[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Proposed Rules]
[Pages 5347-5350]
[FR Doc No: 2013-01415]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 85, 86, 600

[EPA-HQ-OAR-2009-0472; FRL-9772-7]

Denial of Reconsideration Petition on Model Year 2012-2016 Light
Duty Vehicle Greenhouse Gas Emissions Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Denial of petition for reconsideration.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
providing notice that it is denying the petition of the Pacific Legal
Foundation (PLF) to reconsider the final rules establishing greenhouse
gas emissions standards from light duty motor vehicles for model years
2012-2016.

DATES: This action is effective on January 25, 2013.

ADDRESSES: EPA's docket for this action is Docket ID No. EPA-HQ-OAR-
2009-0472. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
EPA's Docket Center, Public Reading Room, EPA West Building, Room 3334,
1301 Constitution Avenue NW., Washington, DC 20004. This Docket
Facility 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 Air Docket is
(202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Steven Silverman, Office of General
Counsel, Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Acronyms and Abbreviations. The following acronyms and
abbreviations are used in this Decision.

APA Administrative Procedures Act
API American Petroleum Institute
CAA Clean Air Act
CO2 Carbon dioxide
CH4 Methane
EPA Environmental Protection Agency
FOIA Freedom of Information Act
FR Federal Register
GHG Greenhouse gas
HFC Hydrofluorocarbon
LDVR Light Duty Vehicle Rule
MY Model year
N2O Nitrous oxide
NHTSA National Highway Traffic Safety Administration
PLF Pacific Legal Foundation
SAB Science Advisory Board

I. Introduction

    On May 7, 2010, the EPA published final rules establishing
standards limiting emissions of carbon dioxide (CO2),
methane (CH4), nitrous oxide (N2O) and
hydrofluorocarbons (HFCs) from new light duty motor vehicles, including
passenger cars, medium duty passenger vehicles, and light trucks for
model years 2012-2016. 75 FR 25324. In this joint rulemaking, the
National Highway Traffic Safety Administration (NHTSA), on behalf of
the Department of Transportation, issued rules to reduce fuel
consumption from these vehicles. Together these rules comprise a
coordinated and comprehensive National Program designed to address the
urgent and closely intertwined challenges of reducing dependence on
oil, achieving energy security, and ameliorating global climate change.
PLF petitioned EPA to reconsider its greenhouse gas standards. Because
the petition does not state grounds which satisfy the requirements of
section 307(d)(7)(B) of the Clean Air Act, EPA is denying the petition.

II. Standard for Reconsideration

    Section 307(d)(7)(B) of the Clean Air Act (CAA) states that: ``Only
an objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review. If the person raising an
objection can demonstrate to the Administrator that it was
impracticable to raise such objection within such time or if the
grounds for such objection arose after the period for public comment
(but within the time specified for judicial review) and if such
objection is of central relevance to the outcome of the rule, the
Administrator shall convene a proceeding for reconsideration of the
rule and provide the same procedural rights as would have been afforded
had the information been available at the time the rule was proposed.
If the Administrator refuses to convene such a proceeding, such person
may seek review of such refusal in the United States court of appeals
for the

appropriate circuit. Such reconsideration shall not postpone the
effectiveness of the rule. The effectiveness of the rule may be stayed
pending such reconsideration, however, by the Administrator or the
court for a period not to exceed three months.''
    Thus, reconsideration is required only if a petition for
reconsideration shows that the objection or claim could not have been
presented during the comment period--either because it was
impracticable to raise the objection during that time or because the
grounds for raising the objection arose after the period for public
comment but within 60 days of publication of the final action (i.e.
``the time specified for judicial review''). To be of central relevance
to the outcome of a rule, an objection must provide substantial support
for the argument that the promulgated regulation should be revised. See
Coalition for Responsible Regulation v. EPA, 684 F.3d 102, 125 (D.C.
Cir. 2012); see also 76 FR 28318 (May 17, 2011) and other actions there
cited.
    Because all of the objections or claims raised in PLF's petition
could have been presented to EPA during the comment period for the
rulemaking, and because PLF has failed to demonstrate that its
objection is of central relevance to the outcome of the rulemaking, EPA
is denying the request for reconsideration.

III. PLF's Petition for Reconsideration

    In its petition, PLF alleges that EPA failed to comply with the
requirements of 42 U.S.C. section 4365(c)(1). This provision states
that ``[t]he Administrator, at the time any proposed criteria document,
standard, limitation or regulation under the Clean Air Act, the Federal
Water Pollution Control Act, the Resource Conservation Recovery Act,
the Noise Control Act, the Toxic Substances Control Act, or the Safe
Drinking Water Act, or under any other authority of the Administrator,
is provided to any other Federal agency for formal review and comment,
shall make available to the [Science Advisory Board, or SAB] such
proposed criteria document, standard, limitation, or regulation,
together with relevant scientific and technical information in the
possession of the Environmental Protection Agency on which the proposed
action is based.'' Section 4365(c)(2) then provides that ``[t]he Board
may make available to the Administrator, within the time specified by
the Administrator, its advice and comments on the adequacy of the
scientific and technical basis of the proposed criteria document,
standard, limitation, or regulation, together with any pertinent
information in the Board's possession.''
    PLF maintains that EPA failed to make the proposed model years
(MYs) 2012-2016 light duty vehicle greenhouse gas (GHG) rule available
to the SAB. PLF then argues that this alleged failure is of central
relevance to the outcome of the rulemaking, arguing that an ``utter
failure'' of EPA to comply with a procedural requirement imposed by a
statute other than the Clean Air Act is of central relevance if there
is any uncertainty as to the impact of the failure (Petition pp. 7, 17-
18), or in the alternative that there is a substantial likelihood that
the rule would have significantly changed absent the alleged procedural
error by EPA (Id. pp. 8, 18-21). PLF maintains that there is a
substantial likelihood that the rule would have changed by assuming
that the SAB would have provided scientific and technical advice to EPA
of sufficient import to change the rule's outcome, consistent with the
SAB's august scientific standing and the Congressional purpose in
establishing the opportunity for SAB review. Id. PLF further maintains
that it could not raise its objection to EPA until after the close of
the public comment period to the rulemaking, stating that it did not
become aware of the issue until November 10, 2010, when EPA replied to
PLF's Freedom of Information Act request seeking copies of ``[a]ll
documents, memorandums (sic) or correspondences (sic) dealing with the
question of whether EPA should submit, or should have submitted,
information to the Science Advisory Board in connection with the
promulgation of the [light duty vehicle rule] LDVR''. PLF FOIA Request
of September 15, 2010 p. 1.

