[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: opp-docket@epamail.epa.gov.
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:
glarocca@epamail.epa.gov
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
