Monthly Archives: June 2024

First things first: vinyl chloride data updates and our case for stronger evaluations

NOTE: This is the first of a series about EPA’s prioritization of existing chemicals. 

 What Happened? 

EPA recently announced it had initiated the prioritization process for five chemicals for upcoming risk evaluation.  One of the chemicals, vinyl chloride, is a highly toxic chemical known to cause liver toxicity and liver cancer in humans. The other four chemicals are also carcinogens and cause other toxic effects such as harms to pregnant women and infants.  

We have added these five chemicals to our Chemical Exposure Action Map. Our map shows releases of TSCA high priority chemicals, focusing on three major categories of health harms from cumulative exposure to these chemicals: cancer, developmental harm, and asthma.  U.S. map showing chemical facilities across the nationWhy It Matters 

Prioritizing a chemical as high priority is a key step in the process of evaluating and managing its unreasonable risks under TSCA.  The factors and data that EPA considers when prioritizing chemicals affects whether EPA designates a chemical as a high priority and how effectively the Agency will be able to assess its risks, especially to more highly exposed individuals and those more susceptible to the chemicals, like fenceline communities. 

We support the designation of these five chemicals, particularly vinyl chloride, as high-priority chemicals for evaluation.  However, as we explain in our recent comments, EPA can improve its prioritization process to consider the more real-world risks faced by people who are more highly impacted by these toxic chemicals.   

 Our Take 

EPA can improve its prioritization in two important ways.  

First, EPA should systematically prioritize chemicals released or used together that cause the same toxic harms.  Considering the cumulative risk posed by chemicals that cause the same harm provides a more complete and real-world picture of the risks fenceline communities face because exposure to multiple chemicals causing the same or similar health harms increases the risk of serious health problems.  

 Second, in prioritizing chemicals and evaluating the risks from these chemicals, EPA should consider exposures from accidental releases, including transportation accidents such as from the East Palestine, Ohio train derailment.  In the past, EPA has generally not considered these exposures despite the significant contributions they can have to the chemical’s risk. 

EPA has a major opportunity to improve its prioritization and evaluation processes so that it can develop a fuller picture of the risks posed by toxic chemicals. This would provide the Agency with the basis to develop regulations that will more fully protect human health and the environment, including for those people at greatest potential risk, like fenceline communities.  

What’s Next? 

EPA is now in the process of determining whether vinyl chloride and the other four chemicals the Agency is assessing should be designated as high priority chemicals.  If they are designated as high priority, EPA will begin risk evaluations for these chemicals.   

In our next post, we will recommend ways EPA can improve its prioritization process by incorporating cumulative risk analyses and considerations. 

Posted in Chemical exposure, Cumulative risk assessment, Risk evaluation / Authors: / Comments are closed

Broken GRAS: How a food award competition revealed a secret GRAS ingredient

 

What happened

The Good Food Foundation recently announced its annual awards recognizing foods with both superior taste and responsible business practices, sparking controversy when a plant-based blue ‘cheese’ product was initially a finalist in the cheese category, then was disqualified and removed from the list of finalists. According to the foundation, the product was disqualified because one of the ingredients, kokum butter, had not been designated as GRAS (generally recognized as safe) by the Food and Drug Administration.

 

Why it matters

Kokum butter is derived from the seeds of a kokum tree’s fruit, primarily cultivated in India. The substance is not found in any of FDA’s lists of ingredients either approved or reviewed for safety. Someone somewhere determined that the use of kokum butter in food is GRAS. However, who made that determination, when, and the basis for the decision are unknown.  For example, how much of it is safe to eat? Is it safe for anyone—children, pregnant women, people with preexisting conditions? Could it cause allergic reactions or interfere with medication? Does it leave the body quickly? Does it mimic or interfere with hormones? We just don’t know and neither does FDA.

Here’s  a quick overview of the GRAS system, which we have written about extensively in our Broken GRAS blogs.

  • “General recognition” means that a safety assessment was performed and published, and the scientific community agrees that use in food is safe;
  • GRAS substances are exempted from pre-market approval by FDA;
  • FDA has interpreted the law as allowing manufacturers to independently determine the use of a substance is GRAS without informing the agency;
  • FDA created a voluntary program for manufacturers to submit their chemical’s safety determination in the form of a GRAS notice to the agency for review;
  • Manufacturers can withdraw the request for review at any time and still claim their product is GRAS. See the decision tree below.

 

Our Take

Back in 2022, tara flour, another ingredient of unknown safety, caused more than 400 people to get sick. Like kokum butter, tara flour was not approved or reviewed for safety by FDA.

We applaud the Good Food Foundation for requiring that the ingredients used in foods competing for its awards be reviewed by FDA. It is a matter of protecting public health. We fully support, at minimum, company submissions of GRAS notifications and FDA reviews. Although we have been critical of FDA’s outdated science in safety assessment of chemicals, these notifications provide at least some degree of visibility into the food supply that otherwise is not available to the agency in charge of protecting the public.

 

Next steps

We will continue to engage with FDA to ensure the agency has the tools and resources to strengthen the oversight of companies making GRAS claims without disclosing their safety assessments. The ongoing reorganization of FDA and creation of the Human Food Program is a unique opportunity to fix the broken GRAS program so that all Americans can have confidence in the safety of the food they eat.

 

Posted in Broken GRAS, FDA, Food, General interest / Authors: / Read 1 Response