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Pendimethalin - Proposed Tolerance 7/95

[Federal Register: July 26, 1995 (Volume 60, Number 143)] [Proposed Rules]
[Page 38295-38297]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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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
weight/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
-----------------------------------------------------
*	*	*	*	*
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