Document ID: EPA-HQ-OPP-2007-0160-0003
Agency: epa
Document Type: Rule
Title: Aspergillus flavus NRRL 21882 on Corn; Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2007-05-16T04:00Z

[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.

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.

0
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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