[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2878-2879]
[FR Doc No: 2019-01529]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0449]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Sun Protection Factor
Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
11, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0717.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

SPF Labeling and Testing Requirements for OTC Sunscreen Products--21
CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and (d)

OMB Control Number 0910-0717--Extension

    In the Federal Register of June 17, 2011 (76 FR 35620), we
published a final rule establishing labeling and effectiveness testing
requirements for certain OTC sunscreen products containing specified
active ingredients without approved applications (2011 sunscreen final
rule; Sec.  201.327 (21 CFR 201.327)). In addition to establishing
testing requirements, the 2011 sunscreen final rule lifted the delay of
implementing the prior 1999 sunscreen final rule (published in the
Federal Register of May 21, 1999 (64 FR 27666), and stayed in the
Federal Register of December 31, 2001 (66 FR 67485), from complying
with the 1999 Drug Facts labeling final rule (published in the Federal
Register of March 17, 1999 (64 FR 13254)), in which we amended our
regulations governing requirements for human drug products to establish
standardized format and content requirements for the labeling of all
marketed OTC drug products in part 201 (21 CFR part 201). Specifically,
the 1999 Drug Facts labeling final rule added new Sec.  201.66 (21 CFR
201.66) to part 201. Section 201.66 establishes content and format
requirements for the Drug Facts portion of OTC drug product labels. We
specifically exempted OTC sunscreen products from complying with the
1999 Drug Facts labeling final rule until we lifted the stay of the
1999 sunscreen final rule. The 2011 sunscreen final rule became
effective December 17, 2012, for sunscreen products with annual sales
of $25,000 or more and December 17, 2013, for sunscreen products with
annual sales of less than $25,000 when we published an extension date
notice in the Federal Register of May 11, 2012 (77 FR 27591) (2012
extension date notice).

SPF Labeling and Testing for OTC Sunscreens Containing Specified Active
Ingredients and Marketed Without Approved Applications

    In the Federal Register of June 17, 2011 (76 FR 35678), we
published a 60-day notice requesting public comment on the collection
of information regarding SPF labeling and testing requirements for OTC
sunscreen products containing specified ingredients and marketed
without approved applications (2011 60-day notice). In that notice, we
stated that Sec.  201.327(a)(1) requires the principal display panel
(PDP) labeling of a sunscreen covered by the 2011 sunscreen final rule
to include the SPF value determined by conducting the SPF test outlined
in Sec.  201.327(i). Therefore, that provision resulted in an
information collection with a third-party disclosure burden for
manufacturers of OTC sunscreens covered by the 2011 sunscreen rule. We
determined that products need only complete the testing and labeling
required by the 2011 sunscreen rule once and then continue to use the
resultant labeling (third-party disclosure) going forward without
additional burden. This one-time testing would need to be conducted
within the first 3 years after publication of the 2011 sunscreen final
rule for all OTC sunscreens covered by that rule.
    We determined that the third-party disclosure burden by
manufacturers of OTC sunscreens covered by the 2011 sunscreen rule was
based on: (1) An estimate of the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information;
(2) the conduct of SPF testing based on the estimated number of
existing formulations; (3) an estimate of the time to relabel currently
marketed OTC sunscreens containing specified ingredients and marketed
without approved applications; and (4) testing and labeling of new
products introduced each year. The estimate for this burden in the 2011
60-day notice was a total of 30,066 hours in years one and two and a
total of 966 in each subsequent year.
    All currently marketed OTC sunscreen drug products are already
required to comply with the SPF labeling requirements specified by the
2011 sunscreen final rule. However, our original estimate also included
the burden of new products introduced each year. We estimated that as
many as 60 new OTC sunscreen products stock keeping units (SKUs) may be
introduced each year, which must be tested and labeled with the SPF
value determined in the test. We estimated that the 60 new sunscreen
SKUs represent 39 new formulations. The burden for testing and labeling
these formulations was estimated at 30 hours per year.

Drug Facts Labeling for OTC Sunscreens

    Because the 2011 sunscreen final rule also lifted the delay of
implementing the Drug Facts regulations (Sec.  201.66) for OTC
sunscreens, the rule also modified the information collection
associated with Sec.  201.66 (currently approved under OMB control
number 0910-0340) and added a third-party disclosure burden resulting
from requiring OTC sunscreen products to comply with Drug Facts
regulations. In the 1999 Drug Facts labeling final rule, we amended our
regulations governing requirements for human drug products to establish
standardized format and content requirements for the labeling of all
marketed OTC drug products, codified in Sec.  201.66. This section
establishes requirements for the Drug Facts portion of labels on OTC
drug products requiring such labeling, to include uniform headings and
subheadings,

