[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2943-2945]
[FR Doc No: 2015-00761]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0500]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Requirements on Content and Format of Labeling for
Human Prescription Drug and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of

information, including each proposed extension of an existing
collection of information, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on the
information collection provisions of FDA's requirements on content and
format of labeling for human prescription drug and biological products.

DATES: Submit either electronic or written comments on the collection
of information by March 23, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products (OMB Control Number 0910-0572)--Extension

    FDA's regulations governing the format and content of labeling for
human prescription drug and biological products were revised in the
Federal Register of January 24, 2006 (71 FR 3922), to require that the
labeling of new and recently approved products contain highlights of
prescribing information, a table of contents for prescribing
information, reordering of certain sections, minor content changes, and
minimum graphical requirements. These revisions were intended to make
it easier for health care practitioners to access, read, and use
information in prescription drug labeling; to enhance the safe and
effective use of prescription drug products; and to reduce the number
of adverse reactions resulting from medication errors due to
misunderstood or incorrectly applied drug information.
    Currently, Sec.  201.56 (21 CFR 201.56) requires that prescription
drug labeling contain certain information in the format specified in
either Sec.  201.57 (21 CFR 201.57) or Sec.  201.80 (21 CFR 201.80),
depending on when the drug was approved for marketing. Section
201.56(a) sets forth general labeling requirements applicable to all
prescription drugs. Section 201.56(b) specifies the categories of new
and more recently approved prescription drugs subject to the revised
content and format requirements in Sec. Sec.  201.56(d) and 201.57.
Section 201.56(c) sets forth the schedule for implementing these
revised content and format requirements. Section 201.56(e) specifies
the sections and subsections, required and optional, for the labeling
of older prescription drugs not subject to the revised format and
content requirements.
    Section 201.57(a) requires that prescription drug labeling for new
and more recently approved prescription drug products include
``Highlights of Prescribing Information''. Highlights provides a
concise extract of the most important information required under Sec.
201.57(c) (the Full Prescribing Information (FPI)), as well as certain
additional information important to prescribers. Section 201.57(b)
requires a table of contents to prescribing information, entitled
``Full Prescribing Information: Contents,'' consisting of a list of
each heading and subheading along with its identifying number to
facilitate health care practitioners' use of labeling information.
Section 201.57(c) specifies the contents of the FPI. Section 201.57(d)
mandates the minimum specifications for the format of prescription drug
labeling and establishes minimum requirements for key graphic elements
such as bold type, bullet points, type size, and spacing.
    Older drugs not subject to the revised labeling content and format
requirements in Sec.  201.57 are subject to labeling requirements at
Sec.  201.80. Section 201.80(f)(2) requires that within 1 year, any
FDA-approved patient labeling be referenced in the ``Precautions''
section of the labeling of older products and either accompany or be
reprinted immediately following the labeling.
    Annual Burden for Prescription Drug Labeling Design, Testing, and
Submitting to FDA for New Drug Applications (NDAs) and Biologics
License Applications (BLAs) (Sec. Sec.  201.56 and 201.57). New drug
product applicants must: (1) Design and create prescription drug
labeling containing ``Highlights'', ``Contents'', and FPI, (2) test the
designed labeling (e.g., to ensure that the designed labeling fits into
carton-enclosed products), and (3) submit it to FDA for approval. Based
on the projected data used in the January 24, 2006, final rule, FDA
estimates that it takes applicants approximately 3,349 hours to design,
test, and submit prescription drug labeling to FDA as part of an NDA or
a BLA under the revised regulations. Currently, approximately 131
applicants submit approximately 196 new applications (NDAs and BLAs) to
FDA annually, totaling 656,404 hours.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
           21 CFR Part               Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Labeling Requirements in Sec.                131             1.5             196           3,349         656,404
 Sec.   201.56 and 201.57.......
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    \1\ There are no capital costs or operating and maintenance
costs associated with this collection of information.

    Dated: January 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00761 Filed 1-20-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 93 (Monday, May 17, 2021)]
[Proposed Rules]
[Pages 26682-26685]
[FR Doc No: 2021-10230]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0368; Project Identifier MCAI-2021-00204-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus SAS Model A318, A319, A320, and A321 series airplanes.
This proposed AD was prompted by reports of low halon concentration in
the forward and aft cargo compartments due to air leakage through cargo
door seals, and the certification of improved cargo door seals. This
proposed AD would require replacing the forward, aft, and bulk cargo
compartment door seals with new seals; and installing a placard on the
forward, aft, and cargo compartment doors; and for certain airplanes,
implementing an operational limitation for certain routes, as specified
in a European Union Aviation Safety Agency (EASA) AD, which is proposed
for incorporation by reference. The FAA is proposing this AD to address
the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by July 1,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0368.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0368; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0368; Project Identifier
MCAI-2021-00204-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Sanjay Ralhan, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0049, dated February 18, 2021
(EASA AD 2021-0049) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus SAS Model A318-111, -112, -121, and -122; A319-111, -
112, -113, -114, -115, -131, -132, -133, -151N, -153N, and -171N; A320-
211, -212, -214, -215, -216, -231, -232, -233, -251N, -252N, -253N, -
271N, -272N, and -273N; and A321-111, -112, -131, -211, -212, -213, -
231, -232, -251N, -252N,

-253N, -271N, -272N, -251NX, -252NX, -253NX, -271NX, and -272NX
airplanes. Model A320-215 airplanes are not certificated by the FAA and
are not included on the U.S. type certificate data sheet; this AD
therefore does not include those airplanes in the applicability.
    This proposed AD was prompted by reports of low halon concentration
in the forward and aft cargo compartments due to air leakage through
cargo door seals, and the certification of improved cargo door seals.
The FAA is proposing this AD to address low halon concentration, which
could affect the fire extinguishing system efficiency in the cargo
compartments and possibly result in failure of the system to contain a
cargo compartment fire. See the MCAI for additional background
information.

