[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61220-61221]
[FR Doc No: 2016-21227]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2526]

Determination That AQUAMEPHYTON (Phytonadione) Injectable and
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.

--------------------------------------------------------------------------------------------------------------------------------------------------------
          Application No.                   Drug name         Active  ingredient(s)       Strength(s)         Dosage form/route          Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 012223.........................  AQUAMEPHYTON..........  Phytonadione..........  10 milligram (mg)/     Injectable; Injection  Teligent Pharma Inc.
                                                                                milliliter (mL); 1
                                                                                mg/0.5 mL.
NDA 016087.........................  VALIUM................  Diazepam..............  5 mg/mL..............  Injectable; Injection  Roche.
NDA 017090.........................  TOFRANIL-PM...........  Imipramine Pamoate....  Equivalent to (EQ) 75  Capsule; Oral........  Mallinckrodt
                                                                                mg HCl; EQ 100 mg                             Pharmaceuticals.
                                                                                HCl; EQ 125 mg HCl;
                                                                                EQ 150 mg HCl.
NDA 017558.........................  ROBINUL...............  Glycopyrrolate........  0.2 mg/mL............  Injectable; Injection  Eurohealth
                                                                                International Sarl.
NDA 017911.........................  CLINORIL..............  Sulindac..............  200 mg...............  Tablet; Oral.........  Merck.
NDA 017962.........................  PARLODEL..............  Bromocriptine Mesylate  EQ 5 mg base.........  Capsule; Oral........  US Pharmaceuticals
                                                                                Holdings I LLC.
NDA 018579.........................  FUROSEMIDE............  Furosemide............  10 mg/mL.............  Injectable; Injection  Luitpold
                                                                                Pharmaceuticals,
                                                                                Inc.
NDA 018687.........................  NORMODYNE.............  Labetalol               100 mg; 200 mg; 300    Tablet; Oral.........  Schering-Plough Corp.
                                                              Hydrochloride.          mg; 400 mg.
NDA 018731.........................  BUSPAR................  Buspirone               5 mg.................  Tablet; Oral.........  Bristol-Myers Squibb.
                                                              Hydrochloride.
NDA 018776.........................  NORCURON..............  Vecuronium Bromide....  10 mg/vial; 20 mg/     Injectable; for        Organon USA Inc.
                                                                                vial.                  Injection.
NDA 019773.........................  VENTOLIN..............  Albuterol Sulfate.....  EQ 0.083% base.......  Solution; Inhalation.  GlaxoSmithKline.
NDA 019810.........................  PRILOSEC..............  Omeprazole............  10 mg; 20 mg; 40 mg..  Capsule, Delayed-      AstraZeneca
                                                                                Release Pellets;       Pharmaceuticals LP.
                                                                                Oral.
NDA 020059.........................  ADENOSCAN.............  Adenosine.............  60 mg/20 mL (3 mg/     Solution; I.V.         Astellas Pharma US,
                                                                                mL); 90 mg/30 mL (3    Infusion.              Inc.
                                                                                mg/mL).
NDA 020799.........................  FLOXIN OTIC...........  Ofloxacin.............  0.3%.................  Solution/Drops; Otic.  Daiichi-Sankyo.
NDA 021045.........................  PLAN B................  Levonorgestrel........  0.75 mg..............  Tablet; Oral.........  Teva Branded Pharm.
NDA 021214.........................  RESCULA...............  Unoprostone Isopropyl.  0.15%................  Solution/Drops;        Sucampo
                                                                                Ophthalmic.            Pharmaceuticals,
                                                                                Inc.
NDA 050459.........................  AMOXIL................  Amoxicillin...........  250 mg; 500 mg.......  Capsule; Oral........  GlaxoSmithKline.

NDA 050460.........................  AMOXIL................  Amoxicillin...........  125 mg/5mL; 50 mg/mL;  for Suspension; Oral.  GlaxoSmithKline.
                                                                                250 mg/5 mL.
NDA 050460.........................  LAROTID...............  Amoxicillin...........  50 mg/mL.............  for Suspension; Oral.  GlaxoSmithKline.
ANDA 072652........................  ALBUTEROL SULFATE.....  Albuterol Sulfate.....  EQ 0.083% base.......  Solution; Inhalation.  Mylan Specialty L.P.
ANDA 075117........................  ORAPRED...............  Prednisolone Sodium     EQ 15 mg base/5 mL...  Solution; Oral.......  Concordia
                                                              Phosphate.                                                            Pharmaceuticals Inc.
ANDA 075385........................  BUSPIRONE               Buspirone               5 mg; 10 mg; 15 mg...  Tablet; Oral.........  Teva Pharmaceuticals
                                      HYDROCHLORIDE.          Hydrochloride.                                                        USA, Inc.
ANDA 078665........................  LEVONORGESTREL........  Levonorgestrel........  0.75 mg..............  Tablet; Oral.........  Watson Labs.
ANDA 087811........................  PHRENILIN.............  Acetaminophen;          325 mg; 50 mg........  Tablet; Oral.........  Valeant
                                                              Butalbital.                                                           Pharmaceuticals
                                                                                International Inc.
ANDA 088825........................  BUTALBITAL,             Acetaminophen;          325 mg; 50 mg; 40 mg.  Capsule; Oral........  Gilbert Labs.
                                      ACETAMINOPHEN AND       Butalbital; Caffeine.
                                      CAFFEINE.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: August 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21227 Filed 9-2-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Rules and Regulations]
[Pages 31470-31481]
[FR Doc No: 2015-13500]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2004-0505; FRL-9928-25-OAR]
RIN 2060-AS42

Completion of Requirement To Promulgate Emissions Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: In this action the Environmental Protection Agency (EPA)
finalizes its proposed determination that the EPA completed its
statutory obligation under the Clean Air Act (CAA) to promulgate
emissions standards for source categories accounting for not less than
90 percent of the aggregated emissions of each of seven specific
hazardous air pollutants (HAP) enumerated in the CAA. On December 16,
2014, the EPA published the proposed determination that stated the
basis for the agency's conclusion that it completed this obligation in
February of 2011 by identifying the promulgated standards that
collectively satisfy this obligation and provided the public an
opportunity to comment on the EPA's determination. This action
finalizes the EPA's determination.

DATES: This action is effective on June 3, 2015.

ADDRESSES: The EPA has established a docket for this rulemaking under
Docket ID Number EPA-HQ-OAR-2004-0505. All documents in the docket are
listed in the http://www.regulations.gov index. Although listed in the
index, some information is not publicly available, e.g., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
http://www.regulations.gov or in hard copy at the EPA Docket Center,
EPA WJC West Building, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the EPA Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For questions about this action,
contact Mr. Nathan Topham, Office of Air Quality Planning and
Standards; Sector Policies and Programs Division, Metals and Inorganic
Chemicals Group (D243-02); Environmental Protection Agency; Research
Triangle Park, NC 27111; telephone number:<PHONE_NUMBER>; fax number:
(919) 541-3207; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Organization of this document. The information presented in this
preamble is organized as follows:

I. General Information
    A. Where can I get a copy of this document?
    B. Judicial Review
II. Background Information
III. How has the EPA satisfied its obligation under CAA section
112(c)(6)?
    A. What are the emissions standards that the EPA has promulgated
to meet the 90 percent requirement under CAA section 112(c)(6)?
    B. What are the surrogate pollutants used by the EPA when
establishing CAA section 112(d)(2) standards for the source
categories identified in the proposed determination?
IV. Summary of Significant Comments and Responses
    A. General/Legal Opposition to the EPA's Surrogacy
Determinations
V. Statutory and Executive Order Reviews
    A. Executive Order 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
    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. Where can I get a copy of this document?

    In addition to being available in the docket, an electronic copy of
this final action will also be available on the Internet through the
EPA's Technology Transfer Network (TTN) Web site, a forum for
information and technology exchange in various areas of air pollution
control. Following signature by the EPA Administrator, the EPA will
post a copy of this final action at: http://www.epa.gov/ttn/atw/eparules.html. Following publication in the Federal Register, the EPA
will post the Federal Register version of the rule at this same Web
site.

