EDF Health

ICYMI: Secret GRAS determinations may outnumber those FDA reviews

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.)

Why It Matters

FDA’s review of GRAS safety determinations is critical to ensure food chemicals are safe. When agency scientists receive GRAS notices, they closely review them and ask notifiers tough questions about the safety of the chemical alone—and the potential consequences when that chemical is combined with other chemicals on the market.

But FDA allows companies to withdraw their notices – which they do in about 17% of cases. Sometimes companies fix the problems and resubmit the notice. FDA does not require companies to do this, however. Too many simply continue to market the chemical for food uses as GRAS without seeking further FDA review.

This is in addition to the GRAS safety determinations companies choose never to file, which leads to chemicals entering our food system without any FDA notice or review at all.

Our Take

While the GRAS system is clearly broken (something we’ve blogged about at length and the Washington Post covered in-depth back in 2014), FDA does retain the ability and the duty to monitor the marketplace to ensure unsafe chemicals that food companies claim as GRAS are kept off the market.

Unfortunately, the agency appears to lack any system to ensure that monitoring takes place. The only examples of agency action to pull industry-certified GRAS products off the market have been caffeinated alcoholic beverages and partially hydrogenated oils (aka artificial trans fat). Both were prompted, in part, by state and media calls for action.

Examples of inaction, however, are numerous and include: tara flour, COZ corn oil, Apocynun ventron, gamma aminobutyric acid (GABA), aquaequorin/Prevagen, and many more.

One of the key breakdowns that contributes to FDA’s failure to monitor is the lack of coordination between the regulatory programs in the Center for Food Safety and Applied Nutrition (CFSAN) and the inspection/enforcement programs in the Office of Regulatory Affairs (ORA).

Next Steps

In January 2023, FDA Commissioner Califf announced a proposal to reorganize the food safety program in response to stakeholder calls for action after the infant formula debacle and to a recent review of the agency by the Reagan-Udall Foundation. This review noted that one key step is to appoint a new Deputy Commissioner for Human Food. This person would have greater responsibility to coordinate efforts between CFSAN and ORA. The Commissioner’s proposal has been strongly criticized since there would be no clear line of authority between the new Deputy Commissioner and ORA.

But Commissioner Califf has stated that chemical safety is a priority, telling a reporter that “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.”1

Fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. Until the broken GRAS system is fixed, FDA will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety. Until the system is fully fixed—which includes ensuring that no chemicals enter our food system without notice to, and review by, the agency—FDA needs to be coordinating with ORA and CFSAN to proactively monitor and enforce GRAS evaluations on chemicals entering the market to ensure they are actually safe.

Go Deeper

You can learn more from these resources:

 

NOTES

1 FoodFix, January 31, 2023, edition.

Also posted in Broken GRAS, Chemical regulation, FDA, Food, GRAS, Health policy, Industry influence, Regulation / Tagged , , | Authors: , / Leave a comment

EPA’s TCE Ban: A Vital Step for Public Health

Right-to-Know sign for trichloroethylene, or TCE. Lists the health hazards of TCE.

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.”

Why It Matters

TCE causes so many different harms at such low levels that, when finalized, this action will bring widespread benefits to countless individuals.

TCE can cause multiple types of cancer – kidney cancer, liver cancer, and non-Hodgkin’s lymphoma cancers. In addition, exposure to TCE can cause kidney, liver, and neurological damage, harm the immune system and reproduction, and result in heart defects in developing fetuses.

What is particularly concerning is that some of the harm TCE causes—such as to the immune system and fetal heart development—occurs at extremely low levels that often go unnoticed.

People can be exposed in many ways: from chemical plants producing and releasing TCE into the environment; facilities using it for degreasing parts; and the intrusion of TCE into people’s homes, schools, and workplaces from industrial contamination of soil and groundwater.

“The only inconsistency with the science lies in the chemical industry’s misleading claims.”—Maria Doa, PhD, EDF Senior Director for Chemicals Policy

Our Take

We applaud EPA for taking this long-overdue action.

The extensively peer reviewed science clearly demonstrates the high toxicity of TCE and that exposure to even small amounts of TCE can harm a person in multiple ways. The only inconsistency with the science lies in the chemical industry’s misleading claims.

Once again, the chemical industry is resorting to the same tired playbook—attempting to downplay the dangers of TCE—all in the interest of protecting their profits. There is no valid justification to continue subjecting people to the perils posed by this pernicious chemical.

It is imperative that EPA expeditiously finalize its ban of TCE.

Go Deeper

Read our previous blogs on TCE.

Download a PDF of this blog post.

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

Unleaded Food: FDA acts quickly on contaminated cinnamon applesauce

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

Why It Matters

Lead levels in the puree ranged from 1,900 to 5,100 parts per billion (ppb). A single serving with 2,000 ppb exposed children to a lead level 64 times greater than FDA’s maximum daily intake of 2.2 micrograms/day (µg/day) for a child and 11 times greater than the 12.5 (µg/day) for an adult.

We will continue to note that there is no safe level of exposure to lead—making it toxic at any age, with heightened concern for children aged six and below. In homes without lead pipes or lead paint, diet is the primary source of lead exposure for young children. Read More »

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

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

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: , / Leave a comment

Now’s the Time—How EPA Can Use TSCA to Turn Off the PFAS Tap

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

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