Cyhexatin; Proposed Tolerance Actions, 43368-43372 [05-14738]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Proposed Rules]
[Pages 43368-43372]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14738]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0160; FRL-7723-5]


Cyhexatin; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revoke, under the Federal Food, 
Drug, and Cosmetic Act (FFDCA) section 408(e)(1), all existing 
tolerances for residues of the insecticide/acaricide cyhexatin because 
they do not meet requirements of FFDCA section 408(b)(2). EPA canceled 
food use registrations for cyhexatin in 1989. Currently, EPA determined 
that acute dietary risks from use of cyhexatin on commodities for which 
import tolerances exist exceed the Agency's level of concern. However, 
EPA also determined that if the only cyhexatin tolerance is for orange 
juice, there is a reasonable certainty that no harm to any population 
subgroup will result from exposure to cyhexatin treated oranges. 
Because manufacturers support a cyhexatin tolerance on orange juice for 
purposes of importation and the Agency has made a determination of 
safety for such a tolerance, EPA is also proposing that, concurrent 
with the revocation of the citrus fruit group tolerance, an individual 
time-limited tolerance be established for orange juice. The regulatory 
actions proposed in this document contribute toward the Agency's 
tolerance reassessment requirements under 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 41 tolerances which 
would be counted as tolerance reassessments toward the August 2006 
review deadline.

DATES: Comments must be received on or before August 26, 2005.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number OPP-2005-0160, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
     Agency Website: https://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-2005-0160.
     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-2005-0160.
     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-2005-0160. 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-
0160. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available online at 
https://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

[[Page 43369]]

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 https://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 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 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 (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at https://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

A. What Action is the Agency Taking?

    The last U.S. product registration for cyhexatin was canceled in 
1989. On January 21, 1998 (63 FR 3057) (FRL-5743-8), EPA published a 
proposal in the Federal Register to revoke tolerances for canceled 
active ingredients, including cyhexatin. In a Federal Register final 
rule of October 26, 1998 (63 FR 57062) (FRL-6035-8), EPA responded to 
comments received during a 60-day public comment period on proposed 
tolerance revocations. The California Citrus Quality Council and the 
U.S. Hop Industry Plant Protection Committee expressed concern about 
proposed tolerance revocations pertaining to residues of cyhexatin on 
citrus and hops, respectively. Elf Atochem North America, Inc. (now 
known as CEREXAGRI, Inc.) and OXON ITALIA expressed an interest in 
maintaining specific cyhexatin import tolerances. Elf Atochem stated 
that it had pending applications for registration and was developing 
certain data. OXON ITALIA stated that it was committed to providing 
data required to maintain tolerances of cyhexatin on imported citrus 
crops. Therefore, EPA did not revoke the cyhexatin tolerances at that 
time.
    Recently, EPA completed its Tolerance Reassessment Eligibility 
Decision (TRED) for cyhexatin. In the Federal Register of July 13, 2005 
(70 FR 40341) (FRL-7720-3), EPA published a decision notice for the 
cyhexatin TRED. The TRED and documents in support of the TRED are 
available in Edocket ID number OPP-2004-0295 at https://www.epa.gov/
edocket, and will also be made available via the reregistration status 
website at https://www.epa.gov/pesticides/reregistration/status.htm. 
Because there are no active U.S. registrations, human exposure to this 
pesticide is strictly through the consumption of treated imported 
foods. Residential and occupational exposures as well as dietary 
exposure through drinking water are not expected because there is no 
domestic use of cyhexatin.

[[Page 43370]]

