Document ID: EPA-HQ-OPP-2008-0823-0001
Agency: epa
Document Type: Rule
Title: Multiple Chemicals; Extension of Tolerances for Emergency Exemptions
Posted Date: 2009-01-07T05:00Z

[Federal Register: January 7, 2009 (Volume 74, Number 4)]
[Rules and Regulations]               
[Page 634-636]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja09-5]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0823; FRL-8392--3]

 
Multiple Chemicals; Extension of Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation extends time-limited tolerances for the 
pesticides listed in Unit II. of the SUPPLEMENTARY INFORMATION. These 
actions are in response to EPA's granting of emergency exemptions under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of these pesticides. Section 408(l)(6) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish 
a time-limited tolerance or exemption from the requirement for a 
tolerance for pesticide chemical residues in food that will result from 
the use of a pesticide under an emergency exemption granted by EPA.

DATES: This regulation is effective January 7, 2009. Objections and 
requests for hearings must be received on or before March 9, 2009, 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-2008-0823. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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 either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (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: See the table in this unit for the 
name of a specific contact person. The following information applies to 
all contact persons: Emergency Response Team, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW, Washington, DC 20460-0001.

------------------------------------------------------------------------
         Pesticide/CFR Citation                   Contact Person
------------------------------------------------------------------------
Formetanate hydrochloride                 Andrew Ertman
180.276.................................  ertman.andrew@epa.gov
                                          703-308-9367
------------------------------------------------------------------------
Maneb                                     Libby Pemberton
180.110.................................  pemberton.libby@epa.gov
                                          703-308-9364
------------------------------------------------------------------------
Myclobutanil                              Stacey Groce
180.443.................................  groce.stacey@epa.gov
                                          703-30-2505
------------------------------------------------------------------------
Thiophanate methyl                        Andrea Conrath
180.371.................................  conrath.andrea@epa.gov
                                          703-308-9356
------------------------------------------------------------------------

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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions discussed above. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult

[[Page 635]]

the person listed under FOR FURTHER INFORMATION CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2008-0823 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before March 9, 2009.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0823, 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'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 and Statutory Findings

    EPA published final rules in the Federal Register for each 
pesticide listed. The initial issuance of these final rules announced 
that EPA, on its own initiative, under section 408 of FFDCA, 21 U.S.C. 
346a, as amended by the Food Quality Protection Act of 1996 (FQPA) 
(Public Law 104-170), was establishing time-limited tolerances.
    EPA established the tolerances because section 408(l)(6) of FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under FIFRA section 18. Such tolerances can be 
established without providing notice or time for public comment.
    EPA received requests to extend the use of these chemicals for this 
year's growing season. After having reviewed these submissions, EPA 
concurs that emergency conditions exist. EPA assessed the potential 
risks presented by residues for each chemical. In doing so, EPA 
considered the safety standard in section 408(b)(2) of FFDCA, and 
decided that the necessary tolerance under section 408(l)(6) of FFDCA 
would be consistent with the safety standard and with FIRA section 18.
    The data and other relevant material have been evaluated and 
discussed in the final rule originally published to support these uses. 
Based on that data and information considered, the Agency reaffirms 
that extension of these time-limited tolerances will continue to meet 
the requirements of section 408(l)(6) of FFDCA. Therefore, the time-
limited tolerances are extended until the date listed. EPA will publish 
a document in the Federal Register to remove the revoked tolerances 
from the Code of Federal Regulations (CFR). Although these tolerances 
will expire and are revoked on the date listed, under section 408(l)(5) 
of FFDCA, residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on the commodity after that 
date will not be unlawful, provided the residue is present as a result 
of an application or use of a pesticide at a time and in a manner that 
was lawful under FIFRA, the tolerance was in place at the time of the 
application, and the residue does not exceed the level that was 
authorized by the tolerance. EPA will take action to revoke these 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Tolerances for the use of the following pesticide chemicals on 
specific commodities are being extended:
    1. Formetanate hydrochloride. EPA has authorized under FIFRA 
section 18 the use of formetanate hydrochloride on bulb onions for 
control of thrips in Colorado, Idaho, Michigan, New York, Ohio, Oregon, 
Washington, and Wisconsin. This regulation extends a time-limited 
tolerance for residues of the insecticide formetanate hydrochloride, 
(m-[[(dimethylamino) methylene]amino]phenyl methylcarbamate 
hydrochloride, in or on onion, dry bulb at 0.02 parts per million (ppm) 
for an additional 1-year period. This tolerance will expire and is 
revoked on December 31, 2009. A time-limited tolerance was originally 
published in the Federal Register of February 20, 2008 (73 FR 9226) 
(FRL-8343-6).
    2. Maneb. EPA has authorized under FIFRA section 18 the use of 
Maneb on walnuts for control of bacterial blight in California. This 
regulation extends a time-limited tolerance for combined residues of 
the fungicide maneb (manganous ethylenebisdithiocarbamate) calculated 
as zinc ethylenebisdithiocarbamate, and its metabolite ethylenethiourea 
in or on walnuts at 0.05 ppm for an additional 1-year period. This 
tolerance will expire and is revoked on December 31, 2009. A time-
limited tolerance was originally published in the Federal Register of 
March 17, 1999 (64 FR 13097) (FRL-6067-9). The time-limited tolerance 
exemption was last extended on December 21, 2005 at 70 FR 75734.
    3. Myclobutanil. EPA has authorized under FIFRA section 18 the use 
of myclobutanil on legume vegetables for control of soybean rust in 
various States. This regulation extends time-limited tolerances for 
combined residues of the fungicide, myclobutanil, alpha-butyl-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile, and its alcohol 
metabolite, alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-
triazole-1-propanenitrile (free and bound), in or on vegetable, foliage 
of legume, group 07, and vegetable, legume, group 06 at 1.0 ppm for an 
additional 6-month period. These tolerances will expire and are revoked 
on December 31, 2009. Time-limited tolerances were originally published 
in the Federal Register of June 28, 2006 (71 FR 36687) (FRL-8068-2).

