[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Proposed Rules]
[Pages 20364-20367]
[FR Doc No: 2022-07404]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2022-0179]
RIN 1625-AA08

Special Local Regulation; St. Mary's River, St. George's Creek,
Piney Point, MD

AGENCY: Coast Guard, Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish temporary special
local regulations for certain waters of the St. Mary's River. This
action is necessary to provide for the safety of life on these
navigable waters located at Piney Point, MD, during a high-speed power
boat demonstration event on June 4, 2022, and June 5, 2022. This
proposed rulemaking would prohibit persons and vessels from being in
the regulated area unless authorized by the Captain of the Port,
Maryland-National Capital Region or the Coast Guard Event Patrol
Commander. We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before May 9, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0179 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MST3 Melissa Kelly, U.S. Coast Guard
Sector Maryland-National Capital Region; telephone<PHONE_NUMBER>, 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
PATCOM Coast Guard Patrol Commander
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Southern Maryland Boat Club of Leonardtown, MD, notified the
Coast Guard that it will be conducting the Southern Maryland Boat Club
Piney Point Rumble on the River Regatta from 8 a.m. to 4 p.m. on June
4, 2022, and from 8 a.m. to 4 p.m. on June 5, 2022. The high-speed
power boat demonstration event consists of approximately 55
participating vintage and historic race boats--including runabouts, v-
bottoms, tunnel hulls, and hydroplanes--8 to 21 feet in length. The
vessels will be participating in an exhibition, operating in heats
along a marked racetrack-type course 1 mile in length and 200 feet in
width, located in the St. George Creek at Piney Point, MD. The regatta
is not a competition, but rather a demonstration of vintage race craft.
Hazards from the high-speed power boat demonstration event include
participants operating within and adjacent to designated navigation
channels and interfering with vessels intending to operate within those
channels, as well as operating near approaches to local public boat
landings. The COTP Maryland-National Capital Region has determined that
potential hazards associated with the high-speed power boat event would
be a safety concern for anyone intending to participate in this event
and for vessels that operate within specified waters of St. George
Creek.
    The purpose of this rulemaking is to protect event participants,
non-participants, and transiting vessels before, during, and after the
scheduled event. The Coast Guard is proposing this rulemaking under
authority in 46 U.S.C. 70041.

III. Discussion of Proposed Rule

    The COTP Maryland-National Capital Region proposes to establish
special local regulations from 7:30 a.m. on June 4, 2022, through 5
p.m. on June 5, 2022. The regulations would be enforced from

7:30 a.m. to 5 p.m. on June 4, 2022, and from 7:30 a.m. to 5 p.m. on
June 5, 2022. The regulated area would cover all navigable waters of
St. George Creek, within an area bounded by a line connecting the
following points: From the shoreline at Cedar Point at position
latitude 38[deg]09'03.4'' N, longitude 076[deg]29'55.7'' W; thence
south along the shoreline to Coade Bar at latitude 38[deg]08'22.5'' N,
longitude 076[deg]29'19.9'' W; thence southeast across St. George Creek
to Dodson Point at latitude 38[deg]08'03.8'' N, longitude
076[deg]29'44.6'' W; thence north along the shoreline and the eastern
extent of the St. George Island (SR-249) Bridge to Long Bar (at the
entrance to St. George Harbor) at latitude 38[deg]08'50.6'' N,
longitude 076[deg]30'13.0'' W; thence northeast across St. George Creek
to and terminating at the point of origin. The regulated area is
approximately 1,750 yards in length and 940 yards in width.
    This proposed rule provides additional information about areas
within the regulated area, and their definitions and the restrictions
that would apply to mariners. These areas include ``Race Area,''
``Buffer Area,'' and ``Spectator Area.''
    The proposed duration of the special local regulations and size of
the regulated area are intended to ensure the safety of life on these
navigable waters before, during, and after the high-speed power boat
event scheduled to take place from 8 a.m. to 4 p.m. on June 4, 2022,
and from 8 a.m. to 4 p.m. on June 5, 2022. The COTP and the Coast Guard
Event PATCOM would have authority to forbid and control the movement of
all vessels and persons, including event participants, in the regulated
area. When hailed or signaled by an official patrol, a vessel or person
in the regulated area would be required to immediately comply with the
directions given by the COTP or Event PATCOM. If a person or vessel
fails to follow such directions, the Coast Guard may expel them from
the area, issue them a citation for failure to comply, or both.
    Except for Southern Maryland Boat Club Piney Point Rumble on the
River Regatta participants and vessels already at berth, a vessel or
person would be required to get permission from the COTP or Event
PATCOM before entering the regulated area. Vessel operators would be
able to request permission to enter and transit through the regulated
area by contacting the Event PATCOM on VHF-FM channel 16. Vessel
traffic would be able to safely transit the regulated area once the
Event PATCOM deems it safe to do so. A vessel within the regulated area
must operate at safe speed that minimizes wake. A person or vessel not
registered with the event sponsor as a participant or assigned as
official patrols would be considered a spectator. Official Patrols are
any vessel assigned or approved by the Commander, Coast Guard Sector
Maryland-National Capital Region with a commissioned, warrant, or petty
officer on board and displaying a Coast Guard ensign. Official Patrols
enforcing this regulated area can be contacted on VHF-FM channel 16 and
channel 22A.
    If permission is granted by the COTP or Event PATCOM, a person or
vessel would be allowed to enter the regulated area or pass directly
through the regulated area as instructed. Vessels would be required to
operate at a safe speed that minimizes wake while within the regulated
area in a manner that would not endanger event participants or any
other craft. A spectator vessel must not loiter within the navigable
channel while within the regulated area. Official patrol vessels would
direct spectators to the designated spectator area. Only participant
vessels and official patrol vessels would be allowed to enter the race
area. The Coast Guard would publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue a marine information
broadcast on VHF-FM marine band radio announcing specific event dates
and times.
    The regulatory text we are proposing appears at the end of this
document.

IV. Regulatory Analyses

    We developed this proposed 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. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size and
duration of the regulated area, which would impact a small designated
area of St. George Creek for 19 total enforcement hours. This waterway
supports mainly recreational vessel traffic, which at its peak, occurs
during the summer season. Although this regulated area extends across
the entire width of the waterway, the rule would allow vessels and
persons to seek permission to enter the regulated area, and vessel
traffic able to do so safely would be able to transit the regulated
area on the eastern portion of the waterway away from the event area as
instructed by Event PATCOM. Such vessels must operate at safe speed
that minimizes wake and not loiter within the navigable channel while
within the regulated area. Moreover, the Coast Guard would issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
status of the regulated area.

