[Federal Register Volume 61, Number 87 (Friday, May 3, 1996)]
[Rules and Regulations]
[Pages 19842-19845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10922]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 6F3333 and FAP2H5640/R2234; FRL-5365-6]
RIN 2070-AB78


Cyromazine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: This rule establishes a tolerance for combined residues of the 
insecticide cyromazine (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) 
and its major metabolite melamine, 1,3,5-triazine-2,4-6-triamine 
calculated as cyromazine in or on the raw agricultural commodity (RAC) 
tomato. The regulation to establish a maximum permissible level for 
residues of the insecticide was requested in a petition submitted by 
the CIBA-Geigy Corporation, P.O. Box 18300, Greensboro, NC 27419.

 EFFECTIVE DATE: This regulation becomes effective May 3, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 6F3333 and FAP2H5640/R2234], 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 requests 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. An electronic copy of objections and hearing 
requests filed with the Hearing Clerk may be submitted to OPP by 
sending electronic mail (e-mail) to: [email protected].
    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic objections and hearing 
requests must be identified by the docket number [PP 6F3333 and

[[Page 19843]]

FAP2H5640/R2234]. No Confidential Business Information (CBI) should be 
submitted through e-mail. Copies of electronic objections and hearing 
requests on this rule may be filed online at many Federal Depository 
Libraries. Additional information on electronic submissions can be 
found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: George LaRocca, Product 
Manager (PM) [13], Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 204, CM#2, 1921 
Jefferson Davis Highway, Arlington, VA 22202. (703) 305-6100; e-mail: 
[email protected]
SUPPLEMENTARY INFORMATION: In the Federal Register of March 19, 1986 
(51 FR 9511) and June 10, 1992 (57 FR 2467) EPA issued notices of 
filing which announced that Ciba-Geigy Corp. (CIBA), P.O. Box 18300, 
Greensboro, NC 27419 had submitted pesticide petition (PP 6F3333) and 
Food/Feed Additive Petition (FAP) 2H5640 to EPA proposing to amend 40 
CFR 180.414 by establishing a tolerance under section 408 (d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, for 
residues of the insecticide cyromazine (N-cyclopropyl-1,3,5-triazine-
2,4,6-triamine) plus its major metabolite melamine, 1,3,5-triazine-2,4-
6-triamine calculated as cyromazine in or on the raw agricultural 
commodity tomato at 1.0 parts per million (ppm) and proposing to amend 
40 CFR parts 185 and 186 by establishing a food/feed additive 
regulation under section 409(e) of FEDCA 21 U.S.C. 348(b) for combined 
residues of cyromazine and its metabolite in/on processed tomato 
products at 1.2 ppm and dried tomato pomace at 1.6 ppm. Further in the 
Federal Register of March 10, 1993 (58 FR 13261), Ciba amended PP 
6F3333 by lowering the tolerance for combined residues of the 
insecticide cyromazine plus its metabolite melamine, in or on the raw 
agricultural commodity tomato from 1.0 ppm to 0.5 ppm. The petitions 
for tomato and processed tomato products were again amended in the 
Federal Register of October 25, 1995 (60 FR 54689) by proposing to 
raise the tolerance in tomatoes to 1.0 ppm and proposing tolerances in 
or on processed tomato products (excluding juice) at 2.5 ppm and tomato 
pomace, wet and dry at 2.5 ppm. In addition Ciba proposed to amend 40 
CFR 180.414 by:
    (1) Establishing separate tolerances for residues of cyromazine and 
its major metabolite melamine, calculated as cyromazine, in meat, fat, 
and meat by-products (including liver and kidney) of cattle, goats, 
hogs, horses, and sheep at 0.05 ppm and milk at 0.02 ppm under Sections 
180.414(b) and (c) respectively.
    (2) Establish as a separate tolerance for residues of the 
metabolite 1- methylcyromazine (1-methyl-N-cyclopropyl-1,3,5-triazine-
2,4,6- triamine), calculated as cyromazine, in liver and kidney of 
cattle, goats, hogs, horses and sheep at 0.05 ppm, and
    (3) Amending the established tolerances for cyromazine and melamine 
in or on fat, meat and meat-by-products of chickens, under 40 CFR 
180.414 (b) and (c) by removal of the restriction ``from chicken layer 
hens and chicken breeder hens only''.
    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 
(48 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 mushroom at 10.0 ppm in the Federal 
Register of June 30, 1993 (58 FR 34972).
    A chronic dietary exposure/risk assessment has been performed for 
cyromazine using a reference dose (RfD) of 0.0075 mg/kg bwt/day. The 
reference dose is based on the no-observable-effect-level (NOEL) of 
0.75 mg/kg bwt/day from a 6-month dog feeding study with an uncertainty 
factor (UF) of 100 that demonstrated decreased hematocrit and 
hemoglobin levels. Granting the tolerance on tomato will increase the 
theoretical maximum residue contribution (TMRC) for the overall 
(average) U.S. population for cyromazine from 0.001788 mg/kg/day to 
0.002011 mg/kg/day. The percentage of the RfD used is increased from 24 
percent to approximately 26.8%. Generally speaking the Agency has no 
concern if dietary exposure is less than the Rfd for all published and 
proposed tolerances.
    Cyromazine was previously classified by the Agency as a Group C-
possible human carcinogen, with the Reference Dose (RfD) methodology 
recommended for estimation of human risk (see the Federal Register of 
June 30, 1993 (58 FR 34972)). Ciba subsequently submitted a 
reexamination (by a reviewing pathologist and a pathology working 
group) of the tissues from the cyromazine chronic feeding and 
carcinogenicity studies in both rat and mouse. Based on a review of 
this information by the Health Effects Division Carcinogenicity Peer 
Review Committee (CPRC) of the Office of Pesticide Programs, the Agency 
has determined that cyromazine should be reclassified to Group E-no 
evidence for carcinogenicity in humans. The consensus of the CPRC was 
that the reexamination of mammary gland tissues in the mouse and rat 
was performed in an acceptable manner and based on these revised data, 
there were no statistically significant increases in tumors in the 
treated groups, and there were no statistically significant trends. 
Therefore, the classification of cyromazine has been revised to Group E 
in accordance with Agency guidelines, published in the Federal Register 
of September 24, 1986 (51 FR 33992).
    The Agency has modified and updated its policy concerning whether 
concentration occurs in processed foods. In the past, EPA has found 
that a food additive tolerance (section 409) is necessary whenever a 
pesticide concentrates in the processed food (i.e., the levels in parts 
per million are greater in the processed food than in the raw food). 
The National Food Processors Association (NFPA) raised a number of 
concerns with the Agency's traditional approach to determining whether 
concentration occurs. EPA concluded that modifications can be made to 
its policy to ensure better predictions of concentration. Although 
information from processing studies will remain the most important 
information in determining whether concentration occurs EPA will now 
also take into account information concerning mixing and blending of 
crops information pertaining to average residues.
    As a result of this change in policy the Agency has reevaluated the 
processing data for tomato and has concluded that a food additive 
tolerance is not needed for cyromazine residues including the 
metabolite melamine in processed tomato products. Tolerances are needed 
to prevent processed foods from being deemed adulterated when the 
processed food when ready to eat contains a pesticide residue at a 
level greater than permitted by the corresponding section 408 tolerance 
21 U.S.C. 342(a)(2). In 1993, EPA had concluded that a 409 tolerance 
for processed tomato products was needed due to a processing study