presented in a standardized order with minimum standards for type size
and other graphical features. Therefore, OTC sunscreen products already
on the market at that time incurred a one-time burden to comply with
the requirements in Sec.  201.66(c) and (d). In the 60-day notice, the
burden was estimated as 43,200 hours for existing sunscreen SKUs and
720 hours for new sunscreen SKUs.
    The compliance dates for the 2011 sunscreen final rule that lifted
the delay of the Sec.  201.66 labeling implementation data for OTC
sunscreen products were December 17, 2012, for sunscreen products with
annual sales of $25,000 or more and December 17, 2013, for sunscreen
products with annual sales of less than $25,000, respectively, when we
published the 2012 extension date notice. All currently marketed
sunscreen products are, therefore, already required to comply with the
Drug Facts labeling requirements in Sec.  201.66 and will incur no
further burden in the 1999 Drug Facts labeling final rule. However, new
OTC sunscreen drug products will be subject to a one-time burden to
comply with Drug Facts labeling requirements in Sec.  201.66. In the
2011 60-day notice, we estimated that as many as 60 new product SKUs
marketed each year must comply with Drug Facts regulations. We
estimated that these 60 SKUs would be marketed by 30 manufacturers,
which will spend approximately 12 hours on each label based on the most
recent estimate used for other OTC drug products to comply with the
1999 Drug Facts labeling final rule, including public comments received
on this estimate in 2010 that addressed sunscreens. This is equal to
720 hours annually (60 SKUs, 12 hours per SKU). We stated that we do
not expect any OTC sunscreens to apply for exemptions or deferrals of
the Drug Facts regulations in Sec.  201.66(e). However, we considered
this in 2013 and estimated the burden for an exemption or deferral by
considering the number of exemptions or deferrals we have received
since publication of the 1999 Drug Facts labeling final rule (one
response) and estimating that a request for deferral or exemption would
require 24 hours to complete. Multiplying the annual frequency of
response (0.125) by the number of hours per response (24) gives a total
response time for requesting an exemption or deferral equal to 3 hours.
    In the Federal Register of August 22, 2018 (83 FR 42509), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                 Table 1--Estimated Annual Third-Party Disclosure Burden
                                                                   [New sunscreens] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conduct SPF testing in accordance with Sec.               20            1.95              39  24........................................             936
  201.327(i) for new sunscreens.
Create PDP labeling in accordance with Sec.               20               3              60  0.5 (30 minutes)..........................              30
  201.327(a)(1) for new sunscreen SKUs.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             966
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                 Table 2--Estimated Annual Third-Party Disclosure Burden
                                                                [Drug facts labeling] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of      disclosures            Total annual disclosures           Average burden    Total hours
                                                respondents   per respondent                                              per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format labeling in accordance with Sec.                   20               3  60........................................              12             720
 201.66(c) and (d) for new sunscreen SKUs.
Request for Drug Facts exemption or deferral               1           0.125  0.125 (7 minutes).........................              24               3
 Sec.   201.66(e).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..........................................  ..............             723
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We note that these estimates may be adjusted in the future as the
result of a detailed analysis of sunscreen market data conducted by FDA
as part of the development of an upcoming proposed rule on OTC
sunscreen products (RIN 0910-AA01). FDA intends to either or both amend
this information collection or seek approval of additional information
collections, as appropriate, concurrent with publication of the
proposed rule.

    Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01529 Filed 2-7-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Proposed Rules]
[Pages 59544-59546]
[FR Doc No: 2016-20667]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9053; Directorate Identifier 2016-NM-075-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
The Boeing Company Model 747-8 and 747-8F series airplanes. This
proposed AD was prompted by reports of damaged vapor seals, block
seals, and heat shield seals on the outboard pylons between the engine
strut and aft fairing. This proposed AD would require repetitive
inspections for heat damage of the vapor seals between the engine strut
and aft fairing, and replacement of the seals with new seals if
necessary. We are proposing this AD to detect and correct heat damage
to the vapor seals between the engine strut and aft fairing. Such
damage could allow flammable fluid leakage into the aft fairing, which
could result in an uncontrolled fire in the engine strut.

