The Office of Management and Budget (OMB) has determined that this rule is significant for the purpose of Executive Order 12866 and, therefore, it has been reviewed by OMB.

In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501), the information collection and record keeping requirements included in this rule have been submitted for approval to OMB. Please submit written comments to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20503. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this rule.

Comments are being solicited from the public concerning this proposed information collection and record keeping requirements. This outside input will help:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed collection of information, including the validity of the methodology and assumption used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission responses.)

Title: General Administrative Regulation; Submission of Policies, Provisions of Policies, and Rates of Premium.

Abstract: This rule revises guidelines for the submission of policies or other material to the Board under section 508(h) of the Act. In accordance with that section of the Act, this rule establishes the process for the submission of policies, plans of insurance, and rates of premium, the deadlines for the review and approval process by the Board, and the respective roles and responsibilities of FCIC and the applicant related to the submission. This rule specifies information that must be included in a new or revised submission and the format it must be in to be considered for Board approval. This rule establishes requirements and guidelines for the reimbursement of research and development costs and maintenance costs for such submissions approved by the Board and the payment of fees by insurance companies after the maintenance period has expired. It also requires non-reinsured supplemental policies developed by companies reinsured by FCIC to be submitted to FCIC for review in accordance with provisions contained in the Standard Reinsurance Agreement (SRA).

Purpose: To amend 7 CFR part 400 by revising subpart V.

Burden statement: This rule is needed to ensure that the Board receives complete submissions that are ready for review and approval. It also ensures the fair and equitable distribution of limited funds for research and development costs and maintenance costs. This rule will ensure an effective, orderly, and efficient crop insurance marketplace, and that the Federal crop insurance program is delivered to all producers in a manner that does not unfairly discriminate among producers or insurance companies.

The burden associated with this rule, with the exception of reading the rule, is in the development and submission of a policy, revision to a policy or rates of premium for any policy or plan authorized under the Act. FCIC estimates that annually 75 people (excluding Federal employees) will spend 2 hours reading this document for a total of 150 hours (75 × 2 = 150). FCIC estimates people in 14 positions (marketing manager, computer manager, financial manager, technical writer, actuary, accountant, lawyer, economist, computer programmer, underwriter, paralegal, marketing researcher, statistician, and office assistant) will respond for a total of 210 respondents (14 positions × 15 submissions = 210). FCIC estimates 105 annual responses (15 × 7 = 105) due to 15 applicants completing seven objectives (preparing the submission, modifying the submission, corresponding with the Board, preparation and presentation to the Board, responding to issues, negotiating agreements, costs and fees and maintenance of approved products). To determine approximate annual burden hours, FCIC estimates 15 entities will prepare a submission (applicants) and will spend the following amount of time for each of the seven objectives: (1) Preparing and submitting the submission—22,500 hours (15 applicants × 1,500 hours = 22,500); (2) Modifying the submission prior to Board approval—15,000 hours (15 applicants × 1,000 hours = 15,000); (3) Preparation of correspondence between the Board and applicant—150 hours (15 applicants × 10 hours = 150); (4) Preparation and presentation of the submission to the Board—600 hours ( 15 applicants × 40 hours = 600 hours); (5) Responding to procedural, policy, and data automation issues subsequent to Board approval—15,000 hours (15 applicants × 1,000 hours = 15,000); (6) Negotiation of agreements, costs and fees—600 hours (15 applicants × 40 hours); and (7) Maintenance of approved products—3,000 hours (15 applicants × 200 hours = 3,000).

Estimate of Burden: The public reporting burden for this collection of information is estimated to average 543 hours per response.

Respondents: Insurance companies, insureds, insurance agents, and other persons or entities who may wish to submit policies or policy provisions to the Board for approval.

Estimated Annual Number of Respondents: 210.

Estimated Annual Number of Responses Per Respondent: 0.5.

Estimated Annual Number of Responses: 105.

Estimated Total Annual Burden of Respondents: The total public burden for this rule is estimated at 57,000 hours.

Record keeping requirements: FCIC requires records to be kept for three years, and all records required by FCIC are retained as part of the normal business practice. Therefore, FCIC is not estimating additional burden related to record keeping.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of 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 UMRA.

The policies contained in this rule do 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. Nor does this rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the states is not required.

This regulation will not have a significant economic impact on a substantial number of small entities. Additionally, the regulation does not require any greater action on the small entities than is required on the part of large entities. The amount of work required of the insurance companies will not increase because the information must already be collected under the present policy. No additional work is required as a result of this action on the part of either the insured or the insurance companies. Therefore, this action is determined to be exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605) and no Regulatory Flexibility Analysis was prepared.

This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.

This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.

This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. The administrative appeal provisions published at 7 CFR part 11 or 7 CFR 400.169, as applicable, must be exhausted before any action for judicial review of any determination or action by FCIC may be brought.

This action is not expected to have a significant economic impact on the quality of the human environment, health, and safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.

On July 16, 2001, FCIC published this rule as a proposed rule (66 FR 36951-36960). During the comment period, Congress enacted section 2103 of the 2001 Supplemental Appropriations Act, which authorized FCIC to promulgate this rule without regard to the notice and comment provisions of section 533 of title 5, United States Code, the Statement of Policy of the Secretary of Agriculture effective July 24, 1971, relating to notices of proposed rulemaking and public participation in rulemaking, and chapter 35 of title 44, United States Code. Congress also required that this rule be effective on the date of publication.

FCIC makes available standard policies for producers to insure certain crops against various agricultural production risks and perils. Under the provisions of section 508(h) of the Act, (7 U.S.C. 1501 et seq.) any person may submit or propose other crop insurance policies, plans of insurance, provisions of policies, or rates of premium. These policies may be submitted without regard to limitations contained in the Act.

The Act requires that FCIC issue regulations to establish guidelines for the submission and Board review of policies or other material submitted to the Board under the Act. This rule prescribes guidelines for the timing, content, approval process, and the reimbursement for research and development costs and maintenance costs, and potential user fees for such submissions. This rule also clarifies the roles and responsibilities of FCIC and the applicant with respect to the submission. This rule also provides guidelines for non-reinsured supplemental policies to be submitted to FCIC for review in accordance with the SRA.

For submissions approved by the Board prior to publication of this regulation, applicants may either submit documentation of research and development costs or use a formula method to determine the amount of the research and development and maintenance reimbursement. The formula presented in this regulation is an objective measurement using the average number of policies per year earning premium from inception of the product to the time this regulation is published times $7 with the result of this calculation adjusted for scope and complexity, as required by legislation. The $7 was determined by using estimated product development costs with the intent to provide research and development cost reimbursement on an equitable basis considering the sales life cycle to date and market penetration.

Other technical corrections have been made as a result additional review and discussion with the Board.

Hoechst Roussel Vet, Perryville Corporate Park III, P.O. Box 4010, Clinton, NJ 08809-4010, has informed FDA that it has transferred ownership of, and all rights and interest in, the following NADAs and ANADAs to Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE 19966.

Accordingly, the agency is amending the regulations in 21 CFR 520.48, 520.905a, 520.905b, 520.905c, 520.905d, 520.905e, 520.1010a, 520.1010b, 520.1010c, 522.1010, 522.2476, 522.2477, 558.55, 558.58, 558.95, 558.198, 558.258, 558.265, 558.355, 558.363, 558.366, and 558.550 to reflect the transfers of ownership. In addition, the sections in 21 CFR parts 520 and 522 are being revised to reflect current format.

Following the change of sponsor of these NADAs, Hoechst Roussel Vet is no longer the sponsor of any approved applications. Therefore, 21 CFR 510.600(c) is amended to remove the entries for this sponsor.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

1. The authority citation for 21 CFR part 510 continues to read as follows:

2. Section 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications is amended in the table in paragraph (c)(1) by removing the entry for “Hoechst Roussel Vet” and in the table in paragraph (c)(2) by removing the entry for “012799”.

3. The authority citation for 21 CFR part 520 continues to read as follows:

4. Section 520.48 is revised to read as follows:

(a) Specifications. Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest.

(b) Sponsor. See No. 057926 in § 510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Amount. 1.0 mL per 110 pounds body weight (0.044 mg per kilogram) daily for 15 consecutive days.

(2) Indications for use. For suppression of estrus in mares.

(3) Limitations. For oral use in horses only; avoid contact with the skin. Do not administer to horses intended for use as food.

5. Section 520.905a Fenbendazole suspension is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.

6. Section 520.905b Fenbendazole granules is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.

7. Section 520.905c Fenbendazole paste is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.

8. Section 520.905d Fenbendazole powder is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.

9. Section 520.905e Fenbendazole blocks is amended in paragraph (b) by removing “012799” and by adding in its place “057926”.

10. Section 520.1010 is revised to read as follows:

(a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams (mg) furosemide.

(2) Each bolus contains 2 grams (g) furosemide.

(3) Each packet of powder contains 2 g furosemide.

(4) Each milliliter of syrup contains 10 mg furosemide.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use of dosage forms and strengths listed in paragraph (a) of this section for uses as in paragraph (d) of this section.

(1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section.

(2) No. 000093 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(B) of this section.

(3) No. 057926 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and powder in paragraph (a)(3) of this section for conditions of use in paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A).

