82 FR 22888 - Air Quality Designations for the 2012 Primary Annual Fine Particle (PM2.5

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 96 (May 19, 2017)

Page Range		22888-22893
FR Document		2017-10245
The Environmental Protection Agency (EPA) is establishing air quality designations in the United States (U.S.) for the 2012 primary annual fine particle (PM<INF>2.5</INF>) National Ambient Air Quality Standard (NAAQS) for the remaining undesignated areas in the state of Tennessee. When the EPA designated the majority of areas in the country in December 2014, and March 2015, the EPA deferred initial area designations for several locations, including all of the state of Tennessee except three counties in the Chattanooga area, because the EPA could not determine using available data whether the areas were meeting or not meeting the NAAQS. However, we believed that forthcoming data in 2015 would allow the EPA to make that determination. Tennessee has now submitted complete, quality-assured, and certified air quality monitoring data for 2015 for the areas identified in this document, and based on these data, the EPA is designating these areas as unclassifiable/attainment for the 2012 primary annual PM<INF>2.5</INF> NAAQS.
Federal Register, Volume 82 Issue 96 (Friday, May 19, 2017)
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Rules and Regulations]
[Pages 22888-22893]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10245]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-HQ-OAR-2012-0918; FRL-9962-89-OAR]
RIN 2060-AT44


Air Quality Designations for the 2012 Primary Annual Fine 
Particle (PM2.5) National Ambient Air Quality Standard (NAAQS) for 
Areas in Tennessee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is establishing air 
quality designations in the United States (U.S.)

[[Page 22889]]

for the 2012 primary annual fine particle (PM2.5) National 
Ambient Air Quality Standard (NAAQS) for the remaining undesignated 
areas in the state of Tennessee. When the EPA designated the majority 
of areas in the country in December 2014, and March 2015, the EPA 
deferred initial area designations for several locations, including all 
of the state of Tennessee except three counties in the Chattanooga 
area, because the EPA could not determine using available data whether 
the areas were meeting or not meeting the NAAQS. However, we believed 
that forthcoming data in 2015 would allow the EPA to make that 
determination. Tennessee has now submitted complete, quality-assured, 
and certified air quality monitoring data for 2015 for the areas 
identified in this document, and based on these data, the EPA is 
designating these areas as unclassifiable/attainment for the 2012 
primary annual PM2.5 NAAQS.

DATES: This final rule is effective on June 19, 2017.

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OAR-2012-0918. All documents in the docket are 
listed in the https://www.regulations.gov index. Although listed in the 
index, some information is not publicly available, i.e., Confidential 
Business Information or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in https://www.regulations.gov or in 
hard copy at the EPA Docket Center, William Jefferson Clinton West 
Building, Room 3334, 1301 Constitution Avenue 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 (202) 566-1744 and the telephone number for the Air 
Docket is (202) 566-1742.
    In addition, the EPA has established a Web site for the rulemakings 
to initially designate areas for the 2012 primary annual 
PM2.5 NAAQS at: https://www3.epa.gov/pmdesignations/2012standards/index.htm. This Web site includes the EPA's final 
PM2.5 designations, as well as state and tribal initial 
recommendation letters, the EPA's modification letters, technical 
support documents, responses to comments and other related technical 
information.

FOR FURTHER INFORMATION CONTACT: For general questions concerning this 
action, please contact Carla Oldham, U.S. EPA, Office of Air Quality 
Planning and Standards, Air Quality Planning Division, C539-04, 
Research Triangle Park, North Carolina 27711, telephone (919) 541-3347, 
email at [email protected]. The Region 4 contact is Madolyn Sanchez, 
U.S. EPA, Air Regulatory Management Section, Air Planning and 
Implementation Branch, Air, Pesticides and Toxics Management Division, 
61 Forsyth Street SW., Atlanta, Georgia 30303-8960, telephone (404) 
562-9644, email at [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 14, 2012, the EPA promulgated a revised primary annual 
PM2.5 NAAQS to provide increased protection of public health 
from fine particle pollution (78 FR 3086; January 15, 2013). In that 
action, the EPA strengthened the primary annual PM2.5 
standard from 15.0 micrograms per cubic meter ([mu]g/m\3\) to 12.0 
[mu]g/m\3\, which is attained when the 3-year average of the annual 
arithmetic means does not exceed 12.0 [mu]g/m\3\. Section 107(d) of the 
Clean Air Act (CAA), 42 U.S.C. 7407(d), governs the process for initial 
area designations after the EPA establishes a new or revised NAAQS. 
Under CAA section 107(d), each governor is required to, and each tribal 
leader may, if they so choose, recommend air quality designations to 
the EPA by a date that cannot be later than 1 year after the 
promulgation of a new or revised NAAQS. The EPA considers these 
recommendations as part of its duty to promulgate the area designations 
and boundaries for the new or revised NAAQS. If, after careful 
consideration of these recommendations, the EPA believes that it is 
necessary to modify a state's recommendation and intends to promulgate 
a designation different from a state's recommendation, the EPA must 
notify the state at least 120 days prior to promulgating the final 
designation and the EPA must provide the state an opportunity to 
demonstrate why any proposed modification is inappropriate. These 
modifications may relate either to an area's designation or to its 
boundaries.
    On December 18, 2014, the Administrator of the EPA signed a final 
action promulgating initial designations for the 2012 primary 
PM2.5 NAAQS based on 2011-2013-air quality monitoring data 
for the majority of the U.S., including areas of Indian country (80 FR 
2206; January 15, 2015). In that action, the EPA also deferred initial 
area designations for several areas where available data, including air 
quality monitoring data, were insufficient to determine whether the 
areas met or did not meet the NAAQS, but where forthcoming data were 
likely to result in complete and valid air quality data sufficient to 
determine whether these areas meet the NAAQS. Accordingly, the EPA 
stated that it would use the additional time available as provided 
under section 107(d)(1)(B) of the CAA to assess relevant information 
and subsequently promulgate initial designations for the identified 
areas through a separate rulemaking action or actions. The deferred 
areas included the entire state of Tennessee, except three counties in 
the Chattanooga area; several areas in the state of Georgia, including 
two neighboring counties in the bordering states of Alabama and South 
Carolina; the entire state of Florida; and areas of Indian country 
located in these areas.
    In separate actions published on April 15, 2015 (80 FR 18535), and 
September 6, 2016 (81 FR 61136), the EPA completed designations of 
unclassifiable/attainment for all remaining deferred areas in the state 
of Georgia (including two neighboring counties in the bordering states 
of Alabama and South Carolina) and 62 counties in the state of Florida, 
including areas of Indian country located in those areas.

