[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Proposed Rules]
[Page 16365-16370]
[DOCID:fr01ap10-23]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2009-N-0458]
RIN 0910-AG29

Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA) is proposing to amend
the regulations on premarket approval of medical devices to include
requirements relating to the submission of information on pediatric
subpopulations that suffer from the disease or condition that a device
is intended to treat, diagnose, or cure. Elsewhere in this issue of the
Federal Register, we are publishing a companion direct final rule. This

proposed rule will provide a procedural framework to finalize the rule
in the event we receive significant adverse comment and withdraw the
direct final rule.

DATES:  Submit electronic or written comments on the proposed rule by
June 15, 2010. Submit electronic or written comments on the information
collection requirements by June 1, 2010.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2009-
N-0458, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and docket number and regulatory information number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Robert Gatling, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1640, Silver Spring, MD 20993, 301-796-
6560.

SUPPLEMENTARY INFORMATION:

I. Why Is This Companion Proposed Rule Being Issued?

    This proposed rule is a companion to a direct final rule regarding
the submission of information on pediatric subpopulations that suffer
from a disease or condition that a device is intended to treat,
diagnose, or cure. The direct final rule is published in the final
rules section of this issue of the Federal Register. The direct final
rule and this companion proposed rule are substantively identical. This
companion proposed rule provides the procedural framework to finalize
the rule in the event that the direct final rule receives any
significant adverse comment and is withdrawn. We are publishing the
direct final rule because we believe the rule is noncontroversial, and
we do not anticipate receiving any significant adverse comments. If no
significant adverse comment is received in response to the direct final
rule, no further action will be taken relating to this proposed rule.
Instead, we will publish a notice within 30 days after the comment
period ends confirming when the direct final rule will go into effect.
    If we receive any significant adverse comment regarding the direct
final rule we will withdraw the direct final rule within 30 days after
the comment period ends and proceed to respond to all of the comments
under this companion proposed rule using our usual notice-and-comment
rulemaking procedures under the Administrative Procedure Act (APA) (5
U.S.C. 552a et seq.). The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. Any
comments received under this companion proposed rule will be considered
as comments regarding the direct final rule and vice versa. We will not
provide additional opportunity for comment.
    A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the APA (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered a significant adverse comment, unless the comment states why
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to part of a rule
and that part can be severed from the remainder of the rule, we may
adopt as final those parts of the rule that are not the subject of a
significant adverse comment.
    In the Federal Register of November 21, 1997 (62 FR 62466), you can
find additional information about FDA's direct final rulemaking
procedures in our guidance document entitled ``Guidance for FDA and
Industry: Direct Final Rule Procedures.'' This guidance document is
available at http://www.fda.gov/RegulatoryInformation/Guidances/
ucm125166.htm.

II. What Is the Background of This Proposed Rule?

    On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (FDAAA)\1\ (Public Law 110-85) amended the Federal Food,
Drug, and Cosmetic Act (the act) by adding, among other things, a new
section 515A of the act (21 U.S.C. 360e-1). Section 515A(a) of the act
requires persons who submit certain medical device applications to
include readily available information providing a description of any
pediatric subpopulations that suffer from the disease or condition that
the device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients. This proposed rule amends FDA's
regulations to implement the requirements of section 515A(a) of the
act.
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    \1\ Title III of FDAAA, which includes new section 515A, is also
known as the Pediatric Medical Device Safety and Improvement Act of
2007.
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    Section 515A(c) of the act states that, for the purposes of that
section, the term ``pediatric subpopulation'' has the meaning given the
term in section 520(m)(6)(E)(ii) of the act (21 U.S.C.
360j(m)(6)(E)(ii)). Section 520(m)(6)(E)(ii) of the act defines the
term ``pediatric subpopulation'' to mean one of the following
populations:
     Neonates;
     Infants;
     Children; or
     Adolescents.
    We have previously issued guidance recommending the age range for
each of the populations included in the term ``pediatric
subpopulation.'' See Premarket Assessment of Pediatric Medical Devices
(May 14, 2004); http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.
    The term ``pediatric patient'' is defined, for purposes of section
520(m)(6)(E)(i) of the act as patients who are 21 years of age or
younger at the time of the diagnosis or treatment. Because no other
definition of ``pediatric patient'' is included in the Pediatric
Medical Device Safety and Improvement Act of 2007, and because the
definition in section 520(m)(6)(E)(i) of the act is consistent with the
definition of pediatric subpopulations in section 520(m)(6)(E)(ii), FDA
has concluded

that the term ``pediatric patient'' in section 515A of the act refers
to patients who are 21 years of age or younger at the time of the
diagnosis or treatment.
    The information submitted under section 515A(a) of the act will
help FDA track the following information that it is required to report
annually to Congress, in accordance with section 515A(a)(3) of the act:
     The number of approved devices for which there is a
pediatric subpopulation that suffers from the disease or condition that
the device is intended to treat, diagnose, or cure;
     The number of approved devices labeled for use in
pediatric patients;
     The number of approved pediatric devices that were
exempted from a review fee under section 738(a)(2)(B)(v) of the act (21
U.S.C. 379j(a)(2)(B)(v)); and
     The review time for each such device.

III. What Applications Are Subject to This Proposed Rule?

    In accordance with the act, these requirements apply to the
following applications when submitted on or after the effective date of
this proposed rule:
     Any request for a humanitarian device exemption (HDE)
submitted under section 520(m) of the act;
     Any premarket approval application (PMA) or supplement to
a PMA submitted under section 515 of the act; and
     Any product development protocol (PDP) submitted under
section 515 of the act.
    If the applicant of a supplement to a PMA has previously submitted
information satisfying these requirements, the applicant may
incorporate that information by reference rather than resubmitting the
same information. However, if additional information has become readily
available to the applicant since the previous submission, the applicant
must submit that information as part of the supplement.
    Many PMAs begin with the submission of one or more PMA modules; see
Premarket Approval Application Modular Review--Guidance for Industry
and FDA Staff, available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm089764.htm. Applicants
who choose to use the modular approach should submit the information
required by section 515A(a) of the act in the final PMA module (i.e.,
the module that includes final clinical data, proposed labeling, and
the summary of safety and effectiveness).

IV. What Does This Proposed Rule Do?

    This proposed rule would implement new section 515A(a) of the act
by amending 21 CFR Part 814, Premarket Approval of Medical Devices, to
include requirements relating to the submission of information on
pediatric subpopulations that suffer from the disease or condition that
a device is intended to treat, diagnose, or cure.

A. What Information Must Be Provided?

    This proposed rule requires each applicant who submits an HDE, PMA,
supplement to a PMA, or PDP to include, if ``readily available,'' a
description of any pediatric subpopulations that suffer from the
disease or condition that the device is intended to treat, diagnose, or
cure, and the number of affected pediatric patients.

B. What Are the Consequences of Not Submitting ``Readily Available''
Information?

    If you do not submit the information required by section 515A(a) of
the act, FDA may not approve your application until you provide the
required information. We intend to contact you during the normal course
of our review to inform you that your submission lacks the information
required by section 515A(a) of the act and by this proposed rule, and
to ask you to amend your application to provide the required
information. If your application has no other deficiencies and
otherwise meets applicable statutory and regulatory requirements for
approval, but still lacks information required by section 515A(a) of
the act, we intend to send you an ``approvable'' letter informing you
that we will approve your application after you provide the information
required by section 515A(a). If your application has other deficiencies
or does not meet all applicable statutory and regulatory requirements
for approval, we intend to send you a ``not approvable'' letter or a
``major deficiency'' letter describing what information or data you
need to provide before FDA can approve your application; the ``not
approvable'' or ``major deficiency'' letter may cite the absence of
515A(a) information in the section listing minor deficiencies. For
additional information concerning the interactive process we will use
during our review, see Guidance for Industry and FDA Staff: Interactive
Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA
Supplements, Original BLAs, and BLA Supplements, available at http://
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm089402.htm. For additional information concerning
``approvable,'' ``not approvable,'' and ``major deficiency'' letters,
see FDA and Industry Actions on Premarket Approval Applications (PMAs):
Effect on FDA Review Clock and Goals, available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm089733.htm.

