[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6498-6500]
[FR Doc No: 2017-01230]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0268; FRL-9958-50-OW]

Revision to the PAG Manual: Protective Action Guide (PAG) for
Drinking Water After a Radiological Incident

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: As part of its mission to protect human health and the
environment, the Environmental Protection Agency publishes protective
action guides (PAGs) to help federal, state, local and tribal emergency
response officials make radiation protection decisions during
emergencies. EPA, in coordination with a multi-agency working group
within the Federal Radiological Preparedness Coordinating Committee,
recently updated its guidance manual on this topic, titled ``Protective
Action Guides and Planning Guidance for Radiological Incidents''
(referred to herein as the PAG Manual). On December 8, 2016, EPA
announced availability of the updated 2016 PAG Manual in the Federal
Register. In this document, EPA is announcing that it has amended
Chapter 4 of the 2016 PAG Manual to incorporate guidance for radiation
protection decisions concerning drinking water. The drinking water PAG
is not binding and does not in any way affect regulatory requirements
or enforcement of the Safe Drinking Water Act (SDWA), including maximum
contaminant limits (MCLs) for radionuclides established by regulation
under the SDWA. The drinking water PAG is guidance only and is intended
for use by federal, state and local emergency management officials in
the unlikely event of significant radiological contamination incidents,
such as a disaster at a nuclear power plant, a radiological dispersal
device or an improvised nuclear device, and for a duration which may
last for weeks to months but not longer than one year. The dose levels
reflected in the drinking water PAG provide a level of protection
against cancer risks for a short-term (weeks to months but not longer
than a year), similar to that provided by EPA's MCLs for radionuclides
(which are calculated based on 70 years of exposure). The revised
drinking water PAG is available for use upon publication of this
document in the Federal Register, at www.regulations.gov, under ID No.
EPA-HQ-OAR-2007-0268.

FOR FURTHER INFORMATION CONTACT: Samuel Hernandez, Standards and Risk
Management Division, Office of Ground Water and Drinking Water, Mail
Code 4607M, U.S. Environmental Protection Agency, 1200 Pennsylvania
Avenue NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. How can I get copies of the PAG Manual and supporting information?

    Docket: EPA has established a docket for this action under Docket
ID No. EPA-HQ-OAR-2007-0268. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air and Radiation Docket in the EPA Docket Center, (EPA/DC)
EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC 20004.
The Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Docket's
Public Reading Room is<PHONE_NUMBER> and the telephone number for the
Air and Radiation Docket is<PHONE_NUMBER>. In accordance with normal
EPA docket procedures, if copies of any docket materials are requested,
a reasonable fee may be charged for photocopying.
    Electronic access: The PAG Manual in electronic form suitable for
printing, as well as related guidelines and further information, can be
found on the PAGs' Web site at http://www.epa.gov/radiation/protective-action-guides-pags.

B. What authority does EPA have to provide Protective Action Guidance?

    The historical and legal basis of EPA's role in the PAG Manual
begins with the Reorganization Plan No. 3 of 1970, in which the
Administrator of the EPA assumed all the functions of the Federal
Radiation Council (FRC), including the charge to ``. . . advise the
President with respect to radiation matters, directly or indirectly
affecting health, including guidance for all federal agencies in the
formulation of radiation standards and in the establishment and
execution of programs of cooperation with [s]tates.'' (Reorg. Plan No.
3 of 1970, section 2(a) (7), 6(a) (2); Sec.  274.h of the Atomic Energy
Act of 1954, as amended (AEA), codified at 42 U.S.C. 2021(h)).
Recognizing this role, the Federal Emergency Management Agency (FEMA)
directed EPA, in its Radiological Emergency Planning and Preparedness
Regulations, to ``establish Protective Action Guides (PAGs) for all
aspects of radiological emergency planning in coordination with
appropriate federal agencies.'' (44 CFR 351.22(a)). FEMA also tasked
EPA with preparing ``guidance for state and local governments on
implementing PAGs, including recommendations on protective actions
which can be taken to mitigate the potential radiation dose to the
population.'' (44 CFR 351.22(b)). All of this information was to ``be
presented in the Environmental Protection Agency (EPA) `Manual of
Protective Action Guides and Protective Actions for Nuclear Incidents.'
'' (44 CFR 351.22(b)).
    Additionally, section 2021(h) charged the Administrator with
performing ``such other functions as the President may assign to him
[or her] by Executive Order.'' Executive Order 12656 states that the
Administrator shall ``[d]evelop, for national security emergencies,
guidance on acceptable emergency levels of nuclear radiation. . . .''
(Executive Order No. 12656, section 1601(2)). EPA's role in PAGs
development was recognized by the National Response Framework, Nuclear/
Radiological Incident Annex of June 2008.

C. What is the PAG Manual: Protective action guides and planning
guidance for radiological incidents?

    The PAG Manual provides federal, state and local emergency
management officials with guidance for responding to radiological
emergencies. A protective action guide is the projected dose to an
individual from a release of radioactive material at which a specific
protective action to reduce or avoid that dose is recommended.
Emergency management officials use PAGs for making decisions regarding
actions to protect the public from exposure to radiation during an
emergency. Such actions include, but are not limited to, evacuation,
shelter-in-place, temporary relocation and food restrictions.
    Development of the PAGs was based on the following essential
principles, which also apply to the selection of any protective action
during an incident:

     Prevent acute effects.
     Balance protection with other important factors and ensure
that actions result in more benefit than harm.
     Reduce risk of chronic effects.
    The PAG Manual is not a legally binding regulation or standard and
does not supersede any environmental laws. This guidance does not
address or impact site cleanups occurring under other statutory
authorities such as the EPA's Superfund program, the Nuclear Regulatory
Commission's (NRC) decommissioning program, or other federal or state
cleanup programs. As indicated by the use of non-mandatory language
such as ``may,'' ``should'' and ``can,'' the PAG Manual only provides
recommendations and does not confer any legal rights or impose any
legally binding requirements upon any member of the public, states or
any other federal agency. Rather, the PAG Manual recommends projected
radiation doses at which specific actions may be warranted in order to
reduce or avoid that dose. The PAG Manual is designed to provide
flexibility to be more or less restrictive as deemed appropriate by
decision makers based on the unique characteristics of the incident and
the local situation.

