[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Proposed Rules]
[Pages 8615-8616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3385]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6E3460/P597; FRL-4932-2]
RIN 2070-AB78
Pesticide Tolerance for Prometryn
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to establish a tolerance for residues of the
herbicide prometryn in or on the raw agricultural commodity parsley.
The proposed regulation to establish a maximum permissible level 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 6E3460/
P597], must be received on or before March 17, 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 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) 6E3460 to EPA on behalf of the Agricultural Experiment
Station of California. 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 180.222 by establishing a
tolerance for residues of the herbicide prometryn (2,4-
bis(isopropylamino)-6-methylthio-s-triazine) in or on the raw
agricultural commodity parsley at 0.1 part per million (ppm). The
petitioner proposed that use of prometryn on parsley be limited to
California only based on the geographical representation of the residue
data submitted. Additional residue data will be required to expand the
area of usage. Persons seeking geographically broader registration
should contact the Agency's Registration Division at the address
provided above.
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. A 2-year feeding study with dogs fed diets containing 0, 15,
150, or 1,500 ppm (equivalent to 0, 0.375, 3.75, or 37.5 milligrams
(mg)/kilogram (kg)/day) with a no-observed-effect level (NOEL) of 150
ppm (3.75 mg/kg/day) based on degenerative hepatic changes, renal
tubule degeneration, and bone marrow atrophy at the 1,500-ppm dose
level.
2. A 104-week chronic feeding/carcinogenicity study with rats fed
diets containing 0, 10, 100, 750, or 1,500 ppm (equivalent to 0, 0.38,
3.90, 29.45, or 60.88 mg/kg/day for males and 0, 0.49, 4.91, 37.25, or
80.62 mg/kg/day for females) with a systemic NOEL of 750 ppm (29.45 mg/
kg/day in males and 37.25 mg/kg/day in females) based on decreased body
weight gain in both sexes, and renal lesions (mineralized concretions)
in males at the 1,500-ppm dose level. There were no carcinogenic
effects observed under the conditions of the study.
3. A carcinogenicity study with mice fed diets containing 0, 10,
1,000, or 3,000 ppm (equivalent to 0, 1, 100, or 300 mg/kg/day) for 102
weeks with a systemic NOEL of 1,000 ppm (100 mg/kg/day) based on
decreased body weight gain in female mice at the 3,000-ppm dose level.
There were no carcinogenic effects observed under the conditions of the
study.
4. A two-generation reproduction study in rats fed diets containing
0, 10, 750, or 1,500 ppm (equivalent to 0, 0.6, 47.8, 96.7 mg/kg/day in
males and 0, 0.7, 53.6, or 105.6 mg/kg day in females) with a NOEL for
reproductive effects of 10 ppm (0.6 mg/kg/day in males and 0.7 mg/kg/
day in females) based on decreased pup weight at the 750-ppm dose
level. The NOEL for parental systemic toxicity was also established at
10 ppm based on decreased food consumption, body weight, and body
weight gain at the 750-ppm dose level.
5. A developmental toxicity study in rabbits given gavage doses of
0, 2, 12, or 72 mg/kg/day with a NOEL of 12 mg/kg/day for maternal
toxicity based on decreased food consumption at the highest dose tested
(72 mg/kg/day). The NOEL for developmental effects was established at
12 mg/kg/day based on increased fetal resorption at the highest dose
tested.
6. A developmental toxicity study in rats given gavage doses of 0,
10, 50, or 250 mg/kg/day during gestational days 6 to 15 with a NOEL of
50 mg/kg/day for maternal toxicity based on salivation and decreases in
body weight and food consumption at the highest dose tested (250 mg/kg/
day). A NOEL for developmental toxicity was established at 50 mg/kg/day
based on decreased fetal body weight and increased incomplete
ossification of sternebrae and metacarpals at the 250-mg/kg/day dose
level.
7. Mutagenicity studies as follows: a gene mutation test (Ames
assay), negative up to cytotoxic solubility limits; structural
chromosome aberration tests, negative for anomalies in micronuclei in
bone marrow cells of [[Page 8616]] Chinese hamsters dosed orally at
5,000 mg/kg; and tests for other genotoxic effects, negative for
unscheduled DNA synthesis in rat hepatocytes up to cytotoxic levels.
8. In a general metabolism study using rats fed diets containing
radio-labelled prometryn, prometryn was extensively metabolized with
less than 2 percent of the recovered 14C radioactivity representing the
parent compound. Prometryn is excreted predominately in the urine and
feces.
The Reference Dose (RfD) for prometryn is established at 0.04 mg/kg
of body weight (bwt)/day, based on a NOEL of 3.75 mg/kg/day from the 2-
year feeding study in dogs and an uncertainty factor of 100. The
Theoretical Maximum Residue Contribution (TMRC) from established
tolerances and the current action is estimated at 0.000181 mg/kg of
body weight/day and utilizes less than 1 percent of the RfD for the
U.S. population. The most highly exposed subgroup (children of ages 1
through 6 years) will be exposed to less than 1 percent of the RfD from
existing uses and the proposed use on parsley.
An acute dietary exposure analysis was conducted for prometryn
based on a NOEL of 12 mg/kg/day from the rabbit developmental toxicity
study. In the analysis, tolerance level residues were used to calculate
the high-end exposure for females older than 13 years, which
approximates women of child-bearing age. High-end dietary exposure was
compared to the NOEL of 12 mg/kg/day to obtain a high-end Margin of
Exposure (MOE) of 10,000. The Agency concludes there is no acute
dietary concern for prometryn at this time.
The nature of residue in plants is adequately understood for the
purposes of the proposed tolerance. An adequate analytical method, gas
chromatography, is available for enforcement purposes. The analytical
method for enforcing this tolerance has been published in the Pesticide
Analytical Manual, Vol. II (PAM II).
There is no reasonable expectation that secondary residues will
occur in milk, eggs, or meat of livestock and poultry, since there are
no livestock feed items associated with this action.
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 tolerance established by amending 40 CFR part 180
would protect the public health. 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 6E3460/P597]. 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: January 30, 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. 180.222, paragraph (b) is amended in the table therein
by adding and alphabetically inserting a new entry, to read as follows:
Sec. 180.222 Prometryn; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Parsley.................................................... 0.1
------------------------------------------------------------------------
[FR Doc. 95-3385 Filed 2-14-95; 8:45 am]
BILLING CODE 6560-50-F
