Section 331 of the fiscal year 1998 Department of the Interior and Related Agencies Appropriations Act (Pub. L. 105-83; November 14, 1997) and Section 330 of the fiscal year 2001 Department of the Interior and Related Agencies Appropriations Act (Pub. L. 106-291; October 11, 2000) authorize the Secretaries of Agriculture and the Interior to make reciprocal delegations of their respective authorities, responsibilities, and duties in support of the “Service First” initiative to promote customer service and efficiency in the management of public lands and National Forest System lands.

In the initial implementation of the “Service First” initiative, the Secretary of Agriculture delegated authority to establish “Service First” pilots and to make reciprocal delegations to Bureau of Land Management (BLM) officials to the Chief of the Forest Service through Secretary's Memorandums, which are part of USDA's internal directive system. Further delegations from the Chief to lower-level Forest Service officials, as necessary to carry out the goals of joint pilot projects, were made through Interim Directive No. 1230-2001-1 to Chapter 1230—Delegations of Authority and Responsibility, of the Forest Service Manual (36 CFR 200.4).

Congress has now authorized establishment of pilot projects across the agency through fiscal year 2005 (Pub. L. 106-291). Accordingly, it is more efficient to provide for a continuing delegation of authority to the Chief through issuance of a rule to Title 7, Code of Federal Regulations, Part 2—Delegations of Authority by the Secretary of Agriculture and General Officers of the Department. Therefore, this final rule amends 7 CFR 2.20 and 2.60 to delegate authority from the Secretary of Agriculture to the Under Secretary for Natural Resources and Environment and to further delegate authority to the Chief of the Forest Service to enter into pilot projects with BLM and to delegate to BLM employees the authority to perform FS duties. Should Congress extend the pilot project authority beyond September 30, 2005, make the Service First authority a continuing authority, or decide not to renew the authority, the Department will revise 7 CFR 2.20 and 2.60 as needed to conform to future legislative action.

This rule relates solely to internal agency management. Therefore, pursuant to 5 U.S.C 553, notice of a proposed rulemaking and opportunity to comment are not required. For this same reason, this rule is also exempt from the provisions of Executive Order No. 12866 on Federal Regulations and Executive Order No. 12988 on Civil Justice Reform. In addition, this action is not a rule as defined by the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. and, thus, is exempt from the provisions of that Act. Accordingly, as authorized by section 808 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, this rule may be made effective immediately upon publication in the Federal Register .

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of specified animals and animal products into the United States in order to prevent the introduction of various animal diseases. The regulations in § 94.6 govern, among other things, the importation of poultry carcasses, parts or products of poultry carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from regions where exotic Newcastle disease (END) is considered to exist. END is considered to exist in all regions not listed in § 94.6(a)(2).

END is a contagious and fatal viral disease affecting all species of birds. Previously known as velogenic viscerotropic Newcastle disease, END is considered one of the most infectious diseases of poultry in the world. The disease is so virulent that some birds die without exhibiting any symptoms, and a death rate of nearly 100 percent can occur in unvaccinated flocks. END can also infect and kill vaccinated poultry.

The disease is spread primarily through direct contact between healthy birds and the bodily discharges, including droppings and secretions from the nose, mouth, and eyes of infected birds. END incubation ranges from 2 to 15 days, and infected birds may present a variety of respiratory and digestive symptoms before they die. Egg production may decrease or cease entirely.

Under § 94.6, poultry carcasses, and parts and products of poultry carcasses may be imported into the United States from regions where END exists only if they have been cooked or are consigned directly to an approved establishment in the United States. Eggs (other than hatching eggs) of poultry, game birds, or other birds from regions where END exists may be imported into the United States only if: (1) They are accompanied by a health certificate regarding the flock of origin and meet certain other conditions; (2) they are consigned directly to an approved establishment for breaking and pasteurization; (3) they are imported under permit for scientific, educational, or research purposes; or (4) they are imported under permit and have been cooked or processed and will be handled in a manner that prevents the introduction of END into the United States.

Further, poultry carcasses, parts or products of poultry carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds that do not qualify for entry into the United States under one of these conditions may transit the United States via air and sea ports under the conditions set out in § 94.15(d).

On July 16, 2002, Denmark reported a confirmed case of END to the Office International des Epizooties. Therefore, in order to prevent the introduction of END into the United States, we are amending § 94.6(a)(2) by removing Denmark from the list of regions considered to be free of END. This action restricts the importation of poultry carcasses, parts or products of poultry carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from Denmark. We are making this amendment effective retroactively to July 16, 2002, which is the date that END was confirmed in that region.

Although we are removing Denmark from the list of regions considered free of END, we recognize that Denmark immediately responded to the outbreak of END by imposing restrictions on the movement of poultry and poultry products within its borders and initiating measures to eradicate the disease. At this time, it appears that the outbreak is well-controlled. Considering Denmark's efficient response to the outbreak, we intend to reassess their END status at a future date. During the reassessment, we will consider all comments we receive on this interim rule, and the future assessment will determine whether it is necessary to continue to restrict the importation of poultry and poultry products from Denmark, whether we can restore Denmark to the list of regions considered free of END, or whether we can restore portions of Denmark as free of END.

This rulemaking is necessary on an emergency basis to prevent the introduction of END into the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule ( see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

We are amending the regulations by removing Denmark from the list of regions considered free of END. We are taking this action because Denmark has confirmed an outbreak of END. This action restricts the importation of poultry carcasses, parts or products of poultry carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from Denmark. This action is necessary to help prevent the introduction of END into the United States.

The Regulatory Flexibility Act requires that agencies consider the economic effects of their rules on small entities. Given that the U.S. does not currently import any poultry or poultry products from Denmark, we anticipate no U.S. entities, large or small, will experience any economic effects as a result of this rule.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection and Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has retroactive effect to July 16, 2002; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This interim rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Direction Generale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, recently notified FAA that an unsafe condition may exist on all Socata Model TBM 700 airplanes. The DGAC reports that, during a ground test of the flight control system on one of the affected airplanes, the pilot control wheel became jammed when performing dual actions ( e.g. , full up and full left) because the control wheel was turned beyond normal roll control travel limits. This was a result of a misadjustment of the roll control.

If this condition is not corrected, it could result in the flight control wheels traveling beyond normal roll control limits, which could result in the control wheel becoming jammed. This could lead to reduced or loss of control of the airplane.

We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all Socata Model TBM 700 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on July 12, 2002 (67 FR 46130). The NPRM proposed to require you to inspect the flight control system to determine if jamming occurs and adjust the roll control stop to correct this condition.

The DGAC AD requires inspection and, if necessary, adjustment prior to further flight after the effective date of the AD. We require that you inspect and, if necessary, adjust within 100 hours time-in-service (TIS) after the effective date of this AD.

We do not have justification to require this action prior to further flight. We use compliance times such as this when we have identified an urgent safety of flight situation. We believe that 100 hours TIS will give the owners or operators of the affected airplanes enough time to have the actions required by this AD accomplished without compromising the safety of the airplanes.

The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.

After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:

We estimate that this AD affects 133 airplanes in the U.S. registry.

We estimate the following costs to accomplish the inspection:

We estimate the following costs to accomplish any necessary modification that will be required based on the results of the inspection. We have no way of determining the number of airplanes that may need such modification:

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

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

On August 16, 2002, the FAA issued emergency AD 2002-17-53, applicable to Textron Lycoming LTIO-540 and TIO-540 series engines, rated at 300 HP or higher, to supersede emergency AD 2002-04-51 issued on February 11, 2002. AD 2002-17-53 requires replacing certain crankshafts that were manufactured using a hammer-forged process with crankshafts that were manufactured using a press-forged process. That action was prompted by reports of 17 crankshaft failures in LTIO-540 and TIO-540 engines, rated at 300 HP or higher, which were assembled with certain crankshafts that were manufactured using a hammer-forged process. The FAA is continuing the investigation into the cause of the crankshaft failures, and further regulatory action may follow. This action is prompted by an additional crankshaft failure that was outside the population of crankshafts covered by AD 2002-17-53. This AD requires the same replacement of certain crankshafts before further flight, and includes material testing of certain crankshafts manufactured between March 1997 and the present. This AD also expands the applicability to include all IO-540 engines with crankshafts that were manufactured between March 1997 and the present that have been modified by STC by installing a turbocharger system. This condition, if not corrected, could result in crankshaft failure, which could result in total engine power loss, in-flight engine failure and possible forced landing.

The FAA has reviewed the technical contents of Lycoming Mandatory Service Bulletin (MSB) No. 552, dated August 16, 2002, that provide tables of the affected engine and crankshaft serial numbers (SN's).

Since an unsafe condition has been identified that is likely to exist or develop on other Textron Lycoming LTIO-540 and TIO-540 engines, rated at 300 HP or higher, and on IO-540 engines that have been modified by STC by installing a turbocharger system with certain crankshafts installed, this AD requires removal of certain crankshafts before further flight and material testing of certain other crankshafts.

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 on August 16, 2002, to all known U.S. owners and operators of Textron Lycoming LTIO-540 and TIO-540 engines, rated at 300 HP or higher. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to Section 39.13 of part 39 of the Federal Aviation Regulations (14 CFR part 39) to make it effective to all persons.

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 caption ADDRESSES. 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 comments submitted in response to this notice must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2002-NE-03-AD.” The postcard will be date stamped and returned to the commenter.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and 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 caption ADDRESSES.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description on each SIAP is contained in the appropriate FAA Form 8260 and the National Flight Data Center (FDC)/Permanent (P) Notices to Airmen (NOTAM) which are incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation's Regulations (FAR). Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory test of the SIAPs, but refer to their graphic depiction of charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the afftected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes SIAPs. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained in the context of the following FDC/P NOTAMs for each SIAP. The SIAP information in some previously designated FDC/Temporary (FDC/.T) NOTAMs is of such duration as to be permanent. With conversion to FDC/P NOTAMs, the respective FDC/T NOTAMS have been canceled.

The FDC/P NOTAMs for the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these chart changes to SIAPs by FDC/P NOTAMs, the TERPS criteria were applied to only these specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a National Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Further, the SIAPs contained in this amendment are based on the criteria contained in the TERPS. Because of the clone and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequently and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, part 97 of the Federal Aviation Regulations (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows:

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, and 8260-5. Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. Some SIAP amendments may have been previously issued by the FAA in a National Flight Data Center (NFDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP amendments may require making them effective in less than 30 days. For the remaining SIAPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, part 97 of the Federal Aviation Regulations (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows:

Pursuant to the provisions of the 1970 UNESCO Convention, codified into U. S. law as the Convention on Cultural Property Implementation Act (Pub. L. 97-446, 19 U.S.C. 2601 et seq ) (the Act), the United States entered into a bilateral agreement with Mali on September 19, 1997 (Agreement Between the United States of America and the Government of the Republic of Mali Concerning the Imposition of Import Restrictions on Archaeological Material from the Region of the Niger River Valley and the Bandiagara Escarpment (Cliff)) (the Agreement), concerning the imposition of import restrictions on certain archaeological material from Mali. The U.S. Customs Service issued T.D. 97-80 (62 FR 49594, September 23, 1997) amending § 12.104g(a) of the Customs Regulations (19 CFR 12.104g(a)) to reflect the imposition of these restrictions for a period not to exceed five years. The restrictions became effective on September 23, 1997.

Prior to the issuance of T.D. 97-80, Customs issued T.D. 93-74 (58 FR 49428, September 23, 1993) that imposed emergency import restrictions on certain archaeological material from the region of the Niger River Valley in Mali and the Bandiagara Escarpment (Cliff) in Mali forming part of the remains of the ancient sub-Sahara culture. Under T.D. 93-74, § 12.104g(b) (19 CFR 12.104g(b)) of the regulations pertaining to emergency restrictions was amended accordingly. Subsequently, the same archaeological material covered by T.D. 93-74 was covered in T.D. 97-80 when it was published in 1997, at which time the emergency restrictions of T.D. 93-74 were removed from § 12.104g(b).

On August 19, 2002, the Assistant Secretary of Educational and Cultural Affairs, Department of State, concluded, among other things, that the cultural patrimony of Mali continues to be in jeopardy from pillage of irreplaceable materials representing its heritage and made the necessary determinations under 19 U.S.C. 2602(e) and 2602(a) to extend the import restrictions for a period not to exceed five years (in the Determination to Extend the Agreement). The Government of the United States and the Government of the Republic of Mali exchanged diplomatic notes on September 17, 2002, agreeing to extend the Agreement effective September 19, 2002. Accordingly, Customs is amending § 12.104g(a) to reflect the extension of the import restrictions.

The Designated List of Archaeological Material from the Region of the Niger River Valley, Mali, and the Bandiagara Escarpment (Cliff), Mali, describing the materials covered by these import restrictions is set forth in T.D. 97-80. The list and accompanying image database may also be found at the following internet Web site address: http://exchanges.state.gov/culprop .

The restrictions on the importation of these archaeological materials from Mali are to continue in effect for five years from September 19, 2002. Importation of these materials continues to be restricted unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.

Because the amendment to the Customs Regulations contained in this document extends import restrictions already imposed on the above-listed cultural property of Mali by the terms of a bilateral agreement entered into in furtherance of a foreign affairs function of the United States, pursuant to the Administrative Procedure Act (5 U.S.C. 553(a)(1)), no notice of proposed rulemaking or public procedure is necessary and a delayed effective date is not required.

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. Accordingly, this final rule is not subject to the regulatory analysis or other requirements of 5 U.S.C 603 and 604.

This amendment does not meet the criteria of a “significant regulatory action” as described in E.O. 12866.

The principal author of this document was Bill Conrad, Regulations.

Branch, Office of Regulations and Rulings, U.S. Customs Service.

Accordingly, part 12 of the Customs Regulations (19 CFR part 12) is amended, as set forth below:

The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which was signed into law on October 12, 1984, amended section 201 of the Controlled Substances Act (CSA)(21 U.S.C. 811) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA for one year without regard to the requirements of 21 U.S.C. 811 (b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. The Attorney General may extend the temporary scheduling up to 6 months. A substance may be temporarily scheduled under the emergency provisions of the CSA if that substance is not listed in any other schedule under section 202 of the CSA (21 U.S.C. 812) or if there is no exemption or approval in effect under 21 U.S.C. 355 for the substance. The Attorney General has delegated his authority under 21 U.S.C. 811 to the Administrator of DEA (28 CFR 0.100). The Administrator has redelgated this function to the Deputy Administrator, pursuant to 28 CFR 0.104.

A notice of intent to temporarily place BZP and TFMPP into Schedule I of the CSA was published in the Federal Register on July 18, 2002 (67 FR 47341). The Deputy Administrator transmitted notice of his intention to temporarily place BZP and TFMPP into Schedule I of the CSA to the Assistant Secretary for Health of the Department of Health and Human Services (HHS). In response to this notification, the Food and Drug Administration has advised DEA that there are no exemptions or approvals in effect under 21 U.S.C. 355 of the Food, Drug and Cosmetic Act for BZP and TFMPP and HHS has no objection to DEA's intention to temporarily place N. benzylpiperazine and 1-(3-trifluoromethylphenyl)piperazine into Schedule I of the CSA.