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use. It is used as follows:

(1) Cattle—(i) Amount. 1 to 2 mg per pound (/lb) body weight using powder, or one 2-g bolus per animal, per day.

(ii) Indications for use. For treatment of physiological parturient edema of the mammary gland and associated structures.

(iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.

(2) Dogs—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.

(ii) Indications for use—(A) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.

(B) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency.

(3) Cats—(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.

(ii) Indications for use. For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.

11. Section 520.1010a Furosemide tablets or boluses is removed.

12. Section 520.1010b Furosemide powder is removed.

13. Section 520.1010c Furosemide syrup is removed.

14. The authority citation for 21 CFR part 522 continues to read as follows:

15. Section 522.1010 is revised to read as follows:

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of furosemide diethanolamine.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 000010 for use as in paragraphs (d)(1) and (d)(2)(ii) of this section.

(2) No. 000864 for use as in paragraph (d)(2)(ii) of this section.

(3) No. 057926 for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Dogs and cats—(i) Amount. 1.25 to 2.5 mg per pound (/lb) body weight once or twice daily, intramuscularly or intravenously.

(ii) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.

(2) Horses—(i) Amount. 250 to 500 mg per animal once or twice daily, intramuscularly or intravenously.

(A) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency, and acute noninflammatory tissue edema.

(B) Limitations. Do not use in horses intended for food.

(ii) Amount. 0.5 mg/lb body weight once or twice daily, intramuscularly or intravenously.

(A) Indications for use. For treatment of acute noninflammatory tissue edema.

(B) Limitations. Do not use in horses intended for food.

(3) Cattle—(i) Amount. 500 mg/animal once daily, intramuscularly or intravenously; or 250 mg/animal twice daily at 12-hour intervals, intramuscularly or intravenously.

(ii) Indications for use. For the treatment of physiological parturient edema of the mammary gland and associated structures.

(iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours (four milkings) after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.

16. Section 522.2476 is revised to read as follows:

(a) [Reserved]

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 021641 for use as in paragraphs (d)(1) and (d)(2) of this section.

(2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(ii), and (d)(2)(iii) of this section.

(c) Related tolerances. See § 556.739 of this chapter.

(d) Conditions of use—(1) Steers fed in confinement for slaughter—(i) Amount. Use 126 days prior to slaughter; should be reimplanted once after 63 days.

(A) 140 milligrams (mg) trenbolone acetate (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.

(B) 140 mg trenbolone acetate (one implant consisting of 8 pellets, each of 7 pellets containing 20 milligrams trenbolone acetate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.

(ii) Indications for use. For improved feed efficiency.

(iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals.

(2) Heifers fed in confinement for slaughter—(i) Amount. Use last 63 days prior to slaughter.

(A) 200 mg trenbolone acetate (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose.

(B) 200 mg of trenbolone acetate (one implant consisting of 11 pellets, each of 10 pellets containing 20 mg of trenbolone acetate, and 1 pellet containing 29 mg of tylosin tartrate) per implant dose.

(ii) Indications for use. For increased rate of weight gain and improved feed efficiency.

(iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals.

17. Section 522.2477 is amended by revising paragraph (b) to read as follows:

Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, has informed FDA that it has transferred ownership of, and all rights and interest in, the following NADAs to Phibro Animal Health, Inc., One Parker Plaza, Fort Lee, NJ 07024:

Accordingly, the agency is amending the regulations in §§ 520.1840, 558.58, 558.115, 558.128, 558.198, 558.311, 558.355, 558.360, 558.435, 558.450, 558.460, 558.465, 558.485, 558.515, 558.550, 558.555, 558.625, and 558.635 (21 CFR 520.1840, 558.58, 558.115, 558.128, 558.198, 558.311, 558.355, 558.360, 558.435, 558.450, 558.460, 558.465, 558.485, 558.515, 558.550, 558.555, 558.625, and 558.635) to reflect the transfer of ownership. In addition, §§ 520.1840 and 558.485 are being revised to reflect current format.

Section 558.450 is also being amended to remove the entries for combination uses of oxytetracycline (OTC) with monensin, provided under NADA 99-066, because they are redundant with entries in § 558.355. The entry for the use of 400 grams per (g/) ton OTC with 90 to 110 g/ton monensin in § 558.450(d)(1)(vi) is an error created during prior revisions (61 FR 51588, Oct. 3, 1996). The correct drug levels, 200 g/ton OTC with 90 to 110 g/ton monensin, for the same indications are codified in § 558.355(f)(1)(viii). The entry for the use of 500 g/ton OTC with 90 to 110 g/ton monensin in § 558.450(d)(1)(vii) is redundant with § 558.355(f)(1)(xxii).

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

1. The authority citation for 21 CFR part 520 continues to read as follows:

(a) Specifications. Polyoxypropylene-polyoxyethylene glycol nonionic block polymer.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 000069 for use as in paragraphs (d)(1) and (d)(3) of this section.

(2) No. 017800 for use as in paragraph (d)(4) of this section.

(3) No. 036904 for use as in paragraph (d)(2) of this section.

(4) No. 066104 for use as in paragraph (d)(3) of this section.

(c) [Reserved]

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

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

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

2. In person. The Agency has established an official record for this action under docket control number OPP-301164. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for the combined residues of the herbicide fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr, free and conjugated, all expressed as fluroxypyr, in or on grass, forage at 120 part per million (ppm), grass, hay at 160 ppm, and modifying the permanent tolerances for milk from 0.1 ppm to 0.30 ppm and for kidney (cattle, goat, hog, horse, and sheep) from 0.5 ppm to 1.5 ppm. These tolerances will expire and are revoked on June 30, 2003. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

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

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

Sericea lespedeza (also known as Chinese bush clover) is a perennial legume native to Asia that was introduced into the United States in 1896 for use as forage for livestock and as an erosion control plant. It was first recognized as a potential weed problem in southeast Kansas in the early 1980s. The Kansas Legislature made sericea lespedeza a statewide noxious weed effective July 1, 2000. It is the first federally listed crop to be declared a noxious weed.

While sericea lespedeza remains a relatively important forage crop in several southeastern states, it has become an invasive weed in tall grass and high plains prairie lands. Sericea aggressively competes with native prairie plants, and can result in a substantial reduction of native grasses and broadleaf plants. Researchers at Emporia State University (Emporia, Kansas) found that the number of grass and forb species in severely infested fields in east-central Kansas declined by 66% and 74% respectively. In a Kansas State University study, native grass production was reduced by as much as 80% when compared to non-infested areas. In addition, sericea lespedeza develops high tannin levels under the low rainfall conditions that exist in Kansas and becomes unpalatable to cattle as it matures. EPA has authorized under FIFRA section 18 the use of fluroxypyr on pastures and rangeland for control of sericea lespedeza in Kansas. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of fluroxypyr in or on grass forage and hay and their associated commodities. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on June 30, 2003, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on grass forage and hay and their associated commodities after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of fluroxypyr and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for combined residues of fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr, free and conjugated, all expressed as fluroxypyr, in or on grass, forage at 120 ppm, grass, hay at 160 ppm, and modifying the permanent tolerances for milk from 0.1 ppm to 0.30 ppm and for kidney (cattle, goat, hog, horse, and sheep) from 0.5 ppm to 1.5 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 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 fluroxypyr used for human risk assessment is shown in the following Table 1:

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

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

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations”, “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301168. 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 December 3, 1997 (62 FR 63942) (FRL-5756-1) EPA issued notices pursuant to section 408 of FFDCA, 21 U.S.C. 346a as amended by FQPA (Public Law 104-170) announcing the filing of pesticide petitions (PP 0E6202 and 1E6249) for tolerances by IR-4, 681 U.S. Highway #1 South, North New Brunswick, NJ 08902 and PP 7F4873 by Valent U.S.A. Corporation, 1333 N. California Blvd., Walnut Creek, California 94596. These notices included summaries of the petitions prepared by Valent U.S.A. Corporation, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.458 be amended by establishing tolerances for combined residues of the herbicide clethodim, [(E)-(±)-2-[1-[[(3-chloro-2-propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one] and its metabolites containing the 5-(2-(ethylthiopropyl)cyclohexene-3-one and 5-(2-(ethylthiopropyl)-5-hydroxycyclohexene-3-one) moieties and their sulphoxides and sulphones, all expressed as clethodim, on various commodities as follows:

(1). PP 1E6249. IR-4 proposed tolerances for green onion and leaf lettuce at 2.0 parts per million (ppm), and Brassica head and stem subgroup at 3.0 ppm.

(2). PP 0E6202. IR-4 proposed tolerance for flax seed and mustard seed at 0.5 ppm and flax meal at 1.0 ppm.

(3). PP 7F4873. Valent U.S.A. Corporation proposed tolerances for canola seed at 0.5 ppm and canola meal at 1.5 ppm. The petition was subsequently amended to propose tolerances for canola seed at 0.5 ppm and canola meal at 1.0 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 these actions. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of clethodim on green onion at 2.0 ppm, leaf lettuce at 2.0 ppm, Brassica head and stem subgroup at 3.0 ppm, flax seed at 0.50 ppm, flax meal at 1.0 ppm, mustard seed at 0.50 ppm, canola seed at 0.50 ppm, and canola meal at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing these 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 clethodim are discussed in Unit III.A. of the Federal Register of March 14, 2001 (66 FR 14829) (FRL-6770-8).

