This action is not subject to the provisions of Executive Order 12866 since it involves only internal Agency management. This action is not published for proposed rulemaking because it involves only internal Agency management and publication for notice and comment is not necessary.

The Catalog of Federal Domestic Assistance Program impacted by this action is 10.766, Community Facilities Loans and Grants.

These loans are subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. RHS conducts intergovernmental consultations for each loan in the manner delineated in 7 CFR, part 3015 subpart V.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. In accordance with this rule: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) except as expressively provided in the regulation, no retroactive effect will be given to this rule; and (3) administrative proceedings of the National Appeals Division (7 CFR part 11) must be exhausted before bringing suit in court challenging action taken under this rule.

The action has been reviewed in accordance with 7 CFR part 1940, subpart G, “Environmental Program.” The Agency has determined that this action does not constitute a major Federal action significantly affecting the quality of the human environment and, in accordance with the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq. , an Environmental Impact Statement is not required.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. chapters 17A and 25, established requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, RHS generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures to State, local, or tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. When such a statement is needed for a rule, section 205 of the UMRA generally requires RHS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

This rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612). The undersigned has determined and certified by signature of this document that this rule will not have a significant economic impact on a substantial number of small entities since this rulemaking action does not involve a new or expanded program.

It is the policy of this Department that rules relating to public property, loans, grants, benefits, or contracts shall comply with 5 U.S.C. 553, notwithstanding the exemption of that section with respect to such rules. This action is not published for proposed rulemaking because it involves only internal Agency management and publication for notice and comment is unnecessary.

The information collection and recordkeeping requirements contained in this regulation have been approved by the Office of Management and Budget (OMB) under the provisions of 44 U.S.C. chapter 35 and were assigned OMB control number 0575-0015 in accordance with the Paperwork Reduction Act of 1995. Under the Paperwork Reduction Act of 1955, no person is required to respond to a collection of information unless it displays a valid OMB control number. This final rule does not impose any new information or recordkeeping requirements.

The Agency has determined that internal administrative forms completed by Agency employees are not subject to Federal regulatory requirements when information is obtained from other OMB-approved forms. Removal of administrative processing requirements and administrative forms will improve our ability to modernize our documentation process used to determine project feasibility and eligibility for program funding. We are developing a customized project summary for each project with our automated system to replace Forms RD 1942-14, 1942-43, and 1942-45.

In an interim rule effective and published in the Federal Register on April 16, 2002 (67 FR 18466-18467, Docket No. 01-110-1), we amended the Texas (splenetic) fever in cattle regulations in 9 CFR part 72 by updating the incorporation by reference of the Texas Animal Health Commission regulations that contain the description of the areas in Texas quarantined because of ticks. The interim rule was necessary to update the incorporation by reference to reflect the effective date of the current Texas Animal Health Commission regulations that describe the quarantined area.

Comments on the interim rule were required to be received on or before June 17, 2002. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

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

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

Public Law 100-656, enacted on November 15, 1988, incorporated into the Small Business Act the previously existing regulation that recipients of Federal contracts set aside for small businesses or SBA 8(a) Program procurement must provide the product of a small business manufacturer or processor, if the recipient is other than the actual manufacturer or processor. This requirement is commonly referred to as the Nonmanufacturer Rule. The SBA regulations imposing this requirement are found at 13 CFR 121.906(b) and 121.1106(b). Section 303(h) of the law provides for waiver of this requirement by SBA for any “class of products” for which there are no small business manufacturers or processors in the Federal market. To be considered available to participate in the Federal market on these classes of products, a small business manufacturer must have submitted a proposal for a contract solicitation or received a contract from the Federal government within the last 24 months. The SBA defines “class of products” based on two coding systems. The first is the Office of Management and Budget North American Industry Classification System. The second is the Product and Service Code established by the Federal Procurement Data System.

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 special condition 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 CE190.” The postcard will be date stamped and returned to the commenter.

On February 11, 2002, CenTex Aerospace, Inc. applied for a supplemental type certificate for their Beech Model A36 airplane. The Beech Model A36 is powered by a Teledyne Continental Motors model IOF-550-B engine. This engine incorporates Full Authority Digital Electronic Controls.

Under the provisions of 14 CFR § 21.101, CenTex Aerospace, Inc. must show that the Beech Model A36 meets the applicable provisions of 14 CFR part 23, as amended by Amendments 23-1 through 23-53 thereto.

If the Administrator finds that the applicable airworthiness regulations ( i.e. , 14 CFR part 23) do not contain adequate or appropriate safety standards for the Beech Model A36 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Beech Model A36 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy pursuant to section 611 of Public Law 92-574, the “Noise Control Act of 1972.”

Special conditions, as appropriate, as defined in § 11.19, are issued in accordance with § 11.38, and become part of the type certification basis in accordance with § 21.101.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.

The Beech Model A36 will incorporate the following novel or unusual design features:

The CenTex Aerospace, Inc. Beech Model A36 airplane will use an engine that includes an electronic control system with full engine authority capability.

Many advanced electronic systems are prone to either upsets or damage, or both, at energy levels lower than analog systems. The increasing use of high power radio frequency emitters mandates requirements for improved high intensity radiated fields (HIRF) protection for electrical and electronic equipment. Since the electronic engine control system used on the CenTex Aerospace, Inc. Beech Model A36 will perform critical functions, provisions for protection from the effects of HIRF fields should be considered and, if necessary, incorporated into the airplane design data. The FAA policy contained in Notice 8110.71, dated April 2, 1998, establishes the HIRF energy levels that airplanes will be exposed to in service. The guidelines set forth in this Notice are the result of an Aircraft Certification Service review of existing policy on HIRF, in light of the ongoing work of the ARAC Electromagnetic Effects Harmonization Working Group (EEHWG). The EEHWG adopted a set of HIRF environment levels in November 1997 that were agreed upon by the FAA, JAA, and industry participants. As a result, the HIRF environments in this notice reflect the environment levels recommended by this working group. This notice states that a full authority digital engine control is an example of a system that should address the HIRF environments.

Even though the control system will be certificated as part of the engine, the installation of an engine with an electronic control system requires evaluation due to the possible effects on or by other airplane systems ( e.g. , radio interference with other airplane electronic systems, shared engine and airplane power sources). The regulatory requirements in 14 CFR part 23 for evaluating the installation of complex systems, including electronic systems, are contained in § 23.1309. However, when § 23.1309 was developed, the use of electronic control systems for engines was not envisioned; therefore, the § 23.1309 requirements were not applicable to systems certificated as part of the engine (reference § 23.1309(f)(1)). Also, electronic control systems often require inputs from airplane data and power sources and outputs to other airplane systems ( e.g. , automated cockpit powerplant controls such as mixture setting). Although the parts of the system that are not certificated with the engine could be evaluated using the criteria of § 23.1309, the integral nature of systems such as these makes it unfeasible to evaluate the airplane portion of the system without including the engine portion of the system. However, § 23.1309(f)(1) again prevents complete evaluation of the installed airplane system since evaluation of the engine system's effects is not required.

Therefore, special conditions are proposed for the CenTex Aerospace, Inc., Beech Model A36 to provide HIRF protection and to evaluate the installation of the electronic engine control system for compliance with the requirements of § 23.1309(a) through (e) at Amendment 23-46.

As discussed above, these special conditions are applicable to the Beech Model A36. Should CenTex Aerospace, Inc. apply at a later date for a change to the type certificate to include another model incorporating 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 Beech model A36 airplane. It is not a rule of general applicability, and it 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.

The FAA published a document on May 24, 2002 (67 FR 36502) that issued final special conditions. In the document under the Novel or Unusual Design Features section, a company by the name of “Carpenter Avionics Inc.” appears, and it should have read “Avidyne Corporation.” This document corrects that error.

Accordingly, on page 36503, in column 3, the preamble of the special conditions is corrected to remove the name “Carpenter Avionics Inc.” and to replace it with the name “Avidyne Corporation” in the Novel or Unusual Design Features section.

The FAA has determined that notice and opportunity for prior public comment hereon is unnecessary as the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance; however, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

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

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

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

On November 29, 1999, Cessna Aircraft Company, One Cessna Boulevard, Wichita, KS 67277, submitted an application for a new type certificate for the Cessna Model 680 Sovereign airplane. The proposed new model is a twin engine, medium size business jet. The significant airplane design features include an aluminum fuselage and wing. The significant systems features include a brand new, state-of-the-art integrated avionics/electronics and electrical systems suite. The avionics/electronics and electrical systems installed in this airplane have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.17, the Cessna Aircraft Company must show that the Model 680 Sovereign airplane meets the provisions of 14 CFR part 25, effective February 1, 1965, as amended by Amendments 25-1 through 25-98; 14 CFR part 34, effective September 10, 1990, as amended by any amendment in effect on the date of certification; 14 CFR part 36, effective December 1, 1969, as amended by Amendments 36-1 through any amendment in effect on the date of certification. Subsequent changes have been made to § 21.101 as part of Amendment 21-77, but those changes do not become effective until June 10, 2003.

If the Administrator finds that the applicable airworthiness regulations ( i.e. , part 25, as amended) do not contain adequate or appropriate safety standards for the Cessna Model 680 Sovereign airplane because of novel or unusual design features, special conditions are prescribed under the provisions of 14 CFR 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Cessna 680 Sovereign airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy pursuant to section 611 of Public Law 92-574, the “Noise Control Act of 1972.”

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

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of 14 CFR 21.101(a)(1), Amendment 21-60, effective September 16, 1991.

The Cessna Model 680 Sovereign airplane will incorporate brand new avionics/electronics and electrical systems that will perform critical functions. These systems may be vulnerable to HIRF external to the airplane.

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

To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Cessna Model 680 Sovereign airplane. These special conditions require that new avionics/electronics and electrical systems that perform critical functions be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

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

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

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

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

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

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

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

As discussed above, these special conditions are applicable to the Cessna Model 680 Sovereign airplane. Should Cessna Aircraft Company apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well under the provisions of 14 CFR § 21.101(a)(1), Amendment 21-60, effective September 16, 1991.

This action affects only certain design features on the Cessna Model 680 Sovereign 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 the special conditions for these airplanes has been subjected to the notice and comment procedure in several prior instances and has been derived without substantive change from those previously issued. Because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions immediately. 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.

The Mental Health Parity Act of 1996 (MHPA) was enacted on September 26, 1996 (Pub. L. 104-204, 110 Stat. 2944). MHPA amended the Employee Retirement Income Security Act of 1974 (ERISA) and the Public Health Service Act (PHS Act) to provide for parity in the application of annual and lifetime dollar limits on mental health benefits with dollar limits on medical/surgical benefits. Provisions implementing MHPA were later added to the Internal Revenue Code of 1986 (Code) under the Taxpayer Relief Act of 1997 (Pub. L. 105-34, 111 Stat. 1080).

The provisions of MHPA are set forth in Part 7 of Subtitle B of Title I of ERISA, Chapter 100 of Subtitle K of the Code, and Title XXVII of the PHS Act. 1 The Secretaries of Labor, the Treasury, and Health and Human Services share jurisdiction over the MHPA provisions. These provisions are substantially similar, except as follows:

• The MHPA provisions in ERISA generally apply to all group health plans other than governmental plans, church plans, and certain other plans. These provisions also apply to health insurance issuers that offer health insurance coverage in connection with such group health plans. Generally, the Secretary of Labor enforces the MHPA provisions in ERISA, except that no enforcement action may be taken by the Secretary against issuers. However, individuals may generally pursue actions against issuers under ERISA and, in some circumstances, under State law.

• The MHPA provisions in the Code generally apply to all group health plans other than governmental plans, but they do not apply to health insurance issuers. A taxpayer that fails to comply with these provisions may be subject to an excise tax under section 4980D of the Code.

• The MHPA provisions in the PHS Act generally apply to health insurance issuers that offer health insurance coverage in connection with group health plans and to certain State and local governmental plans. States, in the first instance, enforce the PHS Act with respect to issuers. Only if a State does not substantially enforce any provisions under its insurance laws will the Department of Health and Human Services enforce the provisions, through the imposition of civil money penalties. Moreover, no enforcement action may be taken by the Secretary of Health and Human Services against any group health plan except certain State and local governmental plans.

The MHPA provisions are set forth in section 712 of ERISA, section 9812 of the Code, and section 2705 of the PHS Act. MHPA applies to a group health plan (or health insurance coverage offered by issuers in connection with a group health plan) that provides both medical/surgical benefits and mental health benefits. MHPA's original text included a sunset provision specifying that MHPA's provisions would not apply to benefits for services furnished on or after September 30, 2001. On December 22, 1997 the Departments of Labor, the Treasury, and Health and Human Services issued interim final regulations under MHPA in the Federal Register (62 FR 66931). The interim final regulations included this statutory sunset date.

On January 10, 2002, President Bush signed H.R. 3061 (Pub. L. 107-116, 115 Stat. 2177), the 2002 Appropriations Act for the Departments of Labor, Health and Human Services, and Education. 2 This legislation extends MHPA's original sunset date under ERISA, the Code, and the PHS Act, so that MHPA's provisions will not apply to benefits for services furnished on or after December 31, 2002. Like MHPA, the amendment to MHPA applies to a group health plan (or health insurance coverage offered by issuers in connection with a group health plan) that provides both medical/surgical benefits and mental health benefits. 3 As a result of the statutory amendment, and to assist employers, plan sponsors, health insurance issuers, and workers, the Department of Labor has developed this amendment of the interim final regulations, in consultation with the Departments of the Treasury and Health and Human Services, conforming the regulatory sunset date to the new statutory sunset date.

On March 9, 2002, President Bush signed H.R. 3090, the Job Creation and Worker Assistance Act of 2002 (Pub. L. 107-147, 116 Stat. 21), that included an amendment to section 9812 of the Code (the mental health parity provisions). This legislation further extends MHPA's original sunset date under the Code to December 31, 2003. The Joint Committee on Taxation's technical explanation of H.R. 3090 (JCT Report) states that the January 10th amendment to MHPA restored the excise tax retroactively to September 30, 2001. Under H.R. 3090, the excise tax provision of MHPA is amended to apply to benefits for such services furnished on or after January 10, 2002 and before January 1, 2004. MHPA's parallel provisions contained in ERISA and the PHS Act were not amended regarding either the period between September 30, 2001 and January 10, 2002 or the extension of the sunset date beyond December 31, 2002. As indicated by the JCT Report, H.R. 3061 restored the MHPA provisions retroactively to September 30, 2001. Therefore, the Department is making the effective date of this interim final amendment to the regulations effective September 30, 2001. The Department is also making conforming changes extending the duration of the increased cost exemption to be consistent with the new sunset date. Since the statute is retroactive, making the regulation retroactive limits confusion and disruption to employers, plan sponsors, and workers.

Since the extension of this sunset date is not discretionary, this amendment to the MHPA regulations is promulgated on an interim final basis pursuant to Section 734 of ERISA. This interim final amendment is also promulgated pursuant to Section 553(d)(3) of the Administrative Procedure Act, allowing for regulations to become effective immediately for good cause.

Under Executive Order 12866, the Department must determine whether a regulatory action is “significant” and therefore subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Under section 3(f), the order defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also referred to as “economically significant”); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of the Executive Order, it has been determined that this action is not a “significant regulatory action” within the meaning of the Executive Order. This action is an amendment to the 1997 interim final regulations and merely extends the regulatory sunset date to conform to the new statutory sunset date added by H.R. 3061.

The information collection provisions of MHPA incorporated in the Department's interim final rules are currently approved under OMB control numbers 1210-0105 (Notice to Participants and Beneficiaries and Federal Government of Electing One Percent Increased Cost Exemption), and 1210-0106 (Calculation and Disclosure of Documentation of Eligibility for Exemption). These information collection requests are approved through November 30, 2004 and October 31, 2004, respectively. Because no substantive or material change is made to the approved information collection provisions in connection with this interim final amendment, no submission for continuing OMB approval is required or made at this time.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) (RFA) imposes certain requirements with respect to federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 et seq. ). Because this amendment to the 1997 interim final regulations is being published on an interim final basis, without prior notice and a period for comment, the Regulatory Flexibility Act does not apply.

For purposes of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) (UMRA), as well as Executive Order 12875, this interim final amendment does not include any Federal mandate that may result in expenditures by State, local, or tribal governments, and does not include mandates that may impose an annual expenditure of $100 million or more on the private sector.

This interim final amendment is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ) (SBREFA), and has been transmitted to Congress and the Comptroller General for review. This amendment to the 1997 interim final regulations is not a major rule, as that term is defined by 5 U.S.C. 804.

Executive Order 13132 (August 4, 1999) outlines fundamental principles of federalism and requires the adherence to specific criteria by federal agencies in the process of their formulation and implementation of policies that have substantial direct effects on the States, the relationship between the States, the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. This interim final amendment does not have federalism implications as it only conforms the regulatory sunset date to the new statutory sunset date added by H.R. 3061.

On September 30, 2002, FMSHRC will move its Headquarters office from 1730 K Street, NW, 6th Floor, Washington, DC 20006 to 601 New Jersey Avenue, NW, Suite 9500, Washington, DC 20001. On that same date, FMSHRC will move its Office of Administrative Law Judges from Skyline Towers No. 2, Tenth Floor, 5203 Leesburg Pike, Falls Church, Virginia 22041 to 601 New Jersey Avenue, NW, Suite 9500, Washington, DC 20001. The Office of Administrative Law Judges presently located at 1244 Speer Boulevard, Suite 280, Denver, Colorado 80204, will remain at that location.

Because this amendment deals with agency management and procedures, the notice and comment provisions of the Administrative Procedure Act do not apply pursuant to 5 U.S.C. 553(a)(2) and (b)(3)(A).

Good cause exists to dispense with the usual 30-day delay in the effective date because the amendments are of a minor and administrative nature dealing with only a change in address.

This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1955 (44 U.S.C. 3501 et seq. ).

This final rule is not a “regulatory action” under section 3 of Executive Order 12866, and has not been reviewed by the Office of Management and Budget. The rule is an administrative action that changes the address of a Federal agency. Because the rule is limited to agency organization, management and personnel, it falls within the exclusion set forth in section 3(d)(3) of the Executive Order.

In promulgating this rule, FMSHRC has adhered to the regulatory philosophy and applicable principles of regulation set forth in section 1 of the Executive Order.

For purposes of the Unfunded Mandates Reform Act of 1995, this rule does not include any Federal mandate that may result in increased expenditures by State, local or tribal governments, or by the private sector.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and 553(d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this rule effective less than 30 days after publication in the Federal Register . The event will be held on Saturday, October 5, 2002. There is not sufficient time to allow for a notice and comment period, prior to the event. Because of the danger posed by other vessels operating near rowing shells competing within a confined area, special local regulations are necessary to provide for the safety of event participants, spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event. In addition, advance notifications will be made via the Local Notice to Mariners, marine information broadcasts, and area newspapers.

On October 5, 2002, Riverfest Celebrations, Inc. will sponsor the “Head of the Cape Fear Regatta” on the waters of the Cape Fear River, Wilmington, North Carolina. The event will consist of rowing shells racing in heats of 30 against the clock along a 3-mile section of the Cape Fear River. To provide for the safety of spectators and other transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the event.

The Coast Guard is establishing temporary special local regulations on specified waters of the Cape Fear River. The regulated area includes all waters of the Cape Fear River from the Cape Fear Memorial Bridge upriver to the Seaboard Coast Line Railroad Bridge at Navassa Turning Basin. The temporary special local regulations will be in effect from 7:30 a.m. to 5:30 p.m. on October 5, 2002. The effect will be to restrict general navigation in the regulated area during the event. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area. The Patrol Commander will allow non-participating vessels to transit the regulated area at slow speed between heats when safe to do so. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

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).

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

Under the Regulatory Flexibility Act (5 U.S.C. 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.

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

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the 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, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule 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. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

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

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 and 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 have considered the environmental impact of this rule and concluded that, under figure 2-1, paragraphs (34)(h) and (35)(a) of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade permit are specifically excluded from further analysis and documentation under those sections. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.

The Walnut Grove Highway drawbridge, mile 26.7, over the Sacramento River at Walnut Grove, CA, is owned and operated by Sacramento County. It is a double leaf bascule drawbridge providing 21 feet vertical clearance above mean high water in the closed-to-navigation position. Vessels that can pass under the bridge without an opening may do so at all times. Presently, as set out in 33 CFR 117.189, the draw is required to open on signal from 9 a.m. to 5 p.m., November 1 through April 30; and 6 a.m. to 10 p.m., May 1 through October 31; and all other times if at least 4 hours advance notice is given. At the bridge location, the Sacramento River is navigated by commercial and recreational vessels requiring several daily openings of the drawspan.

During the repair period, 1 hour advance notice will be required before opening and the bridge will perform single leaf operation of the drawspan for vessel traffic from 8 a.m. to 5 p.m. daily, October 28 through November 1, 2002. Single leaf openings will be provided for emergency operation upon 15 minute advance notice. Sacramento County requested a temporary deviation from the normal operation of the drawbridge in order to allow for repairs. This deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation from the normal operating regulations in 33 CFR 117.5 is authorized in accordance with the provisions of 33 CFR 117.35.

The bridge owner, New York City Department of Transportation, requested a temporary deviation from the drawbridge operating regulations to facilitate necessary maintenance, to install paint containment, scaffold, and implement painting operations, at the bridge. The installation of the paint containment and scaffold, necessary to conduct painting operations, require the bridge to remain in the closed position.

Under this temporary deviation the 103 Street (Wards Island) Bridge may remain closed to vessel traffic from 8 a.m. on September 23, 2002 through 5 p.m. on November 20, 2002.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

On June 4, 2002, we published a notice of proposed rulemaking (NPRM) entitled “Safety Zones; Ponce Bay, Tallaboa Bay, Guayanilla Bay, Puerto Rico, and Limetree Bay, St. Croix U.S.V.I.” in the Federal Register (67 FR 38451). We received no letters commenting on the proposed rule. No public hearing was requested and none was held.

These rules are needed to provide for the safety of life on navigable waters from the hazards associated with Liquified Hazardous Gas (LHG) carriers. The safety zones are needed because of the significant risks LHG ships present to public safety due to their size, draft, and volatile cargoes. We anticipate periodic arrivals of vessels carrying LHG in Ponce, Tallaboa and Guayanilla Bays, Puerto Rico and Limetree Bay, St. Croix, U.S. Virgin Islands. This rule will keep vessel traffic at least 100 yards away from LHG vessels thereby decreasing the risk of a collision, allision, or grounding.

This rule establishes a 100-yard safety zone in the waters of the Caribbean Sea surrounding all LHG vessels with product aboard while transiting on approach to or departing from the following Ports, north of the latitudes indicated. Port of Ponce, Puerto Rico north of Latitude 17°56.00' N. Ports of Tallaboa and Guayanilla, Puerto Rico north of Latitude 17°57.00' N. Port of Limetree Bay, St. Croix, U.S. Virgin Islands north of 17°39.00' N. All coordinates are NAD 83. These safety zones remain in affect until the LHG vessel is safely moored. The Marine Safety Office San Juan will notify the maritime community of periods during which these safety zones will be in effect by providing advance notice of scheduled arrivals and departures on LHG carriers via a broadcast notice to mariners on VHF Marine Band Radio, Channel 16 (156.8 MHz).

No comments were received on the proposed rule.

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, l979). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary due to the relatively infrequent arrival of LHG carriers, the limited size of the safety zone, and the relatively sparse nature of other commercial traffic in Ponce, Tallaboa, Guayanilla, and Limetree Bays.

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

This rule may affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit a portion of Ponce, Tallaboa, Guayanilla, and Limetree Bays while a LHG vessel transits and docks at a facility. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities because of the relative infrequent arrivals of LHG carriers, the limited size of the safety zone, and the relatively sparse nature of other commercial traffic in Ponce, Tallaboa, Guayanilla, and Limetree Bays.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Lieutenant Chip Lopez at (787) 706-2444 for assistance in understanding this rulemaking. We also have a point of contact for commenting on actions by employees of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small businesses. 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).

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

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

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 safety that may disproportionately affect children.

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

For the reasons discussed in the Preamble, the Coast Guard amends 33 CFR part 165 as follows:

VA regulations at 38 CFR 3.700(a)(3) currently state that there is no prohibition against payment of compensation if a veteran received nondisability severance pay from the military.

In a precedent opinion (VAOPGCPREC 12-96), VA's General Counsel held that the portion of 38 CFR 3.700(a)(3) which states that there is no prohibition against payment of compensation to a veteran who received nondisability severance pay is of no effect because it is inconsistent with 10 U.S.C. 1174(h)(2), which as added in 1980 by Public Law 96-513, section 109(c), 94 Stat. 2835, 2870 (1980), requires, effective September 15, 1981, recoupment of nondisability severance pay from VA compensation. Therefore, VA is amending 38 CFR 3.700(a)(3) to conform to the governing statute.

Public Law 104-201 amended 10 U.S.C. 1174(h)(2) to exclude Federal income tax withheld from payments of separation pay, severance pay and readjustment pay made after September 30, 1996, from VA recoupment. VA is amending 38 CFR 3.700(a)(2)(iii), (a)(3), and (a)(5)(i) to conform to this governing statute. In addition, VA is making nonsubstantive changes to 38 CFR 3.700 for purposes of clarity.

Except with respect to the amendment relating to income tax, this rule applies to disability compensation paid after September 14, 1981; the amendment relating to income tax applies only to payment of separation pay, special separation benefits under 10 U.S.C. 1174a, severance pay, and readjustment pay made after September 30, 1996.

While this document updates VA regulations concerning statutes enacted in 1981 and 1996, VA procedures have adhered to these statutes since their enactment. This document brings VA regulations into conformance with VA practice and will not create overpayments in any existing claims.

Changes made by this final rule merely reflect the statutory requirements in title 10, U.S.C. or are nonsubstantive changes made for purposes of clarity. Accordingly, there is a basis for dispensing with prior notice and comment and delayed effective date provisions of 5 U.S.C. 552 and 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).

This document has been reviewed by the Office of Management and Budget under Executive Order 12866.

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, 5 U.S.C. 601-612. This amendment would not directly affect any small entities. Only individuals 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 analyses requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance program number is 64.109.

Transportation conformity is required under section 176(c) of the Clean Air Act (42 U.S.C. 7506(c) to ensure that federally supported highway and transit project activities are consistent with (“conform to”) the purpose of a state air quality implementation plan. EPA's transportation conformity rule established the criteria and procedures for determining whether transportation activities conform to the state air quality plan.

EPA first published the transportation conformity rule on November 24, 1993 (58 FR 62188), and made subsequent revisions to the rule in 1995 (60 FR 40098, August 7, 1995, and 60 FR 57179, November 14, 1995). On August 15, 1997, however, EPA published a comprehensive set of amendments that clarified and streamlined language from the 1993 transportation conformity rule and 1995 amendments (62 FR 43780). Since the publication of the 1997 rule, EPA has made two additional revisions to the conformity rule in 2000 and 2002 ( 65 FR 18911, April 10, 2000, and 67 FR 50808, August 6, 2002).