D. How did EPA respond to public comments on the proposed Draft
Protective Action Guide for Drinking Water?

    PAGs do not represent ``acceptable'' routine exposure in the way
that regulatory standards such as maximum contaminant levels do. PAGs
are guidance levels to support emergency decision making by response
authorities to avoid unnecessary radiation exposure. Development and
implementation of PAGs is always guided by three basic principles:
Prevent acute effects, balance protection with other important factors
and ensure that actions result in more benefit than harm, and reduce
risk of chronic effects.
    On June 10, 2016, EPA published a Federal Register document
requesting public comments on the proposed drinking water PAG and the
guidance for advance planning (81 FR 37589). EPA sought specific
comments and feedback on the appropriateness of the drinking water PAG
and possible implementation challenges associated with the two-tiered
approach. In addition, EPA asked whether a single-tier drinking water
PAG should be considered rather than using the tiered approach.
    In response, EPA received over 60,000 comment letters from members
of the public, state and local emergency response and health
organizations, environmental advocates, industry associations and other
stakeholders. Most of the comment letters expressed concerns with the
proposed guidance. Commenters wrote that the proposed guidance could
weaken the regulatory requirements of the Safe Drinking Water Act. In
addition, environmental advocacy organizations indicated that the
drinking water PAG dose levels were too high and insufficient to be
protective of human health, and asked EPA to withdraw the proposed
guidance and, in its place, use the National Primary Drinking Water
Regulations for Radionuclides as the basis for any emergency response
measures regarding drinking water.
    Commenters also asserted that the proposed drinking water PAG did
not conform to the National Environmental Policy Act (NEPA) as well as
other regulations dealing with cleanup and waste management of
radioactive contaminants. Commenters expressed doubts regarding the
duration that the drinking water PAG would be implemented after an
incident, claiming that the drinking water PAG could be in place for
timeframes exceeding one year.
    In response to comments, EPA has amended the drinking water
guidance to emphasize, with regards to the scope of the drinking water
PAG recommendations, that they are only intended to apply to nationally
significant radiological contamination incidents, such as a disaster at
a nuclear power plant, a radiological dispersal device or an improvised
nuclear device, and for a duration that may last for weeks to months
but not longer than one year.
    Some commenters expressed concerns that PAGs would weaken drinking
water standards and regulations. Environmental regulations or standards
are legal limits designed to minimize health effects from everyday
exposure to low levels of radiation over long periods. The PAG levels
are guidance for emergency situations; they do not supplant any
standards or regulations, nor do they affect the stringency or
enforcement of any standards or regulations. The PAG levels are
intended to be used only in an emergency when radiation levels have
already exceeded environmental standards. The PAG levels trigger public
safety measures to minimize radiation exposures during an emergency.
    To develop guidance on drinking water considerations, EPA based its
assessment on assumptions limiting exposures to a one-year timeframe.
EPA expects that the responsible party for any drinking water system
adversely impacted during a radiation incident will take action to
return to compliance with Safe Drinking Water Act levels as soon as
practicable.
    The National Primary Drinking Water Regulations establish
regulatory limits designed to minimize health effects from everyday
exposure to low levels of radiation over long periods; those limits are
not changing with this action. Emergency guides are temporary measures
to minimize risk while enabling distribution of limited resources
during an emergency response.
    Estimated risk of excess cancer cases for lifetime exposure (70
years) to beta emitting radioactive contaminants in drinking water at 4
mrem/yr (the MCL) generally falls in a range of risks deemed acceptable
by EPA. Estimated risks associated for a shorter (one-year) exposure to
radioactivity in drinking water at the proposed PAG levels fall within
a similar risk range.
    The drinking water PAG meets NEPA policy goals because it is based
on analyses, documentation and review procedures that are functionally
equivalent to NEPA. ``Activities for the development of federal
radiation regulations and guidance in accordance with the Atomic Energy
Act of 1954 are functionally equivalent to NEPA'' (63 FR 58045, October
29, 1998).
    Commenters questioned whether the EPA considered cumulative effects
in developing the drinking water PAG. In developing the PAG Manual, EPA
considered the potential for cumulative exposure from multiple exposure
pathways including: plume inhalation, immersion, ground shine, drinking
water ingestions and food, among others. However, EPA has determined
that for implementation purposes, it is impractical to compartmentalize
joint protective actions, since allocations of dose to different
segments of the population based on individual exposure routes will
depend on site-specific circumstances and are impossible to quantify.
While the PAGs for the various pathways are separate, emergency
management officials should consider all relevant exposure routes when
making protective action decisions in an emergency. In addition,
incident-specific factors like geographical location, ongoing weather,
the isotopes released and population affected should be considered
after a contamination event, and specific exposure routes should be
identified to allow different types of protective actions to be aimed
at the specific risks to be avoided.

    Several commenters from state emergency management agencies and
radiation control programs expressed support for EPA's proposal,
stating that the guidance was well developed and technically sound; and
that the incorporation of the drinking water PAG into the PAG Manual is
a critical aspect of a coordinated emergency response after a radiation
contamination incident.
    Some commenters suggested that while they support the incorporation
of the drinking water PAG, they believe the proposed PAG was too
conservative and that EPA should consider establishing the PAG in the
2,000 to 10,000 mrem range.
    EPA believes that the drinking water PAG should be consistent with
and within the range of currently available guidance for other exposure
pathways during the intermediate phase. Also, when possible, the
drinking water PAG recommendations should be based on an additional
level of protection to sensitive life-stages. For short-term incidents,
as explained in the PAG Manual, it is appropriate to have a 500 mrem
PAG level for drinking water for the general population and a lower-
tier PAG level of 100 mrem for persons at sensitive life-stages,
including pregnant women, nursing women, and children 15 years old and
under. This approach of setting a two-tier level of protection
incorporates suggestions submitted by commenters regarding the adequate
consideration of children and sensitive subpopulations.
    There is an abundance of caution built into the derivation of the
drinking water PAG through a variety of assumptions, including
conservative dose-response modeling; selection of the most sensitive
life stages to derive the PAG for children through age 15 years; and,
the assumption of no decay of isotopes over the calculated one-year
exposure period, which may be appropriate in some situations. This
action ensures that the protective measures it recommends are
appropriate for all members of the public, including sensitive
subpopulations.

E. What is the timeframe for implementation of this PAG Manual?

    Emergency management and radiation protection organizations that
use the PAGs in their emergency plans are encouraged to incorporate
this updated guidance as soon as possible. This may entail training, as
well as the update of plans and procedures. Outreach and technical
training will be conducted by EPA, the Federal Radiological Monitoring
and Assessment Center and interagency partners of the PAG Subcommittee.
FEMA expects certain organizations associated with nuclear power plant
operations to use the PAG Manual in developing their emergency
management plans. FEMA plans to begin using the new PAG Manual during
their evaluation of offsite response organizations around nuclear power
facilities 12 months after the publication of this document in the
Federal Register.
    For further information and related guidelines, see the EPA Web
site: http://www.epa.gov/radiation/protective-action-guides-pags.
Keywords include: drinking water, radiation, radiological incident,
emergency and protective action guide.

    Dated: January 10, 2017.
Joel Beauvais,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2017-01230 Filed 1-18-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 11, 2009 (Volume 74, Number 237)]
[Rules and Regulations]
[Page 65690-65692]
[DOCID:fr11de09-9]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0484]
RIN 1625-AA00

Safety Zone; San Diego Parade of Lights Fireworks; San Diego Bay,
CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard proposes a safety zone upon the navigable
waters of San Diego Bay in San Diego, CA in support of the San Diego
Parade of Lights Fireworks. This safety zone is necessary to provide
for the safety of the participants, crew, spectators, participating
vessels, and other users of the waterway. Persons and vessels are
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port or his
designated representative.

DATES: This rule is effective from 5:30 p.m. to 10 p.m., each day, on
December 13, 2009, and December 20, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2009-0484 and are available online by going to
http://www.regulations.gov, inserting USCG-2009-0484 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Petty Officer Shane Jackson, Waterways
Management, U.S. Coast Guard Sector San Diego at telephone 619-278-
7262, E-mail<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On September 29, 2009 we published a notice of proposed rulemaking
(NPRM) entitled Safety Zone; San Diego Parade of Lights Fireworks; San
Diego, CA in the Federal Register (74 FR 49831). We received no
comments on the proposed rule. Additionally, no public meeting was
requested, and none was held.

Background and Purpose

    Fireworks & Stage FX Inc is sponsoring the San Diego Parade of
Lights Fireworks, which will include a fireworks presentation from a
barge in San Diego Bay. This temporary safety zone is necessary to
provide for the safety of the crew, spectators, participants, and other
vessels and users of the waterway.

