[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Rules and Regulations]
[Pages 71670-71673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33158]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300957; FRL-6398-2]
RIN 2070-AB78


Myclobutanil; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends a time-limited tolerance for combined 
residues of the fungicide myclobutanil and its metabolites in or on 
hops at 5.0 parts per million (ppm) for an additional 2-year period. 
This tolerance will expire and is revoked on December 31, 2001. This 
regulation also extends time-limited tolerances for combined residues 
of the fungicide myclobutanil and its metabolites, in or on caneberries 
at 1.0 ppm and in or on peppermint and spearmint at 2.5 ppm for an 
additional 1-year period. These tolerances will expire and are revoked 
on December 31, 2000. This action is in response to EPA's granting of 
emergency exemptions under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on caneberries, hops, peppermint and spearmint. 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 is effective December 22, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300957, 
must be received by EPA on or before February 22, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit III. of the ``SUPPLEMENTARY 
INFORMATION.'' To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300957 in the 
subject line on the first page of your response.

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; telephone 
number: (703) 308-9358; and e-mail address: Deegan.D[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            Potentially
                                                       Affected Entities
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Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------



[[Page 71671]]

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under ``FOR FURTHER INFORMATION 
CONTACT.''

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300957. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2 (CM #2), 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA a final rule, published in the Federal Register of July 10, 
1998 (63 FR 37289) (FRL-5798-6), which announced that on its own 
initiative under section 408 of FFDCA, 21 U.S.C. 346a, as amended by 
the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it 
established a time-limited tolerance for the combined residues of 
myclobutanil and its metabolites in or on hops at 5.0 ppm, and 
caneberries at 1.0 ppm with an expiration date of December 31, 1999. In 
the Federal Register of July 17, 1998 (63 FR 38481) (FRL-6016-8), a 
time-limited tolerance for myclobutanil and its metabolites was 
established in or on peppermint and spearmint at 2.5 ppm, with an 
expiration date of January 31, 2000. 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 requests to extend the use of myclobutanil on hops, 
caneberries, and mint for this year's growing season, due to the 
ongoing difficulties of controlling powdery mildew on hops and mint, 
peppermint rust on mint, and of orange rust on caneberries. EPA's 
review of these exemption requests have concluded that there are no 
other readily-available means to effectively control these pest 
situations at the current time. After reviewing each of these 
submissions, EPA concurs that emergency conditions existed, and EPA 
authorized the requested uses of myclobutanil under provisions of FIFRA 
section 18.
    EPA's assessed the potential risks presented by residues of 
myclobutanil in or on caneberries, hops, and mint. In doing so, EPA 
considered the 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 safety standard and with FIFRA section 18. The data 
and other relevant material have been evaluated and discussed in the 
final rule published in the Federal Register of July 10, 1998 (63 FR 
37289). Based on that data and information considered, the Agency 
reaffirms that extension of the time-limited tolerances will continue 
to meet the requirements of section 408(l)(6). Therefore, the time-
limited tolerances are extended for an additional 1 or 2-year period. 
EPA will publish a document in the Federal Register to remove the 
revoked tolerances from the Code of Federal Regulations (CFR). Although 
these tolerances will expire and are revoked on December 31, 2000, or 
December 31, 2001, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on the commodites after the expiration 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 these tolerances earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.

III. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300957 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before February 
22, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(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). 
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

[[Page 71672]]

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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit III.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-300957, 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 or 
by courier, bring a copy to the location of the PIRIB described in Unit 
I.B.2. You may also send an electronic copy of your request via e-mail 
to: [email protected]. Please use an ASCII file format and avoid the 
use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not 
include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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).

IV. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408 in response to a FIFRA section 18 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) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); 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 or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 petition under FFDCA section 408, 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

V. Submission to Congress and the General Accounting Office

    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 this final rule in the Federal Register. This final

[[Page 71673]]

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: December 8, 1999.

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. 321(q), 346(a) and 371.

    2. In Sec. 180.443, by amending the table in paragraph (b), by 
revising the following entries to read as follows:


Sec. 180.443  Myclobutanil; tolerances for residues.

*    *    *    *    *    
    (b)    *    *    *    

 
------------------------------------------------------------------------
                                                     Parts   Expiration/
                    Commodity                         per     revocation
                                                    million      date
------------------------------------------------------------------------
 
                        *    *    *    *    *
Caneberries......................................   1.0         12/31/00
                        *    *    *    *    *
Hop cones, dried.................................   5.0         12/31/01
                        *    *    *    *    *
Peppermint.......................................   2.5         12/31/00
                        *    *    *    *    *
Spearmint........................................   2.5         12/31/00
                        *    *    *    *    *
------------------------------------------------------------------------

*    *    *    *    *    

[FR Doc. 99-33158 Filed 12-21-99; 8:45 am]
BILLING CODE 6560-50-F