[Federal Register: May 14, 2007 (Volume 72, Number 92)]
[Notices]
[Page 27116-27122]
[DOCID:fr14my07-36]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0291; FRL-8309-2]

Enhancing Environmental Outcomes From Audit Policy Disclosures
Through Tailored Incentives for New Owners; Notice

AGENCY: Environmental Protection Agency.

ACTION: Notice; request for comment.

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SUMMARY: The Environmental Protection Agency (``EPA'' or ``the
Agency'') requests comment on whether and to what extent the Agency
should consider offering tailored incentives to encourage new owners of
regulated entities to discover, disclose, correct, and prevent the
recurrence of environmental violations. The Agency is considering
whether actively encouraging such disclosures has the potential to
yield significant environmental benefit, since new owners may be
particularly well-situated and highly motivated to focus on, and invest
in, making a clean start for their new facilities by addressing
environmental noncompliance.
    Any tailored incentives for new owners would be beyond those
offered as EPA is currently implementing EPA's April 11, 2000 policy on
``Incentives for Self-Policing: Discovery, Disclosure, Correction and
Prevention of Violations,'' commonly referred to as the ``Audit
Policy'' (65 FR 19618). These incentives would be designed to enhance
implementation of the Audit Policy and encourage its use in the new
owner context, but would not constitute a change to the Policy overall.
    After the comment period closes, the Agency plans to review all
comments and decide whether to develop a pilot program to test the
policy of offering tailored incentives to encourage new owners to self-
audit and disclose under the Audit Policy. Should the Agency decide to
proceed, EPA would then publish a second Federal Register notice to
seek comment on a proposed pilot program. After a second round of
public comment, the Agency would publish in the Federal Register: The
final description of the pilot program; an announcement of its start
date; and a description of how its success in achieving increased self-
auditing and disclosure and significant improvement to the environment
will be evaluated.

DATES: EPA urges interested parties to comment in writing on the issues
raised in this notice. Comments must be received by EPA at the address
below no later than July 13, 2007. Comments may also be communicated
orally at two public meetings EPA will hold during the comment period.
The first meeting is scheduled for Washington, DC at the J.W. Marriott
Hotel, 1331 Pennsylvania Ave., NW., on June 12, 2007. The second one is
scheduled for San Francisco at the Palace Hotel, 2 New Montgomery St.,
on June 20, 2007. Both meetings will begin at 10 a.m. and end at 4 p.m.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OECA-2007-0291, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>Attention Docket ID No. EPA-
HQ-OECA-2007-0291.
     Fax:<PHONE_NUMBER>, Attention Docket ID No. EPA-HQ-OECA-
2007-0291.
     Mail: Enforcement and Compliance Docket Information
Center, Environmental Protection Agency, Mailcode: 2822T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No.
EPA-HQ-OECA-2007-0291.
     Hand Delivery: Enforcement and Compliance Docket
Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B
3334, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Reading Room is<PHONE_NUMBER>, and the telephone number for the
Enforcement and Compliance Docket is<PHONE_NUMBER>. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OECA-
2007-0291. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov. The

http://www.regulations.gov Web site is an ``anonymous access'' system, which

means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.regulations.gov your e-mail

address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Enforcement and

Compliance Docket Information Center in the EPA Docket Center (EPA/DC),
EPA West, Room B 3334, 1301 Constitution Avenue, NW., Washington, DC.
The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket is (202)
566-1927.

FOR FURTHER INFORMATION CONTACT: For further information, contact
Caroline Makepeace of EPA's Office of Civil Enforcement, Special
Litigation and Projects Division, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Introduction

    On April 11, 2000, EPA issued its revised final policy on
``Incentives for Self-Policing: Discovery, Disclosure, Correction and
Prevention of Violations,'' commonly referred to as the ``Audit
Policy'' (65 FR 19618). The purpose of the Audit Policy is to enhance
protection of human health and the environment by encouraging regulated
entities to voluntarily discover, disclose, correct and prevent

the recurrence of violations of Federal environmental law. Benefits
available to entities that make disclosures under the terms of the
Audit Policy include reductions in the amount of civil penalties and a
determination not to recommend criminal prosecution of disclosing
entities.
    The Audit Policy program has been a successful effort to date,
resolving disclosed violations with over 3,000 entities. However, more
than half of these disclosures have involved reporting violations
which, while important for public information and safety purposes, may
not produce significant reductions in pollutant emissions once the
violations are corrected. Consistent with EPA's strategic plan, the
Agency's goal is to increase the number of self-disclosures that have
the potential to yield significant environmental benefits while
effecting compliance with Federal environmental requirements. EPA's
recent experience with corporate-wide auditing agreements following a
corporate merger or acquisition has heightened the Agency's interest in
exploring whether encouraging new owners of regulated facilities to
discover, disclose, correct, and prevent the recurrence of
environmental violations would help EPA meet this goal. New owners may
be particularly well-situated and highly motivated to invest in making
a ``clean start'' for their new facilities by: Doing thorough self-
audits of their new facilities; disclosing any violations found;
promptly correcting the violations; and making the substantial
improvements that will enhance their ability to remain in compliance
going forward. Nevertheless, certain disincentives may stand in the way
of new owners that may be interested in taking these steps, and there
may be equitable reasons for considering particular incentives to
encourage self-auditing and disclosure at the time a new owner takes
control. The Agency is interested in developing this idea because of
its potential to enhance EPA's efforts to effectively utilize scarce
government resources by securing significant environmental improvement
as quickly as possible. The Agency is also interested in whether
offering tailored incentives in the new owner context may have
unintended adverse consequences with respect to, for example,
discouraging appropriate due diligence, timely compliance and a level
playing field, or other negative effects. The Agency seeks comment on
the potential for any positive or negative results that might come from
providing such tailored incentives. The Agency also requests comment on
how EPA could most efficiently determine who is a bona-fide new owner,
and how the Agency should evaluate whether such incentives are
successful in securing the prompt correction of environmental
violations and significant improvement to the environment.
    While EPA does not intend to amend the Audit Policy, the Agency is
considering ways to enhance its implementation and encourage its
greater use in new owner situations, particularly with regard to the
disclosure and correction of violations that may yield significant
pollutant reductions. Today, EPA issues this Notice signaling its
intent to consider offering tailored incentives to self-report under
the current Audit Policy for new owners of regulated facilities.
    The purpose of this notice is to (1) solicit information to be used
in helping EPA better understand and formulate decisions about key
issues; and (2) provide notification of open meetings at which EPA
hopes to hear from the public on these issues. Copies of the Agency's
current Audit Policy may be found on the EPA's Web site at http://www.epa.gov/compliance/incentives/auditing/auditpolicy.html
.

