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.

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Posted in Chemical regulation, Industry influence, TSCA / Tagged , , , | Authors: / Comments are closed

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

Faucet with the word PFAS flowing out of it

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.

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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: / Read 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

Clear water pouring from a pitcher into a glass.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.

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 Paige Varner, PhD, Scientist, Healthy Communities / Published: September 12, 2023

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 how a small group of individuals populate almost half of GRAS review panels. Seven individuals accounted for 46 percent of available panel positions.

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.

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Posted in Broken GRAS, Conflict of interest, FDA, Food, GRAS, 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]

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