The August 2002 amendment to the conformity rule addressed, in part, the decision made on March 2, 1999, by the U.S. Court of Appeals for the District of Columbia Court that affected several provisions of the 1997 rulemaking ( Environmental Defense Fund v. EPA, et al. , 167 F. 3d 641, D.C. Cir 1999). Specifically, the August amendment addressed the impact of this Court decision on one provision of the conformity rule, Section 93.104 (e). With this rule change, conformity must now be determined within eighteen months of the effective date of the Federal Register notice announcing EPA's finding that the motor vehicle emission budgets in an initial SIP submission are adequate rather than within eighteen months of initial SIP submission.

We made this minor change to the conformity rule to respond to the Court decision that EPA must find motor vehicle emissions budgets in submitted SIPs adequate before they can be used in a conformity determination. The August 2002, rulemaking also changes the starting point for eighteen month clocks that are currently running for areas with initial SIP submissions, so that these areas are given the full eighteen months after EPA's adequacy finding to determine conformity to their SIPs. In other words, in areas where a SIP has been submitted and EPA is currently reviewing it for adequacy, the eighteen-month clock required by section 93.104(e) (2) will now not start until the effective date of our adequacy finding. For areas that have submitted initial SIPs that EPA has already found adequate and to which conformity has not yet been determined, the August rule restarts the eighteen-month clock from the effective date of EPA's positive adequacy finding. For more information on the eighteen-month conformity requirement for initial SIP submissions see the August 6, 2002 final rule (67 FR 50808).

Section 51.390 (b) of the conformity rule specifies that after EPA approves a conformity SIP revision, the federal rule no longer governs conformity determinations with respect to the provisions covered by the state rule. Therefore, areas that have approved SIPs governing eighteen-month triggers ( i.e. , SIPs that include 93.104(e)(a) from the 1997 transportation conformity rule), the actions of the August 6, 2002 rule will normally only be effective when EPA approves a conformity SIP revision that includes the amendment to the state rules to align the eighteen-month clock for initial SIP submissions with EPA's adequacy provisions. In the case of Atlanta, EPA has approved conformity SIP that included section 93.104(e)(2) from the 1997 version of the transportation conformity rule. However, EPA believes that its initial approval of Atlanta's SIP was in error. Specifically, EPA should not have approved section 105(e) of the State Interagency Transportation Conformity Memorandum of Agreement (MOA) since this provision mirrors section 93.104(e)(2) that was indirectly affected by the March 2, 1999 court decisions.

Therefore, in today's action, EPA is correcting its earlier approval of the Atlanta, Georgia transportation conformity SIP to remove approval of section 105(e) of the Interagency Transportation Conformity MOA. EPA believes that its approval of that provision was in error, because it was made after the March 2, 1999, court ruling that conformity could not be shown to the motor vehicle emissions budgets in submitted SIPs until EPA finds such submitted budgets adequate for transportation conformity purposes. Since section 105(e) would require a determination of conformity within eighteen-months of submittal of an initial SIP, even if EPA had not found the budget to be adequate, EPA concludes that it should not have approved that section of the Atlanta SIP.

Therefore, pursuant to section 110(k)(6) of the Clean Air Act, EPA is now correcting its approval of the Atlanta SIP to remove its approval of section 105(e). In the absence of EPA approval of this provision, the state of Georgia will revert back to reliance of the Federal transportation conformity rule and its requirement for the eighteen-month conformity requirement for initial SIPs. That is, the eighteen-month conformity requirement will now be triggered in Atlanta only from the effective data of EPA's adequacy finding for such initial SIPs.

The EPA is publishing this rule without a prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments are filed. This rule will be effective November 26, 2002, without further notice unless the Agency receives adverse comments by October 28, 2002.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on November 26, 2002, and no further action will be taken on the proposed rule.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Effect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely corrects our action that approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule corrects our action that approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely corrects our action that approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and will not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

This section is organized as follows:

Throughout this document “we” “us” and “our” means EPA.

We are granting approval of the Louisiana Department of Environmental Quality (LDEQ) ERC banking regulation as a component of the Louisiana SIP. The rule is promulgated by the State at LAC 33:III, Chapter 6 (Regulations on Control of Emissions Through the Use of Emission Reduction Credit Banking), as published in the Louisiana Register on February 20, 2002. The Governor of Louisiana submitted this rule to the EPA as a SIP revision on March 4, 2002.

Our approval of the revised ERC bank rule was necessary to reflect the rescission of the contingency measures' enforceable process contained in section 621 of the rule, to incorporate the “Surplus When Used” provision in accordance with the Act and our Administrator's Order of December 22, 2000, to remove the requirement that netting reductions for nonattainment new source review (NNSR) purposes meet the surplus requirement of the emissions bank and to remove section 611 regarding mobile sources emission reductions, which we had not previously approved as part of the SIP. In addition, the revised rule removed section 623, which covered the withdrawal, use and transfer of ERCs, and section 625, which covered the application and processing fees. Our approval of the revised rule, including the removal of these sections, does not constitute a relaxation of the SIP, since any and all relevant portions of these sections have been incorporated into the revised rule.

We approved the previous LDEQ Chapter 6 banking rule on July 2, 1999. That SIP approval did not include section 611, Mobile Source Emission Reductions, which the State had promulgated in August 1994, but did include sections 621, 623 and 625. Section 623 covered the withdrawal, use and transfer of ERCs. Section 625 covered the application and processing fees. We are granting approval of the LDEQ revised Chapter 6 bank rule to reflect the removal of sections 611, 621, 623 and 625.

The purpose of the revised rule is to establish the means of enabling stationary sources to identify and preserve or acquire emission reductions for New Source Review offsets. This purpose provides flexibility to stationary sources when they undergo NNSR, allowing sources in need of emissions offsets to identify another stationary source that may have surplus emission reductions available for purchase as NNSR offsets. Although Section 601 states that the purpose of the rule is to “identify and preserve” emission reductions for NNSR offsets, the revised rule does not itself provide a mechanism for “preserving” emission reductions until the permitting stage. That is, under LAC 33:III.617(C)(2), emission reductions can only be preserved after they are identified in the ERC certificate and LDEQ determines during the permit review process that they are “Surplus When Used.”

Section 553(d) of the Administrative Procedure Act generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register . If, however, an Agency identifies a good cause, section 553(d)(3) allows a rule to take effect earlier, provided that the Agency publishes its reasoning in the final rule. EPA is making this action effective immediately because this rule is related to the Baton Rouge 1-hour ozone Attainment Plan and Transport State Implementation Plan, on which the EPA intends to take imminent action (see 67 FR 50391, August 2, 2002). In conjunction with its August 2, 2002, proposed approval of the attainment demonstration, EPA proposed to extend the ozone attainment date for the Baton Rouge area to November 15, 2005, while retaining the area's current classification as a serious ozone nonattainment area and to withdraw EPA's June 24, 2002, rulemaking determining nonattainment and reclassification of the BR area (67 FR 42687). The effective date of EPA's June 24, 2002, nonattainment determination and reclassification is imminent. Furthermore, making this action effective immediately does not impose any additional requirements, because the underlying regulations are already effective under state law.

In spite of the fact that the revised rule is named an Emission Reduction Credit Banking regulation, it does not establish an ERC bank, and we therefore did not propose approval of the rule as an ERC bank. The program established by the revised rule merely functions as a bulletin board to facilitate stationary source communications and offset purchases before certification and use of ERCs in an NNSR permit application. Similarly, the program established by the revised Chapter 6 rule is not itself a market-based program for achieving air quality improvements, and is therefore not an EIP as defined by the EPA. Instead, the program may be used to reduce the administrative burden experienced by stationary sources obtaining emission reductions as a part of New Source Review permitting. Accordingly, we proposed approval of the revised Chapter 6 rule with the understanding that the program it establishes will be used in conjunction with the revised Chapter 5 NNSR rule to facilitate stationary source communications and offset purchases before certification and use of an ERC in an NNSR permit application.

An emissions banking rule that functions merely to facilitate communication between stationary sources is not within the scope of the guidance document “Improving Air Quality with Economic Incentive Programs,” EPA-452/R-01-011 (EPA Office of Air and Radiation, January 2001) (the EIP Guidance). We therefore did not review the revised rule for consistency with the EIP Guidance.

We proposed approval of the rule as meeting the requirements for SIP approval under Title I Part D and section 110 of the Act.

The Steering Committee of the Baton Rouge Ozone Task Force, the Leadership Team of the Baton Rouge Ozone Task Force, the Louisiana Chemical Association and the Louisiana Mid-Continent Oil and Gas Association comments.

Comment: Each of these parties commented by providing a statement of support for our proposed approval of the LDEQ revised ERC regulation.

Response: We have considered these statements of support in making our final determination.

Comment: Louisiana Generating LLC (LaGen) commented that LDEQ's proposed Attainment Plan/Transport SIP revisions contain a proposed Control Strategy Element, Section 4.2.1 Permitting NO X Sources, that could result in the imposition of the equivalent of the nonattainment rules in an attainment area without authority of law. LaGen stated that the revised LDEQ bank regulation is not approvable to the extent that any of the provisions of the regulation could be implemented to support requiring offsets of new facilities or major modifications in attainment parishes.

Response: The stated purpose of the LDEQ ERC revised rule in section 601 is to establish the means of enabling stationary sources to identify and preserve or acquire emission reductions for NSR offsets. As noted above, the program established by the revised rule does not function as an ERC banking or trading program, but merely as a bulletin board to facilitate stationary source communications and offset purchases before certification and use of ERCs in an NNSR permit application. The revised rule does not contain any provisions that could be implemented to support requiring offsets of new facilities or major modifications in attainment parishes. We therefore do not find in this comment any basis for disapproval of the proposed ERC bank rule.

Comment: LDEQ strongly supported our proposed approval, but requested several corrections and clarifications. One comment stated that our proposed approval notice at 67 FR 48086 indicated that LDEQ defined the term “Surplus Emission Reductions” whereas the rule at LAC 33:III.605 defines the term “Surplus” but not “Surplus Emission Reductions'.

Response: We have considered these statements of support in making our final determination.

The LDEQ comment regarding “Surplus Emission Reductions” is correct. The referenced sentence in our proposed approval notice should have read: “'Surplus” emission reductions are defined in LAC 33:III.605 as emission reductions voluntarily created for an emissions unit; not required by any local, state or federal law, regulation, order, or requirement; and in excess of reductions used to demonstrate attainment of federal and state ambient air quality standards.”

Comment: The second LDEQ comment indicated the appearance of missing text at 67 FR 48086.

Response: LDEQ correctly noted a typographical error in our proposed approval notice, although the error consisted of extra text (the words “the voluntary reduction”) rather than missing text. The referenced sentence in our proposed approval notice should have read: “Emissions reductions below these “baseline emissions” are considered surplus, and under the rule are calculated by subtracting future allowable emissions after the reductions from the baseline emissions.”

Comment: The third LDEQ comment requested clarification that the “surplus” determination is made at the time a permit application that relies upon the reductions as offsets is deemed administratively complete. Our proposed approval notice at 67 FR 48088 indicated that it was at the time of the State's evaluation of the permit application.

Response: We agree with LDEQ that a “surplus” determination is made at the time a permit is deemed administratively complete, as is apparent from the definition of “surplus” in Section 605 of the revised Louisiana rule, and from Section 617(a), which says that LDEQ will review an application for ERCs when a request is submitted to use the ERCs as offsets. Thus, the State's verification that the ERCs are surplus must be conducted when they are to be used, not when they are acquired (or submitted for certification or purchased). We agree with LDEQ that the most appropriate time for LDEQ to make its review and determination as to “surplus” is after the application is deemed administratively complete. (This timing is consistent with EPA policy regarding determinations for netting purposes.)

Comment: LDEQ commented that the State has recently promulgated and revised the NO X control regulation in Chapter 22. Our proposed approval notice stated that the State has recently revised the NO X control regulation in Chapter 22.

Response: We agree with LDEQ that the State has recently promulgated and revised the NO X control regulation.

Tulane submitted the comments by fax on August 26, 2002. The EPA is under no obligation to extend the comment period or to accept late comments. We decided to accept comments which were received by our office by close-of-business on August 26, 2002. This time frame corresponds to the estimated travel time for first class mail for a letter mailed and postmarked on the last day of the comment period, August 22, 2002.

Comment: The compliance date for NO X sources is May 1, 2005. Voluntary NO X reductions before this date could be deemed surplus and therefore eligible for use as emission offsets, which could allow facilities to offset new VOC emissions by early RACT implementation.

Response: The EPA disagrees with the commenter's interpretation that facilities which elect to implement RACT before the compliance date required by the rule, May 1, 2005, would generate reductions eligible for use as emission offsets.

Louisiana promulgated its revised NO X rules on February 20, 2002 (Louisiana Register, Vol. 28, No. 2). On February 27, 2002, the State submitted to EPA the revised NO X rules for the Baton Rouge area and its Region of Influence. The revised NO X rule requires certain affected categories of NO X -generating facilities to achieve RACT “as expeditiously as possible, but no later than May 1, 2005.” This date takes into consideration the time affected categories of NO X -generating facilities may need to procure, calibrate and implement RACT. On July 23, 2002, the EPA proposed approval of the SIP revisions to regulate emissions of NO X to meet requirements of the CAA (67 FR 48095). Section 173(c)(2) of the Act states that reductions otherwise required by the Act are not creditable as offsets. Although the rule permits affected categories of NO X -generating facilities to achieve compliance with NO X RACT no later than May 1, 2005, the rule became effective when promulgated. Therefore, facilities achieving NO X RACT compliance before May 1, 2005, are creating emission reductions as required by law. Therefore, such facilities will not obtain ERCs and cannot offset VOC emissions by early RACT implementation. Furthermore, emissions decreased by a voluntary action must be permanent in order to meet the surplus ERC criteria. Because the rule provides for compliance no later than May 1, 2005, reductions made before that date could not be considered permanent, and therefore could not be surplus.

For the above reasons, the comment does not indicate that any change to the rule is required.

Comment: Tulane states, as an example of a “segmented approach” by which they charge that EPA has avoided addressing how various state rules will operate together, that EPA acknowledged at 67 FR 48097 that Louisiana will need to develop a two-balance system for tracking NO X reductions, but deferred analysis of that issue to a “separate Federal Register document” that has yet to be issued.

Response: We disagree, both as to the general proposition that a “segmented approach” allowed the EPA to avoid issues, and as to the specific charge that EPA failed to present the promised analysis of the two-balance NO X reduction system.

We first note that both our proposed approval of the revised Chapter 6 rule and our proposed approval of the revised Section 504 rule (NNSR) addressed the general topic: “How Does the State's NSR Regulation in Chapter 5 Interact With the NO X Control Regulation in Chapter 22 and the Revised Banking Regulation in Chapter 6.”

Regarding the “deferred analysis” comment, the full sentence from which the above quotation was taken reads as follows: “We will be proposing action on Louisiana's ERC accounting in a separate Federal Register document.” That document was our proposed approval notice of the LDEQ revised ERC rule, which contained substantial discussion of the workings of the two-balance ERC system. See 67 FR 48087-48089. In addition, we requested in our proposed approval of the Chapter 5 NNSR rule “that in response to comments on EPA's proposed approval of the Chapter 5 and Chapter 6 rules, the State affirm and detail the procedures for the determination of NO X surplus ERCs resulting from the split emission limitations for the NO X RACT rule in Chapter 22”. 67 FR 48089. Additional discussion of this issue appears later in this section.

Comment: VOC increases from the Interpollutant Trading and NO X rules will have a disproportionate impact on minority communities, contrary to EIP Guidance, especially sections 16.2 and 16.9.

Response: The purpose of the revised ERC rule is to establish the means of enabling stationary sources to identify and preserve or acquire emission reductions for New Source Review offsets. Since the rule does not by itself directly reduce emissions or improve air quality, and is instead intended solely to enable stationary sources to identify and acquire NO X and VOC offsets for NNSR purposes, the rule was reviewed as a component of the SIP related to the NNSR offsets rule, not as an Economic Incentive Program. Thus, the EIP Guidance is not applicable to the revised ERC rule.

The revised rule does not contain any reference to an inter-precursor trading (that is, the trading of emission reductions of one pollutant's precursors for emission reductions of a different precursor for that pollutant) program. The purpose of the rule does not include inter-precursor, or for that matter, any emissions trading. The new source permitting regulation in Chapter 5, on the other hand, refers to what we consider inter-precursor trading. Under the revised Chapter 5 procedure, the State's verification that the ERCs are surplus must be conducted when they are to be used, not when they are acquired (or submitted for certification or purchased). Thus, inter-precursor trades are appropriately reviewed, evaluated and verified under the NSR program at the time of use. The comment is therefore not relevant to our approval of the proposed ERC bank rule. Further discussion of this issue will appear in our final rule regarding the revised NNSR rule, to be published in a separate Federal Register document.

Comment: The ERC bank is broken, is awaiting audit, and is not capable of tracking the expanded and more complicated emission offsets proposed in Louisiana's NO X and NSR rules. EPA should not approve any banking rule until the concerns raised in the public petition for an audit of the bank are addressed.

Response: We disagree that the program established by the revised ERC rule is broken. As stated earlier, the purpose of the LDEQ ERC revised rule is to establish the means of enabling stationary sources to identify and “preserve” or acquire emission reductions, the acceptability of which is later determined by the LDEQ, in the permitting process for NSR offsets. In spite of the fact that the revised rule is named an Emission Reduction Credit Banking regulation, the State did not adopt, nor did we propose to approve, the revised rule to function as an ERC bank or trading program. Rather, the revised rule merely provides a bulletin board to facilitate stationary source communications and offset purchases before potential certification and potential use in an NSR/NNSR permit application. The so-called “bank” in the revised rule will not itself provide ERCs that may be used for NSR/NNSR trading. The State makes a case-by-case determination in each individual permit application process about the validity of the ERCs relied upon in an application by a source owner/operator.

The revised ERC bank rule removes the necessity that ERCs be tracked to ensure that the bank contains sufficient ERCs for attainment demonstration contingency purposes. Our action approves a revision that is simplifying the function of the bank, not complicating it as indicated by the comment.

Comment: The deletion in the proposed ERC rule of language clearly disqualifying emissions reductions taken pursuant to a compliance order or consent decree from use as emissions offsets opens the door to illegal offsetting. Section 173(c)(2) prohibits the banking of credits for any emission reductions otherwise required by the Act.

Response: We disagree that the definitions of “surplus” and “enforceable” in the revised ERC rule open the door to illegal offsetting. As stated above, “surplus” emission reductions are defined in LAC 33:III.605 as, among other things, emission reductions not required by any local, state or federal law, regulation, order, or requirement. Compliance orders and consent decrees are orders as well as requirements of the Act, and emission reductions required under such an order or decree cannot be classified as surplus.

Comment: By eliminating the requirement that emission reductions be creditable under the definition of netting, Louisiana's proposed ERC rule violates federal law and must not be approved. Netting is a form of emission offsetting. LDEQ is now proposing to allow netting of emission reductions that do not qualify as ERCs, in violation of EPA policy and the Act. The definition of netting in the ERC rule violates section 173(c) of the Act and therefore LDEQ must not adopt the proposed rule as written.

Response: We disagree that netting is a form of emission offsetting. The term netting is derived from the NSR definition of “net emission increase” at 40 CFR 51.165 and 40 CFR 52.21. The net emission increase due to a specific project is the project emission increases plus any creditable, contemporary emission increases and decreases at the stationary source. Creditable in this sense refers among other things to the emissions not having been relied upon in the issuance of a major NSR permit during the contemporaneous period, as detailed at 40 CFR 51.165. The contemporaneous period in Louisiana has been defined as five years. Netting is the summation of the creditable contemporaneous emission increases and decreases at the facility. If the project emission increase exceeds the major modification threshold but the creditable, contemporaneous emission decreases are large enough, the net emission increase may be less than the major modification threshold. In this instance, the source would be said to “net out” of major source NSR review.

Section 173(c) of the Act refers to emission offsets required for emission increases resulting from major modifications and major new sources. It applies to major emission increases that result after the netting has been performed in the determination of the net emission increase. By previously requiring that all creditable, contemporaneous emission decreases be surplus ERCs from the bank, the LDEQ requirement for netting was more stringent than the federal requirement. By removing the surplus ERC requirement from the netting determination, the LDEQ NSR netting requirement is now equivalent to the federal requirement in 40 CFR 51.165 and 40 CFR 52.21.

Comment: Section 603(A) of the revised ERC rule apparently allows for trading of ERCs between five attainment parishes and five parishes in the Baton Rouge nonattainment area, in violation of section 173(c)(1) of the Act. If it is LDEQ's intent to allow such trading, it should rescind the rule immediately as contrary to federal law. If it is not LDEQ's intent to allow such trading, it should clearly so state within the regulation.

Response: We agree that section 173(c)(1) of the CAA does not permit trading of offsets between attainment areas and nonattainment areas. We disagree that Section 603(A) of the revised ERC rule permits such trading. Instead, Section 603(A) specifically provides that “[o]ther sources located in EPA-designated ozone attainment areas may not participate in the emissions banking program.” If the commenter is specifically concerned about the reference in Section 603(A) to Calcasieu Parish, which states that “[m]inor stationary sources located in ozone nonattainment areas or Calcasieu Parish may submit ERC applications for purposes of banking,” we respond that the reductions from Calcasieu Parish sources (or sources in any other attainment area) may not be used as offsets by sources in nonattainment areas, under Section 504(F)(9) of the revised NNSR rule. The reference to Calcasieu in Section 603(A) is relevant to sources in Calcasieu Parish that are seeking offsets in accordance with LAC 33:III.510.

In addition, as mentioned previously, the purpose of the LDEQ ERC revised rule is to establish the means of enabling stationary sources to identify and “preserve” or acquire emission reductions, the acceptability of which is later determined by the LDEQ, in the permitting process for NSR offsets. In spite of the fact that the revised rule is named an Emission Reduction Credit Banking regulation, the State did not adopt, nor did we propose to approve, the revised rule to function as an ERC bank or trading program. Rather, the revised rule merely provides a bulletin board to facilitate stationary source communications and offset purchases before potential certification and potential use in an NSR/NNSR permit application. The so-called “bank” in the revised rule will not itself provide ERCs that may be used for NSR/NNSR trading. The State makes a case-by-case determination in each individual permit application process about the validity of the ERCs relied upon in an application by a source owner/operator.

Comment: EPA must not approve the ERC rule revisions because LDEQ cannot provide assurance, as required by the Act, that it has adequate personnel or funding to maintain the program.

Response: The purpose of the LDEQ ERC revised rule is to function as a bulletin board to facilitate stationary source communications and offset purchases before certification and use in an NNSR permit application. The “bank” established by the revised rule will not itself provide ERCs that may be used for trading. The revised rule removes the necessity that ERCs be tracked by the State, and the requirement that there be sufficient escrowed ERCs for attainment demonstration contingency purposes. The state's and our action is simplifying the function of the bank.

Comment: Louisiana's NO X rule providing for seasonally fluctuating emission limitations for stationary sources is unworkable, introducing unnecessary complication and the potential for abuse, and reducing the public's ability to monitor the program.

Response: Because the revised rule provides for a bulletin board rather than a traditional bank, the stationary sources seeking to sell or buy ERCs will bear the brunt of whatever additional complication is introduced by the seasonal approach contained in the NO X rule. LDEQ will not be required to track or monitor a stored balance of offsets, but instead primarily to evaluate the validity of ERCs at the time it receives application to use them. The simplified function of the bank will likewise increase the public's ability to monitor the program.

Comment: EPA has stated that the NO X rule does not address the requirement to keep separate documentation for the certification, determination, and recordkeeping of NO X ERCs during the ozone and non-ozone seasons. EPA proposes to accept promises in a letter from Mr. Dale Givens regarding the operation of the bank. As of July 23, 2002, the State had not detailed the procedures required.

Response: In our proposed approval of the revised Chapter 6 ERC rule, we stated that the Chapter 6 rule (not the Chapter 22 NO X rule, as the commenter stated) “does not address the requirement to keep separate documentation for the certification, determination, and recordkeeping of NO X ERCs during the ozone and non-ozone seasons. The identification, certification, acquisition, recordkeeping and determination of “Surplus When Used” emission reduction credits must be for both the ozone season and the non-ozone season time periods.”

We did not condition our approval of the Chapter 6 rule on the receipt of additional information from the State. The stated purpose of the revised emissions banking rule in Chapter 6 is to enable stationary sources to identify and acquire emission reductions for NSR purposes. The Chapter 6 rule does not establish a “bank” requiring tracking by the State of sources' claimed ERCs. The Chapter 6 rule only establishes a bulletin board for use by source owners and operators. The LDEQ makes the determination whether a source's claimed ERCs are surplus through the Chapter 5 nonattainment NSR rules. The identification, certification, acquisition, recordkeeping and determination of “Surplus When Used” emission reduction credits must be for the ozone season and the non-ozone season time periods. The State indicated by letter from Mr. Dale Givens to EPA dated May 3, 2002 that the State would implement the rule by operating the Chapter 6 emissions reduction credits bulletin board in such a manner. EPA has received information from the State supplementing its May 3, 2002, letter and further supporting the State's intention to implement the Chapter 5 NSR rule in a manner that provides for separate identification, certification, acquisition, recordkeeping and determination of “Surplus When Used” emission reduction credits for the ozone season and for the non-ozone season time periods. For these reasons, the comment does not indicate that any change to the rule is required.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be economically significant as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This proposed action is not subject to Executive Order 13045 because this is not an economically significant regulatory action as defined by Executive Order 12866.

On November 6, 2000, the President issued Executive Order 13175 (65 FR 67249) entitled, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 took effect on January 6, 2001, and revokes Executive Order 13084 (Tribal Consultation) as of that date. This rulemaking does not affect the communities of Indian tribal governments. Accordingly, the requirements of Executive Order 13175 do not apply.

Executive Order 12898 requires that each Federal agency make achieving environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minorities and low-income populations. The EPA believes that this rule should not raise environmental justice issues. The overall result of the program is regional reductions in ozone. Because this program will likely reduce local ozone levels in the air, and because there are additional provisions under the CAA to ensure that ozone levels are brought into compliance with national ambient air quality standards, it appears unlikely that this program would permit adverse affects on local populations.

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

The Congressional Review Act, 5 U.S.C. section 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 before publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 804(2).

Pursuant to 5 U.S.C. 605(b), I certify that today's rule would not have a significant impact on a substantial number of small entities within the meaning of those terms for RFA purposes.

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

EPA believes, as discussed above, that because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty, it does not constitute a Federal mandate, as defined in section 101 of the UMRA.

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

This action merely approves a state rule implementing a Federal standard, and does not alter the relationship of the distribution of power and responsibilities established in the CAA. Thus, the requirements of section 6 of the Executive Order do not apply to this final action.

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) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

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

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. section 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 before publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Table of Contents 1. What actions are we taking in this document? 2. Why are we making this action effective immediately? 3. When did the public comment periods for our proposals expire? 4. Who submitted comments to us? 5. How do we respond to the submitted written comments? 6. What is definition of a major source for NO X ? 7. What is the history of NO X RACT rules for point sources in the BR area? 8. What are the NO X emissions factors for point sources of NO X in the BR area? 9. What is the compliance schedule for point sources of NO X in the BR area? 10. What areas in Louisiana will today's action affect? Throughout this document “we,” “us,” and “our” means EPA. 1. What Actions are we Taking in This Document?