V. What Is the Legal Authority for This Proposed Rule?

    This proposed rule, if finalized, would amend Sec. Sec.  814.1,
814.2, 814.20, 814.37, 814.39, 814.44, 814.100, 814.104, and 814.116.
FDA's legal authority to modify Sec. Sec.  814.1, 814.2, 814.20,
814.37, 814.39, 814.44, 814.100, 814.104, and 814.116 arises from the
same authority under which FDA initially issued these regulations, the
device and general administrative provisions of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 360e, 360e-1, 360j, and
371).

VI. What Is the Environmental Impact of This Proposed Rule?

    FDA has determined under 21 CFR 25.30(h) and 25.34(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VII. What Is the Economic Impact of This Proposed Rule?

    We have examined the impacts of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
proposed rule is not a significant regulatory action as defined by the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this regulation only requires that some
submissions include a small amount of readily available information,
creating little additional burden, the agency certifies that the
proposed rule will not have a significant

economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
rule to result in any 1-year expenditure that would meet or exceed this
amount.
    We believe that the only costs to industry are those that we
account for in our Paperwork Reduction Act analysis, which immediately
follows this section. The proposed rule does not require additional
clinical research or other costly efforts, and simply requires the
applicant to briefly summarize readily available information that will
have been reviewed by the applicant during the course of its
development of the device and preparation of its application to FDA. We
have also limited the proposed rule to exclude supplements that do not
involve a new intended use; if a supplement does not involve a new
intended use, we do not expect the applicant will have new information
pertinent to the requirement of section 515A(a) of the act and this
rule, and the limitation avoids the needless submission of duplicate
information to FDA. We expect FDA's additional costs will be
inconsequential, as the information required here will be filed and
managed as an integral part of each submission, using existing filing,
storage, and data management systems and processes.

VIII. How Does the Paperwork Reduction Act of 1995 Apply to This
Proposed Rule?

    This proposed rule contains information collection requirements
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown below with an estimate of the annual
reporting burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information. FDA invites comments on: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection techniques, when
appropriate, and other forms of information technology.
    Title: Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure.
    Description: Section 515A(a) of FDAAA requires applicants who
submit certain medical device applications to include readily available
information providing a description of any pediatric subpopulations
that suffer from the disease or condition that the device is intended
to treat, diagnose, or cure, and the number of affected pediatric
patients. The information submitted will allow FDA to track the number
of approved devices for which there is a pediatric subpopulation that
suffers from the disease or condition that the device is intended to
treat, diagnose, or cure; the number of approved devices labeled for
use in pediatric patients; the number of approved pediatric devices
that were exempted from a review fee under section 738(a)(2)(B)(v) of
the act; and the review time for each such device.
    Description of Respondents: These requirements apply to applicants
who submit the following applications when submitted on or after the
effective date of this rule:
     Any request for an HDE submitted under section 520(m) of
the act;
     Any PMA submitted under section 515 of the act;
     Any PDP submitted under section 515 of the act; and
     Any supplement to an HDE, PMA, or PDP that proposes a new
intended use, whether for an adult population or a pediatric
population.
    Burden: FDA estimates the burden of this collection of information
as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.20(b)(3)(i)                                                        25                     1                 25                  4                100
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814.37(b)(2)                                                           10                     1                 10                  4                 40
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814.39(h)                                                              10                     1                 10                  4                 40
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814.104(b)(6)                                                           5                     1                  5                  4                 20
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Totals                                                                                200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    All that is required is to access, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the act and this rule. FDA expects
to receive approximately 40 original PMA/PDP/HDE applications each
year, 5 of which FDA expects to be HDEs. This estimate is based on the
actual average of FDA's receipt of new PMA applications in FY 2007
through FY 2008. The agency estimates that 10 of those 40 original PMA
submissions will fail to provide the required pediatric use information
and their sponsors will therefore be required to submit PMA amendments.
The agency also expects to receive 10 supplements that describe a new
indication for use and will include the pediatric use information
required by 515A(a) of the act and this rule. We believe that because
the rule requires that the applicant organize and submit only

readily available information, no more than 4 hours will be required to
comply with section 515A(a) of the act and this rule. FDA estimates
that the total burden created by this rule is 200 hours.
    We based this estimate on our experience with similar information
collection requirements and on consultations with the Interagency
Pediatric Devices Working Group which includes the Agency for
Healthcare Research and Quality, FDA, National Institutes of Health,
members of the Pediatric Advisory Committee, researchers, healthcare
practitioners, medical device trade associations, and medical device
manufacturers.
    In compliance with the provisions of the Paperwork Reduction Act of
1995 (44 U.S.C. 3507(d)), the agency has submitted the information
collection provisions of this proposed rule to OMB for review. As
provided in 5 CFR 1320.5(c)(1), collections of information in a
proposed rule are subject to the procedures set forth in 5 CFR 1320.10.
Interested persons and organizations may submit comments on the
information collection requirements of this proposed rule (see DATES)
to the Division of Dockets Management (see ADDRESSES).
    At the close of the 60-day comment period, FDA will review the
comments received, revise the information collection provisions as
necessary, and submit these provisions to OMB for review. FDA will
publish a notice in the Federal Register when the information
collection provisions are submitted to OMB, and an opportunity for
public comment to OMB will be provided at that time. Prior to the
effective date of the direct final rule, FDA will publish a notice in
the Federal Register of OMB's decision to approve, modify, or
disapprove the information collection provisions. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

IX. What Are the Federalism Impacts of This Proposed Rule?

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the rule does not contain policies that 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. Accordingly, we have concluded that
the rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.

X. How Do You Submit Comments on This Rule?

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this proposed
rule. Submit a single copy of electronic comments or two paper copies
of any mailed comments, except that individuals may submit one paper
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
814 is proposed to be amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    1. The authority citation for 21 CFR part 814 continues to read as
follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
    2. In Sec.  814.1, revise paragraph (a) to read as follows:

Sec.  814.1   Scope.

    (a) This section implements sections 515 and 515A of the act by
providing procedures for the premarket approval of medical devices
intended for human use.
* * * * *
    3. Revise Sec.  814.2 to read as follows:

Sec.  814.2   Purpose.

    The purpose of this part is to establish an efficient and thorough
device review process--
    (a) To facilitate the approval of PMAs for devices that have been
shown to be safe and effective and that otherwise meet the statutory
criteria for approval;
    (b) To ensure the disapproval of PMAs that have not been shown to
be safe and effective or that do not otherwise meet the statutory
criteria for approval; and
    (c) To ensure PMAs include readily available information concerning
actual and potential pediatric uses of medical devices.
    4. In Sec.  814.20, revise paragraph (b)(3)(i) to read as follows:

Sec.  814.20   Application.

* * * * *
    (b) * * *
    (3) * * *
    (i) Indications for use. (A) A general description of the disease
or condition the device will diagnose, treat, prevent, cure, or
mitigate, including a description of the patient population for which
the device is intended.
    (B) Information concerning uses in pediatric patients who are 21
years of age or younger: The application must include the following
information, if readily available:
    (1) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
    (2) The number of affected pediatric patients.
* * * * *
    5. In Sec.  814.37, revise the section heading and paragraph (b) to
read as follows:

Sec.  814.37   PMA amendments and resubmitted PMAs.

