[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35097-35099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information on Drinking Water Contaminants of 
Emerging Concern for the National Emerging Contaminant Research 
Initiative; Reopening of Comment Period

AGENCY: National Institutes of Health, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Department of Health and Human Services (HHS), National 
Institutes of Health (NIH), National Institute of Environmental Health 
Sciences (NIEHS), on behalf of the Office of Science and Technology 
Policy (OSTP), published a Notice in the Federal Register on May 25, 
2021, requesting input from all interested parties on research needed 
to identify, analyze, monitor, and mitigate drinking water contaminants 
of emerging concern (DW CECs). Comments provided through this Request 
for Information (RFI) will inform the development of a National 
Emerging Contaminant Research Initiative (NECRI). The NECRI will be the 
precursor to Federal coordination of DW CEC research; and agencies will 
publish external grant solicitations that align with the goals of the 
NECRI. The purpose of this Notice is to provide a reopening of the 
comment period for an additional 30 days to provide more time to 
receive comments by interested parties.

DATES: This Request for Information has been reopened for public 
comment for 30 days. Responses must be received by August 2, 2021 to 
ensure consideration.

ADDRESSES: Responses to this RFI may be submitted online to 
<a href="/cdn-cgi/l/email-protection#c987808c819a8a8c8a89a7a0a1e7aea6bf"><span class="__cf_email__" data-cfemail="652b2c202d36262026250b0c0d4b020a13">[email protected]</span></a>. Email submissions should be machine-readable [PDF, 
Word] and should not be copy-protected. Submissions should include 
``RFI Response: Drinking Water Contaminants of Emerging Concern'' in 
the subject line of the email.
    Response to this RFI is voluntary. Each individual or organization 
is requested to submit only one response. Please feel free to respond 
to one or as many statements as you choose. Responses must not exceed 
10 pages in 12 point or larger font (exclusive of attachments), with a 
page number provided on each page. Responses should include the name of 
the person(s) or organization(s) filing the response.
    Responses containing references, studies, research, and other 
empirical data that are not widely published should include copies of 
or electronic links to the referenced materials. Responses containing 
profanity, vulgarity, threats, or other inappropriate language or 
content will not be considered.
    Comments submitted in response to this RFI are subject to the 
Freedom of Information Act (FOIA). Responses to this RFI may also be 
posted, without change, on a Federal website. Therefore, we request 
that any proprietary information, copyrighted information, or 
personally identifiable information be omitted from your response to 
this RFI.
    This RFI is for planning purposes only and should not be construed 
as a solicitation for applications or proposals, or as an obligation in 
any way on the part of the United States Federal government. The 
Federal government will not pay for the preparation of any information 
submitted or for the government's use. Additionally, the government 
cannot guarantee the confidentiality of the information provided.

FOR FURTHER INFORMATION CONTACT: Questions about this request for 
information should be directed to Christopher P. Weis, Ph.D., DABT, 
National Institute of Environmental Health Sciences (NIEHS), Telephone: 
301-496-3512, Email: <a href="/cdn-cgi/l/email-protection#de9db6acb7adaab1aeb6bbacf089bbb7ad9eb0b7b6f0b9b1a8"><span class="__cf_email__" data-cfemail="15567d677c66617a657d70673b42707c66557b7c7d3b727a63">[email protected]</span></a>; or David M. Balshaw, 
National Institute of Environmental Health Sciences (NIEHS), Telephone: 
984-287-3234, Email: <a href="/cdn-cgi/l/email-protection#1d7f7c716e757c6a5d737478756e33737475337a726b"><span class="__cf_email__" data-cfemail="4022212c33282137002e292528336e2e29286e272f36">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS), National Institutes of Health (NIH), National Institute of 
Environmental Health Sciences (NIEHS), on behalf of the Office of 
Science and Technology Policy (OSTP), published a Notice in the Federal 
Register on May 25, 2021, pages (28120-28121), 86 FR 28120, requesting 
input from all interested parties on research needed to identify, 
analyze, monitor, and mitigate drinking water contaminants of emerging 
concern (DW

[[Page 35098]]

CECs). In accordance with 42 U.S.C. 285l, of the Public Health Service 
Act, as amended, NIEHS is reopening the comment period for 30 days to 
allow additional time to receive comments by interested parties. 
Drinking water contaminants of emerging concern (DW CECs) are newly 
identified or re-emerging manufactured or naturally occurring physical, 
chemical, biological, radiological, or nuclear materials that may cause 
adverse effects to human health or the environment and do not currently 
have a national primary drinking water regulation. Through this RFI, 
NIH/NIEHS seeks input from non-governmental entities (e.g., industry, 
academia, civil society), State and local governments, and other 
institutions with scientific and material interest in DW CEC research. 
Comments provided in response to this RFI will inform the development 
of a National Emerging Contaminant Research Initiative (NECRI) for 
protection of U.S. drinking water quality. Responses may also be used 
to address requests from the 2021 National Defense Authorization Act to 
identify research questions and priorities in the area of sustainable 
chemistry. The initiative will build on the National Science and 
Technology Council's (NSTC) cross-agency Plan for Addressing Critical 
Research Gaps Related to Emerging Contaminants in Drinking Water 
published in 2018. The NECRI will be the precursor to Federal 
coordination of DW CEC research; and, in compliance with the NDAA for 
Fiscal Year 2020, Title LXXIII, Subtitle D, Sections 7341 and 7342, 
agencies will ``issue a solicitation for research proposals consistent 
with the Federal research strategy and that agency's mission.''
    Contaminants of emerging concern may be present in drinking water 
and in some cases have been shown to cause adverse effects on human 
health. The 2020 NDAA instructed Office of Science and Technology 
Policy (OSTP) to establish the NECRI to improve the ``identification, 
analysis, monitoring, and treatment methods of contaminants of emerging 
concern'' and subsequently develop ``any necessary program, policy, or 
budget'' to further DW CEC research. The 2020 NDAA also directs the 
Administrator of the U.S. Environmental Protection Agency (EPA) and the 
Secretary of Health and Human Services (HHS) to establish an 
Interagency Working Group on Contaminants of Emerging Concern (CEC IWG) 
to facilitate coordination of Federal research on CEC. OSTP 
collaborated with the CEC IWG to identify approaches, tools, and 
methods to accelerate DW CEC research, and metrics and indicators to 
assess progress in reaching the goals of the NECRI.

