Tag: OSTP

White House OSTP Releases PFAS Federal R&D Strategic Plan

The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal strategy and implementation plan for addressing the strategic areas identified in the 2023 Per- and Polyfluoroalkyl Substances (PFAS) Report (PFAS Report). The Strategic Plan is intended to be a companion document to the PFAS Report. The activities described in the Strategic Plan are reviewed through the Office of Management and Budget (OMB) annual budget process and subject to available resources.

Background

As reported in our March 16, 2023, blog item, the PFAS Report provides an analysis of the state of the science of PFAS and information that will be used to direct the development of a federal strategic plan. The PFAS Report focuses on the current science of PFAS as a chemical class, identifies scientific consensus, and portrays uncertainties in the scientific information where consensus is still sought. The PFAS Report identifies four key strategic areas that, when addressed, will generate actionable information to address PFAS: removal, destruction, or degradation of PFAS; safer and environmentally friendlier alternatives; sources and pathways of exposure to PFAS; and toxicity of PFAS. The gaps and opportunities identified in the PFAS Report were used to develop the Strategic Plan.

Strategic Plan

Based on the four strategic areas presented in the 2023 PFAS Report, the PFAS ST identified four strategic goals that will drive federal research and development (R&D) efforts regarding PFAS:

  • Provide relevant, high-quality scientific data that increase the understanding of PFAS exposure pathways to inform federal decisions that reduce risks to human health and the environment;
  • Effectively and equitably communicate federal work and results regarding PFAS R&D through engagement with impacted communities and federal, Tribal, state, and local agencies;
  • Identify research and technologies to address PFAS contamination and mitigate the adverse impacts on communities; and
  • Generate information that facilitates informed procurement decisions by federal agencies, manufacturers, and consumers regarding products that contain or use PFAS and PFAS alternatives to reduce adverse human health and environmental effects.

According to the Strategic Plan, the PFAS ST identified five R&D strategies within the strategic research areas that address the identified knowledge gaps. The R&D strategies and select tasks to achieve the objectives within each strategy include:

  • Understand PFAS exposure pathways to individuals and communities:
    • Further characterize potential PFAS exposures in the built environment, including schools, workplaces, and other indoor/household environments. According to the Strategic Plan, this would include the co-occurrence and use of consumer products and understanding the lifecycle of products with regard to PFAS exposure;
    • Initiate studies regarding PFAS co-exposure and potential interactions with other contaminants (including other PFAS) in environmental samples, such as nano- and microplastics, petroleum constituents, metals, pesticides, and pharmaceuticals;
    • Initiate and continue studies of the physical-chemical properties of PFAS and mixtures of PFAS;
    • Investigate additional pathways and routes of exposure, such as direct contact, dermal absorption, oral ingestion, and inhalation from indoor and outdoor environments (residential, consumer, and occupational exposures); and
    • Develop and support studies of PFAS exposures in indoor environments through collection of dust, air, consumer products, and other media where biomonitoring may also be conducted;
  • Address current PFAS measurement challenges through the development of standards, advanced sampling, and analytical methodologies:
    • Develop and refine analytical methods and data collection methods to evaluate PFAS content, migration, and emissions from consumer, commercial, and industrial products, and their impact on workplace and indoor environments;
    • Develop testing programs and methods related to quantifying PFAS content, migration, and emissions in animal/livestock feed, food and food packaging, indoor exposure (dust, home/office materials), workplace settings, and consumer products; and
    • Develop and validate real-time, rapid, and remote PFAS screening methods using analytical sensors, PFAS proxies, passive sampling devices, and other novel technologies for the detection of PFAS in media;
  • Understand the toxicological mechanisms, human and environmental health effects, and risks of PFAS exposure:
    • Develop scientifically supported classification schemes for PFAS with respect to adverse impacts on human health and the environment;
    • Develop and support research regarding the human toxicity and ecotoxicity testing of PFAS as mixtures with PFAS and other co-occurring chemicals;
    • Support research to understand further the mechanism of action of PFAS toxicity, advance development of adverse outcome pathways, and understand the impact of PFAS mixture toxicities when evaluating cumulative health effects;
    • Develop and support epidemiological studies designed to identify communities near significant sources of PFAS contamination that may have environmental justice concerns, including occupationally exposed populations and populations, communities, and/or lifestages that are more susceptible to PFAS exposure or adverse health outcomes;
    • Explore the development of a federal data-sharing strategy to use interagency toxicological and epidemiological data to determine human health endpoints of concern from PFAS exposure; and
    • Develop classification strategies that enable grouping of PFAS by hazard identification, exposure assessment, and dose-response studies in support of risk assessments;
  • Develop, evaluate, and demonstrate technologies for the removal, destruction, and disposal of PFAS:
    • Continue to support the foundational research that advances technologies for the destruction of PFAS by both thermal and non-thermal approaches;
    • Support the implementation of removal and destruction technologies that apply to discharge and releases at the point of manufacturing; and
    • Develop and implement models to evaluate technology performance, short-term and long-term costs, energy demands, scalability, and the composition of treated materials that are released to the environment;
  • Identify PFAS alternatives and evaluate their human health and environmental effects:
    • Engage with academic and private sector industrial researchers to support the development of novel, less toxic alternative chemistries and processes for sustainable PFAS alternatives;
    • Identify and evaluate critical and essential uses of PFAS within individual agencies and sectors;
    • Develop an interagency-aligned evaluation framework for prioritizing research on specific PFAS alternatives that includes considerations regarding sustainability; performance; viability and timeframe to transition; dependency on foreign sources of materials; criticality of the current product to national security, critical infrastructure, climate change mitigation, and public health; and criticality of the need for a replacement product or process;
    • Support research to advance sustainable manufacturing and circularity of PFAS-based processes and products to preserve current critical and essential uses, which will enable an orderly transition to PFAS alternatives in critical manufacturing sectors that are dependent on PFAS;
    • Develop a database of the current commercial inventory of alternative materials and products with relevant chemical and toxicological information, manufacturer production capacity, and performance comparison of the alternatives to PFAS-containing materials and products; and
    • Continue to assess human health and environmental effects posed by alternative materials and products for use in comparison to other product formulations, including PFAS-containing product formulations.

Commentary

Bergeson & Campbell, P.C. (B&C®) acknowledges that OSTP’s PFAS Strategy may benefit from the U.S. Environmental Protection Agency’s (EPA) regulatory activities under the Toxic Substances Control Act (TSCA) and other initiatives. We provide below representative examples of these activities.

Between 2022 and 2024, EPA issued TSCA Section 4 test orders requiring manufacturers and/or processors to perform various studies on four PFAS (i.e., 6:2 fluorotelomer sulfonamide betaine [6:2 FTSB], trifluoro(trifluoromethyl)oxirane [HFPO], 2,3,3,3-tetrafluoro-2-heptafluoropropoxy) propanoyl fluoride [HFPO-DAF], and 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-Heptadecafluoro-N-(2-hydroxyethyl)-N-methyloctane-1-sulfonamide [NMeFOSE]).

EPA also intends on initiating ten additional TSCA Section 4 test orders per year on PFAS between fiscal year (FY) 2024 and FY 2026 (i.e., October 1, 2024-September 30, 2027). EPA’s activities under TSCA Section 4 may lead to the development of data that provide a better understanding of the human health and environmental effects of specific types of PFAS.

The TSCA Section 8(a)(7) rule on the reporting and recordkeeping of manufacture and import of PFAS will provide additional information on PFAS uses, production volumes, disposal, exposures, and hazards. In addition, EPA’s publication of its updated PFAS category analysis may help frame how to use data on PFAS for which testing has been (or is in the process of being) completed to fill data gaps on related PFAS.