On July 23, 2002, we proposed to approve the Louisiana's rule revisions to LAC 33:III, Chapter 22, “Control of Emissions of Nitrogen Oxides,” (AQ215), as a revision to the Louisiana SIP for point sources of NO X in the BR area and its Region of Influence. See 67 FR 48095.

The BR area constitutes the 5 ozone nonattainment parishes of Ascension, East Baton Rouge, Iberville, Livingston, and West Baton Rouge. The Region of Influence constitutes the 4 ozone attainment parishes of East Feliciana, Pointe Coupee, St. Helena, and West Feliciana. This SIP revision establishes RACT for point sources of NO X in all these 9 parishes. RACT is defined as the lowest emission limitation that a particular source can meet by applying a control technique that is reasonably available considering technological and economic feasibility. See 44 FR 53761, September 17, 1979. The State of Louisiana submitted this revision to us as a part of the NO X reductions needed for the BR area to attain the 1-hour ozone standard. These NO X reductions will assist the BR area to attain the 1-hour ozone standard.

Today, we are finalizing our approval of Action Number 1.

Action Number 2 concerns RACT for lean burn engines in 5 ozone nonattainment parishes of Ascension, East Baton Rouge, Iberville, Livingston, and West Baton Rouge. See above for definition of RACT. On July 31, 2002, we proposed to approve Louisiana's rule revisions to LAC 33:III, Chapter 22, “Control of Emissions of Nitrogen Oxides,” (AQ224), as a revision to the Louisiana SIP for lean burn engines within the BR ozone nonattainment area. See 67 FR 49647. These revisions would require lean burn engines to adopt RACT to assist the 5 nonattainment parishes to achieve the 1-hour ozone standard. See 67 FR 49647. We used a procedure known as “parallel processing” in proposing to approve these revisions. See 40 CFR part 51, Appendix V for more information on “parallel processing.” Briefly, parallel processing allows a State to submit a SIP revision prior to actual adoption by the State and provides an opportunity for the State to consider EPA comments prior to submission of a final SIP revision for final EPA review and action.

Today, we are finalizing our approval of Action Number 2.

By finalizing our approval of Action Numbers 1 and 2, we are agreeing that the State of Louisiana will be implementing RACT for major point sources of NO X in the BR area and its Region of Influence. Our TSD contains more information concerning Action Numbers 1 and 2, including technical justification for our action. For additional information concerning NO X , nonattainment areas, SIPs, federal approval of a SIP, and RACT you can refer to either 67 FR 48095 (July 23, 2002), or 67 FR 49647 (July 31, 2002).

Section 553(d) of the Administrative Procedure Act generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register . However, if an Agency identifies a good cause, section 553(d)(3) allows a rule to take effect earlier, provided that the Agency publishes its reasoning in the final rule. The EPA is making this action effective immediately because this rule is related to the Baton Rouge 1-hour ozone Attainment Plan and Transport State Implementation Plan, on which the EPA intends to take imminent action (see 67 FR 50391, August 2, 2002). In conjunction with its August 2, 2002, proposed approval of the attainment demonstration, EPA proposed to extend the ozone attainment date for the BR area to November 15, 2005, while retaining the area's current classification as a serious ozone nonattainment area and to withdraw EPA's June 24, 2002, rulemaking determining nonattainment and reclassification of the BR area (67 FR 42687). The effective date of EPA's June 24, 2002, nonattainment determination and reclassification is imminent. Furthermore, making this action effective immediately does not impose any additional requirements, because the underlying regulations are already effective under State law.

The public comment period for Action Number 1 (67 FR 48095) expired on August 24, 2002.

The public comment period for Action Number 2 (67 FR 49647) expired on September 1, 2002.

We received written comments from the Baton Rouge Clean Air Coalition (BRCAC), M. D. Mc Daniel and Associates (MDA) on behalf of the Baton Rouge Ozone Task Force, Louisiana Chemical Association (LCA), Louisiana Mid-Continent Oil and Gas Association (LAMOGA), Louisiana Generating, LLC (LG), LDEQ, NRG Energy, Inc. (NRG), and Tulane Environmental Law Clinic (TELC) on behalf of the Louisiana Environmental Action Network (LEAN) concerning Action Number 1.

We received written comments from LDEQ, LAMOGA and TELC concerning Action Number 2.

Our response to written comments concerning Action Number 1 (67 FR 48095) are as follows:

Comment #1: The BRCAC, MDA, LCA, LAMOGA, LDEQ, and LG expressed their support for our July 23, 2002 proposal (67 FR 48095).

Response to comment #1: We appreciate the commenters' support of our July 23, 2002 proposal (67 FR 48095) and have considered these comments in making our final determination.

Comment #2: The LDEQ commented on spelling of the East Feliciana and West Feliciana parishes in section 15 of our July 23, 2002 proposal (67 FR 48095).

Response to comment #2: We appreciate the comment and have corrected the typographical error in spelling of these two parishes.

Comment #3: The NRG commented that the definition of “averaging capacity” in subsection B, Chapter 22 uses the actual heat input from two prior ozone seasons and thus is limiting in nature. The Commenter proposes language for the definition that includes the term “other acceptable periods” instead.

Response to comment #3: Subsection B, Chapter 22 defines the averaging capacity as “the average actual heat input rate in MMBtu/hour at which an affected point source operated during the ozone season of the two calendar years of 2000 and 2001 ( e.g. , total heat input for the period divided by the actual hours of operation for the same period).” The provision goes on to provide, “Another period may be used to calculate the averaging capacity if approved by the department. For units with permit revisions that legally curtailed capacity or that were permanently shut down after 1997, the averaging capacity is the average actual heat input during the last two ozone seasons of operation before the curtailment or shutdown.” The rationale for specifically stating the two calendar years of 2000 and 2001 in definition of “averaging capacity” is to ensure consistency and replicability of Chapter 22 with the photochemical grid modeling inputs used for the BR area attainment demonstration. The term “acceptable periods” as suggested by the commenter could introduce confusion or ambiguity for compliance determination purposes, as well. The current definition in Chapter 22, as stated above, does provide for a source to use alternative periods pending approval by the LDEQ. Therefore, we believe that the definition, as adopted by the State, offers a harmonized blend of flexibility, consistency, and specificity and are approving the rule without any changes to subsection B.

Comment #4: The NRG commented that use of averaging capacity in subsections D.3 and D.4 of Chapter 22 essentially precludes operation of a facility at its maximum capacity if the owner elects to use a ton per day or pound per hour emission cap.

Response to comment #4: As stated previously, the rationale for specifically stating the two calendar years of 2000 and 2001 in the definition of “averaging capacity” is to ensure consistency and replicability of Chapter 22 with the photochemical grid modeling inputs used for the BR area attainment demonstration. Subsections D.3 and D.4 allow for a 30-day rolling average as the basis for calculating mass of NO X emitted per unit of heat input (lb NO X /MM Btu). The 30-day rolling average window is long enough and flexible enough to allow for potential fluctuations associated with the demand for electricity. The cap, as calculated by Equation D-1 of Chapter 22, is offered as an alternative and provides additional flexibility. If a source operated at or near its maximum capacity during the two calendar years of 2000 and 2001, then the source would be assigned a ton per day or pound per hour emission cap for NO X that is representative of its historical operations. In response to a similar comment, the State wrote and we agree,

We do not believe that an electrical power generator would want to bear the risk of having to adopt more stringent control measures or to operate under a year-round (as opposed to a seasonal) NO X control strategy for the sake of a higher cap limit that is not historically representative of its recent operations. Thus, we are approving the rule without any changes to subsections D.3 and D.4.

Comment #5: The NRG commented that compliance with the emission limits for all sources associated with the generation of electric power should be on a 30-day rolling average basis.

Response to comment #5: We disagree with the commenter. We agree with the State's response to a similar comment. In response to comments during the State rulemaking, LDEQ stated:

In other words, allowing a 30-day rolling average for electric utility boilers could result in exceedances of the one-hour standard due to varying NO X emissions caused by load variations.

Comment #6: The NRG presents a hypothetical example that should a generating unit experience an unexpected shutdown the demand for electricity must be met by other generators and the averaging capacity in section E.1.d is restrictive. The commenter then suggests that throughout Chapter 22, the term “averaging capacity” for sources associated with the electrical power generation should be replaced with “maximum rated capacity.”

Response to comment #6: We disagree. There are multiple layers of operational flexibility embedded in the Chapter 22 rule. First, Chapter 22 allows for seasonal NO X control (May 1 to September 30 of each year as opposed to a year-round) measures. See subsection A.2. The seasonal control measure by itself offers a significant degree of latitude to an affected source. Replacing the averaging capacity with maximum rated capacity as suggested by the commenter would create an artificially higher cap limit for these sources which is unrepresentative of their recent historical operations, and in turn the attainment demonstration strategy could call for implementation of more stringent control measures for the BR area. Second, Chapter 22 allows for use of the peaking services option. For the definition and emission factors of “peaking service,” see subsection B in Chapter 22, and Table I of this document, respectively. Third, Chapter 22 allows for the facility-wide averaging plan as an alternative method of compliance. Subsection E.1.b(i) offers a 30-day rolling average limit for each individual unit that fires gaseous or liquid fuels and chooses to participate in the facility-wide averaging plan. Subsection E.1.c(i) offers a 30-day rolling average limit for each individual unit, including those in a coal-fired electrical power generation system, that chooses to participate in the facility-wide averaging plan. We believe that routine maintenance, generators' know how/training, good housekeeping measures, and preventive practices should be the determining factors in minimizing or eliminating occurrences of unexpected shutdowns rather than the Chapter 22 rule. We thus disagree with the commenter in this regard.

Comment #7: The NRG commented that limiting usage of secondary fuels to the average usage of secondary fuel in 2000 and 2001 is restrictive and unnecessary.

Response to comment #7: We disagree. The Chapter 22 rule actually benefits the source by avoiding year-round NO X control requirements. See subsection A.2 of the Chapter 22 rule. The Chapter 22 rule is not overly restrictive, as it provides for an alternative method of compliance with the NO X emission factors. Subsection D.2 allows the followings options for a source which is capable of firing more than one type of fuel (primary and back-up fuel(s)):

Subsection D.2.a states “if a combination of fuels is used normally, the emission factor from Paragraph D.1 of this Section shall be adjusted by the weighted average heat input of the fuels based on the ozone season average usage in 2000 and 2001, or another period if approved by the department,”

Subsection D.2.b states “if the boiler is normally fired with a primary fuel and a secondary fuel is available for back-up, the unit shall comply with the emission factor for the primary fuel while firing the primary fuel and with the emission factor for the secondary fuel while firing the secondary fuel. In addition, the usage of the secondary fuel shall be limited to the ozone season average usage of the secondary fuel in 2000 and 2001, or another period if approved by the department,” and

Subsection D.2.c states “if the secondary fuel is less than 10 percent of the weighted average, the owner or operator may choose to comply with the unadjusted limit for the primary fuel.”

As stated previously, the rationale for specifically stating the two calendar years of 2000 and 2001 in Chapter 22 is to ensure consistency and replicability in the photochemical grid modeling inputs used for the BR area attainment demonstration. Having enforceable limits for the secondary fuel usage, and adhering to a historically representative quantity of fuel usage would benefit the source by not having to adopt year-round and more stringent controls in order for the BR area to reach attainment. Therefore, we find that limiting usage of secondary fuels to the average usage of secondary fuel in 2000 and 2001 is neither restrictive nor unnecessary and thus disagree with the commenter in this regard.

Comment #8: The NRG commented that precluding the 30-day averaging of emissions could subject the state to regulatory takings claim.

Response to comment #8: The EPA's role in reviewing SIP submittals is to evaluate whether state choices meet the criteria of the Act. Federal inquiry into the economic reasonableness and other constitutionally protected rights of state action is not allowed under the Act ( see, Union Electric Co., v. EPA, 427 U.S. 246, 255-266 (1976); 42 U.S.C. 7410(a)(2)) other than for purposes of evaluating the reasonableness and availability of alternatives for purposes of a waiver of Federal preemption. The State has submitted information indicating that the administrative requirements of Louisiana law have been met. The EPA believes this rule can be approved pursuant to the Act based on our review of the LDEQ's responses to comments, taken together with the rest of the information in the administrative record for the SIP. We thus disagree with the commenter in this regard. In approving LDEQ's adopted NO X rules, we also note the following: (a) The Chapter 22 rule calls for seasonal NO X control (May 1 to September 30 of each year) measures. See subsection A.2 of the rule, and (b) the seasonal NO X control measure by itself offers a significant degree of flexibility and latitude to an affected source.

Comment #9: The TELC requested an extension of 30 days to the public comment period.

Response to comment #9: The EPA is under no obligation to extend the comment period or to accept late comments. We decided to accept comments which were received by our office by close-of-business on August 26, 2002. This time frame corresponds to the estimated travel time for first class mail for a letter mailed and postmarked on the last day of the comment period, August 22, 2002.

Comment #10: The TELC commented that exemption of flares, incinerators, kilns and ovens in subsection B is a nonexisting section.

Response to comment #10: Chapter 22 is titled as “Control of Emissions of Nitrogen Oxides (NO X ).” Section 2201 is titled “Affected Facilities in the Baton Rouge Nonattainment Area and the Region of Influence.” Subsection B addresses the applicable definitions, and subsection C includes the exemptions. Therefore, the reference to subsection B, in the text of subsection C.7 of the rule, is valid and will remain unchanged.

Comment #11: The TELC has concerns with the emission reductions generated by facilities which are required to comply with the NO X RACT requirements in Louisiana's revised NO X rule. The commenter is concerned that facilities which elect to implement RACT before the compliance date required by the rule, May 1, 2005, could be considered to be doing so voluntarily. And as voluntary reductions, i.e., not required by federal or state law, these NO X reductions could be deemed surplus, and therefore, eligible for use as emission offsets, including offsets of Volatile Organic Compounds (VOCs).

Response to comment #11: The EPA disagrees with the commenter's interpretation that facilities which elect to implement RACT before the compliance date required by the rule, May 1, 2005, would generate reductions eligible for use as emission offsets.

The revised NO X rule requires certain affected categories of NO X -generating facilities to achieve RACT “as expeditiously as possible, but no later than May 1, 2005.” This date takes into consideration time affected categories of NO X -generating facilities may need to procure, calibrate and implement RACT. LDEQ has noted, and EPA agrees, that the May 1, 2005 date is reasonable because in the three years from the promulgation to compliance, owners and operators will have to put together design and engineering packages, procure control equipment, complete construction, shakedown and debug new equipment, and bring the NO X control equipment into normal operation. In many instances these activities will have to be coordinated with scheduled outages, which may also impact implementation schedules. Furthermore, during this same period, facilities in neighboring states will be attempting to accomplish these same activities, which could cause delays due to competition and overloading at engineering offices and equipment vendors' fabrication shops.

Section 173(c)(2) of the Act states that reductions otherwise required by the Act are not creditable as offsets. Louisiana has promulgated revisions to the Louisiana Administrative Code (LAC) at Part III, Section 504, which contains the rules for nonattainment New Source Review (NSR) procedures that apply to the Baton Rouge area. The NSR revisions include increases to the minimum offset ratios for new major stationary sources and major modifications to major stationary sources in the Baton Rouge area. The revisions also add minimum offset ratios for NO X . The EPA proposed approval of Louisiana's revised NSR rules on July 23, 2002. (67 FR 48090). For additional information regarding NSR and offsets, see LAC III:33, Chapter 5, and the separate EPA rulemaking to be issued regarding that Chapter.

Although the NO X rule permits affected categories of NO X -generating facilities to achieve compliance with NO X RACT no later than May 1, 2005, the rule became effective when promulgated on February 20, 2002 (Louisiana Register, Vol. 28, No. 2). Therefore, facilities achieving NO X RACT compliance before May 1, 2005, are creating emission reductions as required by law. Such facilities will not obtain Emissions Reduction Credits (ERCs) and cannot offset VOC emissions by early RACT implementation. Furthermore, emissions decreased by a voluntary action must be permanent in order to meet the surplus ERC criteria. Because the rule provides for compliance no later than May 1, 2005, reductions made before that date could not be considered permanent, and therefore could not be surplus.

For the above reasons, the comment does not indicate that any change to the rule is required.

Comment #12: The TELC charges that LDEQ has taken inconsistent positions regarding modeling and the effects of NO X reduction on attainment of the ozone NAAQS. The commenter points out that on January 26, 1996 (61 FR 2438), EPA granted an exemption from the RACT and NSR requirements for major stationary sources of NO X , pursuant to section 182(f) of the Act. This exemption was based on modeling submitted by LDEQ in a 1994 petition that demonstrated that additional NO X emission controls within the Baton Rouge area will not contribute to attainment of the ozone NAAQS for the area. On May 7, 2002 (67 FR 30638), EPA rescinded that exemption based on more recent modeling conducted for the Baton Rouge area, submitted by LDEQ September 24, 2001, that indicates that control of NO X sources will help the area attain the ozone NAAQS. According to the commenter, this change in approach to NO X regulation has the effect of creating “loopholes in the law.”

Response to comment #12: The “loopholes” that the commenter complains of are addressed in comment and response 11, above. This response addresses only the commenter's apparent assertion that Louisiana's scientific approach to NO X regulation is unfounded. The EPA disagrees with this argument. In granting the NO X exemptions January 26, 1996 (61 FR 2438), EPA reserved the right to reverse the approval of the exemptions if subsequent modeling data demonstrated an ozone attainment benefit from NO X emission controls. Photochemical grid modeling recently conducted for the Baton Rouge area SIP indicates control of NO X sources will help the area attain the ozone NAAQS. The State of Louisiana therefore requested that EPA rescind the NO X exemption based on this new modeling on September 24, 2001. In our proposed approval of the rescission of the NO X waiver May 7, 2002, (67 FR 30638), we stated that we believed that the State had adequately demonstrated that additional NO X reductions would contribute to attainment of ozone NAAQS. The State of Louisiana is not the only state that has requested that EPA rescind its NO X waiver based on updated photochemical grid modeling information. Seven years elapsed between the LDEQ's previous modeling demonstration that additional NO X reductions would not contribute to area's attainment, and the most recent modeling events demonstrating the Baton Rouge area to be NO X limited. Pollution control technology, including air modeling, is a dynamic and evolving field. The model used by LDEQ to support its request for approval of the NO X waiver was Urban Airshed Model (UAM) IV, which is an EPA-approved photochemical grid model. The model used by LDEQ to support its request for rescission of the NO X waiver was UAM V. This represents a significant refinement in modeling technology. Additionally, emission inventory tools have been improved during this seven year period from when the State initially requested the NO X waiver.

Comment #13: The TELC comments that the public has not been provided with the copy of the Governor's April 8, 2002, letter to EPA.

Response to comment #13: We disagree. In section 1 of our July 31, 2002 proposal (67 FR 49647), we specifically stated, “on April 8, 2002, the Governor of Louisiana submitted a letter to us requesting that we propose approval of their rule revision concerning RACT for lean burn engines through parallel processing. See 40 CFR Part 51, Appendix V for more information on parallel processing.” In addition, under the ADDRESSES portion of our July 31, 2002 proposal (67 FR 49647), we stated that: “copies of the documents relevant to this action are available for public inspection during normal business hours at the following locations. Persons interested in examining these documents should make an appointment with the appropriate office at least 24 hours before the visiting day.” The July 31, 2002, proposal (67 FR 49647) further lists both the LDEQ's and EPA's addresses at which the commenter could obtain or view the submittal package, including the April 8, 2002, letter from the Governor of Louisiana to EPA. The LDEQ noticed the rule in the March 20, 2002, issue of the Louisiana Register, and held a public hearing on April 24, 2002. Based on the foregoing information, we believe that the April 8, 2002, letter from the Governor of Louisiana to EPA and supporting documents contained in the State's submittal have been made available in the docket to the public, and therefore disagree with the commenter in this regard.

Comment #14: The TELC commented that the May 3, 2002, letter from Mr. Dale Givens of LDEQ to EPA was not made available to the public during the rulemaking and thus is a violation of due process.

Response to comment #14: We disagree. The May 3, 2002, letter from Mr. Dale Givens to EPA was made available as a part of the docket. See section 9 of our July 23, 2002, publication (67 FR 48095), and section 3 of the July 31, 2002, publication (67 FR 49647) in the Federal Register , respectively. For the reasons noted in Response #13 above, we believe that ample opportunity was provided to the public to review and comment on the documents supporting this rulemaking.

Comment #15: The TELC commented that removal of provisions (a) through (c) in subsection E.2 of Chapter 22 will mean removal of accountability/compliance requirements for facilities' trading plans.

Response to comment #15: The NO X RACT rules EPA is approving today do not contain offsetting requirements for new facilities or major modifications in attainment parishes. Thus, EPA does not find any basis in this comment to withhold full approval of Action Numbers 1 and 2. The EPA proposed to approve revisions to the Louisiana emission reduction credit (ERC) banking program (67 FR 48083, July 23, 2002). The rule was promulgated by the State at LAC 33:III, Chapter 6 (Regulations on Control of Emissions Through the Use of Emission Reduction Credit Banking), as published in the Louisiana Register on February 20, 2002. Additional information on the ERC banking program is available in our rulemaking regarding that action. The ERC banking regulation establishes a means of enabling stationary sources to identify and preserve or acquire emission reductions for NSR emission offsets.

Provisions (a) through (c) in subsection E.2 of Chapter 22 outline the information that a facility would include in its trading plan. There are several provisions and safeguards in place elsewhere in Chapters 22 and 6 that provide for compliance and accountability of the rule. For example, provisions (a) through (g) in subsection F.7, Chapter 22 detail the information that a facility would need to include in its plan in order for that plan to be considered approvable during the pre-permit application phase. Subsections G and H in Chapter 22 each contain the requirements of Initial Demonstration of Compliance, and Continuous Demonstration of Compliance, respectively. For information concerning recordkeeping and reporting requirements on banking emission reduction credits see section 613 of Chapter 6. For information concerning determination of creditable emission reductions see section 607 of Chapter 6. Taking subsections F, G, and H in Chapter 22, and sections 607 and 613 in Chapter 6 together, we disagree with the commenter's position in this regard.

Comment #16: The TELC commented that the NO X rule violates section 172(c) of the Act because it lacks requirements for minimum RACT.

Response to comment #16: We disagree. Although the Act does not define RACT, EPA has defined RACT as the lowest emission limitation that a particular source can meet by applying a control technology that is reasonably available considering technological and economic feasibility. See 44 FR 53761 (September 17, 1979). The RACT requirement is established by sections 182(b)(2) and 182(f) of the Act. Section 182(b)(2) requires States to implement RACT with respect to all major sources of volatile organic compounds (VOCs). Section 182(c) makes the requirements of section 182(b)(2) applicable to serious nonattainment areas, such as Baton Rouge. Section 182(f) states that the plan provisions required under section 182(b)(2) for major stationary sources of VOCs shall also apply to major stationary sources (as defined in section 302 and subsections 182(c), (d), and (e)) of NO X . Taken together, these sections establish the requirements for Louisiana to submit as part of its SIP a NO X RACT regulation for all major stationary sources of NO X in ozone nonattainment areas classified as moderate and above. States may also choose to develop RACT requirements on a case by case basis, considering the economic and technical circumstances of an individual source.

The EPA has published Guidance Documents to assist States in developing RACT for affected sources. As stated in section 5 of our July 23, 2002 proposal (67 FR 48095), on November 25, 1992 (57 FR 55620), we published a document of proposed rulemaking entitled “State Implementation Plans; Nitrogen Oxides Supplement to the General Preamble; Clean Air Act Amendments of 1990 Implementation of Title I; Proposed Rule,” (the NO X Supplement). The NO X Supplement describes and provides preliminary guidance on the requirements of section 182(f) of the Act. The EPA has also identified basic factors for determining RACT technological and economic feasibility in identifying RACT measures. See 57 FR 18070 (April 28, 1992). Other EPA guidance memoranda, such as those included in the “NO X Policy Document for the Clean Air Act of 1990,” (EPA-452/R96-005, March 1996), also provide more information about NO X requirements. In addition, states can use information in EPA's guidance documents known as the Alternative Control Techniques (ACTs) to develop their RACT regulations. In section 5 of our proposal (67 FR 48095), we included a table listing of ACT documents for various source categories of NO X with their corresponding EPA publication numbers. We also, in section 10 of our proposal (67 FR 48095), included a list of the affected NO X point source categories, maximum rated capacities, and their relevant emission factors.

The LDEQ developed and promulgated the NO X RACT regulation with reference to such EPA guidance ( see Louisiana's Comment Summary-Response & Concise Statement for AQ215, submitted to EPA December 2001). Although EPA has historically recommended source/category-wide presumptive RACT limits, no particular emissions control or emissions limitation automatically qualifies as RACT. Nor is there one control measure or emissions limitation that is RACT for a particular category of sources. The level of reductions required to determine RACT for a particular source depend on a number of factors, including an area's design value, a source's general process and operating procedures as well as the raw materials it uses, the net environmental impact of the control measures and economic feasibility. The level of reductions required by this rule were determined using photochemical grid modeling, an analysis of available technology and resources, and comparison to control measures instituted in other areas ( see EPA's TSD for this action and Louisiana's Comment Summary-Response & Concise Statement for AQ215, Comments 8-32). Based on the results of the modeling and an analysis of the economic and technologically feasible controls, EPA believes this regulation meets the Act's RACT requirements.

Although the commenter alleges that the NO X rule violates section 172(c) for not meeting minimum RACT, the TELC fails to provide any specific information, an individual emission factor for an affected source category, or a technological and economical evaluation/comparison to substantiate its position.

We believe that proposed NO X control measures are economically and technologically feasible, do strengthen the existing Louisiana SIP, assist to bring the BR area into attainment with the ozone standards, and constitute RACT. For these reasons we disagree with the comment.

Comment #17: The TELC commented that the NO X rule violates section 172(c)(1) of the Act because it lacks requirements for a “Reasonably Available Control Mechanism.”

Response to Comment #17: We interpret the comment as a reference to section 172(c)(1)'s requirement for “Reasonably Available Control Measures” (RACM). We disagree with the commenter. This rule addresses NO X RACT. As stated previously, EPA believes the emissions limitations contained in Louisiana's Chapter 22 NO X Rule meet the requirements for RACT. Louisiana has conducted a RACM analysis for its SIP, which is the subject of a separate rulemaking. See 67 FR 50391 (August 2, 2002). The EPA will address the State's RACM analysis in that rulemaking. The EPA has previously provided guidance interpreting the RACM requirements of 172(c)(1) in the General Preamble. See 57 FR 13498, 13560 (April 16, 1992). In the General Preamble, EPA indicated its interpretation of section 172(c)(1), under the 1990 Amendments, as imposing a duty on States to consider all available control measures and to adopt and implement such measures as are reasonably available for implementation in the particular nonattainment area. The EPA also retained its pre-1990 interpretation of the RACM provisions, stating that we would not consider it reasonable to require implementation of measures that might in fact be available for implementation in the nonattainment area, but could not be implemented on a schedule that would advance the date for attainment in the area. The EPA does not believe a RACM analysis is necessary to approve this rule. Therefore, EPA finds no basis in this comment to disapprove or revise the NO X rule.

