Document ID: EPA-HQ-OPP-2007-0158-0010
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Aspergillus flavus AF36; Amendment
Posted Date: 2012-03-09T05:00Z

[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14287-14291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5769]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0158; FRL-9341-5]

Aspergillus flavus AF36; Amendment to an Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing temporary tolerance 
exemption for Aspergillus flavus AF36 by establishing a permanent 
exemption from the requirement of a tolerance for residues of the 
microbial pesticide, Aspergillus flavus AF36, in or on pistachio when 
applied as an antifungal agent and used in accordance with good 
agricultural practices. On behalf of the Arizona Cotton Research and 
Protection Council, Interregional Research Project Number 4 submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting that EPA amend an existing temporary tolerance exemption for 
Aspergillus flavus AF36. This regulation eliminates the need to 
establish a maximum permissible level for residues of Aspergillus 
flavus AF36 under the FFDCA.

DATES: This regulation is effective March 9, 2012. Objections and 
requests for hearings must be received on or before May 8, 2012, 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 established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0158. All documents in the 
docket are listed in the docket index available at http://www.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 Office of Pesticide Programs (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: Jeannine Kausch, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8920; email 
address: kausch.jeannine@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

[[Page 14288]]

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. 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 get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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 objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 8, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, 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 online instructions for submitting comments.
     Mail: 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 Facility'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 April 20, 2011 (76 FR 22067) (FRL-8869-
7), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
1E7830) by Interregional Research Project Number 4 (IR-4), Rutgers 
University, 500 College Rd. East, Suite 201W, Princeton, NJ 08540 (on 
behalf of the Arizona Cotton Research and Protection Council, 3721 East 
Wier Ave., Phoenix, AZ 85040-2933). The petition requested that 40 CFR 
180.1206 be amended by establishing a permanent exemption from the 
requirement of a tolerance for residues of Aspergillus flavus AF36 in 
or on pistachio. This notice referenced a summary of the petition 
prepared by the petitioner, IR-4 (on behalf of the Arizona Cotton 
Research and Protection Council), which is available in the docket via 
http://www.regulations.gov. 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 FFDCA 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 
FFDCA 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 exemption 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, FFDCA section 408(b)(2)(D) requires that 
EPA 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 FFDCA section 408(b)(2)(D), EPA 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 also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    The nature and toxicological profile of Aspergillus flavus AF36, a 
non-aflatoxin-producing strain of Aspergillus flavus, was described 
extensively in the Federal Register of July 14, 2003 (68 FR 41535) 
(FRL-7311-6). ``Those health effects data were the basis for 
establishing the tolerance exemption for Aspergillus flavus AF36 in or 
on cotton (see the Federal Register of July 14, 2003) and corn (see the 
Federal Register of March 23, 2011 (76 FR 16297) (FRL-8868-7)) and 
their food/feed commodities and also for temporary tolerance exemptions 
for experimental use of Aspergillus flavus AF36 on pistachio (see the 
Federal Register of May 23, 2007 (72 FR 28868) (FRL-8129-4)) and on 
corn (see the Federal Register of December 26, 2007 (72 FR 72693) (FRL-
8342-1)).'' The petitioner has now requested that EPA establish a 
permanent exemption from the requirement of a tolerance for residues of 
Aspergillus flavus AF36 in or on pistachio by amending 40 CFR 180.1206. 
EPA reviewed the available data and information in support of this 
particular action.
    Aspergillus flavus AF36 is neither toxic nor infective via the oral 
and pulmonary routes. EPA has determined that AF36 is practically 
nontoxic for acute oral effects and slightly toxic for acute inhalation 
effects. This microbial 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. Based 
on the comprehensive toxicological evaluations set forth in earlier 
actions establishing tolerance

[[Page 14289]]

exemptions for Aspergillus flavus AF36 in or on cotton (see the Federal 
Register of July 14, 2003) and corn (see the Federal Register of March 
23, 2011) (also, see Ref. 1), EPA concludes that there are no 
toxicological endpoints of concern for Aspergillus flavus AF36.