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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    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 proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would 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 proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

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 proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination 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 proposed rule involves
implementation of regulations within 33 CFR part 100 applicable to
organized marine events on the navigable waters of the United States
that could negatively impact the safety of waterway users and shore
side activities in the event area for 19 total enforcement hours.
Normally such actions are categorically excluded from further review
under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. For instructions on locating the docket, see the
ADDRESSES section of this preamble. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2022-0179 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T05-0179 to read as follows:

Sec.  100.T05-0179  Southern Maryland Boat Club Piney Point Regatta,
St. Mary's River, St. George Creek, Piney Point, MD.

    (a) Locations. All coordinates are based on datum NAD 1983.
    (1) Regulated area. All navigable waters of St. George Creek,
within an area bounded by a line connecting the following points: From
the shoreline at Cedar Point at position latitude 38[deg]09'03.4'' N,
longitude 076[deg]29'55.7'' W; thence south along the shoreline to
Coade Bar at latitude 38[deg]08'22.5'' N, longitude 076[deg]29'19.9''
W; thence southeast across St. George Creek to Dodson Point at latitude
38[deg]08'03.8'' N, longitude 076[deg]29'44.6'' W; thence north along
the shoreline and the eastern extent of the St. George Island (SR-249)
Bridge to Long Bar (at the entrance to St. George Harbor) at latitude
38[deg]08'50.6'' N, longitude 076[deg]30'13.0'' W; thence northeast
across St. George Creek to and terminating at the point of origin. The
race area, buffer area, and spectator area are within the regulated
area.
    (2) Race area. The race area is a polygon in shape measuring
approximately 700 yards in length by 240 yards in width. The area is
bounded by a line commencing near Hodgson Point at position latitude
38[deg]08'39.80'' N, longitude 076[deg]30'3.13'' W, thence

southeast to latitude 38[deg]08'21.95'' N, longitude 076[deg]29'49.31''
W; thence southwest to latitude 38[deg]08'18.20'' N, longitude
076[deg]29'56.98'' W, thence northwest to latitude 38[deg]08'36.10'' N,
longitude 076[deg]30'10.84'' W; thence northeast to and terminating at
the point of origin.
    (3) Buffer area. The buffer area is a polygon in shape measuring
approximately 90 yards in all directions surrounding the entire race
area described in paragraph (a)(2) of this section. The area is bounded
by a line commencing near Hodgson Point at position latitude
38[deg]08'43.58'' N, longitude 076[deg]30'02.12'' W; thence southeast
to latitude 38[deg]08'21.12'' N, longitude 076[deg]29'44.81'' W, thence
southwest to latitude 38[deg]08'14.68'' N, longitude 076[deg]29'58.24''
W; thence northwest to latitude 38[deg]08'35.95'' N, longitude
076[deg]30'14.33'' W, thence northeast to and terminating at the point
of origin.
    (4) Spectator area. The designated spectator area is a polygon in
shape with its length measuring approximately 700 yards and its width
measuring approximately 300 yards at its northern portion and 150 yards
at it southern portion. The area is bounded by a line commencing at
position latitude 38[deg]08'46.86'' N, longitude 076[deg]29'51.07'' W;
thence southeast to latitude 38[deg]08'38.11'' N, longitude
076[deg]29'44.27'' W; thence south to latitude 38[deg]08'26.81'' N,
longitude 076[deg]29'43.01'' W; thence southwest to latitude
38[deg]08'23.50'' N, longitude 076[deg]29'46.50'' W, thence northwest
to latitude 38[deg]08'41.28'' N, longitude 076[deg]30'00.18'' W, thence
northeast to and terminating at the point of origin.
    (b) Definitions. As used in this section--
    Buffer area is a neutral area that surrounds the perimeter of the
race area within the regulated area described by this section. The
purpose of a buffer area is to minimize potential collision conflicts
with marine event participants or high-speed powerboats and spectator
vessels or nearby transiting vessels. This area provides separation
between a race area and a specified spectator area or other vessels
that are operating in the vicinity of the regulated area established by
the special local regulations in this section.
    Captain of the Port (COTP) Maryland-National Capital Region means
the Commander, U.S. Coast Guard Sector Maryland-National Capital Region
or any Coast Guard commissioned, warrant or petty officer who has been
authorized by the COTP to act on his behalf.
    Event Patrol Commander or Event PATCOM means a commissioned,
warrant, or petty officer of the U.S. Coast Guard who has been
designated by the Commander, Coast Guard Sector Maryland-National
Capital Region.
    Official patrol means any vessel assigned or approved by Commander,
Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    Participant means all persons and vessels registered with the event
sponsor as participating in the ``Southern Maryland Boat Club Piney
Point Rumble on the River Regatta'' event, or otherwise designated by
the event sponsor as having a function tied to the event.
    Race area is an area described by a line bound by coordinates
provided in latitude and longitude that outlines the boundary of a race
area within the regulated area defined by this section.
    Spectator means a person or vessel not registered with the event
sponsor as participants or assigned as official patrols.
    Spectator area is an area described by a line bound by coordinates
provided in latitude and longitude that outlines the boundary of a
spectator area within the regulated area defined by this section.
    (c) Special local regulations. (1) The COTP Maryland-National
Capital Region or Event PATCOM may forbid and control the movement of
all vessels and persons, including event participants, in the regulated
area described in paragraph (a)(1) of this section. When hailed or
signaled by an official patrol, a vessel or person in the regulated
area shall immediately comply with the directions given by the patrol.
Failure to do so may result in the Coast Guard expelling the person or
vessel from the area, issuing a citation for failure to comply, or
both. The COTP Maryland-National Capital Region or Event PATCOM may
terminate the event, or a participant's operations at any time the COTP
Maryland-National Capital Region or Event PATCOM believes it necessary
to do so for the protection of life or property.
    (2) Except for participants and vessels already at berth, a person
or vessel within the regulated area at the start of enforcement of this
section must immediately depart the regulated area.
    (3) A spectator must contact the Event PATCOM to request permission
to either enter or pass through the regulated area. The Event PATCOM,
and official patrol vessels enforcing this regulated area, can be
contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and
channel 22A (157.1 MHz). If permission is granted, the spectator must
enter the designated spectator area or pass directly through the
regulated area as instructed by Event PATCOM. A vessel within the
regulated area must operate at safe speed that minimizes wake. A
spectator vessel must not loiter within the navigable channel while
within the regulated area.
    (4) Only participant vessels and official patrol vessels are
allowed to enter and remain within the race area.
    (5) Only participant vessels and official patrol vessels are
allowed to enter and transit directly through the buffer area, in order
to arrive at or depart from the race area.
    (6) A person or vessel that desires to transit, moor, or anchor
within the regulated area must obtain authorization from the COTP
Maryland-National Capital Region or Event PATCOM. A person or vessel
seeking such permission can contact the COTP Maryland-National Capital
Region at telephone number<PHONE_NUMBER> or on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz) or the Event PATCOM on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz).
    (7) The Coast Guard will publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue a marine information
broadcast on VHF-FM marine band radio announcing specific event dates
and times.
    (d) Enforcement officials. The Coast Guard may be assisted with
marine event patrol and enforcement of the regulated area by other
Federal, state, and local agencies.
    (e) Enforcement period. This section will be enforced from 7:30
a.m. to 5 p.m. on June 4, 2022, and from 7:30 a.m. to 5 p.m. on June 5,
2022.