The Deputy Administrator has considered the available data and the following three factors required for a determination to temporarily schedule a substance under the CSA (21 U.S.C. 811 (c)):

4. Its history and current pattern of abuse;

5. Scope, duration and significance of abuse; and

6. What, if any, risk there is to the public health.

Additionally, DEA has considered the three criteria for placing a substance into Schedule I of the CSA (21 USC 812). The data available and reviewed for BZP and TFMPP indicate that they have a high potential for abuse, no currently accepted medical use in treatment in the US and are not safe for use under medical supervision.

BZP and TFMPP are piperazine derivatives, BZP was first synthesized in 1944 as a potential antiparasitic agent. There are no therapeutic applications for BZP and TFMPP, BZP and TFMPP have no accepted medical use in treatment in the United States. The safety for use of these two substances has not been determined. They are available primarily as chemical intermediates in syntheses. These two substances are similar in chemical structure and are often found to be abused together in tablets or powder form.

Abuse of BZP was first reported in late 1996 in California. BZP and TFMPP are being encountered in several regions of the United States and their abuse has spread rapidly from the states where they were initially encountered. Over the past few years, in the United States, BZP and TFMPP have increasingly been found in similar venues as the popular club drug 3,4-methylenedioxymethamphetamine (MDMA, also known as Ecstasy). BZP and TFMPP are also sold as MDMA and are targeted to the youth population. The tablet form often bears imprints commonly seen on MDMA tablets such as a fly, crown, heart, butterfly, or bull's head logos in pink, tan, white, or green. BZP and TFMPP have also been found in powder form or liquid form packaged in small convenience sizes sold on the Internet, Illicit distributions occur through smuggling of bulk powder through organizations with connections to overseas sources of supply. The bulk powder is then processed into capsule, tablet, or pill form and distributed through organized networks. These organizations also distribute other controlled substances such as MDMA, 2C-B, marijuana and anabolic steroids.

The increasing abuse of BZP and TFMPP in the United States is evidenced by increasing encounters by law enforcement agencies. DEA, State and local law enforcement agencies reported BZP and TFMPP in drug exhibits seized in the states of California, Connecticut, Florida, Illinois, Indiana, Iowa, Louisiana, Minnesota, Nevada, New York, Oregon, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin. Over fifty (50) seizures have been reported and amounted to over 39,000 tablets and 1000 pounds of powder. BZP and TFMPP are being promoted as legal alternatives to MDMA. They are often sold as “Ecstasy”, or as “BZP”, “A 2 ”, “legal E” or “legal X”. BZP and TFMPP, with their easy availability and their so-called legal status, are becoming drugs of abuse in the United States.

As with amphetamine and MDMA, the effects of BZP are stimulant-like and those of TFMPP are hallucinogen-like. The risks to the public health associated with MDMA and amphetamine, both substances with high potential for abuse, are well known and documented. BZP acts as a stimulant similar in effect to MDMA or amphetamine, producing euphoria and inducing cardiovascular effects in humans, including increased heart rate, systolic blood pressure and pulse rate. TFMPP, at approximately 100 mg, produces hallucinogenic effects similar to those produced by MDMA. TFMPP is a serotonin releasing agent and binds to serotonin receptors in the brain. In 2001, a report from University Hospital in Zurich, Switzerland details the death of a young female which was attributed to the combined use of benzylpiperazine and MDMA.

With the issuance of this final order, BZP and TFMPP become subject to regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a Schedule I controlled substance.

1. Registration. Any person who manufactures, distributes, dispenses, imports or exports BZP and TFMPP or who engages in research or conducts instructional activities with respect to BZP and TFMPP or who proposes to engage in such activities must submit an application for Schedule I registration in accordance with part 1301 of Title 21 of the Code of Federal Regulations (CFR) by October 21, 2002.

2. Security. BZP and TFMPP are subject to Schedule I security requirements and must be manufactured, distributed and stored in accordance with §§ 1301.7, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75(a) and (c) and 1301.76 of Title 21 of the Code of Federal Regulations.

3. Labeling and Packaging. All labels and labeling for commercial containers of BZP and TFMPP which are distributed on or after October 21, 2002 shall comply with requirements of §§ 1302.02-1302.07 of Title 21 of the Code of Federal Regulations.

4. Quotas. Quotas for BZP and TFMPP are established pursuant to Part 1303 of Title 21 of the Code of Federal Regulations.

5. Inventory. Every registrant required to keep records and who possesses any quantity of BZP and TFMPP is required to keep an inventory of all stocks of the substances on hand pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations. Every registrant who desires registration in Schedule I for BZP and TFMPP shall conduct an inventory of all stocks of BZP and TFMPP on or before October 21, 2002.

6. Records. All registrants are required to keep records pursuant to §§ 1304.03, 1304.04 and §§ 1304.21-1304.23 of Title 21 of the Code of Federal Regulations.

7. Reports. All registrants required to submit reports in accordance with § 1304.31 through § 1304.33 of Title 21 of the Code of Federal Regulations shall do so regarding BZP and TFMPP.

8. Order Forms. All registrants involved in the distribution of BZP and TFMPP must comply with the order form requirements of part 1305 of Title 21 of the Code of Federal Regulations.

9. Importation and Exportation. All importation and exportation of BZP and TFMPP must be in compliance with part 1312 of Title 21 of the Code of Federal Regulations.

10. Criminal Liability. Any activity with BZP and TFMPP not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act occurring on or after September 20, 2002 is unlawful.

The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. This action temporarily places BZP and TFMPP into Schedule I of the Controlled Substance Act.

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

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

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which was signed into law on October 12, 1984, amended section 201 of the CSA (21 U.S.C. 811) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA for one year without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. The Attorney General may extend the temporary scheduling up to 6 months. A substance may be temporarily7 scheduled under the emergency provisions of the CSA if that substance is not listed in any other schedule under section 202 of the CSA (21 U.S.C. 812) or if there is no exemption or approval in effect under 21 U.S.C. 355 for the substance. The Attorney General has delegated his authority under 21 U.S.C. 811 to the Administrator of DEA (28 CFR 0.100). The Administrator has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104.

A notice of intent to temporarily place 2C-T-& into Schedule I of the CSA was published in the Federal Register on July 18, 2002 (67 FR 47343). The Deputy Administrator transmitted notice of his intention to temporarily place 2C-T-7 into Schedule I of the CSA to the Assistant Secretary for Health of the Department of Health and Human Services (DHHS). In response to this notification, the Food and Drug Administration has advised DEA that there are no exemptions or approvals in effect under 21 U.S.C. 355 of the Food, Drug and Cosmetic Act for 2C-T-7 and DHHS has no objection to DEA's intention to temporarily place 2,5-dimethoxy-4-(n)-propylthiophenethylamine into Schedule I of the CSA.

As set forth under 21 U.S.C. 811(h), the Deputy Administrator has considered the available data and the following three factors under the CSA (21 U.S.C. 811(c)) that are required for a determination to temporarily schedule a substance:

4. Its history and current pattern of abuse;

5. Scope, duration and significance of abuse; and

6. What, if any, risk there is to the public health.

2,5-dimethoxy-4-(n)-propylth-phenethylamine (2C-T-7), a phenethylamine, is structurally related to the Schedule I phenethylamine 4-bromo-2,5-dimethoxyphenethylamine (2CB), and other hallucinogens ( e.g., 2,5-dimethoxy-4-methylamphetamine (DOM), and 1-(4-bromo-2,5-dimethoxyphenyl)-2-aminopropane (DOB)) in Schedule I of the CSA. 2C-T-7 has those structural features of phenethylamines which are necessary for stimulant and/or hallucinogenic activity; 2C-T-7 is a sulfur analogue of 2CB. Based on these structural features, 2C-T-7 is likely to have a pharmacological profile similar to 2CB and other Schedule I hallucinogens. The similarity in the effects of 2C-T-7 and 2CB has been supported by Shulgin and Shulgin (Pihkal: A Chemical Love Story; pp. 569-570, 1991) and by “self-reports” on the Internet. Shulgin and Shulgin (1991) reported that at an oral dose of 20 mg or 30 mg, 2C-T-7 produced visual hallucinations. They concluded that in terms of being an acceptable hallucinogen, 2C-T-7 was comparable to 2CB and mescaline. Self-reports on the Internet have described the hallucinations resulting from the self-administration of 2C-T-7 as being very 2CB-like, consisting of persistent multiple images, overlaid patterns, and trails. The subjective effects of 2C-T-7 have also been described as being similar to those of 2CB; mood lifting, sense of well being, emotionality, volatility, increased appreciation of music, and psychedelic ideation.

DEA is not aware of any approved therapeutic use of 2C-T-7 in the United States. The safety of this substance for use in humans has never been demonstrated.

The continued trafficking and abuse of 2C-T-7 poses an imminent hazard to public safety. The abuse of stimulant/hallucinogenic substances in popular all night dance parties (raves) and in other venues has been a major problem in Europe since the 1990s. In the past several years, this activity has spread to the United States. The Schedule I controlled substance MDMA and its analogues, collectively known as Ecstasy, are the most popular drugs abused at these raves. Their abuse has been associated with both acute and long-term public health and safety problems. These raves have also become venues for the trafficking and abuse of “new non-controlled” substances in place of or in addition to “Ecstasy.” 2C-T-7 is one such substance.

Illicit use of 2C-T-7 was first reported in Germany in 1997. 2C-T-7 was placed under the control of German law on January 20, 1998. In October of 1999, 2C-T-7 tablets were being sold in the Netherlands under the trade name “Blue Mystic”. Illicit use of 2C-T-7 was reported in Sweden in January of 2000. Currently 2C-T-7 is controlled under the Swedish law pertaining to goods which are dangerous to the public. French Customs authorities reported seizing tablets in 2001 that contained 10 mg of 2C-T-7.

Abuse of 2C-T-7 in the United States was first reported in 1997; an individual posted his experience associated with the oral ingestion of 20 mg of 2C-T-7 on the Lycaeum website on the Internet. In the year 2000, the abuse of 2C-T-7 by young adults began to spread in the United States as evidenced by widespread discussion on drug website forums and the sale of the substance from an Internet company. The information being discussed on these websites includes the route of administration, recommended doses, and narratives from individuals describing their experiences and effects after self-administering 2C-T-7.

Self-reported experiences and other information posted on these websites indicate that 2C-T-7 is being abused orally (10-50 mg) or intranasally; the oral route is the most common route of abuse. The powder is being mixed in liquids or placed in gelatin capsules. Information posted on these websites indicates that 2C-T-7 is being taken alone or with other drugs, such as MDMA, ketamine, cannabis, N,N-diisopropyl-5-methoxytryptamine (“Foxy Methoxy”) and N,N-dipropyltryptamine (DPT).

Information gathered by DEA indicates that 2C-T-7 has been purchased in powder form over the Internet and distributed as such. In the United States, capsules containing 2C-T-7 powder also have been encountered. In the Netherlands (“Blue Mystics”) and in Canada (“Red Raspberry”), the bulk powder is being processed into tablets.

State and local law enforcement agencies reported 2C-T-7 exhibits seized in the states of Texas and Wisconsin. In Wisconsin, two unrelated exhibits were submitted to the Wisconsin State Crime Laboratory for analysis; the first exhibit consisted of two clear capsules containing 16 to 18 milligrams of white powder and two paper packets. One packet contained 450 milligrams of tan powder and the other paper packet contained 869 milligrams. The powder in these exhibits was identified as 2C-T-7. These two capsules were sold to an informant as “Twenty-Bird Mescaline.” The second exhibit analyzed by the Wisconsin State Crime Laboratory was shown to be a mixture of 2C-T-7 and N,N-dipropyltryptamine (DPT). 2C-T-7 has also appeared in illicit traffic in Tennessee, Washington, and Oklahoma, as evidenced by the 2C-T-7 related deaths in these states. To date, DEA has not identified a clandestine laboratory synthesizing 2C-T-7.

2C-T-7 shares those structural similarities with 2CB and other phenethylamines (i.e., DOB, and DOM) which makes it likely to produce similar public health risks. Sensory distortion and impaired judgment can lead to serious consequences for both the user and the general public. 2C-T-7 can have lethal effects when abused alone or in combination with other illicit drugs. To date, three deaths have been associated with the abuse of 2C-T-7. The first death occurred in Oklahoma during April of 2000; a young healthy male overdosed on 2C-T-7 following intranasal administration. The co-abuse of 2C-T-7 with MDMA will pose a significant health risk if 2C-T-7 popularity increases in the same venues as with MDMA. The co-abuse of 2C-T-7 with MDMA has resulted in lethal effects. The other two 2C-T-7 related deaths resulted from the co-abuse of 2C-T-7 with MDMA. They both occurred in April of 2001. One young man died in Tennessee while another man died in the state of Washington.

While the issuance of this final order, 2C-T-7 becomes subject to regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a Schedule I controlled substance.

1. Registration. Any person who manufactures, distributes, dispenses, imports or exports 2C-T-7 or who engages in research or conducts instructional activities with respect to 2C-T-7 or who proposes to engage in such activities must submit an application for Schedule I registration in accordance with part 1301 of Title 21 of the Code of Federal Regulations (CFR) by October 21, 2002.

2. Security. 2C-T-7 is subject to Schedule I security requirements and must be manufactured, distributed and stored in accordance with §§ 1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75(a) and ( c ) and 1301.76 of the Title 21 of the Code of Federal Regulations.

3. Labeling and Packaging. All labels and labeling for commercial containers of 2C-T-7 which are distributed on or after October 21, 2002. Shall comply with requirements of §§ 1302.03-1302.07 of Title 21 of the Code of Federal Regulations.

4. Quotas. Quotas for 2C-T-7 are established pursuant to part 1303 of Title 21 of the Code of Federal Regulations.

5. Inventory. Every registrant required to keep records and who possesses any quantity of 2C-T-7 is required to keep inventory of all stocks of this substance on hand pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations. Every registrant who desires registration in Schedule I for 2C-T-7 shall conduct an inventory of all stocks of 2C-T-7 on or before October 21, 2002.

6. Records. All registrants are required to keep records pursuant to §§ 1304.03, 1304.4 and §§ 1304.21-1304.23 of Title 21 of the Code of Federal Regulations.

7. Reports. All registrants required to submit reports in accordance with § 1304.31 through § 1304.33 of Title 21 of the Code of Regulations shall do so regarding 2C-T-7.

8. Order Forms. All registrants involved in the distribution of 2C-T-7 must comply with the order form requirements of part 1305 of Title 21 of the Code of Federal Regulations.

9. Importation and Exportation. All importation and exportation of 2C-T-7 shall be in compliance with part 1312 of Title 21 of the Code of Federal Regulations.

10. Criminal Liability. Any activity with 2C-T-7 not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act occurring on or after September 20, 2002 is unlawful.

The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. This action temporarily places 2C-T-7 into Schedule I of the CSA.

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

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

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Throughout this document wherever “we”, “us”, or “our” are used we mean the Environmental Protection Agency.

In this action, we are determining that the metropolitan Provo CO nonattainment area, as described in 40 CFR 81.345, attained the 8-hour CO NAAQS by December 31, 1995, based on quality assured ambient air monitoring data for the years 1994 and 1995. In addition, ambient air quality data show that the area continued to attain the CO NAAQS from 1995 through 2001 (the most recent year for which complete data are available.) This action is being taken pursuant to sections 179 (c)(1) and 186(b)(2) of the Clean Air Act (CAA). This determination of attainment does not redesignate the Provo area to attainment for the CO NAAQS. The CAA requires that for an area to be redesignated to attainment the five criteria in section 107(d)(3)(E) must first be satisfied and EPA must fully approve a maintenance plan for the area.