Discussion of Comments and Changes

    No comments were submitted in response to the NPRM. After
publication of the NPRM, the sponsor informed the Coast Guard that
changes to the fireworks show plans required enlargement of the safety
zone. The NPRM described a safety zone extending in a 400 foot radius
around a barge in approximate position 32[deg]43'23'' N,
117[deg]11'57'' W. Instead, in order to protect members of the public
from the hazards associated with fireworks displays, the zone will
extend in a 600 foot radius from the same approximate position. Vessel
traffic will continue to be able to pass safely around the zone, and no
other negative impacts are expected to result from this change.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. This
determination is based on the size and location of the safety zone.
Commercial vessels will not be hindered by the safety zone.
Recreational vessels will not be allowed to transit through the
designated safety zone during the specified times unless authorized to
do so by the Captain of the Port or his designated representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in a portion of the San Diego Bay from 5:30 p.m. to 10 p.m.
on December 13 and 20, 2009.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessel
traffic can pass safely around the zone. Additionally, before the
effective period, the Coast Guard will publish a local notice to
mariners (LNM).

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or

complain about this rule or any policy or action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g.), of the Instruction because the rule involves the
establishment of a safety zone. An environmental analysis checklist and
a categorical exclusion determination are available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 701,
3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and
160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T11-222 to read as follows:

Sec.  165.T11-222  Safety zone; San Diego Parade of Lights Fireworks;
San Diego Bay, California.

    (a) Location. The following area is a safety zone: All waters of
San Diego Bay, from surface to bottom, within a 600 foot radius around
a barge in approximate position 32[deg]43'23'' N, 117[deg]11'57'' W.
    (b) Enforcement Period. This section will be enforced from 5:30
p.m. to 10 p.m. on both December 13, 2009, and December 20, 2009. If
the event concludes prior to the scheduled termination time, the
Captain of the Port will cease enforcement of this safety zone and will
announce that fact via Broadcast Notice to Mariners.
    (c) Definitions. As used in this section, designated representative
means any commissioned, warrant, or petty officers of the Coast Guard
on board Coast Guard, Coast Guard Auxiliary, or local, State, or
Federal law enforcement vessels who have been authorized to act on the
behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander. The
Patrol Commander may be contacted on VHF-FM Channel 16.
    (3) All persons and vessels must comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio,

flashing light, or other means, the operator of a vessel must proceed
as directed.
    (5) The Coast Guard may be assisted by other Federal, State, or
local agencies.

    Dated: November 19, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-29489 Filed 12-10-09; 8:45 am]

BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2964-2968]
[FR Doc No: 2022-00873]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93960; File No. SR-NYSEArca-2021-109]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE
Arca Equities Fees and Charges

January 12, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 30, 2021, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Equities Fees and
Charges (``Fee Schedule'') to adopt an alternative requirement to
qualify for the Tape B Tier 3 pricing tier. The Exchange proposes to
implement the fee change effective January 3, 2022. The proposed rule
change is available on the

Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend the Fee Schedule to adopt an
alternative requirement to qualify for the Tape B Tier 3 pricing tier.
The Exchange proposes to implement the fee change effective January 3,
2022.
Background
    The Exchange operates in a highly competitive market. The
Commission has repeatedly expressed its preference for competition over
regulatory intervention in determining prices, products, and services
in the securities markets. In Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (File No. S7-10-04) (Final
Rule) (``Regulation NMS'').
---------------------------------------------------------------------------

    While Regulation NMS has enhanced competition, it has also fostered
a ``fragmented'' market structure where trading in a single stock can
occur across multiple trading centers. When multiple trading centers
compete for order flow in the same stock, the Commission has recognized
that ``such competition can lead to the fragmentation of order flow in
that stock.'' \4\ Indeed, equity trading is currently dispersed across
16 exchanges,\5\ numerous alternative trading systems,\6\ and broker-
dealer internalizers and wholesalers, all competing for order flow.
Based on publicly available information, no single exchange currently
has more than 18% market share.\7\ Therefore, no exchange possesses
significant pricing power in the execution of equity order flow. More
specifically, the Exchange currently has less than 12% market share of
executed volume of equities trading.\8\
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    \4\ See Securities Exchange Act Release No. 61358, 75 FR 3594,
3597 (January 21, 2010) (File No. S7-02-10) (Concept Release on
Equity Market Structure).
    \5\ See Cboe U.S Equities Market Volume Summary, available at
https://markets.cboe.com/us/equities/market_share. See generally
https://www.sec.gov/fast-answers/divisionsmarketregmrexchangesshtml.html.
    \6\ See FINRA ATS Transparency Data, available at https://otctransparency.finra.org/otctransparency/AtsIssueData. A list of
alternative trading systems registered with the Commission is
available at https://www.sec.gov/foia/docs/atslist.htm.
    \7\ See Cboe Global Markets U.S. Equities Market Volume Summary,
available at http://markets.cboe.com/us/equities/market_share/.
    \8\ See id.
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    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
move order flow, or discontinue or reduce use of certain categories of
products. While it is not possible to know a firm's reason for shifting
order flow, the Exchange believes that one such reason is because of
fee changes at any of the registered exchanges or non-exchange venues
to which a firm routes order flow. With respect to non-marketable order
flow that would provide liquidity on an Exchange against which market
makers can quote, ETP Holders can choose from any one of the 16
currently operating registered exchanges to route such order flow.
Accordingly, competitive forces constrain exchange transaction fees
that relate to orders that would provide liquidity on an exchange.
Proposed Rule Change
    Currently, under the Tape B Tier 3 pricing tier, an ETP Holder
could qualify for a credit of $0.0025 per share \9\ for adding
liquidity in Tape B Securities if such ETP Holder (1) has Adding ADV of
Tape B CADV that is equal to at least 0.20% of the Tape B CADV and (2)
has Market Maker Electronic Posting Volume of TCADV of at least 0.50%
by an OTP Holder or OTP Firm affiliated with the ETP Holder.
---------------------------------------------------------------------------

    \9\ Under Section III of the Fee Schedule--Standard Rates, ETP
Holders receive a credit of $0.0020 per share for orders that add
liquidity in Tape B securities. Additionally, in securities priced
at or above $1.00, an additional credit in Tape B securities may be
available to LMMs and to Market Makers affiliated with LMMs that add
displayed liquidity based on the number of Less Active ETP
Securities in which the LMM is registered as the LMM. The applicable
tiered-credits are noted in the Fee Schedule under LMM Transaction
Fees and Credits.
---------------------------------------------------------------------------

    The Exchange proposes to adopt an alternative requirement to
qualify for Tape B Tier 3 credit. As proposed, an ETP Holder could
qualify for the Tape B Tier 3 credit of $0.0025 per share for adding
liquidity in Tape B securities if such ETP Holder has Adding ADV of
Tape B CADV that is equal to at least 0.15% over the ETP Holder's April
2020 Adding ADV taken as a percentage of Tape B CADV.
    The Exchange is not proposing any change to the level of Tape B
Tier 3 credits.
    The proposed rule change to adopt an alternative requirement to
qualify for the existing credit is designed to incentivize ETP Holders
to increase liquidity-providing orders in Tape B securities they send
to the Exchange, which would support the quality of price discovery on
the Exchange and provide additional liquidity for incoming orders.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\10\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\11\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    As discussed above, the Exchange operates in a highly fragmented
and competitive market. The Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \12\
---------------------------------------------------------------------------

