On Februry 4, 2000, the Board published a new part 1208 of its regulations in title 5, Code of Federal Regulations (CFR), as an interim rule with request for comments (65 FR 5409). The new part describes the Board's practices and procedures with respect to appeals filed under the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), Public Law 103-353, as amended, and the Veterans Employment Opportunities Act of 1998 (VEOA), Public Law 105-339. The Board allowed 60 days, until April 4, 2000, for receipt of public comments. The Board received comments from the Department of Labor, Office of the Assistant Secretary for Veterans' Employment and Training (DOL/VETS), and from one local of a national employee organization representing postal workers (union local).

In addition to suggesting certain changes in the regulatory language, DOL/VETS asked that certain statements in the preamble to the interim rule be clarified. TheSUMMARYsection of the interim rule included a statement that a USERRA appellant may appeal to the Board “if a Federal agency employer or the Office of Personnel Management fails or refuses to provide an employment or reemployment right or benefit to which the person is entitledafter service in a uniformed service” (emphasis added). DOL/VETS noted that certain provisions of USERRA also protect persons who apply for service, have an obligation to perform service, or assist in an investigation, regardless of whether the person has actually performed service in a uniformed service. In response to the DOL/VETS suggestion, the comparable statement in theSUMMARYsection of this final rule refers to “an employment or reemployment right or benefit to which the person is entitledunder the Act” (emphasis added).

The first paragraph of theSUPPLEMENTARY INFORMATIONsection of the interim rule stated that USERRA and VEOA extended the Board's jurisdiction to include “complaints filed by covered persons,principally veterans,under each of these laws” (emphasis added). DOL/VETS pointed out that the majority of USERRA cases opened by that office in the past several years have been filed by current members of the National Guard and Reserve, rather than by veterans. Without deciding who are the principal filers under USERRA, the Board agrees that the restrictive language referring to veterans could have been confusing to members of the National Guard and Reserve and was unnecessary. As noted in theSUMMARY, the Board's VEOA jurisdiction, however, is limited to complaints filed by persons entitled to veterans' preference.

Under the heading, “Termination of Proceeding,” in theSupplementary Information; section of the interim rule, the Board distinguished USERRA from VEOA by pointing out that USERRA does not provide for termination of a Board proceeding before it has concluded with the issuance of a decision. VEOA does provide for such termination, if the Board has not issued a judicially reviewable decision within 120 days after the appeal was filed, where the appellant elects to file a civil action in an appropriate United States district court. DOL/VETS suggested that the statement about USERRA, in order to make the distinction between the two laws clearer, should have said that USERRA does not permit a person to terminate a Board proceeding and file a civil action in an appropriate United States district court before the Board proceeding has concluded with the issuance of a decision. Although the Board believes the original statement was clear, it notes that with the additional phrase suggested by DOL/VETS, the statement is more specific.

With respect to the regulatory language of the interim rule, DOL/VETS asked that sections 1208.11(b) and (c), 1208.12, 1208.13(a)(4), 1208.22(a) and (b), and 1208.23(a)(5)(i) each be amended to replace the words, “the Secretary has been unable to resolve the complaint,” with “the Secretary's efforts have not resolved the complaint.” DOL/VETS stated that the use of the word “unable” suggests that the Secretary attempts to resolve all complaints filed with DOL. According to DOL/VETS, if the Secretary does not believe that the action alleged in a USERRA or VEOA complaint occurred, the Secretary will not attempt to resolve the complaint. Instead, the Secretary will notify the claimant of the results of the investigation and advise him that thecase is being closed, at which point he may file an appeal with MSPB. The Board agrees that the change suggested by DOL/VETS should be made and amends each of the sections referenced above in this final rule.

DOL/VETS also suggested that section 1208.26(a) be expanded to clarify how the Board will interpret the VEOA provision regarding appeals to the Board under any other law, rule, or regulation in lieu of administrative redress under VEOA (5 U.S.C. 3330a(e)), including an example of how the provision would operate where an appellant makes claims covered by both USERRA and VEOA. The Board recognizes that this VEOA provision raises several questions of interpretation. Until such time as the Board and its reviewing court can interpret the provision through decisions in actual cases, however, the Board believes that it is best simply to restate the statutory provision in its regulation implementing the provision. Accordingly, the Board has not adopted this suggestion of DOL/VETS in the final rule.

The union local suggested that section 1208.13(a)(3), which requires a USERRA appellant to identify the provision of chapter 43 of title 38, United States Code, that was allegedly violated, be amended so that submission of this information would be permissive rather than mandatory. The local argued that requiring an appellant to identify the statutory provision that was allegedly violated “is burdensome on pro se litigants.” The local also cited to the Federal Circuit ruling inYatesv.MSPB,145 F.3d 1480, 1485 (Fed. Cir. 1998) and to Board rulings, relying onYates,inMartirv.Department of the Navy,81M.S.P.R. 421 (1999) andJohnsonv.United States Postal Service,85 M.S.P.R. 1 (1999). The essence of these rulings is that to invoke the Board's jurisdiction under USERRA, an appellant need not specifically cite USERRA. It is sufficient, for example, for an appellant to show that he performed service in a uniformed service, that he was denied a right or benefit guaranteed by chapter 43 of title 38, and that the right or benefit was denied because of his uniformed service.

The intent of section 1208.13(a)(3) was to assist an appellant in establishing Board jurisdiction over his USERRA appeal. The only basis for the Board's jurisdiction over such an appeal is a failure or refusal by a Federal agency employer or the Office of Personnel Management to provide a right or benefit guaranteed by chapter 43 of title 38 (other than a provision relating to benefits under the Thrift Savings Plan for Federal employees). In order to determine whether it has jurisdiction over a particular USERRA appeal, the Board must know what right or benefit guaranteed by chapter 43 of title 38 the appellant alleges an agency failed or refused to provide. To the extent that the interim rule requires that a USERRA appellant provide a statutory citation to the provision(s) allegedly violated or that USERRA be cited by name to invoke the Board's jurisdiction, however, it is inconsistent with the cases cited above. The Board, therefore, is amending § 1208.13(a)(3) in this final rule to require a USERRA appellant to describe in detail the basis for the appeal, that is, the protected right or benefit that was allegedly denied, including reference to the provision(s) of chapter 43 of title 38 allegedly violated if possible.

The Board is making one other change to the interim rule with respect to a matter not addressed in the public comments. Section 1208.14, Representation by Special Counsel, permits satisfaction of the Board's requirements for designation of a representative by submitting a copy of a USERRA appellant's written request to the Secretary of Labor that the complaint be referred to the Special Counsel for litigation before the Board. Because the Special Counsel can decline to represent a USERRA appellant before the Board, however, the appellant's written request to the Secretary, standing alone, is not sufficient to show that the Special Counsel has agreed to represent the appellant. Therefore, the Board is amending § 1208.14 to require submission of a written statement (in any format) that the appellant submitted a written request to the Secretary of Labor that the appellant's complaint be referred to the Special Counsel for litigation before the Board and that the Special Counsel has agreed to represent the appellant. Such statement will satisfy the Board's designation of representative requirements at 5 CFR 1201.31(a).

The Board is publishing this rule as a final rule pursuant to 5 U.S.C. 1204(h), 5 U.S.C.3330a, 5 U.S.C. 3330b, and 38 U.S.C. 4331.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 85-07-09, amendment 39-5033 (50 FR 13548, April 5, 1985), which is applicable to certain Airbus IndustrieModel A300 B2 and B4 series airplanes, was published in theFederal Registeron June 1, 2000 (65 FR 34993). The action proposed to continue to require inspection of the fuselage longitudinal lap joints and circumferential joints, and of the stringers and doublers for bonding delamination and cracks; and repairs, as necessary. The action also proposed to require expansions of certain inspection areas; revisions of certain inspection thresholds or intervals; changes in references to inspection; and the addition of a modification to certain longitudinal lap joints.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 20 airplanes of U.S. registry that will be affected by thisAD.

The inspection of the bonded longitudinal lap joints and circumferential joints to detect bonding delamination that is currently required by AD 85-07-09, and retained in this AD, takes approximately 146 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this currently required action on U.S. operators is estimated to be $175,200, or $8,760 per airplane, per inspection cycle.

The inspection of the bonded longitudinal lap joints and circumferential joints to detect corrosion and cracking that is currently required by AD 85-07-09, and retained in this AD, takes approximately 72 work hours per airplane to accomplish. Based on these figures, the cost impact of this currently required action on U.S. operators is estimated to be $86,400, or $4,320 per airplane, per inspection cycle.

The inspections of the bonded stringers and doublers to detect debonding that are currently required by AD 85-07-09, and retained in this AD, take approximately 129 work hours per airplane to accomplish. Based on these figures, the cost impact of these currently required actions on U.S. operators is estimated to be $154,800, or $7,740 per airplane, per inspection cycle.

The modification of the bonded longitudinal lap joint required by this AD will take as much as 581 work hours (not including access and close) per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts will cost as much as $16,148 per airplane, depending on kits purchased. Based on these figures, the cost impact of the required modification on U.S. operators is estimated to be as high as $1,020,160, or $51,008 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 96-20-10, amendment 39-9776 (61 FR 53044, October 10, 1996), which is applicable to certain Lockheed Model L-1011-385 series airplanes, was published in theFederal Registeron October 6, 1999 (64 FR 54230). The action proposed to supersede AD 96-20-10 to continue to require repetitive inspections to detect cracking of the canted pressure bulkhead at FS 1212, and repetitive inspections to detect cracking of the web at the fastener rows of the vertical stiffener-to-web; and repair or replacement of the web with a new web, if necessary. The action also proposed to require that the initial inspections be accomplished at a reduced threshold.

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

The commenter requests that the FAA revise paragraphs (b)(1)(i) and (b)(1)(ii) of the proposal to reference section 53-11-00, Figure 854, of the L-1011 Structural Repair Manual (SRM), dated March 15, 1999. Lockheed Repair Drawing LCC-7622-385 is referenced in the proposal as the appropriate source of service information for identifying areas in which cracking may be found. The commenter indicates that the drawing has been revised and incorporated into the SRM since the release of Lockheed Service Bulletin 093-53-277, Revision 1, dated November 19, 1998. The commenter states that confusion could arise due to the nature of certain LCC drawings that are not formally controlled or released; operators could have the outdated version of the drawing on file. The revised LCC drawing and new SRM figure provide more detail of the inspection area and more detail of the repair instructions on the bulkhead than those specified in the original version of the drawing.

The FAA concurs with the commenter's request to reference the revised service information, and has revised the final rule accordingly. However, the FAA finds that both repair drawings adequately identify the areas in which cracking may be found.

Therefore, the FAA has added a note to the final rule to give operators credit for using the version of the repair drawing cited in the proposal.

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

There are approximately 235 airplanes of the affected design in the worldwide fleet. The FAA estimates that 116 airplanes of U.S. registry will be affected by this AD. The requirements of this AD will not add any new additional economic burden on affected operators other than the costs that are associated with beginning the inspection at an earlier time than would have been required by AD 96-20-10 (initial inspection is now required within 18,000 flight cycles, rather than 20,000 flight cycles).

The actions that are currently required by AD 96-20-10, and are retained in this AD, take approximately 5 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $34,800, or $300 per airplane, per inspection cycle.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

The 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 underExecutive Order 13132.

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 97-13-06, amendment 39-10052 (62 FR 33545, June 20 1997), which is applicable to certain Saab Model SAAB 340B and SAAB 2000 series airplanes, was published as a supplemental notice of proposed rulemaking (NPRM) in theFederal Registeron June 13, 2000 (65 FR 37087). The action proposed to continue to require various inspections of fluorescent lamps and lampholders in the cabin area for discrepancies; corrections, if necessary; and reinspection of the lamps to ensure correct installation after replacement or reinstallation of the lamps or lampholders. The action also proposed to require replacement of the electronic light ballasts with improved ballasts, which terminates the reinspections, and to expand the applicability of the existing AD.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 78 airplanes of U.S. registry that will be affected by this AD.

The actions that are currently required by AD 97-13-06 take approximately 7 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $420 per airplane.

The new actions that are required in this AD will take as much as 9 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts will be provided free of charge by the manufacturer. Based on these figures, the cost impact of the new requirements of this AD on U.S. operators is estimated to be as much as $42,120, or $540 per airplane.

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

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

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

On May 26, 2000, the FAA issued Emergency AD 2000-11-52, for Sikorsky Model S-76 series helicopters, which requires determining the S/N of each main rotor blade and removing certain serial numbered main rotor blades. The AD also requires visually inspecting and replacing, if necessary, other certain serial numbered main rotor blades. That action was prompted by a report of a 20-inch crack in the root end pocket of a main rotor blade and three reports of root end pocket separation of 4 to 6 foot sections of main rotor blades during flight. The crack and the main rotor blade root end pocket separation were due to improper manufacture of certain main rotor blade skins. This condition, if not corrected, could result in a root end pocket separating and impacting a main rotor or tail rotor blade andsubsequent loss of control of the helicopter.