B. Judicial Review

    Under 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 by August 3,
2015. 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 ``[o]nly 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 us to convene a proceeding for reconsideration, ``[i]f the person
raising an objection can demonstrate to the EPA 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 to us should
submit a Petition for Reconsideration to the Office of the
Administrator, U.S. EPA, Room 3000, EPA WJC West 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 Information

    CAA section 112(c)(6) requires the EPA to take action with respect
to the sources of seven specific persistent, bioaccumulative HAP. The
section states, ``With respect to alkylated lead compounds, polycyclic
organic matter, hexachlorobenzene, mercury, polychlorinated biphenyls,
2,3,7,8-tetrachlorodibenzofurans and 2,3,7,8-tetrachlorodibenzo-p-
dioxin, the Administrator shall, not later than 5 years after November
15, 1990, list categories and subcategories of sources assuring that
sources accounting for not less than 90 per centum of the aggregate
emissions of each such pollutant are subject to standards under
subsection (d)(2) or (d)(4) of this section.''
    CAA section 112(c)(6) requires the EPA to ensure that source
categories responsible for at least 90 percent of the aggregate
emissions of each of the seven specified pollutants are subject to
standards under CAA sections 112(d)(2) or 112(d)(4). It requires the
EPA to list, by November 15, 1995, source categories assuring that
sources responsible for 90 percent of the aggregate emissions are
subject to emission standards pursuant to CAA section 112(d)(2) or
(d)(4), and to promulgate such standards by November 15, 2000. Under
CAA section 112(d)(2), the EPA imposes emission standards that require
``the maximum degree of reduction in emissions of the [HAP]'' that the
EPA concludes are achievable based on a consideration of factors
identified in the statute. CAA section 112(d)(2). These standards are
referred to as ``maximum achievable control technology'' or ``MACT''
standards. CAA section 112(d)(4) authorizes the EPA to set a health-
based standard for a limited set of HAP for which a health threshold
has been established, and that standard must provide for ``an ample
margin of safety.'' CAA section 112(d)(4).
    On December 16, 2014, the EPA published in the Federal Register the
proposed determination concluding that the requirements of CAA section
112(c)(6) were fulfilled in February of 2011. 79 FR 74656 (December 16,
2014).\1\ The proposed determination provided a detailed summary of the
litigation history regarding this action and provided an opportunity
for comment on the EPA's proposed determination that it has fulfilled
the requirements of CAA section 112(c)(6). The proposed rulemaking
explained the basis for the agency's proposed determination by
identifying the promulgated CAA section 112(d)(2) or 112(d)(4)
standards that collectively satisfy the obligation and describing how
the EPA determined which regulations would collectively satisfy the 90
percent requirement under CAA section 112(c)(6) using the updated 1990
baseline inventory of source categories that emit CAA section 112(c)(6)
HAP, which was presented in Table 1 of the proposed determination. 79
FR at 74661-74671.
---------------------------------------------------------------------------

    \1\ The EPA's initial determination was signed on February 21,
2011, and published in the Federal Register on March 21, 2011.
---------------------------------------------------------------------------

III. How has the EPA satisfied its obligation under CAA section
112(c)(6)?

A. What are the emissions standards that the EPA has promulgated to
meet the 90 percent requirement under CAA section 112(c)(6)?

    This action finalizes the EPA's proposed determination that the
Agency has promulgated emissions standards for source categories
pursuant to CAA sections 112(d)(2) and (4) sufficient to satisfy the
CAA section 112(c)(6) requirement that sources accounting for not less
than 90 percent of the aggregate emissions of seven specific HAP are
subject to standards under CAA sections 112(d)(2) or 112(d)(4).\2\
Table 2 of the December 2014 proposal provided a list of the emissions
standards, including the name of each of the source categories, the
name of the emissions standards that apply, and the rule citation for
each (i.e., CFR part and subpart). 79 FR 74674-74677, December 16,
2014. Table 3 of the 2014 proposal provided a list of the specific
regulations (including CFR citations, part and subpart) that address 90
percent or more of each of the CAA section 112(c)(6) HAP. 79 FR at
74677. After considering and evaluating all public comments received in
response to the proposed rule, we finalize our determination that the
EPA has satisfied the CAA section 112(c)(6) requirement to establish
CAA section 112(d)(2) or (4) standards for source categories that
account for not less than 90 percent of the seven HAP listed in CAA
section 112(c)(6).
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    \2\ In addition to standards issued pursuant to section
112(d)(2) or (4), EPA also includes standards issued pursuant to
section 129 as satisfying the 112(c)(6) requirement because section
129(a)(2) requires MACT standards that are virtually identical to
the those standards required pursuant to section 112(d)(2). In
addition, section 129(h)(3)(A) states that ``the performance
standards under subsection (a) of this section and section [111] of
this title applicable to a category of solid waste incineration
units shall be deemed standards under section [112](d)(2)of this
title.''
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B. What are the surrogate pollutants used by the EPA when establishing
CAA section 112(d)(2) standards for the source categories identified in
the proposed determination?

    As noted in the proposed rule, the emissions standards that
collectively satisfy the 90 percent requirement under CAA section
112(c)(6) were set by the EPA under two approaches: (1) Through
standards that directly regulated CAA section 112(c)(6) HAP; and (2)
through standards that set emission limits for another HAP or
compound,\3\ which serves as a surrogate for the CAA section 112(c)(6)
HAP and other non-112(c)(6) HAP emitted from the source category.
---------------------------------------------------------------------------

    \3\ Some standards used non-HAP compounds (or groups of
compounds) as surrogates for HAP.
---------------------------------------------------------------------------

    The EPA noted in the proposed determination that, with respect to
some of the CAA section 112(d)(2) standards that utilized the surrogacy
approach, specifically those promulgated prior to the EPA's development
of the baseline emissions inventory for CAA section 112(c)(6) and
issuance of the 1998 listing notice, the EPA did not specifically
indicate in those rulemaking records that the standards would be
counted towards satisfying the 90 percent requirement in CAA section
112(c)(6). For these standards, the 2014 proposed determination
explained how the surrogate standards control the CAA section 112(c)(6)
HAP along with other HAP from the source categories and ensure that the
sources of CAA section 112(c)(6) HAP emissions are ``subject to

standards'' for the purposes of CAA section 112(c)(6). The information
presented in the proposed determination simply described the actions
taken in these prior rulemakings and explained how the surrogate
standards control the relevant CAA section 112(c)(6) HAP. The proposed
determination did not reopen these prior actions. All those standards
were subject to their own notice and comment rulemaking processes
consistent with CAA sections 112 and 307(d), and, in several cases, to
judicial review as provided by the strict statute of limitations
imposed by CAA section 307(b)(1).
    Table 1 of this preamble provides a list of the source categories
listed under CAA section 112(c)(6), the names of the national standards
that apply to those source categories, the Federal Register citations
and CFR part and subparts for the rules, and the CAA section 112(c)(6)
HAP regulated by those standards.

Table 1--List of Source Categories, National Emissions Standards, and the 112(c)(6) HAP Subject to These Standards, To Fulfill the CAA Section 112(c)(6)
                                                                       Obligations
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 Section 112(c)(6) source category   National emissions standard                            Final rule Federal
                name                           name(s)             CFR part and  subpart    Register citation              112(c)(6) Pollutant
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aerospace Industry (Surface          National Emission Standards  40 CFR part 63 subpart  60 FR 45948,           Mercury, POM.
 Coating).                            for Hazardous Air            GG.                     September 1, 1995.
                                      Pollutants for the
                                      Aerospace Industries.
Alkylated Lead Production..........  National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     Alkylated Lead.
                                      for Organic Hazardous Air    F.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     Alkylated Lead.
                                      for Organic Hazardous Air    G.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry for
                                      Process Vents, Storage
                                      Vessels, Transfer
                                      Operations, and Wastewater.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     Alkylated Lead.
                                      for Organic Hazardous Air    H.                      22, 1994.
                                      Pollutants for Equipment
                                      Leaks.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     Alkylated Lead.
                                      for Organic Hazardous Air    I.                      22, 1994.
                                      Pollutants for Certain
                                      Processes Subject to the
                                      Negotiated Regulation for
                                      Equipment Leaks.
Asphalt Roofing Production.........  National Emission Standards  40 CFR part 63 subpart  68 FR 24562, May 7,    POM.
                                      for Hazardous Air            LLLLL.                  2003.
                                      Pollutants for Asphalt
                                      Processing and Asphalt
                                      Roofing Manufacturing.
Blast Furnace and Steel Mills......  National Emission Standards  40 CFR part 63 subpart  68 FR 27645, May 20,   POM.
                                      for Hazardous Air            FFFFF.                  2003.
                                      Pollutants for Integrated
                                      Iron and Steel
                                      Manufacturing Facilities.
Chemical Manufacturing: Cyclic       National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
 Crude and Intermediate Production.   for Organic Hazardous Air    F.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    G.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry for
                                      Process Vents, Storage
                                      Vessels, Transfer
                                      Operations, and Wastewater.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    H.                      22, 1994.
                                      Pollutants for Equipment
                                      Leaks.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    I.                      22, 1994.
                                      Pollutants for Certain
                                      Processes Subject to the
                                      Negotiated Regulation for
                                      Equipment Leaks.
Chlorinated Solvents Production....  National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     HCB.
                                      for Organic Hazardous Air    F.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     HCB.
                                      for Organic Hazardous Air    G.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry for
                                      Process Vents, Storage
                                      Vessels, Transfer
                                      Operations, and Wastewater.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     HCB.
                                      for Organic Hazardous Air    H.                      22, 1994.
                                      Pollutants for Equipment
                                      Leaks.