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 (aRfD or cRfD) 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 (MOEcancer= point of departure/exposures) is calculated. A summary of the toxicological endpoints for clethodim used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.458) for the residues of clethodim in or on a variety of food commodities. Recent tolerances established for the residues of clethodim and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones include tuberous and corm vegetables crop subgroup 1c, fruiting vegetables crop group, root vegetables (except sugar beets) crop subgroup 1b, leaves of root and tuber vegetables (excluding sugar beets, crop group 2), sugar beet, tops and sugar beet, molasses at 1.0 ppm, leaf petioles crop subgroup 4b at 0.6 ppm, melon crop subgroup 9a at 2.0 ppm, squash/cucumber crop subgroup 9b and cranberry at 0.5 ppm, sugar beets, roots at 0.20 ppm, sunflower seed at 5.0 ppm, strawberry at 3.0 ppm, sunflower, meal and clover, forage at 10.0 ppm, and clover, hay at 20.0 ppm. Risk assessments were conducted by EPA to assess dietary exposures from clethodim in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a 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.-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 3-day average of consumption for each sub-population is combined with residues to determine average exposure as mg/kg/day. The chronic analysis was performed using tolerance level residues for all crops and livestock commodities. Projected percent crop treated (PCT) data were used for lettuce, broccoli, cauliflower, cabbage, onions, and Brussels sprouts. Weighted average percent of crop treated data were used for certain existing registrations (cotton, onions, peanuts, soybeans, sugar beets, and tomatoes) and 100% crop treated data were used for the remaining new uses and existing uses.

iii. Cancer. Clethodim 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)(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.

The Agency used PCT information for certain registered uses as follows:

• 3% for cotton;

• 8% for onions;

• 3% for peanuts;

• 4% for soybeans;

• 15% for sugar beets, and

• 1% for tomatoes.

The Agency used PCT information for the new uses as follows:

• 2% for lettuce, broccoli and cauliflower;

• 15% for cabbage;

• 25% for onion, and

• 1% for brussels sprouts.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates were derived for the registered uses (cotton, onions, peanuts, soybeans, sugar beets and tomatoes) 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. With respect to the new uses (lettuce, broccoli, cabbage, and onion) the registrant estimated PCT based on percent market share information. The registrant based their projected clethodim PCT for these new uses based on the share of each crop that is treated with registered herbicides that control the same pests. They then projected what part of the market they could capture from those products. The Agency used a similar process for projecting percent of crop treated for Brussels sprouts and cauliflower. The Agency considers the clethodim percent of crop treated projections to be reasonable and conservative.

As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which clethodim may be applied in a particular area.

2. Dietary exposure from drinking water. Surface and ground water contamination may occur from the sulfoxide and sulfone degradates of clethodim, as well as from parent clethodim. However, the risk of water contamination is primarily associated with clethodim sulfone and clethodim sulfoxide rather than parent clethodim based on greater persistence and mobility for the degradates.

The only significant routes of dissipation of clethodim are microbial degradation in soil and movement by leaching or runoff. Parent clethodim is moderately persistent to hydrolysis at pH 5 with half-lives of 26-42 days and stable at pH 7 and 9 with half-lives of greater than 300 days. Even though acceptable water and soil photolysis studies show half-lives of 1.5 to 9.3 days, this may not be an important route of dissipation because of suspended sediment and shading. Photolysis is only an important route of dissipation in shallow, well-mixed surface water with no shading. The half-lives in aerobic soil are 2-3 days for parent clethodim, and 30-38 days for total toxic residues (parent + sulfoxide + sulfone). The sulfoxide and sulfone metabolites are more persistent than parent clethodim and are formed in significant quantities in soil. All residues of clethodim (parent and metabolites) are very mobile in soil with five out of six soil dissorption coefficients (Kd) less than one. The field dissipation studies show that parent clethodim was only found at levels at or near the quantitation limit of 0.02 ppm, which is consistent with the rapid degradation in soil. Clethodim sulfoxide had an apparent half-life of 2.5 to 3.7 days, indicating that movement from the treated field may have been an important route of dissipation.

The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for clethodim in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of clethodim.

The Agency uses the 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 percent referenced dose or percent population adjusted dose. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to clethodim they are further discussed in the aggregate risk sections below. Tier 1 surface water concentrations for parent clethodim and total toxic residues (parent + sulfoxide + sulfone) were estimated using the GENEEC model. Based on the GENEEC model, the peak EECs of clethodim for surface water were estimated to be 24.2 parts per billion (ppb), and 18.3 ppb for chronic exposure. The agency allows for a 3-fold reduction of GENEEC 56-day estimates, which result in a chronic value of 6.1 ppb for surface water. Based on the SCI-GROW model, the EECs of clethodim for ground water were estimated to be 0.49 ppb for acute exposure and 0.08 ppb for chronic exposure.

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

Clethodim is not registered for use on any sites that would result in residential exposure. Based on recently revised clethodim labels, there are no use sites through which homeowners or the public are likely to become exposed to clethodim residues, either directly through application or indirectly by contact with residues on treated surfaces. Therefore, non-occupation exposure assessment was not performed.

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

EPA does not have, at this time, available data to determine whether clethodim has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, clethodim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that clethodim has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

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

3. Conclusion. There is a complete toxicity data base for clethodim and exposure data is complete or is estimated based on data that reasonably account for potential exposures. Based on the above, EPA determined that the 10X safety factor to protect infants and children should be removed.

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 risk. An endpoint for acute dietary exposure was not identified since no effects were observed in oral toxicity studies that could be attributable to a single dose.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to clethodim from food will utilize 30% of the cPAD for the U.S. population, 23% of the cPAD for females (13-50 years old) and 61% of the cPAD for children 1-6 years old. There are no residential uses for clethodim that result in chronic residential exposure to clethodim. In addition, there is potential for chronic dietary exposure to clethodim in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2:

3. Short-term 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).

Clethodim 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. Clethodim 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, clethodim 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 clethodim residues.

Method RM-26A-1, a gas-liquid chromatographic (GLC) procedure, was validated for the analyses of residues of clethodim sulfoxide and its metabolite (5-OH clethodim sulfone) in/on flax at fortification levels of 0.05 ppm and 0.5 ppm, and on canola at a fortification level of 0.2 ppm. Method RM-26A-1 can determine all clethodim metabolites retaining the cyclohex-1-one moiety (DME and DME-OH). The Method RM-26A-1 for the determination of clethodim and its metabolites in mustard, seed and flax is acceptable for data collection.

Method RM-26B-2 was validated for the analyses of residues of clethodim sulfoxide and its metabolite (5-OH clethodim sulfone) in/on broccoli. The fortification levels for clethodim sulfoxide and 5-OH-clethodim sulfone were each 0.05 ppm, 1.0 ppm and 2.0 ppm. Recoveries of residues of clethodim sulfoxide in broccoli were within the acceptable range at the fortification level of 0.05 ppm. Recoveries of residues of 5-OH-clethodim sulfone in broccoli were within the acceptable range at fortification levels of 0.05, 1.0 and 2.0 ppm. Recoveries of residues of clethodim sulfoxide in broccoli were low at the fortification levels of 1.0 and 2.0 ppm. The Method RM-26B-2 for the determination of clethodim and its metabolites in broccoli is acceptable for data collection and enforcement purposes.

Method RM-26B-3 (a modification of RM-26B-2) was validated for the analyses of residues of clethodim sulfoxide and its metabolite (5-OH clethodim sulfone) in/on green onions, leaf lettuce, and cabbage. The fortification levels for clethodim sulfoxide and 5-OH clethodim sulfone were 0.11 ppm - 2.0 ppm for green onions, 0.11 ppm - 0.91 ppm for leaf lettuce, 0.11 ppm - 1.1 ppm for cabbage. Recoveries of residues of clethodim sulfoxide in green onions, leaf lettuce, and cabbage were within the acceptable range at all fortification levels tested. Recoveries of residues of 5-OH-clethodim sulfone were within the acceptable range except for low recoveries in green onions fortified at 2.0 ppm and cabbage fortified at 0.77 and 0.98 ppm. The Method RM-26B-3 for the determination of clethodim and its metabolites in green onions, leaf lettuce, and cabbage is acceptable for data collection.

The common moiety Method RM-26B-3 for the determination of clethodim and its metabolites is similar to the common moiety Method RM-26B-2. The Method RM-26B-2 has previously undergone a successful Petition Method Validation by the Agency. Method RM-26B-2 as an enforcement method and Method RM-26B-3 as a letter method have been forwarded to FDA for inclusion in PAM II.

Livestock feed items are associated with canola and flax seed uses. The Agency has previously concluded that adequate analytical methodology is available to enforce tolerances for residues of clethodim in livestock commodities. The compound specific method, EPA-RM-26D-2, is suitable for enforcement of tolerances for total clethodim residues in crops and livestock tissues, and it has been forwarded to FDA for publication in the Pesticide Analytical Manual, Volume II (PAM II). The common moiety method, RM-26B-2, serves as the enforcement method for milk as RM-26D-2 and is not quantitative for residues in milk.

