1 Ethics Review of Ethics Review of AHETF Template Protocol AHETF Template Protocol and Study Protocols and Study Protocols John M. Carley 2 Summary Summary

The AHETF template protocol is a true template into which values are substituted to develop an executable protocol

Specific protocols follow the template very closely

Primary focus of this ethics review is on the template protocol

Most comments apply to all AHETF protocols

A few comments are specific to the individual study protocols 3 AHETF Framework AHETF Framework  1 1. Value  AHETF studies will enhance the completeness and accuracy of the database EPA uses to assess handler exposure in agriculture  Reliable data about dermal and inhalation exposure of workers who handle agricultural pesticides can improve the quality of EPA risk assessments and support appropriately protective regulation  Use of standardized scenarios, methods, and surrogate chemicals permits broad extrapolation of results 2. Scientific Validity: Defer to others 4 AHETF Framework AHETF Framework  2 3. Subject Selection  Subjects are workers with specific experience in the tasks to be performed  Pregnant women and children are excluded  Subjects are recruited through their employers  growers or providers of pesticide application services  IRB required   extra care in the consent process to avoid any coercion or undue influence to participate in the research

 The protocols do not specify how this extra care will be ensured 5 AHETF Framework AHETF Framework  3 4. Risk Benefit Ratio  Exposures measured for workers doing their usual job the usual way  Negligible increase in risk to subjects  if any  for pesticide exposure  Some increase in risk of heat induced illness  Discussion of expected benefits of each study and to whom they would accrue is limited but acceptable  No discussion of how expected benefits weigh against the potential risks to subjects  Subjects are paid $ 100/ day 6 AHETF Framework AHETF Framework  4 5. Independent Ethics Review  Individual protocols reviewed and approved by Western Institutional Review Board, Inc., of Olympia WA  WIRB is registered with OHRP and is independent of the investigators  Approvals conditioned on " extra care" in recruitment and consent process to minimize coercion or undue influence 7 AHETF Framework AHETF Framework  5 6. Informed Consent

Protocol promises to obtain informed consent of all subjects

Protocol is silent about the circumstances and procedures for informing potential subjects and seeking their consent, and the   extra care  called for by WIRB

Informed Consent document is included for each specific protocol,

in English only

Investigator requested Spanish translation from WIRB for AHE 38 7. Respect for Subjects

Subject privacy would not be compromised

Subjects would be free to withdraw 8 Applicable Standards Applicable Standards

These are 3rd party studies intended for submission to EPA under the pesticide laws.

They may involve intentional exposure.

The applicable standards are:

 40 CFR 26, Subparts K and L  FIFRA § 12( a)( 2)( P)

 In some cases, California Code of Regulations Title 3,

Section 6710 9 Deficiencies Noted Deficiencies Noted  1   All protocols should acknowledge the applicable ethical standards, and the investigators' obligation to report any amendments to or deviations from the approved protocol to the cognizant IRB and, if the research is conducted in California, to the California Department of Pesticide Regulation 10 Deficiencies Noted Deficiencies Noted  2   The meaning of the reference in section 5.3 of the protocol to exclusion of subjects with a conflict of interest is unclear, and no mention of conflict of interest is made in the Informed Consent ( IC) materials.

  Section 5.3 of the protocol promises a description of the " worker selection process"

for IRB review. It does not appear to be present. 11 Deficiencies Noted Deficiencies Noted  3   The Informed Consent materials should include a statement about the pesticide use pattern involved in the study, as is provided in section 5.6. b of the protocol.

  The MSDS and label should be made available to the subjects as well as to the investigators,

as promised in section 5.6. c of the protocol. 12 Deficiencies Noted Deficiencies Noted  4

The provision in section 5.9 for altering dilution or application rates to extend the time of exposure may make the exposure scenario atypical or inconsistent with the label, and could undermine the justification for the research. Investigators should ensure that plots selected for treatment in the research are large enough to meet the design requirement for at least 4 hours exposure. 13 Deficiencies Noted Deficiencies Noted  5

Sections 8.1 and 12 of the protocol should acknowledge the requirement to fully document the ethical conduct of the research consistent with 40 CFR 26.1303, including:

 the recruiting process ( and the " extra care" required by the IRB)

 informing potential subjects  obtaining subject consent  reporting deviations or amendments  reporting any adverse events 14 Deficiencies Noted Deficiencies Noted  6

The generic statement of purpose in the template is inadequately informative for the Informed Consent materials in specific studies, which should specify:

the formulation and the active ingredient( s) of the pesticide

the site to which it will be applied

the equipment that will be used

Subjects should be told they are being asked to participate because they are experienced at performing those activities as part of their job 15 Deficiencies Noted Deficiencies Noted  7   A bullet for state government agencies should be added under the heading of " Confidentiality" to the list of organizations which may see personal information, particularly when research is conducted in California.

The relationship between " Payment for Participation"

and " Voluntary Participation/ Withdrawal" is not clear in the Informed Consent material. Would a subject withdrawing early from the research be entitled to full payment? 16 Deficiencies Noted Deficiencies Noted  8

The discussion of " Compensation for Injury" in the Informed Consent material promises to pay for treatment of injuries resulting from being in the study, but excludes injuries " resulting from your normal activities." Since the studies are designed to measure exposure of workers while they perform their normal activities, this exclusion is unacceptable exculpatory language.

It would be appropriate to translate the generic Informed Consent materials into Spanish, and perhaps into other languages as well. 17 Specific Comments Specific Comments

AHE 34: Closed System Mixing and Loading of Liquid Malathion in California  " Investigator's Confirmation of Board Requirements"

form provided by the WIRB is not signed

AHE 36: Airblast Application of Malathion to Grapes in California  On p. 7 the protocol says there will be 13 " replicates"; on page 14 the protocol says there will be 9 " workers ( or replicates)" 18 Specific Comments Specific Comments

AHE 37: Airblast Application of Diazinon to Grapes in New York  On p. 7 the protocol says there will be 13   replicates ; on page 14 the protocol says there will be 9   workers ( or replicates)

AHE 38: Closed Cab Airblast Application of Carbaryl to Orchards in Georgia  Item 36 in the application to the WIRB requests a Spanish translation of the IC materials. No translation was included in the submitted package.

   Investigator s Confirmation of Board Requirements  form provided by the WIRB is not signed 19 Charge Questions Charge Questions

Is this proposed research likely to generate scientifically reliable data, useful for assessing the exposure received by agricultural pesticide handlers?

Does this proposed research appear to comport with the applicable requirements of 40 CFR part 26, subparts K and L?


[Federal Register Volume 82, Number 62 (Monday, April 3, 2017)]
[Notices]
[Pages 16191-16194]
[FR Doc No: 2017-06420]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC17-9-000]

Commission Information Collection Activities (FERC-510, FERC-520,
FERC-561, and FERC-583); Consolidated Comment Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collections and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the requirements and burden of
the information collections described below.

DATES: Comments on the collections of information are due June 2, 2017.

ADDRESSES: You may submit comments (identified by Docket No. IC17-9-
000) by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.

    Please reference the specific collection number and/or title in
your comments.