    Dated: March 30, 2022.
David E. O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2022-07404 Filed 4-6-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78166-78167]
[FR Doc No: 2016-26758]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0086]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Potential Tobacco Product Violations Reporting Form

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
contained in FDA's Tobacco Product Violations Reporting Form.

DATES: Submit either electronic or written comments on the collection
of information by January 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2014-N-0086 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Potential Tobacco Product
Violations Reporting Form.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party.

Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Potential Tobacco Product Violations Reporting Form--OMB Control Number
0910-0716--Extension

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended section 201 et seq.
of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
321 et seq.) by adding a new chapter granting FDA important new
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors. FDA is requesting an extension of OMB approval
for the collection of information to accept consumer and other
stakeholder feedback and notification of potential violations of the
FD&C Act, as amended by the Tobacco Control Act.
    FDA created a Tobacco Call Center (with a toll-free number: 1-877-
CTP-1373). Callers are able to report potential violations of the
Tobacco Control Act, and FDA may conduct followup investigations based
on information received. When callers report a violation, the caller
will be asked to provide as much certain information as they can
recall, including: The date the potential violation occurred; product
type (e.g., cigarette, smokeless, roll-your-own, cigar, e-cigarette,
hookah, pipe tobacco); tobacco brand; potential violation type; type of
potentially violative promotional materials; who potentially violated;
and the name, address, phone number, and email address of the potential
violator. The caller will also be asked to list the potential
violator's Web site (if available), describe the potential violation,
and provide any additional files or information pertinent to the
potential violation.
    FDA currently provides a form that may be used to solicit this
information from the caller (Form FDA 3779, Potential Tobacco Product
Violations Report), and seeks renewal of Form FDA 3779. This form is
posted on FDA's Web site. The public and interested stakeholders are
also able to report information regarding possible violations of the
Tobacco Control Act through the following methods: Calling the Tobacco
Call Center using the Center for Tobacco Products' (CTP) toll-free
number; using a fillable Form FDA 3779 found on FDA's Web site;
downloading a PDF version of the form to send via email or mail to FDA;
requesting a copy of Form FDA 3779 by contacting CTP and sending by
mail to FDA; and sending a letter to FDA's CTP.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
         Activity and FDA form 3779              Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting violations of the FD&C Act, as                 750               2           1,500  0.25 (15 minutes).........................             375
 amended by the Tobacco Control Act via
 telephone, Internet form, mail, smartphone
 application, or email.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that submitting the information (by telephone,
Internet form, paper form by mail, or email) will take 0.25 hour (i.e.,
15 minutes) per response. Based on the type and rate of reporting that
has been submitted through the Potential Tobacco Violation Reporting
Form in the past, in addition to the increase that FDA has recently
experienced in the rate of reporting due to the recent rule, ``Deeming
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic
Act, as Amended by the Family Smoking Prevention and Tobacco Control
Act,'' FDA estimates the number of annual respondents to this
collection of information will be 750, who will each submit 2 reports
by telephone, Internet form, paper form, or email. Each report is
expected to take 0.25 hour to complete and submit; therefore, total
burden hours for this collection of information is estimated to be 375
hours (1,500 responses x 0.25 hour per response).

    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26758 Filed 11-4-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 38 (Tuesday, February 26, 2019)]
[Notices]
[Page 6140]
[FR Doc No: 2019-03261]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. IS18-766-000; IS18-767-000]

Mid-America Pipeline Company, LLC, Seminole Pipeline Company LLC;
Notice Rescheduling Technical Conference

    The technical conference that has been rescheduled for February 20,
2019, is hereby postponed due to the forecast of inclement weather.
Information regarding the new date for this conference will be
forthcoming in subsequent notice.\1\
---------------------------------------------------------------------------

    \1\ See the Notice of Technical Conference issued on December
12, 2018, for additional details regarding this conference.

    Dated: February 19, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-03261 Filed 2-25-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Proposed Rules]
[Pages 76151-76154]
[FR Doc No: 2022-26937]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1579; Project Identifier MCAI-2022-00903-T]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2021-09-12, which applies to certain Dassault Aviation Model FALCON 7X
airplanes. AD 2021-09-12 requires revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations. Since the FAA issued AD 2021-09-
12, the FAA has determined that new or more restrictive airworthiness
limitations are necessary. This proposed AD would continue to require
the actions in AD 2021-09-12 and require revising the existing
maintenance or inspection program, as applicable, to incorporate
additional new or more restrictive airworthiness limitations, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference (IBR). The FAA is proposing
this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by January 27,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1579; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For material that is proposed for IBR in this NPRM,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu. It is
also available at regulations.gov under Docket No. FAA-2022-1579.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send

your comments to an address listed under ADDRESSES. Include ``Docket
No. FAA-2022-1579; Project Identifier MCAI-2022-00903-T'' at the
beginning of your comments. The most helpful comments reference a
specific portion of the proposal, explain the reason for any
recommended change, and include supporting data. The FAA will consider
all comments received by the closing date and may amend this proposal
because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

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

Background

    The FAA issued AD 2021-09-12, Amendment 39-21526 (86 FR 23593, May
4, 2021) (AD 2021-09-12), for certain Dassault Aviation Model FALCON 7X
airplanes. AD 2021-09-12 was prompted by MCAI originated by EASA, which
is the Technical Agent for the Member States of the European Union.
EASA issued AD 2020-0214, dated October 6, 2020 (EASA AD 2020-0214)
(which corresponds to FAA AD 2021-09-12), to correct an unsafe
condition.
    AD 2021-09-12 requires revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations. The FAA issued AD 2021-09-12 to
address reduced structural integrity and reduced control of airplanes
due to the failure of system components. AD 2021-09-12 specifies that
accomplishing the revision required by that AD terminates certain
requirements of AD 2014-16-23, Amendment 39-17947 (79 FR 52545,
September 4, 2014) (AD 2014-16-23).