II. Purpose and Designation Decisions Based on 2013-2015 Data

    The purpose of this action is to announce and promulgate initial 
area designations of unclassifiable/attainment for the 2012 
PM2.5 NAAQS for the remaining 92 counties in the state of 
Tennessee.\1\ All of the areas at issue in this action were initially 
deferred in the EPA's January 15, 2015, rulemaking.\2\ Since then, the 
state of Tennessee submitted to the EPA complete, quality-assured, and 
certified air quality monitoring data from 2013-2015 for these deferred 
areas. These data provide the EPA with sufficient information to 
promulgate initial designations for the remaining undesignated areas in 
the state of Tennessee in this action. Air quality data collected and 
submitted to the EPA

[[Page 22890]]

for 2013-2015 for these areas indicate that the areas are attaining the 
2012 PM2.5 NAAQS and are not causing or contributing to a 
violation of the NAAQS in a nearby area. Therefore, the EPA is 
designating the remaining 92 undesignated counties in the state of 
Tennessee as unclassifiable/attainment. This designation is consistent 
with Tennessee's recommended area designations and boundaries for these 
areas for the 2012 PM2.5 standard. The table at the end of 
this final rule (amendments to 40 CFR 81.343--Tennessee) lists all 
areas for which the EPA has promulgated an initial designation in 
Tennessee. There are no areas of Indian country covered by this action.
---------------------------------------------------------------------------

    \1\ The 3 previously designated unclassifiable/attainment 
counties in the Chattanooga area are Hamilton County, Marion County 
and Sequatchie County.
    \2\ See also the technical support document for the deferred 
Tennessee areas in the rulemaking docket, document numbered EPA-HQ-
OAR-2012-0918-0325.
---------------------------------------------------------------------------

III. Environmental Justice Considerations

    When the EPA establishes a new or revised NAAQS, the CAA requires 
the EPA to designate all areas of the U.S. as either nonattainment, 
attainment, or unclassifiable. The EPA provided a meaningful 
opportunity for members of the public to participate in the development 
of the 2012 primary annual PM2.5 standard that underlies the 
present action, including conducting an outreach and information call 
with environmental justice organizations on August 9, 2012.
    As part of the process of reviewing the PM air quality criteria and 
revising the primary annual PM2.5 standard, the EPA 
identified persons from lower socioeconomic strata as an at-risk 
population for PM-related health effects. As a result, the EPA 
carefully evaluated the potential impacts on low-income and minority 
populations. Based on this evaluation and consideration of public 
comments, the EPA eliminated spatial averaging provisions as part of 
the form of the primary annual PM2.5 standard in order to 
avoid potential disproportionate impacts on at-risk populations, 
including populations from lower socioeconomics strata. See 78 FR at 
3267 (January 15, 2013).
    This final action addresses designation determinations for certain 
areas in Tennessee based on that 2012 primary annual PM2.5 
standard. The CAA requires the EPA to determine through a designation 
process whether an area meets or does not meet any new or revised 
national primary or secondary ambient air quality standard. The 
promulgation of area designations facilitates public understanding and 
awareness of the air quality in an area. For this action, the complete 
and valid monitoring data from Tennessee indicate that all affected 
areas are meeting the NAAQS. Furthermore, no area affected by this 
action is contributing to a NAAQS violation in a nearby area.

IV. Statutory and Executive Order Reviews

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

    This action is exempt from review by the Office of Management and 
Budget because it responds to the CAA requirement to promulgate air 
quality designations after promulgation of a new or revised NAAQS.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under 
the PRA. This action fulfills the non-discretionary duty for the EPA to 
promulgate air quality designations after promulgation of a new or 
revised NAAQS and does not contain any information collection 
activities.

C. Regulatory Flexibility Act (RFA)

    This designation action under CAA section 107(d) is not subject to 
the RFA. The RFA applies only to rules subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act (APA), 5 
U.S.C. 553, or any other statute. Section 107(d)(2)(B) of the CAA 
explicitly provides that designations are exempt from the notice and 
comment provisions of the APA. In addition, designations under section 
107(d) are not among the list of actions that are subject to the notice 
and comment procedures of CAA section 307(d).

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 implements mandates specifically and 
explicitly set forth in the CAA for the 2012 PM2.5 NAAQS (40 
CFR 50.18). The CAA establishes the process whereby states take primary 
responsibility for developing plans, where required, to meet the 2012 
PM2.5 NAAQS.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
a 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 Government

    This action does not have tribal implications. It will neither 
impose substantial direct compliance costs on federally recognized 
tribal governments, nor preempt tribal law. Areas of Indian country are 
not being designated as part of this action.

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

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

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

    The EPA believes that this action does not have disproportionately 
high and adverse human health or environmental effects on minority 
populations, low-income populations and/or indigenous peoples, as 
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The 
documentation for this determination is contained in Section III of 
this preamble, ``Environmental Justice Considerations.''

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 U.S. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

L. Judicial Review

    Section 307(b)(1) of the CAA indicates which Federal Courts of 
Appeal have venue for petitions of review of final

[[Page 22891]]

actions by the EPA. This section provides, in part, that petitions for 
review must be filed in the Court of Appeals for the District of 
Columbia Circuit: (i) When the agency action consists of ``nationally 
applicable regulations promulgated, or final actions taken by the 
Administrator,'' or (ii) when such action is locally or regionally 
applicable, if ``such action is based on a determination of nationwide 
scope or effect and if in taking such action the Administrator finds 
and publishes that such action is based on such a determination.''
    This final action, in conjunction with the previous final actions 
designating areas across the U.S. for the 2012 annual PM2.5 
NAAQS, is ``nationally applicable'' within the meaning of section 
307(b)(1). At the core of this final action is the EPA's 
interpretations of the definitions of nonattainment, attainment and 
unclassifiable under section 107(d)(1) of the CAA, and its application 
of those interpretations to areas across the country. For the same 
reasons, the Administrator is also determining that the final 
designations are of nationwide scope and effect for the purposes of 
section 307(b)(1). This is particularly appropriate because, in the 
report on the 1977 Amendments that revised section 307(b)(1) of the 
CAA, Congress noted that the Administrator's determination that an 
action is of ``nationwide scope or effect'' would be appropriate for 
any action that has a scope or effect beyond a single judicial circuit. 
H.R. Rep. No. 95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-
03. Here, the scope and effect of this final action extends to numerous 
judicial circuits since the designations relate to the designations for 
areas across the country. In these circumstances, section 307(b)(1) and 
its legislative history calls for the Administrator to find the action 
to be of ``nationwide scope or effect'' and for venue to be in the D.C. 
Circuit.
    Thus, any petitions for review of final designations must be filed 
in the Court of Appeals for the District of Columbia Circuit within 60 
days from the date final action is published in the Federal Register.