Relationship Between This Proposed AD and AD 2020-16-01

    This NPRM would not supersede AD 2020-16-01, Amendment 39-21185 (85
FR 47013, August 4, 2020) (AD 2020-16-01). Rather, the FAA has
determined that a stand-alone AD would be more appropriate to address
the changes in the MCAI. This NPRM would require replacing the forward,
aft, and bulk cargo compartment door seals with new seals; and
installing a placard on the forward, aft, and bulk cargo compartment
doors; and for certain airplanes, implementing an operational
limitation for certain routes. Accomplishment of the proposed actions
would then terminate all requirements of AD 2020-16-01 for forward and
aft cargo door seals having part number (p/n) D5237106020000,
D5237106020200, D5237106020400, D5237300120000, or D5237300120200; and
bulk cargo door seals having p/n D5237200220000 or D5237200220200 only.
AD 2020-16-01 also addresses paragraphs (1) and (2) of EASA AD 2021-
0049, and forward and aft cargo door seals p/n D5237106020400S,
approved under parts manufacturer approval (PMA) PQ1715CE. This AD does
not address p/n D5237106020400S, approved under PMA PQ1715CE. The FAA
is considering additional rulemaking to require replacement of p/n
D5237106020400S, approved under PMA PQ1715CE.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0049 describes procedures for replacing the forward,
aft, and bulk cargo compartment door seals with new seals; and
installing a placard on the forward, aft, and bulk cargo compartment
door. For certain airplanes, EASA AD 2021-0049 describes procedures for
implementing an operational limitation prohibiting flying the airplane
over a route having a diversion time of more than 60 minutes. This
material is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0049 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.
    EASA AD 2021-0049 specifies amending the Aircraft Flight Manual
(AFM) and ``operating that aeroplane accordingly.'' However this AD
would not include a requirement for ``operating that aeroplane
accordingly'' as that action is already required by existing FAA
operating regulations. FAA regulations require pilots to follow the
procedures in the existing AFM including all updates. 14 CFR 91.9
requires that any person operating a civil aircraft must comply with
the operating limitations specified in the AFM. Therefore, including a
requirement in this AD to operate the airplane according to the revised
AFM would be redundant and unnecessary. Further, compliance with such a
requirement in an AD would be impracticable to demonstrate or track on
an ongoing basis; therefore, a requirement to operate the airplane in
such a manner would be unenforceable.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2021-0049
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2021-0049 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2021-0049 that is required for compliance with EASA AD 2021-
0049 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0368 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 1,728 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
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            Labor cost                    Parts cost          Cost per product        Cost on U.S.  operators
----------------------------------------------------------------------------------------------------------------
Up to 11 work[dash]hours x $85 per  Up to $6,760.........  Up to $7,695.........  Up to $13,296,960.
 hour = Up to $935.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus SAS: Docket No. FAA-2021-0368; Project Identifier MCAI-2021-
00204-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by July 1, 2021.

(b) Affected ADs

    This AD affects AD 2020-16-01, Amendment 39-21185 (85 FR 47013,
August 4, 2020) (AD 2020-16-01).

(c) Applicability

    This AD applies to all Airbus SAS airplanes specified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, -133, -
151N, -153N, and -171N airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N, -
252N, -253N, -271N, -272N, and -273N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -252N, -253N, -271N, -272N, -251NX, -252NX, -253NX, -271NX,
and -272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection; 52, Doors.

(e) Reason

    This AD was prompted by reports of low halon concentration in
the forward and aft cargo compartments due to air leakage through
cargo door seals, and the certification of improved cargo door
seals. The FAA is issuing this AD to address low halon
concentration, which could affect the fire extinguishing system
efficiency in the cargo compartments and possibly result in failure
of the system to contain a cargo compartment fire.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0049, dated February 18, 2021 (EASA AD 2021-0049).

(h) Exceptions to EASA AD 2021-0049

    (1) Where EASA AD 2021-0049 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0049 do not apply to this AD; FAA AD 2020-16-01 addresses
those requirements.
    (3) Where paragraph (4) of EASA AD 2021-0049 specifies amending
the Aircraft Flight Manual (AFM) and ``operating that aeroplane
accordingly,'' this AD does not include a requirement for
``operating that aeroplane accordingly'' as that action is already
required by existing FAA operating regulations.
    (4) Paragraph (4) of EASA AD 2021-0049 specifies amending ``the
Aircraft Flight Manual (AFM) of the aeroplane by inserting a copy of
this AD,'' however, this AD requires amending ``the existing AFM and
applicable corresponding operational procedures.''
    (5) The ``Remarks'' section of EASA AD EASA AD 2021-0049 does
not apply to this AD.
    (6) The provisions specified in paragraphs (5) and (6) of EASA
AD 2021-0049 do not apply to this AD.

(i) Terminating Action for AD 2020-16-01

    Accomplishing the actions required by this AD for the affected
parts defined in EASA AD 2021-0049 terminates all requirements of AD
2020-16-01 for forward and aft cargo door seals having part number
(p/n) D5237106020000, D5237106020200, D5237106020400,
D5237300120000, or D5237300120200; and bulk cargo door seals having
p/n D5237200220000 or D5237200220200 only.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k)(2) of
this AD. Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2021-0049 that contains RC procedures and
tests: Except as required by paragraph (j)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be

done and the airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(k) Related Information

    (1) For information about EASA AD 2021-0049, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>Internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu.at You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-0368.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on May 11, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-10230 Filed 5-14-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Notices]
[Pages 59205-59206]
[FR Doc No: 2016-20627]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-2456-000]

Emera Energy Services Subsidiary No. 12 LLC; Supplemental Notice
That Initial Market-Based Rate Filing Includes Request for Blanket
Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Emera Energy Services Subsidiary No. 12 LLC`s application for market-
based rate authority, with an accompanying rate tariff, noting that
such application includes a request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 12, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed

docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 23, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-20627 Filed 8-26-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Page 42974]
[FR Doc No: 2020-15234]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-23]

Petition for Exemption; Summary of Petition Received; High Tide
Aviation

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

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 4, 2020.

ADDRESSES: Send comments identified by docket number FAA-2019-0952
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Brittany Newton,<PHONE_NUMBER>,
Office of Rulemaking, Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on July 9, 2020.
Brandon Roberts,
Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2019-0952.
    Petitioner: High Tide Aviation.
    Section(s) of 14 CFR Affected: Sec.  135.297(d).
    Description of Relief Sought: High Tide Aviation currently operates
the King Air C-90 aircraft and requests an exemption from Sec.
135.297(d) to permit a pilot to conduct semi-annual Instrument
Proficiency Check Requirements concurrently with a King Air BE-200
Recurrent Training Course with Differences Training for the King Air C-
90 in a full motion BE-200, Level-C flight simulator in substitution of
conducting the required Instrument Proficiency Check Requirements in
the actual aircraft.

