[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Proposed Rules]
[Pages 31075-31077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15480]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6E4653/P665; FRL-5377-4]
RIN 2070-AC18
Sodium Salt of Fomesafen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a time-limited tolerance for
residues of the herbicide sodium salt of fomesafen (also referred to in
this document as fomesafen) in or on the raw agricultural commodity
snap beans. The proposed regulation to establish a maximum permissible
level for residues of the herbicide was requested in a petition
submitted by the Interregional Research Project No. 4 (IR-4).
DATES: Comments, identified by the docket number [PP 6E4653/P665], must
be received on or before July 19, 1996.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202.
Comments and data may also be submitted to OPP by sending
electronic mail (e-mail) to:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number [PP 6E4653/P665]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries. Additional
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information on electronic submissions can be found in the
``SUPPLEMENTARY INFORMATION'' section of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8 a .m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460.
Office location and telephone number: Sixth Floor, Crystal Station #1,
2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8783; e-
mail: jamerson.hoyt@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP) 6E4653 to EPA on behalf of the Agricultural Experiment
Stations of Arkansas, Georgia, Kentucky, Minnesota, New York, North
Carolina, Tennessee, and Virginia.
This petition requests that the Administrator, pursuant to section
408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(e), amend 40 CFR 180.433 by establishing a time-limited tolerance
for residues of the sodium salt of fomesafen, 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide, in or on
the raw agricultural commodity snap beans at 0.05 parts per million
(ppm). IR-4 proposed that registration for use of fomesafen on snap
beans be geographically limited to the following states: Alabama,
Arkansas, Delaware, Georgia, Indiana, Illinois, Iowa, Kansas, Kentucky,
Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota,
Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, New York,
North Carolina, Oklahoma, Ohio, Pennsylvania, Rhode Island, South
Carolina, Tennessee, Texas, Vermont, Virginia, West Virginia, and
Wisconsin. Additional geographical restrictions, within these states,
will be specified on the pesticide label.
EPA is proposing to establish this tolerance with an expiration
date of December 31, 1998, to allow IR-4 time to conduct additional
residue field trials in support of a permanent tolerance for regional
registration for use of fomesafen on snap beans. The available residue
data show no-detectable residues (less than 0.05 ppm) on snap beans
from the proposed use pattern. The requested residue field trials are
expected to provide confirmatory data in support of a permanent
tolerance for residues of fomesafen on snap beans at 0.05 ppm.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerance include:
(1) A 6-month feeding study in dogs fed diets containing 0, 0.1,
1.0 or 25 mg/kg/day with a no-observed-effect level (NOEL) of 1.0 mg/
kg/day. Dogs fed 25 mg/kg/day demonstrated altered lipid metabolism and
liver change.
(2) A 2-year feeding/carcinogenicity study with rats fed diets
containing 0, 5, 100, or 1,000 ppm with a NOEL for systemic effects of
5 ppm (0.25 mg/kg/day). At the lowest-effect level (LEL) 100 ppm (5 mg/
kg/day) there was liver toxicity and decreased body weight. There were
no carcinogenic effects observed under the conditions of the study.
(3) A 2-year feeding/carcinogenicity study with mice fed diets
containing 0, 1, 10, 100, or 1,000 ppm (equivalent to 0.15, 1.5, 15, or
150 mg/kg/day) with statistically significant increases in the
incidences of liver adenomas in male mice at 1, 100, and 1,000 ppm and
in female mice at 100 and 1,000 ppm, and statistically significant
increases in the incidences of liver carcinomas and combined liver
carcinomas and adenomas in both sexes at 1,000 ppm.
(4) A 2-generation reproduction study in rats fed diets containing
0, 50, 250, or 1,000 ppm (equivalent to 2.5, 12.5, or 50 mg/kg/day)
with no reproductive effects observed. The NOEL for systemic toxicity
(reduction in body weight and liver necrosis) is established at 250 ppm
for this study.
(5) A developmental toxicity study in rats given oral doses of 0,
50, 100, or 200 mg/kg/day on gestation days 6 to 15 with no
developmental toxicity.
(6) A developmental toxicity study in rabbits given oral doses of
0, 2.5, 10, or 40 mg/kg/day on gestation days 6 to 18 with no
developmental toxicity.
(7) Fomesafen tested negative in assay systems for gene mutation,
structural chromosome aberration, and other genotoxic effects.
Fomesafen did produce a weak clastogenic response in rat bone marrow.
(8) Metabolism studies in rats indicate that more than 90 percent
of the compound is excreted within 7 days of ingestion. The rat
metabolism studies also show that fomesafen tends to concentrate in the
liver, prior to excretion. Fomesafen is metabolized through hydrolytic
cleavage of the amide linkage to form aciflurofen, which is classified
by EPA as a probable human carcinogen (Group B2).
Based on a weight-of evidence determination, OPP's Health Effects
Division, Carcinogenicity Peer Review Committee (CPRC) has classified
fomesafen as a Group C carcinogen (possible human carcinogen). The
upper-bound carcinogenic risk from dietary exposure to fomesafen was
calculated using a potency factor (Q*) of 0.19 (mg/kg/day)-1
and dietary exposure as estimated by the Anticipated Residue
Contribution (ARC) for existing tolerances and the proposed tolerance
for snap beans. The upper-bound carcinogenic risk from established
tolerances and the proposed tolerance for snap beans is calculated at
1.56 x 10-6. The upper-bound cancinogenic risk from the proposed
use on snap beans is calculated at 1.4 x 10-6. EPA concludes
that the potential cancer risk from residues of fomesafen resulting
from established tolerances and the proposed tolerance for snap beans
is negligible.
The Reference Dose (RfD) for fomesafen has not been established by
OPP's Health Effects Division, RfD Committee. For purposes of this
action, the RfD is calculated at 0.0025 mg/kg of body weight/day. The
RfD is based on a NOEL of 0.25 mg/kg/day from the rat feeding/
carcinogenicity study and an uncertainty factor of 100. The ARC for the
overall U.S. population from established tolerances and the proposed
tolerance for snap beans utilizes less than 1 percent of the RfD. EPA
generally has no concern for exposures below 100 percent of the RfD.
The nature of the residue in plants and animals is adequately
understood. The residue of concern is fomesafen per se. An adequate
analytical method for enforcing this tolerance has been published in
the Pesticide Analytical Manual (PAM 11). Secondary residues are not
expected to occur in milk, eggs, and meat as a result of this action
since snap beans are not a significant livestock feed commodity.
There are presently no actions pending against the continued
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registration of this chemical. The pesticide is considered useful for
the purpose for which the tolerance is sought.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
would protect the public health. Therefore, it is proposed that the
tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number [PP 6E4653/P665].
A record has been established for this rulemaking under docket
number [PP 6E4653/P665], (including comments and data 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 Room 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.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments 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 comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the Virginia 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.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (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 explaining the factual basis for this
determination 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: June 7, 1996.
Susan Lewis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.433, by designating the existing text as paragraph
(a) and by adding a paragraph (b) to read as follows:
Sec. 180.433 Sodium salt of fomesafen; tolerances for residues.
(a) * * *
(b) Tolerances with regional registration are established for
residues of the sodium salt of fomesafen, 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-4-N-(methylsulfonyl)-2-nitrobenzamide, in or
on the raw agricultural commodities, as follows:
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Parts per
Commodities million Expiration date
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Beans, snap........................ 0.05 December 31, 1998
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[FR Doc. 96-15480 Filed 6-18-96; 8:45 am]
BILLING CODE 6560-50-F