The Methods may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort George G. Mead, Maryland, 20755-5350; telephone number: (410) 305-2905; e-mail address: griffith.francis@epa.gov.

There are no established Codex maximum residue limits (MRLs) for residues of clethodim in/on the commodities discussed in the subject petition; therefore, there are no questions with respect to Codex/U.S. tolerance compatibility. Codex MRLs are currently established on various crop and livestock commodities in terms of the sum of clethodim and its metabolites containing 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, expressed as clethodim. There are established Canadian residue limits for clethodim residues and its metabolites containing the 2-cyclohex-1-enone moiety on mustard, seed at 0.4 ppm, on flax at 0.3 ppm and on canola at 0.5 ppm. However, based on the submitted residue data, HED can not harmonize the tolerances of flax and mustard, seed with Canadian residue limits.

The registration for the use of clethodim on leaf lettuce will be made conditional based upon the need for additional crop field trial data for clethodim on leaf lettuce. The registration for use of clethodim on canola and flax will be made conditional based upon the requirement for a canola processing study.

Therefore, tolerances are established for combined residues of clethodim, [[(E)-(±)-2-[1-[[(3-chloro-2-propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one] and its metabolites containing the 5-(2-(ethylthiopropyl)cyclohexene-3-one and 5-(2-(ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones], in or on green onion at 2.0 ppm, leaf lettuce at 2.0 ppm, brassica head and stem subgroup at 3.0 ppm, flax seed at 0.50 ppm, flax meal at 1.0 ppm, mustard seed at 0.50 ppm, canola seed at 0.50 ppm, and canola meal at 1.0 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 control number OPP-301168 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 16, 2001.

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 control number OPP-301168, 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 as required 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 theFederal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301171. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of June 23, 1998 (63 FR 34176) (FRL-5795-1), and September 8, 1999 (64 FR 48829) FRL-6097-6), EPA issued notices under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a announcing the filing of pesticide petitions (PP) (PF 813 and PF 888) for tolerances by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103.

These notices included a summary of the petition prepared by FMC Corporation, the registrant. There were no comments received in response to these notices of filing.

The petitions requested that 40 CFR 180.418 be amended by establishing a tolerance for residues of the insecticide zeta-cypermethrin, in or on the following raw agricultural commodities:

1. PP 9F6040 proposed a tolerance for rice, grain at 1.2 parts per million (ppm), rice, straw at 2.0 ppm and rice, hulls at 16.0 ppm. Based on EPA's review of processing studies, the petition was revised by the petitioner to propose a tolerance of 1.5 ppm on rice grain and 6.0 ppm on rice hulls.

2. PP 8F4970 proposed a tolerance for leafy vegetables (except Brassica vegetables) group (Crop Group 4) at 10.0 ppm, Brassica, head and stem (Crop Group 5A) at 2.0 ppm and Brassica, leafy (Crop Group 5B) at 14.0 ppm. These tolerances as proposed are adequate.

3. PP 9F3067 proposed a tolerance for sugar beets, roots at 0.05 ppm, and sugar beets, tops at 0.20 ppm; sugarcane at 0.60 ppm; corn, grain (field, seed and pop) at 0.05 ppm; green onions at 6.0 ppm; alfalfa seed at 0.5 ppm, alfalfa forage at 10.0 ppm, and alfalfa hay at 30.0 ppm; and corn, sweet (K + CWHR) at 0.1 ppm, corn, forage and corn, fodder at 30.0 ppm; poultry, meat at 0.05 ppm, poultry, meat by-products at 0.05 ppm, poultry, fat at 0.05 ppm and eggs at 0.05 ppm; meat of cattle, goats, hogs, horses, and sheep at 0.3 ppm; fat of cattle, goats, hogs, horses, and sheep at 2.0 ppm; and milk, fat at 1.0 ppm (reflecting 0.2 ppm in whole milk). Based on EPA's review of the field residue and animal feeding data the petition was revised by the petitioner to:

a. Propose tolerances of 0.05 ppm for sweet corn (K + CWHR) and 15 ppm for sweet corn forage and stover. (Note that stover is the correct term instead of fodder).

b. Propose separate tolerance for field corn grain and pop corn grain at 0.05 ppm.

c. Delete the proposed seed corn tolerance since it is covered by field corn.

d. Propose separate tolerances for field corn stover and pop corn stover at 3.0 ppm and field corn forage at 0.20 ppm.

e. Reduce the proposed 6.0 ppm tolerance on green onion to 3.0 ppm.

f. Propose the following livestock commodity tolerances as a result of the increased dietary burden: animal (cattle, goat, hog, horse, sheep) meat at 0.1 ppm; fat at 1.0 ppm; and milk fat at 2.5 ppm (reflecting 0.10 ppm in whole milk).

g. Propose tolerances for alfalfa seed, forage and hay, respectively at 0.5 ppm, 5 ppm, and 15 ppm.

Based upon the isomer composition of zeta-cypermethrin with four insecticidally less active ones at a concentration of 1% each, EPA is proposing the current tolerance expression be revised by adding the phrase and its inactive R-isomers after the chemical name.

Although EPA had requested a number of changes to the initial petitions and Notice of Filings, the nature of the changes, i.e. reduction in tolerance levels, clarification and correction of commodity terms are not considered significant nor do they alter the risk assessment. Therefore EPA is issuing this as a final action.

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 zeta-cypermethrin and its inactive R-isomers in or on alfalfa, hay at 15 parts per million (ppm), alfalfa, forage at 5.0 ppm, alfalfa, seed at 0.5 ppm; beets, sugar, roots at 0.05 ppm, beets, sugar, tops at 0.20 ppm; corn, field, grain at 0.05 ppm, corn, pop, grain at 0.05 ppm, corn, field, forage at 0.20 ppm, corn, field, stover at 3.0 ppm, corn, pop, stover at 3.0 ppm, corn, sweet, (K + CWHR) at 0.05 ppm, corn, sweet, forage at 15 ppm, corn, sweet, stover at 15 ppm; onions, green at 3.0 ppm; leafy vegetables except Brassica at 10 ppm, head and stem Brassica at 2.0 ppm, leafy Brassica at 14 ppm; sugarcane at 0.6 ppm; rice, grain at 1.5 ppm, rice, hulls at 6.0 ppm; rice, straw at 2.0 ppp; fat of cattle, goat, horse, sheep, hogs at 1.0 ppm, meat of cattle, goat, horse, sheep, hogs 0.1 ppm, milk, fat at 2.5 ppm (reflecting 0.10 ppm in whole milk), poultry, fat at 0.05 ppm, poultry, meat at 0.05 ppm, poultry, meat by-products at 0.05 ppm; and eggs 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 zeta-cypermethrin and its inactive R-isomers 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. Zeta-cypermethrin is an enriched isomer of cypermethrin. In order to select toxicity endpoints for the purposes of risk assessment, bridging data on zeta-cypermethrin were submitted so that the toxicity of zeta-cypermethrin could be compared with that of cypermethrin and the data bases could be combined to form one complete data base for both chemicals. In the selection of toxicity endpoints, studies conducted with zeta-cypermethrin were used wherever possible. When an endpoint was selected using a study conducted with cypermethrin, a rationale was provided on why this particular endpoint was protective for exposure to zeta-cypermethrin.

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 (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for zeta-cypermethrin and its inactive R-isomers 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 180.418) for the residues of zeta-cypermethrin, in or on a variety of raw agricultural commodities: Cabbage at 2.0 ppm, animal fat (cattle, goat, hog, horse, and sheep) at 0.05 ppm, animal meat by-products at 0.05 ppm, animal meat at 0.05 ppm, cottonseed at 0.5 ppm, head lettuce at 10.0 ppm, milk at 0.05 ppm, bulb onions at 0.10 ppm, and pecans at 0.05 ppm. Tolerances for cypermethrin (parent compound) are the same as those for zeta-cypermethrin with the exception that there are cypermethrin tolerances for green onions at 6.0 ppm, heads and stem Brassica at 2.0 ppm and leafy Brassica at 14.0 ppm. Risk assessments were conducted by EPA to assess dietary exposures from zeta-cypermethrin and its inactive R-isomers in food as follows:

Zeta-cypermethrin is an enriched-enantiomer version of the insecticide cypermethrin. Both cypermethrin and zeta-cypermethrin are mixtures of eight isomers, with the active components consisting of the S-enantiomers (“S”configuration at the cyano bearing carbon). The two differ in that cypermethrin has a 50:50 R/S ratio whereas zeta-cypermethrin is enriched in the S-enantiomers with a ratio of 90:10 of S/R. The enriched isomer formulation provides for similar insect control but at lower use rates. Since use of both cypermethrin and zeta-cypermethrin result in human exposure to the same eight isomers, dietary and non-dietary (residential) aggregate risk assessment was conducted by adding the uses of the two chemicals.

