[Federal Register Volume 59, Number 215 (Tuesday, November 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27704]
[[Page Unknown]]
[Federal Register: November 8, 1994]
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DEPARTMENT OF TRANSPORTATION
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300366; FRL-4919-4]
RIN 2070-AC18
Pesticide Tolerances for 2,3-Dihydro-2,2-Dimethyl-7-Benzofuranyl-
N-Methylcarbamate
AGENCY: Environmental Protection Agency.
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish a time-limited tolerance
for residues of the insecticide 2,3-dihydro-2,2-dimethyl-7-
benzofuranyl-N-methylcarbamate (common name ``carbofuran'') and its
metabolites in or on canola at 1.00 part per million (ppm) with an
expiration date of 2 years after the beginning of the effective date of
a final rule based on this proposal. EPA is issuing this proposal on
its own initiative.
DATES: Comments, identified by the document control number, [OPP-
300366], must be received on or before December 8, 1994.
ADDRESSES: Comments may be submitted to: Public Docket and Freedom of
Information Section, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20604. In person,
bring comments to: Rm. 1128, CM #2, Arlington, VA 22202. Information
submitted as a comment concerning this document may be claimed
confidential by marking any part or all of that information
``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 the EPA without prior notice. All written comments will be available
for public inspection in Rm. 1128 at the address given below, from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 207, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)-305-6386.
SUPPLEMENTARY INFORMATION: On its own initiative and pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e), EPA is proposing a time-limited, regionally restricted
tolerance for the residues of carbofuran on canola at 1.00 ppm. EPA is
proposing the tolerance because at the present time, canola treated
with carbofuran may not be processed in the U.S. and must be exported
to Canada. There are currently three Special Local Need registrations
under section 24(c) of the Federal Insecticide Fungicide, and
Rodenticide Act, 7 U.S.C. 136v(c). Registrations will be regionally
restricted to Idaho, Minnesota, Montana, North Dakota, and Washington.
All relevant materials have been evaluated. The toxicology data
considered in support of the tolerance include:
1. A 2-year chronic feeding/oncogenicity study in the rat with a
no-observed-effect level (NOEL) of 1.0 milligram (mg)/kilogram (kg) of
body weight (bwt) per day (20 ppm) for cholinesterase-inhibition (CHE)
and systemic effects, negative for oncogenic effects at the levels
tested (0, 10, 20, and 100 ppm).
2. A 2-year chronic feeding/oncogenicity study in the mouse with a
NOEL of 3.0 mg/kg bwt/day (20 ppm) for CHE, a NOEL of 18.75 mg/kg bwt/
day (125 ppm) for systemic effects, and negative for oncogenic effects
at all levels tested (0, 20, 125, and 500 ppm).
3. A 1-year dog feeding study with a NOEL of 0.5 mg/kg (20 ppm).
4. A three-generation rat reproduction study with a NOEL of 1.0 mg/
kg (20 ppm).
5. Two rat teratology studies which were negative for teratogenic
effects at up to 1.2 mg/kg bwt/day and 160 ppm and NOEL's for
fetotoxicity of 1.2 mg/kg and 60 ppm.
6. A rabbit teratology study which was negative for teratogenic and
fetotoxic effects at 2.00 mg/kg and mutagenicity testing which showed
carbofuran not to be mutagenic.
There is no cancer risk associated with the use of this chemical.
Carbofuran has not been shown to produce carcinogenic effects in two
species.
The reference dose (RfD), based on a 1-year dog feeding study with
a NOEL of 0.5 mg/kg bwt/day and an uncertainty factor of 100, is
calculated to be 0.005 mg/kg bwt/day. The theoretical maximum residue
contribution (TMRC) from the current tolerances is 0.005183 mg/kg/day.
The percent reference dose (RfD) for the overall U.S. population is
104%, for nonnursing infants it is 263%, and for children, ages 1-6, it
is 238%. The proposed tolerance will add 0.000077 mg/kg/day to the TMRC
and 1.5% to the overall RfD. The dietary risk from all uses of
carbofuran is overestimated since it was assumed that all residues are
at tolerance level (anticipated residues were not used) and 100% of all
crops were treated. Before any additional permanent tolerances will be
considered, the RfD must be refined by use of anticipated residues and
realistic percent crop treated values. The Agency will not establish
any new tolerances for carbofuran until the TMRCs for the overall U.S.
population and its subgroups are below the reference dose.
The tolerance would be established for 2 years, with an expiration
date of 2 years after the beginning of the effective date of a final
rule based on this proposal. The Interregional Research Project No. 4
(IR-4) is currently conducting new residue trials and plans to submit a
petition for a permanent tolerance in early 1995. However, because of
the known hazard to carbofuran to birds and wildlife, EPA will not
establish a permanent tolerance until the Agency has fully evaluated
risks to wildlife.
The nature of the residue in plants and animals is adequately
understood for the purposes of this time-limited tolerance. Adequate
analytical methods for enforcement are available in the Pesticide
Analytical Manual, Volume II (PAM II). Carbofuran, per se, is recovered
under FDA's multiresidue protocols A and D.
This pesticide is considered useful for the purposes for which the
tolerance is sought. Based on the above information considered by the
Agency, 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 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 FFDCA section 408(e).
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear notation indicating the
document control number, [OPP-300366]. All written comments filed in
response to this document will be available in the Public Docket and
Freedom of Information Section, at the address given above from 8 a.m.
to 4 p.m., Monday through Friday, except legal holidays.
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 exemptions from tolerance
requirements do not have a significant economic impact on a substantial
number of small entities. A certification statement of 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, Recording and
recordkeeping requirements.
Dated: October 27, 1994.
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 as follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.254, by adding new paragraph (c), to read as
follows:
Sec. 180.254 2,3-Dihydro-2,2-dimethyl-7-benzofuranyl-N-
methylcarbamate; tolerances for residues.
* * * * *
(c) A time-limited tolerance (of 2 years) with regional
registration, as defined in Sec. 180.1(n), is established for the
combined residues of the insecticide carbofuran (2,3-dihydro-2,2-
dimethyl-7-benzofuranyl-N-methylcarbamate), its carbamate metabolite-
2,3-dihydro-2,2-dimethyl-3-hydroxy-7-benzofuranyl-N-methylcarbamate,
and its phenolic metabolites 2,3-dihydro-2,2-dimethyl-7-benzofuranol,
2,3-dihydro-2,2-dimethyl-3-oxo-7-benzofuranol and 2,3-dihydro-2,2-
dimethyl-3,7-benzofurandiol in or on the following raw agricultural
commodity:
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Parts per
Commodity million
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Canola (of which no more than 0.2 ppm is carbamate)........ 1.00
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[FR Doc. 94-27704 Filed 11-3-94; 4:47 pm]
BILLING CODE 6560-50-F