[FR Doc. 2020-15234 Filed 7-14-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36318-36320]
[FR Doc No: 2014-14924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0797]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary
Audit Report Submission Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with the Medical Device ISO 13485:2003 Voluntary Audit
Report Submission Pilot Program.

DATES: Submit either electronic or written comments on the collection
of information by August 25, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report
Submission Pilot Program--(OMB Control Number 0910-0700)--Extension

    Under section 228 of the Food and Drug Administration Amendments
Act of 2007 (Pub. L. 110-85), as amended by section 704(g)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(7)), the owner
or operator of an establishment may submit an audit report that
assesses conformance with appropriate quality system standards set by
the International Organization for Standardization (ISO) and identified
by the Secretary in public notice.
    The ``Guidance for Industry, Third Parties and FDA Staff: Medical
Device ISO 13485:2003 Voluntary Audit Report Submission Program''
describes how FDA's Center for Devices and Radiological Health and
Center for Biologics Evaluation and Research are implementing this
provision of the law and providing public notice as required. The
proposed collections of information are necessary to satisfy the
previously mentioned statutory requirements for implementing this
voluntary submission program. The collected information is used for
setting risk-based inspectional priorities.
    The ``Guidance for Industry, Third Parties, and FDA Staff: Medical
Device ISO 13485:2003 Voluntary Audit Report Submission Program''
describes how FDA's Center for Devices and

Radiological Health and Center for Biologics Evaluation and Research
are implementing this provision of the law and providing public notice
as required. The proposed collections of information are necessary to
satisfy the previously mentioned statutory requirements for
implementing this voluntary submission program.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                             Number of       Number of     Total annual       Average                      operating and
                        Activity                            respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
(One time only burden) First year, electronic setup and            1,700               1           1,700          \2\ 42          71,400         $51,000
 verification certificate \1\...........................
(Recurring burden) Audit report submission..............           1,700               1           1,700               3           5,100          51,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this information collection.
\2\ Respondent may already have a valid WebTrader account established for other FDA electronic submissions.

    Based on FDA's experience with the founding regulatory members of
the Global Harmonization Task Force (GHTF), FDA expects that the vast
majority of manufacturers who will participate in the Voluntary Audit
Report Submission Program will be manufacturers who are certified by
Health Canada under ISO 13485:2003.
    In addition, FDA only expects firms that do not have major
deficiencies or observations in their ISO 13485:2003 audits to be
willing to submit their audit reports to FDA under the Voluntary Audit
Report Submission Program. FDA analyzed its inspection data from Fiscal
Year (FY) 2013 (October 1, 2012 to October 1, 2013) and determined that
the total number of inspections finalized in FY 2013 for medical
devices was 2,404. The breakdown for the 2,404 compliance decisions is
as follows:

                  Table 2--Compliance Decisions FY 2013
------------------------------------------------------------------------
                                                            Approximate
           Compliance decision                Number        percentage
------------------------------------------------------------------------
Official Action Indicated...............             169               7
Voluntary Action Indicated..............             902              38
No Action Indicated.....................           1,083              45
Pending Final Decision..................             249              10
------------------------------------------------------------------------

    Because FDA only expects firms who do not have major deficiencies
or observations to be willing to submit their audit reports to FDA
under the Voluntary Audit Report Submission Program, FDA only expects
to receive audit reports that would have been classified by FDA as No
Action Indicated (NAI).
    Assuming that the percentage breakdown of compliance decisions for
all inspections conducted in FY 2013 can be extrapolated and applied to
audits of manufacturers certified under ISO 13485:2003 by Health
Canada, FDA can estimate the number of Canadian establishments that
would have had an inspection classified as an NAI. Because 45 percent
of all compliance decisions resulted in an NAI decision, FDA estimates
that 1,546 of the facilities certified under ISO 13485:2003 by Health
Canada (45 percent of the total 3,436 facilities) would have had an
inspection classified as an NAI.
    Because FDA expects that the vast majority of manufacturers who
will participate in the Voluntary Audit Report Submission Program will
be manufacturers certified by Health Canada under ISO 13485:2003, FDA
expects the number of reports to be submitted from manufacturers
certified by regulatory systems established by other founding GHTF
members to be minimal. For purposes of calculating the reporting
burden, FDA estimates that approximately 10 percent of total audit
reports submitted under this program will be from these other
manufacturers. Because 90 percent of the audit reports are expected to
be submitted by manufacturers certified by Health Canada (approximately
1,500 audit reports), the total number of audit reports FDA expects to
receive in a year is approximately 1,700 audit reports.
    FDA estimates from past experience with the Electronic Submission
Gateway system, WebTrader, that the first year to set up the account
and to receive the verification certificate takes approximately 40
hours. This burden may be minimized if the respondent already has an
established account in WebTrader for other electronic submissions to
FDA, but FDA is assuming that all respondents to this new pilot program
will be setting up a WebTrader account for the first time in the first
year. For subsequent years, the burden hours are estimated at 1 hour to
renew the yearly required verification certification.
    FDA further estimates that the gathering, scanning, and submission
of the audit reports, certificates, and related correspondence would
take approximately 2 hours utilizing the eSubmitter system.
    Therefore, the first year will include 40 hours for the WebTrader
system plus 2 hours for the eSubmitter submission process, resulting in
42 hours per response for the first year. For subsequent years, it is
estimated that only 1 hour will be necessary for the WebTrader system
plus the 2 hours for the eSubmitter submission process, resulting in 3
hours per response each year thereafter.
    There are operating and maintenance costs associated with this
information collection. The costs are $30 per year to establish and
maintain the Electronic Submission Gateway verification certificate.
    This guidance also refers to previously approved collections of
information found in FDA regulations. These collections of information
are

subject to review by OMB under the PRA. The collections of information
in 21 CFR part 820 have been approved under OMB control number 0910-
0073, and the collections of information for the Inspection by
Accredited Persons Program have been approved under OMB control number
0910-0569.

    Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14924 Filed 6-25-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Rules and Regulations]
[Pages 60366-60368]
[FR Doc No: 2020-20653]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0324; FRL-10013-33]

Trichoderma asperellum, Strain T34; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Trichoderma asperellum, strain T34 in or
on all food commodities when used in accordance with label directions
and good agricultural practices. Biocontrol Technologies S.L. submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of Trichoderma asperellum, strain T34 under FFDCA
when used in accordance with this exemption.