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 (DEEMTM) 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: Tolerance-level residues and 100% crop treated have been used in these analyses for all commodities having either established or proposed tolerances of cypermethrin or zeta-cypermethrin. In cases where a commodity has an established tolerance for cypermethrin and a proposed tolerance for zeta-cypermethrin, the larger of the two values was used in the assessment. DEEMTM default processing factors were used for all commodities in this assessment.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEMTM 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: Tolerance-level residues and 100% crop treated have been used in these analyses for all commodities having either established or proposed tolerances of cypermethrin or zeta-cypermethrin. For chronic risk assessments, residue estimates for foods (e.g., apples) or food-forms (e.g., apple juice) of interest are multiplied by the averaged consumption estimate of each food/food-form of each population subgroup. Exposure estimates are expressed in mg/kg bwt/day and as a percent of the cPAD.

As shown by the summarized acute and chronic results in Tables 4 and 5, all risk estimates fall below EPA's level of concern (≥100% PAD). All exposures are Tier 1 estimates that are extremely conservative and likely overestimate actual dietary exposure. Refinements to the analyses in the form of percent crop treated considerations and/or anticipated residues would likely reduce the exposure and risk estimates for zeta-cypermethrin.

iii. Cancer. Cypermethrin has been classified as a Category C, possible human carcinogen, based on an increased incidence of lung adenomas and adenomas plus carcinomas combined in female mice (Cancer Peer Review Committee, 1988). The evidence was not considered strong enough to warrant a quantitative estimation of human risk. Cypermethrin has not been classified under the more current, Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996). Because zeta-cypermethrin is an enriched isomer of cypermethrin, it is also classified as a Category C carcinogen and a RfD approach was recommended for human risk assessment purposes.

2. Dietary exposure from drinking water. Based on the available data, cypermethrin/zeta-cypermethrin is a moderately persistent chemical that primarily degrades by photolysis in water and biodegradation. Depending on the environmental circumstances, it may persist for periods of months post-treatment. Cypermethrin is tightly bound to soil particles and is not likely to move to ground waters. However, the degradate DCVA is mobile and likely to reach ground waters. Additional information about the mobility of this degradate has been requested. Cypermethrin can contaminate surface waters through spray drift. Under some conditions it may also have a potential for runoff into surface waters (primarily through erosion), for several months post-application. Since zeta-cypermethrin is preferentially associated to the soils, the fraction of the chemical in the water column should be small. In addition, it is expected that treatment of drinking waters would remove substantial portions of cypermethrin/zeta-cypermethrin present in water. Although the Agency has not addressed residues of DCVA in water, we have concluded that DCVA does not need to be included in the dietary risk for food.

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 ground water. For a screening-level assessment for surface water, EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a 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 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 cypermethrin and zeta-cypermethrin and its inactive R-isomers, they are further discussed in the aggregate risk sections below.

Based on the FIRST and SCI-GROW models, the EECs of cypermethrin and zeta-cypermethrin and its inactive R-isomers for acute exposures are estimated to be 8.9 parts per billion (ppb) for surface water and 0.006 ppb for ground water. The EECs for chronic exposures are estimated to be 0.46 ppb ppb for surface water and 0.006 ppb for ground water. These values generally represent upper-bound estimates of the concentrations that might be found in surface water and ground water due to the use of cypermethrin on Brassica vegetables, which has the highest application rate among both cypermethrin and zeta-cypermethrin on all crops over which the chemicals are applied.

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).

Zeta-cypermethrin and its inactive R-isomers is not registered for use on any sites that would result in residential exposure. However, cypermethrin does have indoor and outdoor residential uses (zeta-cypermethrin is an enriched-enantiomer version of the insecticide cypermethrin). The analytical method does not distinguish cypermethrin from zeta-cypermethrin, and the toxicological endpoints are the same. Therefore, dietary and non-dietary residential aggregate risk assessment is conducted by adding the uses of the two chemicals.

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

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

ii. Prenatal and postnatal sensitivity. The data demonstrated no indication of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to either zeta-cypermethrin or cypermethrin. In the prenatal developmental toxicity studies in rats, there was no evidence of developmental toxicity at the highest dose tested (35 mg/kg/day). Maternal toxicity (decreased body weight gain (both chemicals), and food consumption, ataxia, urine and feces-stained for (zeta-cypermethrin)) was observed at the LOAEL of 25 mg/kg/day. The maternal NOAELs were established at 12.5 mg/kg/day for zeta-cypermethrin and 17.5 mg/kg/day for cypermethrin. In the definitive rabbit developmental toxicity study conducted with cypermethrin, the maternal LOAEL was 450 mg/kg/day based on decreased body weight gain. No developmental toxicity was observed at dose levels up to 700 mg/kg/day. In the two-generation reproduction study in rats conducted with zeta-cypermethrin, offspring toxicity (decreased pup weight gain during lactation) was observed at the same treatment level which resulted in parental systemic toxicity (NOAEL: 27 mg/kg/day; LOAEL: 45 mg/kg/day). In the definitive multigeneration reproduction study conducted with cypermethrin, the parental NOAEL/LOAEL is lower than the pup NOAEL/LOAEL, both based on decreases in body weight gain (2.5/7.5 mg/kg/day for the parents versus 7.5/37.5 mg/kg/day for the pups).

iii. Conclusion. There is a complete toxicity data base for zeta-cypermethrin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposure based on the considerations above. The safety factor can be removed for zeta-cypermethrin and its inactive R-isomers because: (1) There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure; (2) the requirement of a developmental neurotoxicity study is not based on criteria reflecting special concern for the developing fetuses or young which are generally used for requiring a DNT study - and a safety factor (e.g., neuropathy in adult animals; CNS malformations following prenatal exposure; brain weight or sexual maturation changes in offspring; and/or functional changes in offspring) and therefore does not warrant an FQPA safety factor; and (3) the dietary (food and drinking water) and non-dietary 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 risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to zeta- cypermethrin and its inactive R-isomers will occupy 20% of the aPAD for the U.S. population, 20% of the aPAD for females 13 years and older, 22% of the aPAD for infants (<1 year old), and 30% of the aPAD for children (1-6 years). In addition, there is potential for acute dietary exposure to zeta-cypermethrin and its inactive R-isomers 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 6:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to zeta- cypermethrin and its inactive R-isomers from food will utilize 11% of the cPAD for the U.S. population, 10% of the cPAD for all infants (< 1 year old), and 20% of the cPAD for children (1-6 years old).

There are no residential uses for zeta-cypermethrin and its inactive R-isomers that result in chronic residential exposure to zeta-cypermethrin and its inactive R-isomers. However, cypermethrin does have indoor and outdoor residential uses (zeta-cypermethrin is an enriched-enantiomer version of the insecticide cypermethrin). The analytical method does not distinguish cypermethrin from zeta-cypermethrin, and the toxicological endpoints are the same. Therefore, dietary and non-dietary residential aggregate risk assessment is conducted by adding the uses of the two chemicals. Based on the use pattern, chronic residential exposure to residues of zeta-cypermethrin and its inactive R-isomers is not expected. In addition, there is potential for chronic dietary exposure to zeta-cypermethrin and its inactive R-isomers 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 7:

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).

Zeta-cypermethrin and its inactive R-isomers is currently not registered for use that could result in short-term residential exposure; however, cypermethrin does have indoor and outdoor residential uses (zeta-cypermethrin is an enriched-enantiomer version of the insecticide cypermethrin). Cypermethrin registered residential uses constitute short- and intermediate-term exposure scenarios; endpoints have been selected for short- and intermediate-term incidental oral and inhalation exposures, and the acceptable MOEs for short- and intermediate-term exposures are 100. Since the toxicological effects through the inhalation exposure route are similar to those toxicological effects through the oral routes, short-term aggregate risk assessment was conducted adding inhalation, oral non-dietary exposure, and average food and water exposure.

Since all the acceptable MOEs are at the same level, the aggregate risks for population subgroups can be estimated by calculating aggregate Margin of Exposure values (MOEaggregate).

where I = inhalation, D = dermal (no dermal endpoints was selected for zeta-cypermethrin), O = non-dietary oral, MOEfood = average food from the chronic DEEM run.

As residue values in water from monitoring data are not available, therefore, as with the acute dietary aggregate risk estimate, for the short- and intermediate-term aggregate risk assessments, the DWLOCs have to be back calculated.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,500 for adult males, 1,700 for adult females, 830 for a child, and 1,700 for infants. 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 zeta-cypermethrin and its inactive R-isomers 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 8:

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).

Zeta-cypermethrin and its inactive R-isomers is currently not registered for use that could result in intermediate-term residential exposure; however, cypermethrin does have indoor and outdoor residential uses (zeta-cypermethrin is an enriched-enantiomer version of the insecticide cypermethrin). Cypermethrin registered residential uses constitute short- and intermediate-term exposure scenarios; endpoints have been selected for short- and intermediate-term incidental oral and inhalation exposures, and the acceptable MOEs for short- and intermediate-term exposures are 100. Since the toxicological effects through the inhalation exposure route are similar to those toxicological effects through the oral routes, short-term aggregate risk assessment was conducted adding inhalation, oral non-dietary exposure, and average food and water exposure.

Since all the acceptable MOEs are at the same level, the aggregate risks for population subgroups can be estimated by calculating aggregate Margin of Exposure values (MOEaggregate).

