[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Rules and Regulations]
[Pages 7974-7976]
[FR Doc No: 2016-03224]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-1096]
RIN 1625-AA00

Safety Zone; Navy UNDET, Apra Outer Harbor, GU

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
underwater detonation operations in the waters of Apra Outer Harbor in
Piti, Guam. This rule is effective from 10 a.m. until 4 p.m. on
February 19, 2016. The Coast Guard believes this safety zone regulation
is necessary to protect all persons and vessels that would otherwise
transit or be within the affected area from possible safety hazards
associated with underwater detonation operations. Entry of vessels or
persons into this zone is prohibited unless specifically authorized by
the Captain of the Port Guam.

DATES: This rule is effective from 10 a.m. through 4 p.m. on February
19, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2015-1096 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Kristina Gauthier, Sector Guam, U.S. Coast Guard;
(671) 355-4866<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
UNDET Underwater detonation
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to public interest. The Coast Guard received notice of this
operation on December 10, 2015, only 71 days before the operation is
scheduled. As a result, the Coast Guard did not have time to issue a
notice of proposed rulemaking. It is impracticable to publish an NPRM
because we must establish this safety zone by February 19, 2016.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register. Due to the late notice
and inherent danger in underwater exercises, delaying the effective
period of this safety zone would be contrary to the public interest.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Guam (COTP) has determined that potential
hazards associated with the U.S. Navy training exercise which include
detonation of underwater explosives on February 19, 2016 will be a
safety concern for anyone within a 700-yard radius on the surface and
1400-yard radius underwater of the operation. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone during the exercise. Mariners and divers
approaching too close to such exercises could potentially expose the
mariner to flying debris or other hazardous conditions.

IV. Discussion of the Rule

    This rule establishes a safety zone from 10 a.m. through 4 p.m. on
February 19, 2016. The safety zone will cover all navigable waters
within 700 yards on the surface and 1400 yards underwater of vessels
and machinery being used by Navy. The duration of the zone is intended
to protect personnel, vessels, and the marine environment in these
navigable waters during the underwater detonation exercise. No vessel
or person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders (E.O.s) related to rulemaking. Below we summarize our
analyses based on a number of these statutes and E.O.s, and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, it has not been
reviewed by the Office of Management and Budget.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. Vessel traffic will be able
to safely transit around this safety zone which will impact a small
designated area of Apra Outer Harbor in Piti, GU, for 6 hours.
Moreover, the Coast Guard will issue Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone and the rule allows vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section A
above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this rule does not have tribal implications under E.O. 13175,
Consultation and Coordination with Indian Tribal Governments, because
it does not have a substantial direct effect on one or more Indian
tribes, on the

relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes. If you believe this rule has implications
for federalism or Indian tribes, please contact the person listed in
the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone lasting 6 hours that will prohibit entry
within 700 yards on the surface and 1400 underwater of vessels and
machinery being used by Navy personnel. It is categorically excluded
from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191, 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T14-1096 to read as follows:

Sec.  165. T14-1096   Safety Zone; Navy UNDET, Apra Outer Harbor, GU.

    (a) Location. The following areas, within the Guam Captain of the
Port (COTP) Zone (See 33 CFR 3.70-15), from the surface of the water to
the ocean floor, are safety zones:
    (1) Seven-hundred-yard-radius-zone. All surface waters bounded by a
circle with a 700-yard radius centered at 13 degrees 27 minutes 42
seconds North Latitude and 144 degrees 38 minutes 30 seconds East
Longitude, (NAD 1983).
    (2) Fourteen-hundred-yard-radius-zone. All underwater areas bounded
by a circle with a 1400 yard radius centered at 13 degrees 27 minutes
42 seconds North Latitude and 144 degrees 38 minutes 30 seconds East
Longitude, (NAD 1983).
    (b) Effective period. This section is effective from 10 a.m.
through 4 p.m. on February 19, 2016.
    (c) Regulations. The general regulations governing safety zones
contained in 33 CFR 165.23 apply. No vessels may enter or transit
safety zone (a)(1) and no persons in the water may enter or transit
safety zone (a)(2) unless authorized by the COTP or a designated
representative thereof.
    (d) Enforcement. Any Coast Guard commissioned, warrant, or petty
officer, and any other COTP representative permitted by law, may
enforce these temporary safety zones.
    (e) Waiver. The COTP may waive any of the requirements of this
section for any person, vessel, or class of vessel upon finding that
application of the safety zone is unnecessary or impractical for the
purpose of maritime security.
    (f) Penalties. Vessels or persons violating this rule are subject
to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: January 27, 2016.
James B. Pruett,
Captain, U.S. Coast Guard, Captain of the Port, Guam.
[FR Doc. 2016-03224 Filed 2-16-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Rules and Regulations]
[Pages 5700-5703]
[FR Doc No: 2012-2598]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2011-0346, FRL-9627-8]

