[Federal Register: December 8, 2008 (Volume 73, Number 236)]
[Notices]
[Page 74483-74484]
[DOCID:fr08de08-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER01-1710-000; ER01-1710-001]

Mill Run Windpower, LLC; Notice of Issuance of Order

December 2, 2008.
    Mill Run Windpower, LLC (Mill Run) filed an application for market-
based rate authority, with an accompanying tariff. The proposed market-
based rate tariff provided for the sale of energy, capacity and
ancillary services at market-based rates. Mill Run also requested
waivers of various Commission regulations. In particular, Mill Run
requested that the Commission grant blanket approval under 18 CFR part
34 of all future issuances of securities and assumptions of liability
by Mill Run.
    On July 17, 2001, pursuant to delegated authority, the Director,
Division of Corporate Applications, granted the requests for blanket
approval under part 34 (Director's Order). On December 2, 2008,
pursuant to delegated authority, the Director, Division of Tariffs and
Market Development--West, issued an errata correcting several omissions
from the Director's Order (Errata). Among them,

the Errata stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Mill Run, should file a protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004). The Commission
encourages the electronic submission of protests using the FERC Online
link at http://www.ferc.gov.
    Notice is hereby given that the deadline for filing protests is
December 8, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Mill Run is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Mill Run, compatible with the
public interest, and is reasonably necessary or appropriate for such
purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Mill Run's issuance of securities or assumptions
of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the
docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-28925 Filed 12-5-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Notices]
[Pages 18614-18615]
[FR Doc No: 2016-07243]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1129-000]

VPI Enterprises, Inc.; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
VPI Enterprises, Inc.'s application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for

blanket authorization, under 18 CFR part 34, of future issuances of
securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 11, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 22, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-07243 Filed 3-30-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14287-14291]
[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<PHONE_NUMBER>.

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:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
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. 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<PHONE_NUMBER>.

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

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

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

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]
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