects to capture up to 40% of the available market, or 2.5 million acres, representing 4% of the total U.S. wheat crop (40% × 10% = 4%).

The Agency believes that the three conditions previously discussed have been met. With respect to Condition 1, EPA finds that the PCT information described above for clodinafop-propargyl used on wheat is reliable and has a valid basis. The PCT information is based on reliable estimates of the potential market for clodinafop-propargyl and the petitioner's estimate of the market share it expects to capture. EPA believes the petitioner's estimate is an overestimate. At the present time, there are several competing products, making it very unlikely that the petitioner will gain 40% of the available market when it enters the market. The use of 4% in the chronic dietary exposure assessment is, therefore, considered conservative. 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 clodinafop-propargyl 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 clodinafop-propargyl and its acid metabolite 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 clodinafop-propargyl and its acid metabolite.

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

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

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

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of clodinafop-propargyl in surface water and ground water for acute exposures are estimated to be 0.23 parts per billion (ppb) for surface water and 5 × 10 -6 ppb for ground water. The EECs for chronic exposures are estimated to be 0.0017 ppb for surface water and 5 × 10 -6 ppb for ground water. The estimated environmental concentrations (EECs) of the acid metabolite, CGA-193496, in surface water and ground water for acute exposures are estimated to be 1.1 ppb for surface water and 0.044 ppb for ground water. The EECs for chronic exposures are estimated to be 0.11 ppb for surface water and 0.044 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).

Clodinafop-propargyl is not registered for use on any sites that would result in residential exposure.

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

EPA does not have, at this time, sufficient data to determine whether clodinafop-propargyl has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this tolerance action, therefore, EPA has not assumed that clodinafop-propargyl has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

ii. Prenatal and postnatal sensitivity . The Agency concluded that there is concern for the increased susceptibility of infants and children to exposure to clodinafop-propargyl based on the developmental toxicity study in rats where increased skeletal effects were observed at doses much lower (LOAEL of 40 mg/kg/day) than the maternal NOAEL (160 mg/kg/day). Although there was no evidence of reproductive toxicity, a fetotoxic effect was noted in the two-generation reproduction study in rats since reduced fetal viability, decreased pup body weight, and dilatation of renal pelvis were observed in the offspring at doses that produced relatively minimal parental toxicity (decreased body weight gain, increased liver and kidney weights with histopathological changes).

iii. Conclusion . The toxicology database for clodinafop-propargyl is incomplete. Acute neurotoxicity, subchronic neurotoxicity, developmental neurotoxicity and in vitro cytogenetics studies are required. There is quantitative evidence of increased susceptibility of the young following in utero exposure to clodinafop-propargyl in the prenatal developmental study in rats, and there is concern for qualitative increased susceptibility in the 2-generation reproduction study in rats. A developmental neurotoxicity study has been required based on the evidence of potential endocrine disruption in the mechanism studies with clodinafop-propargyl.

For the reasons given above, the Agency concluded that the FQPA safety factor be retained at 10x. When assessing acute dietary exposure, the safety factor is retained at 10x for the females 13-50 years old population subgroup since there are data gaps in the toxicology database for clodinafop-propargyl including a developmental neurotoxicity study and there is quantitative evidence of increased susceptibility following in utero exposure to clodinafop-propargyl in the prenatal developmental study in rats.

The safety factor can be reduced to 3x for the infants and children population subgroups when assessing acute dietary exposure since the increased susceptibility observed following in utero exposure is only of concern for females of childbearing age leaving only the uncertainty due to the data gap for the developmental neurotoxicity study.

The safety factor can be reduced to 1x for all other populations subgroups not included in females 13-50 years old and infants and children when assessing acute dietary exposure. The increased susceptibility observed following in utero exposure is only of concern for females of childbearing age. The data gap for developmental neurotoxicity is of concern for infants and children.

When assessing the chronic dietary exposure, the safety factor should be retained at 10x for all population subgroups since there is concern for qualitative increased susceptibility of the young demonstrated after repeated oral exposures in the 2-generation reproduction study and since there are data gaps in the toxicology database including a developmental neurotoxicity study in rats.

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 population adjusted dose (PAD)) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD—(average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to clodinafop-propargyl will occupy <1.0% of the aPAD for the U.S. population, 7.5% of the aPAD for nursing females 13 years and older, the subgroup of adult females with the highest estimated exposure, and 1.0% of the aPAD for children 1 to 6 years old, the subgroup of infants and children with the highest estimated exposure. In addition, there is potential for acute dietary exposure to clodinafop-propargyl 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.

EPA Region 5 announces the deletion of 3.45 acres of the Motor Wheel Disposal Superfund Site from the National Priorities List (NPL), appendix B of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300. EPA identifies sites that appear to present a significant risk to public health, welfare and the environment, and maintains the NPL as the list of those sites. Sites on the NPL may be the subject of remedial actions that the Hazardous Substance Superfund Response Trust Fund (Fund) finances. Under § 300.425(e)(3) of the NCP, any site or portion of site deleted from the NPL remains eligible for Fund-financed remedial actions if the conditions at the site warrant such action.

EPA will accept comments on this proposal for thirty (30) days after publication of this document in the Federal Register .

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the history of this site and explains how a portion of the Site meets the deletion criteria. Section V states EPA's prospective action of deleting a portion of the Site from the NPL unless dissenting comments are received during the comment period.

Deletion or partial deletion of sites from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Furthermore, deletion from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist in Agency management.

Section 300.425(e) of the NCP provides that Sites may be deleted from, or recategorized on, the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the state, whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required; or

(ii) All appropriate Fund-financed responses under CERCLA have been implemented, and no further response action by responsible parties is appropriate; or

(iii) The Remedial Investigation has shown that the release poses no significant threat to public health or the environment and, therefore, remedial measures are not appropriate.

The following procedures were followed before the proposed partial deletion of this Site from the NPL: (1) The RI has shown that the 3.45 acres of the Motor Wheel Disposal Site poses no significant threat and therefore, remedial measures are not appropriate; (2) the State of Michigan has concurred with the proposed deletion decision; (3) a notice has been published in the local newspaper and has been distributed to appropriate federal, state, and local officials and other interested parties announcing the commencement of a 30-day dissenting public comment period on EPA's Direct Final Action for Partial Deletion; and, (4) all relevant documents have been made available for public review in the local Site information repositories. EPA is requesting only dissenting comments on the Direct Final Action for Partial Deletion.

For partial deletion of the Site, EPA's Regional Office will accept and evaluate public comments on EPA's Final Notice. If necessary, the Agency will prepare a Responsiveness Summary, responding to each significant comment submitted during the public comment period. As stated in section I above, deletion or partial deletion of the Site from the NPL does not itself create, alter, or revoke any individual's rights of obligations. The NPL is designed primarily for informational purposes and to assist Agency management.

Motor Wheel is a 24-acre site located on the northeast edge of the City of Lansing within the NE 1/4 ,SW 1/4 , section 3 of Lansing Township (T.4N., R.2W.), Ingham County, Michigan. The Site is bordered by abandoned Michigan Central Railroad tracks to the west and north, by the W.R. Grace & Co. plant (formerly Michigan Fertilizer Company) to the south, and by the Lansing/Lansing Township boundary to the east.

The property was used by Motor Wheel Corporation as a disposal site for industrial wastes from 1938 until about 1978. The types of disposed wastes included, solid and liquid industrial wastes, including paints, solvents, liquid acids and caustics, sludges and other wastes. Wastes were disposed of on the property in tanks, barrels, and seepage pond areas for off-site disposal.

In December of 1982 there was a removal of three 10,000 gallon tanks and their contents, and degraded fill material from several locations on the Site. At the Motor Wheel Disposal Site, the RI has shown that the 3.45 acres are no threat to public health or the environment. The three tanks and approximately 800 cubic yards of contaminated soil and fill surrounding them, and approximately 350 cubic yards of fill material containing an unknown number of drums, were disposed of off site.

All operations at the Site were discontinued in 1987. The entire Site is currently inactive. MSV & Associates, which purchased the Site in 1978 and mined sand and gravel in the northeast portion of the property until 1987, is the current owner of the property. The key surface feature of the Site, the sand and gravel pit extending over the northern portion of the Site, is the result of earlier quarrying activities. The pit area, excavated to a depth of 50 feet, has relatively steep sided walls and a slope ranging from 2:1 (horizontal:vertical) to near vertical. There are several small ponds in the eastern part of the pit bottom.

EPA issued a ROD September 30, 1991 selecting a remedy that includes the following major elements:

• Construction of a landfill cap in the area of waste disposal.

• Construction and operation of a collection system to contain and extract ground water contaminated by Site related hazardous constituents.

• Construction and operation of a treatment plant to treat contaminated ground water prior to surface discharge.

Design of the multimedia cap, which covers the entire fill area is based on the specifications of Michigan Act 64. The cap also meets and exceeds the requirements for a RCRA subtitle C cap. The cap covers about 11.3 acres of waste area including additional backfilled areas which are necessary to maintain the cap's integrity. The capped area totals about 14.9 acres. The capped area is fenced to restrict access. The 3.45 acres are located outside of the capped area. The Site is defined as the parcel of land in the East 1/2 of the Southwest 1/4 of section 3, T4N, R2W, City of Lansing, Ingham County, Michigan; the boundary of said parcel being described as commencing at the South 1/4 Corner of section 3, T4N, R2W, Michigan Meridian; thence N 00°00′01″ W, along the North-South 1/4 line of said Section, 1310.21 feet to the centerline of Lake Lansing Road and to the point of beginning; thence S 48°58′00″ W, along the centerline of Lake Lansing Road, 9.46 feet; thence S 89°46′42″ W, along the North line of the Plat of Park Manor Heights, 224,75 feet; thence N 18°44′17″ 100.00 feet; thence N 08°10′31″ W, 7097 feet; thence N 02°35′23″ W, 379.08 feet; thence N 88°30′21″ E, 291.32 feet; thence S 00°00′01″ E, along the North-South 1/4 line of said section, 544.16 feet to the point of beginning; said parcel contains the 3.45 acres of land which is intended for deletion.

The ROD, based on information provided in the Remedial Investigation (RI), included a provision for the collection and treatment of contaminated groundwater from an on-site perched aquifer and from the glacial aquifer below and in the near vicinity of the Site. The ROD also indicated the potential for additional remediation to address any contamination which may have entered the bedrock aquifer.