IV. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 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 exposure. Current uses of Aspergillus flavus AF36 include 
use in or on cotton and corn. Use on pistachios was also permitted 
under Experimental Use Permit No. 71693-EUP-1, which expired on 
December 31, 2011. EPA previously evaluated exposure to residues of 
Aspergillus flavus AF36 through food, resulting from this microbial 
pesticide's use as an antifungal agent in or on cotton and corn, in the 
Federal Register of July 14, 2003 and March 23, 2011. Overall, EPA 
concluded that human food exposure was not expected with Aspergillus 
flavus AF36's cotton use and was expected (although likely not above 
Aspergillus flavus background levels) with Aspergillus flavus AF36's 
corn use.
    As a microbial pesticide for use on pistachio, Aspergillus flavus 
AF36 is intended for a single broadcast soil application from late May 
to early July. Once applied to pistachio and after exposure to 
moisture, Aspergillus flavus AF36 germinates, using the carrier upon 
which it is placed as a nutrient source, and displaces aflatoxin-
producing strains of Aspergillus flavus (Ref. 2). Further, multiple-
year studies, which monitored air and soil populations of Aspergillus 
flavus, including strain AF36, in untreated and treated cotton fields, 
demonstrated replacement of the naturally occurring aflatoxin-producing 
Aspergillus flavus with Aspergillus flavus AF36 without an increase in 
the total population of Aspergillus flavus beyond normal background 
levels (Refs. 3 and 4). Although residues from the use of pesticides 
containing Aspergillus flavus AF36 may be present on pistachios at the 
time of harvest, commodity processing procedures (e.g., roasting and 
shelling) may further reduce residues of Aspergillus flavus AF36 (Ref. 
5).
    Should this microbial pesticide be present on food as a result of 
the cotton, corn, and/or pistachio uses, the results of an acute oral 
toxicity and pathogenicity study (see Unit III. of the Federal Register 
of July 14, 2003, as well as Ref. 1) demonstrated that no toxicity, 
pathogenicity, and/or infectivity is likely to occur with any exposure 
level of Aspergillus flavus AF36 resulting from application as an 
antifungal agent in accordance with good agricultural practices.
    2. Drinking water exposure. Similar to the drinking water exposure 
scenarios described for Aspergillus flavus AF36's cotton and corn uses 
(see the Federal Register of July 14, 2003 and March 23, 2011) exposure 
to residues of this microbial pesticide in consumed drinking water, 
resulting from pesticidal use in or on pistachio, is possible but not 
likely to be greater than current/existing exposures to Aspergillus 
flavus strains, which are already present in the environment. Pistachio 
is grown in an arid environment, which minimizes the potential for 
transfer of Aspergillus flavus AF36 to surface or ground waters that 
may be used as sources of drinking water. Moreover, the pesticide is 
applied only once per growing season at a low rate to non-aquatic 
sites, and offsite movement is not anticipated since the pesticide is 
in a granular form. If Aspergillus flavus AF36 were to be transferred 
to surface or ground waters (e.g., through runoff) that are intended 
for eventual human consumption and directed to wastewater treatment 
systems or drinking water facilities, this soilborne fungus may not 
survive some of the conditions water is subjected to in such systems or 
facilities, including chlorination, pH adjustments, and filtration 
(Refs. 6 and 7).
    Should this microbial pesticide be present in drinking water (e.g., 
water not subject to treatment systems or facilities) as a result of 
the cotton, corn, and/or pistachio uses, the results of an acute oral 
toxicity and pathogenicity study (see Unit III. of the Federal Register 
of July 14, 2003, as well as Ref. 1) demonstrated that no toxicity, 
pathogenicity, and/or infectivity is likely to occur with any exposure 
level of Aspergillus flavus AF36 resulting from application as an 
antifungal agent in accordance with good agricultural practices.

B. Other Non-Occupational Exposure

    Non-occupational dermal and inhalation exposure is expected to be 
minimal to non-existent for the uses of Aspergillus flavus AF36 in or 
on cotton, corn, and pistachio. As described previously in the Federal 
Register of July 14, 2003 and March 23, 2011 for Aspergillus flavus 
AF36's cotton and corn uses, this antifungal agent is to be applied to 
agricultural sites and not in the proximity of residential areas, 
schools, nursing homes, or day care facilities. Additionally, the 
Aspergillus flavus AF36 product to be applied to cotton, corn, and 
pistachio is in a granular form, thereby minimizing drift even for 
application methods (e.g., aerial) that may be more likely to result in 
offsite pesticide movement and exposure.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance exemption, EPA 
consider ``available information concerning the cumulative effects of 
[a particular pesticide's] * * * residues and other substances that 
have a common mechanism of toxicity.''
    EPA has not found Aspergillus flavus AF36 to share a common 
mechanism of toxicity with any other substances, and Aspergillus flavus 
AF36 does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that Aspergillus flavus AF36 does not have a common 
mechanism of toxicity with other substances. Therefore, section 
408(b)(2)(D)(v) of FFDCA does not apply. For information regarding 
EPA's efforts to identify chemicals that may have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, EPA shall assess the available information about 
consumption patterns among infants and children, special susceptibility 
of infants and children to pesticide chemical residues, and the 
cumulative effects on infants and children of the residues and other 
substances with a common mechanism of toxicity. In addition, FFDCA 
section 408(b)(2)(C) provides that EPA shall apply an additional 
tenfold (10X) margin of exposure (safety) for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of exposure (safety) will 
be safe