IV. EPA's Response

    1. PLF has failed to demonstrate that ``it was impracticable to
raise [its] objection'' during the period for public comment in the
rulemaking, or in the time specified for seeking judicial review (i.e.
within 60 days of the rule's publication--July 10, 2010), as required
by CAA section 307(d)(7)(B).
    PLF's objection is legal in nature, and thus could be raised at any
time. PLF maintains that it could not raise its objection until
receiving a response to its Freedom of Information Act request, but
this is not correct. PLF's public comments could simply have stated
PLF's belief that 42 U.S.C. section 4365(c) requires EPA to submit the
proposed rule to the SAB, and that any failure to do so is error. PLF
states that it required an answer to its FOIA request before raising
its objection because only then did it learn that EPA had not submitted
the light duty vehicle proposal to the SAB. Petition p. 13. But its
objection does not require this answer. Moreover, PLF did not submit
its FOIA request until September 15, 2010, well after the rule was
signed, disseminated electronically, and published, and after the
period for seeking judicial review of the rule had expired. Thus, even
under its view, the grounds for PLF's objection did not arise until
after the time period for judicial review so that PLF's objection was
raised in an untimely manner regardless of its argument concerning its
FOIA petition. In addition, EPA's FOIA response does not provide PLF
with information necessary to raise its objection, since the FOIA
request asked whether EPA ``submitted'' the proposed rule and related
documents to the SAB. The statutory requirement in section 4365(c) is
for EPA to ``make available'' certain proposals to the SAB, as
discussed below. Thus, PLF was in essentially the same position after
receiving EPA's FOIA response as it was before its request. The same
objection it raised in the petition could have been raised during the
public comment period.
    2. PLF fails to demonstrate that its objection is of central
relevance to the outcome of the rulemaking, as required by section
307(d)(7)(B).
    First, PLF fails to demonstrate that 42 U.S.C. 4365(c)(1) is
applicable. That provision applies only when EPA submits certain
documents to other agencies ``for formal review and comment.'' The
light duty vehicle GHG rule implements section 202(a) of the Clean Air
Act. That provision contains no requirement that implementing
regulations be submitted to other federal agencies for formal review
and comment, nor did EPA do so. EPA submitted the draft of the proposed
rule to the Office of Management and Budget for informal interagency
review, pursuant to Executive Order 12866, but this is not the type of
formal review to which section 4365(c)(1) speaks. See Coalition for
Responsible Regulation v. EPA, 684 F. 3d at 124 (noting this
distinction); compare CAA section 202(a) with 49 U.S.C. section
32902(b) and (j) requiring the Secretary of Transportation to consult
with the Secretary of Energy and the Administrator of EPA before
prescribing average fuel economy standards for light duty motor
vehicles, and requiring the Secretary of Transportation to provide a
period of time for the Secretary of Energy to submit comments and for
those comments to be included in any proposal issued by the Secretary
of

