[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Rules and Regulations]
[Pages 44492-44496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15334]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0068; FRL-7728-5]


Inert ingredients; Revocation of Pesticide Tolerance Exemptions 
for Three CFC Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking exemptions from the requirement of a tolerance 
for three inert ingredients (dichlorodifluoromethane, 
dichlorotetrafluoroethane, and trichlorofluoromethane) because these 
substances no longer have active Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) pesticide product registrations and/or because 
their use in pesticide products sold in the United States (U.S.) has 
been prohibited under the Clean Air Act (CAA) for over a decade due to 
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. The 
regulatory actions in this document contribute toward the Agency's 
tolerance reassessment requirements of the Federal Food, Drug, and 
Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality

[[Page 44493]]

Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 
to reassess the tolerances in existence on August 2, 1996. The 
regulatory actions in this document pertain to the revocation of five 
tolerance exemptions of which five count as tolerance reassessments 
toward the August, 2006 review deadline.

DATES: This regulation is effective August 3, 2005. Objections and 
requests for hearings must be received on or before October 3, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit IV. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0068. 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: [email protected].

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

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of April 27, 2005 (70 FR 21713) (FRL-7709-
1), EPA issued a proposed rule to revoke five tolerance exemptions for 
residues of dichlorodifluoromethane, dichlorotetrafluoroethane, and 
trichlorofluoromethane because those substances are either no longer 
contained in pesticide products and/or because their use in pesticide 
products sold in the U.S. has been prohibited for over a decade due to 
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. 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 CAA, on certain non-essential aerosol and pressurized products 
containing ozone depleting compounds (see 40 CFR part 82, subpart C). 
Also the proposal of April 27, 2005 (70 FR 21713) provided a 60-day 
comment period that invited public comment for consideration and for 
support of tolerance exemption retention under the FFDCA standards.
    In this final rule, EPA is revoking five tolerance exemptions for 
residues of dichlorodifluoromethane, dichlorotetrafluoroethane, and 
trichlorofluoromethane because these specific tolerance exemptions 
correspond to uses no longer current or registered under FIFRA in the 
United States. The tolerance exemptions revoked by this final rule are 
no longer necessary to cover residues of the relevant pesticide 
chemicals in or on domestically treated commodities or commodities 
treated outside but imported into the United States. It is EPA's 
general practice to revoke those tolerances and tolerance exemptions 
for residues of pesticide chemicals on crop uses for which there are no 
active registrations under FIFRA, unless any person commenting on the 
proposal indicates a need for the tolerance or tolerance exemption to 
cover residues in or on imported commodities or domestic commodities 
legally treated.
    EPA has historically been concerned that retention of tolerances 
and tolerance exemptions that are not necessary to cover residues in or 
on legally treated foods may encourage misuse of pesticides within the 
United States. Thus, it is EPA's policy to issue a final rule revoking 
those tolerances and tolerance exemptions for residues of pesticide 
chemicals for which there are no active registrations or uses under 
FIFRA, unless any person commenting on the proposal demonstrates a need 
for the tolerance to cover residues in or on imported commodities or 
domestic commodities legally treated.
    Generally, EPA will proceed with the revocation of these tolerances 
and tolerance exemptions on the grounds discussed in Unit II.A. if one 
of the following conditions applies:
    1. Prior to EPA's issuance of a section 408(f) order requesting 
additional data or issuance of a section 408(d) or (e) order revoking 
the tolerances or tolerance exemptions on other grounds, commenters 
retract the comment identifying a need for the tolerance to be 
retained.
    2. EPA independently verifies that the tolerance or tolerance 
exemption is no longer needed.
    3. The tolerance or tolerance exemption is not supported by data 
that demonstrate that the tolerance or tolerance exemption meets the 
requirements under FQPA.
    EPA received one comment on the proposal to revoke these tolerance 
exemptions, and the commenter supported this revocation action.
    Therefore, for the reasons stated herein and in the proposed rule, 
EPA is revoking the exemptions from the requirement of a tolerance in 
40 CFR 180.910 for residues of dichlorodifluoromethane, 
dichlorotetrafluoroethane, and trichlorofluoromethane, and in 40 CFR 
180.930 for residues of dichlorodifluoromethane and 
trichlorofluoromethane.

