[Federal Register: June 3, 2009 (Volume 74, Number 105)]
[Notices]
[Page 26693-26695]
[DOCID:fr03jn09-63]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0322; FRL-8420-3]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

 AGENCY: Environmental Protection Agency (EPA).

 ACTION: Notice.

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 SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review The Use of Structure Activity Relationships of
Estrogen Binding Affinity to Support Prioritization of Pesticide Inert
Ingredients and Antimicrobial Pesticides for Screening and Testing.

DATES: The meeting will be held on August 25-27, 2009, from 9 a.m. to
approximately 5:30 p.m.
    Comments. The Agency encourages that written comments be submitted
by August 17, 2009, and requests for oral comments be submitted by
August 20, 2009. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after August 17, 2009, should contact the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT. For additional instructions, see Unit I.C. of the
SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before June 17,
2009
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0322, 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 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>.
    Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2009-0322. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT to obtain special instructions before
submitting your comments. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: 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., 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 either 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 hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.

 FOR FURTHER INFORMATION CONTACT: Sharlene Matten, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
addresses<EMAIL_ADDRESS>
 SUPPLEMENTARY INFORMATION:

 I. General Information

 A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities

may also be interested, the Agency has not attempted to describe all
the specific entities that may be affected by this action. If you have
any questions regarding the applicability of this action to a
particular entity, consult the DFO listed under FOR FURTHER INFORMATION
CONTACT.

 B. What Should I Consider as I Prepare My Comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     2. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

 C. How May I Participate in This Meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2009-0322 in the subject line
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than August
17, 2009, to provide FIFRA SAP the time necessary to consider and
review the written comments. Written comments are accepted until the
date of the meeting, but anyone submitting written comments after
August 17, 2009, should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments at the meeting
should bring 30 copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than August 20, 2009, in order to be included on the meeting
agenda. Requests to present oral comments will be accepted until the
date of the meeting and, to the extent that time permits, the Chair of
FIFRA SAP may permit the presentation of oral comments at the meeting
by interested persons who have not previously requested time. The
request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment (e.g., overhead
projector, 35 mm projector, chalkboard). Oral comments before FIFRA SAP
are limited to approximately 5 minutes unless prior arrangements have
been made. In addition, each speaker should bring 30 copies of his or
her comments and presentation slides for distribution to the FIFRA SAP
at the meeting.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of FIFRA SAP
for this meeting. As part of a broader process for developing a pool of
candidates for each meeting, FIFRA SAP staff routinely solicits the
stakeholder community for nominations of prospective candidates for
service as ad hoc members of FIFRA SAP. Any interested person or
organization may nominate qualified individuals to be considered as
prospective candidates for a specific meeting. Individuals nominated
for this meeting should have expertise in one or more of the following
areas: In Vitro Models of Receptor Binding (e.g., Estrogen) and Gene
Activation, Expert Systems and SAR Modeling, and Use of Expert Systems
in Prioritization Processes for Toxicity Testing Programs. Nominees
should be scientists who have sufficient professional qualifications,
including training and experience, to be capable of providing expert
comments on the scientific issues for this meeting. Nominees should be
identified by name, occupation, position, address, and telephone
number. Nominations should be provided to the DFO listed under FOR
FURTHER INFORMATION CONTACT on or before June 17, 2009. The Agency will
consider all nominations of prospective candidates for this meeting
that are received on or before this date. However, final selection of
ad hoc members for this meeting is a discretionary function of the
Agency.
     The selection of scientists to serve on FIFRA SAP is based on the
function of the panel and the expertise needed to address the Agency's
charge to the panel. No interested scientists shall be ineligible to
serve by reason of their membership on any other advisory committee to
a Federal department or agency or their employment by a Federal
department or agency except the EPA. Other factors considered during
the selection process include availability of the potential panel
member to fully participate in the panel's reviews, absence of any
conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of lack
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on FIFRA SAP. Numerous qualified
candidates are identified for each panel. Therefore, selection
decisions involve carefully weighing a number of factors including the
candidates' areas of expertise and professional qualifications and
achieving an overall balance of different scientific perspectives on
the panel. In order to have the collective breadth of experience needed
to address the Agency's charge for this meeting, the Agency anticipates
selecting approximately 10-12 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by EPA in 5 CFR
part 6401. In anticipation of this requirement, prospective candidates
for service on the FIFRA SAP will be asked to submit confidential
financial information which shall fully disclose, among other financial
interests, the candidate's employment, stocks and bonds, and where
applicable, sources of research support. EPA will evaluate the
candidates financial disclosure form to assess whether there are
financial conflicts of interest, appearance of a lack of impartiality
or any prior involvement with the development of the documents under
consideration (including previous scientific peer review) before the
candidate is considered further for service on FIFRA SAP. Those who are
selected from the pool of prospective candidates will be asked to
attend the public meetings and to participate in the discussion of key
issues and assumptions at these meetings. In addition, they will be
asked to review and to help finalize the meeting minutes. The list of
FIFRA SAP members participating at this meeting will be posted on the
FIFRA SAP website at http://epa.gov/scipoly/sap or may be obtained from
the OPP

