[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4616-4620]
[FR Doc No: 2022-01724]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0008]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting that any consumer organizations interested in participating
in the selection of voting and/or nonvoting consumer representatives to
serve on its advisory committees or panels notify FDA in writing. FDA
is also requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. FDA seeks to include the views of women and men, members
of all racial and ethnic groups, and individuals with and without
disabilities on its advisory committees and, therefore, encourages
nominations of appropriately qualified candidates from these groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by March
14, 2022, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by March 14, 2022. Nominations will be accepted for current
vacancies and for those that will or may occur through December 31,
2022.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to [email protected] or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002.
    Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of an FDA advisory committee can also be obtained by visiting FDA's
website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>, [email protected].
    For questions relating to specific advisory committees or panels,
contact the appropriate Contact Person listed in table 1.

                  Table 1--Advisory Committee Contacts
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              Contact person                       Committee/panel
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Rakesh Raghuwanshi, Office of the Chief     FDA Science Board Advisory
 Scientist, Food and Drug Administration,    Committee.
 10903 New Hampshire Ave., Bldg. 1, Rm.
 3309, Silver Spring, MD 20993-0002, 301-
 796-4769, [email protected].
Shivana Srivastava, Office of Pediatric     Pediatrics Advisory
 Therapeutics, Office of the Commissioner,   Committee.
 Food and Drug Administration, 10903 New
 Hampshire Ave., Bldg. 32, Rm. 5157,
 Silver Spring, MD 20993-0002, 301-796-
 8695, [email protected].
Prabhakara Atreya, Center for Biologics     Allergenics Products
 Evaluation and Research, Food and Drug      Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 1226, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
LaToya Bonner, Center for Drugs Evaluation  Endocrinologic and Metabolic
 and Research, Food and Drug                 Drugs Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2428, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Moon Hee Choi, Center for Drugs Evaluation  Non-Prescription Drugs
 and Research, Food and Drug                 Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2434, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Joyce Frimpong, Center for Drugs            Psychopharmacologic Drugs
 Evaluation and Research, Food and Drug      Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2462, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Candace Nalls, Center for Devices and       Anesthesiology and
 Radiological Health, Food and Drug          Respiratory Therapy Devices
 Administration, 10903 New Hampshire Ave.,   Panel, Clinical Chemistry
 Bldg. 66, Rm. 5211, Silver Spring, MD       and Clinical Toxicology
 20993-0002,<PHONE_NUMBER>,                   Devices Panel,
 [email protected].                  Gastroenterology and
                                             Urology Devices Panel,
                                             General and Plastic Surgery
                                             Devices Panel.
Akinola Awojope, Center for Devices and     Dental Products Devices
 Radiological Health, Food and Drug          Panel, Obstetrics and
 Administration, 10903 New Hampshire Ave.,   Gynecology Devices Panel,
 Bldg. 66, Rm. 5216, Silver Spring, MD       Orthopaedic and
 20993-0002,<PHONE_NUMBER>,                   Rehabilitation Devices
 [email protected].                Panel.

James Swink, Center for Devices and         Circulatory System Devices
 Radiological Health, Food and Drug          Panel, Immunology Devices
 Administration, 10903 New Hampshire Ave.,   Panel, Microbiology Devices
 Bldg. 66, Rm. 5211, Silver Spring, MD       Panel, Ophthalmic Devices
 20993-0002,<PHONE_NUMBER>,                   Panel.
 [email protected].
Jarrod Collier, Center for Devices and      General Hospital and
 Radiological Health, Food and Drug          Personal Use Devices Panel,
 Administration, 10903 New Hampshire Ave.,   Hematology and Pathology
 Bldg. 71, Rm. 1333, Silver Spring, MD       Devices Panel, Molecular
 20993-0002,<PHONE_NUMBER>,                   and Clinical Genetics
 [email protected].                 Devices Panel, National
                                             Mammography Quality
                                             Assurance Advisory
                                             Committee, Radiology
                                             Devices Panel.
Letise Williams, Center for Devices and     Patient Engagement Advisory
 Radiological Health, Food and Drug          Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 5407, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
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  Committee/panel/areas of expertise needed          Type of  vacancy              Approximate date needed
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FDA Science Board Advisory Committee--The     1--Voting....................  Immediately.
 Science Board provides advice to the
 Commissioner of Food and Drugs
 (Commissioner) and other appropriate
 officials on specific complex scientific
 and technical issues important to FDA and
 its mission, including emerging issues
 within the scientific community.
 Additionally, the Science Board provides
 advice that supports the Agency in keeping
 pace with technical and scientific
 developments, including in regulatory
 science; and input into the Agency's
 research agenda, and on upgrading its
 scientific and research facilities and
 training opportunities. It also provides,
 where requested, expert review of Agency-
 sponsored intramural and extramural
 scientific research programs.
Pediatrics Advisory Committee--Knowledgeable  1--Voting....................  June 1, 2022.
 in pediatric research, pediatric
 subspecialties, statistics, and/or
 biomedical ethics. The core of voting
 members shall also include one
 representative from a pediatric health
 organization and one representative from a
 relevant patient or patient-family
 organization and may include one
 technically qualified member, selected by
 the Commissioner or designee, who is
 identified with consumer interests and is
 recommended by either a consortium of
 consumer-oriented organizations or other
 interested persons.
Allergenics Products Advisory Committee--     1--Voting....................  Immediately.
 Knowledgeable in the fields of allergy,
 immunology, pediatrics, internal medicine,
 biochemistry, and related specialties.
Endocrinologic and Metabolic Drugs Advisory   1--Voting....................  July 1, 2022.
 Committee--Knowledgeable in the fields of
 endocrinology, metabolism, epidemiology or
 statistics, and related specialties.
Non-Prescription Drugs Advisory Committee--   1--Voting....................  June 1, 2022.
 Knowledgeable in the fields of internal
 medicine, family practice, clinical
 toxicology, clinical pharmacology,
 pharmacy, dentistry, and related
 specialties.
Psychopharmacologic Drugs Advisory            1--Voting....................  July 1, 2022.
 Committee--Knowledgeable in the fields of
 psychopharmacology, psychiatry,
 epidemiology or statistics, and related
 specialties.
Anesthesiology and Respiratory Therapy        1--Nonvoting.................  Immediately.
 Devices Panel--Anesthesiologists, pulmonary
 medicine specialists, or other experts who
 have specialized interests in ventilator
 support, pharmacology, physiology, or the
 effects and complications of anesthesia.
Clinical Chemistry and Clinical Toxicology    1--Nonvoting.................  Immediately.
 Devices Panel--Doctor of Medicine or
 Philosophy with experience in clinical
 chemistry (e.g., cardiac markers), clinical
 toxicology, clinical pathology, clinical
 laboratory medicine, and endocrinology.
Gastroenterology and Urology Devices Panel--  1--Nonvoting.................  Immediately.
 Gastroenterologists, urologists, and
 nephrologists.
General and Plastic Surgery Devices Panel--   1--Nonvoting.................  Immediately.
 Surgeons (general, plastic, reconstructive,
 pediatric, thoracic, abdominal, pelvic, and
 endoscopic); dermatologists; experts in
 biomaterials, lasers, wound healing, and
 quality of life; and biostatisticians.
Dental Products Devices Panel--Dentists,      1--Nonvoting.................  Immediately.
 engineers, and scientists who have
 expertise in the areas of dental implants,
 dental materials, periodontology, tissue
 engineering, and dental anatomy.
Obstetrics and Gynecology Devices Panel--     1--Nonvoting.................  Immediately.
 Experts in perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology,
 operative hysteroscopy, pelviscopy,
 electrosurgery, laser surgery, assisted
 reproductive technologies, contraception,
 postoperative adhesions, and cervical
 cancer and colposcopy; biostatisticians and
 engineers with experience in obstetrics/
 gynecology devices; urogynecologists;
 experts in breast care; experts in
 gynecology in the older patient; experts in
 diagnostic (optical) spectroscopy; experts
 in midwifery; labor and delivery nursing.
Orthopaedic and Rehabilitation Devices        1--Nonvoting.................  Immediately.
 Panel--Orthopedic surgeons (joint spine,
 trauma, and pediatric); rheumatologists;
 engineers (biomedical, biomaterials, and
 biomechanical); experts in rehabilitation
 medicine, sports medicine, and connective
 tissue engineering; and biostatisticians.
Circulatory Systems Devices Panel--           1--Nonvoting.................  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure.

