[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53100]
[FR Doc No: 2021-20709]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4532-DR; Docket ID FEMA-2021-0001]

Vermont; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Vermont (FEMA-4532-DR), dated April 8, 2020, and
related determinations.

DATES: This amendment was issued August 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
dated April 8, 2020 for the State of Vermont is hereby amended to
include the Hazard Mitigation Grant Program.

    All areas within the State of Vermont are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-20709 Filed 9-23-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Pages 55010-55011]
[FR Doc No: 2022-19410]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1275]

General Clinical Pharmacology Considerations for Pediatric
Studies of Drugs, Including Biological Products; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``General Clinical Pharmacology Considerations for Pediatric Studies of
Drugs, Including Biological Products,'' replacing the December 2014
draft guidance of the same name. This draft guidance, once finalized,
will assist sponsors of investigational new drug applications (INDs)
and applicants of new drug applications (NDAs), biologics license
applications (BLAs), and supplements to such applications, who are
planning to conduct clinical studies in pediatric populations. In
addition, this draft guidance, once finalized, will assist
investigators in the design and planning of, and Institutional Review
Boards in the assessment of, clinical studies in pediatric populations.

DATES: Submit either electronic or written comments on the draft
guidance by December 7, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2013-D-1275 for ``General Clinical Pharmacology Considerations for
Pediatric Studies of Drugs and Biological Products.'' Received comments
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.
     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.'' The Agency 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 to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elimika Pfuma Fletcher, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2162,

Silver Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``General Clinical Pharmacology Considerations for
Pediatric Studies of Drugs, Including Biological Products.''
Effectiveness, safety, or dose-finding studies in pediatric patients
involve gathering clinical pharmacology information, such as
information regarding a product's pharmacokinetics and
pharmacodynamics, to inform dose selection and individualization. This
draft guidance addresses general clinical pharmacology considerations
for conducting studies so that the dosing and safety information for
drugs and biological products in pediatric populations can be
sufficiently characterized, leading to well-designed trials to evaluate
effectiveness.
    In general, this draft guidance focuses on the clinical
pharmacology information (e.g., exposure-response, pharmacokinetics,
and pharmacodynamics) that supports findings of effectiveness and
safety and helps identify appropriate doses in pediatric populations.
This draft guidance also describes how quantitative approaches (i.e.,
pharmacometrics) can use disease and exposure-response knowledge from
relevant prior clinical studies to help design and evaluate future
pediatric studies.
    This draft guidance revises the draft guidance, ``General Clinical
Pharmacology Considerations for Pediatric Studies of Drugs and
Biological Products,'' issued on December 9, 2014 (79 FR 73079). This
draft guidance provides clarification on clinical pharmacology studies
in pediatric patients from the 2014 draft guidance in response to
public comments.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``General
Clinical Pharmacology Considerations for Pediatric Studies of Drugs and
Biological Products.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved FDA collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of
information for the submission of new drug applications in 21 CFR part
314 have been approved under OMB control number 0910-0001. The
collections of information for the submission of biologics license
applications in 21 CFR part 601 have been approved under OMB control
number 0910-0338. The collections of information for the submission of
investigational new drug applications in 21 CFR part 312 have been
approved under OMB control number 0910-0014. The collections of
information for the protection of human subjects and institutional
review boards in parts 21 CFR parts 50 and 56 have been approved under
OMB control number 0910-0130. The collections of information for the
submission of prescription drug product labeling in 21 CFR 201.56 and
201.57 have been approved under OMB control number 0910-0572. The
collections of information in 21 CFR 312.47 and 312.82 for requesting
meetings with FDA about drug development programs have been approved
under OMB control number 0910-0429.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19410 Filed 9-7-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 28, 2006 (Volume 71, Number 82)]
[Notices]
[Page 25254-25256]
[DOCID:fr28ap06-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53708; File No. SR-Amex-2005-116]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of a Proposed Rule Change and Amendment No. 1 Thereto
Relating to Written Compliance and Supervisory Controls

April 24, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''), \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 7, 2005, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. Amex
filed Amendment No. 1 with the Commission on April 6, 2006.\3\ The
Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Amendment No. 1.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Amex Rule 320 to (1) require members
and member organizations with employees to establish, maintain, enforce
and keep current a system of compliance and supervisory controls
reasonably designed to achieve compliance with applicable securities
laws and regulations and Exchange rules, and (2) make certain other
technical changes to the rule text.
    The text of the proposed rule change is available on the Amex's Web
site at http://www.amex.com, at the Amex's Office of the Secretary, and

at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Amex included statements
concerning the purpose of and basis for the proposal and discussed any
comments it received on the proposal. The text of these statements may
be examined at the places specified in Item IV below. Amex has prepared
summaries, set forth in sections A, B, and C below, of the

