[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Rules and Regulations]
[Pages 10543-10545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5409]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300620; FRL-5772-8]
RIN 2070-AB78


Myclobutanil; Extension of Tolerance 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 in or on strawberries at 0.5 part per million 
(ppm) for an additional 1-year period, to March 31, 1999. This action 
is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on strawberries. Section 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (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.

DATES: This regulation becomes effective March 4, 1998. Objections and 
requests for hearings must be received by EPA, on or before May 4, 
1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300620], 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-300620], 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. 119, 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: Stephen Schaible, 
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. 267, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9362; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of April 11, 1997 (62 FR 17730) (FRL-5597-9), which 
announced that on its own initiative and under section 408(e) of the 
FFDCA, 21 U.S.C. 346a(e) and (l)(6), it established a time-limited 
tolerance for the residues of myclobutanil and its

[[Page 10544]]

metabolite in or on strawberries at 0.5 ppm, with an expiration date of 
March 31, 1998. 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 received a request to extend the use of myclobutanil on 
strawberries for this year's growing season due to continued incidence 
of powdery mildew in Florida and the claimed ineffectiveness of 
registered alternatives at controlling the disease. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this State. EPA has authorized under FIFRA section 18 the use of 
myclobutanil on strawberries for control of powdery mildew in 
strawberries.
     EPA assessed the potential risks presented by residues of 
myclobutanil in or on strawberries. In doing so, EPA considered the new 
safety standard in FFDCA section 408(b)(2), and decided that the 
necessary tolerance under FFDCA section 408(l)(6) would be consistent 
with the new safety standard and with FIFRA section 18. The data and 
other relevant material have been evaluated and discussed in the final 
rule of April 11, 1997 (62 FR 17730). Based on that data and 
information considered, the Agency reaffirms that extension of the 
time-limited tolerance will continue to meet the requirements of 
section 408(l)(6). Therefore, the time-limited tolerance is extended 
for an additional 1-year period. Although this tolerance will expire 
and is revoked on March 31, 1999, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on strawberries 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 FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. 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 May 4, 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-300620]. 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 that was 
previously extended by EPA 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). In addition, 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).
    Since this extension of an existing time-limited tolerance does not 
require the issuance of a proposed rule, the

[[Page 10545]]

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 Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule 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.

    Dated: February 18, 1998.

James Jones,
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 ``Strawberries'' by removing ``March 31, 1998'' and by adding 
in its place ``3/31/99''.

[FR Doc. 98-5409 Filed 3-3-98; 8:45 am]
BILLING CODE 6560-50-F