Regulatory Public Docket at http://www.regulations.gov.

 II. Background

 A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and
is structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. FIFRA SAP is a Federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act. FIFRA SAP is composed of a permanent
panel consisting of seven members who are appointed by the EPA
Administrator from nominees provided by the National Institutes of
Health and the National Science Foundation. FIFRA, as amended by FQPA,
established a Science Review Board consisting of at least 60 scientists
who are available to the SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, FIFRA SAP provides
comments, evaluations and recommendations to improve the effectiveness
and quality of analyses made by Agency scientists. Members of FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency.

 B. Public Meeting

    The Office of Pesticide Programs has a number of ongoing activities
to broaden the suite of computer-based methods to better predict
potential hazards and improve the effectiveness of risk assessment and
risk management by focusing the generation of new data on likely risks
of concern. The use of structure-activity relationships (SARs) in early
hazard identification is one such cost effective prioritization tool
that can guide the systematic collection of key test data. EPA is
required to screen all pesticide chemicals, which includes active
ingredients and other (``inert'') ingredients for potential endocrine
disruption (ED). The Agency must prioritize hundreds of chemicals for
ED screening and testing in biologically complex and resource intensive
assays. This FIFRA SAP review will be focused on an SAR approach that
was developed for pesticide inert ingredients and antimicrobial
pesticides to help prioritize candidate chemicals for the Tier 1
Endocrine Disruptor Screening Program specific to an estrogen-mediated
toxicity pathway. A particularly challenging issue is the development
of prioritization techniques for chemicals, such as inert ingredients
and some antimicrobial active ingredients that have minimal existing
toxicological information. This SAR/Rule-Based Expert System for
predicting estrogen receptor (ER) binding affinity is based on data
derived from two in vitro assays: one optimized to measure the
potential of chemicals to bind rainbow trout estrogen receptors (rtER),
and a second that measures gene activation through production of
vitellogenin. The SAP will be asked to comment on various aspects of
the SAR/Rule-Based Expert System including transparency of the
approach, biological endpoint definition, mechanistic interpretation,
and model's applicability domain.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc
members for this meeting), and the meeting agenda will be available by
August 10, 2009. In addition, the Agency may provide additional
background documents as the materials become available. You may obtain
electronic copies of these documents, and certain other related
documents that might be available electronically, at http://
www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/
scipoly/sap.
    FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted on the FIFRA SAP website or may be
obtained from the OPP Regulatory Public Docket at http://
www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: May 27, 2009.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. E9-12923 Filed 6-2-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Page 63962]
[FR Doc No: 2018-26851]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-034, OMB Control No. 3235-0034]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 17f-2(a)

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in the Rule
17f-2(a), (17 CFR 240.17f-2(a)), under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.).
    Rule 17f-2(a) (Fingerprinting Requirements for Securities
Professionals) requires that securities professionals be fingerprinted.
This requirement serves to identify security- risk personnel, to allow
an employer to make fully informed employment decisions, and to deter
possible wrongdoers from seeking employment in the securities industry.
Partners, directors, officers, and employees of exchanges, brokers,
dealers, transfer agents, and clearing agencies are included.
    The Commission staff estimates that approximately 4,480 respondents
will submit an aggregate total 289,780 new fingerprint cards each year
or approximately 65 fingerprint cards per year per registrant. The
staff estimates that the average number of hours necessary to complete
a fingerprint card is one-half hour. Thus, the total estimated annual
burden is 144,890 hours for all respondents (289,780 times one-half
hour). The average internal labor cost of compliance per hour is
approximately $283. Therefore, the total estimated annual internal
labor cost of compliance for all respondents is $41,003,870 (144,890
times $283).
    This rule does not involve the collection of confidential
information.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Charles Riddle, Acting Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Candace Kenner, 100 F Street NE, Washington, DC 20549, or by sending an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: December 4, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-26851 Filed 12-11-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Rules and Regulations]
[Page 48402-48408]
[DOCID:fr23se09-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0810; FRL-8434-2]

Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
spinosad in or on date and pomegranate, and additionally increases
established tolerances in or on almond hulls; tree nut, group 14; and
pistachio. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective September 23, 2009. Objections and
requests for hearings must be received on or before November 23, 2009,
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-2008-0810. 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 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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail 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 those
engaged in the following activities:
     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 to
provide 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0810 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 as required by 40 CFR part 178
on or before November 23, 2009.
    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 this copy, identified by docket ID number
EPA-HQ-OPP-2008-0810, 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 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. Petition for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73648) (FRL-
8391-3), 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 petition (PP
8E7445) by IR-4, 500 College Rd. East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.495 be amended by
establishing tolerances for residues of the insecticide, spinosad, a
fermentation product of Saccharopolyspora spinosa, consisting of two
related active ingredients: Spinosyn A (Factor A; CAS131929-
60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-
13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-

2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on pomegranate at
0.3 parts per million (ppm) and date at 0.1 ppm. The petition
additionally requested an increase in the existing tolerances for
residues of spinosad in or on tree nut, group 14 and pistachio from
0.02 to 0.08 ppm; and almond, hulls from 2.0 to 9.0 ppm. That notice
referenced a summary of the petition prepared on behalf of IR-4 by Dow
AgroSciences, LLC, the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance levels for almond hulls; tree nut, group
14; and pistachio. The reason for these changes is explained in Unit
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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.
Section 408(b)(2)(C) of FFDCA requires 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.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of spinosad on almond, hulls at 19 ppm; tree
nut, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at 0.10 ppm; and
pomegranate at 0.30 ppm. EPA's assessment of exposures and risks
associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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 existing spinosad data indicate that it possesses low acute
toxicity via the oral, dermal, and inhalation routes of exposure. It is
not a dermal irritant, dermal sensitizer or eye irritant. No dermal
toxicity was seen at the limit dose in a 21-day dermal toxicity study
in rabbits.
    In mice, rats, and dogs, the target organs appeared to be the
liver, kidney, spleen, heart, thyroid, and bone marrow (anemia). In the
mouse subchronic toxicity study, increased vacuolation of cells was
noted in the lymphoid organs, liver, kidney, stomach, female
reproductive tract and epididymis. A similar effect was seen in the
heart, lung, pancreas, adrenal cortex, bone marrow, tongue, pituitary
gland, and anemia but to a less severe degree. The rat subchronic
toxicity study showed evidence of thyroid follicle epithelial cell
vacuolation, anemia, multifocal hepatocellular granuloma,
cardiomyopathy, and splenic histiocytosis. Microscopic changes in a
variety of tissues, anemia and possible liver damage were seen in the
dog subchronic toxicity study. Additionally, long-term dietary
administration of spinosad resulted in increases in serum alanine
aminotransferase, aspartate aminotransferase and triglyceride levels.
    Spinosad is classified as ``not likely to be carcinogenic to
humans'' based on the lack of evidence for carcinogenicity in mice and
rats. No evidence of neurotoxicity was seen in any of the submitted
studies, including the acute and subchronic neurotoxicity studies in
rats. Spinosad is negative for mutagenicity in various mutagenicity
assays.
    No developmental effects were seen in the rat and rabbit
developmental toxicity studies. In a 2-generation reproduction study in
rats, decreased litter size, survival and body weights were observed in
the presence of maternal toxicity (deaths) at the highest dose tested
(HDT). In addition, male rats exhibited chronic active inflammation of
the prostate gland.
    Specific information on the studies received and the nature of the
adverse effects caused by spinosad as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document ``Spinosad and Spinetoram. Human-
Health Risk Assessment for Application of Spinosad to Date and
Pomegranate and Spinetoram to Pineapple, Date, Pomegranate, Hops, and
Spices (Crop Subgroup 19B, except black pepper)'' at pages 44-48 in
docket ID number EPA-HQ-OPP-2008-0810.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    The Agency has concluded that spinosad should be considered
toxicologically identical to another pesticide, spinetoram. This
conclusion