DATES: This regulation is effective September 25, 2020. Objections and
requests for hearings must be received on or before November 24, 2020,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0324, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0324 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 24, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0324, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
78), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 9F8735) by Biocontrol Technologies, S.L. Avgda. Madrid,
215-217, entres[ograve]l A 08014 Barcelona, Spain (c/o Wagner
Regulatory Associates, Inc., P.O. Box 640, Hockessin, DE 19707). The
petition requested that 40 CFR part 180 be amended by establishing an
exemption from the requirement of a tolerance for residues of
Trichoderma asperellum, strain T34 in or on all food commodities. That
document referenced a summary of the petition prepared by the
petitioner Biocontrol Technologies, S.L., which is available in the
docket via http://www.regulations.gov. There were no comments received
in response to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a

reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Pursuant to FFDCA section 408(c)(2)(B), in making a safety
determination to establish an exemption from the requirement of a
tolerance, EPA must take into account the factors set forth in FFDCA
section 408(b)(2)(C), which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance exemption and to ``ensure that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residue. . . .''
Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider
``available information concerning the cumulative effects of [a
particular pesticide's] residues and other substances that have a
common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on
Trichoderma asperellum, strain T34 and considered its validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on that data can be found
within the document entitled ``Federal Food, Drug, and Cosmetic Act
(FFDCA) Safety Determination for Trichoderma asperellum, strain T34.''
This document, as well as other relevant information, is available in
the docket for this action as described under ADDRESSES.
    The available data demonstrated that, with regard to humans,
Trichoderma asperellum, strain T34 is not toxic, pathogenic, or
infective via any reasonably foreseeable route of exposure. The
submitted acute oral toxicity/pathogenicity and acute pulmonary
toxicity/pathogenicity studies demonstrated no signs of toxicity,
infectivity, or pathogenicity. Although the first submitted acute
injection toxicity/pathogenicity study caused mortality to the test
animals, the mortality was attributed to high spore concentration, not
due to toxin production, as demonstrated by data and information
required by EPA to address the mortality. A second injection toxicity/
pathogenicity study was performed at a lower dose and only two of the
24 test animals died. Additional acute injection toxicity/pathogenicity
studies were required as a term of registration to address a concern
relating to culture filtrates and killed cultures. The studies
demonstrated no toxicity to the test animals when injected with either
Trichoderma asperellum, strain T34 spores or culture filtrate.
Furthermore, acute oral, dermal, and inhalation toxicity studies and
acute eye and primary dermal irritation studies conducted with a
mixture containing Trichoderma asperellum, strain T34 demonstrated no
toxic or irritant effects. Although there may be dietary and non-
occupational exposure to residues of Trichoderma asperellum, strain T34
when it is used on food commodities, there is not a concern due to the
lack of potential for adverse effects. EPA also determined that
retention of the Food Quality Protection Act safety factor was not
necessary as part of the qualitative assessment conducted for
Trichoderma asperellum, strain T34.
    Based upon its evaluation, EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to residues of
Trichoderma asperellum, strain T34. Therefore, an exemption from the
requirement of a tolerance is established for residues of Trichoderma
asperellum, strain T34 in or on all food commodities when used in
accordance with label directions and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required
because EPA has determined that reasonably foreseeable exposure to
residues of Trichoderma asperellum, strain T34 from use of the
pesticide will be safe, due to lack of toxicity, pathogenicity, and
infectivity. Under those circumstances, it is unnecessary to have an
analytical method to monitor for residues.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
et seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 2, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1379 to subpart D to read as follows:

Sec.  180.1379  Trichoderma asperellum, strain T34; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Trichoderma asperellum, strain T34 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2020-20653 Filed 9-24-20; 8:45 am]
BILLING CODE 6560-50-P


Male and Female Pubertal Protocols:

Identifying Environmental Compounds That Alter The Thyroid axis T. Stoker Endocrinology Branch, RTD NHEERL, ORD U. S. EPA, RTP, NC Applicability Detects compounds that display:

anti thyroid Estrogenic androgenic or anti androgenic altered puberty via changes in FSH, LH, PRL,

GH or hypothalamic function.

anti estrogenic [ estrogen receptor ( ER)]

steroid enzyme mediated activity Male and Female Pubertal Protocols Questions

Are the male and female pubertal assays useful as screens for thyrotoxicants with different mechanisms of action?

Are results reliable?

  What is Interlaboratory variability? Overview

Mechanisms of altered thyroid homeostasis.

Examples of chemicals with specific mechanisms.

Contract study results for PB and PTU   What was observed   Published studies vs. current data.

New studies looking at other thyrotoxicants ( EPA, ORD) MECHANISMS OF ALTERED THYROID HOMEOSTASIS

Clearance of thyroid hormones ( ex. liver enzyme induction or altered TTR/ TBG)

Synthesis of thyroid hormones ( ex. altered thyroperoxidase or altered uptake of iodine into the thyroid cell)

Tissue deiodinase ( peripheral conversion of T4> T3, FD & C Red No. 3, others?)

Receptor Binding (?? known)

Brain/ hypothalamic control of TRF ( not known ??) Liver T4 Gluc Biliary Excretion Blood/ Plasma Free TH Bound TH TTR/ TBG Brain Pituitary Thyroid TRH TSH + + T3, T4 T3, T4 Tissue deiodinase T4 > T3 T4 UDPGTs Iodine Perchlorate T4 T3 T4 Thyroperoxidase I + tyrosine T3 & T4 PTU Mancozeb PBDE Phenobarbitol PCBs Mechanisms of Thyroid Disruption FD& C Red No. 3 Alachlor DDT Altered Synthesis Altered Thyroid Synthesis

By altered KI symporter   Perchlorate 0 1 2 3 4 5 6 Control 62.5 mg/ kg 125 mg/ kg 250 mg/ kg 500 mg/ kg Total Serum T4 (

ug/

dl) Treatments *

*

* 0 0.5 1 1.5 2 2.5 3 3.5 Control 62.5 mg/ kg 125 mg/ kg 250 mg/ kg 500 mg/ kg Serum TSH (

ng/

ml) Treatments *

EPA, RTP Wistar female Altered Synthesis of T4

By inhibition of thyroperoxidase   PTU Control PTU240 0 1 2 3 4 5 6 7 8 T4 (

ug/

dl) Control PTU240 0 5 10 15 20 25 TSH (

ng/

ml) Control PTU240 0 10 20 30 40 50 60 70 80 Thyroid WT (

g)

Marty et al.,

Tox. Sci., 2001) Male CD Altered Clearance of T4 Altered Clearance of T4

Phenobarbital in Pubertal Male Marty et al.,

Tox. Sci., 2001 Male CD 0 2 4 6 8 10 12 14 Control 50 PB 100PB Liver Wt.(

g) * 0 10 20 30 40 50 60 70 Control 50PB 100PB 240PTU Thyroid Wt.

