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EPA ID: [EPA-HQ-OPP-2007-0546; FRL-8347-7]
SUBJECT CATEGORY: Thiabendazole; Threshold of Regulation Determination
DOCUMENT 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 nondetectable and below the level of regulatory concern.
SUMMARY: Thiabendazole; Threshold of Regulation Determination,
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:
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.
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 eCFR
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 EPAHQOPP20070546 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 EPAHQOPP20070546, by one of the following methods:
In the Federal Register of October 3, 2007 (72 FR 56325) (FRL8151 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(4thiazolyl)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 nondetectable 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 60day public comment period. There were no comments received in response to the proposed rule.
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 207555350; telephone number: (410) 3052905; email 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 LowIncome 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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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 104113, section 12(d) (15 U.S.C. 272 note).
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).
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.
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.
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.
CAS Reg.
Pesticide Chemical No. Use/Limits Analytical Method
Thiabendazole............................ 148798 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.
\1\Available from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade,
MD 207555350; telephone number: (410) 3052905; email address: residuemethods@epa.gov [FR Doc. E8267 Filed 11008; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3055218; email address: stanton.susan@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 26 CFR Part 1 50 CFR Part 679 40 CFR Part 180 47 CFR Part 73 33 CFR Part 117 50 CFR Part 17 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 26 CFR Part 301 50 CFR Part 622 39 CFR Part 111 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 40 CFR Part 300 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522 50 CFR Part 665 47 CFR Part 76 27 CFR Part 9