On November 15, 1990, the Clean Air Act Amendments of 1990 were enacted (Pub. L. 101-549, 104 Stat. 2399, codified at 42 U.S.C. 7401-7671q). Under section 107(d)(1)(C) of the CAA, we designated the Provo area as nonattainment for CO because the area had been designated as nonattainment before November 15, 1990. We originally designated the Provo area as nonattainment for CO under the provisions of the 1977 CAA Amendments (see 43 FR 8962, March 3, 1978). This designation was reaffirmed by the 1990 CAA Amendments and the Provo area was classified as “moderate” CO nonattainment area with a design value greater than or equal to 12.7 parts per million (ppm). See 56 FR 56694, November 6, 1991. CO nonattainment areas classified as “moderate” were expected to attain the CO NAAQS as expeditiously as practical, but no later than December 31, 1995. Further information regarding this CO classification and the accompanying requirements are described in section 187 of the CAA and in the “General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990.” (See 57 FR 13498, April 16, 1992.)

As described in 40 CFR 50.8, the national primary ambient air quality standard for carbon monoxide is 9 parts per million (10 milligrams per cubic meter) for an 8-hour average concentration not to be exceeded more than once per year. 40 CFR 50.8 continues by stating that the levels of CO in the ambient air shall be measured by a reference method based on 40 CFR part 50, appendix C and designated in accordance with 40 CFR part 53 or an equivalent method designated in accordance with 40 CFR part 53. Attainment of the CO standard is not a momentary phenomenon based on short-term data. Instead, we consider an area to be in attainment if each of the CO ambient air quality monitors in the area doesn't have more than one exceedance of the CO standard over a one-year period. 40 CFR 50.8 and 40 CFR part 50, appendix C. If any monitor in the area's CO monitoring network records more than one exceedance of the CO standard during a one-year calendar period, then the area is in violation of the CO NAAQS. In addition, our interpretation of the CAA has been that to be considered in attainment for the CO NAAQS, an area must attain the CO NAAQS for at least a continuous two-year calendar period. 1

Our determination that the Provo area attained the CO NAAQS by December 31, 1995, is based on an analysis of quality assured ambient air quality monitoring data that have been entered into EPA's Aerometric Information and Retrieval System (AIRS) and are relevant to this action. State annual-certified ambient air quality monitoring data for calendar years 1994 and 1995 show a measured design value of 8.2 ppm with an exceedance rate of the CO NAAQS of 1.0 or less per year, per monitor, in the Provo nonattainment area. In addition, we note that ambient data in AIRS show continuous attainment of the CO NAAQS in the Provo area from 1995 through the latest complete data year of record which is 2001. Further, preliminary data for 2002 also show attainment.

All of the data discussed above were collected and analyzed as required by EPA (see 40 CFR 50.8 and 40 CFR part 50, appendix C) and in accordance with EPA policy and guidance. The data have been archived by the State in our AIRS national database. We have evaluated the ambient air quality data and have determined that the Provo area has not violated the CO standard. Therefore, the Provo area has met its CAA requirement and attained the CO NAAQS by December 31, 1995.

Section 211(m) of the 1990 CAA Amendments required the implementation of an oxygenated gasoline program in CO nonattainment areas with a CO design value greater than 9.5 ppm. As both the Provo area (Utah County) and Ogden City (Weber County) were nonattainment for CO and had design values greater than 9.5 ppm, this provision of the CAA applied to both Weber and Utah Counties. CAA section 211(m)(2)(B) set the Federally required oxygenate level at 2.7% oxygen by weight. In response to this CAA requirement, the Governor submitted final revisions to the State's rule R307-8 2 “Oxygenated Gasoline Program” on May 14, 1994, for the implementation of a 2.7% program. We approved the revisions to R307-8 on November 8, 1994 (see 59 FR 55585).

On July 11, 1994, the Governor submitted a revision to the Utah SIP that included a CO attainment demonstration for the Provo area. Two components of this attainment demonstration were the implementation of an enhanced motor vehicle inspection and maintenance (I/M) program, to be implemented by January 1, 1996, and the 2.7% oxygenated gasoline program. (We note that the State had actually implemented the 2.7% oxygenated gasoline program in the Provo area even prior to our November 8, 1994, approval of R307-8 and has continued the implementation of this 2.7% program to date.) However, the commitment to implement an enhanced I/M program was not definite. Thus, as part of the July 11, 1994, submittal the State revised R307-8-3.1.B “Average Oxygen Content Standard” to require an increase in the oxygen content of gasoline fuels in the Provo-Orem Metropolitan Statistical Area (MSA) from 2.7% to 3.1% oxygen by weight in the event the enhanced I/M program (or a substitute I/M program) was not implemented by January 1, 1996.

The State did not implement the enhanced I/M program in Utah County. Instead, on March 15, 1996, the Governor submitted a revision to the SIP that involved an improved basic I/M program for Utah County. This revision was submitted to satisfy the applicable requirements of both the CAA and section 348 of the National Highway Safety Designation Act (NHSDA) of 1995. We granted interim final approval of this SIP revision on June 9, 1997 (see 62 FR 31349) and we anticipate publishing a final rule fully approving this improved basic I/M program in the near future.

After our November 8, 1994, initial approval of the State's oxygenated gasoline program, the State submitted several revisions to R307-8 which culminated in a submittal by the Governor on July 8, 1998, that superceded and replaced all prior versions. This July 8, 1998, version of R307-8 still retained the language in R307-8-3.1.B requiring the implementation of a 3.1% oxygen content by weight program in Utah County if the enhanced I/M program was not implemented in Utah County by January 1, 1996. We approved the July 8, 1998, revision of R307-8 in conjunction with our March 9, 2001, approval of the Ogden City carbon monoxide redesignation to attainment (see 66 FR 14078), thus making the 3.1% program both State and Federally enforceable for Utah County and the Provo area. (We note that R307-8 never applied the 3.1% program in Ogden City.)

Utah's rule R307-301 is entitled “Utah and Weber Counties: Oxygenated Gasoline Program.” It is intended to replace R307-8. The Governor's September 27, 2001, SIP submittal made specific changes to R307-301-3 which is entitled “Average Oxygen Content Standard.”

Section 110(k) of the CAA addresses our actions on submissions of revisions to a SIP. The CAA requires States to observe certain procedural requirements in developing SIP revisions for submittal to us. Section 110(a)(2) of the CAA requires that each SIP revision be adopted after reasonable notice and public hearing. This public process must occur prior to the State submitting its final revisions to us.

At the July 11, 2001, Utah Air Quality Board (UAQB) meeting, the UAQB proposed for public comment revisions to rule R307-301-3. The SIP revisions were subject to a 30-day State public comment period that began on August 1, 2001, and ended on August 31, 2001. The State conducted a public hearing on August 22, 2001. The UAQB approved the SIP revisions on September 5, 2001. Rule R307-301-3 became State-effective on September 10, 2001. The Governor submitted these SIP revisions to EPA on September 27, 2001. In a letter dated October 18, 2001, from Pat D. Hull, Acting Regional Administrator, to Governor Leavitt, we determined the submittal was administratively and technically complete pursuant to 40 CFR part 51, appendix V.

The revisions to R307-301-3 that the Governor submitted on September 27, 2001, remove the requirement for a 3.1% oxygen content by weight program and require only a 2.7% oxygen by weight program. We find the revisions acceptable for the following reasons:

The revisions will not interfere with the attainment of the CO NAAQS or any other requirement of the CAA. As noted above, the Provo area has been continuously attaining the CO NAAQS since 1994. During this period, the Provo area has never implemented a 3.1% oxygenated gasoline program and has only implemented a 2.7% oxygenated gasoline program. Only three exceedances of the CO NAAQS have been recorded in the Provo area since 1994 and none have been recorded since 1996. Also, the CO values since 1996 have generally been considerably below the CO NAAQS and trending downward. Thus, we believe a 2.7% oxygenated gasoline program will continue to be adequate for the Provo area to attain the 8-hour CO NAAQS. Any additional CO emission reductions that a 3.1% oxygenated gasoline program would achieve appear to be unnecessary.

Based on the above analysis and the ambient air quality data that is archived in our AIRS national database for the Provo area, we have concluded that a 2.7% oxygenated gasoline program is sufficient for the Provo area to attain and maintain the CO NAAQS. Therefore, the Governor's September 27, 2001, revisions to R307-301-3 are acceptable.

In this action, EPA is determining that the Provo carbon monoxide “moderate” nonattainment area attained the CO NAAQS by December 31, 1995. We are also approving the Governor's September 27, 2001, revisions to Utah's rule R307-301-3 “Average Oxygen Content Standard.”

EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial action and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal should adverse comments be filed. This rule will be effective November 19, 2002, without further notice unless the Agency receives adverse comments by October 21, 2002.

If EPA receives such comments, then we will publish a timely withdrawal of the direct final rule informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this rule. Any parties interested in commenting on this rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on November 19, 2002, and no further action will be taken on the proposed rule.

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

Protection of Children from Environmental Health Risks and Safety Risks (62 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 economically significant and EPA does not have the discretion to engage in a risk assessment or alternatives analysis in acting on SIP revisions.

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

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

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.”

This final rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

This rule is not subject to Executive Order 13211 “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

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 approval will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements, but simply approve requirements that the State is already imposing. Therefore, because the SIP final approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. , v. U.S. EPA , 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2). Therefore, because the final rule does not create any new requirements, I certify that the final rule 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 this final approval action does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective November 19, 2002.

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

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

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 November 19, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket ID number OPP-2002-0238. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of May 1, 2002 (67 FR 21676) (FRL-6834-7) and August 22, 2001 (66 FR 44136) (FRL- 6794-6) , EPA issued notices pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP 2E6356, 2E6372, 2E6375, and 2E6376) by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390 and 0F6218 by Syngenta Crop Protection, Inc., 410 Swing Road, P.O. Box 18300, Greensboro, NC 27409-8300. These notices included summaries of the petitions prepared by Syngenta Crop Protection, the registrant. There were no comments received in response to the notices of filing.

The petitions requested that 40 CFR 180.507 be amended by establishing tolerances for combined residues of the fungicide azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate and the Z-isomer of azoxystrobin, methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxyphenyl)-3- methoxyacrylate, in or on food commodities as follows:

1. PP 2E6356 proposed a tolerance for the caneberry subgroup at 5.0 ppm.

2. PP 2E6372 proposed to increase the established tolerance for pistachio from 0.02 ppm to 1.0 ppm. The petition was subsequently revised to propose a tolerance for pistachio at 0.50 ppm.

3. PP 2E6376 proposed a tolerance for cranberry at 0.50 ppm.

4. PP 0F6218 proposed tolerances for the vegetable, legume, group at 3.0 ppm; hop, dried cones at 50 ppm. The petition was subsequently revised to propose tolerances for the vegetable, legume, edible podded subgroup, except soybean at 3.0 ppm; pea and bean, succulent shelled, subgroup, except cowpea at 0.50 ppm; pea and bean, dried shelled, except soybean subgroup, except cowpea and field pea at 0.50; and hop, dried cones at 20.0 ppm.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of azoxystrobin and its Zisomer on caneberry subgroup at 5.0 ppm; cranberry at 0.50 ppm; hop, dried cones, at 20.0 ppm; pistachio at 0.50 ppm; vegetable, legume, edible podded, subgroup, except soybean at 3.0 ppm; pea and bean, succulent shelled, subgroup, except cowpea at 0.50 ppm; pea and bean, dried shelled, except soybean subgroup, except cowpea and field pea at 0.50. EPA's assessment of exposures and risks associated with establishing the tolerances follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by azoxystrobin is discussed in Unit III.A. of the Federal Register of September 29, 2000 (65 FR 58404) (FRL-6749-1).

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

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

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

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

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.507) for the combined residues of azoxystrobin and its Zisomer, in or on a variety of raw agricultural commodities at levels ranging from 0.01 ppm (pecans) to 55 ppm (soybean hay), and on meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep at levels ranging from 0.01 to 0.07 ppm, and on milk at 0.006 ppm. Time-limited tolerances (set to expire on December 31, 2003) are established at 30 ppm for the Brassica, head and stem subgroup; at 0.5 ppm for chick pea, seed; at 3.0 ppm for lychee; and at 2.0 ppm for pepper. Risk assessments were conducted by EPA to assess dietary exposures from azoxystrobin in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: 100% of the crops with azoxystrobin tolerances (established and recommended) are treated and that all commodities contain tolerance level residues when consumed (with the exception of those with processing factors). DEEM TM default processing/concentration factors were used for all processed commodities.

ii. Chronic exposure . In conducting this chronic dietary risk assessment, the Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: 100% of the crops with azoxystrobin tolerances (established and recommended) are treated and that all commodities contain tolerance level residues when consumed (with the exception of those with processing factors). DEEM TM default processing/concentration factors were used for all processed commodities.

iii. Cancer . Azoxystrobin was classified by the Agency as not likely to be a human carcinogen. Therefore, a cancer dietary exposure analysis was not performed.

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water, EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, 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 screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would 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 azoxystrobin, they are further discussed in the aggregate risk sections.

Although moderately persistent in soils and stable to hydrolysis, the likelihood of azoxystrobin moving into ground water and surface water is low due to high soil/water partitioning coefficients and low single application rates. Three major degradates were detected and found to have greater potential to move through soil than the parent compound.

Based on the FIRST model, the estimated environmental concentrations (EECs) of azoxystrobin for acute and chronic exposures are estimated to be 170 parts per billion (ppb), and 33 ppb for surface water, respectively. Based on the SCI-GROW model the EECs of azoxystrobin for both acute and chronic exposures are estimated to be 3.1 ppb for ground water. These values were based on the highest use rate (turf use). These values represent upper-bound estimates of the concentrations that might be found in surface water and ground water which result from the use of azoxystrobin on turf.

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).

Azoxystrobin is currently registered for use on the following residential non-dietary sites: turf and ornamentals. The risk assessment was conducted using the following residential exposure assumptions: Products containing azoxystrobin are registered for application to turf and ornamentals. They may be applied to turf at rates up to 0.95 lb active ingredient (ai) per acre (not to exceed 5 lb ai/acre/yr) and to ornamentals at rates up to 0.75 lb/ai/per acre every 7 to 14 days, but not to exceed 5 lb ai/acre/yr. The currently registered labels do not prohibit homeowners from mixing/loading/applying either the flowable concentrate or the water-dispersible granule formulations. This residential exposure and risk assessment was conducted using the application rate for turf because it is the highest single use rate.

Residential handlers may receive short-term dermal and inhalation exposure to azoxystrobin when mixing, loading, and applying the formulations. Adults and children may be exposed to azoxystrobin residues from dermal contact with foliage during post-application activities. Toddlers may receive short- and intermediate-term oral exposure from incidental ingestion during post-application activities.

As no dermal endpoint was selected by the Agency, a dermal exposure and risk assessment was not conducted for residential handlers or post-application activities.

Therefore, only the following exposure scenarios resulting from lawn treatment were assessed: (1) Toddlers' incidental ingestion of pesticide residues on lawns from hand-to-mouth transfer, (2) object-to-mouth transfer from mouthing of pesticide-treated turfgrass, and (3) incidental ingestion of soil from pesticide-treated residential areas, (4) short-term inhalation for residential handlers. Post-application exposures from various activities following lawn treatment are considered to be the most common and significant in residential settings. The exposure via incidental ingestion of other plant material may occur but is considered negligible.

