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Flumiclorac Pentyl (Valent). November 30, 1994, Pesticide Tolerances and Feed Additive Regulation. Final Rule. Federal Register.
[Federal Register: November 30, 1994] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 180 and 186 [PP 3F4234 and FAP 3H5682/R2091; FRL-4922-9] RIN 2070-AB78 Pesticide Tolerances and Feed Additive Regulation For Flumiclorac Pentyl AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: These rules establish tolerances for residues of the herbicide flumiclorac pentyl in or on the raw agricultural commodities field corn, grain; field corn, fodder; field corn, forage; and soybean, seed at 0.01 part per million (ppm), and in or on the feed additive commodity soybean hulls at 0.02 ppm. Valent U.S.A. Corp. requested these regulations to establish maximum permissible levels for residues of the herbicide. EFFECTIVE DATE: These regulations become effective November 30, 1994. ADDRESSES: Written objections and hearing requests, identified by the document control number, [PP 3F4234 and FAP 3H5682/R2091], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product Manager (PM-23), Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 237, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7830. SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of June 29, 1994 (59 FR 33503), which announced that Valent U.S.A. Corp., 1333 N. California Blvd., Suite 600, Walnut Creek, CA 95496, had submitted a pesticide petition (PP 3F4234) to EPA requesting that the Administrator, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish a tolerance for residues of the herbicide flumiclorac pentyl (pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H- isoindol-2-yl)phenoxy]acetate), including all metabolites of flumiclorac pentyl, in or on the raw agricultural commodity field corn, grain; field corn, fodder; field corn, forage; and soybean, seed at 0.01 part per million (ppm). Valent had previously submitted feed additive petition (FAP) 3H5682 to EPA (see the Federal Register of October 21, 1993 (58 FR 54356)) proposing under section 409 of the FFDCA (21 U.S.C. 348) an amendment to 40 CFR part 186 to establish a feed additive regulation for flumiclorac pentyl in or on soybean hulls at 0.02 ppm that inadvertently appeared under petition number FAP 3H5665: The correct petition number is FAP 3H5682. The tolerance level for each commodity is expressed in terms of the parent only, which serves as an indicator of the use of flumiclorac pentyl on these commodities. There were no comments received in response to the notice of filing. The scientific data submitted in the petitions and other relevant material have been evaluated. The toxicological data considered in support of the tolerances include: 1. Acute toxicological studies placing the technical-grade flumiclorac pentyl in Toxicity Category III. 2. A 90-day feeding study in rats resulted in a lowest-observed- effect level (LOEL) of 659 mg/kg/day in males and 724 mg/kg/day in females, and a no-observed-effect level (NOEL) of 64.9 mg/kg/day in males and 70.6 mg/kg/day in females. 3. A 90-day feeding study in dogs resulted in a NOEL of 100 mg/kg/ day in males and 10 mg/kg/day in females, and a LOEL of 1,000 mg/kg/day in males and 100 mg/kg/day in females. The only significant finding in males was slight to mild vacuolation in the kidneys in the 1,000-mg/kg/ day group. In females, a prolongation of the activated partial thromboplastin time was observed in the 100- and 1,000-mg/kg/day groups. 4. A 21-day dermal toxicity study in rats resulted in the LOEL for systemic and dermal toxicity of greater than 1,000 mg/kg/day. No treatment-related effects were noted in mortality, body weight gain, food consumption, clinical pathology, or absolute and relative organ weight gains. No relevant histopathological findings were observed. 5. A 1-year chronic oral toxicity study in dogs resulted in a LOEL of 1,000 mg/kg/day and a NOEL of 100 mg/kg/day for systemic toxicity. There were no treatment-related clinical signs. 6. A 79-week oncogenicity study in mice resulted in a LOEL of 307.9 mg/kg/day and a NOEL of 31.5 mg/kg/day for systemic toxicity in males and a NOEL of 850.2 mg/kg/day for females. There was no evidence of carcinogenicity in this study. 7. A combined chronic toxicity/carcinogenicity study in rats was performed. Consistent treatment-related changes at both 360.4 and 744.9 mg/kg/day were observed in males, while no treatment-related effects were noted in females. Based on these findings, a LOEL of 360 mg/kg/day and a NOEL of 35 mg/kg/day were established for systemic toxicity in male rats, and a NOEL of 919.4 mg/kg/day was established for female rats. There was no evidence of carcinogenicity in this study. 8. Teratology--developmental toxicity studies performed on rabbits and rats. No developmental toxicity was present at the highest dose tested in any of the four studies performed. 9. A dietary two-generation reproduction study in rats resulted in a systemic NOEL of 16 mg/kg/day in males and 18 mg/kg/day in females, and a reproductive NOEL of 16 mg/kg/day in males and 18 mg/kg/day in females. 10. A micronucleus study was performed to test structural chromosomal aberration on male and female ICR mice. No significant differences in the frequency of micronucleated cells were noted in the bone marrow cells of the treated animals. 11. An in vitro unscheduled DNA synthesis assay was performed on rats to examine other genotoxic effects. At concentrations up to 300 micrograms/mL, unscheduled DNA synthesis was not elicited in primary cultures of rat hepatocytes. 