EDF Health

Time for a New Age for New Chemicals

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.

Also posted in Chemical regulation, TSCA / Tagged , , , | Authors: / Leave a comment

Broken GRAS: Companies ignore FDA draft guidance; Bias & conflicts of interest prevail in safety determinations

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 2015-2020that 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 »

Also posted in Broken GRAS, Conflict of interest, FDA, Food / Tagged , , , | Authors: / Comments are closed

Fatally Flawed: EDF & partners call on EPA to revoke approval for new chemicals with shocking health risks

 

 

Black & white photo of a refinery, billowing smoke.

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

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.

Why It Matters

First, the statement is at odds with the available evidence: there is no record of FDA reviewing the safety of THP as a GRAS substance. The only interaction we are aware of was in 2013, when Sabinsa voluntarily asked FDA to review its GRAS determination for BioPerine to be used as a flavoring agent. A few months later, Sabinsa sent a letter asking FDA to stop reviewing the safety assessment (also known as a “cease to evaluate” request). After that, there does not appear to have been any interactions between Sabinsa and FDA regarding either of its products.

Second, the statement mistakenly claims that FDA approves GRAS substances when in fact the agency issues an opinion when a manufacturer requests a review by FDA. In its opinion letters, the agency makes clear that it is not an approval.

Third, a decade ago, we identified significant safety concerns with BioPerine, the only product that FDA has had an opportunity to review although, as previously noted, that review was halted when Sabinsa withdrew its request for review. As a result, FDA did not issue an opinion. In 2013, the authors, on behalf of the Natural Resources Defense Council at the time, sent a letter to FDA listing many issues with the GRAS notice that Sabinsa had withdrawn, including:

  • Lack of toxicology testing for the extract, which is more than 95% piperine, the active ingredient.
  • Failure to correctly interpret toxicity data in the literature, which showed that piperine is toxic to the immune system and causes reproductive and developmental toxicity in animals and cell-based studies.
  • Dismissal of human studies showing that piperine affects the metabolism of other compounds including medications by increasing their bioavailability.

Piperine is “reported to enhance the bioavailability of drugs, nutrients, and herbal extracts,” and Cosmoperine is marketed as a “bioavailability enhancer.”

The presence of these substances in food could potentially increase the bioavailability of medications in ways that healthcare professionals prescribing the drug could not anticipate. As a result, the drug might have adverse health effects from the higher effective dose.

Our Take

It is clear that BioPerine and the related Cosmoperine are highly concentrated extracts from black pepper that have been neither adequately tested nor adequately evaluated to determine their uses are safe.

We have published multiple articles describing the problems with the GRAS process. Among the most egregious of FDA’s failures are:

  • Allowing companies to withdraw a GRAS notice where the company realizes that FDA may not give it a favorable review;
  • Not proactively making the concerns publicly available[2] about the safe use of the substance;
  • Not conducting any apparent post-market oversight when FDA has concerns about the safety of a chemical.

In our Broken GRAS series we show many examples of chemicals of dubious safety that stealthily entered the food supply without any warnings.

In January, FDA Commissioner Califf announced a “new and transformative vision for the FDA Human Food Programs” These are important steps, but a real measure is ensuring that GRAS substances where FDA had safety concerns are subjected to strong oversight to protect American’s health by restricting the use of harmful chemicals such as THP.

Next Steps

We have alerted FDA to the claims and asked the agency to quickly investigate this product and its uses to protect consumers–especially those who might be using one of the medications that are affected by THP. FDA responded that it “will take a closer look and make sure this information is routed as appropriate.” We will continue to press FDA to act expeditiously to get products like this one off the market until the agency can verify its safety.

[1] We don’t know the relationship between Prime Research Reports and Sabinsa and have not heard back on a request for information.

[2] The information may be available through a Freedom of Information Act but that does not mean it is publicly available since only the requester gets the information.

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

Carts Before Horses: Vinyl Institute Calls For EPA To Evaluate Risk Without Data

Horse attached to the wrong end of the cart. Caption says "Whose bright idea was this again?"

What’s New?

Yesterday, (March 27), EDF—together with the National Wildlife Federation—filed a “friend of the court” brief in the case of Vinyl Institute v. EPA. We expressed our support for EPA’s authority to order companies to 1) Conduct health and safety studies for their chemicals and 2) Turn over those test data to EPA when the agency is evaluating risks the chemicals may pose to humans, wildlife, or the environment.

The Vinyl Institute, which lobbies for companies making vinyl chloride and other chemicals used to make PVC plastic, disagrees. It brought a case against EPA on behalf of its members, asking the U.S. Court of Appeals in Washington, DC, to overturn EPA’s order to test 1,1,2-trichloroethane—a chemical known to harm living beings.

