Document ID: EPA-HQ-OPP-2007-0545-0003
Agency: epa
Document Type: Rule
Title: Aspergillus Flavus AF36 on Corn; Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2007-12-26T05:00Z

[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]

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. 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]

BILLING CODE 6560-50-S