[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Proposed Rules]
[Pages 2846-2850]
[FR Doc No: 2015-00866]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2013-0804; FRL-9921-84-Region 6]

Approval and Promulgation of Implementation Plans; Texas;
Reasonably Available Control Technology for the 1997 8-Hour Ozone
National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Texas State Implementation Plan (SIP) for the
Houston/Galveston/Brazoria (HGB), and Dallas Fort Worth (DFW) 1997 8-
Hour ozone nonattainment areas. The HGB area consists of Brazoria,
Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery and Waller
counties. The DFW area consists of Collin, Dallas, Denton, Ellis,
Johnson, Kaufman, Parker, Rockwall, and Tarrant counties. Specifically,
we are proposing to approve portions of multiple revisions to the Texas
SIP submitted by the Texas Commission on Environmental Quality (TCEQ)
as meeting Reasonably Available Control Technology (RACT) requirements.
The RACT requirements apply to sources of Volatile Organic Compounds
(VOC) and Oxides of Nitrogen (NOX) in these areas. This
action is in accordance with the federal Clean Air Act (the Act, CAA).

DATES: Comments must be received on or before February 20, 2015.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2013-0804, by one of the following methods:
     www.regulations.gov. Follow the on-line instructions for
submitting comments.
     Email: Alan Shar at<EMAIL_ADDRESS>     Mail or delivery: Air Planning Section Chief (6PD-L),
Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas,
Texas 75202-2733.
    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-
2013-0804. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit information
through www.regulations.gov or email that you consider to be CBI or
otherwise protected from disclosure. The www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters and any form of encryption, and be free
of any defects or viruses. For additional information about EPA's
public docket, visit the EPA

Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available at either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment with the person listed in the FOR FURTHER INFORMATION
CONTACT paragraph below.

FOR FURTHER INFORMATION CONTACT: Mr. Alan Shar (6PD-L), telephone (214)
665-6691, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA.

Outline

I. Background
    A. What actions are we proposing?
    B. What is RACT?
II. Evaluation
    A. What is TCEQ's approach and analysis to RACT?
    B. What Control Techniques Guidelines (CTG) source categories
are we addressing in this action?
    C. Are there negative declarations for sources of emissions
within these nonattainment areas?
    D. Is Texas' approach to RACT determination for VOC sources
based on their submittals acceptable?
    E. Is Texas' approach to RACT determination for NOX
sources based on their submittals acceptable?
III. Proposed Action
IV. Statutory and Executive Order Reviews

I. Background

A. What actions are we proposing?

    We are proposing to approve multiple revisions, in whole or in
part, to the Texas SIP submitted to EPA as follows: The RACT-related
rule revisions dated December 6, 2013, January 17, 2012, and June 13,
2007, as well as the RACT analysis portions of attainment demonstration
plans of January 17, 2012, April 6, 2010, and June 13, 2007 for the DFW
and HGB areas.
    The December 6, 2013 submittal concerns rule revisions to 30 TAC,
Chapter 115 Control of Air Pollution from Volatile Organic Compounds
for solvent using processes and surface coating application systems. We
are proposing to approve all of this submittal.
    The January 17, 2012 submittal concerns rule revisions to 30 TAC,
Chapter 115 Control of Air Pollution from Volatile Organic Compounds
intended to implement RACT for both HGB and DFW areas. The submittal
will limit VOC content of coatings and solvents used in Flexible
Package Printing, Industrial Cleaning Solvents, Large Appliance
Coatings, Metal Furniture Coatings, Paper, Film, and Foil Coatings,
Miscellaneous Industrial Adhesives, Automobile and Light-Duty Truck
Assembly Coatings, and Miscellaneous Metal and Plastic Parts Coatings
operations. We are proposing to approve all of this submittal.
    Another submittal also dated January 17, 2012 contains a
corresponding analysis to demonstrate RACT is in place for multiple
source categories in the HGB area. We are proposing to approve that
RACT is in place for the source categories listed in the paragraph
above, and we are proposing to approve the Flexographic and Rotogravure
Printing sector for the HGB area of the RACT-related rule revisions
which had not been previously approved.
    A third SIP submittal dated January 17, 2012 contains RACT analysis
for the DFW area. As a result of this submittal, and consistent with
section 182(c) of the Act, the VOC or NOX major source
threshold in the DFW area is lowered to 50 Tons Per Year (TPY) from 100
TPY for RACT purposes under the 1997 8-Hour ozone standard. See EPA-
R06-OAR-2012-0098 (TCEQ Rule Project No. 2010-022-SIP-NR) at
www.regulations.gov. We are proposing to approve the RACT analysis
portion of this submittal.
    The April 6, 2010 attainment demonstration submittal, among other
things, concerns revisions to 30 TAC, Chapter 115 Control of Air
Pollution from Volatile Organic Compounds for control of ozone
pollution in the HGB area. Appendix D of this attainment demonstration
plan is titled ``Reasonably Available Control Technology Analysis,''
and includes source categories affected by the newly EPA-issued Control
Techniques Guidelines (CTGs), and NOX emissions sources. We
are proposing to approve the RACT analysis portion of this submittal.
    The June 13, 2007 attainment demonstration submittal concerns
revisions to 30 TAC, Chapter 115 Control of Air Pollution from Volatile
Organic Compounds. The June 13, 2007 submittal included an analysis
intended to demonstrate RACT was being implemented in the HGB area as
required by the CAA (Appendix B of the submittal). We are proposing to
approve the RACT analysis portion of this submittal.
    We are proposing to approve the above-mentioned revisions, as well
as confirm the RACT finding for revisions previously approved for
Texas, into the Texas SIP.
    In consideration of the above proposed actions and RACT rule
revisions previously approved for Texas, taken together, we are
proposing to approve Texas' RACT analysis as meeting the RACT
requirements for all affected VOC and NOX sources for the
DFW and HGB areas for the 1997 8-Hour ozone standard.

B. What is RACT?

    The EPA has defined RACT as the lowest emissions limitation that a
particular source is capable of meeting by the application of control
technology that is reasonably available, considering technological and
economic feasibility. See September 17, 1979 (44 FR 53761). Section
172(c)(1) of the Act requires that SIPs for nonattainment areas
``provide for the implementation of all reasonably available control
measures as expeditiously as practicable (including such reductions in
emissions from existing sources in the area as may be obtained through
the adoption, at a minimum, of reasonably available control technology)
and shall provide for attainment of the primary National Ambient Air
Quality (NAAQS) standards.''
    Section 182(b)(2) of the Act requires states to submit a SIP
revision and implement RACT for moderate and above ozone nonattainment
areas. For a Moderate, Serious, or Severe area a major stationary
source is one which emits, or has the potential to emit, 100, 50, or 25
tons per year (tpy) or more of VOCs or NOX, respectively.
See CAA sections 182(b), 182(c), and 182(d). The EPA provides states
with guidance concerning what types of controls could constitute RACT
for a given source category through the issuance of CTG and Alternative
Control Techniques (ACT) documents. See http://www.epa.gov/airquality/ozonepollution/SIPToolkit/ctgs.html (URL dating May 13, 2014) for a
listing of EPA-issued CTGs and ACTs.
    The HGB area was designated as Severe for the 1997 8-Hour ozone
NAAQS. See October 1, 2008 (73 FR 56983). Thus, per section 182(d) of
the CAA, a major stationary source in the HGB area is one which emits,
or has the potential to emit, 25 tpy or more of VOCs or NOX.
Under section 182(b), the SIP for the HGB area must implement RACT for
source categories covered by CTGs, and for major sources with a
potential to emit of 25 tpy or more not covered by a CTG. See the two
January 17, 2012 submittals, and the December 6, 2013 submittal.