Transportation; see also CAA section 231(a)(1)(B)(i) (``The
Administrator shall consult with the Administrator of the Federal
Aviation Administration on aircraft engine emission standards'').
    Second, even assuming that the provision applies, EPA did make the
proposed regulation and supporting information available to the SAB in
advance of the public comment period. Documents are made available when
they are ``accessible'' or ``obtainable.'' Collins English Dictionary--
Complete and Unabridged (Harper Collins 2003) (definition of
``available''). EPA made the proposed rule and underlying support
documents accessible and obtainable by publication of the proposed rule
in the Federal Register, and via mass electronic dissemination by
posting both the proposed rule and all of the scientific and technical
support documents on the Agency's Web site essentially
contemporaneously with their signature by the Administrator.\1\
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    \1\ EPA is aware that the D.C. Circuit, in holding that EPA had
not made available a proposed regulation to the SAB, stated that EPA
had not ``submitted'' the proposed regulation to the Board. American
Petroleum Inst. v. EPA, 665 F.2d 1176, 1189 (D.C. Cir. 1981). This
case, however, antedated the present period of instantaneous
availability of documents via electronic dissemination. EPA believes
that by publishing and posting the proposed regulation and the
scientific and technical support documents those materials have been
made available to the SAB.
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    Third, even assuming arguendo that EPA committed a procedural
error, PLF has failed to demonstrate that its objection provides
substantial support for the argument that the promulgated regulation
should be revised, and therefore is of central relevance to the outcome
of the rule. CAA section 307(d)(7)(B).
    PLF argues that there is a substantial likelihood that the rule
would have changed if EPA had followed the claimed procedure, by
assuming that the SAB would have provided scientific and technical
advice to EPA of sufficient import to change the rule's outcome,
consistent with the SAB's scientific standing and the Congressional
purpose in establishing the opportunity for SAB review. Petition pp. 8,
21. This is unpersuasive. The SAB explicitly declined to consider and
``make available * * * advice and comments on the adequacy of the
scientific and technical basis'' on the proposed light duty vehicle GHG
standards for model years 2017 to 2025 in response to EPA's
communication to SAB about the proposal and supporting documents.\2\
That proposal built upon and was closely related to the rulemaking that
established the standards for MYs 2012-2016, the subject of PLF's
petition here. Moreover, as in the MYs 2017-2025 rulemaking,
substantial issues of pure science were not presented in the MYs 2012-
2016 rulemaking. Instead the critical issues were what technologies are
available for light-duty vehicles to reduce greenhouse gases for MYs
2012-2016, the cost and effectiveness of those technologies, and their
availability in the lead time provided by the rule, making SAB
participation both less likely and less pertinent. See 75 FR at 25403-
04. Indeed, none of the public comments in the MY2012-2016 rulemaking
took serious issue that EPA had overestimated potential technology
availability, penetration and cost. \3\ See EPA, Light Duty Vehicle
Emission Standards and Corporate Average Fuel Economy Standards: EPA
Response to Comment Document (EPA-420-R-10-012, April 2010), section 3.
There were no judicial challenges to the rule's substantive standards
at all. See Coalition for Responsible Regulation, 684 F.3d at 126.
Given these circumstances, EPA does not see any significant likelihood
that SAB involvement would have occurred or would have changed
significantly the technology-based standards adopted in the rule. The
petitioner has therefore failed to carry its burden of showing that its
objection provides substantial support for the argument that the
promulgated regulation should be revised and therefore is of central
relevance to the rule. CAA section 307(d)(7)(B).
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    \2\ PLF did not present either oral or written statements to the
SAB at its public meeting, even though the meeting was publically
noticed, comments were solicited by the SAB, and other entities
submitted an oral and written statement to the SAB (addressing a
different proposed rule). See 77 FR 12579, 12580 (March 1, 2012) and
EPA-HQ-OAR-2010-0799-11793.
    \3\ PLF indicates that its interest in the rulemaking is that
its members are light duty vehicle users and may incur greater costs
as a result of the light duty vehicle rule's stringency, Petition
pp. 2-3, although it submitted no comments on these issues.
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    Notwithstanding the clear requirement in section 307(d)(7)(B) that
its objection must be of central relevance to the outcome of the rule,
PLF argues that it does not have to make a showing to that effect. PLF
argues instead that the test under section 307(d)(7)(B) varies
depending on whether the procedural requirement at issue derives from
the CAA or from another statutory provision. While PLF's argument is
not exactly clear, PLF argues that for procedural requirements imposed
by a statute other than the CAA, an ``utter failure'' to comply with a
required procedure is not harmless error under section 307(d)(7)(B) if
there is any uncertainty of the impact of the error. For procedural
requirements imposed by the CAA, PLF argues that the explicit test of
section 307(d)(8) applies, ``substantial likelihood that the rule would
have been significantly changed if such errors had not been made.'' PLF
argues that this case falls under the first asserted principle, as the
procedural requirement derives from a statute other than the CAA. PLF
thus argues there was an utter failure to comply with 42 U.S.C. section
4365(c), and there is some uncertainty of the impact of the failure. In
the alternative, they argue that even if the second test applies, this
case meets the criteria of section 307(d)(8), citing to Kennecott Corp.
v. EPA, 684 F.2d 1007 (D.C. Cir. 1982)
    EPA disagrees that this bifurcated scheme is the appropriate test
to apply. Section 307(d)(7)(B) is the applicable provision here, and
its test is whether PLF's objection provides substantial support for
the argument that the promulgated regulation should be revised. There
is no basis in the text of section 307(d)(7)(B) to draw a distinction
based on whether a procedural requirement is imposed by the Clean Act
or by another statute. Section 307(d)(7)(B) establishes the same
requirements irrespective of the statutory source of the procedural
requirement a petitioner points to. Section 307(d)(7)(B), like section
307(d)(8), embodies a significant hurdle for administrative
reconsideration, and reflects the value placed on preserving the
finality of EPA decision making. 75 FR 49556, 49560-62 (August 13,
2010). This is so whether the procedural requirement derives from the
CAA or from another statute.
    The cases cited by PLF do not support their view of a bifurcated
scheme under section 307(d)(7)(B). PLF argues that ``[w]hen an
administrative agency utterly fails to comply with a procedural
rulemaking requirement imposed by a statute other than the one under
which the rule is being promulgated, the failure cannot be considered
harmless error if there is any uncertainty regarding what the rule may
have been but for the failure.'' Petition p. 7. PLF cites New Jersey v.
EPA, 626 F. 2d 1038, 1049-50 (D.C. Cir. 1980) and Sugar Cane Growers
Coop. of Fla. v. Veneman, 289 F. 3d 89, 96 (D.C. Cir. 2002) for this
proposition. However these cases do not pronounce the general rule
petitioners claim, and are not on point. Both State of New Jersey and
Sugar Cane Growers concerned rules that were not subject to section
307(d) at all, so the cases do not address and are not relevant to the

