[Federal Register Volume 62, Number 239 (Friday, December 12, 1997)]
[Rules and Regulations]
[Pages 65367-65369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32549]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300591; FRL-5760-4]
RIN 2070-AB78


Myclobutanil; Tolerance Extension for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule extends a time-limited tolerance for residues of the 
fungicide myclobutanil and its metabolites in or on cucurbits at 0.3 
parts per million (ppm) for an additional 1-year period, to November 
30, 1998. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of the pesticide on cucurbit 
vegetables. Section 408(l)(6) of the FFDCA requires EPA to establish a 
time-limited tolerance or exemption from the requirement for a 
tolerance for pesticide chemical residues in food that will result from 
the use of a pesticide under an emergency exemption granted by EPA 
under section 18 of FIFRA.

EFFECTIVE DATE: This regulation becomes effective December 12, 1997. 
Objections and requests for hearings must be received by EPA, on or 
before February 10, 1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300447], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300591], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 1132, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Follow the instructions in 
Unit II. of this preamble. No Confidential Business Information (CBI) 
should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: By mail: David Deegan, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 280, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9358; e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of January 9, 1997 (62 FR 1284) (FRL-5579-7), which 
announced that on its own initiative and under section 408(e) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and 
(l)(6), it established a time-limited tolerance for the residues of 
myclobutanil and its metabolites in or on cucurbit vegetables at 0.3 
ppm, with an expiration date of November 30, 1997. EPA established the 
tolerance because section 408(l)(6) of the FFDCA requires EPA to 
establish a time-limited tolerance or exemption from the requirement 
for a tolerance for pesticide chemical residues in food that will 
result from the use of a pesticide under an emergency exemption granted 
by EPA under section 18 of FIFRA. Such tolerances can be established 
without providing notice or period for public comment.
    EPA established the initial tolerance in response to a section 18 
authorization granted to the state of California for use of 
myclobutanil on cucurbit vegetables in July 1996. EPA granted this use 
to California consistent with provisions of section 18 of FIFRA, after 
finding that there was an emergency condition in the state requiring 
use of this product. When EPA established the time-limited tolerance it 
did so consistent with a review of available information as required 
under section 408(l)(6) of the FFDCA. EPA is taking action now to 
extend this tolerance because the Agency authorized, as allowed under 
section 18, this use to occur in the states of Arizona and Hawaii to 
control powdery mildew on cucurbit vegetables (Arizona) and limited to 
watermelons (Hawaii). This authorization occurred on May 8, 1997, and 
allowed use of the product for one year.
    EPA assessed the potential risks presented by residues of 
myclobutanil in or on cucurbit vegetables. In doing so, EPA considered 
the new safety standard in FFDCA section 408(b)(2) of the FFDCA, and 
decided that the necessary tolerance under FFDCA section 408(l)(6) of 
the FFDCA would be consistent with the new safety standard and with 
section 18 of FIFRA. The data and other relevant material have been 
evaluated and discussed in the final rule published in the Federal 
Register of January 9, 1997. Based on that data and information 
considered, the Agency reaffirms that extension of the time-limited 
tolerance will continue to meet

[[Page 65368]]

the requirements of section 408(l)(6) of the FFDCA. Therefore, the 
time-limited tolerance is extended for an additional 1-year period. 
Although this tolerance will expire and is revoked on November 30, 
1998, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on cucurbit vegetables after that date will not be unlawful, provided 
the pesticide is applied in a manner that was lawful under FIFRA and 
the application occurred prior to the revocation of the tolerance. EPA 
will take action to revoke this tolerance earlier if any experience 
with, scientific data on, or other relevant information on this 
pesticide indicate that the residues are not safe.

I. Objections and Hearing Requests

     The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a tolerance regulation issued by 
EPA under new section 408(e) and (l)(6) of the FFDCA as was provided in 
the old section 408 and in section 409 of the FFDCA. However, the 
period for filing objections is 60 days, rather than 30 days. EPA 
currently has procedural regulations which govern the submission of 
objections and hearing requests. These regulations will require some 
modification to reflect the new law. However, until those modifications 
can be made, EPA will continue to use those procedural regulations with 
appropriate adjustments to reflect the new law.
    Any person may, by February 10, 1998, file written objections to 
any aspect of this 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 issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (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 in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the information that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice.

II. Public Record and Electronic Submissions

    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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.
    Electronic comments may be sent directly to EPA at:
[email protected].


    Electronic objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Objections and hearing requests will also be accepted on 
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of 
objections and hearing requests in electronic form must be identified 
by the docket control number [OPP-300591]. No CBI should be submitted 
through e-mail. Electronic copies of objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries.

III. Regulatory Assessment Requirements

    This final rule extends a time-limited tolerance under FFDCA 
section 408(d) in response to a petition submitted to the Agency. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). This final rule 
does not contain any information collections subject to OMB approval 
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408 (d), 
such as the tolerance in this final rule, do not require the issuance 
of a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

IV. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


[[Page 65369]]


    Dated: November 25, 1997.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I 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.

Sec. 180.443  [Amended]

    2. In Sec. 180.443, by amending paragraph (b) in the table, for the 
commodity ``cucurbit vegetables'' by removing ``November 30, 1997''and 
adding in its place ``November 30, 1998''.

[FR Doc. 97-32549 Filed 12-11-97; 8:45 am]
BILLING CODE 6560-50-F