Document ID: EPA-HQ-OPP-2007-0546-0005
Agency: epa
Document Type: Rule
Title: Thiabendazole; Threshold of Regulation Determination
Posted Date: 2008-01-11T05:00Z

[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

[[Page 1977]]

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

[[Page 1978]]

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.

0
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]

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