[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Rules and Regulations]
[Pages 47371-47373]
[FR Doc No: 2017-21443]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0648; Product Identifier 2017-CE-012-AD; Amendment
39-19070; AD 2017-20-13]
RIN 2120-AA64

Airworthiness Directives; PIAGGIO AERO INDUSTRIES S.p.A.
Airplanes

AGENCY:  Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for PIAGGIO
AERO INDUSTRIES S.p.A. Model P-180 airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as disbonding of the upper and lower metal skin from the
honeycomb core on the elevator assembly and other flight control
surfaces. We are issuing this AD to require actions to address the
unsafe condition on these products.

DATES: This AD is effective November 16, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 16,
2017.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0638; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact PIAGGIO AERO
INDUSTRIES S.p.A--Continued Airworthiness, Via Pionieri e Aviatori
d'Italia snc--16154 Genova, Italy; Telephone: +39<PHONE_NUMBER>; Fax:
None; email<EMAIL_ADDRESS>Internet:
www.piaggioaerospace.it/en/customer-support#care. You may view this
referenced service information at the FAA, Policy and Innovation
Division, 901 Locust, Kansas City, Missouri 64106. 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 Docket No. FAA-2017-0648.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain PIAGGIO AERO
INDUSTRIES S.p.A. Model P-180 airplanes. The NPRM was published in the
Federal Register on June 29, 2017 (82 FR 29445). The NPRM proposed to
correct an unsafe condition for the specified products and was based on
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country. The MCAI states:

    During a post flight inspection of a right hand (RH) elevator
assembly, disbonding was detected on the upper and lower metal skin
from the honeycomb core. Subsequent investigation identified that a
manufacturing deficiency caused the detected disbonding and that
other flight control surfaces could potentially be affected by the
same deficiency.
    This condition, if not detected and corrected, could reduce the
structural stiffness of the flight control surface and downgrade its
aerodynamic characteristics, possibly resulting in reduced control
of the aeroplane.
    To address this potential unsafe condition, Piaggio Aero
Industries (PAI) issued Service Bulletin (SB) 80-0455 to provide
inspection instructions.
    For the reasons described above, this [EASA] AD requires
repetitive inspections of the affected flight control assemblies
and, depending on findings, repair or replacement. This [EASA] AD
also requires reporting of the inspection result to PAI.

    The MCAI can be found in the AD docket on the Internet at https://www.regulations.gov/document?D=FAA-2017-064-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed PIAGGIO AERO INDUSTRIES S.p.A. Mandatory Service
Bulletin N.: 80-0455, dated: January 13, 2017. This service information
describes procedures for repetitive inspections to verify the
structural integrity of the flight control assemblies. 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 of this AD.

Costs of Compliance

    We estimate that this AD will affect 103 products of U.S. registry.
We also estimate that it will take 9 work-hours per product to comply
with the basic requirements of this AD. The average labor rate is $85
per work-hour.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $78,795, or $765 per product.
    The scope of damage found in the required inspections could vary
significantly from airplane to airplane. We have no way of determining
how much damage may be found on each airplane or the cost to repair
damaged parts on each airplane.
    In addition, we have no way of knowing how many products may need
replacement as a result of the required inspections. The following cost
estimates were obtained directly from the manufacturer and we estimate
that any necessary follow-on replacement actions would cost as follows:
    (i) Control surface repair: 10 work-hours for a cost of $850 per
product.
    (ii) Left Hand (LH) Forward Wing Flap Replacement: 4 work-hours and
require parts costing $30,079, for a total cost of $30,419.
    (iii) Right Hand (RH) Forward Wing Flap Replacement: 4 work-hours
and require parts costing $30,079, for a total cost of $30,419.
    (iv) LH Aileron Assembly: 7 work-hours and require parts costing
$40,715, for a total cost of $41,310.
    (v) RH Aileron Assembly: 7 work-hours and require parts costing
$86,050, for a total cost of $86,645.
    (vi) Main Wing LH Inboard Flap Assembly: 4 work-hours and require
parts costing $22,699, for a total cost of $23,039.
    (vii) Main Wing RH Inboard Flap Assembly: 4 work-hours and require

parts costing $22,699, for a total cost of $23,039.
    (viii) LH Elevator Assembly: 8 work-hours and require parts costing
$59,917, for a total cost of $60,597.
    (ix) RH Elevator Assembly: 8 work-hours and require parts costing
$59,917, for a total cost of $60,597.
    There is an additional 10 work-hours that may be required for post-
repair or post-installation replacement of flight control surface
adjustments and testing, for a total cost of $850.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes and domestic
business jet transport airplanes to the Director of the Policy and
Innovation Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will 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 AD:
    (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.

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-2017-
0648; 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 the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 AD:

2017-20-13 Piaggio Aero Industries S.p.A.: Amendment 39-19070;
Docket No. FAA-2017-0648; Product Identifier 2017-CE-012-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective November 16,
2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to PIAGGIO AERO INDUSTRIES S.p.A. P-180
airplanes, serial numbers 1002, 1004 through 1220, that are:
    (1) Equipped with flight control surfaces part numbers (P/Ns)
and serial numbers (S/Ns) not listed in table 1 of PIAGGIO AERO
INDUSTRIES S.p.A. Mandatory Service Bulletin N.: 80-0455, dated:
January 13, 2017 (PAI SB No. 80-0455); and
    (2) certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as disbonding of
the upper and lower metal skin from the honeycomb core on the
elevator assembly and other flight control surfaces. We are issuing
this AD to prevent structural stiffness of the flight control
surface and the downgrade of its aerodynamic characteristics,
resulting in reduced control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(8) of this AD. The parts affected by this AD are all left hand (LH)
forward flaps, right hand (RH) forward flaps, main wing LH inboard
flaps, main wing RH inboard flaps, LH ailerons, RH ailerons, LH
elevators, and RH elevators, hereafter referred to as ``affected
control surface'' in this AD.
    (1) Within the next 50 hours time-in-service (TIS) after
November 16, 2017 (the effective date of this AD) or within the next
200 hours TIS after the last coin tapping inspection of the affected
control surface following PAI Non-Destructive Test Manual (NDTM)
180-MAN-0300-01107, Chapter 51-00-01; whichever occurs later, do a
coin tapping inspection of each affected control surface.
Repetitively thereafter inspect at the intervals specified in
paragraphs (f)(3)(i) and (ii). Follow Part B of the Accomplishment
Instructions in PAI SB No. 80-0455.
    (i) Do two repetitive inspections at intervals not to exceed 200
hours TIS; and
    (ii) Repetitively thereafter inspect at intervals not to exceed
600 hours TIS.
    (2) If damage is found during any inspection required in
paragraph (f)(1) of this AD, before further flight, repair or
replace as necessary each damaged affected control surface following
Part B and/or C of the Accomplishment Instructions in PAI SB No. 80-
0455.
    (3) Within 50 hours TIS after the repair of an affected control
surface as required by paragraph (f)(2) of this AD, do a coin
tapping inspection of that repaired affected control surface.
Repetitively thereafter inspect at the intervals specified in
paragraphs (f)(3)(i) and (ii) of this AD. Follow the instructions in
PAI SB No. 80-0455.
    (i) Do two repetitive inspections at intervals not to exceed 200
hours TIS; and
    (ii) Repetitively thereafter inspect at intervals not to exceed
600 hours TIS.
    (4) If damage is found during any inspection required in
paragraph (f)(3) of this AD, before further flight, repair or
replace as necessary each damaged affected control surface following
the instructions in Part B and/or C of the Accomplishment
Instructions in PAI SB No. 80-0455.
    (5) Repair of an affected control surface, as required by
paragraph (f)(2) or (4) of this AD, does not constitute terminating
action for repetitive inspections as required by this AD

