[Federal Register: December 26, 2007 (Volume 72, Number 246)]
[Rules and Regulations]
[Page 72963-72965]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de07-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0545; FRL-8342-1]
Aspergillus Flavus AF36 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 AF36
on corn when applied/used before corn tasseling occurs. Arizona Cotton
Research and Protection Council 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 AF36. The
temporary tolerance exemption expires on December 31, 2011.
DATES: This regulation is effective December 26, 2007. Objections and
requests for hearings must be received on or before February 25, 2008,
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-2007-0545. 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 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 Federal
Insecticide, Fungicide, and Rodenticide Act (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 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-2007-0545 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 February 25, 2008.
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-2007-0545, by one of the following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
[[Page 72964]]
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 August 8, 2007 (72 FR 44521) (FRL-8139-
7), 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 7E7205) by Interregional Research Project Number 4 (IR-4),
Rutgers University, 500 College Road East, Suite 201W, Princeton, NJ
08540 on behalf of the Arizona Cotton Research and Protection Council,
3721 E. Wier Ave., Phoenix, AZ 85040. The petition requested that 40
CFR 180.1206 be amended by establishing a temporary exemption from the
requirement of a tolerance for residues of Aspergillus flavus AF36.
This notice included a summary of the petition prepared by the
petitioner IR-4, on behalf of the 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 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 unconditionally registered
microbial pesticide Aspergillus flavus AF36 for use on cotton has been
previously described in the final rule of the Federal Register of July
14, 2003 (68 FR 41535). Those health effects data were the basis for
establishing the exemption from tolerance of Aspergillus flavus AF36, a
non-aflatoxin-producing strain of Aspergillus flavus, on cotton in 40
CFR 180.1206. This exemption from tolerance was amended to include a
temporary exemption from tolerance for use of Aspergillus flavus AF36
on pistachio on May 23, 2007 (72 FR 28868) (FRL-8129-4). The database
supporting the current exemption from tolerance also supports the
proposed temporary exemption of this active ingredient on corn.
The pesticide is 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 pesticide and the
submitted pulmonary studies. This 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, Arizona Cotton Research and Protection Council, now
seeks to amend that exemption from tolerance of Aspergillus flavus AF36
on cotton, to include a temporary exemption from tolerance for residues
of the fungal active ingredient on corn. An Experimental Use Permit
(EUP), EPA Registration Number 71693-EUP-E, is proposed for three years
to treat corn fields by ground or aerial application before corn
tasseling occurs. The applicant also submitted additional data to
support the EUP. This data included information from the public
literature and from small field trials which indicate that there will
not be any incremental harm from the use of the pesticide during the
EUP. No further toxicological data are required for this temporary
exemption from the requirement of a tolerance for Aspergillus flavus
AF36 on corn.
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).
A. Dietary Exposure
1. Food. The aforesaid final rule for the exemption from tolerance
for residues of Aspergillus flavus AF 36 on cotton considered all
studies submitted by the applicant and found them to be acceptable.
Peeling or shucking of corn, washing, cooking, and processing of
treated commodities will mitigate against potential dietary exposure.
2. Drinking water exposure. Those data are also acceptable to
demonstrate that the proposed use of Aspergillus flavus AF36 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 U.S. 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
AF36 on corn. The pesticide is to be applied to agricultural sites not
in the proximity
[[Page 72965]]
of residential areas, schools, nursing homes, or daycares.
2. Inhalation exposure. For the same reasons non-occupational
inhalation exposure to AF36 is expected to be minimal to non-existent.
V. Cumulative Effects
Another non-aflatoxin-producing strain of Aspergillus flavus, NRRL
21882, is undergoing research trials on corn in Texas, but not in the
same areas to be treated during this EUP for AF36. Cumulative effects
of these strains are not expected to exceed the risk cup for the
registered Aspergillus flavus strains, AF36 and NRRL 21882.
Furthermore, these strains are expected to decrease the presence of
aflatoxin-producing colonies of the fungus on treated commodities and,
thus, decrease the risks posed by the potent liver carcinogen,
aflatoxin.
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 (see Federal Register
of July 14, 2003 (68 FR 41535), as cited in Unit III.).
VII. Other Considerations
A. Endocrine Disruptors
See Federal Register of July 14, 2003 (68 FR 41535), as cited in
Unit III.
B. Analytical Method(s)
See Federal Register of July 14, 2003 (68 FR 41535), as cited in
Unit III.
C. Codex Maximum Residue Level
There is no Codex Maximum Residue Level (MRL) for residues of
Aspergillus flavus AF36 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, 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: December 14, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
0
Therefore, 40 CFR part 180 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.
0
2. Section 180.1206 is amended by adding paragraph (c) to read as
follows:
Sec. 180.1206 Aspergillus flavus AF36; exemption from the requirement
of a tolerance.
* * * * *
(c) Apergillus flavus AF36 is temporarily exempt from the
requirement of a tolerance on corn when used in accordance with the
Experimental Use Permit 71693-EUP-2. This temporary exemption from
tolerance will expire December 31, 2011.
[FR Doc. E7-24979 Filed 12-21-07; 8:45 am]
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