[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Page 21558]
[FR Doc No: 2016-08336]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1101]

EMD Serono; Withdrawal of Approval of a New Drug Application for
LUVERIS

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of a new drug application (NDA) for LUVERIS
(lutropin alpha for injection) held by EMD Serono, One Technology
Place, Rockland, MA 02370. EMD Serono has voluntarily requested that
approval of this application be withdrawn, thereby waiving its
opportunity for a hearing.

DATES: Effective April 12, 2016.

FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3381.

SUPPLEMENTARY INFORMATION: FDA approved LUVERIS (lutropin alpha for
injection) on October 8, 2004, under the Agency's accelerated approval
regulations, 21 CFR part 314, subpart H. LUVERIS is indicated for
concomitant administration with GONAL-F (follitropin alfa for
injection) for stimulation of follicular development in infertile
hypogonadotropic hypogonadal women with profound luteinizing hormone
deficiency. In a letter dated April 30, 2012, EMD Serono requested that
FDA withdraw approval of NDA 021322 for LUVERIS under Sec.  314.150(c).
In that letter, EMD Serono noted that, as had been previously discussed
with the Agency, it was not feasible to complete a trial that the
company had agreed to at the time of approval under subpart H. By
letter dated December 8, 2014, FDA notified EMD Serono that, when
studies that are required as a condition of approval under the Agency's
accelerated approval regulations are not completed, the approval of an
application is withdrawn according to the procedures set forth in
Sec. Sec.  314.530 and 314.150(d) rather than under Sec.  314.150(c).
FDA requested that EMD Serono submit a new withdrawal request under
Sec.  314.150(d).
    Following additional correspondence, by letter dated July 23, 2015,
EMD Serono requested that FDA withdraw approval of NDA 021322 for
LUVERIS under Sec.  314.150(d) because a postmarketing study that was
required as a condition of approval under subpart H was not completed.
Because that study was required to verify and describe the clinical
benefit of the drug product, the clinical benefit of LUVERIS has not
been confirmed, and it has not been established to be safe and
effective. In its July 23, 2015, letter, EMD Serono waived any
opportunity for a hearing otherwise provided under Sec. Sec.  314.150
and 314.530. FDA responded by letter dated September 2, 2015,
acknowledging EMD Serono's request that FDA withdraw approval of
LUVERIS under Sec.  314.150(d). FDA also acknowledged that EMD Serono
waived its opportunity for a hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), and
under authority delegated by the Commissioner to the Director, Center
for Drug Evaluation and Research, approval of NDA 021322, and all
amendments and supplements thereto, is withdrawn (see DATES).
Distribution of this product in interstate commerce without an approved
application is illegal and subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08336 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P


NATIONAL ADVISORY COUNCIL FOR ENVIRONMENTAL POLICY AND TECHNOLOGY ( NACEPT)

SUPERFUND SUBCOMMITTEE MEMBERS UPDATED JULY 15, 2003 CHAIR:

Raymond Loehr, Professor of Civil Engineering, University of Texas, Austin Texas.

Dr. Loehr's teaching and research interests emphasize hazardous and industrial waste management, and land as a waste management alternative. Current research activities relate to development and use of hazardous waste technologies for contaminated liquids, slurries, solids and soils. Specific research involves bioremediation, transport and fate of constituents when wastes are treated by hazardous and industrial waste management processes. A recipient of numerous awards and honors including the Simon W. Freese Environmental Engineering Award ( American Society of Civil Engineers), the Rachel Carson Award ( Society of Environmental Toxicology and Chemistry), Dr. Loehr is a recognized expert on municipal, industrial and hazardous waste management. He has published over 300 technical publications and reports and authored or edited 14 books. He has served on numerous boards and committees, including EPA's Science Advisory Board, National Research Council Committees, DOD's Science Advisory Board and served as the Vice President of the American Academy of Environmental Engineers.

MEMBERS:

Bill Adams, Director of Environmental Science, Kennecott Utah Copper Corporation, Magna, Utah.

Dr. Adams' educational background includes a B. S. in Biological Sciences, an M. S. in Wildlife Toxicology, and a Ph. D. in Aquatic Toxicology. His experience includes extensive work on ecotoxicology and human health risk assessment, including ecotoxicological risk assessments for metals. He has worked on individual Superfund sites and also has experience with other forms of site cleanup. He possesses a broad base of domestic and international contacts at all levels of government, academia, and industry, including considerable experience working with EPA's Science Advisory Board.

Sue Briggum, Director of Environmental Affairs, Waste Management, Inc. Washington, DC.

For the past 15 years, Ms. Briggum has been a key member of the Waste Management's department for overseeing remediation activities. She is responsible for issues arising in federal legislation, regulation and policy initiatives. She currently co chairs the National Environmental Policy Commission and chairs the Superfund Action Alliance ( a coalition of more than 50 companies and business trade associations). She is a member of the Superfund Settlements Project and is a current steering committee member of the Business Network for Environmental Justice. She is the coauthor of the Hazardous Waste Regulation Handbook: A Practical Guide to RCRA and Superfund.

Doris Cellarius, Co Chair, Sierra Club's Environmental Quality Strategy Doris Cellarius currently co chairs the Sierra Club's Environmental Quality Strategy Team, the entity that advises and supports committees that deals with pollution and environmental justice. She recently retired to Prescott, Arizona, from Washington state, where she worked with communities at Superfund and other toxic sites. She was active in the development and support of MTCA, Washington's toxic clean up law. For three years she served as a Community Consultant to ATSDR's Board of Scientific Counselors where she helped organize its Community/ Tribal Forum. Doris has a Masters degree in zoology from Columbia University.

Grant Cope, Attorney, Earthjustice, Seattle, WA.

Mr. Cope is responsible for analyzing, drafting and negotiating proposed legislation and agency rules and guidance pertaining to toxic waste cleanup, drinking water protections, right to know laws and agency rulemaking processes. For the past 10 years, his professional focus has been on environmental law and advocacy. He has clerked at several environmental organizations including the Oregon Natural Desert Association, the Pacific Environmental Advocacy Center, the National Wildlife Federation and the Oregon Natural Resources Council.

Jim Derouin, Attorney, Steptoe & Johnson, Phoenix, AZ.

