[Federal Register Volume 60, Number 143 (Wednesday, July 26, 1995)]
[Proposed Rules]
[Pages 38295-38297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18001]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F2792/P622; FRL-4966-2]
RIN 2070-AC18
Pesticide Tolerance for Pendimethalin
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for the combined residues
of the herbicide pendimethalin (N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine) and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol in or on the raw agricultural
commodities pea pods, shelled peas, pea vines, and peas plus pods each
at 0.1 part per million (ppm). The American Cyanamid Co. requested this
proposed regulation to establish a maximum permissible level for
residues of the herbicide in a petition submitted under the Federal
Food, Drug and Cosmetic Act (FFDCA).
DATES: Comments, identified by the document control number [PP 3F2792/
P622], must be received on or before August 25, 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. 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 4:30 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [PP 3F2792/P622]. No Confidential Business
Information (CBI) should be submitted through e-mail. Electronic
comments on this proposed rule may be filed online at many Federal
Depository Libraries. Additional information on electronic submissions
can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Robert Taylor, Product
Manager (PM) 25, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St. SW., Washington,
DC 20460. Office location and telephone number: Rm. 241, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6800; e-mail:
taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of January 1, 1983 (48 FR 1350), which announced that
American Cyanamid Co. had submitted pesticide petition (PP) 3F2792 to
EPA requesting that the Administrator, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
amend 40 CFR 180.361 by establishing a tolerance for the combined
residues of the herbicide pendimethalin, in or on the raw agricultural
commodities pea pods, shelled peas, pea vines, and peas plus pods each
at 0.1 part per million (ppm). There were no comments or requests for
referral to an advisory committee received in response to the notice of
filing.
The petitioner subsequently amended the petition and proposed to
establish a tolerance for the combined residues of pendimethalin and
its metabolite in or on the raw agricultural commodities of the legume
vegetables (succulent or dried) group at 0.1 ppm and in or on the
foliage of legume vegetables group at 0.1 ppm. The petition was later
revised to propose tolerances for the combined residues of
pendimethalin and its metabolite in or on peas (except field peas)
pursuant to 40 CFR 180.1(h).
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. Results of acute oral, dermal and inhalation studies, primary
eye irritation studies, and primary dermal irritation and sensitization
studies placing technical-grade pendimethalin in Toxicity Category III.
2. A subchronic feeding study with rats fed dosages of 0, 10, 50,
or 500 milligrams/kilogram/day (mg/kg/day) with no-observable-effect
level (NOEL) of 50 mg/kg/day based on decreased hematocrit and
hemoglobin levels in males, decreased body weight gain and food
consumption, and hypertrophy of the liver accompanied by increased
liver weights at 500 mg/kg/day.
3. A chronic feeding study in dogs fed dosages of 0, 12.5, 50, or
200 mg/kg/day with a NOEL of 12.5 mg/kg/day based on an increase in
serum alkaline phosphatase and increased liver weights and hepatic
lesions at 50 mg/kg/day.
4. A chronic feeding/carcinogenicity study in rats fed dosages of
0, 5, 25, or 50 mg/kg/day with a statistically significant increased
trend and pairwise comparison between the high-dosed group and the
control for thyroid follicular cell adenomas in male and female rats.
The systemic NOEL is 5 mg/kg/day based on pigmentation of thyroid
follicular cells in males and females.
5. A carcinogenicity study in male mice fed dosages of 0, 12.3,
62.3, or 622.1 mg/kg/day or female mice fed dosages of 0, 15.6, 783, or
806.9 mg/kg/day with no carcinogenic effects observed under the
conditions of the study up to 622.1 mg/kg/day (highest dose tested
[HDT]) in male mice or up to 806.9 mg/kg/day (HDT) in female mice.
6. A developmental toxicity study with rats fed dosages of 0, 125,
250, or 500 mg/kg/day with a developmental NOEL greater than 500 mg/kg/
day (HDT) and a maternal NOEL greater than 500 mg/kg/day (HDT).
