[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Proposed Rules]
[Pages 29475-29479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12376]



[[Page 29475]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0327; FRL-8826-2]


Maneb; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke all the tolerances for the 
fungicide maneb because the Agency has approved requests for voluntary 
cancellation by registrants of the last registrations for the food uses 
of maneb in the United States.

DATES: Comments must be received on or before July 26, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0327, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0327. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, 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 regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
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 regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the 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.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-evaluation 
Division (7508P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-
0001; telephone number: (703) 308-8037; e-mail address: 
<a href="/cdn-cgi/l/email-protection#a9c7ccdfc6c5c887c3c6daccd9c1e9ccd9c887cec6df"><span class="__cf_email__" data-cfemail="b3ddd6c5dcdfd29dd9dcc0d6c3dbf3d6c3d29dd4dcc5">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through 
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 document 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.

[[Page 29476]]

    viii. Make sure to submit your comments by the comment period 
deadline identified.

C. 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 
section 408(f) of the Federal Food, Drug, and Cosmetic Act (FFDCA), if 
needed. The order would specify data needed and the timeframes 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.
    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 all the tolerances for residues of the 
fungicide maneb, manganous ethylenebisdithiocarbamate, because the 
Agency has approved requests for voluntary cancellation by registrants 
of the last registrations for food uses of maneb in the United States. 
These tolerances are associated with food uses that are no longer 
registered under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), and therefore are no longer needed. It is EPA's general 
practice to propose revocation of those tolerances/tolerance exemptions 
for residues of pesticide active ingredients on crop uses for which 
there are no active registrations under FIFRA, unless any person 
submits comments on the proposal that indicate a need for the tolerance 
to cover residues in or on imported commodities or legally treated 
domestic commodities.
    EPA completed a Reregistration Eligibility Decision (RED) for maneb 
in 2005, which included a tolerance reassessment summary for maneb. As 
part of the tolerance reassessment, the Agency recommended specific 
changes to the tolerance definition for maneb, changes to tolerance 
values, tolerances to be revoked, and new tolerances to be proposed to 
be established. EPA also reviewed any Codex Alimentarius maximum 
residue limits (MRLs) for maneb. Because Codex has no established MRLs 
for maneb per se, but groups MRLs for maneb with MRLs for 
dithiocarbamate pesticides expressed in terms of parts per million 
(ppm) carbon disulfide, EPA recommended harmonizing with Codex by 
changing the tolerance definition for maneb, so that it is expressed in 
terms of carbon disulfide.
    In the maneb RED, the Agency recommended revocation of certain 
maneb tolerances which still exist in 40 CFR 180.110(a). Maneb use on 
certain crops was disallowed by EPA, as announced in a notice published 
in the Federal Register of March 2, 1992 (57 FR 7484) (FRL-4045-8). In 
that notice, the Agency announced its conclusion of Special Review 
(PD4) regarding ethylene bisdithiocarbamate (EBDC) fungicides, 
including maneb, and its intent to cancel any EBDC product 
registrations bearing food uses that included, among others, apricots, 
succulent beans, carrots, celery, nectarines, and peaches. There have 
been no U.S. registrations for maneb use on apricots, succulent beans, 
nectarines, and peaches since 1992, and no U.S. registrations for maneb 
use on carrots and celery since 1994. Therefore, the maneb tolerances 
on these commodities are no longer needed and should be revoked. 
Consequently, EPA is proposing to revoke the tolerances in 40 CFR 
180.110(a) for maneb residues of concern in or on apricot; bean, 
succulent; carrot, roots; celery; nectarine; and peach.
    Subsequent to the RED, all maneb technical and end-use registrants 
chose to request voluntary cancellation of all U.S. registrations for 
maneb technical grade active ingredient and end-use maneb products. 
Registrants submitted their voluntary requests for cancellation of 
their maneb technical and product registrations to EPA in accordance 
with section 6(f) of FIFRA, and the Agency published notices of their 
receipt and subsequent cancellation orders in the Federal Register, 
which are summarized herein.
    In a Federal Register notice of September 12, 2008 (73 FR 53007) 
(FRL-8380-7), EPA announced receipt of a request from United 
Phosphorous Inc. to voluntarily cancel all of its maneb registrations. 
EPA accepted this request and published a cancellation order, for all 
United Phosphorous maneb products, in a Federal Register notice of 
August 26, 2009 (74 FR 43124)(FRL-8429-6), effective on August 26, 
2009. Under conditions of the cancellation order, United Phosphorous 
Inc. was permitted to sell and distribute existing stocks of the 
canceled maneb products until December 31, 2009. Also, this order 
permitted persons other than the registrant to sell and distribute 
existing stocks of the canceled maneb products until supplies were 
exhausted and formulate end use products until March 2010.
    In a Federal Register notice of January 6, 2010 (75 FR 860) (FRL-
8806-3), EPA announced the Agency's receipt of a request from Drexel 
Chemical Company to voluntarily cancel its technical registration for 
maneb and thereby terminate the last maneb technical product registered 
in the United States (EPA Reg. No. 19713-377). After the close of the 
30-day comment period, EPA approved cancellation of this last maneb 
technical product, and issued a cancellation order in the Federal 
Register notice of February 24, 2010 (75 FR 8340) (FRL-8813-9), 
effective on February 24, 2010. Under conditions of the cancellation 
order, Drexel Chemical Company was permitted to sell and distribute 
existing stocks of the canceled maneb technical product until February 
26, 2010 and formulate end-use products until March 10, 2010. Also, 
this order permitted persons other than the registrants to use the 
maneb end-use products until supplies are exhausted.
    In another Federal Register notice of January 6, 2010 (75 FR 869) 
(FRL-8806-2), EPA announced the Agency's receipt of request from Drexel 
Chemical Company to voluntarily cancel its last maneb registrations. 
After the close of the 30-day comment period, EPA approved cancellation 
of the registrations, and issued a cancellation order in a Federal 
Register notice of February 26, 2010 (75 FR 8942) (FRL-8813-6), 
effective February 26, 2010. Under conditions of the cancellation 
order, Drexel Chemical Company was permitted to sell and distribute 
existing stocks of the canceled maneb products until supplies are 
exhausted. Also, this order permitted persons other than the 
registrants to sell, distribute, and use existing stocks of the 
canceled maneb products until supplies are exhausted.
    Also, in a Federal Register notice of March 4, 2010 (75 FR 9896) 
(FRL-8813-5), EPA announced the Agency's receipt

