Document ID: EPA-HQ-OPP-2005-0322-0001
Agency: epa
Document Type: Proposed Rule
Title: Benzaldehyde, Captafol, Hexaconazole, Paraformaldehyde, Sodium dimethyldithiocarbamate, and Tetradifon; Proposed Tolerance Actions
Posted Date: 2005-12-23T14:06:41Z

[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Proposed Rules]               
[Page 76224-76228]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de05-22]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0322; FRL-7751-3]

 
Benzaldehyde, Captafol, Hexaconazole, Paraformaldehyde, Sodium 
dimethyldithiocarbamate, and Tetradifon; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke specific tolerances and tolerance 
exemptions for residues of the insecticides paraformaldehyde and 
tetradifon; fungicides captafol, hexaconazole, and sodium 
dimethyldithiocarbamate; and bee repellant benzaldehyde. EPA canceled 
food use registrations or deleted food uses from registrations 
following requests for voluntary cancellation or use deletion by the 
registrants, or non-payment of registration maintenance fees. Also, 
stakeholders have withdrawn their support for import tolerances for 
captafol and hexaconazole. EPA expects to determine whether any 
individuals or groups want to support these tolerances. The regulatory 
actions proposed in this document contribute toward the Agency's 
tolerance reassessment requirements under the Federal Food, Drug, and 
Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality 
Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 
to reassess the tolerances that were in existence on August 2, 1996. 
The regulatory actions proposed in this document pertain to the 
proposed revocation of 39 tolerances and tolerance exemptions of which 
38 would be counted as tolerance reassessments toward the August 2006 
review deadline.

DATES: Comments must be received on or before February 21, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2005-0322, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/. 

Follow the on-line instructions for submitting comments.
     Agency Web Site: EDOCKET, EPA's electronic public docket 
and comment system was replaced on November 25, 2005, by an enhanced 
federal-wide electronic docket management and comment system located at 
http://www.regulations.gov/. Follow the on-line instructions.

     E-mail: Comments may be sent by e-mail to 
opp-docket@epa.gov, Attention: Docket ID Number EPA-HQ-OPP-2005-0322.

     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 EPA-HQ-OPP-2005-0322.
     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 EPA-HQ-OPP-2005-0322. Such 
deliveries are only accepted during the Docket's normal hours of 
operation, and

[[Page 76225]]

special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0322. 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: Joseph Nevola, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8037; e-mail 
address:nevola.joseph@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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II.A. 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 athttp://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180 

is available at E-CFR Beta Site Two athttp://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.

D. What Can I do if I Wish the Agency to Maintain a Tolerance That the 
Agency Proposes to Revoke?

    This proposed rule provides a comment period of 60 days for any 
person to state an interest in retaining a tolerance proposed for 
revocation. If EPA receives a comment within the 60-day period to that 
effect, EPA will not proceed to revoke the tolerance immediately. 
However, EPA will take steps to ensure the submission of any needed 
supporting data and will issue an order in the Federal Register under 
FFDCA section 408(f) if needed. The order would specify data needed and 
the time frames for its submission, and would require that within 90 
days some person or persons notify EPA that they will submit the data. 
If the data are not submitted as required in the order, EPA will take 
appropriate action under FFDCA.

[[Page 76226]]