The FAA has reviewed Sikorsky Aircraft Corporation Alert Service Bulletin No. 76-65-50, dated May 25, 2000 (ASB), which identifies certain serial-numbered main rotor blades that need to be removed from service. The ASB also describes performing a visual inspection, implementing a recurring visual inspection of certain serial-numbered main rotor blades for span-wise skin cracks, and removing any main rotor blade with a span-wise crack from service before further flight.

Since the unsafe condition described is likely to exist or develop on other Sikorsky Model S-76 series helicopters of the same type design, the FAA issued Emergency AD 2000-11-52 to prevent main rotor blade root end pocket separation, impact with main rotor or tail rotor blades, and subsequent loss of control of the helicopter. The AD requires, before further flight, determining the S/N of each main rotor blade and accomplishing the following actions in accordance with the ASB described previously:

• Remove any main rotor blade identified by S/N in Group 1 of the ASB Planning Information before further flight.

• Before each flight and at intervals not to exceed 3 hours time-in-service, visually inspect any main rotor blade identified by S/N in Group 2 of the ASB Planning Information for a span-wise crack in the upper and lower root end area. Remove any main rotor blade with a span-wise crack and replace it with an airworthy blade before further flight.

Any blade repaired in accordance with Sikorsky Aircraft Corporation Overhaul and Repair Instructions (ORI) No. 76150-023, Revision A, dated May 26, 2000, is not affected by the requirements of this AD. Accomplishing ORI 76150-023, Revision A, dated May 26, 2000, on each affected blade is terminating action for the requirements of this AD. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the structural integrity of the helicopter. Therefore, the actions listed previously are required before further flight, and this AD must be issued immediately.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual letters issued on May 26, 2000, to all known U.S. owners and operators of Sikorsky Model S-76 series helicopters. These conditions still exist, and the AD is hereby published in theFederal Registeras an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

The FAA estimates that 167 helicopters of U.S. registry will be affected by this AD. It will take approximately 10 work hours to replace each main rotor blade, if necessary, and 4 work hours per helicopter to inspect the main rotor blades. The average labor rate is $60 per work hour. Required parts will cost approximately $99,651 per helicopter (assuming replacement of all 4 blades). Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $4,248,480 ($40,080 to inspect the fleet and $4,208,400 to replace all main rotor blades on 25 percent of the U.S. fleet).

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

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, 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 AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2000-SW-26-AD.” The postcard will be date stamped and returned to the commenter.

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD for BHTC Model 430 helicopters was published in theFederal Registeron May 3, 2000 (65 FR 25694). That action proposed to require replacing screws in the yaw, roll, pitch, and collective syncro resolvers, and installing a guard bracket on the yaw, roll, pitch, and collective syncro resolvers.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 33 helicopters of U.S. registry will be affected by this AD, that it will take approximately 6 work hours per helicopter to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will cost approximately $548. Based on these figures, the total cost impact of this AD on U.S. operators is estimated to be $29,964.

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

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

Under sections 361 and 369 of the PHS Act, as amended, the Secretary issues and enforces regulations necessary to prevent the introduction, transmission, or spread of communicable diseases in the United States. FDA and CDC have been delegated regulatory responsibility under these provisions. The regulations contained in part 1240 (21 CFR part 1240), pertain to interstate control of communicable diseases and are currently administered by FDA. Regulations to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States are currently administered by CDC in 42 CFR part 71. The Secretary is taking this action to consolidate regulations designed to control the spread of communicable diseases, thereby increasing the agencies' efficiency and effectiveness.

The Secretary is transferring regulatory authority contained in the following sections of 21 CFR part 1240 to CDC: Section 1240.3 introductory text and paragraphs (b), (c), (e), (g), (h), (l), (n), and (p); § 1240.30; and Subpart C—Restrictions on Travel of Persons (consisting of §§ 1240.40, 1240.45, 1240.50, 1240.54, 1240.55, and 1240.57). The transferred regulations will be sequentially renumbered in 42 CFR part 70. In addition, “Director of the Centers for Disease Control and Prevention”has been inserted in new 42 CFR 70.2 in place of “Commissioner of Food and Drugs,” currently in 21 CFR 1240.30.

Although regulatory authority with respect to interstate quarantine over persons in §§ 1240.3, 1240.30, and 1240.45 is being transferred to CDC, FDA is retaining its regulatory authority in §§ 1240.3, 1240.30, and 1240.45 with respect to animals and other products that may transmit or spread communicable diseases, to ensure that FDA's Center for Food Safety and Applied Nutrition has the necessary authorities to prevent the spread of disease from any conveyance engaged in interstate travel or in the event of inadequate local control. Current § 1240.45 is also being moved to 21 CFR part 1240, subpart B (Administrative Procedures), and subpart C is being removed and reserved. The Secretary is issuing this rule without publishing a general notice of proposed rulemaking because such a notice is not required for this rule of agency organization, procedure, or practice under 5 U.S.C. 553(b)(A).

Table 1 reflects the actions the Secretary is taking:

This transfer of authority does not affect other authority exercised by FDA under sections 361 and 369, or any other sections, of the PHS Act.

FDA has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. In the absence of an applicable categorical exclusion, CDC conducted an environmental assessment of this transfer of authority in accordance with the Department of Health and Human Services administrative guidance and determined that the transfer presented no significant impact on the human environment.

Executive Order 13132 applies when agencies formulate or implement policies or regulations that preempt State law or that have federalism implications. Executive Order 13132 provides that agencies are to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and assess carefully the need for such actions. FDA and CDC have examined this rule and have determined that it does not preempt State law and it does 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. Rather, the Secretary is taking this action to consolidate regulations to control the spread of communicable diseases, thereby increasing the agencies' efficiency and effectiveness. Therefore, no further action is required by Executive Order 13132.

FDA and CDC have examined the impacts of this rule under Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million or more, or adversely affecting in a material way a sector of the economy, competition, or jobs, or if it raises novel legal or policy issues. The agencies find that this final rule, which transfers existing regulatory authority from one agency to the other, is not a significant rule as defined by Executive Order 12866. No analysis is required under the Regulatory Flexibility Act (5 U.S.C. 601-612) because the Secretary is issuing it without publishing a general notice of proposed rulemaking, as explained previously in this document.

This final rule contains information collection provisions that are subject toreview by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In theFederal Registerof April 12, 2000 (65 FR 19772), CDC published a document entitled “Proposed Data Collections Submitted for Public Comment and Recommendations” to collect information under those regulations, and sought public comment for 60 days. The comment period closed on June 12, 2000. CDC will now prepare an information collection request for submission to OMB, and will publish another document in theFederal Registerannouncing submission of the request to OMB and soliciting that comments be submitted to OMB. CDC will publish an additional document in theFederal Registerannouncing OMB's decision to approve, modify, or disapprove the information collection provisions of this final rule. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The collections of information contained in these regulations previously have been reviewed and approved by the Office of Management and Budget under control numbers 1545-1685 and 1545-1686. No material changes to these collections of information are made by these regulations.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.

Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

This document amends 26 CFR parts 1 and 301 to provide modified rules relating to the disclosure of certain tax shelters by corporate investors on their Federal corporate income tax returns under section 6011, the registration of confidential corporate tax shelters under section 6111, and the maintenance of lists of investors in potentially abusive tax shelters under section 6112.

On February 28, 2000, the IRS issued temporary and proposed regulations regarding section 6011 (TD 8877, REG-103735-00), section 6111 (TD 8876, REG-110311-98), and section 6112 (TD 8875, REG-103736-00). The regulations were published in theFederal Register(65 FR 11205, 65 FR 11215, 65 FR 11211) on March 2, 2000.

Based on comments that have been received, the IRS and Treasury have determined that certain interim changes to the temporary and proposed regulations are warranted. The changes in the proposed rules are published elsewhere in this issue of theFederal Register. The interim changes are intended to clarify certain provisions of the regulations, address certain practical problems relating to compliance with the regulations, and make certain other changes relating to the scope of the regulations.

It is anticipated that other changes will be made in the final regulations. The IRS and Treasury have determined that additional time is needed to evaluate a number of the comments and recommendations. The IRS and Treasury continue to invite comments on all provisions of the temporary and proposed regulations, including provisions modified by this document. Furthermore, to the extent that taxpayers or other persons believe that there are specific types of transactions for which disclosure is required under the regulations, and that such disclosure is not consistent with the purposes of the regulations, the IRS and Treasury solicit comments that identify such types of transactions and explain those concerns. Such comments will be taken into account in establishing the scope of the final regulations and will also assist the IRS and Treasury in determining whether there are classes of transactions that should be specifically excepted from disclosure under the final regulations.

The temporary regulations under section 6011 provide that every taxpayer that is required to file a return for a taxable year with respect to any tax imposed under section 11 and that has participated, directly or indirectly, in a reportable transaction shall attach a disclosure statement to its return for each taxable year for which the taxpayer's Federal income tax liability is affected by its participation in the reportable transaction. It has come to the attention of the IRS and Treasury that the temporary regulations under section 6011 may have technically failed to include insurance companies and mutual savings banks conducting life insurance business. The IRS and Treasury intended those corporations to be subject to the disclosure requirement in the regulations. The regulations are amended accordingly.

The temporary regulations under section 6011 provide that a taxpayer must retain all documents relating to a reportable transaction until the expiration of the statute of limitations for the first taxable year for which a disclosure statement is filed with the taxpayer's tax return.

The IRS and Treasury seek to clarify the record retention requirement. As modified, the temporary regulations provide that a taxpayer must retain a copy of all documents and other records related to a transaction subject to disclosure under this section that are material to an understanding of the facts of the transaction, the expected tax treatment of the transaction, or the corporation's decision to participate in the transaction.

Under section 6111(d), a confidential corporate tax shelter must be registered. In describingconfidentiality,the temporary regulations under section 6111(d) provide that if an offeree's disclosure of the structure or tax aspects of the transaction is limited in any way by an express or implied understanding or agreement with or for the benefit of any tax shelter promoter, an offer is considered made under conditions of confidentiality, whether or not such understanding or agreement is legally binding. An offer will also be considered made under conditions of confidentiality in the absence of any such understanding or agreement if any tax shelter promoter knows or has reason to know that the transaction is protected from disclosure or use in any other manner. However, unless the facts and circumstances clearly indicate otherwise, an offer is not considered made under conditions of confidentiality if the tax shelter promoter enters into a written agreement with each person who participates or discusses participation in the transaction and such agreement expressly authorizes such persons to disclose every aspect of the transaction with any and all persons, without limitation of any kind.

The IRS and Treasury understand that, in certain circumstances, limitations on disclosure of the structure or tax aspects of a transaction may be considered necessary to comply with Federal or state securities laws. Consequently, the temporary regulations under section 6111(d) are modified to provide an exception for restrictions on disclosure of the structure or tax aspects of the transaction reasonably necessary to comply with those securities laws.

The IRS and Treasury received comments inquiring whether an exclusivity agreement (i.e.,an agreement requiring the offeree to pay a fee to a promoter if the offeree engages in the transaction, whether or not the offeree uses the services of that promoter) is a condition of confidentiality. It is the view of the IRS and Treasury that an exclusivity agreement is within the scope of section 6111(d)(2)(B) because it is a limitation on use, and the temporary regulations have been clarified to so provide. However, the regulations have also been clarified to provide that an exclusivity arrangement ordinarily will not result in an offer being treated as made under conditions of confidentiality if the tax shelter promoter provides express written authorization for disclosure. As modified, the written authorization rule is applicable if the promoter expressly authorizes each offeree to disclose the structure and tax aspects of the transaction to any and all persons, without limitation of any kind on such disclosure.

In addition, the temporary regulations are modified to provide that, under section 6111(d)(2)(B), limitations on disclosure or use create a condition of confidentiality only if the limitations relate to the structure or tax aspects of the transaction and such limitations are for the benefit of any person other than the offeree.

The temporary regulations under section 6111(d) provide that the termtax shelter promoterincludes a tax shelter organizer under section 6111(e)(1) and § 301.6111-1T(QA-26 through QA-32) and any other person who participates in the organization, management or sale of a tax shelter (other than a person who merely performs services of the kind described in § 301.6111-1T QA-33) or any person related (within the meaning of section 267 or 707) to such tax shelter organizer or such other person.