DATES: We must receive comments on this proposed AD by October 14,
2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P.O. Box
3707, MC 2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2016-9053.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9053; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sue Lucier, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6438; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2016-9053;
Directorate Identifier 2016-NM-075-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of damaged vapor seals, block seals, and
heat shield seals on the outboard pylons between the aft fairing and
engine strut on the number 1 and number 4 engines. The reports indicate
that vapor seal damage occurring on the outboard pylons at 1,468 flight
cycles, fully compromised the vapor seals at 2,768 flight cycles and
3,626 flight cycles. It was determined that this condition affects only
the outboard pylons because the vapor seal is located directly above
the heat shield seal in these pylons. Heat from the exhaust nozzle to
the vapor seal damages the seal and degrades the sealing quality. The
vapor seal is a safety feature that is designed to isolate flammable
hydraulic fluid from an ignition source. If the vapor seal has heat
damage and there is a hydraulic leak that sprays onto the strut
bulkhead, fluid could drain across the worn seal and contact heat
shield surfaces below the seals. Flammable fluid leakage into the aft
fairing could result in an uncontrolled fire in the engine strut.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 747-54A2246, dated
February 5, 2016. The service information describes procedures for
repetitive inspections for heat damage of the vapor seals between the
engine strut and aft fairing, and replacement of the seals with new
seals. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Difference Between this Proposed AD and the Service
Information.'' For information on the procedures and compliance times,
see this service information at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-9053.

Difference Between This Proposed AD and the Service Information

    Boeing Alert Service Bulletin 747-54A2246, dated February 5, 2016,
recommends accomplishment of Part 4, ``Structural Inspection and Repair
for Heat Damage'' (economic related), during accomplishment of Part 3,
``Seal Replacement'' (safety related), before installation of new
seals. Part 4 is included as an economic consideration to prevent
possible operational

disruptions. However, this NPRM would not require those structural
inspections.

Interim Action

    We consider this proposed AD interim action. The manufacturer is
currently developing a modification that will address the unsafe
condition identified in this proposed AD. Once this modification is
developed, approved, and available, we might consider additional
rulemaking.

Costs of Compliance

    We estimate that this proposed AD affects 10 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Vapor seal inspections.........  4 work-hours X $85 per               $0  $340 per            $3,400 per
                                  hour = $340 per                          inspection cycle.   inspection cycle
                                  inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary seal
replacement that would be required based on the results of the proposed
vapor seal inspection. We have no way of determining the number of
aircraft that might need these seal replacements.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Seal replacement...........................  132 work-hours x $85 per hour =                  $0         $11,220
                                              $11,220.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2016-9053; Directorate Identifier
2016-NM-075-AD.

(a) Comments Due Date

    We must receive comments by October 14, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 747-8 and 747-8F
series airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 54 Nacelles/
pylons.

(e) Unsafe Condition

    This AD was prompted by reports of damaged vapor seals, block
seals, and heat shield seals on the outboard pylons between the
engine strut and aft fairing. We are issuing this AD to detect and
correct heat damage to the vapor seals between the engine strut and
aft fairing. Such damage could allow flammable fluid leakage into
the aft fairing, which could result in an uncontrolled fire in the
engine strut.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    At the later of the times specified in paragraphs (g)(1) and
(g)(2) of this AD: Do a detailed inspection for heat damage of the

vapor seals on the outboard pylons between the strut and aft fairing
of the numbers 1 and 4 engines, in accordance with Part 2 of the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
54A2246, dated February 5, 2016. Repeat the inspection thereafter at
intervals not to exceed 1,200 flight cycles.
    (i) Before the accumulation of 1,800 total flight cycles, or
within 1,800 flight cycles after the most recent vapor seal, block
seal, and heat shield seal replacement, whichever is later.
    (ii) Within 6 months after the effective date of this AD.

(h) Replacement

    If during any inspection required by paragraph (g) of this AD
any heat damage of any vapor seal is found: Before further flight,
replace the vapor seal, heat shield seal, and block seal with new
seals, in accordance with Part 3 of the Accomplishment Instructions
of Boeing Alert Service Bulletin 747-54A2246, dated February 5,
2016. Repeat the inspection required by paragraph (g) of this AD
within 1,800 flight cycles after doing the replacement, and
thereafter at intervals not to exceed 1,200 flight cycles.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(i)(4)(i) and (i)(4)(ii) apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    (1) For more information about this AD, contact Sue Lucier,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle ACO,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 19, 2016.
Dorr M. Anderson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-20667 Filed 8-29-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Rules and Regulations]
[Pages 67317-67319]
[FR Doc No: 2015-27751]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0992]
RIN 1625-AA00

Safety Zone; Grounded Vessel, Atlantic Ocean, Port St. Lucie, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
waters of the Atlantic Ocean, east of the Port St. Lucie Inlet. The
safety zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by a grounded vessel outside
the Port St. Lucie Inlet. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Miami.

