[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Proposed Rules]
[Pages 44817-44825]
[FR Doc No: 2016-15791]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 164

[Docket No. USCG-2015-0926]
RIN 1625-AC27

Tankers--Automatic Pilot Systems in Waters

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to permit tankers with automatic
pilot systems that meet certain international standards to operate
using those systems in waters subject to the shipping safety fairway or
traffic separation scheme controls specified in our regulations. The
proposed amendments would remove an unnecessary regulatory restriction,
update the technical

requirements for automatic pilot systems, and promote the Coast Guard's
maritime safety and stewardship (environmental protection) missions by
enhancing maritime safety.

DATES: Comments and related material must be submitted to the online
docket via http://www.regulations.gov, or reach the Docket Management
Facility, on or before October 11, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0926 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.
    Viewing material proposed for incorporation by reference. Make
arrangements to view this material by calling the person identified in
the FOR FURTHER INFORMATION CONTACT section of this document.

FOR FURTHER INFORMATION CONTACT: For information about this document or
to view material proposed for incorporation by reference call or email
LCDR Matthew J. Walter, CG-NAV-2, U.S. Coast Guard; telephone 202-372-
1565, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation and Request for Comments
    A. Submitting Comments
    B. Viewing Comments and Documents
    C. Privacy Act
    D. Public Meeting
II. Abbreviations
III. Basis and Purpose
IV. Discussion of Proposed Rule
V. Incorporation by Reference
VI. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted or a final rule is published.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the January 17, 2008, issue of the Federal
Register (73 FR 3316).
    We are not planning to hold a public meeting but will consider
doing so if public comments indicate a meeting would be helpful. We
would issue a separate Federal Register notice to announce the date,
time, and location of such a meeting.

II. Abbreviations

BLS Bureau of Labor Statistics
COTP Captain of the Port
DHS Department of Homeland Security
E.O. Executive Order
FR Federal Register
IEC International Electrotechnical Commission
IMO International Maritime Organization
INS Integrated navigation system
LOD Letter of Deviation
OMB Office of Management and Budget
RA Regulatory Analysis
SBA Small Business Administration
Sec.  Section symbol
TSS Traffic separation scheme
U.S.C. United States Code

III. Basis and Purpose

    The legal basis for this rulemaking is provided by 46 U.S.C. 2103
and 3703. Section 2103 gives the Secretary of the department in which
the Coast Guard is operating discretionary authority to ``prescribe
regulations to carry out the provisions of'' 46 U.S.C. Subtitle II,
which includes provisions for tanker carriage of liquid bulk dangerous
cargoes. Section 3703 requires the Secretary to prescribe regulations
for the operation, equipment, and other issues relating to the carriage
of liquid bulk dangerous cargoes. In DHS Delegation No. 0170.1
(II)(70), (92.a), and (92.b), the Secretary delegated authority under
these statutes to the Coast Guard.
    The purpose of the proposed rule is to permit tankers with
automatic pilot systems (autopilots, a generic term) that meet certain
international standards to operate using those systems in waters
subject to the shipping safety fairway or traffic separation scheme
(TSS) controls specified in 33 CFR parts 166 and 167.

IV. Discussion of Proposed Rule

    The proposed rule would amend 33 CFR 164.13, relating to the
navigation of tankers underway. We promulgated Sec.  164.13 in 1993.\1\
Paragraph (d)(3) of the section prohibited a tanker's use of an
autopilot in waters subject to 33 CFR part 166 shipping safety fairway
\2\ or 33 CFR part 167 TSS \3\ controls, but made an exception for an
autopilot working in concert with an ``integrated navigation system''
(INS),\4\ as described in paragraph (e) of the section.
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    \1\ 58 FR 27633 (May 10, 1993).
    \2\ A fairway is defined by 33 CFR 166.105(a) as ``a lane or
corridor in which no artificial island or fixed structure, whether
temporary or permanent, will be permitted.'' Part 166 lists the U.S.
waters subject to fairway controls.
    \3\ A TSS is defined by 33 CFR 167.5(b) as ``a designated
routing measure which is aimed at the separation of opposing streams
of traffic by appropriate means and by the establishment of traffic
lanes.'' Part 167 lists the U.S. waters subject to TSS controls.
    \4\ ``The purpose of an integrated navigation system . . . is to
provide `added value' to the functions and information needed by the
officer in charge of the navigational watch . . . to plan, monitor
or control the progress of the ship.'' MSC.86(70) Annex 3, para. 1.
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    Immediately after we promulgated 33 CFR 164.13, we received a
public comment noting that, at the time, ``INS'' described a wide range
of shipboard systems for which there was no performance standard for
the INS' accuracy, integrity, or reliability. Therefore, before Sec.
164.13 was to take effect, we suspended paragraph (e) \5\ until such
time as we could develop the testing and methodology necessary for
certifying that an INS has satisfactory accuracy, integrity, and
reliability. The 1993 suspension was noted in an editor's note to 33
CFR 164.13.\6\ The

