[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]


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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.

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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) *  *  *

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                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                                  *****                                 
Cucurbit vegetables........................................          2.0
Leafy vegetables (except Brassica).........................         10.0
                                                                        
                                  *****                                 
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[FR Doc. 94-4750 Filed 3-1-94; 8:45 am]
BILLING CODE 6560-50-F