    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Type of Request: Three-year extension of the information collection
requirements for all collections described below with no changes to the
current reporting requirements. Please note that each collection is
distinct from the next.
    Comments: Comments are invited on: (1) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information will have
practical utility; (2) the accuracy of the agency's estimates of the
burden and cost of the collections of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility and clarity of the information collections; and
(4) ways to minimize the burden of the collections of information on
those who are to respond, including the use of automated collection
techniques or other forms of information technology.

FERC-510 [Application for Surrender of a Hydropower License]

OMB Control No.: 1902-0068

    Abstract: The information collected under the requirements of FERC-
510 is used by the Commission to implement the statutory provisions of
sections 4(e), 6 and 13 of the Federal Power Act (FPA) (16 U.S.C.
797(e), 799, and 806). Section 4(e) gives the Commission authority to
issue licenses for the purposes of constructing, operating and
maintaining dams, water conduits, reservoirs, powerhouses, transmission
lines or other power project works necessary or convenient for
developing and improving navigation, transmission and utilization of
power using bodies of water over which Congress has jurisdiction.
Section 6 gives the Commission the authority to prescribe the
conditions of licenses including the revocation or surrender of the
license. Section 13 defines the Commission's authority to delegate time
periods for when a license must be terminated if project construction
has not begun. Surrender of a license may be desired by a licensee when
a licensed project is retired or not constructed or natural
catastrophes have damaged or destroyed the project facilities.
    FERC-510 is the application for the surrender of a hydropower
license. The information is used by Commission staff to determine the
broad impact of such surrender. The Commission will issue a notice
soliciting comments from the public and other agencies and conduct a
careful review of the application before issuing an order for Surrender
of a License. The order is the result of an analysis of the information
produced (i.e., dam safety, public safety, and environmental concerns,
etc.), which is examined to determine whether any conditions must be
satisfied before granting the surrender. The order implements the
existing regulations and is inclusive for surrender of all types of
hydropower licenses issued by FERC and its predecessor, the Federal
Power Commission. The Commission implements these mandatory filing
requirements in the Code of Federal Regulations (CFR) under 18 CFR 6.1
through 6.4.
    Type of Respondent: Private or Municipal Hydropower Licensees.
    Estimate of Annual Burden: \1\ The Commission estimates the total
annual burden and cost \2\ for this information collection as follows:
---------------------------------------------------------------------------

    \1\ ``Burden'' is 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. For additional
information, refer to Title 5 Code of Federal Regulations 1320.3.
    \2\ The Commission staff thinks that the average respondent for
this collection is similarly situated to the Commission, in terms of
salary plus benefits. Based upon FERC's 2017 annual average of
$158,754 (for salary plus benefits), the average hourly cost is
$76.50/hour.

                                               FERC-510 Application for Surrender of a Hydropower License
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Annual number
       Number of respondents          of responses    Total number      Average burden and cost  per      Total annual burden hours and      Cost per
                                     per respondent   of responses                response                      total annual cost         respondent ($)
(1)                                             (2)     (1) * (2) =  (4)..............................  (3) * (4) = (5).................       (5) / (1)
                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
14.................................               1              14  80 hrs.; \3\ $6,120..............  1,120 hrs.; $85,680.............          $6,120
--------------------------------------------------------------------------------------------------------------------------------------------------------

FERC-520 [Application for Authority To Hold Interlocking Directorate
Positions]

OMB Control No.: 1902-0083

    Abstract: The Federal Power Act (FPA), as amended by the Public
Utility Regulatory Policies Act of 1978 (PURPA), mandates federal
oversight and approval of certain electric corporate activities to
ensure that neither public nor private interests are adversely
affected. Accordingly, the FPA proscribes related information filing
requirements to achieve this goal. Such filing requirements are found
in the Code of Federal Regulations (CFR), specifically in 18 CFR part
45, and serve as the basis for FERC-520.
---------------------------------------------------------------------------

    \3\ Based on additional information, we are revising the
estimated average burden per response to 80 hours (rather than 10
hours). The reporting requirements have not changed.
---------------------------------------------------------------------------

    FERC-520 is divided into two types of applications: Full and
informational. The full application, as specified in 18 CFR 45.8,
implements the FPA requirement under section 305(b) that it is unlawful
for any person to concurrently hold the positions of officer or
director of more than one public utility; or a public utility and a
financial institution that is authorized to underwrite or participate
in the marketing of public utility securities; or a public utility and
an electrical equipment supplier to that public utility, unless
authorized by order of the Commission. In order to obtain
authorization, an applicant must demonstrate that neither public nor
private interests will be adversely affected by the holding of the
position. The full application provides the

Commission with information about any interlocking position for which
the applicant seeks authorization including, but not limited to, a
description of duties and the estimated time devoted to the position.
    An informational application, specified in 18 CFR 45.9, allows an
applicant to receive automatic authorization for an interlocked
position upon receipt of the filing by the Commission. The
informational application applies only to those individuals who seek
authorization as: (1) An officer or director of two or more public
utilities where the same holding company owns, directly or indirectly,
that percentage of each utility's stock (of whatever class or classes)
which is required by each utility's by-laws to elect directors; (2) an
officer or director of two public utilities, if one utility is owned,
wholly or in part, by the other and, as its primary business, owns or
operates transmission or generation facilities to provide transmission
service or electric power for sale to its owners; or (3) an officer or
director of more than one public utility, if such person is already
authorized under part 45 to hold different positions as officer or
director of those utilities where the interlock involves affiliated
public utilities.
    Pursuant to 18 CFR 45.5, in the event that an applicant resigns or
withdraws from Commission-authorized interlocked positions or is not
re-elected or re-appointed to such interlocked positions, the
Commission requires that the applicant submit a notice of change within
30 days from the date of the change.
    Type of Respondents: Individuals who plan to concurrently become
officers or directors of public utilities and of certain other covered
entities must request authorization to hold such interlocking positions
by submitting a FERC-520.
    Estimate of Annual Burden: \1\ The Commission estimates the total
annual burden and cost \2\ for this information collection as follows:

                                      FERC-520 Application for Authority To Hold Interlocking Directorate Positions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Annual  number                                                                               Cost per
                                   Number of     of  responses   Total number     Average  burden and cost    Total annual  burden hours    respondent
                                  respondents   per respondent   of responses           per response             (total annual cost)            ($)
                                           (1)             (2)     (1) * (2) =  (4)                          (3) * (4) = (5)                   (5) / (1)
                                                                           (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Full..........................              16               1              16  50 hrs.; $3,825............  800 hrs.; $61,200..........          $3,825
Informational.................             500               1             500  8 hrs.; $612...............  4,000 hrs.; $306,000.......             612
Notice of Change..............             200               1             200  0.25 hrs.; $19.13..........  50 hrs.; $3,825............           19.13
                               -------------------------------------------------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ...........................  4,850 hrs.; $371,025.......  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

FERC-561 [Annual Report of Interlocking Positions]