    \12\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow, or discontinue or reduce use of certain categories of

products, in response to fee changes. With respect to non-marketable
orders that provide liquidity on an Exchange, ETP Holders can choose
from any one of the 16 currently operating registered exchanges to
route such order flow. Accordingly, competitive forces reasonably
constrain exchange transaction fees that relate to orders that would
provide displayed liquidity on an exchange. Stated otherwise, changes
to exchange transaction fees can have a direct effect on the ability of
an exchange to compete for order flow.
    In particular, the Exchange believes the proposed rule change is
reasonable because it provides an additional opportunity for ETP
Holders to receive an existing rebate on qualifying orders in a manner
that incentivizes order flow on the Exchange's equities platform. The
Exchange believes the proposed change to adopt an alternative
requirement to qualify for the Tape B Tier 3 pricing tier is reasonable
because it provides ETP Holders with an additional way to qualify for
the pricing tier's credit by providing liquidity in Tape B securities
each month over a predetermined baseline, and which does not include an
options component. The Exchange believes that the proposed alternative
to qualify for the pricing tier utilizing an equities-only requirement
is reasonable because the proposal provides firms that do not have an
affiliation with an OTP Holder or OTP Firm the ability to reach the
proposed volume tier by sending liquidity providing orders in tape B
securities, thereby creating an incentive for ETP Holders to bring
increased order flow to a public exchange.
    The Exchange believes the proposed change to adopt an alternative
method to qualify for existing credits is reasonable as these changes
would provide an incentive for ETP Holders to direct their order flow
to the Exchange and provide meaningful added levels of liquidity in
order to qualify for the existing credit, thereby contributing to depth
and market quality on the Exchange.
    As noted above, the Exchange operates in a highly competitive
environment, particularly for attracting order flow that provides
displayed liquidity on an exchange. More specifically, the Exchange
notes that greater add volume order flow may provide for deeper, more
liquid markets and execution opportunities at improved prices, which
the Exchange believes would incentivize liquidity providers to submit
additional liquidity and enhance execution opportunities.
    The Exchange notes that volume-based incentives and discounts have
been widely adopted by exchanges, including the Exchange, and are
reasonable, equitable and not unfairly discriminatory because they are
available to all ETP Holders on an equal basis. They also provide
additional benefits or discounts that are reasonably related to the
value of the Exchange's market quality and associated higher levels of
market activity, such as higher levels of liquidity provision and/or
growth patterns. Additionally, the Exchange is one of many venues and
off-exchange venues to which market participants may direct their order
flow, and it represents a small percentage of the overall market.
Competing exchanges offer similar tiered pricing structures to that of
the Exchange, including schedules of rebates and fees that apply based
on members achieving certain volume thresholds.
    The Exchange believes its proposal equitably allocates its fees and
credits among its market participants.
    The Exchange believes that the proposal represents an equitable
allocation of fees and credits and is not unfairly discriminatory
because it would apply uniformly to all ETP Holders, in that all ETP
Holders will be eligible for the existing credit and have the
opportunity to meet the tier's criteria and receive the applicable
rebate if such criteria is met. The existing rebate would apply
automatically and uniformly to all ETP Holders that achieve the
corresponding criteria. The proposed change is designed as an incentive
to any and all liquidity providers interested in meeting the tier
criteria to submit order flow to the Exchange and each will receive the
associated rebate if the tier criteria is met. While the Exchange has
no way of knowing whether this proposed rule change would definitively
result in any particular ETP Holder qualifying for the existing credit
by utilizing the proposed alternative requirement, the Exchange
anticipates a number of ETP Holders would be able to meet, or will
reasonably be able to meet, the proposed criteria. However, without
having a view of activity on other markets and off-exchange venues, the
Exchange has no way of knowing whether this proposed rule change would
result in any ETP Holder meeting the alternative requirement and
qualifying for the Tape B Tier 3 rebate. As stated, the proposed
alternative requirement to qualify for an existing credit is designed
to provide an incentive for ETP Holders to submit additional liquidity
in Tape B securities.
    The Exchange believes that the proposal is not unfairly
discriminatory.
    The Exchange believes it is not unfairly discriminatory to provide
an alternative way to qualify for the per share credit under the Tape B
Tier 3 pricing tier, as the credit would be provided on an equal basis
to all ETP Holders that meet the proposed alternative requirement.
Further, the Exchange believes the proposed alternative requirement
would incentivize ETP Holders to send their liquidity providing orders
in Tape B securities to the Exchange to qualify for the existing
rebate.
    The Exchange believes that the proposed alternative requirement to
qualify for the Tape B Tier 3 credit is not unfairly discriminatory
because it would be available to all ETP Holders on an equal and non-
discriminatory basis. In this regard, the Exchange notes that ETP
Holders that do not meet the proposed alternative requirement would
continue to have the opportunity to qualify for the Tape B Tier 3
credit by satisfying the current requirement, which would not change as
a result of this proposal.
    The Exchange also believes that the proposed rule change is not
unfairly discriminatory because it is reasonably related to the value
to the Exchange's market quality associated with higher volume. The
proposed change to the Tape B Tier 3 pricing tier is designed as an
incentive to any and all ETP Holders interested in meeting the tier
criteria to submit additional order flow to the Exchange and each will
receive the existing rebate if the tier criteria is met. The Exchange
also notes that the proposed rule change will not adversely impact any
ETP Holder's pricing or its ability to qualify for other tiers. Rather,
should an ETP Holder not meet the Tape B Tier 3 pricing tier's
criteria, the ETP Holder will merely not receive the corresponding
rebate.
    In the prevailing competitive environment, ETP Holders are free to
disfavor the Exchange's pricing if they believe that alternatives offer
them better value. Moreover, this proposed rule change neither targets
nor will it have a disparate impact on any particular category of
market participant. The Exchange believes that this proposal does not
permit unfair discrimination because the changes described in this
proposal would be applied uniformly to all similarly situated ETP
Holders and all ETP Holders would be subject to the same requirements.
Accordingly, no ETP Holder already operating on the Exchange would be
disadvantaged by the proposed allocation of fees. The Exchange further
believes that the proposed changes would not permit unfair
discrimination among ETP Holders because the Tape B Tier 3 credit

would be available equally to all ETP Holders.
    Finally, the submission of orders to the Exchange is optional for
ETP Holders in that they could choose whether to submit orders to the
Exchange and, if they do, the extent of its activity in this regard.
The Exchange believes that it is subject to significant competitive
forces, as described below in the Exchange's statement regarding the
burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\13\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, as discussed above, the Exchange believes
that the proposed changes would encourage the submission of additional
liquidity to a public exchange, thereby promoting market depth, price
discovery and transparency and enhancing order execution opportunities
for ETP Holders. As a result, the Exchange believes that the proposed
change furthers the Commission's goal in adopting Regulation NMS of
fostering integrated competition among orders, which promotes ``more
efficient pricing of individual stocks for all types of orders, large
and small.'' \14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(8).
    \14\ See Securities Exchange Act Release No. 51808, 70 FR 37495,
37498-99 (June 29, 2005) (S7-10-04) (Final Rule).
---------------------------------------------------------------------------

    Intramarket Competition. The Exchange believes the proposed
amendment to its Fee Schedule would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange does not believe that the proposed
change represents a significant departure from previous pricing offered
by the Exchange or its competitors. The proposed change is designed to
attract additional order flow to the Exchange, in particular with
respect to Tape B securities. The Exchange believes that the proposed
adoption of an alternative requirement to qualify for an established
credit under the Tape B Tier 3 pricing tier would incentivize market
participants to direct liquidity adding order flow to the Exchange,
bringing with it additional execution opportunities for market
participants and improved price transparency. Greater overall order
flow, trading opportunities, and pricing transparency benefits all
market participants on the Exchange by enhancing market quality and
continuing to encourage ETP Holders to send orders to the Exchange,
thereby contributing towards a robust and well-balanced market
ecosystem.
    Intermarket Competition. The Exchange operates in a highly
competitive market in which market participants can readily choose to
send their orders to other exchange and off-exchange venues if they
deem fee levels at those other venues to be more favorable. As noted
above, the Exchange's market share of intraday trading (i.e., excluding
auctions) is currently less than 12%. In such an environment, the
Exchange must continually adjust its fees and rebates to remain
competitive with other exchanges and with off-exchange venues. Because
competitors are free to modify their own fees and credits in response,
and because market participants may readily adjust their order routing
practices, the Exchange does not believe its proposed fee change can
impose any burden on intermarket competition.
    The Exchange believes that the proposed change could promote
competition between the Exchange and other execution venues, including
those that currently offer similar order types and comparable
transaction pricing, by encouraging additional orders to be sent to the
Exchange for execution.

