[Federal Register Volume 86, Number 58 (Monday, March 29, 2021)]
[Rules and Regulations]
[Pages 16298-16302]
[FR Doc No: 2021-06102]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Parts 153 and 157

[Docket No. RM20-18-000]

Waiver of the Water Quality Certification Requirements of Section
401(a)(1) of the Clean Water Act

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Final rule.

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

SUMMARY: In this final rule, the Federal Energy Regulatory Commission
(Commission) is amending its regulations pursuant to section 401(a)(1)
of the Clean Water Act to establish a categorial reasonable period of
time for a state or tribal certifying authority to act on a water
quality certification request for proposed natural gas and liquified
natural gas projects. The Commission is allowing certifying authorities
up to one year after receipt of a request for water quality

certification, filed in connection with a requested Commission-issued
section 7 certificate of public convenience and necessity or section 3
authorization under the Natural Gas Act, to grant or deny the request.

DATES: The rule will become effective June 28, 2021.

FOR FURTHER INFORMATION CONTACT:

David Swearingen (Technical Information), Office of Energy Projects,
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Karin Larson (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Rachael Warden (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

                                                         Paragraph Nos.

I. Background........................................                  1
II. Notice of Proposed Rulemaking....................                  4
III. Discussion......................................                  5
    A. Setting Case-by-Case Periods of Time for                        8
     Certifying Authorities To Act...................
    B. Flexibility for Certifying Authorities To Act.                 10
    C. Binding Effect on Other Agencies..............                 12
    D. Clarification of Notification in the Case of                   14
     Waiver..........................................
IV. Regulatory Requirements..........................                 16
    A. Information Collection Statement..............                 16
    B. Environmental Analysis........................                 17
    C. Regulatory Flexibility Act....................                 18
    D. Document Availability.........................                 20
    E. Effective Date and Congressional Notification.                 23

I. Background

    1. Section 401 of the Clean Water Act (CWA) \1\ is a direct grant
of authority to states \2\ to review for compliance with appropriate
federal, state, and tribal water quality requirements any discharge
into a water of the United States that may result from a proposed
activity that requires a federal license or permit. Section 401(a)(1)
of the CWA requires that an applicant for a federal license or permit
to conduct activities that may result in a discharge into the navigable
waters of the United States, such as a Federal Energy Regulatory
Commission (Commission) hydroelectric project license, or a Natural Gas
Act (NGA) certificate of public convenience and necessity for a natural
gas pipeline, or an authorization for an LNG terminal, must provide the
federal permitting agency a water quality certification from the state
in which the discharge originates or evidence of waiver thereof.\3\
Pursuant to the CWA, if the state ``fails or refuses to act on a
request for certification, within a reasonable period of time (which
shall not exceed one year) after receipt of such request,'' then
certification is waived.\4\
---------------------------------------------------------------------------

    \1\ 33 U.S.C. 1341(a)(1).
    \2\ Indian tribes that have been approved for ``treatment as a
state'' status may also have the authority under section 401 to
issue water quality certifications.
    \3\ 33 U.S.C. 1341(a)(1).
    \4\ Id.
---------------------------------------------------------------------------

    2. The Commission's practice has been to deem the one-year waiver
period to commence when the certifying agency receives the request. In
1987, the Commission promulgated subsections 4.34(b)(5)(iii) and
5.23(b)(2) \5\ of its regulations governing hydropower licensing
proceedings to provide that a certifying agency is deemed to have
waived certification if it has not denied or granted certification by
one year after the date it received a written certification request.\6\
Accordingly, subsections 4.34(b)(5)(iii) and 5.23(b)(2) \7\ of the
Commission's regulations establish for hydroelectric projects a
categorical ``reasonable period of time'' of one year.
---------------------------------------------------------------------------

    \5\ 18 CFR 4.34(b)(5)(iii) and 5.23(b)(2). Part 4 of the
Commission's regulations governs applicants using the traditional
licensing process and part 5 governs applicants using the integrated
license application process.
    \6\ Waiver of the Water Quality Certification Requirements of
Section 401(a)(1) of the Clean Water Act, Order No. 464, FERC Stats.
& Regs. ] 30,730 (1987) (cross-referenced at 38 FERC ] 61,146).
    \7\ 18 CFR 4.34(b)(5)(iii) and 5.23(b)(2).
---------------------------------------------------------------------------

    3. While no comparable regulation exists for NGA infrastructure
proceedings, the Commission's practice is to also categorically apply a
one-year waiver period for water quality certification applications
filed in connection to a proposed natural gas or liquefied natural gas
infrastructure project application.\8\
---------------------------------------------------------------------------

    \8\ Constitution Pipeline Co., LLC, 162 FERC ] 61,014, at P 16
(explaining that since 1987 the Commission has consistently
determined, both by regulation and in our orders on proposed
projects, that the reasonable period of time for action under
section 401 is one year after the date the certifying agency
receives a request for certification), reh'g denied, 164 FERC ]
61,029 (2018).
---------------------------------------------------------------------------

II. Notice of Proposed Rulemaking

    4. On September 9, 2020, the Commission issued a Notice of Proposed
Rulemaking (NOPR) proposing to codify the Commission's practice and
establish a categorical waiver period of one year for water quality
certification applications filed in connection with a proposed natural
gas or liquefied natural gas infrastructure project application.\9\ In
response to the NOPR, the Commission received five comments. The
Interstate Natural Gas Association of America (INGAA),\10\ U.S.
Department of the Interior (Interior), National Fuel Gas Supply
Corporation and Empire Pipeline, Inc. (collectively,

National Fuel),\11\ the Natural Gas Supply Association and the Center
for LNG (collectively, NGSA),\12\ and a group of state Attorneys
General (States) \13\ and California regulatory agencies (California
Water Boards) \14\ filed comments. The proposal set forth in the NOPR,
the comments received in response to the NOPR, and the Commission's
determinations are discussed below.
---------------------------------------------------------------------------

