The Department of Defense (DOD) requests that the Office of Personnel Management (OPM) abolish the present Alameda-Contra Costa, CA, nonappropriated fund (NAF) Federal Wage System (FWS) wage area and establish a new Santa Clara, CA, NAF wage area. This change is necessary because the closure of the Army and Air Force Exchange Service Distribution Center in Oakland will leave the Alameda-Contra Costa wage area without a host activity to conduct a local wage survey. The Santa Clara NAF wage area will consist of Santa Clara County as the survey area. The area of application for the Santa Clara, CA, wage area will include Alameda, Contra Costa, and San Mateo Counties. A full-scale survey for the Santa Clara wage area will be conducted in September 2002.

The Alameda-Contra Costa NAF wage area is presently composed of two survey area counties, Alameda and Contra Costa Counties, and two area of application counties, San Mateo and Santa Clara Counties. The Department of Defense recommended that Santa Clara County be redefined as the sole survey county and that Alameda, Contra Costa, and San Mateo Counties be defined as area of application counties. Santa Clara County meets the minimum regulatory requirements to be an NAF survey area. There are about 90 FWS NAF employees working in Santa Clara County, and Moffett Federal Airfield has the capability to conduct a local wage survey. Santa Clara also meets the regulatory requirement of having a minimum of 1,800 private enterprise employees in establishments within the survey specifications. Since Alameda, Contra Costa, and San Mateo Counties will have continuing NAF employment and do not meet the regulatory criteria under 5 CFR 532.219 to be separate survey areas, they must be areas of application. In defining counties as area of application counties, OPM considers the proximity of the largest activity in each county to the survey area; transportation facilities and commuting patterns; and similarities in overall population, private employment in the major industry categories, and the kinds and sizes of private industrial establishments.

The Federal Prevailing Rate Advisory Committee, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, recommended by consensus the abolishment of the present Alameda-Contra Costa wage area and the establishment of a new Santa Clara wage area.

Pursuant to section 553(b)(3)(B) of title 5, United States Code, I find that good cause exists for waiving the general notice of proposed rulemaking. The notice is being waived because it is necessary to abolish the present Alameda-Contra Costa wage area and establish the new Santa Clara wage area as soon as possible to allow DOD time to prepare for the Santa Clara full-scale survey that will be conducted in September 2002.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it will affect only Federal agencies and employees.

The Supplemental Standards of Ethical Conduct for Employees of the Department of Treasury, at 5 CFR 3101.108, set forth rules that apply to employees of the Office of the Comptroller of the Currency (OCC). This final rule amends § 3101.108(b), which prohibits OCC employees from borrowing, including borrowing through the use of a credit card, from a national bank except under very limited circumstances.

Under 18 U.S.C. 213, a bank examiner is prohibited from accepting loans from a bank that he or she examines; 18 U.S.C. 212 correspondingly prohibits a bank from making a loan to someone who examines or has authority to examine the bank. 1 Current Supplemental Regulations implementing section 213 and expanding upon it generally prohibit examiners and the other “covered” OCC employees from seeking or obtaining any loan or other extension of credit from a national bank, including through the use of a credit card. 5 CFR 3101.108(b).

The existing Supplemental Regulations do contain an exception to this prohibition. A covered OCC employee  2 generally is permitted to obtain a credit card from a national bank if: (1) The credit card is obtained on terms and conditions no more favorable than those offered to the general public; (2) the employee is not assigned to examine the bank offering the credit card at the time the credit card is obtained; and (3) the employee recuses himself or herself from examining or otherwise participating in the supervision of the bank. Two issues concerning the scope of the exception have arisen since the issuance of the current rules in 1995. See 60 FR 22249-22255.

The first issue under the current credit card rules is that employees' credit card-related recusals have limited the flexibility of OCC supervisors to make assignments. The exception to the general prohibition on obtaining credit generally permits covered OCC employees to hold and use national bank credit cards if they recuse themselves from any work involving those banks. See 5 CFR 3101.108(b)(4), as adopted in 1995. In instances where covered OCC employees holding national bank credit cards are involved in OCC licensing, policy and legal staff matters directly involving the bank issuer, the OCC has found that there is little likelihood of a conflict of interest or a loss of impartiality and that the breadth of the restriction unnecessarily hinders the administration of the OCC's programs. Therefore, this final rule refines the application of the credit card rules to covered OCC employees and more closely follows the statutory prohibition.

The second issue is that the current credit card rules have significantly limited the credit card options available to employees who work in district offices and on large bank supervision teams. Under the Supplemental Regulations and the OCC ethics policies (which set forth the procedures that implement the OCC's portion of the Supplemental Regulations), covered district employees may not obtain credit cards from banks headquartered in their district. In addition, large bank team (formerly known as the “Multinational Division”) employees  3 may not have credit cards from banks supervised by their large bank team or from banks in the district where they are located. See 5 CFR 3101.108(b)(4)(i), as adopted in 1995; see also OCC Ethics Policy at 14.

The Department originally adopted the Supplemental Regulations' credit card restrictions on covered OCC district and large bank team employees, in part, to permit the supervisors of those employees to make work assignments free from the constraints that would have otherwise arisen from employees' credit card recusals. At the time they were adopted by the Department, these restrictions did not present a serious obstacle to covered district and large bank team employees obtaining credit cards. Since the issuance of the Supplemental Regulations, industry consolidation and conversions to the national bank charter have reduced sharply the credit card options available to those employees.

The Department has found that the imposition of such broad restrictions on obtaining credit cards on covered district and large bank team employees is not necessary for the administration of the OCC's supervisory activities. In situations where these covered employees are unlikely to examine a bank, the Department believes that the process of obtaining and holding a national bank credit card does not inherently present a conflict of interest or a likelihood of a loss of impartiality.

There are several changes made by these final rule amendments to address these concerns. The final rule changes the general statement of the prohibition on borrowing at 5 CFR 3101.108(b)(1) to omit the reference to credit cards as unnecessary and redundant. The import of the original provision would not be altered by this change.

The final rule also changes the Supplemental Regulations to eliminate the requirement for non-examiners (attorneys, economists, Senior Advisors, etc.) to be recused from matters involving banks from which they hold credit cards. The final rule, at § 3101.108(b)(4)(i), therefore, provides a general exception permitting non-examiners to seek or obtain credit cards from national banks on terms and conditions no more favorable than those offered to the general public. The final rule further changes the Supplemental Regulations to limit credit card recusals to examiners and to require examiners holding national bank credit cards to be recused only from bank examinations involving the issuing credit card banks, and not limit their participation in other matters, such as licensing or supervisory policy decisions affecting the bank. The exception in § 3101.108(b)(4)(ii) of the final rule, permitting examiners and their spouses and minor children to hold credit cards from banks the examiner is not assigned to examine, applies only to examiners and their spouses and minor children, and not any other covered OCC employees. The exception is available with respect to a credit card from a bank an examiner is not assigned to examine provided the credit card is obtained on terms and conditions no more favorable than those offered to the general public and the examiner maintains a written recusal from examinations of the bank.

An examiner is “assigned to examine” a bank if the examiner works either: (A) in a district, and the bank is one that he or she examines or that is assigned to his or her Assistant Deputy Comptroller (ADC) or rating official; or (B) in Large Bank Supervision, and the bank is one to which the examiner is assigned or otherwise actually examines. The term “Large Bank Supervision” in the final rule replaces the term “Multinational Division” which is used in the current regulations. This is a technical change to reflect recent changes to the OCC's management structure.

The changes to the Supplemental Regulations narrow the current prohibition on district and large bank team employees by prohibiting only examiners in districts and large banks from holding credit cards issued by banks they are assigned to examine. Because this final rule more clearly connects the credit card restriction to the examiners' actual or likely work assignments, it will provide covered OCC district and large bank team examiners greater access to credit cards without unduly restricting supervisors' flexibility in making assignments or increasing the potential for conflicts of interest.

The final rule eliminates the retail store exception in 5 CFR 3101.108(b)(4)(ii) as heretofore codified to create a uniform OCC credit card policy. With the adoption of this final rule, the need for this exception should diminish because a retail store credit card would be treated as any other national bank credit card—generally permissible for examiners who recuse themselves unless the card is issued by a national bank assigned to the examiners' ADC or by a bank they examine. The final rule also eliminates the exception for mortgage assumptions as codified until now in 5 CFR 3101.108(b)(4)(iii) because this exception arises infrequently and will be better handled by the OCC ethics staff by way of recusal or waiver pursuant to 5 CFR 3101.108(g).

Under 5 U.S.C. 553(a)(2), rules relating to agency management or personnel are exempt from the proposed rulemaking requirements of the Administrative Procedure Act (APA). As set forth in the description of the final rule, this rule affects only the OCC and its personnel. Even if this rulemaking were subject to APA proposed rulemaking procedures, the Department finds good cause, pursuant to 5 U.S.C. 553 (b) and (d), to waive the requirements for notice and comment and 30-day delayed effective date because the rule affects only the OCC and its employees (and their immediate families) and operates to relieve a restriction that has resulted in administrative and personnel inefficiencies.

Because no notice of proposed rulemaking is required for this rule, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. However, this final rule will not have a significant economic impact on a substantial number of small entities in accord with the spirit and purposes of the Regulatory Flexibility Act. This rule affects the administrative operations of the OCC and it affects OCC employees. Any effect on national banks is merely incidental and creates no cost or burden for a bank.

This final rule does not constitute a “significant regulatory action” for the purposes of Executive Order 12866.

The comma that appears at the end of paragraph (d)(1) of 12 CFR 25.62 should be a semicolon, and paragraph (d)(2) of § 25.62 should begin on a new line. Therefore, in the final rule FR Doc. 02-14130, published on June 6, 2002 (67 FR 38844), make the following correction:

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the approval design and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.

Interested persons are invited to submit such written data, views, or arguments as they may desire. Communications should identify the regulatory docket or notice number and be submitted in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE186.” The postcard will be date stamped and returned to the commenter.

On November 13, 2001, S-TEC Corporation, One S-TEC Way, Mineral Wells Airport, Mineral Wells, Texas 76067, made an application to the FAA for a new Supplemental Type Certificate for the New Piper Aircraft Corporation PA 34-200T Seneca V airplanes. The Seneca V is currently approved under Type Certificate No. A7SO. The proposed modification incorporates a novel or unusual design feature, such as digital avionics consisting of an EFIS, that is vulnerable to HIRF external to the airplane.

Under the provisions of 14 CFR part 21, § 21.101, S-TEC must show that the New Piper Aircraft Company PA 34-200T Seneca V aircraft meets the following provisions, or the applicable regulations in effect on the date of application for the change to the PA 34-200T Seneca V: The Certification Basis that is incorporated by reference for airplane model PA 34-200T Seneca V of the Type Certificate Data Sheet No. A7SO: FAR 23 August 1, 1967, through Amendment 23-6, FAR 23.1301, 1309, 1311, and 1321 as amended by Amendment 23-49, and the special conditions adopted by this rulemaking action.

If the Administrator finds that the applicable airworthiness standards do not contain adequate or appropriate safety standards because of novel or unusual design features of an airplane, special conditions are prescribed under the provisions of § 21.16.

Special conditions, as appropriate, as defined in § 11.19, are issued in accordance with § 11.38 after public notice and become part of the type certification basis in accordance with § 21.101 (b)(2).

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model already included on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.

S-TEC plans to incorporate certain novel and unusual design features into an airplane for which the airworthiness standards do not contain adequate or appropriate safety standards for protection from the effects of HIRF. These features include EFIS, which are susceptible to the HIRF environment, that were not envisaged by the existing regulations for this type of airplane.

Recent advances in technology have given rise to the application in aircraft designs of advanced electrical and electronic systems that perform functions required for continued safe flight and landing. Due to the use of sensitive solid state advanced components in analog and digital electronics circuits, these advanced systems are readily responsive to the transient effects of induced electrical current and voltage caused by the HIRF. The HIRF can degrade electronic systems performance by damaging components or upsetting system functions.

Furthermore, the HIRF environment has undergone a transformation that was not foreseen when the current requirements were developed. Higher energy levels are radiated from transmitters that are used for radar, radio, and television. Also, the number of transmitters has increased significantly. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling to cockpit-installed equipment through the cockpit window apertures is undefined.

The combined effect of the technological advances in airplane design and the changing environment has resulted in an increased level of vulnerability of electrical and electronic systems required for the continued safe flight and landing of the airplane. Effective measures against the effects of exposure to HIRF must be provided by the design and installation of these systems. The accepted maximum energy levels in which civilian airplane system installations must be capable of operating safely are based on surveys and analysis of existing radio frequency emitters. These special conditions require that the airplane be evaluated under these energy levels for the protection of the electronic system and its associated wiring harness. These external threat levels, which are lower than previous required values, are believed to represent the worst case to which an airplane would be exposed in the operating environment.

These special conditions require qualification of systems that perform critical functions, as installed in aircraft, to the defined HIRF environment in paragraph 1 or, as an option to a fixed value using laboratory tests, in paragraph 2, as follows:

(1) The applicant may demonstrate that the operation and operational capability of the installed electrical and electronic systems that perform critical functions are not adversely affected when the aircraft is exposed to the HIRF environment defined below:

(2) The applicant may demonstrate by a system test and analysis that the electrical and electronic systems that perform critical functions can withstand a minimum threat of 100 volts per meter, electrical field strength, from 10 kHz to 18 GHz. When using this test to show compliance with the HIRF requirements, no credit is given for signal attenuation due to installation.

A preliminary hazard analysis must be performed by the applicant, for approval by the FAA, to identify either electrical or electronic systems that perform critical functions. The term “critical” means those functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane. The systems identified by the hazard analysis that perform critical functions are candidates for the application of HIRF requirements. A system may perform both critical and non-critical functions. Primary electronic flight display systems, and their associated components, perform critical functions such as attitude, altitude, and airspeed indication. The HIRF requirements apply only to critical functions.

Compliance with HIRF requirements may be demonstrated by tests, analysis, models, similarity with existing systems, or any combination of these. Service experience alone is not acceptable since normal flight operations may not include an exposure to the HIRF environment. Reliance on a system with similar design features for redundancy as a means of protection against the effects of external HIRF is generally insufficient since all elements of a redundant system are likely to be exposed to the fields concurrently.

As discussed above, these special conditions are applicable to New Piper Aircraft Corporation PA 34-200T Seneca V airplane. Should S-TEC Corporation, apply at a later date for a supplemental type certificate to modify any other model on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 99-03-08, amendment 39-11022 (64 FR 5590, February 4, 1999), which is applicable to certain Boeing Model 737-600, -700, and -800 series airplanes, was published in the Federal Register on April 4, 2002 (67 FR 16064). That action proposed to continue to require repetitive inspections to detect discrepancies of the quick-disconnect coupling on the fuel hose located at the fan case firewall; corrective action, if necessary; and installation of a clamp shell on the coupling to prevent separation of the coupling halves. That action also proposed to limit the applicability of the existing requirements, clarify certain existing requirements, and require removal of the clamp shell installed previously and replacement of the existing quick-disconnect fuel supply hose, coupling, and strut fitting with new, fixed-B-nut-type parts. Such replacement would end the requirement for repetitive inspections.

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

For clarification, the FAA has revised the definition of a “general visual inspection” in this final rule.

The FAA has determined that air safety and the public interest require the adoption of the rule with the change previously described. The FAA has determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 560 airplanes of the affected design in the worldwide fleet. The FAA estimates that 271 airplanes of U.S. registry will be affected by this AD.

The inspection that is currently required by AD 99-03-08 takes approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required inspection on U.S. operators is estimated to be $16,260, or $60 per airplane, per inspection cycle.

For airplanes on which it has not already been accomplished during production, the installation of a clamp shell required by AD 99-03-08 takes approximately 2 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts are provided by the manufacturer at no cost to the operators. Based on these figures, the cost impact of the currently required installation is estimated to be $120 per airplane.

The new replacement that is required in this AD action will take approximately 4 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts will be provided by the manufacturer at no cost to the operators. Based on these figures, the cost impact of the replacement on U.S. operators is estimated to be $65,040, or $240 per airplane.

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

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

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

On May 3, 2002, a document proposing to amend Part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class E airspace extending upward from 700 feet above the surface within a 6.2-mile radius of the Lee Airport, Annapolis, MD was published in the Federal Register (67 FR 22366-22367). Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA on or before June 3, 2002. No comments to the proposal were received. The rule is adopted as proposed.

The coordinates for this airspace docket are based on North American Datum 83. Class E airspace area designations for airspace extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9J, dated August 31, 2001, and effective September 16, 2001, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published in the Order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR Part 71) provides controlled Class E airspace extending upward from 700 feet above the surface for aircraft conducting IFR operations within a 6.2 mile radius of Lee Airport, Annapolis, MD.

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

On April 16, 2002 a document proposing to amend Part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class E airspace extending upward from 700 feet Above Ground Level (AGL) for an RNAV, SIAP to the Aberdeen Field Airport, Smithfield, VA was published in the Federal Register (67 FR 18517-18518).

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA on or before May 16, 2002. No comments to the proposal were received. The rule is adopted as proposed. The coordinates for this airspace docket are based on North American Datum 83.