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

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

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \15\ of the Act and subparagraph (f)(2) of Rule
19b-4 \16\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEArca-2021-109 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2021-109. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal offices of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All

submissions should refer to File Number SR-NYSEArca-2021-109, and
should be submitted on or before February 9, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-00873 Filed 1-18-22; 8:45 am]
BILLING CODE 8011-01-P


Docket Index Table of Contents
A.	U.S. EPA Rulemakings, Guidance Documents, Informational Memoranda, Technical Support Documents, Memoranda to File, and Data Analysis Documents	1
B.	State Plans, Rules, Support Documents, Reports, and Correspondence	2
C.	Notice of Proposed Rulemaking	3
D.	Public Comments and Related Documents	3
E.	Additional Documents Considered for Final Rulemaking	3
F.	Notice of Final Rulemaking	4

U.S. EPA Rulemakings, Guidance Documents, Informational Memoranda, Technical Support Documents, Memoranda to File, and Data Analysis Documents
Rulemakings
52 FR 24634, Revisions to the National Ambient Air Quality Standards for Particulate Matter, Final rule (July 1, 1987).
71 FR 61144, National Ambient Air Quality Standards for Particulate Matter, Final rule (October 17, 2006).
77 FR 32024, Designation of Areas for Air Quality Planning Purposes; State of Arizona; Pinal County; PM10, Final rule (May 31, 2012).
85 FR 37756, Finding of Failure to Attain the 1987 24-Hour PM10 Standard; Reclassification as Serious Nonattainment; Pinal County, Arizona, Final rule (June 24, 2020).
86 FR 1347, Partial Approval and Partial Disapproval of Air Quality Implementation Plans; Arizona; West Pinal County; 1987 PM10 Nonattainment Area Requirements, Proposed rule (January 8, 2021).
86 FR 38928, Finding of Failure to Submit a State Implementation Plan to Meet the 1987 24-Hour PM10 Standard; Moderate Area Requirements; West Pinal County; Arizona, Final rule (July 23, 2021).
 Technical Support Documents, Memoranda to File, and Data Analysis Documents
Letter dated November 30, 2022, from Elizabeth J. Adams, Director, Air and Radiation Division, EPA Region IX, to Misael Cabrera, Director, ADEQ, Subject: "Completeness Finding for State Implementation Plan (SIP) Submission for West Pinal County for the 1987 PM10 National Ambient Air Quality Standards (NAAQS) and Termination of Clean Air Act (CAA) Sanctions Clocks."
Letter dated October 26, 2020, from Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, to Michael Sundblom, Director, Pinal County Air Quality Control District, with enclosure.
Letter dated October 27, 2021, from Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, to Michael Sundblom, Director, Pinal County Air Quality Control District, with enclosure.
Letter dated October 28, 2022, from Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, to Michael Sundblom, Director, Pinal County Air Quality Control District, with enclosure.
EPA Region IX, Technical Systems Audit of the Ambient Air Monitoring Program: Pinal County Air Quality Control District, April 1 - 3, 2019 (Final Report dated September 2019).
EPA AQS Design Value Report, AMP 480, dated January 5, 2023. (User ID: JCARLSTAD, Report Request ID: 2069517).
Map of Federally-Recognized Tribes in EPA's Pacific Southwest (Region IX) (also available at https://www.epa.gov/tribal-pacific-sw/map-federally-recognized-tribes-epas-pacific-southwest-region-9).

State Plans, Rules, Support Documents, Reports, and Correspondence
 Letter dated May 17, 2021, from Daniel Czecholinski, Director, Air Quality Division, ADEQ, to Deborah Jordan, Acting Regional Administrator, EPA Region IX, Subject: "RE: Withdrawal from EPA Consideration of the 2015 Arizona State Implementation Plan Revision: West Pinal County PM10 Nonattainment Area."
West Pinal PM10 Plan, Appendix E, Exhibit 2, Resolution to Adopt the 2022 Serious Area Particulate Plan for PM-10 for the West Pinal County Nonattainment Area.
Letter dated May 31, 2022, from Daniel Czecholinski, Director, Air Quality Division, ADEQ, to Martha Guzman, Regional Administrator, EPA Region IX, Subject: "Arizona State Implementation Plan Revision, Maricopa Association of Governments 2022 Serious Area Particulate Plan for PM-10 for the West Pinal County Nonattainment Area."
Pinal County Air Quality Control District, 2020 Ambient Monitoring Network Plan and 2019 Data Summary.
Pinal County Air Quality Control District, 2021 Ambient Monitoring Network Plan and 2020 Data Summary.
Pinal County Air Quality Control District, 2022 Ambient Monitoring Network Plan and 2021 Data Summary.
Letter dated April 26, 2021, from Josh DeZeeuw, Air Quality Manager, Pinal County Air Quality Control District, to Gwen Yoshimura, EPA Region IX, Subject: "RE: AQS Data Certification  -  2020," with enclosure.
Letter dated April 26, 2022, from Josh DeZeeuw, Air Quality Manager, Pinal County Air Quality Control District, to Gwen Yoshimura, EPA Region IX, Subject: "RE: AQS Data Certification  -  2021," with enclosure.
Notice of Proposed Rulemaking
88 FR 9812, Finding of Failure to Attain the 1987 24-Hour PM10 Standards; Pinal County, Arizona, Proposed rule (February 15, 2023).
Public Comments and Related Documents
Comment submitted March 17, 2023, from Sierra Club to docket number EPA-R09-OAR-2023-0035, with attached letter dated March 17, 2023, from Sandy Bahr, Chapter Director, Sierra Club  -  Grand Canyon Chapter, to Ashley Graham, Air Planning Office (AIR-2), EPA Region IX.
Comment submitted March 17, 2023, from Dan Blackson, to docket number EPA-R09-OAR-2023-0035.
Additional Documents Considered for Final Rulemaking
Letter dated May 4, 2023, from Elizabeth Adams, Director, Air and Radiation Division, EPA Region IX, to Scott DiBiase, Interim Director, Pinal County Air Quality Control District, with enclosure: EPA Region IX, Technical Systems Audit of the Ambient Air Monitoring Program: Pinal County Air Quality Control District, September 13 - 15, 2022 (Final Report dated May 2023).
Letter dated April 27, 2023, from Josh DeZeeuw, Air Quality Manager, Pinal County Air Quality Control District, to Dena Vallano, EPA Region IX, Subject: "RE: AQS Data Certification  -  2022," with enclosure.
EPA AQS Design Value Report, AMP 480, dated May 23, 2023. (User ID: JCARLSTAD, Report Request ID: 2107794).
EPA Region IX, "Federally-Recognized Tribes in EPA's Pacific Southwest (Region 9)".
Notice of Final Rulemaking
88 FR 47026, Finding of Failure to Attain the 1987 24-Hour PM10 Standards; Pinal County, Arizona, Final rule (July 21, 2023).