B. Background and History of the Audit Policy

1. Overview of the Audit Policy
    The Audit Policy provides incentives for regulated entities to
detect, promptly disclose, expeditiously correct, and prevent the
recurrence of violations of federal environmental requirements. The
Audit Policy contains nine conditions, and entities that meet all of
them are eligible for 100% mitigation of any gravity-based civil
penalties that otherwise could be assessed in settlement. (``Gravity-
based'' penalty refers to that portion of the civil penalty over and
above the portion that represents the entity's economic gain from
noncompliance, known as the ``economic benefit.'') Regulated entities
that do not meet the first condition--systematic discovery of
violations--but meet the other eight conditions are eligible for 75%
mitigation of any gravity-based penalties. For criminal matters, EPA
will generally elect not to recommend criminal prosecution by the
Department of Justice (``DOJ'') or any other prosecuting authority for
a disclosing entity that meets at least conditions two through nine
(i.e., regardless of whether it meets the systematic discovery
requirement) as long as its self-policing, discovery and disclosure
were conducted in good faith and the entity adopts a systematic
approach to preventing recurrence of the violation. The Audit Policy
includes important safeguards to deter violations and protect the
environment. For example, the Audit Policy requires entities to act to
prevent recurrence of violations and to remedy any environmental harm
that may have occurred. Repeat violations, those that result in actual
harm to the environment, and those that may present an imminent and
substantial endangerment are not eligible for relief under the Audit
Policy. Entities and individuals also remain criminally liable for
violations that result from conscious disregard of or willful blindness
to their obligations under the law.
    The Audit Policy and related documents are available on the
Internet at http://www.epa.gov/compliance/incentives/auditing/auditpolicy.html.
 Additional guidance for implementing the Policy in

the context of criminal violations can be found at http://www.epa.gov/compliance/resources/policies/incentives/auditing/auditcrimvio-mem.PDF
.

2. How EPA Implements its Voluntary Disclosure Programs
    EPA's voluntary disclosure policies \1\ are designed to provide
major incentives for regulated entities that voluntarily discover,
promptly disclose, and expeditiously correct violations, rendering
formal EPA investigation and enforcement action unnecessary in most
instances. The policies safeguard human health and the environment by
providing incentives for regulated entities to come into compliance
with the federal environmental laws and regulations, and enable
efficient use of scarce government resources.
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    \1\ Besides the Audit Policy, EPA also implements another
voluntary disclosure policy: The Small Business Compliance Policy
(65 FR 19630), published April 11, 2000.
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    Most self-disclosures come into the Agency on a single facility
basis. However, the Agency sometimes enters into an audit agreement
under which the disclosing entity commits to undertake a comprehensive
multimedia audit that will be conducted at a number of its facilities
over an agreed-upon time frame. Corporate auditing agreements allow
companies to plan a corporate-wide audit with advance understanding
between the company and EPA regarding the scope of the audit, schedules
(audit, reporting, and correction of violations), whether resolution
will be judicial or administrative, and any other

expectations. Such agreements also offer the potential for significant
environmental benefit while providing greater certainty to companies
about their environmental liabilities. Thus, EPA encourages companies
with multiple facilities to take advantage of the Agency's Audit Policy
through use of such corporate auditing agreements.
    Once a regulated entity notifies EPA, in writing, of potential
violations, EPA evaluates the discovery, disclosure, and correction of
the violations against the criteria set forth in the Audit Policy, or
if applicable, the Small Business Compliance Policy, and determines the
appropriate enforcement response. If the disclosure does not meet the
conditions of the applicable policy or the disclosing entity does not
provide sufficient information to EPA to allow the Agency to make this
determination, then the matter is handled under the appropriate medium-
specific penalty policies, which often accommodate penalty mitigation
for voluntary disclosures. The enforcement response for the vast
majority of voluntary disclosures is a Notice of Determination
(``NOD'') for cases involving no assessment of penalties. EPA retains
its discretion to assess any economic benefit that may have been
realized as a result of noncompliance. If the regulated entity has
gained significant economic benefit, or if it failed to meet all the
conditions of the applicable policy, then a civil penalty may be sought
in an administrative or judicial action.
    Overall, the Agency's voluntary disclosure programs continue to
have positive results. The Audit and Small Business Compliance Policies
have encouraged voluntary self-policing while preserving fair and
effective enforcement and their use has been widespread. As of October
1, 2006, regulated entities and organizations have resolved actual or
potential violations at 9,255 facilities.
    Thus, the solicitation of comments on tailored incentives for new
owners does not signal any intention to shift course regarding the
Agency's position on self-policing and voluntary disclosures, but
instead represents an attempt to enhance implementation of the Audit
Policy, and encourage its increased use in the new owner context.
    As mentioned in the Introduction, EPA's interest in exploring this
approach stems in part from recent experiences in the Agency's current
implementation of the Audit Policy. In the last few years, EPA has
entered into corporate auditing agreements with several companies
following a merger or acquisition valued at over $1 billion. These
corporate auditing agreements provided a unique opportunity for
companies to use self-disclosures to make a ``clean start'' with regard
to environmental compliance. The Agency recognizes that taking steps to
further encourage audit agreements in this context could offer the
potential to garner significant environmental benefit.
3. How the Audit Policy Currently Applies to New Owners
    On April 30, 2007, EPA issued the ``Audit Policy: Frequently Asked
Questions (2007)'' which recognizes that owners of newly acquired
facilities are uniquely situated to examine and improve performance at
newly acquired facilities. Specifically, the 2007 Frequently Asked
Questions provides that:
     New owners may be eligible for penalty mitigation under
the Audit Policy for violations at newly acquired facilities which are
discovered as part of a compliance examination agreed to be undertaken
prior to the 1st annual certification under Title V of the Clean Air
Act, or which are disclosed before that time.
    Generally, Clean Air Act (CAA) violations discovered during
activities supporting Title V certification requirements are not
eligible for penalty mitigation under the Policy. Condition 2 of the
Audit Policy requires that disclosed violations must not be discovered
through a legally mandated monitoring or sampling requirement
prescribed by statute or regulation; therefore, examination of CAA
compliance accompanying a Title V annual certification is not
voluntary.\2\ However, EPA wants to encourage new owners to examine
facility operations to determine compliance, correct violations, and
upgrade deficient equipment and practices. Thus, for new owners that in
good faith undertake such efforts and inform the Agency of such
actions, either by disclosure in writing or entry into an audit
agreement with EPA prior to submission of the facility's first annual
Title V certification under new ownership, the violations disclosed
would be considered voluntarily discovered for purposes of the Audit
Policy.
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    \2\ Under the regulations governing CAA Title V permit
applications and annual compliance certifications, any application,
form, report or compliance certification is required to contain a
certification by a responsible official of the truth, accuracy and
completeness of information contained in such documents. The
regulations further provide that ``[t]his certification and any
other certification required under this part shall state that, based
on information and belief formed after reasonable inquiry, the
statements and information in the document are true, accurate, and
complete.'' 40 CFR 70.5(d).
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    The 2007 Frequently Asked Questions also provides that:
     New owners may be eligible for penalty mitigation under
the Audit Policy for violations at newly acquired facilities
irrespective of the disclosing entity's compliance history at other
facilities.
    EPA's primary interest is to encourage owners of newly acquired
facilities to undertake a comprehensive examination of and improvements
to a facility's environmental compliance and its compliance management
systems. Notwithstanding a new owner's history of violations at its
other facilities, if its efforts to examine and improve upon an
acquired facility's environmental operations are thorough and are
likely to result in improved compliance, EPA's intent is to encourage
such examinations. The Audit Policy: Frequently Asked Questions (2007)
can be found on the Internet at http://www.epa.gov/compliance/incentives/auditing/auditpolicy.html
.