Approval and Promulgation of Implementation Plans; New Hampshire:
Prevention of Significant Deterioration; Greenhouse Gas Permitting
Authority and Tailoring Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving revisions to the New Hampshire State
Implementation Plan (SIP), submitted by the New Hampshire Department of
Environmental Services (NH DES) to EPA on February 7, 2011. The SIP
revision modifies New Hampshire's Prevention of Significant
Deterioration (PSD) program to establish appropriate emission
thresholds for determining which new stationary sources and
modification projects become subject to New Hampshire's PSD permitting
requirements for their greenhouse gas (GHG) emissions. EPA proposed
approval of these regulatory revisions on June 14, 2011, and received
no comments. This action affects major stationary sources in New
Hampshire that have GHG emissions above the thresholds established in
the PSD regulations.

DATES: Effective Date: This rule will be effective on March 7, 2012.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-

2011-0346. All documents in the docket are listed on the http://www.regulations.gov web site. 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 through http://www.regulations.gov or in hard copy at
the U.S. Environmental Protection Agency, EPA New England Regional
Office, Office of Ecosystem Protection, Air Permits, Toxics, and Indoor
Programs Unit, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that if at all possible, you contact the person listed in the
FOR FURTHER INFORMATION CONTACT section for further information. The
Regional Office's official hours of business are Monday through Friday,
8:30 to 4:30, excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: For information regarding the New
Hampshire SIP, contact Donald Dahl, U.S. Environmental Protection
Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Permits, Toxics, and Indoor Programs Unit, 5 Post
Office Square--Suite 100, (mail code OEP05-2), Boston, MA 02109--3912.
Mr. Dahl's telephone number is<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. What is the background for this action?
II. What comments did EPA receive?
III. What is the effect of this action?
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

I. What is the background for this action?

    EPA has recently undertaken a series of actions pertaining to the
regulation of GHGs that, although for the most part distinct from one
another, establish the overall framework for today's final action on
the New Hampshire SIP. Four of these actions include, as they are
commonly called, the ``Endangerment Finding'' and ``Cause or Contribute
Finding,'' which EPA issued in a single final action,\1\ the ``Johnson
Memo Reconsideration,'' \2\ the ``Light-Duty Vehicle Rule,'' \3\ and
the ``Tailoring Rule.'' \4\ Taken together and in conjunction with the
Clean Air Act (CAA), these actions established regulatory requirements
for GHGs emitted from new motor vehicles and new motor vehicle engines;
determined that such regulations, when they took effect on January 2,
2011, subjected GHGs emitted from stationary sources to PSD
requirements; and limited the applicability of PSD requirements to GHG
sources on a phased-in basis.
---------------------------------------------------------------------------

    \1\ ``Endangerment and Cause or Contribute Findings for
Greenhouse Gases Under Section 202(a) of the Clean Air Act.'' 74 FR
66496 (December 15, 2009).
    \2\ ``Interpretation of Regulations that Determine Pollutants
Covered by Clean Air Act Permitting Programs.'' 75 FR 17004 (April
2, 2010).
    \3\ ``Light-Duty Vehicle Greenhouse Gas Emission Standards and
Corporate Average Fuel Economy Standards; Final Rule.'' 75 FR 25324
(May 7, 2010).
    \4\ ``Prevention of Significant Deterioration and Title V
Greenhouse Gas Tailoring Rule; Final Rule.'' 75 FR 31514 (June 3,
2010).
---------------------------------------------------------------------------