                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     HCB.
                                      for Organic Hazardous Air    I.                      22, 1994.
                                      Pollutants for Certain
                                      Processes Subject to the
                                      Negotiated Regulation for
                                      Equipment Leaks.
Coke Ovens: By-Product Recovery      National Emission Standard   40 CFR part 61 subpart  54 FR 38073,           POM.
 Plants.                              for Benzene Emissions from   L.                      September 14, 1989.
                                      Coke By-Product Recovery
                                      Plants.
Coke Ovens: Charging, Topside &      National Emission Standards  40 CFR part 63 subpart  58 FR 57898, October   POM.
 Door Leaks.                          for Hazardous Air            L.                      27, 1993.
                                      Pollutants for Coke Oven
                                      Batteries.
                                     National Emission Standards  40 CFR part 63 subpart  68 FR 18007, April     POM.
                                      for Hazardous Air            CCCCC.                  14, 2003.
                                      Pollutants for Coke Ovens:
                                      Pushing, Quenching, and
                                      Battery Stacks.
Coke Ovens: Pushing, Quenching &     National Emission Standards  40 CFR part 63 subpart  58 FR 57898, October   POM.
 Battery Stacks.                      for Hazardous Air            L.                      27, 1993.
                                      Pollutants for Coke Oven
                                      Batteries.
                                     National Emission Standards  40 CFR part 63 subpart  68 FR 18007, April     POM.
                                      for Hazardous Air            CCCCC.                  14, 2003.
                                      Pollutants for Coke Ovens:
                                      Pushing, Quenching, and
                                      Battery Stacks.
Commercial Printing: Gravure.......  National Emission Standards  40 CFR part 63 subpart  61 FR 27132, May 30,   POM.
                                      for Hazardous Air            KK.                     1996.
                                      Pollutants: Printing and
                                      Publishing Industry.
Electric Arc Furnaces (EAF)--        National Emission Standards  40 CFR part 63 subpart  72 FR 74088, December  Mercury.
 Secondary Steel.                     for Hazardous Air            YYYYY.                  28, 2007.
                                      Pollutants for Area
                                      Sources: Electric Arc
                                      Furnace Steelmaking
                                      Facilities.
Fabricated Metal Products..........  National Emission Standards  40 CFR part 63 subpart  69 FR 129, January 2,  POM.
                                      for Hazardous Air            MMMM.                   2004.
                                      Pollutants: Surface
                                      Coating of Miscellaneous
                                      Metal Parts and Products.
Gasoline Distribution (Stage 1)....  National Emission Standards  40 CFR part 63 subpart  59 FR 64303, December  POM.
                                      for Hazardous Air            R.                      14, 1994.
                                      Pollutants for Gasoline
                                      Distribution Facilities
                                      (Bulk Gasoline Terminals
                                      and Pipeline Breakout
                                      Stations).
Gold Mines.........................  National Emission Standards  40 CFR part 63 subpart  76 FR 9450, February   Mercury.
                                      for Hazardous Air            EEEEEEE.                17, 2011.
                                      Pollutants: Gold Mine Ore
                                      Processing and Production
                                      Area Source Category.
Hazardous Waste Incineration.......  National Emission Standards  40 CFR part 63 subpart  64 FR 52827,           POM, Mercury, PCB, Dioxins, Furans.
                                      for Hazardous Air            EEE.                    September 30, 1999;
                                      Pollutants from Hazardous                            70 FR 59402, October
                                      Waste Combustors.                                    12, 2005.
Industrial Organic Chemicals         National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
 Manufacturing.                       for Organic Hazardous Air    F.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    G.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry for
                                      Process Vents, Storage
                                      Vessels, Transfer
                                      Operations, and Wastewater.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    H.                      22, 1994.
                                      Pollutants for Equipment
                                      Leaks.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    I.                      22, 1994.
                                      Pollutants for Certain
                                      Processes Subject to the
                                      Negotiated Regulation for
                                      Equipment Leaks.
Industrial Stationary IC Engines--   National Emission Standards  40 CFR part 63 subpart  69 FR 33473, June 15,  POM.
 Diesel.                              for Hazardous Air            ZZZZ.                   2004.
                                      Pollutants for Stationary
                                      Reciprocating Internal
                                      Combustion Engines.
Industrial Stationary IC Engines--   National Emission Standards  40 CFR part 63 subpart  69 FR 33473, June 15,  POM.
 Natural Gas.                         for Hazardous Air            ZZZZ.                   2004.
                                      Pollutants for Stationary
                                      Reciprocating Internal
                                      Combustion Engines.

Industrial/Commercial/Institutional  National Emission Standards  40 CFR part 63 subpart  76 FR 15608, March     POM, Mercury, Dioxins, Furans.
 Boilers.                             for Hazardous Air            DDDDD.                  21, 2011.
                                      Pollutants for Industrial/
                                      Commercial/Institutional
                                      Boilers and Process
                                      Heaters.
                                     National Emission Standards  40 CFR part 63 subpart  76 FR 15554, March     POM, Mercury, Dioxins, Furans.
                                      for Hazardous Air            JJJJJJ.                 21, 2011.
                                      Pollutants for Area
                                      Sources: Industrial,
                                      Commercial, and
                                      Institutional Boilers.
Lightweight Aggregate Kilns........  National Emission Standards  40 CFR part 63 subpart  64 FR 52827,           Mercury, Dioxins, Furans.
                                      for Hazardous Air            EEE.                    September 30, 1999;
                                      Pollutants from Hazardous                            70 FR 59402, October
                                      Waste Combustors.                                    12, 2005.
Medical Waste Incineration.........  Standards of Performance     40 CFR part 60 subpart  74 FR 51367, October   POM, Mercury, PCB, Dioxins, Furans.
                                      and Emissions Guidelines     Ce, Ec; & 40 CFR part   6, 2009.
                                      for Hospitals/Medical/       62 subpart HHH.
                                      Infectious Waste
                                      Incinerators.
Mercury Cell Chlor Alkali            National Emission Standards  40 CFR part 63 subpart  68 FR 70903, December  Mercury.
 Production.                          for Hazardous Air            IIIII.                  19, 2003.
                                      Pollutants: Mercury
                                      Emissions from Mercury
                                      Cell Chlor Alkali Plants.
Municipal Waste Combustion.........  Standards of Performance     40 CFR part 60 subpart  71 FR 27324, May 10,   POM, Mercury, PCB, Dioxins, Furans.
                                      for New Stationary Sources   Cb, Ea, Eb; & 40 CFR    2006.
                                      and Emission Guidelines      part 62 subpart FFF.
                                      for Existing Sources:
                                      Large Municipal Waste
                                      Combustion Units.
                                     Standards of Performance     40 CFR part 60 subpart  65 FR 76349, December  POM, Mercury, PCB, Dioxins, Furans.
                                      for New Stationary Sources   AAAA, BBBB & 40 CFR     6, 2000; 65 FR
                                      and Emission Guidelines      part 62 subpart JJJ.    76337, December 6,
                                      for Existing Stationary                              2000.
                                      Sources: Small Municipal
                                      Waste Combustion Units.
Naphthalene Production.............  National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    F.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    G.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry for
                                      Process Vents, Storage
                                      Vessels, Transfer
                                      Operations, and Wastewater.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    H.                      22, 1994.
                                      Pollutants for Equipment
                                      Leaks.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    I.                      22, 1994.
                                      Pollutants for Certain
                                      Processes Subject to the
                                      Negotiated Regulation for
                                      Equipment Leaks.
Paints and Allied Products (Major).  National Emission Standards  40 CFR part 63 subpart  68 FR 63851, November  POM.
                                      for Hazardous Air            FFFF.                   10, 2003.
                                      Pollutants: Miscellaneous
                                      Organic Chemical
                                      Manufacturing.
Paper Coated and Laminated,          National Emission Standards  40 CFR part 63 subpart  67 FR 72329, December  POM.
 Packaging.                           for Hazardous Air            JJJJ.                   4, 2002.
                                      Pollutants: Paper and
                                      Other Web Coating.
Pesticides Manufacture &             National Emission Standards  40 CFR part 63 subpart  64 FR 33549, June 23,  HCB.
 Agricultural Chemicals.              for Hazardous Air            MMM.                    1999.
                                      Pollutants: Pesticide
                                      Active Ingredient
                                      Production.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     HCB.
                                      for Organic Hazardous Air    F.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     HCB.
                                      for Organic Hazardous Air    G.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry for
                                      Process Vents, Storage
                                      Vessels, Transfer
                                      Operations, and Wastewater.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     HCB.
                                      for Organic Hazardous Air    H.                      22, 1994.
                                      Pollutants for Equipment
                                      Leaks.