C. Role of Benefit Recapture in the Auditing Context

    The imposition of civil penalties that recapture the economic
benefit of noncompliance is the cornerstone of the EPA's civil penalty
program. Benefit recapture was adopted in 1984, and it has served the
Agency and the public well. Benefit recapture has also been a part of
the Audit Policy since it was first issued, on the premise that, even
in self-audit and disclosure situations, penalties should not be
reduced below the level necessary to recapture economic benefit when a
violator has achieved an economic advantage over its complying
competitors. Accordingly, the Audit Policy provides that EPA reserves
the right to assess any economic benefit which may have been realized
as a result of noncompliance, even where the entity meets all other
Audit Policy conditions. The Audit Policy further provides that the
Agency may also waive the economic benefit component of the penalty
where the Agency determines that the economic benefit is insignificant
(65 FR 19620).
    Violators obtain an economic benefit from violating the law by
delaying compliance, avoiding compliance or obtaining an unfair
competitive advantage. When violators delay compliance, they have the
use of the money that should have been spent on compliance to put into
profit-making investments. Put simply, violators ``gain'' the interest
on the amount of money that should have been invested in pollution
control equipment. A

typical example is where a factory delays installation of a required
waste water treatment facility. If the waste water treatment facility
costs $1,000,000 to install, and the violator waits three years past
the required date to comply, the violator has saved about $236,000 by
delaying compliance.\3\
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    \3\ This number was generated by the current version of the BEN
computer model using the following assumptions: (1) The violator was
in the average maximum tax bracket; (2) the violator's cost of money
(i.e., the discount/compound rate) was 7.9%; and (3) inflation was
based on the Plant Cost Index published in Chemical Engineering
magazine. The BEN computer model can be found at http://www.epa.gov/compliance/civil/econmodels/index.html
.

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    A second type of economic benefit is derived when a violator not
only delays but avoids the costs it would have incurred if it had
complied in a timely manner. A typical example would be where a factory
avoids the operation and maintenance costs for the above-mentioned
waste water treatment plant for the three years the polluter was out of
compliance. If the facility's annual operation and maintenance costs
are $100,000, then the violator probably saved about $200,000 by
avoiding the operation and maintenance costs for three years (again
assuming the violator is in the top tax bracket).
    The third type of economic benefit is derived from the violator
obtaining an unfair competitive advantage. For example, where a
violator is selling banned products (e.g., DDT), any money made from
the sale of this banned pesticide would be illegal.\4\
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    \4\ For a more detailed discussion of how economic benefit is
created, see Federal Register Notice of August 25, 2005, entitled
``Calculation of the Economic Benefit of Noncompliance in EPA's
Civil Penalty Enforcement Cases'' (70 FR 50326).
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D. Why is EPA Currently Considering Tailoring Incentives for Audit
Policy Disclosures for New Owners of Regulated Entities?

    As previously stated, one of EPA's main goals is to secure the
prompt correction of environmental violations and achieve significant
improvements to the environment as expeditiously as possible. A number
of factors, including the Agency's recent experience with corporate
auditing agreements following large mergers and acquisitions, have
highlighted the promising opportunity presented by encouraging new
owners of regulated facilities to discover, disclose, correct, and
prevent the recurrence of environmental violations.
    It is reasonable to surmise that new owners may be particularly
well-situated and highly motivated to focus on and invest in making a
``clean start'' for their new facilities and thus may be willing to
conduct thorough self-audits of their new facilities, disclose any
violations found, promptly correct the violations, and make the
significant improvements that will enhance compliance going forward. If
former owners were not timely about a facility's compliance
obligations, the new owners may want to make a clean break with the
past and get their newly acquired facilities into compliance promptly.
It is possible that new owners may see the benefits of quickly
assessing and working to limit their company's liability, and a firm
with a widely-respected compliance record may want to ensure that any
new acquisition develops a similarly positive record. Although some
anecdotal accounts suggest that, in recent years, new owners have often
had to make purchasing decisions based upon more limited information
about environmental compliance issues than may have been available in
the past, there has likely been at least some opportunity for pre-
acquisition due diligence review. Even somewhat limited due diligence
findings could help trigger a new owner's interest in more
comprehensively assessing the facility's environmental status and
exposure. New facility managers may also have access to new infusions
of capital, which could enable the sort of improvements that yield
significant benefit to the environment.
    The Agency recognizes, however, that certain disincentives may
stand in the way of new owners who are interested taking advantage of
the Audit Policy. New owners may still have to pay substantial civil
penalties under the Audit Policy, as only the gravity portion of the
penalty can currently be mitigated. It stands to reason that new owners
may be uncomfortable about calling EPA's attention to compliance issues
at their newly acquired facilities when they themselves may not be
fully aware of all the compliance issues presented. Particularly when
many and/or complex facilities are involved, it may indeed be difficult
for new owners to have a reasonable idea of the full spectrum of
compliance issues.
    In addition, the Agency's experience with implementing the Audit
Policy, especially with regard to corporate auditing agreements,
suggests that one of the major reasons a company may be hesitant to
self-audit and disclose under the Audit Policy is uncertainty about how
the Agency will treat such self-disclosures. One of the Agency's
current goals is to provide greater overall certainty and consistency
in the Audit Policy's implementation, and the recently-issued Audit
Policy: Frequently Asked Questions (2007) should help to resolve such
concerns generally. Nevertheless, there is likely still some hesitation
on the part of new owners to self-disclose violations, because they
worry about exactly how such disclosures will be handled by the Agency.
    Encouraging new owners with tailored incentives that help address
some of their concerns or alleviate some of their costs, in the context
of a well-defined program that provides greater certainty about the
handling of disclosures, may make the difference in their willingness
to come forward and to commit to improving their environmental
compliance and reducing their environmental footprint. There is a
strong equitable argument that a new owner should not be penalized for
economic benefit relating to violations that arose when a facility was
not under the new owner's control, if that new owner is willing to
promptly address violations and make changes to ensure the facility
stays in compliance in the future. The Agency is also interested in
exploring the idea of tailored incentives because it may present an
opportunity to enhance EPA's efforts to effectively utilize scarce
government resources, by securing high quality environmental
improvements and achieving the most significant environmental benefit
more quickly than might otherwise occur. Nevertheless, the Agency is
also aware that such incentives may have unintended adverse
consequences with respect to, for example, discouraging appropriate due
diligence, timely compliance and a level playing field, or other
negative effects, and EPA intends to consider the potential for such
negative results as well.