Class E airspace areas designations for airspace extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9J, dated August 31, 2001 and effective September 16, 2001, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be amended in the order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR Part 71) provides controlled Class E airspace extending upward from 700 feet above the surface for aircraft conducting Instrument Flight Rules (IFR) operations at the Aberdeen Field Airport, Smithfield, VA.

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

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 create 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 SIPs 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 inolvoles 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 Procrdures (44 FR 11034; February 26, 1979); and (3) does not warrant preparatioun of a regulatory evluation 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 entitis 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:

In a notice published in the Federal Register of May 12, 1998 (63 FR 26193), FDA announced that a food additive petition (animal use) (FAP 2238) had been filed by Alltech Biotechnology Center, 3031 Catnip Hill Pike, Nicholasville, KY 40356. The petition proposed to amend the food additive regulations in § 573.920 Selenium (21 CFR 573.920) to provide for the safe use of selenium yeast as a source of selenium in animal feeds for poultry, swine, and cattle. Based on the information in the petition, the selenium food additive regulation was amended to include the use of selenium yeast in feed for chickens on June 6, 2000 (65 FR 35823). FDA sought additional data from the sponsor before approving use in other species. After this data was submitted, subsequent amendments to the petition provided information to extend its use in turkeys and swine.

FDA concludes that the data establish the safety and utility of selenium yeast, for use as proposed and that the food additive regulations should be amended as set forth in this document.

In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Veterinary Medicine by appointment with the information contact person. As provided in § 571.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The agency has determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (see ADDRESSES ) written objections by September 16, 2002. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of September 22, 2000 (65 FR 57301), FDA published a proposed rule to create a separate classification for the apnea monitor. FDA proposed that the apnea monitor remain in class II, but be subject to a special control. The proposed special control was an FDA guidance document that identified minimum performance, testing, and labeling recommendations for the device.

In the same edition of the Federal Register , FDA withdrew its proposed mandatory standard for infant apnea monitors (65 FR 57303) and announced the availability of the draft guidance that FDA intended to serve as the special control for the device (65 FR 57355).

FDA invited interested persons to comment on the proposed rule by December 21, 2000. FDA received no comments. Based on a review of the available information, referenced in the preamble to the proposed rule and placed on file in FDA's Dockets Management Branch, FDA concludes that special controls, in conjunction with general controls, provide reasonable assurance of the safety and effectiveness of this device. FDA has made some revisions to the identification paragraphs in §§ 868.2375 and 868.2377 for clarity. Otherwise, FDA is finalizing the rule as proposed. Elsewhere in this issue of the Federal Register , FDA is announcing the availability of the special control guidance.

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impact of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a “new” apnea monitor will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. In the past 10 years, the agency estimates that it has received, on average, approximately four 510(k) submissions per year for breathing frequency monitor devices. FDA estimates that only one or two of these submissions per year pertained to apnea monitor devices.

Based on its review of these 510(k) submissions, FDA believes that presently marketed apnea monitors conform to the guidance and, therefore, the manufacturers of these devices will not have to take further action because of this rule. New manufacturers of apnea monitors will only need to submit 510(k)s, as the statute now requires them to do, and demonstrate that they meet the recommendations of the guidance or in some other way provide equivalent assurances of safety and effectiveness. Therefore, the agency certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In addition, this reclassification action will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore a summary statement of analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

FDA concludes that this final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et. seq. ), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA) (Public Law 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

The 1976 amendments broadened the definition of “device” in section 201(h) of the act (21 U.S.C. 321(h)) to include certain articles that were once regulated as drugs. Under the 1976 amendments, Congress classified all transitional devices, i.e., those devices previously regulated as new drugs, including the PMMA bone cement, into class III. The legislative history of the SMDA reflects congressional concern that many transitional devices were being overregulated in class III (H. Rept. 808, 101st Cong., 2d sess. 26-27 (1990); S. Rept. 513, 101st Cong., 2d sess. 27 (1990)). Congress amended section 520(l) of the act (21 U.S.C. 360j(l)) to direct FDA to collect certain safety and effectiveness information from the manufacturers of transitional devices still remaining in class III to determine whether the devices should be reclassified into class II (special controls) or class I (general controls). Accordingly, in the Federal Register of November 14, 1991 (56 FR 57960), FDA issued an order under section 520(l)(5)(A) of the act, requiring manufacturers of transitional devices, including the PMMA bone cement (21 CFR 888.3027), to submit to FDA a summary of, and a citation to, any information known or otherwise available to them respecting the devices, including adverse safety or effectiveness information which had not been submitted under section 519 of the act (21 U.S.C. 360i). Manufacturers were to submit the summaries and citations to FDA by January 13, 1992. However, because of misunderstandings and uncertainties regarding the information required by the order, and whether the order applied to certain manufacturers' devices, many transitional class III device manufacturers failed to comply with the reporting requirement by January 13, 1992. Consequently, in the Federal Register of March 10, 1992 (57 FR 8462), FDA extended the reporting period to March 31, 1992.

Section 520(l)(5)(B) of the act provides that, after the issuance of an order requiring manufacturers to submit a summary of, and citation to, any information known or otherwise available respecting the devices, but before December 1, 1992, FDA was to publish regulations either leaving transitional class III devices in class III or reclassifying them into class I or II. Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations until December 1, 1993. Due to limited resources, FDA was unable to publish the regulations before the December 1, 1993, deadline.

On January 21, 1998, FDA filed the reclassification petition submitted by OSMA, requesting reclassification of the PMMA bone cement from class III to class II. FDA consulted with the Orthopedic and Rehabilitation Devices Panel (the Panel) regarding reclassification of the PMMA bone cement. During an open public meeting on April 28, 1998, the Panel unanimously recommended that FDA reclassify the PMMA bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone from class III to class II. The Panel also recommended that FDA guidance documents, consensus standards, and labeling be the special controls to reasonably assure the safety and effectiveness of the device.

FDA considered the Panel's recommendation and tentatively agreed that the generic type of device, the PMMA bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone, be reclassified from class III into class II. FDA agreed that guidance documents, consensus standards, and labeling are appropriate special controls for the device.

After reviewing the data in the petition and presented before the Panel, and after considering the Panel's recommendation and the comments, FDA, based on the information set forth, issued an order to the petitioner on October 14, 1999, reclassifying the PMMA bone cement, and substantially equivalent devices of this generic type, from class III to class II with the implementation of special controls.

The special controls listed in the order to the petitioner were the following FDA guidance documents, consensus standards, and labeling:

1. “Use of International Organization for Standardization (ISO) 10993, `Biological Evaluation of Medical Devices Part I: Evaluation and Testing',”

2. “510(k) Sterility Review Guidance and Revision of 11/18/94 K90-1,”

3. “Guidance Document for Testing Orthopedic Bone Cement,” and

4. “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices.”

1. American Society for Testing and Material (ASTM) F 451-95 “Standard Specifications for Acrylic Bone Cement,”

2. ASTM D 638-91 “Standard Test Method for Tensile Properties of Plastics,”

3. ASTM D 732-93 “Standard Test Method for Shear Strength of Plastics by Punch Tool,”

4. ASTM D 790-98 “Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials,”

5. ASTM D 2990-95 “Standard Tensile, Compressive, and Flexural Creep and Creep Rupture of Plastics,”

6. ASTM E 399-90 “Standard Test Method for Plane-Strain Fracture Toughness of Metallic Materials,”

7. ASTM E 647-95a “Standard Test Method for Measurement of Fatigue Crack Growth Rates,” and

8. International Organization for Standardization (ISO) 5833:1992 “Implants for surgery—Acrylic resin cements.”

Do not use PMMA bone cement in the presence of active or incompletely treated infection that could involve the site where the device will be implanted.

a. Adverse cardiovascular reactions, including hypotension, hypoxaemia, cardiac arrhythmia, bronchspasm, cardiac arrest, myocardical infarction, pulmonary embolism, cerebrovascular accident, and possible death: Hypotensive reactions can occur between 10 and 165 seconds after application of the PMMA bone cement and can last for 30 seconds to 5 or more minutes. Some hypotensive reactions have progressed to cardiac arrest. The blood pressure of patients should be monitored carefully during and immediately following the application of the PMMA bone cement. In addition, overpressurization of the PMMA bone cement should be avoided during insertion of the PMMA bone cement and implant in order to minimize the occurrence of pulmonary embolism.

b. Surgeon training and experience: The surgeon should be thoroughly familiar with the properties, handling characteristics and application of the PMMA bone cement. Because the handling and curing characteristics of this cement vary with temperature and mixing technique, they are best determined by the surgeon's actual experience.

c. Device volatility and flammability and electrocautery devices: The operating room should be adequately ventilated to eliminate monomer vapors. Ignition of monomer vapors caused by the use of electrocautery devices in surgical sites near freshly implanted bone cement has been reported.

d. Irritation of the respiratory tract, eyes, and the liver: Caution should be exercised during the mixing of the liquid and powder components of the PMMA bone cement to prevent excessive exposure to the concentrated vapors of liquid monomer, which may produce irritation of the respiratory tract, eyes, and possibly the liver. Personnel wearing contact lenses should not mix PMMA bone cement or be near the mixing of the PMMA bone cement.

a. Contact dermatitis: The liquid monomer has caused contact dermatitis in those handling and mixing PMMA bone cement. Strict adherence to the instructions for mixing the powder and liquid components may reduce the incidence of contact dermatitis.

b. Hypersensitivity reactions: The liquid component of PMMA bone cement is a powerful lipid solvent. It should not contact rubber or latex gloves. Double gloving and strict adherence to the mixing instructions may diminish the possibility of hypersensitivity reactions. The mixed PMMA bone cement should not contact the gloved hand until the cement has acquired the consistency of dough, about 1 to 2 minutes after mixing.

c. Inadequate postoperative fixation: Inadequate fixation or unanticipated postoperative events may affect the PMMA bone cement-bone interface and lead to micromotion of cement against the bone surface. A fibrous tissue layer may develop between the PMMA bone cement and the bone that may cause loosening of the prosthesis. Thus, continued, periodic followup is advised for all patients.

d. Exothermic reaction: Polymerization of the PMMA bone cement is an exothermic reaction that occurs while the PMMA bone cement is hardening in situ . The released heat may damage bone or other tissue adjacent to the implant.

e. Extrusion: Extrusion of the PMMA bone cement beyond the region of its intended application may occur resulting in the following complications: Hematuria, dysuria, bladder fistula, delayed sciatic nerve entrapment from extrusion of the bone cement beyond the region of its intended application, local neuropathy, local vascular erosion and occlusion, and intestinal obstruction because of adhesions and stricture of the ileum from the heat released during the exothermic polymerization.

f. Use in pregnant women and children: The safety and effectiveness of the PMMA bone cement in pregnant women and in children is not established.

g. Expiration dating: PMMA bone cement should not be used after the expiration date because the effectiveness of the device may be compromised.

h. Disposal: Because of the volatility and flammability of the liquid monomer of the PMMA bone cement, the liquid monomer should be evaporated in a well-ventilated hood or absorbed by an inert material and transferred into a suitable container (one that does not react with the PMMA bone cement) for disposal.

a. Serious adverse events, some with fatal outcome, associated with the use of the PMMA bone cement include myocardial infarction, cardiac arrest, cerebrovascular accident, and pulmonary embolism.

b. The most frequent adverse reactions associated with the use of PMMA bone cement are transitory decreased blood pressure, elevated serum gamma-glutamyl-transpeptidase (GGTP) up to 10 days postoperation, thrombophlebitis, hemorrhage and hematoma, pain and/or loss of function, loosening or displacement of the prosthesis, superficial or deep wound infection, trochanteric bursitis, short-term cardiac conduction irregularities, heterotopic new bone formation, and trochanteric separation.

c. Other potential adverse events associated with the use of PMMA bone cement include allergic pyrexia, hematuria, dysuria, bladder fistula, delayed sciatic nerve entrapment from extrusion of the bone cement beyond the region of its intended application, local neuropathy, local vascular erosion and occlusion, intestinal obstruction because of adhesions and stricture of the ileum from the heat released during the exothermic polymerization.

FDA incorporated the four FDA guidance documents, eight consensus standards, and labeling into a class II special controls guidance entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement” that issued on August 2, 2001. The guidance document also referenced updated versions of six of the eight consensus standards listed as special controls in the reclassification order. FDA has further revised the guidance document to include the risk to health of polymerization setting problems and to clarify the warnings, precautions, and adverse reactions sections of the labeling. This class II special controls guidance document, is now the special control for this generic device.

Accordingly, as required by 21 CFR 860.136(b)(6) of the regulations, FDA is announcing the reclassification of the generic the PMMA bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone from class III into class II.

Persons interested in obtaining a copy of “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement” may do so using the Internet. The Center for Devices and Radiological Health (CDRH) maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the Internet. The CDRH home page may be accessed at http://www.fda.gov/cdrh. Guidance documents are also available from the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) (HFZ-220), Food and Drug Administration, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850. In order to receive the guidance document via your fax machine call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system and enter the document number (668) followed by the pound sign ( # ). Follow the remaining voice prompts to complete your request.

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4)). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of the device from class III to class II will relieve all manufacturers of the device of the cost of complying with the premarket approval requirements in section 515 of the act. Because reclassification will reduce regulatory costs with respect to this device, it will impose no significant economic impact on any small entities, and it may permit small potential competitors to enter the marketplace by lowering their costs. The agency, therefore, certifies that this rule will not have a significant economic impact on a substantial number of small entities. In addition, this rule will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore a summary statement or analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, or 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 agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The premarket notification information collections addressed in the guidance have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) under OMB control number 0910-0120. The labeling provisions addressed in the guidance have been approved by OMB under the PRA under OMB control number 0910-0485.

The final regulations that are the subject of these corrections is under section 894 of the Internal Revenue Code.

As published, the final regulations contain errors that may prove to be misleading and are in need of clarification.

On December 8, 1999, we published a Notice of Proposed Rulemaking (64 FR 68649), titled “Prospecting for Minerals Other Than Oil, Gas, and Sulphur in the Outer Continental Shelf.” We received several comments on the proposed rule. All comments received were considered in the formulation of the final rule. This final rule revises the regulations at 30 CFR part 280. There are no substantive changes from the proposed to the final rule. However, there were several areas that needed minor clarification.

Clarification of Certain Aspects of the Rule : After further analysis, we are clarifying the rule as follows:

• For consistency, we replaced “in the OCS” with “on the OCS” throughout the rule;

• The rule only applies to activities carried out in Federal waters and not to activities in State waters ( see § 280.2(a));

• The rule does not apply to gas hydrates, which are covered by regulations in 30 CFR part 251 ( see § 280.4(d));

• The definition of G&G prospecting activities in § 280.1 applies only to prelease activities and not to postlease activities. Postlease activities are covered in 30 CFR part 282 (see § 280.4(c));

• The definition of OCS in § 280.1 includes areas of the Exclusive Economic Zone, such as the State of Hawaii and United States possessions in the Caribbean and Pacific Ocean, which are islands and technically do not have an OCS (refer to § 280.13—filing locations table); and

• Research activities related to hard minerals require a notice, even though the activities may be federally funded ( see § 280.11(b)).

Comments on the Rule : We received comments on specific issues from the New York State Department of Environmental Conservation, Division of Mineral Resources; the New York State Department of Environmental Conservation, Division of Water; and the South Carolina Department of Natural Resources. In addition, at the request of the Office of the Solicitor, we have included definitions for “Geological Data and Information” and “Geophysical Data and Information.”

Comment : New York has an agreement regarding access to data on offshore oil and gas resources. The commenter suggests that MMS initiate preparation of an agreement necessary to allow New York access to data under proposed § 280.73.

Response : The requirement that allows coastal States access to data on offshore oil and gas resources appears in the OCS Lands Act. This requirement does not apply to hard minerals. The agreement mentioned under § 280.73 is discretionary. The MMS may disclose proprietary data to State officials but is not under any obligation to do so. A statement has been added to § 280.73(a) that the permittees and third parties who submitted proprietary data, information, and samples will be notified about a proposed disclosure and may provide comments.

Comment : Use of core sampling to detect the presence of heavy metals and other contaminants could potentially fall into the category of G&G scientific research activities requiring an MMS-approved permit or 30-day notice. The commenter suggests that an exemption for State agencies involved in environmental monitoring, research, or remediation be included in § 280.4.

Response : There are no plans to exempt State agencies from this section. The agencies should contact the Regional Director (RD) and describe the sampling for a determination on whether the activity could be construed as hard minerals research. The RD will also be looking for assurance that cores or other information will not be sold to any person involved in hard minerals research or exploration.

Comment : One commenter could not find text in the document that stated whether the MMS had a right to disapprove a scientific exploration activity.

Response: Disapproval of a permit request is addressed in § 280.12(b).

Comment : One commenter seeks a clarification on whether research and monitoring activities related to biological resources require a permit, if ancillary data on sediment type is collected as part of those studies.

Response : This type of activity is not related to hard minerals research or exploration and, therefore, neither a permit nor a notice is required. However, a permit would be required if the data on sediment type were sold to a person involved in hard minerals research or exploration.

Comment : One commenter asserts that it would be too cumbersome if specific coordinates must be identified up front instead of a general area of study since exact sampling areas are not known until the study is in progress.

Response : A general area of study is sufficient until a more specific area is known, at which time the RD should be notified.