is based on the following: (1) Spinetoram and spinosad are large
molecules with nearly identical structures; and (2) the toxicological
profiles for each are similar (generalized systemic toxicity) with
similar doses and endpoints chosen for human health risk assessment.
Spinosad and spinetoram should be considered toxicologically identical
in the same manner that metabolites are generally considered
toxicologically identical to the parent.
    Although, as stated above, the doses and endpoints for spinosad and
spinetoram are similar, they are not identical due to variations in
dosing levels used in the spinetoram and spinosad toxicological
studies. EPA compared the spinosad and spinetoram doses and endpoints
for each exposure scenario and selected the lower of the two doses for
use in human risk assessment.
    A summary of the toxicological endpoints for spinosad and
spinetoram used for human risk assessment can be found at http://
www.regulations.gov in the document ``Spinosad and Spinetoram. Human-
Health Risk Assessment for Application of Spinosad to Date and
Pomegranate and Spinetoram to Pineapple, Date, Pomegranate, Hops, and
Spices (Crop Subgroup 19B, except black pepper)'' at pages 8 and 21 in
docket ID number EPA-HQ-OPP-2008-0810.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spinosad and spinetoram, EPA considered exposure under the
petitioned-for tolerances as well as all existing spinosad and
spinetoram tolerances in 40 CFR 180.495 and 180.635, respectively. EPA
assessed dietary exposures from spinosad and spinetoram in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for spinosad and spinetoram;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. Spinosad and spinetoram are considered to be
toxicologically equivalent. However, as both products control the same
pest species, EPA concluded that it would overstate exposure to assume
that residues of both chemicals would appear on the same crop.
Therefore, the Agency aggregated exposure from residues of spinosad and
spinetoram by assuming that spinosad residues would be present in all
commodities, because side-by-side spinosad and spinetoram residue data
indicated that spinetoram residues were less than or equal to spinosad
residues.
    In conducting the chronic dietary exposure assessment EPA used the
food consumption data from the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 Continuing Survey of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed 100 percent crop
treated (PCT) for all food crop commodities; used average field trial
residues for apple, Brassica leafy vegetables, citrus, fruiting
vegetables, herbs, banana, and strawberry; used tolerance-level
residues for the remaining food crop commodities; and used Dietary
Exposure Evaluation Model (DEEM) default processing factors for all
commodities excluding orange juice, field corn (meal, starch, flour,
and oil), grape juice and wheat (flour and germ), where the results
from processing studies were used. Residues in livestock were refined
through the incorporation of a refined dietary burden (average feed
crop residues and combined spinosad and spinetoram PCT estimates) and
through the incorporation of average residues from the feeding and
dermal magnitude of the residue studies.
    iii. Cancer. Based on the lack of evidence of carcinogenicity in
rats and mice, EPA has classified spinosad as ``not likely to be
carcinogenic to humans;'' therefore, a quantitative exposure assessment
to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition A: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition B: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition C: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    EPA assumed 100 PCT for all food crop commodities. For certain feed
crop commodities, the Agency used combined spinosad and spinetoram
projected PCT (PPCT) information to calculate beef and dairy cattle
burdens as follows:
    Sweet corn forage (39%); leaves of root and tuber vegetables (50%);
sorghum grain (5%); and soybean seed meal (5%).
    Spinetoram is a recently registered pesticide. EPA estimates an
upper bound of PPCT for a new pesticide use by assuming that its actual
PCT during the initial 5 years of use on a specific use site will not
exceed the recent PCT of the market leader (i.e., the one with the
greatest PCT) on that site. EPA calls this the market leader PPCT
estimate. In this specific case, the new use to be estimated is the
combined use of spinosad together with that of spinetoram, since most
new uses of spinetoram will likely replace a previous use of spinosad.
An average market leader PCT, based on three recent surveys of
pesticide usage, if available, is used for chronic risk assessment. The
average market leader PCT may be based on one or two survey years if
three are not available. Also, with limited availability of data, the
average market leader PCT may be based on a cross-section of state
PCTs. Comparisons are only made among pesticides of the same pesticide
type (i.e., the leading insecticide on the use site is selected for
comparison with the new insecticide), or, for refined estimates, among
pesticides targeting the same pests. The market leader PCTs are used to
determine the average for the same pesticide or for different
pesticides for any year since the same or different pesticides may
dominate for each year. Typically, EPA uses U.S. Department of
Agriculture/National Agricultural Statistics Service (USDA/NASS) as the

