Flutolanil (AgrEvo). June 26, 1996. Pesticide Tolerance. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Flutolanil (AgrEvo). June 26, 1996. Pesticide Tolerance. Final Rule. Federal Register.

http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/June/Day-26/pr-775DIR/pr-775.html

[Federal Register: June 26, 1996 (Volume 61, Number 124)] [Rules and Regulations]
[Page 33041-33044]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185

[PP 4F4380 and FAP 4H5703/R2240; FRL-5369-7] RIN 2070-AB78

Flutolanil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a time-limited tolerance, to expire on April 30, 1998 for combined residues of the fungicide flutolanil N-(3- (1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil in or on the raw agricultural commodities rice grain at 2.0 ppm and rice straw at 8.0 ppm; and in or on the processed food commodities rice hull at 7.0 ppm and rice bran at 3.0 ppm, when present therein as a result of application of the fungicide to growing crops. The regulation to establish a maximum permissible level for residues of the fungicide was requested in a petition submitted by the AgrEvo USA Company.

EFFECTIVE DATE: This regulation became effective April 30, 1996.

ADDRESSES: Written objections and hearing requests, identified by the document control number, [PP 4F4380, FAP 4H5703/R2240], may be submitted

[[Page 33042]]

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.
An electronic copy of objections and hearing requests filed with the Hearing Clerk may be submitted to OPP by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov Copies of electronic objections and hearing requests must be submitted as an ASCII file avoiding 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 5.1 file format or ASCII file format. All copies of electronic objections and hearing requests must be identified by the docket number [PP 4F4380, FAP 4H5703/R2240] . No Confidential Business Information (CBI) should be submitted through e-mail. Copies of electronic objections and hearing requests on this rule may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Connie B. Welch, Product Manager (PM) 21, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 227, CM#2, 1921 Jefferson Davis Highway, Arlington, VA 22202 (703) 305-6226; e-mail: welch.connie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice (FRL-4926-4), published in theFederal Register of February 8, 1995 (60 FR 7539), which announced that AgrEvo USA Company had submitted pesticide petitions (PP) 4F4380 and FAP 4H5703 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 combined residues of the fungicide flutolanil N-(3-(1-methylethoxy)phenyl)-2- (trifluoromethyl)benzamide and its metabolites converted to 2- (trifluoromethyl) benzoic acid and calculated as flutolanil, in or on the raw agricultural commodities rice grain at 2.0 ppm and rice straw at 8.0 ppm; and in or on the processed food commodities rice hull at 7.0 ppm and rice bran at 3.0 ppm, when present therein as a result of application of the fungicide to growing crops. There were no comments received in response to the notice of filing. The scientific data submitted in the petition and other relevant material have been evaluated. The toxicological data considered in support of the tolerance include:

Several acute toxicity studies that place technical flutolanil in Toxicity Category III (Caution). Data show minimal to slight irritation to the eye.
A 90-day rat feeding study with a systemic no-observed effect level (NOEL) of 37 mg/kg/day for males and 44 mg/kg/day for females and a systemic lowest effect level (LEL) of 299 mg/kg/day for males and 339 mg/kg/day for females based on increased absolute and relative liver weights in both the 299 mg/kg/day males and 339 mg/kg/day females and the 1,512 mg/kg/day males and 1,743 mg/kg/day females, along with a slight decrease in body weight in 1,512 mg/kg/day males.
A 90-day oral study in dogs with a systemic NOEL of 80 mg/kg/ day and a systemic LEL of 400 mg/kg/day based on enlarged livers and increased glycogen deposition in the livers of both males and females. High dose (2,000 mg/kg/day) males and females showed increased alkaline phosphatase levels and cholesterol thyroid/parathyroid organ weights.
A 2-year feeding/carcinogenicity study in rats with a systemic NOEL of 86.9 mg/kg/day for males and 103.1 mg/kg/day for females and a systemic LEL of 460.5 mg/kg/day for males and 535.8 mg/kg/day for females based on reduced body weight and body weight gain in males along with decreased and absolute relative weights in females. Flutolanil was not carcinogenic under the conditions of this study.
A carcinogenicity study in mice with a systemic NOEL of 735 mg/ kg/day for males and 1,168 mg/kg/day for females and a systemic LEL of 13,333 mg/kg/day for males and 1,839 mg/kg/day for females based on body weight gains in the high dose females which were significantly lower than those of controls during the first 24 weeks of treatment. There were no effects of biological importance on survival, clinical signs, food intake, hematology, gross pathology, or histopathology. Flutolanil was not carcinogenic under the conditions of this study.
A 2-year oral feeding study in dogs with a systemic NOEL of 50 mg/kg/day for males and females and a systemic LEL of 250 mg/kg/day based on increased incidence of clinical signs (emesis, salivation, soft stools, lower body weight gains and decreased food consumption in the 250 and 1,250 mg/kg group males and females.
A rat developmental toxicity study with a maternal NOEL of 1,000 mg/kg/day (limit dose) and a developmental toxicity NOEL of 1,000 mg/kg/day (limit dose). Developmental toxicity was not observed at any dose level.
A rabbit developmental toxicity study with a maternal NOEL of 40 mg/kg/day and a maternal LEL of 200 mg/kg/day based on increased resorptions in the 200 and 1,000 mg/kg group. A developmental NOEL of 40 mg/kg/day, and a developmental LEL of 200 mg/kg/day were based on increased resorptions in the 200 and 1,000 mg/kg/day group.
A 2-generation rat reproduction study with a parental toxicity NOEL of 1,936 mg/kg/day (limit dose) and a reproductive toxicity NOEL of 1,936 mg/kg/day (limit dose).
Mutagenicity studies included: An Ames Assay which was negative; Chromosome Aberration studies which showed flutolanil induced chromosomal aberrations in cultured Chinese Hamster lung cells in the presence of metabolic activation; Reverse Data which showed that flutolanil did not cause an increase in revertant colonies using Salmonella and E.coli strains; Micronucleus Assay data which indicated that flutolanil, up to a dose of 10 gm/kg, did not induce micronuclei in the bone marrow erythrocytes of male and female mice; Unscheduled DNA Synthesis (UDS) data which showed that flutolanil did not induce UDS because the test compound failed to induce a genotoxic response in the in vitro assay; and Lymphoma mutation test data which showed that flutolanil was found to be nonmutagenic in the Mammalian Cell Gene Mutation Assay.
The Reference Dose (RfD) used in the analysis is 0.2 mg/kg bwt/ day, based on an LEL of 63.7 mg/kg bwt/day from a three generation rat reproductive study with an uncertainty factor of 300 that demonstrated decreased body weight gains and increased liver weights at the high dose of 661.8 mg/kg. Flutolanil is classified as a group E carcinogen, showing no evidence of cancer in rats or mice. The Theoretical Maximum Residue Contribution (TMRC) from the current [[Page 33043]]
action is estimated at 0.000810 mg/kg bwt/day and utilizes less than 1 percent of the RfD for the general population of the 48 States. The TMRCs for the most highly exposed subgroups, children (1 to 6 years old) is 0.003577 mg/kg bwt/day (1.812f the RfD). The residue analytical method will not be forwarded to FDA for publication at this time. This method is available for limited distribution 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 Highway, Arlington, VA 22202 (703) 305-5232. It has the following disclaimer: The method is for use only by experienced chemists who have demonstrated knowledge of the principles of trace organic analysis; and have proven skills and abilities to run a complex residue analytical method obtaining accurate results at the part per billion level. Users of this method are expected to perform additional method validation prior to using the method for either monitoring or enforcement. The method can detect gross misuse. There are presently no actions pending against the continued registration of this chemical. The pesticide is considered useful for the purpose for which the tolerance is sought. Based on the information and data considered, the Agency has determined that the tolerance established by amending 40 CFR part 180 will protect the public health. Therefore, the tolerance is 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). A record has been established for this rulemaking under the docket number [PP 4F4380 FAP 5H5703/R2240] (including any comments and data submitted electronically). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. Electronic comments can be sent directly to EPA at: opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer any copies of objections and hearing requests received electronically into printed, paper form as they are received and will place the paper copies in the official rule-making record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document. 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. 9-354, 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 explaining the factual basis for this determination was published in the Federal Register of May 4, 1981 (46 FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act (APA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 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 General Accounting Office prior to publication of the rule in today's Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2) of the APA as amended. This action does not impose any enforceable duty, or contain any ``unfunded mandates'' as described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), entitled Enhancing the Intergovernmental Partnership, or special consideration as required by Executive Order 12898 (59 FR 7629, February 16, 1994).
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides
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and pests, Reporting and recordkeeping requirements.
40 CFR Part 185
Food additive, Pesticide and pest.
Dated: April 30, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371.
  2. In Sec. 180.484 by designating the existing text as paragraph (a) and by adding a new paragraph (b) to read a follows:
  Sec. 180.484 Flutolanil N-(3-(1-methylethoxy)phenyl)-2- (trifluoromethyl)benzamide and its metabolites converted to 2- (trifluoromethyl) benzoic acid and calculated as flutolanil; tolerances for residues.
  - * * * *
    (b) Time-limited tolerances are established for the combined residues of the fungicide flutolanil N-(3-(1-methylethoxy)phenyl)-2- (trifluoromethyl)benzamide and its metabolites converted to 2- (trifluoromethyl) benzoic acid and calculated as flutolanil in or on the following raw agricultural commodities:
```
                                     Parts per                          
```
  Commodities million Expiration date
  Rice, grain...................... 2.0 April 30, 1998
  Rice, straw....................... 8.0 April 30, 1998
  
  PART 185--[AMENDED]
  2. In part 185
  a. The authority citation for part 185 continues to read as follows:
  Authority: 21 U.S.C. 346a and 371.
  b. In Sec. 185.3385 by designating the existing text as paragraph (a) and by adding a new paragraph (b) to read as follows:
  Sec. 185.3385 Flutolanil N-(3-(1-methylethoxy)phenyl)-2- (trifluoromethyl)benzamide and its metabolites converted to 2- (trifluoromethyl) benzoic acid and calculated as flutolanil; tolerances for residues.
  - * * * *
    (b) A time-limited food additive regulation is established permitting the combined residues of the fungicide flutolanil N-(3-(1- methylethoxy)phenyl)-2-(trifluoromethyl)benzamide and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil in or on the following raw processed food commodity:
```
                                     Parts per                          
```
  Commodities million Expiration date
  Rice, hull........................ 7.0 April 30, 1998 Rice, bran........................ 3.0 April 30, 1998
```
                                                                        
```
  [FR Doc. 96-16338 Filed 6-25-96; 8:45 am] BILLING CODE 6560-50-F

Rice, straw....................... 8.0 April 30, 1998