for that affected control surface, unless the FAA-approved repair
instructions specify otherwise.
    (6) Replacement of the affected part on an airplane with a part
listed in table 1 of PAI SB No. 80-0455, constitutes terminating
action for the repetitive inspections required by this AD for that
part.
    (7) You may incorporate the actions of PAI SB No. 80-0455, into
your FAA-approved airplane inspection program (AIP) or maintenance
program (instructions for continued airworthiness) to ensure the
continuing airworthiness of each operated airplane.
    (8) After November 16, 2017 (the effective date of this AD), you
may install on an airplane an affected control surface not listed in
table 1 of PAI SB No. 80-0455, provided that before further flight
after installation, the affected control surface has been inspected
as specified in this AD and found airworthy.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, Small
Airplane Standards Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, Small Airplane
Standards Branch, FAA; or the European Aviation Safety Agency
(EASA).
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2017-0045, dated March 9, 2017 for related information. You may
examine the MCAI on the Internet at https://www.regulations.gov/document?D=FAA-2017-0648-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) PIAGGIO AERO INDUSTRIES S.p.A. Mandatory Service Bulletin
(SB) No.: 80-0455, dated January 13, 2017.
    (ii) Reserved.
    (3) For PIAGGIO AERO INDUSTRIES S.p.A. service information
identified in this AD, contact PIAGGIO AERO INDUSTRIES S.p.A.--
Continued Airworthiness, Via Pionieri e Aviatori d'Italia snc--16154
Genova, Italy; Telephone: +39<PHONE_NUMBER>; Fax: None; email:
<EMAIL_ADDRESS>Internet:
www.piaggioaerospace.it/en/customer-support#care.
    (4) You may view this service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0648.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on September 29, 2017.
Pat Mullen,
Acting Deputy Director, Policy & Innovation Division, Aircraft
Certification Service.
[FR Doc. 2017-21443 Filed 10-11-17; 8:45 am]
 BILLING CODE 4910-13-P


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California Association of Nurseries and Garden Centers CUE application
for 2007

For more information please contact Marta Montoro by phone at
202-343-9321 or by email at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Rules and Regulations]
[Page 61740-61742]
[DOCID:fr17oc08-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 49

[EPA-R10-OAR-2008-0498; FRL-8729-3]

Announcement of the Delegation of Partial Administrative
Authority for Implementation of Federal Implementation Plan for the
Coeur d'Alene Reservation to the Coeur d'Alene Tribe

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; technical amendment.

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SUMMARY: This action announces that on August 26, 2008, EPA Region 10,
and the Coeur d'Alene Tribe, entered into a Partial Delegation of
Administrative Authority to carry out certain day-to-day activities
associated with implementation of the Federal Implementation Plan for
the Coeur d'Alene Reservation (Coeur d'Alene FIP). A note of this
partial delegation is being added to the Coeur d'Alene FIP.

DATES: This rule is effective October 17, 2008. The partial delegation
of administrative authority was effective August 26, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R10-OAR-2008-0130. The delegation agreement and other docket
materials are available electronically at EPA's electronic public
docket and comment system, found at http://www.regulations.gov or in
hard copy from Steve Body, Office of Air Waste and Toxics, AWT-107, EPA
Region 10, Suite 900, 1200 Sixth Avenue, Seattle, WA 98101, or via e-
mail at<EMAIL_ADDRESS>Additional information may also be obtained
from the Coeur d'Alene Tribe by contacting Les Higgins, Coeur d'Alene
Tribe, P.O. Box 408, Plummer, Idaho, 83851-9703 or via e-mail at
<EMAIL_ADDRESS>    All documents in the electronic docket are listed in the http://
www.regulations.gov index. 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 either electronically in http://
www.regulations.gov or in hard copy during normal business hours at the
Office of Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue,
Seattle, Washington 98101.

FOR FURTHER INFORMATION CONTACT: Steve Body at telephone number (206)
553-0782, e-mail address<EMAIL_ADDRESS>or the EPA Region 10
address.

SUPPLEMENTARY INFORMATION: The purpose of this action is to announce
that on August 26, 2008, EPA Region 10, delegated partial
administrative authority for implementation of certain provisions of
the Coeur d'Alene FIP to the Coeur d'Alene Tribe. See 40 CFR part 49,
subpart M, Sec. Sec.  9921 through 9930, as authorized by 40 CFR 49.122
of the Federal Air Rules for Reservations (FARR), 40 CFR part 49,
subpart C.

I. Authority To Delegate

    Federal regulation 40 CFR 49.122 provides EPA authority to delegate
to

Indian Tribes partial administrative authority to implement provisions
of the Federal Air Rules for Reservations (FARR), 40 CFR part 49,
subpart C. Tribes must submit a request to the Regional Administrator
that meets the requirements of 40 CFR 49.122.

II. Request for Delegation

    On October 4, 2007, Chief J. Allen, Chairman of the Coeur d'Alene
Tribal Council submitted to the Regional Administrator a request for
delegation of certain provision of the Coeur d'Alene FIP. That request
included all the information and demonstrations required by the FARR
for delegation. A copy of all documentation is on file at EPA Region
10, Seattle, Washington (see ADDRESSES above).
    The Coeur d'Alene Tribe requested delegation for the following
provisions; 40 CFR 49.9930 (b) Rule for limiting visible emissions, 40
CFR 49.9930 (g) General rule for open burning, and 40 CFR 49.9930 (i)
Rule for air pollution episodes.

III. EPA Response to the Request for Delegation

    EPA and the Coeur d'Alene Tribe signed the Delegation Agreement
that specifies the provisions and authorities delegated. The Coeur
d'Alene Tribe is delegated the following provisions: 40 CFR 49.9930 (b)
Rule for limiting visible emissions, 40 CFR 49.9930 (g) General rule
for open burning, and 40 CFR 49.9930 (i) Rule for air pollution
episodes. In addition, the agreement delegates to the Tribe authority
to investigate complaints and assist EPA in inspections. The Agreement
also includes terms and conditions applicable to the delegation. A copy
of the Agreement is kept at EPA Region 10 at the address above.
    EPA solicited by letter, advice and insight from the State of
Idaho, the State of Washington, Kootenai County, Benewah County, cities
of St. Maries and Worley, and St. Joe National Forest on the Coeur
d'Alene Tribe's request for delegation. In general the comments
received supported delegation. Adverse comments were received from
Kootenai and Benewah Counties. A response to those comments was
prepared and is included in the docket for this action.
    Section 553 of the Administrative Procedure Act, 5 U.S.C. 553
(b)(B), provides that, when an agency for good cause finds that notice
and public procedure are impracticable, unnecessary or contrary to the
public interest, the agency may issue a rule without providing notice
and an opportunity for public comment. EPA has determined that there is
good cause for making today's rule final without prior proposal and
opportunity for comment because EPA is merely informing the public of
partial delegation of administrative authority to the Coeur d'Alene
Tribe and making a technical amendment to the Code of Federal
Regulations (CFR) by adding a note announcing the partial delegation.
Thus, notice and public procedure are unnecessary. EPA finds that this
constitutes good cause under 5 U.S.C. 553(b)(B).
    Moreover, since today's action does not create any new regulatory
requirements, EPA finds that good cause exists to provide for an
immediate effective date pursuant to 5 U.S.C. 553(d)(3).