    EPA issues a final rule after considering comments that are 
submitted in response to this proposed rule. In addition to submitting 
comments in response to this proposal, you may also submit an objection 
at the time of the final rule. If you fail to file an objection to the 
final rule within the time period specified, you will have waived the 
right to raise any issues resolved in the final rule. After the 
specified time, issues resolved in the final rule cannot be raised 
again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to revoke certain specific tolerances and 
tolerance exemptions for residues of the insecticides paraformaldehyde 
and tetradifon; fungicides captafol, hexaconazole, and sodium 
dimethyldithiocarbamate; and bee repellant benzaldehyde because these 
specific tolerances and tolerance exemptions correspond to uses which 
are no longer current or registered under FIFRA in the United States, 
or no longer supported as import tolerances. It is EPA's general 
practice to propose revocation of those tolerances for residues of 
pesticide active ingredients on crop uses for which there are no active 
registrations under FIFRA, unless any person in comments on the 
proposal indicates a need for the tolerance to cover residues in or on 
imported commodities or domestic commodities legally treated.
    1. Benzaldehyde. The last active registration for use of 
benzaldehyde as a bee repellant in the harvesting of honey was canceled 
in 1991 due to non-payment of the maintenance fee, and therefore the 
tolerance exemption is no longer needed. EPA is proposing to revoke the 
tolerance exemption in 40 CFR 180.1229 for residues of benzaldehyde 
when used as a bee repellant in the harvesting of honey.
    2. Captafol. The Republic of Indonesia's Indonesian Ministry of 
Agriculture had commented to a proposed rule to revoke tolerances for 
captafol and several other pesticides, published in the Federal 
Register of June 9, 1993 (58 FR 32320)(FRL-4183-6). The commenter had 
stated that the use of captafol was being reevaluated in that country, 
might undergo a phase out, and requested that EPA not revoke the onion, 
potato, and tomato tolerances in 40 CFR 180.267. In the Federal 
Register of July 21, 1999 (64 FR 39049)(FRL-6092-7), EPA published a 
final rule in which it revoked specific captafol tolerances and 
responded to the 1993 comment received from the Republic of Indonesia 
by stating that the Agency would not take final action on the three 
tolerances in 40 CFR 180.267 for residues of captafol on onion, potato, 
and tomato at that time. In April 2005, EPA determined that captafol 
has not been registered in Indonesia since 1998. Also, the Indonesian 
Ministry of Agriculture verified that it no longer has a continuing 
interest in the three captafol tolerances for importation purposes. 
Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.267 
for residues of the fungicide captafol in or on onion, potato, and 
tomato.
    3. Hexaconazole. There have been no active U.S. registrations for 
hexaconazole on banana since 1992. Recently, Syngenta has informed EPA 
that it has voluntarily chosen to no longer support the hexaconazole 
tolerance on banana for the purpose of importation. Consequently, the 
tolerance is no longer needed. Therefore, EPA is proposing to revoke 
the tolerance in 40 CFR 180.488 for residues of the fungicide 
hexaconazole in or on banana.
    4. Paraformaldehyde. The last active registration for 
paraformaldehyde use as an insecticide for the soil treatment of sugar 
beets was canceled in 1989 due to non-payment of the maintenance fee, 
and therefore the tolerance exemptions are no longer needed. EPA is 
proposing to revoke the tolerance exemptions in 40 CFR 180.1024 for 
residues of the insecticide paraformaldehyde in or on beet, sugar, 
roots and beet, sugar, tops, when applied to the soil not later than 
planting.
    5. Sodium dimethyldithiocarbamate. The last active registration for 
use of sodium dimethyldithiocarbamate on melons was canceled in 1993 
due to non-payment of the maintenance fee, and therefore the tolerance 
is no longer needed. EPA is proposing to revoke the tolerance in 40 CFR 
180.152 for residues of the fungicide sodium dimethyldithiocarbamate, 
calculated as zinc ethylenebisdithiocarbamate, in or on melon.
    6. Tetradifon. The last tetradifon registrations were canceled in 
1990 due to non-payment of maintenance fees. Uniroyal Chemical Company 
(which later became part of Crompton Corporation) had commented to a 
proposed revocation of tetradifon tolerances published in the Federal 
Register of August 1, 2001 (66 FR 39705)(FRL-6786-4). Uniroyal noted 
that it had submitted certain studies to EPA in 1998 and 1996, and 
requested that EPA not revoke any of the tetradifon tolerances in 40 
CFR 180.174. In the Federal Register of January 24, 2003 (68 FR 
3425)(FRL-7187-3), EPA published a final rule and responded to 
Uniroyal's comment by stating that the Agency would not take final 
action on the tetradifon tolerances in 40 CFR 180.174 at that time. 
During follow-up communication, EPA received a letter from Crompton 
Corporation (now Chemtura Corporation) that it no longer supports 
retention of the tolerances for tetradifon. Therefore, EPA is proposing 
to revoke all the tolerances in 40 CFR 180.174 for residues of the 
insecticide tetradifon in or on apple; apricot; cherry; citron, citrus; 
crabapples; cucumber; fig; fig, dried fruit; grapefruit; grape; hop, 
dried; hop, vine; lemon; lime; meat; melon; milk; nectarine; orange, 
sweet; peach; pear; peppermint; plum, prune, fresh; pumpkin; quince; 
spearmint, tops; strawberry; tangerine; tea, dried; tomato; and winter 
squash.

