[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Rules and Regulations]
[Pages 42455-42458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20015]



-----------------------------------------------------------------------

[[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: [email protected]. 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: 
[email protected].

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:
    [email protected].
    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