    Recognizing that some states had approved SIP PSD programs that do
apply PSD to GHGs, but that do so for sources that emit as little as
100 or 250 tons per year of GHG, and do not limit PSD applicability to
GHGs to the higher thresholds in the Tailoring Rule, EPA published a
final rule on December 30, 2010, narrowing its previous approval of PSD
programs as applicable to GHG-emitting sources in SIPs for 24 states,
including New Hampshire (PSD Narrowing Rule).\5\ In the PSD Narrowing
Rule, EPA withdrew its approval of New Hampshire's SIP, among other
SIPs, to the extent that SIP applies PSD permitting requirements to GHG
emissions from sources emitting at levels below those set in the
Tailoring Rule. Subsequently, New Hampshire's approved SIP provided the
state with authority to regulate GHGs, but only at and above the
Tailoring Rule thresholds; and Federally required new and modified
sources to receive a PSD permit based on GHG emissions only if they
emitted at or above the Tailoring Rule thresholds.
---------------------------------------------------------------------------

    \5\ ``Limitation of Approval of Prevention of Significant
Deterioration Provisions Concerning Greenhouse Gas Emitting-Sources
in State Implementation Plans.'' 75 FR 82536 (December 30, 2010).
---------------------------------------------------------------------------

    On February 7, 2011, in response to the Tailoring Rule and earlier
GHG-related EPA rules, NH DES submitted a revision to EPA for approval
into the New Hampshire SIP to establish appropriate emission thresholds
for determining which new or modified stationary sources become subject
to PSD permitting requirements for GHG emissions. Subsequently, on June
14, 2011 (76 FR 34630), EPA published a proposed approval of this SIP
submittal. Specifically, New Hampshire's February 7, 2011 SIP revision
establishes appropriate emissions thresholds for determining PSD
applicability to new and modified GHG-emitting sources in accordance
with EPA's Tailoring Rule. Detailed background information and EPA's
rationale for the proposed approval are provided in EPA's June 14,
2011, Federal Register action.
    EPA also stated in the proposal that if the Agency did approve New
Hampshire's changes to its air quality regulations to incorporate the
appropriate thresholds for GHG permitting applicability into New
Hampshire's SIP, then Section 52.1522(c) of 40 CFR part 52, as included
in EPA's SIP Narrowing Rule--which codifies EPA's limiting its approval
of New Hampshire's PSD SIP to not cover the applicability of PSD to
GHG-emitting sources below the Tailoring Rule thresholds--is no longer
necessary. Therefore, EPA is amending section 52.1522 of 40 CFR part 52
by removing the unnecessary regulatory language in subsection (c).

II. What comments did EPA receive?

    The public comment period on the proposed approval of New
Hampshire's SIP revision ended on July 14, 2011. EPA did not receive
any comments on the proposed approval of this SIP revision.

III. What is the effect of this action?

    Final approval of New Hampshire's February 2, 2011, SIP revision
incorporates changes to the state's rules to establish the GHG emission
thresholds for PSD applicability set forth in EPA's Tailoring Rule,
confirming that smaller GHG sources emitting less than these thresholds
will not be subject to PSD permitting requirements under the approved
New Hampshire SIP. EPA has determined the SIP revision approved by
today's action is consistent with EPA's regulations, including the
Tailoring Rule. Furthermore, EPA has determined this SIP revision is
consistent with section 110 of the CAA. Pursuant to section 110 of the
CAA, EPA approves this revision into New Hampshire's SIP.
    As a result of today's action approving New Hampshire's
incorporation of the appropriate GHG permitting thresholds into its
SIP, paragraph 40 CFR 52.1522(c), as included in EPA's PSD Narrowing
Rule, is no longer necessary.\6\ Thus, today's action also amends 40
CFR 52.1522 to remove this unnecessary regulatory language.
---------------------------------------------------------------------------

    \6\ 40 CFR 52.1522(c) codifies EPA's limiting its approval of
New Hampshire's PSD SIP to not cover the applicability of PSD to
GHG-emitting sources below the Tailoring Rule thresholds.

