[Federal Register Volume 60, Number 50 (Wednesday, March 15, 1995)]
[Proposed Rules]
[Pages 13939-13941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6418]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 4E4359/P604; FRL-4936-3]
RIN 2070-AC18


Pesticide Tolerance for Paraquat

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish tolerances for residues of the 
desiccant, defoliant, and herbicide paraquat in or on the raw 
agricultural commodities lentils, lentil forage, and lentil hay. The 
proposed regulation to establish maximum permissible levels for 
residues of the herbicide was requested in a petition submitted by the 
Interregional Research Project No. 4 (IR-4).

DATES: Comments, identified by the document control number, [PP 4E4359/
P604], must be received on or before April 14, 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 notice 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 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.

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) 4E4359 to EPA on behalf of the Agricultural Experiment 
Stations of Idaho and Washington. This 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 180.205 by 
establishing tolerances for residues of paraquat (1,1'-dimethyl-4,4'- 
[[Page 13940]] bipyridinium-ion) derived from application of either the 
bis (methyl sulfate) or the dichloride salt (both calculated as the 
cation), in or on the raw agricultural commodities lentils at 0.3 part 
per million (ppm), lentil forage at 0.1 ppm, and lentil hay at 0.4 ppm.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. The toxicological data considered in 
support of the proposed tolerances include:
    1. A 1-year feeding study in dogs fed diets containing 0, 15, 30, 
and 50 ppm (equivalent to 0, 0.45, 0.93, and 1.51 milligrams/kilogram 
(mg/kg) of body weight (bwt) day with a no-observed-effect level (NOEL) 
of 15 ppm (0.45 mg/kg/day) based on increased severity and extent of 
chronic pneumonitis in both sexes, especially males, at the 30-ppm dose 
level.
    2. A 23-month chronic feeding/carcinogenicity study in mice fed 
diets containing 12.5, 37.5, and 100/125 ppm paraquat ion (the highest 
dose tested (HDT) was increased from 100 to 125 ppm at week 36) with a 
systemic NOEL of 12.5 ppm (equivalent to 1.87 mg/kg/day) based on renal 
tubular degeneration in male mice, and weight loss and decreased food 
intake in female mice. There were no carcinogenic effects observed 
under the conditions of the study.
    3. A 2-year chronic feeding/carcinogenicity study in Fischer rats 
fed diets containing 0, 1.25, 3.75, and 7.5 mg/kg/day with equivocal 
(uncertain) evidence of carcinogenicity (squamous cell carcinomas) in 
the head region (ear, nasal cavity, oral cavity, and skin) of male rats 
of the highest dose level group, and an approximate systemic NOEL of 
1.25 mg/kg/day based on incidence of opacities, cataracts, and 
nonneoplastic lung lesions (alveolar macrophages and epithelialization 
and slight peribronchiolar lymphoid hyperplasia). The squamous cell 
carcinomas were not associated with oral exposure, but were the result 
of topical exposure (through powdered diet).
    4. A 2-year chronic feeding/carcinogenicity study in Wistar rats 
fed diets containing 6, 30, 100, and 300 ppm (paraquat dichloride) with 
a systemic NOEL of 100 ppm (equivalent to 5 mg/kg/day) based on 
increased mortality in males and females; decreased erythrocytes, 
hemoglobin, and serum protein in males and females; decreased 
hematocrit, glucose and corpuscular cholinesterase activity in males; 
decreased leukocytes, albumin-to-globulin ratio, and alkaline 
phosphatase; increased polymorphonucleocytes in males; increased 
potassium and glucose in females; decreased absolute and/or relative 
weights of heart (males and females), liver and brain (females); and 
increased absolute weights of kidneys (males and females) at the 
highest dose tested (HDT) (equivalent to 15 mg/kg/day). There was no 
evidence of carcinogenicity observed under the conditions of the study.
    5. A developmental toxicity study in rats given gavage dosages of 
1, 5, and 10 mg paraquat ion/kg of body weight from day 6 through day 
15 of pregnancy with NOEL's for fetotoxic effects and maternal toxicity 
of 1.0 mg/kg/day. The lowest effect level (LEL) was established at 5 
mg/kg/day based on weight reduction and slight retardation in 
ossification (fetotoxicty) and piloerection, weight loss, and hunched 
appearance (maternal toxicity).
    6. A developmental toxicity study in mice given gavage dosages of 
1, 5, and 10 mg/kg/day with no developmental toxicity observed under 
the conditions of the study at any dosage level tested.
    7. A three-generation reproduction study with rats fed diets 
containing 25, 75, and 150 ppm with a systemic NOEL of 25 ppm 
(equivalent to 1.25 mg/kg/day) based on an increased incidence of 
alveolar histiocytosis in the lungs of male and female parents. There 