The IRS and Treasury recognize that the definition of a promoter as currently worded implies that a person can be a promoter by participating in the organization, management or sale of a tax shelter in a way other than as described in section 6111(e)(1) and § 301.6111-1T (QA-26 through QA-32). The regulations under section 6111(d) are amended to clarify that a person is a promoter only if the person participates in the organization, management or sale of a tax shelter under the rules in section 6111(e)(1) and§ 301.6111-1T (QA-26 through QA-33), or is related to such person under section 267 or 707(b).

The regulations are also modified to clarify that only promoters that are classified as organizers under section 6111(e)(1) are required to register tax shelters.

Any person who organizes or sells an interest in a confidential corporate tax shelter must maintain a list of persons who were sold an interest in the tax shelter and such other information as required by section 6112. See § 301.6112-1T. The temporary regulations under section 6112 require that, in addition to the lists required for confidential corporate tax shelters, lists must also be maintained with respect to transactions for which the avoidance or evasion of Federal income tax is considered to be a significant purpose of the structure of the transaction, as determined in section 6111(d)(1)(A) and § 301.6111-2T(b), whether or not the transactions are offered under conditions of confidentiality.

Section 6111(d)(1)(A) provides that the termtax shelterincludes any entity, plan, arrangement, or transaction a significant purpose of the structure of which is the avoidance or evasion of Federal income tax for a direct or indirect participant which is a corporation. The temporary regulations cross-reference section 6111(d)(1)(A) to provide the standard for determining whether the structure of a transaction has a significant purpose of avoidance or evasion of Federal income tax. The temporary regulations are amended to provide that a transaction may be subject to the list maintenance requirement whether or not the transaction is offered to corporate investors. Thus, a list of noncorporate investors will be required to be maintained whether or not the transaction is ever offered to a corporate investor. However, as discussed below, the temporary regulations are modified to include fee and tax reduction thresholds for list maintenance.

Two additional modifications are made to the temporary regulations. First, the definitions of organizer and seller are clarified for purposes of section 6112. Second, the procedure for designating a person to maintain the list under section 6112 is modified for transactions other than section 6111(c) shelters and projected income investments.

The temporary regulations under section 6112 do not limit the investors who must be included on the list. In response to comments, the IRS and Treasury have determined that in certain cases organizers and sellers of interests in potentially abusive tax shelters should be required to include on the list only investors that meet fee and tax reduction thresholds. Accordingly, the temporary regulations under section 6112 are amended to provide that, for a potentially abusive tax shelter that is not required to be registered under section 6111, is not a listed transaction described in § 301.6111-2T(b)(2), and is not a projected income investment as described in § 301.6111-1T A-57A, an organizer or seller of an interest in a shelter may, but is not required to, list an investor if the total consideration paid to all organizers and sellers with respect to such investor's acquisition of the interest is less than $25,000, or if the organizer reasonably believes that such investor's acquisition of the interest will not result in a reduction of the Federal income tax liability of any corporation or corporations that exceeds, or exceeds in the aggregate, $1 million in any single taxable year or a total of $2 million for any combination of taxable years and will not result in a reduction of the Federal income tax liability of any noncorporate taxpayer or taxpayers that exceeds, or exceeds in the aggregate, $250,000 in any single taxable year or a total of $500,000 for any combination of taxable years.

The regulations are applicable August 11, 2000. However, in general, taxpayers may rely on the regulations after February 28, 2000.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. Because these regulations impose no new collection of information on small entities, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Internal Revenue Code, these temporary regulations will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

The principal author of these regulations is Catherine Moore, Office of the Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and Treasury Department participated in their development.

Although this rule is being published as a temporary final rule without prior notice, an opportunity for public comment is nevertheless desirable to ensure the rule is both reasonable and workable. Accordingly, we encourage you to submit comments and related material. If you do so, please include your name and address, identify the docket number (CGD05-00-033), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related materials in an unbound format, no larger than 8.5 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope.

A notice of proposed rulemaking (NPRM) was not published for this regulation. In keeping with 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. The Coast Guard received confirmation of the request for special local regulations on July 6, 2000. We were notified of the event with insufficient time to publish a NPRM, allow for comments, and publish a final rule prior to the events.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. We had insufficient time to prepare and publish this rule in theFederal Register30 days in advance of the events. To delay the effective date of the rule would be contrary to the public interest since a timely rule is necessary to protect mariners from the hazards associated with the fireworks displays.

The Maryland Public Purchasing Association, Inc. and the National Institute of Governmental Purchasing, Inc. will sponsor a fireworks display on August 20, 2000. The fireworks display will be held over the waters of the Patapsco River, Inner Harbor, Baltimore, Maryland. The event will consist of a pyrotechnic display launched from a barge positioned in the Inner Harbor. A fleet of spectator vessels is anticipated. Due to the need for vessel control during the fireworks display, vessel traffic will be temporarily restricted to provide for the safety of spectators and transiting vessels. The rain date for the event is August 21, 2000.

The Coast Guard is establishing temporary special local regulations on specified waters of the Patapsco River. The temporary special local regulations will be in effect from 9:15 p.m. to 11:30 p.m. on August 20, 2000 and will restrict general navigation in a regulated area during the fireworks display. If inclement weather prevents the event from taking place on August 20, 2000, the temporary special local regulations will be effective from 9:15 p.m. to 11:30 p.m. on August 21, 2000. The temporary special local regulations are scheduled to be enforced for approximately twenty minutes during the two hour effective time period. The anticipated enforcement time is 9:15 p.m. to 9:50 p.m. on the effective date. If weather or other unforeseen circumstances causes a delay, an updated enforcement time will be provided via a Marine Safety Radio Broadcast on VHF-FM marine band radio, Channel 22 (157.1 MHz). Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area during the enforcement time period. These regulations are needed to control vessel traffic during the fireworks display to enhance the safety of spectators and transiting vessels.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979).

We expect the economic impact of this temporary final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

Although this regulation prevents traffic from transiting a portion of the Patapsco River during the event, the effect of this regulation will not be significant due to the limited duration of the regulation and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not havea significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in the effected portions of the Patapsco River during the event.

Although this regulation prevents traffic from transiting or anchoring in portions of the Patapsco River during the event, the effect of this regulation will not be significant because of its limited duration and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

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

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule will not impose an unfunded mandate.

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

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

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

We considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” will be available in the docket where indicated underADDRESSES.This rule will have no impact on the environment.

LPG carriers are scheduled to transit through Tampa Bay and into a new LPG facility located on Port Sutton Channel. Due to the hazards to other vessels and to the public associated with carrying LPG product, the Coast Guard is establishing a moving safety zone. The safety zone will mirror the current guidelines for vessels carrying anhydrous ammonia that are currently calling on the Port of Tampa. The Safety Zone will also prohibit vessels from entering within 1000 yards fore or aft of the vessel during its transit.

In accordance with 5 U.S.C. 553, a notice of proposed rulemaking has not been published for these regulations and good cause exists for making them effective in less than 30 days afterFederal Registerpublication. Publishing a NPRM and delaying its effective date would be contrary to national safety interests since immediate action is needed to minimize potential danger to the public, as the updated information concerning the time and location of the transit was received 10 days before the transit.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of the order. It has been exempted from review by the Office of Management and Budget under that order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979). The Coast Guard expects the economic impact of this proposal to be so minimal that a full regulatory evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This regulation is needed to ensure public safety in a limited area of Tampa Bay.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities as the regulations will only be in effect for two (2) hours on a limited area of Tampa Bay and meeting or overtaking of the vessel is permitted between Gadsden Cut buoys #3 and #7.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-221), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small entities may contact the person listed underFOR FURTHER INFORMATION CONTACTfor assistance in understanding and participating in this rulemaking. We also have a point of contact for commenting on actions by employees of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule contains no collection of information requirements under the Paperwork Reduction Act (44 U.S.C. 3501et seq.)

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

This rule will not effect a taking of private property or otherwise have taking disproportionately affect children.

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

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

The Coast Guard has considered the environmental impact of this action and has determined under figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1C, that this rule is categorically excluded from further environmental documentation.

On March 13, 2000, the Postal Service published in theFederal Registera proposed rule to amend section D042.2.6e of the Domestic Mail Manual (65 FR 13258-13260). The original rule was published as part of a comprehensive clarification and revision of rules concerning delivery of mail to commercial mail receiving agencies (CMRAs) published on March 25, 1999 (64 FR 14385-14391). DMM section D042.2.6e established specific provisions for addressing mail to a holder of a private mailbox at a CMRA. As originally promulgated, the standard provided that the address must include a specific secondary address designation: “PMB” (for “private mailbox”) followed by a number assigned to the boxholder by the CMRA. Under the proposed change, CMRA private mailbox holders would have the option to use either “PMB” or “#” as the secondary address designation.

The secondary address designation, as discussed in the proposed rule and earlier notices regarding the CMRA standards, was intended to serve consumer protection interests. Previously, postal regulations had not prescribed the manner in which mail to CMRA private mailbox holders must be addressed, and many private mailbox holders have used a designation (e.g.,“Suite” or “Apartment”) along with the street address of the CMRA. This practice implied to senders of mail that the boxholder maintained a physical presence at that location. These addressing practices create the opportunity for fulfillment of criminal fraud schemes. However, and as described in some comments, even where this was not the case, the practice may be deceptive to consumers or others. For example, consumers who desire to provide charitable donations to local organizations or to make purchases from local businesses might mistakenly believe they are doing so when they respond to an out-of-state organization or firm with an address at a local CMRA. For similar reasons, the local business or charity might also suffer a competitive disadvantage from this practice.

Accordingly, the original rule was intended to serve consumer protection interests by providing the public with a means to be aware whether an address represented a physical location. However, the Postal Service later became aware the standard might have an unintended consequence. In meetings with industry representatives, it was pointed out that the “PMB” designation might adversely affect small businesses. The March 13, 2000, proposal, which permitted the use of either “PMB” or “#” as the secondary address designation, was intended as a means to balance the consumer and small business interests.

The Postal Service received 20,456 comments on the rulemaking. These were roughly comprised of three groups. The largest group (20,153 comments) supports the rulemaking. These comments, which were generally submitted by CMRA owners or private mailbox holders, were identical in content and format, and favored adopting the use of “PMB” or the optional “#” as the secondary designation. It also appears likely from the submissions that many of the commenters view this as a compromise, and that they would be at least as satisfied with the elimination of any required secondary address designation. However, if a secondary address designation was required, these commenters considered “#” to be preferable to “PMB.”

The smallest group (12 comments) expressly opposes the requirement for a secondary address designation. Representatives of small business groups and some CMRA private mailbox holders submitted these comments. They questioned whether there are appreciable fraud statistics to support the need for CMRA regulations. Some of these comments also appear to oppose any postal standards concerning the delivery of mail to CMRAs. To the extent these comments concern standards other than those proposed in DMM D042.2.6e, they are beyond the scope of this rulemaking.

The remaining 291 comments oppose the proposed rule that allows the use of “PMB” or the optional “#” as the secondary designation. These comments were generally submitted by groups representing consumer protection constituencies, such as state attorney generals, an association of state charity officials, and an association of financial crimes investigators, as well as address list maintenance vendors, an association of presort mailers, major mailers, individual consumers, and private mailbox holders. These commenters urge the requirement for use of the “PMB” secondary address designation be retained without an option to use “#” as an alternative. They observe the “#” designation may be confusing to senders of mail, who believe it represents a physical location. The comments also question whether the use of “PMB” will adversely affect small businesses, and, in any event, assert private mailbox holders should not be permitted to use addresses that falsely imply a physical presence at the location. Significantly, some commenters appear to believe that, as proposed, D042.2.6e would have a negative impact on consumer protection interests.

Based on its review of the current record, the Postal Service has determined to adopt the proposed revision to DMM D042.2.6e that allows the use of “PMB” or the optional “#”, in certain conditions, as the secondary address designation for a CMRA customer.

At the outset, it should be noted that the Postal Service rejects any assertion that it lacks authority to promulgate rules to protect consumer protection interests. The Postal Reorganization Act establishes Postal Service responsibilities to protect citizens from fraudulent and deceptive practicesthrough use of the mails. The Postal Service efforts in this area are widespread and ongoing; these efforts are not targeted at CMRAs. They include initiatives directed at frauds conducted through post office boxes; street addresses (rural and city delivery); and anywhere else, including fraudulent solicitations appearing first on the Internet that direct payment and shipment through the mails. Moreover, an important part of any anti-fraud strategy incorporates preventive means and consumer education so those consumers can protect themselves before becoming a victim. The modifications to the CMRA addressing standards reduce the possibilities consumers may be misled or confused by certain mailing address terminology. It is also noted that virtually all commenters and organizations that have participated in this process have voiced their support for protection of consumer interests and the Postal Service's role in this area.

