By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Environmental Protection Agency opened a 30-day comment period on nominations for candidates to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). According to EPA, there are currently 17 SACC members, with eight membership terms that will soon expire. Biographies for all candidates under consideration are available online. In addition, biographies for current SACC members are available on the SACC website. Comments on the nominations are due April 7, 2023. EPA states that it will use comments received to assist it in selecting new members of the SACC by June 2023.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
In February 2023, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), published a summary of learnings and potential recommendations on broadening public engagement in the federal regulatory process. The learnings and recommendations were developed from written submissions and a public engagement session in November 2022 with hundreds of participants. OIRA invites feedback on the recommendations as it continues to consider them, with these questions as a starting point:

• Which of the recommendations would most effectively broaden public engagement in the federal regulatory process, especially from members of underserved communities and those who do not typically participate in the regulatory process? Are there recommendations that are not helpful?
   
• Are there obstacles or barriers to greater public participation, especially for underserved communities, that are not addressed by these recommendations? If so, are there other recommendations that we should consider?
   
• Are there existing materials, such as guides or tools, that would be especially effective in revising and potentially implementing these recommendations? What new tools or guidance are needed?
   
• How can intermediaries -- such as trade associations or coalitions -- be helpful in reaching individuals and small organizations or businesses, where have they been successful in doing so, and where might they be insufficient?

Interested members of the public can submit their feedback to .(JavaScript must be enabled to view this email address) as written feedback or recorded audio and video submissions. OIRA will be actively reviewing any submissions received through 5:00 p.m. (EST) March 10, 2023. OIRA states that it is also planning an additional virtual listening session during which members of the public can provide their views on these recommendations, to be held 3:00 p.m. - 4:30 p.m. (EST) on Tuesday, March 7, 2023.

• Email This
• Print

By L. Claire Hansen, Legal Intern
 
On January 27, 2023, plaintiffs in the Southern District of New York announced their displeasure with the inconvenient fact that Tom’s Wicked Fresh! mouthwash contains measurable concentrations of PFAS. They channeled their displeasure by bringing a class action suit against Colgate-Palmolive Company and Tom’s of Maine, Inc. for fraud and unjust enrichment based on several state consumer protection laws, the federal Magnuson-Moss Warranty Act, and common law tort. Plaintiffs assert that “natural” Tom’s Wicked Fresh! mouthwash is anything but natural, in that it contains per- and polyfluoroalkyl substances or “PFAS,” a category of synthetic chemicals are not natural.
 
Plaintiffs claim that Tom’s Wicked Fresh! mouthwash is a much-touted “natural” product and that its marketers have unjustly financially gained through deceptive and fraudulent marketing practices by leading consumers to believe that their product is natural when it actually contains hazardous substances. PFAS are not included in the product’s list of nine ingredients. That an amazing range of incidental contaminants (which PFAS could well be considered) end up in food and drug products that the U.S. Food and Drug Administration (FDA) expressly excludes from ingredient disclosure, including whole insects, rodent hairs, insect fragments, and rodent dung, is apparently beside the point because, presumably, it is natural. The Center for Disease Control and Prevention (CDC) states that PFAS is dangerous because these substances do not break down and linger stubbornly in the environment, they can travel through soil and groundwater, and they build up (bioaccumulate) in fish, wildlife, and humans.
 
Plaintiffs went looking for PFAS when they sent a mouthwash sample out for independent testing. Given their ubiquity, PFAS unsurprisingly were detected. Perfluorooctanoic acid (PFOA), a particularly potent variant and standard bearer of the PFAS class of toxic substances, was detected. The U.S. Environmental Protection Agency’s (EPA) recommended lifetime health advisory level for PFOA is 0.004 parts per trillion; the tested sample revealed that “the Product contains PFOA in amounts more than 100 times the EPA’s recommended levels [emphasis in original].”
 