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 760 for adult males, 860 for adult females, 350 for a child and 600 for infants. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of zeta-cypermethrin and its inactive R-isomers in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 9:

5. Aggregate cancer risk for U.S. population. Cypermethrin/zeta-cypermethrin has been classified as a Category C carcinogen, based on an increased incidence of lung adenomas and adenomas plus carcinomas combined in female mice. However, the evidence was not considered strong enough to warrant a quantitative estimation of human risk. An RfD approach was recommended for human risk assessment purposes. Dietary risk concerns due to long-term consumption of zeta-cypermethrin are adequately addressed in the chronic exposure analysis. For the U.S. population only 11% of RfD is occupied by chronic food and water exposure.

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 zeta-cypermethrin and its inactive R-isomers residues.

Adequate enforcement methods are available for determination of cypermethrin residues in plants and animal products in PAM II (Method I). This method involves initial acetone-hexane extraction, followed by partitioning with water. The organic layer is evaporated, then redissolved in cyclohexane-methylene chloride and passed through a gel permeation column. The eluate is evaporated, redissolved in hexane and passed through a Florisil column. Cypermethrin residues are analyzed by gas chromatography (GC) with an electron capture detector (ECD). Since zeta-cypermethrin is an isomer enriched form of cypermethrin, and the PAM II method is not stereospecific, this method is considered adequate for enforcement of the proposed tolerances of zeta-cypermethrin.

1. Current status indicates that a Codex maximum residue level (MRL) of 0.05 ppm for residues of cypermethrin has been established for sweet corn (corn-on-the-cob). Based on zeta-cypermethrin residues observed in sweet corn ears in the U.S. field trials, the sweet corn tolerance for zeta-cypermethrin is lowered to 0.05 ppm to achieve harmonization with Codex. No Codex MRLs have been established for sweet corn forage/fodder. Canadian or Mexican MRLs have not been established for residues of cypermethrin in/on sweet corn ears or forage/fodder.

2. Current status indicates that Codex, Canadian, or Mexican MRLs have been established for residues of zeta-cypermethrin (or cypermethrin) in/on alfalfa forage (5 ppm), maize (0.05 ppm), maize fodder (5 ppm), bulb onion (0.1 ppm), root and tuber vegetables (0.05 ppm), sweet corn on the cob (0.05 ppm), and vegetable oils (0.5 ppm). The recommended tolerances will be the same as the international tolerances for maize (as applied to field, seed, and pop corn), bulb onions, and root and tuber vegetables (applied to sugar beets). The U.S. field corn fodder tolerance will be lower than the maize fodder tolerance; however, it is unlikely that maize fodder will be shipped to the U.S. In addition, if it were imported, from a practical enforcement perspective, the higher tolerance needed for sweet corn stover (15 ppm; PP 4F3012) would likely apply. Since there is no processed food tolerance for corn oil, the field corn grain tolerance of 0.05 ppm would apply. The international tolerance for vegetable oils is much higher (0.5 ppm) and cannot be harmonized with the U.S. tolerance as the later would have to be set much higher than necessary.

3. Current status indicates that no Codex, Canadian, or Mexican MRLs have been established for residues of zeta-cypermethrin in/on rice.

4. Current status indicates that a Codex MRL of 2 ppm for residues of cypermethrin (racemic) has been established for head lettuce and 1 ppm for Brassica vegetables. This is inconsistent with the proposed U.S. tolerance of 10.0 ppm for zeta-cypermethrin for Crop Group 4 (leafy vegetables except Brassica), 2.0 ppm for Crop Group 5A (head and stem Brassica), and 14.0 ppm for Crop Group 5B (leafy Brassica). Harmonization of U.S. tolerances with Codex tolerances is not possible because at the proposed maximal use rates, residues greater than the Codex MRLs were found in the U.S. field trials. No Mexican MRLs have been established for residues of cypermethrin or zeta-cypermethrin in any relevant crop, but Canada has established cypermethrin MRLs of 1.0 ppm for celery and 0.5 ppm for broccoli, cabbage, cauliflower, and Brussels sprouts.

Therefore, the tolerances are established for residues of zeta-cypermethrin and its inactive R-isomers in or on alfalfa, hay at 15 ppm, alfalfa, forage at 5.0 ppm, alfalfa, seed at 0.5 ppm; beets, sugar, roots at 0.05 ppm, beets, sugar, tops at 0.20 ppm; corn, field, grain at 0.05 ppm, corn, pop, grain at 0.05 ppm, corn, field, forage at 0.20 ppm, corn, field, stover at 3.0 ppm, corn, pop, stover at 3.0 ppm, corn, sweet, (K + CWHR) at 0.05 ppm, corn, sweet, forage at 15 ppm, corn, sweet, stover at 15 ppm; onions, green at 3.0 ppm; leafy vegetables except Brassica at 10 ppm, head and stem Brassica at 2.0 ppm, leafy Brassica at 14 ppm; sugarcane at 0.6 ppm; rice, grain at 1.5 ppm, rice, straw at 2.0 ppm, rice, hulls at 6.0 ppm; fat of cattle, goat, horse, sheep, hogs at 1.0 ppm; meat of cattle, goat, horse, sheep, hogs at 0.1 ppm; milk, fat at 2.5 ppm (reflecting 0.10 ppm in whole milk); poultry, fat at 0.05 ppm, poultry, meat at 0.05 ppm, poultry, meat by-products at 0.05 ppm; and eggs at 0.05 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301171 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 16, 2001.

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 control number OPP-301171, 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 other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). 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 theFederal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301170. 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 52746) (FRL-6739-4), 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) 9F05044, 9E06005, and 9E06057 for tolerances by IR-4, Technology Centre of New Jersey, 681 US Highway #1 South, North Brunswick, NJ 08902-3390. These notices included summaries of the petitions prepared by Novartis Crop Protection, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR part 180 be amended by establishing tolerances for combined residues of the fungicide mefenoxam, (R)- and (S)-2-[(2,6-dimethylphenyl)-methoxyacetylamino]-propionic acid methyl ester, its metabolites containing the 2,6-dimethylaniline moiety, and N-(2-hydroxymethyl-6-methylphenyl)-N-(methoxyacetyl)alanine methyl ester, each expressed as mefenoxam equivalents, in or on fresh herb subgroup at 5 part per million (ppm); dried herb subgroup at 30 ppm; fresh mint at 5 ppm; kiwifruit at 0.05 ppm; atemoya, globe artichoke, starfruit, sugar apple, sweepsop, and true custard at 0.1 ppm; papaya, black sapote, caimito, canistel, mamey sapote, mango, and sapodilla at 0.3 ppm; and lingonberry at 1.0 ppm. IR-4 subsequently revised the petitions, deleting tolerances for mint, sweepsop, and caimito; and changing tolerances for fresh herb from 5.0 ppm to 8.0 ppm; dried herb from 30 ppm to 55 ppm; kiwifruit from 0.05 ppm to 0.10 ppm; globe artichoke from 0.1 ppm to 0.05 ppm; atemoya, starfruit, sugar apple, and custard apple from 0.1 ppm to 0.20 ppm; papaya, black sapote, canistel, mamey sapote, mango, and sapodilla from 0.3 ppm to 0.40 ppm; and lingonberry from 1.0 ppm to 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 these actions. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of mefenoxam on globe artichoke at 0.05 ppm, starfruit at 0.20 ppm, kiwifruit at 0.10 ppm, papaya at 0.40 ppm, black sapote at 0.40 ppm, star apple at 0.40 ppm, canistel at 0.40 ppm, mamey sapote at 0.40 ppm, mango at 0.40 ppm, sapodilla at 0.40 ppm, sugar apple at 0.20 ppm, atemoya at 0.20 ppm, custard apple at 0.20 ppm, lingonberry at 2.0 ppm, fresh herbs at 8.0 ppm, and dried herbs at 55 ppm. EPA's assessment of exposures and risks associated with establishing these 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 mefenoxam 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. Metalaxyl is the racemic mixture of the R- and S- enantiomers; mefenoxam is the R-enantiomer. Metalaxyl has an extensive toxicity data base and a Reregistration Eligibility Decision document was completed in September 1994. Data have been accepted by EPA which bridge the necessary environmental fate, chemistry, and toxicology studies from metalaxyl to mefenoxam. The structural similarities between mefenoxam and metalaxyl are the basis for bridging data between the two active ingredients. Mefenoxam and metalaxyl have the same empirical formula, and being optical isomers, differ only in the spatial arrangement of atoms in their structure. Both the R and S enantiomers are considered residues of concern for both chemicals.