According to the criteria in Executive Order 12866, this rule is not a significant regulatory action and is not subject to review by the Office of Management and Budget (OMB).

a. This rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. This is due to the small amount of activity currently being experienced in offshore prospecting as well as the smaller size of the companies involved as compared to those involved in oil, gas, and sulphur exploration. We estimate that this rule will affect only one entity per year, and that the total cost to regulated entities for complying with the modification of this rule will be approximately $300 per year. For full details, see the information under the heading “Regulatory Flexibility Act.”

b. This rule does not create inconsistencies with other agencies' actions because there are no changes in requirements. The notification process will allow the customer to know of the operations of other users in the area. In addition, current regulations are consistent with other agencies' actions.

c. This rule is an administrative change that will not affect entitlements, grants, user fees, loan programs, or their recipients. This rule has no effect on these programs or rights of the programs' recipients.

d. This rule does not raise any novel legal or policy issues. As previously stated, the intent of this rule is to establish consistency in all prelease activities for all minerals on the OCS.

The Department of the Interior certifies that this document will not have a significant economic effect on a substantial number of small entities under the RF Act (5 U.S.C. 601 et seq. ). The Small Business Administration (SBA) defines a small business as having:

• Annual revenues of $5 million or less for exploration service and field service companies; and

• Fewer than 500 employees for drilling companies and for companies that extract minerals other than oil, gas, or natural gas liquids.

Under the SBA's North American Industry Classification System code 213115, Support Activities for Nonmetallic Minerals (except fuels), MMS estimates that there is a total of 127 firms that could conduct geological and/or geophysical prospecting for nonenergy minerals. According to SBA criteria, 121 companies qualify as firms with fewer than 500 employees. MMS estimates that 25 percent (30) of these companies operate offshore.

The changes to 30 CFR part 280 should not have a significant economic effect. The rulemaking may involve small businesses or small entities if they want to perform prospecting activities or scientific research on the OCS.

In many ways, we try to offer customer service at no cost to smaller companies that are active on the OCS. These services include informing customers of environmental laws and regulations, making permit applications available on the Internet, making various offshore maps and stipulations accessible, etc.

There are no changes or effects with respect to the number of people performing the activities nor is there any change with regard to technology or operating costs. Changes in this rule make it parallel to the prelease exploration regulations covering oil, gas, and sulphur (30 CFR part 251). In applying for a permit, we will not require a prospecting plan. Information previously required for a prospecting plan will be submitted as a part of the permit itself. Operators will need to submit a notice for all scientific research not requiring a permit. The rule also breaks out, for clarification, procedures for submission, inspection, and selection of G&G data and information, as well as clarifying the responsibilities of third parties. It also requires us to reimburse permittees or third parties for reasonable costs for reproducing data and information that we request.

We expect that either one company may apply for a prospecting permit or one institution may file a notice of intent to conduct scientific research per year, based on MMS receiving six applications for a prospecting permit in the last 10 years. Previous activities in these areas indicate that most of these entities would be considered small.

The primary economic effect on small businesses is the cost associated with information collection activities. The only major change in reporting requirements would represent a small increase, not for those engaged in the mineral industry but, rather, for those involved in scientific research. This increased reporting requirement relates to the filing of a notice for all scientific research activities not requiring a permit. The current regulations are silent on this issue. We estimate that the new requirements may result in filing one notice per year. Each notice would require 6 hours to prepare, at a cost of $50 per hour, for a total cost of $300 per notice.

In addition, because of the small numbers of entities expected to engage in these activities at this time, the number of small businesses that would experience a significant economic effect is not substantial. As a result, this rule will not have a significant economic effect on a substantial number of small entities.

We should note that this rule only applies to preliminary prelease prospecting activities. As long as sufficient sources for economically recoverable mineral resources exist onshore, the higher costs of offshore development will constrain industry. To develop and produce even the relatively easier minerals (sand and gravel), large investments of up to $15 to $25 million will be necessary for technology and establishing both land-based processing and marketing facilities. Currently, sand and gravel are being dredged from the OCS to support large-scale public works projects to nourish beaches. These projects are authorized and funded by Federal, State, and local governments and, to date, there have been only two or three commercial aggregate producers who have expressed an interest in future OCS development.

Locating and delineating offshore mineral resources can be expensive, depending on how much is already known about an offshore area. A prospecting program to collect seismic information and to collect a number of 20-foot cores of sediment can cost approximately $100,000 to $400,000. Compared to the magnitude of these costs, the costs associated with the requirements of this rule are relatively small. Given the high costs of mineral prospecting, we expect an applicant's time and expense to comply with information collection on a prelease prospecting permit to represent only a small fraction of the total costs of locating, assessing, and developing offshore strategic minerals.

Your comments are important. The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small business about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the enforcement actions of MMS, call toll-free (888) 734-3247. You may comment to the Small Business Administration without fear of retaliation. Disciplinary action for retaliation by an MMS employee may include suspension or termination from employment with the Department of the Interior.

This rule is not a major rule under the (5 U.S.C. 804(2)), SBREFA. This rule:

(a) Does not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies or geographic regions.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or ability of United States-based enterprises to compete with foreign-based enterprises. This is based upon the small amount of activity currently being experienced in offshore prospecting, as well as the smaller size of the companies involved as compared with those involved in oil, gas, and sulphur exploration.

We examined the proposed rule and these final regulations under section 3507(d) of the PRA. Because of the changes proposed to the current 30 CFR part280 regulations, we submitted the information collection requirements to OMB for approval as part of the proposed rulemaking process. The information collection requirements in the final regulations remain unchanged from the proposed rule and a submission to OMB is not required.

The PRA provides that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number. OMB approved the requirements to collect information in 30 CFR part 280 under OMB control number 1010-0072, current expiration date of January 31, 2003.

The title of this collection of information is “30 CFR part 280, Prospecting for Minerals other than Oil, Gas, and Sulphur on the OCS.” The frequency of response is generally “on occasion” or established in the permit approval. We estimate approximately one or two respondents each year.

We use the collection of information required by these regulations to ensure there is no environmental degradation, personal harm, damage to historical or archaeological sites, or interference with other uses; to analyze and evaluate preliminary or planned drilling activities; to monitor progress and activities on the OCS; to acquire G&G data and information; and to determine eligibility for reimbursement.

Responses are mandatory or required to obtain or retain a benefit. We protect proprietary information under the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR part 2), and under regulations at 30 CFR 280.70 and applicable sections of 30 CFR parts 250 and 252. No items of a sensitive nature are collected.

Reporting and Recordkeeping “Hour” Burden: The approved annual burden of this collection of information is 88 hours.

Reporting and Recordkeeping “Non-Hour Cost” Burden: There are no “non-hour cost” burdens in the final regulations.

According to Executive Order 13132, the rule does not have significant Federalism implications. This rule does not substantially and directly affect the relationship between the Federal and State governments. The proposed rule does not change, in any way, the role or responsibilities between the Federal, State, and local governmental entities. The rule does not relate to the structure and role of the States and will not have a direct, substantive, or significant effect on States. The rule does not impose costs on States or localities. The proposed rule will not materially alter the budgetary impact of entitlements, grants, user fees, loan programs or raise legal or policy issues.

According to Executive Order 12630, the rule does not have significant Takings implications. A Takings Implication Assessment is not required because the rule would not take away or restrict an operator's right to collect data and information under the permit terms.

This rule is not a significant rule and is not subject to review by the Office of Management and Budget under Executive Order 12866. The rule does not have a significant effect on energy supply, distribution, or use because it is a modification of an already existing rule and the major modification has to do with notification of scientific research activities not exploration or energy.

According to Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of §§ 3(a) and 3(b)(2) of the Order.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment.

This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the UMRA (2 U.S.C. 1531 et seq. ) is not required.

On June 19, 2001 we published a notice of proposed rulemaking (NPRM) in the Federal Register entitled “Regulated Navigation Area; Savannah River, Georgia” (66 FR 32915). The Coast Guard received twenty-two letters commenting on the proposed rule. No public hearing was requested, and none was held.

Since immediate action was necessary to protect the public from the dangers associated with transporting LNG, on October 10, 2001 and May 10, 2002, we published two temporary final rules in the Federal Register entitled “Regulated Navigation Area: Savannah River, Georgia” (66 FR 51562 and 67 FR 31730, respectively) creating temporary rules while we published a Supplemental Notice of Proposed Rulemaking (SNPRM), received comments and prepared the final rule.

Due in part to the comments we received and changes to the initial NPRM, on December 14, 2001, we published a SNPRM in the Federal Register entitled “Regulated Navigation Area; Savannah River, Georgia” (66 FR 64778), offering the public the opportunity to comment on our revised proposal. The Coast Guard received three letters commenting on the supplemental proposed rule. No public hearing was requested, and none was held.

The Savannah River has a narrow and restricted channel with many bends. The Liquefied Natural Gas (LNG) facility is located at one of these bends on Elba Island. The LNG tankship berth is located adjacent to and parallel with the toe of the shipping channel. Because of these factors, the hazardous nature of LNG and the substantial volume of deep draft vessel traffic in Savannah (approximately 5000 annual transits), the risk of collision or allision involving an LNG tankship must be addressed.

The Elba Island LNG facility has been struck by passing vessels twice in the past 20 years. In both instances the facility was inactive. However, damage to both the facility and vessels was extensive. The potential consequences from this type of allision would be significantly more severe with an LNG tankship moored at the Elba Island dock.

The current temporary final rule expired on June 30, 2002. This final rule is needed to prevent incidents involving LNG tankships while in transit, and while moored at the facility, and is necessary to protect the safety of life and property on the navigable waters from hazards associated with LNG activities.

The Coast Guard received twenty-two comment letters addressing the original notice of proposed rulemaking. These comments and our responses can be found in the SNPRM in the Federal Register (66 FR 64778) and the temporary final rule published on October 10, 2001 (66 FR 51562). The Coast Guard incorporated some of the comments and made content changes and other administrative and numbering corrections in the SNPRM published on December 14, 2001.

We received a total of three comment letters to the SNPRM published on December 14, 2001, that restated the same concerns addressed in the NPRM. The Coast Guard stands by its previous position and comments and has not modified this final rule. In addition to the comments restated, two of these comment letters requested that the Coast Guard extend the temporary final rule for one year “to document the cost of delays and make a reasonable determination of the impact of these proposed regulations.” As stated in the comments section of the SNPRM and the regulatory evaluation section of this final rule, the Coast Guard maintains our position that the costs associated with this rule will be minimal and we do not agree that an extension of the temporary rule is necessary. If however, as experience with this rule is gained and costs are documented which warrant a reassessment of this rule, the Coast Guard may review the cost and benefits of the final rule and may revise it.

A third comment letter received in response to the SNPRM suggested that the “Captain of the Port be given the authority to waive portions of the final rule which operational experience has shown to be unnecessary.” The final rule allows the Captain of the Port to waive any requirements imposed by this rule, if the Captain of the Port finds that it is in the best interest of safety or in the interest of national security.

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

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. Only an estimated one percent of the annual transits on the Savannah River will be LNG tankships. Further, all LNG transits will be coordinated and scheduled with the pilots and the Coast Guard Captain of the Port to minimize port disruption and delays for other commercial traffic and the LNG tankships themselves. Finally, requests to enter the Regulated Navigation Area (RNA) may be granted on a case-by-case basis by the Coast Guard Captain of the Port.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because LNG vessels will comprise an estimated one percent of the large commercial vessel transits on the Savannah River. Further, the tug escort requirements of this rule for vessels transiting past a moored LNG vessel will only affect an estimated 12 percent of all large commercial vessel transits on the River and are provided by the LNG facility. Delays, if any, will be minimal because vessel speeds would be reduced regardless of tug requirements. Delays for inbound and outbound traffic due to LNG transits will be minimized through pre-transit conferences with the pilots and the Coast Guard Captain of the Port. Finally, the RNA requirements are less burdensome for smaller vessels, which are more likely to be small entities, because of the lower risk associated with these vessels.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pubic Law 104-121), we offered to assist small entities in understanding this rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT . Small businesses may also send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Although this rule would not result in such expenditure, we do discuss the effects of this rule elsewhere in the preamble.

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.

VA is amending its adjudication and fiduciary regulations to reflect the reorganization of the Adjudication and Veterans Services Divisions into Veterans Service Centers and to reflect the elimination of the positions of the Adjudication Officer and the Veterans Services Officer and the creation of the position of the Veterans Service Center Manager. Other nonsubstantive changes are made for clarity.

This final rule consists of nonsubstantive changes and, therefore, is not subject to the notice and comment and effective date provisions of 5 U.S.C. 553.

The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more in any given year. This final rule would have no consequential effect on State, local, or tribal governments.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. This rule merely consists of nonsubstantive changes. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance program numbers are 64.104 and 64.109.

The Board of Veterans' Appeals (Board) is an administrative body that decides appeals from denial of claims for veterans' benefits. Among other remedies, appellants may challenge final Board decisions on the grounds that they were the product of clear and unmistakable error (CUE). 38 U.S.C. 7111; 38 CFR 20.1400-20.1411.

On July 10, 2001, VA published in the Federal Register at 66 FR 35902 an interim final rule relating to CUE motions. Essentially, that rule modified 38 CFR 20.1404 to provide that, where the motion does not meet the pleading requirements set forth in VA rules, the motion will be dismissed without prejudice to refiling.

We provided a 60-day comment period that ended on September 10, 2000. We received no comments. Based on the rationale set forth in the interim final rule, we adopt those changes as a final rule.

This document without any changes affirm amendments made by an interim final rule that is already in effect. Accordingly, we have concluded under 5 U.S.C. 553 that there is good cause for dispensing with a delayed effective date based on the conclusion that such procedure is impracticable, unnecessary, and contrary to the public interest.

The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more in any given year. This final rule would have no consequential effect on State, local, or tribal governments.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Domestic Mail Manual (DMM), incorporated by reference in title 39, Code of Federal Regulations, part 111, contains the basic standards of the U.S. Postal Service governing its domestic mail services, descriptions of the mail classes and special services and conditions governing their use, and standards for rate eligibility and mail preparation. The document is amended and republished periodically, with each issue sequentially numbered. Interim updates of the DMM are posted monthly on the USPS Postal Explorer Web site ( http://pe.usps.gov ). DMM Issue 57, the next printed edition, is dated June 30, 2002. Issue 57 contains all changes previously published in the Federal Register (including the changes to implement the R2001-1 Omnibus Rate Case, published in 67 FR 18684) and all other changes listed below. Announcements were first published in the Federal Register and/or various issues of the Postal Bulletin, an official biweekly document published by the Postal Service.

In addition, the revised table of contents of DMM Issue 57 is presented.

The following changes were adopted as part of the R2001-1 Omnibus Rate Case. These changes are effective June 30, 2002.

A010 is amended to remove references to upgradable mail and to include a preferred location for addresses on letter-size pieces.

The title of A800 is changed to show the standards apply to all automation-compatible mail, not just mail claimed at automation rates.

A950 is revised to clarify that the mailer's signature on a postage statement certifies the mail meets the requirements for the rates claimed and to change the requirements for filing Form 3553, Coding Accuracy Support System (CASS) Summary Report . Mailers are no longer required to submit Form 3553 with each mailing.

C010 is amended to show that Standard Mail Enhanced Carrier Route (ECR) letters are subject to the standards for mailpiece dimensions and to remove information about the First-Class Mail nonstandard surcharge. C050 is amended to add the nonmachinable characteristics for letters.

C100.2.7 is amended to clarify the guidelines for perforations and tearing guides on cards. C100.4.0 is revised to reflect changes to the nonmachinable surcharge (formerly the “nonstandard surcharge”) for some First-Class Mail letters and flats.

C700 is amended to note that mailpieces meeting any of the characteristics listed in C700.2.0 and that are mailed at the DSCF Parcel Select rate are subject to the nonmachinable surcharge.

C810 is amended to remove references to upgradable First-Class Mail and Standard Mail, to increase the weight limit for Standard Mail automation and ECR letters to 3.5 ounces, and to clarify that signing a postage statement certifies the mail meets the requirements for the rates claimed.

C820 is amended to add a weight limit for Bound Printed Matter flats claimed at automation rates.

C830 is deleted. C830 contained standards for upgradable mail, including address placement, OCR read area, fonts, and reflectance. The upgradable preparation for letters is replaced with a machinable preparation; the machinable preparation has no requirements for address placement, OCR read area, etc.

C840 is amended to remove references to upgradable mail.

D210.3.4 is amended to show that the destination sectional center facility (DSCF) rate will apply to eligible mail entered at the DSCF under exceptional dispatch. D210.4.0 is revised to show that the DSCF rate will not apply to mail entered at airport mail facilities (AMFs).

D230.2.2 and 4.6 are deleted to remove the standards for Periodicals contingency entries.

D500 is amended to include additional circumstances that affect postage refund requests for Express Mail when the service guarantee is not met.

E110.3.0 is amended to clarify the eligibility for pieces mailed at First-Class Mail card rates.

E120.2.2 is amended to change the Priority Mail flat rate from the 2-pound rate to the 1-pound rate. E120.2.4 reflects changes to show that keys and identification devices that weigh more than 13 ounces but not more than 1 pound are returned at the 1-pound Priority Mail rate plus the fee shown in R100.10.0. Keys and identification devices that weigh more than 1 pound but not more than 2 pounds are charged the 2-pound Priority Mail rate for zone 4 plus the fee in R100.10.0.

