[Federal Register Volume 88, Number 45 (Wednesday, March 8, 2023)]
[Rules and Regulations]
[Pages 14280-14290]
[FR Doc No: 2023-04376]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2021-0133; FRL-8473-03-OAR]
RIN 2060-AV27

National Emission Standards for Hazardous Air Pollutants: Wood
Preserving Area Sources Technology Review; Technical Correction for
Surface Coating of Wood Building Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This action finalizes the technology review (TR) conducted for
the Wood Preserving Area Sources category regulated under national
emission standards for hazardous air pollutants (NESHAP). While the
Environmental Protection Agency (EPA) is making no changes to the
existing standards as a result of the TR, this action establishes minor
editorial and formatting changes to the Wood Preserving Area Sources
NESHAP table of applicable general provisions. In addition, the EPA is
finalizing technical corrections to the Surface Coating of Wood
Building Products NESHAP.

DATES: This final rule is effective on March 8, 2023.

ADDRESSES: The U.S. Environmental Protection Agency (EPA) has
established a docket for this action under Docket ID No. EPA-HQ-OAR-
2021-0133. All documents in the docket are listed on the https://www.regulations.gov/ website. Although listed, some information is not
publicly available, e.g., Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
through https://www.regulations.gov/, or in hard copy at the EPA Docket
Center, WJC West Building, Room Number 3334, 1301 Constitution Ave. NW,
Washington, DC. The Public Reading Room hours of operation are 8:30
a.m. to 4:30 p.m. Eastern Standard Time (EST), Monday through Friday.
The telephone number for the Public Reading Room is<PHONE_NUMBER>, and
the telephone number for the EPA Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Cyrus Ma, Sector Policies and
Programs Division (mail code E143-03), Office of Air Quality Planning
and Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina 27711; telephone number:<PHONE_NUMBER>; and email
address: [email protected].

SUPPLEMENTARY INFORMATION:
    Preamble acronyms and abbreviations. Throughout this preamble the
use of ``we,'' ``us,'' or ``our'' is intended to refer to the EPA. We
use multiple acronyms and terms in this preamble. While this list may
not be exhaustive, to ease the reading of this preamble and for
reference purposes, the EPA defines the following terms and acronyms
here:

CAA Clean Air Act
CBI Confidential Business Information
CCA Chromated Copper Arsenate
CFR Code of Federal Regulations
CRA Congressional Review Act
EJ Environmental Justice
EPA Environmental Protection Agency
EST Eastern Standard Time
GACT Generally Available Control Technology
HAP Hazardous Air Pollutant(s)
KM Kilometer

MACT Maximum Achievable Control Technology
NESHAP National Emission Standards for Hazardous Air Pollutants
NTTAA National Technology Transfer and Advancement Act
OCSPP Office of Chemical Safety and Pollution Prevention
OMB Office of Management and Budget
OSHA Occupational Safety and Health Administration
PRA Paperwork Reduction Act
RFA Regulatory Flexibility Act
TR Technology Review
UMRA Unfunded Mandates Reform Act

    Background information. On March 7, 2022, the EPA proposed
revisions to the Wood Preserving Area Sources NESHAP based on our TR.
In this action, we are finalizing decisions and revisions for the rule.
We summarize comments we received regarding the proposed rule and
provide our responses in this preamble. A ``track changes'' version of
the regulatory language that incorporates the changes in this action is
available in the docket (docket ID No. EPA-HQ-OAR-2021-0133).
    Organization of this document. The information in this preamble is
organized as follows:

I. General Information
    A. Does this action apply to me?
    B. Where can I get a copy of this document and other related
information?
    C. Judicial Review and Administrative Reconsideration
II. Background
    A. What is the statutory authority for this action?
    B. What is the Wood Preserving Area Sources source category and
how does the NESHAP regulate HAP emissions from the source category?
    C. What changes did we propose for the Wood Preserving Area
Sources source category in our March 7, 2022, proposal?
III. What is included in this final rule?
    A. What are the final rule amendments based on the technology
review for the Wood Preserving Area Sources source category?
    B. What other changes are we finalizing in the NESHAP for Wood
Preserving Area Sources?
    C. What are the technical corrections to the NESHAP for Surface
Coating of Wood Building Products?
IV. What is the rationale for our final decisions and amendments for
the Wood Preserving Area Sources source category and the technical
corrections to the NESHAP for Surface Coating of Wood Building
Products?
    A. Technology Review for the Wood Preserving Area Sources Source
Category
    1. What did we propose pursuant to CAA section 112(d)(6) for the
Wood Preserving Area Sources source category?
    2. How did the TR change for the Wood Preserving Area Sources
source category?
    3. What comments did we receive on the TR, and what are our
responses?
    4. What is the rationale for our final approach for the TR?
    B. Changes to Wood Preserving Area Sources NESHAP Table 1 to
Subpart QQQQQQ of Part 63--Applicability of General Provisions to
Subpart QQQQQQ
    1. What changes did we propose to Table 1 to Subpart QQQQQQ of
Part 63--Applicability of General Provisions to Subpart QQQQQQ?
    2. How did revisions in the final action change Table 1 to
Subpart QQQQQQ of Part 63--Applicability of General Provisions to
Subpart QQQQQQ?
    3. What comments did we receive on the proposed changes to Table
1 to Subpart QQQQQQ of Part 63--Applicability of General Provisions
to Subpart QQQQQQ, and what are our responses?
    4. What is the rationale for our final approach for the changes
to Table 1 to Subpart QQQQQQ of Part 63--Applicability of General
Provisions to Subpart QQQQQQ?
    C. Technical Corrections to the NESHAP for Surface Coating of
Wood Building Products
    1. What technical corrections were proposed to the NESHAP for
Surface Coating of Wood Building Products?
    2. How did the technical corrections to the NESHAP for Surface
Coating of Wood Building Products change?
    3. What comments did we receive on the technical corrections to
the NESHAP for Surface Coating of Wood Building Products?
    4. What is the rationale for our final approach for the
technical corrections to the NESHAP for Surface Coating of Wood
Building Products?
V. Summary of Cost, Environmental, and Economic Impacts and
Additional Analyses Conducted
    A. What are the affected facilities?
    B. What are the air quality impacts?
    C. What are the cost impacts?
    D. What are the economic impacts?
    E. What are the benefits?
    F. What analysis of environmental justice did we conduct?
    G. What analysis of children's environmental health did we
conduct?
VI. Statutory and Executive Order Reviews
    A. Executive Orders 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act (CRA)

I. General Information

A. Does this action apply to me?

    Regulated entities. Categories and entities potentially regulated
by this action are shown in Table 1 of this preamble.

                 Table 1--NESHAP and Industrial Source Categories Affected by This Final Action
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                   NESHAP                                Source category                   NAICS \1\ code
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40 CFR part 63, subpart QQQQQQ..............  Wood Preserving Area Sources........                       321114.
40 CFR part 63, subpart QQQQ................  Surface Coating of Wood Building           321211, 321212, 321218,
                                               Products.                                 321219, 321911, 321999.
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\1\ North American Industry Classification System.

    Table 1 of this preamble is not intended to be exhaustive, but
rather to provide a guide for readers regarding entities likely to be
affected by the final action for the source category listed. To
determine whether your facility is affected, you should examine the
applicability criteria in the appropriate NESHAP. If you have any
questions regarding the applicability of any aspect of this NESHAP,
please contact the appropriate person listed in the preceding FOR
FURTHER INFORMATION CONTACT section of this preamble.

B. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this final action will also be available on the internet. Following
signature by the EPA Administrator, the EPA will post a

copy of this final action at: https://www.epa.gov/stationary-sources-air-pollution/wood-preserving-area-sources-national-emission-standards-hazardous. Following publication in the Federal Register, the EPA will
post the Federal Register version and key technical documents at this
same website.
    Additional information is available at https://www.epa.gov/stationary-sources-air-pollution/wood-preserving-area-sources-national-emission-standards-hazardous. This information includes a summary of
the NESHAP, links to the various regulatory actions for the source
category, and other related documents.

C. Judicial Review and Administrative Reconsideration

    Under Clean Air Act (CAA) section 307(b)(1), judicial review of
this final action is available only by filing a petition for review in
the United States Court of Appeals for the District of Columbia Circuit
(the Court) by May 8, 2023. Under CAA section 307(b)(2), the
requirements established by this final rule may not be challenged
separately in any civil or criminal proceedings brought by the EPA to
enforce the requirements.
    Section 307(d)(7)(B) of the CAA further provides that only an
objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review. This section also
provides a mechanism for the EPA to reconsider the rule if the person
raising an objection can demonstrate to the Administrator that it was
impracticable to raise such objection within the period for public
comment or if the grounds for such objection arose after the period for
public comment (but within the time specified for judicial review) and
if such objection is of central relevance to the outcome of the rule.
Any person seeking to make such a demonstration should submit a
Petition for Reconsideration to the Office of the Administrator, U.S.
EPA, Room 3000, WJC South Building, 1200 Pennsylvania Ave. NW,
Washington, DC 20460, with a copy to both the person(s) listed in the
preceding FOR FURTHER INFORMATION CONTACT section, and the Associate
General Counsel for the Air and Radiation Law Office, Office of General
Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.

II. Background

A. What is the statutory authority for this action?

    The statutory authority for this action is provided by sections 112
and 301 of the CAA, as amended (42 U.S.C. 7401 et seq.). Section
112(d)(6) requires the EPA to review standards promulgated under CAA
section 112(d) and revise them ``as necessary (taking into account
developments in practices, processes, and control technologies)'' no
less often than every 8 years following promulgation of those
standards. This is referred to as a ``technology review'' and is
required for all standards established under CAA section 112(d)
including generally available control technology (GACT) standards that
apply to area sources.\1\ This action finalizes the 112(d)(6)
technology review for the Wood Preserving Area Sources area source
NESHAP.
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    \1\ For categories of area sources subject to GACT standards,
CAA sections 112(d)(5) and (f)(5) provide that the EPA is not
required to conduct a residual risk review under CAA section
112(f)(2).
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    Several additional CAA sections are relevant to this action as they
specifically address regulation of hazardous air pollutant (HAP)
emissions from area sources. Collectively, CAA sections 112(c)(3),
(d)(5), and (k)(3) are the basis of the Area Source Program under the
Urban Air Toxics Strategy, which provides the framework for regulation
of area sources under CAA section 112.
    Section 112(k)(3)(B) of the CAA requires the EPA to identify at
least 30 HAP that pose the greatest potential health threat in urban
areas with a primary goal of achieving a 75 percent reduction in cancer
incidence attributable to HAP emitted from stationary sources. As
discussed in the Integrated Urban Air Toxics Strategy (64 FR 38706,
38715, July 19, 1999), the EPA identified 30 HAP emitted from area
sources that pose the greatest potential health threat in urban areas,
and these HAP are commonly referred to as the ``30 urban HAP.''
    Section 112(c)(3), in turn, requires the EPA to list sufficient
categories or subcategories of area sources to ensure that area sources
representing 90 percent of the emissions of the 30 urban HAP are
subject to regulation. The EPA implemented these requirements through
the Integrated Urban Air Toxics Strategy by identifying and setting
standards for categories of area sources including the Wood Preserving
Area Sources source category that is addressed in this action.
    CAA section 112(d)(5) provides that for area source categories, in
lieu of setting maximum achievable control technology (MACT) standards
(which are generally required for major source categories), the EPA may
elect to promulgate standards or requirements for area sources ``which
provide for the use of generally available control technology or
management practices [GACT] by such sources to reduce emissions of
hazardous air pollutants.'' In developing such standards, the EPA
evaluates the control technologies and management practices that reduce
HAP emissions that are generally available for each area source
category. Consistent with the legislative history, we can consider
costs and economic impacts in determining what constitutes GACT.
    GACT standards were set for the Wood Preserving Area Sources source
category in 2007. As noted above, this action finalizes the required
CAA 112(d)(6) technology review for that source category.

B. What is the Wood Preserving Area Sources source category and how
does the NESHAP regulate HAP emissions from the source category?

    The EPA promulgated the Wood Preserving Area Sources NESHAP on July
16, 2007 (72 FR 38864). The standards are codified at 40 CFR part 63,
subpart QQQQQQ. The Wood Preserving Area Sources industry consists of
facilities that use either a pressurized or thermal treatment process
to impregnate wood with chemicals that provide long-term resistance to
attack by fungi, bacteria, insects, or marine borers. Some of the
products produced by the wood preserving industry include posts, cross
ties, switch ties, utility poles, round timber pilings, lumber for
aquatic applications, and fire-retardant lumber products.
    More than 95 percent of all treated wood is preserved through
pressurized processes. Almost all pressurized wood preservation
processes use a closed treating cylinder or retort. A retort is an
airtight pressure vessel, typically a long horizontal cylinder, used
for the pressure impregnation of wood products with a liquid
preservative. In a thermal treatment process, the wood is exposed to
the preservative in an open vessel. The wood is immersed between
separate tanks containing heated and cold preservative, which are
either oil-borne or waterborne. Alternatively, thermal treated wood may
be immersed in one tank that is first heated then allowed to cool.
During the hot bath, the expansion of air in the wood forces some air
out and improves the penetration of preservatives. In the cold bath,
air in the wood contracts, creating a partial

vacuum, and atmospheric pressure forces more preservative into the
wood.
    There are three general classes of wood preservatives: (a) oils,
such as creosote and petroleum solutions of pentachlorophenol (PCP) and
copper naphthenate, (b) waterborne salts that are applied as water
solutions, such as chromated copper arsenate (CCA), and (c) light
organic solvents, which serve as carriers for synthetic insecticides.
Over the past few decades, the wood preserving industry has undergone
several changes related to the types of preservatives used for certain
applications and the associated emissions. Of the variety of wood
preservatives being used today, some contain HAP while others do not.
    Per 40 CFR 63.11428, the NESHAP is applicable to any wood
preserving operation located at an area source that emits HAP. However,
the urban HAP for which the source category was listed are arsenic,
chromium, methylene chloride, and dioxins (72 FR 16652). As such, the
Wood Preserving Area Sources NESHAP only applies to operations with the
potential to emit these four urban HAP. Three wood preservatives, PCP,
CCA, and ammoniacal copper zinc arsenate (ACZA), contain at least one
of the urban HAP. The HAP PCP contains trace concentrations of dioxins,
which are an urban HAP. The urban HAP arsenic and chromium are
contained in CCA. The urban HAP arsenic is contained in ACZA. The EPA
is not aware of any facilities currently using a wood preservative
containing the urban HAP methylene chloride. No methylene chloride
emissions were reported in the 2019 Toxic Release Inventory (TRI) and
the EPA's Office of Chemical Safety and Pollution Prevention (OCSPP)
does not currently identify the use of methylene chloride as a wood
preservative. Altogether, the source category covered by the GACT
standards currently includes 322 facilities. The EPA estimates that 177
of the 322 Wood Preserving Area Sources use a wood preservative
containing an urban HAP and are therefore subject to the GACT
standards. The remaining area sources use wood preservatives that do
not contain HAP or use creosote, which contains the HAP naphthalene.
    The GACT standards require any facility using a pressure treatment
process to use a retort or similarly enclosed vessel for the
preservative treatment. Facilities using a thermal treatment process
are required to use process treatment tanks equipped with air
scavenging systems to capture and control air emissions. In addition,
all facilities must prepare and operate according to a management
practice plan to minimize air emissions, including emissions from
process tanks and equipment (e.g., retorts, other enclosed vessels,
thermal treatment tanks), storage, handling, and transfer operations.
These standards are required to be documented in a management practices
plan. See 40 CFR 63.11430(c).