DATES: This rule is effective without actual notice from November 2,
2015] until November 15, 2015. For purposes of enforcement, actual
notice will be used from October 27, 2015 through November 2, 2015.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2015-0992 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 Petty Officer Benjamin R. Colbert, Sector Miami Waterways
Management Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<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
U.S.C. United States Code

II. Background Information and Regulatory History

    In the evening of October 26, 2015, the Coast Guard was notified
that a 60 foot motorized vessel was taking on water in the vicinity of
the Port St. Lucie Inlet. Over the next several hours attempts to
refloat the vessel were unsuccessful and the grounded vessel settled on
the bottom. Local, state, and federal agencies are now engaged in
emergency salvage operations.
    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 this rule is being established in
response to an ongoing emergency situation. Delay in publishing this
rule would be impracticable because the grounded vessel poses an
immediate risk public safety. In addition, any delay in the publishing
of this rule would be contrary to public interest. This rule is needed
immediately in order to ensure safety of life on the navigable waters
surrounding this ongoing emergency situation.
    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. For the same reasons
discussed above, delay in issuing this rule would be both impracticable
and contrary to public interest. The rule is in response to an emergent
safety issue and is needed in order to ensure safety of life in the
area around this emergency situation.

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 Miami (COTP) has determined that
potential hazards associated with the grounded vessel will be a safety
concern for anyone within a 100-yard radius of the vessel and equipment
engaged in salvage operations. This rule is needed to protect
personnel, vessels, and the marine environment in the navigable waters
within the safety zone while emergency salvage operations take place.

IV. Discussion of the Rule

    This rule establishes a safety zone from October 27, 2015 through
November 15, 2015. COTP may cease enforcement of the zone if emergency
salvage operations end before November 15, 2015. The safety zone will
cover all navigable waters within 100 yards of vessels and machinery
being used by personnel to conduct emergency salvage operations. The
duration of the zone is intended to protect personnel, vessels, and the
marine environment in these navigable waters while emergency salvage
operations are conducted. 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. Vessel traffic will be able to safely transit
around this safety zone which will impact a small designated area of
the Atlantic Ocean for a limited duration during emergency salvage
operations. 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
V.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 an emergency safety zone implemented to protect persons
and vessels in the vicinity of a grounded vessel. It is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. 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 temporary Sec.  165.T07-0992 to read as follows:

Sec.  165.T07-0992  Safety Zone; Grounded Vessel, Atlantic Ocean; Port
St. Lucie, FL.

    (a) Regulated area. The following regulated area is a safety zone.
All waters of the Atlantic Ocean located east of the Port St. Lucie
Inlet within 100 yards of the grounded vessel located at 27[deg]9'55''
N., 080[deg]10'36'' W. and all vessels and machinery assisting in
emergency salvage operations. All coordinates are North American Datum
1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Miami in the enforcement of the regulated area.
    (c) Regulations. (1) Participants and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by Captain of the Port Miami or a
designated representative.
    (2) Persons and vessels may request authorization to enter, transit
through, anchor in, or remain within the regulated area by contacting
the Captain of the Port Miami by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16. If authorization
is granted by the Captain of the Port Miami or a designated
representative, all persons and vessels receiving such authorization
must comply with the instructions of the Captain of the Port Miami or a
designated representative.

    (d) Effective date. This rule will be effective from October 27,
2015 to November 15, 2015 and will be enforced with actual notice while
emergency salvage operations are ongoing.

    Dated: October 27, 2015.
M. C. Long,
Captain, U.S. Coast Guard, Acting Captain of the Port Miami.
[FR Doc. 2015-27751 Filed 10-30-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Pages 3932-3933]
[FR Doc No: 2011-1192]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2011-03]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary

is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before February 10, 2011.

ADDRESSES: You may send comments identified by Docket Number FAA-2010-
1268 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kenna Sinclair, ANM-113, (425) 227-
1556, Federal Aviation Administration, 1601 Lind Avenue, SW., Renton,
WA 98057-3356, or Frances Shaver,<PHONE_NUMBER>). Office of Rulemaking
(ARM-1), Federal Aviation Administration, 800 Independence Avenue, SW.,
Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on January 14, 2011.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2010-1268.
    Petitioner: The Boeing Company.
    Section of 14 CFR Affected: Sec. Sec.  25.1305(c)(6) and
25.1309(c).
    Description of Relief Sought: Boeing requests a time-limited
exemption from the requirements to provide the flightcrew with an
indication of fuel system contamination for 747-8 and 747-8F airplanes
powered by General Electric GEnx-2B engines. The request would allow
non-compliant airplanes to be delivered until June 30, 2014, and
subsequent retrofit of design improvements by December 31, 2018.

[FR Doc. 2011-1192 Filed 1-20-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 163 (Thursday, August 22, 2019)]
[Rules and Regulations]
[Pages 43701-43703]
[FR Doc No: 2019-18036]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2019-0300; FRL-9998-41-Region 7]

Air Plan Approval; Missouri; Revision to Emission Data, Emission
Fees and Process Information Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) and Operating
Permits Program revision submitted by the State of Missouri on January
15, 2019. The revisions add definitions, remove language referring to
outdated emission fees, and update incorporations by reference in the
rule. The revision is administrative in nature and does not have an
adverse effect on air quality. The EPA's approval of this rule revision
is being done in accordance with the requirements of the Clean Air Act
(CAA).