(

mg)

0 5 10 15 20 25 Control 50PB 100PB 240PTU TSH (

ng/

ml) 0 1 2 3 4 5 6 7 8 Control 50PB 100PB 240PTU T4 (

ug/

dl) *

*

* Pubertal Assays Detecting Thyroid Toxicants

Mechanism Identified by Assay( s)

  Altered KI symporter   Altered thyroperoxidase activity   Altered clearance of T4

Mechanisms not studied to date   Binding proteins ( organochlorines, like OH PCBs)

  Deiodinase ( FD& C Red No. 3)

  Hypothalamic alterations Results from Contract Studies

Contract I, 2000 ( PTU)

  Thyroid Hormones

Contract II, 2003 ( PB)

  Thyroid Weights

Contract III, 2003 ( PTU & PB)

  Thyroid Hormones, Weights and Histology 16.5 16.9 16.8 17.7 18.1 20 17.2 18.5 16.9 Oil EE0025 EE005 PB25 PB50 PB100 MET 12.5 MET 25 MET 50 15 16 17 18 19 20 21 22 THYROID WEIGHT **

Contract Study II 2003 Effect of chemicals on Thyroid Weights in Female Pubertal 21.6 21.2 20.4 20.4 21.9 23.2 19.3 21.9 21 Oil F25 F50 PB25 PB50 PB100 V10 V30 V100 16 18 20 22 24 THYROID WEIGHT ( g) NS Contract Study II 2003 The effect of chemicals on thyroid weight in the Male Pubertal 19.3 16.2 16.1 15.4 15.1 14.9 16.8 14.3 12.6 13.4 14.7 14.4 38.5 62 Con A Atrazine 75 Atrazine 150 Fenarimol 50 Fenarimol 250 Methoxychlor 25 Methoxychlor 50 Con B BPA 400 BPA 600 Ketoconazole 50 Ketoconazole 100 PTU 2 PTU 25 0 10 20 30 40 50 60 70 THYROID Wt * * * ** **

Contract Study III 2003 The effect of chemicals on thyroid weight in the Female Pubertal 20.5 18.6 88.6 24.2 18 .5 22 24.3 19.8 20.6 21 16.8 27.3 77 26.6 26.7 29.4 31.9 32.5 Con a ATR 75 ATR 150 p,

p'DDE 50 p,

p'DDE 100 Vin 30 Vin 100 Met 25 Met 50 Con b PTU 2 PTU 25 Keto 50 Keto 100 Linuron 50 Linuron 100 PB 50 PB 100 15 20 25 30 35 ** *

*

**

*

Contract Study III 2003 The Effect of Chemicals on Thyroid Weight in the Male Pubertal. 0 1 2 3 4 5 6 7 T4 ug/ dl LE> SD BUT NO INTERACTION WITH TR LE SD Oil KETOMT DBP FL PTU PIM 6.54 5.88 6 3.45 5.97 0.6 5.58 4.87 5.16 4.15 3.86 4.14 0 4.98 0 5 10 15 20 25 30 TSH ng/ ml LE SD Oil KETOMT DBP FL PTU PIM 3.13 2.86 2.72 2.11 4.16 26.2 2.1 3.06 2.98 2.67 2.43 2.36 27.7 2.68 * ** **

Contract Study I 2000 The effect of chemicals on thyroid hormones in the Male Pubertal 0 1 2 3 4 5 6 T4 ug/ dl Oil KETO MET EE TAM PTU PIM 4.12 3.71 4.01 4.3 5.51 0.03 3.34 1 10 100 TSH ng/ ml Oil KETO MET EE TAM PTU PIM 1.58 1.57 1.33 1.66 2 28.2 1.32 ** ** **

Contract Study I 2000 The effect of chemicals on thyroid hormones in the Female Pubertal 4.444.554.674.72 3.73 4.574.69 4.814.88 5.23 4.97 4.79 1.97 0.66 Con A Atrazine 75 Atrazine 150 Fenarimol 50 Fenarimol 250 Methoxychlor 25 Methoxychlor 50 Con B BPA 400 BPA 600 Ketoconazole 50 Ketoconazole 100 PTU 2 PTU 25 0 1 2 3 4 5 6 T4 9.629.9 8.52 19.7 12.5 8.349.83 7.88 6.977.518.92 8.24 42.4 99.4 Con A Atrazine 75 Atrazine 150 Fenarimol 50 Fenarimol 250 Methoxychlor 25 Methoxychlor 50 Con B BPA 400 BPA 600 Ketoconazole 50 Ketoconazole 100 PTU 2 PTU 25 0 20 40 60 80 100 120 TSH ** ** **

** **

*

Contract Study III 2003 The effect of chemicals on thyroid hormones in the Female Pubertal. 6.35 6.28 0.37 3.4 6.46 5.9 5.32 4.87 4.28 6.11 6.66 5.78 0.53 5.58 5.65 4.6 5.66 5.73 Con a ATR 75 ATR 150 p,

p'DDE 50 p,

p'DDE 100 Vin 30 Vin 100 Met 25 Met 50 Con b PTU 2 PTU 25 Keto 50 Keto 100 Linuron 50 Linuron 100 PB 50 PB 100 0 1 2 3 4 5 6 7 T4 10.9 12.7 135 9.49 10.95 14.1 14.42 10.6 12.9 11 10.8 11.54 82.1 10 11.1 8.98 16.4 14.5 Con a ATR 75 ATR 150 p,

p'DDE 50 p,

p'DDE 100 Vin 30 Vin 100 Met 25 Met 50 Con b PTU 2 PTU 25 Keto 50 Keto 100 Linuron 50 Linuron 100 PB 50 PB 100 0 5 10 15 20 TSH ** **

** ** ** ** *

** **

**

Effects of toxicants on Thyroid Hormones in the Male Pubertal Contract Study III 2003 Summary of Contract Studies

All studies found alterations in thyroid parameters that were consistent with the chemical action   Thyroid Weights

Both Contract II and III found appropriate differences in weights, Contract I did not take weights.

