[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9399-9401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5538]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4418/P643; FRL-5353-2]
RIN 2070-AB18
Lactofen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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SUMMARY: EPA proposes to establish a tolerance for the combined
residues of the herbicide lactofen in or on the raw agricultural
commodity snap beans at 0.05 part per million (ppm). 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 4E4418/
P643], must be received on or before April 8, 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. 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 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.
Comments and data may also be submitted electronically 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 4E4418/P643]. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found in SUPPLEMENTARY INFORMATION of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington,
[[Page 9400]]
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) 4E4418 to EPA on behalf of the Agricultural Experiment
Stations of Arkansas, Florida, Georgia, Oregon, 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 180.432 by establishing a tolerance for
the combined residues of lactofen, 1-(carboethoxy)ethyl-5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its associated
metabolites containing the diphenyl ether linkage expressed as lactofen
in or on the raw agricultural commodity 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 1-year feeding study with dogs fed diets containing 0, 40,
200, or 1,000/3,000 ppm with a no-observed-effect level (NOEL) of 200
ppm (equivalent to 5 milligrams (mg)/kilogram (kg)/day). Systemic
effects observed at the high dose level include decreased body weight,
renal dysfunction, a significant decrease in erythrocytes, hemoglobin,
and hematocrit, and a significant increase in blood platelets.
(2) A 2-year feeding/carcinogenicity study in rats fed diets
containing 0, 500, 1,000, or 2,000 ppm with a NOEL for systemic effects
of 500 ppm (equivalent to 25 mg/kg/day). Increased pigmentation of the
liver and kidney were observed in male and female rats at the 1,000 and
2,000 dose levels. There was an increased incidence of cellular
alterations and neoplastic nodules (benign) in the liver of rats
administered 2,000 ppm (100 mg/kg/day).
(3) An 18-month carcinogenicity study in mice fed diets containing
10, 50, or 250 ppm with statistically significant increases in liver
adenomas and carcinomas, and in the combined incidence of liver tumors
(adenomas and carcinomas) in high dose males. Statistically significant
increases in the incidences of liver adenomas and in combined liver
tumors (adenomas and carcinomas) were observed in high dose females.
Systemic effects include an increase in liver/body weight ratios and
enlarged liver cells in all treated males and the mid- and high-dose
females.
(4) A developmental toxicity study in rats given 0, 15, 50, or 150
mg/kg by oral gavage with no developmental toxicity observed under the
conditions of the study. Evidence of fetotoxicity (bent ribs) was
observed at the 150 mg/kg dose level.
(5) A developmental toxicity study in rabbits given 0, 1, 4, or 20
mg/kg/day by oral gavage with no evidence of developmental toxicity.
(6) A 2-generation reproduction study in rats fed diets containing
0, 50, 500, or 2,000 ppm with a NOEL at 50 ppm (equivalent to 2.5 mg/
kg/day) for reproductive and systemic effects. Reproductive effects
observed at the lowest-observed-effect level (500 ppm) include reduced
mean pup weight and increased pup heart and liver weights.
(7) Lactofen did not cause an increase in chromosomal aberrations
when tested with Chinese hamster ovary cells, was negative in a
mammalian cell forward mutation assay, and did not induce unscheduled
DNA synthesis in isolated rat hepatocytes. Lactofen did have a low
covalent binding index to mouse liver DNA in vivo and was positive in
the Ames Salmonella/microsome plate test using strain 1538.
Lactofen has been classified by the Office of Pesticide Program's,
Health Effects Division, Carcinogenicity Peer Review Committee (CPRC)
as a Group B2 carcinogen (probable human carcinogen). Lactofen met the
criteria of a B2 carcinogen in that it induced an increased incidence
of malignant tumors or combined malignant and benign tumors in mice and
rats. Although an increase in malignant tumors was not seen in rats,
the Committee felt that a B2 classification was appropriate since a
tumor response was seen in two species at the same site. In addition,
lactofen is structurally similar to acifluorfen, nitrofen, oxyfluorfen
and fomesafen, which have all been shown to produce liver tumors in
rodents.
Dietary risk assessments for lactofen indicate that there is
minimal risk from established tolerances and the proposed tolerance for
snap beans. Dietary risk assessments were conducted using the Reference
Dose (RfD) and the cancer potency factor for lactofen to assess chronic
risk from lactofen residues in the human diet.
The RfD for lactofen is 0.002 mg/kg of body weight/day. The RfD is
based on the lowest-observed effect level (1.5 mg/kg/day) from the 18-
month mouse feeding study and an uncertainty factor of 1,000. An
uncertainty factor of 1,000 was used to calculate the RfD since a NOEL
could not be established from the mouse study. Available information on
anticipated residues and/or percent of crop treated was used in the
analysis to estimate the Anticipated Residue Contribution (ARC) of
existing uses of lactofen and the proposed use on snap beans. The ARC
from existing uses and the proposed use utilizes less than 1 percent of
the RfD for the U.S. population and all population subgroups.
The upper-bound carcinogenic risk from dietary exposure to lactofen
is calculated at 4.3 x 10-7. The carcinogenic risk for lactofen
was calculated using the ARC estimates for dietary exposure from
existing uses and the proposed use on snap beans and a Q* of 0.16
(mg/kg/day)-1.
The nature of lactofen residues in snap beans is adequately defined
for purposes of this tolerance. The residues of concern in snap beans
are lactofen and its metabolites containing the diphenyl ether linkage.
An adequate analytical method is available for enforcement purposes.
The method is available in the Pesticide Analytical Manual, Volume II
(PAM II).
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 4E4418/P643] (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,
[[Page 9401]]
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 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: February 28, 1996.
Stephen L. Johnson,
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. 180.432, Lactofen; tolerances for residues, by revising
paragraph (a) to read as follows:
Sec. 180.432 Lactofen; tolerances for residues.
(a) Tolerances are established for the combined residues of
lactofen, 1- (carboethoxy)ethyl-5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its associated
metabolites containing the diphenyl ether linkage expressed as lactofen
in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts
Commodities per
million
------------------------------------------------------------------------
Beans, snap.................................................... 0.05
Soybeans....................................................... 0.05
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[FR Doc. 96-5538 Filed 3-7-96; 8:45 am]
BILLING CODE 6560-50-F
