
[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Rules and Regulations]
[Pages 40811-40815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17365]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0327; FRL-8878-6]


Maneb; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking all the tolerances for the fungicide maneb 
with expiration/revocation dates that provide sufficient time to use 
existing stocks of the canceled registrations for the last food uses of 
maneb in the United States.

DATES: This regulation is effective July 12, 2011. Objections and 
requests for hearings must be received on or before September 12, 2011 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0327. 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., Confidential Business Information (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 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 Docket 
Facility is open 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: 
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

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producer, food manufacturer, or pesticide manufacturer. Potentially 
affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 
408(g), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
You must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2010-0327 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before September 12, 2011. 
Addresses for mail and hand delivery of objections and hearing requests 
are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0327, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     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.

II. Background

A. What action is the Agency taking?

    In the Federal Register of May 26, 2010 (75 FR 29475) (FRL-8826-2), 
EPA issued a proposal to revoke all the tolerances for residues of the 
fungicide maneb after receipt and approval of requests for voluntary 
cancellation by registrants of the last registrations for food uses of 
maneb in the United States. Also, the proposal provided a 60-day 
comment period which invited public comment for consideration and for 
support of tolerance retention under FFDCA standards.
    In this final rule, EPA is revoking all the tolerances for the 
fungicide maneb, with delayed expiration/revocation dates in response 
to public comments requesting more time to use existing stocks of the 
canceled registrations. In addition, EPA had proposed in the May 26, 
2010 issue of the Federal Register to remove the expired tolerance in 
40 CFR 180.110(b) for maneb residues in or on walnut, and reserve that 
paragraph. However, EPA previously removed that expired tolerance and 
reserved that paragraph in a final rule published in the Federal 
Register of June 15, 2011 (76 FR 34883) (FRL-8875-4). Therefore, no 
further changes are being made to 40 CFR 180.110(b).
    In response to the proposal published in the Federal Register of 
May 26, 2010 (75 FR 29475), EPA received comments during the 60-day 
public comment period, as follows:
    Comments. Commenters from the Regional Vegetable Extension Agent 
with the University of Florida, the Pesticide Safety Education Program 
of Oklahoma State University, and two growers requested that maneb use 
be extended until exhaustion for pepper, lettuce, grapes grown for 
wine, and leafy vegetables. One commenter requested that maneb use on 
broccoli, cabbage, and lettuce be extended for 5 years. Most comments 
received from multiple individual growers and also from the Cranberry 
Institute, the Department of Plant and Environmental Protection 
Sciences, College of Tropical Agriculture and Human Resources of the 
University of Hawaii, Florida Fruit and Vegetable Association, Arizona 
Pest Management Center, California's Glenn County Department of 
Agriculture, California's Tehama County Department of Agriculture, and 
Colorado Department of Agriculture, requested that maneb use be 
extended (for use on commodities such as almond, broccoli, cabbage, 
celery, cranberry, eggplant, lettuce, onion, pepper, potato, and 
tomato) and for timeframes ranging from a few months to over 2 years; 
i.e., the end of 2012.
    Agency response. In the Federal Register of May 26, 2010 (75 FR 
29475) (FRL-8826-2), EPA proposed to revoke the maneb tolerances on the 
date of final rule publication in the Federal Register, which the 
Agency expected to occur in 2010. Based on the comments received, the 
Agency agrees that there is a need for more time to exhaust existing 
stocks of maneb. Therefore, EPA is revoking the tolerances for maneb in 
40 CFR 180.110 with the expiration/revocation dates of December 31, 
2012. The Agency believes the extended time is sufficient and 
consistent with the general outlook of the public comments received.

B. What is the Agency's authority for taking this action?

    EPA may issue a regulation revoking tolerances under FFDCA section 
408(e). EPA's general practice is to revoke tolerances for residues of 
pesticide active ingredients on crops for which the Federal 
Insecticide, Fungicide, and Rodenticide Act (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

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require these import tolerances, the Agency believes it is appropriate 
to revoke tolerances for unregistered pesticides in order to prevent 
potential misuse.