    Effective June 15, 2004, Collin, Dallas, Denton, Tarrant, Ellis,
Johnson, Kaufman, Parker, and Rockwall counties were designated
nonattainment for the 1997 8-Hour ozone standard. The area was
classified as Moderate nonattainment for the standard, with an
attainment deadline of June 15, 2010. See January 14, 2009 (74 FR
1903). The area was reclassified to Serious on December 20, 2010 (75 FR
79302) because it failed to attain the standard by its attainment
deadline of June 15, 2010. Thus, per section 182(c) of the CAA, a major
stationary source in the DFW area is one which emits, or has the
potential to emit, 50 tpy or more of VOCs or NOX.
    Under section 183(b), EPA is required to periodically review and,
as necessary, update CTGs. The EPA issued a number of new CTGs in 2006,
2007, and 2008. See section II(B) of this document. Accordingly, Texas
revised its Chapter 115 regulations to address these VOC RACT control
measures. See the December 6, 2013, and January 17, 2012 submittals.
Also, see Appendix A of the Technical Support Document (TSD) prepared
in conjunction with this rulemaking action for more information.

II. Evaluation

A. What is TCEQ's approach and analysis to RACT?

    Texas revised its rules because under sections 182(b)(2)(A) and (B)
states must insure RACT is in place for each source category for which
EPA issued a CTG, and for any major source not covered by a CTG. As a
part of its January 17, 2012 submittals TCEQ conducted RACT analyses to
demonstrate that the RACT requirements for CTG sources in the HGB and
DFW 1997 8-Hour ozone nonattainment areas have been fulfilled; the TCEQ
revised and supplemented these analyses for the HGB and DFW areas in
its December 6, 2013 submittal. The TCEQ conducted its RACT analysis
for VOC and NOX by: 1) Identifying all categories of CTG and
major non-CTG sources of VOC emissions within the HGB and DFW areas; 2)
Listing the state regulation that implements or exceeds RACT
requirements for that CTG or non-CTG category; 3) Detailing the basis
for concluding that these regulations fulfill RACT through comparison
with established RACT requirements described in the CTG guidance
documents and rules developed by other state and local agencies; and 4)
Submitting negative declarations when there are no CTG or major Non-CTG
sources of VOC emissions within the HGB or DFW areas. Accordingly, we
are proposing that TCEQ's submittals for all affected VOC sources in
the HGB and DFW areas provide for the implementation of RACT.
    On October 5, 2005 (70 FR 58136), and September 6, 2006 (71 FR
52676) we approved RACT for all affected VOC and NOX sources
for the HGB area for the 1-Hour ozone NAAQS.

B. What Control Techniques Guidelines (CTG) source categories are we
addressing in this action?

    In prior actions for both the HGB and DFW areas for the 1997 8-Hour
ozone NAAQS, we approved several SIP revisions as meeting RACT.
    Under the 1997 8-hour ozone NAAQS, for the HGB area, we approved
SIP revisions as meeting RACT for all CTG source categories, and major
Non-CTG VOC sources, except for the 2006-2008 EPA-issued CTG series, in
the HGB area (designated as Severe) on April 2, 2013 (78 FR 19599), and
April 15, 2014 (79 FR 21144). Furthermore, we approved revisions to 30
TAC Chapter 117 as meeting RACT for emissions sources of NOX
in the HGB area (designated as Severe). See April 2, 2013 (78 FR
19599).
    As a part of DFW ozone attainment demonstration plan we approved
VOC RACT for the DFW designated as Moderate area. See January 14, 2009
(74 FR 1903).
    In this action, we are addressing additional source categories
affected by the newly EPA-issued CTGs for HGB (designated as Severe)
and DFW (designated as Serious) areas for the 1997 8-Hour ozone NAAQS,
as well as proposing to approve Texas' updated RACT analysis for the
remaining source categories in the DFW area.
    Table 1 below contains a list of CTG source categories, EPA
reference documents, and the corresponding sections of 30 TAC Chapter
115 that fulfill the applicable RACT requirements for these newly EPA-
issued CTGs.

Table 1--CTG Source Categories Issued by EPA in 2006-2008, EPA Reference
  Documents, and Corresponding Section of 30 TAC Chapter 115 Fulfilling
                                  RACT
------------------------------------------------------------------------
                                                         30 TAC Chapter
         CTG Category                EPA Reference       115 fulfilling
                                       documents              RACT
------------------------------------------------------------------------
Flat Wood Paneling Coatings...  Control Techniques      Negative
                                 Guidelines for Flat     Declarations in
                                 Wood Paneling           DFW and HGB.
                                 Coatings, (EPA-453/R-
                                 06-004-2006/09).
Flexible Packaging Printing     Control Techniques      Sections 115.430-
 Materials.                      Guidelines for          115.439.
                                 Flexible Package
                                 Printing, (EPA-453/R-
                                 06-003-2006/09).
Industrial Cleaning Solvents..  Control Techniques      Sections 115.460-
                                 Guidelines for          115.469.
                                 Industrial Cleaning
                                 Solvents, (EPA-453/R-
                                 06-001-2006/09).
Offset Lithographic and         Control Techniques      Sections 115.440-
 Letterpress Printing.           Guidelines for Offset   115.449 for
                                 Lithographic Printing   Offset
                                 and Letterpress         Lithographic
                                 Printing, (EPA-453/R-   Printing;
                                 06-002-2006/09).        Negative
                                                         Declarations
                                                         for Letterpress
                                                         Printing in HGB
                                                         and DFW.
Large Appliance Coatings......  Control Techniques      Sections 115.450-
                                 Guidelines for Large    115.459.
                                 Appliance Coatings,
                                 (EPA 453/R-07-004-
                                 2007/09).
Metal Furniture Coatings......  Control Techniques      Sections 115.450-
                                 Guidelines for Metal    115.459.
                                 Furniture Coatings,
                                 (EPA 453/R-07-005-
                                 2007/09).
Paper, Film, and Foil Coatings  Control Techniques      Sections 115.420-
                                 Guidelines for Paper,   115.429; and
                                 Film, and Foil          115.450-115.459
                                 Coatings, (EPA 453/R-   .
                                 07-003-2007/09).
Auto and Light-Duty Truck       Control Techniques      Negative
 Assembly Coatings.              Guidelines for          Declaration in
                                 Automobile and Light-   HGB; Sections
                                 Duty Truck Assembly     115.450-115.459
                                 Coatings, (EPA 453/R-   in DFW.
                                 08-006-2008/09).
Fiberglass Boat Manufacturing   Control Techniques      Negative
 Materials.                      Guidelines for          Declarations in
                                 Fiberglass Boat         DFW and HGB.
                                 Manufacturing
                                 Materials, (EPA 453/R-
                                 08-004-2008/09).
Miscellaneous Industrial        Group IV Issued by EPA  Sections 115.470-
 Adhesives.                      in 2008, Control        115.479.
                                 Techniques Guidelines
                                 for Miscellaneous
                                 Industrial Adhesives,
                                 (EPA 453/R-08-005-
                                 2008/09).

