[Federal Register: May 17, 2010 (Volume 75, Number 94)]
[Notices]
[Page 27551]
[DOCID:fr17my10-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER07-125-001]

Keystone Energy Partners, LP; Notice of Filing

May 10, 2010.
    Take notice that on December 16, 2009, Keystone Energy Partners, LP
submit for filing an Updated Market Power Analysis, Request for
Category 1 Status, and updated FERC Electric Tariff, Original Volume No
1.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 1, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-11633 Filed 5-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71873-71875]
[FR Doc No: 2023-22976]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4128]

Guidance Documents Referencing Pre-Existing Tobacco Products;
Guidance for Industry; Availability; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of revised final guidances for industry entitled
``Demonstrating the Substantial Equivalence of a New Tobacco Product:
Responses to Frequently Asked Questions,'' and ``Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007.'' Following the issuance of the final rules entitled
``Content and Format of Substantial Equivalence Reports; Food and Drug
Administration Actions on Substantial Equivalence Reports'' (SE) and
``Premarket Tobacco Product Applications and Recordkeeping
Requirements'' (PMTA), FDA has made minor updates to these guidances
for consistency with the terminology used in those rules. FDA is also
announcing the withdrawal of the final guidances entitled ``Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products,'' and ``Investigational Use of Deemed, Finished Tobacco
Products That Were on the U.S. Market on August 8, 2016, During the
Deeming Compliance Periods,'' and a draft guidance entitled
``Substantial Equivalence Reports: Manufacturer Requests for Extensions
or to Change the Predicate Tobacco Product,'' which are obsolete due to
the issuance of the SE final rule or the end of the compliance period
for deemed, finished tobacco products that were on the U.S. market on
August 8, 2016.

DATES: The announcement of the guidance is published in the Federal
Register on October 18, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-4128 for ``Guidance Documents Referencing Pre-Existing
Tobacco Products.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential

Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of these guidances to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the guidances may be sent. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance documents.

FOR FURTHER INFORMATION CONTACT: Natalie Gibson, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. The
Tobacco Control Act grants FDA authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect public
health generally and to reduce tobacco use by youth. FDA is announcing
the availability of revised final guidances for industry, collectively
entitled ``Guidance Documents Referencing Pre-Existing Tobacco
Products.''
    In the PMTA final rule (86 FR 55300, October 5, 2021) and the SE
final rule (86 FR 55224, October 5, 2021), FDA has changed the term
``grandfathered tobacco product'' to ``pre-existing tobacco product''
because it more appropriately describes these products. Specifically,
FDA considers a ``pre-existing tobacco product'' to mean a tobacco
product that was commercially marketed in the United States as of
February 15, 2007. FDA also made other minor changes to the revised
guidances to reflect updated terminology used in the SE final rule,
when appropriate. Details of the changes are described in the revision
history page included with each guidance.
    FDA is also withdrawing three guidances that are obsolete due to
the issuance of the SE final rule or due to the end of the compliance
period for deemed, finished tobacco products that were on the U.S.
market on August 8, 2016. The guidances along with their docket numbers
and status are listed in table 1.

                Table 1--Revised and Withdrawn Guidances
------------------------------------------------------------------------
              Title                   Docket No.            Status
------------------------------------------------------------------------
Demonstrating the Substantial     FDA-2011-D-0147...  Revised.
 Equivalence of a New Tobacco
 Product: Responses to
 Frequently Asked Questions.
Establishing That a Tobacco       FDA-2011-D-0125...  Revised.
 Product Was Commercially
 Marketed in the United States
 as of February 15, 2007.
Investigational Use of Deemed,    FDA-2016-D-3276...  Withdrawn.
 Finished Tobacco Products That
 Were on the U.S. Market on
 August 8, 2016, During the
 Deeming Compliance Periods.
Section 905(j) Reports:           FDA-2010-D-0635...  Withdrawn.
 Demonstrating Substantial
 Equivalence for Tobacco
 Products.
Substantial Equivalence Reports:  FDA-2014-D-0800...  Withdrawn.
 Manufacturer Requests for
 Extensions or to Change the
 Predicate Tobacco Product,
 Draft Guidance.
------------------------------------------------------------------------

    The revised final guidances are being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115) and represent the
current thinking of FDA on, among other things, the incorporation of
the term ``pre-existing tobacco product.'' They do not establish any
rights for any person and are not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While these guidances contain no collections of information, they
do refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in FDA's guidance entitled ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007''
have been approved under OMB control number 0910-0775.

III. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/TobaccoProducts/

Labeling/RulesRegulationsGuidance/default.htm, or https://www.regulations.gov.

    Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22976 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8433-8441]
[FR Doc No: 2020-02038]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0784; FRL-10004-12]

Acetamiprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
acetamiprid in or on multiple commodities that are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 14, 2020. Objections and
requests for hearings must be received on or before April 14, 2020, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0784, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2018-0784 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
April 14, 2020. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0784, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 19, 2019 (84 FR 16430) (FRL-9991-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E8715) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of acetamiprid, (1E)-N-[(6-chloro-
3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, including its
metabolites and degradates in or on the following raw agricultural
commodities: Tropical and subtropical, medium to large fruit, smooth,
inedible peel, subgroup 24B at 0.50 parts per million (ppm); leafy
greens subgroup 4-16A at 3.0 ppm; leaf petiole vegetable subgroup 22B
at 3.0 ppm; celtuce at 3.0 ppm; Florence fennel at 3.0 ppm; Brassica,
leafy greens, subgroup 4-16B at 15 ppm; Vegetable, Brassica, head and
stem, group 5-16 at 1.2 ppm; kohlrabi at 1.2 ppm; fruit, stone, group
12-12 at 1.5 ppm; nut, tree, group 14-12 at 0.10 ppm; rapeseed subgroup
20A at 0.01 ppm; and cottonseed subgroup 20C at 0.70 ppm.
    Additionally, the petition requested to amend 40 CFR 180.578 by
removing the established tolerances for residues of acetamiprid in or
on the following raw agricultural commodities: Vegetable, leafy, except
Brassica, group 4 at 3.00 ppm; Brassica, leafy greens, subgroup 5B at
15 ppm; turnip, greens at 15 ppm; Brassica, head and stem, subgroup 5A
at 1.20 ppm; fruit, stone, group 12, except plum, prune at 1.20 ppm;
plum, prune, fresh at 0.20 ppm; nut, tree, group 14 at 0.10 ppm;
pistachio at 0.10 ppm; canola, seed at 0.010 ppm; mustard, seed at
0.010 ppm; and cotton, undelinted seed at 0.60 ppm.
    That document referenced a summary of the petition prepared by
Nippon Soda Co., Ltd. c/o Nisso America Inc, the registrant, which is
available in the docket, http://www.regulations.gov. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
    Pursuant to its authority in FFDCA section 408(d)(4)(A)(i), EPA is
establishing tolerances that vary slightly from what the petitioner
requested. The reasons for these changes are 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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 acetamiprid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with acetamiprid 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.
    In all species tested, generalized nonspecific toxicity was
observed as decreases in body weight/body weight gain, food
consumption, and food efficiency. Hepatocellular hypertrophy was
observed in both mice and rats, and hepatocellular vacuolation in the
rat, but these liver effects alone are considered adaptive and not
indicative of an adverse effect. Other effects observed in the oral
studies include amyloidosis of multiple organs in the mouse
carcinogenicity study, tremors in high dose females in the mouse
subchronic study, and micro-concretions in the kidney papilla and
mammary hyperplasia in the rat chronic/carcinogenicity study.
    Acetamiprid is rapidly absorbed, metabolized, and eliminated. The
metabolism study in rats indicates 96-99% absorption following an oral
administration. Peak blood concentrations in the rat occur within 1-2
hours at the low dose (1 mg/kg), 3-6 hours post-dosing at the high dose
(50 mg/kg), and the main route of excretion is through the urine, which
is nearly complete by 48 hours for all doses. Metabolites of
acetamiprid account for 79-86% of the administered radioactivity, with
6-Chloronicotinic (IC-O) acid being the most abundant metabolite. There
were no significant sex differences noted in the ADME profile in rats.
    No effects were observed in the 21-day dermal study in the rabbit
and no inhalation studies were conducted. EPA has used a refined value
of 10% as a dermal absorption factor based on the rat dermal absorption
study and weight of evidence.
    Evidence of qualitative susceptibility was observed in the 2-
generation reproductive study, with the offspring effects (significant
reductions in pup weights, reduction in litter size and viability,
significant delays in weaning indices and the age to attain vaginal
opening and preputial separation) considered more severe than the
decrease in parental body weights. Qualitative susceptibility was also
seen in the developmental neurotoxicity study (DNT) with offspring
effects (decreased body weight, pre-weaning survival, and startle
response) occurring in the presence of marginal parental body weight
decreases.
    Evidence of neurotoxicity was observed in the rat acute
neurotoxicity study (decrease in locomotor activity, and at higher
doses: Tremors, difficulty in handling, walking on toes, dilated
pupils, chewing, coldness to the touch, abnormal gaits and/or posture,
decreased forelimb grip strength, and hind limb foot splay), subchronic
toxicity study in mice (tremors), the DNT (decreased startle response),
and comparative metabolism study (decreased alertness, reactivity,
spontaneous activity, locomotor activity, rearing, muscle tone, and
grip strength; as well as tremors, staggering, and depressed reflexes
in the rat, mouse, and/or rabbit). Subchronic immunotoxicity studies
were performed in both sexes in rats and mice, with no effects on the
immune system observed up to the highest dose tested. Acetamiprid and
its metabolites IC-0, IM-1-2, IM-1-4, IM-2-1, and IM-0 tested negative
for mutagenicity. With no treatment-related tumors seen in rats or
mice, the Agency has classified acetamiprid as not likely to be
carcinogenic to humans.
    Specific information on the studies received and the nature of the
adverse effects caused by acetamiprid 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 titled ``Acetamiprid. Human Health
Risk Assessment for Proposed Use on Tropical and Subtropical, Medium to
Large Fruit, Smooth, Inedible Peel Subgroup 24B; Greenhouse-grown
Peppers; and Crop Group Conversions and Expansions'' on pages 38-43 in
docket ID number EPA-HQ-OPP-2018-0784.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). 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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for acetamiprid used for
human risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Acetamiprid for Use in FFDCA Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                   Point of departure
        Exposure/scenario           and uncertainty/      RfD, PAD, LOC for     Study and toxicological effects
                                     safety factors        risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations).  NOAEL = 10 mg/kg/day  Acute RfD = 0.1 mg/   Co-critical studies.
                                  UFA = 10X              kg/day               Developmental Neurotoxicity in
                                  UFH = 10X             aPAD = 0.1 mg/kg/day   rat.
                                  FQPA SF = 1X                                LOAEL = 45 mg/kg/day based on
                                                                               decreased early pup survival on
                                                                               PND 0-1, and decreased startle
                                                                               response on PND 20/60 in males.
                                                                              Acute Neurotoxicity Study in rat.
                                                                              LOAEL = 30 mg/kg/day based on
                                                                               decreased locomotor activity.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All              NOAEL= 7.1 mg/kg/day  Chronic RfD = 0.071   Chronic Toxicity/Carcinogenicity
 populations).                    UFA = 10X              mg/kg/day             Study in rats.
                                  UFH = 10X             cPAD = 0.071 mg/kg/   LOAEL = 17.5 mg/kg/day based on
                                  FQPA SF = 1X           day                   decreased body weight and body