The Postal Service disagrees with comments that DMM section D042.2.6e, especially as amended, will be harmful to small business interests. Discussions with CMRA industry representatives, who certainly have an interest in protecting their clientele, prior to the publication of the proposed rule and comments received from these interests and many CMRA owners and private mailbox holders support the conclusion that the proposal provides a viable compromise for small businesses.

Some commenters contend the “#” will cause D042.2.6e to be meaningless and ineffective, if not counterproductive. They observe that businesses should not be permitted to imply to potential customers that they are physically located at an address when that is not true, even if that deception is merely used by reputable businesses to obtain a competitive edge rather than for criminal purposes. These consumer advocates assert the use of “#” currently implies a “suite” or “apartment” and that addressees will continue in the future to assume that it implies a physical location at that address.

The Postal Service understands these concerns. Indeed, absent measures to ensure consumers will have the means to understand what “#” may mean and tools to determine whether a specific address is located at a CMRA, the concerns could warrant withdrawal of the rulemaking. However, the Postal Service and the CMRA industry will jointly implement the following initiatives with the hope of minimizing these possibilities:

1. Educate the public on the meanings of both the “PMB” and “#” designations. The Postal Service also stands ready to work with both the CMRA industry and consumer groups to design these materials and the means to distribute them to maximize public awareness.

2. The Postal Service will establish methods (toll-free number and/or Postal Service Web site) that can be accessed to determine whether a street address is the location of a CMRA. This will enable persons who receive mail with a “#” designation to determine whether the sender is a CMRA boxholder.

3. The Postal Service will continue efforts to work directly with the CMRA industry to address areas of continued concern. The industry is working with the Postal Service to ensure implementation of the postal standards concerning delivery of mail to CMRAs. Additionally, some industry members voluntarily participate in a Postal Inspection Service training program to recognize and report improper activity at CMRA locations.

4. The Postal Inspection Service has improved its data collection regarding the number of cases involving the use of off-premises delivery services, including post office boxes, for fraudulent purposes.

In view of these steps, the Postal Service adopts the proposal to allow the use of the “#” sign as an additional secondary addressing option for CMRA boxholders.

Several other aspects of the rulemaking also bear explanation.The standard adopted on March 25, 1999, required the use of a four-line address format. Under the final rule, this remains the preferred format. However, it was proposed that customers have the option to use a three-line format, with one exception, where the “#” secondary address designation is used and the physical address of the CMRA contains a secondary address designation, or the delivery address is a rural route box style address. In these limited instances, use of the “#” designation is not allowed, which is necessary to ensure the Postal Service's automated equipment can accurately process the mail. The new standards accommodate these desires to use a three-line format, as long as that mail can be effectively processed by Postal Service equipment.

The effective date of section D042.2.6e is August 1, 2001.Whenever possible, the Postal Service encourages mailers to use the new standards earlier. Nevertheless, the extended deadline for compliance with the standard is consistent with the Postal Service's goal of minimizing the implementation costs to CMRAs and their customers. It allows CMRA customers to deplete existing stationery and to advise correspondents of the new designation in the ordinary course of business.

For the reasons discussed above, the Postal Service hereby adopts the following amendments to the Domestic Mail Manual, which is incorporated by reference in the Code of Federal Regulations (see 39 CFR part 111.1).

As required under title V of the Clean Air Act (“the Act”) as amended (42 U.S.C. 7401et seq.), EPA has promulgated rules that define the minimum elements of an approvable State operating permit program and the corresponding standards and procedures by which the EPA will approve, oversee, and withdraw approval of State operating permit programs (see 57 FR 32250 (July 21, 1992)). These rules are codified at 40 Code of Federal Regulations (CFR) part 70 (“part 70”). Title V directs States to develop, and submit to EPA, programs for issuing operating permits to all major stationary sources and to certain other sources.

The Act directs States to develop and submit operating permit programs to the EPA by November 15, 1993, and requires that EPA act to approve ordisapprove each program within one year after receiving the submittal. The EPA's program review occurs pursuant to section 502 of the Act (42 U.S.C. 7661a) and the part 70 regulations, which together outline criteria for approval or disapproval. Where a program substantially, but not fully, meets the requirements of part 70, EPA may grant the program interim approval. If EPA has not fully approved a program by two years after the November 15, 1993 date, or before the expiration of an interim program approval, it must establish and implement a federal program.

The State of Colorado was granted final interim approval of its program on January 24, 1995 (see 60 FR 4563) and the program became effective on February 23, 1995. Interim approval of the Colorado program expires on December 1, 2001.

The Governor of Colorado submitted an administratively complete Title V operating permit program for the State of Colorado on November 5, 1993. This Colorado program, including the operating permit regulations at part C of Regulation No. 3, substantially met the requirements of part 70. EPA deemed the program administratively complete in a letter to the Governor dated January 4, 1994. The program submittal included a legal opinion from the Colorado Attorney General stating that the laws of the State provide adequate legal authority to carry out all aspects of the program, a description of how the State would implement the program regulations, application and permit forms, and a permit fee demonstration.

EPA's comments noting deficiencies in the Colorado program were sent to the State in a letter dated April 8, 1994. The deficiencies were segregated into those that would require corrective action prior to interim program approval, and those that would require corrective action prior to full program approval. The State committed to address the program deficiencies that would require corrective action prior to interim program approval in a letter dated May 12, 1994, and subsequently held a public hearing to consider and adopt the necessary changes on August 18, 1994.

The State submitted its revised part 70 program and a supplemental Attorney General's opinion with letters dated September 29, 1994 and October 3, 1994. EPA reviewed these corrective actions and determined them to be adequate to allow for interim program approval. On January 24, 1995, EPA published aFederal Registerdocument promulgating final interim approval of the Colorado program. See 60 FR 4563.

Areas of the Colorado program that were identified by EPA in the January 24, 1995Federal Registeras deficient and the State's corrective actions for full program approval are as follows:

(1) The State was required to revise its administrative process in section II.D.5 of part A of Air Quality Control Commission Regulation 3, for adding additional activities to the list of insignificant activities allowed as exemptions under 40 CFR 70.5(c), to require approval by the EPA of any new exemptions before such exemptions can be utilized by a source.

Correction:In a letter dated March 7, 1996, the State submitted a copy of Colorado's revised section II.D.5 of part A of Regulation No. 3, adopted August 17, 1995, requiring EPA approval of any new additions to the State's insignificant activities list. EPA reviewed the revised regulation and determined that it is adequate to allow for full program approval.

(2) The State was asked to revise the Colorado Air Quality Control Act (Colo. Rev. Stat. section 25-7-109.6(5)(1999)) to remove the condition that an accidental release prevention program pursuant to section 112(r) of the Act will only be implemented if Federal funds are available. A guidance memo, dated April 13, 1993, from John Seitz, Director of the Office of Air Quality Planning and Standards, entitled “Title V Program Approval Criteria for Section 112 Activities” provides that in order to obtain full Title V approval from EPA the State must have authority to “* * * issue Part 70 permits that assure compliance with all currently applicable requirements * * *”. Such requirements include requirements under section 112(r)(7) of the Act for certain sources to prepare and implement a risk management plan to prevent and minimize accidental releases of hazardous air pollutants, and to submit the plan to EPA.

Correction:In a letter dated March 13, 1996, the State indicated that it does comply with the April 13, 1993 memorandum from John Seitz and has the necessary authority to implement all of the current requirements of section 112, including section 112(r). This position was affirmed in an opinion letter from the Office of the Attorney General for the State of Colorado, dated June 23, 1997. The opinion concluded that, although State law prohibited Colorado from establishing its own section 112(r) accidental release program in the absence of federal funding, the State had adequate authority to incorporate pertinent requirements from the federal program in State-issued Title V operating permits and, therefore, a statutory amendment would not be required to comply with Title V. EPA concurred with the State's opinion, as discussed in a letter from Richard Long, dated July 9, 1997.

In addition to providing the opinion letter, the State made a commitment to work toward resolving any issues that the final 112(r) rule might raise. The final 112(r) rule, which was promulgated on June 20, 1996, did not require additional involvement by the State and thus raised no new issues. See 40 CFR 68.215; see also 61 FR 31728 (June 20, 1996). Therefore, after further review, EPA believes that the State of Colorado has authority to implement all the section 112(r) requirements that are necessary for full program approval.

In a letter dated June 24, 1997, Colorado documented its actions that corrected the interim approval deficiencies and requested EPA's review and full approval of its program. The letter also acknowledged that full approval action might be delayed because EPA had identified concerns that Colorado's audit privilege and immunity law (SB 94-139) (“self-audit law”) might impair the State's ability to enforce federally authorized programs, including the Title V program. After lengthy negotiations between EPA and the State, Colorado proposed to amend the self-audit law. The statutory amendments were adopted by the State legislature and signed by the Governor on May 30, 2000.

In addition, on April 14, 2000, the Attorney General for Colorado issued a formal opinion interpreting various provisions of the self-audit law, resolving certain other enforcement issues not addressed by the statutory amendments. Finally, on May 30, 2000, EPA and the State of Colorado entered into a memorandum of agreement concerning implementation of the self-audit law. The memorandum of agreement was intended as a companion document to be read in conjunction with the Attorney General's April 14 opinion.

Taken altogether, the statutory amendments, the Attorney General's opinion, and the memorandum of agreement effectively resolved all the issues EPA identified concerning the effect of the self-audit law on Colorado's ability to enforce federally authorized programs. Accordingly, EPA is free to proceed with rulemaking to grant full approval of the Colorado Title V program.

Requirements for program approval, specified in 40 CFR 70.4(b), encompass requirements under section 112(l)(5) of the Act for delegation of National Emission Standards for Hazardous Air Pollutants (NESHAPs) promulgated by EPA under 40 CFR parts 61 and 63, as well as other section 112 standards and requirements. Section 112(l)(5) requires that the State's hazardous air pollutant control program contain adequate authorities to implement and enforce the program, adequate resources for implementation, and an expeditious compliance schedule.

These criteria are also requirements for approval of a State operating permit program under part 70. Because Colorado had satisfied those requirements, EPA granted approval of the State's program under section 112(l)(5) and 40 CFR 63.91, for receiving delegation of section 112 standards that are unchanged from the Federal standards, in theFederal Registerdocument promulgating final interim approval of the Colorado operating permit program. See 60 FR 4563, 4568.

EPA's approval of Colorado's section 112(l) program was limited, however, to delegation of standards as they apply to part 70 sources. Based on the State's request, dated February 2, 1996, EPA is expanding this approval to include non-part 70 sources. EPA believes that this expanded approval is warranted, because State law does not differentiate between part 70 and non-part 70 sources for purposes of implementation and enforcement of section 112 standards that the State has adopted. This approval establishes a basis for the State to receive direct delegation of authority to implement and enforce, for non-part 70 sources, section 112 standards that the State adopts without change from the federal standards. Such direct delegation includes section 112 standards that EPA may promulgate in the future. See 61 FR 36295 (July 10, 1996).

In this document, EPA is granting full approval of the Colorado part 70 operating permit program for all areas within the State except the following: any sources of air pollution located in “Indian Country” as defined in 18 U.S.C. 1151, including the following Indian reservations in the State: Southern Ute Indian Reservation and the Ute Mountain Ute Indian Reservation, or any other sources of air pollution over which an Indian Tribe has jurisdiction. See section 301(d)(2)(B) of the Act; see also 63 FR 7254 (February 12, 1998).

The term “Indian Tribe” is defined under the Act as “any Indian tribe, band, nation, or other organized group or community, including any Alaska Native village, which is federally recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians.” See section 302(r) of the Act; see also 58 FR 54364 (October 21, 1993).

Based on the State's request, EPA is also expanding its approval of the State's program under section 112(l)(5) of the Act and 40 CFR 63.91 for receiving delegation of section 112 standards that are unchanged from the Federal standards, to include non-part 70 sources.

The EPA is publishing this rule without prior proposal because the State is currently implementing its part 70 program and the Agency views this as a noncontroversial action and anticipates no adverse comments. However, in the proposed rules section of thisFederal Registerpublication, EPA is publishing a separate document that will serve as the proposal to grant full approval of the operating permit program submitted by the State of Colorado should adverse comments be filed. This rule will be effective October 16, 2000, without further notice unless the Agency receives adverse comments by September 15, 2000.

If the EPA receives such comments, then EPA will publish a timely withdrawal in theFederal Registerinforming 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 action. Any parties interested in commenting on this rule must do so at this time.

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

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Order 12612 (Federalism) and Executive Order 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. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

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 by Executive Order 12866, and it does not establish a further health or risk-based standard because it approves state rules which implement a previously promulgated health or safety-based standard.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly 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.

