flutolanil (Moncoat) Pesticide Tolerances 7/95
Date: Wed, 16 Aug 1995 10:23:24 -0400
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Flutolanil; Pesticide Tolerances X-Comment: U.S. EPA FEDERAL REGISTER
PESTICIDE documents
[Federal Register: August 16, 1995 (Volume 60, Number 158)] [Rules and
Regulations]
[Page 42456-42458]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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[[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.
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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 e-
mail. 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:
1. Several acute toxicity studies that place technical flutolanil in
Toxicity Category III (Caution). Data show minimal-to-slight irritation to
the eye.
2. 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 the 339-mg/kg/day females and
the 1,512-mg/kg/day males and the 1,743-mg/kg/day females, along with a
slight decrease in body weight in the 1,512-mg/kg/day males.
3. 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.
4. 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.
5. 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 lowest- observed-
effect level (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.
6. 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).
[[Page 42457]]
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 (1.8% of 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-
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 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
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]
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. 180.484, 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
Sheep, milk................................................ 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
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