were no reproductive effects observed under the conditions of the 
study.
    8. Paraquat was negative in 10 mutagenicity studies (mostly gene 
mutation and chromosome aberration studies and one DNA damage/repair 
assay); weakly positive in four studies (two gene mutation, one 
chromosome aberration, and one DNA damage/repair assay); and positive 
in four studies (all DNA damage/repair assays).
    The Agency (Peer Review Committee) initially classified paraquat as 
a category ``C'' carcinogen based on the significant increase of 
squamous cell carcinomas in the head region of the high-dose males in 
the Fisher rat chronic feeding/carcinogenicity study. Review of the 
study by an independent laboratory concluded that those tumor sites 
should not be combined; without the combination, there were no 
statistically significant tumor increases for any particular tumor 
type. Discussion and review by the Agency (Peer Review Committee) 
concluded that these tumor sites normally should not be combined when 
the exposure to the chemical is by the oral route and that these tumors 
are likely the result of topical exposure to paraquat contained in the 
powdered diet (paraquat is a topical irritant), not the result of 
exposure through the gastrointestinal tract. The Agency considered two 
additional studies (rat and mouse carcinogenicity studies) and further 
evaluated the tumors in the male rats. Based on all the information, 
the Agency concluded that there is no evidence of carcinogenicity in 
male Wistar rats at 12 mg/kg/day (HDT) and female Wistar rats at 15 mg/
kg/day. The Agency concluded that there was at best equivocal evidence 
of carcinogenicity in male Fisher rats at 7.5 mg/kg/day and that this 
equivocal evidence was associated with irritation due to topical 
exposure, and not with oral exposure. Paraquat was, therefore, placed 
in Category E (not a human carcinogen). Because paraquat is a 
restricted-use pesticide and precautionary measures are required to 
protect applicators from the acute toxicity of the chemical, the 
potential for carcinogenic effects by excessive (irritating) topical 
exposure is not a concern for applicators.
    The reference dose (RfD) is established at 0.0045 mg/kg body 
weight/day based on a NOEL of 0.45 mg/kg/day from the 1-year dog study 
and an uncertainity factor of 100. The theoretical maximum residue 
contribution (TMRC) from existing uses of paraquat utilizes 42% of the 
RfD for the general U.S. population, or 95.7% of the RfD for children, 
aged 1 to 6 years old (the population subgroup most highly exposed). 
The proposed tolerance for lentils would utilize 0.008% of the RfD for 
the U.S. population, or 0.007% of the RfD for children, aged 1 to 6 
years.
    The nature of the residue is adequately understood for the purpose 
of these tolerances. An adequate analytical method is available for 
enforcement purposes. The analytical method for enforcing these 
tolerances has been published in the Pesticide Analytical Manual, Vol. 
II (PAM II). Any secondary residues in milk, eggs, or meat of livestock 
and poultry will fall within existing tolerances for these commodities.
    There are currently no actions pending against the continued 
registration of this chemical.
    Based on the information and data considered, the Agency has 
determined that the tolerances established by amending 40 CFR part 180 
would protect the public health. Therefore, it is proposed that the 
tolerances 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 
[[Page 13941]] 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 4E4359/P604]. 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 p.m., Monday through Friday, except legal holidays.
    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: February 28, 1995.

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 to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. In Sec. 180.205, paragraph (a) is amended in the table therein 
by adding and alphabetically inserting the raw agricultural commodities 
lentils, lentil forage, and lentil hay, to read as follows:


Sec. 180.205   Paraquat; tolerances for residues.

    (a) *  *  *

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                                                              Parts per 
                         Commodity                             million  
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                  *        *        *        *        *                 
Lentils....................................................          0.3
Lentil, forage.............................................          0.1
Lentil, hay................................................          0.4
                                                                        
                  *        *        *        *        *                 
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[FR Doc. 95-6418 Filed 3-14-95; 8:45 am]
BILLING CODE 6560-50-F