A special notice letter was issued to the PRP's on December 10, 1991. The negotiations which followed the PRP's good faith offer, resulted in an agreement to proceed with a Remedial Design (RD) under an Administrative Order on Consent (May 26, 1992); a letter of intent from PRP's to enter into the negotiated Remedial Action (RA) Consent Decree; and extension of the moratorium to accommodate the Respondents desire to resolve internal allocation issues through arbitration prior to signing the Consent Decree. This agreement also included the PRP's declared intention to continue investigation of water quality in the bedrock aquifer and to address contamination in the bedrock aquifer, if any, in this action. The RA Consent Decree was entered April 22, 1994.

Groundwater investigations conducted in conjunction with pre-design studies indicated a more extensive area of groundwater contamination within the glacial aquifer extending about 7200 feet down gradient from the Site and geologic conditions which showed a potential pathway for migration of contaminants from the glacial to the bedrock aquifer.

An additional investigation of water quality in the bedrock aquifer was also a part of the predesign study. Results of this investigation summarized in The Investigation of the Saginaw Aquifer at the Motor Wheel Disposal Site, November 1996 indicated that levels of some site related contaminants in the bedrock aquifer exceed drinking water standards. On the basis of this information the design of the groundwater collection and treatment system was expanded to accommodate the expected volume from the bedrock aquifer. The RI did not show contaminated groundwater beneath the 3.45 acres.

The RD conducted in accordance with the ROD and the approved RD Work Plan was approved by EPA and the RA was formally initiated by PRP contractors July 25, 1997. All remedial activities were conducted as planned. EPA and the State conducted pre-final inspections. The inspection report includes a description and a schedule for correcting minor construction items by the PRP contractor. EPA and the State determined that the following RA activities were completed according to ROD design specifications:

• Construction of an engineered cap which meets applicable or relevant and appropriate requirements over the on-site waste disposal area;

• Construction of an extraction and collection system to contain groundwater in the perched, glacial and bedrock aquifers which contain site related hazardous constituents;

• Construction of an on-site facility for treatment of contaminated groundwater; and

• Construction of a main system for discharge of treated groundwater.

The groundwater extraction and treatment system began operation November 20, 1997 and is scheduled to continue until cleanup standards have been achieved.

EPA, with the State of Michigan concurrence, has determined that no responses are necessary at the 3.45 acres which comprise a portion of the Motor Wheel Disposal Site, and no further CERCLA response is appropriate or necessary in order to provide protection of human health and the environment other than the ongoing inspection, maintenance and monitoring activities. Therefore, EPA is deleting that portion of the Site which is comprised of 3.45 acres from the NPL.

This action will be effective August 21, 2000. However, if EPA receives dissenting comments by July 24, 2000, EPA will publish a timely withdrawal of the rule in the Federal Register informing the public that the rule will not take effect.

FAC 97-17, dated April 25, 2000, revised FAR 16.504 and 16.505, including the requirement to identify the facsimile and e-mail address of agency task and delivery ombudsman. This final rule revises numbering within NFS 1815, 1816, 1819, and 1852 to reflect the FAC 97-17 changes and update the agency ombudsman information. This final rule also revises sections 1852.216-76 and 1852.216-77 to indicate that award fee determinations are no longer exempt from the Disputes clause as a result of FAC 97-15. Changes unrelated to FAC 97-15 and 97-17 are made to allow precontract costs for awards resulting from broad agency announcements (BAA). The use of precontract costs is currently allowed for sole source contracts, except those resulting in firm fixed-price or fixed-price contracts. Contracts awarded under BAAs are considered competitive based on FAR 6.102(d). However, the award process for BAAs is similar to that for sole source awards since negotiations with the contractor occurs after source selection, rather than prior to selection in the normal competitive contract award process. Because of the selection process under BAAs, it is reasonable to allow the approval of precontract costs. Additionally, an editorial change is made to correct the title of paragraph (i)(3) to section 1815.370.

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

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

Prompted by a sharp decline in the estimated abundance of CI beluga whales between 1994 (653 animals) and 1998 (347 animals), a reduction of nearly 50 percent, NMFS initiated a status review of the CI beluga whale stock on November 19, 1998 (63 FR 64228). In the status review, NMFS evaluated the present status of CI beluga whales and made recommendations regarding a designation as depleted under the MMPA and listing as threatened or endangered under the ESA.

The comment period on the status review, which was initiated at the same time that workshops were convened to review beluga whale stocks throughout Alaska, extended from November 19, 1998, through January 19, 1999. The workshops were held by the Alaska Beluga Whale Committee (November 16-17, 1998) and the Alaska Scientific Review Group (November 18-20, 1998), a body established under the MMPA to provide scientific advice regarding marine mammals to NMFS and the U.S. Fish and Wildlife Service (FWS).

NMFS received two petitions in March 1999 to list CI beluga whales as endangered under the ESA. One petition requested an emergency listing under section 4(b)(7) of the ESA and the designation of critical habitat. Both petitions requested immediate promulgation of regulations to govern the subsistence harvest. NMFS determined that the petitions contained substantial scientific or commercial information indicating that the petitioned actions may be warranted (64 FR 17347, April 9, 1999).

To ensure that the status review was comprehensive and based on the best available scientific information, the comment period was followed by a NMFS-sponsored workshop on March 8-9, 1999, in Anchorage, Alaska, that reviewed relevant scientific information on this stock. At this workshop, NMFS received additional public comments and recommendations. The abstracts of presentations from this workshop are summarized in a NMFS report (NMFS, 1999) and are available to the public.

Following these reviews and taking into account the best information available at that time, NMFS proposed designating the CI stock of beluga whales as depleted on October 19, 1999 (64 FR 56298). NMFS also conducted a public hearing on November 22, 1999, on the proposed designation of the CI stock of beluga whales as depleted under the MMPA. NMFS issued a final rule on May 31, 2000, (65 FR 34590) designating CI beluga whales as depleted under the MMPA based on its determination that the stock is below its Optimum Sustainable Population (OSP) level.

NMFS had not made a final decision on the ESA petitions at the time of the depleted determination. The ESA petitions have now been reviewed in light of the best available scientific information. This review considered the significant legislative and management actions that have occurred since NMFS received the petitions.

Prior to the receipt of the petitions, NMFS, Alaska Region, Protected Resources Division, recommended to the Regional Administrator (in a memorandum dated February 23, 1999) that NMFS seek legislative action to prohibit the sale of CI beluga products under the subsistence provisions of the MMPA and/or impose a moratorium on the hunting of CI beluga whales in 1999. The recommendation included advice that NMFS designate the stock as depleted under the MMPA or list it as threatened or endangered under the ESA. These recommendations were based on the then unsustainable level of the subsistence harvest and the fact that no regulations were in place to restrict the harvest because the harvest was believed to be the most important factor linked to the decline of the stock. The MMPA and ESA provide a specific process for limiting Alaska Native subsistence harvest. This process begins with the designation of a stock as depleted under the MMPA or listing as threatened or endangered under the ESA.

Results of the 1998 surveys were not completed at the date of the Division's memorandum. Because the stock was declining and there was no immediate mechanism to limit the harvest, the Protected Resources Division recommended that NMFS consider a proposed listing under the ESA.

The following events had a significant bearing on NMFS' determination not to list CI beluga whales as endangered or threatened under the ESA:

(1) Congress passed legislation to prohibit the taking of CI beluga whales for Native subsistence use unless authorized by a cooperative agreement between NMFS and affected Alaska Native organizations (ANOs). On May 21, 1999, President Clinton signed the legislation into effect as Public Law 106-31. Pub. L. 106-31 established an enforceable mechanism to control the harvest, which was the only factor found to be directly linked to the decline. Prior to this law, the Federal government could not restrict the harvest, and a Native Alaskan could have harvested beluga whales from Cook Inlet without the approval of any local tribal authority of any local tribal authority or governing body The legislation remains in effect until October 1, 2000. As a result of this legislation, there was no harvest in 1999.

(2) NMFS completed analyses of the 1994-1998 survey data. The results of the abundance estimates from surveys conducted 1994-1998 were 653 (CV = 0.43) in June 1994, 491 (CV = 0.44) in July 1995, 594 (CV = 0.28) in June 1996, 440 (CV = 0.14) in June 1997, and 347 (CV = 0.29) in June 1998. Subsequent analyses indicated a 71-percent probability that a 40-percent decline in abundance occurred between June 1994 and June 1998 surveys. These data provided the necessary scientific support to designate the CI beluga whale stock as depleted under the MMPA. NMFS has determined that CI beluga whales are depleted and has started the process under the MMPA to regulate the harvest.

(3) NMFS completed the analyses of the 1999 abundance survey data. The population estimate for CI beluga whales in 1999, in which there was no subsistence harvest, was 357 whales. This estimate is consistent with the results of simulation modeling for the stock in which there was no harvest. Although preliminary, these results suggest that controlling the harvest may be an effective mechanism to promote recovery of the stock. Results after 3-5 years of controlling the harvest would provide more conclusive evidence of recovery.

(4) On December 10, 1999, NMFS conducted a scoping meeting as part of a process under the National Environmental Policy Act (NEPA) to consider the environmental impacts of a Federal program to promote recovery of this depleted stock. After the scoping meeting, NMFS assessed the potential impacts to CI beluga whales caused by human-related activities ongoing in Cook Inlet, including the subsistence harvest of CI beluga whales by Alaskan Natives. Because the CI beluga whale stock is depleted, NMFS believes that any federally approved harvest plan would constitute a major action subject to the requirements of NEPA and, therefore, could not be completed until an Environmental Impact Statement (EIS) has been prepared. NMFS is preparing an EIS that assesses the impacts of various anthropogenic activities on CI beluga whales and their habitat. The draft EIS includes a discussion of the cumulative impacts of these activities on CI beluga whales. Following the completion of the final EIS and the procedure under the MMPA to limit subsistence harvest, NMFS will publish a final rule to regulate the subsistence harvest.

NMFS must ensure that future harvests are sustainable and do not cause the further decline of the CI beluga whale stock. Pub. L. 106-31, limiting subsistence harvest to that occurring under a cooperative agreement between an affected ANO and NMFS, expires on October 1, 2000. Therefore, NMFS must have one or more mechanisms in place to regulate this take prior to the next harvest season. In the absence of any action by NMFS to regulate the harvest, the future of this harvest, and the CI stock of beluga whales, would be uncertain.

Endangered and Threatened Species : Section 3(6) of the ESA defines an endangered species as “ * * *any species which is in danger of extinction throughout all or a significant portion of its range * * *” Section 3(19) defines the term threatened species as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.

“Species” under the ESA : Section 3(15) of the ESA defines species broadly as “ * * *any subspecies of fish or wildlife or plants and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.”

