[Federal Register Volume 59, Number 41 (Wednesday, March 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4751]
[[Page Unknown]]
[Federal Register: March 2, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9E3752 and 9E3791/P575; FRL-4751-4]
RIN No. 2070-AC18
Pesticide Tolerances for Cyromazine
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for combined residues of
the insecticide cyromazine and its metabolite melamine in or on the raw
agricultural commodities Chinese cabbage and Chinese mustard. The
proposed regulation to establish maximum permissible levels for
residues of the insecticide was requested in petitions submitted by the
Interregional Research Project No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP 9E3752
and 9E3791/P575], must be received on or before April 1, 1994.
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
petitions (PP) 9E3752 and 9E3791 on behalf of the Agricultural
Experiment Station of Florida. These petitions requested 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 180.414 by
establishing tolerances for combined residues of the insecticide
cyromazine (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) and its
metabolite melamine (1,3,5-triazine-2,4,6-triamine), calculated as
cyromazine, in or on the raw agricultural commodities Chinese cabbage
(PP 9E3752) and Chinese mustard (PP 9E3791) at 3.0 parts per million
(ppm). The petitioner proposed that these uses of cyromazine be limited
to Florida 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 petitions and other relevant
material have been evaluated. A discussion of the toxicological data
considered in support of the proposed tolerances as well as a
discussion of the risk of cyromazine and its metabolite melamine can be
found in a rule (FAP 2H5355/P344) published in the Federal Register of
April 27, 1984 (49 FR 18120); in the Notice of Conditional Registration
for Larvadex 0.3% Premix, published in the Federal Register of May 15,
1985 (50 FR 20373); and in the proposed rule regarding the
establishment of a tolerance for residues of cyromazine and its
metabolite melamine, calculated as cyromazine, in or on mushrooms at
10.0 ppm in the Federal Register of June 30, 1993 (58 FR 34975).
A dietary exposure/risk assessment was performed for cyromazine
using a Reference Dose (RfD) of 0.0075 mg/kg body weight/day. The RfD
is based on a NOEL of 0.75 mg/kg/day from a 6-month feeding study in
dogs, which demonstrated decreased hematocrit and hemoglobin levels,
and an uncertainty factor of 100. The Theoretical Maximum Residue
Contribution (TMRC) from established tolerances for cyromazine utilizes
60 percent of the RfD for the overall U.S. population and 66 percent of
the RfD for children aged 1 through 6 years. This dietary exposure/risk
assessment includes tolerances for cyromazine on the cucurbit
vegetables and leafy vegetables (except Brassica) crop groupings, which
are published elsewhere in this issue of the Federal Register (document
control number PP 1F4016 and 2F4053/R2039). The proposed tolerances for
Chinese cabbage and Chinese mustard would utilize less than 1 percent
of the RfD for the overall U.S. population and approximately 1% of the
RfD for children aged 1 through 6 years. Since the risk estimates are
based on the TMRC, typically an overestimate of actual exposure, and do
not exceed the Reference Dose, the chronic dietary risk of cyromazine
does not appear to be of concern.
The nature of the residue in plants is adequately understood for
the purposes of these tolerances. An adequate analytical method, high-
pressure liquid chromatography, is available for enforcement purposes
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 or poultry feed items associated with this action.
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 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 9E3752 and 9E3791/P575]. All written
comments filed in response to these petitions 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 8, 1994.
Stephen L. Johnson,
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. 180.414, by adding new paragraph (f), to read as
follows:
Sec. 180.414 Cyromazine; tolerances for residues.
* * * * *
(f) Tolerances with regional registration, as defined in
Sec. 180.1(n), are established for the combined residues of the
insecticide cyromazine (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine)
and its metabolite melamine (1,3,5-triazine-2,4,6-triamine), calculated
as cyromazine, in or on the following raw agricultural commodities:
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Parts per
Commodity million
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Cabbage, Chinese........................................... 3.0
Mustard, Chinese........................................... 3.0
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[FR Doc. 94-4751 Filed 3-1-94; 8:45 am]
BILLING CODE 6560-50-F