    \9\ Waiver of the Water Quality Certification Requirements of
Section 401(a)(1) of the Clean Water Act, 85 FR 66287, 172 FERC ]
61,213 (Oct. 19, 2020) (NOPR). As explained in the NOPR, part of the
impetus for establishing a categorical waiver period was the
executive order entitled Promoting Energy Infrastructure and
Economic Growth. Exec. Order 13868 of Apr. 10, 2019, 84 FR 15495
(Apr. 15, 2019). Executive Order 13868 directed the Environmental
Protection Agency (EPA) to update its regulations governing water
quality certification under CWA section 401 and mandated that
section 401 implementing agencies, such as the Commission, initiate
a rulemaking to ensure their respective agencies' regulations are
consistent with the EPA's final rule and with the policies set forth
in the executive order. 84 FR at 15496. Executive Order 13868 was
revoked on January 20, 2021, by the executive order entitled
Protecting Public Health and the Environment and Restoring Science
to Tackle the Climate Crisis. Exec. Order 13990 of Jan. 20, 2021, 86
FR 7037, 7041 (Jan. 25, 2021). Because this final rule will simply
codify the Commission's existing, long-standing practice, described
above, and is not premised on the EPA's final rule, this rule is not
affected by E.O. 13868.
    \10\ INGAA is a trade association representing 26 interstate
natural gas transmission pipeline systems.
    \11\ National Fuel Gas Supply Corporation and Empire Pipeline,
Inc., are interstate pipeline companies that own and operate
Commission-regulated pipeline facilities in New York and
Pennsylvania.
    \12\ The Natural Gas Supply Association is a trade association
focusing on the downstream natural gas industry, and the Center for
LNG is a committee of the organization that advocates for public
policies that advance the use of LNG.
    \13\ The Attorneys General of Maryland, Connecticut, Illinois,
Maine, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New
Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, and
the District of Columbia are represented in the comments.
    \14\ The California State Water Resources Control Board and the
nine California Regional Water Quality Control Boards are
represented in the comments.
---------------------------------------------------------------------------

III. Discussion

    5. The NOPR explained that the Commission believes that the
benefits of setting a categorical waiver period of one year, as
permitted by the CWA, best serves the public interest by avoiding
uncertainty associated with open-ended and varying certification
deadlines.\15\ We noted that it would be administratively inefficient
and a potential source of controversy to establish reasonable time
periods on a case-by-case basis; that state certifying agencies may
vary in terms of their procedures for reviewing requests for water
quality certification; that natural gas projects before the Commission
include highly complex proposals that may well take a state a
significant time to review; and that studies of the discharge may at
times be warranted.\16\
---------------------------------------------------------------------------

    \15\ NOPR, 172 FERC ] 61,213 at P 6 (citing Order No. 464, FERC
Stats. & Regs. ] 30,730; Constitution Pipeline Co., LLC, 162 FERC ]
61,014 at PP 16-17, 20, reh'g denied, 164 FERC ] 61,029 at P 10).
    \16\ Id.
---------------------------------------------------------------------------

    6. Given those factors, we found it reasonable to provide the
maximum time permitted under the CWA, i.e., a categorical one-year
waiver period. The Commission proposed to add this categorical one-year
waiver period to its regulations governing applications for
authorizations under sections 3 and 7 of the NGA for liquefied natural
gas and natural gas facilities in parts 153 and 157.
    7. In response to the Commission's request for comments on the
NOPR, the States and California Water Boards, NGSA, and INGAA filed
supportive comments.\17\ The States and California Water Boards agree
that requests for authorization under sections 3 and 7 of the NGA tend
to involve complex projects and support allowing certifying authorities
the maximum time permitted under the CWA to act.\18\ NGSA states that
the Commission's proposed rule will provide regulatory consistency and
certainty and agrees with the Commission's interpretation that the one-
year period for review begins upon the certifying authority's receipt
of a request for section 401 water quality certification.\19\ INGAA
comments that the proposed regulatory revisions are consistent with the
plain reading of the CWA and agrees that it would be inefficient to set
the reasonable period of time on a case-by-case basis.\20\
---------------------------------------------------------------------------

    \17\ National Fuel also supports INGAA's comments and supports
the Commission's codification of a certification period into its
regulations. National Fuel's November 18, 2020 Comments at 1.
    \18\ States and California Water Boards' November 18, 2020
Comments at 2-3. The States and California Water Boards also note
their continuing objections to the EPA's revisions under 40 CFR part
121, id. at 3-4, which are outside the scope of this NOPR and final
rule.
    \19\ NGSA's November 18, 2020 Comments at 2-9.
    \20\ INGAA's November 18, 2020 Comments at 3-4.
---------------------------------------------------------------------------

A. Setting Case-by-Case Periods of Time for Certifying Authorities To
Act

    8. National Fuel contends that the Commission need not adopt the
one-year period as its categorical reasonable period of time, arguing
that simple projects or those that do not raise significant concerns
under the CWA could merit a shorter reasonable period of time.\21\
National Fuel suggests that an applicant could assist the Commission in
identifying such suitable projects.\22\
---------------------------------------------------------------------------

    \21\ National Fuel's November 18, 2020 Comments at 2.
    \22\ Id.
---------------------------------------------------------------------------

    9. As the Commission has explained in orders on proposed projects,
the establishment of the categorical one-year waiver period confers
substantial benefits to the applicant, the certifying agency, and the
Commission, including: Avoiding the difficulty of having to construe
divergent state requirements, including what is a triggering request
for certification, which provides certainty to all parties; refraining
from intruding on states' authority to create and apply procedural
regulations; and best serving the public interest by avoiding the
uncertainty associated with varying and open-ended certification
deadlines.\23\ For those reasons, and because setting varied limits
would require additional time and potentially result in controversy, we
believe that whatever benefit may be conferred to a particular
applicant by considering an alternate waiver period on a case-by-case
basis is outweighed by the benefits described above in continuing to
adhere to the one-year waiver period. We therefore decline to entertain
the proposal to consider case-by-case alternate waiver periods.
---------------------------------------------------------------------------

    \23\ See Constitution Pipeline Co., LLC, 162 FERC ] 61,014 at PP
16-17, 20, reh'g denied, 164 FERC ] 61,029 at P 10.
---------------------------------------------------------------------------

B. Flexibility for Certifying Authorities To Act

    10. The States and California Water Boards urge the Commission to
provide certifying authorities with as much flexibility as possible in
completing their section 401 reviews.\24\
---------------------------------------------------------------------------