Comment 1 : One of the commenters focused directly on the current size of the population and questioned whether any other marine mammal has a population estimate as low as that for CI beluga whales and is not listed as endangered under the ESA.

Response : No other population of marine mammals is as small as the CI beluga stock and is not listed under the ESA. Although NMFS is concerned with the low abundance of the stock, abundance alone does not necessarily mean that the stock is in danger of extinction.

Historical abundances of CI beluga have been reported from as few as 500 to as many as 2,000, and NMFS believes there may have been 1,000-1,300 whales in the early to mid-1980s. Thus, the stock would have been reduced to about 25 to 35 percent of its historical abundance. The population consequences of such a decline are much less substantial than those for other small populations, such as North Atlantic right whales, which were reduced to less than 10 percent of their historical abundance.

Population growth is not well documented for CI beluga; however, there is some evidence that reproduction in the stock has not been compromised. As discussed later in this document, the population consists of a large proportion of juvenile whales, and the age of sexual maturity has apparently decreased in recent years. These observations indicate that CI beluga whales have the reproductive capacity to sustain population growth. Furthermore, the 1999 abundance estimate suggests that the population may be increasing, rather than decreasing, as a result of controlling the harvest.

Comment 2 : The Marine Mammal Commission (Commission) noted that, under criteria developed by the International Union for the Conservation of Nature and Natural Resources (IUCN), CI beluga whales would be classified as “endangered” or “critically endangered”.

Response : The IUCN criteria are all based upon characteristics of the population and do not include a consideration of the adequacy of existing regulatory mechanisms as is required under the ESA. Under the IUCN criteria, CI beluga would qualify as “endangered” only if the decline were continuing. The major factor related to the decline of CI beluga whales has been stopped under Federal law and is not likely to revert to unsustainable levels in the near future.

Furthermore, under IUCN criteria, the stock would be classified as “vulnerable” if there were fewer than 1,000 whales. At 1,000 animals, the CI beluga stock would likely be within its OSP levels under the MMPA, perhaps at or near its carrying capacity. Thus, if the stock numbered 1,000 whales, NMFS would consider the stock as small, isolated, and healthy, but IUCN would characterize it as “ * * *facing a high risk of extinction in the wild in the medium-term future * * *”. Although the IUCN criteria are appropriate to identify species that may need conservation measures, they do not include the full range of factors that are included in the ESA; therefore, they are not appropriate for a determination of the status of a stock under the ESA.

Comment 3 : The Commission stated that NMFS should consider how listing criteria have been used in the past and noted that NMFS listed the Guadalupe fur seal population as threatened when that population numbered between 1,200 and 1,500 individuals and was producing about 200 pups annually.

Response : The ESA listing criteria have to be applied to each situation individually. For some factors, NMFS reached similar conclusions about the two populations: (1) In neither case was the habitat considered to be adversely modified or diminished; (2) both had been reduced by human exploitation; and (3) there were adequate regulatory mechanisms in both cases.

The Commission noted that the fur seal stock was more abundant than CI beluga whales when the fur seals were listed. However, the fur seal stock was reduced by commercial exploitation in the 1700s and 1800s from a historical abundance, estimated to be 30,000 individuals, to very low numbers. The population was only about 6 percent of its historical abundance when it was listed in 1985, and it had been growing slowly since it was re-discovered in 1954.

On the other hand, CI beluga are probably about 25 to 35 percent of their historical abundance (as noted above). The large proportion of young whales in the stock indicates that reproduction has not been compromised. The 1999 abundance estimate is preliminary evidence that the stock is increasing. Therefore, NMFS believes that CI beluga are less likely to go extinct or to become endangered than Guadalupe fur seals were when they were listed in 1985.

NMFS and FWS issued a joint policy for listing, delisting and reclassifying species under the ESA (61 FR 4722, February 7, 1996). The policy outlines three elements to be considered in deciding the status of a possible distinct population segment as endangered or threatened under the ESA: (1) Discreteness of the population segment in relation to the remainder of the species to which it belongs; (2) the significance of the population segment to the species to which it belongs; and (3) the population segment's conservation status in relation to ESA criteria for listing.

Under the first element, the petitioners argue that the CI beluga whale population is discrete because it is markedly separated from other populations of the same species.

NMFS Response : NMFS concurs with this statement. Of the five stocks of beluga whales in Alaska, the CI stock is considered to be the most isolated, based on the degree of genetic differentiation between the CI stock and the four other stocks (O'Corry-Crowe, et al., 1997). This study suggests that the Alaska peninsula may be an effective barrier to genetic exchange.

Under the second element, NMFS must determine whether the population segment persists in an ecological setting that is unique and whether the loss of the discrete population would result in a significant gap in the range of the species. The petitioners assert that CI beluga whales are in a unique ecological setting (Cook Inlet) and are the only population of beluga whales in Alaska that are completely subarctic (south of the Alaska peninsula). Furthermore, they stated that the loss of the stock would create a significant gap in the range of the species.

NMFS Response : NMFS concurs with this assessment. The CI beluga whales are the only population of beluga whales that inhabit the Gulf of Alaska, and the genetic data show little or no mixing with other population segments. Therefore, the loss of the CI population segment would result in the complete loss of the species in the Gulf of Alaska with little likelihood of immigration from other population segments into Cook Inlet.

Therefore, based on the best available scientific information available to NMFS, the only supportable conclusion that can be reached (as recommended by the petitioners) is that CI beluga whales are a “distinct population segment” and, therefore, a species under section 3(15) of the ESA.

Under the third element of the joint NMFS/FWS policy, if a population segment is discrete and significant, its evaluation for an endangered or threatened status will be primarily based on a review of the factors enumerated in ESA section 4(a) after taking into account conservation efforts implemented pursuant to section 4(b)(1)(A).

Regarding CI beluga whales, section 4(a) of the ESA states that the Secretary of Commerce (Secretary) shall, by regulation promulgated in accordance with subsection (b), determine whether any species is an endangered species or a threatened species because of any of the following factors:

(A) The present or threatened destruction, modification, or curtailment of its habitat or range;

(B) Overutilization for commercial, recreational, scientific, or educational purposes;

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

(E) Other natural or manmade factors affecting its continued existence.

Section 4(b)(1)(a) further states that the Secretary shall make determinations required by subsection (a)(1) solely on the basis of the best scientific and commercial data available to him after conducting a review of the status of the species and after taking into account those efforts, if any, being made by any State or foreign nation to protect such species, whether by predator control, protection of habitat and food supply, or other conservation practices within any area under its jurisdiction or the high seas. The “Recent Conservation Actions” section of this document discussed efforts to protect CI beluga whales. The following sections of this document discuss the status of CI beluga whales with respect to the five factors included in the ESA.

The petitioners state that the current distribution of the CI population of beluga whales is reduced from historic levels and that all current descriptions of the species' range are largely limited to Cook Inlet. They cite the summary of survey data by Rugh et al. (In press), which states that in recent years a reduction has occurred in incidental sightings in the Gulf of Alaska, and a reduction has occurred in sightings in lower Cook Inlet and offshore areas of upper Cook Inlet. From this they inferred that the range of the species has been curtailed.

NMFS Response : A significant part of the habitat for this species has been modified by municipal, industrial and recreational activities in Upper Cook Inlet. Each of these activities (discussed later in this document), either individually or cumulatively, are of concern to NMFS. However, the data do not support a conclusion that the range of CI beluga whales has been diminished by these activities.

Cook Inlet beluga whales occupy the same range that they have always occupied. The information by Rugh et al. (In press) indicates that the summer occurrence of CI beluga whales has shifted to the upper inlet in recent decades whereas, historically, they were also found in the lower inlet during mid- to late-summer. There are many alternative hypotheses for the underlying cause of the change in distribution. For example, the overall population reduction in recent decades may have resulted in CI beluga whales inhabiting only the preferred feeding areas within the range (i.e., the upper inlet). Therefore, the change in distribution does not necessarily reflect an adverse modification of the lower inlet. No indication exists that the range has been, or is threatened with being, modified or curtailed to an extent that appreciably diminishes the value of the habitat for both survival and recovery of the species.

The petitioners discussed overharvest of CI beluga whales under the section on overutilization for commercial purposes. Although they recognized that this criterion focuses on commercial use of a species, the petitioners stated that distinguishing between whales killed primarily for subsistence and whales killed as part of a subsistence hunt and sold commercially is impossible.

NMFS Response : NMFS agrees that both forms of mortality are relevant to this discussion. However, the subsistence provisions of the MMPA allow a limited sale of edible products from marine mammals to be sold in Alaska Native villages, which include Anchorage, or for Alaska Native consumption. Therefore, although overharvest is of serious concern, NMFS has included the response on the overharvest issue in the analysis of other natural or man-made factors that affect the stock.

NMFS recognizes that even the limited sale allowed under the subsistence provisions of the MMPA may provide an economic incentive for one or more Alaska Natives to supply beluga products within Anchorage. Such a sale may help meet the cultural demand for traditional foods among the 20,000 or more Alaska Natives that reside in Anchorage. A successful long-term conservation strategy must address the sale of edible beluga products in Anchorage.

Although there was a commercial or sport (recreational) harvest of beluga whales in CI prior to enactment of the MMPA, none has existed since 1972. The only taking of beluga whales in Cook Inlet for scientific purposes is non-lethal and has no more than a negligible impact on the stock. NMFS is not aware of any taking for educational purposes in recent years that may have had an effect on the stock. Therefore, this factor is not causing the stock to be in danger of extinction, nor is it likely to do so in the foreseeable future.

Disease : The petitioners discuss the susceptibility of beluga whales to disease and suggest that very little is known on this subject matter specific to CI beluga whales.

NMFS Response : NMFS concurs that very little is presently known about the effects of disease on CI beluga whales. However, a considerable amount of information exists on the occurrence of diseases in CI beluga whales, and other beluga whale populations, and the effects of these diseases on the species.

Bacterial infection of the respiratory tract is one of the most common diseases encountered in marine mammals. Bacterial pneumonia, either alone or in conjunction with parasitic infection, is a common cause of beach stranding and death (Howard et al., 1983). From 1983 to 1990, 33 percent of stranded beluga whales in the St. Lawrence estuary (n = 45 sampled) were affected by pneumonia (Martineau et al., 1994).

Populations of beluga whales in Alaska appear relatively free of ectoparasites (Klinkhart, 1966, Hazard, 1988). Endoparasitic infestations are more common in beluga whales. Several species of endoparasites have been identified in beluga whales including populations found in Alaska and Canada (Klinkhart, 1966). Necropsies conducted on CI beluga whales have found heavy infestations in some adult whales. Approximately 90 percent of CI whales examined have had kidney parasites. Although extensive damage has been associated with this infection, whether this results in functional damage to the kidney (Burek, 1999a) is unclear. Stomach parasites are also present in CI beluga whales. However, these infestations have not been considered extensive enough to have caused clinical problems.