Miscellaneous Metal and         Control Techniques      Sections 115.450-
 Plastic Parts Coatings.         Guidelines for          115.459.
                                 Miscellaneous Metal
                                 and Plastic Parts
                                 Coatings, (EPA 453/R-
                                 08-003-2008/09).
------------------------------------------------------------------------

    The Flexographic and Rotogravure Printing sector was not
specifically identified in the April 15, 2014 (79 FR 21144) rulemaking
action for the HGB area. The 30 TAC Chapter 115 sections 430 through
439 fulfill the VOC control requirements for this particular sector.
For a section-by-section evaluation of this sector see part 1 of the
TSD. We are proposing to approve the VOC RACT for the Flexographic and
Rotogravure Printing operations in the HGB area.
    On August 4, 2014 (79 FR 45105) we approved RACT for the Offset
Lithographic Printing Operations in the DFW (Serious) and HGB (Severe)
areas. Also, see docket No. EPA-R06-OAR-2010-0332 at
www.regulations.gov.
    On September 9, 2014 (79 FR 53299) we approved revisions to 30 TAC
Chapter 115 for control of VOC emissions for storage tanks in the DFW
and HGB areas. In that rulemaking action, we also found that VOC
control requirements for the VOC storage tanks source category in the
DFW (Serious) and HGB (Severe) areas represent RACT. See docket No.
EPA-R06-OAR-2012-0096 at www.regulations.gov.

C. Are there negative declarations for sources of emissions within
these nonattainment areas?

    Yes, there are negative declarations associated with the VOC source
categories in the DFW and HGB areas.
    For the DFW area, Texas has declared that there are no fiberglass
boat manufacturing materials, ship building and ship repair coating,
leather tanning and finishing, surface coating for flat wood paneling,
vegetable oil manufacturing, plywood veneer dryers, rubber tire
manufacturing, and batch processes operations. We are proposing to
approve the VOC RACT negative declaration for these operations in the
DFW area. As such, TCEQ does not have to adopt VOC regulations relevant
to these source categories at this time for the DFW area. However, if a
major source of these categories locates in the DFW area in future,
then TCEQ will need to take appropriate regulatory measures.
    For the HGB area, on April 15, 2014 (79 FR 21144), we approved the
VOC RACT negative declarations for fiberglass boat manufacturing
materials, leather tanning and finishing, surface coating for flat wood
paneling, letterpress printing, automobile and light-duty truck
assembly coating, rubber tire manufacturing, and vegetable oil
manufacturing operations. Also, see 40 CFR 52.2270(e).

D. Is Texas' approach to RACT determination for VOC sources based on
their submittals acceptable?

    Yes, Texas' approach to RACT determination for VOC sources based on
their submittals is acceptable. In the TSD developed for this
rulemaking action, we evaluated the corresponding sections of 30 TAC
Chapter 115 for the source categories identified in Table 1 above in
the HGB and DFW areas, and have reviewed these sections against our
identified reference documents. In their submittals to EPA, TCEQ states
that it has reviewed the HGB and DFW VOC rules and certifies that they
satisfy RACT requirements for the 1997 8-Hour ozone standard by the
application of control technology that is reasonably available
considering technological and economic feasibility. With their
submittals TCEQ revised sections 115.422, 115.427, 115.429, 115.430,
115.432, 115.433, 115.435, 115.436, and 115.439; repealed section
115.437; and adopted new sections 115.431, 115.450, 115.451, 115.453-
115.455, 115.458-115.461, 115.463-115.465, 115.468-115.471, 115.473-
115.475, 115.478, and 115.479. For a section-by-section review of the
RACT-related provisions see parts 1 and 3 of the TSD.
    Under the RACT requirements for the 8-hour ozone NAAQS States must
assure that RACT is met, either through a certification that previously
required RACT controls represent RACT for 8-hour implementation
purposes, or through a new RACT determination. States may use existing
EPA guidance in making RACT determinations. See 70 FR 71617 (November
29, 2005). Texas submitted a RACT assessment with its SIP revisions,
and evaluated its existing RACT regulations to ascertain whether these
regulations constitute RACT for the new 8-hour ozone NAAQS. Texas' 8-
Hour ozone RACT SIP submittals are based on the determination that RACT
has been met either through a certification that previously required
RACT controls for the 1-hour ozone standard represent RACT for 8-hour
ozone implementation purposes or, where necessary, through a new RACT
evaluation for certain regulations or sources. Therefore, we are
proposing a determination that Texas rules meet the CAA's RACT
requirements for the 1997 8-Hour ozone NAAQS for both the HGB and DFW
areas. This determination is based on the November 29, 2005 (70 FR
71612) rulemaking, regarding permissible approaches for determining
whether a State's level of control meets RACT, in which EPA provided
guidance that a State's certification of its rules is sufficient or
acceptable for a finding that the rules satisfy the RACT requirements
for the 8-hour implementation purposes; the framework described in our
TSD; and section B (Certifications) of EPA's May 18, 2006 RACT Q and A
document that provides additional clarifications for the RACT SIPs. See
pages 4-5 of the May 18, 2006 guidance document. Consequently, by
implementing these control requirements (Chapter 115) Texas is
satisfying the RACT requirements for all affected VOC sources,
including the CTG source categories identified in Tables 1 of this
document, in the HGB and DFW areas under the 1997 8-Hour ozone
standard.

E. Is Texas' approach to RACT determination for NOX sources based on
their submittals acceptable?

    Yes, Texas' approach to RACT determination for NOX
sources based on their submittals is acceptable. The purpose of 30 TAC
Chapter 117 rules for the DFW area is to establish reasonable controls
on the emissions of ozone precursors. Texas has one of the most
stringent NOX control requirements designed for ozone
attainment reasons in the country. Texas has reviewed its
NOX rules and has certified that its rules satisfy RACT
requirements. According to the framework, certification, and the
approach described in section D above we are proposing to find that
Texas has RACT-level controls in place for all affected NOX
sources in the DFW area (Moderate and Serious) under the 1997 8-Hour
ozone standard. See part 4 of the TSD for more information.
    We approved that Texas has RACT-level controls in place for all
affected

NOX sources in the HGB area on April 2, 2013 (78 FR 19599).
Also, see 40 CFR 52. 2270(e).
    Taken together, we are proposing to find Texas has RACT-level
controls in place for all affected VOC and NOX sources in
the HGB and DFW areas under the 1997 8-Hour ozone standard.

III. Proposed Action

    We are proposing to approve rule revisions to sections 30 TAC
chapter 115.422, 115.427, 115.429, 115.430, 115.432, 115.433, 115.435,
115.436, and 115.439 implementing controls on the source categories of
Table 1 of this action.
    We are proposing to approve new sections 30 TAC chapter 115.431,
115.450, 115.451, 115.453-115.455, 115.458-115.461, 115.463-115.465,
115.468-115.471, 115.473-115.475, 115.478, and 115.479 implementing
controls on the source categories of Table 1 of this action.
    We are proposing to approve repeal of section 30 TAC chapter
115.437.
    We are proposing to find that for VOC CTG categories identified in
Table 1 Texas has RACT-level controls in place for the HGB and DFW
areas under the 1997 8-Hour ozone standard.
    We are proposing to find that Texas has RACT-level controls in
place for the Flexographic and Rotogravure Printing operations for the
HGB area.
    We are proposing to approve the negative declarations as explained
in section II(C) of this action.
    We are proposing to approve NOX RACT for the DFW area
under the 1997 8-Hour ozone standard.
    In consideration of the rule revisions proposed for approval in
this action, as well as the rule revisions previously approved, taken
together, we are proposing that with its rules in 30 TAC Chapters 115,
and 117 Texas is implementing RACT for all affected VOC and
NOX sources in the HGB and DFW areas under the 1997 8-Hour
ozone standard.
    We are proposing to approve these revisions in accordance with
sections 110, 182, and 183 of the federal CAA.
    The EPA had previously approved RACT for all affected
NOX sources for the HGB area under the 1997 8-Hour ozone
standard.
    The EPA had previously approved RACT for all affected VOC and
NOX sources into Texas' SIP under the 1-Hour ozone standard.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. If a portion of the plan revision meets
all the applicable requirements of this chapter and Federal
regulations, the Administrator may approve the plan revision in part.
42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions,
EPA's role is to approve state choices that meet the criteria of the
Act, and to disapprove state choices that do not meet the criteria of
the Act. Accordingly, this proposed action approves state law as
meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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 Clean Air Act;
     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); and
     is not approved to apply on any Indian reservation land 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 as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