E. Objectives of Any Potential Pilot Program

    If, after review and consideration of all comments on this concept
and on any draft incentive policy, the Agency decides it makes sense to
test the approach of tailoring incentives to encourage new owners to
utilize the Audit Policy, EPA would then develop a pilot program. Such
a pilot program would be evaluated after three years and would be
designed with four main objectives in mind:
    1. The program should increase the number of self-audits and
disclosures that yield significant environmental benefits.
    2. The program should be transparent and straightforward. There
should be clarity about the program's goals and how the Agency will
handle those firms that self-audit and disclose violations, and the
program should have sufficient

safeguards to ensure that only bona-fide new owners participate.
    3. The program should be efficient to administer. EPA must develop
a program that can be effective with the limited resources available to
administer it. For instance, EPA does not envision analyzing the
various financial details of each merger or acquisition.
    4. The program should also have minimal transaction costs for the
regulated entities participating in the program. While the compliance
costs for the firms participating may be substantial, the actual
participation in the program should be cost-effective.

II. Issues

    The Agency is seeking comment limited to: (1) Whether EPA should
offer tailored incentives to encourage new owners of regulated entities
to discover, disclose, correct and prevent environmental violations;
(2) how should the Agency determine who is a new owner; (3) what
incentives should the Agency consider offering in order to encourage
new owners to self-audit and disclose; and (4) if such tailored
incentives are offered, what measures should the Agency use in
determining whether and to what extent self-audits and disclosures from
new owners are achieving significant improvements to the environment.

A. Should the Agency Offer Tailored Incentives to Encourage New Owners
of Regulated Entities to Self-Audit and Disclose Violations?

    Are tailored incentives needed and/or appropriate to encourage
self-audits and disclosures by new owners of regulated entities? Do the
circumstances of new ownership warrant special consideration or
handling, if the new owner was not responsible for creating a violation
and there exists potentially significant environmental benefit that
could result from new owners' disclosures and correction of violations?
Or, does the Audit Policy as currently implemented already offer
sufficient incentives to induce new owners to undertake self-audits and
disclosures?
1. Due Diligence in Mergers and Acquisitions
    Anecdotal accounts suggest that, in today's merger and acquisition
market, acquiring firms often have to make decisions about a target
acquisition under tight deadlines and with relatively minimal
information about an entity's environmental compliance status or
problems. These accounts indicate that the traditional paradigm of
assuming that due diligence review will yield full knowledge to the
purchaser about any potential acquisition may not be accurate in many
current mergers and acquisitions. EPA suspects that the amount of
environmental compliance due diligence varies greatly depending on the
industrial sector involved, or on whether a certain target facility's
or company's environmental compliance is likely to present an important
or material issue (e.g., environmental compliance would be more germane
to the purchase of a chemical company than of a financial services
firm). EPA seeks comment on the extent to which pre-acquisition due
diligence reviews reveal environmental noncompliance (as opposed to
environmental contamination and remedial liability).
    Providing tailored incentives to self-audit and disclose could
potentially improve environmental compliance in these situations by
encouraging in-depth auditing after purchase. On the other hand,
providing such incentives could cause sellers to further delay or avoid
compliance (i.e., a firm might be tempted to sell off a unit to another
business in its noncompliant state rather than bring that unit into
compliance), or could have the unintended effect of encouraging buyers
to perform inadequate due diligence. EPA seeks comment on whether it
would be appropriate to require that new owners have performed a
certain level of pre-acquisition due diligence to qualify for tailored
incentives, and if so, what that level should be? The Agency also seeks
comment on the potential effects on environmental compliance and on due
diligence reviews that might result from offering tailored incentives
for new owners.
2. Purchase Price Calculation
    If, as the anecdotal reports mentioned above would indicate, the
due diligence that potential buyers perform may have substantial gaps
with regard to information about environmental compliance issues, what
is the effect on acquisition negotiations? If an acquiring company had
perfect information, presumably it would adjust its offered purchase
price to account for any anticipated environmental liabilities
associated with the target firm. But, without good information, the
buyer's offer may not reflect adjustments for the cost of environmental
noncompliance. EPA seeks comment on the extent to which environmental
noncompliance liabilities (as distinguished from environmental
remediation liabilities) are reflected in purchase price, and whether
tailored incentives should take this into account.
3. Indemnification Agreements Between Purchaser and Seller
    The Agency is aware that, in acquisition situations, sellers may
indemnify purchasers across a broad range of issues, including
environmental liability. If a selling firm has indemnified the
purchaser for violations which are ultimately disclosed by the new
owner, are tailored incentives to self-report needed at all? On the
other hand, the mere existence of an indemnification agreement does not
insulate the purchaser from liability. Given the Agency's interest in
encouraging appropriate accountability and buyer/seller agreements on
environmental compliance issues, how should EPA take indemnification
agreements into account in designing any tailored incentives? Should
the existence or terms of an indemnification agreement have any bearing
on a new owner's eligibility for tailored incentives and, if so, how?
The Agency seeks comment on all the questions above.
4. Other Requirements for Incentives
    Should the Agency consider other eligibility criteria or
participation requirements if a program to offer tailored incentives is
developed?

