[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37581-37582]
[FR Doc No: 2023-12208]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0042]

Occupational Safety and Health Administration Conflict of
Interest (COI) and Disclosure Form; Extension of the Office of
Management and Budget's (OMB) Approval of Information Collection
(Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its request to extend
the Office of Management and Budget's (OMB) approval of information
collection. Regarding the Occupational Safety and Health Administration
Conflict of Interest (COI) and Disclosure Form.

DATES: Comments must be submitted (postmarked, sent, or received) by
August 7, 2023.

ADDRESSES:
    Electronically: You may submit comments, including attachments,
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the instructions online for submitting comments.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov. Documents in the docket are
listed in the http://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection through the OSHA
Docket Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for assistance in locating docket submissions.
    Instructions: All submissions must include the agency name and the
OSHA Docket Number for this Federal Register notice (OSHA-2009-0042).
OSHA will place comments, including personal information, in the public
docket, which may be available online. Therefore, OSHA cautions
interested parties about submitting personal information such as Social
Security numbers and birthdates.
    For further information on submitting comments, see the ``Public
Participation'' heading in the section of this notice titled
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Seleda Perryman or Theda Kenney,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of the continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, the collection instruments are clearly understood, and
OSHA's estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of effort in
obtaining information (29 U.S.C. 657).
    OSHA conducts peer reviews of a draft product for quality by
specialists in the field who were not involved in producing the draft.
The selection of participants in a peer review is based on expertise,
considering their independence and any actual or potential conflicts of
interest. The Office of Management and Budget published the Final
Information Quality Bulletin for Peer Review on December 15, 2004. The
Bulletin states ``. . . the agency must address reviewers' potential
conflicts of interest (including those stemming from ties to regulated
businesses and other stakeholders) and independence from the agency.''
The Bulletin requires agencies to adopt or adapt the committee
selection policies employed by the National Academy of Sciences (NAS)
when selecting peer reviewers who are not government employees. To
fulfill this requirement, OSHA has developed a Conflict of Interest
(COI) and Disclosure Form, based on NAS' Conflict of Interest
Disclosure form. This form will be used to determine whether a conflict
exists for a potential peer review panel member.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply--
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    There are no changes in burden hours from the previous Information
Collection Request for obtaining the necessary background information
and disclosure of conflict-of-interest information to ensure that
invited experts are not compromised.
    OSHA will summarize the comments submitted in response to this
notice and will include this summary in the request to OMB to extend
the approval of the information collection requirements.
    Type of Review: Extension of a currently approved collection.
    Title: Occupational Safety and Health Administration Conflict of
Interest (COI) and Disclosure Form.
    OMB Control Number: 1218-0255.
    Affected Public: Individuals and Households.
    Number of Respondents: 36.
    Frequency: On occasion.
    Average Time per Response: OSHA estimates it will take thirty
minutes (30/60 hour) to complete the short version of the COI form, and
one (1) hour to complete the long version of the COI form.
    Estimated Total Number of Responses: 36.

    Estimated Total Burden Hours: 27.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the agency name
and the OSHA Docket Number for this ICR (Docket No. OSHA-2009-0042).
You may supplement electronic submissions by uploading document files
electronically.
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information, such as their social security number
and date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available from the website and for assistance in using the internet to
locate docket submissions.

V. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506, et seq.) and Secretary of Labor's Order No. 1-
2012 (77 FR 3912).