                                                                               weight gains in females and
                                                                               hepatocellular vacuolation in
                                                                               males.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to  NOAEL= 10 mg/kg/day   LOC for MOE = 100     Developmental Neurotoxicity in
 30 days).                        UFA = 10X                                    rat.
                                  UFH = 10X                                   LOAEL = 45 mg/kg/day based on
                                  FQPA SF = 1X                                 decreased body weight and body
                                                                               weight gains in offspring,
                                                                               decreased early pup survival on
                                                                               PND 0-1, and decreased startle
                                                                               response on PND 20/60 in males.
----------------------------------------------------------------------------------------------------------------
Incidental oral long-term         NOAEL= 7.1 mg/kg/day  LOC for MOE = 100     Chronic Toxicity/Carcinogenicity
 (greater than 6 months).         UFA= 10X                                     Study in rats.
                                  UFH= 10X                                    LOAEL = 17.5 mg/kg/day based on
                                  FQPA SF = 1X                                 decreased body weight and body
                                                                               weight gains in females and
                                                                               hepatocellular vacuolation in
                                                                               males.
----------------------------------------------------------------------------------------------------------------
Dermal short- and intermediate-   Oral study NOAEL =    LOC for MOE = 100     Developmental Neurotoxicity in
 term (1 to 30 days; 1 to 6        10 mg/kg/day                                rat.
 months).                         UFA = 10X                                   LOAEL = 45 mg/kg/day based on
                                  UFH = 10X                                    decreased body weight and body
                                  DAF = 10%                                    weight gains in offspring,
                                  FQPA SF = 1X                                 decreased early pup survival on
                                                                               PND 0-1, and decreased startle
                                                                               response on PND 20/60 in males.
----------------------------------------------------------------------------------------------------------------
Dermal long-term (greater than 6  Dermal (or oral)      LOC for MOE = 100     Chronic Toxicity/Carcinogenicity
 months).                          study NOAEL = 7.1                           Study in rats.
                                   mg/kg/day                                  LOAEL = 17.5 mg/kg/day based on
                                  UFA = 10X                                    decreased body weight and body
                                  UFH = 10X                                    weight gains in females and
                                  DAF = 10%                                    hepatocellular vacuolation in
                                  FQPA SF = 1X                                 males.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30    Oral study NOAEL =    LOC for MOE = 100     Developmental Neurotoxicity in
 days).                            10 mg/kg/day                                rat.
                                   Inhalation toxicity                        LOAEL = 45 mg/kg/day based on
                                   assumed to be                               decreased body weight and body
                                   equivalent to oral                          weight gains in offspring,
                                   toxicity                                    decreased early pup survival on
                                  UFA = 10X                                    PND 0-1, and decreased startle
                                  UFH = 10X                                    response on PND 20/60 in males.
                                  FQPA SF = 1X
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal,                      Classification: ``Not likely to be carcinogenic to humans''.
 inhalation).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). DAF = Dermal Absorption Factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetamiprid, EPA considered exposure under the petitioned-
for tolerances as well as all existing acetamiprid tolerances in 40 CFR
180.578. EPA assessed dietary exposures from acetamiprid 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.
    Such effects were identified for acetamiprid. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, the acute dietary exposure assessment was
unrefined and used tolerance-level residues and 100 percent crop
treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, the chronic dietary
exposure assessment was slightly refined using PCT information for some
commodities. Aside from these commodities, the analyses were based on
tolerance-level residues and the assumption of 100 PCT. In addition,
conservative default processing factors were used for many processed
commodities, while empirical processing factors were used for a limited
number of processed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that acetamiprid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. 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 and 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 Agency estimated the PCT for existing uses as follows:
    In the acute assessment, 100 PCT was assumed for all commodities.
    In the chronic assessment, the PCT estimates used were as follows:
1% of almonds, 30% of apples, 10% of apricots, 5% of asparagus, 10% of
blueberries, 5% of broccoli, 10% of cabbage, 5% of caneberries, 15% of
cantaloupes, 10% of cauliflower, 40% of celery, 5% of cherries, 5% of
cotton, 2.5% of cucumbers, 2.5% of grapefruit, 2.5% of grapes, 2.5% of
lemons, 15% of lettuce, 1% of nectarines, 2.5% of onions, 2.5% of
oranges, 5% of peaches, 35% of pears, 1% of pecans, 5% of peppers, 5%
of pistachios, 2.5% plums/prunes, 2.5% of potatoes, 5% of pumpkins, 10%
of spinach, 5% of squash, 30% of strawberries, 1% of sweet corn, 5% of
tomatoes, 15% of walnuts, and 5% of watermelons.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    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 acetamiprid 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 acetamiprid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of acetamiprid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC) and Provisional
Cranberry Model, the estimated drinking water concentrations (EDWCs) of
acetamiprid for acute exposures are estimated to be 88.1 parts per
billion (ppb) in surface water and 211 ppb in ground water, and for
chronic exposures are estimated to be 12.7 ppb in surface water and 175
ppb in ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 211 ppb was used to assess
the contribution from drinking water. For the chronic dietary risk
assessment, the water concentration of value 175 ppb was used to assess
the contribution from 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).
    Acetamiprid is currently registered for the following uses that
could result in residential exposures: Gardens and trees, spot-on pet
treatment, fly control, indoor crack/crevice, mattresses for bed bug
control, and animal barns. EPA assessed residential exposure using the
following assumptions: Residential handler dermal and inhalation
exposure are expected to occur from the use of the registered
acetamiprid formulations on ornamentals, vegetables, and fruit trees.
All residential handler exposures are expected to be short-term in
duration. Residential handler dermal exposure is expected to occur from
the registered acetamiprid spot-on product when applied to dogs.
Inhalation exposure from spot-on products is considered to be
negligible. Residential handler

