Document ID: EPA-HQ-OPP-2011-0507-0006
Agency: epa
Document Type: Rule
Title: Tolerance Actions: Dicloran and Formetanate
Posted Date: 2012-07-11T04:00Z

[Federal Register Volume 77, Number 133 (Wednesday, July 11, 2012)]
[Rules and Regulations]
[Pages 40812-40815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16961]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0507; FRL-9353-7]
RIN 2070-ZA16

Dicloran and Formetanate; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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[[Page 40813]]

SUMMARY: EPA is revoking certain tolerances for the fungicide dicloran 
and the insecticide formetanate hydrochloride in follow-up to amended 
registrations that deleted specific uses, leaving no dicloran and 
formetanate hydrochloride registrations for those uses. Also, in 
accordance with current Agency practice, EPA is making minor revisions 
to the tolerance expressions for dicloran and formetanate hydrochloride 
and to specific tolerance nomenclatures for dicloran.

DATES: This regulation is effective July 11, 2012. Objections and 
requests for hearings must be received on or before September 10, 2012, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0507, is available either 
electronically through http://www.regulations.gov or in hard copy at 
the OPP Docket in the Environmental Protection Agency Docket Center 
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805. Please review 
the visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

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; email address: 
nevola.joseph@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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-
2011- 0507 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 10, 2012. 
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-2011-0507, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    In the Federal Register of March 28, 2012 (77 FR 18748) (FRL-9340-
9), EPA issued a rule that proposed to revoke certain tolerances for 
the fungicide dicloran and the insecticide formetanate hydrochloride in 
follow-up to amended registrations that deleted specific uses, leaving 
no dicloran and formetanate hydrochloride registrations for those uses, 
and make minor revisions to the tolerance expressions for dicloran and 
formetanate hydrochloride and to specific tolerance nomenclatures for 
dicloran. Also, the proposed rule of March 28, 2012 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 certain tolerances because 
either they are no longer needed or are associated with food uses that 
are no longer registered under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) in the United States. Those instances where 
registrations were canceled were because the registrant failed to pay 
the required maintenance fee and/or the registrant voluntarily 
requested cancellation of one or more registered uses of the pesticide 
active ingredient. The tolerances revoked by this final rule are no 
longer necessary to cover residues of the relevant pesticides in or on 
domestically treated commodities or commodities treated outside but 
imported into the United States. It is EPA's general practice to issue 
a final rule revoking those tolerances and tolerance exemptions for 
residues of pesticide active ingredients on crop uses for which there 
are no active registrations under FIFRA, unless any person in comments 
on the proposal indicates a need for the tolerance or tolerance 
exemption to cover residues in or on imported commodities or legally 
treated domestic commodities.
    EPA has historically been concerned that retention of tolerances 
that are not necessary to cover residues in or on

[[Page 40814]]

legally treated foods may encourage misuse of pesticides within the 
United States.
    Generally, EPA will proceed with the revocation of these tolerances 
on the grounds discussed in Unit II.A. if one of the following 
conditions applies:
    1. Prior to EPA's issuance of a FFDCA section 408(f) order 
requesting additional data or issuance of a FFDCA section 408(d) or (e) 
order revoking the tolerances on other grounds, commenters retract the 
comment identifying a need for the tolerance to be retained.
    2. EPA independently verifies that the tolerance is no longer 
needed.
    3. The tolerance is not supported by data that demonstrate that the 
tolerance meets the requirements under the Food Quality Protection Act 
(FQPA).
    In response to the proposed rule published in the Federal Register 
of March 28, 2012 (77 FR 18748), EPA received no comments during the 
60-day public comment period. Therefore, EPA is finalizing the actions 
proposed concerning dicloran and formetanate hydrochloride in the 
Federal Register of March 28, 2012 (77 FR 18748) (FRL-9340-9). For a 
detailed discussion of the Agency's rationale for the finalized 
tolerance actions, refer to the proposed rule of March 28, 2012.

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

    EPA's general practice is to revoke 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.

C. When do these actions become effective?

    As stated in the DATES section, this final rule is effective July 
11, 2012. However, EPA is revoking the dicloran tolerance on potato 
with an expiration/revocation date of December 31, 2014 and the 
formetanate hydrochloride tolerances on apple; apple, wet pomace; 
peach; and pear with expiration/revocation dates of December 31, 2013. 
The Agency believes that these expiration/revocation dates allow users 
to exhaust 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 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 United Nations 
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 formetanate hydrochloride 
or MRL for dicloran in or on potatoes.

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

[[Page 40815]]

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 FFDCA section 408(n)(4). 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 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: July 2, 2012.
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. Revise Sec.  180.200 to read as follows:

Sec.  180.200  Dicloran; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide dicloran, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only dicloran, 2,6-dichloro-4-nitroaniline, in or on the 
commodity.

------------------------------------------------------------------------
                                       Parts per   Expiration/revocation
              Commodity                 million             date
------------------------------------------------------------------------
Apricot.............................        20     None.
Bean, snap, succulent...............        20     None.
Carrot, roots.......................        10     11/2/11.
Celery..............................        15     None.
Cherry, sweet.......................        20     None.
Cucumber............................         5     None.
Endive..............................        10     None.
Garlic..............................         5     None.
Grape...............................        10     None.
Lettuce.............................        10     None.
Nectarine...........................        20     None.
Onion...............................        10     None.
Peach...............................        20     None.
Plum, prune, fresh..................        15     None.
Potato..............................         0.25  12/31/14.
Rhubarb.............................        10     None.
Sweet potato, roots.................        10     None.
Tomato..............................         5     None.
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registrations. [Reserved].
    (d) Indirect or inadvertent residues. [Reserved].

0
3. Revise Sec.  180.276 to read as follows:

Sec.  180.276  Formetanate hydrochloride; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide formetanate hydrochloride, including its metabolites and 
degradates, in or on the commodities in the table in this paragraph. 
Compliance with the tolerance levels specified in this paragraph is to 
be determined by measuring only formetanate hydrochloride, N,N-
dimethyl-N'-[3-[(methylamino)carbonyl]oxy]phenyl]methanimidamide 
hydrochloride, in or on the commodity.

------------------------------------------------------------------------
                                       Parts per   Expiration/revocation
              Commodity                 million             date
------------------------------------------------------------------------
Apple...............................         0.50  12/31/13.
Apple, wet pomace...................         1.5   12/31/13.
Grapefruit..........................         1.5   None.
Lemon...............................         0.60  None.
Lime................................         0.03  None.
Nectarine...........................         0.40  None.
Orange..............................         1.5   None.
Peach...............................         0.40  12/31/13.
Pear................................         0.50  12/31/13.
Tangelo.............................         0.03  None.
Tangerine...........................         0.03  None.
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registrations. [Reserved].
    (d) Indirect or inadvertent residues. [Reserved].

[FR Doc. 2012-16961 Filed 7-10-12; 8:45 am]
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