    Signed at Washington, DC, on May 25, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-12208 Filed 6-7-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: August 13, 2009 (Volume 74, Number 155)]
[Rules and Regulations]
[Page 40753-40760]
[DOCID:fr13au09-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0805; FRL-8426-9]

Spinetoram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerances for the combined
residues of spinetoram in or on almond, hulls; nut, tree, group 14; and
pistachio and establishes tolerances for date; pomegranate; pineapple;
pineapple, processed residue; spice, subgroup 19B, except black pepper;
and hop, dried cones. The Interregional Research Project Number 4 (IR-
4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 13, 2009. Objections and
requests for hearings must be received on or before October 13, 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-2008-0805. 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: Samantha Hulkower, 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-2008-0805 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 October 13, 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-2008-0805, 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
8E7450) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W., Princeton, NJ 08540. The petition
requested that 40 CFR 180.635 be amended by establishing tolerances for
residues of the insecticide spinetoram, expressed as a combination of:
    XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-
methyl-,(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR);
    XDE-175-L: 1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-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-4,14-
dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
    ND-J:(2R,3aR,5aR,5bS,9S,13S, 14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and
    NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-
14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-
methyltetrahydro-2H-pyran-3-yl(methyl)formamide
in or on the raw agricultural commodities pineapple at 0.02 parts per
million (ppm); pomegranate at 0.3 ppm; date at 0.1 ppm; spice, subgroup
19B, except black pepper at 1.7 ppm; hop, dried cones at 22 ppm; and
pineapple, process residue at 0.08 ppm. Additionally, the petition
proposed to increase the levels of existing tolerances for nut, tree,
group 14 and pistachio from 0.04 to 0.08 ppm and almond, hulls from 2.0
ppm 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 tolerances to higher levels than proposed for almond, hulls;
nut, tree, group 14; pistachio; pineapple; and pineapple, process
residue. The reason for these changes are explained in Unit IV.D.

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 combined residues of spinetoram on almond, hulls at 19
ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at
0.10 ppm; pomegranate at 0.30 ppm; pineapple at 0.04 ppm; pineapple,
processed residue at 0.15 ppm; spice, subgroup 19B, except black pepper
at 1.7 ppm; and hop, dried cones at 22 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.
    Spinetoram has low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is a dermal sensitizer but not an eye
or dermal irritant. In subchronic toxicity studies conducted in rats,
mice and dogs, spinetoram produces multi-organ toxicity. Treatment had
no adverse effects on

survival but decreases in body weight, body weight gain and/or food
consumption were observed in all three species. Treatment-related
findings included the presence of a mild anemia, alterations in
clinical chemistry parameters, increased liver weights, presence of
histiocytic aggregates of macrophages in various organs and tissues,
and degeneration with regeneration of the kidney tubules. Dogs appear
to be the most sensitive species. In the subchronic study with dogs,
lower thymus weights, atrophy of the thymic cortex, arteritis and/or
perivascular inflammation in numerous organs with necrosis of the bone
marrow leading to regenerative anemia was seen. In the chronic study
with dogs, there were no treatment-related effects on survival, body
weight, hematology, clinical chemistry or gross pathology. Treatment-
related changes were limited to arteritis and necrosis of the arterial
walls of the epididymides in males and thymus, thyroid, larynx, and
urinary bladder in females. It is postulated that chronic treatment
exacerbated the spontaneous arteritis in genetically predisposed Beagle
dogs (it is called the ``Beagle Pain Syndrome''). In developmental
toxicity studies, there is no evidence of increased susceptibility
following in utero exposures in rats and rabbits. In the 2-generation
reproduction study, no adverse effects were observed on the offspring
at dose levels that produced parental toxicity. EPA has concluded that
spinetoram is toxicologically identical to another pesticide, spinosad.
Based on the structural similarity of spinetoram and spinosad and the
similarity of the toxicological database for the currently available
studies, spinetoram is classified as ``not likely to be carcinogenic to
humans'' based on lack of evidence for carcinogenicity of spinosad in
mice and rats. No indication of neurotoxicity was observed in the acute
neurotoxicity screening battery in rats, or in the subchronic and
chronic toxicity studies conducted on spinetoram. All the mutagenicity
studies conducted on spinetoram were negative. The no-observed-adverse-
effect-level (NOAEL) derived from the chronic dog study is well
characterized, and together with the traditional uncertainty/safety
factors will provide adequate protection for effects observed in
laboratory animals. Specific information on the studies received and
the nature of the adverse effects caused by spinetoram as well as the
NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies can be found at http://www.regulations.gov in document
Human Health Risk Assessment for Application of spinosad to date and
pomegranate and spinetoram to pineapple, date, pomegranate, hopes, and
spices (crop subgroup 19B, except black pepper) on page 4 and
attachment 3 pages 49-54 in docket ID number EPA-HQ-OPP-2008-0805.