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely makes a technical amendment and gives notice of a partial
delegation of administrative authority. Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). This rule 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).
    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' Under section 5(b) of Executive
Order 13175, EPA may not issue a regulation that has tribal
implications, that imposes substantial direct compliance costs, and
that is not required by statute, unless the Federal government provides
the funds necessary to pay the direct compliance costs incurred by
tribal governments, or EPA consults with tribal officials early in the
process of developing the proposed regulation. Under section 5(c) of
Executive Order 13175, EPA may not issue a regulation that has tribal
implications and that preempts tribal law, unless the Agency consults
with tribal officials early in the process of developing the
regulation. EPA has concluded that this rule may have tribal
implications. EPA's action fulfills a requirement to publish a notice
announcing partial delegation of administrative authority to the Coeur
d'Alene Tribe and noting the partial delegation in the CFR. However, it
will neither impose substantial direct compliance costs on tribal
governments, nor preempt tribal law. Thus, the requirements of sections
5(b) and 5(c) of the Executive Order do not apply to this rule.
    This action also does not have Federalism implications because it
does not have substantial direct effects on the states, on the
relationship between the national government and the states, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This technical amendment merely notes that partial
delegation of administrative authority to the Coeur d'Alene Tribe is in
effect. This rule also is not subject to Executive Order 13045,
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant.
    This action does not involve technical standards; thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule
does not impose an information collection burden under the provisions
of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    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 rule 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 by December 16, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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 49

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

    Dated: September 22, 2008.
Michelle Pirzadeh,
Acting Regional Administrator, Region 10.

0
Chapter I, title 40 of the Code of Federal Regulations is amended as
follows:

PART 49--[AMENDED]

0
1. The authority citation for part 49 continues to read as follows:

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

Subpart M--[Amended]

0
2. Section 49.9930 is amended by adding a note to the end of the
section to read as follows:

Sec.  49.9930  Federally-promulgated regulations and Federal
implementation plans.

* * * * *

    Note to Sec.  49.9930: EPA entered into a Partial Delegation of
Administrative Authority with the Coeur d'Alene Tribe on August 26,
2008 for the rules listed in paragraphs (b), (g), and (i) of this
section.

[FR Doc. E8-24428 Filed 10-16-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: September 5, 2006 (Volume 71, Number 171)]
[Notices]
[Page 52327-52329]
[DOCID:fr05se06-29]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2006-0494; FRL-8075-3]

Lead-Based Paint Activities; State of Hawaii Lead-Based Paint
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; requests for comments and opportunity for public
hearing.

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SUMMARY: On November 17, 2005, EPA received an application from the
State of Hawaii requesting authorization to administer a program in
accordance with section 402 of the Toxic Substances Control Act (TSCA).
Included in the application was a letter signed by Hawaii's Attorney
General stating that the State's Lead-Based Paint Abatement Program is
at least as protective of human health and the environment as the
Federal program under TSCA section 402. Also included in the letter
from the Attorney General of Hawaii is the certification that the laws
and regulations of the State of Hawaii provide adequate legal authority
to administer and enforce TSCA section 402. The application was
followed by a transmittal letter of February 8, 2006, from the Governor
of the State of Hawaii requesting program approval. Hawaii certifies
that its program meets the requirements for approval of a State program
under TSCA section 404 and that Hawaii has the legal authority and
ability to implement the appropriate elements necessary to enforce the
program. Therefore, pursuant to TSCA section 404, the program is deemed
authorized as of the date of submission. If EPA finds that the program
does not meet the requirements for approval of a State program, EPA
will disapprove the program, at which time a notice will be issued in
the Federal Register and the Federal program will be established. This
notice announces the receipt of Hawaii's application, provides a 45-day
public comment period, and an opportunity to request a public hearing
on the application.

DATES: Comments on the application must be received on or before
October 20, 2006.

ADDRESSES: Submit all written comments and/or requests for a public
hearing identified by docket identification (ID) numberEPA-HQ-OPPT-
2006-0494, by one of the following methods:
     Federal eRulemaking Portal:http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Nancy Oien, Regional Lead Coordinator, Environmental
Protection

Agency, Region IX, CED-4, 75 Hawthorne St., San Francisco, CA 94105-
3901.
     Delivery: Environmental Protection Agency, Region IX, CED-
4, 75 Hawthorne St., San Francisco, CA 94105-3901.
    Instructions: Direct your comments to Docket ID number EPA-HQ-OPPT-
2006-0494. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
athttp://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going throughregulations.gov, your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of the
comment and with any disk or CD ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage athttp://www.epa.gov/epahome/dockets.htm.

    Comments, data, and requests for a public hearing may also be
submitted electronically to<EMAIL_ADDRESS>    Docket: All documents in the docket are listed in thedocket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically athttp://www.regulations.gov
 or in hard copy at the EPA Region IX Library at 75

Hawthorne St., San Francisco, CA 94105. This docket facility is open
from 8 a.m. to noon and 1 p.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket facility telephone number is (415)
947-4406.

FOR FURTHER INFORMATION CONTACT: Nancy Oien, Regional Lead Coordinator,
Region IX, CED-4, 75 Hawthorne St., San Francisco, CA 94105-3901;
telephone:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General

A. Does this Action Apply to Me?

    This notice is directed to the public in general. This notice may,
however, be of interest to firms and individuals engaged in lead-based
paint activities in Hawaii. Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by the notice. If you have any questions
regarding the applicability of this notice to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's Authority for Taking this Action?

    On October 28, 1992, the Housing and Community Development Act of
1992, Public Law 102-550, became law. Title X of that statute was the
Residential Lead-Based Paint Hazard Reduction Act of 1992. The Act
amended TSCA (15 U.S.C. 2601 et seq.) by adding Title IV (15 U.S.C.
2681-2692), titled ``Lead Exposure Reduction.''
    Section 402 of TSCA (15 U.S.C. 2682) authorizes and directs EPA to
promulgate final regulations governing lead-based paint activities in
target housing, public and commercial buildings, bridges, and other
structures. On August 29, 1996 (61 FR 45777) (FRL-5389-9), EPA
promulgated final TSCA section 402/404 regulations governing lead-based
paint activities in target housing and child-occupied facilities (a
subset of public buildings). These regulations are to ensure that
individuals engaged in such activities are properly trained, that
training programs are accredited, and that individuals engaged in these
activities are certified and follow documented work practice standards.
Under TSCA section 404 (15 U.S.C. 2684), a State or Indian Tribe may
seek authorization from EPA to administer and enforce its own lead-
based paint activities program.
    States and Tribes that choose to apply for program authorization
must submit a complete application to the appropriate Regional EPA
Office for review. EPA will review those applications within 180 days
of receipt of the complete application. To receive EPA approval, a
State or Tribe must demonstrate that its program is at least as
protective of human health and the environment as the Federal program,
and provides for adequate enforcement (section 404(b) of TSCA, 15
U.S.C. 2684(b)). EPA's regulations (40 CFR part 745, subpart Q) provide
the detailed requirements a State or Tribal program must meet in order
to obtain EPA authorization.
    A State may choose to certify that its lead-based paint activities
program meets the requirements for EPA authorization by submitting a
letter signed by the Governor or the Attorney General stating that the
program meets the requirements of section 404(b) of TSCA. Upon
submission of such certification letter, the program is deemed
authorized until such time as EPA disapproves the program application
or withdraws the application.
    Section 404(b) of TSCA provides that EPA may approve a program
application only after providing notice and an opportunity for a public
hearing on the application. Therefore, by this notice EPA is soliciting
public comment on whether Hawaii's application meets the requirements
for EPA approval. This notice also provides an opportunity to request a
public hearing on the application. If EPA finds that the program does
not meet the requirements for authorization of a state program, EPA
will disapprove the program application, at which time a notice will be
issued in the Federal Register and the Federal program will be
established in Hawaii.