OMB Control No.: 1902-0099

    Abstract: The FERC Form 561 responds to the FPA requirements for
annual reporting of similar types of positions which public utility
officers and directors hold with financial institutions, insurance
companies, utility equipment and fuel providers, and with any of an
electric utility's 20 largest purchasers of electric energy (i.e., the
20 entities with high expenditures of electricity). The FPA
specifically defines most of the information elements in the Form 561
including the information that must be filed, the required filers, the
directive to make the information available to the public, and the
filing deadline.
    The Commission uses the information required by 18 CFR 131.31 and
collected by the Form 561 to implement the FPA requirement that those
who are authorized to hold interlocked directorates annually disclose
all the interlocked positions held within the prior year. The Form 561
data identifies persons holding interlocking positions between public
utilities and other entities, allows the Commission to review these
interlocking positions, and allows identification of possible conflicts
of interest.
    Type of Respondents: Public utility officers and directors holding
financial positions, insurance companies, security underwriters,
electrical equipment suppliers, fuel provider, and any entity which is
controlled by these.
    Estimate of Annual Burden: \1\ The Commission estimates the total
annual burden and cost \2\ for this information collection as follows:

                                                 FERC Form 561--Annual Report of Interlocking Positions
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                                     Annual  number
                                      of  responses   Total number     Average  burden and cost  per     Total annual  burden hours and      Cost per
       Number of respondents               per        of responses                response                     total  annual cost         respondent ($)
                                       respondent
(1)                                             (2)     (1) * (2) =  (4)..............................  (3) * (4) = (5).................       (5) / (1)
                                                                (3)
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2,700..............................               1           2,700  0.25 hrs.; $19.13................  675.00 hrs.; $51,637.50.........          $19.13
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FERC-583 [Annual Kilowatt Generating Report (Annual Charges)]

OMB Control No.: 1902-0136

    Abstract: The FERC-583 is used by the Commission to implement the
statutory provisions of section 10(e) of the Federal Power Act (FPA)
(16 U.S.C. 803(e)), which requires the Commission to collect annual
charges from hydropower licensees for, among other things, the cost of
administering part I of the FPA and for the use of United States dams.
In addition, section 3401 of the Omnibus Budget Reconciliation Act of
1986 (OBRA) authorizes the Commission to ``assess and collect fees and
annual charges in any fiscal year in amounts equal to all of the costs
incurred by the Commission in that fiscal year.'' The information is

collected annually and used to determine the amounts of the annual
charges to be assessed licensees for reimbursable government
administrative costs and for the use of government dams. The Commission
implements these filing requirements in the Code of Federal Regulations
(CFR) under 18 CFR part 11.1 through 11.8.\4\
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    \4\ As discussed in 18 CFR part 11, selected federal agencies
(such as the United States Fish and Wildlife Service and the
National Marine Fisheries Service) submit annual reports to the
Commission on their federal costs in administering part I of the
Federal Power Act. The filing requirements imposed on those federal
agencies are not collected for general statistical purposes and are
not a ``collection of information'' as defined by 5 CFR
1320.3(c)(3). (The form and additional information on the
information provided by those agencies is posted at https://www.ferc.gov/docs-filing/forms.asp#ofa.)
---------------------------------------------------------------------------

    Type of Respondent: FERC-regulated private and public hydropower
licensees.
    Estimate of Annual Burden: \1\ The Commission estimates the total
annual burden and cost \2\ for this information collection as follows:

                                                       FERC-583--Annual Kilowatt Generating Report
                                                                    [Annual Charges]
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                                     Annual  number
                                      of  responses   Total number     Average  burden and cost  per     Total annual  burden hours  and     Cost per
     Number of respondents \5\             per        of responses                response                     total  annual cost         respondent ($)
                                       respondent
(1)                                             (2)     (1) * (2) =  (4)..............................  (3) * (4) = (5).................       (5) / (1)
                                                                (3)
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520................................               1             520  2 hrs.; $153.....................  1,040 hrs.; $79,560.............            $153
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    Dated: March 24, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06420 Filed 3-31-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: January 27, 2010 (Volume 75, Number 17)]
[Notices]
[Page 4407]
[DOCID:fr27ja10-100]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Science Board to the Food and Drug Administration; Notice of
Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Science Board to the Food and Drug
Administration (Science Board).
    General Function of the Committee: The Science Board provides
advice primarily to the Commissioner of Food and Drugs and other
appropriate officials on specific complex and technical issues, as well
as emerging issues within the scientific community in industry and
academia. Additionally, the Science Board provides advice to the agency
on keeping pace with technical and scientific evolutions in the fields
of regulatory science, on formulating an appropriate research agenda,
and on upgrading its scientific and research facilities to keep pace
with these changes. It will also provide the means for critical review
of agency sponsored intramural and extramural scientific research
programs.
    Date and Time: The meeting will be held on Monday, February 22,
2010, from 8 a.m. to 3 p.m.
    Addresses: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD
20814.
    Contact Person: Doreen Kezer, Office of the Commissioner (HF-33),
Food and Drug Administration, 5600 Fishers Lane, rm. 14-65, Rockville,
MD 20857,<PHONE_NUMBER>, or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512603. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: On February 22, 2010, the Science Board will hear about and
discuss an interim report from its subcommittee reviewing research at
the Center for Food Safety and Applied Nutrition. The Science Board
will also hear about and discuss plans to establish another
subcommittee to review research programs at the Center for Drug
Evaluation and Research. The Science Board will then hear and discuss
updates on science programs at the Office of Regulatory Affairs and the
National Center for Toxicological Research.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
Monday, February 15, 2010. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those desiring to
make formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before Friday, February 5, 2010. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by Monday, February 8, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Doreen Kezer at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 19, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-1520 Filed 1-26-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 208 (Thursday, October 27, 2016)]
[Proposed Rules]
[Pages 74750-74753]
[FR Doc No: 2016-25803]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2016-0520; FRL-9952-65-Region 6]

Approval and Promulgation of Implementation Plans; Louisiana;
Regional Haze State Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Louisiana State Implementation Plan (SIP)
submitted by the State of Louisiana through the Louisiana Department of
Environmental Quality (LDEQ) on August 11, 2016 that addresses regional
haze (RH) for the first planning period. This revision was submitted to
address deficiencies identified in a previous action regarding
requirements of the Federal Clean Air Act (CAA or Act) and the EPA's
rules that require states to prevent any future and remedy any existing
man-made impairment of visibility in mandatory Class I areas caused by
emissions of air pollutants from numerous sources located over a wide
geographic area (also referred to as the ``regional haze program'').
This action concerns Best Available Retrofit Technology for certain
sources.