    There are currently 41 tolerances for cyhexatin. Currently, EPA 
determined that acute dietary risks from use of cyhexatin on 
commodities for which import tolerances exist exceed the Agency's level 
of concern. Therefore, manufacturers had indicated that they would 
support only the import tolerances for apple (fresh, juice, sauce, and 
dried) and citrus (orange juice). However, the estimated acute dietary 
risks from use of cyhexatin on these commodities exceed the Agency's 
level of concern. The assessment concluded that for apples and oranges, 
the acute dietary exposure estimate for children 1-2 years of age is at 
223% of the acute population-adjusted dose (aPAD) at the 99.9th 
percentile; for all infants < 1 year of age at 187% of the aPAD, and 
for children 3-5 years of age at 151% of the aPAD. Apple juice and 
apple sauces were the risk drivers.
    Because of this acute dietary concern, manufacturers have withdrawn 
support for cyhexatin tolerances, except for orange juice. EPA has 
evaluated the dietary risks from the importation of orange juice 
concentrate to be processed into orange juice and has determined that 
there is reasonable certainty that no harm to any population subgroup 
will result from exposure to cyhexatin treated oranges. The acute 
dietary exposure estimates for orange juice only are below the Agency's 
level of concern for all population subgroups. The most highly exposed 
sub-population was children 1-2 years of age, at 35% of the aPAD.
    Therefore, EPA is proposing to revoke all existing tolerances for 
residues of the insecticide/acaricide cyhexatin under FFDCA section 
408(e)(1) because existing tolerances do not meet requirements of FFDCA 
section 408(b)(2).
    Specifically, EPA is proposing to revoke the tolerances in 40 CFR 
180.144 for combined residues of cyhexatin and its organotin 
metabolites (calculated as cyhexatin) in or on the following food 
commodities: almond; almond, hulls; apple; cattle, fat; cattle, kidney; 
cattle, liver; cattle, meat byproducts, except kidney and liver; 
cattle, meat; citrus, dried pulp; fruit, citrus; goat, fat; goat, 
kidney; goat, liver; goat, meat byproducts, except kidney and liver; 
goat, meat; hog, fat; hog, kidney; hog, liver; hog, meat byproducts, 
except kidney and liver; hog, meat; hop; hop, dried cone; horse, fat; 
horse, kidney; horse, liver; horse, meat byproducts, except kidney and 
liver; horse, meat; milk, fat (=N in whole milk); nectarine; nut, 
macadamia; peach; pear; plum, prune, dried; plum, prune, fresh; sheep, 
fat; sheep, kidney; sheep, liver; sheep, meat byproducts, except kidney 
and liver; sheep, meat; strawberry; and walnut.
    However, concurrent with the proposed revocation of the crop group 
tolerance on fruit, citrus in 40 CFR 180.144 at 2 parts per million 
(ppm), a tolerance on orange juice should be established at 0.1 ppm. 
Available processing data indicate that cyhexatin residues of concern 
in orange juice concentrate were less than the limit of quantitation; 
i.e., less than 0.1 ppm. Nevertheless, additional generic data is 
needed for EPA to confirm processing, analytical method, and 
toxicological data. 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 tolerance provide the necessary 
information. Therefore, EPA is proposing to establish an individual 
time-limited tolerance in 40 CFR 180.144 for combined residues of 
cyhexatin and its organotin metabolites (calculated as cyhexatin) in 
orange, juice at 0.1 ppm with an expiration/revocation date of June 13, 
2009; i.e., the time-limited tolerance will be established for a period 
of 4 years from the TRED completion date of June 13, 2005 in order to 
allow sufficient time for the Agency to issue a data call-in request, 
the manufacturers to submit the needed data, and for the Agency to 
review it. After reviewing the available data, EPA will decide whether 
there is sufficient data to support the orange juice tolerance as a 
permanent one. If the requisite information is not submitted, EPA may 
issue an order revoking the tolerance at issue or allow the time-
limited tolerance to expire.
    Because, with the exception of orange juice, EPA cannot make a 
determination of safety concerning the specific cyhexatin tolerances 
proposed herein for revocation, the Agency has determined that for good 
cause and in the public interest, it will provide a shorter period of 
30 days for public comment under FFDCA section 408(e)(2), instead of 
the typical 60 days for proposed rulemaking. Cyhexatin is used on a 
number of children's foods, including apples, that can currently be 
imported. EPA's risk assessment has concluded that there is a concern 
for infants and children resulting from acute dietary exposure to these 
imported commodities treated with cyhexatin. The Agency expects that a 
decrease in the public comment period for this proposed rule would 
hasten the cyhexatin tolerance revocation process and thus reduce 
exposure to cyhexatin for infants and children more quickly.

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 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

[[Page 43371]]

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.
    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 specific cyhexatin tolerances 
and establishment of the time-limited tolerance on orange juice become 
effective on the date of publication of the final rule in the Federal 
Register.
    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 
that were in existence on August 2, 1996. As of July 18, 2005, EPA has 
reassessed over 7,330 tolerances. This document proposes to revoke a 
total of 41 tolerances which would be counted in a final rule as 
tolerance reassessments toward the August 2006 review deadline under 
FFDCA section 408(q), as amended by FQPA in 1996. For counting 
purposes, the Agency will count the citrus fruit group tolerance as one 
revocation (where an individual tolerance for orange juice would be 
established in its place).

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 https://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 https://
www.epa.gov/fedrgstr/.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to establish a tolerance 
under FFDCA section 408(e) and also revoke specific tolerances 
established under FFDCA section 408. The Office of Management and 
Budget (OMB) has exempted these types of actions (i.e., establishment 
of a tolerance and 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, 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 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 establishment of 
tolerances or 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. These analyses for tolerance 
establishments and revocations were published on May 4, 1981 (46 FR 
24950) and on December 17, 1997 (62 FR 66020), respectively, and were 
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

[[Page 43372]]

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: July 18, 2005.

James Jones,
Director, Office of Pesticide Programs.

0
Therefore, it is proposed that 40 CFR chapter I be 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 180.144 is amended by revising the table in paragraph (a) to 
read as follows:


Sec.  180.144  Cyhexatin; tolerances for residues.

    (a)General. * * *

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Orange, juice...................  0.1...............  06/13/2009
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-14738 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S