EDF Health

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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EPA: Now’s your chance to get foxes out of the henhouse

By Samantha Liskow / Published: October 10, 2023

Rooster facing fox on a black background

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

What Happened?

EPA recently proposed new regulations for its safety reviews of new chemicals under our nation’s main chemicals law, the Toxic Substances Control Act (TSCA). With this action, the agency has a big chance to solve major problems that have undermined scientific integrity, transparency, and public confidence in EPA’s ability to ensure the safety of new chemicals. Unfortunately, the proposed regulation that EPA put out for comment this year falls far short of this goal.

EDF has joined with other organizations, including AFL-CIO, the American Federation of Teachers, and the National Resources Defense Council, in a letter urging EPA to make fundamental changes (PDF, 178KB) to these proposed regulations. One of the most important is this: the agency should end its longstanding practice of sharing about the risks of new chemicals with only the companies that make them—and allowing those companies to dispute the results.

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Also posted in Chemical regulation, TSCA / Tagged , , , , , | Authors: / Read 1 Response

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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Also posted in Chemical regulation, TSCA / 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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Fatally Flawed: EDF & partners call on EPA to revoke approval for new chemicals with shocking health risks

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: August 10, 2023

 

 

A sepia-toned image showing a factory with dark smoke billowing out of multiple smokestacks.

What Happened?

EDF and other environmental groups recently asked the Environmental Protection Agency (EPA) to withdraw the approval it issued for a group of new chemicals. This approval, also known as a consent order, allows Chevron to create fuels at its refinery in Pascagoula, Mississippi, by using oils produced through a process of superheating plastic waste to break it down (a process known as pyrolysis). The consent order also allows for the use of these fuels derived from waste plastic at more than 100 locations. ProPublica published an article on the issue on August 4, 2023.

Why It Matters

EPA is required by law to provide protections against unreasonable risks posed by new chemicals. But in the consent order EPA approved the production and use of these new chemicals despite significant health risks. One of the chemicals posed a 1 in 4 risk of developing cancer for people exposed to it. Another chemical carried risks of a 7 in 100 cancer risk from eating fish contaminated by it and a greater than 1.3 in 1 cancer risk from inhaling it.

When asked about the shockingly high cancer risks it estimated, EPA claimed its cancer risk assumptions were overly conservative but failed to provide any information about what it believes are the actual risks and pointed to undefined controls under other laws as controlling the risks.

Until now, the acceptable risk standard for cancer in the general population has been 1 in 1,000,000. The risk levels EPA identified are up to 1,000,000 times greater than that. Read More »

Also posted in Adverse health effects, Chemical exposure, Chemical regulation, Frontline communities, Health hazards, Health policy, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Tagged , , , , | Authors: / Comments are closed

Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 11, 2023

Brown glass vial surrounded by pepper corns

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

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Also posted in Adverse health effects, Broken GRAS, FDA, Food, Health hazards, Risk assessment, Risk evaluation / Tagged , , , , , , , | Authors: , / Read 1 Response