Immunology Devices Panel--Persons with        1--Nonvoting.................  Immediately.
 experience in medical, surgical, or
 clinical oncology, internal medicine,
 clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine.
Microbiology Devices Panel--Clinicians with   1--Nonvoting.................  Immediately.
 an expertise in infectious disease, e.g.,
 pulmonary disease specialists, sexually
 transmitted disease specialists, pediatric
 infectious disease specialists, experts in
 tropical medicine and emerging infectious
 diseases, mycologists; clinical
 microbiologists and virologists; clinical
 virology and microbiology laboratory
 directors, with expertise in clinical
 diagnosis and in vitro diagnostic assays,
 e.g., hepatologists; molecular biologists.
Ophthalmic Devices Panel--Ophthalmists with   1--Nonvoting.................  Immediately.
 expertise in corneal-external disease,
 vitreo-retinal surgery, glaucoma, ocular
 immunology, ocular pathology; optometrists;
 vision scientists; and ophthalmic
 professionals with expertise in clinical
 trial design, quality of life assessment,
 electrophysiology, low vision
 rehabilitation, and biostatistics.
General Hospital and Personal Use Devices     1--Nonvoting.................  Immediately.
 Panel--Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical
 engineers, or microbiologists/infection
 control practitioners or experts.
Hematology and Pathology Devices Panel--      1--Nonvoting.................  Immediately.
 Hematologists (benign and/or malignant
 hematology), hematopathologists (general
 and special hematology, coagulation and
 hemostasis, and hematological oncology),
 gynecologists with special interests in
 gynecological oncology, cytopathologists,
 and molecular pathologists with special
 interests in development of predictive
 biomarkers.
Molecular and Clinical Genetics Devices       1--Nonvoting.................  Immediately.
 Panel--Experts in human genetics and in the
 clinical management of patients with
 genetic disorders, e.g., pediatricians,
 obstetricians, neonatologists. The Agency
 is also interested in considering
 candidates with training in inborn errors
 of metabolism, biochemical and/or molecular
 genetics, population genetics,
 epidemiology, and related statistical
 training. Additionally, individuals with
 experience in genetic counseling, medical
 ethics, as well as ancillary fields of
 study will be considered.
Radiological Devices Panel--Physicians with   1--Nonvoting.................  Immediately.
 experience in general radiology,
 mammography, ultrasound, magnetic
 resonance, computed tomography, other
 radiological subspecialties, and radiation
 oncology; scientists with experience in
 diagnostic devices, radiation physics,
 statistical analysis, digital imaging, and
 image analysis.
National Mammography Quality Assurance        4--Voting....................  Immediately.
 Advisory Committee--Physician,
 practitioner, or other health professional
 whose clinical practice, research
 specialization, or professional expertise
 includes a significant focus on
 mammography.
Patient Engagement Advisory Committee--       1--Voting....................  Immediately.
 Experts who are knowledgeable in areas such
 as clinical research, primary care patient
 experience, and healthcare needs of patient
 groups in the United States. Selected
 Committee members may also be experienced
 in the work of patient and health
 professional organizations; methodologies
 for eliciting patient preferences; and
 strategies for communicating benefits,
 risks, and clinical outcomes to patients
 and research subjects.
----------------------------------------------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

    The Science Board Advisory Committee (Science Board) provides
advice to the Commissioner of Food and Drugs (Commissioner) and other
appropriate officials on specific complex scientific and technical
issues important to FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice that supports the Agency in keeping pace with technical
and scientific developments, including in regulatory science, and input
into the Agency's research agenda and on upgrading its scientific and
research facilities and training opportunities. It also provides, where
requested, expert review of Agency-sponsored intramural and extramural
scientific research programs.

B. Pediatrics Advisory Committee

    The Committee advises and makes recommendations to the Commissioner
regarding (1) pediatric research; (2) identification of research
priorities related to pediatric therapeutics and the need for
additional treatments of specific pediatric diseases or conditions; (3)
the ethics, design, and analysis of clinical trials related to
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric
labeling changes; (6) adverse event reports for drugs granted pediatric
exclusivity and any safety issues that may occur; (7) any other
pediatric issue or pediatric labeling dispute involving FDA regulated
products; (8) research involving children as subjects; and (9) any
other matter involving pediatrics for which FDA has regulatory
responsibility. The Committee also advises and makes recommendations to
the Secretary of Health and Human Services (HHS) directly or to the
Secretary of HHS through the Commissioner on research involving
children as subjects that is conducted or supported by the Department
of Health and Human Services.

C. Allergenics Advisory Committee

    Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease as well as the affirmation or revocation of biological
product licenses, on the safety, effectiveness, and labeling of the
products, on clinical and laboratory studies of such products, on
amendments or revisions to regulations governing the manufacture,
testing, and licensing of allergenic biological products, and on the
quality and relevance of FDA's research programs.

D. Endocrinologic and Metabolic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness

of marketed and investigational human drug products for use in the
treatment of endocrine and metabolic disorders.

E. Nonprescription Drugs Advisory Committee

    Review and evaluate available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug
products, or any other FDA-regulated product, for use in the treatment
of a broad spectrum of human symptoms and diseases and advise the
Commissioner either on the promulgation of monographs establishing
conditions under which these drugs are generally recognized as safe and
effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee will serve as a forum for
the exchange of views regarding the prescription and nonprescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency-sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.

F. Psychopharmacologic Drugs Advisory Committee

    The Psychopharmacologic Drugs Advisory Committee reviews and
evaluates data concerning the safety and effectiveness of marketed and
investigational human products for use in the practice of psychiatry
and related fields.

G. Certain Panels of the Medical Devices Advisory Committee

    The Medical Devices Advisory Committee has established certain
panels to review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area: (1)
Advises on the classification or reclassification of devices into one
of three regulatory categories and advises on any possible risks to
health associated with the use of devices; (2) advises on formulation
of product development protocols; (3) reviews premarket approval
applications for medical devices; (4) reviews guidelines and guidance
documents; (5) recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
(6) advises on the necessity to ban a device; and (7) responds to
requests from the Agency to review and make recommendations on specific
issues or problems concerning the safety and effectiveness of devices.
With the exception of the Medical Devices Dispute Resolution Panel,
each panel, according to its specialty area, may also make appropriate
recommendations to the Commissioner on issues relating to the design of
clinical studies regarding the safety and effectiveness of marketed and
investigational devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

H. National Mammography Quality Assurance Advisory Committee

    The National Mammography Quality Assurance Advisory Committee
advises the Agency on the following: Development of appropriate quality
standards and regulations for mammography facilities; standards and
regulations for bodies accrediting mammography facilities under this
program; regulations with respect to sanctions; procedures for
monitoring compliance with standards; establishing a mechanism to
investigate consumer complaints; and reporting new developments
concerning breast imaging that should be considered in the oversight of
mammography facilities. The Committee also advises the Agency on
determining whether there exists a shortage of mammography facilities
in rural and health professional shortage areas and determining the
effects of personnel on access to the services of such facilities in
such areas; determining whether there exist a sufficient number of
medical physicists; and determining the costs and benefits of
compliance with these requirements.

I. Patient Engagement Advisory Committee

    The Patient Engagement Advisory Committee advises the Agency on
complex issues relating to medical devices, the regulation of devices,
and their use by patients. The Committee may consider topics such as
Agency guidance and policies, clinical trial or registry design,
patient preference study design, benefit-risk determinations, device
labeling, unmet clinical needs, available alternatives, patient
reported outcomes and device-related quality of life or health status
issues, and other patient-related topics. The Committee will provide
relevant skills and perspectives to improve communication of benefits,
risks, and clinical outcomes and increase integration of patient
perspectives into the regulatory process for medical devices. The
Committee will perform its duties by discussing and providing advice
and recommendation in ways such as identifying new approaches,
promoting innovation, recognizing unforeseen risks or barriers, and
identifying unintended consequences that could result from FDA policy.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting

or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee and a signed copy of the
Acknowledgement and Consent form available at the FDA Advisory
Nomination Portal (see ADDRESSES), and a list of consumer or community-
based organizations for which the candidate can demonstrate active
participation.
    Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms of up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01724 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Page 11514]
[FR Doc No: 2018-05287]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0057; FRL-9974-56]

Pesticide Program Dialogue Committee; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, the
Environmental Protection Agency's (EPA's) Office of Pesticide Programs
is announcing a public meeting of the Pesticide Program Dialogue
Committee (PPDC) on May 2-3, 2018. This meeting provides advice and
recommendations to the EPA Administrator on issues associated with
pesticide regulatory development and reform initiatives, evolving
public policy and program implementation issues, and science issues
associated with evaluating and reducing risks from use of pesticides.

