PMEP Home Page --> Pesticide Active Ingredient Information --> Fungicides and Nematicides --> famoxadone to sulfur (Kolospray) --> flutolanil (Moncoat) --> flutolanil (Moncoat) Pesticide Tolerances 7/95

flutolanil (Moncoat) Pesticide Tolerances 7/95

Date: Wed, 16 Aug 1995 10:23:24 -0400
Reply-To: epa-pest@unixmail.rtpnc.epa.gov Originator: epa-
pest@unixmail.rtpnc.epa.gov Sender: epa-pest@unixmail.rtpnc.epa.gov
Precedence: bulk
From: S001627@swais.access.gpo.gov
To: Multiple recipients of list <epa-pest@unixmail.rtpnc.epa.gov> Subject: 
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] 


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

[[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 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