[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: 94-4750]
[[Page Unknown]]
[Federal Register: March 2, 1994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 1F4016 and PP 2F4053/R2039; FRL-4756-8]
RIN 2070-AB78
Pesticide Tolerances for Cyromazine
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule establishes tolerances for residues of the insect
growth regulator 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 leafy vegetables (except Brassica)
at 10.0 ppm and in or on cucurbits vegetables at 2.0 ppm. This
regulation to establish maximum permissible levels for residues of the
insecticide was requested pursuant to petitions submitted by Ciba-Geigy
Corp.
EFFECTIVE DATE: This regulation becomes effective March 2, 1994.
ADDRESSES: Written objections, identified by the document control
number, [PP 1F4016 and PP 2F4053/R2039], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
document control number and submitted 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 copy of objections and hearing
request to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail: Phillip O. Hutton, Product
Manager (PM 18), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 202, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, 703-557-2386.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 11, 1992
(57 FR 8658 -8659), EPA issued notices which announced that Ciba-Geigy
Corp., P.O. box 18300, Greensboro, NC 27419, had submitted pesticide
petitions (PP 1F4016 and PP 2F4039) to EPA proposing to amend 40 CFR
180.414 by establishing tolerances, under section 408 of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, for residues of the
insecticide cyromazine (N-cyclo-propyl-1,3,5-triazine-2,4,6-triamine)
plus its major metabolite melamine (1,3,5-triazine-2,4,6-triamine) in
or on the raw agricultural commodities leafy vegetables crop group at
10.0 ppm and cucurbit vegetables crop group at 2.0 ppm.
There were no comments or requests for referral to an advisory
committee received in response to these notices of filing. The
scientific data submitted in the petition and other relevant material
have been evaluated. A discussion of the toxicological data considered
in support of the tolerance 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 34972).
A chronic dietary exposure/risk assessment for the proposed use on
cucurbit vegetables and leafy vegetables (except Brassica) based on
tolerance residue levels of 2.0 ppm and 10.0 ppm, respectively, was
performed. This chronic analysis compared exposure estimates to a
Reference Dose (RfD) of 0.0075 mg/kg/ body weight/day based on a no-
observable-effects level (NOEL) of 0.75 mg/kg body weight/day and an
uncertainty factor of 100. The NOEL is based on a 6-month dog feeding
study which demonstrated decreased hematocrit and hemoglobin levels.
The Theoretical Maximum Residue Contribution (TMRC) from established
tolerances for cyromazine utilizes 30% of the RfD for the overall U.S.
population. With the inclusion of leafy vegetables (except Brassica)
and cucurbit vegetables, dietary risk is raised to 60 percent of the
RfD. Therefore, the contribution of the leafy vegetables (except
Brassica) and cucurbit vegetables tolerances takes up an additional 30
percent of the RfD. Further, with the inclusion of the leafy vegetables
(except Brassica) and cucurbit vegetables, the estimates for the total
percent RfD occupied for infants aged less than 1 year and children 1
through 6 years of age become 44% and 66%, respectively. Since the
exposure estimates are based on theoretically maximum residues, and are
typically overestimates of actual exposure, and since they 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 chromatograph with UV detection, 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 asssociated with this action.
Based on the information cited above, the Agency has determined
that the establishment of the tolerance by amending 40 CFR part 180
will protect the public health. The pesticide is considered useful for
the purposes for which the tolerances are sought and capable of
achieving the intended physical or technical effect. Therefore, the
tolerance is established as set forth below.
Any person adversely affected by these regulations may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing with the Hearing Clerk, at
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to
the OPP docket for this rulemaking. The objections submitted must
specify the provisions of the regulation deemed objectionable and the
grounds for the objections (40 CFR 178.25). Each objection must be
accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is
requested, the objections must include a statement of the factual
issue(s) on which a hearing is requested, the requestor's contentions
on such issues, and a summary of any evidence relied upon by the
objector (40 CFR 178.27). A request for a hearing will be granted if
the Administrator determines that the material submitted shows the
following: There is a genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by the
requestor would, if established, resolve one or more of such issues in
favor of the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations or recipients
thereof; 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 the 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 22, 1994.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. By amending Sec. 180.414(e) in the table therein by adding and
alphabetically inserting the following entries, to read as follows:
Sec. 180.414 Cyromazine; tolerances for residues.
* * * * *
(e) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
*****
Cucurbit vegetables........................................ 2.0
Leafy vegetables (except Brassica)......................... 10.0
*****
------------------------------------------------------------------------
[FR Doc. 94-4750 Filed 3-1-94; 8:45 am]
BILLING CODE 6560-50-F