[[Page 636]]

    4. Thiophanate methyl. EPA has authorized under FIFRA section 18 
the use of Thiophanate methyl on citrus for control of post-bloom fruit 
drop in Florida and Texas. This regulation extends a time-limited 
tolerance for combined residues of the fungicide thiophanate methyl and 
its metabolite, methyl 2-benzimidazoyl carbamate (MBC) in or on citrus 
at 0.5 ppm for an additional 6-month period. This tolerance will expire 
and is revoked on December 31, 2009. A time-limited tolerance was 
originally published in the Federal Register of September 12, 2002 (67 
FR 57748) (FRL-7196-5). The time-limited tolerance exemption was last 
extended on December 21, 2005 at 70 FR 75734.
    5. Thiophanate methyl. EPA has authorized under FIFRA section 18 
the use of thiophanate methyl on fruiting vegetables, including tomato 
for control of white mold in Florida, Virginia, and New Jersey. This 
regulation extends a time-limited tolerance for combined residues of 
the fungicide thiophanate methyl and its metabolite, methyl 2-
benzimidazoyl carbamate (MBC) in or on the fruiting vegetable crop 
group at 0.5 ppm for an additional 1-year period. This tolerance will 
expire and is revoked on December 31, 2009. A time-limited tolerance 
was originally published in the Federal Register of July 23, 2003 (68 
FR 43465) (FRL-7317-5). The time-limited tolerance exemption was last 
extended on December 21, 2005 at 70 FR 75734.
    6. Thiophanate methyl. EPA has authorized under FIFRA section 18 
the use of thiophanate methyl on mushroom spawn and growing substrate 
for control of green mold in California, Delaware, Maryland, Oregon, 
and Pennsylvania. This regulation extends a time-limited tolerance for 
combined residues of the fungicide thiophanate methyl and its 
metabolite, methyl 2-benzimidazoyl carbamate (MBC) in or on mushroom at 
0.01 ppm for an additional 1-year period. This tolerance will expire 
and is revoked on December 31, 2009. A time-limited tolerance was 
originally published in the Federal Register of February 5, 2003 (68 FR 
5847) (FRL-7285-9). The time-limited tolerance exemption was last 
extended on December 21, 2005 at 70 FR 75734.

III. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions 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, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not 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).
    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).

IV. 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: December 23, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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.

Sec.  180.110  [Amended]

0
2. In Sec.  180.110, in the table to paragraph (b), amend the entry for 
Walnut by revising the expiration date 12/31/08 to read 12/31/09.

Sec.  180.276  [Amended]

0
3. In Sec.  180.276, in the table to paragraph (b), amend the entry for 
Onion, dry bulb by revising the expiration date 12/31/08 to read 12/31/
09.

Sec.  180.371  [Amended]

0
4. In Sec.  180.371, in the table to paragraph (b), amend the entry for 
Citrus by revising the expiration date 6/30/09 to read 12/31/09 and the 
entries for Mushroom; and Vegetable, fruiting, group 8 by revising the 
expiration dates 12/31/08 to read 12/31/09.

Sec.  180.443  [Amended]

0
5. In Sec.  180.443, in the table to paragraph (b), amend the entries 
for Vegetable, foliage of legume, group 07 and Vegetable, legume, group 
06 by revising the expiration dates 6/30/09 to read 12/31/09.
[FR Doc. E9-31336 Filed 1-6-09; 8:45 am]

BILLING CODE 6560-50-S