7. A developmental toxicity study with rabbits fed dosages of 0,
15, 30, or 60 mg/kg/day with a maternal and developmental NOEL greater
than 60 mg/kg/day (HDT).
[[Page 38296]]
8. A two-generation reproduction study with rats fed dosages of 0,
34, 172, or 346 mg/kg/day (males) and 0, 43, 216, or 436 mg/kg/day
(females) with a reproductive NOEL of 43 mg/kg/day based on a decrease
in pup weight at 216 mg/kg/day. The parental NOEL is 34 mg/kg/day based
on decreased body weight and food consumption at 172 mg/kg/day.
9. Mutagenicity data included assays with Salmonella typhimurium
(positive in strains TA 1538 and TA 98 with metabolic activation); an
in vitro cytogenetics-CHO assay (negative up to 25 ug/plate without
metabolic activation and 100 ug/mL with activation); and an unscheduled
DNA synthesis (negative between 30 and 3,000 ug/well). A micronucleus
assay in mice was negative at 625 and 1,250 mg/kg.
The Health Effects Division Carcinogenicity Peer Review Committee
(PRC) evaluated the toxicology data for carcinogenic potential. The PRC
classified pendimethalin as a Group C-possible human carcinogen and
recommended that for quantification of human risk, the Reference Dose
(RfD) approach should be used. This decision was based on statistically
significant increased trend and pairwise comparison between the high-
dose group and controls for thyroid follicular cell adenomas in male
and female rats. This study was conducted using adequate doses for the
determination of carcinogenic activity. Pendimethalin induces gene
mutations, but not aberrations or DNA damage/repair, based on
acceptable studies. Structurally related compounds showed evidence of
tumorigenic activity.
Based on the NOEL of 12.5 mg/kg/day (2-year dog-feeding study) and
an uncertainty factor of 300, the RfD (reference dose) for
pendimethalin is calculated to be 0.04 mg/kg/body weigh/day (bwt). The
theoretical maximum residue contribution (TMRC) is 3.11 X 10-4 mg/
kg bwt/day for existing tolerances for the overall U.S. population. The
current action will increase the TMRC by 1.8 X 10-5 mg/kg bwt/day
or 0.04 percent of the RfD. This tolerance and previously established
tolerances utilize 0.8 percent of the RfD. The subgroup most highly
exposed, children ages 1 through 6, has a TMRC from published and
proposed uses of 7.2 X 10-4 mg/kg bwt/day or 1.8 percent of the
RfD, assuming that residue levels are at the established tolerances and
100 percent of the crop is treated.
There are no desirable data lacking and no pending regulations
against the continuing registration of this chemical. The chronic
dietary risk from this chemical appears to be minimal, particularly
since none of the U.S. population subgroups has an exposure greater
than 2 percent of the RfD.
The nature of the residues in plants and animals is adequately
understood, and adequate analytical methodology (GLC using a 63Ni
electron capture detector) is available for enforcement and has been
published in the Pesticide Analytical Method (PAM), Method I. There is
no expectation that secondary residues will occur in meat, milk,
poultry, or eggs from this use.
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. The pesticide is considered useful for
the purpose for which it is intended. 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 3F2792/P622]. 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
4:30 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP 3F2792/P622] (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, 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
[[Page 38297]]
and pests, Reporting and recordkeeping requirements.
Dated: July 10, 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. In Sec. 180.361, paragraph (a) is amended in the table therein
by adding and alphabetically inserting the following commodity, to read
as follows:
Sec. 180.361 Pendimethalin; tolerances for residues.
(a) * * *
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Parts per
Commodity million
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* * * * *
Peas (except field peas)................................... 0.1
* * * * *
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[FR Doc. 95-18001 Filed 7-25-95; 8:45 am]
BILLING CODE 6560-50-F