* * * * *
    (b)(1) FDA may request the applicant to amend a PMA or PMA
supplement with any information regarding the device that is necessary
for FDA or the appropriate advisory committee to complete the review of
the PMA or PMA supplement.
    (2) FDA may request the applicant to amend a PMA or PMA supplement
with information concerning pediatric uses as required under Sec.
814.20(b)(3)(i).
* * * * *
    6. In Sec.  814.39, add paragraph (h) to read as follows:

Sec.  814.39   PMA supplements.

* * * * *
    (h) The application must include the following information, if
readily available:
    (1) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
    (2) The number of affected pediatric patients who are 21 years of
age or younger.
    (3) If information concerning the device that is the subject of the
supplement was previously submitted under Sec.  814.20(b)(3)(i), that
information may be incorporated by reference to the application or
submission that contains

the information. However, if additional information required under
Sec.  814.20(b)(3)(i) has become readily available to the applicant
since the previous submission, the applicant must submit that
information as part of the supplement.
    7. In Sec.  814.44, redesignate paragraphs (e)(1)(ii) through
(e)(1)(iv) as paragraphs (e)(1)(iii) through (e)(1)(v), respectively,
and add new paragraph (e)(1)(ii) to read as follows:

Sec.  814.44   Procedures for review of a PMA.

* * * * *
    (e) * * *
    (1) * * *
    (ii) The submission of additional information concerning potential
pediatric uses required by Sec.  814.20(b)(3)(i) that is readily
available to the applicant;
* * * * *
    8. Amend Sec.  814.100 as follows:
    a. Redesignate paragraphs (b) through (e) as paragraphs (d) through
(g), respectively;
    b. Redesignate paragraph (a) as paragraph (b), and remove the first
sentence of redesignated paragraph (b); and
    c. Add new paragraphs (a) and (c) to read as follows:

Sec.  814.100   Purpose and scope.

    (a) This subpart H implements sections 515A and 520(m) of the act.
* * * * *
    (c) Section 515A of the act is intended to ensure the submission of
readily available information concerning actual and potential pediatric
uses of medical devices.
* * * * *
    9. Amend Sec.  814.104 as follows:
    a. Revise the last sentence of paragraph (b)(4)(ii);
    b. Revise the last sentence of paragraph (b)(5); and
    c. Add paragraph (b)(6) to read as follows:

Sec.  814.104   Original applications.

* * * * *
    (b) * * *
    (4) * * *
    (ii) * * * The effectiveness of this device for this use has not
been demonstrated.
    (5) * * * If the amount charged is $250 or less, the requirement
for a report by an independent certified public accountant or an
attestation by a responsible individual of the organization is waived;
and
    (6) Readily available information concerning actual and potential
pediatric uses of the device, as required by Sec.  814.20(b)(3)(i).
* * * * *
    10. In Sec.  814.116, redesignate paragraphs (c)(2) through (c)(4)
as paragraphs (c)(3) through (c)(5), respectively, and add new
paragraph (c)(2) to read as follows:

Sec.  814.116   Procedures for review of an HDE.

* * * * *
    (c) * * *
    (2) The submission of additional information concerning potential
pediatric uses required by Sec.  814.20(b)(3)(i) that is readily
available to the applicant;
* * * * *

    Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7192 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: July 7, 2006 (Volume 71, Number 130)]
[Notices]
[Page 38637]
[DOCID:fr07jy06-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-365-000; Docket No. RP06-231-002]

Columbia Gas Transmission Corporation; Norstar Operating, LLC v.
Columbia Gas Transmission Corporation; Notice of Technical Conference

June 29, 2006.
    Take notice that the Commission will convene a technical conference
in reference to the above-captioned proceeding on Tuesday, July 25,
2006, at 9 a.m. (EDT), in a room to be designated at the offices of the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's June 21, 2006 order in this proceeding directed
that a technical conference be held to address the technical,
engineering and operational issues raised by Columbia Gas Transmission
Corporation's (Columbia) proposed gas quality specifications filed in
Docket No. RP06-365-000.\1\ The order also found that Columbia's filing
in Docket No. RP06-231-002 revising section 25.5(e) of its General
Terms and Conditions should be addressed at the technical conference.
---------------------------------------------------------------------------

    \1\[thinsp]Columbia Gas Transmission Corporation, 115 FERC
][thinsp]61,351 (2006).
---------------------------------------------------------------------------

    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    All interested persons are permitted to attend. For further
information please contact David Faerberg at<PHONE_NUMBER> or e-mail
<EMAIL_ADDRESS>

Magalie R. Salas,
Secretary.
 [FR Doc. E6-10614 Filed 7-6-06; 8:45 am]

BILLING CODE 6717-01-P


Laboratory Name: Laboratory ID:

* Lab Sample ID: Sample collection time:

* PWS ID: * Sample collection date:

* Facility ID: Turbidity ( NTU):

* Sample Collection Point ID:

* Initial precision and recovery ( IPR) Method blank Field ( monitoring) sample Ongoing precision and recovery ( OPR) Matrix spike ( MS) Proficiency testing ( PT)

* Estimated number spiked: Crypto Giardia Spiking time:

* Sample volume spiked ( L): Spiking date:

Spiking suspension ID: Spiking analyst:

Filter type ( circle one): Envirochek Envirochek HV Filta Max CrypTest Other ( specify)

Did filter clog ( circle one): Yes No Filter lot number:

* Number of filter( s) used?: Filtration time:

* Volume filtered ( mL): Filtration date:

Elution procedure ( circle one): Wrist shaker Filta Max wash station Stomacher Backflush/ sonication Elution buffer: Elution time:

Elution buffer lot number: Elution date:

Elution buffer expiration date: Elution analyst:

Procedure ( circle one): Centrifugation Filta Max concentrator Other ( specify)

* Pellet volume after concentration ( mL): Concentration analyst:

* Total volume of resuspended concentrate ( mL): IMS analyst:

* Volume of resuspended concentrate transferred to IMS ( mL): Slide prepartion time:

Number of subsamples processed through entire method: Slide preparation date:

IMS lot number: Slide preperation analyst:

IMS system ( circle one): Dynal GC Combo Dynal anti Crypto Other ( specify)

Slides ( circle one): Meridian Dynal Waterborne Other ( specify)

Detection kit ( circle one): Merifluor Crypt a glo Giardi a glo Aqua glo Other ( specify)

Staining time:

Detection kit lot number: Staining date:

Staining analyst:

Comments:

* = data entered into LT2 Data Collection System Concentration, IMS, and Slide Preparation Slide Staining ( must be completed within 72 hours of application of sample to the slide) Sample Spiking Information ( for IPR, OPR, MS, and PT samples only) Method 1622/ 1623 Bench Sheet Sample Identification Information Sample Filtration Sample Elution ( must be performed within 96 hours of sample collection/ filtration) Sample type ( circle one):

( must be completed on same working day that samples are eluted)

June 2003


[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Pages 64421-64423]
[FR Doc No: 2014-25675]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73419; File No. 10-214]

Automated Matching Systems Exchange, LLC; Order Instituting
Proceedings To Determine Whether To Grant or Deny an Application for an
Exemption From Registration as a National Securities Exchange Under
Section 5 of the Securities Exchange Act of 1934

October 23, 2014.