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

IV. What action is EPA taking?

    Pursuant to section 110 of the CAA, EPA is approving New
Hampshire's February 7, 2011 SIP revision relating to PSD requirements
for GHG-emitting sources, except for the revised Env-A 619.03(a), which
the state withdrew on May 16, 2011. Our approval includes: A new Env-A
101.35, definition of ``Carbon dioxide equivalent emissions''; a new
Env-A 101.96, definition of ``Greenhouse gases''; an amendment to the
definition of ``Major source'' in Env-A 101.115; and certain amendments
to Env-A 619.03, ``PSD Permit Requirements.''
    Specifically, EPA is approving into the SIP Env-A 619.03(b)-(e) as
revised. However, in place of the state's revisions to Env-A 619.03(a),
the SIP retains the previously-approved provision, which was then
numbered as Env-A 623.03(a).\7\ New Hampshire's previously-approved PSD
regulations became effective under state law on July 23, 2001 and were
approved by EPA on October 28, 2002 (67 FR 65710). EPA and New
Hampshire agree that relying on previously-approved Env-A 623.03(a)
does not affect the manner in which Env-A 619.03(b)-(e) functions. New
Hampshire and EPA may take action on the revision to Env-A 619.03(a) in
the future.
---------------------------------------------------------------------------

    \7\ Env-A 623 was renumbered to Env-A 619 for reasons unrelated
to the Tailoring Rule or this proposed revision.
---------------------------------------------------------------------------

    These revisions establish appropriate emissions thresholds for
determining PSD applicability with respect to new or modified GHG-
emitting stationary sources in accordance with EPA's June 3, 2010,
Tailoring Rule. With this approval, EPA also amends 40 CFR 52.1522 by
removing subsection (c).
    EPA has made the determination this SIP revision is approvable
because it is in accordance with the CAA and EPA regulations regarding
PSD permitting for GHGs. The detailed rationale for this action is set
forth in the proposed rulemaking referenced above, and in this final
rule.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit April 6, 2012. Filing a petition
for reconsideration by the Administrator of this final rule does not
affect the finality of this action for the purposes of judicial review
nor does it extend the time within which a petition for judicial review
may be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

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

    Dated: January 11, 2012.
H. Curtis Spalding,
Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart EE--New Hampshire

0
2. In Sec.  52.1520, the table in paragraph (c) is amended by revising
the entries for Env-A 100 and Env-A 600 to read as follows:

Sec.  52.1520  Identification of plan.

* * * * *
    (c) EPA approved regulations.

                                     EPA Approved New Hampshire Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State effective   EPA approval date
         State citation              Title/subject           date                \1\             Explanations
----------------------------------------------------------------------------------------------------------------
Env-A 100.......................  Organizational             12/21/2010  2/6/2012 [Insert     Added sections
                                   Rules: Definitions.                    Federal Register     101.35, Env-A
                                                                          page number where    101.96, and Env-A
                                                                          the document         101.115.
                                                                          begins].

                                                  * * * * * * *
Env-A 600.......................  Statewide Permit           12/21/2010  2/6/2012 [Insert     Added section Env-
                                   System.                                Federal Register     A 619.03(b)-(e).
                                                                          page number where
                                                                          the document
                                                                          begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

* * * * *

Sec.  52.1522  [Amended]

0
3. Section 52.1522 is amended by removing paragraph (c).

