[Federal Register Volume 59, Number 229 (Wednesday, November 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29499]


[[Page Unknown]]

[Federal Register: November 30, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186

[PP 3F4234 and FAP 3H5682/R2091; FRL-4922-9]
RIN 2070-AB78

 

Pesticide Tolerances and Feed Additive Regulation For Flumiclorac 
Pentyl

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: These rules establish tolerances for residues of the herbicide 
flumiclorac pentyl in or on the raw agricultural commodities field 
corn, grain; field corn, fodder; field corn, forage; and soybean, seed 
at 0.01 part per million (ppm), and in or on the feed additive 
commodity soybean hulls at 0.02 ppm. Valent U.S.A. Corp. requested 
these regulations to establish maximum permissible levels for residues 
of the herbicide.

EFFECTIVE DATE: These regulations become effective November 30, 1994.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 3F4234 and FAP 3H5682/R2091], may be 
submitted to: Hearing Clerk (1900), Environmental Protection Agency, 
Rm. M3708, 401 M St., SW., Washington, DC 20460. 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. 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.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product 
Manager (PM-23), Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 237, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7830.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of June 29, 1994 (59 FR 33503), which announced that 
Valent U.S.A. Corp., 1333 N. California Blvd., Suite 600, Walnut Creek, 
CA 95496, had submitted a pesticide petition (PP 3F4234) 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 a tolerance for residues of the herbicide flumiclorac pentyl 
(pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-
isoindol-2-yl)phenoxy]acetate), including all metabolites of 
flumiclorac pentyl, in or on the raw agricultural commodity field corn, 
grain; field corn, fodder; field corn, forage; and soybean, seed at 
0.01 part per million (ppm). Valent had previously submitted feed 
additive petition (FAP) 3H5682 to EPA (see the Federal Register of 
October 21, 1993 (58 FR 54356)) proposing under section 409 of the 
FFDCA (21 U.S.C. 348) an amendment to 40 CFR part 186 to establish a 
feed additive regulation for flumiclorac pentyl in or on soybean hulls 
at 0.02 ppm that inadvertently appeared under petition number FAP 
3H5665: The correct petition number is FAP 3H5682. The tolerance level 
for each commodity is expressed in terms of the parent only, which 
serves as an indicator of the use of flumiclorac pentyl on these 
commodities.
    There were no comments received in response to the notice of 
filing. The scientific data submitted in the petitions and other 
relevant material have been evaluated. The toxicological data 
considered in support of the tolerances include:
    1. Acute toxicological studies placing the technical-grade 
flumiclorac pentyl in Toxicity Category III.
    2. A 90-day feeding study in rats resulted in a lowest-observed-
effect level (LOEL) of 659 mg/kg/day in males and 724 mg/kg/day in 
females, and a no-observed-effect level (NOEL) of 64.9 mg/kg/day in 
males and 70.6 mg/kg/day in females.
    3. A 90-day feeding study in dogs resulted in a NOEL of 100 mg/kg/
day in males and 10 mg/kg/day in females, and a LOEL of 1,000 mg/kg/day 
in males and 100 mg/kg/day in females. The only significant finding in 
males was slight to mild vacuolation in the kidneys in the 1,000-mg/kg/
day group. In females, a prolongation of the activated partial 
thromboplastin time was observed in the 100- and 1,000-mg/kg/day 
groups.
    4. A 21-day dermal toxicity study in rats resulted in the LOEL for 
systemic and dermal toxicity of greater than 1,000 mg/kg/day. No 
treatment-related effects were noted in mortality, body weight gain, 
food consumption, clinical pathology, or absolute and relative organ 
weight gains. No relevant histopathological findings were observed.
    5. A 1-year chronic oral toxicity study in dogs resulted in a LOEL 
of 1,000 mg/kg/day and a NOEL of 100 mg/kg/day for systemic toxicity. 
There were no treatment-related clinical signs.
    6. A 79-week oncogenicity study in mice resulted in a LOEL of 307.9 
mg/kg/day and a NOEL of 31.5 mg/kg/day for systemic toxicity in males 
and a NOEL of 850.2 mg/kg/day for females. There was no evidence of 
carcinogenicity in this study.
    7. A combined chronic toxicity/carcinogenicity study in rats was 
performed. Consistent treatment-related changes at both 360.4 and 744.9 
mg/kg/day were observed in males, while no treatment-related effects 
were noted in females. Based on these findings, a LOEL of 360 mg/kg/day 
and a NOEL of 35 mg/kg/day were established for systemic toxicity in 
male rats, and a NOEL of 919.4 mg/kg/day was established for female 
rats. There was no evidence of carcinogenicity in this study.
    8. Teratology--developmental toxicity studies performed on rabbits 
and rats. No developmental toxicity was present at the highest dose 
tested in any of the four studies performed.
    9. A dietary two-generation reproduction study in rats resulted in 
a systemic NOEL of 16 mg/kg/day in males and 18 mg/kg/day in females, 
and a reproductive NOEL of 16 mg/kg/day in males and 18 mg/kg/day in 
females.
    10. A micronucleus study was performed to test structural 
chromosomal aberration on male and female ICR mice. No significant 
differences in the frequency of micronucleated cells were noted in the 
bone marrow cells of the treated animals.
    11. An in vitro unscheduled DNA synthesis assay was performed on 
rats to examine other genotoxic effects. At concentrations up to 300 
micrograms/mL, unscheduled DNA synthesis was not elicited in primary 
cultures of rat hepatocytes.
    12. Metabolism studies in rats resulted in essentially all of the 
administered dose being eliminated within 2 days of dosing. Based on 
the results of the study, the high amounts of unmetabolized chemical 
present in the feces was determined to be due to lack of absorption 
rather than biliary excretion.
    The Office of Pesticide Programs' Health Effects Division's 
Carcinogenicity Peer Review Committee (CPRC) has classified flumiclorac 
pentyl in Group E carcinogen (no evidence of carcinogenicity) under the 
Agency's ``Guidelines for Carcinogen Risk Assessment,'' published in 
the Federal Register of September 24, 1986 (51 FR 33992). In its 
evaluation, CPRC gave consideration to organ weight changes in the 2-
year feeding study in rats and the 2-year feeding study in mice.
    The Reference Dose (RfD) is established at 0.35 mg/kg/day, based on 
a NOEL of 35.4 mg/kg/day from the 2-year feeding study in rats and an 
uncertainty factor of 100. The Theoretical Maximum Residue Contribution 
(TMRC) from the current action is estimated at 0.001005 mg/kg of body 
weight/day for the general population and utilizes less than 1% of the 
RfD for the U.S. population. The TMRC for the most exposed subgroups 
are 0.000012 mg/kg body weight/day for nonnursing infants (less than 1 
year old) and 0.000009 mg/kg body weight/day for children (1 to 6 years 
old), or 0.0036 and 0.0026 percent of the RfD, respectively. Therefore, 
no appreciable risk is expected from chronic dietary intake since the 
RfD is not exceeded for either the general population or any subgroup.
    The nature of the residue is adequately understood for the purposes 
of the tolerance.
    An adequate analytical method, gas chromatography with a 
thermionic-specific detector, is available for enforcement purposes.
    The enforcement methodology has been submitted to the Food and Drug 
Administration for publication in the Pesticide Analytical Manual, Vol. 
II (PAM II). Because of the long lead time for publication of the 
method in PAM II, the analytical methodology is being made available in 
the interim to anyone interested in pesticide enforcement when 
requested 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.
    There is no reasonable expectation that secondary residues will 
occur in milk, eggs or meat of livestock or poultry as a result of this 
action.
    The pesticide is considered useful for the purpose for which the 
tolerances are sought, and the tolerances are capable of achieving the 
intended physical or technical effect. There are currently no actions 
pending against the 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 186 will protect the public health and that use of the pesticide in 
accordance with the terms of the proposed food additive tolerance will 
be safe. 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).
    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 Parts 180 and 186