DATES: The meeting will be held on Wednesday, May 2, 2018, from 9 a.m.
to 5 p.m., and Thursday, May 3, 2018, from 9 a.m. to noon.
    Agenda: A draft agenda will be posted on or before April 18, 2018.
    Accommodations requests: To request accommodation of a disability,
please contact the person listed under FOR FURTHER INFORMATON CONTACT,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

ADDRESSES: The PPDC Meeting will be held at 1 Potomac Yard South, 2777
S Crystal Drive, Arlington, VA, in the lobby-level Conference Center.
    EPA's Potomac Yard South Bldg. is approximately 1 mile from the
Crystal City Metro Station.

FOR FURTHER INFORMATION CONTACT: Dea Zimmerman, Office of Pesticide
Programs (L-17J), Environmental Protection Agency, 77 W Jackson
Boulevard, Chicago, IL 60604; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you work in an
agricultural settings or if you are concerned about implementation of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the
Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to
both of these major pesticide laws by the Food Quality Protection Act
(FQPA) of 1996; the Pesticide Registration Improvement Act, and the
Endangered Species Act. Potentially affected entities may include, but
are not limited to: Agricultural workers and farmers; pesticide
industry and trade associations; environmental, consumer, and farm
worker groups; pesticide users and growers; animal rights groups; pest
consultants; State, local, and tribal governments; academia; public
health organizations; and the public. If you have questions regarding
the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2018-0057, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

    The PPDC is a federal advisory committee chartered under the
Federal Advisory Committee Act (FACA), Public Law 92-463. EPA
established the PPDC in September 1995 to provide advice and
recommendations to the EPA Administrator on issues associated with
pesticide regulatory development and reform initiatives, evolving
public policy and program implementation issues, and science issues
associated with evaluating and reducing risks from use of pesticides.
The following sectors are represented on the current PPDC:
Environmental/public interest and animal rights groups; farm worker
organizations; pesticide industry and trade associations; pesticide
user, grower, and commodity groups; Federal and State/local/tribal
governments; the general public; academia; and public health
organizations.

III. How can I request to participate in this meeting?

    PPDC meetings are free, open to the public, and no advance
registration is required. Public comments may be made during the public
comment session of each meeting or in writing to the person listed
under FOR FURTHER INFORMATION CONTACT.

    Authority:  7 U.S.C. 136 et. seq.

    Dated: February 22, 2018.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.
[FR Doc. 2018-05287 Filed 3-14-18; 8:45 am]
 BILLING CODE 6560-50-P


to subsurface soils, it does not remove the contaminants from the
environment. MNA, therefore, would not perform well with respect to the
requirement in 40 CFR 257.97(b)(4). This is particularly true in this
circumstance, where Alabama Power has failed to collect the site data
needed to identify whether any naturally occurring attenuation may be
occurring on-site, as well as the mechanism by which it occurs, and to
assess whether site characteristics that control and sustain this
naturally occurring attenuation are sufficient to immobilize the entire
release. Because the revised ACM presents no information that MNA would
meet these requirements, the ACM should have assessed MNA's performance
and reliability as ``low.''
    Similarly, in order for MNA through immobilization to be assessed
favorably with respect to its reliability at meeting the other
requirements in Sec.  257.97(b), such as the requirement in Sec.
257.97(b)(2) to attain groundwater protection standards, the chemical
reactions and processes involved that achieve immobilization must be
demonstrated to be present on site and be permanent. Immobilization
that is not permanent could be reversed, causing contaminants to be
released back into groundwater and to migrate off-site. Yet despite the
absence of any data demonstrating immobilization mechanisms to be
present, let alone permanent, the revised ACM assessed the reliability
of MNA through immobilization as ``high.'' This conclusion is
unsupported; since no immobilization mechanisms were

demonstrated to be present, they could not be known to be reliable.
    The revised ACM also fails to consider safety impacts, cross-media
impacts, and control of exposure to any residual contamination in its
assessment of MNA. See 40 CFR 257.96(c)(3). Neither the narrative nor
Table 5 in the 2020 ACM discuss these impacts for MNA. Yet Table 5 in
the 2020 ACM, in the column labeled ``potential impacts of remedy''
nevertheless concludes that the potential impacts from MNA are
``none.'' This conclusion is unsupported by data or analysis. This
conclusion is also inconsistent with other information in the revised
ACM. The Ash Pond and Bottom Ash Landfill are both adjacent to a river.
In the revised ACM in Figure 3, groundwater flow is depicted from the
Ash Pond toward the river. The Bottom Ash Landfill is also near and
upgradient from an adjacent river. As noted, the only MNA that is known
to occur at the site is dilution and dispersion (i.e., the normal
transport associated with groundwater releases.) This means that
contaminants are migrating in groundwater from the Ash Pond to the
river. Migration of contamination from groundwater to surface water is
a cross-media impact. Therefore, the assessment of potential impacts
from the remedy for MNA in Table 5, which includes these cross-media
impacts, should be ``high.''
    Conclusions without a supporting assessment or data do not
constitute ``an analysis of the effectiveness of potential control
measures.'' 40 CFR 257.96(c) (emphasis added). In addition, the lack of
data to support the assessments in the revised ACM means it may not
accurately reflect MNA's ``effectiveness in meeting all of the
requirements and objectives'' in Sec.  257.97(b). Inaccurate
assessments in an ACM can ultimately result in selection of a remedy
that will not meet the requirements of Sec.  257.97(b), which is what
appears to be occurring here.
    In an ACM, technologies' expected performances are compared with
one another according to how well each alternative meets each
regulatory criterion. The Revised ACM identified MNA as one of several
potential corrective measures to address groundwater contamination
(i.e., hydraulic control and treatment; in-situ treatment). Given both
the absence of any evidence of any attenuation mechanisms occurring at
the Ash Pond, and the conclusion in the revised ACM that the other
alternatives, such as pump and treat, are feasible, there would appear
to be no basis for assessing MNA more favorably than an alternative
that unquestionably removes contaminants from the environment. For the
same reasons, there is no apparent basis for ultimately selecting MNA
as the remedy.
    ADEM's Final Permit contains no measures to remedy this, even
though in their 2019 comments on the original ACM, ADEM raised many of
the same issues discussed above. For example, ADEM requested that
Alabama Power update the ACMs to include detailed information for each
requirement. In particular, the comments noted that:

    Furthermore, ADEM Admin. Code r. 335-13-15-.06(8)(b)3. and (b)4.
require that the remedy must (1)'' control the source(s) of releases
so as to reduce or eliminate, to the maximum extent feasible,
further releases of constituents in Appendix IV into the
environment'' and (2) '' remove from the environment as much of the
contaminated material that was released from the CCR unit as
feasible . . .''.The ACMs evaluate a number of options, with source
control (by consolidating and capping the CCR units) and monitored
natural attenuation (MNA) proposed as the most effective remedy. The
Department requests a more detailed justification for the proposed
remedies given that source control will not be achieved for an
average of 10 years and that no other mechanism is proposed to
reduce the potential for further releases to the'' maximum extent
feasible'.

    EPA was unable to find any evidence that a revised ACM or a more
detailed justification was submitted in response to ADEM's concerns. By
failing to require Alabama Power to take any concrete action to address
these deficiencies, the Final Permit effectively authorizes the
permittee to continue to indefinitely pursue a remedy that ADEM
previously determined had not been demonstrated to meet the
requirements in Sec.  257.97(b). Accordingly, EPA is proposing to
determine that the permit does not require Alabama Power to achieve
compliance with the Federal requirements; and because it allows the
facility to continue to delay implementing a remedy that would meet the
requirements of Sec.  257.97, the alternate State requirement is less
protective.
4. Plant Greene County
    EPA reviewed the Final Determination Initial Permit and Variance
for the Alabama Power Company, Greene County Electric Generating Plant
(Plant Greene County Permit), issued by ADEM under Permit No. 32-03 on
December 18, 2020.\106\ The permit summary on Page 1 says,
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    \106\ Alabama Department of Environmental Management. Final
Determination Initial Permit and Variance for the Alabama Power
Company, Greene County Electric Generating Plant, issued under
Permit No. 32-03. December 18, 2020.