B. What Constitutes a ``New Owner'' for Purposes of Being Offered
Tailored Incentives under the Audit Policy?

    If EPA develops a pilot program offering incentives to new owners,
the Agency's goal would be to ensure that only bona-fide new owners can
participate. There should be no possibility that a firm could evade
significant environmental liabilities by making superficial changes
designed to make it appear as if the regulated entity has a new owner.
The Agency believes that, in the context of eligibility for tailored
incentives, only ``arm's length'' transactions can produce ``new
owners.''
    However, the Agency does not have the resources necessary to delve
into complex corporate structures and histories to make determinations
about the authenticity of new ownership in the context of such Audit
Policy self-disclosures. The Agency seeks comment on a clear,
straightforward and easily administered approach to determining ``new
ownership'' and eligibility for tailored incentives, and on the
specific questions posed below.
1. What should a company need to provide to demonstrate to the Agency
that it is a bona-fide ``new owner?''
    What should the standard be, to demonstrate ``new ownership'' in
this

context? Should the Agency require each company to self-certify to the
government that it is indeed a bona-fide new owner, and eligible for
tailored incentives? If a self-certification is appropriate in this
situation, what should it contain? Should other proof be offered along
with the self-certification?
2. How long after an acquisition is an owner still ``new'' for the
purpose of being offered tailored incentives?
    The Agency is seeking a clear approach to use in making such
determinations. While EPA wants to encourage new owners to avail
themselves of this process, there must be a time limit for the new
owners to address environmental violations that began prior to their
assuming ownership. Otherwise, the Audit Policy's goal of encouraging
regulated entities to self-audit and promptly correct noncompliance
could be undermined.
3. How should the Agency treat different acquisition transactions?
    Should the Agency make any distinctions between acquisitions and
mergers? How should EPA handle disclosures by reorganized companies
that emerge from Chapter 11 bankruptcy? Should companies in which the
controlling interest is purchased by a new firm with no plans to
participate in management or operations be eligible for incentives? How
should the Agency treat companies that are purchased by their
employees, who were employed by the company when noncompliance began?

C. What Incentives Should the Agency Consider to Encourage New Owners
to Self-Disclose?

    EPA is also inviting comment on what tailored incentives might be
appropriate to encourage self-auditing and disclosures from new owners.
EPA has identified three major potential incentives: (1) Reducing civil
penalties beyond what the current Audit Policy provides, by reducing
any economic benefit portion of the penalty; (2) allowing Audit Policy
consideration of violations which would otherwise be ineligible,
because their discovery is legally mandated and thus not discovered
voluntarily; and (3) providing recognition from the Agency to new
owners who self-audit and disclose under the Audit Policy.
    EPA is seeking comment on these three possible incentives as well
as on any alternative approaches that might be effective. Commenters
suggesting other incentives are requested to clearly describe those
incentives and how they would function in the Audit Policy context.
    In addition, there are some specific questions associated with the
three potential incentives suggested above on which EPA is seeking
comment:
1. How should economic benefit be calculated for disclosures by new
owners?
    a. When should the clock start running when calculating economic
benefit?
    The current practice is to calculate economic benefit forward from
the date a violation first occurred. This method can result in benefit
calculations so large that they serve as a disincentive to self-report,
especially in the context of certain types of statutory violations,
which may be longstanding and require multi-million dollar capital and
operating cost expenditures to remedy. Additionally, most new owners
would be averse to paying significant economic benefit amounts when
they were not in control of the facility when the violations occurred
and had little or no knowledge of them at the time of purchase. An
alternative method of calculating benefit in the new owner context
would be to commence calculating economic benefit from the date the
facility was acquired; another possibility might be to use the date the
post-acquisition audit was completed. If the latter, how long should a
new owner be given to complete the audit? Another approach might be to
give the new owner a reasonable time after acquisition to put on
controls, particularly where those controls are complex, and to
calculate benefits for delays beyond the reasonable period.
    b. Should the economic benefit calculation take into account
whether and the extent to which the seller has indemnified the buyer?
    As discussed above, in Section II.A.3.of this Notice, the Agency is
aware that, in many acquisition situations, the seller has indemnified
the new owner from liability from a whole host of issues, often
including certain environmental liabilities. The Agency seeks comment
specifically on whether such indemnification arrangements should have
any bearing on the calculation of penalties for economic benefit, as a
potential incentive.
    c. In calculating economic benefit, should the Agency allow the new
owner to offset the cost of the audit?
    Some self-audits can be expensive, particularly for large, complex
facilities. One incentive might be to offset the cost of the audit from
the economic benefit calculation. A fair, objective and efficient way
of establishing the cost of the audit would be critical to this
approach, especially when an audit has been performed by the company
itself, rather than by an outside third-party auditor.
2. Should EPA allow consideration under the Audit Policy of violations
which might otherwise be excluded, when the disclosures come from new
owners?
    As described in Section I.B.3.of this Notice, EPA's recently issued
Audit Policy: Frequently Asked Questions (2007) makes new owners
eligible for Audit Policy penalty mitigation for violations at newly
acquired facilities, when the violations are discovered as part of a
compliance examination agreed to be undertaken prior to the first
annual certification under Title V of the Clean Air Act, or are
disclosed to EPA before that time. An additional suggested incentive is
to allow consideration under the Audit Policy of certain other
violations (e.g., Risk Management Program (RMP) under CAA 112(r)(7))
which may otherwise be ineligible for Audit Policy penalty mitigation.
As noted above, Condition 2 of the Audit Policy requires that disclosed
violations must not be discovered through a legally mandated monitoring
or sampling requirement prescribed by statute or regulation. Therefore,
for example, examination pursuant to a RMP Triennial Audit would not
normally be considered voluntary. Since EPA wants to encourage new
owners to examine compliance and operations at their newly-acquired
facilities, correct violations and upgrade deficient equipment and
practices, should new owners that in good faith undertake a RMP
triennial Audit and inform the Agency of violations, which existed
prior to acquisition and are discovered through the audit, be eligible
for Audit Policy consideration? Are there other similar categories of
violations disclosed by new owners that should be eligible for Audit
Policy consideration?
3. Should the Agency provide recognition to new owners who self-audit
and disclose under the Audit Policy?
    Would positive recognition by the Agency, commending a new owner's
willingness to voluntarily audit and disclose, encourage a company to
undertake such actions? One suggestion has been to create and publicize
a list that recognizes companies that have stepped forward to examine
compliance and operations at their newly acquired facilities, correct
violations and upgrade

deficient equipment and practices. What sort of recognition, if any,
would be most desirable?

D. Measures of Success

    If the Agency decides to develop a policy for tailored incentives
for new owners, EPA intends to develop a three-year pilot program to
test the effectiveness of such incentives. In order to objectively,
effectively and promptly evaluate the pilot program and this approach,
EPA must have already identified clearly measurable outcomes and
efficient assessment methodologies. The main goal of this program, and
the most important measure of success, would be to show that compliance
with environmental laws and regulations has improved, and that
significant environmental benefit has been attained. However, there are
different approaches for determining how well these goals have been
met.
    What measures of success should the Agency adopt for the evaluation
of a pilot program? Important outcomes to consider could be the number
of disclosures made under the pilot program, the significance of the
violations involved, and the significance of the pollutant reductions
that can be attributed to or associated with these disclosures.
Transparency of the program, efficiency in administration, and low
transaction costs are also issues to be considered in evaluating the
tailored incentive approach. EPA is seeking comment on any potential
measures, and on the methodologies necessary to accurately measure
them.