The exposure and risk estimates for the post-application residential exposure scenarios are assessed for the day of application (day 0) because it is assumed that toddlers could contact the lawn immediately after application. Both short-term and intermediate-term exposure are expected. Risk from short-term and intermediate-term incidental ingestion by toddlers is assessed by comparing these exposures to the NOAELs of 25 milligrams/kilogram/day (mg/kg/day) and 21 mg/kg/day, respectively. Short-term adult handler risk is assessed by comparing exposure to the short-term inhalation NOAEL of 25 mg/kg/day.

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

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

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

2. Prenatal and postnatal sensitivity . The developmental and reproductive toxicity data, from a prenatal development study in rats, a prenatal development study in rabbits, and a two-generation reproductive toxicity study in rats, did not indicate increased susceptibility of young rats or rabbits to in utero and/or postnatal exposure.

3. Conclusion . There is a complete toxicity data base for azoxystrobin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because: (1) The toxicology data base is complete; (2) the developmental and reproductive toxicity data did not indicate increased susceptibility of rats or rabbits to in utero and/or postnatal exposure; (3) unrefined chronic dietary exposure estimates (assuming all commodities contain tolerance level residues) will overestimate dietary exposure; (4) modeling data are used for ground and surface source drinking water exposure assessments resulting in estimates considered to be upper-bound concentrations.

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

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to azoxystrobin will occupy 12% of the aPAD for the U.S. population, 12% of the aPAD for females (13-50 years old), 21% of the aPAD for children (1-6 years old), and 12% of the aPAD for seniors (55+ years). In addition, there is potential for acute dietary exposure to azoxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to azoxystrobin from food will utilize 13% of the cPAD for the U.S. population, 21% of the cPAD for children (1-6 years old), 12% of the cPAD for females (13-50 years old), and 14% of the cPAD for seniors (55+ years old). Based on the use pattern, chronic residential exposure to residues of azoxystrobin is not expected. In addition, there is potential for chronic dietary exposure to azoxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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). The short-term aggregate risk assessment estimates risks likely to result from 1- to 30-day exposure to azoxystrobin residues from food, drinking water, and residential pesticide uses. High-end estimates of residential exposure are used in the short-term assessment, while average values are used for food and drinking water exposure.

A short-term risk assessment is required for adults because there is a residential handler inhalation exposure scenario. In addition, a short-term risk assessment is required for infants and children because there is a residential post-application oral exposure scenario. As no short-term dermal endpoint was established, there is no dermal component to this aggregate risk assessment.

Azoxystrobin is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for azoxystrobin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,100 for adults and 450 for children (1-6 years old). These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of azoxystrobin in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 4:

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The intermediate-term aggregate risk assessment estimates risks likely to result from 1-6 months of exposure to azoxystrobin residues from food, drinking water, and residential pesticide uses. High-end estimates of residential exposure are used in the intermediate-term assessment, while average values are used for food and drinking water exposure.

An intermediate-term risk assessment is not required for adults because residential handler scenarios are not expected to occur for longer than a short-term timeframe. However, an intermediate-term risk assessment is required for infants and children because there is a residential post-application oral exposure scenario. As no dermal endpoint was established, there is no dermal component to this aggregate risk assessment.

Azoxystrobin is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for azoxystrobin.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 440 for children 1-6 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of azoxystrobin in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5:

5. Aggregate cancer risk for U.S. population . Azoxystrobin was classified by EPA as not likely to be a human carcinogen. The Agency concludes that pesticides uses of azoxystrobin are not likely to pose a carcinogenic hazard to 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 azoxystrobin residues.

Adequate methodology is available for enforcement of the proposed tolerances for azoxystrobin and its z-isomer on plants. An enforcement method for azoxystrobin in livestock commodities has been validated by the EPA analytical laboratory for the analysis of milk and livestock tissues.

The method may be requested from: Paul Golden, US EPA/OPP/BEAD/ACB, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone number: (410) 305-2960; Fax: (410) 305-3091; e-mail address: RAM Mailbox.

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been established for residues of azoxystrobin on caneberries, cranberries, pistachios, hops, or legumes.

Therefore, the tolerances are established for combined residues of azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate and the z-isomer of azoxystrobin, methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxyphenyl)-3- methoxyacrylate, in or on caneberry subgroup at 5.0 ppm; cranberry at 0.50 ppm; hop, dried cones at 20.0 ppm; pistachio at 0.5 ppm; vegetable, legume, edible podded, subgroup, except soybean at 3.0 ppm; pea and bean, succulent shelled, subgroup, except cowpea at 0.50 ppm; and pea and bean, dried shelled, except soybean subgroup, except cowpea and field pea at 0.50.

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 ID number OPP-2002-0238 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 November 19, 2002.

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 VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0238, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

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

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

1. Electronically .You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/ . To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

2. In person . The Agency has established an official record for this action under docket control number OPP-2002-0253. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305--5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for residues of the insecticide diflubenzuron, [N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide], in or on alfalfa, forage and alfalfa, hay at 6.0 parts per million (ppm). These tolerances will expire and are revoked on June 30, 2004. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

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

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

Recently, EPA has received objections to a tolerance it established for diflubenzuron on a different food commodity. The objections were filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. Although these objections concern separate rulemaking proceedings under the FFDCA, EPA has considered whether it is appropriate to establish the emergency exemption tolerances for diflubenzuron while the objections are still pending.

Factors taken into account by EPA included how close the Agency is to concluding the proceedings on the objections, the nature of the current action, whether NRDC's objections raised frivolous issues, and extent to which the issues raised by NRDC had already been considered by EPA. Although NRDC's objections are not frivolous, the other factors all support establishing these tolerances at this time. First, the objections proceeding is not near to conclusion. NRDC's objections raise complex legal, scientific, policy, and factual matters and on August 16, 2002, EPA extended (for an additional 30 days) the public comment period on these objections, first initiated for 60 days in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-7) and on August 16, 2002 (67 FR 53505) (FRL-7193-6). Second, the nature of the current action is extremely time sensitive as it addresses an emergency situation. Third, the issues raised by NRDC are not new matters but questions that have been the subject of considerable study by EPA and comment by stakeholders. Accordingly, EPA is proceeding with establishing these tolerances for diflubenzuron.

The Applicant (Utah Department of Agriculture and Food) states that outbreaks of the Mormon cricket and various grasshopper species have increased in Utah's alfalfa fields this season, due in large part to the drought being experienced. Because of the drought conditions, there is no feed on public lands for the insects, and the insects are moving faster to the private farmland in Utah. Historically, grasshoppers and crickets have posed a threat to all crops, even plaguing pioneers 150 years ago. The Mormon cricket can be economically devastating, and destroys sagebrush, alfalfa, small grains, seed, grasses, and vegetable crops. Grasshoppers have also been increasing in localized areas during the past four years, and in 2001, the Applicant states that crop production was hit hard from the heavily infested spots from both the grasshoppers and the Mormon cricket. Many fields left untreated in 2001 experienced a 100% reduction in yield, and the Applicant states that the infestation levels for 2002 are even greater than estimated. While there are several chemical controls registered for use in Utah for crickets and grasshoppers, regulations prohibiting more than one application combined with prohibitive costs make multiple applications an ineffective solution. The Applicant states that diflubenzuron is the only pesticide that has been proven effective for full-season control of grasshopper and cricket outbreaks. Diflubenzuron has a longer period of residual activity than the registered alternatives, which allows for control of delayed hatching nymphs, later hatching grasshopper species, and secondary infestations, which precludes the need for additional applications. The Applicant asserts that the registered alternative have very short residual activity and/or are prohibitively expensive for use in this situation. Significant economic losses were expected to occur this year for alfalfa producers, without the use of diflubenzuron to control these pests. EPA has authorized under section 18 of FIFRA the use of diflubenzuron on alfalfa for control of the Mormon cricket and various grasshopper species in Utah. 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 diflubenzuron in or on alfalfa forage and hay. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with section 18 of FIFRA. 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 establishing 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 June 30, 2004, under section 408(l)(5)of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on alfalfa forage and hay 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 the level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether diflubenzuron meets EPA's registration requirements for use on alfalfa 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 diflubenzuron by a State for special local needs under section 24(c) of FIFRA. Nor do these tolerances serve as the basis for any State other than Utah 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 diflubenzuron, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of diflubenzuron and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for residues of diflubenzuron in or on alfalfa hay and forage at 6.0 ppm.

No alfalfa residue data were submitted for this request. The proposed use rate of diflubenzuron for alfalfa is the same as that registered for use on grass. Therefore, the data from grass was translated to alfalfa for this section 18 use. The established tolerances for meat and milk commodities are adequate to cover any residues which may result from this section 18 use. Based upon previous feeding studies, the secondary residues in meat and milk will not exceed the established tolerances as a result of this section 18 use.

Residues of diflubenzuron in/on alfalfa are not expected to increase dietary exposure. Since alfalfa is not consumed by humans, any exposure to residues of diflubenzuron from this emergency exemption use will result from the consumption of meat or milk. The use of diflubenzuron in alfalfa is not expected to result in exceedances of the tolerances that already exist for meat and milk. Therefore, establishing the alfalfa tolerances will not increase the most recent estimated aggregate risks resulting from the use of diflubenzuron, as discussed in the Federal Register for February 15, 2002 (67 FR 7085) (FRL-6821-7) final rule establishing a tolerance for residues of diflubenzuron in/on pears, because in that prior action, risk was estimated assuming all meat and milk commodities contained tolerance level residues. Refer to the February 15, 2002 Federal Register document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon that risk assessment and the findings made in the Federal Register document in support of this action. Below is a brief summary of the aggregate risk assessment.

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. A summary of the toxicological dose and endpoints for diflubenzuron for use in human risk assessment is discussed in final rule mentioned above, published in the Federal Register of February 15, 2002.

EPA assessed risk scenarios for diflubenzuron under chronic exposures only. Acute toxicological endpoints have not been identified for diflubenzuron, and there are no registered or proposed uses which would result in short- and intermediate-term exposure; thus these exposure analyses were not necessary. Although diflubenzuron itself is not classified as a carcinogen, two of its metabolites, PCA (p-chloroaniline) and CPU (p-chlorophenylurea) are probable human carcinogens and have been assigned Q1*s. Since these degradates are found in mushrooms, milk, and liver, as a result of diflubenzuron use, EPA has concluded that the residues of concern are diflubenzuron and its metabolites PCA and CPU.

The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity.

The following assumptions were made for the chronic exposure assessments: Anticipated residue information based on field trial data, and percent of crop treated (%CT) information for some commodities were used (Tier 3). A value of 1% was used for %CT values < 1%.

Using these exposure assessments, the EPA concluded that exposure to diflubenzuron from food will utilize < 1% of the chronic population adjusted dose (cPAD) for the US Population, 5% for Infants ( < 1 yr old), and < 1% for Children (1 to 6 years old). In addition, despite the potential for dietary exposure to diflubenzuron in drinking water, after calculating drinking water levels of concern (DWLOCs) and comparing them to conservative model estimated environmental concentrations (EECs) of diflubenzuron in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 1.

Cancer aggregate risk assessments were not performed for diflubenzuron and PCA, since diflubenzuron is not a carcinogen and PCA is not a significant degradate in drinking water. The potential cancer risk from dietary (food only), exposure to residues of PCA is 4.7 x 10 - 7 , which is negligible. The results of the cancer analysis for CPU indicate that the estimated cancer dietary (food only) risk from CPU 3.8 x 10 - 8 associated with the proposed use of diflubenzuron is below the Agency's level of concern. In addition, there is potential for chronic dietary exposure to CPU in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate cancer risk to exceed EPA's level of concern, as shown in the following Table 2:

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 diflubenzuron residues.

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

There are no Codex maximum residue limits (MRLs) established for diflubenzuron on alfalfa forage and hay. Therefore, no compatibility problems exist for the proposed tolerances.

One application may be made using ground or aerial equipment, at a rate of 2 fl. oz. of product (0.0325 lb. active ingredient) per acre. A 14-day pre-harvest interval and a 12-hour re-entry interval must be observed.

Therefore, the tolerances are established for residues of diflubenzuron, [N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide], in or on alfalfa forage, and alfalfa hay at 6.0 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA 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 sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-2002-0253 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 November 19, 2002.

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

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

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

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

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-2002-0253, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes time limited tolerances under section 408 of the FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a section 18 FIFRA exemption under section 408 of the FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet home page at http://www.epa.gov/ . To access this document, on the home page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket ID number OPP-2002-0243. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of June 3, 2002 (67 FR 38276) (FRL-7179-2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of a pesticide petition (PP 1E6322) by Interregional Research Project Number 4(IR-4), 681 U.S. Highway 1 South, North Brunswick, New Jersey 08902-3390. In addition to the Federal Register of August 31, 2001 (66 FR 45993) (FRL-6796-1), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a, as amended by the FQPA announcing the filing of pesticide petitions 0F6169 and 1F6229) by Gowan Company, P.O. Box 5569; Yuma, AZ 85366. These notices included a summary of the petitions prepared by Gowan Company, the registrant. There were no comments received in response to these notices of filing.

The petitions requested that 40 CFR 180.479(a) be amended by establishing tolerances for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyaminosulfonyl-3-chloro-1-methyl-1 H -pyrazole-4-carboxylate, in or on vegetables, fruiting (except cucurbits), group at 0.05 part per million (ppm) (PP 0F6169), asparagus at 0.8 ppm (1F6229); and dry bean and succulent snap bean at 0.05 ppm (1E6322). The tolerance in or on asparagus at 0.8 ppm established by the current action will replace the time limited tolerance for asparagus established under § 180.479(b) in the Federal Register of December 27, 2001 (66 FR 66778) (FRL-6816-1).

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of halosulfuron-methyl on asparagus at 0.8 ppm; bean, dry, seed at 0.05 ppm; bean, snap, succulent at 0.05 ppm and vegetables, fruiting (except cucurbits), group at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by halosulfuron-methyl are discussed in Unit II.A. of the final rule on halosulfuron-methyl pesticide tolerances in the Federal Register of September 29, 2000 (65 FR 58424) (FRL-6746-2).

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

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

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

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

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet home page at http://www.epa.gov/. To access this document, on the home page select “Laws and Regulations”, “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00 .html , a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket ID number OPP-2002-0219. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Registers of January 10, 2000, 65 FR 1370-1381; FRL-6394-6; March 19, 2001, 66 FR 15432-15459; FRL-6766-7; May 23, 2001, 66 FR 28482-28487; FRL-6782-5 and August 24, 2001, 66 FR 44629-44634; FRL-6796-2; and August 14, 2002, 67 FR 52996-53001; FRL-7191-9. EPA issued notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of a pesticide petitions (PP 9F6033; 9F6062; 0F6201; 0F6213; 1F 6259; 1F6287; 2E6382 and 2E6408) by Rohm and Haas Company,100 Independence Mall West, Philadelphia, PA 19106-2399 and the Interregional Research Project Number 4 (IR-4), Technology Centre of New Jersey, the State University of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. These notices included a summary of the petitions prepared by Rohm and Haas Company, the registrant or the Interregional Research Project Number 4 (IR-4). There were no comments received in response to these notices of filing.