II. State Program Description Summary

    This summary is provided in accordance with 40 CFR 745.324(a)(4).
The applicant has provided the following summary of their lead program.
On September 19, 2005, Hawaii's Department of Health (HDH) adopted
Title 11, Chapter 11-41, Hawaii Administrative Rules titled ``Lead-
Based Paint Activities'' pursuant to Hawaii statutes in Chapters 91 and
92 and Hawaii's revised statute in section 321-11. These changes
authorized Hawaii's Department of Health to adopt and enforce
requirements equivalent to the requirements of 40 CFR part 745, subpart
L, into Hawaii's Administrative Rules in accordance with Hawaii's
Revised Statutes, Title 19, Chapter 342P.
    Public hearings were held on April 22, 2004, Hilo, Island of
Hawaii; April 23, 2004, Kailua Kona, Island of Hawaii; May 4, 2004,
Lihue, Kona; May 6, 2004, Wailuku, Maui; and May 7, 2004, Honolulu,
Oahu to consider comments on the proposed adoption of

administrative rule amendments and Hawaii's intent to seek EPA
authorization of its lead-based paint program. Comments were accepted
for 40 days after the published date of March 29, 2004. There were no
oral comments given at the hearings, but two sets of written comments
were received. The written comments were technical in nature and some
changes were made to remain as protective as the Federal standards.
These changes were reviewed by the State Attorney General who deemed
that no additional public hearing was required. The Post Hearing Small
Business Impact Statement was written and approved by the Small
Business Regulatory Review Board pursuant to section 201M-3, Hawaii
Revised Statutes and the Hawaii's Governor's Administrative Directive
No. 99-02.
    On September 19, 2005, the Governor of the State of Hawaii signed
the final rule. The final rule became effective on October 3, 2005. The
Hawaii Department of Health began implementing its program on October
3, 2005. Additional information, copies of the documents referenced
above, and application forms for licensing and certification may be
obtained by contacting: Tom Lileikis, Environmental Health Specialist,
Hawaii Health Department, Noise, Radiation, and Indoor Air Quality
Branch, 591 Ala Moana Blvd., 133, Honolulu, Hawaii 96813;
telephone number:<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>
    EPA determined that Hawaii's original application of November 17,
2005, was incomplete as the transmittal letter from the State Governor
requesting program approval was missing. The State of Hawaii submitted
the Governor's request on February 8, 2006, in accordance with 40 CFR
745.324(d), ``Program Certification,'' certifying that the State
program meets the requirements contained in 40 CFR 745.324(e)(2)(i) and
(e)(2)(ii). Therefore, as of November 17, 2005, the State of Hawaii is
authorized to administer and enforce the lead-based paint program under
TSCA section 402, until such time as the Administrator disapproves the
application or withdraws the State's program authorization.

III. Federal Overfiling

    Section 404(b) of TSCA (15 U.S.C. 2684(b)) makes it unlawful for
any person to violate, or fail or refuse to comply with, any
requirement of an approved State or Tribal program. Therefore, EPA
reserves the right to exercise its enforcement authority under TSCA
against a violation of, or a failure or refusal to comply with, any
requirement of an authorized State or Tribal program.

IV. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq. as amended by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before certain actions may take effect, the
agency promulgating the action must submit a report, which includes a
copy of the action, 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 this document in the
Federal Register. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects

    Environmental protection, Hazardous substances, Lead, Reporting and
recordkeeping requirements.

    Dated: August 3, 2006.
Laura Yoshii,
Acting Regional Administrator, Region IX.
[FR Doc. E6-14588 Filed 9-01-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 157 (Tuesday, August 14, 2012)]
[Notices]
[Page 48510]
[FR Doc No: 2012-19854]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-926-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Revisions to Form of Service Agreements and Delivery
Point Area Definitions to be effective 9/6/2012.
    Filed Date: 8/6/12.
    Accession Number: 20120806-5048.
    Comments Due: 5 p.m. ET 8/20/12.

    Docket Numbers: RP12-927-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Delivery Point Area (DPA) Revision Filing to be
effective 9/14/2011.
    Filed Date: 8/6/12.
    Accession Number: 20120806-5095.
    Comments Due: 5 p.m. ET 8/20/12.

    Docket Numbers: RP12-928-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: 2012-08-06 NC's (7) to be effective 8/7/2012.
    Filed Date: 8/6/12.
    Accession Number: 20120806-5131.
    Comments Due: 5 p.m. ET 8/20/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: August 7, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-19854 Filed 8-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Proposed Rules]
[Pages 22700-22703]
[FR Doc No: 2020-08156]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2020-0159; FRL-10008-16-Region 6]

Air Plan Approval; Texas; Construction Prior to Permit Amendment
Issuance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is proposing to approve a
revision to the Texas (TX) State Implementation Plan (SIP) proposed
January 29, 2020 and submitted for parallel processing by the State on
January 30, 2020. The proposal amends certain air quality permitting
rules located in Title 30 of the Texas Administrative Code (TAC),
Section 116, Control of Air Pollution by Permits for New Construction
or Modification. These revisions amend the State's New Source Review
permitting regulations via the addition of new, proposed Section
116.118, Construction While Permit Application Pending. This proposed
new section will allow applicants for certain permit amendments to
begin construction after the executive director has completed a
technical review and issued a draft permit including the permit
amendment for public review and comment, i.e., prior to final permit
issuance. Non-substantive, administrative-type, editorial changes, such
as grammar, re-lettering, and reference revisions and/or corrections
are also included in the revisions the EPA is proposing for approval.

DATES: Written comments must be received on or before May 26, 2020.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2020-0159, at https://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to

make. The EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e., on the web, cloud, or
other file sharing system). For additional submission methods, please
contact Elizabeth Layton,<PHONE_NUMBER><EMAIL_ADDRESS>For
the full EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at https://www.regulations.gov. While all documents in
the docket are listed in the index, some information may not be
publicly available due to docket file size restrictions or content
(e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Elizabeth Layton, EPA Region 6 Office,
Air Permits Section,<PHONE_NUMBER><EMAIL_ADDRESS>Out of an
abundance of caution for members of the public and our staff, the EPA
Region 6 office will be closed to the public to reduce the risk of
transmitting COVID-19. We encourage the public to submit comments via
https://www.regulations.gov, as there will be a delay in processing
mail and no courier or hand deliveries will be accepted. Please call or
email the contact listed above if you need alternative access to
material indexed but not provided in the docket.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