Petroleum Refining: All Processes..  National Emission Standards  40 CFR part 63 subpart  60 FR 43244, August    POM.
                                      for Hazardous Air            CC.                     18, 1995.
                                      Pollutants from Petroleum
                                      Refineries.
                                     National Emission Standards  40 CFR part 63 subpart  67 FR 17761, April     POM.
                                      for Hazardous Air            UUU.                    11, 2002.
                                      Pollutants for Petroleum
                                      Refineries: Catalytic
                                      Cracking Units, Catalytic
                                      Reforming Units, and
                                      Sulfur Recovery Units.
Phthalic Anhydride Production......  National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    F.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    G.                      22, 1994.
                                      Pollutants from the
                                      Synthetic Organic Chemical
                                      Manufacturing Industry for
                                      Process Vents, Storage
                                      Vessels, Transfer
                                      Operations, and Wastewater.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    H.                      22, 1994.
                                      Pollutants for Equipment
                                      Leaks.
                                     National Emission Standards  40 CFR part 63 subpart  59 FR 19402, April     POM.
                                      for Organic Hazardous Air    I.                      22, 1994.
                                      Pollutants for Certain
                                      Processes Subject to the
                                      Negotiated Regulation for
                                      Equipment Leaks.
Plastics Material and Resins         National Emission Standards  40 CFR part 63 subpart  61 FR 48208,           POM.
 Manufacturing.                       for Hazardous Air            JJJ.                    September 12, 1996.
                                      Pollutants for Group IV
                                      Polymers and Resins.
Portland Cement Manufacture:         National Emission Standards  40 CFR part 63 subpart  64 FR 52827,           POM, Mercury, Dioxins, Furans.
 Hazardous Waste Kilns.               for Hazardous Air            EEE.                    September 30, 1999;
                                      Pollutants from Hazardous                            70 FR 59402, October
                                      Waste Combustors.                                    12, 2005.
Portland Cement Manufacture: Non-    National Emission Standards  40 CFR part 63 subpart  75 FR 54970,           POM, Mercury, Dioxins, Furans.
 Hazardous Waste Kilns.               for Hazardous Air            LLL.                    September 9, 2010.
                                      Pollutants for the
                                      Portland Cement
                                      Manufacturing Industry.
Primary Aluminum Production........  National Emission Standards  40 CFR part 63 subpart  62 FR 52384, October   POM, Mercury, Dioxins, Furans.
                                      for Hazardous Air            LL.                     7, 1997.
                                      Pollutants for Primary
                                      Aluminum Reduction Plants.
Pulp and Paper--Kraft Recovery       National Emission Standards  40 CFR part 63 subpart  63 FR 18504, April     POM, Mercury.
 Furnaces.                            for Hazardous Air            MM.                     15, 1998; 66 FR
                                      Pollutants for Chemical                              3180, January 12,
                                      Recovery Combustion                                  2001.
                                      Sources at Kraft, Soda,
                                      Sulfite, and Stand-Alone
                                      Semichemical Pulp Mills.
Pulp and Paper--Lime Kilns.........  National Emission Standards  40 CFR part 63 subpart  63 FR 18504, April     POM, Mercury.
                                      for Hazardous Air            MM.                     15, 1998; 66 FR
                                      Pollutants for Chemical                              3180, January 12,
                                      Recovery Combustion                                  2001.
                                      Sources at Kraft, Soda,
                                      Sulfite, and Stand-Alone
                                      Semichemical Pulp Mills.
Secondary Aluminum Smelting........  National Emission Standards  40 CFR part 63 subpart  65 FR 15689, March     Dioxins, Furans.
                                      for Hazardous Air            RRR.                    23, 2000.
                                      Pollutants for Secondary
                                      Aluminum Production.
Secondary Lead Smelting............  National Emission Standards  40 CFR part 63 subpart  60 FR 32587, June 23,  POM, Dioxins, Furans.
                                      for Hazardous Air            X.                      1995; 77 FR 555,
                                      Pollutants for Secondary                             January 5, 2012.
                                      Lead Smelting.
Sewage Sludge Incineration.........  Standards of Performance     40 CFR part 60          76 FR 15372, March     Mercury.
                                      for New Stationary Sources   subparts LLLL, MMMM.    21, 2011.
                                      and Emission Guidelines
                                      for Existing Sources:
                                      Sewage Sludge Incineration
                                      Units.
Ship Building and Repair (Surface    National Emission Standards  40 CFR part 63 subpart  60 FR 64330, December  POM.
 Coating).                            for Hazardous Air            II.                     15, 1995.
                                      Pollutants for
                                      Shipbuilding and Ship
                                      Repair (Surface Coating).
Transportation Equipment             National Emission Standards  40 CFR part 63 subpart  69 FR 20967, April     POM.
 Manufacturing (SICs Combined).       for Hazardous Air            PPPP.                   19, 2004; 69 FR
                                      Pollutants: Surface                                  22601, April 26,
                                      Coating of Plastic Parts                             2004.
                                      and Products.

Wood Household Furniture             National Emission Standards  40 CFR part 63 subpart  60 FR 62930, December  POM.
 Manufacturing.                       for Hazardous Air            JJ.                     7, 1995.
                                      Pollutants from Wood
                                      Furniture Manufacturing
                                      Operations.
--------------------------------------------------------------------------------------------------------------------------------------------------------

IV. Summary of Significant Comments and Responses

    During the public comment period for the proposed determination, we
received comments from three organizations: the Council of Industrial
Boiler Owners (CIBO), the Coalition for Clean Air Implementation
(CCAI), and Sierra Club. The CIBO and CCAI submitted comments
supporting our proposed determination that we have fulfilled the CAA
section 112(c)(6) obligations and agreed with our use of surrogate
pollutants. Sierra Club submitted comments claiming that a number of
previously promulgated standards identified in the proposed
determination are unlawful for purposes of CAA section 112(d)(2) such
that those standards may not count toward satisfying the 90 percent
requirement in CAA section 112(c)(6). A summary of significant public
comments received during the comment period and the EPA's response to
those comments are provided below in this section of this preamble. All
the remaining public comments received during the comment period and
the EPA's responses to those comments are presented in the Summary of
Public Comments and EPA's Responses for the Completion of Requirements
to Promulgate Standards Under CAA Section 112(c)(6) 2015 Final Rule
document, which is available in the docket for this action.