For the past 30 years, Mr. Derouin has practiced environmental law. He has represented numerous national clients on a broad range of sophisticated environmental issues including environmental liability, groundwater and surface water quality, hazardous waste disposal, mining, endangered species and complex permitting matters. He has chaired the Environmental and Natural Resources Law Section of the State Bar of Arizona and the Phoenix Environmental Quality Commission. He is a member of a variety of councils and committees, and has made numerous presentations on environmental legal issues including " The Federal Experience   Settling under CERCLA," and " A Ticking Time Bomb: Land Use and Development Implications of Superfund Sites."

Richard Dewling, President, Dewling Associates, Inc. Union, NJ.

Mr. Dewling has been involved in the Superfund program since its inception; as Region II Deputy Regional Administrator and Regional Administrator ( 1976 1983); Commissioner of New Jersey Department of Environmental Protection ( 1983 1988); President of Metcalf & Eddy Engineering ( 1988 1993); and in his current capacity as President of Dewling Associates. As head of Dewling Associates, he oversees activities related to a range of engineering, technical and regulatory services for CERCLA, RCRA, NPDES and the Clean Air Act. He has published more than 100 scientific/ engineering articles dealing with wastewater treatment technology, ocean pollution, and solid and hazardous waste management and treatment. He is the recipient of various awards and has extensive professional affiliations/ activities.

Steve Elbert, Senior Vice President, Global Environmental Management, British Petroleum America, Inc. Warrenville, IL.

Mr. Elbert heads the unit in British Petroleum ( BP) responsible for managing BP's environmental liabilities worldwide. Prior to his current appointment, he was responsible for health, safety and environmental policies and performance throughout BP's operations. He has been intimately involved in both the theoretical and practical implementation of Superfund at one of the largest companies in the US. He holds three degrees in biological science: a Ph. D., a Masters and a Bachelors.

Jane Gardner, Manager and Counsel, Corporate Environmental Programs, General Electric Co., Fairfield, CT.

Ms. Gardner has practiced in the field of environmental law with a special emphasis on remediation for nearly 20 years. She directly manages approximately 350 of GE's remediation projects, including 75 active NPL sites. She also coordinates RCRA corrective action work within the Company. She interacts with both Federal and State regulators on both site specific and national and regional policy issues. She also works directly with community groups, local governments, and advocacy groups. She has a strong working knowledge of risk assessment and risk management procedures both at the federal and state level. Prior to GE, Ms. Gardner was an attorney in EPA's Region 8.

Glenn Hammer, Vice President of Environmental Health and Safety, Ashland, Inc., Columbus, Ohio.

Mr. Hammer, as Vice President for Environmental, Health and Safety for Ashland, Inc., directs the company's regulatory performance, as well as the company's cleanup of contaminated sites. He has significant experience working with EPA, states and environmental groups on Superfund and other environmental issues through his participation in the Regulatory Roundtable of the American Chemistry Council, the Air and Waste Management Association, the Water Environment Federation, and the IEF Steering Committee of the World Environment Center.

Delores Herrera, Executive Director, Albuquerque San Joes Community Awareness Council, Inc., Albuquerque, NM.

Ms. Herrera administers a project in her minority/ people of color, low income neighborhood that encompasses environmental and socio economic justice. She is affiliated with numerous boards and committees nationally and locally, and has extensive experience working in Superfund related arenas. She created the first grassroots community driven bilingual health survey in a Superfund community in New Mexico. She manages a Superfund Technical Assistance Grant for the South Valley and AT& SF Superfund sites in Albuquerque. She conceptualized, organized and co produced a " Three Day Summit on Superfund Environmental Justice" that has become a model used around the country. She served as a representative to the EPA's National Environmental Justice Advisory Council. She also served on DOE's Citizen Advisory Council to Sandia National Labs.

Robert Hickmott, Senior Vice President, The Smith Free Group, Washington, DC.

Mr. Hickmott has diverse and extensive experience in government, politics and the business community. He served as Counselor to HUD Secretary Andrew Cuomo and directed HUD's Brownfields program. Prior to that, he was the AA for Congressional Affairs at EPA where he helped to develop and implement the Clinton's Administration's environmental agenda on Superfund, Clean Water Act, Brownfields and other issues. In the private sector, he has worked on Brownfields/ Superfund projects including the OII site in Monterrey Park, CA. He also consulted with the City of Chatanooga on its efforts to integrate Brownfields, Superfund and low income housing programs to revitalize a depressed part of the city. He also serves as a consultant on Brownfields/ Superfund issues with the Kennecott Corp. and the Mortgage Bankers Association.

Aimee Houghton, Associate Director, Center for Public Environmental Oversight, Washington, DC.

Ms. Houghton has been the associate director of the Center for Public Environmental Oversight since 1996. She coordinates all programmatic work and meets regularly with DOD, EPA and service branch staff on military and environmental issues. She has worked extensively across the country with community groups, who are actively engaged in environmental remediation at federal facility Superfund sites. She has served on the Federal Facilities Environmental Restoration Dialogue Committee, the National Dialogue on Military Munitions, and participated in the Range Rule Risk Methodology validation. Ms. Houghton has written several articles on military environmental cleanups, and she coauthored the 1995 " Military Contamination and cleanup Atlas for the United States." She speaks nationally and internationally on military and environmental issues.

Ken Jock, Director, Environmental Division, St. Regis Mohawk Tribe, Akwesasne, NY.

Mr. Jock, a biologist by training, heads the St. Regis Mohawk Tribe's Environment Division. The Division implements an environmental protection program which is responsible for air and water quality monitoring, soil analysis, developing and enforcing tribal standards, sanitation and waste disposal, environmental rehabilitation/ reclamation, and emergency preparedness and response. Largely due to the fact that the St. Regis Mohawk Reservation is situated next to a Superfund site, the Tribe has one of the most advanced environment divisions of any Tribe in the country. In recognition of the Tribe's environmental program development, Mr. Jock received an EPA Region II Environmental Quality Award in 1993. Frederick Kalisz, Jr. Mayor, City of New Bedford, MA Mayor Kalisz, elected to office in 1998, has a deep understanding of environmental issues ranging from toxic contamination to watershed ecology. Prior to his mayoral election, Mr. Kalisz was the program coordinator of the Buzzard's Bay Project Toxic Use Reduction Program in which he was the liaison between business and government regulatory and non regulatory technical assistance agencies. His tenure as mayor has reflected a strong emphasis on environmental issues which has resulted in the City of New Bedford being designated as one of 12 Brownfields Showcase Communities. He has been the recipient of various awards, including a Meritorious Public Service Award by the USCG and US DOT, and an Outstanding Achievement Award for Public/ Private Partnerships by the US Conference of Mayor's.