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:
Spinetoram and spinosad are large molecules with nearly identical
structures; and 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 spinetoram/spinosad
used for human risk assessment can be found at http://
www.regulations.gov in the document Human Health Risk Assessment for
Application of spinosad to date and pomegranate and spinetoram to
pineapple, date, pomegranate, hopes, and spices (crop subgroup 19B,
except black pepper) on page 8 in docket ID number EPA-HQ-OPP-2008-
0805.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spinetoram/spinosad, EPA considered exposure under the
petitioned-for tolerances as well as all existing spinetoram/spinosad
tolerances in 40 CFR 180.635. EPA assessed dietary exposures from
spinetoram/spinosad 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
spinetoram/spinosad; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. Spinosad is registered for application to all
of the same crops as spinetoram, with similar pre-harvest and
retreatment intervals, and application rates greater than or equal to
spinetoram. Further, both products control the same pest species. For
this reason, EPA has concluded it would overstate exposure to assume
that residues of both spinosad and spinetoram would appear on the same
food. Rather, EPA aggregated exposure by either assuming that all
commodities contain spinosad residues (because side-

by-side spinetoram and spinosad residue data indicated that spinetoram
residues were less than or equal to spinosad residues) or summing the
percentage of a crop that would be treated with spinosad and the
percentage that would be treated with spinetoram.
    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 Surveys of Food Intakes by Individuals
(CSFII). As to residue levels in food, the chronic analysis assumed
100% crop treated for all food crop commodities; average field-trial
residues for apple, Brassica leafy vegetables, citrus, fruiting
vegetables, herbs, banana, and strawberry; tolerance-level residues for
the remaining food crop commodities; DEEM\tm\ (ver. 7.81) 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 spinosad processing factors were assumed. Residues in
livestock were refined through the incorporation of a refined dietary
burden (average feed-crop residues and percent crop treated estimates)
and through the incorporation of average residues from the feeding and
dermal magnitude of the residue studies.
    iii. Cancer. Spinetoram is considered to be ``not likely to be a
carcinogen to humans'' based on its similarity to another spynosin
pesticide, spinosad. Preliminary results of a carcinogenicity study in
mice indicate that spinetoram is not carcinogenic to mice at doses up
to 37.5 milligram/kilogram/day (mg/kg/day). Consequently, a
quantitative cancer exposure and risk assessment is not appropriate for
spinetoram.
    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.
    The EPA assumed 100% crop treated for all food crop commodities;
however, in calculating beef and dairy cattle dietary burdens, the
Agency used combined spinosad and spinetoram projected percent crop
treated (PPCT) information as follows:
    39% sweet corn forage.
    50% leaves of root and tuber vegetables.
    5% sorghum grain.
    5% soybean seed meal.
    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 average 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 use of spinetoram will likely replace
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 used to determine the average may consist of PCTs
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 USDA/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 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.
Of greatest relevance here is that both spinosad and spinetoram control
a relatively narrow range of pests compared to the market leaders.
Based on this analysis, EPA believes 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 spinetoram 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 spinetoram/spinosad in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of spinetoram/spinosad. 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 spinetoram for acute
exposures are estimated to be 14.419 parts per billion (ppb) for
surface water and 0.072 ppb for ground water. For chronic exposures for
non-cancer assessments are estimated to be 6.171 ppb for surface water
and 0.072 ppb for ground water. EDWCs for spinosad for acute exposures
are estimated to be 34.5 ppb for surface water and 1.1 ppb for ground
water. For chronic exposures for non-cancer assessments are estimated
to be 10.5 ppb for surface water and 1.1 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. 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. Spinetoram is
registered for homeowner applications to gardens, lawns/ornamentals and
turf grass. No dermal endpoints for either spinetoram or spinosad were
identified. Therefore, only short-term incidental oral exposures to
toddlers were evaluated for the registered turf and ornamental
application scenarios for spinosad and spinetoram and short-term
inhalation exposure to handler/applicators for the registered home
garden, turf, and ornamental application scenarios.
    There is potential for residential handler and post-application
exposures to both spinosad and spinetoram. Since spinosad and
spinetoram control the same pests, EPA concludes that these products