requirement imposed by section 307(d)(7)(B). Rather, both cases dealt
with a failure of the government agency to follow the notice and
comment procedures required for rulemaking under the Administrative
Procedure Act (APA). The views of the court on the lack of harmless
error under those specific circumstances addressed that violation of
the APA, and did not provide a more general rule applicable to any and
all other procedural violations or other statutes. Here, EPA fully
complied with the rulemaking procedures required under CAA section
307(d). There was no ``utter failure'' to conduct notice and comment
rulemaking procedures.
    As discussed above, EPA was not required to but did make the
proposed rule available to the SAB pursuant to 42 U.S.C. section
4365(c)(1). Under that statute there is no requirement or expectation
that the SAB will in fact voluntarily provide advice and comments to
EPA and in this case, as discussed above, subsequent SAB action
concerning the MY2017-2025 rulemaking proposal to control greenhouse
gases indicates just the opposite. The New Jersey and Sugar Cane cases
thus addressed wholly different circumstances, and provide no basis to
find that the requirement of CAA section 307(d)(7)(B) does not apply to
this rulemaking according to its terms or that the test it sets for
reconsideration has been met.
    Moreover, the D.C. Circuit recently held with respect to 42 USC
section 4365(c)(1) itself that a petitioner ``must sho[w] that this
error was `of such central relevance to the rule that there is a
substantial likelihood that the rule would have been significantly
changed if such errors had not been made.' '' This was not satisfied
when petitioners provided no more of a showing than alleging that EPA
had failed to comply with this provision. Coalition for Responsible
Regulation v. EPA, 684 F.3d at 124. The Court applied the test in
section 307(d)(8) without drawing any distinction based on the statute
that was the source of the procedural requirement. The same applies
under section 307(d)(7)(B), and as with section 307(d)(8), more must be
shown than simply alleging that EPA failed to comply.
    The petitioner's citation of Small Refiners Lead Phase-Down Task
Force v. EPA, 705 F.2d 506, 522-23 (D.C. Cir. 1983) also does not
support its argument. The petition argues that the 1977 amendments to
the Clean Air Act were intended to supplement the procedural
requirements of the Administrative Procedure Act, not replace them.
Petition p. 9. Construing section 307(d)(8)'s requirement that a
procedural error creates a ``substantial likelihood that the rule would
have been significantly changed'', the court stated that ``[a]t a
minimum, failure to observe the basic APA procedures, if reversible
error under the APA, is reversible error under the Clean Air Act as
well.'' The court immediately cautioned, however, ``[o]n the other
hand, section 307(d)(8) sets a restrictive tone for our review of
procedural errors that would not violate the APA'', citing Sierra Club
v. Costle (657 F.2d at 391) for the proposition that ``the essential
message of so rigorous a standard for procedural reversal is that
Congress was concerned that EPA's rulemaking not be casually overturned
for procedural reasons.'' 705 F.2d at 523. Since the APA itself
contains a harmless error provision (5 USC section 706), requiring
petitioners to show a likelihood that the rule would have changed is
not a diminution of the APA but a gloss on it. Thus, the holding in
Small Refiners was limited to violations of the notice and comment
requirements of the APA, and, contrary to PLF's claim, the court did
not pronounce a general rule establishing a different test for any and
all procedural requirements imposed by other statutes. Rather, in
discussing procedural requirements other than the APA, the court
indicated that section 307(d)(8) applied and set a restrictive tone for
judicial review of such errors.
    More basically, the D.C. Circuit has twice held that failure to
comply with the requirements of section 4365(c)(1) is not reversible
error where petitioners fail to show that the error is of such central
relevance to the proceeding that there is a substantial likelihood that
the rule would have significantly changed but for the (claimed)
procedural violation. Coalition for Responsible Regulation v. EPA, 684
F.3d at 124; API v. EPA, 665 F.2d at 1188-89. The fact that the
procedural requirement at issue in those cases stems from a statute
other than the CAA made no difference and did not change the burden on
the petitioner to prevail on their objection. The same applies under
section 307(d)(7)(B).
    Finally, PLF points to Kennecott Corp. v. EPA, 684 F.2d 1007 (D.C.
Cir. 1982) as support for its claim that EPA's alleged failure to
comply with this statutory provision satisfies the requirements of
section 307(d)(8). As noted above, this same claim was recently
rejected in Coalition for Responsible Regulation v. EPA, 684 F.3d at
124. Here, PLF does no more than describe the purpose of this
provision, with no showing of any likelihood of an impact or change on
the rulemaking. As discussed above, all of the indications point the
other way and indicate no such likelihood, even if one assumes a
procedural error was committed.

V. Conclusion

    The objections or claims raised in PLF's petition could have been
presented to EPA during the comment period for the rulemaking, and the
grounds for the objections did not arise after the period for public
comment but within the time specified for judicial review. In addition,
PLF has failed to demonstrate that its objection provides substantial
support for the argument that the promulgated regulation should be
revised and therefore has failed to demonstrate that its objection is
of central relevance to the outcome of the rulemaking. Based on this,
EPA is denying the request for reconsideration.

    Dated: January 14, 2013.
Lisa P. Jackson,
Administrator.
[FR Doc. 2013-01415 Filed 1-24-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 177 (Friday, September 11, 2020)]
[Notices]
[Pages 56231-56264]
[FR Doc No: 2020-20041]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1729]

Authorizations and Revocation of Emergency Use of Drugs During
the COVID-19 Pandemic; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of four Emergency Use Authorizations (EUAs) (the
Authorizations) for drugs for use during the COVID-19 pandemic. FDA
issued four Authorizations under the Federal Food, Drug, and Cosmetic
Act (FD&C Act), as requested by the Department of Health and Human
Services (HHS) Biomedical Advanced Research and Development Authority
(BARDA), Fresenius Medical Care, Gilead Sciences, Inc., and Fresenius
Kabi USA, LLC. The Authorizations contain, among other things,
conditions on the emergency use of the authorized drugs. The
Authorizations follow the February 4, 2020, determination by the
Secretary of HHS that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus is now named SARS-CoV-2, which causes the
illness COVID-19. On the basis of such determination, the Secretary of
HHS declared on March 27, 2020, that circumstances exist justifying the
authorization of emergency use of drugs and biological products during
the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms
of any authorization issued under that section. FDA is also announcing
the subsequent revocation of the Authorization issued to BARDA for oral
formulations of chloroquine phosphate and hydroxychloroquine sulfate.
FDA revoked this authorization on June 15, 2020. The Authorizations,
and the revocation, which include an explanation of the reasons for
issuance or revocation, are reprinted in this document.