I. Introduction

    On July 7, 2014, Automated Matching Systems Exchange, LLC
(``AMSE'') filed with the Securities and Exchange Commission
(``Commission'') an application seeking a limited volume exemption
under Section 5 of the Securities Exchange Act (``Exchange Act'') from
registration as a national securities exchange under Section 6 of the
Exchange Act.\1\ Notice of AMSE's exemption application was published
for comment in the Federal Register on July 29, 2014.\2\ Although
Section 5 of the Exchange Act does not require the Commission to
institute proceedings on whether to grant or deny AMSE's exemption
application, the Commission has determined, in its discretion, to
institute such proceedings in order to solicit further the views of
interested persons on AMSE's exemption application. This order
institutes proceedings to determine whether to grant or deny the
exemption application.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78e.
    \2\ See Securities Exchange Act Release No. 72661 (July 23,
2014), 79 FR 44070 (``Notice). The Commission notes that Section 5
of the Exchange Act did not require publication of AMSE's exemption
application. The Commission determined, in its discretion, to
publish the Notice in order to solicit the views of interested
persons on AMSE's exemption application.
---------------------------------------------------------------------------

II. Description of AMSE's System

    AMSE proposes to conduct business in reliance upon an exemption
from registration as a national securities exchange pursuant to Section
5 of the Exchange Act.\3\ In general, AMSE seeks to operate as an
exchange for alternative trading systems.\4\ AMSE proposes to

operate solely on an ``off-order-book'' trading basis. AMSE does not
intend to have a physical exchange trading floor, centralized order
book, or specialists or market makers with affirmative and negative
market making obligations. Each member of AMSE would maintain its own
automated matching system or electronic order book. Each member of AMSE
would adopt its own rules governing the execution and priority of
orders on its system. Trades would occur when an order to buy and an
order to sell match on a member's electronic order book. Each member
would report its transactions to AMSE at such intervals as required by
AMSE.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78e.
    \4\ For more detail on AMSE's proposed system, see AMSE's full
exemption application and Exhibits, which are published with the
Notice on the Commission's Web site at http://www.sec.gov/rules/other.shtml. The Commission notes that alternative trading systems
are securities markets that meet the definition of exchange under
the Exchange Act. Regulation ATS established an alternative
regulatory regime for securities markets by giving them the choice
to register as exchanges, or to register as broker-dealers and
comply with Regulation ATS. See Securities Exchange Act Release No.
40760 (December 8, 1998), 63 FR 70844, 70847 (December 22, 1998)
(``Regulation ATS Adopting Release''). Rule 300 of Regulation ATS
defines an alternative trading system to mean ``any organization,
association, person, group of persons, or system: (1) That
constitutes, maintains, or provides a market place or facilities for
bringing together purchasers and sellers of securities or for
otherwise performing with respect to securities the functions
commonly performed by a stock exchange within the meaning of [Rule
3b-16]; and (2) That does not: (i) Set rules governing the conduct
of subscribers other than the conduct of such subscribers trading on
such organization, association, person, group of persons, or system;
or (ii) Discipline subscribers other than by exclusion from
trading.'' See 17 CFR 242.300(a).
---------------------------------------------------------------------------

III. Proceedings To Determine Whether To Grant or Deny the Exemption
Application and Grounds for Denial Under Consideration

    The Commission is instituting proceedings to determine whether
AMSE's exemption application should be granted or denied. Institution
of such proceedings is appropriate at this time in view of the legal
and policy issues raised by the exemption application. Institution of
proceedings does not indicate that the Commission has reached any
conclusions with respect to any of the issues involved. Rather, as
described in greater detail below, the Commission seeks and encourages
interested persons to provide additional comment on the exemption
application.
    The Commission is providing notice of the grounds for denial under
consideration. Section 5 of the Exchange Act allows the Commission to
exempt an exchange from the requirements of exchange registration if
``in the opinion of the Commission, by reason of the limited volume of
transactions effected on such exchange, it is not practicable and not
necessary or appropriate in the public interest or for the protection
of investors to require such registration.'' \5\ Section 3(a)(1) of the
Exchange Act \6\ defines an ``exchange'' to be ``any organization,
association, or group of persons, whether incorporated or incorporated,
which constitutes, maintains, or provides a market place or facilities
for bringing together purchasers and sellers of securities or for
otherwise performing with respect to securities the functions commonly
performed by a stock market as that term is generally understood, and
includes the market place and facilities maintained by such exchange.''
Rule 3b-16 under the Exchange Act \7\ further provides that ``[a]n
organization, association, or group of persons shall be considered to
constitute, maintain, or provide `a market place or facilities for
bringing together purchasers and sellers of securities or for otherwise
performing with respect to securities the functions commonly performed
by a stock exchange,' as those terms are used in Section 3(a)(1) of the
Act, (15 U.S.C. 78c(a)(1)), if such organization, association, or group
of persons: (1) Brings together the orders of securities of multiple
buyers and sellers; and (2) Uses established, non-discretionary methods
(whether by providing a trading facility or by setting rules) under
which such orders interact with each other, and the buyers and sellers
entering such orders agree to the terms of the trade.''
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78e.
    \6\ 15 U.S.C. 78c(a)(1).
    \7\ 17 CFR 240.3b-16.
---------------------------------------------------------------------------

    As noted above, trades would occur on the separate systems of the
individual members of AMSE. As described in the AMSE exemption
application, it does not appear that the orders of the individual
members of AMSE would interact with one another on any AMSE system, but
rather on each distinct and separate system of AMSE's members. That is,
it does not appear that any AMSE system would operate as an exchange by
bringing together purchasers and sellers of securities. As a result,
the Commission is concerned that AMSE's exemption application does not
meet a key threshold requirement for being granted an exemption from
exchange registration--namely, that the applicant actually be an
``exchange'' as defined under Section 3(a)(1) of the Exchange Act and
Rule 3b-16 thereunder.\8\
---------------------------------------------------------------------------

    \8\ See Regulation ATS Adopting Release, 63 FR at 70898-70901
(discussing the Commission's revised interpretation of the
``exchange'' definition). Among other things, the Commission stated
that ``the first essential element of an exchange is the bringing
together of orders of multiple buyers and sellers.'' Id. at 70900.
---------------------------------------------------------------------------

    Accordingly, the Commission believes that it is appropriate at this
time to issue this order to institute proceedings to determine whether
to grant or deny the exemption application on the grounds that the
applicant does not meet the definition of an ``exchange'' under Section
3(a)(1) of the Exchange Act and Rule 3b-16 thereunder.

IV. Procedure: Request for Written Comments

    The Commission requests written views, data, and arguments with
respect to the concerns identified above as well as other relevant
concerns. Such comments should be submitted by November 19, 2014.
Rebuttal comments should be submitted by December 3, 2014. Although
there do not appear to be any issues relevant to a grant or denial of
the exemption application which would be facilitated by an oral
presentation of views, data, and arguments, the Commission will
consider any request for an opportunity to make an oral presentation.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/other.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number 10-214 on the subject line.

Paper Comments

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

All submissions should refer to File Number 10-214. 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/other.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the exemptive application that are filed
with the Commission, and all written communications relating to the
exemptive application 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 10:00 a.m. and 3:00 p.m. 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 publicly available. All
submissions should refer to File Number 10-214 and should be submitted
on or before November 19, 2014. Rebuttal comments should be submitted
by December 3, 2014.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-25675 Filed 10-28-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Rules and Regulations]
[Pages 45187-45191]
[FR Doc No: 2017-20724]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2017-0215; FRL-9968-34-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Removal of Clean Air Interstate Rule (CAIR) Trading Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a state implementation plan (SIP) revision
submitted by the Commonwealth of Virginia. The submitted revision
requests EPA remove from the Virginia SIP regulations from the Virginia
Administrative Code that established EPA-administered trading programs
under the Clean Air Interstate Rule (CAIR), one of which also included
requirements to address nitrogen oxide (NOX) reductions
required under the NOX SIP Call. The EPA-administered
trading programs under CAIR were discontinued on December 31, 2014 upon
the implementation of the Cross-State Air Pollution Rule (CSAPR), which
was promulgated by EPA to replace CAIR. CSAPR established federal
implementation plans (FIPs) for 23 states, including Virginia. The SIP
submittal seeks removal from the Virginia SIP of Virginia regulations
that implemented the CAIR annual NOX, ozone season
NOX, and sulfur dioxide (SO2) trading programs
(as CSAPR has replaced CAIR). EPA is approving the SIP revision in
accordance with the requirements of the Clean Air Act (CAA).