III. Public Process

    As part of EPA's effort to obtain input on whether to offer
tailored incentives for new owners self-disclosing under the Audit
Policy, the Agency is planning to hold two public comment sessions. At
those two meetings, interested parties may attend and provide oral and
written comments on the issues. The first meeting is scheduled for
Washington, DC at the J.W. Marriott Hotel, 1331 Pennsylvania Ave., NW.,
on June 12, 2007. The second one is scheduled for San Francisco at the
Palace Hotel, 2 New Montgomery St., on June 20, 2007. Both meetings
will begin at 10 a.m. and end at 4 p.m.
    The Agency is especially interested in comments relating to the
issues specified in this Notice. After the comment period closes, the
Agency plans to review and consider all comments. If EPA decides to
develop a pilot program offering tailored incentives to new owners
beyond those currently available under the Audit Policy, the Agency
would then publish a second Federal Register notice to seek comment on
such a proposed pilot program. After a second round of public comment,
the Agency would publish in the Federal Register: The final description
of the pilot program; an announcement of its start date; and a
description of how its success in achieving increased self-auditing and
disclosure and significant improvement to the environment will be
evaluated. EPA encourages parties of all interests, including State and
local government, industry, not-for-profit organizations,
municipalities, public interest groups and private citizens to comment,
so that the Agency can hear from as broad a spectrum as possible.

IV. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR Part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the Notice; Request for Comments by docket number
and other identifying information (subject heading, Federal Register
date and page number).
     Follow directions--The Agency may ask you to respond to
specific questions.
     Explain why you agree or disagree; suggest alternatives
and language.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If possible, provide any pertinent information about the
context for your comments (e.g., the size and type of acquisition
transaction you have in mind).
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible.
     Submit your comments on time.

    Dated: April 30, 2007.
Granta Y. Nakayama,
Assistant Administrator, Office of Enforcement and Compliance
Assurance.
[FR Doc. E7-9197 Filed 5-11-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Rules and Regulations]
[Pages 31723-31724]
[FR Doc No: 2019-14222]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0515]
RIN 1625-AA00

Safety Zone; Ohio River, Miles 67.5-68.5, Steubenville, OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Ohio River from Mile 67.5 to Mile 68.5. The
safety zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by a land-based fireworks
display. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by Captain of the Port Marine Safety
Unit Pittsburgh.

DATES: This rule is effective from 9 p.m. through 11:30 p.m. on July 4,
2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0515 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST2 Charles Morris, Marine Safety Unit Pittsburgh, U.S.
Coast Guard, at telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. The safety zones
must be established by July 4, 2019 and we lack sufficient time to
provide a reasonable comment period and then consider those comments
before issuing this rule. The NPRM process would delay the
establishment of the safety zones until after the scheduled date.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because this action
is necessary to ensure the safety of vessels and persons during the
fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Marine
Safety Unit Pittsburgh (COTP) has determined that a safety zone is
needed to protect personnel, vessels, and the marine environment from
potential hazards created from a land-based firework display.

IV. Discussion of the Rule

    This rule establishes a safety zone on July 4, 2019, from 9 p.m.
through 11:30 p.m. The safety zone will cover all navigable waters on
the Ohio River from Mile 67.5 to Mile 68.5. The duration of the safety
zone is intended to protect personnel, vessels, and the marine
environment from potential hazards created by a land based firework
display.
    No vessel or person is permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard (USCG) assigned to units under the operational
control of the COTP. To seek permission to enter, contact the COTP or a
designated representative via VHF-FM channel 16, or through Marine
Safety Unit Pittsburgh at<PHONE_NUMBER>. Persons and vessels permitted
to enter the safety zone must comply with all lawful orders or
directions issued by the COTP or designated representative. The COTP or
a designated representative will inform the public of the effective
period for the safety zone as well as any changes in the dates and
times of enforcement through Local Notice to Mariners (LNMs), Broadcast
Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins
(MSIBs), as appropriate.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the temporary safety zone. This safety zone
impacts only a one-mile stretch of the Ohio River for a short amount of
time of 2 and one half hours on one evening. Vessel traffic will be
informed about the safety zone through local notices to mariners.
Moreover, the Coast Guard will issue LNMs, MSIBs, and BNMs via VHF-FM
marine channel 16 about the zone and the rule allows vessels to seek
permission from the COTP to transit the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting two and one half
hours that will prohibit entry on the Ohio River from mile 67.5 to mile
68.5, during the land-based firework event. It is categorically
excluded from further review under paragraph L60(A) in Table 3-1 of
U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1.
A Record of Environmental Consideration supporting this determination
is available in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0515 to read as follows:

Sec.  165.T08-0515  Safety Zone; Ohio River, Miles 67.5-68.5,
Steubenville, OH.

    (a) L/ocation. The following area is a temporary safety zone: All
navigable waters of the Ohio River from Mile 67.5 to Mile 68.5.
    (b) Effective period. This section is effective from 9 p.m. through
11:30 p.m. on July 4, 2019.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of persons and vessels into this zone is prohibited
unless authorized by the Captain of the Port Marine Safety Unit
Pittsburgh (COTP) or a designated representative.
    (2) Persons or vessels requiring entry into or passage through the
zone must request permission from the COTP or a designated
representative. The COTP's representative may be contacted at 412-670-
4288.
    (3) All persons and vessels shall comply with the instructions of
the COTP or a designated representative. Designated COTP
representatives include United States Coast Guard commissioned,
warrant, and petty officer.
    (d) Information broadcasts. The Captain COTP or a designated
representative will inform the public through Local Notice to Mariners
(LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety
Information Bulletins (MSIBs), as appropriate.

S. Miros,
Lieutenant Commander, U.S. Coast Guard, Acting Captain of the Port
Marine Safety Unit Pittsburgh.
[FR Doc. 2019-14222 Filed 7-2-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Rules and Regulations]
[Pages 13553-13554]
[FR Doc No: 2017-04939]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-1123]

Medical Devices; Neurological Devices, Classification of the
Vibratory Counter-Stimulation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
vibratory counter-stimulation device into class II (special controls).
The special controls that will apply to the device are identified in
this order and will be part of the codified language for the vibratory
counter-stimulation device's classification. The Agency is classifying
the device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective March 14, 2017. The classification was
applicable on December 18, 2013.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD 20993-0002, 301-
796-6476<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a predicate device that does
not require premarket approval. The Agency determines whether new
devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) of the FD&C Act and then a request for
classification under the first procedure, the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on June 14, 2011, classifying the Symphony Device into class III,
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II.
    On July 13, 2011, Sensory Medical, Inc. submitted a request for
classification of the Symphony Device under section 513(f)(2) of the
FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on December 18, 2013, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 882.5895.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a vibratory
counter-stimulation device will need to comply with the special
controls named in this final order. A De Novo classification decreases
regulatory burdens. When FDA classifies a device type as class I or II
via the De Novo pathway, other manufacturers do not have to submit a De
Novo request or PMA in order to market the same type of device, unless
the device has a new intended use or technological characteristics that
raise different questions of safety or effectiveness. Instead,
manufacturers can use the less burdensome pathway of 510(k), when
necessary, to market their device, and the device that was the subject
of the original De Novo