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.

This final 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.

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

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. 801et 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 theFederal 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 October 16, 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).)

I. General Information A. Does this Action Apply to Me?

The Agency included in the final rule a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed underFOR 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 theFederal Registerlistings at http://www.epa.gov/fedrgstr/.

2.In person. The Agency has established an official record for this action under docket control number OPP-301028. 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 technical correction corrects the table in 40 CFR 180.176(b) to clarify that the tolerance for mancozeb use on ginseng expires on 12/31/01. In theFederal Registerof May 24, 2000, two amendments to the mancozeb tolerance regulation were issued. At page 33472 (FRL-6556-9) the expiration/revocation date for mancozeb use in or on ginseng shown in the table to § 180.176(b) was revised to read 12/31/01. On page 33708 (FRL-6043-1), § 180.176 was revised in its entirety. In this amendment, the expiration date for ginseng in the table to paragraph (b) reads “12/31/99”. The correct expiration/revocation date for mancozeb use on gingeng is “12/31/01” as is shown in the amendment at page 33472. This technical correction both clarifies and corrects the expiration/revocation date of mancozeb use on ginseng as found in 40 CFR 180.176(b). Because the Office of the Federal Register has to include the latest amendment in the Code of Federal Regulations (CFR), it is necessary that EPA issue this correction to insure that the correct expiration/revocation date is shown in the CFR.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment, because EPA is correcting and clarifying the tolerance for mancozeb use in or on ginseng that was previously published in theFederal Register. The preamble to the previously published Final Rule discussed how the number average molecular was one of the criteria for identifying low risk polymers. Thus, notice and public procedure are unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

No. This final rule implements a technical amendment to the CFR to reflect a technical correction to a previously issued Final Rule, and it does not otherwise impose or amend any requirements. As such, the Office of Management and Budget (OMB) has determined that a technical correction is not a “significant regulatory action” subject to review by OMB under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Nor does this rule contain any information collection requirements that require review and approval by OMB pursuant to the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.).

Because this action is not economically significant as defined by section 3(f) of Executive Order 12866, this action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action will not result in environmental justice related issues and does not, therefore, require special consideration under Executive Order 12898, entitled Federal Actions to AddressEnvironmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since the Agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the APA or any other statute (see Unit III above), this action is not subject to provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. Nor does this action significantly or uniquely affect the communities of tribal governments as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (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, entitled Federalism (64 FR 43255, August 10, 1999). This action does not involve any technical standards that require the Agency's 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). 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 foraffected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this 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.

For information about the applicability of the regulatory assessment requirements to the final rule that was issued on May 24, 2000 (65 FR 33703) (FRL-6041-9), please refer to the discussion in Unit III of that document.

Yes. The Congressional Review Act (CRA), 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. Section 808 allows the issuing agency to make a rule effective sooner than otherwiseprovided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. (5 U.S.C. 808(2). EPA has made such a good cause finding for this final rule, and established an effective date of May 24, 2000. Pursuant to 5 U.S.C. 808(2), this determination is supported by the brief statement in Unit III of this document. 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 theFederal Register. This is not a “major rule” as defined by 5 U.S.C. 804(2).

I. General Information A. Does this Action Apply to Me?

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 underFOR FURTHER INFORMATION CONTACT.

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

2.In person. The Agency has established an official record for this action under docket control number OPP-301036. 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.

EPA issued a final rule, published in theFederal RegisterofAugust 13, 1997 (62 FR 43284) (FRL-5735-2), which announced that on its own initiative under 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) it established time-limited tolerances for the combined residues of propiconazole and its metabolites in or on sorghum, grain, grain at 0.2 ppm; sorghum,grain, stover at 1.5 ppm; and sorghum, aspirated grain fractions at 20 ppm, with an expiration date of July 31, 1998.

EPA also issued a final rule, published in theFederal Registerof April 11, 1997 (62 FR 17710) (FRL-5600-5), which announced that on its own initiative under section 408 of the FFDCA, 21U.S.C. 346a, as amended by the FQPA (Public Law 104-170) it established a time-limited tolerance for the combined residues of propiconazole and its metabolites in or on cranberries at 41.0 ppm, with an expiration date of July 31, 1998. The tolerance level was corrected to be 1.0 ppm in theFederal Registerof May 2, 1997 (62 FR 24045) (FRL-5783-5).

EPA additionally issued a final rule, published in theFederal Registerof June 13, 1997 (62 FR 32224) (FRL-5718-8), which announced that on its own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170) it established time-limited tolerances for the combined residues of propiconazole and its metabolites in or on dry beans at 0.5 ppm; dry bean forage at 8 ppm and dry bean hay at 8 ppm, with an expiration date of December 31, 1998.

EPA also issued a final rule, published in theFederal Registerof January 20, 1999 (64 FR 2995) (FRL-6049-8), which announced that on its own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170) it established time-limited tolerances for the combined residues of propiconazole and its metabolites in or on blueberries and raspberries at 1.0 ppm, with an expiration date of December 31, 1999.

EPA established these tolerances because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of the FIFRA. Such tolerances can be established without providing notice or period for public comment.

EPA received requests to extend the use of propiconazole on blueberries andcranberries for this year's growing season due to the continued emergency situation facing blueberry and cranberry growers due to the cancellation of the fungicide triforine, which was the only product registered to control cottonball disease in cranberries or mummy berry disease in blueberries. Raspberry growers in Oregon and Washington requested the use of propiconazole be extended due to wet and mild weather conditions in the Pacific Northwest which result in severe disease pressure from yellow rust. Disease pressure from sorghum ergot and rust led the sorghum and dry bean growers, respectively, to request the use of propiconazole on these crops. After having reviewed these submissions, EPA concurs that emergency conditions exist for these growers. EPA has authorized under FIFRA section 18 the use of propiconazole on sorghum for control of sorghum ergot in Kansas, Nebraska, New Mexico, Oklahoma and Texas; the use on dry beans for control of rust in Kansas, Minnesota, and North Dakota; the use on blueberries for control of mummy berry disease in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Washington; the use on cranberries for control of cottonball disease in Washington and Wisconsin; and the use of propiconazole on raspberries for control of yellow rust in Oregon and Washington.

EPA assessed the potential risks presented by residues of propiconazole in or on the above commodities. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rules of April 17, 1997 (62 FR 17710) (FRL-5600-5), June 13, 1997 (62 FR 32224) (FRL-5718-8), August 13, 1997 (62 FR 43284) (FRL-5735-2), and January 20, 1999 (64 FR 2995) (FRL-6049- 8). Based on that data and information considered, the Agency reaffirms that extension of the time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances for sorghum and cranberries are extended for an additional 17-month period; the time-limited tolerances for dry beans, blueberries and raspberries are extended for an additional 1-year period. EPA will publish a document in theFederal Registerto remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on December 31, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on blueberries; cranberries; raspberries; dry beans; dry bean forage; dry bean hay; sorghum grain, sorghum grain, grain; sorghum grain, stover; and sorghum aspirated grain fractions after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerances. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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 toreflect 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-301036 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 October 16, 2000.

1.Filing the request. Your objection must specify thespecific 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 requesta 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 judgementof 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 objectionor hearing request with the Hearing Clerk as described in Unit III.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-301036, 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 extends time-limited tolerances under FFDCA section 408.The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory 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. 3501et 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, entitledConsultation and Coordination with Indian Tribal Governments(63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitledFederal 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, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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, entitledFederalism(64 FR 43255, August 10, 1999). Executive Order 13132 requiresEPA 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. 801et seq., asadded 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

I. General Information A. Does this Action Apply to Me?

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

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

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

2.In person. The Agency has established an official record for this action under docket control number OPP-301039. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI).This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of the insecticide coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate, in or on honey at 0.1 part per million (ppm) and beeswax at 100 ppm. These tolerances will expire and are revoked on December 31, 2002. EPA will publish a document in theFederal Registerto remove the revoked tolerance from the Code of Federal Regulations.

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

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

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

The varroa mite (Varroa jacobsoniOudemans) is an ectoparasite of honey bees. It was first detected in the continental United States in Maryland in 1979, and found in Florida and Wisconsin by 1987. Currently it is the most important pest of honey bee colonies. The mites feed on the hemolymph of the developing bee larva, pupa, and adult bees. Dead or dying newly emerged bees have malformed wings, legs, abdomens, and thoraces. Recent anecdotal evidence suggests that bee viruses and varroa mites are closely linked to the demise of honey bee colonies. The mites have been shown to activate some of these, usually benign, viruses; causing virus outbreaks that ultimately lead to colony mortality.

Fluvalinate is currently registered for the control of varroa mites however, populations of varroa mites have developed resistance to fluvalinate. Varroa mite resistance to fluvalinate has been well documented by the United States Department of Agriculture (USDA), Agricultural Research Service (ARS). According to USDA, ARS many hives treated with fluvalinate have resulted in wholesale colony losses. Due to the destructive nature of this pest coupled with the importance of honey bees (for honey production and pollination of numerous agricultural crops) to the U.S. economy, it is imperative that alternative means of controlling the varroa mite be developed. Currently, coumaphos is the only pesticide that has been identified as an effective alternative to fluvalinate. Extensive efficacy trials, performed in laboratories in the U.S.A. and abroad, have revealed that coumaphos will significantly reduce populations of varroa mites without causing any appreciable mortality to adult honey bees or their brood.

The small hive beetle (Aethina tumidaMurray) was discovered for the first time in the continental U.S. (in Florida) in May 1998. The beetles infest European honey bee colonies and feed on stored pollen and honey. The adult beetles have a thick integument that protects them from bee stings. Hive combs are destroyed and developing bee broods are killed by the burrowing of the beetle larvae throughout the hive. Also, the excrement of these hive beetles fouls the honey, reducing its quality. Currently there are no pesticides registered for the control of small hive beetles.

The Agency has authorized the use of coumaphos under section 18 of FIFRA for the use of coumaphos impregnated in plastic strips to be hung in beehives to control varroa mites and small hive beetles to 45 States. To date based on studies conducted by USDA, ARS, no chemical other than coumaphos is available that provides reliable, effective control of both varroa mites and/or small hive beetles. To date, resistant strains of honey bees, biological control methods, and the use of other natural products are not completely functional management practices. The EPA did register formic acid during 1999. However it is only registered for suppression of varroa mites and is not labeled for control of small hive beetles. USDA, ARS has stressed that formic acid alone is not a viable replacement for fluvalinate.

The Agency has concluded that not only would beekeepers be adversely impacted if these emergency exemptions were not granted but that the impact on much of agriculture in the United States could be dire. That is, if coumaphos is not made available to control varroa mites and small hive beetles beekeepers and honey producers in at least 45 states will suffer significant economic losses. Additionally, much of agriculture in America will be adversely impacted. Few feral bee colonies remain in the United States due to disease and insect pressure (including that from varroa mites), increasing the American farmers dependency on managed bees for pollination. Over 150 crops have been identified that require bees for pollination. Based on figures published by the National Agricultural Statistics Service of USDA the estimated value of increased yield and quality achieved through pollination by honey bees is 14.6 billion dollars per year.

In 1999, based on limited residue data available in which honey and wax samples were collected from brood chambers, the Agency concluded that there would be no reasonable expectation of residues of coumaphos in commercial honey and processed beeswax used for food (taken from the honey supers) provided that the coumaphos strips were used in brood chambers when honey supers were not present (in accordance with the section 18 authorization letter). Therefore, the section 18 use was classified as a non-food use and no tolerances were established in either honey or beeswax. However, based on additional information submitted to the Agency in 2000 the non-food use classification is no longer supportable and establishing tolerances for honey and beeswax is necessary.

EPA has authorized under FIFRA section 18 the use of coumaphos in beehives for control of varroa mites and small hive beetles in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming. After having reviewed these submissions, EPA concurs that emergency conditions exist.

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

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether coumaphos meets EPA's registration requirements for use on honey and beeswax or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of coumaphos by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any other State to use this pesticide in beehives under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for coumaphos, contact the Agency's Registration Division at the address provided underFOR FURTHER INFORMATION CONTACT.

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of coumaphos and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate in or on honey at 0.1 ppm and beeswax at 100 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For coumaphos an extra UF of 3 (for a total UF of 300) was applied for acute dietary, short term inhalation, and intermediate term inhalation assessments to account for the lack of a NOAEL in the toxicology studies identified for use in these risk assessments.

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 × 10- 6or 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 istypically 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 (MOEcancer= point of departure/exposures) is calculated.