source for raw PCT data because it is publicly available. When a
specific use site is not surveyed by USDA/NASS, EPA uses other sources
including proprietary data.
    An estimated PPCT, based on the average PCT of the market leaders,
is appropriate for use in chronic dietary risk assessment. This method
of estimating PPCT for a new use of a registered pesticide or a new
pesticide produces a high-end estimate that is unlikely, in most cases,
to be exceeded during the initial 5 years of actual use. Predominant
factors that bear on whether the PPCT could be exceeded may include
PCTs of similar chemistries, pests controlled by alternatives, pest
prevalence in the market and other factors. All relevant information
currently available for predominant factors has been considered for the
combined use of spinetoram and spinosad on each of these several crops.
It is the Agency's opinion that it is unlikely that actual combined
PCTs for spinetoram and spinosad will exceed the corresponding
estimated PPCTs during the next 5 years.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions B and C, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which spinosad may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spinosad and spinetoram in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of spinosad and spinetoram. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/oppefed1/models/
water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of spinosad for surface
water are estimated to be 34.5 parts per billion (ppb) for acute
exposures, and 10.5 ppb for chronic exposures. For ground water, the
estimated drinking water concentration is 1.1 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. As explained above, an acute
dietary risk assessment was not conducted for spinosad and spinetoram.
For chronic dietary risk assessment, the water concentration of value
10.5 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    The Agency has concluded that spinosad and spinetoram are
toxicologically equivalent; therefore, residential exposure to both
spinosad and spinetoram was evaluated. Spinosad is currently registered
for homeowner application to turf grass and ornamentals and spinetoram
is registered for homeowner applications to gardens, lawns/ornamentals
and turf grass.
    There is potential for residential handler and postapplication
exposures to both spinosad and spinetoram. Since spinosad and
spinetoram control the same pests, EPA concluded that these products
will not be used in combination with each other and combining the
residential exposures is unnecessary. Short-term residential inhalation
risks were estimated for adult residential handlers, as well as short-
term postapplication incidental oral risks (hand-to-mouth, object-to-
mouth and soil ingestion) for toddlers, based on applications to home
lawns, home gardens and ornamentals. Dermal exposures were not
assessed, since no dermal endpoints of concern were identified in the
toxicology studies for spinosad and spinetoram.
    In addition, a registered fruit fly bait application scenario
permits application to non-crop vegetation, which may result in
residential exposures to spinosad. Based on the application rates, EPA
concluded that residential exposure resulting from this scenario would
be insignificant when compared to the residential exposure resulting
from the turf/ornamental application scenarios; therefore, a
quantitative analysis of residential exposure resulting from the fruit
fly bait application scenario is unnecessary and was not performed.
    4. 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, 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 has not found spinosad and spinetoram to share a common
mechanism of toxicity with any other substances, and spinosad and
spinetoram do not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that spinosad and spinetoram do not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of 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 based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). 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.
    2. Prenatal and postnatal sensitivity. The following acceptable
studies are available for both spinosad and spinoteram: Developmental
toxicity studies in rats and rabbits and a 2-generation reproduction
study in rats. There is no evidence of increased susceptibility of rat
or rabbit fetuses to