Further, EPA’s Office of Research and Development (ORD) and Office of Land Use and Emergency Management (OLEM) have made significant contributions on analytical methods for detecting PFAS in various media and guidance for destroying and disposing of PFAS and PFAS-containing materials, respectively. The TSCA Section 8(a)(7) information along with EPA’s advancements with identifying PFAS in environmental media may aid with identifying those PFAS and the associated uses that lead to the greatest environmental releases.

Collectively, EPA’s activities on PFAS will advance the objectives of OSTP’s PFAS Strategy. This information may also aid with differentiating the types of PFAS that present the greatest concerns to human health and the environment versus those chemistries that do not. After all, many chemical substances, including pharmaceuticals and pesticides, meet one or more of the existing definitions for PFAS and have clear public health benefits, yet do not present the same concerns as those PFAS that have significant concerns (e.g., perfluorooctanoic acid).

©2024 Bergeson & Campbell, P.C.
For more news on PFAS Federal R&D Strategic Plans, visit the NLR Environmental Energy Resources section.

Biden Administration Initiates Ocean Justice Strategy

On June 8, 2023, the White House Council on Environmental Quality (CEQ) and Office of Science and Technology Policy (OSTP), on behalf of the Ocean Policy Committee (OPC), announced the development of a new “Ocean Justice Strategy.” This federal government-wide initiative marks the latest in a long series of Biden administration efforts to promote environmental justice (EJ). The first step is a request for public input through July 24, 2023.

Overview

    • Per CEQ, the Ocean Justice Strategy aims to identify barriers and opportunities to incorporate environmental justice principles into the federal government’s ocean-related activities. It will encompass all recent Biden administration Executive Orders and policies relating to environmental justice, including the Ocean Climate Action Plan. The Strategy will serve as a guide to the federal government’s objectives for guiding “ocean justice” activities. It will propose “equitable and just practices to advance safety, health, and prosperity for communities residing near the ocean, the coasts, and the Great Lakes.”
    • The OPC, a Congressionally-created office dedicated to developing federal ocean policy, will draft the Ocean Justice Strategy with input from stakeholders, including Tribes, state and local governments, the private sector, and the public.
    • The Biden Administration previewed its support for ocean justice last year when it announced a commitment to extending environmental justice efforts to coastal and marine contexts. NOAA Fisheries followed suit by releasing its first-ever Equity and Environmental Justice Strategy, which puts equity and environmental justice at the forefront of their effort to steward the nation’s ocean resources and habitats.
    • The Strategy and its underlying EJ-based principles could lead to future policy changes, including for industries such as offshore energy, real estate, shipping, ports, and fisheries. This new effort is somewhat unique among EJ initiatives in that it targets activities that inherently occur along the nation’s coasts or far away from communities. The Strategy could emerge in a variety of directions, from identifying favored or disfavored ocean-based activities to layering additional processes for certain types of proposed projects.

Request for Public Input

OPC seeks public input on the following topics to develop the Ocean Justice Policy:

    • Definitions (namely, what is “ocean justice”)
    • Barriers to ocean justice
    • Opportunities for ocean justice
    • Research and knowledge gaps
    • Tools and practices (e.g., how to use existing tools such as CEJST, EJScreen, and EnviroAtla, in addition to developing new tools)
    • Partnerships and collaboration with external stakeholders
    • Any additional considerations

In addition to these comments, OPC will consider comments submitted in response to its previous request for information on the Ocean Climate Action Plan to inform the development of the Ocean Justice Strategy.

© 2023 Beveridge & Diamond PC

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Office of Science and Technology Policy Requests Public Input on Biotechnology Regulation

  • The Office of Science and Technology Policy (OSTP) issued a request for information (RFI) today in which it invites public comment on the Coordinated Framework for the Regulation of Biotechnology (the “Coordinated Framework”).
  • The Coordinated Framework, which is a Federal regulatory policy for ensuring the safety of biotechnology products, was first issued in 1986, updated in 1992— to affirm that federal regulation should focus on characteristics of the product and the environment into which it being introduced, and not on the process by which it is produced—and then updated again in 2017 to clarify the roles of EPA, FDA, and USDA. And, in September of this year, Executive Order 14081 directed the three agencies to clarify and streamline regulations to support the safe of use of biotechnology products.
  • Accordingly, the RFI requests comment on seven questions related to the Coordinated Framework. The questions include a request for comment on identification of any regulatory gaps, inefficiencies, or uncertainties; data or information to improve any identified issues; and new or emerging biotechnology products that the agencies should be prepared to address. Comments to the RFI are due by February 3, 2023. Also, on January 12, 2023, OTSP will host a virtual event in which it will listen to public feedback on the RFI.