Gary King, Manager, Division of Remediation Management, Bureau of Land, Illinois Environmental Protection Agency, Springfield, IL Since 1990, Gary King has held the position of senior manager for the Illinois EPA site cleanup programs. His accomplishments include: Established and manages implementation of the Illinois EPA Brownfield assistance program  a program that is an excellent model for the cleanup and reuse of contaminated land; Illinois EPA team leader for numerous legislative and regulatory initiatives, including the IEPA risk based cleanup objectives program  TACO, or Tiered Approach to Corrective Action Objectives; Established and manages implementation of the Illinois EPA voluntary cleanup program. ( This program is regarded as one of the most effective one of its kind in the nation); Managed the overhauling of the LUST program  increasing its productivity and reducing cleanup costs by over 50%. Gary King is the chair of the ASTSWMO CERCLA Research Center. In that role he has frequent contact with other States and EPA concerning important issues to State and federal Superfund programs. Finally, Gary King is a frequent speaker on topics related to the Illinois EPA cleanup programs within Illinois and across the United States. Prior to 1990 Mr. King managed Illinois EPA land enforcement programs. He is an attorney and holds a B. S degree in civil engineering.

Ed Lorenz, Chair, Pine River Superfund Citizens Task Force/ Professor of History and Political Science, Alma College, Alma, MI.

Dr. Lorenz chairs the Pine River Superfund Citizen Task Force a group which concerns itself with three Superfund sites in the St. Louis, MI, area. The Taskforce group provides a model forum for communicating with public officials community health and environmental concerns and informing residents about risks and remediation alternatives. Since EPA initiated the emergency cleanup of the Pine River site in 1998, the Taskforce, under Dr. Lorenz's leadership, has advised EPA on community concerns and begun to promote brownfield redevelopment of the site. The group is guided by a theory that assumes citizen involvement in technical decision making is essential in a democracy. Dr. Lorenz's academic pursuits also mirror his dedication to environmental policy: his 1998 course on Public Health and Environmental Policy on the Texas Mexican Border was named one of the best science and service courses by National Campus Compact. As a professor at Alma College, Dr. Lorenz has received several teaching awards.

Mildred McClain, Executive Director, Harambee House, Inc., Savannah, GA.

Dr. McClain has an extensive history working with environmental justice issues. Since 1991, she has served as Executive Director of Citizens for Environmental Justice, Inc. In that position, she has served as the organization's administrator, field organizer, policy analyst, trainer, fund raiser, and program development coordinator. She has established and coordinated a variety of Superfund related community involvement/ environmental justice activities including the establishment of the Academic Community Agency Network with the Superfund Working Group and the People of Color and Disenfranchised Communities Environmental Health Network ( a national communitybased network addressing Federal facilities issues). She currently serves on several key environmental justice related committees: the National Environmental Policy Commission, the Savannah River Site Health Effects Subcommittee, the African American Environmental Justice Action Network, and the National Black Environmental Network. Dr. McClain holds an Ed. D. from the Harvard Graduate School of Education.

Michael Mittelholzer, Director, Regulatory Affairs, National Association of Home Builders, Washington, DC.

Mr. Mittelholzer serves as the NAHB's Director of Air, Waste and Wildlife. In this capacity he oversees NAHB regulatory efforts concerning several environmental statues including the Clean Air Act, CERCLA, RCRA, TSCA and the Endangered Species Act. Mr. Mittelholzer focuses mainly on environmental statutes concerning waste, air, and transportation issues affecting land development operations. He serves on a Congressionally chartered FACA that examines land use and transportation impacts on air quality. Prior to joining NAHB, he worked for the State of Maryland's Department of Environment where he coordinated environmental permits for manufacturing facilities expanding or locating within the state. He has a BA in Political Science and a MS in Environmental Science.

Thomas Newlon, Senior Counsel, Port of Seattle, Seattle, WA.

Mr. Newlon has been an attorney for the Port of Seattle since 1992, and has led the Port's negotiations with EPA on numerous innovative settlements over the past 10 years. He has been the principal point of contact for EPA management regarding the Port on all environmental matters over the past nine years. The Port of Seattle is a special purpose local government with responsibilities for Seattle's seaport operations and the Seattle Tacoma International Airport. The Port collaborated with EPA on a groundbreaking prospective purchaser agreement that took a highly contaminated operating facility from initial NPL listing through upland remediation to an operating container terminal facility and public access area in less than four years. The project saved EPA roughly $ 21 million in cleanup activities, and was dedicated by Vice President Al Gore. Prior to coming to the Port, Mr. Newlon was an environmental law professor and aquatic biologist specializing in invertebrate communities. He has published numerous articles on ecological related issues.

Lindene Patton, Vice President, Zurick U. S. Specialities, Zurick North America, Great Falls, VA.

As the Vice President and Director, Risk Management & Executive Counsel at Zurich, Ms. Patton has been actively involved in the development of creative insurance and financial assurance products which facilitate cost effective, expedited, remediations. A certified industrial hygienist and a member of the American Board of Industrial Hygiene, Ms. Patton holds a MPH in biomedical and environmental health science and a Juris Doctorate. She frequently speaks about environmental insurance and has authored several publications on the topic. In addition to her membership in the American Board of Industrial Hygiene, Ms. Patton is a member of the Environmental Technology Verification Advisory Board, a member of the American Bar Association and a past member of the Occupational Safety and Health Coalition Advisory Board.

Victoria Peters, Assistant Attorney General, Colorado Attorney General Office, Lakewood, CO.

Ms. Peters brings a unique perspective to consideration of the proposed topics of the Subcommittee because she has a firm grasp of broad policy issues as well as hands on experience litigating complex CERCLA cases and participating in the CERCLA process at various sites. Ms. Peters acts as a policy advisory to the CO Department of Public Health and the Environment, the Governor's Office and the Colorado Attorney General on legislative and regulatory issues that implicate CERCLA. Her caseload is dominated by CERCLA litigation and cases that focus on mining waste issues and natural resource damage questions. She has published numerous articles on CERCLA related issues including " Can States Enforce RCRA at Superfund Sites?"