most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Amex Rule 320 currently requires each office, department or
business activity of a member or member organization to be under the
supervision and control of the member or member organization, and it
also mandates that each member or member organization provide for
appropriate supervisory and control procedures and designate
appropriately qualified personnel to ensure that its business complies
with securities laws and regulations. The purpose of this proposal is
to amend Amex Rule 320 to require members and member organizations that
have employees to adopt a system of compliance and supervisory
controls, including written compliance and supervisory policies and
procedures.
    Specifically, Amex proposes to add a new section (e) to Amex Rule
320, and consequently re-designate existing section (e) as section (f),
to require that members and member organizations with employees must
establish, maintain, enforce and keep current compliance and
supervisory control systems appropriate to their business size,
structure, customer accounts, transactions and business activities.
Proposed Amex Rule 320(e) would require that the written compliance and
supervisory procedures be amended, as appropriate and within a
reasonable time, to reflect changes in applicable securities laws and
regulations, Exchange rules, and the member's or member organization's
compliance and supervisory system. Additionally, under proposed Amex
Rule 320(e), the individual designated pursuant to Amex Rule 320(c) to
assume authority and responsibility for the member's or member
organization's compliance with securities laws, regulations and
Exchange rules would be required to provide reports, at least annually,
to the member's or member organization's senior management summarizing:
(1) The system of supervisory controls, (2) the system of follow-up and
review to verify that any delegated authority and responsibility is
being properly exercised, (3) any additional or amended compliance or
supervisory programs that have been created and implemented during the
course of the previous twelve months, and (4) any supervisory
procedures created as a result of changes in the system of follow up
and review that have been revised or added in the past twelve months.
    The Exchange also proposes to adopt new Commentary .08 to Amex Rule
320 to provide that a member or member organization consisting of a
single individual (for example, a sole proprietorship) must maintain a
written compliance manual specifying (1) the obligations to which such
member or member organization is subject under applicable securities
laws and regulations and Exchange rules and (2) the processes and
controls in place that are reasonably designed to achieve compliance
with such obligations. Because these members and member organizations
do not have employees to supervise, proposed Amex Rule 320(e) would not
require that they establish or maintain either a system of supervisory
controls or written supervisory policies and procedures, or that they
implement annual reporting requirements to the member's or member
organization's senior management concerning supervisory controls.
    The Exchange also proposes to amend sections (b) and (c) of Amex
Rule 320 to include references to compliance with Exchange rules, in
addition to the current references to compliance with securities laws
and regulations, in order to explicitly reference a member's and member
organization's obligation to comply with Exchange rules in addition to
all applicable securities laws and regulations.
    Finally, the Exchange proposes technical conforming changes to: (1)
Replace references to ``member firm'' with a reference to ``member
organization,'' and (2) clarify references to ``member organization''
as applying to ``member or member organization,'' as appropriate,
throughout Amex Rule 320.
2. Statutory Basis
    Amex believes that the proposed rule change is consistent with
section 6(b) of the Act,\4\ in general, and furthers the objectives of
section 6(b)(5) of the Act,\5\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, and, in general, to protect
investors and the public interest.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that the proposed rule change does not impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, as amended, or
    (B) Institute proceedings to determine whether the proposed rule
change, as amended, should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Amex-2005-116 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Amex-2005-116. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the

proposed rule change between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of the filing
also will be available for inspection and copying at the principal
office of the Exchange. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-Amex-2005-116 and should be submitted on or before May 19, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-6412 Filed 4-27-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Rules and Regulations]
[Pages 44712-44718]
[FR Doc No: 2019-18362]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0093; FRL-9996-95]

Oxirane, 2-methyl-, Polymer With Oxirane, Monoundecyl Ether,
Branched and Linear; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of oxirane, 2-methyl-, polymer with
oxirane, monoundecyl ether, branched and linear (CAS Reg. No. 2222805-
23-2) when used as an inert ingredient in a pesticide chemical
formulation. Exponent, Inc. on behalf of Clariant Corporation submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an amendment to an existing requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of oxirane, 2-methyl-, polymer with
oxirane, monoundecyl ether, branched and linear.

DATES: This regulation is effective August 27, 2019. Objections and
requests for hearings must be received on or before October 28, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0093, 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: Michael Goodis, 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 Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0093 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 28, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0093, 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 August 5, 2009 (74 FR 38935) (FRL-8430-
1), EPA issued a final rule, announcing the establishment of a
tolerance exemption pursuant to a pesticide petition (PP 9E7534) by The
Joint Inerts Task Force, Cluster Support Team 1 (CST 1), c/o CropLife
America, 1156 15th Street NW, Suite 400, Washington, DC 20005. The
petition requested that 40 CFR 180.910, 180.930, 180.940(a) and 180.960
be amended by establishing an exemption from the requirement of a
tolerance for residues of a group of substances known as [alpha]-alkyl-
[omega]-hydroxypoly(oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of 6 carbons, herein referred
to in this document as AAA.
    The current petition seeks to expand the exemptions for AAA by
adding additional CAS Reg. Nos. In the Federal Register of May 13, 2019
(84 FR 20843) (FRL-9991-91), EPA issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing the filing of a pesticide
petition (PP IN-11254) by Exponent Inc. on behalf of Clariant
Corporation, Suite 1100, 1150 Connecticut Avenue NW, Washington DC
20036. The petition requested that 40 CFR 180.910, 180.930, 180.940(a)
and 180.960 be amended by establishing an exemption from the
requirement of a tolerance for residues of oxirane, 2-methyl-, polymer
with oxirane, monoundecyl ether, branched and linear (CAS Reg. No.
2222805-23-2). That document referenced a summary of the petition
prepared by Exponent, the petitioner, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
confirmed that the requested CAS Reg. No. is acceptable for
consideration under the currently approved descriptor. This
determination is based on the Agency's risk assessment which can be
found at http://www.regulations.gov in document ``Alkyl Alcohol
Alkoxylates (AAA-JITF CST 1 Inert Ingredient), Human Health Risk
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance under 40 CFR 180.960 when used as an Inert Ingredient in
Pesticide Formulations'' in docket ID number EPA-HQ-OPP-2009-0145.

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 oxirane, 2-methyl-, polymer
with oxirane, monoundecyl ether, branched and linear including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with oxirane, 2-methyl-,
polymer with oxirane, monoundecyl ether, branched and linear 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 AAA 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 the final rule
published in the Federal Register of August 5, 2009 (74 FR 38935) (FRL-
8430-1).