Parasites and the potential for diseases occur in CI beluga whales. Despite the considerable pathology that has been done on this species, nothing indicates that the occurrence of parasites or disease has had a measurable impact on their survival and health. Therefore, the factor related to disease does not support listing this population as threatened or endangered under the ESA.

Natural Predation : Killer whales are the only non-human predator of beluga whales in Cook Inlet. The petitioners state that the potential for significant impacts on the CI beluga whale population by killer whales cannot be ruled out given recent changes in prey availability to killer whales throughout the Gulf of Alaska (referring to declines in pinniped populations in the Central and Western Gulf of Alaska since the mid 1970s). The petitioners suggest that even a small increase in predation could result in population decline or impede recovery.

NMFS Response : The number of killer whales visiting the upper inlet appears to be small. However, predation by killer whales on CI beluga whales was considered by some commenters to be a mortality factor that may have contributed to the CI beluga whale declines in recent years. NMFS has received reports of killer whales in Turnagain and Knik Arms, between Fire Island and Tyonek, and near the mouth of the Susitna River. Native hunters have recently reported killer whales along the tide rip that extends from Fire Island to Tyonek (Huntington, 1999) and in Kachemak Bay.

No quantitative data exist on the level of removals from this population due to killer whale predation or its impact; however, killer whale pods prey selectively on salmon or marine mammals, including beluga whales, in Cook Inlet. During a killer whale stranding in Turnagain Arm in August 1993, one observer reported that a killer whale regurgitated pieces of beluga flesh. A potential dietary shift may account for some of the more recent sightings of killer whales in Cook Inlet.

On the other hand, pods of killer whales also feed on salmon, a prey of beluga whales. Therefore, seeing killer whales near beluga whales in the inlet does not necessarily imply that they are searching for beluga whales.

Assessing the impact of predation by killer whales on CI beluga whales is difficult. Anecdotal reports often highlight the more sensational, mortalities on beluga whales due to killer whales, thereby overemphasizing their impact. Further, these reports are from the early 1980s when beluga whales were more abundant. Consequently, they are of minimal value in evaluating current impacts to the population of beluga whales in Cook Inlet.

The loss of a few beluga whales could impede recovery, as suggested by the petitioners. However, in order for killer whale predation to be a significant factor in the observed decline in the beluga population, total mortality due to predation would have to be near the level of recruitment in the population. The literature and stranding records indicate that natural mortality in the CI beluga whale population does not exceed levels considered normal for other small cetacean populations. Therefore, predation by killer whales is not likely having a significant impact on the recovery of the CI beluga whale population.

Disease and predation occur in the CI beluga population and may affect reproduction and survival. The best available information, however, indicates that these factors are not causing the stock to be threatened or endangered.

The most immediate concerns by the petitioners were (1) the level of mortality as a result of subsistence harvest, and (2) the inability of NMFS, at the time of the petition, to control this harvest. The petitioners stated that the MMPA is inadequate to protect CI beluga whales. They further stated that under the MMPA, NMFS can pursue a co-management agreements with the tribes in the Cook Inlet region. However, the petitioners note, such an agreement provides no additional legal authority to NMFS to prosecute violations of the MMPA. According to the petitioners, even with a co-management agreement in place, neither NMFS nor the affected ANO can enforce its recommendations if hunters choose not to comply. Therefore, the petitioners suggested, such an agreement would not regulate non-local hunters nor restrict the sale of muktuk (whale skin, with blubber attached, used for food) in Anchorage. The petitioners stated that a co-management agreement was unlikely to reduce the Native hunt to sustainable levels and concluded that listing the CI population under the ESA was necessary to ensure complete compliance with agreed upon harvest limits, improve the monitoring of the harvest, and eliminate the sale of muktuk.

NMFS Response : Management of the CI beluga whale stock could be achieved through voluntary and cooperative efforts within a traditional Native community or through a co-management agreement. Prior to Pub. L. 106-31, no area-wide tribal authorities applied to all the Native Alaskans residing in Anchorage or the harvesting of CI beluga whales. For this reason, NMFS believes that the petitioners were correct in stating that a co-management agreement, without an enforceable regulatory mechanism, would not have provided the level of authority necessary to restrict the harvest to sustainable levels. Therefore, NMFS believes that the recovery of this stock requires not only the authority of a co-management agreement but also a Federal authority to protect and conserve CI beluga whales.

NMFS disagrees with the petitioners' statement that only through listing the CI population of beluga whales under the ESA can NMFS ensure complete compliance with agreed upon harvest limits, improve the monitoring of the harvest, and eliminate the sale of muktuk. On May 31, 2000, NMFS designated this stock as depleted under the MMPA. The depletion finding is the first step in the MMPA process for regulating the harvest. Under this process, annual harvest levels could be agreed upon through a co-management agreement and enforced, if necessary, through Federal regulations and tribal ordinances.

The process for regulating subsistence take of species listed under the ESA essentially mirrors the process for regulating of depleted species under the MMPA. Therefore, listing the stock under the ESA would not provide a better mechanism than under the MMPA to ensure compliance with harvest limits.

The petitioners further stated that Congress intended protections under the ESA to be applied in conjunction with protections under the MMPA because a marine mammal found to be threatened or endangered under the ESA is automatically listed as depleted under the MMPA.

NMFS Response : NMFS agrees that threatened or endangered marine mammals are protected under both the MMPA and the ESA. The MMPA states that marine mammals that are listed as threatened or endangered under the ESA are considered depleted under the MMPA. The ESA does not include a provision that requires a depleted marine mammal stock to be listed as threatened or endangered.

On at least two previous occasions, NMFS has designated stocks of marine mammals as depleted because these stocks were below OSP, but determined that the stocks were not threatened or endangered. NMFS was petitioned in 1991 to designate the eastern spinner dolphin and the northern offshore stock of spotted dolphin in the eastern tropical Pacific Ocean as depleted under the MMPA and to list them as threatened under the ESA. On October 19, 1992, NMFS published a determination that listing the eastern spinner dolphin under the ESA was not warranted and, on August 26, 1993, published a final rule designating the eastern spinner dolphin as depleted under the MMPA. Following a review of new information on the offshore spotted dolphin stock structure, NMFS designated the northeastern stock of offshore spotted dolphins (a smaller component of the northern offshore aggregation) as depleted on November 1, 1993. On January 7, 1993, NMFS issued a finding that the listing of northern offshore spotted dolphins as a threatened species under the ESA was not warranted. In both cases existing regulatory mechanisms were found to be adequate to allow the stock to rebuild and, thus, to prevent the stock from becoming endangered or threatened.

The existing regulatory mechanism is adequate to control the harvest of CI beluga whales to sustainable levels. To continue an adequate regulatory mechanism to restrict the harvest beyond October 1, 2000, NMFS would have to promulgate such regulations, or Congress would have to extend the special legislation that currently restricts the harvest. As discussed in other sections of this document, no other factor has been identified as having a significant adverse effect on the stock. Also as noted in other sections of this document, existing regulatory mechanisms are believed adequate to address future economic development in the area. Therefore, NMFS believes that an inadequate regulatory mechanism has not caused the stock to become in danger of extinction, nor is it likely to do so in the foreseeable future.

Stochastic Events : The petitioners stated that the population was currently so small that stochastic (random) events may cause the stock to decline to extinction. Their example related to strandings. The Commission also noted that the population was small and recommended that NMFS include an analysis of whether a listing as endangered or threatened is warranted simply because of risks posed by stochastic events.

NMFS Response : The analysis of strandings is discussed in the next section of this document. Breiwick and DeMaster (1999) examined the effects of stochastic events on the population dynamics of small populations of whales that are subjected to subsistence harvest. They used an individual-based model with stochastic birth and death rates to model populations subjected to harvest. They varied underlying intrinsic rates of increase from 0.025 to 0.049 and reported no extinctions in populations with no environmental stochasticity, even when these populations were subjected to harvest rates of up to 5 percent. When maximum environmental stochasticity (20 percent reduction in survival every 10 years) and the lower level intrinsic rate of increase (0.025) were used, no populations went extinct although populations harvested at a 3 percent level declined during 75 to 100 years of simulation. The results of the simulations indicate that CI beluga whales are not in danger of extinction or likely to become endangered in the foreseeable future due to stochastic events.

Stranding Events : The petitioners asserted that the population was so small that it was vulnerable to all natural sources of mortality, such as disease, predation, and stranding. They further asserted that a large stranding could occur that would kill most or all of the remaining beluga whales.

NMFS Response : NMFS estimates that over 590 whales have stranded (both individually and as groups) in upper Cook Inlet since 1988. Mass stranding events have most commonly occurred along Turnagain Arm and have often coincided with extreme tidal fluctuations (“spring tides”) and involved both adult and juvenile beluga whales.

Beluga whale mortalities have been observed during these stranding events. A 1996 mass stranding of approximately 60 beluga whales in Turnagain Arm resulted in the death of four adult whales. Five deaths resulted from another stranding of approximately 75 whales in August of 1999.

Catastrophic mortality (the deaths of a large number, such as 50 or more whales) due to a mass stranding event was not considered in simulations of the CI beluga stock for purposes of the status review. Such mortality could significantly impede recovery if it occurred; however, such catastrophic mortality has never been reported. Although mass strandings have occurred, only 9 whales died from a total of 135 whales included in the two mass strandings in 1996 and 1999. Mass stranding events are not believed to be a factor that has caused, or had a significant role in, the decline of this stock to depleted levels. Therefore, strandings, either individual or mass, have not caused the stock to be in danger of extinction nor are they likely to do so in the foreseeable future.

Subsistence Harvest : The petitioners stated that overutilization of beluga whales was undisputedly occurring. They further stated that the 1994-1997 levels of harvest were unsustainable.

NMFS Response : NMFS agrees with these statements. The history of harvest estimates from the years 1987-1999 will be included in the draft EIS and varied between zero and about 20 whales per year. These estimates, however, are considered underestimates because Alaska Native hunters and others stated that many whales were not reported or that the struck-and-lost rate was too low.

NMFS estimated that the average annual harvest between 1995 and 1998 was 78 whales. While subjected to this level of harvest, the stock has declined at an average rate of 15 percent per year from 1994 to 1998.