To establish fraud, plaintiffs must prove defendants intentionally added PFAS to its product or that the defendants knew PFAS were in their product and failed to take corrective measures to remove it. There are at least two possible PFAS contamination sources. The first is if Tom’s used a fluorinated container to transfer the mouthwash before it was bottled. PFAS is known to migrate from fluorinated containers because of the fluorination process. The second possibility is through secondary contamination from plant process water used to make the mouthwash. Additional testing is needed to identify the source. Arguably, in either case, Tom’s did not engage in fraudulent business practices. It may well not have known PFAS contaminated its product because either migration pathway is speculative or completely unexpected. Given their ubiquity, every geographic area of the world and most things in it are contaminated with PFAS, including everyone reading this blog.
 
Why does this matter? One very real outcome of the case, win or lose, is the end of “natural” product claims. Can beef be “natural” if the cow that it came from is PFAS-contaminated? What about that fresh, “natural” spring water we all love -- does it contain PFAS? Probably, but does that make it not “natural”? We will leave for another blog whether a win for the plaintiffs punishes wrongly businesses that are victims of PFAS manufacturers and others whose PFAS products are now the source of seemingly endless contamination, litigation, and regulation.
 
Alternatively, if defendants reasonably believed, or should have known, that there were detectable PFAS in their supply chains and failed to act to remove them, then the claims may stick. Fluorinated containers are associated with PFAS contamination. If the defendants use such container technology, query whether they exercised due care in failing to use other technologies. If the contamination was from plant process water, they could and perhaps should have tested the intake water and filtered the PFAS out to ensure product purity.
 
A jury will decide. Even before it does, though, “natural” product claims may be a thing of the past. Businesses can be expected to be understandably nervous about passing the PFAS purity test.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our October 19, 2021, memorandum, the U.S. Environmental Protection Agency (EPA) published the PFAS Strategic Roadmap in October 2021, “laying out a whole-of-agency approach” to addressing per- and polyfluoroalkyl substances (PFAS). As part of the Roadmap, EPA committed to engage with communities in each EPA region to understand better their experiences and challenges in addressing PFAS contamination. To help inform EPA’s ongoing work under the Roadmap, EPA plans to facilitate a series of virtual community engagement sessions in 2023 for each of EPA’s ten regions. EPA states that it also plans to hold a session specifically designed to hear from its Tribal partners. The engagement sessions will provide opportunities for communities to share feedback directly with EPA regional and PFAS Council leaders to inform the implementation of the actions described in the Roadmap. Registration is now open for the following regional PFAS Community Engagement Sessions:

• February 28, 2023, at 6:00-8:00 p.m. (CST): Region 7 (Iowa, Kansas, Missouri, Nebraska, and nine Tribal Nations);
   
• March 2, 2023, at 6:00–8:00 p.m. (EST): Region 3 (Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia, and seven federally recognized Tribes); and
   
• March 8, 2023, at 6:00–8:00 p.m. (MST): Region 8 (Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming, and 28 Tribal Nations).

Registration for other regions will open soon. Stakeholders can sign up to be notified when registration for other regions is available. 

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2023, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as Special Government Employees (SGE) on a review panel under the authority of the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). 88 Fed. Reg. 9880. EPA states that selected experts will review ORD’s draft documents detailing scientific studies supporting the development of transcriptomic-based toxicity values and their implementation as a new EPA Transcriptomic Assessment Product (ETAP). According to EPA, the ETAP is a proposed ORD assessment product that uses a standardized short-term in vivo study design and data analysis procedures to develop transcriptomic-based toxicity values for data-poor chemicals. Draft documents will be provided in the BOSC docket prior to the meeting for an in-depth evaluation of:

• Literature review and scientific studies supporting the development of transcriptomic points of departure from short-term in vivo studies;
• Derivation of transcriptomic toxicity values for chronic toxicity;
• Incorporation of transcriptomic toxicity values into a new standardized assessment product that is intended for data-poor chemicals; and
• Example application of the ETAP to a data-poor per- and polyfluoroalkyl substance (PFAS).