    \24\ States and California Water Boards' November 18, 2020
Comments at 4.
---------------------------------------------------------------------------

    11. As explained above, under the CWA, if the state ``fails or
refuses to act on a request for certification, within a reasonable
period of time (which shall not exceed one year) after receipt of such
request,'' then certification is waived.\25\ In categorically
establishing a one-year waiver period for water quality certification
applications, the Commission is providing states with the maximum time
allowed under the statute and therefore the broadest amount of
flexibility allowed under the CWA.\26\
---------------------------------------------------------------------------

    \25\ 33 U.S.C. 1341(a)(1).
    \26\ See Placer Cnty. Water Agency, 169 FERC ] 61,046 (2019)
(explaining that section 401's plain language establishes a
``bright-line rule'' that ``the timeline for a state's action
regarding a request for certification `shall not exceed one year'
after `receipt of such request' '' (quoting New York DEC v. FERC,
884 F.3d 450, 455 (2d Cir. 2018)).
---------------------------------------------------------------------------

C. Binding Effect on Other Agencies

    12. INGAA notes that other agencies ``have previously determined
that a reasonable period of time should generally be less than one
year'' and notes that the Commission's reasonable period of time cannot
bind other lead federal permitting agencies.\27\
---------------------------------------------------------------------------

    \27\ INGAA's November 18, 2020 Comments at 4-5.
---------------------------------------------------------------------------

    13. As relevant to this final rule, the Commission is the lead
federal agency for authorizations under sections 3 and 7 of the NGA for
liquefied natural gas and natural gas facilities. We recognize that
other federal agencies may be lead agency for any number of other types
of projects requiring a water quality certification under the CWA, and
we are not attempting to bind any other agency with this final rule.

D. Clarification of Notification in the Case of Waiver

    14. Interior requests clarification on what action the Commission
would take to notify or coordinate with federal agencies if the
categorical one-year waiver period set by the Commission for the
certifying authority lapses.\28\
---------------------------------------------------------------------------

    \28\ Interior's November 17, 2020 Comments at 1 (explaining that
Interior is concerned it will not have adequate information about
baseline water quality conditions and that certain statutes require
its Bureau of Land Management to prevent degradation to waters it
manages, regardless of whether a certifying authority has waived
under section 401).
---------------------------------------------------------------------------

    15. By statute, waiver is automatic.\29\ However, a state
certifying agency would be on notice that waiver occurred when the
applicant files a request for authorization to proceed with
construction in which the applicant must document that it has received
all applicable authorizations required under federal law or evidence of
waiver thereof.\30\ Interested agencies may receive filings in a
project docket, such as copies of water quality certification
applications or requests for authorization to proceed with
construction, by registering and subscribing to the project docket at
https://ferconline.ferc.gov/eSubscription.aspx. In any case, federal
agencies should take whatever steps they deem necessary to carry out
their statutory mandates, regardless of state action or inaction under
the CWA.
---------------------------------------------------------------------------

    \29\ 33 U.S.C. 1341(a)(1). If the certifying authority ``fails
or refuses to act on a request for certification, within a
reasonable period of time (which shall not exceed one year) after
receipt of such request,'' then certification is waived.
    \30\ In addition, pursuant to the EPA's regulations, 40 CFR
121.9(c), if waiver occurs, the Commission's Office of Energy
Projects will issue a notice of waiver in the FERC docket for the
applicable project.
---------------------------------------------------------------------------

IV. Regulatory Requirements

A. Information Collection Statement

    16. The Paperwork Reduction Act \31\ requires each federal agency
to seek and obtain the Office of Management and Budget's (OMB) approval
before undertaking a collection of information (i.e., reporting,
recordkeeping, or public disclosure requirements) directed to ten or
more persons or contained in a rule of general applicability. OMB
regulations require approval of certain information collection
requirements contained in final rules published in the Federal
Register.\32\ This final rule does not contain any information
collection requirements. The Commission is therefore not required to
submit this rule to OMB for review.
---------------------------------------------------------------------------

    \31\ 44 U.S.C. 3501-3521.
    \32\ See 5 CFR 1320.12.
---------------------------------------------------------------------------

B. Environmental Analysis

    17. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant effect on the human environment.\33\ The Commission
has categorically excluded certain actions from this requirement as not
having a significant effect on the human environment, including the
promulgation of rules that are clarifying, corrective, or procedural,
or that do not substantially change the effect of legislation or the
regulations being amended.\34\ This final rule proposes to
categorically establish a reasonable period of time for a certifying
agency to act on a water quality certification request for natural gas
and liquified natural gas projects with an application pending with the
Commission. Because this final rule is procedural in nature,
preparation of an Environmental Assessment or an Environmental Impact
Statement is not required.
---------------------------------------------------------------------------

    \33\ Regulations Implementing the National Environmental Policy
Act of 1969, Order No. 486, FERC Stats. & Regs. ] 30,783 (1987)
(cross-referenced at 41 FERC ] 61,284).
    \34\ 18 CFR 380.4(a)(2)(ii).
---------------------------------------------------------------------------

C. Regulatory Flexibility Act

    18. The Regulatory Flexibility Act of 1980 (RFA) \35\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
The RFA mandates consideration of regulatory alternatives that
accomplish the stated objectives of a final rule and minimize any
significant economic impact on a substantial number of small
entities.\36\ In lieu of preparing a regulatory flexibility analysis,
an agency may certify that a final rule will not have a significant
economic impact on a substantial number of small entities.\37\ The
Small Business Administration's (SBA) Office of Size Standards develops
the numerical definition of a small business.\38\ The SBA has
established a size standard for pipelines transporting natural gas,
stating that a firm is small if its annual receipts (including its
affiliates) are less than $30 million.\39\
---------------------------------------------------------------------------

    \35\ 5 U.S.C. 601-612.
    \36\ Id. 603(c).
    \37\ Id. 605(b).
    \38\ 13 CFR 121.101.
    \39\ 13 CFR 121.201, subsection 486.
---------------------------------------------------------------------------

    19. This final rule would apply to entities, a small number of
which may be small businesses, with an application for a project
pending with the Commission under section 3 or 7 of the NGA that
require a water quality certification under section 401(a)(1) of the
CWA. However, the final rule would have no effect on these entities,
regardless of their status as a small entity or not, as the rule
imposes no action or requirement on those entities. Accordingly,
pursuant to section 605(b) of the RFA, the Commission certifies that
this final rule will not have a significant economic impact on a
substantial number of small entities.