[t]he Plant Greene County Ash Pond is a CCR surface impoundment
located in Sections 21 and 28, Township 19 North, Range 3 East in
Greene County, Alabama consisting of approximately 559.41 acres with
a disposal area that consists of approximately 477.24 acres. The
permit requires the Permittee to manage CCR in accordance with the
conditions of the permit, ADEM Admin. Code r. 335-13-15, ''
Standards for the Disposal of Coal Combustion Residuals in Landfills
and Surface Impoundments,'' and the approved permit application.
. . .
The Permittee must comply with all conditions of the permit except
to the extent and for the duration such noncompliance is authorized
by a variance granted by ADEM. The first variance requests to
exclude boron as an Appendix IV assessment monitoring constituent.
The second variance requests groundwater protection standards of 6
micrograms per liter ([micro]g/L) for cobalt; 15 [micro]g/L for
lead; 40 [micro]g/L for lithium; and 100 [micro]g/L for molybdenum.
The third variance requests the final grade of the cover system be
less than 5 percent and greater than 25 percent. The fourth variance
being requested is from 335-13-15-.03(6) requiring a 100 foot buffer
from the perimeter of the facility boundary.

    As with the other permits evaluated in this proposal, EPA has
identified issues with ADEM's approval of the closure, groundwater
monitoring network, and corrective action at Plant Greene County, which
are discussed below. As previously discussed, EPA focused on only a
subset of the potential issues associated with the permit and limited
its review to information in the permit record (e.g., the Permit
Application) and information publicly available on Alabama Power's CCR
website. This is because the purpose of this review is to determine
whether Alabama's program meets the statutory standard for approval,
not to reach final conclusions about an individual facility's
compliance with the CCR regulations.
a. Plant Greene County Closure Issues
    Plant Greene County had not completed closure of the Ash Pond when
ADEM issued the Final Permit in December 2020. But the final permit
ADEM issued looks largely the same as the permits issued to the other
facilities. ADEM incorporated the Alabama CCR regulations by reference
into the Final Permit for Plant Greene County, and it approved and
incorporated the Closure Plan submitted as part of the application into
the Final Permit without modification.\107\ The Final Permit provides:
---------------------------------------------------------------------------

    \107\ Although the Permit terms are ambiguous, it appears from
the Response to Public Comment that ADEM approved the Closure Plan
submitted as part of the Permit Application.

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

SECTION VII. CLOSURE AND POST-CLOSURE REQUIREMENTS.
A. Closure Timeframe and Notifications. The Permittee shall close
their CCR units as specified in 335-13-15-07(2), this permit and the
Application.
B. Criteria for Closure.
1. Cover. Closure of a CCR landfill, surface impoundment, or any
lateral expansion of a CCR unit must be completed by either leaving
the CCR in place and installing a final cover system or through
removal of the CCR and decontamination of the CCR unit, as described
in 335-13-15-.07(3)(b) through (j). The minimum and maximum final
grade of the final cover system may be less than 5 percent and
greater than 25 percent, as specified in the Permit Application.
(See Section IX.C.)
2. Written Closure Plan. The written closure plan, as part of the
Application, must include, at a minimum, the information specified
in 335-13-15-.07(3)(b)1.(i) through (vi).
3. Initiation of Closure Activities. Except as provided for in 335-
13-15-.07(3)(e)4 and 335-13-15-.07(4), the owner or operator of a
CCR unit must commence closure of the CCR unit no later than the
applicable timeframes specified in either 335-13-15-.07(3)(e)l or 2.
4. Completion of closure activities. Except as provided for in 335-
13-15-.07(3)(f)2, the owner or operator must complete closure of the
CCR unit subject to the requirements in 335-13-15-.07(3)(f)l.(i)
through (ii).

    According to the Closure Plan submitted with the Permit
Application, Alabama Power intends to remove CCR from the southern
portion of the Ash Pond and consolidate it within the northern portion
of the existing ash pond.\108\ After the excavation and consolidation
have been completed, the footprint of the remaining waste will occupy
approximately 221 acres. The Plan calls for the 221 acres of
consolidated waste to be closed in place, with a final cover system
consisting of an engineered synthetic turf and geomembrane to be
installed on the consolidated unit. In addition, according to the Plan,
a barrier wall keyed into the low permeability Demopolis Chalk will be
installed around the perimeter of the consolidated CCR material to
create a hydraulic barrier that ``limits the movement of interstitial
water through the constructed interior dike and existing northern
dike.'' \109\ This hydraulic barrier will be connected to the
geomembrane of the final cover system.\110\ According to the Closure
Plan:
---------------------------------------------------------------------------

    \108\ Alabama Power Company. Revised Closure Permit Application
for the Plant Greene County Ash Pond. April 30, 2020. Appendix 9, p
3, 18-19.
    \109\ Id. p.16.
    \110\ Additional details regarding the barrier wall system are
provided in the Permit Application in Appendix 6 and Appendix 7,
entitled ``Draft--Construction Quality Assurance Plan.'' Although
the drawings are marked with statements such as ``60 Percent Design
Package'' or ``Issued for 60% Client Review,'' and the Construction
Quality Assurance Plan is marked ``Draft,'' it appears that ADEM
approved these materials with the permit condition directing the
Permittee to close their CCR units ``as specified in the
Application.''

These actions will effectively control the source of CCR
constituents to groundwater by removing free water and some
interstitial water from the ash, reducing the footprint area of the
ash and preventing further infiltration of surface water resulting
from rainfall through the ash. Removal of the free liquid will
reduce the volume of water available to flow from the Ash Pond
during and after closure, while also minimizing the hydraulic head
driving water through the subsurface.\111\
---------------------------------------------------------------------------

    \111\ Alabama Power Company. Revised Closure Permit Application
for the Plant Greene County Ash Pond. April 30, 2020. Appendix 9, p
19.

    In many respects, the outlines of the closure presented in the Plan
could be implemented to be consistent with the Federal requirements;
however, ADEM approved the Plan without requiring Alabama Power to
provide the information necessary to confirm that several critical
closure requirements--which were not addressed or were insufficiently
described--would be met. Specifically, neither the Closure Plan nor
other materials in the Permit Application addressed how the performance
standards in Sec.  257.102(d)(2) will be met with respect to the
saturated CCR that it appears will remain in the base of the
consolidated unit. The Permit could either have specified what the
facility needs to do to meet the requirements, or ADEM could have
required the facility to submit a revised Closure Plan. ADEM did
neither, and as a consequence, there is no binding and enforceable
provision for the facility to comply with these performance standards.
In essence, ADEM has issued a permit that allows the facility to decide
whether to comply with Sec.  257.102(b) and (d)(2), rather than
``requiring each CCR unit to achieve compliance with'' those
provisions. 42 U.S.C. 6945(d)(1).
    While it was in operation, the base of the Ash Pond was in
continuous contact with the groundwater beneath the unit. Even now
groundwater continues to saturate the CCR in the unit.\112\ EPA
estimated the amount of saturated CCR remaining in the Ash Pond using
the same methodologies described above for Plants Colbert and Gadsden.
The average groundwater elevation from groundwater monitoring wells in
the vicinity of the Ash Pond between September 2019 and August 2021 is
84.8 ft above MSL. While the base elevation for the unit varies, by
relying on an average base elevation of 83 feet, EPA estimates that, on
average, just under 2 feet in depth of CCR across the entire footprint
of the impoundment is currently in contact with groundwater. This
equates to roughly 640,000 CY of saturated waste. Dewatering and pool
drawdown continue at the site, and when combined with the installation
of the slurry wall, groundwater elevations would be expected to
decrease over time. However, the extent to which the CCR will remain
saturated once closure activities are completed cannot be estimated due
to the lack of information in the relevant documents.
---------------------------------------------------------------------------

    \112\ Alabama Power Company. Revised Closure Permit Application
for the Plant Greene County Ash Pond. April 30, 2020. GWMP pp 220-
221.
---------------------------------------------------------------------------

    As discussed previously, the Federal regulations applicable to
surface impoundments closing with waste in place require that ``[f]ree
liquids must be eliminated by removing liquid wastes or solidifying the
remaining waste and waste residues, [and that] remaining wastes must be
stabilized sufficient to support final cover system.'' 40 CFR
257.102(d)(2). But due to the deficiencies in the Closure Plan, it is
not clear that the closure approved by ADEM will meet either standard.
    According to the approved Closure Plan, various dewatering
techniques will be employed before and during closure; however, the
Closure Plan appears to limit the use of these techniques to the CCR in
the southern portion of the unit that will be excavated and transported
to the consolidated area, and to the areas under the new dike.\113\ For
example, in the sections specifically discussing dewatering, the
Closure Plan states:
---------------------------------------------------------------------------