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

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Hydrocarbons,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: January 9, 2015.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2015-00866 Filed 1-20-15; 8:45 am]
BILLING CODE 6560-50-P


future, investigators would regret that such data were not collected.
Biomonitoring data are useful because it can provide the physiological
link to the next processes occurring after exposure and will help
estimate total and cumulative exposures.  If a physiologically based
modeling approach is desired, repeat measurements are needed to provide
reliable physiology data, and will help ensure the data are useful in
the future.  Dr. Zhu stated that he was troubled by the sample sizes
described for this research.  Exposure is likely to be linear, but
sample size determination is based solely on this assumption of
linearity, and perhaps does not provide the best basis for sample or
cluster size estimation.  He added that collecting covariates (such as
use and application methods) is useful, but standards are required for
collection of those data.

Dr. Heeringa explained that these data will be used for evaluation in
the context of a general database that has information on a distribution
of exposures.  The arguments for biomonitoring and repeated measurements
are valid; however, most biomonitoring and physiological models are not
appropriate for these settings.  These are tier 1 or 2 screening studies
to determine if a significant risk exists.  Dr. Heeringa agreed that if
the interest was in developing physiological models, repeated
measurements were needed; however, measurements for such modeling
activities are more properly made under controlled laboratory
conditions, rather than in the field.  Dr. Chambers added that
pharmacokinetic-pharmacodynamic models are available only for a small
number of compounds and may not apply to all the compounds being
measured.  Dose applies to all compounds.  Dr. Brimijoin noted that if
passive dosimetry is performed in a reliable manner to monitor exposure,
biomonitoring can only be considered a supplemental tool that will
provide little information on absorption; if the dosimetry garments
function properly, most pesticide absorption/uptake will be blocked.
Dr. Brimijoin agreed with Dr. Heeringa concerning the issue of
developing pharmacokinetic-pharmacodynamic models; collecting
biomonitoring data for this is a sound idea, but should be performed in
a different setting.  Dr. Fenske stated that biomonitoring is important,
but the protocols reviewed in June 2006 called only for passive
dosimetry.  The task force chose specific compounds based on their low
toxicity, and good pharmacokinetic-pharmacodynamic models may not be
available for many of these.  The goal of this work is to collect good
quality exposure data across a number of scenarios for risk assessment
activities.  Validation of hand washing, face washing, biomonitoring, or
other exposure assessment techniques should be considered side studies.

Dr. Popendorf clarified questions concerning sample size.  He stated
that the design the SAP was shown estimated that five people in five
clusters for a given scenario was reasonable to achieve a precision
factor of 3.  A secondary goal of these analyses was to detect
linearity.  If linearity is not shown, it is true that data collected on
potential covariates likely will not help determine which covariates
correlate with variability.  The SAP suggested, that, as a backup to the
linearity assumption, some other hypotheses be developed in terms of the
major potential drivers for exposure in a given scenario and use the
covariate as a potential way to validate and use data in a regulatory
process.  He summarized that precision and linearity were the major
drivers for sample size determination.  Dr. Heeringa added that the SAP
understood that, if the linearity assumption does not hold, increased
sample size will be needed to retain the same level of precision.  The
SAP’s recommendation for this is to increase the number of clusters.
The Panel also recommended that assumptions be revisited as data are
gathered.

Dr. Brimijoin commented that in the statistical treatment of data, the
focus would be on multiple clusters with multiple individuals involving
a particular mode of application, regardless of the type of compound, or
also stratified by compound.  He stated that when he first saw the AHETF
protocols, he did not think the protocols included sufficient replicates
to be of use.  He asked whether data would be consolidated by putting
together information from different compounds, but that had the same
amount (milligrams) of active ingredient.  Dr. Fisher summarized that a
difficulty in review of this work seemed to be how to understand that
there is a great deal of information that cannot be specific.  The data
are needed, and there is no way to have a sample size large enough to
answer exposure questions for every ingredient, timeframe of exposure,
or application method.  A rationale is needed to determine which
covariates are most important.  Other questions concern the validity of
the assumption of a linear model and how the data can be used, given
this lack of specificity, the variability of ingredients, etc., to
support risk assessment activities.  Dr. Chambers stated that the
assumption is that the handling activity and formulation will determine
exposure.  The identity of the pesticide measured is less important; if
two pesticides have the same formulation and are handled in the same
amounts and in relatively the same manner, exposure will be similar.
These protocols are intended only to measure dose, not toxicity
equivalents.  Dr. Popendorf agreed, noting that the data would be used
only to assess exposure; absorption and toxic effect would be
chemical-specific.  Different formulations, i.e., liquid or powder,
will be measured separately.

Public Comments

Dr. Fisher invited oral public comment on the EPA FIFRA SAP January 2007
Report on Worker Exposure Methods.  No oral public comments were
received.

Board Discussion

Dr. Fisher asked Board members to respond to the question concerning
additional information needed for review of handler research in general
or individual protocols.  Dr. Fenske began, stating that the Board needs
information from EPA concerning the use of information in the re-entry
workers database, which has parallels to AHETF, for risk assessment
activities.  He also requested clarification of the definition of
“intentional exposure” versus “observational” research.  He
recommended consideration of the term “scripted” instead of
“intentional exposure,” because the exposure is not
“intentional” but is staged or modified to meet the practical
considerations of obtaining useful data.  The HSRB should discuss this
with EPA.  Dr. Fenske added that Mr. Jordan had indicated that
discussions on these terms were in progress at EPA, and perhaps could
share any relevant information concerning these matters.  Dr. Fenske
related other information requests, including a governing document, such
as that submitted to the SAP, or the joint document from EPA, California
EPA, and Health Canada, which aptly justified and explained data needs.
He also requested feedback on stated EPA plans for additional validation
studies to determine whether dermal exposure measurements underestimate
true exposure; broaden participation of the scientific community and
parties with direct interest, such as the labor community; and plans for
meeting the requirements of 40 CFR Part 26.

Dr. Lebowitz observed that his points had been expressed in the SAP
discussion, which also clarified many of his questions.  Concerning
additional information, Dr. Lebowitz stated that the Board did not yet
have a clear understanding of the study designs that would be employed
and final decisions regarding sample size, analyses, and handling
biases.  As a general recommendation, he suggested that the AHETF
attempt to save time and money by including appropriate studies in the
existing pesticide handlers exposure database in its own database.  He
added that he will be interested in seeing how the revised protocols
address issues, such as standardization of exposure monitoring, and
other subjects raised by the SAP.

Dr. Lehman-McKeeman stated that additional information was needed to
clarify how recognized covariates would be handled and integrated into
data analyses and how this would affect study design.  She also asked
for identification of the study director regarding who would approve a
study or oversee the execution of the studies.

Dr. Menikoff requested more discussion of how pesticides are chosen for
studies and how that changes conditions for workers.  He stated that
“intentional” exposure means exposure to a substance that would not
otherwise occur.  He inquired whether ethical justification was needed
to alter the pesticide used, and whether investigators could instead
locate a setting in which the desired pesticide already was in use; this
would help eliminate some ethical issues.