DATES: The Authorization for BARDA was effective as of March 28, 2020,
and the revocation of this Authorization is effective as of June 15,
2020; the Authorization for Fresenius Medical Care is effective as of
April 30, 2020; the Authorization for Gilead Sciences, Inc. is
effective as of May 1, 2020; the Authorization for Fresenius Kabi USA,
LLC is effective as of May 8, 2020.

ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives.

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50, United States Code, of attack with
(i) a biological, chemical, radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of

a drug, device, or biological product intended for use when the
Secretary of HHS has declared that circumstances exist justifying the
authorization of emergency use. Products appropriate for emergency use
may include products and uses that are not approved, cleared, or
licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21
U.S.C. 355, 360(k), 360b, and 360e) or section 351 of the PHS Act (42
U.S.C. 262), or conditionally approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after
consultation with the HHS Assistant Secretary for Preparedness and
Response, the Director of the National Institutes of Health, and the
Director of the Centers for Disease Control and Prevention (to the
extent feasible and appropriate given the applicable circumstances),
FDA \2\ concludes: (1) That an agent referred to in a declaration of
emergency or threat can cause a serious or life-threatening disease or
condition; (2) that, based on the totality of scientific evidence
available to FDA, including data from adequate and well-controlled
clinical trials, if available, it is reasonable to believe that: (A)
The product may be effective in diagnosing, treating, or preventing (i)
such disease or condition; or (ii) a serious or life-threatening
disease or condition caused by a product authorized under section 564,
approved or cleared under the FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating, or preventing such a disease
or condition caused by such an agent; and (B) the known and potential
benefits of the product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks of the
product, taking into consideration the material threat posed by the
agent or agents identified in a declaration under section 564(b)(1)(D)
of the FD&C Act, if applicable; (3) that there is no adequate,
approved, and available alternative to the product for diagnosing,
preventing, or treating such disease or condition; (4) in the case of a
determination described in section 564(b)(1)(B)(ii), that the request
for emergency use is made by the Secretary of Defense; and (5) that
such other criteria as may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. The Authorizations

    The Authorizations follow the February 4, 2020, determination by
the Secretary of HHS that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus is now named SARS-CoV-2, which causes the
illness COVID-19. Notice of the Secretary's determination was provided
in the Federal Register on February 7, 2020 (85 FR 7316). On the basis
of such determination, the Secretary of HHS declared on March 27, 2020,
that circumstances exist justifying the authorization of emergency use
of drugs and biological products during the COVID-19 pandemic, pursuant
to section 564 of the FD&C Act, subject to the terms of any
authorization issued under that section. Notice of the Secretary's
declaration was provided in the Federal Register on April 1, 2020 (85
FR 18250). Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
issued four authorizations for the emergency use of drugs during the
COVID-19 pandemic. On March 28, 2020, FDA issued an EUA to BARDA for
oral formulations of chloroquine phosphate and hydroxychloroquine
sulfate, subject to the terms of the Authorization. On April 30, 2020,
FDA issued an EUA to Fresenius Medical Care for multiFiltrate PRO
System and multiBic/multiPlus Solutions, subject to the terms of the
Authorization. On May 1, 2020, FDA issued an EUA to Gilead Sciences,
Inc. for remdesivir, subject to the terms of the Authorization. On May
8, 2020, FDA issued an EUA to Fresenius Kabi USA, LLC for Fresenius
Propoven 2% Emulsion, subject to the terms of the Authorization. The
Authorizations in their entirety (not including the authorized versions
of the fact sheets and other written materials) follow, below section
VI Electronic Access, and provide an explanation of the reasons for
issuance, as required by section 564(h)(1) of the FD&C Act.

IV. EUA Criteria for Issuance No Longer Met

    Under section 564(g)(2) of the FD&C Act, the Secretary of HHS may
revoke an EUA if, among other things, the criteria for issuance are no
longer met. On June 15, 2020, FDA revoked the EUA for BARDA for oral
formulations of chloroquine phosphate and hydroxychloroquine sulfate
because the criteria for issuance were no longer met. Under section
564(c)(2) of the FD&C Act, an EUA may be issued only if FDA concludes
that, based on the totality of scientific evidence available to the
Secretary, including data from adequate and well-controlled clinical
trials, if available, it is reasonable to believe that: (1) The product
may be effective in diagnosing, treating, or preventing such disease or
condition and (2) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product. Based on a review of new
information and a reevaluation of information available at the time the
EUA was issued, FDA now concludes it is no longer reasonable to believe
that (1) oral formulations of chloroquine phosphate and
hydroxychloroquine sulfate may be effective in treating COVID-19 for
the uses authorized in the EUA, or (2) the known and potential benefits
of these products outweigh their known and potential risks for those
uses. Accordingly, FDA revokes the EUA for emergency use of chloroquine
phosphate and hydroxychloroquine sulfate to treat COVID-19, pursuant to
section 564(g)(2) of the FD&C Act.

V. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for BARDA's oral formulations of chloroquine phosphate
and hydroxychloroquine sulfate. The revocation in its entirety follows,
below section VI. Electronic Access, and provides an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.