dermal and inhalation exposures from applications to indoor
environments was not assessed based on current Agency policy because
the labels for the products that are used in indoor environments
require personal protective equipment (PPE). Residential handler
exposure from the fly bait use was not assessed, as exposures are
expected to be insignificant due to incorporation of acetamiprid in the
glue.
    There is the potential for post-application exposure for
individuals exposed as a result of being in an environment that has
been treated with acetamiprid. The quantitative risk assessment for
residential post-application exposures is based on the following
scenarios: Short-term dermal exposure to gardens (gardens, trees,
indoor plants); short-, intermediate-, and long-term dermal and
incidental oral exposure to the dog spot-on treatment; short-term
dermal, inhalation, and incidental oral exposure from the indoor crack
and crevice and bed bug mattress uses; and short-term dermal and
incidental oral exposure from the fly bait granule use. Post-
application dermal exposures from foundation, perimeter, and spot
treatments outdoors, along with post-application inhalation exposure,
are considered negligible and were not assessed. Acetamiprid is also
registered for use as a termiticide. A quantitative assessment for
potential post-application inhalation and dermal exposure resulting
from a commercial termiticide application in a residential setting is
not needed, as all applications are made to the soil/foundation around/
underneath a structure. In this case, exposure to acetamiprid vapors is
not expected. Additionally, EPA believes that inhalation and dermal
exposure to acetamiprid from bed bug treatments (applied directly to
the space where people are living vs. application to the foundation/
structure) would be protective of the termiticide uses of acetamiprid.
    The lifestages selected for each post-application scenario are
based on the Agency's 2012 Residential SOPs. While not the only
lifestage potentially exposed for these post-application scenarios, the
lifestage that is included in the quantitative assessment, (i.e.,
Children (1 < 2 years), children (3 < 6 years), children (6 < 12
years), adult), is health protective for the exposures and risk
estimates for any other potentially exposed lifestage.
    Based on the proposed uses, short- and intermediate-term exposures
are expected for the proposed use profile. Since the same endpoint and
POD were selected for short- and intermediate-term durations, short-
term exposure and risk estimates are considered protective of potential
intermediate-term exposure and risk.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 acetamiprid to share a common mechanism of
toxicity with any other substances, and acetamiprid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetamiprid 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. Evidence of qualitative
susceptibility was observed in the 2-generation reproductive study,
with the offspring effects (significant reductions in pup weights,
reduction in litter size and viability, significant delays in weaning
indices and the age to attain vaginal opening and preputial separation)
considered more severe than the decrease in parental body weights.
Qualitative susceptibility was also seen in the DNT with offspring
effects (decreased body weight, pre-weaning survival, and startle
response) occurring in the presence of marginal parental body weight
decreases.
    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 acetamiprid is complete.
    ii. Acetamiprid produced signs of neurotoxicity in the high dose
groups in the acute and developmental neurotoxicity studies in rats and
the subchronic toxicity study in mice. However, no neurotoxic findings
were reported in the subchronic neurotoxicity study in rats.
Additionally, there are clear NOAELs identified for the effects
observed in the toxicity studies. The doses and endpoints selected for
risk assessment are protective and account for all toxicological
effects observed in the database.
    iii. No quantitative or qualitative evidence of increased
susceptibility of fetuses to in utero exposure to acetamiprid was
observed in the developmental toxicity study in either rats or rabbits.
Although increased qualitative susceptibility was seen in the
reproduction toxicity and the DNT study, the degree of concern for the
effects is low. There are clear NOAELs for the offspring effects and
regulatory doses were selected to be protective of these effects. No
other residual uncertainties were identified with respect to
susceptibility. The endpoints and doses selected for acetamiprid are
protective of adverse effects in both offspring and adults.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues, and the chronic dietary
exposure assessment was slightly refined using PCT information for some
commodities. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
acetamiprid 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 acetamiprid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to acetamiprid will occupy 89% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
acetamiprid from food and water will utilize 48% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
    Long-term aggregate risk assessments were conducted to assess risks
for adults and children and include exposure through oral (children
only) and dermal routes. The oral and dermal endpoints for long-term
exposure durations are the same (decreased body weight and body weight
gains), and therefore exposures from these pathways are aggregated. In
accordance with the FQPA, the combined exposure from these pathways is
added to the background dietary exposure from the chronic dietary
exposure assessment.
    The Agency selected only the most conservative, or worst case,
scenarios for each lifestage. For both adults and children, worst-case
long-term scenarios reflect post-application exposure to pets treated
with spot-on products. As the LOCs are identical for all routes of
exposure, and since the POD for all routes of exposure is derived from
an oral study, the long-term aggregate MOEs were calculated by adding
the exposures and dividing the POD (7.1 mg/kg) by the sum of the
exposures.
    EPA has concluded the combined long-term food, water, and
residential exposures result in aggregate MOEs of 110 for children 1 to
less than 2 years old and 360 for adults. Because EPA's level of
concern for acetamiprid is a MOE of 100 or below, these MOEs are not of
concern.
    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).
    Acetamiprid 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 acetamiprid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 180 for adults,
460 for children 6 to less than 12 years old, 340 for children 3 to
less than 6 years old, and 130 for children 1 to less than 2 years old.
Because EPA's level of concern for acetamiprid is a MOE of 100 or
below, these MOEs are not of concern.
    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).
    An intermediate-term adverse effect was identified, and
intermediate-term exposure is expected; however, since the same
endpoint and POD were selected for short- and intermediate-term
durations, short-term exposure and risk estimates are considered
protective of potential intermediate-term exposure and risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, acetamiprid is 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 acetamiprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Approved tolerance enforcement methods for acetamiprid residues in
crops are available, including methods using gas chromatography with
electron capture detection (GC/ECD) analysis for vegetables and non-
citrus fruits, high-performance liquid chromatography with ultraviolet
detection (HPLC/UV) analysis for citrus fruits only, and HPLC with
tandem mass spectrometric detection (LC/MS/MS) analysis for vegetables
and non-citrus fruits. An approved HPLC/UV tolerance enforcement method
for livestock matrices is available.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The following table summarizes the tolerances being established by
this document and the corresponding Codex tolerances. The U.S.
tolerance in Cottonseed subgroup 20C is harmonized with the Codex MRL
in cotton seed. The U.S. tolerance in Fruit, stone, group 12-12 is
harmonized with the Codex MRL in cherry, which has the highest MRL of
the individual group 12-12 commodities with Codex MRLs. EPA is not able
to harmonize the other tolerances with Codex MRLs because the U.S.
tolerances are higher. Establishing a U.S. tolerance at a lower level
to harmonize with Codex would put U.S. growers at risk of having
violative residues despite legal use of the pesticide according to the
label.

