acifluorfen (Tackle) Proposed Tolerance 4/96
[Federal Register: April 17, 1996 (Volume 61, Number 75)] [Notices]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF TRANSPORTATION ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0E3821/P649; FRL-5356-6]
Sodium Salt of Acifluorfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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: firstname.lastname@example.org. 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
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 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<SUP>*) of 0.107 (mg/kg/day)<SUP>-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<SUP>-7. The proposed use on strawberry accounts for 1.9 x
10<SUP>-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:
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
Dated: April 3, 1996.
Susan Lewis, Acting Director, Registration Division, Office of Pesticide
Therefore, it is proposed that 40 CFR part 180 be amended as follows:
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.
* * *
* * * * *
Strawberry..... ........ 0.05