12. Metabolism studies in rats resulted in essentially all of the administered dose being eliminated within 2 days of dosing. Based on the results of the study, the high amounts of unmetabolized chemical present in the feces was determined to be due to lack of absorption rather than biliary excretion. The Office of Pesticide Programs' Health Effects Division's Carcinogenicity Peer Review Committee (CPRC) has classified flumiclorac pentyl in Group E carcinogen (no evidence of carcinogenicity) under the Agency's ``Guidelines for Carcinogen Risk Assessment,'' published in the Federal Register of September 24, 1986 (51 FR 33992). In its evaluation, CPRC gave consideration to organ weight changes in the 2- year feeding study in rats and the 2-year feeding study in mice. The Reference Dose (RfD) is established at 0.35 mg/kg/day, based on a NOEL of 35.4 mg/kg/day from the 2-year feeding study in rats and an uncertainty factor of 100. The Theoretical Maximum Residue Contribution (TMRC) from the current action is estimated at 0.001005 mg/kg of body weight/day for the general population and utilizes less than 1% of the RfD for the U.S. population. The TMRC for the most exposed subgroups are 0.000012 mg/kg body weight/day for nonnursing infants (less than 1 year old) and 0.000009 mg/kg body weight/day for children (1 to 6 years old), or 0.0036 and 0.0026 percent of the RfD, respectively. Therefore, no appreciable risk is expected from chronic dietary intake since the RfD is not exceeded for either the general population or any subgroup. The nature of the residue is adequately understood for the purposes of the tolerance. An adequate analytical method, gas chromatography with a thermionic-specific detector, is available for enforcement purposes. The enforcement methodology has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual, Vol. II (PAM II). Because of the long lead time for publication of the method in PAM II, the analytical methodology is being made available in the interim to anyone interested in pesticide enforcement when requested from: Calvin Furlow, Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202 (703)-305-5232. There is no reasonable expectation that secondary residues will occur in milk, eggs or meat of livestock or poultry as a result of this action. The pesticide is considered useful for the purpose for which the tolerances are sought, and the tolerances are capable of achieving the intended physical or technical effect. There are currently no actions pending against the registration of this chemical. Based on the information and data considered, the Agency has determined that the tolerances established by amending 40 CFR parts 180 and 186 will protect the public health and that use of the pesticide in accordance with the terms of the proposed food additive tolerance will be safe. Therefore, the tolerances are established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections to the regulation and may also request a hearing on those objections. Objections and hearing requests must be filed with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(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). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is 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 issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB)). Under section 3(f), the order defines ``significant'' as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also known as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of this Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Parts 180 and 186 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 18, 1994. Daniel M. Barolo, Director, Office of Pesticide Programs. Therefore, 40 CFR parts 180 and 186 are amended as follows: PART 180--[AMENDED] 1. In part 180: a. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. b. By adding new Sec. 180.477, to read as follows: Sec. 180.477 Flumiclorac pentyl; tolerances for residues. Tolerances are established for residues of the herbicide flumiclorac pentyl, pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro- 1,3-dioxo-2H-isoindol-2-yl)phenoxy]acetate, including all the metabolites of flumiclorac pentyl, in or on the raw agricultural commodities listed below. The tolerance level for each commodity is expressed in terms of the parent only which serves as an indicator of the use of flumiclorac pentyl on these raw agricultural commodities. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Corn, field, grain......................................... 0.01 Corn, field, fodder........................................ 0.01 Corn, field, forage........................................ 0.01 Soybean, seed.............................................. 0.01 ------------------------------------------------------------------------ PART 186--[AMENDED] 2. In part 186: a. The authority citation for part 186 continues to read as follows: Authority: 21 U.S.C. 348. b. By adding new Sec. 186.3325, to read as follows: Sec. 186.3325 Flumiclorac pentyl; tolerances for residues. Tolerances are established for residues of the herbicide flumiclorac pentyl, pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro- 1,3-dioxo-2H-isoindol-2-yl)phenoxy]acetate, including all the metabolites of flumiclorac pentyl, in or on the feeds listed below. The tolerance level for each commodity is expressed in terms of the parent only which serves as an indicator of the use of flumiclorac pentyl on these feeds. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Soybean, hulls............................................. 0.02 ------------------------------------------------------------------------ [FR Doc. 94-29499 Filed 11-29-94; 8:45 am] BILLING CODE 6560-50-F