Actions Since AD 2021-09-12 Was Issued

    Since the FAA issued AD 2021-09-12, EASA superseded EASA AD 2020-
0214 and issued EASA AD 2022-0142, dated July 7, 2022 (EASA AD 2022-
0142) (referred to after this as the MCAI), for all Dassault Aviation
Model FALCON 7X airplanes. The MCAI states that new or more restrictive
airworthiness limitations have been issued.
    Airplanes with an original airworthiness certificate or original
export certificate of airworthiness issued after June 7, 2021 must
comply with the airworthiness limitations specified as part of the
approved type design and referenced on the type certificate data sheet;
this proposed AD therefore does not include those airplanes in the
applicability.
    The FAA is proposing this AD to address reduced structural
integrity and reduced control of airplanes due to the failure of system
components. You may examine the MCAI in the AD docket at
regulations.gov under Docket No. FAA-2022-1579.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2022-0142. This service information
specifies new or more restrictive airworthiness limitations for
airplane structures and safe life limits.
    This proposed AD would also require EASA AD 2020-0214, dated
October 6, 2020, which the Director of the Federal Register approved
for incorporation by reference as of June 8, 2021 (86 FR 23593, May 4,
2021).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in ADDRESSES.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
described above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would retain certain requirements of AD 2021-09-
12. This proposed AD would also require revising the existing
maintenance or inspection program, as applicable, to incorporate
additional new or more restrictive airworthiness limitations, which are
specified in EASA AD 2022-0142 already described, as proposed for
incorporation by reference. Any differences with EASA AD 2022-0142 are
identified as exceptions in the regulatory text of this AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections) and
Critical Design Configuration Control Limitations (CDCCLs). Compliance
with these actions and CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance (AMOC) according to
paragraph (n)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to retain the IBR of EASA AD 2020-0214 and incorporate
EASA AD 2022-0142 by reference in the FAA final rule. This proposed AD
would, therefore, require compliance with EASA AD 2022-0142 and EASA AD
2020-0214 through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in

EASA AD 2022-0142 or EASA AD 2020-0214 does not mean that operators
need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2022-
0142 or EASA AD 2020-0214. Service information required by EASA AD
2022-0142 and EASA AD 2020-0214 for compliance will be available at
regulations.gov by searching for and locating Docket No. FAA-2022-1579
after the FAA final rule is published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections), intervals, or CDCCLs may be used unless the actions,
intervals, and CDCCLs are approved as an AMOC in accordance with the
procedures specified in the AMOCs paragraph under ``Additional AD
Provisions.'' This new format includes a ``New Provisions for
Alternative Actions, Intervals, and CDCCLs'' paragraph that does not
specifically refer to AMOCs, but operators may still request an AMOC to
use an alternative action, interval, or CDCCL.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 122 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2021-09-12 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2021-09-12, Amendment 39-21526
(86 FR 23593, May 4, 2021); and
0
b. Adding the following new AD:

Dassault Aviation: Docket No. FAA-2022-1579; Project Identifier
MCAI-2022-00903-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 27, 2023.

(b) Affected ADs

    (1) This AD replaces AD 2021-09-12, Amendment 39-21526 (86 FR
23593, May 4, 2021) (AD 2021-09-12).
    (2) This AD affects AD 2014-16-23, Amendment 39-17947 (79 FR
52545, September 4, 2014) (AD 2014-16-23).

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 7X airplanes,
certificated in any category, with an original airworthiness
certificate or original export certificate of airworthiness issued
on or before June 7, 2021.
    Note 1 to paragraph (c): Model FALCON 7X airplanes with
modification M1000 incorporated are commonly referred to as ``Model
FALCON 8X'' airplanes as a marketing designation.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address reduced structural integrity and reduced
control of airplanes due to the failure of system components.

(f) Compliance

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

(g) Retained Revision of the Existing Maintenance or Inspection
Program, With No Changes

    This paragraph restates the requirements of paragraph (j) of AD
2021-09-12, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 1, 2020, except as specified
in paragraph (h) of this AD: Comply with all required actions and
compliance times specified in, and in accordance with, European
Union Aviation Safety Agency (EASA) AD 2020-0214, dated October 6,
2020 (EASA AD 2020-0214). Accomplishing the revision of the existing
maintenance or inspection program required by paragraph (j) of this
AD terminates the requirements of this paragraph.

(h) Retained Exceptions to EASA AD 2020-0214, With No Changes

    This paragraph restates the exceptions specified in paragraph
(k) of AD 2021-09-12, With no changes.
    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2020-0214 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2020-0214 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, to incorporate the ``limitations, tasks and
associated thresholds and intervals'' specified in paragraph (3) of
EASA AD 2020-0214 within 90 days after June 8, 2021 (the effective
date of this AD 2021-09-12).
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2020-0214 is at the applicable ``associated
thresholds'' specified in paragraph (3) of EASA AD 2020-0214, or
within 90 days after June 8, 2021 (the effective date of this AD
2021-09-12), whichever occurs later.
    (4) The provisions specified in paragraphs (4) and (5) of EASA
AD 2019-0257 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2020-0214 does not apply
to this AD.

(i) Retained Restrictions on Alternative Actions, Intervals, and
Critical Design Configuration Control Limitations (CDCCLs), With a New
Exception

    This paragraph restates the requirements of paragraph (l) of AD
2021-09-12, with a new exception. Except as required by paragraph
(j) of this AD, after the maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections), intervals, or CDCCLs are allowed unless
they are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2020-0214.

(j) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (k) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2022-0142, dated July 7, 2022 (EASA AD
2022-0142). Accomplishing the revision of the existing maintenance
or inspection program required by this paragraph terminates the
requirements of paragraph (g) of this AD.

(k) Exceptions to EASA AD 2022-0142

    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2022-0142 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2022-0142 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2022-0142 is at the applicable
``limitations'' and ``associated thresholds'' as incorporated by the
requirements of paragraph (3) of EASA AD 2022-0142, or within 90
days after the effective date of this AD, whichever occurs later.
    (4) The provisions specified in paragraphs (4) and (5) of EASA
AD 2022-0142 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2022-0142 does not apply
to this AD.

(l) New Provisions for Alternative Actions, Intervals, and CDCCLs

    After the existing maintenance or inspection program has been
revised as required by paragraph (j) of this AD, no alternative
actions (e.g., inspections), intervals, and CDCCLs are allowed
unless they are approved as specified in the provisions of the
``Ref. Publications'' section of EASA AD 2022-0142.

(m) Terminating Action for Certain Requirements in AD 2014-16-23

    Accomplishing the actions required by paragraphs (g) or (j) of
this AD terminates the requirements of paragraph (q) of AD 2014-16-
23.

(n) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (o) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(o) Additional Information

    For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email [email protected].