DATES: Written comments must be received on or before November 28,
2016.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2016-0520, at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the Web, cloud, or other file sharing system). For
additional submission methods, please contact Jennifer Huser, 214-665-
7347<EMAIL_ADDRESS>For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at the EPA
Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available at either location
(e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Jennifer Huser,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Jennifer Huser or Mr. Bill Deese at 214-
665-7253.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

A. The Regional Haze Program

    In the Clean Air Act (CAA) Amendments of 1977, Congress established
a program to protect and improve visibility in the Nation's national
parks and wilderness areas. See CAA section 169A. Congress amended the
visibility provisions in the CAA in 1990 to focus attention on the
problem of regional haze. See CAA section 169B. The EPA promulgated
regional haze regulations in 1999 to implement sections 169A and 169B
of the CAA. These regulations require states to develop and implement
plans to ensure reasonable progress toward improving visibility in
mandatory Class I Federal areas \1\ (Class I areas). See 64 FR 35714
(July 1, 1999); see also 70 FR 39104 (July 6, 2005) and 71 FR 60612
(October 13, 2006).
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    \1\ Areas designated as mandatory Class I Federal areas consist
of national parks exceeding 6,000 acres, wilderness areas and
national memorial parks exceeding 5,000 acres, and all international
parks that were in existence on August 7, 1977. 42 U.S.C. 7472(a).
In accordance with section 169A of the CAA, the EPA, in consultation
with the Department of Interior, promulgated a list of 156 areas
where visibility is identified as an important value. 44 FR 69122
(November 30, 1979). The extent of a mandatory Class I area includes
subsequent changes in boundaries, such as park expansions. 42 U.S.C.
7472(a). Although states and tribes may designate as Class I
additional areas which they consider to have visibility as an
important value, the requirements of the visibility program set
forth in section 169A of the CAA apply only to ``mandatory Class I
Federal areas.'' Each mandatory Class I Federal area is the
responsibility of a ``Federal Land Manager.'' 42 U.S.C. 7602(i).
When we use the term ``Class I area'' in this action, we mean a
``mandatory Class I Federal area.''
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    Regional haze is impairment of visual range or colorization caused
by air pollution, principally fine particulate, produced by numerous
sources and activities, located across a broad regional area. The
sources include but are not limited to, major and minor stationary
sources, mobile sources, and area sources including non-anthropogenic
sources. These sources and activities may emit fine particles (PM
2.5) (e.g., sulfates, nitrates, organic carbon, elemental
carbon, and soil dust), and their precursors (e.g., sulfur dioxide
(SO2), nitrogen oxides (NOX), and in some cases,
ammonia and volatile organic compounds). Fine particulate can also
cause serious health effects and mortality in humans, and contributes
to environmental effects such as acid deposition and eutrophication.
See 64 FR at 35715. Data from the existing visibility monitoring
network, the ``Interagency Monitoring of Protected Visual
Environments'' (IMPROVE) monitoring network, show that visibility
impairment caused by air pollution occurs virtually all the time in
most national parks and wilderness areas. The average visual range in
many Class I areas in the western United States is 100-150 kilometers,
or about one-half to two-thirds the visual range that would exist
without manmade air pollution.\2\ Visibility impairment also varies
day-to-day and by season depending on variations in meteorology and
emission rates. The deciview (dv) is the metric by which visibility is
measured in the regional haze program. A change of 1 dv is generally
considered the change in visual range that the human eye can perceive.
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    \2\ 64 FR at 35715.
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B. Best Available Retrofit Technology

    Section 169A of the CAA directs states to evaluate the use of
retrofit controls at certain larger, often uncontrolled, older
stationary sources with the potential to emit greater than 250 tons per
year (tpy) or more of any visibility impairing pollutant in order to
address visibility impacts from these sources. Specifically, section
169A(b)(2)(A) of the Act requires states to revise their SIPs to
contain such measures as may be necessary to make

reasonable progress towards the natural visibility goal, including a
requirement that certain categories of existing major stationary
sources \3\ built between 1962 and 1977 procure, install, and operate
the ``Best Available Retrofit Technology'', as determined by the state
or us in the case of a plan promulgated under section 110(c) of the
CAA. Under the Regional Haze rule, states are directed to conduct BART
determinations for such ``BART-eligible'' sources that may be
anticipated to cause or contribute to any visibility impairment in a
Class I area.
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    \3\ The set of ``major stationary sources'' potentially subject
to BART are listed in CAA section 169A(g)(7).
---------------------------------------------------------------------------

    We promulgated regulations addressing Regional Haze in 1999, 64 FR
35714 (July 1, 1999), codified at 40 CFR part 51, subpart P.\4\ These
regulations require all states to submit implementation plans that,
among other measures, contain either emission limits representing BART
for certain sources constructed between 1962 and 1977, or alternative
measures that provide for greater reasonable progress than BART. 40 CFR
51.308(e).
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    \4\ In American Corn Growers Ass'n v. EPA, 291 F.3d 1 (D.C. Cir.
2002), the U.S. Court of Appeals for the District of Columbia
Circuit issued a ruling vacating and remanding the BART provisions
of the regional haze rule. In 2005, we issued BART guidelines to
address the court's ruling in that case. See 70 FR 39104 (July 6,
2005).
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C. EPA's Previous Actions on Louisiana Regional Haze

    On June 13, 2008, Louisiana submitted a SIP to address regional
haze. EPA acted on that submittal in two separate actions. The first
was a limited disapproval (77 FR 33641) because of deficiencies in the
state's regional haze SIP submittal arising from the remand by the U.S.
Court of Appeals for the District of Columbia to the EPA of the Clean
Air Interstate Rule (CAIR). The second was a partial limited approval/
partial disapproval (77 FR 39425) because the SIP revision met some but
not all of the applicable requirements of the CAA and EPA's regulations
as set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300-
308, but as a whole, the SIP revision strengthened the SIP. The
deficiencies included inadequate Best Available Retrofit Technology
(BART) determinations for four facilities. These four facilities are
the only non-electric generating unit (EGU) facilities in Louisiana
that were identified as being subject to BART and are referred to as
the non-EGU facilities.
    On August 11 2016, Louisiana submitted a SIP revision intended to
address the deficiencies related to BART for the four non-EGUs.