in utero exposure to spinosad or spinetoram. In the spinosad and
spinetoram rat and rabbit developmental toxicity studies, no
developmental toxicity was observed at dose levels that induced
maternal toxicity. In the spinosad 2-generation rat reproduction study,
maternal and offspring toxicity were equally severe, indicating no
evidence of increased susceptibility. In the spinetoram 2-generation
rat reproduction study, no adverse effects were observed in the
offspring at dose levels that produced parental toxicity. Therefore,
there is no evidence of increased susceptibility and there are no
concerns or residual uncertainties for prenatal and/or postnatal
toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for spinosad is complete, except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA.
    There was some evidence of adverse effects on the organs of the
immune system at the LOAEL in three short-term studies with spinosad or
spinetoram. In these studies, anemia was observed in multiple species
(rats, mice and dogs) with the presence of histiocytic aggregates of
macrophages in various organs and tissues (lymph nodes, spleen, thymus,
and bone marrow). Aggregation of macrophages was indicative of immune
stimulation in response to insults of the chemical exposure and was
considered secondary effects of the toxic effect to the hematopoetic
system. Therefore, these effects are not considered to be indicative of
frank immunotoxicity. In the spinetoram chronic toxicity study in dogs,
areteritis and necrosis of the areterial walls of the thymus was seen
in one female dog at the HDT. This finding is attributed to the
exacerbation of the spontaneous arteritis present in genetically
predisposed Beagle dogs (``Beagle Pain Syndrome''), not immunotoxicity.
Further, a clear NOAEL was attained in each of these studies, and the
observed histopathologies were generally observed in the presence of
other organ toxicity. In addition, spinosad and spinetoram do not
belong to a class of chemicals (e.g., the organotins, heavy metals, or
halogenated aromatic hydrocarbons) that would be expected to be
immunotoxic.
    Based on the above considerations, EPA does not believe that
conducting a special series OPPTS Guideline 870.7800 immunotoxicity
study will result in a POD less than the NOAEL of 2.49 miligrams/
kilograms/day (mg/kg/day) already set for spinosad and spinetoram.
Consequently, an additional database uncertainty factor does not need
to be applied.
    ii. There is no indication that spinosad and spinetoram are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spinosad and spinetoram result in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on tolerance-level residues or reliable data from field trial studies
and 100 PCT for all registered and proposed commodities except certain
feed crop commodities. The PPCT estimates used to refine certain feed
crop estimates provide conservative, high-end estimates developed using
the market leader approach that are unlikely to be exceeded.
Conservative ground and surface water modeling estimates were used to
assess exposure to spinosad and spinetoram in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
spinosad and spinetoram.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spinosad and spinetoram are not expected to pose an acute risk.
    2. Chronic risk. Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of spinosad and spinetoram are not expected; therefore, the
chronic aggregate exposure assessment consists of exposures from food
and water only. Using the exposure assumptions described in this unit
for chronic exposure, EPA has concluded that chronic exposure to
spinosad and spinetoram from food and water will utilize 95% of the
cPAD for children 1 to 2 years old, the population group receiving the
greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Spinosad and spinetoram are currently registered for uses that
could result in short-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to spinosad and
spinetoram. Using the exposure assumptions described in this unit for
short-term exposures, EPA has concluded the combined short-term food,
water, and residential exposures aggregated result in aggregate MOEs of
greater than or equal to 160 for all population subgroups. As the
aggregate MOEs are greater than 100 for all population subgroups,
including infants and children, short-term aggregate exposure to
spinosad and spinetoram is not of concern to EPA.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Spinosad and spinetoram are not registered for any use patterns
that would result in intermediate-term residential exposure. Therefore,
the intermediate-term aggregate risk is the sum of the risk from
exposure to spinosad and spinetoram through food and water, which has
already been

addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, spinosad and
spinetoram were classified as ``not likely to be carcinogenic to
humans,'' and are not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spinosad and spinetoram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method RES 94025, GRM 94.02 (a high performance liquid
chromatography method with ultraviolet absorption detection (HPLC/UV))
has been adequately validated and determined to be acceptable to
enforce the tolerance expression in plant commodities. In addition, the
following additional methods (which are essentially similar to GRM
94.02) have been submitted for other crop matrices: GRM 95.17 for leafy
vegetables; GRM 96.09 for citrus; GRM 96.14 for tree nuts; GRM 95.04
for fruiting vegetables; and GRM 94.02.S1 for cotton gin byproducts.
These methods have been forwarded to the Food and Drug Administration
(FDA) for inclusion in Pesticide Analytical Methods Volume II (PAM II).
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no Canadian maximum residue limits (MRLs)
established for residues of spinosad in or on the crops associated with
this review. Codex MRLs exist for spinosad on almond hull (2 ppm) and
almond nutmeat (0.01 ppm). These MRLs are based on field trial data
which employed a 14-day pre-harvest interval (PHI), while the U.S.
almond hull (19 ppm) and tree nut (0.10 ppm) tolerances are based on a
1-day PHI. Since the U.S. and Codex tolerances are based on different
application scenarios and since the U.S. tolerances are significantly
greater (10x) than those currently established by Codex, harmonization
is not possible.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA revised
tolerances for certain proposed commodities as follows: almond, hulls
from 9.0 ppm to 19 ppm; nut, tree, group 14 from 0.08 ppm to 0.10 ppm;
and pistachio from 0.08 ppm to 0.10 ppm. EPA revised the tolerance
levels based on analysis of the residue field trial data using the
Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance
for Setting Pesticide Tolerances Based on Field Trial Data.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad,
consisting of two related active ingredients: Spinosyn A (Factor A;
CAS131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione; and Spinosyn D (Factor D; CAS131929-63-0) or 2-[(6-
deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on almond, hulls at
19 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at
0.10 ppm; and pomegranate at 0.30 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 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 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 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) (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).