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

Dated: November 18, 1994.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR parts 180 and 186 are 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. 180.477, to read as follows:


Sec. 180.477   Flumiclorac pentyl; tolerances for residues.

    Tolerances are established for residues of the herbicide 
flumiclorac pentyl, pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-
1,3-dioxo-2H-isoindol-2-yl)phenoxy]acetate, including all the 
metabolites of flumiclorac pentyl, in or on the raw agricultural 
commodities listed below. The tolerance level for each commodity is 
expressed in terms of the parent only which serves as an indicator of 
the use of flumiclorac pentyl on these raw agricultural commodities.

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
Corn, field, grain.........................................         0.01
Corn, field, fodder........................................         0.01
Corn, field, forage........................................         0.01
Soybean, seed..............................................         0.01
                                                                        
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PART 186--[AMENDED]

    2. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348.

    b. By adding new Sec. 186.3325, to read as follows:


Sec. 186.3325   Flumiclorac pentyl; tolerances for residues.

    Tolerances are established for residues of the herbicide 
flumiclorac pentyl, pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-
1,3-dioxo-2H-isoindol-2-yl)phenoxy]acetate, including all the 
metabolites of flumiclorac pentyl, in or on the feeds listed below. The 
tolerance level for each commodity is expressed in terms of the parent 
only which serves as an indicator of the use of flumiclorac pentyl on 
these feeds.

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
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Soybean, hulls.............................................         0.02
                                                                        
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[FR Doc. 94-29499 Filed 11-29-94; 8:45 am]
BILLING CODE 6560-50-F