    \113\ Alabama Power Company. Revised Closure Permit Application
for the Plant Greene County Ash Pond. April 30, 2020. Appendix 9, pp
5,7, and 9.

i. Dewatering
Dewatering of the CCR Ponds consists of two phases: decanting of
free water and dewatering of interstitial water within the CCR
material. Dewatering will be required prior to ash excavation and
throughout construction. . . .
Interstitial dewatering refers to the removal of subsurface water
within the saturated CCR material. This dewatering requires lowering
phreatic water levels to improve material handling for excavation
and transport. Removal of interstitial water will likely require
both passive and active methods of drainage.
* * * * *
The CCR material within the subgrade of the proposed interior dike
will be over excavated and a stable, temporary slope formed to the
interior to allow the dike and barrier wall to be constructed.
During this time, the subgrade beneath the new dike will be
dewatered (discussed in a following section).
* * * * *

As dewatering continues, CCR material will be excavated from the
closure by removal areas and placed and compacted in horizontal
lifts on top of the existing CCR material within the consolidation
area.
As discussed previously, the CCR material will be dewatered in a
systematic fashion prior to and during excavation activities, to
maintain the phreatic surface below the working elevation of removal
operations. For construction of the closed ash pond, it is expected
that the CCR material will be handled multiple times prior to final
placement and closure of the pond. CCR material will be stacked and
dewatered to the proper moisture content prior to placement in the
consolidation area.

(emphasis added).\114\ The Closure Plan lacks the required description
of how--or even whether--Alabama Power intends to dewater the entire
unit. For example, there are inconsistent statements in the Closure
Plan about the scope of the dewatering activities Alabama Power intends
to conduct. In one section, there is a reference to ``dewatering of
wetter ash across the site, especially in the southern end of the
pond.'' But the remainder of the discussion focuses on a technique that
is unlikely to be used on CCR that is not intended to be excavated and
transferred, which suggests that Alabama Power does not intend to fully
dewater all of the CCR in the unit. Specifically, the Closure Plan
states that:
---------------------------------------------------------------------------

    \114\ Alabama Power Company. Revised Closure Permit Application
for the Plant Greene County Ash Pond. April 30, 2020. Appendix 9, pp
7-8.

Utilization of stacking & casting methods is anticipated. With this
approach, ash with higher moister[sic] content will be excavated and
stacked in piles to allow for gravity drainage. A similar technique
of windrowing may be used throughout the site. This technique
involves spreading the wet ash in thin lifts and rowing/tilling the
ash to allow the moisture to evaporate from the surface.
To expedite interstitial water dewatering and construction
stormwater management, a capillary break drainage system may also be
considered for the ash excavation/placement around the interior
dike. The drainage system will help relieve pore water pressure in
the underlying ash as the weight of earthwork filling is applied.

This is compounded by the Closure Plan's repeated references to the
removal of ``free water,'' rather than the ``free liquids'' the Federal
regulations specify must be eliminated.\115\ For example, on pages 18-
19, under the heading ``f. Achievement of Closure Performance
Standards,'' the Closure Plan states:
---------------------------------------------------------------------------

    \115\ Alabama Power Company. Revised Closure Permit Application
for the Plant Greene County Ash Pond. April 30, 2020. Appendix 9, pp
5, 7-8, 19.

Free water will be removed, and interstitial water will be lowered
to accomplish the CCR removal from the closure by removal areas and
to close in a consolidated footprint.
* * * * *
These actions will effectively control the source of CCR
constituents to groundwater by removing free water and some
interstitial water from the ash, reducing the footprint area of the
ash and preventing further infiltration of surface water resulting
from rainfall through the ash.

(emphasis added). Alabama Power has defined the term ``free water'' in
other Closure Plans as ``water contained in the CCR unit above the
surface of CCR material.'' \116\ Compare, 40 CFR 257.53 (definition of
``free liquids'').
---------------------------------------------------------------------------

    \116\ See, e.g., Alabama Power Company. Revised Closure Plan for
the Plant Gorgas Ash Pond. Appendix 11, p 7.
---------------------------------------------------------------------------

    Moreover, the Closure Plan never refers to the groundwater within
the northern portion of the unit or describes any engineering measures
that will be implemented to remove these liquids. Based on the
information provided, further engineering measures would be necessary
to effectively eliminate these free liquids from the unit prior to
installing the final cover system, required by Sec.  257.102(d)(2)(i).
Absent further data demonstrating that saturated CCR will not be
present in the base of the closed unit prior to the installation of the
final cover system, the permit record does not support a finding that
the remaining wastes will be stabilized sufficiently to support the
final cover system, as required by Sec.  257.102(d)(2)(ii). If the CCR
in the unit is not sufficiently stabilized, e.g., if it has not been
completely drained prior to the installation of the final cover system,
differential settlement of the CCR after installation of the cover
system is possible, especially given the substantial added load from
the consolidation of CCR from the southern portion of the Ash Pond. If
the settlement is great enough it could cause a disruption in the
continuity, and potentially failure, of the final cover system.
Additional information is needed to determine that the permit meets
Federal requirements. This could have been accomplished either by
requiring submission of the information prior to the issuance of the
permit or by including a permit term requiring submission of the
information, along with a clause allowing for further permit conditions
if necessary.
    Based on all of the above, EPA is proposing to determine that, by
failing to resolve these issues, ADEM's permit does not require the
Plant Greene County Ash Pond to achieve compliance with the Federal
requirements for closure, or with alternative closure requirements that
are at least as protective as the Federal requirements.
b. Plant Greene County Groundwater Monitoring Issues
    Based on EPA's review of the approved groundwater monitoring well
network, EPA is proposing to determine that ADEM approved a groundwater
monitoring system that fails to meet the Federal requirements. As
previously discussed, the Federal regulations specify that a
groundwater monitoring system must be installed that ``consists of a
sufficient number of wells, installed at appropriate locations and
depths, to yield groundwater samples from the uppermost aquifer that
accurately represents the quality of the groundwater passing the waste
boundary of the CCR unit.'' 40 CFR 257.91(a)(2). The regulations
further specify that ``[a]ll potential contaminant pathways must be
monitored.'' Id. But as discussed in more detail below, EPA is
proposing to determine that ADEM approved a groundwater monitoring plan
with an insufficient number of wells laterally along the perimeter of
the unit to monitor all contaminant pathways. EPA is also proposing to
determine that monitoring wells in the approved plan were not installed
at appropriate depths to ensure that all contaminant pathways in the
entire uppermost aquifer were monitored. These are essentially the same
issues previously discussed with respect to Plants Gadsden and Gorgas.
i. Insufficient Number of Downgradient Compliance Wells Installed at
Appropriate Depths To Monitor the Entire Aquifer (Inadequate Vertical
Spacing)
    The downgradient well network approved by ADEM was focused
primarily on a narrow subset of the uppermost geologic layers within
what is referred to in the Permit Application as Unit 2: Poorly Graded
Sands With Gravel Lenses. Other interconnected portions of the
uppermost aquifer are not being monitored as discussed below. When
evaluating whether monitoring wells are installed at appropriate depths
(i.e., the adequacy of vertical monitoring well coverage), it is
important to look at cross-sectional views of the entire uppermost
aquifer in the vertical dimension to understand interrelationships of
groundwater monitoring wells, screen depths, and lithological
variations. These points are illustrated (in part) in the geologic
cross-sections on Figures 5A and 5B included on pages 208 and 209 of
the Permit Application, which show that the uppermost aquifer consists
of layers of