Comment #18: The TELC commented that in its July 23, 2002 proposed approval action (67 FR 48095), EPA proposes to approve Louisiana's NO X RACT rule based on an agreement “that the State of Louisiana will be implementing RACT for point source categories.” The TELC states that this agreement does not provide for the implementation of RACT as required by the Act.

Response to comment #18: The EPA does not know to what “agreement” the commenter is referring. As explained in Comment and Response #16, above, EPA is approving this rule because it meets the requirements of sections 182(b)(2) and 182(f) of the Act. We agree that in our July 23, 2002, EPA stated, “By this approval, we are also agreeing that the State of Louisiana will be implementing RACT for point sources of NO X in the BR area and its Region of Influence.” We intended that statement to mean that, upon EPA approval, Louisiana's regulations would meet the RACT requirements of the Act. For these reasons, we find nothing in this comment to preclude our approval of this rule.

Our response to written comments concerning Action Number 2 (67 FR 49647) are as follows:

Comment #19: The LDEQ expressed its support for our July 31, 2002 proposal (67 FR 49647).

Response to comment #19: We appreciate the commenter's support of our July 31, 2002 proposal (67 FR 49647) and have considered these comments in making our final determination.

Comment #20: The TELC commented that Action Number 2 can not be part of the SIP because it has not been properly promulgated by the State and that EPA's consideration of the NO X rule in parallel proceedings is an improper procedure.

Response to comment #20: As stated in our July 31, 2002, proposal (67 FR 49647), the Governor of Louisiana submitted a letter, dated April 8, 2002, to us requesting that we propose approval of their rule revision concerning RACT for lean burn engines through parallel processing. We proposed approval of the April 8, 2002, SIP revision at the same time as the State was accepting comments and finalizing its rule revision. The method of simultaneously processing and approving a State's proposed rule revision is referred to as parallel processing. Parallel processing allows a State to submit a SIP revision prior to actual adoption by the State and provides an opportunity for the State to consider EPA comments prior to submission of final SIP revision for final EPA review and action. The 40 CFR Part 51, Appendix V provides for this method of regulatory review and SIP processing. The EPA explained its reasoning when promulgating these procedures. See also, 55 FR 5824 (February 16, 1990). As stated in our July 31, 2002, proposal (67 FR 49647), the State and EPA properly followed the parallel processing requirements of 40 CFR Part 51, Appendix V. Since the criteria set forth in 40 CFR Part 51, Appendix V have been promulgated long since, the procedural rules that allow this means of considering SIP revisions of Action Number 2 can no longer be challenged. Finally, the State's final rule revision is not significantly different from its April 8, 2002 submission (proposed rule); therefore, we will not be re-proposing our action.

The State's submittal, the Governor's letter, and our proposal to approve this particular SIP revision were made available for public review and comment, in accordance with the applicable rules, regulations, and procedures. We disagree with the commenter's position, and believe our approval of this SIP revision will strengthen Louisiana's SIP and will further safeguard the health and welfare of the public in the affected areas.

Comment #21: The LAMOGA commented that EPA's requirement to amend the capacity threshold for the lean burn engines was a last minute action.

Response to comment #21: Contrary to the LAMOGA's statement, EPA's recommendation to amend the capacity for the lean burn engines was not a last minute decision or action. In a letter to the LDEQ dated December 3, 2001, on page 11, EPA wrote: “we are concerned that major sources of NO X may not be controlled if the exemption level for lean burn engines in the NO X rule remains at 1500 horsepower (hp)... Louisiana should lower the applicability threshold for lean burn engines to insure all major sources institute RACT at a minimum as required by the Clean Air Act * * * ” In a letter to the LDEQ, dated January 24, 2002, EPA expressed its concern over this issue again by stating “we are concerned that all major sources of NO X may not be controlled sufficiently to meet the statutory RACT requirement, if the exemption level for the lean burn engines is 1500 Hp.” The LDEQ has since lowered the threshold limit for the lean burn engines and in a May 1, 2002, letter to the LDEQ we expressed our support for the State's action in this regard. The December 3, 2001, January 24, 2002, and May 1, 2002, letters are part of the docket and have been available to the public since the commencement of this rulemaking. Based on these three letters of record, we believe that there has been ample notice and opportunity for comment regarding EPA's position, and therefore disagree with the commenter's position in this regard.

Comment #22: The LAMOGA expressed its concern that the LDEQ's request to process the AQ224 rule through parallel processing was driven by mandated deadlines; otherwise, RACT would not have been triggered for lean burn engines of 320 Hp or above.

Response to comment #22: We refer to our response to comment #20 with respect to LAMOGA's comments regarding parallel processing. LAMOGA's comments indicate that the organization has been actively involved in the regulatory development arena of the BR area SIP and state's Ozone Task Force.

Section 182(b)(2) of the Act requires that a state submit a revision to its SIP that includes provisions requiring implementation of RACT under section 172(c)(1). Section 172(c)(1) of the Act requires that SIP provisions provide for implementation of RACT, at a minimum, as expeditiously as practicable to attain the NAAQS. In addition, section 182(f) of the Act states that SIP provisions required for major sources of VOCs also apply to the major sources of NO X . The BR area was designated a serious ozone nonattainment area (40 CFR 81.319). According to section 182(c) of the Act, a major source in a serious nonattainment area is a source that has a potential to emit 50 tpy or more of NO X . Lean burn engines of 320 hp and above have the potential to emit 50 tpy or more of NO X . See Pages 9 and ten of our TSD for this rulemaking. The 40 CFR Part 51, Appendix V provides for a state to request EPA to process revisions to its SIP as the state is accepting comments and finalizing its rule revision. We believe that the above listed statutory requirements of the Act are the driving forces for adoption of AQ224. While we appreciate the commenter's statement for not wanting to jeopardize approval of the BR area ozone attainment demonstration SIP, we also note that the major source threshold for a stationary source in a severe ozone nonattainment area is 25 tpy. The 25 tpy cut-off could potentially subject additional lean burn engines in the BR area to RACT requirements if the current measures are not adopted or implemented accordingly. The proposed lean burn engine requirements can be met with combustion modifications and without utilizing post combustion control technology measures. The Chapter 22 NO X rule provides for operational flexibility through facility-wide averaging provisions of which a source may want to take advantage. See subsection E in Chapter 22.

Comment #23: The LAMOGA commented that LDEQ has not adequately demonstrated RACT for lean burn engines between 320 and 1500 Hp.

Response to comment #23: We disagree. The NO X emission factor for lean burn engines of 320 Hp or higher in size, within the BR area, is set forth at 4 grams/Hp-Hour. See Subsection D.1 in Chapter 22. The EPA has received documentation from an affected facility in the BR area that this level of control for such engines can be easily and cost-effectively achieved. This documentation is part of the docket and available to the public for review. The NO X emission factor for lean burn engines as set forth in Chapter 22 rule is consistent with the findings of the report titled “Stationary Reciprocating Internal Combustion Engines, Updated Information on NO X Emissions and Control Techniques'' dated September 1, 2000. See Pages 4-4 and 4-12 of this report. You can find this report at: http://www.epa.gov/ttnnaaqs/ozone/rto/fip/data/rfic_engine.pdf.

The commenter's claim that the controls are not cost-effective, and consequently not RACT, is wrong for a number of reasons. First, it appears that the commenter has selectively chosen the hours of operation so that its measure of cost effectiveness is biased. Second, in any event, as in any technology-based scheme, the focus must be first on emission reduction, not on cost. See e.g. Husgvarna AB v. EPA, 254 F 3d 195,200 (D.C. Cir. 2001)(cost considerations are subordinate to emission reduction goals of technology-based requirement); Lignite Energy Council v. EPA, 198 F 3d 930, 933 (D.C. Cir. 1999)(emission reductions resulting from technology based scheme must be sustained unless economic or environmental costs are “exorbitant”). As stated previously, an affected facility in the BR area has submitted documentation showing that it, as well as other affected facilities, are capable of achieving emissions levels well below the required limit for lean burn engines. This documentation corroborates the State's and EPA's similar conclusions. Therefore, the economic or environmental costs to the commenter can not be considered exorbitant. Furthermore, it is entirely unreasonable for an uncontrolled major source to selectively choose a desirable number of “hours per year” to arrive at a higher value for cost per ton of NO X in its economic analysis, declare control requirements to be economically infeasible based on this faulty accounting, and thus continue operation absent of any control measures. Based on foregoing information, we believe that Chapter 22 requirement for lean burn engines is technologically and economically feasible, and consider the State's RACT limits to be reasonable.

Comment #24: The LAMOGA suggests that LDEQ may consider, at a later date, to amend (relax) the NO X emission limits for lean burn engines.

Response to comment #24: While attaining the ozone NAAQS in BR area is a formidable challenge for both the regulated community and regulating entities, maintaining the standard could prove to be an even more challenging task. The EPA notes that any future revisions to the SIP in the BR area would have to meet the requirements of the Act, including section 110, and must continue to demonstrate attainment.

This concludes our responses to the received written comments concerning Actions Number 1 and 2.

The BR area was designated as a serious ozone nonattainment area (40 CFR 81.319). According to section 182(c) of the Act, a major source in a serious nonattainment area is a source that emits, when uncontrolled, 50 tpy or more of NO X . Therefore, the major source size for NO X within these 9 parishes is 50 tpy or more, when uncontrolled.

Prior to our proposed rulemaking actions (67 FR 48095 and 67 FR 49647) the Louisiana's approved SIP did not a contain NO X RACT rule for point sources operating in these 9 parishes. We believe that implementation of today's rule revisions will assist in bringing the BR area into attainment with the federal 1-hour ozone standard, and will strengthen the existing Louisiana SIP.

The following Table contains a summary of the affected NO X point source categories, maximum rated capacities, and their relevant emission factors based on the February 27, and July 25, 2002, SIP submittals. See LAC 33:III:2201, section D(1). Table I—Affected Categories of NO X , Maximum Rated Capacities, and Emission Factors in the BR area

We believe that the above NO X emission factors for point sources of NO X in the BR area and Region of Influence will assist in bringing the BR area into attainment with the federal 1-hour ozone standard, and will strengthen the existing Louisiana SIP. See section II, A.5, 67 FR 50391 (August 2, 2002).

By this approval we are agreeing that the State of Louisiana will be implementing RACT for point source categories listed in Table I of this document.

The compliance date for point sources of NO X in the BR area is as expeditiously as possible, but no later than May 1, 2005. See LAC 33:III:2201, sections J(1) and (2). We believe that the compliance schedule for point sources of NO X in the BR area will assist in bringing the BR area into attainment with the federal 1-hour ozone standard, and will strengthen the existing Louisiana SIP.

The following table contains a list of Parishes affected by today's rulemaking.

If you are in one of these Louisiana parishes, you should refer to the Louisiana NO X rules to determine if and how today's action will affect you.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet home page at http://www.epa.gov/ . To access this document, on the home page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development. 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-2002-0225. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of May 23, 2001 (66 FR 28470) (FRL-6780-7), 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 a pesticide petition (PP 0F6139) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-3528. This notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.582 be amended by establishing tolerances for combined residues of the fungicide pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), expressed as parent compound, in or on almond, hulls at 1.6 parts per million (ppm); banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw] at 8.5 ppm, and combined residues of pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, in or on cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; and sheep, meat byproducts, except liver at 0.2 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 the establishment of tolerances for combined residues of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), expressed as parent compound in or on almond, hulls at 1.6 ppm; banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw] at 8.5 ppm, and combined residues of pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound], in or on [cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; and sheep, meat byproducts, except liver at 0.2 ppm.]. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The acute toxicity of pyraclostrobin is presented in the following table 1:

The subchronic and chronic toxic effects caused by pyraclostrobin, as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed, are discussed in the following Table 2.

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 X 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for pyraclostrobin used for human risk assessment is shown in the following Table 3:

1. Dietary exposure from food and feed uses . Tolerances are being established (40 CFR 180.582) for the residues of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and one or more of its metabolites, expressed as parent compound], in or on a variety of raw agricultural commodities. These tolerances include almond, hulls at 1.6 ppm; Banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; sheep, meat byproducts, except liver at 0.2 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw at 8.5 ppm. Risk assessments were conducted by EPA to assess dietary exposures from pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester)] in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following determinations and assumptions were made for the acute exposure assessments: The aPAD for the subgroup females (13-50 years old) is much lower than the aPAD for the U.S. population group and the other subgroups assessed (see table 3 of this preamble) because of the much lower NOAEL used for the females (13-50 years old) subgroup and the 3x FQPA SF applied only to this subgroup, to protect against effects seen following in utero exposure in the developmental rabbit study. In these assessments percent crop treated data were used for a number of commodities but anticipated residues were not, so the assessments are considered to be partially refined and somewhat conservative. Concentration factors for processed commodities were also used. Refinements such as the use of anticipated residue estimates would potentially produce much lower estimates of dietary exposure. The results, at the 95 th percentile, of the acute dietary exposure analysis were that the general U.S. population and all subgroups except females (13-50 years old) had dietary exposures that were < 1.0% of the aPAD. Females (13-50 years old) had a dietary exposure that was 41% of the aPAD.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the valuation DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The same cPAD was applicable to the general U.S. population and all subgroups in the chronic dietary exposure analysis. In this assessment PCT data were used for a number of commodities but anticipated residues were not, so the assessments are considered to be partially refined and somewhat conservative. Concentration factors for processed commodities were also used. Refinements such as the use of anticipated residue estimates would potentially produce much lower estimates of dietary exposure. The chronic pyraclostrobin dietary exposure analysis estimated the following exposures: (a) General U.S. population - 27% of the cPAD, (b) children (1-6 years old) - 74% of the cPAD, and (c) children (7-12 years old) - 41% of the cPAD, infants ( < 1-year old) - 31% of the cPAD. All other subgroups analyzed had exposures lower than that of the general U.S. population.

iii. Cancer . The database for carcinogenicity for pyraclostrobin is incomplete because the maximum dose levels for female mice and rats in the carcinogenicity studies are inadequate. The Agency considered a method of expressing potential cancer risk using a linear (Q1*) method based on mammary tumors in female rats, to put an upper limit on any possible cancer risk. However, statistical analyses of the tumor data from the combined results of the rat carcinogenicity and chronic toxicology studies showed neither a significant increasing trend nor a significant difference in the pair-wise comparison of the dosed groups with the controls. In Consultation with the Pest Management Regulatory Agency (PMRA), Canada, with whom pyraclostrobin has been jointly reviewed, it was decided that a MOE method would be more appropriate. The reason is that the genotoxicity data show that pyraclostrobin is not mutagenic and the highest dosage level in female rats can be interpreted as a NOAEL for cancer. The Agency therefore believes that it can make a reasonable certainty of no harm determination for carcinogenicity by calculating MOEs, based on the following endpoints: (a) NOAELs of 3.4 (for males) and 12.6 (for females) mg/kg/day from the 2-year carcinogenicity rat feeding study and (b) the NOAEL of 9.0 mg/kg/day from the 28-day rat feeding study.

The NOAEL of 3.4 mg/kg/day is based upon chronic toxicity findings at the LOAEL of 9.2 mg/kg/day, including decreased body weight and body weight gain, kidney tubular casts, and kidney atrophy in both sexes; increased incidence of liver necrosis, erosion/ulceration of the glandular stomach and forestomach, and hemolymphoreticular tumors in males; and mammary adenocarcinoma in females. However, the observed increase in incidences of kidney tubular casts atrophy are commonly found in this strain of rat and were considered by the Agency to be strain and/or age related. The increased incidence of acanthosis and ulcers of the forestomach in both sexes were seen at necropsy late in the study and were considered to be of equivocal toxicological significance, but could not be ruled out as treatment-related effects. The NOAEL of 12.6 mg/kg/day for a cancer scenario is the highest tested dose in the rat oral carcinogenicity study and, though it is considered to be inadequate for assessing carcinogenicity in female rats because they could have tolerated a higher dose, it still is suitable for use as a NOAEL for the possibility of cancer induction in female rats. The dosing in males at 200 ppm (9.2 mg/kg/day) is considered to approach an adequate level because there was a (minimal) decrease of 7% of body weight and a reduction of up to 10% in body weight gain in addition to the slightly increased incidence of erosion/ulceration of glandular stomach and forestomach. The rat carcinogenicity study, rather than the mouse carcinogenicity study, was used for endpoint selection because the NOAELs in the latter study are higher.

The NOAEL of 9.0 mg/kg/day from the 28-day rat feeding study, based on increased incidences of duodenal mucosal hyperplasia in rats of both sexes at the LOAEL of 42.3 mg/kg/day, was selected based on the hypothesis that the observed hyperplasia would progress to duodenal neoplasia following long-term exposure to pyraclostrobin. This endpoint was also noted in the 13-week rat feeding study, with a NOAEL of 10.7 mg/kg bodyweight per day, and in the range-finding reproductive toxicity study.

The dietary MOEs from residues in food and water that were calculated from the above three endpoints were 1,100 for the NOAEL of 3.4 mg/kg/day, 3,200 for the NOAEL of 9.6 mg/kg/day, and 4,200 for the NOAEL of 12.6 mg/kg/day.

iv. Anticipated residue and percent crop treated (PCT) 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 subpopulation group; and condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

In the pyraclostrobin risk assessment the Agency used PCT data as follows. PCT values of 100% were assumed where no more-refined data were available. EPA utilized PCT values of less than 100% for the following commodities: Beet, sugar; berry, group; fruit, citrus, group; fruit, stone, group; grain, cereal, group; grape; nut, tree, group; pea and bean, dried shelled, except soybean, subgroup; peanut; pistachio; potato; strawberry; tomato; vegetable, bulb, group; vegetable, cucurbit, group; and vegetable, root and tuber, group. These PCT values are based on projected market share information. The registrant provided the Agency with their anticipated market share projections. The Agency estimated market share projections comparing the efficacy spectrum of the registered alternatives to the spectrum of pyraclostrobin. In conducting its risk assessment, the Agency utilized the EPA-derived estimates. The Agency believes that this approach is conservative and will overestimate the potential risk. To further ensure the reliability of these data, as a condition of registration, the registrant will be required to provide annual reports on the market penetration and market share of pyraclostrobin for each of the registered crops.

The Agency believes that the three conditions listed above have been met. With respect to condition 1, PCT estimates are derived from company-provided anticipatory data that have been reviewed by the Agency and are believed to be reliable and to have a valid basis. Since there are not any use data for a new pesticidal active ingredient prior to its initial registration, the Agency believes that company anticipatory estimates provide the best initial estimation of PCT data and is reasonably certain that the percentage of the food treated is not likely to be an underestimation. Conditions 2 and 3 are satisfied by the use of regional consumption data and consumption data for significant subpopulations in EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of these consumption data in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which [pyraclostrobin] may be applied in a particular area.

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

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce surface water estimates of pesticide concentrations in an index reservoir. The Screening Concentration In Ground Water (SCI-GROW) 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 treated (PCT) 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 points 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 pyraclostrobin they are further discussed in the aggregate risk sections.

Based on the FIRST and SCI-GROW models the EECs of pyraclostrobin for acute exposures are estimated to be 20.4 parts per billion (ppb) for surface water and 0.009 ppb for ground water. The EECs for chronic exposures are estimated to be 0.79 ppb for surface water and 0.009 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). However, pyraclostrobin is not registered for use on any sites that would result in residential exposure. .

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

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

1. In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a 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 . Qualitative (but not quantitative) evidence of increased susceptibility to pyraclostrobin of infants and children, as compared to adults, was seen in the prenatal development study in rabbits, but neither qualitative nor quantitative evidence of increased susceptibility to pyraclostrobin was seen in rats.

3. Conclusion . There is an incomplete toxicity database for pyraclostrobin, but exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency concluded, despite the 2-generation reproduction study of rats data gap, that the FQPA SF can be reduced to 3x for pyraclostrobin because: (a) Only qualitative susceptibility was seen and this occurred in only one species, (b) there is no qualitative or quantitative evidence of increased susceptibility following in utero exposure to pyraclostrobin in the prenatal development study in rats, (c) a developmental neurotoxicity study is not required, and (d) the dietary (food and drinking water) and residential exposure assessments do not underestimate the potential exposure for infants, children, or women of childbearing age. The 3x FQPA SF was derived prior to finalizing the FQPA SF guidance document on January 31, 2002. A formal reconsideration of the FQPA SF was not made but the Agency did consider the effect of the application of the “weight of evidence” approach described in the guidance document on the value of the safety factor. It was concluded that the 3x FQPA SF established prior to the completion of the guidance document would not increase since the developmental effects in the rabbit prenatal developmental toxicity study are well characterized and the NOAEL for these effects is established. Therefore, there is no need for an additional FQPA SF to address potential prenatal or postnatal toxicity. In other words, for acute dietary and residential exposure assessment of the females 13-50 years old population subgroup, the 3x FQPA SF would likely be reduced to 1x. Also, the 3x FQPA SF for assessing chronic dietary and residential exposures would not increase because of the data base deficiency of the 2-generation reproduction study. The reproduction study that was submitted was rejected solely because it did not test at a high enough dose to identify toxicity. In that study, there was no parental systemic, reproductive, or offspring toxicity at any dose including the top dose of 29-36 mg/kg/day, which is well above the NOAELs of other repeated dose toxicity studies. Thus, conduct of another reproduction study will better define reproductive effects at high doses but, in all likelihood, will have no effect on the RfD.

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, at the 95 th percentile the acute dietary exposure to pyraclostrobin from food will occupy < 1.0% of the aPAD for the U.S. population, 41% of the aPAD for females 13-50 years old, < 1.0% of the aPAD for infants ( < 1-year old), and < 1.0% of the aPAD for children (1-6 years old). In addition, there is potential for acute dietary exposure to pyraclostrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 4:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to [pyraclostrobin] from food will utilize 27% of the cPAD for the U.S. population, 31% of the cPAD for infants < 1-year old, and 74% of the cPAD for children (1-6 years old). There are no residential uses for pyraclostrobin that result in chronic residential exposure to pyraclostrobin. However, there is potential for chronic dietary exposure to pyraclostrobin 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 5:

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

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

5. Aggregate cancer risk for U.S. population . The database for carcinogenicity is incomplete. MOEs have been calculated for chronic (cancer) food exposure based on NOAELs of 3.4 and 12.6 mg/kg/day from the 2-year carcinogenicity feeding study in rats and a NOAEL of 9.0 mg/kg/day from the 28-day rat feeding study. MOEs for drinking water exposure, using the SCI-GROW model chronic estimate of 0.009 ppb pyraclostrobin in ground water, are presented in the following table 6 as are the MOEs for food plus drinking water.

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 pyraclostrobin residues.

Two tolerance enforcement methods have been proposed by BASF for the determination of pyraclostrobin and its desmethoxy metabolite (BF 500-3) in or on plant commodities: (a) The Liquid Chromatography/Mass Spectrometry (LC/MS) method number D9808 and (b) the HPLC/UV method number D9904. The validated method limits of quantitation for pyraclostrobin and BF 500-3 for both methods are 0.02 ppm for each analyte in plant matrices. Adequate independent method validation and radiovalidation data have been submitted for both methods. These methods have been forwarded to the Agency's Analytical Chemistry Laboratory for validation.

The Agency has also received two tolerance enforcement methods for ruminant commodities: HPLC/UV method number 439/0 and 446, which consists of Gas Chromatography (GC)/MS method number 446/0 and LC/MS/MS method number 446/1. The HPLC/UV method determines residues of pyraclostrobin per se. Method number 446 has a hydrolysis step and determines residues of pyraclostrobin and its metabolites as the molecules BF 500-5 and BF 500-8. These methods have also been forwarded to the Agency's Analytical Chemistry Laboratory for validation.

The petitioner must make any modifications or revisions to the proposed methods resulting from the Agency's validation. Upon successful completion of the validation, the methods will be forwarded to FDA for publication in a future revision of the Pesticide Analytical Manual, Volume II (PAM-II). Before publication and upon request, the methods will be available, prior to the harvest season, from the Analytical Chemistry Branch (ACB), Biological and Economic Analysis Division (7503C), Environmental Science Center, 701 Mapes Road, Ft. George C. Meade, MD 20755-5350. Contact Francis D. Griffith, Jr., telephone (410) 305-2905, e-mail: griffith.francis@epa.gov . The analytical standards are also available from the EPA National Standard Repository at the same location.

Pyraclostrobin was successfully evaluated through several of the FDA multiresidue method protocols, while BF 500-3 was unsuccessful in all protocols. Pyraclostrobin was completely recovered through Protocol D (in grape) and E (in grape), and partially recovered through Protocol F (in peanut). Metabolite BF 500-3 had poor peak shape and inadequate sensitivity with Protocol C columns and therefore was not further analyzed under Protocols D, E, and F. The results of the multiresidue testing for pyraclostrobin will be forwarded to FDA for inclusion in PAM Volume I.

No Codex or Mexican maximum residue levels (MRLs) have been proposed or are established for residues of pyraclostrobin. Therefore, no tolerance discrepancies exist between countries for this chemical. Since the application for registration of pyraclostrobin was reviewed jointly with the Pest Management Regulatory Agency (PMRA) of Canada, several Canadian MRLs for pyraclostrobin are proposed and are expected to be established soon. However, the joint review is expected to have eliminated the potential for discrepancies between U.S. tolerances and Canadian MRLs.

Therefore, tolerances are established for combined residues of pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy metabolite methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate, expressed as parent compound, in or on almond, hulls at 1.6 ppm; Banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw at 8.5 ppm, and combined residues of pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, in or on cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; and sheep, meat byproducts, except liver at 0.2 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-2002-0225 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0225, 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 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-2002-0204. 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 October 8, 1997 (62 FR 52588-52563) (FRL-5748-6) and May 12, 2000 (65 FR 30591-30596) (FRL-6497-1), EPA issued notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of pesticide petitions (PP 7F4875 and 0F6092) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 27419-8300. These notices included a summary of the petition prepared by Syngenta, the registrant. There were no comments received in response to the notice of filing.

The petition(s) requested that 40 CFR 180.438 be amended by establishing a tolerance for residues of the insecticide lambda-cyhalothrin, in or on almond, hulls at 1.5 parts per million (ppm); apple pomace, wet at 2.50 ppm; avocados (imported) at 0.20 ppm; canola, seed at 0.15 ppm; cereal grain crop group (except rice and wild rice), grain, at 0.2 ppm; forage (except sorghum) at 6.0 ppm; hay at 2.0 ppm; straw at 2.0 ppm; aspirated grain dust at 2.0 ppm; bran at 0.8 ppm; flour at 0.6 ppm; fruit, pome, group at 0.3 ppm; fruit, stone, group at 0.50 ppm; nut, tree, group at 0.05 ppm; peanut, hay at 3.0 ppm; peas and beans - dried shelled, (except soybean), subgroup at 0.1 ppm; peas and beans - succulent shelled, subgroup at 0.01 ppm; sorghum, grain, forage at 0.3 ppm; sorghum, grain, stover at 0.5 ppm; sugarcane at 0.05 ppm; vegetables, fruiting, group (except cucurbits) at 0.2 ppm; and vegetables, legumes, edible podded subgroup at 0.2 ppm.