C. What changes did we propose for the Wood Preserving Area Sources
source category in our March 7, 2022, proposal?

    On March 7, 2022, the EPA published a proposed rule in the Federal
Register for the Wood Preserving Area Source NESHAP, 40 CFR part 63,
subpart QQQQQQ, that took into consideration the TR analyses. In the
proposed rule, we proposed no changes to the standards as a result of
the TR. The EPA proposed minor editorial and formatting changes to
Table 1 in the Wood Preserving Area Sources NESHAP which outlines the
applicability of CAA General Provisions (see docket ID EPA-HQ-OAR-2021-
0133-0017 for Redline Version of 40 CFR part 63, subpart QQQQQQ Showing
Proposed Changes).

III. What is included in this final rule?

    This action finalizes the EPA's determinations pursuant to the TR
provisions of CAA section 112 for the Wood Preserving Area Sources
source category. This action also finalizes other changes to the
NESHAP, including minor editorial and formatting changes to Table 1 in
the Wood Preserving Area Sources NESHAP.

A. What are the final rule amendments based on the technology review
for the Wood Preserving Area Sources source category?

    We determined that there are no developments in practices,
processes, and control technologies that warrant revisions to the GACT
standards for this source category. Therefore, this final rule does not
make any revisions to the GACT standards under CAA section 112(d)(6).

B. What other changes are we finalizing in the NESHAP for Wood
Preserving Area Sources?

    This action also finalizes, as proposed, minor editorial and
formatting changes to the Wood Preserving Area Sources NESHAP Table 1,
which outlines the applicability of CAA General Provisions. The notice
of proposed rulemaking described the changes to the Subpart QQQQQQ
Table 1, and a redline strikeout version of the Subpart QQQQQQ Table 1
showing proposed changes was available in the docket (see docket ID
EPA-HQ-OAR-2021-0133-0017). This action finalizes the changes as
detailed in that document.

C. What are the technical corrections to the NESHAP for Surface Coating
of Wood Building Products?

    This action finalizes technical corrections to the NESHAP for
Surface Coating of Wood Building Products. As described in the March 7,
2022, proposal, changes are necessary because the NESHAP for Surface
Coating of Wood Building Products contains a reference to an
Occupational Safety and Health Administration (OSHA) provision that has
since been removed.

IV. What is the rationale for our final decisions and amendments for
the Wood Preserving Area Sources source category and the technical
corrections to the NESHAP for Surface Coating of Wood Building
Products?

    For each issue, this section provides a description of what we
proposed and what we are finalizing for the issue, the EPA's rationale
for the final decisions and amendments, and a summary of comments and
responses.

A. Technology Review for the Wood Preserving Area Sources Source
Category

1. What did we propose pursuant to CAA section 112(d)(6) for the Wood
Preserving Area Sources source category?
    Based on our TR described in the March 7, 2022, proposal (87 FR
12633), we found no developments in practices, processes, or control
technologies that necessitate revisions to the standards for the Wood
Preserving Area Sources NESHAP (40 CFR part 63, subpart QQQQQQ).
2. How did the TR change for the Wood Preserving Area Sources source
category?
    After considering the comments received on the proposed rule and
given that commenters did not identify any new practices, processes,
and control technologies to further reduce emissions of arsenic,
chromium, dioxins, or methylene chloride, the EPA has decided that no
changes to the TR are necessary. Therefore, the EPA is finalizing its
findings in the proposed rule that revisions to the emission standards
for the Wood Preserving Area Sources NESHAP are not warranted under CAA
section 112(d)(6).
3. What comments did we receive on the TR, and what are our responses?
    Two comments were received on the proposed rulemaking. To access
these

comments in the docket for the proposed rule, see Docket ID No. EPA-HQ-
OAR-2021-0133-0022 and EPA-HQ-OAR-2021-0133-0021.
    Comment: A commenter acknowledged that EPA regulations minimize
emissions of the urban HAP (arsenic, chromium, dioxins, and methylene
chloride) but expressed concern regarding the health impacts associated
with long-term exposure. The commenter stated that the EPA's
determination that there was no cost-effective measure to further
reduce emissions failed to consider the human health costs related to
the bioaccumulation of HAP in surrounding environments and the
secondary exposure to people beyond those directly affected at the
source. The commenter suggested that the EPA consider natural and
sustainable ways of preserving wood that do not incorporate synthetic
chemicals and referenced an article on the complex nanostructure of
cicada wings. The article, last updated in 2021, indicates that the
surface of cicada wings is comprised of microscopic ``nanopillars'' and
is naturally coated with waxy substances that repel water, dirt, and
bacteria. The author of the article writes that scientists are
currently exploring ways to design and manufacture nanoscale surfaces
that possess these properties.
    Response: The TR did not identify any generally available non-
synthetic methods of wood preserving, and the commenter did not provide
any direct information identifying an industrial-scale natural method
of treating wood that would produce long-term resistance to attack by
fungi, bacteria, insects, or marine borers for use as posts, cross
ties, switch ties, utility poles, round timber pilings, lumber for
aquatic applications, and fire-retardant wood products. The EPA did not
identify any natural wood preserving methods that imitate the
nanostructure of cicada wings and their ability to repel water, dirt,
and bacteria.
    Comment: A commenter opposed the proposal on the basis that there
should be stronger standards to protect populations of concern. The
commenter stated that although air quality would not be negatively
impacted by the proposed action, it would also not improve it for
populations of concern. The commenter restated results from our
demographic analysis and pointed out that people of lower socioeconomic
status and minorities are being exposed to emissions at a higher rate
than other populations. The commenter noted that if arsenic levels are
high enough, it can negatively impact the environment. The commenter
requested that the EPA reevaluate the proposed decision.
    Response: This action implements CAA section 112(d)(6), which
requires the EPA to review standards promulgated under CAA section
112(d) and revise them ``as necessary (taking into account developments
in practices, processes, and control technologies).'' The TR and
neither commenter identified any cost-effective developments in
practices, processes, and control technologies for wood preserving
facilities that would further reduce emissions beyond the management
practice and reporting requirements that currently exist in the rule.
As the commenter noted, the proposal would not negatively impact air
quality. The EPA notes that reducing emissions of urban air toxics has
been a priority for EPA since the passage of the Clean Air Act
Amendments in 1990. There have been significant reductions in urban air
toxics because of EPA regulations, including the Wood Preserving Area
Sources NESHAP, and enforcement actions. The EPA expects compliance
with the Wood Preserving Area Sources NESHAP has reduced and will
continue to reduce the effects of emissions on populations in proximity
to wood preserving facilities, including in communities potentially
overburdened by pollution. For more information on our analysis of
environmental justice, see Section VI.F.
4. What is the rationale for our final approach for the TR?
    Based on the TR and after evaluating all comments received on the
TR, we determined that no changes to the review are necessary.
Therefore, pursuant to CAA section 112(d)(6), we are finalizing the TR
as proposed.