II. The EPA's Evaluation

A. Introduction to the Four Non-EGU Facilities: Summary

    The four non-EGU facilities are: Phillips 66 Company-Alliance
Refinery; Mosaic Fertilizer LLC, Uncle Sam Plant; Eco-Services
Operations Corp.; and Sid Richardson Carbon Co., Addis Plant. For three
facilities (Phillips 66, Eco-Services, and Sid Richardson), LDEQ had
submitted a BART analysis under 40 CFR 51.308(e)(1)(ii)(A). For each of
these facilities, we determined, in our July 3, 2012 notice, that the
BART analysis satisfied part, but not all, of the requirements. We also
found that LDEQ had erred in exempting Mosaic from BART by using future
controls and visibility impacts rather than assessing controls that
were in place at the time of the SIP submittal.
    In its August 11, 2016 SIP submittal, LDEQ provided revised BART
analyses for the three facilities to address the deficiencies noted in
the previous Regional Haze SIP action. LDEQ has also provided a BART
analysis for Mosaic. A summary of our proposed findings for these
facilities is provided below. For more details, please see our
evaluation of the BART determination for each of these four subject-to-
BART sources in the TSD.
A. Sid Richardson Carbon Co.
    The Sid Richardson Carbon Company's Addis Plant is located in West
Baton Rouge Parish, Louisiana. For the BART eligible units at the
facility, LDEQ submitted in the original Regional Haze SIP a BART
engineering analysis; for particulate matter the LDEQ determined that
the high efficiency fabric filters already in use at the facility are
BART. EPA found that the LDEQ acted within its discretion in making
this determination and that the analyses met the BART requirements.
However, the EPA found that the BART analysis for NOX and
SO2 were deficient. While LDEQ indicated that no controls
were technically feasible, EPA found that the record did not provide a
sufficient basis for this conclusion. Based on this, the NOX
and SO2 BART determination for the Addis Plant was deemed
deficient (77 FR 11851).
    The original modeling that was performed showed that the facility
had an impact that was above the contribution threshold of 0.5 deciview
level for determining which sources are subject to BART. The Addis
plant model results were 0.756 deciviews.
    In response to the EPA action, Sid Richardson revised the BART
analysis and updated the modeling. The facility requested permission to
perform a new round of modeling using the same emissions parameters
that were used in the original model but utilizing the newest EPA
approved methods and guidance documents. EPA reviewed and concurred
with the methodology and modeling results provided by Sid Richardson.
Based on this analysis, LDEQ concluded that the facility is not
subject-to-BART because its model visibility impact was less than 0.5
deciviews. We have evaluated LDEQ's submittal and propose to approve
the Sid Richardson BART analysis and modeling and the LDEQ's finding
that the Addis plant is not subject-to-BART.
B. Phillips 66 Company-Alliance Refinery (Formerly ConocoPhillips)
    The Phillips 66 Company (Phillips 66) owns and operates the
Alliance Refinery near Belle Chasse, Louisiana, which is a subject-to-
BART source.\5\ On December 5, 2005, Conoco Phillips, the United States
of America and the State of Louisiana, entered into a Consent Decree
(CD) \6\ as part of the National Refinery Initiative for the Belle
Chasse (Alliance) Refinery. In our previous action, we found that the
BART engineering analysis provided by Phillips 66 utilized emission
reductions that are mandated per the CD for the fluidized catalytic
cracker (FCCU), the process refinery flares and the crude unit heater.
However, the LDEQ did not provide a complete BART evaluation for these
units. In the August 11, 2016 SIP revision, LDEQ provided a complete
BART determination for these units. Controls and conditions required by
the CD include a wet gas scrubber on the FCCU, selective catalytic
reduction (SCR) on the FCCU and crude unit heater, flare gas recovery
for the process refinery flares, and compliance with the Standards of
Performance for Petroleum Refineries as prescribed in 40 CFR part 60,
subpart J for the low pressure and high pressure flares, CO boilers,
and crude unit heaters. Implementation of these control projects as per
the CD emissions reduction requirements have resulted in reducing the
overall site visibility impacts. In the previous

action, we also found that the LDEQ failed to submit the emissions
limits as part of the SIP revision as required. The emissions limits
are now included in an Administrative Order on Consent (AOC) No. AE-
AOC-14-00211A between LDEQ and Phillips 66 and were provided in the
August 11, 2016 SIP revision.
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    \5\ At the time of Louisiana's initial Regional Haze SIP, the
Alliance Refinery was owned and operated by ConocoPhillips.
Ownership of the Alliance Refinery transferred to Phillips 66 on
April 26, 2012. Pursuant to the Separation and Distribution
Agreement between the companies, responsibility for compliance with
the environmental permits now resides with Phillips 66 Company.
    \6\ Civil Action No. H-05-0285. A copy of this CD is available
in the docket for this rulemaking.
---------------------------------------------------------------------------

    In our initial action on Louisiana Regional Haze, we approved
LDEQ's BART determinations for several other subject to BART units at
the Alliance Refinery. These units include the cooling water tower,
gas-fired heaters, loading docks, and the coke transfer and storage
area. See 77 FR at 39432. However, at that time, LDEQ did not submit
the BART emissions limits for approval into the SIP. The BART emissions
limits for these units are also included in AOC No. AE-AOC-14-00211A.
    EPA proposes to find that the current controls installed and
operating conditions at these subject to BART units constitute BART.
The emissions limits for all of the subject to BART units at the
Alliance Refinery are included in the AOC in accordance with 40 CFR
51.308(4)(e). Upon EPA approval of this portion of the Regional Haze
SIP submittal, the AOC becomes federally enforceable. We propose to
approve the BART analysis and the emission limits for Phillips 66 as
meeting the BART requirements.
C. Mosaic Fertilizer LLC
    Mosaic Fertilizer, LLC, owns and operates the Uncle Sam Plant
(Mosaic) in St. James Parish, Louisiana and produces phosphoric acid
and sulfuric acid. In our previous action, we partially disapproved
Louisiana's Regional Haze SIP for failure to identify Mosaic as subject
to BART and failure to submit a BART determination for Mosaic.
    In Louisiana's initial Regional Haze SIP submittal, the LDEQ used a
contribution threshold of 0.5 dv for determining which sources are
subject to BART, and we approved this threshold in our previous action.
See, 77 FR at 11849. The Regional Haze Rule states that a BART eligible
source can only be exempted from being subject to BART if its
visibility impacts at the time the SIP is developed are less than the
screening value. See, 70 FR 39118; 77 FR at 11849.
    In the original Regional Haze SIP submittal, the LDEQ properly
identified Mosaic as a BART eligible source consistent with the BART
Guidelines. However, LDEQ's initial SIP submittal inappropriately
allowed Mosaic to screen out based on controls that were not installed
at the time of the submittal. LDEQ accepted Mosaic's modeling, which
was based on future controls that were to be installed on the A-Train
Sulfuric Acid Stack. Based on the modeling results, the LDEQ listed the
facility as passing both the screening modeling as well as the refined
modeling. As such, LDEQ erroneously determined that the facility was
not subject to BART and, therefore, was not required to perform a BART
analysis.
    In our final action (77 FR at 39429), we determined that the state
should have identified the Mosaic facility as being subject to BART and
submitted a BART determination for the source. Mosaic entered into a CD
with the EPA, LDEQ and other parties on December 23, 2009.\7\ The CD
required the installation of controls on the Sulfuric Acid Trains A, D,
and E, including a scrubber system on the A Train and process
improvements on the D Train. These controls resulted in a reduction in
SO2 emissions of over 10,000 tons per year. In its SIP
revision, LDEQ provided a complete BART analysis concluding that
additional control beyond those required by the consent decree would
not be necessary to meet BART. Based on a review of the BART analysis
and LDEQ's determination, EPA agrees that Mosaic, with its current
controls and operating conditions, has satisfied BART. The emissions
limits for Mosaic under current controls and operating conditions are
included in AOC No. AE-AOC-14-00274A which was included in the August
11, 2016 SIP revision in accordance with 40 CFR 51.308(4)(e). Upon EPA
approval of this portion of the Regional Haze SIP submittal, the AOC
becomes federally enforceable. We propose to approve the BART analysis
and the emission limits for Mosaic.
---------------------------------------------------------------------------

    \7\ Civil Action No. 09-6662. A copy of this CD is available in
the docket for this rulemaking.
---------------------------------------------------------------------------