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

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by the FQPA of 1996, Public Law 104-170, authorizes the 
establishment of tolerances, exemptions from tolerance requirements, 
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 exemption, food containing 
pesticide residues is considered to be unsafe and therefore 
``adulterated'' under section 402(a) of the FFDCA, 21 U.S.C. 342(a). 
Such food may not be distributed in interstate commerce (21 U.S.C. 
331(a)). For a food-use pesticide to be sold and distributed, the 
pesticide must not only have appropriate tolerances under the FFDCA, 
but also must be registered under FIFRA (7 U.S.C. 136 et seq.). Food-
use pesticides not registered in the United States must have tolerances 
in order for commodities treated with those pesticides to be imported 
into the United States.
    EPA's general practice is to propose revocation of tolerances for 
residues of pesticide active ingredients 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 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

[[Page 76227]]

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 for unregistered pesticides in order to prevent 
potential misuse.
    Furthermore, as a general matter, the Agency believes that 
retention of import tolerances not needed to cover any imported food 
may result in unnecessary restriction on trade of pesticides and foods. 
Under section 408 of the FFDCA, a tolerance may only be established or 
maintained if EPA determines that the tolerance is safe based on a 
number of factors, including an assessment of the aggregate exposure to 
the pesticide and an assessment of the cumulative effects of such 
pesticide and other substances that have a common mechanism of 
toxicity. In doing so, EPA must consider potential contributions to 
such exposure from all tolerances. If the cumulative risk is such that 
the tolerances in aggregate are not safe, then every one of these 
tolerances is potentially vulnerable to revocation. Furthermore, if 
unneeded tolerances are included in the aggregate and cumulative risk 
assessments, the estimated exposure to the pesticide would be inflated. 
Consequently, it may be more difficult for others to obtain needed 
tolerances or to register needed new uses. To avoid potential trade 
restrictions, the Agency is proposing to revoke tolerances for residues 
on crops uses for which FIFRA registrations no longer exist, unless 
someone expresses a need for such tolerances. Through this proposed 
rule, the Agency is inviting individuals who need these import 
tolerances to identify themselves and the tolerances that are needed to 
cover imported commodities.
    Parties interested in retention of the tolerances should be aware 
that additional data may be needed to support retention. These parties 
should be aware that, under FFDCA section 408(f), if the Agency 
determines that additional information is reasonably required to 
support the continuation of a tolerance, EPA may require that parties 
interested in maintaining the tolerances provide the necessary 
information. If the requisite information is not submitted, EPA may 
issue an order revoking the tolerance at issue.

C. When do These Actions Become Effective?

    EPA is proposing that revocation of these tolerances and tolerance 
exemptions become effective on the date of publication of the final 
rule in the Federal Register because their associated uses have been 
canceled for several years. The Agency believes that treated 
commodities have had sufficient time for passage through the channels 
of trade. However, if EPA is presented with information that existing 
stocks would still be available and that information is verified, the 
Agency will consider extending the expiration date of the tolerance. If 
you have comments regarding existing stocks and whether the effective 
date allows sufficient time for treated commodities to clear the 
channels of trade, please submit comments as described under 
SUPPLEMENTARY INFORMATION.
    Any commodities listed in this proposal treated with the pesticides 
subject to this proposal, and in the channels of trade following the 
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as 
established by FQPA. Under this section, any residues of these 
pesticides 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 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 a tolerance or exemption from tolerance. Evidence to 
show that food was lawfully treated may include records that verify the 
dates when the pesticide was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006 to reassess the tolerances 
in existence on August 2, 1996. As of December 8, 2005, EPA has 
reassessed over 7,820 tolerances. This document proposes to revoke a 
total of 39 tolerances and tolerance exemptions of which 38 would be 
counted as tolerance reassessments toward the August 2006 review 
deadline of FFDCA section 408(q), as amended by FQPA in 1996.

III. Are The Proposed Actions Consistent With International 
Obligations?

    The tolerance revocations in this proposal are not discriminatory 
and are designed to ensure that both domestically-produced and imported 
foods meet the food safety standard established by the FFDCA. The same 
food safety standards apply to domestically produced and imported 
foods.
    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. It is EPA's policy to 
harmonize U.S. tolerances with Codex MRLs to the extent possible, 
provided that the MRLs achieve the level of protection required under 
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual Reregistration Eligibility 
Decision documents. 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, Regulations, and Dockets,'' 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. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific 
tolerances and tolerance exemptions established under FFDCA section 
408. The Office of Management and Budget (OMB) has exempted this type 
of action (i.e., 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 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, entitled 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

[[Page 76228]]

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 104-113, 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 proposed rule, the Agency hereby certifies that this proposed 
action will not have a significant negative 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: December 13, 2005.
James Jones,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I 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. Sec.  180.152, 180.174, 180.267, 180.488, 180.1024 and 
180.1229  [Removed]

    2. Sections 180.152, 180.174, 180.267, 180.488, 180.1024 and 
180.1229 are removed.
[FR Doc. E5-7693 Filed 12-22-05; 8:45 am]

BILLING CODE 6560-50-S