suspension had the effect of prohibiting the use of any autopilot in
fairway or TSS waters.
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    \5\ 58 FR 36141 (Jul. 6, 1993).
    \6\ The note was inadvertently deleted in 1996, creating some
industry confusion as to whether the suspension remained in effect.
Some tanker owners and operators proceeded to install and operate
INSs in TSS or fairway waters. The Coast Guard issued Marine Safety
Information Bulletin 10/13 (Feb. 2013) to remind owner and operators
that the suspension remained in effect. The editor's note was
restored to the CFR in 2013.
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    Section 164.13(e) provided three criteria for showing that an INS
can adequately control a tanker. The system must show that it:
    1. Can maintain a predetermined trackline with a crosstrack error
of less than 10 meters 95 percent of the time;
    2. Can provide continuous position data accurate to within 20
meters 95 percent of the time; and
    3. Has immediate override control.
    Today, Criterion 2 is easily met by any tanker with a modern global
navigation satellite system, and Criterion 3 is met by all systems now
on the market.
    Criterion 1, the ability to maintain a predetermined trackline with
high accuracy, has benefited from advances in autopilot technology
since 1993, in particular the advent of heading control systems,\7\
track control systems,\8\ or integrated navigation systems.\9\ The
International Electrotechnical Commission (IEC), a voluntary industry
consensus standards-setting body, has developed a standard for heading
and track control systems. The International Maritime Organization
(IMO) has adopted resolutions endorsing this standard and has
recommended to IMO member states that they adopt performance standards
``not inferior to'' \10\ those the IMO has adopted. We believe that
tanker autopilot systems meeting the IEC standard should be relieved of
the regulatory burden that prohibits their use in fairway and TSS
waters.
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    \7\ A heading control system, ``in conjunction with its source
of heading information, should enable a ship to keep a preset
heading with minimum operation of the ship's steering gear.'' IMO
Resolution MSC.64 (67), Annex 3, para. 2.1.
    \8\ ``Track control systems in conjunction with their sources of
position, heading and speed information are intended to keep a ship
automatically on a pre-planned track over ground under various
conditions and within the limits related to the ship's
maneuverability. A track control system may additionally include
heading control.'' IMO Resolution MSC.74(69) Annex 2, para. 1.
    \9\ ``An INS is a combination of systems that are interconnected
to increase safe and efficient navigation by suitably qualified
personnel.'' IMO Resolution MSC.86(70), Annex 3, para. 3.3. An INS
incorporates either a heading or track control system.
    \10\ IMO Resolution MSC.86(70), para. 3 (Dec. 8, 1998).
Resolution MSC.86(70) applies to INS systems installed on or after
Jan. 1, 2000. Resolution MSC.252(83) uses identical ``not inferior
to'' language in recommending measures applicable to INS systems
installed on or after Jan. 1, 2011.
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    Since late 2013, we have relieved the existing regulatory burden on
many tanker owners and operators by authorizing, on a case-by-case
basis and in specific Coast Guard Captain of the Port (COTP) zones,
deviations \11\ from the Sec.  164.13(d)(3) prohibition on a tanker's
use of an autopilot. To date, we have authorized 35 deviations allowing
tankers to operate specific IEC-compliant autopilots in fairway or TSS
waters within specific COTP zones. However, the authorization of
deviations does not relieve the regulatory burden for those who do not
apply for authorization, and what relief we do provide comes at the
expense of new burdens on industry and the Coast Guard. First, a tanker
owner or operator must apply for a deviation in each COTP zone in which
the tanker operates. Second, the cognizant COTP must ensure that the
tanker's autopilot is IEC-compliant, and then authorize the deviation.
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    \11\ Under 33 CFR 164.55. Deviations are authorized by letters
of deviation issued by the cognizant COTP.
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    We would like to eliminate all these burdens on industry and the
Coast Guard. Given that the apparent lack of standards in 1993 has now
been remedied, we propose amending 33 CFR 164.13 to allow tankers
equipped with specific IEC-compliant autopilots to use those systems in
fairway and TSS waters, without having to apply to individual COTPs for
deviations, and without the need for COTPs to ensure IEC compliance and
issue deviations. Not only will this eliminate the current burdens on
industry and the Coast Guard by giving force to IMO resolutions, it
will also promote both the United States' leading role in IMO affairs,
and the goals of Executive Order 13609, ``Promoting International
Regulatory Cooperation.'' \12\ Moreover, our proposal could enhance
maritime safety, because the autopilots in question offer far greater
precision and navigational safety than conventional autopilots, and
arguably, even human steering.
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    \12\ 77 FR 26413 (May 4, 2013).
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    For these reasons, we propose amending 33 CFR 164.13(d),
incorporating the existing substance of paragraph (d) and suspended
paragraph (e) with the substantive changes we will describe, and also
with nonsubstantive wording changes that are intended to improve Sec.
164.13's clarity. Except as noted, those nonsubstantive changes are
minor.
    In the introductory language in (d), we would make it clear that
the paragraph preempts (makes invalid) State or local laws intended to
regulate the same topic. Also, instead of the generic term
``autopilot,'' we would specify that (d) authorizes the use of only a
heading or track control system.
    In paragraph (d)(1), we would retain the existing Sec.
164.13(d)(3)(iii) and (iv) prohibitions against using a track or
heading control system within a half nautical mile of shore or within
any anchorage ground specified in 33 CFR part 110.
    In paragraph (d)(2), we would retain, but substantially revise for
clarity, the existing Sec.  164.13(d)(2) requirement for the full-time
presence of a qualified person to assume manual control of the tanker's
steerage.
    In paragraph (d)(3), we would replace the existing Sec.
164.13(d)(1) reference to an IMO autopilot compliance standard with a
reference to two editions of the IEC standard for heading and track
control systems.
    We would remove existing suspended paragraph (e). As revised,
paragraph (d) would replace the substance of that paragraph by setting
new requirements for the use of heading or track control systems in
fairway or TSS waters.

V. Incorporation by Reference

    Material proposed for incorporation by reference in 33 CFR 164.13
appears in the proposed amendment to 33 CFR 164.03. See ADDRESSES for
information on viewing this material. Copies of the material are
available from the sources listed in Sec.  164.03. Before publishing a
binding rule, we will submit this material to the Director of the
Federal Register for approval of the incorporation by reference. We
propose incorporating the International Electrotechnical Commission
standard IEC 62065, Edition 1.0 (2002-03) and Edition 2.0 (2014-02).
Both editions of this standard specify operational and performance
requirements and tests for heading and track control systems.

VI. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders (E.O.s) related to rulemaking. Below we summarize
our analyses based on these statutes or E.O.s.

A. Regulatory Planning and Review

    Executive Orders 12866, Regulatory Planning and Review, and 13563,
Improving Regulation and Regulatory Review, 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 (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563

emphasizes the importance of quantifying both costs and benefits, of
reducing costs, of harmonizing rules, and of promoting flexibility.
This proposed rule is not a ``significant regulatory action,'' under
section 3(f) of E.O. 12866. Accordingly, the rule has not been reviewed
by the Office of Management and Budget (OMB).
    A combined preliminary regulatory action (RA) and Threshold
Regulatory Flexibility Analysis follows and provides an evaluation of
the economic impacts associated with this proposed rule. The table
which follows provides a summary of the proposed rule's costs and
benefits.

               Table 1--Summary of the Proposal's Impacts
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                Category                             Summary
------------------------------------------------------------------------
Potentially Affected Population........  An estimated 9,458 foreign-
                                          flagged vessels that are owned
                                          by 2,285 companies and 95 U.S.-
                                          flagged vessels that are owned
                                          by 40 businesses.
Costs (7% discount rate) (costs only     $12,403.
 accrue in the first year).
10-Year Total Quantified Cost Savings    $85,220.
 (7% discount rate).
10-Year Net Cost Savings (7% discount    $72,816.
 rate).
Annualized Net Savings (7% discount      $10,367.
 rate).
Unquantified Benefits..................  * Improve effectiveness without
                                          compromising safety.
                                         * Prevent misuse and
                                          misunderstandings.
                                         * Improved goodwill between
                                          regulated public and Coast
                                          Guard.
------------------------------------------------------------------------