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.
    A summary of the toxicological endpoints for AAA used for human
risk assessment is discussed in Unit IV of the final rule published in
the Federal Register of August 5, 2009 (74 FR 38938) (FRL-8430-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to AAA, EPA considered exposure under the proposed exemption
from the requirement of a tolerance. EPA assessed dietary exposures
from AAA in food as follows:
    i. Acute exposure. No adverse effects attributable to a single
exposure of the AAAs was seen in the toxicity databases. Therefore,
acute dietary risk assessments for the AAAs are not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994 -1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII).
    iii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. The AAAs are not expected to be
carcinogenic. Therefore, a cancer dietary exposure assessment is not
necessary to assess cancer risk.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for the AAAs in drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). The AAAs may be used
in inert ingredients in pesticide products that are registered for
specific uses that may result in both indoor and outdoor residential
exposures. A screening level residential exposure and risk assessment
was completed for products containing the AAAs as inert ingredients.
    4. 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 AAA to share a common mechanism of toxicity with
any other substances, and AAA does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that AAA 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 website 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 FQPA Safety
Factor (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.
    2. Prenatal and postnatal sensitivity. In the case of the lower
weight AAA surfactants, there was no evidence of increased
susceptibility to the offspring of rats following prenatal and
postnatal exposure in the reproductive/developmental screening studies
on several representative AAA surfactants. Decreased litter size and
increased post-implantation loss were observed in one OPPTS Harmonized
Guideline 870.3550 reproduction/developmental toxicity screening study
at 470 mg/kg/day where maternal/paternal toxicity was manifested as one
maternal death (GD

22), decreased body weight, bodyweight gain and food consumption and
clinical signs (ptosis and hypoactivity) and microscopic changes in the
testes (atrophy) and epididymides (increased intraluminal exfoliated
spermatogenic cells) and dilated seminiferous tubules at the same dose
(470 mg/kg/day). The maternal and offspring toxicity NOAEL was 168 mg/
kg/day. The offspring toxicity in the OPPTS Harmonized Test Guideline
870.3650 study was manifested in the presence of more severe maternal
toxicity (deaths), therefore, EPA concluded that there is no evidence
of increased susceptibility in this study. In addition, there was no
evidence of increased susceptibility in other submitted studies.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for the lower weight AAAs. (As discussed
earlier, given the low toxicological concerns with the high weight
AAAs, a safety factor analysis is unnecessary).

E. Aggregate Risks and Determination of Safety Determination of Safety
Section

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
AAA is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for chronic exposure the chronic dietary exposure from food and water
to the AAAs is 11% of the cPAD for the U.S. population and 37% of the
cPAD for children 1 to 2 years old, the most highly exposed population
subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    AAAs are used as inert ingredients in pesticide products that are
currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to the AAAs. EPA has concluded that
the combined short-term aggregated food, water, and residential
exposures result in aggregate MOEs of 110 for both adult males and
females. Adult residential exposure combines high end indoor inhalation
handler exposure with a high-end post application to pet exposures. EPA
has concluded the combined short-term aggregated food, water, and
residential exposures result in an aggregate MOE of 110 for children.
Children's residential exposure includes total combined pet exposures.
As the level of concern is for MOEs that are lower than 100, these MOEs
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    The AAAs are used as inert ingredients in pesticide products that
are currently registered for uses that could result in intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
intermediate-term residential exposures to the AAAs. EPA has concluded
that the combined intermediate-term aggregated food, water, and
residential exposures result in aggregate MOEs of 230 for both adult
males and females, respectively. Adult residential exposure includes
high-end post application dermal exposure from contact with treated
pets. EPA has concluded that the combined intermediate-term aggregated
food, water, and residential exposures result in an aggregate MOE of
110 for children. Children's residential exposure includes total
combined pet exposure. As the level of concern is for MOEs that are
lower than 100, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to the AAAs.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of the lower weight AAAs. For the high molecular
weight AAAs under 40 CFR 180.960. Since AAA conforms to the criteria
that identify a low-risk polymer, there are no concerns for risks
associated with any potential exposure scenarios that are reasonably
foreseeable. Therefore, EPA concludes that there is a reasonable
certainty that no harm will result to the general population or to
infants and children from aggregate exposure to residues of the high
molecular weight AAAs.

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 without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for AAAs.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established for residues of the lower molecular weight [alpha]-alkyl-
[omega]-hydroxypoly(oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of 6 carbons, including
oxirane, 2-methyl-, polymer with oxirane, monoundecyl ether, branched
and linear (CAS Reg. No. 2222805-23-2) when used as an inert ingredient
in pesticide formulations applied to pre- and post-harvest, applied to
livestock, and used in antimicrobial formulations under 40 CFR 180.910,
40 CFR 180.930, and 40 CFR 180.940(a). In addition, an

exemption from the requirement of a tolerance is established for
residues of the larger molecular weight compounds of a-alkyl-w-
hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the
alkyl chain contains a minimum of 6 carbons, including oxirane, 2-
methyl-, polymer with oxirane, monoundecyl ether, branched and linear
(CAS Reg. No. 2222805-23-2) under 40 CFR 180.960.

