[Federal Register Volume 59, Number 95 (Wednesday, May 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11990]
[[Page Unknown]]
[Federal Register: May 18, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 1F4029/R2059; FRL-4778-8]
RIN 2070-AB78
Pesticide Tolerances for Metsulfuron Methyl
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes increased tolerances for the combined
residues of the herbicide metsulfuron methyl (methyl 2-[[[[(4-methoxy-
6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-amino]sulfonyl]benzoate)
and its metabolite methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)amino]carbonyl]amino]sulfonyl]-4-hydroxybenzoate in or on the raw
agricultural commodities (RACs) wheat and barley grain at 0.1 part per
million (ppm) and wheat and barley straw at 0.3 ppm. This regulation
was requested by E.I. du Pont de Nemours & Co., Inc., and establishes
the maximum permissible levels for residues of the herbicide in or on
these raw RACs.
EFFECTIVE DATE: This regulation becomes effective May 18, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 1F4029/R2059], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. A copy of any objections and hearing
request filed with the Hearing Clerk should be identified by the
document control number and submitted 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 copy of objections and hearing
request to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail: Robert J. Taylor, Product
Manager (PM) 25, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: 1921 Jefferson Davis Hwy., Arlington, VA
22202, (703)-305-6800.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 11, 1992
(57 FR 8658), EPA issued a notice which announced that E.I. du Pont de
Nemours & Co. had submitted pesticide petition 1F4029 to EPA proposing
to establish a regulation under section 408 of the Federal Rood, Drug
and Cosmetic Act, 21 U.S.C. 346a, to permit residues of metsulfuron
methyl (methyl [[[[(4-methoxy-6-methyl-1,3,5-triazin-2yl)amino]
carbonyl]amino] sulfonyl]benzoate) and its metabolite methyl 2-[[[[(4-
methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-4-
hydroxybenzoate in or on wheat grain at 0.1 ppm, wheat straw at 0.3
ppm, barely grain at 0.1 ppm, and barley straw at 0.3 ppm.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data listed below were considered in
support of these tolerances.
1. Several acute studies placing technical-grade metsulfuron methyl
in Toxicity Categories III and IV.
2. A 21-day dermal study with rabbits at 125, 500, and 2,000
milligrams/kilograms/day (mg/kg) with a systemic no-observable-effect
level (NOEL) of 500 mg/kg/day for systemic effects based on occurrence
of diarrhea at 2,000 mg/kg, and a dermal irritation NOEL of 125 mg/kg/
day.
3. A 1-year feeding study in dogs fed dosages of 1, 1.25, 12.5, and
125 mg/kg/day with a NOEL of 1.25 mg/kg based on decreased serum lactic
dehydrogenase (LDH) at 12.5 mg/kg.
4. A 2-year chronic feeding/carcinogenicity study in rats fed
dosages of 0, 0.25, 1.25, 25, 125, and 250 mg/kg/day with no
carcinogenic effects observed under the conditions of the study at dose
levels up to and including 250 mg/kg/day (highest dose tested [HDT])
and a systemic NOEL of 25 mg/kg/day based on decreased body weight at
250 mg/kg/day.
5. An 18-month feeding/carcinogenicity study in mice fed dosages of
0, 0.75, 3.75, 75, 375, and 750 mg/kg/day with no carcinogenic effects
observed under the conditions of the study at dose levels up to and
including 750 mg/kg/day (HDT) and a systemic NOEL of 750 mg/kg/day
(HDT).
6. A developmental toxicity study in rats fed dosage levels of 0,
40, 250, and 1,000 mg/kg/day with a developmental NOEL of 1,000 mg/kg/
day (HDT) and a maternal NOEL of 40 mg/kg/day based on an increased
incidence of ``tip-toe walk'' at 250 mg/kg/day.
7. A developmental toxicity study in rabbits fed dosage levels of
0, 25, 100, 300, and 700 mg/kg/day with a developmental NOEL of 300 mg/
kg/day and a maternal NOEL of 25 mg/kg/day based on decreased body
weight at 100 mg/kg/day.
8. A two-generation reproduction study in rats fed 0, 1.25, 25, and
250 mg/kg/day with no reproductive effects at 250 mg/kg/day (HDT), a
maternal NOEL of 25 mg/kg/day based on decreased body weight gain at
250 mg/kg/day, and a NOEL for effects on offspring of 250 mg/kg/day
(HDT).
9. Mutagenic studies included an Ames Test, a chromosome
aberration/CHO study, a rat bone marrow/aberrations, and a mouse
micronucleus test (all negative).
The acceptable daily intake (ADI), based on a 2-year feeding study
with rats (NOEL of 25.0 mg/kg/body weight day) and using a hundredfold
safety factor, is calculated to be 0.25 mg/kg/day. The theoretical
maximum residue contribution (TMRC) for published tolerances is
0.000824 mg/kg/day for the overall U.S. population. The current action
will increase the TMRC by 0.000074 mg/kg bwt/day (0.1%) for the overall
U.S. population. For the U.S. subgroup population, nonnursing infants
less than 1-year old, the TMRC 0.000059 mg/kg bwt/day, which does not
raise the percentage of RfD. This tolerance and previously established
tolerances utilize 0.4% of the RfD for the overall U.S. population. For
the U.S. subgroup population, nonnursing infants less than a year old,
this tolerance and previously established tolerances utilize 1.5% of
the RfD, assuming that residue levels are at the established tolerances
and that 100 percent of the crop is treated.
Data lacking are a mutagenic study to fulfill the other genotoxic
effects requirement. The company has been notified of the deficiency
and has agreed to perform the study.
The pesticide is useful for the purposes for which these tolerances
are sought. The nature of the residue is adequately understood for the
purpose of establishing tolerances. Adequate analytical methodology,
high pressure liquid chromotography, is available for enforcement
purposes. The methods are listed in PAM II.
There are currently no actions pending against registration of this
chemical. The established tolerances for residues in meat and milk are
adequate to cover secondary residues from the proposed use.
Based on the information cited above, the Agency has determined
that the establishment of tolerances by amending 40 CFR part 180 will
protect the public health. Therefore, the tolerances are established as
set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing with the Hearing Clerk, at
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to
the OPP docket for this rulemaking. The objections submitted must
specify the provisions of the regulation deemed objectionable and the
grounds for the objections. 40 CFR 178.25. Each objection must be
accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is
requested, the objections must include a statement of the factual
issue(s) on which a hearing is requested, the requestor's contentions
on each such issue, and a summary of any evidence relied upon by the
objector. 40 CFR 178.27. A request for a hearing will be granted if the
Administrator determines that the material submitted shows the
following: There is a genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by the
requestor would, if established, resolve one or more of such issues in
favor of the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested. 40 CFR 178.32.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993) the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations of recipients
thereof; 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 the 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).
Lists of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 29, 1994.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is 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. 180.428(a), by amending the table therein by revising
the following entries, to read as follows:
Sec. 180.428 Metsulfuron methyl; tolerances for residues.
(a) * * *
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Parts per
Commodity million
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Barley, grain.............................................. 0.1
*****
Barley, straw.............................................. 0.3
*****
Wheat, grain............................................... 0.1
*****
Wheat, straw............................................... 0.3
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* * * * *
[FR Doc. 94-11990 Filed 5-17-94; 8:45 am]
BILLING CODE 6560-50-F