Flutolanil; Pesticide Tolerances
[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]
[DOCID:fr16au95-19]
-----------------------------------------------------------------------
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 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
[[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]
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
![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}