[[Page 29477]]

of requests from DuPont Crop Protection to voluntarily cancel their 
maneb product registration (EPA Reg. No. 352-655), the last maneb 
product registered for use in the United States, thereby terminating 
the last maneb food uses in the United States. After the close of the 
30-day comment period, EPA approved cancellation of this product 
registration and issued a cancellation order in the Federal Register of 
April 16, 2010 (75 FR 19967) (FRL-8822-2), effective on April 16, 2010. 
Under conditions of the cancellation order, DuPont Crop Protection was 
permitted to sell and distribute existing stocks of the canceled maneb 
product until supplies are exhausted. Also, this order permitted 
persons other than the registrants to sell, distribute, and use 
existing stocks of the canceled maneb product until supplies are 
exhausted.
    In the time since the last cancellation order, the Agency has 
received information from the registrants that significant levels of 
existing stocks of the canceled maneb products are unlikely. Therefore, 
the Agency believes that end users have had sufficient time to exhaust 
those existing stocks and for maneb treated commodities to have cleared 
the channels of trade. The termination of the last food uses means that 
the tolerances will no longer be needed and should be revoked. 
Consequently, EPA is proposing to revoke the tolerances in 40 CFR 
180.110(a) on almond; apple; banana (not more than 0.5 part per million 
shall be in the pulp after peel is removed and discarded (preharvest 
application only)); bean, dry, seed; beet, sugar, tops; broccoli; 
Brussels sprouts; cabbage; cabbage, Chinese, bok choy; cabbage, 
Chinese, napa; cauliflower; collards; corn, sweet, kernel plus cob with 
husks removed; cranberry; cucumber; eggplant; endive; fig; grape; kale; 
kohlrabi; lettuce; melon; mustard greens; onion; papaya; pepper; 
potato; pumpkin; squash, summer; squash, winter; tomato; turnip, 
greens; and turnip, roots. EPA is proposing that these revocations 
become effective on the date of publication of the final rule for maneb 
in the Federal Register.
    Because the time-limited tolerance associated with the use of maneb 
under a FIFRA section 18 emergency exemption for combined maneb 
residues of concern in or on walnut expired on December 31, 2009, it 
should be removed. Therefore, EPA is proposing to remove the expired 
tolerance in 40 CFR 180.110(b) on walnut.

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 Food Quality Protection Act (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 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/
tolerance exemptions 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 FFDCA, a tolerance/tolerance exemption 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/tolerance 
exemptions for residues on crops uses for which FIFRA registrations no 
longer exist, unless someone expresses a need for such tolerances/
tolerance exemptions. 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/tolerance 
exemptions should be aware that additional data may be needed to 
support retention. These parties should be aware that, under section 
408(f) of FFDCA, 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/tolerance 
exemption at issue.

C. When Do These Actions Become Effective?

    EPA is proposing that revocation of these maneb tolerances and 
removal of the expired maneb tolerance become effective on the date of 
publication of the final rule in the Federal Register. Most of the 
maneb tolerances proposed for revocation in this document are 
associated with uses that have been canceled in 2010. However, the 
available information on recently canceled maneb products indicates 
that significant levels of existing stocks are unlikely. Therefore, the 
Agency believes that existing stocks of maneb products labeled for uses 
associated with tolerances proposed for revocation have been completely 
exhausted and that maneb treated commodities have had sufficient time 
for passage through the

[[Page 29478]]

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 that information prior to moving 
forward with tolerance revocation. 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 section 408(l)(5) of FFDCA, 
as established by FQPA. Under this unit, 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.

III. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by section 
408(b)(4) of FFDCA. The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, section 408(b)(4) of FFDCA requires that EPA 
explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for maneb per se.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific 
tolerances established under section 408 of FFDCA. The Office of 
Management and Budget (OMB) has exempted this type of action (e.g., 
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 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) (FRL-5753-1), 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 rule 
will not have a significant negative economic impact on a substantial 
number of small entities. In a memorandum dated May 25, 2001, EPA 
determined that eight conditions must all be satisfied in order for an 
import tolerance or tolerance exemption revocation to adversely affect 
a significant number of small entity importers, and that there is a 
negligible joint probability of all eight conditions holding 
simultaneously with respect to any particular revocation. (This Agency 
document is available in the docket of this proposed rule). 
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 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 9, 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

[[Page 29479]]

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: May 14, 2010.
Steven Bradbury,
Acting 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.  180.110  [Removed]

    2. Section 180.110 is removed.
[FR Doc. 2010-12376 Filed 5-25-10; 8:45 am]
BILLING CODE 6560-50-S


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