EDF Health

ICYMI: Secret GRAS determinations may outnumber those FDA reviews

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / Published: November 22, 2023

Quote from FDA Commissioner Robert Califf, MD. "I want to throw in chemical safety as another really, really important area for the future—for humankind, really—and where science is evolving rapidly."

NOTE: This blog was originally published on our Deep Dives blog on April 13, 2023. It predates the recent reorganization efforts at FDA.

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.) Read More »

Also posted in Broken GRAS, Chemical regulation, FDA, Food, GRAS, Health policy, Industry influence, Regulation / Tagged , , | Authors: , / Comments are closed

EPA’s TCE ban: A vital step for public health

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

We only have until December 15, 2023, to show EPA we support
a full and rapid ban of all uses of TCE.

Take Action: Tell EPA–Ban TCE Now

What Happened?

The Environmental Protection Agency (EPA) has recently taken a significant step in safeguarding public health by proposing new regulations under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA) that would protect people from exposure to trichloroethylene (TCE), a highly toxic chemical that causes serious health risks. The proposed rule would ban the production, import, processing, and distribution in commerce for all uses of TCE.

Yet, despite the known dangers of TCE and the undeniable scientific evidence supporting the need for this action, the chemical industry is trying to undermine this critical regulation by incorrectly claiming the proposed rule is “inconsistent with the science.” Read More »

Also posted in Adverse health effects, Chemical exposure, Chemical regulation, Developmental toxicity, Health hazards, Industry influence, Neurotoxicity, Reproductive toxicity, Rules/Regulations, TSCA / Tagged , , | Authors: / Read 1 Response

Unleaded Food: FDA acts quickly on contaminated applesauce

By Liora Fiksel, Project Manager, Healthy Communities and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 17, 2023

What’s Happening?

The North Carolina Departments of Health & Human Services and Agriculture & Consumer Services identified WanaBana cinnamon applesauce pouches as a source for elevated blood lead levels in multiple children. They found extraordinarily high concentrations of lead (1,900- 5,100 ppb) in the products, leading to the identification of at least 34 cases of elevated blood lead levels across 22 states to date.

On October 28, 2023, FDA issued a safety alert advising that “parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test.” Three days later, the company issued a voluntary recall.

As the recall expanded, FDA transferred the investigation to its Coordinated Outbreak Response & Evaluation (CORE) Network to determine the source of lead contamination and whether additional products are linked to illnesses.

Brands under a voluntary recall. Photo credit: FDA

Brands under a voluntary recall. Photo credit: FDA

Read More »

Also posted in Chemical exposure, FDA, Food, Health hazards / Tagged , , , | Authors: , / Read 1 Response

FDA’s approach to systematic review of chemicals got off on the wrong foot

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 16, 2023

Scientist working on a digital tablet showing data on the chemical element Cadmium

What Happened?

Last month, FDA’s scientists published the toxicological reference value (TRV) for exposure to cadmium in the diet. This value is the amount of a chemical—in this case cadmium—a person can consume in their daily diet that would not be expected to cause adverse health effects and can be used for food safety decision-making. The TRV was based on a systematic review FDA scientists published last year. We will turn to the TRV itself in an upcoming blog but are focusing on the systematic review here.

In a May 2023 publication, experts in systematic reviews from the University of California San Francisco (UCSF) raised concerns about FDA’s “lack of compliance” from established procedures.

We discussed these concerns with FDA. They said:

  • “The systematic review and the TRV” publication “have both undergone external peer review by a third-party and experts in the field.” The agency expects to publish the reviews on its website, and
  • FDA “is working on developing a protocol for a systematic review of cardiovascular effects of cadmium exposure that will be published.”

Why It Matters

Systematic review is a method designed to collect and synthesize scientific evidence on specific questions to increase transparency and objectivity and provide conclusions that are more reliable and of higher confidence than traditional literature reviews. In particular, the National Academies of Sciences, Engineering, and Medicine have recommended the use of systematic reviews to establish values such as the TRV that may be used to inform regulatory decisions.

The National Toxicology Program (NTP) and others have developed specific methodologies to conduct systematic reviews. FDA’s authors said they followed NTP’s Office of Health Assessment and Translation (OHAT) handbook.

Unfortunately, FDA’s adherence to the methodology fell short on both transparency and objectivity grounds, undermining the credibility of its conclusions. Credibility is crucial because FDA’s authors stated that “this systematic review ultimately supports regulatory decisions and FDA initiatives, such as Closer to Zero, which identifies actions the agency will take to reduce exposures to contaminants like cadmium through foods.”

Read More »

Also posted in FDA, Health science / 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.

Read More »

Also posted in Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, Drinking water, Emerging science, Health policy, PFAS, Regulation, Risk assessment, Risk evaluation, TSCA, TSCA reform, Vulnerable populations, Worker safety / Tagged , , | Authors: / Read 2 Responses

New guidelines to inform EPA’s approach to cumulative risk

By Paige Varner, PhD, Scientist, Healthy Communities / Published: September 12, 2023

What’s New?

The Environmental Protection Agency (EPA) recently released and solicited public comments on its draft Cumulative Risk Assessment (CRA) Guidelines for Planning and Problem Formulation. The purpose of a CRA is to determine the combined health and/or environmental risks from multiple stressors and chemicals that can cause the same harms. These guidelines, intended to be applied to all of EPA’s programs and regions, describe how the agency will determine when to use CRAs and the steps it will take to plan them.

Why It Matters

Currently, many EPA programs assess the health and environmental risks of single chemicals, without considering the multiple chemicals that cause the same harms and non-chemical stressors we are exposed to every day. Assessing risks cumulatively, and making regulatory decisions based on this, represents real-world exposures more accurately than single-chemical stressor risk assessments. Read More »

Also posted in Chemical exposure, Cumulative impact, Cumulative risk assessment, Health policy, TSCA, Vulnerable populations / Tagged , , | Authors: / Comments are closed