[FR Doc. 2012-2598 Filed 2-3-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2071-2072]
[FR Doc No: 2012-537]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0502, FDA-2011-M-0503, FDA-2011-M-0563, FDA-
2011-M-0564, FDA-2011-M-0600, FDA-2011-M-0601, FDA-2011-M-0630, and
FDA-2011-M-0707]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, (301)
796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from July 1, 2011, through September 30,
2011. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2011, Through
                                               September 30, 2011
----------------------------------------------------------------------------------------------------------------
      PMA No. Docket No.            Applicant                 Trade name                    Approval date
----------------------------------------------------------------------------------------------------------------
P100031, FDA-2011-M-0502......  Roche Diagnostics  ELECSYS ANTI-HBC IMMUNOASSAY &    June 22, 2011.
                                 Corp..             ELECSYS PRECICONTROL ANTI-HBC.
P100032, FDA-2011-M-0503......  Roche Diagnostics  ELECSYS ANTI-HBC IMMUNOASSAY,     June 27, 2011.
                                 Corp..             ELECSYS PRECICONTROL ANTI-HBC
                                                    FOR USE ON THE ELECSYS 2010
                                                    IMMUNOASSAY ANALYZER.
P100001, FDA-2011-M-0563......  Ortho-Clinical     VITROS IMMUNODIAGNOSTICS          July 20, 2011.
                                 Diagnostics,       PRODUCTS ANTI-HBE REAGENT PACK,
                                 Inc..              VITROS IMMUNODIAGNOSTIC
                                                    PRODUCTS ANTI-HBE CALIBRATOR,
                                                    AND VITROS IMMUNODIAGNOSTIC
                                                    PRODUCTS ANTI-HBE CONTROLS.
P110001, FDA-2011-M-0564......  Abbott Vascular..  RX HERCULINK ELITE RENAL STENT    July 20, 2011.
                                                    SYSTEM.
P100044, FDA-2011-M-0600......  Intersect ENT....  PROPEL..........................  August 11, 2011.
P110020, FDA-2011-M-0601......  Roche Molecular    COBAS 4800 BRAF V600 MUTATION     August 17, 2011.
                                 Systems, Inc..     TEST.
P110012, FDA-2011-M-0630......  Abbott Molecular,  VYSIS ALK BREAK APART FISH PROBE  August 26, 2011.
                                 Inc..              KIT; VYSIS PARAFFIN
                                                    PRETREATMENT IV & POST
                                                    HYBRIDIZATION WASH BUFFER KIT;
                                                    PROBECHEK ALK NEGATIVE CONTROL
                                                    SLIDES; AND PROBECHEK ALK
                                                    POSITIVE CONTROL SLIDES.
H100006, FDA-2011-M-0707......  Synapse            NEURX DPS DIAPHRAGM PACING        September 28, 2011.
                                 Biomedical, Inc..  SYSTEM.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.

    Dated: January 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-537 Filed 1-12-12; 8:45 am]
BILLING CODE 4160-01-P


www.erg.com
www.erg.com

MEMORANDUM

TO:	Eric Goehl, Paula Hirtz, Kaye Whitfield, and Kim Teal, U.S. EPA/OAQPS/SPPD

FROM:	Eastern Research Group, Inc.

DATE:	April 22, 2019

SUBJECT:	Documentation for Surface Coating of Metal Can Risk and Technology Review (RTR) Modeling File
--------------------------------------------------------------------------------