DATES: This rule is effective on November 27, 2017 without further
notice, unless EPA receives adverse written comment by October 30,
2017. If EPA receives such comments, it will publish a timely
withdrawal of the direct final rule in the Federal Register and inform
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2017-0215 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be

confidential business information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Sara Calcinore,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 5, 2017, the Commonwealth of
Virginia, through the Virginia Department of Environmental Quality
(VADEQ), submitted a SIP revision (Revision D16) that requests removal
from its SIP of Virginia Administrative Code regulations including 9
VAC 5 Chapter 140: Part II--NOX Annual Trading Program; Part
III--NOX Ozone Season Trading Program; and Part IV--
SO2 Annual Trading Program (Sections 5-140-1010 through 5-
140-3880).

I. Background

    EPA promulgated CAIR (70 FR 25162, May 12, 2005) to address
transported emissions that significantly contributed to downwind
states' nonattainment and maintenance of the 1997 ozone and fine
particulate matter (PM2.5) national ambient air quality
standards (NAAQS). CAIR required 28 states, including Virginia, to
reduce emissions of NOX and SO2, precursors to
the formation of ambient ozone and PM2.5. Under CAIR, EPA
established federal implementation plans (FIPs) comprised of separate
cap and trade programs for annual NOX, ozone season
NOX, and annual SO2. States could comply with the
requirements of CAIR by remaining on the FIP, which applied only to
electric generating units (EGUs), or by submitting a CAIR SIP revision
that included as trading sources EGUs and certain non-EGUs \1\ that
formerly traded in the NOX Budget Trading Program under the
NOX SIP Call.\2\ On December 28, 2007 (72 FR 73602), EPA
approved a SIP revision submitted by Virginia that allowed the
Commonwealth to participate in the EPA-administered CAIR regional cap
and trade programs for NOX annual, NOX ozone
season, and SO2 annual emissions. Virginia's NOX
ozone season trading program under CAIR included non-EGUs that were
previously trading in the NOX budget trading program under
the NOX SIP Call, which satisfied Virginia's obligations
under the NOX SIP Call.
---------------------------------------------------------------------------

    \1\ These non-EGUs are defined in the NOX SIP Call as
stationary, fossil fuel-fired boilers, combustion turbines, or
combined cycle systems with a maximum design heat input greater than
250 million British thermal units per hour (MMBtu/hr).
    \2\ In October 1998, EPA finalized the ``Finding of Significant
Contribution and Rulemaking for Certain States in the Ozone
Transport Assessment Group Region for Purposes of Reducing Regional
Transport of Ozone''--commonly called the NOX SIP Call.
See 63 FR 57356 (October 27, 1998).
---------------------------------------------------------------------------

    After EPA promulgated CAIR, litigation ensued. The United States
Court of Appeals for the District of Columbia Circuit (D.C. Circuit)
initially vacated CAIR in 2008,\3\ but ultimately remanded the rule to
EPA without vacatur to preserve the environmental benefits provided by
CAIR.\4\ The ruling allowed CAIR to remain in effect temporarily until
a replacement rule consistent with the D.C. Circuit's opinion was
developed. While EPA worked on developing a replacement rule, the CAIR
program continued as planned with the NOX annual and ozone
season programs beginning in 2009 and the SO2 annual program
beginning in 2010.
---------------------------------------------------------------------------

    \3\ North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008).
    \4\ North Carolina v. EPA, 550 F.3d 1176 (D.C. Cir. 2008).
---------------------------------------------------------------------------

    On August 8, 2011 (76 FR 48208), acting on the D.C. Circuit's
remand, EPA promulgated CSAPR to replace CAIR to address the interstate
transport of emissions contributing to nonattainment and interfering
with maintenance of the two air quality standards covered by CAIR as
well as the 2006 PM2.5 NAAQS. The rule also contained
provisions that would sunset CAIR-related obligations on a schedule
coordinated with the implementation of CSAPR compliance requirements.
CSAPR was to become effective January 1, 2012; however, the timing of
CSAPR's implementation was impacted by a number of court actions.
    Numerous parties filed petitions for review of CSAPR in the D.C.
Circuit, and on December 30, 2011, the D.C. Circuit stayed CSAPR prior
to its implementation and ordered EPA to continue administering CAIR on
an interim basis.\5\ On August 21, 2012, the D.C. Circuit issued its
ruling, vacating and remanding CSAPR to EPA and ordering continued
implementation of CAIR. EME Homer City Generation, L.P. v. EPA, 696
F.3d 7, 38 (D.C. Cir. 2012). The D.C. Circuit's vacatur of CSAPR was
reversed by the United States Supreme Court on April 29, 2014, and the
case was remanded to the D.C. Circuit to resolve remaining issues in
accordance with the Supreme Court's ruling. EPA v. EME Homer City
Generation, L.P., 134 S. Ct. 1584 (2014). On remand, the D.C. Circuit
affirmed CSAPR in most respects.
---------------------------------------------------------------------------

    \5\ Order of Dec. 30, 2011, in EME Homer City Generation, L.P.
v. EPA, D.C. Cir. No. 11-1302.
---------------------------------------------------------------------------

    Throughout the initial round of D.C. Circuit proceedings and the
ensuing Supreme Court proceedings, the stay on CSAPR remained in place,
and EPA continued to implement CAIR. Following the April 2014 Supreme
Court decision, EPA filed a motion asking the D.C. Circuit to lift the
stay in order to allow CSAPR to replace CAIR in an equitable and
orderly manner while further D.C. Circuit proceedings were held to
resolve remaining claims from petitioners. Additionally, EPA's motion
requested to toll, by three years, all CSAPR compliance deadlines that
had not passed as of the approval date of the stay. On October 23,
2014, the D.C. Circuit granted EPA's request,\6\ and on December 3,
2014 (79 FR 71663), in an interim final rule, EPA set the updated
effective date of CSAPR as January 1, 2015 and tolled the
implementation of CSAPR Phase I to 2015 and CSAPR Phase 2 to 2017. In
accordance with the interim final rule, the sunset date for CAIR was
December 31, 2014, and EPA began implementing CSAPR on January 1, 2015.
---------------------------------------------------------------------------

    \6\ Order Document #1518738, EME Homer City Generation, L.P. v.
EPA, No. 11-1302 (D.C. Cir. Issued Oct. 23, 2014).
---------------------------------------------------------------------------

    Starting in January 2015, the CSAPR FIP trading programs for annual
NOX, ozone season NOX, and annual SO2
were applicable in Virginia. Thus, since January 1, 2015, Virginia
regulations implementing the CAIR annual trading programs, including
the NOX ozone season trading program addressing Virginia's
obligations under the NOX SIP Call, have been obsolete and
moot and none of these programs contribute to emission reductions in
Virginia.
    On October 26, 2016 (81 FR 74504), EPA finalized the CSAPR Update
Rule to address interstate transport of ozone pollution with respect to
the 2008 ozone NAAQS, and issued FIPs that updated the ozone season
NOX budgets for 22 states, including Virginia. Starting in
January 2017, the CSAPR Update budgets were implemented via
modifications to the CSAPR NOX ozone season allowance
trading program that was established under the original CSAPR.