Zinc Pyrithione Summary May 12, 2004 USES Zinc Pyrithione ( also known as Zinc Omadine ® or Zinc 2 pyridinethiol 1 oxide) is a materials preservative used to prevent microbial degradation and deterioration in a wide variety of food/ drinking water contact, and non food contact finished manufactured articles ( treated articles), and in their precursor materials. It is considered to have bacteriostat, fungistat, mildewstat, and algaestat properties. It is conditionally registered until 6/ 30/ 05 for antifoulant boat paints to control the growth of slime, algae, and marine fouling organism ( e. g., barnacles, tubeworms, etc.) below the water line on recreational and commercial boat hulls in fresh, salt, or brackish water. It is also used to control bacterial and fungal growth on laundered products in industrial settings.

The largest use for zinc pyrithione is non pesticidal ( i. e., control of dandruff, seborrheic dermatitis, and psoriasis), and is regulated by FDA. It is the active ingredient in many antidandruff shampoos.

FORMULATIONS Zinc pyrithione is added as a liquid, powder or aqueous dispersion during the manufacturing process of treated articles and their precursor materials. Zinc pyrithione is added usually by metering pump if it is a liquid, and by open pouring if it is the powder form. It is added at a point where thorough mixing will take place.

PRODUCTION Total U. S. zinc pyrithione annual production in 2003 for pesticidal purposes was about 241,000 pounds, calculated as pure active ingredient. Use of zinc pyrithione for nonpesticidal FDA regulated applications accounted for the vast majority of total chemical production.

HEALTH EFFECTS Zinc pyrithione is moderately toxic via acute oral exposure ( LD50 is 267 mg/ kg; Toxicity Category II), and of low toxicity by the dermal route ( LD50 > 2000 mg/ kg; Toxicity Category III) and inhalation route of exposure (> 0.61 mg/ L; Toxicity Category III). Zinc pyrithione is a severe eye irritant ( Toxicity category I) but does not appear to demonstrate significant dermal irritation ( Toxicity category IV), and is not a dermal sensitizer.

Repeated dose ( 13 weeks) toxicity studies indicate that by the dermal route, zinc pyrithione is relatively non toxic ( decreased food consumption, decreased body weight gain, decreased food efficiency at the limit dose of 1000 mg/ kg/ day). The oral route toxicity is significantly greater ( increased relative organ weights, clinical toxicity, and hindlimb weakness at 3.75 mg/ kg/ day).

Page 1 of 5 Page 2 of 5 In both oral developmental studies in rats and rabbits, there was no quantitative evidence of increased susceptibility [ i. e., maternal and developmental no observed adverse effect levels ( NOAELs) were the same]. There was however, qualitative evidence of increased susceptibility ( i. e., fetal effects such as skeletal effects, and a decreased number of viable fetuses were considered to be more severe in the presence of minimal maternal toxicity).

Significant nervous system deficits following either acute or subchronic oral administration are observed with zinc pyrithione, including cholinergic effects, hindlimb weakness, and peripheral neuropathy in the form of axonal degeneration. Neurotoxicity studies are thus triggered ` for cause' in order to properly characterize the effects of zinc pyrithione on nervous system structure and function as well as a more adequate identification of the neurotoxic dose response in adults.

RISKS Food Risk   The acute and chronic dietary risk from food alone does not exceed the Agency's level of concern for all populations.

Drinking Water Risk   The acute and chronic dietary risk from drinking water alone does not exceed the Agency's level of concern.

Residential ( Non Occupational) Risk   Residential post application exposures show that short, intermediate, and long term dermal risks do not exceed the Agency's level of concern ( i. e., MOEs > 300. The MOEs are greater than 300 for adult/ child contact with zinc pyrithione treated rubber/ plastic articles, and short and intermediate term incidental oral exposure scenarios for infants/ children that could contact zinc pyrithione treated toys via toy to mouth, and hand to mouth exposures.

The following residential handler exposure scenarios for application of paints exceed the Agency's level of concern ( i. e., MOE's < 300), and are therefore, are of concern.

° Residential handlers that paint using an airless sprayer: antifoulant paint use: dermal MOE = 100 for large boats; inhalation MOEs = 6 33 material preservative use in paints: dermal MOE = 118; inhalation MOE = 15 ° Residential handlers that paint using a brush: antifoulant paint use for all boat sizes: dermal MOE = 22 120; inhalation MOE = 5 140.

° Residential handlers that paint using an aerosol spray can ( inhalation MOE = 271). Page 3 of 5 The majority of the painting exposure is attributed to the hands, and most of the dermal MOEs would not be of concern if painters wore chemical resistant gloves. However, it is not current Agency policy to assume personal protective equipment ( PPE) for residential handlers. Requiring the general public to wear gloves and respirators during application of paints is neither feasible, nor enforceable.

Aggregate Risk   Aggregate risk assessment for food, water, and residential exposures were conducted for acute ( 1 day), short term ( 1 30 days), intermediate term ( 1 6 months) and chronic ( several months to lifetime) exposures. Dermal and oral exposures were not combined in the aggregate assessment because of different toxicological endpoints. Short and intermediate term aggregate risks are considered together because the same exposure data are used for short and intermediate term exposures, and the endpoint of concern is the same for short as for intermediate term non dietary exposures.

The acute aggregate risk from indirect food contact and drinking water do not exceed the Agency's level of concern for adults or children.

The short and intermediate term oral aggregate risks for dietary, residential ( incidental oral) and drinking water exposure do not exceed the Agency's level of concern for adult males and females and infants/ children.

Dermal short and intermediate term aggregate MOEs for an adult resident that could simultaneously contact shoe liners, paint containing zinc pyrithione ( as a material preservative) via an aerosol can and anti dandruff shampoo do not exceed the Agency's level of concern. Dermal exposures that already exceed the Agency's level of concern were not included in the dermal aggregate risk estimates ( i. e., antifoulant paint use, and some materials preservative paint use).

For residential paint applications using a paintbrush, the dermal aggregate MOEs are slightly less than the target MOE of 300 ( 270) and exceed the Agency's level of concern.

The only uses which pose inhalation exposure are from the residential handler applications of paint, which have MOEs that exceed the Agency's level of concern. These inhalation MOEs range from 5 140 for antifoulant paint use, and 15 271 for paint containing zinc pyrithione as a materials preservative. However, these risk estimates are conservative because they are based on a whole body rat 90 day inhalation study.

Occupational ( Worker) Risks   For mixing/ loading liquids and powders in closed systems ( i. e., using a metered pump, or automatic dispensing techniques), the margin of exposure ( MOE) calculations indicate risks ( i. e., target MOEs

100) that do not exceed the Agency's level of concern for the dermal and inhalation exposure scenarios assessed. Page 4 of 5 The dermal exposure risks do not exceed the Agency's level of concern ( i. e., MOE

100) for potential short term, intermediate term, and long term exposures during open mixing/ loading of powders and liquids, for all the scenarios assessed. Also, the dermal and inhalation MOEs for the laundered fabrics scenarios were not of concern.

However, the following short, intermediate, and long term exposure scenarios have inhalation MOEs which exceed the Agency's level of concern ( i. e., MOEs < 100). Mitigation measures which can be used to help reduce potential inhalation exposure ( e. g., appropriate PPE, closed delivery systems, etc.) will be discussed and resolved with the registrants.