EPA has concluded that the tolerance requests for the cereal grain crop group are unacceptable at this time since additional residue field trial data are necessary in support of these tolerances. PP 0F06092 proposed a tolerance for canola seed of 0.15 ppm, subsequently revised in this final rule to 1.0 ppm on canola and 2.0 ppm in canola oil.

In addition, existing tolerances under § 180.438(a) for tomatoes at 0.1 ppm is no longer needed. It is being replaced with the new tolerance for the vegetables, fruiting, group (except cucurbits) at 0.2 ppm. In addition, existing tolerances for the section 18 emergency exemption under § 180.438(b) for sugarcane at 0.03 ppm is not needed since a tolerance is established by this regulation rule under § 180.438(a) for sugarcane at 0.05 ppm.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of lambda-cyhalothrin on almond, hulls at 1.5 ppm; apple pomace, wet at 2.50 ppm; avocados (imported) at 0.20 ppm; canola, seed at 0.15 ppm; fruit, pome, group at 0.3 ppm; fruit, stone, group at 0.50 ppm; nut, tree, group at 0.05 ppm; peanut, hay at 3.0 ppm; peas and beans - dried shelled, (except soybean), subgroup at 0.1 ppm ; peas and beans - succulent shelled, subgroup at 0.01 ppm; sorghum, grain, forage at 0.3 ppm; sorghum, grain, stover at 0.5 ppm; sugarcane at 0.05 ppm; vegetables, fruiting, group (except cucurbits) at 0.2 ppm; and vegetables, legumes, edible podded subgroup at 0.2 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by lambda-cyhalothrin are discussed in the Table 1 below as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed. Note that studies discussed below were conducted using either cyhalothrin or lambda-cyhalothrin. Cyhalothrin and lambda-cyhalothrin are basically the same chemical, the differences are found in their stereo chemistry and the number of isomers in each mixture. Cyhalothrin consists of four stereo isomers in each mixture. Cyhalothrin consists of four steno isomers while lambda-cyhalothrin is a mixture of the two isomers. The two lambda-cyhalothrin isomers are contained in cyhalothrin and they represent 40% of the cyhalothrin mixture. The major studies submitted to the Agency were conducted with cyhalothrin. However, these studies are used in support of registration for both mixtures. There is evidence, based on subchronic studies in rats, that the two mixtures are not biologically different with respect to their mammalian toxicity.

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

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

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

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

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.438) for the residues of lambda-cyhalothrin, in or on a variety of raw agricultural commodities. Currently established tolerances for residues of lambda-cyhalothrin are listed under 40 CFR 180.438 and include permanent tolerances on plants ranging from 0.01 ppm on soybeans to 10.0 ppm on hops. Tolerances are also established for aspirated grain fractions, the head and stem Brassica subgroup, corn, cotton seed, dry bulb onions, lettuce, peanuts, soybeans, sorghum, sunflowers, tomatoes, and wheat; and on animal commodities ranging from 0.01 ppm in eggs, poultry meat, and poultry meat by-products to 5.0 ppm in milk fat (reflecting 0.2 ppm in whole milk). A tolerance of 0.01 ppm has been established for residues in foods potentially exposed to the insecticide during treatment of food handling establishments. A temporary tolerance for canola (0.1 ppm) is listed as expired as of 12/31/00.

Lambda-cyhalothrin is used to control a wide range of pests (including aphids, adult Japanese beetles, grasshoppers, and butterfly larvae) in a variety of agricultural applications and crops. For some crop uses, it is applied to soil before crops emerge. Current non-agricultural uses include ornamental gardens, lawns, landscapes, turf, golf courses, and general insect control (spot treatments and crack and crevice treatments) in around and on buildings, structures, and immediate surroundings. It may also be used for structural pest management and in public health applications to control insects such as mosquitoes, cockroaches, ticks, and flies, which may act as disease vectors. Other uses include ear tags and pour-ons for beef cattle.

Risk assessments were conducted by EPA to assess dietary exposures from lambda-cyhalothrin in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: A refined Tier 3 probabilistic acute dietary risk assessment was conducted for all currently registered and proposed lambda-cyhalothrin food uses. The acute dietary assessment includes dietary exposures calculated in a previous dietary assessment (Risk Assessment for Extension of Tolerances for Synthetic Pyrethroids, (62 FR 63002, Nov. 26, 1997; FRL-5755-5) as well as dietary exposures calculated for proposed uses.

The following data for the commodities with proposed new uses and tolerances were added to the original analysis: The entire distribution of residue field trial data was used for not-blended or partially-blended commodities; average residue field trial data were used for blended commodities; information from cooking and processing studies were used when available; and market share data for proposed and established tolerances were used.

For this updated analysis, with the exception of peas and beans (Crop Group 6), commodities as part of a crop group for which tolerances were proposed but data on each individual crop were not submitted, were analyzed using tolerance levels and 100%CT. For example, apples and pears, the representative crops for pome fruits, included residue field trial data and market share data which were included in the analysis. The remainder of the crop group was analyzed using tolerance level residues and 100%CT. The exception, peas and beans (Crop Group 6), used the submitted residue field trial data and market share data as appropriate for the entirety of each subgroup. In accordance with present EPA policy, potential residues from uses in food handling establishments were not included in the acute assessment.

The original 1997 analysis included probabilistic methods for acute dietary analyses for cattle (beef and dairy) to select the feed items comprising the potential cattle diets and associated residues. The same livestock information was used for the present analysis since the additional uses are not expected to increase dietary burden.

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 CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: This chronic dietary assessment includes dietary exposures calculated in a previous dietary assessment (Risk Assessment for Extension of Tolerances for Synthetic Pyrethroids, (62 FR 63002, Nov. 26, 1997, FRL-5755-5) as well as dietary exposures calculated for proposed uses.

The following data for the commodities with proposed new uses and tolerances were added to the original analysis: average of the residue field trials, information from cooking and processing studies, and market share data.

The original chronic dietary analysis (1997) included dietary burdens calculated using mean field trial residues, adjusted for percent of crop treated and applying appropriate processing factors, for all animal feed items and associated residues. For the updated analysis, with the exception of peas and beans (Crop Group 6), commodities as part of a crop group for which tolerances were proposed but data on each individual crop were not submitted were analyzed using tolerance levels and 100%CT. For example, apples and pears, the representative crops for pome fruits, included residue field trial data and market share data which were included in the analysis. The remainder of the crop group were analyzed using tolerance level residues and 100%CT. The exception, peas and beans (Crop Group 6), used the submitted residue field trial data and market share data as appropriate for the entirety of each subgroup.

In addition, the food handling establishment tolerance was included in the chronic analysis for all foods which did not have individual proposed or established tolerances. Since the tolerance was based on the LOQ, half of the LOQ was used in the chronic dietary analysis.

iii. Cancer . The database for carcinogenicity is considered complete, no additional studies are required at this time. The requirements for carcinogenicity studies in the rat and the mouse with lambda-cyhalothrin have been satisfied by a combined chronic/carcinogenicity study in rats and a carcinogenicity study in mice, both conducted with cyhalothrin. Although mice should have been tested at a higher dose, it was determined that there was not enough toxicological concern to warrant a requirement for a new carcinogenicity study in mice. Therefore, a dietary exposure assessment was not conducted. See Unit III.E.5 of this preamble for further discussion.

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

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

For existing uses, the Agency used estimates of PCT for the acute and chronic exposure assessments which were determined using Doanes market survey data (1998-2000). The following PCT estimates were used for existing registrations: alfalfa 1.8%; broccoli 13.11%; bulb onions/garlic 45.53%; cabbage 31.33%; sweet corn 43.61%; cotton 12.97%; lettuce (head and leaf) 20.47%; rice 10.33%; soybean 0.2%; squash 0.24%; tomatoes 21.03%; wheat 1.13%; and food handling establishments (13.7 %).

The Agency believes that the three conditions listed in Unit III.C.1.iv. of this preamble have been met. With respect to Condition 1, PCT estimates are derived from market survey data, which are reliable and have a valid basis. EPA uses an average PCT for chronic dietary exposure estimates. An 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 assessments, the Agency incorporates PCT information by creating a residue distribution file which includes the measured residue values from field trials, and zero residue values added to account for the percent of crop not treated. This approach is used only for nonblended or partially blended commodities as defined under EPA SOP99.6. For blended commodities, a single point estimate is created from the residue value multiplied by the upper bound PCT. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation.

For the new uses, the Agency used PCT estimates for acute and chronic exposure based on market share projections as follows: almonds 11.72%; apples 2.69%; avocados 2.0%; canola seed 1.87%; cherries 17.3%; dried shelled beans and peas 13.41%; edible podded beans and peas 0.40%; hazelnuts 17.91%; peanuts 4.53%; peaches 20.73%; pears 4.84%; pecans 12.5%; peppers 6.24%; sorghum 1.43%; succulent shelled beans and peas 0.84%; sugarcane 3.97%; and walnuts 11.82%.

The Agency believes that the three conditions previously discussed have been met regarding %CT estimates for the new lambda-cyhalothrin uses. With respect to Condition 1, EPA finds that the %CT information described in Unit II.C.1(iv) for lambda-cyhalothrin is reliable and has a valid basis. To support the use of these PCT estimates, the Agency has compared these estimates to existing usage data for currently registered insecticides used on the proposed lambda-cyhalothrin crop sites. Based on this comparison these estimates should not underestimate actual usage of lambda-cyhalothrin on the new crops/sites. The Agency also conducted a DEEM® analysis using the highest percent crop treated for a competing alternative chemical for apples and peaches, high dietary contributors, and determined no significant increase in the acute RFD. To further support the reliability of these %CT estimates, as a condition of registration, the registrant will be required to agree to report annually on the market share attained for the new uses for which lambda-cyhalothrin is registered. As a condition of registration, they will also be required to agree to mitigate dietary risk as deemed appropriate by the Agency should the market share data raise a concern for increased dietary risk. The Agency will then compare that market share information with the percent crop treated estimates used to evaluate potential dietary risk. In those instances where percent market share is approaching or exceeding the predicted percent crop treated estimate used in the Agency's risk assessment, EPA will conduct a new dietary risk assessment to evaluate the new dietary risk. If the market share data raise a concern for increased pesticide risk, the Agency will act to mitigate that dietary risk and could employ several approaches not limited to production caps, geographical limitations, removal of uses, or other means deemed appropriate by the Agency. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which lambda-cyhalothrin may be applied in a particular area.

2. Dietary exposure from drinking water . Environmental fate studies suggest that lambda-cyhalothrin is moderately persistent in the environment, with laboratory half-lives ranging from 13-73 days and the field half-lives ranging from 12 to 63 days. This chemical has a strong tendency to bind to soil and sediments (Kd=1,970-7,610). The low mobility (due to high Kd) indicates that ground water contamination with the insecticide is highly unlikely. However, under runoff conditions, lambda-cyhalothrin is likely to reach surface water resources bound to soil particles. Once in the water system, lambda-cyhalothrin tends to partition to sediments.

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

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 SCI-GROW 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 lambda-cyhalothrin they are further discussed in the aggregate risk sections.

Based on the FIRST and SCI-GROW models the EECs of lambda-cyhalothrin for acute exposures are estimated to be 0.62 parts per billion (ppb) for surface water and 0.012 ppb for ground water. The EECs for chronic exposures are estimated to be 0.098 ppb for surface water and 0.012 ppb for ground water. The EECs for lambda-cyhalothrin are based on an application of the insecticide to sweet corn at a maximum of 16 applications per year at a rate of 0.48 lb active ingredient per acre per application.

3. 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).

Lambda-cyhalothrin is currently registered for use on the following residential non-dietary sites: ornamental gardens, lawns, landscapes, turf, golf courses, and general insect control (spot treatments and crack and crevice treatments) in, around, and on buildings, structures, and immediate surroundings. The risk assessment was conducted using the following residential exposure assumptions: A review of current labels indicates that all products, except for one aerosol can product, are limited to use only by certified applicators. As such, this assessment addresses the single residential handler scenario and postapplication scenarios associated with any use in a residential environment. It should be noted that the residential exposure/risk assessment is based on both proposed and existing uses for lambda-cyhalothrin because all potential residential exposures must be considered in the calculation of aggregate risks.

A non-occupational (residential) exposure assessment for lambda-cyhalothrin was completed in 1997 in conjunction with the Risk Assessment for Extension of Tolerances for Synthetic Pyrethroids (62 FR 63002, Nov. 26, 1997, FRL-5755-5). In the 1997 pyrethroid assessment, due to the wide variety of residential uses, it was agreed that flea control (simultaneous use on pets, lawns and indoor surfaces) would serve as a screening level scenario for all residential uses because it was anticipated to represent the highest potential for residential exposure. However, at that time, lambda-cyhalothrin uses did not include indoor surfaces or pets, so only exposure estimates pertaining to the lawn uses were used as appropriate in the 1997 assessment for lambda-cyhalothrin.

The 1997 lambda-cyhalothrin assessment served as the basis for the current risk calculations. The only modifications have been adjusting the values from the 1997 assessment for appropriate absorption factors. This represents a definitive screening level approach because since that time the Agency has engaged in a series of revisions to its Standard Operating Procedures (SOPs) for Residential Exposure Assessments (i.e., latest on February 22, 2001). Incorporating the revisions to the SOPs would only refine the exposure estimates (i.e., in all cases MOEs would be higher).

For the residential assessment, existing uses on turf, in gardens, on golf courses, and for structural pest control were considered, but a quantitative calculation was only completed for postapplication exposure on treated turf because this scenario is expected to have the highest associated exposures (i.e., this scenario was used as a screening level tool for all residential exposures).

The Agency used a screening level approach to address the risks associated with the use of the aerosol can product of lambda-cyhalothrin that can be purchased and used by homeowners. In this case, a screening level quantitative calculation was only completed for postapplication exposure on treated turf because this scenario is expected to have the highest associated exposures of all residential exposures. In other words, this is a lower tier approach and EPA believes that the selected postapplication assessment on lawns for children is protective for all residential exposures (even the aerosol can handler scenario) because the dose levels for children playing on treated lawns are thought to exceed those expected for all other scenarios (i.e., lawn exposures for children represents the worst case scenario). This approach is based on the following considerations:

• For children on lawns, there was no dissipation of residues from the treated lawn since it was assumed that exposure was determined immediately after application of the lawn product.

• For children on lawns, dermal exposure was high because it was based on a jazzercise scenario which involves a high duration of exposure on the lawn and an intensity of activity that results in a high degree of contact with the treated lawn.

• Low application rate is expected for residential handler.

• Postapplication oral exposure to children on lawns was also calculated which resulted in acceptable MOEs (aggregate MOE = 500), this approach is thought to provide conservative estimates of exposure and it is not a route of consideration for adult handlers.

All residential (non-occupational) MOEs calculated using this screening level approach were well above the Agency target MOE of 100.

The Agency uses the term postapplication to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. Lambda-cyhalothrin can be used in many areas that can be frequented by the general population including residential areas such as lawns. As a result, individuals can be exposed by entering these areas if they have been previously treated.

The postapplication assessment for treatment on lawns is based on a screening level approach in which children's and adult's exposure from treated turf were selected to represent the highest anticipated exposure scenarios. In this case, the Agency believes that exposures associated with contact to treated turf represent the high exposure scenario. Adults and children of varying ages can potentially be exposed by dermal and inhalation routes of exposure when they contact previously treated turf. Children may also be exposed by incidental non-dietary ingestion of turf. Each of these elements was considered in the calculation of postapplication exposure for lambda-cyhalothrin on turf. The residential MOEs were aggregated together because, regardless of the exposure route (dermal, inhalation or oral), lambda-cyhalothrin has similar adverse effects (i.e. neurotoxicity).

All residential (non-occupational) MOEs calculated using this screening level approach were well above the Agency target MOE of 100 for the inhalation, dermal, and oral routes and therefore do not exceed EPA's level of concern (range 700 to 14,700). Additionally, when total MOEs were calculated (i.e., each routes added together), MOEs still were not of concern (MOEs for children = 500 and for adults = 3,000).

A quantitative postapplication risk assessment for termiticide use was not performed for this use. Since the IMPASSE TM Barrier is placed under the foundation (poured concrete) of houses the potential for dermal exposure is negligible. The potential for postapplication inhalation exposure is also expected to be extremely minimal. Furthermore, the vapor pressure for lambda-cyhalothrin is very low (1.5 x 10 -9 mmHg) and therefore EPA does not anticipate any significant air concentrations accumulating of lambda-cyhalothrin.

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 lambda-cyhalothrin 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, lambda-cyhalothrin 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 lambda-cyhalothrin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a 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 . Through the use of bridging data, the toxicology database for lambda-cyhalothrin has been completed using developmental, reproduction, chronic (rodent) and oncogenicity studies conducted with cyhalothrin. With the exception of the developmental neurotoxicity study, the toxicology database for lambda-cyhalothrin, when bridged with cyhalothrin, is complete and there are no data gaps. The scientific quality is relatively high and the toxicity profile of lambda-cyhalothrin can be characterized for all effects, including potential developmental, reproductive and neurotoxic effects. The data provided no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to cyhalothrin. The requirement for developmental studies conducted with lambda-cyhalothrin have been satisfied with developmental studies conducted with cyhalothrin. The data demonstrate no indication of increased quantitative or qualitative sensitivity of rats or rabbits to in utero exposure to cyhalothrin. No developmental toxicity was observed in either of the developmental toxicity studies in rats and rabbits. Maternal toxicity was observed in the form of clinical signs of neurotoxicity and reduced body weight gain and food consumption in the rat study and reduced body weight gain and food consumption in the rabbit study. In the 3-generation reproduction study in rats, the parental/offspring NOAELs are the same based on decreased parental and pup body weight and body weight gain.

3. Conclusion . The cyhalothrins induce clinical signs of neurotoxicity in at least three species (rats, mice and dogs), and a developmental neurotoxicity (DNT) study has been required. A subchronic neurotoxicity study has recently been submitted but has not yet been reviewed; a preliminary review found that the NOAELs are higher than endpoints selected by EPA and this study is not expected to change conclusions of this risk assessment.

EPA has required that a DNT be conducted for lambda-cyhalothrin based upon structure activity relationship (SAR), mode of action, and toxicity information that identifies cyhalothrin and lambda-cyhalothrin as neurotoxic pesticides. Developmental neurotoxicity testing with cyhalothrin is required, to further characterize the potential hazard to the developing animal, in accordance with standard OPP guidance. This determination was based upon a weight-of-evidence evaluation of the database, conducted in accordance with principles first developed at a 1989 Agency workshop on quantitative and qualitative comparability of human and animal developmental neurotoxicity (Levine, T.E and R.E. Butcher (1990) Triggers for developmental neurotoxicity testing. Neurotoxicology and Teratology 12:281-284.), and which have been subsequently reviewed by the FIFRA Scientific Advisory Panel in connection with DNT guideline development (1989), the retrospective analysis of DNT studies submitted to OPPTS (December, 1998), and FQPA 10X guidance (May, 1999).

Although a DNT has been required, EPA evaluated whether the existing reliable toxicity data for lambda-cyhalothrin provided EPA with the confidence to make a safety finding for infants and children using a different safety factor than the default additional safety factor of 10X. For the reasons set forth, EPA has concluded that existing, reliable toxicity data provide reasonable certainty that a risk assessment conducted using no additional factor (1X) will protect the safety of infants and children. First, it is noted that there was no indication, in the developmental or reproductive toxicity studies or in any published literature studies, of increased sensitivity in the offspring of rats or rabbits to in utero and/or postnatal exposure to cyhalothrin. Since there is no evidence that immature animals respond more severely than adults to cyhalothrin exposure in these studies, there is less concern regarding the potential for increased sensitivity in a developmental neurotoxicity study.

Second, an extensive evaluation of the data base for the cyhalothrins revealed that no damage to the neurological system (i.e., microscopic lesions, commonly referred to as “neuropathology”) was observed in the brain of rats or dogs following subchronic or chronic exposure and with formalin fixation of tissues. Even more importantly, in the acute neurotoxicity study with lambda-cyhalothrin, both central and peripheral nervous system tissues were examined following in situ perfusion fixation of tissues (which reduces microscopic artifacts that can result during processing). As per guideline recommendations, this included more extensive sampling and microscopic evaluation of these tissues than is required in standard subchronic or chronic studies. Even with this expanded examination, no treatment-related lesions were observed in the central and peripheral nervous system. (The subchronic neurotoxicity study with lambda-cyhalothrin is currently under review by EPA and was not available at the time of the prior EPA review; however, preliminary evaluation of the neuropathology data by EPA scientists did not reveal the presence of treatment-related lesions.) These findings demonstrate that lambda-cyhalothrin does not alter nervous system structure in adult rats, even at the microscopic level. Additionally, there was no evidence from the prenatal developmental toxicity studies (in rats and rabbits) and the two-generation reproduction study in rats, of malformations or variations of the central nervous system in offspring following in utero and/or postnatal exposures. Further, the generally accepted mechanism of action for pyrethroids, sodium channel disruption, has not been traditionally associated with developmental neuropathology. Together with the apparent lack of structural alterations in the nervous system of either adult or developing animals, this line of evidence leads to reduced concern regarding the potential that such effects would be observed in guideline developmental neurotoxicity testing.

Another critical factor in the database that supports EPA's determination that a safety finding can be made without use of an additional safety factor are the data bearing on the level at which neurotoxic effects and non-neurotoxic effects are observed in the rat (the animal used in performing DNTs) and the data pertaining to the level at which neurotoxic effects occur in dogs. While the precise outcome of a DNT study with lambda-cyhalothrin cannot be known prior to completion of the study, the existing toxicity data provide important information on whether any information is likely to emerge from the lambda-cyhalothrin DNT that would change the dose level used in estimating safe exposure levels to lambda-cyhalothrin in the lambda-cyhalothrin risk assessment. Based upon common principles of dose-setting, which utilize data from less complicated studies to inform the design of more complicated studies, it is highly probable that dietary dose levels for the DNT study will be based upon toxicity observed in the reproduction study in rats, considered in context of the complete toxicology database. In the reproduction study, parental and offspring effects consisted solely of body weight and body weight gain reductions at a dietary level of 100 ppm (approximately 5.0 mg/kg/day), and a NOAEL was established at 30 ppm (approximately 1.5 mg/kg/day) which was the mid-dose level on that study. Neurotoxicity effects have only been seen in the rat at significantly higher doses (acute oral neurotoxicity study having a NOAEL of 10 mg/kg/day and a LOAEL of 35 mg/kg/day). In the dog, neurotoxic effects have been found at lower levels (NOAEL of 0.5 mg/kg/day) than the non-neurotoxic effects seen in the rat reproductive study. What this indicates is that the DNT will likely be conducted at dose levels significantly lower than at which any neurotoxic effects have previously been seen in the rat but still significantly greater than the levels used for assessing acute and chronic risk. Thus, the results from the DNT, even if they show sensitivity in the rat young (which would not be expected), are unlikely to change the levels used for assessing chronic and acute risk.

No quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure in the developmental studies was observed. No developmental toxicity was observed in either of these studies. No quantitative or qualitative evidence of increased susceptibility was observed in the 3-generation reproduction study in rats. Offspring toxicity (decreased pup weight and pup weight gain) was observed in the reproduction study at the same dose level as parental toxicity (decreased body weight and body weight gain). These effects are not considered to be more severe than the effects in the parents. There are no residual uncertainties for pre- and/or post-natal toxicity in any of the available studies with Cyhalothrin.

This information supports the dose analysis conducted by EPA as well as the removal of the special Food Quality Protection Act (FQPA) Safety Factor required for the protection of infants and children. Therefore, the FQPA Safety Factor (as discussed in the February 2002 OPP 10X guidance document) was reduced to 1X.

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to lambda-cyhalothrin will occupy 41% of the aPAD for the U.S. population, 24% of the aPAD for females 13 years and older, 71% of the aPAD for all infants ( < year old) and 82% of the aPAD for children 1-6 years old. In addition, there is potential for acute dietary exposure to lambda-cyhalothrin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to lambda-cyhalothrin from food will utilize 8% of the cPAD for the U.S. population, 12% of the cPAD for all infants ( < 1 year old) and 22% of the cPAD for children 1-6 years old. Based on current use patterns, chronic residential exposure to residues of lambda-cyhalothrin is not expected. In addition, there is potential for chronic dietary exposure to lambda-cyhalothrin 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 4:

3. Short- and Intermediate-term risk . Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Lambda-cyhalothrin is currently registered for use that could result in short- and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short- and intermediate-term exposures for lambda-cyhalothrin.

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

5. Aggregate cancer risk for U.S. population . The database for carcinogenicity is considered complete, no additional studies are required at this time. The requirements for carcinogenicity studies in the rat and the mouse with lambda-cyhalothrin have been satisfied by a combined chronic/carcinogenicity study in rats and a carcinogenicity study in mice, both conducted with cyhalothrin. Although mice should have been tested at a higher dose, it was determined that there was not enough toxicological concern to warrant a requirement for a new carcinogenicity study in mice. Lambda-cyhalothrin is classified as a Group D chemical (not classifiable as to human carcinogenicity).

Under the conditions of the studies, lambda-cyhalothrin is not considered to be carcinogenic in either rats or mice. However, there has been a question concerning a slight but not statistically significant increase in mammary tumors in the mouse study. In that study, the dose levels were not sufficiently high to totally rule these out. Nevertheless, it is determined that there is not a sufficient toxicological concern to ask for a new study for the following reasons: an examination of the evidence of carcinogenicity with other pyrethroids showed no increases in mammary tumors with any other pyrethroid. In addition, from a mode of action standpoint, the primary effect of the pyrethroids is on the neuromuscular system. Pyrethroids generally stimulate nerve cells to produce repetitive discharges which are caused by their action on the sodium channel. Mammary gland carcinogenesis in the rodent can be caused by either mutagenesis or by a hormonal imbalance leading to elevated or prolonged exposure to estrogen. There is no evidence that the pyrethroid mode of action leads to a hormonal imbalance and lambda-cyhalothrin has not been shown to be a DNA reactive mutagen. For these reasons, it is unlikely that a repeat mouse study on lambda-cyhalothrin would provide any additional evidence. Therefore, a risk assessment for potential carcinogenicity to humans is not required.

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 lambda-cyhalothrin residues.

Adequate enforcement methods are available for determination of lambda-cyhalothrin residues in plant and animal commodities. ICI Method 81 (PRAM 81) is used to determine the residues of lambda-cyhalothrin and its epimer in plant matrices and ICI Method 86 is used to determine residues of lambda-cyhalothrin and its epimer in animal matrices. Both methods have been validated by EPA as adequate enforcement methods for determination of parent lambda-cyhalothrin and its epimer in the respective matrices. ICI Method 96 is used to determine lambda-cyhalothrin metabolites in meat, milk, poultry and eggs. The LOQ for all three methods is 0.01 ppm.