DATES: This final rule is effective on September 23, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2019-0300. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available through https://www.regulations.gov or please contact

the person identified in the FOR FURTHER INFORMATION CONTACT section
for additional information.

FOR FURTHER INFORMATION CONTACT: Jonathan Meyer, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number (913) 551-
7140; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Background
II. What is being addressed in this document?
III. Have the requirements for approval of a SIP revision and
operating permits program been met?
IV. What action is the EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Background

    On June 11, 2019, the EPA proposed to approve revisions to the
Missouri SIP and Operating Permits Program in the Federal Register. See
84 FR 27055. The proposed revisions added definitions, removed language
referring to outdated emission fees, and updated incorporations by
reference in the rule. The EPA solicited comments on the proposed
revisions to Missouri's SIP and Operating Permits Program, and received
one comment. The comment was not related to the proposed rule and
therefore a response is not required.

II. What is being addressed in this document?

    The EPA is approving a revision to Missouri's SIP by approving the
state's request to revise 10 CSR 10-6.110, Reporting Emission Data,
Emission Fees, and Process Information, received January 15, 2019.
Missouri revised 10 CSR 10-6.110 to correct minor typographical errors.
    A detailed discussion of the revision to Missouri's SIP and
Operating Permits Program was provided in EPA's June 11, 2019, Federal
Register doument. See 84 FR 27055.

III. Have the requirements for approval of a SIP revision and operating
permits program been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
state provided public notice on this SIP revision from June 25, 2018,
to August 2, 2018, and received comments from the EPA and a regulated
entity. The state adequately addressed the public comments. In
addition, the revision meets the substantive SIP requirements of the
CAA, including section 110 and implementing regulations.

IV. What action is the EPA taking?

    We are taking final action to approve the revisions to Missouri's
SIP and Missouri's Operating Permits Program by approving the state's
request to revise 10 CSR 10-6.110, Reporting Emission Data, Emission
Fees, and Process Information.

V. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference of the
Missouri Regulations described in the amendments to 40 CFR part 52 set
forth below. The EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 7 Office (please contact the person identified in the For
Further Information Contact section of this preamble for more
information).
    Therefore, these materials have been approved by the EPA for
inclusion in the State implementation plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of the EPA's approval, and will be incorporated by reference
in the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VI. Statutory and Executive Order Reviews

    Under the CAA, 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, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     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 the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 21, 2019. 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

40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating permits,
Reporting and recordkeeping requirements.

    Dated: August 15, 2019.
Edward Chu,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA amends 40 CFR parts
52 and 70 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart AA--MISSOURI

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by revising
the entry for ``10-6.110'' to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                           State
       Missouri citation                Title         effective date    EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
    Chapter 6--Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control
                                      Regulations for the State of Missouri
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
10-6.110......................  Reporting Emission         1/30/2019  8/22/2019, [insert    Section (3)(A),
                                 Data, Emission                        Federal Register      Emissions Fees, has
                                 Fees, and Process                     citation].            not been approved
                                 Information.                                                as part of the SIP.

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

* * * * *

PART 70--STATE OPERATING PERMIT PROGRAMS

0
3. The authority citation for part 70 continues to read as follows:

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

0
4. Appendix A to part 70 is amended by adding paragraph (hh) under
``Missouri'' to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *
Missouri
* * * * *
    (hh) The Missouri Department of Natural Resources submitted
revisions to Missouri rule 10 CSR 10-6.110, ``Reporting Emission
Data, Emission Fees, and Process Information'' on January 15, 2019.
The state effective date is January 30, 2019. Approval of Section
3(A) of 10 CSR 10-6.110 is effective September 23, 2019.
* * * * *
[FR Doc. 2019-18036 Filed 8-21-19; 8:45 am]
 BILLING CODE 6560-50-P