A. General/Legal Opposition to the EPA's Surrogacy Determinations

    Comment: One commenter states that ``for source categories listed
under section [112](c)(6), the EPA must set a MACT standard (i.e., a
standard under section [112](d)(2)-(3)) for each section 112(c)(6)
pollutant for which the source was listed.'' \4\ See Desert Citizens
Against Pollution v. EPA, 699 F.3d 524, 527-528 (D.C. Cir. 2012).\5\
Thus, the commenter states, ``to satisfy section 112(d)(2), the EPA
must determine the maximum achievable degree of reduction for each
hazardous air pollutant that a source category emits.'' The commenter
states that the CAA also specifies a ``floor'' for the reduction that
the EPA must require for each pollutant. Therefore, the commenter
believes that the EPA's claim that it can meet its obligations under
section 112(c)(6) by setting a single limit on the aggregate emissions
of all HAP from an industrial source category is contrary to the
language in CAA and violates the text of sections 112(c)(6) and 112(d),
reflecting an unreasonable statutory interpretation.
---------------------------------------------------------------------------

    \4\ The commenter notes that section 112(c)(6) also allows the
EPA to set standards for these pollutants under section 112(d)(4) if
a health threshold has been established for that pollutant. CAA
sections 112(c)(6) and (d)(4). This provision is not at issue
because the EPA has not established health thresholds for any of the
section 112(c)(6) pollutants at issue here.
    \5\ Accepting as ``reasonable'' the EPA's interpretation of
section 112 as requiring it to set section 112(d)(2) standards for
the section 112(c)(6) pollutants when it regulates a category of
area sources listed pursuant to section 112(c)(6).
---------------------------------------------------------------------------

    The commenter states that although the EPA may set surrogate
standards for HAP where it is reasonable to do so, see National Lime,
233 F.3d at 637, setting surrogate standards instead of direct
standards for HAP does not, according to the commenter, excuse the EPA
from its clear statutory obligation to assure that each HAP emitted by
a source category is reduced to the extent that sections 112(d)(2)-(3)
requires. The commenter maintains that the United States Court of
Appeals for the District of Columbia Circuit has made clear, a
surrogate is reasonable only if it allows the EPA to identify ``the
best achieving sources, and what they can achieve'' with respect to the
target HAP. Sierra Club v. EPA, 353 F.3d 976, 985 (D.C. Cir. 2004).
    As an example of a reasonable surrogate, the commenter asserts that
particulate matter (PM) is a reasonable surrogate for metallic HAP only
where the EPA demonstrates that (1) the metallic HAP are ``invariably
present'' in the surrogate pollutant such that there is a strong
correlation between the two; (2) the control technology used for PM
control ``indiscriminately captures'' the metallic HAP along with the
PM; and (3) the means by which sources achieve reductions in PM are the
only means by which they achieve reductions'' in metallic HAP
emissions. National Lime, 233 F.3d at 639; Sierra Club, 353 F.3d at
984. The commenter maintains that the United States Court of Appeals
for the District of Columbia Circuit has held repeatedly that what
sources ``achieve'' with respect to a given HAP is not limited to what
they achieve intentionally, but also includes lower emission levels
achieved through the use of cleaner fuels or raw materials regardless
of whether such use reflects any deliberate intent to reduce emissions.
Sierra Club v. EPA, 479 F.3d 875, 883 (D.C. Cir.2007) (citing National
Lime, 233 F.3d at 640).
    The commenter states that the EPA's use of ``total HAP,'' ``total
organic HAP,'' and other such aggregate measures as ``surrogates'' for
pollutants that fit into those categories is a definition maneuver and
not a technical determination. The commenter states that this approach
to surrogacy is unlawful because it conflicts with EPA's statutory
obligation under sections 112(c)(6) and 112(d), and also the commenter
asserts with the EPA's own interpretation of those provisions, see
Desert Citizens, 699 F.3d at 527-28, which is that the EPA must set
MACT standards for each of the section 112(c)(6) pollutants for which
each source category was listed. The commenter states there is nothing
left of this obligation if the EPA can simply define a category of
pollutants (such as total HAP) broad enough to include all the
pollutants it must regulate and then set an aggregate limit for the
category.
    Additionally, the commenter states that saying that POM is a
constituent of total HAP, for example, is just a different way of
saying it is a HAP--something that Congress already clearly indicated
by listing POM as a HAP in section 112(b). The commenter believes that
such statements do nothing to demonstrate that emissions of total HAP
identify the best performing sources with respect to POM and what
sources can achieve with respect to POM. The commenter believes that if
the EPA had authority to create surrogates by simply defining a group
of pollutants to include all the pollutants it must regulate, it would
abrogate the limits that decisions of the United States Court of
Appeals for

the District of Columbia Circuit have formulated to ensure that the
EPA's use of surrogates is reasonable. The commenter states that there
would be nothing left, for example, of the requirement that the HAP to
be regulated be ``invariably present'' in the surrogate pollutant,
National Lime, 233 F.3d at 639, if the EPA could simply define the
surrogate ``pollutant'' as a group of pollutants that includes the
regulated pollutant.
    The commenter argues that section 112(c)(6) is a provision that
specifically addresses seven persistent bioaccumulative toxics that
Congress recognized were particularly harmful. The commenter believes
that for sources the EPA lists as contributing to 90 percent of the
total emissions of one or more of these pollutants, the EPA must set a
standard for that pollutant ensuring the maximum emissions reduction.
The commenter states that Congress would not have singled out these
seven pollutants if it intended for the EPA only to set a single limit
for the aggregate of emissions of all the different HAP.
    The commenter states that even if it were permissible in general
for the EPA to evade its standard-setting obligations by defining the
surrogate ``pollutant'' as a group of pollutants, the EPA's surrogacy
claims in this rule are unlawful and arbitrary because they lack
supporting data or analysis. The commenter argues that the EPA's
surrogacy explanations in the proposed determination are standards
under section 307(d) because they are first-time claims that the
relevant pollutants are subject to standards. The EPA must according to
the commenter comply with the requirements of section 307(d) governing
CAA rulemakings for all of those previously issued standards. The
commenter maintains the EPA has not complied with these requirements
because according to the commenter the EPA has not provided
documentation, data, or analysis in support of its proposed
determination. For this reason, the commenter concludes that the EPA
has violated section 307(d) by failing to explain the ``methodology
used in obtaining the data and in analyzing the data'' in the proposed
determination, by failing to provide opportunity for informed public
participation and input, and by unlawfully basing the Agency's
conclusions on information or data which has not been made available to
the public through the docket. The commenter also believes that the EPA
has acted arbitrarily and capriciously by failing to provide
substantial record evidence in support of its proposed section
112(c)(6) determination, by failing to consider relevant factors, and
by failing to provide a rational connection between the facts found and
the conclusion made. Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State
Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42-43. The commenter gives
examples of specific surrogacy claims for specific source categories
and processes that it believes are unlawful and arbitrary. We address
the specific claims in the Summary of Public Comments and EPA's
Responses for the Completion of Requirements to Promulgate Standards
Under CAA Section 112(c)(6) 2015 Final Rule document, which is
available in the docket for this action.
    Response: The commenter misinterprets the CAA, mischaracterizes the
EPA's proposed determination, and provides comments challenging the
substance of a number of previously issued EPA rules. As explained
below, the comments challenging the legitimacy of the standards on
which EPA relies to demonstrate it has satisfied its obligations under
CAA section 112(c)(6) are far outside the scope of the proposed CAA
section 112(c)(6) determination at issue. The EPA, therefore, has no
obligation to respond to those comments.
    The proposed determination memorializes and provides notice that
the EPA has fulfilled, via numerous other previous regulatory actions,
its duties under section 112(c)(6) of the CAA. The proposal lists CAA
section 112(d)(2) or 112(d)(4) standards previously promulgated by the
EPA and proposed the conclusion that the listed standards cover sources
that, in the aggregate, emit 90 percent or more of the pollutants
specifically identified in CAA section 112(c)(6). The commenter does
not challenge that conclusion. In fact, no commenter suggests that the
source categories listed did not emit, in the aggregate prior to
regulation, 90 percent or more of the specified pollutants or that the
source categories are not subject to the CAA section 112(d)(2)
standards identified. Instead, the commenter seeks to use the proposed
determination to reopen standards that were finalized by the EPA in
some cases more than 20 years ago. The commenter argues that the EPA
must now demonstrate, for each previously promulgated rule, that each
standard reduces HAP ``to the extent that [112] (d)(2)-(3) requires,''
that in each rulemaking the EPA properly identified ``the best
performing sources,'' and that the EPA must provide documentation, data
and analysis to support the validity of the standards in the previously
promulgated rules. CAA section 112(c)(6) imposes no such obligation on
the EPA. As explained below, the commenter aims to collaterally attack
prior EPA actions. All comments that raise such collateral attacks are
outside the scope of the proposed CAA section 112(c)(6) determination.
All of the rules relied upon by the EPA in this determination were
promulgated through notice and comment rulemaking consistent with CAA
section 307(d), and were final agency actions subject to judicial
review. CAA section 112(c)(6) does not provide commenters another
opportunity to belatedly challenge these prior EPA actions, nor does it
mandate that the EPA re-promulgate or otherwise re-open for purposes of
section 112(c)(6) standards that were previously promulgated under
section 112(d)(2).
    As an initial matter, it is important to understand the specific
duties that CAA section 112(c)(6) imposes on the EPA, especially since
the commenter consistently paraphrases the statutory language to assert
there are duties beyond which the CAA requires by its terms. CAA
section 112(c)(6) requires the EPA, with respect to seven specified
HAP--alkylated lead compounds, polycyclic organic matter,
hexachlorobenzene, mercury, polychlorinated biphenyls, 2,3,7,8-
tetrachlorodibenzofurans and 2,3,7,8-tetrachlorodibenzo-p-dioxin--to
``list categories and subcategories of sources assuring that sources
accounting for not less than 90 per centum of the aggregate emissions
of each such pollutant are subject to standards under subsection (d)(2)
or (d)(4) of this section.'' The provision requires the listing to be
done by November 15, 1995, and requires that sources accounting for not
less than 90 percent of aggregate emissions of each of the enumerated
pollutants be subject to CAA section 112(d)(2) or (4) standards by
November 15, 2000. CAA section 112(c)(6) does not require the EPA to
submit a report stating that the agency has subjected those sources to
such standards, or establish a deadline for any such report. Sierra
Club v. EPA, 699 F.3d 530, 536 (D.C. Cir. 2012) (Henderson
Concurring)(``EPA is under no obligation, statutory or otherwise, to
inform anyone that it has satisfied the requirements of section
112(c)(6).''). Moreover, while CAA section 112(c)(6) gives the EPA
authority to list source categories, the rules which establish
standards for those source categories are promulgated pursuant to
separate CAA provisions.
    The CAA section 112(d)(2) standards (also referred to as maximum
achievable control technology or MACT standards), which commenter seeks
to collaterally