The petitions requested that 40 CFR 180.544 be amended by establishing tolerances for residues of the insecticide methoxyfenozide in or on almond, hulls; artichoke, globe; field corn grain; field corn forage; field corn stover (fodder); corn, oil; aspirated grain fractions; sweet corn (K + CWHR); sweet corn forage; sweet corn stover (fodder); corn silage; stone fruits crop group; prunes; grapes; Spanish lime; longan; lychee; tree nut crop group; pulasan; raisins; rambutan; fruiting vegetables (except cucurbits); crop subgroup 4A leafy green vegetables; 4B leaf petioles; head and stem Brassica; crop subgroup 5B leafy Brassica greens; at 45.0, 3.0, 0.05, 15.0, 105, 0.2, 1.0, 0.05, 30, 60, 5.0, 5.0, 7.0, 1.0, 2.0, 2.0, 2.0, 0.1, 2.0, 1.5, 2.0, 2.0, 25.0, 10.0, 6.5, 20 parts per million (ppm) respectively and an increase in the established tolerance for residues of methoxyfenozide to 0.1 ppm in milk and an increase in the established tolerances for residues of methoxyfenozide and its glucuronide metabolite in the fat of cattle, goats, horses, hogs and sheep; liver of cattle, goats, horses, hogs and sheep; and meat byproducts (except liver) of cattle, goats, horses hogs and sheep to 0.5, 0.4 and 0.1 ppm respectively. These petitions also requested that 40 CFR 180.544 be amended by establishing time limited tolerances for the indirect or inadvertent residues of methoxyfenozide and its metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-dimethylbenzoic acid N -tert-butyl- N '-(3-hydroxy-2-methylbenzoyl) hydrazide, RH-151,055 glucose conjugateof RH-117,236; 3,5-dimethylbenzoicacid N -tert-butyl- N -[3( β -D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate of RH 117,236 in or on root and tuber vegetables; leaves of root and tuber vegetables; bulb vegetables; leafy vegetables (except Brassica); Brassica vegetables; legume vegetables; foliage of legume vegetables; forage, fodder, hay, and straw of cereal grains; grass forage, fodder and hay; forage, fodder, straw and hay of non-grass animal feeds; and herbs and spices when present therein as a result of application of methoxyfenozide to growing crops at 0.05, 0.1, 0.1, 0.2, 0.2, 0.05, 8.0, 7.0, 7.0, 8.0 and 8.0 ppm respectively.

Based on the residue data submitted, EPA has determined that the following changes to the requested tolerances listed above are necessary. A higher tolerance of 125 ppm is required for field corn stover. A higher tolerance of 30.0 ppm is required for vegetable, leafy (except Brassica), leafy greens subgroup. A higher tolerance of 25 ppm is required for vegetable, leafy (except Brassica), leaf petioles subgroup. A higher tolerance of 7.0 ppm is required for vegetables, leafy, Brassica (cole), head and stem subgroup. A higher tolerance of 30.0 ppm is required for vegetables, leafy, Brassica (cole), greens subgroup. A separate tolerance of 0.30 is needed for plums (fresh prune). A lower tolerance of 25.0 ppm is required for almond hulls. A higher tolerance of 2.0 ppm is required for aspirated grain fractions. No tolerance is required for corn silage since residues in silage are covered by the proposed tolerance for field corn forage. A tolerance for processed prunes is not needed. A lower tolerance of 3.0 ppm is required for stone fruit (except plum, fresh prune). The proposed higher tolerances for hog commodities are not needed. A tolerance of 0.02 ppm is required for poultry, fat and 0.02 for poultry, meat. A tolerance of 0.02 ppm is required for eggs. A tolerance of 0.10 ppm is required for poultry, liver and 0.02 ppm for poultry meat byproducts (mbyp) (except liver). Higher tolerances for the indirect or inadvertent residues of methoxyfenozide in or on vegetable, bulb, group; vegetable, root and tuber, group and vegetable, root and tuber, leaves, group at 0.20, 0.10, and 0.20 ppm respectively are required. Tolerances for the indirect or inadvertent residues of methoxyfenozide in or on leafy and Brassica vegetables are not needed since direct tolerances are being established for them. Higher tolerances for the indirect or inadvertent combined residues of methoxyfenozide benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide and its metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-dimethylbenzoic acid N -tert-butyl- N '-(3-hydroxy-2-methylbenzoyl) hydrazide], RH-151,055 [glucose conjugate of RH-117,236; 3,5-dimethyl benzoic acid N -tert-butyl- N -[3 ( β -D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate of RH 117,236 in or on animal feed, non-grass (forage, fodder, straw, hay), group; grain, cereal, forage, fodder, and straw, group; grass, forage, fodder, and hay, group; herbs and spices, group; vegetable, legume, group; and vegetable, legume, foliage, group at 10.0 ppm, 10.0 ppm, 10.0 ppm, 10.0 ppm, 0.10 ppm and 10.0 ppm respectively are needed.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for residues of the insecticide methoxyfenozide in or on almond, hulls; artichoke, globe; cattle, fat; corn, field, grain; corn, field, forage; corn, field, stover; corn, oil; corn, aspirated grain fractions; corn, sweet (K + CWHR); corn, sweet, forage; corn, sweet, stover; fruit, stone, group (except plum, fresh prune); goat, fat; grape; horse, fat; lime, Spanish; longan; lychee; milk; nut, tree, group; pistachio; plum (fresh prune); poultry, fat; poultry, meat; pulasan; raisin; rambutan; sheep, fat; vegetable, fruiting (except cucurbits), group; vegetable, leafy (except Brassica), leafy greens subgroup; vegetable, leafy (except Brassica), leaf petioles subgroup; vegetable, leafy, Brassica (cole), head and stem subgroup; vegetable, leafy, Brassica (cole), greens subgroup at 25.0, 3.0, 0.50, 0.05, 15.0, 125.0, 0.20, 2.0, 0.05, 30.0, 60.0, 3.0, 0.50, 1.0, 0.50, 2.0, 2.0, 2.0, 0.10, 0.10, 0.10, 0.30, 0.02, 0.02, 2.0, 1.5, 2.0, 0.5, 2.0, 30.0, 25.0, 7.0 and 30.0 ppm respectively, and for the combined residues of methoxyfenozide and its glucuronide metabolite in or on cattle, liver; cattle, meat byproducts (except liver); eggs; goat, liver; goat meat byproducts (except liver); horse, liver; horse, meat byproducts (except liver); poultry, liver; poultry, meat byproducts (except liver); sheep, liver; and sheep, meat byproducts (except liver) at 0.40, 0.10, 0.02, 0.40, 0.10, 0.40, 0.10, 0.10, 0.02, 0.40 and 0.10 ppm, respectively. EPA also has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for the indirect or inadvertent residues for methoxyfenozide in or on vegetable, bulb, group; vegetable, root and tuber, group; and vegetable, root and tuber, leaves, group when present therein as a result of the application of methoxyfenozide to growing crops at 0.20, 0.10 and 0.20 ppm, respectively and time-limited indirect or inadvertent combined residues for methoxyfenozide and its metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-dimethylbenzoic acid N -tert-butyl- N '-(3-hydroxy-2-methylbenzoyl) hydrazide], RH-151,055 glucose conjugate of RH-117,236; 3,5-dimethylbenzoicacid N -tert-butyl- N -[3( β -D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate of RH-117,236 in or on animal feed, non-grass (forage, fodder, straw, hay), group; grain, cereal, forage, fodder, and straw, group; grass, forage, fodder, and hay, group; herbs and spices, group; vegetable, legume, group; and vegetable, legume, foliage, group when present therein as a result of the application of methoxyfenozide to growing crops at 10.0, 10.0, 10.0, 10.0, 0.10 and 10.0 ppm, respectively. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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

In an acute neurotoxicity study in rats (MRID 44617802), statistically significant decreased hindlimb grip strength was observed in male rats at 3 hours (approximate time of peak effect) following a single oral dose of 2,000 milligrams/kilogram (mg/kg) (limit dose) of methoxyfenozide. Decreased hindlimb grip strength was also observed in the male rats at 7 and 14 days, but was not statistically significant. No other systemic or neurotoxic effects were observed in the male rats or in the female rats at any time in this study. Since this marginal effect occurred only in one sex, was statistically significant at only one time, was observed only at the high dose (limit dose) and no other signs of toxicity were observed in the rats in this study, this possible effect is not considered to be biologically significant. In addition, neither decreased hindlimb grip strength nor any other signs of neurotoxicity were observed in any of the animals at any time in a 90-day subchronic neurotoxicity study in rats (MRID 44617803).

In a 2-week range-finding dietary study in rats (MRID 44617722), treatment-related effects were observed at ≥ 5,000 ppm in the liver (increased liver weights and hepatocellular hypertrophy in males and females), in the thyroid gland (hypertrophy/hyperplasia of follicular cells in males and females), and in the adrenal gland (increased adrenal weights and/or hypertrophy of the zona fasciculata in females). Hypertrophy/hyperplasia of thyroid follicular cells was also observed in males and females at 1,000 ppm, the LOAEL in this study. The NOAEL was 250 ppm. Treatment-related hematological changes were not observed in the rats in this study.

In a 3-month feeding study in rats (MRID 44617722), the predominant treatment-related effects were increased liver weights in males and females and periportal hepatocellular hypertrophy in all males and females at 20,000 ppm (highest dose tested) and at 5,000 ppm. In addition, at 20,000 ppm, a slightly decreased (7-8%) red blood cell (RBC) count and slightly decreased (7-8%) hemoglobin concentration, compared to control rats, were observed in the females. The LOAEL in this study was 5,000 ppm (353 mg/kg/day in males and 379 mg/kg/day in females). The NOAEL was 1,000 ppm (69 mg/kg/day in males and 72 mg/kg/day in females). Although observed in the 2-week dietary study and in the 2-year chronic feeding/carcinogenicity study in rats, treatment-related effects in the thyroid and adrenal glands were not observed in the rats in this 3-month study. There is no available biological explanation for this difference in findings in the studies.

In a 2-year combined chronic feeding/carcinogenicity study in rats (MRID 44617731), the following treatment-related effects were observed at 20,000 ppm (highest dose tested): decreased survival in males, decreased body weight and food efficiency in females during the last year of the study, hematological changes (decreased RBC counts, hemoglobin concentrations, and/or hematocrits; methemoglobinemia; and increased platelet counts) in males and females, increased liver weights and periportal hepatocellular hypertrophy in males and females, thyroid follicular cell hypertrophy in males, altered thyroid colloid in males and females, and increased adrenal weights in males and females. At 8,000 ppm, the following treatment-related effects were observed: hematological changes (decreased RBC counts, hemoglobin concentrations, and/or hematocrits in males and females), liver toxicity (increased liver weights in males and periportal hepatocellular hypertrophy in males and females), histopathological changes in the thyroid (increased follicular cell hypertrophy in males and altered colloid in males) and possible adrenal toxicity (increased adrenal weights in males and females). The LOAEL in this study was 8,000 ppm (411 mg/kg/day in males and 491 mg/kg/day in females), based on the effects described above. The NOAEL was 200 ppm (10.2 mg/kg/day in males and 11.9 mg/kg/day in females). This NOAEL was used to establish the RfD for methoxyfenozide. Utilizing an uncertainty factor (UF) of 100 to account for both interspecies extrapolation (10X) and intraspecies variability (10X), the chronic RfD for methoxyfenozide was calculated to be 0.10 mg/kg/day. No evidence of carcinogenicity was observed in this study. Dosing was considered adequate because of the decreased survival in males and the decreased body weights and food efficiency in females at 20,000 ppm. In addition, the highest dose tested for both males and females, 20,000 ppm (1,045 mg/kg/day males and 1,248 mg/kg/day in females), is higher than the limit dose of 1,000 mg/kg/day.

In a 2-week range-finding study in dogs (MRID 44617724), treatment- related hematological changes were observed in both males and females at 3,500 ppm, 7,000 ppm, 15,000 ppm and 30,000 ppm (highest dose tested). These changes included decreased RBC counts, decreased hemoglobin concentrations, decreased hematocrits, decreased MCHC, increased MCV, increased MCH, increased Heinz bodies, methemoglobinemia, changes in RBC morphology such as Howell-Jolly bodies and polychromasia, increased reticulocyte counts, increased nucleated RBC and increased platelet counts. At the same dose levels ( ≥ 3,500 ppm), increased spleen weights and/or enlarged spleens were also observed. At ≥ 7,000 ppm, plasma total bilirubin was increased. The LOAEL in this study was 3,500 ppm (90-184 mg/kg/day in males and females). The NOAEL was 300 ppm (11-16 mg/kg/day in males and females).

In a 3-month feeding study in dogs (MRID 44617724), no treatment-related effects other than a suggestion of decreased body weight gains in males and females were observed in either males or females at the highest dose tested viz. 5,000 ppm (198 mg/kg/day in males and 209 mg/kg/day in females). Although hematological effects were noted in dogs in the 2-week range-finding study at ≥ 3,500 ppm (90-184 mg/kg/day) and in the 1-year chronic feeding study at ≥ 3,000 ppm (106 mg/kg/day in males and 111 mg/kg/day in females), hematological changes were not observed in this 3-month study at 5,000 ppm (198/209 mg/kg/day). There is no available biological explanation for this difference in findings in the studies.

As part of the 3-month study in dogs (MRID 44617724), some male and female dogs were given 15 ppm (0.6 mg/kg/day) of methoxyfenozide in the diet for 15 weeks followed by an increase in the dietary dose to 15,000 ppm (422 mg/kg/day in males and 460 mg/kg/day in females) for an additional 6 weeks. After about 2 weeks and 6 weeks at 15,000 ppm, hematological examinations were conducted. No hematological changes in these dogs were observed. Apparently, pretreatment of the dogs at 15 ppm for 15 weeks prevented the occurrence of hematological changes which would have been expected to occur based on results in the 2-week and 1-year feeding studies. One possible explanation is that the liver microsomal enzyme system may have been stimulated so much during pretreatment at 15 ppm that the metabolic (detoxification ?) rate of methoxyfenozide was increased to the point where blood levels of methoxyfenozide may have remained below critical effect levels at 15,000 ppm. Another possible explanation is that compensatory mechanisms for replacing damaged RBC in pretreated dogs may have been so efficient that hematological changes were not observed in these dogs even at 15,000 ppm. Other explanations for this finding are also possible.

In a 1-year chronic feeding study in dogs (MRID 44617728), the predominant toxic effects were anemia and signs of an associated compensatory response. At 30,000 ppm, the highest dose tested, the following treatment-related effects were observed in both males and females: decreased RBC counts, decreased hemoglobin concentrations, decreased hematocrits, methemoglobinemia, nucleated RBC, increased platelets, increased serum total bilirubin, bilirubinurea, increased hemosiderin in macrophages in liver and spleen, and increased hyperplasia in bone marrow of rib and sternum. Increased liver weights in males and females and increased thyroid weights in males were also observed at 30,000 ppm. Signs of anemia were also noted at 3,000 ppm and included decreased RBC counts, decreased hemoglobin concentrations, decreased hematocrits, methemoglobinemia, increased platelets, and increased serum total bilirubin and bilirubinurea. The LOAEL in this study was 3,000 ppm (106 mg/kg/day in males and 111 mg/kg/day in females). The NOAEL was 300 ppm (9.8 mg/kg/day in males and 12.6 mg/kg/day in females).