VII. 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: September 8, 2009.
Lois Rossi,
Director, Registration 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 180.495 is amended in paragraph (a) by revising the entries
in the table for ``Almond, hulls''; ``Nut, tree, group 14'' and
``Pistachio''; and by alphabetically adding entries for ``Date'' and
``Pomegranate'' to the table to read as follows:

180.495  Spinosad; tolerances for residues.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Almond, hulls.........................................                                                        19
                                                    * * * * *
Date..................................................                                                      0.10
                                                    * * * * *
Nut, tree, group 14...................................                                                      0.10
                                                    * * * * *
Pistachio.............................................                                                      0.10
Pomegranate...........................................                                                      0.30
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. E9-22534 Filed 9-22-09; 8:45 am]

BILLING CODE 6560-50-S


Record of Communication

Subject:  NIST Cost Containment Procedures for Cylinder Analysis

On October 30, 2009, Frank Guenther of the National Institute of
Standards and Technology (NIST) responded to an inquiry from John
Schakenbach of the Environmental Protection Agency (EPA) regarding NIST
procedures to keep cylinder analysis cost as low as possible.

The NIST cost containment strategy is:

1) Receipt of a batch of cylinders all within the same predefined
concentration range allows us to setup instrumentation and form a
calibration curves more efficiently. This has been arraigned in the past
through the contractor and works very well.  Also. scheduling batches of
cylinders to arrive when NIST is ready for them will allow NIST to more
efficiently schedule their resources.

2) The cross interactions of the analytical species on the
instrumentation we use has been modeled well already.  Future work can
make use of that modeling, where we only need to confirm the correction
factors are still good before using them.

3) NIST has agreed to analyze these cylinders to 0.5 % uncertainty (1 %
expanded uncertainty).  The reason for this uncertainty goal is to allow
reasonable certainty when judging a audit cylinder with 2 % expanded
uncertainty.  No reasonable cost gains will be achieved by increasing
our uncertainty to 1 % (2% expanded).

4) Since our uncertainty requirements are relatively high (1 %
expanded), we can use intermediate standards for all of this work.  This
keeps the cost down, because our high value primary standards do not
have to be used. In addition NIST has invested in tri-mix working
standards that will allow us to validate our methods much quicker.

5) In the future we will be working on a FTIR method that may allow us
to further reduce costs by consolidating all analytical work to an
automated instrument.

6) High concentration audit cylinders will always cost less to analyze.
The lowest concentration audit cylinders will cost NIST approximately 25
% more to analyze.

 PAGE

 PAGE


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on December 29, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-16786

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  China Southern Airlines Company Limited			Date Filed:
October 27, 2004

Relief requested: (1) Renew exemption to engage in scheduled foreign air
transportation of persons, property and mail between Guangzhou and
Shanghai, People’s Republic of China, on the one hand, and Saipan,
Commonwealth of the Northern Mariana Islands, on the other hand; and (2)
amend that authority to the extent necessary to permit China Southern to
serve Tinian, Commonwealth of the Northern Mariana Islands as an
authorized coterminal point.

Date and citation of last action:  December 31, 2003, and April 16,
2004, in this docket.

Applicant representative:  George U. Carneal & William L. Elder (202)
637-8787

DOT Analyst:  Gordon H. Bingham<PHONE_NUMBER>

Responsive pleadings:  None filed

	DISPOSITION

Action:  Approved in part, deferred in part						Action date:  December
29, 2004

Effective dates of authority granted:  December 29, 2004-December 29,
2005

Basis for approval (bilateral agreement/reciprocity):  U.S.-China Air
Transport Services Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X Standard exemption conditions (attached) and China Southern’s
foreign air carrier permit (Order 2001-11-4)

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

											Attachment

Foreign Carrier Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

												05/2004

  By letter dated December 20, 2004, and filed in this docket, China
Southern requests that we defer action on its request to serve Tinian
until such time as the Transportation Security Administration (TSA)
completes a security assessment of Tinian.  China Southern further
requests that we expeditiously grant that portion of its October 27
application that seeks renewal of its exemption authority to serve the
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