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Lactofen. March 8, 1996. Proposed Pesticide Tolerance. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/March/Day-08/pr-587.html
[Federal Register: March 8, 1996 (Volume 61, Number 47)] [Proposed Rules]
[Page 9399-9401]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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 email.
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<SUP>-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<SUP>* of 0.16 (mg/kg/day)<SUP>-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]
(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