In a 3-month feeding study in mice (MRID 44617723), the only treatment-related effect was decreased body weight gain in males and females at 7,000 ppm, the highest dose tested. The LOAEL in this study was 7,000 ppm (1,149 mg/kg/day in males and 1,742 mg/kg/day in females) and the NOAEL was 2,500 ppm (428 mg/kg/day in males and 589 mg/kg/day in females). In an 18-month carcinogenicity study in mice (MRID 44617729), no treatment-related effects were observed at doses up to and including the limit dose of 7,000 ppm (1,020 mg/kg/day in males and 1,354 mg/kg/day in females). No evidence of carcinogenicity was observed in this study. Dosing was considered adequate because the highest dose tested for both males and females, 7,000 ppm (1,020 mg/kg/day in males and 1,354 mg/kg/day in females, respectively), is higher than the limit dose of 1,000 mg/kg/day.

In a battery of four mutagenicity studies (with and without metabolic activation, as appropriate for the specific study), technical grade methoxyfenozide was negative for genotoxicity in all four studies. The four studies satisfy the new revised mutagenicity guideline requirements for a new chemical (published in 1991). An additional mutagenicity study, performed on RH-117,236 (Metabolite M-B), a metabolite of methoxyfenozide, was also negative for genotoxicity.

Based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies, methoxyfenozide is classified as a “not likely” human carcinogen according to the EPA Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996).

In a developmental toxicity study in rats (MRID 44638201), no signs of maternal toxicity in dams or of developmental toxicity in fetuses were observed at the limit dose of 1,000 mg/kg/day. The NOAEL in this study for both maternal toxicity and developmental toxicity was 1,000 mg/kg/day. The LOAEL was > 1,000 mg/kg/day. Similarly, in a developmental toxicity study in rabbits (MRID 44617726), no signs of maternal toxicity or of developmental toxicity were observed at the limit dose of 1,000 mg/kg/day. The NOAEL in this study for both maternal toxicity and developmental toxicity was 1,000 mg/kg/day. The LOAEL was > 1,000 mg/kg/day.

In neither the developmental toxicity study in rats nor in the developmental toxicity study in rabbits was there any evidence for increased susceptibility of fetuses to in utero exposure to methoxyfenozide. In these studies, methoxyfenozide was determined not to be a developmental toxicant.

In a 2-generation (1 litter/generation) reproduction study in rats (MRID 44617727), treatment-related parental toxicity was observed only at 20,000 ppm, the highest dose tested. At this dose, increased liver weights were observed in males and females of both generations and midzonal to periportal hepatocellular hypertrophy was observed in the livers of all males and females of both generations. The LOAEL for parental toxicity was 20,000 ppm (1,552 mg/kg/day for males and 1,821 mg/kg/day for females) and the NOAEL was 2,000 ppm (153 mg/kg/day for males and 181 mg/kg/day for females). There were no treatment-related effects on reproductive parameters for adult (parent) animals. The NOAEL for reproductive toxicity was 20,000 ppm. Since no treatment-related effects were observed in the pups, the NOAEL for neonatal toxicity was also 20,000 ppm. The NOAEL for parental toxicity in this reproduction study is higher than the NOAEL for the 2-year combined chronic feeding/carcinogenicity study in rats because many of the toxic effects observed in the 2-year study at the LOAEL (hematological changes, liver toxicity, histopathological changes in the thyroid gland and increased adrenal weights) were not examined in the reproduction study.

In a metabolism study in rats (MRID 44617804), 14 C-methoxyfenozide was rapidly absorbed, distributed, metabolized and almost completely excreted within 48 hours. The major route of excretion was feces (86-97%) with lesser amounts in the urine (5-13%). An enterohepatic circulation was observed. The test material was metabolized principally by O-demethylation of the A-ring methoxy group and oxidative hydroxylation of the B-ring methyl groups followed by conjugation with glucuronic acid. No significant sex-related or dose-dependent differences in metabolic disposition were noted. Seven metabolites and the parent accounted for 74-90% of the administered dose in all groups. The glucuronide conjugates are considered to be less toxic than the parent compound because glucuronide conjugation is well known to be a commonly occurring “detoxification” mechanism in mammalian species since it results in the formation of more polar, more water-soluble metabolites which are readily and easily excreted from the body (in this case, in the bile and urine). Further, based on similarities of chemical structure, the non-conjugated metabolites would be expected to be no more toxic than the parent compound.

In a dermal absorption study in rats (MRID 44638201) using an 80% wettable powder formulation as the test material, the cumulative dermal absorption of test material after a 10 or 24 hour dermal exposure was determined to be 2%.

In a 28-day dermal toxicity study in rats (MRID 44617725), no treatment-related systemic or skin effects were observed at the limit dose of 1,000 mg/kg/day (HDT).

Regarding effects on endocrine organs, methoxyfenozide affected the thyroid gland and adrenal gland in the 2-week and 2-year feeding studies in rats. In the thyroid gland, hypertrophy/hyperplasia of follicular cells and altered colloid were observed in males and females at or near the LOAEL in both of these studies. In the adrenal gland, increased adrenal weights and hypertrophy of the zona fasciculata were also observed in males and females at or near the LOAEL. In addition, in the 1-year chronic feeding study in dogs, increased thyroid weight in males was observed, but only at the very high dose of 30,000 ppm. Other than the morphological changes described above, there were no signs of thyroid or adrenal dysfunction in these or in any other studies on methoxyfenozide.

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for methoxyfenozide used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.544) for the residues of methoxyfenozide, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from methoxyfenozide 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. No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on methoxyfenozide. Thus, the risk from acute exposure is considered negligible.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments:

a. A tier 1( assumptions: tolerance level residues and 100 percent crop treated ) was conducted.

b. The established tolerances of 40 CFR 180.544 and the new tolerances established today were included in the analysis.

c. Anticipated residues and percent crop treated were not used in this analysis.

d. The processing factors applied were the DEEM default values.

As shown in table 2 of this preamble, the resulting dietary food exposures occupy up to 34.3% of the Chronic PAD for the most highly exposed population subgroup, children, 1-6 years old. These results should be viewed as conservative (health protective) risk estimates. Refinements such as use of percent crop-treated information and/or anticipated residue values would yield even lower estimates of chronic dietary exposure.

iii. Cancer . Methoxyfenozide is classified as a “not likely” human carcinogen. Therefore this risk is considered negligible.

iv. Anticipated residue and percent crop treated information . Anticipated residue and percent crop treated information was not used in the Agency's assessment.

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

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

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

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

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of methoxyfenozide for acute exposures are estimated to be 290 parts per billion (ppb) for surface water and 12 ppb for ground water. The EECs for chronic exposures are estimated to be 197 ppb for surface water and 12 ppb for ground water.

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

Methoxyfenozide is not registered for use on any sites that would result in residential exposure.

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

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

1. In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database 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. Prenatal and postnatal sensitivity . The toxicology database for methoxyfenozide included acceptable developmental toxicity studies in both rats and rabbits as well as a 2-generation reproductive toxicity study in rats. The data provided no indication of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to methoxyfenozide.

3. Conclusion . The 10X safety factor for the protection of infants and children (as required by FQPA) has been removed (i.e. reduced to 1x) for the following reasons:

• The toxicology data base for methoxyfenozide is complete for assessment of potential hazard to infants and children.

• Based on weight-of-the-evidence considerations, the HIARC determined that a developmental neurotoxicity study in rats is not required to support the registration of methoxyfenozide.

• In developmental toxicity studies in rats and rabbits (MRID 44638201, 44617726), no increased susceptibility in fetuses as compared to maternal animals was observed following in utero exposures.

• In a 2-generation reproduction study in rats (MRID 44617727), no increased susceptibility in pups as compared to adults was observed following in utero and post-natal exposures.

• The exposure assessments will not underestimate the potential dietary (food and drinking water) or non-dietary exposures for infants and children from the use of methoxyfenozide.

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

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

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

1. Acute risk . No appropriate toxicological endpoint attributable to a single (acute) dietary exposure was identified. No acute risk is expected from exposure to methoxyfenozide.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to methoxyfenozide from food will utilize 18.7% of the cPAD for the U.S. population, 24.6% of the cPAD for non-nursing infants and 34.3% of the cPAD for children (1-6 years old). There are no residential uses for methoxyfenozide that result in chronic residential exposure to methoxyfenozide. In addition, there is potential for chronic dietary exposure to methoxyfenozide in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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).

Methoxyfenozide is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

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

Methoxyfenozide is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . Methoxyfenozide is classified as a “not likely” human carcinogen. Therefore, exposure to methoxyfenozide is expected to create at most a negligible risk of cancer.

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 methoxyfenozide residues.

1. Enforcement methods for target crops. Adequate enforcement methods are available for determination of methoxyfenozide residues in plant commodities. The similar methods that are used vary depending on the matrices involved. The enforcement method for cottonseed is TR 34-96-88 (high production liquid chromatography using ultraviolet detection (HPLC/UV); MRID 44617821), which has undergone a successful petition method validation (PMV) trial conducted by EPA (D261663). The enforcement method for pome fruit (also proposed for globe artichoke and lychee) is TR 34-98-87 (HPLC/UV; MRID 44626304), which has also undergone a successful PMV trial conducted by EPA (D261664). The other proposed enforcement methods are on: corn, TR 34-00-38 (HPLC/UV; MRID 45213504); tree nuts, TR 34-00-107 (HPLC/UV; MRID 45373503); stone fruit, TR 34-00-109 (HPLC/UV; MRID 45313302); leafy and Brassica (cole) vegetables, fruiting vegetables, grapes and raisins, TR 34-99-74 (HPLC/UV or MS; MRID 44873410). Adequate confirmatory method validation, radiovalidation, and independent laboratory validation (ILV) data for these methods have been provided.

2. Enforcement method for rotational crops. Method TR 34-00-41(MRID 45194701) is designated as the enforcement method for indirect or inadvertent residues in rotational crops (D269986). The method determines residues of methoxyfenozide (HPLC/UV) in high moisture crops; and residues of methoxyfenozide and its metabolites RH-117,236, RH-151,055, and RH-152,072 (HPLC/MS) in low moisture crops. Adequate confirmatory method validation, radiovalidation, and ILV data have been submitted. EPA concluded (D274209) a PMV trial on this method was not needed because of its similarity to TR 34-98-87.

3. Enforcement methods for animal commodities. The tolerance enforcement method for animal commodities (except poultry) is TR 34-98-106 (MRID 44626305), which has undergone a successful PMV trial conducted by EPA (D261665). The method determines residues of parent methoxyfenozide (HPLC/UV) in fat, cream, milk, and muscle;and residues of methoxyfenozide and its metabolite RH-141,518 (HPLC/MS) in liver and kidney (D249438). A similar method, TR 34-00-40 (MRID 45213505), will be the enforcement method for poultry commodities. TR 34-00-40 determines methoxyfenozide in fat (HPLC/UV) and muscle (HPLC/MS);and methoxyfenozide and RH-141,518 (HPLC/MS) in eggs and liver (D269969). EPA concluded (D274209) a PMV trial on this method was not needed because of its similarity to TR 34-98-106. Adequate confirmatory method validation, radiovalidation, and ILV data have been submitted for both methods.

4. Multiresidue methods testing. Methoxyfenozide is not recoverable by the Food and Drug Administration multiresidue method protocols of the Pesticide Analytical Method, Volume I (D249438). Test data for metabolites RH-141,518, RH-117,236, RH-151,055, and RH-152,072 are also required, but have not been submitted. Submission of such test data will be made a condition of registration.

These methods may be requested from: Calvin Furlow, PIRIB, Information Resources and Services Division (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 or Canadian MRLs established for residues of methoxyfenozide. Mexican MRLs are established for residues of methoxyfenozide in cottonseed (0.05 ppm) and maize (0.01 ppm). The U.S. tolerances on these commodities are 2.0 ppm and 0.05 ppm, respectively. Based on the current use patterns, the U.S. tolerance levels can not be reduced to harmonize with the Mexican MRLs, so incompatibility will exist.

Submission of test data showing the recovery of metabolites RH-141,518, RH-117,236, RH-151,055, and RH-152,072 through the multiresidue test protocols of PAM, Vol. 1.

Submission of additional field accumulation trials (the 24 reportedly in progress). In the interim period, only time-limited tolerances (5 year) should be established.

• Submission of the following additional field trials, conducted per their respective proposed use pattern:

• Three for spinach (one each from Regions 1, 2, and 10)

• Two for celery (both from Region 3, preferably using Intrepid 2F)

• Three for mustard greens (one each from Regions 2, 3, and 10)

• Two for plums (one each from Regions 10 and 11)

Submission of the following additional information from the hen feeding study:

• Results of analysis (to be conducted) of the fat and meat (muscle) samples for residues of RH-141,518;

• Freezer storage stability data that covers the period of time these poultry fat and meat (muscle) samples have been maintained in storage;and,

• Revised tolerances and tolerance expression (to include RH 141,518) for these matrices, if warranted.

Therefore, tolerances are established for residues of the insecticide methoxyfenozide in or on almond, hulls; artichoke, globe; cattle, fat; corn, field, grain; corn, field, forage; corn, field, stover; corn, oil; corn, aspirated grain fractions; corn, sweet (K + CWHR); corn, sweet, forage; corn, sweet, stover; fruit, stone, group (except plum, fresh prune); goat, fat; grape; horse, fat; lime, Spanish; longan; lychee; milk; nut, tree, group; pistachio; plum (fresh prune); poultry, fat; poultry, meat; pulasan; raisin; rambutan; sheep, fat; vegetable, fruiting (except cucurbits), group; vegetable, leafy (except Brassica), leafy greens subgroup; vegetable, leafy (except Brassica), leaf petioles subgroup; vegetable, leafy, Brassica (cole), head and stem subgroup; vegetable, leafy, Brassica (cole), greens subgroup at 25.0, 3.0, 0.50,0.05, 15.0, 125.0, 0.20, 2.0, 0.05, 30.0, 60.0, 3.0, 0.50, 1.0,0.50, 2.0,2.0, 2.0 0.10, 0.10,0.10,0.30, 0.02, 0.02, 2.0, 1.5, 2.0, 0.5, 2.0, 30.0, 25.0, 7.0 and 30.0 part per million (ppm) respectively and for the combined residues of methoxyfenozide and its glucuronide metabolite in or on cattle, liver; cattle, meat byproducts (except liver); eggs; goat, liver; goat meat byproducts (except liver); horse, liver; horse, meat byproducts (except liver); poultry, liver; poultry, meat byproducts (except liver); sheep, liver; and sheep, meat byproducts (except liver) at 0.40, 0.10, 0.02, 0.40, 0.10, 0.40, 0.10, 0.10, 0.02, 0.40 and 0.10 part per million (ppm) respectively. These petitions also requested that 40 CFR 180.544 be amended by establishing time limited tolerances for the indirect or inadvertent residues for methoxyfenozide in or on vegetable, bulb, group; vegetable, root and tuber, group; and vegetable, root and tuber, leaves, group when present therein as a result of the application of methoxyfenozide to growing crops at 0.20, 0.10 and 0.20 part per million (ppm) respectively and time limited indirect or inadvertent combined residues for methoxyfenozide and its metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-dimethylbenzoic acid N -tert-butyl- N '-(3-hydroxy-2-methylbenzoyl) hydrazide, RH-151,055 glucose conjugate of RH-117,236; 3,5-dimethylbenzoicacid N -tert-butyl- N -[3( β -D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate of RH 117,236 in or on animal feed, non-grass (forage, fodder, straw, hay), group; grain, cereal, forage, fodder, and straw, group; grass, forage, fodder, and hay, group; herbs and spices, group; vegetable, legume, group; and vegetable, legume, foliage, group when present therein as a result of the application of methoxyfenozide to growing crops at 10.0, 10.0, 10.0, 10.0, 0.10 and 10.0 part per million (ppm) respectively.