NMFS has been working with the Cook Inlet Marine Mammal Council (CIMMC) to develop a co-management agreement to conserve CI beluga and co-manage subsistence use of them. CIMMC is an ANO that represents several Alaska Native tribal governments in the CI area. Because NMFS and CIMMC had not entered into a co-management agreement under Pub. L. 106-31, no harvest was conducted in 1999. NMFS and CIMMC have, however, negotiated an agreement that would allow the harvest of a single whale after July 1, 2000.

The harvest estimates from 1995-1997 and the abundance estimates from 1994-1998 clearly indicate that the harvest was unsustainable prior to restriction in 1999. Furthermore, the subsistence harvest can account for the decline of the stock during that interval. Therefore, NMFS agrees that a failure to restrict the subsistence harvest would likely cause CI beluga whales to become in danger of extinction in the foreseeable future.

The petitioners stated that a depleted finding would allow NMFS to initiate rulemaking to limit the subsistence harvest of CI beluga whales, but harvest restrictions would not adequately address the problems facing CI beluga whales.

NMFS Response : NMFS disagrees that limiting the subsistence harvest would not adequately address the problems facing beluga whales in Cook Inlet. The subsistence harvest of these whales accounts for the observed decline in the stock since 1994. As indicated in the following discussion of anthropogenic factors that may affect beluga habitat, no other activity has had a known significant adverse effect on the stock or would cause the CI beluga whales to become in danger of extinction or likely to become endangered in the foreseeable future.

Other Natural or Manmade Activities : The petitioners identified the following activities or sources of potential threat to the CI beluga stock: commercial fisheries interactions with beluga whales; oil spills; other pollutants, contaminants (toxins such as Polychlorinated Biphenyls (PCBs), pesticides, heavy metals, hydrocarbons); predation from killer whales; noise from oil and gas development with associated seismic activity, drilling and refineries, airplanes (Anchorage Airport) and vessels; prey availability; research; and vessel traffic including commercial (whale watching) boat traffic. The petitioners assert that potential impacts from these activities on CI beluga whales, their prey, and the marine environment may be direct (e.g., lower survival rates) or indirect (e.g., loss of access to habitat or food resources).

NMFS Response : NMFS recognizes that municipal, commercial, and industrial activities are of concern and may affect the water quality and substrate in the inlet. However, no indication exists that these activities have adversely impacted beluga whales, including a quantitative impact on the beluga whale population. The best available information (as discussed in the following sections) indicates that these activities, alone or cumulatively, have not caused the stock to be in danger of extinction and are not likely to do so in the foreseeable future.

Commercial Fishery Interactions with Beluga Whales : State and Federally permitted commercial fisheries for shellfish, groundfish, herring and salmon occur in the waters of Cook Inlet, and have varying likelihoods of interacting with beluga whales due to differences in gear type, timing, and location of the fisheries. Interactions include entanglements, injuries, or mortalities occurring incidental to fishing operations.

Reports of marine mammal injury or mortality incidental to commercial fishing operations are obtained from the existing literature, fisheries reporting programs, and observer programs. During 1990-93, certain fisheries were required to participate in a logbook reporting program, which provided information regarding fishing effort, interactions with marine mammals and the outcome (deterred, entangled, injured, killed) of the interactions. Data from this program were difficult to interpret (Young et al. 1993) and tended to underestimate actual incidental mortality rates (Credle et al., 1994).

The logbook program was replaced by the 1994 MMPA amendments with a fisher self-reporting program, in which all commercial fishers are required to notify NMFS of injuries or mortalities to marine mammals occurring during the course of commercial fishing. This program became effective in 1995 and is currently in operation. In general, however, fewer reports have been received under this program than expected, given the results of the previous logbook reporting program and results from observer programs. Thus, annual mortality rates derived from these programs should be considered minimum estimates (Hill and DeMaster, 1999).

A number of fisheries occurring in or near the inlet present little, if any, chance of catching beluga whales. These fisheries are classified in Category III under the MMPA (65 FR 2448, April 26, 2000) because NMFS has determined that there is only a remote likelihood that they would kill or seriously injure any marine mammal incidental to their operations. These fisheries were classified in Category III fisheries during the period 1990 through 1994 and were not required to participate in the logbook program. Since 1995, when the existing reporting system required the reporting of all injuries of marine mammals incidental to fishing operations, none of these fisheries have reported incidental mortality or injury of marine mammals. In addition, no interactions between beluga whales and northern Gulf of Alaska groundfish trawl, longline or pot fisheries were reported by federal observers during 1990-99 (Hill and DeMaster, 1999).

The largest fisheries, in terms of participant number and landed biomass in Cook Inlet, are the salmon drift and set gillnet fisheries concentrated in the central and northern districts of upper Cook Inlet, where beluga whales are most likely to be found in the spring and summer (Rugh et al., In press). Times of operation change depending upon management requirements. In general the drift gillnet fishery operates from late June through August, and the set gillnet fishery during June through September.

The only reports of beluga whale mortality caused incidental to commercial salmon gillnet fishing in Cook Inlet are found in the literature prior to the observer programs and reporting systems required by the MMPA. Murray and Fay (1979) stated that salmon gillnet fisheries in Cook Inlet caught five beluga whales in 1979. An incidental take rate by commercial salmon gillnet fisheries in the Inlet was estimated at three to six beluga whales per year during 1981-83 (Burns and Seaman, 1986). Neither report, however, differentiated between the set and drift gillnet fisheries.

There have been no recent reports of beluga whales in Cook Inlet being killed or injured incidental to commercial fishing operations. No reports of injuries or mortalities incidental to salmon drift or set gillnet fishing were reported during the 1990-91 logbook reporting program, and none have been included in the reporting system in place since 1995.

To address the heightened concern in Cook Inlet and verify the results from the self-reporting system, NMFS placed observers in the salmon drift gillnet fishery and the upper and lower inlet set gillnet fishery in 1999. Observers were deployed on the first drift gillnet opening of June 28. Limited set gillnet fisheries were operating in the upper Cook Inlet on June 7, but observers were not placed until June 27. Thus, fishing effort associated with approximately 239 of 11,300 deliveries was unobserved during this period. Observers were placed on drift vessels during each of the eight regular and nine corridor-only fishing periods, and during emergency order extended fishing periods.

In 141 net-days (in which a net is fished at least 6 hours in a 24-hour period) in the drift gillnet fishery, observations were made of 744 sets and/or hauls of 102 different vessels for a total of 845 hours observation time. In 256 net-days within the set gillnet fishery, 1,450 observations were made of soaks and/or hauls of 275 different vessels, totaling 1,545 hours of observation time.

Marine mammals were observed within 300 m of a net by observers 43 times (about 6 percent of the observations) for drift gillnet sets, and 107 times (about 7 percent of the observations) for set gillnet effort. Of these, only three sightings were of beluga whales, each from an observer at a set gillnet sight in upper Cook Inlet. The beluga whales were not observed within 10 m of any net (i.e., within a distance categorized as an “interaction”) in the drift (35 individual marine mammals observed) or set (78 individual marine mammals observed) gillnet fisheries. Three marine mammals were observed entangled in nets, none of which were beluga whales.

Personal-use gillnet fisheries also occur in Cook Inlet, and have been subjected to many changes since 1978 (Ruesch and Fox, 1999), as summarized in Brannian and Fox (1996). The most consistent personal-use fishery is the use of single 10-fathom gill nets for salmon in the Tyonek Subdistrict of the Northern District (Ruesch and Fox, 1999). Personal-use gill nets have also been allowed within waters approximately 1.5 miles (2.4 km) of the Kasilof River. In 1995, personal-use gill nets were allowed in most areas open to commercial salmon set gillnet fishing. Most of this area was closed to personal gill net use in 1996. Personal-use salmon set gillnet fisheries are also found in the Port Graham subdistrict of lower Cook Inlet. NMFS is unaware of any beluga whales injured or killed in the Cook Inlet personal use/subsistence gillnet fisheries.

In summary, beluga whales apparently were caught in fishing nets from 1979 to 1983. None have been included in fisher self-reports since the late 1980s. Furthermore, in the fisheries in which observers were placed since 1990 (including those for which mortality was reported in the early 1980s), no beluga whales have been observed entangled in nets or close enough to a net to be described as an interaction. NMFS considers that the set and drift gillnet fisheries may occasionally cause mortality and serious injury of marine mammals; however, there is a remote likelihood that other fisheries operating in CI will kill or seriously injure a marine mammal incidental to their operations. Because no CI beluga have been reported or observed to have been killed or seriously injured incidental to the gillnet fisheries, the working estimate for mortality incidental to fishing operations would be that no beluga have been killed in CI since 1990. None of the more than 590 beluga whales that have stranded in CI were entangled in fishing gear; therefore, the stranding data support the working estimate of no incidental mortality. Therefore, based upon the best available information, NMFS does not believe that mortality incidental to commercial fishing operations is having, or has had, a significant impact on the CI beluga whale stock.

Oil Spills : Oil production, refining, and shipping occur in Cook Inlet. Therefore, oil and other hazardous substances may be spilled and, thus, impact the CI beluga whale stock. The Outer Continental Shelf Environmental Assessment Program estimated that 21,000 barrels of oil were spilled in the Inlet between 1965 and 1975, and 10,000 barrels were spilled from 1976 to 1979 (MMS, 1996). In July, 1987, the tanker Glacier Bay struck an unchartered rock near Nikiski, Alaska, discharging an estimated 1,350 to 3,800 barrels of crude oil into the inlet (USCG, 1988). Beluga whales are commonly found in the area of this spill.

There are no data available that describe behavioral observations or deleterious effect of these spills on beluga whales nor that accurately predict the effects of an oil spill on beluga whales. Some generalizations, however, can be made regarding impacts of oil on individual whales based on present knowledge.

An oil spill could result in a beluga whale contacting or ingesting the oil or suffering respiratory distress from hydrocarbon vapors. The spill may also contaminate food sources or displace the whales from feeding areas. Whales could be affected through residual oil from a spill even if they were not present during the oil spill. The most likely effects of oil would be irritation of the respiratory membranes and absorption of hydrocarbons into the bloodstream (Geraci, 1990).

If an oil spill were concentrated in open water (e.g. within tide rips), a beluga whale might inhale enough vapors from a fresh spill to affect its health. No reliable data exist on the effects of petroleum vapor inhalation on cetaceans; however, inhalation of vapors in excess of 10,000 ppm is fatal to humans (Ainsworth, 1960; Wang and Irons, 1961). Inhalation of petroleum vapors can cause pneumonia in humans and animals due to large amounts of foreign material (vapors) entering the lungs (Lipscomb et al., 1994). Although pneumonia was not found in sea otters that died after the Exxon Valdez oil spill, inhalation of vapors was suspected to have caused interstitial pulmonary emphysema (accumulation of bubbles of air within connective tissues of the lungs). Crude oil evaporation rates are greatest during the first few days after an oil spill (Meilke, 1990).