----------------------------------------------------------------------------------------------------------------
  U.S. tolerances established in this rulemaking (40 CFR Sec.                         Codex
                           180.578)                            -------------------------------------------------
---------------------------------------------------------------
                                                   Tolerance                Commodity               MRL (mg/kg)
                  Commodity                          (ppm)
----------------------------------------------------------------------------------------------------------------
Brassica, leafy greens, subgroup 4-16B........              15  Chinese broccoli................             0.4
Celtuce.......................................               3  ................................  ..............
Cottonseed subgroup 20C.......................             0.7  Cotton seed.....................             0.7
Florence, fennel, fresh leaves and stalk......               3  ................................  ..............
Fruit, stone, group 12-12.....................             1.5  Cherry..........................             1.5
                                                                Nectarine, peach................             0.7
                                                                Dried prune.....................             0.6
                                                                Plum............................             0.2
Kohlrabi......................................             1.2  ................................  ..............
Leaf petiole vegetable subgroup 22B...........               3  Celery..........................             1.5
Leafy greens subgroup 4-16A...................               3  ................................  ..............
Nut, tree, group 14-12........................             0.1  Tree nuts.......................            0.06
Rapeseed subgroup 20A.........................            0.01  ................................  ..............
Tropical and subtropical, medium to large                  0.5  ................................  ..............
 fruit, smooth, inedible peel, subgroup 24B.
Vegetable, brassica, head and stem, group 5-16             1.2  Broccoli, cauliflower...........             0.4
                                                                Cabbage.........................             0.7
----------------------------------------------------------------------------------------------------------------