VII. Statutory and Executive Order Reviews

    This action establishes 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 tolerance 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: August 16, 2019.
Daniel Rosenblatt,
Acting 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.  180.910, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of six carbons'' in the table
to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
            Inert ingredients                 Limits          Uses
------------------------------------------------------------------------

                              * * * * * * *
[alpha]-Alkyl-[omega]-hydroxypoly          ...........  Surfactants,
 (oxypropylene) and/or poly (oxyethylene)                related
 polymers where the alkyl chain contains                 adjuvants of
 a minimum of six carbons (CAS Reg. Nos.:                surfactants
 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 24938-91-8; 25231-21-4; 251553-55-6;
 26183-52-8; 26468-86-0; 26636-39-5;
 27252-75-1; 27306-79-2; 31726-34-8;
 34398-01-1; 34398-05-5; 37251-67-5;
 37311-00-5; 37311-01-6; 37311-02-7;
 37311-04-9; 39587-22-9; 50861-66-0;
 52232-09-4; 52292-17-8; 52609-19-5;
 57679-21-7; 59112-62-8; 60828-78-6;
 61702-78-1; 61723-78-2; 61725-89-1;
 61791-13-7; 61791-20-6; 61791-28-4;
 61804-34-0; 61827-42-7; 61827-84-7;
 62648-50-4; 63303-01-5; 63658-45-7;
 63793-60-2; 64366-70-7; 64415-24-3;
 64415-25-4; 64425-86-1; 65104-72-5;
 65150-81-4; 66455-14-9: 66455-15-0;
 67254-71-1; 67763-08-0; 68002-96-0;
 68002-97-1; 68131-39-5; 68131-40-8;
 68154-96-1; 68154-97-2; 68154-98-3;
 68155-01-1; 68213-23-0; 68213-24-1;
 68238-81-3; 68238-82-4; 68409-58-5;
 68409-59-6; 68439-30-5; 68439-45-2;
 68439-46-3; 68439-48-5; 68439-49-6;
 68439-50-9; 68439-51-0; 68439-53-2;
 68439-54-3; 68458-88-8; 68526-94-3;
 68526-95-4; 68551-12-2; 68551-13-3;
 68551-14-4; 68603-20-3; 68603-25-8;
 68920-66-1; 68920-69-4; 68937-66-6;
 68951-67-7; 68954-94-9; 68987-81-5;
 68991-48-0; 69011-36-5; 69013-18-9;
 69013-19-0; 69227-20-9; 69227-21-0;
 69227-22-1; 69364-63-2; 70750-27-5;
 70879-83-3; 70955-07-6; 71011-10-4;
 71060-57-6; 71243-46-4; 72066-65-0;
 72108-90-8; 72484-69-6; 72854-13-8;
 72905-87-4; 73018-31-2; 73049-34-0;
 74432-13-6; 74499-34-6; 78330-19-5;
 78330-20-8; 78330-21-9; 78330-23-1;
 79771-03-2; 84133-50-6; 85422-93-1;
 97043-91-9; 97953-22-5; 102782-43-4;
 103331-86-8; 103657-84-7; 103657-85-8;
 103818-93-5; 103819-03-0; 106232-83-1;
 111905-54-5; 116810-31-2; 116810-32-3;
 116810-33-4; 120313-48-6; 120944-68-5;
 121617-09-2; 126646-02-4; 126950-62-7;
 127036-24-2; 139626-71-4; 152231-44-2;
 154518-36-2; 157627-86-6; 157627-88-8;
 157707-41-0; 157707-43-2; 159653-49-3;
 160875-66-1; 160901-20-2; 160901-09-7;
 160901-19-9; 161025-21-4; 161025-22-5;
 166736-08-9; 169107-21-5; 172588-43-1;
 176022-76-7; 196823-11-7; 287935-46-0;
 288260-45-7; 303176-75-2; 954108-36-2;
 2222805-23-2).

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

0
3. In Sec.  180.930, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of six carbons'' in the table
to read as follows:

Sec.  180.930   Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
            Inert ingredients                 Limits          Uses
------------------------------------------------------------------------

                              * * * * * * *
[alpha]-Alkyl-[omega]-hydroxypoly          ...........  Surfactants,
 (oxypropylene) and/or poly (oxyethylene)                related
 polymers where the alkyl chain contains                 adjuvants of
 a minimum of six carbons (CAS Reg. Nos.:                surfactants
 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 24938-91-8; 25231-21-4; 251553-55-6;
 26183-52-8; 26468-86-0; 26636-39-5;
 27252-75-1; 27306-79-2; 31726-34-8;
 34398-01-1; 34398-05-5; 37251-67-5;
 37311-00-5; 37311-01-6; 37311-02-7;
 37311-04-9; 39587-22-9; 50861-66-0;
 52232-09-4; 52292-17-8; 52609-19-5;
 57679-21-7; 59112-62-8; 60828-78-6;
 61702-78-1; 61723-78-2; 61725-89-1;
 61791-13-7; 61791-20-6; 61791-28-4;
 61804-34-0; 61827-42-7; 61827-84-7;
 62648-50-4; 63303-01-5; 63658-45-7;
 63793-60-2; 64366-70-7; 64415-24-3;
 64415-25-4; 64425-86-1; 65104-72-5;
 65150-81-4; 66455-14-9: 66455-15-0;
 67254-71-1; 67763-08-0; 68002-96-0;
 68002-97-1; 68131-39-5; 68131-40-8;
 68154-96-1; 68154-97-2; 68154-98-3;
 68155-01-1; 68213-23-0; 68213-24-1;
 68238-81-3; 68238-82-4; 68409-58-5;
 68409-59-6; 68439-30-5; 68439-45-2;
 68439-46-3; 68439-48-5; 68439-49-6;
 68439-50-9; 68439-51-0; 68439-53-2;
 68439-54-3; 68458-88-8; 68526-94-3;
 68526-95-4; 68551-12-2; 68551-13-3;
 68551-14-4; 68603-20-3; 68603-25-8;
 68920-66-1; 68920-69-4; 68937-66-6;
 68951-67-7; 68954-94-9; 68987-81-5;
 68991-48-0; 69011-36-5; 69013-18-9;
 69013-19-0; 69227-20-9; 69227-21-0;
 69227-22-1; 69364-63-2; 70750-27-5;
 70879-83-3; 70955-07-6; 71011-10-4;
 71060-57-6; 71243-46-4; 72066-65-0;
 72108-90-8; 72484-69-6; 72854-13-8;
 72905-87-4; 73018-31-2; 73049-34-0;
 74432-13-6; 74499-34-6; 78330-19-5;
 78330-20-8; 78330-21-9; 78330-23-1;
 79771-03-2; 84133-50-6; 85422-93-1;
 97043-91-9; 97953-22-5; 102782-43-4;
 103331-86-8; 103657-84-7; 103657-85-8;
 103818-93-5; 103819-03-0; 106232-83-1;
 111905-54-5; 116810-31-2; 116810-32-3;
 116810-33-4; 120313-48-6; 120944-68-5;
 121617-09-2; 126646-02-4; 126950-62-7;
 127036-24-2; 139626-71-4; 152231-44-2;
 154518-36-2; 157627-86-6; 157627-88-8;
 157707-41-0; 157707-43-2; 159653-49-3;
 160875-66-1; 160901-20-2; 160901-09-7;
 160901-19-9; 161025-21-4; 161025-22-5;
 166736-08-9; 169107-21-5; 172588-43-1;
 176022-76-7; 196823-11-7; 287935-46-0;
 288260-45-7; 303176-75-2; 954108-36-2;
 2222805-23-2).