D. Document Availability

    20. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov). At
this time, the Commission has suspended access to the Commission's
Public Reference Room due to the March 13, 2020 proclamation declaring
a National Emergency concerning the Novel Coronavirus Disease (COVID-
19).
    21. From the Commission's Home Page on the internet, this
information is available on eLibrary. The full text of this document is
available on eLibrary in PDF and Microsoft Word format for viewing,
printing, and/or downloading. To access this document in eLibrary, type
the docket number excluding the last three digits of this document in
the docket number field.
    22. User assistance is available for eLibrary and the Commission's
website during normal business hours from the Commission's Online
Support at<PHONE_NUMBER> (toll free at 1-866-208-3676) or email at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
<EMAIL_ADDRESS>
E. Effective Date and Congressional Notification

    23. These regulations are effective June 28, 2021. The Commission
has determined, with the concurrence of the Administrator of the Office
of Information and Regulatory Affairs of OMB, that this rule is not a
major rule as defined in section 251 of the Small Business Regulatory
Enforcement Fairness Act of 1996.\40\ This rule is being submitted to
the Senate, House, Government Accountability Office, and Small Business
Administration.
---------------------------------------------------------------------------

    \40\ 5 U.S.C. 804(2).

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

List of Subjects

18 CFR Part 153

    Exports, Natural gas, Reporting and recordkeeping requirements.

18 CFR Part 157

    Administrative practice and procedure, Natural gas, Reporting and
recordkeeping requirements.

    By the Commission.

    Issued: Issued March 18, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

    In consideration of the foregoing, the Commission amends parts 153
and 157, chapter I, title 18, Code of Federal Regulations, as follows:

PART 153--APPLICATIONS FOR AUTHORIZATION TO CONSTRUCT, OPERATE, OR
MODIFY FACILITIES USED FOR THE EXPORT OR IMPORT OF NATURAL GAS

0
1. The authority citation for part 153 continues to read as follows:

    Authority:  15 U.S.C. 717b, 717o; E.O. 10485; 3 CFR, 1949-1953
Comp., p. 970, as amended by E.O. 12038, 3 CFR, 1978 Comp., p. 136,
DOE Delegation Order No. 0204-112, 49 FR 6684 (February 22, 1984).

0
2. Revise Sec.  153.4 to read as follows:

Sec.  153.4  General requirements.

    The procedures in Sec. Sec.  157.5, 157.6, 157.8, 157.9, 157.10,
157.11, 157.12, 157.22, and 157.23 of this chapter are applicable to
the applications described in this subpart.

PART 157--APPLICATIONS FOR CERTIFICATES OF PUBLIC CONVENIENCE AND
NECESSITY AND FOR ORDERS PERMITTING AND APPROVING ABANDONMENT UNDER
SECTION 7 OF THE NATURAL GAS ACT

0
3. The authority citation for part 157 is revised to read as follows:

    Authority:  15 U.S.C. 717-717w, 3301-3432; 33 U.S.C. 1341(a)(1);
42 U.S.C. 7101-7352.

0
4. Revise Sec.  157.22 to read as follows:

Sec.  157.22  Schedule for final decisions on a request for a Federal
authorization.

    (a) For an application under section 3 or 7 of the Natural Gas Act
that requires a Federal authorization--i.e., a permit, special use
authorization, certification, opinion, or other approval--from a
Federal agency or officer, or State agency or officer acting pursuant
to delegated Federal authority, a final decision on a request for a
Federal authorization is due no later than 90 days after the Commission
issues its final environmental document, unless a schedule is otherwise
established by Federal law.
    (b) For requests for a water quality certification submitted
pursuant to section 401(a)(1) of the Federal Water Pollution Control
Act (Clean Water Act) in connection with a project for which
authorization is sought from the Commission under section 3 or 7 of the
Natural Gas Act, the reasonable period of time during which the
certifying agency may act on the water quality certification request is
one year from the certifying agency's receipt of the request. A
certifying agency is deemed to have waived the certification
requirements of section 401(a)(1) of the Clean Water Act if the
certifying agency has not denied or granted certification by one year
after the date the certifying agency received a written request for
certification.

[FR Doc. 2021-06102 Filed 3-26-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 2, 2009 (Volume 74, Number 169)]
[Notices]
[Page 45516-45517]
[DOCID:fr02se09-104]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2009-001-N-22]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following currently
approved information collection activities. Before submitting these
information collection requirements for clearance by the Office of
Management and Budget (OMB), FRA is soliciting public comment on
specific aspects of the activities identified below.

DATES: Comments must be received no later than November 2, 2009.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 25, Washington, DC
20590, or Ms. Nakia Jackson, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB Control Number 2130-0525''
and/or ``Comments on OMB Control Number 2130-0529.'' Alternatively,
comments may be transmitted via facsimile to<PHONE_NUMBER> or (202)
493-6497, or via e-mail to Mr. Brogan at<EMAIL_ADDRESS>or to
Ms. Jackson at<EMAIL_ADDRESS>Please refer to the assigned OMB
control number in any correspondence submitted. FRA will summarize
comments received in response to this notice in a subsequent notice and
include them in its information collection submission to OMB for
approval.

