[Federal Register: January 11, 2008 (Volume 73, Number 8)]
[Rules and Regulations]
[Page 1976-1978]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja08-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0546; FRL-8347-7]
Thiabendazole; Threshold of Regulation Determination
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes by rule that there is no need for
a tolerance or tolerance exemption under the Federal Food Drug and
Cosmetic Act (FFDCA) for the use of the fungicide thiabendazole as a
seed treatment on dry peas. This determination is based on EPA's
finding that any residues that remain in food from this use will be
both non-detectable and below the level of regulatory concern.
DATES: This regulation is effective January 11, 2008. Objections and
requests for hearings must be received on or before March 11, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0546. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of
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this action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0546 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 as required by 40 CFR part 178 on or
before March 11, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0546, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background
In the Federal Register of October 3, 2007 (72 FR 56325) (FRL-8151-
6), EPA issued a proposed rule pursuant to sections 408(e) and 701(a)
of the Federal Food, Drug, and Cosmetic Act (FFDCA). The proposed rule
explained the Agency's determination that the use of the fungicide
thiabendazole [2-(4-thiazolyl)benzimidazole] as a seed treatment on dry
peas does not need an FFDCA tolerance or tolerance exemption based on
EPA's finding that any residues that remain in food from this use will
be both non-detectable and below the level of regulatory concern. The
proposed rule included a discussion of the Agency's threshold of
regulation (TOR) policy and identified the information (including
toxicity data, residue data and the analytical method) that EPA relied
on in making this TOR determination; it also established a 60-day
public comment period. There were no comments received in response to
the proposed rule.
III. Action on the Proposed Regulation
Based upon the rationale and findings set forth in the proposed
rule, the use of thiabendazole as a seed treatment on dry peas
(including field pea, pigeon pea, chickpea or lentil) is designated as
below the threshold of regulatory concern and thus as not requiring a
tolerance or a tolerance exemption under FFDCA. The use is identified
as such under 40 CFR 180.2010 (Threshold of regulation determinations).
Designation of this use as below the level of regulatory concern
does not legalize any detectable residues of thiabendazole on food. It
does mean that, despite labeling for this use on a food or feed crop,
it may be registered under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., without obtaining a
tolerance or exemption from the requirement of a tolerance as otherwise
required by 40 CFR 152.112(g). The text of the regulation has been
clarified on this point.
Adequate analytical methodology (High Pressure Liquid
Chromatography/Fluorescence Detector (HPLC/FLD) method) is available to
detect residues of thiabendazole in/on dry peas. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
IV. Statutory and Executive Order Reviews
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, as amended by
Executive Order 13422, 72 FR 2763, January 18, 2007). Because this rule
has been exempted from review under Executive Order 12866, this rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution or Use (66 FR
28355), May 22, 2001 or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks or Safety Risks (62 FR 19885,
April 23, 1997). This rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency, for the
reasons explained in the proposed rule, certifies that this rule will
not have a significant adverse economic impact on a substantial number
of small entities because this rule does not have any adverse economic
impacts.
This rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November 6,
2000) do not apply to this rule. In addition, this rule does not impose
an enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded
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Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
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).
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 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 31, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.2010 is amended by adding text to read as follows:
Sec. 180.2010 Threshold of regulation determinations.
The following pesticide chemical uses on food or feed, or food or
feed crops, do not need a tolerance or exemption from the requirement
of a tolerance, and may be registered under the Federal Insecticide,
Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq., without obtaining
such tolerance or exemption, based on EPA's determination that the uses
are below the threshold of regulation.
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CAS Reg.
Pesticide Chemical No. Use/Limits Analytical Method
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Thiabendazole............................ 148-79-8 As a seed treatment for dry High Performance Liquid
pea (including field pea, Chromatography/Florescence
pigeon pea, chickpea or Detector method\1\;
lentil), using a maximum Modification of Ion-
application rate of 0.075 Pairing Liquid
pounds of active Chromatographic
ingredient per 100 pounds Determination of
of seed. Vines or hay Benzimidazole Fungicides
grown from treated seed in Foods, Gilvydis and
may not be fed to Walters, JAOAC, vol. 73,
livestock.. no. 5, 1990.
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\1\Available from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade,
MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov
[FR Doc. E8-267 Filed 1-10-08; 8:45 am]
BILLING CODE 6560-50-S