EDF Health

Time for a New Age for New Chemicals

By EDF Blogs / Published: September 20, 2023

By Maria Doa, PhD, Senior Director, Chemicals Policy, Samantha Liskow, Senior Counsel, and Colin Parts, Legal Fellow

NOTE: This is the first of a series about EPA’s regulation of new chemicals.

What Happened?

EPA recently proposed regulations to govern how it reviews companies’ pre-manufacture notifications for new chemicals before those chemicals can go on the market.

Why It Matters

Unfortunately, as we noted in our comments to EPA [PDF, 721KB], the proposal falls significantly short of implementing the fundamental changes needed to ensure the safety of any new chemicals allowed onto the market.

Our Take

EPA has a major opportunity to improve the New Chemicals Program by crafting regulations that ensure EPA conducts robust, transparent, and objective reviews of all new chemicals that will fully protect human health and the environment, including for those people at greatest potential risk.

The agency should also align its new chemical regulations with what Congress intended when it reformed TSCA in 2016.

Among Congress’s reforms are:

  • Greater transparency on the information EPA uses and how the agency makes safety determinations for new chemicals.
  • Greater consideration of the risks from chemical exposures we all face, including risks from chemicals like the forever chemicals PFAS.
  • Greater attention by EPA in its assessments and decisions to the risks to communities more highly exposed to chemicals and those who may be more susceptible to toxic chemicals (e.g., infants).

EPA’s proposed rule misses the mark in all these areas.

EPA must improve its processes to consider all stakeholders—not just industry—in all aspects of its safety review of new chemicals. Those would include the information EPA considered, its assessment of risks, the impact of those risks, and the basis for decisions on the safety of the chemicals.

What’s Next?

This blog series will look at the ways EPA could improve its rule, including by:

  • Eliminating industry’s undue influence over new chemical reviews.
  • Requiring industry to include information in its new chemical submissions that EPA needs to make timely and truly informed decisions on the safety of new chemicals.
  • Ensuring that new chemical reviews are consistent with Congress’ mandate in amended TSCA.
  • Ensuring that decisions EPA makes consider all stakeholders, not just industry.
  • Eliminating exemptions from full new chemical reviews for PFAS and other persistent, bioaccumulative toxic chemicals known to have long-lasting effects on us.

In our next post, we will recommend ways EPA can improve its assessments by eliminating industry influence.

Go Deeper

Read our previous blogs on new chemicals.

Posted in Chemical regulation, Industry influence, TSCA / Tagged , , , | Authors: / Leave a comment

Now’s the Time—How EPA Can Use TSCA to Turn Off the PFAS Tap

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: September 18, 2023

The words P F A S are coming out of a golden faucet. The letters look like clouds or steam.

In the face of mounting evidence about the dangers posed by per- and polyfluoroalkyl substances (PFAS), one thing is clear: EPA needs to take urgent action to turn off the tap of these “forever chemicals” that have long-term consequences for our health and the environment.

As we discussed in a previous blog, it is imperative that the Environmental Protection Agency (EPA) use the Toxic Substances Control Act (TSCA) to regulate PFAS chemicals comprehensively—both those newly entering the market and those that have been in circulation for decades.

EPA Should Re-evaluate Its Past Approvals of PFAS

A cornerstone of effective regulation is the re-evaluation of earlier decisions in light of new data. EPA approved many PFAS chemicals 10–20 years ago, before there was a full picture of the pervasiveness and degree of PFAS contamination and its long-term impact. These previously approved PFAS continue to be produced and used—adding to the already substantial PFAS contamination of our environment.

In addition, the 2016 amendments to TSCA, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, significantly expanded both EPA’s authority and its obligation to regulate harmful chemicals, emphasizing potential risks to highly exposed and other vulnerable populations. Using today’s science, EPA should use its authority to re-evaluate the hundreds of previously approved PFAS, including those the agency exempted from full TSCA review.

For both past approvals and for new PFAS entering the market, EPA should take the following steps to up its game:

Use the Best Available Science
The foundation for any regulatory action must be solid science. EPA’s TSCA program should rely on the scientific expertise on PFAS across the agency. EPA’s Integrated Risk Information System (IRIS) has been evaluating PFAS, and the agency has proposed drinking water standards based on robust scientific findings. It is vital that EPA use this best available science when applying TSCA regulations to PFAS. Anything less could undermine the effectiveness of regulatory action, and the protection of human health and the environment.

Assess Cumulative Risks
TSCA provides the framework for a more inclusive understanding of chemical risks, yet EPA’s TSCA program considers PFAS chemicals in isolation. This is an outmoded strategy for protecting human health and the environment. EPA must move toward a cumulative risk assessment model, accounting for the effects of exposure to multiple PFAS chemicals, especially to vulnerable populations. Under the 2016 amendments to TSCA, the EPA has the mandate and authority to do so.

No Release is Negligible
EPA has argued that some PFAS should be of little concern if they have “negligible” releases. The argument that small releases of PFAS are inconsequential falls apart when you consider that they are environmentally mobile, highly persistent and bioaccumulative. Every release contributes to long-term, cumulative exposure. EPA should not discount the impacts of these PFAS by characterizing them as negligible. EPA should exercise its TSCA authority to ensure that all PFAS releases are treated as significant and subject to protective regulatory oversight.

Facilitate Safer Alternatives
The continued presence of harmful PFAS chemicals on the market not only risks public health but also stifles innovation. By using TSCA to restrict or ban these substances, EPA would incentivize the rapid development and adoption of safer alternatives—a step that is long overdue.

In sum, EPA has the regulatory tools it needs to turn off the PFAS tap and protect human health and the environment. By using its full authority under TSCA, EPA can ensure a future where chemicals do not compromise our health and safety. The time for decisive action is now.