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks, 
Wilderness areas.

    Dated: May 10, 2017.
E. Scott Pruitt,
Administrator.
    For the reasons set forth in the preamble, 40 CFR part 81 is 
amended as follows:

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for part 81 continues to read as follows:

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

Subpart C--Section 107 Attainment Status Designations

0
2. Section 81.343 is amended by revising the table entitled 
``Tennessee--2012 Annual PM2.5 NAAQS [Primary]'' to read as 
follows:


Sec.  81.343  Tennessee.

* * * * *

                                       Tennessee--2012 Annual PM2.5 NAAQS
                                                    [Primary]
----------------------------------------------------------------------------------------------------------------
                                            Designation                             Classification
     Designated area \1\      ----------------------------------------------------------------------------------
                                     Date \2\              Type             Date \2\                Type
----------------------------------------------------------------------------------------------------------------
Statewide:
    Anderson County..........  ....................  Unclassifiable/
                                                      Attainment.
    Bedford County...........  ....................  Unclassifiable/
                                                      Attainment.
    Benton County............  ....................  Unclassifiable/
                                                      Attainment.
    Bledsoe County...........  ....................  Unclassifiable/
                                                      Attainment.
    Blount County............  ....................  Unclassifiable/
                                                      Attainment.
    Bradley County...........  ....................  Unclassifiable/
                                                      Attainment.
    Campbell County..........  ....................  Unclassifiable/
                                                      Attainment.
    Cannon County............  ....................  Unclassifiable/
                                                      Attainment.
    Carroll County...........  ....................  Unclassifiable/
                                                      Attainment.
    Carter County............  ....................  Unclassifiable/
                                                      Attainment.
    Cheatham County..........  ....................  Unclassifiable/
                                                      Attainment.
    Chester County...........  ....................  Unclassifiable/
                                                      Attainment.
    Claiborne County.........  ....................  Unclassifiable/
                                                      Attainment.
    Clay County..............  ....................  Unclassifiable/
                                                      Attainment.
    Cocke County.............  ....................  Unclassifiable/
                                                      Attainment.
    Coffee County............  ....................  Unclassifiable/
                                                      Attainment.
    Crockett County..........  ....................  Unclassifiable/
                                                      Attainment.
    Cumberland County........  ....................  Unclassifiable/
                                                      Attainment.
    Davidson County..........  ....................  Unclassifiable/
                                                      Attainment.
    Decatur County...........  ....................  Unclassifiable/
                                                      Attainment.
    DeKalb County............  ....................  Unclassifiable/
                                                      Attainment.
    Dickson County...........  ....................  Unclassifiable/
                                                      Attainment.
    Dyer County..............  ....................  Unclassifiable/
                                                      Attainment.
    Fayette County...........  ....................  Unclassifiable/
                                                      Attainment.
    Fentress County..........  ....................  Unclassifiable/
                                                      Attainment.
    Franklin County..........  ....................  Unclassifiable/
                                                      Attainment.
    Gibson County............  ....................  Unclassifiable/
                                                      Attainment.
    Giles County.............  ....................  Unclassifiable/
                                                      Attainment.
    Grainger County..........  ....................  Unclassifiable/
                                                      Attainment.
    Greene County............  ....................  Unclassifiable/
                                                      Attainment.
    Grundy County............  ....................  Unclassifiable/
                                                      Attainment.
    Hamblen County...........  ....................  Unclassifiable/
                                                      Attainment.
    Hamilton County..........  April 15, 2015......  Unclassifiable/
                                                      Attainment.
    Hancock County...........  ....................  Unclassifiable/
                                                      Attainment.

[[Page 22892]]

 
    Hardeman County..........  ....................  Unclassifiable/
                                                      Attainment.
    Hardin County............  ....................  Unclassifiable/
                                                      Attainment.
    Hawkins County...........  ....................  Unclassifiable/
                                                      Attainment.
    Haywood County...........  ....................  Unclassifiable/
                                                      Attainment.
    Henderson County.........  ....................  Unclassifiable/
                                                      Attainment.
    Henry County.............  ....................  Unclassifiable/
                                                      Attainment.
    Hickman County...........  ....................  Unclassifiable/
                                                      Attainment.
    Houston County...........  ....................  Unclassifiable/
                                                      Attainment.
    Humphreys County.........  ....................  Unclassifiable/
                                                      Attainment.
    Jackson County...........  ....................  Unclassifiable/
                                                      Attainment.
    Jefferson County.........  ....................  Unclassifiable/
                                                      Attainment.
    Johnson County...........  ....................  Unclassifiable/
                                                      Attainment.
    Knox County..............  ....................  Unclassifiable/
                                                      Attainment.
    Lake County..............  ....................  Unclassifiable/
                                                      Attainment.
    Lauderdale County........  ....................  Unclassifiable/
                                                      Attainment.
    Lawrence County..........  ....................  Unclassifiable/
                                                      Attainment.
    Lewis County.............  ....................  Unclassifiable/
                                                      Attainment.
    Lincoln County...........  ....................  Unclassifiable/
                                                      Attainment.
    Loudon County............  ....................  Unclassifiable/
                                                      Attainment.
    McMinn County............  ....................  Unclassifiable/
                                                      Attainment.
    McNairy County...........  ....................  Unclassifiable/
                                                      Attainment.
    Macon County.............  ....................  Unclassifiable/
                                                      Attainment.
    Madison County...........  ....................  Unclassifiable/
                                                      Attainment.
    Marion County............  April 15, 2015......  Unclassifiable/
                                                      Attainment.
    Marshall County..........  ....................  Unclassifiable/
                                                      Attainment.
    Maury County.............  ....................  Unclassifiable/
                                                      Attainment.
    Meigs County.............  ....................  Unclassifiable/
                                                      Attainment.
    Monroe County............  ....................  Unclassifiable/
                                                      Attainment.
    Montgomery County........  ....................  Unclassifiable/
                                                      Attainment.
    Moore County.............  ....................  Unclassifiable/
                                                      Attainment.
    Morgan County............  ....................  Unclassifiable/
                                                      Attainment.
    Obion County.............  ....................  Unclassifiable/
                                                      Attainment.
    Overton County...........  ....................  Unclassifiable/
                                                      Attainment.
    Perry County.............  ....................  Unclassifiable/
                                                      Attainment.
    Pickett County...........  ....................  Unclassifiable/
                                                      Attainment.
    Polk County..............  ....................  Unclassifiable/
                                                      Attainment.
    Putnam County............  ....................  Unclassifiable/
                                                      Attainment.
    Rhea County..............  ....................  Unclassifiable/
                                                      Attainment.
    Roane County.............  ....................  Unclassifiable/
                                                      Attainment.
    Robertson County.........  ....................  Unclassifiable/
                                                      Attainment.
    Rutherford County........  ....................  Unclassifiable/
                                                      Attainment.
    Scott County.............  ....................  Unclassifiable/
                                                      Attainment.
    Sequatchie County........  April 15, 2015......  Unclassifiable/
                                                      Attainment.
    Sevier County............  ....................  Unclassifiable/
                                                      Attainment.
    Shelby County............  ....................  Unclassifiable/
                                                      Attainment.
    Smith County.............  ....................  Unclassifiable/
                                                      Attainment.
    Stewart County...........  ....................  Unclassifiable/
                                                      Attainment.
    Sullivan County..........  ....................  Unclassifiable/
                                                      Attainment.
    Sumner County............  ....................  Unclassifiable/
                                                      Attainment.
    Tipton County............  ....................  Unclassifiable/
                                                      Attainment.
    Trousdale County.........  ....................  Unclassifiable/
                                                      Attainment.
    Unicoi County............  ....................  Unclassifiable/
                                                      Attainment.
    Union County.............  ....................  Unclassifiable/
                                                      Attainment.
    Van Buren County.........  ....................  Unclassifiable/
                                                      Attainment.
    Warren County............  ....................  Unclassifiable/
                                                      Attainment.
    Washington County........  ....................  Unclassifiable/
                                                      Attainment.
    Wayne County.............  ....................  Unclassifiable/
                                                      Attainment.
    Weakley County...........  ....................  Unclassifiable/
                                                      Attainment.
    White County.............  ....................  Unclassifiable/
                                                      Attainment.
    Williamson County........  ....................  Unclassifiable/
                                                      Attainment.
    Wilson County............  ....................  Unclassifiable/
                                                      Attainment.
----------------------------------------------------------------------------------------------------------------
\1\ Includes areas of Indian country located in each county or area, if any, except as otherwise specified.
\2\ This date is June 19, 2017, unless otherwise noted.


