[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Rules and Regulations]
[Pages 42846-42849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20318]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300895; FRL-6091-6]
RIN 2070-AB78
Sodium Chlorate; Extension of Exemption from Requirement of a
Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation extends a time-limited exemption from the
requirement of a tolerance for residues of the desiccant sodium
chlorate in or on wheat for an additional 1\1/2\-year period. This
exemption from the requirement of a tolerance will expire and is
revoked on July 31, 2001. This action is in connection with a crisis
exemption declared under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on wheat. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act
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 authorized under FIFRA section 18.
DATES: This regulation becomes effective August 6, 1999. Objections and
requests for hearings must be received by EPA, on or before October 5,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300895], 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-300895], must also be submitted to:
[[Page 42847]]
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 (CM #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: opp-docket@epa.gov. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300895].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, 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, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9364,
pemberton.libby@epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of December 3, 1997 (62 FR 63858) (FRL-5754-1), which
announced that on its own initiative under section 408 of the Federal
Food, Drug, and Cosmetic Act (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 exemption from the requirement of a
tolerance for the residues of sodium chlorate in or on wheat, with an
expiration date of July 31, 1998. EPA extended the expiration date of
this exemption to January 31, 2000 in a Federal Register notice
published July 1, 1998 (63 FR 35844) (FRL-5795-8). EPA established the
exemption from the requirement of a 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 FIFRA section 18. Such
tolerances can be established without providing notice or period for
public comment.
EPA received a request to extend the use of sodium chlorate on
wheat for this year's growing season due to the need for a harvest aid
to desiccate winter weeds which developed in thin stands of an already
diminished wheat crop.
EPA assessed the potential risks presented by residues of sodium
chlorate in or on wheat. 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 of
December 3, 1997 (62 FR 63858). Based on that data and information
considered, the Agency reaffirms that extension of the time-limited
exemption from the requirement of a tolerance will continue to meet the
requirements of section 408(l)(6). Therefore, the time-limited
exemption from the requirement of a tolerance is extended for an
additional 1\1/2\-year period. EPA will publish a document in the
Federal Register to remove the revoked tolerance from the Code of
Federal Regulations (CFR). Although this exemption from the requirement
of a tolerance will expire and is revoked on July 31, 2001, under FFDCA
section 408(l)(5), residues of the pesticide remaining in or on wheat
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 exemption from the requirement of a
tolerance. EPA will take action to revoke this exemption from the
requirement 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 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 October 5, 1999, 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 under the ``ADDRESSES'' section (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). 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 tolerance objection fee waivers,
contact James Tompkins, 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. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
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.
[[Page 42848]]
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
EPA has established a record for this regulation under docket
control number [OPP-300895] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit 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 record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
III. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes an exemption from the requirement of a
tolerance under section 408 of the FFDCA. 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 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 tolerances and exemptions that are established
under section 408(l)(6) of FFDCA, such as the exemption 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 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.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
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 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).
[[Page 42849]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 26, 1999.
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. 321(q), 346a and 371.
Sec. 180.1020 [Amended]
2. In Sec. 180.1020, by amending paragraph (b) by changing the date
``1/31/00'' to read ``7/31/01''.
[FR Doc. 99-20318 Filed 8-5-99; 8:45 am]
BILLING CODE 6560-50-F