1.Dietary exposure from food and feed uses. Coumaphos is an acaricide currently registered for use on livestock animals for the control of arthropod pests. Tolerances have been established (40 CFR 180.189) for the combined residues of coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate, in or on meat, fat, and meat byproducts of cattle, goats, hogs, horses, poultry, and sheep, and in milk and eggs. Tolerances are set at 1.0 ppm in livestock tissues, 0.5 ppm in milk-fat residues, and 0.1 ppm in eggs. Although tolerances are still listed in the most recent CFR (revised July 1, 1999) for sheep, goats, and poultry (1.0 ppm) and eggs (0.1 ppm), the use of coumaphos on poultry (eggs) has been canceled and the use of coumaphos on goat and sheep are no longer supported by the technical registrant and will be deleted. Therefore, these commodities are not included in the dietary risk analysis. Risk assessments were conducted by EPA to assess dietary exposures from coumaphos 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 acute analysis for coumaphos is a highly refined (Tier 3 Monte-Carlo) estimate of dietary exposure from residues in food. The following assumptions were made for the acute exposure assessments: use of anticipated residues information for livestock, percent livestock treated information, monitoring data from the USDA PDP program for livestock and monitoring data collected for honey samples treated in 1999 and 2000 under the emergency exemptions from Sioux Honey Association.

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 CSFII and accumulated exposure to the chemical for each commodity. The chronic analysis for coumaphos is a refined estimate of dietary exposure from residues in food. The following assumptions were made for the chronic exposure assessments: use of anticipated residues information for livestock, percent livestock treated information, monitoring data from the USDA PDP program for livestock and monitoring data collected for honey samples treated in 1999 and 2000 under the emergency exemptions from Sioux Honey Association.

iii.Cancer. Coumaphos is classified as Group E (no evidence of carcinogenicity in humans).

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 the following percent livestock treated (PLT) information: 5%% beef (and horse) including lean meat without removable fat, beef fat, beef liver, beef byproducts, kidney; 1%% hog including meat, hog fat, hog liver, hog byproducts, and hog kidney; 100%% veal including lean meat without removable fat, veal fat, veal liver, veal meat by-products, and veal kidney; and 4%% milk. Anticipated residue values (ARs) were calculated from field trial data for estimation of both acute and chronic dietary exposure for all livestock commodities, with the exception of milk. The residue values used for milk are from the USDA's PDP 1997 and 1998 monitoring data which show no detectable residues in milk out of 750 samples tested. Anticipated residues used for honey were based on monitoring data provided by Sioux Honey Association. These data represent raw honey samples which were likely to be treated under Section 18 exemptions in 1999 and 2000. Only those samples with detectable or quantifiable residues (limit of detection = 1 ppb) of coumaphos (parent) were included in the anticipated residue calculations. Some samples were analyzed more than once. In those cases the average value of the multiple analyses was used to calculate the residue level for chronic exposure, whereas the highest value was chosen for the acute analysis.

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

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a tier 1model) 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 coumaphos they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of coumaphos in surface water and ground water, respectively, for acute exposures are estimated to be 1.9 parts per billion (ppb) for surface water and 0.17 ppb for ground water. The EECs for chronic exposures are estimated to be 0.41 ppb for surface water and 0.17 ppb for ground water. Note, in the Revised Risk Assessment for Coumaphos, released by the Agency as published in theFederal Registerof April 26, 2000 (65 FR 24468) (FRL-6556-7), with the comment period ending June 26, 2000, the estimated EECs for surface and ground water are different than those reported above. Based on the available environmental data, the Kocvalue for the parent coumaphos is 3,994 to 11,422. In the Revised Risk Assessment for Coumaphos, in absence of data on the degradate coumaphoxon, it was assumed that the Kocvalue for coumaphoxon was 0.1. Therefore, the EECs values represented an overly conservative exposure assessment. For this risk assessment the Agency used a computer estimation program (EPI version 3.04) to estimate a more realistic Kocvalue of 92.3 and water solubility value of 31.61 at 25°C for coumaphoxon. Use of these values accounts for the difference in estimated EECs. Furthermore, Bayer Corporation recently provided preliminary results of data conducted on coumaphoxon that indicate that the Kocvalues for coumaphoxon are 1,897.78 and greater. Finally, the Agency has recently received information that suggests that most of the coumaphos residual resulting from dip use on livestock is collected and transported to concrete-lined evaporation pits thereby negating any potential for ground water contamination. The Agency is currently verifying these practices. For these reasons the revised EECs are still considered a very conservative exposure assessment.

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). Coumaphos 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. In applying the safety standard in section 408(b)(2)(A), EPA is required to consider, among other relevant factors, “available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity.” Coumaphos is in a family of pesticides known as organophosphates. As documented in EPA presentations to the FIFRA Scientific Advisory Panel, EPA has concluded that organophosphates share a common mechanism of toxicity and thus have a cumulative toxic effect (A Common Mechanism of Action: The Organophosphate Pesticides, 11/2/98, USEPA). Based on this conclusion EPA has been working toward preparing a cumulative risk assessment on the organophosphate pesticides, including coumaphos, as part of the tolerance reassessment program and has generally refused to register new uses of organophosphates under FIFRA or establish new tolerances for such pesticides under the FFDCA prior to completing this cumulative assessment. EPA has considered the potential cumulative effects of coumaphos. EPA has concluded the risks posed by granting this tolerance are so small that they are effectively indistinguishable from the overall aggregate risk of coumaphos, much less the overall cumulative risk posed by the organophosphates. The dire need for this use, combined with its infinitesimal risk, make it clear, that no matter what the result of any cumulative risk assessment for the organophosphates, it is very unlikely that this use would be proposed for revocation.

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

2.Developmental toxicity studies. The developmental toxicity studies in rats and rabbits showed no evidence of additional sensitivity to young rats or rabbits following prenatal or postnatal exposure to coumaphos and comparable NOAELs were established for adults and offspring.

In a developmental toxicity study pregnant rats received oral doses of coumaphos at 0, 1, 5 or 25 mg/kg/day during gestation days 6 through 15. For maternal toxicity, the NOAEL was 5 mg/kg/day and the LOAEL was 25 mg/kg/day based on clinical signs of cholinesterase inhibition. For developmentaltoxicity, the NOAEL was 25 mg/kg/day (HDT); a LOAEL was not established. There was no evidence of teratogenicity.

In a developmental toxicity study, pregnant rabbits were given single oral dose of coumaphos at 0, 0.25, 2, or 18 mg/kg/day during gestation days 7 through 19. For maternal toxicity, the NOAEL was 2 mg/kg/day and the LOAEL was 18 mg/kg/day based on mortality (2/17) and cholinergic signs. For developmental toxicity, the NOAEL was 18 mg/kg/day (HDT); a LOAEL was not established. There was no evidence of teratogenicity.

3.Reproductive toxicity study. In a 2-generation reproduction study, rats werefed diets containing coumaphos at 0, 0.07, 0.3, or 1.79 mg/kg/day in males and 0, 0.08, 0.34 or 2.02 mg/kg/day in females, respectively. There was no increased sensitivity to pups over the adults. For parental/systemic toxicity, the NOAEL was 1.79 mg/kg/day, (HDT); a LOAEL was not established. For reproductive toxicity, the NOAEL was 1.79 mg/kg/day; a LOAEL was not established.

4.Cholinesterase inhibition. Cholinesterase activity was not measured in the adults and offspring in the developmental toxicity studies. In the reproduction study, ChE activity was measured in adults and pups. There was dose-related decreases in plasma and red blood cell cholinesterase activity in dams at 0.34 and 2.02 mg/kg/day. Generally, no differences were seen on day 47 and day 91 measurements. Brain levels were biologically significantly inhibited in F0and F1adult females at 2.02 mg/kg/day, and in F0adult males at 1.79 mg/kg/day. In pups, no significant changes in red blood cell or brain cholinesterase activity were seen on day 4, but on day 21 changes were seen at 2.02 mg/kg/day. In F1pups, plasma and red blood cell ChE inhibition of 38-44%% was seen, while in F2pups, only plasma was affected (31-44%%). The only significant brain inhibition in pups was an 8%% decrease in F1females on day 21. The NOAEL was 0.3 for cholinesterase inhibition in dams and in pups on day 21.

5.Neurotoxicity. In an acute delayed neurotoxicity study, no delayed neurotoxicity was seen in hens given a single oral dose (via gelatin capsule) of coumaphos at 50 mg/kg. There are sufficient data available to adequately assess the potential for toxicity to young animals following prenatal and/or postnatal exposure to coumaphos. These include acceptable developmental toxicity studies in rats and rabbits, as well as, a 2-generation reproduction studies in rats. In addition, no treatment-related neuropathology was seen after acute and subchronic exposure to rats. Additionally, there was no evidence of abnormalities to the fetus to the fetal nervous system in the prenatal and postnatal studies.

6.Prenatal and postnatal sensitivity. Prenatal developmental toxicity studies in rats and rabbits provided no indication of increased susceptibility of rat or rabbit fetuses toin uteroexposure to coumaphos. There was no indication of increased susceptibility in the offspring as compared to parental animals in the 2-generation reproduction study. In these studies, effects in the fetuses/offspring were observed only at or above treatment levels which resulted in evidence of parental toxicity.

7.Conclusion. Previously for coumaphos, the Agency recommended the FQPA safety factor be reduced from 10x to 3x due to data gaps for the acute and subchronic neurotoxicity studies. These data requirements have been satisfied and therefore, the Agency has determined the FQPA safety factor can be reduced to 1x. The decision to reduce the FQPA Safety factor to 1x is based on the following:

The previous data gap for acute and subchronic neurotoxicity have been satisfied. There is no indication of increased susceptibility of rat or rabbits to coumaphos. In the developmental and reproduction toxicity studies, effects in the fetuses/offspring were observed only at or above treatment levels which resulted in evidence of parental toxicity.

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

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

When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to coumaphos 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 coumaphos on 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 coumaphos at the 99.9thpercentile will occupy 8%% of the aPAD for the U.S. population, 4%% of the aPAD for females 13 through 50 years old, 21%% of the aPAD for all infants less than 1 year old, the infant subpopulation at greatest exposure and 15%% of the aPAD for children 1-6 years old, the children subpopulation at greatest exposure. In addition, despite the potential for acute dietary exposure to coumaphos in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of coumaphos in surface and ground water. EPA does not expect the aggregate exposure to exceed 100%% of the aPAD.

Comparing the risk estimates for the addition of honey and beeswax to those discussed in the risk assessment recently released for public comment under Phase 5 of the reregistration process for the registered uses on livestock, the Agency concludes that there is no incremental increase in dietary exposure or risk when the residues in honey are added to those from the registered uses on livestock. The slight changes reported in some cases (e.g., increase in acute exposure for children 7-12 years old) are likely to be within the noise or uncertainty of the analyses. The fact that the calculated exposure actually decreases in a few cases when honey is added to livestock is further indication of this.

Within the operating capability of the model, the Agency concludes that the above results show there is no incremental increase in dietary exposure or risk when the residues in honey are added to those from the registered uses on livestock.

2.Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to coumaphos from food will utilize 6%% of the cPAD for the U.S. population, 4%% of the cPAD for all infants less than 1 year old, and 14 %% of the cPAD for children 1-6 years old, the children subpopulation at greatest exposure. There are no residential uses for coumaphos that result in chronic residential exposure to coumaphos. In addition, despite the potential for chronic dietary exposure to coumaphos in drinking water, after calculating the DWLOCs and comparing them to conservative model estimated environmental concentrations of coumaphos in surface and ground water. EPA does not expect the aggregate exposure to exceed 100%% of the cPAD.

Comparing the risk estimates for the addition of honey and beeswax to those discussed in the risk assessment recently released for public comment under Phase 5 of the reregistration process for the registered uses on livestock, the Agency concludes that there is no incremental increase in dietary exposure or risk when the residues in honey are added to those from the registered uses on livestock. The slight changes reported in some cases are likely to be within the noise or uncertainty of the analyses. The fact that the calculated exposure actually decreases in a few cases when honey is added to livestock is further indication of this.

Within the operating capability of the model, the Agency concludes that the above results show there is no incremental increase in dietary exposure or risk when the residues inhoney are added to those from the registered uses on livestock.

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

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

5.Aggregate cancer risk for U.S. population. Coumaphos isclassified as Group E (no evidence of carcinogenicity in humans).

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 coumaphos residues.

Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression. The method for honey is Bayer Method 150.803 and for beeswax is Bayer Method 150.804. Either method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no Codex tolerances for coumaphos, therefore there are no harmonization issues with this tolerance.