[[Page 22893]]

* * * * *
[FR Doc. 2017-10245 Filed 5-18-17; 8:45 am]
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transportation or communications satisfactory evidence. For purposes of
Register will determine the effective
services announced under paragraph (a), paragraph (b) of this section, satisfactory
date of receipt on a case-by-case basis.
shall be assigned, as the date of receipt evidence may include:
of the application, fee, deposit, or other (1) A receipt from the United States Dated: May 11, 2017.
material, the date on which the Register Postal Service indicating the date on Karyn Temple Claggett,
determines the material would have which the United States Postal Service Acting Register of Copyrights and Director
been received but for the disruption or received material for delivery to the of the U.S. Copyright Office.
suspension of services, so long as the Copyright Office by means of first class Approved by:
application, fee, deposit, or other mail, Priority Mail, or Express Mail; Carla D. Hayden,
material was actually received in the (2) A receipt from a delivery service
Librarian of Congress.
Copyright Office within one month after such as, or comparable to, United Parcel
the date the Register identifies pursuant Service, Federal Express, or Airborne [FR Doc. 2017–10218 Filed 5–18–17; 8:45 am]
to paragraph (a) of this section that Express, indicating the date on which BILLING CODE 1410–30–P

disruption or suspension of services has the delivery service received material
terminated. Such requests should be for delivery to the Copyright Office; and
mailed to the address specified in (i) The date on which delivery was to ENVIRONMENTAL PROTECTION
§ 201.1(c)(1), or through any other be made to the Copyright Office, or AGENCY
delivery method the Register specifies (ii) The period of time (e.g., overnight,
in a published announcement under or two days) from receipt by the 40 CFR Part 81
paragraph (a) of this section. delivery service to the date on which [EPA–HQ–OAR–2012–0918; FRL–9962–89–
(2) With respect to disruption delivery was to be made to the OAR]
affecting specific submission. In the Copyright Office;
absence of a declaration of disruption (3) A statement under penalty of RIN 2060–AT44
under paragraph (a) of this section, any perjury, pursuant to 28 U.S.C. 1746,
Air Quality Designations for the 2012
person who provides satisfactory from a person with actual knowledge of
Primary Annual Fine Particle (PM2.5)
evidence as described in paragraph (e) the facts relating to the attempt to
National Ambient Air Quality Standard
of this section that he or she physically deliver the material to the Copyright
(NAAQS) for Areas in Tennessee
delivered or attempted to physically Office, setting forth with particularity
deliver an application, fee, deposit, or facts which satisfy the Register that in
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AGENCY: Environmental Protection
other material to the Copyright Office, the absence of the general disruption or Agency (EPA).
but that the Office did not receive that suspension of postal or other ACTION: Final rule.
material or that it was lost or misplaced transportation or communications
by the Office after its delivery to the services, including a disruption or SUMMARY: The Environmental Protection
Office, shall be assigned, as the date of suspension of a Copyright Office Agency (EPA) is establishing air quality
receipt, the date that the Register electronic system, or but for the designations in the United States (U.S.)

