Metsulfuron Methyl (Escort) - Proposed Tolerance 12/93
Pesticide Tolerance for Metsulfuron Methyl
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document proposes that a tolerance be established
for the combined residues of the herbicide metsulfuron methyl
and its metabolite in or on the raw agricultural commodity sugarcane.
The proposed regulation to establish a maximum permissible level
for residues of the herbicide in or on the commodity was requested
in a petition submitted by the Interregional Research Project
No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP
2E4094/P572], must be received on or before January 7, 1994.
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 Hwy., Arlington, VA
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).
Information so marked 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 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Emergency Response and Minor Use Section (7505W), Registration
Division, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Sixth Floor,
Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA
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 2E4094 to EPA on behalf of the Agricultural
Experiment Station of Hawaii. 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 residues of metsulfuron methyl (methyl 2-
sulfonyl] benzoate) and its metabolite methyl 2-[[[[(4-methoxy-
hydroxybenzoate in or on the raw agricultural commodity sugarcane
at 0.05 part per million (ppm).
The 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 in dogs fed diets containing 0,
50, 500, or 5,000 ppm with a no-observed-effect level (NOEL)
of 50 ppm (equivalent to 1.25 milligrams (mg)/kilogram (kg)/day)
based on decreased serum LDH at the 500-ppm dose level.
2. A 2-year feeding/carcinogenicity study in rats fed diets
containing 0, 5, 25, 500, or 5,000 ppm with a NOEL for systemic
effects of 500 ppm (equivalent to 25 mg/kg/day) based on decreased
body weight at the 5,000-ppm dose level. No carcinogenic effects
were observed under the conditions of the study.
3. An 18-month carcinogenicity study in mice fed diets containing
0, 5, 25, 500, or 5,000 ppm (equivalent to 0, 0.75, 3.75, 75,
or 750 mk/kg/day) with no carcinogenic effects observed under
the conditions of the study.
4. A two-generation reproduction study in rats fed diets
containing 0, 25, 500 or 5,000 ppm (equivalent to 0, 1.25, 25,
or 250 mg/kg/day) with no reproductive or fetotoxic effects
observed under the conditions of the study. A maternal NOEL
for systemic effects is established at 500 ppm based on decreased
weight gain at the highest dose tested.
5. A developmental toxicity study in rats given gavage doses
of 0, 40, 250, and 1,000 mg/kg/day with no developmental or
fetal toxicity observed under the conditions of the study.
6. A developmental toxicity study in rabbits given gavage
doses of 0, 25, 100, 300, or 700 mg/kg/day with no developmental
or fetal toxicity observed under the conditions of the study.
A maternal NOEL was established at 25 mg/kg/day based on decreased
body weight and death.
7. Metsulfuron methyl did not induce gene mutation in bacteria
cells (Ames test). The chemical did cause chromosomal aberrations
in Chinese hamster chromosomes, with and without activation,
but was negative for chromosomal aberrations in a mouse micronucleus
assay. Metsulfuron methyl tested negative for genotoxic effects
in an unscheduled DNA synthesis assay (rat).
8. A metabolism study in rats demonstrates that metsulfuron
methyl is rapidly excreted in urine, primarily as the parent
A reference dose (RfD) of 0.25 mg/kg/day is established for
metsulfuron methyl based on the NOEL of 25 mg/kg/day from the
2-year feeding study in rats and a 100-fold uncertainty factor.
The theoretical maximum residue contribution (TMRC) from published
tolerances utilizes 0.3 percent of the RfD for the general U.S.
population. The proposed use on sugarcane would utilize an additional
0.01 percent of the RfD. The TMRC for the subpopulation most
highly exposed, nonnursing infants (less than 1-year old), utilizes
1.5 percent of the RfD based on published and proposed uses
of metsulfuron methyl.
The nature of the residue in sugarcane is adequately understood,
and an adequate analytical method, liquid chromatography, is
available for enforcement purposes. An analytical method for
enforcing this tolerance has been published in the Pesticide
Analytical Manual (PAM), Vol. II. Established tolerances are
adequate to cover secondary residues resulting from the use
of sugarcane and sugarcane byproducts as livestock feed commodities.
There are presently no actions pending against the continued
registration of this chemical.
Based on the above information considered by the Agency the
tolerance established by amending 40 CFR 180.428 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 document in the Federal Register
that this rulemaking proposal be referred to an Advisory Committee
in accordance with section 408(e) of the Federal Food, Drug,
and Cosmetic Act.
Interested persons are invited to submit written comments
on the proposed regulation. Comments must bear a notation indicating
the document control number, [PP 2E4094/P572]. All written comments
filed in response to this petition will be available in the
Public Response and Program Resources Branch, at the address
given above from 8 a.m. to 4 p.m., Monday through Friday, except
Under Executive Order 12866 (58 FR 51735, October 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, reveiw 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 entitlements, 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
Dated: November 24, 1993.
Stephen L. Johnson,
Acting Director, Registration Division, Office of Pesticide
Therefore, it is proposed that 40 CFR part 180 be amended
1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
2. In . 180.428, paragraph (a) table is amended by adding
and alphabetically inserting the raw agricultural commodity
sugarcane, to read as follows:
180.428 Metsulfuron methyl; tolerances for residues.
(a) * * *
Commodity Parts per
* * * * *
* * * * *
* * * * *
[FR Doc. 93-29831 Filed 12-7-93; 8:45 am]