(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
[DATE 35 DAYS AFTER PUBLICATION OF THE FINAL RULE].
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0142,
dated July 7, 2022.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
June 8, 2021 (86 FR 23593, May 4, 2021).
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0214,
dated October 6, 2020.
    (ii) [Reserved]
    (5) For EASA ADs 2022-0142 and 2020-0214, contact EASA, Konrad-
Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000;
email [email protected]; website easa.europa.eu. You may find these
EASA ADs on the EASA website at ad.easa.europa.eu.
    (6) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (7) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 6, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-26937 Filed 12-12-22; 8:45 am]
BILLING CODE 4910-13-P


11(b). An adviser may currently conduct certain due diligence and
monitoring of these types of third-party recordkeepers as part of the
adviser's efforts to ensure its compliance with its existing
recordkeeping obligations. However, these practices may not meet all
the specific requirements of the proposal as rule 204-2 does not
currently prescribe specific due diligence and monitoring requirements
nor does the existing rule framework provide a comprehensive oversight
of such service providers. Additionally, under rule 204-2(f), an
investment adviser, before discontinuing its investment advisory
business or otherwise terminating its advisory activities, is required
to arrange and be responsible for the preservation of books and records
required by the rule for the remainder of the required retention
period. While an adviser may currently seek to coordinate with a third-
party recordkeeper to ensure records required under the recordkeeping
rule will be preserved for the required retention period, that adviser
may not have obtained reasonable assurance that the third party will
make arrangements to ensure the continued availability of records
should the third party cease its business operations. Proposed rule
204-2(l) is intended to complement existing rule 204-2(f) and ensure
the continued availability of the records in the event that a third-
party recordkeeper ceases operations or the relationship with the
adviser is terminated.
    The amendments to rule 204-2 are complementary to the existing
recordkeeping framework because the changes would conform rule 204-2 to
the proposed service provider oversight rule and provide express
requirements for when an adviser outsources recordkeeping functions.
There are no duplicative, overlapping, or conflicting Federal rules
with respect to the proposed amendments to rule 204-2.
3. Proposed Amendments to Form ADV
    Our proposed new Item 7.C in Form ADV Part 1A would require SEC-
registered advisers to: (1) indicate whether they outsource any covered
functions to a service provider; (2) disclose information of each such
service provider including legal and primary business names of the
service provider, legal entity identifier, and address of service
provider; (3) indicate whether identified service provider is a related
person of the adviser; (4) date the service provider was first engaged,
and (5) the covered function(s) that the service provider is engaged to
perform. Currently, Item 7 in Form ADV Part 1A requires an adviser to
disclose information about financial industry affiliations and
activities, and to state whether the adviser advises any private funds,
and if so, provide certain information related to those private funds.
The proposed requirements would not be duplicative of, overlap, or
conflict with, other information advisers are required to provide on
Form ADV.

F. Significant Alternatives

    The Regulatory Flexibility Act (``RFA'') directs the Commission to
consider significant alternatives that would accomplish our stated
objective, while minimizing any significant economic effect on small
entities.\316\ We considered the following alternatives for small
entities in relation to our proposal: (1) exempting advisers that are
small entities from the proposed due diligence and monitoring
requirements under proposed rule 206(4)-11 and related provisions under
the proposed amendments to rule 204-2, to account for resources
available to small entities; (2) establishing different requirements or
frequency, to account for resources available to small entities; (3)
clarifying, consolidating, or simplifying the compliance requirements
under the proposal for small entities; and (4) using design rather than
performance standards.
---------------------------------------------------------------------------

    \316\ See 5 U.S.C. 603(c).
---------------------------------------------------------------------------

1. Proposed Rules 206(4)-11 and 204-2
    The RFA directs the Commission to consider significant alternatives
that would accomplish our stated objectives, while minimizing any
significant adverse effect on small entities. We considered the
following alternatives for small entities in relation to the proposed
rules 206(4)-11 and 204-2: (1) differing compliance or reporting
requirements that take into account the resources available to small
entities; (2) the clarification, consolidation, or simplification of
compliance and reporting requirements under the proposed rule for such
small entities; (3) the use of design rather than performance
standards; and (4) an exemption from coverage of the proposed rule, or
any part thereof, for such small entities.
    Regarding the first and fourth alternatives, the Commission
believes that establishing different compliance or reporting
requirements for small advisers, or exempting small advisers from the
proposed rule, or any part thereof, would be inappropriate under these
circumstances. Because the protections of the Advisers Act are intended
to apply equally to clients of both large and small firms, it would be
inconsistent with the purposes of the Advisers Act to specify
differences for small entities under the proposed rule 206(4)-11 and
corresponding changes to rule 204-2. We believe that the proposed rule
would result in multiple benefits to clients.\317\ For example, having
appropriate due diligence and monitoring measures in place would help
address any potential risks and incidents that occur at the service
provider and help protect advisers and their clients from greater risk
of harm. We believe that these benefits should apply to clients of
smaller firms as well as larger firms. Establishing different
conditions for large and small advisers even though advisers of every
type and size rely on various service providers for performing covered
functions and thus face increasing compliance gap and other risks would
negate these benefits. The corresponding changes to rule 204-2 are
tailored to address proposed rule 206(4)-11 and the requirements for
outsourcing recordkeeping functions.
---------------------------------------------------------------------------

    \317\ See supra section III.D.
---------------------------------------------------------------------------

    Regarding the second alternative, we believe the current proposal
is clear and that further clarification, consolidation, or
simplification of the compliance requirements is not necessary. The
proposed rule would require advisers to:

(1) conduct certain due diligence before engaging a service provider to
perform a covered function; and (2) periodically monitor the service
provider's performance of the covered function and reassess the
retention of the service provider in accordance with the due diligence
requirements.\318\ The proposed rule would provide a minimum,
consistent oversight framework regarding an adviser outsourcing
functions or services that are necessary to provide advisory services
in compliance with the Federal securities laws, and that if not
performed or if performed negligently would be reasonably likely to
cause a material negative impact on an adviser's clients or an
adviser's ability to perform its services. The proposed rule would
serve as an explicit requirement for advisers to oversee service
providers covered by the rule appropriately and is designed to address
our concern that outsourcing covered functions in particular, without
further action by the investment adviser, can undermine the adviser's
provision of services, and can otherwise harm clients.
---------------------------------------------------------------------------

    \318\ See proposed rule 206(4)-11. See also supra section II.B
and C.
---------------------------------------------------------------------------