classification can serve as a predicate device for additional 510(k)s
from other manufacturers.
    The device is assigned the generic name vibratory counter-
stimulation device, and it is identified as a prescription device that
provides electrically powered mechanical vibration to improve the
quality of sleep in patients with primary Restless Legs Syndrome.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Vibratory Counter-Stimulation Device Risks and Mitigation
                                Measures
------------------------------------------------------------------------
              Identified risks                    Mitigation measure
------------------------------------------------------------------------
Pain, discomfort, worsening of Restless      Non-clinical testing,
 Legs Syndrome symptoms.                      Software testing,
                                              Labeling.
Electrical shock...........................  Electrical safety testing,
                                              Labeling.
Burns......................................  Electrical and thermal
                                              safety testing, Labeling.
Adverse skin reactions.....................  Biocompatibility
                                              assessment, Labeling.
Interference with other medical devices....  Electromagnetic
                                              compatibility testing,
                                              Labeling.
------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
    Vibratory counter-stimulation devices are not safe for use except
under the supervision of a practitioner licensed by law to direct the
use of the device. As such, the device is a prescription device and
must satisfy prescription labeling requirements (see 21 CFR 801.109,
Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that the device is
not exempt from the premarket notification requirements of the FD&C
Act. Persons who intend to market this type of device must submit a
premarket notification (510(k)), prior to marketing the device, which
contains information on the vibratory counter-stimulation device they
intend to market.

II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling have been
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  882.5895 to subpart F to read as follows:

Sec.  882.5895   Vibratory counter-stimulation device.

    (a) Identification. A vibratory counter-stimulation device is a
prescription device that provides electrically powered mechanical
vibration to improve the quality of sleep in patients with primary
Restless Legs Syndrome.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Appropriate analysis/testing must demonstrate electromagnetic
compatibility (EMC), electrical safety, and thermal safety.
    (2) If the device contains software or firmware, appropriate
verification, validation, and hazard analysis must be performed.
    (3) The elements of the device that contact the patient must be
assessed to be biocompatible.
    (4) Non-clinical testing data (including vibration frequency,
amplitude, and acceleration) must demonstrate that the device performs
as intended under anticipated conditions of use.
    (5) Labeling must include:
    (i) Specific information pertinent to use of the device by the
intended patient population and the treatment regimen;
    (ii) Warning to only use the device on normal, intact, clean,
healthy skin;
    (iii) Warning to not use the device if the user has leg skin
disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;
    (iv) Warning to discontinue use if Restless Leg Syndrome symptoms
worsen; and
    (v) Instructions for end users to contact the device manufacturer
and MedWatch in case they experience any adverse events when using this
device.

    Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04939 Filed 3-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Notices]
[Pages 8251-8252]
[FR Doc No: 2012-3401]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14355-000]

 John B. Crockett; Notice of Preliminary Permit Application
Accepted for Filingand Soliciting Comments, Motions to Intervene, and
Competing Applications

    On January 20, 2012, John B. Crockett filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the East Fork Ditch
Hydroelectric Project (East Fork Ditch project) to be located on East
Fork Ditch in the vicinity of Council, in Adams County, Idaho. The sole
purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project will consist of the following: (1) A concrete
intake structure on the East Fork Ditch with a trash rack and steel
stand pipe; (2) 11,150-foot-long, 24-inch-diameter penstock from the
East Fork Ditch

intake structure; (3) a 28-foot by 32-foot concrete powerhouse
containing one turbine/generator unit with a capacity of 1.35
megawatts; (4) an approximately 1,900-foot-long, 69-kV transmission
line which will tie into an undetermined interconnection; and (5)
appurtenant facilities. The estimated annual generation of the East
Fork Ditch project would be 4.0 gigawatt-hours.
    Applicant Contact: John B. Crockett, 3296 Snowflake Way, Boise, ID
83706; phone:<PHONE_NUMBER>.
    FERC Contact: Ryan Hansen<PHONE_NUMBER> or<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14355-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: February 8, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-3401 Filed 2-13-12; 8:45 am]
BILLING CODE 6717-01-P


From: < Johnston. Carey@ epamail. epa. gov> To: " Schwartz, Jerry" < Jerry_ Schwartz@ afandpa. org> Date: 1/ 9/ 2004 11: 43: 24 AM Subject: toxics loading information and PCS locational information on TimberProducts and P& P Phase II facilities Dear Jerry:

In our phone conversation a few days ago you offered to see if you could help fill in missing information for EPA's PCS database. Attached are XL spreadsheets with toxics loading information and PCS locational information on Timber Products and P& P Phase II facilities. I understand that you may not be able to help fill in this missing information, however, I appreciate your initial offer to check and see what you can do. As we discussed, EPA needs more and better data to improve its analyses.

Sincerely,

Carey A. Johnston, P. E. U. S. EPA, Office of Water ph: ( 202) 566 1014 fx: ( 202) 566 1053 johnston. carey@ epa. gov ( See attached file: timber & pulp& paper phase II toxic loadings. xls)( See attached file: timber & pulp& paper phase II PCS locational data. xls)

CC: < Wall. Tom@ epamail. epa. gov>, < Siddiqui. Ahmar@ epamail. epa. gov>, < Matuszko. Jan@ epamail. epa. gov>, < Kugler. Tracy@ epamail. epa. gov>, < Hair. David@ epamail. epa. gov>, Betsy Bicknell < Betsy. Bicknell@ erg. com>, Deborah Bartram < Deborah. Bartram@ erg. com>, < Anderson. Donaldf@ epamail. epa. gov>


10718 Federal Register / Vol. 68, No. 44 / Thursday, March 6, 2003 / Notices maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners or operators of coal preparation plants which process more than 200 tons of coal per day. Estimated Number of Respondents: 616. Frequency of Response: Semiannually. Estimated Total Annual Hour Burden: 17,162 hours. Estimated Total Capital and Operations & Maintenance ( O & M) Annual Costs: $ 21,700 which includes $ 0 annualized capital/ startup costs and $ 21,700 annual O& M costs. Changes in the Estimates: There is increase of 1,699 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to more accurate accounting of existing sources subject to NSPS Subpart Y and an adjustment in the reporting frequency.