    The proposed rule would revise the existing regulations regarding
navigation on tankers. It would update the regulations to lift the
suspension on tanker use of autopilot systems that has been in place
since 1993 and which is no longer needed and update the performance
standard for traditional autopilot systems referenced in 33 CFR
164.13(d). The proposed rule, if finalized, would remove an unnecessary
regulatory restriction and result in an overall cost savings for the
regulated public and the Coast Guard.
Affected Population
    Based on the Coast Guard's MISLE database, we estimate that this
proposed rule would affect approximately 9,458 foreign-flagged vessels
and approximately 95 U.S.-flagged vessels. No governmental
jurisdictions would be impacted.
Costs
    The Coast Guard expects that this rule, if promulgated, would
result in one-time costs of approximately $12,403 (7% discount) or an
undiscounted cost of $13,272.\13\ These costs would be derived by
regulated entities needing to communicate to their vessel staff
information about the proposed change (a regulatory familiarization
cost). The Coast Guard estimates that approximately 4 minutes (0.067
hour) would be expended per company to do so; these communications are
anticipated to be via electronic bulletin boards or mass distribution
email. Labor costs are estimated at $85.20 per hour (fully loaded to
account for the cost of employee benefits) for an operations manager
based on a mean wage rate of $55.81; this estimate is based on Bureau
of Labor Statistics (BLS) Occupational Employment Statistics,
Occupational Employment and Wages data, for General and Operations
Managers for Industrial Production (11-1021, May 2013).\14\ From there,
we applied a load factor of 1.53, to determine the actual cost of
employment to employers and industry.\15\ The following table presents
the estimated cost of compliance with the rulemaking.
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    \13\ As derived by the summation of the equations: [0.067 hour *
$85.20 marine operations manager wage rate * (2,285 foreign-flagged
vessel owner/operators + 40 U.S.-flagged vessel owner/operators)] *
7% discount rate.
    \14\ The reader may review the source data at http://www.bls.gov/oes/2013/may/oes111021.htm. Also please see http://www.bls.gov/oes/2013/may/oes436014.htm for the wage rate for an
administrative assistant. After adding the load factor the wage rate
for an administrative assistant is estimated to be $24.96. The wage
rate for a lead engineer is estimated to be $100.22, which is
derived from the product of the unloaded wage rate as found on the
BLS Web site (http://www.bls.gov/oes/2013/may/oes119041.htm) and the
load factor (1.53 rounded).
    \15\ This load factor is calculated specifically for production,
transportation and material moving occupations, Full-time, Private
Industry (Series ID: CMU2010000520000D,CMU2010000520000P and
CMU2020000520000D,CMU2020000520000P), 2014, 4th Quarter. Total cost
of compensation per hour worked: $27.31, of which $17.89 is wages,
resulting in a load factor of 1.526551 ($27.31/$17.89). USCG rounded
this factor to 1.53 (rounded to the nearest hundredth). (Source:
http://www.bls.gov/ncs/ect/data.htm as accessed on March 18, 2015.
Using similar applicable industry groups and time periods results in
the same estimate of load factor.

                           Table 2--Total Estimated Cost of Regulatory Familiarization
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                                                                   Discounted 7%   Discounted 3%   Undiscounted
----------------------------------------------------------------------------------------------------------------
Year 1..........................................................         $12,403         $12,885         $13,272
Year 2..........................................................               0               0               0
Year 3..........................................................               0               0               0
Year 4..........................................................               0               0               0
Year 5..........................................................               0               0               0
Year 6..........................................................               0               0               0
Year 7..........................................................               0               0               0
Year 8..........................................................               0               0               0
Year 9..........................................................               0               0               0
Year 10.........................................................               0               0               0
                                                                 -----------------------------------------------
    Total.......................................................          12,403          12,885          13,272
Annualized......................................................           1,766           1,511           1,327
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    The Coast Guard has not estimated a cost to comply with the
documents proposed to be incorporated by reference (International
Electrotechnical Commission's standards IEC 62065, 2014-02; IMO
Resolution MSC.74(69), Annex 2.) The Coast Guard has not estimated a
cost for these provisions because manufacturers participate in the
development of the standards at IEC and are aware of the changes to
standards. As a result they already have been producing equipment to
meet the standard; manufacturers typically will begin to make
manufacturing modifications even before such changes are formally
adopted. The proposal would not require owners and operators to acquire
the standards; they would not need the standard in hand to be in
compliance. They simply would look for evidence from manufacturers that
products meet or exceed the standard before purchase. For these
reasons, the Coast Guard has not included a cost for these provisions.
    No equipment would be required by the rule. As well, some parts of
the affected population would experience no cost increase due to the
rulemaking, since some vessels do not use autopilot under the
conditions noted in the proposal; therefore they would have no costs.
No further action would be required by these parties. Only 40 U.S.
vessel owners and operators and approximately 2,285 foreign vessel
owners and operators are potentially impacted; for these, they would
incur a cost only if they need to communicate to staff the proposed
rules changes on the use of autopilot.
Cost Savings
    The proposal would result in cost savings for the regulated public
and the Coast Guard. The proposed rule would prevent unnecessary
inquiries to the Coast Guard regarding regulations and the filing of
(and Coast Guard processing of) letters of deviation (LODs). With
regard to the first cost savings, the Coast Guard estimates that it
spends a collective 20 hours annually (one hour per call on average)
fielding calls from the regulated public seeking clarification of the
intent of the existing regulations. This labor cost for the regulated
public and the Coast Guard would be eliminated by the proposed
rule.\16\ To estimate these costs, the Coast Guard used publicly
available data as found in the Memorandum of the Commandant entitled
``Coast Guard Reimbursable Standard Rates.'' \17\ Labor costs are
estimated for the Coast Guard at $88 \18\ for a Lieutenant Commander.
This figure represents a wage rate with a fully loaded labor factor of
1.85 for uniformed Coast Guard positions. For the regulated public, the
wage rate for a lead engineer is estimated to be $100.22 per hour,
based upon a load factor applied to the BLS wage data; the unloaded
wage rate for an engineering manager is $65.65 and the load factor is
1.53 (rounded).\19\ The total cost savings from the elimination of
inquiries to Coast Guard is estimated at $3,764 per year.\20\
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    \16\ 20 hours annually * wage rate for lead engineer. The
Government's cost is estimated by the equation 20 hours annually *
wage rate for Coast Guard Lieutenant Commander (O-4).
    \17\ The memorandum is dated February 11, 2015 and is numbered
COMDTINST 7310.1P. Enclosure 2 lists the relevant data. The
memorandum may be found on www.uscg.mil/directives/ci/7000-7999/CI_7310_1p.PDF. This document is known as Commandant Instruction P.
    \18\ See http://www.uscg.mil/directives/ci/7000-7999/CI_7310_1p.PDF, See Enclosure 2 for in-government rate of an O-4
officer and a GS-11 employee.
    \19\ This is the wage rate for 11-9041 Architectural and
Engineering Managers as found at http://www.bls.gov/oes/2013/may/oes119041.htm and as accessed on February 12, 2015. As noted
earlier, a load factor of 1.53 was applied.
    \20\ Coast Guard Cost Savings: ($88 Lt Commander * 1 hour * 20
calls per year = $1760) Regulated Public Cost Savings: ($100.22 lead
engineer * 1 hour * 20 calls per year = $2004).
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    In addition, the proposal would save the regulated public and the
Coast Guard labor costs associated with the filing and processing of
annual LODs. The proposal would preclude the need for the regulated
public to file an LOD. In doing so, it would preclude the need for the
Coast Guard to process the LOD and respond to it. The Coast Guard
estimates that each LOD requires a given marine business to expend 1.7
hours of an operations manager's time and 0.5 hour of an administrative
assistant's time to prepare and submit the LOD. These precluded costs
would be incurred annually and would be calculated by the sum of the
products of the loaded wage rates and labor duration estimates times
the number of requests per year.\21\ In turn, we estimate that the
Coast Guard would spend 0.6 hour of a Lieutenant Commander's time; and
0.5 of an administrative assistant's time to process, review and
respond to each LOD request. The loaded wage rates for these positions
are: $88 for a Lieutenant Commander (O-4); $58 for an administrative
assistant (GS-11). These wage rates may be found in Commandant
Instruction P (Enclosure 2's in-government rates).
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    \21\ ($85.20/hour operations manager's wage rate * 1.7 hours) +
($24.96/hour admin assistant's wage rate * 0.5 hour) * (35
submissions) Wage data may be found from the US Bureau of Labor
Statistics (http://www.bls.gov/oes/2013/may/oes111021.htm and http://www.bls.gov/oes/2013/may/oes436014.htm).
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    To estimate these cost savings, we requested data from Coast Guard
sectors on their experience with processing LODs. Based on that review,
we estimated the number of LOD requests to be approximately 35
annually, which would be precluded by the proposed rule. We also
reviewed previous Coast Guard regulatory analyses for the labor costs
of the regulated public for filing waiver requests. Our estimated
durations for labor for the regulated public and for the Coast Guard
are based on Coast Guard experience with LOD requests as well as an
existing information collection, which is entitled Ports and Waterways
Safety--Title 33 CFR Subchapter P (RIN 1625-0043; the Coast Guard's
proposed rule for cranes (RIN 1625-AB78, USCG-2011-0992); and the
proposed and final rules for Vapor Control Systems (RIN 1625-AB37,
USCG-1999-5150). We used the existing information collection 1625-0043
to obtain the estimates of existing tasks; we used the information
collections for cranes and vapor control systems to estimate tasks that
were not in 1625-0043, but were similar to the tasks of these
information collections. We estimate that the regulated public would
spend approximately 2.2 hours to prepare the paperwork and to file an
LOD.\22\ In addition, we estimate that the Coast Guard spends 1.1 hours
in total for each LOD.\23\
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    \22\ 35 waivers annually * [1.7 hours * wage rate for operations
manager + 0.5 hour * wage rate for an admin assistant].
    \23\ 35 waivers annually * [0.6 hour * wage rate for Lt.
Commander + 0.5 hour * wage rate for Coast Guard admin assistant].
---------------------------------------------------------------------------