According to EPA, the review of the draft documents detailing underlying scientific studies and implementation of ETAP by the BOSC is being performed in close coordination with a separate BOSC review of a value-of-information (VOI) analysis comparing the ETAP with traditional human health assessment practices. EPA states that the VOI analysis is intended to evaluate the public health and economic trade-offs associated with the timeliness, uncertainty, and costs of the different toxicity evaluation and assessment approaches.

The review will take place between April and July 2023. Nominations are due March 3, 2023.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023.
 
EPA states that the TSCA Inventory contains 86,685 chemicals, of which 42,170 are active in U.S. commerce. Other updates to the Inventory include new commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules and test orders). EPA notes that additionally, several hundred substances are now listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of EPA’s TSCA confidential business information (CBI) review efforts.
 
Lastly, EPA reminds TSCA submitters to check regularly for any correspondence relating to their submissions in EPA’s Central Data Exchange (CDX). EPA states that it sends “critical and time-sensitive information regarding confidentiality claims through CDX, and failing to open this correspondence can delay the Agency’s processing of those claims.”

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Applications (NURA) program is offering a free three-session training series on replacing the traditional two-year bioassay with a more effective, human-relevant carcinogenicity assessment. In “Tomorrow’s Data Today: Sunsetting the 2-year Carcinogenicity Assay,” toxicologists, risk assessors, and scientists will hear directly from other experts on the current progress among working groups, adverse outcome pathways (AOP) and integrated approaches to testing and assessment (IATA), case studies, and promising technologies to use in their weight of evidence carcinogenicity assessments. The webinars will be held:
Session 1: February 23, 2023

• Timothy McGovern, Ph.D., Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA);
• Joseph Manuppello, PCRM;
• Mirjam Luijten, Ph.D., Dutch National Institute for Public Health and the Environment (RIVM), European Partnership for Alternative Approaches to Animal Testing (EPAA) Workgroup; and
• Connie Mitchell, Health and Environmental Sciences Institute (HESI) Workgroup.

Session 2: March 2, 2023

• Gina Hilton, Ph.D., PETA Science Consortium International e.V. (PSCI);
• Susanne Stalford, Ph.D., Lhasa Ltd;
• Miriam Jacobs, Ph.D., United Kingdom Health Security Agency (UKHSA); and
• Sarah Dobreniecki, Ph.D., Office of Pesticide Programs (OPP), U.S. Environmental Protection Agency (EPA).

Session 3: March 9, 2023

• Chris Corton, Ph.D., Office of Research and Development (ORD), EPA;
• Ting Li, Ph.D., National Center for Toxicological Research (NCTR), FDA; and
• Carole Yauk, Ph.D., University of Ottawa.

Registration is now open.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 3, 2023, the release of three improved pollution prevention (P2) calculator tools -- the P2 Cost Calculator, the P2 Greenhouse Gas Calculator, and the P2 Calculator for Reductions in Hazardous Substances, Pollutants and Contaminants. According to EPA, these tools convert information on P2 activities at a business, such as reductions in energy use, into information on cost savings and pollution reductions. They help P2 grantees, technical assistance providers, and others measure environmental outcomes and economic performance related to P2 activities. EPA states that the updates to the Cost Calculator and the Greenhouse Gas Calculator include:

• Streamlined design to account more easily for fuel use;
• Instructions on how to use the calculators for grant reporting; and
• Newer data on prices and the environmental characteristics of power generation, incorporated into default values from sources including the U.S. Energy Information Administration and EPA’s Emissions & Generation Resource Integrated Database (eGRID).

According to EPA, the updates to the Reductions Calculator include expanded categories of pollutants and releases -- including hazardous materials used, hazardous wastes, air emissions, water pollutants, and solvent remanufacturing -- that EPA tracks and measures.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton

On January 31, 2023, the U.S. Environmental Protection Agency (EPA) invited nominations of scientific experts from a diverse range of disciplines to be considered for appointment to the EPA Science Advisory Board (SAB). 88 Fed. Reg. 6255. The SAB is a chartered Federal Advisory Committee (FAC) that provides independent scientific and technical peer review, consultation, advice, and recommendations to the EPA Administrator on the scientific bases for EPA’s actions and programs. The EPA Administrator appoints members for a two- or three-year term, and the members serve as Special Government Employees who provide independent expert advice to EPA. Nominations are due March 2, 2023.
 