E130 is amended to show that the nonmachinable surcharge will apply to keys and identification devices, certain letter-size and flat-size pieces mailed at single-piece and Presorted rates, and all pieces where the mailer chooses the manual only (“do not automate”) preparation option. It also is amended to clarify that signing a postage statement certifies the mail meets the requirements for the rates claimed.

E140 is amended to reorganize the information about rate application into two separate sections: one for cards and letter-size mail (2.0) and one for flat-size mail (3.0). E140.2.0 is amended to replace the basic rate with the new AADC and mixed AADC rates. E140.3.0 is amended to replace the basic rate with the new ADC and mixed ADC rates and to clarify the definition of a piece that is subject to the nonmachinable surcharge. E140 is amended to clarify that signing a postage statement certifies the mail meets the requirements for the rates claimed.

E217.1.0 and 3.0 are amended to reflect references to the new destination area distribution center (DADC) rates and discounts for Outside-County and Outside-County Science-of-Agriculture rates. E217.5.0 is restructured for clarity and amended to include standards for the new per piece pallet and per piece destination entry pallet discounts.

The standards for combining multiple publications or editions in E220.3.0 and E230.4.0 are consolidated into new M230. E220 and E240 are amended to clarify that signing a postage statement certifies the mail meets the requirements for the rates claimed.

E250 is revised in its entirety to clarify standards for all destination entry Periodicals mailings; to include the new destination area distribution center (DADC) entry rates and discounts; and to reflect that for rate eligibility DSCF pieces must be deposited at the DSCF or a USPS-designated facility. E250.1.1 clarifies that for rate eligibility an individual package, tray, sack, or pallet may contain pieces claimed at different destination entry rates and discounts.

New E260 (former G094) describes the standards for the Periodicals Ride-Along classification and rate, which is now a permanent classification. All of G094 is moved except for 2.0 and 3.0. Former 2.0, which contains the rate information, appears in R200. Former 3.0 is deleted, as publishers are no longer required to submit additional documentation with Ride-Along mailings.

E500 is amended to change the Express Mail flat rate from the 2-pound rate to the 1/2-pound rate.

E610.8.0 is amended to remove references to upgradable Standard Mail.

E620 is amended to remove references to upgradable mail and to show that the nonmachinable surcharge may apply to letter-size pieces that weigh 3.3 ounces or less and to all pieces where the mailer chooses the manual only (“do not automate”) option. E620.1.2 is amended to remove the requirement that residual volumes must appear on the same postage statement.

E630 is reorganized for clarity. Standards are added to show that ECR letter-size pieces mailed at saturation and high density letter rates must be automation-compatible and must have a delivery point barcode. New language is added to explain the discount for automation-compatible pieces that weigh between 3.3 and 3.5 ounces.

E640 is amended to replace the basic automation letter rate with the new AADC and mixed AADC rates and to add the discount for automation letters that weigh between 3.3 and 3.5 ounces. E640.2.0 is amended to add the discount for ECR basic automation letters that weigh between 3.3 and 3.5 ounces.

E620 and E640 are amended to clarify that signing a postage statement certifies the mail meets the requirements for the rates claimed.

E712.1.1b is revised to add a weight limit for BPM flats claiming the barcoded discount. E712.1.4, which excluded BPM flats from eligibility to receive an automation rate, is removed. E712.2.0 is amended to add a new standard for BPM automation flats. E712.2.0e is added to include a barcoded discount for automation flats. E712.3.0 is amended to clarify that the mailer's signature on the postage statement certifies the mail meets the requirements for the rates claimed.

E713 and E714 are revised in their entirety to reflect the format used for BPM in E712. E713 and E714 are amended to show the new basic rate and to reduce the mailing minimum from 500 pieces to 300 pieces.

E751.1.1 is amended to add provisions to require mail on pallets for 3-digit ZIP Code prefixes to be entered at the SCF. E751.1.4 is amended to clarify that nonmachinable parcels sorted to 3-digit ZIP Code prefixes must be entered at a designated SCF. In E751.2.2 references are added to allow the preparation of 3-digit sacks and 3-digit pallets. E751.5.0 and E753 are amended to change the references from “BMC rate” to “basic rate.”

F010.4.0 is amended to remove references to nonstandard mail. F010.5.2 is amended to show that the nonmachinable surcharge can be charged on Periodicals returned at First-Class Mail single-piece rates. F010.5.3 is amended to show that the First-Class Mail single-piece nonmachinable surcharge is included in the calculation of the weighted fee for returned pieces and is charged on some returned Standard Mail pieces. F010.6.0 is amended to include these same changes.

F030.1.1 is amended to clarify the circumstances under which address notices are not provided by the Postal Service.

G091.4.0 is revised to clarify that some pieces using NetPost Mailing Online are eligible for the mixed ADC or mixed AADC rate.

The titles and summaries of labeling lists L001, L800, L802, and L803 are amended to reflect new mail preparation options.

M011.1.3 is amended to show that a full letter tray is defined as one that is between 75% and 100% full. M011.1.4 is amended to remove references to upgradable mailings, to show that machinable and nonmachinable pieces cannot be part of the same mailing, and to show that ECR letter rate pieces cannot be part of the same mailing as nonletter rate pieces. M012.2.0 is revised to update information about multiline optical character reader (MLOCR) markings. M012.3.3 is revised to include additional rate markings for BPM Presorted barcoded flats and BPM carrier route flats. M012.4.5 is deleted to remove references to upgradable mail.

M020.1.6 is amended to include Media Mail and Library Mail in the requirements for package size. In addition, the maximum weight for packages in sacks is 20 pounds unless otherwise noted, and packages of BPM automation flats must meet the preparation requirements in M820. M020.2.0 is amended to include additional standards for packaging Media Mail and Library Mail. M020.2.1 is amended to remove references to the upgradable preparation for First-Class Mail and Standard Mail and to show that nonmachinable and manual-only pieces must be packaged. M020.2.2 is amended to require that Media Mail and Library Mail pieces meet specific weight limits when placed in sacks or on pallets.

The container labeling requirements in M031.5.0 are amended to revise the Line 2 codes for “carrier routes,” “letters,” and “machinable” and to add a new Line 2 code for “manual.” M032 Exhibit 1.3a is amended to change the content identifier number (CIN) codes for the new machinable and nonmachinable preparation for First-Class Mail and Standard Mail letter-size pieces. The exhibit also is amended to add new CIN codes for Standard Mail ECR letters and designate CIN codes for certain Package Services flat-size pieces. M033.2.0 is amended to clarify standards for filling letter trays.

M041.5.0 is amended to show that the minimum volume for letter trays on pallets can be measured in linear feet or by the number of layers of trays on the pallet. M041.5.5 is amended to clarify the maximum load of a pallet. M045.3.2 is amended to add that pallets with carrier route mail must show whether the mail is barcoded, machinable, or manual. M045.3.3 through 3.5 show revised titles that include Media Mail and Library Mail. M050.4.1 is amended to show that signing a postage statement certifies the mail meets the requirements for the rates claimed.

M130 is revised to show the packaging, traying, and labeling standards for machinable, nonmachinable, and “manual only” letter-size mail.

The standards for combining multiple publications or editions in M210.6.0 and M220.6.0 are consolidated and relocated in new M230.

M610 is revised to show the packaging, traying, and labeling standards for machinable, nonmachinable, and manual only letter-size mail. M630 is revised to show the new Line 2 labeling for trays of ECR letter-size pieces.

M710.2.1 is revised to add provisions for a 3-digit sort level for nonmachinable parcels claiming DSCF rates. M730 and M740 are amended to change references from “BMC rate” to “basic rate” and to include separate preparation standards for Media Mail and Library Mail flats, irregular parcels, and machinable parcels. The option to prepare sacks based on a minimum of 1,000 cubic inches of mail is added for Media Mail and Library Mail.

M810.1.0 is amended to replace references to the automation basic rate for letter-size pieces with the new AADC and mixed AADC rates. M810.2.0 is amended to show the new Line 2 labeling format for First-Class Mail and Standard Mail carrier route automation letters.

M820.1.0 is amended to replace references to the automation basic rate for flat-size pieces with the new ADC and mixed ADC rates. M820.6.1 is revised to provide packaging and sacking standards for flat-size pieces eligible for the Bound Printed Matter automation rates.

P011.1.0 is amended to reflect that the nonstandard surcharge is replaced with the new nonmachinable surcharge.

P012.2.0 is amended to require standardized documentation for Bound Printed Matter flats entered at automation rates and to add new rate level abbreviations for the AADC, ADC, mixed AADC, and mixed ADC rates. P012.3.0 is amended to reflect references to the new DADC rate for Periodicals. P012.4.0 is amended to clarify the standards for facsimile postage statements.

P013.1.0 is amended to clarify the rate calculation and computation standards. P013.2.0 is amended to reflect the zoning of Priority Mail rates affecting all pieces over 1 pound. This section also is amended to reflect that each Express Mail or Priority Mail flat-rate envelope is charged the Express Mail 1/2 -pound rate or the Priority Mail 1-pound rate. P013.8.0 is amended to show how to calculate postage for Standard Mail automation rate letter-size pieces and ECR automation-compatible letter-size pieces that weigh more than 3.3 ounces.

P014.5.0 is amended to expand the circumstances under which the Postal Service may deny Express Mail postage refund requests when the service guarantee is not met.

P021.3.1 is amended to note the availability of stamped cards.

P100.4.0 and 5.0 are amended to change “nonstandard surcharge” to “nonmachinable surcharge.”

P200.1.5 is amended to include requirements for separating DADC entry pieces if the mailing is not presented with mailing documentation at the time of postal verification. New P200.1.8 contains the standards relocated from P200.2.4 for waiving nonadvertising rates.

P600.2.0 is amended to include standards for the new nonmachinable surcharge for Standard Mail and to add calculations for automation and ECR heavy letters.

P910 is amended to add new rate category abbreviations for the AADC, ADC, mixed AADC, and mixed ADC rates for First-Class Mail and Standard Mail.

P950 is revised in its entirety to clarify the standards that apply to plant-verified drop shipment (PVDS).

P960 is amended to clarify when MLOCR markings must appear on mailpieces and to add new markings for the AADC, ADC, mixed AADC, and mixed ADC rates for First-Class Mail and Standard Mail.

Module R is revised in its entirety to reflect the new rates and fees for all classes of mail and special services.

S010 and S500 are amended to reduce the indemnity included in the base price of Express Mail service from $500 to $100.

S020 is amended to increase the maximum amount of a single money order from $700 to $1,000.

S911 and S912 are amended to include the new service enhancement for registered mail and certified mail. This enhancement will allow mailers to obtain delivery information at www.usps.com by entering the article number shown on the mailing receipt.

S918 and S919 are amended to extend Delivery Confirmation and Signature Confirmation to First-Class Mail parcels, and also to limit this service for Package Services mail to parcels. S918 and S919 also specify that for the purposes of adding Delivery Confirmation or Signature Confirmation service, a parcel is required to meet the definition in C100.5.0 or C700.1.0.

A010.1.2, A010.3.2, and A010.5.3 are revised to reflect changes in mail delivery procedures to commercial mail receiving agencies. Effective 9-7-00.

A010.4.3 is revised to remove the requirement that a return address appear on Bound Printed Matter pieces with no ancillary service endorsement or special service. Effective 9-6-01.

A920 is revised to reflect a new option for mailing list owners to have their address lists sequenced electronically. Effective 7-1-01.

A930 is revised to fully describe mail sequencing product options. Effective 9-6-01.

C010.6.5 is revised to allow more flexibility in designing and producing reusable envelopes. Effective 5-2-02.

C010.8.3 and C050.4.2 are amended to clarify that soft goods weighing more than 5 pounds may be mailed as machinable parcels. Effective 3-8-01.

C023.11.5 is revised to amend the standards for the mailability of magnetized materials. This amendment aligns the postal standards for magnetized materials with the U.S. Department of Transportation (DOT) regulations in Title 49, Code of Federal Regulations (49 CFR). Effective 6-14-01.

C200.1.4b is revised to amend the standard for loose enclosures at Periodicals rates. The revised standard allows as permissible enclosures receipts, requests, orders for a subscription, and printed matter (which is part of or accompanied by and related exclusively to a request or order for a subscription) for any Periodicals publication (including publications pending Periodicals authorization), provided other products or services are not advertised, promoted, or offered. Effective 6-14-01.

C200.1.10 is revised to amend the standard for label carriers for Periodicals. This revision allows mailers to put information about any Periodicals publication on the label carrier. Effective 1-10-02.

C700.2.0 is amended to clarify that the nonmachinable surcharge for Parcel Post does not apply to parcels that contain perishable items. Effective 5-3-01.

C820 is revised to include standards for automation flats for the Automation Flat Sorting Machine (AFSM) 100. Effective 6-30-02.

D010.1.5 is amended and D010.1.8 is added to reflect changes made to Form 5541, Pickup Service Statement , and to include the availability of pickup service for international mail. Effective 11-1-01.

D042.2.5, D042.2.6, and D042.2.7 are revised to reflect changes in mail delivery procedures to commercial mail receiving agencies. Effective 9-7-00.

D042.2.8 is added to provide procedures to identify when an office business center is considered a commercial mail receiving agency for postal purposes. Effective 12-14-01.

D042.2.6 is revised to reflect changes in mail delivery procedures to commercial mail receiving agencies. Effective 3-8-01.

D230 is revised to allow the Postal Service to cancel a Periodicals publication's additional entry authorization when the additional entry is not used for an entire calendar year. Effective 6-14-01.

D500.2.3 is revised to include information about Express Mail Manifesting. Effective 5-2-02.

D910 is revised to clarify the application procedure for post office box service. Effective 8-23-01.

E120.1.4 is revised and Exhibit E120.1.4 is added to reflect the standard guidelines for creating package shipping labels. Effective 4-5-01.

E213.3.6 is revised to allow refunds for Periodicals mailings paid at First-Class Mail rates under certain circumstances. Effective 12-13-01.

E260.1.3 is revised to include standards for automation flats for the Automation Flat Sorting Machine (AFSM) 100. Effective 6-30-02.

E500.1.0 is updated to include information on Express Mail delivery and waiver of signature. Effective 7-1-01.

E500.1.8 and E500.1.9 are revised to include information about Express Mail Manifesting. Effective 5-2-02.

E610, E620, E713, E714, E751, E752, and E753 are revised for the new optional 5-digit scheme preparation for Standard Mail machinable and irregular parcels and for Package Services machinable and nonmachinable parcels. Effective 7-12-01.

E610 and E752 are revised to implement mail preparation changes for First-Class Mail, Standard Mail, and Bound Printed Matter flats. Effective 9-1-01.

E620.2.0 is amended to clarify that commingled Standard Mail machinable and irregular parcels are eligible for 3/5 rates. Effective 10-4-01.

E650.6.1 and E752.3.0 are revised to allow a new optional level of pallet sort for a limited number of sectional center facility (SCF) service areas. This option is available for Periodicals nonletters (flats and irregular parcels), Standard Mail flats, and Bound Printed Matter flats prepared on pallets. Effective 3-31-02.

E670.5.11 is revised to reflect an increase for low-cost products mailable at Nonprofit Standard Mail rates. Effective 1-1-01 and 1-1-02.

E670.8.1 is revised to introduce an option to mail at Nonprofit Standard Mail rates via the NetPost Mailing Online experiment. Effective 4-5-01.

E710.3.1 is revised to remove the requirement that a return address appear on Bound Printed Matter pieces with no ancillary service endorsement or special service. Effective 9-6-01.

E712.1.2 is revised to rescind provisions concerning merchandise samples as enclosures with Bound Printed Matter. In its place, E712.1.2b provides for the inclusion of “nonprint” attachments and enclosures so long as such attachments and enclosures are incidental to the qualifying Bound Printed Matter material and have minimal commercial value. Effective 6-14-01.

E751 Exhibits 6.0, 7.0, and 8.0 are amended to add, delete, and change ZIP Codes for Parcel Select destination entry. Effective 2-8-01, 2-22-01, 4-19-01, 5-28-01, 6-28-01, 7-12-01, 7-26-01, 8-23-01, 9-20-01.

Exhibit F010.4.1 is revised to reflect changes in mail delivery procedures to commercial mail receiving agencies. Effective 9-7-00.

F010.4.7 is added to clarify that undeliverable-as-addressed Mailgrams are treated as First-Class Mail. Effective 10-4-01.

G030 is amended to clarify the method used to determine postal zones and to update postal zone information. Effective 6-30-02.

G091.2.1, G091.2.2, G091.3.0, and G091.4.1 are revised to introduce an option to mail at Nonprofit Standard Mail rates via the NetPost Mailing Online experiment. Effective 4-5-01.

G095 is added to describe the eligibility, standards, physical characteristics, markings, and rates that apply to the experimental presorted Priority Mail classification. Effective 7-15-01.

Labeling lists are periodically updated to reflect changes in mail processing operations. Please see individual lists.