 Mixing/ loading/ applying powders and liquids for general preservative use patterns using open pour methods ( inhalation MOE = 50 for liquid formulations; inhalation MOE = 15 for powder formulation);

 Mixing/ loading/ applying powders and liquids for paint preservation using open pour methods ( inhalation MOE = 50 for liquid formulations; inhalation MOE = 15 for powder formulation), and  Handling zinc pyrithione containing paint products ( as a material preservative) using an airless sprayer application method ( inhalation MOEs = 44 and 4.4 with and without the use of an organic vapor respirator as PPE, respectively, and dermal MOE = 74 without the use of gloves as PPE).

ECOLOGICAL RISKS Zinc pyrithione is very highly toxic on an acute basis to freshwater and marine fish and invertebrates, as well as to aquatic plant species. Laboratory tests show adverse chronic impacts on freshwater and marine invertebrate reproduction and growth, at very low ppb concentrations. These adverse growth and reproductive effects also indicate that zinc pyrithione may be a potential endocrine disrupter.

There may be short lived water/ sediment partitioning that could produce adverse acute toxicity exposures to the chemical for benthic, sediment dwelling aquatic organisms. However, since zinc pyrithione degrades fairly quickly in both freshwater and saltwater soils and sediments, and is expected to have low surface water concentrations, any acute exposures are expected to be short lived. It is not expected to persist for long periods in water and microbial soils and sediments, and is therefore not expected to produce adverse chronic effects. Page 5 of 5 HOW THE RISK PICTURE MAY CHANGE Changes and refinements to the risk assessment may occur after consideration of the public comments. The outstanding confirmatory ecological and worker exposure data for the conditional antifoulant paint use may trigger additional studies. The acute and subchronic neurotoxicity data could lead to additional refinements in the risk assessment.


[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14369-14372]
[FR Doc No: 2017-05414]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0017]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Voluntary National Retail Food Regulatory Program
Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the Voluntary National Retail Food Regulatory Program
Standards.

DATES: Submit either electronic or written comments on the collection
of information by May 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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-2011-N-0017 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary National Retail Food
Regulatory Program Standards.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the 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 https://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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the 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.

Voluntary National Retail Food Regulatory Program Standards

OMB Control Number 0910-0621--Extension

    The Voluntary National Retail Food Regulatory Program Standards
(the Program Standards) define nine essential elements of an effective
regulatory program for retail food establishments, establish basic
quality control criteria for each element, and provide a means of
recognition for the State, local, territorial, tribal and Federal
regulatory programs that meet the Program Standards. The program
elements addressed by the Program Standards are as follows: (1)
Regulatory foundation; (2) trained regulatory staff; (3) inspection
program based on Hazard Analysis and Critical Control Point (HACCP)
principles; (4) uniform inspection program, (5) foodborne illness and
food defense preparedness and response; (6) compliance and enforcement;
(7) industry and community relations; (8) program support and
resources; and (9) program assessment. Each standard includes a list of
records needed to document conformance with the standard (referred to
in the Program Standards document as ``quality records'') and has one
or more corresponding forms and worksheets to facilitate the collection
of information needed to assess the retail food regulatory program
against that standard. The respondents are State, local, territorial,
tribal, and potentially other Federal regulatory agencies. Regulatory
agencies may use existing available records or may choose to develop
and use alternate forms and worksheets that capture the same
information.
    In the course of their normal activities, State, local,
territorial, tribal, and Federal regulatory agencies already collect
and keep on file many of the records needed as quality records to
document compliance with each of the Program Standards. Although the
detail and format in which this information is collected and recorded
may vary by jurisdiction, records that are kept as a usual and
customary part of normal Agency activities include inspection records,
written quality assurance procedures, records of quality assurance
checks, staff training certificates and other training records, a log
or database of food-related illness or injury complaints, records of
investigations resulting from such complaints, an inventory of
inspection equipment, records of outside audits, and records of
outreach efforts (e.g., meeting agendas and minutes, documentation of
food safety education activities). No new recordkeeping burden is
associated with these existing records, which are already a part of
usual and customary program recordkeeping activities by State, local,
territorial, tribal and Federal regulatory agencies, and which can
serve as quality records under the Program Standards.
    In April 2016, the Conference for Food Protection (CFP) recommended
that FDA make a change in Program Standard #4--Uniform Inspection
Program, more specifically to change Program Standard #4's Program
Self-Assessment and Verification Audit Form. Once changes have been
incorporated into the 2017 version, it will be available on FDA's Web
site.
    With this change, in order to achieve conformance to Program
Standard #4, jurisdictions must achieve an overall inspection program
performance rating for 20 elements as opposed to 10 elements that were
previously required. The previous 10 elements had several criteria
under one program element. The change to 20 elements allows the
Standard to clearly delineate out each criterion individually rather
than having several criteria under one program element. This
streamlines and clarifies the process in meeting the Standard. As a
result, the assessment review of each inspector's work will now be
required for three joint inspections as opposed to the previously
required two.
    State, local, territorial, tribal and Federal regulatory agencies
that enroll in the Program Standards and seek listing in the FDA
National Registry are required to report to FDA on the completion of
the following three management tasks outlined in the Program Standards:
(1) Conducting a program self-assessment; (2) conducting a risk factor
study of the regulated industry; and (3) obtaining an independent
outside audit (verification audit). The results are reported on forms
formerly known as Form FDA 3519 and Form FDA 3520. Currently FDA is
working to consolidate both Forms FDA 3519 ``FDA National Registry
Report'' and FDA 3520 ``Permission to Publish in National Registry''
into one form thereby reducing the burden by 50 percent. The new Form
FDA 3958 will be provided in the Program Standards document, and will
also be provided on FDA's Web site at: http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/default.htm.
If a regulatory agency follows all the recordkeeping recommendations in
the individual standards and their sample worksheets, it will have all
the information needed to complete the forms.

Recordkeeping

    FDA's recordkeeping burden estimate includes time required for a
state, local, territorial, tribal, or Federal agency to review the
instructions in the Program Standards, compile information from
existing sources, and create any records recommended in the Program
Standards that are not already kept in the normal course of the
agency's usual and customary activities. Sample worksheets are provided
to assist in this compilation. In estimating the time needed for the
program self-assessment (Program Standards 1 through 8, shown in table
1), FDA considered responses from four State and three local
jurisdictions that participated in an FDA Program Standards Pilot
study. Table 2 shows the estimated recordkeeping burden for the
completion of the baseline data collection, and table 3 shows the
estimated recordkeeping burden for the verification audit.
    FDA estimates the burden of this collection of information as
follows:

                        Table 1--Self-Assessment
------------------------------------------------------------------------
                                                              Hours per
             Standard               Recordkeeping activity      record
------------------------------------------------------------------------
No. 1: Regulatory Foundation.....  Self-Assessment:                   16
                                    Completion of worksheet
                                    recording results of
                                    evaluations and
                                    comparison on
                                    worksheets \1\.
No. 2: Trained Regulatory Staff..  Self-Assessment:                 19.3
                                    Completion of CFP Field
                                    Training Manual and
                                    Documentation of
                                    Successful Completion--
                                    Field Training Process;
                                    completion of summary
                                    worksheet of each
                                    employee training
                                    records \1\ \2\.
No. 3: HACCP Principles..........  Self-Assessment:                    4
                                    Completion of worksheet
                                    documentation \1\.