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

0
4. In Sec.  180.940, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of six carbons'' in the table
in paragraph (a) to read as follows:

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

* * * * *
    (a) * * *

----------------------------------------------------------------------------------------------------------------
          Pesticide chemical                             CAS Reg. No.                             Limits
----------------------------------------------------------------------------------------------------------------

                                                 * * * * * * **
[alpha]-Alkyl-[omega]-hydroxypoly      9002-92-0; 9004-95-9; 9004-98-2; 9005-00-9; 9035- None
 (oxypropylene) and/or poly             85-2; 9038-29-3; 9038-43-1; 9040-05-5; 9043-30-
 (oxyethylene) polymers where the       5; 9087-53-0; 25190-05-0; 24938-91-8; 25231-21-
 alkyl chain contains a minimum of      4; 251553-55-6; 26183-52-8; 26468-86-0; 26636-
 six carbons.                           39-5; 27252-75-1; 27306-79-2; 31726-34-8; 34398-
                                        01-1; 34398-05-5; 37251-67-5; 37311-00-5; 37311-
                                        01-6; 37311-02-7; 37311-04-9; 39587-22-9; 50861-
                                        66-0; 52232-09-4; 52292-17-8; 52609-19-5; 57679-
                                        21-7; 59112-62-8; 60828-78-6; 61702-78-1; 61723-
                                        78-2; 61725-89-1; 61791-13-7; 61791-20-6; 61791-
                                        28-4; 61804-34-0; 61827-42-7; 61827-84-7; 62648-
                                        50-4; 63303-01-5; 63658-45-7; 63793-60-2; 64366-
                                        70-7; 64415-24-3; 64415-25-4; 64425-86-1; 65104-
                                        72-5; 65150-81-4; 66455-14-9: 66455-15-0; 67254-
                                        71-1; 67763-08-0; 68002-96-0; 68002-97-1; 68131-
                                        39-5; 68131-40-8; 68154-96-1; 68154-97-2; 68154-
                                        98-3; 68155-01-1; 68213-23-0; 68213-24-1; 68238-
                                        81-3; 68238-82-4; 68409-58-5; 68409-59-6; 68439-
                                        30-5; 68439-45-2; 68439-46-3; 68439-48-5; 68439-
                                        49-6; 68439-50-9; 68439-51-0; 68439-53-2; 68439-
                                        54-3; 68458-88-8; 68526-94-3; 68526-95-4; 68551-
                                        12-2; 68551-13-3; 68551-14-4; 68603-20-3; 68603-
                                        25-8; 68920-66-1; 68920-69-4; 68937-66-6; 68951-
                                        67-7; 68954-94-9; 68987-81-5; 68991-48-0; 69011-
                                        36-5; 69013-18-9; 69013-19-0; 69227-20-9; 69227-
                                        21-0; 69227-22-1; 69364-63-2; 70750-27-5; 70879-
                                        83-3; 70955-07-6; 71011-10-4; 71060-57-6; 71243-
                                        46-4; 72066-65-0; 72108-90-8; 72484-69-6; 72854-
                                        13-8; 72905-87-4; 73018-31-2; 73049-34-0; 74432-
                                        13-6; 74499-34-6; 78330-19-5; 78330-20-8; 78330-
                                        21-9; 78330-23-1; 79771-03-2; 84133-50-6; 85422-
                                        93-1; 97043-91-9; 97953-22-5; 102782-43-4;
                                        103331-86-8; 103657-84-7; 103657-85-8; 103818-
                                        93-5; 103819-03-0; 106232-83-1; 111905-54-5;
                                        116810-31-2; 116810-32-3; 116810-33-4; 120313-
                                        48-6; 120944-68-5; 121617-09-2; 126646-02-4;
                                        126950-62-7; 127036-24-2; 139626-71-4; 152231-
                                        44-2; 154518-36-2; 157627-86-6; 157627-88-8;
                                        157707-41-0; 157707-43-2; 159653-49-3; 160875-
                                        66-1; 160901-20-2; 160901-09-7; 160901-19-9;
                                        161025-21-4; 161025-22-5; 166736-08-9; 169107-
                                        21-5; 172588-43-1; 176022-76-7; 196823-11-7;
                                        287935-46-0; 288260-45-7; 303176-75-2; 954108-
                                        36-2; 2222805-23-2.