M011.1.0, M031.4.9, M041.5.0, M045.3.0, M920, M930, and M940 are revised to allow a new optional level of pallet sort for a limited number of sectional center facility (SCF) service areas. This option is available for Periodicals nonletters (flats and irregular parcels), Standard Mail flats, and Bound Printed Matter flats prepared on pallets. Effective 3-31-02.

M011.1.3, M011.1.4, M045.2.2, M130.1.7, M210.1.0, M220.1.0, M610.1.0, M620.1.0, M820.1.0, M910, M920, M930, and M940 are revised and M950 is added to provide a new preparation option that allows mailers to combine flat-size automation rate pieces and flat-size Presorted rate pieces of the same mail class within the same package. This new preparation option is called “co-packaging” and is available for First-Class Mail, Periodicals, and Standard Mail. Effective 3-31-02.

M011.1.3 and M013.1.1 are revised and M210.5.0 and M220.5.0 are deleted to remove the option that allows mailers to bedload bundles of Periodicals flats. Effective 3-31-02.

M011, M032, M041, M045, M073, M610, M710, M722, M723, M730, and M740 are revised for the new optional 5-digit scheme preparation for Standard Mail machinable and irregular parcels and for Package Services machinable and nonmachinable parcels. Effective 7-12-01.

M011, M041, M045, M130, M610, M620, M723, M820, M910, M920, M930, and M940 are revised to implement mail preparation changes for First-Class Mail, Standard Mail, and Bound Printed Matter flats. Effective 9-1-01.

M012 is revised to discontinue the use of old markings on Bound Printed Matter, Media Mail, and Library Mail. These markings were changed on January 7, 2001, in conjunction with the R2000-1 Omnibus Rate Case. Mailers were given until January 1, 2002, to change over to the new markings and use any preprinted stationery and packaging. Effective 1-1-02.

M012.3.1 is revised and Exhibit M012.3.1 is added to reflect the standard guidelines for creating package shipping labels. Effective 4-5-01.

M013 is revised to provide mailers with two new optional endorsement lines (OEL). These new format options allow mailers to list carrier route line-of-travel (LOT) information for Periodicals and Standard Mail within an OEL. Effective 6-14-01.

M020 is revised to improve package integrity for Periodicals and Standard Mail by prescribing basic standards for preparing and securing all packages and incorporating standards that pertain individually to packages on pallets, packages in sacks, and packages in trays. Effective 7-1-01.

M031, M045, M920, M930, and M940 are revised to require pallets of Periodicals and Standard Mail containing carrier route mail and/or Presorted rate mail to show “NONBARCODED” or “NBC” in the pallet label. These pallet label standards were originally revised effective January 7, 2001, in conjunction with implementation of the R2000-1 omnibus rate case. Mailers were given until July 15, 2001, to comply. Effective 7-15-01.

M031.3.1 is amended to clarify label holder placement on letter and flat trays. Effective 10-4-01.

M031.4.0 is amended to clarify the required information that must appear on a pallet label. This revision provides descriptions of what should appear on the destination line (Line 1), content line (Line 2), and office of mailing or mailer information line (Line 3) of pallet labels. Effective 6-14-01.

M031.4.7 is amended to correct information about the mailer information line on pallet labels. Effective 7-12-01.

M032.2.3 is revised to show that zebra codes (the series of diagonal or vertical marks on barcoded tray labels) are required only on trays of automation letters and flats. Effective 11-1-01.

M041.5.3 is revised to remove the minimum weight requirement for pallets of Periodicals, Standard Mail, and Package Services mail dropped at a destination delivery unit by the mailer or mailer's agent. Effective 6-14-01.

M050 is revised to change the documentation requirements for Periodicals and Standard Mail mailings sequenced in line-of-travel (LOT) order. Effective 9-6-01.

M500.2.2 is revised to show that the waiver of signature option is not available for Express Mail Custom Designed Service. Effective 12-27-01.

M500.2.2 and M500.3.3 are updated to include information on Express Mail delivery and waiver of signature. Effective 7-1-01.

M500.3.0 is revised to include information about Express Mail Manifesting. Effective 5-2-02.

M820.1.0 is revised to include standards for automation flats for the Automation Flat Sorting Machine (AFSM) 100. Effective 6-30-02.

P012.2.4 is revised to allow a new optional level of pallet sort for a limited number of sectional center facility (SCF) service areas. This option is available for Periodicals nonletters (flats and irregular parcels), Standard Mail flats, and Bound Printed Matter flats prepared on pallets. Effective 3-31-02.

P013.6.0, P500.1.1, and P910.4.1 are revised and P910.6.0, P910.7.0, and P910.8.0 are added to include information about Express Mail Manifesting. Effective 5-2-02.

P013.7.1, P013.7.2, and P200.1.2 are revised and P200.4.0 is added to add references to the new Periodicals Accuracy, Grading, and Evaluation (PAGE) Program. PAGE can be used to determine per-copy weights and to substantiate the advertising percentage in Periodicals. Effective 3-7-02.

P014 is revised to clarify the refund policy for metered postage. Effective 1-1-02.

P014 and P022 are revised to reflect changes in the pricing of semipostal stamps and to add a new semipostal stamp. Effective 3-7-02.

P030 is revised in its entirety to include policies and regulations pertaining to more secure postage evidencing systems, such as those digitally printing meters that use a Postal Security Device (PSD), those digitally printing meters that generate information-based indicia (IBI), and PC Postage systems. Effective 1-1-02.

P030 is revised to allow the use of information-based indicia (IBI) to show evidence of postage in the same manner as letterpress and digital meter stamps. This extends the use of IBI to all mail classes except Periodicals. Effective 7-17-01.

P030 is revised to allow zoned-rate metered Priority Mail to be deposited in collection boxes. Effective 10-4-01.

P030.8.3 is deleted because the restrictions on mixed forms of postage evidencing are no longer necessary. Effective 5-2-02.

P030.11.4 is revised to clarify the locations at which metered mail can be deposited. Effective 3-7-02.

P040.2.4 is revised to allow more flexibility in designing and producing reusable envelopes. Effective 5-2-02.

P910 is revised to reflect minor revisions to procedures for manifest mailings. Effective 1-1-02.

P920 is revised to clarify the standards for entry of mail under optional procedures. Changes include reorganization of the standards and clarification of record keeping and quality control requirements as well as procedures for applying to mail under an OP Mailing System. Effective 3-7-02.

R000 is revised to reflect changes in the pricing of semipostal stamps and to add a new semipostal stamp. Effective 3-7-02.

R200 is revised to include standards for automation flats for the Automation Flat Sorting Machine (AFSM) 100. Effective 6-30-02.

S010.2.5 and S500.1.1 are revised to include information about Express Mail Manifesting. Effective 5-2-02.

S500.1.4, S500.1.5, and S921.1.9 are revised to show that the waiver of signature option is not available for Express Mail Custom Designed Service and to update the language for the availability of COD service with Express Mail service. Effective 12-27-01.

S913.2.5 is revised to reflect the updated Publication 91, Confirmation Services Technical Guide . S919.2.1c, S919.3.3a, and Exhibit S919.2.1c are revised and Exhibit S919.3.3 is added to reflect standard guidelines for mailers designing and printing their own shipping labels. Effective 7-1-01.

S916.3.3 is revised to update authorized agent information to support the revised Form 3849, Delivery Notice/Reminder/Receipt , and the electronic record management program. Effective 7-1-01.

I022, Subject Index, is revised and reorganized with new key words and concepts. Effective 9-6-01.

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

On July 20, 2001, these rule submittals were found to meet the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.

MBUAPCD adopted a version of Rule 416 on April 20, 1994, which EPA approved into the SIP on February 12, 1996. SCAQMD adopted a version of Rule 1102 on December 7, 1990, which EPA approved into the SIP on March 24, 1992. MBUAPCD adopted revisions to Rule 416 on January 17, 2001 and SCAQMD adopted revisions to Rule 1102 on November 17, 2000. Both rules were submitted to EPA for SIP approval on May 8, 2001.

MBUAPCD Rule 416 has been revised to identify all VOCs as being ozone precursors and subject all emission units to 40 lb/day emission limit unless they are granted a higher limit based upon historical operations or upon Best Available Control Technology or New Source Review requirements.

SCAQMD Rule 1102 has been revised to achieve VOC reductions by phasing out transfer machines that use solvents containing VOC and requiring closed-loop machines instead. The amendments exempt all types of dry cleaning machines that use solvents containing Group II exempt compounds other than perchloroethylene except for certain recordkeeping and reporting requirements.

Other minor changes are made to improve clarity and enhance enforceability.

The TSDs have more information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas (see section 182(a)(2)(A)), and must not relax existing requirements (see sections 110(l) and 193). The MBUAPCD and SCAQMD regulate ozone nonattainment areas (see 40 CFR part 81), so Rules 416 and 1102 must fulfill RACT.

Guidance and policy documents that we used to help evaluate specific enforceability and RACT requirements consistently include the following:

1. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987.

2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D of November 24, 1987 Federal Register Document,” (Blue Book), notice of availability published in the May 25, 1988 Federal Register .

3. U.S. EPA Region IX—Guidance Document for Correcting Common VOC & Other Rule Deficiencies, Revised August 21, 2001, (A.K.A., “The Little Blue Book”).

We believe these rules improve the SIP and are consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by August 16, 2002, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on September 16, 2002. This will incorporate these rules into the federally enforceable SIP.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Why were these rules submitted?

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Table 2 lists some of the national milestones leading to the submittal of these local agency VOC rules.

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-2002-0112. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA published final rules in the Federal Register for each chemical/commodity listed below. The initial issuance of these final rules announced that EPA, on its own initiative, under section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) was establishing time-limited tolerances.

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

EPA received requests to extend the use of these chemicals for this year's growing season. After having reviewed these submissions, EPA concurs that emergency conditions exist. EPA assessed the potential risks presented by residues for each chemical/commodity. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18.

The data and other relevant material have been evaluated and discussed in the final rule originally published to support these uses. Based on that data and information considered, the Agency reaffirms that extension of these time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are extended until the date listed below. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on the date listed, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on the commodity after that date will not be unlawful, provided the residue is present as a result of an application or use of a pesticide at a time and in a manner that was lawful under FIFRA, the tolerance was in place at the time of the application, and the residue does not exceed the level that was authorized by the tolerance. 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.

Tolerances for the use of the following pesticide chemicals on specific commodities are being extended:

1. Bifenazate. EPA has authorized under FIFRA section 18 the use of bifenazate on greenhouse grown tomatoes for control of spider mites in Texas and Virginia. This regulation extends a time-limited tolerance for combined residues of bifenazate (hydrazine carboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl-, 1-methylethyl ester) and diazenecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl-, 1-methylethyl ester)) in or on tomato at 0.70 parts per million (ppm) for an additional 2-year period. This tolerance will expire and is revoked on June 30, 2005. A time-limited tolerance was originally published in the Federal Register of June 29, 2001 (66 FR 34561) (FRL-6788-5) (40 CFR 180.572).

Recently, EPA has received objections to a tolerance it established for bifenazate 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. Similar objections were filed by NRDC concerning a tolerance for imidacloprid, another pesticide addressed in this notice. Although these objections concern separate rulemaking proceedings under the FFDCA, EPA has considered whether it is appropriate to extend the emergency exemption tolerances for bifenazate and imidacloprid 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 extending 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 EPA has just initiated a 60-day public comment period on them in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-7). Second, the nature of the current actions are extremely time-sensitive as they address emergency situations. 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 extending the tolerances for bifenazate and imidacloprid.

2. Coumaphos. EPA has authorized under FIFRA section 18 the use of coumaphos in beehives for control of varroa mites and small hive beetles in Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. This regulation extends time-limited tolerances for the combined residues of the insecticide coumaphos ( O , O -diethyl O -3-chloro-4-methyl-2-oxo-2 H -1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon ( O , O -diethyl O -3-chloro-4-methyl-2-oxo-2 H -1-benzopyran-7-yl phosphate in or on honey at 0.1 ppm and beeswax at 100 ppm for an additional 2-year period. These tolerances will expire and are revoked on December 31, 2004. Time-limited tolerances were originally published in the Federal Register of August 16, 2000 (65 FR 49927) (FRL-6738-3) (40 CFR 180.189).

3. Dimethenamid. EPA has authorized under FIFRA section 18 the use of dimethenamid on dry bulb onion for control of yellow nutsedge and other broadleaf weeds in New York and Wisconsin. This regulation extends a time-limited tolerance for residues of the herbicide dimethenamid, 2-chloro- N -[(1-methyl-2-methoxy)ethyl]- N -(2,4-dimethylthien-3-yl)-acetamide in or on dry bulb onion at 0.01 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2004.

EPA has authorized under FIFRA section 18 the use of dimethenamid on sugar beets for control of weeds in Colorado, Minnesota, Nebraska, North Dakota, and Wyoming. This regulation extends the time-limited tolerances for residues of the herbicide dimethenamid, 2-chloro- N -[(1-methyl-2-methoxy)ethyl]- N -(2,4-dimethylthien-3-yl)-acetamide in or on beet, sugar at 0.01 ppm; beet, sugar, dried pulp at 0.05 ppm; beet, sugar, molasses at 0.05 ppm; and beet, sugar, tops at 0.01 ppm for an additional 2-year period. These tolerances will expire and are revoked on December 31, 2004. Time-limited tolerances were originally published in the Federal Register of August 24, 2000 (65 FR 51544) (FRL-6738-1) (40 CFR 180.464).

4. Diuron. EPA has authorized under FIFRA section 18 the use of diuron in commercial catfish ponds for control of blue-green algae ( Oscillatoria chalybea ) in Alabama and Mississippi. This regulation extends a time-limited tolerance for residues of the herbicide diuron (3-(3,4-dichlorophenyl)-1,1-dimethylurea) in or on catfish fillets at 2.0 ppm for an additional 2-year period. This tolerance will expire and is revoked on June 30, 2005. The time-limited tolerance was originally published in the Federal Register of July 30, 1999 (64 FR 41297) (FRL- 6087-2) (40 CFR 180.106).

5. Emamectin benzoate. EPA has authorized under FIFRA section 18 the use of emamectin benzoate on cotton for control of beet armyworm in New Mexico, Oklahoma, and Texas. This regulation extends the time-limited tolerances for residues of the insecticide emamectin benzoate in or on cotton, gin by-product at 0.025 ppm; cotton, hulls at 0.004 ppm; cotton, meal at 0.002 ppm; cottonseed at 0.002 ppm; cottonseed oil at 0.006 ppm; meat, fat, and meat by-product of cattle, goats, hogs, and sheep at 0.002 ppm; and milk at 0.002 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2004. Time-limited tolerances were originally published in the Federal Register of January 12, 2000 (65 FR 1796) (FRL-6398-5) (40 CFR 180.505).

6. Fenbuconazole. EPA has authorized under FIFRA section 18 the use of fenbuconazole on blueberries for control of mummy berry disease in Georgia. This regulation extends a time-limited tolerance for combined residues of the fungicide fenbuconazole alpha-[2-(4-chlorophenyl)-ethyl]-alpha-phenyl-3-(1 H -1,2,4-triazole)-1-propanenitrile] and its metabolites cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1 H -1,2,4-triazole-1-ylmethyl)-2-3 H -furanone and trans-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1 H -1,2,4-triazole-1-ylmethyl-2-3 H -furanone expressed as fenbuconazole in or on blueberries at 1.0 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2004. The time-limited tolerance was originally published in the Federal Register of June 10, 1998 (63 FR 31633) (FRL-5791-5) (40 CFR 180.480).

7. Fluroxypyr 1-methylheptyl ester. EPA has authorized under FIFRA section 18 the use of fluroxypyr 1-methylheptyl ester on grass pasture and rangeland for control of sericea lespedeza ( Lespedeza cuneata ) in Kansas. This regulation extends time-limited tolerances for combined residues of the herbicide fluroxypyr 1-methylheptyl ester 1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid in or on grass, forage at 120 ppm; grass hay at 160 ppm; kidney, cattle at 1.5 ppm; kidney, goat at 1.5 ppm; kidney, hog at 1.5 ppm; kidney, horse at 1.5 ppm; kidney, sheep at 1.5 ppm; and milk at 0.30 ppm for an additional 1 ½ year period. These tolerances will expire and are revoked on December 31, 2004. Time-limited tolerances were originally published in the Federal Register of September 17, 2001 (66 FR 47964) (FRL-6798-5) (40 CFR 180.535).

8. Hexythiazox. EPA has authorized under FIFRA section 18 the use of hexythiazox on dates for control of Banks grass mite in California. This regulation extends a time-limited tolerance for combined residues of the miticide hexythiazox, trans-5-(4-chlorophenyl)- N -cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as ppm of the parent compound) in or on dates at 0.1 ppm for an additional 2-year and 2-month period. This tolerance will expire and is revoked on December 31, 2004. The time-limited tolerance was originally published in the Federal Register of October 13, 1998 (63 FR 54594) (FRL-6030-3) (40 CFR 180.448).

9. Imidacloprid. EPA has authorized under FIFRA section 18 the use of imidacloprid on strawberries for control of white grubs in Connecticut. This regulation extends a time-limited tolerance for combined residues of the insecticide 1-[6-chloro-3-pyridinyl)methyl]- N -nitro-2-imidazolidinimine and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent in or on strawberries at 0.1 ppm for an additional 2-year and 6-month period. This tolerance will expire and is revoked on December 31, 2004. A time-limited tolerance was originally published in the Federal Register of January 20, 1999 (64 FR 3037) (FRL-6051-6) (40 CFR 180.472).