will not be used for the same uses in combination with each other and
thus combining spinosad and spinetoram residential exposures would
overstate exposure. Short-term residential inhalation risks were
estimated for adult residential handlers, as well as short-term post-
application incidental oral risks for toddlers, based on applications
to home lawns, home gardens and ornamentals.
    EPA notes that for spinosad the registered fruit fly bait
application scenario permits application to non-crop vegetation and
this use may result in residential exposures. Based on the application
rates (fruit fly bait - 0.0003 lb ai/acre; turf/ornamental - 0.41 lbs
ai/acre), EPA concludes that residential exposure resulting from the
fruit fly application will be insignificant when compared to the
exposure resulting from homeowner uses on the turf/ornamentals.
Therefore, quantitative analysis of the residential exposure resulting
from the fruit fly bait application 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 spinetoram/spinosad to share a common mechanism
of toxicity with any other substances, and spinetoram/spinosad does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
spinetoram/spinosad does 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. There is no evidence of
increased susceptibility of rat and 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 did not induce maternal toxicity. In the
spinosad 2-generation reproduction studies, maternal and offspring
toxicity were equally severe, indicating no evidence of increased
susceptibility. In the spinetoram 2-generation reproduction study, no
adverse effects were observed on 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 pre-natal and/or post-natal 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 spinetoram is complete, except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Harmonized 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 chronic study with 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 870.7800 immunotoxicity study will result
in a POD less than the NOAEL of 2.49 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 spinetoram/spinosad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spinetoram/spinosad results 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 utilized 100 PCT and
tolerance-level residues, and DEEM\TM\ default processing factors for
all registered and proposed commodities and refined livestock
estimates. These refinements are based on reliable data. The EPA used
PPCT information when calculating livestock dietary burdens for sweet
corn forage, leaves of root and tuber vegetables, sorghum grain, and
soybean seed meal. EPA believes that the PPCT estimates used are
conservative estimates. EPA made conservative (protective) assumptions
in the ground water and surface water modeling used to assess exposure
to spinetoram/spinosad in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
spinetoram/spinosad.

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,
spinetoram/spinosad is not expected to pose an acute risk.
    2. Chronic risk. Since there are no registered/proposed uses which
result in chronic residential exposures, the chronic aggregate exposure
assessment consists of exposure from food and water. Using the exposure
assumptions described in this unit for chronic exposure, EPA has
concluded that chronic exposure to spinetoram/spinosad from food and
water will utilize 95% of the cPAD for children 1-2 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).
    Spinetoram/spinosad is 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 spinetoram/spinosad.
    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 >=160.
Short-term aggregate risk does not exceed the LOC for EPA (MOE of
<100).
    4. Intermediate-term risk. Spinetoram/spinosad is 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 spinetoram/spinosad 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. The Agency considers
spinetoram to be ``Not Likely to be Carcinogenic to Humans.'' See Unit
III.C.iii. for more detailed information.
    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 spinetoram/spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    FDA Multiresidue Methods (MRMs): XDE-175-J, XDE-175-L, ND-J, NF-J,
ND-L, and NF-L were screened through the Food and Drug Administration
Pesticide Analytical Methods Volume I (PAM I) MRMs. None of the test
substances were found to be fluorescent using procedures outlined in
Protocol A. All test substances were subjected to Protocol C, modules
DG1, DG5, DG13, DG17, and DG18. Test substances were determined to be
non-chromatographable by the chosen gas chromatography modules
described in Protocol C. Due to the poor sensitivity of the test
substances to detection by methods described in Protocol C, no further
analyses were performed by Protocols D, E, or F. Since the test
substances are not acids, phenols, or substituted ureas, analyses were
not performed using Protocols B or G. The test substances were not
detectable through FDA PAM I Protocols A and C; therefore, these
methods are unsuitable for enforcement. The MRM results were forwarded
to the FDA.
    Adequate enforcement methodology. Plants: Method GRM 05.03 (HPLC/
MS/MS). Livestock: Method GRM 05.15 HPLC/mass spectrometry (MS) is
available to enforce the tolerance expression. The method 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 established Codex, Canadian, or Mexican MRLs
for residues of spinetoram on the requested crops.

