[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