  Thyroid Hormones

PTU   Contract I and III identified PTU thyroid hormone effects ( T4 and TSH)

  Contract II did not test PTU

PB   Contract III identified changes in TSH, but no T4 decrease   Contract II did not measure hormones Identifying other chemicals ( ORD studies)

Perchlorate KI symporter

DE 71 Liver metabolism of T4 The Effect of Perchlorate on Thyroid Endpoints in the Male Pubertal 0 1 2 3 4 5 6 Control 62.5 mg/ kg 125 mg/ kg 250 mg/ kg 500 mg/ kg Total Serum T4 (

ug/

dl) Treatments * * * 0 1 2 3 4 Control 62.5 mg/ kg 125 mg/ kg 250 mg/ kg 500 mg/ kg Serum TSH (

ng/

ml) Treatments * * *

EPA Special Study Wistar Rat The Effect of Perchlorate on Thyroid Endpoints in the Female Pubertal Protocol 0 1 2 3 4 5 6 Control 62.5 mg/ kg 125 mg/ kg 250 mg/ kg 500 mg/ kg Total Serum T4 (

ug/

dl) Treatments *

*

* 0 0.5 1 1.5 2 2.5 3 3.5 Control 62.5 mg/ kg 125 mg/ kg 250 mg/ kg 500 mg/ kg Serum TSH (

ng/

ml) Treatments Females *

EPA Special Study Wistar Rat 5 Day 31 Day 0 1 2 3 4 5 6 7 Control 3mg/ kg 30mg/ kg 60mg/ kg Total Serum T4 (

ug/

dl) * * *

*

*

Treatments 5 Day 31 Day 0 0.5 1 1.5 2 2.5 3 Control 3mg/ kg 30mg/ kg 60mg/ kg Serum TSH (

ng/

ml) * *

Treatments The Effect of DE 71 on Thyroid Endpoints in the Male Pubertal Protocol EPA Special Study Wistar Rat 5 Day 20 Day 0 1 2 3 4 5 Control 3 mg/ kg 30 mg/ kg 60 mg/ kg Total Serum T4 (

ug/

dl) Treatments * * * * 5 Day 20 Day 0 0.5 1 1.5 2 Control 3 mg/ kg 30 mg/ kg 60 mg/ kg Serum TSH (

ng/

ml) Treatments The Effect of DE 71 on thyroid endpoints in the Female Pubertal Protocol EPA Special Study Wistar Rat T3 in DE 71 Study Comparison of Male and Female 5 Day 20 Day 0 50 100 150 200 Control 3 mg/ kg 30 mg/ kg 60 mg/ kg Total Serum T3 (

ng/

dl) Treatments 5 Day 31 Day 0 20 40 60 80 100 120 140 Control 3mg/ kg 30mg/ kg 60mg/ kg *

*

Total Serum T3 (

ng/

dl) Treatments EPA Study Wistar Rat Thyroid Histopathology ( hypo)

Decreased Colloid Area

Increased Follicular proliferation and cell heights. Hypothyroidism EPA DE 71 Study Control Male Thyroid 60 mg/ kg DE 71 Male Thyroid Also observed in female 60 mg/ kg DE 71. Conclusions

Male and Female Pubertals.

  No failures so far   3 mechanisms examined   Do we need to do other mechanisms, before moving on? 5' Deiodinase inhibitor, TTR, hypothalamus??

  Some disappointments ( maybe)

One contract lab missed PB effect on T4   Still thyroid effects observed! ( TSH, liver, thyroid wt.) 0 2 4 6 8 10 12 14 Control 50 PB 100PB Liver Wt.(

g) * * 0 10 20 30 40 50 60 70 Control 50PB 100PB 240PTU Thyroid Wt.

(

mg)

0 5 10 15 20 25 Control 50PB 100PB 240PTU TSH (

ng/

ml) *

* 0 1 2 3 4 5 6 7 8 Control 50PB 100PB 240PTU T4 (

ug/

dl) *

*

*

Marty et al.,

Tox. Sci., 2001) Control PB5 PB25 PB50 PB100 0 1 2 3 4 5 6 SE Control * * *

Liver (%

BW) Control PTU. 025 PTU. 25 PTU1 PTU10 0 1 2 3 4 5 SE Mean Liver (%

BW)

O'Connor, 1999 15 Day SD Male The Effect of PB and PTU on Liver in the Intact 15 Day Male Assay Control PB5 PB25 PB50 PB100 0 1 2 3 4 5 SE Mean * * *

T4 (

ug/

dl) Control PB5 PB25 PB50 PB100 0 5 10 15 20 25 30 35 SE Mean TSH (

ng/

ml) * *

O'Connor, 1999 The Effect of PB on Thyroid Hormones in the 15 Day Intact Male SD Control PTU. 025 PTU. 25 PTU1 PTU10 0 10 20 30 40 50 60 SE Mean * * *

O'Connor 15 day male SD TSH (

ng/

ml)

Control PTU. 025 PTU. 25 PTU1 PTU10 0 0.5 1 1.5 2 2.5 3 3.5 SE Mean * * *

T4 (

ug/

dl) O'Connor Studies

Contract studies   Therimmune 2000

PTU ( 240) , male and female in SD and LE   Therimmune 2003

PB ( 25, 50, 100 mg/ kg) male and female SD   RTI

PTU ( 2 and 25 mg/ kg) male and female SD

PB ( 50 and 100 mg/ kg) male and female SD

EPA studies   PBDE and perchlorate.

Industry studies   Marty et al., PB 50 and 100 mg/ kg and PTU 240 mg/ kg in male SD   O'Connor et al., PB 5, 25, and 50 mg/ kg or PTU .025, .25, 1 and 10 mg/ kg in SD males ( 15 day intact)

  Yamada, PB at 125 mg/ kg and PTU at 2.5 mg/ kg ( 10 day HERSH) 0 5 10 15 20 25 Control PB50 PB100 PTU2 PTU25 Males Liver wt.

(

g) * * * *

0 2 4 6 8 10 12 Control PTU2 PTU25 Female Liver wt (

g) *

Contract Study III 2003 The effect of chemicals on liver weight in the Male and Female Pubertal Effect of chemicals on liver weight in Male and Female Pubertals Control PB25 PB50 PB100 0 5 10 15 Liver wt (

g)

Contract Study II 2003 Control PB25 PB50 PB100 0 5 10 15 20 25 Female Male *

*

*

*


2011Addendum: An Assessment of

Environmental Problems Associated with Recycling of

Hazardous Secondary Materials

June 30, 2011

U.S. Environmental Protection Agency

Office of Resource Conservation and Recovery

DISCLAIMER

Mention of trade names, products or services in this document does not
convey, and should not be interpreted to convey, official EPA approval,
endorsement, or recommendation, or lack thereof.