VI. Electronic Access

    An electronic version of this document and the full text of the
Authorizations and revocation are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P

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    Dated: September 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20041 Filed 9-10-20; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Proposed Rules]
[Page 70249-70251]
[DOCID:fr11de07-13]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0300; Directorate Identifier 2007-NM-191-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Model F.28 Mark 0070 and 0100
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Reports have been received from Fokker 100 (F28 Mark 0100)
operators where the crew experienced difficulties with roll control.
Analysis suggests that these phenomena are due to frozen water on
the aileron pulleys that are installed on the Center Wing Spar and
located in the Main Landing Gear (MLG) wheel bays. Investigation has
confirmed that improper closure of the aerodynamic seals of the
wing-to-fuselage fairings above the MLG wheel bays can cause
rainwater, wash-water or de-icing fluid to leak onto the affected
aileron pulleys. This condition, if not corrected, can lead to
further incidents of frozen water on aileron pulleys during
operation of the aircraft, resulting in restricted roll control and/
or higher control forces. * * *

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by January 10,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-0300;
Directorate Identifier 2007-NM-191-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Civil Aviation Authority--The Netherlands (CAA-NL), which is
the aviation authority for the Netherlands, has issued Dutch
Airworthiness Directive NL-2005-013, dated October 17, 2005 (referred
to after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Reports have been received from Fokker 100 (F28 Mark 0100)
operators where the crew experienced difficulties with roll control.
Analysis suggests that these phenomena are due to frozen water on
the aileron pulleys that are installed on the Center Wing Spar and
located in the Main Landing Gear (MLG) wheel bays. Investigation has
confirmed that improper closure of the aerodynamic seals of the
wing-to-fuselage fairings above the MLG wheel bays can cause
rainwater, wash-water or de-icing fluid to leak onto the affected
aileron pulleys. [The aileron pulleys on Model F.28 Mark 0070
airplanes are identical to those installed on the Model F.28 Mark
0100 airplanes. Therefore, those Model F.28 Mark 0070 airplanes may
be subject to the unsafe condition revealed on the Model F.28 Mark
0100 airplanes.] This condition, if not corrected, can lead to
further incidents of frozen water on aileron pulleys during
operation of the aircraft, resulting in restricted roll control and/
or higher control forces. Since an unsafe condition has been
identified that is likely to exist or develop on other aircraft of
the same type design, this Airworthiness Directive requires the
inspection of the wing-to-fuselage fairings and, if necessary, the
accomplishment of appropriate corrective action(s).

    The inspection is intended to find indications of incorrect fit,
damage, or wear. Corrective actions include a related investigative
action (inspecting for incorrect fit, damage, or wear of the
aerodynamic seal of the fairings, and inspecting for damage or wear of
the

abrasion resistant coating on the mating surface of the fuselage skin),
restoring damaged abrasion-resistant coatings, correcting fairing
positions, and replacing damaged fairing seals. You may obtain further
information by examining the MCAI in the AD docket.

Relevant Service Information

    Fokker Services B.V. has issued Service Bulletin SBF100-53-101,
dated September 30, 2005. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

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 our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
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.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 12 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $960, or $80 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2007-0300; Directorate
Identifier 2007-NM-191-AD.

Comments Due Date

    (a) We must receive comments by January 10, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Model F.28 Mark 0070 and 0100
airplanes, certificated in any category, all serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Reports have been received from Fokker 100 (F28 Mark 0100)
operators where the crew experienced difficulties with roll control.
Analysis suggests that these phenomena are due to frozen water on
the aileron pulleys that are installed on the Center Wing Spar and
located in the Main Landing Gear (MLG) wheel bays. Investigation has
confirmed that improper closure of the aerodynamic seals of the
wing-to-fuselage fairings above the MLG wheel bays can cause
rainwater, wash-water or de-icing fluid to leak onto the affected
aileron pulleys. [The aileron pulleys on Model F.28 Mark 0070
airplanes are identical to those installed on the Model F.28 Mark
0100 airplanes. Therefore, those Model F.28 Mark 0070 airplanes may
be subject to the unsafe condition revealed on the Model F.28 Mark
0100 airplanes.] This condition, if not corrected, can lead to
further incidents of frozen water on aileron pulleys during
operation of the aircraft, resulting in restricted roll control and/
or higher control forces. Since an unsafe condition has been
identified that is likely to exist or develop on other aircraft of
the same type design, this Airworthiness Directive requires the
inspection of the wing-to-fuselage fairings and, if necessary, the
accomplishment of appropriate corrective action(s).

The inspection is intended to find indications of incorrect fit,
damage, or wear. Corrective actions include a related investigative
action (inspecting for incorrect fit, damage, or wear of the
aerodynamic seal of the fairings, and inspecting for damage or wear
of the abrasion resistant coating on the mating surface of the
fuselage skin), restoring damaged abrasion-resistant coatings,
correcting fairing positions, and replacing damaged fairing seals,
as applicable.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 12 months after the effective date of this AD,
inspect the wing-to-fuselage fairings for indications of incorrect
fit, damage or wear, in accordance with the Accomplishment
Instructions of Fokker Service Bulletin SBF100-53-101, dated
September 30, 2005.

    (i) If no indications of incorrect fit, damage or wear are
found, no further action is required by this AD.
    (ii) If any incorrect fit, damage or wear is found, before next
flight, do related investigative actions and applicable corrective
actions in accordance with the Accomplishment Instructions of the
service bulletin.
    (2) When incorrect fit, damage or wear is found, within 30 days
after the inspection or within 30 days after the effective date of
the AD, whichever occurs later, report the findings to Fokker
Services B.V., Technical Services Dept., P.O. Box 231, 2150 AE
Nieuw-Vennep, The Netherlands.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-1137; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Dutch Airworthiness Directive NL-2005-013,
dated October 17, 2005, and Fokker Service Bulletin SBF100-53-101,
dated September 30, 2005, for related information.

    Issued in Renton, Washington, on November 30, 2007.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
 [FR Doc. E7-23950 Filed 12-10-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Rules and Regulations]
[Pages 48749-48752]
[FR Doc No: 2015-20001]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0793; FRL-9930-20]

Acetic Acid; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues of acetic acid (CAS Reg. No. 64-19-7) when used
as an inert ingredient in antimicrobial pesticide formulations used on
dairy and food-processing equipment and utensils, to allow for a
limitation of 1200 ppm. Technology Sciences Group, Inc. on behalf of
West Agro, Inc. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an amendment to the existing
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of acetic acid.