    Total cost savings per year would be $12,133.\24\ The following
table presents the estimated cost savings.
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    \24\ $4,623 in Government cost savings plus $7,510 in regulated
public cost savings.

                                                                               Table 3--Total Cost Savings by Year
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Cost savings to the regulated public         Cost savings to the government             Total estimated cost savings
                                                                   -----------------------------------------------------------------------------------------------------------------------------
                               Year                                  Annualized   Annualized                   Annualized   Annualized                   Annualized   Annualized
                                                                         7%           3%       Undiscounted        7%           3%       Undiscounted        7%           3%       Undiscounted
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................................................      -$7,019      -$7,292         -$7,510      -$4,321      -$4,488         -$4,623     -$11,340     -$11,780        -$12,133
2.................................................................       -6,560       -7,079          -7,510       -4,038       -4,358          -4,623      -10,598      -11,437         -12,133
3.................................................................       -6,131       -6,873          -7,510       -3,774       -4,231          -4,623       -9,904      -11,104         -12,133
4.................................................................       -5,730       -6,673          -7,510       -3,527       -4,107          -4,623       -9,256      -10,780         -12,133
5.................................................................       -5,355       -6,478          -7,510       -3,296       -3,988          -4,623       -8,651      -10,466         -12,133
6.................................................................       -5,004       -6,290          -7,510       -3,081       -3,872          -4,623       -8,085      -10,161         -12,133
7.................................................................       -4,677       -6,107          -7,510       -2,879       -3,759          -4,623       -7,556       -9,866         -12,133
8.................................................................       -4,371       -5,929          -7,510       -2,691       -3,649          -4,623       -7,062       -9,578         -12,133
9.................................................................       -4,085       -5,756          -7,510       -2,515       -3,543          -4,623       -6,600       -9,299         -12,133
10................................................................       -3,818       -5,588          -7,510       -2,350       -3,440          -4,623       -6,168       -9,028         -12,133
10-Year...........................................................      -52,750      -64,065         -75,104      -32,470      -39,435         -46,230      -85,220     -103,500        -121,334
Annualized........................................................       -7,510       -7,510  ..............       -4,623       -4,623  ..............      -12,133      -12,133  ..............
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    The proposed rule would result in a net cost savings of $72,816 (7%
discount rate for a 10 year period) since the estimated cost savings
exceed the costs of the proposed rule. Costs are incurred only in year
1. The net cost savings of the proposal are calculated by subtracting
the total cost of the rule ($12,403) from the total cost savings
($85,220). These cost savings result from precluded labor costs to the
regulated public and to the Coast Guard as noted earlier. Table 4
presents the cost savings of the proposal.

                                       Table 4--Estimated Net Cost Savings
----------------------------------------------------------------------------------------------------------------
                                                                   Discounted 7%   Discounted 3%   Undiscounted
----------------------------------------------------------------------------------------------------------------
Year 1..........................................................          $1,064          $1,105          $1,138
Year 2..........................................................         -10,598         -11,437         -12,133
Year 3..........................................................          -9,904         -11,104         -12,133
Year 4..........................................................          -9,256         -10,780         -12,133
Year 5..........................................................          -8,651         -10,466         -12,133
Year 6..........................................................          -8,085         -10,161         -12,133
Year 7..........................................................          -7,556          -9,866         -12,133
Year 8..........................................................          -7,062          -9,578         -12,133
Year 9..........................................................          -6,600          -9,299         -12,133
Year 10.........................................................          -6,168          -9,028         -12,133
                                                                 -----------------------------------------------
    Total.......................................................         -72,816         -90,615        -108,062
                                                                 -----------------------------------------------
Annualized......................................................         -10,367         -10,623         -10,806
----------------------------------------------------------------------------------------------------------------

