EDF Health

Selected tag(s): Industry tactics

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

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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Posted in Adverse health effects, Broken GRAS, FDA, Food, GRAS, Health hazards, Industry influence, Risk assessment, Risk evaluation / Also tagged , , , , , | Authors: , / Read 1 Response

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

A rubber stamp lies on its side to the right of the photo. To the left, you see the stamped image of a skull and crossbones and the words Toxic Substances

By Maria Doa, PhD, Senior Director, Chemicals Policy

What’s the Issue?

EPA grants exemptions from full safety reviews for approximately half the new chemicals submitted by the chemical industry. Once those exemptions are granted, EPA very rarely revises or revokes them—even in the face of new information.

The Toxic Substances Control Act allows EPA to grant an exemption from a full safety review only if it determines that the chemical will not present an unreasonable risk. That’s a high standard—and one that many exemptions do not meet.

Why it Matters:

  • The chemical industry takes maximum advantage of exemptions given the abbreviated safety review and the industry’s ability to keep their use of new chemicals under the radar. For example, the chemicals that get exemptions don’t go on the national inventory of chemicals that are in use.
  • For years, EPA has granted exemptions for chemicals that can have long-term negative impacts on human health and the environment. They include hundreds of exemptions for PFAS, “forever chemicals” known to contaminate our water supplies and farmland. And it’s not just PFAS. EPA has granted exemptions for other types of persistent, bio-accumulative, toxic (PBT) chemicals that can have lasting impacts on people and the environment.
  • These exemptions often contradict TSCA’s requirement that EPA consider the risks from a chemical throughout its lifecycle. That includes the risks for vulnerable groups who may be more susceptible to the chemical or who are more highly exposed, such as frontline communities.
  • EPA does not typically consider the cumulative impacts of multiple exempted chemicals on frontline communities, consumers, or the environment.

Our Take: EPA has an important opportunity to address overuse of TSCA exemptions.

Next Steps:

  • EPA should revisit the exemptions it has already granted. The agency should determine that chemicals truly do not present an unreasonable risk—particularly to vulnerable populations—throughout their lifecycles. EPA should focus first on chemicals that can have long-lasting impacts on health and the environment, like PFAS and other PBTs.
  • Before granting any new exemptions, EPA should consider the combined impacts throughout the lifecycle of these chemicals on all stakeholders, especially frontline communities. EPA Administrator Regan recently said EPA would be embedding environmental justice into the DNA of EPA. This is another opportunity for EPA to do just that.
Posted in Frontline communities, Industry influence, PFAS, Public health, TSCA / Also tagged , , , , , | Authors: / Comments are closed

EPA to release assessment of toxic formaldehyde, rejects industry’s tired delay tactics

Maria Doa, Ph.D., Senior Director, Chemicals Policy 

The EPA will release a draft Integrated Risk Information System (IRIS) assessment of formaldehyde, a key scientific review that identifies and characterizes the hazards from chronic exposure to this known carcinogen. The draft assessment, due to be published tomorrow, will be reviewed by the National Academies of Science, Engineering and Medicine (National Academies).

We welcome the EPA’s decision to issue its formaldehyde assessment. Release of the assessment is a win for scientific integrity that follows years of pressure from industry groups and efforts during the previous administration to suppress the assessment. 

The EPA’s IRIS program is the gold standard for identifying and characterizing the hazards that result from exposure to chemicals. Its findings are essential to informing health-based standards that protect frontline communities, workers, children, consumers and more.   Read More »

Posted in Health policy, Health science, Industry influence, Public health / Also tagged , , | Comments are closed

Shifting the burden for toxics with a sneaky website: one more reason Dourson shouldn’t lead EPA toxics office

Jack Pratt is Chemicals Campaign Director

[Use this link to see all of our posts on Dourson.]

With Congress back from recess, it is slated to take up the nomination of Michael Dourson to run the toxics office at EPA. Here are links to our recent blog posts documenting why we are deeply concerned about his nomination:

Starting with work he did for the tobacco industry, Dourson has made a career downplaying concerns about chemicals, from harmful pesticides to cancer-causing solvents, paid for that work by the same companies that make or use those chemicals.

In addition to his work as a toxicologist-for-hire, Dourson and his firm, TERA, have provided more public-facing services.  One of these, done with funding from the American Chemistry Council, was the “Kids+Chemicalsafety” website, now defunct, but still available online at the Internet Archive.

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Posted in Health policy, Regulation, TSCA reform / Also tagged , , | Comments are closed

EPA IRIS program requests conflict-of-interest disclosures by commenters

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst

EPA’s Integrated Risk Information System (IRIS) is now requesting that persons who make oral comments at its bimonthly meetings or submit written comments on its documents disclose whether they have “financial relationships … with any organization(s) or entities having an interest in the assessments or issues under discussion,” and, if so, to identify the nature of that relationship, (e.g., consulting agreements, expert witness support, or research funding).   Read More »

Posted in Health policy, Industry influence / Also tagged | Comments are closed

EDF’s recommendations for IRIS conflicts-of-interest disclosures, and the strong precedents for them

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst

Our last blog post was quite lengthy and some readers may not have gotten to the recommendations we provided to EPA’s Integrated Risk Information System (IRIS) governing disclosures of conflicts of interest.  In that post, we also cited the numerous strong precedents for requiring such disclosures.

So we’re reposting here our recommendations and discussion of precedents.   Read More »

Posted in Health policy, Industry influence / Also tagged , | Comments are closed