C. Response to Comments

    One commenter stated that ``EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
support granting of the pesticide petitions.'' The commenter does not
indicate what additional data might be necessary, why the commenter
questions the sufficiency of the available data, or what about the
Agency's findings is unsupported. Contrary to the commenter's position,
the Agency has in fact fully evaluated all the data submitted on
acetamiprid and determined that the toxicological and exposure
databases on acetamiprid are complete, i.e., they do not contain any
data gaps at this time, and dietary and residential exposure and risk
have not been underestimated. Taking all that information into
consideration, EPA has concluded that the tolerances for acetamiprid
are safe.
    The other comments submitted raised more general concerns about the
use of pesticides and questioned a separate tolerance exemption.
Neither raise issues relevant to this tolerance rulemaking.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing some of the tolerances at different levels than
petitioned for in order to be consistent with the Agency's rounding
class practice, which is based on the rounding procedures of the
Organisation for Economic Co-operation and Development. EPA corrected
the commodity definition for Fennel, Florence, fresh leaves and stalk.
Finally, EPA is removing the existing tolerance in Plum, prune, dried,
because it is no longer needed with the establishment of the tolerance
in Fruit, stone, group 12-12; although not requested in the original
petition, the need to remove this tolerance was confirmed in subsequent
correspondence with the petitioner.

V. Conclusion

    Therefore, tolerances are established for residues of acetamiprid
in or on Brassica, leafy greens, subgroup 4-16B at 15 ppm; Celtuce at 3
ppm; Cottonseed subgroup 20C at 0.7 ppm; Fennel, Florence, fresh leaves
and stalk at 3 ppm; Fruit, stone, group 12-12 at 1.5 ppm; Kohlrabi at
1.2 ppm; Leaf petiole vegetable subgroup 22B at 3 ppm; Leafy greens
subgroup 4-16A at 3 ppm; Nut, tree, group 14-12 at 0.1 ppm; Rapeseed
subgroup 20A at 0.01 ppm; Tropical and subtropical, medium to large
fruit, smooth, inedible peel, subgroup 24B at 0.5 ppm; and Vegetable,
brassica, head and stem, group 5-16 at 1.2 ppm.
    Additionally, the following existing tolerances are removed as
unnecessary due to the establishment of the above tolerances: Brassica,
head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B;
Canola, seed; Cotton, undelinted seed; Fruit, stone, group 12, except
plum, prune; Mustard, seed; Nut, tree, group 14; Pistachio; Plum,
prune, dried; Plum, prune, fresh; Turnip greens; and Vegetable, leafy,
except brassica, group 4.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies tolerances under FFDCA section
408(d) 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 action has been
exempted from review under Executive Order 12866, this action 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action 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 FFDCA section 408(d), such as the tolerances 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: January 24, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.578, amend the table in paragraph (a)(1) as follows:
0
a. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and
``Brassica, leafy greens, subgroup 5B'';
0
b. Add alphabetically the entry ``Brassica, leafy greens, subgroup 4-
16B'';
0
c. Remove the entry for ``Canola, seed'';
0
d. Add alphabetically the entries ``Celtuce'' and ``Cottonseed subgroup
20C'';
0
e. Remove the entry for ``Cotton, undelinted seed'';
0
f. Add alphabetically the entries ``Fennel, florence, fresh leaves and
stalk'' and ``Fruit, stone, group 12-12'';
0
g. Remove the entry for ``Fruit, stone, group 12, except plum, prune'';
0
h. Add alphabetically the entries ``Kohlrabi''; ``Leaf petiole
vegetable subgroup 22B''; and ``Leafy greens subgroup 4-16A'';
0
i. Remove the entries for ``Mustard, seed'' and ``Nut, tree, group
14'';
0
j. Add alphabetically the entry ``Nut, tree, group 14-12'';
0
k. Remove the entries for ``Pistachio''; ``Plum, prune, dried''; and
``Plum, prune, fresh'';
0
l. Add alphabetically the entries ``Rapeseed subgroup 20A'' and
``Tropical and subtropical, medium to large fruit, smooth, inedible
peel, subgroup 24B'';
0
m. Remove the entry for ``Turnip greens'';
0
n. Add alphabetically the entry ``Vegetable, brassica, head and stem,
group 5-16''; and
0
o. Remove the entry for ``Vegetable, leafy, except brassica, group 4''.
    The revisions and additions read as follows:

Sec.  180.578  Acetamiprid; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Brassica, leafy greens, subgroup 4-16B......................          15

                                * * * * *
Celtuce.....................................................           3

                                * * * * *
Cottonseed subgroup 20C.....................................         0.7
Fennel, florence, fresh leaves and stalk....................           3

                                * * * * *
Fruit, stone, group 12-12...................................         1.5

                                * * * * *
Kohlrabi....................................................         1.2
Leaf petiole vegetable subgroup 22B.........................           3
Leafy greens subgroup 4-16A.................................           3
Nut, tree, group 14-12......................................         0.1

                                * * * * *
Rapeseed subgroup 20A.......................................        0.01

                                * * * * *
Tropical and subtropical, medium to large fruit, smooth,             0.5
 inedible peel, subgroup 24B................................
Vegetable, brassica, head and stem, group 5-16..............         1.2

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-02038 Filed 2-13-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Rules and Regulations]
[Pages 40959-40961]
[FR Doc No: 2021-16110]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0601; FRL-8689-02-R9]

Air Plan Revision; Limited Approval and Limited Disapproval;
California; Yolo-Solano Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing the
limited approval and limited disapproval of a revision to the Yolo-
Solano Air Quality Management District (YSAQMD) portion of the
California State Implementation Plan (SIP). This revision concerns
emissions of volatile organic compounds (VOCs) from solvent cleaning
and degreasing operations. Under the authority of the Clean Air Act
(CAA or the Act), this action simultaneously approves a local rule that
regulates these emission sources and directs California to correct rule
deficiencies.