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

* * * * *

0
5. In Sec.  180.960, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of six carbons and a minimum
number average molecular weight (in amu) 1,100'' in the table to read
as follows:

Sec.  180.960   Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
           Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
[alpha]-Alkyl-[omega]-         9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 hydroxypoly (oxypropylene)     9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 and/or poly (oxyethylene)      05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 polymers where the alkyl       24938-91-8; 25231-21-4; 251553-55-6;
 chain contains a minimum of    26183-52-8; 26468-86-0; 26636-39-5;
 six carbons and a minimum      27252-75-1; 27306-79-2; 31726-34-8;
 number average molecular       34398-01-1; 34398-05-5; 37251-67-5;
 weight (in amu) 1,100.         37311-00-5; 37311-01-6; 37311-02-7;
                                37311-04-9; 39587-22-9; 50861-66-0;
                                52232-09-4; 52292-17-8; 52609-19-5;
                                57679-21-7; 59112-62-8; 60828-78-6;
                                61702-78-1; 61723-78-2; 61725-89-1;
                                61791-13-7; 61791-20-6; 61791-28-4;
                                61804-34-0; 61827-42-7; 61827-84-7;
                                62648-50-4; 63303-01-5; 63658-45-7;
                                63793-60-2; 64366-70-7; 64415-24-3;
                                64415-25-4; 64425-86-1; 65104-72-5;
                                65150-81-4; 66455-14-9: 66455-15-0;
                                67254-71-1; 67763-08-0; 68002-96-0;
                                68002-97-1; 68131-39-5; 68131-40-8;
                                68154-96-1; 68154-97-2; 68154-98-3;
                                68155-01-1; 68213-23-0; 68213-24-1;
                                68238-81-3; 68238-82-4; 68409-58-5;
                                68409-59-6; 68439-30-5; 68439-45-2;
                                68439-46-3; 68439-48-5; 68439-49-6;
                                68439-50-9; 68439-51-0; 68439-53-2;
                                68439-54-3; 68458-88-8; 68526-94-3;
                                68526-95-4; 68551-12-2; 68551-13-3;
                                68551-14-4; 68603-20-3; 68603-25-8;
                                68920-66-1; 68920-69-4; 68937-66-6;
                                68951-67-7; 68954-94-9; 68987-81-5;
                                68991-48-0; 69011-36-5; 69013-18-9;
                                69013-19-0; 69227-20-9; 69227-21-0;
                                69227-22-1; 69364-63-2; 70750-27-5;
                                70879-83-3; 70955-07-6; 71011-10-4;
                                71060-57-6; 71243-46-4; 72066-65-0;
                                72108-90-8; 72484-69-6; 72854-13-8;
                                72905-87-4; 73018-31-2; 73049-34-0;
                                74432-13-6; 74499-34-6; 78330-19-5;
                                78330-20-8; 78330-21-9; 78330-23-1;
                                79771-03-2; 84133-50-6; 85422-93-1;
                                97043-91-9; 97953-22-5; 102782-43-4;
                                103331-86-8; 103657-84-7; 103657-85-8;
                                103818-93-5; 103819-03-0; 106232-83-1;
                                111905-54-5; 116810-31-2; 116810-32-3;
                                116810-33-4; 120313-48-6; 120944-68-5;
                                121617-09-2; 126646-02-4; 126950-62-7;
                                127036-24-2; 139626-71-4; 152231-44-2;
                                154518-36-2; 157627-86-6; 157627-88-8;
                                157707-41-0; 157707-43-2; 159653-49-3;
                                160875-66-1; 160901-20-2; 160901-09-7;
                                160901-19-9; 161025-21-4; 161025-22-5;
                                166736-08-9; 169107-21-5; 172588-43-1;
                                176022-76-7; 196823-11-7; 287935-46-0;
                                288260-45-7; 303176-75-2; 954108-36-2;
                                2222805-23-2

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

[FR Doc. 2019-18362 Filed 8-26-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)]
[Notices]
[Pages 37499-37502]
[FR Doc No: 2017-16857]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0017]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 36 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). They are unable to meet the vision requirement in one eye for
various reasons. The exemptions will enable these individuals to
operate commercial motor vehicles (CMVs) in interstate commerce without
meeting the prescribed vision requirement in

one eye. The Agency has concluded that granting these exemptions will
provide a level of safety that is equivalent to or greater than the
level of safety maintained without the exemptions for these CMV
drivers.

DATES: The exemptions were granted June 6, 2017. The exemptions expire
on June 6, 2019.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On May 4, 2017, FMCSA published a notice of receipt of exemption
applications from certain individuals, and requested comments from the
public (82 FR 20962). That notice listed 36 applicants' case histories.
The 36 individuals applied for exemptions from the vision requirement
in 49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate
commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a two 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 two year period.
Accordingly, FMCSA has evaluated the 36 applications on their merits
and made a determination to grant exemptions to each of them.

III. Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing red, green,
and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 36
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including age-related macular degeneration, amblyopia, central
vision loss, chorioretinal scarring, choroidal neovascular membrane,
coats disease, complete loss of vision, degenerated globe, enucleation,
exotropia, glaucoma, macular scar, optic atrophy, optic nerve damage,
prosthetic eye, retinal detachment, and scarring. In most cases, their
eye conditions were not recently developed. Twenty-four of the
applicants were either born with their vision impairments or have had
them since childhood.
    The 12 individuals that sustained their vision conditions as adults
have had it for a range of 4 to 36 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 36 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision in careers ranging for 3 to 50
years. In the past three years, one driver was involved in a crash and
three drivers were convicted of moving violations in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the May 4, 2017 notice
(82 FR 20962).

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past
three years. Recent driving performance is especially important in
evaluating future safety, according to several research studies
designed to correlate past and future driving performance. Results of
these studies support the principle that the best predictor of future
performance by a driver is his/her past record of crashes and traffic
violations. Copies of the studies may be found at Docket Number FMCSA-
1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is

better than that of all CMV drivers collectively (See 61 FR 13338,
13345, March 26, 1996). The fact that experienced monocular drivers
demonstrated safe driving records in the waiver program supports a
conclusion that other monocular drivers, meeting the same qualifying
conditions as those required by the waiver program, are also likely to
have adapted to their vision deficiency and will continue to operate
safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used three consecutive
years of data, comparing the experiences of drivers in the first two
years with their experiences in the final year.
    Applying principles from these studies to the past three year
record of the 36 applicants, one driver was involved in a crash and
three drivers were convicted of moving violations in a CMV. All the
applicants achieved a record of safety while driving with their vision
impairment, demonstrating the likelihood that they have adapted their
driving skills to accommodate their condition. As the applicants' ample
driving histories with their vision deficiencies are good predictors of
future performance, FMCSA concludes their ability to drive safely can
be projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least three years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision requirement
in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the two year period allowed by 49 U.S.C.
31136(e) and 31315 to the 36 applicants listed in the notice of May 4,
2017 (82 FR 20962).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 36 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement in 49 CFR
391.41(b)(10) and (b) by a medical examiner who attests that the
individual is otherwise physically qualified under 49 CFR 391.41; (2)
that each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (3) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

V. Discussion of Comments

    FMCSA received one comment that is outside the scope of this
proceeding and will not be addressed in this notice. This one comment
was from Mr. Reginald Jackson asking ``why does any moving violations
have to stay on a CDL Driver record for three years if no one was
injured or lost there [sic] life or the CDL Driver did not receive a
citation for careless or reckless driving?'' He also asked ``If the
citation must [be] on the drivers record why it cannot [sic] be for one
year for a speeding ticket and not three years? [sic]'' Mr. Jackson
suggested ``changing the law and shorting the time down to 1 year?
[sic] '' He also suggested ``the driver can pay [a] 300 dollar fine and
not have anything be paced on his or her mvr [sic] record.''

IV. Conclusion

    Based upon its evaluation of the 36 exemption applications, FMCSA
exempts the following drivers from the vision requirement in 49 CFR
391.41(b)(10):

David A. Buchanan (SC)
Brian E. Burrows (TX)
Esta Cadet (FL)
Gary G. Colby (UT)
Herman A. Davis (AL)
Brandon G. Dills (NC)
Jeremy L. Fricke (ND)
Scott J. Geritano (NC)
Jonathen M. Gilligan (NY)
Jeffrey J. Graham (MI)
Dustin L. Hawkins (MO)
Michael S. Higham (IL)
Travis R. Honzel (CA)
Lloyd M. Hoover (PA)
Roy W. Houser, II (NC)
Maurice R. Jones, Jr. (MD)
Robert B. Jordahl (ND)
Damian Klyza (NJ)
John J. Lackey (CA)
Zachary J. McCluskey (PA)
Adam Merges (MN)
Jimmy L. Metcalf (NC)
John R. Miller (PA)
David G. Neff (KY)
Matthew J. Neufer (PA)
Vincent R. Neville (MN)
Willie L. Nez, Jr. (UT)
Kevin B. Patterson (GA)
Stuart W. Penner (KS)
Brock E. Peterson (ND)
Efren J. Soliz (NM)
Anthony J.M. Thornburg (MI)
Eric J. Wickman (MI)
Don S. Williams (AL)
Garfield M. Williams (TX)
James J. Wyles (NC)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with

the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the two year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: August 4, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-16857 Filed 8-9-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Rules and Regulations]
[Pages 56170-56172]
[FR Doc No: 2017-25613]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-1053]
RIN 1625-AA00

Safety Zone; Delaware River, Pipeline Removal, Marcus Hook, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 250-yard radius of Commerce Construction
vessels and machinery conducting diving and pipeline removal operations
in the Delaware River, in the vicinity of Anchorage 7, near Marcus
Hook, PA. The safety zone is needed to protect personnel, vessels, and
the marine environment from potential hazards created by diving and
pipeline removal operations. Entry of vessels or persons into this zone
is prohibited unless specifically authorized by the Captain of the Port
Delaware Bay.

DATES: This rule is effective without actual notice from November 28,
2017 through December 8, 2017. For the purposes of enforcement, actual
notice will be used from November 21, 2017 through November 28, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-1053 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
rulemaking, call or email Petty Officer Amanda Boone, Waterways
Management Branch, U.S. Coast Guard Sector Delaware Bay; telephone
(215) 271-4889, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because notification of this pipeline removal
project was not given to the Coast Guard until November 15, 2017. It is
impracticable to publish an NPRM because we must establish this safety
zone by November 21, 2017.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
address the potential safety hazards associated with diving and
pipeline removal operations.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Delaware Bay has determined that
potential hazards associated with diving and pipe removal operations
starting November 21, 2017, will be a safety concern for anyone within
a 250-yard radius of diving and pipe removal vessels and machinery.
This rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone while the
operations are being conducted.