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 ID number OPP-2002-0219 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 November 19, 2002.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0219, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

This is a summary of the Commission's Third Report and Order in CC Docket Nos. 96-115 and 96-149, adopted July 16, 2002, and released July 25, 2002. The complete text of this Report and Order is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC, 20554. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail at qualexint@aol.com . It is also available on the Commission's Web site at http://www.fcc.gov .

1. The Commission resolves in this Order several issues in connection with carriers' use of customer proprietary network information (“CPNI”) pursuant to section 222 of the Telecommunications Act of 1996. Through section 222, Congress recognized both that telecommunications carriers are in a unique position to collect sensitive personal information and that customers maintain an important privacy interest in protecting this information from disclosure and dissemination. The rules adopted by the Commission focus on the nature of the customer approval needed before a carrier can use, disclose or permit access to CPNI.

2. Background. This proceeding was initiated in 1996 to implement section 222 of the Communications Act of 1934 (as amended), which governs carriers' use and disclosure of CPNI. On February 26, 1998, the Commission adopted regulations implementing section 222 in its CPNI Order . [63 FR 20236, April 24, 1998]. In particular, it concluded that section 222(c)(1) of the Act allows a carrier to use a customer's CPNI, derived from the complete service subscribed to from that carrier, for marketing purposes within the existing service relationship. This is known as the “total service approach.” The Commission also concluded that carriers must notify the customer of the customer's rights under section 222 and then obtain express written, oral or electronic customer approval—a “notice and opt-in” approach—before a carrier may use CPNI to market services outside the customer's existing service relationship with that carrier. On September 3, 1999, the Commission released an Order on Reconsideration [64 FR 53242, Oct. 1, 1999] that affirmed the opt-in approach, but streamlined the CPNI rules so that carriers could use CPNI to market customer premises equipment and information services without customer approval, and lessened carriers' CPNI record-keeping responsibilities. It also eliminated restrictions on a carrier's ability to use CPNI to regain customers that switched to another carrier, known as “winbacks.”

3. After the Commission adopted the Order on Reconsideration , but prior to its release, the Court of Appeals for the Tenth Circuit vacated portions of the 1998 CPNI Order . The court found that the Commission did not show that the opt-in form of consent protected privacy and promoted competition in a manner consistent with the First Amendment of the U.S. Constitution.

4. In an October 6, 2000 Order, AT&T v. Bell Atlantic (denying a complaint by AT&T regarding the manner in which Bell Atlantic markets the services of its long distance affiliate to its local exchange customers), the Commission interpreted the Tenth Circuit's vacatur as applying only to the discrete issue that was before the court. On September 7, 2001, the Commission released a Clarification Order and Second Further Notice of Proposed Rulemaking [66 FR 50140, Oct. 2, 2001] that determined that all CPNI rules except those relating to opt-in remained in effect, and that carriers may choose to obtain customer approval by means of an opt-out approach until the Commission adopted final rules. This Order sought comment on adopting either an opt-in or opt-out approach.

5. On July 16, 2002, the Commission adopted a Third Report and Order that allows a carrier to choose whether to use an opt-out or opt-in approval method for obtaining customer approval for a carrier to use its customer's individually identifiable CPNI for the purpose of marketing communications-related services to that customer. The Order allows a carrier—subject to opt-out or opt-in approval—to disclose its customer's individually identifiable CPNI, for the purpose of marketing communications-related services to that customer, to (i) Its agents, (ii) its affiliates that provide communications-related services, and (iii) its joint venture partners and independent contractors. Carriers must obtain opt-in customer approval for all other uses and disclosures of CPNI to which other exceptions do not apply.

6. Discussion. This document allows carriers to choose the method(s) by which consumers may express their opt-out or opt-in choices. However, carriers are required to make available to all customers a method to opt-out that is of no cost to the customer and that is available 24 hours a day, seven days a week. This document confirms the previous determination that preferred carrier freezes (PC freezes) fit within the statutory definition of CPNI, and forbears from imposing the affirmative approval requirements in the CPNI rules so that preferred carrier freeze information can be disclosed among carriers.

7. This Order contains new and modified information collections subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget (OMB) for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new or modified information collection(s) contained in this proceeding. Implementation of these new or modified reporting and/or recordkeeping requirements will be subject to approval by the OMB, as prescribed by the Act, and will go into effect upon announcement in the Federal Register of OMB approval.

8. As required by the Regulatory Flexibility Act, as amended, (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Clarification Order and Second Further Notice of Proposed Rulemaking issued in CC Docket No. 96-115 and CC Docket No. 96-149. The Commission sought written public comment on the proposals in the Second FNPRM, including comment on the IRFA. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

9. The initial need for the proceeding of which this Report and Order is a part is that on May 17, 1996, the Commission initiated a rulemaking in response to requests for guidance from the telecommunications industry regarding the obligations of telecommunications carriers under section 222 of the Act and related issues. The Commission released the CPNI Order on February 26, 1998, in which it addressed the scope and meaning of section 222 and promulgated implementing regulations. On August 18, 1999, the Tenth Circuit issued an opinion vacating a portion of the CPNI Order in U S WEST v. FCC. That left the Commission with a need to clarify the CPNI rules and their future operation. The Commission does so herein.

10. On August 28, 2001, the Commission adopted an order (CPNI Clarification Order) clarifying the status of its CPNI rules in light of the Tenth Circuit order and issuing a Further Notice of Proposed Rulemaking (Clarification Order Further NPRM) . Specifically, the Commission sought comment on (1) Its interpretation of the scope of the Tenth Circuit order; (2) what type of approval (opt-in or opt-out) would best serve the government's goals while respecting constitutional limits; (3) ways in which consumers can consent to a carrier's use of their CPNI; (4) what methods of approval would serve the governmental interests at issue and afford informed consent, while also satisfying the First Amendment's requirement that any restrictions on speech be narrowly tailored; (5) the interests and policies underlying section 222 that are relevant to formulating an approval requirement, including an analysis of the privacy interests that are at issue, and on the extent to which it should take competitive concerns into account; (6) the likely difference in competitive harms under opt-in and opt-out approvals; and (7) whether adoption of an opt-out mechanism is consistent with the rationale for the total service approach set forth in the CPNI Order. In addition, the Commission sought comment on whether its consent mechanism would affect its previous findings on the interplay between sections 222 and 272.

11. In this Order, the Commission reaches the objective of resolving several issues in connection with carriers' use of customer proprietary network information pursuant to section 222 of the Telecommunications Act of 1996. In formulating the required approval mechanism described below, we carefully balance carriers' First Amendment rights and consumers' privacy interests so as to permit carriers flexibility in their communications with their customers while providing the level of protection to consumers' privacy interests that Congress envisioned under section 222.

12. More specifically, The Commission adopts an approach that comports with the decision of the United States Court of Appeals for the Tenth Circuit vacating the Commission's requirement that carriers obtain express customer consent for all sharing between a carrier and its affiliates, as well as unaffiliated entities. The Commission adopts today an approach that is derived from a careful balancing of harms, benefits, and governmental interests. First, use of CPNI by carriers or disclosure to their affiliated entities providing communications-related services, as well as third-party agents and joint venture partners providing communications-related services, requires a customer's knowing consent in the form of notice and “opt-out” approval. Second, disclosure of CPNI to unrelated third parties or to carrier affiliates that do not provide communications-related services requires express customer consent, described as “opt-in” approval. Finally, the Commission reaffirms its “total services approach,” which permits the carrier to use CPNI to market new product offerings within the carrier-customer service relationship, on the basis of the customer's implied consent.

13. In this Order, the Commission also further refines the rules governing the process by which carriers provide notification to customers of their CPNI rights. Specifically, clarifying the form, content and frequency of carrier notices. In addition, although the Commission decline to reconsider its conclusion that customers' preferred carrier (PC) freeze information constitutes CPNI and thereby continue to accord it privacy protection pursuant to section 222, the Commission chooses to forbear from imposing the express consent requirements announced in this Order with respect to PC-freezes. Through its limited exercise of forbearance, the Commission balances customers' privacy concerns with carriers' meaningful commercial interests, resulting in PC-freeze information being made more readily available among competing carriers, consistent with the public interest. The Commission also affirms its previous determination that the word “information” in section 272 does not include CPNI, which is governed instead by section 222 of the Act.

14. Finally, the Commission accompanies this Order with a Further Notice of Proposed Rulemaking (“Further NPRM”) to refresh the record on two issues raised in the CPNI Order Further NPRM: foreign storage of and access to domestic CPNI, and CPNI safeguards and enforcement mechanisms. The Commission additionally requests comment on what, if any, appropriate regulations should govern the CPNI held by carriers that go out of business, sell all or part of their customer base, or seek bankruptcy protection.

15. One party, the Organization for the Promotion and Advancement of Small Telecommunications Companies (“OPASTCO”), commented specifically in response to the IRFA. OPASTCO argues that the IRFA was “deficient” for two reasons. First, OPASTCO notes that the IRFA “reverts to language which incorrectly suggests that small ILECs are not “small entities” under the Regulatory Flexibility Act.” Further, OPASTCO takes issue with the IRFA's determination that whatever consent rules are ultimately adopted will be applicable to all carriers. OPTASCO argues that “the Commission has not considered any alternatives, contrary to the requirements of 5 U.S.C. 603(c).”

16. The Commission confirms OPASTCO's assumption that the Clarification Order's IRFA did contain a clerical error regarding the classification of small ILECs. Accordingly, we affirm that Commission practice is to discuss small ILECs as “small entities” within our IRFAs, under the RFA. However, we note that no party was prejudiced or harmed by this error because the IRFA put potentially affected entities on notice by affirmatively stating that the Commission was “consider[ing] small ILECs within this analysis and us[ing] the term “small LECs” to refer to any ILECs that arguably might be defined by SBA as “small business concerns. ” Hence, the clerical error was cured in the very document in which it was alleged to be present.

17. OPASTCO's concern, therefore, that “if the rulemaking body itself has no preconceived idea of what the final rules might be, there is no way it can make the prejudgment that its final rules will be appropriate for all entities,” takes a statement from the IRFA out of context. Furthermore, OPASTCO's contention inaccurately describes the Commission's decision-making process and outcome in this proceeding.

18. First, although the Clarification Order did not propose specific consent requirements, the Clarification Order did “seek comment on ways in which carriers can obtain their customers' consent and the extent to which an opt-in or opt-out approach would satisfy both sections 222 and the Tenth Circuit's concerns that any restrictions on speech be no more than necessary to serve the asserted state interests.” Accordingly, although specific consent rules were not proposed, the only two potential types of consent (opt-in and opt-out) were explicitly mentioned and offered to interested parties for consideration and comment. In an instance such as this, where the Commission has previously considered what type of consent to require, and where the Order in question mentions the only two potential options for obtaining consent, it is unreasonable to claim that the Commission or any interested party had and has no idea what the final rules might be. Clearly, the Commission knew and adequately advised interested parties that the final rules would involve opt-in approval, opt-out approval, or some combination of the two. In fact, every commenter, including OPASTCO, focused extensively on whether the Commission should adopt opt-in or opt-out consent requirements. The Commission also notes that the IRFA went on to state that “[w]e have, however, taken the limited resources of small entities into account in promulgating certain existing CPNI rules, and intend to do so again in addressing the customer consent requirements.” The omission of ILECs, whether or not evidence of Commission oversight, is rendered moot by its inclusion of this statement.

19. Furthermore, the previously adopted opt-in approval rules were subject to, and complied with, the requirements of the RFA. Accordingly, the Commission has previously undertaken an analysis of opt-in and potential alternatives with respect to small carriers. Although such analysis does not supplant the analysis that the Commission must perform in this Order and in this FRFA, it provides meaningful guidance. In previous CPNI Orders, the Commission has received comment from several parties on the impact of proposed rules on small carriers. After extensive analysis, the Commission found that “[a]fter consideration of possible alternatives, we have concluded that our rules should apply equally to all carriers.” Thus any argument that the Commission ever neglected the interests of small carriers is thereby rendered invalid. The Commission's reasoning remains valid today. The Commission stated: “we are unpersuaded that customers of small businesses have less meaningful privacy interests in their CPNI.” Additionally, the weight added by Congressional intent is critical in this context and deserves comment. In drafting section 222, Congress determined that CPNI protections should apply to consumers of “[e]very telecommunications carrier.” Finally, the Commission notes that the rules it adopts today are less burdensome on all carriers, including small carriers, than the Commission's original opt-in rules.

20. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one that: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

21. The most reliable source of information regarding the total numbers of certain common carrier and related providers nationwide appears to be data the Commission publishes annually in its Telecommunications Provider Locator report, derived from filings made in connection with the Telecommunications Relay Service (TRS). According to data in the most recent report, there are 5,679 interstate service providers. These providers include, inter alia, local exchange carriers, wireline carriers and service providers, interexchange carriers, competitive access providers, operator service providers, pay telephone operators, providers of telephone service, providers of telephone exchange service, and resellers.

22. The Commission has included small incumbent local exchange carriers (ILECs) in this present RFA analysis. As noted above, a “small business” under the RFA is one that inter alia, meets the pertinent small business size standard ( e.g. , a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. The Commission therefore included small incumbent LECs in this RFA analysis, although it emphasizes that this RFA action has no effect on FCC analyses and determinations in other, non-RFA contexts.

23. Total Number of Telephone Companies Affected. The U.S. Bureau of Census (Census Bureau) reports that, at the end of 1992, there were 3,497 firms engaged in providing telephone services, as defined therein, for at least one year. This number contains a variety of different categories of carriers, including LECs, interexchange carriers, competitive access providers, operator service providers, pay telephone operators, and resellers. It seems certain that some of these 3,497 telephone service firms may not qualify as small entities or small incumbent LECs because they are not “independently owned and operated.” It seems reasonable to conclude that fewer than 3,497 telephone service firms are small entity telephone service firms that may be affected by these rules.

24. Wireline Carriers and Service Providers . The SBA has developed a definition of small entities for telephone communications companies other than radiotelephone (wireless) companies. The Census Bureau reports that there were 2,321 such telephone companies in operation for at least one year at the end of 1992. According to the SBA's definition, a small business telephone company other than a radiotelephone (wireless) company is one employing no more than 1,500 persons. All but 26 of the 2,321 non-radiotelephone (wireless) companies listed by the Census Bureau were reported to have fewer than 1,000 employees. Even if all 26 of the remaining companies had more than 1,500 employees, there would still be 2,295 non-radiotelephone (wireless) companies that might qualify as small entities or small incumbent LECs. Although it seems certain that some of these carriers are not independently owned and operated, the Commission is unable at this time to estimate with greater precision the number of wireline carriers and service providers that would qualify as small business concerns under SBA's definition. Therefore, the Commission estimates that fewer than 2,295 small telephone communications companies other than radiotelephone (wireless) companies are small entities that may be affected by these rules.