D. Eco-Services Operations Corp (Formerly Rhodia)
    The Eco-Services Operations Corp facility (Eco-Services) is a
sulfuric acid plant located in Baton Rouge, Louisiana.\8\ The plant
produces sulfuric acid by using two sulfuric acid production trains,
Unit 1 and Unit 2, but only Unit 2 is subject to BART.\9\ Effective
July 23, 2007, the EPA, LDEQ and other parties entered into a CD with
Eco-Services due to violations associated with excess emissions of
sulfuric acid mist and sulfur dioxide. The CD required a scrubber to be
installed on each of the units to control SO2 emissions.\10\
---------------------------------------------------------------------------

    \8\ At the time of Louisiana's initial Regional Haze SIP, the
facility was owned and operated by Rhodia. Effective October 1,
2013, Rhodia Inc. changed its company name and the name of the
facility from Rhodia Inc. to Solvay USA Inc. The LDEQ Office of
Environmental Services acknowledged the name change in
correspondence, dated November 1, 2013. On December 1, 2014, Solvay
USA Inc. transferred ownership and operation of the facility to Eco
Services Operations LLC. Pursuant to the agreement between the
companies and the Department's approval of the permit transfer,
responsibility for compliance with the terms and conditions of
Permit No. 0840-00033-V5 now resides with Eco Services Operations
LLC. Pursuant to the Separation and Distribution Agreement between
the companies, responsibility for compliance with the environmental
permits now resides with Eco-Services.
    \9\ Under the CAA, BART only applies to a unit that was ``in
existence on August 7, 1977, but which has not been in operation for
more than fifteen years as of such date.'' 42 U.S.C. 7491(b)(2)(A);
CAA 169A(b)(2)(A). Unit 1 was constructed in 1953, which is outside
the BART timeframe. However, Unit 2 was constructed in 1968.
    \10\ Civil Action No. 2:07CV134 WL. A copy of this CD is
available in the docket for this rulemaking.
---------------------------------------------------------------------------

    In the July 23, 2012 action (77 FR at 39426), EPA found that with
the selected control strategy, the Eco-Services units met the BART
requirements at 40 CFR part 51, Appendix Y.OV.D.1.9.\11\ However, EPA
found that the LDEQ failed to submit the emissions limits as part of
the SIP revision as required. The emissions limits are included in the
AOC No. AE-AOC-14-00957 between LDEQ and Eco-Services, which was
provided in the August 11, 2016 SIP revision.
---------------------------------------------------------------------------

    \11\ We acknowledge that compliance with the BART Guidelines in
40 CFR part 51, Appendix Y is not mandatory for Eco-Services because
Eco-Services is a non-EGU source. However, following these
Guidelines is one option for subject-to-BART non-EGUs to ensure BART
determinations are adequate.
---------------------------------------------------------------------------

    In the BART analysis, Eco-Services identified both a short term and
long term limit control level for SO2. The long term
emissions limits for Eco-Services under current controls and operating
conditions are included in the AOC in accordance with 40 CFR
51.308(4)(e) and are federally enforceable. The short term limit
provided in the BART analysis is 3 lbs/ton, consistent with the limits
established in the Consent Decree. The long term limit in the Consent
Decree includes an exemption for emissions during startup shutdown and
malfunction. However, the short term emissions are limited by the New
Source Performance Standard (NSPS) for Sulfuric Acid Plants (40 CFR
part 60, subpart H). This short term limit is applicable at all times
and is adequate to meet BART during periods of startup and shutdown.
EPA concurs with LDEQ's evaluation and findings that the current
controls in place, along with the federally enforceable limits
established in the AOC and through applicability to

the NSPS standard, constitutes BART. We propose to approve the BART
analysis and the emission limits for Eco-Services. Upon approval the
limits in the SIP these limits will be federally enforceable.

III. Proposed Action

    We are proposing to approve Louisiana's Regional Haze SIP revision
submitted on August 11, 2016. Specifically, we are proposing to find
that the following elements have satisfied the federal requirement:
     the State's identification of BART-eligible sources,
     the State's determination that Sid Richardson Addis Plant
is not subject to BART,
     the State's BART determinations for Phillips 66, Eco-
Services, and Mosaic.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
dioxides, Visibility, Interstate transport of pollution, Regional haze,
Best available control technology.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: October 11, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-25803 Filed 10-26-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22974-22976]
[FR Doc No: 2018-10568]

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ENVIRONMENTAL PROTECTION AGENCY

[CWA-05-2016-0015; FRL-9978-10-OARM]

Order Denying Petition To Set Aside Consent Agreement and
Proposed Final Order

AGENCY: Office of Administrative Law Judges, Environmental Protection
Agency (EPA).

ACTION: Notice of order denying petition to set aside consent agreement
and proposed final order.

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SUMMARY: In accordance with section 311(b)(6)(C)(iii) of the Clean
Water Act (CWA or Act), notice is hereby given that an Order Denying
Petition to Set Aside Consent Agreement and Proposed Final Order has
been issued in the matter styled as In the Matter of BP Products North
America Inc., Docket No. CWA-05-2016-0015. This document serves to
notify the public of the denial of the Petition to Set Aside Consent
Agreement and Proposed Final Order filed in the matter and explain the
reasons for such denial.

ADDRESSES: To access and review documents filed in the matter that is
the subject of this document, please visit https://yosemite.epa.gov/oarm/alj/alj_web_docket.nsf/Dockets/CWA-05-2016-0015.

FOR FURTHER INFORMATION CONTACT: Jennifer Almase, Attorney-Advisor,
Office of Administrative Law Judges (1900R), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW; telephone number:<PHONE_NUMBER>
(main) or<PHONE_NUMBER> (direct); fax number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Legal Authority

    Section 311(b)(6)(A) of the CWA empowers EPA to assess a class I or
class II administrative civil penalty against any owner, operator, or
person in charge of any onshore facility from which oil or a hazardous
substance is discharged in violation of section 311(b)(3), or who fails
or refuses to comply with any regulation issued under section 311(j) to
which that owner, operator, or person in charge is subject (33 U.S.C.
1321(b)(6)(A)). However, before issuing an order assessing a class II
civil penalty under section 311(b)(6), EPA is required by the CWA and
the Consolidated Rules of Practice Governing the Administrative
Assessment of Civil Penalties and the Revocation/Termination or
Suspension of Permits (Rules of Practice) to provide public notice of
and reasonable