10. Metolachlor. EPA has authorized under FIFRA section 18 the use of s-metolachlor on spincah for control of weeds in Colorado, Delaware, New Jersey, Oklahoma, Pennsylvania, Texas, and Virginia. This regulation extends a time-limited tolerance for combined residues (free and bound) of the herbicide metolachlor [2-chloro- N -(2-ethyl-6-methylphenyl)- N -(2-methoxy-1-methylethyl)acetamide] and its metabolites, determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound in or on spinach at 0.3 ppm for an additional 2-year and 6-month period. This tolerance will expire and is revoked on December 31, 2004. The time-limited tolerance was originally published in the Federal Register of November 29, 1996 (61 FR 60617) (FRL-5574-7) (40 CFR 180.368).

EPA has authorized under FIFRA section 18 the use of s-metolachlor on tomatoes for control of weeds in California, Indiana, Maryland, Michigan, New Jersey, Ohio, Pennsylvania, and Virginia. This regulation extends time-limited tolerances for combined residues (free and bound) of the herbicide metolachlor [2-chloro- N -(2-ethyl-6-methylphenyl)- N -(2-methoxy-1-methylethyl)acetamide] and its metabolites, determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2- hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound in or on tomato paste at 0.6 ppm, tomato puree at 0.3 ppm and tomatoes at 0.1 ppm for an additional 2-year and 6-month period. These tolerances will expire and are revoked on December 31, 2004. The time-limited tolerance was originally published in the Federal Register of March 10, 1999 (64 FR 11782) (FRL-6062-5) (40 CFR 180.368).

11. Myclobutanil. EPA has authorized under FIFRA section 18 the use of myclobutanil on sugar beets for control of powdery mildew in Utah. This regulation extends a time-limited tolerance for combined residues of the fungicide myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1 H -1,2,4-triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1 H -1,2,4-triazole-1-propanenitrile (free and bound) in or on dried pulp of sugar beets at 1.0 ppm, sugar beet molassess at 1.0 ppm, refined sugar from sugar beets at 0.70 ppm, sugar beet roots at 0.05 pmm, and sugar beet tops at 1.0 ppm for an additional 2-year period. These tolerances will expire and are revoked on December 31, 2004. The time-limited tolerance was originally published in the Federal Register of January 3, 2001 (66 FR 298) (FRL-6757-9) (40 CFR 180.443).

EPA has authorized under FIFRA section 18 the use of myclobutanil on artichokes for control of powdery mildew in California. This regulation extends a time-limited tolerance for combined residues of the fungicide myclobutanil, alpha-butyl-alpha-(4-chlorophenyl)-1 H -1,2,4-triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1 H -1,2,4-triazole-1-propanenitrile (free and bound), in or on atichokes at 1.0 ppm for an additional 2-year period. This tolerance will expire and is revoked on June 30, 2005. The time-limited tolerance was originally published in the Federal Register of September 16, 1998 (63 FR 49472) (FRL-6025-1) (40 CFR 180.443).

12. Pendimethalin. EPA has authorized under FIFRA section 18 the use of pendimethalin on mint for control of kochia and redroot pigweed in Idaho, Oregon, and Washington. This regulation extends a time-limited tolerance for combined residues of the herbicide pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite in or on fresh mint hay and mint oil at 0.1 and 5.0 ppm for an additional 2 ½ year period. This tolerance will expire and is revoked on June 30, 2005. The time-limited tolerance was originally published in the Federal Register of May 23, 1997 (62 FR 28355) (FRL-5718-5) (40 CFR 180.361).

13. Sulfentrazone. EPA has authorized under FIFRA section 18 the use of sulfentrazone on lima beans and cowpeas for control of Hophornbeam Copperleaf in Tennessee. This regulation extends a time-limited tolerance for combined residues of the herbicide sulfentrazone and the metabolites 3-hydroxymethyl sulfentrazone and 3-desmethyl sulfentrazone in or on succulent bean seed without pod at 0.1 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2004. The time-limited tolerance was originally published in the Federal Register of September 21, 1999 (64 FR 51060) (FRL-6097-8) (40 CFR 180.498).

14. Tebuconazole. EPA has authorized under FIFRA section 18 the use of tebuconazole on sunflowers for control of rust ( Puccinia helianthi ) in North Dakota. This regulation extends time-limited tolerances for residues of the fungicide tebuconazole (alpha-[2-4-chlorophenyl)-ethyl]-alpha-(1,1-dimethylethyl)-1 H -1,2,4-triazole-1-ethanol) in or on sunflower oil at 0.4 ppm and sunflower seed at 0.2 ppm for an additional 2 ½ year period. This tolerance will expire and is revoked on December 31, 2005. The time-limited tolerance was originally published in the Federal Register of October 29, 1997 (62 FR 56089) (FRL-5752-4) (40 CFR 180.474).

15. Thiabendazole. EPA has authorized under FIFRA section 18 the use of thiabendazole on lentils for control of Ascochyta blight in Idaho, Montana, North Dakota, Oregon, and Washington. This regulation extends a time-limited tolerance for residues of the fungicide thiabendazole in or on lentils at 0.1 ppm for an additional 2-year period. This tolerance will expire and is revoked on December 31, 2004. The time-limited tolerance was originally published in the Federal Register of February 25, 1998 (63 FR 9435) (FRL-5767-6) (40 CFR 180.242).

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-2002-0112 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 16, 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 III.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0112; to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes time-limited tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, 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 under FFDCA section 408(l)(6) in response to an exemption under FIFRA section 18, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). 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 docket for this action under docket ID number OPP-2002-0093. The official docket 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). Interested parties should consult both 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 docket does not include any information claimed as CBI. The public version of the official docket, 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.

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

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

This extension of the temporary exemption from the requirement of a tolerance is associated with an extension of an Experimental Use Permit (69224-EUP-1), which was granted in May 1996 to the Southern Regional Research Center, United States Department of Agriculture, Agricultural Research Service (USDA ARS), 1100 Robert E. Lee Blvd., New Orleans, LA 70179-0687. Both the temporary exemption from tolerance and the Experimental Use Permit in Arizona expire December 30, 2003.

In the Federal Register of (March 25 2002, 57 FR 13628) (FRL-6827-8), EPA issued a notice 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 an amended pesticide tolerance petition (PP 5E4575) by Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology Center of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390 on behalf of the USDA/ARS Southern Regional Research Center, 1100 Robert E. Lee Blvd., P.O. Box 19687, New Orleans, LA 70179. This notice included a summary of the petition prepared by the petitioner, Dr. Michael Braverman. It referred to data previously evaluated and summarized by the Agency as published in the Federal Register of May 26 1999 (64 FR 28371) (FRL-6081-2), and the extension of the temporary tolerance exemption as published in the Federal Register of May 23 2001 (66 FR 28383) (FRL-6781-7). The petition requested that 40 CFR part 180.1206 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 on cotton in certain counties in Texas in addition to the current exemption from temporary tolerance on cotton in Arizona. This petition also, requested that this temporary exemption from a tolerance be extended to December 30, 2005.

Several comments were received in favor of the amendment to allow use of the microbial pesticide in Texas. The growers were of the opinion that the use of this active ingredient is likely to reduce the high levels of naturally occurring aflatoxin-producing strain. Aspergillus flavus AF36 has been found at a range of less than 1 to approximately 5% in certain regions of Texas.

One comment was received requesting the Agency to re-evaluate the science of the proposed program and that the risks associated with the use of the active ingredient be considered before a permanent exemption from a tolerance is issued. The main concerns in this comment were the requirement for uniform standards in the expression of aflatoxin levels found in the crop; the practical significance of the proposed treatment method in reducing aflatoxin contamination; and the significance of the host stress in the expression of pathogenicity by Aspergillus flavus.

Considering each of these points, first, the commenter referred to the mixing of units used to measure aflatoxin contamination. This comment specifically referred to the experimental researcher's reports, which include measurement of aflatoxin levels as micrograms per gram of cottonseed rather than the typical expression of micrograms per kilogram of cottonseed. In data submitted to the Agency, there is no indication that the company was in error or misrepresenting the aflatoxin values. In all cases, EPA is careful to pay close scrutiny to the units of measure in data they review and the implications made from the stated values.

Secondly, the efficacy of the pesticidal product to reduce the level of aflatoxin in commercial crops was questioned in the comments. The Agency requires that the company present data to confirm their claim to control a public health hazard. The submitted data are available in the public docket and have been reviewed. These data indicate that when Aspergillus flavus AF36 is used, a higher percentage of the treated commodity meets, or is less than, the standards of aflatoxin required by the Food and Drug Administration (FDA), and the aflatoxin contamination in the experimental region is lowered. The growers ultimately decide if the reduced aflatoxin contamination is worth the treatment cost, but all cotton and its by-products sold for food/feed must meet the FDA aflatoxin standard.

Regarding testing of the atoxigenic fungus, Aspergillus flavus AF36, on stressed or immunosuppressed species to detect any pathogenic potential in plants, insects, or mammals, EPA's guideline requirements are designed to address the normal immune response to microbial exposure. These tests include non-self/foreign recognition and response or clearance by the immune system over time. EPA is examining new methods that may address the potential of a microbe to infect stressed or immunocompromised hosts. In the interim, special measures have been included in the experimental treatments to reduce exposure to Aspergillus flavus AF36 outside of the designated treatment areas. The experimental plan also requires extensive data collection to examine the fate and persistence of Aspergillus flavus AF36 as a component of the local fungal population.

Exposure to Aspergillus flavus is inevitable, because the fungus normally occurs in the environment. Given the ubiquitous nature of various strains of Aspergillus flavus, the precautions associated with this experimental program, data indicating no undue adverse health effects to test rodent species by oral ingestion of Aspergillus flavus AF36, as well as the current FDA monitoring of aflatoxin levels, there is a reasonable certainty of no harm resulting from the use of the non-aflatoxin-producing fungus, Aspergillus flavus AF36.

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

Based on the data and analyses outlined in the Federal Register of May 26 1999 (66 FR 28371), and summarized below, EPA has concluded that there is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to residues of Aspergillus flavus AF36 arising from the limited use pattern of the experimental use permit. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.

1. Food. The cultural practice allows application of the microbial pesticide prebloom to cotton. This precludes the potential for direct residues of Aspergillus flavus AF36 per se to remain on the treated cotton. Only the seed of the treated commodity, cotton, is likely to be processed as food for cottonseed oil. Residues of Aspergillus flavus AF36 or its metabolites are likely to be removed from cotton seed oil during this processing.

In addition, the data submitted demonstrate that the proposed strain of Aspergillus flavus AF36, has a low toxicity potential, and, therefore, is likely to pose a minimal to non-existent hazard if used as labeled. The acute oral LD 50 of rats treated by gavage for 14 days is greater than 5,000 mg/kg. Further, the proposed strain of Aspergillus flavus, AF36, does not produce aflatoxin. Aflatoxin is regulated on the by-products of cotton by the Food and Drug Administration. The May 23 2001 Federal Register Notice also, discusses that no adverse effects were reported in the annual reports of the Experimental Use Permit 69224-EUP-1, and, in some instances, aflatoxin levels of cotton seed were reduced in treated cotton (May 23, 2001, 66 FR 28383).

2. Dermal exposure. Non-occupational dermal exposure and risk to adults, infants and children are not likely if the pesticide is used as labeled. If the microbe exhibits dermal sensitizing properties which is associated with this genus of fungi, the boundaries are likely to maintain distribution near treated areas thus protecting nearby at-risk populations. To further minimize exposure to immunocompromised or sensitive populations, infants and children, the Agency continues to require that the pesticide must not be applied within a boundary of 400 feet of schools, daycare and health care facilities and hospitals.

3. Inhalation exposure. Based on the method of application to the soil of cultivated cotton fields, prebloom with set boundaries, non-occupational inhalation exposure and risk to human adults, children and infants are likely to be minimal.

4. Determination of safety for U.S. population, infants and children. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure (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 unless EPA determines that a different margin of exposure (safety) will be safe for infants and children. In this instance, based on the above findings, EPA believes there are reliable data to support the conclusion that there are no threshold effects of concern to infants, children, and adults when Aspergillus flavus AF36 is used as labeled, and that no additional margin of exposure is necessary.

5. Cumulative effects. This is the only microbe in the genus Aspergillus which is in an experimental use program at this time. Aspergillus species are naturally occurring ubiquitous fungi, such that exposure to various species is normal. The data submitted to the Agency support the claim that Aspergillus flavus AF36 is non-aflatoxin producing. When applied prior to flowering, Aspergillus flavus has been shown to exclude aflatoxin-producing fungi competitively from the developing crop and to reduce aflatoxin contamination of cottonseed. Data show that the proposed use will not result in appreciable increases in the long-term populaton of Aspergillus flavus on the crop beyond naturally occurring levels. Furthermore, there is no expectation of cumulative effects with other pesticides.

1. Endocrine disruptors. EPA does not have any information regarding endocrine effects of this microbial pesticide at this time.

2. Analytical methods. Starter cultures are screened on the basis of vegetative incompatibility with the toxigenic strain. Aspergillus flavus AF 36 does not demonstrate vegetative compatibility with the aflatoxin-producing S strain. Aflatoxin production is monitored by standard thin layer chromatography (tlc) procedures and visualization via scanning fluorescence densitometry and there is a zero tolerance for aflatoxin. Human pathogens are reported to be within regulatory levels (May 26 1999, 64 FR 28371). Treated cotton and its by-products are screened for aflatoxin prior to introduction into the channels of commerce. FDA does not allow cotton seed products containing aflatoxin above 20 parts per billion (ppb) to be used in dairy rations or above 300 ppb to be used for feeding beef cattle.

3. Codex maximum residue level. There is no codex maximum residue level for Aspergillus flavus AF36.

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-2002-0093 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 September 16, 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 VIII.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-2002-0093, 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 an amended exemption from the temporary tolerance requirement 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 (October 4 1993, 58 FR 51735). 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 (May 22 2001, 66 FR 28355). 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 (February 16 1994, 59 FR 7629); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (April 23 1997, 62 FR 19885). 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 amended temporary tolerance exemption 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 (August 10 1999, 64 FR 43255). 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 (November 6, 2000, 65 FR 67249). 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-2002-0085. 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 August 1, 2001 (66 FR 39709) (FRL-6787-3), EPA issued a proposed rule to revoke the tolerances listed in this final rule. Also, the August 1, 2001 proposal invited public comment for consideration and for support of tolerance retention under FFDCA standards.

This final rule revokes certain FFDCA tolerances for residues of the insecticides phosphamidon and trimethacarb; the herbicides atrazine, bensulide, diphenamid, and vernolate; the fungicide imazalil; and the fungicide/insecticide oxythioquinox in or on specified commodities listed in the regulatory text because these pesticides are not registered under FIFRA for uses on those commodities. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on certain domestically treated commodities or commodities treated outside but imported into the United States. These pesticides are no longer used on those specified commodities within the United States. No one commented that there was a need for EPA to retain these tolerances to cover residues in or on imported foods. EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.

Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed above if: (1) Prior to EPA's issuance of a section 408(f) order requesting additional data or issuance of a section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained; (2) EPA independently verifies that the tolerance is no longer needed, or (3); the tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.

This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. In response to the proposal published in the Federal Register of August 1, 2001 (66 FR 39709), EPA did receive comment regarding the need to retain carbofuran tolerances and fumaric acid tolerance exemptions, as follows:

1. Carbofuran. EPA received a comment from FMC Corporation, who expressed opposition to the proposed revocation of the rice and rice, straw tolerances on the basis of a 1991 settlement agreement reached between FMC and EPA. Also, FMC cited use of carbofuran for control of rice pests in numerous countries and stated that the rice tolerances should be retained to allow importation of carbofuran-treated rice.

Agency response. In 1999, EPA notified FMC Corporation that the Agency would not authorize any further production of granular carbofuran for rice in the 1999 season and beyond. Distribution, sale, and use of existing stocks of granular carbofuran on rice after August 31, 1999, were prohibited except in California, where due to unique transition issues, rice growers in California were permitted to use existing stocks of carbofuran on rice until August 2000. On August 1, 2001 (66 FR 39709), EPA proposed to revoke the tolerances for residues of the insecticide carbofuran and its metabolites in or on rice and rice, straw with an expiration/revocation date of August 31, 2002 to allow treated commodities to pass through the channels of trade. Because in a comment to the proposed rule, FMC Corporation expressed a need for the retention of these tolerances for import purposes and because FMC agreed to support these tolerances according to EPA's guidance on pesticide import tolerances and residue data for imported food published in the Federal Register of June 1, 2000 (65 FR 35069) (FRL-6559-3), EPA will not revoke the tolerances in 40 CFR 180.254 for rice and rice, straw at this time. When the submitted data have been reviewed, EPA will re-evaluate these tolerances under FFDCA. If these data requirements are not met, EPA will finalize the revocation of the carbofuran rice tolerances.