    Regarding the third alternative, we determined to use performance
standards rather than design standards. Although the proposed rule
requires due diligence and monitoring that are reasonably designed to
address a certain number of elements, we do not place certain
conditions or restrictions on how to adopt and implement such
requirements. The general elements are designed to enumerate core areas
that firms must address when conducting due diligence and monitoring of
a service provider. Given the number and varying characteristics of
advisers, we believe firms need the ability to tailor their measure or
method in conducting due diligence and monitoring based on their
individual facts and circumstances.\319\ Similarly, rather than
requiring a written agreement with specific language provisions, the
proposed rule would afford advisers the flexibility to customize and
tailor their processes to the proposed requirements.\320\ Proposed rule
206(4)-11 therefore allows advisers to address the general elements
based on the particular risks posed by each adviser's operations and
business practices as well as the types of covered functions that are
outsourced and the types of service providers engaged. The proposed
rule would also provide flexibility for the adviser to determine the
personnel who would implement and oversee the effectiveness of its due
diligence and monitoring.
---------------------------------------------------------------------------

    \319\ See supra section II.B and C.
    \320\ See proposed rule 206(4)-11(a).
---------------------------------------------------------------------------

2. Proposed Amendments to Form ADV
    The RFA directs the Commission to consider significant alternatives
that would accomplish our stated objectives, while minimizing any
significant adverse effect on small entities. We considered the
following alternatives for small entities in relation to the proposed
amendments to Form ADV: (1) differing compliance or reporting
requirements that take into account the resources available to small
entities; (2) the clarification, consolidation, or simplification of
compliance and reporting requirements under the proposed amendments for
such small entities; (3) the use of design rather than performance
standards; and (4) an exemption from coverage of the proposed
amendments, or any part thereof, for such small entities.
    Regarding the first and fourth alternatives, the Commission
believes that establishing different compliance or reporting
requirements for small advisers, or exempting small advisers from the
proposed amendments, or any part thereof, would be inappropriate under
these circumstances. Because the protections of the Advisers Act are
intended to apply equally to clients of both large and small firms, it
would be inconsistent with the purposes of the Advisers Act to specify
differences for small entities under the proposed amendments to Form
ADV. We believe that the proposed amendments would result in multiple
benefits to clients.\321\ For example, the proposed amendments to Form
ADV would improve the ability of clients and prospective clients to
evaluate and conduct a more comprehensive due diligence of an adviser,
addressing any potential concerns related to an adviser's use of a
particular service provider. We believe that these benefits should
apply to clients of smaller firms as well as larger firms. Establishing
different conditions for large and small advisers even though all
advisers, regardless of type and size, engage service providers to
outsource certain covered functions, would negate these benefits.
---------------------------------------------------------------------------

    \321\ See supra section III.D.
---------------------------------------------------------------------------

    Regarding the second alternative, we believe the current proposed
amendments are clear and that further clarification, consolidation, or
simplification of the compliance requirements is not necessary. The
proposed amendments to Form ADV would require advisers to disclose
information regarding the service providers that perform covered
functions.\322\ The proposed amendments to Form ADV would provide for
advisers to present clear and meaningful disclosure regarding such
service providers to their clients and prospective clients.
---------------------------------------------------------------------------

    \322\ See supra section II.D.
---------------------------------------------------------------------------

    Regarding the third alternative, we determined that for the
Commission and its staff to better identify and address risks related
to outsourcing by advisers and oversee advisers' use of service
providers and to enable clients to make better informed decisions about
the retention of an adviser, advisers must provide certain baseline
information about their service providers. The proposed amendments to
Form ADV do not contain any specific limitations or restrictions on the
disclosure of service providers. Given the number and varying types of
advisers, as well as the types of covered functions and service
providers that may be engaged at a particular adviser, respectively, we
believe firms need the ability to tailor their disclosures according to
their own circumstances.\323\
---------------------------------------------------------------------------

    \323\ See supra section II.B.
---------------------------------------------------------------------------

G. Solicitation of Comments

    We encourage written comments on the matters discussed in this
IRFA. We solicit comment on the number of small entities subject to the
proposed rule 206(4)-11 and proposed amendments to rule 204-2 and Form
ADV. We also solicit comment on the potential effects discussed in this
analysis; and whether this proposal could have an effect on small
entities that has not been considered. We request that commenters
describe the nature of any effect on small entities and provide
empirical data to support the extent of such effect.

VI. Consideration of Impact on the Economy

    For purposes of the Small Business Regulatory Enforcement Fairness
Act of 1996, or ``SBREFA,'' \324\ we must advise OMB whether a proposed
regulation constitutes a ``major'' rule. Under SBREFA, a rule is
considered ``major'' where, if adopted, it results in or is likely to
result in (1) an annual effect on the economy of $100 million or more;
(2) a major increase in costs or prices for consumers or individual
industries; or (3) significant adverse effects on competition,
investment or innovation. We request comment on whether the proposal
would be a ``major rule'' for purposes of SBREFA. We request comment on
the potential effect of the

proposed amendments on the U.S. economy on an annual basis; any
potential increase in costs or prices for consumers or individual
industries; and any potential effect on competition, investment or
innovation. Commenters are requested to provide empirical data and
other factual support for their views to the extent possible.
---------------------------------------------------------------------------

    \324\ Public Law 104-121, Title II, 110 Stat. 857 (1996)
(codified in various sections of 5 U.S.C., 15 U.S.C., and as a note
to 5 U.S.C. 601).
---------------------------------------------------------------------------

VII. Statutory Authority

    The Commission is proposing rule 206(4)-11 under the Advisers Act
under the authority set forth in sections 203(d), 206(4), and 211(a)
and (h) of the Advisers Act of 1940 [15 U.S.C. 80b-3(d), 10b-6(4) and
80b-11(a) and (h)]. The Commission is proposing amendments to rule 204-
2 under the Advisers Act under the authority set forth in sections 204
and 211 of the Advisers Act of 1940 [15 U.S.C. 80b-4 and 80b-11]. The
Commission is proposing amendments to Form ADV under section 19(a) of
the Securities Act [15 U.S.C. 77s(a)], sections 23(a) and 28(e)(2) of
the Exchange Act [15 U.S.C. 78w(a) and 78bb(e)(2)], section 319(a) of
the Trust Indenture Act of 1939 [15 U.S.C. 7sss(a)], section 38(a) of
the Investment Company Act [15 U.S.C. 80a-37(a)], and sections
203(c)(1), 204, and 211(a) and (h) of the Advisers Act of 1940 [15
U.S.C. 80b-3(c)(1), 80b-4, and 80b-11(a) and (h)].

List of Subjects in 17 CFR Parts 275 and 279

    Reporting and recordkeeping requirements, Securities.