INTRODUCTION
The purpose of this memorandum is to provide information on the Environmental Protection Agency (EPA) Risk and Technology Review (RTR) database used in estimating residual risk for the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Surface Coating of Metal Cans (40 CFR part 63, subpart KKKK). This NESHAP covers only Clean Air Act (CAA) section 112 major sources.
Section 112 of the CAA establishes a two-stage regulatory process to address emissions of hazardous air pollutants (HAPs) from stationary sources. In the first stage, section 112(d) requires the EPA to develop maximum achievable control technology (MACT)-based standards for categories of industrial sources. In the second stage, known as the residual risk stage, section 112(f)(2) requires EPA to assess the health and environmental risks that remain after sources come into compliance with the NESHAP based on the MACT. If additional risk reductions are necessary to protect public health with an ample margin of safety or to prevent adverse environmental effects, EPA must develop standards to address these remaining risks. As part of this second stage, data were gathered to assess the residual risks from the surface coating of metal can source category.
FACILITY LIST DEVELOPMENT
The list of facilities potentially subject to the NESHAP for Surface Coating of Metal Cans was initially developed using the Office of Enforcement and Compliance Assurance's (OECA) Enforcement and Compliance History Online (ECHO) database tool.  The Can Manufacturers Institute (CMI) provided excerpts of operating permits for about 40 facilities that were on the original list for the can coating source category to confirm that only five facilities are major sources subject to 40 CFR part 63, subpart KKKK. The list of the five major source facilities is provided in Appendix A.
RECORDS ASSIGNED TO CATEGORY
After the facility list was complete, emissions data were pulled from 2011 NEI v2. The 2014 NEI v1 data were not available at the time the data were originally compiled; the 2011 NEI v2 were the most recent data available at that time. The Source Classification Codes (SCCs) and unit descriptions were reviewed in order to assign records to the metal can surface coating category. The SCCs and unit descriptions were also used to assign Emission Process Groups in the modeling file. The Emission Process Groups are used to understand the relative contribution of each type of process to the overall risk results after modeling is completed.  After assigning records to the category, one facility did not have HAP emissions associated with the metal can surface coating category. The 2014 NEI v1 was available after the original modeling data were compiled and records assigned to the category, and the 2014 NEI v1 contained HAP emissions for metal can surface coating for this facility.  Therefore, the 2014 NEI v1 data were used for one facility.
SPECIATION PROFILES
A complete profile of the HAP emissions from metal can coating for the five major source facilities was available in the 2011 NEI v2 and the 2014 NEI v1, therefore, speciation profiles were not needed for this category.
INDUSTRY REVIEW FILE
      The draft modeling file data were provided to CMI for review in December 2016.  In response, we received revisions for two facilities in May 2017. CMI provided revised emissions estimates for one facility, Miller Coors, located in Golden, CO and revised operating hours (hours per year) for two facilities, Miller Coors, Golden, CO, and Ball Metal Beverage Container Corporation, located in Findlay, OH. The Miller Coors revisions included reduced formaldehyde emissions to reflect controls and reduced operating hours for four can coating lines. The Ball revisions included reduced operating hours for one 2-piece steel food can coating line.
QA OF MODELING FILE DATA
In addition to reviewing the modeling file for completeness of pollutants and emissions data, the stack parameters, fugitive dimensions, and locational coordinates were also reviewed and revised as needed.  This review is discussed in detail in sections 6.1 through 6.3.
STACK PARAMETERS
Stack parameter fields include stack (or fugitive) height, exit gas temperature, stack diameter, exit gas velocity, and exit gas flow rate. ERG used the stack parameter data reported in NEI where possible. Where non-fugitive stack parameters were not populated in NEI, the missing values were calculated. For example, a missing flow rate can be calculated using the reported stack diameter and exit gas velocity.
Fugitive vents are required to have the same five stack parameter fields populated in the modeling file. The stack diameter, exit gas velocity, and exit gas flow rate were populated using national default values of 0.003 ft, 0.0003 ft/sec, and 0 actual cubic ft/sec, respectively.  The fugitive vent release type and the fugitive area release type are both required to have a height and exit gas temperature in the modeling file. There were two fugitive vents in the modeling file, and both had a reported temperature of 72 degrees Fahrenheit in NEI.  Where fugitive height was not provided in NEI, we assigned the national default value of 10 ft.
LOCATIONAL COORDINATES
All latitudes and longitudes were mapped and reviewed using Google Earth. A comment from CMI indicated that coordinates for a facility in Weirton, WV were the midpoint between two contiguous facilities. After review of the permit and historical emissions data, ERG confirmed that there is only one major source facility in this location that is subject to 40 CFR part 63, subpart KKKK. The coordinates were corrected based on Google Earth satellite imagery.
EMISSIONS VALUES
No emission data outliers were identified in the initial EPA TREX screening analysis or the final Human Exposure Model (HEM) risk analysis on the category emissions; therefore, no additional QA or investigation was needed. No emission outliers were identified for other process emissions at the facilities not subject to subpart KKKK (i.e., non-category emissions).
ALLOWABLE EMISSIONS MULTIPLIER
Potential differences between actual emission levels and the maximum emissions allowable under the MACT standard (i.e., "allowable emissions") were calculated for the metal can coating source category. The MACT allowable emissions are the actual emissions multiplied by a factor that represents the difference between the actual emissions, which are based on actual production rates, the HAP content of the coatings and other materials used by the facility, and the coating application method; and the MACT emission limits.