Whales may also contact oil as they surface to breathe, but the effects of oil contacting skin are largely speculative. Experiments in which bottlenose dolphins were exposed to petroleum products showed transient damage to epidermal cells, and that cetacean skin presents a formidable barrier to the toxic effects of petroleum (Bratton et al., 1993). Geraci and St. Aubin's (1985) investigations found that exposure to petroleum did not make a cetacean vulnerable to disease by altering skin microflora or by removing inhibitory substances from the epidermis.

Geraci (1990) reviewed a number of studies pertaining to the physiologic and toxic impacts of oil on whales and concluded no evidence exists that oil contamination had been responsible for the death of a cetacean. Cetaceans observed during the Exxon Valdez oil spill in Prince William Sound made no effort to alter their behavior in the presence of oil (Harvey and Dahlheim, 1994; Loughlin, 1994).

Following the Exxon Valdez oil spill, daily vessel surveys of Prince William Sound were conducted from April 1 through April 9, 1989, to determine the abundance and behavior of cetaceans in response to the oil spill (Harvey and Dahlheim, 1994). During the nine surveys, 80 Dall's porpoise, 18 killer whales, and two harbor porpoise were observed. Oil was observed on only one individual, which had oil on the dorsal half of its body and appeared stressed due to its labored breathing pattern. A total of 37 cetaceans were found dead during and after the oil spill, but cause of death could not be linked to exposure to oil (Loughlin, 1994). Dalheim and Matkin (1994) reported 14 killer whales missing from a resident Prince William Sound pod over a period coincident with the Exxon Valdez oil spill. They noted that nearly all resident killer whales likely swam through heavily oiled sections of the sound and that the magnitude of that loss was unprecedented. Dalheim and Matkin concluded a correlation existed between the loss of these whales and the spill, but they could not identify a cause-and-effect relationship.

Toxicity of crude oil decreases with time as the lighter, more harmful, aromatic hydrocarbons, such as benzene, evaporate. Acute chemical toxicity (lethal effects) of the oil is greatest during the first month following a spill. Sublethal effects may be observed in surviving birds, mammals, and fish for years after the spill. Sublethal and chronic effects include reduced reproductive success, blood chemistry alteration, and weakened immunity to disease and infections (Spies et al., 1996).

Contaminated food sources and displacement from feeding areas may also occur as a result of an oil spill. Over a 3-month period, Caldwell and Caldwell (1982) fed 335 ml of hydraulic oil to bottlenose dolphins. The dolphins did not reject the fish containing oil capsules. They were necropsied after the experiment, and no lesions attributable to oil were detected.

These studies indicate that an oil spill could have an effect on beluga whales if one were to occur. However, no significant impact on beluga whales can be attributed to oil spills or production in CI despite high levels of oil production, refining, and transport within the inlet and its watershed. Therefore, at current levels of activity, oil and gas exploration and development are not expected to have a significant impact on the CI beluga stock.

The oil and gas industry has a history of compliance with the MMPA and ESA for their operations in Alaska, and the MMPA provides a regulatory regime to ensure that the taking of marine mammals incidental to commercial activity would have no more than a negligible impact on marine mammals. Furthermore, the MMPA provisions that establish this regime include a requirement that the activity must not have an unmitigable adverse impact on the availability of marine mammals for subsistence uses. Consequently, there is an adequate regulatory mechanism to address future expansion of the oil and gas industry in Cook Inlet.

Other Pollutants : The principle sources of pollution in the marine environment are (1) discharges from municipal waste-water treatment systems; (2) discharges from industrial activities that do not enter municipal treatment systems (petroleum and seafood processing); (3) runoff from urban, mining, and agricultural areas; and (4) accidental spills or discharges of petroleum and other products. Natural and man-made pollutants entering the inlet are diluted and dispersed by the currents associated with the tides, estuarine circulation, wind-driven waves and currents (MMS,1996).

Pollutants may be classified as chemical, physical, and biological. Chemical pollutants include organic and inorganic substances. The decomposition of organic substances uses oxygen and, if enough organic material is present, the concentration of oxygen could be reduced to levels that would threaten or harm oxygen-using inhabitants of the water column.

The discharge of soluble inorganic substances may change the pH or the concentration of trace metals in the water, and these changes may be toxic to some marine plants and animals. Physical pollutants include suspended solids, foam, and radioactive substances. Suspended solids may inhibit photosynthesis, decrease benthic activity, and interfere with fish respiration. Foam results from surface active agents and may cause a reduction in the rate of oxygen-gas transfer from the atmosphere into the water. Biological pollutants may promote waterborne disease by adding pathogens to the receiving waters or may stimulate excessive biological growth.

i. Produced Waters: Produced waters constitute the largest source of man-made substances discharged into the waters of Cook Inlet. The characteristics of the produced waters, as well as other discharges, except drilling muds and cuttings described in this section, are based on information obtained during the Cook Inlet Discharge Monitoring Study, conducted between April 10, 1988, and April 10, 1989 (EBASCO Environmental, 1990a; 1990b). These waters are part of the oil/gas/water mixture produced from the wells and contain a variety of dissolved substances. Also, chemicals are added to the fluids as part of various activities including water-flooding; well work-over, completion, and treatment; and the oil/water-separation process. Before being discharged into Cook Inlet, produced waters pass through separators to remove oil and gas. The treatment process removes suspended oil particles from the waters, but the effluent contains dissolved hydrocarbons or those held in colloidal suspension (Neff and Douglas, 1994). Although the discharge of produced waters is an issue of concern, the toxicity of produced waters, as indicated in the monitoring study, ranged from only slightly toxic to practically nontoxic (to shrimp) and would not, therefore, be expected to impact beluga whales.

ii. Drilling Muds and Cuttings: A general permit issued by the Environmental Protection Agency (EPA) authorizes the discharge of approved generic drilling muds and additives into waters of Cook Inlet. Drilling muds consist of water and a variety of additives; 75 to 85 percent of the volume of most drilling muds currently used in Cook Inlet is water (Neff, 1991).

When released into the water column, the drilling muds and cuttings discharges tend to separate into upper and lower plumes (Menzie, 1982). The upper plume contains the solids and water-soluble components that separate from the material of the lower plume and are kept in suspension by turbulence.

The discharge of drilling muds at surface ensures dispersion and limits the duration and amount of exposure to organisms (NRC, 1983). Most of the solids in the discharge, >90 percent, descend rapidly to the sea floor in the lower plume. The sea floor area in which the discharged materials are deposited depends on the water depth, currents, and material particle size and density (NRC, 1983). In most Outer Continental Shelf areas, the particles are deposited within 500 ft below the discharge site; however in Cook Inlet, which is considered to be a high-energy environment, the particles are deposited in an area that is >500 ft below the discharge site (NRC, 1983). Small particles of drilling mud (several centimeters in diameter) also may settle to the sea floor immediately following a discharge but would disperse within a day.

Since 1962, 546 wells have been drilled in Cook Inlet. One Continental Offshore Stratigraphic Test well and 11 exploration wells were drilled in Federal waters and 75 exploration and 459 development and service wells were drilled in State waters, mainly in upper Cook Inlet (State of Alaska, AOGCC, 1993). From 1962 through 1970, 292 wells were drilled, including 62 for exploration and 230 for development and service (State of Alaska, AOGCC, 1993). From 1971 through 1993, the number of wells drilled per year has ranged from 3 to 20, with an annual average of about 11.

The toxicity of the muds used to drill 39 production wells in Cook Inlet between August 1987 and February 1991 ranged from 1,955 to >1,000,000 ppm for a marine shrimp (Neff, 1991). Concentration levels >10,000 ppm are considered practically nontoxic and between 1,000 and 10,000 ppm are slightly toxic. The percentages of the wells with toxicities >10,000 ppm was 89 percent of the total number. Therefore, 89 percent of the muds from this production were considered non-toxic to shrimp. Given the results of this study, the toxicity levels of production muds do not likely impact beluga whales.

iii. Heavy Metals and Organic Compounds: NMFS has obtained biological samples from CI beluga whales under protocols developed for the Alaska Marine Mammal Tissue Archival Project. From these collections, selected tissues have been analyzed for PCBs and trace elements, including heavy metals in liver and kidneys. As has been found for beluga whales from other regions in Alaska, Canada, and Greenland, the CI beluga whales were found to have relatively high concentrations of mercury, selenium, and silver in their livers. These levels are much higher than one finds in ringed seals, harbor seals, bowhead whales, and walrus in Alaska. However, as compared to other Alaskan beluga whale stocks (Eastern Chukchi Sea and Eastern Beaufort Sea), the levels of these three metals, as well as cadmium, were much lower in the Cook Inlet animals (Becker et al., in press). These elements accumulate in liver tissue and increase with age of the animal. The uptake and bioaccumulation of these elements are determined by many factors, and the diet of the animal plays a major role (Becker et al., In press).

Concentrations of PCBs and chlorinated pesticides were found to be lower in the blubber of beluga whales from CI than from beluga whales from Point Lay (Eastern Chukchi Sea stock) and Point Hope (Eastern Beaufort Sea stock), Alaska. Generally, CI beluga whales are “cleaner” than other beluga whale populations throughout the Arctic and the eastern United States. A comparison of tissue concentrations of persistent organic contaminants, heavy metals, and other elements between CI beluga whales and other beluga whales in North America confirms that the CI animals are distinct from other populations and stocks of this species. The CI animals had much lower concentrations of PCBs and chlorinated pesticides than those which have been reported from the Eastern Beaufort Sea and Eastern Chukchi Sea stocks. Due to the lower concentrations of PCBs and chlorinated pesticides in CI beluga whales, their effects on the animals' health may be less significant for CI animals than for the other beluga whale stocks.

iv. Municipal Wastes and Urban Runoff: Ten communities currently discharge treated municipal wastes into Cook Inlet. Wastewater entering these plants may contain a variety of organic and inorganic pollutants, metals, nutrients, sediments, and bacteria and viruses. Of these, the Municipality of Anchorage's John M. Asplund Treatment Center, English Bay, Port Graham, Seldovia, and Tyonek use only primary treatment, and Eagle River, Girdwood, Homer, Kenai, and Palmer use secondary treatment. The maximum permitted wastewater discharge for Anchorage is 44 million gallons per day (GPD), and that for other communities ranges from 10 thousand to 1.6 million GPD. The EPA is currently in the process of re-issuing the Asplund facility discharge permit.