II. Summary of SIP Revision and EPA Analysis

    VADEQ submitted a SIP revision on January 5, 2017 requesting the
removal of regulations from the Virginia SIP under 9 VAC 5 Chapter 140:
Part II--NOX Annual Trading Program, Part III--
NOX Ozone Season Trading Program, and Part IV--
SO2 Annual Trading Program (Sections 5-140-1010 through 5-
140-3880), which implemented the CAIR annual NOX, ozone
season NOX, and annual SO2 trading programs.
These regulations have been moot since January 1, 2015, when CSAPR
replaced CAIR, and have been repealed in their entirety from the
Virginia Administrative Code. The amendments removing these regulations
were adopted by the State Air Pollution Control Board on September 9,
2016 and were effective as of November 16, 2016.
    As noted previously, on January 1, 2015, the CAIR annual
NOX, ozone season NOX, and annual SO2
trading programs were replaced by the trading programs under the CSAPR
FIP. Therefore, regulations in the Virginia SIP that implemented the
CAIR annual trading programs have been obsolete and moot since January
1, 2015. None of the provisions in 9 VAC 5 Chapter 140 which Virginia
seeks to remove from the SIP presently reduce NOX or
SO2 emissions from EGUs or certain non-EGUs after December
31, 2014 as CAIR was replaced by CSAPR.
    These obsolete regulations include provisions under 9 VAC 5 Chapter
140: Part III--NOX Ozone Season Trading Program Article 1--
CAIR NOX Ozone Season Trading Program General Provisions and
Article 5--CAIR NOX Ozone Season Allowance Allocations,
which addressed Virginia's obligations under the NOX SIP
Call by including EGUs and certain large non-EGUs that had formerly
traded under the NOX SIP Call trading program as CAIR
trading sources. Unlike the CAIR trading program, CSAPR's trading
program for ozone season NOX as promulgated in 2011 does not
provide for non-EGUs to participate in trading. Therefore, since
January 1, 2015, when CSAPR replaced CAIR and the CSAPR FIP became
effective in Virginia, the Virginia SIP has not contained an effective
regulation addressing Virginia's obligation under the NOX
SIP Call to reduce NOX emissions from non-EGUs such as
stationary, fossil fuel-fired boilers, combustion turbines, or combined
cycle systems with a maximum design heat input greater than 250 MMBtu/
hr. The absence of an effective regulation in the Virginia SIP to
reduce NOX emissions from these non-EGUs that formerly
participated in the CAIR trading program resulted from the sunset of
CAIR and EPA's implementation of CSAPR starting January 1, 2015.
Because CSAPR did not provide for trading by non-EGUs, Virginia's SIP
no longer meets the Virginia NOX SIP Call obligation with
respect to these non-EGUs that formerly traded in CAIR. However,
Virginia's request in its January 5, 2017 SIP seeking removal from its
SIP of 9 VAC 5 Chapter 140: Part III--NOX Ozone Season
Trading Program and EPA's action to approve the January 5, 2017
submittal did not create this gap in coverage under the Virginia SIP.
According to Virginia, the Commonwealth is in the process of drafting a
regulation to address the Commonwealth's obligations under the
NOX SIP Call (including its obligation to address these non-
EGUs which formerly traded in CAIR). In remedying its provisions to
address the NOX SIP Call, Virginia must satisfy the
requirements of 40 CFR 51.121(f) which lists requirements such as
control measures to be included in SIP revisions to meet NOX
budgets assigned under the NOX SIP Call. EPA expects
Virginia will submit such provisions to EPA to be included in
Virginia's SIP, and EPA will review and act on any such SIP submittal
from Virginia addressing the Commonwealth's NOX SIP Call
obligations in a separate rulemaking.
    Since the regulations implementing the CAIR annual NOX,
ozone season NOX, and annual SO2 trading programs
have been moot and non-operational since CAIR was replaced by CSAPR on
January 1, 2015, removing these regulations from the Virginia SIP will
not interfere with reduction of NOX or SO2
emissions in Virginia and will not interfere with Virginia's attainment
of any NAAQS, reasonable further progress, or any other applicable CAA
requirement. In addition, as Virginia's SIP has not effectively
addressed non-EGUs that formerly traded in CAIR for NOX SIP
Call obligations since CAIR sunset, removing 9 VAC 5 Chapter 140: Part
III--NOX Ozone Season Trading Program from the Virginia SIP
will also not interfere with attainment of NAAQS, reasonable further
progress, or any CAA requirement as the CAIR's sunset removed the non-
EGUs from the ozone season NOX trading program. Thus, EPA
finds the January 5, 2017 SIP revision approvable in accordance with
section 110 of the CAA, including specifically with section 110(l) of
the CAA.

III. Final Action

    EPA is approving the January 5, 2017 SIP revision submission from
the Commonwealth of Virginia, which sought removal from the Virginia
SIP of moot regulations under 9 VAC 5 Chapter 140 that implemented the
CAIR annual NOX, ozone season NOX, and annual
SO2 trading programs at Part II--NOX Annual
Trading Program; Part III--NOX Ozone Season Trading Program;
and Part IV--SO2 Annual Trading Program (Sections 5-140-1010
through 5-140-3880). EPA is publishing this rule without prior proposal
because EPA views this as a noncontroversial amendment and anticipates
no adverse comment. However, in the ``Proposed Rules'' section of
today's Federal Register, EPA is publishing a separate document that
will serve as the proposal to approve the SIP revision if adverse
comments are filed. This rule will be effective on November 27, 2017
without further notice unless EPA receives adverse comment by October
30, 2017. If EPA receives adverse comment, EPA will publish a timely
withdrawal in the Federal Register informing the public that the rule
will not take effect. EPA will address all public comments in a
subsequent final rule based on the proposed rule. EPA will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. Please note that if
EPA receives adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, EPA may adopt as final those provisions of the rule that are
not the subject of an adverse comment.

IV. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the

content of those documents that are the product of a voluntary
environmental assessment. The Privilege Law does not extend to
documents or information that: (1) Are generated or developed before
the commencement of a voluntary environmental assessment; (2) are
prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege Law, Va. Code Sec.  10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
federally authorized environmental programs in a manner that is no less
stringent than their federal counterparts . . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by federal law to maintain program delegation, authorization or
approval.'' Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides
that ``[t]o the extent consistent with requirements imposed by federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land as
defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 27, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking action.
    This action removing from the Virginia SIP regulations under
Sections 5-140-1010 through 5-140-3880 of 9 VAC 5 Chapter 140 that
implemented the CAIR annual NOX, ozone season
NOX, and annual SO2 trading programs 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, Sulfur
oxides, Volatile organic compounds.

    Dated: September 8, 2017.
Cecil Rodrigues,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended 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 VV--Virginia

Sec.  52.2420  [Amended]

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by:
0
a. Removing the section entitled ``Part II NOX Annual
Trading Program'', including ``Article 1'' through ``Article 9''
including entries ``5-140-1010'' through ``5-140-1880'';
0
b. Removing the section entitled ``Part III NOX Ozone Season
Trading Program'', including ``Article 1'' through ``Article 9''
including entries ``5-140-2010'' through ``5-140-2880''; and;
0
c. Removing the section entitled ``Part IV SO2 Annual
Trading Program'', including ``Article 1'' through ``Article 9''
including entries ``5-140-3010'' through ``5-140-3880''.

[FR Doc. 2017-20724 Filed 9-27-17; 8:45 am]
BILLING CODE 6560-50-P


  MacroButton macIb01 i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [insert name and telephone number
with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[Dow AgroSciences, LLC]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
[Dow AgroSciences, LLC], [9330 Zionsville Rd., Indianapolis, IN 46268]
requesting, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

by establishing a tolerance for residues of

	[methoxyfenozide, including its metabolites and degradates.  Compliance
with the tolerance levels is to be determined by measuring only the
active ingredient: methoxyfenozide [3-methoxy-2-methylbenzoic acid
2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide]] in or on the
raw agricultural commodity [under paragraph (a)  as Pineapple] at [0.7]
parts per million (ppm).  EPA has determined that the petition contains
data or information regarding the elements set forth in section 408
(d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data supports granting
of the petition. Additional data may be needed before EPA rules on the
petition.