Text of Proposed Rule and Form Amendments

    For the reasons set out in the preamble, title 17, chapter II of
the Code of Federal Regulations is proposed to be amended as follows:

PART 275--RULES AND REGULATIONS, INVESTMENT ADVISERS ACT OF 1940

0
1. The authority citation for part 275 continues to read, in part, as
follows:

    Authority: 15 U.S.C. 80b-2(a)(11)(G), 80b-2(a)(11)(H), 80b-
2(a)(17), 80b-3, 80b-4, 80b-4a, 80b-6(4), 80b-6a, and 80b-11, unless
otherwise noted.
* * * * *
    Section 275.204-2 is also issued under 15 U.S.C. 80b-6.
* * * * *
    Amend Sec.  275.204-2 by adding reserved paragraphs (a)(20) through
(23) and paragraphs (a)(24), (e)(4), and (l) to read as follows:

Sec.  275.204-2  Books and records to be maintained by investment
advisers.

    (a) * * *
    (20)-(23) [Reserved]
    (24)(i) A list or other record of Covered Functions that the
adviser has outsourced to a Service Provider, as defined in Sec.
275.206(4)-11, including the name of each Service Provider, along with
a record of the factors, corresponding to each listed function, that
led the adviser to list it as a Covered Function;
    (ii) Records documenting the due diligence assessment conducted
pursuant to Sec.  275.206(4)-11, including any policies and procedures
or other documentation as to how the adviser will comply with Sec.
275.206(4)-11(a)(1)(ii);
    (iii) A copy of any written agreement, including any amendments,
appendices, exhibits, and attachments, entered into with a Service
Provider regarding Covered Functions, each as defined in Sec.
275.206(4)-11; and
    (iv) Records documenting the periodic monitoring of a Service
Provider pursuant to Sec.  275.206(4)-11.
* * * * *
    (e) * * *
    (4) Books and records required to be made under paragraph (a)(24)
of this rule shall be maintained in an easily accessible place
throughout the time period during which the adviser has outsourced a
Covered Function to a Service Provider and for a period of five years
thereafter.
* * * * *
    (l) Every investment adviser subject to paragraph (a) of this
section that relies on a third party to make and/or keep any books and
records required by this section (the recordkeeping function) must:
    (1) Due diligence and monitoring. Perform due diligence and
monitoring as prescribed in Sec.  275.206(4)-11(a)(1) and (a)(2) with
respect to the recordkeeping function, and make and keep such records
as prescribed in paragraph (a)(24) of this section, in each case as
though the recordkeeping function were a Covered Function as defined in
Sec.  275.206(4)-11(b) and the third party were a Service Provider as
defined in Sec.  275.206(4)-11(b); and
    (2) Obtain reasonable assurances that the third party will:
    (i) Adopt and implement internal processes and/or systems for
making and/or keeping records on behalf of the investment adviser that
meet all of the requirements of this section as applicable to the
investment adviser;
    (ii) Make and/or keep records of the investment adviser that meet
all of the requirements of this section as applicable to the investment
adviser;
    (iii) For electronic records of the investment adviser that are
made and/or kept by the third party under this subparagraph, allow the
investment adviser and staff of the Commission to access the records
easily through computers or systems during the required retention
period pursuant to this section; and
    (iv) Make arrangements to ensure the continued availability of
records of the investment adviser that are made and/or kept under this
subparagraph by the third party that will meet all of the requirements
of this section as applicable to the investment adviser in the event
that the third party ceases operations or the relationship with the
investment adviser is terminated.
0
3. Section 275.206(4)-11 is added to read as follows:

Sec.  275.206(4)-11  Service Providers.

    (a) As a means reasonably designed to prevent fraudulent,
deceptive, or manipulative acts, practices, or courses of business
within the meaning of section 206(4) of the Act (15 U.S.C. 80b-6(4)),
it shall be unlawful for an investment adviser registered or required
to be registered under section 203 of the Act (15 U.S.C. 80b-3) to
retain a Service Provider to perform a Covered Function unless:
    (1) Due diligence. Before engaging such Service Provider, the
adviser reasonably identifies, and determines that it would be
appropriate to outsource the Covered Function and that it would be
appropriate to select that Service Provider, by:
    (i) Identifying the nature and scope of the Covered Function the
Service Provider is to perform;
    (ii) Identifying, and determining how it will mitigate and manage,
the potential risks to clients or to the adviser's ability to perform
its advisory services resulting from engaging a Service Provider to
perform the Covered Function and engaging that Service Provider to
perform the Covered Function;
    (iii) Determining that the Service Provider has the competence,
capacity, and resources necessary to perform the Covered Function in a
timely and effective manner;
    (iv) Determining whether the Service Provider has any
subcontracting arrangements that would be material to the Service
Provider's performance of the Covered Function, and identifying and
determining how the investment adviser will mitigate and manage
potential risks to clients or to the investment adviser's ability to
perform its advisory services in light of any such subcontracting
arrangement;
    (v) Obtaining reasonable assurance from the Service Provider that
it is able

to, and will, coordinate with the investment adviser for purposes of
the adviser's compliance with the Federal securities laws, as
applicable to the Covered Function; and
    (vi) Obtaining reasonable assurance from the Service Provider that
it is able to, and will, provide a process for orderly termination of
its performance of the Covered Function.
    (2) Monitoring. The adviser periodically monitors the Service
Provider's performance of the Covered Function and reassesses the
retention of the Service Provider in accordance with the due diligence
requirements of paragraph (a)(1) of this section and with a manner and
frequency such that the investment adviser reasonably determines that
it is appropriate to continue to outsource the Covered Function and
that it remains appropriate to outsource it to the Service Provider.
    (b) Definitions. For the purposes of this section:
    Covered Function means a function or service that is necessary for
the investment adviser to provide its investment advisory services in
compliance with the Federal securities laws, and that, if not performed
or performed negligently, would be reasonably likely to cause a
material negative impact on the adviser's clients or on the adviser's
ability to provide investment advisory services. A covered function
does not include clerical, ministerial, utility, or general office
functions or services.
    Service Provider means a person or entity that:
    (i) Performs one or more Covered Functions; and
    (ii) Is not a supervised person, as defined in 15 U.S.C. 80b-
2(a)(25), of the investment adviser.

PART 279--FORMS PRESCRIBED UNDER THE INVESTMENT ADVISERS ACT OF
1940

0
4. The authority citation for part 279 continues to read as follows:

    Authority: The Investment Advisers Act of 1940, 15 U.S.C. 80b-1
et seq., Pub. L. 111-203, 124 Stat. 1376.