Therefore, the tolerances are established for combined residues of coumaphos, (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl) phosphate, in or on honey at 0.1 ppm and beeswax at 100 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-301039 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 October 16, 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 judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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

3.Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by the docket control number OPP-301039, 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 notinclude any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes time limited tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory 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. 3501et 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, entitledConsultation and Coordination with Indian Tribal Governments(63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitledFederal 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, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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, entitledFederalism(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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected 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 underFOR FURTHER INFORMATION CONTACT.

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

2.In person. The Agency has established an official record for this action under docket control number OPP-301029. 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.

EPA, on its own initiative, in accordance with sections 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for residues of phosphine resulting from the use of the rodenticide zinc phosphide in or on barley and wheat grain, wheat hay and aspirated grain fractions at 0.010 parts per million (ppm), barley hay at 0.20 ppm, and barley straw at 0.020 ppm. These tolerances will expire and are revoked on December 31, 2001. EPA will publish a document in theFederal Registerto remove the revoked tolerances from the Code of Federal Regulations.

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

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

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

EPA has authorized under FIFRA section 18 the use of zinc phosphide on barley and wheat for control of meadow voles and field mice in Idaho. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of zinc phosphide in or on barley and wheat grain, hay and straw and wheat aspirated grain fractions. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would beconsistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6). Although this tolerance will expire and is revoked on December 31, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on barley and wheat grain, hay and straw and wheat aspirated grain fractions after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether zinc phosphide meets EPA's registration requirements for use on barley and wheat or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of zinc phosphide by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Idaho to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for zinc phosphide, contact the Agency's Registration Division at the address provided underFOR FURTHER INFORMATION CONTACT.

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of zinc phosphide and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for residues of phosphine resulting from the use of the rodenticide zinc phosphide in or on barley and wheat grain, wheat hay and aspirated grain fractions at 0.010 ppm, barley hay at 0.20 ppm, and barley straw at 0.020 part per million (ppm). EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follow.

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 zinc phosphide are discussed in this unit.

1.Acute toxicity. No toxicology studies were identified by EPA which demonstrated the need for an acute dietary risk assessment.

2.Short- and intermediate-term toxicity. Based on the acute dermal LD50study in rabbits, no appropriate toxic effects were identified for risk assessment. In that study no mortalities were observed at 5,000 milligrams/kilograms (mg/kg). At the lowest observed adverse effect level (LOAEL) of 2,000 mg/kg, there was a decrease in body weight. Based on the physical properties of the chemical, dermal absorption is expected to be very low, since zinc phosphide reacts with water and stomach acid to produce the toxic gas phosphine from oral, but not dermal, exposure. As no endpoint of toxicological concern for dermal exposure has been identified, no dermal penetration data were required. The requirement for an acute inhalation study has been waived, thus, zinc phosphide has been placed in Toxicity Category I for acute inhalation exposure.

3.Chronic toxicity. EPA has established the Reference Dose (RfD) for zinc phosphide at 0.0001 mg/kg/day. This RfD is based on a subchronic oral study in rats with a no observed adverse effect level (NOAEL) of 0.1 mg/kg/day and an uncertainty factor of 1,000 based on increased mortality, increase in absolute and relative liver weight and hematological changes at the LOAEL of 1 mg/kg/day. An uncertainty factor of 100 was applied to account for both the interspecies extrapolation and intraspecies variability. An additional UF of 10 was applied to account for the lack of reproductive data, and the lack of chronic toxicity data in a non-rodent species.

4.Carcinogenicity. Zinc phosphide has not been classified as to its carcinogenic potential since cancer studies have been waived. Although this chemical has food uses, dietary exposure is expected to be minimal.

1.From food and feed uses. Tolerances have been established (40 CFR 180.284) for the residues of phosphine resulting from the use of zinc phosphide, in or on a variety of raw agricultural commodities at levels ranging from 0.01 ppm in or on grapes to 0.1 ppm in or on grasses (rangeland). There is no reasonable expectation of secondary residues in meat, milk, poultry or eggs. Any residues of zinc phosphide ingested by livestock would be metabolized to naturally occurring phosphorous compounds. Risk assessments were conducted by EPA to assess dietary exposures and risks from zinc phosphide as follows:

Acute and chronic exposure and risk. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In our best scientific judgment, the proposed use of zinc phosphide on wheat and barley will not result in acute or chronic human dietary exposure to zinc phosphide due to the following:

Zinc phosphide is not systemic.

Applications are made prior to the grain head formation.

Residue data show that residues of phosphine are less than the limit of quantification (0.010 ppm) in wheat and barley grain.

The grain will be highly processed prior to human consumption.

There is no expectation of secondary residues in meat, milk, poultry, and eggs as a result of the registered and proposed uses.

2.From drinking water.Zinc phosphide degrades rapidly to phosphine (PH3) and zinc ions (Zn2+), both of which adsorb strongly to soil and are common nutrients in soil. Zinc phosphide and its degradation products appear to have low potential for ground and surface water contamination. Therefore, dietary exposure is not expected from either ground or surface water fed drinking water.

3.From non-dietary exposure. Zinc phosphide is currently registered for use on residential non-food sites. A detailed residential exposure assessment is contained in the RED for zinc phosphide (RED Zinc Phosphide, EPA 738-R-98-006, July 1998). The residential exposure assessment evaluated exposure from accidental ingestion of zinc phosphide. No other residential exposure assessment was required. It is stated in the RED that the Agency believes that “accidental ingestion” of zinc phosphide baits should not be included in the FQPA determination for tolerance setting.

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.” Zinc phosphide, aluminum phosphide and magnesium phosphide all generate phosphine gas.

EPA does not have, at this time, available data to determine whether zinc phosphide 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, zinc phosphide 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 zinc phosphide has a common mechanism of toxicity with other substances. For more 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.Acute and chronic risk. There is no drinking water, residential, nor dietary component to acute and chronic aggregate exposure to zinc phosphide residues. Thus, acute and chronic aggregate exposure assessments are not required.

2.Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account chronic dietary food and water (considered to be a background exposure level) plus indoor and outdoor residential exposure. No short- or intermediate-term dermal, oral or inhalation toxicological endpoints were identified for zinc phosphide. Thus, no short- or intermediate-term risk assessments are required.

3.Aggregate cancer risk for U.S. population. Although zinc phosphide is registered for use on food crops, no chronic toxicity or carcinogenicity studies were required because chronic exposure to zinc phosphide or its byproducts were considered to be negligible. Thus, data are not available to classify zinc phosphide in terms of carcinogenicity and a cancer risk assessment was not performed.

4.Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to zinc phosphide residues.

1.Acute and chronic risk. There is no drinking water, residential, nor dietary component to acute and chronic aggregate exposure to zinc phosphide residues. Thus, acute and chronic aggregate exposure assessments are not required.

2.Short- or intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account chronic dietary food and water (considered to be a background exposure level) plus indoor and outdoor residential exposure. No short- or intermediate-term dermal, oral or inhalation toxicological endpoints were identified for zinc phosphide. Thus, no short- or intermediate-term risk assessments are required.

3.Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to zinc phosphide residues.

The nature of the residue in plants is adequately understood. The residue of concern is zinc phosphide measured as phosphine.

There is no expectation of secondary residues in meat, milk, poultry, and eggs as a result of the registered uses. Residues of zinc phosphide ingested by livestock would be immediately converted to phosphine and metabolized to naturally occurring phosphorous compounds.

Adequate enforcement methodology (colorimetric and GLC/FPD) is available (Pesticide Analytical Method II under aluminum phosphide) to enforce the tolerance expression.

Residues of phosphine resulting from the use of zinc phosphide are not expected to exceed 0.010 ppm in/on barley grain and wheat grain, 0.20 ppm in barley hay, 0.020 ppm in barley straw, 0.010 ppm in wheat hay, 0.010 ppm in wheat straw, 0.010 ppm in aspirated grain fractions under the use conditions of this section 18 exemption.

No CODEX, Canadian or Mexican Maximum Residue Levels have been established for zinc phosphide.

Data for confined accumulation in rotational crops has been waived because the physical properties of zinc phosphide precludes transfer of residues to rotated crops (Zinc Phosphide RED, EPA 738-R-98-006, July 1998). Thus, rotational crop restrictions are not required.

Therefore, tolerances are established for residues of phosphine resulting from the use of the rodenticide zinc phosphide in or on barley and wheat grain, wheat hay and aspirated grain fractions at 0.010 ppm, barley hay at 0.20 ppm, and barley straw at 0.020 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-301029 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 October 16, 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 judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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

3.Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by the docket control number OPP-301029, 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 time-limited tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory 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. 3501et 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, entitledConsultation and Coordination with Indian Tribal Governments(63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitledFederal 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, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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, entitledFederalism(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 variouslevels 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

On June 30, 2000, the Commission adopted in theTribal Order, 65 FR 47883 (August 4, 2000), measures to promote telecommunications subscribership and infrastructure deployment within American Indian and Alaska Native tribal communities; to establish a framework for the resolution of eligible telecommunications carrier designation requests under section 214(e)(6) of the Telecom Act; and to apply the framework to pending petitions for designation as eligible telecommunications carriers. A summary was published in theFederal Register. See 65 FR 47883, August 4, 2000. Some of the rules contained information collection requirements. We stated that the “rules contain information collection requirements that have not been approved by the Office of Management and Budget (OMB). The Commission will publish a document in theFederal Registerannouncing the effective date of these sections.” The information collections were approved by OMB on July 31, 2000. See OMB Nos. 3060-0774 and 3060-0810. This publication satisfies our statement that the Commission would publish a document announcing the effective date of the rules. It also amends the Commission's universal service rules to provide additional, targeted support under the Commission's low-income programs to create financial incentives for eligible telecommunications carriers to serve, and deploy telecommunications facilities in, areas that previously may have been regarded as high risk and unprofitable.

The final regulations to implement the HMS FMP and Amendment 1 to the Atlantic Billfish Fishery Management Plan (64 FR 29090, May 28, 1999) included a provision requiring an owner or operator of a commercial vessel permitted to fish for Atlantic HMS under § 635.4 and that fishes with a pelagic longline to install a NMFS-approved VMS unit on board the vessel and operate the VMS unit whenever the vessel leaves port with pelagic longline gear on board. The VMS requirement of the final rule (§ 635.69) was to be effective September 1, 1999.

On August 9, 1999, NMFS delayed the effective date of this final rule until January 1, 2000 (64 FR 43101). On October 14, 1999, NMFS again delayed the effective date of this final rule until June 1, 2000 (64 FR 55633). On April 19, 2000, NMFS further delayed the effective date of implementation of the VMS regulations until September 1, 2000 (65 FR 20918).

On August 1, 2000, NMFS published a final rule (65 FR 47214) to reduce bycatch by prohibiting the use of pelagic longline fishing gear in three areas: the year-round DeSoto Canyon closure in the Gulf of Mexico starting November 1, 2000; the year round East Florida Coast closure beginning on February 1, 2001; and the seasonal Charleston Bump closure from February 1 through April 30 each year, beginning in 2001.

Since publication of the final rule implementing the time area closures, NMFS has received several requests for an additional delay of the VMS requirement until the effective dates of the new closed areas (November 1, 2000 in the Gulf of Mexico and February 1, 2001 in the Atlantic Ocean). These requests included the information that many vessels have not yet purchased VMS units, as vessel owners have been waiting for the resolution of litigation against NOAA Fisheries over the regulatory requirement for these devices.

Because the regulations implementing the new time area closures will not require the use of VMS for enforcement purposes until November 1, 2000 (the initial effective date of the DeSoto Canyon closed area), NMFS agrees that a short delay in the VMS requirement will not compromise NMFS' ability to enforce the fishery closures. An October 1, 2000, effective date would give an additional month for vessel owners to acquire and install the units. Although the designated Atlantic Ocean closed areas are not effective until February 1, 2001, requiring all vessels using pelagic longlines to operate VMS units in all fishing areas as of October 1, 2000 will facilitate tracking and monitoring of vessels as they begin to modify fishing practices in response to the bycatch reduction strategy.

NMFS thus delays the effective date of the VMS regulations at 50 CFR 635.69 until October 1, 2000.

The Northeast Multispecies regulations, at 50 CFR 648.80(a)(7)(i)(A), specify that in order for any fishery to occur in the GOM/GB Regulated Mesh Area, it must be shown to have a bycatch of regulated multispecies that is less than 5 percent of the catch of all species. This regulation is intended to prevent the bycatch and discard of large amounts of regulated multispecies that could be caught in fisheries targeting other species. Small mesh bottom trawl fisheries are of particular concern because of the interactions of bottom fish, the limited selectivity of small mesh, and the high potential of regulated multispecies bycatch. However, to provide for the ability to conduct fisheries that have a bycatch of regulated multispecies that is low, the Northeast Multispecies regulations allow fisheries to occur if they can be proven to have less than 5 percent bycatch of regulated multispecies.

