[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]


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.


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.

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 
    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 
    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 


    1. The authority citation for part 180 continues to read as 

    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.

*      *      *

                          Commodities                              per  
                  *        *        *        *        *                 
Strawberry.....................................................    0.05 

[FR Doc. 96-9471 Filed 4-16-96; 8:45 am]