    Section 110(a)(2)(C) of the CAA requires states to develop and
submit to the EPA for approval into the SIP, preconstruction review and
permitting programs applicable to certain new and modified stationary
sources of air pollutants for attainment and nonattainment areas that
cover both major and minor new sources and modifications, collectively
referred to as the New Source Review (NSR) SIP. The CAA NSR SIP program
is composed of three separate programs: Prevention of Significant
Deterioration (PSD), Nonattainment New Source Review (NNSR), and Minor
NSR. The EPA codified minimum requirements for these State permitting
programs including public participation and notification requirements
at 40 CFR 51.160-51.164. Requirements for permitting of new stationary
sources and major modifications in attainment areas subject to PSD,
including additional public participation requirements, are found at 40
CFR 51.166. Requirements specific to construction of new stationary
sources and major modifications in nonattainment areas are codified in
40 CFR 51.165 for the NNSR program. Additionally, 40 CFR 51.160 through
51.163 outline the federal requirements which apply to minor permit
issuance, including the required administrative, public participation,
and federally enforceable procedures.
    On January 30, 2020, the Texas Commission on Environmental Quality
(TCEQ) submitted on behalf of the State of Texas, a letter \1\
requesting the parallel processing review of the January 29, 2020,
proposed amendments to 30 TAC Section 116, Control of Air Pollution by
Permits for New Construction or Modification, including proposed new
Section 116.118, Construction While Permit Application Pending. Under
the EPA's ``parallel processing'' procedure, the EPA proposes a
rulemaking action on a proposed SIP revision concurrently with State's
public review process. See 40 CFR 2.3 of Appendix V to part 51 for the
requirements and procedure for parallel processing. The January 30,
2020, SIP revision request will not meet all the SIP approvability
criteria and deemed complete until the State concludes the public
process and submits the final, adopted SIP revision with a letter from
the Governor or Governor's designee to the EPA. The EPA is proposing to
approve the January 29, 2020, proposed SIP revision upon completion of
the State public process and final submittal to the EPA. If the State's
proposed SIP revision is not significantly or substantively changed,
the EPA will finalize the rulemaking on the SIP revision as proposed
after responding to any relevant comments received on our rulemaking.
Final rulemaking action by the EPA will occur only after the final SIP
revision has been fully adopted by the TCEQ and submitted formally to
the EPA for approval as a revision to the Texas SIP. See 40 CFR
Appendix V to part 51.
---------------------------------------------------------------------------

    \1\ Please see January 30, 2020, letter addressed to the
Regional Administrator at the U.S. EPA, Region 6 requesting parallel
processing from TCEQ included in the docket to this rulemaking
action.
---------------------------------------------------------------------------

    This action addresses the January 29, 2020, proposed revisions to
the Texas SIP that amend the State's minor NSR permitting rules by
proposing the addition of new 30 TAC Section 116.118, Construction
While Permit Application Pending, which allows an applicant for a
permit amendment to begin construction, at their own risk, after the
executive director has completed a technical review and issued a draft
permit for public review and comment. Historically, the permit
applicant would not be able to begin construction until the final
permit was issued. As specified in the new rule, the applicant assumes
all risk when commencing construction under proposed new Section
116.118, and the applicant's investment (financial or otherwise) in any
construction activities commenced prior to final permit issuance is
prohibited from being used by the permitting authority as a factor when
making the determination to issue the applicant's requested amendment.
The new, proposed section does not allow for any pre-permit
construction prohibited by federal law.

II. The EPA's Evaluation

    On January 29, 2020, the TCEQ proposed revisions to the Texas SIP
(Rule Project No. 2019-129-116-AI) which revise their rules that
address the applicable requirements for air pollution control permits
for new construction or modification under 30 TAC Chapter 116, Sections
116.110, 116.116, 116.710, and 116.721; and the addition of proposed
new Section 116.118. These proposed revisions were submitted to the EPA
with a request for parallel processing on January 30, 2020. The
proposed revisions to 30 TAC Chapter 116 were partly in response to the
passage of House Bill (HB) 2726, 86th Texas Legislature, 2019. This
legislation revised Texas Health and Safety Code (THSC), Section
382.004, Construction While Permit Application Pending, to provide
applicants for permit amendments the option to begin construction after
the permitting authority has completed a technical review and issued
the draft permit, but prior to final permit issuance.
    The proposed January 29, 2020, revisions amend the Texas SIP at 30
TAC Subsections 116.110(a), 116.116(b), (e) and (f), 116.710(a),
116.721(a), and include the addition of new Section 116.118, comprised
of Subsections 116.118(a)(1)-(8), (b), and (c)(1)-(2). The proposed
revisions to Subsections 116.110(a), 116.116(b), 116.710(a) and
116.721(a) add a reference to proposed new Section 116.118 to include
the option to begin construction when a draft permit is issued. The
proposed revisions to Subsections 116.116(e)(2)(B), (D) and (E), and
(8)(A) are non-substantive, grammatical edits such as grammatical
number and case changes. The proposed revisions to Subsections
116.116(e)(3), 116.116(f) and 116.721(d)(1) are also non-substantive,
grammatical-type, editorial

changes intended to improve readability by replacing the word
``notwithstanding'' with ``regardless of.''
    The language in Section 116.110 regarding change in ownership,
submittal under seal of Texas licensed professional engineer and
responsibility for permit application, originally approved at
Subsections 116.110(d), (e) and (f), was part of a July 22, 1998,
submittal and subsequently approved into the SIP on November 14, 2003
(68 FR 64543). However, in a July 14, 2014, final action, regarding
revisions to the Texas NSR SIP addressing the Texas Minor NSR Flexible
Permits Program, the EPA made an error in our amendatory language
pertaining to 30 TAC Section 116.110 by excluding Subsection 116.110(d)
from the SIP (See 79 FR 40666). In the July 14, 2014, final rule, we
note the SIP approved version of 30 TAC Section 116.110 is the July 22,
1998, submission, which includes the aforementioned language at
Subsections (d), (e), and (f). Additionally, in 2002, the State
inserted new rule language at 116.110(c) regarding compliance history,
which is not included in SIP, but required the re-lettering of the
provisions listed above at Subsections 116.110(d), (e), and (f) to
Subsections 116.110(e), (f), and (g), respectively. This re-lettering
was adopted without changes by the State on August 23, 2002, but not
yet submitted for SIP action. The TCEQ requested the EPA address this
ministerial correction to the SIP and revise the table at 40 CFR
52.2270(c) to accurately reflect the inclusion of these provisions in
the SIP with their appropriate re-lettering in the January 30, 2020,
letter requesting the parallel processing of this proposed rulemaking
(letter is included in the docket for this proposed action).
    The addition of proposed new Section 116.118 allows an applicant to
begin construction at their own risk after the executive director has
completed the technical review process and issued a draft permit for
public review and comment in the purpose provisions at Subsection
116.118(a)(1). Subsections 116.118(a)(2)-(8) contain the proposed new
section's applicability requirements and exclusions. Subsection
116.118(a)(2) excludes concrete batch plants located within 880 yards
of property being used as a residence, from being eligible for pre-
permit construction under Section116.118. The applicability
requirements of the new, proposed section are bound by and only
authorize construction to the extent permissible under federal law.
Subsection 116.118(a)(3) specifies that projects subject to federal PSD
or NNSR permitting are not eligible for pre-permit construction under
Section 116.118. Subsections 116.118(a)(4) and 116.118(a)(5) specify
that Plant-wide Applicability (PAL) permits and projects triggering
case-by-case determination of Maximum Achievable Control Technology
(MACT) under the federal CAA Section 112(g), respectively, are not
eligible for pre-permit construction under proposed new Section
116.118. Subsection 116.118(a)(6) excludes qualified facility changes
implemented under Section 116.116(e) from the proposed pre-permit
construction provisions at Section 116.118. Subsection 116.118(a)(7)
specifies that requests, claims, registrations, or applications for a
standard permit under 30 TAC Chapter 116 Subchapter F (Standard
Permits) or permit by rule (PBR) under 30 TAC Chapter 106 (Permits by
Rule) are not eligible for pre-permit construction under proposed
Section 116.118. Subsection 116.118(a)(8) specifies that Section
116.118 does not relieve or exempt the applicant or project from any
other applicable state or federal requirements, including requirements
for public notice and participation, federal applicability, emission
control technology, and distance limitations. Compliance with the
public notice requirements at 30 TAC Chapter 39 is required in
Subsection 116.118(b) for any permit amendment applicant using the pre-
permit construction provisions in Section 116.118. Subsection
116.118(c)(1) clarifies that although Section 116.118 allows for pre-
permit construction for eligible projects, operation of a facility is
still strictly forbidden prior to final permit issuance. Subsection
116.118(c)(2) prohibits the State's permitting authority (TCEQ) from
considering investment (of any kind) made by the permit amendment
applicant in pre-permit construction under Section 116.118 as a factor
when making the determination to grant the permit amendment requested
in the application.
    As discussed in detail above, new proposed Section 116.118 allows
certain preconstruction activities prior to obtaining a final
construction permit, provided that specific conditions are met. The EPA
has preliminarily determined that proposed new Section 116.118,
allowing for construction to commence after the issuance of the draft
permit, but prior to final permit amendment issuance (under certain
conditions), is consistent with the requirements of CAA sections
110(a)(2)(C) and 110(l), and federal regulations at 40 CFR 51.160-
51.164, 51.165 and 51.166. Section 110(a)(2)(C) of the CAA requires
that state SIPs include a program for regulating the construction and
modification of stationary sources as necessary to ensure that the
NAAQS are maintained. Federal regulations at 40 CFR 51.160(b) require
states to have legally enforceable procedures to prevent the
construction or modification of a source if it would violate any SIP
control strategies or interfere with attainment or maintenance of the
NAAQS. The proposed revisions to the Texas NSR permitting rules under
proposed new Section 116.118 allow construction to commence only after
the State has conducted a comprehensive technical review of the
amendment application and issued a draft permit for public review and
comment. The permit amendment application must satisfy all applicable
requirements in the technical review process before the State issues
the draft permit and preliminary decision. The State's technical
analysis includes, but is not limited to, evaluating the emission
sources, confirming the applicant included air pollution control
measures, which are at least as stringent as best available control
technology (BACT), verifying the proposed emissions will not jeopardize
the NAAQS, and ensuring the application satisfies all state and federal
regulatory requirements. Therefore, the issuance of the draft permit
provides the State's demonstration that the permit amendment will not
jeopardize attainment or violate the NAAQS, thereby satisfying the
federal requirements located in sections 110(a)(2)(c) and 110(l) of the
Act, and the federal enforceability, public notice, responsible agency
identification, and administrative procedural requirements at 40 CFR
51.160-51.163. The proposed Texas regulations also expressly forbid
preconstruction activities that are not permissible under federal
law.\2\ Further, other states' rules allowing for commencement of
construction prior to final permit issuance where those rules applied
exclusively to minor NSR have been approved by the EPA. These include
the EPA's approval of analogous regulations into the Mississippi SIP on
July 10, 2006, and the West Virginia SIP on October 5, 2018 (See 71 FR
38773 and 83 FR 50266, respectively).
---------------------------------------------------------------------------