FOR FURTHER INFORMATION CONTACT:
    Mr. Robert Brogan, Office of Planning and Evaluation Division, RRS-
21, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail
Stop 25, Washington, DC 20590 (telephone:<PHONE_NUMBER>) or Ms. Nakia
Jackson, Office of Information Technology, RAD-20, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC
20590 (telephone:<PHONE_NUMBER>). (These telephone numbers are not
toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, Sec.  2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A);
5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA
invites interested respondents to comment on the following summary of
proposed information collection activities regarding (i) whether the
information collection activities are necessary for FRA to properly
execute its functions, including whether the activities will have
practical utility; (ii) the accuracy of FRA's estimates of the burden
of the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for

FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(i)-(iv); 5 CFR
1320.8(d)(1)(i)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below are brief summaries of the two currently approved information
collection activities that FRA will submit for clearance by OMB as
required under the PRA:
    Title: Certification of Glazing Materials.
    OMB Control Number: 2130-0525.
    Abstract: The collection of information is set forth under 49 CFR
Part 223, which requires the certification and permanent marking of
glazing materials by the manufacturer. The manufacturer is also
responsible for making available test verification data to railroads
and FRA upon request.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Respondent Universe: 5 Manufacturers

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual burden
             CFR Section                   Respondent universe          Total annual responses       Average time per response            hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
223.17--Identification of Equipped    4 Manufacturers..............  200 stencilings/metal plates  15 minutes..................  50 hours.
 Locomotives, Passenger Cars, and
 Cabooses.
223.17--Appendix A--Requests for      5 Manufacturers..............  10 requests.................  15 minutes..................  3 hours.
 Glazing Certification Information.
--Marking Individual Units of         5 Manufacturers..............  25,000 pieces...............  480 pieces per hour.........  52 hours.
 Glazing Material.
--Testing New Material and Providing  5 Manufacturers..............  1 test......................  14 hours....................  14 hours.
 Verification Data.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Frequency of Submission: On occasion.
    Total Responses: 25,211.
    Estimated Total Annual Burden: 119 hours.
    Status: Extension of a currently approved collection.
    Title: Disqualification Proceedings.
    OMB Control Number: 2130-0529.
    Abstract: Abstract: Under 49 U.S.C. 20111(c), FRA is authorized to
issue orders disqualifying railroad employees, including supervisors,
managers, and other agents, from performing safety-sensitive service in
the rail industry for violations of safety rules, regulations,
standards, orders, or laws evidencing unfitness. FRA's regulations, 49
CFR Part 209, Subpart D, implement the statutory provision by requiring
(i) a railroad employing or formerly employing a disqualified
individual to disclose the terms and conditions of a disqualification
order to the individual's new or prospective employing railroad; (ii) a
railroad considering employing an individual in a safety-sensitive
position to ask the individual's previous employing railroad whether
the individual is currently serving under a disqualification order; and
(iii) a disqualified individual to inform his new or prospective
employer of the disqualification order and provide a copy of the same.
Additionally, the regulations prohibit a railroad from employing a
person serving under a disqualification order to work in a safety-
sensitive position. This information serves to inform a railroad
whether an employee or prospective employee is currently disqualified
from performing safety-sensitive service based on the issuance of a
disqualification order by FRA. Furthermore, it prevents an individual
currently serving under a disqualification order from retaining and
obtaining employment in a safety-sensitive position in the rail
industry.
    Form Number(s): N/A.
    Affected Public: Railroad Employees.
    Respondent Universe: 40,000 Locomotive Engineers.
    Total Responses: 3.
    Estimated Total Annual Burden: 5 hours.
    Status: Extension of a currently approved collection.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on August 27, 2009.
Donna Alwine,
Acting Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. E9-21203 Filed 9-1-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Page 5050]
[FR Doc No: 2023-01514]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96720; File No. SR-MEMX-2022-32]

Self-Regulatory Organizations; MEMX LLC; Notice of Withdrawal of
a Proposed Rule Change To Amend the Exchange's Fee Schedule To Adopt
Market Data Fees

January 20, 2023.
    On November 18, 2022, MEMX LLC (``MEMX'') filed with the Securities
and Exchange Commission (``Commission''), pursuant to section 19(b)(1)
of the Securities Exchange Act of 1934 \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend its Fee Schedule to
adopt fees for its market data products. The proposed rule change was
immediately effective upon filing with the Commission pursuant to
section 19(b)(3)(A) of the Act.\3\ The proposed rule change was
published for comment in the Federal Register on December 7, 2022.\4\
On January 17, 2023, MEMX withdrew the proposed rule change (SR-MEMX-
2022-32).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ See Securities Exchange Act Release No. 96430 (December 1,
2022), 87 FR 75083.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-01514 Filed 1-25-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22215-22217]
[FR Doc No: 2022-08022]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0470]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Cellular, Tissue and Gene
Therapies Advisory Committee. The general function of the committee is
to provide advice and recommendations to FDA on scientific issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on June 9, 2022, from 10 a.m. to 6 p.m.
and June 10, 2022, from 10 a.m. to 4 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions about FDA advisory committee meetings may be accessed
at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    The online web conference meeting will be available at the
following link on the day of the meeting: Day 1 June 9 link: https://youtu.be/RvtTK3KNl5g and Day 2 June 10 link: https://youtu.be/Eo2BXnGienc.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0470. The docket will close on June 8,
2022. Submit either electronic or written comments on this public
meeting on or before June 8, 2022. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 8, 2022. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 8, 2022. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before June 2, 2022, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-0470 for ``Cellular, Tissue and Gene Therapies Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Christina Vert or Tonica Burke, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver Spring, MD 20993-
0002, [email protected], or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be
heard, viewed, captioned, and recorded through an online
teleconferencing platform. The committee will discuss two biologics
license applications (BLAs) from bluebird bio, Inc.: (1) BLA 125755 for
elivaldogene autotemcel (autologous CD34+ stem cells genetically
modified with a lentiviral vector to contain an adenosine triphosphate-
binding cassette, sub-family D, member 1 gene that encodes a functional
adrenoleukodystrophy protein); the applicant has requested an
indication for the treatment of patients younger than 18 years of age
with early cerebral adrenoleukodystrophy who do not have an available
and willing human leukocyte antigen-matched sibling hematopoietic stem
cell donor and (2) BLA 125717 for betibeglogene autotemcel (autologous
CD34+ stem cells genetically modified with a lentiviral vector to
contain a gene encoding functional beta-globin); the applicant has
requested an indication for the treatment of patients with [beta]-
thalassemia who require regular red blood cell transfusions.
    The morning session of June 9, 2022, will include presentations of
the effectiveness and product-specific safety results from the clinical
trials in BLA 125755. The afternoon session will include presentations
of safety concerns relevant to both products, followed by committee
discussion of BLA 125755. On June 10, 2022, the morning session will
include presentations of the effectiveness and product-specific safety
results from the clinical trials in BLA 125717. The afternoon session
will include committee discussion of BLA 125717.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before June 2, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Eastern Time on June 9, 2022, and
between approximately 1 p.m. and 2 p.m. Eastern Time on June 10, 2022.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before May
25, 2022. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by May 26, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.