There are currently no Mexican, Canadian or Codex maximum residue limits (MRLs) for lambda-cyhalothrin. There are MRLs for cyhalothrin from which lambda-cyhalothrin is derived as an enriched isomer.

Residue field trial data are adequate to support the established and proposed lambda-cyhalothrin tolerances. The Monte Carlo methods for acute dietary analyses for cattle (beef and dairy) to select the feed items comprising the potential cattle diets and associated residues have been previously reviewed and found acceptable. The nature of the residues of lambda-cyhalothrin in plants and animals is understood. Quantifiable residues are expected on most treated commodities.

Therefore, the tolerance is established for residues of lambda-cyhalothrin, in or on almond, hulls at 1.5 ppm; apple pomace, wet at 2.50 ppm; avocados (imported) at 0.20 ppm; canola, seed at 0.15 ppm; fruit, pome, group at 0.3 ppm; fruit, stone, group at 0.50 ppm; nut, tree, group at 0.05 ppm; peanut, hay at 3.0 ppm; peas and beans - dried shelled, (except soybean), subgroup at 0.1 ppm ; peas and beans - succulent shelled, subgroup at 0.01 ppm; sorghum, grain, forage at 0.3 ppm; sorghum, grain, stover at 0.5 ppm; sugarcane at 0.05 ppm; vegetables, fruiting, group (except cucurbits) at 0.2 ppm; and vegetables, legumes, edible podded subgroup at 0.2 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-2002-0204 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0204 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 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-2002-0221. 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 21, 2002 (67 FR 54192) (FRL-7191-1), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of pesticide petitions (PP 0E6178, 2E6386, 2E6410, 2E6432) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. This notice included a summary of the petitions prepared by BASF Corporation, Research Triangle Park, NC., the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.493 be amended by establishing tolerances for residues of the fungicide dimethomorph, [[(E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine]], in or on the following food commodities:

1. PP 0E6178 proposed a tolerance for hop, dried cones at 60 ppm. This tolerance replaces the existing tolerance for hops, cones, dried at 60 ppm. There were no U.S. registrations for use of dimethomorph on hops when the existing tolerance was established. IR-4 provided magnitude of residue studies and has requested a new tolerance for hop, dried cones at 60 ppm in support of U.S. registration for hops.

2. PP 2E6386 proposed a tolerance for lettuce, leaf and lettuce, head at 10 ppm.

3. PP 2E6410 proposed a tolerance for vegetable, cucurbit, group at 0.5 ppm.

4. PP 2E6432 proposed a tolerance for vegetable, bulb, group at 2.0 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 dimethomorph on hop, dried cones at 60 ppm; lettuce, leaf and lettuce, head at 10 ppm; vegetable, cucurbit, group at 0.5 ppm; and vegetable, bulb, group at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follows.

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

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

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

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

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

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.493) for the residues of dimethomorph, in or on grape at 3.5 ppm; hops, cones, dried at 60 ppm; raisins at 6.0 ppm; potato at 0.05 ppm; potato, wet peel at 0.15 ppm; tomato at 0.5 ppm and tomato, paste at 1.0 ppm. There were no U.S. registrations for grape, hop, or raisins at the time the tolerances were established for these food commodities. Time-limited tolerances are established for residues of dimethomorph in or on cantaloupe, cucumber, squash, and watermelon at 1.0 ppm in connection with the use of the pesticide under section 18 emergency exemptions. Risk assessments were conducted by EPA to assess dietary exposures from dimethomorph in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. An acute exposure assessment was not performed since no effects attributable to a single exposure (dose) were observed from oral toxicity studies.

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 chronic exposure assessment is based on very conservative assumptions that all commodities that have tolerances for dimethomorph and the commodities included in this action will contain residues (100 percent crop treated) at the tolerance level.

iii. Cancer . A cancer exposure assessment was not performed since dimethomorph is classified as Not Likely to be a human carcinogen.

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow 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 screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would exceed human health levels of concern.

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

Based on the FIRST and SCI-GROW models the EECs of dimethomorph for chronic exposures are estimated to be 28.5 ppb parts per billion (ppb) for surface water and 0.30 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Dimethomorph is not registered for use on any sites that would result in residential exposure.

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

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

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

2. Prenatal and postnatal sensitivity . The developmental and reproductive toxicity data did not indicate increased susceptibility of rats or rabbits to in utero and/or postnatal exposure.

3. Conclusion . There is a complete toxicity database for dimethomorph 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 reduced to 1X. The FQPA factor was reduced because:

i. The toxicology database is complete; the developmental and reproductive toxicity data did not indicate increased quantitative or qualitative susceptibility of rats or rabbits to in utero and/or postnatal exposure.

ii. A developmental neurotoxicity study is not required by the Agency. There is no evidence of neurotoxicity in the current toxicity database.

iii. The dietary (food and water) exposure assessment did not indicate a concern for potential risk to infants and children when tolerance level residues were used. The use of tolerance level residues results in an overestimate of dietary exposure.

iv. Residential exposure is not expected since dimethomorph is not registered for residential use.

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

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

1. Acute risk . An appropriate endpoint attributable to a single exposure for the general U.S. population (including infants and children) was not identified. An acute risk assessment was not performed, since no acute risk from dietary exposure is expected.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethomorph from food will utilize 5% of the cPAD for the U.S. population, 6% of the cPAD for infants less than 1 year old and 10% of the cPAD for children 1 to 6 years old, the subpopulation at greatest exposure. There are no residential uses that result in chronic residential exposure to dimethomorph. In addition, there is potential for chronic dietary exposure to dimethomorph in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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

4. Aggregate cancer risk for U.S. population . The Agency concludes that pesticidal uses of dimethomorph are not likely to pose a carcinogenic hazard to humans.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to dimethomorph residues.

An adequate method is available for enforcement of the tolerances. FAMS 002-02 is a high pressure liquid chromatography analytical method with ultraviolet detection and is adequate for determining residues of dimethomorph per se. The method has been successfully validated by the Agency's Analytical Laboratory. The method may be requested from: Paul Golden, U.S. EPA/OPP/BEAD/ACB, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone number: 410-305-2960; FAX 410-305-3091; e-mail address: RAM Mailbox.

There are no established or proposed maximum residue limits or tolerances for dimethomorph in or on hop, dried cones; lettuce, leaf; lettuce, head; vegetable, cucurbit, group; or vegetable, bulb, group.

Therefore, the tolerance is established for residues of dimethomorph, [(E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine]], in or on hop, dried cones at 60 ppm; lettuce, leaf and lettuce, head at 10 ppm; vegetable, cucurbit, group at 0.5 ppm; and vegetable, bulb, group 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-2002-0221 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0221, 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 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-2002-0195. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of May 3, 2000, 65 FR 2572, FRL-6555-9 and August 21, 2002, 67 FR 54200, (FRL-7191-6), EPA issued notices pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petition (PP 0F6115) by Elanco Animal Health, a Division of Eli Lilly and Company, 2001 W. Main St., Greenfield, IN 46140, and (PP 1E6321, 2E6354, 2E6370, 2E6384, 2E6400, and 2E6422) by the Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1, South, North Brunswick, NJ 08902-3390. These notices included summaries of the petitions prepared by Dow AgroScience LLC, Indianapolis, IN 46268, the registrant. There were no comments received in response to the notices of filing.

The petitions requested that 40 CFR 180.495 be amended by establishing tolerances for residues of the insecticide spinosad, in or on food commodities as follows:

1. PP 1E6321 proposed establishment of a tolerance for fig at 0.1 ppm,

2. PP 2E6354 proposed establishment of a tolerance for herbs subgroup at 8.0 ppm. The petition was revised to propose tolerances for the herb, fresh, subgroup at 3.0 ppm; and the herb, dried, subgroup at 22 ppm.

3. PP 2E6384 proposed establishment of tolerances for root vegetable subgroup at 0.10 ppm, and dry bulb onion at 0.1 ppm. The petition was revised to propose a tolerance for the vegetable, root and tuber, group at 0.10 ppm; and a separate tolerance for beet, sugar, molasses at 0.75 ppm.

4. PP 2E6400 proposed establishment of a tolerance for caneberry subgroup at 0.7 ppm,

5. PP 2E6422 proposed establishment of tolerances for grape at 0.6 ppm, grape juice at 1.2 ppm, and raisin at 0.6 ppm. The petition was amended to propose tolerances for grape at 0.50 ppm; and grape, raisin at 0.70 ppm. The Agency determined that a tolerance for grape juice is not needed.

6. PP 2E6370 proposed establishment of a tolerance for peanut at 0.02 ppm,

7. PP 0F6115 proposed to increase the established tolerances for cattle meat, meat byproducts, fat, milk and milk fat. The increased tolerances are needed in support of proposed registration for direct application to beef and dairy cattle for insect control. Tolerances were proposed for cattle, meat at 0.45 ppm; cattle, meat byproducts at 2.25 ppm; cattle, fat at 5.75 ppm; milk at 0.75 ppm; and milk, fat at 8.0 ppm. The petition was subsequently revised to propose tolerances for cattle, meat at 0.50 ppm; cattle meat byproducts at 2.0 ppm; cattle, fat at 6.5 ppm; milk at 2.5 ppm; and milk, fat at 27 ppm.

Existing tolerances under § 180.495(a) for beet, garden, roots at 0.10 ppm, beet, sugar, roots at 0.10 ppm, and tuberous and corm vegetables (crop group 1C) at 0.02 ppm are no longer needed and will be removed. They are replaced with the new tolerance for vegetable, root and tuber, group at 0.10 ppm. Existing tolerances for section 18 emergency exemption under §180.495(b) for beet, sugar at 0.020 ppm; beet, sugar, molasses at 0.25 ppm; peanut at 0.02 ppm; milk, whole at 2.0 ppm and milk, fat at 20.0 ppm are also not needed and will be removed. Tolerances established by this regulation under §180.495 (a) for the vegetable, root and tuber, group at 0.10 ppm; beet, sugar, molasses at 0.75 ppm; peanut at 0.02 ppm; milk at 2.5 ppm; and milk, fat at 27 ppm obviate the need for these section 18 emergency exemptions.

Spinosad is a fermentation product of Saccharopolyspora spinosa. The product consists of two related active ingredients: Spinosyn A (Factor A; CAS No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-″N-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11, 12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-″N-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a, 16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. Typically, the two factors are present at an 85:15 (A:D) ratio.

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 spinosad on fig at 0.10 ppm; herb, fresh, subgroup at 3.0 ppm; herb, dried, subgroup at 22 ppm; vegetable, root and tuber, group at 0.10 ppm; caneberry subgroup at 0.7 0 ppm; grape at 0.50 ppm; grape, raisin at 0.70 ppm; peanut at 0.02 ppm; beet, sugar, molasses at 0.75 ppm; cattle, meat at 0.50 ppm; cattle, meat byproducts at 2.0 ppm; cattle, fat at 6.5 ppm; milk at 2.5 ppm and milk, fat at 27 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follows.

EPA has evaluated the available toxicity data and considered their 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 spinosad are discussed in the following Table 1 as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

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

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

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

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

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.495) for the residues of spinosad, in or on a variety of raw agricultural commodities. Spinosad is registered for use on a large number of agricultural commodities. Due to Section 18 emergency exemption use for control of Mediterranean fruit fly, tolerances for residues of spinosad have been established at 0.02 ppm for all agricultural commodities not covered by other pesticide tolerances. Risk assessments were conducted by EPA to assess dietary exposures from spinosad in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. 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 . Spinosad chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model (DEEM  TM ) software Version 7.76, which incorporates consumption data from USDA's 1989-1992- nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The chronic dietary (food only) analysis represents a moderately refined estimate of dietary exposure to spinosad due to the use of default processing factors, percent crop treated estimates for commodities having previously registered uses, and anticipated residues for meat and milk.

iii. Cancer . Spinosad has been classified as “not likely to be carcinogenic in humans” based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. Therefore, a cancer risk assessment was not performed.

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

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

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

Almond 5 %; apple 28%; apricot 5%; avocado 5%, bean, snap 9%; broccoli 62%; cabbage 32%; cauliflower 54%; celery 78%; collards 24%; cherry 5%; eggplant 14%; grapefruit 1%; grape, wine 1%; kale 32%; lemon 11%; lettuce, head 59%; Lettuce, other 42%; mustard greens 17%; orange 6%; peach 4%; pepper 45%; pistachio 1%; prune/plum 5%; spinach 32%; pumpkin 1%; squash 1%; sweet corn 1%; tangerine 6%; turnip, greens 6%; tomato, fresh 30%; tomato, processed 2%; watermelon 1%; cotton 3%; dry bean/pea 1%; peanut 1%; potato 1%; wheat, winter 1%.

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

2. Dietary exposure from drinking water . Spinosad and its degradates are not very persistent and are relatively immobile. The potential for its residues to leach to groundwater and runoff to surface water is very low. Spinosad (containing Factors A and D) is expected to dissipate rapidly in the environment with a low potential to leach or runoff to surface water. Slow metabolic degradation was observed only in flooded sediment (half-lives 161-250 days in the laboratory, > 25 days outdoors). Transformation products (Factor B and N-demethyl spinosad Factor D) are persistent (half-lives > 6 months) in aerobic soil metabolism studies, but are relatively immobile.

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow 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 screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would exceed human health levels of concern.

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

Based on the First and SCI-GROW models the estimated environmental concentrations (EECs) of spinosad for chronic exposures is estimated to be 2.3 parts per billion (ppb) for surface water and 0.037 ppb for ground water. The EECs for spinosad are based on application of the insecticide to turf at a maximum of four applications at a rate of 0.41 pound active per acre per application.

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). Spinosad is currently registered for use on residential turf and ornamentals to control a variety of insect pests. The registered residential products for spinosad are Conserve SC Turf and Ornamental (EPA Reg No. 62719-291) and Conserve Fire Ant Bait (EPA Reg No. 62719-304).

Conserve Fire Ant Bait is a ready-to-use granular formulation that may be applied by homeowners. For adults, residential exposures may result from dermal and inhalation exposure while applying Conserve Fire Ant Bait and/or from dermal contact with treated turf. However, dermal post-application exposure is not of concern since no toxicological endpoint was established for dermal exposure. Inhalation exposure is not expected due to the low vapor pressure of spinosad and because the homeowner product is formulated as a granular. Post-application exposure to toddlers was not assessed for the Conserve Fire Ant Bait product since children are not likely to “habit” lawn areas where fire ant mounds are present.

Conserve SC is labeled for use on turfgrass and ornamentals by commercial applicators. Since this product will be applied by commercial applicators, homeowner applicator exposure was not assessed. For toddlers, dermal and non-dietary oral post-application exposures may result from dermal contact with treated turf as well as hand-to-mouth transfer of residues from turfgrass. Since dermal post-application exposure is not of concern, only hand-to-mouth, object-to-mouth and incidential ingestion of soil exposures for the turf and ornamental uses were performed. The average aerobic soil metabolism half-life of spinosad (containing factors A and D) is 13-14 days. For the intermediate-term duration, typical lawn maintenance practices, such as mowing and watering, are expected to expedite the dissipation of spinosad on turfgrass. Since residue on turf that is available for transfer after day 30 is expected to be negligible, intermediate-term post-application incidental oral exposures were not assessed.

The Agency developed exposure formulas and estimated doses to theoretically assess residential post-application incidental oral exposure scenarios including: (1) Hand-to-mouth, (2) object-to-mouth (turfgrass), and (3) incidental ingestion of soil. The resulting incidental oral ingestion MOEs from residential use of spinosad on turf are as follow:

• MOE for oral hand-to-mouth activities on treated lawns is 800 for short-term (1-30 days).

• MOE for oral object-to-mouth (turfgrass) from treated lawns is 3300 for short-term.

• MOE for incidental ingestion of soil from treated lawns is 240,000 for short-term.

• Combined Incidental Oral MOE (hand-to-mouth, object-to-mouth, and soil ingestion) is 640. All MOEs are below EPA's level of concern.

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 spinosad 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, spinosad 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 spinosad 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 . There is no indication of increased susceptibility of rat and rabbit fetuses to in utero and/or postnatal exposure.

3. Conclusion . There is a complete toxicity data base for spinosad 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. This recommendation is based on:

i. There is no evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure in the developmental studies with spinosad, and there is no evidence of increased susceptibility of young rats in the reproduction study with spinosad;

ii. There are no residual uncertainties identified in the exposure databases; the dietary food exposure assessment (chronic only; no acute endpoint was identified) is refined using Anticipated Residues calculated from field trial data and available percent crop treated information (100% crop treated is assumed for proposed new uses) and,

iii. The dietary drinking water exposure is based on conservative modeling estimates,

iv. OPP's Health Effect Division Residential Standard Operating Procedures were used to assess post-application exposure to children as well as incidental oral exposure of toddlers, so these assessments do not underestimate the exposure and risks posed by spinosad,

v. A developmental toxicity study is not required.

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). DWLOCS 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 DWLOCS, 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 DWLOCS.

A DWLOCS 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 DWLOCS is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

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

1. Acute risk . Acute aggregate risk consists of the combined dietary exposures from food and drinking water sources. The total exposure is compared to the acute RfD. An acute RfD was not identified since no effects were observed in oral toxicity studies that could be attributable to a single dose. Therefore, the Agency concludes that there is a reasonable certainty of no harm from acute aggregate exposure to spinosad.

2. Chronic risk . Using the exposure assumptions described in unit C for chronic exposure, EPA has concluded that exposure to spinosad from food will utilize 30% of the cPAD for the U.S. population, 41% of the cPAD for infant < 1 year old and 69% of the cPAD for children 1-6 years old (subpopulation at greatest exposure). Based the use pattern, chronic residential exposure to residues of spinosad is not expected. In addition, there is potential for chronic dietary exposure to spinosad in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

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

Spinosad 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 spinosad.

Using the exposure assumptions described in unit C for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 600 for the U.S. Population, 260 for all infants < 1 year old, 190 for children 1-6 years old (greatest risk subpopulation) and 250 for children 7-12 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of spinosad 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 in the following Table 4:

4. Aggregate cancer risk for U.S. population . Spinosad has been classified as “not likely to be carcinogenic in humans” based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. Therefore, spinosad is not expected to pose a cancer risk to humans.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to spinosad residues.

Adequate enforcement methodology using high pressure liquid chromatography with ultraviolet detector (HPLC/UV) is available to enforce the tolerances in plants. Adequate livestock methods are available for tolerance enforcement. Method RES 94094 (GRM 95.03) is an HPLC/UV method suitable for determination of spinosad residues in ruminant commodities. Method GRM 95.03 has undergone successful independent laboratory validation (ILV) and EPA laboratory validation, and has been forwarded to FDA for inclusion in PAM Volume II. Method GRM 95.15 is another HPLC/UV method suitable for determination of spinosad residues in poultry commodities. This method has been forwarded to FDA for inclusion in PAM Volume II. Method RES 95114, an immunoassay method for determination of spinosad residues in ruminant commodities, underwent a successful ILV and EPA laboratory validation. It has been submitted to FDA for inclusion in PAM Volume II. The methods may be requested from: Paul Golden, US EPA/OPP/BEAD/ACB, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone number: (410) 305-2960; FAX (410) 305-3091; e-mail address: RAM Mailbox.

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been established for residues of spinosad on the caneberry subgroup, root and tuber vegetables, the herb subgroup, fig, grape, peanut, or livestock commodities.

Therefore, tolerances are established for residues of spinosad, in or on fig at 0.10 ppm; herbs, fresh, subgroup at 3.0 ppm; herbs, dried, subgroup at 22 ppm; vegetable, root and tuber, group at 0.10 ppm; caneberry subgroup at 0.70 ppm; grape at 0.50 ppm; grape, raisin at 0.70 ppm; peanut at 0.02 ppm; beet, sugar, molasses at 0.75 ppm; cattle, meat at 0.50 ppm; cattle, meat byproducts at 2.0 ppm; cattle, fat at 6.5 ppm, milk at 2.5; and milk, fat at 27 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-2002-0195 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit 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-2002-0195, 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 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 homp 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-2002-0232. 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 (FR 67 18894) (FRL-6830-5), 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 0F06130, 0F06195, and 0F06273) by Monsanto, 600 13th St., NW., Suite 660, Washington, DC 20005. The notice included a summary of the petition prepared by Monsanto, the registrant. Comments received in the public docket with respect to the Notice of Filing Pesticide Petitions to Establish a Tolerance for Glyphosate in or on Food (April 17, 2002, 67 FR 18894) are discussed in the section below.

The Northwest Coalition for Alternatives to Pesticides (NCAP) researches and cites studies that are not included in corporate evaluations of their products, and summarizes them in the Journal of Pesticide Reform. The following comments submitted to the Agency by Jill Davies/RiverCare, Martha T. Franks/Taylor Farms and Jeff Schahczenski/Executive Director/Western Sustainable Agriculture Working Group cite the opinions of the NCAP concerning the information contained within the April 17, 2002 Federal Register for glyphosate.

The Notice states:

Comment: The metabolite AMPA is of toxicological concern. In subchronic (midterm) tests on rats, AMPA caused an increase in the activity of an enzyme, lactic dehydrogenase, in both sexes; a decrease in liver weights in males at all doses tested; and excessive cell division in the lining of the urinary bladder in both sexes.

Agency response . The subchronic toxicity of AMPA has been investigated in rats and dogs. Treatment-related effects, such as urinary tract irritation, were observed in rats only at very high dosage levels. Gross and histopathologic examinations of these animals did not reveal effects in any other organ. No toxicities occurred in dogs at any dosage level tested. Based on these results, the Agency concluded that the metabolite of glyphosate, AMPA, is not of toxicological concern because the effects observed in subchronic toxicity studies cited above were: (1) Not dose-related, and/or (2) not considered biologically significant.

Comment: The mode of action of the residue in plants is not adequately understood. It is known that glyphosate is a systemic and non-selective herbicide that kills grasses, sedges, and broad-leaved plants, but exactly how it works is not well understood.

Agency response . Residue chemistry/plant metabolism studies for pesticidal active ingredients are not designed to determine the mode-of-action in plants, but instead are designed to determine the metabolic fate, including the identification of plant metabolites of the active ingredient, when it is systemically present in plants.

Although not relevant to nature of the residue studies, the primary mode of action for glyphosate is well understood and documented. Glyphosate is a member of the phosphono amino acid class of chemicals. These compounds are foliar-applied herbicides that interfere with normal plant amino acid synthesis, resulting in the inhibition of nucleic acid metabolism and protein synthesis. Specifically, glyphosate blocks the activity of 5-enolpyruvylshikimate 3-phosphate synthase (EPSP synthase), an enzyme that is involved in aromatic amino acid biosynthesis (essential for growth) and produced only by green plants. This pathway does not occur in animals, which must eat plants to obtain these essential amino acids. Consequently, glyphosate is toxic to all green plants and essentially nontoxic to other living organisms.

The Notice states:

Comment: This is correct, and Toxicity Category III means caution. But most toxicology studies are conducted using glyphosate alone, not the formulations that are in commercial products, which contain so-called inert ingredients. Roundup, which contains glyphosate and the surfactant POEA, is three times as acutely toxic to rats as glyphosate alone. This deficiency in regulation needs to be corrected.

Agency response . This action establishes a tolerance for glyphosate, not the inert polyethylated tallow amines (POEA). POEA is regulated separately under FFDCA and has been approved by the Agency. Additionally, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. , registration process, EPA evaluates the potential risks posed by inert ingredients such as the POEA. The Agency requires a full disclosure of inert ingredients for each Roundup formulation to determine acute toxicity such as acute oral, eye, skin, inhalation, and dermal sensitization. The combined effects of active and inert ingredients on a product's acute toxicity properties are reviewed by the Agency and used to define the appropriate personal protective equipment (PPE) and precautionary statements for each pesticide end-use product label that will provide adequate protection to users.

2. Genotoxicity (mutagencicty) — Comment: The FR Notice describes assays showing that glyphosate does not cause genetic damage, but other studies have shown that both glyphosate and its commercial products are mutagenic, and the commercial products are more potent mutagens than glyphosate.

Agency response . The mutagenicity studies referred to by the commenters is the Journal of Pesticide Reform (JPR), a magazine produced by the Northwest Coalition for Alternatives to Pesticides (NCAP) based in Eugene, OR. JPR has compiled and updated fact sheets on a number of pest-control products, including glyphosate (the active ingredient in Roundup agricultural herbicides).

Based on the negative responses observed in well validated assays conducted according to the required test guidelines and in compliance with USEPA Good Laboratory Practice Standards, the Agency concluded that the active ingredient pesticide, glyphosate, is neither mutagenic or clastogenic.

Several studies have tested herbicide formulations, including Roundup, for mutagenic/genotoxic potential. Although positive responses have been reported, the testing systems used in the cited studies may not be adequate for regulatory purposes for one or more of the following reasons: (1) Un-validated test systems that do not have established predictability based on broad experience using substances of known positive and negative genotoxicity/mutagenicity; (2) undocumented and uncharacterized test materials; (3) administered doses that cannot be correlated to expected exposures; (4) routes of exposure that vary from the required test protocols; (5) results that address endpoints which do not have a clear accepted relationship to human disease; and/or (6) deficient methodologies.

3. Reproductive and developmental toxicity — Comment: A study in Ontario found that father's (mostly farmers) use of glyphosate was associated with an increase in miscarriages and premature births in farm families. Laboratory studies on rats and rabbits have also demonstrated a number of effects from glyphosate on reproduction.

Agency response . Data from studies conducted according to accepted testing methods and reviewed by the Agency, demonstrate that glyphosate is not a reproductive or developmental toxicant. Glyphosate was evaluated in two multigenerational rat reproduction studies and developmental toxicity studies in rats and rabbits. Results from these studies did not indicate any adverse effects on the animals' ability to mate, conceive, carry or deliver normal offspring. Based on the findings from developmental toxicity studies in rats and rabbits, it can be concluded that glyphosate does not produce birth defects and developmental toxicity is only seen at maternally toxic doses.

The developmental toxicity of the surfactant POEA has been evaluated and found not to be a teratogen or a developmental toxicant in rats. Subchronic toxicity studies with the surfactant and/or Roundup herbicide have also been conducted in rats, rabbits, and dogs. In these studies, gross and microscopic pathology examinations were conducted on several reproductive tissues including ovaries, uterus, testes, and epididymis. No developmental effects or changes in reproductive tissues were found in any of these evaluations. There is no evidence that the surfactant or Roundup herbicide adversely impacts reproductive function.

4. Subchronic (medium-term) and chronic (long-term) toxicity studies on rats and mice — Comment . Once again, studies (both subchronic and chronic) other than those cited by Monsanto reflect toxicity from glyphosate, and commercial products are more toxic than just glyphosate.

Agency response . The Agency has determined that the existing data base for glyphosate is adequate according to testing guideline requirements for a food-use registration. There is high confidence in the quality of the existing studies and the reliability of the toxicity endpoints identified for use in risk assessments; there are no data gaps. Based on evaluation of the existing glyphosate data base, the Agency has concluded that the use of glyphosate and glyphosate products do not pose unreasonable risks or adverse effects to humans.