Why It Matters

This case could affect EPA’s ability to order companies to conduct health and safety studies for their chemicals, and, by extension, the agency’s ability to regulate those chemicals. Our brief to the court examines the history that led Congress to grant EPA authority to issue test orders and explains why it is critical for EPA to retain this authority.

The Backstory

The Toxic Substances Control Act (TSCA), the nation’s primary chemical law, was first enacted in 1976. For decades afterwards, EPA managed to collect test data for only a few chemicals; in some years, EPA collected no test data from companies at all.

The original TSCA law required EPA to go through lengthy procedures and make risk determinations about a chemical before it could seek any data from companies. Members of Congress recognized this was a no-win position for EPA and tried for many years to change the law. In 2016, Congress enacted major bipartisan reforms to TSCA, giving EPA power to order companies to test their chemicals when the agency needs data to complete risk evaluations of those substances. This change was lauded by members of Congress and many others as one of the most important improvements to TSCA.

The Current Case

EPA has designated 1,1,2-trichloroethane as a “high priority” for risk evaluation and possible regulation under TSCA. The agency issued the test order because it has some data indicating that the chemical is toxic to birds—but EPA needs more information on just how toxic it is to understand the risks. The Vinyl Institute essentially argued that EPA should have shown the risk to birds before it issued a test order—a classic case of putting the cart before the horse.

On behalf of several multibillion-dollar companies, which produce vinyl chloride and are part of the case, the Vinyl Institute also complained about the cost of the test.

What’s Next?

The court will review the briefs and issue a decision. In the meantime, chemical companies are challenging other EPA testing orders in court, and we are keeping a close eye on those cases. We will continue supporting EPA’s ability to exercise the authority Congress gave it–along with the ability to gather the information it needs to understand how chemicals pose risks to us and the environment and it can take the actions necessary to protect us.

Go Deeper

Read the briefs for the case Vinyl Institute v. EPA:

Also posted in Public health, TSCA / Authors: / Comments are closed

EPA Should Address Cumulative Risks from New Chemicals

Names of blog authors: Maria Doa, PhD, Sr. Director, Chemicals Policy, and Lariah Edwards, PhD, Associate Research Scientist, Columbia University

What’s Happening? EPA’s current safety assessments of new chemicals proposed for market entry often fall short of effectively protecting all members of the public from risk because they don’t consider that we may be exposed to closely related chemicals that cause similar harms.

Recent Example: EPA proposed rules requiring notification of significant new uses for a group of new chemicals. Two of these chemicals, known as trimellitate esters, are very closely related, and would be expected to cause very similar harms and have very similar uses—so that people exposed to one chemical would likely be exposed to the other. Despite this, EPA did not consider the chemicals together or even use the information it had on one to inform its understanding of the safety of the other.

This doesn’t make sense.

Even though EPA said that one chemical was intended to be used as a lubricant and the other as a plasticizer (a chemical that makes plastics more flexible), it is likely that both could be used as a plasticizer or a lubricant. They may be used together or turn up in similar consumer products, such as a car’s dashboard. Further, both chemicals are very closely related to yet another plasticizer used in the auto industry, but it appears that EPA considered these nearly interchangeable chemicals in isolation from one another.

Items that require plasticizers for production. They include seats in cars, rain boots, a garden hose, medical gloves, an exercise ball, and rolls of wallpaper.

In fact, under the Toxic Substances Control Act (TSCA), EPA is required to identify such “reasonably foreseen uses,” such as ending up in the same product.

Why It Matters: Evaluating chemicals in isolation likely underestimates the exposures and risks workers, consumers, and frontline communities face. Doing so also fails to make use of all the best available science, since information on each of these two chemicals (as well as the one already being used) could inform the safety determination for the other.

Considering the combined risks from similar chemicals is not new. EPA is already doing this for another group of closely related chemicals—phthalates. Phthalates have long been widely used in a range of consumer products and are detected in almost all our bodies. Phthalates are known to impact male reproductive health. EPA is joining the ranks of other federal agencies that have considered the cumulative risks they pose.

Our Take: EPA should not stop at phthalates. They can and should be incorporating cumulative approaches from the very beginning of a chemical’s regulatory life. Considering the impact of combined exposures does not need to be complicated and EPA could make such a consideration without much extra effort.

EPA can take a first step toward doing this by considering the potential for cumulative risks when finalizing its regulation on the significant new uses for these two new closely related chemicals.

Go Deeper: Read EDF’s response to EPA’s proposed new SNURs. And check out our Cumulative Risk Assessment Framework.

Also posted in Environment, Health science, Public health, TSCA / Comments are closed