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Clopyralid - Proposed Pesticide Tolerance 9/95

[Federal Register: September 29, 1995 (Volume 60, Number 189)]
[Rules and Regulations]
[Page 50426-50430]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 1E3979/P632; FRL-4977-6]
RIN 2070-AC18
Clopyralid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for residues of the
herbicide clopyralid in or on the raw agricultural commodity asparagus.
The proposed regulation to establish a maximum permissible level for
residues of the herbicide was requested in a petition submitted under
the Federal Food, Drug and Cosmetic Act (FFDCA) by the Interregional
Research Project No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP 1E3979/P632],
must be received on or before October 30, 1995.
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 22202. Comments and data may
also be submitted to OPP 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 1E3979/P632]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found in the "SUPPLEMENTARY INFORMATION" section of this document.
    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.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
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 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) 1E3979 to EPA on behalf of the Agricultural Experiment
Stations of Arkansas, California, Maryland, Michigan, Minnesota, and
Washington. The 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 180.431 by establishing a tolerance for
residues of the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic
acid) in or on the raw agricultural commodity asparagus at 1.0 part per
million (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 in dogs, which were fed diets containing
0, 100, 320, and 1,000 milligrams (mg)/kilogram (kg)/day, with a no-
observed-effect-level (NOEL) of 100 mg/kg/day. The lowest-observed-
effect level (LOEL) was established at 320 mg/kg/day based on increased
liver weights and decreased erythrocyte counts and hemoglobin and
hematocrit values.
    2. A developmental toxicity study in rats, which was given the
chemical by gavage at doses of 0, 15, 75, and 250 mg/kg, with no
developmental toxicity observed under the conditions of the study. The
NOEL for maternal toxicity was established at 75 mg/kg based on
decreased body weight and reduced food consumption at the LOEL (250 mg/
kg/day).
    3. A developmental toxicity study in rabbits, which was given the
chemical by gavage at doses of 110 and 250 mg/kg, with no developmental
or maternal toxicity observed under the conditions of the study.
    4. A 2-year chronic feeding/carcinogenicity study in mice, which
were fed diets containing 0, 100, 500, and 2,000 mg/kg/day, with a NOEL
for systemic effects of 500 mg/kg. Decreased body weight was observed
in male mice fed 2,000 mg/kg/day (LOEL). No carcinogenic effects were
observed under the conditions of the study.
    5. A 2-year chronic feeding/carcinogenicity study in rats fed diets
containing 0, 5, 15, 50, and 150 mg/kg/day with a NOEL for systemic
effects of 50 mg/kg/day. The LOEL was established at 150 mg/kg/day
based on decreased mean body weight in females in the high-dose group.
No carcinogenic effects were observed under the conditions of the
study.
    6. A two-generation reproduction study in rats fed diets containing
0, 150, 500, and 1,500 mg/kg/day with no observed effect on
reproductive performance. A systemic NOEL of 500 mg/kg/day was
established for the study based on reduced terminal body weight in the
F0 generation at the 1,500 mg/kg/day level.
    7. Mutagenicity studies including dominant-lethal assay in rats, in
vivo rat cytogenetic, in vitro Salmonella and Saccharomyces assays, in
vivo mouse host-mediated assay, and an unscheduled DNA synthesis assay,
which were all negative.
    8. In a metabolism study in rats, radio-labeled clopyralid was
readily absorbed after being ingested and the majority of the
radioactive dose was excreted within 24 hours of ingestion.
    The reference dose (RfD) for clopyralid is established at 0.5 mg/kg
body weight (bwt)/day. The RfD is based on a NOEL of 50 mg/kg/bwt/day
from the 2-year feeding study in rats and an uncertainty factor of 100.
The theoretical maximum residue contribution (TMRC) from established
tolerances utilizes less than 2 percent of the RfD for the overall U.S.
population. The TMRC for the subgroup most highly exposed, children
aged 1 to 6 years, utilizes less than 4 percent of the RfD. The dietary
risk assessment indicates that there is no appreciable risk from
establishment of the proposed tolerance for asparagus.
    The nature of the residue in plants is adequately understood. The
residue of concern is parent clopyralid. An adequate analytical method,
gas chromatography, is available for enforcement purposes. Because of
the long lead time from establishing these tolerances to publication of
the enforcement method in the Pesticide Analytical Manual, the
analytical method is being made available, in the interim, to anyone
with an interest in pesticide enforcement when requested from: Calvin
Furlow, Public Response and Program Resources Branch, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 1132, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA 22202, (703)-305-5937.
    No secondary residues are expected to occur in milk, eggs, or meat
as a result of this use; asparagus is not considered a livestock feed
commodity.
    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 document in the Federal Register that this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the FFDCA.
    Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [PP 1E3979/P632].
    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.
    A record has been established for this rulemaking under docket
number [PP 1E3979/P632] (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 Rm. 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    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: September 20, 1995.
Peter Caulkins,
Acting 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. Section 180.431 is amended in paragraph (a) in the table therein
by adding and alphabetically inserting an entry for the commodity
asparagus, to read as follows:
Sec. 180.431   Clopyralid; tolerances for residues.
    (a) *  *  *
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                                      Parts per
 Commodity                             million
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Asparagus............. .......          1.0

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