attack, regulate HAP emitted from major sources and in some instances
area sources and were promulgated in accordance with the following CAA
provisions. CAA section 112(c)(1) requires the EPA to list all major
sources and authorizes the EPA to list area sources, and section
112(d)(1) requires the EPA to regulate all HAP from major sources
pursuant to CAA section 112(d)(2) or (d)(4). CAA section 112(e)(1)(A)-
(E) imposes sequential milestones for the EPA to complete issuance of
MACT standards, and requires that the final set of such standards be
promulgated by November 15, 2000, the same date by which under CAA
section 112(c)(6) sources accounting for 90 percent of the enumerated
HAP were required to have become subject to CAA section 112(d)(2) or
(4) standards. Therefore, for major sources, CAA section 112(c)(6) is
redundant with respect to the HAP to be regulated, the type of
standards required, and the ultimate timing for completion of issuing
such standards. The HAP specifically listed in CAA section 112(c)(6)
are also on the CAA section 112(b)(1) list of HAP and, thus, the CAA
section 112(d)(1) obligation to set CAA section 112(d)(2) or (d)(4)
standards for all HAP from major sources applies equally to the CAA
section 112(c)(6) HAP. CAA section 112(c)(6) adds nothing substantive
to this requirement. Even the CAA section 112(e)(1) deadlines for
promulgating such standards is ultimately identical to the deadline in
CAA section 112(c)(6).\6\ As such, it is irrelevant whether the EPA
mentioned CAA section 112(c)(6) during the rulemaking for any standard
for a major source category, including standards where the Agency
regulated the area sources in the category at the same time and in the
same manner as the major sources (i.e. pursuant to CAA section
112(d)(2)).\7\
---------------------------------------------------------------------------

    \6\ The primary impacts of CAA section 112(c)(6) are to require
the EPA to list area sources if major sources do not account for at
least 90 percent of each of the seven HAP, and to limit the EPA's
discretion to set so-called generally available control technology
or GACT standards for area sources. Most relevant here is the
limitation on the EPA's authority to establish GACT standards. CAA
section 112(d)(5) provides that, for listed area sources, the EPA
may set emission standards that ``provide for the use of generally
available control technologies or management practices by such
sources to reduce emissions of hazardous air pollutants.'' CAA
section 112(c)(6) removes the EPA's discretion to establish GACT
standards for the seven section 112(c)(6) HAP emitted if an area
source category must be regulated pursuant to CAA section 112(d)(2)
or (4) to ensure that sources accounting for not less than 90
percent of the seven HAP are subject to CAA section 112 (d)(2) or
(d)(4) standards. As shown in this notice, none of the standards
applicable to area sources that the EPA listed and relied on to
demonstrate that it has met its obligations under CAA section
112(c)(6) were established pursuant to CAA section 112(d)(5).
    \7\ Several of the rulemakings that the commenter collaterally
attacks regulated major and area sources together and the Agency
established the same section CAA section 112(d)(2) standard for both
the major and the area sources in the categories. The commenter
makes no distinction between major and area sources in its comments.
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    For all the rules that the commenter seeks to collaterally attack,
the public was on notice during each specific rulemaking that the EPA
was setting MACT standards for the HAP, including the CAA section
112(c)(6) HAP, emitted by the source category. Parties, including the
commenter, could have challenged the adequacy of those standards at the
time they were issued if they believed the standards did not
sufficiently reduce the HAP emitted by the source category, in whatever
manner those standards took with respect to regulating each HAP
individually or collectively through a surrogate. See National Lime
Association v. EPA, 33 F.3d 625, 633-34 (D.C. Cir. 2000) (finding that
CAA section 112(d)(1) requires the EPA to establish standards for all
HAP emitted from major sources). Any challenges to the legitimacy of
the standards, including challenges suggesting that certain HAP were
not adequately regulated, should have been raised during the rulemaking
for the standards. If any issue remained when the standards were
finalized, the proper recourse would have been to petition for judicial
review pursuant to CAA section 307(b). That provision provides that
``[a] petition for review of action of the [EPA] Administrator in
promulgating . . . any emission standard or requirement under section
112 of this title . . . shall be filed within sixty days from the date
notice of such promulgation. . . . appears in the Federal Register. . .
.'' CAA section 307(b)(1). Once the 60-day period has lapsed, a party
may not raise arguments that ``were available to them at the time the
rule was adopted.'' Nat'l Mining Ass'n v. DOI, 70 F.3d 1345, 1350 (D.C.
Cir. 1995).
    For the reasons stated above, because the commenter challenges the
sufficiency of the underlying standards as they apply to certain CAA
section 112(c)(6) HAP, the commenter should have raised these issues in
timely, direct challenges to those rules. CAA section 112(c)(6) does
not allow for challenges to the legitimacy of CAA section 112(d)
standards adopted in prior rulemakings outside the 60-day window for
challenging those standards established in CAA section 307(b)(1).
Moreover, in the proposed determination, EPA did not re-opened those
previously promulgated standards, either to review their adequacy for
controlling any emitted HAP (including section 112(c)(6) HAP) under
section 112(d)(2), or for any other purpose. Therefore, this final
determination itself cannot provide a new opportunity to challenge
those previously promulgated rules under either section 112(d)(2) or
section 112(c)(6).
    In addition to raising belated comments, the commenter argues that
CAA section 112(c)(6) requires the EPA to set a ``specific limit'' for
each of the CAA section 112(c)(6) HAP. It is not clear what the
commenter means by a ``specific limit.'' The commenter may be arguing
that the EPA cannot rely on CAA section 112(d)(2) or (d)(4) standards
that use surrogates to demonstrate that it has satisfied its obligation
under CAA section 112(c)(6). However, it appears that the commenter is
arguing that CAA section 112(c)(6) somehow limits the EPA's discretion
to use particular types of surrogates when setting MACT standards. The
commenter specifically objects to the EPA's standard for total HAP or
total hazardous organic pollutants. There is no statutory support for
either argument. Indeed, as other sections of the CAA illustrate,
Congress knew how to require pollutant-specific standards. For example,
CAA section 129(a)(4) explicitly requires the EPA to set numeric
standards ``for the [enumerated] substances or mixtures'' listed in
that subsection. That provision expressly requires the EPA to set
numerical emissions limitations ``for'' a list of nine substances
emitted by solid waste incineration units, and expressly authorizes the
regulation of other pollutants through, among other things, surrogate
standards. Unlike CAA section 129(a)(4), the terms of CAA section
112(c)(6) do not direct the EPA to set such standards ``for'' the CAA
section 112(c)(6) HAP. Congress conspicuously did not take this
approach in CAA section 112(c)(6), and, thus, left intact the EPA's
discretion to establish surrogate standards.
    CAA section 112(c)(6) requires the Agency to assure that ``sources
accounting for'' at least 90 percent of the emissions of the listed HAP
are ``subject to standards'' under CAA sections 112(d)(2) or (d)(4),
without specifying the form of those standards, or how those standards
must operate or be applied to those sources. The provision does not
expressly state that the EPA can meet CAA section 112(c)(6) only by
setting specific standards ``for'' the listed HAP, unlike CAA section
129(a)(4). As the commenter notes, the United States Court of Appeals
for the District of Columbia Circuit upheld the