    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Christina Vert at [email protected] (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08022 Filed 4-13-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 111 (Thursday, June 9, 2016)]
[Notices]
[Page 37195]
[FR Doc No: 2016-13646]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Notice of Conference

------------------------------------------------------------------------
                                                   Docket Nos.
------------------------------------------------------------------------
Midwest Independent Transmission System  ER12-1265-005
 Operator, Inc.                          ER12-1265-006
Midwest Independent Transmission System  ER12-1266-005
 Operator, Inc.
------------------------------------------------------------------------

    On June 15, 2016, Commission staff will hold a conference call with
Midcontinent Independent System Operator, Inc. (MISO) beginning at
10:00 a.m. (Eastern Time). The purpose of the conference call is to
discuss tariff administration issues related to MISO's pending
compliance filings in the above-captioned proceedings to ensure that
the versions of the tariff sheets filed are accurate and complete.
    Any party, as defined by 18 CFR 385.102(c), or any participant as
defined by 18 CFR 385.102(b), is invited to listen to the conference
call. Persons wishing to become a party must move to intervene and
receive intervenor status pursuant to the Commission's regulations (18
CFR 385.214).
    The conference call will not be webcast or transcribed. However, an
audio listen-only line will be provided. Those wishing to access the
listen-only line must email Sarah McKinley<EMAIL_ADDRESS>by
5:00 p.m. (Eastern Time) on June 9, 2016, providing name, email, and
phone number, in order to receive the call-in information the day
before the conference call. Please use the following text for the
subject line: ``ER12-1266-005 listen-only line registration.''
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1 (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER>
with the required accommodations.
    For additional information, please contact Christopher Gore at
(202) 502-8507<EMAIL_ADDRESS>
    Dated: June 2, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-13646 Filed 6-8-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 239 (Thursday, December 16, 2021)]
[Notices]
[Pages 71537-71538]
[FR Doc No: 2021-27222]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0182]

Qualification of Drivers; Exemption Applications; Narcolepsy

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: FMCSA announces receipt of an application from one individual
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against operation of a commercial motor
vehicle (CMV) in interstate commerce by persons with either a clinical
diagnosis of epilepsy or any other condition that is likely to cause a
loss of consciousness or any loss of ability to control a CMV. If
granted, the exemption would enable this individual who has been
diagnosed with narcolepsy and is receiving medical treatment to operate
CMVs in interstate commerce.

DATES: Comments must be received on or before January 18, 2022.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket ID FMCSA-2021-0182 using any of the
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number, FMCSA-2021-0182, in the keyword box, and
click ``Search.'' Next, sort the results by ``Posted (Newer-Older),''
choose the first notice listed, and click on the ``Comment'' button.
Follow the online instructions for submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2021-0182), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov, insert
the docket number FMCSA-2021-0182 in the keyword box, and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, click the ``Comment'' button, and type your
comment into the text box on the following screen. Choose whether you
are submitting your comment as an individual or on behalf of a third
party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2021-0182, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE,

Washington, DC 20590-0001, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays. To be sure someone is there to
help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its regulatory process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the FMCSRs for a 5-year period if it finds such exemption would
likely achieve a level of safety that is equivalent to, or greater
than, the level that would be achieved absent such exemption. The
statute also allows the Agency to renew exemptions at the end of the
five-year period. FMCSA grants exemptions from the FMCSRs for a 2-year
period to align with the maximum duration of a driver's medical
certification.
    The individual listed in this notice has requested an exemption
from 49 CFR 391.41(b)(8). Accordingly, the Agency will evaluate the
qualifications of the applicant to determine whether granting the
exemption will achieve the required level of safety mandated by
statute.
    The physical qualification standard for drivers found in Sec.
391.41(b)(8) states that a person is physically qualified to drive a
CMV if that person has no established medical history or clinical
diagnosis of epilepsy or any other condition which is likely to cause
loss of consciousness or any loss of ability to control a commercial
motor vehicle.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist Medical Examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5.]
---------------------------------------------------------------------------

    \1\ See https://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

    The advisory criteria states that if an individual has had a sudden
episode of a non-epileptic seizure or loss of consciousness of unknown
cause that did not require anti-seizure medication, the decision
whether that person's condition is likely to cause the loss of
consciousness or loss of ability to control a CMV should be made on an
individual basis by the ME in consultation with the treating physician.
The advisory criteria also state that a variety of functional disorders
can cause drowsiness, dizziness, confusion, weakness, or paralysis that
may lead to incoordination, inattention, loss of functional control,
and susceptibility to accidents while driving.
    In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has fully recovered from that
condition, has no existing residual complications, and is not taking
anti-seizure medication.

III. Qualifications of Applicant

Sheila Bennett

    Ms. Bennett is a CMV driver in Tennessee. Ms. Bennett self-reports
that she was diagnosed with narcolepsy in early 2005, and started a
treatment plan immediately. A letter dated October 12, 2021, from Ms.
Bennett's sleep medicine provider reports that she is under care for
treatment of narcolepsy with stimulants, and that she reports her
daytime sleepiness is well-controlled on current medication.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petition
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the DATES
section of the notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-27222 Filed 12-15-21; 8:45 am]
BILLING CODE 4910-EX-P


Comment Info: =================

General Comment:A 75 day period time to review the
proposed regulations is insufficient.
We are requesting that the review period
be extended to 180 days.

Please rethink your decisions, e-cigs are healthier even if they have some type of negative effect on our health they are still healthier than cigerates.. And smell better, taste better. I can say this much about the health effects, since I quit smoking real cigerates my cardio has increased significantly. I have been a smoker for 18 years, and this has been the only thing that has kept me off of the real thing. All of the smoker cessation aids (not that this is one) has had short term effects.