For Anchorage, the effluent limitations requested for the daily discharge of organic material, such as sewage (often reported as Biological Oxygen Demand (BOD)), and total suspended solids in the wastewater are 90,100 pounds per day (lb/d) and 57,000 lb/d, respectively. Based on the daily maximums presently permitted for these ten communities, they could release about 16.38 million pounds of BOD and 13.82 million pounds of suspended solids into CI annually.

Determining the impact of municipal discharges on the beluga whale stock is not possible. The rivers entering Knik Arm alone carry an estimated 20 million tons of sediment annually (Gatto, 1976). Therefore, the suspended loading that naturally occurs in the extreme upper inlet parallels that discharged by the Municipality of Anchorage. The impact of the sediment loading by discharges on beluga whales is not known. Given the relatively low levels of contaminants found in CI beluga whale tissues, municipal discharge levels are not believed to be having a significant impact on the beluga whale population.

Noise : Upper Cook Inlet is one of the most industrialized and urbanized regions of Alaska. As such, noise levels may be high. The petitioners recognized this as a factor that might cause beluga whales in Cook Inlet to avoid using parts of their available habitat due to noise levels. The common types of noises in upper Cook Inlet include sounds from vessels, aircraft, construction equipment (e.g., diesel generators, bulldozers, and compressors) and from activities such as pile-driving.

Any sound signal in the ocean is detectable by marine mammals only if the received level of the sound exceeds a certain detection threshold (Richardson et al., 1995). If the sound signal reaching a marine mammal is weaker than the background noise level, it may not be detected. This concept is important in understanding the effects of noise on whales in at least two areas: (1) The audibility of an industrial noise is dependent in part on the background (ambient) noise levels, and (2) as industrial noises add to the level of background noise, they may prevent or diminish the effectiveness of communication among whales or between whales and their environment.

Considering the depth of the animal being exposed to noise is also important. The noise level from a source when measured within 3 ft (1 m) of the surface is significantly lower than the noise level when measured at depths of 16 to 33 ft (5 to 10 m). For example, a marine mammal at the surface will experience a received-noise level approximately 30 dB less than the level for an animal at the same distance from the source, but at a depth of 33 ft (10 m).

A noise of sufficient intensity must also be in the range of frequencies that beluga whales can hear. Their peak hearing is within the range of about 10,000 to 90,000 Hz (Richardson et al., 1995). Noises outside, but near, this range can be heard but not as well as those within the range.

i. Aircraft Noise: Richardson et al., (1995) and Richardson and Malme (1993) provided summaries on aircraft sound in water. The surface area of sound transmission from air to water is described by a cone where the apex of the cone is the aircraft, and the cone has an aperture of 26 degrees. In general, underwater noise from aircraft is loudest directly beneath the aircraft and just below the water's surface, and sound levels from the same aircraft are much lower underwater than the sound levels in air. The duration of the noise is short because noise is generally reflected off the water surface at angles greater than 13 degrees from vertical. Helicopters tend to be noisier than fixed-wing aircraft. The amount of noise entering the water depends primarily on aircraft altitude, sea surface conditions, water depth, and bottom conditions (Richardson et al., 1995).

Monitoring results of aircraft noise levels are complicated due to variables that are inherent in such analyses, including monitoring equipment averaging times, aircraft types and operations (i.e., power setting, propeller pitch, altitude changes), meteorological conditions, and aircraft altitude. There are no data on the level of received sound that disturb or do not disturb toothed whales (Richardson et al., 1995). The response of beluga whales to airplanes and helicopters varies with social context, distance from the aircraft, and aircraft altitudes. Because the underwater noise generated by an aircraft is greatest within the 26 degree cone directly beneath the craft, whales often react to an aircraft as though startled, turning or diving abruptly when the aircraft is directly overhead. Richardson et al., (1995) reports beluga whales not reacting to aircraft flying at 500 m, but, when the aircraft was at lower altitudes (150-200 m) the whales dove for longer periods and sometimes swam away. Feeding beluga whales were less prone to disturbance. NMFS aerial surveys are normally flown at an altitude of 150 m, using fixed-wing single- and twin-engine aircrafts. Beluga whales are rarely observed to react to even repeated overflights at this altitude.

The main approaches to the Anchorage International Airport, Elmendorf Air Force Base, and Merrill Field are at least partially over the upper Inlet, including Knik Arm. Commercial and military jet airplanes often fly over these waters at relatively low altitudes. Despite this traffic, beluga whales are common to these same waters and are often observed directly under the approach corridors off the north end of International Airport and the west end of Elmendorf Air Force Base.

ii. Ship and Boat Noise: Ships and boats create high levels of noise both in frequency content and intensity level, and this noise can be detected at great distances. High-speed vessels tend to be much noisier than slow-speed vessels. Small commercial ships are generally diesel-driven, and the highest 1/3-octave band is in the 500 to 2,000 Hz range. Tugs can emit high levels of underwater noise at low frequencies. Small outboard motors, such as those commonly used for recreation in the upper Inlet, typically produce noise at much higher frequencies (e.g. 6300 Hz) and may have the highest potential to interfere with beluga whales.

iii. Noise from Offshore Drilling and Production: Sound produced by oil and gas drilling and production in Cook Inlet may be a significant component of the noise in the local marine environment. Gales (1982) summarized noise from eleven production platforms. The strongest tones from four production platforms were at very low frequencies (between 4 and 38 Hz).

Various studies and observations suggest that beluga whales are relatively unaffected by these activities. Belugas are regularly seen near drill sites in Cook Inlet (Richardson et al., 1995:282; McCarty 1981). Stewart et al., (1982) reported that beluga whales in Snake River, Alaska, did not appear to react strongly to play-backs of oil industry-related noise at levels up to 60 dB above ambient. Stewart, Awbrey, and Evans (1983) conducted similar playback experiments in Nushagak Bay, Alaska, in 1983 and found that beluga whale movement and general activity were not greatly affected, especially when the source of the noise was constant.

Beluga whales did swim faster and respiration rates sometimes increased within 1.5 km of the sound projector. During playback experiments in the Beaufort Sea, migrating beluga whales approached the sound projector and showed no overt reactions until within 200-400 meters, even though the noise was detectable by hydrophone up to 5km away (Richardson et al., 1990, 1991). Richardson et al. (1995) observed these results may be an example of the degree to which beluga whales can adapt to repeated or on-going man-made noise when it is not associated with perceived negative consequences.

iv. Noise from Seismic Geophysical Exploration: Geophysical exploration in CI for oil and gas deposits is often accomplished using boat-based seismic survey. Seismic surveys produce some of the loudest noises in the marine environment. These surveys use compressed air to generate short, intense bursts of underwater energy that may propagate for great distances. The noise produced by these surveys is at very low frequencies, often less than 100 Hz, which is below the optimum hearing range of beluga whales.

Higher frequencies are absorbed in water more than lower frequencies. Seismic sound propagation is also dependent on bottom structure, and soft substrates such as those found in the upper inlet absorb sound better than hard, reflective material. Finally, seismic sound is poorly transmitted through shallow waters, such as exists near the mouths of the Susitna River. Therefore, seismic exploration in the upper inlet may be poorly transmitted through the water and may have little direct impact on beluga whales. However, seismic sound may be very loud, with some sound energy at higher frequencies that overlap the peak auditory range of the beluga whale. Beluga whales would likely hear, and may react to, an active seismic vessel in certain areas and under certain conditions. Presently, no data exist to characterize the noise from seismic exploration in Cook Inlet. NMFS observed beluga whales in Cook Inlet approximately 20 nmi from an active seismic vessel in June 1995, and reported no reactions (Moore et al., In press).

v. Summary of the Impacts of Noise on CI Beluga Whales: Because sound is a critical sense to beluga whales, high levels of noise may have significant and adverse effects. However, evaluation and prediction of human-made noise impacts on marine mammals is difficult. Estimating acoustic environmental impact on animals requires interpretation and integration of results from many disciplines including, but not limited to, the study of how sound waves interact with the environment (physical acoustics), how animals hear sounds (anatomy and physiology), and how animals use sounds for behaviors such as communicating, navigating, and finding food (bio-acoustics and behavioral ecology).

One of the most obvious behavioral responses to industrial noise is to avoid the area by swimming away from or detouring around the noise source. Two other behavioral responses, habituation and sensitization, also are important when discussing the potential reactions of beluga whales to multiple exposures to a noise stimulus.

Habituation refers to the condition in which repeated experiences with a stimulus that has no important consequence for the animal leads to a gradual decrease in response. Richardson et al., (1995) provided examples of beluga whales becoming habituated to noise from frequent vessel traffic in the St. Lawrence River and to salmon fishing boats in Bristol Bay. Elsewhere, beluga whales have been observed to tolerate large vessel traffic (e.g., in the St. Lawrence River), and intensive commercial fishing vessel activity (in Bristol Bay). Beluga whales are commonly found immediately adjacent to the Port of Anchorage during summer months, often very near containerships and tugs which are docking, maneuvering, or underway.

Sensitization refers to the situation in which the animal shows an increased behavioral response over time to a stimulus associated with something that has an important consequence for the animal. Although whales tend to show little response to vessels that move slowly and are not heading toward them (Richardson et al., 1995), beluga whales will often leave an area in which vessel noise is related to hunting (Sergeant and Brodie 1975; Huntington, 1999). Native hunters in Cook Inlet have also reported that beluga whales actively avoid approaching skiffs powered by outboard motors, particularly during the summer and fall. Many researchers report that beluga whales commonly flee from fast and erratically moving small boats.

The variable response that beluga whales show to vessels indicates that these whales (1) are not disturbed by such activity, (2) habituate to such activity, (3) or (from Blane, 1990) continue to use some areas for feeding and traveling because these areas are critical to their survival. If the last alternative is actually the case, then the whales' lack of avoiding areas where vessel traffic routinely occurs should not be interpreted as the whales being undisturbed.

Beluga whales did not abandon an area within upper Cook Inlet even when they were being hunted and pursued (Shelden, 1995). A large group of beluga whales remained in or near the mouth of the Little Susitna River for several weeks during June of 1999. During this period, many small motor boats sport fishing for chinook salmon moved between Anchorage and the Little Susitna river.

CI beluga whales appear to display a strong fidelity to certain sites. They are similar in this respect to the Bristol Bay stock of beluga whales. It is generally believed in western and northern Alaska, however, that modernization of coastal communities, with its associated noise, is causing beluga whales to pass farther from shore and to abandon traditional sites (Burns and Seaman, 1986).