poorly graded sands with gravel lenses (identified as Unit 2), as well
layers of lean clay to sandy clay (identified as Unit 1). These cross
sections and the boring logs that were included in the Permit
Application confirm that the two geologic formations are hydraulically
interconnected and both are therefore the ``uppermost aquifer.'' See,
40 CFR 257.53 (defining uppermost aquifer to include lower
hydraulically connected aquifers). Accordingly, monitoring wells must
be installed in the two formations.
    Nearly all of the compliance wells at the waste boundary of the
unit are screened in Unit 2, well below (in some cases over 20 feet
below) the top of the uppermost aquifer; as a consequence there are an
insufficient number of wells across nearly all of Unit 1. More
precisely, EPA found that the groundwater monitoring well network for
the Ash Pond unit has an insufficient number of wells screened in Unit
1 (i.e., a vertical data gap) along at least three sides, as follows:
(1) a 1500-foot section of Unit 1 parallel to the Barge Canal, as shown
on Figure 4A, entitled ``Geologic Cross Section A-A' Plant Greene
County Ash Pond''; (2) a 6000-foot section of Unit 1 along the western
side of the unit, as shown on Figure 4B, entitled ``Geologic Cross
Section B-B' Plant Greene County Ash Pond''; and (3) an approximately
2000-foot section of Unit 1, along the northern side of the unit
between groundwater monitoring wells GC-AP-MW-59-HO and GC-AP-MW-1 as
shown on Figure 4C, entitled ``Geologic Cross Section C-C' Plant Greene
County Ash Pond.'' These figures are found in the 2021 Plant Greene
County Annual GWMCA Report.\117\ EPA was unable to determine if a
similar gap currently exists along the southern side of the Plant
Greene County Ash Pond, because no cross-section extending along the
southern waste boundary of the unit was included in either the 2021
Plant Greene County Annual GWMCA Report or the Permit Application. The
omission of a cross-section in the Permit Application that extends
along the southern side of the Ash Pond is significant because, given
the proximity to the Black Warrior River, which is located immediately
adjacent to the south and southeast of the Ash Pond, additional
potential contaminant pathways that would need to be monitored would
normally be expected to be present.
---------------------------------------------------------------------------

    \117\ Alabama Power. Plant Greene 2021 Annual Groundwater
Monitoring and Corrective Action Report. January 31, 2022. Two
similar geologic cross sections are found in the Groundwater
Monitoring Plan included in the Permit Application. The two geologic
cross sections were included as Figures 4A, for A-A1, and 4B, for B-
B1; however, no geologic cross section for C--C1 was included in the
Permit Application.
---------------------------------------------------------------------------

ii. Insufficient Lateral Spacing of Compliance Wells To Monitor All
Potential Contaminant Pathways
    EPA is also proposing to determine that ADEM approved lateral
spacing between wells along the perimeter of the Ash Pond that is
insufficient to meet the performance standards in Sec.  257.91(b).
Monitoring wells used for the detection and assessment monitoring
program are spaced approximately one thousand feet apart with few
exceptions. Large lateral well spacings are particularly problematic to
the east, south and west of the waste boundary of the unit where
groundwater is expected to discharge to surface water. Given the
proximity to the various surface water features, such as the Black
Warrior River and the Barge Canal, the large well spacings make it
likely that potential contaminant pathways from groundwater discharging
to surface water located immediately adjacent to the Ash Pond are not
being monitored. This groundwater to surface water pathway was
acknowledged in the Permit Application with a statement that reads, as
follows: ``Groundwater that migrates downward into the surficial
aquifer will migrate vertically through the Unit 1 clay and then,
primarily laterally (horizontal) and to a lesser extent vertically
along more coarse fractions of the Unit 2 aquifer toward the Black
Warrior River and barge canal.'' \118\
---------------------------------------------------------------------------

    \118\ Alabama Power Company. Revised Closure Permit Application
for the Plant Greene County Ash Pond. April 30, 2020. PDF pp. 192.
---------------------------------------------------------------------------

    Based on the concerns discussed above, EPA is proposing to
determine that by approving the deficient downgradient groundwater
monitoring well network in the Permit Application, ADEM's final permit
does not require Alabama Power to achieve compliance with the
performance standards in Sec.  257.91(a)(2), or with an equally
protective alternative.
c. Plant Greene County Corrective Action Issues
In November 2018, SSLs above the groundwater protection standards at
Plant Greene County were reported for arsenic and lithium. An ACM was
prepared in June 2019 (``2019 ACM''). On December 18, 2020, ADEM issued
a final permit to Alabama Power for the Plant Greene County Ash Pond.
In the RTC for the Final Permit, ADEM states:

In November of 2019, the Department provided extensive comments to
Alabama Power related to the submitted ACM and proposed final
remedy. The Department's comments addressed many of the concerns
raised by commenters, including the selection of monitored natural
attenuation (MNA) as the final remedy despite providing limited data
to its efficiency as a remedy. To date, Alabama Power has not
submitted a revised ACM, as the facility has been collecting
additional data to support a final remedy proposal.

    The Plant Greene County Final Permit only contained a recitation of
the corrective action regulations, but did not require Alabama Power to
achieve compliance with those requirements. This is because the Final
Permit does not require Alabama Power to take specific actions to
correct the deficiencies in the 2019 ACM, even though, as discussed in
its RTC on the permit, ADEM identified them a year before issuing the
Final Permit. Significantly, ADEM did not determine what actions are
still necessary in light of those facts for Alabama Power to achieve
compliance with the regulations and include those actions as
requirements in the Final Permit. For example, the Final Permit does
not require the permittee to take any particular actions to address
ADEM's comments on the 2019 ACM or with respect to Alabama Power's
proposed remedy, such as specifying the additional data needed to
support the permittee's preferred remedy under a set timetable. As a
consequence, EPA is proposing to determine that the permit authorized
Alabama Power to continue to indefinitely pursue a remedy that appears
not to meet the requirements of Sec.  257.97(b), and that is based on
the results of an ACM that does not meet the requirements of Sec.
257.96.
    Whether the 2019 ACM meets the requirements of the regulations, and
what actions Alabama Power must take to remediate groundwater in
compliance with Sec.  257.97 are precisely the types of issues that
must be determined before the permit is issued. This is because, once
the permit is issued, the requirements in the permit become the State
requirements with which the Permittee must comply. 42 U.S.C.
6945(d)(3)(A). And if the permittee is not in compliance with the
regulations, the permit must specify what the permittee is required to
do in order to achieve compliance with those regulations. This is the
role of a permitting authority (i.e., ADEM). Delaying this decision
until after permit issuance effectively allows Alabama Power to
continue operating out of compliance with the regulations, while
operating in compliance with the permit. This results in a permit
program

that is less protective than the Federal regulations.
    As discussed below, EPA is proposing to determine that the Final
Permit fails to require Alabama Power to achieve compliance with
several of the Federal corrective action requirements.
    These are many of the same deficiencies that ADEM identified in its
comments on the 2019 ACM, but declined to remedy in the permit issued a
year and a half later.\119\
---------------------------------------------------------------------------

    \119\ Alabama Department of Environmental Management. Response
to CCR Comments Submitted to the Department, Alabama Power Company.
November 14, 2019. pp 6-7.
---------------------------------------------------------------------------

i. The Final Permit Does Not Require Collection of the Data Needed To
Support Assessments in the ACM
    As discussed previously, Sec.  257.95(g)(1) requires a facility to
characterize the nature and extent of the release and any relevant site
conditions that may affect the remedy ultimately selected. The
characterization must be sufficient to support a complete and accurate
assessment of the corrective measures necessary to effectively clean up
all releases from the CCR unit pursuant to Sec.  257.96. The 2019 ACM
delineates releases of arsenic, cobalt, and lithium but does not
characterize site conditions that would affect any of the potential
remedies identified in the ACM (e.g., testing for the presence and
quantity of arsenic and lithium detected in soils to demonstrate they
are being removed from the groundwater and immobilized on-site.)
    The 2019 ACM identified MNA as a potential corrective measure to
address groundwater contamination, in addition to other corrective
measures (e.g., hydraulic control and treatment; in-situ treatment).
However, Alabama Power failed to collect the site data needed to
identify whether natural attenuation may be occurring on-site, as well
as the mechanism by which it occurs, and to assess whether site
characteristics that control and sustain this naturally occurring
attenuation are sufficient to immobilize the entire release. For
example, in order to accurately assess MNA, site data are needed to
determine whether immobilization occurs on-site through adsorption or
absorption to subsurface soils. In addition, data would be needed to
determine whether the chemical reactions and processes involved that
achieve immobilization are permanent. Immobilization that is not
permanent could be reversed, causing contaminants to be released back
into groundwater and to migrate off-site.
    Although the Remedy Selection Report contained some data regarding
the presence of released constituents in soils,\120\ the relative
performance, reliability, ease of implementation, and the time required
to begin and complete the remedy must also be assessed for each
alternative, including MNA. 40 CFR 257.96(c)(1) and (2). These
assessments must be supported with site characterization data and
analysis, but no data were provided in the ACM to support an assessment
of MNA against these criteria, relative to other alternatives, to
support its selection. The Remedy Selection Report discusses site data
in the context of these criteria for MNA only, with no side-by-side
assessments of alternatives based on site data provided. Additionally,
the data discussed in Section 4.3.2 of the Remedy Selection Report do
not demonstrate that any significant amount of lithium or cobalt is
being immobilized in the solids samples.\121\
---------------------------------------------------------------------------