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 (aRfD or cRfD) 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 (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for mefenoxam used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses. A time-limited tolerance has been established (40 CFR 180.546) for the combined residues of mefenoxam, in or on canola (expires December 31, 2001). No other tolerances have been established for mefenoxam per se. Since metalaxyl is the racemic mixture of the R- and S- enantiomers; the risk assessment performed for the proposed new uses of mefenoxam includes all current metalaxyl tolerances/uses. Tolerances have been established (40 CFR 180.408) for metalaxyl on various raw agricultural commodities and animal commodities. Tolerances have been established for metalaxyl and its metabolites containing the 2,6-dimethylaniline moiety, and N-(2-hydroxymethyl-6-methylphenyl)-N-(methoxyacetyl)-alanine methyl ester, each expressed as metalaxyl equivalents, at 0.4 ppm in the fat, kidney, and liver of cattle, goats, hogs, horses, poultry, and sheep; 0.05 ppm in meat and meat byproducts (except kidney and liver) of cattle, goats, hogs, horses, poultry, and sheep; 0.02 ppm in milk, and 0.05 ppm in eggs. Risk assessments were conducted by EPA to assess dietary exposures from mefenoxam 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 dietary risk assessment was not preformed for mefenoxam since an endpoint of concern was not identified during the review of the available 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 1994-1996 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: Since metalaxyl and mefenoxam share the same residues of concern, the chronic dietary exposure assessment was performed using established metalaxyl tolerances in addition to the proposed tolerances for mefenoxam. The chronic dietary analysis used residue values at the established and recommended tolerance levels, and assumed that 100 percent of the registered and proposed crops were treated. This Tier 1 chronic dietary analysis should be considered highly conservative.

iii. Cancer. Metalaxyl 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, based on the classification of metalaxyl, mefenoxam is also considered “not likely to be a human carcinogen.”

2. Dietary exposure from drinking water. Sufficient acceptable bridging data have been submitted to verify that the environmental fate of mefenoxam is similar to that of metalaxyl. Therefore, based on the bridging data submitted (soil photolysis, aerobic soil metabolism and batch equilibrium and column leaching studies), EPA can conclude that environmental fate studies of metalaxyl, including the reviewed studies on mefenoxam, can be used to predict the environmental fate of mefenoxam. Metalaxyl was found to be moderately stable under normal environmental conditions; its degradates are mobile in sandy soils and those low in organic matter. EPA has determined that residues of metalaxyl and mefenoxam and their metabolites N-(2,6-dimethylphenyl)-N-(methoxyacetyl)alanine (CGA-62826), each expressed as parent equivalents, should be included in the drinking water assessment.

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

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

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

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a Percent of the Reference Dose (%RfD) or Percent of the Population Adjusted Dose (%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 mefenoxam they are further discussed in the aggregate risk sections below.

The first-tier screening model GENEEC was used to estimate potential surface water concentrations, and the screening model SCI-GROW was used to estimate potential ground water concentrations. The maximum annual lingonberry application rate of 5.4 lb a.i./acre (2.7 ai/acre twice) was used to model mefenoxam concentrations in drinking water. The GENEEC simulation of the lingonberry use predicts an acute concentration of 180 ppb, and a 90-day chronic concentration of 109 ppb. SCI-GROW modeling simulated mefenoxam concentrations in ground water of 13.5 ppb for this proposed use. For the degradate of concern, CGA-62826, GENEEC modeling results in estimates of 198 ppb for acute exposure and 194 ppb for chronic exposure, with limited environmental fate data. The predicted SCI-GROW concentration for this degradate is 37 ppb in ground water. The combined (parent plus metabolite) EEC values are 101 ppb (109 ppb for parent + 194 ppb for degradate/3) for chronic surface water and 51 ppb (13.5 ppb for parent and 37 ppb for degradate) 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).

Mefenoxam is currently registered for use on the residential non-dietary site turf. Risk assessments were conducted using the following residential exposure assumptions: Residential handler exposure has been assessed for two formulations of mefenoxam: an emulsifiable concentrate, (1) Subdue® MAXX® EC, and (2) a granular, Subdue® MAXX® GR both used at a maximum rate of 0.015 lb ai/1,000 ft2. Non-occupational (residential) handlers may be exposed during mixing, loading and application of mefenoxam using a variety of application methods for short-term durations (1-7 days) based on the mefenoxam turf use. Continuous exposure over intermediate-term (7 days to several months) or long-term (several months or more) time periods are not expected. Dermal exposure was not assessed because applicable endpoints were not identified. MOEs for inhalation exposure from non-occupational handler scenarios were above the target of 100, and thus do not exceed EPA's level of concern.

Non-occupational postapplication exposures were also assessed for Subdue® MAXX® EC (46.6%) and Subdue® MAXX® GR (0.97%), two major mefenoxam products on turf which are considered to represent the reasonable upper bound residential exposure potential. Adults and children may be exposed to mefenoxam residues following treatment of residential areas. However, postapplication exposure is limited to incidental oral exposure, since post application inhalation exposure is expected to be negligible and endpoints were not identified for short- or intermediate-term dermal risk assessment. Postapplication exposure assessments were performed for toddler's incidental ingestion of residues of mefenoxam on treated turf (hand-to-mouth, object-to-mouth) and ingestion of granules. MOEs for oral exposure to toddlers were all above 100 and thus do not exceed EPA's level of concern. Also, combined exposure from toddler's incidental ingestion of mefenoxam residues on treated turf and from object-to-mouth exposure from treated turfgrass and soil results in short-term MOEs that are greater than 100 and do not exceed 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 mefenoxam 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, mefenoxam 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 mefenoxam 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. Conclusion. There is a complete toxicity data base for mefenoxam and exposure data are complete or are estimated based on data that reasonably account for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because (1) there is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure, (2) a developmental neurotoxicity study is not required at this time, and (3) the dietary (food and drinking water) and non-dietary 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, the Office of Pesticide Programs (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. Therefore, an acute aggregate risk assessment was not performed.

2. Chronic risk. EPA determined that the parent, mefenoxam, and the metabolite N-(2,6-dimethylphenyl)-N-(methoxyacetyl)alanine (CGA-62826), each expressed as parent equivalents, should be included in the drinking water assessment. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to mefenoxam from food will utilize 17% of the cPAD for the U.S. population, 36% of the cPAD for children 1-6 years old and 14% of the cPAD for females 13-50 years old. Based on the use pattern, chronic residential exposure to residues of mefenoxam is not expected. In addition, there is potential for chronic dietary exposure to mefenoxam 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 and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Mefenoxam 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 mefenoxam.

Short-term and intermediate aggregate risks from mefenoxam were calculated based on exposures from the oral and inhalation routes of exposure. Inhalation exposure was assessed for the adult, residential pesticide handler only. Postapplication, inhalation exposure to the adult handler is not considered a significant route of exposure. Incidental oral risk was assessed for the postapplication exposure of toddlers in the home environment only. Dermal toxicity endpoints were not chosen for this chemical and thus an assessment of the dermal route of exposure was not performed.

Short- and intermediate-term daily doses from the hand-to-mouth, turfgrass, and soil ingestion pathways were combined and represent the residential exposure potential for toddlers, represented as children 1 to 6 years old. Short- and intermediate-term inhalation values from the residential activity which resulted in the greatest exposure, were used to calculate residential exposures to adult home applicators. In all cases, the residential exposures described above were added to the average food exposures to develop the aggregate exposure estimate. This exposure estimate was then compared to the appropriate toxicity endpoint.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 3,700 for the U.S. population, and 1,300 for children 1-6 years old, and 4,400 for females 13-50 yrs. 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 mefenoxam 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:

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 650 for females 13-50 years old, 560 for the U.S. population, and 230 for children 1-6 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of mefenoxam in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5:

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 theFederal 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_180/Title_40/40cfr180_00.html, a beta site currently under development.-

2. In person. The Agency has established an official record for this action under docket control number OPP-301172. 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 17, 1998 (63 FR 43937)(FRL-6018-2), 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 6F4640, 3F4270) for tolerance by BASF Corporation, Agricultural Products Division, P.O 13528, Research Triangle Park, NC 27709-35281. 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 180.355(a) be amended by establishing a tolerance for combined residues of the herbicide bentazon, (3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one-2,2-dioxide and its 6- and 8-hydroxy metabolites, in or on Flax, seed at 1.0 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 a tolerance for combined residues of bentazon on Flax, seed at 1.0 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 bentazon are discussed in the Federal Register of March 8, 2000 (65 FR 12122)(FRL-6492-7) as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

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 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 (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for bentazon used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.355(a)) for the combined residues of bentazon (3-isopropyl-1H-2,1,3-benzothiadiazin-4 (3H)-one-2,2-dioxide) and its 6- and 8-hydroxy metabolites in or on a variety of raw agricultural commodities. Tolerances are also established for the combined residues of the herbicide bentazon (3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one-2,2-dioxide) and its metabolite 2-amino-N-isopropyl benzamide (AIBA) in or on the following food commodities: for cattle, goats, hogs, poultry, and sheep, fat, meat-by-products, and meat, with a tolerance of 0.05 ppm, for eggs, with a tolerance of 0.05 ppm, and milk, with a tolerance of 0.02 ppm. Risk assessments were conducted by EPA to assess dietary exposures from bentazon 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: An acute analysis was performed using tolerance level residues, 100% crop treated (CT), and DEEM® default processing factors for all commodities.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the 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: an Anticipated Residue was calculated for succulent peas using average residue values (1.08 ppm) from the submitted crop field trials. Percent CT information for several commodities was used. For all other commodities 100% CT was assumed. DEEM® default processing factors were used for all commodities.

iii. Cancer. Bentazon has been classified as a Group E chemical (evidence of non-carcinogenicity for humans) based upon lack of evidence of carcinogenicity in rats and mice.

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.