To what extent, if any, noise in the Cook Inlet area has had an effect on the current distribution or trends of these animals is not clear. Over the long-term, disturbance from noise, if it keeps belugas from foraging sites, could have an effect which would be expressed as a lower productivity rate due to low level, or chronic, stress symptoms that would inhibit successful foraging. However, no indication exists that this is happening. Given the fidelity of these whales to specific foraging sites in the upper inlet, the need to prey on available forage is apparently stronger than the impacts of potential disturbance from noise, or other factors, in those locations. Such site fidelity has also been witnessed in other whale populations.

Commercial Harvest : Klinkhart (1966) reported that a commercial harvest for beluga whales occurred in Cook Inlet in the 1930s. This harvest took about 100 beluga whales. These whales were netted in the Beluga River, and used for meat and oil. Guided sport hunting for CI beluga whales was also popular during the 1960s (Anchorage Daily Times, 1965); however, there is no information on the level of this harvest. These activities have not had an impact on CI beluga whales in recent decades.

Ship Strikes : The presence of beluga whales in and near river mouths entering upper Cook Inlet predisposes them to strikes by high speed watercraft associated with sport and commercial fishing and general recreation. The mouths of the Susitna and Little Susitna River in particular are areas where such vessel traffic and whales commonly occur. NMFS enforcement agents investigated a report of a jet skier approaching and striking belugas in Knik Arm in 1994. A stranded beluga whale examined in 1999 had an injury consistent with an old propeller injury (Burek, 1999b). Data are not available to quantify the impact of vessel strikes on the CI stock of beluga whales, but vessel strikes are not believed to have a significant impact on the population.

Tourism : Tourism is a growing component of the state and regional economies, and wildlife viewing is an important component of this activity. Many tour buses routinely stop at several wayside sites along Turnagain Arm in the summer, where beluga whales are often seen.

Presently no vessel-based commercial whale watching ventures operate in upper Cook Inlet. However, the popularity of whale watching and the close proximity of the activity, and beluga whales, to Anchorage suggests such operations may begin in the near future. Should whale watching operations develop in CI, NMFS plans to monitor them.

Prey Availability : Beluga whales actively feed in the upper inlet where prey species concentrate. The arrival of beluga whales into the northern Inlet coincides with the eulachon migration. Soon after the eulachon migration, salmon out-migrations and the first chinook salmon spawning runs begin.

NMFS biologists sampled stomachs from subsistence-harvested whales and found that many contain salmon and eulachon. Native hunters' observations indicate that the whales' distribution in Cook Inlet is dependent upon fish runs.

NMFS placed a radio transmitter on an adult beluga whale in 1999, and this animal remained in or near the mouth of the Little Susitna River for several weeks between May and June in 1999. This whale was observed swimming among a group of approximately 90 beluga whales. This group moved into the central region of the upper Inlet and into Knik Arm during the times coho salmon were returning to the Little Susitna River.

Several commenters stated their belief that fish runs have declined dramatically within Cook Inlet during the last decade, and that this decline has caused fewer beluga whales to visit the upper Inlet. Native observations (Huntington, 1999) also suggest that severe declines in fish runs have occurred in Cook Inlet during the past few years. Huntington reported that these changes resulted in a redistribution of the beluga whales and the subsequent decline of beluga whales in Cook Inlet. The available evidence, however, shows little trend in the size of fish runs and, in some cases, contradicts these observations.

Several waterways entering CI are monitored for anadromous fish migrations by the Alaska Department of Fish and Game (ADFG), and NMFS reviewed salmon escapement for selected species for three such index streams, the Yentna, Little Susitna, and Kenai Rivers (Fox and Shields, 2000).

Sockeye returns to the Yentna River fluctuate from 1981 through 1999, but no trend is apparent. The returns for 1997 through 1999 are above average for the entire period, but decline from a peak in 1997 to lower levels in 1998 and 1999.

Sockeye returns to the Kenai River are relatively consistent from 1978 through 1999, with the later years having slightly larger runs than early in the reporting period. Returns showed peaks in 1987 and 1989, which were much higher than any other year in the reporting period. The harvest of sockeye salmon in the last 10 years has exceeded the 44-year average harvest.

Coho returns to the Little Susitna River show an increasing trend from 1986 through 1991 and a decline from 1993 through 1999. The escapements in 1998 and 1999 were higher than in 1986 and 1987.

Other prey species may be important to CI beluga whale, but there are little quantitative data to evaluate stock abundance and trends. Herring occur in concentrations and are rich in lipids (high caloric value). During a study of salmon smolts within the upper Inlet, juvenile herring (ages 0 and 1) were the most consistently caught species, and were second in abundance of all species encountered (Moulton, 1994). Historically, the herring run along the western side of lower CI has supported a local commercial fishery for herring roe. In 1999, the roe fishery was closed due to declining herring biomass, which ADFG estimated as 6,000 to 13,000 tons (ADFG, 1999b).

Eulachon also migrate into rivers within CI. A commercial venture to harvest eulachon in the lower Susitna River operated in 1999. The fishery was limited to 50 tons (ADFG, 1999a) and achieved this level of harvest rapidly.

The available information does not provide a clear quantitative assessment on trends of fish stocks in CI. However, observations by NMFS scientists and Alaska Natives provide some indication of the abundance and availability of food to CI beluga whales. From records on stranded whales, NMFS scientists have noted a large proportion of gray (juvenile) beluga whales in the stock. Huntington (1999) reported that Alaska Native hunters and elders also stated that the majority of whales are gray and that CI beluga whales are becoming sexually mature when gray, which is not the normal pattern.

If the population were food-stressed, the expected population response would be for calf survival to be decreased and for the age of sexual maturity to be delayed. The higher proportion of juvenile whales and the decreased age of first reproduction, as indicated by the observation that gray beluga whales are producing calves, suggest that nutrition is not limiting the population.

The ESA instructs the Federal government to conduct a review of the status of the species and include efforts by any state or foreign nation to protect such species within any area under its jurisdiction or the high seas. NMFS conducted such a status review of CI beluga whales to determine whether the population should be listed as threatened or endangered under the ESA or designated as depleted under the MMPA.

NMFS conducted annual surveys of the Cook Inlet beluga whale between 1994 and 1998. The results show a sharp decline in estimated abundance, with the 1998 estimate (347 animals) nearly 50 percent lower than the 1994 estimate (653 animals).

The mean subsistence harvest level of CI beluga whales from 1995 through 1998 was 77 whales per year. There was no harvest in 1999, and NMFS is working with CIMMC to authorize the harvest of one whale in 2000. The harvest, which has been identified as the only factor that can account for the observed decline of the CI beluga stock, is being controlled through Pub. L. 106-31 and will be controlled through regulatory mechanisms that are available under the MMPA. The Pub. L. 106-31 will expire on October 1, 2000, and the protection will stop unless the legislation is extended or NMFS issues regulations that provide a long-term limitation on the harvest to promote recovery of the stock.

In simulation modeling efforts, NMFS scientists have demonstrated that the stock is not likely to continue to decline if the harvest is controlled. Breiwick and DeMaster (1999) showed that a stock with at least 300 individuals and a positive intrinsic growth rate, like that of beluga whales, would not go extinct due to stochastic events.

Using a logistic model with productivity values taken from the current CI beluga stock assessment report and an assumed carrying capacity of 1,300 whales, NMFS compared the rates of population growth using no harvest and a harvest of 2 whales per year. The no-harvest model indicated that the stock would be expected to double in about 2 decades. The latter model predicted that the harvest of 2 whales per year would have a negligible impact on the stock (i.e., such a harvest regime would not cause a significant delay in recovery compared to the no-harvest model).

The habitat of the stock has not been, nor is it likely to be, destroyed, modified or curtailed in sufficient extent to cause the stock to be in danger of extinction. The stock has not been overutilized for commercial, recreational, scientific or educational purposes. The effects of disease or predation are not well documented but are believed to be minimal. There is an adequate regulatory mechanism to control the subsistence harvest, which is the only factor that can account for the observed decline, through October 1, 2000. In addition, the MMPA provides an adequate mechanism to ensure that future commercial activity in CI would have no more than a negligible impact on the stock. Other natural or manmade factors (subsistence harvest) have affected the stock's continued existence; however, the current (since 1999) level of harvest would not have a significant adverse impact on the continued existence of CI beluga whales.

Based on the best available scientific information, NMFS has determined that the CI beluga whale population has declined to a level that is considered depleted under the MMPA. However, after taking into account the information summarized above, NMFS has determined that the stock is not in danger of extinction nor is it likely to become so in the foreseeable future. Therefore, NMFS has determined that listing CI beluga whales under the ESA is not warranted at this time.

NMFS remains concerned about the status of the CI beluga population and will continue to include the population on the list of candidate species under the ESA. Furthermore, NMFS will continue to monitor the abundance and population trend of the stock and will re-evaluate its status as needed.

A complete list of all cited references is available upon request (see FOR FURTHER INFORMATION CONTACT ).

The 1982 amendments to the ESA, in section 4(b)(1)(A), restrict the information that may be considered when assessing species for listing. Based on this limitation of criteria for a listing decision and the opinion in Pacific Legal Foundation v. Andrus , 675 F. 2d 825 (6 th Cir. 1981), NMFS has concluded that ESA listing actions are not subject to the environmental assessment requirements of NEPA. See NOAA Administrative Order 216-6.

As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process. In addition, this final action is exempt from review under Executive Order 12866.

In keeping with the intent of the Administration and Congress to provide continuing and meaningful dialogue on issues of mutual State and Federal interest, NMFS has conferred with State and local government agencies in the course of assessing the status of CI beluga whales. State and local governments have expressed support for the conservation of this stock of beluga whales. Dialogue with State and local agencies included an exchange and discussion of scientific information regarding beluga whales, factors that may be affecting them, and their status under the ESA and MMPA.

E.O. 13084 requires that if NMFS issues a regulation that significantly or uniquely affects the communities of Indian tribal governments and imposes substantial direct compliance costs on those communities, NMFS must consult with those governments, or the Federal government must provide the funds necessary to pay the direct compliance costs incurred by the tribal governments. This action does not impose substantial direct compliance costs on the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of E.O. 13084 do not apply to this action.

Nonetheless, NMFS took several steps to inform affected tribal governments and solicit their input during development of this determination and addressed their input within announcement of the determination. One tribal government and CIMMC, an ANO representing several tribes within Cook Inlet, formally commented on the status review. NMFS discussed the status of the CI beluga whale stock with CIMMC and other tribally-authorized ANOs prior to and during the status review and plans to continue working with local tribally-authorized ANOs to develop and implement an effective program to control the harvest of CI beluga whales and promote recovery of the stock.