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for the 2012 primary annual fine FOR FURTHER INFORMATION CONTACT: For (80 FR 2206; January 15, 2015). In that
particle (PM2.5) National Ambient Air general questions concerning this action, the EPA also deferred initial area
Quality Standard (NAAQS) for the action, please contact Carla Oldham, designations for several areas where
remaining undesignated areas in the U.S. EPA, Office of Air Quality Planning available data, including air quality
state of Tennessee. When the EPA and Standards, Air Quality Planning monitoring data, were insufficient to
designated the majority of areas in the Division, C539–04, Research Triangle determine whether the areas met or did
country in December 2014, and March Park, North Carolina 27711, telephone not meet the NAAQS, but where
2015, the EPA deferred initial area (919) 541–3347, email at oldham.carla@ forthcoming data were likely to result in
designations for several locations, epa.gov. The Region 4 contact is complete and valid air quality data
including all of the state of Tennessee Madolyn Sanchez, U.S. EPA, Air sufficient to determine whether these
except three counties in the Chattanooga Regulatory Management Section, Air areas meet the NAAQS. Accordingly,
area, because the EPA could not Planning and Implementation Branch, the EPA stated that it would use the
determine using available data whether Air, Pesticides and Toxics Management additional time available as provided
the areas were meeting or not meeting Division, 61 Forsyth Street SW., Atlanta, under section 107(d)(1)(B) of the CAA to
the NAAQS. However, we believed that Georgia 30303–8960, telephone (404) assess relevant information and
forthcoming data in 2015 would allow 562–9644, email at sanchez.madolyn@ subsequently promulgate initial
the EPA to make that determination. epa.gov. designations for the identified areas
Tennessee has now submitted complete, through a separate rulemaking action or
SUPPLEMENTARY INFORMATION:
quality-assured, and certified air quality actions. The deferred areas included the
monitoring data for 2015 for the areas I. Background entire state of Tennessee, except three
identified in this document, and based On December 14, 2012, the EPA counties in the Chattanooga area;
on these data, the EPA is designating promulgated a revised primary annual several areas in the state of Georgia,
these areas as unclassifiable/attainment PM2.5 NAAQS to provide increased including two neighboring counties in
for the 2012 primary annual PM2.5 protection of public health from fine the bordering states of Alabama and
NAAQS. particle pollution (78 FR 3086; January South Carolina; the entire state of
15, 2013). In that action, the EPA Florida; and areas of Indian country
DATES: This final rule is effective on located in these areas.
June 19, 2017. strengthened the primary annual PM2.5
In separate actions published on April
standard from 15.0 micrograms per
ADDRESSES: The EPA has established a 15, 2015 (80 FR 18535), and September
cubic meter (mg/m3) to 12.0 mg/m3,
docket for this action under Docket ID 6, 2016 (81 FR 61136), the EPA
which is attained when the 3-year
No. EPA–HQ–OAR–2012–0918. All completed designations of
average of the annual arithmetic means
documents in the docket are listed in unclassifiable/attainment for all
does not exceed 12.0 mg/m3. Section
the https://www.regulations.gov index. remaining deferred areas in the state of
107(d) of the Clean Air Act (CAA), 42
Although listed in the index, some Georgia (including two neighboring
U.S.C. 7407(d), governs the process for
information is not publicly available, counties in the bordering states of
initial area designations after the EPA
i.e., Confidential Business Information Alabama and South Carolina) and 62
establishes a new or revised NAAQS.
or other information whose disclosure is counties in the state of Florida,
Under CAA section 107(d), each
restricted by statute. Certain other including areas of Indian country
governor is required to, and each tribal
material, such as copyrighted material, located in those areas.
leader may, if they so choose,
is not placed on the Internet and will be recommend air quality designations to II. Purpose and Designation Decisions
publicly available only in hard copy the EPA by a date that cannot be later Based on 2013–2015 Data
form. Publicly available docket than 1 year after the promulgation of a The purpose of this action is to
materials are available either new or revised NAAQS. The EPA announce and promulgate initial area
electronically in https:// considers these recommendations as designations of unclassifiable/
www.regulations.gov or in hard copy at part of its duty to promulgate the area attainment for the 2012 PM2.5 NAAQS
the EPA Docket Center, William designations and boundaries for the new
Jefferson Clinton West Building, Room for the remaining 92 counties in the
or revised NAAQS. If, after careful state of Tennessee.1 All of the areas at
3334, 1301 Constitution Avenue NW., consideration of these
Washington, DC. The Public Reading issue in this action were initially
recommendations, the EPA believes that deferred in the EPA’s January 15, 2015,
Room is open from 8:30 a.m. to 4:30 it is necessary to modify a state’s
p.m., Monday through Friday, excluding rulemaking.2 Since then, the state of
recommendation and intends to Tennessee submitted to the EPA
legal holidays. The telephone number promulgate a designation different from
for the Public Reading Room is (202) complete, quality-assured, and certified
a state’s recommendation, the EPA must air quality monitoring data from 2013–
566–1744 and the telephone number for notify the state at least 120 days prior
the Air Docket is (202) 566–1742. 2015 for these deferred areas. These data
to promulgating the final designation provide the EPA with sufficient
In addition, the EPA has established and the EPA must provide the state an information to promulgate initial
a Web site for the rulemakings to opportunity to demonstrate why any designations for the remaining
initially designate areas for the 2012 proposed modification is inappropriate. undesignated areas in the state of
primary annual PM2.5 NAAQS at: These modifications may relate either to Tennessee in this action. Air quality
https://www3.epa.gov/pmdesignations/ an area’s designation or to its data collected and submitted to the EPA
2012standards/index.htm. This Web boundaries.
site includes the EPA’s final PM2.5 On December 18, 2014, the
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1 The 3 previously designated unclassifiable/
designations, as well as state and tribal Administrator of the EPA signed a final attainment counties in the Chattanooga area are
initial recommendation letters, the action promulgating initial designations Hamilton County, Marion County and Sequatchie
EPA’s modification letters, technical for the 2012 primary PM2.5 NAAQS County.
2 See also the technical support document for the
support documents, responses to based on 2011–2013-air quality deferred Tennessee areas in the rulemaking docket,
comments and other related technical monitoring data for the majority of the document numbered EPA–HQ–OAR–2012–0918–
information. U.S., including areas of Indian country 0325.

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22890 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Rules and Regulations