Dr. Chambers disagreed with comments on the definition of intentional
exposure.  In her opinion, EPA’s analysis of this issue should be
heard before the Board develops its own definition.  Dr. Fenske agreed,
adding that it is not the HSRB’s role to develop the definition, but
to provide advice.  He commented to Dr. Menikoff that, in his
understanding, the AHETF always attempts to find conditions that do not
have to be altered for research purposes, but this is limited by the
availability of analytical capabilities for a given compound.
Appropriate substitutes must sometimes be suggested.  Dr. Fenske also
addressed the issue of heat related illnesses.  The procedure for
collecting data places workers at risk for heat stress; Dr. Fenske asked
Dr. Menikoff if this was related to the idea of changing working
conditions.  Use of the dosimeter garments may decrease pesticide
exposure, but increase another type of hazard.  Dr. Menikoff responded
that this did meet his idea of changing conditions.  He added that he
was not debating whether the research fit within the applicable
statutes.  His recollection was that in many cases, the investigators
supplied the pesticide.  If this is the case, the investigators must
justify why they cannot find a location at which that pesticide already
is in use.  Dr. Fisher cautioned against assuming that use of a
different pesticide increases risk.

Dr. Fisher summarized the HSRB informational needs.  A plan similar to
that provided to the SAP is needed, not for critique, but to further
understanding of the AHETF.  Information also is needed concerning how
EPA will evaluate its linear model assumption, given the SAP’s
recommendations about evaluating this model during the data collection
process and identifying an alternate approach, if necessary.  The HSRB
members also asked for information concerning how sample size would be
determined; strategies for replacement of missing or partial data; a
statistical analysis plan; identification of covariates to be collected
and a rationale for emphasis on some covariates versus others;
assessment of the need for a subset of repeated measurements to control
for some variability; identification of the type of biomonitoring data
that would be collected as a check for passive dosimetry; information
concerning validation of data collection, entry, training at the site,
and identification of relevant IRBs; information on whether passive
dosimetry over- or under-estimates dosage and whether statistical
analyses or biomonitoring data will help determine if a bias exists;
information on sampling frame and where to focus data collection, based
on usage patterns for products; and a rationale for the use of
pesticides at each site if they differ from those normally used, to
inform ethics discussions on toxicity and side effects.

Dr. Lewis thanked the Board members for their work and EPA for preparing
the meeting.  He stated that the next HSRB meeting is tentatively
scheduled for June 27-29, 2007.

Dr. Fisher adjourned the meeting.

Respectfully submitted:

Paul I. Lewis, Ph.D.

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Celia B. Fisher, Ph.D.

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER:  The minutes of this public meeting reflect diverse
ideas and suggestions offered by Board members during the course of
deliberations within the meeting.  Such ideas, suggestions, and
deliberations do not necessarily reflect definitive consensus advice for
the Board members.  The reader is cautioned to not rely on the minutes
to represent final, approved, consensus advice and recommendations
offered to the Agency.  Such advice and recommendations may be found in
the final report prepared and transmitted to the EPA Science Advisor
following the public meeting.

Attachments

Attachment A 		List of HSRB Members

Attachment B 		Federal Register Notice Announcing Meeting

Attachment C 		Meeting Agenda

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

Celia B. Fisher, Ph.D.

Marie Ward Doty Professor of Psychology

Director, Center for Ethics Education

Fordham University

Bronx, NY

Vice Chair

William S. Brimijoin, Ph.D.

Chair and Professor

Molecular Pharmacology and Experimental Therapeutics

Mayo Foundation

Rochester, MN

Members

David C. Bellinger, Ph.D. *

Professor of Neurology

Harvard Medical School

Professor in the Department of Environmental Health

Harvard School of Public Health

Children's Hospital

Boston, MA

Alicia Carriquiry, Ph.D.

Professor

Department of Statistics

Iowa State University

Ames, IA

Gary L. Chadwick, PharmD, MPH, CIP

Associate Provost

Director, Office for Human Subjects Protection

University of Rochester

Rochester, NY

Janice Chambers, Ph.D., D.A.B.T.

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS

Richard Fenske, Ph.D., MPH

Professor

Department of Environmental and Occupational Health Sciences

University of Washington

Seattle, WA

Susan S. Fish, PharmD, MPH

Associate Professor, Biostatistics & Epidemiology

Boston University School of Public Health

Co-Director, MA in Clinical Investigation

Boston University School of Medicine

Boston, MA

Suzanne C. Fitzpatrick, Ph.D., DABT

Senior Science Policy Analyst

Office of the Commissioner

Office of Science and Health Coordination

U.S. Food and Drug Administration

Rockville, MD

KyungMann Kim, Ph.D., CCRP

Professor and Associate Chair

Department of Biostatistics & Medical Informatics

School of Medicine and Public Health

University of Wisconsin-Madison

Madison, WI

Kannan Krishnan, Ph.D.

Professor

Département de santé environnementale et santé au travail

Faculté de médicine

Université de Montréal

Montréal, QC  Canada

Michael D. Lebowitz, Ph.D., FCCP

Professor of Public Health & Medicine

University of Arizona

Tucson, AZ

Lois D. Lehman-Mckeeman, Ph.D.

Distinguished Research Fellow, Discovery Toxicology

Bristol-Myers Squibb Company

Princeton, NJ

Jerry A. Menikoff, M.D.

Associate Professor of Law, Ethics & Medicine

Director of the Institute for Bioethics, Law and Public Policy

University of Kansas Medical Center

Kansas City, KS

Sean M. Philpott, Ph.D.

Policy and Ethics Director

Global Campaign for Microbicides

Program for Appropriate Technology in Health

Washington, DC

Richard Sharp, Ph.D.

Assistant Professor of Medicine

Center for Medical Ethics and Health Policy

Baylor College of Medicine

Houston, TX

* Not in attendance

Attachment B

Federal Register Notice Announcing Meeting

Human Studies Review Board; Notice of Public Meeting

[Federal Register: March 26, 2007 (Volume 72, Number 57)]

[Notices]

[Page 14101-14103]

[DOCID:E7-5492]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0216; FRL-8291-4]

Human Studies Review Board; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency)
Office of the Science Advisor (OSA) announces a public meeting of the
Human Studies Review Board (HSRB) to advise the Agency on EPA's
scientific and ethical reviews of human subjects' research.

DATES: The public meeting will be held on April 18, 2007 from 10 a.m. to
approximately 5:30 p.m., Eastern Time and April 19-20, 2007 from 8:30
a.m. to approximately 5:30 p.m., Eastern Time.

LOCATION: Environmental Protection Agency, Conference Center—Lobby
Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington,
VA  22202.

MEETING ACCESS: Seating at the meeting will be on a first-come basis. To
request accommodation of a disability please contact the person listed
under FOR FURTHER INFORMATION CONTACT at least 10 business days prior to
the meeting, to allow EPA as much time as possible to process your
request.

PROCEDURES FOR PROVIDING PUBLIC INPUT: Interested members of the public
may submit relevant written or oral comments for the HSRB to consider
during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Unit I.D.
of this notice.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Paul Lewis, EPA, Office of the
Science Advisor, (8105R), Environmental Protection Agency, 1200
Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (202)
564-8381; fax:<PHONE_NUMBER>; e-mail address:   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>. General information
concerning the EPA HSRB can be found on the EPA Web site at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/ .

ADDRESSES: Submit your written comments, identified by Docket ID No.