Kate Probst, Senior Follow, Resources for the Future, Washington, DC.

Ms. Probst is the author and director of a major study estimating the costs of the Superfund program from 2000 2010, a project requested by the Senate Appropriations Committee as a part of the FY 2000 EPA appropriations conference report. She has also coauthored numerous other Superfund and hazardous waste related articles and books ( Footing the Bill for Superfund: Who Pays and How?, Long Term Stewardship and the Nuclear Weapons Complex: The Challenge Ahead, and The Evolution of Hazardous Waste Programs: Lessons from Eight Countries) and speaks frequently on the Superfund program. She holds a Master's degree in City and Regional Planning from Harvard University. Ed Putnam, Assistant Director, Remedial Planning and Design, New Jersey Department of Environmental Protection, Trenton, NJ.

Mr. Putnam has extensive experience in the Superfund program having served both the State and the US EPA while performing hazardous site remediation work during his 21 year career. He has a Bachelor's degree in Environmental Engineering and is currently serving as the Assistant Director for the Remedial Planning and Design Element in the State of NJ's Division of Publicly funded Site Rededication. He represents NJ on the Association of State and Territorial Solid Waste Management Officials ( ASTSWMO). He participated in the Resources for the Future Superfund's Future: What Will It Cost?

Catherine Sharp, Assistant Division Director, Land Protection Division, Oklahoma Department of Environmental Quality, Oklahoma City, OK.

Ms. Sharp has been Assistant Director of the Land Protection Division within the OK DEQ for ten years. In that capacity, she manages several state and federal waste programs, including hazardous waste compliance and enforcement, RCRA Corrective Action, Superfund, UIC and solid waste. She is a member of the Association of State and Territorial Solid Waste Management Officials ( ASTSWMO).

Alexandria Shultz, Director of Legislative Affairs, Mineral Policy Center, Washington, DC.

As Director of Legislative and Regulatory Affairs at the Mineral Policy Center, Ms. Shultz focuses on reforming mining laws and regulations to promote environmentally and fiscally responsible mining. In that effort, she monitors legislation and regulations, educates decision makers and assists local communities engaged in mining related disputes. Prior to her tenure at the Mineral Policy Center, Ms. Shultz was a staff attorney at the US Public Interest Research Group where she worked on a variety of environmental issues. A member of the Connecticut Bar, Ms. Shultz has a JD and Environmental Law Certificate from Pace University School of Law.

Mel Skaggs, President, InDepth Environmental Associates, Inc., Southlake TX.

Mr. Skaggs has more than 20 years of experience at all levels of responsibility in the environmental, health, and safety industry. He has served as the principal manager of these programs for a Fortune 500 U. S. based international energy corporation where he directed the development and implementation of environmental management systems in such sensitive environs as tropical forest, arid deserts, and off shore oil platforms. He has extensive experience in applying Superfund and analogous state remedial response programs at complex sites. He has directed over $ 350 million in remedial response activities at sites spread among five EPA regions. Remedial programs directed by Mr. Skaggs have resulted in the generation of two patented innovative treatment technologies, as well as over 50 publications in peer reviewed professional journals. He is a member of the Society of Petroleum Engineers, the American Institute of Chemical Engineers, the Air and Waste Management Association, the Water Environment Federation and the Western Hemisphere Dredging Association.

Rich Stewart, Emily Kempin Professor of Law, Center of Environmental and Land Use Law, New York University School of Law, New York, NY.

Mr. Stewart's current research focuses on economic instruments for environmental protection, environmental liabilities for injury to natural resources, the relation of environmental protection to market economics, comparative law and federalism issues in environmental protection. He also serves as counsel at Sidley, Austin Brown and Wood in New York where his practice focuses on environmental liabilities including natural resource damages; environmental regulation; and emissions trading. He has extensive professional activities and memberships including serving: as an Advisory Trustee and member to the Litigation Review Committee, Environmental Defense, a member of the American Law Institute, and a member of the Editorial Board of both the Oxford Journal of Environmental Law and Review of European Community and International Environmental Law. From 1989 1991, Mr. Stewart served as the Assistant Attorney General for Environment and Natural Resources Division at DOJ.

Wilma Subra, Technical Advisor, Louisiana Environmental Action Network, New Iberia, LA.

Currently serves as NACEPT co chair.

Michael Tilchin, Vice President, CH2M Hill, Herndon, VA.

Mr. Tilchin serves as the National Client Services Manager for the US EPA contracts. In this capacity he has corporate responsibility on Response Action Contracts in several EPA Regions. Specific responsibilities on Superfund contracts include quality assurance, contract compliance, technical and project delivery innovation, client relationships, small business subcontracting, conflict of interest management, and financial performance. He authored " Superfund Reauthorization   Pathway to the Endgame," and served as a peer reviewer for the Resources for the Future study, Superfund's Future   What Will It cost?

Jason White, Environmental Scientist, Cherokee Nation, Tahlequah, OK.

Mr. White works primarily with issues pertaining to Superfund. His responsibilities cover a range of Superfund related activities including natural resource damage assessments, technical work for remedial investigations/ feasibility studies, site discovery, sampling and environmental reviews and assessments. He is a registered Environmental Specialist and Sanitarian. He is a member of the Oklahoma Society of Environmental Health Professionals, American Society of Safety Engineers, and the Safety and Environmental Management Association. Robin Weiner, President, Institute for Scrap Recycling Industries, Inc., Washington, DC.

Mr. White works primarily with issues pertaining to Superfund. His responsibilities cover a range of Superfund related activities including natural resource damage assessments, technical work for remedial investigations/ feasibility studies, site discovery, sampling and environmental reviews and assessments. He is a registered Environmental Specialist and Sanitarian. He is a member of the Oklahoma Society of Environmental Health Professionals, American Society of Safety Engineers, and the Safety and Environmental Management Association.