Metal can coating facilities have a variety of coating operations grouped by subcategory, and each subcategory has emission limits, and several compliance options to meet the emission limits. In the NESHAP, metal can coating operations are divided into four subcategories and those subcategories are further divided into coating type segments, each with its own emission limits. Compliance with the emission limits can be achieved using several different options including: a compliant material option, an emission rate without add-on controls option (averaging option), an emission rate with add-on controls option, or a control efficiency/outlet concentration.
To use the compliant material option facilities must demonstrate that the organic HAP content of each coating meets the applicable emission limits and that no organic-HAP containing thinners are used. To use the emission rate without add-on controls option, facilities must demonstrate that the total mass of organic HAP in all coatings and thinners in each coating type segment divided by the total volume of coating solids in that coating type segment meets the applicable emission limit. To use the emission rate with add-on controls option, facilities must determine both the efficiency of the capture system and the emissions reduction efficiency of the control device. If facilities use a solvent recovery system, they may determine the overall control efficiency using a liquid-liquid material balance instead of conducting an initial performance test. To use the control efficiency/outlet concentration option, facilities are required to install a control device parameter monitoring system to demonstrate compliance with the efficiency requirement for add-on control systems (95 percent for existing and 97 percent for new sources), or to install and operate a permanent total enclosure (PTE) with 100-percent emission capture efficiency and comply with a control device organic HAP outlet concentration of 20 ppmvd. All metal can coating facilities using add-on controls to comply with the NESHAP emission limitations must also comply with NESHAP work practices to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, those coating operations.
Our review of facility operating permits confirmed that the five major source facilities subject to this NESHAP employ combinations of compliance options. These include the compliant material option for low-HAP coatings (including UV-cured coatings), emission rate without add-on control (averaging option), and add-on controls with the control efficiency/outlet concentration option. Add-on controls include thermal oxidizers (TOs), regenerative thermal oxidizers (RTOs), and a catalytic oxidizer.
Facilities not using control devices are required to use compliant materials that meet the NESHAP emission rate limits, either individually (compliant material option) or collectively (emission rate without add-on controls option), during each monthly compliance period. Based on the review of the facility operating permits, can coating operations for one of the five facilities use compliant materials and do not require add-on controls, so we assumed the actual emissions for this one facility are equal to the NESHAP allowable emissions.
Based on review of the facility operating permits, when a facility-specific compliance option is listed, the NESHAP control efficiency option (95 percent for existing sources and 97 percent for new sources) is the primary option for these control devices. Further review of the facility operating permits shows that emission reductions for a few of the thermal oxidizers are slightly above the control efficiency level required by the NESHAP (in the range of 97 to 99 percent) which suggests that the actual emissions are slightly lower than the NESHAP allowable level for these control devices. For other control devices, control efficiency data were not available. All facility operating permits contained the NESHAP work practice requirements for the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, those coating operations. Therefore, we assumed the actual emissions are equal to the allowable emissions for those operations. To account for the slightly lower level of actual organic HAP emissions (due to the higher control efficiency of the add-on control devices) we chose to multiply the actual emissions by a factor of 1.1 to represent the allowable emissions from the metal can source category.
ACUTE EMISSIONS MULTIPLIER
As part of the risk assessment analysis, the EPA develops an acute risk estimate that is based on variations in the coating process and the expected highest annual hourly emissions for the source category. We based our estimate on the knowledge we gained about the source category during the RTR review process, site visits, information from can coating facility contacts and the can coating association, and review of facility operating permits.
The can coating industry is mostly a toll industry, where a facility produces cans for many clients. The same basic can coating process is used from facility to facility. The hours of production for each facility are based on customer demand and most run a full 8,760 hours per year. As described above in section 7.0, can coatings are applied in a continuous coating process (not a batch process), resulting in consistent emissions. Therefore, hourly variations in emissions during routine operations are unlikely. We expect there may be slight variations in emissions due to variations in the organic HAP content of the coatings from run to run. To account for this variability, we chose an acute multiplier of 1.1 for the can coating category. Since can coating is a continuous coating process, we don't expect significant changes in hour-to-hour emissions, which is typical of industries with batch operations. The default emission factor of 10 times the annual hourly emission rate is not reasonable for this category. Based on our knowledge of can coating operations we believe that a conservative acute multiplier of 1.1 is appropriate to account for the slight variation in coating composition for this category.

Appendix A  -  Metal Can Coating Modeling File Facility List
                            EIS FACILITY IDENTIFIER
                                 FACILITY NAME
                               LOCATION ADDRESS
                                     CITY
                                  STATE ABBR
                                  COUNTY NAME
1730011
BWAY Corp
3200 S Kilbourn
Chicago
IL
Cook County
536211
BWAY Packaging
1601 Valdosta Highway
Homerville
GA
Clinch County
6235111
BALL METAL FOOD CONTAINER CORP.
3010 BIRCH DRIVE
WEIRTON
WV
Brooke County
8006111
Ball Metal Beverage Container Corporation
12340 Township Road 99
Findlay
OH
Hancock County
894811
MILLERCOORS, LLC - GOLDEN BREWERY
12TH ST AT FORD ST
GOLDEN AREA
CO
Jefferson County