    \2\ See 40 CFR 51.165(a)(1)(xv), 51.166(b)(11), and
52.21(b)(11).
---------------------------------------------------------------------------

    The TCEQ's existing NSR permitting rules for both minor and major
sources are approved by the EPA into the SIP and the proposed revisions
to the State's minor NSR permit rules are consistent with the
requirements of the CAA and

EPA's regulations. When reviewing SIP submissions, the EPA's role is to
approve state choices provided they meet the criteria of the CAA, and
the applicable federal regulations pertaining to the specific submitted
revision(s) being acted on. The EPA has reviewed the proposed changes
to the Texas NSR regulations and preliminarily finds them to be
consistent with CAA sections 110(a)(2)(C) and 110(l), and the EPA's NSR
regulations located at 40 CFR 51.160-51.164.

III. Proposed Action

    The EPA has made the preliminary determination that the January 29,
2020, regulations proposed for adoption by the TCEQ, and submitted to
the EPA for parallel processing on January 30, 2020, as proposed
revisions to the Texas SIP and the State's minor NSR permit rules, are
in accordance with the CAA and the EPA's regulations, policy, and
guidance for NSR permitting. The EPA's analysis indicates the proposed
revisions to 30 TAC Section 116 satisfy the federal requirements for
air pollution control permits and will not cause or contribute to an
increase in the NAAQS; thus, will not interfere with attainment or
reasonable further progress. Therefore, pursuant to section 110(l) of
the CAA, the EPA proposes approval of the following revisions, proposed
on January 29, 2020, and submitted by the TCEQ on January 30, 2020 with
a request for parallel processing:
     Revisions to 30 TAC Section 116.110 (except for Sections
116.110(a)(5), (c) and (d) that are not part of the Texas SIP);
     Revisions to 30 TAC Section 116.116;
     Addition of 30 TAC Section 116.118;
     Revisions to 30 TAC Section 116.710;
     Revisions to 30 TAC Section 116.721.

Additionally, the EPA proposes a ministerial change to 40 CFR
52.2270(c) to clarify that 30 TAC Section 116.110 Subsections (d)
change in ownership, (e) submittal under PE seal, and (f)
responsibility for permit application were approved on November 14,
2003, and include their appropriate re-lettering to 30 TAC Subsections
116.110(e), (f), and (g), respectively, from the January 30, 2020,
parallel processing request.
    The EPA is proposing this action in parallel with the state's
rulemaking process. We cannot take a final action until the State
completes its rulemaking process, adopts its final regulations, and
submits these final adopted regulations as revisions to the Texas SIP.
If during the response to comments process, the State rule is changed
significantly from the proposed rule and the rule upon which the EPA
proposed, the EPA may have to withdraw our initial proposed rule and
re-propose based on the final SIP submittal.

IV. Incorporation by Reference

    In this action, we are proposing to include in a final rule
regulatory text that includes incorporation by reference. In accordance
with the requirements of 1 CFR 51.5, we are proposing to incorporate by
reference revisions to the Texas regulations as described in the
Proposed Action section above. We have made, and will continue to make,
these documents generally available electronically through
www.regulations.gov (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

V. 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 proposes to approve 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 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 CAA; 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 EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed 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).

List of Subjects in 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.

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

    Dated: April 14, 2020.
Kenley McQueen,
Regional Administrator, Region 6.
[FR Doc. 2020-08156 Filed 4-22-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Rules and Regulations]
[Pages 22907-22910]
[FR Doc No: 2023-07723]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 131

[Docket No. FDA-2000-P-0126 (Formerly Docket No. 2000P-0658)]

International Dairy Foods Association: Response to the Objections
and Requests for a Public Hearing on the Final Rule To Revoke the
Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard
for Yogurt

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; response to objections and denial of public
hearing requests; removal of administrative stay; final amendment.

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

SUMMARY: The Food and Drug Administration (FDA or we) published

a final rule entitled ``Milk and Cream Products and Yogurt Products;
Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt
and To Amend the Standard for Yogurt,'' on June 11, 2021 (the 2021
final rule). The International Dairy Foods Association (IDFA) objected
to the final rule's provision that yogurt have either a titratable
acidity of not less than 0.7 percent, expressed as lactic acid, or a pH
of 4.6 or lower before the addition of bulky flavoring ingredients. We
are denying IDFA's request for a public hearing with respect to this
objection and are issuing a final order to modify the final rule's
provision with respect to both pH and titratable acidity.

DATES: This order is effective April 14, 2023. The administrative stay
is lifted April 14, 2023. The compliance date is May 15, 2023.