Article By Food and Drug Law at Keller and Heckman

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© 2022 Keller and Heckman LLP

All Federal Research Agencies to Update Public Access Policies

On 25 August 2022, the Office of Science and Technology Policy (OSTP) released a guidance memorandum instructing federal agencies with research and development expenditures to update their public access policies. Notably, OSTP is retracting prior guidance that gave discretion to agencies to allow a 12-month embargo on the free and public release of peer-reviewed publications, so that federal funded research results will be timely and equitably available at no cost. The memo also directs affected agencies to develop policies that:

  1. Ensure public access to scientific data, even if not associated with peer-reviewed publications;
  2. Ensure scientific and research integrity in the agency’s public access by requiring publication of the metadata, including the unique digital persistent identifier; and
  3. Coordinate with OSTP to ensure equitable delivery of federally funded research results and data.

KEY COMPONENTS OF GUIDANCE:

Updating Public Access Policies

Federal agencies will need to develop new, or update existing, public access plans, and submit them to OSTP and the Office of Management and Budget (OMB). Deadlines for submission are within 180 days for federal agencies with more than US$100 million in annual research and development expenditures, and within 360 days for those with less than US$100 million in expenditures.

Agencies will need to ensure that any peer-reviewed scholarly publication is free and available by default in agency-designated repositories without any embargo or delay following publication. Similarly, OSTP expects the access polices to address publication of any other federally funded scientific data, even if not associated with peer-reviewed scholarly publications. As a concession, federal agencies are being asked to allow researchers to include the “reasonable publication costs and costs associated with submission, curation, management of data, and special handling instructions as allowable expenses in all research budgets.1”

Ensuring Scientific Integrity

To strengthen trust in governmentally funded research, the new or updated policies must transparently communicate information designed to promote OSTP’s research integrity goals. Accordingly, agencies are instructed to collect and make appropriate metadata available in their public access repositories, including (i) all author and co-author names, affiliations, and source of funding, referencing their digital persistent identifiers, as appropriate; (ii) date of publication; and (iii) a unique digital persistent identifier for research output. Agencies should submit to OSTP and OMB (by 31 December 2024) a second update to their policies specifying the approaches taken to implement this transparency, and publish such policy updates by 31 December 2026, with an effective date no later than one year after publication of the updated plan.

IMPLICATIONS FOR THE NATIONAL INSTITUTES OF HEALTH (NIH), OTHER FEDERAL AGENCIES, AND THEIR GRANTEES

The NIH is expected to update its Public Access Policy, potentially along with its Data Management and Sharing Policy to conform with the new OSTP guidance. Universities, academic medical centers, research institutes, and federally funded investigators should monitor agency publications of draft and revised policies in order to update their processes to ensure continued compliance.

In doing so, affected stakeholders may want to consider and comment to relevant federal agencies on the following issues in their respective public access policy development:

  • Federal agency security practices to prevent foreign misappropriation of research data;
  • Implications for research misconduct investigations and research integrity;
  • Any intellectual property considerations without a 12-month embargo, especially to the extent this captures scientific data not yet published in a peer-review journal; and
  • Costs allowable research budgets to support these data management and submission expectations.

1 Office of Science and Technology Policy, Memorandum for the Heads of Executive Departments and Agencies: Ensuring Free, Immediate, and Equitable Access to Federally Funded Research at p. 5 (25 August 2022) available at https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf

Article By Cindy L. Ortega Ramos and Rebecca M. Schaefer of K&L Gates

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