No. 4: Uniform Inspection Program  Self-Assessment:                   19
                                    Completion of worksheet
                                    documentation of
                                    jurisdiction's quality
                                    assurance procedures
                                    \1\ \2\.
No. 5: Foodborne Illness           Self-Assessment:                    5
 Investigation.                     Completion of worksheet
                                    documentation \1\.
No. 6: Compliance Enforcement....  Self-Assessment:                   19
                                    Selection and review of
                                    20 to 70 establishment
                                    files at 25 minutes per
                                    file. Estimate is based
                                    on a mean number of 45.
                                    Completion of worksheet
                                    \1\.
No. 7: Industry & Community        Self-Assessment:                    2
 Relations.                         Completion of worksheet
                                    \1\.
No. 8: Program Support and         Self-Assessment:                    8
 Resources.                         Selection and review of
                                    establishment files \1\.
                                  --------------------------------------
    Total........................  ........................         92.3
------------------------------------------------------------------------
\1\ Or comparable documentation.
\2\ Estimates will vary depending on number of regulated food
  establishments and the number of inspectors employed by the
  jurisdiction.

                    Table 2--Baseline Data Collection
------------------------------------------------------------------------
                                                            Hours per
            Standard             Recordkeeping activity       record
------------------------------------------------------------------------
No. 9: Program Assessment......  Risk Factor Study and              333
                                  Intervention Strategy
                                  \1\.
------------------------------------------------------------------------
\1\ Calculation based on mean sample size of 39 and average FDA
  inspection time for each establishment type. Estimates will vary
  depending on number of regulated food establishments within a
  jurisdiction and the number of inspectors employed by the
  jurisdiction.

                       Table 3--Verification Audit
------------------------------------------------------------------------
                                                            Hours per
            Activity             Recordkeeping activity       record
------------------------------------------------------------------------
Administrative Procedures......  Verification Audit \1\           46.15
------------------------------------------------------------------------
\1\ We estimate that no more than 50% of time spent to complete self-
  assessment of all nine standards is spent completing verification
  audit worksheets. Time will be considerably less if less than nine
  standards require verification audits.

                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average  burden
                                                                        Number of        Number of       Total annual         per
                              Activity                                recordkeepers     records per        records       recordkeeping     Total Hours
                                                                                recordkeeper                        (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping for FDA Worksheets \2\...............................             500                1              500            94.29           47,145
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Or comparable documentation.

    FDA bases its estimates of the number of recordkeepers and the
hours per record on its experience with the Program Standards over the
past 16 years. As of September 30, 2016, 711 jurisdictions were
enrolled in the Program Standards. However, based upon the level of
ongoing support provided by FDA to enrolled jurisdictions and the
number of forms submitted annually, FDA estimates that no more than 500
jurisdictions actively participate in the Program Standards during any
given year. There are approximately 3,000 jurisdictions in the United
States and its territories that have retail food regulatory programs.
Enrollment in the Program Standards is voluntary and, therefore, FDA
does not expect all jurisdictions to participate.
    FDA bases its estimate of the hours per record on the recordkeeping
estimates for the management tasks of self-assessment, risk factor
study, and verification audit (tables 1, 2, and 3 of this document)
that enrolled jurisdictions must perform a total of 471.45 hours (92.3
+ 333 + 46.15 = 471.45). Enrolled jurisdictions must conduct the work
described in tables 1, 2, and 3 over a 5-year period. Therefore FDA
estimates that, annually, 500 recordkeepers will spend 94.29 hours
(471.45 / 5 = 94.29) performing the required recordkeeping for a total
of 47,145 hours as shown in table 4.

Reporting

    Previously, FDA required regulatory jurisdictions that participate
in the Program Standards to submit two forms annually: Form FDA 3519,
``FDA National Registry Report,'' and Form FDA 3520, ``Permission to
Publish in National Registry.'' FDA created a new consolidated FDA Form
3958 that has four parts: Part 1 requires the name and address of the
jurisdiction; name and contact information for the contact person for
this jurisdiction; the jurisdictions Web site address and if the
jurisdiction is willing to serve as an auditor for another
jurisdiction. Part 2 requires information about enrollment, whether
this jurisdiction is a new enrollee and the date of enrollment;
indication whether this jurisdiction would like to be removed from the
jurisdiction listing; indication of updated findings to the self-
assessment or verification audit. Part 3 requires information about
self-assessment findings and verification audit findings; dates when
self-assessment was completed; which standards have been met as
determined by the self-assessment; which standards have been met as
verified by a verification audit including the completion dates. Part 4
requires permission to publish information on FDA's Web site by

checking the appropriate box(es) to indicate what information FDA may
publish on the Web site.
    The reporting burden in table 5 includes only the time necessary to
fill out and send the form, as compiling the underlying information
(including self-assessment reports, Risk Factor Study data collection,
outside audits, and supporting documentation) is accounted for under
the recordkeeping estimates in table 4.
    FDA estimates the reporting burden for this collection of
information as follows:

                                                     Table 5--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
              Activity                      FDA form            Number of     responses per   Total annual       Average  burden per        Total hours
                                                               respondents     respondent       responses         response  (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of ``FDA National         3598..................             500               1             500  0.1 (6 minutes)............              50
 Registry Report''.
Request for documentation of         Conference for Food                500               3           1,500  0.1 (6 minutes)............             150
 successful completion of staff       Protection Training
 training.                            Plan and Log.
                                                            --------------------------------------------------------------------------------------------
    Total..........................  ......................  ..............  ..............  ..............  ...........................             200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimates of the number of respondents and the hours
per response on its experience with the Program Standards. As explained
previously in this document, FDA estimates that no more than 500
Regulatory jurisdictions will participate in the Program Standards in
any given year. FDA estimates a total of 6 minutes annually for each
enrolled jurisdiction to complete the form. FDA bases its estimate on
the small number of data elements on the form and the ease of
availability of the information. FDA estimates that, annually, 500
regulatory jurisdictions will submit one Form FDA 3598 for a total of
500 annual responses. Each submission is estimated to take 0.1 hour (or
6 minutes) per response for a total of 50 hours. In addition, FDA
estimates that, annually, 500 regulatory jurisdictions will submit
three requests for documentation of successful completion of staff
training using the CFP Training Plan and Log for a total of 1,500
annual responses. Each submission is estimated to take 0.1 hour (or 6
minutes) per response for a total of 150 hours. Thus, the total
reporting burden for this information collection is 200 hours.

    Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05414 Filed 3-17-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Page 48950]
[FR Doc No: 2015-20185]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

 In the Matter of DJSP Enterprises, Inc.; Order of Suspension of
Trading

August 12, 2015.
    It appears to the Securities and Exchange Commission
(``Commission'') that there is a lack of current and accurate
information concerning the securities of DJSP Enterprises, Inc. (CIK
No.<PHONE_NUMBER>) (``DJSP''), because there is a lack of adequate and
accurate information concerning DJSP's financial statements contained
in its Form 20-F filed on April 2, 2010, and in its Forms 6-K furnished
on May 28, 2010 and September 22, 2010. DJSP is a British Virgin
Islands corporation based in Plantation, Florida with a class of
securities that was registered with the Commission pursuant to Section
12(b) of the Securities Exchange Act of 1934 (``Exchange Act'') until
June 2011, 90 days after DJSP filed a Form 25 with the Commission
voluntary delisting and deregistering its common stock. DJSP's stock is
currently quoted on OTC Link, operated by OTC Markets Group, Inc.,
under the ticker: DJSP.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of DJSP.
    Therefore, it is ordered, pursuant to Section 12(k) of the Exchange
Act, that trading in the securities of DJSP Enterprises, Inc. is
suspended for the period from 9:30 a.m. EDT on August 12, 2015, through
11:59 p.m. EDT on August 25, 2015.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-20185 Filed 8-12-15; 11:15 am]
 BILLING CODE 8011-01-P