EPA-HQ-ORD-2007-0216, by one of the following methods:

    Internet:   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov : Follow the on-line instructions for

	submitting comments.

    E-mail:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),

ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW, Washington, DC
 20460.

    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA

Headquarters Library, Room Number 3334 in the EPA West Building, located
at 1301 Constitution Ave., NW, Washington DC. The hours of

	operation are 8:30 AM to 4:30 PM Eastern Standard Time (EST), Monday

	through Friday, excluding Federal holidays. Please call<PHONE_NUMBER>

or email the ORD Docket at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>for instructions. Updates to Public Reading Room
access are available on the Web site

	(  HYPERLINK "http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm ).

    Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2007-0216. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or e-mail. The
  HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
Web site is an “anonymous access” system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA,
without going through   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

SUPPLEMENTARY INFORMATION:

I. Public Meeting

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies,
especially studies on substances regulated by EPA or to persons who are
or may be required to conduct testing of chemical substances under the
Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of This Document and Other Related
Information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the

“Federal Register” listings at   HYPERLINK
"http://www.epa.gov/fedrgstr/"  http://www.epa.gov/fedrgstr/ .

Docket: All documents in the docket are listed in the

  HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
index. Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, will
be publicly available only in hard copy.  Publicly available docket
materials are available either electronically in   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or in hard
copy at the ORD Docket, EPA/DC, Public Reading Room. The EPA/DC Public
Reading Room is located in the EPA Headquarters Library, Room Number
3334 in the EPA West Building, located at 1301 Constitution Ave., NW,
Washington DC. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern
Standard Time, Monday through Friday, excluding Federal holidays. Please
call<PHONE_NUMBER> or e-mail the ORD Docket at   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>for instructions.
Updates to Public Reading Room access are available on the Web site (
HYPERLINK "http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm ).

    EPA's position paper(s), charge/questions to the HSRB, and the
meeting agenda will be available by late March 2007. In addition, the
Agency may provide additional background documents as the materials
become available. You may obtain electronic copies of these documents,
and certain other related documents that might be available
electronically, from the regulations.gov Web site and the HSRB Internet
Home Page at   HYPERLINK "http://www.epa.gov/osa/hsrb/"
http://www.epa.gov/osa/hsrb/ . For questions on document availability or
if you do not have access to the Internet, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

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

    You may find the following suggestions helpful for preparing your
comments:

    a. Explain your views as clearly as possible.

    b. Describe any assumptions that you used.

    c. Provide copies of any technical information and/or data you used
that support your views.

    d. Provide specific examples to illustrate your concerns and suggest
alternatives.

    e. To ensure proper receipt by EPA, be sure to identify the docket

ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal

Register citation.

D. How May I Participate in this Meeting?

    You may participate in this meeting by following the instructions in
this section. To ensure proper receipt by EPA, it is imperative that you
identify docket ID number EPA-HQ-ORD-2007-0216 in the subject line on
the first page of your request.

    a. Oral comments. Requests to present oral comments will be accepted
up to April 11, 2007. To the extent that time permits, interested
persons who have not pre-registered may be permitted by the Chair of the
HSRB to present oral comments at the meeting. Each individual or group
wishing to make brief oral comments to the HSRB is strongly advised to
submit their request (preferably via email) to the person listed under
FOR FURTHER INFORMATION CONTACT no later than noon, Eastern Standard
Time, April 11, 2007 in order to be included on the meeting agenda and
to provide sufficient time for the HSRB Chair and HSRB Designated
Federal Officer (DFO) to review the agenda to provide an appropriate
public comment period. The request should identify the name of the
individual making the presentation, the organization (if any) the
individual will represent, and any requirements for audiovisual
equipment (e.g., overhead projector, LCD projector, chalkboard). Oral
comments before the HSRB are limited to five minutes per individual or
organization. Please note that this limit applies to the cumulative time
used by all individuals appearing either as part of, or on behalf of an
organization. While it is

our intent to hear a full range of oral comments on the science and
ethics issues under discussion, it is not our intent to permit
organizations to expand these time limitations by having numerous
individuals sign up separately to speak on their behalf. If additional
time is available, there may be flexibility in time for public comments.
Each speaker should bring 25 copies of his or her comments and
presentation slides for distribution to the HSRB at the meeting.

    b. Written comments. Although you may submit written comments at any
time, for the HSRB to have the best opportunity to review and consider
your comments as it deliberates on its report, you should submit your
comments at least five business days prior to the beginning of the
meeting. If you submit comments after this date, those comments will be
provided to the Board members, but you should recognize that the Board
members may not have adequate time to consider those comments prior to
making a decision. Thus, if you plan to submit written comments, the
Agency strongly encourages you to submit such comments no later than
noon, Eastern Standard Time, April 11, 2007. You should submit your
comments using the instructions in Unit I.C. of this notice. In
addition, the Agency also requests that person(s) submitting comments
directly to the docket also provide a copy of their comments to the
person listed under FOR FURTHER INFORMATION CONTACT. There is no limit
on the length of written comments for consideration by the HSRB.

E. Background

A. Topics for Discussion

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act (FACA) 5 U.S.C. app.2 section 9.
The HSRB provides advice, information, and recommendations to EPA on
issues related to scientific and ethical aspects of human subjects
research. The major objectives of the HSRB are to provide advice and
recommendations on: (a) Research proposals and protocols; (b) reports of
completed research with human subjects; and (c) how to strengthen
EPA’s programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through EPA’s Science Advisor.

    At the April 2007 meeting of the HSRB, EPA will present for HSRB
review:

    • The results of two completed insect repellent efficacy studies
on an aerosol formulation of the active ingredient IR3535, studies which
the Agency intends to rely in making registration decisions. Protocols
for this research were reviewed by the Board at its June and October
2006 meetings.

A proposal for a new field study of the effectiveness of products
containing oil of lemon eucalyptus in repelling mosquitoes.

    • Completed studies of human skin irritation and skin
sensitization on two pending pesticide products whose use would involve
extensive dermal exposure. These studies were conducted before the
effective date of EPA’s human studies rules (April 7, 2006).

    • EPA’s assessment of the need for new research on the exposure
received by occupational handlers who mix, load, or apply agricultural
or antimicrobial pesticides.

    • An EPA “draft framework” concerning best practices for
recruiting and enrolling subjects in studies of occupational exposure.

    In addition, at the Board’s request, EPA will present its
interpretation and application of the standard in 40 CFR 26.1705: “EPA
shall not rely on data from any research initiated after April 7, 2006,
unless EPA has adequate information to determine that the research was
conducted in substantial compliance with [EPA’s human studies
rules].” Finally, the Board may also discuss planning for future HSRB
meetings.

B. Meeting Minutes and Reports

    Minutes of the meeting, summarizing the matters discussed and
recommendations, if any, made by the advisory committee regarding such
matters will be released within 90 calendar days of the meeting. Such
minutes will be available at   HYPERLINK "http://www.epa.gov/osa/hsrb/"
http://www.epa.gov/osa/hsrb/  and   HYPERLINK "

http://www.regulations.gov"

http://www.regulations.gov .  In addition, information concerning a
Board meeting report, if applicable, can be found at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/  or from
the person listed under FOR FURTHER INFORMATION CONTACT.

Dated: March 19, 2007.