B. Changes to Wood Preserving Area Sources NESHAP Table 1 to Subpart
QQQQQQ of Part 63--Applicability of General Provisions to Subpart
QQQQQQ

1. What changes did we propose to Table 1 to Subpart QQQQQQ of Part
63--Applicability of General Provisions to Subpart QQQQQQ?
    In the March 7, 2022, proposal (87 FR 12633), we proposed minor
editorial and formatting changes to Table 1 to Subpart QQQQQQ of Part
63 for the Wood Preserving Area Sources NESHAP listing the applicable
general provisions. The notice of proposed rulemaking described the
changes and a redline strikeout version of Table 1 showing proposed
changes was available in the docket.
2. How did revisions in the final action change Table 1 to Subpart
QQQQQQ of Part 63--Applicability of General Provisions to Subpart
QQQQQQ?
    In the final rule, the EPA is making the revisions to Table 1 to
Subpart QQQQQQ of Part 63 for the Wood Preserving Area Sources NESHAP
as described in the proposal published on March 7, 2022.
3. What comments did we receive on the proposed changes to Table 1 to
Subpart QQQQQQ of Part 63--Applicability of General Provisions to
Subpart QQQQQQ, and what are our responses?
    No comments were received on the proposed changes to Table 1 to
Subpart QQQQQQ of Part 63 for the Wood Preserving Area Sources source
category.
4. What is the rationale for our final approach for the changes to
Table 1 to Subpart QQQQQQ of Part 63--Applicability of General
Provisions to Subpart QQQQQQ?
    No comments were received regarding the proposed changes to Table 1
to Subpart QQQQQQ of Part 63 for the Wood Preserving Area Sources
source category. Therefore, those changes are being finalized as
proposed.

C. Technical Corrections to the NESHAP for Surface Coating of Wood
Building Products

1. What technical corrections were proposed to the NESHAP for Surface
Coating of Wood Building Products?
    In the March 7, 2022, proposal (87 FR 12633), we proposed technical
corrections to the NESHAP for Surface Coating of Wood Building
Products. The proposed technical corrections were necessary because the
NESHAP for Surface Coating of Wood Building Products contains a
reference to an OSHA provision that has changed. The EPA proposed to
amend 40 CFR 63.4741(a)(1)(i) and (a)(4), which describe how to
determine the mass fraction of organic HAP in each material used, to
remove references to OSHA-defined carcinogens as specified in 29 CFR
1910.1200(d)(4). The reference to OSHA-defined carcinogens as specified
in 29 CFR 1910.1200(d)(4) is intended to specify which compounds must
be included in calculating total organic HAP content of a coating
material if they are present at 0.1 percent or greater by mass. The EPA
is eliminating this reference because OSHA revised its hazard
communication standard in 2012 and completely removed 29 CFR
1910.1200(d)(4) from the CFR (58 FR

17574, March 26, 2012). Consequently, the NESHAP for Surface Coating of
Wood Building Products cross-references a regulatory citation that no
longer exists. The EPA proposed to replace these references to OSHA-
defined carcinogens and 29 CFR 1910.1200(d)(4) with a new table
explicitly included in the regulatory text (proposed as Table 7 to 40
CFR part 63, subpart QQQQ) of those organic HAP that must be included
in calculating the total organic HAP content of a coating material if
they are present at 0.1 percent or greater by mass. The proposed
redline strikeout regulatory edits that would be necessary to
incorporate the changes were included in the docket.
2. How did the technical corrections to the NESHAP for Surface Coating
of Wood Building Products change?
    The EPA is finalizing the technical corrections to the NESHAP for
Surface Coating of Wood Building Products as proposed.
3. What comments did we receive on the technical corrections to the
NESHAP for Surface Coating of Wood Building Products?
    No comments were received on the proposed technical corrections to
the NESHAP for Surface Coating of Wood Building Products.
4. What is the rationale for our final approach for the technical
corrections to the NESHAP for Surface Coating of Wood Building
Products?
    No comments were received on the proposed technical corrections to
the NESHAP for Surface Coating of Wood Building Products. Therefore,
the technical corrections to the NESHAP for Surface Coating of Wood
Building Products are being finalized as proposed.

V. Summary of Cost, Environmental, and Economic Impacts and Additional
Analyses Conducted

A. What are the affected facilities?

    Approximately 322 area source wood preserving facilities in the
United States are subject to 40 CFR part 63, subpart QQQQQQ.
Approximately 177 of those facilities use or are permitted to use a
wood preservative containing arsenic, chromium, dioxins, or methylene
chloride, and therefore must comply with the management practice
requirements.

B. What are the air quality impacts?

    Because we are not revising the standards for Wood Preserving Area
Sources, we do not anticipate any quantifiable air quality impacts as a
result of the final action.

C. What are the cost impacts?

    We expect that the action will have minimal cost impacts for Wood
Preserving Area Sources. In the March 7, 2022, proposed rule we
estimated a one-time cost of $270 per facility (in 2019 dollars)
associated with an affected facility reviewing the rule. Because the
EPA is finalizing the rule as proposed, there are no changes to this
cost estimate.

D. What are the economic impacts?

    Economic impact analyses focus on changes in market prices and
output levels. If changes in market prices and output levels in the
primary markets are significant enough, impacts on other markets may
also be examined. Both the magnitude of costs needed to comply with a
final rule and the distribution of these costs among affected
facilities can have a role in determining how the market will change in
response to a final rule. Because the costs associated with the final
revisions are minimal, no significant economic impacts are anticipated
as a result of the final amendments. As presented in the March 7, 2022,
proposed rule, the total cost associated with this action is estimated
to be approximately $87,000. This estimate is based on the one-time
cost of $270 per facility with 322 facilities estimated to be subject
to the regulation.

E. What are the benefits?

    The final amendments to the Wood Preserving Areas Sources NESHAP
are limited to editorial and technical corrections to Table 1 at the
end of the regulation listing the applicable part 63 General
Provisions. These changes improve the accuracy and clarity of the rule.