DATES: This rule will be effective on August 30, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket No. EPA-R09-OAR-2018-0601. All documents in the docket are
listed on the https://www.regulations.gov website. 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 through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information. If you need assistance
in a language other than English or if you are a person with
disabilities who needs a reasonable accommodation at no cost to you,
please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section.

FOR FURTHER INFORMATION CONTACT: Arnold Lazarus, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and the EPA's Response
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On February 25, 2021 (86 FR 11480), the EPA proposed a limited
approval and limited disapproval of the following rule that was
submitted for incorporation into the California SIP.

----------------------------------------------------------------------------------------------------------------
             Local agency                   Rule #             Rule title             Revised        Submitted
----------------------------------------------------------------------------------------------------------------
YSAQMD................................            2.31  Solvent Cleaning and          04/12/2017      08/09/2017
                                                         Degreasing.
----------------------------------------------------------------------------------------------------------------

    We proposed a limited approval because we determined that this rule
improves the SIP and is largely consistent with the relevant CAA
requirements. We simultaneously proposed a limited disapproval because
the following rule provision conflicts with section 110 and part D of
the Act. The provision at section 110.6 of the rule exempts solvent
degreasing operations that are subject to National Emission Standards
for Hazardous Air Pollutants (NESHAP) requirements at 40 CFR part 63
Subpart T regulating halogenated solvent cleaning.
    CAA Section 182(b)(2) (``Reasonably available control technology'')
states: ``The State shall submit a revision to the applicable
implementation plan to include provisions to require the implementation
of reasonably available control technology . . . .'' While the YSAQMD
has been delegated the authority to enforce the requirements in 40 CFR
63 Subpart T, this type of delegation of authority to a district or
state does not place those requirements or its emission limitations
into the SIP. Thus, this rule fails to implement RACT for halogenated
solvent cleaning in an enforceable SIP regulation. Our proposed action
contains more information on the basis for this rulemaking and on our
evaluation of the submittal.

II. Public Comments and the EPA's Response

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received one comment that was supportive of the
proposed action.

III. EPA Action

    No comments were submitted that change our assessment of the rule
as described in our proposed action. Therefore, as authorized in
sections 110(k)(3) and 301(a) of the Act, the EPA is finalizing a
limited approval of the submitted rule. This action incorporates the
submitted rule into the California SIP, including those provisions
identified as deficient. As authorized under section 110(k)(3) and
301(a), the EPA is simultaneously finalizing a limited disapproval of
the rule. As a result, the EPA must promulgate a federal implementation
plan under section 110(c) unless we approve subsequent SIP revisions
that correct the rule deficiencies within 24 months. In addition, the
offset sanction in CAA section 179(b)(2) will be imposed 18 months
after the effective date of this action, and the highway funding
sanction in CAA section 179(b)(1) six months after the offset sanction
is imposed. A sanction will not be imposed if the EPA determines that a
subsequent SIP submission corrects the identified deficiencies before
the applicable deadline.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
YSAQMD rules described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders
can be found at http://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the National Government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction, and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA lacks the discretionary authority to address environmental
justice in this rulemaking.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 28, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: July 22, 2021.
Deborah Jordan,
Acting Regional Administrator, Region IX.

    For reasons set forth in the preamble, EPA amends Part 52, Chapter
I, Title 40 of the Code of Federal Regulations as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(442)(i)(F)(4) and
(c)(503)(i)(D) to read as follows:

Sec.  52.220  Identification of plan-in part.

* * * * *
    (c) * * *
    (442) * * *
    (i) * * *
    (F) * * *
    (4) Previously approved on April 28, 2015 in paragraph
(c)(442)(i)(F)(2) of this section and now deleted with replacement in
(c)(503)(i)(D)(1), Rule 2.31, ``Solvent Cleaning and Degreasing,''
revised on May 8, 2013.
* * * * *
    (503) * * *
    (i) * * *
    (D) Yolo-Solano Air Quality Management District.
    (1) Rule 2.31, ``Solvent Cleaning and Degreasing,'' revised on
April 12, 2017.
    (2) [Reserved]
* * * * *

[FR Doc. 2021-16110 Filed 7-29-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2106-2108]
[FR Doc No: 2012-529]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66121; File No. SR-NASDAQ-2012-001]

 Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Routing Fees

January 9, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 3, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the NASDAQ. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The NASDAQ Stock Market LLC proposes to modify Rule 7050, governing
pricing for NASDAQ members using the NASDAQ Options Market (``NOM''),
NASDAQ's facility for executing and routing standardized equity and
index options.
    The text of the proposed rule change is set forth below. Proposed
new text is italicized and deleted text is in brackets.
* * * * *

7050. NASDAQ Options Market

    The following charges shall apply to the use of the order execution
and routing services of the NASDAQ Options Market for all securities.
* * * * *
    (4) Fees for routing contracts to markets other than the NASDAQ
Options Market shall be assessed as provided below. The current fees
and a historical record of applicable fees shall be posted on the
NasdaqTrader.com Web site.