C. When do these actions become effective?

    As noted in the DATES section, this regulation is effective on the 
date of the publication in the Federal Register. In this final rule, 
EPA is revoking all the maneb tolerances with expiration/revocation 
dates of December 31, 2012. Based on the comments received during the 
60-day public comment period, the Agency believes that the expiration/
revocation dates allow users to exhaust existing stocks and allow 
sufficient time for passage of treated commodities through the channels 
of trade.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the tolerance revocations, shall 
be subject to FFDCA section 408(1)(5), as established by the Food 
Quality Protection Act (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.
    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 that 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 FFDCA 
section 408(b)(4). 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, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for maneb per se, but has MRLs 
for total dithiocarbamates (which includes the dithiocarbamate maneb), 
determined as carbon disulfide.

IV. Statutory and Executive Order Reviews

    In this final rule, EPA revokes specific tolerances established 
under FFDCA section 408. The Office of Management and Budget (OMB) has 
exempted this type of action (i.e., a tolerance revocation for which 
extraordinary circumstances do not exist) from review under Executive 
Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 
October 4, 1993). Because this rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this rule is not 
subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any special considerations as required by Executive Order 
12898, entitled Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994); or OMB review or any other Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272 note). 
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency previously assessed whether revocations of 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 rule, 
the Agency hereby certifies that this final rule will not have a 
significant 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 the proposed rule, as mentioned in Unit II.A.). Furthermore, 
for the pesticides named in this final rule, the Agency knows of no 
extraordinary circumstances that exist as to the present revocations 
that would change EPA's previous analysis. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 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

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implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 29, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.110 is amended by revising the table in paragraph (a) to 
read as follows:


Sec.  180.110  Maneb; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                            Expiration/
               Commodity                    Parts per       revocation
                                             million           date
------------------------------------------------------------------------
Almond.................................              0.1        12/31/12
Apple..................................              2          12/31/12
Apricot................................             10          12/31/12
Banana (not more than 0.5 part per                   4          12/31/12
 million shall be in the pulp after
 peel is removed and discarded
 (preharvest application only))........
Bean, dry, seed........................              7          12/31/12
Bean, succulent........................             10          12/31/12
Beet, sugar, tops......................             45          12/31/12
Broccoli...............................             10          12/31/12
Brussels sprouts.......................             10          12/31/12
Cabbage................................             10          12/31/12
Cabbage, Chinese, bok choy.............             10          12/31/12
Cabbage, Chinese, napa.................             10          12/31/12
Carrot, roots..........................              7          12/31/12
Cauliflower............................             10          12/31/12
Celery.................................              5          12/31/12
Collards...............................             10          12/31/12
Corn, sweet, kernel plus cob with husks              5          12/31/12
 removed...............................
Cranberry..............................              7          12/31/12
Cucumber...............................              4          12/31/12
Eggplant...............................              7          12/31/12
Endive.................................             10          12/31/12
Fig....................................              7          12/31/12
Grape..................................              7          12/31/12
Kale...................................             10          12/31/12
Kohlrabi...............................             10          12/31/12
Lettuce................................             10          12/31/12
Melon..................................              4          12/31/12
Mustard greens.........................             10          12/31/12
Nectarine..............................             10          12/31/12
Onion..................................              7          12/31/12
Papaya.................................             10          12/31/12
Peach..................................             10          12/31/12
Pepper.................................              7          12/31/12
Potato.................................              0.1        12/31/12
Pumpkin................................              7          12/31/12
Squash, summer.........................              4          12/31/12
Squash, winter.........................              4          12/31/12
Tomato.................................              4          12/31/12
Turnip, greens.........................             10          12/31/12
Turnip, roots..........................              7          12/31/12
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[FR Doc. 2011-17365 Filed 7-11-11; 8:45 am]
BILLING CODE 6560-50-P