The potential toxicity of POEA has been assessed in subchronic oral studies with rats and dogs. Roundup herbicide has also been evaluated for possible subchronic effects in an inhalation study with rats, a dermal study in rabbits, and an oral study with cattle. It was anticipated most observed effects would be related to the surface-active properties and associated irritation potential of surfactants. These studies confirm that irritation at the site of contact was the primary finding with the test material. In the oral studies conducted with POEA and Roundup, effects secondary to gastrointestinal irritation (emesis and diarrhea) were noted; decreased food consumption and decreased body weight gain. However, these effects were not dose-related in rats and dogs. In the study conducted with cattle in which slight decreases in body weight occurred, dosages of Roundup herbicide were 30 to 100 times greater than the dose typically applied to foliage for agricultural weed control purposes. There was no systemic toxicity in the inhalation and dermal studies conducted with Roundup. No indication of specific target organ toxicity was observed in any of the subchronic toxicity studies.

5. Animal metabolism . The Notice states:

Comment: This is not true. There are a multitude of established effects on animals, including humans, and the mode of action is not understood at all. Roundup kills beneficial insects (parasitoid wasps, lacewings, ladybugs) and other arthropods that are important in humus production and soil aeration, and affect growth and survival of earthworms. Acute toxicities for fish LC 50 , the lethal concentration killing 50% of a population of test animals) range from 2 ppm to 55 ppm and increase with increases in water temperature.

Agency response . Animal metabolism studies for pesticide active ingredients do not evaluate toxicological effects, but instead are designed to determine the fate of the molecule within a mammalian metabolic system. The animal metabolism data reviewed by the Agency for glyphosate are adequate and the qualitative nature of the residue in animals is understood.

Environmental consequences of pesticide use are considered in the FIFRA registration process. Based on the current toxicity data, application rates and observance of risk management measures for the active ingredient glyphosate, EPA has determined that the risks for birds, mammals, aquatic organisms, bees and invertebrates are minimal. Glyphosate is no more than slightly toxic to fish and wild birds, and practically non-toxic to aquatic invertebrate animals. There is a very low potential for the compound to build up in the tissues of aquatic invertebrates and other aquatic organisms such as fish. The Roundup formulation is moderately to slightly toxic to freshwater fish and aquatic invertebrate animals. Glyphosate is nontoxic to honeybees. This active ingredient pesticide as well as surfactants in the formulated products have no known effect on soil microorganisms. The reported contact lethal dose (LD 50 ) for earthworms in soil are greater than 5,000 parts per million (ppm) for both the glyphosate trimethylsulfonium salt and Roundup.

6. Cancer . Unit C.3.ii. of the Notice states:

Comment: This is false. A recent Swedish Study of hairy cell leukemia (HCL), a form of non-Hodgkin's lymphoma cancer, found that people who were occupationally exposed to glyphosate herbicides had a threefold higher risk of HCL. A similar study of people with non-Hodgkin's lymphoma found exposure to glyphosate was associated with an increase risk of about the same size.

Agency response . The commenters are referring to two epidemiology studies published by Sweden. This type of epidemiologic evaluation does not establish a definitive link to cancer. Furthermore, this information has limitations because it is based solely on unverified recollection of exposure to glyphosate-based herbicides.

The carcinogenic potential of glyphosate has been evaluated in acceptable studies conducted in rats and mice. In June of 1991, the Agency concluded, following a thorough review of all available toxicity data, that glyphosate should be classified in Category E--Evidence of Non-carcinogenicity in Humans. This cancer classification was based upon the observation of no treatment-related tumors at any dose level with glyphosate tested up to the limit in rats and up to dose levels higher than the limit dose in mice, and the lack of evidence of mutagenicity/genotoxicity for glyphosate.

1. Dietary exposure . Tolerances have been established (40 CFR 180.364) for the residues of glyphosate in or on a variety of food and feed commodities. The petitioner proposes to add potassium salt to this list of acceptable salt forms to which the tolerances apply, and to amend or add a number of new animal feed tolerances and one food tolerance. Tolerances are also established for animal organs that may be consumed by humans (kidney at 4.0 ppm and liver at 0.5 ppm), and for poultry meat at 0.1 ppm, eggs at 0.05 ppm, and poultry meat by-products at 1.0 ppm, based on animal-feeding studies and reasonable worst-case livestock diets.

The Notice states:

Comment: It is not clear what analysis this statement is referring to. In any case, raising the tolerances in feed should result in new meat tolerance studies being done.

Agency response . EPA has conducted an analysis of the reasonable worst-case livestock diets, which include the additional dietary burden from the glyphosate feed tolerances proposed in the FR Notice. Adequate animal feeding studies are available for glyphosate in cattle, swine, and poultry. Based on the existing and proposed tolerances, the total estimated dietary burden derived from treated feed commodities (including those genetically altered to be tolerant to glyphosate) would not result in meat, milk, or egg residues that exceed currently established food tolerances on these commodities.

2. Drinking water — Persistence in soil — Comment: Glyphosate is acknowledged to be extremely persistent in the soil under typical application conditions. AMPA (the primary metabolite) is even more persistent than glyphosate. Studies in eight states found that the half-life in soil (the time required for half of the original concentration of a compound to break down or dissipate) was between 119 and 958 days. AMPA has been found in lettuce and barley planted a year after glyphosate treatment.

Agency response . Based on studies conducted both in the laboratory and the field, the Agency has determined that glyphosate is readily degraded by soil microbes to AMPA which is subsequently degraded to CO2. Data from field dissipation trials from eight sites show that the median half-life (DT50) for glyphosate applied at maximum use rates was 13.9 days with a range of 2.6 (Texas) to 140.6 (Iowa). The reported half-lives from the field studies conducted in the coldest climates, i.e., Minnesota, New York, and Iowa were longest at 28.7, 127.8, and 140.6 days, respectively, indicating that the rate of glyphosate degradation is somewhat slower in cooler climates compared to milder ones. Further degradation of AMPA to CO2 occurs at a slower rate than the initial degradation of glyphosate. Because of the strong binding of both glyphosate and AMPA to soil particles, there is very little uptake into plants of either glyphosate or AMPA from soil, even right after application of glyphosate. AMPA was found in only trace levels in lettuce and barley planted a year after application of glyphosate to soil. AMPA has been determined to not be of toxicological concern.

3. Found in water . The Notice states:

Comment: This is a false assumption. Glyphosate can move into surface water when the soil particles to which it tends to bind are washed into streams or rivers. Glyphosate has been found in both ground and surface water, where it can be toxic to aquatic life for a time.

Agency response . The FR notice statement refers to behavior of glyphosate in soil and its potential for movement to ground water, not its movement into surface water. Glyphosate adsorbs strongly to soil particles, which limits its vertical movement in soil and makes contamination of ground water unlikely to occur.

Glyphosate can potentially occur in surface water from spray drift, runoff, soil particle movement, or by direct application, but at concentrations that are much lower than levels at which toxic effects to aquatic organisms may occur. The Agency has estimated glyphosate levels that could occur in surface water based on presently approved use patterns using computer-modeling methods. Based on toxicological data from acute and chronic tests on fish and other aquatic species, EPA has determined that the potential for environmental effects of glyphosate in surface water is minimal.

The Notice states:

Comment: The Agency had better get monitoring exposure data for drinking water, for both glyphosate and for AMPA.

Agency response . In November 1999, the EPA Office of Water issued a report titled “A Review of Contaminant Occurrence in Public Drinking Water Systems.” The data in the report is further discussed in the report “Occurrence Summary and Use Support Document for the Six-Year Review of National Primary Drinking Water Regulations” (draft report issued in March 2002). The study is an analysis to date of the occurrence of contaminants in public water systems (PWSs). State data bases of compliance-monitoring data from PWSs were the primary data sources for the analysis. Glyphosate monitoring data of both surface water and ground water sources for 7,800 PWSs were included in the analysis. Occurrences of detectable levels of glyphosate in ground water or surface water were very infrequent. All detections of glyphosate were below 10% of the Maximum Contaminant Level (MCL), which is the health-based maximum permissible level of a contaminant in water that is delivered to any user of a PWS. Only 0.1% of the PWSs reported any detection of glyphosate at a level above 1% of the MCL. These monitoring results are consistent with the modeling predictions discussed above, and reinforce the Agency's conclusion that aggregate exposure to glyphosate via all exposure routes, including drinking water, will not exceed the Agency's level of concern (100% of the cPAD).

4. Non-dietary exposure . The Notice states:

Comment: There are many toxicological concerns and in California, glyphosate exposure illness among agricultural and landscape workers is common with serious effects reported including blurred vision, peeling of skin, nausea, headache, vomiting, diarrhea, chest pain, dizziness, numbness. How does EPA define undue risks?

Agency response . Some glyphosate end-use products are assigned Toxicity Categories I and II for eye and dermal irritation because they contain POEA surfactants, which have been identified as eye and dermal irritants. For all such formulations, the Agency continues to recommend the addition of personal protective equipment (PPE) and precautionary statements appropriate for labeling of end-use products in Toxicity Categories I and II.

The Notice states:

Comment: When the mode of action is not clearly understood, even more uncertainty exists regarding synergistic effects with other substances. Rather than raising tolerances, EPA should be exercising the Precautionary Principle and lowering them.

Agency response . The herbicidal mode-of-action of glyphosate in plants is well-understood (see Unit A. Residue Chemistry, Agency response of this document) but is not relevant to the determination of whether it shares a common mechanism of toxicity with other substances. Glyphosate does not appear to produce a toxic metabolite that is also produced by other substances that could be grouped together for a cumulative risk assessment, thus at this time, EPA will not include glyphosate in such an assessment.

U.S. population and infants and children — Comment: The mode of action of glyphosate is not understood, synergistic effects are not understood, and a multitude of studies indicate that glyphosate is toxic in all standard categories of toxicological testing. Again, rather than raising tolerances, EPA should be exercising the Precautionary Principle and lowering them.

Agency response : The herbicidal mode-of-action of glyphosate in plants is well-understood (see the previous discussion above) but is not relevant to the determination of whether it shares a common mechanism of toxicity with other substances. Glyphosate does not appear to produce a toxic metabolite that is also produced by other substances that could be grouped together for a cumulative risk assessment, thus at this time, EPA will not include glyphosate in such an assessment. In evaluating these tolerance petitions, EPA has concluded that the proposed tolerances meet the FFDCA standard of reasonable certainty of no harm. This standard requires consideration of aggregate exposure to glyphosate from existing uses as well as exposure from the new uses proposed in the petitions before EPA. EPA requires that toxicological tests conducted with individual active ingredients using validated testing methods be submitted and reviewed in support of its registration decisions. Results from a complete data base of acceptable studies conducted with glyphosate have demonstrated that adverse effects will not occur at expected exposure levels. The Agency is not aware of scientific evidence that demonstrates enhanced potency of glyphosate's toxicological effects that arise through synergistic mechanisms.

Several maximum residue limits (MRLs) for glyphosate have been established by Codex in or on various commodities. The Codex MRL for rice grain is 0.1 ppm. The proposed rice grain tolerance of 15.0 ppm, is based on crop field trial data obtained using glyphosate-tolerant rice and therefore cannot be lowered to maintain harmonization with the Codex MRL of 0.1 ppm. (Unit F of the Notice). Also, the Codex MRL for grass hay is 50 ppm, and that proposed here is 300 ppm; the Codex MRL for field corn is 1 ppm, and that proposed here is 6 ppm and the same statement, that the tolerance cannot be lowered, applies.

Comment: Here is a great example of one of the many detrimental ramifications from the widespread use of GMO's. They drive up the levels of pesticide residues in crops for food and feed, while the majority of society is trying to avoid consumption of pesticides. It is unclear here, who has written this part of the FR Notice, EPA or Monsanto. The phrase, cannot be lowered is an ominous statement. If followed, it means that if a corporation benefits from commercializing a product, all other values and considerations must be cast aside.

Agency response . The rice grain tolerance of 15.0 ppm initially requested by Monsanto Company and cited in the notice of filing pesticide petition to establish a tolerance for glyphosate in or on food (April 17, 2002, 67 FR 18894) is not included in this tolerance petition. In addition, Monsanto Company has amended the tolerance petition by deleting the proposed tolerance increase to 6 ppm for wheat, grain and revising its Roundup UltraMax Herbicide label by removing all instructions related to a preharvest application of this product to Roundup Ready wheat. EPA has determined that the amended use instructions support the existing 5 ppm tolerance level for wheat, grain (40 CFR 180.364).

The pesticide petition process exists so that petitioners can request that EPA establish new food or feed tolerances, or increase existing tolerances, to accommodate new pesticide uses. Petitions are only filed when residue studies have demonstrated that food residues requiring tolerances may occur. Although EPA's approval of such petitions does authorize the potential for increased exposure levels, the existence of food tolerances is not indicative of significant consumer risk. Using worst-case assumptions that: (1) 100% of crops will be treated and (2) that residues will occur at tolerance levels in all cases, EPA has concluded that exposure to glyphosate from food, including all present and proposed tolerances, will utilize only 1.8% of the cPAD for the U.S. population, 3.8% of the cPAD for all infants less than 1 year old, and 3.6% of the cPAD for children (1 to 6 years old). Thus, the risk to human health does not exceed the Agency's level of concern (100% of the cPAD).

The phrase cannot be lowered indicates that glyphosate use patterns in the U.S. differ from those that have been considered by Codex, and therefore the new U.S. food and/or feed tolerances are not harmonized with established Codex MRLs. Codex procedures require that new pesticide uses and tolerances must first be approved by national governments before they can be considered by the Codex Committee on Pesticide Residues. As a result, differences between Codex MRLs and U.S. tolerances are anticipated as use patterns evolve. Codex uses the Periodic Review process to periodically update MRLs to reflect the modified use patterns.

Comment: In many parts of this FR Notice, it is not possible to tell who has written it, EPA or Monsanto. As a member of an organization working hard to promote an environmentally sound, economically viable, socially just and humane agriculture and food system in this country, I was expecting to see evidence of an agency working to protect human health and our environment, this is very disappointing. Furthermore, there is no consideration given here to the effects the increased use of this pesticide may have on the soil. Lab studies have demonstrated that glyphosate reduces nitrogen fixation associated with legumes and increases the susceptibility of crop plants to a number of diseases. Roundup is toxic to mycorrhizal fungi, with effects on some species observed at concentrations of 1 ppm, lower than those found in soil following typical applications.

Agency response . Publication of petitioner-generated summaries is dictated by the FFDCA, 21 U.S.C. 346a(d)(3). The Notice clearly indicates that the petitioner, Monsanto, has written the summary. However, much of this information can be found in the Agency's risk assessment document/supporting documentation for glyphosate. EPA has conducted a complete and thorough review of the available data for glyphosate. Based on the risk assessments conducted for glyphosate, the Agency determined that there is reasonable certainty that exposure to glyphosate will not pose unreasonable risks or adverse effects to humans or the environment.

The Agency has received no reports indicating that the use of glyphosate adversely effects nitrogen fixation in legumes or that it increases the disease susceptibility of crops. These type of environmental considerations are more appropriately raised in connection with the FIFRA registration process.

Comment: Several comments were received in the public docket that expressed concern over the tolerance approvals for glyphosate that will directly support new uses in glyphosate-tolerant crops, namely wheat, rice and bentgrass. The list of commenters are as follows: Mark Trechock/Staff Director/Dakota Resource Council, Annie Ray/Oregon Rural Action, Helge Hellberg/Marketing Director/California Certified Organic Farmers, Lauran Dundee/Regional Outreach Coordinator/Partners for Global Justice and Sustainable Communities, Kevin L. Williams/Field Coordinator/Western Organization of Resource Councils, Suzin Kratina/Chair of the Food Safety Task Force/Northern Plains Resource Council, Harriet Ritter and Renata Brillinger.

Agency response . The rice grain tolerance of 15.0 ppm initially requested by Monsanto Company and cited in the Notice of Filing Pesticide Petition to establish a Tolerance for Glyphosate in or on Food (April 17, 2002, 67 FR 18894), is not included in this final rule.

Tolerance actions for glyphosate are considered independently of the other regulatory assessments that a new crop trait must pass before it can be commercialized. Three U.S. Federal agencies regulate crops incorporating traits derived from biotechnology. The Food and Drug Administration (FDA) has responsibility for evaluating the safety of crops derived through biotechnology for use as food and feed. The U.S. Department of Agriculture, Animal Plant Health Inspection Service (USDA APHIS) is responsible for agronomic characteristics and environmental impact. EPA is responsible for the assessment of the human health and environmental risk of pesticide products, including plant-incorporated pesticides, and their registration under FIFRA, as amended. Commercialization by Monsanto of additional glyphosate-tolerant crops, i.e., wheat, rice and bentgrass, cannot occur until such time as the USDA APHIS and the FDA have received and evaluated necessary data from the registrant and granted necessary approvals. As of 2002, Monsanto has submitted a petition to USDA APHIS for GM bentgrass.

Despite the separate nature of the evaluations and approvals, much closer communication has developed between the three agencies in recent years. In early 2001, EPA and USDA APHIS established an interagency work group for products derived from biotechnology. Through this joint working group, EPA consults on a stewardship plan for each new herbicide-tolerant crop that addresses the management of pest resistance and the potential for weedy volunteer crops in their herbicide-tolerant crops and in crop rotations. This stewardship plan is then incorporated into a full environmental impact assessment by USDA APHIS that addresses the potential for development of resistant weed populations through pollen flow, in addition to effects on non- target organisms and agricultural practices. EPA and USDA APHIS have established a strong working relationship through this joint review process that helps ensure that the concerns of both agencies are adequately addressed prior to final approval by either.

Based on the incomplete status of the interagency approval process discussed above, EPA has decided not to register the use of glyphosate in or on herbicide-tolerant wheat or herbicide-tolerant bentgrass at this time.

Some commenters express concern over the potential contamination of organic crops through pollen drift from herbicide-tolerance crop varieties that may be grown on near-by farms. The issue of organic operations in proximity to operations that employ methods that are prohibited under organic rules is discussed in the National Organic Program, Final Rule, available on the USDA Web site at: http://www.ams.usda.gov/nop/nop2000/Final%20Rule/nopfinal.pdf .

The petition requested that 40 CFR 180.364 be amended by establishing a tolerance for residues of the herbicide glyphosate, in or on animal feed, nongrass, group at 400 part per million (ppm), grass, forage, fodder and hay, group at 300 ppm, wheat, forage at 10 ppm, wheat, hay at 10 ppm, and adding the potassium salt of glyphosate to the tolerance expression.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of glyphosate on animal feed, nongrass, group at 400 ppm, grass, forage, fodder and hay, group at 300 ppm, wheat, forage at 10 ppm, and wheat, hay at 10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the acute toxic effects caused by glyphosate are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed in the following Table 2.

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for glyphosate used for human risk assessment is shown in the following Table 3.

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.364) for the residues of glyphosate, in or on a variety of raw agricultural commodities. The current proposal to establish glyphosate tolerances at 300 and 400 ppm for animal feed, nongrass, group (Crop Group 18) and grass, forage, fodder and hay, group (Crop Group 17), respectively, is not expected to result in an increase in the dietary burden for cattle, poultry, and hogs. Respective dietary burdens of 210 ppm and 220 ppm were recently estimated by the Agency for dairy and beef cattle, including a contribution from alfalfa hay as the roughage component of the diet with a tolerance of 400 ppm. Furthermore, no impact is expected on the dietary burden to poultry or hogs since grass forage and hay are not feed items for these livestock, and the contribution from alfalfa was already considered. Risk assessments were conducted by EPA to assess dietary exposures from glyphosate in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. A review of the toxicity data base, including the developmental toxicity studies in rats and rabbits, did not provide an endpoint that could be used to quantitate risk to the general population and to females 13-50 years old from a single-dose administration of glyphosate. Therefore, no acute dietary analysis was conducted for glyphosate.

ii. Chronic exposure . The glyphosate chronic dietary exposure analysis was conducted using the DEEM TM software Version 7.73, which incorporates consumption data from USDA's CSFII, 1989-1992. The 1989-92 data are based on the reported consumption of more than 10,000 individuals over 3 consecutive days, and therefore represent more than 30,000 unique person days of data. Foods as consumed (i.e., apple pie) are linked to raw agricultural commodities and their food forms (i.e., apples-cooked/canned or wheat-flour) by recipe translation files internal to the DEEM TM software. Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

For chronic dietary exposure and risk assessments, an estimate of the residue level in each food or food-form (i.e., orange or orange-juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/food form. The resulting residue consumption estimate for each food/food form is summed with the residue consumption estimates for all other food/food forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates are expressed in mg/kg body weight/day and as a percent of the cPAD for chronic exposure. This procedure is performed for each population subgroup.

The Tier 1 chronic dietary exposure analysis for glyphosate is an upper bound estimate of chronic dietary exposure. The chronic dietary exposure analysis was performed for the general U.S. population and all population subgroups using DEEM TM default processing factors for rice and corn commodities, tolerance levels, and 100% crop treated data for the proposed commodities and all registered uses. For chronic dietary risk, the Agency's LOC is less than 100% cPAD. Dietary exposure estimates for representative population subgroups are presented in Table 4. The results of the chronic analysis indicate that the estimated chronic dietary risk as represented by the percent cPAD is below the Agency's LOC (100% cPAD) for the U.S. population and all population subgroups.

iii. Cancer . The HED Cancer Peer Review Committee classified glyphosate as a Group E chemical, negative for carcinogenicity in humans, based on the absence of evidence of carcinogenicity in male and female rats as well as in male and female mice.

iv. Anticipated residue and percent crop treated information . The Agency used tolerance levels and 100% percent crop treated (PCT) data for the proposed commodities and all registered uses.

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

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

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

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

Based on the GENEEC and SCI-GROW models, the EECs of glyphosate for acute exposures are estimated to be 21 parts per billion (ppb) for surface water and 0.0038 ppb for ground water. The EECs for chronic exposures are estimated to be 0.83 ppb for surface water and 0.0038 ppb for ground water, based on glyphosate treatment crops. To estimate the possible concentration of glyphosate in surface water resulting from direct application to water, the Agency assumed application to a water body 6 feet deep. At an application rate of 3.75 lb acid equivalent (ae)/A, the estimated concentration is 230 ppb. Because the glyphosate water-application estimate is greater than the crop application estimate, 230 ppb is the appropriate value to use in the chronic risk estimate.

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).

i. Non-occupational (recreational) exposures . Glyphosate is currently registered for use on the following residential non-dietary sites: Recreational areas, including parks and golf courses for control of broadleaf weeds and grasses, and lakes and ponds, including reservoirs for control of nuisance aquatic weeds. Based on the registered uses, adult and child golfers are anticipated to have short-term post-application dermal exposure at golf courses. Swimmers (adults, children and toddlers) are anticipated to have short-term post-application dermal and incidental ingestion exposures. However, since the Agency did not select dermal endpoints, no post-application dermal assessment is included; only a post-application incidental ingestion exposure assessment (swimmers) is included. Risk estimates for incidental ingestion by swimmers (adults, children, and toddlers) ranged from 7,600 to 36,000. It should be noted however, that glyphosate is used for non-selective weed control on emerged aquatic weeds. In this use pattern, it is unlikely that swimmers would be present in waterbodies with floating weeds present. Thus, the inclusion of the swimmer incidental ingestion exposure assessment is considered by the Agency to be conservative. Table 5 presents a summary of assumptions used to estimate the exposure to adult and toddler child swimmers and the corresponding risk estimates.

The MOEs presented in Table 5 for post-application exposure by swimmers to glyphosate in aquatic weed control applications are greater than 100 and do not exceed the Agency's LOC for short-term non-occupational (recreational) exposures (MOEs less than 100).

ii. Residential exposures . Glyphosate, isopropylamine salt is also registered for broadcast and spot treatments on home lawns and gardens by homeowners and by lawn care operators (LCOs). Based on the registered residential use patterns, there is a potential for short-term dermal and inhalation exposures to homeowners who apply products containing glyphosate (residential handlers). Additionally, based on the results of environmental fate studies, there is also a potential for short- and intermediate-term post-application dermal exposures by adults and toddlers and incidental ingestion exposures by toddlers. However, since the Agency did not select short- or intermediate-term dermal or inhalation endpoints, no residential handler or post-application dermal assessment is included; only a post-application toddler assessment for incidental ingestion exposures is included. Risk estimates for toddler post-application incidental ingestion exposures ranged from 7,200 to greater than 10 6 . All recreational and residential exposures assessed do not exceed the Agency's level of concern (MOEs less than 100). Table 6 provides a summary of the short- and intermediate-term risk estimates for post-application incidental ingestion exposures to toddlers.

All MOEs calculated for post-application toddler exposures do not exceed the Agency's level of concern for residential exposures (MOEs less than 100).

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 glyphosate 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, glyphosate 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 glyphosate 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 toxicology data base for glyphosate is adequate according to the Subdivision F Guideline requirements for a food-use chemical. Acceptable developmental toxicity studies in the rat and rabbit are available, as is an acceptable 2-generation reproduction study in the rat. Based on the available data, the Agency determined that there is no evidence of either a quantitative or qualitative increased susceptibility following in utero glyphosate exposure to rats and rabbits, or following prenatal/postnatal exposure in the 2-generation reproduction study in rats.

3. Conclusion . There is a complete toxicity data base for glyphosate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency determined that the FQPA Safety Factor to protect infants and children can be removed (reduced from 10X to 1X) for all population subgroups and exposure scenarios because:

1. The toxicology data base is complete.

2. A developmental neurotoxicity study is not required.

3. The dietary (food and drinking water) 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, short-term, intermediate-term, chronic, and cancer.

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

1. Acute aggregate risk (food + drinking water) . The Agency did not identify an appropriate acute dietary endpoint that is the result of a single-dose administration of glyphosate. Accordingly, glyphosate is not expected to pose an acute risk.

2. Chronic aggregate risk (food + drinking water) . Using the exposure assumptions described in this unit for chronic exposure (tolerance level residues, DEEM  TM default processing factors for rice and corn commodities, and 100% crop treated data for all proposed commodities and registered uses), EPA has concluded that exposure to glyphosate from food will utilize 1.8% of the cPAD for the U.S. population, 3.6% of the cPAD for [All Infants (less than 1 year old) and 3.9% of the cPAD for children 1-6 years old. The results of the chronic analysis (Table 4 in this unit) indicate that the chronic dietary risk estimates for the general U.S. population and all population subgroups associated with the existing and proposed uses of glyphosate do not exceed the Agency's LOC (less than 100% of the cPAD). Based on the use pattern, chronic residential exposure to residues of glyphosate is not expected. In addition, there is potential for chronic dietary exposure to glyphosate 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 Table 7 below:

3. Short-/intermediate-term aggregate risk (food + residential + water) . In aggregating short-/intermediate-term risk, HED considered background chronic dietary exposure (food + water) and short/intermediate-term incidental oral exposures (see Tables 6 and 7). Because the incidental oral ingestion exposure estimates for toddlers from residential turf exposures (Table 7) exceeded the incidental oral exposure estimates from post-application swimmer exposures (Table 6), the Agency conducted this risk assessment using exposure estimates from just the worst-case situation. No attempt was made to combine exposures from the swimmer and residential turf scenarios due to the low probability of both occurring.