[[Page 14290]]

for infants and children. This additional margin of exposure (safety) 
is commonly referred to as the Food Quality Protection Act Safety 
Factor. In applying this provision, EPA either retains the default 
value of 10X or uses a different additional safety factor when reliable 
data available to EPA support the choice of a different factor.
    In this instance, based on all the available information, EPA 
concludes that there are no threshold effects of concern to infants, 
children, or adults when Aspergillus flavus AF36 is used as labeled in 
accordance with good agricultural practices. As a result, EPA concludes 
that no additional margin of exposure (safety) is necessary to protect 
infants and children and that not adding any additional margin of 
exposure (safety) will be safe for infants and children.
    Moreover, based on the same data and EPA analysis as presented in 
this unit, the Agency is able to conclude that there is a reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposure to the residues of 
Aspergillus flavus AF36 when it is used as labeled and in accordance 
with good agricultural practices as an antifungal agent. Such exposure 
includes all anticipated dietary exposures and all other exposures for 
which there is reliable information. As discussed previously, there 
appears to be no potential for harm from this fungus in its use as an 
antifungal agent via dietary exposure since the microorganism is non-
toxic and non-pathogenic to animals and humans. EPA arrived at this 
conclusion based on the very low levels of mammalian toxicity for acute 
oral and pulmonary effects with no toxicity or infectivity at the doses 
tested (see Unit III. of this document).

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons stated in this document and because EPA is establishing an 
exemption from the requirement of a tolerance without any numerical 
limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. In this 
context, EPA considers the international maximum residue limits (MRLs) 
established by the Codex Alimentarius Commission (Codex), as required 
by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United 
Nations Food and Agriculture Organization/World Health Organization 
food standards program, and it is recognized as an international food 
safety standards-setting organization in trade agreements to which the 
United States is a party. EPA may establish a tolerance that is 
different from a Codex MRL; however, FFDCA section 408(b)(4) requires 
that EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for Aspergillus flavus AF36.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of Aspergillus flavus AF36. 
Therefore, the existing temporary tolerance exemption for Aspergillus 
flavus AF36 is amended by establishing a permanent exemption from the 
requirement of a tolerance for residues of Aspergillus flavus AF36 in 
or on pistachio when applied as an antifungal agent and used in 
accordance with good agricultural practices.

IX. References

1. U.S. EPA. 2003a. Aspergillus flavus AF36 Biopesticides 
Registration Action Document (Dated July 3, 2003). Available from 
http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/brad_006456.pdf.
2. U.S. EPA. 2011. Aspergillus flavus AF36 use on pistachio. 
Memorandum from J.V. Gagliardi, Ph.D. and J.L. Kough, Ph.D. to S. 
Bacchus dated September 29, 2011.
3. U.S. EPA. 2003b. Environmental Hazard Assessment for the 
Microbial Pesticide, Aspergillus flavus AF36 for Conditional 
Registration in Arizona and EUP Extension in Texas. Memorandum from 
G.S. Tomimatsu, Ph.D. and Z. Vaituzis, Ph.D. to S. Bacchus dated May 
16, 2003. Available from http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/006456/006456-2003-05-16a.pdf.
4. U.S. EPA. 2003c. BPPD Review of Soil and Air Monitoring Studies 
and Product Performance Testing (Efficacy) Submitted by USDA 
Southern Regional Research Center/IR-4 as a Condition of 
Registration and EUP Extension (Texas) for Aspergillus flavus AF36. 
Memorandum from G.S. Tomimatsu, Ph.D. and J. Kough, Ph.D. to S. 
Bacchus dated May 15, 2003. Available from http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/006456/006456-2003-05-15a.pdf.
5. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background 
for Residue Analysis of Microbial Pest Control Agents (OPPTS 
885.2000). Available from http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.
6. Centers for Disease Control and Prevention. 2009. Drinking 
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.
7. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment 
Systems. EPA 832-R-04-001. Available from http://www.epa.gov/npdes/pubs/primer.pdf.

X. Statutory and Executive Order Reviews

    This final rule amends a tolerance exemption under section 408(d) 
of FFDCA in response to a petition submitted to EPA. 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``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 amended on the basis of a 
petition under FFDCA section 408(d), such as the tolerance exemption 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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

[[Page 14291]]

the Federal Government and Indian tribes. Thus, EPA 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 9, 
2000), do not apply to this final rule. In addition, this final 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 EPA 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).

XI. 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: February 29, 2012.
Keith A. Matthews,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    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 revising paragraph (b) to read as 
follows:

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

* * * * *
    (b) An exemption from the requirement of a tolerance is established 
for residues of Aspergillus flavus AF36 in or on pistachio when applied 
as an antifungal agent and used in accordance with good agricultural 
practices.
* * * * *
[FR Doc. 2012-5769 Filed 3-8-12; 8:45 am]
BILLING CODE 6560-50-P