EDF Health

Selected tag(s): Risk assessment

EPA’s new chemical regulations: Backtracking on PBTs

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: November 15, 2023

NOTE: This is the fifth in a series about EPA’s regulation of new chemicals. See below under Go Deeper for links to the other blogs in the series.

What Happened?

The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of the proposed provisions would govern which persistent, bioaccumulative,1 toxic chemicals (PBTs) should undergo a full safety review.

Why It Matters

This proposed approach would exclude certain PBTs from a full new chemical safety review. This is a concerning step backward in addressing the risks from these chemicals.

PBT chemicals do not break down readily from natural processes and raise special concern because of their ability to build up in both the environment and in people and other organisms. Even small releases of these long-lived and bioaccumulative toxic chemicals can pose long-term risks to human health and the environment. Notable PBTs—such as DDT, which affects reproduction, and methyl mercury, which is a powerful neurotoxin—impacted whole ecosystems across the United States, including the Great Lakes.

View of Lake Michigan

View of Lake Michigan Photo credit: Maria Doa

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Posted in Adverse health effects, Chemical exposure, Chemical regulation, Health hazards, Health policy, Neurotoxicity, PBTs, Regulation, Risk assessment, Rules/Regulations, TSCA / Also tagged , , , , | Authors: / Comments are closed

New Chemicals Rule: EPA must require more info from industry

By EDF Blogs / Published: November 3, 2023

By Maria J. Doa, PhD, Senior Director, Chemicals Policy, and Greg Schweer, Consultant

NOTE: This is the third in a series about EPA’s regulation of new chemicals. See below under Go Deeper for links to other blogs in the series.

Chemical worker in hazmat suit and full-face respirator making new chemicals for industry.

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

Industry often waits until late in the review process to submit information—which means that EPA may spend a significant amount of time and effort to revise its risk assessments to incorporate the new information.

EPA has a major opportunity to improve the New Chemicals Program as it crafts these revised regulations. Requiring industry to provide additional “known or reasonably ascertainable information” as required by the law is an important component of this rule. This should reduce the amount of assessment “rework” the agency currently conducts.

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Posted in Chemical regulation, Industry influence, Risk assessment / Also tagged , , | Authors: / Comments are closed

Industry is scapegoating EPA for new chemical review delays

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: October 17, 2023

What’s Happening?

The chemical industry has an extensive—and ongoing—history of complaining about how long it takes EPA to do new chemical safety reviews.

The irony is that industry is the very player causing the delays in EPA’s review process. Clear data indicate that chemical manufacturers are primarily responsible for the length of EPA’s reviews and the backlog of cases.

Illustration of a goat looking anxious as 6 fingers point at it from outside the frame

Why It Matters

One of EPA’s vital roles is to assess the safety of new chemicals before they enter the market.

Industry’s outcry about a backlog serves as a smokescreen to pressure EPA into swiftly approving new chemicals even when they may not be safe. This would put us all at risk, particularly those who are more susceptible or maybe more highly exposed, such as children, pregnant people, and people who live and work in fenceline communities.

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Posted in Chemical regulation, Industry influence / Also 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 / Also tagged , , | Authors: / Read 2 Responses

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, Industry influence / Also tagged , , | Authors: / Comments are closed

New Approach Methodologies Should Adhere to TSCA Standards

By Susanne Brander, PhD, Senior Contributing Scientist / Published: August 15, 2023

What’s New?

EPA recently asked its Board of Scientific Counselors (BOSC), comprised of experts in the fields of toxicology and environmental chemistry, to make recommendations on implementing new approach methods (NAMs) for testing the safety of new chemicals.

NAMs encompass a wide array of new evaluation strategies, including testing cell lines or invertebrates (rather than mammals); using computational approaches; and estimating potential harms of new chemicals by looking at existing toxicity data on similar substances.

Why It Matters

EPA announced in 2019 that it would be redirecting resources towards developing NAMs to replace those studies. The looming concern is the possibility that NAMs may miss effects that whole animal mammalian testing accounts for and generate false negatives — potentially allowing toxic chemicals to appear in consumer products or end up in our environment.

This could happen because relying only on NAMs or using data from one chemical to predict how a new one might behave opens the door to missing negative effects. NAMs could also cause evaluators to miss opportunities to use the Toxic Substances Control Act (TSCA), the nation’s primary chemical safety law, to limit toxic chemical exposures. Read More »

Posted in Chemical regulation, Cumulative risk assessment, Emerging science, Emerging testing methods, Frontline communities, Health science, New approach methods (NAMs), Risk assessment, Risk evaluation, TSCA / Also tagged , | Authors: / Comments are closed