C. Revisions to Petitioned-For Tolerances

    The tolerance expression for spinetoram includes residues of XDE-

175-J, XDE-175-L, ND-J, and NF-J. EPA is establishing tolerances for
the following commodities at levels higher than proposed: nut, tree,
group 14 and pistachio raised to 0.10 ppm; almond, hulls raised to 19
ppm; pineapple to 0.04 ppm; and pineapple, processed residue 0.15 ppm.
These changes are based on the residue field trial data and the North
American Free Trade Agreement (NAFTA) MRL Spreadsheet.

V. Conclusion

    Therefore, tolerances are established for combined residues of
spinetoram, expressed as a combination of:
    XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro14-
methyl-, (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR);
    XDE-175-L: 1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-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-4,14-
dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
    ND-J:(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and
    NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-
deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-
14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-
methyltetrahydro-2H-pyran-3-yl(methyl)formamide
in or on the following commodities is increased to almond, hulls at 19
ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; date at
0.10 ppm; pomegranate at 0.30 ppm; pineapple 0.04 ppm; pineapple,
processed residue at 0.15 ppm; spice, subgroup 19B, except black pepper
at 1.7 ppm; and hop, dried cones at 22 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: July 31, 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 180.635 is amended by revising the entries in the table in
paragraph (a) for almond, hulls; nut, tree, group 14; and pistachio and
alphabetically adding entries for date; hop, dried cones; pineapple;
pineapple, processed residue; pomegranate; and spice, subgroup 19b,
except black pepper, to read as follows:

Sec.  180.635  Spinetoram; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
                                * * * * *
Almond, hulls................................................         19
                                * * * * *
Date.........................................................       0.10
                                * * * * *
Hop, dried cones.............................................         22

                                * * * * *
Nut, tree, group 14..........................................       0.10
                                * * * * *
Pineapple....................................................       0.04
Pineapple, processed residue.................................       0.15
Pistachio....................................................       0.10
Pomegranate..................................................       0.30
                                * * * * *
Spice, subgroup 19B, except black pepper.....................        1.7
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-19195 Filed 8-12-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Proposed Rules]
[Page 14436-14437]
[DOCID:fr22mr06-29]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2006-0124; FRL-8040-7]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to approve a request from the Indiana
Department of Environmental Management (IDEM) to revise the Indiana
State Implementation Plan (SIP). The revision consists of the repeal of
326 IAC 6-1, and its replacement by new articles 326 IAC 6.5 and 326
IAC 6.8. 326 IAC 6.5 contains particulate matter emission limitations
for sources in all counties in Indiana, with the exception of Lake
County. Sources in Lake County are addressed in 326 IAC 6.8. The
revision does not change any control requirements or any other
provisions in 326 IAC 6-1.
    In the final rules section of this Federal Register, EPA is
approving the SIP revision as a direct final rule without prior
proposal, because EPA views this as a noncontroversial revision and
anticipates no adverse comments. A detailed rationale for the approval
is set forth in the direct final rule. If we do not receive any adverse
comments in response to these direct final and proposed rules, we do
not contemplate taking any further action in relation to this proposed
rule. If EPA receives adverse comments, we will withdraw the direct
final rule and will respond to all public comments in a subsequent
final rule based on this proposed rule. EPA will not institute a second
comment period on this action. Any parties interested in commenting on
this action should do so at this time.