F. What analysis of environmental justice did we conduct?

    Executive Order 12898 directs the EPA to identify the populations
of concern who are most likely to experience unequal burdens from
environmental harms; specifically, minority populations (i.e., people
of color), low-income populations, and Indigenous peoples (59 FR 7629,
February 16, 1994). Additionally, Executive Order 13985 is intended to
advance racial equity and support underserved communities through
Federal government actions (86 FR 7009, January 20, 2021). The EPA
defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' The EPA further defines the term fair treatment to mean
that ``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.'' In recognizing that
people of color and low-income populations often bear an unequal burden
of environmental harms and risks, the EPA continues to consider ways of
protecting them from adverse public health and environmental effects of
air pollution.
    To examine the potential for any EJ issues that might be associated
with the source category, we performed a demographic analysis at
proposal, and have determined that the data and affected facilities did
not change as a result of public comments. Therefore, the analysis from
the proposed rule is still applicable for this final action. The
results of the demographic analysis can be found in section IV(F) of
the proposed rule's preamble (see 87 FR 12633, March 7, 2022). The
analysis included an assessment of individual demographic groups of the
populations living within 5 km and within 50 km of the facilities. We
then compared the data from the analysis to the national average for
each of the demographic groups. The results show that for populations
within 5 km of the 322 existing facilities, the following demographic
groups were above the national average: African American (21 percent
versus 12 percent nationally), Hispanic/Latino (21 percent versus 19
percent nationally), and people living below the poverty level (18
percent versus 13 percent nationally). The results show that for
populations within 50 km of the 322 existing facilities, the percent
African American population was above the national average (14 percent
versus 12 percent nationally). The methodology and the results of the
demographic analysis are presented in a technical report, ``Analysis of
Demographic Factors for Populations Living Near Wood Preserving Area
Sources,'' available in the docket for this action (Docket ID No. EPA-
HQ-OAR-2021-0133).
    Given that the EPA is not revising the standards for Wood
Preserving Area Sources, we do not anticipate any quantifiable air
quality impacts as a result of the final action. The final amendments
are limited to editorial and technical corrections to Table 1 at the
end of the regulation listing the

applicable part 63 General Provisions. These changes improve the
accuracy and clarity of the rule. We note that wood preservatives
containing the urban HAP arsenic, chromium, methylene chloride, and
dioxin (a trace contaminant in PCP) either have been significantly
reduced, are in the process of being phased out, or have been phased
out completely since this source category was listed (see Docket ID No.
EPA-HQ-OAR-2021-0133-0016 Technology Review for the Wood Preserving
Area Sources NESHAP, page 6, and Docket ID No. EPA-HQ-OPP-2014-0653
Pentachlorophenol Final Registration Review Decision).

G. What analysis of children's environmental health did we conduct?

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

VI. Statutory and Executive Order Reviews

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

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

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0598. This action does not include any new
reporting or recordkeeping requirements and therefore does not impose
an information collection burden.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. The
small entities subject to the requirements of this action are small
businesses. The Agency has determined that all small entities affected
by this action, estimated to be 173 entities, may experience an impact
of less than 0.7 percent of revenues, with approximately 91 percent of
these entities estimated to experience a potential impact of less than
0.1 percent of revenues. Details of the analysis were presented in the
spreadsheet titled RFA_Analysis_Wood_2022_Final.xlsx, which is found in
the docket.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. While this action
creates an enforceable duty on the private sector, the cost does not
exceed $100 million or more.

E. Executive Order 13132: Federalism

    This action does not have federalism implications in relation to
Executive Order 13132. It will not have substantial direct effects on
the states, on the relationship between the National Government and the
states, or on the distribution of power and responsibilities among the
various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. None of the Wood Preserving Area Sources that
have been identified as being affected by this action are owned or
operated by tribal governments. However, we determined that 145 tribes
were located near a Wood Preserving Area Source facility. Consistent
with the EPA Policy on Coordination and Consultation with Indian
Tribes, the EPA offered tribal leadership the opportunity for
government-to-government consultation with no response.

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

    This action is not subject to Executive Order 13045 because the EPA
does not believe the environmental health risks or safety risks
addressed by this action present a disproportionate risk to children.

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards.

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

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or Indigenous
peoples) and low-income populations.
    The demographic analysis presented in Section V.F. of this preamble
provides information on the demographic characteristics (e.g., race,
ethnicity, income) of the populations living near wood preserving
facilities but does not provide information on health or environmental
effects from these sources. From the demographic analysis, EPA
determined that for populations living within 5 km of wood preserving
facilities the percentage of residents who are African American,
Hispanic/Latino, or living below the poverty level are higher than the
nationwide average (see section IV.F. of 87 FR 12633, March 7, 2022).
    Because percentages of people of color and low-income individuals
living near wood preserving facilities are higher than nationwide
averages, the EPA acknowledges that the human health or environmental
conditions that exist prior to this action have the potential to result
in disproportionate and adverse human health or environmental effects
on people of color, low-income populations, and/or Indigenous peoples.
However, we note that wood preservatives containing the urban HAP
arsenic, chromium, methylene chloride, and dioxin (a trace contaminant
in PCP) either have been significantly reduced, are in the process of
being phased out, or have been phased out completely since this source
category was listed. This action is not likely to change any potential
existing disproportionate effects on people of color, low-income
populations and/or Indigenous peoples because we are not amending
existing emission standards in the Wood Preserving Area Sources NESHAP
and are finalizing minor editorial and formatting changes as discussed
earlier in this preamble.

    The information supporting this Executive Order review is contained
in a technical report, Analysis of Demographic Factors for Populations
Living Near National Emission Standard for Hazardous Air Pollutants:
Technology Review for Wood Preserving Area Sources (see Docket ID No.
EPA-HQ-OAR-2021-0133-0020) and is discussed in section V.F of this
final rule.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report for this action to each House of the Congress and to the
Comptroller General of the United States. Neither of the NESHAP amended
by this action constitute a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedures,
Air pollution control, Hazardous substances, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements.

Michael S. Regan,
Administrator.

    For the reasons set out in the preamble, title 40, chapter I, part
63 of the Code of Federal Regulations is amended as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart QQQQ--[Amended]

0
2. Section 63.4741 is amended by revising paragraphs (a)(1)(i) and
(a)(4) to read as follows:

Sec.  63.4741  How do I demonstrate initial compliance with the
emission limitations?

* * * * *
    (a) * * *
    (1) * * *
    (i) Count each organic HAP in Table 7 to Subpart QQQQ of Part 63
that is measured to be present at 0.1 percent by mass or more and at
1.0 percent by mass or more for other compounds. For example, if
toluene (not listed in Table 7 to this subpart) is measured to be 0.5
percent of the material by mass, you do not have to count it. Express
the mass fraction of each organic HAP you count as a value truncated to
four places after the decimal point (e.g., 0.3791).
* * * * *
    (4) Information from the supplier or manufacturer of the material.
You may rely on information other than that generated by the test
methods specified in paragraphs (a)(1) through (3) of this section,
such as manufacturer's formulation data, if it represents each organic
HAP in Table 7 to this subpart that is present at 0.1 percent by mass
or more and at 1.0 percent by mass or more for other compounds. For
example, if toluene (not listed in Table 7 to this subpart) is 0.5
percent of the material by mass, you do not have to count it. For
reactive adhesives in which some of the HAP react to form solids and
are not emitted to the atmosphere, you may rely on manufacturer's data
that expressly states the organic HAP or volatile matter mass fraction
emitted. If there is a disagreement between such information and
results of a test conducted according to paragraphs (a)(1) through (3)
of this section, then the test method results will take precedence
unless, after consultation, you demonstrate to the satisfaction of the
enforcement agency the formulation data are correct.
* * * * *

0
3. Table 7 to subpart QQQQ of part 63 is added to read as follows:

  Table 7 to Subpart QQQQ of Part 63--List of HAP That Must Be Counted
  Toward Organic HAP Content if Present at 0.1 Percent or More by Mass
------------------------------------------------------------------------
                      Chemical name                           CAS No.
------------------------------------------------------------------------
1,1,2,2-Tetrachloroethane...............................         79-34-5
1,1,2-Trichloroethane...................................         79-00-5
1,1-Dimethylhydrazine...................................         57-14-7
1,2-Dibromo-3-chloropropane.............................         96-12-8
1,2-Diphenylhydrazine...................................        122-66-7
1,3-Butadiene...........................................        106-99-0
1,3-Dichloropropene.....................................        542-75-6
1,4-Dioxane 123-91-1....................................
2,4,6-Trichlorophenol...................................         88-06-2
2,4/2,6-Dinitrotoluene (mixture)........................      25321-14-6
2,4-Dinitrotoluene......................................        121-14-2
2,4-Toluene diamine.....................................         95-80-7
2-Nitropropane..........................................         79-46-9
3,3'-Dichlorobenzidine..................................         91-94-1
3,3'-Dimethoxybenzidine.................................        119-90-4
3,3'-Dimethylbenzidine..................................        119-93-7
4,4'-Methylene bis(2-chloroaniline).....................        101-14-4
Acetaldehyde............................................         75-07-0
Acrylamide..............................................         79-06-1
Acrylonitrile...........................................        107-13-1
Allyl chloride..........................................        107-05-1
alpha-Hexachlorocyclohexane (a-HCH).....................        319-84-6
Aniline.................................................         62-53-3
Benzene.................................................         71-43-2
Benzidine...............................................         92-87-5
Benzotrichloride........................................         98-07-7
Benzyl chloride.........................................        100-44-7
beta-Hexachlorocyclohexane (b-HCH)......................        319-85-7
Bis(2-ethylhexyl)phthalate..............................        117-81-7
Bis(chloromethyl)ether..................................        542-88-1
Bromoform...............................................         75-25-2

Captan..................................................        133-06-2
Carbon tetrachloride....................................         56-23-5
Chlordane...............................................         57-74-9
Chlorobenzilate.........................................        510-15-6
Chloroform..............................................         67-66-3
Chloroprene.............................................        126-99-8
Cresols (mixed).........................................       1319-77-3
DDE.....................................................       3547-04-4
Dichloroethyl ether.....................................        111-44-4
Dichlorvos..............................................         62-73-7
Epichlorohydrin.........................................        106-89-8
Ethyl acrylate..........................................        140-88-5
Ethylene dibromide......................................        106-93-4
Ethylene dichloride.....................................        107-06-2
Ethylene oxide..........................................         75-21-8
Ethylene thiourea.......................................         96-45-7
Ethylidene dichloride (1,1-Dichloroethane)..............         75-34-3
Formaldehyde............................................         50-00-0
Heptachlor..............................................         76-44-8
Hexachlorobenzene.......................................        118-74-1
Hexachlorobutadiene.....................................         87-68-3
Hexachloroethane........................................         67-72-1
Hydrazine...............................................        302-01-2
Isophorone..............................................         78-59-1
Lindane (hexachlorocyclohexane, all isomers)............         58-89-9
m-Cresol................................................        108-39-4
Methylene chloride......................................         75-09-2
Naphthalene.............................................         91-20-3
Nitrobenzene............................................         98-95-3
Nitrosodimethylamine....................................         62-75-9
o-Cresol................................................         95-48-7
o-Toluidine.............................................         95-53-4
Parathion...............................................         56-38-2
p-Cresol................................................        106-44-5
p-Dichlorobenzene.......................................        106-46-7
Pentachloronitrobenzene.................................         82-68-8
Pentachlorophenol.......................................         87-86-5
Propoxur................................................        114-26-1
Propylene dichloride....................................         78-87-5
Propylene oxide.........................................         75-56-9
Quinoline...............................................         91-22-5
Tetrachloroethene.......................................        127-18-4
Toxaphene...............................................       8001-35-2
Trichloroethylene.......................................         79-01-6
Trifluralin.............................................       1582-09-8
Vinyl bromide...........................................        593-60-2
Vinyl chloride..........................................         75-01-4
Vinylidene chloride.....................................         75-35-4
------------------------------------------------------------------------

Subpart QQQQQQ--[Amended]

0
4. Table 1 to subpart QQQQQQ of part 63 is revised to read as follows:

Table 1 to Subpart QQQQQQ of Part 63--Applicability of General
Provisions to Subpart QQQQQQ

    As required in Sec.  63.11432, you must comply with the
requirements of the NESHAP General Provisions (40 CFR part 63, subpart
A) as shown in the following table.

----------------------------------------------------------------------------------------------------------------
                                                                 Applies to  subpart
             Citation                       Subject                    QQQQQQ?                 Explanation
----------------------------------------------------------------------------------------------------------------
63.1(a)(1)-(4)....................  General applicability    Yes.......................
                                     of the General
                                     Provisions.
63.1(a)(5)........................  Reserved...............  No........................
63.1(a)(6)........................  General applicability    Yes.......................
                                     of the General
                                     Provisions.
63.1(a)(7)-(9)....................  Reserved...............  No........................
63.1(a)(10)-(12)..................  General applicability    Yes.......................
                                     of the General
                                     Provisions.
63.1(b)(1)........................  Initial applicability    Yes.......................
                                     determination.
63.1(b)(2)........................  Reserved...............  No........................
63.1(b)(3)........................  Record of applicability  Yes.......................
                                     determination.

