[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.
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Parts per
Commodity million
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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.
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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