DATES: This regulation is effective August 14, 2015. Objections and
requests for hearings must be received on or before October 13, 2015,
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-2014-0793, 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>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), 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 Printing 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, 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-2014-0793 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
October 13, 2015. 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-2014-0793, 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. Petition for Exemption

    In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition inert ingredient
(IN-10766) by Technology Sciences Group, Inc. (1150 18th Street, Suite
1000 Washington, DC 20036), on behalf of West Agro, Inc. (11100
Congress Ave., Kansas City, MO 64153). The petition requested that 40
CFR 180.940(b) and (c) be amended by modifying an exemption from the
requirement of a tolerance for residues of acetic acid (CAS Reg No. 64-
19-7) when used as an inert ingredient to promote the active ingredient
in antimicrobial pesticide formulations applied to dairy-processing
equipment, food-processing equipment, and utensils to increase the use
limitation from 686 parts per million (ppm) to 1,200 ppm. That document
referenced a summary of the petition prepared by Technology Sciences
Group, Inc. on behalf of West Agro, Inc., the petitioner, which is
available in the docket, http://www.regulations.gov. No comments were
received on the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance 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. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for acetic acid including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with acetic acid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by acetic acid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    Acetic acid is of low acute dermal and inhalation toxicity in rats.
It causes dermal irritation in mice and is corrosive in rabbits. It was
also irritating in the eyes of rabbits. Although, reduced body weight
was observed at 390 milligrams/kilograms/day (mg/kg/day) in a 90-day
oral toxicity study in the rat, the reduction in weight gain was likely
attributed to reduced appetite and food consumption observed in the
study. Therefore, this is not considered an adverse effect. Fetal
susceptibility was not observed in developmental studies in rats, mice
and rabbits. It is not genotoxic, mutagenic, carcinogenic or
neurotoxic. Although, increased spleen weight and increased levels of
iron stored in the spleen were observed in a toxicity study via
inhalation in rats, these effects are not considered an immunotoxic
response, but are due to the destruction of red blood cells; therefore,
there is no concern for potential immunotoxicity.
    Acetic acid undergoes dissociation to the acetate anion and the H+
cations in aqueous media at pHs commonly found in the environment.
Also, it is a naturally-occurring substance in plants and animals. In
aerobic metabolism, acetic acid (as acetate) is a metabolite that
combines with Co-enzyme A to form acetyl Co-A which subsequently enters
into the Citric Acid Cycle, a

common metabolic pathway in which food molecules are broken down to
form energy. A major function of the Citric Acid Cycle is the oxidation
of acetate. In animals, acetate is obtained from the breakdown of
glucose molecules.
    Specific information on the studies received and the nature of the
adverse effects caused by acetic acid as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Acetic Acid; Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2014-0793.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    Based on the widespread presence of acetic acid in human foods, and
the fact that acetic acid is a normal metabolite in humans and animals
and its status as a substance that is considered Generally Recognized
as Safe (GRAS) by the Food and Drug Administration, toxicological
endpoints of concern relevant to human exposures have not been
identified for acetic acid. Thus, due to its low potential hazard and
lack of hazard endpoint, the Agency has determined that a quantitative
risk assessment using safety factors applied to a point of departure
protective of an identified hazard endpoint is not appropriate.
Instead, the Agency's assessment of the risk from acetic acid is
qualitative.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses and drinking water. In
evaluating dietary exposure to acetic acid, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from acetic acid in food as follows:
    Acetic acid is currently used as a biochemical pesticide post-
harvest on grains, hays for animal feed, and as a herbicide. Under this
exemption from the requirement of a tolerance, residues of this
chemical also may be found on foods that come in contact with treated
dairy and food-processing equipment and utensils. However, a
quantitative dietary exposure assessment was not conducted since an
endpoint for risk assessment was not identified.
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Acetic acid may be used in pesticide products and nonpesticide
products that may be used around the home. Since an endpoint for risk
assessment was not identified, a quantitative residential exposure
assessment for acetic acid was not conducted.
    3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found acetic acid to share a common mechanism of
toxicity with any other substances, and acetic acid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetic acid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    As part of its qualitative assessment, the Agency did not use
safety factors for assessing risk, and no additional safety factor is
needed for assessing risk to infants and children. Based on an
assessment of acetic acid and its chemical properties, EPA has
concluded that there are no toxicological endpoints of concern for the
U.S. population, including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA
concludes that aggregate exposure to residues of acetic acid will not
pose a risk to the U.S. population, including infants and children, and
that there is a reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to acetic acid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance. EPA is establishing a limitation on the amount of acetic
acid that may be used in pesticide formulations.
    The limitation will be enforced through the pesticide registration
process under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. EPA will not register any antimicrobial
pesticide formulation used on dairy processing equipment or food-
processing

equipment and utensils for sale or distribution containing acetic acid
at ready for use end-use concentrations exceeding 1,200 parts per
million.

VI. Conclusions

    Therefore, the exemption from the requirement of a tolerance for
acetic acid when used as an inert ingredient in antimicrobial pesticide
formulations used on dairy-processing equipment, food-processing
equipment, and utensils under 40 CFR 180.940(b) and (c) are amended by
an increase in the use limitation from 686 ppm to 1,200 ppm.

VII. Statutory and Executive Order Reviews

    This action amends exemptions from the requirement of a tolerance
under FFDCA section 408(d) in response to a petition submitted to the
Agency. 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). 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 exemption in this
final rule, 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, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 Agency 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).