George M. Gray,

Science Advisor

[FR Doc. E7-5492 Filed 3-23-07; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC MEETING

APRIL 18-20, 2007*

ONE POTOMAC YARD

ARLINGTON, VA

HSRB Web Site: http://www.epa.gov/osa/hsrb/

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-ORD-2007-0216

Wednesday, April 18, 2007

10:00 a.m.	Convene Meeting and Identification of Board Members

		Celia Fisher, Ph.D. (HSRB Chair)

10:15 a.m.	Welcome

	Warren Lux, MD (Human Subjects Research Review Official, Office of the
Science Advisor, EPA)

10:25 a.m.	Opening Remarks

			Mr. Jim Jones (Principal Deputy Assistant Administrator, Office of

			Prevention, Pesticides, and Toxic Substances, EPA) and

			Debbie Edwards, Ph.D. (Director, Office of Pesticide Programs)

10:40 a.m.	Meeting Administrative Procedures

		Paul Lewis, Ph.D. (Designated Federal Officer [DFO], HSRB, OSA, EPA)

10:45 a.m.	Meeting Process

		Celia Fisher, Ph.D. (HSRB Chair)

10:55 a.m.	EPA Follow-up on HSRB Recommendations

		Mr. William Jordan (EPA, OPP)

Completed Repellent Efficacy Studies: IR3535 Aerosol (EMD-003.3 and
EMD-004.3)

11:10 a.m.	Science and Ethics of Repellent Efficacy Studies

		Clara Fuentes, Ph.D. (OPP, EPA) and Mr. John Carley (OPP, EPA)

11:50 a.m.	Public Comments

12:15 p.m.	Lunch

1:15 p.m.	Board Discussion

EMD-003.3: Tick Repellency with Aerosol Spray Formulations

a.	Is this study sufficiently sound, from a scientific perspective, to
be used to assess the repellent efficacy of the formulation tested
against ticks?

b.	Does available information support a determination that this study
was conducted in substantial compliance with subparts K and L of EPA
regulations at 40 CFR part 26?

EMD-004.3: Mosquito Repellency with Aerosol Spray Formulations

a.	Is this study sufficiently sound, from a scientific perspective, to
be used to assess the repellent efficacy of the formulation tested
against mosquitoes?

b.	Does available information support a determination that this study
was conducted in substantial compliance with subparts K and L of EPA
regulations at 40 CFR part 26?

Carroll-Loye Mosquito Repellent Efficacy Protocol WPC-001

2:15 p.m.	Science and Ethics of Protocol WPC-001

		Clara Fuentes, Ph.D. (OPP, EPA) and Mr. John Carley (OPP, EPA)

3:00 p.m.	Break

3:15 p.m.	Public Comments

3:40 p.m.	Board Discussion

a.	If the proposed research described in Protocol WPC-001 from
Carroll-Loye Biological Research is revised as suggested in EPA’s
review, does the research appear likely to generate scientifically
reliable data, useful for assessing the efficacy of the test substances
for repelling mosquitoes?

If the proposed research described in Protocol WPC-001 from Carroll-Loye
Biological

Research is revised as suggested in EPA’s review, does the research
appear to meet the applicable requirements of 40 CFR part 26, subparts K
and L?

Research Conducted After April 7, 2006: Meaning of “Substantial
Compliance” with 40

CFR Part 26

4:40 p.m.	Meaning of “Substantial Compliance”

		Mr. William Jordan (OPP, EPA) and Mr. Keith Matthews (OGC, EPA)

5:00 p.m.	Public Comment

5:20 p.m.	Board Discussion

6:00 p.m.	Adjournment

Thursday, April 19, 2007

8:30 a.m.	Convene Meeting

		Celia Fisher, Ph.D. (HSRB Chair)

8:40 a.m.	Follow-up From Previous Day’s Discussion

		Mr. William Jordan (OPP, EPA)

Completed Patch Test Studies

8:50 a.m.	HSRB Workgroup and EPA Process on CBI Redacted Submissions

		Celia Fisher, Ph.D. (HSRB Chair) and Mr. William Jordan (OPP, EPA)

Part I. 48-Hour Dermal Irritation Patch Test

9:00 a.m.	Science and Ethics of 48 Hour Dermal Irritation Patch Test

		Roger Gardner, Ph.D. (OPP, EPA) and Mr. John Carley (OPP, EPA)

10:00 a.m.	Public Comments

10:30 a.m.	Break

10:45 a.m.	Board Discussion

a.   Is this study sufficiently sound, from a scientific perspective, to
be used as part of a

weight-of-evidence assessment to evaluate the potential of the
formulations tested to irritate human skin?

b.   Is there clear and convincing evidence that the conduct of this
study was fundamentally

unethical or significantly deficient relative to the ethical standards
prevailing at the time the research was conducted?

12:15 p.m.	Lunch

Part II. Repeated Insult Patch Test

1:30 p.m.	Science and Ethics of Repeated Insult Patch Test

		Roger Gardner, Ph.D. (OPP, EPA) and Mr. John Carley (OPP, EPA)

2:15 p.m.	Public Comments

2:45 p.m.	Board Discussion

Is this study sufficiently sound, from a scientific perspective, to be
used as part of a

weight-of-evidence assessment to evaluate the potential of the
formulations tested to cause sensitization of human skin?

Is there clear and convincing evidence that the conduct of this study
was fundamentally

unethical or significantly deficient relative to the ethical standards
prevailing at the time the research was conducted?

3:45 p.m.	Break

Framework for Developing Best Practices for Subject Recruitment for
Handler Exposure

Research

4:00 p.m.	Framework for Developing Best Practices for Subject
Recruitment for Handler Exposure Research

		Mr. John Carley (OPP, EPA)

4:30 p.m.	Public Comments

4:45 p.m.	Board Discussion

a.	What additional elements of the process of recruiting and enrolling
subjects in handler

exposure research should be addressed in a “Best Practices
Framework”?

For each of the elements in the “Best Practices Framework,” please
identify any

additional sources of guidance that could be useful for an investigator
who is designing a process for recruiting and enrolling subjects in
handler exposure research.

5:45 p.m.	Adjournment

Friday, April 20, 2007

8:30 a.m.	Convene Meeting

			Celia Fisher, Ph.D. (HSRB Chair)

8:40 a.m.	Follow-up From Previous Day’s Discussion

			Mr. William Jordan (OPP, EPA)

Follow-up on AHETF and AEATF Protocols

8:50 a.m.	EPA’s Need for New Research on Occupational Handler Exposure

	Mr. William Jordan (OPP, EPA), Mr. Jeff Evans (OPP, EPA), Mr. Jeff
Dawson (OPP, EPA), and Mr. Matthew Crowley (OPP, EPA)

10:00 a.m.	Break

10:15 a.m.	EPA’s Need for New Research on Occupational Handler
Exposure

	(continued)

		Mr. William Jordan (OPP, EPA), Mr. Jeff Evans (OPP, EPA), Mr. Jeff

		Dawson (OPP, EPA), and Mr. Matthew Crowley (OPP, EPA)

11:15 a.m.	Summary of EPA FIFRA SAP January 2007 Report “Worker
Exposure Methods”

		FIFRA SAP Chair and/or Designee

11:45 a.m.	Public Comments

12:15 p.m.	Lunch

1:15 p.m.	Board Discussion

Recognizing that protocol-specific science and ethics issues will be
addressed in later HSRB meetings, EPA has attempted to explain the basis
for its conclusion that additional information on exposure for people
who mix, load, and apply pesticides (handlers) would be useful in EPA's
regulatory decision-making and therefore new research would be valuable.
 Do the materials provided by EPA regarding the quality of the
scientific data currently available for assessing exposures for handlers
contain useful information to establish the societal value of proposed
new handler exposure research, assuming individual protocols would
generate scientifically valid information?

What additional information, if any, would the Board want with respect
either to handler research in general or to individual protocols?