for 2013–2015 for these areas indicate area affected by this action is F. Executive Order 13175: Consultation
that the areas are attaining the 2012 contributing to a NAAQS violation in a and Coordination With Indian Tribal
PM2.5 NAAQS and are not causing or nearby area. Government
contributing to a violation of the This action does not have tribal
IV. Statutory and Executive Order
NAAQS in a nearby area. Therefore, the implications. It will neither impose
Reviews
EPA is designating the remaining 92 substantial direct compliance costs on
undesignated counties in the state of A. Executive Order 12866: Regulatory federally recognized tribal governments,
Tennessee as unclassifiable/attainment. Planning and Review and Executive nor preempt tribal law. Areas of Indian
This designation is consistent with Order 13563: Improving Regulation and country are not being designated as part
Tennessee’s recommended area Regulatory Review of this action.
designations and boundaries for these
This action is exempt from review by G. Executive Order 13045: Protection of
areas for the 2012 PM2.5 standard. The
table at the end of this final rule the Office of Management and Budget Children From Environmental Health
(amendments to 40 CFR 81.343— because it responds to the CAA and Safety Risks
Tennessee) lists all areas for which the requirement to promulgate air quality
designations after promulgation of a The EPA interprets Executive Order
EPA has promulgated an initial 13045 as applying to those regulatory
designation in Tennessee. There are no new or revised NAAQS.
actions that concern environmental
areas of Indian country covered by this B. Paperwork Reduction Act (PRA) health or safety risks that the EPA has
action. reason to believe may
This action does not impose an
III. Environmental Justice information collection burden under the disproportionately affect children, per
Considerations PRA. This action fulfills the non- the definition of ‘‘covered regulatory
discretionary duty for the EPA to action’’ in section 2–202 of the
When the EPA establishes a new or
promulgate air quality designations after Executive Order. This action is not
revised NAAQS, the CAA requires the
promulgation of a new or revised subject to Executive Order 13045
EPA to designate all areas of the U.S. as
NAAQS and does not contain any because it does not establish an
either nonattainment, attainment, or
unclassifiable. The EPA provided a information collection activities. environmental standard intended to
meaningful opportunity for members of mitigate health or safety risks.
C. Regulatory Flexibility Act (RFA)
the public to participate in the H. Executive Order 13211: Actions That
development of the 2012 primary This designation action under CAA Significantly Affect Energy Supply,
annual PM2.5 standard that underlies the section 107(d) is not subject to the RFA. Distribution or Use
present action, including conducting an The RFA applies only to rules subject to
notice and comment rulemaking This action is not subject to Executive
outreach and information call with Order 13211 because it is not a
environmental justice organizations on requirements under the Administrative
Procedure Act (APA), 5 U.S.C. 553, or significant regulatory action under
August 9, 2012. Executive Order 12866.
As part of the process of reviewing the any other statute. Section 107(d)(2)(B) of
PM air quality criteria and revising the the CAA explicitly provides that I. National Technology Transfer and
primary annual PM2.5 standard, the EPA designations are exempt from the notice Advancement Act (NTTAA)
identified persons from lower and comment provisions of the APA. In This rulemaking does not involve
socioeconomic strata as an at-risk addition, designations under section technical standards.
population for PM-related health effects. 107(d) are not among the list of actions
As a result, the EPA carefully evaluated that are subject to the notice and J. Executive Order 12898: Federal
the potential impacts on low-income comment procedures of CAA section Actions To Address Environmental
and minority populations. Based on this 307(d). Justice in Minority Populations and
evaluation and consideration of public Low-Income Population
D. Unfunded Mandates Reform Act
comments, the EPA eliminated spatial The EPA believes that this action does
(UMRA)
averaging provisions as part of the form not have disproportionately high and
of the primary annual PM2.5 standard in This action does not contain any adverse human health or environmental
order to avoid potential unfunded mandate as described in effects on minority populations, low-
disproportionate impacts on at-risk UMRA, 2 U.S.C. 1531–1538 and does income populations and/or indigenous
populations, including populations not significantly or uniquely affect small peoples, as specified in Executive Order
from lower socioeconomics strata. See governments. The action implements 12898 (59 FR 7629, February 16, 1994).
78 FR at 3267 (January 15, 2013). mandates specifically and explicitly set The documentation for this
This final action addresses forth in the CAA for the 2012 PM2.5 determination is contained in Section III
designation determinations for certain NAAQS (40 CFR 50.18). The CAA of this preamble, ‘‘Environmental
areas in Tennessee based on that 2012 establishes the process whereby states Justice Considerations.’’
primary annual PM2.5 standard. The take primary responsibility for
CAA requires the EPA to determine developing plans, where required, to K. Congressional Review Act (CRA)
through a designation process whether meet the 2012 PM2.5 NAAQS. This action is subject to the CRA, and
an area meets or does not meet any new the EPA will submit a rule report to
or revised national primary or E. Executive Order 13132: Federalism
each House of the Congress and to the
secondary ambient air quality standard. This action does not have federalism Comptroller General of the U.S. This
The promulgation of area designations implications. It will not have a
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action is not a ‘‘major rule’’ as defined
facilitates public understanding and substantial direct effects on the states, by 5 U.S.C. 804(2).
awareness of the air quality in an area. on the relationship between the national
For this action, the complete and valid government and the states, or on the L. Judicial Review
monitoring data from Tennessee distribution of power and Section 307(b)(1) of the CAA indicates
indicate that all affected areas are responsibilities among the various which Federal Courts of Appeal have
meeting the NAAQS. Furthermore, no levels of government. venue for petitions of review of final

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actions by the EPA. This section the purposes of section 307(b)(1). This List of Subjects in 40 CFR Part 81
provides, in part, that petitions for is particularly appropriate because, in Environmental protection, Air
review must be filed in the Court of the report on the 1977 Amendments that pollution control, National parks,
Appeals for the District of Columbia revised section 307(b)(1) of the CAA, Wilderness areas.
Circuit: (i) When the agency action Congress noted that the Administrator’s
consists of ‘‘nationally applicable Dated: May 10, 2017.
determination that an action is of
regulations promulgated, or final actions E. Scott Pruitt,
‘‘nationwide scope or effect’’ would be
taken by the Administrator,’’ or (ii) appropriate for any action that has a Administrator.
when such action is locally or regionally scope or effect beyond a single judicial For the reasons set forth in the
applicable, if ‘‘such action is based on preamble, 40 CFR part 81 is amended as
circuit. H.R. Rep. No. 95–294 at 323,
a determination of nationwide scope or follows:
324, reprinted in 1977 U.S.C.C.A.N.
effect and if in taking such action the
Administrator finds and publishes that 1402–03. Here, the scope and effect of
this final action extends to numerous PART 81—DESIGNATION OF AREAS
such action is based on such a FOR AIR QUALITY PLANNING
determination.’’ judicial circuits since the designations
relate to the designations for areas PURPOSES
This final action, in conjunction with
the previous final actions designating across the country. In these ■ 1. The authority citation for part 81
areas across the U.S. for the 2012 annual circumstances, section 307(b)(1) and its continues to read as follows:
PM2.5 NAAQS, is ‘‘nationally legislative history calls for the
Administrator to find the action to be of Authority: 42 U.S.C. 7401, et seq.
applicable’’ within the meaning of
section 307(b)(1). At the core of this ‘‘nationwide scope or effect’’ and for Subpart C—Section 107 Attainment
final action is the EPA’s interpretations venue to be in the D.C. Circuit. Status Designations
of the definitions of nonattainment, Thus, any petitions for review of final
attainment and unclassifiable under designations must be filed in the Court ■ 2. Section 81.343 is amended by
section 107(d)(1) of the CAA, and its revising the table entitled ‘‘Tennessee—
of Appeals for the District of Columbia
application of those interpretations to 2012 Annual PM2.5 NAAQS [Primary]’’
Circuit within 60 days from the date
areas across the country. For the same to read as follows:
reasons, the Administrator is also final action is published in the Federal
determining that the final designations Register. § 81.343 Tennessee.
are of nationwide scope and effect for * * * * *

TENNESSEE—2012 ANNUAL PM2.5 NAAQS
[Primary]