(ii) The owner or operator is monitoring emissions from the unit with another certified monitoring system approved, in accordance with the applicable provisions of this subpart and part 75 of this chapter, by the Administrator for use at that unit that provides emission data for the same pollutant or parameter as the retired or discontinued monitoring system; or
            (iii) The designated representative submits notification of the date of certification testing of a replacement monitoring system for the retired or discontinued monitoring system in accordance with § 97.931(d)(3)(i).
      (e) Long-term cold storage.
         The owner or operator of a Texas SO2 Trading Program unit is subject to the applicable provisions of § 75.4(d) of this chapter concerning units in long-term cold storage.
§ 97.931   Initial monitoring system certification and recertification procedures.
   (a) The owner or operator of a Texas SO2 Trading Program unit shall be exempt from the initial certification requirements of this section for a monitoring system under § 97.930(a)(1) if the following conditions are met:
      (1) The monitoring system has been previously certified in accordance with part 75 of this chapter; and
      (2) The applicable quality-assurance and quality-control requirements of § 75.21 of this chapter and appendices B and D to part 75 of this chapter are fully met for the certified monitoring system described in paragraph (a)(1) of this section.
   (b) The recertification provisions of this section shall apply to a monitoring system under § 97.930(a)(1) that is exempt from initial certification requirements under paragraph (a) of this section.
   (c) [Reserved]
   (d) Except as provided in paragraph (a) of this section, the owner or operator of a Texas SO2 Trading Program unit shall comply with the following initial certification and recertification procedures, for a continuous monitoring system (i.e., a continuous emission monitoring system and an excepted monitoring system under appendix D to part 75 of this chapter) under § 97.930(a)(1). The owner or operator of a unit that qualifies to use the low mass emissions excepted monitoring methodology under § 75.19 of this chapter or that qualifies to use an alternative monitoring system under subpart E of part 75 of this chapter shall comply with the procedures in paragraph (e) or (f) of this section respectively.
      (1) Requirements for initial certification.
         The owner or operator shall ensure that each continuous monitoring system under § 97.930(a)(1) (including the automated data acquisition and handling system) successfully completes all of the initial certification testing required under § 75.20 of this chapter by the applicable deadline in § 97.930(b). In addition, whenever the owner or operator installs a monitoring system to meet the requirements of this subpart in a location where no such monitoring system was previously installed, initial certification in accordance with § 75.20 of this chapter is required.
      (2) Requirements for recertification.
         Whenever the owner or operator makes a replacement, modification, or change in any certified continuous emission monitoring system under § 97.930(a)(1) that may significantly affect the ability of the system to accurately measure or record SO2 mass emissions or heat input rate or to meet the quality-assurance and quality-control requirements of § 75.21 of this chapter or appendix B to part 75 of this chapter, the owner or operator shall recertify the monitoring system in accordance with § 75.20(b) of this chapter. Furthermore, whenever the owner or operator makes a replacement, modification, or change to the flue gas handling system or the unit's operation that may significantly change the stack flow or concentration profile, the owner or operator shall recertify each continuous emission monitoring system whose accuracy is potentially affected by the change, in accordance with § 75.20(b) of this chapter. Examples of changes to a continuous emission monitoring system that require recertification include replacement of the analyzer, complete replacement of an existing continuous emission monitoring system, or change in location or orientation of the sampling probe or site. Any fuel flowmeter system under § 97.930(a)(1) is subject to the recertification requirements in § 75.20(g)(6) of this chapter.
      (3) Approval process for initial certification and recertification.
         For initial certification of a continuous monitoring system under § 97.930(a)(1), paragraphs (d)(3)(i) through (v) of this section apply. For recertifications of such monitoring systems, paragraphs (d)(3)(i) through (iv) of this section and the procedures in § 75.20(b)(5) and (g)(7) of this chapter (in lieu of the procedures in paragraph (d)(3)(v) of this section) apply, provided that in applying paragraphs (d)(3)(i) through (iv) of this section, the words "certification" and "initial certification" are replaced by the word "recertification" and the word "certified" is replaced by the word "recertified".
            (i) Notification of certification.
               The designated representative shall submit to the appropriate EPA Regional Office and the Administrator written notice of the dates of certification testing, in accordance with § 97.933.
            (ii) Certification application.
               The designated representative shall submit to the Administrator a certification application for each monitoring system. A complete certification application shall include the information specified in § 75.63 of this chapter.
            (iii) Provisional certification date.
               The provisional certification date for a monitoring system shall be determined in accordance with § 75.20(a)(3) of this chapter. A provisionally certified monitoring system may be used under the Texas SO2 Trading Program for a period not to exceed 120 days after receipt by the Administrator of the complete certification application for the monitoring system under paragraph (d)(3)(ii) of this section. Data measured and recorded by the provisionally certified monitoring system, in accordance with the requirements of part 75 of this chapter, will be considered valid quality-assured data (retroactive to the date and time of provisional certification), provided that the Administrator does not invalidate the provisional certification by issuing a notice of disapproval within 120 days of the date of receipt of the complete certification application by the Administrator.