63.1(c)(1)-(2)....................  Applicability of         Yes.......................
                                     subpart A of this part
                                     after a relevant
                                     standard has been set.
63.1(c)(3)-(4)....................  Reserved...............  No........................
63.1(c)(5)........................  Notification             Yes.......................
                                     requirements for an
                                     area source that
                                     increases HAP
                                     emissions to major
                                     source levels.
63.1(c)(6)........................  Reclassification.......  Yes.......................
63.1(d)...........................  Reserved...............  No........................
63.1(e)...........................  Applicability of permit  Yes.......................
                                     program before a
                                     relevant standard has
                                     been set.
63.2..............................  Definitions............  Yes.......................
63.3..............................  Units and abbreviations  Yes.......................
63.4..............................  Prohibited activities    Yes.......................
                                     and circumvention.
63.5(a)(1)........................  Applicability of         No........................
                                     preconstruction review
                                     requirements.
63.5(a)(2)........................  Applicability of         Yes.......................
                                     notification
                                     requirements.
63.5(b)(1)........................  Requirements for newly   Yes.......................
                                     constructed and
                                     reconstructed sources.
63.5(b)(2)........................  Reserved...............  No........................
63.5(b)(3)........................  Required                 No........................  Subpart QQQQQQ does not
                                     preconstruction                                      regulate major
                                     approval required for                                sources.
                                     major source
                                     construction and
                                     reconstruction.
63.5(b)(4)........................  Notification             Yes.......................
                                     requirements for
                                     construction or
                                     reconstruction of area
                                     sources.
63.5(b)(5)........................  Reserved...............  No........................
63.5(b)(6)........................  Added equipment (or a    Yes.......................
                                     process change) must
                                     be considered part of
                                     the affected source
                                     and subject to all
                                     provisions in the
                                     relevant standards.
63.5(c)...........................  Reserved...............  No........................
63.5(d)...........................  Application for          No........................  Subpart QQQQQQ does not
                                     approval of                                          require an application
                                     construction or                                      for construction or
                                     reconstruction.                                      reconstruction.
63.5(e)...........................  Approval of              No........................  Subpart QQQQQQ does not
                                     construction or                                      require application
                                     reconstruction.                                      approval before
                                                                                construction or
                                                                                reconstruction.
63.5(f)...........................  Approval of              No........................  Subpart QQQQQQ does not
                                     construction or                                      require approval of
                                     reconstruction based                                 construction or
                                     on prior State                                       reconstruction based
                                     preconstruction review.                              on prior State
                                                                                preconstruction
                                                                                review.
63.6(a)...........................  Compliance with          Yes.......................
                                     standards and
                                     maintenance
                                     requirements.
63.6(b)(1)-(5)....................  Compliance dates for     Yes.......................
                                     new and reconstructed
                                     sources.
63(b)(6)..........................  Reserved...............  No........................
63(b)(7)..........................  Compliance dates for     Yes.......................
                                     new and reconstructed
                                     sources.
63.6(c)(1)-(2)....................  Compliance dates for     Yes.......................
                                     existing sources.
63.6(c)(3)-(4)....................  Reserved...............  No........................
63.6(c)(5)........................  Compliance dates for     Yes.......................
                                     existing sources.
63.6(d)...........................  Reserved...............  No
63.6(e)(1)........................  Operation and            Yes.......................
                                     maintenance
                                     requirements.
63.6(e)(2)........................  Reserved...............  No........................
63.6(e)(3)(i).....................  Startup, shutdown, and   No........................  Subpart QQQQQQ does not
                                     malfunction plan.                                    require a startup,
                                                                                shutdown, and
                                                                                malfunction plan.
63.6(e)(3)(ii)....................  Reserved...............  No........................
63.6(e)(3)(iii)-(ix)..............  Startup, shutdown, and   No........................  Subpart QQQQQQ does not
                                     malfunction plan.                                    require a startup,
                                                                                shutdown, and
                                                                                malfunction plan.
63.6(f)...........................  Compliance with          No........................  Subpart QQQQQQ does not
                                     nonopacity emission                                  contain emission or
                                     standards.                                           opacity limits.
63.6(g)...........................  Use of an alternative    No........................  Subpart QQQQQQ does not
                                     nonopacity emission                                  contain emission or
                                     standard.                                            opacity limits.
63.6(h)(1)........................  Compliance with opacity  No........................  Subpart QQQQQQ does not
                                     and visible emissions                                contain emission or
                                     standards.                                           opacity limits.
63.6(h)(2)(i).....................  Compliance with opacity  No........................  Subpart QQQQQQ does not
                                     and visible emissions                                contain emission or
                                     standards.                                           opacity limits.
63.6(h)(2)(ii)....................  Reserved...............  No........................
63.6(h)(2)(iii)...................  Compliance with opacity  No........................  Subpart QQQQQQ does not
                                     and visible emissions                                contain emission or
                                     standards.                                           opacity limits.
63.6(h)(3)........................  Reserved...............  No........................
63.6(h)(4)........................  Notification of opacity  No........................  Subpart QQQQQQ does not
                                     or visible emission                                  contain emission or
                                     observations.                                        opacity limits.
63.6 (h)(5)(i)-(iii)..............  Conduct of opacity or    No........................  Subpart QQQQQQ does not
                                     visible emission                                     contain emission or
                                     observations.                                        opacity limits.
63.6(h)(5)(iv)....................  Reserved...............  No........................
63.6(h)(5)(v).....................  Conduct of opacity or    No........................  Subpart QQQQQQ does not
                                     visible emission                                     contain emission or
                                     observations.                                        opacity limits.

63.6(h)(6)-(9)....................  Availability of records  No........................  Subpart QQQQQQ does not
                                     and use of continuous                                contain emission or
                                     opacity monitoring                                   opacity limits.
                                     system.
63.6(i)...........................  Extension of compliance  Yes.......................
                                     with emissions
                                     standards.
63.6(j)...........................  Exemption from           Yes.......................
                                     compliance with
                                     emissions standards.
63.7..............................  Performance Testing      No........................  Subpart QQQQQQ does not
                                     Requirements.                                        require performance
                                                                                tests.
63.8(a)(1)-(2)....................  Applicability of         No........................  Subpart QQQQQQ does not
                                     monitoring                                           require monitoring of
                                     requirements.                                        emissions.
63.8(a)(3)........................  Reserved...............  No........................
63.8(a)(4)........................  Applicability of         No........................  Subpart QQQQQQ does not
                                     monitoring                                           require monitoring of
                                     requirements.                                        emissions.
63.8(b)-(g).......................  Conduct of monitoring..  No........................  Subpart QQQQQQ does not
                                                                                require monitoring of
                                                                                emissions.
63.9(a)...........................  Applicability and        Yes.......................
                                     general information
                                     for notification
                                     requirements.
63.9(b)(1)-(2)....................  Initial notifications..  Yes.......................
63.9(b)(3)........................  Reserved...............  No........................
63.9(b)(4)-(5)....................  Initial notifications..  Yes.......................
63.9(c)-(d).......................  Extension of compliance  Yes.......................
                                     and special compliance
                                     requirements.
63.9(e), (f), (g).................  Notification of          No........................  Subpart QQQQQQ does not
                                     performance test,                                    require monitoring of
                                     opacity and visible                                  emissions.
                                     emission observation,
                                     and requirements for
                                     sources with
                                     continuous monitoring
                                     systems.
63.9(h)(1)-(3)....................  Notification of          Yes.......................
                                     compliance status.
63.9(h)(4)........................  Reserved...............  No........................
63.9(h)(5)-(6)....................  Notification of          Yes.......................
                                     compliance status.
63.9(i)-(j).......................  Adjustment to time       Yes.......................
                                     periods or postmark
                                     deadlines for
                                     submittal and review
                                     of required
                                     communications, and
                                     change in information
                                     already provided.
63.9(k)...........................  Electronic submission    No........................  Subpart QQQQQQ does not
                                     of notifications and                                 require electronic
                                     reports.                                             reporting.
63.10(a)-(b)......................  Recordkeeping and        No........................  Subpart QQQQQQ
                                     reporting requirement                                establishes
                                     applicability and                                    requirements for a
                                     general information.                                 report of deviations
                                                                                within 30 days.
63.10(c)(1).......................  Additional               No........................  Subpart QQQQQQ does not
                                     recordkeeping                                        require the use of
                                     requirements for                                     continuous monitoring
                                     sources with                                         systems.
                                     continuous monitoring
                                     systems.
63.10(c)(2)-(4)...................  Reserved...............  No........................
63.10(c)(5)-(8)...................  Additional               No........................  Subpart QQQQQQ does not
                                     recordkeeping                                        require the use of
                                     requirements for                                     continuous monitoring
                                     sources with                                         systems.
                                     continuous monitoring
                                     systems.
63.10(c)(9).......................  Reserved...............  No........................
63.10(c)(10)-(15).................  Additional               No........................  Subpart QQQQQQ does not
                                     recordkeeping                                        require the use of
                                     requirements for                                     continuous monitoring
                                     sources with                                         systems.
                                     continuous monitoring
                                     systems.
63.10(d)-(f)......................  General reporting        No........................  Subpart QQQQQQ
                                     requirements,                                        establishes
                                     additional                                           requirements for a
                                     requirements for                                     report of deviations
                                     sources with                                         within 30 days.
                                     continuous monitoring
                                     systems, and waiver of
                                     recordkeeping or
                                     reporting requirements.
63.11.............................  Control device           No........................  Subpart QQQQQQ does not
                                     requirements for                                     require flares and
                                     flares and work                                      does not require
                                     practice requirements                                monitoring for leaks.
                                     for monitoring leaks.
63.12.............................  State authorities and    Yes.......................
                                     delegations.
63.13.............................  Addresses of state air   Yes.......................
                                     pollution control
                                     agencies and EPA
                                     Regional Offices.
63.14.............................  Incorporations by        Yes.......................
                                     Reference.
63.15.............................  Availability of          Yes.......................
                                     information and
                                     confidentiality.
63.16.............................  Requirements for         Yes.......................
                                     Performance Track
                                     member facilities.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2023-04376 Filed 3-7-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
[Notices]
[Pages 26706-26707]
[FR Doc No: 2020-09503]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4515-DR; Docket ID FEMA-2020-0001]