Concerning fumaric acid, the following comment was received:

2. Fumaric acid . EPA received a comment from Keller and Heckman LLP, who on behalf of a client, requested the retention of the current exemptions for fumaric acid in 40 CFR 180.2. The commenter stated that a client will, in the near future, submit an application for the registration of a pesticide containing fumaric acid. Also, the commenter claimed that since fumaric acid had been reassessed and determined to be safe by EPA and that additional data to support the exemptions need not be required. In addition, the commenter asked that his comments be considered a petition to establish an inert tolerance exemption in 40 CFR 180.1001(d) as a reinstatement for an exemption revoked in a final rule published in the Federal Register of October 26, 1998 (63 FR 57062) (FRL-6035-8).

Agency response. EPA is still evaluating the issues described in the comment. Therefore, at this time, EPA will not take final action on the tolerance exemptions in 40 CFR 180.2 for residues of the fungicide fumaric acid on raw agricultural commodities and on animal products or in 40 CFR 180.1001(d) on the tolerance exemption for the inert use of fumaric acid-isophthalic acid-styrene-ethylene/propylene glycol copolymer in pesticide formulations applied to growing crops only.

No comments were received by the Agency concerning the following.

3. Atrazine . The Agency is revoking the tolerances in 40 CFR 180.220 for use of atrazine and its metabolites on orchardgrass and orchardgrass hay because atrazine is no longer registered for these uses. EPA proposed these tolerance revocations in the Federal Register of August 1, 2001 (66 FR 39709) and also previously on February 5, 1998 (63 FR 5907) (FRL-5743-9). In response to a comment in 1998 from the Washington State Department of Agriculture that active registrations for atrazine use on grass existed, EPA did not take final action on the tolerances in 40 CFR 180.220 for use of atrazine on grass, range; orchardgrass; and orchardgrass, hay as published in the Federal Register (63 FR 57067, October 26, 1998) (FRL-6035-6). However, the orchardgrass use for atrazine was canceled in 1989 due to non-payment of maintenance fees and therefore the tolerances should be revoked. EPA believes that sufficient time has passed for exhaustion of stocks for those labeled uses and for treated commodities to have cleared channels of trade. Also, in 40 CFR 180.220, EPA is removing the “(N)” designation from all entries to conform to current Agency administrative practice (“N” designation means negligible residues).

At this time, EPA will not take final action on the tolerance in 40 CFR 180.220 for use of atrazine and its metabolites on “grass, range” because there are existing 24(c) food-use registrations.

4. Bensulide . EPA is revoking the tolerance for residues of the herbicide S -( O , O -Diisopropyl phosphorodithioate) ester of N -(2-mercaptoethyl) benzenesulfonamide, known as bensulide, and its oxygen analog in or on cottonseed in 40 CFR 180.241 because bensulide is not registered under FIFRA for use on cotton. On September 30, 1994, a 6(f)(1) notice of receipt of the voluntary use deletion request by the registrant was published in the Federal Register (59 FR 34065) (FRL-4912-1). EPA believes that existing stocks have been used and any treated commodity has passed through the channels of trade.

5. Diphenamid . Diphenamid has not had active registrations under FIFRA since 1991. EPA believes that existing stocks have been used and any treated commodity has passed through the channels of trade. EPA is revoking the tolerances in 40 CFR 180.230 for residues of the herbicide diphenamid and its metabolite in or on apples; cattle, fat; cattle, mbyp; cattle, meat; cotton forage; cottonseed; fruiting vegetables; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; milk; okra; peaches; peanut forage; peanut hay; peanuts; potatoes; sheep, fat; sheep, mbyp; sheep, meat; raspberries; soybean forage; soybean hay; soybeans; strawberries; and sweet potatoes. Therefore, the Agency is removing 40 CFR 180.230 in its entirety.

6. Imazalil . On May 24, 2000 (65 FR 33703) (FRL-6041-9), the tolerance for cottonseed, formerly codified in 40 CFR 180.413(a) was recodified in 40 CFR 180.413(a)(1). EPA is revoking the tolerance in 40 CFR 180.413(a)(1) for the combined residues of the fungicide imazalil and its metabolite in or on cottonseed because imazalil is not registered under FIFRA for use on cotton. There have been no active registrations for imazalil use on cotton commodities since December 1991.

7. 6-Methyl-1,3-dithiolo[4,5-b]quinoxalin-2-one . Because the fungicide/insecticide 6-methyl-1,3-dithiolo[4,5-b] quinoxalin-2-one (oxythioquinox) has no registered uses under FIFRA, EPA is revoking the tolerances in 40 CFR 180.338 for residues of oxythioquinox in or on apples; apricots; cattle, fat; cattle, mbyp; cattle, meat; citrus fruits; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; macadamia nuts; milk; pears; sheep, fat; sheep, mbyp; sheep, meat; and walnuts. In the Federal Register of March 17, 1999 (64 FR 13191) (FRL-6067-8), EPA announced receipt of a request for voluntary cancellation of oxythioquinox, also known as chinomethionate. The Agency permitted distribution and sale for 18 months after the effective date of cancellation on October 27, 1999, and end users were permitted an additional year for use of existing stocks.

On August 1, 2001 (66 FR 39709), EPA proposed an expiration/revocation date of August 1, 2002, for the 22 tolerances for oxythioquinox in 40 CFR 180.338, to allow any treated commodities to pass through the channels of trade. No comment was received on oxythioquinox. The Agency is revoking these oxythioquinox tolerances effective 90 days following publication of this final rule in the Federal Register , which is October 15, 2002.

8. Phosphamidon . EPA is revoking the tolerance in 40 CFR 180.239 for residues of the insecticide phosphamidon including all of its related cholinesterase-inhibiting compounds in or on apples with an expiration/revocation date of December 31, 2002, to allow any treated commodities to pass through the channels of trade.

EPA proposed this tolerance revocation for phosphamidon in the Federal Register of August 1, 2001 (66 FR 39709) and also, previously on January 21, 1998 (63 FR 3057) (FRL-5743-8). In 1998, comments were received from the Washington State Department of Agriculture and Northwest Wholesale, Inc. which requested that EPA not revoke the tolerance for phosphamidon on apples due to concerns about existing stocks. The Agency did not revoke the tolerance for phosphamidon on apples at that time (63 FR 57062, October 26, 1998) (FRL-6035-8). Subsequently, the Agency was informed by the Washington State Department of Agriculture that based on review of the pests controlled by phosphamidon, efficacy of registered alternatives, estimates of remaining stocks of phosphamidon, and use/disposal of remaining unused stocks, retention of the tolerance for phosphamidon on apples until December 31, 2002, would allow growers to use up existing stocks and allow treated apples to pass through the channels of trade.

Therefore, EPA is revoking the tolerance in 40 CFR 180.239 for residues of phosphamidon including all of its related cholinesterase-inhibiting compounds in or on apples with an expiration/revocation date of December 31, 2002. Because the tolerance with its revocation date will remain in 40 CFR 180.239, EPA is also revising the commodity name from “apples” to “apple” in order to conform to current Agency administrative practice.

9. S-Propyl dipropylthiocarbamate . Because there are no registered uses for S -Propyl dipropylthiocarbamate (vernolate), EPA is revoking the tolerances in 40 CFR 180.240 for vernolate residues in or on corn, fodder; corn, forage; corn, fresh (inc. sweet)(K+CWHR); corn, grain; peanuts; peanut, forage; peanut, hay; potatoes; soybeans; soybean, forage; soybean, hay; and sweet potatoes. In the notice of receipt of the request for voluntary cancellation of vernolate, EPA agreed that registrants were permitted to sell and distribute existing stocks of vernolate until February 1, 2000; that distributors were permitted to sell and distribute existing stocks of vernolate until February 1, 2001; and that end users are permitted to use existing stocks until February 1, 2002 (March 3, 1999, 64 FR 10296) (FRL-6061-9).

On August 1, 2001 (66 FR 39709), EPA proposed an expiration/revocation date of May 1, 2002 for all vernolate tolerances in 40 CFR 180.240. No comment was received on vernolate. Because that date has passed, the Agency is revoking these vernolate tolerances effective 90 days following publication of this final rule in the Federal Register, which is October 15, 2002, to ensure that all affected parties receive notice of EPA's actions.

10. Trimethacarb . EPA is revoking the tolerance for residues of the insecticide 3,4,5-trimethylphenyl methylcarbamate and 2,3,5-trimethylphenyl methylcarbamate, known as trimethacarb, in or on corn, field, grain; corn, fodder; corn, forage; and corn, pop, grain in 40 CFR 180.305 because trimethacarb is no longer registered under FIFRA for use on corn. Therefore, the Agency is removing 40 CFR 180.305 in its entirety.

EPA proposed these tolerance revocations for trimethacarb in the Federal Register of August 1, 2001 (66 FR 39709) and also previously on January 21, 1998 (63 FR 3057). In 1998, a comment was received from Drexel Chemical Company which requested that EPA not revoke the tolerances for trimethacarb until Drexel determined the state of existing stocks. As a result of that comment, the Agency did not take action on trimethacarb at that time (October 26, 1998, 63 FR 57062). Subsequently, the Agency was informed by Drexel that end-users would exhaust existing stocks of trimethacarb by mid-May 1999. Therefore, the Agency is making the revocations as given in the regulatory text.

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

The tolerance for phosphamidon on apples expires on December 31, 2002. With the exception of the aforementioned pesticide tolerance revocation, the remaining tolerance revocations for atrazine, bensulide, diphenamid, imazalil, 6-methyl-1,3-dithiolo[4,5-b]quinoxalin-2-one (oxythioquinox), S -propyl dipropylthiocarbamate (vernolate), and trimethacarb are effective 90 days following publication of this final rule in the Federal Register, which is October 15, 2002, to ensure that all affected parties receive notice of EPA's actions. For this final rule, tolerances that were revoked because registered uses did not exist concerned uses which have been canceled for more than a year. Therefore, commodities containing these pesticide residues should have cleared the channels of trade.

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

By law, EPA is required by August 2002 to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996. EPA is also required to assess the remaining tolerances by August 2006. As of July 1, 2002, EPA has reassessed over 5,400 tolerances. In this final rule, EPA is revoking a total of 75 tolerances which count as reassessments toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Decisions. EPA has developed guidance concerning submissions for import tolerance support (June 1, 2000, 65 FR 35069) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov/. On the Home Page select “Laws and Regulations,” then select Regulations and Proposed Rules,” and then look up the entry for this document under “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

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-2002-0085 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 September 16, 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. Objection/hearing 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 IV.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0085, 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 will revoke tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (i.e., a tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final 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 as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, I certify that this action will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with canceled pesticides. Furthermore, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis.

In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This 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 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 ID number OPP-2002-0129. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of April 17, 2002 (67 FR 18890) (FRL-6830-9), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of pesticide petitions (PP 1E6351, 2E6394, and 2E6396) by IR4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390, and pesticide petitions (PP 5F4440 and 5F4572) by Valent U.S.A. Corporation, 1333 North California Boulevard, Suite 600, Walnut Creek, CA 94596-8025. This notice included a summary of the petitions prepared by Valent U.S.A. Corporation, the registrant. There were no comments received in response to the notice of filing. The petitions requested that 40 CFR 180.458 be amended by establishing tolerances for residues of the herbicide clethodim, (E)-(±)-2-1-(3-chloro-2-propenyl)oxyiminopropyl-5-2-(ethylthio)propyl-3-hydroxy-2-cycloh exen-1-one and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones, in or on Brassica, leafy greens, subgroup 5B at 3.0 part per million (ppm), turnip greens at 3.0 ppm, peppermint and spearmint tops at 5.0 ppm, and spinach at 2.0 ppm.

The petitions also requested that 40 CFR 180.458 be amended by replacing existing timelimited tolerances, with permanent tolerances for residues of the herbicide clethodim, (E)-(±)-2-1-(3-chloro-2-propenyl)oxyiminopropyl-5-2-(ethylthio)propyl-3-hydroxy-2-cycloh exen-1-one and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones, in or on alfalfa forage at 6.0 ppm, alfalfa hay at 10 ppm, dry bean at 2.0 ppm, peanut at 3.0 ppm, peanut hay at 3.0 ppm, and peanut meal at 5.0 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 residues of clethodim on alfalfa forage at 6.0 ppm, alfalfa hay at 10 ppm, dry bean at 2.5 ppm, Brassica, leafy greens, subgroup at 3.0, peanut at 3.0 ppm, peanut hay at 3.0, peanut meal at 5.0, and turnip tops at 3.0 ppm, peppermint and spearmint tops at 5.0 ppm, and spinach at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follow.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by clethodim is discussed in Unit III.A. of the Federal Register of March 14, 2001 (66 FR 14829) (FRL-6770-8).

A summary of the toxicological endpoints for clethodim used for human risk assessment is discussed in Unit III.B of the Federal Register of March 14, 2001 (66 FR 14829) (FRL-6770-8). Chronic, and short-term, intermediate-term, and long-term aggregate risk assessments are appropriate for clethodim and were performed by EPA.

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.458) for the residues of clethodim, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from clethodim in food as follows:

i. Acute Exposure . Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. An endpoint was not identified for acute dietary exposure and risk assessment because no effects were observed in oral toxicity studies including developmental toxicity studies in rats or rabbits that could be attributable to a single dose (exposure). Therefore, an acute dietary exposure assessment was not performed.

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: Chronic analysis used tolerance level residues for all crops and livestock commodities. The projected %% crop treated data (2%% for lettuce, broccoli and cauliflower, 15%% cabbage, and 1%% for brussels sprouts), and the weighted average %% crop treated data (3%% for cotton, 8%% for onions, 3%% for peanuts 4%% for soybeans, 15%% for sugar beets, and 1%% for tomatoes) were used for the analysis; 100%% crop treated (CT) data were assumed for the leafy Brassica greens, turnip greens, dry bean, peanuts, and the other crops for the analysis. DEEM default concentration factors were used for all commodities. The analysis is considered Tier 2 because percent of crop treated information was used.

iii. Cancer . Clethodim has been classified as a group E carcinogen. Therefore, a cancer risk assessment was not performed.

iv. Anticipated residue and percent crop treated information .

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

The Agency used percent crop treated (PCT) information as follows.

2%% for lettuce, broccoli and cauliflower; 15%% cabbage, and 1%% for brussels sprouts; (weighted average PCT) 3%% for cotton, 8%% for onions, 3%% for peanuts, 4%% for soybeans, 15%% for sugar beets, and 1%% for tomatoes.

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

2. Dietary exposure from drinking water .

The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for clethodim 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 clethodim.

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCIGROW model is used to predict pesticide concentrations in shallow groundwater. 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 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 clethodim they are further discussed in the aggregate risk sections III.E.

Summary: Surface and ground water contamination may occur from the sulfoxide and sulfone degradates of clethodim, as well as from parent clethodim. However, the risk of water contamination is primarily associated with clethodim sulfone and clethodim sulfoxide rather than parent clethodim based on greater persistence and mobility for the degradates. The drinking water estimates are based on a maximum application rate of 0.5 pounds of active ingredient per acre per year.

Surface Water: Parent clethodim may move from the treated field to surface water or ground water through run-off or leaching which occurs shortly after application (e.g. rainfall). Also, the sulfoxide and sulfone degradates may migrate by runoff or leaching for longer periods of time since they are more persistent. All residues of clethodim (parent and degradates) are very mobile in soil. Tier 1 surface water concentrations for parent clethodim and total toxic residues (parent + sulfoxide + sulfone) estimations are as follows:

Based on the FIRST model, the estimated environmental concentrations (EECs) of clethodim for acute exposure are estimated to be 38.9 parts per billion (ppb), and for chronic exposure the EECs are estimated to be 7.6 ppb for surface water.

Ground Water: Parent clethodim is mobile, but has a short metabolic half-life in soil under aerobic conditions. Therefore, parent compound should not be a ground water concern in most environments. While it is expected that parent clethodim be transformed to sulfoxide or sulfoxone products quickly by soil metabolism (t½ = 1 to 3 days), it may be more persistent since it is leached below the more biologically active top soil. In such instances (i.e., leaching rainfall shortly after application) parent clethodim concentrations may be higher than estimated. In the event that parent clethodim did reach ground water, the available routes of disappearance would be dilution, some metabolism to persistent degradates, and slow hydrolysis with the rate depending on the pH of the ground water. The estimation for both parent clethodim and total toxic clethodim (parent + sulfoxide+sulfone) is as follows: Based on the SCIGROW model, the EEC for ground water is 0.49 ppb.

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).

Clethodim is currently registered for use on the following noncrop sites: rights of way such as railroads, highways, roads, dividers, medians, pipelines, public utility lines, pumping stations, transformer stations and substations, around airports, electric utilities, commercial buildings, manufacturing plants, storage yards, rail yards, fence lines, parkways, greenhouse benches, and around golf courses (not on golf courses). It is possible that the public could be exposed to clethodim residues in these noncrop areas.

Homeowner use of clethodim is not prohibited on the label, therefore the Agency assumes clethodim products are available for use by untrained applicators. A residential handler assessment was performed to determine the risk potential to homeowners. The following assumptions were made in conducting the assessment: clethodim would be applied by low pressure handwand (spot treatment); the highest label rate of 1.3 ounces per gallon was used; five gallons of spray are used; applicators mix, load and apply; and short sleeved shirt and short pants are worn by homeowners.