DATES: Written comments must be received on or before April 21, 2006.

ADDRESSES: Submit comments, identified by Regional Material in EDocket
(RME) ID No. EPA-R05-OAR-2006-0124 by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the

on-line instructions for submitting comments.
    Agency Web site: http://docket.epa.gov/rmepub/. RME, EPA's

electronic public docket and comment system, is EPA's preferred method
for receiving comments. Once in the system, select ``quick search,''
then key in the appropriate RME Docket identification number. Follow
the online instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>    Fax:<PHONE_NUMBER>.
    Mail: You may send written comments to: John M. Mooney, Chief,
Criteria Pollutant Section, (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
    Hand delivery: Deliver your comments to: John M. Mooney, Chief,
Criteria Pollutant Section (AR-18J), U.S. Environmental Protection
Agency, Region 5, 77 West Jackson Boulevard, 18th floor, Chicago,
Illinois 60604.
    Such deliveries are only accepted during the Regional Office's
normal hours of operation. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding
Federal holidays.
    Instructions: Direct your comments to RME ID No. EPA-R05-OAR-2006-
0124. EPA's policy is that all comments received will be included in
the public docket without change, 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 RME, regulations.gov,
or e-mail. The EPA RME Web site and the Federal regulations.gov Web
site are ``anonymous access'' systems, 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 RME or regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public 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. For additional instructions on submitting
comments, go to section I(B) of the SUPPLEMENTARY INFORMATION section
of this document.
    Docket: All documents in the electronic docket are listed in the
RME index at http://www.epa.gov/rmepub/. Although listed in the index,

some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Publicly
available docket materials are available either electronically in RME
or in hard copy at Environmental Protection Agency, Region 5, Air and
Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604.
(Please telephone Jonathan Nichols at<PHONE_NUMBER> before visiting
the Region 5 Office.)

FOR FURTHER INFORMATION CONTACT: Jonathan Nichols, Life Scientist,
Criteria Pollutant Section, Air Programs Branch (AR-18J), USEPA, Region
5, 77 West Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>.
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information
    A. What Should I Consider as I Prepare My Comments for EPA?
II. What Action Is EPA Taking Today?
III. Where Can I Find More Information About This Proposal and the
Corresponding Direct Final Rule?

I. General Information

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

    1. Submitting CBI. Do not submit CBI to EPA through RME,
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the

comment that includes information claimed as CBI, a copy of the comment
that does not contain the information claimed as CBI must be submitted
for inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    b. 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.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. What Action Is EPA Taking Today?

    EPA is proposing to approve revisions to the Indiana SIP in one
area: To repeal 326 IAC 6-1, and to replace it with 326 IAC 6.5
``Particulate Matter Limitations for all counties with the exception of
Lake County,'' and 326 IAC 6.8 ``Particulate Matter Limitations for
Lake County.''
    This revision renumbers and simplifies the organizational structure
of the rule. IDEM has done this in order to streamline future rule
amendment processes by having a separate section for each company. This
rule eliminates the submittal of hundreds of pages of paper for one
emission limit amendment. The revision does not change any control
requirements or any other provisions in 326 IAC 6-1.

III. Where Can I Find More Information About This Proposal and the
Corresponding Direct Final Rule?

    For additional information, see the Direct Final Rule which is
located in the Rules section of this Federal Register. Copies of the
request and the EPA's analysis are available electronically at RME or
in hard copy at the above address. (Please telephone Jonathan Nichols
at<PHONE_NUMBER> before visiting the Region 5 Office.)

    Dated: February 17, 2006.
Norman Niedergang,
Acting Regional Administrator, Region 5.
[FR Doc. 06-2695 Filed 3-21-06; 8:45 am]

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