----------------------------------------------------------------------------------------------------------------
                     Exchange                         Customer          Firm             MM         Professional
----------------------------------------------------------------------------------------------------------------
BATS.............................................       $0.[36]50           $0.55           $0.55      $0.[48]50
BOX..............................................            0.06            0.55            0.55       0.06
CBOE.............................................            0.06            0.55            0.55       0.26
CBOE orders greater than 99 contracts in NDX, MNX            0.24            0.55            0.55       0.26
 ETFs, ETNs & HOLDRs.............................
C2...............................................            0.50            0.55            0.55       0.51
ISE..............................................            0.06            0.55            0.55       0.24
ISE Select Symbols*..............................            0.18            0.55            0.55       0.34
NYSE Arca Penny Pilot............................            0.50            0.55            0.55       0.50
NYSE Arca Non Penny Pilot........................            0.06            0.55            0.55       0.06
NYSE AMEX........................................            0.06            0.55            0.55       0.26
PHLX (for all options other than PHLX Select                 0.06            0.55            0.55       0.26
 Symbols)........................................
PHLX Select Symbols**............................            0.30            0.55            0.55       0.46
----------------------------------------------------------------------------------------------------------------
* These fees are applicable to orders routed to ISE that are subject to Rebates and Fees for Adding and Removing
  Liquidity in Select Symbols. See ISE's Schedule of Fees for the complete list of symbols that are subject to
  these fees.
** These fees are applicable to orders routed to PHLX that are subject to Rebates and Fees for Adding and
  Removing Liquidity in Select Symbols. See PHLX's Fee Schedule for the complete list of symbols that are
  subject to these fees.

* * * * *
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaq.cchwallstreet.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NASDAQ proposes to modify Rule 7050 governing fees assessed for
option orders entered into NOM but routed to and executed on away
markets (``Routing Fees''). Specifically, NASDAQ is proposing to amend
its Customer and Professional Routing Fees for orders routed to the
BATS Exchange, Inc. (``BATS'').
    The Exchange currently assesses the following Routing Fees to route
orders to BATS: a Customer is assessed $0.36 per contract; a Firm is
assessed $0.55 per contract; a Market Maker is assessed $0.55 per
contract; and a Professional is assessed $0.48 per contract. The
Exchange proposes to amend the Customer and Professional Routing Fees
to BATS to $0.50 per contract. The other BATS Routing Fees for Firms
and Market Makers would remain the same. Recently, BATS announced that
it would amend its customer and professional fees to remove liquidity
to $0.44 per contract on January 3, 2012.\3\ The Exchange is proposing
to amend its Customer and Professional Routing Fees to BATS to $0.50
per contract to recoup this fee.
---------------------------------------------------------------------------

    \3\ See BATS (BZX) Exchange Fee Schedule. See also BATS Options
Exchange Pricing Update Effective January 3, 2012 (dated December
15, 2011).
---------------------------------------------------------------------------

    In addition, NASDAQ Options Services LLC (``NOS''), a member of the
Exchange, is the Exchange's exclusive order router. Each time NOS
routes to away markets NOS is charged a $0.06 clearing fee and, in the
case of certain exchanges, a transaction fee is also charged in certain
symbols, which are passed through to the Exchange. The Exchange is
proposing this amendment in order to recoup clearing and transaction
charges incurred by the Exchange when Customer and Professional orders
are routed to BATS. The Exchange proposes to recoup the $0.44 per
contract customer and professional taker fee for option orders that are
routed to BATS along with the $0.06 clearing fee which is incurred by
the Exchange, as explained herein.
    As with all fees, the Exchange may adjust these Routing Fees in
response to competitive conditions by filing a new proposed rule
change.
2. Statutory Basis
    NASDAQ believes that the proposed rule changes are consistent with
the provisions of Section 6 of the Act,\4\ in general, and with Section
6(b)(4) of the Act,\5\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which NASDAQ operates or controls.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that this fee is reasonable because it seeks
to recoup costs that are incurred by the Exchange when routing Customer
and Professional orders to BATS on behalf of its members. Each
destination market's transaction charge varies and there is a standard
clearing charge for each transaction incurred by the Exchange. The
Exchange believes that the proposed Routing Fee would enable the
Exchange to recover the customer and professional taker fees assessed
by BATS, plus clearing fees for the execution of Customer and
Professional orders. The Exchange also believes that the proposed
Routing Fee is equitable and not unfairly discriminatory because it
would be uniformly applied to all Customers and Professionals.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\6\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2012-001 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2012-001. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the

proposed rule change between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2012-001 and should
be submitted on or before February 3, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-529 Filed 1-12-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Notices]
[Page 72498]
[DOCID:fr28no08-100]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1808-DR]

Kansas; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Kansas (FEMA-1808-DR), dated October 31, 2008, and
related determinations.

DATES: Effective Date: November 18, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Thomas A. Hall,
of FEMA is appointed to act as the Federal Coordinating Officer for
this declared disaster.
    This action terminates my appointment of Michael L. Karl as Federal
Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-28295 Filed 11-26-08; 8:45 am]

BILLING CODE 9111-23-P