[[Page 19844]]

that showed levels of cyromazine in tomato paste (the tomato byproduct 
with the highest concentration) 2.2 times the level in tomato (i.e., a 
concentration factor 2.2X). However, other processing studies showed 
that processing tomato paste resulted in a reduction of cyromazine 
residues or a lower concentration factor than 2.2X. In accordance with 
the Agency's revised concentration policy when the results from all 
processing studies for tomato paste were averaged, the concentration 
factor was lowered to 1X. Given the variability in analytical methods 
and this lower concentration factor, EPA believes that it is unlikely 
that any tomato paste or other processed tomato products derived from 
tomatoes containing legal levels of cyromazine could be reliably 
determined to have levels of cyromazine above the tomato tolerance. 
Because it is unlikely that processed tomato products will have levels 
of cyromazine above the section 408 tolerance, no section 409 tolerance 
is needed. In a letter dated November 21, 1995 Ciba requested 
withdrawal of the food additive proposal in processed tomato products.
    In the same November 21, 1995 letter Ciba also requested withdrawal 
of the feed additive proposal in or on tomato pomaces; withdrawal of 
tolerance for cyromazine and melamine in milk, meat, fat and meat 
byproducts of cattle, goats, hogs, horses and sheep; withdrawal of the 
tolerance for the metabolite, 1-methycyromazine in the liver and kidney 
of cattle, goats, hogs, horses and sheep and withdrawal of the request 
to remove the restriction ``from chicken layer and breeder hens only''. 
Ciba's withdrawal of these tolerances were submitted in response to 
EPA's latest revision (unpublished) to Table II (September 1995) of the 
Pesticide Assessment Guidelines, Subdivision O (Residue Chemistry) 
titled Raw Agricultural and Processed Commodities and Livestock Feeds 
Derived from Field Crops and Ciba's voluntary withdrawal of a companion 
proposed tolerance request for use of cyromazine and its metabolite 
melamine in or on carrot (PP 6F3329)(See 60 FR 54689, October 25, 
1995). With respect to the feed additive proposal for tomato pomace EPA 
has concluded that tomato pomaces (wet and dry) are no longer 
considered feedstuffs. Withdrawal of the proposed use of cyromazine on 
carrot eliminated potential residues from the feedstuff carrot culls. 
Thus based upon the decision that tomato pomaces are no longer 
feedstuffs and withdrawal of the carrot tolerance (carrot culls), feed 
additive tolerances in animal commodities are not necessary for this 
proposed use.
    An adequate analytical method, AG-584A, is available for 
enforcement purposes.
    There are presently no actions pending against the continued 
registration of this chemical. The pesticide is considered useful for 
the purpose for which the tolerance is sought.
    Based on the information and data considered, the Agency has 
determined that the tolerance established by amending 40 CFR part 180 
will protect the public health. Therefore, the tolerance is established 
as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed 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 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).
    A record has been established for this rulemaking under the docket 
number [PP 6F3333 and FAP2H5640/R2234] (including any comments and data 
submitted electronically). A public version of this record, including 
printed, paper versions of electronic comments, which does not include 
any information claimed as CBI, is available for inspection from 8 a.m. 
to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
public record is located in Room 1132 of the Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rule-making record 
which will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 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. In addition, this action does not impose any enforceable 
duty, or contain any ``unfunded mandates'' as described in Title II of 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require 
prior consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, 1993), entitled Enhancing the Intergovernmental 
Partnership, or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-

[[Page 19845]]

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: April 18, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is 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 the table in paragraph (e) is amended by adding 
alphabetically the following raw agricultural commodity:


Sec. 180.414  Cyromazine; tolerances for residues.

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                                                              Parts per 
                         Commodity                             million  
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                  *        *        *        *        *                 
Tomato.....................................................          1.0
                                                                        
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[FR Doc. 96-10922 Filed 5-2-96; 8:45 am]
BILLING CODE 6560-50-F