IV. Discussion of the Rule

    This rule establishes a safety zone from 5:00 a.m. to 7:00 p.m.,
Monday through Sunday, from November 21, 2017 through December 8, 2017.
The safety zone will cover all navigable waters within 250 yards of
vessels and machinery being used by personnel to conduct diving and
pipe removal operations. There are three sections of pipeline that will
be removed. The first two sections of pipeline to be removed are in
Anchorage No. 7, Marcus Hook Anchorage, in the Delaware River. During
removal of these sections of pipeline, the safety zone will restrict
vessels from anchoring in the lower portion of Anchorage No. 7. During
removal of the third section of pipeline, operations will be conducted
within the main navigational channel and vessels will be required to
transit through the lower portion of Anchorage No. 7.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. Vessels wishing to transit the safety zone in the main
navigational channel may do so if they can make satisfactory passing
arrangements with the towing vessel JOKER in accordance with the
Navigational Rules in 33 CFR subchapter E via VHF-FM channel 13 or 80
at least 1 hour, as well as 30 minutes, prior to arrival to arrange
safe passage. If vessels are unable to make satisfactory passing
arrangements with the towing vessel JOKER, they may request permission
from the COTP, or his designated representative, on VHF-FM channel 16.
All vessels must operate at the minimum safe speed necessary to
maintain steerage and reduce wake. The Coast Guard will issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16, Local Notice
to Mariners, and Marine Safety Information Bulletin further defining
specific work locations and traffic patterns.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies

to control regulatory costs through a budgeting process. This rule has
not been designated a ``significant regulatory action,'' under
Executive Order 12866. Accordingly, this rule has not been reviewed by
the Office of Management and Budget (OMB), and pursuant to OMB guidance
it is exempt from the requirements of Executive Order 13771.
    This regulatory action determination is based on size, location,
duration, and time-of-day of the safety zone. Vessel traffic will be
able to safely transit around this safety zone which would impact a
small designated area of the Delaware River from 5:00 a.m. to 7:00
p.m., Monday through Sunday from November 21, 2017 through December 8,
2017 Moreover, the Coast Guard will issue a Broadcast Notice to
Mariners via VHF-FM marine channel 16, Local Notice to Mariners, and
Marine Safety Information Bulletin about the zone, and the rule would
allow vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone that will prohibit entry within 250 yards
of vessels and machinery being used by personnel to conduct diving and
pipe removal operations. It is categorically excluded from further
review under paragraph 34(g) of Figure 2-1 of the Commandant
Instruction. A Record of Environmental Consideration supporting this
determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T05-1053 to read as follows:

Sec.  165.T05-1053  Safety Zone, Delaware River; Pipeline Removal;
Marcus Hook, PA

    (a) Location. The following areas are safety zones: all navigable
waters within 250 yards of the towing vessel JOKER, Commerce
Construction crane barge KELLY, and associated diving and pipe removal
vessels, as well as any associated equipment, operating in Marcus Hook
Range and Anchorage No. 7 near Marcus Hook, PA, on the Delaware River.
    (b) Definitions. (1) Captain of the Port means the Commander,
Sector Delaware Bay or any Coast Guard commissioned,

warrant, or petty officer who has been authorized by the Captain of the
Port to act on his behalf.
    (2) Designated representative means any Coast Guard commissioned,
warrant or petty officer who has been authorized by the Captain of the
Port, Delaware Bay, to assist with the enforcement of safety zones
described in paragraph (a) of this section.
    (c) Regulations. The general safety zone regulations found in 33
CFR part 165 subpart C apply to the safety zone created by this
section.
    (1) Entry into or transiting within either safety zone is
prohibited unless vessels obtain permission from the Captain of the
Port via VHF-FM channel 16, or make satisfactory passing arrangements
via VHF-FM channels 13 or 80, with the towing vessel JOKER per this
section and the rules of the Road (33 CFR subchapter E). Vessels
requesting to transit shall contact the towing vessel JOKER on channel
13 or 80 at least 1 hour, as well as 30 minutes, prior to arrival.
    (2) Vessels granted permission to enter and transit the safety zone
must do so in accordance with any directions or orders of the Captain
of the Port, his designated representative, or the towing vessel JOKER.
No person or vessel may enter or remain in a safety zone without
permission from the Captain of the Port or the towing vessel JOKER.
    (3) There are three sections of pipeline that will be removed. The
first two sections of pipeline to be removed are in Anchorage No. 7,
Marcus Hook Anchorage, in the Delaware River. During removal of these
sections of pipeline, the safety zone will restrict vessels from
anchoring in the lower portion of Anchorage No. 7.
    (4) During removal of the third section of pipeline, operations
will be conducted within the main navigational channel and vessels will
be required to transit through the lower portion of Anchorage No. 7.
The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM
marine channel 16, Local Notice to Mariners, and Marine Safety
Information Bulletin further defining specific work locations and
traffic patterns.
    (5) All vessels must operate at the minimum safe speed necessary to
maintain steerage and reduce wake.
    (6) This section applies to all vessels that intend to transit
through the safety zone except vessels that are engaged in the
following operations: enforcement of laws, service of aids to
navigation, and emergency response.
    (d) Enforcement periods. This section will be enforced from
November 21, 2017, through December 8, 2017.

    Dated: November 20, 2017.
Scott E. Anderson,
Captain, U.S. Coast Guard, Captain of the Port, Delaware Bay.
[FR Doc. 2017-25613 Filed 11-27-17; 8:45 am]
BILLING CODE 9110-04-P