The total short-/intermediate-term food and residential aggregate MOEs are 1,800-2,300. As these MOEs are greater than 100, the short-/intermediate-term aggregate risk does not exceed the Agency's LOC. For surface water and ground water, the EECs of glyphosate are less than the DWLOCs for glyphosate in drinking water as a contribution to short-/intermediate-term aggregate exposure. Therefore, the Agency concludes with reasonable certainty that residues of glyphosate in drinking water do not contribute significantly to the short-/intermediate-term aggregate human health risk at the present time. Table 8 summarizes the short-/intermediate-term aggregate exposure to glyphosate residues.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to glyphosate residues.

Adequate enforcement methods are available for analysis of residues of glyphosate in or on plant and livestock commodities. These methods include GLC (Method I in Pesticides Analytical Manual (PAM) II; the limit of detection is 0.05 ppm) and HPLC with fluorometric detection. Use of the GLC method is discouraged due to the lengthiness of the experimental procedure. The HPLC procedure has undergone successful Agency validation and was recommended for inclusion in PAM II. A GC/MS method for glyphosate in crops has also been validated by EPA's Analytical Chemistry Laboratory (ACL). Thus, adequate analytical methods are available for residue data collection and enforcement of the proposed tolerances of glyphosate in/on the nongrass animal feed crop group; the grass forage, fodder, and hay crop group; wheat forage and hay; and livestock commodities.

Codex and Mexican maximum residue limits (MRLs) are established for residues of glyphosate (glifosato) per se and Canadian MRLs are established for combined residues of glyphosate and AMPA in a variety of raw agricultural, processed, and animal commodities. Currently a relevant Codex MRL for hay or fodder (dry) of grasses is established at 50 ppm. No Canadian MRLs are established for any grass commodity. A Mexican MRL is established for pasture at 0.2 ppm. Because of the higher residue levels resulting from the proposed use pattern, harmonization of U.S. grass tolerances with existing Codex or Mexican MRLs is not possible.

For wheat-related commodities, relevant Codex MRLs exist for: wheat grain at 5 ppm; unprocessed wheat bran at 20 ppm; wheat flour at 0.5 ppm; wheat wholemeal at 5 ppm; and straw and fodder (dry) of cereal grains at 100 ppm. Canadian MRLs are established for: wheat at 5 ppm and wheat milling fractions (excluding flour) at 15 ppm. A Mexican MRL is established for wheat at 5 ppm. By maintaining the wheat, milling fractions (excluding flour) tolerance at 20 ppm, harmony with international tolerances for wheat processed fractions can be maintained.

There are currently no Codex or Canadian MRLs established for glyphosate for any nongrass animal feed items. A Mexican MRL is established for alfalfa at 200 ppm. Harmonization with this level is not possible due to the higher residue levels found in the submitted field trial studies.

None.

Therefore, the tolerance is established for residues of glyphosate, in or on animal feed, nongrass, group at 400 ppm and grass forage, fodder and hay, group at 300 ppm and the potassium salt of glyphosate is added to the tolerance expression. Based on the Agency's decision not to register tolerances for glyphosate use in or on herbicide-tolerant wheat, the current tolerances on wheat are not modified.

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-2002-0232 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0232, 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 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-2002-0199. 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 March 14, 2002 (67 FR 11476) (FRL-6825-1), 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 a pesticide petition (PP 9F6051) by Aventis Crop Science USA, 2 TW Alexander Drive, Research Triangle Park, NC 27709. This notice included a summary of the petition prepared by Aventis CropScience USA, the registrant. Subsequent to the filing of this petition, Bayer Corporation acquired Aventis CropScience to form Bayer Crop Science. Therefore, the registrant is now Bayer Crop Science. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.583 be amended by establishing tolerances for residues of the fungicide triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1 H -1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on barley, grain; barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, straw at 0.05 parts per million (ppm).

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1 H -1,2,4-triazol-1-ylmethyl)cyclopentanol, on barley, grain; barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, straw at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for triticonazole used for human risk assessment is shown in the following Table 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-2002-0233. 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 30, 2000 (65 FR 52749) (FRL-6739-8), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 0F6136) by Plant Products Co. Ltd., f314 Orenda Rd., Brampton, Ontario, Canada L6T 1G1. This notice included a summary of the petition prepared by the petitioner Plant Products Co. Ltd. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Pseudozyma flocculosa strain PF-A22 UL in or on all food commodities.

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

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

Pseudozyma flocculosa was isolated in 1986 from the leaves of red clover, Trifolium pratense , infected with powdery mildew, Erysiphe polygoni , by researchers at Agriculture and Agri-Food Canada, Harrow, Ontario. Initially, this organism was erroneously identified as a new ascomycetous yeast with an anamorphic state in the broad genus Sporothrix and a teleomorphic state in the genus Stephanoascus . In 1995, its taxon was changed to P. flocculosa following ribosomal DNA analysis. The genus Pseudozyma contains other smut-like anamorphs, including P. rugulosa (formerly Sporothrix rugulosa ). P. flocculosa is a phyllosphere epiphyte and hyperparasite of primarily powdery mildew but has been isolated in association with other leaf-surface molds. It is widely distributed in North America (Canada and USA) and in Europe on aerial plant surfaces in field or greenhouse agricultural ecosystems.

P. flocculosa antagonizes a number of different powdery mildew fungi ( Sphaerotheca pannosa var. rosae, Sphaerotheca fulginea, Erysiphe graminis var. tritici and Erysiphe polygoni ) on many different plants in greenhouse and field environments when the relative humidity is greater or equal to 70%. This fungus is a necrotroph mycoparasite that kills susceptible target host cells upon contact or in close proximity. Rapid death and collapse of host cells without penetration is brought about by the secretion of three fungitoxic unsaturated C-17 fatty acids (9-heptadecenoic acid, 6-methyl-9-heptadecenoic acid and 4-methyl-7,11-heptadecadienoic acid) and an acyclic norterpene (2, 6, 10, 14, 18-pentamethyl-2, 6, 8, 10, 12, 14, 17-nonadecaheptene-1,19-diol). The fungitoxins disrupt susceptible plasma membranes and cytoplasmic organelles within 30 minutes of exposure. The inhibitory response includes a loss of proteins and electrolytes. After 24 hours, the host cells rapidly collapse and die as a result of the activity of the fungitoxins on the host cell's membranes and lipids. Sensitivity to the unsaturated C-17 free fatty acids is related to a high degree of unsaturation of phospholipid fatty acids and a low proportion of sterols.

P. flocculosa strain PF-A22 UL was considered of low toxicity and no pathogenicity based on the results of the Tier I toxicology studies. Tier II and Tier III studies were not required because the results from the Tier I studies were sufficient to satisfy guideline requirements. On the basis of the studies submitted, it was considered a Toxicity Category III pesticide for acute oral effects due to the amount dosed only, and Toxicity Category IV for dermal and primary dermal irritation health effects. These and additional toxicology studies are summarized below and in more detail in the Product Monograph for Pseudozyma flocculosa strain PF-A22 UL which is found in the OPP docket number OPP-2002-0233.

1. Acute oral toxicity/pathogenicity study (OPPTS 885.3050) (Master Record Identification (MRID) numbers 451152-04 and 453634-01). No signs of toxicity or pathogenicity were noted when Sporodex WP, a wettable powder formulation containing 2.0% (weight/weight) P. flocculosa strain PF-A22 UL was administered to rats via the oral route.

In an acute oral toxicity study, groups of fasted 6-7 week old Fisher 344 rats (12/sex) were administered a single oral dose of Sporodex WP in USP sterile water for injection at doses of 5.8 x 10 8 colony-forming units (CFU) per animal for males and 5.6 x 10 8 CFU per animal for females. An equal number of animals were dosed with heat-killed test substance and four animals/sex served as untreated controls. The animals were then observed for a period of up to 21 days with interim scheduled sacrifices. No effect on body weight gain and no apparent signs of treatment-related toxicity, infectivity or pathogenicity were observed in any of the treated animals during the study period. Clearance of the test organism occurred by, or prior to, post-treatment day 7. Based on the results of this study, Sporodex L and its active ingredient, P. flocculosa , is not considered toxic or pathogenic to male or female Fisher 344 rats.

2. Acute pulmonary toxicity/pathogenicity study (OPPTS 885.3150) (MRID numbers 451152-06 and 453634-01) . The potential toxicity and pathogenicity of P. flocculosa was tested by observing the effects following a single intratracheal instillation of 3.2 x 10 7 CFU of the test organism (TS) to each of 12 male and 12 female CD rats. An equal number of animals were treated with heat-killed test substance (KTS) and four animals/sex served as untreated controls. Animals were observed for up to 14 days with interim scheduled sacrifices.

A total of 15 rats (3/8 male and 2/8 female TS-dosed rats and 6/8 male and 4/8 female KTS-dosed rats) died on days 2 and 3. Laboured respiration, rough hair coat, ocular discharge and nasal discharge were observed in both TS- and KTS-dosed rats. Hunched posture and lethargy were also observed in one female and one male TS-dosed rat, respectively. The presence or absence of clinical symptoms were not indicative of spontaneous deaths.

Due to the large number of spontaneous deaths and a number of missed data collections, data for evaluating effects on body weights, food consumption and relative organ weight were limited. At the end of the 14-day long study, administration of P. flocculosa did not have a statistically significant effect on body weight. Analyses of daily food consumption and relative organ weights were skewed as they were either not determined or did not include animals that died prior to their scheduled sacrifice dates.

At necropsy, liver lesions and lesions and enlargement of the lung and spleen were observed in both TS- and KTS-dosed rats. Confluent dark areas were also seen in the kidneys of a single male TS-dosed rat. These necropsy findings were considered consistent with the method of dosing and the body's normal immunological response to a foreign substance.

Pseudozyma flocculosa was detected in the lungs and lymph nodes and the stomach and small intestine of TS-dosed animals only. Counts in these tissues were below the limit of detection by day 7.

Based on this study, P. flocculosa is toxic, but not infective or pathogenic, at the dose administered when introduced by the intratracheal route to male and female CD rats. This acute pulmonary study, however, was originally classified as unacceptable due to major deficiencies in the collected data and a possible dosing error, as indicated by the presence of the microbial pest control agent (MPCA) in the stomach and small intestines on the day of dosing. However, there was relevant pathogenicity information that indicated clearance of the MPCA. Thus, this study is considered to be supplemental because it provides acceptable information regarding infectivity/pathogenicity; however, this study does not differentiate the cause of certain mortalities in the TS and KTS treatments. A confirmatory acute pulmonary toxicity/pathogenicity study using the technical grade of the active ingredient (TGAI) and testing of the sterile filtrate from the production culture will therefore be required to provide this additional information as a condition of registration.

3. Acute pulmonary range-finding study (OPPTS 885.3150) (MRID numbers 451152-07 and 453634-01) . In order to determine whether the test substance (in both its viable and non-viable forms), P. flocculosa , was the cause of the deaths, a subsequent acute pulmonary range-finding toxicity study was conducted. In this range-finding study, groups of young adult CD rats (5/sex/dose level) were exposed by the intratracheal route to P. flocculosa (4.2 x 10 7 CFU/mL) in ASTM Type 1 water at doses of 4.2 x 10 7 , 3.4 x 10 7 , 6.8 x 10 6 and 3.4 x 10 6 CFU/animal. Animals were then observed for 14 days. There were no mortalities and all animals gained weight during the study. Rough hair coat occurred in a dose-dependent manner with all 5 animals/sex exhibiting this symptom at the highest dose of 4.2 x 10 7 CFU/animal. One female dosed with 4.2 x 10 7 CFU experienced tremors, closed eyes and rough hair coat. Pseudozyma flocculosa was classified as being of slight toxicity (EPA Toxicity Category IV) based on adverse effects observed in some test animals.

This acute pulmonary study was considered supplemental. According to USEPA OPPTS 885.3150, the minimum dose is 10 8 units of the MPCA per test animal. The maximum dose level used in this study, however, was only 4.2 x 10 7 CFU/animal. Furthermore, infectivity was not addressed; however, the acute pulmonary toxicity/pathogenicity study did address infectivity sufficiently. Consequently, this study does not satisfy the guideline requirement for an acute pulmonary study (OPPTS 885.3150) in the rat. EPA, in considering the two studies together, believes that there are sufficient data with which to determine the toxicity and pathogenicity of Pseudozyma flocculosa . As any potential inhalation risk that is raised by these studies is primarily a worker risk, EPA is requiring that a respirator be worn by workers to limit any inhalation exposures. In addition, a Restricted-Entry Interval (REI) of 4 hours is required for early entry (post-application) workers or other persons entering treated greenhouses. Finally, a confirmatory acute pulmonary toxicity/pathogenicity study using the TGAI and testing of the sterile filtrate from the production culture will be required as a condition of registration.

4. Intraperitoneal toxicity/infectivity study (OPPTS 885.3200) (MRID numbers 451152-08 and 453634-01) . In an acute intraperitoneal toxicity/infectivity study, groups of young adult CD rats (4/sex/scheduled sacrifice date) were exposed by the intraperitoneal route to an undiluted suspension of P. flocculosa (TS) at a dose of 3.5 x 10 7 CFU/animal (in 1.0 mL). Animals were then observed for up to 14 days. An equal number of young adult CD rats were similarly injected with heat-killed test substance (KTS). An undosed naive control (NC) group consisting of 4 rats/sex was also included in the study. Cage side observation for clinical symptoms was performed daily and animal body weights and food consumption were monitored.

No unscheduled deaths occurred. Designated animals from the TS and KTS groups were sacrificed on days 0, 7, and 14 and gross necropsies were performed. The NC group of animals was sacrificed and necropsied at the end of the 14-day study. Infectivity and clearance were assessed by quantitatively recovering the MPCA from the blood, lungs and lymph nodes, spleen, kidneys, liver, heart, stomach and small intestine, peritoneal fluid, caecum and brain.

No adverse clinical signs were observed at any point of the study in any of the groups of rats. Body weight gain of TS-dosed male rats was significantly decreased while this group's food consumption was significantly increased compared to NC animals. There was no significant difference between KTS-dosed and NC animals in terms of body weight, body weight gain or food consumption. Upon necropsy of TS- and KTS-dosed animals, white nodules and higher relative spleen weights were observed and attributed to a normal immune response to a foreign substance. The detection of P. flocculosa in the peritoneal fluid lavage of TS-dosed male rats was consistent with the method of administration. Clearance of P. flocculosa from all other tissues and fluids occurred by day 7. No test substance was detected from any of the organs of the KTS-dosed or NC animals.

At the dose administered, P. flocculosa was slightly toxic but not pathogenic to male and female CD rats when introduced by the intraperitoneal route.

5. Acute dermal toxicity/irritation study (OPPTS 885.3100) (MRID numbers 451152-09 and 453634-01) . In an acute dermal toxicity study, a single group of New Zealand White rabbits (5/sex) was dermally exposed to 1.2 x 10 7 CFU P. flocculosa (equivalent to approximately 0.82-0.90 g/kg bw for males and 0.80-0.91 g/kg bw for females), for 24 hours to an area equivalent to approximately 10% of the dorsal skin surface. Following exposure, the animals were observed for a period of 14 days.

No treatment-related signs of toxicity or skin irritation were observed in any animal during the 14-day observation period. At the dose administered, P. flocculosa was not considered toxic or irritating to the skin.

6. Primary eye irritation study (OPPTS 870.2400) (MRID numbers 451152-10 and 453634-01) . Administration of 0.1 g of Sporodex WP to the eyes of rabbits resulted in slight conjunctival redness in 5/6 animals at the 1-hour scoring interval and in 2/6 rabbits at the 24-hour scoring interval. By the 48-hour scoring interval, all signs of ocular irritation had subsided. There were no other adverse clinical symptoms or mortalities during the 7-day observation period. The maximum irritation score (MIS) was 1.7 at the 1-hour scoring interval and the maximum average score (MAS) was 0.22 over the 24-, 48- and 72-hour scoring intervals. Based on the MAS, Sporodex WP was classified as minimally irritating.

7. Subchronic, chronic toxicity and oncogenicity . Survival, replication, infectivity, significant toxicity or persistence of the MPCA was not observed in the test animals treated in Tier I acute oral, pulmonary and intravenous toxicity/infectivity tests. Consequently, higher tier tests involving subchronic and chronic testing, oncogenicity testing, mutagenicity and teratogenicity were not required based on the lack of concerns following analysis of Tier I test results. However, a genotoxicity computer search for Pseudozyma flocculosa was conducted. No reports of mammalian toxicity were found in standard biological, chemical and toxicological abstracts. The applicant included computer literature search results to a number of keywords such as pseudozyma ; tilletiopsis, fate, non target, carcin, mutagen; toxic, pathogen, antibiotic, polyen; sporothrix, sporobolomyces, rhodotorula, phyllosphere yeast; carcinog and teratogen. The literature search covered AGRICOLA , Biological Abstracts, CAB Abstracts, CHEMTOX, RTEX and AGRIS databases from 1980 to 1999.

8. Hypersensitivity (dermal sensitization) study (OPPTS 870.2600) . The applicant has also submitted an acceptable waiver rationale from conducting a dermal sensitization study based on the assumption that most microorganisms contain substances that could elicit a hypersensitivity response. Pseudozyma flocculosa is considered a potential sensitizing agent, therefore, the statement, “POTENTIAL SENSITIZER” is required on the principal display panels of the technical and end-use formulation labels. The use of personal protective equipment will also be required to mitigate against potential dermal sensitization in occupationally exposed workers/handlers.

9. Reports of hypersensitivity incidents (OPPTS 885.3400) . Skin sensitizing studies are not considered substitutes for timely reports of hypersensitivity incidents subsequent to registration approval. No adverse effects have been noted among researchers who have worked closely with P. flocculosa strain PF-A22 UL for up to 10 years. The applicant will be expected to report any subsequent findings of hypersensitivity or other health incidents to workers, applicators, or bystanders exposed to the MPCA as a condition of registration. Incident reports are to include details such as a description of the MPCA and formulation, frequency, duration and routes of exposure to the material, clinical observations, and any other relevant information.

10. Effects on the immune systems (OPPTS 880.3800, immune response) . The active ingredient, P. flocculosa strain PF-A22 UL, is not known to be a human pathogen nor an endocrine disrupter. The submitted toxicity/pathogenicity studies in the rodent indicate that, following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. Therefore, no adverse effects to the immune systems are known or expected. Based on this rationale, the registrant waiver request for OPPTS 880.3800 (Immune Response) was found to be acceptable.

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

1. Food . The proposed food use pattern is likely to result in residues in or on food and feed. Residues of the microbial pesticide are likely to be removed from treated food by washing, peeling, cooking and processing. Even if residues are not removed, however, EPA believes that dietary exposure to the microbial agent will result in negligible to no risk to consumers. Although Pseudozyma species are ubiquitous in nature and have been isolated from a wide variety of plant surfaces including leaf litter, clover, maize and cucumber, no adverse effects from dietary exposure have been attributed to natural populations of Pseudozyma flocculosa . Furthermore, no adverse effects were observed at maximum hazard dose levels in the acute oral toxicity/pathogenicity study and there are no reports of known mammalian toxins being produced by the MPCA. Subchronic and chronic dietary exposure studies were not required because the Tier I acute oral study demonstrated a low level of toxicity and no pathogenicity potential for the active microorganism. Because of the low toxicity profile and low potential exposure of the MPCA expected for the proposed uses, there is no concern for chronic risks posed by dietary exposure for the general population or sensitive subpopulations, such as infants and children. In addition, an extensive literature search yielded no reports of mammalian toxins being produced by P. flocculosa . The fungitoxic unsaturated C-17 fatty acids and acyclic norterpene produced by the MPCA have not been reported to be toxic to mammals. Neither this organism nor its close relatives are listed among microbial contaminants of food. Therefore, EPA expects negligible to no dietary risk from exposure to naturally-occurring and isolated P. flocculosa strain PF-A22 UL residues.

2. Drinking water exposure . Although heavy rainfall likely carries P. flocculosa into neighboring aquatic environments, growth and survival of terrestrial fungi such as P. flocculosa is limited in such environments. Thus, it is not expected to proliferate in aquatic habitats following incidents of direct or indirect exposure (e.g., runoff from treated greenhouses). Moreover, P. flocculosa is not considered to pose a risk to humans from exposure to drinking water because of minimal to non-existent toxicity. Accordingly, drinking water is not specifically screened for P. flocculosa as a potential indicator of microbial contamination or as a direct pathogenic contaminant. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of significant transfer of residues to drinking water. Therefore, the potential of exposure and risk via drinking water is likely to be minimal to non-existent for this MPCA.

The current label does not allow applications to turf, residential or recreational areas. Because the use sites are in greenhouses, exposure to the U.S. population including infants and children in school, residential and daycare facilities is likely to be minimal to non-existent. Consequently, the health risk posed by P. flocculosa strain PF A-22 UL from non-occupational dermal and inhalation exposures to the general public, including infants and children, is expected to be negligible to non-existent. Any concerns for potential inhalation risk is for occupational exposures, and as mentioned previously, will be mitigated by the requirement of a respirator and restriction of the reentry interval.

The Agency has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. EPA is not aware of any other bacteria or other substances, besides naturally-occurring strains of Pseudozyma , that share a common mechanism of toxicity with this active ingredient. Given the low toxicity and pathogenicity profile of P. flocculosa , even if there were any other substances with which P. flocculosa shared a common mechanism of toxicity, no adverse cumulative effects are expected.

Based on the toxicology data submitted and other relevant information in the Agency's files, there is reasonable certainty no harm will result from aggregate exposure of residues of Pseudozyma flocculosa strain PF-A22 UL to the U.S. population, including infants and children, under reasonably foreseeable circumstances when the microbial pesticide product is used as labeled. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on data submitted demonstrating low toxicity at the maximum doses tested and a lack of information showing adverse effects from exposure to naturally occurring P. flocculosa as well as a consideration of the product as currently registered and labeled. As a result, EPA establishes an exemption from tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of Pseudozyma flocculosa strain PF-A22 UL in or on all food commodities.

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. Margins of exposure (safety) are often referred to as uncertainty (safety) factors. In this instance, based on all the available information, the Agency concludes that P. flocculosa strain PF-A22 UL is practically non-toxic to mammals, including infants and children. Thus, there are no threshold effects of concern and, as a result the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. As a result, EPA has not used a margin of exposure (safety) approach to assess the safety of P. flocculosa strain PF-A22 UL.

EPA does not have any information regarding endocrine effects of this microbial pesticide at this time. There is no evidence to suggest that use of P. flocculosa strain PF-A22 UL at the proposed concentrations will adversely affect the endocrine system. The active ingredient, P. flocculosa strain PF-A22 UL, is not known to be a human pathogen nor an endocrine disrupter. The submitted toxicity/pathogenicity studies in the rodent indicate that, following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. Therefore, no adverse effects to the endocrine systems are known or expected.

As part of the standard Quality Control measures, the Agency is requiring microbial assays and analytical methods to identify the active ingredient and potential contaminants. Analytical methods are available and sufficient to identify metabolites and contaminants within regulatory levels. All batches containing potential human pathogens are to be destroyed. The MPCA is identified using a combination of morphological traits, molecular techniques and biological activity.

The identification of Pseudozyma to the species level is done using a standard mycological approach. Pseudozyma species can be differentiated from morphologically similar species such as Hyalodendron, Tilletiopsis, Sporobolomyces and Sporothrix . The branching conidiophores of Pseudozyma can be confused with those produced by Hyalodendron ; however, the whole cell hydrolysates of this filamentous basidiomycete contain xylose which is not found in Pseudozyma . Tilletiopsis and Sporobolomyces , other saprophytic wild yeasts on aerial plant surfaces, are different from Pseudozyma in that they produce spores that are forcibly discharged upon sporulation (ballistospores). Furthermore, Tilletiopsis species produce a fungus-degrading β-1,3 glucanase that is not produced by Pseudozyma species. The genus Sporothrix represents a group of anamorphic ascomycetous yeasts such as Sporothrix schenckii (type), an animal pathogen. Physiologically, Pseudozyma species differ greatly from Sporothrix species. Unlike the ascomycetous Sporothrix anamorphs, P. flocculosa shows positive reactions in Diazonium Blue B and urease tests typical of all basidiomycetous yeasts. Also, the major ubiquinone is Q-10 rather than Q-8 or Q-9 typical of the ascomycetes, Saccharomycopsis and Stephanoascus .

Strain PF-A22 UL can be differentiated from other strains of P. flocculosa using a DNA-based technique called multiplex polymerase chain reaction (multiplex PCR). The multiplex PCR system is essentially a cocktail of different primers which allows the rapid assessment of numerous DNA fragments in a single PCR amplification. The protocol is based on the amplification of two nuclear regions, (ITS and NS), and one mitochondrial region (ML). Those regions were found to be discriminant in the identification of P. flocculosa PF-A22 UL.

The integrity and consistency of the MPCA is ensured by two methods. The first method is a DNA-based PCR technique called random amplified microsatellites PCR (RAMS). Microsatellites are hypervariable non-coding regions of DNA within the genome that evolve more rapidly than coding DNA. The other method is a bioassay that measures biological activity. The biological activity of the MPCA is measured by the inhibition zone created when a susceptible organism is grown next to it. Given that the pest controlled, Sphaerotheca species, is an obligate biotroph, it cannot be used directly in this bioassay. Instead, a Phomopsis species is used because its sensitivity to P. flocculosa's fungitoxic secretions is similar.

There are no Codex Maximum Residue Levels or exemption from tolerances for the microbial active ingredient Pseudozyma flocculosa strain PF-A22 UL.

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-2002-0233 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.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-2002-0233, 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 exemption from the 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 (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 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 (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 control number OPP-2002-0229. 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 January 4, 2002 (67 FR 592) (FRL-6812-2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of a pesticide petition (PP 1F06300) by Aventis CropScience, 2 Alexander Drive, Research Triangle Park, NC 27709. This notice included a summary of the petition prepared by, the registrant. Subsequent to the filing of this petition, Bayer Corporation acquired Aventis CropScience to form Bayer CropScience. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide [4H-Imidazol-4-one, 3,5-dihydro-5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-, (S)-], fenamidone and its metabolites RPA 412708, RPA 412636 and RPA 410193, in or on letttuce, head at 15 ppm and lettuce, leaf at 20 part per million (ppm).

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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 fenamidone on lettuce, head at 15 ppm and lettuce, leaf at 20 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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

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

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

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

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

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

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The Agency notes that there is a degree of uncertainty in extrapolating exposures for certain population subgroups which may not be sufficiently represented in the consumption surveys (i.e, nursing infants). Therefore, risks estimated for these subpopulations were included in representative populations having sufficient numbers of survey respondents (i.e., all infants or females 13-50 years old). Thus, the population subgroups listed in Table 3 include those subgroups having sufficient numbers of survey repondents in CSFII food consumption survey. The acute dietary exposure analysis assumed tolerance level residues and 100% crop treated (Tier 1 analysis).

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: The chronic dietary exposure analysis incorporated average residues from the field trial studies and assumed 100% crop treated. (Tier 2 analysis) The most highly exposed population subgroup for the chronic analysis was children 7-12 years old at 10% cPAD.