VIII. 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: July 30, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. In Sec.  180.940(b) and (c), revise the entry for ``Acetic acid'' to
read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (b) * * *

------------------------------------------------------------------------
       Pesticide chemical          CAS Reg. No.           Limits
------------------------------------------------------------------------
Acetic acid....................         64-19-7   When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 1200 ppm.

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

    (c) * * *

------------------------------------------------------------------------
       Pesticide chemical          CAS Reg. No.           Limits
------------------------------------------------------------------------
Acetic acid....................         64-19-7   When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 1,200 ppm.

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

[FR Doc. 2015-20001 Filed 8-13-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Rules and Regulations]
[Pages 62449-62450]
[FR Doc No: 2015-25853]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0967; Airspace Docket No. 14-ASO-19]

Amendment of Class E Airspace; Ponce, PR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E Airspace at Ponce, PR, as the PONCE
VHF Omni-Directional Radio Range Tactical Air Navigation Aid, (VORTAC)
has been decommissioned, requiring airspace redesign at Mercedita
Airport. This action enhances the safety and management of Instrument
Flight Rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, December 10, 2015. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Z, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. For further information, you can
contact the Airspace Policy and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC, 20591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace at Mercedita Airport, Ponce, PR.

 History

    On July 16, 2015, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E surface area
airspace at Mercedita Airport, Ponce, PR, due to the decommissioning of
the Ponce VORTAC (80 FR 42068). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6002 of
FAA Order 7400.9Z dated August 6, 2015, and effective September 15,
2015, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Z, airspace Designations and
Reporting Points, dated August 6, 2015, and effective September 15,
2015. FAA Order 7400.9Z is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B,
C, D, and E airspace areas, air traffic service routes, and reporting
points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E surface area airspace at Mercedita Airport,
Ponce, PR.
    Airspace reconfiguration to within a 4.1-mile radius of the airport
is necessary due to the decommissioning of the Ponce VORTAC and
cancellation of the VOR approach, and for continued safety and
management of IFR operations at the airport.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion

under the National Environmental Policy Act in accordance with FAA
Order 1050.1E, ``Environmental Impacts: Policies and Procedures,''
paragraph 311a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71 --DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS;
AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting Points, dated August 6, 2015,
effective September 15, 2015, is amended as follows:

Paragraph 6002 Class E Airspace Designated as Surface Areas

* * * * *

ASO PR E2 Ponce, PR [Amended]

Mercedita Airport, PR
    (Lat. 18[deg]00'30'' N., long. 66[deg]33'47'' W.)

    Within a 4.1-mile radius of Mercedita Airport. This Class E
airspace is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

    Issued in College Park, Georgia, on October 2, 2015.
Gerald E. Lynch,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2015-25853 Filed 10-15-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)]
[Notices]
[Page 31768]
[FR Doc No: 2017-14335]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13102-003]

Birch Power Company; Notice of Availability of Draft
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission or FERC)
regulations, 18 Code of Federal Regulations Part 380, Office of Energy
Projects staff has reviewed the application for original license for
the Demopolis Lock and Dam Hydroelectric Project (FERC No. 13102-003)
on the Tombigbee River.
    The Demopolis Lock and Dam Hydroelectric Project would be located
at an existing lock and dam owned by the U.S. Army Corps of Engineers
on the Tombigbee River, west of the city of Demopolis in Marengo and
Sumter Counties, Alabama. The project would occupy 23 acres of federal
land.
    Staff has prepared this draft environmental assessment (draft EA)
that analyzes the potential environmental effects of the project and
concludes that constructing and operating the project, with appropriate
environmental protection measures, would not constitute a major federal
action that would significantly affect the quality of the human
environment.
    A copy of the draft EA is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
at www.ferc.gov using the ``eLibrary'' link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,
(202) 502-8659.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    Any comments should be filed within 30 days from the date of this
notice. The Commission strongly encourages electronic filing. Please
file comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. In lieu of electronic filing,
please send a paper copy to: Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426. The first page
of any filing should include: ``Demopolis Lock and Dam Hydroelectric
Project No. 13102-003.''
    For further information, contact Adam Peer at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
    Dated: June 29, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-14335 Filed 7-7-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: February 12, 2008 (Volume 73, Number 29)]
[Notices]
[Page 8037-8038]
[DOCID:fr12fe08-18]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2232]

Duke Energy Corporation; Notice of Availability of Environmental
Assessment

February 6, 2008.
    In accordance with the National Environmental Policy Act of 1969,
as amended, and the Federal Energy Regulatory Commission's (Commission)
regulations (18 CFR Part 380), Commission staff has reviewed plans,
filed May 16, 2007, to perform embankment seismic stability improvement
work at Catawba Dam, part of the Catawba-Wateree Project's Bridgewater
Development, which is located on the Catawba River in McDowell and
Burke counties, North

Carolina. The project occupies nine counties in North Carolina and five
counties in South Carolina.
    The project licensee, Duke Energy Corporation (Duke Power), plans
to add an earthfill berm to the downstream side of the embankment of
Catawba Dam because it has been determined that the dam could fail
during a seismic event. Accordingly, the Commission required
remediation under Part 12 of its regulations. In the environmental
assessment (EA), Commission staff has analyzed the probable
environmental effects of the proposed work and has concluded that
approval, with appropriate environmental measures, would not constitute
a major Federal action significantly affecting the quality of the human
environment.
    A copy of the EA is available for review at the Commission's Public
Reference Room, or it may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``elibrary'' link. Enter the docket

number (P-2232) in the docket number field to access the document. For
assistance, call<PHONE_NUMBER>, or<PHONE_NUMBER> (for TTY).

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-2527 Filed 2-11-08; 8:45 am]

BILLING CODE 6717-01-P