opportunity to comment on the proposed issuance of such order (33
U.S.C. 1321(b)(6)(C)(i); 40 CFR 22.45(b)(1)).
    Any person who comments on the proposed assessment of a class II
civil penalty under section 311(b)(6) is then entitled to receive
notice of any hearing held under section 311(b)(6) of the CWA and at
such hearing is entitled to a reasonable opportunity to be heard and to
present evidence (33 U.S.C. 1321(b)(6)(C)(ii); 40 CFR 22.45(c)(1)). If
no hearing is held before issuance of an order assessing a class II
civil penalty under section 311(b)(6) of the CWA, such as where the
administrative penalty action in question is settled pursuant to a
consent agreement and final order, any person who commented on the
proposed assessment may petition to set aside the order on the basis
that material evidence was not considered and to hold a hearing on the
penalty (33 U.S.C. 1321(b)(6)(C)(iii); 40 CFR 22.45(c)(4)(ii)).
    The CWA requires that if the evidence presented by the petitioner
in support of the petition is material and was not considered in the
issuance of the order, the Administrator shall immediately set aside
such order and provide a hearing in accordance with section
311(b)(6)(B)(ii) (33 U.S.C. 1321(b)(6)(C)(iii)). Conversely, if the
Administrator denies a hearing, the Administrator shall provide to the
petitioner, and publish in the Federal Register, notice of and reasons
for such denial. Id.
    Pursuant to section 311 of the CWA, the authority to decide
petitions by commenters to set aside final orders entered without a
hearing and provide copies and/or notice of the decision has been
delegated to Regional Administrators in administrative penalty actions
brought by regional offices of EPA. Administrator's Delegation of
Authority 2-52A (accessible at: http://intranet.epa.gov/ohr/rmpolicy/ads/dm/2-52A.pdf). The Rules of Practice require that where a commenter
petitions to set aside a consent agreement and final order in an
administrative penalty action brought by a regional office of EPA, the
Regional Administrator shall assign a Petition Officer to consider and
rule on the petition (40 CFR 22.45(c)(4)(iii)). Upon review of the
petition and any response filed by the complainant, the Petition
Officer shall then make written findings as to (A) the extent to which
the petition states an issue relevant and material to the issuance of
the consent agreement and proposed final order; (B) whether the
complainant adequately considered and responded to the petition; and
(C) whether resolution of the proceeding by the parties is appropriate
without a hearing (40 CFR 22.45(c)(4)(v)).
    If the Petition Officer finds that a hearing is appropriate, the
Presiding Officer shall order that the consent agreement and proposed
final order be set aside and establish a schedule for a hearing (40 CFR
22.45(c)(4)(vi)). Conversely, if the Petition Officer finds that
resolution of the proceeding without a hearing is appropriate, the
Petition Officer shall issue an order denying the petition and stating
reasons for the denial (40 CFR 22.45(c)(4)(vii)). The Petition Officer
shall then file the order with the Regional Hearing Clerk, serve copies
of the on the parties and the commenter, and provide public notice of
the order. Id.

II. Procedural Background

    In May of 2016, the Director of the Superfund Division of EPA's
Region 5 (Complainant) and BP Products North America Inc. (Respondent)
executed a Consent Agreement and Final Order (CAFO) in the matter
styled as In the Matter of BP Products North America Inc., Docket No.
CWA-05-2016-0015.\1\ The CAFO sought to simultaneously commence and
conclude an administrative penalty action under section
311(b)(6)(A)(ii) of the CWA against Respondent for alleged violations
related to a discharge of oil from Respondent's petroleum refinery
located at 2815 Indianapolis Boulevard in Whiting, Indiana (Facility),
into Lake Michigan on March 24, 2014. Under the terms of the CAFO,
Respondent admitted the jurisdictional allegations set forth in the
CAFO but neither admitted nor denied the factual allegations and
alleged violations. Nevertheless, Respondent waived its right to a
hearing or to otherwise contest the CAFO, and agreed to pay a civil
penalty in the amount of $151,899.
---------------------------------------------------------------------------

    \1\ While titled ``Consent Agreement and Final Order,'' a final
order was not actually included with the CAFO filed with this
Tribunal. It is the execution of a final order by Region 5's
Regional Administrator, and its subsequent filing with the Regional
Hearing Clerk at Region 5, that will effectuate the parties' Consent
Agreement and conclude the proceeding.
---------------------------------------------------------------------------

    On or about June 1, 2016, EPA provided public notice of its intent
to file the proposed CAFO and accept public comments thereon. Carlotta
Blake-King, Carolyn A. Marsh, Debra Michaud, and Patricia Walter
(Petitioners) timely filed comments on the proposed CAFO (Comments).
Complainant subsequently prepared a Response to Comments Regarding
Proposed CAFO (Response to Comments), which indicated that EPA would
not be altering the proposed CAFO. The Response to Comments was mailed
to Petitioners, together with a copy of the proposed CAFO, on or about
January 17, 2017, and each Petitioner received the materials by January
30, 2017. On or about February 24, 2017, Petitioners timely filed a
joint petition seeking to set aside the proposed CAFO and have a public
hearing held thereon (Petition).
    A Request to Assign Petition Officer (Request) was issued by Region
5's Acting Regional Administrator on May 17, 2017, and served on
Petitioners on May 30, 2017. In the Request, the Acting Regional
Administrator stated that after considering the issues raised in the
Petition, Complainant had decided not to withdraw the CAFO.
Accordingly, the Acting Regional Administrator requested assignment of
an Administrative Law Judge to consider and rule on the Petition
pursuant to Sec.  22.45(c)(4)(iii) of the Rules of Practice, 40 CFR
22.45(c)(4)(iii). By Order dated June 16, 2017, the undersigned was
designated to preside over this matter, and Complainant was directed to
file a response to the Petition. Complainant filed its Response to
Petition to Set Aside Consent Agreement and Proposed Final Order
(Response to Petition) on July 13, 2017.\2\
---------------------------------------------------------------------------

    \2\ Richard C. Karl, who executed the CAFO as Region 5's
Director of the Superfund Division, seemingly left that position by
the time the Acting Regional Administrator issued the Request to
Assign Petition Officer. In the Request, the Acting Regional
Administrator noted that Complainant, the Acting Superfund Division
Director, had decided not to withdraw the CAFO. Subsequently,
Margaret M. Guerriero, as the Acting Director of Region 5's
Superfund Division, submitted the Response to Petition.
---------------------------------------------------------------------------

III. Denial of Petitioners' Petition

    On May 8, 2018, the undersigned issued an Order Denying Petition to
Set Aside Consent Agreement and Proposed Final Order (Order). Therein,
the undersigned denied the Petition without the need for a hearing on
the basis that Petitioners had failed to present any relevant and
material evidence that had not been adequately considered and responded
to by Complainant.
    Specifically, Petitioners raised issues that the undersigned
grouped into four categories.\3\ First, Petitioners argued that the
alleged violations warranted the assessment of the maximum penalty of
$187,500 allowed under the applicable law, suggesting that Complainant
failed

in its penalty calculation to consider material evidence regarding the
magnitude of the violations to the local community. Petitioners cited,
among other considerations, that Lake Michigan is a source of drinking
water for residents of the City of Chicago and surrounding region and
that the March 24, 2014 discharge of oil from the Facility into Lake
Michigan occurred only a few miles from the structures operating in
Lake Michigan to collect that drinking water. Petitioners further
argued that the violations were part of a broader environmental crisis
perpetuated by Respondent. The undersigned determined that while
Complainant did not provide a detailed explanation of how the civil
penalty assessed in the proposed CAFO had been calculated, and in
particular an account of how the environmental impact of the alleged
violations on the community, if any, was considered, it had considered
and responded to Petitioners' arguments in its Response to Comments and
Response to Petition. The undersigned further found that Petitioners
had produced no evidence to support their position or rebut
Complainant's position that it had properly implemented the applicable
policy governing its calculation and negotiation of the penalty
assessed in the proposed CAFO. The undersigned concluded that
Petitioners had not met the burden of demonstrating that the matters
they raised with respect to the assessment of a higher penalty
constituted material and relevant evidence that Complainant failed to
consider in agreeing to the proposed CAFO. Thus, Petitioners' claim in
this regard was denied.
---------------------------------------------------------------------------