Benefits
    The proposed rule would amend existing regulations to remove the
requirements that prohibit tanker use of autopilot systems. The
proposal also would update the performance standard for traditional
autopilot systems. The Coast Guard is pursuing this amendment to
existing standards in order to prevent inefficient use of labor and to
add clarity to the current system; the proposal would prevent
inefficient use of labor (as noted in the cost savings discussion
earlier) and would add clarity to the regulated public as to the need
for safety precautions. The proposed changes would improve regulatory
intent and keep regulations in step with existing technology without
compromising the existing level of safety. Instead, the proposed rule
would promote maritime safety by eliminating confusion associated with
outdated regulations that have not kept pace with technology.
Regulatory Alternatives Considered
    In developing the proposal, the Coast Guard considered the
following alternatives when developing the proposed rule:
    1. Take no action.
    2. Develop a different time table for small entities.
    3. Provide an exemption for small entities (from the proposed rule
or any part thereof).
    The first alternative is not preferred because it does not offer
solutions to issues identified earlier in the preamble. It would
perpetuate an inefficient use of labor on the part of the regulated
public and the Coast Guard. The second alternative prevents small
entities from benefiting from the efficiencies made possible by this
regulation as soon as the larger companies, while the third alternative
would prevent small entities from enjoying the benefits of these
efficiencies at all. As this regulation reduces an unnecessary
regulatory restriction, the Coast Guard does not want to restrict its
applicability to small entities in any way.
    Most entities are expected to experience no additional cost; for
those who would incur a cost, the Coast Guard estimates costs to be
less than $6 per entity.\25\ Cost savings would accrue only to those
covered by the rulemaking and who have not already applied for a waiver
or who are not in compliance with the existing regulations. An
exemption would preclude cost savings to those under the exemption; the
Coast Guard estimates that cost savings would be less than $200 per
affected entity annually.\26\
---------------------------------------------------------------------------

    \25\ As noted earlier, the cost to communicate information is
calculated by the equation $85.20 wage rate * 0.067 hour.
    \26\ Labor to make an inquiry is estimated by the equation: 1.7
hours * wage rate for operations manager + 0.5 hour * wage rate for
an admin assistant.
---------------------------------------------------------------------------

    For the reasons discussed earlier, we rejected these alternatives
in favor of the

preferred alternative. The preferred alternative (the proposed rule)
would amend existing regulations to remove the requirements that
prohibit tanker use of autopilot systems. The preferred alternative
also would update the performance standard for traditional autopilot
systems.

B. Small Entities

    Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of fewer than
50,000 people.
    The Coast Guard expects that this proposed rule would not have a
significant economic impact on small entities. As described in the
``Regulatory Planning and Review'' section, the Coast Guard expects
this proposed rule to result in net cost savings to regulated entities.
An estimated 67 percent of the regulated companies (a total of 27
businesses) are considered small by the Small Business Administration
(SBA) industry size standards; for any company for which we were not
able to find SBA size data, we assumed it was a small entity. The
compliance costs for this proposed rule (which are only regulatory
familiarization costs) would amount to less than 1 percent of revenue
for all small entities ($5.71 per entity) and, therefore, do not
represent a significant economic impact on a substantial number of
small entities. Costs would be incurred only in the first year of the
final rule's enactment. No additional costs for labor or equipment
would be incurred in future years. In fact, as this rule is removing an
unnecessary regulatory restriction, this rule is expected to reduce
labor costs. No small governmental jurisdictions are impacted by the
proposed rule.
    Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that
this proposed rule, if promulgated, would not have a significant
economic impact on a substantial number of small entities. If you think
that your business, organization, or governmental jurisdiction
qualifies as a small entity and that this proposed rule would have a
significant economic impact on it, please submit a comment to the
Docket Management Facility at the address under ADDRESSES. In your
comment, explain why you think it qualifies and how and to what degree
this proposed rule would affect it economically.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996, Public Law 104-121, we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
proposed rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact the Coast Guard
(see ADDRESSES). The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.
    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 businesses. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).

D. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520; the
proposed rule would not add requirements for recording and
recordkeeping to the existing collection which is entitled Ports and
Waterways Safety--Title 33 CFR Subchapter P and which is numbered 1625-
0043. However, the proposed rule would adjust this collection. As
defined in 5 CFR 1320.3(c), ``collection of information'' comprises
reporting, recordkeeping, monitoring, posting, labeling, and other
similar actions. The proposed rule would not require additional tasks
by the regulated public but would eliminate the need for the regulated
public to file LODs under conditions as specified by the proposed rule.
The Coast Guard estimates that there would be 35 fewer LODs filed
annually because of the proposed rule's changes.
    The existing collection of information requires LODs to be
submitted to the Coast Guard for various reasons; one of which is for
tankers to use autopilot under conditions noted in the proposal. Under
the proposed rule, Coast Guard would no longer require an LOD for
tankers as specified in the proposal. The proposal would preclude the
need for 35 or fewer LODs annually to be submitted to the Coast Guard
for approval. It also would preclude the need for the Coast Guard to
process and approve those LODs. The collection of information aids the
regulated public in assuring safe practices; however, the Coast Guard
has concluded that this particular use of LODs is no longer warranted.
    This proposed rule would amend an existing collection of
information as defined by the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520); the rule removes regulatory requirements which
necessitate the filing of LODs under conditions as specified in the
proposed rule. As defined in 5 CFR 1320.3(c), ``collection of
information'' comprises reporting, recordkeeping, monitoring, posting,
labeling, and other similar actions. The title and description of the
information collections, a description of those who must collect the
information, and an estimate of the total annual burden follow. The
estimate covers the time for gathering and maintaining the data needed,
and completing and reviewing the collection.
    Title: Ports and Waterways Safety--Title 33 CFR Subchapter P.
    OMB Control Number: 1625-0043.
    Summary of the Collection of Information: The existing collection
of information requires written responses such as LODs. Under the
proposed rule, the Coast Guard would no longer require an LOD to be
submitted under specific conditions as noted in the proposal; LODs
would continue to be required for other existing reasons. The
collection of information aids the regulated public in assuring safe
practices.
    Need for Information: The Coast Guard needs this information to
determine whether an entity meets the regulatory requirements.
    Proposed Use of Information: The Coast Guard uses this information
to determine whether an entity request for deviation is justified.
    Description of the Respondents: The respondents are owners and
operators of vessels which travel in the regulated waterways as noted
in the regulatory text.
    Number of Respondents: The burden of this proposed rule for this
collection of information includes submittal of LODs. This collection
of information applies to owners/operators of vessels which travel in
the regulated waterways. We estimate the maximum number of respondents
is 35 per year.
    Frequency of Responses: Letters of Deviation under the conditions
noted in

the proposal are filed once per year. The proposal would eliminate the
need for this particular use of the LOD. The Coast Guard estimates that
35 fewer LODs would be filed annually because of the proposal.
    Burden of Response: The burden of response for each LOD is an
estimated 2.2 hours.
    Estimate of Total Annual Burden: This proposed rule would decrease
burden hours by 77 hours from the previously approved burden estimate
of 2,110.
    As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we will submit a copy of this proposed rule to OMB for its
review of the collection of information.
    We invite public comment on the proposed collection of information.
Advise us on how useful the information is; whether it can help us
perform our functions better; whether it is readily available
elsewhere; how accurate our estimate of the burden of collection is;
how valid our methods for determining burden are; how we can improve
the quality, usefulness, and clarity of the information; and how we can
minimize the burden of collection.
    You need not respond to a collection of information unless it
displays a currently valid control number from OMB. Before the Coast
Guard could enforce the collection of information requirements in this
rule, OMB would need to approve the Coast Guard's request to collect
this information.

