[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: [email protected]. 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: 
[email protected].

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-D[email protected]


    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