Dated: February 25, 2003 Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 03   5312 Filed 3   5   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OECA   2002   0017; FRL   7458   1]

Agency Information Collection Activities: Submission for OMB Review and Approval; Comment Request; NSPS for Industrial Commercial Institutional Steam Generating Units ( 40 CFR Part 60, Subpart Db), ICR No. 1088.10, OMB No. 2060   0072 AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: NSPS for Industrial Commercial Institutional Steam Generating Units ( 40 CFR part 60, subpart Db), OMB Control Number 2060   0072, EPA ICR No. 1088.10. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments must be submitted on or before April 7, 2003. ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dan Chadwick, Compliance Assessment and Media Programs Division, Office of Compliance, Mail Code 2223A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number ( 202) 564   7054; fax number ( 202) 564   0050; email address chadwick. dan@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA   2002   0017, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566   1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e mail to docket. oeca@ epa. gov, or by mail to EPA Docket Center, Environmental Protection Agency, Mailcode: 2223A, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: NSPS for Industrial Commercial Institutional Steam Generating Units ( 40 CFR part 60, subpart Db), OMB Control Number 2060   0072, EPA ICR Number 1088.10. This is a request to renew an existing approved collection that is scheduled to expire on February 28, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: Owners or operators of steam generating units subject to Subpart Db must make one time only notifications of construction/ reconstruction, anticipated and actual startup, initial performance test, physical or operational changes, and demonstration of a continuous monitoring system. They must also submit reports on initial performance test results, monitoring results, and excess emissions. Records must be maintained of startups, shutdowns, malfunctions, and periods when the continuous monitoring system is inoperative, and of various fuel combustion and pollutant emission parameters. The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved. The monitoring and excess emissions reports are used for problem identification, as a VerDate Jan< 31> 2003 15: 33 Mar 05, 2003 Jkt 200001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06MRN1. SGM 06MRN1 10719 Federal Register / Vol. 68, No. 44 / Thursday, March 6, 2003 / Notices check on source operation and maintenance, and for compliance determinations. The information collected from recordkeeping and reporting requirements are used for targeting inspections, and for other uses in compliance and enforcement programs. The frequency of electronic reporting is quarterly. Otherwise, reporting frequency is semiannual. Responses to this information collection are deemed to be mandatory, per section 114( a) of the Clean Air Act. The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, part 2, subpart B   Confidentiality of Business Information ( see 40 CFR part 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 200 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners or operators of fossil fuel fired steam generating units subject to Subpart Db. Estimated Number of Respondents: 1,230. Frequency of Response: Semiannually Quarterly for electronic. Estimated Total Annual Hour Burden: 591,389. Estimated Total Annual Cost: $ 59,384,435, includes $ 9,000,000 annualized capital and $ 17,775,000 O& M costs. Changes in the Estimates: There is an increase of 16,356 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to an increase in the size of the regulated universe.

Dated: February 26, 2003. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 03   5313 Filed 3   5   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OECA   2003   0001; FRL   7458   2]

Agency Information Collection Activities; Submission for EPA ICR No. 1847.03, OMB No. 2060   0390 to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Federal Plan Recordkeeping and Reporting Requirements for Large Municipal Waste Combustors Constructed on or Before September 20, 1994 ( 40 CFR part 62, subpart FFF). This ICR describes the nature of the information collection and its estimated burden and cost burden and cost. DATES: Additional comments may be submitted on or before April 7, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Jonathan Binder, Compliance Assistance and Sector Programs Division, Office of Compliance, Mail Code 2224A, 202   564   2516 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; fax number: 202   564   0009; e mail address: binder. jonathan@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID Number OECA   2003   0001, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( ECDIC) in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding federal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the Enforcement and Compliance Docket and Information Center ( ECDIC) is ( 202) 566   1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket identification number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e mail to docket. oeca@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information ( CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as VerDate Jan< 31> 2003 15: 33 Mar 05, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06MRN1. SGM 06MRN1


May 30   June 2, 2003   Episode ° Plots provide ozone concentration and wind vectors ID Description AP Apex JN Jean JO Joe Neal MQ Mesquite PL Hendersen PV Palo Verde School LV Las Vegas Airport NE Nellis Air Force S1 Reid Gardner 1 S3 Reid Gardner 3 CAL CalWash 3 Monitoring Stations


[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Rules and Regulations]
[Page 14534]
[FR Doc No: 2021-05623]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No.<PHONE_NUMBER>]
RIN 0694-AI38

Expansion of Certain End-Use and End-User Controls and Controls
on Specific Activities of U.S. Persons; Correction

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Interim final rule; correction.

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

SUMMARY: The Bureau of Industry and Security (BIS), Department of
Commerce, is correcting an interim final rule, ``Expansion of Certain
End-Use and End-User Controls and Controls on Specific Activities of
U.S. Persons,'' that appeared in the Federal Register of January 15,
2021 (hereinafter referred to as the January 15 rule) by revising an
incorrect instruction that would have resulted in the inadvertent
deletion of two subparagraphs of the Export Administration Regulations'
(EAR) restrictions on certain rocket systems and unmanned aerial
vehicles.

DATES: Effective date: March 16, 2021.

FOR FURTHER INFORMATION CONTACT: Philip Johnson, Senior Advisor, Export
Enforcement, Bureau of Industry and Security, Phone:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On January 15, 2021, BIS published an interim final rule expanding
certain end-use and end-user controls and controls on specific
activities of U.S. persons (86 FR 4865) (hereinafter the January 15
rule). Due to an instruction error, which directed the revision of
paragraph (a)(3) of Sec.  744.3 of the EAR, rather than only the
introductory text of that paragraph, upon its effective date, the
January 15 rule would have resulted in the inadvertent deletion of
Sec.  744.3(a)(3)(i) and (ii) of the EAR, which describe the license
requirements that apply when an exporter, reexporter, or transferor
cannot determine the range capabilities of a rocket system or unmanned
aerial vehicle (UAV) in certain countries of missile technology concern
(Country Group D:4) (see Supplement No. 1 to part 740 of the EAR), or
whether such rocket system or UAV will be used in connection with the
delivery of certain weapons of mass destruction. This was a technical
error and BIS did not intend to remove the existing restrictions on
exports, reexports, and transfers (in-country) applicable to certain
rocket systems and UAVs in D:4 countries currently set forth in Sec.
744.3(a)(3)(i) and (ii) of the EAR. To remediate this error, BIS is
correcting the instruction in the January 15 rule to revise only the
introductory ``text of Sec.  744.3(a)(3), rather than the entire
paragraph.

Correction

    Accordingly, in FR Doc. 2021-00977, appearing on page 4865 in the
Federal Register of Friday, January 15, 2021, the follow correction is
made:

Sec.  744.3  [Correction]

0
1. On page 4871, first column, instruction 9 is corrected to read
``Section 744.3 is amended by revising paragraphs (a)(1) and (2), the
introductory text to paragraph (a)(3), and paragraphs (d)(2)(ii) and
(v) to read as follows:''

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2021-05623 Filed 3-15-21; 4:15 pm]
BILLING CODE 3510-33-P