Designation Classification
Designated area 1
Date 2 Type Date 2 Type

Statewide:
Anderson County ................................ ........................... Unclassifiable/Attainment.
Bedford County ................................... ........................... Unclassifiable/Attainment.
Benton County .................................... ........................... Unclassifiable/Attainment.
Bledsoe County ................................... ........................... Unclassifiable/Attainment.
Blount County ..................................... ........................... Unclassifiable/Attainment.
Bradley County ................................... ........................... Unclassifiable/Attainment.
Campbell County ................................ ........................... Unclassifiable/Attainment.
Cannon County ................................... ........................... Unclassifiable/Attainment.
Carroll County ..................................... ........................... Unclassifiable/Attainment.
Carter County ...................................... ........................... Unclassifiable/Attainment.
Cheatham County ............................... ........................... Unclassifiable/Attainment.
Chester County ................................... ........................... Unclassifiable/Attainment.
Claiborne County ................................ ........................... Unclassifiable/Attainment.
Clay County ........................................ ........................... Unclassifiable/Attainment.
Cocke County ..................................... ........................... Unclassifiable/Attainment.
Coffee County ..................................... ........................... Unclassifiable/Attainment.
Crockett County .................................. ........................... Unclassifiable/Attainment.
Cumberland County ............................ ........................... Unclassifiable/Attainment.
Davidson County ................................. ........................... Unclassifiable/Attainment.
Decatur County ................................... ........................... Unclassifiable/Attainment.
DeKalb County .................................... ........................... Unclassifiable/Attainment.
Dickson County ................................... ........................... Unclassifiable/Attainment.
Dyer County ........................................ ........................... Unclassifiable/Attainment.
Fayette County .................................... ........................... Unclassifiable/Attainment.
Fentress County .................................. ........................... Unclassifiable/Attainment.
Franklin County ................................... ........................... Unclassifiable/Attainment.
Gibson County .................................... ........................... Unclassifiable/Attainment.
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Giles County ....................................... ........................... Unclassifiable/Attainment.
Grainger County .................................. ........................... Unclassifiable/Attainment.
Greene County .................................... ........................... Unclassifiable/Attainment.
Grundy County .................................... ........................... Unclassifiable/Attainment.
Hamblen County ................................. ........................... Unclassifiable/Attainment.
Hamilton County ................................. April 15, 2015 ... Unclassifiable/Attainment.
Hancock County .................................. ........................... Unclassifiable/Attainment.

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TENNESSEE—2012 ANNUAL PM2.5 NAAQS—Continued
[Primary]

Designation Classification
Designated area 1
Date 2 Type Date 2 Type

Hardeman County ............................... ........................... Unclassifiable/Attainment.
Hardin County ..................................... ........................... Unclassifiable/Attainment.
Hawkins County .................................. ........................... Unclassifiable/Attainment.
Haywood County ................................. ........................... Unclassifiable/Attainment.
Henderson County .............................. ........................... Unclassifiable/Attainment.
Henry County ...................................... ........................... Unclassifiable/Attainment.
Hickman County .................................. ........................... Unclassifiable/Attainment.
Houston County .................................. ........................... Unclassifiable/Attainment.
Humphreys County ............................. ........................... Unclassifiable/Attainment.
Jackson County .................................. ........................... Unclassifiable/Attainment.
Jefferson County ................................. ........................... Unclassifiable/Attainment.
Johnson County .................................. ........................... Unclassifiable/Attainment.
Knox County ....................................... ........................... Unclassifiable/Attainment.
Lake County ........................................ ........................... Unclassifiable/Attainment.
Lauderdale County .............................. ........................... Unclassifiable/Attainment.
Lawrence County ................................ ........................... Unclassifiable/Attainment.
Lewis County ...................................... ........................... Unclassifiable/Attainment.
Lincoln County .................................... ........................... Unclassifiable/Attainment.
Loudon County .................................... ........................... Unclassifiable/Attainment.
McMinn County ................................... ........................... Unclassifiable/Attainment.
McNairy County .................................. ........................... Unclassifiable/Attainment.
Macon County ..................................... ........................... Unclassifiable/Attainment.
Madison County .................................. ........................... Unclassifiable/Attainment.
Marion County ..................................... April 15, 2015 ... Unclassifiable/Attainment.
Marshall County .................................. ........................... Unclassifiable/Attainment.
Maury County ...................................... ........................... Unclassifiable/Attainment.
Meigs County ...................................... ........................... Unclassifiable/Attainment.
Monroe County ................................... ........................... Unclassifiable/Attainment.
Montgomery County ............................ ........................... Unclassifiable/Attainment.
Moore County ..................................... ........................... Unclassifiable/Attainment.
Morgan County ................................... ........................... Unclassifiable/Attainment.
Obion County ...................................... ........................... Unclassifiable/Attainment.
Overton County ................................... ........................... Unclassifiable/Attainment.
Perry County ....................................... ........................... Unclassifiable/Attainment.
Pickett County ..................................... ........................... Unclassifiable/Attainment.
Polk County ......................................... ........................... Unclassifiable/Attainment.
Putnam County ................................... ........................... Unclassifiable/Attainment.
Rhea County ....................................... ........................... Unclassifiable/Attainment.
Roane County ..................................... ........................... Unclassifiable/Attainment.
Robertson County ............................... ........................... Unclassifiable/Attainment.
Rutherford County ............................... ........................... Unclassifiable/Attainment.
Scott County ....................................... ........................... Unclassifiable/Attainment.
Sequatchie County .............................. April 15, 2015 ... Unclassifiable/Attainment.
Sevier County ..................................... ........................... Unclassifiable/Attainment.
Shelby County ..................................... ........................... Unclassifiable/Attainment.
Smith County ...................................... ........................... Unclassifiable/Attainment.
Stewart County ................................... ........................... Unclassifiable/Attainment.
Sullivan County ................................... ........................... Unclassifiable/Attainment.
Sumner County ................................... ........................... Unclassifiable/Attainment.
Tipton County ...................................... ........................... Unclassifiable/Attainment.
Trousdale County ................................ ........................... Unclassifiable/Attainment.
Unicoi County ...................................... ........................... Unclassifiable/Attainment.
Union County ...................................... ........................... Unclassifiable/Attainment.
Van Buren County .............................. ........................... Unclassifiable/Attainment.
Warren County .................................... ........................... Unclassifiable/Attainment.
Washington County ............................. ........................... Unclassifiable/Attainment.
Wayne County .................................... ........................... Unclassifiable/Attainment.
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Weakley County .................................. ........................... Unclassifiable/Attainment.
White County ...................................... ........................... Unclassifiable/Attainment.
Williamson County .............................. ........................... Unclassifiable/Attainment.
Wilson County ..................................... ........................... Unclassifiable/Attainment.
1 Includes areas of Indian country located in each county or area, if any, except as otherwise specified.
2 This date is June 19, 2017, unless otherwise noted.