E. Federalism

    A rule has implications for federalism under E.O. 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 E.O. 13132. Our
analysis is explained below.
    It is well settled that States may not regulate in categories
reserved for regulation by the Coast Guard. It is also well settled,
now, that all of the categories covered in 46 U.S.C. 3306, 3703, 7101,
and 8101 (design, construction, alteration, repair, maintenance,
operation, equipping, personnel qualification, and manning of vessels),
as well as the reporting of casualties and any other category in which
Congress intended the Coast Guard to be the sole source of a vessel's
obligations, are within the field foreclosed from regulation by the
States. (See the decision of the Supreme Court in the consolidated
cases of United States v. Locke and Intertanko v. Locke, 529 U.S. 89,
120 S.Ct. 1135 (March 6, 2000)). This rule is promulgated under Title
II of the Ports and Waterways Safety Act \27\ (46 U.S.C. 3703) and
amends existing regulations for tank vessels regarding certain vessel
equipment technical standards and operation. Under the principles
discussed in Locke, States are foreclosed from regulating within this
field. Thus, the rule is consistent with the principles of federalism
and preemption requirements in E.O. 13132.
---------------------------------------------------------------------------

    \27\ Public Law 92-340, 86 Stat. 424, as amended; codified at 33
U.S.C. 1221 et seq- 1232.
---------------------------------------------------------------------------

    While it is well settled that States may not regulate in categories
in which Congress intended the Coast Guard to be the sole source of a
vessel's obligations, the Coast Guard recognizes the key role that
State and local governments may have in making regulatory
determinations. Additionally, for rules with federalism implications
and preemptive effect, E.O. 13132 specifically directs agencies to
consult with State and local governments during the rulemaking process.
If you believe this rule has implications for federalism under E.O.
13132, please contact the person listed in the FOR FURTHER INFORMATION
CONTACT section of this preamble.

F. Unfunded Mandates Reform Act

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

 G. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under E.O. 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

H. Civil Justice Reform

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

I. Protection of Children

    We have analyzed this proposed rule under E.O. 13045, Protection of
Children from Environmental Health Risks and Safety Risks. This
proposed rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

 J. Tribal Governments

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

K. Energy Effects

    We have analyzed this proposed rule under E.O. 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under E.O. 13211 because it is not a ``significant
regulatory action'' under E.O. 12866 and is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.

L. Technical Standards

    The National Technology Transfer and Advancement Act, codified as a
note to 15 U.S.C. 272, directs agencies to use voluntary consensus
standards in their regulatory activities unless the agency provides
Congress, through OMB, with an explanation of why using these standards
would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g.,
specifications of materials, performance, design, or operation; test
methods; sampling procedures; and related management systems practices)
that are developed or adopted by voluntary consensus standards bodies.
This proposed rule uses voluntary consensus standards to track control
and integrated navigation systems used in vessel automatic pilot
systems. These standards provide parameters within which these systems
must operate to ensure proper navigational control given the vessel's
position, heading, speed, and other factors. The standards were
developed by the International Electrotechnical Commission, an
international voluntary consensus

standards-setting organization, and the IMO.

M. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.1D, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969, 42 U.S.C. 4321-4370f, and we have
made a preliminary determination that this action is one of a category
of actions that do not individually or cumulatively have a significant
effect on the human environment. A preliminary environmental analysis
checklist supporting this categorical exclusion determination is
available in the docket where indicated under the ``Public
Participation and Request for Comments'' section of this preamble.
    This proposed rule involves regulations concerning tank vessel
equipment approval and operation. Thus, this proposed rule will likely
be categorically excluded under Section 2.b.2, figure 2-1, paragraph
34(d), (e), and (i) of the Instruction and Section 6(a) of the
``Appendix to National Environmental Policy Act: Coast Guard Procedures
for Categorical Exclusions, Notice of Final Agency Policy'' (67 FR
48243, July 23, 2002). We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

List of Subjects in 33 CFR Part 164

    Marine, Navigation (water), Incorporation by reference, Reporting
and recordkeeping requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 164 as follows:

Title 33--Navigation and Navigable Waters

PART 164--NAVIGATION SAFETY REGULATIONS

0
1. The authority citation for part 164 is revised to read as follows:

    Authority:  33 U.S.C. 1223, 1231; 46 U.S.C. 2103, 3703; and E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277. Sec. 164.13 also
issued under 46 U.S.C. 8502. Sec. 164.46 also issued under 46 U.S.C.
70114 and Sec. 102 of Pub. L. 107-295. Sec. 164.61 also issued under
46 U.S.C. 6101. The Secretary's authority under these sections is
delegated to the Coast Guard by Department of Homeland Security
Delegation No. 0170.1, para. II (70), (92.a), (92.b), (92.d),
(92.f), and (97.j).

0
2. Amend Sec.  164.03 by adding paragraph (h) to read as follows:

Sec.  164.03  Incorporation by reference.

* * * * *
    (h) International Electrotechnical Commission (IEC), 3, rue de
Varembe, Geneva, Switzerland, +41 22 919 02 11, http://www.iec.ch/.
    (1) IEC 62065 Edition 1.0 (2002-03), Maritime navigation and
radiocommunications equipment and systems--Track control systems--
Operational and performance requirements, methods of testing and
required test results--incorporation by reference approved for Sec.
164.13(d).
    (2) IEC 62065 Edition 2.0 (2014-02), Maritime navigation and
radiocommunications equipment and systems--Track control systems--
Operational and performance requirements, methods of testing and
required test results--incorporation by reference approved for Sec.
164.13(d).
0
3. Amend Sec.  164.13 by removing paragraph (e) and revising paragraph
(d) to read as follows:

Sec.  164.13  Navigation underway: Tankers.

* * * * *
    (d) This paragraph (d) has preemptive effect over State or local
regulation within the same field. A tanker may navigate using a heading
or track control system only if--
    (1) The tanker is beyond one-half nautical mile off shore or not
within waters specified in 33 CFR part 110 (anchorages);
    (2) There is a person, competent to steer the vessel, present to
assume manual control of the steering station; and
    (3) The system meets the heading or track control specifications of
either IEC 62065 (2002:03) or IEC 62065 (2014:02) (incorporated by
reference, see Sec.  164.03).

    Dated: June 28, 2016.
David C. Barata,
Acting Director of Marine Transportation Systems Management, U.S. Coast
Guard.
[FR Doc. 2016-15791 Filed 7-8-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Rules and Regulations]
[Pages 27923-27925]
[FR Doc No: 2022-09815]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0084; Project Identifier MCAI-2020-01312-A;
Amendment 39-22012; AD 2022-08-09]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Pilatus Aircraft Ltd. (Pilatus) Model PC-24 airplanes. This AD was
prompted by a failure of the dual ethernet communication channel on a
dual-channel data concentration and processing unit, which triggered
the opening of electronic circuit breakers that caused several
unintended system activations. This AD requires installing a software
(SW) upgrade to the utility management system (UMS), as specified in a
European Union Aviation Safety Agency (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective June 14, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 14,
2022.