A. Residue Chemistry

	1. Plant metabolism. [Per the EPA analytical summary for
methoxyfenozide (D. Rate, US EPA, DP358341, June 10, 2009), the nature
of the residue of methoxyfenozide in plants has been studied in several
plants (apple, cotton, grape and rice) and is adequately understood.

	2. Analytical method. [Per a recent 2012 decision on tolerances (M.
Collantes, US EPA, D388978, May 23, 2012), EPA stated adequate single
methods are available for tolerance enforcement in primary crops and
animal commodities.  Analytical methodology for the magnitude of residue
studies was based on Dow AgroSciences method GRM 02.25 “Determination
of Residues of Methoxyfenozide in High Moisture Crops by Liquid
Chromatography with Tandem Mass Spectrometry Detection“.]

	3. Magnitude of residues. [The proposed tolerance in pineapple is
supported by magnitude of residue studies in pineapple. Thus, the
requested tolerance is adequately supported.

Dow AgroSciences recently completed trials in pineapples with 3 and 10
day PHIs (Dow AgroSciences Study No. 110317, March 14, 2012).  Residues
of methoxyfenozide were determined following 4 foliar applications of
GF-837 at 4 field locations in Costa Rica and 4 field locations in
Hawaii during the 2011 growing season.  Methoxyfenozide was applied at a
target rate of 0.107 lb ai/A, for a total of approximately 0.428 lb
ai/A.  A surfactant was included in each tank mix.  Marketable mature
fruit was collected 3 and 10 days after the final application.  For the
3-day PHI, methoxyfenozide observed residues in pineapple ranged from
0.0808-0.365 ppm with a HAFT of 0.346 in the Hawaii trials and
0.0276-0.0824 ppm with a HAFT of 0.0626 in the Costa Rica trials.  For
the 10-day PHI, methoxyfenozide observed residues in pineapple ranged
from 0.109-0.374 ppm with a HAFT of 0.355 ppm in the Hawaii trials and
0.0189-0.0277 ppm with a HAFT of 0.0266 ppm in the Costa Rica trials.
The LOD and LOQ values were calculated as 0.003 ppm and 0.001 ppm,
respectively for pineapple.]

B. Toxicological Profile [The toxicological profile for methoxyfenozide
which supports this petition to revise tolerances was reviewed in 2009
(Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009) and again in
the the 2012 Human Health review (Collantes, US EPA, D388978, May 23,
2012), and the endpoints for risk assessment are reiterated in EPA’s
most recent dietary assessment (EPA, Holman, D389738, March 2, 2012).
EPA has concluded “The toxicity database is considered complete for
the purposes of characterizing the hazard associated with
methoxyfenozide and for conducting a human health risk assessment.”
EPA has not established an acute reference dose for methoxyfenozide and
the chronic RfD is equivalent to the chronic PAD = 0.1 mg/kg/day,
because the FQPA SF has been reduced to 1X.]

	1. Acute toxicity.  [Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009) , no significant
acute hazards were attributable to a single exposure in the available
toxicology studies on methoxyfenozide including the acute neurotoxicity
study in rats, the developmental toxicity studying rats and the
developmental toxicity study in rabbits.  Since no acute toxicological
endpoints were established, no acute assessment is required.]

	2. Genotoxicty. [Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), methoxyfenozide
demonstrated a “lack of genotoxicity in an acceptable battery of
mutagenicity studies.”]

	3. Reproductive and developmental toxicity. [Per the 2009 Human Health
review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009),
methoxyfenozide “is not a developmental or reproductive toxicant”.
The toxicology data base available for methoxyfenozide included
acceptable developmental toxicity studies in both rats and rabbits as
well as a 2-generation reproductive toxicity study in rats.  The data
provided no indication of increased sensitivity of rats or rabbits to in
utero and/or postnatal exposure to methoxyfenozide.  EPA determined that
an additional safety factor was not needed for the protection of infants
and children (FQPA SF = 1x).]

	4. Subchronic toxicity. [Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in subchronic and
chronic oral studies in rats, the most toxicologically significant
effects were mild anemia and mild effects on the liver, thyroid gland,
and adrenal gland. In subchronic and chronic oral studies in dogs, the
predominant toxic effect was anemia, which was often accompanied by
signs of a compensatory response.  In 2012 (Colantes, US EPA, D388978,
May 2012), new inhalation endpoints for Short-Term (1-30 days) and
Intermediate Term (1-6 months) were established with a NOAEL of 16.8
mg/kg/day for use in residential and occupational assessments.]

	5. Chronic toxicity. [Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), the chronic
population-adjusted dose (cPAD) is 0.1 mg/kg/day based on hematological
changes, liver toxicity, histopathological changes in thyroid and
possible adrenal toxicity observed at the LOAEL of 411 mg/kg/day in a
chronic toxicity study in rats.]

	6. Animal metabolism. [Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in a metabolism
study in rats, 14C-methoxyfenozide was rapidly absorbed, distributed,
metabolized and almost completely excreted within 48 hours. The major
route of excretion was feces (86-97%) with lesser amounts in the urine
(5-13%).  Metabolism of methoxyfenozide in other animals (poultry and
ruminants) appears to be similar to its metabolism in rats.  Per the EPA
analytical summary for methoxyfenozide (D. Rate, US EPA, DP358341, June
10, 2009), the qualitative nature of methoxyfenozide residues in
livestock are adequately understood based on ruminant and poultry
metabolism studies.  The residue of concern is parent in milk and
ruminant tissues (except meat byproducts), poultry meat and fat.  The
residues of concern in meat byproducts and eggs are methoxyfenozide and
the RH-141,518 metabolite.]

	7. Metabolite toxicology. [Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in a metabolism
study in rats, methoxyfenozide is metabolized principally by
O-demethylation of the A-ring methoxy group and oxidative hydroxylation
of the B-ring methyl groups followed by conjugation with glucuronic
acid. No significant sex-related or dose-dependent differences in
metabolic disposition were noted. The methoxyfenozide glucuronide
conjugates are considered to be less toxic than the parent compound
because glucuronide conjugation is well known to be a commonly occurring
detoxification mechanism in mammalian species since it results in the
formation of more polar, more water-soluble metabolites which are
readily and easily excreted from the body (in this case, in the bile and
urine). Further, based on similarities of chemical structure, the
non-conjugated metabolites would be expected to be no more toxic than
the parent compound. Furthermore, HED has covered potential metabolite
exposure by inclusion of RH-141,518 along with the parent
methoxyfenozide in the residue of concern for certain commodities:
ruminant liver and kidney, eggs, poultry liver and poultry meat
byproducts.]

	8. Endocrine disruption. [The available mammalian toxicity and
toxicokinetic studies on methoxyfenozide, including a 2-generation
reproduction study, developmental toxicity studies in two species, and
repeat dose toxicity studies ranging from 28 days to 2 year studies in
three species (rat, mouse, and dog), do not demonstrate that
methoxyfenozide possesses endocrine disrupting properties that are
relevant to humans.]

