[Federal Register Volume 59, Number 211 (Wednesday, November 2, 1994)]
[Rules and Regulations]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26796]
[[Page Unknown]]
[Federal Register: November 2, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9F3811/R2082; FRL-4916-9]
RIN 2070-AB78
Pesticide Tolerances for Myclobutanil
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document extends the time-limited tolerances for residues
of the fungicide myclobutanil and certain of its metabolites in or on
the raw agricultural commodities cherries (sweet and sour), nectarines,
and peaches until April 1, 1995. This extension will allow EPA adequate
time to evaluate studies conducted by Rohm & Haas Co. required to
support permanent tolerances for this chemical in or on these
commodities.
EFFECTIVE DATE: October 14, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 9F3811/R2082], 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 a copy of the 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.
FOR FURTHER INFORMATION CONTACT: By mail: Leonard S. Cole, Jr., Acting
Product Manager (PM) 21, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 227, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6900.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of January 9, 1990 (55 FR 779), which announced that
the Rohm & Haas Co. of Independence Mall West, Philadelphia, PA 19105,
had submitted pesticide petition (PP) 9F3811 to EPA proposing to
establish tolerances under section 408 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 346a) for the fungicide myclobutanil (alpha-
butyl-alpha-(3-hydroxybutyl)-1H-1,2,4-triazole-1-propanenitrile) and
both the free and bound forms of its metabolite alpha-(3-hydroxybutyl)-
alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile in or on
stone fruits group (except cherry) at 2.0 parts per million (ppm) and
cherry at 5.0 ppm.
Subsequently, Rohm & Haas amended the petition by deleting the
request for the stone fruit group and requesting tolerances for peaches
and nectarines at 2.0 ppm and cherries (sweet and sour) at 5.0 ppm.
Additionally, the Agency requested that Rohm & Haas amend the
petition by proposing a tolerance of 4.0 ppm in/on cherries. The
petition was amended by requesting that the tolerance for cherries be
reduced to 4.0 ppm.
In the Federal Register of February 5, 1992 (57 FR 4368), EPA
established tolerances, on an interim basis, in 40 CFR 180.443 for
residues of this chemical in or on the raw agricultural commodities
cherries (sweet and sour), nectarines, and peaches. An expiration date
of October 1, 1994, was imposed for the tolerances. The interim
tolerances were established based upon the condition that data be
submitted to the Agency to fully support permanent tolerances for these
commodities.
The conditions imposed by the establishment of the interim
tolerances were that the chronic/oncogenicity feeding studies in the
mouse and the rat be repeated. Both studies need to be repeated because
a maximum-tolerated dose (MTD) had not been achieved. However, no
preneoplastic lesions were observed in either study to suggest possible
carcinogenic activity, and myclobutanil did not induce either genotoxic
effects or chromosomal aberrations in a series of mutagenicity tests.
In addition, no strong structural activity correlation to other
carcinogens has been found. Under these circumstances, EPA concluded
that no significant carcinogenic risk was posed by these tolerances for
the timeframe involved in receiving and reviewing the repeated studies.
The Agency evaluated dietary exposure to the fungicide residues for
the commodities which have established permanent or interim tolerances.
The acceptable daily intake (ADI) based on the 2-year rat chronic
feeding study (NOEL of 2.49 mg/kg body weight/ day), using a
hundredfold uncertainty factor, was calculated to be 0.025 mg/kg bwt/
day. The theoretical maximum residue contribution (TMRC) from
previously established tolerances and interim tolerances is 0.002217
mg/kg bwt/day and utilizes 8.865 percent of the ADI.
The data submitted in support of the tolerances and other relevant
material have been reviewed. The toxicological data considered in
support of these tolerances are discussed in detail in the document
establishing the interim tolerances which was published in the Federal
Register of February 5, 1992 (57 FR 4369).
Based upon the above dietary risk estimate, the Agency believes
that an extension of the interim tolerances would not pose a
significant public health risk for the period of time indicated and
would allow the Agency sufficient time to review the final reports on
all the required data. EPA does not expect that the required data will
significantly change the above risk estimate.
On the basis of the available studies on myclobutanil, the Agency
has concluded that the human risk posed by the use of myclobutanil on
cherries, nectarines, and peaches does not raise significant concerns.
The Agency has determined that extending the tolerances will protect
the human health. Therefore, as set forth below, the tolerances are
extended to April 1, 1995. Based upon the reviews of the rat and mouse
oncogenicity studies, the Agency will determine whether establishing
permanent tolerances is appropriate.
Residues remaining in or on the above raw agricultural commodities
after expiration of these tolerances will not be considered actionable
if the pesticide is legally applied during the term, and in accordance
with, provisions of the conditional registrations.
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 issues(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 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: October 14, 1994.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I of the title 40 of the Code of Federal
Regulations is amended in part 180 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. 180.443, by amending paragraph (a) by revising the table
therein, to read as follows:
Sec. 180.443 Myclobutanil; tolerances for residues.
(a) * * *
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Parts per Expiration
Commodity million date
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Apples........................................ 0.5 None
Cherries (sweet and sour)..................... 4.0 April 1,
1995
Grapes........................................ 1.0 None
Nectarines.................................... 2.0 April 1,
1995
Peaches....................................... 2.0 April 1,
1995
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[FR Doc. 94-26796 Filed 11-1-94; 8:45 am]
BILLING CODE 6560-50-F