EPA's approach of satisfying its general obligation under CAA section
112 to set standards through surrogates, as long as the choice of the
surrogate is itself reasonable. National Lime Ass'n v. EPA, 233 F.3d
625, 634, 637 (D.C. Cir. 2000); see also, e.g., Sierra Club v. EPA, 353
F.3d 976, 982-85 (D.C. Cir. 2004). In fact, in the National Lime
decision, instead of mandating that the EPA set a specific standard for
each metallic HAP, the Court held that the EPA's standards for PM as a
surrogate for regulating the aggregate metallic HAP was reasonable. 233
F.3d at 639.
    Moreover, CAA section 112(c)(6) contains a numeric benchmark only
as to source categories responsible for the percentage of aggregate
baseline emissions that must be controlled, not the amount of emissions
of each enumerated HAP that must be reduced. As this Court explained in
National Lime, where ``EPA is under no obligation to achieve a
particular numerical reduction in HAP . . . emissions,'' but rather
only to apply MACT based on the HAP reductions ``achieved'' by certain
facilities, ``then the EPA may require . . . control [of a surrogate]
without quantifying the reduction in [the target] HAP . . . thus
achieved.'' 233 F.3d at 639. The same rationale applies here, where the
EPA's only obligation under CAA section 112(c)(6) is to apply the same
MACT standard considered in National Lime to particular sources
accounting for 90 percent of emissions of the CAA section 112(c)(6)
HAP. The EPA has set standards pursuant to CAA sections 112(d)(2) or
(d)(4) regulating emissions of substances identified as surrogates for
the CAA section 112(c)(6) HAP, and those standards reduce the CAA
section 112(c)(6) HAP; thus, the EPA has fully met its obligation to
set standards assuring that source categories accounting for not less
than 90 percent of the aggregate emissions of the CAA section 112(c)(6)
pollutants at issue are subject to section 112(d)(2) or (4) standards.
    The commenter also contends that the present determination
constitutes a separate CAA 307(d) rulemaking with regard to many of the
previously and elsewhere promulgated surrogate standards that the EPA
credits towards satisfying the requirement in CAA section 112(c)(6)
that source categories accounting for 90 percent of the aggregate
enumerated HAP be subjected to CAA section 112(d)(2) or (4) standards.
The commenter argues that the EPA must demonstrate anew the validity of
the prior separate rulemaking actions and provide data and
documentation to support specific aspects of those rules to satisfy the
general rulemaking requirements of CAA section 307(d) and the
requirements of CAA section 112. There is no statutory basis for this
argument, which is an attempt to use this non-statutorily required
determination that the EPA has satisfied its CAA section 112(c)(6)
obligation to reopen numerous rules, many of which were finalized over
a decade ago, as a means to force a non-required re-opening of such
standards. Moreover, the commenter's assertion that the proposed CAA
section 112(c)(6) determination was the first time the EPA provided
notice of its claim that the surrogate standards were being credited
for controlling the CAA section 112(c)(6) HAP is inaccurate, assuming
it is even relevant (nothing in section 112(c)(6), after all, requires
EPA to ``provide notice,'' either sequentially or ultimately, that the
Agency has finally discharged its duty to set section 112(d)(2)
standards for the subject source categories accounting for 90 percent
of the aggregate section 112(c)(6) HAP. In any event, contrary to the
commenter's assertion, the EPA provided such notice of its expectations
to discharge its section 112(c)(6) responsibilities when the Agency
published the 1998 listing notice identifying the source categories
that, based on the 1990 emissions inventory, are responsible for 90
percent of the aggregate emissions of each of the seven pollutants
identified in section 112(c)(6) from stationary, anthropogenic sources
(i.e., sources within the scope of CAA sections 112 and/or 129).\8\ 63
FR 17838 (April 10, 1998) (``1998 listing notice''). Included on the
list were the MACT standards for the source categories at issue in this
comment, and most of the specific standards in the comments were
promulgated prior to the 1998 listing. The commenter's argument that
the proposed determination constitutes the first time notice was given
is without merit for any source category listed in the 1998 notice,
particularly for those source categories that were regulated after that
listing was published in the Federal Register. The argument is also
without merit for the standards issued prior to the 1998 notice. While
the EPA might not have identified at the time some of these standards
were issued that the EPA would count the standards towards meeting the
90 percent requirement in CAA section 112(c)(6), such intent was made
public in the 1998 notice. Further, as discussed above, the public was
on notice at the time the EPA established these MACT standards that the
standards would regulate the HAP, including the CAA section 112(c)(6)
HAP, emitted from the source categories. If the commenter believed that
the prior actions did not sufficiently control the HAP, including the
CAA section 112(c)(6) HAP, from those source categories, the commenter
had a responsibility to make those assertions at the time the Agency
established the CAA section 112(d) standards. This applied equally to
the comments questioning the surrogate standards. The commenter should
have raised its concerns with the surrogate standards for ``total HAP''
or ``total organic HAP'' at the time the standards were issued if it
believed such surrogates are not reasonable or in compliance with the
CAA. In any event, the commenter's claim that the proposed
determination was the first time notice is refuted by the
administrative petitions the commenter filed in 1999, subsequent to the
1998 notice, requesting the EPA to revise some of the standards
included in the 1998 notice and addressed in the comments on the
proposed CAA section 112(c)(6) determination at issue. In a letter
dated January 19, 2001, the EPA denied the petitions, explaining how
each of these standards meet the CAA section 112(c)(6) requirement in
addressing the HAP enumerated in that section.\9\
---------------------------------------------------------------------------

    \8\ The EPA has updated the 1998 listing several times to remove
source categories no longer needed to meet the CAA section 112(c)(6)
requirement based on updated information, and to add source
categories subsequently determined to be necessary to reach the 90
percent threshold. See, e.g., 76 FR 9450 (February 17, 2011) (adding
Gold Mine source category); 73 FR 1916 (January 10, 2008)
(finalizing decision not to regulate gasoline distribution area
sources under CAA section 112(c)(6)); 72 FR 53814 (September 20,
2007) (adding Electric Arc Furnace Steelmaking Facility area source
category); 67 FR 68124 (November 8, 2002) (removing several source
categories).
    \9\ Letter from Browner to Pew, Response to Sierra Club Petition
to Revise Regulations for the SOCMI Category, Coke Oven Batteries,
Petroleum Refineries, Medical Waste Incinerators, and Municipal
Waste Combustors (dated January 25, 1999)(January 19, 2001).
---------------------------------------------------------------------------