Information Requested

    This RFI requests feedback on two sections: The need for 
coordination of efforts and the scientific focus of a DW CEC effort. 
Respondents are free to address one or both of the sections listed 
below and respond to as many items in each section as they choose, 
while remaining within the 10-page limit, exclusive of attachments.
    Section 1--Feedback on Improving and Coordinating DW CEC Efforts: 
This RFI requests feedback on methods to focus and coordinate DW CEC 
research efforts. Please consider how U.S. Government and external 
stakeholder action could contribute to DW CEC research, take advantage 
of emerging science and technology opportunities, measure outcomes, and 
develop a DW CEC research initiative with the goal to provide safe 
drinking water for the American people. Please comment on:
    1. Barriers that prevent or limit you or your organization's DW CEC 
research capabilities and success.
    2. Potential opportunities to improve coordination and partnership 
among public and private entities participating in DW CEC research and 
prevent unnecessarily duplicative efforts.
    3. The types of outreach efforts most useful to communicate DW CEC 
research results for impacted Federal, State, local, and Tribal 
communities. Please provide examples where possible.
    4. Metrics or indicators that you or your organization adopted to 
measure the success of your DW CEC research or other related research 
efforts.
    5. Metrics or indicators that would be valuable in measuring the 
success of a National DW CEC research initiative.
    6. As an affected community member, the most significant concerns 
and recommendations for DW CECs.
    Section 2--Feedback on DW CEC Research Areas: This RFI requests 
feedback on needs for broad areas of DW CEC research (detailed below) 
and research needed for shaping the NECRI.

DW CEC Research Areas

    Below are descriptions of four areas of DW CEC research identified 
by the CEC IWG. When submitting your feedback, please indicate which DW 
CEC research area(s) you are responding to.

Research Area 1: Exposure

    Exposure to DW CECs can occur through ingestion, inhalation, or 
dermal routes. Exposure-related research includes contaminant 
identification and monitoring from source-to-tap and informs downstream 
efforts to understand the biological effects of CEC exposures, 
characterize their risk, and develop mitigation tools. Monitoring can 
be performed routinely to assess water composition, during acute 
exposure events, or to estimate the effect of CEC mitigation efforts. 
Exposure science includes efforts to estimate the type and 
concentration of contaminants through a range of activities from 
targeted analysis of specific CEC, non-targeted analysis for the 
discovery of unknown CEC, and modeling activities. Please include 
thoughts on identification and measurement tools, such as sensors, to 
conduct analyses.

Research Area 2: Human Health and Environmental Effects

    Emerging contaminants may cause adverse effects on human health and 
the environment. Biological effects research encompasses the 
identification and characterization of these adverse effects, including 
factors that influence susceptibility to disease or disfunction. 
Research tools may include in-silico and receptor-based approaches, 
predictive modeling, new toxicological assessments, and data analytics 
strategies. In the context of this research initiative, environmental 
effects research considers indicators of adverse human health effects.

Research Area 3: Risk Characterization To Inform Risk Mitigation

    Risk characterization synthesizes available information and 
communicates uncertainty about exposure, biological effects, and other 
relevant considerations to inform risk mitigation actions. Risk 
mitigation actions include research into preventative approaches such 
as source reduction. Sustainable chemistry efforts may also fall into 
risk mitigation actions. In addition, treatments, technological 
development and application, and other interventions may also be 
considered to reduce or otherwise mitigate risk for individual, 
mixtures, or classes of CEC.

Research Area 4: Risk Communication

    Risk communication relays information to relevant groups about 
risks to human health and actions that could address those risks. The 
scope of relevant groups includes those affected by exposures, the 
general public, decision makers, scientists, industry, and other 
technical experts. Risk communication research includes techniques and 
media formats used to inform stakeholder groups and studies on the 
psychosocial aspects of risks,

[[Page 35099]]

such as general perceptions of risk, the adoption of risk reduction 
behaviors, and perceptions framed by scientific controversy or 
misinformation.
    The following statements are provided to obtain feedback to fill 
existing gaps in DW CEC knowledge and practice in these research areas. 
Please comment on:
    1. The critical, impactful research questions and topics that 
should be addressed in order to better protect American public health 
in regard to DW CEC.
    2. Research priorities within each of the four areas described 
below.
    3. New or innovative tools, technologies, software, modeling, 
methods, data/information sharing, etc. that should be developed or 
employed to address these research areas.
    This RFI is for planning purposes only and should not be construed 
as a solicitation for applications or proposals, or as an obligation in 
any way on the part of the United States Federal government. The 
Federal government will not pay for the preparation of any information 
submitted or for the government's use.
    Additionally, the government cannot guarantee the confidentiality 
of the information provided.

    Dated: June 28, 2021.
Christopher P. Weis,
Toxicology Liaison, National Institute of Environmental Health 
Sciences, National Institutes of Health.
[FR Doc. 2021-14150 Filed 6-30-21; 8:45 am]
BILLING CODE 4140-01-P


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