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Flutolanil (AgrEvo). August 16, 1995. Pesticide Tolerances. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1995/August/Day-16/pr-377.html
[Federal Register: August 16, 1995 (Volume 60, Number 158)] [Rules and Regulations][[Page 42456]]
40 CFR Parts 180 and 185
40 CFR Parts 180 and 185
[PP 4F4342 and FAP 4H5711/R2153; FRL-4966-8] RIN 2070-AB78
Flutolanil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This rule establishes tolerances for combined residues of 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 peanut nutmeats at 0.5 part per million (ppm), peanut hulls at 5.0 ppm, peanut hay at 15.0 ppm, meat, meat byproducts (mbyp) and milk of cattle, goats, hogs, horses, and sheep at 0.05 ppm, fat of cattle, goats, hogs, horses, and sheep at 0.10 ppm, liver of cattle, goats, hogs, horses, and sheep at 2.0 ppm, kidney of cattle, goats, hogs, horses, and sheep at 1.0 ppm, and poultry (including turkeys) meat, mbyp, fat, and eggs at 0.05 ppm; and in or on the processed food commodity peanut meal at 1.0 ppm when present therein as a result of application of the fungicide to growing crops. AgrEvo USA Co. submitted a petition pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA) for the regulation to establish a maximum permissible level for residues of the fungicide.
EFFECTIVE DATE: This regulation becomes effective August 16, 1995.
ADDRESSES: Written objections and hearing requests, identified by the document
control number, [PP 4F4342 and FAP 4H5711/R2153], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington,
DC 20460. 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. 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.
A copy of any objections and hearing requests filed with the Hearing Clerk may
also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov.
Copies of objections and hearing requests must be submitted as an ASCII file
avoiding the use of special characters and any form of encryption. Copies of
objections and hearing requests will also be accepted on disks in WordPerfect
in 5.1 file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the document number [PP 4F4342
and FAP 4H5711/R2153]. No Confidential Business Information (CBI) should be
submitted through email. Electronic copies of 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 Hwy., Arlington, VA 22202, (703)-305-6226; e-mail: welch.connie@.epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of February 8, 1995 (60 FR 7540), which announced that AgrEvo USA Co. had submitted pesticide petitions (PP) 4F4342 and 4H5711 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 tolerances for combined residues of 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 peanut nutmeats at 0.5 part per million (ppm), peanut hulls at 5.0 ppm, peanut hay at 15.0 ppm, meat, mbyp, and milk of cattle, goats, hogs, horses, and sheep at 0.05 ppm, fat of cattle, goats, hogs, horses, and sheep at 0.10 ppm, liver of cattle, goats, hogs, horses, and sheep at 2.0 ppm, kidney of cattle, goats, hogs, horses, and sheep at 1.0 ppm, and poultry meat, mbyp, fat and eggs (including turkeys) at 0.05 ppm; and in or on the processed food commodity peanut meal at 1.0 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:
7. 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.
8. 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. 9. A two-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).
10. 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 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 lower 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).
As the first food use of this chemical, tolerances for flutolanil have yet
to be published in the CFR. Tolerance level residues and 100- percent-crop-
treated assumptions were made for the proposed commodities. Anticipated
residues and percent crop treated information were not available for this
analysis.
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 Hwy., 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-perbillion 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 currently no actions pending against
the continued 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 185 will
protect the public health. 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). A record has been established
for this rulemaking under docket number, [PP 4F4342 and FAP 4H5711/R2153]
(including objections and hearing requests submitted electronically as described
below). 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 Rm. 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.
Written objections and hearing requests, identified by the document control
number, [PP 4F4342 and 4H5711/R2153], may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., Washington,
DC 20460.
A copy of electronic objections and hearing requests can be sent directly
to EPA at:
opp-docket@epamail.epa.gov.
A copy of electronic objections and hearing requests may be submitted as
an ASCII file avoiding the use of special characters and any form of encryption.
The official record for this rulemaking, the public version, as described
above will be kept in paper form. Accordingly, EPA will transfer any objections
and hearing requests received electronically into printed, paper form as
they are received and will place the paper copies in the official rulemaking
record which will also include all objections and hearing requests 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
[[Page 42458]]
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 Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: July 31, 1995.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations is amended as follows:
PART 180--[AMENDED]
b. By adding new Sec. 180.484, to read as follows:
Sec. 180.484 Flutolanil (N-(3-(1-methylethoxy)phenyl)-2- (trifluoromethyl)benzamide); tolerances for residues.
Tolerances are established for residues of 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
Commodity million
Cattle, fat................................................ 0.10 Cattle,
kidney............................................. 1.00 Cattle, liver..............................................
2.00 Cattle, mbyp............................................... 0.05
Cattle, meat............................................... 0.05 Cattle,
milk............................................... 0.05 Eggs.......................................................
0.05 Goats, fat................................................. 0.10
Goats, kidney.............................................. 1.00 Goats,
liver............................................... 2.00 Goats, mbyp................................................
0.05 Goats, meat................................................ 0.05
Goats, milk................................................ 0.05 Hogs,
fat.................................................. 0.10 Hogs, kidney...............................................
1.00 Hogs, liver................................................ 2.00
Hogs, mbyp................................................. 0.05 Hogs,
meat................................................. 0.05 Hogs, milk.................................................
0.05 Horses, fat................................................ 0.10
Horses, kidney............................................. 1.00 Horses,
liver.............................................. 2.00 Horses, mbyp...............................................
0.05 Horses, meat............................................... 0.05
Horses, milk............................................... 0.05 Peanuts....................................................
0.5 Peanut hay................................................. 15.0 Peanut
hulls............................................... 5.0 Poultry (including
turkerys), fat.......................... 0.05 Poultry (including turkeys),
mbyp.......................... 0.05 Poultry (including turkeys), meat..........................
0.05 Sheep, fat................................................. 0.10
Sheep, kidney.............................................. 1.00 Sheep,
liver............................................... 2.00 Sheep, meat................................................
0.05 Sheep, mbyp................................................ 0.05
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 348.
b. By adding new Sec. 185.3385, to read as follows:
Sec. 185.3385 Flutolanil (N-(3-(1-methylethoxy)phenyl)-2- (trifluoromethyl)benzamide).
A food additive regulation is established permitting the combined residues of the insecticide 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 processed food commodity:
Parts per
Commodity million
Peanut meal................................................ 1.0
[FR Doc. 95-20015 Filed 8-15-95; 8:45 am] BILLING CODE 6560-50-F