Posted in Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, Drinking water, Emerging science, Health policy, Public health, Regulation, Risk assessment, Risk evaluation, TSCA, TSCA reform, Vulnerable populations, Worker safety / Tagged , , , | Authors: / 2 Responses

EPA’s Approach to 1,4-Dioxane Falls Short of Protecting Fenceline Communities

By Maria Doa, PhD, Senior Director, Chemicals Policy and Paige Varner, PhD, Scientist, Healthy Communities / Published: September 14, 2023

What’s New?

Recently, the Environmental Protection Agency (EPA) embarked on a critical Toxic Substances Control Act (TSCA) supplemental risk evaluation of 1,4-dioxane [PDF, 8.7MB]– a highly carcinogenic chemical that contaminates drinking water supplies across the country and is present in products, such as cleaning supplies and personal care products.

Ball and stick figure of a molecule of 1,4 dioxane

Ball and stick figure of a molecule of 1,4 dioxane Photo credit: Ben Mills & Jynto, Public domain, via Wikimedia Commons

This draft supplemental risk evaluation represents a significant step forward because it addresses many of the omissions from the original 1,4-dioxane risk evaluation. Unfortunately, as we noted in our comments to EPA, a closer examination reveals several shortcomings in how EPA addresses risks to fenceline communities—people living, playing, and working near industrial facilities that release toxic chemicals into the air and water. Read More »

Posted in Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, TSCA / Tagged , , | Authors: , / Read 1 Response

New guidelines to inform EPA’s approach to cumulative risk

By EDF Blogs / Published: September 12, 2023

Paige Varner, PhD, Scientist, Healthy Communities

What’s New?

The Environmental Protection Agency (EPA) recently released and solicited public comments on its draft Cumulative Risk Assessment (CRA) Guidelines for Planning and Problem Formulation. The purpose of a CRA is to determine the combined health and/or environmental risks from multiple stressors and chemicals that can cause the same harms. These guidelines, intended to be applied to all of EPA’s programs and regions, describe how the agency will determine when to use CRAs and the steps it will take to plan them.

Why It Matters

Currently, many EPA programs assess the health and environmental risks of single chemicals, without considering the multiple chemicals that cause the same harms and non-chemical stressors we are exposed to every day. Assessing risks cumulatively, and making regulatory decisions based on this, represents real-world exposures more accurately than single-chemical stressor risk assessments. Read More »

Posted in Chemical exposure, Cumulative impact, Cumulative risk assessment, Health policy, Public health, TSCA, Vulnerable populations / Tagged , , | Authors: / Comments are closed

Broken GRAS: Companies ignore FDA draft guidance; Bias & conflicts of interest prevail in safety determinations

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 6, 2023

By Tom Neltner, Senior Director, Safer Chemicals, Klara Matouskova, PhD, Consultant, and Maricel Maffini, PhD, Consultant

What Happened?

In our new study, we evaluated Generally Recognized As Safe (GRAS) notices—a total of 403 between 2015-2020—that food manufacturers voluntarily submitted to FDA for review. Our goal was to determine whether industry was adhering to FDA’s Guidance on Best Practices for Convening a GRAS Panel.

The guidance was designed to help companies comply with the law and avoid biases and conflicts of interest when determining whether substances added to food are safe and recognized as such by the scientific community. FDA published a draft of the guidance in 2017 and finalized it essentially unchanged in December 2022.Infographic showing that a small group of only 7 people takes up 46% of available positions on panels that determine whether food chemicals can be labeled Generally Recognized As Safe.

Our study found that no GRAS notices followed the draft guidance. Specifically, we also found there were high risks of bias and conflicts of interest because the companies:

  • Had a role—either directly or through a hired third party—in
    selecting panelists that likely resulted in bias and conflicts of interest.
  • Depended on a small pool of experts in which seven individuals occupied 46% of panel positions. The seven often served together, further enhancing risk of bias.
  • Relied on panels that did not realistically reflect the diverse scientific community that evaluates chemical risks to public health—which is needed to comply with the law’s requirement that there be a “general recognition” within that community that a substance is GRAS.

Read More »

Posted in Broken GRAS, Conflict of interest, FDA, Food, Industry influence / Tagged , , , | Authors: / Comments are closed

FDA says “Cookware that exhibits any level of leachable lead upon testing is prohibited.”

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 15, 2023

What’s New?

For the first time, FDA has provided guidance on how to evaluate whether metal cookware is prohibited due to lead leaching into food.

As part of an investigation to find the source of elevated blood lead levels in some refugee children, the Hazardous Waste Management Program in King County, Washington [1] encountered high lead levels in certain imported [2] aluminum cookware, including pressure cookers and pots & pans. The program attempted to bring this to FDA’s attention in late 2019, and submitted a formal product report to FDA in October 2021, after several attempts to contact an FDA representative directly.

In May 2022, the Program published a journal article about its findings; a year later, staff emailed FDA again seeking guidance. On June 1, 2023, FDA responded with a letter [PDF, 166KB] providing a method (see below) to evaluate lead in metal cookware. The agency also said:

  • “The marketing in interstate commerce, including importation, of cookware that exhibits any level of leachable lead upon testing is prohibited.”
  • “Neither lead nor lead-containing materials (e.g., metals, solder) are permitted under FDA regulations for use in contact with food.”
  • The Program should “feel free to share this letter or any of its contents with Amazon.com, Inc.,[3] and any other firms involved in the marketing or sale of cookware.”[4]

Why It Matters

Read More »

Posted in FDA, Health hazards, Lead, Risk evaluation, Vulnerable populations / Tagged , , | Authors: / Comments are closed