[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Proposed Rules]
[Pages 55329-55332]
[FR Doc No: 2011-22845]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0082; FRL-8886-7]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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

SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before October 7, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal

holidays. The Docket Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Antimicrobials Division (7510P), Biopesticides and Pollution Prevention
Division (7511P), and Registration Division (7505P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.

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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. The Agency is taking
public comment on the requests before responding to the petitioners.
EPA is not proposing any particular action at this time. EPA has
determined that the pesticide petitions described in this document
contain the data or information prescribed in FFDCA section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the pesticide
petitions. After considering the public comments, EPA intends to
evaluate whether and what action may be warranted. Additional data may
be needed before EPA can make a final determination on these pesticide
petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerance

    1. PP 1E7863. (EPA-HQ-OPP-2011-0433). Interregional Research
Project Number 4 (IR-4), 500 College Rd. East, Suite 201 W, Princeton,
NJ 08540, requests to establish tolerances in 40 CFR part 180 for
residues of the insecticide dinotefuran, (RS)-1-methyl-2-nitro-3-
((tetrahydro-3-furyl)methyl)guanidine, including its metabolites and
degradates, in or on berry, low growing, except strawberry, subgroup
13-07H at 0.2 parts per million (ppm); watercress at 5.0 ppm; onion,
green, subgroup 3-07B at 6.0 ppm; onion, bulb, subgroup 3-07A at 0.07
ppm; peach at 0.9 ppm; vegetable, tuberous and corm, subgroup 1C at
0.05 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 0.9 ppm; and tea, plucked leaves at 25.0 ppm. Mitsui
Chemicals Agro, Inc. has submitted practical analytical methodology for
detecting and measuring levels of dinotefuran and its metabolites, 1-
methyl-3-(tetrahydro-3-furymethyl)-urea (UF) and 1-methyl-3-
(tetrahydro-3-furymethyl) guanidine (DN), in or on raw agricultural
commodities. The high performance liquid chromatography (HPLC) method
was validated for determination of dinotefuran, DN and UF in or on
tomatoes and peppers, cucurbits, brassica, grapes, potatoes, mustard
greens, and lettuce for raw agricultural commodity matrices and in or
on

tomato paste and puree, grape juice and raisins and potato chips,
granules, and wet peel for processed commodity matrices. After
extraction with a water/acetonitrile mixture and clean up with hexane
and extraction columns, concentrations of dinotefuran and its
metabolites were quantified after HPLC separation by tandem mass
spectrometry (MS/MS) detection. Contact: Sidney Jackson, (703) 305-
7610, e-mail address<EMAIL_ADDRESS>    2. PP 1E7881. (EPA-HQ-OPP-2011-0541). IR-4, 500 College Rd. East,
Suite 201 W, Princeton, NJ 08540, requests to establish tolerances in
40 CFR part 180 for combined residues of the insecticide fenpyroximate,
(E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino] oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, in or on avocado at 0.20 ppm;
sapote, black at 0.20 ppm; canistel at 0.20 ppm; sapote, mamey at 0.20
ppm; mango at 0.20 ppm; papaya at 0.20 ppm; sapodilla at 0.20 ppm; star
apple at 0.20 ppm; bean, snap at 0.40 ppm; and tea, plucked leaves at
15 ppm. An enforcement method has been developed which involves
extraction of fenpyroximate from crops with acetone, filtration,
partitioning and cleanup, and analysis by gas chromatography (GC) using
a nitrogen/phosphorous detector (NPD). Contact: Sidney Jackson, (703)
305-7610, e-mail address<EMAIL_ADDRESS>    3. PP 1E7898. (EPA-HQ-OPP-2011-0657). IR-4, 500 College Rd. East,
Suite 201 W, Princeton, NJ 08540, in cooperation with Syngenta Crop
Protection, LLC, P.O. Box 18300, Greensboro NC 27419, requests to
establish tolerances in 40 CFR part 180 for residues of the herbicide
S-metolachlor (free and bound), S-2-chloro-N-(2-ethyl-6-methylphenyl)-
N-(2-methoxy-1-methylethyl)acetamide, its R-enantiomer, and its
metabolites, determined as the derivatives, 2-(2-ethyl-6-methylphenyl)
amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, in or on cilantro, leaves, fresh at 8.0 ppm; cilantro,
leaves, dried at 8.0 ppm; coriander, seed at 0.13 ppm, and beet,
garden, leaves at 1.8 ppm. Syngenta has developed and validated
analytical methodology for enforcement purposes. This method has been
submitted to the Agency and is in Pesticide Analytical Method Vol. II
(PAM II), Method I. An extensive database of method validation data
using this method on various crop commodities is available. Contact:
Sidney Jackson,<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>    4. PP 1E7904. (EPA-HQ-OPP-2011-0665). IR-4, 500 College Rd. East,
Suite 201 W, Princeton, NJ 08540, requests to establish a tolerance in
40 CFR part 180 for residues of the insecticide emamectin benzoate, 4'-
epi-methylamino-4'-deoxyavermectin B1 benzoate (a mixture of
a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin B1a
and a maximum of 10% 4'-epi-methlyamino-4'deoxyavermectin
B1b benzoate), and its metabolites 8,9 isomer of the
B1a and B1b component of the parent insecticide,
in or on vegetable, cucurbit, group 9 at 0.03 ppm. Adequate analytical
methods (HPLC-fluorescence methods) are available for enforcement
purposes. Contact: Andrew Ertman,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    5. PP 1G7889. (EPA-HQ-OPP-2011-0674). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish
temporary tolerances in 40 CFR part 180 for residues of the fungicide
acibenzolar S-methyl for an experimental use permit (EUP), in or on
apple, grapefruit, and pears at 0.05 ppm. Syngenta Analytical Method
AG-671A is a practical and valid method for the determination and
confirmation of acibenzolar S-methyl (CGA245704) in raw agricultural
commodities (RACs) and processing substrates from the tobacco, leafy
(including Brassica) and fruiting vegetable crop groups at a limit of
quantitation (LOQ) of 0.02 ppm. The method involves extraction, solid
phase cleanup of samples with analysis by HPLC with ultraviolet (UV)
detection or confirmatory LC/MS. Contact: Rose Mary Kearns, (703) 305-
5611, e-mail address<EMAIL_ADDRESS>
Amended Tolerance