Clethodim is typically used to control unwanted weeds of all types (grass and broadleaf) through spot treatment, usually resulting in a small treated area. Broadcast treatment is not expected. It is unlikely that adults and children would be exposed to treated areas which would most likely consist of a single spot. Therefore, a non-occupational post-application exposure assessment was not performed.

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 clethodim 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, clethodim 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 clethodim 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 oral perinatal and prenatal data demonstrated no indication of increased sensitivity of rats or rabbits to in utero exposure to clethodim.

3. Conclusion . There is a complete toxicity data base for clethodim 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 there is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure; a developmental neurotoxicity study is not required; and the dietary (food and drinking water) and non-dietary (residential) exposure assessments will not underestimate the potential exposures for infants and children.

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

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

1. Acute risk . An endpoint was not identified for acute dietary exposure and risk assessment because no effects were observed in oral toxicity studies including developmental toxicity studies in rats or rabbits that could be attributable to a single dose (exposure). Therefore, clethodim is not expected to pose an acute risk.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to clethodim from food will utilize 33%% of the cPAD for the U.S. population, 26%% of the cPAD for females 1350 years old and 66%% of the cPAD for children (16 years old). Based the use pattern, chronic residential exposure to residues of clethodim is not expected. In addition, there is potential for chronic dietary exposure to clethodim 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 1:

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

Clethodim 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 clethodim.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated resulted in an aggregate MOE of 29,000 for males (13 to 19 years old). The dietary exposure of all adult population subgroups is comparable to that of the subgroup with the highest exposure (males 13 to 19 years old). This aggregate MOE does 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 clethodim in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown below in Table 2. Additionally, no incidental oral exposure is anticipated for infants and children, since postapplication exposure is not expected.

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). Intermediate-term oral, dermal and inhalation aggregate risks are made up of exposures from these routes of exposure.

Although, clethodim is currently registered for use(s) that could result in intermediateterm residential exposure dermal, inhalation and incidental oral exposures were not calculated because neither handler nor post-application intermediate-term exposure for these routes of exposure are expected. Therefore, no intermediate-term risk is expected from these routes of exposure.

5. Aggregate cancer risk for U.S. population . Clethodim was negative for carcinogenicity in feeding studies in rats and mice and is classified as “not likely%rdquo; to be a human carcinogen.

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 clethodim residues.

Adequate methods are available for enforcement of tolerances for clethodim and its metabolites in/on Brassica, leafy greens, subgroup, turnip greens, and other commodities (including livestock). Analytical Method RM26B3 (a modification of RM26B2) has been successfully validated for use with many commodities including livestock commodities and has been submitted to the FDA for publication in PAM II.

Adequate enforcement methodology (example—gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, Environmental Protection Agency, 701 Mapes Road, Fort George G. Mead, MD 20755-5350; telephone number (410) 305-2905; griffith.francis@epa.gov.

There are no established Codex, Canadian, or Mexican maximum residue limits (MRLs) or tolerance for residues of clethodim in/on the commodities discussed in the subject petition; therefore, there are no questions with respect to Codex/U.S. tolerance compatibility.

Therefore, these tolerances are established for residues of clethodim, (E)-(±)-2-1-(3-chloro-2-propenyl)oxyiminopropyl-5-2-(ethylthio)propyl-3-hydroxy-2-cyclohexe n-1-one and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones, in or on alfalfa forage at 6.0 ppm, alfalfa hay at 10 ppm, dry bean at 2.5 ppm, Brassica, leafy greens, subgroup at 3.0 ppm, peanut at 3.0 ppm, peanut hay at 3.0 ppm, peanut meal at 5.0 ppm, and turnip greens at 3.0 ppm, peppermint and spearmint tops at 5.0 ppm, and spinach at 2.0 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 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-2002-0129 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 September 16, 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 email 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-2002-0129, 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 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 SUPPLEMENTARY INFORMATION .

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 control number OPP-2002-0068. 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.

This final rule revokes the FFDCA tolerances for residues of the fungicide benomyl in or on specified commodities listed in the regulatory text because benomyl is no longer registered under FIFRA for use on those commodities. The tolerances revoked by this final rule are no longer necessary to cover residues of benomyl in or on domestically treated commodities or commodities treated outside but imported into the United States. Benomyl is no longer used on those specified commodities within the United States, and no comments were received indicating that there was a need for EPA to retain any of the tolerances to cover benomyl residues in or on imported foods. EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus, it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person commenting on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.

In the Federal Register of January 15, 2002 (67 FR 1917) (FRL-6816-6), EPA issued a proposed rule to revoke the tolerances listed in this final rule. Also, the January 15, 2002 proposal provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards. If, during the 60-day public comment period, EPA receives comments indicating a need for the tolerance to be retained, EPA will not proceed with the revocation unless: (1) Prior to EPA's issuance of a section 408(f) order requesting additional data or issuance of a section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained, (2) EPA independently verifies that the tolerance is no longer needed, or (3) the tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.

In response to the document published in the Federal Register of January 15, 2002, EPA received comment from a private citizen that stated agreement with the revocation of benomyl tolerances and also received comments as follows:

1. Michigan Blueberry Growers Association (MBG) . A comment letter was received from MBG Marketing—Michigan Blueberry Growers Association (MBG). MBG stated that 70% of the Michigan blueberry crop is frozen after harvest and may be stored for several years before it is sold, further processed or consumed. MBG requested that the tolerance for use of benomyl on blueberry be retained until January 1, 2008, to allow time for existing stocks of benomyl to be used and benomyl-treated blueberries to clear channels of trade.

Agency response . The time frame which MBG has requested regarding the benomyl tolerance for blueberry is in agreement with what was proposed by the Agency on January 15, 2002. Therefore, EPA is revoking the tolerance in 40 CFR 180.294 for blueberry with an expiration/revocation date of January 1, 2008.

2. Gowan Company . A comment letter was received from the Gowan Company. Gowan stated that it had applied in June 2001 for registration of products containing the active ingredient benomyl and amended the application twice in January 2002. Gowan requested that, except for the “bean vine forage” tolerance, all tolerances for benomyl not be revoked. Also, Gowan stated its belief that no satisfactory substitutes for benomyl are available at the present time. In addition, Gowan agreed that the terminology for a large number of commodities requires updating.

Agency response . On June 12, 2001, EPA received applications from Gowan Company to register four products containing the active ingredient benomyl. Gowan applied for registration under the “me-too” provisions in FIFRA. On September 21, 2001, the Agency identified several deficiencies in Gowan's applications. Although Gowan submitted a response to these deficiencies in January 2002, their response is incomplete. Furthermore, because benomyl is no longer registered, for purposes of registration under FIFRA, benomyl is a “new chemical” and the “me-too” provisions outlined in section 3 of FIFRA are no longer applicable to an application for registration of benomyl. And so long as there are no registered uses, and no indication that commodities containing residues of the pesticide are being imported, there is no need for the tolerances to be maintained.

In this regard, Gowan's claim that there are no satisfactory substitutes for benomyl is irrelevant. Moreover, if the commenter is correct that there are no satisfactory alternatives, the continued existence of the tolerance would merely encourage the use of an unregistered pesticide. At any rate, the Agency disagrees with this claim and believes that, for the most part, acceptable alternatives exist. In fact, to facilitate the registration of benomyl alternatives, EPA has expedited the registration review for several new uses of the fungicide thiophanate-methyl, including grapes, pistachios, potatoes (foliar application), pears, canola, and celery. The Agency hopes to make a decision on these pending uses in the very near future. The Agency will continue to work with affected parties, including growers, the U.S. Department of Agriculture, and other registrants, to identify emerging alternatives to benomyl. Where emergency conditions, as defined under section 18 of FIFRA, exist, the Agency will work with States, growers, and registrants to try to make benomyl alternatives available prior to registration.

No comment was received which expressed a need for the retention of specific tolerances for import purposes. On August 8, 2001 (66 FR 41589) (FRL-6794-9), EPA published in the Federal Register a cancellation order for all benomyl product registrations effective August 8, 2001. The Agency allowed the registrant to sell and distribute benomyl stocks until June 30, 2001 and is allowing those other than the registrant to sell and distribute benomyl stocks until December 31, 2002. The Agency expects existing stocks to be exhausted by December 31, 2003. However, because no active registrations exist and because no commenters expressed a need to retain these tolerances for import purposes, EPA is revoking 100 benomyl tolerances.

Because bean vine forage is no longer a significant livestock feed item and the tolerance is no longer needed, EPA is revoking the tolerance for bean vine forage to become effective 90 days following publication of this final rule to ensure that all affected parties receive notice of EPA's actions. Also, to conform to current Agency practice, EPA is revising the commodity terminology for peanut forage (at 15.0 ppm) to peanut, hay. However, because a tolerance currently exists for peanut hay (at 15.0 ppm), the peanut forage tolerance is no longer needed. Therefore, EPA is also revoking the tolerance for peanut forage to become effective 90 days following publication of this final rule.

EPA is revoking all other benomyl tolerances in 40 CFR 180.294 with expiration/revocation dates from 3 to 6 years beyond the last date which EPA allowed those other than the registrant to sell and distribute existing stocks of benomyl product in order to allow sufficient time for the passage of benomyl-treated food in channels of trade. (The dates are 2 to 5 years beyond the time when EPA expects benomyl stocks to be exhausted). These dates were determined using available Agency data, U.S. Food and Drug Administration (FDA) data, and food industry data as follows:

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-2002-0118. 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.

This final rule revokes all tolerances for residues of methoxychlor. In the Federal Register of April 4, 2002 (67 FR 16073) (FRL-6828-8), EPA issued a proposed rule to revoke all methoxychlor tolerances because all registrations of pesticides containing methoxychlor are suspended or canceled, and there are insufficient data to find the pesticide safe in accordance with section 4(b)(2)(A) of FFDCA. The primary registrant of methoxychlor (Kincaid Enterprises, Inc.) has failed to submit the necessary data required to support continued registration of pesticide products containing methoxychlor. As a result, all methoxychlor products are currently suspended. The April 4, 2002 proposal invited public comment for consideration and for support of tolerance retention under FFDCA standards, but no comments were received during the 60-day comment period that changed the Agency's position concerning methoxychlor.

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

These actions become effective 90 days following publication of this final rule in the Federal Register. EPA has delayed the effectiveness of these revocations for 90 days following publication of this final rule to ensure that all affected parties receive notice of EPA's actions. Consequently, the effective date is October 15, 2002. For this final rule, EPA believes that all existing stocks of pesticide products labeled for the uses associated with the tolerances proposed for revocation have already been exhausted since such products have been suspended since June 26, 2000. Similarly, the Agency believes that commodities legally treated with methoxychlor have by this time cleared the channels of trade.

Any commodities listed in 40 CFR 180.120 that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this section, any residue of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that, the residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.

By law, EPA is required by August 2002 to reassess 66% or about 6,400 of the tolerances in existence on August 2 1996. EPA is also required to assess the remaining tolerances by August 2006. As of April 29 2002, EPA has reassessed over 4,140 tolerances. In this rule, EPA is revoking a total of 79 tolerances which count as reassessments toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Decisions. EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov/. On the Home Page select “Laws and Regulations,” then select “Regulations and Proposed Rules” and then look up the entry for this document under “ Federal Register —Environmental Documents.” You can also go directly to the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/.

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-2002-0118 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 September 16, 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. Objection/hearing 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 IV.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0118, 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 will revoke tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (i.e., a tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final 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 as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, I certify that this action will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with canceled pesticides. Furthermore, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis.

In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This 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 document in CC Docket No. 94-102, DA 02-1575; released July 3, 2002. The complete text of this document is available for inspection and copying during normal business hours in the FCC Reference Information Center, Courtyard Level, 445 12th Street, SW., Washington, DC, and also may 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 at qualexint@aol.com. Alternative formats (computer diskette, large print, audio cassettes, and Braille) are available to persons with disabilities by contacting Brian Millin at 202-418-7426, TTY 202-418-7365, or at bmillin@fcc.gov.

1. The Commission invites comment on a Petition for Reconsideration (Reconsideration Petition) of the Report and Order (R&O) in this proceeding in which the Commission addressed the issues associated with the inability of a Public Safety Answering Point (PSAP) to call back a 911 caller who is disconnected prematurely when that caller is using a non-service initialized wireless telephone (non-initialized phone). Non-initialized phones are handsets that are not registered for service with any Commercial Mobile Radio Service carrier and thus lack a dialable number. The R&O may be found at 67 FR 36112, May 23, 2002. The Reconsideration Petition was filed by the Emergency Services Interconnection Forum (ESIF), which also separately filed a Request for Stay (Stay Request) of the effective date (October 1, 2002) for 47 CFR 20.18(l)(1)(i) and (l)(2)(i), adopted in the R&O. The Commission also solicits comment on the Stay Request.

2. Section 20.18(l)(1)(i), requires that licensees donating non-service initialized handsets through carrier-sponsored efforts program those handsets with the code 123-456-7890 as the telephone number/mobile identification number to alert PSAPs that a 911 call is being made from a wireless phone that lacks call-back capability. Further, section 20.18(l)(2)(i) requires that all manufacturers of “911-only” handsets manufactured on or after October 1, 2002, program each handset with the same code.

3. The Reconsideration Petition notes a solution not raised in the record to address the lack of call-back capability. The proposed solution is based on a technical standard published jointly by the Telecommunications Industry Association (TIA) and ATIS. The standard suggests the use of a wireless handset's Electronic Serial Number (ESN) or International Mobile Station Equipment Identity (IMEI) to create a surrogate number: “911” plus the last seven digits of the ESN or IMEI expressed as a decimal number. According to the Reconsideration Petition, using this surrogate number provides easier identification of the specific phone used in placing a wireless 911 call. Moreover, the surrogate number allegedly permits (1) the PSAP to prevent the misuse of the 9-1-1 system due to repeated harassing calls made on non-initialized phones, and (2) the identification of legitimate emergency callers making multiple calls.

4. The Reconsideration Petition also asserts that ESIF has identified a problem that was not addressed in the record of this proceeding. According to ESIF, the number requirement, 123-456-7890, in the Commission's new rules also serves as a valid International Roaming MIN (Mobile Identification Number) (“IRM”) range. As a result, the potential impact of the 123-456-7890 code is to remove one million numbers the IRM assignment pool, when IRMs are a finite numbering resource where the first number must be a zero (0) or a one (1).

5. The Commission seeks comment on the issues raised by the Petition and Request. Pursuant to 47 CFR 1.1200(a), this proceeding is designated a “permit but disclose” proceedings and subject to § 1.1206. Ex parte presentations that are made will be allowed but must be disclosed in accordance with the requirements of 47 CFR 1.1206(b).

6. Pursuant to 47 CFR 1.415, 1.419, interested parties may file oppositions to the Request for Stay on or before August 2, 2002. Replies are due August 19, 2002.

7. Pursuant to § 1.429 of the Commission's rules, interested parties may file comments to the Petition for Reconsideration on or before August 2, 2002. Reply comments are due August 19, 2002.

8. Pleadings may be filed using the Commission's Electronic Comment Filing System (ECFS) or by filing paper copies. Comments filed through the ECFS can be sent as an electronic file via the Internet to <http://www.fcc.gov/e-file/ecfs.html>. Generally, only one copy of an electronic submission must be filed. In completing the transmittal screen, filing parties should include their full name, Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions for e-mail comments, parties should send an e-mail to ecfs@fcc.gov, and should include the following words in the body of the message, “get form <your e-mail address>.” A sample form and directions will be sent in reply. Parties who choose to file by paper must file an original and four copies of each filing. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although we continue to experience delays in receiving U.S. Postal Service mail). The Commission's contractor, Vistronix, Inc., will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building. Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. U.S. Postal Service first-class mail, Express Mail, and Priority Mail should be addressed to 445 12th Street, SW., Washington, DC 20554. All filings must be addressed to the Commission's Secretary, Office of the Secretary,

9. Federal Communications Commission. In addition, a diskette copy should be sent to 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 to qualexint@aol.com.

On December 7, 2001 (66 FR 63512), the Federal Register published a summary of the final rule in the above captioned proceeding. Instruction 5 of the rules amended § 25.208 by revising paragraph (c), removing paragraph (d), and redesignating paragraph (e) as paragraph (d) and paragraph (f) as paragraph (e). In redesignating paragraph (e) as paragraph (d), the instructions neglected to revise paragraph (d) of § 25.208(d). This document corrects § 25.208(d).

On page 63515, in the third column, instruction 5 is corrected to read as follows:

5. Section 25.208 is amended by removing paragraph (d), redesignating paragraphs (e) and (f) as paragraphs (d) and (e) and by revising paragraph (c) and newly designated paragraph (d) to read as follows:

We published a Final Rule document in the Federal Register of January 16, 2002, (67 FR 2136), extending the regulations on managing the integrity of hazardous liquid and carbon dioxide pipelines that affect high consequence areas to operators with less than 500 miles of regulated pipelines. In § 195.452(d)(2), the date after which prior assessments may qualify for use was incorrectly published as December 18, 2006. The correct date is February 15, 1997.

In FR Doc. 01-31655, published January 16, 2002, (67 FR 2136), make the following correction: On page 2144, correct the table in the second column by removing the date “December 18, 2006” and adding “February 15, 1997”, in its place.