According to the notice, members selected to the chartered SAB may also be asked to participate on the following standing committees of the SAB:

• The Agricultural Science Committee, which provides advice on matters that have been determined to have a significant direct impact on farming and agriculture-related industries;
• The Chemical Assessment Advisory Committee (CACC), which provides advice on EPA guidance documents, methodologies, and assessments that evaluate human health effects resulting from exposure to environmental hazards, as well as selected toxicological reviews of environmental chemicals available on EPA’s Integrated Risk Information System (IRIS);
• The Climate Science Committee, which provides advice on climate change science and the effects of climate change;
• The Drinking Water Committee, which provides advice on the scientific and technical aspects of EPA’s national drinking water program;
• The Economic Analysis Committee, which provides advice on the economic analysis of EPA programs;
• The Environmental Justice Science Committee, which provides advice on the scientific and technical aspects of environmental justice to improve the environment and/or public health in communities disproportionately impacted by environmental health hazards and risks; and
• The Radiation Advisory Committee, which provides advice on radiation protection, radiation science, and radiation risk assessment.

The selection criteria for the SAB and the SAB committees include:

• Demonstrated scientific credentials and disciplinary expertise in relevant fields;
• Willingness to commit time to the committee and demonstrated ability to work constructively and effectively on committees;
• Background and experiences that would help members contribute to the diversity of perspectives on the committee, e.g., geographical, social, cultural, educational backgrounds, professional affiliations; and other considerations; and
• For the committee as a whole, the collective breadth and depth of scientific expertise are considered.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On January 12, 2023, the White House Office of Science and Technology Policy (OSTP) announced the release of A Framework for Federal Scientific Integrity Policy and Practice, “a roadmap that will help strengthen scientific integrity policies and practices across the federal government.” The framework builds on the assessment of federal scientific integrity policies and practices described in the January 2022 report, Protecting the Integrity of Government Science, and draws from extensive input from federal agencies, as well as from across sectors, including academia, the scientific community, public interest groups, and industry. According to OSTP, the framework has several key components that federal departments and agencies will use to improve scientific integrity policies and practices, including:

• A consistent definition of scientific integrity for all federal agencies;
• A model scientific integrity policy to guide agencies as they build and update their policies; and
• A set of tools to help agencies regularly assess and improve their policies and practices.

The framework requires all agencies to designate a Scientific Integrity Official (SIO) and agencies that fund, conduct, or oversee research to designate a Chief Science Officer (CSO), and it establishes the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity to oversee implementation of the framework and evaluate agency progress. Agencies are directed to adopt the following timeline:

• Within 60 days from public posting of the framework: Agencies should submit new or updated agency and department draft scientific integrity policies for review by OSTP and the Subcommittee via the mailbox .(JavaScript must be enabled to view this email address);
• Within 120 days from public posting of the framework: OSTP and the Subcommittee will complete the reviews using the framework’s critical policy features for assessment;
• Within 180 days after public posting of the framework: Each agency should provide an opportunity for public input on its scientific integrity policies and practices, such as through a listening session or request for comment on its draft policy;
• Within 270 days from public posting of the framework: Final policies are due to OSTP. OSTP will compile and make public all agency policies, as well as all agencies’ designated CSOs and SIOs on a federal web page;
• Within 360 days from public posting of the framework and every two years thereafter: All agencies report to OSTP on their progress toward implementing the Framework; and
• For calendar year 2023 and annually thereafter: Each agency should publish, consistent with any requirements related to national security and privacy as well as any other applicable law, an annual report on the agency’s website.

• Email This
• Print