ACKNOWLEDGEMENTS

This addendum was funded and managed by the U.S. Environmental
Protection Agency. Data collection and presentation were conducted by
ICF International under contract to the Environmental Protection Agency.

Staff members of the Recycling and Generator Branch, Office of Resource
Conservation and Recovery, EPA Headquarters were responsible for
providing objectives of the addendum, reviewing the methodology, helping
to identify cases for further investigation, reviewing draft write-ups
and drafting portions of the study. The EPA Work Assignment Manager was
Amanda Geldard.

EPA was responsible for identifying potential cases, including those
submitted through public comment as part of the Definition of Solid
Waste Rulemaking process. Staff of ICF International were responsible
for investigating potential cases, assembling relevant information,
contacting persons with knowledge of selected cases, and drafting
descriptions of each case.

2011 Addendum: An Assessment of Environmental Problems Associated with

Recycling of Hazardous Secondary Materials

I. Introduction

In January 2007, U.S. Environmental Protection Agency (EPA) published
HYPERLINK "http://www.regulations.gov/" \l
"!documentDetail;D=EPA-HQ-RCRA-2002-0031-0355"  An Assessment of
Environmental Problems Associated with Recycling of Hazardous Secondary
Materials  (also know as the “environmental problems study” or
“study”).  This study was conducted as part of EPA’s effort to
revise the current “definition of solid waste” under the Resource
Conservation and Recovery Act (RCRA), as it pertains to recycling of
hazardous wastes and other hazardous secondary materials. In particular,
the information in this study was compiled to assist the Agency in
making decisions as to the scope and substance of these regulatory
revisions. Since the study was published in 2007, EPA has continued to
assess new reports of environmental problems associated with the
recycling of hazardous secondary materials. A first   HYPERLINK
"http://www.regulations.gov/" \l
"!documentDetail;D=EPA-HQ-RCRA-2002-0031-0601"  addendum to the study
was published in July 2008. This 2011 Addendum is EPA’s second update
to the study.

II. Scope of the Study

The general goal of the study is to identify and characterize cases of
environmental damage that have been attributed to some type of hazardous
material recycling activity, and that are relevant for the purpose of
evaluating the impacts of the DSW rulemaking effort. In this 2011
Addendum, EPA evaluated nine potential damage cases that were identified
after the 2008 DSW final rule was published.

III. Methodology

The nine potential damage cases were collected from news media and from
recent enforcement cases that were forwarded to us by state and EPA
regional staff. For this addendum, we did not conduct a general search
for additional damage cases and instead only evaluated those that have
been brought to our attention since we published the last addendum to
the study in 2008.

EPA used the same methodology to evaluate the nine potential damage
cases as we used for the 2007 environmental problems study and its 2008
addendum. Detailed information regarding EPA’s methodology can be
found in the   HYPERLINK "http://www.regulations.gov/" \l
"!documentDetail;D=EPA-HQ-RCRA-2002-0031-0355"  2007 Environmental
Problems Study .

IV. Summary

Of the nine potential damage cases considered, five are determined to be
new recycling damage cases fit to be included in this second addendum to
the study. Additionally, one potential damage case was already included
in the 2007 study and we are providing an update to this damage case in
this Addendum.

This Addendum includes the following Appendices:

Appendix I: Additional Damage Cases from Recycling of Hazardous
Secondary Materials This 2011 Addendum adds five new damage case sites
and one update to a damage case included in the 2007 study. These damage
cases were found to meet the scope of the original environmental
problems study. A summary of the additional damage cases and individual
profiles are located in the Addendum’s Appendix I.

Appendix II: Additional Sites Considered But Not Included in the Damage
Case Analysis

In preparing the 2011 Addendum, EPA identified and reviewed three
additional, potential damage cases, but decided they would not be
included in the environmental problems study because the damage in each
case was determined to be unrelated to recycling of hazardous secondary
materials. The Addendum’s Appendix II contains a summary of sites
considered but not included in the study.

Appendix III: Analysis of Recycling Damage Case Facilities that Are Also
Intermediate Facilities The analysis identified a total of two
intermediate facilities out of seven included in the 2011 addendum.
Although these facilities are intermediate facilities, both also manage
some waste on site. EPA used the same methodology for determining
intermediate facilities as we did in the   HYPERLINK
"http://www.regulations.gov/" \l
"!documentDetail;D=EPA-HQ-RCRA-2002-0031-0601"  2008 addendum . The 2011
Addendum’s Appendix III includes a table of these intermediate
facilities.

 PAGE

 PAGE   - 1 -


[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60280-60281]
[FR Doc No: 2020-21036]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on a Land Release Request at Malden
Regional Airport & Industrial Park (MAW), Malden, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release of airport land.

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

SUMMARY: The FAA proposes to rule and invites public comment on the
request to release and sell a 0.73 acre parcel and a 12.72 acre parcel
of federally obligated airport property at the Malden Regional Airport
& Industrial Park (MAW), Malden, Missouri.

DATES: Comments must be received on or before October 26, 2020.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Amy J. Walter, Airports Land
Specialist, Federal Aviation Administration, Airports Division, ACE-
620G, 901 Locust, Room 364, Kansas City, MO 64106.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to: David Blalock, Airport Manager, City of Malden
Regional Airport & Industrial Park, 3077 Mitchell Drive, P.O. Box 411,
Malden, MO 63863-0411,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amy J. Walter, Airports Land
Specialist, Federal Aviation Administration, Airports Division, ACE-
620G, 901 Locust, Room 364, Kansas City, MO 64106,<PHONE_NUMBER>,
<EMAIL_ADDRESS>The request to release property may be reviewed, by
appointment, in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release a 0.73 acre parcel and a 12.72 acre parcel of
airport property at the Malden Regional Airport & Industrial Park (MAW)
under the provisions of 49 U.S.C. 47107(h)(2). This is a Surplus
Property Airport. The City of Malden requested a release from the FAA
to sell the two parcels to Aycorp, LLC which proposes residential
duplex