    Section 112(c)(6) does not require that the EPA take an additional,
separate final regulatory action to re-open any previously promulgated
standards, and the EPA in fact did not reopen these prior actions in
the proposed CAA section 112(c)(6) determination. Therefore, the
proposed notice does not support a belated, backdoor attack on rules
that were in some cases issued more than 20 years ago. The proposed CAA
section 112(c)(6) determination is a simple, discretionary accounting
of the EPA's previous regulatory efforts, explaining in mathematical
terms that the EPA has previously listed sources

and promulgated HAP standards sufficient to satisfy the requirement
that sources needed for meeting the 90 percent requirement for each of
the CAA section 112(c)(6) HAP have, in fact, become subject to
standards under CAA sections 112(d)(2) or (4). While the proposed
determination in some instances clarifies the surrogacy relationship
between the established standards and the relevant CAA section
112(c)(6) HAP, the proposal does not discuss or attest to the substance
of the standards previously promulgated for each listed category and
subcategory because those standards have been subject to their own
notice and comment rulemaking processes, and, in several cases, to
judicial review as provided by the strict statute of limitations
imposed by CAA section 307(b)(1). The proposed determination only
provides the mathematical and technical basis for the EPA's calculation
that the sources in the categories and subcategories for which it has
separately promulgated emission standards account for 90 percent of the
baseline emissions of the CAA section 112(c)(6) HAP.
    The United States Court of Appeals for the District of Columbia
Circuit specified in Oljato Chapter of Navajo Tribe v. Train, 515 F.2d
654, 666 (D.C. Cir. 1975), a procedure for pursuing claims that new
information merits revision of a previous agency regulation: The
prospective petitioner must first bring the new information to the
Agency's attention in an administrative petition seeking revision of
the prior regulation. CAA Section 553(d) of the Administrative
Procedure Act (APA) also explicitly allows parties to petition the
Agency to amend a rule. A party that identifies new information that it
believes undermines the legitimacy of an existing standard may, at any
time, petition the Agency to review and revise that standard. Any party
that believed an existing MACT standard was deficient because it failed
to adequately address one or more HAP emitted by the source category
could have submitted a petition asking the EPA to consider the new
information and amend the existing rule to cure any alleged deficiency.
    In addition, as discussed above, the 1998 listing notice provided
sufficient notice that the EPA intended to rely on previously issued
MACT standards to satisfy the CAA section 112(c)(6) requirement, to the
extent that the public did not recognize that it was already on notice
regarding the MACT standards' applicability to all HAP emitted by the
source categories at the time those standards were issued. If the
commenter believed one or more of the standards listed in that 1998
notice did not adequately address the CAA section 112(c)(6) HAP, it
should have filed an administrative petition making the argument that
the 1998 notice constituted new information concerning the substance of
those previously issued standards and asked the EPA to amend the
original rules that established the MACT standards. In fact, as stated
above, the commenter filed an administrative petition on several of the
rules addressed in its comments and did not challenge the EPA's denial
of that 2001 petition. Assuming arguendo that the 1998 notice provided
an opportunity to challenge the previously issued MACT standards, any
such challenge is now time barred because the commenter should have
brought the challenge to those rules within 6 years of the 1998 notice,
wherein the EPA included those source categories in the CAA section
112(c)(6) inventory. See 28 U.S.C. 2401(a) (requiring civil actions
against the United States to be brought within 6 years after the right
of action first accrues). For source categories included in but
regulated after the 1998 listing, the commenter was on notice and
should have commented directly on surrogacy and other issues at the
time the standards were promulgated, even if the EPA did not reiterate
in the rulemaking record that the EPA was counting those sources'
standards toward the 90 percent requirement.
    The commenter's main concern appears to be the EPA's use of ``total
HAP'' or ``total organic HAP'' as surrogates for certain CAA section
112(c)(6) HAP. The commenter claims such approach is unlawful under the
plain language of CAA section 112(c)(6) because according to the
commenter that provision requires the EPA to set a MACT standard
``for'' ``each section 112(c)(6) HAP.'' In support, the commenter cites
a United States Court of Appeals for the District of Columbia Circuit
opinion in a case reviewing the NESHAP for the Gold Mine Ore Processing
and Production area source category (``the Gold Mine area source
rule''). See Desert Citizens Against Pollution v. EPA, 699 F.3d 524
(D.C. Cir. 2012). As explained above, the commenter's interpretation of
CAA section 112(c)(6) to require a specific MACT standard for ``each
section 112(c)(6) HAP'' is unsupported by the plain text of the
statute. Unlike CAA section 129(a)(4), the terms of CAA section
112(c)(6) do not direct the EPA to set such standards ``for'' the
section 112(c)(6) HAP. Further, nothing in the United States Court of
Appeals for the District of Columbia Circuit opinion or the Gold Mine
area source rule referenced in the comment addresses the issue of
surrogacy. This is not surprising considering that rule directly
regulates mercury, the only CAA section 112(c)(6) HAP emitted from the
Gold Mine area sources. The relevant issue in that case was whether the
EPA must also set CAA section 112(d)(2) standards for all of the non-
CAA section 112(c)(6) HAP emitted by the Gold Mine area sources. The
Court upheld the EPA's interpretation that CAA section 112(c)(6) does
not impose such requirement on non-CAA section 112(c)(6) HAP emitted
from area sources just because they emit one or more CAA section
112(c)(6) HAP (in this case, just mercury). The commenter also suggests
that its claim is supported by the EPA's own interpretation, but does
not cite or reference any specific EPA statement. In any event,
interpretations and statements the EPA made in support of the Gold Mine
area source rule were specific to those area sources and should not be
taken out of context.
    To the extent the commenter is claiming that a surrogate cannot be
a group of HAP (e.g., total organic HAP or total HAP), the commenter's
interpretation of CAA section 112(c)(6) contradicts the United States
Court of Appeals for the District of Columbia Circuit's decision in
National Lime, 233 F.3d at 639. In that decision, the Court held that
PM, which is itself comprised of a group of pollutants, is a reasonable
surrogate for metallic HAP, see National Lime, 233 F.3d at 639. Neither
PM nor metallic HAP is a single HAP; each has various pollutants as
constituents. As the Court holds, the EPA may set surrogate standards
for HAP where it is reasonable to do so, see National Lime, 233 F.3d at
637. Therefore, a surrogate can be one or multiple pollutants as long
as it is reasonable, and the reasonableness of the use of a surrogate
can be properly challenged only at the time the standards are
promulgated.
    For the reasons stated above, the EPA is not required in this
action to re-evaluate previously promulgated MACT standards and respond
to the belated comments on the substance of these standards, as the
commenter claims. Congress deliberately promoted the value of finality
of the EPA's standards in requiring parties to challenge rules within
60 days of promulgation under CAA section 307(b)(1), and in precluding
opportunities to randomly challenge standards in post-promulgation fora
such as civil or criminal enforcement proceedings. See CAA section
307(b)(2). Moreover, nothing in CAA section 112(c)(6) serves as an
exception to this emphasis on

finality and regulatory repose, given that CAA section 112(c)(6) itself
does not require the EPA to issue any final notice or take any other
final action that functions to re-open previously promulgated standards
that are credited to meeting the 90 percent requirement. If, in fact,
additional control of HAP, including CAA section 112(c)(6) HAP, is
appropriate because of remaining risk or newly available control
technologies or practices, the CAA addresses that possibility by
requiring review of CAA section 112(d)(2) standards pursuant to CAA
sections 112(d)(6) and (f)(2). Thus, the commenter has had and will
have additional opportunities to address whether additional control of
the section 112(c)(6) HAP is warranted.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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

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

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because it does not contain any information collection
activities.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This action
does not alter any of the standards discussed in this document.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

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

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

    This action does not have tribal implications, as specified in
Executive Order 13175. This action does not materially alter the
stringency of any standards discussed in this document. Thus, Executive
Order 13175 does not apply to this action.

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. A
health and risk assessment was not performed for this action because it
does not alter any of the regulations discussed in this action.

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

    This rulemaking does not involve technical standards.

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

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low income
or indigenous populations because it does not affect the level of
protection provided to human health or the environment. An
environmental justice evaluation was not performed for this action
because it does not alter any of the regulations discussed in this
action.

K. Congressional Review Act (CRA)

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

    Dated: May 22, 2015.
Gina McCarthy,
Administrator.
[FR Doc. 2015-13500 Filed 6-2-15; 8:45 am]
 BILLING CODE 6560-50-P