For the acute analysis, tolerance level residues and 100% CT was assumed for all commodities. For the chronic analysis, PCT information was used for mint (25%), sweet corn (13%), snap beans (15%), green peas (13%), dry beans and peas (17%), alfalfa (0%), sorghum (0%), corn (1%), rice (5%), peanuts (27%), soybeans (12%), and potatoes (0%). For alfalfa, sorghum and potatoes, which have %CT estimates of zero, a value of 1% CT was used in the analysis. For all crops other than mint, sweet corn, snap beans, green peas, dry bean and peas, alfalfa, sorghum, corn, rice, peanuts, soybeans and potatoes, 100% CT was used, and tolerance level residues were used for all crops.

The Agency believes that the three conditions listed above 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 bentazon may be applied in a particular area.

2. Dietary exposure from drinking water. Degradation products of bentazon in the tolerance expression are 8-hydroxy bentazon (plants), 6-hydroxy bentazon (plants), and AIBA (animals). AIBA was the only degradation product in the tolerance expression which was found in standard laboratory environmental fate studies. Therefore, the water assessment was conducted for bentazon and AIBA.

SCI-GROW (Screening Concentration in Ground Water) modeling indicates that bentazon residue (bentazon + AIBA) concentrations in ground water used as drinking water are not likely to exceed 4.25 parts per billion (ppb). As reported in the 1994 bentazon RED, bentazon concentrations (excluding degradation products) in ground water are higher (20 to 120 ppb) when compared to SCI-GROW model predictions. The maximum concentration of bentazon (120 ppb) was observed in shallow groundwater samples near greens and tees in a United States Geological Survey (USGS) and the Florida Department of Environmental Protection (FDEP) monitoring study. Since the monitoring data indicate a higher concentration than the SCI-GROW screening model, EPA used the 20 ppb as the representative national Tier 1 ground water screening concentration for bentazon.

Tier II PRZM-EXAMS modeling indicates that cumulative bentazon residue (bentazon + AIBA) concentrations in surface water to be used as screening concentrations for bentazon are 41 ppb for the 1 in 10 year peak (acute) and 8 ppb for the 36 year annual mean (chronic).

A preliminary review of the National Water Quality Assessment Program (NAWQA) monitoring data suggest that bentazon concentrations in surface water are substantially lower than model predictions. There are no surface water monitoring data for bentazon degradation products. Bentazon has been detected in 37 agricultural streams at a concentration of 0.05 ppb for the 95th percentile and estimated maximum concentration of 5 ppb and 14 integrator sites on large streams at a concentration of 0.15 ppb for the 95th percentile and estimated maximum concentration of 2.8 μg/L. Bentazon was not detected (less than Method of Detection Limit) in urban streams (http://water.wr.usgs.gov/pnsp/gwsw1.html, 3/27/98). Bentazon is not reported in the latest summary of the NAWQA monitoring data (Larson, et al., “Pesticides in Streams of the United States-Initial Results from the National Water-Quality Assessment Program Water Resources Investigations Report” 98-4222). Bentazon degradation products were not part of the analysis in the NAWQA monitoring program.

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

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

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use 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 bentazon they are further discussed in the aggregate risk sections below.

Based on the PRZM/EXAMS and SCI-GROW models the EECs of bentazon for acute exposures are estimated to be 41 ppb for surface water and 20 ppb for ground water. The EECs for chronic exposures are estimated to be 8 ppb for surface water and 20 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).

Bentazon is currently registered for use on the following residential non-dietary sites: turf and ornamentals. The risk assessment was conducted using the following residential exposure assumptions: Although bentazon is a registered herbicide for use on turf and ornamentals, short-term non-dietary ingestion exposure for toddlers is not assessed since EPA determined that there is no acute dietary or oral endpoint applicable to infants and children.

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 bentazon 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, bentazon 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 bentazon 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. Both the rat developmental and reproductive toxicity studies indicate increased susceptibility from in utero and post natal exposure to bentazon. The available developmental toxicity data in rabbits did not provide an indication of increased susceptibility from in utero exposure to bentazon.

3. Conclusion. There is a complete toxicity data base for bentazon and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The FQPA safety factor for protection of infants and children will be retained at 10x in assessing the risk posed by bentazon. This decision is based on:

i. Evidence of increased susceptibility following in utero exposure to bentazon in the prenatal developmental toxicity study in rats in the absence of maternal toxicity.

ii. Quantitative evidence of increased susceptibility following prenatal/postnatal exposure to bentazon in the 2-generation reproduction study in rats.

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

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to bentazon will occupy 2% of the aPAD for females 13 years and older. No appropriate end-point was available to quantitate risk to the general U.S. population from a single dose administration of bentazon. In addition, there is potential for acute dietary exposure to bentazon 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 2:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to bentazon from food will utilize less than or equal to 10% of the cPAD for the U.S. population, 12% of the cPAD for non-nursing infant and 28% of the cPAD for children 1-6 years old.

Based on the use pattern, chronic residential exposure to residues of bentazon is not expected. In addition, there is potential for chronic dietary exposure to bentazon 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).

Bentazon 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 bentazon.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 250,000 for females 13-50 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 bentazon 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. 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).

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

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 8,200 for males 20+ years old, females 13-50 years old and males 13-19 years old and 1,900 for children 1-6 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of bentazon in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5:

-5. Aggregate cancer risk for U.S. population. Bentazon has been classified as a Group E chemical (evidence of non-carcinogenicity for humans) based upon lack of evidence of carcinogenicity in rats and mice. Therefore no cancer risk is expected.

-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 bentazon residues.

Adequate enforcement methods are available for the determination of residues of bentazon and its 6- and 8-hydroxy metabolites in/on plant commodities. The Pesticide Analytical Method Volume II (PAM II) lists Method II, a GLC method with flame photometric detection for the determination of bentazon and its hydroxy metabolites in/on corn, rice, and soybeans; the limit of detection (LOD) for each compound is 0.05 ppm. Method III, modified from Method II, is available for the determination of bentazon and its hydroxy metabolites in/on peanuts and seed and pod vegetables with a LOD of 0.05 ppm for each compound. These methods are adequate to enforce the tolerances associated with this petition.

There is a Codex maximum residue limit (MRL) of 0.1 ppm for bentazon and its metabolites established in/on linseed. Therefore, a compatibility issue is relevant to the proposed flax, seed tolerance. Harmonization of the U.S. tolerance will not be possible as the use pattern proposed in this petition may result in residues which exceed the Codex MRL.

Analytical analyses of bentazon and its regulated metabolites using the FDA multiresidue protocols are required as part of the conditional registration of bentazon on flax.

Therefore, the tolerance is established for combined residues of bentazon, (3-isopropyl-H-2,1,3-Benzothiadiazin-4 (3H)-one-2,2-dioxide) and its 6- and 8-hydroxy metabolites in or on flax, seed at 1.0 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 control number OPP-301172 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 16, 2001.

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 control number OPP-301172, 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 other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). 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).

Regulations implementing the conditional Cashes Ledge and GOM Rolling Closure Areas in Framework Adjustment 33 (65 FR 21658, April 24, 2000) became effective on June 1, 2000. To help ensure that GOM cod landings remain within the target TAC established for the fishing year, Framework 33 provided a mechanism specified at 50 CFR 648.81(o) to close the area identified as the Cashes Ledge Closure Area from November 1 through November 30, and the area identified as Rolling Closure Area VI from January 1 through January 31 if the Regional Administrator determines that at least 50 percent of the average between the F0.1 target total allowable catch (TAC) and the Fmax target TAC (1.67 million lb (759 mt) for the fishing years beginning May 1, 2000, and May 1, 2001) has been landed as of, or before, July 31. Last year, on September 5, 2000, NMFS announced (65 FR 53648) that the conditional closures would become effective for the 2000 fishing year.

For the 2001 fishing year, which began on May 1, 2001, the New England Fishery Management Council (Council) voted to maintain the same GOM cod target TACs as in fishing year 2000 (for Fmax and F0.1), because of uncertainty regarding 1999 and 2000 GOM cod discard levels (66 FR 15812, March 21, 2001). The intent of retaining the same GOM cod target TACs was to prevent an increase in the exploitation of GOM cod during the 2001 fishing year. The conditional closure of Cashes Ledge in November 2001, and a portion of Massachusetts Bay in January 2002, are therefore required, if preliminary landings data through July 31, 2001, indicate that more than 1.67 million lb (759 mt) of GOM cod has been landed. NMFS is required to publish notification in the Federal Register informing the public of the implementation of the conditional closures if GOM cod landings exceed those levels.

Based upon the best available scientific information, the Regional Administrator has determined that at least 1.67 million lb (759 mt) of GOM cod has been landed as of July 31, 2001. Therefore, NMFS is implementing the conditional closure of the Cashes Ledge Closure Area, as described in § 648.81(h)(1), and Rolling Closure Area VI, as described in § 648.81(g)(1)(vi), to better ensure that GOM cod landings remain within the target TACs established for the 2001 fishing year. Pursuant to § 648.81(o), the Cashes Ledge Closure Area will be closed from November 1, 2001, through November 30, 2001, and Rolling Closure Area VI will be closed from January 1, 2002, through January 31, 2002, to all fishing vessels, and to fishing gear capable of catching Northeast multispecies, except as provided under § 648.81(h)(2) and (g)(2).

The coordinates of the closed areas are as follows:

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.