2:15 p.m.	Adjournment

Please be advised that agenda times are approximate and subject to
change. For further information, please contact the Designated Federal
Officer for this meeting, Paul Lewis via telephone:<PHONE_NUMBER> or
email:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

 PAGE

  PAGE  1  of   NUMPAGES  91


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Rules and Regulations]
[Pages 10242-10244]
[FR Doc No: 2023-03399]

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

40 CFR Part 180

[EPA-HQ-OPP-2021-0658; FRL-10474-01-OCSPP]

Penthiopyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
penthiopyrad in or on banana. Interregional Research Project Number 4,
IR-4, requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 17, 2023. Objections and
requests for hearings must be received on or before April 18, 2023, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0658, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>.
    For the latest status information on EPA/DC services, docket
access, visit https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov//title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0658 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
April 18, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0658, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 17, 2022 (87 FR 68959) (FRL-
9410-07-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1E8951) by IR-4, NC State University, 1730 Varsity Drive,
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that
40 CFR 180.658 be amended to establish a tolerance for residues of the
fungicide penthiopyrad, N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-
(trifluoromethyl)-1H-pyrazole-4-carboxamide, in or on banana at 2 parts
per million (ppm). That document referenced a summary of the petition
prepared by IR-4, the petitioner, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the Notice of Filing.
    Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing the tolerance for residues of penthiopyrad in or on
banana at a different level than requested by the petitioner. The
reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''

    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for penthiopyrad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with penthiopyrad follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking and republishing the same sections is unnecessary.
EPA considers referral back to those sections as sufficient to provide
an explanation of the information EPA considered in making its safety
determination for the new rulemaking.
    EPA has previously published a number of tolerance rulemakings for
penthiopyrad, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to penthiopyrad and established a
tolerance for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological
Profile of penthiopyrad, see Unit III.A. of the June 6, 2019,
rulemaking (84 FR 26352) (FRL-9994-08).
    Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
penthiopyrad used for human risk assessment, see Unit III.B. of the
June 6, 2019, rulemaking.
    Exposure assessment. Much of the exposure assessment remains the
same although updates have occurred to accommodate exposures from the
petitioned-for tolerance. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, please reference Unit III.C. of the June
6, 2019, rulemaking.
    EPA's dietary exposure assessments have been updated to include the
additional exposure from the new use of penthiopyrad on banana and were
conducted with Dietary Exposure Evaluation Model software using the
Food Commodity Intake Database (DEEM-FCID) Version 4.02, which uses the
2005-2010 food consumption data from the United States Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). The assessment used the
same assumptions as the June 6, 2019, final rule concerning tolerance-
level residues, default processing factors for all processed
commodities and 100 percent crop treated.
    Drinking water exposure. The drinking water numbers have not
changed since the June 6, 2019, rulemaking.
    Non-occupational exposure. There are no new residential (non-
occupational) exposures associated with the new proposed use. The
assessment of exposures to the currently registered uses on residential
sites (e.g., lawns and turf) has not changed since the June 6, 2019,
rulemaking.
    Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to penthiopyrad and any other substances and
penthiopyrad does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that penthiopyrad has a common mechanism of toxicity with
other substances.
    Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.D. of the June 6, 2019, rulemaking for a discussion of the Agency's
rationale for that determination.
    Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population adjusted dose (aPAD)
and the chronic population adjusted dose (cPAD). Short-, intermediate-,
and chronic term risks are evaluated by comparing the estimated
aggregate food, water, and residential exposure to the appropriate
points of departure to ensure that an adequate margin of exposure (MOE)
exists. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
    Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 21% of the aPAD for all infants (less than 1 year
old), the population subgroup with the highest exposure estimate.
Chronic dietary risks are below the Agency's level of concern of 100%
of the cPAD; they are 38% of the cPAD for all infants (less than 1 year
old), the population subgroup with the highest exposure estimate.
    The combined short-term food, water, and residential exposures
result in aggregate MOEs of 440 in adults and 220 for children 1 to <2
years old. Because EPA's level of concern for penthiopyrad is an MOE of
100 or below, these MOEs are not of concern. For more details, refer to
unit III.E in the June 6, 2019, rulemaking and unit III.B of the April
7, 2021, rulemaking (86 FR 17917) (FRL-10017-27). As explained in unit
III.E. in the June 6, 2019, rulemaking, EPA has concluded that the
cancer risk is not of concern. Based on the risk assessments and
information described above, EPA concludes there is reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to penthiopyrad residues.
More detailed information can be found at https://www.regulations.gov
in the document titled ``Penthiopyrad. Human Health Risk Assessment for
the Proposed Registrations on Bananas and Greenhouse-Grown Lettuce'' in
docket ID number EPA-HQ-OPP-2021-0658.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method,
see Unit IV.A. of the June 6, 2019, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
    The Codex has not established an MRL for residues of penthiopyrad
in or on banana.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance for residues of penthiopyrad in
or on bananas at 3 ppm instead of the petitioner-proposed 2 ppm. The 2
ppm value is likely the result of the Day 0 residues input into the
Organization for Economic Cooperation and Development (OECD) tolerance
calculator. However, in the residue decline trial, the residue on Day 0
(0.98 ppm) increased on Day 1 (1.11 ppm) before declining for the
remainder of the study. As the Day 1 harvest is allowable according to
the proposed application pattern, it is EPA's practice to use that
value instead of the Day 0 value. This input results in a tolerance of
3 ppm according to the OECD tolerance calculation procedures.

V. Conclusion

    Therefore, a tolerance is established for residues of penthiopyrad,
including its metabolites and degradates, in or on banana at 3 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides, and pests, Reporting and
recordkeeping requirements.

    Dated: February 14, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA amends 40
CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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

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

0
2. In Sec.  180.658, amend table 1 to paragraph (a)(1) by adding, in
alphabetical order, an entry for ``Banana'' to read as follows:

Sec.  180.658   Penthiopyrad; tolerances for residues.

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

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Banana.....................................................           3

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

* * * * *
[FR Doc. 2023-03399 Filed 2-16-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50823-50824]
[FR Doc No: 2019-20912]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14971-000]

Lock+\TM\ Hydro Friends Fund XVIII, LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

    On March 1, 2019, Lock+\TM\ Hydro Friends Fund XVIII, LLC, filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Union City Dam Hydropower Project to be located at the U.S. Army Corps
of Engineers' (Corps) Union City Dam on French Creek in Erie County,
Pennsylvania. The sole purpose of a preliminary permit, if issued, is
to grant the permit holder priority to file a license application
during the permit term. A preliminary permit does not authorize the
permit holder to perform any land-disturbing activities or otherwise
enter upon lands or waters

owned by others without the owners' express permission.
    The proposed project would consist of the following: (1) A new 30-
foot-wide, 30-foot-deep, 160-foot-tall modular frame structure to be
installed at the intake for the outlet pipe adjacent to the outlet
tower, containing two turbine-generator units with a rated capacity of
1,200 kilowatts each; (2) a new switchgear and control room located in
the modular structure; and (3) a new 13-kilovolt transmission line
connecting the modular structure with a nearby existing electrical
grid. The proposed project would have an annual generation of 10,500
megawatt-hours.
    Applicant Contact: Wayne Crouse, Lock+\TM\ Hydro Friends Fund
XVIII, LLC, P.O. Box 43796, Birmingham, AL 35243; phone:<PHONE_NUMBER>,
ext. 709.
    FERC Contact: Monir Chowdhury; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-14971-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14971) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: September 20, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-20912 Filed 9-25-19; 8:45 am]
 BILLING CODE 6717-01-P