[[Page 44494]]

B. What is the Agency's Authority for Taking this Action?

    This final 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)).
    EPA's general practice is to revoke tolerances and tolerance 
exemptions for residues of pesticide chemicals on crops for which FIFRA 
registrations no longer exist and on which the pesticide may therefore 
no longer be used in the United States. EPA has historically been 
concerned that retention of tolerances and tolerance exemptions that 
are not necessary to cover residues in or on legally treated foods may 
encourage misuse of pesticides within the United States. Nonetheless, 
EPA will establish and maintain tolerances and tolerance exemptions 
even when corresponding domestic uses are canceled if the tolerances, 
which EPA refers to as ``import tolerances,'' are necessary to allow 
importation into the United States of food containing such pesticide 
residues. However, where there are no imported commodities that require 
these import tolerances, the Agency believes it is appropriate to 
revoke tolerances and tolerance exemptions for unregistered pesticide 
chemicals in order to prevent potential misuse.

C. When Do These Actions Become Effective?

    These actions become effective on the date of publication of this 
final rule in the Federal Register. Any commodities listed in the 
regulatory text of this document that are treated with the pesticide 
chemicals subject to this final rule, and that are in the channels of 
trade following the tolerance exemption revocations, shall be subject 
to FFDCA section 408(1)(5), as established by the FQPA. Under this 
section, any residues of these pesticide chemicals in or on such food 
shall not render the food adulterated so long as it is shown to the 
satisfaction of the Food and Drug Administration that: (1) The residue 
is present as the result of an application or use of the pesticide 
chemical at a time and in a manner that was lawful under FIFRA, and (2) 
the residue does not exceed the level that was authorized at the time 
of the application or use to be present on the food under an exemption 
from tolerance. Evidence to show that food was lawfully treated may 
include records that verify the dates that the pesticide chemical was 
applied to such food.

III. Are There Any International Trade Issues Raised by this Final 
Action?

    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain in a Federal Register document the 
reasons for departing from the Codex level. EPA's effort to harmonize 
with Codex MRLs is summarized in the tolerance reassessment section of 
individual Reregistration Eligibility Decision Documents (REDs). The 
EPA has developed guidance concerning submissions for import tolerance 
support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be 
made available to interested persons. Electronic copies are available 
on the internet at http://www.epa.gov/. On the Home Page select ``Laws 
and Regulations,'' then select ``Regulations and Proposed Rules'' and 
then look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the ``Federal 
Register'' listings at  http://www.epa.gov/fedrgstr/.

IV. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
''object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0068 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 October 
3, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IV.A.1., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your

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copies, identified by docket ID number OPP-2005-0068, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

V. Statutory and Executive Order Reviews

    In this final rule, EPA revokes specific tolerance exemptions 
established under FFDCA section 408. EPA establishes tolerances under 
FFDCA section 408(e), and also modifies and revokes specific tolerances 
established under FFDCA section 408. The Office of Management and 
Budget (OMB) has exempted this type of action (i.e., a tolerance 
revocation for which extraordinary circumstances do not exist) 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 due to its lack of 
significance, 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). 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., 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 as required by 
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 other 
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 consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-13, 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 exemptions from 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 pesticide 
chemicals listed in this rule, the Agency hereby certifies that this 
final rule 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 
chemicals named in this final rule, the Agency knows of no 
extraordinary circumstances that exist as to the present revocations 
that would change EPA's previous analysis. 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 final 
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 FFDCA. 
For these same reasons, the Agency has determined that this 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 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 rule.

VI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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

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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: July 27, 2005.

Donald R. Stubbs,
Acting 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.


Sec.  180.910  [Amended]

0
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]

0
3. Section 180.930 is amended by removing the following exemptions and 
any associated Limits and Uses from the table: Dichlorodifluoromethane 
and Trichlorofluoromethane.

[FR Doc. 05-15334 Filed 8-2-05; 8:45 am]
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