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http://www.epa.gov/fedrgstr/EPA-PEST/2005/April/Day-27/p8186.htm

Inert Ingredients; Proposal to Revoke Pesticide Tolerance Exemptions for Three CFC Chemicals
[Federal Register: April 27, 2005 (Volume 70, Number 80)]
[Proposed Rules]
[Page 21713-21715]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap05-43]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0068; FRL-7709-1]

Inert Ingredients; Proposal to Revoke Pesticide Tolerance
Exemptions for Three CFC Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke exemptions from the requirement of
a tolerance for three inert ingredients (dichlorodifluoromethane,
dichlorotetrafluoroethane, and trichlorofluoromethane) because these
substances are no longer in active Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) pesticide product registrations and/or their
use in pesticide products sold in the U.S. has been prohibited under
the Clean Air Act for over a decade by EPA's ban on the sale or
distribution, or offer for sale or distribution in interstate commerce
of certain nonessential products that contain or are manufactured with
ozone depleting compounds. These ingredients are subject to
reassessment by August, 2006 under section 408(q) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA). Upon the issuance of the final rule
revoking the tolerance exemptions, five tolerances will be counted as
``reassessed'' for purposes of FFDCA's section 408(q).

DATES: Comments must be received on or before June 27, 2005.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number OPP-2005-0068, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/ .
Follow the on-line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. EDOCKET, EPA's
electronic public docket and comment system, is EPA's preferred method
for receiving comments. Follow the on-line instructions for submitting
comments.
E-mail: Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2005-0068.
Mail: Public Information and Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001,
Attention: Docket ID Number OPP-2005-0068.
Hand Delivery: Public Information and Records Integrity Branch
(PIRIB), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington,
VA, Attention: Docket ID Number OPP-2005-0068. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number OPP-2005-
0068. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).

Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., 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 electronically in EDOCKET or in hard
copy at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.karen@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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR

[[Page 21714]]

Beta Site Two at http://www.gpoaccess.gov/ecfr/.

C. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date, and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background and Statutory Findings

This proposed rule is issued pursuant to section 408(d) of FFDCA
(21 U.S.C. 346a(d)). Section 408 of FFDCA authorizes the establishment
of tolerances, exemptions from the requirement of a tolerance,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or tolerance exemption, food
containing pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of the FFDCA. If food containing
pesticide residues is found to be adulterated, the food may not be
distributed in interstate commerce (21 U.S.C. 331(a) and 342 (a)).

III. What Action Is the Agency Taking?

EPA, acting on its own initiative, is proposing to revoke five
exemptions from the requirement of a tolerance for three inert
ingredients because those substances are either no longer contained in
pesticide products and/or their use in pesticide products sold in the
U.S. has been prohibited for over a decade by EPA's ban on the sale or
distribution, or offer for sale or distribution in interstate commerce
of certain nonessential products that contain or are manufactured with
ozone depleting compounds.

It is EPA's general practice to revoke those tolerances and
tolerance exemptions for pesticide chemical residues (which includes
both active and inert ingredients) for which there are no active
registered uses under FIFRA, or for which there are no registered
products to which the tolerance or tolerance exemption applies, or for
tolerances or tolerance exemptions that have been superseded, unless a
person commenting on the proposal indicates a need for the tolerance or
exemption to cover residues in or on imported commodities or legally
treated domestic commodities.

EPA believes this rationale also extends to ingredients whose use
in pesticide products is prohibited as a result of EPA's 1994 ban,
under the Clean Air Act, on certain non-essential aerosol and
pressurized products containing ozone depleting compounds (see 40 CFR
part 82, subpart C). Accordingly, while EPA records indicate that one
of the ingredients subject to this notice, dichlorodifluoromethane, is
still listed as an ingredient in a registered pesticide, EPA believes
it is appropriate to propose the revocation of the tolerance exemption
associated with this ingredient at this time because no product
containing this ingredient may lawfully be sold or distributed in the
U.S. Given that production and sale of such products was prohibited by
the non-essential product ban since 1994, the Agency does not expect
that there would be existing stocks in the hands of users. In the
absence of lawful sale and distribution and the unlikelihood of
existing stocks, EPA does not expect there to be residues resulting
from application of a pesticide containing any of these ingredients,
and any tolerance exemptions would therefore be superfluous.

Listed below are the three inert ingredients and their associated
five tolerance exemptions that are subject to this notice. EPA is
proposing that the revocation of these five tolerance exemptions will
become effective on the date of the final rule's publication in the
Federal Register.

1. Dichlorodifluoromethane, (40 CFR 180.910 and 930).
2. Dichlorotetrafluoroethane, (40 CFR 180.910).
3. Trichlorofluoromethane, (40 CFR 180.910 and 930).

These ingredients are currently subject to reassessment under
section 408(q) of the FFDCA. Reassessment activities for such
ingredients must be completed by August, 2006. Upon the issuance of the
final rule revoking the tolerance exemptions, five tolerances will be
counted as ``reassessed'' for purposes of FFDCA's section 408(q).

IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to revoke specific
tolerance exemptions established under section 408(d) 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). Because this
proposed rule has been exempted from review under Executive Order 12866
due to its lack of significance, this proposed 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). This proposed 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 under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary

[[Page 21715]]

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). Pursuant to the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously
assessed whether revocations of tolerances might significantly impact a
substantial number of small entities and concluded that, as a general
matter, these actions do not impose a significant economic impact on a
substantial number of small entities. This analysis was published on
December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel
for Advocacy of the Small Business Administration. Taking into account
this analysis, and available information concerning the pesticides
listed in this rule, the Agency hereby certifies that this proposed
action will not have a significant economic impact on a substantial
number of small entities. Specifically, as per the 1997 notice, EPA has
reviewed its available data on imports and foreign pesticide usage and
concludes that there is a reasonable international supply of food not
treated with canceled pesticides. Furthermore, for the pesticide named
in this proposed rule, the Agency knows of no extraordinary
circumstances that exist as to the present proposal that would change
the EPA's previous analysis. Any comments about the Agency's
determination should be submitted to the EPA along with comments on the
proposal, and will be addressed prior to issuing a final rule. In
addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 14, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR part 180 be 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. 180.910 [Amended]
2. Section 180.910 is amended by removing the following exemptions
and any associated Limits and Uses from the table:
Dichlorodifluoromethane, Dichlorotetrafluoroethane, and
Trichlorofluoromethane.
Sec. 180.930 [Amended]
3. Section 180.930 is amended by removing the following exemptions
and any associated Limits and Uses from the table:
Dichlorodifluoromethane andTrichlorofluoromethane.

[FR Doc. 05-8186 Filed 4-26-05; 8:45 am]
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