[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63115]
[FR Doc No: 2022-22554]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96038; File No. SR-CboeBZX-2022-045]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Amend the Opening Auction Process Provided Under Rule
11.23(b)(2)(B)

October 12, 2022.
    On August 15, 2022, Cboe BZX Exchange, Inc. (``BZX'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend the
Opening Auction process provided under Rule 11.23(b)(2)(B). The
proposed rule change was published for comment in the Federal Register
on August 31, 2022.\3\ The Commission has received no comments on the
proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 95601 (Aug. 25,
2022), 87 FR 53514.
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days (i) as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or (ii) as to which the self-
regulatory organization consents, the Commission shall either approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether the proposed rule change
should be disapproved. The 45th day after publication of the notice for
this proposed rule change is October 15, 2022. The Commission is
extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change and the
issues raised therein. Accordingly, pursuant to Section 19(b)(2) of the
Act,\5\ the Commission designates November 29, 2022, as the date by
which the Commission shall either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-CboeBZX-2022-045).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-22554 Filed 10-17-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 123 (Tuesday, June 28, 2022)]
[Notices]
[Pages 38414-38415]
[FR Doc No: 2022-13753]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1497]

Bladder Cancer: Developing Drugs and Biologics for Adjuvant
Treatment; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Bladder
Cancer: Developing Drugs and Biologics for Adjuvant Treatment.'' This
guidance is intended to facilitate the development of drugs and
biologics for the adjuvant treatment of muscle-invasive bladder cancer
and provides recommendations for the sponsor on this topic. The
guidance includes recommendations regarding eligibility criteria,
choice of comparator, followup imaging assessments, determination of
disease recurrence, analyses of disease-free survival, and
interpretation of trial results. This guidance finalizes the draft
guidance of the same title issued on October 1, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on June 28, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1497 for ``Bladder Cancer: Developing Drugs and Biologics
for Adjuvant Treatment.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002 or to the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.

Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sundeep Agrawal, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2379, Silver Spring, MD 20993-0002, 301-
348-3914; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Bladder Cancer: Developing Drugs and Biologics for Adjuvant
Treatment.'' This guidance provides recommendations to sponsors
regarding the development of drugs regulated by Center for Drug
Evaluation and Research and Center for Biologics Evaluation and
Research for the adjuvant treatment of muscle-invasive bladder cancer.
The guidance includes recommendations regarding eligibility criteria,
choice of comparator, followup imaging assessments, determination of
disease recurrence, analyses of disease-free survival (DFS), and
interpretation of trial results. Although FDA may consider endpoints
other than DFS for the adjuvant treatment of muscle-invasive bladder
cancer, this guidance is focused on cancer trials with DFS as the
primary efficacy endpoint.
    Adjuvant muscle-invasive bladder cancer clinical trials are an
active area of research. There is significant variability in the
design, conduct, and analysis of these trials, including the
eligibility criteria, radiological disease assessments, the definition
of disease recurrence, and the date used to define the DFS endpoint.
Consistency in these aspects within and across trials may facilitate
interpretation of trial results. These issues were discussed at an FDA-
National Cancer Institute public workshop held on November 28, 2017.
This guidance provides recommendations on these issues to facilitate
adjuvant muscle-invasive bladder cancer clinical trials. This guidance
finalizes the draft guidance entitled ``Bladder Cancer: Developing
Drugs and Biologics for Adjuvant Treatment: issued on October 1, 2020
(85 FR 62309). FDA considered comments received on the draft guidance
as the guidance was finalized. The final guidance includes changes to
improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Bladder Cancer: Developing Drugs and
Biologics for Adjuvant Treatment.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

III. Electronic Access

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

    Dated: June 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13753 Filed 6-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Rules and Regulations]
[Pages 50284-50288]
[FR Doc No: 2018-21746]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0333; FRL-9984-01]

Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances with regional
registrations for residues of flumioxazin in or on Grass, forage and
Grass, hay. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective October 5, 2018. Objections and
requests for hearings must be received on or before December 4, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0333, 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.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main 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 are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0333 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 4, 2018. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0333, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket,

along with more information about dockets generally, is available at
http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8565) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.568(c) be amended by establishing tolerances
with regional registrations for residues of the herbicide flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, including its
metabolites and degradates, determined by measuring only flumioxazin,
in or on Grass, forage at 0.4 parts per million (ppm) and Grass, hay
0.05 ppm. That document referenced a summary of the petition prepared
by Valent, U.S.A. Corporation, the registrant, which is available in
the docket, http://www.regulations.gov. This petition request is
associated with an application to allow use of flumioxazin on grass in
the States of Washington, Idaho, and Oregon. Although comments were
submitted to the docket, none were relevant to the safety of the
tolerances being established in this action.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is
issuing a tolerance that varies from what the petitioner sought. The
reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flumioxazin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flumioxazin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Toxicity associated with flumioxazin includes anemia and effects on
the cardiovascular system and liver. Specifically, alterations in
hemoglobin parameters were observed in rats, as well as increased renal
toxicity in male rats, and increased absolute and relative liver
weights and increased alkaline phosphate values were seen in dogs.
    No evidence of neurotoxicity was seen in male or female rats in the
acute or subchronic neurotoxicity studies. The oral and dermal
developmental rat studies showed evidence of increased quantitative
susceptibility of fetuses, as cardiovascular anomalies (ventral septal
defects) were found. These developmental effects in the offspring were
more severe and seen at doses lower than those that caused parental and
systemic toxicity. The regulatory endpoints for flumioxazin are
protective of this increased susceptibility, however, so there is low
concern and no residual uncertainties for these effects.
    Flumioxazin was negative for mutagenicity in most of the available
studies, however, there were aberrations in a chromosomal aberration
assay. The lack of carcinogenicity in mice and rats permits flumioxazin
to be classified as ``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by flumioxazin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document titled, ``SUBJECT: Flumioxazin. Human
Health Risk Assessment for the Proposed New Uses on Grass (Seed Crop)''
at page 24 in docket ID number EPA-HQ-OPP-2017-0333.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
    A summary of the toxicological endpoints for flumioxazin used for
human risk assessment is discussed in Unit III. B of the final rule
published in the Federal Register of September 21, 2012 (77 FR 58493)
(FRL-9358-3). One additional endpoint has since been identified, i.e.,
the selection of an adult oral endpoint for assessing the aggregate
risks from short-term and intermediate-term oral exposure: An oral
NOAEL of 3 mg/kg/day based on cardiovascular effects in fetuses seen at
the LOAEL of 10 mg/kg/day in the rat developmental study was used,
along with a 10X interspecies uncertainty factor, a 10X intraspecies
uncertainty factor, and a 1X FQPA safety factor. Long-term exposures
(greater than 6 months) are not expected based on the existing
flumioxazin use pattern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary

exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in 40 CFR
180.568. EPA assessed dietary exposures from flumioxazin in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for flumioxazin for females 13-49. In
estimating acute dietary exposure, EPA used food consumption
information from the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This
software uses 2003-2008 food consumption data from the United States
Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008).
As to residue levels in food, EPA assumed tolerance-level residues,
100% crop treated (PCT) for all commodities and DEEM-FCID version 3.16.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID Version 3.16 software which
incorporates 2003-2008 food consumption data from USDA's NHANES/WWEIA.
As to residue levels in food, EPA incorporated tolerance-level residues
and/or 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flumioxazin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flumioxazin. Tolerance-level residues and/or 100
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for flumioxazin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flumioxazin. The estimated drinking water
concentrations (EDWCs) are based on hydrolysis and the residues of
concern for flumioxazin and its major degradates (482-HA, and APF),
expressed as flumioxazin equivalents. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) model,
the EDWCs in surface water for acute exposures are 400 parts per
billion (ppb) for flumioxazin and for chronic exposures are estimated
to be 9.4 ppb, 21.6 ppb, and 110.1 ppb for flumioxazin, 482-HA and APF
degradates, respectively, for a total concentration of 141 ppb. Based
on the Screening Concentration in Ground Water (SCI-GROW) model, for
both acute and chronic (non-cancer) exposures, the EDWCs of 482-HA and
APF are estimated to be 45.27 ppb and 2.66 ppb, respectively, for
ground water. EDWCs of flumioxazin are estimated to be negligible in
ground water for chronic exposures. Estimates of drinking water
concentrations were directly entered into the dietary exposure model as
follows. The peak day zero of 400 ppb for flumioxazin (degradates 482-
HA and APF were not detected) was used to assess the contribution to
drinking water for the acute dietary risk assessment, and the day 30
total of 141 ppb for flumioxazin, 482-HA and APF degradates was used to
assess the contribution to drinking water for the chronic dietary risk
assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Flumioxazin is currently registered for the following uses that
could result in residential exposures: Turf grass, residential lawns,
ornamentals, and aquatic weeds. EPA assessed residential exposure under
the assumption that homeowner handlers wear shorts, short-sleeved
shirts, socks, and shoes, and that they complete all tasks associated
with the use of a pesticide product including mixing/loading, if
needed, as well as the application. Residential handler exposure
scenarios for both dermal and inhalation are considered to be short-
term only, due to the infrequent use patterns associated with homeowner
products.
    EPA uses the term ``post-application'' to describe exposure to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide. Flumioxazin can be used in
many areas that can be frequented by the general population including
residential areas, lakes, and ponds. As a result, individuals can be
exposed by entering these areas if they have been previously treated.
Therefore, short-term and intermediate-term dermal and oral post-
application exposures and risks were assessed for adults and children.
In addition, oral post-application exposures and risks were assessed
specifically for children to be protective of possible hand-to-mouth,
object-to-mouth, and soil ingestion activities that may occur on
treated turf areas. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found flumioxazin to share a common mechanism of
toxicity with any other substances, and flumioxazin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flumioxazin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable

data available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is evidence of
increased quantitative susceptibility of fetuses in the oral and dermal
developmental rat studies, where cardiovascular abnormalities occurred
in the absence of maternal toxicity. The rat reproduction study also
showed evidence of qualitative and quantitative post-natal
susceptibility since reproductive effects in offspring were more severe
and were seen at lower doses than those that caused parental/systemic
toxicity. Even with this observed increased susceptibility, the Agency
has concluded there is a low concern and no residual uncertainties for
pre- and/or postnatal toxicity because the developmental toxicity
NOAELs/LOAELs are well-characterized after oral and dermal exposure,
and the offspring toxicity NOAEL and LOAEL are well characterized in
the reproduction study. Furthermore, the doses and endpoints have been
selected from the developmental and reproductive toxicity studies for
risk assessment of the relevant exposed populations (e.g., pregnant
females and children), with the exception of the chronic dietary
endpoint, for which a chronic study was selected. Therefore, regulatory
endpoints for flumioxazin are protective of the increased
susceptibility and there are no residual concerns for these effects.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for oral and dermal exposures, but retained
the 10X FQPA database uncertainty factor (UF) for inhalation exposure
and risk assessment due to the lack of an inhalation study. That
decision is based on the following findings:
    i. The toxicity database for flumioxazin is incomplete but
sufficient for assessing the toxicity and characterizing the hazard of
flumioxazin due to the absence of an acceptable inhalation study.
Therefore, the Agency is retaining the 10X FQPA safety factor for
assessing inhalation risk.
    ii. There is no indication that flumioxazin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is evidence that flumioxazin may result in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. The Agency concluded that while there is an increased
susceptibility, there is a low concern and no residual uncertainties
for pre-and/or postnatal toxicity because the developmental toxicity
NOAELs/LOAELs are well characterized after oral and dermal exposure;
the offspring toxicity NOAEL and LOAEL are well characterized in the
reproduction study; and the doses and endpoints have been selected from
the developmental and reproductive toxicity studies for the relevant
populations, except for the chronic dietary endpoint, for which a
chronic study was chosen. Therefore, the regulatory endpoints for
flumioxazin are protective of the increased susceptibility seen in the
developmental and reproduction studies, and there are no residual
concerns for these effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessments were
performed based on tolerance-level residues, default processing
factors, and assuming 100 PCT. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to flumioxazin in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
flumioxazin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flumioxazin will occupy 76% of the aPAD for females 13-49 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flumioxazin from food and water will utilize 44% of the cPAD for all
infants <1 year old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
flumioxazin is not expected.
    3. Short-term and intermediate-term risks. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Flumioxazin
is currently registered for uses that could result in short-term and
intermediate residential exposures, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term and intermediate-term residential exposures to
flumioxazin. Since the Agency has determined that the short-term and
intermediate-term points of departure are the same, the aggregate risks
are the same for both short-term and intermediate-term exposures.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term and
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 110 for adult females 13-49 years and MOE of 200 for
children less than 2 years. Because EPA's level of concern for
flumioxazin is a MOE of 100 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flumioxazin is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) method, Valent Method RM30-A-1), is
available to enforce the tolerance expression. The reported method
limits of quantitation and detection (LOQ and LOD) for flumioxazin in/
on plant commodities are 0.02 and 0.01 ppm, respectively.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>;

email address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for flumioxazin in/on grass,
therefore there are no international harmonization issues.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing a tolerance for Grass, forage at 0.40 ppm,
rather than 0.4 ppm, to be consistent with its practice to provide
greater precision about the levels of residues that are permitted by a
tolerance. This is intended to avoid the situation where residues may
be higher than the tolerance level, but as a result of rounding would
be considered non-violative. For example, Grass, forage tolerance
proposed at 0.4 ppm was established at 0.40 ppm, to avoid an observed
hypothetical tolerance at 0.44 ppm being rounded to 0.4 ppm.

