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Pesticide Tolerances for Myclobutanil

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [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 (alphabutyl
-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

 
 

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