    \120\ Alabama Power Company. Plant Greene County Groundwater
Remedy Selection Report, September 2021. Appendix D, Tables 6, 9 and
19.
    \121\ Id at Appendix D, Tables 6 and 12.
---------------------------------------------------------------------------

ii. The Final Permit Does Not Require Submission of a Revised ACM That
Accurately Assesses MNA According to the Criteria in 40 CFR 257.96(c)
    No naturally occurring attenuation mechanisms other than dilution
and dispersion were identified at Plant Greene County in the ACM.
Alabama Power acknowledges in the ACM that, ``USEPA (2015) discourages
using dilution and dispersion as primary MNA mechanisms, as these
mechanisms disperse contaminant mass rather than immobilize it.'' \122\
Regardless, Alabama Power assessed the performance of MNA as ``medium''
based on the fact that the aquifer is sandy and dilution and dispersion
(i.e., releases of contaminants) are occurring.
---------------------------------------------------------------------------

    \122\ Alabama Power Company. Assessment of Corrective Measures
Greene County Ash Pond. June 2019, p. 12
---------------------------------------------------------------------------

    This favorable assessment of MNA is inconsistent with Sec.
257.97(b)(4), which specifies that ``[r]emedies must . . . remove from
the environment as much of the contaminated material that was released
from the CCR unit as is feasible.'' Neither dilution nor dispersion
removes the contaminants from the environment. Therefore, at this site
MNA would not meet this requirement, since the constituents would
remain in the environment, albeit in a different environment (i.e., the
river rather than the aquifer). Absent information to support a
conclusion that MNA can meet these requirements at this site, MNA
performance and reliability should have been assessed as ``does not
meet.''
    Further, in order for MNA through immobilization to be assessed
favorably with respect to its reliability at meeting the other
requirements in Sec.  257.97(b), such as the requirement in Sec.
257.97(b)(2) to attain groundwater protection standards, the chemical
reactions and processes involved that achieve immobilization must be
demonstrated to be permanent. Immobilization that is not permanent
could be reversed, causing contaminants to be released back into
groundwater and to migrate off-site. Assessing the reliability of MNA
through immobilization as ``high'' in the ACM was not supported by
data, since no immobilization mechanisms were identified, they could
not be known to be reliable. Although Section 4.3.2 of the Remedy
Selection Report contained some data regarding the presence of released
constituents in soils, the data do not demonstrate that any significant
amount of lithium or cobalt are being immobilized in the solid
samples,\123\ and therefore these data do not actually support
selection of MNA as a primary remedy for these contaminants.\124\
---------------------------------------------------------------------------

    \123\ Alabama Power Company. Plant Greene County Groundwater
Remedy Selection Report, September 2021. Appendix D, Tables 6 and
12.
    \124\ Some data were provided in the Remedy Selection Report to
indicate arsenic may be immobilized on-site.
---------------------------------------------------------------------------

    In another section of the ACM, MNA was assessed as easy to
implement because no design or construction would be required. If MNA
occurs through immobilization of constituents in the subsurface that is
not permanent, this would generally require ongoing monitoring as long
as contaminants remain in the soil--indefinitely--in accordance with
Sec.  257.98(a)(1). Since the goal of the remedy would be for
immobilized constituents to remain in the subsurface indefinitely,
monitoring would be needed to demonstrate whether this goal is
achieved. This is a much longer compliance monitoring timeframe than
any other alternative, except possibly in-situ geochemical
manipulation, which means that implementation is not significantly
easier than alternatives that can be completed sooner, such as
hydraulic control and treatment.
    EPA is also proposing to determine that the ACM fails to meet the
requirements to consider safety impacts, cross-media impacts, and
control of exposure to any residual contamination in its assessment of
MNA in either the narrative or Table 6. See 40 CFR 257.96(c)(3). Table
6, in the column labeled ``potential impacts of remedy'' assesses the
potential impacts from MNA as ``none.'' This conclusion is

unsupported by data or analysis. This conclusion is also inconsistent
with information in the ACM. The Ash Pond is bounded on three sides by
adjacent surface water features. In the ACM in Figure 3, groundwater
flow is depicted from the Ash Pond toward surface water features.
Further, as noted Section 4.2.1 of the Groundwater Monitoring Plan,
entitled ``Groundwater Elevations and Flow,'' ``[g]roundwater
elevations in monitoring wells located adjacent or close to the barge
canal and the river appear to demonstrate a temporary reversal of flow
to the groundwater system associated with recent storm events.'' This
temporary reversal of flow indicates a connection between surface water
and groundwater in the vicinity of the Ash Pond.
    Because no site data were presented to demonstrate that
immobilization of lithium or cobalt is occurring at Plant Greene, the
only MNA that is known to occur for these two constituents is dilution
and dispersion (i.e., the normal transport associated with groundwater
releases). This means that these contaminants are migrating in
groundwater from the Ash Pond to the river. Migration of contamination
from groundwater to surface water is a cross-media impact. Therefore,
the assessment of potential impacts from the remedy for MNA in Table 6,
which includes these cross-media impacts, should be ``high.''
    Conclusions without a supporting assessment or data do not
constitute ``an analysis of the effectiveness of potential control
measures.'' 40 CFR 257.96(c) (emphasis added). In addition, the lack of
data means the ACM does not sufficiently establish MNA's
``effectiveness in meeting all of the requirements and objectives'' in
Sec.  257.97(b). Inaccurate assessments in an ACM can ultimately result
in selection of a remedy that will not meet the requirements of Sec.
257.97(b).
    ADEM identified many of these same issues in their comments on the
2019 ACM. For example, on page 6, ADEM states:

ADEM Admin. Code r. 335-13-15-.06(8) contains substantial
requirements that must be evaluated when selecting a remedy, such as
the long- and short-term effectiveness and protectiveness of the
potential remedy, the effectiveness of the remedy in controlling the
source to reduce further releases, among many others. The ACMs
submitted by APCO do not match the level of detail required in the
regulations. Please update the ACMs to include detailed information
for each requirement of this section. Furthermore, ADEM Admin. Code
r. 335-13-15-.06(8)(b)3. and (b)4. require that the remedy must (1)
``control the source(s) of releases so as to reduce or eliminate, to
the maximum extent feasible, further releases of constituents in
Appendix IV into the environment'' and (2) ``remove from the
environment as much of the contaminated material that was released
from the CCR unit as feasible. . .''.
* * * * *
The Department requests a more detailed evaluation of the
effectiveness of MNA, or any other proposed remedy, based on site
specific conditions.

Yet ADEM's Final Permit does not require Alabama Power to take any
actions to remedy any of the deficiencies they identified.
iii. The Permit Does Not Require an Assessment of Source Control
Measures
    The permit record contains no assessment of source control
measures. Section 2.5 of the 2019 ACM describes the approved closure
with waste remaining in the Ash Pond but contains no assessment of how
well the closure would control releases. Nor can that information be
found in the Remedy Selection Report, or the Closure Plan.
    Moreover, the ACM neither identifies nor assesses any alternative
measures. 40 CFR 257.96 requires that various alternatives for source
control be compared in accordance with the criteria in Sec.  257.96(c).
    ADEM raised similar concerns in their comments, which state:

The ACMs evaluate a number of options, with source control (by
consolidating and capping the CCR units) and monitored natural
attenuation (MNA) proposed as the most effective remedy. The
Department requests a more detailed justification for the proposed
remedies given that source control will not be achieved for an
average of 10 years and that no other mechanism is proposed to
reduce the potential for further releases to the ``maximum extent
feasible''.