25. Local Exchange Carriers . Neither the Commission nor the SBA has developed a definition of small providers of local exchange services. The closest applicable definition under the SBA's rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the SBA's definition, a small business telephone company other than a radiotelephone (wireless) company is one employing no more than 1,500 persons. The most reliable source of information regarding the number of LECs nationwide of which the Commission is aware appears to be the data collected annually in connection with the Telecommunications Relay Service (TRS). According to the Commission's most recent data, there are 1,329 local exchange carriers, including incumbent LECs. Although it seems certain that some of these carriers are not independently owned and operated, or have more than 1,500 employees, the Commission is unable at this time to estimate with greater precision the number of LECs that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that they are fewer than 1, 329 small entity LECs that may be affected by the proposals in the Second Further Notice.

26. Interexchange Carriers . Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to providers of interexchange services (IXCs). The closest applicable definition under the SBA's rules is for telephone communications companies other than radiotelephone (wireless) companies. The most reliable source of information regarding the number of IXCs nationwide of which we are aware appears to be the data that the Commission collects annually in connection with TRS. According to its most recent data, 229 companies reported that they were engaged in the provision of interexchange services. Although it seems certain that some of these carriers are not independently owned and operated, or have more than 1,500 employees, the Commission are unable at this time to estimate with greater precision the number of IXCs that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that there are fewer than 229 small entity IXCs that may be affected by this order.

27. Competitive Access Providers . Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to providers of competitive access services (CAPs). The closest applicable definition under the SBA's rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the SBA's definition, a small business telephone company other than a radiotelephone (wireless) company is one employing no more than 1,500 persons. The most reliable source of information regarding the number of CAPs nationwide of which the Commission is are aware appears to be the data that it collect annually in connection with the TRS. According to the Commission's most recent data, 532 companies reported that they were engaged in the provision of either competitive access services or competitive local exchange service. Although it seems certain that some of these carriers are not independently owned and operated, or have more than 1,500 employees, the Commission is unable at this time to estimate with greater precision the number of CAPs that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that there are fewer than 532 small entity CAPs that may be affected by this order.

28. Operator Service Providers . Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to providers of operator services. The closest applicable definition under the SBA's rules is for telephone communications companies other than radiotelephone (wireless) companies. The most reliable source of information regarding the number of operator service providers nationwide of which the Commission is aware appears to be the data that it collects annually in connection with the TRS. According to the Commission's most recent data, 22 companies reported that they were engaged in the provision of operator services. Although it seems certain that some of these companies are not independently owned and operated, or have more than 1,500 employees, the Commission is unable at this time to estimate with greater precision the number of operator service providers that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that there are fewer than 22 small entity operator service providers that may be affected by this order.

29. Pay Telephone Providers . Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to pay telephone providers. The closest applicable definition under the SBA's rules is for telephone communications companies other than radiotelephone (wireless) companies. The most reliable source of information regarding the number of pay telephone operators nationwide of which the Commission is aware appears to be the data that it collects annually in connection with the TRS. According to the Commission's most recent data, 936 companies reported that they were engaged in the provision of pay telephone services. Although it seems certain that some of these carriers are not independently owned and operated, or have more than 1,500 employees, the Commission is unable at this time to estimate with greater precision the number of pay telephone operators that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that there are fewer than 936 small entity pay telephone operators that may be affected by this order.

30. Wireless Carriers . Wireless telephony includes cellular, personal communications services (PCS) or specialized mobile radio (SMR) service providers. The SBA has developed a definition of small entities for radiotelephone (wireless) companies; however, neither the Commission nor the SBA has developed a definition of small entities applicable to cellular licensees, or to providers of paging and messaging services. Though categorized under the same size standard as other wireless services discussed in this paragraph, paging is now considered a separate industry. The closest applicable definition under the SBA's rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the SBA's definition, a small business radiotelephone company is one employing no more than 1,500 persons. The Commission considers paging and messaging services to fall within this category. According to the most recent Provider Locator data, 858 carriers reported that they were engaged in the provision of wireless telephony and 576 companies reported that they were engaged in the provision of paging and messaging services. Although it seems certain that some of these carriers are not independently owned and operated, the Commission is unable at this time to estimate with greater precision the number of radiotelephone carriers and service providers that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that there are fewer than 858 small carriers providing wireless telephony services and fewer than 576 small companies providing paging and messaging services that may be affected by these rules.

31. Resellers . Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to resellers. The closest applicable definition under the SBA's rules is for all telephone communications companies. The most reliable source of information regarding the number of toll resellers nationwide of which the Commission is aware appears to be the data that it collects annually in connection with the TRS. According to the Commission's most recent data, 710 companies reported that they were engaged in the resale of telephone services. Although it seems certain that some of these carriers are not independently owned and operated, or have more than 1,500 employees, the Commission is unable at this time to estimate with greater precision the number of resellers that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that there are fewer than 710 small entity resellers that may be affected by this order.

32. In this Order, the Commission takes a number of steps that may affect small entities that use customers' CPNI outside of the total service approval or statutory exceptions in section 222. Some of the approval and notice requirements discussed herein will require additional reporting, recordkeeping or compliance requirements for service providers; however, certain approval and notice requirements discussed herein will also decrease certain reporting, recordkeeping or compliance requirements for service providers. The Commission believes that, overall, these new requirements will lessen the regulatory burden on small carriers by allowing carriers to obtain customers' consent through an opt-out approval mechanism to use customers' CPNI for marketing communications-related services.

33. This Order imposes the following additional reporting, recordkeeping or compliance requirements on all carriers. None of these requirements should affect small carriers disproportionately or require special professional skills. First, carriers must obtain opt-in CPNI approval for certain CPNI uses, and have the choice of obtaining opt-out or opt-in approval for other CPNI uses. As discussed in section III.C.1, supra, a carrier may determine whether to use one notice or multiple notices, and may request and provide notice relevant only to the CPNI uses the carriers proposes to make. Accordingly, if, as OPASTCO claims, its members only intend to use CPNI internally for marketing communications-related services, its member small carriers will only have to obtain opt-out approval from their customers.

34. Carriers who use opt-out approval must provide notice to their customers every two years. This requirement, while an added burden on all carriers, is counterbalanced by the fact that carriers who choose to use the opt-out method will be able to use and disclose more CPNI for marketing than under the opt-in method. Accordingly, a carrier that finds the burden of biennial notices to outweigh the benefit of expanded CPNI access can choose to obtain opt-in approval from its customers and avoid the biennial notice requirement. Additionally, notice requirements are common in the telecommunications industry and the requirements adopted here allow carriers flexibility in determining how to provide such notices. Accordingly, all carriers, including small carriers, should already have resources in place to provide notices required by such regulations to their customers.

35. The Commission requires carriers who use e-mail notices to advise their customers of their opt-out CPNI choices to abide by certain requirements. These requirements are not burdensome. To the degree that any carrier could seriously argue that these requirements are burdensome, carriers are not required to use e-mail to notify their customers of CPNI policies. Accordingly, a carrier can choose the least burdensome notification method allowed under our rules, based on the carrier's individual circumstances.

36. In addition, the Commission adds minor content requirements to our notice rules to synchronize the rules with the newly adopted consent requirements. These requirements should require minimal effort on the part of carriers, large and small, to implement. Furthermore, the Commission also streamlines the notice requirements for carriers to obtain limited, one-time use of consumers' CPNI for the duration of an inbound or outbound call with the customer, which will benefit small carriers.

37. The Commission adopts a 30-day minimum period of time that carriers must wait after giving customers' opt-out notice before assuming customer approval. Every carrier commenter supported the 30-day time period. Such a time period imposes minimal burden on carriers. This is especially true because the 30-day waiting period has been the interim rule since we adopted the CPNI Clarification Order and has been the subject of no carrier complaints or concerns.

38. The Commission adopts a requirement that carriers make available to every customer a method to opt-out that is of no additional cost and available 24 hours a day, seven days a week. This requirement can be satisfied through a combination of methods, so long as all customers have the ability to opt-out at no cost and are able to effectuate that choice whenever they choose. To the degree that carriers find that the burden of meeting this requirement outweigh the value of using an opt-out approval method, carriers are free to use opt-in. Carriers are otherwise free to determine what methods to use to allow customer to effectuate their CPNI elections. Although this requirement will impose a burden on small and large carriers alike, the Commission strongly believes that two factors mitigate against allowing small carriers to utilize less burdensome alternatives. First, as the Commission has previously held, there is nothing in this record that convinces it that customers of small carriers are entitled to lesser protection of the privacy of their calling records than those customers of larger carriers. Accordingly, it would be inappropriate to allow small carriers to provide less effective methods for customers to effectuate their CPNI choices. Second, to the degree that these requirements impose burdens on carriers, those burdens are outweighed by the value of using an opt-out approval mechanism to obtain customer approval to use CPNI for marketing communications-related services. Should carriers find that not to be the case in their individual situations, they can avoid the 24/7 requirement by adopting an opt-in approval mechanism.

39. The Commission forbears from applying our CPNI approval regulations to preferred carrier (“PC”) freezes, allowing small and large carriers alike easier access to PC-freeze information.

40. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.”

41. While the approval and related notice measures adopted in this Order apply similarly to both small and large entities, the Commission expects that small entities are likely to benefit to the extent such firms have fewer or reduced resources available, as compared to large firms. The Commission's previously adopted rules required all carriers to obtain opt-in approval from their customers to use CPNI outside of the total service approach. Although the Commission allowed carriers to use opt-out as an interim measure in light of the Tenth Circuit's opinion, that approach was never codified or adopted as a permanent rule. As discussed above, this Order adopts an approach that is derived from a careful balancing of harms, benefits, and governmental interests. First, use of CPNI by carriers or disclosure to their affiliated entities providing communications-related services, as well as third-party agents and joint venture partners providing communications-related services, requires a customer's knowing consent in the form of notice and “opt-out” approval. Second, disclosure of CPNI to unrelated third parties or to carrier affiliates that do not provide communications-related services requires express customer consent, described as “opt-in” approval. Finally, the Commission reaffirms its “total services approach,” which permits the carrier to use CPNI to market new product offerings within the carrier-customer service relationship, on the basis of the customer's implied consent.

42. Accordingly, the Commission concludes that the measures adopted and described in this Order would reduce regulatory burdens for small carriers including resellers, by allowing carriers access to CPNI for marketing communications-related services to their customers via an opt-out mechanism. Further, the Order specifically allows carriers to use opt-in approval for all CPNI uses should a carrier determine that opt-in is more appropriate for its individual circumstances, allowing carriers to make decisions regarding their customers and resources.

43. Furthermore, as noted above, the previously adopted opt-in rules were subject to and complied with the requirements of the RFA. Accordingly, the Commission has previously undertaken an analysis of opt-in and potential alternatives with respect to small carriers. Although such analysis does not replace the analysis that the Commission must perform in this Order, it provides meaningful guidance. In previous CPNI Orders, the Commission received comment from several parties on the impact of proposed rules on small carriers. After extensive analysis, the Commission found that “[a]fter consideration of possible alternatives, we have concluded that our rules should apply equally to all carriers.” The Commission's reasoning remains valid today. Of special importance in this context, the Commission's consistent determination, made throughout this proceeding, that “we are unpersuaded that customers of small businesses have less meaningful privacy interests in their CPNI.” This is especially true because, in drafting section 222, Congress determined that CPNI protections should apply to consumers of “[e]very telecommunications carrier.”

44. In this Order, the Commission also describes commenters' positions regarding other appropriate approval methods and related notice issues and states why those alternatives that the Commission does not adopt would not serve the public interest. For example, many carriers, including small carriers, proposed that we allow carriers to use opt-out approval for all CPNI uses. However, as it points out in this Order, the Commission must fulfill its statutorily imposed duty to protect consumers' CPNI, while balancing those interests with carriers' First Amendment interests. Therefore, as discussed in detail in the Order, the Commission concludes that the CPNI rules it adopts—which balance in an equitable fashion all consumers” privacy rights with carriers' First Amendment rights—strike the right balance for small and large carriers alike. Moreover, the Commission gains assurance from knowing that the rules it adopts benefit small carriers and serve the public interest by allowing carriers with expanded access to consumers' CPNI from its original opt-in rules.

45. Report to Congress . The Commission will send a copy of this Order, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act. In addition, the Commission will send a copy of this Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of this Order and FRFA (or summaries thereof) will also be published in the Federal Register .

46. Accordingly, it is ordered, pursuant to sections 1, 4(i), 222 and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 222 and 303(r ), that the Third Report and Order and Third Further Notice of Proposed Rulemaking in CC Docket Nos. 96-115, 96-149, and 00-257 are adopted , and that part 64 of the Commission's rules, 47 CFR part 64, is amended as set forth in the rule changes. The requirements of this Order shall become effective October 21, 2002, except §§ 64.2007, 64.2008, and 64.2009 which contain information collection requirements that have not been approved by OMB. The Commission will publish a document in the Federal Register announcing the effective date of these rules.

47. It is further ordered that the collection of information contained herein is contingent upon approval by the Office of Management and Budget.

48. It is further ordered that the California Public Utilities Commission's Motion to Accept Late-Filed Comments is hereby granted .

49. It is further ordered that, pursuant to sections 1, 4(i), 10 and 222 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 160 and 222, MCI WorldCom's Petition for Further Reconsideration is granted to the extent indicated herein and otherwise denied .

50. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Third Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 64 as follows:

This is a synopsis of the Report and Order in MM Docket No.01-62 adopted August 28, 2002, and released August 30, 2002. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals ll, CY-A257, 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone (202) 863-2893, facsimile (202) 863-2898, or via e-mail qualixint@aol.com .

This document reallots Channel 279C1 from Gadsden, Alabama, to Trussville, Alabama, and modifies the Station WQEN license to specify Trussville as its community of license. In order to allot Channel 279C1 to Trussville, Alabama, this documents reallots Channel 280C2 from Columbus, Mississippi, to Okolona, Mississippi, and modifies the Station WACR license to specify Okolona as its community of license. This document allots Channel 267A to Linden, Tennessee, and Channel 278A to New Hope, Alabama. This document substitutes Channel 279C3 for Channel 280A at McMinnville, Tennessee, reallots Channel 279C3 to Walden, Tennessee, and modifies the Station WTRZ license to specify operation Walden as its community of license. See 66 FR 14872, March 14, 2001. The reference coordinates for the Channel 288C2 allotment at Hoover, Alabama, are 33-22-41 and 86-48-35. The reference coordinates for the Channel 290C3 allotment at Brookwood, Alabama, are 33-12-36 and 87-24-40. The reference coordinates for the Channel 249A allotment at Winfield, Alabama, are 33-12-36 and 87-24-40. The reference coordinates for the Channel 289C0 allotment at Troy, Alabama, are 31-52-03 and 86-14-58. The reference coordinates for the Channel 280C2 allotment at Okolona, Mississippi, are 33-51-38 and 88-30-44. The reference coordinates for the Channel 258A allotment at Vardaman, Mississippi, are 33-46-13 and 89-15-26. The reference coordinates for the Channel 267A allotment at Linden, Tennessee, are 35-37-47 and 87-45-09. The reference coordinates for the Channel 278A allotment at New Hope, Alabama, are 34-34-50 and 86-25-17. The reference coordinates for the Channel 279C3 allotment at Walden, Tennessee, are 35-14-32 and 85-22-17. The reference coordinates for the Channel 279C1 allotment at Trussville, Alabama, are 33-26-38 and 86-52-47.