ADDRESSES: You may submit objections and requests for a hearing on new
provisions added by this response to objections as follows. Please note
that late, untimely filed objections will not be considered. The
https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of May 15, 2023.
Objections received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2000-P-0126 for ``International Dairy Foods Association: Response
to the Objections and Denial of the Requests for a Public Hearing on
the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat
Yogurt and To Amend the Standard for Yogurt.'' Received objections,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We
will review this copy, including the claimed confidential information,
in our consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>, or Holli Kubicki,
Center for Food Safety and Applied Nutrition, Office of Regulations and
Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 341) directs the Secretary of Health and Human Services
(Secretary) to issue regulations fixing and establishing for any food a
reasonable definition and standard of identity whenever, in the
judgment of the Secretary, such action will promote honesty and fair
dealing in the interest of consumers. Under section 701(e)(1) of the
FD&C Act (21 U.S.C. 371(e)(1)), any action for the amendment or repeal
of any definition and standard of identity under section 401 of the
FD&C Act for any dairy product (e.g., yogurt) must begin with a
proposal made either by FDA under our own initiative or by petition of
any interested persons.
    In the Federal Register of June 11, 2021 (86 FR 31117), we issued a
final rule (the 2021 final rule) amending the definition and standard
of identity for yogurt ((Sec.  131.200) (21 CFR 131.200)) and revoking
the definitions and standards of identity for lowfat yogurt (21 CFR
131.203) and nonfat yogurt (21 CFR 131.206). This action was in
response, in part, to a citizen petition submitted by the National
Yogurt Association. The final rule modernized the yogurt standard to
allow for technological advances while promoting honesty and fair
dealing in the interest of consumers.
    The preamble to the final rule stated that the effective date of
the final rule would be July 12, 2021, except as to any provisions that
may be stayed by the filing of proper objections (86 FR 31117 at
31136). Pursuant to section 701(e) of

the FD&C Act, the final rule notified persons who would be adversely
affected by the final rule that they could file objections, specifying
with particularity the provisions of the final rule deemed
objectionable, stating the grounds therefor, and requesting a public
hearing upon such objections. We gave interested persons until July 12,
2021, to file objections and request a hearing on the final rule.
    The IDFA timely filed objections and requested a hearing with
respect to several provisions in the final rule (see Objections and
Request for Hearings submitted by Michael Dykes, DVM (IDFA objection),
President and Chief Executive Officer, IDFA, dated July 12, 2021, to
the Dockets Management Staff, Food and Drug Administration (Comment ID
FDA-2000-P-0126-0109). Section 701(e)(2) of the FD&C Act provides that,
until final action is taken by the Secretary, the filing of objections
operates to stay the effectiveness of those provisions to which the
objections are made.
    In the Federal Register of March 23, 2022 (87 FR 16394) we issued a
final rule providing clarification on which provisions of the 2021
final rule were stayed and which requirements of the previous final
rule that we issued in 1981 (46 FR 9924) (1981 final rule) are in
effect pending final action under section 701(e) of the FD&C Act. In
the Federal Register of December 15, 2022 (87 FR 76559), we published a
final rule (2022 final rule) denying IDFA's requests for a hearing with
respect to all but one of their objections. The 2022 final rule
provided modifications to certain provisions in the final rule and
announced that the stay of effectiveness of provisions for which
hearings were denied was lifted. We did not address IDFA's objection
and request for a hearing on the provision in Sec.  131.200(a) that
yogurt have either a titratable acidity of not less than 0.7 percent,
expressed as lactic acid, or a pH of 4.6 or lower before the addition
of bulky flavoring ingredients (hereinafter referred to as ``the
acidity requirement''). We addressed this objection and request for a
hearing in a proposed order, which we sent to IDFA under Sec.  12.24(d)
(21 CFR 12.24(d)) and posted to the docket for public review (Document
ID FDA-2000-P-0126-0129). FDA regulations provide that after the
Commissioner serves a proposed order denying a hearing, a person has 30
days after receipt of the proposed order to demonstrate that the
submission justifies a hearing (Sec.  12.24(d)). FDA did not receive
any response to the proposed order, and we are now issuing a final
order denying IDFA's request for a hearing on the acidity requirement
and amending the 2021 final rule with respect to this requirement.

II. Objection and Request for a Hearing on the Acidity Requirement

    The acidity requirement in Sec.  131.200(a) of the 2021 final rule
is comprised of two options: yogurt must either have a minimum
titratable acidity of 0.7 percent or a maximum pH of 4.6 before bulky
flavoring ingredients are added. IDFA objected to both of these
options, asserting that they are not practical and do not reflect
consumer taste preferences or current industry practice for yogurt
manufacturing. IDFA stated that the requirement will not promote
honesty and fair dealing in the interest of consumers. IDFA asserted
that the requirement should be a titratable acidity of not less than
0.6 percent, expressed as lactic acid, measured in the white mass of
the yogurt, or a pH of 4.6 or lower measured in the finished product
within 24 hours after filling. IDFA requested a hearing on the
following issues: (1) whether a requirement that titratable acidity or
pH be reached prior to the addition of bulky flavors in the
manufacturing process is consistent with the basic nature and essential
characteristics of yogurt; (2) whether a requirement that prohibits
yogurt from being filled at a pH of 4.8 or less and reaching a pH of
4.6 or below within 24 hours after filling is consistent with the basic
nature and essential characteristics of yogurt; and (3) whether a
minimum titratable acidity requirement of 0.7 percent is in the
interest of consumers and necessary to maintaining the basic nature and
essential characteristics of yogurt.
    We are denying IDFA's request for a hearing with respect to both
the titratable acidity minimum and pH maximum under Sec.  12.24(b)(1).
We are modifying the 2021 final rule with respect to the pH maximum in
accordance with IDFA's request, and we are modifying the 2021 final
rule to eliminate the option of complying with a minimum titratable
acidity.

A. Denial of Request for a Hearing on Maximum pH Option

    With respect to the maximum pH option, IDFA objected to requiring
the pH to be reached prior to the addition of bulky flavoring
ingredients and requiring the pH of 4.6 in the white mass of the yogurt
prior to filling. IDFA explained that modifications made to the Grade
``A'' Pasteurized Milk Ordinance (PMO) in 2007 exempted yogurt from
certain cooling requirements based on an initial pH of 4.8 or below at
filling and with the product reaching a pH of 4.6 or below within 24
hours of filling. (The PMO is a model regulation intended to help
States and municipalities initiate and maintain effective programs for
the prevention of milk-borne disease. State and local milk control
agencies can adopt the PMO.) IDFA stated that bulky flavoring
ingredients such as fruits and fruit preparations are added before
achieving the target pH (pH 4.6) and prior to filling. Before accepting
this change in the PMO, FDA and the National Conference on Interstate
Milk Shipments reviewed pathogen challenge study data regarding this
manufacturing practice and concluded that exempting yogurt from the
cooling requirements of the PMO is safe when this specific practice is
followed. In its objection, IDFA also asserted that such products
(manufactured with an initial pH of 4.8 or below at filling and with
the product reaching a pH of 4.6 or below within 24 hours of filling)
have been on the market for many years and accepted by consumers
without deviating from the basic nature and essential characteristics
of yogurt and maintaining honesty and fair dealing in the interest of
consumer.
    We agree that the key safety control measure for finished yogurt is
pH and, secondarily, temperature control (i.e., refrigeration). Also,
the pH process described in the PMO for yogurt contains other factors
that contribute to preventing growth of different kinds of
microorganisms. For example, the relatively rapid pH drop during
fermentation (and the final pH achieved) is the primary control measure
for pathogenic sporeformers in yogurt. Microbiological safety by acids
relies on the pH value of the food, and pH is a parameter that is
easily measurable. The pH values that inhibit growth of microbial
pathogens are generally well-known by food safety professionals and
easily found in the scientific literature.
    Based on all available information, including the information
presented in the objections from IDFA, FDA is amending the yogurt
standard regarding the acidity requirement in Sec.  131.200(a). We are
revising Sec.  131.200(a) as requested by IDFA, and consistent with the
PMO, to require a pH of 4.6 or lower measured on the finished product
within 24 hours after filling. The finished product refers to the
yogurt white mass after the addition of bulky flavors. If a bulky
flavor (e.g., fruit pieces) added to yogurt increases the pH, the pH
must be 4.6 or lower after the product has had time to equilibrate.
This requirement will ensure the safety