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Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Rules and Regulations 22893

* * * * * Manufacturer Civil Monetary Penalties’’ final rule (82 FR 14332, (March 20,
[FR Doc. 2017–10245 Filed 5–18–17; 8:45 am] (75 FR 57230, (September 20, 2010)). 2017)) to delay the effective date of the
BILLING CODE 6560–50–P HHS subsequently published a notice of final rule to May 22, 2017, and solicited
proposed rulemaking (NPRM) in June additional comment on whether that
2015 to implement civil monetary date should be further delayed to
DEPARTMENT OF HEALTH AND penalties (CMPs) for manufacturers who October 1, 2017. HHS received a
HUMAN SERVICES knowingly and intentionally charge a number of comments on the interim
covered entity more than the ceiling final rule both supporting and opposing
42 CFR Part 10 price for a covered outpatient drug; to the delay of the effective date to May 22,
provide clarity regarding the 2017, or alternatively to October 1,
RIN 0906–AA89
requirement that manufacturers 2017. After careful consideration of the
340B Drug Pricing Program Ceiling calculate the 340B ceiling price on a comments received, HHS has decided to
Price and Manufacturer Civil Monetary quarterly basis; and to establish the delay the effective date of the January 5,
Penalties Regulation requirement that a manufacturer charge 2017 final rule to October 1, 2017. As
a $.01 (penny pricing policy) for drugs the effective date of the final rule has
AGENCY: Health Resources and Services when the ceiling price calculation been changed to October 1, 2017,
Administration, HHS. equals zero (80 FR 34583, (June 17, enforcement will be correspondingly
ACTION: Final rule; further delay of 2015)). The public comment period delayed to October 1, 2017. HHS
effective date. closed August 17, 2015, and HRSA continues to believe that the delay of the
received 35 comments. After review of effective date provides regulated entities
SUMMARY: The Health Resources and the initial comments, HHS reopened the sufficient time to implement the
Services Administration (HRSA) comment period (81 FR 22960, (April requirements of the rule.
administers section 340B of the Public 19, 2016)) to invite additional comments Section 553(d) of the Administrative
Health Service Act (PHSA), referred to on the following areas of the NPRM: Procedure Act (APA) (5 U.S.C. 551 et
as the ‘‘340B Drug Pricing Program’’ or 340B ceiling price calculations that seq.) requires that Federal agencies
the ‘‘340B Program.’’ HRSA published a result in a ceiling price that equals zero provide at least 30 days after
final rule on January 5, 2017, that set (penny pricing); the methodology that publication of a final rule in the Federal
forth the calculation of the ceiling price manufacturers use when estimating the Register before making it effective,
and application of civil monetary ceiling price for a new covered unless good cause can be found not to
penalties. The final rule applied to all outpatient drug; and the definition of do so. HHS finds that there is good
drug manufacturers that are required to the ‘‘knowing and intentional’’ standard cause for making this final rule effective
make their drugs available to covered to be applied when assessing a CMP for less than 30 days after publication in the
entities under the 340B Program. In manufacturers that overcharge a covered Federal Register given that failure to do
accordance with a January 20, 2017, entity. The comment period closed May so would result in the final rule
memorandum from the Assistant to the 19, 2016, and HHS received 72 published on January 5, 2017, going into
President and Chief of Staff, entitled comments. effect for several weeks, before having a
‘‘Regulatory Freeze Pending Review,’’ On January 5, 2017, HHS published a delayed effective date of October 1,
HRSA issued an interim final rule that final rule in the Federal Register (82 FR 2017. To preclude this uncertainty in
delayed the effective date of the final 1210, (January 5, 2017)) and comments the marketplace and to ease the burdens
rule published in the Federal Register from both the NPRM and the reopening on all stakeholders, HHS believes that a
(82 FR 1210, (January 5, 2017)) to May notice were considered in the clear effective date is an important goal
22, 2017. HHS invited commenters to development of the final rule. The and one that becomes particularly
provide their views on whether a longer provisions of that rule were to be important when it is paired with
delay of the effective date to October 1, effective March 6, 2017; however, HHS potential civil monetary penalties. The
2017, would be more appropriate. After issued a subsequent final rule (82 FR additional time provided to the public
consideration of the comments received 12508, (March 6, 2017)) delaying the before the rule takes effect constitutes
on the interim final rule, HHS is effective date to March 21, 2017, in an extra quarter and will assist
delaying the effective date of the accordance with a January 20, 2017 stakeholders in preparing to comply
January 5, 2017 final rule, to October 1, memorandum from the Assistant to the with these new program requirements.
2017. President and Chief of Staff, entitled II. Analysis and Responses to Public
DATES: As of May 19, 2017, the effective ‘‘Regulatory Freeze Pending Review.’’ 1 Comments
date of the final rule published in the In the January 5, 2017 final rule, HHS
In the interim final rule, we solicited
Federal Register (82 FR 1210, (January recognized that the effective date fell
comments regarding whether HHS
5, 2017)) is further delayed to October during the middle of a quarter and
should delay the January 5, 2017 final
1, 2017. stakeholders needed time to adjust
rule to May 22, 2017, or alternatively to
FOR FURTHER INFORMATION CONTACT: systems and update their policies and
October 1, 2017. We received a broad
CAPT Krista Pedley, Director, Office of procedures. As such, HHS stated that it
range of 51 comments from covered
Pharmacy Affairs, Healthcare Systems intended to enforce the requirements of
entities, manufacturers, and groups
Bureau, HRSA, 5600 Fishers Lane, Mail the final rule at the start of the next
representing these stakeholders. In this
Stop 08W05A, Rockville, MD 20857, or quarter, which began April 1, 2017.
final rule, we will only be responding to
After further consideration and to
by telephone at 301–594–4353. comments related to whether HHS
provide affected parties sufficient time
should delay the January 5, 2017 final
nlaroche on DSK30NT082PROD with RULES

SUPPLEMENTARY INFORMATION: to make needed changes to facilitate
rule to May 22, 2017, or to October 1,
I. Background compliance, and because there were
2017. Comments that raised issues
questions raised, HHS issued an interim
In September 2010, HHS published an beyond the narrow scope of the interim
advanced notice of proposed 1 See: https://www.whitehouse.gov/the-press- final rule, including comments related
rulemaking (ANPRM) in the Federal office/2017/01/20/memorandum-heads-executive- to withdrawal of the rule or comments
Register, ‘‘340B Drug Pricing Program departments-and-agencies. related to policy matters, were not

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This final rule is effective on June 19, 2017.
Contact		For general questions concerning this action, please contact Carla Oldham, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Planning Division, C539-04, Research Triangle Park, North Carolina 27711, telephone (919) 541-3347, email at [email protected] The Region 4 contact is Madolyn Sanchez, U.S. EPA, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960, telephone (404) 562-9644, email at [email protected]
FR Citation		82 FR 22888
RIN Number		2060-AT44
CFR Associated		Environmental Protection; Air Pollution Control; National Parks and Wilderness Areas