C. Aggregate Exposure

	1. Dietary exposure. [The starting point for this assessment was the
DEEM file from the 2012 EPA dietary assessment (EPA, Holman, D389738,
March 2, 2012).  The Dietary Exposure Evaluation Model™ (DEEM-FCID,
ver. 3.14) software was employed.  DEEM contains food consumption data
based on NHANES 2-day food Consumption data for 2003 to 2008 and food
translation to RACs, as indicated by EPA/USDA FCID recipe set as of
February 2012.]

	i. Food. [A chronic assessment was conducted to evaluate potential
chronic dietary exposure of the U.S. population subgroups to residues of
methoxyfenozide.  These analyses cover all registered crops, as well the
proposed tolerance.  The current dietary assessment is an unrefined Tier
I assessment using tolerance values and 100% crop-treated assumption to
estimate dietary exposure to methoxyfenozide and default processing
factors for all food commodities, with the exception of a
methoxyfenozide-specific processing factor for orange juice (0.2X).]

	ii. Drinking water. [There are no water-related exposure data from
monitoring to complete a quantitative drinking water exposure analysis
and risk assessment for methoxyfenozide.  The previous EPA estimates of
33.1 ppb were conservatively increased by EFED based on new model
assumptions in 2012 (Gebken, US EPA, D388876, May 23, 2012).  For
potential drinking water exposures, the new value of 43.4 ppb has been
directly incorporated in the DEEM-FCID into the food categories
“water, direct, all sources” and “water, indirect, all sources.”

Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004,
D357983, July 22, 2009), the established chronic endpoints are cRfD =
cPAD = 0.10 mg/kg/day.  The Tier-I DEEM exposure for food and water with
revised proposed tolerances resulted in an estimated exposure of
0.023719 mg/kg/day for the US general population which is 23.7% of the
chronic RfD.  For the most highly exposed population subgroup, children
1 to 2 years old, the estimated exposure is 0.063427 mg/kg/day at 63.4%
of cPAD.  These results are conservative (health protective) risk
estimates.  Refinements such as use of percent crop-treated information
and/or anticipated residue values would yield lower estimates of chronic
dietary exposure.]

	2. Non-dietary exposure. [A new use in ornamentals was approved for
methoxyfenozide in 2009.  Per the 2012 review (Collantes, US EPA,
D388978, May 23, 2012), EPA made the conservative interpretation that
the label did not preclude homeowner use on ornamentals. Thus in
accordance with FQPA, EPA conducted an aggregate assessment to include
residential handler exposure for adults.  The dietary exposure of the
general adult US population was aggregated with exposure estimates from
residential use of a backpack sprayer treatment of ornamentals.  The
calculated exposure resulted in an aggregate MOE of 670, which is
significantly higher than the stated LOC of 100 for methoxyfenozide, and
thus is not of concern.  The current assessment resulted in slightly
lower estimates of adult dietary exposure (due to changes in the
DEEM-FCID dietary intake model).  Thus the small change in the dietary
contribution resulted in a slight increase in the MOE for adults from
670 to 700; the risk estimate is not of concern for adults.  It is also
noted that for children, the EPA concluded that: “there are no
residential uses of methoxyfenozide that would result in significant
postapplication exposure to children, based on ornamental use only.
Therefore the aggregate exposure and risk for children is equivalent to
those from food and water.”]

D. Cumulative Effects

	[Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency considers
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”  EPA does not have, at this time,
available data to determine whether methoxyfenozide has a common
mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment.  Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, methoxyfenozide does not appear to produce a
toxic metabolite produced by other substances.  For the purposes of this
tolerance action, therefore, it is assumed that methoxyfenozide does not
have a common mechanism of toxicity with other substances.]

E. Safety Determination

	1. U.S. population. [Using the DEEM 3.14 exposure assumptions described
above, the dietary and water exposure to methoxyfenozide from the
current and proposed new tolerances will utilize 23.7% of the chronic
RfD for the US population.  EPA generally has no concern for exposures
below 100% of the chronic RfD. It is concluded that there is a
reasonable certainty that no harm will result to US-general population
from dietary exposure to methoxyfenozide residues. When the food, water
and residential exposures are aggregated for adults, the resulting MOEs
are 700, which are well above the LOC of 100; values above the LOC are
typically not of a concern for the Agency.]

	2. Infants and children. [Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 20090, EPA has previously
determined that an additional safety factor was not needed for the
protection of infants and children (FQPA SF = 1x).  Using the DEEM
exposure assumptions described above for the dietary and water exposure
to methoxyfenozide with the current and proposed new tolerances, the
highest exposed subpopulation is children 1-2 years at 63.4% of the
cPAD.  EPA generally has no concern for exposures below 100% of the cPAD
because the cPAD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health.  The residential uses are not anticipated to result in
exposure to children, so the aggregate exposure is equivalent to the
dietary exposure, and therefore is not of concern.]

F. International Tolerances

	[Several governing bodies have established Maximum Residue Levels
(MRLs) for methoxyfenozide in a variety of crops.  The related
international MRLs are found in the following table based on a review of
MRLs compiled by searches in the USDA MRL database ( HYPERLINK
"http://www.mrldatabase.com/results.cfm"
http://www.mrldatabase.com/results.cfm ), Homologa ( HYPERLINK
"http://www.homologa.com/" http://www.homologa.com/ ), the EU SANCO
website ( HYPERLINK
"http://ec.europa.eu/sanco_pesticides/public/index.cfm"
http://ec.europa.eu/sanco_pesticides/public/index.cfm ), Japan MRL
listing ( HYPERLINK
"http://www.m5.ws001.squarestart.ne.jp/foundation/agrdtl.php?a_inq=75700
"
http://www.m5.ws001.squarestart.ne.jp/foundation/agrdtl.php?a_inq=75700
) and the Australian MRL website ( HYPERLINK
"http://www.comlaw.gov.au/Series/F2008B00619"
http://www.comlaw.gov.au/Series/F2008B00619 ) .  Homologa is a third
party database; Dow AgroSciences makes no claim regarding the
verification of these values relative to the individual national
authoritative sources.  Listed tolerance on pineapples, seem to have
been driven by positive lists which are set at the method LOQ level.

Commodity	Existing MRLa

(ppm)	Regulatory Authority

Pineapple	0.02	EU SANCO

Other Fruits	0.1	Japan

Pineapple	0.02	Chile

]

 PAGE

 PAGE   6


[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31630-31631]
[FR Doc No: 2016-11766]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0643; FRL-9946-04-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Pressure Sensitive Tape and Label
Surface Coating Operations (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NSPS for Pressure Sensitive
Tape and Label Surface Coating Operations (40 CFR part 60, subpart RR)
(Renewal)'' (EPA ICR No. 0658.12, OMB Control No. 2060-0004), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
This is a proposed extension of the ICR, which is currently approved
through May 31, 2016. Public comments were previously requested via the
Federal Register (80 FR 32116) on June 5, 2015 during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before June 20, 2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0643, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  Supporting documents which explain in
detail the information that the EPA will be collecting are available in
the public docket for this ICR. The docket can be viewed either online
at www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW.,

Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit:
http://www.epa.gov/dockets.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A, and any changes,
or additions to the Provisions specified at 40 CFR part 60, subpart RR.
Owners or operators of the affected facilities must submit initial
notification, performance tests, and periodic reports and results.
Owners or operators are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. Reports, at a minimum, are required
semiannually.
    Form Numbers: None.
    Respondents/affected entities: Pressure sensitive tape and label
surface coating facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart RR).
    Estimated number of respondents: 42 (total).
    Frequency of response: Initially, quarterly and semiannually.
    Total estimated burden: 3,970 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $482,000 (per year), includes $82,600 in both
annualized capital/startup and operation & maintenance costs.
    Changes in the Estimates: There is an adjustment increase in burden
from the previous ICR, including increases in the respondent labor
hours, O&M cost, and number of responses. This is due to an increase in
the estimated number of sources subject to the standard. In this ICR,
we assume the industry continues to grow at a rate of one new source
per year. Additionally, there is a small change in the assumption where
we assume all existing sources will need to re-familiarize with the
regulatory requirements each year. This change in assumption also
contributes to the increase in respondent labor hours.

Courtney Kerwin,
Acting-Director, Collection Strategies Division.
[FR Doc. 2016-11766 Filed 5-18-16; 8:45 am]
 BILLING CODE 6560-50-P