of yogurt, while maintaining its basic nature and essential
characteristics.
    This amendment is consistent with IDFA's proposed modification to
the maximum pH option. Therefore, we are denying IDFA's request for a
hearing with respect to the maximum pH option under Sec.  12.24(b)(1)
because there is not a genuine and substantial issue of fact for
resolution at a hearing.

B. Denial of Request for a Hearing on the Minimum Titratable Acidity
Option

    IDFA objected to the minimum titratable acidity of 0.7 percent and
requested that we modify the 2021 final rule to provide for a minimum
titratable acidity of 0.6 percent. IDFA explained that a minimum
titratable acidity of 0.6 percent is necessary to produce certain low
calorie yogurt products that meet consumer expectations of a delicate
and less tart yogurt taste that is not too acidic or sour. IDFA stated
that if a titratable acidity requirement of 0.7 percent is imposed,
some manufacturers may need to adjust formulations and add sugars to
counteract the acidity and deliver a product that meets consumer
expectations and preferences. IDFA emphasized that a minimum titratable
acidity of 0.6 percent would provide manufacturers with needed
flexibility.
    Because we are modifying the maximum pH option consistent with the
pH specifications in the PMO, which States have adopted, manufacturers
are already required to comply with the maximum pH option. Therefore,
the minimum titratable acidity option in the 2021 final rule, whether
set at 0.7 percent or 0.6 percent, is superfluous and would not provide
flexibility to manufacturers. So long as manufacturers comply with the
maximum pH option, they may manufacture yogurt with a titratable
acidity of 0.6 percent and can accommodate consumer expectations and
preferences without reformulating their products. We note that the
maximum pH option we are finalizing has been in effect in States for
several years and, by itself, appears sufficient to ensure the safety
of yogurt products. With the elimination of the titratable acidity
option, we are also removing Sec.  131.200(e)(1)(iii) Methods of
analysis, Titratable acidity and the corresponding method incorporated
by reference in Sec.  131.200(i)(1)(i).
    We are denying IDFA's request for a hearing on whether a minimum
titratable acidity requirement of 0.7 percent is in the interest of
consumers and necessary to maintaining the basic nature and essential
characteristics of yogurt. Given our modification to the maximum pH
option, a minimum titratable acidity option is unnecessary, and we do
not believe there is a genuine and substantial issue of fact for
resolution at a hearing (Sec.  12.24(b)(1)).

III. Conclusions

    For the reasons explained above, we are denying IDFA's request for
a hearing with respect to both the maximum pH option and the minimum
titratable acidity option under Sec.  12.24(b)(1). We are modifying the
acidity requirement in Sec.  131.200(a) in the 2021 final rule to
eliminate the minimum titratable acidity option and require that yogurt
have a pH of 4.6 or lower measured on the finished product within 24
hours after filling.
    This final order is being issued after following the process
provided under Sec.  12.24(d). Objections to or requests for hearing on
the modification and revocation may be submitted under 21 CFR 12.20
through 12.22 in accordance with 21 CFR 12.26. The stay of
effectiveness with respect to the acidity requirement is lifted upon
publication of this final order in the Federal Register.

IV. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. U.S. Department of Health and Human Services, Public Health
Service, Food and Drug Administration. Grade ``A'' Pasteurized Milk
Ordinance. 2019. Available at: https://ncims.org/wp-content/uploads/2020/07/2019-PMO.pdf (last accessed February 6, 2023).

List of Subjects in 21 CFR Part 131

    Cream, Food grades and standards, Milk, Yogurt.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
131 is amended as follows:

PART 131--MILK AND CREAM

0
1. The authority citation for part 131 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
2. In Sec.  131.200:
0
a. Revise the fourth sentence of paragraph (a);
0
b. Remove paragraphs (e)(1)(iii) and (i)(1)(i); and
0
c. Redesignate paragraphs (i)(1)(ii) and (iii) as paragraphs (i)(1)(i)
and (ii).
    The revision reads as follows:

Sec.  131.200  Yogurt.

    (a) * * * Yogurt contains not less than 3.25 percent milkfat,
except as provided for in paragraph (g) of this section, and not less
than 8.25 percent milk solids not fat and has a pH of 4.6 or lower
measured on the finished product within 24 hours after filling. * * *
* * * * *

    Dated: April 6, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-07723 Filed 4-13-23; 8:45 am]
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EPA
has released a series of reports that evaluate progress under the Clean Air
Interstate Rule (CAIR) in 2009 by examining emission reductions, reviewing
compliance results and market activity, and comparing changes in emissions to
changes in environmental indicators. The first report was released in September
2010, and will be followed by additional releases over the course of 2010.

Emission and
Compliance Data Report

Published September 2010

Emission,
Compliance, and Market Analyses

Published September 2010

Environmental
and Health Results

Published January 2011

Additional Data

Interactive
  Mapping

Data
  and Figures

About the Clean Air Interstate Rule

The Clean Air
Interstate Rule (CAIR) was designed to address interstate transport of ozone
and fine particulate matter (PM2.5) pollution. To do so, CAIR required certain states to limit annual emissions of
nitrogen oxides (NOX) and sulfur dioxide (SO2), which
contribute to the formation of ozone and PM2.5. It also required
certain states to limit ozone season NOX emissions which contribute
to the formation of ozone during the summer ozone season. CAIR developed three separate cap and
trade programs that could be used to achieve the required reductions — the
CAIR NOX ozone season trading program, the
CAIR annual NOX trading program, and the
CAIR SO2 trading program. The CAIR NOX ozone season and annual programs began in
2009, while the CAIR SO2 annual program began
in 2010. The reduction in ozone and PM2.5 formation resulting from
implementation of the CAIR programs provides health
benefits as well as improved visibility in national parks and improved stream
quality in the eastern U.S.

Litigation and the CAIR Replacement
Rule

On July 11, 2008, the U.S. Court of Appeals for the D.C. Circuit issued a
ruling vacating CAIR in its entirety. EPA and other parties requested a rehearing, and on December
23, 2008, the Court revised its decision and remanded CAIR to EPA without vacatur. This
ruling leaves CAIR and the CAIR
Federal Implementation Plans (FIPs) — including the CAIR
trading programs — in place until EPA issues new rules
to replace CAIR.

EPA is committed to issuing rules to replace CAIR that will help states address the interstate air
emissions transport problem in a timely way and that fully comply with the
requirements of the Clean Air Act and the opinions of the D.C. Circuit. EPA has developed a proposed Transport Rule which, if finalized as
proposed, would replace CAIR in 2012. The proposed rule
was signed in July 2010.

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