V. Conclusion

    Therefore, tolerances with regional registrations are established
for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-
propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, including its metabolites and degradates determined by
measuring only flumioxazin, in or on raw agricultural commodities, in
or on Grass, forage at 0.40 ppm and Grass, hay at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 21, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.568, add alphabetically the commodities ``Grass,
forage'' and ``Grass, hay'' to the table in paragraph (c) to read as
follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
------------------------------------------------------------------------
Grass, forage...............................................        0.40
Grass, hay..................................................        0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-21746 Filed 10-4-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Proposed Rules]
[Pages 12529-12531]
[FR Doc No: 2018-05785]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 107, 171, 172, 173, 174, 177, 178, 179, and 180

[Docket No. PHMSA-2018-0001; Notice No. 2018-01]

Request for Information on Regulatory Challenges to Safely
Transporting Hazardous Materials by Surface Modes in an Automated
Vehicle Environment

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation (DOT).

ACTION: Request for information.

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SUMMARY: The Pipeline and Hazardous Materials Safety Administration
(PHMSA) requests information on matters related to the development and
potential use of automated technologies for surface modes (i.e.,
highway and rail) in hazardous materials transportation. In
anticipation of the development, testing, and integration of Automated
Driving Systems in surface transportation, PHMSA is issuing this
request for information on the factors the Agency should consider to
ensure continued safe transportation of hazardous materials without
impeding emerging surface transportation technologies.

DATES: Interested persons are invited to submit comments on or before
May 7, 2018. Comments received after that date will be considered to
the extent practicable.

ADDRESSES: You may submit comments identified by Docket Number PHMSA-
2018-0001 via any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: To Docket Operations, Room W12-140 on the
ground floor of the West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Instructions: All submissions must include the agency name and
docket number for this notice. Internet users

may access comments received by DOT at: http://www.regulations.gov.
Please note that comments received will be posted without change to:
http://www.regulations.gov including any personal information provided.
    Privacy Act: In accordance with 5 U.S.C. 553(c), the DOT solicits
comments from the public. The DOT posts these comments, without edit,
including any personal information the commenter provides, to http://www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Matthew Nickels, Senior Regulations
Officer (PHH-10), U.S. Department of Transportation, Pipeline and
Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE.,
East Building, 2nd Floor, Washington, DC 20590-0001, Telephone 202-366-
0464, [email protected].

SUPPLEMENTARY INFORMATION:

I. Overview

    The transportation sector is undergoing a potentially revolutionary
period, as tasks traditionally performed by humans only are
increasingly being done, whether in testing or in actual integration,
by automated technologies. Most prominently, ``Automated Driving
Systems'' (ADS) have shown the capacity to drive and operate motor
vehicles, including commercial motor vehicles, as safely and
efficiently as humans, if not more so. Similar technological
developments are also occurring in rail.
    DOT, including PHMSA, strongly encourages the safe development,
testing, and integration of these automated technologies, including the
potential for these technologies to be used in hazardous materials
transportation. Although an exciting and important innovation in
transportation history, the emergence of surface automated vehicles and
the technologies that support them may create unique and unforeseen
challenges for hazardous materials transportation. The safe
transportation of hazardous materials remains PHMSA's top priority, and
as the development, testing, and integration of surface automated
vehicles into our transportation system continues, PHMSA must ensure
the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180)
framework sufficiently takes into account these new technological
innovations.
    The purpose of this request for information is to obtain public
comment on how the development of automated technologies may impact the
HMR, and on the information PHMSA should consider when determining how
to best ensure the HMR adequately account for surface automated
vehicles.\1\ In anticipation of the role surface automated vehicles and
the technologies that support them may play on transportation, the
movement of freight, and commerce, PHMSA requests comments from the
public and interested stakeholders--including entities engaged in the
development, testing, and integration of these technologies--on the
potential future incompatibilities between the hazardous materials
transportation requirements in the HMR and a surface transportation
system that incorporates automated vehicles.
---------------------------------------------------------------------------

    \1\ In this notice, PHMSA is not seeking comment on how advances
in aviation or maritime technology could affect the transportation
of hazardous materials, though the Agency is considering future
notices on those issues.
---------------------------------------------------------------------------

II. PHMSA's Safety Mission and Regulatory Objectives

    PHMSA is an operating administration within DOT established in 2004
by the Norman Y. Mineta Research and Special Programs Improvement Act
(Pub. L. 108-426). PHMSA's mission is to protect people and the
environment by advancing the safe transportation of energy and other
hazardous materials that are essential to our daily lives. To achieve
this mission, PHMSA establishes national policy, sets and enforces
standards, educates, and conducts research to prevent hazardous
materials incidents--often collaborating closely with other Federal
agencies, operating administrations, and transportation modes.
    Federal hazardous materials law authorizes the Secretary to
``prescribe regulations for the safe transportation, including
security, of hazardous materials in intrastate, interstate, and foreign
commerce.'' 49 U.S.C. 5103(b)(1). The Secretary has delegated this
authority to PHMSA in 49 CFR 1.97(b). The HMR are designed to achieve
three primary goals: (1) Help ensure that hazardous materials are
packaged and handled safely and securely during transportation; (2)
provide effective communication to transportation workers and emergency
responders of the hazards of the materials being transported; and (3)
minimize the consequences of an accident or incident should one occur.
The hazardous materials regulatory system is a risk management system
that is prevention-oriented and focused on identifying safety or
security hazards and reducing the probability and consequences of a
hazardous material release.
    Under the HMR, hazardous materials are categorized into hazard
classes and packing groups based on analysis of and experience with the
risks they present during transportation. The HMR: (1) Specify
appropriate packaging and handling requirements for hazardous materials
based on this classification and require a shipper to communicate the
material's hazards through the use of shipping papers, package marking
and labeling, and vehicle placarding; (2) require shippers to provide
emergency response information applicable to the specific hazard or
hazards of the material being transported; and (3) mandate training
requirements for persons who prepare hazardous materials for shipment
or transport hazardous materials in commerce. The HMR also include
operational requirements applicable to each mode of transportation.
    As such, PHMSA--in continued collaboration with the Federal Motor
Carrier Safety Administration and the Federal Railroad Administration--
seeks information regarding the design, development, and potential use
of automated transportation systems to safely transport hazardous
materials by surface mode in compliance with the HMR, and to identify
requirements within the HMR which may impede the integration of this
technology.