            (iv) Certification application approval process.
               The Administrator will issue a written notice of approval or disapproval of the certification application to the owner or operator within 120 days of receipt of the complete certification application under paragraph (d)(3)(ii) of this section. In the event the Administrator does not issue such a notice within such 120-day period, each monitoring system that meets the applicable performance requirements of part 75 of this chapter and is included in the certification application will be deemed certified for use under the Texas SO2 Trading Program.
                  (A) Approval notice.
                     If the certification application is complete and shows that each monitoring system meets the applicable performance requirements of part 75 of this chapter, then the Administrator will issue a written notice of approval of the certification application within 120 days of receipt.
                  (B) Incomplete application notice.
                     If the certification application is not complete, then the Administrator will issue a written notice of incompleteness that sets a reasonable date by which the designated representative must submit the additional information required to complete the certification application. If the designated representative does not comply with the notice of incompleteness by the specified date, then the Administrator may issue a notice of disapproval under paragraph (d)(3)(iv)(C) of this section.
                  (C) Disapproval notice.
                     If the certification application shows that any monitoring system does not meet the performance requirements of part 75 of this chapter or if the certification application is incomplete and the requirement for disapproval under paragraph (d)(3)(iv)(B) of this section is met, then the Administrator will issue a written notice of disapproval of the certification application. Upon issuance of such notice of disapproval, the provisional certification is invalidated by the Administrator and the data measured and recorded by each uncertified monitoring system shall not be considered valid quality-assured data beginning with the date and hour of provisional certification (as defined under § 75.20(a)(3) of this chapter).
                  (D) Audit decertification.
                     The Administrator may issue a notice of disapproval of the certification status of a monitor in accordance with § 97.932(b).
            (v) Procedures for loss of certification.
               If the Administrator issues a notice of disapproval of a certification application under paragraph (d)(3)(iv)(C) of this section or a notice of disapproval of certification status under paragraph (d)(3)(iv)(D) of this section, then:
                  (A) The owner or operator shall substitute the following values, for each disapproved monitoring system, for each hour of unit operation during the period of invalid data specified under § 75.20(a)(4)(iii), § 75.20(g)(7), or § 75.21(e) of this chapter and continuing until the applicable date and hour specified under § 75.20(a)(5)(i) or (g)(7) of this chapter:
                     (1) For a disapproved SO2 pollutant concentration monitor and disapproved flow monitor, respectively, the maximum potential concentration of SO2 and the maximum potential flow rate, as defined in sections <IP_ADDRESS> and <IP_ADDRESS> of appendix A to part 75 of this chapter.
                     (2) For a disapproved moisture monitoring system and disapproved diluent gas monitoring system, respectively, the minimum potential moisture percentage and either the maximum potential CO2 concentration or the minimum potential O2 concentration (as applicable), as defined in sections 2.1.5, <IP_ADDRESS>, and <IP_ADDRESS> of appendix A to part 75 of this chapter.
                     (3) For a disapproved fuel flowmeter system, the maximum potential fuel flow rate, as defined in section <IP_ADDRESS> of appendix D to part 75 of this chapter.
                  (B) The designated representative shall submit a notification of certification retest dates and a new certification application in accordance with paragraphs (d)(3)(i) and (ii) of this section.
                  (C) The owner or operator shall repeat all certification tests or other requirements that were failed by the monitoring system, as indicated in the Administrator's notice of disapproval, no later than 30 unit operating days after the date of issuance of the notice of disapproval.
   (e) The owner or operator of a unit qualified to use the low mass emissions (LME) excepted methodology under § 75.19 of this chapter shall meet the applicable certification and recertification requirements in §§ 75.19(a)(2) and 75.20(h) of this chapter. If the owner or operator of such a unit elects to certify a fuel flowmeter system for heat input determination, the owner or operator shall also meet the certification and recertification requirements in § 75.20(g) of this chapter.
   (f) The designated representative of each unit for which the owner or operator intends to use an alternative monitoring system approved by the Administrator under subpart E of part 75 of this chapter shall comply with the applicable notification and application procedures of § 75.20(f) of this chapter.
§ 97.932   Monitoring system out-of-control periods.
   (a) General provisions.
      Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter.
   (b) Audit decertification.
      Whenever both an audit of a monitoring system and a review of the initial certification or recertification application reveal that any monitoring system should not have been certified or recertified because it did not meet a particular performance specification or other requirement under § 97.931 or the applicable provisions of part 75 of this chapter, both at the time of the initial certification or recertification application submission and at the time of the audit, the Administrator will issue a notice of disapproval of the certification status of such monitoring system. For the purposes of this paragraph, an audit shall be either a field audit or an audit of any information submitted to the Administrator or any State or permitting authority. By issuing the notice of disapproval, the Administrator revokes prospectively the certification status of the monitoring system. The data measured and recorded by the monitoring system shall not be considered valid quality-assured data from the date of issuance of the notification of the revoked certification status until the date and time that the owner or operator completes subsequently approved initial certification or recertification tests for the monitoring system. The owner or operator shall follow the applicable initial certification or recertification procedures in § 97.931 for each disapproved monitoring system.
