[Federal Register Volume 61, Number 75 (Wednesday, April 17, 1996)]
[Proposed Rules]
[Pages 16740-16742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9471]
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DEPARTMENT OF TRANSPORTATION
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0E3821/P649; FRL-5356-6]
RIN 2070-AB18
Sodium Salt of Acifluorfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
[[Page 16741]]
ACTION: Proposed Rule.
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SUMMARY: EPA proposes to establish a tolerance for combined residues of
the herbicide sodium salt of acifluorfen (also referred to in this
document as acifluorfen) in or on the raw agricultural commodity
strawberry. 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 document control number [PP 0E3821/
P649], must be received on or before May 17, 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: [email protected]. 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 0E3821/P649]. Electronic comments on this proposed
rule may be filed online at many Federal Depository Libraries.
Additional 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
Virginia 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.
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) 0E3821 to EPA on behalf of the Agricultural Experiment
Stations of Alabama, Arkansas, California, Connecticut, Florida,
Indiana, Maryland, Michigan, New York, North Carolina, Oklahoma,
Oregon, Tennessee, Virginia, and Washington. This petition requested
that the Administrator, pursuant to section 408(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 346a(e)) propose the establishment of
a tolerance for combined residues of the sodium salt of acifluorfen
(sodium 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoic acid)
and its metabolites (the corresponding acid, methyl ester and amino
analogues) in or on the raw agricultural commodity strawberry at 0.05
part per million (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 2-year feeding study in dogs fed diets containing 0, 50, 300,
or 1,800 ppm with a no-observed-effect-level (NOEL) of 50 ppm
(equivalent to 1.25 mg/kg/day). Blood coagulation was observed in test
animals at the 300 ppm dose level.
2. A 2-generation reproduction study in rats fed diets containing
0, 25, 500 or 2,500 ppm with no adverse effect on adult reproductive
performance observed under the conditions of the study. The NOEL was
established at 25 ppm (equivalent to 1.25 mg/kg of body weight/day)
based on decreased viability and increased incidence of kidney lesions
in high dose offspring.
3. A developmental toxicity study in rabbits given oral gavage
doses of 0, 3, 12, or 36 mg/kg/day with no developmental toxicity
observed at any of the dose levels tested.
4. A developmental toxicity study in rats given oral gavage doses
of 0, 20, 90, or 180 mg/kg/day with a NOEL for developmental toxicity
(reduced mean fetal weight) of 20 mg/kg/day. The NOEL for maternal
toxicity was established at 90 mg/kg/day based on reduced body weight
at the highest dose tested.
5. A 2-year carcinogenicity study in rats fed diets containing 0,
25, 150, 500, 2,500, or 5,000 ppm with a NOEL of 500 ppm (equivalent to
25 mg/kg/day). The lowest-observed-effect level was established at
2,500 ppm (equivalent to 125 mg/kg/day) based on increased liver enzyme
changes in male and female rats and renal changes (nephritis) in male
rats.
6. Acifluorfen produced positive results for gene mutation in a
mitotic recombination assay in yeast cells and a dominant lethal assay
in fruit fly. The chemical was negative in a structural chromosome
aberration test in bone marrow cells and an unscheduled DNA synthesis
test in rat hepatocytes.
7. A metabolism study in mice shows that acifluorfen is excreted
primarily as the parent compound within 4 days of ingestion.
8. An 18-month carcinogenicity study in B6C3F1 mice fed diets
containing 0, 625, 1,250, or 2,500 ppm with statistically significant
positive trends for liver tumors (adenomas, carcinomas, and adenomas/
carcinomas combined) and stomach tumors (papillomas) in both male and
in female mice. These tumor types were significantly increased at the
highest dose level tested (2,500 ppm) in male and female mice, and
liver tumors were also significantly increased at the lowest dose level
tested (625 ppm) in male mice.
9. A 2-year carcinogenicity study in CD-1 mice fed diets containing
0, 7.5, 45, or 270 ppm with a statistically significant increase in the
total number of liver tumors (primarily adenomas) in high dose (270
ppm) female mice. No significant increase in liver tumors were observed
in male mice at any feeding level tested. The highest dose tested (270
ppm) did not approximate a maximum tolerated dose in male and female
mice.
Based on a weight-of-evidence determination, OPP's Health Effects
Division, Carcinogenicity Peer Review Committee (CPRC) has classified
acifluorfen as Group B2 carcinogen (probable human carcinogen). This
decision, which is in accordance with proposed Agency guidelines
published in the Federal Register of November 23, 1984 (49 FR 46294),
was based primarily on evidence of an increased number of malignant, or
combined benign and malignant, liver tumors in multiple experiments
involving two different strains of mice. Acifluorfen also produced
uncommon stomach tumors in male and female B6C3F1 mice. Other
structurally related diethyl-ether pesticides have been shown to
[[Page 16742]]
produce liver tumors in mice. In addition, mutagenicity studies show
evidence of mutagenic activity, but not in mammalian cell systems.
The upper-bound carcinogenic risk from dietary exposure to
acifluorfen was calculated using a potency factor (Q*) of 0.107
(mg/kg/day)-1 and dietary exposure as estimated by the Anticipated
Residue Contribution (ARC) for existing tolerances and the proposed
tolerance for strawberry. The upper-bound carcinogenic risk from
established and proposed uses is calculated at 5.6 x 10-7. The
proposed use on strawberry accounts for 1.9 x 10-8 of the total
cancer risk, which is a negligible increase in risk.
The RfD for acifluorfen is established at 0.013 mg/kg of body
weight/day, based on a NOEL of 1.25 mg/kg body weight/day and an
uncertainty factor of 100. The NOEL is taken from the 2-generation rat
reproduction study in which decreased survival and increased incidence
of kidney lesions were observed in the offspring of rats fed higher
dose levels. The ARC for the overall U.S. population from established
tolerances and the proposed use on strawberry utilizes less than 1
percent of the RfD. In addition, less than 1 percent of the RfD is
utilized for all population subgroups for which EPA has dietary
consumption data. EPA generally has no cause for concern for exposures
below 100 percent of the RfD.
The nature of the residue is adequately understood for the purpose
of the proposed tolerance and an adequate analytical method, gas
chromatography, is available for enforcement purposes. An analytical
method for enforcing this tolerance has been published in the Pesticide
Analytical Manual (PAM), Vol. II. No secondary residues in meat, milk,
poultry, or eggs are expected since strawberry are not considered a
livestock feed commodity. There are presently no actions pending
against the continued registration of this chemical.
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.
A record has been established for this rulemaking under docket
number [PP 0E3821/P649] (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-D[email protected]
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, Oct. 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: April 3, 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. 180.383, the table is amended by adding alphabetically
the commodity strawberry, to read as follows:
Sec. 180.383 Sodium salt of acifluorfen; tolerances for residues.
* * *
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Parts
Commodities per
million
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* * * * *
Strawberry..................................................... 0.05
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[FR Doc. 96-9471 Filed 4-16-96; 8:45 am]
BILLING CODE 6560-50-F