III. Special Permit Program Allows Regulatory Flexibility To Foster
Innovation

    PHMSA safely incorporates technological innovation through its
special permit (SP) program. SPs set forth alternative requirements--or
a variance--to the requirements in the HMR in a manner that achieves an
equivalent level of safety to that required under the regulations, or
if a required safety level does not exist, that is consistent with the
public interest. PHMSA's Approvals and Permits Division is responsible
for the issuance of DOT SPs. Specifically, SPs are issued by PHMSA
under 49 CFR part 107, subpart B.
    The HMR often provide performance-based standards and, as such,
provide the regulated community with some flexibility in meeting safety
requirements. Even so, not every transportation situation can be
anticipated and covered under the regulations. The hazardous materials
community is at the cutting edge of development of new materials,
technologies, and innovative ways of moving hazardous materials.
Innovation

strengthens our economy, and new technologies and operational
techniques may enhance safety. Thus, SPs provide a mechanism for
testing and using new technologies, promoting increased transportation
efficiency and productivity, and ensuring global competitiveness
without compromising safety. SPs enable the hazardous materials
industry to safely, quickly, and effectively integrate new products and
technologies into production and the transportation stream.

IV. Additional DOT Guidance

    PHMSA requests information related to the development and potential
use of surface automated vehicles and the technologies that support
them in hazardous materials transportation by highway or rail. For
additional background on ADS for motor vehicles, PHMSA notes that DOT
and the National Highway Traffic Safety Administration (NHTSA) released
guidance in the Automated Driving Systems 2.0: A Vision for Safety,\2\
on September 12, 2017. Further, NHTSA issued a notice [September 15,
2017; 82 FR 43321] making the public aware of the guidance and seeking
comment. This voluntary guidance, among other things, describes the
levels of ``Automated Driving Systems'' for on-road motor vehicles
developed by SAE International (see SAE J3016, September 2016) and
adopted by DOT.
---------------------------------------------------------------------------

    \2\ See https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/13069a-ads2.0_090617_v9a_tag.pdf
---------------------------------------------------------------------------

    The SAE definitions divide vehicles into levels based on ``who does
what, when.'' Generally:
     At SAE Level 0, the driver does everything.
     At SAE Level 1, an automated system on the vehicle can
sometimes assist the driver conduct some parts of the driving task.
     At SAE Level 2, an automated system on the vehicle can
actually conduct some parts of the driving task, while the driver
continues to monitor the driving environment and performs the rest of
the driving task.
     At SAE Level 3, an automated system can both actually
conduct some parts of the driving task and monitor the driving
environment in some instances, but the driver must be ready to take
back control when the automated system requests.
     At SAE Level 4, an automated system can conduct the
driving task and monitor the driving environment, and the driver need
not take back control, but the automated system can operate only in
certain environments and under certain conditions.
     At SAE Level 5, the automated system can perform all
driving tasks, under all conditions that a driver could perform them.

V. Questions

    PHMSA requests comments on the implications of the development,
testing, and integration of automated technologies for surface modes
(i.e., highway and rail) on both the HMR and the general transport of
hazardous materials.
    Specifically, PHMSA asks:
    1. What are the safety, regulatory, and policy implications of the
design, testing, and integration of surface automated vehicles on the
requirements in the HMR? Please include any potential solutions PHMSA
should consider.
    2. What are potential regulatory incompatibilities between the HMR
and a future surface transportation system that incorporates automated
vehicles? Specific HMR areas could include but are not limited to:

(a) Emergency response information and hazard communication
(b) Packaging and handling requirements, including pre-transportation
functions
(c) Incident response and reporting
(d) Safety and security plans (e.g., en route security)
(e) Modal requirements (e.g., highway and rail)

    3. Are there specific HMR requirements that would need
modifications to become performance-based standards that can
accommodate an automated vehicle operating in a surface transportation
system?
    4. What automated surface transportation technologies are under
development that are expected to be relevant to the safe transport of
hazardous materials, and how might they be used in a surface
transportation system?
    5. Under what circumstances do freight operators envision the
transportation of hazardous materials in commerce using surface
automated vehicles within the next 10 years?
    (a) To what extent do the HMR restrict the use of surface automated
vehicles in the transportation of hazardous materials in non-bulk
packaging in parcel delivery and less-than-truckload freight shipments
by commercial motor vehicles?
    (b) To what extent do the HMR restrict the use of surface automated
vehicles in the transportation of hazardous materials in bulk packaging
by rail and commercial motor vehicles?
    6. What issues do automated technologies raise in hazardous
materials surface transportation that are not present for human drivers
or operators that PHMSA should address?
    7. Do HMR requirements that relate to the operation of surface
automated vehicles carrying hazardous materials present different
challenges than those that relate to ancillary tasks, such as
inspections and packaging requirements?
    8. What solutions could PHMSA consider to address potential future
regulatory incompatibilities between the HMR and surface automated
vehicle technologies?
    9. What should PHMSA consider when reviewing applications for
special permits seeking regulatory flexibility to allow for the
transport of hazardous materials using automated technologies for
surface modes?
    10. When considering long-term solutions to challenges the HMR may
present to the development, testing, and integration of surface
automated vehicles, what information and other factors should PHMSA
consider?
    11. What should PHMSA consider when developing future policy,
guidance, and regulations for the safe transportation of hazardous
materials in surface transportation systems?

    Signed in Washington, DC, on March 16, 2018.
Drue Pearce,
Deputy Administrator, Pipeline and Hazardous Materials Safety
Administration.
[FR Doc. 2018-05785 Filed 3-21-18; 8:45 am]
 BILLING CODE 4910-60-P