In 1995, the Massachusetts Division of Marine Fisheries (MADMF) began testing the raised footrope trawl design with a single Provincetown otter trawl vessel in a small area in Cape Cod Bay to determine whether modified whiting trawl gear would sufficiently reduce bycatch of regulated multispecies. A raised footrope trawl was designed so that the mouth of the net fished above the ocean floor, thereby reducing bycatch of flatfish, lobster, and other bottom dwelling species while still catching species that remain above theocean floor, such as whiting. After developing a gear that successfully reduced bycatch of flatfish and caught whiting undamaged by bottom debris and hard-bodied, bottom dwelling species, the MADMF proceeded with an expansion of the fishery in 1996. From 1996 through 1999, the fishery was expanded to a maximum of 43 vessels. Expansion of the fishery allowed the MADMF to evaluate the effectiveness of the modified gear when used by a relatively large number of vessels. Enforceability of the gear requirements, fishermen's willingness to change gear specifications, and ease of adapting to and using the new gear were examined. In addition, expansion of the fishery provided the ability for the MADMF to collect significant amounts of data through observed fishing trips and vessel trip reports. Expansion to additional areas was also authorized by NMFS through experimental fisheries.

In the fall of 1999, the MADMF requested that NMFS exempt the fishery based on the low bycatch rates of regulated multispecies, particularly flatfish. In order to meet the qualifications for an exempted fishery under the FMP, data collected from the experimental fishery must demonstrate that the fishery results in bycatch of regulated multispecies that is less than 5 percent, by weight, of the total catch and that such exemption will not jeopardize fishing mortality objectives (50 CFR 648.80(a)(7)(i)(A)). NMFS takes a conservative approach in applying the 5 percent criteria by requiring that it be met on a trip-by-trip basis as recommended by the New England Fishery Management Council (Council). NMFS informed the MADMF that because of the trip-by-trip requirement the fishery did not qualify for an exemption.

Recognizing the success of the gear in dramatically reducing bycatch, the Council, at its January 18, 2000, meeting, initiated Framework 35 to establish the raised footrope trawl exempted small mesh whiting fishery based on the significant reductions of bycatch of regulated species encountered in the fishery.

While the fishery has not met the trip-by-trip bycatch reductions, the overall reduction of regulated multispecies bycatch has been significant with the raised footrope trawl gear compared to landings and bycatch of regulated multispecies in regulated multispecies directed fisheries. The overall percentage of raised footrope trawl discards in 1999 compared to January through November 1999, landings in the directed regulated multispecies fisheries ranged from 2.2 percent (GOM winter flounder) to less than 0.01 percent. GOM cod bycatch in the 1999 raised footrope trawl fishery represented approximately 0.93 percent of the landings of cod in the directed regulated multispecies fishery from January through November 1999. In addition, bycatch of regulated multispecies in the 1999 raised footrope trawl fishery represented a relatively low percentage of overall regulated multispecies discards, ranging from 0.02 percent for witch flounder to 5.95 percent for GOM cod. Also, the raised footrope trawl has demonstrated significant overall reductions in bycatch compared to traditional whiting trawl gear. In the area near Provincetown in 1997, for example, regulated flatfish bycatch with traditional whiting nets was approximately 66 lb (29.9 kg) per hour. With the raised footrope trawl, the bycatch rate was approximately 7 lb (3.18 kg) per hour—a reduction of approximately 89 percent. Results in 1998 and 1999 were similar. Since bycatch of cod and other roundfish was known to be a continued problem with the modified gear, the MADMF prosecuted the fishery in areas low in cod and other roundfish concentrations.

During October and November, the area encompassed by this exempted fishery falls almost entirely within the October/November GOM rolling closure area (Rolling Closure V). Framework 35 allows the exempted fishery to operate within the closed area under a letter of authorization. Operation of this fishery in the closed area should not pose a threat to flatfish, but could pose a threat to cod if high concentrations are present. However, cod bycatch is not expected to be significant. First, the season for this exempted fishery is September 1 through November 20. Historically, cod bycatch in the experimental raised footrope trawl fishery increased in November and cod bycatch after November 20 has represented 50 percent of the bycatch of cod for the entire experimental fishing season (September through December). Second, during the development of Framework 33 to the FMP, the Northeast Fishery Science Center (NEFSC) provided evidence that cod concentrations in the southern portion of block 124 (the portion of the closed area overlapped by the exempted area) is low. Cod concentrations appear to be approximately five times higher in the northwestern and west-central parts of block 124 (areas not overlapped by the proposed exempted fishery area), in the autumn, based on NEFSC trawl survey data from 1994 through 1998. Further, the use of exempted fishery authorization letters will allow NMFS to identify vessels participating in the fishery on a day-to-day basis, providing the ability for simplified monitoring of the fishery.

Framework 35 establishes the exempted whiting raised footrope trawl fishery in an area in upper Cape Cod Bay. The exempted area is a modification of the areas authorized for previous experimental fisheries, but falls completely within the areas studied under the experiment. The exempted area is based on the highest concentrations of observed and reported fishing activity during the experimental fisheries.

Requirements of the exempted fishery include gear specifications for the raised footrope trawl and bycatch restrictions. Gear restrictions include: minimum mesh size; prohibition on net strengtheners; headrope specifications including number and distribution of floats; ground gear (legs) specifications; footrope specifications; drop chain specifications (with an option for a sweepless net configuration); and chain-sweep specifications. Because Small Mesh Areas 1 and 2 in the GOM (already exempted fisheries) require the use of a raised footrope trawl, these specifications also apply in those areas, with the exception of the minimum mesh size and prohibition on net strengthener use. The only modifications to the current gear requirements in Small Mesh Areas 1 and 2 is an option to use a sweepless raised footrope trawl net and a change of the footrope length specification. The change to the footrope length is implemented through this framework to correct the regulations which mistakenly stated that the footrope must be at least 20 ft (6.1 m) longer than the headrope. To be consistent with the original design of the MADMF's net, the footrope must be no greater than 20 ft (6.1 m) longer than the headrope. Modifying the mesh size and strengthener requirements in Small Mesh Areas 1 and 2 is outside the scope of this framework.

While enrolled in the raised footrope trawl whiting fishery, vessels are restricted to retaining only the following species: Whiting, offshore hake, red hake, butterfish, dogfish, herring, mackerel, scup, and squid, up to the amounts allowed by the regulations for each species. Retention of all other species is prohibited. Vessels fishing in the raised footrope trawl fishery may fish in other small mesh fisheries, but are subject to the most restrictive measures, regardless of where they are fishing.

The economic impacts of exempting the raised footrope trawl whiting fishery were analyzed in the RIR section of the Council's framework document and the supplement to that document. When compared to taking no action, implementation of the exempted fishery under Framework 35 is likely to generate approximately $1.25 million in revenues for vessels fishing primarily out of the ports of Gloucester and Provincetown, MA, based on 1997 through 1999 averages. Existing area closures, gear restrictions, and fishing effort controls would otherwise limit the potential participants. Other alternatives, such as gear modifications and additional areas, were considered throughout the development of the fishery and during the experimental fishery phase. However, the gear specifications included in this framework maximize flexibility of the industry while minimizing bycatch. Exemption in additional areas is not warranted due to insufficient information to determine bycatch levels. Framework 35 also results in minor modifications to the gear specifications in Small Mesh Areas 1 and 2. These modifications are expected to result in minimal costs to vessels. Vessels that fish in Small Mesh Areas 1 and 2 are already required to use raised footrope trawl gear and only minimal costs would be required to modify their existing gear, if any modifications need to be made at all.

NMFS is making these adjustments to the regulations under the framework abbreviated rulemaking procedure in 50 CFR part 648, subpart F. This procedure requires the Council, when making specifically allowed adjustments to the FMP, to develop and analyze the action over the span of at least two Council meetings where public comments are accepted. The Council must provide the public with advance notice of both the framework proposals and the associated analyses, and provide an opportunity to comment on them specifically prior to and at the second Council meeting. Upon review of the analyses and public comments, the Council may recommend to the Regional Administrator, Northeast Region (Regional Administrator), that the measures be published as a final rule, or as a proposed rule if additional public comment is necessary.

The initial and final meetings for Framework 35 at which public comment was received were on January 18, 2000, and May 3, 2000, respectively. The Council also discussed the raised footrope whiting exempted fishery at previous meetings on other actions, including the Council meeting on November 16 through 19, 1999, the Council's Groundfish Committee on December 13, 1999, and January 14, 2000, and at the Groundfish Committee Advisory Panel meetings on December 13, 1999, and January 13, 2000. Documents summarizing the Council's proposed action and the analyses of biological, economic, and social impacts of this action and alternative actions were available for public review 1 week prior to the final meeting, as is required under the framework adjustment process. No written comments were received.

This final rule has been determined to be not significant for the purposes of E.O. 12866.

Notwithstanding any other provisions of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act (PRA), unless that collection of information displays a currently valid OMB control number.

This final rule contains collection-of-information requirements subject to the PRA. These requirements have been approved by OMB. The OMB Control numbers and estimated response times are as follows:

1. Call-in to NMFS Region for enrollment into Raised Footrope Trawl Exempted Whiting Fishery (§ 648.80(a)(14)(i)(A)) approved under 0648-0422 at 2 minutes/response.

2. Call-in to NMFS Region to withdraw from the Raised Footrope Trawl Exempted Whiting Fishery (§ 648.80(a)(14)(i)(A)) approved under 0648-0422 at 2 minutes/response.

The estimated response times include the time needed for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these burden estimates or any other aspect of the data requirements, including suggestions for reducing the burden, to NMFS and OMB (seeADDRESSES).

Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553et seq., or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601et seq., are inapplicable. Nevertheless, the socioeconomic impacts on affected small entities were considered in the EA/RIR contained in the supporting analyses for Framework 35 and the supplement to Framework 35. The economic impacts are described in theSUPPLEMENTARY INFORMATIONsection of the preamble to this final rule.

The Assistant Administrator for Fisheries, NOAA (AA), finds that, because public meetings held by the Council to discuss the management measures implemented by this final rule provided adequate prior notice and opportunity for public comment, further notice and opportunity to comment on this final rule is unnecessary. Therefore, the AA, under 5 U.S.C. 553(b)(B), finds good cause exists to waive prior notice and additional opportunity for public comment.

This final rule establishes an exempted small mesh whiting fishery in the Gulf of Maine and vessel operators who choose to participate in this fishery would be required to use a raised footrope trawl gear. Existing area closures, gear restrictions, and fishing effort controls would otherwise limit vessel operators from fishing for whiting in this area. Therefore, this action relieves a restriction, under 5 U.S.C. 553(d)(1) and is not subject to a 30-day delay in effectiveness. This final rule also results in minor modifications to the gear specifications in Small Mesh Areas 1 and 2. Vessels that fish in these areas are already required to use raised footrope trawl gear. The minor modifications made by this rule will provide vessels with an option to use sweepless raised footrope trawl net and will clarify that the footrope may not be more than 20 ft longer than the headrope. By providing another gear option, this rule does not impose a restriction. Furthermore, complying with the clarified requirement that the footrope be no more than 20 ft longer than the headrope will require only a minimal amount of time. In addition, participation in the raised footrope trawl gear fishery is voluntary and vessel operators can choose whether or not to modify their gear, if necessary, to participate in this fishery. Therefore, it is not necessary to delay for 30 days implementation of the gear modification provisions associated with this final rule.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The Pacific halibut bycatch allowance for the GOA trawl shallow-water species fishery, which is defined at § 679.21(d)(3)(iii)(A), was established by the Final 2000 Harvest Specifications for Groundfish for the GOA (65 FR 8298, February 18, 2000) for the third season, the period July 4, 2000, through September 30, 2000, as 200 metric tons.

In accordance with § 679.21(d)(7)(i), the Administrator, Alaska Region, NMFS, has determined that the third seasonal apportionment of the 2000 Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery in the GOA has been caught. Consequently, NMFS is prohibiting directed fishing for species included in the shallow-water species fishery by vessels using trawl gear in the GOA, except for vessels fishing for pollock using pelagic trawl gear in those portions of the GOA open to directed fishing for pollock. The species and species groups that comprise the shallow-water species fishery are: pollock, Pacific cod, shallow-water flatfish, flathead sole, Atka mackerel, and “other species.”

Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).

This action responds to the best available information recently obtained from the fishery. It must be implemented immediately in order to prevent exceeding the third seasonal apportionment of the 2000 Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery in the GOA. A delay in the effective date is impracticable and contrary to thepublic interest. NMFS finds for good cause that the implementation of this action can not be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is required by § 679.21 and is exempt from review under Executive Order 12866.