[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) * * *
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Expiration/
Commodity Parts per revocation
million date
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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]
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