[Federal Register: June 3, 2009 (Volume 74, Number 105)]
[Rules and Regulations]
[Page 26543-26546]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn09-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0158; FRL-8416-7]
Aspergillus flavus AF36 on Pistachio; Extension of Temporary
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the temporary exemption from the
requirement of a tolerance for residues of the Aspergillus flavus AF36
(A. flavus AF36) on pistachio when applied/used
[[Page 26544]]
as an antifungal agent to displace aflatoxin-producing fungi.
Interregional Research Project Number 4 (IR-4), on behalf of the
Arizona Cotton Research and Protection Council, submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
the temporary tolerance exemption be amended. The amendment extends the
expiration date to December 31, 2011.
DATES: This regulation is effective June 3, 2009. Objections and
requests for hearings must be received on or before August 3, 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-2007-0158. 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: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail
address: bacchus.shanaz@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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents 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 e-CFR site at http://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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. 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-2007-0158 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 August 3, 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-2007-0158, 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 and Statutory Findings
In the Federal Register of March 16, 2009 (74 FR 11100) (FRL-8405-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8E7461) by IR-4, Rutgers University, 500 College Road
East, Suite 201W., Princeton, NJ 08540, on behalf of the Arizona Cotton
Research and Protection Council, 3721 East Weir Ave., Phoenix, AZ
85040-2933. The petition proposes to amend a temporary exemption from
the requirement of a tolerance in 40 CFR 180.1206(b) for residues of
the non-aflatoxin-producing microbial antifungal agent, A. flavus AF36,
in or on pistachio.
This docket included a summary of the petition prepared by the
petitioner IR-4 and Arizona Cotton Research and Protection Council.
There were no comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a
[[Page 26545]]
tolerance, EPA must take into account the factors set forth in section
408(b)(2)(C) of FFDCA, which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue....''
Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
The toxicological profile of the microbial pesticide, A. flavus
AF36 has been previously described in the final rule of the Federal
Register issue of July 14, 2003 (68 FR 41535) (FRL-7311-6). The
exemption from tolerance of A. flavus AF36, a non-aflatoxin-producing
strain of Aspergillus flavus, on cotton was established in 40 CFR
180.1206. The database supporting that exemption from tolerance also
supports the temporary exemption of this active ingredient on pistachio
in 40 CFR 180.1206(b). See the Federal Register issue of May 23, 2007
(72 FR 28868) (FRL-8129-4).
The microbial pesticide was neither toxic nor infective via the
oral and pulmonary routes. It was placed in Toxicity Category IV for
acute oral effects. The Toxicity Category III designation for acute
inhalation effects is based on the granular nature of the microbial
pesticide and the submitted pulmonary studies. This microbial pesticide
has been used for more than a decade in experimental laboratory and
field trials and in agricultural practice on cotton in Arizona,
California, and Texas without any reports of adverse dermal irritation
or hypersensitivity effects.
The petitioner now seeks to amend the temporary exemption from the
requirement of a tolerance for A. flavus AF36 on pistachio in
accordance with the Experimental Use Permit (EUP), EPA File Symbol
71693-EUP-1, published in the Federal Register issue of May 23, 2007
(72 FR 28971) (FRL-8128-8) and to extend it to December 31, 2011.
No further toxicological data are required for this amended
temporary exemption from the requirement of a tolerance for A. flavus
AF36 on pistachio.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
For aggregate dietary and other non-occupational exposure and
cumulative effects, the Agency continues to rely on its previous
assessments published in the Federal Register, since the extension will
not change these exposures and risks. See the previously published July
14, 2003 and May 23, 2007 Federal Register documents cited in Unit III.
V. Determination of Safety for U.S. Population, Infants and Children
The Agency also relies on the previous assessments published in the
July 14, 2003 and May 23, 2007 Federal Register documents cited in Unit
III. to determine that there is reasonable certainty that no harm will
result from aggregate exposures to residues of the antifungal agent A.
flavus AF36. Because there are no threshold effects of concern to
infants, children and adults when A. flavus AF36 is used as labeled,
the provision requiring an additional margin of safety does not apply.
As a result, EPA has not used a margin of exposure (safety) approach to
assess the safety of A. flavus AF36.
VI. Other Considerations
A. Analytical Methods and Endocrine Disruptors
The Agency continues to rely on its assessment for endocrine
disruptors and analytical methods in the previously published July 14,
2003 Federal Register document cited in Unit III.
B. Codex Maximum Residue Level
There is no Codex Maximum Residue Level (MRL) for residues of A.
flavus AF36 on pistachio.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance or exemption from a
tolerance 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 final rule has been exempted from review under
Executive Order 12866, this final 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)
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 temporary
tolerance exemption 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
[[Page 26546]]
Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 9, 2000) do not apply to this final rule. In
addition, this final 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).
VIII. 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: May 20, 2009.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.1206(b) is revised to read as follows:
Sec. 180.1206 Aspergillus flavus AF36, exemption from the requirement
of a tolerance.
* * * * *
(b) Aspergillus flavus AF36 is temporarily exempt from the
requirement of a tolerance on pistachio when used in accordance with
the Experimental Use Permit, EPA File Symbol 71693-EUP-1. This
temporary exemption from tolerance expires on December 31, 2011.
* * * * *
[FR Doc. E9-12788 Filed 6-2-09; 8:45 am]
BILLING CODE 6560-50-S