By Lynn L. Bergeson and Carla N. Hutton
On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from fluorinated polyethylene food containers. The purpose of the request is to ensure that FDA has current information to support its review of the use of fluorinated polyethylene containers used in food contact applications to help ensure that this use continues to be safe. According to the RFI, FDA may use submitted information to update dietary exposure estimates and safety assessments for the authorized food contact use of fluorinated polyethylene. Either electronic or written comments and scientific data and information are due October 18, 2022.
The RFI notes that tests performed by the U.S. Environmental Protection Agency (EPA) found that certain PFAS can form and migrate from some fluorinated high-density polyethylene (HDPE, which is a type of polyethylene) containers into the pesticide within the containers. EPA’s testing was conducted on containers that are not FDA-regulated, specifically containers intended to hold mosquito-controlling pesticides. The RFI states that EPA’s testing raises questions about the potential for PFAS to form and migrate from fluorinated polyethylene containers that are intended for food contact use. As such, FDA is interested in obtaining information on current food uses of fluorinated polyethylene containers, as well as information on current manufacturing processes for these containers and any analytical testing information about substances that may migrate from fluorinated polyethylene containers to food. More information on EPA’s testing is available in our October 4, 2021, blog item.
By Lynn L. Bergeson and Carla N. Hutton
On July 13, 2022, the White House Office of Science and Technology Policy (OSTP) requested input from all interested parties to identify data gaps in research and development (R&D) regarding several aspects of per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 41749. This information will be used to inform a strategic plan for federal coordination of PFAS R&D and, in compliance with Section 332 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (NDAA), the interagency strategy team on PFAS will also develop an implementation plan for federal agencies.
For purposes of the RFI, the term PFAS has the definition provided in NDAA Section 332(g)(1): “(A) man-made chemicals of which all of the carbon atoms are fully fluorinated carbon atoms; and (B) man-made chemicals containing a mix of fully fluorinated carbon atoms, partially fluorinated carbon atoms, and nonfluorinated carbon atoms.” The RFI states that examples of products that use PFAS include food contact materials (e.g., packaging, cookware), stain- and water-repellant fabrics and carpets, and firefighting foams. PFAS may be present in water, soil, air, food, and other materials. According to the RFI, “[r]esearch has shown that PFAS are highly stable chemicals that accumulate in people, animals, and the environment over time, and in several cases, have been shown to cause adverse health effects.”
The RFI states that respondents may provide information for one or as many research goals below as they choose:
- The removal of PFAS from the environment, in part or in total;
- The safe destruction or degradation of PFAS;
- The development and deployment of safer and more environmentally friendly alternative substances that are functionally similar to those made with PFAS;
- The understanding of sources of environmental PFAS contamination and pathways to exposure for the public; and/or
- The understanding of the toxicity of PFAS to humans and animals.
OSTP states that it is interested in responses to the following questions:
- Should the federal government consider identifying priority PFAS when developing a strategic plan for PFAS R&D? If so, what criteria should be used to identify priority PFAS for R&D (e.g., tonnage used per year; releases to the environment per year; toxicology or other human or environmental health concerns; or national security or critical infrastructure uses)?
- Are there criteria that could be applied across the five research goals identified above, or should specific criteria be developed for each individual research goal?
- Based on the definition of PFAS in the RFI, what are the scientific, technological, and human challenges that must be addressed to understand and to reduce significantly the environmental and human impacts of PFAS and to identify cost-effective:
- Alternatives to PFAS that are designed to be safer and more environmentally friendly;
- Methods for removal of PFAS from the environment; and
- Methods to destroy or degrade PFAS safely?
- Are there specific chemistries and/or intended uses that PFAS provide for which there are no known alternatives at this time?
- What are alternatives to the definition of PFAS provided in this RFI? What are the implications of these alternative definitions on possible remediation strategies?
- What should be the R&D priorities for accelerating progress, improving efficiency, and reducing the cost of: analytical methods, detection limits, and non-targeted detection?
- What studies would yield the most useful information and address the current gaps in understanding PFAS health effects in humans (e.g., in vitro, animal toxicological, and epidemiological studies)? Which health effects should be prioritized? What additional impacts beyond health should be prioritized? Social scientific approaches are welcome in addressing this question and any others, as appropriate.
- One challenge across all research goals is PFAS mixtures and formulations. Currently, more information is needed to understand the identity, composition, occurrence, source, or effects on human health and the environment for mixtures of PFAS found in environmental media. Additionally, more information is needed to understand the best way to remediate or destroy media contaminated with multiple PFAS. What should be the R&D priorities for accelerating progress in these areas?
- What goals, priorities, and performance metrics would be valuable in measuring the success of national, federally-funded PFAS R&D initiatives relating to:
- The removal of PFAS from the environment;
- Safely destroying or degrading PFAS;
- Developing safer and more environmentally friendly alternatives to PFAS; and
- Mitigating negative human effects of PFAS, whether related to health or additional domains?
Responses are due August 29, 2022.
By Lynn L. Bergeson and Carla N. Hutton
On March 3, 2022, the White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) to support the development of a federal scientific integrity policy framework. 87 Fed. Reg. 12165. According to OSTP, the framework will include assessment criteria that OSTP and agencies can use to inform, review, and improve the content and implementation of agency scientific integrity policies. To support this framework, OSTP seeks information on: (1) how scientific integrity policies can address important and emergent issues, including diversity, equity, inclusion, and accessibility; new technologies; emerging modes of science; and coordination with related policy domains; (2) the criteria to evaluate scientific integrity policy content, implementation, outcomes, and impacts in the Executive Branch; (3) how to ensure that scientific integrity evaluation findings lead to effective iterative improvement of federal scientific integrity policy and practices; and (4) how to ensure the long-term viability and implementation of federal scientific integrity policies, practices, and culture through future administrations. Comments are due April 4, 2022.
OSTP states that this effort builds on the Scientific Integrity Task Force’s review of existing scientific integrity policies and practices, released in the January 11, 2022 report, Protecting the Integrity of Government Science. As reported in our January 13, 2022, blog item, the scientific integrity principles and best practices identified in the report “aim to ensure that science is conducted, managed, communicated, and used in ways that preserve its accuracy and objectivity and protect it from suppression, manipulation, and inappropriate influence -- including political interference.”