development of the 0.73 acre parcel and industrial development of the
12.72 acre parcel. The FAA determined this request to release and sell
property at the Malden Regional Airport & Industrial Park (MAW)
submitted by the Sponsor meets the procedural requirements of the FAA
and the release and sale of the property does not and will not impact
future aviation needs at the airport. The FAA may approve the request,
in whole or in part, no sooner than thirty days after the publication
of this notice.
    The following is a brief overview of the request:
    The Malden Regional Airport & Industrial Park (MAW) is proposing
the release and sale of two parcels of airport property containing 0.73
acres and 12.72 acres. The release of land is necessary to comply with
Federal Aviation Administration Grant Assurances that do not allow
federally acquired airport property to be used for non-aviation
purposes. The sale of the subject property will result in the land at
the Malden Regional Airport & Industrial Park (M) being changed from
aeronautical to non-aeronautical use and release the lands from the
conditions of the Airport Improvement Program Grant Agreement Grant
Assurances in order to sell the land. In accordance with 49 U.S.C.
47107(c)(2)(B)(i) and (iii), the airport will receive fair market value
for the property, which will be subsequently reinvested in another
eligible airport improvement project for general aviation use.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT. In
addition, any person may request an appointment to inspect the
application, notice and other documents determined by the FAA to be
related to the application in person at the Malden City Hall.
    Issued in Kansas City, MO, on September 16, 2020.

Jim A. Johnson,
Director, FAA Central Region, Airports Division.
[FR Doc. 2020-21036 Filed 9-23-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Rules and Regulations]
[Pages 45199-45200]
[FR Doc No: 2011-18992]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0571; FRL-9444-7]

Interim Final Determination To Defer Sanctions, San Joaquin
Valley Unified Air Pollution Control District, CA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule.

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

SUMMARY: EPA is making an interim final determination to defer
imposition of sanctions based on a proposed determination, published
elsewhere in this Federal Register, that the State of California has
submitted a rule that satisfies the requirements of Clean Air Act (CAA)
Section 185 fee program.

DATES: This interim final determination is effective on July 28, 2011.
However, comments will be accepted until August 29, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0571, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. 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.
    Docket: Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Lily Wong, EPA Region IX, (415) 947-
4114<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

I. Background

    On January 13, 2010 (75 FR 1716), EPA published a final limited
approval and limited disapproval of revisions to the San Joaquin Valley
Unified Air Pollution Control District (SJVUAPCD) portion of the
California State Implementation Plan (SIP). EPA's final action
concerned SJVUAPCD Rule 3170, ``Federally Mandated Ozone Nonattainment
Fee,'' a fee rule which applied to major sources of volatile organic
compounds (VOCs) and oxides of nitrogen (NOX) emissions.
SJVUAPCD submitted Rule 3170 pursuant to section 185 of the CAA. EPA
determined that while Rule 3170 strengthened the SIP, it did not fully
meet the requirements of section 185 of the CAA. EPA's final action
started a sanctions clock for imposition of offset sanctions 18 months
after February 12, 2010 and highway sanctions 6 months after offset
sanctions, pursuant to section 179 of the CAA and our regulations at 40
CFR 52.31.
    On May 19, 2011, SJVUAPCD amended Rule 3170 and on June 14, 2011,
the California Air Resources Board (CARB) submitted amended Rule 3170.
In the Proposed Rules section of today's Federal Register, we have
proposed approval of this submittal. Based on today's proposed
approval, we are taking this final rulemaking action, effective on
publication, to defer imposition of sanctions that were triggered by
our January 13, 2010 limited approval and limited disapproval of Rule
3170, based on a finding that it is more likely than not that the
SJVUAPCD has submitted a rule that meets the requirements of sections
172(e) and 185 of the CAA.
    EPA is providing the public with an opportunity to comment on this
deferral of sanctions. If comments are submitted that change our
assessment described in this final determination and the proposed
approval of Rule 3170, we would take final action proposing to
partially or fully disapprove Rule 3170 and lifting this deferral of
the sanctions. If no comments are submitted that change our assessment,
then with regard to the failure to meet the requirements of section 185
of the CAA, any imposed sanctions would no longer apply and any
sanction clocks would be permanently terminated on the effective date
of a final approval of Rule 3170.

II. EPA Action

    We are making an interim final determination to defer CAA section
179 sanctions associated with SJVUAPCD's 1-hour Ozone CAA section 185
obligation based on our concurrent proposal to fully approve Rule 3170
as meeting sections 172(e) and 185 of the CAA.
    Because EPA has preliminarily determined that Rule 3170 meets the
requirements of sections 172(e) and 185 of the CAA and is fully
approvable, relief from sanctions should be provided as quickly as
possible. Therefore, EPA is invoking the good cause exception under the
Administrative Procedure Act (APA) in not providing an opportunity for
comment before this action takes effect (5 U.S.C. 553(b)(3)). However,
by this action EPA is providing the public with a chance to comment on
EPA's determination after the effective date, and EPA will consider any
comments received in determining whether to reverse such action.
    EPA believes that notice-and-comment rulemaking before the
effective date of this action is impracticable and contrary to the
public interest. EPA has reviewed the State's submittal and, through
its proposed action, is indicating that it is more likely than not that
the State has submitted a revision to the SIP that meets sections
172(e) and 185 of the CAA that was the basis for the action that
started the sanctions clocks. Therefore, it is not in the public
interest to impose sanctions. EPA believes that it is necessary to use
the interim final rulemaking process to defer sanctions while EPA
completes its rulemaking process on the approvability of the State's
submittal. Moreover, with

respect to the effective date of this action, EPA is invoking the good
cause exception to the 30-day notice requirement of the APA because the
purpose of this notice is to relieve a restriction (5 U.S.C. Sec.
553(d)(1)).

III. Statutory and Executive Order Reviews

    This action defers Federal sanctions and imposes no additional
requirements.
    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.
    This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action.
    The administrator certifies that this action 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 (Public Law 104-4).
    This rule does not have tribal implications because it will not
have a substantial direct effect on one or more Indian tribes, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
    This action 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 rule 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.
    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply to
this rule because it imposes no standards.
    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 to Congress and the Comptroller
General. However, section 808 provides that any rule for which the
issuing agency for good cause finds that notice and public procedure
thereon are impracticable, unnecessary, or contrary to the public
interest, shall take effect at such time as the agency promulgating the
rule determines. 5 U.S.C. 808(2). EPA has made such a good cause
finding, including the reasons therefore, and established an effective
date of July 28, 2011. 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 rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 26, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purpose of judicial review nor does
it extend the time within which petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

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

    Dated: July 19, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-18992 Filed 7-27-11; 8:45 am]
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