§ 97.933   Notifications concerning monitoring.
   The designated representative of a Texas SO2 Trading Program unit shall submit written notice to the Administrator in accordance with § 75.61 of this chapter.
§ 97.934   Recordkeeping and reporting.
   (a) General provisions.
      The designated representative of a Texas SO2 Trading Program unit shall comply with all recordkeeping and reporting requirements in paragraphs (b) through (e) of this section, the applicable recordkeeping and reporting requirements in subparts F and G of part 75 of this chapter, and the requirements of § 97.914(a).
   (b) Monitoring plans.
      The owner or operator of a Texas SO2 Trading Program unit shall comply with the requirements of § 75.62 of this chapter.
   (c) Certification applications.
      The designated representative shall submit an application to the Administrator within 45 days after completing all initial certification or recertification tests required under § 97.931, including the information required under § 75.63 of this chapter.
   (d) Quarterly reports.
      The designated representative shall submit quarterly reports, as follows:
         (1) The designated representative shall report the SO2 mass emissions data and heat input data for a Texas SO2 Trading Program unit, in an electronic quarterly report in a format prescribed by the Administrator, for each calendar quarter beginning with the calendar quarter covering January 1, 2019 through March 31, 2019.
         (2) The designated representative shall submit each quarterly report to the Administrator within 30 days after the end of the calendar quarter covered by the report. Quarterly reports shall be submitted in the manner specified in § 75.64 of this chapter.
         (3) For Texas SO2 Trading Program units that are also subject to the Acid Rain Program, CSAPR NOX Ozone Season Group 2 Trading Program, or CSAPR NOX Ozone Season Group 3 Trading Program, quarterly reports shall include the applicable data and information required by subparts F through H of part 75 of this chapter as applicable, in addition to the SO2 mass emission data, heat input data, and other information required by this subpart.
         (4) The Administrator may review and conduct independent audits of any quarterly report in order to determine whether the quarterly report meets the requirements of this subpart and part 75 of this chapter, including the requirement to use substitute data.
            (i) The Administrator will notify the designated representative of any determination that the quarterly report fails to meet any such requirements and specify in such notification any corrections that the Administrator believes are necessary to make through resubmission of the quarterly report and a reasonable time period within which the designated representative must respond. Upon request by the designated representative, the Administrator may specify reasonable extensions of such time period. Within the time period (including any such extensions) specified by the Administrator, the designated representative shall resubmit the quarterly report with the corrections specified by the Administrator, except to the extent the designated representative provides information demonstrating that a specified correction is not necessary because the quarterly report already meets the requirements of this subpart and part 75 of this chapter that are relevant to the specified correction.
            (ii) Any resubmission of a quarterly report shall meet the requirements applicable to the submission of a quarterly report under this subpart and part 75 of this chapter, except for the deadline set forth in paragraph (d)(2) of this section.
   (e) Compliance certification.
      The designated representative shall submit to the Administrator a compliance certification (in a format prescribed by the Administrator) in support of each quarterly report based on reasonable inquiry of those persons with primary responsibility for ensuring that all of the unit's emissions are correctly and fully monitored. The certification shall state that:
         (1) The monitoring data submitted were recorded in accordance with the applicable requirements of this subpart and part 75 of this chapter, including the quality assurance procedures and specifications; and
         (2) For a unit with add-on SO2 emission controls and for all hours where SO2 data are substituted in accordance with § 75.34(a)(1) of this chapter, the add-on emission controls were operating within the range of parameters listed in the quality assurance/quality control program under appendix B to part 75 of this chapter and the substitute data values do not systematically underestimate SO2 emissions.
§ 97.935   Petitions for alternatives to monitoring, recordkeeping, or reporting requirements.
   (a) The designated representative of a Texas SO2 Trading Program unit may submit a petition under § 75.66 of this chapter to the Administrator, requesting approval to apply an alternative to any requirement of §§ 97.930 through 97.934.
   (b) A petition submitted under paragraph (a) of this section shall include sufficient information for the evaluation of the petition, including, at a minimum, the following information:
      (1) Identification of each unit and source covered by the petition;
      (2) A detailed explanation of why the proposed alternative is being suggested in lieu of the requirement;
      (3) A description and diagram of any equipment and procedures used in the proposed alternative;
      (4) A demonstration that the proposed alternative is consistent with the purposes of the requirement for which the alternative is proposed and with the purposes of this subpart and part 75 of this chapter and that any adverse effect of approving the alternative will be de minimis; and
      (5) Any other relevant information that the Administrator may require.
   (c) Use of an alternative to any requirement referenced in paragraph (a) of this section is in accordance with this subpart only to the extent that the petition is approved in writing by the Administrator and that such use is in accordance with such approval.