ADDRESSES: For EASA material incorporated by reference in this final
rule, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
phone: +49 221 8999 000; email: [email protected]; website:
www.easa.europa.eu. You may find the EASA material on the EASA website
at https://ad.easa.europa.eu. For service information identified in
this final rule, contact Pilatus Aircraft Ltd., CH-6371, Stans,
Switzerland; phone: +41848247365; email: aircraft.com">[email protected]aircraft.com; website: http://www.pilatus-aircraft.com/. You may view
this material at the FAA, Airworthiness Products Section, Operational
Safety Branch, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.
Service information that is approved for IBR is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2022-0084.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0084; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
EASA AD, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0200, dated September 21, 2020
(EASA AD 2020-0200), to correct an unsafe condition on Pilatus Model
PC-24 airplanes, all serial numbers. EASA AD 2020-0200 was prompted by
a report that, during climb, a Model PC-24 airplane experienced a dual
ethernet communication channel failure on a dual-channel data
concentration and processing unit. The failure triggered the opening of
electronic circuit breakers, which led to degradation of environmental
control system functionalities, the deployment of all passenger oxygen
masks, and the autopilot entering into emergency descent mode.
According to EASA, various crew alerting system messages were displayed
and the functionality of other systems (such as flaps, fuel indication,
and the ice protection system) was significantly degraded.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Pilatus Model PC-24
airplanes. The NPRM published in the Federal Register on February 3,
2022 (87 FR 6087). The NPRM was prompted by the failure of the dual
ethernet communication channel on a dual-channel data concentration and
processing unit identified in EASA AD 2020-0200. The NPRM proposed to
require installing a SW upgrade to the UMS, as specified in EASA AD
2020-0200.
    The FAA is issuing this AD to prevent failure of the dual ethernet
communication channel on a dual-channel data concentration and
processing unit. The unsafe condition, if not addressed, could result
in increased pilot workload and reduced control of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These airplanes have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA notified the FAA about the
unsafe condition described in the EASA AD. The FAA reviewed the
relevant data and determined that air safety requires adopting this AD
as proposed. Accordingly, the FAA is issuing this AD to address the
unsafe condition on these products. This AD is adopted as proposed in
the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2020-0200, which specifies upgrading the
UMS SW and prohibits installing an earlier version of the SW. This
material is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Pilatus PC-24 Service Bulletin No. 42-010, dated
January 21, 2020. This service information contains procedures for
upgrading the UMS SW to Build 7.3.

Differences Between This AD and the EASA AD

    Where EASA AD 2020-0200 requires compliance after its effective
date, this AD requires using the effective date of this AD. Where EASA
AD 2020-0200 prohibits the installation of an affected part ``from the
effective date'' of EASA AD 2020-0200, this AD requires using ``as of
the effective date of this AD.'' Although the service information
referenced in EASA AD 2020-0200 specifies reporting information to the
manufacturer, this AD does not include that requirement.

Costs of Compliance

    The FAA estimates that this AD affects 42 airplanes of U.S.
registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor Cost           Parts cost       airplane        operators
----------------------------------------------------------------------------------------------------------------
Install SW upgrade to UMS.............  8 work-hours x $85 per            $5,000          $5,680        $238,560
                                         hour = $680.
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-08-09 Pilatus Aircraft Ltd.: Amendment 39-22012; Docket No.
FAA-2022-0084; Project Identifier MCAI-2020-01312-A.

(a) Effective Date

    This airworthiness directive (AD) is effective June 14, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pilatus Aircraft Ltd. Model PC-24 airplanes,
all serial numbers, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 2200, Auto Flight
System; 2400, Electrical Power System; 3140, Central Computers
(EICAS); 3500, Oxygen System; and 4500, Central Maint, Computer.

(e) Unsafe Condition

    This AD was prompted by a failure of the dual ethernet
communication channel on a dual-channel data concentration and
processing unit, which triggered the opening of electronic circuit
breakers that caused several unintended system activations. The FAA
is issuing this AD to prevent failure of the dual ethernet
communication channel on a dual-channel data concentration and
processing unit. The unsafe condition, if not addressed, could
result in increased pilot workload and reduced control of the
airplane.

(f) Compliance

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

(g) Required Actions

    (1) For Group 1 airplanes as defined under the ``Definitions''
section in European Union Aviation Safety Agency AD 2020-0200, dated
September 21, 2020 (EASA AD 2020-0200): Install the build 7.3
standard software upgrade to the utility management system software
in accordance with paragraph 1 and the ``Ref. Publications'' section
of EASA AD 2020-0200, except you are required to comply within 30
days after the effective date of this AD. After updating the
software, do not install on that airplane utility management system
software that is earlier than version 7.3.
    (2) For Group 2 airplanes as defined under the ``Definitions''
section in EASA AD 2020-0200: As of the effective date of this AD,
do not install utility management system software that is earlier
than version 7.3 on any airplane.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (i) of
this AD and email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    For more information about this AD, contact Doug Rudolph,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 901 Locust, Room 301, Kansas
City, MO 64106; phone:<PHONE_NUMBER>; email: [email protected].

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0200,
dated September 21, 2020.
    (ii) [Reserved]
    (3) For EASA material identified in this AD, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999
000; email: [email protected]; website: www.easa.europa.eu. You may
find the EASA material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may
be found in the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0084.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 3, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-09815 Filed 5-9-22; 8:45 am]
BILLING CODE 4910-13-P


J-22-0019-0020 Sanitized Support Documents Index:
 J-22-0019 Sanitized Biotech Form (linked)
 J-22-0020 Sanitized Biotech Form (linked)
 J-22-0019-0020 Sanitized Determination Document (linked)
 J-22-0019-0020 Sanitized Risk Assessment (attached)


Diflubenzuron Focus Meeting Summary

 August 22, 2012

1:00 – 2:00 pm

Objective

The purpose of the meeting was for members of the Environmental
Protection Agency Office of Pesticide Programs’ Pesticide
Re-evaluation Division (PRD), Environmental Fate and Effects Division
(EFED), Health Effects Division (HED), Biological and Economic Analysis
Division (BEAD), and Registration Division (RD) to meet with Chemtura
Corporation (Chemtura), a technical registrant for diflubenzuron, to get
a better understanding of the need for and scope of a residential
exposure assessment during registration review.