    \3\ Petitioners described the arguments set forth in the
Petition as additions to the Comments they had previously submitted
to EPA in response to the public notice of EPA's intent to file the
proposed CAFO. Accordingly, the undersigned considered the arguments
raised by Petitioners in both the Petition and the Comments.
---------------------------------------------------------------------------

    Second, Petitioners urged that an additional fine of $100,000 be
levied against Respondent for its purported culture of indifference
towards health and safety, which, according to Petitioners, was evident
from the violations Respondent has committed and the ineffective
responses it has undertaken over many years. In considering this issue,
the undersigned first noted that EPA is limited to imposing the maximum
penalty permitted under applicable law for the violations alleged and
determining the penalty based on the statutory factors and that
Petitioners failed to cite any legal authority allowing EPA to impose a
fine beyond the maximum statutory penalty. The undersigned then noted
that Petitioners also failed to offer any argument or evidence
rebutting Complainant's position that it had properly implemented the
applicable policy governing its calculation and negotiation of the
penalty assessed in the proposed CAFO, which takes the statutory
penalty factors into account. Accordingly, the undersigned found that
with respect to this issue, Petitioners did not present any fact or
argument relevant and material to the proposed CAFO that was not
already considered by Complainant. Thus, the claim was denied.
    Third, Petitioners urged that a Supplemental Environmental Project
(SEP) be incorporated into the proposed CAFO for local projects and
that local residents be included in the projects. In association with
those requests, Petitioners questioned the manner in which funds for
SEPs were distributed by EPA and the Department of Justice and asserted
that residents had not been included in projects occurring in the Lake
George Branch of the Indiana Harbor Ship Canal. The undersigned found
that as Complainant had stated in its Response to Comments and Response
to Petition, EPA lacks the legal authority to demand a SEP or control
the distribution of civil penalty funds. The undersigned concluded that
given this lack of authority, the issues raised by Petitioners with
regard to a SEP were immaterial to the issuance of the proposed CAFO.
Thus, this claim was denied.
    Fourth, Petitioners urged that an independent advisory committee
and environmental monitoring program for Respondent's wastewater
treatment plant be created. Petitioners then questioned Respondent's
community outreach activities, which Complainant had referenced in its
Response to Comments. The undersigned found that as argued by
Complainant in its Response to Petition, EPA lacks the legal authority
under section 311(b)(6) of the CWA to establish advisory committees or
environmental monitoring programs or compel Respondent to engage in
outreach activities. The undersigned concluded that given the absence
of any material and relevant issue not considered by Complainant with
respect to the course of action requested by Petitioners, their claim
in this regard was also denied.
    Having found that Petitioners failed to present any relevant and
material evidence that had not been adequately considered and responded
to by Complainant in agreeing to the proposed CAFO, the undersigned
then addressed Petitioners' requests for a public hearing in their
Comments and Petition. Noting that Petitioners appeared to seek a
public forum, at least in part, for the parties to explain the meaning
of the proposed CAFO to the public, the undersigned observed that
section 311(b)(6)(B)(ii) of the CWA and the Rules of Practice provide,
not for a meeting of that nature, but rather a hearing at which
evidence is presented for the purpose of determining whether
Complainant met its burden of proving that Respondent committed the
violations as alleged and that the proposed penalty is appropriate
based on applicable law and policy. The undersigned noted that
Petitioners did not specifically identify any testimonial or
documentary evidence that they would present at any such hearing. The
undersigned further noted that Petitioners did not offer in either
their Comments or the Petition any relevant and material evidence or
arguments that had not already been adequately addressed by
Complainant. For these reasons, the undersigned found that resolution
of the proceeding by the parties would be appropriate without a
hearing.
    The undersigned thus issued the Order Denying Petition to Set Aside
Consent Agreement and Proposed Final Order.

    Dated: May 8, 2018.
Susan L. Biro,
Chief Administrative Law Judge.
[FR Doc. 2018-10568 Filed 5-16-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 15, 2010 (Volume 75, Number 178)]
[Rules and Regulations]
[Page 55973]
[DOCID:fr15se10-11]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 155

[USCG-1998-3417]
RIN 1625-AA19

Salvage and Marine Firefighting Requirements; Vessel Response
Plans for Oil

AGENCY: Coast Guard, DHS.

ACTION: Rule; information collection approval; clarification.

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SUMMARY: On September 3, 2010, the Coast Guard announced the Office of
Management and Budget (OMB) approval of the information collection
associated with the vessel response plan salvage and marine
firefighting requirements for tank vessels carrying oil. That
announcement indicated that the collection of information requirements
would be enforced beginning September 3, 2010. This document clarifies
that although OMB has approved the information collection, the
compliance date for updates to vessel response plans required by the
Salvage and Marine Firefighting final rule remains February 22, 2011.

DATES: The collection of information approved under OMB Control Number
1625-0066 became enforceable beginning September 3, 2010. The
compliance date for updates to vessel response plans required by the
Salvage and Marine Firefighting final rule remains February 22, 2011.

FOR FURTHER INFORMATION CONTACT: If you have questions on this document
contact Lieutenant Commander Ryan Allain at<PHONE_NUMBER> or
<EMAIL_ADDRESS>If you have questions on viewing the docket
(USCG-1998-3417), call Ms. Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On December 31, 2008, the Coast Guard
published a final rule entitled ``Salvage and Marine Firefighting
Requirements; Vessel Response Plans for Oil'' (73 FR 80618). The final
rule amended the vessel response plan salvage and marine firefighting
requirements for tank vessels carrying oil. The final rule included
information collection requirements affecting OMB Control Number 1625-
0066 that could not be enforced without approval by OMB. In the final
rule the Coast Guard stated that it would publish notice in the Federal
Register announcing OMB's decision to approve, modify, or disapprove
the collection.
    On August 31, 2009, the Coast Guard published another final rule
concerning vessel response plans, ``Vessel and Facility Response Plans
for Oil: 2003 Removal Equipment Requirements and Alternative Technology
Revisions'' (74 FR 45004). One of the effects of this rule was to defer
the compliance date for the salvage and marine firefighting
requirements from June 1, 2010, to February 22, 2011.
    The information collection associated with OMB Control Number 1625-
0066 affects a variety of vessel response plans, not just salvage and
marine firefighting requirements. On August 20, 2010, OMB approved the
Coast Guard's requested revisions to OMB Control Number 1625-0066, and
on September 3, 2010, the Coast Guard published a notice announcing
this approval (75 FR 54026). OMB approval of this information
collection does not alter the existing compliance date for vessel
response plan salvage and marine firefighting requirements for tank
vessels carrying oil.

    Dated: September 9, 2010.
Kathryn Sinniger,
Acting Chief, Office of Regulations and Administrative Law.
[FR Doc. 2010-22932 Filed 9-14-10; 8:45 am]
BILLING CODE 9110-04-P