    PP 1E7881. (EPA-HQ-OPP-2011-0541). IR-4, 500 College Rd. East,
Suite 201 W, Princeton, NJ 08540, requests to amend the tolerances in
40 CFR 180.566 for combined residues of the insecticide fenpyroximate,
(E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino] oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, in or on cucumber from 0.10 ppm
to 0.25 ppm; fruit, citrus, citrus, group 10-10 tolerance at 0.60 ppm;
vegetable, fruiting, group 8-10 tolerance at 0.20 ppm; and fruit, pome,
group 11-10 tolerance at 0.40 ppm. An enforcement method has been
developed which involves extraction of fenpyroximate from crops with
acetone, filtration, partitioning and cleanup, and analysis by GC using
a nitrogen/phosphorous detector (NPD). Contact: Sidney Jackson, (703)
305-7610, e-mail address<EMAIL_ADDRESS>
New Tolerance Exemption

    PP 0F7747. (EPA-HQ-OPP-2011-0139). Pace Chemicals Ltd., 8321
Willard St., Burnaby, British Columbia, V3N 2X3, c/o Eliot Harrison,
Lewis & Harrison LLC, 122 C St. NW., Suite 740, Washington, DC 20001,
requests to establish an exemption from the requirement of a tolerance
for residues of the antimicrobial dimethyl didecyl ammonium chloride
(DDAC), in or on Brassica (broccoli seeds). DDAC was extracted from the
crop matrix with acetonitrile followed by shaking with steel balls to
pulverize the plant material. The extract was diluted with acetonitrile
and centrifuged, then evaporated to 1 milliliter (ml) under a nitrogen
stream. The extract is analyzed using LC-MS/LC. Contact: Tracy Lantz,
(703) 308-6415, e-mail address<EMAIL_ADDRESS>
Amended Tolerance Exemption

    1. PP 1E7893. (EPA-HQ-OPP-2011-0604). Cognis Corporation, c/o Lewis
& Harrison LLC, 122 C Street, NW., Suite 740, Washington, DC 20001,
requests to amend an exemption from the requirement of a tolerance in
40 CFR 180.910 and 40 CFR 180.930 to set maximum use levels of 2-
ethylhexanol (CAS No. 104-76-7) of 20% in pesticide formulations when
used as a pesticide inert ingredient. The petitioner believes no
analytical method is needed because this information is not required
for a tolerance exemption. Contact: John Redden,<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>    2. PP 1F7896. (EPA-HQ-OPP-2011-0669). AgraQuest, Inc., 1540 Drew
Ave., Davis, CA 95618, requests to amend/expand an existing exemption
from the requirement of a tolerance in 40 CFR 180.1209 by including the
residues of the microbial pesticide Bacillus subtilis strain QST 713
variant Soil when used in or on all food commodities. An analytical
method for detecting Bacillus subtilis strain QST 713 variant Soil is
not applicable. It is expected that, when used as proposed, Bacillus
subtilis strain QST 713 variant Soil would not result in residues that
are of toxicological concern. Contact: Michael Glikes,<PHONE_NUMBER>,
e-mail address<EMAIL_ADDRESS>

List of Subjects in 40 CFR Part 180

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: August 28, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-22845 Filed 9-6-11; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

			OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

MEMORANDUM							February 20, 2007

SUBJECT: 	DIETARY EXPOSURE ASSESSMENT OF COPPER NAPHTHENATE AS A WOOD
PRESERVATIVE FOR REREGISTRATION ELIGIBILITY DECISION (Case# 3099)

From:	A. Najm Shamim, PhD., Chemist

	Regulatory  Management Branch II

	Antimicrobials Division (7510P)

To:	Tim McMahon,  PhD., Senior Toxicologist and Risk Assessor

	Antimicrobials Division (7510P)

			And

	Kathryn Jakob, CRM for Copper Naphthenate

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

Thru:	Diane Isbell, Acting Team Leader,

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

			And

	Mark Hartman, Chief

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

DIETARY EXPOSURE ASSESSMENT OF COPPER NAPHTHENATE  FOR REREGISTRATION
ELEIGIBILITY DECISION(Case # 3099)

Executive Summary

In order to conduct the dietary exposure  assessment Antimicrobials does
the label database search and all those applications that involve the
indirect food contact with the pesticidal use of the specific chemical
is assessed for any dietary concerns from indirect migration of the
pesticide into foods, fruits and vegetables. In our foregoing REDs on
antimicrobials we have used with modifications Food and Drug
Administration  (FDA) methodologies.

Label searches for copper naphthenate (Case # 3099) has resulted in the
following use sites:  1) Copper naphthenate is used as a wood
preservative  when applied  through surface and pressure treatments. It
is used as a surface wrap, for above and below ground contacts  for
poles, posts, pilings, wood seals,  to treat termites, wood eating
insects. Surface treatment is through spray and or brush.

2) Wood boats, shingles, doors, windows, frames, stairs, sills, porches.
For treatments against carpenter ants, rot, fungi, mildew.

3) It is also used for marine pilings.

All the use sites listed are not likely to result in any indirect food
migration of  copper naphthenate into food, fruits or vegetable in
residential scenarios.   No estimated Daily intake (EDI) is likely to
result. AD, therefore has not conducted any dietary exposure assessment
for copper napththenate.

AD has no dietary concerns with the use patterns of copper napththenate
used primarily as a wood preservative.


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

In addition, on a more personal note, I've been a smoker for over 25 years. I have tried multiple times, utilizing "FDA approved" smoking cessation products to include, but not limited to, the patch, gum, inhaler, Wellbutrin and Chantix. Not only have they failed, but became rather ill from the "side effects", especially Chantix, which gave me nightmares and terrible mood swings. When I started using "e-cigarettes", my lungs cleared, energy returned, and overall health stabilized. During my last doctor's appointment, my blood pressure was 116/81. When discussing "e-cigarettes" with my doctor, I was applauded on quitting smoking, and that "Vaping" was a much safer alternative.

I appreciate your consideration of my request and am happy to discuss this issue with you further.