0
5. Amend Form ADV (referenced in Sec.  279.1) by:
0
a. In General Instructions, revising the second sub-bullet point
paragraph to the first bullet point paragraph under Instruction 3;
0
b. In Instructions for Part 1A, revising the heading and introductory
text of 6. Item 7;''
0
c. In Glossary of Terms, redesignating items 11 through 53 as 12
through 54, and items 55 through 65 as 57 through 67;
0
d. In Glossary of Terms, adding new items 11 and 57;
0
e. In Part 1A, revising Item 7 heading and introductory text, and
adding C; and
0
f. In Schedule D, adding Section 7.C.
    The additions and revisions read as follows:

    Note: The text of Form ADV does not, and this amendment will
not, appear in the Code of Federal Regulations.

BILLING CODE 8011-01-P

[GRAPHIC] [TIFF OMITTED] TP16NO22.000

[GRAPHIC] [TIFF OMITTED] TP16NO22.001

[GRAPHIC] [TIFF OMITTED] TP16NO22.002

[GRAPHIC] [TIFF OMITTED] TP16NO22.003

    By the Commission.

    Dated: October 26, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-23694 Filed 11-15-22; 8:45 am]
BILLING CODE 8011-01-C


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Kerry Leifer, Branch Chief Inert Assessment Branch (IAB)<PHONE_NUMBER>.

 INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.  TEMPLATE:

Spring Regulatory Sciences on behalf of BASF Corporation. IN-11530

 EPA has received a pesticide petition (IN-11530) from Spring Regulatory Sciences on behalf of BASF Corporation, 100 Park Avenue, Florham Park, New Jersey 07932 (EPA Co. No 33753) proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to amend the exemption from the requirement of a tolerance for for α-alkyl (minimum C6 linear or branched, saturated and or unsaturated)-ω-hydroxypolyoxyethylene polymer with or without polyoxypropylene, mixture of di- and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium and zinc salts of the phosphate esters; minimum oxyethylene content averages 2 moles; minimum oxypropylene content is 0 moles and α-alkyl(C6-C15)-ω-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2-4 moles in or on the raw agricultural commodity growing crops under 40 CFR 180.910 and 930. For ease of reading, the alkyl alcohol alkoxylate phosphate and sulfate derivatives are referred to throughout this document as AAAPDs and AAASDs respectively, and collectively as AAAPSDs.

 This petition proposes the addition of CAS number 157627-92-4, Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts.    EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

 Residue Chemistry

EPA has evaluated the available toxicity data and considered its 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.

 Analytical method. 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.

 Magnitude of residues. BASF Corporation is petitioning the agency to amend an existing exemption from the requirement of a tolerance. Therefore, information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required.

    Toxicological Profile

 Acute toxicity. The AAASD and AAAPD surfactants are not acutely toxic by the oral and dermal routes of exposure under normal use conditions. Concentrated materials are generally moderate to severe eye and skin irritants and may be skin sensitizers.

 Genotoxicty. There is no evidence of mutagenicity in the mouse lymphoma L5178 TK +/- gene mutation study.

 Reproductive	and	developmental	toxicity.	In a rat developmental toxicity study conducted with the AAASD surfactant, no maternal or developmental toxicity was observed at 700 mg/kg/day. In an OECD 416 reproduction and fertility effects study conducted with the AAASD surfactant, the only significant effects observed were liver effects characterized by dose-related decrease in absolute and relative liver weight and an increased incidence in the number of animals with "minimal" hepatocyte necrosis in males. There were no treatment-related effects on reproductive parameters or the offspring.    In an OECD 422 study conducted with the AAAPD surfactant CAS RN 78330-24-2, parental toxicity was observed based on lesions in the forestomach and thymus atrophy in females. Developmental toxicity observed was based on increased number of stillborn pups and pups dying and clinical observations (coldness to the touch, discolored heads, and a lack of nesting behavior); however, reproductive toxicity was not observed.    In the second OECD 422 study conducted with the AAAPD surfactant CAS RN 68130-47-2, parental toxicity was observed based on clinical signs (rales and excessive salivation), reduced body weight, and lesions in the forestomach. Reproductive, developmental, and offspring toxicity were not observed at any dose level.     In general, surfactants are surface-active materials that can damage the structural integrity of cellular membranes at high dose levels. Thus, surfactants are often corrosive and irritating in concentrated solutions. It is possible that some of the observed toxicity seen in the repeated studies, such as irritation of forestomach or decreased body weight gain, can be attributed to the corrosive and irritating nature of these surfactants.          Subchronic toxicity. Following subchronic exposure to rats, gastrointestinal irritation (increased incidences of hyperplasia, submucosal edema, and ulceration) was observed, but no specific target organ toxicity or neurotoxicity was seen. No effects were detected in a functional observational battery (FOB) or motor activity assessment.

 Chronic toxicity. In an OECD 416 reproduction and fertility effects study conducted with the AAASD surfactant, the only significant effects observed were liver effects characterized by dose-related decrease in absolute and relative liver weight and an increased incidence in the number of animals with "minimal" hepatocyte necrosis in males. There were no treatment-related effects on reproductive parameters or the offspring.          Endocrine disruption. EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following recommendations of its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).    When additional appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, the AAAPD and AAASD surfactants may be subjected to further screening and/or testing to better characterize effects related to endocrine disruption.       Aggregate Exposure

 Dietary exposure. In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

 i. Food. In conducting the acute and chronic dietary exposure assessments, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data was submitted for AAAPSDs.  In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredients. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides.    ii. Drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for AAAPSDs, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessment. These values were directly entered into the dietary exposure model.    2. Non-dietary exposure. The term "residential exposure" is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). AAAPSDs are used as inert ingredients in pesticide products that are registered for specific uses that could result in indoor residential exposures and may have uses as inert ingredients in pesticide products that may result in outdoor residential exposures.    A screening level residential exposure and risk assessment was completed for products containing AAAPSDs as inert ingredients. In this assessment, representative scenarios, based on end-use product application methods and labeled application rates, were selected. For each of the use scenarios, the Agency assessed residential handler (applicator) inhalation and dermal exposure for use scenarios with high exposure potential (i.e., exposure scenarios with high-end unit exposure values) to serve as a screening assessment for all potential residential pesticides containing AAAPSDs. Similarly, residential postapplication dermal and oral exposure assessments were also performed utilizing high-end exposure scenarios.       Cumulative Effects

BASF Corporation has not found a common mechanism of toxicity finding and the AAAPSDs not appear to produce a toxic metabolite produced by other substances. For the purposes of this requested tolerance action the AAAPSDs do not have a common mechanism of toxicity with other substances.

    Safety Determination

 U.S. population. Based on these risk assessments, BASF Corporation 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 AAAPSDs.

 Infants and children. Based on these risk assessments, BASF Corporation 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 AAAPSDs.

    International Tolerances

BASF Corporation is not aware of any country requiring a tolerance for the AAAPSDs nor have any CODEX Maximum Residue Levels been established for any food crops at this time.