Yet the permit ADEM subsequently issued does not require any actions to
remedy this deficiency.
5. EPA Conclusion About Alabama's Implementation of the CCR Regulations
    Given the systemic problems noted above in ADEM's CCR permits
related to the groundwater monitoring, corrective action and closure
requirements, EPA is proposing to determine that ADEM's implementation
of its permit program is resulting in a State program that is notably
less protective than the Federal CCR regulations. First, ADEM's permits
allow closure with waste in place in unlined surface impoundments,
without requiring any, or sufficient, controls to prevent groundwater
from flowing in and out of CCR in the units indefinitely. In such
circumstances, the permit will allow ongoing contamination of
groundwater from CCR impoundments. Second, ADEM's permits do not
require Permittees to achieve compliance with the groundwater
monitoring regulations. The State-issued permits discussed in this
notice approve groundwater monitoring networks that are insufficient to
accurately determine if a unit is leaking. Finally, ADEM's permits are
inadequate related to the implementation of the corrective action
requirements because they allow facilities to delay effective responses
to contaminant releases that may pose a risk to human health and the
environment. Compounding this problem is the fact that the groundwater
monitoring networks are insufficient and that means there may be
additional unmonitored releases are occurring.
    Ultimately, Alabama's CCR permit program Application would not
``require each coal combustion residuals unit located in the State to
achieve compliance with the applicable [Federal or other equally
protective State] criteria.'' 42 U.S.C. 6945(d)(1)(B). Therefore, EPA
is proposing this denial of Alabama's CCR permit program Application.

V. Proposed Action

    EPA has preliminarily determined that the Alabama CCR permit
program does not meet the statutory standard for approval. Therefore,
in accordance with 42 U.S.C. 6945(d), EPA is proposing to deny the
Alabama CCR permit program.

Michael S. Regan,
Administrator.
[FR Doc. 2023-17023 Filed 8-11-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Page 4000]
[FR Doc No: 2015-01275]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9707; 34-74106; File No. 265-28]

Investor Advisory Committee Meeting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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

SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting. The public is invited to submit
written statements to the Committee.

DATES: The meeting will be held on Thursday, February 12, 2015 from 10
a.m. until 4 p.m. (ET). Written statements should be received on or
before February 12, 2015.

ADDRESSES: The meeting will be held in Multi-Purpose Room LL-006 at the
Commission's headquarters, 100 F Street NE., Washington, DC 20549. The
meeting will be webcast on the Commission's Web site at www.sec.gov.
Written statements may be submitted by any of the following methods:

Electronic Statements

    [ssquf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements to Brent J. Fields, Secretary,
Securities and Exchange Commission, 100 F Street NE., Washington, DC
20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1580,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. All statements received will be posted without change;
we do not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Marc Sharma, Senior Special Counsel,
Office of the Investor Advocate, at<PHONE_NUMBER>, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public,
except during portions of the meeting reserved for meetings of the
Committee's subcommittees. Persons needing special accommodations to
take part because of a disability should notify the contact person
listed in FOR FURTHER INFORMATION CONTACT.
    The agenda for the meeting includes: Remarks from Commissioners; a
recommendation of the Market Structure subcommittee on shortening the
trade settlement cycle; a discussion of proxy access; an update on the
rule proposal of the Financial Industry Regulatory Authority
(``FINRA'') regarding implementation of the Comprehensive Automated
Risk Data System; an update on Municipal Securities Rulemaking Board
and FINRA proposals for improved disclosures for same-day, retail-size
principal transactions in fixed income securities; and nonpublic
subcommittee meetings.

    Dated: January 21, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-01275 Filed 1-23-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16336-16338]
[FR Doc No: 2019-07790]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0209]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 11 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. They are unable to meet the vision requirement in one eye for

various reasons. The exemptions enable these individuals to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

DATES: The exemptions were applicable on March 9, 2019. The exemptions
expire on March 9, 2021.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2018-0209, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On February 6, 2019, FMCSA published a notice announcing receipt of
applications from 11 individuals requesting an exemption from vision
requirement in 49 CFR 391.41(b)(10) and requested comments from the
public (84 FR 2323). The public comment period ended on March 8, 2019,
and three comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with the current regulation 49 CFR
391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received three comments in this proceeding. Daniel Schafer,
of Patriot Transportation Services, LLC, submitted a comment describing
the vision and CMV operation experience of an unnamed individual.
    Vicky Johnson, from the Minnesota Department of Public Safety (MN
DPS), submitted two comments. The comments stated that MN DPS had no
objections to FMCSA's decision to grant exemptions to Kirby L. Sundet
and Henry J. Hughes.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for up to five years from the vision standard in 49 CFR 391.41(b)(10)
if the exemption is likely to achieve an equivalent or greater level of
safety than would be achieved without the exemption. The exemption
allows applicants to operate CMVs in interstate commerce. FMCSA grants
exemptions from the FMCSRs for a two-year period to align with the
maximum duration of a driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision, as well as their
driving records and experience driving with the vision deficiency. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the February 6, 2019, Federal
Register notice (84 FR 2323) and will not be repeated in this notice.
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 11
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, chorioretinal scar, complete loss of
vision, exotropia, hamartoma, macular scar, prosthesis, and retinal
scar. In most cases, their eye conditions were not recently developed.
Six of the applicants were either born with their vision impairments or
have had them since childhood. The five individuals that sustained
their vision conditions as adults have had it for a range of 12 to 28
years. Although each applicant has one eye that does not meet the
vision requirement in 49 CFR 391.41(b)(10), each has at least 20/40
corrected vision in the other eye, and, in a doctor's opinion, has
sufficient vision to perform all the tasks necessary to operate a CMV.
    Doctors' opinions are supported by the applicants' possession of a
valid license to operate a CMV. By meeting State licensing
requirements, the applicants demonstrated their ability to operate a
CMV with their limited vision in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. We
believe that the applicants' intrastate driving experience and history
provide an adequate basis for predicting their ability to drive safely
in interstate commerce. Intrastate driving, like interstate operations,
involves substantial driving on highways on the interstate system and
on other roads built to interstate standards. Moreover, driving in
congested urban areas exposes the driver to more pedestrian and
vehicular traffic than exists on interstate highways. Faster reaction
to traffic and traffic signals is generally required because distances
between them are more compact. These conditions tax visual capacity and
driver response just as intensely as interstate driving conditions.
    The applicants in this notice have driven CMVs with their limited
vision in careers ranging for 5 to 41 years. In the past three years,
no drivers were involved in crashes, and no drivers were convicted of
moving violations in CMVs. All the applicants achieved a record of
safety while driving with their vision impairment that demonstrates the
likelihood that they have adapted their driving skills to accommodate
their condition. As the applicants' ample driving histories with their
vision deficiencies are good predictors of future performance, FMCSA
concludes their ability to drive safely can be projected into the
future.
    Consequently, FMCSA finds that in each case exempting these
applicants from the vision requirement in 49 CFR

391.41(b)(10) is likely to achieve a level of safety equal to that
existing without the exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must be physically examined every year (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10) and
(b) by a certified Medical Examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) each driver
must provide a copy of the ophthalmologist's or optometrist's report to
the Medical Examiner at the time of the annual medical examination; and
(3) each driver must provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file, or
keep a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the exemption when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 11 exemption applications, FMCSA
exempts the following drivers from the vision requirement, 49 CFR
391.41(b)(10), subject to the requirements cited above:

Manuel Gonzalez (IL)
Henry J. Hughes (MN)
Frederick L. McCurry (VA)
Luis M. Perez-Francisco (NJ)
Emmanuel A. Sepulveda (CA)
Martin Serrano (IL)
Kirby L. Sundet (MN)
Karl M. Vanderstucken (TX)
Nyrone Whyte (CT)
Bryon L. Wright (DE)
Bradford C. Zipse (WI)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136 and 31315.

    Issued on: April 11, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-07790 Filed 4-17-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61835-61836]
[FR Doc No: 2015-26166]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0002]

Notice of Adjustment of Minimum Project Worksheet Amount

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: FEMA gives notice that the minimum Project Worksheet Amount
under the Public Assistance program for disasters and emergencies
declared on or after October 1, 2015, will be increased.

DATES: Effective Date: October 1, 2015, and applies to major disasters
and emergencies declared on or after October 1, 2015.

FOR FURTHER INFORMATION CONTACT: William Roche, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act 42 U.S.C. 5121-5207 and 44 CFR 206.202(d)(2)
provide that FEMA will annually adjust the minimum Project Worksheet
amount under the Public Assistance program to reflect changes in the
Consumer Price Index for All Urban Consumers published by the
Department of Labor.
    FEMA gives notice of an increase to $3,050 for the minimum amount
that will be approved for any Project Worksheet under the Public
Assistance program for all major disasters and emergencies declared on
or after October 1, 2015.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 0.2 percent for the 12-month period
that ended in August 2015. This is based on information released by the
Bureau of Labor Statistics at the U.S. Department of Labor on September
16, 2015.

    Catalog of Federal Domestic Assistance No. 97.036, Disaster
Grants--Public Assistance (Presidentially Declared Disasters).

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-26166 Filed 10-13-15; 8:45 am]
BILLING CODE 9111-23-P