Document ID: EPA-HQ-OPP-2007-0182-0005
Agency: epa
Document Type: Rule
Title: Dibasic Esters (DBE); Exemption from the Requirement of a Tolerance
Posted Date: 2008-02-27T05:00Z

[Federal Register: February 27, 2008 (Volume 73, Number 39)]
[Rules and Regulations]               
[Page 10396-10398]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe08-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0182; FRL-8341-4]

 
Dibasic Esters (DBE); Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of dibasic esters (DBE; CAS Reg. No. 95481-62-
2) when used as an inert ingredient solvent and/or anti-freeze 
microencapsulated at 10% weight/weight (W/W) or less in pesticide 
formulations with the active ingredient cyfluthrin. Whitmire Micro-Gen 
Research Laboratories, Inc. submitted a pesticide petition 5E4442 to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting 
exemptions from the requirement of a tolerance. EPA published in the 
Federal Register on August 29, 2007 (72 FR 49689) a proposed rule for 
this petition in order to provide the public with an opportunity to 
comment on data that submitted to the Agency after the publication of 
the petition's Notice of Filing.

DATES: This regulation is effective February 27, 2008. Objections and 
requests for hearings must be received on or before April 28, 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-2007-0182. 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 web site 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 either 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: Tracy Ward, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9361; e-mail address: ward.tracyh@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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 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 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 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 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. 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-2007-0182 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 April 28, 2008.

[[Page 10397]]

    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2007-0182, 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 and Statutory Findings

    In the Federal Register of December 23, 1998 (63 FR 71126) (FRL-
6047-7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP 5E4442) 
by Whitmire Micro-Gen Research Laboratories, Inc., 3568 Tree Court 
Industrial Blvd., St. Louis, MO 63122-6682. The petition requested that 
40 CFR 180.910 and 180.930 be amended by establishing an exemption from 
the requirement of a tolerance for residues of dibasic esters (DBE). 
EPA received a significant number of new studies as a result of an 
enforceable consent agreement issued under Section 4 of the Toxic 
Substance Control Act (TSCA) (Federal Register, August 5, 1999, 64 FR 
42692) (FRL-6090-6). EPA published in the Federal Register on August 
29, 2007 (72 FR 49689) (FRL-8143-3) a proposed rule for this petition 
in order to provide the public with an opportunity to comment on the 
new data.

III. EPA's Determination on Proposed Rule

    One comment was received on the proposed rule. The commenter 
expressed a general concern over test results: ``The test results show 
a real tendency to harm i do not think this product should ever be sold 
or manufactured ever.'' The Agency has addressed the results of the 
studies in the proposed rule and its decision document. The full 
decision document for this action is available on EPA's Electronic 
Docket at http://www.regulations.gov/ under docket number EPA-HQ-OPP-
2007-0182. Given the non-specificity of the comment EPA cannot respond 
further.
    Accordingly, based on the reasons set forth in the proposed rule 
and the decision document, EPA concludes that there is a reasonable 
certainty of no harm to the general population, including infants and 
children, from aggregate exposure to residues of dibasic esters (DBE; 
CAS Reg. No. 95481-62-2) when used as an inert ingredient in pesticide 
formulations. Accordingly, EPA finds that the tolerance exemptions 
described in Unit II. for residues of dibasic esters will be safe.
    The Agency is granting the requested exemptions from the 
requirement of a tolerance for residues of dibasic esters when used as 
an inert ingredient solvent and/or anti-freeze microencapsulated at 10% 
weight/weight (W/W) or less in pesticide formulations with the active 
ingredient cyfluthrin.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA in response to a 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). 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 and Safety Risks (62 FR 19885, 
April 23, 1997). 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., 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).
    Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency hereby certifies that this proposed action will not 
have significant negative economic impact on a substantial number of 
small entities. Establishing a pesticide tolerance or an exemption from 
the requirement of a pesticide tolerance is, in effect, the removal of 
a regulatory restriction on pesticide residues in food and thus such an 
action will not have any negative economic impact on any entities, 
including small entities. This final 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 
(65 FR 67249, November 6, 2000) do not apply to this rule. In addition, 
This rule does not 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).
    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).

[[Page 10398]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, 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 180.1277 is added to subpart D to read as follows:

Sec.  180.1277  Dibasic esters; exemption from the requirement of a 
tolerance.

    Dibasic esters (CAS Reg. No. 95481-62-2) is exempted from the 
requirement of a tolerance for residues when used as an inert 
ingredient (solvent and/or anti-freeze) at 10% W/W or less in 
microencapsulated pesticide formulations with the active ingredient 
cyfluthrin.
[FR Doc. E8-3492 Filed 2-26-08; 8:45 am]

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