[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Rules and Regulations]
[Page 27460-27463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my07-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0160; FRL-8130-6]
Aspergillus flavus NRRL 21882 on Corn; Temporary Exemption From
the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of the Aspergillus flavus NRRL
21882 on corn when applied aerially once per season at the first sign
of corn tasseling to reduce aflatoxin-producing Aspergillus flavus.
Acta Group, 1203 Nineteenth St., NW., Suite 300, Washington, DC 20036-
2401 on behalf of Circle One Global, Inc. One Arthur St. P.O. Box 28,
Shellman, GA 39886-0028 submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting the temporary tolerance
exemption. This regulation eliminates the need to establish a maximum
permissible level for residues of Aspergillus flavus NRRL 21882. The
temporary tolerance exemption expires on May 2, 2009.
DATES: This regulation is effective May 16, 2007. Objections and
requests for hearings must be received on or before June 15, 2007, 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-2007-0160. 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 web site 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.
[[Page 27461]]
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Section 5 of FIFRA
and the regulations promulgated to carry out that provision of FIFRA
(40 CFR part 172). 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 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 the FFDCA, as amended by the 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-2007-0160 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 July 16, 2007.
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-2007-0160, 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
In the Federal Register of March 21, 2007 (72 FR 13277-13279) (FRL-
8117-4), 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 6F7121) by Acta Group, 1203 Nineteenth St., NW., Suite
300, Washington, DC 20036-2401 on behalf of Circle One Global, Inc.
P.O. Box 28, Shellman, GA 39886-0028. The petition requested that 40
CFR part 180 be amended to include a temporary exemption from the
requirement of a tolerance for residues of Aspergillus flavus NRRL
21882 on corn. This notice included a summary of the petition prepared
by the petitioner Acta Group, on behalf of Circle One Global, Inc. No
comments were received in response to the Federal Register Notice.
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), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), 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
[[Page 27462]]
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.
Aspergillus flavus NRRL 21882 is a non-aflatoxin-producing fungal
active ingredient that will be used to displace the ubiquitous
Aspergillus flavus group of microbes, many of which can produce
aflatoxin, a potent carcinogen. The toxicological profile of this
conditionally registered active ingredient has been previously
described in the final rule of the Federal Register of June 30, 2004,
(69 FR 39341) (FRL-7364-2). On the basis of those studies, the
exemption from tolerance of Aspergillus flavus NRRL 21882, a non-
aflatoxin-producing strain of Aspergillus flavus, on peanuts was
established in 40 CFR 180.1254.
The acute toxicology oral studies placed Aspergillus flavus NRRL
21882 in Toxicity Category IV. This active ingredient was not toxic,
infective or pathogenic to mammals on the basis of acute oral,
pulmonary and intraperitoneal studies. That database supporting the
exemption from tolerance on peanut also supports the proposed temporary
exemption of this active ingredient on corn. For a summary of the
studies and discussions of dietary and non-dietary, non-occupational
dermal and inhalation exposures, as well as aggregate and cumulative,
exposures, and potential endocrine effects refer to the aforesaid June
30, 2004 final rule. All studies met the safety standards of the Food
Quality Protection Act of 1996. This pesticide has been used for more
than a decade in experimental laboratory and field trials without any
reports of adverse dermal irritation or hypersensitivity effects.
The petitioner is now requesting that those studies be also used as
the basis to amend the tolerance exemption to include a temporary
exemption from tolerance for Aspergillus flavus NRRL 21882 on corn
during the Experimental Use Permit with EPA Registration Number (EPA
Reg. No.) 75624-EUP-2. The proposed two-year, non-crop destruct
Experimental Use Permit is for treatment of approximately 6,000 acres
of corn grown for grain in Texas at ten or 20 pounds of the End-use
Product (EP) aflaguard\R\ per acre.
The Agency has determined that the studies do support the proposed
exemption from tolerance of Aspergillus flavus NRRL 21882 on corn.
Summaries of the rationales for this determination may be found in the
aforesaid Federal Register Final Rule of June 30, 2004. No further
toxicological data are required for this temporary exemption from the
requirement of a tolerance for Aspergillus flavus NRRL 21882 on corn.
The applicant must, however, report any incidents of hypersensitivity,
or any other adverse effects to comply with the requirements of Section
6(a)(2). Efficacy data to demonstrate that the pesticide does reduce
aflatoxin-producing Aspergillus flavus colonies and, concomitantly,
aflatoxin in corn, are required as part of the Experimental Use Permit.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the 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).
A. Dietary Exposure
1. Food. The aforesaid final rule for the exemption from tolerance
for residues of Aspergillus flavus NRRL 21882 on peanut considered all
studies submitted by the applicant and found them to be acceptable.
2. Drinking water exposure. Those data are also acceptable to
demonstrate that the proposed use of Aspergillus flavus NRRL 21882 on
corn will not harm the U.S. adult, infant and children population from
dietary exposure, including food, and drinking water. Percolation
through the soil and municipal treatment of drinking water are expected
to preclude exposure of the US population, infants and children to
residues of the pesticide.
B. Other Non-Occupational Exposure
1. Dermal exposure. Dermal non-occupational exposure is expected to
be minimal to non-existent for the proposed use of Aspergillus flavus
NRRL 21882 on corn. The pesticide is to be applied to agricultural
sites not in the proximity of residential areas, schools, nursing homes
or daycares.
2. Inhalation exposure. For the same reasons non-occupational
inhalation exposure to Aspergillus flavus NRRL 21882 is expected to be
minimal to non-existent.
V. Cumulative Effects
Another non-aflatoxin-producing strain of Aspergillus flavus, AF36,
is registered, but not for use on corn. Cumulative effects of these
strains are not expected to exceed the risk cup for the registered
Aspergillus flavus strains, AF36 and NRRL 21882.
VI. Determination of Safety for U.S. Population, Infants and Children
Based on the previously evaluated data, it is not necessary to use
a safety factor to determine safety to children June 30, 2004, (69 FR
39341).
VII. Other Considerations
A. Endocrine Disruptors
See Federal Register, June 30, 2004, (69 FR 39341).
B. Analytical Method
See Federal Register, June 30, 2004, (69 FR 39341).
C. Codex Maximum Residue Level
There is no Codex Maximum Residue Level (MRL) for residues of
Aspergillus flavus NRRL 21882 on corn.
VIII. Statutory and Executive Order Reviews
This final rule establishes 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 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,
[[Page 27463]]
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).
IX. 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 4, 2007.
Janet L. Andersen,
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
0
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 180.1254 is amended by designating the existing text as
paragraph (a) and by adding paragraph (b) to read as follows:
Sec. 180.1254 Aspergillus flavus NRRL 21882; exemption from
requirement of a tolerance.
(a) * * *
(b) Aspergillus flavus NRRL 21882 is temporarily exempt from the
requirement of a tolerance on corn when used in accordance with the
Experimental Use Permit 75624-EUP-2. This temporary exemption from
tolerance will expire on May 2, 2009.
[FR Doc. E7-9427 Filed 5-15-07; 8:45 am]
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