Document ID: EPA-HQ-OPP-2007-0158-0003
Agency: epa
Document Type: Rule
Title: Aspergillus flavus AF36 on Pistachio; Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2007-05-23T04:00Z

[Federal Register: May 23, 2007 (Volume 72, Number 99)]
[Rules and Regulations]               
[Page 28868-28871]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my07-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0158; FRL-8129-4]

 
Aspergillus flavus AF36 on Pistachio; 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 Aspergillus flavus AF36 on 
pistachio when applied/used to reduce aflatoxin-producing Aspergillus 
flavus. 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 
East Wier Avenue Phoenix, Arizona 85040-2933 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 May 14, 2010.

DATES: This regulation is effective May 23, 2007. Objections and 
requests for hearings must be received on or before June 22, 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-2007-0158. 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. 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

[[Page 28869]]

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-2007-0158 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 July 23, 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-2007-0158, 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'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) (FRL-8117-
4), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 6E7118) 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 85040-2933. The petition requested that 
40 CFR part 180 be amended by establishing a temporary exemption from 
the requirement of a tolerance for residues of Aspergillus flavus AF36 
on pistachio. This notice included a summary of the petition prepared 
by the petitioner IR-4, on behalf of the Arizona Cotton Research and 
Protection Council. One comment received in response to the notice of 
filing suggested that the area should be notified of the proposed 
application of the pesticide. In this respect, a Federal Register 
Notice of the receipt of the application for the Experimental Use 
Permit was published in the Federal Register on March 9, 2007 (72 FR-
10751) (FRL-8117-6). Another announcement, regarding the filing of the 
pesticide petition discussed herein, was published in the Federal 
Register on March 21, 2007 (72 FR 13277) (FRL-8117-4).
    Section 408(c)(2)(A)(i) of the 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 the 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 the 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 the 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 conditionally registered microbial 
pesticide, Aspergillus flavus AF36 has been previously described in the 
final rule of the Federal Register of July 14, 2003 (68 FR 41535) (FRL-
7311-6). The exemption from tolerance of Aspergillus flavus AF36, a 
non-aflatoxin-producing strain of Aspergillus flavus, on cotton was 
established in 40 CFR Sec. 180.1206. The database supporting that 
exemption from tolerance also supports the proposed temporary exemption 
of this active ingredient on pistachio. The 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

[[Page 28870]]

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, Texas and California without any reports of adverse dermal 
irritation or hypersensitivity effects.
    The petitioner 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 
pistachio. An Experimental Use Permit, EPA Registration Number 71693-
EUP-1, is proposed for three years to treat 3,000 acre pistachio trees 
per year by ground application. Treatment of a total of 9,000 acres 
over three years in 2007, 2008, and 2009, will utilize a total of 
approximately 0.72 pound of the active ingredient, Aspergillus flavus 
AF36. No further toxicological data are required for this temporary 
exemption from the requirement of a tolerance for Aspergillus flavus 
AF36 on pistachio.

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 AF 36 on cotton considered all 
studies submitted by the applicant and found them to be acceptable. 
Roasting of pistachio nuts and other post harvest agricultural 
practices, such as treatment with phosphine, are expected to further 
reduce any aflatoxin contamination of pistachio nuts.
    2. Drinking water exposure. Those data are also acceptable to 
demonstrate that the proposed use of Aspergillus flavus AF36 on 
pistachio 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 pistachio. 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 AF36 is expected to be minimal to non-existent.

V. Cumulative Effects

    Another non-aflatoxin-producing strain of Aspergillus flavus, NRRL 
21882 is registered, but not for use on pistachio. 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 9 (see Federal 
Register, July 14, 2003, as cited in Unit III.)

VII. Other Considerations

A. Endocrine Disruptors

    See Federal Register, July 14, 2003, cited in Unit III.

B. Analytical Method(s)

    See Federal Register, July 14, 2003, cited in Unit III.

C. Codex Maximum Residue Level

    There is no Codex Maximum Residue Level (MRL) for residues of 
Aspergillus flavus AF36 on pistachio.

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) (Pub. L. 
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), Pub. L. 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

[[Page 28871]]

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 14, 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 180.1206 is amended by designating the existing text as 
paragraph (a) and by adding paragraph (b) to read as follows:

Sec.  180.1206  Aspergillus flavus AF36 on pistachio; exemption from 
the requirement of a tolerance.

    (a) * * *
    (b) Apergillus flavus AF36 is temporarily exempt from the 
requirement of a tolerance on pistachio when used in accordance with 
the Experimental Use Permit 71693-EUP-1. This temporary exemption from 
tolerance will expire on May 14, 2010.
[FR Doc. E7-9729 Filed 5-22-07; 8:45 am]

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