Indiana; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Indiana (FEMA-4515-DR), dated April 3, 2020,
and related determinations.

DATES: The declaration was issued April 3, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 3, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
Indiana resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Indiana.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any

Federal funds provided under the Stafford Act for Public Assistance
will be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, James K. Joseph, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Indiana have been designated as
adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of Indiana.

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

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-09503 Filed 5-4-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44879-44881]
[FR Doc No: 2016-16362]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1267]

Compounded Drug Products That Are Essentially Copies of Approved
Drug Products Under Section 503B of the Federal Food, Drug, and
Cosmetic Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Compounded
Drug Products That Are Essentially Copies of Approved Drug Products
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' For a
drug product compounded by an outsourcing facility to qualify for the
exemptions under section 503B of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), it must not be essentially a copy of one or more
approved drug products and must meet the other conditions in section
503B. This guidance sets forth FDA's policies concerning the
``essentially a copy'' provision of section 503B.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work to finalize the guidance, submit
either electronic or written comments on this draft guidance by October
11, 2016. Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 by August 10, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1267 for ``Compounded Drug Products That Are Essentially
Copies of Approved Drug Products Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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.
    Submit comments on information collection issues to the Office of
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title, ``Compounded Drug Products That Are Essentially Copies of
Approved Drug Products Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.''
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Compounded Drug Products That Are Essentially Copies of
Approved Drug Products Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' In 2013, the Drug Quality and Security Act, created
a new section 503B of the Act, which describes a new category of

compounders called ``outsourcing facilities.'' Section 503B of the FD&C
Act describes the conditions that must be satisfied for human drug
products compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility to qualify for exemptions from
the following three sections of the FD&C Act:
     Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning
labeling of drugs with adequate directions for use);
     Section 505 (21 U.S.C. 355) (concerning the approval of
drugs under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)); and
     Section 582 (21 U.S.C. 360eee-1) (concerning drug supply
chain security requirements).
    One of the conditions that must be met for a compounded drug
product to qualify for the exemptions under section 503B of the Act is
that ``the drug is not essentially a copy of one or more approved
drugs'' (section 503B(a)(5)).
    Section 503B(d)(2) defines ``essentially a copy of an approved
drug'' as:
     A drug that is identical or nearly identical to an
approved drug, or a marketed drug not subject to section 503(b) and not
subject to approval in an application submitted under section 505,
unless, in the case of an approved drug, the drug appears on the drug
shortage list in effect under section 506E at the time of compounding,
distribution, and dispensing (section 503B(d)(2)(A)); or
     A drug, a component of which is a bulk drug substance that
is a component of an approved drug or a marketed drug that is not
subject to section 503(b) and not subject to approval in an application
submitted under section 505, unless there is a change that produces for
an individual patient a clinical difference, as determined by the
prescribing practitioner, between the compounded drug and the
comparable approved drug (section 503B(d)(2)(B)).
    This guidance sets forth FDA's policies concerning the
``essentially a copy'' provision of section 503B of the FD&C Act.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
``essentially a copy'' provision of section 503B of the FD&C Act. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (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 of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Under the draft guidance, pursuant to section 503B(d)(2)(B) of the
FD&C Act, if an outsourcing facility compounds a drug, the component of
which is a bulk drug substance that is a component of an approved drug,
there must be a change that produces a clinical difference for an
individual patient as determined by the prescribing practitioner. If an
outsourcing facility intends to rely on such a determination to
establish that a compounded drug is not essentially a copy of an
approved drug, the outsourcing facility should ensure that the
determination is documented on the prescription or order (which may be
a patient-specific prescription or a non-patient specific order) for
the compounded drug.
    If a prescription or order does not make clear that the
determination required by section 503B(d)(2)(B) has been made, the
outsourcing facility may contact the prescriber or healthcare facility,
and if the prescriber or healthcare facility confirms it, make a
notation on the prescription or order that the prescriber has
determined that the compounded product contains a change that produces
a clinical difference for patient(s). The date of the conversation with
the healthcare facility or prescriber should be included on the
prescription or order.
    We estimate that annually a total of approximately 40 outsourcing
facilities (``number of respondents'' in table 1, line 1) will consult
a prescriber to determine whether he or she has made a determination
that the compounded drug has a change that produces a clinical
difference for an individual patient as compared to the comparable
approved drug and that outsourcing facilities will document this
determination on approximately 4,000 prescriptions or orders for
compounded drugs (``total annual disclosures'' in table 1, line 1). We
estimate that the consultation between the outsourcing facility and the
prescriber or health care facility and adding a notation to each
prescription or order that does not already document this determination
will take approximately 3 minutes per prescription or order.
    In addition, if the outsourcing facility compounded a drug that is
identical or nearly identical to an approved drug product that appeared
on FDA's drug shortage list, the outsourcing facility should maintain
documentation (e.g., a notation on the order for the compounded drug)
regarding the status of the drug on FDA's drug shortage list at the
time of compounding, distribution and dispensing. We estimate that a
total of approximately 30 outsourcing facilities (``number of
respondents'' in table 1, line 2) will document this information on
approximately 3,000 prescriptions or orders for compounded drugs
(``total annual disclosures'' in table 1, line 2). We estimate that
checking FDA's drug shortage list and documenting this information will
take approximately 2 minutes per prescription or order.
    An outsourcing facility should also maintain records of
prescriptions or orders including notations that a prescriber has
determined that the compounded drug has a change that produces a
clinical difference for an individual patient. Because the time,
effort, and financial resources necessary to comply with this
collection of information would be incurred by licensed pharmacists and
licensed physicians in the normal course of their activities, it is
excluded from the definition of ``burden'' under 5 CFR 1320.3(b)(2).

    FDA estimates the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
      Type of reporting          Number of      disclosures    Total annual   Average burden per    Total hours
                                respondents   per respondent    disclosures       disclosure
----------------------------------------------------------------------------------------------------------------
Consultation between the                  40             100           4,000  3 minutes.........             200
 outsourcing facility and
 prescriber or health care
 facility, and the notation
 on the prescription or
 order documenting the
 prescriber's determination
 of clinical difference.
Checking FDA's drug shortage              30             100           3,000  2 minutes.........             100
 list and documenting on the
 prescription that the drug
 is in shortage.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16362 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P