Attendees

Chemtura (via conference call): Kevin Donovan, Judy Ball

EPA: Steven Snyderman (PRD), Avivah Jakob (PRD), Tracy Perry (PRD), John
Hebert (RD), Autumn Metzger (RD), Sue Hummel (HED), James Miller (HED),
Don Atwood (BEAD), John Faulkner (BEAD), Faruque Khan (EFED)

Discussion

In response to Agency questions regarding its diflubenzuron products,
Chemtura detailed specific use information and gave a broader
understanding of total U.S. usage of these non-agricultural products.
The discussion covered: 1) non-agricultural uses, including better
characterization of outdoor forest lands, standing water, tree shrub,
recreational area, and ornamental plant uses (i.e., application rates,
number of applications, acres treated, and timing of applications); and
2) the general usage of residential products registered for use on bird
ponds, pool tarps, and as an impregnated wood termiticide.  Of
particular value was the applicator information on the residential uses
for the EPA Reg. No. 400-543 label (i.e., bird ponds, fountains, small
water gardens, pool tarps, and impregnated wood termite use).  In
addition, Chemtura explained its minor use products, including
registered feed-through cattle labels.

Follow-up

Based on the discussion, the Agency concluded that a residential handler
and post-application exposure assessment is needed in registration
review.  EPA will continue to work with Chemtura and other diflubenzuron
registrants to clarify labels.


[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70837-70838]
[FR Doc No: 2021-26670]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R09-OAR-2021-0629; FRL 9252-01-R9]

Final Agency Action To Issue a Prevention of Significant
Deterioration Non-Applicability Determination for the AltAir Renewable
Fuels Project

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final agency action.

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

SUMMARY: This notice announces that the Environmental Protection Agency
(EPA) issued a final agency action for a Clean Air Act Prevention of
Significant Deterioration (PSD) Non-Applicability Determination to
AltAir Paramount, LLC (``AltAir''), for its Renewable Fuels Project in
California's South Coast Air Basin. AltAir plans to convert the
remainder of the existing Paramount Crude Oil Refinery into a renewable

fuels facility. As part of this Renewable Fuels Project, existing
equipment will be re-used and re-purposed, new equipment will be
installed, unneeded equipment will be eliminated or permanently idled,
and project upgrades to existing equipment will be made to improve
efficiencies and reduce operational emissions. In its Non-Applicability
Determination, the EPA determined that the Renewable Fuels Project will
not result in a major PSD modification.

DATES: The PSD Non-Applicability Determination issued on November 3,
2021, was a final agency action. Pursuant to section 307(b)(1) of the
Clean Air Act, 42 U.S.C. 7607(b)(1), judicial review of this final
agency action may be sought by filing a petition for review in the
United States Court of Appeals for the Ninth Circuit within 60 days of
December 13, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2021-0629. Publicly available docket
materials, including the determination letter and supporting
documentation, are available through https://www.regulations.gov, or by
contacting the person identified in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: La Weeda Ward, Permits Office (Air-3-
1), U.S. Environmental Protection Agency, Region 9,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Notice of Final Action

    On November 3, 2021, EPA notified AltAir that based on EPA's review
of AltAir's PSD Applicability Evaluation, the Renewable Fuels Project
is not a major modification that requires a PSD permit under 40 CFR
52.21.

    Dated: November 10, 2021.
Elizabeth Adams,
Acting Regional Administrator Region IX.
[FR Doc. 2021-26670 Filed 12-10-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6750-6751]
[FR Doc No: 2023-02106]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0093]

M13A Bioequivalence for Immediate-Release Solid Oral Dosage
Forms; International Council for Harmonisation; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``M13A
Bioequivalence for Immediate-Release Solid Oral Dosage Forms.'' The
draft guidance was prepared under the auspices of the International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH). The draft guidance describes the scientific and
technical aspects of study design and data analysis to support
bioequivalence (BE) assessment for orally administered immediate-
release solid oral dosage forms, such as tablets, capsules, and
granules/powders for oral suspension. The draft guidance is intended to
provide globally harmonized scientific recommendations for conducting
BE studies during both development and postapproval phases for these
products.

DATES: Submit either electronic or written comments on the draft
guidance by April 3, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-0093 for ``M13A Bioequivalence for Immediate-Release Solid
Oral Dosage Forms.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-

0002, or the Office of Communication, Outreach and Development, Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Lei K. Zhang, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4724, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``M13A Bioequivalence for Immediate-Release Solid Oral Dosage
Forms.'' The draft guidance was prepared under the auspices of ICH. ICH
has the mission of achieving greater regulatory harmonization worldwide
to ensure that safe, effective, high-quality medicines are developed,
registered, and maintained in the most resource-efficient manner. By
harmonizing the regulatory requirements in regions around the world,
ICH guidelines have substantially reduced duplicative clinical studies,
prevented unnecessary animal studies, standardized the reporting of
important safety information, standardized marketing application
submissions, and made many other improvements in the quality of global
drug development and manufacturing and the products available to
patients.
    The six Founding Members of ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each ICH guideline, which FDA then adopts and issues
as guidance for industry. FDA's guidance documents do not establish
legally enforceable responsibilities. Instead, they describe the
Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    On December 20, 2022, the ICH Assembly endorsed the draft guideline
entitled ``M13A Bioequivalence for Immediate-Release Solid Oral Dosage
Forms'' and agreed that the guideline should be made available for
public comment. The draft guideline is the product of the
Multidisciplinary Expert Working Group (M13) of ICH. Comments about
this draft will be considered by FDA and the M13 Expert Working Group.
    The draft guidance describes the scientific and technical aspects
of study design and data analysis to support BE assessment for orally
administered immediate-release solid oral dosage forms such as tablets,
capsules, and granules/powders for oral suspension. The draft guidance
is intended to provide globally harmonized scientific recommendations
for conducting BE studies during both development and postapproval
phases that can increase the efficiency of drug development and
accelerate the availability of safe and effective orally administered
immediate-release solid oral dosage forms.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``M13A Bioequivalence for Immediate-Release
Solid Oral Dosage Forms.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 314.94 for content and format for BE studies
submitted under abbreviated new drug applications have been approved
under OMB control number 0910-0001. The collections of information for
the implementation of improved quality and integrity of the study data
approaches pertaining to good clinical practice have been approved
under OMB control number 0910-0843.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02106 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P


           Notes from Meeting with Environmental Technology Council

Attended by:
ETC Staff:		David Case, James Williams

ETC Members:	Scott Kuhn (Clean Harbors), Bob Garner (Veolia), Tom Baker (Veolia), Nick Maoloni (Ross Environmental), Steve Naylor (EnviroSAFE), Armand Johnson, and others

EPA Staff:	Kristin Fitzgerald, Jessica Young, Lisa Lauer

Date:			October 20, 2011

EPA met with representatives and members of Environmental Technology Council (ETC) to discuss their comments on the Universal Waste proposal in more detail and to provide an update on the pharmaceuticals proposed rule.

ETC indicated that pharmaceuticals that are hazardous due to metal content have enough organics that they may be combusted.

ETC also discussed the intersection of RCRA and DEA regulations.